Medicare Program; Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012, 73026-73474 [2011-28597]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 410, 414, 415, and 495
[CMS–1524–FC and CMS–1436–F]
RINs 0938–AQ25 and 0938–AQ00
Medicare Program; Payment Policies
Under the Physician Fee Schedule,
Five-Year Review of Work Relative
Value Units, Clinical Laboratory Fee
Schedule: Signature on Requisition,
and Other Revisions to Part B for CY
2012
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
AGENCY:
This final rule with comment
period addresses changes to the
physician fee schedule and other
Medicare Part B payment policies to
ensure that our payment systems are
updated to reflect changes in medical
practice and the relative value of
services. It also addresses, implements
or discusses certain statutory provisions
including provisions of the Patient
Protection and Affordable Care Act, as
amended by the Health Care and
Education Reconciliation Act of 2010
(collectively known as the Affordable
Care Act) and the Medicare
Improvements for Patients and
Providers Act (MIPPA) of 2008. In
addition, this final rule with comment
period discusses payments for Part B
drugs; Clinical Laboratory Fee Schedule:
Signature on Requisition; Physician
Quality Reporting System; the
Electronic Prescribing (eRx) Incentive
Program; the Physician Resource-Use
Feedback Program and the value
modifier; productivity adjustment for
ambulatory surgical center payment
system and the ambulance, clinical
laboratory, and durable medical
equipment prosthetics orthotics and
supplies (DMEPOS) fee schedules; and
other Part B related issues.
DATES: Effective date: These regulations
are effective on January 1, 2012.
Implementation date: The 3-day
payment window policy provisions
specified in section V.B.3.a. of this final
rule with comment period will be
implemented by July 1, 2012.
Comment date: To be assured
consideration, comments on the items
listed in the ‘‘Comment Subject Areas’’
section of this final rule with comment
period must be received at one of the
addresses provided below, no later than
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SUMMARY:
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5 p.m. Eastern Standard Time on
January 3, 2012.
ADDRESSES: In commenting, please refer
to file code CMS–1524–FC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://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–1524–FC, P.O. Box 8013,
Baltimore, MD 21244–8013.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1524–FC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
1066 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
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courier delivery may be delayed and
received after the comment period.
FOR FURTHER INFORMATION CONTACT:
Ryan Howe, (410) 786–3355 or Chava
Sheffield, (410) 786–2298, for issues
related to the physician fee schedule
practice expense methodology and
direct practice expense inputs.
Elizabeth Truong, (410) 786–6005, or
Sara Vitolo, (410) 786–5714, for issues
related to potentially misvalued services
and interim final work RVUs.
Ken Marsalek, (410) 786–4502, for
issues related the multiple procedure
payment reduction and pathology
services.
Sara Vitolo, (410) 786–5714, for issues
related to malpractice RVUs.
Michael Moore, (410) 786–6830, for
issues related to geographic practice
cost indices.
Ryan Howe, (410) 786–3355, for
issues related to telehealth services.
Elizabeth Truong, (410) 786–6005, for
issues related to the sustainable growth
rate, or the anesthesia or physician fee
schedule conversion factors.
Bonny Dahm, (410) 786–4006, for
issues related to payment for covered
outpatient drugs and biologicals.
Glenn McGuirk, (410) 786–5723, for
issues related to the Clinical Laboratory
Fee Schedule (CLFS) signature on
requisition policy.
Claudia Lamm, (410) 786–3421, for
issues related to the chiropractic
services demonstration budget
neutrality issue.
Jamie Hermansen, (410) 786–2064, or
Stephanie Frilling, (410) 786–4507 for
issues related to the annual wellness
visit.
Christine Estella, (410) 786–0485, for
issues related to the Physician Quality
Reporting System, incentives for
Electronic Prescribing (eRx) and
Physician Compare.
Gift Tee, (410) 786–9316, for issues
related to the Physician Resource Use
Feedback Program and physician value
modifier.
Stephanie Frilling, (410) 786–4507 for
issues related to the 3-day payment
window.
Pam West, (410) 786–2302, for issues
related to the technical corrections or
the therapy cap.
Rebecca Cole or Erin Smith, (410)
786–4497, for issues related to
physician payment not previously
identified.
SUPPLEMENTARY INFORMATION:
Comment Subject Areas: We will
consider comments on the following
subject areas discussed in this final rule
with comment period that are received
by the date and time indicated in the
DATES section of this final rule with
comment period:
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(1) The interim final work, practice
expense, and malpractice RVUs
(including the physician time, direct
practice expense (PE) inputs, and the
equipment utilization rate assumption)
for new, revised, potentially misvalued,
and certain other CY 2012 HCPCS
codes. These codes and their CY 2012
interim final RVUs are listed in
Addendum C to this final rule with
comment period.
(2) The physician self-referral
designated health services codes listed
in Tables 83 and 84.
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 regulations.gov
Web site (https://www.regulations.gov) as
soon as possible after they have been
received. Follow the search instructions
on that Web site to view public
comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–(800) 743–3951.
Table of Contents
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To assist readers in referencing
sections contained in this preamble, we
are providing a table of contents. Some
of the issues discussed in this preamble
affect the payment policies, but do not
require changes to the regulations in the
Code of Federal Regulations (CFR).
Information on the regulations’ impact
appears throughout the preamble and,
therefore, is not discussed exclusively
in section IX. of this final rule with
comment period.
I. Background
A. Development of the Relative Value
System
1. Work RVUs
2. Practice Expense Relative Value Units
(PE RVUs)
3. Resource-Based Malpractice RVUs
4. Refinements to the RVUs
5. Application of Budget Neutrality to
Adjustments of RVUs
B. Components of the Fee Schedule
Payment Amounts
C. Most Recent Changes to Fee Schedule
II. Provisions of the Rule for the Physician
Fee Schedule
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A. Resource-Based Practice Expense (PE)
Relative Value Units (RVUs)
1. Overview
2. Practice Expense Methodology
a. Direct Practice Expense
b. Indirect Practice Expense per Hour Data
c. Allocation of PE to Services
(1) Direct Costs
(2) Indirect Costs
d. Facility and Nonfacility Costs
e. Services With Technical Components
(TCs) and Professional Components
(PCs)
f. PE RVU Methodology
(1) Setup File
(2) Calculate the Direct Cost PE RVUs
(3) Create the Indirect Cost PE RVUs
(4) Calculate the Final PE RVUs
(5) Setup File Information
(6) Equipment Cost per Minute
3. Changes to Direct PE Inputs
a. Inverted Equipment Minutes
b. Labor and Supply Input Duplication
c. AMA RUC Recommendations for
Moderate Sedation Direct PE Inputs
d. Updates to Price and Useful Life for
Existing Direct Inputs
4. Development of Code-Specific PE RVUs
5. Physician Time for Select Services
B. Potentially Misvalued Services Under
the Physician Fee Schedule
1. Valuing Services Under the PFS
2. Identifying, Reviewing, and Validating
the RVUs of Potentially Misvalued
Services Under the PFS
a. Background
b. Progress in Identifying and Reviewing
Potentially Misvalued Codes
c. Validating RVUs of Potentially
Misvalued Codes
3. Consolidating Reviews of Potentially
Misvalued Codes
4. Public Nomination Process
5. CY 2012 Identification and Review of
Potentially Misvalued Services
a. Code Lists
b. Specific Codes
(1) Codes Potentially Requiring Updates to
Direct PE Inputs
(2) Codes Without Direct Practice Expense
Inputs in the Non-Facility Setting
(3) Codes Potentially Requiring Updates to
Physician Work
6. Expanding the Multiple Procedure
Payment Reduction (MPPR) Policy
a. Background
b. CY 2012 Expansion of the MPPR Policy
to the Professional Component of
Advance Imaging Services
c. Further Expansion of MPPR Policies
Under Consideration for Future Years
d. Procedures Subject to the OPPS Cap
C. Overview of the Methodology for
Calculation of Malpractice RVUs
D. Geographic Practice Cost Indices
(GPCIs)
1. Background
2. GPCI Revisions for CY 2012
a. Physician Work GPCIs
b. Practice Expense GPCIs
(1) Affordable Care Act Analysis and
Revisions for PE GPCIs
(A) General Analysis for the CY 2012 PE
GPCIs
(B) Analysis of ACS Rental Data
(C) Employee Wage Analysis
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(D) Purchased Services Analysis
(E) Determining the PE GPCI Cost Share
Weights
(i) Practice Expense
(ii) Employee Compensation
(iii) Office Rent
(iv) Purchased Services
(v) Equipment, Supplies, and Other
Miscellaneous Expenses
(vi) Physician Work and Malpractice GPCIs
(F) PE GPCI Floor for Frontier States
(2) Summary of CY 2012 PE Proposal
c. Malpractice GPCIs
d. Public Comments and CMS Responses
Regarding the CY 2012 Proposed
Revisions to the 6th GPCI Update
e. Summary of CY 2012 Final GPCIs
3. Payment Localities
4. Report From the Institute of Medicine
E. Medicare Telehealth Services for the
Physician Fee Schedule
1. Billing and Payment for Telehealth
Services
a. History
b. Current Telehealth Billing and Payment
Policies
2. Requests for Adding Services to the List
of Medicare Telehealth Services
3. Submitted Requests for Addition to the
List of Telehealth Services for CY 2012
a. Smoking Cessation Services
b. Critical Care Services
c. Domiciliary or Rest Home Evaluation
and Management Services
d. Genetic Counseling Services
e. Online Evaluation and Management
Services
f. Data Collection Services
g. Audiology Services
4. The Process for Adding HCPCS Codes as
Medicare Telehealth Services
5. Telehealth Consultations in Emergency
Departments
6. Telehealth Originating Site Facility Fee
Payment Amount Update
III. Addressing Interim Final Relative
Value Units From CY 2011 and
Establishing Interim Relative Value Units
for CY 2012
A. Methodology
B. Finalizing CY 2011 Interim and
Proposed Values for CY 2012
1. Finalizing CY 2011 Interim and
Proposed Work Values for CY 2012
a. Refinement Panel
(1) Refinement Panel Process
(2) Proposed and Interim Final Work RVUs
Referred to the Refinement Panels in CY
2011
b. Code-Specific Issues
(1) Integumentary System: Skin,
Subcutaneous, and Accessory Structures
(CPT Codes 10140–11047) and Active
Wound Care Management (CPT Codes
97597 and 97598)
(2) Integumentary System: Nails (CPT
Codes 11732–11765)
(3) Integumentary System: Repair (Closure)
(CPT Codes 11900–11901, 12001–12018,
12031–13057, 13100–13101, 15120–
15121, 15260, 15732, 15832))
(4) Integumentary System: Destruction
(CPT Codes 17250–17286)
(5) Integumentary System: Breast (CPT
Codes 19302–19357)
(6) Musculoskeletal: Spine (Vertebral
Column) (CPT Codes 22315–22851)
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(7) Musculoskeletal: Forearm and Wrist
(CPT Codes 25116–25605)
(8) Musculoskeletal: Femur (Thigh Region)
and Knee Joint (CPT Codes 27385–
27530)
(9) Musculoskeletal: Leg (Tibia and Fibula)
and Ankle Joint (CPT Codes 27792)
(10) Musculoskeletal: Foot and Toes (CPT
Codes 28002–28825)
(11) Musculoskeletal: Application of Casts
and Strapping (CPT Codes 29125–29916)
(12) Respiratory: Lungs and Pleura (CPT
Codes 32405–32854)
(13) Cardiovascular: Heart and Pericardium
(CPT Codes 33030–37766)
(14) Digestive: Salivary Glands and Ducts
(CPT Codes 42415–42440)
(15) Digestive: Esophagus (CPT Codes
43262–43415)
(16) Digestive: Rectum (CPT Codes 45331)
(17) Digestive: Biliary Tract (CPT Codes
47480–47564)
(18) Digestive: Abdomen, Peritoneum, and
Omentum (CPT Codes 49082–49655)
(19) Urinary System: Bladder (CPT Codes
51705–53860)
(20) Female Genital System: Vagina (CPT
Codes 57155–57288)
(21) Maternity Care and Delivery (CPT
Codes 59400–59622)
(22) Endocrine System: Thyroid Glad (CPT
Codes 60220–60240)
(23) Endocrine System: Parathyroid,
Thymus, Adrenal Glands, Pancreas, and
Cartoid Body (CPT Codes 60500)
(24) Nervous System: Skull, Meninges,
Brain and Extracranial Peripheral Nerves
and Autonomic Nervous System (CPT
Codes 61781–61885, 64405–64831)
(25) Nervous system: Spine and Spinal
Cord (CPT Codes 62263–63685)
(26) Eye and Ocular Adnexa: Eyeball (CPT
Codes 65285)
(27) Eye and Ocular Adnexa: Posterior
Segment (CPT Codes 67028)
(28) Diagnostic Radiology: Chest, Spine,
and Pelvis (CPT Codes 71250, 72114–
72131)
(29) Diagnostic Radiology: Upper
Extremities (CPT Codes 73080–73700)
(30) Diagnostic Ultrasound: Extremities
(CPT Codes 76881–76882)
(31) Radiation Oncology: Radiation
Treatment Management (CPT Codes
77427–77469)
(32) Nuclear Medicine: Diagnostic (CPT
Codes 78226–78598)
(33) Pathology and Laboratory: Urinalysis
(CPT Codes 88120–88177)
(34) Immunization Administration for
Vaccines/Toxoids (CPT Codes 90460–
90461)
(35) Gastroenterology (CPT Codes 91010–
91117)
(36) Opthalmology: Special
Opthalmological Services (CPT Codes
92081–92285)
(37) Special Otorhinolaryngologic Services
(CPT Codes 92504–92511)
(38) Special Otorhinolaryngologic Services:
Evaluative and Therapeutic Services
(CPT Codes 92605–92618)
(39) Cardiovascular: Therapeutic Services
and Procedures (CPT Codes 92950)
(40) Neurology and Neuromuscular
Procedures: Sleep Testing (CPT Codes
95800–95811)
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(41) Osteopathic Manipulative Treatment
(CPT Codes 98925–98929)
(42) Evaluation and Management: Initial
Observation Care (CPT Codes 99218–
99220)
(43) Evaluation and Management:
Subsequent Observation Care (CPT
Codes 99224–99226)
(44) Evaluation and Management:
Subsequent Hospital Care (CPT Codes
99234–99236)
2. Finalizing CY 2011 Interim Direct PE
RVUs for CY 2012
a. Background and Methodology
b. Common Refinements
(1) General Equipment Time
(2) Supply and Equipment Items Missing
Invoices
c. Code-Specific Direct PE Inputs
(1) CT Abdomen and Pelvis
(2) Endovascular Revascularization
(3) Nasal/Sinus Endoscopy
(4) Insertion of Intraperitoneal Catheter
(5) In Situ Hybridization Testing
(6) External Mobile Cardivascular
Telemetry
3. Finalizing CY 2011 Interim Final and CY
2012 Proposed Malpractice RVUs
a. Finalizing CY 2011 Interim Final
Malpractice RVUs
b. Finalizing CY 2012 Proposed
Malpractice RVUs, Including
Malpractice RVUs for Certain
Cardiothoracic Surgery Services
4. Payment for Bone Density Tests
5. Other New, Revised, or Potentially
Misvalued Codes With CY 2011 Interim
Final RVUs or CY 2012 Proposed RVUs
Not Specifically Discussed in the CY
2012 Final Rule With Comment Period
C. Establishing Interim Final RVUs for CY
2012
1. Establishing Interim Final Work RVUs
for CY 2012
a. Code-Specific Issues
(1) Integumentary System: Skin,
Subcutaneous, and Accessory Structures
(CPT Codes 10060–10061, 11056)
(2) Integumentary System: Nails (CPT
Codes 11719–11721, and G0127)
(3) Integumentary System: Repair (Closure)
(CPT Codes 15271–15278, 16020, 16025)
(4) Musculoskeletal: Hand and Fingers
(CPT Codes 26341)
(5) Musculoskeletal: Application of Casts
and Strapping (CPT Codes 29125–29881)
(6) Musculoskeletal: Endoscopy/
Arthroscopy (CPT codes 29826, 29880,
29881)
(7) Respiratory: Lungs and Pleura (CPT
Codes 32096–32674)
(8) Cardiovascular: Heart and Pericardium
(CPT Codes 33212–37619)
(A) Pediatric Cardiovascular Code (CPT
Code 36000)
(B) Renal Angiography codes (CPT Codes
36251–36254)
(C) IVC Transcatheter Procedures (CPT
Codes 37191–37193)
(9) Hemic and Lymphatic: General (CPT
Codes 38230–38232)
(10) Digestive: Liver (CPT Codes 47000)
(11) Digestive: Abdomen, Peritoneum, and
Omentum (CPT Codes 49082–49084)
(12) Nervous system: Spine and Spinal
Cord (CPT Codes 62263–63685)
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(13) Nervous System: Extracranial Nerves,
Peripheral Nerves, and Autonomic
Nervous System (CPT Codes 64633–
64636)
(14) Diagnostic Radiology: Abdomen (CPT
Codes 74174–74178)
(15) Pathology and Laboratory:
Cytopathology (CPT Codes 88101–88108)
(16) Psychiatry: Psychiatric Therapeutic
Procedures (CPT Codes 90854, 90867–
98069)
(17) Opthalmology: Special
Opthalmological Services (CPT Codes
92071–92072)
(18) Special Otorhinolaryngologic Services:
Audologic Function Tests (CPT Codes
92558–92588)
(19) Special Otorhinolaryngologic Services:
Evaluative and Therapeutic Services
(CPT Codes 92605 and 92618)
(20) Cardiovascular: Cardiac
Catheterization (CPT Codes 93451–
93568)
(21) Pulmonary: Other Procedures (CPT
Codes 94060–94781)
(22) Neurology and Neuromuscular
Procedures: Nerve Conduction Tests
(CPT Codes 95885–95887)
(23) Neurology and Neuromuscular
Procedures: Autonomic Function Tests
(CPT Codes 95938–95939)
(24) Other CY 2012 New, Revised, and
Potentially Misvalued CPT Codes Not
Specifically Discussed Previously
2. Establishing Interim Final Direct PE
RVUs for CY 2012
3. Establishing Interim Final Malpractice
RVUs for CY 2012
IV. Allowed Expenditures for Physicians’
Services and the Sustainable Growth
Rate
A. Medicare Sustainable Growth Rate
(SGR)
1. Physicians’ Services
2. Preliminary Estimate of the SGR for 2012
3. Revised Sustainable Growth Rate for CY
2011
4. Final Sustainable Growth Rate for CY
2010
5. Calculation of CYs 2012, 2011, and 2010
Sustainable Growth Rates
a. Detail on the CY 2012 SGR
(1) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2012
(2) Factor 2—The Percentage Change in the
Average Number of Part B Enrollees
From CY 2011 to CY 2012
(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
2012
(4) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2012 Compared With
CY 2011
b. Detail on the CY 2011 SGR
(1) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2011
(2) Factor 2—The Percentage Change in the
Average Number of Part B Enrollees
From CY 2010 to CY 2011
(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
CY 2011
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(4) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2011 Compared With
CY 2010
c. Detail on the CY 2010 SGR
(1) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2010
(2) Factor 2—The Percentage Change in the
Average Number of Part B Enrollees
From CY 2009 to CY 2010
(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
CY 2010
(4) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2010 Compared With
CY 2009
B. The Update Adjustment Factor (UAF)
1. Calculation Under Current Law
C. The Percentage Change in the Medicare
Economic Index (MEI)
D. Physician and Anesthesia Fee Schedule
Conversion Factors for CY 2012
1. Physician Fee Schedule Update and
Conversion Factor
a. CY 2012 PFS Update
b. CY 2011 PFS Conversion Factor
2. Anesthesia Conversion Factor
V. Other PFS Issues
A. Section 105: Extension of Payment for
Technical Component of Certain
Physician Pathology Services
B. Bundling of Payments for Services
Provided to Outpatients Who Later Are
Admitted as Inpatients: 3-Day Payment
Window Policy and the Impact on
Wholly Owned or Wholly Operated
Physician Practices
1. Introduction
2. Background
3. Applicability of the 3-Day Payment
Window Policy for Services Furnished in
Physician Practices
a. Payment Methodology
b. Identification of Wholly Owned or
Wholly Operated Physician Practices
C. Medicare Therapy Caps
VI. Other Provisions of the Final Rule
A. Part B Drug Payment: Average Sales
Price (ASP) Issues
1. Widely Available Market Price (WAMP)/
Average Manufacturer Price
2. AMP Threshold and Price Substitutions
a. AMP Threshold
b. AMP Price Substitution
(1) Inspector General Studies
(2) Proposal
(3) Timeframe for and Duration of Price
Substitutions
(4) Implementation of AMP-Based Price
Substitution and the Relationship of ASP
to AMP
3. ASP Reporting Update
a. ASP Reporting Template Update
b. Reporting of ASP Units and Sales
Volume for Certain Products
4. Out of Scope Comments
B. Discussion of Budget Neutrality for the
Chiropractic Services Demonstration
C. Productivity Adjustment for the
Ambulatory Surgical Center Payment
System, and the Ambulance, Clinical
Laboratory and DMEPOS Fee Schedules
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D. Clinical Laboratory Fee schedule:
Signature on Requisition
1. History and Overview
2. Proposed Changes
E. Section 4103 of the Affordable Care Act:
Medicare Coverage and Payment of the
Annual Wellness Visit Providing a
Personalized Prevention Plan Under
Medicare Part B
1. Incorporation of a Health Risk
Assessment as Part of the Annual
Wellness Visit
a. Background and Statutory Authority—
Medicare Part B Coverage of an Annual
Wellness Visit Providing Personalized
Prevention Plan Services
b. Implementation
(1) Definition of a ‘‘Health Risk
Assessment’’
(2) Changes to the Definitions of First
Annual Wellness Visit and Subsequent
Annual Visit
(3) Additional Comments
(4) Summary
2. The Addition of a Health Risk
Assessment as a Required Element for
the Annual Wellness Visit Beginning in
2012
a. Payment for AWV Services With the
Inclusion of an HRA Element
F. Quality Reporting Initiatives
1. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
a. Program Background and Statutory
Authority
b. Methods of Participation
(1) Individual Eligible Professionals
(2) Group Practices
(A) Background and Authority
(B) Definition of Group Practice
(C) Process for Physician Group Practices
To Participate as Group Practices
c. Reporting Period
d. Reporting Mechanisms—Individual
Eligible Professionals
(1) Claims-Based Reporting
(2) Registry-Based Reporting
(A) Requirements for the Registry-Based
Reporting Mechanism—Individual
Eligible Professionals
(B) 2012 Qualification Requirements for
Registries
(3) EHR-Based Reporting
(A) Direct EHR-Based Reporting
(i) Requirements for the Direct EHR-Based
Reporting Mechanism—Individual
Eligible Professionals
(ii) 2012 Qualification Requirements for
Direct EHR-Based Reporting Products
(B) EHR Data Submission Vendors
(i) Requirements for EHR Data Submission
Vendors Based on Reporting
Mechanism—Individual Eligible
Professionals
(ii) 2012 Qualification Requirements for
EHR Data Submission Vendors
(C) Qualification Requirements for Direct
EHR-Based Reporting Data Submission
Vendors and Their Products for the 2013
Physician Quality Reporting System
e. Incentive Payments for the 2012
Physician Quality Reporting System
(1) Criteria for Satisfactory Reporting of
Individual Quality Measures for
Individual Eligible Professionals via
Claims
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(2) 2012 Criteria for Satisfactory Reporting
of Individual Quality Measures for
Individual Eligible Professionals via
Registry
(3) Criteria for Satisfactory Reporting of
Individual Quality Measures for
Individual Eligible Professionals via EHR
(4) Criteria for Satisfactory Reporting of
Measures Groups via Claims—Individual
Eligible Professionals
(5) 2012 Criteria for Satisfactory Reporting
of Measures Groups via Registry—
Individual Eligible Professionals
(6) 2012 Criteria for Satisfactory Reporting
on Physician Quality Reporting System
Measures by Group Practices Under the
GPRO
f. 2012 Physician Quality Reporting System
Measures
(1) Statutory Requirements for the
Selection of 2012 Physician Quality
Reporting System Measures
(2) Other Considerations for the Selection
of 2012 Physician Quality Reporting
System Measures
(3) 2012 Physician Quality Reporting
System Individual Measures
(A) 2012 Physician Quality Reporting
System Core Measures Available for
Claims, Registry, and/or EHR-Based
Reporting
(B) 2012 Physician Quality Reporting
System Individual Measures for Claims
and Registry Reporting
(C) 2012 Measures Available for EHRBased Reporting
(4) 2012 Physician Quality Reporting
System Measures Groups
(5) 2012 Physician Quality Reporting
System Quality Measures for Group
Practices Selected To Participate in the
GPRO (GPRO)
g. Maintenance of Certification Program
Incentive
h. Feedback Reports
i. Informal Review
j. Future Payment Adjustments for the
Physician Quality Reporting System
2. Incentives and Payment Adjustments for
Electronic Prescribing (eRx)—The
Electronic Prescribing Incentive Program
a. Program Background and Statutory
Authority
b. Eligibility
(1) Individual Eligible Professionals
(A) Definition of Eligible Professional
(2) Group Practices
(A) Definition of ‘‘Group Practice’’
(B) Process To Participate in the eRx
Incentive Program—eRx GPRO
c. Reporting Periods
(1) Reporting Periods for the 2012 and 2013
eRx Incentives
(2) Reporting Periods for the 2013 and 2014
eRx Payment Adjustments
d. Standard for Determining Successful
Electronic Prescribers
(1) Reporting the Electronic Prescribing
Quality Measure
(2) The Denominator for the Electronic
Prescribing Measure
(3) The Reporting Numerator for the
Electronic Prescribing Measure
e. Required Functionalities and Part D
Electronic Prescribing Standards
(1) ‘‘Qualified’’ Electronic Prescribing
System
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(2) Part D Electronic Prescribing Standards
f. Reporting Mechanisms for the 2012 and
2013 Reporting Periods
(1) Claims-Based Reporting
(2) Registry-Based Reporting
(3) EHR-Based Reporting
g. The 2012 and 2013 eRx Incentives
(1) Applicability of 2012 and 2013 eRx
Incentives for Eligible Professionals and
Group Practices
(2) Reporting Criteria for Being a
Successful Electronic for the 2012 and
2013 eRx Incentives—Individual Eligible
Professionals
(3) Criteria for Being a Successful
Electronic Prescriber 2012 and 2013 eRx
Incentives—Group Practices
(4) No Double Payments
h. The 2013 and 2014 Electronic
Prescribing Payment Adjustments
(1) Limitations to the 2013 and 2014 eRx
Payment Adjustments—Individual
Eligible Professionals
(2) Requirements for the 2013 and 2014
eRx Payment Adjustments—Individual
Eligible Professionals
(3) Requirements for the 2013 and 2014
eRx Payment Adjustments—Group
Practices
(4) Significant Hardship Exemptions
(A) Significant Hardship Exemptions
(i) Inability To Electronically Prescribe Due
to Local, State, or Federal Law or
Regulation
(ii) Eligible Professionals Who Prescribe
Fewer Than 100 Prescriptions During a
6-Month, Payment Adjustment Reporting
Period
(B) Process for Submitting Significant
Hardship Exemptions—Individual
Eligible Professionals and Group
Practices
G. Physician Compare Web site
1. Background and Statutory Authority
2. Final Plans
H. Medicare EHR Incentive Program for
Eligible Professionals for the 2012
Payment Year
1. Background
2. Attestation
3 The Physician Quality Reporting
System—Medicare EHR Incentive Pilot
a. EHR Data Submission Vendor-Based
Reporting Option
b. Direct EHR-Based Reporting Option
4. Method for EPs To Indicate Election To
Participate in the Physician Quality
Reporting System—Medicare EHR
Incentive Pilot for Payment Year 2012
I. Establishment of the Value-Based
Payment Modifier and Improvements to
the Physician Feedback Program
1. Overview
2. The Value Based Modifier
a. Measures of Quality of Care and Costs
(1) Quality of Care Measures
(A) Quality of Care Measures for the ValueModifier
(B) Potential Quality of Care Measures for
Additional Dimensions of Care in the
Value Modifier
(i) Outcome Measures
(ii) Care Coordination/Transition Measures
(iii) Patient Safety, Patient Experience and
Functional Status
(2) Cost Measures
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(A) Cost Measures for the Value Modifier
(B) Potential Cost Measures for Future Use
in the Value Modifier
b. Implementation of the Value Modifier
c. Initial Performance Period
d. Other Issues
3. Physician Feedback Program
a. Alignment of Physician Quality
Reporting System Quality Care Measures
With the Physician Feedback Reports
b. 2010 Physician Group and Individual
Reports Disseminated in 2011
J. Physician Self-Referral Prohibition:
Annual Update to the List of CPT/
HCPCS Codes
1. General
2. Annual Update to the Code List
a. Background
b. Response to Comments
c. Revisions Effective for 2012
K. Technical Corrections
1. Outpatient Speech-Language Pathology
Services: Conditions and Exclusions
2. Outpatient Diabetes Self-Management
Training and Diabetes Outcome
Measurements
a. Changes to the Definition of Deemed
Entity
b. Changes to the Condition of Coverage
Regarding Training Orders
3. Practice Expense Relative Value Units
(RVUs)
VII. Waiver of Proposed Rulemaking and
Collection of Information Requirements
A. Waiver of Proposed Rulemaking and
Delay of Effective Date
B. Collection of Information Requirements
1. Part B Drug Payment
2. The Physician Quality Reporting System
(Formerly the Physician Quality
Reporting Initiative (PQRI))
a. Estimated Participation in the 2010
Physician Quality Reporting System
b. Burden Estimate on Participation in the
2010 Physician Quality Reporting
System—Individual Eligible
Professionals
(1) Burden Estimate on Participation in the
2012 Physician Quality Report System
via the Claims-Based Reporting
Mechanism—Individual Eligible
Professionals
(2) Burden Estimate on Participation in the
2012 Physician Quality Reporting
System—Group Practices
(3) Burden Estimate on Participation in the
Maintenance of Certification Program
Incentive
(4) Burden Estimate on Participation in the
Maintenance of Certification Program
Incentive
3. Electronic Prescribing (eRx) Incentive
Program
a. Estimate on Participation in the 2012,
2013, and 2014 eRx Incentive Program
b. Burden Estimate on Participation in the
eRx Incentive Program—Individual
Eligible Professionals
(1) Burden Estimate on Participation in the
eRx Incentive Program via the ClaimsBased Reporting Mechanism– Individual
Eligible Professionals
(2) Burden Estimate on Participation in the
eRx Incentive Program via the RegistryBased Reporting Mechanism– Individual
Eligible Professionals and Group
Practices
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(3) Burden Estimate on Participation in the
eRx Incentive Program via the EHRBased Reporting Mechanism—Individual
Eligible Professionals and Group
Practices
(4) Burden Estimate on Participation in the
eRx Incentive Program—Group Practices
4. Medicare Electronic Health Record
(EHR) Incentive Program for Eligible
Professionals for the 2012 Payment Year
VIII. Response to Comments
IX. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. RVU Impacts
1. Resource-Based Work, PE, and
Malpractice RVUs
2. CY 2012 PFS Impact Discussion
a. Changes in RVUs
b. Combined Impact
D. Effects of Proposal To Review
Potentially Misvalued Codes on an
Annual Basis Under the PFS
E. Effect of Revisions to Malpractice RUVs
F. Effect of Changes to Geographic Practice
Cost Indices (GPCIs)
G. Effects of Final Changes to Medicare
Telehealth Services Under the Physician
Fee Schedule H Effects of the Impacts of
Other Provisions of the Final Rule With
Comment Period
1. Part B Drug Payment: ASP Issues
2. Chiropractic Services Demonstration
3. Extension of Payment for Technical
Component of Certain Physician
Pathology Services
4. Section 4103: Medicare Coverage of
Annual Wellness Visit Providing a
Personalized Prevention Plan:
Incorporation of a Health Risk
Assessment as Part of the Annual
Wellness Visit
5. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
6. Incentives for Electronic Prescribing
(eRx)—The Electronic Prescribing
Incentive Program
7. Physician Compare Web site
8. Medicare EHR Incentive Program
9. Physician Feedback Program/Value
Modifier Payment
10. Bundling of Payments for Services
Provided to Outpatients Who Later Are
Admitted as Inpatients: 3-Day Window
Policy and Impact on Wholly Owned or
Wholly Operated Physician Offices
11. Clinical Lab Fee Schedule: Signature
on Requisition
I. Alternatives Considered
J. Impact on Beneficiaries
K. Accounting Statement
L. Conclusion
X. Addenda Referenced in This Rule and
Available Only Through the Internet on
the CMS Web Site
Regulations Text
Acronyms
In addition, because of the many
organizations and terms to which we
refer by acronym in this final rule with
comment period, we are listing these
acronyms and their corresponding terms
in alphabetical order as follows:
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AA Anesthesiologist assistant
AACE American Association of Clinical
Endocrinologists
AACVPR American Association of
Cardiovascular and Pulmonary
Rehabilitation
AADE American Association of Diabetes
Educators
AANA American Association of Nurse
Anesthetists
ABMS American Board of Medical
Specialties
ABN Advanced Beneficiary Notice
ACC American College of Cardiology
ACGME Accreditation Council on Graduate
Medical Education
ACLS Advanced cardiac life support
ACP American College of Physicians
ACR American College of Radiology
ACS American Community Survey
ADL Activities of daily living
AED Automated external defibrillator
AFROC Association of Freestanding
Radiation Oncology Centers
AFS Ambulance Fee Schedule
AHA American Heart Association
AHFS–DI American Hospital Formulary
Service-Drug Information
AHRQ [HHS] Agency for Healthcare
Research and Quality
AMA American Medical Association
AMA RUC [AMA’s Specialty Society]
Relative (Value) Update Committee
AMA–DE American Medical Association
Drug Evaluations
AMI Acute Myocardial Infarction
AMP Average Manufacturer Price
AO Accreditation organization
AOA American Osteopathic Association
APA American Psychological Association
APC Administrative Procedures Act
APTA American Physical Therapy
Association
ARRA American Recovery and
Reinvestment Act (Pub. L. 111–5)
ASC Ambulatory surgical center
ASP Average Sales Price
ASPE Assistant Secretary of Planning and
Evaluation (ASPE)
ASRT American Society of Radiologic
Technologists
ASTRO American Society for Therapeutic
Radiology and Oncology
ATA American Telemedicine Association
AWP Average Wholesale Price
AWV Annual Wellness Visit
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)
BIPA Medicare, Medicaid, and SCHIP
Benefits Improvement Protection Act of
2000 (Pub. L. 106–554)
BLS Bureau of Labor and Statistics
BMD Bone Mineral Density
BMI Body Mass Index
BN Budget Neutrality
BPM Benefit Policy Manual
CABG Coronary Artery Bypass Graft
CAD Coronary Artery Disease
CAH Critical Access Hospital
CAHEA Committee on Allied Health
Education and Accreditation
CAP Competitive Acquisition Program
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CARE Continuity Assessment Record and
Evaluation
CBIC Competitive Bidding Implementation
Contractor
CBP Competitive Bidding Program
CBSA Core-Based Statistical Area
CDC Centers for Disease Control and
Prevention
CEM Cardiac Event Monitoring
CF Conversion Factor
CFC Conditions for Coverage
CFR Code of Federal Regulations
CKD Chronic Kidney Disease
CLFS Clinical Laboratory Fee Schedule
CMA California Medical Association
CMD Contractor Medical Director
CME Continuing Medical Education
CMHC Community Mental Health Center
CMPs Civil Money Penalties
CMS Centers for Medicare & Medicaid
Services
CNS Clinical Nurse Specialist
CoP Condition of Participation
COPD Chronic Obstructive Pulmonary
Disease
CORF Comprehensive Outpatient
Rehabilitation Facility
COS Cost of Service
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPI–U Consumer Price Index for Urban
Consumers
CPR Cardiopulmonary Resuscitation
CPT [Physicians] Current Procedural
Terminology (4th Edition, 2002,
copyrighted by the American Medical
Association)
CQM Clinical Quality Measures
CR Cardiac Rehabilitation
CRF Chronic Renal Failure
CRNA Certified Registered Nurse
Anesthetist
CROs Clinical Research Organizations
CRP Canalith Repositioning
CRT Certified Respiratory Therapist
CSC Computer Sciences Corporation
CSW Clinical Social Worker
CT Computed Tomography
CTA Computed Tomography Angiography
CWF Common Working File
CY Calendar Year
D.O. Doctor of Osteopathy
DEA Drug Enforcement Agency
DHHS Department of Health and Human
Services
DHS Designated health services
DME Durable Medical Equipment
DMEPOS Durable medical equipment,
prosthetics, orthotics, and supplies
DOJ Department of Justice
DOQ Doctors Office Quality
DOS Date of service
DOTPA Development of Outpatient
Therapy Alternatives
DRA Deficit Reduction Act of 2005 (Pub. L.
109–171)
DSMT Diabetes Self-Management Training
Services
DXA CPT Dual energy X-ray absorptiometry
E/M Evaluation and Management Medicare
Services
ECG Electrocardiogram
EDI Electronic data interchange
EEG Electroencephalogram
EGC Electrocardiogram
EHR Electronic health record
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EKG Electrocardiogram
EMG Electromyogram
EMTALA Emergency Medical Treatment
and Active Labor Act
EOG Electro-oculogram
EPO Erythopoeitin
EPs Eligible Professional
eRx Electronic Prescribing
ESO Endoscopy Supplies
ESRD End-Stage Renal Disease
FAA Federal Aviation Administration
FAX Facsimile
FDA Food and Drug Administration (HHS)
FFS Fee-for-service
FISH In Situ Hybridization Testing
FOTO Focus On Therapeutic Outcomes
FQHC Federally Qualified Health Center
FR Federal Register
FTE Full Time Equivalent
GAF Geographic Adjustment Factor
GAO Government Accountability Office
GEM Generating Medicare [Physician
Quality Performance Measurement Results]
GFR Glomerular Filtration Rate
GME Graduate Medical Education
GPCIs Geographic Practice Cost Indices
GPO Group Purchasing Organization
GPRO Group Practice Reporting Option
GPS Geographic Positioning System
GSA General Services Administration
GT Growth Target
HAC Hospital-Acquired Conditions
HBAI Health and Behavior Assessment and
Intervention
HCC Hierarchal Condition Category
HCPAC Health Care Professionals Advisory
Committee
HCPCS Healthcare Common Procedure
Coding System
HCRIS Healthcare Cost Report Information
System
HDL/LDL High-Density Lipoprotein/LowDensity Lipoprotein
HDRT High Dose Radiation Therapy
HEMS Helicopter Emergency Medical
Services
HH PPS Home Health Prospective Payment
System
HHA Home Health Agency
HHRG Home Health Resource Group
HHS [Department of] Health and Human
Services
HIPAA Health Insurance Portability and
Accountability Act of 1996 (Pub. L. 104–
191)
HIT Health Information Technology
HITECH Health Information Technology for
Economic and Clinical Health Act (Title IV
of Division B of the Recovery Act, together
with Title XIII of Division A of the
Recovery Act)
HITSP Healthcare Information Technology
Standards Panel
HIV Human Immunodeficiency Virus
HMO Health Maintenance Organization
HOPD Hospital Outpatient Department
HPSA Health Professional Shortage Area
HRA Health Risk Assessment
HRSA Health Resources Services
Administration (HHS)
HSIP HPSA Surgical Incentive Program
HUD Department of Housing and Urban
Development
HUD Housing and Urban Development
IACS Individuals Access to CMS Systems
IADL Instrumental Activities of Daily
Living
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ICD International Classification of Diseases
ICF Intermediate Care Facilities
ICF International Classification of
Functioning, Disability and Health
ICR Intensive Cardiac Rehabilitation
ICR Information Collection Requirement
IDE Investigational Device Exemption
IDTF Independent Diagnostic Testing
Facility
IFC Interim Rinal Rule with Comment
Period
IGI IHS Global Insight, Inc.
IME Indirect Medical Education
IMRT Intensity-Modulated Radiation
Therapy
INR International Normalized Ratio
IOM Institute of Medicine
IOM Internet Only Manual
IPCI Indirect Practice Cost Index
IPPE Initial Preventive Physical
Examination
IPPS Inpatient Prospective Payment System
IRS Internal Revenue Service
ISO Insurance Services Office
IVD Ischemic Vascular Disease
IVIG Intravenous Immune Globulin
IWPUT Intra-service Work Per Unit of Time
JRCERT Joint Review Committee on
Education in Radiologic Technology
KDE Kidney Disease Education
LCD Local Coverage Determination
LOPS Loss of Protective Sensation
LUGPA Large Urology Group Practice
Association
M.D. Doctor of Medicine
MA Medicare Advantage Program
MAC Medicare Administrative Contractor
MA–PD Medicare Advantage-Prescription
Drug Plans
MAV Measure Applicability Validation
MCMP Medicare Care Management
Performance
MCP Monthly Capitation Payment
MDRD Modification of Diet in Renal
Disease
MedCAC Medicare Evidence Development
and Coverage Advisory Committee
(formerly the Medicare Coverage Advisory
Committee (MCAC))
MedPAC Medicare Payment Advisory
Commission
MEI Medicare Economic Index
MGMA Medical Group Management
Association
MIEA–TRHCA Medicare Improvements and
Extension Act of 2006 (that is, Division B
of the Tax Relief and Health Care Act of
2006 (TRHCA) (Pub. L. 109–432)
MIPPA Medicare Improvements for Patients
and Providers Act of 2008 (Pub. L. 110–
275)
MMA Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173)
MMEA Medicare and Medicaid Extenders
Act of 2010 (Pub. L. 111–309)
MMSEA Medicare, Medicaid, and SCHIP
Extension Act of 2007 (Pub. L. 110–173)
MNT Medical Nutrition Therapy
MOC Maintenance of Certification
MP Malpractice
MPC Multispecialty Points of Comparison
MPPR Multiple Procedure Payment
Reduction Policy
MQSA Mammography Quality Standards
Act of 1992 (Pub. L. 102–539)
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MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MSA Metropolitan Statistical Area
MSP Medicare Secondary Payer
MUE Medically Unlikely Edit
NAICS North American Industry
Classification System
NBRC National Board for Respiratory Care
NCCI National Correct Coding Initiative
NCD National Coverage Determination
NCQA National Committee for Quality
Assurance
NCQDIS National Coalition of Quality
Diagnostic Imaging Services
NDC National Drug Codes
NF Nursing facility
NISTA National Institute of Standards and
Technology Act
NP Nurse Practitioner
NPI National Provider Identifier
NPP Nonphysician Practitioner
NPPES National Plan & Provider
Enumeration System
NQF National Quality Forum
NRC Nuclear Regulatory Commission
NSQIP National Surgical Quality
Improvement Program
NTSB National Transportation Safety Board
NUBC National Uniform Billing Committee
OACT [CMS] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
OCR Optical Character Recognition
ODF Open Door Forum
OES Occupational Employment Statistics
OGPE Oxygen Generating Portable
Equipment
OIG Office of the Inspector General
OMB Office of Management and Budget
ONC [HHS] Office of the National
Coordinator for Health IT
OPPS Outpatient Prospective Payment
System
OSCAR Online Survey and Certification
and Reporting
PA Physician Assistant
PACE Program of All-inclusive Care for the
Elderly
PACMBPRA Preservation of Access to Care
for Medicare Beneficiaries and Pension
Relief Act of 2010 (Pub. L. 111–192)
PAT Performance Assessment Tool
PC Professional Components
PCI Percutaneous Coronary Intervention
PCIP Primary Care Incentive Payment
Program
PDP Prescription Drug Plan
PE Practice Expense
PE/HR Practice Expense per Hour
PEAC Practice Expense Advisory
Committee
PECOS Provider Enrollment Chain and
Ownership System
PERC Practice Expense Review Committee
PFS Physician Fee Schedule
PGP [Medicare] Physician Group Practice
PHI Protected Health Information
PHP Partial Hospitalization Program
PIM [Medicare] Program Integrity Manual
PLI Professional Liability Insurance
POA Present On Admission
POC Plan Of Care
PODs Physician Owned Distributors
PPATRA Physician Payment And Therapy
Relief Act
PPI Producer Price Index
PPIS Physician Practice Expense
Information Survey
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PPPS Personalized Prevention Plan
Services
PPS Prospective Payment System
PPTA Plasma Protein Therapeutics
Association
PQRI Physician Quality Reporting Initiative
PR Pulmonary rehabilitation
PRA Paperwork Reduction Act
PSA Physician Scarcity Areas
PT Physical Therapy
PTA Physical Therapy Assistant
PTCA Percutaneous Transluminal Coronary
Angioplasty
PVBP Physician and Other Health
Professional Value-Based Purchasing
Workgroup
QDCs (Physician Quality Reporting System)
Quality Data Codes
RA Radiology Assistant
RAC Medicare Recovery Audit Contractor
RBMA Radiology Business Management
Association
RFA Regulatory Flexibility Act
RHC Rural Health Clinic
RHQDAPU Reporting Hospital Quality Data
Annual Payment Update Program
RIA Regulatory Impact Analysis
RN Registered Nurse
RNAC Reasonable Net Acquisition Cost
RPA Radiology Practitioner Assistant
RRT Registered Respiratory Therapist
RUC [AMA’s Specialty Society] Relative
(Value) Update Committee
RVRBS Resource-Based Relative Value
Scale
RVU Relative Value Unit
SBA Small Business Administration
SCHIP State Children’s Health Insurance
Programs
SDW Special Disability Workload
SGR Sustainable Growth Rate
SLP Speech-Language Pathology
SMS [AMAs] Socioeconomic Monitoring
System
SNF Skilled Nursing Facility
SOR System of Record
SRS Stereotactic Radiosurgery
SSA Social Security Administration
SSI Social Security Income
STARS Services Tracking and Reporting
System
STATS Short Term Alternatives for
Therapy Services
STS Society for Thoracic Surgeons
TC Technical Components
TIN Tax Identification Number
TJC Joint Commission
TRHCA Tax Relief and Health Care Act of
2006 (Pub. L. 109–432)
TTO Transtracheal Oxygen
UAF Update Adjustment Factor
UPMC University of Pittsburgh Medical
Center
URAC Utilization Review Accreditation
Committee
USDE United States Department of
Education
USP–DI United States Pharmacopoeia-Drug
Information
VA Department of Veterans Affairs
VBP Value-Based Purchasing
WAC Wholesale Acquisition Cost
WAMP Widely Available Market Price
WHO World Health Organization
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Addenda Available Only Through the
Internet on the CMS Web Site
In the past, the Addenda referred to
throughout the preamble of our annual
PFS proposed and final rules with
comment period were included in the
printed Federal Register. However,
beginning with the CY 2012 PFS
proposed rule, the PFS Addenda no
longer appear in the Federal Register.
Instead these Addenda to the annual
proposed and final rules with comment
period will be available only through
the Internet. The PFS Addenda along
with other supporting documents and
tables referenced in this final rule with
comment period are available through
the Internet on the CMS Web site at
https://www.cms.gov/
PhysicianFeeSched/. 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 2012 PFS final rule with
comment period, refer to item CMS–
1524–FC. For complete details on the
availability of the Addenda referenced
in this final rule with comment period,
we refer readers to section X. of this
final rule with comment period. Readers
who experience any problems accessing
any of the Addenda or other documents
referenced in this final rule with
comment period and posted on the CMS
Web site identified above should
contact Rebecca Cole at (410) 786–1589
or Erin Smith at (410) 786–4497.
CPT (Current Procedural Terminology)
Copyright Notice
Throughout this final rule with
comment period, we use CPT codes and
descriptions to refer to a variety of
services. We note that CPT codes and
descriptions are copyright 2010
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.
emcdonald on DSK4SPTVN1PROD with RULES2
I. Background
Since January 1, 1992, Medicare has
paid for physicians’ services under
section 1848 of the Social Security Act
(the Act), ‘‘Payment for Physicians’
Services.’’ The Act requires that
payments under the physician fee
schedule (PFS) are based on national
uniform relative value units (RVUs)
based on the relative resources used in
furnishing a service. Section 1848(c) of
the Act requires that national RVUs be
established for physician work, practice
expense (PE), and malpractice expense.
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Before the establishment of the
resource-based relative value system,
Medicare payment for physicians’
services was based on reasonable
charges. We note that throughout this
final rule with comment period, unless
otherwise noted, the term ‘‘practitioner’’
is used to describe both physicians and
nonphysician practitioners (such as
physician assistants, nurse practitioners,
clinical nurse specialists, certified
nurse-midwives, psychologists, or
clinical social workers) that are
permitted to furnish and bill Medicare
under the PFS for their services.
A. Development of the Relative Value
System
1. Work RVUs
The concepts and methodology
underlying the PFS were enacted as part
of the Omnibus Budget Reconciliation
Act (OBRA) of 1989 (Pub. L. 101–239),
and OBRA 1990, (Pub. L. 101–508). The
final rule, published on November 25,
1991 (56 FR 59502), set forth the fee
schedule for payment for physicians’
services beginning January 1, 1992.
Initially, only the physician work RVUs
were resource-based, and the PE and
malpractice RVUs were based on
average allowable charges.
The physician work RVUs established
for the implementation of the fee
schedule in January 1992 was
developed with extensive input from
the physician community. A research
team at the Harvard School of Public
Health developed the original physician
work RVUs for most codes in a
cooperative agreement with the
Department of Health and Human
Services (DHHS). In constructing the
code-specific vignettes for 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.
Section 1848(b)(2)(B) of the Act
specifies that the RVUs for anesthesia
services are based on RVUs from a
uniform relative value guide, with
appropriate adjustment of the
conversion factor (CF), in a manner to
assure that fee schedule amounts for
anesthesia services are consistent with
those for other services of comparable
value. We established a separate CF for
anesthesia services, and we continue to
utilize time units as a factor in
determining payment for these services.
As a result, there is a separate payment
methodology for anesthesia services.
We establish physician work RVUs for
new and revised codes based, in part, on
our review of recommendations
received from the American Medical
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Association’s (AMA’s) Specialty Society
Relative Value Update Committee
(RUC).
2. Practice Expense Relative Value Units
(PE RVUs)
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 to consider
general categories of expenses (such as
office rent and wages of personnel, but
excluding malpractice expenses)
comprising PEs.
Section 4505(a) of the Balanced
Budget Act of 1997 (BBA) (Pub. L. 105–
33), amended section 1848(c)(2)(C)(ii) of
the Act to delay 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 charge-based PE
RVUs to resource-based RVUs.
We established the resource-based PE
RVUs for each physician’s service in a
final rule with comment period,
published November 2, 1998 (63 FR
58814), effective for services furnished
in 1999. Based on the requirement to
transition to a resource-based system for
PE over a 4-year period, resource-based
PE RVUs did not become fully effective
until 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. The CPEP data were
collected from panels of physicians,
practice administrators, and
nonphysician health professionals (for
example, registered nurses (RNs))
nominated by physician specialty
societies and other groups. The CPEP
panels identified the direct inputs
required for each physician’s service in
both the office setting and out-of-office
setting. We have since refined and
revised these inputs based on
recommendations from the AMA RUC.
The AMA’s SMS data provided
aggregate specialty-specific information
on hours worked and PEs.
Separate PE RVUs are established for
procedures that can be performed in
both a nonfacility setting, such as a
physician’s office, and a facility setting,
such as a hospital outpatient
department (HOPD). The difference
between the facility and nonfacility
RVUs reflects the fact that a facility
typically receives separate payment
from Medicare for its costs of providing
the service, apart from payment under
the PFS. The nonfacility RVUs reflect all
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of the direct and indirect PEs of
providing a particular service.
Section 212 of the Balanced Budget
Refinement Act of 1999 (BBRA) (Pub. L.
106–113) 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 with
comment period 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 calendar year (CY) 2007 PFS
final rule with comment period (71 FR
69624), we revised the methodology for
calculating direct PE RVUs from the topdown to the bottom-up methodology
beginning in CY 2007 and provided for
a 4-year transition for the new PE RVUs
under this new methodology. This
transition ended in CY 2010 and direct
PE RVUs are calculated in CY 2012
using this methodology, unless
otherwise noted.
In the CY 2010 PFS final rule with
comment period (74 FR 61749), we
updated the PE/hour (PE/HR) data that
are used in the calculation of PE RVUs
for most specialties. For this update, we
used the Physician Practice Information
Survey (PPIS) conducted by the AMA.
The PPIS is a multispecialty, nationally
representative, PE survey of both
physicians and nonphysician
practitioners (NPPs) using a survey
instrument and methods highly
consistent with those of the SMS and
the supplemental surveys used prior to
CY 2010. We note that in CY 2010, for
oncology, clinical laboratories, and
independent diagnostic testing facilities
(IDTFs), we continued to use the
supplemental survey data to determine
practice expense per hour (PE/HR)
values (74 FR 61752). Beginning in CY
2010, we provided for a 4-year
transition for the new PE RVUs using
the updated PE/HR data. In CY 2012,
the third year of the transition, PE RVUs
are calculated based on a 75/25 blend of
the new PE RVUs developed using the
PPIS data and the previous PE RVUs
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based on the SMS and supplemental
survey data.
3. Resource-Based Malpractice RVUs
Section 4505(f) of the BBA amended
section 1848(c) of the Act to require that
we implement resource-based
malpractice RVUs for services furnished
on or after CY 2000. The resource-based
malpractice RVUs were implemented in
the PFS final rule with comment period
published November 2, 1999 (64 FR
59380). The MP RVUs were based on
malpractice insurance premium data
collected from commercial and
physician-owned insurers from all the
States, the District of Columbia, and
Puerto Rico. In the CY 2010 PFS final
rule with comment period (74 FR
61758), we implemented the Second
Five-Year Review and update of the
malpractice RVUs. In the CY 2011 PFS
final rule with comment period, we
described our approach for determining
malpractice RVUs for new or revised
codes that become effective before the
next Five-Year Review and update (75
FR 73208). Accordingly, to develop the
CY 2012 malpractice RVUs for new or
revised codes we crosswalked the new
or revised code to the malpractice RVUs
of a similar source code and adjusted for
differences in work (or, if greater, the
clinical labor portion of the fully
implemented PE RVUs) between the
source code and the new or revised
code.
4. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act
requires that we review all RVUs no less
often than every 5-years. The First FiveYear Review of Work RVUs was
published on November 22, 1996 (61 FR
59489) and was effective in 1997. The
Second Five-Year Review of Work RVUs
was published in the CY 2002 PFS final
rule with comment period (66 FR
55246) and was effective in 2002. The
Third Five-Year Review of Work RVUs
was published in the CY 2007 PFS final
rule with comment period (71 FR
69624) and was effective on January 1,
2007. The Fourth Five-Year Review of
Work RVUs was initiated in the CY
2010 PFS final rule with comment
period where we solicited candidate
codes from the public for this review (74
FR 61941). Proposed revisions to work
RVUs and corresponding changes to PE
and malpractice RVUs affecting
payment for physicians’ services for the
Fourth Five-Year Review of Work RVUs
were published in a separate Federal
Register notice on June 6, 2011 (76 FR
32410). We have reviewed public
comments, made adjustments to our
proposals in response to comments, as
appropriate, and included final values
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in this final rule with comment period,
effective for services furnished
beginning January 1, 2012.
In 1999, the AMA RUC established
the Practice Expense Advisory
Committee (PEAC) for the purpose of
refining the direct PE inputs. Through
March 2004, the PEAC provided
recommendations to CMS for over 7,600
codes (all but a few hundred of the
codes currently listed in the AMA’s
Current Procedural Terminology (CPT)
codes). As part of the CY 2007 PFS final
rule with comment period (71 FR
69624), we implemented a new bottomup methodology for determining
resource-based PE RVUs and
transitioned the new methodology over
a 4-year period. A comprehensive
review of PE was undertaken prior to
the 4-year transition period for the new
PE methodology from the top-down to
the bottom-up methodology, and this
transition was completed in CY 2010. In
CY 2010, we also incorporated the new
PPIS data to update the specialtyspecific PE/HR data used to develop PE
RVUs, adopting a 4-year transition to PE
RVUs developed using the PPIS data.
In the CY 2005 PFS final rule with
comment period (69 FR 66236), we
implemented the First Five-Year Review
of the malpractice RVUs (69 FR 66263).
Minor modifications to the methodology
were addressed in the CY 2006 PFS
final rule with comment period (70 FR
70153). The Second Five-Year Review
and update of resource-based
malpractice RVUs was published in the
CY 2010 PFS final rule with comment
period (74 FR 61758) and was effective
in CY 2010.
In addition to the Five-Year Reviews,
beginning for CY 2009, CMS and the
AMA 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 section 3134 of the
Affordable Care Act, which requires the
agency to periodically identify, review
and adjust values for potentially
misvalued codes with an emphasis on
the following categories: (1) Codes and
families of codes for which there has
been the fastest growth; (2) codes or
families of codes that have experienced
substantial changes in practice
expenses; (3) codes that are recently
established for new technologies or
services; (4) multiple codes that are
frequently billed in conjunction with
furnishing a single service; (5) codes
with low relative values, particularly
those that are often billed multiple
times for a single treatment; (6) codes
which have not been subject to review
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since the implementation of the RBRVS
(the so-called ‘Harvard valued codes’);
and (7) other codes determined to be
appropriate by the Secretary.
5. Application of Budget Neutrality to
Adjustments of RVUs
Budget neutrality typically requires
that expenditures not increase or
decrease as a result of changes or
revisions to policy. However, section
1848(c)(2)(B)(ii)(II) of the Act requires
adjustment only if the change in
expenditures resulting from the annual
revisions to the PFS exceeds a threshold
amount. Specifically, adjustments in
RVUs for a year may not cause total PFS
payments to differ by more than $20
million from what they would have
been if the adjustments were not made.
In accordance with section
1848(c)(2)(B)(ii)(II) of the Act, if
revisions to the RVUs cause
expenditures to change by more than
$20 million, we make adjustments to
ensure that expenditures do not increase
or decrease by more than $20 million.
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B. Components of the Fee Schedule
Payment Amounts
To calculate the payment for every
physician’s service, the components of
the fee schedule (physician work, PE,
and malpractice RVUs) are adjusted by
geographic practice cost indices (GPCIs).
The GPCIs reflect the relative costs of
physician work, PE, and malpractice in
an area compared to the national
average costs for each component.
RVUs are converted to dollar amounts
through the application of a CF, which
is calculated by CMS’ Office of the
Actuary (OACT).
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 × GPCI work) +
(RVU PE × GPCI PE) + (RVU
Malpractice × GPCI Malpractice)] ×
CF.
C. Most Recent Changes to the Fee
Schedule
The CY 2011 PFS final rule with
comment period (75 FR 73170)
implemented changes to the PFS and
other Medicare Part B payment policies.
It also finalized many of the CY 2010
interim RVUs and implemented interim
RVUs for new and revised codes for CY
2011 to ensure that our payment
systems are updated to reflect changes
in medical practice and the relative
values of services. The CY 2011 PFS
final rule with comment period also
addressed other policies, as well as
certain provisions of the Affordable Care
Act and the Medicare Improvements for
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Patients and Providers Act of 2008
(MIPPA).
In the CY 2011 PFS final rule with
comment period, we announced the
following for CY 2011: the total PFS
update of ¥10.1 percent; the initial
estimate for the sustainable growth rate
of ¥13.4 percent; and the conversion
factor (CF) of $25.5217. These figures
were calculated based on the statutory
provisions in effect on November 2,
2010, when the CY 2011 PFS final rule
with comment period was issued.
On December 30, 2010, we published
a correction notice (76 FR 1670) to
correct several technical and
typographical errors that occurred in the
CY 2011 PFS final rule with comment
period. This correction notice
announced a revised CF for CY 2011 of
$25.4999, which was in accordance
with the statutory provisions in effect as
of November 2, 2010, the date the CY
2011 PFS final rule with comment
period was issued.
On November 30, 2010, the Physician
Payment and Therapy Relief Act of 2010
(PPATRA) (Pub. L. 111–286) was signed
into law. Section 3 of Pub. L. 111–286
modified the policy finalized in the CY
2011 PFS final rule with comment
period (75 FR 73241), effective January
1, 2011, regarding the payment
reduction applied to multiple therapy
services provided to the same patient on
the same day in the office setting by one
provider and paid for under the PFS
(hereinafter, the therapy multiple
procedure payment reduction (MPPR)).
The PPATRA provision changed the
therapy MPPR percentage from 25 to 20
percent of the PE component of
payment for the second and subsequent
‘‘always’’ therapy services furnished in
the office setting on the same day to the
same patient by one provider, and
excepted the payment reductions
associated with the therapy MPPR from
budget neutrality under the PFS.
On December 15, 2010, the Medicare
and Medicaid Extenders Act of 2010
(MMEA) (Pub. L. 111–309) was signed
into law. Section 101 of the MMEA
provided for a 1-year zero percent
update for the CY 2011 PFS. As a result
of the MMEA, the CY 2011 PFS
conversion factor was revised to
$33.9764.
II. Provisions of the Final Rule for the
Physician Fee Schedule
A. Resource-Based Practice Expense
(PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of
the resources used in furnishing the
service that reflects the general
categories of physician and practitioner
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73035
expenses, such as office rent and
personnel wages but excluding
malpractice expenses, as specified in
section 1848(c)(1)(B) of the Act. Section
121 of the Social Security Amendments
of 1994 (Pub. L. 103–432), enacted on
October 31, 1994, required us to develop
a methodology for a resource-based
system for determining PE RVUs for
each physician’s service. We develop PE
RVUs by looking at the direct and
indirect physician 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. In
addition, we note that section
1848(c)(2)(B)(ii)(II) of the Act provides
that adjustments in RVUs for a year may
not cause total PFS payments to differ
by more than $20 million from what
they would have been if the adjustments
were not made. Therefore, if revisions to
the RVUs cause expenditures to change
by more than $20 million, we make
adjustments to ensure that expenditures
do not increase or decrease by more
than $20 million. We refer readers to the
CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for
a more detailed history of the PE
methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We use a bottom-up approach to
determine the direct PE by adding the
costs of the resources (that is, the
clinical staff, equipment, and supplies)
typically required to provide each
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 based on our
review of recommendations received
from the AMA RUC. For a detailed
explanation of the bottom-up direct PE
methodology, including examples, we
refer readers to the Five-Year Review of
Work Relative Value Units Under the
PFS and Proposed Changes to the
Practice Expense Methodology proposed
notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71
FR 69629).
b. Indirect Practice Expense per Hour
Data
We use survey data on indirect
practice expenses incurred per hour
worked in developing the indirect
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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), which was expanded
(relative to the SMS) to include
nonphysician practitioners (NPPs) paid
under the PFS.
The PPIS is a multispecialty,
nationally representative, PE survey of
both physicians and NPPs using a
consistent 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 healthcare
professional groups. We believe the
PPIS is the most comprehensive source
of PE survey information available to
date. Therefore, we used the PPIS data
to update the PE/HR data for almost all
of the Medicare-recognized specialties
that participated in the survey for the
CY 2010 PFS.
When we changed over to the PPIS
data beginning 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
finalized a 4-year transition (75 percent
old/25 percent new for CY 2010, 50
percent old/50 percent new for CY 2011,
25 percent old/75 percent new for CY
2012, and 100 percent new for CY 2013)
from the previous PE RVUs to the PE
RVUs developed using the new PPIS
data.
Section 303 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) added section
1848(c)(2)(H)(i) of the Act, which
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.
We do not use the PPIS data for
reproductive endocrinology, sleep
medicine, and spine surgery since these
specialties are not separately recognized
by Medicare, nor do we have a method
to blend these data with Medicarerecognized specialty data.
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Supplemental survey data on
independent labs, from the College of
American Pathologists, were
implemented for payments 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 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 medical
oncology, independent laboratories, and
IDTFs were updated to CY 2006 using
the MEI to put them on a comparable
basis with the PPIS data.
Previously, we have 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 use
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
physician 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).
There are four specialties whose
utilization data will be newly
incorporated into ratesetting for CY
2012. We proposed to use proxy PE/HR
values for these specialties by
crosswalking values from other, similar
specialties as follows: Speech Language
Pathology from Physical Therapy;
Hospice and Palliative Care from All
Physicians; Geriatric Psychiatry from
Psychiatry; and Intensive Cardiac
Rehabilitation from Cardiology.
Additionally, since section 1833(a)(1)(K)
of the Act (as amended by section 3114
of the Affordable Care Act) requires that
payment for services provided by a
certified nurse midwife be paid at 100
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percent of the PFS amount, this
specialty will no longer be excluded
from the ratesetting calculation. We
proposed to crosswalk the PE\HR data
from Obstetrics/gynecology to Certified
Nurse Midwife. These proposed changes
were reflected in the ‘‘PE HR’’ file
available on the CMS Web site under
the supporting data files for the CY 2012
PFS proposed rule at https://
www.cms.gov/PhysicianFeeSched/.
Comment: Several commenters
supported the proposals to incorporate
the data into ratesetting for CY 2012.
Most of these commenters also
supported the proposed proxy PE/HR
value crosswalks. One commenter,
however, objected to using the
Psychiatry PE/HR crosswalk for
Geriatric Psychiatry. The commenter
noted that many of the specific geriatric
issues such as mobility, hearing
impairments, and cognitive
impairments that increase the expenses
for geriatrician’s treating frail adults also
apply to the practice expenses for
geriatric psychiatrists. Therefore, the
commenter argued that CMS should use
a blend of information from Geriatric
Medicine and Psychiatry as the PE/HR
crosswalk.
Response: We appreciate the broad
support for the proposal to incorporate
utilization data from these specialties
into ratesetting for CY 2012. We
understand the commenters’ concerns
in terms of geriatric psychiatry and
agree that in many ways the patient
population for geriatric psychiatry may
resemble the patient population for
geriatric medicine. However, the
primary drivers of the indirect practice
expense per hour for these specialties
are the administrative staff category and
the office rent category. We disagree
with the commenter that the
administrative staff and office space
requirements for geriatric psychiatrists
more closely resemble the
administrative staff and office space
requirements for geriatrics than for
psychiatry. In general, these categories
are more likely to be driven by the types
of services provided than the patient
population served.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposals to
update the PE/HR data as reflected in
the ‘‘PE HR’’ file available on the CMS
Web site under the supporting data files
for the CY 2012 PFS final rule with
comment period at https://www.cms.gov/
PhysicianFeeSched/.
As provided in the CY 2010 PFS final
rule with comment period (74 FR
61751), CY 2012 is the third year of the
4-year transition to the PE RVUs
calculated using the PPIS data.
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Therefore, in general, the CY 2012 PE
RVUs are a 25 percent/75 percent blend
of the previous PE RVUs based on the
SMS and supplemental survey data and
the new PE RVUS developed using the
PPIS data as described previously.
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.
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(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 required to provide the
services. The costs of these resources are
calculated from the refined direct PE
inputs in our PE database. For example,
if one service has a direct cost sum of
$400 from our PE database and another
service has a direct cost sum of $200,
the direct portion of the PE RVUs of the
first service would be twice as much as
the direct portion of the PE RVUs for the
second service.
(2) Indirect Costs
Section II.A.2.b. of this final rule with
comment period describes the current
data sources for specialty-specific
indirect costs used in our PE
calculations. We allocate 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 incorporate the
survey data described earlier in the PE/
HR discussion. The general approach to
developing the indirect portion of the
PE RVUs is described 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 perform the service
to determine an initial indirect
allocator. For example, if the direct
portion of the PE RVUs for a given
service were 2.00 and direct costs, on
average, represented 25 percent of total
costs for the specialties that performed
the service, the initial indirect allocator
would be 6.00 since 2.00 is 25 percent
of 8.00 and 6.00 is 75 percent of 8.00.
• We then 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
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add 6.00 plus 4.00 (since the 4.00 work
RVUs are greater than the 1.50 clinical
labor portion) to get an indirect allocator
of 10.00. In the absence of any further
use of the survey data, the relative
relationship between the indirect cost
portions of the PE RVUs for any two
services would be determined by the
relative relationship between these
indirect cost allocators. For example, if
one service had an indirect cost
allocator of 10.00 and another service
had an indirect cost allocator of 5.00,
the indirect portion of the PE RVUs of
the first service would be twice as great
as the indirect portion of the PE RVUs
for the second service.
• We next incorporate the specialtyspecific indirect PE/HR data into the
calculation. As a relatively extreme
example for the sake of simplicity,
assume in our previous example that,
based on the survey data, the average
indirect cost of the specialties
performing the first service with an
allocator of 10.00 was half of the average
indirect cost of the specialties
performing the second service with an
indirect allocator of 5.00. In this case,
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 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 Medicare makes a
separate payment to the facility for its
costs of furnishing a service, the facility
PE RVUs are generally lower than the
nonfacility PE RVUs.
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), each of
which may be performed independently
or by different providers, or they may be
performed together as a ‘‘global’’
service. When services have PC and TC
components that can be billed
separately, the payment for the global
component equals the sum of the
payment for the TC and PC. This is a
result of using a weighted average of the
ratio of indirect to direct costs across all
the specialties that furnish the global
components, TCs, and PCs; that is, we
apply the same weighted average
indirect percentage factor to allocate
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indirect expenses to the global
components, 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 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 current aggregate
pool of direct PE costs. This is the
product of the current aggregate PE
(aggregate direct and indirect) RVUs, the
CF, and the average direct PE percentage
from the survey data.
Step 3: Calculate the aggregate pool of
direct costs. This is the sum of the
product of the direct costs for each
service 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 so that the aggregate direct
cost pool does not exceed the current
aggregate direct cost pool and apply it
to the direct costs from Step 1 for each
service.
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
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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
components.
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 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 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 percentage (direct
PE RVUs/direct percentage) + clinical
PE RVUs.
(Note: For global services, the indirect
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 2, 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
RVUs, clinical PE RVUs, or both
depending on whether the service is a
global service and whether the clinical
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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 specialtyspecific adjusted indirect PE allocators
for all PFS services for a specialty by
adding the product of the adjusted
indirect PE allocator for each service
and the utilization data for that service.
Step 13: Using the specialty-specific
indirect PE/HR data, calculate specialtyspecific 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 physician time
for the service, and the specialty’s
utilization for the service across all
services performed by the specialty.
Step 14: Using the results of Step 12
and Step 13, calculate the specialtyspecific 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
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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 components,
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
component.)
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
primarily because certain specialties are
excluded from the PE RVU calculation
for ratesetting purposes, but all
specialties are included for purposes of
calculating the final BN adjustment.
(See ‘‘Specialties excluded from
ratesetting calculation’’ later in this
section.)
(5) Setup File Information
• Specialties excluded from
ratesetting calculation: For the purposes
of calculating the PE RVUs, we exclude
certain specialties, such as certain
nonphysician practitioners paid at a
percentage of the PFS and low-volume
specialties, from the calculation. These
specialties are included for the purposes
of calculating the BN adjustment. They
are displayed in Table 1. We note that
since specialty code 97 (physician
assistant) is paid at a percentage of the
PFS and therefore excluded from the
ratesetting calculation, this specialty has
been added to the table for CY 2012.
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• 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
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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. 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.
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• Work RVUs: The setup file contains
the work RVUs from this final rule with
comment period.
(6) Equipment Cost Per Minute
The equipment cost per minute is
calculated as:
(1/(minutes per year * usage)) * price *
((interest rate/(1-(1/((1 + interest
rate)¥ 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 = equipment utilization assumption;
0.75 for certain expensive diagnostic
imaging equipment (see 74 FR 61753
through 61755 and section II.A.3. of the
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period) and 0.5 for others.
price = price of the particular piece of
equipment.
interest rate = 0.11.
life of equipment = useful life of the
particular piece of equipment.
maintenance = factor for maintenance; 0.05.
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This interest rate was proposed and
finalized during rulemaking for CY 1998
PFS (62 FR 33164). We solicit comment
regarding reliable data on current
prevailing loan rates for small
businesses.
Comment: Several commenters,
including the AMA RUC stated that
CMS should establish a periodic review
of the interest rate assumption for
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equipment costs using current interest
rate data from the Small Business
Association and the Federal Reserve and
allow for public comment on periodic
updates. The RUC also noted that
current market volatility exacerbates the
need to establish such a process. One
commenter noted that exaggerated
assumptions about equipment interest
rates inflates services with high
equipment cost inputs relative to
services without high equipment cost
inputs, such as most primary care
services. Therefore, CMS should update
the equipment interest rate assumption.
In addition to examining the interest
rate assumption, the RUC requested that
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CMS review the assumptions regarding
useful life of equipment and yearly
maintenance costs associated with
maintaining high cost equipment and
allow for comment on the
methodologies used in developing these
assumptions.
Response: We appreciate the public
comments we received in response to
our request regarding reliable data on
current prevailing loan rates for small
businesses. We will examine the
suggestions of the AMA RUC and the
other commenters in order to inform
any future rulemaking on this issue.
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3. Changes to Direct PE Inputs
In this section, we discuss other
specific CY 2012 proposals and changes
related to direct PE inputs. The changes
we proposed and are finalizing are
included in the proposed CY 2012
direct PE database, which is available
on the CMS Web site under the
supporting data files for the CY 2012
PFS final rule with comment period at
https://www.cms.gov/
PhysicianFeeSched/.
a. Inverted Equipment Minutes
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It came to our attention that the
minutes allocated for two particular
equipment items have been inverted.
This inversion affected three codes:
37232 (Revascularization, endovascular,
open or percutaneous, tibial/peroneal
artery, unilateral, each additional vessel;
with transluminal angioplasty (List
separately in addition to code for
primary procedure)), 37233
(Revascularization, endovascular, open
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or percutaneous, tibial/peroneal artery,
unilateral, each additional vessel; with
atherectomy, includes angioplasty
within the same vessel, when performed
(List separately in addition to code for
primary procedure)), and 37234
(Revascularization, endovascular, open
or percutaneous, tibial/peroneal artery,
unilateral, each additional vessel; with
transluminal stent placement(s),
includes angioplasty within the same
vessel, when performed (List separately
in addition to code for primary
procedure)). In each case, the number of
minutes allocated to the ‘‘printer, dye
sublimation (photo, color)’’ (ED031)
should have been appropriately
allocated to the ‘‘stretcher’’ (EF018). The
number of minutes allocated to the
stretcher should have been
appropriately allocated to the printer.
Therefore, we proposed input
corrections to the times associated with
the two equipment items in the three
codes.
Comment: Several commenters agreed
with these corrections as proposed.
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Response: We appreciate the support
for these proposed revisions, as well as
the information provided that allowed
us to make them.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to
modify the direct PE database by
correcting the input errors associated
with the two equipment items in the
three codes. The CY 2012 direct PE
database reflects these changes and is
available on the CMS Web site under
the supporting data files for the CY 2012
PFS final rule with comment period at
https://www.cms.gov/
PhysicianFeeSched/.
b. Labor and Supply Input Duplication
We recently identified a number of
CPT codes with inadvertently
duplicated labor and supply inputs in
the PE database. We proposed to remove
the duplicate labor and supply inputs in
the CY 2012 database as detailed in
Table 3.
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Comment: Many commenters agreed
with the proposal to remove the
duplicate labor and supply inputs from
the direct PE database. One commenter
agreed with the proposal but also stated
that the inputs for CPT code 76813 may
not reflect the use of current technology.
Response: We appreciate the broad
support for the proposal. We refer
stakeholders who do not believe that the
direct PE database reflects current use
technology for particular codes to the
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public process for nominating
potentially misvalued codes in section
II.B. of this final rule with comment
period.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to
remove the duplicate labor and supply
inputs in the CY 2012 database as
detailed in Table 3. The CY 2012 direct
PE database reflects these changes and
is available on the CMS Web site under
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73043
the supporting data files for the CY 2012
PFS final rule with comment period at
https://www.cms.gov/
PhysicianFeeSched/.
c. AMA RUC Recommendations for
Moderate Sedation Direct PE Inputs
For services described by certain
codes, the direct PE database includes
nonfacility inputs that reflect the
assumption that moderate sedation is
inherent in the procedure. These codes
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are listed in Table 4. The AMA RUC has
recently provided CMS with a
recommendation that standardizes the
nonfacility direct PE inputs that account
for moderate sedation as typically
furnished as part of these services.
Specifically, the RUC recommended
that the direct PE inputs allocated for
moderate sedation include the
following:
• Clinical Labor Inputs: Registered
Nurse (L051A) time that includes two
minutes of time to initiate sedation, the
number of minutes associated with the
physician intra-service work time, and
15 minutes for every hour of patient
recovery time for post-service patient
monitoring. Supply Inputs: ‘‘Pack,
conscious sedation’’ (SA044) that
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includes: an angiocatheter 14g–24g,
bandage, strip 0.75in × 3in, catheter,
suction, dressing, 4in × 4.75in
(Tegaderm), electrode, ECG (single),
electrode, ground, gas, oxygen, gauze,
sterile 4in × 4in, gloves, sterile, gown,
surgical, sterile, iv infusion set, kit, iv
starter, oxygen mask (1) and tubing (7ft),
pulse oximeter sensor probe wrap, stop
cock, 3-way, swab-pad, alcohol, syringe
1ml, syringe-needle 3ml 22–26g, tape,
surgical paper 1in (Micropore),
tourniquet, and non-latex 1in × 18in.
• Equipment Inputs: ‘‘Table,
instrument, mobile’’ (EF027), ‘‘ECG, 3channel (with SpO2, NIBP, temp, resp)’’
(EQ011), ‘‘IV infusion pump’’ (EQ032),
‘‘pulse oxymetry recording software
(prolonged monitoring)’’ (EQ212), and
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‘‘blood pressure monitor, ambulatory,
w-battery charger’’ (EQ269).
We have reviewed this
recommendation and generally agree
with these inputs. However, we note
that the equipment item ‘‘ECG, 3channel (with SpO2, NIBP, temp, resp)’’
(EQ011) incorporates the functionality
of the equipment items ‘‘pulse oxymetry
recording software (prolonged
monitoring)’’ (EQ212), and ‘‘blood
pressure monitor, ambulatory, w-battery
charger’’ (EQ269). Therefore, we did not
include these two items as standard
nonfacility inputs for moderate sedation
in our proposal to accept the AMA RUC
recommendation with the refinement as
stated.
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Comment: Several commenters,
including the AMA RUC, agreed with
CMS’ proposal to accept the
recommendations for moderate sedation
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direct PE inputs with the stated
refinements. One commenter suggested
that a particular code on the list should
be removed since moderate sedation is
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not typically performed when that
service is furnished.
Response: We appreciate the support
for our proposal to accept the
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recommendation as well as those in
favor of our refinements. We
acknowledge and appreciate the
perspectives of the commenter who
suggested that a particular code should
not include moderate sedation.
However, we note that we generally
include nonfacility direct PE inputs for
moderate sedation for all services
valued in the nonfacility setting and
reported using CPT codes that are
identified by the CPT Editorial Panel as
having moderate sedation as inherent to
the procedure.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to
accept the AMA RUC recommendation
with the refinement as stated. The CY
2012 direct PE database reflects these
changes and is available on the CMS
Web site under the supporting data files
for the CY 2012 PFS final rule with
comment period at https://www.cms.gov/
PhysicianFeeSched/.
d. Updates to Price and Useful Life 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 final
rule with comment period.
During 2010, we received a request to
update the price of ‘‘tray, bone marrow
biopsy-aspiration’’ (SA062) from $24.27
to $34.47. The request included
multiple invoices that documented
updated prices for the supply item. We
also received a request to update the
useful life of ‘‘holter monitor’’ (EQ127)
from 7 years to 5 years, based on its
entry in the AHA’s publication,
’’Estimated Useful Lives of Depreciable
Hospital Assets,’’ which we use as a
standard reference. In each of these
cases, we proposed to accept the
updated inputs, as requested. The CY
2012 direct PE database reflects these
proposed changes and is available on
the CMS Web site under the supporting
data files for the CY 2012 PFS final rule
with comment period at https://
www.cms.gov/PhysicianFeeSched/.
Comment: Several commenters
expressed support for the proposal to
update the supply items as proposed.
MedPAC expressed continued
misgivings that this process for updating
prices is flawed because it relies on
voluntary requests from stakeholders
who have a financial stake in the
process. Therefore, MedPAC believes
that stakeholders are unlikely to provide
CMS with evidence that prices for
supplies and equipment have declined
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because it would lead to lower RVUs for
particular services. MedPAC also called
for CMS to establish an objective
process to regularly update the prices of
medical supplies and equipment to
reflect market prices, especially for
expense items.
Response: We appreciate the general
support for the proposal. We also
appreciate MedPAC’s comments and
understand the commission’s concerns.
As we have previously stated, we
continue to believe it is important to
establish a periodic and transparent
process to update the cost of high-cost
items to reflect typical market prices in
our ratesetting methodology, and we
continue to study the best way to
establish such a process. We remind
stakeholders that we have previously
stated our difficulty in obtaining
accurate pricing information, and this
transparent process offers the
opportunity for the community to object
to increases in price inputs for
particular items by providing accurate
information about lower prices available
to the practitioner community. We
remind stakeholders that PFS payment
rates are developed within a budget
neutral system, and any increases in
price inputs for particular supply items
result in corresponding decreases to the
relative value of all other direct practice
expense inputs. Had any interested
stakeholder presented information that
indicated that increasing the price input
for the bone marrow biopsy-aspiration
was inappropriate, we would have
considered evidence of lower available
prices prior to amending the price input
in the CY 2012 direct PE database.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to
accept the updated inputs, as requested.
The CY 2012 direct PE database reflects
these changes and is available on the
CMS Web site under the supporting data
files for the CY 2012 PFS final rule with
comment period at https://www.cms.gov/
PhysicianFeeSched/.
4. Development of Code-Specific PE
RVUs
When creating G codes, we often
develop work, PE, and malpractice
RVUs by crosswalking the RVUs from
similar (reference) codes. In most of
these cases, the PE RVUs are directly
crosswalked pending the availability of
utilization data. Once that data is
available, we crosswalk the direct PE
inputs and develop PE RVUs using the
regular practice expense methodology,
including allocators that are derived
from utilization data. For CY 2012, we
are using this process to develop PE
RVUs for the following services: G0245
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(Initial physician evaluation and
management of a diabetic patient with
diabetic sensory neuropathy resulting in
a loss of protective sensation (LOPS)
which must include: (1) The diagnosis
of LOPS, (2) a patient history, (3) a
physical examination that consists of at
least the following elements: (a) Visual
inspection of the forefoot, hindfoot and
toe web spaces, (b) evaluation of a
protective sensation, (c) evaluation of
foot structure and biomechanics, (d)
evaluation of vascular status and skin
integrity, and (e) evaluation and
recommendation of footwear and (4)
patient education); G0246 (Follow-up
physician evaluation and management
of a diabetic patient with diabetic
sensory neuropathy resulting in a loss of
protective sensation (LOPS) to include
at least the following: (1) A patient
history, (2) a physical examination that
includes: (a) Visual inspection of the
forefoot, hindfoot and toe web spaces,
(b) evaluation of protective sensation,
(c) evaluation of foot structure and
biomechanics, (d) evaluation of vascular
status and skin integrity, and (e)
evaluation and recommendation of
footwear, and (3) patient education);
G0247 (Routine foot care by a physician
of a diabetic patient with diabetic
sensory neuropathy resulting in a loss of
protective sensation (LOPS) to include,
the local care of superficial wounds (for
example, superficial to muscle and
fascia) and at least the following if
present: (1) Local care of superficial
wounds, (2) debridement of corns and
calluses, and (3) trimming and
debridement of nails); G0341
(Percutaneous islet cell transplant,
includes portal vein catheterization and
infusion); G0342 (Laparoscopy for islet
cell transplant, includes portal vein
catheterization and infusion); G0343
(Laparotomy for islet cell transplant,
includes portal vein catheterization and
infusion); and G0365 (Vessel mapping
of vessels for hemodialysis access
(services for preoperative vessel
mapping prior to creation of
hemodialysis access using an
autogenous hemodialysis conduit,
including arterial inflow and venous
outflow)). The values in Addendum B
reflect the updated PE RVUs.
In addition, there is a series of Gcodes describing surgical pathology
services with PE RVUs historically
valued outside of the regular PE
methodology. These codes are: G0416
(Surgical pathology, gross and
microscopic examination for prostate
needle saturation biopsy sampling, 1–20
specimens); G0417 (Surgical pathology,
gross and microscopic examination for
prostate needle saturation biopsy
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through the PE methodology. Several
commenters, however, urged CMS to
reconsider using the standard PE
methodology to develop PE RVUs for
this service since the resulting payment
rate for G0365 would be significantly
lower than the current rate.
Response: We appreciate the general
support for proposal. We are also
grateful to those commenters who
alerted us to the significant change in
PE RVUs for G0365. In developing the
proposal, we did not expect the newly
developed PE RVUs for G0365 to change
significantly from those previously
established outside the methodology. In
re-examining the disparities between
the CY 2011 PE RVUs and those that
appeared in the proposed rule, we
discovered that an inadvertent data
entry error in the proposed direct PE
database had led to the development
and display of erroneous PE RVUs.
Because the commenters’ objections to
the proposal in methodology resulted
directly from concerns about the
resulting PE RVUs, we believe that those
concerns are addressed by the
correction of direct PE database error
and the development of PE RVUs for
G0365 that are more similar to the
current PE RVUs.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to
develop PE RVUs through the
methodologies explained in the
proposal. The final CY 2012 RVUs for
these codes are displayed in Addendum
B to this final rule with comment
period.
Comment: Several commenters
alerted CMS to inaccurate post-service
times and rounding discrepancies in the
physician time file that did not
correspond with the intent of the
proposal. Specifically, commenters
urged CMS to recalculate the times for
group education/therapy to ensure they
reflect the intent of the proposal.
Response: We appreciate being
informed of these inaccuracies and
discrepancies. As the commenters
noted, the physician time file as
displayed in the supporting web files for
the CY 2012 PFS proposed rule
included inappropriate post-service
times and rounding discrepancies for
some of the codes addressed in the
proposal. We have addressed these
issues in the physician time file used in
developing the PE RVUs for CY 2012.
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5. Physician Time for Select Services
As we describe in section II.A.2.f. of
this final rule with comment period, in
creating the indirect practice cost index,
we 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 physician time for the service, and
the specialty’s utilization for the service
across all services performed by the
specialty.
During a review of the physician time
data for the CY 2012 PFS rulemaking,
we noted an anomaly regarding the
physician time allotted to a series of
group service codes that are listed in
Table 5. We believe that the time
associated with these codes reflects the
typical amount of time spent by the
practitioner in furnishing the group
service. However, because the services
are billed per patient receiving the
service, the time for these codes should
be divided by the typical number of
patients per session. In reviewing the
data used in the valuation of work RVUs
for these services, we noted that in one
vignette for these services, the typical
group session consisted of 6 patients.
Therefore we proposed adjusted times
for these services based on 6 patients.
However, we sought comment on the
typical number of patients seen per
session for each of these services.
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sampling, 21–40 specimens); G0418
(Surgical pathology, gross and
microscopic examination for prostate
needle saturation biopsy sampling, 41–
60 specimens); and G0419 (Surgical
pathology, gross and microscopic
examination for prostate needle
saturation biopsy sampling, greater than
60 specimens.) The PE RVUs for these
codes were established as described in
the CY 2009 PFS final rule with
comment period (73 FR 69751). In
reviewing these values for CY 2012, we
noted that because the PE RVUs
established through rulemaking in CY
2009 were neither developed using the
regular PE methodology nor directly
crosswalked from other codes, the PE
RVUs for these codes were not adjusted
to account for the CY 2011 MEI rebasing
and revising, which is discussed in the
CY 2011 PFS final rule with comment
period (75 FR 73262). While it was
technically appropriate to insulate the
PE RVUs from that adjustment in CY
2011, upon further review, we believe
adjusting these PE RVUs would result in
more accurate payment rates relative to
the RVUs for other PFS services.
Therefore, we proposed to adjust the PE
RVUs for these codes by 1.182, the
adjustment rate that accounted for the
MEI rebasing and revising for CY 2011.
The PE RVUs in Addendum B to the CY
2011 PFS proposed rule reflected the
proposed updates.
Comment: In general, commenters
were supportive of the proposal to
develop PE RVUs for these services
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Comment: Several commenters,
including the AMA RUC, submitted
useful information regarding the typical
group size for particular services. In
many cases, however, commenters
expressed concerns about this proposal
that stretched beyond the scope of the
proposed rule, including concerns about
detrimental effect on work RVUs for the
services, inappropriate clinical
comparisons of unrelated services by
CMS, or Medicare or other payment
policy changes regarding appropriate
group sizes for billing or coverage
purposes.
Response: We did not propose any
changes to the work RVUs or other
policies related to these services. Our
proposal related to the physician time
data as used in the practice expense
methodology as we describe in section
II.A.2.f. of this final rule with comment
period. In creating the indirect practice
cost index, we calculate specialtyspecific 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 physician time
for the service, and the specialty’s
utilization for the service across all
services performed by the specialty. The
proposal addresses the times associated
for these codes only insofar as they
contribute to the aggregate pools of
indirect PE at the specialty level. In
formulating the proposal, we addressed
these services together because we
believe that these group services share
particular coding, not clinical,
characteristics that complicate the use
of time data in the practice expense
methodology. If appropriate, we would
address any changes to the work RVUs
or other polices in future rulemaking.
We appreciate all of the comments
regarding this proposal. In the following
paragraphs, we address how we will use
this submitted information in order to
set final time values for these codes—
• 90849 (Multiple-family group
psychotherapy);
• 90853 (Group psychotherapy (other
than of a multiple-family group); and
• 90857 (Interactive group
psychotherapy).
Comment: The AMA RUC
recommended that CMS postpone any
changes to the physician times for these
codes since these services are currently
under revision by the CPT Editorial
Panel and the AMA RUC intends to
provide CMS with new
recommendations in the near future.
Response: We appreciate that CPT
and the AMA RUC are both examining
these services, and we will consider any
codes or recommendations regarding
these services. Until then, we continue
to believe that because these services are
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billed per patient, the physician time for
the corresponding codes should be
divided by the typical number of
patients per session in order to arrive at
more appropriate PE RVUs across the
PFS. We note that the vignette for 90853
includes a typical group session of 6
patients. Therefore, pending new
recommendations from the AMA RUC,
we believe it would be appropriate to
establish physician time for this code as
2 pre-service minutes, 14 intra-service
minutes, and 8 post-service minutes
with the understanding that the total
resulting minutes is the product of these
and the number of patients in the group.
We believe that the typical group
session may be similar for 90857 based
on similar code descriptors, work RVUs,
and clinical vignettes. Therefore,
pending new recommendations from the
AMA RUC, we believe it would be
appropriate to establish physician time
for this code as 3 pre-service minutes,
9 intra-service minutes, and 10 postservice minutes with the understanding
that the total resulting minutes is the
product of these and the number of
patients in the group.
For 90849, we believe that it would be
most appropriate to wait for the new
recommendations prior to adjusting the
physician time because the typical
group size and typical patient size is
different, and we received no
information regarding the typical group
size.
• 92508 (Treatment of speech,
language, voice, communication, and/or
auditory processing disorder; group, 2
or more individuals)
Comment: Several commenters
pointed out that the CPT 92508 was
recently reviewed by the HCPAC and
that the recommended physician times
already are considered the appropriate
proration by the number of patients in
the group.
Response: We agree with the
commenter’s assessment and therefore,
believe it would be appropriate to
discard our proposed physician time
changes for CPT 92508 and maintain the
current time of 2 minutes pre-time, 17
minutes intra-time and 3 minutes posttime for CY 2012.
• 96153 (Health and behavior
intervention, each 15 minutes, face-toface; group (2 or more patients))
Comment: The AMA RUC reported
that because the February 2001 HCPAC
recommendation indicated that the
typical number of people receiving this
service per group was 6 individuals,
CMS’ proposal to divide the physician
time by six is appropriate.
Response: We appreciate the
information submitted by the AMA RUC
and thank them for pointing out initially
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the inaccuracy in the post service
minutes. Considering this information,
we believe it is appropriate to amend
the physician time for CPT code 96153
to 1 pre-service minute, 3 intra-service
minutes, and 1 post-service minute with
the understanding that the total
resulting minutes is the product of these
and the number of patients in the group.
• 97150 (Therapeutic procedure(s),
group (2 or more individuals))
Comment: In its comment, the AMA
RUC noted that this code is scheduled
to be reviewed by the RUC early in
2012. Therefore, the AMA RUC
recommends that CMS postpone any
changes until receiving the new
recommendation. Another commenter
informed CMS that the typical group
size is two for this procedure.
Response: We appreciate the AMA
RUC’s comments and we will consider
any codes or recommendations
regarding these services. Until then, we
continue to believe that, because these
services are billed per patient, the
physician time for the corresponding
codes should be divided by the typical
number of patients per session in order
to arrive at more appropriate PE RVUs
across the PFS. We also appreciate the
other commenter’s information that two
patients are the typical group size for
this service. Therefore, pending the new
recommendation from the AMA RUC,
we believe it would be appropriate to
establish physician time for this code as
1 pre-service minute, 12 intra-service
minutes, and 2 post-service minutes
with the understanding that the total
resulting minutes is the product of these
and the number of patients in the group.
• 97804 (Medical nutrition therapy;
group (2 or more individual(s)), each 30
minutes)
Comment: The AMA RUC suggested
that CMS should rely on information
provided by the American Dietetic
Association for a specific typical
number of individuals in a group for
CPT code 97804. The American Dietetic
Association commented that groups of
four to six patients were typical when
this service is furnished.
Response: We appreciate the
information provided by the
commenters. Considering this
information, we believe it is appropriate
to amend the physician time for CPT
code 97804 to 2 pre-service minutes, 6
intra-service minutes, and 2 post-service
minutes with the understanding that the
total resulting minutes is the product of
these and the number of patients in the
group.
• G0109 (Diabetes outpatient selfmanagement training services, group
session (2 or more), per 30 minutes)
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Comment: A commenter submitted
information supporting a typical group
size of 6 patients for this service and
urged CMS to use that number in
determining the appropriate physician
time associated with the code.
Response: We appreciate the
commenter’s response. Considering this
information, we believe it is appropriate
to amend the physician time for CPT
code 97804 to 2 pre-service minutes, 5
intra-service minutes, and 2 post-service
minutes with the understanding that the
total resulting minutes is the product of
these and the number of patients in the
group.
• G0271 (Medical nutrition therapy,
reassessment and subsequent
intervention(s) following second referral
in same year for change in diagnosis,
medical condition, or treatment regimen
(including additional hours needed for
renal disease), group (2 or more
individuals), each 30 minutes), and
G0421 (Face-to-face educational services
related to the care of chronic kidney
disease; group, per session, per one
hour)
We received no comments regarding
the typical group time for these services.
However, given the similarities of these
services to CPT code 97804 (Medical
nutrition therapy; group (2 or more
individual(s)), each 30 minutes), we
believe it would be appropriate to use
the times for that code as a reasonable
crosswalk and establish physician time
for these codes as 2 pre-service minutes,
6 intra-service minutes, and 2 postservice minutes with the understanding
that the total resulting minutes is the
product of these and the number of
patients in the group.
After consideration of the public
comments and related information, we
are finalizing our proposed updates to
the physician time file, as amended for
certain codes as explicitly addressed in
this section. The final time values for
these codes can be found in the final CY
2012 Physician Time file, which is
available on the CMS Web site under
the supporting data files for the CY 2012
PFS proposed rule at https://
www.cms.gov/PhysicianFeeSched/.
As a result of our review, we also
proposed to update our physician time
file to reflect the physician time
associated with certain G-codes that had
previously been missing from the file.
We received no comments regarding
our proposal to update the physician
time file to reflect the physician time
associated with the G-codes that were
previously missing from the file.
Therefore, we are finalizing our updates
to the physician time file. The final time
values can be found in the final CY 2012
Physician Time file, which is available
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on the CMS Web site under the
supporting data files for the CY 2012
PFS proposed rule at https://
www.cms.gov/PhysicianFeeSched/.
B. Potentially Misvalued Services Under
the Physician Fee Schedule
1. Valuing Services Under the PFS
As discussed in section I. of this final
rule with comment period, in order to
value 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, practice expense
(PE), and malpractice. 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 physician time and
intensity in furnishing the service.’’
Additionally, the statute provides that
the work component shall include
activities that occur before and after
direct patient contact. Furthermore, the
statute specifies that with respect to
surgical procedures, the valuation of the
work component for the code must
reflect a ‘‘global’’ concept in which preoperative and post-operative physicians’
services related to the procedure are
also included.
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.’’ As discussed in detail in
sections I.A.2. and I.A.3. of this final
rule with comment period, the statute
also defines the PE and malpractice
components and provides specific
guidance in the calculation of the RVUs
for each of these components. 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
specifies that the ‘‘Secretary shall
determine a number of practice expense
relative value units for the services for
years beginning with 1999 based on the
relative practice expense resources
involved in furnishing the service.’’
Furthermore, 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. On March 23, 2010, the
Affordable Care Act was enacted,
further requiring the Secretary to
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periodically identify and review
potentially misvalued codes, and make
appropriate adjustments to the relative
values of those services identified as
being potentially misvalued. Section
3134(a) of the Affordable Care Act
added a new section 1848(c)(2)(K) to the
Act which 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
3134(a) of the Affordable Care Act also
added a new section 1848(c)(2)(L) to the
Act which requires the Secretary to
develop a process to validate the RVUs
of certain potentially misvalued codes
under the PFS, identified using the
same criteria used to identify potentially
misvalued codes, and to make
appropriate adjustments.
As discussed in section I.A.1. of this
final rule with comment period, we
generally establish physician work
RVUs for new and revised codes based
on our review of recommendations
received from the American Medical
Association Specialty Society Relative
Value Scale Update Committee (AMA
RUC). We also receive recommendations
from the AMA RUC regarding direct PE
inputs for services, which we evaluate
in order to develop the PE RVUs under
the PFS. The AMA RUC also provides
recommendations to us on the values for
codes that have been identified as
potentially misvalued. To respond to
concerns expressed by MedPAC, the
Congress, and other stakeholders
regarding accurate valuation of services
under the PFS, the AMA RUC created
the Five-Year Review Identification
Workgroup in 2006. In addition to
providing recommendations to us for
work RVUs and physician times, the
AMA RUC’s Practice Expense
Subcommittee reviews direct PE inputs
(clinical labor, medical supplies, and
medical equipment) for individual
services.
In accordance with section 1848(c) of
the Act, we determine appropriate
adjustments to the RVUs, taking into
account the recommendations provided
by the AMA RUC and MedPAC, explain
the basis of these adjustments, and
respond to public comments in the PFS
proposed and final rules. 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.
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2. Identifying, Reviewing, and
Validating the RVUs of Potentially
Misvalued Services Under the PFS
a. Background
In its March 2006 Report to the
Congress, MedPAC noted 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 for a number of reasons: For
example, MedPAC stated, ‘‘when a new
service is added to the physician fee
schedule, it may be assigned a relatively
high value because of the time,
technical skill, and psychological stress
that are often required to furnish that
service. Over time, the work required for
certain services would be expected to
decline as physicians become more
familiar with the service and more
efficient in furnishing it.’’ That is, the
amount of physician work needed to
furnish an existing service may decrease
when new technologies are
incorporated. Services can also become
overvalued when practice expenses
decline. This can happen when the
costs of equipment and supplies fall, or
when equipment is used more
frequently, reducing its cost per use.
Likewise, services can become
undervalued when physician work
increases or practice expenses rise. In
the ensuing years since MedPAC’s 2006
report, additional groups of potentially
misvalued services have been identified
by the Congress, CMS, MedPAC, the
AMA RUC, and other stakeholders.
In recent years CMS and the AMA
RUC have taken increasingly significant
steps to address potentially misvalued
codes. As MedPAC noted in its March
2009 Report to the Congress, in the
intervening years since MedPAC made
the initial recommendations, ‘‘CMS and
the AMA RUC have taken several steps
to improve the review process.’’ Most
recently, section 1848(c)(2)(K)(ii) of the
Act (as added by section 3134(a) of the
Affordable Care Act) directed the
Secretary to specifically examine, as
determined appropriate, potentially
misvalued services in seven categories
as follows:
• Codes and families of codes for
which there has been the fastest growth.
• Codes and families of codes that
have experienced substantial changes in
practice expenses.
• Codes that are recently established
for new technologies or services.
• Multiple codes that are frequently
billed in conjunction with furnishing a
single service.
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• 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 ‘Harvardvalued codes’).
• Other codes determined to be
appropriate by the Secretary.
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
the RVUs with the periodic review
described in section 1848(c)(2)(B) of the
Act. Finally, 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) which
may include consolidation of individual
services into bundled codes for payment
under the physician fee schedule.
b. Progress in Identifying and Reviewing
Potentially Misvalued Codes
Over the last several years, CMS, in
conjunction with the AMA RUC, has
identified and reviewed numerous
potentially misvalued codes in all seven
of the categories 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,
consistent with the new legislative
requirements on this issue. In the
current process, we request the AMA
RUC to review potentially misvalued
codes that we identify and to make
recommendations on revised work
RVUs and/or direct PE inputs for those
codes to us. The AMA RUC, through its
own processes, also might identify and
review potentially misvalued
procedures. We then assess the
recommended revised work RVUs and/
or direct PE inputs and, in accordance
with section 1848(c) of the Act, we
determine if the recommendations
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constitute appropriate adjustments to
the RVUs under the PFS.
Since CY 2009, as a part of the annual
potentially misvalued code review, we
have reviewed over 700 potentially
misvalued codes to refine work RVUs
and direct PE inputs in addition to
continuing the comprehensive FiveYear Review process. We have adopted
appropriate work RVUs and direct PE
inputs for these services as a result of
these reviews.
Our prior reviews of codes under the
potentially misvalued codes initiative
have included codes in all seven
categories specified in section
1848(c)(2)(K)(ii) of the Act. That is, we
have reviewed and assigned more
appropriate values to certain—
• Codes and families of codes for
which there has been the fastest growth;
• Codes and families of codes that
have experienced substantial changes in
practice expenses;
• Codes that were 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 had not been subject
to review since the implementation of
the RBRVS (‘Harvard valued’); and
• Codes potentially misvalued as
determined by the Secretary.
In this last category, we have
previously proposed policies in CYs
2009, 2010, and 2011, and requested
that the AMA RUC review codes for
which there have been shifts in the siteof-service (that is, codes that were
originally valued as being furnished in
the inpatient setting, but that are now
predominantly furnished on an
outpatient basis), as well as codes that
qualify as ‘‘23-hour stay’’ outpatient
services (these services typically have
lengthy hospital outpatient recovery
periods). We note that a more detailed
discussion of the extensive prior
reviews of potentially misvalued codes
is included in the CY 2011 PFS final
rule with comment period (75 FR 73215
through 73216).
In CY 2011, we identified additional
codes under section 1848(c)(2)(K)(ii) of
the Act that we believe are ripe for
review and referred them to the AMA
RUC (75 FR 73215 through 73216).
Specifically, we identified potentially
misvalued codes in the category of
‘‘Other codes determined to be
appropriate by the Secretary,’’ referring
lists of codes that have low work RVUs
but that are high volume based on
claims data, as well as targeted key
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codes that the AMA RUC uses as
reference services for valuing other
services (termed ‘‘multispecialty points
of comparison’’ services).
Since the publication of the CY 2011
PFS final rule with comment period, we
released the Fourth Five-Year Review of
Work (76 FR 32410), which discussed
the identification and review of an
additional 173 potentially misvalued
codes. We initiated the Fourth Five-Year
Review of work RVUs by soliciting
public comments on potentially
misvalued codes for all services
included in the CY 2010 PFS final rule
with comment period that was
published in the Federal Register on
November 25, 2009. In addition to the
codes submitted by the commenters, we
identified a number of potentially
misvalued codes and requested the
AMA RUC review and provide
recommendations. Our identification of
potentially misvalued codes for the
Fourth Five-Year Review focused on
two Affordable Care Act categories: siteof-service anomaly codes and Harvard
valued codes. As discussed in the
Fourth Five-Year Review of Work (76
FR 32410), we sent the AMA RUC an
initial list of 219 codes for review.
Consistent with our past practice, we
requested the AMA RUC to review
codes on a ‘‘family’’ basis rather than in
isolation in order to ensure that
appropriate relativity in the system was
retained. Consequently, the AMA RUC
included additional codes for review,
resulting in a total of 290 codes for the
Fourth Five-Year Review of Work. Of
those 290 codes, 53 were subsequently
sent by the AMA RUC to the CPT
Editorial Panel to consider coding
changes, 14 were not reviewed by the
AMA RUC (and subsequently not
reviewed by us) because the specialty
society that had originally requested the
review in its public comments on the
CY 2010 PFS final rule with comment
period elected to withdraw the codes,
36 were not reviewed by the AMA RUC
because their values were set as interim
final in the CY 2011 PFS final rule with
comment period, and 14 were not
reviewed by us because they were
noncovered services under Medicare.
Therefore, the AMA RUC reviewed 173
of the 290 codes initially identified for
the Fourth Five-Year Review of Work,
and provided the recommendations that
were addressed in detail in the Fourth
Five-Year Review of Work (76 FR
32410). In addition, under the Fourth
Five-Year Review of Work, we reviewed
recommendations for five additional
potentially misvalued codes from the
Health Care Professionals Advisory
Committee (HCPAC), a deliberative
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body of nonphysician practitioners that
also convenes during the AMA RUC
meeting. The HCPAC represents
physician assistants, chiropractors,
nurses, occupational therapists,
optometrists, physical therapists,
podiatrists, psychologists, audiologists,
speech pathologists, social workers, and
registered dieticians.
In summary, since CY 2009, CMS and
the AMA RUC have addressed a number
of potentially misvalued codes. For CY
2009, the AMA RUC recommended
revised work values and/or PE inputs
for 204 misvalued services (73 FR
69883). For CY 2010, an additional 113
codes were identified as misvalued and
the AMA RUC provided us new
recommendations for revised work
RVUs and/or PE inputs for these codes
to us as discussed in the CY 2010 PFS
final rule with comment period (74 FR
61778). For CY 2011, CMS reviewed and
adopted more appropriate values for 209
codes under the annual review of
potentially misvalued codes. For CY
2012, we recently released the Fourth
Five-Year Review of Work, which
discussed the review of 173 potentially
misvalued codes and proposed
appropriate adjustments to RVUs. In
section II.B.5.of this final rule with
comment period, we also provide a list
of codes identified for future
consideration as part of the potentially
misvalued codes initiative, that is, in
addition to the codes that are part of the
Fourth Five-Year Review of Work, as
discussed in that section, we are
requesting the AMA RUC review these
codes and submit recommendations to
us.
c. Validating RVUs of Potentially
Misvalued Codes
In addition to identifying and
reviewing potentially misvalued codes,
section 3134(a) of the Affordable Care
Act added a new section 1848(c)(2)(L) of
the Act, which specifies that the
Secretary shall establish a formal
process to validate RVUs under the PFS.
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 to validate a
sampling of the work RVUs of codes
identified through any of the seven
categories of potentially misvalued
codes specified by 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
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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), we solicited public
comments on possible approaches and
methodologies that we should consider
for a validation process. We received a
number of comments regarding possible
approaches and methodologies for a
validation process. As discussed in the
CY 2011 PFS final rule with comment
period (75 FR 73217), some commenters
were skeptical that there could be viable
alternative methods to the existing AMA
RUC code review process for validating
physician time and intensity that would
preserve the appropriate relativity of
specific physician’s services under the
current payment system. These
commenters generally urged us to rely
solely on the AMA RUC to provide
valuations for services under the PFS.
While a number of commenters
strongly opposed our plans to develop
a formal validation process, many other
commenters expressed support for the
development and establishment of a
system-wide validation process of the
work RVUs under the PFS. As noted in
the CY 2011 PFS final rule with
comment period (75 FR 73217 through
73218), these commenters commended
us for seeking new approaches to
validation, as well as being open to
suggestions from the public on this
process. A number of commenters
submitted technical advice and offered
their time and expertise as resources for
us to draw upon in any examination of
possible approaches to developing a
formal validation process.
However, in response to our
solicitation of comments regarding time
and motion studies, a number of
commenters opposed the approach of
using time and motion studies to
validate estimates of physician time and
intensity, stating that properly
conducted time and motion studies are
extraordinarily expensive and, given the
thousands of codes paid under the PFS,
it would be unlikely that all codes could
be studied. As we stated in the CY 2011
PFS final rule with comment period (75
FR 73218), we understand that these
studies would require significant
resources and we remain open to
suggestions for other approaches to
developing a formal validation process.
We noted that MedPAC suggested in its
comment letter that we should consider
‘‘collecting data on a recurring basis
from a cohort of practices and other
facilities where physicians and
nonphysician clinical practitioners
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work’’ (75 FR 73218). As we stated
previously, we intend to establish a
more extensive validation process of
RVUs in the future in accordance with
the requirements of section 1848(c)(2)(L)
of the Act.
While we received a modest number
of comments specifically addressing
technical and methodological aspects of
developing a validation system, we
believe it would be beneficial to provide
an additional opportunity for
stakeholders to submit comments on
data sources and possible
methodologies for developing a systemwide validation system. In the proposed
rule, we solicited comments on data
sources and studies which may be used
to validate estimates of physician time
and intensity that could be factored into
the work RVUs, especially for services
with rapid growth in Medicare
expenditures, which is one of the
Affordable Care Act categories that the
statute specifically directs us to
examine. We also solicited comments
regarding MedPAC’s suggestion of
‘‘collecting data on a recurring basis
from a cohort of practices and other
facilities where physicians and
nonphysician clinical practitioners
work.’’ We note that after our proposed
rule was released, MedPAC further
discussed its continuing concerns
regarding accurate data. ‘‘In our June
2011 Report to the Congress, we
expressed deep concern in particular
about the accuracy of the fee schedule’s
time estimates––estimates of the time
that physicians and other health
professionals spend furnishing services.
These estimates are an important factor
in determining the RVUs for practitioner
work. However, research for CMS and
for the Assistant Secretary for Planning
and Evaluation has shown that the time
estimates are likely too high for some
services. In addition, anecdotal
evidence and the experience of
clinicians on the Commission raises
questions about the time estimates’’
(MedPAC Report to the Congress
‘‘Medicare and the Health Care Delivery
System, June 2011’’).
We plan to discuss the validation
process in more detail in a future PFS
rule once we have considered the matter
further in conjunction with the public
comments received on the CY 2011
rulemaking, as well as comments
received on this final rule with
comment period. We note that any
proposals we would make on the formal
validation process would be subject to
public comment, and we would
consider those comments before
finalizing the policies.
Comment: We received a number of
comments and suggestions on
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developing a system-wide validation
process, including stakeholders’
reactions to MedPAC’s suggestion of
data collection from a cohort of
physician practices.
Response: We thank the commenters
for their suggestions on developing a
system-wide validation system and, as
we noted previously, we plan to discuss
the development of the validation
process in more detail in a future PFS
rule.
3. Consolidating Reviews of Potentially
Misvalued Codes
As previously discussed, we are
statutorily required under section
1848(c)(2)(B) of the Act to review the
RVUs of services paid under the PFS no
less often than every 5 years. In the past,
we have satisfied this requirement by
conducting separate periodic reviews of
work, PE, and malpractice RVUs for
established services every 5-years in
what is commonly known as CMS’ FiveYear Reviews of Work, PE, and
Malpractice RVUs. On May 24, 2011, we
released the proposed notice regarding
the Fourth Five-Year Review of Work
RVUs. The most recent comprehensive
Five-Year Review of PE RVUs occurred
for CY 2010; the same year we began
using the Physician Practice Information
Survey (PPIS) data to update the PE
RVUs. The last Five-Year Review of
Malpractice RVUs also occurred for CY
2010. These Five-Year Reviews have
historically included codes identified
and nominated by the public for review,
as well as those identified by CMS and
the AMA RUC.
In addition to the Five-Year Reviews,
beginning for CY 2009, CMS and the
AMA RUC have identified and reviewed
a number of potentially misvalued
codes on an annual basis using various
identification screens, such as codes
with high growth rates, codes that are
frequently billed together in one
encounter, and codes that are valued as
inpatient services but that are now
predominately furnished as outpatient
services. These annual reviews have not
included codes identified by the public
as potentially misvalued since,
historically, the public has the
opportunity to submit potentially
misvalued codes during the Five-Year
Review process.
With the enactment of the Affordable
Care Act in 2010, which endorsed our
initiative to identify and review
potentially misvalued codes and
emphasized the importance of our
ongoing work in this area to improve
accuracy and appropriateness of
payments under the PFS, we believe
that continuing the annual
identification and review of potentially
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73055
misvalued codes is necessary. Given
that we are engaging in extensive
reviews of work RVUs and direct PE
inputs of potentially misvalued codes
on an annual basis, we believe that
separate and ‘‘freestanding’’ Five-Year
Reviews of Work and PE may have
become redundant with our annual
efforts. Therefore, for CY 2012 and
forward, we proposed to consolidate the
formal Five-Year Review of Work and
PE with the annual review of potentially
misvalued codes. That is, we would
begin meeting the statutory requirement
to review work and PE RVUs for
potentially misvalued codes at least
once every 5-years through an annual
process, rather than once every 5-years.
Furthermore, to allow for public input
and to preserve the public’s ability to
identify and nominate potentially
misvalued codes for review, we
proposed a process by which the public
could submit codes for our potential
review, along with supporting
documentation, on an annual basis. Our
review of these codes would be
incorporated into our potentially
misvalued codes initiative. This
proposed public process is further
discussed in section II.B.4. of this final
rule with comment period. In the CY
2012 proposed rule, we solicited
comments on our proposal to
consolidate the formal Five-Year
Reviews of Work and PE with the
annual review of potentially misvalued
codes.
Comment: Commenters
overwhelmingly supported the proposal
to consolidate review of potentially
misvalued codes into one annual
process. Commenters also agreed that
the review should include both work
and practice expense, and encouraged
CMS to continue its efforts to ensure
that professional liability valuations are
as current as possible. However, some
commenters were concerned that the
number of codes that CMS and the
public, through the proposed code
nomination process, could potentially
bring forward for review would create
significant burden on specialty societies
in terms of time, manpower, and
financial resources on specialty
societies. The commenters urged CMS
to recognize that a reasonable timeline
is required for specialty societies to
conduct a credible evaluation of
potentially misvalued services,
especially as specialty societies already
have a sizable number of pending
requests for reviews of services
previously identified under the
potentially misvalued code initiative.
To alleviate concerns that the
consolidation could result in requiring
specialty societies to survey a large
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volume of codes every year, commenters
offered several suggestions for limiting
the number of codes reviewed each
year. Commenters requested that CMS
consider establishing a timeframe under
which codes could be resurveyed. That
is, a number of commenters suggested
that the physician work of a code
should not be re-reviewed within a
certain timeframe, such as a 3- or 5-year
period after it was last reviewed.
Commenters also asked that CMS
consider a ‘‘cap’’ on the number of
codes and/or code families that we
would require any given specialty to
review in a calendar year. Furthermore,
some commenters were worried that in
substituting an annual review process
for one that previously occurred once
every five years, the burden of
reviewing codes identified as
potentially misvalued would be
distributed inequitably among the
various specialties, leading to a
perception of unfairness in the process
which the commenters believed would
undermine CMS’ potentially misvalued
codes initiative. These commenters
urged CMS to establish a 3-year
timetable for the review of potentially
misvalued services where a comparable
proportion of codes for each specialty
each year would be specified in advance
so that the specialty societies may be
able to allocate resources more
predictably and efficiently.
Commenters also expressed concern
that CMS is proposing to review
potentially misvalued codes on the
same time frame as the review of new
and revised codes where CMS has
historically issued interim final values
for these codes in the final rule with
comment period. The commenters
asserted they need to have the
opportunity to review CMS’ response to
AMA RUC recommendations, comment
on CMS’ proposed values, and receive a
response from CMS to these comments
prior to January 1 of the year the revised
RVUs will be used to pay physician
claims. A commenter noted ‘‘physicians
should not be penalized by having to
receive potentially incorrect
reimbursement for a procedure for as
much as 12 months because of the
government’s timing of its notice and
comment processes.’’ Other
commenters, while supportive of CMS’
proposal to consolidate reviews,
stressed that the process should not be
condensed so much that there is not
time for thoughtful comment and
consideration. Consequently,
commenters urged CMS to work with
the AMA RUC so that all
recommendations for a given year are
received by an earlier deadline,
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allowing for publication in that year’s
proposed rule and for comments to be
addressed by CMS in that year’s final
rule before changes that affect payment
are implemented.
Response: We appreciate the support
commenters expressed for our proposed
consolidated annual review of codes
and thank the commenters for their
comments and suggestions. We
understand the commenters’ concerns
regarding the potential burden that
some specialty societies may be
expecting from this process. We agree
with commenters that a reasonable
timeline should be allowed for
evaluation of services. Therefore, to
address commenters’ concern regarding
the potential burden, we will be
sensitive to the number of codes
identified as potentially misvalued for
any given specialty society, and we will
prioritize codes for immediate review if
the specialty society makes such a
request to us. Since we cannot predict
with certainty the number of codes that
will be identified as potentially
misvalued, nor the distribution of those
codes among specialty societies for
review, we do not believe we should
predetermine ‘‘caps’’ or place time
limitations on the review process that
may unintentionally hinder the rapid
progress of our potentially misvalued
codes initiative. However, we may
revisit the commenters’ suggestions at a
later date if the volume of codes to be
reviewed becomes an issue.
To respond to the commenters who
were worried that codes identified
through the potentially misvalued codes
process may not be equitably or ‘‘fairly’’
distributed among specialty societies
and have suggested that CMS review a
comparable proportion of codes for each
specialty each year, we note that, based
on our previous experience, the
objective screens we have used to
identify potentially misvalued codes do
not produce lists of codes that are
evenly distributed among the specialties
that furnish them. Rather, the screens
have tended to identify certain types of
services more frequently than others (for
example, due to rapidly changing
technology) and therefore yield
disproportionate numbers of potentially
misvalued codes to be reviewed by the
various specialty societies. However, we
have received similar comments in
previous rules regarding distribution
among specialty societies.
Consequently, in the CY 2012 proposed
rule, we explicitly identified a list of
potentially misvalued high expenditure
codes that spans most specialties
discussed in II.B.5.a. of this final rule
with comment period.
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Finally, to respond to the comments
regarding the code review cycle, we
note that the timing of CMS’ current
review process is constrained by the
CPT Editorial Panel’s scheduled release
of new and revised codes by October 1
and the receipt of the complete AMA
RUC’s recommendations later in the
year, which are at odds with the PFS
rulemaking cycle. As we have indicated
for many years in our PFS final rules
with comment period, most recently in
the CY 2011 rule (75 FR 73170), before
adopting interim RVUs for new and
revised codes, we have the opportunity
to review and consider AMA RUC
recommendations which are based on
input from the medical community. If
we did not adopt RVUs for new and
revised codes in the initial year on an
interim final basis, we would either
have to delay using the codes for a year
or permit each Medicare contractor to
establish their own payment rate for the
codes. 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 before
adopting the values, and the alternatives
could produce undesirable levels of
uncertainty and inconsistency in
payment for a year. We understand the
preference of some commenters for the
review of potentially misvalued codes to
be conducted within a single
rulemaking year in order to avoid
payment under interim values for the
coming year. However, we continue to
believe that it is important to
consolidate the work and PE reviews for
all codes (new, revised, and potentially
misvalued) into one cycle. As we have
explained in several previous PFS final
rules with comment period, most
recently in the CY 2011 PFS final rule
with comment period (75 FR 73170), we
believe it is in the public interest to
adopt interim final revised RVUs for
codes that have been identified as
misvalued. Similar to the new and
revised codes, before making any
changes to RVUs for potentially
misvalued codes, we have an
opportunity to review input from the
medical community in the form of the
AMA RUC recommendations for the
codes. We believe a delay in
implementing revised values for codes
that have been identified as misvalued
would perpetuate payment for the
services at a rate that does not
appropriately reflect the relative
resources involved in furnishing the
service and would continue
unwarranted distortion in the payment
for other services across the PFS.
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We note that it is often difficult to
draw definitive lines between the codes
that are being reviewed as new, revised,
or potentially misvalued. For example,
CMS may identify a code as potentially
misvalued in a given year and refer the
family of codes to the AMA RUC for
review. Subsequently, the AMA RUC
may send the family of codes to the CPT
Editorial Panel for revision because
upon an initial review, the AMA RUC
may have concluded that the family of
services has evolved to the point that
the code descriptors are no longer
appropriate. The CPT Editorial Panel
may revise the code(s) descriptors or
may create entirely new codes to better
define the service. In this final rule with
comment period, we reviewed several
new codes initially referred to the AMA
RUC for review through our potentially
misvalued codes initiative, and we
believe that this trend likely will
increase in the near future.
Additionally, since CMS reviews and
assigns interim values to new and
revised codes in the PFS final rule with
comment period for the coming year,
consolidating the review of potentially
misvalued codes with the new and
revised codes is a more efficient and
transparent process, and reduces the
burden on both specialty societies and
other stakeholders who would
otherwise be called upon to consider,
review and comment on the same family
of codes in multiple rules. Moreover,
consolidation of our review of new,
revised, and potentially misvalued
codes in one cycle allows for codes in
a family to be reviewed together,
resulting in more consistent valuation
within code families and a better
opportunity to maintain appropriate
relativity within code families which, as
we discuss in this section of this final
rule with comment period, is a high
priority.
Therefore, given the considerable
overall support commenters expressed,
we are finalizing our proposal without
modification to consolidate periodic
reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and of
potentially misvalued codes under
section 1848(c)(2)(K) of the Act into one
annual process.
We note that while we proposed to
review the physician work RVUs and
direct PE inputs of potentially
misvalued codes on an annual basis, we
did not propose at this time to review
malpractice RVUs on an annual basis.
As discussed in section II.C. of this final
rule with comment period, in general,
malpractice RVUs are based on
malpractice insurance premium data on
a specialty level. The last
comprehensive review and update of
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the malpractice RVUs occurred for CY
2010 using data obtained from the PPIS
data. Since it is not feasible to conduct
such extensive physician surveys to
obtain updated specialty level
malpractice insurance premium data on
an annual basis, we believe the
comprehensive review of malpractice
RVUs should continue to occur at 5-year
intervals.
Furthermore, in identifying and
reviewing potentially misvalued codes
on an annual basis, we note that this
new proposed process presents us with
the opportunity to review
simultaneously both the work RVUs and
the direct PE inputs for each code.
Heretofore, the work RVUs and direct
PE inputs of potentially misvalued
codes were commonly reviewed
separately and at different times. For
example, a code may have been
identified as potentially misvalued
based solely on its work RVUs so the
AMA RUC would have reviewed the
code and provided us with
recommendations on the physician
times and work RVUs. However, the
direct PE inputs of the code would not
necessarily have been reviewed
concurrently and therefore, the AMA
RUC would not necessarily have
provided us with recommendations for
any changes in the direct PE inputs of
the code that would have been
warranted to ensure that the PE RVUs of
the code are determined more
appropriately. Therefore, while this
code may have been recently reviewed
and revised under the potentially
misvalued codes initiative for physician
work, the PE component of the code
could still be potentially misvalued.
Going forward, we believe combining
the reviews of both physician work and
PE for each code under our potentially
misvalued codes initiative will align the
review of these codes and lead to more
accurate and appropriate payments
under the PFS.
Finally, it is important to note that the
code-specific resource based relative
value framework under the PFS system
is one in which services are ranked
relative to each other. That is, the work
RVUs assigned to a code are based on
the physician time and intensity
expended on that particular service as
compared to the physician time and
intensity of the other services paid
under the PFS. This concept of relativity
to other services also applies to the PE
RVUs, particularly when it comes to
reviewing and assigning correct direct
PE inputs that are relative to other
similar services. Consequently, we are
emphasizing the need to review both the
work and PE components of codes that
are identified as part of the potentially
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73057
misvalued initiative to ensure that
appropriate relativity is constructed and
maintained in several key relationships:
• The work and PE RVUs of codes are
ranked appropriately within the code
family. That is, the RVUs of services
within a family should be ranked
progressively so that less intensive
services and/or services that require less
physician time and/or require fewer or
less expensive direct PE inputs should
be assigned lower work or PE RVUs
relative to other codes within the
family. For example, if a code for
treatment of elbow fracture is under
review under the potentially misvalued
codes initiative, we would expect the
work and PE RVUs for all the codes in
the family also be reviewed in order to
ensure that relativity is appropriately
constructed and maintained within this
family. Furthermore, as we noted in the
CY 2010 PFS final rule with comment
period (74 FR 61941), when we submit
codes to the AMA RUC and request its
review, in order to maintain relativity,
we emphasized the importance of
reviewing the base code of a family. The
base code is the most important code to
review because it is the basis for the
valuation of other codes within the
family and allows for all related codes
to be reviewed at the same time (74 FR
61941).
• The work and PE RVUs of codes are
appropriately relative based on a
comparison of physician time and/or
intensity and/or direct inputs to other
services furnished by physicians in the
same specialty. To continue the
example discussed previously, if a code
for treatment of elbow fracture is under
review, we would expect this code to be
compared to other codes, such as codes
for treatment of humerus fracture, or
other codes furnished by physicians in
the same specialty, in order to ensure
that the work and PE RVUs are
appropriately relative within the
specialty.
• The work and PE RVUs of codes are
appropriately relative when compared
to services across specialties. While it
may be challenging to compare codes
that describe completely unrelated
services, since the entire PFS is a budget
neutral system where payment
differentials are dependent on the
relative differences between services, it
is essential that services across
specialties are appropriately valued
relative to each other. To illustrate the
point, if a service furnished primarily by
dermatology is analogous in physician
time and intensity to another service
furnished primarily by allergy/
immunology, then we would expect the
work RVUs for the two services to be
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similar, even though the two services
may be otherwise unrelated.
4. Public Nomination Process
Under the previous Five-Year
Reviews, the public was provided with
the opportunity to nominate potentially
misvalued codes for review. To allow
for public input and to preserve the
public’s ability to identify and nominate
potentially misvalued codes for review
under our annual potentially misvalued
codes initiative, we proposed a process
by which on an annual basis the public
could submit codes, along with
documentation supporting the need for
review. We proposed that stakeholders
may nominate potentially misvalued
codes 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. We
would evaluate the supporting
documentation and decide whether the
nominated code should be reviewed as
potentially misvalued during the
following year. If we were to receive an
overwhelming number of nominated
codes that qualified as potentially
misvalued in any given year, we would
prioritize the codes for review and
could decide to hold our review of some
of the potentially misvalued codes for a
future year. We noted that we may
identify additional potentially
misvalued codes for review by the AMA
RUC based on the seven statutory
categories under section
1848(c)(2)(K)(ii) of the Act.
We encouraged stakeholders who
believe they have identified a
potentially misvalued code, supported
by documentation, to nominate codes
through the public process. We
emphasized that in order to ensure that
a nominated code will be fully
considered to qualify as a potentially
misvalued code to be reviewed under
our annual process, accompanying
documentation must be provided to
show evidence of the code’s
inappropriate valuation, either in terms
of inappropriate physician times, work
RVUs, and/or direct PE inputs. The
AMA RUC developed certain
‘‘Guidelines for Compelling Evidence’’
for the Third Five-Year Review which
we believe could be applicable for
members of the public as they gather
supporting documentation for codes
they wish to nominate for the annual
review of potentially misvalued codes.
The specific documentation that we
would seek under this proposal
includes the following:
• Documentation in the peer
reviewed medical literature or other
reliable data that there have been
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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.
++ Physician time.
• An anomalous relationship between
the code being proposed for review and
other codes. For example, if code ‘‘A’’
describes a service that requires more
work than codes ‘‘B,’’ ‘‘C,’’ and ‘‘D,’’ but
is nevertheless valued lower. The
commenter would need to assemble
evidence on service time, technical
skill, patient severity, complexity,
length of stay and other factors for the
code being considered and the codes to
which it is compared. These reference
services may be both inter- and intraspecialty.
• Evidence that technology has
changed physician work, that is,
diffusion of technology.
• Analysis of other data on time and
effort measures, such as operating room
logs or national and other representative
databases.
• Evidence that incorrect
assumptions were made in the previous
valuation of the service, such as a
misleading vignette, survey, or flawed
crosswalk assumptions in a previous
evaluation;
• Prices for certain high cost supplies
or other direct PE inputs that are used
to determine PE RVUs are inaccurate
and do not reflect current information.
• Analyses of physician 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), and the Physician
Quality Reporting System (PQRS)
databases).
• National surveys of physician time
and intensity from professional and
management societies and
organizations, such as hospital
associations.
We noted that when a code is
nominated, and supporting
documentation is provided, we would
expect to receive a description of the
reasons for the code’s misvaluation with
the submitted materials. That is, we
would require a description and
summary of the evidence is required
that shows how the service may have
changed since the original valuation or
may have been inappropriately valued
due to an incorrect assumption. We
would also appreciate specific Federal
Register citations, if they exist, where
commenters believe the nominated
codes were previously valued
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erroneously. We also proposed to
consider only nominations of active
codes that are covered by Medicare at
the time of the nomination.
As proposed in the CY 2012 proposed
rule, after we receive the nominated
codes during the 60-day comment
period following the release of the
annual PFS final rule with comment
period, we would review the supporting
documentation and assess whether they
appear to be potentially misvalued
codes appropriate for review under the
annual process. We proposed that, in
the following PFS proposed rule, we
would publish a list of the codes
received under the public nomination
process during the previous year and
indicate whether the codes would be
included in the current review of
potentially misvalued codes. We would
also indicate the publicly nominated
codes that we would not be including in
the current review (whether due to
insufficient documentation or for other
reasons). Under this proposed process,
the first opportunity for the public to
nominate codes would be during the
public comment period for this CY 2012
PFS final rule with comment period. We
would publish in the CY 2013 PFS
proposed rule, the list of nominated
codes, and indicate whether they will be
reviewed as potentially misvalued
codes. We would request that the AMA
RUC review these potentially misvalued
codes along with any other codes
identified by CMS as potentially
misvalued, and provide to us
recommendations for appropriate
physician times, work RVUs, and direct
PE inputs. We requested public
comments on this proposed code
nomination process and indicated that
we would consider any suggestions to
modify and improve the proposed
process.
Comment: The vast majority of
commenters supported CMS’ proposal
to develop a public nomination process
for potentially misvalued codes. The
commenters noted that the proposed
process would provide a way for the
public to participate in the
identification of potentially misvalued
procedures. Commenters were
enthusiastic that the proposal allows for
stakeholders to propose a code for
review on an immediate basis which is
a significant improvement to the current
process, noting that previously, only
‘‘CMS and the RUC could bring a code
forward for review whenever they have
reason to believe it may be misvalued;
however, physicians, other healthcare
providers, specialty societies and other
stakeholders are restricted to a five-year
cycle.’’ On the other hand, another
commenter ‘‘does not agree with the
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once-a-year opportunity to nominate
codes [and] * * * recommends that
there should be greater opportunity for
public comment.’’
A number of commenters stated that
they believe the supporting
documentation criteria would ensure
that all requests are considered fairly
and urged CMS to conduct a rigorous
review of public comments and
supporting documentation when
determining whether a publicly
nominated code should be reviewed as
a potentially misvalued code, especially
when a code is nominated by only a few
commenters or even a single
commenter. Other commenters thought
CMS should provide ‘‘guidelines’’ to
justify bringing a code(s) forward for
review in order to prevent a member of
the public from asking that every single
code paid under the Medicare PFS be
reviewed. Some commenters noted that
‘‘professional associations participating
on the RUC frequently struggle with the
concept and documentation of
‘Compelling Evidence.’ ’’ Consequently,
the commenters believed that the public
will likewise struggle with the concept
of submitting evidence to substantiate
potentially misvalued codes. Other
commenters noted that the public
nomination process proposed by CMS
requires that commenters nominating
codes include supportive evidence to
show that the resource use related to the
delivery of a service has changed in a
way to suggest a code’s RVUs may be
misvalued, whereas CMS is not
obligated to follow this same standard.
The commenters suggested that CMS
should be required to adhere to the
supporting documentation that the
public would need to provide when
nominating a potentially misvalued
code for review through the proposed
public nomination process.
Several commenters believed that
CMS should not restrict which codes
could be nominated or referred. A
number of commenters objected to CMS’
proposal to consider only nominations
of active codes that are covered by
Medicare at the time of the nomination.
The commenters believed this proposal
was unfair to those specialties that do
not serve a predominantly Medicareaged population but who must also rely
on the the resource based relative value
scale. The commenters asserted that
CMS has historically published the
relative value recommendations from
the AMA RUC for preventive services
and other non-covered services.
Commenters recommended that all
valid CPT codes should remain open to
comment and review. Commenters also
believed as long as a stakeholder could
provide adequate supporting
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documentation to support the
nomination of the code, CMS should
allow for the review of any code,
including any codes that went through
refinement in the past.
Commenters also expressed
appreciation that CMS proposed to
disclose in the PFS proposed rule the
list of codes identified as potentially
misvalued (including those that
originated from the public nomination
process) for future review because
publishing the misvalued codes list
provides some notice to affected parties
who may wish to provide input during
the review process. Some commenters
suggested that following the nomination
process, specialty societies should have
another opportunity to review and
comment on any relevant nominations
before CMS decides to include the codes
on the list of potentially misvalued
codes in the proposed rule.
Response: We appreciate the
enthusiasm expressed by commenters
who welcome the opportunity to
participate with us in the identification
of potentially misvalued codes. We also
acknowledge the commenters’ concern
that our requirements for accompanying
documentation to show how the code is
potentially misvalued may be viewed as
burdensome and could pose a barrier to
the public in nominating some codes.
We provided guidelines in the proposed
rule for such documentation in order to
help the public to develop a strong case
and assemble sufficient documentation
when nominating a code. Although
some commenters viewed the
requirement to provide evidence of
potential misvaluation as overly
burdensome, it is important to
demonstrate that a nominated code is
not only potentially misvalued, but that
improved accuracy in payment for the
code would improve the overall
accuracy of the physician fee schedule.
As commenters have pointed out,
reviewing potentially misvalued codes
is resource intensive for the AMA RUC,
specialty societies, CMS, and the public,
and we must ensure that codes we refer
as potentially misvalued warrant the
requested review.
However, to respond to the
commenters who suggested we should
be required to follow the same process
as the public for nominating potentially
misvalued codes, we note that we have
longstanding statutory authority to
identify and review the RVUs of
services no less often than every 5-years
and that we frequently have exercised
our discretion to prioritize codes for
review.
We understand commenters’ concerns
about the burden that reviewing codes
entails. We believe that by ranking
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codes in order of interest to CMS for
review over a reasonable timeframe, we
can help to reduce some of that burden.
For this year, we have prioritized the
review of codes to those that have some
degree of significant financial impact on
the PFS. Specifically, we have proposed
a list of high expenditure codes for
review in CY 2012. 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. We note
that while we have published the AMA
RUC relative value recommendations for
non-covered services as a courtesy,
these codes historically have not been
reviewed by CMS and the RVUs are not
valid for Medicare payment purposes.
Therefore, while we will continue our
historical practice of publishing the
AMA RUC relative value
recommendations for non-covered
services, we will not be accepting for
review either inactive or non-covered
codes (for which the RVUs will have no
financial impact on the PFS) through
the public nomination process. We will
consider any other active and Medicare
covered services that are nominated by
the public and supported by
documentation of the nature described
previously in this section.
Finally, we note that all timely
comments received on the final rule
with comment period can be accessed
and reviewed by the public through
https://www.regulations.gov/ after the
final rule’s comment period closes.
Therefore, anyone who wishes to look
though the public comments can
identify the codes that have been
nominated by the public as potentially
misvalued, as well as the accompanying
supporting documentation. CMS will
assess the list of publicly nominated
codes, taking into consideration the
documentation provided as well as the
list of codes the agency has identified
for review, and will identify and
publish in the following year’s proposed
rule the list of nominated codes and
codes selected for review. Accordingly,
we are finalizing the proposed public
nomination process without
modification.
5. CY 2012 Identification and Review of
Potentially Misvalued Services
a. Code Lists
While we anticipate receiving
nominations from the public for
potentially misvalued codes in
conjunction with rulemaking, we
believe it is imperative that we continue
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the work of the review initiatives over
the last several years and drive the
agenda forward to identify, review, and
adjust values for potentially misvalued
codes for CY 2012.
In the CY 2011 PFS proposed rule (75
FR 40068 through 40069), we identified
and referred to the AMA RUC a list of
potentially misvalued codes in three
areas:
• Codes on the AMA RUC’s multispecialty points of comparison (MPC)
list (used as reference codes in the
valuation of other codes),
• Services with low work RVUs that
are billed in multiples (a statutory
category); and
• Codes that have low work RVUs for
which CMS claims data show high
volume (that is, high utilization of these
codes represents a significant dollar
impact in the payment system).
Our understanding is that the AMA
RUC is currently working towards
reviewing these codes at our request.
We intend to provide an update and
discuss any RVU adjustments to codes
that have been identified as potentially
misvalued in the CY 2012 PFS final
rule, as they move through the review
process.
Meanwhile, for CY 2012, we are
continuing with our work to identify
and review additional services under
the potentially misvalued codes
initiative. Stakeholders have noted that
many of the services previously
identified under the potentially
misvalued codes initiative were
concentrated in certain specialties. To
develop a robust and representative list
of codes for review under the
potentially misvalued codes initiative,
we examined the highest PFS
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expenditure services by specialty (based
on our most recently available claims
data and using the specialty categories
listed in the PFS specialty impact table,
see Table 84 in section IX.B. of this final
rule with comment period) and
identified those that have not been
reviewed since CY 2006 (which was the
year we completed the Third Five-Year
Review of Work and before we began
our potentially misvalued codes
initiative).
In our examination of the highest PFS
expenditure codes for each specialty
(we used the specialty categories listed
in the PFS specialty impact table, see
Table 84 in section IX.B. of this final
rule with comment period), we noted
that Evaluation and Management (E/M)
services consistently appeared in the
top 20 high PFS expenditure services.
We noted as well that most of the E/M
services have not been reviewed since
the comprehensive review of services
for the Third Five-Year Review of Work
in CY 2006. Therefore, after an
examination of the highest PFS
expenditure codes for each specialty, we
have developed two code lists of
potentially misvalued codes which we
proposed to refer to the AMA RUC for
review.
First, we proposed to request that the
AMA RUC conduct a comprehensive
review of all E/M codes, including the
codes listed in Table 6. As shown
previously, E/M services are commonly
among the highest PFS expenditure
services. Additionally in recent years,
there has been significant interest in
delivery system reforms, such as
patient-centered medical homes and
making the primary care physician the
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focus of managing the patient’s chronic
conditions. The chronic conditions
challenging the Medicare population
include heart disease, diabetes,
respiratory disease, breast cancer,
allergy, Alzheimer’s disease, and factors
associated with obesity. Thus, as the
focus of primary care has evolved from
an episodic treatment-based orientation
to a focus on comprehensive patientcentered care management in order to
meet the challenges of preventing and
managing chronic disease, we believed
a more current review of E/M codes was
warranted. We note that although
physicians in primary care specialties
bill a high percentage of their services
using the E/M codes, physicians in nonprimary care specialties also bill these
codes for many of their services.
Since we believe the focus of primary
care is evolving to meet the challenges
of preventing and managing chronic
disease, we noted in the proposed rule
that we would like the AMA RUC to
prioritize review of the E/M codes and
provide us with recommendations on
the physician times, work RVUs, and
direct PE inputs of at least half of the
E/M codes listed in Table 6 by July 2012
in order for us to include any revised
valuations for these codes in the CY
2013 PFS final rule with comment
period. We also noted that we would
expect the AMA RUC to review the
remaining E/M codes listed in Table 6
by July 2013 in order for us to complete
the comprehensive re-evaluation of E/M
services and include the revised
valuations for these codes in the CY
2014 PFS final rule with comment
period.
BILLING CODE 4120–01–P
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BILLING CODE 4120-01-C
Comment: Many commenters did not
believe that reviewing the work RVUs
and direct PE inputs of all E/M services
is warranted at this time. A significant
number of commenters generally agreed
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that health care delivery has changed,
that chronic disease management has
led to increases in physician time and
effort, and that primary care physicians
provide valuable services to Medicare
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beneficiaries that are not captured
appropriately in the E/M services. Some
commenters did not believe that the
resource-based relative value scale is the
appropriate system to account for
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changes in health care delivery models.
A smaller number of commenters did
not believe that physician work for E/M
services had changed since the codes
were last reviewed.
The majority of commenters requested
that CMS withdraw its proposal to
review all E/M codes because the
current E/M codes, as written, do not
fully encompass the work associated
with patient-centered care management.
The commenters noted that there are
many codes that have been reviewed
and valued by the AMA RUC for such
services, including medical team
conference, comprehensive preventive
evaluation, physician supervision of a
hospice patient, international
normalized ratio management, smoking
and alcohol counseling, case
management, monthly medical home
management, anticoagulation
management, and phone or electronic
evaluation. Some commenters noted
that the AMA RUC has previously
provided recommendations to value
telephone and electronic evaluation
services that complement coordinated
care. While Medicare either does not
pay separately for or does not cover
many of these services, the commenters
believed these services are part of a
patient centered care management
model and are necessary services for
managing patients with chronic
conditions. The commenters urged CMS
to provide explicit payment for these
coordination services rather than
attempt to address the primary care
issue through the comprehensive review
of current E/M code values. For
example, commenters suggested CMS
‘‘work with the medical community to
develop and implement the patientcentered medical home, reward
prevention and wellness, eliminate
fragmentation and duplication, and
produce a cohesive system of care that
prevents unnecessary complications
from acute or chronic illness,
hospitalizations, and other avoidable
expenses.’’
Some commenters asserted that the
current E/M codes have code
descriptors and documentation
requirements that do not capture the
work necessary for chronic disease
management. Commenters noted that
the current E/M codes were developed
20 years ago and describe care of
patients with acute problems. In
addition, the commenters believed the
current E/M codes do not describe care
to treat chronic medical problems of
patients in skilled nursing facilities
which were treated in the hospital a few
years ago. Commenters asserted that
physicians are now caring for an
increasingly complex elderly population
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with multiple chronic problems who
require services such as extensive care
coordination that was not part of
standard medical practice when many
of the E/M codes were created. Thus,
while the commenters agreed that care
coordination would help better manage
chronic diseases in the elderly, they
believed this care would be better
described by new codes, and not the
current E/M codes. Accordingly, the
commenters recommended that CMS
undertake a comprehensive review of
the existing E/M service codes in
collaboration with the AMA RUC and
the CPT Editorial Panel. That is, the
commenters envisioned and supported
an extensive review that considers
revisions to these codes that will better
recognize the work of primary care
physicians and cognitive specialists
who provide care for patients with acute
and chronic conditions before focusing
on the valuation of the codes.
Many commenters, representing
different medical specialties, noted that
CMS’ focus on primary care as the locus
for care coordination and chronic
disease management is misplaced.
Commenters asserted that patient care
coordination, prevention, performance
measurement and the adoption of health
information technology affects the entire
medical community. These commenters
argued that that these trends and
initiatives will pose challenges for
specialty medicine as well. Specifically,
a commenter stated, ‘‘We believe that
high quality provision of such services
is not defined by the specialty of the
provider and thus we cannot support
policy options that focus on provider
specialty rather than on the content and
the quality of the service being
provided.’’
Other commenters noted that the E/M
codes are used by many surgeons and
other specialists because nearly every
procedural CPT code involves one or
more E/M service within the code’s
global period. Commenters suggested
that CMS unbundle E/M services from
surgical codes in order to ensure that
surgical patients received the
appropriate follow-up care and
management of post-procedure activity
to achieve desired outcomes. That is,
CMS should apply zero-day global
periods to surgical codes, such that
post-operative hospital and office visits
must meet the medical necessity and
documentation requirements for
evaluation and management coding in
order to be paid separately.
Finally, some commenters noted that
the previous comprehensive review of
the evaluation and management codes
in 2006 did not improve the emphasis
on chronic care management, stating
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that ‘‘the third 5-Year Review failed to
achieve the goals of properly
compensating primary physicians for
chronic care management, so there is no
expectation that another review within
the existing system will result in a
different outcome.’’ A few commenters
supported the proposal to review the
E/M codes and they ‘‘consider the
review and re-evaluation of E&M codes
as a critical immediate step to ensure
patient access to care and to
maintaining the viability of the [their]
workforce.’’
Response: We thank the commenters
for their comments on our proposal to
review E/M services and address the
evolving challenges of chronic care
management. We also appreciate
commenters’ support for recognizing the
importance of primary care and care
coordination, and appropriately valuing
such care within Medicare’s statutory
structure for physician payment and
quality reporting. We understand some
commenters’ concerns about the ability
of the current E/M coding and
documentation system to appropriately
value primary care services and
improved care coordination. We
understand that many commenters
would prefer that we consider paying
separately for non-face-to-face care
coordination activities, such as
telephone calls and medical team
conferences, rather than finalize the
proposal to request that the AMA RUC
review all 91 E/M codes at this time. We
will continue to explore valuations of
E/M services and other potential
refinements to the PFS that would
appropriately value these services. We
are also examining many other programs
that may contribute to more appropriate
valuation of services and better health
care outcomes.
We would like to assure the
commenters that we, as well as the
HHS’ Assistant Secretary for Planning
and Evaluation (ASPE), are actively
researching our current coding and
payment systems to appropriately value
these services. As detailed in the
proposed rule (75 FR 42917), we are
considering several approaches to
improve coordinated care and health
care transitions to reduce readmissions
or subsequent illnesses, improve
beneficiary outcomes, and avoid
additional financial burden on the
health care system. We are committed to
achieving better care for individuals,
better health for populations, and
reduced expenditure growth. Reforms
such as Accountable Care Organizations
and Medical Homes and reforms of our
current fee-for-service payment system
are designed to achieve these goals.
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As an example, we recently launched
the Partnership for Patients (in April
2011), a national public-private patient
safety initiative for which more than
6,000 organizations—including
physician and nurses’ organizations,
consumer groups, employers and over
3,000 hospitals—have pledged to help
achieve the Partnership’s goals of
reducing hospital complications and
improving care transitions. The
Partnership for Patients includes the
Community-Based Care Transitions
Program, which provides funding to
community-based organizations
partnering with eligible hospitals to
coordinate a continuum of post-acute
care in order to test models for
improving care transitions for high risk
Medicare beneficiaries. Achieving the
goals of the Partnership for Patients will
take the combined effort of many key
stakeholders across the health care
system—physicians, nurses, hospitals,
health plans, employers and unions,
patients and their advocates, as well as
the Federal and State governments.
Many important stakeholders have
already pledged to join this Partnership
in a shared effort to save thousands of
lives, stop millions of injuries and take
important steps toward a more
dependable and affordable health care
system. We are currently working with
these stakeholders to improve care
processes and systems, enhance
communication and coordination to
reduce complication for patients, raise
public awareness and develop
information, tools and resources to help
patients and families effectively engage
with their providers to avoid
preventable complications, and provide
the incentives and support that will
enable clinicians and hospitals to
deliver high-quality health care to their
patients, with minimal burdens. (For
more information regarding the
Partnership for Patients Initiative, we
refer readers to https://www.healthcare.
gov/compare/partnership-for-patients/
index.html.)
Additionally, the Center for Medicare
and Medicaid Innovation (Innovation
Center) of CMS has undertaken several
demonstrations to support care
coordination and primary care. Most
recently, on September 28, 2011, we
released a request for applications for
the Comprehensive Primary Care
Initiative, a CMS-led multipayer
initiative to provide enhanced support
for comprehensive primary care. A
primary care practice is a key point of
contact for patients’ health care needs.
In recent years, new ways have emerged
to strengthen primary care by improving
care coordination, making it easier to
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work together, and helping clinicians
spend more time with their patients.
Under the Comprehensive Primary Care
Initiative, we intend to pay primary care
providers a monthly care management
fee on behalf of Medicare fee-for-service
beneficiaries and, in participating states,
Medicaid fee-for-service beneficiaries
for improved and comprehensive care
management. Specifically, participating
primary care practices will be given
support to better coordinate primary
care for their Medicare patients,
including creating personalized care
plans for patients with serious or
chronic diseases follow personalized
care plans, give patients 24-hour access
to care and health information, more
preventive care, and more patient
centered care management. The work of
the Comprehensive Primary Care
Initiative could inform and help further
develop innovative revisions to the PFS.
(For more information regarding the
Comprehensive Primary Care Initiative,
we refer readers to https://innovations.
cms.gov/areas-of-focus/seamless-andcoordinated-care-models/cpci/.)
Further, HHS’ ASPE has convened a
Technical Expert Panel (TEP) to conduct
studies that could inform efforts to
accurately align physician payments in
Medicare, which may help expand the
supply of primary care physicians and
improve the value of care for
beneficiaries. One of the major tasks
being undertaken by this TEP is to
develop new approaches to defining
visits and paying for primary care
services under the physician fee
schedule. There are a number of
services that are increasingly viewed as
key to high-quality primary care but that
do not require a face-to-face encounter
with the patient. While the valuations of
current E/M services include care
coordination, communication and other
management, this project will consider
how visits are defined and will examine
whether we need to adjust payments to
appropriately pay for primary care
activities. It makes sense to reassess
how visits are defined because it is
becoming increasingly more common
for primary care physicians to be
engaged in the management of multiple
established chronic conditions rather
than evaluation and treatment of acute,
new problems. The complexity and time
for the physician is more often
associated with decision-making than
with the history-taking and physicals.
Further, the chronic care model
involves much greater attention to
teaching patient self-management skills,
doing more proactive care coordination,
and anticipation of health care needs.
We believe the TEP findings could
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provide us with improved information
for the valuation of primary care
services, including care coordination,
which may be more effective than
simply reviewing the work RVUs and
direct PE inputs of current E/M services.
In addition to ASPE’s efforts that are
focused directly on physician payment,
they also have a second project
underway to research effective methods
for increasing the supply of primary
care providers and services. This project
will analyze what is known about the
relative effectiveness of various
strategies to increase the supply of
primary care providers and services in
order to meet these future health system
needs.
Accordingly, given the significant
concern expressed by the majority of
commenters over the possible
inadequacies of the current E/M coding
and documentation structure to address
evolving chronic care management and
support primary care and our ongoing
research on how to best provide
payment for primary care and patientcentered care management, we are not
finalizing the proposal to review the list
of 91 E/M codes at this time. Instead, we
believe allowing time for consideration
of the findings of the Comprehensive
Primary Care Initiative, the ASPE
research on balancing physician
incentives and evaluating payment for
primary care services, demonstrations
that we have undertaken on care
coordination, as well as other initiatives
assessing how to value and encourage
primary care will provide improved
information for the valuation of chronic
care management, primary care, and
care transitions. We also will continue
to consider the numerous policy
alternatives that commenters offered,
such as separate E/M codes for
established visits for patients with
chronic disease versus a post-surgical
follow-up office visits. We intend to
continue to work with stakeholders on
how to value and pay for primary care
and patient-centered care management,
and we continue to welcome ideas from
the medical community for how to
improve care management through the
provision of primary care services.
Second, we also proposed providing a
select list of high PFS expenditure
procedural codes representing services
furnished by an array of specialties, as
listed in Table 7. These procedural
codes have not been reviewed since CY
2006 (before we began our potentially
misvalued codes initiatives in CY 2008)
and, based on the most recently
available data, have CY 2010 allowed
charges of greater than $10 million at
the specialty level (based on the
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specialty categories listed in the PFS
specialty impact table and CY 2010
Medicare claims data). A number of the
codes in Table 7 would not otherwise be
identified as potentially misvalued
services using the screens we have used
in recent years with the AMA RUC or
based on one of the six specific statutory
categories under section 1848(c)(2)(k)(ii)
of the Act. However, we identified the
potentially misvalued codes listed in
Table 7 under the seventh statutory
category, ‘‘other codes determined to be
appropriate by the Secretary.’’ We
selected these codes based on the fact
that they have not been reviewed for at
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least 6 years, and in many cases the last
review occurred more than 10 years ago.
They represent high Medicare
expenditures under the PFS; thus, we
believe that a review to assess changes
in physician work and update direct PE
inputs is warranted. Furthermore, since
these codes have significant impact on
PFS payment on a specialty level, a
review of the relativity of the codes to
ensure that the work and PE RVUs are
appropriately relative within the
specialty and across specialties, as
discussed previously, is essential. For
these reasons, we have identified these
codes as potentially misvalued and
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proposed to request the AMA RUC
review the codes listed in Table 7 and
provide us with recommendations on
the physician times, work RVUs and
direct PE inputs in a timely manner.
That is, similar to our proposal for the
AMA RUC to review E/M codes in a
timely manner, we proposed to request
that the AMA RUC review at least half
of the procedural codes listed in Table
7 by July 2012 in order for us to include
any revised valuations for these codes in
the CY 2013 PFS final rule with
comment period.
BILLING CODE 4210–01–P
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Comment: Some commenters did not
believe that high expenditure/high
volume was an appropriate criterion for
us to use to identify the codes for the
potentially misvalued codes initiative,
stating ‘‘simply because a service is
frequently performed, does not indicate
that the service may be overvalued.’’
Additionally, the commenters believed
that selecting codes that have not been
reviewed since CY 2006 was arbitrary
and assumes that the delivery of these
services and procedures has changed
radically over the past 5-years. Other
commenters believed CMS should
provide justification for the revaluation
by providing evidence of how the
delivery of a service or procedure has
changed within 5 years.
Some commenters agreed that high
expenditure codes should be reviewed
on a periodic basis; however, the
commenters suggested that the periodic
basis should be a reasonably long length
of time and 5 (or 6) years is not a
sufficiently long period of time absent
other evidence of potential changes in
the service under review. The
commenters suggested that CMS could
automatically review high expenditure
procedures every 10 or 15 years.
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MedPAC, commenting on the CY 2012
PFS proposed rule, agreed that accurate
payments for high expenditure services
‘‘can improve the balance of payments
between primary care and services such
as imaging tests, and other procedures.’’
Finally, we received a number of
comments on specific codes where
commenters provided arguments as to
why CMS should remove these codes
from the high expenditure code list. The
commenters noted that specific codes
had been considered by the AMA RUC
in the past five years or that certain
codes are currently scheduled to be
considered by either the CPT Editorial
Panel for new coding or the AMA RUC
for revised valuations (for work RVUs
and/or PE inputs) at an upcoming
meeting.
Response: As we noted previously, it
is a long-standing statutory requirement
that we review RVUs no less often than
every 5-years and, in conducting these
reviews, we have historically exercised
our discretion to prioritize which codes
to review. In proposing to prioritize this
list of high expenditure codes, we stated
that the reason we identified these
codes is because they have significant
impact on PFS payment on a specialty
level and have not been recently
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reviewed. We believe that the practice
of a service can evolve over time, as can
the technology used to conduct the
service, and such efficiencies could
easily have developed since our last
comprehensive review of services in
2006 for the third 5-year review. As
such, a review of the relativity of these
codes, which are high expenditure and
high volume, to ensure that the work
and PE RVUs are appropriately valued
to reflect changes in practice and
technology and relative to other services
within the specialty and across
specialties is essential to the overall
accuracy of the PFS.
Because of the concerns expressed by
commenters about the burden
associated with code reviews, we
believe that it is appropriate to prioritize
review of codes to a manageable subset
that also have a high impact on the PFS
and work with the specialty society to
spread review of the remaining codes
identified as potentially misvalued over
a reasonable timeframe. In this spirit,
we do not believe it would be
appropriate to remove codes from the
high expenditure list unless we find, as
some commenters indicated, that we
have reviewed both the work RVUs and
direct PE inputs for the code during the
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specified time period. Also, regarding
the suggestion to schedule review of
high expenditure codes every 10 to 15years, not only do we believe more
regular monitoring of codes with high
impact on the PFS will produce a more
accurate and equitable payment system,
but we have a statutory obligation to
review codes at least every 5-years
(although we do not always conduct a
review that involves the AMA RUC). As
noted, changes in technology and
practice evolve for many services more
rapidly than every 10 to 15-years. We
also believe that, with our decision not
to review the 91 E/M codes at this time,
we have relieved some of the burden on
specialty societies, which should enable
them to complete their reviews of these
high expenditure/high volume codes.
Finally, in reviewing the code specific
comments, we noticed that in many
cases, the commenters believed that the
code should be removed from this code
list because the work RVU had been
reviewed within 6-years, or the code
was recently considered at an AMA
RUC meeting. We note that while a
number of codes have been considered
at an AMA RUC meeting, until we
receive recommendations and review
the codes for both work and direct PE
inputs, we will continue to include
these codes on the high expenditure list.
We think some of the commenters may
have believed that since a code was
discussed at an AMA RUC meeting and
sent to the CPT editorial panel or the
code is being surveyed and prepared for
a presentation at the AMA RUC, the
code should be removed from the
potentially misvalued high expenditure
code list. We are clarifying that even if
a code is about to be reviewed by the
specialty society or AMA RUC, or
referred to the CPT Editorial Panel, we
would continue to include the code on
our list of codes for review under the
potentially misvalued codes initiative.
Similarly, if a code is being reviewed by
the CPT editorial panel, we would
consider any replacement codes to
address the potential misvaluation
associated with the previous codes.
Accordingly, we are finalizing the
proposed high expenditure/high volume
list without modification.
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Specific Codes
On an ongoing basis, public
stakeholders (including physician
specialty societies, beneficiaries, and
other members of the public) bring
concerns to us regarding direct PE
inputs and physician work. In the past,
we would consider these concerns and
address them through proposals in
annual rulemaking, technical
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corrections, or by requesting that the
AMA RUC consider the issue.
Since last year’s rulemaking, the
public has brought a series of issues to
our attention that relate directly to
direct PE inputs and physician work.
We believe that some of these issues
will serve as examples of codes that
might be brought forward by the public
as potentially misvalued in the
proposed nomination process as
discussed previously in section II.B.4. of
this final rule with comment period.
(1) Codes Potentially Requiring Updates
to Direct PE Inputs
Abdomen and Pelvis CT. For CY 2011,
AMA CPT created a series of new codes
that describe combined CTs of the
abdomen and pelvis. Prior to 2011,
these services would have been billed
using multiple stand-alone codes for
each body region. The new codes are:
74176 (Computed tomography,
abdomen and pelvis; without contrast
material); 74177 (Computed
tomography, abdomen and pelvis; with
contrast material); and 74178
(Computed tomography, abdomen and
pelvis; without contrast material in one
or both body regions, followed by with
contrast material(s) and further sections
in one or both body regions.)
As stated in the CY 2011 PFS final
rule with comment period (75 FR
73350), we accepted the AMA RUCrecommended direct PE inputs for these
codes, with refinements to the
equipment minutes to assure that the
time associated with the equipment
items reflected the time during the intraservice period when a clinician is using
the piece of equipment, plus any
additional time the piece of equipment
is not available for use for another
patient due to its use during the
designated procedure. We believe that
the direct PE inputs of the new codes
reflect the typical resources required to
furnish the services in question.
However, stakeholders have alerted us
that the resulting PE RVUs for the new
codes reflect an anomalous rank order
in comparison to the previously existing
stand-alone codes. Specifically, the PE
RVUs for the codes that describe CT
scans without contrast for either body
region are greater than the PE RVUs for
74176, which describes a CT scan of
both body regions. We believe that the
anomalous rank order of the PE RVUs
for this series of codes may be the result
of outdated direct PE inputs for the
previously existing stand-alone codes.
The physician work for those codes was
last reviewed by the AMA RUC during
the Third Five-Year Review of Work for
CY 2007. However, the direct PE inputs
for the codes have not been reviewed
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since 2003. Therefore, we are requesting
that the AMA RUC review both the
direct PE inputs and work values of the
following codes in accordance with the
consolidated approach to reviewing
potentially misvalued codes as outlined
in section II.B.2.c. of this final rule with
comment period:
• 72192 Computed tomography,
pelvis; without contrast material.
• 72193 Computed tomography,
pelvis; with contrast material(s).
• 72194 Computed tomography,
pelvis; without contrast material,
followed by contrast material(s) and
further sections.
• 74150 Computed tomography,
abdomen; without contrast material.
• 74160 Computed tomography,
abdomen; with contrast material(s).
• 74170 Computed tomography,
abdomen; without contrast material,
followed by contrast material(s) and
further sections.
Comment: Several commenters
suggested that the rank order anomalies
resulted from a series of issues
unrelated to the direct PE inputs for the
existing component codes. These
commenters argued that the anomaly
resulted from CMS’ refinement of
equipment minutes in the new codes,
errors in CMS’ direct PE database, and
the longstanding CMS policy that new
codes are not subject to practice expense
transitions. Furthermore, the
commenters asserted that the AMA RUC
reviewed the component code direct PE
inputs when developing the direct PE
inputs for the combined codes.
Therefore, the commenters asked that
CMS withdraw its request that the AMA
RUC review the direct PE inputs of the
existing codes.
Response: We refer readers to section
III.B.2 of this final rule with comment
period. There, we address interim final
direct PE inputs from CY 2011,
including accurate allocation of
equipment minutes and, specifically,
the direct PE inputs for CPT codes
74176, 74177, and 74178. In that section
we finalize the interim direct PE inputs
as published in the CY 2011 PFS final
rule, with a minor refinement to the
clinical labor inputs. We note that the
refined PE RVUs for the combined codes
do not significantly alter payment.
While we acknowledge the occasional
irregularities that result from the
application of broad-based payment
transitions, our longstanding policy in a
PFS transition payment year is that if
the CPT Editorial Panel creates a new
code for that year, the new code would
be paid at its fully implemented PFS
amount and not at a transition rate for
that year.
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While the commenters suggested that
the RUC reviewed the direct PE inputs
of the component codes recently, we
have received no recent
recommendation from the RUC
regarding the direct PE inputs for these
codes. Had the RUC reviewed the direct
PE inputs for the component codes and
made recommendations either to
maintain or amend the current direct PE
inputs, we would have responded to
those recommendations. After
considering these comments and noting
the technical refinements to the direct
PE inputs of the combined codes, we
continue to believe that the direct PE
inputs of the component codes should
be reviewed. Therefore, we are
maintaining our request that the RUC
review the component codes.
Tissue Pathology. A stakeholder
informed us that the direct PE inputs
associated with a particular tissue
examination code are atypical.
Specifically, the stakeholder suggested
that the AMA RUC relied upon an
atypical clinical vignette in identifying
the direct PE inputs for the service
associated with CPT code 88305 (Level
IV—Surgical pathology, gross and
microscopic examination). The
stakeholder claims that in furnishing the
typical service, the required material
includes a single block of tissue and 1–
3 slides. The stakeholder argues that the
typical cost of the resources needed to
provide the service is approximately
$18, but the PE RVUs for 2011 result in
a national payment rate of $69.65 for the
technical component of the service.
Because the direct PE inputs associated
with this code have not been reviewed
since 1999, we are asking that the AMA
RUC review both the direct PE inputs
and work values of this code as soon as
possible in accordance with the
consolidated approach to reviewing
potentially misvalued codes as outlined
in section II.B.2.c. of this final rule with
comment period though the work for
this code was reviewed in April 2010.
Comment: Several commenters
disagreed with CMS’ request to review
the work RVU of this code because the
most recent extensive review of the
physician work was conducted by the
RUC in April of 2010. The AMA RUC
expressed concern that CMS would ask
the RUC to review the code solely on
the basis of the stakeholder’s assertions
about overpayment. The AMA RUC
asked CMS to consider that the
stakeholder’s estimates of typical costs
do not reflect the range of practice costs
considered in the PE methodology, and
that the stakeholder should be directed
to consider direct practice expense costs
instead of full practice expense payment
rates.
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Response: We understand the
commenters’ requests to review only the
direct PE inputs for the code since the
physician work for this code and for the
code family were recently reviewed by
the RUC and CMS. We maintain that
conducting a combined review of both
physician work and direct PE for each
code reviewed under our potentially
misvalued codes initiative will lead to
a more comprehensive evaluation and to
more accurate and appropriate
payments under the PFS. However, we
understand that the advantages of a
simultaneous review of work and direct
practice may be limited in the case of
this code where the work was so
recently reviewed. Therefore, we believe
that a review of the direct PE inputs
alone is appropriate.
We acknowledge the RUC’s concern
that the commenter may have been
comparing his perception of direct
practice expense costs with broader
practice expense payments for this code.
We acknowledge the practice expense
portion of PFS payment is developed in
consideration of both direct and indirect
practice expense costs. We also concur
with the RUC that interested
stakeholders can review the publicly
available direct PE inputs associated
with each code. Those inputs are
available in the direct PE database on
the CMS Web site under the downloads
section for the ‘‘CY 2012 PFS final rule
with comment period’’ at: https://
www.cms.gov/PhysicianFeeSched/
PFSFRN/list.asp#TopOfPage.
However, we note that the
stakeholder’s assessment of the direct
costs associated with the typical service
reported using CPT code 88305 is
significantly lower than the summed
direct practice expense inputs currently
associated with the code. Additionally,
as we stated in the CY 2012 PFS
proposed rule, we are asking the RUC to
review the direct PE inputs of the code
because they have not been reviewed
since 1999. We also point out that if the
stakeholder had not brought the concern
to us, this code would have appeared on
our list of PFS high expenditure
procedural codes that had not been
reviewed since CY 2006. After
consideration of these comments, we are
maintaining our request that the RUC
review CPT code 88305, but in the case
of this code, we are only asking for a
review of direct PE inputs.
In Situ Hybridization Testing. We
received comments from the Large
Urology Group Practice Association
(LUGPA) regarding two new
cytopathology codes that describe in
situ hybridization testing of urine
specimens. Prior to CY 2011, in situ
hybridization testing was coded and
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billed using CPT Codes 88365 (In situ
hybridization (e.g., FISH), each probe),
88367 (Morphometric analysis, in situ
hybridization (quantitative or semiquantitative) each probe; using
computer-assisted technology) and
88368 (Morphometric analysis, in situ
hybridization (quantitative or semiquantitative) each probe; manual). The
appropriate CPT code listed would be
billed one time for each probe used in
the performance of the test, regardless of
the medium of the specimen (that is,
blood, tissue, tumor, bone marrow or
urine).
For CY 2011, the AMA’s CPT
Editorial Panel created two new
cytopathology codes that describe in
situ hybridization testing using urine
samples: CPT code 88120
(Cytopathology, in situ hybridization
(e.g., FISH), urinary tract specimen with
morphometric analysis, 3–5 molecular
probes, each specimen; manual) and
CPT code 88121 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis,
3–5 molecular probes, each specimen;
using computer-assisted technology).
Because the descriptors indicate that
the new codes account for
approximately four probes, whereas
88367 and 88368 describe each probe,
there are more PE RVUs associated with
the new codes than with the previously
existing codes that are currently still
used for any specimen except for urine.
However, because the previously
existing codes are billed per probe, the
payment for a test using a different
specimen type could vary depending
upon the number of probes. For
example, a practitioner furnishing a test
involving a blood specimen and using
three probes would bill CPT code 88368
(total RVUs: 6.28) three times with the
result of 18.84 RVUs. A practitioner
furnishing the same test but using a
urine sample instead of a blood sample
would receive payment based on the
13.47 RVUs associated with CPT code
88120.
We accepted the RUC-recommended
work values and direct PE inputs,
without refinement, for the two new
cytopathology codes that describe in
situ hybridization testing using urine
samples. We reviewed the direct PE
recommendations made by the AMA
RUC and considered the inputs to be
appropriate. However, we shared
LUGPA’s concerns regarding the
potential payment discrepancies
between the codes that describe the
same test using different specimen
media. Therefore, in the CY 2012 PFS
proposed rule, we asked the AMA RUC
to review the both the direct PE inputs
and work values of the following codes
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in accordance with the consolidated
approach to reviewing potentially
misvlaued codes as outlined in section
II.B.2.c. of this final rule with comment
period: CPT codes 88365 (In situ
hybridization (e.g., FISH), each probe);
88367 (Morphometric analysis, in situ
hybridization (quantitative or semiquantitative) each probe; using
computer-assisted technology); and
88368 (Morphometric analysis, in situ
hybridization (quantitative or semiquantitative) each probe; manual).
Comment: Several commenters urged
CMS to remove the in situ hybridization
codes from its request for review since
the RUC reviewed the work values for
those codes when valuing the new
codes.
Response: We believe that these codes
exemplify the need to conduct
simultaneous review of direct PE inputs
and physician work and time. As we
explained in the proposal, maintaining
appropriate relativity among payment
rates, and PE RVUs in particular,
requires the assignment of correct direct
PE inputs relative to similar services.
We understand that the RUC
recommended maintaining the work
RVUs for the existing codes in the
context of the recommendation
regarding the new codes, but the
recommendations did not address the
direct PE inputs of the existing codes
that now describe similar tests using
specimen media other than urine.
Comment: LUGPA urged CMS to
resolve the payment discrepancies by
amending the direct PE inputs for 88120
and 88121 in order to equalize payment
with the payment rates with 88367 and
88368. Additionally, the association
suggested that CMS should equalize the
work and malpractice RVUs for these
codes with 88367 and 88368. The
association also reasserted the claim
that the information which CMS
accepted in its totality from the RUC
and the CPT Editorial Panel, with
respect to both the existence of and
values for the new codes, is erroneous
and unsupportable.
Response: We do not agree with the
commenter’s assertion that the technical
resources required in conducting the
urinary tract specimen test with and
without the use of computer-assisted
technology are exactly the same. We
believe that using computer–assisted
technology inherently alters the kind
and amount of direct practice expense
resources typically used in furnishing
services. Therefore, we believe it would
be inappropriate to use the direct inputs
for the manual code in the calculation
of PE RVUs for the code that describes
the service when furnished using
computer-assisted technology.
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However, we continue to share the
commenter’s concerns regarding the
potential payment discrepancies
between the codes that describe the
same test using different specimen
media. If the direct resources required
for conducting the test using urine
specimens are different from the direct
resources required for conducting the
test using other specimen media, we do
not believe it would be appropriate to
assume the typical direct practice
expense inputs for the non-specific
specimen media codes that were
previously valued based upon all the
specimen media including urine are still
accurate now that services using urine
will be reported using different codes.
Therefore, we maintain our request as
stated in the in the CY 2012 PFS
proposed rule (76 FR 42795 and 42796)
that the AMA RUC review both the
direct PE inputs and work values of the
existing codes that describe the test
using specimen media other than urine.
After consideration of these
comments, and in anticipation of
forthcoming review of codes 88365,
88367, and 88368, we are maintaining
for CY 2012 the current direct PE inputs
for CPT codes 88120 and 88121 on an
interim basis subject to public comment.
Ultrasound Equipment. A stakeholder
has raised concerns about potential
inconsistencies with the inputs and the
prices related to ultrasound equipment
in the direct PE database. Upon
reviewing inputs and prices for
ultrasound equipment, we have noted
that there are 17 different pieces of
ultrasound and ultrasound-related
equipment in the database that are
associated with 110 CPT Codes. The
price inputs for ultrasound equipment
range from $1,304.33 to $466,492.00.
Therefore, we are asking the AMA RUC
to review the ultrasound equipment
included in those codes as well as the
way the equipment is described and
priced in the direct PE database.
In the past, the AMA RUC has
provided us with valuable
recommendations regarding particular
categories of equipment and supply
items that are used as direct PE inputs
for a range of codes. For example, in the
2011 PFS final rule (75 FR 73204), we
made changes to a series of codes
following the RUC’s review of services
that include the radiographic
fluoroscopic room (CMS Equipment
Code EL014) as a direct PE input. The
RUC review revealed the use of the item
to no longer be typical for certain
services in which it had been specified
within the direct cost inputs. These
recommendations have often prompted
our proposals that have served to
maintain appropriate relativity within
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the PFS, and we hope that the RUC will
continue to address issues relating to
equipment and supply inputs that affect
many codes. Furthermore, we believe
that in these kinds of cases, it may be
appropriate to make changes to the
related direct PE inputs for a series of
codes without reevaluating the
physician work or other direct PE inputs
for the individual codes. In other words,
while we generally believe that both the
work and the direct practice expense
inputs should be reviewed whenever
the RUC makes recommendations
regarding either component of a code’s
value, we recognize the value of discrete
RUC reviews of direct PE items that
serve as inputs for a series of service
codes.
Comment: Many commenters
expressed agreement with CMS’ interest
in establishing consistency regarding
direct PE inputs for ultrasound
equipment. The RUC agreed to review
the types of equipment and the
assignment to individual codes but
reiterated that the RUC does not make
recommendations related to specific
prices used in the practice expense RVU
calculations. A few commenters urged
CMS and the RUC to provide
manufacturers and other stakeholders
the opportunity to provide input and
feedback to the AMA RUC regarding
descriptive and other information
related to this equipment during any
review.
Response: We appreciate the support
for this request and the efforts of the
RUC in taking on this review. We
remind commenters that because the
AMA RUC is an independent
committee, concerned stakeholders
should communicate directly with the
AMA RUC regarding its professional
composition. We note that we alone are
responsible for all decisions about the
direct PE inputs for purposes of PFS
payment so, while the AMA RUC
provides us with recommendations
based on its broad expertise, we
ultimately remain responsible for
determining the direct PE inputs for all
PFS services. Additionally, we note that
any changes to the equipment inputs
related to ultrasound services will be
made through rulemaking and be
subject to public comment. Finally, we
remind interested stakeholders that
throughout the year we meet with
parties who want to share their views on
topics of interest to them. These
discussions may provide us with
information regarding changes in
medical practice and afford
opportunities for the public to bring to
our attention issues they believe we
should consider for future rulemaking.
(2) Codes Without Direct Practice
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Expense Inputs in the Non-Facility
Setting Certain stakeholders have
requested that we create nonfacility PE
values for a series of kyphoplasty
services CPT codes:
• 22523 (Percutaneous vertebral
augmentation, including cavity creation
(fracture reduction and bone biopsy
included when performed) using
mechanical device, 1 vertebral body,
unilateral or bilateral cannulation (e.g.,
kyphoplasty); thoracic),
• 22524 (Percutaneous vertebral
augmentation, including cavity creation
(fracture reduction and bone biopsy
included when performed) using
mechanical device, 1 vertebral body,
unilateral or bilateral cannulation (e.g.,
kyphoplasty); lumbar).
• 22525 (Percutaneous vertebral
augmentation, including cavity creation
(fracture reduction and bone biopsy
included when performed) using
mechanical device, 1 vertebral body,
unilateral or bilateral cannulation (e.g.,
kyphoplasty); each additional thoracic
or lumbar vertebral body (List separately
in addition to code for primary
procedure)).
In the case of these codes, we are
asking the RUC to make
recommendations regarding the
appropriateness of creating nonfacility
direct PE inputs. If the RUC were to
make direct PE recommendations, we
would review those recommendations
as part of the annual process.
Comment: Several commenters
asserted that determining the
appropriateness of creating nonfacility
direct PE inputs for particular services
is not the role of the RUC. In response
to this request, the RUC provided CMS
with recommended direct PE inputs for
CY 2012, but asserted that the RUC does
not believe that it is within the
Committee’s expertise to determine
whether a service can be performed
safely or effectively in the office setting.
Response: We appreciate the
commenter’s’ perspectives and
understand the RUC’s position. Since
the RUC submitted nonfacility direct PE
input recommendations with its annual
recommendations on new, revised, and
potentially misvalued codes for CY
2012, we priced the services on an
interim basis in the nonfacility setting
for CY 2012. However, we note that the
valuation of a service under the PFS in
particular settings does not address
whether those services are medically
reasonable and necessary in the case of
individual patients, including being
furnished in a setting appropriate to the
patient’s medical needs and condition.
We address the nonfacility direct PE
input recommendations for these codes
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in section III.B.2. of this final rule with
comment period.
(3) Codes Potentially Requiring Updates
to Physician Work
Cholecystectomy. We received a
comment regarding a potential relativity
problem between two cholecystectomy
(gall bladder removal) CPT codes. CPT
code 47600 (Cholecystectomy;) has a
work RVU of 17.48, and CPT code
47605 (Cholecystectomy; with
cholangiography) has a work RVU of
15.98. Upon examination of the
physician time and visits associated
with these codes, we found that CPT
code 47600 includes 115 minutes of
intra-service time and a total time of 420
minutes, including 3 office visits, 3
subsequent hospital care days, and 1
hospital discharge management day.
CPT code 47605 includes 90 minutes of
intra-service time and a total time of 387
minutes, including 2 office visits, 3
subsequent hospital care days, and 1
hospital discharge management day. We
believe that the difference in physician
time and visits is the cause for the
difference in work RVU for these codes.
However, upon clinical review, it does
not appear that these visits
appropriately reflect the relativity of
these two services, as CPT code 47600
should not have more time and visits
associated with the service than CPT
code 47605. Therefore, we are asking
the AMA RUC to review these two
cholecystectomy CPT codes, 47600 and
47605.
Comment: Commenters did not
disagree with us that there is a work
RVU rank order anomaly between codes
47600 and 47605 but they believed
47605 is undervalued. The commenters
agreed that these services should be
reviewed together.
Response: We look forward to
receiving recommendations from the
AMA RUC and reviewing these codes.
We note again that it is essential to
value codes in the context of the code
family and to consider the relativity
with other services of similar time and
intensity outside of the code family.
We thank the public for bringing these
issues to our attention and kindly
request that the public continue to do
so.
6. Expanding the Multiple Procedure
Payment Reduction (MPPR) Policy
a. Background
Medicare has a longstanding policy to
reduce payment by 50 percent for the
second and subsequent surgical
procedures furnished to the same
patient by the same physician on the
same day, largely based on the presence
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of efficiencies in the practice expense
(PE) and pre- and post-surgical
physician work. Effective January 1,
1995, the MPPR policy, with the same
percentage reduction, was extended to
nuclear medicine diagnostic procedures
(CPT codes 78306, 78320, 78802, 78803,
78806, and 78807). In the CY 1995 PFS
final rule with comment period (59 FR
63410), we indicated that we would
consider applying the policy to other
diagnostic tests in the future.
Consistent with recommendations of
MedPAC in its March 2005 Report to the
Congress on Medicare Payment Policy,
under the CY 2006 PFS, the MPPR
policy was extended to the technical
component (TC) of certain diagnostic
imaging procedures performed on
contiguous areas of the body in a single
session (70 FR 70261). The reduction
recognizes that, for the second and
subsequent imaging procedures, there
are some efficiencies in clinical labor,
supplies, and equipment time. In
particular, certain clinical labor
activities and supplies are not
duplicated for subsequent procedures
and, because equipment time and
indirect costs are allocated based on
clinical labor time, those would also be
reduced accordingly.
The imaging MPPR policy originally
applied to computed tomography (CT)
and computed tomographic angiography
(CTA), magnetic resonance imaging
(MRI) and magnetic resonance
angiography (MRA), and ultrasound
services within 11 families of codes
based on imaging modality and body
region. When we adopted the policy in
CY 2007, we stated that we believed
efficiencies were most likely to occur
when imaging procedures are performed
on contiguous body areas because the
patient and equipment have already
been prepared for the second and
subsequent procedures, potentially
yielding resource savings in areas such
as clerical time, technical preparation,
and supplies (70 FR 45850). The MPPR
policy originally applied only to
procedures furnished in a single session
involving contiguous body areas within
a family of codes, not across families.
Additionally, while the MPPR policy
applies to TC-only services and to the
TC of global services, it does not apply
to professional component (PC) services.
Under the current imaging MPPR
policy, full payment is made for the TC
of the highest paid procedure, and
payment is reduced by 50 percent of the
TC for each additional procedure when
an MPPR scenario applies. We
originally planned to phase in the
imaging MPPR policy over a 2-year
period, with a 25 percent reduction in
CY 2006 and a 50 percent reduction in
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CY 2007 (70 FR 70263). However, the
Deficit Reduction Act of 2005 (DRA)
(Pub. L. 109–171) amended the statute
to place a cap on the PFS payment
amount for most imaging procedures at
the amount paid under the hospital
outpatient prospective payment system
(OPPS). In view of the new OPPS
payment cap added by the DRA, we
decided in the PFS final rule with
comment period for 2006 that it would
be prudent to retain the imaging MPPR
at 25 percent while we continued to
examine the appropriate payment levels
(71 FR 69659). The DRA also exempted
reduced expenditures attributable to the
imaging MPPR policy from the PFS
budget neutrality provision. Effective
July 1, 2010, section 3135(b) of the
Affordable Care Act amended the statute
to increase the MPPR on the TC of
imaging services under the policy
established in the CY 2006 PFS final
rule with comment period from 25 to 50
percent, and exempted the reduced
expenditures attributable to this further
change from the PFS budget neutrality
provision.
In the July 2009 GAO report entitled,
‘‘Medicare Physician Payments: Fees
Could Better Reflect Efficiencies
Achieved when Services are Provided
Together,’’ the GAO recommended that
we take further steps to ensure that fees
for services paid under the PFS reflect
efficiencies that occur when services are
furnished by the same physician to the
same beneficiary on the same day. The
GAO recommended the following: (1)
expanding the existing imaging MPPR
policy for certain services to the PC to
reflect efficiencies in physician work for
certain imaging services; and (2)
expanding the MPPR to reflect PE
efficiencies that occur when certain
nonsurgical, nonimaging services are
furnished together. The GAO report also
encouraged us to focus on service pairs
that have the most impact on Medicare
spending.
In its March 2010 report, MedPAC
noted its concerns about mispricing of
services under the PFS. MedPAC
indicated that it would explore whether
expanding the unit of payment through
packaging or bundling would improve
payment accuracy and encourage more
efficient use of services.
In the CYs 2009 and 2010 PFS
proposed rules (73 FR 38586 and 74 FR
33554, respectively), we stated that we
planned to analyze nonsurgical services
commonly furnished together (for
example, 60 to 75 percent of the time)
to assess whether an expansion of the
MPPR policy could be warranted.
MedPAC encouraged us to consider
duplicative physician work, as well as
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PE, in any expansion of the MPPR
policy.
Section 1848(c)(2)(K) of the Act (as
added by section 3134(a) of the
Affordable Care Act) specifies that the
Secretary shall identify potentially
misvalued codes by examining multiple
codes that are frequently billed in
conjunction with furnishing a single
service, and review and make
appropriate adjustments to their relative
values. As a first step in applying this
provision, in the CY 2010 final rule with
comment period, we implemented a
limited expansion of the imaging MPPR
policy to additional combinations of
imaging services.
Effective January 1, 2011 the imaging
MPPR applies regardless of code family;
that is, the policy applies to multiple
imaging services furnished within the
same family of codes or across families.
This policy is consistent with the
standard PFS MPPR policy for surgical
procedures that does not group
procedures by body region. The current
imaging MPPR policy applies to CT and
CTA, MRI and MRA, and ultrasound
procedure services furnished to the
same patient in the same session,
regardless of the imaging modality, and
is not limited to contiguous body areas.
We note that section
1848(c)(2)(B)(v)(VI) of the Act (as added
by section 3135(b) of the Affordable
Care Act) specifies that reduced
expenditures attributable to the increase
in the imaging MPPR from 25 to 50
percent (effective for fee schedules
established beginning with 2010 and for
services furnished on or after July 1,
2010) are excluded from the PFS budget
neutrality adjustment. That is, the
reduced payments for code
combinations within a family of codes
(contiguous body areas) are excluded
from budget neutrality. However, this
exclusion only applies to reduced
expenditures attributable to the increase
in the MPPR percentage from 25 to 50
percent, and not to reduced
expenditures attributable to our policy
change regarding additional code
combinations across code families (noncontinguous body areas) that are subject
to budget neutrality under the PFS
The complete list of codes subject to
the CY 2012 MPPR policy for diagnostic
imaging services is included in
Addendum F.
As a further step in applying the
provisions of section 3134(a) of the
Affordable Care Act, effective January 1,
2011, we implemented an MPPR for
therapy services. The MPPR applies to
separately payable ‘‘always therapy’’
services, that is, services that are only
paid by Medicare when furnished under
a therapy plan of care. Contractor-priced
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codes, bundled codes, and add-on codes
are excluded because an MPPR would
not be applicable for ‘‘always therapy’’
services furnished in combination with
these codes. The complete list of codes
subject to the MPPR policy for therapy
services is included in Addendum H.
In the CY 2011 proposed rule (75 FR
44075), we proposed to apply a 50
percent payment reduction to the PE
component of the second and
subsequent therapy services for multiple
‘‘always therapy’’ services furnished to
a single patient in a single day.
However, in response to public
comments, in the CY 2011 PFS final
rule with comment period (75 FR
73232), we adopted a 25 percent
payment reduction to the PE component
of the second and subsequent therapy
services for multiple ‘‘always therapy’’
services furnished to a single patient in
a single day.
Subsequent to publication of the CY
2011 PFS final rule with comment
period, section 3 of the Physician
Payment and Therapy Relief Act of 2010
(Pub. L. 111–286) revised the payment
reduction percentage from 25 percent to
20 percent for therapy services
furnished in office settings. The
payment reduction percentage remains
at 25 percent for services furnished in
institutional settings. Section 4 of the
Physician Payment and Therapy Relief
Act of 2010 exempted the reduced
expenditures attributable to the therapy
MPPR policy from the PFS budget
neutrality provision. Under our current
policy as amended by the Physician
Payment and Therapy Relief Act, for
institutional services, full payment is
made for the service or unit with the
highest PE and payment for the PE
component for the second and
subsequent procedures or additional
units of the same service is reduced by
25 percent. For non-institutional
services, full payment is made for the
service or unit with the highest PE and
payment for the PE component for the
second and subsequent procedures or
additional units of the same service is
reduced by 20 percent.
The MPPR policy applies to multiple
units of the same therapy service, as
well as to multiple different services,
when furnished to the same patient on
the same day. It applies to services
furnished by an individual or group
practice or ‘‘incident to’’ a physician’s
service. The MPPR applies when
multiple therapy services are billed on
the same date of service for one patient
by the same practitioner or facility
under the same National Provider
Identifier (NPI), regardless of whether
the services are furnished in one
therapy discipline or multiple
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disciplines, including, physical therapy,
occupational therapy, or speechlanguage pathology.
The MPPR policy applies in all
settings where outpatient therapy
services are paid under Part B. This
includes both services paid under the
PFS that are furnished in the office
setting, as well as to institutional
services paid at the PFS rates that are
furnished by outpatient hospitals, home
health agencies, comprehensive
outpatient rehabilitation facilities
(CORFs), and other entities that are paid
under Medicare Part B for outpatient
therapy services.
In its June 2011 Report to the
Congress, MedPAC further discussed its
concern about the significant growth in
ancillary services, specifically services
for which physicians can self-refer
under the in office ancillary exceptions
list for the Ethics in Patient Referrals
Act (also known as the Stark Law)
including imaging, other diagnostic
tests, and therapeutic services such as
physical therapy and radiation therapy.
MedPAC argues, in its June 2011 Report,
that inaccurate pricing has played a role
in this growth, and that there are
additional efficiencies to be achieved in
pricing imaging services
notwithstanding a series of payment
adjustments for imaging services over
the past several years. MedPAC
specifically recommended a multiple
procedure payment reduction to the
professional component of diagnostic
imaging services provided by the same
practitioner in the same session.
b. CY 2012 Expansion of the MPPR
Policy to the Professional Component of
Advanced Imaging Services
Over the past few years, as part of the
potentially misvalued service initiative,
the AMA RUC has examined several
services that are billed together 75
percent or more of the time as part of
the potentially misvalued service
initiative. In several cases, the AMA
RUC-recommended work values for new
codes that describe the combined
services, and those recommended
values reflected the expected
efficiencies. For example, for CY 2011,
the AMA RUC valued the work for a
series of new codes that describe CT of
the abdomen and pelvis, specifically
CPT codes:
• 74176 (Computed tomography,
abdomen and pelvis; without contrast
material).
• 74177 (Computed tomography,
abdomen and pelvis; with contrast
material).
• 74178 (Computed tomography,
abdomen and pelvis; without contrast
material in one or both body regions,
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followed by with contrast material(s)
and further sections in one or both body
regions).
We accepted the work values
recommended by the AMA RUC for
these codes in the CY 2011 PFS final
rule with comment period (75 FR
73229). The recommended work values
reflected an expected efficiency for the
typical combined service that paralleled
the reductions that would typically
result from a MPPR adjustment. For
example, in support of the
recommended work value of 1.74 RVUs
for 74176, the AMA RUC explained that
the full value of 74150 (Computed
tomography, abdomen; without contrast
material) (Work RVU = 1.19) plus half
the value of 72192 (Computed
tomography, pelvis; without contrast
material) (1⁄2 Work RVU = 0.55) equals
1.74 work RVUs. The AMA RUC stated
that its recommended valuation was
appropriate even though the combined
current work RVUs for of 74150 and
72192 would result in a total work RVU
of 2.28. Furthermore, the AMA RUC
validated its estimation of work
efficiency for the combined service by
comparing the code favorably with the
work value associated with 74182
(Magnetic resonance, for example,
proton imaging, abdomen; with contrast
material(s)) (Work RVU = 1.73), which
has a similar intra-service time, 20
minutes. Thus, we believe our current
and final MPPR formulations are
consistent with the AMA RUC’s work to
review code pairs for unaccounted-for
efficiencies and to appropriately value
comprehensive codes for a bundle of
component services.
We continue to believe that there may
be additional imaging and other
diagnostic services for which there are
efficiencies in work when furnished
together, resulting in potentially
excessive payment for these services
under current policy. MedPAC also
made this same observation in their
recent June 2011 Report to the Congress.
As noted, Medicare has a
longstanding policy to reduce payment
by 50 percent for the second and
subsequent surgical procedures and
nuclear medicine diagnostic procedures
furnished to the same patient by the
same physician on the same day.
In continuing to apply the provisions
of section 3134(a) of the Affordable Care
Act, for CY 2012 we proposed to expand
the MPPR to the PC of Advanced
Imaging Services (CT, MRI, and
Ultrasound), that is, the same list of
codes to which the MPPR on the TC of
advanced imaging already applies (see
Addendum F). Thus, the MPPR would
apply to the PC and the TC of the codes.
Specifically, we proposed to expand the
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50 percent payment reduction currently
applied to the TC to apply also to the
PC of the second and subsequent
advanced imaging services furnished in
the same session. Full payment would
be made for the PC and TC of the
highest paid procedure, and payment
would be reduced by 50 percent for the
PC and TC for each additional
procedure furnished to the same patient
in the same session. This proposal was
based on the expected efficiencies in
furnishing multiple services in the same
session due to duplication of physician
work—primarily in the pre- and postservice periods, with smaller
efficiencies in the intra-service period.
The proposal is consistent with the
statutory requirement for the Secretary
to identify, review, and adjust the
relative values of potentially misvalued
services under the PFS as specified by
section 3134(a) of the Affordable Care
Act. The proposal is also consistent both
with our longstanding policy on surgical
and nuclear medicine diagnostic
procedures, which apply a 50 percent
reduction to second and subsequent
procedures. Furthermore, it is
responsive to continued concerns about
significant growth in imaging spending,
and to MedPAC (March 2010, June
2011) and GAO (July 2009)
recommendations regarding the
expansion of MPPR policies under the
PFS to account for additional
efficiencies.
Finally, as noted, the proposal is
consistent with the AMA RUC’s recent
methodology and rationale in valuing
the work for a combined CT of the
pelvis (CPT codes 72192, 72193 and
72194), and abdomen (CPT codes 74150,
74160 and 74170) where the AMA RUC
assumed the work efficiency for the
second service was 50 percent. Savings
resulting from this proposal would be
redistributed to other PFS services as
required by the general statutory PFS
budget neutrality provision.
Comment: Overall, most commenters
opposed the expansion of the imaging
MPPR policy to the PC. While many
commenters acknowledged that there
may be minimal efficiencies in the PC
of second and subsequent procedures,
they stated a 50 percent reduction was
excessive. Commenters who agreed that
some efficiencies exist indicated that
activities with potential for duplication
included: Review of medical history and
prior imaging studies; review of the
final report; and discussion of findings
with the referring physician.
In contrast, a few commenters,
including MedPAC, supported the
proposal. MedPAC indicated that the
proposal is consistent with the
recommendation from its June 2011
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Report to the Congress; noted that recent
recommendations from the AMA RUC
offer additional support; and agreed
with a proposal to align the MPPR
policy for the technical and professional
portions of an imaging service.
Commenters opposed to our proposal
raised several issues about the basis for
CMS’ proposed 50 percent reduction to
the professional component for second
and subsequent imaging services Many
commenters cited a recent article
entitled, ‘‘Professional Component
Payment Reductions for Diagnostic
Imaging Examinations When More Than
One Service Is Rendered by the Same
Provider in the Same Session: An
Analysis of Relevant Payment Policy,’’
published June 29, 2011, in the Journal
of the American College of Radiology’’.
The article argues that efficiencies
within the professional component of
advanced diagnostic imaging services
including radiography and fluoroscopy,
ultrasound, nuclear medicine, CT, and
MRI are minimal and vary greatly across
modalities. The article was authored by
a group of radiologists that also
participate in AMA RUC activities. They
reached their conclusion after a review
of the work for codes in the AMA RUC
Resource Based Relative Value Scale
Data Manager database. The authors
focused their review on pre-service and
post-service activities and did not
review intra-service activities. The
authors point out that pre- and postservice time is not a significant portion
of time for imaging studies, unlike
surgical procedures. The maximum
percentage of potentially duplicated
pre-service and post-service activity that
this team identified ranged from 19
percent for nuclear medicine to 24
percent for ultrasound. The authors
found a maximum percentage work
reduction by modality ranging from 4.32
percent for CT to 8.15 percent for
ultrasound. This translates to a
maximum reduction in the professional
component of only 2.96 percent for CT
to 5.45 percent for ultrasound.
Commenters point out that neither
GAO nor MedPAC supported a specific
percentage reduction, but recommended
that CMS conduct a review and analysis
to determine the extent of efficiencies
associated with the PC of multiple
imaging services, and suggested that
such efficiencies may vary by modality.
Commenters highlighted several
perceived deficiencies in the GAO’s
technical methodology, including a
failure to distinguish between pre- postand intra- physician work intensity,
failure to recognize the wide variability
in pre- and post- service time allocation
among varied imaging services which
makes a blanket policy more imprecise,
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and failure to consider clinical practice.
Commenters argued that CMS provided
no analysis to support the proposed
MPPR level of 50 percent and did not
identify potential areas of duplication in
the pre-, post- and intra-service periods.
Commenters expressed views
regarding our reference to the AMA
RUC valuation of the work for bundled
codes for CT of the pelvis and abdomen.
Many commenters did not believe it was
appropriate to propose a 50 percent
MPPR to the PC for all advanced
imaging services based on the AMA
RUC’s 50 percent reduction in work
RVUs when valuing the combined
pelvis and abdomen CT codes.
Commenters indicated that the bundled
code pair is not representative of most
code pairs in that it is a focused
contiguous body area using the same
modality with significant overlap in the
regions evaluated. Commenters noted
that the AMA RUC has not consistently
found a 50 percent reduction in
physician work when imaging services
are performed together.
The AMA RUC also objected to CMS
using its recommended work values for
the CT of Abdomen/Pelvis to
substantiate our proposal. The AMA
RUC asserted that it developed the
recommended physician work values by
estimating the magnitude of the
physician work of the surveyed codes
relative to physician work values of
MRI, MRA, and evaluation and
management services. When valuing the
code for CT of Abdomen/Pelvis, the
AMA RUC did not believe that the
recommended physician work RVUs
should be lower than the total RVUs
resulting from applying a 50 percent
MPPR to the professional component of
the second and subsequent imaging
service in the CT Abdomen/Pelvis code
pair. The AMA RUC pointed out that
the committee arrived at the
recommended values using magnitude
estimation and did not sum values for
the component codes as suggested by
CMS in the proposed rule.
Some commenters acknowledged that
there are some efficiencies in the
combined CT of the abdomen and
pelvis, noting that overlapping images
on a CT of the abdomen and pelvis may
require less scrutiny. Commenters also
noted that the physician has to review
the patient history and provide dictation
only once for multiple scans. Other
commenters rejected the idea that there
are efficiencies in the CT of the
abdomen and pelvis. Commenters
indicated that the service included only
about 75 images 5 years ago. Today, it
includes approximately 375 images,
with the addition of thinner slice images
and multiplanar reformatting.
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Many commenters maintained that
the proposed 50 percent MPPR for the
PC of advanced imaging services is
based on erroneous assumptions and a
misunderstanding of the practice of
medicine. These commenters argued
that, generally, patients who are having
multiple imaging studies on the same
day tend to be patients who are
seriously ill or injured patients,
including cancer, trauma and stroke
patients who invariably have
significantly more complex pathology,
requiring more time, rather than less. In
some cases, the image using an initial
modality may be inconclusive, requiring
use of another imaging modality.
Commenters argued that there are no
efficiencies in physician work for
interpretation of multiple advanced
imaging scans for trauma and cancer
patients, where images are less likely to
be of contiguous anatomic areas.
Commenters maintained that, on
average, studies with comparisons take
longer than those that do not have
comparison studies. The radiologists
must look at more films and, when
abnormalities are present, must compare
each finding to the previous exam. The
more studies there are, the more time it
takes to interpret each one. Commenters
asserted that radiologists are morally
and professionally obligated to spend an
equal amount of time, effort, and skill
on interpreting images, irrespective of
whether previous examinations have
been performed on the same patient on
the same day.
Finally, several commenters argued
that technological advances in imaging
have increased the intra-service work
requiring radiologists to review many
more images and more complex images
than when the services were originally
valued. They argue that contrary to the
CMS proposal, clinical practice has
become more time consuming because
of the need to review hundreds of
images per study compared to earlier
imaging methods which took far fewer
images. In addition to axial images,
there frequently are coronal, sagittal,
and oblique sequences as well as
maximal intensity 3D images with each
study. Images of non-contiguous body
areas, for example, a CT of the brain and
abdomen, are unrelated and are often
read by different specialists, each
separately requiring dedicated time for
interpretation. Further, the search
patterns used to identify possible issues
in the images are different; technical
aspects of viewing non-contiguous
images are different; and the mental
process used to formulate differential
diagnoses are often unrelated. In some
cases, such as when it is necessary to rereview prior images, commenters stated
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that more time may be required
compared to the time required to review
a single image.
Response: We appreciate the many
comments submitted on this proposal.
However, we continue to believe that
some level of duplication exists in the
PC service for second and subsequent
advanced imaging services. While our
initial proposal was developed with
reference to existing MPPR policies and
supported by the AMA RUC valuation
of new bundled CT imaging codes, as
commenters recommended, we have
performed additional analysis for this
final rule with comment period.
Specifically, we have reviewed the
vignettes in the AMA RUC database for
12 high volume code pairs where
vignettes were available. The codes we
reviewed appear in Table 8 and
constituted about 30 percent of
utilization for the advanced imaging
codes performed on the same day in CY
2010 claims data. Although our analysis
did not include code pairs with
different modalities, we note that our
claims data indicate that such code
pairs represent only 3 percent of
expenditures for advanced imaging
codes. Therefore, we do not believe the
typical multiple advanced imaging
scenario involves more than one
modality. We also note that our analysis
did not include ultrasound code pairs as
there are no vignettes or specific
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physician times for these services in the
AMA RUC database. To identify
potential duplication in the PC of the
code combinations for which vignettes
and physician times were available, we
performed a clinical assessment to
identify the level of duplication in the
typical case and assigned a reduction
percentage of either 0, 25, 50, 75 or 100
to each vignette component in the
pre-, post-, and intra-service periods.
Our claims analysis revealed that the
majority of multiple imaging studies
were for contiguous anatomic areas
including thorax and abdomen/pelvis,
and head/brain and neck/spine, and
utilized the same modality. This
suggests that multiple studies are
typically performed to view a single
underlying pathology that spans either
multiple regions or lies in the region of
overlap where a single study might be
suboptimal. If the reasons for the studies
were relatively unrelated, the observed
association between contiguous areas
and same modality would not exist.
Conversely, the observation of this firm
association between multiple studies on
the same day implies that there are
some efficiencies in interpreting history;
predicting pathology; selecting
protocols; reviewing scout and
technique scans; focusing on particular
tissue types and imaging windows;
reviewing overlapping fields; reporting
preliminary if not final results; and
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follow-up discussions with patients,
staff and physicians. In contrast to the
analysis published by the ACR, we
found—
• Significant duplication in the preservice work, which consists of
reviewing patient history and any prior
imaging studies, and determining the
protocol and communicating that
protocol with technologists;
• Significant duplication in the postservice work, which almost always
consists of reviewing and signing a final
report and discussing findings with the
referring physician; and
• Moderate efficiencies in intraservice work. Specifically, supervising
contrast (where appropriate),
interpreting the examination and
comparing it to other studies, and
dictating the report for the medical
record.
In conclusion, our analysis showed
that, after applying a reduction
percentage to each vignette component
for the second and subsequent scans,
identified as the code(s) in the code pair
with the lower professional component
RVU, and adjusting for intensity
differences between pre-service and
post-service work and intra-service
work, the total RVU reduction ranges
from 27.3 to 43.1 percent for second and
subsequent procedures in the 12 code
pairs.
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Based on our further analysis and in
response to comments, we believe that
a 25 percent reduction would more
appropriately capture the range of
physician work efficiencies for second
and subsequent imaging services
furnished by the same physician
(including physicians in the same group
practice) to the same patient in the same
session on the same day.
Commenters expressed concerns that
there is wide variation in the potential
efficiencies among different code pairs
that such variability precludes broad
application of a single percentage
reduction, and that establishing new
combined codes is the only mechanism
for capturing accurate payment, for
multiple imaging services. In general,
we believe that MPPR policies capture
efficiencies when several services are
furnished in the same session and that
it is appropriate to apply a single
percentage reduction to second and
subsequent procedures to capture those
efficiencies. Because of the myriad
potential combinations of advanced
imaging scans, establishing new
combined codes for each combination of
advanced imaging scans is unwieldy
and impractical. An MPPR policy is not
precise, but reflects efficiencies in the
aggregate, such as common patient
history, interpretation of multiple
images involving the same patient and
same anatomical structures, and,
typically, same modality. Our analysis
of the specific activities included in
furnishing advanced imaging scans
together supports a reduction between
27.3 and 43.1 percent. The
implementation of a 25 percent
reduction in the PC for second and
subsequent imaging services furnished
by the same physician in the same
session is less than range of reductions
we observed for second and subsequent
scans in our analysis. Therefore, while
we acknowledge that efficiencies may
vary across code pairs, we believe that
a 25 percent reduction in the PC is
reasonable and supported by our
analysis. We note that, as with many of
our policies, we will continue to review
this MPPR policy and refine it as
needed in future years to ensure that we
continue to provide accurate payments
under the PFS.
We disagree with commenters’
assertions that there are no efficiencies
in physician work for the interpretation
of multiple advanced imaging scans for
trauma and cancer patients. As noted
previously, our analysis indicates that
the typical multiple imaging case
involves contiguous body areas, and
only a very small percentage involve
more than one modality. We note that
this analysis included all claims data,
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including trauma and cancer patient
imaging studies. In addition, we used
conservative estimates of the reduction
percentages for the observed efficiencies
for second and subsequent procedures
in our analysis. Finally, we believe there
are efficiencies in work for all multiple
imaging studies, including the review of
medical history and prior imaging
studies; contrast administration; review
of the final report; and discussion of
findings with the referring physician,
regardless of the type of injury or
patient’s diagnosis.
Concerning comparison studies, we
note that when interpreting previous
studies, the radiologist would interpret
not just the prior image itself, but also
the patient history or, at a minimum, the
portfolio of similar available studies.
While we understand that time spent
reviewing prior studies adds work by
requiring the radiologist to review such
studies, we believe that the availability
of prior studies may also reduce work
by creating a baseline against which
new images can be quickly compared.
Commenters were also concerned
with technological advances that may
exponentially multiply the number of
images that are produced in a single
imaging session. While we agree with
commenters that technology has
multiplied the number of images
produced, we note that that same
technology has vastly improved
viewability. The use of shuttles to scan
through a series of images along imaged
axis, 3–D rendering to allow
visualization, rotation and zoom, and
modeling to enhance suspect findings
and increase the utility of pattern
recognition all exist to improve the
efficiency of data extraction that at one
time had to be visualized entirely in the
mind of the radiologist from a series of
side-by-side flat images. Therefore, we
believe that, in the aggregate,
technological advances in imaging have
not significantly increased the work of
interpretation. Efficiencies resulting
from technological advances are even
more evident in cases of multiple
contiguous images, where rendering
allows joystick maneuvering through a
single continuous image that may be
billed independently, but which may be
acquired as a single activity. Finally, we
note that other commenters, and the
study cited by the American College of
Radiology, have acknowledged some
efficiencies do exist and are not
currently recognized in the coding and
payment structure of these codes.
Comment: The AMA RUC requested
that CMS continue to support the
activities of the joint CPT/RUC
workgroup to identify services that can
be bundled together into one
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comprehensive code and to make sure
that this bundled code is valued
appropriately. The AMA RUC noted that
it utilizes Medicare claims data to
ensure that it understands what services
are reported in conjunction with the
codes that are under their review, and
to ensure that there is no duplication of
pre-service and post-service work, or in
practice costs. The AMA RUC maintains
that any duplication in the PC that may
exist when performing two or more
imaging services has already been
removed from the individual codes as it
is assumed that there are a certain
number of instances for which one
service will be furnished and reported
with another service. The AMA RUC
maintains that further expansion of the
MPPR to the PC would result in
unwarranted and unfair reductions to
the payment rate. The AMA RUC has
found, through review of survey data,
that when codes are commonly reported
together (that is, more than 75 percent
of the time), the duplication in
physician work for the second or
subsequent services is not consistently
50 percent, and may range from
anywhere between 0 percent and 100
percent. The AMA RUC views its
current project to address efficiencies on
an individual basis with bundled codes
to be a fair and consistent process.
Commenters noted that thirteen new
bundled CPT codes have been
developed and valued by the AMA RUC
so far, and more bundled codes are
being developed for the 2013 and 2014
CPT cycles. Therefore, the AMA RUC
believes its efforts should more than
address the GAO recommendation to
systematically review services
commonly furnished together, and that
CMS’ implementation of the imaging
MPPR policy for the professional
component of advanced imaging
services is not warranted at this time.
Response: The imaging MPPR is not
intended to supersede the AMA RUC
process of developing recommended
values for services described by CPT
codes. We appreciate the work by the
AMA RUC and encourage them to
continue examining code pairs for
duplication based upon the typical case,
and appropriately valuing new
comprehensive codes for bundled
services that are established by the CPT
Editorial Panel. We view the AMA RUC
process and the MPPR policy as
complimentary and equally reasonable
means to the appropriate valuation and
payment for services under the PFS.
Codes subject to the MPPR that are
subsequently bundled would no longer
be subject to the MPPR when billed
alone in a single session. At the same
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time, the adoption of the MPPR for the
PC of advanced imaging services will
address duplications in work to ensure
that multiple imaging services are paid
more appropriately. As noted
previously, we believe that an MPPR
policy addresses work efficiencies
present when more than one advanced
imaging service is performed in the
same session, and that creating new
comprehensive codes to capture the
myriad of unique combinations of
advanced imaging services that could be
performed in the same session would be
unwieldy and impractical. In addition,
we believe that the expansion of the
MPPR policy for advanced imaging
services to the PC is consistent with
both the GAO and MedPAC
recommendations. We note that as more
code combinations are bundled into a
single complete service reported by one
CPT code, the MPPR policy would no
longer apply for the combined services.
For example, the MPPR no longer
applies when the single code is billed
for a combined CT of the pelvis and
abdomen performed in the same
session.
Comment: In the proposed rule, we
cited section 3134 of the Affordable
Care Act, which requires the Secretary
identify potentially misvalued codes by
examining multiple codes that are
frequently billed in conjunction with
furnishing a single service, and to
review and make appropriate
adjustments to their relative values. A
commenter believed that we
inappropriately relied on this authority
to justify the expansion of the MPPR to
PC services. The commenter noted that
we stated in the PFS final rule for 2011
that ‘‘[b]ecause of the different pieces of
equipment used for CT/CTA, MRI/MRA,
and ultrasound procedures, it would be
highly unlikely that a single practitioner
would furnish more than one imaging
procedure involving two different
modalities to one patient in a single
session where the proposed MPPR
would apply.’’ Therefore, the
commenter concluded that we should
not rely on the authority under section
3134 of the Affordable Care Act to
adjust payment for ‘‘codes that are
frequently billed in conjunction with
furnishing a single service’’ as the basis
to expand the MPPR policy to
procedures that we conceded are rarely
billed together.
Response: We believe that the
application of the MPPR to the PC of
second and subsequent advanced
imaging services furnished in the same
session to the same patient is fully
consistent with section 1848(c(2)(K) of
the Act (as added by section 3134 of the
Affordable Care Act). Additionally, we
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believe the proposed MPPR is consistent
with our authority under section
1848(c)(2)(B) of the Act which requires
us to review the relative and make
adjustments to values for physicians’
services at least once every 5 years, and
with our authority to establish ancillary
policies under section 1848(c)(4) of the
Act. As noted previously, we have had
several MPPR policies in place for many
years before the enactment of section
3134 of the Affordable Care Act.
As explained previously, section
1848(c)(2)(K)(i) of the Act requires the
Secretary to identify services within
several specific categories as being
potentially misvalued, and to make
appropriate adjustments to their relative
values. One of the specific categories
listed under section 1834(c)(2)(K)(ii) of
the Act is ‘‘multiple codes that are
frequently billed in conjunction with
furnishing a single service.’’
Therefore, we do not agree with the
commenters that the MPPR policy
undermines the goals of the Affordable
Care Act. It appears the commenter may
have misunderstood the point of the
quoted statement from the proposed
rule that, ‘‘[b]ecause of the different
pieces of equipment used for CT/CTA,
MRI/MRA, and ultrasound procedures,
it would be highly unlikely that a single
practitioner would furnish more than
one imaging procedure involving two
different modalities to one patient in a
single session where the proposed
MPPR would apply.’’ The commenter is
correct that we conceded, in the
circumstance where two different
modalities are used, it is unlikely that
two advanced imaging codes would be
billed by a single physician for a single
patient in a single session. However, the
point of this statement was to indicate
that the proposed MPPR would not
apply in the vast majority of these
situations. Although there remains the
remote possibility that the MPPR would
apply in a scenario where the codes for
multiple advanced imaging services are
not ‘‘frequently billed in conjunction
with furnishing a single service,’’ we
believe this would be exceedingly rare.
Moreover, we would expect there to be
some level of efficiencies in work even
in these cases. As we indicated in the
CY 2011 PFS final rule with comment
period (75 FR 73231), application of a
general MPPR policy to numerous
imaging service combinations may
result in an overestimate of efficiencies
in some cases and an underestimate in
others. But this can be true for any
service paid under the PFS, and we
believe it is important to establish a
general policy to pay appropriately for
the typical service or services furnished.
Given that, based on our review of CY
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2010 claims data, 97 percent of second
and subsequent advanced imaging
services furnished to the same patient
on the same day involved the use of the
same imaging modality, and that some
of the cases that did involve different
modalities might have been furnished
by different physicians in different
group practices (in which case the
MPPR would not apply), we do not
believe it is necessary to adjust our
MPPR policy to address an uncommon
scenario. Therefore, we believe the
MPPR policy is fully consistent with
section 1848(c)(2)(K) of the statute, as
added by section 3134(a) of the
Affordable Care Act, and that the policy
fulfills several of our key statutory
obligations by more appropriately
valuing combinations of imaging
services furnished to patients and paid
under the PFS.
Comment: Commenters indicated that
contemporary radiology is not designed
to distinguish between imaging
procedures performed during the
‘‘same’’ or ‘‘different’’ sessions with any
degree of reliability. There is no
practical method to reliably and
efficiently make this distinction. This
challenge is made even more difficult
when the issue of ‘‘same’’ versus
‘‘different’’ interpreting physician(s) is
taken into account. The process will
also be challenging to auditors who will
likely suggest that the burden is on the
practice to prove claims submitted with
a -59 modifier actually occurred in a
separate session. Commenters are
concerned that it is unclear how this
can be efficiently documented, and
request that this be considered before
any new policy is adopted.
Commenters noted that imaging tests
utilizing different modalities are rarely
performed in the same session. For
example, a patient may undergo an
ultrasound, which would be interpreted
by the physician to determine whether
the patient requires a CT for further
diagnostic evaluation. The physician
supervises and/or performs and
interprets each test separately, at
different times, and speaks to the
patient about the results of each test on
separate occasions during the patient’s
visit. Also, separate written reports are
required for each test.
Commenters further noted that in
multiple trauma cases, the same
radiologist would not interpret the
entire series of exams. In addition, there
are cases when a radiologist determines
upon review that X-rays were
insufficient to determine the problem
and, therefore, recommends another
type of imaging study be performed. The
same radiologist may review the results
of this second imaging test for the same
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patient later in the same day. In this
case, the radiologist needs to complete
an entire dictation to reflect the
subsequent study and provide his
professional interpretation. Commenters
specifically asked whether the MPPR
would apply when—
• A physician does not read both
scans together, for example, in
emergency situations even though both
scans were performed in the same
session;
• Two physicians with different
specialties each read a separate scan of
a patient, though both scans were taken
during the same session; and
• Physicians are in the same group
practice.
Response: The MPPR for the PC of
advanced imaging services applies to
procedures furnished to the same
patient, in the same session, on the
same day. For purposes of the MPPR on
the PC, scans interpreted at widely
different times (such as in the
emergency situation noted) would
constitute separate sessions, even
though the scans themselves were
conducted in the same session and the
MPPR on the TC would apply. We
further recognize that in some cases,
imaging tests utilizing different
modalities may be conducted in
separate sessions for the TC service,
such as when the patient must be
moved to another floor of the hospital;
however, the PC services in such cases
may, or may not, be furnished in
separate sessions. As with the MPPR for
multiple surgery, the MPPR on the PC
for advanced imaging services applies in
the case of multiple procedures
furnished by a single physician or by
multiple physicians in the same group
practice. As a general policy, however,
when multiple scans are conducted on
a patient in the same session, we would
generally consider the interpretations of
those scans to be furnished in the same
session, including cases when furnished
by different physicians in the same
group practice. In cases where the
physician demonstrates the medical
necessity of furnishing interpretations
in separate sessions, use of the -59
modifier would be appropriate. We
recognize that it may not always be a
simple matter to determine whether a
service was furnished in the ‘‘same’’
session, particularly in the case of the
PC. The physician will need to exercise
judgment to determine when it is
appropriate to use the -59 modifier
indicating separate sessions. We do not
expect use of the modifier to be a
frequent occurrence.
Comment: Some commenters
expressed concern that the proposal
may create an incentive to bypass
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ultrasound and simply order an
advanced imaging procedure because, as
the lower cost modality, ultrasound
payment would be reduced. Another
commenter indicated that CMS was
proposing to include ultrasound under
the definition of advanced imaging
services for application of the MPPR,
noting that this conflicts with the
statutory definition of advanced imaging
services as MRI, CT, PET and nuclear
cardiology.
Response: Clearly, we do not intend
the MPPR to encourage radiologists to
forego ultrasound imaging in favor of
advanced imaging modalities. We trust
that radiologists will continue to utilize
the modality or modalities that is/are
both medically necessary and most
appropriate, rather than use payment
considerations to dictate the modality.
We believe the term ‘‘advanced
imaging’’ has confused commenters
because this term has been used to
define different sets of imaging services
for different Medicare initiatives. We
have not revised the definition of
advanced imaging services that we have
used for the imaging MPPR policy
regarding the TC of the second and
subsequent imaging services Since 2006,
for payment under the PFS, the imaging
MPPR for the TC has included CT, MRI
and ultrasound. While ultrasound
services are included in both the
existing imaging MPPR for the TC and
in the MPPR policy we are finalizing for
the PC beginning in CY 2012, we do not
consider ultrasound services to be
advanced imaging procedures for
purposes of accreditation. Section
135(a) of the Medicare Improvements
for Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110–275) required the
Secretary to designate organizations to
accredit suppliers, including but not
limited to physicians, non-physician
practitioners and Independent
Diagnostic Testing Facilities that furnish
the technical component (TC) of
advanced diagnostic imaging services,
which include MRI, CT, and nuclear
medicine imaging such as positron
emission tomography (PET). The MIPPA
provision expressly excludes
ultrasound, X-ray, and fluoroscopy from
this requirement.
Comment: Commenters indicated that
CMS’ proposed MPPR policy for the PC
would result in a payment reduction
that would adversely affect both the
quality of care and access to care; shift
imaging to hospitals; jeopardize the
integrated, community-based care
model; is counter-productive to the
concept of pay for quality performance;
and will encourage partial studies to be
done over several different visits, which
is inefficient for everyone involved and
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detrimental to patient care. Several
commenters did not condone such an
unprofessional response, but were
concerned that practitioners might begin
to circumvent this payment policy.
Response: We have no reason to
believe that appropriately valuing
services for payment under the PFS by
revising payment to reflect duplication
in the PC of multiple imaging services
would negatively impact quality of care;
jeopardize the integrated, communitybased care model; be counter-productive
to the concept of pay for quality
performance; or limit patients’ access to
medically reasonable and necessary
imaging services. We have no evidence
to suggest any of the adverse impacts
identified by the commenters have
resulted from the implementation of the
MPPR on the TC of imaging in 2006. In
fact, to the contrary, MedPAC’s analysis
in its June 2011 report indicates there
has been continued high annual growth
in the use of imaging.
With respect to the ordering and
scheduling of imaging services for
Medicare beneficiaries, we require that
Medicare-covered services be
appropriate to patient needs. We would
not expect the adoption of an MPPR for
the PC of imaging services to result in
imaging services being furnished on
separate days by one provider merely so
that the practitioner or provider may
garner increased payment. We agree
with the commenters who noted that
such an unprofessional response on the
part of practitioners would be inefficient
and inappropriate. We will continue to
monitor access to care and patterns of
delivery for imaging services, with
particular attention focused on
identifying any changes in the delivery
of same day imaging services that may
be clinically inappropriate.
Comment: Commenters maintained
that utilization of advanced imaging has
not declined since implementation of
the MPPRs or the OPPS cap because the
ordering physician has not been
impacted by MPPR payment policy.
Commenters indicated that in order to
address issues of over-utilization of
imaging services, it would be more
appropriate for CMS to address selfreferral issues rather than continue to
affect the payment for physicians
performing and interpreting imaging
studies through an MPPR or payment
cap methodology.
Response: We understand the
commenters’ concerns and will
continue to explore ways to
appropriately address overutilization.
We note that in addition to the
commmenters’ reference to physician
self-referral, in its June 2011 report,
MedPAC noted that numerous factors
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contribute to overutilization include
mispricing of services under the PFS.
In summary, after consideration of the
public comments received, we are
adopting our CY 2012 proposal to apply
an MPPR to the PC of advanced imaging
services, with a modification to apply a
25 percent reduction for CY 2012 rather
than the 50 percent reduction we had
proposed. We continue to believe that
efficiencies exist in the PC of multiple
imaging services, and we will continue
to monitor code combinations for
possible future adjustments to the
reduction percentage applied through
this MPPR policy.
Specifically, beginning in CY 2012 we
are adopting an MPPR that applies a 25
percent reduction to the PC of second
and subsequent advanced imaging
services furnished by the same
physician to the same patient, in the
same session, on the same day. We are
proposing to add CPT 74174 (Computed
tomographic angiography, abdomen and
pelvis; with contrast material(s),
including noncontrast images, if
performed, and image postprocessing),
which is a new code for CY 2012, to the
imaging MPPR list. This code is being
added on an interim final basis and is
open to public comment on this final
rule with comment period. We note that
the MPPR will apply when the
combined new procedure is furnished
in conjunction with another
procedure(s). The complete list of
services subject to the MPPR for the PC
of imaging services is the same as for the
MPPR currently applied to the TC of
imaging services, and is shown in
Addendum F. The PFS budget
neutrality provision is applicable to the
new MPPR for the PC of advanced
imaging services. Therefore, the
estimated reduced expenditures for
imaging services have been
redistributed to increase payment for
other PFS services. We refer readers to
section IX.C. of this final rule with
comment period for further discussion
of the impact of this policy.
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c. Further Expansion of MPPR Policies
Under Consideration for Future Years
Currently, the MPPR policies focus
only on a select number of codes. We
will be aggressively looking for
efficiencies in other sets of codes during
the coming years and will consider
implementing more expansive multiple
procedure payment reduction policies
in CY 2013 and beyond. In the proposed
rule, we invited public comment on the
following MPPR policies which are
under consideration. Any proposals
would be presented in future
rulemaking and subject to further public
comment:
• Apply the MPPR to the TC of All
Imaging Services. This approach would
apply a payment reduction to the TC of
the second and subsequent imaging
services performed in the same session.
Such an approach could define imaging
consistent with our existing definition
of imaging for purposes of the statutory
cap on payment at the OPPS rate
(including X-ray, ultrasound (including
echocardiography), nuclear medicine
(including positron emission
tomography), magnetic resonance
imaging, computed tomography, and
fluoroscopy, but excluding diagnostic
and screening mammography). Add-on
codes that are always furnished with
another service and have been valued
accordingly could be excluded.
Such an approach would be based on
the expected efficiencies due to
duplication of clinical labor activities,
supplies, and equipment time. This
approach would apply to approximately
530 HCPCS codes, including the 119
codes to which the current imaging
MPPR applies. Savings would be
redistributed to other PFS services as
required by the statutory PFS budget
neutrality provision.
• Apply the MPPR to the PC of All
Imaging Services. This approach would
apply a payment reduction to the PC of
the second or subsequent imaging
services furnished in the same
encounter. Such an approach could
define imaging consistent with our
existing definition of imaging for the
cap on payment at the OPPS rate. Add-
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on codes that are always furnished with
another service and have been valued
accordingly could be excluded.
This approach would be based on
efficiencies due to duplication of
physician work primarily in the preand post-service periods, with smaller
efficiencies in the intra-service period.
This approach would apply to
approximately 530 HCPCS codes,
including the 119 codes to which the
current imaging MPPR applies. Savings
would be redistributed to other PFS
services as required by the statutory PFS
budget neutrality provision.
• Apply the MPPR to the TC of All
Diagnostic Tests. This approach would
apply a payment reduction to the TC of
the second and subsequent diagnostic
tests (such as radiology, cardiology,
audiology, etc.) furnished in the same
encounter. Add-on codes that are
always furnished with another service
and have been valued accordingly could
be excluded.
The approach would be based on the
expected efficiencies due to duplication
of clinical labor activities, supplies, and
equipment time. The approach would
apply to approximately 700 HCPCS
codes, including the approximately 560
HCPCS codes subject to the OPPS cap.
The savings would be redistributed to
other PFS services as required by the
statutory PFS budget neutrality
provision.
We received several comments
concerning the future expansion of the
MPPR. We will take the comments
under consideration as we develop
future proposals. Any proposals would
be presented in future rulemaking and
subject to further public comment.
d. Procedures Subject to the OPPS Cap
We are proposing to add the new
codes in Table 9 to the list of procedures
subject to the OPPS cap, effective
January 1, 2012. These procedures meet
the definition of imaging under section
5102(b) of the DRA. These codes are
being added on an interim final basis
and are open to public comment in this
final rule with comment period.
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C. Overview of the Methodology for the
Calculation of Malpractice RVUs
Section 1848(c) of the Act requires
that each service paid under the PFS be
comprised of three components: work,
PE, and malpractice. From 1992 to 1999,
malpractice RVUs were charge-based,
using weighted specialty-specific
malpractice expense percentages and
1991 average allowed charges.
Malpractice RVUs for new codes after
1991 were extrapolated from similar
existing codes or as a percentage of the
corresponding work RVU. Section
4505(f) of the BBA amended section
1848(c) of the Act which required us to
implement resource-based malpractice
RVUs for services furnished beginning
in 2000. Therefore, initial
implementation of resource-based
malpractice RVUs occurred in 2000.
The statute also requires that we
review, and if necessary adjust, RVUs
no less often than every 5-years. The
first review and update of resourcebased malpractice RVUs was addressed
in the CY 2005 PFS final rule with
comment period (69 FR 66263). Minor
modifications to the methodology were
addressed in the CY 2006 PFS final rule
with comment period (70 FR 70153). In
the CY 2010 PFS final rule with
comment period, we implemented the
second review and update of
malpractice RVUs. For a discussion of
the second review and update of
malpractice RVUs, see the CY 2010 PFS
proposed rule (74 FR 33537) and final
rule with comment period (74 FR
61758).
As explained in the CY 2011 PFS final
rule with comment period, malpractice
RVUs for new and revised codes
effective before the next Five-Year
Review of Malpractice (for example,
effective CY 2011 through CY 2014,
assuming that the next review of
malpractice RVUs occurs for CY 2015)
are determined either by a direct
crosswalk to a similar source code or by
a modified crosswalk to account for
differences in work RVUs between the
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new/revised code and the source code
(75 FR 73208). For the modified
crosswalk approach, we adjust (or
‘‘scale’’) the malpractice RVU for the
new/revised code to reflect the
difference in work RVU between the
source code and the new/revised work
value (or, if greater, the clinical labor
portion of the fully implemented PE
RVU) for the new code. For example, if
the proposed work RVU for a revised
code is 10 percent higher than the work
RVU for its source code, the malpractice
RVU for the revised code would be
increased by 10 percent over the source
code RVU. This approach presumes the
same risk factor for the new/revised
code and source code but uses the work
RVU for the new/revised code to adjust
for risk-of-service.
D. Geographic Practice Cost Indices
(GPCIs)
1. Background
Section 1848(e)(1)(A) of the Social
Security Act requires us to develop
separate Geographic Practice Cost
Indices (GPCIs) to measure resource cost
differences among localities compared
to the national average for each of the
three fee schedule components (that is,
physician work, practice expense (PE),
and malpractice). While requiring that
the PE and malpractice GPCIs reflect the
full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that
the physician 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 beginning January 1,
2011.
Section 1848(e)(1)(E) of the Act
provides for a 1.0 floor for the work
GPCIs which was set to expire at the
end of 2009 until it was extended
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through December 31, 2010 by section
3102(a) of the Affordable Care Act.
Because the work GPCI floor was set to
expire at the end of 2010, the GPCIs
published in Addendum E of the CY
2011 PFS final rule with comment
period did not reflect the 1.0 physician
work floor. However, section
1848(e)(1)(E) of the Act was amended on
December 15, 2010, by section 103 of
the Medicare and Medicaid Extenders
Act (MMEA) of 2010 (P.L. 111–309) to
extend the 1.0 work GPCI floor through
December 31, 2011. Appropriate
changes to the CY 2011 GPCIs were
made to reflect the 1.0 physician work
floor required by section 103 of the
MMEA. Since the work GPCI floor
provided in section 1848(e)(1)(E) of the
Act is set to expire prior to the
implementation of the CY 2012 PFS, the
CY 2012 physician work GPCIs, and
summarized geographic adjustment
factors (GAFs), presented in this final
rule with comment period do not reflect
the 1.0 work GPCI floor. As required by
section 1848(e)(1)(G) and section
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 will be
applicable in CY 2012. Moreover, the
limited recognition of cost differences in
employee compensation and office rent
for the PE GPCIs, and the related hold
harmless provision, required under
section 1848(e)(1)(H) of the Act was
only applicable for CY 2010 and CY
2011 (75 FR 73253) and, therefore, is no
longer effective beginning in CY 2012.
Section 1848(e)(1)(C) of the Act
requires us to review and, if necessary,
adjust the GPCIs not less often than
every 3 years. This section also specifies
that if more than 1 year has elapsed
since the last GPCI revision, we must
phase in the adjustment over 2 years,
applying only one-half of any
adjustment in the first year.
As noted in the CY 2011 PFS final
rule with comment period (75 FR 73252
through 73262), for the sixth GPCI
update, we updated the data used to
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compute all three GPCI components.
Specifically, we utilized the 2006
through 2008 Bureau of Labor Statistics
(BLS) Occupational Employment
Statistics (OES) data to calculate the
physician work GPCIs (75 FR 73252). In
addition, we used the 2006 through
2008 BLS OES data to calculate the
employee compensation sub-component
of practice expense (75 FR 73255).
Consistent with previous updates, we
used the 2 bedroom residential
apartment rent data from HUD (2010) at
the 50th percentile as a proxy for the
relative cost differences in physician
office rents (75 FR 73256). Lastly, we
calculated the malpractice GPCIs using
malpractice premium data from 2006
through 2007 (75 FR 73256).
Since more than 1-year had elapsed
since the fifth GPCI update, as required
by law, the sixth GPCI update changes
are being phased in over a 2-year period.
The current CY 2011 GPCIs reflect the
first year of the transition. The final CY
2012 GPCIs reflect the full
implementation with modifications
reflecting the revisions contained in this
final rule with comment period.
The Affordable Care Act requires that
we analyze the current methodology
and data sources used to calculate the
PE GPCI component. Specifically,
section 1848(e)(1)(H)(iv) of the Act (as
added by section 3102(b) of the
Affordable Care Act) requires the
Secretary to ‘‘analyze current methods
of establishing practice expense
adjustments under subparagraph (A)(i)
and evaluate data that fairly and reliably
establishes distinctions in the cost of
operating a medical practice in different
fee schedule areas.’’ Section
1848(e)(1)(H)(iv) of the Act also requires
that such analysis shall include an
evaluation of the following:
• The feasibility of using actual data
or reliable survey data developed by
medical organizations on the costs of
operating a medical practice, including
office rents and non-physician staff
wages, in different fee schedule areas.
• The office expense portion of the
practice expense geographic adjustment;
including the extent to which types of
office expenses are determined in local
markets instead of national markets.
• The weights assigned to each area
of the categories within the practice
expense geographic adjustment.
In addition, the weights for different
categories of practice expense in the
GPCIs have historically matched the
weights developed by the CMS Office of
the Actuary (OACT) for use in the
Medicare Economic Index (MEI), the
measure of inflation used as part of the
basis for the annual update to the
physician fee schedule payment rates.
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In response to comments received on
the CY 2011 Physician Fee Schedule
proposed rule, however, we delayed
moving to the new MEI weights
developed by OACT for CY 2011
pending further analysis.
Lastly, we asked the Institute of
Medicine (IOM) to evaluate the accuracy
of the geographic adjustment factors
used for Medicare physician payment.
IOM will prepare two reports for the
Congress and the Secretary of the
Department of Health and Human
Services. The revised first report (Phase
I), which includes supplemental
recommendations to the initial IOM
release of June1, 2011, was released on
September 28, 2011, and includes an
evaluation of the accuracy of geographic
adjustment factors for the hospital wage
index and the GPCIs, and the
methodology and data used to calculate
them. The second report, expected in
spring 2012, will evaluate the effects of
the adjustment factors on the
distribution of the health care
workforce, quality of care, population
health, and the ability to provide
efficient, high value care. Given the
timing of the release of IOM’s revised
report, we are unable to address the full
scope of the IOM recommendations in
this final rule with comment period.
These reports can be accessed on the
IOM’s Web site at: https://www.iom.edu/
Reports/2011/Geographic-Adjustmentin-Medicare-Payment-Phase-IImproving-Accuracy.aspx.
The recommendations that relate to or
would have an effect on the GPCIs
included in IOM’s revised Phase I report
are summarized as follows:
• Recommendation 2–1: The same
labor market definition should be used
for both the hospital wage index and the
physician geographic adjustment factor.
Metropolitan statistical areas and
Statewide non-metropolitan statistical
areas should serve as the basis for
defining these labor markets.
• Recommendation 2–2: The data
used to construct the hospital wage
index and the physician geographic
adjustment factor should come from all
health care employers.
• Recommendation 5–1: The GPCI
cost share weights for adjusting fee-forservice payments to practitioners should
continue to be national, including the
three GPCIs (work, practice expense,
and liability insurance) and the
categories within the practice expense
(office rent and personnel).
• Recommendation 5–2: Proxies
should continue to be used to measure
geographic variation in the physician
work adjustment, but CMS should
determine whether the seven proxies
currently in use should be modified.
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• Recommendation 5–3: CMS should
consider an alternative method for
setting the percentage of the work
adjustment based on a systematic
empirical process.
• Recommendation 5–4: The practice
expense GPCI should be contructed
with the full range of occupations
employed in physicians’ offices, each
with a fixed national weight based on
the hours of each occupation employed
in physicians’ offices nationwide.
• Recommendation 5–5: CMS and the
Bureau of Labor Statistics should
develop an agreement allowing the
Bureau of Labor Statistics to analyze
confidential data for the Centers for
Medicare and Medicaid Services.
• Recommendation 5–6: A new
source of information should be
developed to determine the variation in
the price of commercial office rent per
square foot.
• Recommendation 5–7: Nonclinical
labor-related expenses currently
included under practice expense office
expenses should be geographically
adjusted as part of the wage component
of the practice expense.
2. GPCI Revisions for CY 2012
The revised GPCI values we proposed
were developed by a CMS contractor. As
mentioned previously, there are three
GPCI components (physician work, PE,
and malpractice), and all GPCIs are
developed through comparison to a
national average for each component.
Additionally, each of the three GPCIs
relies on its own data source(s) and
methodology for calculating its value.
As discussed in more detail later in this
section, we proposed to revise the PE
GPCIs for CY 2012, as well as the cost
share weights which correspond to all
three GPCIs.
a. Physician Work GPCIs
The physician work GPCIs are
designed to capture the relative cost of
physician labor by Medicare PFS
locality. Previously, the physician work
GPCIs were developed using the median
hourly earnings from the 2000 Census of
workers in seven professional specialty
occupation categories which we used as
a proxy for physicians’ wages.
Physicians’ wages are not included in
the occupation categories because
Medicare payments are a key
determinant of physicians’ earnings.
That is, including physicians’ wages in
the physician work GPCIs would, in
effect, have made the indices dependent
upon Medicare payments. As required
by law, the physician work GPCI reflects
one quarter of the relative wage
differences for each locality compared
to the national average.
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The physician work GPCI updates in
CYs 2001, 2003, 2005, and 2008 were
based on professional earnings data
from the 2000 Census. For the sixth
GPCI update in CY 2011, we used the
2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational
Employment Statistics (OES) data as a
replacement for the 2000 Census data.
We did not propose to revise the
physician work GPCI data source for CY
2012. However, we note that the work
GPCIs will be revised to account for the
expiration of the statutory work floor.
The 1.5 work floor for Alaska is
permanent and will be applicable in CY
2012. In addition, we proposed to revise
the physician work cost share weight
from 52.466 to 48.266 in line with the
2011 MEI weights, which are based on
2006 data (referred to hereinafter as the
2006-based MEI).
b. Practice Expense GPCIs
(1) Affordable Care Act Analysis and
Revisions for PE GPCIs
(A) General Analysis for the CY 2012
PE GPCIs
As previously mentioned, section
1848(e)(1)(H)(iv) of the Act (as added by
section 3102(b) of the Affordable Care
Act) requires the Secretary to ‘‘analyze
current methods of practice expense
adjustments under subparagraph (A)(i)
and evaluate data that fairly and reliably
establishes distinctions in the cost of
operating a medical practice in the
different fee schedule areas.’’
Moreover, section 1848 (e)(1)(H)(v) of
the Act requires the Secretary to make
appropriate adjustments to the PE GPCIs
as a result of the required analysis, no
later than January 1, 2012. We proposed
to make four revisions to the PE data
sources and cost share weights
discussed herein effective January 1,
2012. Specifically, we proposed to: (1)
Revise the occupations used to calculate
the employee wage component of PE
using BLS wage data specific to the
office of physicians’ industry; (2) utilize
two bedroom rental data from the 2006–
2008 American Community Survey as
the proxy for physician office rent; (3)
create a purchased service index that
accounts for regional variation in labor
input costs for contracted services from
industries comprising the ‘‘all other
services’’ category within the MEI office
expense and the stand alone ‘‘other
professional expenses’’ category of the
MEI; and (4) use the 2006-based MEI
(most recent MEI weights finalized in
the CY 2011 final rule with comment
period) to determine the GPCI cost share
weights. These proposals were based on
analyses we conducted to address
commenter concerns in the CY 2011
final rule with comment period and a
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continuation of our PE evaluation as
required by the Affordable Care Act.
The main comments were related to: (1)
the occupational groups used to
calculate the employee wage component
of PE, and (2) concerns by commenters
stating that regional variation in
purchased services such as legal and
accounting were not sufficiently
included in the GPCI methodology.
We began analyzing the current
methods and data sources used in the
establishment of the PE GPCIs during
the CY 2011 rulemaking process (75 FR
40084). With respect to our CY 2011
analysis, we began with a review of the
Government Accountability Office’s
(GAO) March 2005 Report entitled,
‘‘Medicare Physician Fees: Geographic
Adjustment Indices Are Valid in Design,
but Data and Methods Need
Refinement’’ (GAO–05–119). While we
have raised concerns in the past about
some of the GAO’s GPCI
recommendations, we noted that with
respect to the PE GPCIs, the GAO did
not indicate any significant issues with
the methods underlying the PE GPCIs.
Rather, the report focused on some of
the data sources used in the method. For
example, the GAO stated that the wage
data used for the PE GPCIs are not
current. Similarly, commenters on
previous PE GPCI updates
predominantly focused on either the
data sources used in the method or
raised issues such as incentivizing the
provision of care in different geographic
areas. However, the latter issue
(incentivizing the provision of care) is
outside the scope of the statutory
requirement that the PE GPCIs reflect
the relative costs of the mix of goods
and services comprising practice
expenses in the different fee schedule
areas relative to the national average.
To further analyze the PE office
expense in accordance with section
1848(e)(1)(H)(iv) of the Act, we
examined the following issues: the
appropriateness of expanding the
number of occupations included in the
employee wage index; the
appropriateness of replacing rental data
from the Department of Housing and
Urban Development (HUD) with data
from the 2006–2008 American
Community Survey (ACS) two bedroom
rental data as a proxy for the office rent
subcomponent of PE; and the
appropriateness of adjusting the ‘‘all
other services’’ and ‘‘other professional
expenses’’ MEI categories for geographic
variation in labor-related costs. We also
examined available ACS occupational
group data for potential use in
determining geographic variation in the
employee wage component of PE.
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73083
An additional component of the
analysis under section 1848(e)(1)(H)(iv)
of the Act is to evaluate the weights
assigned to each of the categories within
the practice expense geographic
adjustment. As discussed in the CY
2011 final rule with comment period (75
FR 73256), in response to concerns
raised by commenters and to allow us
time to conduct additional analysis, we
did not revise the GPCI cost share
weights to reflect the weights used in
the revised and rebased 2006 MEI that
we adopted beginning in CY 2011. In
response to those commenters who
raised many points regarding the
appropriateness of assigning laborrelated costs in the medical equipment
and supplies and miscellaneous
component which do not reflect locality
cost differentials, we agreed to address
the GPCI cost share weights again in the
CY 2012 PFS proposal. These issues are
discussed in greater detail in section
II.D.2.b.(1).(E). of this final rule with
comment period that discusses our
determination of the cost share weights.
We also stated in the CY 2011 final
rule with comment period that we
would review the findings of the
Secretary’s Medicare Geographic
Payment Summit and the MEI technical
advisory panel during future rulemaking
(75 FR 73256). The Secretary convened
the National Summit on Health Care
Quality and Value on October 4, 2010.
This Summit was attended by a number
of policy experts that engaged in
detailed discussions regarding
geographic adjustment factors and
geographic variation in payment and the
promotion of high quality care. This
National Summit was useful by
informing us on issues that we are
studying further through two Institute of
Medicine studies. In accordance with
section 3102(b) of the Affordable Care
Act, we are also continuing to consider
these issues in the course of this notice
and comment rulemaking for the CY
2012 PFS, which includes revisions to
the GPCI, and through preparation of a
report to the Congress that we will be
submitting later this year in accordance
with section 3137(b) of the Affordable
Care Act on a plan for reforming the
hospital wage index. In addition, we
announced the establishment of the MEI
Technical Advisory Panel and request
for nominations of members on October
7, 2011 (76 FR 62415 through 62416).
We note that the panel will conclude by
September 28, 2012 and we look
forward to examining the
recommendations of this panel once it
has issued its report.
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(B) Analysis of ACS Rental Data
In the CY 2011 final rule with
comment period, we finalized our
policy to use the 2010 Fair Market Rent
(FMR) data produced by HUD at the
50th percentile as the proxy for relative
cost differences in physician office
rents. However, as part of our analysis
required by section 1848(e)(1)(H)(iv) of
the Act, we have now examined the
suitability of utilizing 3-year (2006–
2008) ACS rental data to serve as a
proxy for physician office rents. We
believe that the ACS rental data provide
a sufficient degree of reliability and are
an appropriate source on which to base
our PE GPCI office rent proxy. We also
believe that the ACS data provide a
higher degree of accuracy than the HUD
data since the ACS data are updated
annually and not based on data
collected by the 2000 Census long form.
Moreover, it is our understanding that
the Census ‘‘long form,’’ which is
utilized to collect the necessary base
year rents for the HUD Fair Market Rent
(FMR) data, will no longer be available
in future years. Therefore, we proposed
to use the available 2006 through 2008
ACS rental data for two bedroom
residential units as the proxy for
physician office rent. We also sought
comment regarding the potential use of
5-year ACS rental data as a proxy for
physician office rent in future
rulemaking.
We believe the ACS data will more
accurately reflect geographic variation
in the office rent component. As in past
GPCI updates, we proposed to apply a
nationally uniform weight to the office
rent component. We proposed to use the
2006-based MEI weight for fixed capital
and utilities as the weight for the office
rent category in the PE GPCI, and to use
the ACS residential rent data to develop
the practice expense GPCI value.
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(C) Employee Wage Analysis
Accurately evaluating the relative
price that physicians pay for labor
inputs requires both a mechanism for
selecting the occupations to include in
the employee wage index and
identifying an accurate measure of the
wages for each occupation. We received
comments during the CY 2011
rulemaking cycle noting that the current
employee wage methodology may omit
key occupational categories for which
cost varies significantly across regions.
Commenters suggested including
occupations such as accounting, legal,
and information technology in the
employee wage component of the PE
GPCI. To address these concerns, we
proposed to revise the employee wage
index framework within the practice
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expense (PE) GPCI. Under this new
methodology, we would only select
occupational categories relevant to a
physician’s practice. We would use a
comprehensive set of wage data from
the Bureau of Labor Statistics
Occupational Employment Statistics
(BLS OES) specific to the offices of
physicians industry. Utilizing wage and
national cost share weight data from the
BLS OES would not only provide a
more systematic approach to
determining which occupations should
be included in the non-physician
employee wage category of the PE GPCI,
but would also enable us to determine
how much weight each occupation
should receive within the index.
Due to its reliability, public
availability, level of detail, and national
scope, we proposed to use BLS OES
data to estimate both occupation cost
shares and hourly wages for purposes of
determining the non-physician
employee wage component of the PE
GPCI. The OES panel data are collected
from approximately 200,000
establishments, and provide
employment and wage estimates for
about 800 occupations. At the national
level, OES provides estimates for over
450 industry classifications (using the 3,
4, and 5 digit North American Industry
Classification System (NAICS)),
including the Offices of Physicians
industry (NAICS 621100). As described
in the census, the Offices of Physicians
industry comprises establishments of
health practitioners having the degree of
M.D. (Doctor of Medicine) or D.O.
(Doctor of Osteopathy) primarily
engaged in the independent practice of
general or specialized medicine (except
psychiatry or psychoanalysis) or
surgery. These practitioners operate
private or group practices in their own
offices (such as centers, clinics) or in the
facilities of others (such as hospitals or
Health Maintenance Organization
(HMO) medical centers). The OES data
provide significant detail on
occupational categories and offer
national level cost share estimates for
the offices of physicians industry.
In the BLS OES data methodology, we
weighted each occupation based on its
share of total labor cost within the
offices of physician industry.
Specifically, each occupation’s weight is
proportional to the product of its
occupation’s employment share and
average hourly wage. In this calculation,
we used each occupation’s employment
level rather than hours worked, because
the BLS OES does not contain industryspecific information describing the
number of hours worked in each
occupation (see: https://www.bls.gov/oes/
current/naics4_621100.htm). Our
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proposed methodology accounted for 90
percent of the total wage share in the
office of physicians industry.
Additionally, our proposed strategy
produced 33 individual occupations
that accounted for many of the
occupations commenters had stated
were historically excluded from the
employee wage calculation (for
example, accounting, auditors, and
medical transcriptionists).
We also evaluated available ACS
occupational data as a potential data
source for the non-physician employee
wage PE GPCI subcomponent. Based on
the occupations currently used to
calculate employee wages, the BLS OES
captures occupations with greater
relevancy to physician office practices
and is a more appropriate data source
than the currently available ACS data.
In addition, since our publication of the
CY 2012 proposed rule, we have
conducted an analysis of ACS wage data
including an expanded mix of
occupations. A review of this analysis
can be found in our contractors
‘‘Revisions to the Sixth Update of the
Geographic Practice Cost Index: Final
Report’’ located on the physician fee
schedule CY 2012 final rule with
comment period Web site at: https://
www.cms.gov/PhysicianFeeSched/.
After careful analysis, we still believe
that the BLS OES data provide for the
most accurate and comprehensive
measurement of physician nonphysician employee wages.
(D) Purchased Services Analysis
For CY 2012, we proposed to
geographically adjust the labor-related
industries within the ‘‘all other
services’’ and ‘‘other professional
expenses’’ categories of the MEI. In
response to commenters who stated that
these purchased services were laborrelated and should be adjusted
geographically, we agreed to examine
this issue further in the CY 2011 final
rule with comment period and refrained
from making any changes. Based on our
subsequent examination of this issue,
we believe it would be appropriate to
geographically adjust for the laborrelated component of purchased
services within the ‘‘All Other Services’’
and ‘‘Other Professional Expenses’’
categories using BLS wage data. In total,
there are 63 industries, or cost
categories, accounted for within the ‘‘all
other services’’ and ‘‘other professional
services’’ categories of the 2006-based
MEI. For purposes of the hospital wage
index at 74 FR 43845, we defined a cost
category as labor-related if the cost
category is defined as being both labor
intensive and its costs vary with, or are
influenced by the local labor market.
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The total purchased services component
accounts for 8.095 percent of total
practice cost. However, only 5.011
percentage points (of the total 8.095
percentage points assigned to purchased
services) are defined as labor-related
and thus adjusted for locality cost
differences. These 5.011 percentage
points represent cost categories that we
believe are labor intensive and have
costs that vary with, or are influenced
by, the local labor market. The laborrelated cost categories include but are
not limited to building services (such as
janitorial and landscaping), security
services, and advertising services. The
remaining weight assigned to the non
labor-related industries (3.084
percentage points) represent industries
that do not meet the criteria of being
labor intensive or having their costs
vary with the local labor market.
In order to calculate the labor-related
and non labor- related shares, we would
use a similar methodology that is
employed in estimating the labor-related
share of various CMS market baskets. A
more detailed explanation of this
methodology can be found under the
supporting documents section of the CY
2012 PFS final rule with comment
period Web page at https://www.cms.gov/
PhysicianFeeSched/.
We believe our analysis, during 2010
and this year, of the current methods of
establishing PE GPCIs and our
evaluation of data that fairly and
reliably establish distinctions in the cost
of operating a medical practice in the
different fee schedule areas meet the
statutory requirements of section
1848(e)(1)(H)(iv) of the Act. A more
detailed discussion of our analysis of
current methods of establishing PE
GPCIs and evaluation of data sources is
included in our contractor’s draft report
entitled, ‘‘Proposed Revisions to the
Sixth Update of the Geographic Practice
Cost Index.’’ Our contractor’s final
report and associated analysis of the
GPCI revisions, including the PE GPCIs,
will be made publicly available on the
CMS Web site. The final report may be
accessed from the PFS Web site at:
https://www.cms.gov/
PhysicianFeeSched/ under the
‘‘Downloads’’ section of the CY 2012
PFS final rule with comment period
Web page.
Additionally, see section IX.F. of this
final rule with comment period for
Table 86, which reflects the GAF
impacts resulting from these proposals.
As the table demonstrates, the primary
driver of the CY 2012 impact is the
expiration of the work GPCI floor which
had produced non budget-neutral
increases to the CY 2011 GPCIs for
lower cost areas as authorized under the
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Affordable Care Act the Medicare and
Medicaid Extenders Act (MMEA).
(E) Determining the PE GPCI Cost Share
Weights
To determine the cost share weights
for the CY 2012 GPCIs, we proposed to
use the weights established in the 2006based MEI. The MEI was rebased and
revised in the CY 2011 final rule with
comment period to reflect the weightedaverage annual price change for various
inputs needed to provide physicians’
services. As discussed in detail in that
section (75 FR 73262 through 73277),
the proposed expense categories in the
MEI, along with their respective
weights, were primarily derived from
data collected in the 2006 AMA PPIS for
self-employed physicians and selected
self-employed non-medical doctor
specialties. Since we have historically
updated the GPCI cost share weights
consistent with the most recent update
to the MEI, and because we have
addressed commenter concerns
regarding the inclusion of the weight
assigned to utilities with office rent and
geographically adjusted for the labor
intensive industries within the ‘‘all
other services’’ and ‘‘other professional
expenses’’ MEI categories, we believe it
is appropriate to adopt the 2006-based
MEI cost share weights.
(i) Practice Expense
For the cost share weight for the CY
2012 PE GPCIs, we used the 2006-based
MEI weight for the PE category of 51.734
percent minus the professional liability
insurance category weight of 4.295
percent. Therefore, we proposed a cost
share weight for the PE GPCIs of 47.439
percent.
(ii) Employee Compensation
For the employee compensation
portion of the PE GPCIs, we proposed to
use the non-physician employee
compensation category weight of 19.153
percent reflected in the 2006-based MEI.
(iii) Office Rent
We proposed that the weight for the
office rent component be revised from
12.209 percent to 10.223 percent. The
12.209 percent office rent GPCI weight
was set equal to the 2000-based MEI
cost weight for office expenses, which
was calculated using the American
Medical Association’s (AMA)
Socioeconomic Monitoring Survey
(SMS). The 12.209 percent reflected the
expenses for rent, depreciation on
medical buildings, mortgage interest,
telephone, and utilities. We proposed to
set the GPCI office rent equal to 10.223
percent reflecting the 2006-based MEI
cost weights (75 FR 73263) for fixed
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capital (reflecting the expenses for rent,
depreciation on medical buildings and
mortgage interest) and utilities. We are
no longer including telephone costs in
the GPCI office rent cost weight because
we believe these expenses do not vary
by geographic area.
Consistent with the revised and
rebased 2006-based MEI which was
adopted in the CY 2011 final rule with
comment period (75 FR 73263), we
disaggregated the broader office
expenses component for the PE GPCI
into 10 new cost categories. In this
disaggregation, the fixed capital
component is the office expense
category applicable to the office rent
component of the PE GPCI. As
discussed in the section dealing with
office rent, we proposed to use 2006–
2008 ACS rental data as the proxy for
physician office rent. These data
represent a gross rent amount and
includes data on utilities expenditures.
Since it is not possible to separate the
utilities component of rent for all ACS
survey respondents, it was necessary to
combine these two components to
calculate office rent and by extension,
we proposed combining those two cost
categories when assigning a weight to
the office rent component.
(iv) Purchased Services
As discussed in the previous
paragraphs, a new purchased services
index was created to geographically
adjust the labor-related components of
the ‘‘All Other Services’’ and ‘‘Other
Professional Expenses’’ categories of the
2006-based MEI office market basket. In
order to calculate the purchased
services index, we proposed to merge
the corresponding weights of these two
categories to form a combined
purchased services weight of 8.095
percent. However, we proposed to only
adjust for locality cost differences of the
labor-related share of the industries
comprising the ‘‘All Other Services’’
and ‘‘Other Professional Expenses’’
categories. We have determined that
only 5.011 percentage points of the
8.095 percentage points would be
adjusted for locality cost differences
(5.011 adjusted purchased service +
3.084 non-adjusted purchased services =
8.095 total cost share weight).
(v) Equipment, Supplies, and Other
Miscellaneous Expenses
To calculate the proposed medical
equipment, supplies, and other
miscellaneous expenses component, we
removed professional liability (4.295
percentage points), non-physician
employee compensation (19.153
percentage points), fixed capital/utilities
(10.223 percentage points), and
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purchased services (8.095 percentage
points) from the PE category weight
(51.734 percent). Therefore, we
proposed a cost share weight for the
medical equipment, supplies, and other
miscellaneous expenses component of
9.968 percent. Consistent with previous
methodology, this component of the PE
GPCI is not adjusted for geographical
variation.
(vi) Physician Work and Malpractice
GPCIs
Furthermore, we proposed to use the
physician compensation cost category
(F) PE GPCI Floor for Frontier States
frontier States effective January 1, 2011.
In accordance with section 1848(e)(1)(I)
of the Act, beginning in CY 2011, we
applied a 1.0 PE GPCI floor for
physicians’ services furnished in States
determined to be frontier States. There
are no changes to those States identified
as ‘‘Frontier States’’ for the CY 2012
final rule with comment period. The
qualifying States are reflected in Table
11. In accordance with statute, we will
apply a 1.0 GPCI floor for these States
in CY 2012.
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GPCI cost share weights and how the
weights account for local and national
adjustments, see our contractor’s
‘‘Proposed Revisions to the Sixth
Update of the Geographic Practice Cost
Index’’ draft report at (https://
www.cms.gov/PhysicianFeeSched/). In
addition, information regarding the CY
2011 update to the MEI can be reviewed
beginning on 75 FR 73262.
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Section 10324(c) of the Affordable
Care Act added a new subparagraph (I)
under section 1848(e)(1) of the Act to
establish a 1.0 PE GPCI floor for
physicians’ services furnished in
weight of 48.266 percent as the work
GPCI cost share weight; and we
proposed to use the professional
liability insurance weight of 4.295
percent for the malpractice GPCI cost
share weight. We believe our analysis
and evaluation of the weights assigned
to each of the categories within the PE
GPCIs satisfies the statutory
requirements of section 1848(e)(1)(H)(iv)
of the Act.
The cost share weights for the CY
2012 GPCIs are displayed in Table 10.
For a detailed discussion regarding the
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(2) Summary of CY 2012 PE GPCI
Proposal
The PE GPCIs include four
components: employee compensation,
office rent, purchased services, and
medical equipment, supplies and
miscellaneous expenses. Our proposals
relating to each of these components are
as follows:
• Employee Compensation: We
proposed to geographically adjust the
employee compensation using the 2006
through 2008 BLS OES data specific to
the offices of physicians industry along
with nationwide wage data to determine
the employee compensation component
of the PE GPCIs. The employee
compensation component accounts for
19.153 percent of total practice costs or
40.4 percent of the total PE GPCIs.
• Office Rents: We proposed to
geographically adjust office rent using
the 2006 through 2008 ACS residential
rental data for two bedroom units as a
proxy for the relative cost differences in
physician office rents. In addition, we
proposed to consolidate the utilities into
the office rent weight to account for the
utility data present in ACS gross rent
data. The office rent component
accounts for 10.223 percent of total
practice cost or 21.5 percent of the PE
GPCIs.
• Purchased Services: We proposed to
geographically adjust the labor-related
component of purchased services within
the ‘‘All Other Services’’ and ‘‘Other
Professional Expenses ‘‘categories using
BLS wage data. The methodology
employed to estimate purchased
services expenses is based on the same
data used to estimate the employee
wage index. Specifically, the purchased
services framework relies on BLS OES
wage data to estimate the price of labor
in industries that physician offices
frequently rely upon for contracted
services. As previously mentioned, the
labor-related share adjustment for each
industry was derived using a similar
methodology as is employed for
estimating the labor-related shares of
CMS market baskets. Furthermore, the
weight assigned to each industry within
the purchased services index was based
on the 2006-based MEI. A more detailed
discussion regarding CMS market
baskets, as well as the corresponding
definitions of a ‘‘labor-related share’’
and a ‘‘non-labor-related share’’ can be
viewed at (74 FR 43845). The total
purchased services component accounts
for 8.095 percent of total practice cost or
17.1 percent of the PE GPCI. However,
the proportion of purchased services
that is geographically adjusted for
locality cost difference is 5.011
percentage points of the 8.095
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percentage points or 10.6 percent of the
PE GPCI.
• Medical Equipment, Supplies, and
other Miscellaneous Expenses: We
continue to believe that items such as
medical equipment and supplies have a
national market and that input prices do
not vary appreciably among geographic
areas. As discussed in previous GPCI
updates in the CY 2008 and CY 2011
PFS proposed rules, specifically the
fifth GPCI update (72 FR 38138) and
sixth GPCI update (75 FR 73256),
respectively, some price differences may
exist, but we believe these differences
are more likely to be based on volume
discounts rather than on geographic
market differences. For example, large
physicians’ practices may utilize more
medical equipment and supplies and
therefore may or may not receive
volume discounts on some of these
items. To the extent that such
discounting may exist, it is a function of
purchasing volume and not geographic
location. The medical equipment,
supplies, and miscellaneous expenses
component was factored into the PE
GPCIs with a component index of 1.000.
The medical equipment, supplies, and
other miscellaneous expense component
account for 9.968 percent of total
practice cost or 21.0 percent of the PE
GPCI.
c. Malpractice GPCIs
The malpractice GPCIs are calculated
based on insurer rate filings of premium
data for $1 million to $3 million mature
‘‘claims-made’’ policies (policies for
claims made rather than services
furnished during the policy term). We
chose claims-made policies because
they are the most commonly used
malpractice insurance policies in the
United States. We used claims-made
policy rates rather than occurrence
policies because a claims-made policy
covers physicians for the policy amount
in effect when the claim is made,
regardless of the date of event in
question; whereas an occurrence policy
covers a physician for the policy
amount in effect at the time of the event
in question, even if the policy is
expired. Based on the data we analyzed,
we proposed to revise the cost share
weight for the malpractice GPCI from
3.865 percent to 4.295 percent.
d. Public Comments and CMS
Responses Regarding the CY 2012
Proposed Revisions to the 6th GPCI
Update
We received many public comments
regarding the CY 2012 proposed GPCIs.
Summaries of the comments and our
responses follow.
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Employee Compensation
Comment: Most commenters agreed
with CMS’ proposal to expand the
occupations used to calculate the nonphysician employee wage portion of the
PE GPCI since the updated occupations
better reflect the occupations found in
physician practices. Many commenters
indicated that BLS was the most
appropriate data source since it
represents the most current data
available. Several commenters agreed
with IOM’s recommendation to include
the full range of occupations employed
in physicians’ offices (100 percent of
total non-physician wage share) from
the BLS data, rather than the
occupations representing 90 percent of
the total non-physician wage share that
we proposed. A few commenters did not
support the use of BLS data since they
do not include data describing the
number of hours worked. A few
commenters who provide radiation
oncology services recommended adding
the salaries of medical physicists to the
non-physician employee compensation
calculation based on wage data from the
American Association of Physicists in
Medicine or the American Academy of
Pain Medicine. Some commenters
indicated the occupational weights
utilized by CMS are not representative
of their actual practices or the Medical
Group Management Association
(MGMA) data.
Response: We agree with the
commenters who indicated that the BLS
is the most current and appropriate data
source and disagree with the
commenters who did not support the
use of BLS data since it does not include
data describing the number of hours
worked. We believe that the BLS data
provide the necessary detail on
occupational categories and offer
national level cost share estimates for
the offices of physicians industry. In
addition, as IOM noted in its report:
‘‘The committee finds that independent,
health-care specific data from the BLS
provide the most conceptually
appropriate measure of differences in
wages for health professional labor and
clinical and administrative office staff.’’
(Geographic Adjustment in Medicare
Payment: Phase I: Improving Accuracy,
pp. 5–34, available at https://
www.iom.edu/Reports/2011/
Geographic-Adjustment-in-MedicarePayment-Phase-I-ImprovingAccuracy.aspx.)
We also agree with commenters who
stated that the updated occupations
better reflect the occupations found in
physician practices and those who
indicated we should expand the
occupations to include the full range of
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occupations employed in physician
offices as recommended by IOM. As
IOM noted in its report, ‘‘the expansion
of occupations will be a better reflection
of the current workforce and a broader
range of health professions, which will
help to improve the accuracy of the
adjustment. In addition, the expansion
will anticipate further changes in the
workforce brought by changes in labor
market, including the increased demand
for expertise in the adoption and use of
health information technology’’ (pp. 5–
34). As such, we are modifying our
proposal and including all (100%) of
non-physician occupations in the offices
of physicians industry in our employee
compensation PE calculation. Our
modification to include the full range of
non-physician occupations in response
to these comments will increase the
number of occupations captured in our
employee wage calculation from 33 to
155.
We disagree with commenters who
provide radiation oncology services and
suggested that we should include
medical physicists wage data from the
American Association of Physicists in
Medicine or the American Academy of
Pain Medicine. The use of a consistent
and contemporaneous source for the
employment and wage data included in
the calculation is preferable to a mix of
supplemental data sources. Also, while
BLS does not collect employment and
wage data for medical physicists or
health physicists specifically, it does
collect employment and wage data for
physicists as a whole (SOC code 19–
2012 specifically includes physicists,
see https://www.bls.gov/opub/ooq/2011/
summer/art02.pdf, pg. 20). These data
will be included in our calculation now
that we are incorporating the full range
of occupations employed in physician
offices.
With respect to the commenters who
indicated the occupational weights
utilized by CMS are not representative
of their actual practices or the MGMA
data, we understand that national
occupational weights may not match
individual practices or subsets of
practices. However, we agree with
IOM’s preference for ‘‘a consistent set of
national weights applied to wage data
from the full range of health sector
occupations so that hourly wage
comparisons can be made’’ (pp. 5–34).
Office Rent
Comment: Some commenters agreed
with our proposal to use the ACS data
instead of the HUD FMR data.
Additionally, some commenters stated
that the 3-year ACS was preferable to
the 5-year ACS rental data, because it is
more recent and thus more likely to
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reflect current value differences in the
rapidly changing marketplace. However,
most commenters reiterated their
longstanding opposition to the use of
residential rent as a proxy for physician
office space and indicated that a better
solution would be for the government to
develop actual data on the cost of
renting medical office space consistent
with the IOM recommendation. Some
commenters recommended a survey of
physicians to acquire data on medical
office rent. Others recommended a
continued use of HUD data for CY 2012
until the ACS is more robust. Several
commenters recommended that CMS
use data from the MGMA survey to
develop a medical office rent index.
Commenters also raised issues with the
relative relationship between selected
individual counties in the ACS data or
between the ACS data and CMS’
assigned weights, questioning the
validity of the methodology. These
comments noted that the rent index in
Santa Clara increased 7 percent yet
remained unchanged in surrounding
counties; the rent index in Ft.
Lauderdale, Florida, and Teton County,
Wyoming, are higher than rent index for
Manhattan, New York; and Polk County,
Iowa, and San Francisco County,
California, have inconsistencies
between the ACS-reported median and
CMS’ assigned weights.
Response: We appreciate all the
comments received on our proposal to
utilize the 3-year (2006–2008) ACS 2
bedroom rental data as our proxy for
physician office rent. We agree with the
commenters who stated that the ACS
data is preferable to the current HUD
FMR data. We also agree with
commenters that a commercial data
source for office rent that provided for
adequate data representation of urban
and rural areas would be preferable to
a residential rent proxy. As we have
previously discussed in the CY 2005,
CY 2008, and CY 2011 (69 FR 66262, 72
FR 73257, and 75 FR 73257
respectively) final rules, we recognize
that apartment rents may not be a
perfect proxy for physician office rent.
We have conducted an exhaustive
search for a reliable commercial rental
data source and have not found any
reliable data that meets our accuracy
standards. We describe in detail our
search for a current, reliable, and
publicly available commercial rent data
source in our ‘‘Final Report on the Sixth
Update of the Geographic Practice Cost
Index for the Medicare Physician Fee
Schedule’’ viewable at https://
www.cms.gov/PhysicianFeeSched/
downloads/GPCI_Report.pdf. In
addition, the IOM in their report titled
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‘‘Geographic Adjustment in Medicare
Payment Phase 1: Improving Accuracy’’
(pp 5–35) was unable to identify a
source for commercial rent data.
With regards to surveying physicians
directly to gather data to compute office
rent, we note that development and
implementation of a survey could take
several years. Moreover, we have
historically not sought direct survey
data from physicians related to the GPCI
to avoid issues of circularity and selfreporting bias. Also, in the CY 2011
final rule with comment period (75 FR
73259) we asked for specific public
comments regarding the benefits of
utilizing physician cost reports to
potentially achieve greater precision in
measuring the relative cost difference
among Medicare localities. We also
asked for comments related to the
administrative burden of requiring
physicians to routinely complete these
cost reports and whether this should be
mandatory for physicians practices. We
did not receive any feedback
specifically related to this comment
solicitation during the open public
comment period for the CY 2011 final
rule with comment period.
With regard to comments requesting
that CMS use data from the MGMA
survey to develop the office rent index,
as we stated in the CY 2011 final rule
with comment period (75 FR 73257), we
have concerns with both the sample size
and representativeness of the MGMA
data. For example, the responses
represent only about 2,250 (or
approximately 1 percent of physician
practices nationwide) and have
disproportionate sample sizes for each
State, suggesting very uneven response
rates geographically. In addition, we
also have concerns that the MGMA data
have the potential for response bias. The
MGMA’s substantial reliance on its
membership base suggests a nonrandom
selection into the respondent group.
Some evidence for such issues in the
MGMA data arises from the very
different sample sizes by State. For
example, in the MGMA data, 10 States
have fewer than 10 observations each,
and California, New York, and New
Jersey have fewer than 10 observations
per locality. Therefore, we continue to
believe the MGMA survey data would
not be a sufficient rental data source for
all PFS localities.
With regards to comments that rents
in Santa Clara increased 7 percent yet
remained unchanged in the surrounding
counties (San Francisco, San Mateo and
Santa Cruz), we contacted the Census
Bureau and verified that the data were
correct. We also checked with the
Census Bureau regarding commenter
observations that the rent index value
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for two bedroom rental units is higher
in Ft. Lauderdale, Florida, and Teton
County, Wyoming, than in Manhattan.
Census verified that these data were
correct.
With regards to comments on rents in
Polk County, Iowa, compared to San
Francisco County, California, Polk
County has the second highest office
rent index of any county in Iowa (at
0.848). In order to accurately compare
the specific relationship between these
two counties office rent indices, the
Polk County specific office rent index of
(.848) should be applied. However, the
commenters applied the Iowa
‘‘Statewide’’ locality level index of
(.696) to Polk County in their
calculations. Because Iowa is a
Statewide locality, the higher office rent
index for Polk County is reduced when
combined with lower cost counties in
our GPCI methodology.
As we have stated previously, we did
not receive a special tabulation from
Census in time to analyze 5-year ACS
rental data as a potential data source for
physician office rent for the CY 2012
rulemaking cycle. We have now
received the 5-year ACS special
tabulation from Census and will
examine its suitability as a potential
proxy for physician office rent. We will
also continue our evaluation of ACS
rental data during the upcoming year,
and may propose further modifications
to our office rent methodology in the CY
2013 PFS proposed rule.
We also note that HUD has proposed
a new FMR methodology for 2012 that
abandons the use of Census long-form
data, which are no longer being
collected, and instead relies exclusively
on ACS data. We will be examining this
new proposed methodology to
potentially inform future rulemaking.
Purchased Services
Comment: Commenters generally
agreed with our proposal to create a
purchased service index to capture
labor-related categories that reside
within the ‘‘All Other Services’’ and
‘‘Other Professional Expenses’’ MEI
categories. In addition, several
commenters noted that the purchased
services index accurately reflects
variable professional and nonprofessional labor costs. However, some
commenters disagreed with the proposal
to create a purchased service index. The
reasons cited included that there is no
statutory requirement to add the
purchased services proxy to the PE
GPCI; the proposed methodology does
not adequately capture geographic
variation in purchased services; (for
example there is no basis to support the
assertion that the cost of capital is equal
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across the country) and, the purchased
service index must be reflective of
actual physician practice cost expenses
and should be based on physician
survey data. Lastly, some commenters
recommend that CMS consult with
physicians’ organizations and others to
test its categorizations, methodologies,
and assumptions.
Response: We agree with commenters
who stated that the purchased services
index adds an additional level of
precision to our PE GPCI calculations.
Even though physician practices often
purchase accounting, legal, advertising,
consulting, landscaping, and other
services from a variety of outside
contractors, we have not previously
included regional variation in the cost
of purchased services within the current
employee wage index. Specifically, the
current methodology only measures
regional variation in wages for workers
that physician practices employ
directly. For these reasons, we worked
with our contractor to develop our
proposed ‘‘purchased services index’’ to
account for the regional labor cost
variation within contracted services.
This index captures labor-related
categories residing within the ‘‘all other
services’’ and ‘‘other professional
expenses’’ MEI categories, and
addresses the concerns of commenters,
who in the CY 2011 final rule with
comment period (75 FR 73258), thought
that these services needed to be
geographically adjusted.
We disagree with commenters who
think there is insufficient statutory basis
for a purchased services index. The
incorporation of a purchased services
index improves the accuracy of the
GPCI consistent with the statute. It will
allow for the GPCI to account for
geographic variation in the price of a
wider range of inputs.
We also disagree with commenters
who asserted that the proposed
methodology does not adequately
capture geographic variation in
purchased services, including the cost
of capital, and asserted that our data
sources were inadequate. To adjust for
regional variation in the labor inputs of
purchased services requires four key
elements. These elements include: Wage
data by occupation, industry
employment levels, labor-related
classifications by industry, and the
share of physician practice expense. We
are using a combination of BLS OES
data and MEI weight data for these
elements. The BLS OES data is the best
currently available data source for this
purpose and is used in many aspects of
the GPCI calculation. The MEI weights
represent our actuaries’ best estimate for
the weights for these categories. For a
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fuller discussion of the derivation of the
MEI weights, see the CY 2011 final rule
with comment period (75 FR 73262).
With respect to capital, it is important
to note that the proposed purchased
services index does not assume that the
cost of capital for physician practices is
constant across the nation; instead, it
assumes that the cost of capital for
contracted firms is constant across the
nation. Within the purchased services
index, we assume a constant cost of
capital for the purchased service firm
primarily because we do not believe a
reliable data source to measure capital
costs for each purchased service
industry currently exists.
With respect to commenters who
recommended that we consult with
physician organizations and others to
test our categorizations, methodologies,
and assumptions, we have been and will
continue to be transparent with respect
to our calculation of the purchased
services index. We solicited comments
on our proposed approach and have
given consideration to all comments
received.
Updated Cost Share Weights
Comment: Commenters expressed
both support and concern with our
proposal to update the cost share
weights to reflect the 2006-based MEI
weights finalized in the CY 2011 final
rule with comment period. Several
commenters noted that it was
appropriate for CMS to update the cost
share weights based on the more recent
AMA physician survey data reflected in
the current MEI weights, but not
currently reflected in the GPCI cost
share weights. Other commenters stated
that the cost share weights should not
be adjusted until CMS convenes the MEI
technical advisory panel. A few
commenters indicated that CMS should
not update the cost share weights but
should instead explore the use of
alternative data sources, such as MGMA
or physician surveys, for the weights.
Response: We agree with commenters
who supported updating the GPCI cost
share weights based on the MEI weights,
which reflect the most recent AMA
survey data. We have historically
updated the GPCI cost share weights
consistent with previous adjustments to
the MEI. Due partly to concerns
commenters raised during last year’s
rulemaking (see 75 FR 73256) on
specific aspects of the GPCI
methodology, we delayed updating the
GPCI cost weights to reflect the updated
MEI weights. Our CY 2012 changes to
the GPCI methodology have addressed
these comments where appropriate.
We disagree with commenters who
indicated that the cost share weights
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should not be adjusted until CMS
convenes the MEI technical advisory
panel. The current MEI cost share
weights are based on the most recent
AMA survey data. The current GPCI
cost share weights are based on the old
MEI weights reflecting older AMA
survey data. It would not be appropriate
to continue to delay the adoption of the
current MEI weights reflective of more
recent AMA survey data in favor of
continuing to use the old MEI weights
reflective of older AMA survey data. For
additional discussion of the derivation
of the MEI weights, please see (75 FR
73262). We will study the findings and
recommendations of the MEI technical
advisory panel once the panel has had
an opportunity to meet and issue its
findings. For similar reasons, we also
disagree with commenters who
indicated that CMS should not update
the cost share weights but should
instead explore the use of alternative
data sources, such as MGMA or
physician surveys, for the weights. In
addition, as discussed earlier, we have
concerns with both the sample size and
representativeness of the MGMA data.
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Impacts
Comment: Many commenters
requested that CMS should provide an
impact table that separately shows the
impact of each of our proposals.
Response: We will provide separate
impact tables in our ‘‘Revisions to the
Sixth Update of the Geographic Practice
Cost Index: Final Report’’ that will
individually show the GAF impacts of:
Revising the GPCI cost share weights to
be consistent with the revised and
rebased 2006-based MEI; expanding the
occupations used in the calculation of
non-physician employee wage to reflect
the full range of occupations in the
offices of physicians’ industry;
implementing a purchased service index
to account for labor-related services in
the ‘‘all other services’’ and ‘‘other
professional services’’ MEI categories;
and utilizing the 2006–2008 ACS for
two bedroom units as the proxy for
physician office rent. This final report is
viewable at the following Web address:
https://www.cms.gov/
PhysicianFeeSched/.
Delay Implementation of GPCI
Revisions Until IOM Studies Are
Completed
Comment: Many commenters urged
us not to move forward with proposed
changes to the PE GPCI until CMS and
various stakeholders have had an
opportunity to assess the full impacts
and recommendations of the IOM
reports on Medicare geographic
adjustments.
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Response: As previously mentioned,
section 1848(e)(1)(H)(iv) of the Act (as
added by section 3102(b) of the
Affordable Care Act) requires the
Secretary to ‘‘analyze current methods
of establishing practice expense
adjustments under subparagraph (A)(i)
and evaluate data that fairly and reliably
establishes distinctions in the cost of
operating a medical practice in the
different fee schedule areas.’’
Moreover, section 1848(e)(1)(H)(v) of
the Act requires the Secretary to make
appropriate adjustments to the PE GPCIs
as a result of the required analysis no
later than January 1, 2012. As a result
of our analysis, we proposed the four
changes to the PE GPCI calculation as
discussed previously in this section.
While we fully intend to continue our
review of the recently released revised
IOM Phase I report on the Medicare
GPCIs, it is important and consistent
with the statute to proceed with
appropriate improvements to the GPCI
methodology in conjunction with our
review of IOM’s reports and IOM’s
continuing work in this area. We may
propose further improvements and
modifications to the GPCIs methodology
in future rulemaking once we have had
an opportunity to assess IOM’s
recommendations in their entirety.
Budget Neutrality
Comment: Some commenters stated
that the modifications proposed in the
revised Sixth GPCI Update were not
budget neutral. These commenters
provided tables illustrating the impacts
on the single view chest x-ray service.
Response: We disagree that the
modifications in the revised Sixth GPCI
were not budget neutral. Our actuaries
have determined that the CY 2012
GPCIs are budget neutral in the
aggregate prior to the application of any
statutory GPCI provisions (section
1848(e)(1)(G) and section 1848(e)(1)(I) of
the Act) that are exempt by law from
budget neutrality. The GPCIs are not
necessarily budget neutral on an
individual service by service basis.
Other Issues
We received other public comments
on matters that were not related to our
proposed CY 2012 changes to the GPCIs.
We thank the commenters for sharing
their views and suggestions. Because we
did not make proposals regarding these
matters, we do not generally summarize
or respond to such comments in this
final rule with comment period. For
example, we received numerous
comments related to the physician work
GPCI and the aforementioned expiration
of the 1.000 work floor. Since we only
proposed to update the cost share
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weights attributed to physician work,
and noted that the statutorily required
1.0 physician work floor would be
expiring at the end of CY 2011 in the CY
2012 proposed rule, we will not be
responding to comments related to our
methodologies or calculations of
physician work in this final rule with
comment period. For an in-depth
discussion of our most recent physician
work GPCI update, see the CY 2011 final
rule with comment period (75 FR 73252
and 75 FR 73256 through 73260). We
look forward to reviewing and
evaluating the IOM’s recommendations
related to physician work included in
its revised Phase I report. After we have
reviewed the IOM’s recommendations
in their entirety, we may propose
modifications to the physician work
GPCI in future rulemaking.
We also received several comments
regarding the calculations and
methodology used to calculate the MEI,
although we did not propose any
changes in the methodology used to
calculate the MEI. Many commenters
reiterated concerns regarding the
assignment of MEI weights to the 10
office expense subcategories as outlined
in the 2011 Medicare physician
payment schedule final rule with
comment period. According to some
commenters, it is not clear that the
AMA PPIS survey expense categories
match up with the industry-level data
from the Bureau of Economic Analysis
in a way that makes this assignment of
subcategory weights possible. These
commenters further state that the MEI
technical advisory panel should revisit
this issue, and consider whether other
sources of data are available to split
office rent from other types of office
expenses, and to validate the office rent
share as a percent of total expense.
While this issue is outside the scope
of this final rule with comment, we note
that the costs reported in the 2006 AMA
PPIS survey questions for office
expenses were crosswalked as closely as
possible to the 2002 BEA I/O benchmark
categories. The weights for Office
Expenses found in the MEI were
appropriately based on information
reported by self-employed physicians
and selected self-employed non-medical
doctor specialties found in the 2006
American Medical Association
Physician Practice Information Survey
(PPIS). The PPIS was developed by
medical associations and captures the
costs of operating a medical practice,
including office rents and nonphysician wages. The survey results
were further disaggregated using data
from the Bureau of Economic Analysis’
Benchmark Input/Output tables for
Offices of Physicians, Dentists, and
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Other Health Professionals. These
resulting cost shares, along with the
methods that were utilized in
developing them, were proposed (75 FR
40087 through 40092) and finalized (75
FR 73262 through 73276) during the
calendar year 2011, Physician Fee
Schedule rule, rulemaking process. As
stated in the CY 2011 final rule, (75 FR
73270 through 73276), the MEI
technical advisory panel, will be asked
to fully evaluate the index. In particular,
the panel will be evaluating all
technical aspects of the MEI including
the cost categories, their associated
weights and price proxies, and the
productivity adjustment.
e. Summary of CY 2012 Final GPCIs
After consideration of the public
comments received on the GPCIs, we are
finalizing the revisions to the 6th GPCI
update using the most current data, with
modifications. We are also finalizing the
proposal to change the GPCI cost share
weights for CY 2012. As a result, the
cost share weight for the physician work
GPCI (as a percentage of the total) will
be 48.266 percent, and the cost share
weight for the PE GPCI will be 47.439
percent with a change in the employee
compensation component from 18.654
to 19.153 percentage points. The cost
share weight for the office rent
component of the PE GPCI will be
10.223 percentage points (fixed capital
with utilities), and the medical
equipment, supplies, and other
miscellaneous expenses component will
be 9.968 percentage points. Moreover,
the cost share weight for the malpractice
GPCI will be 4.295 percent. In addition,
we are finalizing the weight for
purchased services at 8.095 percentage
points (5.011 percentage points will be
adjusted for geographic cost
differences). Additionally, we will
review the complete findings and
recommendations from the Institute of
Medicine’s studies on geographic
adjustment factors for physician
payment and the MEI technical advisory
panel once that information becomes
fully available to CMS. We will once
again consider the GPCIs for CY 2013
rulemaking in the context of our annual
PFS rulemaking beginning in CY 2012
based on the information available at
that time. We are finalizing the use of
2006 through 2008 ACS two bedroom
rental data as a proxy for the relative
cost difference in physicians’ offices.
Moreover, we will examine 5-year ACS
rental data to determine its
appropriateness as a potential data
source for physician office rent. We will
also examine HUDs CY 2012 proposed
methodology, which utilizes ACS data
exclusively, for potential use in future
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rulemaking. We are also finalizing our
proposal to create a purchased services
index to account for labor-related
services with the ‘‘all other services’’
and ‘‘other professional expenses’’ MEI
components. In response to public
commenters who recommended we
utilize BLS data to capture the ‘‘full
range’’ of occupations included in the
offices of physician industry to calculate
employee wage, we are modifying our
original proposal and expanding the
number of occupations utilized in our
calculation of non-physician employee
wages to reflect 100 percent of the total
wage share of non-physician
occupations in the offices of physicians’
industry.
As we indicated previously in this
section, section 103 of the Medicare and
Medicaid Extenders Act (MMEA) of
2010 (Pub. L. 111–309) extended the 1.0
work GPCI floor only through December
31, 2011. Therefore, the CY 2012
physician work GPCIs and summarized
GAFs do not reflect the 1.0 work floor.
Moreover, the limited recognition of
cost differences in employee
compensation and office rent for the PE
GPCIs, and the related hold harmless
provision, required under section 1848
(e)(1)(H) of the Act was only applicable
for CY 2010 and CY 2011 (75 FR 73253)
and, therefore under current law, is no
longer effective beginning in CY 2012.
However, the permanent 1.5 work GPCI
floor for Alaska (as established by
section 134(b) of the MIPPA) will
remain in effect for CY 2012. We are
finalizing the CY 2012 GPCIs shown in
Addendum E. The GPCIs have been
budget neutralized to ensure that
nationwide, total RVUs are not
impacted by changes in locality GPCIs.
The 1.0 PE GPCI floor for frontier States
was applied to the budget neutralized
GPCIs. The frontier States are the
following: Montana; Wyoming; North
Dakota; Nevada; and South Dakota. The
CY 2012 updated GAFs and GPCIs may
be found in Addenda D and E of this
final rule with comment period.
3. Payment Localities
The current PFS locality structure was
developed and implemented in 1997.
There are currently 89 total PFS
localities; 34 localities are Statewide
areas (that is, only one locality for the
entire State). There are 52 localities in
the other 16 States, with 10 States
having 2 localities, 2 States having 3
localities, 1 State having 4 localities,
and 3 States having 5 or more localities.
The District of Columbia, Maryland,
Virginia suburbs, Puerto Rico, and the
Virgin Islands are additional localities
that make up the remaining 3 of the
total of 89 localities. The development
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of the current locality structure is
described in detail in the CY 1997 PFS
proposed rule (61 FR 34615) and the
subsequent final rule with comment
period (61 FR 59494).
As we have previously noted in the
CYs 2008 and 2009 proposed rules (72
FR 38139 and 73 FR 38513), any
changes to the locality configuration
must be made in a budget neutral
manner within a State and can lead to
significant redistributions in payments.
For many years, we have not considered
making changes to localities without the
support of a State medical association in
order to demonstrate consensus for the
change among the professionals whose
payments would be affected (since such
changes would be redistributive, with
some increasing and some decreasing).
However, we have recognized that, over
time, changes in demographics or local
economic conditions may lead us to
conduct a more comprehensive
examination of existing payment
localities.
For the past several years, we have
been involved in discussions with
physician groups and their
representatives about recent shifts in
relative demographics and economic
conditions. We explained in the CY
2008 PFS final rule with comment
period that we intended to conduct a
thorough analysis of potential
approaches to reconfiguring localities
and would address this issue again in
future rulemaking. For more
information, we refer readers to the CY
2008 PFS proposed rule (72 FR 38139)
and subsequent final rule with comment
period (72 FR 66245).
As a follow-up to the CY 2008 PFS
final rule with comment period, we
acquired a contractor to conduct a
preliminary study of several options for
revising the payment localities on a
nationwide basis. The final report
entitled, ‘‘Review of Alternative GPCI
Payment Locality Structures—Final
Report,’’ is accessible from the CMS PFS
Web page https://www.cms.hhs.gov/
PhysicianFeeSched/10_Interim_Study.
asp#TopOfPage under the heading
‘‘Review of Alternative GPCI Payment
Locality Structures—Final Report.’’ The
report may also be accessed directly
from the following link: https://
www.cms.gov/PhysicianFeeSched/
downloads/Alt_GPCI_Payment_
Locality_Structures_Review.pdf.
We did not make any proposals
regarding the PFS locality
configurations for CY 2012. However,
we did receive some comments
regarding IOM’s recommendation to
modify Medicare PFS localities to
reflect metropolitan statistical areas
(MSA)-based definitions. We will
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address any changes to Medicare PFS
localities in future rulemaking.
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4. Report From the Institute of Medicine
At our request, the Institute of
Medicine is conducting a study of the
geographic adjustment factors in
Medicare payment. It is a
comprehensive empirical study of the
geographic adjustment factors
established under sections 1848(e)
(GPCI) and 1886(d)(3)(E) of the Act
(hospital wage index). These
adjustments are designed to ensure
Medicare payment fees and rates reflect
differences in input costs across
geographic areas. The factors IOM is
evaluating include the—
• Accuracy of the adjustment factors;
• Methodology used to determine the
adjustment factors, and
• Sources of data and the degree to
which such data are representative.
Within the context of the U.S. health
care marketplace, the IOM is also
evaluating and considering the—
• Effect of the adjustment factors on
the level and distribution of the health
care workforce and resources,
including—
++ Recruitment and retention taking
into account mobility between urban
and rural areas;
++ Ability of hospitals and other
facilities to maintain an adequate and
skilled workforce; and
++ Patient access to providers and
needed medical technologies;
• Effect of adjustment factors on
population health and quality of care;
and
• Effect of the adjustment factors on
the ability of providers to furnish
efficient, high value care.
The revised first report ‘‘Geographic
Adjustment in Medicare Payment, Phase
I: Improving Accuracy’’ that was
released September 28, 2011 and is
available on the IOM Web site https://
www.iom.edu/Reports/2011/
Geographic-Adjustment-in-MedicarePayment-Phase-I-ImprovingAccuracy.aspx. It evaluates the accuracy
of geographic adjustment factors and the
methodology and data used to calculate
them, and contains supplemental GPCI
recommendations that were not
contained in IOM’s initial June 1st
report. In its final report, scheduled to
be released in the spring of 2012, the
IOM will consider the role effect of
Medicare payments in on matters such
as the distribution of the health care
workforce, population health, and the
ability of providers to produce highvalue, high-quality health care.
The recommendations included in
IOM’s revised Phase I report that relate
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to or would have an effect on the GPCIs
are summarized as follows:
• Recommendation 2–1: The same
labor market definition should be used
for both the hospital wage index and the
physician geographic adjustment factor.
Metropolitan statistical areas and
Statewide non-metropolitan statistical
areas should serve as the basis for
defining these labor markets.
• Recommendation 2–2: The data
used to construct the hospital wage
index and the physician geographic
adjustment factor should come from all
health care employers.
• Recommendation 5–1: The GPCI
cost share weights for adjusting fee-forservice payments to practitioners should
continue to be national, including the
three GPCIs (work, practice expense,
and liability insurance) and the
categories within the practice expense
(office rent and personnel).
• Recommendation 5–2: Proxies
should continue to be used to measure
geographic variation in the physician
work adjustment, but CMS should
determine whether the seven proxies
currently in use should be modified.
• Recommendation 5–3: CMS should
consider an alternative method for
setting the percentage of the work
adjustment based on a systematic
empirical process.
• Recommendation 5–4: The practice
expense GPCI should be constructed
with the full range of occupations
employed in physicians’ offices, each
with a fixed national weight based on
the hours of each occupation employed
in physicians’ offices nationwide.
• Recommendation 5–5: CMS and the
Bureau of Labor Statistics should
develop an agreement allowing the
Bureau of Labor Statistics to analyze
confidential data for the Centers for
Medicare and Medicaid Services.
• Recommendation 5–6: A new
source of information should be
developed to determine the variation in
the price of commercial office rent per
square foot.
• Recommendation 5–7: Nonclinical
labor-related expenses currently
included under practice expense office
expenses should be geographically
adjusted as part of the wage component
of the practice expense.
We note that the GPCI revisions we
are finalizing in this final rule with
comment period address three of the
IOM recommendations referenced
above. Specifically, our final GPCIs
utilize the full range of non-physician
occupations in the non-physician
employee wage calculation consistent
with IOM recommendation 5–4.
Additionally, we created a new
purchased service index to account for
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non-clinical labor-related expenses
similar to IOM recommendation 5–7.
Lastly, we have consistently used
national cost share weights (MEI) to
determine the appropriate weight
attributed to each GPCI component,
which is supported by recommendation
5–1. We may propose further
improvements to the GPCI methodology
in future rulemaking to address the
remaining IOM recommendations once
we have had an opportunity to assess
IOM’s recommendations in their
entirety.
E. Medicare Telehealth Services for the
Physician Fee Schedule
1. Billing and Payment for Telehealth
Services
a. History
Prior to January 1, 1999, Medicare
coverage for services delivered via a
telecommunications system was limited
to services that did not require a faceto-face encounter under the traditional
model of medical care. Examples of
these services included interpretation of
an x-ray, or electrocardiogram, or
electroencephalogram tracing, and
cardiac pacemaker analysis.
Section 4206 of the BBA provided for
coverage of, and payment for,
consultation services delivered via a
telecommunications system to Medicare
beneficiaries residing in rural health
professional shortage areas (HPSAs) as
defined by the Public Health Service
Act. Additionally, the BBA required that
a Medicare practitioner (telepresenter)
be with the patient at the time of a
teleconsultation. Further, the BBA
specified that payment for a
teleconsultation had to be shared
between the consulting practitioner and
the referring practitioner and could not
exceed the fee schedule payment which
would have been made to the consultant
for the service provided. The BBA
prohibited payment for any telephone
line charges or facility fees associated
with the teleconsultation. We
implemented this provision in the CY
1999 PFS final rule with comment
period (63 FR 58814).
Effective October 1, 2001, section 223
of the Medicare, Medicaid and SCHIP
Benefits Improvement Protection Act of
2000 (Pub. L. 106–554) (BIPA) added a
new section, 1834(m), to the Act which
significantly expanded Medicare
telehealth services. 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
delivered via a telecommunications
system. We first implemented this
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provision in the CY 2002 PFS final rule
with comment period (66 FR 55246).
Section 1834(m)(4)(F)(ii) of the Act
required the Secretary to establish a
process that provides for annual updates
to the list of Medicare telehealth
services. We established this process in
the CY 2003 PFS final rule with
comment period (67 FR 79988).
As specified in regulations at
§ 410.78(b), we generally require that a
telehealth service be furnished via an
interactive telecommunications system.
Under § 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
the practitioner at the distant site.
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 does allow the use of
asynchronous ‘‘store-and-forward’’
technology in delivering these services
when the originating site is a Federal
telemedicine demonstration program in
Alaska or Hawaii. As specified in
regulations at § 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
provided to an eligible telehealth
individual notwithstanding the fact that
the individual practitioner providing
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. As specified in BIPA,
originating sites are limited under
section 1834(m)(3)(C) of the Act to
specified medical facilities located in
specific geographic areas. The initial list
of telehealth originating sites included
the office of a practitioner, a critical
access hospital (CAH), a rural health
clinic (RHC), a Federally qualified
health center (FQHC) and a hospital (as
defined in Section 1861(e) of the Act).
More recently, section 149 of the
Medicare Improvements for Patients and
Providers Act of 2008 (Pub. L. 110–275)
(MIPPA) expanded the list of telehealth
originating sites to include hospitalbased renal dialysis centers, skilled
nursing facilities (SNFs), and
community mental health centers
(CMHCs). In order to serve as a
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telehealth originating site, these sites
must be located in an area designated as
a rural health professional shortage area
(HPSA), in a county that is not in a
metropolitan statistical area (MSA), or
must be an entity that participates in a
Federal telemedicine demonstration
project that has been approved by (or
receives funding from) the Secretary of
Health and Human Services as of
December 31, 2000. Finally, section
1834(m) of the Act does not require the
eligible telehealth individual to be
presented by a practitioner at the
originating site.
b. Current Telehealth Billing and
Payment Policies
As noted previously, Medicare
telehealth services can only be
furnished to an eligible telehealth
beneficiary in an originating site. An
originating site is 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. In
general, originating sites must be
located in a rural HPSA or in a county
outside of an MSA. The originating sites
authorized by the statute are as follows:
• Offices of a physician or
practitioner.
• Hospitals.
• CAHs.
• RHCs.
• FQHCs.
• Hospital-Based Or Critical Access
Hospital-Based Renal Dialysis Centers
(including Satellites).
• SNFs.
• CMHCs.
Currently approved Medicare
telehealth services include the
following:
• Initial inpatient consultations.
• Follow-up inpatient consultations.
• Office or other outpatient visits.
• Individual psychotherapy.
• Pharmacologic management.
• Psychiatric diagnostic interview
examination.
• End-stage renal disease (ESRD)
related services.
• Individual and group medical
nutrition therapy (MNT).
• Neurobehavioral status exam.
• Individual and group health and
behavior assessment and intervention
(HBAI).
• Subsequent hospital care.
• Subsequent nursing facility care.
• Individual and group kidney
disease education (KDE).
• Individual and group diabetes selfmanagement training services (DSMT).
In general, the practitioner at the
distant site may be any of the following,
provided that the practitioner is
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licensed under State law to furnish the
service being furnished via a
telecommunications system:
• Physician.
• Physician assistant (PA).
• Nurse practitioner (NP).
• Clinical nurse specialist (CNS);
• Nurse-midwife.
• Clinical psychologist.
• Clinical social worker.
• Registered dietitian or nutrition
professional.
Practitioners furnishing Medicare
telehealth services are located at a
distant site, and they 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.
Distant site practitioners must submit
the appropriate HCPCS procedure code
for a covered professional telehealth
service, appended with the -GT (Via
interactive audio and video
telecommunications system) or -GQ (Via
asynchronous telecommunications
system) modifier. By reporting the -GT
or -GQ modifier with a covered
telehealth procedure code, the distant
site practitioner certifies that the
beneficiary was present at a telehealth
originating site when the telehealth
service was furnished. The usual
Medicare deductible and coinsurance
policies apply to the telehealth services
reported by distant site practitioners.
Section 1834(m)(2)(B) of the Act
provides for payment of a facility fee to
the originating site. To be paid the
originating site facility fee, the provider
or supplier where the eligible telehealth
individual is located must submit a
claim with HCPCS code Q3014
(Telehealth originating site facility fee),
and the provider or supplier is paid
according to the applicable payment
methodology for that facility or location.
The usual Medicare deductible and
coinsurance policies apply to HCPCS
code Q3014. By submitting HCPCS code
Q3014, the originating site certifies that
it is located in either a rural HPSA or
non-MSA county or is an entity that
participates in a Federal telemedicine
demonstration project that has been
approved by (or receives funding from)
the Secretary of Health and Human
Services as of December 31, 2000 as
specified in section 1834(m)(4)(C)(i)(III)
of the Act.
As previously described, certain
professional services that are commonly
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furnished remotely using
telecommunications technology, but
that do not require the patient to be
present in-person with the practitioner
when they are furnished, are covered
and paid in the same way as services
delivered without the use of
telecommunications technology when
the practitioner is in-person at the
medical facility furnishing care to the
patient. Such services typically involve
circumstances where a practitioner is
able to visualize some aspect of the
patient’s condition without the patient
being present and without the
interposition of a third person’s
judgment. Visualization by the
practitioner can be possible by means of
x-rays, electrocardiogram or
electroencephalogram tracings, tissue
samples, etc. For example, the
interpretation by a physician of an
actual electrocardiogram or
electroencephalogram tracing that has
been transmitted via telephone (that is,
electronically, rather than by means of
a verbal description) is a covered
physician’s service. These remote
services are not Medicare telehealth
services as defined under section
1834(m) of the Act. Rather, these remote
services that utilize telecommunications
technology 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 (that is,
without the -GT or -GQ modifier
appended).
2. Requests for 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 request to make additions to
the list of Medicare telehealth services
to one of the following categories:
• 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. We
also look for similarities in the
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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
use of a telecommunications system to
deliver the service produces similar
diagnostic findings or therapeutic
interventions as compared with the inperson delivery of the same service.
Requestors should submit evidence
showing that the use of a
telecommunications system does not
affect the diagnosis or treatment plan as
compared to in-person delivery of the
requested service.
Since establishing the process to add
or remove services from the list of
approved telehealth services, we have
added the following to the list of
Medicare telehealth services: individual
and group HBAI services; psychiatric
diagnostic interview examination; ESRD
services with 2 to 3 visits per month and
4 or more visits per month (although we
require at least 1 visit a month to be
furnished in-person by a physician,
CNS, NP, or PA in order to examine the
vascular access site); individual and
group MNT; neurobehavioral status
exam; initial and follow-up inpatient
telehealth consultations for beneficiaries
in hospitals and skilled nursing
facilities (SNFs); subsequent hospital
care (with the limitation of one
telehealth visit every 3 days);
subsequent nursing facility care (with
the limitation of one telehealth visit
every 30 days); individual and group
KDE; and individual and group DSMT
services (with a minimum of 1 hour of
in-person instruction to ensure effective
injection training).
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, requests submitted
before the end of CY 2011 will be
considered for the CY 2013 proposed
rule. Each request for adding 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,
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we refer readers to the CMS Web site at
https://www.cms.gov/telehealth/.
3. Submitted Requests for Addition to
the List of Telehealth Services for CY
2012
We received requests in CY 2010 to
add the following services as Medicare
telehealth services effective for CY 2012:
(1) Smoking cessation services; (2)
critical care services; (3) domiciliary or
rest home evaluation and management
services; (4) genetic counseling services;
(5) online evaluation and management
services; (6) data collection services;
and (7) audiology services. The
following presents a discussion of these
requests, including our proposals for
additions to the CY 2012 telehealth list.
a. Smoking Cessation Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add smoking
cessation services, reported by CPT
codes 99406 (Smoking and tobacco use
cessation counseling visit; intermediate,
greater than 3 minutes up to 10 minutes)
and 99407 (Smoking and tobacco use
cessation counseling visit; intensive,
greater than 10 minutes) to the list of
approved telehealth services for CY
2012 on a category 1 basis.
Smoking Cessation services are
defined as face-to-face behavior change
interventions. We believe the
interaction between a practitioner and a
beneficiary receiving smoking cessation
services is similar to the education,
assessment, and counseling elements of
individual KDE reported by HCPCS
code G0420 (Face-to-face educational
services related to the care of chronic
kidney disease; individual, per session,
per 1 hour), and individual MNT
services, reported by HCPCS code
G0270 (Medical nutrition therapy;
reassessment and subsequent
intervention(s) following second referral
in the same year for change in diagnosis,
medical condition or treatment regimen
(including additional hours needed for
renal disease), individual, face-to-face
with the patient, each 15 minutes); CPT
code 97802 (Medical nutrition therapy;
initial assessment and intervention,
individual, face-to-face with the patient,
each 15 minutes); and CPT code 97803
(Medical nutrition therapy; reassessment and intervention,
individual, face-to-face with the patient,
each 15 minutes), all services that are
currently on the telehealth list.
Therefore, we proposed to add CPT
codes 99406 and 99407 to the list of
telehealth services for CY 2012 on a
category 1 basis. Additionally, we
proposed to add HCPCS codes G0436
(Smoking and tobacco cessation
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counseling visit for the asymptomatic
patient; intermediate, greater than 3
minutes, up to 10 minutes) and G0437
(Smoking and tobacco cessation
counseling visit for the asymptomatic
patient; intensive, greater than 10
minutes) to the list of telehealth services
for CY 2012 since these related services
are similar to the codes for which we
received formal public requests.
Consistent with this proposal, we also
proposed to revise our regulations at
§ 410.78(b) and § 414.65(a)(1) to include
these smoking cessation services as
Medicare telehealth services.
Comment: All commenters expressed
support for CMS’ proposal to add
smoking cessation services to the list of
Medicare telehealth services for CY
2012. One commenter stated that the
proposal would contribute to ensuring
that all Medicare beneficiaries—
regardless of where they reside—have
access to these services that are a
valuable step toward reducing tobacco
use among the Medicare population.
Another commenter stated that the
proposal would go far in helping many
rural Americans gain access to these
services that they would otherwise not
have.
Response: We agree with the
commenters that adding smoking
cessation services to the list of Medicare
telehealth services will help to provide
greater access to the services for
beneficiaries in rural or other isolated
areas.
After consideration of the public
comments we received, we are
finalizing our CY 2012 proposal to add
CPT codes 99406 and 99407 to the list
of telehealth services for CY 2012 on a
category 1 basis. Additionally, we are
finalizing our proposal to add HCPCS
codes G0436 (Smoking and tobacco
cessation counseling visit for the
asymptomatic patient; intermediate,
greater than 3 minutes, up to 10
minutes) and G0437 (Smoking and
tobacco cessation counseling visit for
the asymptomatic patient; intensive,
greater than 10 minutes) to the list of
telehealth services for CY 2012 and to
revise our regulations at § 410.78(b) and
§ 414.65(a)(1) to include smoking
cessation services as Medicare
telehealth services.
b. Critical Care Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add critical care
service CPT codes 99291 (Critical care,
evaluation and management of the
critically ill or critically injured patient;
first 30–74 minutes) and 99292 (Critical
care, evaluation and management of the
critically ill or critically injured patient;
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each additional 30 minutes) to the list
of approved telehealth services. We
previously received this request for the
CY 2009 and CY 2010 PFS rulemaking
cycles (73 FR 38517, 73 FR 69744 and
69745, 74 FR 33548, and 74 FR 61764)
and did not add the codes on a category
1 basis due to the acute nature of the
typical patient. We continue to believe
that patients requiring critical care
services are more acutely ill than those
patients typically receiving any service
currently on the list of telehealth
services. Therefore, we cannot consider
critical care services on a category 1
basis.
In the CY 2009 PFS proposed rule (73
FR 38517), we explained that we had no
evidence suggesting that the use of
telehealth could be a reasonable
surrogate for the in-person delivery of
critical care services; therefore, we
would not add the services on a
category 2 basis. Requestors submitted
new studies for CY 2012, but none
demonstrated that comparable outcomes
to a face-to-face encounter can be
achieved using telehealth to deliver
these services. The studies we received
primarily addressed other issues
relating to telehealth services. Some
studies addressed the cost benefits and
cost savings of telehealth services.
Others focused on the positive outcomes
of telehealth treatment when compared
with no treatment at all. One submitted
study addressed the equivalency of
patient outcomes for telehealth services
delivered to patients in emergency
rooms, but the study’s authors
specifically restricted their population
to patients whose complaints were not
considered to be genuine emergencies.
Given that limitation, it seems unlikely
that any of these patients would have
required critical care services as defined
by CPT codes 99291 and 99292.
We note that consultations are
included on the list of Medicare
telehealth services and may be billed by
practitioners furnishing services to
critically ill patients These services are
described by the following HCPCS
codes: G0425 (Initial inpatient
telehealth consultation, typically 30
minutes communicating with the
patient via telehealth), G0426 (Initial
inpatient telehealth consultation,
typically 50 minutes communicating
with the patient via telehealth), G0427
(Initial inpatient telehealth consultation,
typically 70 minutes or more
communicating with the patient via
telehealth), G0406 (Follow-up inpatient
telehealth consultation, limited,
physicians typically spend 15 minutes
communicating with the patient via
telehealth), G0407 (Follow-up inpatient
telehealth consultation, intermediate,
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73095
physicians typically spend 25 minutes
communicating with the patient via
telehealth), and G0408 (Follow-up
inpatient telehealth consultation,
complex, physicians typically spend 35
minutes or more communicating with
the patient via telehealth). Critical care
services, as reported by the applicable
CPT codes and described in the
introductory language in the CPT book,
consist of direct delivery by a physician
of medical care for a critically ill or
injured patient, including high
complexity decision-making to assess,
manipulate, and support vital system
functions. Critical care requires
interpretation of multiple physiologic
parameters and/or application of
advanced technologies, including
temporary pacing, ventilation
management, and vascular access
services. The payment rates under the
PFS reflect this full scope of physician
work. To add the critical services to the
telehealth list would require the
physician to be able to deliver this full
scope of services via telehealth. Based
on the code descriptions, we have
previously believed that it is not
possible to deliver the full range of
critical care services without a physical
physician presence with the patient.
We note that there are existing
Category III CPT codes (temporary codes
for emerging services that allow data
collection) for remote real-time
interactive video-conferenced critical
care services that, consistent with our
treatment of other Category III CPT
codes, are not nationally priced under
the PFS. The fact that the CPT Editorial
Panel created these additional Category
III CPT codes suggests to us that these
video-conferenced critical care services
are not the same as the in-person critical
care services requested for addition to
the telehealth list.
Because we did not find evidence that
use of a telecommunications system to
deliver critical care services produces
similar diagnostic or therapeutic
outcomes as compared with the face-toface deliver of the services, we did not
propose to add critical care services (as
described by CPT codes 99291 and
99292) to the list of approved telehealth
services. We reiterated that our decision
not to propose to add critical care
services to the list of approved
telehealth services does not preclude
physicians from furnishing telehealth
consultations to critically ill patients
using the consultation codes that are on
the list of Medicare telehealth services.
Comment: One commenter supported
CMS’s decision not to add critical care
services because the use of a
telecommunications system to deliver
critical services is unlikely to produce
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‘‘similar diagnostic findings or
therapeutic interventions as compared
with the in-person delivery of the same
service.’’
Response: We appreciate this support
for our proposal. As we stated in the CY
2012 PFS proposed rule (76 FR 42843),
none of the submitted requests to add
these services included evidence that
demonstrated delivery via telehealth
resulted in comparable outcomes to inperson care.
Comment: One commenter disagreed
with CMS’ decision not to add critical
care services to the list of Medicare
Telehealth Services. The commenter
argued that because the patient who
requires critical care is more acutely ill
than patients receiving any of the
services currently on the list of
approved codes, these services should
be added to the list. This commenter
also suggested that the proposal to allow
consulting physicians to use the
inpatient telehealth g-codes to report
care of critically ill patients through
telehealth was inappropriate because
not all critically ill patients are
inpatients.
Response: We appreciate and share
the commenter’s concern for beneficiary
access to care. However, we reiterate
that no evidence that we received meets
the criteria to add these services to the
list of Medicare telehealth services.
Regarding the appropriateness of the
telehealth consultation g-codes in the
emergency department setting, we refer
the commenter to section II.E.5. of this
final rule with comment period.
After consideration of the public
comments we received, we are
finalizing our decision not to add
critical care services to the list of
Medicare telehealth services for CY
2012.
c. Domiciliary or Rest Home Evaluation
and Management Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add the following
domiciliary or rest home evaluation and
management CPT codes to the telehealth
list for CY 2012:
• 99334 (Domiciliary or rest home
visit for the evaluation and management
of an established patient, which requires
at least 2 of these 3 key components: A
problem focused interval history; a
problem focused examination; or
straightforward medical decision
making. Counseling and/or coordination
of care with other providers or agencies
are provided consistent with the nature
of the problem(s) and the patient’s
and/or family’s needs. Usually, the
presenting problem(s) are self-limited or
minor. Physicians typically spend 15
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minutes with the patient and/or family
or caregiver).
• 99335 (Domiciliary or rest home
visit for the evaluation and management
of an established patient, which requires
at least 2 of these 3 key components: An
expanded problem focused interval
history; An expanded problem focused
examination; Medical decision making
of low complexity. Counseling and/or
coordination of care with other
providers or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and/or
family’s needs. Usually, the presenting
problem(s) are of low to moderate
severity. Physicians typically spend 25
minutes with the patient and/or family
or caregiver).
• 99336 (Domiciliary or rest home
visit for the evaluation and management
of an established patient, which requires
at least 2 of these 3 key components: A
detailed interval history; a detailed
examination; medical decision making
of moderate complexity. Counseling
and/or coordination of care with other
providers or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and/or
family’s needs. Usually, the presenting
problem(s) are of moderate to high
severity. Physicians typically spend 40
minutes with the patient and/or family
or caregiver).
• 99337 (Domiciliary or rest home
visit for the evaluation and management
of an established patient, which requires
at least 2 of these 3 key components: A
comprehensive interval history; a
comprehensive examination; medical
decision making of moderate to high
complexity. Counseling and/or
coordination of care with other
providers or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and/or
family’s needs. Usually, the presenting
problem(s) are of moderate to high
severity. The patient may be unstable or
may have developed a significant new
problem requiring immediate physician
attention. Physicians typically spend 60
minutes with the patient and/or family
or caregiver).
A domiciliary or rest home is not
permitted under current statute to serve
as an originating site for Medicare
telehealth services. Therefore, we did
not propose to add domiciliary or rest
home evaluation and management
services to the list of Medicare
telehealth services for CY 2012.
Comment: One commenter disagreed
with our proposal not to add
domiciliary or rest home evaluation and
management services because neither
domiciliaries nor rest homes are
permitted under current statue to serve
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as an originating site for Medicare
Telehealth services. The commenter
argued that because CMS added new
ESRD-related G-codes to the list of
approved Medicare Telehealth services
in 2005 despite the fact that dialysis
centers were not then permitted under
statute to serve as originating sites,
CMS’ current reasoning is invalid.
Comment: We acknowledge that we
previously added certain ESRD services
to the list of Medicare telehealth
services when dialysis centers were not
permitted under statute to serve as
telehealth originating sites. However,
the services in question can also be
furnished in sites that were eligible
originating sites when the codes were
added to the list. At this time, we do not
believe that domiciliary or rest home
evaluation and management services
can be furnished outside of
domiciliaries or rest homes.
After consideration of the public
comments we received, we are
finalizing our decision not to add
domiciliary or rest home evaluation and
management services to the list of
Medicare telehealth services for
CY2012.
d. Genetic Counseling Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add CPT code
96040 (Medical genetics and genetic
counseling services, each 30 minutes
face-to-face with patient/family) to the
telehealth list for CY 2012. We note that
CPT guidance regarding reporting
genetic counseling and education
furnished by a physician to an
individual directs physicians to
evaluation and management (E/M) CPT
codes and that services described by
CPT code 96040 are provided by trained
genetic counselors. Physicians and
nonphysician practitioners who may
independently bill Medicare for their
service and who are counseling
individuals would generally report
office or other outpatient evaluation and
management (E/M) CPT codes for office
visits that involve significant
counseling, including genetic
counseling, and these office visit CPT
codes are already on the list of
telehealth services. CPT code 96040
would only be reported by genetic
counselors for genetic counseling
services. These practitioners cannot bill
Medicare directly for their professional
services and they are also not on the list
of practitioners who can furnish
telehealth services (specified in section
1834(m)(4)(E) of the Act). As such, we
do not believe that it would be
necessary or appropriate to add CPT
code 96040 to the list of Medicare
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telehealth services. Therefore, we did
not propose to add genetic counseling
services to the list of Medicare
telehealth services for CY 2012.
Comment: One commenter expressed
concerns about beneficiary access
concerns to genetic counseling but
acknowledged the statutory constraints
faced by CMS.
Response: We appreciate the
commenter’s concerns and their
agreement with our conclusions
regarding our statutory limitations.
After consideration of the public
comments we received, we are
finalizing our decision not to add
genetic counseling services to the list of
Medicare telehealth services for CY
2012.
e. Online Evaluation and Management
Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add CPT code
99444 (Online evaluation and
management service provided by a
physician to an established patient,
guardian, or health care provider not
originating from a related E/M service
provided within the previous 7 days,
using the Internet or similar electronic
communications network) to the list of
Medicare telehealth services.
As we explained in the CY 2008 PFS
final rule with comment period (72 FR
66371), we assigned a status indicator of
‘‘N’’ (Non-covered service) to these
services because: (1) These services are
non-face-to-face; and (2) the code
descriptor includes language that
recognizes the provision of services to
parties other than the beneficiary and
for whom Medicare does not provide
coverage (for example, a guardian).
According to section 1834(m)(2)(A) of
the Act, Medicare is required to pay for
telehealth services at an amount equal
to the amount that a practitioner would
have been paid had such service been
furnished without the use of a
telecommunications system. As such,
we do not believe it would be
appropriate to make payment for
services furnished via telehealth when
those services would not otherwise be
covered under Medicare. Because CPT
code 99444 is currently noncovered, we
did not propose to add online
evaluation and management services to
the list of Medicare Telehealth Services
for CY 2012.
Comment: One commenter argued
that adding online evaluation and
management and other services to the
list of Medicare telehealth services
would support chronic care
management and care coordination. The
same commenter also asserted that
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adding these services would be
administratively easy for CMS to
implement.
Response: While we appreciate the
potential value of maximizing the use of
communication technology in care
coordination and chronic care
management, we cannot consider
adding services that are not otherwise
payable under the physician fee
schedule to the Medicare telehealth
benefit, as defined in 1834 (m) of the
Act. Our decision not to add online
evaluation and management or any
other requested services to the list of
Medicare telehealth services does not
result from concern about
administrative burden.
After consideration of the public
comments we received, we are
finalizing our decision not to add online
evaluation and management services to
the list of Medicare telehealth services
for CY 2012.
f. Data Collection Services
The American Telemedicine
Association and the Marshfield Clinic
submitted requests to add CPT codes
99090 (Analysis of clinical data stored
in computers (e.g., ECGs, blood
pressures, hematologic data)) and 99091
(Collection and interpretation of
physiologic data (e.g., 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,
requiring a minimum of 30 minutes of
time) to the list of Medicare telehealth
services.
As we explained in the in CY 2002
PFS final rule with comment period (66
FR 55309), we assigned a status
indicator of ‘‘B’’ (Payment always
bundled into payment for other services
not specified) to these services because
the associated work is considered part
of the pre- and post-service work of an
E/M service. We note that many E/M
codes are on the list of Medicare
telehealth services.
According to section 1834(m)(2)(A) of
the Act, Medicare is required to pay for
telehealth services an amount equal to
the amount that a practitioner would
have been paid had such service been
furnished without the use of a
telecommunications system. Similar to
the point noted previously for online
E/M services, we do not believe it
would be appropriate to make separate
payment for services furnished via
telehealth when Medicare would not
otherwise make separate payment for
the services. Moreover, we believe the
payment for these data collection
services should be bundled into the
payment for E/M services, many of
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which are already on the Medicare
telehealth list. Because CPT codes
99090 and 99091 are currently bundled,
we did not propose to add data
collection services to the list of
Medicare telehealth services for CY
2012.
Comment: Two commenters argued
that CMS should pay separately for
services like data collection since when
furnished they often mitigate the need
for an in-person visit and in those cases
cannot logically be considered to be
bundled with other services.
Response: We thank the commenters
for conveying their perspective on the
value of such services. However, we
continue to believe it would be
inappropriate to add services that are
not otherwise separately payable under
the physician fee schedule to the
Medicare telehealth benefit, as defined
in 1834 (m) of the Act.
After consideration of the public
comments we received, we are
finalizing our decision not to add data
collection services to the list of
Medicare telehealth services for CY
2012.
g. Audiology Services
The American Academy of Audiology
submitted a request that CMS add
services that audiologists provide for
balance disorders and hearing loss to
the list of Medicare telehealth services.
The request did not include specific
HCPCS codes. Nevertheless, it is not
within our administrative authority to
pay audiologists for services furnished
via telehealth. The statute authorizes the
Secretary to pay for telehealth services
only when furnished by a physician or
a practitioner as physician or
practitioner are defined in sections
1834(m)(4)(D) and (E) of the Act.
Therefore, we did not propose to add
services that are primarily provided by
audiologists to the list of Medicare
telehealth services for CY 2012.
Comment: Several commenters stated
broad support for the value of audiology
services when furnished through
telehealth. These commenters urged
CMS to consider other ways of
implementing programs that allow
audiology services to be furnished
through telehealth.
Response: We appreciate the
commenters’ perspective on the value of
audiology services. The statute
authorizes payment for telehealth
services only when furnished by a
physician or practitioner as defined in
sections 1834(m)(4)(D) and (E) of the
Act. Audiologists do not fall within
either of these definitions, and we do
not believe there is another way to make
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payment to audiologists for telehealth
services.
After consideration of the public
comments we received, we are
finalizing our decision not to add
audiology services to the list of
Medicare telehealth services for CY
2012.
4. The Process for Adding HCPCS Codes
as Medicare Telehealth Services
Along with its submission of codes for
consideration as additions to the
Medicare telehealth list for CY 2012, the
American Telemedicine Association
(ATA) also requested that CMS consider
revising the annual process for adding
to or deleting services from the list of
telehealth services. The existing
process, adopted in the CY 2003 PFS
rulemaking cycle (67 FR 43862 through
43863 and 67 FR 79988 through 79989),
is described in section II.E.1. of this
final rule with comment period. The
following discussion includes a
summary of recent requests by the ATA
and other stakeholders for changes to
the established process for adding
services to the telehealth list, an
assessment of our historical experience
with the current process including the
request review criteria, and our
proposed refinement to the process for
adding services to the telehealth list that
would be used in our evaluation of
candidate telehealth services beginning
for CY 2013.
The ATA asked CMS to consider two
specific changes to the process,
including—
• Broadening the factors for
consideration to include shortages of
health professionals to provide inperson services, speed of access to inperson services, and other barriers to
care for beneficiaries; and
• Equalizing the standard for adding
telehealth services with the standard for
deleting telehealth services by adopting
a standard that allows services that are
safe, effective or medically beneficial
when furnished via telehealth to be
added to the list of Medicare telehealth
services. Similarly, we have received
recommendations that CMS place all
codes payable under the PFS on the
telehealth list and allow physicians and
practitioners to make a clinical
determination in each case about
whether a medically reasonable and
necessary service could be appropriately
furnished to a beneficiary through
telehealth. Under this scenario,
stakeholders have argued that CMS
would only remove services from the
telehealth list under its existing policy
for service removal; specifically, that a
decision to remove a service from the
list of telehealth services would be
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made using evidence-based, peerreviewed data which indicate that a
specific service is not safe, effective, or
medically beneficial when furnished via
telehealth (67 FR 79988).
While we share the interests of
stakeholders in reducing barriers to
health care access faced by some
beneficiaries, given that section
1834(m)(2)(F)(ii) of the Act requires the
Secretary to establish a process that
provides, on an annual basis, for the
addition or deletion of telehealth
services (and HCPCS codes), as
appropriate, we do not believe it would
be appropriate to add all services for
which payment is made under the PFS
to the telehealth list without explicit
consideration as to whether the
candidate service could be effectively
furnished through telehealth. For
example, addition of all codes to the
telehealth list could result in a number
of services on the list that could never
be furnished by a physician or
nonphysician practitioner who was not
physically present with the beneficiary,
such as major surgical procedures and
interventional radiology services.
Furthermore, we do not believe it would
be appropriate to add services to the
telehealth list without explicit
consideration as to whether or not the
nature of the service described by a
candidate code allows the service to be
furnished effectively through telehealth.
Section 1834(m)(2)(A) of the Act
requires that the distant site physician
or practitioner furnishing the telehealth
service must be paid an amount equal
to the amount the physician or
practitioner would have been paid
under the PFS has such service been
furnished without the use of a
telecommunications system. Therefore,
we believe that candidate telehealth
services must also be covered when
furnished in-person; and that any
service that would only be furnished
through a telecommunications system
would be a new service and, therefore,
not a candidate for addition to the
telehealth list. In view of these
considerations, we will continue to
consider candidate additions to the
telehealth list on a HCPCS code-specific
basis based on requests from the public
and our own considerations.
We also believe it continues to be
most appropriate to consider candidate
services for the telehealth list based on
the two mutually exclusive established
categories into which all services fall—
specifically, services that are similar to
services currently on the telehealth list
(category 1) and services that are not
similar to current telehealth services
(category 2). Under our existing policy,
we add services to the telehealth list on
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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 (67 FR
43862). Since CY 2003, we have added
35 services to the telehealth list on a
category 1 basis based on public
requests and our own identification of
such services. We believe it is efficient
and valuable to maintain the existing
policy that allows us to consider
requests for additions to the telehealth
list on a category 1 basis and proposed
to add them to the telehealth list if the
existing criteria are met. This procedure
expedites our ability to identify codes
for the telehealth list that resemble
those services already on this list,
streamlining our review process and the
public request and informationsubmission process for services that fall
into this category. Therefore, we believe
that any changes to the process for
adding codes to the telehealth list
should be considered with respect to
category 2 additions, rather than
category 1 additions.
Our existing criteria for consideration
of codes that would be category 2
additions, specifically those candidate
telehealth services that are not similar to
any current telehealth services, include
an assessment of whether the use of a
telecommunications system to deliver
the services produces similar diagnostic
findings or therapeutic interventions as
compared with a face-to-face in-person
delivery of the same service (67 FR
43682). In other words, the discrete
outcome of the interaction between the
clinician and patient facilitated by a
telecommunications system should
correlate well with the discrete outcome
of the clinician-patient interaction when
performed face-to-face. In the CY 2003
PFS proposed rule (67 FR 43862), we
explained that requestors for category 2
additions to the telehealth list should
submit evidence that the use of a
telecommunications systems does not
affect the diagnosis or treatment plan as
compared to in-person delivery of the
service. We indicated that if evidence
shows that the candidate telehealth
service is equivalent when furnished in
person or through telehealth, we would
add it to the list of telehealth services.
We refer to this standard in further
discussion in this final rule with
comment period as the ‘‘comparability
standard.’’ We stated in the CY 2003
PFS proposed rule (67 FR 43862) that if
we determine that the use of a
telecommunications system changes the
nature or outcome of the service, for
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example, as compared with the inperson delivery of the service, we would
review the telehealth service addition
request as a request for a new service,
rather than a different method of
delivering an existing Medicare service.
For coverage and payment of most
services, Medicare requires that a new
service must: (1) Fall into a Medicare
benefit category; (2) be reasonable and
necessary in accordance with section
1862(a)(1)(A) of the Act; and (3) not be
explicitly excluded from coverage. In
such a case, the requestor would have
the option of applying for a national
coverage determination for the new
service.
We believe it is most appropriate to
address the ATA and other stakeholder
requests to broaden the current factors
we consider when deciding whether to
add candidate services to the telehealth
list—to include factors such as the
effects of barriers to in-person care and
the safety, effectiveness, or medical
benefit of the service furnished through
telehealth, as potential refinements to
our category 2 criteria. We initially
established these category 2 criteria in
the interest of ensuring that the
candidate services were safe, effective,
medically beneficial, and still accurately
described by the corresponding codes
when delivered via telehealth, while
also ensuring that beneficiaries
furnished telehealth services receive
high quality care that is comparable to
in-person care. We believed that the
demonstration of comparable clinical
outcomes (diagnostic findings and/or
therapeutic interventions) from
telehealth and in-person services would
prove to be the best indicator that all of
these conditions were met. While we
continue to believe that safety,
effectiveness, and medical benefit, as
well as accurate description of the
candidate telehealth services by the CPT
or HCPCS codes, are necessary
conditions for adding codes to the list
of Medicare telehealth services, our
recent experience in reviewing public
requests for telehealth list additions and
our discussions with stakeholders
regarding contemporary medical
practice and potential barriers to care,
have led us to conclude that the
comparability standard for category 2
requests should be modified.
In our annual evaluation of category
2 requests since we adopted the process
for evaluating additions to the telehealth
list almost 10 years ago, we have
consistently observed that requestors
have difficulty demonstrating that
clinical outcomes of a service delivered
via telehealth are comparable to the
outcomes of the in-person service. The
medical literature frequently does not
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include studies of the outcomes of many
types of in-person services that allow for
comparison to the outcomes
demonstrated for candidate telehealth
services. Furthermore, we know that in
some cases the alternative to a
telehealth service may be no service
rather than an in-person service. The
comparability standard may not
sufficiently allow for the opportunity to
add candidate services to the telehealth
list that may be safe, effective, and
medically beneficial when delivered via
telehealth, especially to beneficiaries
who experience significant barriers to
in-person care. While we continue to
believe that beneficiaries receiving
services through telehealth are
deserving of high quality health care
and that in-person care may be very
important and potentially preferable for
some services when in-person care is
possible, we are concerned that we have
not added any services to the telehealth
list on a category 2 basis as a result of
our reviews. While some candidate
services appear to have the potential for
clinical benefit when furnished through
telehealth, the requests have not met the
comparability standard.
Therefore, we proposed to refine our
category 2 review criteria for adding
codes to the list of Medicare telehealth
services beginning in CY 2013 by
modifying the current requirement to
demonstrate similar diagnostic findings
or therapeutic interventions with
respect to a candidate service delivered
through telehealth compared to inperson delivery of the service (the
comparability standard). We proposed
to establish a revised standard of
demonstrated clinical benefit when the
service is furnished via telehealth. We
refer to this proposed standard in
further discussion in this final rule with
comment period as the ‘‘clinical benefit
standard.’’ To support our review using
this revised standard, we would ask
requestors to specify in their request
how the candidate telehealth service is
still accurately described by the
corresponding HCPCS or CPT code
when delivered via telehealth as
opposed to in-person.
We proposed that our refined criteria
for category 2 additions would be as
follows:
• Category 2: Services that are not
similar to the current list of telehealth
services. Our review of these requests
would include an assessment of
whether the service is accurately
described by the corresponding code
when delivered via telehealth and
whether the use of a
telecommunications system to deliver
the service produces demonstrated
clinical benefit to the patient.
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Requestors should submit evidence
indicating that the use of a
telecommunications system in
delivering the candidate telehealth
service produces clinical benefit to the
patient.
The evidence submitted 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. 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.
We believe the adoption of this
clinical benefit standard for our review
of candidate telehealth services on a
category 2 basis is responsive to the
requests of stakeholders that we broaden
the factors taken into consideration to
include barriers to care for beneficiaries.
It allows us to consider the
demonstrated clinical benefit of
telehealth services for beneficiaries who
might otherwise have no access to
certain diagnostic or treatment services.
Furthermore, we believe the focus on
demonstrated clinical benefit in our
review of category 2 requests for
addition to the telehealth lists is
equivalent to our standard for deleting
services from the telehealth list that
rests upon evidence that a service is not
safe, not effective, or not medically
beneficial. Finally, we believe the
proposed clinical benefit standard for
our review of candidate telehealth
services on a category 2 basis is fully
consistent with our responsibility to
ensure that telehealth services are safe,
effective, medically beneficial, and still
accurately described by the
corresponding codes that would be used
for the services when delivered inperson.
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We solicited public comments on the
proposed refinement to our established
process for adding codes to the
telehealth list, including the
information that requestors should
furnish to facilitate our full review of
requests in preparation for the CY 2013
PFS rulemaking cycle during which we
will use the category 2 review criteria
finalized in this final rule with
comment period.
Comment: Many commenters
supported the proposal to revise the
category 2 criteria to incorporate the
clinical benefit standard. Many of these
commenters stated that they expect the
revised criteria to result in both an
expanded list of telehealth services and
better medical care for beneficiaries who
might otherwise not have access to
certain diagnostic or treatment services.
Several of these commenters explicitly
stated that the criteria as described in
the proposal presented a rigorous
evidentiary standard for demonstrating
clinical benefit.
Response: We appreciate the broad
support for the proposal. We believe
that the proposed clinical benefit
standard would allow us to consider the
demonstrated clinical benefit of
telehealth services for beneficiaries who
might otherwise have no access to
certain diagnostic or treatment services.
We also believe that the proposal would
ensure that Medicare telehealth services
are safe, effective, and medically
beneficial.
Comment: Some commenters
advocated for eliminating the process
for adding and deleting codes. These
commenters argued that the
determination of which services can be
furnished through telehealth should be
left to the judgment of individual
physicians. One commenter suggested
that CMS should evaluate clinical
equivalence for telemedicine procedures
by limiting the scope to clinical
procedures and interventions that
would normally be performed in the
hospital setting as a part of ongoing
care. A commenting organization
informed CMS that it had conducted an
extensive study of services and
determined a list of services that should
be eligible based on positive correlation
of discrete outcomes of those services
furnished through telehealth and those
same services furnished in-person.
However, the organization did not
provide this analysis with their
comments.
Response: We understand the
commenters’ interests in making
broader changes to the way that services
are added to or deleted from list of
Medicare telehealth services. As we
stated in the proposal, we believe that
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because section 1834(m)(2)(F)(ii) of the
Act requires the Secretary to establish a
process that provides, on an annual
basis, for the addition or deletion of
telehealth services (and HCPCS codes),
as appropriate, we do not believe it
would be appropriate to add all services
for which payment is made under the
PFS to the telehealth list without
explicit consideration as to whether the
candidate service could be effectively
furnished through telehealth.
Furthermore, because section
1834(m)(2)(A) of the Act requires that
the distant site physician or practitioner
furnishing the telehealth service must
be paid an amount equal to the amount
the physician or practitioner would
have been paid under the PFS had such
service been furnished without the use
of a telecommunications system, we do
not believe it would be appropriate to
add services to the telehealth list
without explicit consideration as to
whether or not the nature of the service
described by a candidate code allows
the service to be furnished as effectively
through telehealth as in an in-person
encounter. We believe continuing the
current annual process, with the
proposed amendment to the category 2
criteria, provides the appropriate
opportunity to evaluate whether to add
or delete specific services to the list of
Medicare telehealth services. Although
Medicare has not received many studies
comparing clinical outcomes for inperson and telehealth delivery of the
same service, we encourage
stakeholders that conduct such
comparison studies to submit such
evidence to support category 2 requests
for the addition of particular services to
the list.
Comment: One commenter expressed
support for the proposal but urged CMS
to carefully evaluate its impact if
implemented. That commenter
suggested that the addition of new
services under the proposed standard
could incentivize changes in practice
patterns where Medicare beneficiaries
in remote areas receive consistently a
lower level of care if clinical benefit has
no relationship to the equivalent of an
in-person visit. Another commenter
disagreed with the proposal to amend
the ‘‘comparability standard’’ for adding
services to the list of Medicare
telehealth services. The commenter
asserted that telehealth services can be
effective as a step to help patients get
the care they need, but should not be
used to replace in-person care. The
commenter argued that paying for
telehealth services that may have some
minor benefit as equivalent to an inperson service is misleading to patients
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and would prevent Medicare
beneficiaries from getting the actual inperson care they need.
Response: We appreciate these
concerns and agree that Medicare
beneficiaries in remote areas deserve
access to high quality health care. As we
noted in the proposal, we also believe
that in-person care may be very
important and potentially preferable for
some services when in-person care is
possible. However, we also know that in
some cases the alternative to a
telehealth service may be no service
rather than an in-person service.
We continue to believe safety,
effectiveness, and medical benefit, as
well as accurate description of the
candidate telehealth services by the CPT
or HCPCS codes, are necessary
conditions for adding codes to the list
of Medicare telehealth services. While
we believe that in many cases, the
existing standard has led to appropriate
category 2 determinations not to add
services to the telehealth benefit, we
also believe that the current standard
has prevented consideration of some
services that could be clinically
beneficial because there are no studies
that compare patient outcomes when
services are delivered via telehealth
versus in person. This does not support
our interests in identifying beneficial
services for the telehealth benefit.
Specifically, we observe that the
medical literature frequently does not
include studies of the outcomes of many
types of in-person services that allow for
comparison to the outcomes
demonstrated for candidate telehealth
services. We believe that the proposed
revision to the existing criteria will
allow thorough consideration of a
greater number of requests for addition
to the list. We would also remind
commenters that the annual process will
continue to provide stakeholders who
support or oppose adding particular
services to the list the opportunity to
contribute to our evaluations of
particular requests through public
comment.
Additionally, we note that the
established process for deleting services
from the list would allow Medicare to
consider any available evidence
suggesting that the addition of particular
services to the list of Medicare
telehealth services had detrimentally
changed the quality of medical care for
Medicare beneficiaries in remote areas.
Such evidence could be considered in
the context of either a public request or
internally generated proposal to delete
services from the list of Medicare
telehealth services during annual PFS
rulemaking. This process was
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established during CY 2003 PFS
rulemaking. (67 FR 7988)
Finally, we agree with the commenter
that argued that we should not add
services to the telehealth list based on
demonstrated evidence of minor benefit.
We would like to clarify that our
evidentiary standard of clinical benefit
would not include minor or incidental
benefits.
Comment: Some commenters offered
feedback on the specific kind of
information that requestors should
furnish to facilitate CMS review of
requests to add specific services. One
commenter suggested that CMS should
recognize any biometrics or clinical
parameters known to affect morbidity/
mortality as appropriate supporting
evidence. Another commenter suggested
that CMS should make clear that its list
of clinical benefits that could be
conferred by the use of telehealth
services, as featured in the proposed
rule, is not exhaustive. Rather, the list
is illustrative. The commenter asked
CMS to clarify that there are many kinds
of clinical benefits that are possible for
telehealth services as well as face-toface services, and that CMS will
consider clinical benefits on a case-bycase basis based on studies submitted by
requestors. Another commenter
expressed concern that the proposed
evaluation criteria are inappropriate
since they resemble the criteria for a
Medicare coverage determination.
Response: We agree with the
commenter who stated that the list of
examples of demonstrated clinical
benefits as presented in the proposed
rule (76 FR 42827) is not exhaustive, but
rather illustrative. Furthermore, we
acknowledge that our proposal allows
us to consider clinical benefits on a
case-by-case basis depending on studies
submitted by requestors, our own
internal evaluation, and information
submitted by commenters. While we
acknowledge a similarity between some
of the examples provided in the
proposal and Medicare coverage criteria,
we believe that such resemblance is
appropriate given our interest in
ensuring that services the Secretary
adds to the telehealth benefit
demonstrate clinical benefit to Medicare
beneficiaries.
Comment: Several commenters
requested that CMS provide more
specific information about how the new
criteria will be used to evaluate the
requests to add services to the list of
Medicare telehealth services. One of
these commenters asked CMS to provide
workshops and other outreach efforts
related to the review criteria.
Response: We appreciate the
commenters’ interest in requesting
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greater specificity regarding how the
new criteria will be used in evaluation
of annual requests. In proposing the
new category 2 criteria, we provided
some examples of demonstrated benefit
instead of establishing a series of
specified clinical metrics because we
expect the choice of appropriate
evaluation criteria should be identified
on a case-by-case basis specific to the
information submitted with requests to
add services through the established
annual process.
We believe that establishing more
rigid evaluation criteria (for example,
criteria that rely on measurement of a
series of demonstrated clinical
outcomes specified by CMS) might
present as many problems as has the
current category 2 criteria, because
under such a process requestors would
be required to submit medical literature
that passes a series of hurdles
established by us prior to receiving a
particular request. We would not be able
to assess the benefit of the requested
service within the context of the
submitted evidence and the specific
services. We also believe that such a
process might lead to greater
administrative burden for requestors
and might require constant revision
through annual rulemaking to adapt any
specific criteria to changes in medical
and communication technology as well
as developments in medical literature.
Additionally, we note that the
application of the proposed criteria to
each request will remain subject to
public notice and comment. Since we
implemented the process to add or
delete services, including the existing
category 2 criteria, we have used the
PFS notice and comment rulemaking
process to propose, accept public
comments, and ultimately explain how
the established evaluation criteria apply
to each service we evaluate for addition
to the list of Medicare telehealth
services. We are not proposing a change
to that aspect of the process with this
proposed change in category 2 criteria.
Comment: One commenter expressed
concern regarding the aspect of the
proposed criteria that includes CMS’
review of whether the service is
accurately described by the
corresponding code when delivered via
telehealth. The commenter asserted that
that aspect of the criteria is selffulfilling and might prevent the addition
of otherwise appropriate services to the
list of Medicare telehealth services since
the codes were written to describe inperson services. Similarly, one
commenter was concerned that accurate
description of the code when delivered
via telehealth might prevent CMS from
adding critical care services to the list
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73101
of Medicare telehealth services because
there are category III CPT codes that
describe remote real-time interactive
videoconferenced critical care services.
Response: In general, we do not
believe it would be appropriate to add
services to the Medicare telehealth list
if those services cannot be accurately
described by CPT or HCPCS codes that
could otherwise describe in-person
services. Medicare payment for the
services is based upon the services that
the CPT or HCPCS code describes. As
we explained in the CY 2012 PFS
proposed rule with comment period (76
FR 42826), Section 1834(m)(2)(A) of the
Act requires that the distant site
physician or practitioner furnishing the
telehealth service must be paid an
amount equal to the amount the
physician or practitioner would have
been paid under the PFS had such
service been furnished without the use
of a telecommunications system.
Therefore, we believe that candidate
telehealth services must also be covered
when furnished in-person; that the CPT
and HCPCS code that is the basis for
payment must accurately describe the
service; and that any service that would
only be furnished through a
telecommunications system would be a
distinct service from an in-person
service, and therefore, not a candidate
for addition to the Medicare telehealth
list even when covered by Medicare. For
example, remote services that utilize
telecommunications technology 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 (that is,
without the -GT or -GQ modifier
appended). Medicare coverage for these
types of services is distinct from the
Medicare telehealth benefit.
With regard to the request to add
critical care services to the list of
Medicare telehealth services, the
application of the proposed category 2
criteria to that request is contingent on
both the finalization of the proposed
criteria and our receipt of a new request
to add the services. However, as we
noted in the CY 2012 PFS proposed rule
with comment period (76 FR 42824), the
fact that the CPT Editorial Panel created
the Category III CPT codes suggests to us
that these video-conferenced critical
care services are not the same as the inperson critical care services requested
for addition to the telehealth list.
After consideration of the public
comments we received, we are
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finalizing our proposal to revise the
criteria we use to review category 2
requests to add services to the list of
Medicare telehealth services beginning
in CY 2013. We are modifying the
current requirement to demonstrate
similar diagnostic findings or
therapeutic interventions with respect
to a candidate service delivered through
telehealth compared to in person
delivery of the service (the
comparability standard). Instead, we
will assess category 2 requests to add
services to the telehealth list using a
standard of demonstrated clinical
benefit (the clinical benefit standard)
when the service is furnished via
telehealth. To support our review using
this revised standard, we ask requestors
to specify in their request how the
candidate telehealth service is still
accurately described by the
corresponding HCPCS or CPT code
when delivered via telehealth as
opposed to in person.
Our revised criteria for category 2
additions are as follows:
• Category 2: Services that are not
similar to the current list of telehealth
services. Our review of these requests
will include an assessment of whether
the service is accurately described by
the corresponding code when delivered
via telehealth and whether the use of a
telecommunications system to deliver
the service produces demonstrated
clinical benefit to the patient.
Requestors should submit evidence
indicating that the use of a
telecommunications system in
delivering the candidate telehealth
service produces clinical benefit to the
patient.
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The evidence submitted 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 will 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.
5. Telehealth Consultations in
Emergency Departments
We have recently been asked to clarify
instructions regarding appropriate
reporting of telehealth services that,
prior to our policy change regarding
consultation codes, would have been
reported as consultations furnished to
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patients in an emergency department.
When we eliminated the use of
consultation codes under the PFS
beginning in CY 2010, we instructed
practitioners, when furnishing a service
that would have been reported as a
consultation service, to report the E/M
code that is most appropriate to the
particular service for all office/
outpatient or inpatient visits. Since
section 1834(m) of the Act includes
‘‘professional consultations’’ (including
the initial inpatient consultation codes
‘‘as subsequently modified by the
Secretary’’) in the definition of
telehealth services, we established
several HCPCS codes to describe the
telehealth delivery of initial inpatient
consultations. For inpatient hospital
and skilled nursing facility care
telehealth services, we instructed
practitioners to use the inpatient
telehealth consultation G-codes listed in
Table 12 to report those telehealth
services (74 FR 61763, 61774). However,
we neglected to account for the fact that
E/M emergency department visit codes
(99281–99285) are not on the telehealth
list. As a result, there has not been a
clear means for practitioners to bill a
telehealth consultation furnished in an
emergency department. In order to
address this issue, we proposed to
change the code descriptors for the
inpatient telehealth consultation Gcodes to include emergency department
telehealth consultations effective
January 1, 2012. However, we requested
public comment regarding other
options, including creating G-codes
specific to these services when
furnished to patients in the emergency
department.
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the use of single codes to describe what
can be an inpatient or an outpatient
emergency department service is an
appropriate mechanism to allow
practitioners to report these telehealth
services.
However, the comments regarding site
of service coding distinctions have
prompted us to reconsider the need to
provide a mechanism for follow-up
consultations in the emergency
department. While follow-up
consultative services are furnished to
hospital and SNF inpatients, we do not
believe these services are furnished to
patients in emergency departments
since patients do not spend enough time
in the emergency department to warrant
a second consultative service by the
same practitioner. Therefore, we are
amending our proposal to pertain only
to the G-codes that describe initial
telehealth consultations.
Comment: One commenter disagreed
with the code descriptor change based
on the assertion that the existing Gcodes do not sufficiently cover the
intensity, risk and medical judgment
involved in providing teleICU services
to critically ill patients.
Response: We agree that the telehealth
consultation codes do not fully describe
critical care services. For additional
information regarding the request to add
critical care services to the list of
Medicare telehealth services, we refer
the commenter to our discussion in
section II.E.1.b. of this final rule with
comment period.
Comment: One commenter requested
additional information regarding why
Medicare only pays for consultations
furnished through telehealth.
Response: While Medicare no longer
recognizes CPT consultation codes for
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payment purposes, practitioners
furnishing services that could be
described by CPT consultation codes are
still paid for those services when they
are reported using the the most
appropriate office or inpatient
evaluation and management code. The
telehealth consultation G-codes are
intended to provide a mechanism for
reporting telehealth consultation
services to patients in the inpatient and
SNF settings. We created these codes
because inpatient and SNF evaluation
and management codes were not
included in the telehealth benefit and a
practitioner could not bill an evaluation
and management code when providing
consultation services via telehealth
furnished to patients in those settings.
We refer the reader to our most recent
thorough discussion of this issue in the
CY 2010 PFS final rule with comment
period (74 FR 61763 and 61767 through
61775).
After consideration of the public
comments we received, we are
finalizing our proposal to change the
code descriptors for initial inpatient
telehealth consultation G-codes to
reflect telehealth consultations
furnished to emergency department
patients in addition to inpatient
telehealth consultations effective
January 1, 2012. The descriptors for
these codes for CY 2012 appear in table
13. After consideration of the public
comments we received, we are not
finalizing our proposal to change the
code descriptors for follow-up inpatient
telehealth consultations, since we do
not believe follow-up consultations are
furnished to emergency department
patients.
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Comment: Many commenters
supported the proposal to change the
code descriptors for the inpatient
telehealth consultation G-codes to
include emergency department
telehealth consultations effective
January 1, 2012. These commenters
asserted that changing the code
descriptors is an appropriate way for
CMS to provide a clear means for
practitioners to bill telehealth
consultations furnished to emergency
department patients.
Response: We appreciate the support
for the proposal. We agree that changing
the code descriptors will ensure that
telehealth consultations can be reported
appropriately when furnished to
emergency department patients.
Comment: A few commenters
expressed concerns that the proposal
would blur the line between inpatient
and outpatient services. One commenter
disagreed with the proposal and
suggested that CMS should create new
G-codes since it is important to
maintain the distinction between
outpatient and inpatient services.
Response: We thank the commenters
for bringing these concerns to our
attention. While we understand that
emergency department services are
considered outpatient services, at this
time we believe that allowing
practitioners to report the G-codes we
created for initial inpatient telehealth
consultations when furnishing
telehealth consultations to emergency
department patients is the most
appropriate way to resolve the
immediate issue. We note that the Gcodes we created for telehealth
consultations are used exclusively
under the telehealth benefit. In this
unique circumstance, we believe that
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6. Telehealth Originating Site Facility
Fee Payment Amount Update
percent. Therefore, for CY 2012, the
payment amount for HCPCS code Q3014
(Telehealth originating site facility fee)
is 80 percent of the lesser of the actual
charge or $24.24. The Medicare
telehealth originating site facility fee
and MEI increase by the applicable time
period is shown in Table 14.
III. Addressing Interim Final Relative
Value Units (RVUs) From CY 2011,
Proposed RVUs From CY 2012, and
Establishing Interim RVUs for CY 2012
Under section 1848(c)(2)(B) of the
Act, we review and make adjustments to
RVUs for physicians’ services at least
once every 5 years. Under section
1848(c)(2)(K) of the Act (as added by
section 3134 of the Affordable Care Act),
we are required to identify and revise
RVUs for services identified as
potentially misvalued. Section
1848(c)(2)(K)(iii) specifies that the
Secretary may use existing processes to
receive recommendations on the review
and appropriate adjustment of
potentially misvalued services. In
accordance with section
1848(c)(2)(K)(iii) of the Act, we develop
and propose appropriate adjustments to
the RVUs, taking into account the
recommendations provided by the AMA
RUC, the Medicare Payment Advisory
Commission (MedPAC), and others. To
respond to concerns expressed by
MedPAC, the Congress, and other
stakeholders regarding the accuracy of
values for services under the PFS, the
AMA RUC has used an annual process
to systematically identify, review, and
provide CMS with recommendations for
revised work values for many existing
potentially misvalued services.
For many years, the AMA RUC has
provided CMS with recommendations
on the appropriate relative values for
PFS services. In recent years CMS and
the AMA RUC have taken increasingly
significant steps to address potentially
misvalued codes. In addition to the
Five-Year Reviews of Work, over the
past several years CMS and the AMA
RUC have identified and reviewed a
number of potentially misvalued codes
on an annual basis based on various
identification screens for codes at risk
for being misvalued, such as codes with
high growth rates, codes that are
frequently billed together in one
encounter, and codes that are valued as
inpatient services but that are now
predominantly performed as outpatient
services. This annual review of work
RVUs and direct PE inputs for
potentially misvalued codes was further
bolstered by the Affordable Care Act
mandate to examine potentially
misvalued codes, with an emphasis on
the following categories specified in
section 1848(c)(2)(K)(ii) (as added by
section 3134 of the Affordable Care Act):
• Codes and families of codes for
which there has been the fastest growth.
• Codes or families of codes that have
experienced substantial changes in
practice expenses.
• 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 ‘‘Harvard-valued’’
codes).
• Other codes determined to be
appropriate by the Secretary. (For
example, codes for which there have
been shifts in the site-of-service (site-ofservice anomalies).)
In addition to providing
recommendations to CMS for work
RVUs, the AMA RUC’s Practice Expense
Subcommittee reviews, and then the
AMA RUC recommends, direct PE
inputs (clinical labor, medical supplies,
and medical equipment) for individual
services. To guide the establishment of
malpractice RVUs for new and revised
codes before each Five-Year Review of
Malpractice, the AMA RUC also
provides crosswalk recommendations,
that is, ‘‘source’’ codes with a similar
specialty mix of practitioners furnishing
the source code and the new/revised
code.
CMS reviews the AMA RUC
recommendations on a code-by-code
basis. For AMA RUC recommendations
regarding physician work RVUs, we
determine whether we agree with the
recommended work RVUs for a service
(that is, whether we agree the valuation
is accurate). If we disagree, we
determine an alternative value that
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Section 1834(m)(2)(B) of the Act
establishes the payment amount for the
Medicare telehealth originating site
facility fee for telehealth services
provided from October 1, 2001, through
December 31, 2002, at $20. For
telehealth services provided on or after
January 1 of each subsequent calendar
year, the telehealth originating site
facility fee is increased by the
percentage increase in the MEI as
defined in section 1842(i)(3) of the Act.
The MEI increase for 2012 is 0.6
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better reflects our estimate of the
physician work for the service. Because
of the timing of the CPT Editorial Panel
decisions, the AMA RUC
recommendations, and our rulemaking
cycle, we publish these work RVUs in
the PFS final rule with comment period
as interim final values, subject to public
comment. Similarly, we assess the AMA
RUC’s recommendations for direct PE
inputs and malpractice crosswalks, and
establish PE and malpractice interim
final values, which are also subject to
comment. We note that, with respect to
interim final PE RVUs, the main aspect
of our valuation that is open for public
comment for a new, revised, or
potentially misvalued code is the direct
PE inputs and not the other elements of
the PE valuation methodology, such as
the indirect cost allocation
methodology, that also contribute to
establishing the PE RVUs for a code.
The public comment period on the PFS
final rule with comment period remains
open for 60 days after the rule is issued.
If we receive public comments on the
interim final work RVUs for a specific
code indicating that refinement of the
interim final work value is warranted
based on sufficient information from the
commenters concerning the clinical
aspects of the physician work associated
with the service (57 FR 55917), we refer
the service to a refinement panel, as
discussed in further detail in section
III.B.1.a. of this final rule with comment
period.
In the interval between closure of the
comment period and the subsequent
year’s PFS final rule with comment
period, we consider all of the public
comments on the interim final work, PE,
and malpractice RVUs for the new,
revised, and potentially misvalued
codes and the results of the refinement
panel, if applicable. Finally, we address
the interim final RVUs (including the
interim final direct PE inputs) by
providing a summary of the public
comments and our responses to those
comments, including a discussion of
any changes to the interim final work or
malpractice RVUs or direct PE inputs, in
the following year’s PFS final rule with
comment period. We then typically
finalize the direct PE inputs and the
work, PE, and malpractice RVUs for the
service in that year’s PFS final rule with
comment period, unless we determine it
would be more appropriate to continue
their interim final status for another
year and solicit further public comment.
A. Methodology
We conducted a clinical review of
each code identified in this section and
reviewed the AMA RUC
recommendations for work RVUs, time
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to perform the ‘‘pre-,’’ ‘‘intra-,’’ and
‘‘post-’’ service activities, as well as
other components of the service which
contribute to the value. Our clinical
review generally includes, but is not
limited to, a review of information
provided by the AMA RUC, medical
literature, public comments, and
comparative databases, as well as a
comparison with other codes within the
Medicare PFS, consultation with other
physicians and healthcare care
professionals within CMS and the
Federal Government, and the views
based on clinical experience of the
physicians on the clinical team. We also
assessed the AMA RUC’s methodology
and data used to develop the
recommendations and the rationale for
the recommendations. As we noted in
the CY 2011 PFS final rule with
comment period (75 FR 73328 through
73329), the AMA RUC uses a variety of
methodologies and approaches to assign
work RVUs, including building block,
survey data, crosswalk to key reference
or similar codes, and magnitude
estimation. The building block
methodology is used to construct, or
deconstruct, the work RVU for a CPT
code based on component pieces of the
code. Components may include pre-,
intra-, or post-service time and postprocedure visits, or, when referring to a
bundled CPT code, the components
could be considered to be the CPT codes
that make up the bundled code.
Magnitude estimation refers to a
methodology for valuing physician work
that determines the appropriate work
RVU for a service by gauging the total
amount of physician work for that
service relative to the physician work
for similar service across the physician
fee schedule without explicitly valuing
the components of that work. The
resource-based relative value system
(RBRVS) has incorporated into it crossspecialty and cross-organ system
relativity. This RBRVS requires
assessment of relative value and takes
into account the clinical intensity and
time required to perform a service. In
selecting which methodological
approach will best determine the
appropriate value for a service we
consider the current physician work and
time values, AMA RUC-recommended
physician work and time values, and
specialty society physician work and
time values, as well as the intensity of
the service, all relative to other services.
During our clinical review to assess the
appropriate values for the codes we
developed systematic approaches to
address particular areas of concern.
Specifically, the application of work
budget neutrality within clinical
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categories of CPT codes, CPT codes with
site-of-service anomalies, and CPT
codes for services typically furnished on
the same day as an evaluation and
management visit. A description of
those methodologies follows.
Æ Work Budget Neutrality for Clinical
Categories of CPT Codes
We apply work budget neutrality to
hold the aggregate work RVUs constant
within a set of clinically related CPT
codes, while maintaining the relativity
of values for the individual codes
within that set. In some cases, when the
CPT coding framework for a clinically
related set of CPT codes is revised by
the creation of new CPT codes or
existing CPT codes are revalued, the
aggregate work RVUs recommended by
the AMA RUC within that clinical
category of CPT codes may change,
although the actual physician work
associated with the services has not
changed. When this occurs, we may
apply work budget neutrality to adjust
the work RVUs of each clinically related
code so that the sum of the new/revised
code work RVUs (weighted by projected
utilization) for a set of CPT codes would
be the same as the sum of the current
work RVUs (weighted by projected
utilization) for that set of codes.
When the AMA RUC recommends
work RVUs for new or revised CPT
codes, we review the work RVUs and
adjust or accept the recommended
values as appropriate, making note of
whether any estimated changes in
aggregate work RVUs would result from
true change in physician work, or from
structural coding changes. We then
determine whether the application of
budget neutrality within sets of codes is
appropriate. If the aggregate work RVUs
would increase without a corresponding
true increase in physician work, we
generally view this as an indication that
an adjustment to ensure work budget
neutrality within the set of CPT codes
is warranted. Ensuring work budget
neutrality is an important principle so
that structural coding changes are not
unjustifiably redistributive among PFS
services.
In the CY 2011 PFS final rule with
comment period, there were four sets of
clinically related CPT codes where we
believed that the application of work
budget neutrality was appropriate.
These codes were in the areas of
paraesophageal hernia procedures,
esophageal motility and high resolution
esophageal pressure topography, skin
excision and debridement, and
obstetrical care. The CY 2011 interim
final values and CY 2012 final values for
these services are discussed in section
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III.B.1.b. of this final rule with comment
period.
Æ 23-Hour Stay Site-of-Service Anomaly
CPT Codes
Since CY 2009, CMS and the AMA
RUC have reviewed a number of CPT
codes that have experienced a change in
the typical site-of-service since the
original valuation of the codes.
Specifically, these codes were originally
furnished in the inpatient setting, but
Medicare claims data show that the
typical case has shifted to being
furnished in the outpatient setting. As
we discussed in the CY 2011 PFS final
rule with comment period (75 FR
73221) and the CY 2012 PFS proposed
rule (76 FR 42797), when the typical
case for a service has shifted from the
inpatient setting to an outpatient or
physician’s office setting, we do not
believe the inclusion of inpatient
hospital visits in the post-operative
period is appropriate. Additionally, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
For CY 2009 and CY 2010, the AMA
RUC reviewed and recommended—
RVUs for 40 CPT codes we identified as
being potentially misvalued under the
Secretary’s discretion to identify other
categories of potentially misvalued
codes (see section II.B. of this final rule)
because a site-of-service anomaly exists.
In the CYs 2009 and 2010 PFS final rule
with comment period (73 FR 69883 and
74 FR 61776 through 61778,
respectively), we indicated that
although we would accept the AMA
RUC valuations for these CPT codes on
an interim basis, we had ongoing
concerns about the methodology used
by the AMA RUC to value these
services, and in the CY 2010 PFS final
rule with comment period (74 FR
61777) we encouraged the AMA RUC to
utilize the building block methodology
when revaluing services with site-ofservice anomalies. In the CY 2011 final
rule with comment period (75 FR
73221), we requested that the AMA RUC
re-examine the site-of-service anomaly
codes and adjust the work RVU, times,
and post-service visits to reflect those
typical of a service furnished in an
outpatient or physician’s office setting.
Following this request, the AMA RUC
re-reviewed these site-of-service
anomaly codes and recommended work
RVUs to us for these services. Of the 40
CPT codes on the CY 2009 and CY 2010
site-of-service anomaly codes lists, 1
CPT code was not re-reviewed, as it was
addressed in the CY 2011 PFS final rule
with comment period. Ten of the
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remaining 39 site-of-service anomaly
codes were addressed in the Fourth
Five-Year Review of Work (76 FR
32410), and the remaining 29 CPT codes
were addressed in the CY 2012 PFS
proposed rule (76 FR 72798 through
42809). In addition, several other CPT
codes were identified as having site-ofservice anomalies and were addressed
in the Fourth Five-Year Review of Work
(76 FR 32410). In the CY 2012 PFS
proposed rule (76 FR 42797), we stated
that we would respond to public
comments and adopt final work RVUs
for these codes in the CY 2012 PFS final
rule with comment period.
When Medicare claims data show that
the typical setting for a CPT code has
shifted from the inpatient setting to the
outpatient setting, we believe that the
work RVU, time, and post-service visits
of the code should reflect a service
furnished in the outpatient setting. For
nearly all of the codes with site-ofservice anomalies, the accompanying
survey data suggest they are ‘‘23-hour
stay’’ outpatient services. As we
discussed in detail in the CY 2011 PFS
final rule with comment period (75 FR
73226), the Fourth Five-Year Review of
Work (76 FR 32410) and the CY 2012
PFS proposed rule (76 FR 42798), the
‘‘23-hour stay service’’ is a term of art
describing services that typically have
lengthy hospital outpatient recovery
periods. For these 23-hour stay services,
the typical patient is at the hospital for
less than 24-hours, but often stays
overnight at the hospital. Unless a
treating physician has written an order
to admit the patient as an inpatient, the
patient is considered for Medicare
purposes to be a hospital outpatient, not
an inpatient, and our claims data
support that the typical 23-hour stay
service is billed as an outpatient service.
As we discussed in the Five-Year
Review of Work (76 FR 32410), and CY
2012 PFS proposed rule (76 FR 42798)
we believe that the values of the codes
that fall into the 23-hour stay category
should not reflect work that is typically
associated with an inpatient service.
However, as we stated in the CY 2011
PFS final rule with comment period (75
FR 73226 through 73227), while the
patient receiving the outpatient 23-hour
stay service remains a hospital
outpatient, the patient would typically
be cared for by a physician during that
lengthy recovery period at the hospital.
While we do not believe that postprocedure hospital visits would be at
the inpatient level since the typical case
is an outpatient who would be ready to
be discharged from the hospital in 23hours or less, we believe it is generally
appropriate to include the intra-service
time of the inpatient hospital visit in the
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immediate post-service time of the 23hour stay code under review. In
addition, we indicated that we believe
it is appropriate to include a half day,
rather than a full day, of a discharge day
management service.
We finalized this policy in the CY
2011 PFS final rule with comment
period (75 FR 73226 through 73227) and
applied this methodology when valuing
23-hour stay codes in the Fourth FiveYear Review and CY 2012 PFS proposed
rule in order to ensure the consistent
and appropriate valuation of the
physician work for these services. A full
description of our methodology for
revaluing the site-of-service anomaly
codes can be found in the Fourth FiveYear Review of Work (76 FR 32410), and
the CY 2012 PFS proposed rule (76 FR
72798 through 42809). In brief, where
Medicare claims data suggested a siteof-service anomaly (more than 50
percent of the Medicare PFS utilization
is outpatient) and the AMA RUC’s
recommended value continued to
include inpatient visits in the postoperative period, we removed any postprocedure inpatient visits or subsequent
observation care services included in
the AMA RUC-recommended values for
these codes and adjusted the physician
times accordingly. We also consistently
included the value of a half day of
discharge management service.
Comment: We received a number of
comments that disagreed with the
premise of the 23-hour site-of-service
anomaly methodology arguing that the
acuity of the patient as captured in
patient status (inpatient or outpatient) is
not an indicator of physician work. The
commenters believe that if the
procedure or service is typically
performed in the hospital and the
patient is kept overnight and/or
admitted, the RUC should evaluate it as
an inpatient service or procedure using
the hospital visits as a work proxy
regardless of the patient’s status.
Commenters noted that while
physicians generally write admitting
orders, the hospital frequently makes
the determination to categorize a
patient’s stay as inpatient or outpatient,
and that hospital attention to patient
status is being driven by a fear of
Recover Audit Contractor (RAC) audits
and not clinical judgment. Commenters
asserted that the AMA RUCrecommended values for site-of-service
anomaly codes are based on physician
specialty survey responses which
identified the actual work performed in
caring for these patients and that the
physician work to treat the patient does
not vary with regard to how the patient
is later categorized for facility billing
purposes as an inpatient or outpatient.
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Response: As we noted in the CY
2011 PFS final rule with comment
period (75 FR 73227), these services
would be considered for hospital
outpatient services, not inpatient
services, for the typical patient, and our
claims data support that the typical 23hour stay service, usually a scheduled
procedure, is billed as an outpatient
service. Since the typical patient
commonly remains in the hospital for
less than 24 hours, even if the stay
extends overnight, and the patient’s
encounter is relatively brief, the acuity
of the typical patient and the risk of
adverse outcomes is less than that of a
typical inpatient who is admitted to the
hospital, and we continue to believe
that the intensity of the physician work
involved in caring for the hospital
outpatient immediately following a 23hour stay procedure is less than for a
hospital inpatient. The typical hospital
outpatient for a 23-hour procedure has
fewer comorbidities, less complications,
lower risk and therefore less need for
intensive nursing and physician care of
the kind provided during an inpatient
admission. Medicare pays for an
inpatient admission when, among other
criteria, the physician responsible for
the care of the patient has an
expectation of a minimum 24-hour stay
and the patient requires an inpatient
level of care, based on assessment of
several factors including the severity of
the signs and symptoms and the
probability of an adverse event
(Medicare Benefit Policy Manual 100–
02, chapter 1, section 10).
There are many reasons that services
move from the inpatient to outpatient
setting that reduce the overall risk of
adverse outcomes and intensity of
physician work. Services frequently
move to the outpatient setting when the
technique matures; that is, the riskbenefit ratio of the service is better
understood and the efficacy of the
service is more clearly established.
Services may move to the outpatient
setting because technological advances
decrease the need for intensive
monitoring and allow the discharge of
sicker patients. Patient-controlled
analgesia, for example, reduces the
iterative assessment and response work
necessary to manage post-operative pain
and allows earlier discharge.
Technological advances in the
procedures themselves also reduce the
risk of adverse outcomes. Electronic
imaging and robotic surgery both allow
procedures to be performed with
increasingly smaller incisions,
decreasing post-operative morbidity.
Accordingly, we believe that, generally,
the valuation of the codes that fall into
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the 23-hour stay category should not
reflect physician work that is typically
associated with an inpatient service.
Æ CPT Codes Typically Billed on the
Same Day as an Evaluation and
Management Service
Since CY 2011, we have reviewed a
number of CPT codes that are typically
billed with an E/M service on the same
day. In cases where a service is typically
furnished with an E/M service on the
same day, we believe that there may be
overlap between the two services in
some of the activities conducted during
the pre- and post-service times of the
procedure code. Accordingly, in cases
where the most recently available
Medicare PFS claims data show the
code is typically billed with an E/M
visit on the same day, and where we
believe that the AMA RUC did not
adequately account for overlapping
activities in the recommended value for
the code, we systematically adjusted the
physician times for the code to account
for the overlap. After clinical review of
the pre- and post-service work, we
believe that at least one-third of the
physician time in both the pre-service
evaluation and post-service period is
duplicative of the E/M visit in this
circumstance. Therefore, for a number
of CPT codes discussed in the following
paragraphs, we adjusted the pre-service
evaluation portion of the pre-service
time to two-thirds of the AMA RUCrecommended time. Similarly, we also
adjusted the post-service time to twothirds of the AMA RUC-recommended
time.
B. Finalizing CY 2011 Interim and CY
2012 Proposed Values for CY 2012
In this section, we address the interim
final values published in Appendix C of
the CY 2011 PFS final rule with
comment period (75 FR 73810 through
73815), as subsequently corrected in the
January 11, 2011 (76 FR 1670)
correction notice; the proposed values
published in the Fourth Five-Year
Review of Work (76 FR 32410 through
32813); and the proposed values
published in the CY 2012 PFS proposed
rule (76 FR 42772 through 42947). We
discuss the results of the CY 2011 multispecialty refinement panel, respond to
public comments received on specific
interim final and proposed values
(including direct PE inputs), and
address the other new, revised, or
potentially misvalued codes with
interim final or proposed values. In
section II.B.3. of this final rule with
comment period, we emphasized the
importance of reviewing the full value
for services (the work, PE, and
malpractice components of codes) that
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are identified as part of the potentially
misvalued code initiative in order to
maintain appropriate relativity and key
relationships within the components of
codes. The final CY 2012 direct PE
database that lists the direct PE inputs
is available on the CMS Web site under
the downloads for the CY 2012 PFS
final rule with comment period at:
https://www.cms.gov/
PhysicianFeeSched/. The final CY 2011
work, PE, and malpractice RVUs are
displayed in Addendum B to this final
rule with comment period at: https://
www.cms.gov/PhysicianFeeSched/.
1. Finalizing CY 2011 Interim and
Proposed Work Values for CY 2012
a. Refinement Panel
(1) Refinement Panel Process
As discussed in the 1993 PFS final
rule with comment period (57 FR
55938), we adopted a refinement panel
process 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 that 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 that
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.
Historically, the refinement panel’s
recommendation to change a work value
or to retain the interim value had hinged
solely on the outcome of a statistical test
on the ratings (an F-test of panel ratings
among the groups of participants).
Depending on the number and range of
codes that specialty societies request be
subject to refinement through their
public comments, we establish
refinement panels with representatives
from 4 groups of physicians: Clinicians
representing the specialty most
identified with the procedures in
question; physicians with practices in
related specialties; primary care
physicians; and contractor medical
directors (CMDs). Typically, the
refinement panels meet in the summer
prior to the promulgation of the PFS
final rule with comment period that
finalizes the RVUs for the codes.
Typical panels have included 8 to 10
physicians across the 4 groups. Over
time, we found that the statistical test
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used to evaluate the RVU ratings of
individual panel members became less
reliable as the physicians in each group
have tended to select a previously
discussed value, rather than developing
a unique value, thereby reducing the
observed variability needed to conduct
a robust statistical test. In addition,
reliance on values developed using the
F-test also occasionally resulted in rank
order anomalies among services (that is,
a more complex procedure is assigned
lower RVUs than a less complex
procedure).
Recently, section 1848(c)(2)(K) of the
Act (as added by section 3134 of the
Affordable Care Act) authorized the
Secretary to review potentially
misvalued codes and make appropriate
adjustments to the relative values. In
addition, MedPAC has encouraged CMS
to critically review the values assigned
to the services under the PFS. As
detailed in the CY 2011 PFS final rule
with comment period (75 FR 73306), we
believed the refinement panel process
may provide an opportunity to review
and discuss the proposed and interim
final work RVUs with a clinically
diverse group of experts, which then
provides informed recommendations.
Therefore, we indicated that we would
like to continue the refinement process,
including the established composition
that includes representatives from the 4
groups of physicians, but with
administrative modification and
clarification. We eliminated the use of
the statistical F-test and instead
indicated that we would base revised
RVUs on the median work value of the
individual panel members’ ratings. We
believed this approach would simplify
the refinement process administratively,
while resulting in a final panel
recommendation that reflects the
summary opinion of the panel members
based on a commonly used measure of
central tendency that is not significantly
affected by outlier values. We clarified
that we have the final authority to set
the RVUs, including making
adjustments to the work RVUs resulting
from refinement process if policy
concerns warrant modification (75 FR
73307).
Due to the major increase in the
number of codes reviewed by the CY
2011 multi-specialty refinement panels
as compared to refinement panels in
recent years, and public comments
requesting more clarification about the
refinement panels, we would like to
remind readers that historically the
refinement panels were not intended to
review every code for which we did not
propose to accept the AMA RUCrecommended RVUs. Furthermore, in
the past, we have asked commenters
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requesting refinement panel review to
submit sufficient information
concerning the clinical aspects of the
work assigned for a service to indicate
that referral to the refinement panel is
warranted (57 FR 55917). We note that
the majority of the information that was
presented during the CY 2011
refinement panel discussions was
duplicative of the information provided
to the AMA RUC during its
development of recommendations. As
detailed in section III.B. of this final rule
with comment period, we consider
information and recommendations from
the AMA RUC when assigning proposed
and interim final RVUs to services. To
facilitate the selection of services for the
refinement panels, we would like to
remind specialty societies seeking
reconsideration of proposed or interim
final work RVUs, including
consideration by a refinement panel, to
specifically request refinement panel
review in their public comment letters.
Also, we request that commenters
seeking refinement panel review of
work RVUs submit supporting
information that has not already been
considered by the AMA RUC in creating
recommended work RVUs or by CMS in
assigning proposed and interim final
work RVUs. In order to make the best
use of the agency’s limited resources
and avoid inefficient duplicative
consideration of information by the
AMA RUC, CMS, and then a refinement
panel, CMS will more critically evaluate
the need to refer codes to refinement
panels in future years, specifically
considering any new information
provided by commenters.
(2) Proposed and Interim Final Work
RVUs Referred to the Refinement Panels
in CY 2011
We referred to the CY 2011
refinement panel 143 CPT codes with
proposed or interim final work values
for which we received comments from
least one major specialty society. For
these 143 CPT codes, all commenters
requested increased work RVUs. For
ease of discussion, we will be referring
to these services as ‘‘refinement codes.’’
Consistent with past practice (62 FR
59084), we convened a multi-specialty
panel of physicians to assist us in the
review of the comments. The panel was
moderated by our physician advisors,
and consisted of the following voting
members:
• One to two clinicians representing
the commenting organization;
• One to two primary care clinicians
nominated by the American Academy of
Family Physicians and the American
College of Physicians;
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• One to three contractor medical
directors (CMDs); and
• One to two clinicians with practices
in related specialties who were expected
to have knowledge of the services under
review.
The panel process was designed to
capture each participant’s independent
judgment and his or her clinical
experience which informed and drove
the discussion of the refinement code
during the refinement panel
proceedings. Following the discussion,
each voting participant rated the
physician work of the refinement code.
Ratings were obtained individually and
confidentially, with no attempt to
achieve consensus among the panel
members.
As finalized in the CY 2011 PFS final
rule with comment period (75 FR
73307), we reviewed the ratings from
each panel member and determined the
median value for each service that was
reviewed by the refinement panels. Our
decision to convene multi-specialty
panels of physicians has historically
been based on our need to balance the
interests of those who commented on
the interim final work values with the
redistributive effects that would occur
in other specialties if the work values
were changed. We refer readers to
section III.I. of the CY 2011 PFS final
rule with comment period for a full
discussion of the changes to the
refinement process that we adopted for
refinement panels beginning in CY
2011.
We note that individual codes,
including those that were reviewed by
the refinement panels, and their final
work RVUs are discussed in section
III.B.1.b. of this final rule with comment
period. Also, see Table 15 for the
refinement panel ratings and the final
work RVUs for the codes that were
reviewed by the CY 2011 multispecialty refinement panels.
b. Code-Specific Issues
In this section we discuss all code
families for which we received a
comment on an interim final physician
work value in CY 2011 PFS final rule
with comment period, on a proposed
value in the Fourth Five-Year Review of
Work, or on a proposed value in the CY
2012 PFS proposed rule. Table 15
provides a comprehensive list of all
final values.
(1) Integumentary System: Skin,
Subcutaneous, and Accessory Structures
(CPT codes 10140, 10160, 11010–11012,
11042–11047) and Active Wound Care
Management (CPT codes 97597 and
97598)
For the Fourth Five-Year Review, we
identified CPT codes 10140 and 10160
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as potentially misvalued though the
Harvard-Valued—Utilization > 30,000
screen. The related specialty societies
surveyed their members, and the AMA
RUC issued recommendations to us for
the Fourth Five-Year Review.
As detailed in the Fourth Five-Year
Review, for CPT codes 10140 (Incision
and drainage of hematoma, seroma or
fluid collection) and 10160 (Puncture
aspiration of abscess, hematoma, bulla,
or cyst) we believed that the current (CY
2011) work RVUs continued to
accurately reflect the work of these
services. For CPT code 10140 we
proposed a work RVU of 1.58, and for
CPT code 10160 we proposed a work
RVU of 1.25. The AMA RUC
recommended maintaining the current
work RVUs for these services as well.
For CPT code 10160, the AMA RUC
recommended a pre-service evaluation
time of 7 minutes. As CPT codes 10160
and 10140 have the same description of
pre-service work, we believed that they
should have the same pre-service time.
Therefore, we reduced the pre-service
evaluation time for CPT code 10140
from 17 minutes to 7 minutes, to match
the pre-service evaluation time of CPT
code 10160 (76 FR 32431 through
32432).
Comment: In its public comment to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that there was a
typographical error in its
recommendation to CMS for CPT code
10160, and the correct pre-service
evaluation time for that code should
have been 17 minutes. The AMA RUC
wrote that they agree that CPT codes
10140 and 10160 should have the same
pre-service time, but that both should
have 17 minutes of pre-service
evaluation time, and not 7 minutes.
They requested that CMS change the
pre-service time for both CPT codes
10140 and 10160.
Response: In response to comments,
we re-reviewed CPT codes 10140 and
10160. After reviewing the descriptions
of pre-service work and the
recommended pre-service time
packages, we agree that both CPT codes
10140 and 10160 should have 17
minutes of pre-service evaluation work.
We thank the AMA RUC for pointing
out this time error. For CPT code 10140
we are finalizing a work RVU of 1.50
and a pre-service evaluation time of 17
minutes. For CPT code 10160 we are
finalizing a work RVU of 1.25 and a preservice evaluation time of 17 minutes.
CMS time refinements can be found in
Table 16.
CPT codes 11043 (Debridement; skin,
subcutaneous tissue, and muscle) and
11044 (Debridement; skin, subcutaneous
tissue, muscle, and bone) were
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identified by the AMA RUC’s Five-Year
Review Identification Workgroup
through the ‘‘site-of-service anomalies’’
potentially misvalued codes screen in
September 2007. The AMA RUC
recommended that the entire family of
services described by CPT codes 11040
through 11044, and 97597 and 97598 be
referred to the CPT Editorial Panel
because the current descriptors allowed
reporting of the codes for a bimodal
distribution of patients and also to
better define the terms excision and
debridement. The CPT Excision and
Debridement Workgroup and the CPT
Editorial Panel reviewed and revised the
CPT code descriptors for CPT codes
11042 through 11047, along with the
descriptors for other related CPT codes.
Following the descriptor changes, the
related specialty societies surveyed their
members, gathering information for
work RVU and time recommendations
for these services, and the AMA RUC
issued recommendations to us for CY
2011. We reviewed these CPT codes,
and published the CY 2011 interim final
work RVUs in the CY 2011 PFS final
rule with comment period (75 FR 73329
through 73330). Based on comments
received during the public comment
period, we referred CPT codes 11042
through 11047 to the CY 2011 multispecialty refinement panel for further
review.
As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11042 (Debridement, subcutaneous
tissue (includes epidermis and dermis,
if performed); first 20 sq cm or less) we
assigned a work RVU of 0.80 on an
interim final basis for CY 2011. After
clinical review, we believed that the
then current (2010) work RVU of 0.80
continued to accurately reflect the work
of the service relative to similar
services, including reference CPT code
16020 (Dressings and/or debridement of
partial-thickness burns, initial or
subsequent; small (less than 5 percent
total body surface area)). We found no
grounds to increase the work RVU for
this service. The AMA RUC
recommended a work RVU of 1.12 for
CPT code 11042 for CY 2011 (75 FR
73329).
Comment: Commenters disagreed
with the interim final work RVU of 0.80
assigned to CPT code 11042 by CMS
and believe that the AMA RUCrecommended work RVU of 1.12 is more
appropriate for this service.
Commenters reiterated the arguments
that the specialty societies presented to
the AMA RUC that—(1) the 2005 survey
for this code did not include podiatry,
which is now the dominant specialty for
this service; and (2) the original Harvard
valuation of this code was based on a
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10-day global period, and that since the
original valuation CMS has reduced the
work RVU and changed global period
for this service through the refinement
process in previous years. Commenters
also noted that, while CMS indicated
that the AMA RUC-recommended work
RVU of 1.12 was based on an old
surveyed value, the AMA RUC agreed
that a work RVU of 1.12 continues to be
an appropriate valuation for this service
relative to other services.
Response: Based on the comments
received, we referred CPT code 11042 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11042 was 1.01. As a result of the
refinement panel ratings and our
clinical review, we are assigning a work
RVU of 1.01 to CPT code 11042 as the
final value for CY 2012.
As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11045 (Debridement, subcutaneous
tissue (includes epidermis and dermis,
if performed); each additional 20 sq cm,
or part thereof (List separately in
addition to code for primary procedure))
we assigned a work RVU of 0.33 on an
interim final basis for CY 2011. CPT
code 11045 is the add-on code to CPT
code 11042. To obtain the appropriate
RVU for this add-on service, we started
with the CMS-assigned CY 2011 interim
final RVU of 0.80 for the primary code
(CPT code 11042), and removed the
work RVUs corresponding to the preand post-service time (add-on codes
generally do not have pre- and postservice time because that work is
captured by the primary service). The
AMA RUC recommended a work RVU
of 0.69 for CPT code 11045 for CY 2011
(75 FR 73329 and 73330).
Comment: Commenters disagreed
with the interim final work RVU of 0.33
assigned to CPT code 11045 by CMS
and believe that the AMA RUCrecommended work RVU of 0.69 is more
appropriate for this service.
Commenters noted that removing the
RVUs related to the pre- and postservice time results in a work RVU of
0.34, not a work RVU of 0.33.
Commenters offered reference service
CPT code 36575 (Repair of tunneled or
non-tunneled central venous access
catheter, without subcutaneous port or
pump, central or peripheral insertion
site) to support the AMA RUCrecommended work RVU of 0.69.
Response: Based on the comments
received, we referred CPT code 11045 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11045 was 0.50. As a result of the
refinement panel ratings and our
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clinical review, we are assigning a work
RVU of 0.50 to CPT code 11045 as the
final value for CY 2012.
As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11043 (Debridement, muscle and/or
fascia (includes epidermis, dermis, and
subcutaneous tissue, if performed); first
20 sq cm or less) we assigned a work
RVU of 2.00 on an interim final basis for
CY 2011. After clinical review, we
believed that the work RVU of 2.00 (the
survey low) appropriately reflected the
AMA RUC-recommended decrease in
clinical time and follow-up E/M visits
attributed to the performance of this
service (CY 2010 work RVU=3.14). The
AMA RUC recommended a work RVU
of 3.00 for CPT code 11043 for CY 2011.
(75 FR 73330)
Comment: Commenters disagreed
with the interim final work RVU of 2.00
assigned to CPT code 11043 by CMS
and believe that the AMA RUCrecommended work RVU of 3.00 is more
appropriate for this service.
Commenters noted that the AMA RUCrecommended value for this service
corresponds to the specialty society
survey 25th percentile value, and that
the CMS-assigned value corresponds to
the survey low. Commenters asserted
that CMS ignored the survey results by
selecting the survey low, noting that the
low of any survey could be construed as
an outlier and that they believe it is not
appropriate to value services based on
the survey low.
Response: Based on the comments
received, we referred CPT code 11043 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11043 was 2.70. As a result of the
refinement panel ratings and our
clinical review, we are assigning a work
RVU of 2.70 to CPT code 11043 as the
final value for CY 2012.
As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11046 (Debridement, muscle and/or
fascia (includes epidermis, dermis, and
subcutaneous tissue, if performed); each
additional 20 sq cm, or part thereof (List
separately in addition to code for
primary procedure)) we assigned a work
RVU of 0.70 on an interim final basis for
CY 2011. After clinical review, we
believed that the work RVU of 0.70 (the
survey low) appropriately placed this
add-on service relative to its primary
service, CPT code 11043. The AMA
RUC recommended a work RVU of 1.29
for CPT code 11046 for CY 2011 (75 FR
73330).
Comment: Commenters disagreed
with the interim final work RVU of 0.70
assigned to CPT code 11046 by CMS
and believe that the AMA RUC-
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recommended work RVU of 1.29 is more
appropriate for this service.
Commenters noted that the AMA RUCrecommended value for this service
corresponds to the specialty society
survey 25th percentile value, and that
the CMS-assigned value corresponds to
the survey low. Commenters asserted
that CMS ignored the survey results by
selecting the survey low, noting that the
low of any survey could be construed as
an outlier and that they believe it is not
appropriate to value services based on
the survey low.
Response: Based on the comments
received, we referred CPT code 11046 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11046 was 1.03. As a result of the
refinement panel ratings and our
clinical review, we are assigning a work
RVU of 1.03 to CPT code 11046 as the
final value for CY 2012.
As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11044 (Debridement, bone (includes
epidermis, dermis, subcutaneous tissue,
muscle and/or fascia, if performed); first
20 sq cm or less) we assigned a work
RVU of 3.60 on an interim final basis for
CY 2011. After clinical review, we
believed that the work RVU of 3.60 (the
survey low) appropriately reflected the
AMA RUC-recommended decrease in
clinical time and follow-up E/M visits
attributed to the performance of this
service (CY 2010 work RVU = 4.26). The
AMA RUC recommended a work RVU
of 4.56 for CPT code 11044 for CY 2011
(75 FR 73330).
Comment: Commenters disagreed
with the interim final work RVU of 3.60
assigned to CPT code 11044 by CMS
and believe that the AMA RUCrecommended work RVU of 4.56 is more
appropriate for this service.
Commenters noted that the AMA RUCrecommended value for this service
corresponds to the specialty society
survey 25th percentile value, and that
the CMS-assigned value corresponds to
the survey low. Commenters asserted
that CMS ignored the survey results by
selecting the survey low, noting that the
low of any survey could be construed as
an outlier and that they believe it is not
appropriate to value services based on
the survey low.
Response: Based on the comments
received, we referred CPT code 11044 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11044 was 4.10. As a result of the
refinement panel ratings and our
clinical review, we are assigning a work
RVU of 4.10 to CPT code 11044 as the
final value for CY 2012.
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As detailed in the CY 2011 PFS final
rule with comment period, for CPT code
11047 (Debridement, bone (includes
epidermis, dermis, subcutaneous tissue,
muscle and/or fascia, if performed);
each additional 20 sq cm, or part thereof
(List separately in addition to code for
primary procedure)) we assigned a work
RVU of 1.20 on an interim final basis for
CY 2011. After clinical review, we
believed that the work RVU of 1.20 (the
survey low) appropriately placed this
add-on service relative to its primary
service, CPT code 11044. The AMA
RUC recommended a work RVU of 2.00
for CPT code 11047 for CY 2011 (FR 75
73330).
Comment: Commenters disagreed
with the interim final work RVU of 1.20
assigned to CPT code 11047 by CMS
and believe that the AMA RUCrecommended work RVU of 2.00 is more
appropriate for this service.
Commenters noted that the AMA RUCrecommended value for this service
corresponds to the specialty society
survey 25th percentile value, and that
the CMS-assigned value corresponds to
the survey low. Commenters asserted
that CMS ignored the survey results by
selecting the survey low, noting that the
low of any survey could be construed as
an outlier and that they believe it is not
appropriate to value services based on
the survey low.
Response: Based on the comments
received, we referred CPT code 11047 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU for CPT code
11047 was 1.80. As a result of the
refinement panel ratings and our
clinical review, we are assigning a work
RVU of 1.80 to CPT code 11047 as the
final value for CY 2012.
As stated in the CY 2011 PFS final
rule with comment period (75 FR 73338
and 73339), in the excision and
debridement set of services, for CY 2011
two CPT codes were deleted and the
services that would previously have
been reported under those CPT codes
are now reported under two revised
codes, CPT code 97597 (Debridement
(e.g., high pressure waterjet with/
without suction, sharp selective
debridement with scissors, scalpel and
forceps), open wound, (e.g., fibrin,
devitalized epidermis and/or dermis,
exudate, debris, biofilm), including
topical application(s), wound
assessment, use of a whirlpool, when
performed and instruction(s) for
ongoing care, per session, total
wound(s) surface area; first 20 sq cm or
less) and CPT code 97598 (Debridement
(e.g., high pressure waterjet with/
without suction, sharp selective
debridement with scissors, scalpel and
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wound surface area to describing a
primary procedure and an add-on
procedure that would additionally be
reported in the case of a larger wound.
We believed that the increase in
aggregate work RVUs that would results
from adoption of the RVUs, even after
the adjustments we later discuss, did
not represent a true increase in
physician work for these procedures.
Therefore, we believed it would be
appropriate to apply work budget
neutrality to this set of CPT codes. After
reviewing the HCPAC-recommended
work RVUs, we adjusted the work RVU
for CPT code 97598, and then applied
work budget neutrality to these two CPT
codes, which constitute the set of
clinically related CPT codes. The work
budget neutrality factor for these 2
codes was 0.9422. The HCPACrecommended work RVU, CMS-adjusted
work RVU prior to the budget neutrality
adjustment, and the CY 2011 interim
final work RVU for these skin excision
and debridement codes (CPT code
97597 and 97598) follow.
As mentioned previously, and
detailed in the CY 2011 PFS final rule
with comment period, for CPT code
97598, we disagreed with the HCPACrecommended work RVU of 0.40 and
assigned alternate work RVU of 0.25
prior to the application of work budget
neutrality (75 FR 73330). We believed
that a work RVU of 0.25, which
corresponded to the specialty society
survey low value, was consistent with
new CY 2011 add-on CPT code 11045
(Debridement, subcutaneous tissue
(includes epidermis and dermis, if
performed); each additional 20 sq cm, or
part thereof (List separately in addition
to code for primary procedure)), which
we assigned a CY 2011 interim final
work RVU of 0.33.
Comment: Commenters agreed with
the application of work budget
neutrality to CPT codes 97597 and
97598, and requested that the codes be
re-reviewed after additional claims data
are available to ensure that the
frequency estimates were accurate.
Commenters disagreed with the CMS
pre-budget neutrality work RVU of 0.25
for CPT code 97598 and believed that
the HCPAC-recommended work RVU of
0.40 is more appropriate for this service.
Commenters asserted that CMS ignored
the survey results by selecting the
survey low, noting that the low of any
survey could be construed as an outlier
and that they believe it is not
appropriate to value services based on
the survey low.
Response: Based on the comments
received, we referred CPT codes 97597
and 97598 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel result
supported the HCPAC-recommended
work RVU of 0.54 for CPT code 97597,
and the CY 2011 interim final work
RVU of 0.24 for CPT code 97598. Thus,
the refinement panel result was in line
with the pre-work budget neutrality
work RVU for CPT code 97597, and in
line with the post-work budget
neutrality interim final work RVU for
CPT code 97598. The refinement panel
does not consider whether the
application of work budget neutrality is
appropriate. We continue to believe that
these codes, although revalued, do not
constitute new physician work in
aggregate and that the application of
work budget neutrality is appropriate
for this set of clinically related CPT
codes. Additionally, we continue to
believe that the post-budget neutrality
work RVU of 0.24, which was supported
by the refinement panel result,
appropriately reflects the work
associated with CPT code 97598. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are finalizing a work
RVU of 0.51 for CPT code 97597, and a
work RVU of 0.24 for CPT code 97598
for CY 2012.
For CY 2012, we received no
comments on the CY 2011 interim final
work RVUs of 4.19 for CPT code 11010
(Debridement including removal of
foreign material at the site of an open
fracture and/or an open dislocation (e.g.,
excisional debridement); skin and
subcutaneous tissues), 4.94 for CPT
code 11011(Debridement including
removal of foreign material at the site of
an open fracture and/or an open
dislocation (e.g., excisional
debridement); skin, subcutaneous
tissue, muscle fascia, and muscle), and
6.87 for CPT code 11012 (Debridement
including removal of foreign material at
the site of an open fracture and/or an
open dislocation (e.g., excisional
debridement); skin, subcutaneous
tissue, muscle fascia, muscle, and bone).
We believe these values continue to be
appropriate and are finalizing them
without modification.
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(2) Integumentary System: Nails (CPT
Codes 11732 and 11765)
For the Fourth Five-Year Review, we
identified CPT codes 11732 and 11765
as potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen. The related specialty societies
surveyed their members and the HCPAC
issued recommendations to us for the
Fourth Five-Year Review.
As detailed in the Fourth Five-Year
Review, for CPT code 11732 (Avulsion
of nail plate, partial or complete,
simple; each additional nail plate (List
separately in addition to code for
primary procedure)) we proposed a
work RVU of 0.44, with refinement to
time. After clinical review, we believed
that Multi-Specialty Points of
Comparison (MPC) CPT code 92250
(Fundus photography with
interpretation and report) (work
RVU=0.44) provided an appropriate
crosswalk work RVU for this service.
We found the HCPAC-recommended
decrease in work RVU (from 0.57 to
0.48) to be too small, given the
recommended reduction in time (from
20 minutes total time in CY 2011, to a
recommended 15 minutes total time for
CY 2012). Additionally, we refined the
post-service time for CPT code 11732 to
1 minute, as we believed the HCPACrecommended 3 minutes of post-service
time was excessive for this service (76
FR 32459).
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forceps), open wound, (e.g., fibrin,
devitalized epidermis and/or dermis,
exudate, debris, biofilm), including
topical application(s), wound
assessment, use of a whirlpool, when
performed and instruction(s) for
ongoing care, per session, total
wound(s) surface area; each additional
20 sq cm, or part thereof (List separately
in addition to code for primary
procedure)). These two revised wound
management CPT codes were
restructured from describing two
distinct procedures reported based on
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Comment: Commenters disagreed
with the proposed work RVU of 0.44
assigned to CPT code 11732 by CMS
and believe that the HCPACrecommended work RVU of 0.48 is more
appropriate for this service.
Commenters recommended that CMS
utilize the survey data when valuing
this service rather than a crosswalk
methodology. Commenters noted that
the HCPAC reviewed the survey results
from 38 podiatrists and determined that
the 25th percentile work RVU of 0.48
and total time of 15 minutes
appropriately accounted for the work
and times required to perform this
service. Commenters wrote that the
CMS-proposed reduction in time is
unsubstantiated. Commenters reiterated
the HCPAC recommendation stating that
a work RVU of 0.48 maintains the
proper relativity between this service
and the comparison services of CPT
codes 99212 (Level 3 Office or other
outpatient visit) (work RVU=0.48) and
11721 (Debridement of nail(s) by any
method(s); 6 or more) (work RVU=0.54).
Commenters requested that CMS accept
the HCPAC-recommended work RVU of
0.48 and total time of 15 minutes for
CPT code 11732.
Response: Based on the comments
received, we re-reviewed CPT code
11732. We continue to believe that a
work RVU of 0.44 accurately reflects the
work associated with this service and
that MPC CPT code 92250 is a more
appropriate comparison for this service
than CPT codes 99212 or 11721. After
reviewing the pre-, intra-, and postservice work descriptions for this
service, we continue to believe that the
recommended pre-, and intra- service
times are appropriate, and that the
recommended post-service time is in
excess of the time required to perform
the post-service work. We continue to
believe that one minute of post-service
time is sufficient for this add-on service.
We are maintaining the interim final
value, assigning a work RVU of 0.44,
with 13 minutes of total time, as the
final values for CPT code 11732 for CY
2012. A complete listing of the times
associated with this, and all CPT codes,
is available on the CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/.
As detailed in the Fourth Five-Year
Review, for CPT code 11765 (Wedge
excision of skin of nail fold (e.g., for
ingrown toenail)) we proposed a work
RVU of 1.22, with refinement to time.
We compared CPT code 11765 with
reference CPT code 11422 (Excision,
benign lesion including margins, except
skin tag (unless listed elsewhere), scalp,
neck, hands, feet, genitalia; excised
diameter 1.1 to 2.0 cm) (work
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RVU=1.68), as well as with CPT code
10060 (Incision and drainage of abscess
(e.g., carbuncle, suppurative
hidradenitis, cutaneous or subcutaneous
abscess, cyst, furuncle, or paronychia);
simple or single) (work RVU=1.22), and
determined that CPT code 10060 was
more similar in intensity and
complexity to CPT code 11765, and thus
the better comparator code for this
service. We also refined the time
associated with this service. CPT code
11765 is typically performed on the
same day as an E/M visit and we
believed that some of the activities
conducted during the pre- and postservice times of the procedure code and
the E/M visit overlap. To account for
this overlap, we reduced the pre-service
evaluation and post-service time by one
third (76 FR 32459 through 32460).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
1.22 for CPT code 11765, and believe
that the HCPAC-recommended work
RVU of 1.48 is more appropriate for this
service. Commenters noted that CMS
crosswalked the work RVU for CPT code
11765 to CPT code 10060 which,
commenters pointed out, is a revised
code for this final rule with comment
period. Commenters urged CMS not to
crosswalk CPT code 11765 to CPT code
10060 as it is currently under review
and asserted that a direct crosswalk is
inappropriate when survey data are
available. Commenters also noted that
CY 2009 Medicare claims data indicated
that CPT code 11765 was billed with an
E/M less than 50 percent of the time.
Commenters reiterated the HCPAC
recommendation stating that the HCPAC
compared CPT code 11765 to CPT code
11422 (work RVU=1.68) and noted that
the reference code requires more intraservice time, more mental effort and
judgment, and higher psychological
stress to perform as compared to CPT
code 11765. Ultimately, commenters
requested that CMS accept the HCPACrecommended work RVU of 1.48 and
total time of 59 minutes for CPT code
11765.
Response: Based on comments
received, we re-reviewed CPT code
11765. We continue to believe that a
work RVU of 1.22 accurately reflects the
work associated with this service and
that CPT code 10060 is an appropriate
comparison code for this service. CPT
code 10060 recently was surveyed by
related specialty society members, and
the AMA RUC issued a new
recommendation to us for CPT code
10060 for this final rule with comment
period. As discussed in section III.C.1.b.
of this final rule with comment period
after a review of the new survey results
for 10060, the AMA RUC
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recommendations, and our clinical
review, we are setting an interim final
work RVU of 1.22 for CPT code 10060
for CY 2012, which maintains the
current (CY 2011) value. As such, we
believe that the crosswalk work RVU of
1.22 for CPT code 11765 continues to be
appropriate. For CY 2012 we are
finalizing a work RVU of 1.22 for CPT
code 11765.
In response to commenters’ note that
CPT code 11765 was billed with an
E/M visit less than 50 percent of the
time and therefore, should not be
subject to the same day E/M adjustment,
we looked back at the data for this and
all other Five-Year Review CPT codes
for which we proposed a same day E/
M adjustment. When calculating the
number of times a service was
performed on the same day as an E/M
visit, we likely over-counted multiple
billings of a CPT code and depending on
billing patterns may have identified an
inappropriately higher percentage of
same day E/M billing. We recalculated
these figures using combined
occurrence pairs, which we now believe
is the more appropriate measure of same
day E/M billings for this purpose. We
note that for all codes reviewed for the
CY 2012 PFS proposed and final rules
we used figures calculated based on
combined occurrence pairs. After
recalculating the same day E/M
percentages for the Five-Year Review
CPT codes, CPT code 11765 was the
only code that had originally appeared
to be billed over 50 percent with an
E/M visit, but under the revised
calculation is billed less than 50 percent
with an E/M visit. As such, we no
longer believe it is appropriate to
remove one-third of the pre-service
evaluation time and one-third of the
post service time to account for the
E/M visit on the same date of service.
For CY 2012 we are finalizing the
HCPAC-recommended times of 17
minutes of pre-service evaluation time,
1 minute of pre-service positioning
time, 5 minutes of pre-service dress,
scrub and wait time, 5 minutes of intraservice time, 5 minutes of post-service
time, and 1 CPT code 99212 office or
outpatient visit for CPT code 11765.
(3) Integumentary System: Repair
(Closure) (CPT Codes 11900–11901,
12001–12018, 12031–12057, 13100–
13101, 15120–15121, 15260, 15732,
15823)
In the Fourth Five-Year Review, we
identified CPT codes 12031, 12051,
13101, and 15260 as potentially
misvalued through the HarvardValued—Utilization > 30,000 screen.
CPT codes 12032–12047, 12052–12057,
and 13100 were added as part of the
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family of services for review. Also for
the Fourth Five-Year Review, we
identified CPT code 15732 as
potentially misvalued through the siteof-service anomaly screen. CPT code
15121 was added as part of the family
of services for review. The related
specialty societies surveyed their
members and the AMA RUC issued
recommendations to us for the Fourth
Five-Year Review.
As detailed in the Fourth Five-Year
Review, in its review of this set of CPT
codes, the AMA RUC determined that
the original Harvard-valued work RVUs
led to compression within these code
families, which the AMA RUC
recommended correcting by reducing
the relative values for the smallest
wound size repair codes and increasing
the relative values for the larger wound
size repair codes. Our proposed range of
work RVUs for these CPT codes, while
not as large as the range that would have
resulted from our adoption of the AMA
RUC recommendations, nevertheless is
greater than the current range of work
RVUs for the variety of wound sizes
described by the repair codes (76 FR
32431 through 32432).
For CPT codes 12035 (Repair,
intermediate, wounds of scalp, axillae,
trunk and/or extremities (excluding
hands and feet); 12.6 cm to 20.0 cm),
12036 (Repair, intermediate, wounds of
scalp, axillae, trunk and/or extremities
(excluding hands and feet); 20.1 cm to
30.0 cm), 12037 (Repair, intermediate,
wounds of scalp, axillae, trunk and/or
extremities (excluding hands and feet);
over 30.0 cm), 12045 (Repair,
intermediate, wounds of neck, hands,
feet and/or external genitalia; 12.6 cm to
20.0 cm), 12046 (Repair, intermediate,
wounds of neck, hands, feet and/or
external genitalia; 20.1 cm to 30.0 cm),
12047 (Repair, intermediate, wounds of
neck, hands, feet and/or external
genitalia; over 30.0 cm), 12055 (Repair,
intermediate, wounds of face, ears,
eyelids, nose, lips and/or mucous
membranes; 12.6 cm to 20.0 cm), 12056
(Repair, intermediate, wounds of face,
ears, eyelids, nose, lips and/or mucous
membranes; 20.1 cm to 30.0 cm), and
12057 (Repair, intermediate, wounds of
face, ears, eyelids, nose, lips and/or
mucous membranes; over 30.0 cm), we
proposed specialty society survey 25th
percentile work RVU. The specialty
society surveys of physicians furnishing
these services indicated that the work of
performing these services has not
changed in the past 5 years and that the
complexity of patients requiring the
services has also remained constant.
The survey 25th percentile work RVUs
were somewhat higher than the current
work RVUs for CPT codes 12035–12037,
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12045–12047, 12055 and 12056, and the
survey 25th percentile work RVU for
CPT code 12057 was the same as the
current (CY 2011) work RVU. Given the
survey responses indicating that the
work and complexity of these services
has remained constant, we believed that
adopting the survey 25th percentile
work RVUs both accurately valued the
work associated with these services and
addressed the compression-related
relativity adjustments recommended by
the AMA RUC. For CPT codes 12035–
12037, 12045–12047, and 12055–12057
the AMA RUC recommended the survey
median work RVU, which was higher
than both the current (CY 2011) and
survey 25th percentile work RVU. The
CY 2011, CMS-proposed survey 25th
percentile, and AMA RUCrecommended survey median work
RVUs are listed in Table 15.
In addition to proposed changes to the
AMA RUC-recommended work RVUs
for these services, we also refined the
time associated with several of these
services. For CPT codes 12036, and
12055–12057, we found the survey
median intra-service times to be more
appropriate for these services than the
higher AMA RUC-recommended times.
After clinical review, we believed that
these survey median times accurately
reflected the work associated with
performing these services. We also
refined the times for CPT codes 12046
and 12047. Both CPT codes are typically
performed on the same day as an E/M
visit and we believed that some of the
activities conducted during the pre- and
post- service times of the procedure
code and the E/M visit overlap. To
account for this overlap, we reduced the
pre-service evaluation and post-service
time by one third.
Comment: Commenters disagreed
with the CMS-proposed work RVUs for
CPT codes 12035–12037, 12045–12047,
and 12055–12057, and recommended
that CMS accept the AMA RUCrecommended work RVUs. Commenters
believe that the proposal by CMS to
select the survey 25th percentile survey
value for these codes is flawed because,
since these codes are not provided by a
homogeneous group of providers,
selecting a consistent survey marker
does not ensure relativity between
services. Commenters noted that CMS
stated that use of the 25th percentile
survey value was appropriate because
survey respondents indicated that there
has not been a change in complexity in
these services in the last 5 years.
Commenters asserted that a change in
work was irrelevant, and that the
revaluation was intended to correct
compression within the family of
services. Furthermore, commenters
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73113
noted that the proposed work RVUs
create rank order anomalies between
similar services.
Commenters also disagreed with the
CMS-proposed reductions in time for
CPT codes 12036, 12046–12047, and
12055–12057, and recommended that
CMS accept the AMA RUCrecommended times. For CPT codes
12036, 12055, and 12057 commenters
noted that a significant number of
providers who do not typically perform
the procedure responded to the survey,
resulting in an artificially reduced
median intra-service time. Commenters
asserted that in this case it is more valid
to utilize the results from the providers
with experience performing this service.
For CPT codes 12046 and 12047
commenters asserted that it was not
appropriate for CMS to reduce the preevaluation and post service time to
account for a same day E/M visit.
Commenters noted that these services
have very low utilization, and that the
CMS data showing that these services
are typically billed with an E/M may be
incorrect. Commenters also noted that
the recommended pre-service time for
these two codes was already reduced
from 19 minutes to 13 minutes so they
believed that a further reduction was
not justified.
Response: Based on comments
received, we referred CPT codes 12035–
12037, 12045–12047, and 12055–12057
to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel results largely
supported the AMA RUC-recommended
work RVUs for these services. However,
we are going to maintain the CMSproposed work RVUs and times for
these services as interim, pending the
AMA RUC review of the complex
wound repair codes which we
anticipate will be complete for CY 2013.
Following the receipt of the AMA RUC
recommendations for the complex
wound repair codes, we will reevaluate
the work RVU and times for these
services, especially relative to the
complex wound repair services. With
regards to the accuracy of the same day
E/M data, for this final rule with
comment period, for all the five-year
review CPT codes, we recalculated the
percentage of time they are billed with
an E/M visit using combined occurrence
pairs, as discussed under III.B.1.b.(2). of
this final rule with comment period.
Using a 5 percent sample of CY 2009
Medicare claims data, CPT code 12046
is billed with an E/M visit for 50 percent
of the services, and CPT code 12047 is
billed with an E/M for 60 percent of the
services. Therefore, we continue to
believe that it is appropriate to reduce
the pre-service evaluation and post
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service times by one-third. We recognize
that these services are low volume and
we will take this into consideration
when reevaluating the times and work
RVUs for these codes for CY 2013.
In sum, we are holding as interim for
CY 2012 the Fourth Five-Year Review
proposed work RVUs and times for CPT
codes 12035–12037, 12045–12047, and
12055–12057 (the larger of the
intermediate wound repair services), so
we can review these services alongside
the complex wound repair codes before
finalizing their values. For clarification,
we do not expect that the AMA RUC
would resurvey these codes. For CY
2012 the interim work RVUs are as
follows: A work RVU of 3.50 for CPT
code 12035, a work RVU of 4.23 for CPT
code 12036, a work RVU of 5.00 for CPT
code 12037, a work RVU of 3.75 for CPT
code 12045, a work RVU of 4.30 for CPT
code 12046, a work RVU of 4.95 for CPT
code 12047, a work RVU of 4.50 for CPT
code 12055, a work RVU of 5.30 for CPT
code 12056, and a work RVU of 6.00 for
CPT code 12057. A complete listing of
the times associated with these, and all
CPT codes, is available on the CMS web
site at: https://www.cms.gov/
PhysicianFeeSched/.
As detailed in the Fourth Five-Year
Review, for CPT code 13100 (Repair,
complex, trunk; 1.1 cm to 2.5 cm) and
13101 (Repair, complex, trunk; 2.6 cm
to 7.5 cm) the AMA RUC reviewed the
specialty society survey results and
determined that the current (CY 2011)
work RVUs maintain the appropriate
relativity for these services. We noted
that the AMA RUC reviewed only two
CPT codes in the complex wound repair
family. We agreed with the AMA RUCrecommended work RVUs for these two
services, and requested that, in order to
ensure consistency, the AMA RUC
review the entire set of codes in the
complex wound repair family and
assess the appropriate gradation of the
work RVUs in this family. We
maintained the current (CY 2011) work
RVUs and times for CPT codes 13100
and 13101 pending the AMA RUC
review of the other CPT codes in this
family (76 FR 32434 through 32435).
Comment: Commenters requested that
CMS adopt the AMA RUCrecommended times for CPT codes
13100 and 13101. Commenters believe it
would be unfair to ask the specialty to
re-survey these services and that the
review of other complex repair codes is
unlikely to change the AMA RUCrecommended times for CPT code 13100
and 13101. Commenters note that the
current (CY 2011) Harvard times are
very similar to the AMA RUCrecommended times.
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Response: In response to comments
received, we re-reviewed CPT code
13100 and 13101. While we appreciate
commenters’ assertion that the review of
other complex repair codes is unlikely
to change the AMA RUC-recommended
times for CPT code 13100 and 13101,
we would like to refrain from revising
the current (CY 2011) times and work
RVUs for these codes until we can
review them alongside the other
complex wound repair codes. In the CY
2013 PFS final rule with comment
period, we anticipate publishing interim
final values for CPT codes 13100 and
13101 along with the other complex
wound repair codes.
In the Fourth Five-Year Review (76
FR 32435), we identified CPT codes
15120 and 15732 as potentially
misvalued through the site-of-service
anomaly screen. CPT code 15121 was
added as part of the family of services
for AMA RUC review. In addition, we
identified CPT code 15260 as
potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen. For CPT code 15120 (Splitthickness autograft, face, scalp, eyelids,
mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits; first
100 sq cm or less, or 1 percent of body
area of infants and children (except
15050)), we proposed a work RVU of
10.15 for CY 2012, which was in
agreement with the AMA RUCrecommended work RVU for this CPT
code. Because the most recent Medicare
PFS claims data showed that CPT code
15120 is a code with a site-of-service
anomaly, we adjusted the times in
accordance with the policy discussed in
section III.A. of this final rule with
comment period. Specifically, we
removed the current (CY 2011) 0.5
subsequent hospital care day, added 5
minutes to the immediate post-operative
period, and reduced the discharge day
management service to one-half. These
time changes were reflected in the FiveYear Review physician time file
available on the CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/PFSFRN/. Though
this time refinement was listed in the
physician time file, we unintentionally
did not note this time refinement in the
Fourth Five-Year Review proposed
notice text. As such, we are holding CPT
code 15120 as interim final for CY 2012,
with the previously discussed AMA
RUC-recommended work RVU of 10.15
and the site-of-service time refinement
discussed previously. A complete listing
of the times assigned to CPT code 15120
follow in Table 16.
For CPT code 15732 (Muscle,
myocutaneous, or fasciocutaneous flap;
head and neck (e.g., temporalis,
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masseter muscle, sternocleidomastoid,
levator scapulae)), we proposed a work
RVU of 16.38 for CY 2012, with
refinements to the time. The most recent
Medicare PFS claims data showed that
CPT code 15732 is a code with a siteof-service anomaly. Upon review, it was
clear that this code was being billed for
services furnished to hospital
outpatients, and we had no reason to
believe that miscoding was the main
reason that outpatient settings were the
dominant place of service for this code
in historical PFS claims data. Therefore,
in accordance with the policy discussed
in section III.A. of this final rule with
comment period, we removed the
inpatient hospital visit, reduced the
discharge day management service to
one-half, and adjusted times. These
adjustments resulted in a work RVU of
16.38.
The AMA RUC asserted that claims
data indicating that this service was
furnished in an outpatient setting was
the result of miscoding but, until the
claims data indicate that this service
typically was furnished in the inpatient
setting (greater than 50 percent), we
believed it was inappropriate for the
service to be valued including inpatient
E/M building blocks. We also stated that
we will continue to monitor site-ofservice utilization for this code and may
consider reviewing the work RVU for
this code again in the future if
utilization patterns change (76 FR
32435).
Comment: Commenters disagreed
with the proposed work RVU of 16.38
for CPT code 15732, and supported the
AMA RUC-recommended work RVU of
19.83. Commenters noted that the
proposed value was derived from the
reverse building block methodology,
which removed the subsequent hospital
care codes and reduced the full hospital
discharge day code to a half day.
Commenters stated that the service
described by CPT code 15732 is
furnished in the inpatient setting, and
that data showing otherwise are the
result of miscoding. Commenters noted
that education is still needed for this
family of codes. Commenters noted that
the AMA RUC-recommended value is
more similar to the key reference code
15734 (Muscle, myocutaneous, or
fasciocutaneous flap; trunk) (work
RVU=19.86). Commenters expressed
concerns that the proposed work RVU
will create a rank order anomaly within
the family, and requested that CMS
accept the AMA RUC-recommended
work RVU of 19.83 for CPT code 15732.
Response: Based on comments we
received, we referred CPT code 15732 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
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panel voted for a work RVU of 17.38 for
CPT code 15732. We appreciate
commenters’ interest in physician
education to alleviate the potential for
miscoding. However, the Medicare PFS
data show that this service is typically
furnished in the outpatient setting. We
do not believe it is appropriate for this
now outpatient service to continue to
reflect work that is typically associated
with an inpatient service. As stated
previously, we will continue to monitor
site-of-service utilization for this code
and may consider reviewing the work
RVU for this code again in the future if
utilization patterns change. In order to
ensure consistent and appropriate
valuation of physician work, we are
upholding the application of our
methodology to address 23-hour stay
site-of-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are finalizing a work
RVU of 16.38 for CPT code 15732 and
our proposed refinements to physician
time. CMS time refinements can be
found in Table 16.
For CY 2012, we received no
comments on the CY 2011 interim final
work RVUs for CPT codes 11900, 11901,
12001–12018, and 15823. Additionally,
for CY 2012, we received no comments
on the Fourth Five-Year Review
proposed work RVUs for CPT codes
12041–12044, 12051–12054, 15120,
15121, and 15260. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
(4) Integumentary System: Destruction
(CPT Codes 17250–17286)
In the Fourth Five-Year Review (76
FR 32436), we identified CPT codes
17271, 17272 and 17280 as potentially
misvalued through the HarvardValued—Utilization > 30,000 screen.
The dominant specialty for this family—
dermatology—identified several other
codes in the family to be reviewed
concurrently with these services and
submitted to the AMA RUC
recommendations for CPT codes 17260
through 17286. The AMA RUC
concluded that, with the exception of
one CPT code, 17284, the survey data
validated the current values of the
destruction of skin lesion services. We
agreed with this assessment, with a few
refinements to physician time.
As detailed in the Fourth Five-Year
Review (76 FR 32436), we proposed
work RVUs of 1.37 for CPT codes 17270
(Destruction, malignant lesion (e.g.,
laser surgery, electrosurgery,
cryosurgery, chemosurgery, surgical
curettement), scalp, neck, hands, feet,
genitalia; lesion diameter 0.5 cm or
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less); 1.54 for CPT code 17271
(Destruction, malignant lesion (e.g.,
laser surgery, electrosurgery,
cryosurgery, chemosurgery, surgical
curettement), scalp, neck, hands, feet,
genitalia; lesion diameter 0.6 to 1.0 cm);
and 2.64 for CPT code 17274
(Destruction, malignant lesion (e.g.,
laser surgery, electrosurgery,
cryosurgery, chemosurgery, surgical
curettement), scalp, neck, hands, feet,
genitalia; lesion diameter 3.1 to 4.0 cm)
with refinements to physician time. The
AMA RUC recommended a work RVU
of 1.37 for CPT code 17270, a work RVU
of 1.54 for CPT code 17271, and a work
RVU of 2.64 for CPT code 17274. For
CPT codes 17270, 17271, and 17274, we
believed that the survey median intraservice times accurately reflected the
time required to conduct the intraservice work associated with these
services, the survey median. Therefore,
for CPT code 17270, we increased the
intra-service time from 15 minutes to 16
minutes. For CPT code 17271, we
maintained the intra-service time of 18
minutes, the survey median. For CPT
code 17274, we increased the intraservice time from 32 minutes to 33
minutes.
Comment: In their public comment on
the Fourth Five-Year Review, the AMA
RUC noted that there was a
typographical error in specialty society’s
recommendation to CMS for CPT codes
17270, 17271, and 17274, which the
specialty society later corrected. They
requested that CMS change the intraservice times to the AMA RUCrecommended times of 15 minutes for
CPT code 17270, the corrected 19
minutes for CPT code 17271, and 32
minutes for CPT code 17274.
Response: In response to comments,
we re-reviewed CPT codes 17270,
17271, and 17274. We thank the AMA
RUC for pointing out this time error.
After reviewing the descriptions of
intra-service work, we agree that CPT
codes 17270, 17271, and 17274 should
have 15 minutes, 19 minutes, and
32 minutes of intra-service physician
time, respectively. For CPT code 17270,
we are finalizing a work RVU of 1.37
and an intra-service time of 15 minutes.
For CPT code 17271, we are finalizing
a work RVU of 1.54 and an intra-service
time of 19 minutes. For CPT code
17274, we are finalizing a work RVU of
2.64 and an intra-service time of
32 minutes.
For CY 2012, we received no
comments on the Fourth Five-Year
Review proposed work RVUs for CPT
codes 17250, 17260–17264, 17266,
17272, 17273, 17276, 17280–17284, and
17286. We believe these values continue
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to be appropriate and are finalizing
them without modification (Table 15).
(5) Integumentary System: Breast (CPT
Codes 19302–19357)
In the Fourth Five-Year Review
(76 FR 32437), we identified CPT code
19302 as potentially misvalued through
the site-of-service anomaly screen. For
CPT code 19302 (Mastectomy, partial
(e.g., lumpectomy, tylectomy,
quadrantectomy, segmentectomy); with
axillary lymphadenectomy), we
proposed a work RVU of 13.87. We
agreed with the AMA RUC that CPT
code 19302 is similar in work intensity
and time to CPT code 38745 (Axillary
lymphadenectomy; complete) (work
RVU = 13.87), which overlaps
significantly with CPT code 19302. As
such, we believed these two procedures
should have the same work RVU of
13.87. The AMA RUC recommended a
work RVU of 13.99 for CPT code 19302
(76 FR 32437).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
13.87 for CPT code 19302, and asserted
that the AMA RUC-recommended work
RVU of 13.99 is more appropriate for
this service. Commenters noted that we
compared CPT code 19302 with CPT
code 38745, which has an intra-service
time of 90 minutes. Commenters stated
that the slightly greater intra-service
time of CPT code 19302 supports the
current work RVU of 13.99, and request
that we accept the AMA RUCrecommended work RVU of 13.99.
Response: Based on the comments we
received, we referred CPT code 19302 to
the CY 2011 multi-specialty refinement
panel for further review. Refinement
panel results supported the AMA RUC
recommendation and validated the
current work RVU of 13.99. As a result
of the refinement panel ratings and our
clinical review, for CY 2012 we are
finalizing a work RVU of 13.99 for CPT
code 19302.
For CY 2012, we received no
comments on the Fourth Five-Year
Review proposed work RVU for CPT
code 19357. We believe this value
continue to be appropriate and are
finalizing it without modification (Table
15).
(6) Musculoskeletal: Spine (Vertebral
Column) (CPT Codes 22315, 22520–
22525, 22551, 22552, 22554, 22585, and
22851)
In the Fourth Five-Year Review, we
identified CPT code 22521 as
potentially misvalued through the siteof-service anomaly screen. CMS also
requested that the AMA RUC review
other CPT codes in the family including
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CPT codes 22520, 22522, 22523, 22524
and 22525.
In the Fourth Five-Year Review, we
proposed a work RVU of 8.01 for CPT
code 22521 (Percutaneous
vertebroplasty, 1 vertebral body,
unilateral or bilateral injection; lumbar);
a work RVU of 8.62 for CPT code 22523
(Percutaneous vertebral augmentation,
including cavity creation (fracture
reduction and bone biopsy included
when performed) using mechanical
device, 1 vertebral body, unilateral or
bilateral cannulation (e.g., kyphoplasty);
thoracic); and a work RVU of 8.22 for
CPT code 22524 (Percutaneous vertebral
augmentation, including cavity creation
(fracture reduction and bone biopsy
included when performed) using
mechanical device, 1 vertebral body,
unilateral or bilateral cannulation (e.g.,
kyphoplasty); lumbar). The current
valuation of these codes includes one
full discharge management day
consistent with performance in an
inpatient setting for these services. As
these CPT codes are typically performed
in the outpatient setting, the AMA RUC
recommended, and we agreed, that the
discharge management day should be
reduced by half as this is consistent
with our adjustment methodology for
site-of-service anomaly codes. Although
the AMA RUC reduced the discharge
day management by half, it discovered
that an inadvertent clerical error had led
these codes to appear as if they had
been valued with one full discharge
management day. The AMA RUC stated
that these codes were valued as
outpatient services using only half a
discharge management day during the
2006 Third Five-Year Review of Work
(71 FR 37271). The AMA RUC
concluded that the current (CY 2011)
work RVU for these codes should not be
reduced to reflect the removal of the
half discharge day. The AMA RUC
recommended maintaining the current
work RVU of 8.65 for CPT code 22521,
9.26 for CPT code 22523, and 8.86 for
CPT code 22524 (76 FR 32437).
Comment: Commenters disagreed
with our proposed work RVUs of 8.01
for CPT code 22521, 8.62 for CPT code
22523, and 8.22 for CPT code 22524.
Additionally, commenters stated that
our action to reduce the work RVUs of
codes 22521, 22523 and 22524
disregarded that the AMA RUC
previously had accounted for the
outpatient location in its
recommendation. Moreover,
commenters disagreed with CMS
removing the value of the half discharge
management day which is 0.64 of a
work RVU from each code, and
recommended that we accept the AMA
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RUC-recommended values for these
three CPT codes.
Response: Based on the public
comments received, we referred CPT
codes 22521, 22523, and 22524 to the
CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVUs were 8.65 for
CPT code 22521, 9.04 for CPT code
22523, and 8.54 for CPT code 22524. In
response to the AMA RUC’s comments
on the Fourth Five-Year Review, we rereviewed the Medicare PFS claims data
for CPT codes 22521, 22523, and 22524.
The PFS claims data showed that these
services were utilized in outpatient
settings more than 50 percent of the
time at the time these codes were last
reviewed. These codes are not
considered to be site-of-service anomaly
codes since they were previously valued
as outpatient services. We do not
believe it would be appropriate to apply
our site-of-service methodology of
removing a half discharge day
management (work RVU = 0.64) from
the current (CY 2011) values in this
final rule with comment period. Instead,
we are finalizing the refinement panel
median work RVUs of 8.65 for CPT code
22521, 9.04 for CPT code 22523, and
8.54 for CPT code 22524 for CY 2012.
We received no comments on the CY
2012 proposed work RVUs for CPT
codes 22315, 22520, 22522, and 22525.
We believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
The AMA RUC identified CPT code
22554 (Arthrodesis, anterior interbody
technique, including minimal
discectomy to prepare interspace (other
than for decompression); cervical below
C2) through the ‘‘Codes Reported
Together’’ potentially misvalued code
screen. After review, the AMA RUC
referred CPT code 22554 to the CPT
Editorial Panel to create a new coding
structure for this family of services. For
CY 2011, the CPT Editorial Panel
created 2 new CPT codes—22551
(Arthrodesis, anterior interbody,
including disc space preparation,
discectomy, osteophytectomy and
decompression of spinal cord and/or
nerve roots; cervical below C2) and
22552 (Arthrodesis, anterior interbody,
including disc space preparation,
discectomy, osteophytectomy and
decompression of spinal cord and/or
nerve roots; cervical below C2, each
additional interspace (List separately in
addition to code for separate
procedure)—to describe fusion and
discectomy of the anterior cervical
spine.
In the CY 2011 PFS final rule with
comment period (75 FR 73331), we
assigned a work RVU of 25.00 to CPT
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code 22551 on an interim final basis for
CY 2011. The AMA RUC recommended
a work RVU of 24.50. The specialty
society requested a work RVU of 25.00.
Upon review of the AMA RUCrecommended value and the reference
codes used, it was unclear why the
AMA RUC decided not to accept the
specialty society’s recommended work
RVU of 25.00. We agreed with the
specialty society and believed a work
RVU of 25.00 was appropriate for this
service. We also requested that the
specialty society, with the AMA RUC,
re-review the pre-service times for codes
in this family since concerns were noted
in the AMA RUC recommendation
about the pre-service time for this
service.
We did not receive any public
comments that disagreed with the
interim final work values. Therefore, we
are finalizing a work RVU of 25.00 for
CPT code 22551. For CY 2012, we
received no comments on the CY 2011
interim final work RVUs for CPT codes
22552, 22554, 22585, and 22851. We
believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
(7) Musculoskeletal: Forearm and Wrist
(CPT Codes 25116—25605)
In the Fourth Five-Year Review, we
identified CPT codes 25600 (Closed
treatment of distal radial fracture (e.g.,
Colles or Smith type) or epiphyseal
separation, includes closed treatment of
fracture of ulnar styloid, when
performed; without manipulation) and
25605 (Closed treatment of distal radial
fracture (e.g., Colles or Smith type) or
epiphyseal separation, includes closed
treatment of fracture of ulnar styloid,
when performed; with manipulation) as
potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 25600,
we proposed a work RVU of 2.64 for CY
2012. After clinical review, we believed
that CPT code 25600 required more
work than key reference CPT code
26600 (Closed treatment of metacarpal
fracture, single; without manipulation,
each bone), and found that CPT code
27767 (Closed treatment of posterior
malleolus fracture; without
manipulation) (work RVU = 2.64) is
similar in complexity and intensity to
CPT code 25600. In addition to the work
RVU adjustment for CPT code 25600,
we refined the time associated with this
CPT code. We believed some of the
activities conducted during the pre- and
post-service times of the procedure code
and the E/M visit overlap. Therefore, to
account for this overlap, we refined the
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time for CPT code 25600 by reducing
the pre-service evaluation and post
service time by one-third. Specifically,
we believed that 5 minutes pre-service
evaluation time and 7 minutes postservice time accurately reflect the time
required to conduct the work associated
with this service. The AMA RUC
recommended that CMS continue the
current work RVU of 2.78 for CPT code
25600 (76 FR 32438) based on the
results of a recent survey.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
2.64 for CPT 25600 and believe that the
AMA RUC-recommended work RVU of
2.78 is more appropriate for this service.
Furthermore, the commenters noted that
the AMA RUC and the surveying
specialty societies had already taken
account of pre-operative work by
reducing the specialty society
recommended pre-service time from 9
minutes to 7 minutes. Commenters
noted that AMA RUC submission to
CMS mistakenly failed to allocate the
7 minutes of pre-service time between
pre-service evaluation and pre-service
positioning, and noted that they had
intended to recommend 5 minutes of
pre-service evaluation time and
2 minutes of pre-service positioning
time. They also argued that there is no
overlapping post-operative work
because the patient E/M visit would
have been completed prior to the
surgical service and thus, by definition,
prior to the post-service period. As
such, commenters requested that CMS
accept the clarified pre-service times of
5 minutes for pre-service evaluation and
2 minutes for pre-service positioning, as
well as the recommended 10 minutes of
post-service time. Additionally,
commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU of 2.78.
Response: Based on comments
received, we referred CPT code 25600 to
the CY 2011 multi-specialty refinement
panel for further review. The median
refinement panel work RVU was 2.78.
As a result of the refinement panel
rating and our clinical review, we are
assigning a work RVU of 2.78 to CPT
code 25600 as the final value for CY
2012. In response to comments received
regarding the times associated with CPT
code 25600, we re-reviewed our
proposed pre- and post-service minutes.
We agree with the AMA RUC that
5 minutes of pre-service evaluation
work adequately accounts for the time
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required to furnish this service and
appropriately accounts for the E/M visit
performed on the same day. However,
for the pre-service positioning time, we
believe that 1 minute of pre-service
positioning time, rather than the revised
recommendation of 2 minutes, is
appropriate. CPT code 25605 (Closed
treatment of distal radial fracture (e.g.,
Colles or Smith type) or epiphyseal
separation, includes closed treatment of
fracture of ulnar styloid, when
performed; with manipulation) is
assigned 1 minute of pre-service
positioning time and includes
manipulation, while CPT code 25600 is
used for the same service, but without
manipulation. As such, we do not
believe that CPT code 25600 should
have more pre-service positioning time
than CPT code 25605. Therefore, for
CPT code 25600, we are finalizing a preservice evaluation time of 5 minutes and
a pre-service positioning time of 1
minute.
With regard to the post-service time,
though the procedure described by CPT
code 25600 would occur after the E/M
service, after a review of the post-service
work associated with the E/M visit and
the procedure, we continue to believe
that there is overlap, and that this
overlap was appropriately accounted for
by removing one-third of the postservice minutes from CPT code 25600,
thereby reducing the post-service time
from 10 minutes to 7 minutes. In sum,
for CY 2012 we are finalizing the
refinement panel result median work
RVUs of 2.78 and the following pre- and
post-service times: 5 minutes preservice evaluation time, 1 minute preservice positioning time, and 7 minutes
post-service time for CPT code 25600.
CMS time refinements are listed in
Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 25605,
we proposed a work RVU of 6.00 for CY
2012. After clinical review, including
comparison to CPT code 28113
(Ostectomy, complete excision; fifth
metatarsal head), we believed that an
RVU of 6.00 (the survey low) correctly
reflected relativity across these services.
The AMA RUC recommended a work
RVU of 6.50 for CPT code 25605 for CY
2011 (76 FR 32438). In addition to the
work RVU adjustment for CPT code
25605, we refined the time associated
with this code. Recent Medicare PFS
claims data show that this service is
typically performed on the same day as
an E/M visit. We believed that, in its
time recommendation to us, the AMA
RUC accounted for duplicate E/M work
associated with the pre-service period,
but not the post service period. To
account for this post-service overlap, we
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proposed to reduced the post service
time by one-third.
Comment: Commenters disagreed
with the proposed work RVU of 6.00 for
CPT code 25605 and believe that the
AMA RUC-recommended work RVU of
6.50 is more appropriate. In addition,
commenters noted that the AMA RUCrecommended value for this service
corresponds to the specialty society
survey 25th percentile, whereas the
CMS-assigned value corresponds to the
survey low. Commenters noted that
making a recommendation based on the
survey low value which is potentially
an outlier data point is not statistically
sound methodology and assert that it is
inappropriate to value services based on
the survey low. Furthermore, the
commenters noted that the AMA RUC
and the surveying societies had already
taken account of pre-operative overlap
in work and reduced estimated times
accordingly, and that there is no
overlapping post-operative work
because the patient E/M would have
been completed prior to the surgical
service and thus, by definition, prior to
the post-service period. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Response: Based on comments
received, we referred CPT code 25605 to
the CY 2011 multi-specialty refinement
panel for further review. The median
refinement panel work RVU was 6.25. In
response to comments received
regarding the times associated with CPT
code 25605, we re-reviewed out
proposed pre- and post-service minutes.
We note that we did not propose a
reduction in pre-service minutes from
the AMA RUC-recommended time, and
that we did propose a one-third
reduction in post-service minutes to
account for the same day E/M visit.
After a review of the post-service work
associated with the E/M visit and the
procedure, we continue to believe that
there is overlap, and that this overlap
was appropriately accounted for by
removing one-third of the post-service
minutes from CPT code 25605, thereby
reducing the post-service time from 20
minutes to 13 minutes. In sum, for CY
2012 we are finalizing the refinement
panel result median work RVUs of 6.25
and the following pre- and post-service
times: 14 minutes of pre-service
evaluation time, 1 minute of pre-service
positioning time, 5 minutes of preservice dress, scrub and wait time, and
13 minutes of post-service time for CPT
code 25605. CMS time refinements can
be found in Table 50.
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(8) Musculoskeletal: Femur (Thigh
Region) and Knee Joint (CPT Codes
27385–27530)
In the Fourth Five-Year Review, we
identified CPT codes 27385 and 27530
as potentially misvalued through the
site-of-service anomaly screen.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 27385
(Suture of quadriceps or hamstring
muscle rupture; primary), we proposed
a work RVU of 6.93 for CY 2012.
Medicare PFS claims data indicated that
CPT code 27385 is typically performed
as an outpatient rather than inpatient
service. In accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 27385,
we removed the hospital visit, reduced
the discharge day management service
by one-half, and increased the postservice time to 30 minutes. The AMA
RUC recommended a work RVU of 8.11
for CPT code 27385 (76 FR 32438). The
AMA RUC reviewed the survey results
from physicians who frequently perform
this service and decided that the work
required to perform this service had not
changed. The AMA RUC recommended
that this service be valued as a service
performed predominately in the
inpatient setting, as the survey data
indicated that half of patients have an
overnight stay.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
6.93 for CPT code 27385 and believe
that that AMA RUC-recommended work
RVU of 8.11 is more appropriate for this
service. Commenters asserted that CPT
code 27385 is not a site-of-service
anomaly code because it is utilized
more than 50 percent of the time in the
inpatient setting. Commenters noted
that the CMS value was derived from
the reverse building block methodology,
which removed the subsequent hospital
care code and reduced the full hospital
discharge day management code to a
half day, along with the associated work
RVUs and times. Commenters noted that
the AMA RUC originally valued this
service using magnitude estimation
based on comparison reference codes,
which considers the total work of the
service rather than the work of the
component parts of the service, and
requested CMS accept the AMA RUCrecommended work RVU and physician
time.
Response: Based on the public
comments received, we referred CPT
code 27385 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVU was 7.77 for CPT code 27385.
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The current (CY 2011) work RVU for
this service was developed when this
service was typically furnished in the
inpatient setting. The most recent
Medicare PFS claims data indicates that
this service is now typically furnished
in the outpatient setting. As such, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time and intensity. However,
the AMA RUC-recommendation and
refinement panel results do not reflect a
decrease in physician work. We do not
believe it is appropriate for this
outpatient service to continue to reflect
work that is typically associated with an
inpatient service. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
necessary in the case of CPT code 27385
to apply the methodology, described
previously, to address 23-hour stay siteof-service anomalies. Therefore, we are
finalizing the proposed work RVU of
6.93 for CPT code 27385. Additionally,
we are finalizing a pre-service
evaluation time of 33 minutes, a preservice positioning time of 9 minutes,
pre-service dress, scrub, and wait time
of 15 minutes, an intra-service time of
60 minutes, and a post-service time of
30 minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 27385. CMS time refinements can
be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 27530
(Closed treatment of tibial fracture,
proximal (plateau); without
manipulation), we proposed a work
RVU of 2.65 for CY 2012. Recent
Medicare PFS claims data has shown
that this service is typically performed
on the same day as an E/M visit. We
believed there was some overlap in the
activities conducted during the pre- and
post-service times between the
procedure code and the E/M visit and,
therefore, the time should not be
counted twice in developing the
procedure’s work value. As described
earlier in section III.A. of this final rule
with comment period, to account for
this overlap, we reduced the pre-service
evaluation and post-service time by onethird. We believed that 5 minutes preservice evaluation time and 7 minutes
post-service time accurately reflected
the time required to conduct the work
associated with this service. We also
removed the 2 minutes of pre-service
positioning time, as it does not appear
from the vignette that positioning is
required for a non-manipulated
extremity.
In order to determine the appropriate
work RVU for this service given the time
PO 00000
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changes, we calculated the value of the
extracted time and subtracted it from
the AMA RUC-recommended work
RVU. The AMA RUC recommended a
work RVU of 2.81 for CPT code 27530
(76 FR 32438).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
2.65 for CPT code 27530 and believe
that the AMA RUC-recommended work
RVU of 2.81 is more appropriate for this
service. Commenters disagree with
CMS’ use of the reverse building block
methodology, which reduced pre- and
post-service times because of overlap
with same day E/M services.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested that
CMS accept the AMA RUCrecommended work RVU and physician
time.
Response: Based on the public
comments received, we referred CPT
code 27530 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVU was 2.76 for CPT code 27530.
In response to comments received, we
reviewed the pre- and post- service time
and work for this procedure. We
continue to believe some of the
activities conducted during the pre- and
post-service times of the procedure code
and the E/M visit overlap and should
not be counted in developing this
procedure’s work value. In order to
ensure consistent and appropriate
valuation of physician work, we believe
it is appropriate to apply the
methodology, described previously for
services typically billed in conjunction
with an E/M service, and remove a total
of 7 minutes from the AMA RUCrecommended pre- and post-service
time, which amounts to the removal of
0.16 of a work RVU as described
previously. Therefore, we are finalizing
a work RVU of 2.65 for CPT code 27530.
In addition, after reviewing the
descriptions pre- and post-service work,
we are finalizing a pre-service time of 4
minutes, an intra-service time of 15
minutes, and a post-service time of 7
minutes. CMS time refinements can be
found in Table 16.
(9) Musculoskeletal: Leg (Tibia and
Fibula) and Ankle Joint (CPT Code
27792)
In the Fourth Five-Year Review, we
identified CPT code 27792 (Open
treatment of distal fibular fracture
(lateral malleolus), includes internal
fixation, when performed) as potentially
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misvalued through the site-of-service
anomaly screen. In addition, we
proposed a work RVU of 8.75 for CPT
code 27792. Medicare PFS claims data
indicated that CPT code 27792 is
typically performed in an outpatient
setting. However, the current AMA
RUC-recommended values for this code
reflect work that is typically associated
with an inpatient service. Therefore, in
accordance with our methodology to
address 23-hour stay and site-of-service
anomalies described in section III.A. of
this final rule with comment period, for
CPT code 27792, we removed the
subsequent observation care service,
reduced the discharge day management
service by one-half, and adjusted the
physician times accordingly. For CPT
code 27792, the AMA RUC used
magnitude estimation and
recommended that the current value of
this service, 9.71 RVUs, be maintained;
and the AMA RUC replaced the current
inpatient hospital E/M visit included in
the value with a subsequent observation
care service while maintaining a full
discharge day management service (76
FR 32439).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
8.75 for CPT code 27792 and believe
that that AMA RUC-recommended work
RVU of 9.71 is more appropriate for this
service. Commenters disagreed with
CMS’ use of the reverse building block
methodology, which removed the
subsequent observation care code and
reduced the full hospital discharge day
management code to a half day, along
with the associated work RVUs and
times. Commenters noted that the AMA
RUC originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Response: Based on the public
comments received, we referred CPT
27792 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVU was
9.71, which was consistent with the
AMA RUC recommendation to maintain
the current (CY 2011) work RVU for
CPT code 27792. The current (CY 2011)
work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
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However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply the methodology described
previously to address 23-hour stay siteof-service anomalies. Therefore, we are
finalizing a work RVU of 8.75 for CPT
code 27792. In addition, after reviewing
the descriptions of the pre- and postservice work, we are finalizing a preservice evaluation time of 33 minutes, a
pre-service positioning time of 10
minutes, a pre-service dress, scrub, and
wait time of 15 minutes, an intra-service
time of 60 minutes, and a post-service
time of 30 minutes. We are also
reducing the hospital discharge day by
0.5 for CPT code 27792. CMS time
refinements can be found in Table 16.
(10) Musculoskeletal: Foot and Toes
(CPT Codes 28002–28825)
For the Fourth Five-Year Review, we
identified CPT codes 28002, 28715,
28820 as potentially misvalued though
the site-of-service anomaly screen. CPT
code 28003 was added as a part of the
family of services for review. We also
identified CPT code 28285 as
potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen. The related specialty societies
surveyed these codes and the AMA RUC
issued recommendations to us for the
Fourth Five-Year Review of Work.
CPT codes 28120 and 28122 were
identified in 2007 by the AMA RUC
Relativity Assessment Workgroup as
potentially misvalued through the siteof-service anomaly screen. The related
specialty societies surveyed these codes
and the AMA RUC issued
recommendations to us for CY 2010. As
described in section III.A. of this final
rule with comment period, we accepted
these CY 2010 site-of-service anomaly
code values on an interim basis but
requested that the AMA RUC reexamine the site-of-service anomaly
codes and adjust the work RVUs, times,
and post-operative visits to reflect those
typical of a service furnished in an
outpatient or physician’s office setting.
The AMA RUC re-reviewed the survey
data for these codes and issued
recommendations to us for the Fourth
Five-Year Review of Work.
We reviewed CPT codes 28002–
28003, 28120–21822, 28285, 28715,
28820, and 28825, and published
proposed work RVUs in the Fourth
Five-Year Review of Work (76 FR
PO 00000
Frm 00095
Fmt 4701
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73119
32440). Based on comments received
during the public comment period, we
referred CPT codes 28002, 28120–
21822, 28285, 28715, 28820, and 28825
to the CY 2011 multi-specialty
refinement panel for further review.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28002
(Incision and drainage below fascia,
with or without tendon sheath
involvement, foot; single bursal space),
we proposed a work RVU of 4.00 for CY
2012. After clinical review, including
comparison to CPT code 58353
(Endometrial ablation, thermal, without
hysteroscopic guidance) (work
RVU=3.60), we believed that the survey
low value work RVU of 4.00 accurately
reflected the work associated with this
service. The AMA RUC recommended a
work RVU of 5.34 for CPT code 28002
for CY 2011 (76 FR 32440).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
4.00 for CPT code 28002 and believe
that the AMA RUC-recommended work
RVU of 5.34 is more appropriate for this
service. Commenters disagreed with the
reference service put forward by CMS,
and asserted that the AMA RUC-chosen
reference service is a strong comparison
code. Commenters noted that the AMA
RUC-recommended value for this
service corresponds to the specialty
society survey 25th percentile value,
and that the CMS-assigned value
corresponds to the survey low.
Commenters asserted that establishing a
value based on the survey low, which
potentially is an outlier data point, is
not a statistically sound methodology,
and believe that it is inappropriate to
value services based on the survey low.
Response: Based on the comments
received, we referred CPT code 28002 to
the CY 2011 multi-specialty refinement
panel for further review. The median
refinement panel work RVU was 5.34.
As a result of the refinement panel
ratings and clinical review by CMS, we
are assigning the AMA RUCrecommended work RVU of 5.34 to CPT
code 28002 as the final value for CY
2012. For CY 2012, we received no
comments on the proposed CY 2012
work RVU for CPT code 28003. We
believe this value continues to be
appropriate and are finalizing it without
modification (Table 15).
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28120
(Partial excision (craterization,
saucerization, sequestrectomy, or
diaphysectomy) bone (e.g., osteomyelitis
or bossing); talus or calcaneus), we
proposed a work RVU of 7.31 for CY
2012. Medicare PFS claims data
indicated that CPT code 28120 is
typically performed in an outpatient
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setting. However, the current and AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
previously, for CPT code 28120, we
removed the subsequent observation
care service, reduced the discharge day
management service by one-half, and
adjusted the physician times
accordingly. The AMA RUC
recommended maintaining the current
work RVU of 8.27 for CPT code 28120
for CY 2012 (76 FR 32440).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
7.31 for CPT code 28120 and believe
that the AMA RUC-recommended work
RVU of 8.27 is more appropriate for this
service. Commenters disagreed with
CMS’ use of the reverse building block
methodology, which removed the
subsequent observation care code and
reduced the full hospital discharge
management code to a half day, and the
associated work RVUs and times.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested that
CMS accept the AMA RUCrecommended work RVU and physician
time.
Response: Based on comments
received, we referred CPT code 28120 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 8.27,
which is consistent with the AMA–RUC
recommendation to maintain the current
work RVU for this service. The current
(CY 2011) work RVU for this service
was developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service. After consideration of the
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public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU of 7.31 to CPT
code 28120 as the final value for CY
2012. In addition, after reviewing the
descriptions pre- and post-service work,
we are finalizing a pre-service
evaluation time of 33 minutes, a preservice positioning time of 10 minutes,
a pre-service dress, scrub, and wait time
of 15 minutes, an intra-service time of
50 minutes, and a post-service time of
30 minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 28120. CMS time refinements can
be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28122
(Partial excision (craterization,
saucerization, sequestrectomy, or
diaphysectomy) bone (e.g., osteomyelitis
or bossing); tarsal or metatarsal bone,
except talus or calcaneus), we proposed
a work RVU of 6.76 for CY 2012.
Medicare PFS claims data indicated that
CPT code 28122 is typically performed
in an outpatient setting. However, the
current and AMA RUC-recommended
values for this code reflected work that
is typically associated with an inpatient
service. Therefore, in accordance with
our methodology to address 23-hour
stay and site-of-service anomalies
described previously, for CPT code
28122, we removed the subsequent
observation care service, reduced the
discharge day management service by
one-half, and adjusted the physician
times accordingly. The AMA RUC
recommended maintaining the current
work RVU of 7.72 for CPT code 28122
for CY 2012 (76 FR 32440).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
6.76 for CPT code 28122 and believe
that the AMA RUC-recommended work
RVU of 7.72 is more appropriate for this
service. Commenters noted that the
CMS value was derived from the reverse
building block methodology, which
removed the subsequent observation
care code and reduced the full hospital
discharge management code to a half
day, along with the associated work
RVUs and times. Commenters noted that
the AMA RUC originally valued this
service using magnitude estimation
based on comparison reference codes,
which considers the total work of the
service rather than the work of the
component parts of the service, and
requested that CMS accept the AMA
RUC-recommended work RVU and
physician time.
Response: Based on comments
received, we referred CPT code 28122 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 7.72,
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which was consistent with the AMA
RUC recommendation to maintain the
current work RVU for this service. The
current (CY 2011) work RVU for this
service was developed when this service
was typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service. After consideration of the
public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU of 6.76 to CPT
code 28122 as the final value for CY
2012. In addition, after reviewing the
descriptions of pre- and post-service
work, we are finalizing a pre-service
evaluation time of 33 minutes, a preservice positioning time of 10 minutes,
a pre-service dress, scrub, and wait time
of 15 minutes, an intra-service time of
45 minutes, and a post-service time of
30 minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 28122. CMS time refinements can
be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28285
(correction, hammertoe (e.g.,
interphalangeal fusion, partial or total
phalangectomy), we proposed a work
RVU of 4.76 for CY 2012. The AMA
RUC recommended a work RVU of 5.62
for CPT code 28285. We disagreed with
the AMA RUC-recommended work RVU
for CPT code 28285 and believed that a
work RVU of 4.76, the current work
RVU, was more appropriate for this
service. The majority of survey
respondents indicated that the work of
performing this service has not changed
in the past 5 years (67 percent), and that
there has been no change in complexity
among the patients requiring this
service (81 percent) (76 FR 32440).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
4.76 for CPT code 28285 and believe
that the AMA RUC-recommended work
RVU of 5.62 is more appropriate for this
service. Commenters contend that
compelling evidence for changes in
work, technology, and/or patient
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complexity should not be restricted to
the previous 5 years, and generally that
CPT code 28285 is misvalued because
there has been a change in the way this
procedure is performed today resulting
in more complex and more intense work
as compared to 15 to 20 years ago.
Commenters also noted that the Harvard
study did not involve podiatrists, which
were then and are now the dominant
provider of this service.
Response: Based on the comments
received, we referred CPT code 28285 to
the CY 2011 multi-specialty refinement
panel for further review. The median
refinement panel work RVU was 5.62.
As a result of the refinement panel
ratings and clinical review by CMS, we
are assigning a work RVU of 5.62 to CPT
code 28285 as the final value for CY
2012.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28715
(Arthrodesis; triple), we proposed a
work RVU of 13.42 for CY 2012.
Medicare PFS claims data indicated that
CPT code 28715 is typically performed
in an outpatient setting. However, the
current and AMA RUC-recommended
values for this code reflected work that
is typically associated with an inpatient
service. Therefore, in accordance with
our methodology to address 23-hour
stay and site-of-service anomalies
described previously, for CPT code
28715, we removed the subsequent
hospital care service, reduced the
discharge day management service by
one-half, and adjusted the physician
times accordingly. The AMA RUC
recommended maintaining the current
work RVU of 14.60 for CPT code 28715
for CY 2012 (76 FR 32441).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
13.42 for CPT code 28715 and believe
that the AMA RUC-recommended work
RVU of 14.60 is more appropriate for
this service. Commenters noted that the
CMS value was derived from the reverse
building block methodology, which
removed the subsequent hospital care
code and reduced the full hospital
discharge management code to a half
day, along with the associated work
RVUs and time. Commenters noted that
the AMA RUC originally valued this
service using magnitude estimation
based on comparison reference codes,
which considers the total work of the
service rather than the work of the
component parts of the service, and
requested that CMS accept the AMA
RUC-recommended work RVU and
physician time.
Response: Based on comments
received, we referred CPT code 28715 to
the CY 2011 multi-specialty refinement
panel for further review. The median
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refinement panel work RVU was 14.60,
which was consistent with the AMA
RUC-recommendation to maintain the
current work RVU for this service. The
current (CY 2011) work RVU for this
service was developed when this service
was typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we are believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service. After consideration of the
public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU of 13.42 to CPT
code 28715 as the final value for CY
2012. In addition, after reviewing the
descriptions pre- and post-service work,
we are finalizing a pre-service
evaluation time of 40 minutes, a preservice positioning time of 3 minutes, a
pre-service dress, scrub, and wait time
of 15 minutes, an intra-service time of
125 minutes, and a post-service time of
40 minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 28715. CMS time refinements can
be found in Table 16.
As discussed in the CY 2012 MPFS
proposed rule, for CPT code 28725
(Arthrodesis; subtalar) and 28730
(Arthrodesis, midtarsal or
tarsometatarsal, multiple or transverse),
we proposed work RVUs of 11.22 for
CPT code 28725, and work RVUs of
10.70 for CPT code 28730 respectively.
The most recently available Medicare
claims data suggested that these site-ofservice anomaly codes could be ‘‘23hour stay’’ outpatient services. As
detailed in the CY 2012 MPFS proposed
rule, for CY 2010, CPT codes 28725 and
28730 were identified as potentially
misvalued through the site-of-service
anomaly screen and were reviewed by
the AMA RUC. For both of these
services, based on reference services
and specialty survey data, the AMA
RUC recommended maintaining the
current (CY 2009) work RVU, which
saw a slight increase based on the
redistribution of RVUs that resulted
from the CY 2010 policy to no longer
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73121
recognize the CPT consultation codes
(74 FR 61775). The AMA RUC rereviewed CPT codes 28725 and 28730
for CY 2012 and, contrary to the 23-hour
stay valuation policy we finalized in the
CY 2011 PFS final rule with comment
period (75 FR 73226 through 73227),
recommended replacing the hospital
inpatient post-operative visit in the
current work values with a subsequent
observation care service, specifically
CPT code 99224 (Level 1 subsequent
observation care, per day) and
recommended maintaining the current
interim value for the two CPT codes.
Specifically, for CY 2012 the AMA RUC
recommended a work RVU of 12.18 for
CPT code 28725 and a work RVU of
12.42 for CPT code 28730 (76 FR
42798).
We disagreed with the AMA RUCrecommended values for CPT codes
28725 and 28730. We believed the
appropriate methodology for valuing
these codes entails accounting for the
removal of the inpatient visits in the
work value for the site-of-service
anomaly codes since these services are
no longer typically furnished in the
inpatient setting. We did not believe it
is appropriate to simply exchange the
inpatient post-operative visits in the
original value with subsequent
observation care visits and maintain the
current work RVUs.
Comment: Commenters stated that
just because the patient may be
discharged prior to 24-hours postoperatively does not mean that the postoperative visit would not include the
standard pre-service and post-service
work and instead would only include
intra-service work. Furthermore, the
commenters noted that physicians do
not conduct shorter or less intense
inpatient post-operative visits based on
when the patient may be discharged.
Commenters also stated that CMS is not
consistent in the application of its
methodology of applying intra-service
time and value only. Commenters
encouraged CMS to accept the RUCrecommended values for 28725 and
28730.
Response: Based on the public
comments received, we referred CPT
codes 28725 and 28730 to the CY 2011
multi-specialty refinement panel for
further review. The refinement panel
median work RVU was 12.18 for CPT
code 28725 and 12.42 for CPT code
28730. The current (CY 2011) work
RVUs for these services were developed
based on these services being typically
furnished in the inpatient setting. As
these services are now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
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practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for these services, which are
typically performed on an outpatient
basis, to continue to reflect work that is
typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. Therefore, we are
finalizing a work RVU of 11.22 for CPT
code 28725 and a work RVU of 10.70 for
CPT code 28730 with refinements to
physician time. CMS time refinements
can be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28820
(Amputation, toe; metatarsophalangeal
joint), we proposed a work RVU of 5.82
for CY 2012. Medicare PFS claims data
indicated that CPT code 28820 is
typically performed in an outpatient
setting. However, the current and AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology described previously to
address 23-hour stay and site-of-service
anomalies, for CPT code 28820, we
removed the subsequent hospital care
service, reduced the discharge day
management service to one-half, and
adjusted the physician times
accordingly. The AMA RUC
recommended the survey median work
RVU of 7.00 for CPT code 28820 for CY
2012 (76 FR 32441).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
5.82 for CPT code 28820 and believe
that the AMA RUC-recommended work
RVU of 7.00 is more appropriate for this
service. Commenters disagreed with
CMS’ use of the reverse building block
methodology, which removed the
subsequent hospital care code and
reduced the full hospital discharge
management code to a half day, as well
as the associated work RVUs and time.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested that
CMS accept the AMA RUCrecommended work RVU and physician
time.
Response: Based on comments
received, we referred CPT code 28820 to
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the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 7.00,
which was consistent with the AMA–
RUC recommendation for this service.
The current (CY 2011) work RVU for
this service was developed when this
service was typically furnished in the
inpatient setting, and the CY 2012 AMA
RUC recommendation continued to
include building blocks typical of an
inpatient service. Because we removed
those building blocks, we believe that it
is appropriate to reduce the work RVU
to reflect the reduction in physician
work, as measured by time and
intensity. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU of 5.82 to CPT code 28820 as the
final value for CY 2012. In addition,
after reviewing the descriptions pre- and
post- service work, we are finalizing a
pre-service evaluation time of
33 minutes, a pre-service positioning
time of 10 minutes, a pre-service dress,
scrub, and wait time of 15 minutes, an
intra-service time of 30 minutes, and a
post-service time of 30 minutes. We are
also reducing the hospital discharge day
by 0.5 for CPT code 28820. CMS time
refinements can be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 28825
(Amputation, toe; interphalangeal joint),
we proposed a work RVU of 5.37 for CY
2012. Medicare PFS claims data
indicated that CPT code 28825 is
typically performed in an outpatient
setting. However, the current and AMA
RUC recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
previously, for CPT code 28825, we
reduced the discharge day management
service to one-half, and adjusted the
physician times accordingly. The AMA
RUC recommended maintaining the
current work RVU of 6.01 for CPT code
28825 for CY 2012 (76 FR 32441).
Comment: Commenters disagreed
with the CMS proposed work RVU of
5.37 for CPT code 28825 and believe
that the AMA RUC-recommended work
RVU of 6.01 is more appropriate for this
service. Commenters disagreed with
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CMS’ use of the reverse building block
methodology, which reduced the full
hospital discharge management code to
a half day, along with the associated
work RVUs and time. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested that CMS accept
the AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 28825 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 6.01,
which was consistent with the AMA–
RUC recommendation to maintain the
current work RVU of 6.01 for this
service. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not reflect a
decrease in physician work. We do not
believe it is appropriate for this now
outpatient service to continue to reflect
work that is typically associated with an
inpatient service. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology
described previously to address 23-hour
stay site-of-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU of 5.37 to CPT code 28825 as the
final value for CY 2012. In addition, we
are finalizing a pre-service evaluation
time of 33 minutes, a pre-service
positioning time of 10 minutes, a preservice dress, scrub, and wait time of
15 minutes, an intra-service time of
30 minutes, and a post-service time of
20 minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 28825. CMS time refinements can
be found in Table 16.
(11) Musculoskeletal: Application of
Casts and Strapping (CPT codes 29125–
29916)
In the Fourth Five-Year Review, we
identified CPT code 29125 (Application
of short arm splint (forearm to hand);
static), as potentially misvalued through
the Harvard-Valued-Utilization > 30,000
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screen. CPT codes 29126 (Application of
short arm splint (forearm to hand);
dynamic) and 29425 were added as part
of the family of services for AMA RUC
review.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 29125
(Application of short arm splint
(forearm to hand); static), we proposed
a work RVU of 0.50 for CY 2012.
Medicare PFS claims data affirmed that
this service is typically performed on
the same day as an E/M visit. We
believed some of the activities
conducted during the pre- and postservice times of the procedure code and
the E/M visit overlap and, therefore,
should not be counted twice in
developing the procedure’s work value.
As described earlier in section III.A. to
account for this overlap, we reduced the
pre-service evaluation and post-service
time by one third. We believed that 5
minutes pre-service evaluation time and
3 minutes post-service time accurately
reflect the time required to conduct the
work associated with this service as
described by the CPT code-associated
specialties to the AMA RUC. The AMA
RUC recommended maintaining the
current work RVU of 0.59 for CPT code
29125 (76 FR 32441).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
0.50 for CPT code 29125 and believe
that the AMA RUC-recommended work
RVU of 0.59 is more appropriate.
Commenters noted that the CMS value
was derived from the reverse building
block methodology, which removed the
pre- and post-service time by one-third.
Furthermore, commenters
recommended CMS change our
proposed values for this code and
accept the RUC-recommended value as
the pre-service time and values are
already reduced to account for E/M
work on the same day. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested that CMS accept
the AMA RUC-recommended work RVU
and physician time.
Response: Based on the public
comments received, we referred CPT
29125 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel results agreed with the
CMS-assigned work RVU of 0.50 for
CPT code 29125. Our clinical review
confirmed that this value reflects our
methodology described previously to
reduce the pre-service evaluation and
post-service time by one-third for codes
for which there is typically a same-day
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E/M service. Based on the comments
received, we re-reviewed the pre- and
post-service time and work assigned to
this service. We continue to believe that
there is overlap in the pre- and postservice work between the E/M visit and
service described by CPT code 29125.
We believe that this overlap was
appropriately accounted for by
removing one-third of the pre-service
evaluation minutes, and one-third of the
post service minutes, thereby reducing
the pre-service evaluation time from
7 minutes to 5 minutes, and the postservice time from 5 minutes to 3
minutes. Therefore, for CY 2012 we are
finalizing a work RVU for CPT code
29125 of 0.50, with a pre-service
evaluation time of 5 minutes, and a
post-service time of 3 minutes. CMS
time refinements can be found in Table
16.
As detailed in the Fourth Five-Year
Review of Work, for CPT code 29126
(Application of short arm splint
(forearm to hand); dynamic), we
proposed a work RVU of 0.68 for CY
2012. Medicare PFS claims data
affirmed that this service is typically
performed on the same day as an E/M
visit. We believed some of the activities
conducted during the pre- and postservice times of the procedure code and
the E/M visit overlap and, therefore,
should not be counted twice in
developing the procedure’s work value.
As described earlier in section III.A. of
this final rule with comment period, to
account for this overlap, we reduced the
pre-service evaluation and post-service
time by one-third. The AMA RUC
recommended maintaining the current
work RVU of 0.77 for CPT code 29126
(76 FR 32442).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
0.68 for CPT code 29126 and believe
that the AMA RUC-recommended work
RVU of 0.77 is more appropriate.
Commenters noted that the CMS value
was derived from the reverse building
block methodology, which reduced the
pre- and post service time by one-third.
Furthermore, commenters
recommended CMS change the
proposed values for this code and
accept the RUC-recommended values
because, commenters asserted, the AMA
RUC-recommended pre-service time as
values were already reduced to account
for E/M work on the same day.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested that
CMS accept the AMA RUC-
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recommended work RVU and physician
time.
Response: Based on the comments
received, we referred CPT code 29126 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 0.77,
which supported the AMA RUC
recommendation to maintain the current
work RVU for this service. Based on the
comments received, we re-reviewed the
pre- and post-service time and work
assigned to this service. We continue to
believe that there is overlap in the preand post-service work between the E/M
visit and service described by CPT code
29126. We believe that this overlap was
appropriately accounted for by
removing one-third of the pre-service
evaluation minutes, and one-third of the
post service minutes, thereby reducing
the pre-service evaluation time from 7
minutes to 5 minutes, and the postservice time from 5 minutes to 3
minutes. We do not believe it is
appropriate for the work RVU of this
service to reflect the aforementioned
overlap in pre- and post-service work
between the E/M visit and the service
described by CPT code 29126.
Therefore, for CY 2012 we are finalizing
the proposed work RVU of 0.68, with a
pre-service evaluation time of 5
minutes, and a post-service time of
3 minutes. CMS time refinements can be
found in Table 16.
As detailed in the Fourth Five-Year
Review, for CPT code 29515
(Application of short leg splint (calf to
foot)) we believed that the current (CY
2011) work RVU continued to
accurately reflect the work of this
service. For CPT code 29515 we
proposed the current (CY 2011) work
RVU of 0.73. The AMA RUC
recommended maintaining the current
work RVUs for this service as well. For
CPT code 29515, the AMA RUC
recommended 7 minutes of pre-service
evaluation time and 5 minutes of postservice time. We proposed to reduce the
AMA RUC-recommended times to
5 minutes of pre-service evaluation time
and 3 minutes of post-service time for
CPT code 29515 (76 FR 32442).
Comment: In its public comments to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that CMS agreed
with the AMA RUC-recommended work
RVU, but noted that CMS disagreed
with the AMA RUC-recommended preservice and post-service time
components due to an E/M service
typically being provided on the same
day of service. Commenters
recommended that CMS accept the
AMA RUC-recommended pre-service
evaluation time of 7 minutes and
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immediate post-service time of
5 minutes for CPT code 29515.
Response: Based on the comments
received, we re-reviewed the pre- and
post-service time and work assigned to
this service. We continue to believe that
there is overlap in the pre- and postservice work between the E/M visit and
service described by CPT code 29126.
We believe that this overlap was
appropriately accounted for by
removing one-third of the pre-service
evaluation minutes, and one-third of the
post service minutes, thereby reducing
the pre-service evaluation time from
7 minutes to 5 minutes, and the postservice time from 5 minutes to
3 minutes. In sum, for CPT code 29515
for CY 2012, we are finalizing the FiveYear Review proposed and AMA RUCrecommended work RVU of 0.73, with
a pre-service evaluation time of
5 minutes, and a post-service time of
3 minutes. CMS time refinements can be
found in Table 16. In CPT code 29540
(Strapping; ankle and/or foot) was
identified by the Five-Year Review
Identification Workgroup through the
HarvardValued—Utilization > 100,000
screen. Upon review, the AMA RUC
recommended this family of services be
surveyed.
As detailed in the CY 2011 final rule
with comment period (75 FR 73331), for
CPT code 29540, we assigned an interim
final work RVU of 0.32. The HCPACrecommended a work RVU of 0.39. The
HCPAC compared the total time
required for CPT code 29540 to CPT
code 29580 (Strapping; Unna boot), 18
and 27 minutes, respectively, and noted
that CPT code 29540 requires less time,
mental effort/judgment, technical skill
and psychological stress than CPT code
29580. The HCPAC determined that
CPT code 29540 was approximately 30
percent less intense and complex than
CPT code 29580, resulting in work
RVUs of 0.39 for CPT code 29540 (75 FR
73331). We disagreed with the HCPACrecommended work RVU for this service
and believed work RVUs of 0.32 were
appropriate. We believed CPT code
11720 (Debridement of nail(s) by any
method(s); 1 to 5) (work RVUs = 0.32)
was a more appropriate crosswalk
(75 FR 73331).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
0.32 for CPT code 29540 and believe
that the HCPAC work RVU of 0.39 is
more appropriate for this service.
Additionally, commenters supported
HCPAC’s original recommendation of
0.39 for code 29540 because they
believe this code is more closely related
to reference code 29580 (work RVU =
0.55). Commenters disagreed with the
reference service put forward by CMS,
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and asserted that the HCPAC-chosen
reference service is a stronger
comparison code.
Response: Based on the comments
received, we referred CPT code 29540 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 0.39. As
a result of the refinement panel ratings
and clinical review by CMS, we are
assigning a work RVU of 0.39 to CPT
code 29540 as the final value for CY
2012.
As detailed in the CY 2011 final rule
with comment period (75 FR 73331), for
CPT code 29550 (Strapping; toes), we
assigned an interim final work RVU of
0.15. The HCPAC recommended a work
RVU of 0.25. The HCPAC compared this
service to CPT code 97762 (Checkout for
orthotic/prosthetic use, established
patient, each 15 minutes) (work RVU =
0.25), which it believed requires the
same intensity and complexity to
perform as CPT code 29550. The
HCPAC recommended crosswalking the
work RVUs for 29550 to reference CPT
code 97762. The HCPAC reviewed the
survey time and determined that
7 minutes pre-service, 5 minutes intraservice, and 1 minute immediate postservice time were appropriate to
perform this service. We disagreed with
the HCPAC-recommended value for this
service and believed a work RVU of
0.15, the survey low value, was
appropriate, with 5 minutes of pre- and
intra-service time and 1 minute of postservice time, as we believed the HCPACrecommended pre-service time of 7
minutes was excessive (75 FR 73331).
Comment: Commenters expressed
concerns noting that CMS has
recommended the interim value be set
equal to the survey low, which they
believe goes against the spirit of the
surveys and in fact may be based on the
response of an outlier, and without a
reference service to further support the
interim recommendation. Commenters
agreed with the HCPAC request, and
requested that CMS accept the HCPACrecommended work RVU of 0.25 and
7 minutes pre-service time, 5 minutes
intra-service time and 1 minute postservice time for CPT code 29550.
Response: Based on the comments
received, we referred CPT code 29550 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 0.25. As
a result of the refinement panel ratings
and clinical review by CMS, we are
assigning a work RVU of 0.25, with
5 minutes of pre- and intra-service time
and 1 minute of post-service time, to
CPT code 29550 as the final values for
CY 2012. For CY 2012, we received no
comments on the CY 2011 interim final
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work RVUs for CPT codes 29914, 29915,
and 29916. We believe these values
continue to be appropriate and are
finalizing them without modification
(Table 15).
(12) Respiratory: Lungs and Pleura (CPT
Codes 32405, 32851–32854, 33255)
We discussed CPT code 32851 (Lung
transplant, single; without
cardiopulmonary bypass) in the Fourth
Five-Year Review of Work (76 FR
32444). As noted in the proposed notice,
the AMA RUC reviewed the survey
responses and concluded that the
survey 25th percentile work RVU of
63.00 appropriately accounted for the
physician work required to perform this
service. We disagreed with the AMA
RUC-recommended work RVU for CPT
code 32851 and upon a clinical review
where we compared this service to other
services, we concluded that a work RVU
of 59.64 was more appropriate for this
service. Comparing CPT code 33255
(Operative tissue ablation and
reconstruction of atria, extensive (e.g.,
maze procedure); without
cardiopulmonary bypass) (work RVU =
29.04) with CPT code 33256 (Operative
tissue ablation and reconstruction of
atria, extensive (e.g., maze procedure);
with cardiopulmonary bypass) (work
RVU = 34.90), there is a difference in
work RVU of 5.86. We stated that we
believed this difference in work RVUs
reflects the additional time and
physician work performed while the
patient is on cardiopulmonary bypass.
In addition, we stated that we
believed this was the appropriate
interval in physician work
distinguishing CPT code 32852 (Lung
transplant, single; with
cardiopulmonary bypass), from CPT
code 32851 (Lung transplant, single;
without cardiopulmonary bypass). Since
we proposed a work RVU of 65.05 for
CPT code 32852 (see below), we
believed a work RVU of 59.64 accurately
reflects the work associated with CPT
code 32851 and maintains appropriate
relativity among similar services.
Therefore, we proposed an alternative
work RVU of 59.64 for CPT code 32851
for CY 2012.
For CPT code 32852 (Lung transplant,
single; with cardiopulmonary bypass),
the AMA RUC reviewed the survey
responses and concluded that the
survey 25th percentile work RVU was
too low and the median work RVU was
too high. Therefore, the AMA RUC
recommended a work RVU of 74.37 for
CPT code 32582. We disagreed with the
AMA RUC-recommended work RVU for
CPT code 32582 and believed that the
survey 25th percentile value of a work
RVU of 65.50 was more appropriate for
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this service. Therefore, we proposed an
alternative work RVU of 65.50 for CPT
code 32582 for CY 2012.
Comment: The commenters disagreed
with CMS’ rationale to use the survey
25th percentile work RVU for CPT code
32852 and then use a reverse building
block methodology to determine the
proposed work RVUs for CPT code
32851. The commenters asserted that
the AMA RUC considered and rejected
the 25th percentile survey result for CPT
code 32852, noting that the AMA RUC
believed that the survey 25th percentile
work RVU is insufficient to reflect the
physician work involved in furnishing
this service.
Response: Based on the comments
received, we referred CPT codes 32851
and 32852 to the CY 2011 multispecialty refinement panel for further
review. CPT code 32851 has a current
(CY 2011) work RVU of 41.61, in the
Five-Year Review we proposed a work
RVU of 59.64, and the AMA RUC
recommended a work RVU of 63.00. The
median refinement panel work RVU was
63.00. CPT code 32852 has a current
(CY 2011) work RVU of 45.48, in the
Five-Year Review we proposed a work
RVU of 65.50, and the AMA RUC
recommended a work RVU of 74.37. The
median refinement panel work RVU was
74.37. For CPT codes 32851 and 32852,
as well as the other CPT codes in this
family, the Five-Year Review proposed
work RVUs represent a significant
increase over the current (CY 2011)
work RVUs. We believe that the even
higher AMA RUC-recommended work
RVUs and refinement panel results
would create a new higher standard of
relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 59.64 for CPT code
32851 and 65.50 for CPT code 32852,
are more appropriate in order to
preserve appropriate relativity across
code families. Accordingly, we are
assigning a work RVU of 59.64 to CPT
code 32851 and 65.50 to CPT code
32852 as final values for CY 2012.
We discussed CPT code 32853 (Lung
transplant, double (bilateral sequential
or en bloc); without cardiopulmonary
bypass) in the Fourth Five-Year Review
of Work (76 FR 32444). As noted in the
proposed notice the AMA RUC
reviewed the survey responses and
concluded that the survey median work
RVU of 90.00 appropriately accounted
for the physician work required to
perform this service. We disagreed with
the AMA RUC-recommended work RVU
for CPT code 32853 and believed that
the survey 25th percentile value of
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84.48 was more appropriate for this
service as a reflection of the time and
intensity of the service in relation to
other major surgical procedures.
Therefore, we proposed an alternative
work RVU of 84.48 for CPT code 32853
for CY 2012.
For CPT code 32854 (Lung transplant,
double (bilateral sequential or en bloc);
with cardiopulmonary bypass), the
AMA RUC reviewed the survey
responses and concluded that the
survey median work RVU of 95.00
appropriately accounted for the
physician work required to perform this
service. We disagreed with the AMA
RUC-recommended work RVU for CPT
code 32854 and believed that the survey
25th percentile value of 90.00 was more
appropriate for this service. We stated
that a work RVU of 90.00 maintains the
relativity between CPT code 32851
(Lung transplant, single; without
cardiopulmonary bypass) and CPT code
32854, which describes a double lung
transplant. We believed this work RVU
reflects the increased intensity in total
service for CPT code 32584 when
compared to CPT code 32851.
Therefore, we proposed an alternative
work RVU of 90.00 for CPT code 32854
for CY 2012.
Comment: The commenters disagreed
with CMS’ rationale to use the survey
25th percentile values for CPT codes
32853 and 32584. The commenters
asserted that the AMA RUC
recommendations were based on a
careful and deliberate evaluation of the
work involved in the provision of
double lung transplantation, as
compared with the work involved in
other services.
Response: Based on the comments
received, we referred CPT codes 32853
and 32854 to the CY 2011 multispecialty refinement panel for further
review. CPT code 32853 has a current
(CY 2011) work RVU of 50.78, in the
Five-Year Review we proposed a work
RVU of 84.48, and the AMA RUC
recommended a work RVU of 90.00. The
median refinement panel work RVU was
85.00, slightly higher than the proposed
work RVU. CPT code 32854 has a
current (CY 2011) work RVU of 54.74,
in the Five-Year Review we proposed a
work RVU of 90.00, and the AMA RUC
recommended a work RVU of 95.00. The
median refinement panel work RVU was
95.00. For CPT codes 32853 and 32854,
as well as the other CPT codes in this
family, the Five-Year Review proposed
work RVUs represent a significant
increase over the current (CY 2011)
work RVUs. We believe that the even
higher AMA RUC-recommended work
RVUs and refinement panel results
would create a new higher standard of
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relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 84.48 to CPT code
32853 and 90.00 to CPT code 32854, are
more appropriate. Accordingly, we are
assigning a work RVU of 84.48 to CPT
code 32853 and 90.00 to CPT code
32854 as final values for CY 2012.
We note that CPT code 32405 (Biopsy,
Lung or mediastinum) was also
reviewed in this family for the Fourth
Five-Year Review. We agreed with the
AMA RUC’s methodology and
recommended value for this code.
Accordingly, we are finalizing a work
RVU of 1.93 for CPT code 32405. We
note the CY 2012 final values for the
codes in this family are summarized in
Table 15.
(13) Cardiovascular: Heart and
Pericardium (CPT Codes 33030–37766)
We discussed CPT code 33030
(Pericardiectomy, subtotal or complete;
without cardiopulmonary bypass) in the
Fourth Five-Year Review of Work (76
FR 32444) where we noted the AMA
RUC reviewed the survey responses and
concluded that the survey median work
RVUs of 39.50 for CPT code 33030
appropriately accounted for the work
required to perform this service.
We disagreed with the AMA RUCrecommended work RVUs for CPT code
33030. Following comparison with
similar codes, we believed that the
survey 25th percentile value of 36.00
was more appropriate for this service.
Therefore, we proposed an alternative
work RVUs of 36.00 for CPT code 33030
for CY 2012.
Comment: The commenters disagreed
with this proposed value and stated that
they preferred that CMS accept the
AMA RUC-recommended work RVUs of
39.50 based on the AMA RUC rationale.
The commenters believed this would
place the value of CPT code 33030
appropriately as far as time and
intensity of physician work in relation
to 33031.
Response: Based on the comments
received, we referred CPT code 33030 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33030 has current (CY 2011) work RVUs
of 22.29, in the Five-Year Review we
proposed work RVUs of 36.00, and the
AMA RUC recommended work RVUs of
39.50. The median refinement panel
work RVUs were 37.10, between the
proposed work RVUs and the AMA RUC
recommendation. For CPT code 33030,
as well as the other CPT codes in this
family, the Five-Year Review proposed
work RVUs represent a significant
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increase over the current (CY 2011)
work RVUs. We believe that the even
higher AMA RUC-recommended work
RVUs and refinement panel results
would create a new higher standard of
relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 36.00, which are the
survey 25th percentile work RVUs, are
more appropriate. Accordingly, we are
assigning work RVUs of 36.00 to CPT
code 33030 as the final value for CY
2012.
We discussed CPT code 33120
(Excision of intracardiac tumor,
resection with cardiopulmonary bypass)
in the Fourth Five-Year Review of Work
(76 FR 32444), where we noted the
AMA RUC reviewed the survey
responses and concluded that the 25th
percentile work RVUs for CPT code
33120 appropriately accounted for the
work required to furnish this service.
The AMA RUC recommended work
RVUs of 42.88 for CPT code 33120.
We disagreed with the AMA RUCrecommended work RVUs for CPT code
33120 and believed that work RVUs of
38.45 were more appropriate for this
service. We compared CPT code 33120
with CPT code 33677 (Closure of
multiple ventricular septal defects; with
removal of pulmonary artery band, with
or without gusset) (work RVUs = 38.45)
and found the codes to be similar in
complexity and intensity. We believed
that work RVUs of 38.45 accurately
reflect the work associated with CPT
code 33677 and properly maintains the
relativity of similar services. Therefore,
we proposed an alternative work RVUs
of 38.45 for CPT code 33120 for CY
2012.
Comment: The commenters noted that
CMS’ proposed value, based on a direct
crosswalk to 33677, (Closure of multiple
ventricular septal defects; with removal
of pulmonary artery band, with or
without gusset), was less than the 25th
percentile RUC-recommended value of
42.88. Commenters strongly disagreed
with the direct crosswalk and requested
that CMS review CPT code 33120 in
relation to the key reference code
selected by physicians who furnish the
procedure, CPT code 33426
(Valvuloplasty, mitral valve, with
cardiopulmonary bypass; with
prosthetic ring). The commenters stated
that this procedure is very similar to
operating to remove the typical left
atrial tumor, utilizing the same cardiac
incision and the same cannulation
strategy for cardiopulmonary bypass.
The commenters also noted that CPT
code 33426 is also an MPC list code and
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is furnished frequently by adult cardiac
surgeons who also perform CPT code
33120.
Response: Based on the comments
received, we referred CPT code 33120 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33120 has current (CY 2011) work RVUs
of 27.45, in the Five-Year Review we
proposed work RVUs of 38.45, and the
AMA RUC recommended work RVUs of
42.88. The median refinement panel
work RVUs were also 42.88. For CPT
code 33120, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe that a comparison of
CPT code 33120 with CPT code 33677
(Closure of multiple ventricular septal
defects; with removal of pulmonary
artery band, with or without gusset)
(work RVUs = 38.45) shows the codes to
be similar in complexity and intensity.
Therefore, we believe that work RVUs of
38.45 accurately reflect the work
associated with CPT code 33677 and
properly maintains the relativity of
similar services. Accordingly, we are
assigning work RVUs of 38.45 to CPT
code 33120 as the final value for CY
2012.
We discussed CPT code 33412
(Replacement, aortic valve; with
transventricular aortic annulus
enlargement (Konno procedure)) in the
Fourth Five-Year Review of Work (76
FR 32444) where we noted the AMA
RUC reviewed the survey responses and
concluded that the survey median work
RVUs for CPT code 33412 appropriately
accounted for the work required to
furnish this service. The AMA RUC
recommended work RVUs of 60.00 for
CPT code 33412. We disagreed with the
AMA RUC-recommended work RVUs
for CPT code 33412 and believed that
the survey 25th percentile value of
59.00 was more appropriate for this
service. Therefore, we proposed
alternative work RVUs of 59.00 for CPT
code 33412 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed value and asserted
that the AMA RUC workgroup closely
reviewed this service and compared it to
key reference service CPT code 33782
(Aortic root translocation with
ventricular septal defect and pulmonary
stenosis repair (i.e., Nikaidoh
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procedure); without coronary ostium
reimplantation) (work RVUs = 60.08 and
intra-time = 300 minutes). The
commenters believed that these two
services require the same intensity and
complexity, physician work and time to
furnish.
Response: Based on the comments
received, we referred CPT code 33412 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33412 has current (CY 2011) work RVUs
of 43.94, in the Five-Year Review we
proposed work RVUs of 59.00, and the
AMA RUC recommended work RVUs of
60.00. The median refinement panel
work RVUs were 59.00, which were also
the proposed work RVUs. For CPT code
33412, as well as the other CPT codes
in this family, the Five-Year Review
proposed work RVUs represent a
significant increase over the current (CY
2011) work RVUs. We believe that the
even higher AMA RUC-recommended
work RVUs would create a new higher
standard of relativity for codes within
this family that would not be
appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
59.00, which are consistent with the
refinement panel median RVUs, are
more appropriate. Accordingly, we are
assigning work RVUs of 59.00 to CPT
code 33412 as the final value for CY
2012.
We discussed CPT code 33468
(Tricuspid valve repositioning and
plication for Ebstein anomaly) in the
Fourth Five-Year Review of Work (76
FR 32444) where we noted the AMA
RUC reviewed the survey responses and
concluded that the survey median work
RVUs for CPT code 33468 appropriately
accounted for the work required to
furnish this service. The AMA RUC
recommended work RVUs of 50.00 for
CPT code 33468. We disagreed with the
AMA RUC-recommended work RVUs
for CPT code 33468 and believed that
the survey 25th percentile value of
45.13 was more appropriate for this
service. Therefore, we proposed
alternative work RVUs of 45.13 for CPT
code 33468 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed value and stated
that the AMA RUC workgroup closely
reviewed this service and compared
CPT code 33468 to key reference service
CPT code 33427, (Valvuloplasty, mitral
valve, with cardiopulmonary bypass;
radical reconstruction, with or without
ring) (work RVUs = 44.83 and intra-time
= 221 minutes). The commenters
asserted that CPT code 33468 is more
intense and complex, and requires more
physician work and time to perform
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than the key reference service CPT code
33427.
Response: Based on the comments
received, we referred CPT code 33468 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33468 has current (CY 2011) work RVUs
of 32.94, in the Five-Year Review we
proposed work RVUs of 45.13, and the
AMA RUC recommended work RVUs of
50.00. The median refinement panel
work RVUs were 46.00. For CPT code
33468, as well as the other CPT codes
in this family, the Five-Year Review
proposed work RVUs represent a
significant increase over the current (CY
2011) work RVUs. We believe that the
even higher AMA RUC-recommended
work RVUs and refinement panel results
would create a new higher standard of
relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 45.13, which are the
survey 25th percentile work RVUs, are
more appropriate. Accordingly, we are
assigning work RVUs of 45.13 to CPT
code 33468 as the final value for CY
2012.
We discussed CPT code 33645 (Direct
or patch closure, sinus venosus, with or
without anomalous pulmonary venous
drainage) in the Fourth Five-Year
Review of Work (76 FR 32445) where
we noted the AMA RUC reviewed
survey responses and concluded that
the survey median work RVUs for CPT
code 33645 appropriately accounts for
the work required to perform this
service. The AMA RUC recommended
work RVUs of 33.00 for CPT code
33645. We disagreed with the AMA
RUC-recommended work RVUs for CPT
code 33645 and believed that the survey
25th percentile value of 31.30
appropriately captures the total work for
the service. Therefore, we proposed
alternative work RVUs of 31.30 for CPT
code 33645 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed value and stated
that the AMA RUC workgroup closely
reviewed this service and compared
33645 to key reference service CPT
codes 33641, (Repair atrial septal defect,
secundum, with cardiopulmonary
bypass, with or without patch) (work
RVUs = 29.58 and intra-time = 164
minutes) and 33681, (Closure of single
ventricular septal defect, with or
without patch) (work RVUs = 32.34 and
intra-time = 150 minutes). The
commenters asserted that 33645,
(Surveyed intra-service time = 175
minutes) requires more intensity and
complexity to furnish compared to these
reference services.
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Response: Based on the comments
received, we referred CPT code 33645 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33645 has current (CY 2011) work RVUs
of 28.10, in the Five-Year Review we
proposed work RVUs of 31.30, and the
AMA RUC recommended work RVUs of
33.00. The median refinement panel
work RVUs were 31.50, slightly higher
than the proposed work RVUs. For CPT
code 33645, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
31.30, which are the survey 25th
percentile work RVUs, are more
appropriate. Accordingly, we are
assigning work RVUs of 31.30 to CPT
code 33645 as the final value for CY
2012.
We discussed CPT code 33647 (Repair
of atrial septal defect and ventricular
septal defect, with direct or patch
closure) in the Fourth Five-Year Review
of Work (76 FR 32445) where we noted
the AMA RUC reviewed survey
responses and concluded that the
survey median work RVUs for CPT code
33467 appropriately account for the
work required to furnish this service.
The AMA RUC recommended work
RVUs of 35.00 for CPT code 33647. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
33647 and believed that the survey 25th
percentile value of 33.00 was more
appropriate for this service. Therefore,
we proposed alternative work RVUs of
33.00 for CPT code 33647 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed value and stated
that the AMA RUC workgroup closely
reviewed this service and compared
CPT code 33647 to key reference service
CPT code 33681, (Closure of single
ventricular septal defect, with or
without patch) (work RVUs = 32.34 and
intra-time = 150 minutes). The
commenters asserted that CPT code
33647 are similarly intense and
complex, and requires more physician
work and time to furnish compared to
the key reference service.
Response: Based on the comments
received, we referred CPT code 33647 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33647 has current (CY 2011) work RVUs
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73127
of 29.53, in the Five-Year Review we
proposed work RVUs of 33.00, and the
AMA RUC recommended work RVUs of
35.00. The median refinement panel
work RVUs were 33.00, the same as the
proposed work RVUs. For CPT code
33647, as well as the other CPT codes
in this family, the Five-Year Review
proposed work RVUs represent a
significant increase over the current (CY
2011) work RVUs. We believe that the
even higher AMA RUC-recommended
work RVUs create a new higher
standard of relativity for codes within
this family that would not be
appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
33.00, which are consistent with the
refinement panel median work RVUs,
are more appropriate. Accordingly, we
are assigning work RVUs of 33.00 to
CPT code 33647 as the final value for
CY 2012.
Fourth Five-Year Review of Work (76
FR 32445) where we noted the AMA
RUC reviewed survey responses, and
recommended the survey median work
RVUs of 38.75 for CPT code 33692. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
33692 and believed that the survey 25th
percentile value of 36.15 was more
appropriate for this service. Therefore,
we proposed alternative work RVUs of
36.15 for CPT code 33692 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed value and stated
that the AMA RUC workgroup closely
reviewed this service and compared the
service to key reference service CPT
code 33684, (Closure of single
ventricular septal defect, with or
without patch; with pulmonary
valvotomy or infundibular resection
(acyanotic)) (work RVUs = 34.37 and
intra-time = 200 minutes). Commenters
asserted that CPT code 33692 is
similarly intense and complex, and
requires more physician work and time
to furnish than the key reference
service.
Response: Based on the comments
received, we referred CPT code 33692 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33692 has current (CY 2011) work RVUs
of 31.54, in the Five-Year Review we
proposed work RVUs of 36.15, and the
AMA RUC recommended work RVUs of
38.75. The median refinement panel
work RVUs were 38.75. For CPT code
33692, as well as the other CPT codes
in this family, the Five-Year Review
proposed work RVUs represent a
significant increase over the current (CY
2011) work RVUs. We believe that the
even higher AMA RUC-recommended
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work RVUs and refinement panel results
would create a new higher standard of
relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 36.15, which are the
survey 25th percentile work RVUs, are
more appropriate. Accordingly, we are
assigning work RVUs of 36.15 to CPT
code 33692 as the final value for CY
2012.
We recommended work RVUs of
43.00 for CPT code 33710, the survey
median work RVUs. We disagreed with
the AMA RUC-recommended work
RVUs for CPT code 33710 and believed
that the survey 25th percentile value of
37.50 was more appropriate for this
service. We believed the physician time
and intensity for CPT code 33710
reflected the appropriate incremental
adjustment when compared to the key
reference service, CPT code 33405
(Replacement, aortic valve, with
cardiopulmonary bypass; with
prosthetic valve other than homograft or
stentless valve) (work RVUs = 41.32 and
intra-service time = 198 minutes).
Therefore, we proposed alternative work
RVUs of 37.50 for CPT code 33710 for
CY 2012.
Commenters disagreed with CMS’
proposed value and stated that the AMA
RUC workgroup closely reviewed this
service and compared 33710 to key
reference service CPT code 33405. The
commenters asserted that 33710 is
similarly intense and complex, and
requires more physician work and time
to furnish than the key reference
service.
Response: Based on the comments
received, we referred CPT code 33710 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33710 has current (CY 2011) work RVUs
of 30.41, in the Five-Year Review we
proposed work RVUs of 37.50, and the
AMA RUC recommended work RVUs of
43.00. The median refinement panel
work RVUs were also 43.00. For CPT
code 33710, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
37.50, which are the survey 25th
percentile work RVUs, and more
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comparable to the reference service, are
more appropriate. Accordingly, we are
assigning work RVUs of 37.50 to CPT
code 33710 as the final value for CY
2012.
We discussed CPT code 33875
(Descending thoracic aorta graft, with or
without bypass) in the Fourth Five-Year
Review of Work (76 FR 32445) and
noted that the AMA RUC reviewed
survey responses and concluded that
the 25th percentile work RVUs for code
33875 appropriately account for the
work required to furnish this service.
The AMA RUC recommended work
RVUs of 56.83 for CPT code 33875. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
33875 and believed that work RVUs of
50.72 were more appropriate for this
service. We compared CPT code 33875
with CPT code 33465 (Replacement,
tricuspid valve, with cardiopulmonary
bypass) (work RVUs = 50.72) and
believed that CPT code 33875 was
similar to CPT code 33465, with similar
inpatient and outpatient work. We
believed these work RVUs corresponded
better to the value of the service than
the survey 25th percentile work RVUs.
Therefore, we proposed alternative work
RVUs of 50.72 for CPT code 33875 for
CY 2012.
Comment: Commenters disagreed
with CMS’ proposed direct crosswalk to
CPT code 33465, and stated that
patients and procedures are
substantially different for CPT 33875.
The commenters requested that CMS
reconsider its proposed work value of
50.72 and, instead, accept the AMA
RUC-recommended values of 56.83,
which are the 25th percentile of the
physician survey.
Response: Based on the comments
received, we referred CPT code 33875 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33875 has current (CY 2011) work RVUs
of 35.78, in the Five-Year Review we
proposed work RVUs of 50.72, and the
AMA RUC recommended work RVUs of
56.83. The median refinement panel
work RVUs were also 56.83. For CPT
code 33875, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
compared CPT code 33875 with CPT
code 33465 and believed that CPT code
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33875 is similar to CPT code 33465,
with similar inpatient and outpatient
work. We continue to believe these
work RVUs corresponds better to the
value of the service than the survey 25th
percentile work RVUs. Accordingly, we
are assigning work RVUs of 50.72 to
CPT code 33875 as the final value for
CY 2012.
We discussed CPT code 33910
(Pulmonary artery embolectomy; with
cardiopulmonary bypass) in the Fourth
Five-Year Review of Work (76 FR
32445) and noted that after reviewing
the service, the AMA RUC
recommended work RVUs of 52.33 for
CPT code 33910. We disagreed with the
AMA RUC-recommended work RVUs
for CPT code 33910 and believed that
work RVUs of 48.21 were more
appropriate for this service. We
compared CPT code 33910 with CPT
code 33542 (Myocardial resection (e.g.,
ventricular aneurysmectomy)) (work
RVUs = 48.21). We recognized that CPT
code 33542 is not an emergency service.
Nevertheless, this procedure requires
cardiopulmonary bypass and has
physician time and visits that are
consistently necessary for the care
required for the patient that are similar
to CPT code 33910. We believed that
work RVUs of 48.21 accurately reflected
the work associated with CPT code
33910 and properly maintained the
relativity for a similar service.
Therefore, we proposed alternative work
RVUs of 48.21 for CPT code 33910 for
CY 2012.
Comment: Commenters requested that
CMS reconsider the proposed work
value of 48.21, and accept the AMA
RUC-recommended work value of 52.33,
the survey median value. Commenters
disagreed with the CMS-proposed direct
crosswalk to the value of CPT code
33542. Commenters asserted that,
although some of the technical
composition of the two codes (time and
visits) is similar, the intensity and
complexity measures are different and
easily account for the additional RVUs
of 4.12 that would result from utilizing
the survey median work value.
Response: Based on the comments
received, we referred CPT code 33910 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33910 has current (CY 2011) work RVUs
of 29.71, in the Five-Year Review we
proposed work RVUs of 48.21, and the
AMA RUC recommended work RVUs of
52.33. The median refinement panel
work RVUs were 52.33. For CPT code
33910, as well as the other CPT codes
in this family, the Five-Year Review
proposed work RVUs represent a
significant increase over the current (CY
2011) work RVUs. We believe that the
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even higher AMA RUC-recommended
work RVUs and refinement panel results
would create a new higher standard of
relativity for codes within this family
that would not be appropriate when
compared to other codes with similar
physician time and intensity in different
code families. We continue to believe
the work RVUs of 48.21, which are the
survey 25th percentile work RVUs and
properly maintain the relativity with
CPT code 33542 are more appropriate.
Accordingly, we are assigning work
RVUs of 48.21 to CPT code 33910 as the
final value for CY 2012.
Fourth Five-Year Review of Work (76
FR 32445) and noted that the AMA RUC
reviewed survey responses and
recommended work RVUs of 100.00, the
survey median work RVUs, for CPT
code 33935. We disagreed with the
AMA RUC-recommended work RVUs
for CPT code 33935 and believed that
the survey 25th percentile value of
91.78 was more appropriate for this
service. We believed this service is more
intense and complex than the reference
CPT code 33945 (Heart transplant, with
or without recipient cardiectomy) (work
RVU = 89.50) and that the survey 25th
percentile work RVUs accurately
reflected the increased intensity and
complexity when compared to the
reference CPT code 33945. Therefore,
we proposed alternative work RVUs of
91.78 for CPT code 33935 for CY 2012.
Comment: Commenters requested that
CMS reconsider its proposed work
RVUs of 91.78 and accept the RUCrecommended survey median work
RVUs of 100.00 for CPT code 33935.
Commenters noted that CMS
acknowledged the increased intensity,
complexity, and physician work
compared to the key reference service
CPT code 33945 Heart Transplant.
However, commenters asserted that CPT
code 33935 has substantially higher
intensity and complexity than CPT code
33945, and CMS did not adequately
account for the additional physician
work.
Response: Based on the comments
received, we referred CPT code 33935 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
33935 has current (CY 2011) work RVUs
of 62.01, in the Five-Year Review we
proposed work RVUs of 91.78, and the
AMA RUC recommended work RVUs of
100.00. The median refinement panel
work RVUs were also 100.00. For CPT
code 33935, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
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refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe work RVUs of 91.78,
which are the survey 25th percentile
work RVUs, are more appropriate.
Accordingly, we are assigning work
RVUs of 91.78 to CPT code 33935 as the
final value for CY 2012.
We discussed CPT code 33980
(Removal of ventricular assist device,
implantable intracorporeal, single
ventricle) in the Fourth Five-Year
Review of Work (76 FR 32445). We
noted the AMA RUC reviewed the
survey results and recommended the
survey median work RVUs of 40.00.
Additionally, the AMA RUC
recommended a global period change
from 090 (Major surgery with a 1-day
pre-operative period and a 90-day
postoperative period included in the fee
schedule amount) to XXX (the global
concept does not apply to the code). We
agreed with the AMA RUCrecommended global period change
from 090 to XXX. However, we
disagreed with the AMA RUCrecommended work RVUs for CPT code
33980. We believed the work RVUs of
33.50 were more appropriate, given the
significant reduction in physician times
and decrease in the number and level of
post-operative visits that the AMA RUC
included in the value of CPT code
33980. For CY 2012, we proposed
alternative work RVUs of 33.50, the
survey 25th percentile work RVUs.
Comment: Commenters disagreed
with the proposed work RVUs, and
asserted that CPT code 33980 was
surveyed as an XXX code with no postoperative visits. Commenters stated that
CPT code 33980 is one of the most
intense, complex, and demanding
procedures that their specialty
furnishes. The commenters noted that
this is an obligatory reoperation, which
is almost always furnished during a onesix month time frame when the
adhesions are new, tenacious, and very
vascular. The commenters asserted that
the reoperation CPT code 33530
(Reoperation, coronary artery bypass
procedure or valve procedure, more
than 1 month after original operation
(List separately in addition to code for
primary procedure)) its value (work
RVUs = 10.13) should be considered.
Commenters noted, however, that
because CPT code 33530 is a ZZZ code
(code is related to another service and
is included in the global period of the
other service) its value would not apply
here. Secondly, the commenters noted
this procedure requires reconstruction
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of the large bore defect in the apex of
the left ventricle, which is technically
demanding, particularly in patients
destined for survival with a fragile and
compromised left ventricle that must
now support the circulation without
VAD support. The commenters believed
these features justify the higher AMA
RUC-recommended RVUs of 40.00.
Response: Based on the comments
received, we referred CPT code 33980 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVUs of 40.00,
which were consistent with the AMA
RUC recommendation. We believe work
RVUs of 33.50, which are the survey
25th percentile work RVU are more
appropriate, given the significant
reduction in physician times and
decrease in the number and level of
post-operative visits that the AMA RUC
included in the value of CPT code
33980. Accordingly, we are assigning
work RVUs of 33.50 to CPT code 33980
as the final value for CY 2012.
We discussed CPT code 35188
(Repair, acquired or traumatic
arteriovenous fistula; head and neck) in
the Fourth Five-Year Review of Work
(76 FR 32446) and noted the AMA RUC
reviewed the survey results and
recommended the survey median work
RVUs of 18.50 for CPT code 35188. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
35188 and proposed alternative work
RVUs of 18.00, which are the survey
25th percentile work RVUs. We believed
the work RVUs of 18.00 are more
appropriate, given the decrease in the
number and level of post-operative
visits that the AMA RUC included in
the value of CPT code 35188.
Comment: Commenters noted the
AMA RUC compared the service to key
reference CPT code 35011 (Direct repair
of aneurysm, pseudoaneurysm, or
excision (partial or total) and graft
insertion, with or without patch graft;
for aneurysm and associated occlusive
disease, axillary-brachial artery, by arm
incision) (work RVUs = 18.58) and
agreed they were similar services in the
sense that they are both vascular
operations on similar sized vessels in
the upper body. The AMA RUC also
compared 35188 to MPC codes 19318
Reduction mammoplasty (work RVUs =
16.03) and 44140 Colectomy, partial;
with anastomosis (work RVUs = 22.59),
which are similarly intensive surgical
procedures requiring technical skill to
successfully complete the operation.
Commenters asserted the differences
between CPT codes 35188, 19318, and
44140 lie in the post-operative work,
which are quite different, yet in proper
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rank order, and requested that CMS
reconsider this issue.
Response: Based on the comments
received, we referred CPT code 35188 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
35188 has current (CY 2011) work RVUs
of 15.16, in the Five-Year Review we
proposed work RVUs of 18.00, and the
AMA RUC recommended work RVUs of
18.50. The median refinement panel
work RVUs were also 18.50. For CPT
code 35188, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
18.00, which are the survey 25th
percentile work RVUs, are more
appropriate, given the decrease in the
number and level of post-operative
visits that the AMA RUC included in
the value of CPT code 35188.
Accordingly, we are assigning work
RVUs of 18.00 to CPT code 35188 as the
final value for CY 2012.
We discussed CPT code 35612
(Bypass graft, with other than vein;
subclavian) in the Fourth Five-Year
Review of Work (76 FR 32446) and
noted the AMA RUC reviewed the
survey results and recommended work
RVUs of 22.00 for CPT code 35612. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
35612 and proposed alternative work
RVUs of 20.35, which were the survey
25th percentile work RVUs. We believed
the work RVUs of 20.35 were more
appropriate, given the decrease in the
number and level of post-operative
visits that the AMA RUC included in
the value of CPT code 35612.
Comment: Commenters disagreed
with the proposed RVUs for CPT code
35612. Commenters noted that the AMA
RUC compared the service to key
reference CPT code 35661 (Bypass graft,
with other than vein; femoral-femoral)
(work RVUs = 20.35) and agreed the
work value for CPT code 35612 should
be higher than for the work value for
CPT code 35661. The AMA RUC also
compared the surveyed code to MPC
codes 22595 (Arthrodesis, posterior
technique, atlas-axis (C1–C2)) (work
RVUs = 20.46) and 62165
(Neuroendoscopy, intracranial; with
excision of pituitary tumor, transnasal
or trans-sphenoidal approach) (work
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RVUs = 23.23), which have similar work
intensities. Commenters requested that
CMS accept the AMA RUCrecommended work RVUs of 22.00 for
CPT code 35612.
Response: Based on the comments
received, we referred CPT code 35612 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
35612 has current (CY 2011) work RVUs
of 16.82, in the Five-Year Review we
proposed work RVUs of 20.35, and the
AMA RUC recommended work RVUs of
22.00. The median refinement panel
work RVUs were also 22.00. For CPT
code 35612, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
20.35, which are the survey 25th
percentile work RVUs, are more
appropriate, given the decrease in the
number and level of post-operative
visits that the AMA RUC included in
the value of CPT code 35612.
Accordingly, we are assigning work
RVUs of 20.35 to CPT code 35612 as the
final value for CY 2012.
We discussed CPT code 35800
(Exploration for postoperative
hemorrhage, thrombosis or infection;
neck) in the Fourth Five-Year Review of
Work (76 FR 32446) and noted the AMA
RUC used magnitude estimation to
recommend work RVUs for CPT code
35800 between the survey 25th
percentile (12.00 RVUs) and median
(15.00 RVUs) work value. Accordingly,
the AMA RUC recommended work
RVUs of 13.89 for CPT code 35800. We
disagreed with the AMA RUCrecommended work RVUs for CPT code
35800 and proposed alternative work
RVUs of 12.00, which were the survey
25th percentile work RVUs. We believed
the work RVU of 12.00 were more
appropriate, given that two of the key
reference codes to which this service
has been compared have identical intraservice time (60 minutes), but
significantly lower work RVUs.
Comment: Commenters noted that the
AMA RUC compared the service to key
reference codes. Commenters agreed
with the intensity, physician work, and
proper rank order amongst the
comparison codes achieved when CPT
code 35800 was valued between the
survey 25th percentile (12.00 RVUs) and
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median work value (15.00 RVUs) with
work RVUs of 13.89. Commenters
believed it was inappropriate for CMS to
reduce the value of CPT code 35800
based on a comparison to two services
with much less total time. Commenters
requested that CMS accept the AMA
RUC-recommended work RVUs of
13.89.
Response: Based on the comments
received, we referred CPT code 35800 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
35800 has current (CY 2011) work RVUs
of 8.07, in the Five-Year Review we
proposed work RVUs of 12.00, and the
AMA RUC recommended work RVUs of
13.89. The median refinement panel
work RVU were also 13.89. For CPT
code 35800, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be an appropriate when compared to
other codes with similar physician time
and intensity in different code families.
That is, as when considering the values
for the two reference services previously
discussed, comparing CPT code 35800
to codes outside of the code family but
with identical intra-service time (60
minutes) demonstrates that in order to
maintain inter-family relativity in the
PFS, the 25th percentile survey work
RVUs of 12.00 are more appropriate
than the higher work RVUs
recommended by the AMA RUC and the
refinement panel. Accordingly, we are
assigning work RVUs of 12.00 to CPT
code 35800 as the final value for CY
2012.
We discussed CPT code 35840
(Exploration for postoperative
hemorrhage, thrombosis or infection;
abdomen) in the Fourth Five-Year
Review of Work (76 FR 32446) and
noted the AMA RUC used magnitude
estimation to recommend work RVUs
for CPT code 35840 between the survey
25th percentile (19.25 RVU) and survey
median (22.30 RVUs) work value.
Accordingly, the AMA RUC
recommended a work RVU of 21.19 for
CPT code 35840. We disagreed with the
AMA RUC-recommended work RVU for
CPT code 35840 and proposed
alternative work RVUs of 20.75, which
were between the survey 25th percentile
and survey median work RVUs. We
believed the work RVUs of 20.75 were
more appropriate given the comparison
to the two reference codes.
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Comment: Commenters disagreed
with the proposed work RVUs for CPT
code 35840. Commenters noted that the
AMA RUC compared CPT code 35840 to
the following two services: CPT code
49002 (Reopening of recent laparotomy)
(work RVUs = 17.63, 75 minutes intraservice time), and CPT code 37617
(Ligation, major artery (e.g., posttraumatic, rupture); abdomen) (work
RVUs = 23.70, 120 minutes intraservice
time). Commenters agreed with the
intensity, physician work, and proper
rank order amongst the comparison
codes when code 35840 was valued
between the survey 25th percentile
(19.25 RVUs) and median work value
(22.30 RVUs). Commenters requested
that CMS accept the AMA RUCrecommended work RVUs of 21.19.
Response: Based on the comments
received, we referred CPT code 35840 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
35840 has current (CY 2011) work RVUs
of 10.96, in the Five-Year Review we
proposed work RVUs of 20.75, and the
AMA RUC recommended work RVUs of
21.19. The median refinement panel
work RVUs were also 21.19. For CPT
code 33840, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be an appropriate when compared to
other codes with similar physician time
and intensity in different code families.
We continue to believe the work RVUs
of 20.75 are more appropriate given the
two reference codes to which this
service has been compared.
Accordingly, we are assigning work
RVUs of 20.75 to CPT code 35840 as the
final value for CY 2012.
We discussed CPT code 35860
(Exploration for postoperative
hemorrhage, thrombosis or infection;
extremity) in the Fourth Five-Year
Review of Work (76 FR 32446–32447)
and noted the AMA RUC used
magnitude estimation to recommend
work RVUs between the survey 25th
percentile (15.25 RVUs) and median
work value (18.00 RVUs). The AMA
RUC recommended work RVUs of 16.89
for CPT code 35860. We disagreed with
the AMA RUC-recommended work
RVUs for CPT code 35860 and proposed
alternative work RVUs of 15.25, which
were the survey 25th percentile work
RVUs. We believed these work RVU
maintained appropriate relativity within
the family of related services for the
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exploration of postoperative
hemorrhage.
Comment: Commenters disagreed
with CMS’ proposed RVUs of 15.25 for
CPT code 35860. Commenters stated the
complexity and intensity of this service
is higher because it is typically
furnished to elderly patients for whom
reoperation imposes more risks.
Commenters asserted that the family of
services was undervalued in the
Harvard study. Commenters disagreed
with CMS’s assertion that the proposed
work value is more relative to similar
services in comparison to the RUC
recommendation. During its review, the
AMA RUC compared CPT code 35860 to
two similar services: CPT code 34203
(Embolectomy or thrombectomy,
popliteal-tibioperoneal artery, by leg
incision) (work RVU = 17.86, 108
minutes intra-service time) and CPT
code 44602 (Suture of small intestine for
perforation) (work RVU = 24.72, 90
minutes intra-service time).
Commenters agreed with the intensity,
physician work, and proper rank order
amongst the comparison codes achieved
when CPT code 35860 is valued
between the survey 25th percentile
(15.25 RVUs) and median work value
(18.00 RVUs), at 16.89 work RVUs.
Commenters requested that CMS accept
the RUC recommended work RVUs of
16.89 for CPT code 35860.
Response: Based on the comments
received, we referred CPT code 35860 to
the CY 2011 multi-specialty refinement
panel for further review. CPT code
35860 has current (CY 2011) work RVUs
of 6.80, in the Five-Year Review we
proposed work RVUs of 15.25, and the
AMA RUC recommended work RVUs of
16.89. The median refinement panel
work RVUs were also 16.89. For CPT
code 35860, as well as the other CPT
codes in this family, the Five-Year
Review proposed work RVUs represent
a significant increase over the current
(CY 2011) work RVUs. We believe that
the even higher AMA RUCrecommended work RVUs and
refinement panel results would create a
new higher standard of relativity for
codes within this family that would not
be appropriate when compared to other
codes with similar physician time and
intensity in different code families. We
continue to believe the work RVUs of
15.25, which are the survey 25th
percentile work RVUs, maintain
appropriate relativity. Accordingly, we
are assigning work RVUs of 15.25 to
CPT code 35860 as the final value for
CY 2012.
As detailed in the Fourth Five-Year
Review, for CPT code 36600 (Arterial
puncture, withdrawal of blood for
diagnosis) we believed that the current
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73131
(CY 2011) work RVUs continued to
accurately reflect the work of these
services and, therefore, proposed work
RVUs of 0.32 for CPT code 36600. The
AMA RUC also recommended
maintaining the current (CY 2011) work
RVUs for these services. For CPT code
36600, the AMA RUC recommended a
pre-service evaluation time of 5 minutes
and immediate post service time of 5
minutes. We proposed a pre-service
evaluation time for CPT code 36600 of
3 minutes and a post service time of 3
minutes (76 FR 32447).
Comment: In its public comments to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that CMS agreed
with the AMA RUC-recommended work
RVU, but noted that CMS disagreed
with the AMA RUC-recommended preservice and post-service time
components due to an E/M service
typically being provided on the same
day of service. The AMA RUC
recommends that CMS accept the AMA
RUC-recommended pre-service
evaluation time of 5 minutes and
immediate post-service time of 5
minutes for CPT code 36600.
Response: In response to comments,
we re-reviewed CPT code 36600. After
reviewing the descriptions of preservice work and the recommended preservice time packages, we disagree with
the times recommended by the AMA
RUC. For CPT code 36600 we are
finalizing a work RVU of 0.32 and a preservice evaluation time of 3 minutes. In
addition, we are finalizing an intraservice time of 10 minutes, and a postservice time of 3 minutes for CPT code
36600. CMS time refinements can be
found in Table 16.
We discussed CPT code 36247
(Selective catheter placement, arterial
system; initial third order or more
selective abdominal, pelvic, or lower
extremity artery branch, within a
vascular family) in the Fourth Five-Year
Review of Work (76 FR 32445) and
proposed a CY 2012 work RVU of 6.29
and a global period change from 90-days
(Major surgery with a 1-day preoperative period and a 90-day
postoperative period included in the fee
schedule amount) to XXX (the global
concept does not apply to the code). The
AMA RUC recommended the survey
median work RVU of 7.00 for this
service. We disagreed with the RUCrecommended value noting that a
reduced global period would support a
reduction in the RVUs.
Comment: Commenters noted that the
dominant specialty for CPT code 36247
has changed since the original Harvard
valuations that therefore physician
practice also has changed. Commenters
pointed out that CMS’ discussion of the
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global period was not correct, that the
specialty societies had surveyed the
code based on a change to the global
period of 000 (endoscopic or minor
procedure with related preoperative and
post-operative relative values on the day
of the procedure only included in the
fee schedule payment amount;
evaluation and management services on
the day of the procedure generally not
payable) from the current global period
indicator of XXX. Commenters also
asserted that there had been a change in
the physician work for CPT code 36247
due to patient population changes and
the inclusion of moderate sedation as
inherent in the procedure. Finally,
commenters argued that the creation of
the lower extremity revascularization
codes in CY 2011 PFS final rule with
comment period (75 FR 73334)
increased the complexity of procedures
described by CPT code 36247.
Commenters requested that CMS
reconsider the proposed value and
global period.
Response: Based on the comments
received, we referred CPT code 36247 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median value was a work RVU of
7.0, the AMA RUC-recommended value.
Upon clinical review, we believe that
our proposed value of 6.29 in more
appropriate. We observe a significant
decrease in the physician times reported
for this service that argue for a lower
value, notwithstanding that the survey
was conducted for a 0-day global period,
which includes an evaluation and
management service on the same day.
We agree with commenters that our
discussion of the global period in the
Fourth Five-Year review of work was
inconsistent with the commenters’
original request. Therefore, we are
assigning the work RVU of 6.29 and a
global period of 000 to CPT code
37247on an interim basis for CY 2012
and invite additional public comment
on this code.
We discussed CPT code 36819
(Arteriovenous anastomosis, open; by
upper arm basilic vein transposition) in
the Fourth Five-Year Review of Work
(76 FR 32447) where we noted this code
was identified as a code with a site-ofservice anomaly. Medicare PFS claims
data indicated that this code is typically
furnished in an outpatient setting.
However, the current and AMA RUCrecommended values for this code
reflected work that is typically
associated with an inpatient service. As
discussed in section III.A. of this final
rule with comment period, our policy is
to remove any post-procedure inpatient
and subsequent observation care visits
remaining in the values for these codes
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and adjust physician times accordingly.
It is also our policy for codes with siteof-service anomalies to consistently
include the value of half of a discharge
day management service. While the
AMA RUC recommended maintaining
the current (CY 2011) work RVU of
14.47, utilizing our methodology, we
proposed an alternative work RVU for
CY 2012 of 13.29 with refinements in
time for CPT code 36819.
Comment: Commenters disagreed
with the CMS-proposed work RVU and
requested that CMS accept the AMA
RUC-recommended work RVU of 14.47
for 36819. Furthermore, commenters
asked that the AMA RUC-recommended
physician time should also be restored.
Commenters disagreed with CMS’ use of
the reverse building block methodology.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Commenters noted that the AMA RUC
reviewed the survey data, compared this
service to other services, and concluded
that there was no was no compelling
evidence to suggest a change in the
current work RVUs was warranted.
Response: Based on comments
received, we referred CPT code 36819 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 14.47,
which was consistent with the AMA
RUC recommendation to maintain the
current (CY 2011) work value. The
current (CY 2011) work RVU for this
service was developed when this service
was typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a final
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work RVU of 13.29 with refinements in
time for CPT code 36819 for CY 2012.
We discussed CPT code 36825
(Creation of arteriovenous fistula by
other than direct arteriovenous
anastomosis (separate procedure);
autogenous graft) in the Fourth FiveYear Review of Work (76 FR 32445 and
32446) where we noted this code was
identified as a code with a site-ofservice anomaly. Medicare PFS claims
data indicated that this code is typically
furnished in an outpatient setting.
However, the current and AMA RUCrecommended values for this code
reflected work that is typically
associated with an inpatient service. As
discussed in section III.A. of this final
rule with comment period, consistent
with that methodology, we removed the
subsequent observation care service,
reduced the discharge day management
service by one-half, and adjusted times
for CPT code 36825. While the AMA
RUC recommended maintaining the
current (CY 2011) work RVU of 15.13,
utilizing our methodology for codes
with site-of-service anomalies, we
proposed an alternative work RVU of
14.17 with refinements to the time for
CPT code 36825 for CY 2012.
Comment: Commenters disagreed
with the CMS proposed work RVU of
14.17. Commenters disagreed with CMS’
use of the reverse building block
methodology, which removed the
subsequent observation care code and
reduced the full hospital discharge day
management code to a half day, along
with the associated work RVUs and
times. Commenters noted that the AMA
RUC originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Commenters contend that if the patient
is stable and can safely be discharged on
a day subsequent to the day of the
procedure, then there should be no
reduction in discharge management
work. Commenters requested that CMS
reconsider this issue and accept the
AMA RUC-recommended work RVU of
15.13 as a valid relative measure using
magnitude estimation and comparison
to codes with similar work and
intensity.
Response: Based on comments
received, we referred CPT code 36825 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 15.13,
which is consistent with AMA RUC
recommendation to maintain the current
(CY 2011) work RVU for this service.
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The current (CY 2011) work RVU for
this service was developed when this
service was typically furnished in the
inpatient setting. As this service is now
typically furnished in the outpatient
setting, we believe that it is reasonable
to expect that there have been changes
in medical practice for these services,
and that such changes would represent
a decrease in physician time or intensity
or both. However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU for CY 2012 of 14.17 with
refinements to the time for CPT code
36825 for CY 2012. CMS time
refinements can be found in Table 16.
For CY 2012, we received no
comments on the Fourth Five-Year
Review of Work proposed work RVUs
for CPT codes 33916, 33975, 33976,
33977, 33978, 33979, 33981, 33982,
33983, 36200, 36246, 36470, 36471,
36600, 36821, 37140, 37145, 37160,
37180, and 37181. Additionally, we
received no comments on the CY 2011
final rule with comment period work
RVUs for CPT codes 33620, 33621,
33622, 33860, 33863, 33864, 34900,
35471, 36410, 37205, 37206, 37207,
37208, 37220, 37221, 37222, 37223,
37224, 37225, 37226, 37228, 37229,
27230, 37231, 37232, 37233, 37234,
37235, 37765, 37766. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
(14) Digestive: Salivary Glands and
Ducts (CPT Codes 42415–42440)
In the Fourth Five-Year Review, we
identified CPT codes 42415 and 42420
as potentially misvalued through the
site-of-service anomaly screen. The
related specialty societies surveyed
these codes and the AMA RUC issued
recommendations to us for the Fourth
Five-Year Review of Work.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32447), for CPT
code 42415 (Excision of parotid tumor
or parotid gland; lateral lobe, with
dissection and preservation of facial
nerve), we proposed a work RVU of
17.16 for CY 2012. Medicare PFS claims
data indicated that CPT code 42415 is
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typically furnished in an outpatient
setting. However, the current AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 42415,
we removed the observation care
service, reduced the discharge day
management service by one-half, and
adjusted the physician times
accordingly. The AMA RUC
recommended maintaining the current
work RVU of 18.12 for CPT code 42415.
Furthermore, as detailed in the Fourth
Five-Year Review of Work (76 FR
32447), for CPT code 42420 (Excision of
parotid tumor or parotid gland; total,
with dissection and preservation of
facial nerve) we proposed a work RVU
of 19.53 for CY 2012. Medicare PFS
claims data indicated that CPT code
42420 is typically furnished in an
outpatient setting. However, the current
AMA RUC-recommended values for this
code reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 42420,
we removed the subsequent observation
care service, reduced the discharge day
management service by one-half, and
adjusted the physician times
accordingly. The AMA RUC
recommended maintaining the current
work RVU of 21.00 for CPT code 42420.
Comment: Commenters disagreed
with the proposed work RVUs for CPT
codes 42415 and 42420 and requested
that CMS accept the AMA RUCrecommended RVUs of 18.12 and 21.00,
respectively, for these services.
Commenters stated that patients
typically stay overnight, receiving these
specific services require close
monitoring for airway patency,
formation of hematoma, and facial nerve
function, and for 42420, intervention for
any noted deficits, drain function, and
control of nausea. Moreover,
commenters stated that survey data
show that the typical patient receives
this procedure in the hospital (91
percent for 42415 and 97 percent for
42420) and receives an E/M service on
the same date (53 percent for 42415 and
64 percent for 42420). Commenters also
noted that whether or not the service is
designated outpatient or inpatient, the
physician work is the same.
Commenters requested that CMS not
apply the site-of-service anomaly
reductions to work RVUs and physician
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73133
times, and accept the AMA RUC
recommended RVUs of 18.12 for 42415
and 21.00 for 42420.
Response: Based on the public
comments received, we referred both
CPT codes 42415 and 42420 to the CY
2011 multi-specialty refinement panel
for further review. The refinement panel
median work RVUs were 18.12 for
42415 and 21.00 for 42420, which was
consistent with the AMA RUC
recommendation to maintain the current
(CY 2011) work RVUs. The current (CY
2011) work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. Therefore, we
removed the subsequent observation
care services, reduced the discharge day
management service to one-half, and
increased the post-service times. We are
finalizing work RVUs of 17.16 for CPT
code 42415 and 19.53 for CPT code
42420 with refinements to physician
time. CMS time refinements can be
found in Table 16.
As detailed in the CY 2012 PFS
proposed rule (76 FR 42799), for CPT
code 42440 (Excision of submandibular
(submaxillary) gland), we proposed a
work RVU of 6.14 for CY 2012. As stated
in section III.A. of this final rule with
comment period, we believe the
appropriate methodology for valuing
site-of-service anomaly codes entails not
just removing the inpatient visits, but
also accounting for the removal of the
inpatient visits in the work value of the
CPT code. To appropriately revalue this
CPT code to reflect an outpatient service
we started with the original CY 2008
work RVU of 7.05 then, in accordance
with the policy discussed in section
III.A. of this final rule with comment
period, we removed the value of the
subsequent hospital care service and
one-half discharge day management
service, and added back the subsequent
hospital care intra-service time to the
immediate post-operative care service.
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The AMA RUC recommended
maintaining the current work RVU of
7.13 for CPT code 42440 (76 FR 42799).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
6.14 for CPT code 42440 and believe
that the AMA RUC-recommended work
RVU of 7.13 was more appropriate for
this service. Commenters disagreed with
CMS’ use of the reverse building block
methodology, which removed the work
RVUs associated with the subsequent
hospital care code and half a hospital
discharge day management service.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Commenters also noted that there was
an increase in intensity of office visits,
because rather than an overnight stay in
the hospital, the typical patient is
discharged the same day with tubes in
their neck, and a more intense office
visit is needed to remove the tube and
manage other dressings.
Response: Based on the public
comments received, we referred CPT
code 42440 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work was 7.13, which was consistent
with AMA RUC recommendation to
maintain the current (CY 2011) work
RVU for this service. The current (CY
2011) work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation does not reflect a
decrease in physician work. We believe
the appropriate methodology for valuing
site-of-service anomaly codes entails not
just removing the inpatient visits, but
also accounting for the removal of the
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inpatient visits in the work value of the
CPT code. Furthermore, we believe it is
appropriate to remove the value of the
subsequent hospital care service and
one-half discharge day management
service, and add back the subsequent
hospital care intra-service time to the
immediate post-operative care service.
Therefore, we are finalizing a work RVU
for CPT code 42440 of 6.14 with
refinements to time. CMS time
refinements can be found in Table 16.
(15) Digestive: Esophagus (CPT codes
43262, 43327–43328, and 43332–43338)
As detailed in the Fourth Five-Year
Review (76 FR 32448), for CPT code
43262 (Endoscopic retrograde
cholangiopancreatography (ERCP); with
sphincterotomy/papillotomy), we
believed that the current (CY 2011)
work RVU of 7.38 continued to
accurately reflect the work of this
service. We proposed to maintain the
current work RVU and physician times
for CPT code 43262. The AMA RUC
recommended maintaining the current
work RVUs for these services as well.
However, the AMA RUC recommended
a pre-service evaluation time of 15
minutes and immediate post service
time of 20 minutes. Additionally, the
AMA RUC recommended a pre-service
positioning time of 5 minutes; a preservice dress/scrub time of 5 minutes;
and an intra-service time of 45 minutes.
We noted that based on a preliminary
review of the intra-service times for
these codes, we were concerned the
codes in this family are potentially
misvalued. We requested that the AMA
RUC undertake a comprehensive review
of the entire family of ERCP codes,
including the base CPT code 43260, and
provide us with work RVU
recommendations.
Comment: In its public comments to
CMS on the Fourth Five-Year Review,
the AMA RUC stated that it intends to
review this family of codes in 2012. The
AMA RUC also noted that CMS
disagreed with the AMA RUCrecommended physician times for CPT
code 43262. The AMA RUC requested
that CMS accept the AMA RUCrecommended times be utilized for CY
2012.
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Response: We appreciate the AMA
RUC accepting family of ERCP codes for
review in 2012. We continue to have
concerns about the recommended intraservice times for this code, and believe
it is appropriate to maintain the current
physician times. CMS time refinements
can be found in Table 16.
For CY 2012, we did not receive any
public comments on the Fourth FiveYear Review proposed work RVUs for
CPT code 43262. We believe this value
continues to be appropriate and are
finalizing it without modification (Table
15).
For CY 2011 the CPT Editorial Panel
deleted six existing CPT codes and
created ten new CPT codes (CPT codes
43283, 43327–43328, 43332–43338) to
better report current surgical techniques
for paraesophageal hernia procedures.
The specialty societies surveyed their
members, and the AMA RUC issued
recommendations to us for the CY 2011
PFS final rule with comment period.
As stated in the CY 2011 PFS final
rule with comment period, after
reviewing these new CPT codes, we
believed that this coding change
resulted in more codes that describe the
same physician work with a greater
degree of precision, and that the
aggregate increase in work RVUs that
would result from the adoption of the
CMS-adjusted pre-budget neutrality
RVUs would not represent a true
increase in physician work. Therefore,
we believed it was appropriate to apply
work budget neutrality to this set of CPT
codes. After reviewing the AMA RUCrecommended work RVUs, we adjusted
the work RVUs for two CPT codes (CPT
code 43333 and 43335), and then
applied work budget neutrality to the
set of clinically related CPT codes. The
work budget neutrality factor for the 10
paraesophageal hernia procedure CPT
codes was 0.7374. The AMA RUCrecommended work RVU, CMS-adjusted
work RVU prior to the budget neutrality
adjustment, and the CY 2011 interim
final work RVU for these
paraesophageal hernia procedure codes
follow (CPT codes 43283, 43327–43328,
43332–43338) (75 FR 73338).
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As mentioned previously, and
detailed in the CY 2011 PFS final rule
with comment period, for CPT codes
43333 (Repair, paraesophageal hiatal
hernia (including fundoplication), via
laparotomy, except neonatal; with
implantation of mesh or other
prosthesis) and 43335 (Repair,
paraesophageal hiatal hernia (including
fundoplication), via thoracotomy,
except neonatal; with implantation of
mesh or other prosthesis), we disagreed
with the AMA RUC-recommended work
RVUs and assigned alternate RVUs prior
to the application of work budget
neutrality (75 FR 73331). For CPT code
43333 we assigned a pre-budget
neutrality work RVU of 29.10 and for
CPT code 43335 we assigned a prebudget neutrality work RVU of 32.50.
We arrived at these values by starting
with the AMA RUC-recommended
values for the repair of papaesophageal
hernia without mesh, CPT codes 43332
(Repair, paraesophageal hiatal hernia
(including fundoplication), via
laparotomy, except neonatal; without
implantation of mesh or other
prosthesis) and 43334 (Repair,
paraesophageal hiatal hernia (including
fundoplication), via thoracotomy,
except neonatal; without implantation
of mesh or other prosthesis) then
adjusted them upward by a work RVU
of 2.50 to account for the incremental
difference associated with the
implantation of mesh or other
prosthesis. The AMA RUC
recommended a work RVU of 30.00 for
CPT code 43333 and a work RVU of
33.00 for CPT 43335 for CY 2011.
Comment: Commenters disagreed
with the application of work budget
neutrality to this set of services and
noted that the specialty societies and
AMA RUC agreed that there was
compelling evidence that technology
has changed the physician work to
repair esophageal hernias. Commenters
stated that the work described by the
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deleted CPT codes was intended for
patients with acid reflux or blockage
and that, with the advent of medical
management and less invasive
treatments, the patients’ currently
undergoing surgery are symptomatic,
typically with blockage. They stated that
the typical patient has more advanced
disease and requires more complex
repair. Commenters also stated that the
CY 2011 interim final values would
create rank order anomalies between
these CPT codes and other major
inpatient surgical procedures.
With regard to CPT codes 43333 and
43335, commenters disagreed with the
CMS-assigned pre-budget neutrality
work RVU of 29.10 for CPT code 43333
and 32.50 for CPT code 43335, and
believe that the AMA RUCrecommended work RVUs of 30.00 for
CPT code 43333 and 33.00 for CPT code
43335 are more appropriate for these
services. Commenters noted that CMS
adjusted the AMA RUC-recommended
values for CPT codes 43333 and 43335
by 2.50 work RVUs, an increment
established in the AMA RUC’s valuation
of CPT codes 43336 and 43337. In other
words CMS added 2.50 work RVUs to
the AMA RUC-recommended work
RVUs of 26.60 for CPT code 43332,
which resulted in a value of 29.10 for
CPT code 43333. Also, CMS added 2.50
work RVUs to the AMA RUCrecommended work RVUs of 30.00 for
CPT code 43334, which resulted in a
value of 32.50 for CPT code 43335.
Commenters disagreed with this method
because CMS’ interim values were not
supported by the survey results or AMA
RUC recommendations. Commenters
note that the AMA RUC
recommendations were based on
magnitude estimation rather than the
building block methodology, which
considers the total work of the service
rather than the work of the component
parts of the service. Commenters did not
agree with adding component parts on
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73135
to values that were based through
magnitude estimation. Commenters
asserted that these,services should be
valued through magnitude estimation,
rather than incremental addition of
work RVUs of 2.50 in order to account
for both the work related to inserting
mesh, as well as other patient factors
that in turn make the insertion of mesh
necessary. Based on these arguments,
commenters stated that work budget
neutrality should not be applied to these
codes, and urged CMS to accept the
AMA RUC-recommended values for
these services.
Response: Based on comments
received, we referred this set of
paraesophageal hernia procedures (CPT
codes 43283, 43327–43328, and 43332–
43338) to the CY 2011 multi-specialty
refinement panel for further review.
Though the refinement panel median
work RVUs were work RVUs of 30.00
for CPT code 43333 and 33.00 for CPT
43335, which were consistent with the
AMA RUC-recommended values for
these services. We continue to believe
that the application of work budget
neutrality is appropriate for this set of
clinically related CPT codes. While we
understand that the practice of medicine
has changed since these codes were
originally valued, we do not believe
these changes have resulted in more
aggregate physician work. As such, we
believe that allowing an increase in
utilization-weighted RVUs within this
set of clinically related CPT codes
would be unjustifiably redistributive
among PFS services. Additionally, we
continue to believe that a work RVU of
2.50, which was based on a differential
that was recommended by the AMA
RUC between a pair of with/without
implantation of mesh codes in this
family, appropriately accounts for the
incremental difference in work between
CPT codes 43332 and 43333, and 43334
and 43335. After consideration of the
public comments, refinement panel
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hernia procedures (CPT codes 43283,
43327–43328, and 43332–43338) for CY
2012. The CY 2012 final work RVUs for
these services are as follows:
Additionally, we received no public
comments on the Fourth Five-Year
Review proposed work RVUs for CPT
code 43415. We believe these values
continue to be appropriate and are
finalizing them without modification
(Table 15).
accept the AMA RUC recommended
intra-service time of 15 minutes for CPT
code 45331.
Response: In response to comments,
we re-reviewed CPT code 45331. After
reviewing the descriptions of preservice work and the recommended preservice time packages, we disagree with
the times recommended by the AMA
RUC. For CPT code 45331 we are
finalizing a work RVU of 1.15. In
addition, we are finalizing the following
times for CPT code 45331: 5 minutes for
pre-evaluation; 5 minutes for pre-service
other, 5 minutes for pre- dress, scrub,
and wait; 10 minutes intra-service; and
10 minutes immediate post-service.
CMS time refinements can be found in
Table 16.
(more than 24 hours).’’ These responses
make no distinction between the
patient’s status as an inpatient or
outpatient of the hospital for stays of
longer than 24 hours. Based on the
survey data, we valued this service
based on our methodology to address
23-hour stay site-of-service anomaly
services.
As we discussed in section III.A. of
this final rule with comment period, for
codes with site-of-service anomalies,
our policy is to remove any postprocedure inpatient visits remaining in
the values for these codes and adjust
physician times accordingly. It is also
our policy for codes with site-of-service
anomalies to consistently include the
value of half of a discharge day
management service, adjusting
physician times accordingly. The AMA
RUC recommended that this service be
valued as a service furnished
predominately in the facility setting
with a work RVU of 12.11 for CPT code
47563 (76 FR 32448).
Comment: Commenters disagreed
with the proposed work RVU of 11.47,
and supported the AMA RUCrecommended work RVU of 12.11 for
CPT code 47563. Commenters disagreed
with CMS’ methodology to address 23hour stay site-of-service anomaly
services of removing half of a discharge
day management service. Commenters
noted the change in physician work in
the past five years; specifically, a more
complex patient population.
Commenters also stated that the
physician’s discharge work remains the
same, independent of facility status.
Commenters stated that CPT code 47563
is more intense and has a higher intraservice time than the key reference code
47562 (Laparoscopy, surgical;
cholecystectomy), and cautioned against
a rank order anomaly within the family
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(16) Digestive: Rectum (CPT code
45331)
As detailed in the Fourth Five-Year
Review, for CPT code 45331
(Sigmoidoscopy, flexible; with biopsy,
single or multiple) we believed that the
current (CY 2011) work RVUs continued
to accurately reflect the work of these
services and, therefore, proposed a work
RVU of 1.15 for CPT code 45331. The
AMA RUC recommended maintaining
the current work RVUs for this service
as well. For CPT code 45331, the AMA
RUC recommended a pre-service time of
15 minutes, intra-service time of 15
minutes, and post-service time of 10
minutes. While the AMA RUC
recommended pre-service times based
on the 75th percentile of the survey
results, we believed it was more
appropriate to accept the median survey
physician times. Accordingly, we
proposed to refine the times to the
following: 5 minutes for pre-evaluation;
5 minutes for pre-service other, 5
minutes for pre- dress, scrub, and wait;
10 minutes intra-service; and 10
minutes immediate post-service (76 FR
32448).
Comment: In its public comment to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that CMS agreed
with the AMA RUC recommended work
RVU, but noted that CMS disagreed
with the AMA RUC recommended time
components. The commenters further
noted that CMS proposed to use the
median survey time for CPT code 45331.
The AMA RUC recommends that CMS
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(17) Digestive: Biliary Tract (CPT Codes
47480, 47490, 47563, and 47564)
In the Fourth Five-Year Review, CMS
identified CPT code 47563 as
potentially misvalued through the
Harvard Valued—Utilization > 30,000
screen and site-of-service anomaly
screen. The AMA RUC reviewed CPT
codes 47564 and 47563.
As detailed in the Fourth Five-Year
Review (76 FR 32448), for CPT code
47563 (Laparoscopy, surgical;
cholecystectomy with cholangiography),
we proposed a work RVU of 11.47 with
refinements in time for CPT code 47563
for CY 2012. The survey data show 95
percent (57 out of 60) of survey
respondents stated they furnish the
procedure ‘‘in the hospital.’’ However,
of those respondents who stated that
they typically furnish the procedure in
the hospital, 30 percent (17 out of 57)
stated that the patient is ‘‘discharged the
same day’’; 46 percent (26 out of 57)
stated the patient is ‘‘kept overnight
(less than 24 hours)’’; and 25 percent (14
out of 57) stated the patient is ‘‘admitted
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results, and our clinical review, we are
finalizing the CY 2011 interim final
work RVU values for paraesophageal
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with CPT code 47562 (work RVU =
11.76). Commenters requested that CMS
accept the AMA RUC-recommended
work RVU of 12.11 and include a full
day discharge service for CPT code
47563.
Response: Based on the comments we
received, we referred CPT code 47563 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 12.11,
which was consistent with the AMA
RUC recommendation and the current
(CY 2011) work RVU. The current (CY
2011) work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this 23-hour stay service
to continue to reflect work that is
typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are finalizing a work
RVU of 11.47 to CPT code 47563. CMS
time refinements can be found in Table
16.
As detailed in the Fourth Five-Year
Review (76 FR 32449), for CPT code
47564 (Laparoscopy, surgical;
cholecystectomy with exploration of
common duct), we proposed a work
RVU of 18.00, the survey low work
RVU, for CY 2012. We accepted the
AMA RUC-recommended median
survey times and believed the work
RVU of 18.00 for CPT code 35860 was
more appropriate given the significant
reduction in recommended physician
times in comparison to the current
times. The AMA RUC recommended a
work RVU of 20.00, the 25th survey
percentile, for CPT code 47564.
Comment: Commenters disagreed
with the proposed work RVU of 18.00,
and supported the AMA RUCrecommended work RVU of 20.00 for
CPT code 47564. Commenters disagreed
with CMS’ acceptance of the survey
low, while the AMA RUC recommended
the 25th survey percentile. Commenters
noted that the physician times for CPT
code 47564 were crosswalked in 1994
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and were not accurate. Therefore, they
state that reducing the work value based
on the reduction in physician time is
not appropriate.
Response: Based on comments we
received, we referred CPT code 47564 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 20.00,
which was consistent with the AMA
RUC recommendation for this service.
We find that the median survey times,
recommended by the AMA RUC, do not
support the AMA RUC-recommended
increase in work RVUs. We believe that
the proposed work RVU is more
appropriate with the AMA RUCrecommended physician times that we
accepted. After consideration of the
public comments, refinement panel
results, and our clinical review, we are
finalizing a work RVU of 18.00 for CPT
code 47564. CMS time refinements can
be found in Table 16.
For CY 2012, we received no
comments on the Fourth Five-Year
Review proposed work RVUs for CPT
codes 47480 and 47490. We believe
these values continue to be appropriate
and are finalizing them without
modification (Table 15).
(18) Digestive: Abdomen, Peritoneum,
and Omentum (CPT codes 49324–
49655)
We discussed CPT codes 49507
(Repair initial inguinal hernia, age 5
years or over; incarcerated or
strangulated), 49521 (Repair recurrent
inguinal hernia, any age; incarcerated or
strangulated), and 49587 (Repair
umbilical hernia, age 5 years or over;
incarcerated or strangulated) in the
Fourth Five-Year Review (76 FR 32449)
where we noted these codes were
identified as codes with a site-ofservice anomaly. Medicare PFS claims
data indicated that these codes are
typically furnished in an outpatient
setting. However, the current and AMA
RUC-recommended values for these
codes reflected work that is typically
associated with an inpatient service. As
discussed in section III.A. of this final
rule with comment period, our policy is
to remove any post-procedure inpatient
and subsequent observation care visits
remaining in the values for these codes
and adjust physician times accordingly.
It is also our policy for codes with siteof- service anomalies to consistently
include the value of half of a discharge
day management service. While the
AMA RUC recommended maintaining
the current work RVUs, utilizing our
methodology, we proposed an
alternative work RVU of 9.09 for CPT
code 49507, 11.48 for CPT code 49521,
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and 7.08 for CPT code 49587, with
appropriate refinements to the time.
Comment: Commenters disagreed
with the CMS-proposed work RVU for
CPT codes 49507 49521, and 49587. The
commenters noted that for these three
hernia repair codes, the AMA RUC
survey data show 98–100 percent of
survey respondents stated they furnish
the procedure ‘‘in the hospital.’’
Commenters disagreed with CMS’ use of
the reverse building block methodology,
which removed the subsequent
observation care code and reduced the
full hospital discharge day management
code to a half day, along with the
associated work RVUs and times.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Commenters requested that CMS
reconsider this issue and accept the
AMA RUC recommended work RVU as
a valid relative measure using
magnitude estimation and comparison
to codes with similar work and
intensity.
Response: Based on comments
received, we referred CPT codes 49507,
49521, and 49587 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVUs were 10.05 for CPT code
49507, 12.44 for CPT code 49521, and
8.04 for CPT code 49587, which was
consistent with the AMA RUC
recommendation to maintain the current
(CY 2011) work RVU for this service.
The current (CY 2011) work RVU for
this service was developed when this
service was typically furnished in the
inpatient setting. As this service is now
typically furnished in the outpatient
setting, we believe that it is reasonable
to expect that there have been changes
in medical practice for these services,
and that such changes would represent
a decrease in physician time or intensity
or both. However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. While the commenter noted that
the survey respondents overwhelmingly
indicated that they furnish this
procedure ‘‘in the hospital,’’ the
Medicare claims data show these
patients are typically in the hospital as
outpatients, not inpatients and we do
not believe that maintaining the current
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value, which reflects work that is
typically associated with an inpatient
service, is appropriate. In order to
ensure consistent and appropriate
valuation of physician work, we believe
it is appropriate to apply our
methodology described previously to
address 23-hour stay site-of-service
anomalies. After consideration of the
public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
9.09 for CPT code 49507, 11.48 for CPT
code 49521, and 7.08 for CPT code
49587, with appropriate refinements to
the time. CMS time refinements can be
found in Table 16.
We discussed CPT code 49652
(Laparoscopy, surgical, repair, ventral,
umbilical, spigelian or epigastric hernia
(includes mesh insertion, when
performed); reducible), CPT code 49653
(Laparoscopy, surgical, repair, ventral,
umbilical, spigelian or epigastric hernia
(includes mesh insertion, when
performed); incarcerated or
strangulated), CPT code 49654
(Laparoscopy, surgical, repair,
incisional hernia (includes mesh
insertion, when performed); reducible),
and CPT code 49655 (Laparoscopy,
surgical, repair, incisional hernia
(includes mesh insertion, when
performed)) in the Fourth Five-Year
Review of Work (76 FR 32450–32452)
where we noted these codes were
identified as codes with a sites-ofservices anomaly. Medicare PFS claims
data indicated that these codes are
typically furnished in an outpatient
setting. However, the current and AMA
RUC-recommended values for these
codes reflected work that is typically
associated with an inpatient service. As
discussed in section III.A. of this final
rule with comment period, our policy is
to remove any post-procedure inpatient
and subsequent observation care visits
remaining in the values for these codes
and adjust physician times accordingly.
It is also our policy for codes with siteof-service anomalies to consistently
include the value of half of a discharge
day management service. While the
AMA RUC recommended maintaining
the current work RVUs, utilizing our
methodology, we proposed an
alternative work RVU of 11.92 with
refinements to the time for CPT code
49652, 14.92 with refinements to the
time for CPT code 49653, 13.76 with
refinements to the time for CPT code
49654, and 16.84 with refinements to
the time for CPT code 49655.
Comment: Commenters disagreed
with the CMS-proposed work RVU for
CPT codes 49652, 49653, 49654, and
49655. Commenters noted that similar
to the three hernia repair codes
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previously discussed, the AMA RUC
survey data show 98–100 percent of
survey respondents stated they furnish
these laparoscopic hernia repair
procedures ‘‘in the hospital.’’
Commenters disagreed with CMS’ use of
the reverse building block methodology,
which removed the subsequent
observation care codes and reduced the
full hospital discharge day management
code to a half day, along with the
associated work RVUs and times.
Commenters noted that the AMA RUC
originally valued this service using
magnitude estimation based on
comparison reference codes, which
considers the total work of the service
rather than the work of the component
parts of the service, and requested CMS
accept the AMA RUC-recommended
work RVU and physician time.
Commenters also contended the
surgeon’s post-operative work has not
changed and has not become easier
because of a change in facility
designation. Commenters requested that
CMS reconsider this issue and accept
the AMA RUC recommended work RVU
as a valid relative measure using
magnitude estimation and comparison
to codes with similar work and
intensity.
Response: Based on comments
received, we referred CPT codes 49652,
49653, 49654, and 49655 to the CY 2011
multi-specialty refinement panel for
further review. The refinement panel
median work RVUs were 12.88, 16.21,
15.03, and 18.11 for CPT codes 49652,
49653, 49654, and 49655, respectively,
which were consistent with the AMA
RUC recommendation to maintain the
current work RVUs for this services. The
current (CY 2011) work RVU for this
service was developed when this service
was typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. We note again that while survey
respondents overwhelmingly indicated
that they furnish these procedures ‘‘in
the hospital,’’ the Medicare claims data
show these patients are typically in the
hospital as outpatients, not inpatients
and we do not believe that maintaining
the current value, which reflects work
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that is typically associated with an
inpatient service, is appropriate. In
order to ensure consistent and
appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU for CY 2012 of 11.92 with
refinements to the time for CPT code
49652, 14.92 with refinements to the
time for CPT code 49653, 13.76 with
refinements to the time for CPT code
49654, and 16.84 with refinements to
the time for CPT code 49655.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 49324, 49327,
49412, 49418, 49419, 49421, and 49422.
We believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
(19) Urinary System: Bladder (CPT
Codes 51705–53860)
As detailed in the Fourth Five-Year
Review, for CPT code 51710 (Change of
cystostomy tube; complicated), we
agreed with the AMA RUCrecommended work RVU, and proposed
a work RVU of 1.35 for CY 2012. The
AMA RUC noted that a request was sent
to CMS to have the global service period
changed from a 10-day global period
(010) to a 0-day global period (000),
which only includes RVUs for the same
day pre- and post-operative period. The
AMA RUC indicated that in the
standards of care for this procedure,
there is no hospital time and there are
no follow up visits. The AMA RUC also
noted that while the service was
surveyed as a 10-day global, the
respondents inadvertently included a
hospital visit, CPT code 99231
(Subsequent hospital care), and
removed the RVUs for that visit.
Consequently, the AMA RUC did not
use the survey results to value the code.
Rather, comparing the physician work
within the family of services, the AMA
RUC compared CPT code 51710 to CPT
code 51705 (Change of cystostomy tube;
simple) and recommended a work RVU
of 1.35 for CPT code 51710.
We agreed to change the global period
from a 10-day global to 0-day global.
However, we noted that while we
believed that changing a cystostomy
tube in a complicated patient may be
more time consuming than in a patient
that requires a simple cystostomy tube
change, we believed that the
prepositioning time is unnecessarily
high given the recommended prepositioning time of 5 minutes for CPT
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code 51705, which has an identical prepositioning work description. Hence, we
proposed refinements in time for CPT
code 51710 for CY 2012 (76 FR 32452).
Comment: In their public comment to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that CMS agreed
with the AMA RUC recommended work
RVU and the request to change the
global period from a 10-day global to
0-day global period. Commenters
disagreed with CMS that the pre-service
positioning time is identical between
codes 51710 and 51705. Commenters
also state that the service does require
more time for positioning since many
times patients must be transferred from
a wheelchair to an examination table.
Lastly, commenters recommend that
CMS accept the AMA RUCrecommended pre-service positioning
time of 10 minutes for CPT code 51710.
Response: In response to comments,
we re-reviewed CPT code 51710. After
reviewing the descriptions of preservice work and the recommended preservice time packages, we continue to
disagree with the times recommended
by the AMA RUC. We believe that the
prepositioning time is unnecessarily
high given the recommended prepositioning time of 5 minutes for CPT
code 51705, which has an identical prepositioning work description. For CPT
code 51710, we are finalizing a work
RVU of 1.35. In addition, we are
finalizing the following times for CPT
code 51710: 7 minutes for preevaluation; 5 minutes for pre-service
positioning, 15 minutes for intraservice; and 15 minutes post-service.
CMS time refinements can be found in
Table 16.
CPT codes 52281 (Cystourethroscopy,
with calibration and/or dilation of
urethral stricture or stenosis, with or
without meatotomy, with or without
injection procedure for cystography,
male or female) and 52332
(Cystourethroscopy, with insertion of
indwelling ureteral stent (e.g., Gibbons
or double-J type)) were identified as a
potentially misvalued code through the
Five-Year Review Identification
Workgroup under the Harvard-Valued
potentially misvalued codes screen for
services with utilization over 100,000.
As detailed in the CY 2011 final rule
with comment period (75 FR 73339), for
CPT code 52281, we assigned an interim
final work RVU of 2.60. The AMA RUC
reviewed the survey results and
determined that the physician time of
16 minutes pre-, 20 minutes intra-, and
10 minutes immediate post-service time
and maintaining the current work RVUs
of 2.80 appropriately accounted for the
time and work required to furnish this
procedure. We disagreed with the AMA
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RUC recommendation to maintain the
current RVUs for this code because the
physician time to furnish this service (a
building block of the code) has changed
since the original ‘‘Harvard values’’
were established, as indicated by the
AMA RUC-recommended reduction in
pre-service time. Accounting for the
reduction in pre-service time, we
calculated work RVUs that were close to
the survey 25th percentile.
Comment: Commenters disagreed
with the interim final work RVU of 2.60.
Commenters acknowledged that CPT
code 52281 had significant reductions to
the pre-service times. However,
commenters stated that the work for this
service had not changed. Commenters
asserted that because this service was
valued using magnitude estimation
based on comparison reference codes,
which considers the total work of the
service rather than the work of the
component parts of the service, it is not
appropriate to remove RVUs based on
time (a building block of the code). For
CPT code, commenters requested that
CMS accept the AMA RUCrecommended work RVU of 2.80.
Response: Based on the comments
received, we referred CPT code 52281 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 2.75. As
a result of the refinement panel ratings
and clinical review by CMS, we are
assigning a work RVU of 2.75 to CPT
code 52281 as the final value for CY
2012.
As detailed in the CY 2011 final rule
with comment period (75 FR 73339), for
CPT code 52332, we assigned an interim
final work RVU of 2.60. We disagreed
with the AMA RUC’s CY 2011 work
RVU recommendation to maintain the
current value due significant reduction
in pre-service time. Based on the same
building block rationale we applied to
CPT code 52281, the other code within
this family, we believed 2.60, which is
the survey 25th percentile and
maintains rank order, was a more
appropriate valuation for 52332.
Comment: Commenters believed that
CMS made a mistake on the valuation
for code 52332 in the CY 2011 PFS final
rule with comment period. The
information in the final rule with
comment period prior to correction
stated that the 25th percentile work
RVU was 1.47. The commenters noted
that the RUC states that the 25th
percentile is 3.20 not 1.47 as stated in
the final rule. Additionally, the
commenters stated that if CMS
maintains the 1.47 work RVU, then
52332 will have less value than
cystoscopy (52000) at 2.23 work RVUs.
Moreover, commenters stated that the
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73139
procedure identified as 52332 is a more
intense procedure than 52000.
Commenters also acknowledged that
CPT code 52332 had significant
reductions to the pre-service times.
However, commenters stated that the
work for this service had not changed.
Commenters asserted that because this
service was valued using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, it is not appropriate to remove
RVUs based on time (a building block of
the code). For CPT code, commenters
requested that CMS accept the AMA
RUC-recommended work RVU of 2.83.
Response: We corrected a
typographical error in the CY 2011 PFS
final rule with comment period that
improperly valued the work RVU for
CPT code 52332 at 1.47, instead of the
interim final work RVU of 2.60 for CY
2011 (76 FR 1673). Based on the
comments received, we referred CPT
code 52332 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVU was 2.82. As a result of the
refinement panel ratings and clinical
review by CMS, we are assigning a work
RVU of 2.82 for CPT code 52332 as the
final value for CY 2012.
In the Fourth Five-Year Review, we
identified CPT codes 51705, 52005 and
52310 as potentially misvalued through
the Harvard-Valued—Utilization
> 30,000 screen. CPT codes 51710,
52007 and 52315 were added as part of
the family of services for AMA RUC
review. In addition, we identified CPT
codes 52630, 52649, 53440 and 57288 as
potentially misvalued through the siteof-service anomaly screen. The specialty
agreed to add CPT codes 52640 and
57287 as part of the family of services
for AMA RUC review.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32452), for CPT
code 52630 (Transurethral resection;
residual or regrowth of obstructive
prostate tissue including control of
postoperative bleeding, complete
(vasectomy, meatotomy,
cystourethroscopy, urethral calibration
and/or dilation, and
internalurethrotomy are included)), we
proposed a work RVU of 6.55 for CY
2012. Medicare PFS claims data
indicated that CPT code 52630 is
typically furnished in an outpatient
setting. However, the current AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
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in section III.A. of this final rule with
comment period, for CPT code 52630,
we removed the post procedure
inpatient visit remaining in the AMA
RUC-recommended value and adjusted
the physician times accordingly. We
also reduced the discharge day
management service by one-half. The
AMA RUC recommended maintaining
the current work RVU of 7.73 for CPT
code 52630.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
6.55 for CPT code 52630 and believe
that the AMA RUC-recommended work
RVU of 7.73 is more appropriate for this
service. The commenters disagreed with
CMS’ reduction to half of a discharge
day management service. Furthermore,
commenters stated that one full
discharge day management code (either
99238 or 99217 1.28 RVU) should be
included in the valuation of 52630. The
commenters asserted that there was not
appropriate justification for CMS to
remove 0.64 work RVUs from the RUC’s
recommendation to reduce the full day
of discharge management services to
one-half day. Commenters also stated
that the AMA RUC-recommended
physician time should be restored.
Response: Based on comments
received, we referred CPT code 52630 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 7.14. The
AMA RUC recommended maintaining
the current (CY 2011) work RVU of 7.73.
The current (CY 2011) work RVU for
this service was developed when this
service was typically furnished in the
inpatient setting. As this service is now
typically furnished in the outpatient
setting, we believe that it is reasonable
to expect that there have been changes
in medical practice for these services,
and that such changes would represent
a decrease in physician time or intensity
or both. However, the AMA RUCrecommendation and refinement panel
results do not adequately reflect a
decrease in physician work. We do not
believe it is appropriate for this now
outpatient service to continue to reflect
work that is typically associated with an
inpatient service. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology
described previously to address 23-hour
stay site-of-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU of 6.55 to CPT code 52630 as the
final value for CY 2012. Therefore, we
are finalizing a pre-service time of 33
minutes, a pre-service positioning time
of 5 minutes, a pre-service (dress, scrub,
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wait) time of 15 minutes, an intraservice time of 60 minutes, and a postservice time of 35 minutes. We are also
reducing the hospital discharge day by
0.5 for CPT code 52630. CMS time
refinements can be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32453), for CPT
code 52649 (Laser enucleation of the
prostate with morcellation, including
control of postoperative bleeding,
complete (vasectomy, meatotomy,
cystourethroscopy, urethral calibration
and/or dilation, internal urethrotomy
and transurethral resection of prostate
are included if performed)), we
proposed a work RVU of 14.56 for CY
2012. Medicare PFS claims data
indicated that CPT code 52649 is
typically furnished in an outpatient
setting. However, the current AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, CPT code 52649, we
reduced the discharge day management
service to one-half and adjusted the
physician times accordingly. The AMA
RUC recommended a work RVU of
15.20 for CPT code 52649.
Comment: Commenters disagreed
with the CMS proposed work RVU of
14.56 for CPT code 52649 and believe
that the AMA RUC-recommended work
RVU of 15.20 is more appropriate for
this service. In addition, the
commenters disagreed that a half-day of
discharge management services is
appropriate for this code. The
commenters support the utilization of a
full discharge day that takes into
account the time the physician spends
returning to the hospital later that night
or the next morning to review charts,
furnish an examination of the patient,
check on post-operative status, speak
with the patient’s family, and provide
any subsequent discharge services that
usually require more than 30 minutes.
Commenters also stated that the AMA
RUC physician time should be restored.
Response: Based on comments
received, we referred CPT code 52649 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 14.88. The
AMA RUC recommendation for this
service was a work RVU of 15.20. The
AMA RUC-recommended work value
for this service included a full discharge
day management service, which we do
not believe is appropriate for an
outpatient service. As this service is
now typically furnished in the
outpatient setting, we believe that it is
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reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. The AMA
RUC-recommendation and refinement
panel results do not adequately reflect
the appropriate decrease in physician
work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU of 14.56 to CPT code 52649 as the
final value for CY 2012. In addition, we
are finalizing a pre-service time of 33
minutes, a pre-service positioning time
of 5 minutes, a pre-service (dress, scrub,
wait) time of 15 minutes, an intraservice time of 120 minutes, and a postservice time of 25 minutes. We are also
reducing the hospital discharge day by
0.5 for CPT code 52649. CMS time
refinements can be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32453), for CPT
code 53440 (Sling operation for
correction of male urinary incontinence
(e.g., fascia or synthetic)), we proposed
a work RVU of 13.36 for CY 2012.
Medicare PFS claims data indicated that
CPT code 53440 is typically furnished
in a hospital setting as an outpatient
service. However, the current AMA
RUC-recommended values for this code
reflected work that is typically
associated with an inpatient service.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 53440,
we reduced the discharge day
management service to one-half. The
AMA RUC recommended a work RVU
of 14.00 for CPT code 53440.
Comment: Commenters disagreed
with the CMS proposed work RVU of
13.36 for CPT code 53440 and believe
that the AMA RUC-recommended work
RVU of 14.00 is more appropriate for
this service. In addition, the
commenters disagreed that a half-day of
discharge management services is
appropriate for this code. The
commenters support the utilization of a
full discharge day that takes into
account the time the physician spends
returning to the hospital later that night
or the next morning to review charts,
furnish an examination of the patient,
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check on post-op status, speak with the
patient’s family, and provide any
subsequent discharge services that
usually require more than 30 minutes.
Commenters also stated that the AMA
RUC-recommended physician time
should be restored.
Response: Based on comments
received, we referred CPT code 53440 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 13.68. The
current (CY 2011) work RVU for this
service was developed when this service
was typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not adequately reflect a
decrease in physician work. We do not
believe it is appropriate for this now
outpatient service to continue to reflect
work that is typically associated with an
inpatient service. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology
described previously to address 23-hour
stay site-of-service anomalies. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are assigning a work
RVU of 13.36 to CPT code 53440 as the
final value for CY 2012. In addition, we
are finalizing a pre-service time of 33
minutes, a pre-service positioning time
of 7 minutes, a pre-service (dress, scrub,
wait) time of 15 minutes, an intraservice time of 90 minutes, and a postservice time of 22 minutes. We are also
reducing the hospital discharge day by
0.5 for CPT code 53440. CMS time
refinements can be found in Table 16.
For CY 2009, CPT code 53445
(Insertion of inflatable urethral/bladder
neck sphincter, including placement of
pump, reservoir, and cuff) was
identified as potentially misvalued
through the site-of-service anomaly
screen. As detailed in the CY 2012 PFS
proposed rule (76 FR 42799), we
proposed a work RVU of 13.00 for CY
2012. Medicare PFS claims data
indicated that CPT code 53445 is
typically furnished in a hospital setting
as an outpatient service. Upon clinical
review of this service and the time and
visits associated with it, we believe that
the survey 25th percentile work RVU of
13.00 appropriately accounts for the
work required to furnish this service (76
F42800).
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Comment: Commenters disagreed
with the CMS-proposed work RVU of
13.00 for CPT code 53445 and stated
that a work RVU of 15.39 is more
appropriate for this service. Some
commenters opposed the reduction in
RVUs for this service and our utilization
of a reverse building block
methodology. Additionally, some
commenters expressed concerns
regarding the use of the 25th percentile
in the CMS and whether this
methodology accounts for the resources
required to furnish this service.
However, the AMA RUC clarified that
the AMA RUC recommendation was
misstated in the proposed rule due to an
error, and that the AMA RUCrecommended work RVU is 13.00 for
CPT 53445.
Response: We agree with the AMA
RUC that the 25th percentile value of
13.00 work RVUs is appropriate for this
service. Therefore, we are finalizing a
work RVU of 13.00 for CPT code 53445
for CY 2012.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 50250, 50542,
51736, 51741, 53860, 55866, and 55876.
Also, for CY 2012, we received no
public comments on the CY 2012
proposed work RVUs for CPT codes
52341, 52342, 52343, 52344, 52345,
52346, 52400, 52500, 54410, and 54530.
Finally, for CY 2012, we received no
public comments on the Fourth FiveYear Review proposed work RVUs for
CPT codes 51705, 52005, 52007, 52310,
52315, and 52640. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
(20) Female Genital System: Vagina
(CPT Codes 57155–57288)
We discussed CPT code 57155
(Insertion of uterine tandems and/or
vaginal ovoids for clinical
brachytherapy) in the CY 2011 PFS final
rule with comment period (75 FR
73330). For CY 2011, the AMA RUC
reviewed survey responses, concluded
that the survey median work RVU
appropriately accounts for the physician
work required to furnish this service,
and recommended a work RVU of 5.40
for CPT code 57155. We disagreed with
the AMA RUC-recommended value for
this service because the description of
the AMA RUC’s methodology was
unclear to us. We believed the work
RVU of 3.37 was more appropriate for
this service, which is the same as the
value assigned to CPT code 58823
(Drainage of pelvic abscess, transvaginal
or transrectal approach, percutaneous
(e.g., ovarian, pericolic)), which we
believed was an appropriate crosswalk.
PO 00000
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73141
Therefore, we assigned an alternative
work RVU of 3.37 to CPT code 57155 on
an interim final basis for CY 2011.
Comment: Commenters disagreed
with this proposed value. Commenters
did not believe comparison of CPT code
57155 to CPT code 58823 was
acceptable, asserting CPT code 57155 is
a much higher intensity procedure that
is not clinically parallel in work or
intensity to CPT code 58823.
Commenters stated that they preferred
CMS accept the AMA RUC
recommendation.
Response: Based on the comments
received, we referred CPT code 57155 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 5.40. As
a result of the refinement panel ratings
and clinical review by CMS, we are
assigning a work RVU of 5.40 to CPT
code 57155 as the final value for CY
2012.
We discussed CPT code 57156
(Insertion of a vaginal radiation
afterloading apparatus for clinical
brachytherapy) in the CY 2011 PFS final
rule with comment period (75 FR
73330). For CY 2011, the AMA RUC
reviewed survey responses, concluded
that the survey 25th work RVU
appropriately accounts for the physician
work required to furnish this service,
and recommended a work RVU of 2.69.
We disagreed with the AMA RUC’s
valuation of the work associated with
this service and determined it was more
appropriate to crosswalk CPT code
57156 to CPT code 62319 (Injection,
including catheter placement,
continuous infusion or intermittent
bolus, not including neurolytic
substances, with or without contrast (for
either localization or epidurography), of
diagnostic or therapeutic substance(s)
(including anesthetic, antispasmodic,
opioid, steroid, other solution), epidural
or subarachnoid; lumbar, sacral
(caudal)) (work RVUs = 1.87), which has
the same intra-service time (30 minutes)
and overall lower total time than the
comparison services referenced by the
AMA RUC. We assigned an alternative
value of 1.87 work RVUs to CPT code
57156 on an interim final basis for CY
2011.
Comment: The commenters disagreed
with interim final value, noting the
AMA RUC recommended the survey
25th percentile value which the
commenters preferred over CMS’
crosswalk. The commenters requested
that CMS accept the AMA RUC
recommendation.
Response: Based on the comments
received, we referred CPT code 57156 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
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(21) Maternity Care and Delivery (CPT
Codes 59400–59410, 59510–59515, and
59610–59622)
CPT codes 54900–59622 were
identified as potentially misvalued
codes ‘‘High IWPUT’’ screen. The
specialty societies surveyed their
members, and the AMA RUC issued
recommendations to us for the CY 2011
PFS final rule with comment period.
As stated in the CY 2011 PFS final
rule with comment period (75 FR
73338), for CY 2011 the AMA RUC
reviewed 17 existing obstetrical care
codes as part of the potentially
misvalued code initiative. The AMA
RUC recommended significant increases
in the work RVUs for some of the
comprehensive obstetrical care codes,
largely to address the management of
labor. While we generally agreed with
the resulting AMA RUC-recommended
rank order of services in this family, we
believed that the aggregate increase in
work RVUs for the obstetrical services
that would result from the adoption of
the CMS-adjusted pre-budget neutrality
work RVUs was not indicative of a true
increase in physician work for the
services. Therefore, we believed that it
would be appropriate to apply work
budget neutrality to this set of CPT
codes. After reviewing the AMA RUCrecommended work RVUs, we adjusted
the work RVUs for several codes, then
applied work budget neutrality to the
set of clinically related CPT codes. The
work budget neutrality factor for the 17
obstetrical care CPT codes was 0.8922.
The AMA RUC-recommended work
RVU, CMS-adjusted work RVU prior to
the budget neutrality adjustment, and
the CY 2011 interim final work RVU for
obstetrical care codes (CPT codes
59400–59410, 59510–59515, and 59610–
59622) follow.
As mentioned previously, and
detailed in the CY 2011 PFS final rule
with comment period, we disagreed
with the AMA RUC-recommended work
RVUs for a subset of the obstetrical care
CPT codes, and assigned alternate RVUs
prior to the application of work budget
neutrality (75 FR 73340). For obstetrical
care services that include postpartum
care with delivery, the AMA RUC
included one CPT code 99214 visit
(Level 4 established patient office or
other outpatient visit). We believed that
one CPT code 99213 visit (Level 3
established patient office or other
outpatient visit) more accurately
reflected the services furnished at this
postpartum care visit. Therefore, for the
obstetrical care services that include
postpartum care following delivery, we
converted the CPT code 99214 visit to
a 99213 visit and revised the work RVUs
accordingly. This includes the following
CPT codes: 59400 (Routine obstetric
care including antepartum care, vaginal
delivery (with or without episiotomy,
and/or forceps) and postpartum care),
59410 (Vaginal delivery only (with or
without episiotomy and/or forceps);
including postpartum care), 59510
(Routine obstetric care including
antepartum care, cesarean delivery, and
postpartum care), 59515 (Cesarean
delivery only; including postpartum
care), 59610 (Routine obstetric care
including antepartum care, vaginal
delivery (with or without episiotomy,
and/or forceps) and postpartum care,
after previous cesarean delivery), 59614
(Vaginal delivery only, after previous
cesarean delivery (with or without
episiotomy and/or forceps); including
postpartum care), 59618 (Routine
obstetric care including antepartum
care, cesarean delivery, and postpartum
care, following attempted vaginal
delivery after previous cesarean
delivery), and 59622 (Cesarean delivery
only, following attempted vaginal
delivery after previous cesarean
delivery; including postpartum care).
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emcdonald on DSK4SPTVN1PROD with RULES2
panel median work RVU was 2.69. As
a result of the refinement panel ratings
and clinical review by CMS, we are
assigning a work RVU of 2.69 to CPT
code 57156 as the final value for CY
2012.
Additionally, we note there were two
other codes in the Female Genital
System: Vagina family for which we
agreed with the AMA RUC
recommendations. We received no
public comments on CPT codes 57287
(Revise/remove sling repair) and 57288
(Repair bladder defect). For CY 2012, we
received no public comments on the
Fourth Five-Year Review of Work
proposed work RVUs for CPT codes
57287 and 57288. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
73143
code 99214, accurately reflects the work
associated with the provision of the
post-partum office visit, and are
maintaining the CMS-adjusted prebudget neutrality RVUs for these
services. After reviewing public
comments and the history of the
valuation of the obstetrical care CPT
codes, we agree with commenters that
the increase in work RVUs reflects a
true increase in aggregate work for this
set of service, and not just a structural
coding change. As such, we are not
applying the budget neutrality scaling
factor of 0.8922 discussed in the CY
2011 PFS final rule with comment
period for these obstetrical care services.
After consideration of the public
comments, refinement panel results,
and our clinical review, we are
finalizing the following values for
obstetrical care services (CPT codes
59400–59410, 59510–59515, and 59610–
59622) for CY 2012:
PFS claims data indicated that CPT code
60220 is typically furnished as an
outpatient rather than inpatient service.
However, the AMA RUC recommended
that this service be valued as a service
furnished predominately in the facility
setting. The AMA RUC indicated that
since the typical patient is kept
overnight, the AMA RUC believes that
one inpatient hospital visit as well as
one discharge day management service
should be maintained in the post
operative visits for this service. Using
magnitude estimation, the AMA RUC
recommended the current work RVU of
12.37 for CPT code 60220. In
accordance with our methodology to
address 23-hour stay and site-of-service
anomalies described in III.A. of this
final rule with comment period, for CPT
code 60220, we removed the hospital
visit, reduced the discharge day
management service by one-half, and
adjusted times.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
11.19 for CPT code 60220 and believe
that that AMA RUC recommended work
RVU is more appropriate for this
service. Commenters noted that the
CMS value was derived from the reverse
building block methodology, which
removed the subsequent hospital care
code and reduced the full hospital
In the Fourth Five-Year Review, we
identified CPT codes 60220, 60240, and
60500 as potentially misvalued through
the sites-of-service anomaly screen. The
related specialty societies surveyed
these codes and the AMA RUC issued
recommendations to CMS for the Fourth
Five-Year Review of Work.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32453), for CPT
code 60220 (Total thyroid lobectomy,
unilateral; with or without
isthmusectomy), we proposed a work
RVU of 11.19 for CY 2012. Medicare
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ER28NO11.023</GPH>
the AMA RUC-recommended values for
these services.
Additionally, commenters disagreed
with the CMS decision to change the
post-partum visit building block from a
CPT code 99214 office visit to a CPT
code 99213 office visit. Commenters
noted that the post-partum visit
includes not only a post-procedure
physical exam, but also counseling and
screening. They reiterated that they
believe the CPT code 99214 office visit
best reflects the amount of services
provided by the physician at this visit.
Therefore, commenters requested that
CMS accept the AMA RUCrecommended values for all of the
obstetrical care services.
Response: We appreciate the specialty
society’s comprehensive application of
the building block methodology to value
the obstetrical care services and the
detailed rationale they provided. After
clinical review, we continue to believe
that CPT code 99213, rather than CPT
(22) Endocrine System: Thyroid Gland
(CPT Codes 60220–60240)
emcdonald on DSK4SPTVN1PROD with RULES2
Comment: Commenters disagreed
with the application of work budget
neutrality to this set of services and
noted that the specialty societies and
AMA RUC agreed that there was
compelling evidence that the work
RVUs for these services should be
increased. Commenters stated that the
original work RVUs for the obstetrical
care codes were established using a
flawed building block methodology, and
that discharge day management was not
accounted for. Commenters also stated
that the original building blocks that
were used to develop RVUs for the
obstetrical care codes included
evaluation and management codes, and
that the RVUs for these obstetrical care
codes had not been increased though
the evaluation and management codes
have had significant RVU increases in
the past 17 years. Based on these
arguments, commenters stated that work
budget neutrality should not be applied
to these codes, and urged CMS to accept
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73144
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
discharge day management code to a
half day. Commenters also stated that
our reverse building block methodology
is incorrect because Harvard did not use
RVU’s for E/M codes to build the
values-minutes were used. Commenters
recommended maintaining the current
work RVU of 12.37 for CPT code 60220.
Commenters also stated that the AMA
RUC-recommended physician time
should be restored.
Response: Based on the public
comments received, we referred CPT
60220 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVU was
12.37, which is consistent with the
AMA RUC recommendation to maintain
the current (CY 2011) work RVU for
CPT code 60220. The current (CY 2011)
work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this now outpatient
service to continue to reflect work that
is typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. Therefore, we are
finalizing a work RVU for CPT code
60220 of 11.19. In addition, after
reviewing the descriptions of the AMA
RUC-recommended time packages, we
disagree with the post-service time
recommended by the AMA RUC.
Therefore, we are finalizing a preservice time of 40 minutes, a pre-service
positioning time of 12 minutes, a preservice (dress, scrub, wait) time of 20
minutes, an intra-service time of 90
minutes, and a post-service time of 40
minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 60220. CMS time refinements can
be found in Table 16.
As detailed in the Fourth Five-Year
Review of Work (76 FR 32454), for CPT
code 60240 (Thyroidectomy, total or
complete), we proposed a work RVU of
15.04 for CY 2012. Medicare PFS claims
data indicated that CPT code 60240 is
typically furnished as an outpatient
rather than inpatient service. Using
magnitude estimation, the AMA RUC
believed the current work RVU of 16.22
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Jkt 226001
for CPT code 60240 was appropriate.
However, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 60240,
we removed the post-procedure
inpatient visit and reduced the
discharge day management service to
one-half. The AMA RUC recommended
maintaining the current work RVU of
16.22 for CPT code 60240.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
15.04 of CPT code 60240 and believe
that the AMA RUC-recommended work
RVU of 16.22 is more appropriate.
Additionally, commenters noted that
the CMS value was derived from the
reverse building block methodology,
which removed the post-procedure
inpatient visit and reduced the
discharge day management service to
one-half. Commenters also stated that
the AMA RUC originally valued this
service using magnitude estimation
based on comparison reference codes,
and requested that CMS accept the
AMA RUC-recommended work RVU of
16.22 for CPT code 60420. Commenters
also stated that the AMA RUCrecommended physician time should be
restored.
Response: Based on the public
comments received, we referred CPT
60240 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVU was
16.22, which was consistent with the
AMA RUC recommendation to maintain
the current (CY 2011) work RVU for
CPT code 60240. The current (CY 2011)
work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this service, which is
typically furnished on an outpatient
basis, to continue to reflect work that is
typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies finalized in the CY
2011 PFS final rule with comment
period (75 FR 73220). Therefore, we are
finalizing a work RVU for CPT code
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60240 of 15.04. In addition, after
reviewing the descriptions of the AMA
RUC-recommended time packages, we
disagree with the post-service time
recommended by the AMA RUC.
Therefore, we are finalizing a preservice time of 40 minutes, a pre-service
positioning time of 12 minutes, a preservice (dress, scrub, wait) time of 20
minutes, an intra-service time of 150
minutes, and a post-service time of 40
minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 60240. CMS time refinements can
be found in Table 16.
(23) Endocrine System: Parathyroid,
Thymus, Adrenal Glands, Pancreas, and
Cartoid Body (CPT Code 60500)
As detailed in the Fourth Five-Year
Review of Work (76 FR 32454), for CPT
code 60500 (Parathyroidectomy or
exploration of parathyroid(s)), we
proposed a work RVU of 15.60 for CY
2012. Medicare PFS claims data
indicated that CPT code 60500 is
typically furnished as an outpatient
rather than inpatient service. Using
magnitude estimation, the AMA RUC
believed the current work RVU of 16.78
for CPT code 60500 was appropriate.
Therefore, in accordance with our
methodology to address 23-hour stay
and site-of-service anomalies described
in section III.A. of this final rule with
comment period, for CPT code 60500,
we removed the hospital visit, reduced
the discharge day management service
by one-half, and adjusted times. The
AMA RUC recommended maintaining
the current work RVU of 16.78 for CPT
code 60500.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
15.60 for CPT code 60500 and believe
that the AMA RUC-recommended work
RVU of 16.78 is more appropriate.
Additionally, commenters noted that
the CMS value was derived from the
reverse building block methodology,
which removed the hospital visit and
reduced the discharge day management
service to one-half. Commenters also
stated that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, and requested that CMS
accept the AMA RUC recommended
work RVU of 16.78 for CPT code 60500.
Commenters also stated that the AMA
RUC recommended physician time
should be restored.
Response: Based on the public
comments received, we referred CPT
60500 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVU was
16.78, which was consistent with the
AMA RUC recommendation to maintain
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the current (CY 2011) work RVU for
CPT code 60500. The current (CY 2011)
work RVU for this service was
developed when this service was
typically furnished in the inpatient
setting. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, the AMA RUCrecommendation and refinement panel
results do not reflect a decrease in
physician work. We do not believe it is
appropriate for this service, which is
typically furnished on an outpatient
basis, to continue to reflect work that is
typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology described
previously to address 23-hour stay siteof-service anomalies. Therefore, we are
finalizing a work RVU for CPT code
60500 of 15.60. In addition, after
reviewing the descriptions of the AMA
RUC-recommended time packages, we
disagree with the post-service time
recommended by the AMA RUC.
Therefore, we are finalizing a preservice time of 40 minutes, a pre-service
positioning time of 12 minutes, a preservice (dress, scrub, wait) time of 20
minutes, an intra-service time of 120
minutes, and a post-service time of 40
minutes. We are also reducing the
hospital discharge day by 0.5 for CPT
code 60500. CMS time refinements can
be found in Table 16.
(24) Nervous System: Skull, Meninges,
Brain and Extracranial Peripheral
Nerves, and Autonomic Nervous System
(CPT Codes 61781–61885, 64405–
64831)
We discussed CPT code 61885
(Insertion or replacement of cranial
neurostimulator pulse generator or
receiver, direct or inductive coupling;
with connection to a single electrode
array) in the CY 2011 final rule with
comment period (75 FR 73332) where
we noted that this code was identified
as a site-of-service anomaly code in
September 2007. After reviewing the
vagal nerve stimulator family of
services, the specialty societies agreed
that the family lacked clarity and the
CPT Editorial Panel created three new
codes to accurately describe revision of
a vagal nerve stimulator lead, the
placement of the pulse generator and
replacement or revision of the vagus
nerve electrode. For CY 2011, the AMA
RUC recommended a work RVU of 6.44
for CPT code 61885. Although the AMA
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RUC compared this service to the key
reference service, CPT code 63685
(Insertion or replacement of spinal
neurostimulator pulse generator or
receiver, direct or inductive coupling)
(work RVUs = 6.05) and other relative
services and noted the similarities in
times, the AMA RUC elected not to
recommend this value of 6.05 for CPT
code 61885. We believed the AMA RUCrecommended work RVUs did not
adequately account for the elimination
of two inpatient visits and the reduction
in outpatient visits for this service. We
disagreed with the AMA RUC
recommended value and believed 6.05
work RVUs, the survey 25th percentile,
was appropriate for this service.
Therefore, we assigned an alternative
value of 6.05 work RVUs to CPT code
61885 on an interim final basis for CY
2011.
Comment: Commenters stated that
assumptions by CMS that the RUC
recommendations did not adequately
account for the elimination of two
inpatient visits and the reduction in
outpatient visits for this service is
flawed. Furthermore, the commenters
asserted that the rationale in the RUC
database indicates that the initial RUC
recommended value for this code
included a reduction in value due to an
adjustment of the post-operative E/M
visits. Commenters recommended we
accept the AMA RUC-recommended
work RVU of 6.44 for CPT code 61885.
Response: Based on the comments
received, we referred CPT code 61885 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 6.44,
which was consistent with the AMA
RUC-recommendation to maintain the
current work RVU for this service. We
believe that the AMA RUCrecommended work RVUs did not
adequately account for the elimination
of two inpatient visits and the reduction
in outpatient visits for this service. We
believe that 6.05 work RVUs, the survey
25th percentile, is appropriate for this
service. Therefore, we are finalizing a
work RVU of 6.05 for CPT code 61885
in CY 2012.
In the Fourth Five-Year Review (76
FR 32455), CMS identified CPT code
64405 as potentially misvalued through
the Harvard-Valued—Utilization >
30,000 screen. As detailed in the Fourth
Five-Year Review of Work, for CPT code
64405 ((Injection, anesthetic agent;
greater occipital nerve), we proposed a
work RVU of 0.94 for CY 2012. The
AMA RUC reviewed the survey results
and recommended the median survey
work RVU of 1.00 for CPT code 64405.
We disagreed with the AMA RUCrecommended work RVU for CPT code
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73145
64405. Upon clinical review and a
consideration of physician time and
intensity, we believed this code is
comparable to the key reference CPT
code 20526 (Injection, therapeutic (e.g.,
local anesthetic, corticosteroid), carpal
tunnel) (work RVU = 0.94).
Comment: Commenters disagreed
with the CMS-proposed work RVU of
0.94 of CPT code 64405 and believe that
the AMA RUC-recommended work RVU
of 1.00 is more appropriate. The
commenters noted survey findings
stating that 97 percent of the
respondents agreed that the vignette
described the typical patient for this
service. Furthermore, the commenters
stated that CMS does not provide any
rationale explaining use of CPT code
20526 as a comparison over the AMA
RUC vignette and survey results.
Commenters believed that CMS should
give more consideration to the survey
results when valuing an occipital nerve
block.
Response: Based on the public
comments received, we referred CPT
64405 to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVU
supported the AMA RUC-recommended
work RVU of 1.00 for CPT code 64405.
We believe that the comparison to CPT
code 20526 is appropriate for this
service and related work RVUs.
Therefore, we are finalizing a work RVU
of 0.94 for CPT code 64405.
For CPT code 64568 (Incision for
implantation of cranial nerve (e.g.,
vagus nerve) neurostimulator electrode
array and pulse generator), the AMA
RUC recommended 11.19 work RVUs;
however, the methodology was unclear.
As with CPT code 61885 discussed
previously, to which this code is
related, we conducted a clinical review
and compared the physician intensity
and time associated with providing this
service and determined that the survey
25th percentile, 9.00 work RVUs, was
appropriate. Therefore, we assigned an
alternative value of 9.00 work RVUs to
CPT code 64568 on an interim final
basis for CY 2011 (75 FR 73332).
In the CY 2011 PFS final rule with
comment period (75 FR 73332), for CPT
codes 64569 (Revision or replacement of
cranial nerve (e.g., vagus nerve)
neurostimulator electrode array,
including connection to existing pulse
generator) and 64570 (Removal of
cranial nerve (e.g., vagus nerve)
neurostimulator electrode array and
pulse generator), we assigned interim
final work RVUs of 11.00 and 9.10,
respectively, for CY 2011. In section
II.B.3. of this final rule with comment
period, we described maintaining
relativity for the codes in families as a
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priority in the review of misvalued
codes. Based on the reduction in work
RVUs for CPT codes 61885 and 64568
that we adopted on an interim final
basis for CY 2011, we believed work
RVUs of 11.00, the survey 25th
percentile, were appropriate for CPT
code 64569 and work RVUs of 9.10, the
survey 25th percentile, were appropriate
for CPT code 64570. Therefore, we
assigned alternative work RVUs of 11.00
to CPT code 64569 and 9.10 to CPT code
64570 on an interim final basis for CY
2011.
Comment: Commenters noted that
CMS makes its interim
recommendations based on the selection
of a reference code which has similar
time and intensity. Additionally,
commenters asserted that CMS does not
offer any reference codes to support the
proposed interim values for any of these
services. Moreover, the commenters
disagreed with CMS’s interim final
values for 64568, 64569, and 64570,
which were based on CMS’ rationale to
support the valuation of 61885, a siteof-service anomaly code. The
commenters requested that CMS accept
the AMA RUC-recommended values of
11.19 for CPT code 64568.
Response: Based on the comments
received, we referred CPT code 64568,
64569, and 64570 to the CY 2011 multispecialty refinement panel for further
review. Although the refinement panel
median work RVUs were 11.47 for CPT
code 64568, 15.00 for CPT code 64569,
and 13.00 for 64570, we believe it is
imperative to maintain appropriate
relativity within the code family as well
as across code families in order to
ensure accuracy in the entire PFS
system. Accordingly, to maintain
appropriate relativity with CPT code
61885, we are finalizing the following
work RVUs for CY 2012: 9.00 for CPT
code 64568, 11.00 for CPT code 64569
and 9.10 for CPT code 64570.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 61781, 61782,
61783, 64415, 64445, 64447, 64479,
64480, 64484, 64566, 64581, 64611,
64708, 64712, 64713, and 64714. We
believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
Finally, we received no public
comments on the CY 2012 proposed
work RVUs for CPT codes 64831 and
64708. We believe these values continue
to be appropriate and are finalizing
them without modification (Table 15).
(25) Nervous System: Spine and Spinal
Cord (CPT Codes 62263–63685)
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42800), CPT code
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62263 (Percutaneous lysis of epidural
adhesions using solution injection (e.g.,
hypertonic saline, enzyme) or
mechanical means (e.g., catheter)
including radiologic localization
(includes contrast when administered),
multiple adhesiolysis sessions; 2 or
more days), was identified for CY 2009
as potentially misvalued through the
site-of-service anomaly screen. We
referred this code back to the AMA RUC
for review because of our ongoing
concern that the AMA RUC did not
believe the AMA RUC appropriately
accounted for the change in site-ofservice when providing the
recommendation for work RVUs. That
is, for CY 2009, the AMA reviewed
survey data, compared this code to other
services, and concluded that while it
was appropriate to remove the inpatient
subsequent hospital care visits to reflect
the current outpatient place of service,
the AMA RUC recommended
maintaining the CY 2008 work RVU for
this service. We disagreed with the
AMA RUC’s methodology because we
believe the appropriate methodology for
valuing site-of-service anomaly codes
entails not just removing the inpatient
visits, but also accounting for the
removal of the inpatient visits in the
work value of the CPT code.
Accordingly, while we accepted the
AMA RUC-recommended work RVU for
this code on an interim basis for CYs
2009 and 2010 (with a slight adjustment
in CY 2010 due to the consultation code
policy (74 FR 61775)), we referred the
code back to the AMA RUC to be
reexamined.
Upon re-review for CY 2012, the AMA
RUC reaffirmed its previous
recommendation and recommended that
the current work RVU of 6.54 for CPT
code 62263 be maintained. In the CY
2012 PFS proposed rule (76 FR 42800),
we indicated that we continue to
disagreed with the AMA RUC
recommended work RVU for this service
because we believe the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. We
noted also that the AMA RUC
disregarded survey results that
indicated the respondents believed this
service should be valued lower. In fact,
the median survey work RVU was 5.00.
After CMS clinical review of this service
where we considered this code in
comparison to other codes in the PFS
and accounted for the change in the siteof-service, we believed that the survey
median work RVU of 5.00 appropriately
accounted for the removal of the
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inpatient visits. Therefore, we proposed
a work RVU of 5.00 for CPT code 62263
for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 62263 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 6.02. We
do not believe that either the AMA RUC
recommended work RVU or the
refinement panel result adequately
accounts for the removal of all the
inpatient visits for this service which
was originally identified as having a
site-of-service anomaly. As we specified
previously, we believe the appropriate
methodology for valuing site-of-service
anomaly codes entails both removing
the inpatient visits and modifying the
work RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
5.00 for CPT code 62263 with
refinements to time. CMS time
refinements can be found in Table 16.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42800), CPT code
62355 (Removal of previously
implanted intrathecal or epidural
catheter) was identified as potentially
misvalued through the site-of-service
anomaly screen for CY 2009. The AMA
RUC reviewed this service and
recommended a work RVU of 4.30,
approximately midway between the
survey median and 75th percentile. The
AMA RUC also recommended removing
the inpatient building blocks to reflect
the outpatient site-of-service, removing
all but 1 of the post-procedure office
visits to reflect the shift in global period
from 90 days to 10 days, and reducing
the physician time associated with this
service. While we accepted the AMA
RUC-recommended work RVU for this
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code on an interim basis for CYs 2009
and 2010 (with a slight adjustment in
CY 2010 due to the consultation code
policy (74 FR 61775)), we referred the
code back to the AMA RUC to be
reexamined because we did not believe
the AMA RUC-recommended work RVU
fully accounted for the reduction in
inpatient building blocks to reflect the
shift to the outpatient setting.
Upon re-review for CY 2012, the AMA
RUC reaffirmed its previous
recommendation and ultimately
recommended that the current work
RVU of 4.35 for CPT code 62355 be
maintained. We disagreed with the
AMA RUC-recommended work RVU for
CPT code 62355. As stated previously,
we believed the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. We did
not believe that the reduction from the
CY 2008 work RVU of 6.60 to the CY
2009 work RVU of 4.30 adequately
accounted for the removal of 3
subsequent hospital care visits and half
a discharge management day, which
together represent a work RVU of 5.40.
Also, the time required to furnish this
service dropped significantly, even after
considering the global period change.
Upon clinical review, we believed that
the survey median work RVU of 3.55
appropriately accounted for the removal
of the inpatient visits and decreased
time for this service. Therefore,
proposed a work RVU of 3.55 for CPT
code 62355 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 62355 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 4.18. The
AMA RUC recommended maintain the
current (CY 2011) work RVU of 4.35 for
CPT code 62355. While the AMA RUC
reduced the RVUs for CY 2009, we do
not believe the AMA RUCrecommended value adequately
accounted for the shift from inpatient to
outpatient and the reduction in office/
outpatient visits. That is, we do not
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believe that either the AMA RUC
recommended work RVU or the
refinement panel result adequately
accounts for the removal of all the
inpatient visits for this service which
was originally identified as having a
site-of-service anomaly. As we specified
previously, we believe the appropriate
methodology for valuing site-of-service
anomaly codes entails both removing
the inpatient visits and modifying the
work RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
3.55 for CPT code 62355.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42800), CPT code
62361 (Implantation or replacement of
device for intrathecal or epidural drug
infusion; nonprogrammable pump) was
identified for CY 2009 as potentially
misvalued through the site-of-service
anomaly screen. The AMA RUC
reviewed this code and recommended a
work RVU of 5.60, approximately
midway between the survey median and
75th percentile. The AMA RUC also
recommended removing the inpatient
visits to reflect the outpatient site-ofservice, removing all but 1 of the post
procedure office visits to reflect the shift
in global period from 90 days to 10
days, and reducing the physician time
associated with this service. While we
accepted the AMA RUC’s recommended
work RVU for this code on an interim
basis for CYs 2009 and 2010 (with a
slight adjustment to 5.65 work RVUs in
CY 2010 due to the consultation code
policy (74 FR 61775)), we referred the
code back to the AMA RUC to be
reexamined because we did not believe
the AMA RUC recommended work RVU
fully accounted for the reduction in
inpatient building blocks to reflect the
shift to the outpatient setting.
Upon re-review for CY 2012, the AMA
RUC reaffirmed its previous
recommendation and ultimately
recommended that the work RVU of
5.65 for CPT code 62361 be maintained.
We disagreed with the AMA RUCrecommended work RVU for CPT code
62361. As stated previously, we believe
the appropriate methodology for valuing
site-of-service anomaly codes entails not
just removing the inpatient visits, but
also accounting for the removal of the
inpatient visits in the work value of the
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CPT code. We did not believe that the
reduction from the CY 2008 work RVU
of 6.59 to the CY 2009 work RVU of 5.60
adequately accounted for the removal of
3 subsequent hospital care visits and
half a discharge management day,
which together represent a work RVU of
5.40. Also, the time required to furnish
this service dropped significantly, even
after considering the global period
change. Upon clinical review, we
believed that the survey 25th percentile
work RVU of 5.00 appropriately
accounted for the removal of the
inpatient visits and decreased time for
this service. Therefore, we proposed a
work RVU of 5.00 for CPT code 62361
for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 62361 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 5.48. The
AMA RUC recommended maintaining
the current work RVU of 5.65 for CPT
code 62361. We do not believe that
either the AMA RUC recommended
work RVU or the refinement panel
result adequately accounts for the
removal of all the inpatient visits for
this service which was originally
identified as having a site-of-service
anomaly. As we specified previously,
we believe the appropriate methodology
for valuing site-of-service anomaly
codes entails both removing the
inpatient visits and modifying the work
RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
5.00 for CPT code 62361.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42800), CPT code
62362 (Implantation or replacement of
device for intrathecal or epidural drug
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infusion; programmable pump,
including preparation of pump, with or
without programming) was identified
for CY 2009 as potentially misvalued
through the site-of-service anomaly
screen. The AMA RUC reviewed the
code and recommended a work RVU of
6.05, approximately midway between
the survey median and 75th percentile.
The AMA RUC also recommended
removing the inpatient visits to reflect
the outpatient site-of-service, removing
all but 1 of the post procedure office
visits to reflect the shift in global period
from 90 days to 10 days, and reducing
the physician time associated with this
service. While we accepted the AMA
RUC’s recommended work RVU for this
code on an interim basis for CYs 2009
and 2010 (with a slight adjustment to
6.10 work RVUs in CY 2010 due to the
consultation code policy (74 FR 61775)),
we referred the code back to the AMA
RUC to be reexamined because we did
not believe the AMA RUCrecommended work RVU fully
accounted for the reduction in inpatient
building blocks to reflect the shift to the
outpatient setting. Upon re-review for
CY 2012, the AMA RUC reaffirmed its
previous recommendation and
ultimately recommended that the
current work RVU of 6.10 for CPT code
62362 be maintained. We disagree with
the AMA RUC-recommended work RVU
for CPT code 62362. As stated
previously, we believed the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. We do
not believe that the reduction from the
CY 2008 work RVU of 8.58 to the CY
2009 work RVU of 6.05 adequately
accounts for the removal of 3
subsequent hospital care visits and half
a discharge management day, which
together represent a work RVU of 5.40.
Also, the time required to furnish this
service dropped significantly, even after
considering the global period change.
Upon clinical review, we believed that
the survey median work RVU of 5.60
appropriately accounted for the removal
of the inpatient visits and decreased
time for this service. Therefore, we
proposed a work RVU of 5.60 for CPT
code 62362 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
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total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 62362 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 5.95. The
AMA RUC recommended maintaining
the current work RVU of 6.10 for CPT
code 62362. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not
adequately reflect a decrease in
physician work. We do not believe that
either the AMA RUC recommended
work RVU or the refinement panel
result adequately accounts for the
removal of all the inpatient visits for
this service which was originally
identified as having a site-of-service
anomaly. As we specified previously,
we believe the appropriate methodology
for valuing site-of-service anomaly
codes entails both removing the
inpatient visits and modifying the work
RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
5.60 for CPT code 62362.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42801), CPT code
62365 (Removal of subcutaneous
reservoir or pump, previously
implanted for intrathecal or epidural
infusion) was identified for CY 2009 as
potentially misvalued through the siteof-service anomaly screen. The AMA
RUC reviewed this service and
recommended a work RVU of 4.60, the
survey median. Additionally, the AMA
RUC recommended removing the
inpatient visits to reflect the outpatient
site-of-service, removing all but 1 of the
post-procedure office visits to reflect the
shift in global period from 90 days to 10
days, and reducing the physician time
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Sfmt 4700
associated with this service. While we
accepted the AMA RUC’s recommended
work RVU for this code on an interim
basis for CYs 2009 and 2010 (with a
slight adjustment to 4.65 work RVUs in
CY 2010 due to the consultation code
policy (74 FR 61775)), we referred the
code back to the AMA RUC to be
reexamined because we did not believe
the AMA RUC-recommended work RVU
fully accounted for the reduction in
inpatient building blocks to reflect the
shift to the outpatient setting.
Upon re-review for CY 2012, the AMA
RUC reaffirmed its previous
recommendation and ultimately
recommended that the current work
RVU of 4.65 for CPT code 62365 be
maintained. We disagreed with the
AMA RUC recommended work RVU for
CPT code 62365. As stated previously,
we believed the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. We did
not believe that the reduction from the
CY 2008 work RVU of 6.57 to the CY
2009 work RVU of 4.60 adequately
accounted for the removal of 3
subsequent hospital care visits and half
a discharge management day, which
together represent a work RVU of 5.40.
Also, the time required to furnish this
service dropped significantly, even after
considering the global period change.
We believed that this service is similar
in terms of time intensity to that of CPT
code 33241 (Subcutaneous removal of
single or dual chamber pacing
cardioverter-defibrillator pulse
generator) which has a work RVU of
3.29 but does not include a half day of
discharge management service. Upon
clinical review, we believed that a work
RVU of 3.93, that is a work RVU of 3.29
plus a work RVU of 0.64 to account for
the half day of discharge management
service, appropriately accounted for the
removal of the inpatient visits and
decreased time for this service.
Therefore, we proposed a work RVU of
3.93 for CPT code 62365 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
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Response: Based on comments
received, we referred CPT code 62365 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 4.40. The
AMA RUC recommended maintaining
the current work RVU of 4.65 for CPT
code 62365. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not
adequately reflect a decrease in
physician work. We do not believe that
either the AMA RUC recommended
work RVU or the refinement panel
result adequately accounts for the
removal of all the inpatient visits for
this service which was originally
identified as having a site-of-service
anomaly. As we specified previously,
we believe the appropriate methodology
for valuing site-of-service anomaly
codes entails both removing the
inpatient visits and modifying the work
RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
3.93 for CPT code 62365.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42802), CPT code
63650 (Percutaneous implantation of
neurostimulator electrode array,
epidural) or mechanical means (such as,
catheter) including radiologic
localization (includes contrast when
administered), multiple adhesiolysis
sessions; 2 or more days, was identified
for CY 2009 as potentially misvalued
through the site-of-service anomaly
screen. The AMA RUC reviewed this
service and recommended the survey
median work RVU of 7.15 as well as
removing the inpatient subsequent
hospital care visits to reflect the current
outpatient place of service. While we
accepted the AMA RUC’s recommended
work RVU for this code on an interim
basis for CYs 2009 and 2010 (with a
slight adjustment to 7.20 work RVUs in
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CY 2010 due to the consultation code
policy (74 FR 61775)), we referred the
code back to the AMA RUC to be
reexamined because we did not believe
the AMA RUC-recommended work RVU
fully accounted for the reduction in
inpatient building blocks to reflect the
shift to the outpatient setting.
Upon re-review for CY 2012, the AMA
RUC reaffirmed its previous
recommendation and ultimately
recommended that the current work
RVU of 7.20 for CPT code 63650 be
maintained. We disagreed with the
AMA RUC-recommended work RVU of
7.20 for CPT code 63650. As stated
previously, we believed the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. Upon
clinical review, we believed that the
survey median work RVU of 7.15
appropriately accounted for the removal
of the inpatient visits, as well as the
physician time and post-operative office
visit changes. Therefore, we proposed a
work RVU of 7.15 for CPT code 63650
for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 63650 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 7.18. The
AMA RUC recommended maintaining
the current work RVU of 7.20 for CPT
code 63650. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not
adequately reflect a decrease in
physician work. That is, we do not
believe that either the AMA RUC
recommended work RVU or the
refinement panel result adequately
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73149
accounts for the removal of all the
inpatient visits for this service which
was originally identified as having a
site-of-service anomaly. As we specified
previously, we believe the appropriate
methodology for valuing site-of-service
anomaly codes entails both removing
the inpatient visits and modifying the
work RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
7.15 for CPT code 63650.
As discussed in the Fourth Five-Year
Review of Work (76 FR 32454), CMS
identified CPT code 63655
(Laminectomy for implantation of
neurostimulator electrodes, plate/
paddle, epidural) as potentially
misvalued through the Site-of-Service
Anomaly screen. The AMA RUC
recommended maintaining the current
work RVU of 11.56, as well as the
current physician time components. We
disagreed with the AMA RUCrecommended work RVU for CPT code
63655. We noted that according to the
survey data provided by the AMA RUC,
of the 90 percent of respondents that
stated they furnish the procedure ‘‘in
the hospital,’’ 18 percent stated that the
patient is ‘‘discharged the same day’’
and 55 percent stated that the patient
was ‘‘kept overnight (less than 24
hours).’’ Given that the most recently
available Medicare PFS claims data
continue to show the typical case is not
an inpatient, and that the survey data
for this code suggested the typical case
is a 23-hour stay service, we believed it
was appropriate to apply our
established policy and reduce the
discharge day management service to
one-half. Accordingly, we proposed an
alternative work RVU of 10.92 with
refinements in time for CPT code 63655
for CY 2012.
Comment: Commenters disagreed
with the CMS proposed work RVU of
10.92 for CPT code 63655 and believed
that the AMA RUC recommended work
RVU of 11.56 was more appropriate.
Commenters believed that there was no
evidence that the work of this
procedure, which includes a full
laminectomy, has changed since April
2009. In addition, commenters noted
that complete 2008 Medicare utilization
data shows that 63655 was billed 51.2
percent in the inpatient hospital setting,
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questioning whether it was appropriate
for this service to be on the ‘‘site of
service’’ change list at all since it was
so close to 50 percent, the threshold
which defines ‘‘typical.’’
Response: Based on the public
comments received, we referred CPT
63655 to the CY 2011 Multi-Specialty
Refinement Panel for further review.
The refinement panel median work RVU
was 11.56, which was consistent with
the the AMA RUC recommendation to
maintain the current work RVU for CPT
code 63655. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not
adequately reflect a decrease in
physician work. We do not believe it is
appropriate for this service, which is
typically furnished on an outpatient
basis, to continue to reflect work that is
typically associated with an inpatient
service. We note that 50 percent defines
‘‘typical’’ for purposes of valuing
services under the PFS. In order to
ensure consistent and appropriate
valuation of physician work, we believe
it is appropriate to apply our
methodology described previously to
address 23-hour stay site-of-service
anomalies. Therefore, we are finalizing
a work RVU for CPT code 63655 of
10.92 for CY 2012. We are also
finalizing the proposed refinements to
time. CMS time refinements can be
found in Table 16.
As we discussed in the CY 2012 PFS
proposed rule (76 FR 42802), CPT code
63685 (Insertion or replacement of
spinal neurostimulator pulse generator
or receiver, direct or inductive coupling)
was identified for CY 2009 as
potentially misvalued through the siteof-service anomaly screen. The AMA
RUC reviewed this service and
recommended the survey median work
RVU of 6.00. The AMA RUC also
recommended removing the inpatient
subsequent hospital care visits to reflect
the current outpatient place of service.
While we accepted the AMA RUC’s
recommended work RVU for this code
on an interim basis for CYs 2009 and
2010 (with a slight adjustment to the
work RVUs in CY 2010 due to the
consultation code policy (74 FR 61775)),
we referred the code back to the AMA
RUC to be reexamined because we did
not believe the AMA RUC-
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recommended work RVU fully
accounted for the reduction in inpatient
building blocks to reflect the shift to the
outpatient setting.
Upon re-review for CY 2012, the AMA
RUC affirmed its previous
recommendation and ultimately
recommended that the current work
RVU for CPT code 63685 be maintained.
We disagreed with the AMA RUCrecommended work RVU of 6.05 for
CPT code 63685. As stated previously,
we believed the appropriate
methodology for valuing site-of-service
anomaly codes entails not just removing
the inpatient visits, but also accounting
for the removal of the inpatient visits in
the work value of the CPT code. Upon
clinical review, we believed that the
survey 25th percentile work RVU of
5.19 appropriately accounted for the
removal of the inpatient visits, as well
as the physician time and post-operative
office visit changes. Therefore, we
proposed a work RVU of 5.19 for CPT
code 63685 for CY 2012.
Comment: Commenters disagreed
with CMS’ proposed work RVU, stating
that they remained concerned that CMS
still assumes that the starting values for
these services were correct. Commenters
noted that the AMA RUC originally
valued this service using magnitude
estimation based on comparison
reference codes, which considers the
total work of the service rather than the
work of the component parts of the
service, and requested CMS accept the
AMA RUC-recommended work RVU
and physician time.
Response: Based on comments
received, we referred CPT code 63685 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 5.78. The
AMA RUC recommended maintaining
the current work RVU of 6.05 for CPT
code 63685. The current (CY 2011) work
RVU for this service was developed
when this service was typically
furnished in the inpatient setting. As
this service is now typically furnished
in the outpatient setting, we believe that
it is reasonable to expect that there have
been changes in medical practice for
these services, and that such changes
would represent a decrease in physician
time or intensity or both. However, the
AMA RUC-recommendation and
refinement panel results do not
adequately reflect a decrease in
physician work. That is, we do not
believe that either the AMA RUC
recommended work RVU or the
refinement panel result adequately
accounts for the removal of all the
inpatient visits for this service which
was originally identified as having a
site-of-service anomaly. As we specified
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previously, we believe the appropriate
methodology for valuing site-of-service
anomaly codes entails both removing
the inpatient visits and modifying the
work RVU to adequately account for the
removal of all the inpatient visits
originally included. In order to ensure
consistent and appropriate valuation of
physician work, we believe it is
appropriate to apply our methodology to
address codes with site-of-service
anomalies as discussed in detail in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
assigning a work RVU for CY 2012 of
5.19 for CPT code 63685.
We received no public comments on
the CY 2011 final rule with comment
period interim work RVUs for CPT
codes 63075 and 63076. We received no
public comments on the Fourth FiveYear Review of Work proposed work
RVUs for CPT code 62284. Finally, we
also received no public comments on
the CY 2012 PFS proposed rule
proposed work RVUs for CPT codes
62360 and 62350. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
(26) Eye and Ocular Adnexa: Eyeball
(CPT Codes 65285)
As detailed in the CY 2012 PFS
proposed rule (76 FR 42802), we
identified CPT code 65285 (Repair of
laceration; cornea and/orsclera,
perforating, with reposition or resection
of uveal tissue) as a potentially
misvalued code through the site-ofservice anomaly screen in 2009. The
AMA RUC recommended removing the
CPT code from the site-of-service
anomaly list and maintaining the CY
2008 work RVUs (14.43), physician
times, and visits. In the CY 2010 PFS
final rule with comment period, while
we adopted the AMA RUCrecommended work value on an interim
final basis and referred the service back
to the AMA RUC to be reexamined, the
work RVU for CPT code 65285 used
under the PFS was increased to 14.71
based on the redistribution of RVUs that
resulted from the our policy to no longer
recognize the CPT consultation codes
(74 FR 61775).
In the CY 2012 PFS proposed rule (76
FR 42802), we proposed to apply the 23hour stay methodology described in
section III.A. of this final rule with
comment period. That is, we reduced
the one day of discharge management
service to one-half day, and adjusted
physician work RVUs and times
accordingly. As a result, we proposed a
work RVU of 15.36 with refinements to
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the time for CPT code 65285 for CY
2012. CMS time refinements can be
found in Table 16. The AMA RUC
recommended a work RVU of 16.00 for
CPT code 65285 for CY 2012.
Comment: Commenters disagreed
with the CMS proposed work RVU of
15.36, and requested that CMS accept
the AMA RUC-recommended work RVU
of 16.00 for CPT code 65285.
Commenters stated that the AMA RUCrecommended RVU was more
appropriate because the intensity of and
complexity of the procedure has
increased due to enhanced
microsurgical technology,
improvements in suture and graft
materials and new pharmaceuticals that
control post operative complications.
Commenters also disagreed with
applying the site-of-service
methodology of reducing the discharge
management service to one-half day
when the AMA RUC’s valuation was not
based on a building block methodology.
Response: Based on the comments we
received, we referred CPT code 65285 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 16.00,
which was consistent with the AMA
RUC recommendation. The AMA RUCrecommended work value for this
service included a full discharge day
management service, which we do not
believe is appropriate for an outpatient
service. As this service is now typically
furnished in the outpatient setting, we
believe that it is reasonable to expect
that there have been changes in medical
practice for these services, and that such
changes would represent a decrease in
physician time or intensity or both.
However, we do not believe the AMA
RUC-recommendation and refinement
panel results adequately reflect a
decrease in physician work. We do not
believe it is appropriate for this service
to continue to reflect work that is
typically associated with an inpatient
service. In order to ensure consistent
and appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology to address siteof-service anomalies as discussed in
section III.A. of this final rule with
comment period. After consideration of
the public comments, refinement panel
results, and our clinical review, we are
finalizing a work RVU of 15.36, with
time refinements, for CPT code 65285.
For CY 2012, we receive no public
comments on the CY 2011 interim final
work RVUs for CPT codes 65778
through 65780, 66174, 66175, and
66761. We believe these values continue
to be appropriate and are finalizing
them without modification (Table 15).
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(27) Eye and Ocular Adnexa: Posterior
Segment (CPT Code 67028)
CPT code 67028 (Intravitreal injection
of a pharmacologic agent (separate
procedure) was identified for review by
the Five-Year Identification Workgroup
through the High Volume CMS Fastest
Growing Screen. For CY 2011, the AMA
RUC reviewed the survey results,
compared the code to other services,
and concluded that CPT code 67028 was
similar in both physician time and
intensity to another eye injection code,
CPT code 67500 (retrobulbar injection:
Medication). Accordingly, the AMA
RUC recommended accepting the
specialty society recommended time
and directly crosswalking the work
RVUs of CPT code 67500 of 1.44 to CPT
code 67028. Upon clinical review, we
agreed that these two services are
similar and therefore assigned a CY
2011 interim final work RVU of 1.44 to
CPT code 67028 (75 FR 73732).
Comment: Commenters strongly
disputed the AMA RUC-recommended
work RVU for CPT code 67028 that CMS
accepted as the interim final value for
CY 2011. Commenters asserted that a
comparison of CPT code 67028 to CPT
code 67500 shows that the AMA RUC
significantly underestimated the
physician work of CPT code 67028.
Commenters believed that injecting
medication directly into the vitreous of
the eye is more intense, carries more
risk, requires more training and is
inherently more stressful than injecting
medication around the external areas of
the eye and that this difference should
be recognized in a relative value system
with a higher physician work value. The
commenters requested this code be
discussed at the CY 2011 refinement
panel and recommended a value of 2.12
work RVUs be finalized for CPT code
67028, instead of the interim final value
of 1.44.
Response: Based on comments
received, we referred CPT code 67028 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 1.96.
Upon clinical review, we believe that
the physician work of CPT code 67028
is similar to that of CPT code 67500. We
find it compelling that the specialtyrecommended time for this code is
similar to the reference code and that
the AMA RUC has also concluded that
the services are similar in both time and
intensity. Accordingly, we are assigning
final work RVU of 1.44 to CPT code
67028 for CPT code 67028.
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(28) Diagnostic Radiology: Chest, Spine,
and Pelvis (CPT Codes 71250, 72100,
72110, 72120, 72125, 72128, 72131,
72144, and 72170)
As we discussed in the CY 2011 final
rule with comment period (75 FR
73340), CPT Code 71250 (Computed
tomography, thorax; without contrast
material) was identified as a potentially
misvalued code by the Five-Year
Review Identification Workgroup under
the ‘‘CMS Fastest Growing’’ potentially
misvalued codes screen. While the
AMA RUC recommended the survey
results for physician times, the AMA
RUC believed maintaining the code’s
current value of 1.16 work RVUs was
more appropriate, noting that this
recommended value is slightly lower
than the survey 25th percentile of 1.20.
We disagreed with the AMA RUC’s CY
2011 work RVU recommendation to
maintain the current value for CPT code
71250 and similar codes. As we noted
in the CY 2011 final rule with comment
period (75 FR 73340), we were
increasingly concerned over the validity
of accepting work valuations based
upon surveys conducted on existing
codes as we have noticed a pattern of
predictable survey results. Increasingly,
rather than recommending the median
survey value that has historically been
most commonly used, the AMA RUC
has been choosing to recommend the
25th percentile value, potentially
responding to the same concern we have
identified. Therefore, based on our
concern that CT codes would continue
to be misvalued if we were to accept the
AMA RUC recommendation to maintain
the current value, we assigned an
alternative value of 1.00 work RVUs (the
survey low value) to CPT code 71250 on
an interim final basis for CY 2011.
Also in the CY 2011 final rule with
comment period (75 FR 73341), we
noted CPT codes 72125 (Computed
tomography, cervical spine; without
contrast material), 72128 (Computed
tomography, thoracic spine; without
contrast material), and 72131
(Computed tomography, lumbar spine;
without contrast material) were also
identified as potentially misvalued
codes by the Five-Year Review
Workgroup under the ‘‘CMS Fastest
Growing’’ screen for potentially
misvalued codes. For CPT code 72125,
the AMA RUC concurred with the
specialty-recommended times but
concluded that it was appropriate to
maintain the current work RVUs of 1.16.
Similarly, for CPT codes 72128 and
72131, the AMA RUC accepted the
survey physician times, but also
disregarded the median survey work
RVU results in favor of recommending
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maintaining the current values. Upon
clinical review of these codes in this
family, we were concerned over the
validity of the survey results since the
survey 25th percentile values are very
close to the current value of 1.16 RVUs
for the code. As we stated previously,
we were concerned that this pattern
may indicate a bias in the survey
results. Therefore, based on our concern
that the CT codes would continue to be
misvalued if we were to accept the
AMA RUC recommendation to maintain
the current values, we assigned
alternative work RVUs of 1.00 (the
survey low value) to CPT codes 72125,
72128, and 72131 on an interim final
basis for CY 2011.
Comment: Commenters acknowledged
that the existing RVUs are available
within the public domain and are
accessible on the CMS Web site,
however, the commenters doubted this
influenced the RVU choices among the
respondents. The commenters noted
that the survey respondents are
provided with reference codes to which
they may compare services in order to
maintain relativity within the system.
Furthermore, some commenters noted
that ‘‘other data used by the RUC to
validate the RVUs chosen by most
respondents, such as the existing service
period times and those of the reference
services, are not readily available to the
respondents and the RUC methodology
of evaluating survey results is even less
accessible.’’ Thus, commenters ‘‘believe
CMS’ conclusion that bias was
interjected into the survey process is
unwarranted.’’ The commenters
requested CMS accept the AMA RUC
recommended work RVU instead.
Response: Based on comments
received, we referred CPT codes 71250,
72125, 72128, and 72131 to the CY 2011
multi-specialty refinement panel for
further review. The refinement panel
median work RVUs were 1.02 for CPT
code 71250, 1.07 for CPT code 72125,
1.00 for CPT code 72128, and 1.00 for
CPT code 72131. As a result of the
refinement panel ratings and clinical
review by CMS, we are assigning CY
2012 final work RVU of 1.02 to CPT
code 71250, 1.07 to CPT code 72125,
1.00 to CPT code 72128, and 1.00 to
72131.
(29) Diagnostic Radiology: Upper and
Lower Extremities (CPT Codes 73030–
73700)
As discussed in the CY 2011 final rule
with comment period (75 FR 73341),
CPT codes 73200 (Computed
tomography, upper extremity; without
contrast material) and 73700 (Computed
tomography, lower extremity; without
contrast material) were identified as
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potentially misvalued codes by the FiveYear Review Workgroup under the
‘‘CMS Fastest Growing’’ screen for
potentially misvalued codes. Our
clinical review of CPT codes 73200 and
73700, as with the other CT codes
previously discussed, concluded that
maintaining the current values would
result in an overvaluing of this type of
service. Similar to the other CT codes
previously discussed, the AMA RUC
reviewed the survey results and
accepted the survey physician times but
recommended maintaining the current
work RVUs of 1.09 for both of these
services. We remain concerned over the
validity of the survey results. Therefore,
based on our concern that CT codes
would continue to be misvalued if we
were to accept the AMA RUC
recommendation to maintain the current
values, we assigned alternative work
RVUs of 1.00 (the survey low RVU
value) to CPT codes 73200 and 73700 on
an interim final basis for CY 2011.
Comment: Commenters believed the
surveys were valid and noted the high
response rate relative to other specialty
societies’ surveys conducted on codes
with known current values. The
commenters asserted the AMA RUC’s
review was rigorous and urged CMS to
accept the AMA RUC recommended
work RVUs for CT codes.
Response: Based on comments
received, we referred CPT codes 73200
and 73700 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVU was 1.00 for CPT code 73200
and 1.00 for CPT code 73700. As a result
of the refinement panel ratings and
clinical review by CMS, we are
assigning CY 2012 final work RVU of
1.00 to CPT code 73200 and 1.00 to CPT
code 73700.
Furthermore, for CY 2012, we
received no public comments on the CY
2011 interim final work RVUs for CPT
codes 73080, 73510, 73610, and 73630.
We believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
(30) Diagnostic Ultrasound: Extremities
(CPT Codes 76881–76882)
As discussed in the CY 2011 final rule
with comment period (75 FR 73332), in
October 2008, CPT code 76880
(Ultrasound, extremity, nonvascular,
real time with image documentation)
was identified by the Five-Year Review
Identification Workgroup through its
‘‘CMS Fastest Growing’’ screen for
potentially misvalued codes. In
February 2009, the CPT Editorial Panel
deleted CPT code 76880 and created
two new codes, CPT codes 76881
(Ultrasound, extremity, nonvascular,
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real-time with image documentation;
complete) and 76882 (Ultrasound,
extremity, nonvascular, real-time with
image documentation; limited anatomic
specific) to distinguish between the
comprehensive diagnostic ultrasound
and the focused anatomic-specific
ultrasound. For CPT code 76881, the
AMA RUC recommended work RVUs of
0.72. For CPT code 76882, the AMA
RUC recommended 0.50 work RVUs.
We noted the predecessor CPT code
76880 (Ultrasound, extremity,
nonvascular, real time with image
documentation) described a nonvascular
ultrasound of the entire extremity and
was assigned work RVUs of 0.59. In
contrast, the new CPT codes describe a
complete service, CPT code 76881, and
a limited service, CPT code 76882
(defined as examination of a specific
anatomic structure, such as a tendon or
muscle). As such, for CPT code 76881,
we did not believe an increase in work
RVUs was justified given that this
service will be reported for the
evaluation of the extremity, as was CPT
code 76800 which is being deleted for
CY 2011. Therefore, we assigned a CY
2011 interim work RVU of 0.59 for this
service, which is consistent with the
value of the predecessor code. For CPT
code 76882, we assigned a CY 2011
interim work RVU of 0.41 to maintain
appropriate relativity with CPT code
76800.
Comment: The commenters clarified
that based on Medicare claims data,
podiatry was the dominant provider of
the predecessor code 76880 and their
specialty acknowledged that they more
commonly furnish a limited ultrasound
examination, which will now be
reported as CPT code 76882. CPT code
76881 will now be used for the more
complete examination. The commenters
maintained that the AMA RUCrecommended values for these two
codes were more appropriate than CMS’
CY 2011 interim final values.
Response: Based on comments
received, we referred CPT codes 76881
and 76882 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVU was 0.63 for CPT code 76881
and 0.49 for CPT code 76882. As a result
of the refinement panel ratings and our
clinical review, we are assigning CY
2012 final work RVU of 0.63 to CPT
code 76881 and 0.49 to CPT code 76882.
Furthermore, for CY 2012, we
received no public comments on the CY
2011 interim final work RVUs for CPT
code 74962. We believe these values
continue to be appropriate and are
finalizing them without modification
(Table 15).
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(31) Radiation Oncology: Radiation
Treatment Management (CPT Codes
77427–77469)
CPT code 77427 (Radiation treatment
management, 5 treatments) was
identified as a potentially misvalued
code by the Five-Year Identification
Workgroup’s ‘‘Site-of-Service
Anomalies’’ screen for potentially
misvalued codes in 2007.
As detailed in the CY 2011 PFS final
rule with comment period (75
FR73341), we assigned a work RVU of
3.37 for CPT code 77427 on an interim
final basis for CY 2011. We agreed with
the AMA RUC’s use of the building
block approach to value the treatment
visits associated with CPT code 77427.
The AMA RUC averaged the number of
weekly E/M visits, that is, 4 of CPT code
99214 (Level 4 established patient office
or other outpatient visit) and 2 of CPT
code 99213 (Level 3 established patient
office or other outpatient visit) over 6
weeks to calculate an E/M building
block of 1.32 RVUs. Similarly, to value
the post-operative office visits
associated with this code, the AMA
RUC calculated a building block of 0.57
to account for the average over 6 weeks
of ‘‘E/M visits after treatment planning.’’
The AMA RUC then crosswalked the
physician times for CPT code 77427 to
CPT code 77315 (Teletherapy, isodose
plan (whether hand or computer
calculated); complex (mantle or inverted
Y, tangential ports, the use of wedges,
compensators, complex blocking,
rotational beam, or special beam
considerations)) and used the value of
CPT code 77315 as the remaining
building block for CPT code 77427.
Upon clinical review, we modified
one of the building blocks that the AMA
RUC used to calculate the work RVUs
associated with the treatment E/M office
visits. We believed instead of the
average based upon 4 units of CPT code
99214 and 2 units of CPT code 99213,
a more appropriate estimation was an
average of 3 units of CPT code 99214
and 3 units of CPT code 99213.
Accordingly, we assigned a work RVU
of 3.37 on an interim final basis for CY
2011 for CPT code 77427 (75 FR73341,
corrected in 76 FR 1670). The AMA
RUC recommended a work RVU of 3.45
for CPT code 77427 based on the use of
4 units of CPT code 99214 and 2 units
of CPT code 99213 (75 FR 73341).
Comment: Commenters disagreed
with the interim final work RVU of 3.37,
and supported the AMA RUCrecommended work RVU of 3.45 for
CPT code 77427. Commenters agreed
with the AMA RUC building block of 4
units of 99214 and 2 units of 99213, and
supported this conclusion with
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comparison to other services, CPT codes
95953 (work RVU = 3.30), 77263 (work
RVU = 3.14), and 90962 (work RVU =
3.15). Commenters requested that CMS
accept the AMA–RUC building block of
4 units of 99214 and 2 units of 99213
and a final work RVU of 3.45 for CPT
code 77427.
Response: We appreciate commenters’
support for the building block method
utilized for CPT code 77427. While
commenters agree with the AMA RUCrecommended E/M building blocks, we
continue to believe 3 units of CPT code
99214 and 3 units of CPT code 99213 is
a more appropriate building block for
CPT code 77427. Therefore, we are
finalizing a work RVU of 3.37 for CPT
code 77427 in CY 2012.
(32) Nuclear Medicine: Diagnostic (CPT
Codes 78264)
In the Fourth Five-Year Review (76
FR 32455), we identified CPT code
78264 as potentially misvalued through
the Harvard-Valued—Utilization >
30,000 screen.
As detailed in the Fourth Five-Year
Review, for CPT code 78264 (Gastric
emptying study), we proposed a work
RVU of 0.80 for CPT code 78264 for CY
2012. We believed the 25th percentile
survey value was appropriate based on
its similarity in physician work to other
diagnostic tests. The AMA RUC
reviewed the survey results and
recommended the survey median work
RVU of 0.95 for CPT code 78264 (76 FR
32455).
Comments: Commenters disagreed
with the proposed work RVU of 0.80 for
CPT code 78264. Commenters noted
that the work and time required to
furnish the gastric emptying study has
substantially changed since its last
valuation 20 years ago when it was
Harvard valued. Commenters supported
the AMA RUC-recommended work RVU
of 0.95 for CPT code 78264, the AMA
survey median, which they state is
supported by comparison to the key
reference service, CPT code 78707 (work
RVU = 0.96, total time = 22 minutes).
Commenters also compared this service
to CPT code 78453 (work RVU=1.00,
total time = 20 minutes), which they
stated compared favorably to CPT code
78264 and had similar physician time.
Commenters noted that a work RVU of
0.95 better maintains relativity among
other services, and requested that CMS
accept the AMA RUC-recommended
work RVU of 0.95.
Response: Based on comments we
received, we referred CPT code 78264 to
the CY 2011 multi-specialty refinement
panel for further review. Although
commenters requested that we accept
the AMA RUC-recommended work RVU
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73153
of 0.95, the refinement panel ratings
supported our proposed work RVU of
0.80. We also continue to believe that
the 25th percentile survey value is more
appropriate based on its similarity to
other diagnostic test. Therefore, we are
finalizing the proposed work RVU of
0.80 for CPT code 78264 in CY 2012. We
also finalized the proposed refinements
to time, which can be found on the CMS
Web site at: https://www.cms.gov/
PhysicianFeeSched/.
(33) Pathology and Laboratory:
Urinalysis (CPT Codes 88120, 88121,
88172, 88173, and 88177)
For CY 2011, the AMA’s CPT
Editorial Panel created two new
cytopathology codes that describe in
situ hybridization testing using urine
samples: CPT code 88120
(Cytopathology, in situ hybridization
(e.g., FISH), urinary tract specimen with
morphometric analysis, 3–5 molecular
probes, each specimen; manual) and
CPT code 88121 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis,
3–5 molecular probes, each specimen;
using computer-assisted technology). In
the CY 2011 PFS final rule with
comment period (75 FR 73170), we
assigned a work RVU of 1.20 for CPT
code 88120 and a work RVU of 1.00 for
CPT code 88121 on an interim basis for
CY 2011. However, as detailed in the CY
2012 PFS proposed rule (76 FR 42796),
we asked the AMA RUC to review the
both the direct PE inputs and work
values of the following codes in
accordance with the consolidated
approach to reviewing potentially
misvlaued codes. Therefore, we are
maintaining RVUs of 1.20 for CPT code
88120 and 1.00 for CPT code 88121 on
an interim final basis for CY 2012,
pending the AMA RUC review of these
services. For more information on CPT
codes 88120 and 88121, see section
II.B.5.b.1 of this final rule with
comment period.
In February 2010, the CPT Editorial
Panel revised the descriptor for CPT
code 88172 (Cytopathology, evaluation
of fine needle aspirate; immediate
cytohistologic study to determine
adequacy of specimen(s)) and created a
new code, CPT code 88177
(Cytopathology, evaluation of fine
needle aspirate; immediate
cytohistologic study to determine
adequacy for diagnosis, each separate
additional evaluation episode, same
site), to report the first evaluation
episode and each additional episode of
cytopathology evaluation of fine needle
aspirate. As detailed in the CY 2011 PFS
final rule with comment period (75 FR
73333), we maintained the CY 2010
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work RVU of 0.60 on an interim final
basis for CY 2011 because we did not
believe that the work had changed.
While CPT code 88172 was revised by
the CPT Editorial Panel, the AMA RUC
explanation did not adequately
demonstrate increased work. The AMA
RUC recommended work RVUs of 0.69
based on comparing this code to several
other services, which we did not find to
be an appropriate methodology for
valuing CPT code 88172 (75 FR 73333).
Comment: Commenters disagreed
with the interim final work RVU of 0.60
assigned to CPT code 88172.
Commenters reiterated that CPT code
88177 was added to differentiate
reporting between the first episode and
each additional episode of
cytopathology evaluation of fine needle
aspirate. Commenters stated that the
first episode was more intense than the
subsequent episodes, and requested that
CMS accept the AMA RUCrecommended work RVU of 0.69.
Response: Based on the comments we
received, we referred CPT code 88172 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 0.69. As
a result of the refinement panel and our
clinical review, we are assigning a work
RVU of 0.69 to CPT code 88172 as a
final value.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 88173 and
88177. We believe these values continue
to be appropriate and are finalizing
them without modification (Table 15).
emcdonald on DSK4SPTVN1PROD with RULES2
(34) Immunization Administration for
Vaccines/Toxoids (CPT Codes 90460–
90461)
As detailed in the CY 2011 PFS final
rule with comment period (75 FR
73333), the CPT Editorial Panel revised
the reporting of immunization
administration in the pediatric
population in order to better align the
service with the evolving best practice
model of delivering combination
vaccines. In addition, effective January
1, 2011, reporting and payment for these
services is to be structured on a per
toxoid basis rather than a per vaccine
(combination of toxoids) basis as it was
in prior years. We maintained the CY
2010 work RVUs for the related
predecessor codes since these codes
would be billed on a per toxoid basis in
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CY 2011. We assigned a work RVU of
0.17 for CPT code 90460 (Immunization
administration through 18 years of age
via any route of administration, with
counseling by physician or other
qualified health care profession; first
vaccine/toxoid component) and a work
RVU of 0.15 for CPT code 90461
(Immunization administration through
18 years of age via any route of
administration, with counseling by
physician or other qualified health
profession; each additional vaccine/
toxoid component (List separately in
addition to code for primary procedure))
on an interim final basis for CY 2011.
The AMA RUC recommended a work
RVU of 0.20 for CPT code 90460 and
0.16 for CPT code 90461 (75 FR 73333).
Comment: Commenters disagreed
with the CMS-proposed work RVUs of
0.17 for CPT code 90460 and 0.15 for
CPT code 90461, and stated that the
AMA RUC-recommended work RVUs of
0.20 for CPT code 90460 and 0.16 for
CPT code 90461 are more appropriate.
Commenters noted that the
immunization administration codes
were revised to allow physicians to
accurately report the work involved in
counseling for vaccines with more than
one component. Commenters stressed
that it is inappropriate to crosswalk CPT
codes 90460 and 90461 to their
respective predecessor codes, 90471 and
90472, given the differences in work
involved in patient counseling with CPT
codes 90460 and 90461.
Response: Based on comments we
received, we referred CPT codes 90460
and 90461 to the multi-specialty
refinement panel for further review. The
refinement panel median work RVUs
were 0.23 for CPT code 90460 and 0.17
for CPT code 90461, which were higher
than the AMA RUC-recommended
values. However, we believe it is
appropriate to value these services at
the same rate as their predecessor codes.
We do not agree with commenters that
the addition of counseling in the code
descriptor supports increasing the work
RVUs because CPT codes 90460 and
90461 were restructured to be reported
on a per toxoid basis, rather than a per
vaccine (combination of toxoids) basis
as it was in prior years. After
consideration of public comments,
refinement panel results, and our
clinical review, we are finalizing work
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RVUs of 0.17 for CPT 90460 and 0.15 for
CPT code 90461.
(35) Gastroenterology (CPT Codes
91010–91117)
For CY 2011 the CPT Editorial Panel
restructured a set of CPT codes used to
describe esophageal motility and high
resolution esophageal pressure
topography services. The specialty
societies surveyed their members, and
the AMA RUC issued recommendations
to us for the CY 2011 PFS final rule with
comment period.
As stated in the CY 2011 PFS final
rule with comment period (75 FR
73338), in the esophageal motility and
high resolution esophageal pressure
topography set of services, for CY 2011
two CPT codes were deleted and the
services are now reported under a
revalued existing CPT code 91010
(Esophageal motility (manometric study
of the esophagus and/or
gastroesophageal junction) study with
interpretation and report; 2-dimensional
data) and a new add-on CPT code 91013
(Esophageal motility (manometric study
of the esophagus and/or
gastroesophageal junction) study with
interpretation and report; with
stimulation or perfusion during 2dimensional data study (e.g., stimulant,
acid or alkali perfusion) (List separately
in addition to code for primary
procedure)). We agreed with the AMA
RUC that there was compelling evidence
to change the work RVUs for the
existing CPT code to account for the
inclusion of procedures with higher
work RVUs that would previously have
been reported under the deleted code.
We also agreed with the AMA RUCrecommended work RVUs for the addon code. However, we did not believe
that this structural coding change
should result in an increase in aggregate
physician work for the same services.
Therefore, we believed it would be
appropriate to apply work budget
neutrality to this set of CPT codes. The
work budget neutrality factor for these
2 CPT codes was 0.8500. The AMA
RUC-recommended work RVU, CMSadjusted work RVU prior to the budget
neutrality adjustment, and the CY 2011
interim final work RVU for these
esophageal motility and high resolution
esophageal pressure topography
procedure codes (CPT codes 91010 and
91013) follow.
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28NOR2
Comment: Commenters disagreed
with the application of work budget
neutrality to this set of services and
noted that the specialty societies and
AMA RUC agreed that there was
compelling evidence to change the work
RVUs associated with these services.
Specifically, commenters wrote that
they believed that the current value for
CPT code 91010 was based on an
incorrect assumption; and that
advancements in technology have had
an impact on physician work since the
code was originally valued. They went
on to state that esophageal manometry
is a more comprehensive and complex
study than it was years ago. Based on
these arguments, commenters stated that
work budget neutrality should not be
applied to these codes, and urged CMS
to accept the AMA RUC-recommended
values for these services.
Response: Based on comments we
received, we referred this set of
esophageal motility and high resolution
esophageal pressure topography
procedures (CPT codes 91010 and
91013) to the CY 2011 multi-specialty
refinement panel for further review. The
refinement panel median work RVUs
were 1.50 for CPT code 91010 and 0.21
for CPT code 91013, which were
consistent with the AMA RUCrecommended values for these services.
We continue to believe that the
application of work budget neutrality is
appropriate for this set of clinically
related CPT codes. While we
understand that technology has
advanced since these codes were
originally valued, we do not believe that
these advancements have resulted in
more aggregate physician work. As
such, we believe that allowing an
increase in utilization-weighted RVUs
within this set of clinically related CPT
codes would be unjustifiably
redistributive among PFS services. After
consideration of the public comments,
refinement panel results, and our
clinical review, we are finalizing a work
RVU of 1.28 for CPT code 91010, and a
work RVU of 0.18 for CPT code 91013
for CY 2012.
We received no public comments on
the CY 2011 final rule with comment
period interim work RVUs for CPT
codes 91038 and 91117. We believe
these values continue to be appropriate
and are finalizing them without
modification (Table 15).
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(36) Opthalmology: Special
Opthalmological Services (CPT Codes
92081–92285)
In February, 2010 the CPT Editorial
Panel established two codes for
reporting remote imaging for screening
retinal disease and management of
active retinal disease. As detailed in the
CY 2011 PFS proposed rule (75 FR
73333), for CPT code 92228 (Remote
imaging for monitoring and
management of active retinal disease
(e.g., diabetic retinopathy) with
physician review, interpretation and
report, unilateral or bilateral), we
assigned a work RVU of 0.30 to on an
interim final basis for CY 2011. We
compared this code to another
diagnostic service, CPT code 92135
(Scanning computerized ophthalmic
diagnostic imaging, posterior segment,
(e.g., canning laser) with interpretation
and report, unilateral) (Work RVUs =
0.35), which we believed was more
equivalent than CPT code 92250
(Fundus photography with
interpretation and report) (Work RVU =
0.44), the AMA RUC reference service,
but had more pre- and intra-service
time. Upon further review of CPT code
92228 and the time and intensity
needed to furnish this service, we
assigned a work RVU of 0.30, the survey
low value, on an interim final basis for
CY 2011. The AMA RUC recommended
a work RVU of 0.44 for CPT code 92228
for CY 2011 (75 FR 73333).
Comment: Commenters disagreed
with the CMS interim final work RVU
of 0.030, and requested that CMS accept
the AMA RUC-recommended RVU of
0.44. Commenters disagreed with CMS’
use CPT code 92135 as a comparison
service for the valuation of CPT code
92228. Commenters stated that CPT
code 92250 more accurately reflects the
service involved in CPT code 92228.
Furthermore, commenters raised
concerns regarding a rank order
anomaly with CPT code 92250, which
they stated represents the same
physician work as CPT code 92228, if
CMS finalizes the interim final work
RVU of 0.30 for CPT code 92228.
Response: Based on the comments we
received, we referred CPT code 92228 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVU was 0.37. As
a result of the refinement panel ratings
and our clinical review, we are
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73155
finalizing a work RVU of 0.37 for CPT
code 92228.
For CY 2012, we received no public
comment on the CY 2011 interim final
work RVUs for CPT codes 92132
through 92134 and 9222. We believe
these values continue to be appropriate
and are finalizing them without
modification (Table 15).
(37) Special Otorhinolaryngologic
Services (CPT Codes 92504–92511)
Section 143 of the MIPPA specifies
that speech-language pathologists may
independently report services they
provide to Medicare patients. Starting in
July 2009, speech-language pathologists
were able to bill Medicare as
independent practitioners. As a result,
the American Speech-Language-Hearing
Association (ASHA) requested that CMS
ask the AMA RUC to review the speechlanguage pathology codes to newly
value the professionals’ services in the
work and not the practice expense.
ASHA indicated that it would survey
the 12 speech-language pathology codes
over the course of the CPT 2010 and
CPT 2011 cycles. Four of these services
were reviewed by the HCPAC or the
AMA RUC and were included in the CY
2010 PFS final rule with comment
period (74 FR 61784 and 62146). For CY
2011, the HCPAC submitted work
recommendations for the remaining
eight codes.
As detailed in the CY 2011 PFS final
rule with comment period (75 FR 7333),
for CPT code 92508 (Treatment of
speech, language, voice,
communication, and/or auditory
processing disorder; group, 2 or more
individuals), we assigned a work RVU
of 0.33 on an interim final basis for CY
2011. We derived the work RVU of 0.33
by dividing the value for CPT code
92507 (Treatment of speech, language,
voice, communication, and/or auditory
processing disorder; individual) (work
RVU = 1.30) by 4 participants based on
our understanding from practitioners
that 4 accurately represented the typical
number of participants in a group.
Additionally, the work RVU of 0.33 was
appropriate for this group treatment
service relative to the work RVU of 0.27
for CPT code 97150 (Therapeutic
procedure(s), group (2 or more
individuals)), which is furnished to a
similar patient population, namely
patients who have had a stroke. The
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HCPAC recommended a work RVU of
0.43 for CPT code 92508 for CY 2011 (75
FR 7333).
Comment: Commenters disagreed
with the interim final work RVU of 0.33
for CPT code 92508, and asserted that
the HCPAC recommendation of a work
RVU of 0.43 was more appropriate.
Commenters disagreed with using 4
participants to value CPT code 92508,
requesting that CMS assume 3 as the
typical number of participants in a
group. Commenters also disagreed with
CMS’ comparison with CPT code 97150,
asserting that this service is furnished to
a dissimilar patient population by other
professional groups. Commenters
requested that we accept the HCPACrecommended work RVU of 0.43 for
CPT code 92508.
Response: Based on comments we
received, we referred CPT code 92508 to
the CY 2011 multi-specialty refinement
panel for further review. The refinement
panel supported that HCPACrecommended value of 0.43. As stated
previously based on our understanding
of this service, we believe that dividing
the value for CPT code 92507 by 4
participants more appropriately values
CPT code 92508. Furthermore, as stated
in CY 2012 PFS final rule with comment
period (75 FR 7333), CPT code 97150
(work RVU = 0.27) is furnished to a
similar patient population. We believe a
work RVU of 0.33 for CPT code 92508
creates appropriate relativity to CPT
code 97150. After consideration of the
public comments, refinement panel
results, and our clinical review, we are
finalizing a work RVU of 0.33 for CPT
code 92508.
As detailed in the Fourth Five-Year
Review, for CPT code 92511
(Nasopharyngoscopy with endoscope
(separate procedure)) we proposed a
work RVU of 0.61 for CY 2012. The
AMA RUC recommended a work RVU
of 0.61 for this service as well. For CPT
code 92511, the AMA RUC
recommended the following times: preservice evaluation time of 6 minutes;
pre-service (dress, scrub, wait) of 5
minutes; an intra-service time of 5
minutes; and a post-service time of 5
minutes. We proposed a pre-service
evaluation time for CPT code 92511 of
4 minutes, pre-service (dress, scrub,
wait) of 5 minutes, an intra-service time
of 5 minutes, and a post-service time of
3 minutes to account for the E/M service
begin provided on the same day (76 FR
32455).
Comment: In its public comment to
CMS on the Fourth Five-Year Review,
the AMA RUC wrote that CMS agreed
with the AMA RUC-recommended work
RVU, but noted that CMS disagreed
with the AMA RUC recommended pre-
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service and post-service time
components due to an E/M service
typically being provided on the same
day of service. The AMA RUC
recommends that CMS accept the AMA
RUC-recommended pre-service
evaluation time of 6 minutes and
immediate post-service time of 5
minutes for CPT code 92511.
Response: In response to comments,
we re-reviewed the descriptions of preservice work and the recommended preservice time packages for CPT code
92511. We disagree with the times
recommended by the AMA RUC, and
we do not believe the recommended
times account for the overlap with an E/
M service typically billed on the same
day of service. We continue to believe
our proposal to reduce the pre- and
post-service time by 2 minutes is
appropriate for this service. For CPT
code 92511, we are finalizing a work
RVU of 0.61. In addition, we are
finalizing a pre-service evaluation time
of 4 minutes, pre-service (dress, scrub,
wait) time of 5 minutes, an intra-service
time of 5 minutes, and a post-service
time of 3 minutes for CPT code 92511.
CMS time refinements can be found in
Table 16.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT Codes 92504,
92507, and 92508. We believe these
values continue to be appropriate and
are finalizing them without
modification (Table 15).
(38) Special Otorhinolaryngologic
Services: Evaluative and Therapeutic
Services (CPT Codes 92605–92618)
As detailed in the CY 2011 PFS final
rule with comment period (75 FR 7333),
for CPT code 92606 (Therapeutic
service(s) for the use of non-speech
generating device, including
programming and modification), we
published the AMA RUC-recommended
work RVU of 1.40 in Addendum B to
the final rule with comment period in
accordance with our usual practice for
bundled services. This service is
currently bundled under the PFS and
we maintained the bundled status for
CY 2011.
Comment: Commenters requested that
CMS consider applying an active
Medicare status to this service to be
covered by Medicare.
Response: As stated previously, CPT
code 92606 is currently bundled and
paid as a part of other services on the
PFS. We do not pay separately for
services that are included in other paid
services, as this would amount to
double payments for those services. We
are maintaining the bundled status for
CPT code 92606 for CY 2012.
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For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 92607
through 92609. We believe these values
continue to be appropriate and are
finalizing them without modification
(Table 15).
(39) Cardiovascular: Therapeutic
Services and Procedures (CPT Codes
92950)
In the Fourth Five-Year Review, CMS
identified CPT code 92950
(Cardiopulmonary resuscitation (e.g., in
cardiac arrest)) as potentially misvalued
through the Harvard-Valued—
Utilization >30,000 screen. As detailed
in the Fourth Five-Year Review of Work,
for CPT code 92950 (Cardiopulmonary
resuscitation (e.g., in cardiac arrest)), we
proposed a work RVU of 4.00 for CY
2012. The AMA RUC reviewed the
survey results and recommended the
median survey work RVU of 4.50 for
CPT code 92950. We recognized that
patients that undergo this service are
very ill; however, we did not believe
that the typical patient met all the
criteria for the critical care codes.
Furthermore, the most currently
available Medicare PFS claims data
showed that CPT code 92950 is
typically furnished on the same day as
an E/M visit. We believed some of the
pre- and post- service time should not
be counted in developing this
procedure’s work value. As described in
section III.A., to account for this
overlap, we reduced the pre-service
evaluation and post service time by onethird. We believed that 1 minute preservice evaluation time and 20 minutes
post-service time accurately reflect the
time required to conduct the work
associated with this service.
Comment: Commenters disagreed
with the CMS-proposed work RVU of
4.00 of CPT code 92950 and believe that
the AMA RUC recommended work RVU
of 4.50 is more appropriate.
Additionally, commenters asserted that
a patient requiring cardiopulmonary
resuscitation is clearly as intense as
critical care definition having a high
probability of imminent life threatening
deterioration. Furthermore, commenters
note that utilization data show that CPR
is not typically reported with an E/M
code.
Response: Based on the comments
received, we referred CPT code 92950 to
the CY 2011 multi-specialty refinement
panel for further review. Although the
refinement panel median work RVU was
4.50, which was consistent with the
AMA RUC-recommendation for this
service. The Medicare PFS claims data
show that there is an E/M visit billed on
the same day as CPT code 92950 more
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than 50 percent of the time. We do not
believe it is appropriate for this service
to reflect the aforementioned E/M visit
overlap, which would result in
duplicate recognition of activities
associated with pre- and post- service
times. In order to ensure consistent and
appropriate valuation of physician
work, we believe it is appropriate to
apply our methodology to address
services for which there is typically a
same-day E/M service. Therefore, we are
finalizing a work RVU for CPT code
92950 of 4.00 in CY 2012 with
refinements to time. A complete list of
CMS time refinements can be found in
Table 16.
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(40) Neurology and Neuromuscular
Procedures: Sleep Testing (CPT Codes
95800–95811)
Sleep testing CPT codes were
identified by the Five-Year Review
Identification Workgroup as potentially
misvalued codes through the ‘‘CMS
Fastest Growing’’ potentially misvalued
codes screen. The CPT Editorial Panel
created separate Category I CPT codes to
report for unattended sleep studies. The
AMA RUC recommended concurrent
review of the family of sleep codes.
As detailed in the CY 2011 PFS final
rule with comment period (75 FR
73334), we assigned a work RVU of 1.25
for CPT codes 95806 (Sleep study,
unattended, simultaneous recording of,
heart rate, oxygen saturation, respiratory
airflow, and respiratory effort (e.g.,
thoracoabdominal movement)) and a
work RVU of 1.28 for CPT code 95807
(Sleep study, simultaneous recording of
ventilation, respiratory effort, ECG or
heart rate, and oxygen saturation,
attended by a technologist) on an
interim basis for CY 2011. The AMA
RUC recommended work RVUs of 1.28
for CPT code 95806 and 1.25 for CPT
code 95807. Although the AMA RUCrecommended values for these codes
reflect the survey 25th percentile, we
disagreed with the values and believed
the values should be reversed because of
the characteristics of the services. CPT
code 95807 has 5 minutes more preservice time but a lower AMA RUCrecommended value. We did not receive
any public comments that disagreed
with the interim final work values.
Therefore, we are finalizing work RVUs
of 1.25 for CPT code 95806 and 1.28 for
CPT code 95807.
For CY 2012, we received no public
comments on the CY 2011 interim final
work RVUs for CPT codes 95800, 95801,
95803, 95805, 95808, 95810, and 95811.
We believe these values continue to be
appropriate and are finalizing them
without modification (Table 15).
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(41) Osteopathic Manipulative
Treatment (CPT Codes 98925–98929)
In the Fourth Five-Year Review (76
FR 32456 through 32458), we identified
CPT codes 98925, 98928 and 98929 as
potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen. Additionally, the American
Osteopathic Association identified CPT
codes 98926 and 98927 to be reviewed
as part of this family since these were
also identified to be reviewed by the
AMA RUC Relativity Assessment
Workgroup because these codes were
identified through the HarvardValued—Utilization > 100,000 screen.
We reviewed CPT codes 98925
through 98929 and published proposed
work RVUs in the Fourth Five-Year
Review of Work (76 FR 32456 through
32458). Based on comments we received
during the public comment period, we
referred CPT codes 98925 through
98929 to the CY 2011 multi-specialty
refinement panel for further review.
For CPT code 98925 (Osteopathic
manipulative treatment (OMT); 1–2
body regions involved), we proposed a
work RVU of 0.46 in the Fourth FiveYear Review (76 FR 32456). We also
refined the time associated with CPT
code 98925. Recent PFS claims data
showed that this service is typically
furnished on the same day as an E/M
visit. While we understand that there
are differences between these services,
we believed some of the activities
conducted during the pre- and postservice times of the osteopathic
manipulative treatment code and the E/
M visit overlapped and should not be
counted in developing the work RVUs
for this service. As described earlier in
section III.A. of this final rule with
comment period, we reduced the preservice evaluation and post-service time
by 1x3 to account for the overlap. We
believed that 1 minute of pre-service
evaluation time and 2 minutes postservice time accurately reflected the
time required to conduct the work
associated with this service.
As detailed in the Fourth Five-Year
Review (76 FR 32456), we calculated the
value of the extracted time and
subtracted it from the AMA RUCrecommended work RVU of 0.50. For
CPT code 98925, we removed a total of
2 minutes from the AMA RUCrecommended pre- and post-service
times, which amounts to the removal of
.04 of a work RVU, resulting in a work
RVU of 0.46. We noted that 70 percent
of the survey respondents indicated that
the work of furnishing this service has
not changed in the past 5 years (current
RVU = 0.45). We proposed a work RVU
of 0.46, with refinement in time for CPT
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code 98925 for CY 2012. CMS time
refinements can be found in Table 16.
The AMA RUC recommended a work
RVU of 0.50 for CPT code 98925.
For CPT code 98926 (Osteopathic
manipulative treatment (OMT); 3–4
body regions involved), we proposed a
work RVU of 0.71 in the Fourth FiveYear Review (76 FR 32456). We also
refined the time associated with CPT
code 98926. Recent PFS claims data
showed that this service is typically
furnished on the same day as an E/M
visit. While we understand that there
are differences between these services,
we believed some of the activities
conducted during the pre- and postservice times of the osteopathic
manipulative treatment code and the E/
M visit overlapped and should not be
counted in developing the work RVUs
for this service. As described earlier in
section III.A. of this final rule with
comment period, we reduced the preservice evaluation and post-service time
by one-third to account for the overlap.
We believed that 1 minute of pre-service
evaluation time and 2 minutes postservice time accurately reflected the
time required to conduct the work
associated with this service.
As detailed in the Fourth Five-Year
Review (76 FR 32456), we calculated the
value of the extracted time and
subtracted it from the AMA RUCrecommended work RVU of 0.75. For
CPT code 98926, we removed a total of
2 minutes from the AMA RUCrecommended pre- and post-service
times, which amounts to the removal of
.04 of a work RVU, resulting in a work
RVU of 0.71. We noted that 81 percent
of the survey respondents indicated that
the work of furnishing this service has
not changed in the past 5 years (current
RVU = 0.65). We proposed an
alternative work RVU of 0.71, with
refinement in time for CPT code 98926
for CY 2012. CMS time refinements can
be found in Table 16. The AMA RUC
recommended a work RVU of 0.75 for
CPT code 98926.
For CPT code 98927 (Osteopathic
manipulative treatment (OMT); 5–6
body regions involved), we proposed a
work RVU of 0.96 in the Fourth FiveYear Review (76 FR 32457). We also
refined the time associated with CPT
code 98927. Recent PFS claims data
showed that this service is typically
furnished on the same day as an E/M
visit. While we understand that there
are differences between these services,
we believed some of the activities
conducted during the pre- and postservice times of the osteopathic
manipulative treatment code and the E/
M visit overlapped and should not be
counted in developing the work RVUs
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for this service. As described earlier in
section III.A. of this final rule with
comment period, we reduced the preservice evaluation and post-service time
by one-third to account for the overlap.
We believed that 1 minute of pre-service
evaluation time and 2 minutes postservice time accurately reflected the
time required to conduct the work
associated with this service.
As detailed in the Fourth Five-Year
Review (76 FR 32457), we calculated the
value of the extracted time and
subtracted it from the AMA RUCrecommended work RVU of 1.00. For
CPT code 98927, we removed a total of
2 minutes from the AMA RUCrecommended pre- and post-service
times, which amounts to the removal of
0.04 of a work RVU, resulting in a work
RVU of 0.96. We noted that 77 percent
of the survey respondents indicated that
the work of furnishing this service has
not changed in the past 5 years (current
RVU = 0.87). We proposed a work RVU
of 0.96, with refinement in time for CPT
code 98927 for CY 2012. CMS time
refinements can be found in Table 16.
The AMA RUC recommended a work
RVU of 1.00 for CPT code 98927.
For CPT code 98928 (Osteopathic
manipulative treatment (OMT); 7–8
body regions involved), we proposed a
work RVU of 1.21 in the Fourth FiveYear Review (76 FR 32457). We also
refined the time associated with CPT
code 98928. Recent PFS claims data
showed that this service is typically
furnished on the same day as an E/M
visit. While we understand that there
are differences between these services,
we believed some of the activities
conducted during the pre- and postservice times of the osteopathic
manipulative treatment code and the E/
M visit overlapped and should not be
counted in developing the work RVUs
for this service. As described earlier in
section III.A. of this final rule with
comment period, we reduced the preservice evaluation and post-service time
by one-third to account for the overlap.
We believed that 1 minute of pre-service
evaluation time and 2 minutes postservice time accurately reflected the
time required to conduct the work
associated with this service.
As detailed in the Fourth Five-Year
Review (76 FR 32457), we calculated the
value of the extracted time and
subtracted it from the AMA RUCrecommended work RVU of 1.25. For
CPT code 98928, we removed a total of
2 minutes from the AMA RUCrecommended pre- and post-service
times, which amounts to the removal of
0.04 of a work RVU, resulting in a work
RVU of 1.21. We noted that 67 percent
of the survey respondents indicated that
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the work of furnishing this service has
not changed in the past 5 years (current
RVU = 1.03). We proposed a work RVU
of 1.21, with refinement in time for CPT
code 98928 for CY 2012. CMS time
refinements can be found in Table 16.
The AMA RUC recommended a work
RVU of 1.25 for CPT code 98928.
For CPT code 98929 (Osteopathic
manipulative treatment (OMT); 9–10
body regions involved), we proposed a
work RVU of 1.46 in the Fourth FiveYear Review (76 FR 32457). We also
refined the time associated with CPT
code 98929. Recent PFS claims data
showed that this service is typically
furnished on the same day as an E/M
visit. While we understand that there
are differences between these services,
we believed some of the activities
conducted during the pre- and postservice times of the osteopathic
manipulative treatment code and the E/
M visit overlapped and should not be
counted in developing the work RVUs
for this service. As described earlier in
section III.A. of this final rule with
comment period, we reduced the preservice evaluation and post-service time
by 1x3 to account for the overlap. We
believed that 1 minute of pre-service
evaluation time and 2 minutes postservice time accurately reflected the
time required to conduct the work
associated with this service.
As detailed in the Fourth Five-Year
Review (76 FR 32457), we calculated the
value of the extracted time and
subtracted it from the AMA RUCrecommended work RVU of 1.50. For
CPT code 98929, we removed a total of
2 minutes from the AMA RUCrecommended pre- and post-service
times, which amounts to the removal of
.04 of a work RVU, resulting in a work
RVU of 1.46. We noted that 63 percent
of the survey respondents indicated that
the work of furnishing this service has
not changed in the past 5 years (current
RVU = 1.19). We proposed a work RVU
of 1.46, with refinement in time for CPT
code 98928 for CY 2012. CMS time
refinements can be found in Table 16.
The AMA RUC recommended a work
RVU of 1.50 for CPT code 98929.
Comment: Commenters disagreed
with the CMS-proposed work RVUs for
these osteopathic manipulative
treatment services, and state that the
AMA RUC-recommended RVUs of 0.50
for CPT code 98925, 0.75 for CPT code
98926, 1.00 for CPT code 98927, 1.25 for
CPT code 98928, 1.50 for CPT code
98929 are more appropriate.
Commenters reminded CMS that the
AMA RUC incorporated reductions in
the pre- and post-service times
recommended in the specialty’s survey
of the codes. Commenters noted that the
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proposed work RVUs were derived from
the reverse building block methodology,
which removed 0.04 from the AMA
RUC-recommended RVUs for CPT codes
98925 through 98929 to account for the
overlap with the E/M services.
Commenters also found that the
survey responses indicating that the
work of furnishing these services had
not changed in the past 5 years were
irrelevant to valuing these services
because there was compelling evidence
that the methodology was flawed in the
original valuation of these codes.
Commenters requested that CMS accept
the AMA RUC-recommended work
RVUs and physician time.
Response: Based on the comments we
received, we referred CPT codes 98925,
98926, 98927, 98928, and 98929 to the
CY 2011 multi-specialty refinement
panel for further review. The refinement
panel median work RVUs were 0.49,
0.74, 0.99, 1.24, 1.49 for CPT codes
98925, 98926, 98927, 98928, and 98929,
respectively. While the AMA RUC
asserts that it reduced physician times
to account for the E/M service on the
same day, we do not believe the
recommended physician times
adequately account for the overlap in
services with an E/M visit on the same
day. We continue to believe that some
of the activities in the pre- and postservice times of the osteopathic
manipulative treatment codes and the E/
M visit overlap, and that our proposal
to remove 1 minute of pre- and 1 minute
of post-service time appropriately
accounts for this overlap. As detailed
earlier in section III.A. of this final rule
with comment period, we do not believe
the overlap in activities should be
counted in developing these procedures’
work values. In order to ensure
consistent and appropriate valuation of
physician work, we are continuing with
the application of our methodology,
explained in the Fourth Five-Year
Review (76 FR 32422), to address the
overlapping activities when a service is
typically billed on the same day as an
E/M service. After consideration of the
public comments, refinement panel
results, survey responses, and our
clinical review, we are finalizing the
proposed work RVUs and refined times
associated with these codes. CMS time
refinements can be found in Table 16.
We are finalizing work RVUs of 0.46 for
CPT code 98925, 0.71 for CPT code
98926, 0.96 for CPT code 98927, 1.21 for
CPT code 98928, 1.46 for CPT code
98929.
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(42) Evaluation and Management: Initial
Observation Care (CPT Codes 99218–
99220)
In the Fourth Five-Year Review (76
FR 32458), we identified CPT codes
99218 through 99220 as potentially
misvalued through the HarvardValued—Utilization > 30,000 screen.
The American College of Emergency
Physicians (ACEP) submitted a public
comment identifying CPT codes 99218
through 99220 to be reviewed in the
Fourth Five-Year Review. ACEP also
identified CPT codes 99234 through
99236 as part of the family of services
for AMA RUC review. For CPT codes
99218 (Level 1 initial observation care,
per day), 99219 (Level 2 initial
observation care, per day), and 99220
(Level 3 initial observation care, per
day), we stated that we believed there
were differences in physician work in
the outpatient and inpatient settings,
and proposed work RVUs of 1.28 for
CPT code 99218, 2.14 for CPT code
99219, and 2.99 for CPT code 99220.
We agreed with the AMA RUC that
appropriate relativity must be
maintained within and between the
families of similar codes. However, we
believed that while the work RVUs of
the initial observation care codes
(99218, 99219, and 99220) should be
greater than those of the subsequent
observation care codes (99224, 99225,
and 99226), we did not believe the work
RVUs of the initial observation care
codes (99218, 99219, and 99220) should
be equivalent (or close) to the initial
hospital care codes (99221, 99222, and
99223). We noted that we believed the
acuity level of the typical patient
receiving outpatient observation
services would generally be lower than
that of the inpatient level. We believed
the work RVUs of the initial observation
care codes should reflect the modest
differences in patient acuity between
the outpatient and inpatient settings.
We compared the CY 2011 work RVUs
of the initial observation care codes to
the CY 2011 interim final work RVUs of
the subsequent observation care codes
and found that the relativity existing
between these codes was acceptable. We
also believed that the CY 2011 work
RVUs of the initial observation care
codes maintained the proper rank order
with the initial hospital care services.
Therefore, we proposed to maintain the
CY 2011 work RVUs for CPT codes
99218, 99219, and 99220. We accepted
the survey median physician times for
these codes, as recommended by the
AMA RUC. CMS time refinements can
be found in Table 16. The AMA RUC
asserted that a rank order anomaly
existed within this family of codes as
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the observation care codes have an
analogous relationship to the initial
hospital care codes (99221 through
99223), and recommended work RVUs
of 1.92 for CPT code 99218, 2.60 for CPT
code 99219, and 3.56 for CPT code
99220.
Comment: Commenters disagreed
with the proposed RVUs for CPT codes
99218, 99219, and 99220. Commenters
stressed that the physician work is the
same whether the patient is in
observation status or admitted to the
hospital. Commenters stated that these
initial observation care codes should be
valued consistently with initial hospital
care codes (99221, 99222, and 99223).
Commenters stated that a patient’s
classification by a hospital as inpatient
or outpatient does not necessarily
equate to patient acuity relevance for a
physician. Furthermore, commenters
noted that hospital classification of
patients as inpatient or outpatient may
be in response to hospital policies,
facility resource utilization, or other
factors, while physician work is
described within CPT guidelines for the
E/M codes. Commenters requested that
CMS accept the AMA RUCrecommended work RVUs of 1.92 for
CPT code 99218, 2.60 for CPT code
99219, and 3.56 for CPT code 99220
with the AMA RUC-recommended
physician times.
Response: Based on comments we
received, we referred CPT codes 99218,
99219, and 99220 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVUs were 1.92 for CPT code
99218, 2.60 for CPT code 99219, and
3.56 for CPT code 99220. As a result of
the refinement panel ratings and our
clinical review, we are finalizing work
RVUs of 1.92 for CPT code 99218, 2.60
for CPT code 99219, and 3.56 for CPT
code 99220. We are also finalizing the
AMA RUC-recommended physician
times. CMS time refinements can be
found in Table 16.
(43) Evaluation and Management:
Subsequent Observation Care (CPT
Codes 99224–99226)
At the June 2009 CPT Editorial Panel
meeting, three new codes were
approved to report subsequent
observation services in a facility setting.
These codes are CPT code 99224 (Level
1 subsequent observation care, per day);
CPT code 99225 (Level 2 subsequent
observation care, per day); and CPT
code 99226 (Level 3 subsequent
observation care, per day). Observation
services are outpatient services ordered
by a patient’s treating practitioner. In
the CY 2011 PFS final rule with
comment period (75 FR 73334), we
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assigned interim final work RVUs of
0.54 to CPT code 99224, 0.96 to CPT
code 99225, and 1.44 to CPT code 99226
for CY 2011. As detailed in the CY 2011
PFS final rule with comment period, we
stated that there are generally
differences in patient acuity between
the inpatient and outpatient settings. To
account for these differences, we
removed the pre- and post-services
times from the AMA RUCrecommended values for subsequent
observation care, reducing the values to
approximately 75 percent of the values
for the subsequent hospital care codes.
The AMA RUC recommended work
RVUs of 0.76 for CPT code 99224, 1.39
for CPT code 99225, and 2.00 for CPT
99226.
Comment: Commenters disagreed
with the interim final RVUs for the CPT
codes 99224, 99225, and 99226.
Commenters stressed that the physician
work is the same whether the patient is
admitted to the hospital or in
observation status, and should be
valued consistently with subsequent
hospital care codes (99231, 99232, and
99233). Commenters also disagreed with
CMS removing the pre- and post-service
time for valuation of these codes.
Commenters stated that subsequent
observation care involves physician
time and work before and after the
patient encounter. Commenters
requested that CMS accept the AMA
RUC-recommended RVUs of 0.76 for
99224, 1.39 for 99225, and 2.00 for
99226, which correlate to the
subsequent hospital care codes (99231,
99232, and 99233).
Response: Based on the comments we
received, we referred CPT codes 99224,
99225, and 99226 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVUs were 0.76 for 99224, 1.39 for
99225, and 2.00 for 99226. As a result
of the refinement panel ratings and our
clinical review, we are finalizing work
RVUs of 0.76 for 99224, 1.39 for 99225,
and 2.00 for 99226. We are also
finalizing the AMA RUC-recommended
pre- and post-service times. CMS time
refinements can be found in Table 16.
(44) Evaluation and Management:
Subsequent Hospital Care (CPT Codes
99234–99236)
In the Fourth Five-Year Review (76
FR 32458), for CPT codes 99234 (Level
1, observation or inpatient hospital care,
for the evaluation and management of a
patient including admission and
discharge on the same date); 99235
(Level 2, observation or inpatient
hospital care, for the evaluation and
management of a patient including
admission and discharge on the same
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date); and 99236 (Level 3 observation or
inpatient hospital care, for the
evaluation and management of a patient
including admission and discharge on
the same date), we proposed a work
RVUs of 1.92 for CPT code 99234, 2.78
for CPT code 99235, and 3.63 for CPT
code 99236. We followed the same
approach to valuing these observation
same day admit/discharge services as
the AMA RUC—taking the
corresponding initial observation care
code of the same level, plus half the
value of a hospital discharge day
management service. However, we
incorporated the Fourth Five-Year
Review proposed values for CPT codes
99218, 99219, and 99220 discussed
previously. We also made
corresponding physician time changes.
CMS time refinements can be found in
Table 16. The AMA RUC recommended
2.56 for CPT code 99234, 3.24 for CPT
code 99235, and 4.20 for CPT code
99236 based on the same methodology,
but incorporated the AMA RUCrecommended RVUs for 99218, 99219,
and 99220, respectively.
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Comment: Commenters disagreed
with the proposed RVUs for CPT codes
99234, 99235, and 99236. Commenters
supported the methodology CMS and
the AMA RUC used to value these
services of taking the corresponding
initial observation care code of the same
level, plus half the value of a hospital
discharge day management service, but
commenters disagreed with the
underlying initial observation care code
RVUs. Commenters requested that CMS
continue to apply the same
methodology from the Fourth Five-Year
Review. However, commenters
requested that CMS use the AMA RUCrecommended RVUs, rather than the
CMS proposed values for the initial
observation care codes in the
calculation of RVUs for CPT codes
99234, 99235, and 99236. Commenters
requested that CMS accept the AMA
RUC-recommended RVUs of 2.56 for
CPT code 99234, 3.24 for CPT code
99235, and 4.20 for CPT code 99236
with the AMA RUC-recommended
physician times.
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Response: Based on the comments we
received, we referred CPT codes 99224,
99225, and 99226 to the CY 2011 multispecialty refinement panel for further
review. The refinement panel median
work RVUs were 2.56 for CPT code
99234, 3.24 for CPT code 99235, and
4.20 for CPT code 99236. As a result of
the refinement panel ratings and our
clinical review, we are finalizing work
RVUs of 2.56 for CPT code 99234, 3.24
for CPT code 99235, and 4.20 for CPT
code 99236. We are also finalizing the
AMA RUC-recommended physician
times. CMS time refinements can be
found in Table 16.
As noted previously, for all CY 2011
new, revised, or potentially misvalued
codes with CY 2011 interim final work
RVUs that are not specifically discussed
in this final rule with comment period,
we are finalizing, without modification,
the interim final direct PE inputs that
we initially adopted for CY 2011. Table
15 provides a comprehensive list of all
final values.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
2. Finalizing CY 2011 Interim Direct PE
RVUs for CY 2012
a. Background and Methodology
In this section, we address interim
final direct PE inputs as presented in
the CY 2011 PFS final rule with
comment period and displayed in the
final CY 2011 direct PE database (as
subsequently corrected on December 30,
2010) available on the CMS Web site
under the downloads for the ‘‘Payment
Policies under Physician Fee Schedule
and other Revisions to Part B for CY
2011; Corrections’’ at: https://
www.cms.gov/PhysicianFeeSched/
PFSFRN/list.asp.
On an annual basis, the AMA RUC
provides CMS with recommendations
regarding direct PE inputs, including
clinical labor, supplies, and equipment,
for new, revised, and potentially
misvalued codes. We review the AMA
RUC-recommended direct PE inputs on
a code-by-code basis, including the
recommended facility PE inputs and/or
nonfacility PE inputs, as clinically
appropriate for the code. We determine
whether we agree with the AMA RUC’s
recommended direct PE inputs for a
service or, if we disagree, we refine the
PE inputs to represent inputs that better
reflect our estimate of the PE resources
required for the service in the facility
and/or nonfacility settings. We also
confirm that CPT codes should have
facility and/or nonfacility direct PE
inputs and make changes based on our
clinical judgment and any PFS payment
policies that would apply to the code.
In the CY 2011 PFS final rule with
comment period (75 FR 73350), we
addressed the general nature of some
common refinements to the AMA RUCrecommended direct PE inputs as well
as the reasons for refinements to
particular inputs. In the following
subsections, we respond to comments
we received regarding common
refinements and the direct PE inputs
specific to particular codes.
b. Common Refinements
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(1) General Equipment Time
As we stated in the CY 2011 PFS final
rule with comment period (75 FR
73350), many of the refinements to the
AMA RUC direct PE recommendations
were made in the interest of promoting
a transparent and consistent approach to
equipment time inputs. In the past, the
AMA RUC had not always provided us
with recommendations regarding
equipment time inputs. In CY 2010, we
requested that the AMA RUC provide
equipment times along with the other
direct PE recommendations, and we
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provided the AMA RUC with general
guidelines regarding appropriate
equipment time inputs. We appreciate
the AMA RUC’s willingness to provide
us with these additional inputs as part
of their direct PE recommendations.
In general, the equipment time inputs
correspond to the intra-service portion
of the clinical labor times. We have
clarified that assumption to consider
equipment time as the sum of the times
within the intra-service period when a
clinician is using the piece of
equipment, plus any additional time the
piece of equipment is not available for
use for another patient due to its use
during the designated procedure. In
addition, when a piece of equipment is
typically used during additional visits
included in a service’s global period, the
equipment time should also reflect that
use.
Certain highly technical pieces of
equipment and equipment rooms are
less likely to be used by a clinician over
the full course of a procedure and are
typically available for other patients
during time that may still be in the
intra-service portion of the service. We
adjust those equipment times
accordingly. For example, CPT code
74178 (Computed tomography,
abdomen and pelvis; without contrast
material in more than one body region)
includes 3 minutes of intra-service
clinical labor time associated with
obtaining the patient’s consent for the
procedure. Since it would be atypical
for this activity to occur within the CT
room, we believe these 3 minutes
should not be attributed to the CT room
as equipment time. We refined the CY
2011 AMA RUC direct PE
recommendations to conform to these
equipment time policies.
Comment: One commenter expressed
concerns with CMS’ overall
methodology for computing equipment
times. The commenter specifically
addressed CMS’ refinement of minutes
allocated to an angiography room for a
series of endovascular revascularization
procedures. The commenter claimed
that in the case of interventional
radiology procedures, a nurse typically
greets and gowns the patient, provides
pre-service education, and obtains
consent and vital signs in an
angiography room or other procedure
room. Additionally, the commenter
asserted that since CMS provided
general guidelines to the RUC regarding
appropriate equipment time inputs,
CMS should defer to the expertise of the
AMA RUC and accept the
recommendations for equipment times.
Further, the commenter argued that by
not allocating minutes for certain highly
technical pieces of equipment and
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equipment rooms for greeting/gowning,
obtaining vital signs or providing preservice education, CMS is instituting a
change in practice expense methodology
without discussing it with stakeholders
prior to implementation.
Another commenter expressed similar
concerns regarding CMS’ refinements of
equipment minutes allocated to a CT
room for a series of new codes that
describe combined CTs of the abdomen
and pelvis. This commenter argued that
equipment minutes should be allocated
based on the full number of minutes in
the clinical labor intraservice time
since, for example, even when a CT
technologist greets a patient in a
different room, the CT room cannot be
used for another patient. This
commenter argued that current CMS
allocation of room minutes is
inconsistent with the historically
accepted premise that if the
technologists are involved with a
patient, the room cannot be used for a
different patient until after it has been
cleaned and therefore 100 percent of the
clinical labor time should be attributed
to ‘‘Room Time.’’ Both commenters
argued that CMS should accept the
direct PE input recommendations of the
AMA RUC, without refining the
equipment room minutes that were
allocated for greeting/gowning,
obtaining vital signs or providing preservice education or obtaining consent.
Response: We continue to believe that
equipment minutes should be allocated
as the sum of the intra-service minutes
that a clinician typically uses a piece of
equipment and the equipment is
typically unavailable to other patients
due to its use during the designated
procedure. For many services, this
means that the equipment is allocated
the full number of minutes during the
intra-service period. For example, for
many services, the three clinical labor
minutes attributed to a nurse for
greeting and gowning the patient prior
to the procedure are then also logically
allocated to the exam table (EF023). We
believe that this allocation reflects
typical use of the equipment since it is
logical to assume that the patient is
usually greeted and gowned in the room
that contains the exam table.
In the case of services that require the
use of certain highly technical pieces of
equipment and equipment rooms,
however, we believe it is inappropriate
to assume that all of the same intraservice clinical labor activities typically
make these equipment items
unavailable for use in furnishing
services to other patients. For example,
we do not believe it is typical to occupy
a CT room while gowning a patient,
providing pre-service education, or
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obtaining consent of a patient prior to
performing a procedure since those
activities are not dependent on access to
the equipment. Therefore, we do not
agree with the commenter’s assertion
that these highly technical pieces of
equipment and equipment rooms are
typically unavailable to other patients
whenever any patient is greeted,
gowned, provided pre-service
education, or has vital signs taken. That
is why we do not allocate equipment
minutes in those cases. We reiterate that
equipment minutes are allocated based
on the time a clinician typically uses a
piece of equipment and the equipment
is typically unavailable to other patients
due to its use during the designated
procedure.
While recent RUC recommendations
have often reflected an agreement with
that principle, some of the
recommendations have required CMS
refinements to make sure the equipment
time minutes adhere to these principles.
We note that we have only recently
asked the RUC to provide CMS with
recommendations regarding equipment
time, and both CMS and the RUC
considered the CY 2011 refinements to
be technical modifications to the direct
PE input recommendations instead of
disagreements. Therefore, we do not
agree with the commenters’ premise that
these refinements to equipment time are
necessarily in conflict with the clinical
judgment of the RUC.
We understand commenters’ concerns
regarding the importance of accurate
and consistent allocation of equipment
minutes as direct PE inputs. We agree
that equipment minutes have not always
been allocated with optimal precision,
and we believe that imprecise allocation
of equipment minutes may be a factor in
certain potentially misvalued codes. We
point the reader to section II.B.5.b.1. of
this final rule with comment period for
an example of this issue.
We believe that our CY 2011
refinements of equipment minutes for
new and revised, and potentially
misvalued codes most accurately reflect
typical use of resources required to
furnish PFS services to Medicare
beneficiaries. We will continue to work
to improve the accuracy of the
equipment minutes and will address
any further improvements in future
rulemaking.
(2) Supply and Equipment Items
Missing Invoices
When clinically appropriate, the
AMA RUC generally recommends the
use of supply and equipment items that
already exist in the direct PE database
as inputs for new, revised, and
potentially misvalued codes. Some
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recommendations include supply or
equipment items that are not currently
in the direct PE database. In these cases,
the AMA RUC has historically
recommended a new item be created
and has facilitated CMS’ pricing of that
item by working with the specialty
societies to provide sales invoices to us.
We appreciate the contributions of the
AMA RUC in that process.
Despite the assistance of the AMA
RUC for CY 2011, we did not receive
adequate information for pricing the
following new supply items included in
the AMA RUC’s CY 2011 direct PE
recommendations: SC098 (Catheter,
angiographic, Berman); SD251 (Sheath
Shuttle (Cook); SD255 (Reentry Device
(Frontier, Outback, Pioneer); SD257
(Tunneler); and SD258 (Vacuum Bottle).
Therefore, for CY 2011, these supply
items had no price inputs associated
with them in the direct PE database. In
the CY 2011 PFS final rule (75 FR
73351), we noted that we would
consider any newly submitted
information for these items as part of
our annual supply and equipment price
update process.
Comment: One commenter pointed
out that the ‘‘vacuum bottle’’ already
has an established supply code, SD 144,
and is referred to as ‘‘canister, vacuum,
pleural (w-drainage line).’’ The
commenter also claimed that invoice
pricing for the Sheath Shuttle (Cook)
had already been submitted to CMS.
Response: We agree with the
commenter’s assessment regarding the
vacuum bottle being captured by the
existing supply code SD144, and we
have subsequently removed SD258 from
the direct PE database. The only
information we have received regarding
the Sheath Shuttle was a page from the
vendor’s catalog that described the item.
However, that information did not
include a price, so we were unable to
use that information in pricing the
supply input.
We remind stakeholders that we
established a process that allows the
public to submit requests for updates to
supply price inputs or equipment price
or useful life inputs in the CY 2011 PFS
final rule with comment period (75 FR
73205 through 73207). As part of this
established process, we ask that requests
be submitted as comments to the PFS
final rule with comment period each
year, subject to the deadline for public
comments applicable to that rule.
Alternatively, stakeholders may submit
requests to CMS on an ongoing basis
throughout a given calendar year to
PE_Price_Input_Update@cms.hhs.gov.
Requests received by the end of a
calendar year will be considered in
rulemaking during the following year.
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We refer readers to the description
available in the CY 2011 PFS final rule
(75 FR 73206) that details the minimum
information we request that
stakeholders provide in order to
facilitate our review and preparation of
issues for the proposed rule.
c. Code-Specific Direct PE Inputs
(1) CT Abdomen and Pelvis
For CY 2011, AMA CPT created a
series of new codes that describe
combined CTs of the abdomen and
pelvis. Prior to 2011, these services
would have been billed using multiple
stand-alone codes for each body region.
The new codes are: 74176 (Computed
tomography, abdomen and pelvis;
without contrast material); 74177
(Computed tomography, abdomen and
pelvis; with contrast material); and
74178 (Computed tomography,
abdomen and pelvis; without contrast
material in one or both body regions,
followed by with contrast material(s)
and further sections in one or both body
regions.)
Comment: One commenter stated that
there were discrepancies between the
inputs for these codes and the AMA
RUC recommendations that were not
addressed as refinements in the CY 2011
PFS final rule with comment period.
Specifically, the commenter suggested
that CMS did not include a power
injector recommended by the RUC.
Another commenter stated that the
clinical labor type in the codes should
be a ‘‘CT technologist’’ (L046A) instead
of a ‘‘Radiologic Technologist’’ (L041B).
Response: We have reexamined the
CY 2011 AMA RUC direct PE
recommendations for these codes and
confirmed that the RUC
recommendation we received does not
include power injector as an input for
these codes. We also confirmed that the
RUC recommendation included labor
code ‘‘Radiologic Technologist’’ (L041B)
for these codes. We also confirmed that
the information the specialty society
presented to the RUC also included the
‘‘Radiologic Technologist’’ as the
clinical labor time for the service.
However, we note that both the RUC
and other commenters now believe the
labor type was included in error, and all
similar codes include the ‘‘CT
technologist’’ (L046A) as the
appropriate labor type, including the
codes that describe a CT of the abdomen
and a CT of the pelvis independently.
Therefore, we consider the labor code
included with the recommendation to
be a technical oversight, and we have
amended the labor category in each of
the three codes to include a ‘‘CT
technologist’’ (L046A).
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Comment: One commenter stated that
each of these codes is missing the film
jacket and CD supply inputs which are
proxies for digital storage of images.
Response: We did not accept the film
jacket as a disposable supply item
because film jackets are not disposable/
consumable supplies. We did not
incorporate the CD as a supply item
since the codes also included x-ray film,
which can also be a proxy for digital
image storage. We mistakenly omitted
these refinements from the list of
refinements in the CY 2011 PFS final
rule with comment period.
After consideration of these
comments, for CY 2012, we are
finalizing the direct PE inputs, with the
labor category refinement, for CPT codes
74176, 74177, and 74178.
(2) Endovascular Revascularization
In the CY 2011 PFS final rule with
comment period (75 FR 73351), we
explained our refinements of the supply
input recommendations from the AMA
RUC for CPT codes describing certain
endovascular revascularization services.
The recommendations included two or
three high-cost stents for each of the
following six CPT codes: 37226
(Revascularization, femoral/popliteal
artery(s), unilateral; with transluminal
stent placement(s); 37227
(Revascularization, femoral/popliteal
artery(s), unilateral; with transluminal
stent placement(s) and atherectomy);
37230 (Revascularization, tibial/
peroneal artery, unilateral, initial vessel;
with transluminal stent placement(s));
37231 (Revascularization, tibial/
peroneal artery, unilateral, initial vessel;
with transluminal stent placement(s)
and atherectomy); 37234
(Revascularization, tibial/peroneal
artery, unilateral, each additional vessel;
with transluminal stent placement(s)
(List separately in addition to code for
primary procedure)); and 37235
(Revascularization, tibial/peroneal
artery, unilateral, each additional vessel;
with transluminal stent placement(s)
and atherectomy (List separately in
addition to code for primary
procedure)).
Given the complex clinical nature of
these services, their new pricing in the
nonfacility setting under the PFS, and
the high cost of each stent, we were
concerned that inclusion of two or three
stents could overestimate the number of
stents used in the typical office
procedure that would be reported under
one of the CPT codes. Therefore, we
examined CY 2009 hospital OPPS
claims data for the combinations of
predecessor codes that would have
historically been reported for each case
reported in under CY 2011 under a
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single comprehensive code. Because of
the OPPS device-to-procedure claims
processing edits, all prior cases would
have included a HCPCS C-code for at
least one stent on the claim for the case.
Based on our analysis of these data, we
determined that for each new CY 2011
comprehensive code, the predecessor
code combinations would have used
only one stent in 65 percent or more of
the cases. We had no reason to believe
that when these new CPT codes were
reported for procedures performed in
the nonfacility setting, the typical
patient would receive more than the one
stent typically used in the hospital
outpatient setting. Therefore, we refined
the CY 2011 AMA RUC
recommendations to include one stent
in the direct PE inputs for each of the
six endovascular revascularization stent
insertion codes, including the add-on
codes. These refinements were reflected
in the final CY 2011 PFS direct PE
database.
Comment: One commenter asserted
that the CMS analysis of the OPPS data
was flawed because the predecessor
codes included treatments of all
vascular territories instead of only the
lower extremities described by the new
codes. Additionally, the commenter
argued that hospital payment does not
depend on correctly coding the number
of stents, so the claims data are probably
inaccurate. In order to account for the
latter possibility, the commenter
reported conducting a review of similar
claims data that excluded all hospitals
that reported only one unit for stents for
all of their claims. After examining that
data, the commenter reported that the
percentage of one stent dropped ‘‘closer
to 50 percent.’’ The commenter argued
that this analysis, combined with the
former assertion regarding the
limitations of anatomic non-specificity,
invalidates the CMS’ analysis that
supported the refinement of the RUCrecommended direct PE inputs.
Therefore, the commenter argued that
CMS should accept the RUC
recommendation without refinement
and use the quantity of stents originally
recommended in the direct PE database.
Response: As we stated in the CY
2011 PFS final rule (75 FR 73351), we
have no reason to believe that more than
one stent is typically used in furnishing
the services reported under one of the
CPT code in the nonfacility setting.
While the commenter did not submit
detailed results from the data used in
reaching conclusions, we believe it
important to note that even after
reviewing preferred data, the
commenter reported results that
continued to indicate that one stent was
used in at least half of the cases. While
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we appreciate the commenter’s
arguments regarding the potential
differences between the stents required
in the lower extremities and the pooled
data reported by hospitals in the
predecessor codes, we believe the
possibility of such disparity is likely
more than offset by the difference in
typical patient acuity in the hospital
outpatient and nonfacility settings.
Finally, we note that neither the AMA
RUC nor the medical specialty society
that reports the highest utilization of
these codes submitted comments in
opposition to refinement of these direct
PE inputs.
Comment: One commenter stated that
there were discrepancies between the
clinical labor inputs for these codes and
the AMA RUC recommendations that
were not addressed as refinements in
the CY 2011 PFS final rule with
comment period.
Response: We have reexamined the
CY 2011 AMA RUC direct PE
recommendations for these codes and
confirmed that the labor minutes
associated with the codes in the direct
PE database match the AMA RUC
recommendations regarding clinical
labor inputs, which we accepted
without refinement.
Comment: One commenter alerted
CMS that the minutes allocated for two
particular equipment items (a printer
and a stretcher) had been inverted in
three of these codes.
Response: We appreciate the
commenter’s informing us of the
inverted minutes. We made a proposal
to correct these inputs in the CY 2012
PFS proposed rule, and we are
finalizing that correction in section
II.A.3.a. of this final rule with comment
period.
After consideration of all comments
received, we are finalizing the direct PE
inputs, as amended in section II.A.3.a.
of this final rule with comment period,
for these codes for CY 2012.
(3) Nasal/Sinus Endoscopy
The CY 2011 AMA RUC
recommendation for direct PE inputs for
CPT code 31295 (Nasal/sinus
endoscopy, surgical; with dilation of
maxillary sinus ostium (e.g., balloon
dilation), transnasal or via canine fossa),
included irregular supply and
equipment inputs. The AMA RUC
recommended two similar, new supply
items, specifically ‘‘kit, sinus surgery,
balloon (maxillary, frontal, or
sphenoid)’’ and ‘‘kit, sinus surgery,
balloon (maxillary)’’ as supply inputs
with a quantity of one-half for each
item. In the CY 2011 PFS final rule with
comment period (75 FR 73351), we
explained that we believed that this
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recommendation was intended to reflect
an assumption that each of these
distinct supplies is used in
approximately half of the cases when
the service is furnished. We noted that,
in general, the direct PE inputs should
reflect the items used when the service
is furnished in the typical case.
Therefore, the quantity of supply items
associated with a code should reflect the
actual units of the item used in the
typical case, and not be reflective of any
estimate of the proportion of cases in
which any supply item is used. We also
noted, however, that fractional inputs
are appropriate when fractional
quantities of a supply item are typically
used, as is commonly the case when the
unit of a particular supply reflects the
volume of a liquid supply item instead
of quantity.
Upon receipt of these
recommendations, we requested that the
AMA RUC clarify the initial
recommendation by determining which
of these supply items would be used in
the typical case. The AMA RUC
recommended that the supply item ‘‘kit,
sinus surgery, balloon (maxillary,
frontal, or sphenoid)’’ be included in the
inputs for the code. We considered that
recommendation, but we believed the
item ‘‘kit, sinus surgery, balloon
(maxillary)’’ to be more clinically
appropriate based on the description of
CPT code 32195.
The AMA RUC recommendation for
equipment inputs for the same code
(CPT code 31295) included a parallel
irregularity by distributing half of the
equipment minutes to each of two
similar pieces of equipment, one
existing and one new: ‘‘endoscope,
rigid, sinoscopy’’ (ES013) and
‘‘fiberscope, flexible, sinoscopy’’ (ES035
and new for CY 2011). We believed that
this recommendation was intended to
reflect an assumption that each of these
distinct pieces of equipment is used in
approximately half of the cases in which
the service is furnished. Again, we
noted that, in general, the direct PE
inputs should reflect the items used
when the service is furnished in the
typical case. Therefore, the equipment
time inputs associated with a code
should reflect the number of minutes an
equipment item is used in the typical
case, and not be distributed among a set
of equipment items to reflect an
estimate of the proportion of cases in
which a particular equipment item
might be used. Upon review of these
items, we believed the new piece of
equipment, ‘‘fiberscope, flexible,
sinoscopy’’ to be more clinically
appropriate based on the description of
CPT code 32195. We refined the CY
2011 AMA RUC direct PE
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recommendations to conform to these
determinations.
Comment: Two commenters claimed
that CMS had misunderstood the
recommendation of the AMA RUC, that
two kits are typically used each time
that the maxillary sinus surgery is
furnished, and that both the rigid and
the flexible scope are used in furnishing
the service. One of commenters also
suggested that the service requires the
use of a light pipe so the direct PE
database should include a light pipe for
the codes. Both commenters also
suggested that CMS institute PE RVUs
that directly reimburse the costs of
furnishing the service as calculated by
the commenters.
As part of their CY 2012
recommendations, the AMA RUC
provided a new recommendation
regarding the disposable sinus surgery
kits included as direct PE supply inputs
for each of these three codes. When
developing direct PE input
recommendations for these new codes,
the AMA RUC believed that the codes
would be typically billed in one unit per
patient encounter. Following
implementation of these codes for
Medicare purposes at the start of CY
2011, the RUC received reports that
multiple units of services were being
reported in the same patient encounter
and that corresponding number of kits
was not utilized. The RUC reported this
information to CMS in conjunction with
a request for preliminary claims data.
The RUC then examined partial year
sample claims data that overwhelmingly
demonstrated each of the codes was
typically billed with another code in the
family and more often billed in
multiples of three than singularly. Using
this information to corroborate the
reports the RUC had previously
received, the RUC submitted a refined
recommendation for CMS to consider
for CY 2012. The new recommendation
requests that CMS remove the
disposable sinus surgery kits from each
of the codes for CY 2012 and implement
separately billable alpha-numeric
HCPCS codes when possible to allow
practitioners to be paid the cost of the
disposable kits per patient encounter
instead of per CPT code.
Response: We agree with the RUC that
only one kit is used when typically
furnishing the maxillary sinus
procedure. We also continue to believe
that in the typical case only one of the
scopes is used. Neither commenter
submitted evidence to support their
claims that more than one kit or scope
is required to furnish these services. In
response to the commenter’s statement
regarding the missing input for a light
pipe, we confirmed that the RUC
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recommendations and the CY 2011
direct PE database include minutes
allocated to ‘‘light, fiberoptic headlight
w-source’’ equipment (EQ170). We do
not understand why the commenter
requests that minutes should be
allocated for an additional light source.
We appreciate and agree with the
RUC’s concern that the CY 2011
recommendations reflect an incorrect
assumption about the number of
services furnished per disposable sinus
surgery kit used. We have considered
the RUC’s recommendation to remove
the sinus surgery kits from the codes
immediately and establish separately
payable alpha-numeric HCPCS codes to
use to report using the kits in furnishing
the services described by these codes,
and we agree that it provides one
potential long-term solution to the
problem with the high-cost disposable
supply inputs for these particular codes.
However, the RUC’s solution presents a
series of potential problems that we
have addressed previously in the
context of the broader challenges
regarding our ability to price high cost
disposable supply items. For the most
recent discussion of this issue, we direct
the reader to our discussion in the CY
2011 PFS final rule with comment
period (75 FR 73251). However, we will
consider the recommendation of the
RUC regarding these and similar supply
items during preparation for future
rulemaking.
For CY 2012, we do not believe it
would be appropriate to remove these
items as supply inputs for these codes
without providing an alternative means
for paying practitioners for the resources
associated with furnishing the related
services. At the same time, however, we
do not believe that it would be
appropriate to maintain supply inputs
that are based on an incorrect
assumption about the relationship
between how a service is furnished and
how it is reported. Given the recent
recommendation from the RUC, as well
as our concurring interpretation of
preliminary claims data for these codes,
we believe that modifying the supply
inputs for these codes is the most
appropriate means for achieving
accurate payment for CY 2012.
Recognizing that these codes are
typically billed in units of two, we
believe that reducing the sinus surgery
kit supply quantity to one-half for each
of the codes will best reflect the number
of kits used when the services are
typically furnished. As part of our
initial refinements, we only included
the sinus surgery kit specific to the
maxillary sinus in CPT code 32195.
Since we now understand that the nonspecific kits can be used when
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furnishing more than one service to the
same beneficiary on the same day, we
believe that it would be appropriate to
include one-half non-specific sinussurgery kit for each code, including CPT
code 32195.
After consideration of both the public
comments and the recommendations of
the AMA RUC, we are altering the direct
PE inputs for these codes as follows.
The ‘‘kit, sinus surgery, balloon
(maxillary, frontal, or sphenoid)’’
(SA106) will be included in the direct
PE database at the quantity of one-half
for each of the three CPT codes: 31295,
31296, and 31297. The ‘‘kit, sinus
surgery, balloon (maxillary)’’ (SA107)
will be removed as an input for 31295
in the direct PE database. We are not
allocating equipment for an additional
scope or an additional light source for
any of the codes. However, we are not
finalizing the direct PE inputs for 31295,
31296, or 31297 for CY 2012. Instead,
we will keep these direct PE inputs as
interim final for CY 2012. We seek
additional public comments regarding
the appropriate direct PE inputs for
these codes and we will continue to
consider the AMA RUC’s solution for
future rulemaking.
(4) Insertion of Intraperitoneal Catheter
For CY 2011, CPT created a new code
to describe percutaneous procedures:
49418 (Insertion of tunneled
intraperitoneal catheter (e.g., dialysis,
intraperitoneal chemotherapy
instillation, management of ascites),
complete procedure, including imaging
guidance, catheter placement, contrast
injection when performed, and
radiological supervision and
interpretation; percutaneous).
Comment: Two commenters stated
that CMS had not addressed some of the
direct PE input recommendations for
CPT Code 49418 (Insertion of tunneled
intraperitoneal catheter, complete
procedure). In particular, the
commenters suggested that a film jacket
and a CD approved by the RUC as
disposable supply inputs for the codes
were not included in the direct PE
database but were not were not
addressed as refinements in the CY 2011
PFS final rule with comment period.
Another commenter suggested that there
were discrepancies between the clinical
labor inputs for these codes and the
AMA RUC recommendations that were
not addressed as refinements in the CY
2011 PFS final rule with comment
period.
Response: We did not accept the film
jacket as a disposable supply item
because film jackets are not disposable/
consumable supplies. This refinement
was included in the CY 2011 PFS final
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rule (75 FR 73362). We did not
incorporate the CD as a supply item for
49418 since the code also included xray film, which can also be a proxy for
digital image storage. We mistakenly
omitted this refinement from the list of
refinement in the CY 2011 PFS final
rule. We have reexamined the CY 2011
AMA RUC direct PE recommendations
for these codes and confirmed that the
labor minutes associated with the codes
in the direct PE database match the
AMA RUC recommendations regarding
clinical labor inputs, which we accepted
without refinement.
In addition to the public comments,
we have reviewed the inputs for this
code and are concerned with one of the
disposable supplies included in the
recommendation. We accepted an item
called ‘‘Y-set connection tubing’’
(SD260). The invoice submitted with the
recommendation describes an item that
is used to replace a plastic catheter
connecter included with a disposable
flex-neck catheter. We are asking for
public comment regarding the accuracy
of this item.
We are maintaining the direct PE
inputs for CPT code 49418 for CY 2012,
but since we are seeking public
comment regarding a particular supply
item, we are keeping the direct PE
inputs as interim for CY 2012.
(5) In Situ Hybridization Testing
We note that we also received
comments on the interim final direct PE
inputs for CPT codes 88120
(Cytopathology, in situ hybridization
(e.g., FISH), urinary tract specimen with
morphometric analysis, 3–5 molecular
probes, each specimen; manual) and
88121 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis,
3–5 molecular probes, each specimen;
using computer-assisted technology).
We addressed those comments in CY
2012 PFS proposed rule and again in
section II.B.5.b. of this final rule. We
refer readers there for additional
discussion of these codes. As we note in
that section, for CY 2012 we are
maintaining the current direct PE inputs
for CPT codes 88120 and 88121, but
they will remain interim and open for
public comment.
(6) External Mobile Cardivascular
Telemetry
In the CY 2011 PFS final rule with
comment period, after consideration of
the public comments we received, we
established a national price for CPT
code 93229 (Wearable mobile
cardiovascular telemetry with
electrocardiographic recording,
concurrent computerized real time data
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analysis and greater than 24 hours of
accessible ECG data storage (retrievable
with query) with ECG-triggered and
patient selected events transmitted to a
remote attended surveillance center for
up to 30 days; technical support for
connection and patient instructions for
use, attended surveillance, analysis and
physician prescribed transmission of
daily and emergent data reports) instead
of maintaining the code as contractorpriced as we had proposed for CY 2011.
We adopted the AMA RUC’s
recommendations for the clinical labor
and supply inputs, and utilized price,
utilization, and useful life information
provided by commenters as equipment
inputs for the cardiac telemetry
monitoring device worn by the patient.
In developing PE RVUS for this service,
we classified the costs associated with
the centralized monitoring equipment,
including the hardware and software,
workstation, webserver, and call
recording system, as indirect costs.
Comment: We received comments
objecting to the manner in which CPT
93229 was nationally priced. These
objections included reiterations of
earlier comments received on the CY
2011 PFS proposed rule that we should
treat the centralized hardware and
software as a direct cost similar to the
treatment of the cardiac telemetry
monitoring device worn by the patient
and we should incorporate a new PE/HR
value into the methodology for services
such as remote cardiac monitoring.
Response: As we noted in the CY
2011 PFS final rule, we believe it is
more appropriate to classify the costs
associated with the centralized
monitoring equipment, including the
hardware and software, workstation,
webserver, and call recording system, as
indirect costs since it is difficult to
allocate those costs to services furnished
to individual patients in a manner that
adequately reflects the number of
patients being tested. As we also
indicated in the CY 2011 PFS final rule,
it would be inappropriate to deviate
from our standard PFS PE methodology
to adopt a PE/HR that is specific to CPT
code 93229 or any other set of cardiac
monitoring codes based on data from
two telemetry providers, from a subset
of services provided by certain specialty
cardiac monitoring providers, or from a
certain group of specialty providers that
overall furnish only a portion of cardiac
monitoring services, nor to change our
established indirect PE allocation
methodology. We believe the current PE
methodology appropriately captures the
relative costs of these services in setting
their PE RVUs, based on the conclusion
we have drawn following our
assessment of the centralized
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monitoring system that is especially
characteristic of services such as CPT
code 93229. For these reasons, after
careful consideration of the comments
received on this issue, we continue to
disagree with commenters who believe
we should treat the centralized
hardware and software as a direct cost
and that we should incorporate a new
PE/HR value into the methodology for
services such as remote cardiac
monitoring. We are finalizing, without
modification, the development of PE
RVUs for CPT 93229.
3. Finalizing CY 2011 Interim Final and
CY 2012 Proposed Malpractice RVUs
a. Finalizing CY 2011 Interim Final
Malpractice RVUs
Consistent with our malpractice
methodology described in section II.C.1.
of this final rule with comment period,
for the CY 2011 PFS final rule, we
developed malpractice RVUs for new
codes and adjusted malpractice RVUs
for revised codes by scaling the
malpractice RVUs of the CY 2011 new/
revised codes for differences in work
RVUs between a source code and the
new/revised codes. For CY 2011 we
adopted the AMA RUC-recommended
source code crosswalks for all new and
revised codes on an interim final basis.
Comment: Commenters supported the
adoption of the AMA RUCrecommended malpractice crosswalks
for the CY 2011 new and revised codes
and encouraged CMS to continue to
adopt the AMA RUC recommendations
in future rulemaking.
Response: We thank commenters for
their support of the CY 2011 interim
final malpractice crosswalks. We will
continue to consider the AMA RUC–
recommended malpractice crosswalks
and public comments when determining
the appropriate risk-of-service for new/
revised codes. For CY 2012 we are
finalizing, without modification, the CY
2011 interim final malpractice source
code crosswalks. The CY 2011 interim
final malpractice crosswalk, finalized
for CY 2012, is available at the CMS
Web site at: https://www.cms.gov/
PhysicianFeeSched/PFSFRN/list.asp.
We did not receive any comments to
the CY 2011 PFS final rule with
comment period disagreeing with the
malpractice crosswalk for any of the CY
2011 new and revised codes. However,
we note that we did receive a comment
to the CY 2012 PFS proposed rule for
CPT codes 88120 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis,
3–5 molecular probes, each specimen;
manual) and 88121 (Cytopathology, in
situ hybridization (e.g., FISH), urinary
tract specimen with morphometric
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analysis, 3–5 molecular probes, each
specimen; using computer-assisted
technology); both CPT codes had CY
2011 interim final PE, work, and
malpractice RVUs. The commenter
requested that we increase the physician
work and malpractice RVUs assigned to
CPT code 88121 to match the physician
work and malpractice RVUs assigned to
CPT code 88120. As discussed in detail
in section II.B.5. of this final rule with
comment period, we are holding the PE,
work, and malpractice RVUs for CPT
code 88120 and 88121 as interim for CY
2012, pending re-review by the AMA
RUC.
Additionally, we received a comment
to the CY 2011 PFS final rule requesting
that we reevaluate the malpractice risk
factor for a number of largely pediatric
cardiothoracic surgery CPT codes. These
CPT codes were not open for comment
for CY 2011, however we addressed this
malpractice comment in the CY 2012
PFS proposed rule (76 FR 42814), and
it is discussed in greater detail in
section II.A.3.d. of this final rule with
comment period.
b. Finalizing CY 2012 Proposed
Malpractice RVUs, Including
Malpractice RVUs for Certain
Cardiothoracic Surgery Services
As described in the Five Year Review
(76 FR 32469) for CPT codes with work
RVU changes included in the Fourth
Five-Year Review, the malpractice
source code for nearly all reviewed
codes was the code itself (a 1 to 1
crosswalk). For these CPT codes, we
calculated the revised malpractice RVUs
by scaling the current (CY 2011)
malpractice RVU by the percent
difference in work RVU between the
current (CY 2011) work RVU and the
proposed work RVU. However, there
were three CPT codes included in the
Five Year Review that were previously
contractor priced and did not have
current (CY 2011) work RVUs—CPT
codes 33981 (Replacement of
extracorporeal ventricular assist device,
single or biventricular, pump(s), single
or each pump), 33982 (Replacement of
ventricular assist device pump(s);
implantable intracorporeal, single
ventricle, without cardiopulmonary
bypass), and 33983 (Replacement of
ventricular assist device pump(s);
implantable intracorporeal, single
ventricle, with cardiopulmonary
bypass). For all three CPT codes, we
applied the AMA RUC-recommended
malpractice crosswalks to obtain the
appropriate malpractice RVUs. The
crosswalk source code for CPT code
33981 was CPT code 33976 (Insertion of
ventricular assist device; extracorporeal,
biventricular), and the crosswalk source
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73187
for CPT codes 33982 and 33983 was
CPT code 33979 (Insertion of ventricular
assist device, implantable
intracorporeal, single ventricle).
Consistent with the malpractice
methodology, the malpractice RVUs for
these three newly-valued CPT codes
were developed by adjusting the
malpractice RVU of the source codes for
the difference in work RVU between the
source code and the newly-valued
codes.
We received no comments on the
malpractice crosswalks included in the
Five-Year Review. We are finalizing the
Five-Year Review malpractice
crosswalks without modification for CY
2012.
In the CY 2012 PFS proposed rule
there were a number of codes for which
we reviewed the physician work and
practice expense. Like the Five-Year
Review, for these CPT codes the source
code for each code was the code itself
(a 1-to-1 crosswalk). Therefore, we
calculated the revised malpractice RVUs
for these codes by scaling the current
(CY 2011) malpractice RVU by the
percent difference in work RVU
between the current (CY 2011) work
RVU and the proposed work RVU (76
FR 42813).
In addition to the scaling of
malpractice RVUs to account for the
proportionate difference between
current and proposed work RVUs, there
were 19 cardiothoracic surgery codes for
which we proposed to scale the
malpractice RVUs to account for the
proportionate difference between the
current and proposed revised specialty
risk factor (76 FR 42813). These codes
and their short descriptors are listed in
Table 17. We assign malpractice RVUs
to each service based upon a weighted
average of the malpractice risk factors of
all specialties that furnish the service.
For the CY 2010 review of malpractice
RVUs, we used CY 2008 Medicare
claims data on allowed services to
establish the frequency of a service by
specialty. For a number of
cardiothoracic surgery CPT codes
representing major open heart
procedures performed primarily on
neonates and infants, CY 2008 Medicare
claims data showed zero allowed
services. Therefore, our contractor set
the number of services to 1, and
assigned a risk factor according to the
average risk factor for all services that
do not explicitly have a separate
technical or professional component
(average risk factor = 1.95). In the CY
2010 PFS final rule with comment
period, we published interim final
malpractice RVUs for these codes
calculated using the average physician
risk factor, and finalized them in the CY
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We also proposed to scale the
malpractice RVUs to reflect a change in
risk factor for CPT code 32442 (Removal
of lung, total pneumonectomy; with
resection of segment of trachea followed
by broncho-tracheal anastomosis (sleeve
pneumonectomy)). In the CY 2010
review of malpractice RVUs we assigned
CPT code 32442 the pulmonary disease
risk factor (2.09) and published the
interim final malpractice RVU
calculated from this risk factor in the CY
2010 PFS final rule with comment
period. This value was finalized in the
CY 2011 PFS final rule with comment
period. Since finalizing this value,
stakeholders have suggested that a
blended risk factor of thoracic surgery
(6.49) and general surgery (5.91) would
be more appropriate for this service. As
described in the CY 2010 PFS final rule
with comment period (74 FR 61760), we
do not use a blended risk factor for
services with Medicare utilization under
100; instead, we use the malpractice risk
factor of the specialty that performs the
given service the most (the dominant
specialty). As CPT code 32442 has
Medicare utilization well below the 100
occurrences threshold, and current
Medicare claims data show that the
dominant specialty for CPT code 32442
is thoracic surgery, we believed that the
thoracic surgery risk factor is the
appropriate risk factor for this service.
Adjusting the malpractice RVU to reflect
the thoracic surgery risk factor rather
than the pulmonary disease risk factor
resulted in a malpractice RVU of 13.21
for CPT code 32442. Therefore, we
proposed a malpractice RVU of 13.21 for
CPT code 32442 for CY 2012.
Comment: Commenters noted their
appreciation of our review and revisions
to these 19 cardiothoracic surgery
services. Commenters stated that setting
the risk factor to the all physician
average penalized the providers of these
procedures, and expressed concern that
this will occur again unless CMS
considers using an assigned specialty
for CPT codes with fewer than 100
claims per year. Commenters believe
that it would be prudent to re-examine
the use of claims data to identify the
appropriate specialty for services with
less than 100 claims.
Response: We appreciate commenters
support for our proposal to revise the
malpractice RVUs for certain
cardiothoracic surgery services. We note
commenters’ concern with the
malpractice methodology as it relates to
services with less than 100 claims and
will consider this recommendation for
future rulemaking. We received no
comments on the 1-to-1 crosswalks
described previously for CPT codes with
work and practice expense revisions in
the CY 2012 PFS proposed rule. For CY
2012, we are finalizing without
modification, the proposed crosswalks,
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2011 PFS final rule with comment
period. However, since publication of
the CY 2010 PFS final rule with
comment period, stakeholders
expressed concern that the average risk
factor was not appropriate for these
services, and that a cardiac surgery risk
factor would be more appropriate
(cardiac surgery risk factor = 6.93).
While these CPT codes continued to
have little to no Medicare claims data,
upon clinical review we agreed that
these CPT codes represent cardiac
surgery services and that the
malpractice RVUs should be calculated
using the cardiac surgery risk factor.
Accordingly, we proposed to scale the
malpractice RVUs for these CPT codes
to reflect the proportionate difference
between the average risk factor and the
cardiac surgery risk factor.
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
73189
product of the CY 2006 RVUs for these
DXA codes, the CY 2006 CF, and the
geographic adjustment for the relevant
payment year). Because the statute
specifies a payment calculation for these
services for CY s 2010 and 2011 as
described previously, for those years we
implemented the payment provision by
imputing RVUs for these services that
would provide the specified payment
amount for these services when
multiplied by the current year’s
conversion factor.
As discussed in the CY 2012 PFS
proposed rule (76 FR 42809 and 42810),
for CY 2012, the payment rate for CPT
codes 77080 and 77082 will be based
upon resource-based, rather than
imputed, RVUs, and the current year’s
conversion factor. The CY 2012 work,
PE, and malpractice RVUs for these
codes are shown in Table 18, CY 2012
RVUs for DXA CPT Codes 77080 and
77082, as well as in Addendum B of this
final rule with comment period.
In addition to temporarily changing
the payment rate for the two DXA CPT
codes, section 3111(b) of the Affordable
Care Act also authorizes the Secretary to
enter into agreement with the Institute
of Medicine of the National Academies
to conduct a study on the ramifications
of Medicare payment reductions for
dual-energy x-ray absorptiometry (as
described in section 1848(b)(6) of the
Act) during years 2007, 2008, and 2009
on beneficiary access to bone mass
density tests. This study has not yet
been conducted. In the absence of this
study, we have requested that the AMA
RUC review CPT codes 77080 and
77082 during CY 2012.
2011 interim final RVUs or CY 2012
proposed RVUs that are not specifically
discussed in this final rule with
comment period, we are finalizing for
CY 2012, without modification, the
interim final or proposed work and
malpractice RVUs and direct PE inputs.
Unless otherwise indicated, we agreed
with the time values recommended by
the AMA RUC or HCPAC for all codes
addressed in this section. The time
values for all codes appear on the CMS
Web site at: https://www.cms.gov/
PhysicianFeeSched/.
5. Other New, Revised, or Potentially
Misvalued Codes With CY 2011 Interim
Final RVUs or CY 2012 Proposed RVUs
Not Specifically Discussed in the CY
2012 Final Rule With Comment Period
1. Establishing Interim Final Work
RVUs for CY 2012
recommendations regarding physician
work values for new and revised CPT
codes. This section discusses the
families of clinically related CPT codes
where CMS disagreed with the AMA
RUC or HCPAC recommended
physician work RVU or time values for
a service for a CY 2012 new or revised
CPT code. The interim or interim final
physician work RVUs for all new and
revised codes, including those where
CMS agreed with the recommended
work RVU appear in Table 19 at the end
of this section. Unless otherwise
indicated, we agreed with the time
values recommended by the AMA RUC
or HCPAC for all codes addressed in
this section. The time values for all
codes appear on the CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/. We reviewed the
AMA RUC’s recommendations on
physician work and time for 156 CY
2012 new and revised CPT codes. Upon
clinical review, we agreed with the
4. Payment for Bone Density Tests
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Section 1848(b)(6) of the Act (as
amended by section 3111(a) of the
Affordable Care Act) changed the
payment calculation for dual-energy xray absorptiometry (DXA) services
described by two specified DXA CPT
codes for CY s 2010 and 2011. This
provision required payment for these
services at 70 percent of the product of
the CY 2006 RVUs for these DXA codes,
the CY 2006 CF, and the geographic
adjustment for the relevant payment
year.
Effective January 1, 2007, the CPT
codes for DXA services were revised.
The former DXA CPT codes 76075 (Dual
energy X-ray absorptiometry (DXA),
bone density study, one or more sites;
axial skeleton (e.g., hips, pelvis, spine));
For all other new, revised, or
potentially misvalued codes with CY
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C. Establishing Interim Final RVUs for
CY 2012
a. Code-Specific Issues
As previously discussed in section
III.A of this final rule with comment
period, on an annual basis, the AMA
RUC and HCPAC provide CMS with
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76076 (Dual energy X-ray
absorptiometry (DXA), bone density
study, one or more sites; appendicular
skeleton (peripheral) (for example,
radius, wrist, heel)); and 76077 (Dual
energy X-ray absorptiometry (DXA),
bone density study, one or more sites;
vertebral fracture assessment) were
deleted and replaced with new CPT
codes 77080, 77081, and 77082 that
have the same respective code
descriptors as the predecessor codes.
Section 1848(b) of the Act, as amended,
specifies that the revised payment
applies to two of the predecessor codes
(CPT codes 76075 and 76077) and ‘‘any
succeeding codes,’’ which are, in this
case, CPT codes 77080 and 77082.
As mentioned previously, section
1848(b) of the Act revised the payment
for CPT codes 77080 and 77082 during
CY 2010 and CY 2011. We provided for
payment in CY s 2010 and 2011 under
the PFS for CPT codes 77080 and 77082
at the specified rates (70 percent of the
as well as the proposed revisions to the
malpractice risk factors for the
cardiothoracic surgery services
described previously.
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molecular pathology services. These
CPT codes are new for CY 2012,
however they will not be valid for
Medicare purposes for CY 2012—For CY
2012 Medicare will continue to use the
current ‘‘stacking’’ codes for the
reporting and payment for these
services. These molecular pathology
codes appear in Addendum B to this
final rule with the procedure status
indicator of I (Not valid for Medicare
purposes. Medicare uses another code
for the reporting and payment for these
services).
CPT code 10061 was identified by the
AMA RUC Relativity Assessment
Workgroup through the HarvardValued—Utilization > 100,000 screen.
CPT code 10060 was identified as part
of this family to be reviewed. We
identified CPT code 11056 as part of the
MPC List screen.
After clinical review of CPT codes
10060 (Incision and drainage of abscess
(e.g., carbuncle, suppurative
hidradenitis, cutaneous or subcutaneous
abscess, cyst, furuncle, or paronychia);
simple or single) and 10061 (Incision
and drainage of abscess (e.g., carbuncle,
suppurative hidradenitis, cutaneous or
subcutaneous abscess, cyst, furuncle, or
paronychia); complicated or multiple)
we believe that the current work RVUs
of 1.22 and 2.45 respectively, accurately
reflect the work associated with these
services. Upon review, we found no
evidence that the work for these services
has changed.
For the Third Five-Year Review for
CY 2007, the HCPAC recommended
increasing the work RVU for CPT code
10060 from 1.17 to 1.50 because the
HCPAC believed the survey
methodology used for this code in the
original Harvard valuation was flawed.
In reviewing this code for the Third
Five-Year Review we compared the
specialty society survey times with the
Harvard-based times and found them
comparable (71 FR 37236). As such, we
found no grounds for increase, and
ultimately maintained the work RVU of
1.17 for this service (71 FR 69733). For
the CY 2010 PFS, the work RVU for CPT
code 10060 was increased to 1.22 based
on the redistribution of RVUs resulting
from the CMS policy to no longer
recognize the CPT consultation codes.
For CY 2012, the AMA RUC reviewed
the survey results from physicians who
perform this service. Citing the HCPAC
rationale and recommendation in the
Third Five-Year Review, the AMA RUC
recommended the survey median work
RVU of 1.50 for CPT code 10060 for CY
2012. We continue to believe that the
original valuation of the service was
appropriate, and since the work
associated with the procedure has not
changed, we believe that the current
work RVU of 1.22 should be
maintained. Therefore, we are assigning
a work RVU of 1.22 to CPT code 10060
on an interim final basis for CY 2012.
We reviewed CPT code 11056 (Paring
or cutting of benign hyperkeratotic
lesion (e.g., corn or callus); 2 to 4
lesions), and are accepting the HCPACrecommended work RVU of 0.50, the
survey 25th percentile value, on an
interim basis for CY 2012. We request
that the specialty society re-review CPT
code 11056 along with CPT codes 11055
(Paring or cutting of benign
hyperkeratotic lesion (e.g., corn or
callus); single lesion) and 11057 (Paring
or cutting of benign hyperkeratotic
lesion (e.g., corn or callus); more than 4
lesions) as part of the family. Therefore,
we are assigning a work RVU of 0.50 to
CPT code 11056 on an interim basis for
CY 2012, pending re-review of the
family of services.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
(1) Integumentary System: Skin,
Subcutaneous, and Accessory Structures
(CPT Codes 10060–10061, and 11056)
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(2) Integumentary System: Nails (CPT
codes 11719–11721)
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AMA RUC’s work RVU
recommendation for 106 CPT codes, or
68 percent. We reviewed the HCPAC’s
recommendations on physician work
and time for 8 CPT codes. Upon clinical
review, we agreed with the HCPAC’s
work RVU recommendation for 6 CPT
codes, or 75 percent.
We note that the AMA RUC also
reviewed over 100 CPT codes describing
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73191
code 11719 at that time, along with
G0127 (Trimming of dystrophic nails,
any number) which is crosswalked to
CPT code 11719.
After clinical review of CPT code
11720 (Debridement of nail(s) by any
method(s); 1 to 5.), and 11721
(Debridement of nail(s) by any
method(s); 6 or more.), we believe that
the current (CY 2011) work RVUs of
0.32 and 0.54 (respectively) continue to
accurately account for the work of these
services. The HCPAC also
recommended maintaining the current
(CY 2011) work RVUs for these services.
Therefore, we are assigning a work RVU
of 0.32 for CPT code 11720 and a work
RVU of 0.54 for CPT code 11721 on an
interim final basis for CY 2012.
For CY 2012, the CPT Editorial Panel
deleted 24 skin substitute codes and
established a 2-tier structure with 8 new
codes (CPT codes 15271 through 15278)
to report the application of skin
substitute grafts, which are
distinguished according to the anatomic
location and surface area rather than by
product description. Additionally, the
CPT Editorial Panel created a new addon code (CPT code 15777) to report
implantation of a biological implant for
soft ties reinforcement. For CY 2012, the
AMA RUC Relativity Assessment
Workgroup identified CPT codes 16020
and 16025 through its Different
Performing Specialty from Survey
screen.
For CY 2011, we created 2 HCPCS
codes, G0440 (Application of tissue
cultured allogeneic skin substitute or
dermal substitute; for use on lower limb,
includes the site preparation and
debridement if performed; first 25 sq cm
or less) and G0441 (Application of
tissue cultured allogeneic skin
substitute or dermal substitute; for use
on lower limb, includes the site
preparation and debridement if
performed; each additional 25 sq cm),
that are recognized for payment under
the PFS for the application of products
described by the codes to the lower
limb. These codes will be deleted for CY
2012. Providers reporting the
application of tissue cultured allogeneic
skin substitute or dermal substitutes to
the lower limb for payment under the
PFS in CY 2012 should report under the
appropriate new CPT code(s).
After clinical review of CPT code
15272 (Application of skin substitute
graft to trunk, arms, legs, total wound
surface area up to 100 sq cm; each
additional 25 sq cm wound surface area,
or part thereof (List separately in
addition to code for primary
procedure)), we believe that a work RVU
of 0.33 accurately reflects the work for
associated with this service. The AMA
RUC reviewed the survey results for
CPT code 15272 and recommended the
survey 25th percentile work RVU of
0.59 for this service.
However, we believe this value
overstates the work of this procedure
when compared to the base CPT code
15271 (Application of skin substitute
graft to trunk, arms, legs, total wound
surface area up to 100 sq cm; first 25 sq
cm or less wound surface area). We
believe that CPT code 15272 is similar
in intensity to CPT code 15341 (Tissue
cultured allogeneic skin substitute; each
additional 25 sq cm, or part thereof (List
separately in addition to code for
primary procedure)), and that the
primary factor distinguishing the work
of the two services is the intra-service
physician time. CPT code 15341 has a
work RVU of 0.50, 15 minutes of intraservice time, and an IWPUT of 0.0333.
CPT code 15272 has 10 minutes of intraservice time. Ten minutes of intraservice work at the same intensity as
CPT code 15341 is equal to a work RVU
of 0.33 (10 minutes × 0.0333 IWPUT =
0.33 WRVU). Therefore, we are
assigning a work RVU of 0.33 to CPT
code 15272 on an interim final basis for
CY 2012.
After clinical review of CPT code
15276 (Application of skin substitute
graft to face, scalp, eyelids, mouth, neck,
ears, orbits, genitalia, hands, feet, and/
or multiple digits, total wound surface
area up to 100 sq cm; each additional 25
sq cm wound surface area, or part
thereof (List separately in addition to
code for primary procedure)), we
believe that a work RVU of 0.50
accurately reflects the work associated
with this service. The AMA RUC
reviewed the survey results for CPT
code 15276 and recommended a work
RVU of 0.59 which corresponds to the
the AMA RUC’s recommended work
RVU for CPT code 15272. As discussed
previously, we are assigning an interim
final work RVU of 0.33 to CPT code
15272. We believe that the work
associated with CPT code 15276, which
describes work on the face, scalp,
eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, and/or multiple
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(3) Integumentary System: Repair
(Closure) (CPT Codes 15271–15278,
15777, 16020, 16025)
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We identified CPT code 11721 as part
of the MPC List screen. The AMA RUC
recommended that CPT codes 11721,
along with CPT code 11719 and 11720
be surveyed for CY 2012.
After reviewing the survey data, the
specialty society concluded that the
survey data for CPT code 11719
(Trimming of nondystrophic nails, any
number) was not reflective of the
service, and is resurveying CPT code
11719 for CY 2013. We will review CPT
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developing the procedure’s work value.
As described earlier in section III.A. of
this final rule with comment period, to
account for this overlap, we reduced the
pre-service evaluation and post-service
time by one-third. For CPT code 16020
we reduced the pre-service evaluation
time from 7 minutes to 5 minutes and
the post service time from 5 minutes to
3 minutes. For CPT code 16025 we
reduced the pre-service evaluation time
from 10 minutes to 7 minutes, and the
post-service time from 5 minutes to 3
minutes. A complete listing of the times
assigned to these CPT codes is available
on the CMS Web site at: https://
www.cms.gov/PhysicianFeeSched/.
In order to determine the appropriate
work RVUs for these services given the
time changes, we calculated the value of
the extracted time and subtracted it
from the AMA RUC-recommended work
RVUs. For CPT code 16020, we removed
a total of 4 minutes at an intensity of
0.0224 per minute, which amounts to
the removal of 0.09 of a work RVU. The
AMA RUC recommended a work RVU
of 0.80, the current (CY 2011) work
RVU. We are assigning an interim final
work RVU of 0.71, with refinement to
time, to CPT code 16020 for CY 2012.
For CPT code 16025, we removed a total
of 5 minutes at an intensity of 0.0224
per minute, which amounts to the
removal of 0.11 of a work RVU. The
AMA RUC recommended a work RVU
of 1.85, the current (CY 2011) work
RVU. We are assigning an interim final
work RVU of 1.74, with refinement to
time, to CPT code 16025 for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
For CY 2012, the CPT Editorial Panel
created CPT codes 26341 and 20517 to
describe a new technique for treating
Dupuytren’s contracture by injecting an
enzyme into the Dupuytren’s cord for
full finger extension and manipulation.
After clinical review of CPT code
26341 (Manipulation, palmar fascial
cord (ie, Dupuytren’s cord), post
enzyme injection (e.g., collagenase),
single cord), we believe that a work
RVU of 0.91 accurately reflects the work
associated with this service. The AMA
RUC reviewed the survey results for
CPT code 26341 and recommended a
work RVU of 1.66, which corresponds to
the survey 25th percentile value. We
believe the service described by CPT
code 26341 is analogous to CPT code
97140 (Manual therapy techniques (e.g.,
mobilization/manipulation, manual
lymphatic drainage, manual traction), 1
or more regions, each 15 minutes)
which has a work RVU of 0.43.
However, CPT code 97140 has no postservice visits (global period = XXX),
while CPT code 26341 includes 1 CPT
code 99212 level 2 office or outpatient
visit (global period = 010). To account
for this difference, we added the work
RVU of 0.48 for CPT code 99212, to the
work RVU of 0.43 for CPT code 97140,
for a total work RVU of 0.91. Therefore,
we are assigning an interim final work
RVU of 0.91 to CPT code 26341 for CY
2012.
For CY 2012 the CPT Editorial Panel
revised the descriptor for CPT code
29581, and also created CPT codes
29582, 29583, and 29584 to describe the
application of multi-layer compression
to the upper and lower extremities. The
CPT Editorial Panel and AMA RUC
concluded that the revisions to the
descriptor for CPT code 29581 were
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(4) Musculoskeletal: Hand and Fingers
(CPT Code 26341)
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(5) Musculoskeletal: Application of
Casts and Strapping (CPT Codes 29581–
29584)
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digits, is more intense than the work
associated with CPT code 15272, which
describes work on the trunk, arms, legs.
We believe that a work RVU of 0.50 for
CPT code 15276 accurately captures the
work associated with this service, and
establishes the appropriate relativity
between the services. Therefore, we are
assigning a work RVU of 0.50 to CPT
code 15276 on an interim final basis for
CY 2012.
CPT codes 16020 (Dressings and/or
debridement of partial-thickness burns,
initial or subsequent; small (less than 5
percent total body surface area)) and
16025 (Dressings and/or debridement of
partial-thickness burns, initial or
subsequent; medium (e.g., whole face or
whole extremity, or 5 percent to 10
percent total body surface area)) are
typically billed on the same day as an
E/M service. We believe some of the
activities conducted during the pre- and
post-service times of the procedure code
and the E/M visit overlap and, therefore,
should not be counted twice in
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73193
29584 (Application of multi-layer
compression system; upper arm,
forearm, hand, and fingers) all describe
similar services from a resource
perspective and should be valued
similarly. We believe CPT code 29581
(work RVU = 0.60) is valued
inappropriately high in relation to
newly created, surveyed, and HCPACreviewed CPT codes 29582, 29583, and
29584. We believe that the HCPAC
recommended work RVUs of 0.35 for
CPT code 29682, 0.25 for CPT code
29583, and 0.35 for CPT code 29584
accurately reflect the work associated
with these services. Additionally, we
believe that the clinical conditions
treated by CPT codes 29581 and 29583
are essentially the same, namely the
treatment of venus ulcers and
lymphedema. We recognize that there
will be mild differences and variation in
the application of a multi-layer
compression system to the upper
extremity versus the lower extremity,
which is accounted for in the intraservice times of the codes. As such, we
believe a work RVU of 0.25
appropriately accounts for the work
associated with CPT code 29581. We
believe that a survey that addresses all
4 CPT codes together as a family and
gathers responses from all clinicians
who furnish the services described by
CPT codes 29581 through 29584 would
help assure the appropriate gradation in
valuation of these 4 services. In sum, on
an interim basis for CY 2012 we are
assigning a work RVU of 0.25 to CPT
code 29581, a work RVU of 0.35 to CPT
code 29582, a work RVU of 0.25 to
29593, and a work RVU of 0.35 to CPT
code 29584.
CPT code 29826 was identified by the
AMA RUC Relativity Assessment
Workgroup through the Codes Reported
Together 75 percent or More screen.
This service is commonly performed
with CPT codes 29824, 29827 and
29828. In addition, as part of the Fourth
Five-Year Review, CMS identified
29826 through the Harvard-Valued—
Utilization > 30,000 screen.
Given that CPT code 29826
(Arthroscopy, shoulder, surgical;
decompression of subacromial space
with partial acromioplasty, with coracoacromial ligament (ie, arch) release,
when performed) is rarely performed as
a stand-alone procedure (less than 1
percent of the time), the American
Academy of Orthopaedic Surgeons
(AAOS) sent us a request to change the
global period from 090 to ZZZ. A global
surgical period of 090 is reflects a major
surgery with a 1-day preoperative
period and a 90-day postoperative
period included in the fee schedule
payment amount. A global surgical
period of ZZZ reflects a service that is
related to another service and is always
included in the global period of the
other service. These are often referred to
as ‘‘add-on’’ codes or services. We
agreed to change the global surgical
period for CPT code 29826, and CPT
code 29826 was surveyed and presented
as an add-on service with a ZZZ global
period.
After clinical review of CPT code
29826, we believe that the AMA RUCrecommended work RVU of 3.00, the
survey 25th percentile value, accurately
values the work associated with this
service. We are assigning a work RVU of
3.00 to CPT code 29826 on an interim
final basis for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
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(6) Musculoskeletal: Endoscopy/
Arthroscopy (CPT Codes 29826, 29880,
29881)
(7) Respiratory: Lungs and Pleura (CPT
Codes 32096–32854)
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editorial only, and the AMA RUC
related specialty society (Society for
Vascular Surgery) believed that
resurveying CPT code 29581 was not
necessary. As such, the AMA RUC
recommended ‘‘No Change’’ for CPT
code 29581. The new CPT codes 29582,
29583, and 29584 were surveyed
through the American Physical Therapy
Association (the expected dominant
providers of the services), and the
HCPAC reviewed the results and issued
recommendations to CMS for these 3
new CPT codes.
After clinical review, we believe that
CPT codes 29581 (Application of multilayer compression system; leg (below
knee), including ankle and foot), 29582
(Application of multi-layer compression
system; thigh and leg, including ankle
and foot, when performed), 29583
(Application of multi-layer compression
system; upper arm and forearm) and
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The CPT Editorial Panel reviewed the
lung resection family of codes for CY
2012 and deleted 8 codes, revised 5
codes and created 18 new codes to
describe new thoracoscopic procedures
and to clarify coding confusion between
lung biopsy and lung resection
procedures. For the wedge resection
procedures, the revisions were based on
three tiers; first, the approach,
thoracotomy or thoracoscopy; second,
the target to remove nodules or
infiltrates; and lastly the intent,
diagnostic or therapeutic (for nodules
only, all infiltrates will be removed for
diagnostic purposes).
After clinical review of CPT code
32096 (Thoracotomy, with diagnostic
biopsy(ies) of lung infiltrate(s) (e.g.,
wedge, incisional), unilateral), we
believe a work RVU of 13.75 accurately
reflects the work associated with this
service compared to other related
services. The AMA RUC reviewed the
survey results, compared the code to
other services, and concluded that the
survey 25th percentile work RVU of
17.00 appropriately accounts for the
work and physician time required to
perform this procedure. We determined
that the work associated with CPT code
32096 was similar in terms of physician
time and intensity to CPT code 44300
(Placement, enterostomy or cecostomy,
tube open (e.g., for feeding or
decompression) (separate procedure)).
We believe crosswalking to the work
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RVU of CPT code 44300 appropriately
accounts for the work associated with
CPT code 32096. Therefore, we are
assigning a work RVU of 13.75 for CPT
code 32096 on an interim final basis for
CY 2012.
After clinical review of CPT code
32097 (Thoracotomy, with diagnostic
biopsy(ies) of lung nodule(s) or mass(es)
(e.g., wedge, incisional), unilateral), we
believe a work RVU of 13.75 accurately
reflects the work associated with this
service compared to other related
services. The AMA RUC reviewed the
survey results, compared the code to
other services, and recommended the
survey 25th percentile work RVU of
17.00. We determined that the work
associated with CPT code 32096 was
similar to CPT code 32096, to which we
have assigned a work RVU of 13.75.
Therefore, we are assigning a work RVU
of 13.75 for CPT code 32097 on an
interim final basis for CY 2012.
After clinical review of CPT code
32098 (Thoracotomy, with biopsy(ies) of
pleura), we believe a work RVU of 12.91
accurately reflects the work associated
with this service compared to other
related services. The AMA RUC
reviewed the survey results, compared
the code to other services, and
recommended the survey 25th
percentile work RVU of 14.99. We
determined that the work associated
with CPT code 32098 was similar in
terms of physician time and intensity to
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CPT code 47100 (Biopsy of liver,
wedge). We believe crosswalking to the
work RVU of CPT code 47100
appropriately accounts for the work
associated with CPT code 32098.
Therefore, we are assigning a work RVU
of 12.91 to CPT code 32098 on an
interim final basis for CY 2012.
After clinical review of CPT code
32100 (Thoracotomy; with exploration),
we believe a work RVU of 13.75
accurately reflects the work associated
with this service compared to other
related services. The AMA RUC
reviewed the survey results, compared
the code to other services, and
recommended a work RVU of 17.00. The
AMA RUC concluded that CPT code
32100 is similar to new CPT code
32096, for which the AMA RUC
recommended a work RVU of 17.00. We
recognize the specialty society and
AMA RUC assertion that CPT code
32100 should be valued the same as
CPT codes 32096 and 32097 based on
the assessment that the work is similar
between these three services. We note
that we assigned a work RVU of 13.75
to CPT codes 32096 and 32097.
Accordingly, we are assigning a work
RVU of 13.75 for CPT code 32100 on an
interim final basis for CY 2012.
After clinical review of CPT code
32505 (Thoracotomy; with therapeutic
wedge resection (e.g., mass, nodule),
initial), we believe a work RVU of 15.75
accurately reflects the work associated
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with this service compared to other
related services. The AMA RUC
reviewed the survey results, compared
the code to other services, and
recommended the survey 25th
percentile work RVU of 18.79. We
recognize that CPT code 32505 has
greater physician work and intensity
compared to CPT code 32096, and we
believe the additional 30 minutes of
intra-service work associated with CPT
code 32505 accounts for the additional
work RVUs assigned to this service as
compared to CPT code 32096, and that
this incremental difference is equivalent
to 2.00 work RVUs. Accordingly, we are
assigning a work RVU of 15.75 for CPT
code 32505 on an interim final basis for
CY 2012.
After clinical review of CPT code
32507 (Thoracotomy; with diagnostic
wedge resection followed by anatomic
lung resection (List separately in
addition to code for primary
procedure)), we believe a work RVU of
3.00 accurately reflects the work
associated with this service compared to
other related services. The AMA RUC
reviewed the survey results, compared
the code to other services, and
recommended the survey 25th
percentile work RVU of 3.78. We believe
that the work associated with this
service is similar to the work of CPT
code 32506 and should be valued the
same. Accordingly, we are assigning a
work RVU of 3.00 to CPT code 32507 on
an interim final basis for CY 2012.
For CPT code 32663 (Thoracoscopy,
surgical; with lobectomy (single lobe)),
the AMA RUC recommended a work
RVU of 24.64. Upon clinical review, we
have determined that it is most
appropriate to accept the AMA RUC
recommended work RVU of 24.64 on a
provisional basis, pending review of the
open heart surgery analogs, in this case,
CPT code 32480. We are requesting the
AMA RUC look at the incremental
difference in RVUs and times between
the open and laparoscopic surgeries and
recommend a consistent valuation of
RVUs and time for CPT code 32663 and
other services within this family with
this same issue. Accordingly, we are
assigning a work RVU of 24.64 for CPT
code 32663 on an interim basis for CY
2012.
After clinical review of CPT code
32668 (Thoracoscopy, surgical; with
diagnostic wedge resection followed by
anatomic lung resection (List separately
in addition to code for primary
procedure)), we believe a work RVU of
3.00 accurately reflects the work
associated with this service compared to
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other related services. The AMA RUC
reviewed the survey results, compared
the code to other services, and
recommended the survey 25th
percentile work RVU of 4.00. We believe
that the work associated with this
service is similar to the work of CPT
code 32506, which we have valued at a
work RVU of 3.00. Accordingly, we are
assigning a work RVU of 3.00 to CPT
code 32668 on an interim basis for CY
2012.
For CPT code 32669 (Thoracoscopy,
surgical; with removal of a single lung
segment (segmentectomy)), the AMA
RUC recommended a work RVU of
23.53. Upon clinical review, we have
determined that it is most appropriate to
accept the AMA RUC recommended
work RVU of 23.53 on a provisional
basis, pending review of the open heart
surgery analogs, in this case CPT code
32480. We are requesting the AMA RUC
look at the incremental difference in
RVUs and times between the open and
laparoscopic surgeries and recommend
a consistent valuation for CPT 32669
and other services within this family
with this same issue. Accordingly, we
are assigning a work RVU of 23.53 to
CPT code 32669 on an interim basis for
CY 2012.
For CPT code 32670 (Thoracoscopy,
surgical; with removal of two lobes
(bilobectomy)) the AMA RUC
recommended a work RVU of 28.52.
Upon clinical review, we have
determined that it is most appropriate to
accept the AMA RUC recommended
work RVU of 28.52 on a provisional
basis, pending review of the open heart
surgery analogs, in this case CPT code
32482. We are requesting the AMA RUC
look at the incremental difference in
RVUs and times between the open and
laparoscopic surgeries and recommend
a consistent valuation for CPT 32670
and other services within this family
with this same issue. Accordingly, we
are assigning a work RVU of 28.52 to
CPT code 32670 on an interim basis for
CY 2012.
For CPT code 32671 (Thoracoscopy,
surgical; with removal of lung
(pneumonectomy)), the AMA RUC
recommended a work RVU of 31.92.
Upon clinical review, we have
determined that it is most appropriate to
accept the AMA RUC recommended
work RVU of 31.92 on a provisional
basis, pending review of the open heart
surgery analogs, in this case CPT code
32440. We are requesting the AMA RUC
look at the incremental difference in
RVUs and times between the open and
laparoscopic surgeries and recommend
PO 00000
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73195
a consistent valuation for CPT 32671
and other services within this family
with this same issue. Accordingly, we
are assigning a work RVU of 31.92 to
CPT code 32671 on an interim basis for
CY 2012.
For CPT code 32672 (Thoracoscopy,
surgical; with resection-plication for
emphysematous lung (bullous or nonbullous) for lung volume reduction
(LVRS), unilateral includes any pleural
procedure, when performed), the AMA
RUC recommended a work RVU of
27.00. Upon clinical review, we have
determined that it is most appropriate to
accept the AMA RUC recommended
work RVU of 27.00 on a provisional
basis, pending review of the open heart
surgery analogs, in this case CPT code
32491. We are requesting the AMA RUC
look at the incremental difference in
RVUs and times between the open and
laparoscopic surgeries and recommend
a consistent valuation for CPT 32672
and other services within this family
with this same issue. Accordingly, we
are assigning a work RVU of 27.00 to
CPT code 32672 on an interim basis for
CY 2012.
For CPT code 32673 (Thoracoscopy,
surgical; with resection of thymus,
unilateral or bilateral), the AMA RUC
recommended a work RVU of 21.13.
Upon clinical review, we have
determined that it is most appropriate to
accept the AMA RUC recommended
work RVU of 21.13 on a provisional
basis, pending review of related CPT
codes 60520 (Thymectomy, partial or
total; transcervical approach (separate
procedure)), 60521 (Thymectomy,
partial or total; sternal split or
transthoracic approach, without radical
mediastinal dissection (separate
procedure)), and 60522 (Thymectomy,
partial or total; sternal split or
transthoracic approach, with radical
mediastinal dissection (separate
procedure)). At this time, we have
concerns about appropriate relativity
between the times and RVUs of these
services. We are assigning a work RVU
of 21.13 to CPT code 32673 on an
interim basis for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
(8) Cardiovascular: Heart and
Pericardium
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(A) Pediatric Cardiovascular Code (CPT
Code 36000)
The AMA RUC recommended that
CMS consider a bundled status for CPT
code 36000, (Introduction of needle or
intracatheter, vein) because the AMA
RUC and many specialty societies
believe CPT code 36000 always is a
component of other services. We agree
with the AMA RUC recommendation
and for CY 2012, CPT code 36000 will
have a status code of B (bundled). We
are publishing the RVUs for CPT code
36000 in the CY 2012 PFS, but Medicare
will no longer make separate payment
for this service.
emcdonald on DSK4SPTVN1PROD with RULES2
(B) Renal Angiography Codes (CPT
Codes 36251–36254)
CPT codes 75722 and 75724 were
identified through the Codes Reported
Together 75 percent or More screen.
These supervision and interpretation
codes were commonly billed with the
catheter placement code 36245. For CY
2012, the specialties submitted a code
change proposal to the CPT Editorial
Panel to bundle the services commonly
reported together. The panel deleted
CPT codes 75722 and 75724 and created
4 bundled services (CPT codes 36251,
36252, 36253, and 36254) for CY 2012.
After clinical review of CPT code
36251 (Selective catheter placement
(first-order), main renal artery and any
accessory renal artery(s) for renal
angiography, including arterial puncture
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and catheter placement(s), fluoroscopy,
contrast injection(s), image
postprocessing, permanent recording of
images, and radiologic supervision and
interpretation, including pressure
gradient measurements when
performed, and flush aortogram when
performed; unilateral), we believe a
work RVU of 5.35 accurately reflects the
work associated with this service. The
AMA RUC reviewed the survey results,
compared the code to other services,
and concluded that the work value for
CPT code 36251 should be directly
crosswalked to CPT code 31267 (Nasal/
sinus endoscopy, surgical, with
maxillary antrostomy; with removal of
tissue from maxillary sinus) (work RVU
= 5.45). The AMA RUC recommended a
work RVU of 5.45 for CPT code 36251.
We determined that the work associated
with CPT code 36251 is closely aligned
in terms of physician time and intensity
with CPT code 52341
(Cystourethroscopy; with treatment of
ureteral stricture (e.g., balloon dilation,
laser, electrocautery, and incision)
(work RVU=5.35). We believe
crosswalking to the work RVU of CPT
code 52341 appropriately accounts for
the work associated with CPT code
36251. Therefore, we are assigning a
work RVU of 5.35 to CPT code 36251 on
an interim final basis for CY 2012.
After clinical review of CPT code
36252 (Selective catheter placement
(first-order), main renal artery and any
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accessory renal artery(s) for renal
angiography, including arterial puncture
and catheter placement(s), fluoroscopy,
contrast injection(s), image
postprocessing, permanent recording of
images, and radiologic supervision and
interpretation, including pressure
gradient measurements when
performed, and flush aortogram when
performed; bilateral), we believe a work
RVU of 6.99 accurately reflects the work
associated with this service. The AMA
RUC reviewed the survey results,
compared the code to other services,
and concluded that the work value for
CPT code 36252 should be directly
crosswalked to CPT code 43272
(Endoscopic retrograde
cholangiopancreatography (ERCP); with
ablation of tumor(s), polyp(s), or other
lesion(s) not amenable to removal by hot
biopsy forceps, bipolar cautery or snare
technique) (work RVU = 7.38). While
the AMA RUC recommended a work
RVU of 7.38 for CPT code 36252. We
believe the intensity of this service is
akin to CPT code 58560 (Hysteroscopy,
surgical; with division or resection of
intrauterine septum (any method))
(work RVU = 6.99). Accordingly, we are
assigning a work RVU of 6.99 to CPT
code 36252 on an interim final basis for
CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
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73197
(C) IVC Transcatheter Procedures (CPT
Codes 37191–37193)
After clinical review of CPT code
37192 (Repositioning of intravascular
vena cava filter, endovascular approach
inclusive of vascular access, vessel
selection, and all radiological
supervision and interpretation,
intraprocedural roadmapping, and
imaging guidance (ultrasound and
fluoroscopy)), we believe a work RVU of
7.35 accurately reflects the work
associated with this service. The AMA
RUC reviewed the survey results,
compared the code to other services,
and concluded that the survey 75th
percentile intra-service time of 60
minutes and the 25th percentile of work
RVU of 8.00 accurately describes the
physician work involved in the service.
We determined that the work associated
with CPT code 37192 is similar to CPT
code 93460 (Catheter placement in
coronary artery(s) for coronary
angiography, including intraprocedural
injection(s) for coronary angiography,
imaging supervision and interpretation;
with right and left heart catheterization
including intraprocedural injection(s)
for left ventriculography, when
performed), which has a work RVU of
7.35 and has the following times: 48
minutes pre-service, 50 minutes intraservice, and 30 minutes post-service. As
such, we believe that the survey median
intra-service time of 45 minutes
appropriately accounts for the time
required to furnish the intra-service
work of this procedure. Therefore, we
are assigning a work RVU of 7.35 to CPT
code 37192, with a refinement to 45
minutes of intra-service time, on an
interim final basis for CY 2012. A
complete listing of the times associated
with this code is available on the CMS
Web site at: https://www.cms.gov/
PhysicianFeeSched/.
After clinical review of CPT code
37193 (Retrieval (removal) of
intravascular vena cava filter,
endovascular approach inclusive of
vascular access, vessel selection, and all
radiological supervision and
interpretation, intraprocedural
roadmapping, and imaging guidance
(ultrasound and fluoroscopy)), we
believe a work RVU of 7.35 accurately
reflects the work associated with this
service. The AMA RUC reviewed the
survey results, compared the code to
other services, and concluded that the
survey 75th percentile intra-service time
of 60 minutes and the 25th percentile of
work RVU of 8.00 accurately describes
the physician work involved in the
service. We believe that the work
associated with CPT code 37193 is
similiar to CPT code 93460 (Catheter
placement in coronary artery(s) for
coronary angiography, including
intraprocedural injection(s) for coronary
angiography, imaging supervision and
interpretation; with right and left heart
catheterization including
intraprocedural injection(s) for left
ventriculography, when performed),
which has a work RVU of 7.35 and the
following times: 48 minutes pre-service,
50 minutes intra-service, and 30
minutes post-service. As such, we
believe that the survey median intraservice time of 45 minutes appropriately
accounts for the time required to furnish
the intra-service work associated with
this procedure. Therefore, we are
assigning a work RVU of 7.35 to CPT
code 37193, with a refinement to 45
minutes of intra-service time, on an
interim final basis for CY 2012. A
complete listing of the times associated
with this code is available on the CMS
Web site at: https://www.cms.gov/
PhysicianFeeSched/.
After clinical review of CPT code
37619 (Ligation of inferior vena cava),
we believe a work RVU of 30.00
accurately reflects the work associated
with this service. The AMA RUC
reviewed the survey results, compared
the code to other services, and
concluded that the survey respondents
underestimated the total physician work
for this rarely performed service, by
underestimating the significant postoperative work. The AMA RUC
recommended a work RVU of 37.60 for
CPT code 37619. We determined that
the work associated with this service is
more aligned with reference CPT code
37617 (Ligation, major artery (e.g., posttraumatic, rupture); abdomen) (work
RVU = 23.97), therefore we believe the
survey median work RVU of 30.00 is
more appropriate. Accordingly, we are
assigning a work RVU of 30.00 to CPT
code 37619 on an interim final basis for
CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
For CY 2012, the CPT Editorial Panel
split CPT code 38230 into two separate
codes: 38230 (Bone marrow harvesting
for transplantation; allogeneic), and
38232 (Bone marrow harvesting for
transplantation; autologous) to more
accurately reflect current practice. For
CY 2012, we changed the global period
from 010 to 000 for CPT code 38230,
and also assigned a global period of 000
to CPT code 38232, as these services
rarely require overnight hospitalization
and physician follow-up in the days
following the procedure.
After clinical review of CPT codes
38230 and 38232, we believe that a
work RVU of 3.09 appropriately
accounts for the work associated with
these services. The AMA RUC reviewed
the specialty society survey results and,
after comparison to similar CPT codes,
the AMA RUC recommended the survey
median work RVU of 4.00 for CPT code
38230, and the survey median work
RVU of 3.50 for CPT code 38232. We
believe that the work for these services
is very similar and should be valued the
same. CPT code 38230 currently (CY
2011) has a work RVU of 4.85 with a
ten-day global period that includes 1
CPT code 99213 level 3 office or
outpatient visit, and 1 CPT code 99238
discharge day management service. To
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(9) Hemic and Lymphatic Systems:
General, Bone Marrow or Stem Cell
Services/Procedures (CPT Codes 38230
and 38232)
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emcdonald on DSK4SPTVN1PROD with RULES2
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
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However, we believe that a work RVU
of 2.60 would place these services too
low compared to similar services. We
believe that the CPT code 32830 survey
25th percentile work RVU of 3.09
accurately captures the intensity of
these two services. Therefore, we are
assigning a work RVU of 3.09 to CPT
codes 32830 and 32832 on an interim
final basis for CY 2012.
We identified CPT code 47000
(Biopsy of liver, needle; percutaneous)
as potentially misvalued through the
Harvard-Valued—Utilization > 30,000
screen.
After clinical review of CPT code
47000, we believe that the current (CY
2011) work RVU of 1.90 be maintained.
The AMA RUC reviewed the specialty
society survey data, and also concluded
that a work RVU of 1.90 be maintained.
We request that the AMA RUC and CPT
Editorial Panel consider reviewing all
the percutaneous biopsy CPT codes to
incorporate imaging guidance into the
RVU and descriptor where appropriate.
We are assigning a work RVU of 1.90 to
CPT code 47000 on an interim final
basis for CY 2012.
The AMA RUC identified CPT codes
49080 and 49081 through the HarvardValued—Utilization > 100,000 screen.
The related specialty societies noted
that the services have evolved since the
codes were initially established and
need separate codes that distinguish
paracentesis performed without imaging
guidance and paracentesis performed
with imaging guidance. For CY 2012,
the CPT Editorial Panel deleted CPT
codes 49080 and 49081 and created 3
new CPT codes, 49082, 49083, and
49084, to more accurately describe the
current medical practice.
After clinical review of CPT code
49082 (Abdominal paracentesis
(diagnostic or therapeutic); without
imaging guidance), we believe that a
work RVU of 1.24 accurately accounts
for the work associated with this
service. The AMA RUC recommended a
work RVU of 1.35 for CPT code 49082,
which corresponds to the current (CY
2011) work RVU for CPT code 49080
(CY 2011 descriptor: Peritoneocentesis,
abdominal paracentesis, or peritoneal
lavage (diagnostic or therapeutic);
initial). For CPT code 49082 we believe
that the survey response rate (9 of 517)
is too low to produce a reliable estimate.
We believe that CPT code 49082 is
similar in time and intensity to CPT
code 32562 (Instillation(s), via chest
tube/catheter, agent for fibrinolysis (e.g.,
fibrinolytic agent for break up of
multiloculated effusion); subsequent
day) which has a work RVU of 1.24 and
10 minutes of intra-service time.
Therefore, we are assigning a work RVU
of 1.24, with a refinement to 10 minutes
of intra-service time, to CPT code 49082
for CY 2012. A complete listing of the
times associated with this CPT code is
available on the CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/.
After clinical review of CPT codes
49083 (Abdominal paracentesis
(diagnostic or therapeutic); with
imaging guidance) and 49084
(Peritoneal lavage, including imaging
guidance, when performed), we believe
that a work RVU of 2.00 accurately
accounts for the work associated with
these services. After comparison to
similar CPT codes, the AMA RUC
recommended a work RVU of 2.00 for
CPT code 49083 and a work RVU of 2.50
for CPT code 49084. We agree with the
AMA RUC-recommended work RVU of
2.00 for CPT code 49083, and believe
that CPT code 49084 requires similar
work and should be valued the same.
Therefore, we are assigning a work RVU
of 2.00 to CPT codes 49083 and 49084
on an interim final basis for CY 2012.
(10) Digestive: Liver (CPT Code 47000)
(11) Digestive: Abdomen, Peritoneum,
and Omentum (CPT Codes 49082–
49084)
ER28NO11.058</GPH>
(12) Nervous: Spine and Spinal Cord
(CPT Codes 62367–62370)
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emcdonald on DSK4SPTVN1PROD with RULES2
convert CPT code 38230 from a 10-day
global period to a 0-day global period,
one could subtract out the work RVUs
for CPT code 99213 (work RVU = 0.97)
and CPT code 99238 (work RVU = 1.28),
resulting in a work RVU of 2.60.
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73199
After clinical review of CPT code
62370 (Electronic analysis of
programmable, implanted pump for
intrathecal or epidural drug infusion
(includes evaluation of reservoir status,
alarm status, drug prescription status);
with reprogramming and refill
(requiring physician’s skill)), we believe
that a work RVU of 0.90 accurately
accounts for the work associated with
this service. After a comparison to
similar services, the AMA RUC
recommended a work RVU of 1.10 for
CPT code 62370 based on a crosswalk
to CPT code 56605 (Biopsy of vulva or
perineum (separate procedure); 1
lesion). We believe that a work RVU of
1.10 for CPT code 62370 is too high
compared to similar services in this
family. We find CPT code 62370 to be
similar in intensity and complexity to
CPT code 93281 (Programming device
evaluation (in person) with iterative
adjustment of the implantable device to
test the function of the device and select
optimal permanent programmed values
with physician analysis, review and
report; multiple lead pacemaker system)
(work RVU = 0.90). We believe that a
work RVU of 0.90, which is between the
specialty society survey 25th percentile
and median work RVU, appropriately
reflects the work of CPT code 62370.
Therefore, we are assigning a work RVU
of 0.90 to CPT code 62370 on an interim
final basis for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
CPT code 64626 was identified by the
AMA RUC’s Five-Year Review
Identification Workgroup as potentially
misvalued through the Site-of-Service
Anomaly screen. The specialty society
requested and the AMA RUC agreed that
CPT codes 64622, 64623, 64626, 64627
be referred to CPT to clarify that
imaging is required. For CY 2012, the
CPT Editorial Panel deleted four CPT
codes (64622–64623, and 64626–64627)
and created four new CPT codes
(64633–64636) to describe neurolysis
reported per joint (2 nerves per each
joint) instead of per nerve, under image
guidance.
After clinical review of CPT codes
64633 (Destruction by neurolytic agent,
paravertebral facet joint nerve(s);
cervical or thoracic, with image
guidance (fluoroscopy or CT), single
facet joint), 64634 (Destruction by
neurolytic agent, paravertebral facet
joint nerve(s); cervical or thoracic, with
image guidance (fluoroscopy or CT),
each additional facet joint (List
separately in addition to code for
primary procedure)), 64635 (Destruction
by neurolytic agent, paravertebral facet
joint nerve(s); lumbar or sacral, with
image guidance (fluoroscopy or CT),
single facet joint), and 64636
(Destruction by neurolytic agent,
paravertebral facet joint nerve(s); lumbar
or sacral, with image guidance
(fluoroscopy or CT), each additional
facet joint (List separately in addition to
code for primary procedure)), we
believe that the specialty society survey
25th percentile work RVUs of 3.84, 1.32,
3.78, and 1.16 (respectively) accurately
reflect the work associated with these
services. These are also the AMA RUCrecommended work RVUs for these
services. For CPT codes 64635 and
64636, we believe that the survey
median intra-service times of 28
minutes and 15 minutes (respectively)
appropriately allow for the intra-service
work associated with furnishing these
services. The AMA RUC recommended
an intra-service time of 30 minutes for
CPT code 64635, and an intra-service
time of 20 minutes for CPT code 64636.
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(13) Nervous: Extracranial Nerves,
Peripheral Nerves, and Autonomic
Nervous System (CPT Codes 64633–
64636)
ER28NO11.059</GPH>
emcdonald on DSK4SPTVN1PROD with RULES2
For CY 2012 the AMA RUC Relativity
Assessment Workgroup identified CPT
codes 62367, 62368, 95990, and 95991
as part of the Codes Reported Together
75 percent or More screen. For CY 2012,
the CPT Editorial Panel created 2 new
CPT codes, 62369 and 62370, to report
electronic analysis of programmable
implanted pump for intrathecal or
epidural drug infusion with
reprogramming and refill requiring and
not requiring physician’s skill and
editorially revised 3 existing CPT codes,
CPT code 62367 to report without
reprogramming or refill and CPT codes
95990 and 95991 to report refilling and
maintenance of implantable pump or
reservoir for drug delivery requiring and
not requiring physician skill. The
changes to CPT code 95990 and 95991
were editorial only and did not require
a review of the physician work or
practice expense.
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and a work RVU of 1.16 for CPT code
64636, with refinement to the AMA
RUC-recommended time. A complete
listing of the times associated with these
procedures is available on the CMS Web
site at: https://www.cms.gov/
PhysicianFeeSched/. Additionally, we
request that the AMA RUC review CPT
code 64681 (Destruction by neurolytic
agent, with or without radiologic
monitoring; superior hypogastric
plexus) which was the reference service
for CPT codes 64633 and 64635.
CPT codes 74175 and 72191 were
identified by the AMA RUC Relativity
Assessment Workgroup’s Codes
Reported Together 75 percent or More
screen, with both services reported over
95 percent of the time together. For CY
2012, the CPT Editorial Panel created
CPT code 74174 which bundles the
work of CPT codes 74175 and 72191
when reported together on the same
date of service.
We reviewed CPT code 74174
(Computed tomographic angiography,
abdomen and pelvis; with contrast
material(s), including noncontrast
images, if performed, and image
postprocessing), and are accepting the
AMA RUC-recommended work RVUs
and times on an interim basis for CY
2012. We request that the AMA RUC
review the component CPT codes:
74175 (Computed tomographic
angiography, abdomen, with contrast
material(s), including noncontrast
images, if performed, and image
postprocessing) and 72191 (Computed
tomographic angiography, pelvis, with
contrast material(s), including
noncontrast images, if performed, and
image postprocessing). On an interim
basis for CY 2012 we are assigning a
work RVU of 2.20 to CPT code 74174.
CPT code 88104 was identified
through the AMA RUC Relativity
Assessment Workgroup by the HarvardValued—Utilization > 100,000.
Additionally, CPT codes 88106–88108
were identified as part of the
Cytopathology family for AMA RUC
review.
After clinical review of CPT code
88104 (Cytopathology, fluids, washings
or brushings, except cervical or vaginal;
smears with interpretation), we believe
that the current (CY 2011) work RVU of
0.56 accurately reflects the work
associated with this service. We also
believe that 24 minutes of intra-service
time, the survey median, and no pre- or
post-service time is appropriate for this
service. That AMA RUC also
recommended a work RVU of 0.56 for
CPT code 88104 and 24 minutes of
intra-service time with no pre- or postservice time. Therefore, we are
maintaining the current work RVU of
0.56 and 24 minutes of intra service
time for CPT code 88104 on an interim
final basis for CY 2012.
After clinical review of CPT code
88106 (Cytopathology, fluids, washings
or brushings, except cervical or vaginal;
simple filter method with
interpretation) we believe that a work
RVU of 0.37 accurately reflects the work
associated with this service. The AMA
RUC reviewed the survey results for
CPT code 88106 and recommended a
work RVU of 0.56. However, we believe
that this value overstates the work of
this service when compared to the CPT
code 88104. We believe that CPT code
88106 is similar in intensity to CPT
code 88104, and that the primary factor
distinguishing the work of the two
services is the intra-service time. As
previously, CPT code 88104 has a work
RVU of 0.56, and 24 minutes of intraservice time. For CPT code 88106, we
believe 16 minutes of intra-service time,
the survey median, is appropriate for
this service. Therefore, we believe that
the work RVU for CPT code 88106
should be reduced proportionately to
reflect the lower intra-service time in
order to maintain relativity with the
CPT code 88104.
In calculating the RVU for CPT code
88106, we determined the RVU per
minute (0.56/24 = 0.023) for the CPT
code 88104. Then we multiplied the
RVU per minute (0.023) of CPT code
88104 by the intra-service minutes for
CPT code 88106 (0.023*16 = 0.37). We
believe a work RVU of 0.37
appropriately maintains relativity with
CPT code 88104. Therefore, we are
assigning a work RVU of 0.37 for CPT
code 88106 and an intra-service time of
16 minutes on an interim final basis for
CY 2012. The times assigned to this CPT
code are available on the CMS Web site
at: https://www.cms.gov/
PhysicianFeeSched/.
After clinical review of CPT code
88108 (Cytopathology, concentration
technique, smears and interpretation
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(14) Diagnostic Radiology: Abdomen
(CPT Code 74174)
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(15) Pathology and Laboratory:
Cytopathology (CPT Codes 88104,
88106, and 88108)
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In sum, on an interim final basis for CY
2012 we are finalizing a work RVU of
3.84 for CPT code 64633 and a work
RVU of 1.32 for CPT code 64634,
without refinement to the AMA RUCrecommended time. On an interim final
basis for CY 2012 we are finalizing a
work RVU of 3.78 for CPT code 64635
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
73201
24 minutes of intra-service time. For
CPT code 88108, we believe 19 minutes
of intra-service time, the survey median,
is appropriate for this service.
Therefore, we believe that the work
RVU for CPT code 88108 should be
reduced proportionately to reflect the
lower intra-service time in order to
maintain relativity with CPT code
88104.
In calculating the RVU for CPT code
88108, we determined the RVU per
minute (0.56/24 = 0.023) for the CPT
code 88104. Then we multiplied the
RVU per minute (0.023) of CPT code
88104 by the intra-service minutes for
CPT code 88108 (0.023*19 = 0.44). We
believe a work RVU of 0.44
appropriately maintains relativity with
CPT code 88104. Therefore we are
assigning a work RVU of 0.44 and an
intra-service time of 19 minutes to CPT
code 88108 on an interim final basis for
CY 2012. The times assigned to this CPT
code are available on the CMS Web site
at: https://www.cms.gov/
PhysicianFeeSched/.
CPT code 90845 was first considered as
part of the Fourth Five-Year Review.
However, in that review process, the
related specialty societies referred the
family of services to the CPT Editorial
Panel to consider a revision to the code
descriptors. During the CPT review
process, CPT recommended removing
CPT code 90845 from the list of codes
for revision, as CPT believed revisions
to the descriptor were unnecessary
because the work inherent in providing
this service was the same regardless of
provider.
After clinical review of CPT code
90845 (Psychoanalysis), including a
review of the information provided by
the specialty societies and the AMA
RUC, we believe that the current (2011)
work RVU of 1.79 and the current times
should be maintained for this code until
the other codes in the family are revised
by CPT and reviewed by the AMA RUC.
The AMA RUC recommended a work
RVU of 2.10 for CPT code 90845. We
would like to refrain from establishing
a new interim final value for CPT code
90845 until we can view this CPT code
relative to the revised codes in the
family, which we anticipate reviewing
for CY 2013. Therefore, we are
maintaining the current work RVU of
1.79 and current times for CPT code
90845 on an interim basis for CY 2012.
A complete listing of the times
associated with CPT code 90845 is
available on the CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/.
For CY 2011 the CPT Editorial Panel
converted Category III codes 0160T and
0161T to Category I status CPT codes
90867 and 90868, which were
contractor priced on the Physician Fee
Schedule. For CY 2012, the CPT
Editorial Panel modified CPT codes
90867 and 90868, and created CPT code
90869. These three CPT codes are priced
on the Physician Fee Schedule for CY
2012.
After clinical review of CPT code
90867 (Therapeutic repetitive
transcranial magnetic stimulation (TMS)
treatment; initial, including cortical
mapping, motor threshold
determination, delivery and
management), we believe that the AMA
RUC-recommended survey median work
RVU of 3.52 appropriately reflects the
work associated with this service.
However, we believe that the survey
75th percentile intra-service time of 60
minutes appropriately accounts for the
time required to furnish the intraservice work of this procedure. The
AMA RUC recommended 65 minutes of
intra-service time for CPT code 90867.
We are assigning a work RVU of 3.52,
with refinement to 60 minutes of intraservice time, to CPT code 90867 on an
interim final basis for CY 2012. A
complete listing of the times associated
with CPT code 90867 is available on the
CMS Web site at:
https://www.cms.gov/
PhysicianFeeSched/.
After clinical review of CPT code
90869 (Therapeutic repetitive
transcranial magnetic stimulation (TMS)
treatment; subsequent motor threshold
re-determination with delivery and
management), we believe that a work
RVU of 3.00 appropriately accounts for
the work associated with this service.
The original specialty society
recommendation to the AMA RUC for
CPT code 90869 was for a work RVU of
3.00, and the AMA RUC recommended
to us a work RVU of 3.20, the survey
median. We believe that CPT code
90869 is similar in time and intensity to
CPT code 95974 (Electronic analysis of
implanted neurostimulator pulse
generator system (e.g., rate, pulse
amplitude and duration, configuration
of wave form, battery status, electrode
selectability, output modulation,
cycling, impedance and patient
compliance measurements); complex
cranial nerve neurostimulator pulse
generator/transmitter, with
intraoperative or subsequent
programming, with or without nerve
interface testing, first hour) (work RVU
= 3.00), and the work should be valued
the same. Therefore, we are assigning a
work RVU of 3.00 to CPT code 90869 on
an interim final basis for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
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(16) Psychiatry: Psychiatric Therapeutic
Procedures (CPT Code 90845, 90867–
90869)
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(e.g., Saccomanno technique)), we
believe that a work RVU of 0.44
accurately reflects the work associated
with this service. The AMA RUC
reviewed the survey results for CPT
code 88106 and recommended a work
RVU of 0.56. However, we believe that
this value overstates the work of this
service when compared to CPT code
88104. We believe that CPT code 88108
is similar in intensity to CPT code
88104, and that the primary factor
distinguishing the work of the two
services is the intra-service time. CPT
code 88104 has a work RVU of 0.56, and
73202
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setting as interim final the work RVUs
listed in Table 19.
(17) Ophthalmology: Special
Ophthalmological Services (92071 and
92072)
For the Fourth Five-Year Review, we
identified CPT code 92070 through the
Harvard-Valued—Utilization > 30,000
screen. Upon review of this service, the
specialty societies agreed that there are
two distinct uses for CPT code 92070
that have substantially different levels
of work. For CY 2012, the CPT Editorial
Panel agreed and deleted CPT code
92070 and created two new CPT codes
(92071 and 92072) to distinguish
reporting of fitting of contact lens for
treatment of ocular surface disease and
fitting of contact lens for management of
keratoconus.
CPT code 92070 (Fitting of contact
lens for treatment of disease, including
supply of lens) is being deleted for CY
2012 and the utilization from CPT code
92070 is expected to be captured by new
CPT code 92071(Fitting of contact lens
for treatment of ocular surface disease).
As CPT code 92070 was typically billed
with an E/M service on the same day,
we believe that CPT code 92071 will
also be billed typically with an E/m
service on the same day. We believe
some of the activities conducted during
the pre- and post-service times of the
procedure code and the E/M visit
overlap and, therefore, should not be
counted twice in developing the
procedure’s work value. As described
earlier in section III.A. of this final rule
with comment period, to account for
this overlap, we reduced the pre-service
evaluation and post-service time by onethird. For CPT code 92071 we reduced
the pre-service evaluation time and the
post service time from 5 minutes to 3
minutes.
In order to determine the appropriate
work RVU for CPT code 92071, given
the time change, we calculated the value
of the extracted time and subtracted it
from the AMA RUC-recommended work
RVU. For CPT code 92071, we removed
a total of 4 minutes at an intensity of
0.0224 per minute, which amounts to
the removal of 0.09 of a work RVU. The
AMA RUC recommended a work RVU
of 0.70, the current (CY 2011) work RVU
for CPT code 92070. Therefore, we are
assigning an interim final work RVU of
0.61, with refinement to time, to CPT
code 92071 for CY 2012. A complete
listing of the times assigned to CPT code
92071 is available on the CMS Web site
at: https://www.cms.gov/
PhysicianFeeSched/.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
We identified CPT code 92587
through the CMS Fastest Growing
screen. For CY 2011, the specialty
society surveyed this service, however,
after reviewing the survey data, they
concluded that more than one service is
being represented under this code and
requested the service be referred back to
the CPT Editorial Panel for further
clarification. For CY 2012, the CPT
Editorial Panel created CPT code 92558
to describe evoked otoacoustic
emissions screening and revised CPT
codes 92587 and 92588 clarify the
otoaucoustic emissions evaluations.
New CPT code 92558 (Evoked
otoacoustic emissions; screening
(qualitative measurement of distortion
product or transient evoked otoacoustic
emissions), automated analysis)
describes a screening service that does
not fall within the statutory definition of
a physicians’ service, per section 1848
of the Act. As such, CPT code 92558
will have procedure status of X on the
PFS for CY 2012, which indicates that
this service is not within the statutory
definition of ‘‘physicians’ service’’ for
PFS payment purposes. We will not pay
for CPT code 92558 under the PFS. We
note that the HCPAC recommended a
work RVU of 0.17, with 5 minutes of
intra-service time and 2 minutes of
immediate post-service time, for CPT
code 92558.
After clinical review of CPT code
92587 (Distortion product evoked
otoacoustic emissions; limited
evaluation (to confirm the presence or
absence of hearing disorder, 3–6
frequencies) or transient evoked
otoacoustic emissions, with
interpretation and report), we believe
that the survey 25th percentile work
RVU of 0.35 accurately describes the
work associated with this service. The
HCPAC reviewed the survey results, and
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(18) Special Otorhinolaryngologic
Services: Audiologic Function Tests
(CPT Codes 92558, 92587 and 92588)
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not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
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73203
After clinical review of CPT code
92588 (Distortion product evoked
otoacoustic emissions; comprehensive
diagnostic evaluation (quantitative
analysis of outer hair cell function by
cochlear mapping, minimum of 12
frequencies), with interpretation and
report), we believe that the survey 25th
percentile work RVU of 0.55 accurately
describes the work associated with this
service. The HCPAC reviewed the
survey results, and after a comparison to
similar CPT codes, recommended the
survey median work RVU of 0.62 for
CPT code 92588. We believe that CPT
code 92588 is similar in work to CPT
code 92570 (Acoustic immittance
testing, includes tympanometry
(impedance testing), acoustic reflex
threshold testing, and acoustic reflex
decay testing) (work RVU = 0.55), and
that the survey 25th percentile work
RVU of 0.55 appropriately reflects the
relativity of this service. Therefore, we
are assigning a work RVU of 0.55 to CPT
code 92588 on an interim final basis for
CY 2012.
As a result of the Medicare
Improvements for Patients and
Providers Act of 2008, starting in July
2009, speech-language pathologists were
able to bill Medicare independently as
private practitioners. The American
Speech-Language-Hearing Association
(ASHA) requested that we, in light of
the legislation, base speech-language
pathology services on professional work
values and not through the practice
expense component. As a result, we
requested that the AMA RUC review the
speech-language pathology codes for
professional work as requested by
ASHA. After reviewing the survey data
for CPT code 92605, the specialty
society indicated and the HCPAC agreed
that CPT code 92605 would be better
captured as a ‘‘per hour’’ code. For CY
2012, the CPT Editorial Panel revised
CPT code 92605 to indicate ‘‘first hour’’
and created a new add-on code (CPT
code 92618) to capture each additional
30 minutes.
Revised CPT code 92605 (CY 2012
long descriptor: Evaluation for
prescription of non-speech-generating
augmentative and alternative
communication device, face-to-face with
the patient; first hour) currently (CY
2011) has a procedure status indicator of
B on the PFS, which indicates that
payment for the service is always
bundled into payment for other services
not specified. We continue to believe
that payment for this service is included
in other services and, therefore, that
CPT code 92605 should maintain the
procedure status indicator of B on the
PFS. As new CPT code 92618
(Evaluation for prescription of nonspeech-generating augmentative and
alternative communication device, face-
to-face with the patient; each additional
30 minutes (List separately in addition
to code for primary procedure)) is the
add-on procedure code to CPT code
92605, we believe that payment for that
service should also be considered
bundled into payment for other services,
and therefore, should also have a
procedure status indicator of B on the
PFS. For CPT code 92605 the HCPAC
recommended the survey 25th
percentile work RVU of 1.75. For CPT
code 92618 the HCPAC recommended
the survey 25th percentile work RVU of
0.65. We are publishing these RVUs in
the CY 2012 PFS, however, as stated
previously, both codes will have a
procedure status indicator of B and will
not be separately payable on the PFS.
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(19) Special Otorhinolaryngologic
Services: Evaluative and Therapeutic
Services (CPT Codes 92605 and 92618)
(20) Cardiovascular: Cardiac
Catheterization (93451–93568)
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after a comparison to similar CPT codes,
recommended a work RVU of 0.45 for
CPT code 92587, which is between the
survey 25th percentile and median
values. We believe that CPT code 92587
is similar in time and intensity to CPT
code 97124 (Therapeutic procedure, 1 or
more areas, each 15 minutes; massage,
including effleurage, petrissage and/or
tapotement (stroking, compression,
percussion)) (work RVU = 0.35), and
that the survey 25th percentile value
appropriately reflects the relativity of
this service. Therefore, we are assigning
a work RVU of 0.35 to CPT code 92587
on an interim final basis for CY 2012.
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
In the CY 2012 final rule with
comment period (75 FR 73334 through
73337), we discussed generally the
concept of bundling services and
specifically, new CY 2011 CPT codes
that describe the bundling of two or
more existing component services
performed together 95 percent or more
of the time. As we noted in that rule, we
expect this bundling of component
services to continue over the next
several years as the work efficiencies for
services commonly furnished together
are recognized. Stakeholders should
expect that increased bundling of
services into fewer codes will result in
reduced PFS payment for a
comprehensive service. Specifically, the
decrease in RVUs assigned to the
comprehensive service, as compared to
the total RVUs of the sum of the
individual component services, reflects
the efficiencies in work and/or PE that
occur when component services are
furnished together.
For CY 2011, the AMA RUC provided
CMS with recommendations for several
categories of new comprehensive
services that historically have been
reported under multiple component
codes. These services fell into the three
major clinical categories of:
Endovascular revascularization,
computed tomography (CT), and
diagnostic cardiac catheterization. In the
CY 2011 final rule with comment
period, we acknowledged that while
each category of services is unique,
since bundling of component services is
likely to occur more often in the coming
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years, we believe a consistent approach
is especially important when valuing
bundled services to ensure that RVUs
reflect work efficiencies.
As discussed in the CY 2011 final rule
with comment period, the AMA RUC
used a variety of methodologies in
developing RVUs for comprehensive
codes in these three categories of
bundled services. To develop the RVUs
for the comprehensive endovascular
revascularization services, the AMA
RUC generally recommended the
median work RVUs from the physician
survey performed by the specialty
society. The recommended values for
the comprehensive services are an
average of 27 percent lower than the
summed RVUs of the component
services (taking into consideration any
MPPR that would currently apply)
included in the bundle. To develop the
RVUs for comprehensive CT services,
the AMA RUC recommended taking the
sum of 100 percent of the current work
RVUs for the code with the highest
RVUs and 50 percent for the second
code. Under this methodology, the
recommended work RVUs for the
comprehensive CT codes are
consistently approximately 25 percent
lower than the sum of the RVUs for the
component services (75 FR 7335
through 7336). We agreed in the CY
2011 final rule with comment period
that the decreased work RVUs that the
AMA RUC recommended for
comprehensive services in these two
categories reflected a reasonable
estimation of the work efficiencies
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created by the bundling of the
component services. Therefore, for CY
2011, we accepted as interim final work
RVUs the AMA RUC-recommended
values for endovascular
revascularization and CT services, and
we are finalizing our interim final work
RVUs without modification for CY 2012
(Table 15) see section III.B.1. of this
final rule with comment period.
In contrast to the endovascular
revascularization and CT codes, the
AMA RUC recommended values for the
comprehensive diagnostic cardiac
catheterization codes did not appear to
reflect the efficiencies in work and/or
PE that occur when component services
are furnished together. To develop the
RVUs for comprehensive diagnostic
cardiac catheterization services, the
AMA RUC generally recommended the
lower of either the sum of the current
RVUs for the component services or the
physician survey 25th percentile value.
In most cases, the AMA RUC’s
recommendation for the comprehensive
service was actually the sum of the
current work RVUs for the component
services, and we stated in the CY 2011
final rule with comment period that we
were unsure how this approach is
resource-based with respect to
physician work. We also were
concerned that the results of the
physician survey overstated the work
for these well-established procedures
because the 25th percentile work RVU
value was usually higher than the sum
of the current RVUs for the component
services. Finally, we noted that, in
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contrast to the RVU survey results,
survey physician times for the
comprehensive codes were significantly
reduced as compared to the summed
minutes of the component codes.
In contrast to the result of combining
the component codes into
comprehensive endovascular
revascularization and CT bundles where
efficiencies were reflected through
significant reductions in the RVUs
(average of 27 percent and 25 percent
respectively), the AMA RUCrecommended RVUs for the
comprehensive codes for diagnostic
cardiac catheterization were an average
of only one percent lower. We noted
that if we were to accept the AMA
RUC’s recommended values for these
cardiac catheterization codes, we
essentially would be agreeing with the
presumption that there are negligible
work efficiencies gained in the bundling
of these services. On the contrary, we
believed that the AMA RUC did not
fully consider or account for the
efficiency gains when the component
services are furnished together, which
was also supported by the significant
reduction in reported service time on
the survey. Therefore, in the CY 2011
final rule with comment period, we
requested that the AMA RUC reexamine
the cardiac catheterization codes as
quickly as possible, given the significant
PFS utilization and spending for these
services, and put forward an alternative
approach to valuing these services that
would produce relative values that are
resource-based and account for
efficiencies inherent in bundling.
For CY 2011, we also stated that we
believed the new comprehensive
diagnostic cardiac catheterization codes
would be overvalued under the AMA
RUC’s CY 2011 recommendations. To
address this potential overvaluation, we
employed an interim methodology to
approximate the efficiencies garnered
through the bundling of the component
codes to determine alternative CY 2011
interim values for the cardiac
catheterization codes based on the
information that we had at the time.
Given that the AMA RUC
recommendations for the bundling of
endovascular revascularization and CT
codes resulted in average reductions in
the RVUs of 27 percent and 25 percent
respectively, we believed an
approximation of work efficiencies
garnered through the bundling of the
component codes could be up to 27
percent. Since we were referring the
cardiac catheterization codes back to the
AMA RUC, requesting that the AMA
RUC provide CMS with a better estimate
of the work efficiencies, we believed at
the time that applying a conservative
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estimate of the work efficiencies was
appropriate as an interim measure.
Accordingly, to account for efficiencies
inherent in bundling, we set the work
RVUs for all of the bundled CY 2011
cardiac catheterization codes for which
we received AMA RUC
recommendations to 10 percent less
than the sum of the current work RVUs
for the component codes, taking into
consideration any MPPR that would
apply under current PFS policy.
At our request, the AMA RUC
reviewed these codes again for CY 2012
and reiterated its previous
recommendations, maintaining that
there are negligible work efficiencies
gained in the bundling of these services.
The AMA RUC noted that over the 20
years that cardiac catheterization
services have been available to patients,
several of the codes being bundled have
been bundled and unbundled a number
of times in the past and that in each
instance, the CMS has retained the
RVUs of component codes. In response
to CMS’ observation that the recently
surveyed physician times of the new CY
2011 comprehensive codes were
significantly reduced, the AMA RUC
stated that the new times were correct
and that the previous times were grossly
overstated. That is, the previous times
originating from the Harvard valuation
process rather than the survey process
were inaccurate. The AMA RUC
explained that the specialty societies
have not previously addressed
inaccurate physician times in any of the
previous bundling/unbundling
opportunities, because the societies
deemed physician time unimportant
and stakeholders focused on the work
RVUs of the services instead.
Stakeholders also strongly argued that
no one had previously validated the
physician time for the services in place
for 20 years, although they continued to
urge CMS to accept that the RVUs
developed through the same process
remain unchanged.
Comments: The commenters believed
that cardiac catheterization codes were
already under-valued, and therefore the
AMA RUC could not find any additional
efficiencies in its recommendation to
CMS regarding the bundling of these
codes. Commenters noted some of the
component catheterization codes were
reviewed by the AMA RUC in 2007 for
PE which has already resulted in
reduced payments for those services.
Commenters also asserted that
catheterization codes were developed
and intended to be used in conjunction
with one another and that each code
represents a distinct portion of the
catheterization procedure. The
commenters surmised that there is no
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73205
duplication in service time, equipment
or supplies. Finally, commenters
believed CMS did not base its 10percent reduction of cardiac
catheterization RVUs on any data
analysis.
Response: We disagree with the AMA
RUC’s recommendation that there are
negligible efficiencies in physician work
when the component services of
diagnostic cardiac catheterization are
performed together. Although the AMA
RUC did not revise their estimate of
physician work for these newly bundled
services, we find it difficult to accept
that there are no efficiencies in the 20
year evolution of cardiac catheterization
services. Improvements in technologies
associated with cardiac catheterization
and the increased familiarity with
performing these high frequency
services support some reduction in both
the physician times and the RVUs. We
do not believe that the AMA RUC
recommendations for CY 2012 fully
considered these areas for additional
efficiencies. Given the AMA RUC’s
valuation of newly bundled services for
endovascular revascularization and CT
codes, we were reasonably assured that
the approximation of work efficiencies
through bundling could be up to 27
percent. We ultimately used a very
conservative estimate of 10 percent for
the work efficiencies we would expect
to be present when multiple component
cardiac catheterization services are
bundled together into a single
comprehensive service for valuing these
services for CY 2011.
In lieu of a more specific estimate
from the AMA RUC, and using the best
information available to us at this time,
we believe it is appropriate to assign as
interim final for CY 2012 our CY 2011
interim values with a 10 percent
reduction in work efficiencies.
Specifically, for CY 2012, we are
assigning the following interim final
work RVUs for the following CPT codes:
2.72 for CPT code 93451 (Right heart
catheterization including
measurement(s) of oxygen saturation
and cardiac output, when performed),
4.75 for CPT code 93452 (Left heart
catheterization including
intraprocedural injection(s) for left
ventriculography, imaging supervision
and interpretation, when performed),
6.24 for CPT code 93453 (Combined
right and left heart catheterization
including intraprocedural injection(s)
for left ventriculography, imaging
supervision and interpretation, when
performed), 4.79 for CPT code 93454
(Catheter placement in coronary
artery(s) including intraprocedural
injection(s) for coronary angiography,
imaging supervision and interpretation),
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intraprocedural injection(s) for left
ventriculography, when performed,
catheter placement(s) in bypass graft(s)
(internal mammary, free arterial, venous
grafts) with bypass graft angiography),
7.35 for CPT code 93460 (Catheter
placement in coronary artery(s)
including intraprocedural injection(s)
for coronary angiography, imaging
supervision and interpretation with
right and left heart catheterization
including intraprocedural injection(s)
for left ventriculography, when
performed), 8.10 for CPT code 93461
(Catheter placement in coronary
artery(s) including intraprocedural
injection(s) for coronary angiography,
imaging supervision and interpretation
with right and left heart catheterization
including intraprocedural injection(s)
for left ventriculography, when
performed, catheter placement(s) in
bypass graft(s) (internal mammary, free
arterial, venous grafts) with bypass graft
angiography), 1.11 for CPT code 93563
(Injection procedure during cardiac
catheterization including image
supervision, interpretation, and report;
for selective coronary angiography
during congenital heart catheterization),
1.13 for CPT code 93564 (Injection
procedure during cardiac
catheterization including image
supervision, interpretation, and report;
for selective coronary angiography
during congenital heart catheterization
for selective opacification of
aortocoronary venous or arterial bypass
graft(s) (e.g., aortocoronary saphenous
vein, free radial artery, or free mammary
artery graft) to one or more coronary
arteries and in situ arterial conduits
(e.g., internal mammary), whether
native or used for bypass to one or more
coronary arteries during congenital
heart catheterization, when performed),
0.86 for CPT code 93565 (Injection
procedure during cardiac
catheterization including image
supervision, interpretation, and report;
for selective coronary angiography
during congenital heart catheterization
for selective left ventricular or left
arterial angiography), 0.86 for CPT code
93566 (Injection procedure during
cardiac catheterization including image
supervision, interpretation, and report;
for selective coronary angiography
during congenital heart catheterization
for selective right ventricular or right
atrial angiography), 0.97 for CPT code
93567 (Injection procedure during
cardiac catheterization including image
supervision, interpretation, and report;
for selective coronary angiography
during congenital heart catheterization
for supravalvular aortography), and 0.88
for CPT code 93568 (Injection procedure
during cardiac catheterization including
image supervision, interpretation, and
report; for selective coronary
angiography during congenital heart
catheterization for pulmonary
angiography).
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
(21) Pulmonary: Other Procedures (CPT
Codes 94060, 94726–94729, 94780 and
94781)
We identified CPT code 94060
through the MPC List screen. The AMA
RUC Relativity Assessment Workgroup
identified CPT codes 94240, 94260,
94350, 94360, 94370, and 94725 through
the Codes Reported Together 75 percent
or More screen. These codes are
commonly billed together with CPT
code 94720, 94360, 94240, and 94350.
For CY 2012, the specialty society
submitted a codes change proposal to
the CPT Editorial Panel to bundle the
services commonly reported together.
As a result, CPT created CPT codes
94726, 94727, 94728, and 94729. For CY
2012, CPT also created CPT codes 94780
and 94781 to report car seat testing
administered to the patient in the
private physician’s office.
After clinical review, we determined
that CPT codes 94060 (Bronchodilation
responsiveness, spirometry as in 94010,
pre- and post-bronchodilator
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5.54 for CPT code 93455 (with catheter
placement(s) in bypass graft(s) (internal
mammary, free arterial, venous grafts)
including intraprocedural injection(s)
for bypass graft angiography with
catheter placement(s) in bypass graft(s)
(internal mammary, free arterial, venous
grafts) including intraprocedural
injection(s) for bypass graft
angiography), 6.15 for CPT code 93456
(Catheter placement in coronary
artery(s) including intraprocedural
injection(s) for coronary angiography,
imaging supervision and interpretation
with right heart catheterization), 6.89 for
CPT code 93457 (Catheter placement in
coronary artery(s) including
intraprocedural injection(s) for coronary
angiography, imaging supervision and
interpretation with catheter
placement(s) in bypass graft(s) (internal
mammary, free arterial, venous grafts)
including intraprocedural injection(s)
for bypass graft angiography and right
heart catheterization), 5.85 for CPT code
93458 (Catheter placement in coronary
artery(s) including intraprocedural
injection(s) for coronary angiography,
imaging supervision and interpretation
with left heart catheterization including
intraprocedural injection(s) for left
ventriculography, when performed),
6.60 for CPT code 93459 (Catheter
placement in coronary artery(s)
including intraprocedural injection(s)
for coronary angiography, imaging
supervision and interpretation with left
heart catheterization including
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this value is further supported by CPT
code 97012 (Application of a modality
to 1 or more areas; traction, mechanical)
(work RVU=0.25) which has similar
time and intensity. The AMA RUC
recommended a work RVU of 0.31 for
CPT codes 94060, 94726, 94727, and
94728, which corresponded to each
surveys 25th percentile work RVU. We
are assigning a work RVU of 0.26 to CPT
codes 94060, 94726, 94727, and 94728
on an interim final basis for CY 2012.
After clinical review of CPT code
94729 (Diffusing capacity (e.g., carbon
monoxide, membrane) (List separately
in addition to code for primary
procedure)), we believe that a work RVU
of 0.17 accurately reflects the work
associated with this service. Based on
comparison to similar services, the
AMA RUC recommended a work RVU
of 0.19 for CPT code 94729. We believe
that CPT code 94010 (Spirometry,
including graphic record, total and
timed vital capacity, expiratory flow
rate measurement(s), with or without
maximal voluntary ventilation) (work
RVU=0.17) is similar in time and
intensity to CPT code 94729, and that
the codes should have the same work
RVU. Therefore, we are assigning a work
RVU of 0.17 to CPT code 94729 on an
interim final basis for CY 2012.
For the CY 2012 new, revised, and
potentially misvalued CPT codes
reviewed in this family of services and
not specifically discussed here, we agree
with the AMA RUC/HCPACrecommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
CPT codes 95860, 95861, 95863 and
95864 were identified by the AMA RUC
Relativity Assessment Workgroup
through the Codes Reported Together 75
percent or More screen. These codes are
billed commonly with CPT code 95904.
The specialty societies submitted a code
change proposal to the CPT Editorial
Panel to bundle the services commonly
reported together. For CY 2012, the CPT
Editorial Panel created 3 new add-on
procedure codes: CPT codes 95885,
95886, and 95887. The CPT Editorial
Panel noted, and the AMA RUC agreed,
that these 3 new codes were approved
with the intent that the specialties will
take additional time and bring forward
a more comprehensive coding solution
which bundles services commonly
performed together for CY 2013.
We reviewed CPT codes 95885
(Needle electromyography, each
extremity, with related paraspinal areas,
when performed, done with nerve
conduction, amplitude and latency/
velocity study; limited), 95886 (Needle
electromyography, each extremity with
related paraspinal areas when
performed, done with nerve conduction,
amplitude and latency/velocity study;
complete, five or more muscles studied,
innervated by three or more nerves or
four or more spinal levels), 95887
(Needle electromyography, non-
extremity (cranial nerve supplied or
axial) muscle(s) done with nerve
conduction, amplitude and latency/
velocity study), and are accepting the
AMA RUC-recommended work RVUs
and times on an interim basis, pending
review of the other electromyography
services for CY 2012. On an interim
basis for CY 2012 we are assigning a
work RVU of 0.35 to CPT code 95885,
a work RVU of 0.92 to CPT code 95886,
and a work RVU of 0.73 to CPT code
95887.
(22) Neurology and Neuromuscular
Procedures: Nerve Conduction Tests
(CPT Codes 95885–95887)
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(23) Neurology and Neuromuscular
Procedures: Autonomic Function Tests
(CPT Codes 95938 and 95939)
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administration), 94726
(Plethysmography for determination of
lung volumes and, when performed,
airway resistance), 94727 (Gas dilution
or washout for determination of lung
volumes and, when performed,
distribution of ventilation and closing
volumes), and 94728 (Airway resistance
by impulse oscillometry), involve very
similar work and should have the same
work RVU. CPT code 94240 (Functional
residual capacity or residual volume:
helium method, nitrogen open circuit
method, or other method) (work
RVU=0.26) is being deleted for CY 2012
and the utilization associated with that
service is expected to be captured under
new CPT codes 94726 and 92727. We
believe that a work RVU of 0.26
appropriately reflects the work
associated with CPT codes 94060,
94726, 94727, and 94728. We believe
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CPT code pairs 95925/95926 and
95928/95929 were identified by the
AMA RUC Relativity Assessment
Workgroup Codes Reported Together 75
percent or More screen. For CY 2012,
the CPT Editorial Panel created CPT
code 95938 to capture the reporting of
CPT codes 95925 and 95926 together,
and CPT codes 95939 to capture the
reporting CPT codes 95928 and 95929
together. The specialty society had
obtained valid survey results for CPT
code 95938 but not for 95939, as only
31 percent of the respondents indicated
the vignette was typical. The AMA RUC
and specialty societies agreed that a new
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survey should be conducted for CY
2013.
We reviewed CPT codes 95938 (Shortlatency somatosensory evoked potential
study, stimulation of any/all peripheral
nerves or skin sites, recording from the
central nervous system; in upper and
lower limbs) and 95939 (Motor evoked
potential study; in upper and lower
limbs), and are accepting the AMA
RUC-recommended work RVUs and
times on an interim basis, pending
resurvey of CPT code 95939. We also
request that the AMA RUC review the
component CPT codes 95925, 95926,
95928, and 95929. On an interim basis
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for CY 2012 we are assigning a work
RVU of 0.86 to CPT code 95938, and a
work RVU of 2.25 to CPT code 95939.
(24) Other CY 2012 New, Revised, and
Potentially Misvalued CPT Codes Not
Specifically Discussed Previously
For all other CY 2012 new, revised,
and potentially misvalued CPT codes
not specifically discussed previously,
we agree with the AMA RUC/HCPAC
recommended work RVUs and are
setting as interim final the work RVUs
listed in Table 19.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
2. Establishing Interim Final Direct PE
RVUs for CY 2012
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a. Background
The AMA RUC provides CMS with
recommendations regarding direct PE
inputs, including clinical labor,
supplies, and equipment, for new,
revised, and potentially misvalued
codes. We review the AMA RUCrecommended direct PE inputs on a
code-by-code basis, including the
recommended facility PE inputs and/or
nonfacility PE inputs, as clinically
appropriate for the code. We determine
whether we agree with the AMA RUC’s
recommended direct PE inputs for a
service or, if we disagree, we refine the
PE inputs to represent inputs that better
reflect our estimate of the PE resources
required for the service in the facility
and/or nonfacility settings. We also
confirm that CPT codes should have
facility and/or nonfacility direct PE
inputs and make changes based on our
clinical judgment and any PFS payment
policies that would apply to the code.
b. Methodology
We have accepted for CY 2012, as
interim final and without refinement,
the direct PE inputs based on the
recommendations submitted by the
AMA RUC for the codes listed in Table
20. For the remainder of the AMA
RUC’s direct PE recommendations, we
have accepted the PE recommendations
submitted by the AMA RUC as interim
final, but with refinements. These codes
and the refinements to their direct PE
inputs are listed in Table 21.
Generally, we only establish interim
final direct PE inputs for services when
the RUC has provided a new
recommendation. For CY 2012, we are
establishing interim final direct PE
inputs for several codes for which the
RUC did not provide direct PE
recommendations. In the case of these
codes, we believe it is necessary to
establish new interim final direct PE
inputs for codes not recently reviewed
by the RUC for the same reasons we
explain in greater detail in section II.B
(‘‘Potentially Misvalued Services Under
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the Physician Fee Schedule’’) of this
final rule with comment period: In order
to maintain appropriate relativity among
those codes and other related codes or
between the PE and work components
of PFS payment. There are two
situations that have prompted us to
establish interim final direct PE inputs
for particular codes without a
corresponding direct PE
recommendation from the RUC.
The first situation occurs when the
direct PE inputs of new, combined
codes are developed without parallel
review of the direct PE inputs of the
component codes that describe the same
services. For CY 2012, this situation
applies to three sets of codes. CPT has
created a new code, 74174, to describe
CTA of the abdomen and pelvis. Prior
to CY 2012, practitioners would have
reported the combined service using
two separate codes (74175 to describe
CTA of the abdomen and 72191 to
describe CTA of the pelvis). CPT
similarly created a new combined code
to describe short latency somatosensory
evoked potential studies of the upper
and lower limbs (95938). This combined
service would have been previously
reported using CPT codes 95925 (short
latency somatosensory evoked potential
studies of the upper limbs) and 95926
(short latency somatosensory evoked
potential studies of the lower limbs).
Finally, CPT created 95939 to describe
central motor evoked potential study of
the upper and lower limbs. This
combined service would have been
previously reported using component
CPT codes 95928 (central motor evoked
potential study of the upper limbs) and
95929 (central motor evoked potential
study of the lower limbs).
Since each of these sets of component
and combined codes is used to report
the same service, we believe that it is
important to maintain relativity among
the associated practice expense values.
We received direct PE recommendations
from the RUC for the new codes
describing combined services, but we
did not receive corresponding
recommendations regarding the existing
codes describing the component
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services. The new direct PE inputs for
the combined services are not fully
congruent with the current direct PE
inputs for the component codes.
Therefore, maintaining the direct PE
inputs for the existing component codes
until we receive a RUC recommendation
would result in at least one year of
incongruent practice expense values.
Therefore, we believe that it would be
inappropriate to develop PE values for
these sets of codes based on these
inputs. Since we do not have
corresponding recommendations
regarding the existing component codes,
we cannot maintain appropriate
relativity among the codes without
either refining the direct PE inputs of
the new combined codes to conform to
the existing component codes or
refining the direct PE inputs of the
existing component codes to conform to
the direct PE inputs of the new
combined codes. The direct PE inputs
for each of the existing component
codes were developed over 5 years ago.
Since the direct PE inputs for the new
combined codes were developed more
recently, we believe that they better
reflect current typical practice.
Therefore, in order to maintain
appropriate relativity among these sets
of codes that describe the same services
and in order to use the most accurate
information available, we used the
direct PE inputs for the new, combined
codes in order to develop appropriate
refinements to the direct PE inputs for
the existing, component codes. The
refinements to the current PE inputs for
these codes are included in Table 21
and they will be considered interim
final for CY 2012. In conjunction with
our request for comprehensive review of
code families as described in section
II.B. of this final rule with comment
period, we encourage the RUC to review
component codes when developing
recommendations regarding combined
codes.
The second situation arises when the
physician work values of particular
codes are reviewed as part of the
potentially misvalued code initiative
without parallel review of the
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corresponding direct PE inputs. In these
cases, we have reviewed the existing
direct PE inputs of the services in the
context of the new physician work and
time recommendations and, when
appropriate, established refined interim
final direct PE inputs consistent with
existing policies. These codes are: 70470
(Computed tomography, head or brain;
without contrast material, followed by
contrast material(s) and further
sections), 73030 (Radiologic
examination, pelvis; 1 or 2 views),
73030 (Radiologic examination,
shoulder; complete, minimum of 2
views), 73620 (Radiologic examination,
foot; 2 views), and 93971 (Duplex scan
of extremity veins including responses
to compression and other maneuvers;
unilateral or limited study). We are
adopting on an interim final basis for
CY 2012 the refinements to the current
direct PE inputs for these codes as
shown in Table 21, and these values are
reflected in the CY 2012 PFS direct PE
database. That database is available
under downloads for the CY 2012 PFS
final rule with comment period on the
CMS Web site at: https://www.cms.gov/
PhysicianFeeSched/PFSFRN/
list.asp#TopOfPage.
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c. Common and Code-Specific
Refinements
While Table 21 details the CY 2012
refinements of the AMA RUC’s direct PE
recommendations at the code-specific
level, we discuss the general nature of
some common refinements and the
reasons for particular refinements in the
following section.
(1) Changes in Physician Time
Some direct PE inputs are directly
affected by revisions in physician time
described in section III.B.1 of this final
rule with comment period. Specifically,
changes in the intra-service portions of
the physician time and changes in the
number or level of postoperative visits
associated with the global periods result
in corresponding changes to direct PE
inputs.
Changes in Intra-service Physician
Time in the Nonfacility Setting. For
most codes valued in the nonfacility
setting, a portion of the clinical labor
time allocated to the intra-service period
reflects minutes assigned for assisting
the physician with the procedure. To
the extent that we are refining the times
associated with the intra-service portion
of such procedures, we have adjusted
the corresponding intra-service clinical
labor minutes in the nonfacility setting.
For equipment associated with the
intra-service period in the nonfacility
setting, we generally allocate time based
on the typical number of minutes a
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piece of equipment is being used and,
therefore, not available for use with
another patient during that period. In
general, we allocate these minutes based
on the description of typical clinical
labor activities. To the extent that we
are making changes in the clinical labor
times associated with the intra-service
portion of procedures, we have adjusted
the corresponding equipment minutes
associated with the codes.
Changes in the Number or Level of
Postoperative Office Visits in the Global
Period. For codes valued with postservice physician office visits during a
global period, most of the clinical labor
time allocated to the post-service period
reflects a standard number of minutes
allocated for each of those visits. To the
extent that we are refining the number
or level of postoperative visits, we have
modified the clinical staff time in the
post-service period to reflect the change.
For codes valued with post-service
physician office visits during a global
period, we allocate standard equipment
for each of those visits. To the extent
that we are making a change in the
number or level of postoperative visits
associated with a code, we have
adjusted the corresponding equipment
minutes. For codes valued with postservice physician office visits during a
global period, a certain number of
supply items are allocated for each of
those office visits. To the extent that we
are making a change in the number of
postoperative visits, we have adjusted
the corresponding supply item
quantities associated with the codes. We
note that many supply items associated
with post-service physician office visits
are allocated for each office visit (for
example, a minimum multi-specialty
visit pack (SA048) in the CY 2012 direct
PE database). For these supply items,
the quantities in the direct PE database
should reflect the number of office visits
associated with the code’s global period.
However, some supply items are
associated with post-service physician
office visits but are only allocated once
during the global period because they
are typically used during only one of the
post-service office visits (for example,
pack, post-op incision care (suture)
(SA054) in the direct PE database). For
these supply items, the quantities in the
proposed notice direct PE database
reflect that single quantity.
These refinements are reflected in the
final CY 2011 PFS direct PE database
and detailed in Table 21.
(2) Equipment Minutes
In general, the equipment time inputs
correspond to the intra-service portion
of the clinical labor times. Certain
highly technical pieces of equipment
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and equipment rooms are less likely to
be used by a clinician over the full
course of a procedure and are typically
available for other patients during time
that may still be in the intra-service
portion of the service. We adjust those
equipment times accordingly. We refer
interested stakeholders to our extensive
discussion of these policies in the
context of our CY 2011 interim final
direct PE inputs in section III.B.2 of this
final rule with comment period. We are
refining the CY 2012 AMA RUC direct
PE recommendations to conform to
these equipment time policies. These
refinements are reflected in the final CY
2011 PFS direct PE database and
detailed in Table 21.
(3) Moderate Sedation Inputs
In section II.A.3 of this final rule with
commenter period, we finalized a
standard package of direct PE inputs for
services where moderate sedation is
considered inherent in the procedure.
We refer interested parties to our
extensive discussion of these policies as
proposed and finalized in section III.A.3
of this final rule with comment period.
We are refining the CY 2012 AMA RUC
direct PE recommendations to conform
to these policies. These refinements are
reflected in the final CY 2012 PFS direct
PE database and detailed in Table 21.
(4) Standard Minutes for Clinical Labor
Tasks
In general, the minutes associated
with certain clinical labor tasks are
standardized depending on the type of
procedure, its typical setting, its global
period, and the other procedures with
which it is typically reported. In the
case of some services, the RUC has
recommended a numbers of minutes
either greater or lesser than time
typically allotted for certain tasks. In
those cases, CMS clinical staff has
reviewed the deviations from the
standards to determine their clinical
appropriateness. Where the
recommended exceptions have not been
accepted, we have refined the interim
final direct PE inputs to match the
standard times for those tasks and each
of those refinements appears in Table
21.
(5) Supply and Equipment Invoices
When clinically appropriate, the
AMA RUC generally recommends the
use of supply and equipment items that
already exist in the direct PE database
for new, revised, and potentially
misvalued codes. Some
recommendations include supply or
equipment items that are not currently
in the direct PE database. In these cases,
the AMA RUC has historically
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recommended a new item be created
and has facilitated CMS’ pricing of that
item by working with the specialty
societies to provide sales invoices to us.
We appreciate the contributions of the
AMA RUC in that process.
We received invoices for several new
supply and equipment items for CY
2012. We have accepted each of these
items and added them to the direct PE
database. In general, the prices listed on
the submitted invoices match the items
listed in the RUC direct PE
recommendations. However, in some
cases, the relationship between
submitted invoices and the items listed
on the direct PE recommendations is not
clear. For example, some submitted
invoices only list total charges that
include all of the line items on the
invoice, including charges for costs
other than the price of the equipment
listed on the recommendation. When
the price for all of those line items is
apparent, we subtract that amount from
the total charges to determine the
appropriate price of the equipment. For
example, equipment item invoices often
include line items reflecting a limited
quantity of disposable supplies for use
during procedures. When these supplies
are built into the overall price of the
equipment and they also appear as
direct PE inputs, we subtract the price
of the supplies from the overall price of
the equipment since we have an
empirical basis for determining the
price of the excluded line item and the
price of those supplies is built into the
payment rate for the service. When we
have no way of determining how much
of the total price listed on the invoice
includes amounts attributed to excluded
line items, we cannot accept the invoice
as acceptable information to establish or
update a price input. In terms of the CY
2012 direct PE recommendations, we
point out that while we have accepted
the RUC’s recommendation for direct PE
inputs for SBRT treatment delivery, we
could not accept the accompanying
invoices to update the price of the ‘‘SRS
system, SBRT, six systems, average’’
equipment (ER083). Each of these
invoices included line items that we
would not accept as part of the cost of
the equipment, such as costs for training
technologists to use the equipment, and
the price for these items were not
separately identifiable. Therefore, we
did not update the equipment price for
ER083 in establishing interim final
direct PE inputs for CY 2012.
(6) Application of Casts and Strapping
(CPT codes 29581–29584)
The RUC recommended establishing a
new supply input for CPT codes 29582
(Application of multi-layer venous
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wound compression system, below
knee; thigh and leg, including ankle and
foot, when performed), 29583
(Application of multi-layer venous
wound compression system, below
knee; upper arm and forearm), and
29584 (Application of multi-layer
venous wound compression system,
below knee; upper arm, forearm, hand,
and fingers). Accompanying the RUC
recommendations, we received an
invoice that reflected a price of $16.39
per system when purchased as part of
case of eight. In response to this
recommendation, we have created a
supply item called ‘‘multi-layer
compression system bandages’’ (SG096)
with a price input of $16.39. As
discussed in section III.B.1.b. of this
final rule for comment period, for CY
2012 the CPT Editorial Panel revised the
descriptor for CPT code 29581
(Application of multi-layer compression
system; leg (below knee), including
ankle and foot), and also created CPT
codes 29582, 29583, and 29584 to
describe the application of multi-layer
compression to the upper and lower
extremities. The CPT Editorial Panel
and AMA RUC concluded that the
revisions to the descriptor for CPT code
29581 were editorial only, and the
specialty society believed that
resurveying CPT code 29581 was not
necessary. As such, the AMA RUC did
not review the direct PE inputs for CPT
code 29581. After clinical review, we
believe that CPT codes 29581, 29582,
29583, and 29584 all describe similar
services from a resource perspective. In
line with this determination, we are
treating all four codes as physical
therapy services and replacing the
supply input called ‘‘dressing, multi
layer system, venous ulcer’’ (SG093) in
29581 with the new supply item ‘‘multilayer compression system bandages’’
(SG096) on an interim basis for CY
2012.In section III.B.1.b (Establishing
Interim final RVUs for CY 2012) of this
CY 2012 PFS final rule, we believe that
a survey that addresses all 4 CPT codes
together as a family and gathers
responses from all clinicians who
furnish the services described by CPT
codes 29581 through 29584 would help
assure the appropriate gradation in
valuation of these 4 services Therefore,
for CY 2012 we are holding the work,
practice expense, and malpractice
values interim.
(7) Image Guidance for Biopsies
The RUC submitted direct PE inputs
for CPT codes CPT codes 47000 (Biopsy
of liver, needle; percutaneous) and
32405 (Biopsy, lung or mediastinum,
percutaneous needle) including minutes
allocated to a CT room. As reflected in
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Table 21, we refined both
recommendations to exclude the CT
room. For 47000, CPT instructs
practitioners to report separate codes
when image guidance is used to furnish
the service. Therefore, it would be
inappropriate to include the equipment
used for image guidance as a direct PE
input for 47000. For 32405, we note that
the recommendations for the new
nonfacility direct PE inputs for the code
were developed using the direct PE
inputs for recently CPT code 49083
(Abdominal paracentesis (diagnostic or
therapeutic); with imaging guidance)
and that code does not include use of a
CT room as a typically used resource.
These refinements are reflected in the
final CY 2012 PFS direct PE database.
(8) Extracranial Nerves, Peripheral
Nerves, and Autonomic Nervous System
For CY 2012, CPT created CPT
Editorial Panel deleted four codes and
created four new codes to describe
neurolysis reported per joint (2 nerves
per each joint) instead of per nerve
under image guidance. The new codes
are: 64633 (Destruction by neurolytic
agent, paravertebral facet joint nerve(s);
cervical or thoracic, with image
guidance (fluoroscopy or CT), single
facet joint); 64634 (Destruction by
neurolytic agent, paravertebral facet
joint nerve(s); cervical or thoracic, with
image guidance (fluoroscopy or CT),
each additional facet joint (List
separately in addition to code for
primary procedure)); 64635 (Destruction
by neurolytic agent, paravertebral facet
joint nerve(s); lumbar or sacral, with
image guidance (fluoroscopy or CT),
single facet joint); and 64636
(Destruction by neurolytic agent,
paravertebral facet joint nerve(s); lumbar
or sacral, with image guidance
(fluoroscopy or CT), each additional
facet joint (List separately in addition to
code for primary procedure)).
The RUC submitted direct practice
expense inputs for these new codes that
describe existing services. For codes
64633 and 64635, in addition to the
cannula (SD011), the radiofrequency
generator (EQ214), and other inputs, the
direct PE input recommendation
included a very expensive supply item
called ‘‘kit, probe, radiofrequency, XIienhanced RF probe’’ (SA100). The
recommendation did not provide a
rationale as to why this highly priced kit
should be included as a direct PE input
for these existing services when the four
predecessor codes that described the
services prior to CY 2012 included
neither this item nor any similarly
priced disposable supply. Therefore, we
are refining the RUC recommendation
by removing the supply item SA100
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consider any submitted information
regarding the use of this supply in
furnishing these services prior to
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2013.
BILLING CODE 4120–01–P
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are interim for CY 2012, and we will
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3. Establishing Interim Final
Malpractice RVUs for CY 2012
According to our malpractice
methodology discussed in section II.C.1.
of this final rule with comment period,
we have assigned malpractice RVUs for
CY 2012 new and revised codes by
utilizing a crosswalk to a source code
with a similar malpractice risk-ofservice. We have reviewed the AMA
RUC-recommended malpractice source
code crosswalks for CY 2012 new and
revised codes, and we are accepting
nearly all of them on an interim final
basis for CY 2012. For four CPT codes
describing multi-layer compression
systems, we are assigning a source code
crosswalk different from the source code
crosswalks recommended by the AMA
RUC and HCPAC.
For CPT codes 29582 (Application of
multi-layer venous wound compression
system, below knee; thigh and leg,
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including ankle and foot, when
performed), 29583 (Application of
multi-layer venous wound compression
system, below knee; upper arm and
forearm), and 29584 (Application of
multi-layer venous wound compression
system, below knee; upper arm, forearm,
hand, and fingers), the AMA RUC
recommended a malpractice source
code crosswalk to CPT code 29540
(Strapping; ankle and/or foot). For CPT
codes 29582 and 29584 the HCPAC
recommended a malpractice source
code crosswalk to CPT code 97124
(Therapeutic procedure, 1 or more areas,
each 15 minutes; massage, including
effleurage, petrissage and/or tapotement
(stroking, compression, percussion)),
and for CPT code 29583 the HCPAC
recommended a malpractice source
code crosswalk to CPT code 97762
(Checkout for orthotic/prosthetic use,
established patient, each 15 minutes).
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In addition to providing
recommendations on malpractice source
code crosswalks, the AMA RUC also
provides recommendations to us on
utilization crosswalks, which are largely
used to estimate utilization shifts for
budget neutrality. CPT codes 29582,
29583, and 29584 are new for CY 2012.
The AMA RUC recommended, and we
agreed, that the estimated utilization for
CPT codes 29582, 29583, and 29584
would have previously been reported
using CPT code 97140 (Manual therapy
techniques (e.g., mobilization/
manipulation, manual lymphatic
drainage, manual traction), 1 or more
regions, each 15 minutes). After review,
we believe that CPT code 97140
provides the most appropriate
malpractice source code crosswalk for
CPT codes 29582, 29583, and 29584.
Therefore, we are assigning CPT code
97140 as the malpractice source code
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crosswalk for CPT codes 29582, 29583,
and 29584 on an interim basis for CY
2012.
As discussed in section III.B.1.b. of
this final rule with comment period, for
CY 2012 the CPT Editorial Panel revised
the descriptor for CPT code 29581
(Application of multi-layer compression
system; leg (below knee), including
ankle and foot), and also created CPT
codes 29582, 29583, and 29584 to
describe the application of multi-layer
compression to the upper and lower
extremities. The CPT Editorial Panel
and AMA RUC concluded that the
revisions to the descriptor for CPT code
29581 were editorial only, and the
specialty society believed that
resurveying CPT code 29581 was not
necessary. As such, the AMA RUC
issued a recommendation of ‘‘No
Change’’ to us for CPT code 29581. After
clinical review, we believe that CPT
codes 29581, 29582, 29583, and 29584
all describe similar services from a
resource perspective. In line with this
determination, we assigned CPT code
29581 the same interim work RVU as
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CPT code 29583. Because we find these
services to be so similar, to we also
believe that it is appropriate for CPT
codes 29581 and 29583 to have the same
malpractice source code crosswalk.
Therefore, we are assigning CPT code
97140 as the malpractice source code
crosswalk for CPT code 29581 on an
interim basis for CY 2012. In section
III.B.1.b. of this final rule with comment
period, we requested that the layer
compression systems family of services
be surveyed together and that the AMA
RUC and HCPAC review their
recommendations to us for these
services. For CY 2012 we are holding
the work, practice expense, and
malpractice values interim pending
resurvey and review.
In addition to changes to the AMA
RUC-recommended malpractice
crosswalk mentioned previously, we
also added HCPCS code G0451 to the
malpractice crosswalk. As discussed in
section III.B.1.b. of this final rule with
comment period, for CY 2012 we
created HCPCS code G0451
(Development testing, with
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interpretation and report, per
standardized instrument form) to
replace CPT code 96110 (Developmental
screening, with interpretation and
report, per standardized instrument
form), as CPT code 96110 will be
excluded from payment on the
physician fee schedule effective January
1, 2012. We assigned CPT code 96110 as
the malpractice source code crosswalk
for HCPCS code G0451.
In accordance with our malpractice
methodology, we have adjusted the
malpractice RVUs of the CY 2012 new/
revised codes for difference in work
RVUs (or, if greater, the clinical labor
portion of the fully implemented PE
RVUs) between the source code and the
new/revised code to reflect the specific
risk-of-service for the new/revised
codes. Table 22 lists the CY 2012 new/
revised CPT codes and their respective
source codes used to set the interim
final CY 2012 malpractice RVUs.
Revised CPT codes that are crosswalked
to themselves (that is, CPT code 27096
to 27096) are not listed.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
IV. Allowed Expenditures for
Physicians’ Services and the
Sustainable Growth Rate
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A. Medicare Sustainable Growth Rate
(SGR)
The SGR is an annual growth rate that
applies to physicians’ services paid by
Medicare. The use of the SGR is
intended to control growth in aggregate
Medicare expenditures for physicians’
services. Payments for services are not
withheld if the percentage increase in
actual expenditures exceeds the SGR.
Rather, the PFS update, as specified in
section 1848(d)(4) of the Act, is adjusted
based on a comparison of allowed
expenditures (determined using the
SGR) and actual expenditures. If actual
expenditures exceed allowed
expenditures, the update is reduced. If
actual expenditures are less than
allowed expenditures, the update is
increased.
Section 1848(f)(2) of the Act specifies
that the SGR for a year (beginning with
CY 2001) is equal to the product of the
following four factors:
(1) The estimated change in fees for
physicians’ services;
(2) The estimated change in the
average number of Medicare fee-forservice beneficiaries;
(3) The estimated projected growth in
real GDP per capita; and
(4) The estimated change in
expenditures due to changes in statute
or regulations.
In general, section 1848(f)(3) of the
Act requires us to publish SGRs for 3
different time periods, no later than
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November 1 of each year, using the best
data available as of September 1 of each
year. Under section 1848(f)(3)(C)(i) of
the Act, the SGR is estimated and
subsequently revised twice (beginning
with the FY and CY 2000 SGRs) based
on later data. (The Act also provides for
adjustments to be made to the SGRs for
FY 1998 and FY 1999. See the February
28, 2003 Federal Register (68 FR 9567)
for a discussion of these SGRs). Under
section 1848(f)(3)(C)(ii) of the Act, there
are no further revisions to the SGR once
it has been estimated and subsequently
revised in each of the 2 years following
the preliminary estimate. In this final
rule with comment, we are making our
preliminary estimate of the CY 2012
SGR, a revision to the CY 2011 SGR, and
our final revision to the CY 2010 SGR.
1. Physicians’ Services
Section 1848(f)(4)(A) of the Act
defines the scope of physicians’ services
covered by the SGR. The statute
indicates that ‘‘the term physicians’
services includes other items and
services (such as clinical diagnostic
laboratory tests and radiology services),
specified by the Secretary, that are
commonly performed or furnished by a
physician or in a physician’s office, but
does not include services furnished to a
Medicare+Choice plan enrollee.’’
We published a definition of
physicians’ services for use in the SGR
in the November 1, 2001 Federal
Register (66 FR 55316). We defined
physicians’ services to include many of
the medical and other health services
listed in section 1861(s) of the Act.
Since that time, the statute has been
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amended to add new Medicare benefits.
As the statute changed, we modified the
definition of physicians’ services for the
SGR to include the additional benefits
added to the statute that meet the
criteria specified in section
1848(f)(4)(A).
As discussed in the CY 2010 PFS final
rule with comment period (74 FR
61961), the statute provides the
Secretary with clear discretion to decide
whether physician-administered drugs
should be included or excluded from
the definition of ‘‘physicians’ services.’’
Accordingly, we removed physicianadministered drugs from the definition
of ‘‘physicians’ services’’ in section
1848(f)(4)(A) of the Act for purposes of
computing the SGR and the levels of
allowed expenditures and actual
expenditures beginning with CY 2010,
and for all subsequent years.
Furthermore, in order to effectuate fully
the Secretary’s policy decision to
remove drugs from the definition of
‘‘physicians’ services,’’ we removed
physician-administered drugs from the
calculation of allowed and actual
expenditures for all prior years.
Thus, for purposes of determining
allowed expenditures, actual
expenditures for all years, and SGRs
beginning with CY 2010 and for all
subsequent years, we are specifying that
physicians’ services include the
following medical and other health
services if bills for the items and
services are processed and paid by
Medicare carriers (and those paid
through intermediaries where specified)
or the equivalent services processed by
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73269
• Diagnostic x-ray tests, diagnostic
laboratory tests, and other diagnostic
tests (including outpatient diagnostic
laboratory tests paid through
intermediaries).
• X-ray, radium, and radioactive
isotope therapy.
• Surgical dressings, splints, casts,
and other devices used for the reduction
of fractures and dislocations.
• Bone mass measurements.
• An initial preventive physical
exam.
• Cardiovascular screening blood
tests.
• Diabetes screening tests.
• Telehealth services.
• Physician work and resources to
establish and document the need for a
power mobility device.
• Additional preventive services.
• Pulmonary rehabilitation.
• Cardiac rehabilitation.
• Intensive cardiac rehabilitation.
• Kidney disease education services.
• Personalized prevention plan
services.
3. Revised Sustainable Growth Rate for
CY 2011
Our current estimate of the CY 2011
SGR is 6.0 percent. Table 24 shows our
preliminary estimate of the CY 2011
SGR that was published in the CY 2011
PFS final rule with comment period (75
FR 73278) and our current estimate. The
majority of the difference between the
preliminary estimate and our current
estimate of the CY 2011 SGR is
explained by adjustments to reflect two
intervening legislative changes that have
occurred since publication of the CY
2011 final rule with comment period.
2. Preliminary Estimate of the SGR for
2012
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Our preliminary estimate of the CY
2012 SGR is ¥16.9 percent. We first
estimated the CY 2012 SGR in March
2011, and we made the estimate
available to the MedPAC and on our
Web site. Table 23 shows the March
2011 estimate and our current estimates
of the factors included in the CY 2012
SGR. The majority of the difference
between the March estimate and our
current estimate of the CY 2012 SGR is
explained by net adjustments that
reflect higher physician fees and fee-forservice enrollment after our March
estimate was prepared. Estimates of
2012 real per capita GDP are also lower
than were included in our March, 2011
estimate of the SGR.
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the Medicare Administrative
Contractors:
• Physicians’ services.
• Services and supplies furnished
incident to physicians’ services, except
for the expenditures for drugs and
biologicals which are not usually selfadministered by the patient.
• Outpatient physical therapy
services and outpatient occupational
therapy services.
• Services of PAs, certified registered
nurse anesthetists, certified nurse
midwives, clinical psychologists,
clinical social workers, nurse
practitioners, and certified nurse
specialists.
• Screening tests for prostate cancer,
colorectal cancer, and glaucoma.
• Screening mammography,
screening pap smears, and screening
pelvic exams.
• Diabetes outpatient selfmanagement training (DSMT) services.
• MNT services.
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4. Final Sustainable Growth Rate for CY
2010
The SGR for CY 2010 is 8.9 percent.
Table 25 shows our preliminary
5. Calculation of CYs 2012, 2011, and
2010 Sustainable Growth Rates
a. Detail on the CY 2012 SGR
All of the figures used to determine
the CY 2012 SGR are estimates that will
be revised based on subsequent data.
Any differences between these estimates
and the actual measurement of these
figures will be included in future
revisions of the SGR and allowed
expenditures and incorporated into
subsequent PFS updates.
(1) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2012
included in the SGR in CY 2012 and are
updated using the percent change in the
Medicare Economic Index (MEI). As
discussed in section IV.C. of this final
rule with comment period, the percent
change in the MEI for CY 2012 is 0.6
percent. Diagnostic laboratory tests are
estimated to represent approximately
10.6 percent of Medicare allowed
charges included in the SGR for CY
2012. Medicare payments for these tests
are updated by the Consumer Price
Index for Urban Areas (CPI–U), which is
3.6 percent for CY 2012. Section 3401(l)
of the Affordable Care Act requires the
Secretary to reduce the CPI–U update
applied to clinical laboratory tests under
the clinical laboratory fee schedule be
reduced by a multi-factor productivity
adjustment (MFP adjustment) and, for
each of years 2011 through 2015, by
1.75 percentage points (percentage
adjustment). The MFP adjustment will
not apply in a year where the CPI–U is
zero or a percentage decrease for a year.
Further, the application of the MFP
adjustment shall not result in an
adjustment to the fee schedule of less
than zero for a year. However, the
application of the percentage
adjustment may result in an adjustment
to the fee schedule being less than zero
for a year and may result in payment
rates for a year being less than such
payment rates for the preceding year.
The applicable productivity adjustment
for CY 2012 is 1.2 percent. Adjusting the
CPI–U update by the productivity
adjustment results in a 2.4 percent (3.6
percent (CPI–U)– 1.2 percent (MFP
adjustment) update for CY 2012.
However, the percentage reduction of
1.75 percent is applied for CYs 2011
through 2015, as discussed previously.
Therefore, for CY 2012, diagnostic
laboratory tests will receive an update of
0.7 percent (rounded). Table 26 shows
the weighted average of the MEI and
laboratory price changes for CY 2012.
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rule with comment period (75 FR
73278), and the final figures determined
using the best available data as of
September 1, 2011.
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This factor is calculated as a weighted
average of the CY 2012 changes in fees
for the different types of services
included in the definition of physicians’
services for the SGR. Medical and other
health services paid using the PFS are
estimated to account for approximately
89.4 percent of total allowed charges
estimate of the CY 2010 SGR from the
CY 2010 PFS final rule with comment
period (74 FR 61965), our revised
estimate from the CY 2011 PFS final
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73271
(2) Factor 2—The Percentage Change in
the Average Number of Part B Enrollees
From CY 2011 to CY 2012
This factor is our estimate of the
percent change in the average number of
fee-for-service enrollees from CY 2011
to CY 2012. Services provided to
Medicare Advantage (MA) plan
enrollees are outside the scope of the
SGR and are excluded from this
estimate. We estimate that the average
number of Medicare Part B fee-forservice enrollees will increase by 3.5
percent from CY 2011 to CY 2012. Table
27 illustrates how this figure was
determined.
An important factor affecting fee-forservice enrollment is beneficiary
enrollment in MA plans. Because it is
difficult to estimate the size of the MA
enrollee population before the start of a
CY, at this time we do not know how
actual enrollment in MA plans will
compare to current estimates. For this
reason, the estimate may change
substantially as actual Medicare fee-forservice enrollment for CY 2012 becomes
known.
in CY 2012 relative to CY 2011 are
estimated to have an impact on
expenditures of ¥20.7 percent. The
impact is primarily due to the
expiration of the physician fee schedule
update included in the Medicare and
Medicaid Extenders Act (MMEA) which
specified a physician fee schedule
update for CY 2011 only. Additionally,
section 3102 of the Affordable Care Act
revised the methodology for calculating
the PE GPCIs for CY 2010 and CY 2011
so that the employee compensation and
rent components of the PE GPCIs reflect
only one-half of the relative cost
differences for each locality compared
to the national average. This provision
included a hold harmless so that no
area’s GPCI could decline and was not
budget neutral. In addition, section 103
of the MMEA extended the floor of 1.0
on the work GPCI through the end of CY
2011. This provision was also not
budget neutral. The expiration of the
methodological changes to the PE GPCIs
and the floor of the work GPCI in CY
2012 will cause a reduction in spending
in CY 2012 compared to CY 2011.
different types of services included in
the definition of physicians’ services for
the SGR in CY 2011.
We estimate that services paid using
the PFS account for approximately 92.1
percent of total allowed charges
included in the SGR in CY 2011. These
services were updated using the CY
2011 percent change in the MEI of 0.4
percent. We estimate that diagnostic
laboratory tests represent approximately
7.9 percent of total allowed charges
included in the SGR in CY 2011.
Medicare payments for these tests are
updated by the CPI–U, which was 1.1
percent for CY 2011. However, section
3401(l)(2)(iv)(subclause I) of the
Affordable Care Act requires the
Secretary to reduce the CPI–U update
applied to clinical laboratory tests by a
productivity adjustment, but does not
allow the productivity adjustment to
result in a negative CLFS update. The
result is that the CLFS update for CY
2011 was 0.0 percent. Additionally,
section 3401(1)(2)(iv)(II) of the
Affordable Care Act reduces the update
applied to clinical laboratory tests by
1.75 percent for CYs 2011 through 2015.
Therefore, for CY 2011, diagnostic
laboratory tests received an update of
¥1.75 percent.
Table 28 shows the weighted-average
of the MEI and laboratory price changes
for CY 2011.
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(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
CY 2012
We estimate that the growth in real
GDP per capita from CY 2011 to CY
2012 will be 0.6 percent (based on the
annual growth in the 10 year moving
average of real GDP per capita (2003
through 2012)). Our past experience
indicates that there have also been
changes in estimates of real GDP per
capita growth made before the year
begins and the actual change in real
GDP per capita growth computed after
the year is complete. Thus, it is possible
that this figure will change as actual
information on economic performance
becomes available to us in CY 2012.
(4) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2012 Compared With
CY 2011
The statutory and regulatory
provisions that will affect expenditures
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b. Detail on the CY 2011 SGR
A more detailed discussion of our
revised estimates of the four elements of
the CY 2011 SGR follows.
(1) Factor 1—Changes in Fees for
Physicians’ Services for CY 2011
This factor was calculated as a
weighted-average of the CY 2011
changes in fees that apply for the
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We estimate that the weighted average
increase in fees for physicians’ services
in CY 2012 under the SGR will be 0.6
percent.
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(4) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2011 Compared With
CY 2010
(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
CY 2011
We estimate that the growth in real
GDP per capita will be 0.6 percent for
CY 2011 (based on the annual growth in
the 10-year moving average of real GDP
per capita (2002 through 2011)). Our
past experience indicates that there
have also been differences between our
estimates of real per capita GDP growth
made prior to the year’s end and the
actual change in this factor. Thus, it is
possible that this figure will change
further as complete actual information
on CY 2011 economic performance
becomes available to us in CY 2012.
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(2) Factor 2—The Percentage Change in
the Average Number of Part B Enrollees
From CY 2010 to CY 2011
We estimate that the average number
of Medicare Part B fee-for-service
The statutory and regulatory
provisions that affected expenditures in
CY 2011 relative to CY 2010 are
estimated to have an impact on
expenditures of 3.3 percent. These
include the Department of Defense
Appropriations Act (DODAA), the
Temporary Extension Act (TEA), and
the Preservation of Access to Care for
Medicare Beneficiaries and Pension
Relief Act (PACMBPRA) which
provided for physician fee schedule
updates. Furthermore, the Affordable
Care Act contained provisions regarding
the policy on equipment utilization for
imaging services, the multiple
procedure payment reduction policy for
imaging services, and the annual
wellness visit providing personalized
prevention plan services.
c. Detail on the CY 2010 SGR
A more detailed discussion of our
final revised estimates of the four
elements of the CY 2010 SGR follows.
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enrollees (excluding beneficiaries
enrolled in Medicare Advantage plans)
increased by 1.8 percent in CY 2011.
Table 29 illustrates how we determined
this figure.
(1) Factor 1—Changes in Fees for
Physicians’ Services for CY 2010
This factor was calculated as a
weighted-average of the CY 2010
changes in fees that apply for the
different types of services included in
the definition of physicians’ services for
the SGR in CY 2010.
We estimate that services paid under
the PFS account for approximately 91.3
percent of total allowed charges
included in the SGR in CY 2010. These
services were updated using the CY
2010 percent change in the MEI of 1.2
percent. We estimate that diagnostic
laboratory tests represent approximately
8.7 percent of total allowed charges
included in the SGR in CY 2010.
Medicare payments for these tests are
updated by the CPI–U, which was ¥1.4
percent for CY 2010. However, section
145 of the Medicare Improvements for
Patients and Providers Act (MIPPA),
reduced the update applied to clinical
laboratory tests by 0.5 percent for CY
2009 and CY 2010. Therefore, for CY
2010, diagnostic laboratory tests
received an update of ¥1.9 percent.
Since we removed physicianadministered drugs from the definition
of ‘‘physicians’ services’’ for purposes of
computing the SGR and the levels of
allowed expenditures and actual
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rule with comment period was 0.2
percent (75 FR 73279).
Our estimate of the 1.8 percent change
in the number of fee-for-service
enrollees, net of Medicare Advantage
enrollment for CY 2011 compared to CY
2010, is different than our original
estimate of an increase of 2.4 percent in
the CY 2011 PFS final rule with
comment period (75 FR 73279). While
our current projection based on data
from 8 months of CY 2011 differs from
our original estimate of 2.4 percent
when we had no actual data, it is still
possible that our final estimate of this
figure will be different once we have
complete information on CY 2011 feefor-service enrollment.
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After considering the elements
described in Table 28, we estimate that
the weighted-average increase in fees for
physicians’ services in CY 2011 under
the SGR was 0.2 percent. Our estimate
of this factor in the CY 2011 PFS final
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Table 30 shows the weighted-average
of the MEI and laboratory price changes
for CY 2010.
After considering the elements
described in Table 30, we estimate that
the weighted-average increase in fees for
physicians’ services in CY 2010 under
the SGR was 0.9 percent. This figure is
a final one based on complete data for
CY 2010.
(2) Factor 2—The Percentage Change in
the Average Number of Part B Enrollees
From CY 2009 to CY 2010
from CY 2009 to CY 2010 was 1.1
percent. Our calculation of this factor is
based on complete data from CY 2010.
Table 31 illustrates the calculation of
this factor.
(3) Factor 3—Estimated Real Gross
Domestic Product Per Capita Growth in
CY 2010
provisions regarding the physician fee
schedule update, PQRI and Eprescribing incentives, the work GPCIs,
and payment provisions related to
certain pathology services. Additionally,
the Affordable Care Act contained
provisions regarding the work GPCIs,
the policy on equipment utilization for
imaging services, coverage of preventive
services, and a physician enrollment
requirement.
We estimate that the growth in real
per capita GDP was 0.6 percent in CY
2010 (based on the annual growth in the
10-year moving average of real GDP per
capita (CYs 2001 through 2010)). This
figure is a final one based on complete
data for CY 2010.
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(d) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2010 Compared With
CY 2009
Our final estimate for the net impact
on expenditures from the statutory and
regulatory provisions that affect
expenditures in CY 2010 relative to CY
2009 is 6.1 percent. The statutory and
regulatory provisions that affected
expenditures in CY 2010 relative to CY
2009 include the DODAA, the TEA, and
the Preservation of Access to Care for
Medicare Beneficiaries and Pension
Relief Act (PACMBPRA) which
provided for physician fee schedule
updates. Also included are the MIPPA
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We estimate the change in the number
of fee-for-service enrollees (excluding
beneficiaries enrolled in MA plans)
B. The Update Adjustment Factor (UAF)
Section 1848(d) of the Act provides
that the PFS update is equal to the
product of the the UAF and the MEI.
The UAF is applied to make actual and
target expenditures (referred to in the
statute as ‘‘allowed expenditures’’)
equal. As discussed previously, allowed
expenditures are equal to actual
expenditures in a base period updated
each year by the SGR. The SGR sets the
annual rate of growth in allowed
expenditures and is determined by a
formula specified in section 1848(f) of
the Act.
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1. Calculation Under Current Law
Under section 1848(d)(4)(B) of the
Act, the UAF for a year beginning with
CY 2001 is equal to the sum of the
following—
• Prior Year Adjustment Component.
An amount determined by—
++ Computing the difference (which
may be positive or negative) between
the amount of the allowed expenditures
for physicians’ services for the prior
year (the year prior to the year for which
the update is being determined) and the
amount of the actual expenditures for
those services for that year;
++ Dividing that difference by the
amount of the actual expenditures for
those services for that year; and
++ Multiplying that quotient by 0.75.
• Cumulative Adjustment
Component. An amount determined
by—
++ Computing the difference (which
may be positive or negative) between
the amount of the allowed expenditures
for physicians’ services from April 1,
1996, through the end of the prior year
and the amount of the actual
expenditures for those services during
that period;
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allowed charges included in the SGR in
CY 2010 and later years.
ER28NO11.135</GPH>
expenditures beginning with CY 2010,
and for all subsequent years, drugs
represent 0.0 percent of Medicare
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and subsequently revised twice. The
second revision occurs after the CY has
ended (that is, we are making the
second revision to CY 2010 allowed
expenditures in this final rule with
comment).
Table 32 shows the historical SGRs
corresponding to each period through
CY 2012.
use allowed and actual expenditures
from April 1, 1996 through December
31, 2011 and the CY 2012 SGR.
Consistent with section 1848(d)(4)(E) of
the Act, we will be making revisions to
the CY 2011 and CY 2012 SGRs and CY
2011 and CY 2012 allowed
expenditures. Because we have
incomplete actual expenditure data for
CY 2011, we are using an estimate for
this period. Any difference between
current estimates and final figures will
be taken into account in determining the
UAF for future years.
We are using figures from Table 32 in
the following statutory formula:
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discussed previously, section 1848(f)(3)
specifies that the SGR (and, in turn,
allowed expenditures) for the upcoming
CY (CY 2012 in this case), the current
CY (that is, CY 2011) and the preceding
CY (that is, CY 2010) are to be
determined on the basis of the best data
available as of September 1 of the
current year. Allowed expenditures for
a year generally are estimated initially
Consistent with section 1848(d)(4)(E)
of the Act, Table 32 includes our second
revision of allowed expenditures for CY
2010, a recalculation of allowed
expenditures for CY 2011, and our
initial estimate of allowed expenditures
for CY 2012. To determine the UAF for
CY 2012, the statute requires that we
emcdonald on DSK4SPTVN1PROD with RULES2
++ Dividing that difference by actual
expenditures for those services for the
prior year as increased by the SGR for
the year for which the UAF is to be
determined; and
++ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act
requires the Secretary to recalculate
allowed expenditures consistent with
section 1848(f)(3) of the Act. As
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73275
UAF12 = Update Adjustment Factor
for CY 2012 = ¥4.0 percent
Target11 = Allowed Expenditures for
CY 2011 = $103.4 billion
Actual11 = Estimated Actual
Expenditures for CY 2011 = $101.1
billion
Target4/96–12/11 = Allowed
Expenditures for 4/1/1996–12/31/2011
= $1,118.7 billion
Actual4/96–12/11 = Estimated Actual
Expenditures from 4/1/1996–12/31/
2011 = $1,133.3 billion
SGR12 = ¥16.9 percent (0.831)
Section 1848(d)(4)(D) of the Act
indicates that the UAF determined
under section 1848(d)(4)(B) of the Act
for a year may not be less than ¥0.07
or greater than 0.03. Since ¥0.04 (¥4
percent) is between ¥0.07 and 0.03, the
UAF for CY 2012 will be ¥0.04.
Section 1848(d)(4)(A)(ii) of the Act
indicates that 1.0 should be added to the
UAF determined under section
1848(d)(4)(B) of the Act. Thus, adding
1.0 to ¥0.04 makes the UAF equal to
0.96.
The MEI measures the weightedaverage annual price change for various
inputs needed to produce physicians’
services. The MEI is a fixed-weight
input price index, with an adjustment
for the change in economy-wide
multifactor productivity. This index,
which has CY 2006 base year weights,
is comprised of two broad categories: (1)
Physician’s own time; and (2)
physician’s practice expense (PE).
The physician’s compensation (own
time) component represents the net
income portion of business receipts and
primarily reflects the input of the
physician’s own time into the
production of physicians’ services in
physicians’ offices. This category
consists of two subcomponents: (1)
Wages and salaries; and (2) fringe
benefits.
The physician’s practice expense (PE)
category represents nonphysician inputs
used in the production of services in
physicians’ offices. This category
consists of wages and salaries and fringe
benefits for nonphysician staff and other
nonlabor inputs. The physician’s PE
component also includes the following
categories of nonlabor inputs: Office
expenses; medical materials and
supplies; professional liability
insurance; medical equipment; medical
materials and supplies; and other
professional expenses.
Table 33 presents a listing of the MEI
cost categories with associated weights
and percent changes for price proxies
for the 2012 update. The CY 2012 final
MEI update is 1.8 percent and reflects
a 2.3 percent increase in physician’s
own time and a 1.4 percent increase in
physician’s PE. Within the physician’s
PE, the largest increase occurred in
chemicals, which increased 10.2
percent, and rubber and plastic
products, which increased 5.2 percent.
For CY 2012, the increase in the
productivity adjusted MEI is 0.6
percent, which reflects an increase in
the MEI of 1.8 percent and a
productivity adjustment of 1.2 percent
based on the 10-year moving average of
economy-wide private nonfarm business
multifactor productivity. The Bureau of
Labor Statistics (BLS) is the agency that
publishes the official measure of private
non-farm business MFP. Please see
https://www.bls.gov/mfp which is the
link to the BLS historical published data
on the measure of MFP.
emcdonald on DSK4SPTVN1PROD with RULES2
The MEI is authorized by section
1842(b)(3) of the Act, which states that
prevailing charge levels beginning after
June 30, 1973 may not exceed the level
from the previous year except to the
extent that the Secretary finds, on the
basis of appropriate economic index
data, that the higher level is justified by
year-to-year economic changes. The
current form of the MEI was detailed in
the CY 2011 PFS final rule with
comment period (75 FR 73262) which
updated the cost structure of the index
from a base year of 2000 to 2006.
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C. The Percentage Change in the
Medicare Economic Index (MEI)
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D. Physician and Anesthesia Fee
Schedule Conversion Factors for CY
2012
The CY 2012 PFS CF is $24.6712. The
CY 2012 national average anesthesia CF
is $15.5264.
1. Physician Fee Schedule Update and
Conversion Factor
a. CY 2012 PFS Update
The formula for calculating the PFS
update is set forth in section
1848(d)(4)(A) of the Act. In general, the
PFS update is determined by
multiplying the CF for the previous year
by the percentage increase in the MEI
times the UAF, which is calculated as
specified under section 1848(d)(4)(B) of
the Act.
b. CY 2012 PFS Conversion Factor
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Generally, the PFS CF for a year is
calculated in accordance with section
1848(d)(1)(A) of the Act by multiplying
the previous year’s CF by the PFS
update.
We note section 101 of the Medicare
Improvements and Extension Act,
Division B of the Tax Relief and Health
Care Act of 2006 (MIEA–TRHCA)
provided a 1-year increase in the CY
2007 CF and specified that the CF for
CY 2008 must be computed as if the 1year increase had never applied. Section
101 of the Medicare, Medicaid, and
SCHIP Extension Act of 2007 (MMSEA)
provided a 6-month increase in the CY
2008 CF, from January 1, 2008, through
June 30, 2008, and specified that the CF
We note payment for services under
the PFS will be calculated as follows:
Payment = [(RVU work × GPCI work) +
(RVU PE × GPCI PE) + (RVU
malpractice × GPCI malpractice)] ×
CF.
2. Anesthesia Conversion Factor
We calculate the anesthesia CF as
indicated in Table 35. Anesthesia
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for the remaining portion of CY 2008
and the CFs for CY 2009 and subsequent
years must be computed as if the 6month increase had never applied.
Section 131 of the MIPPA extended the
increase in the CY 2008 CF that applied
during the first half of the year to the
entire year, provided for a 1.1 percent
increase to the CY 2009 CF, and
specified that the CFs for CY 2010 and
subsequent years must be computed as
if the increases for CYs 2007, 2008, and
2009 had never applied. Section 1011(a)
of the DODAA and section 5 of the TEA
specified a zero percent update for CY
2010, effective January 1, 2010 through
March 31, 2010. Section 4 of the
Continuing Extension Act of 2010 (CEA)
extended the zero percent update for CY
2010 through May 31, 2010.
Subsequently, section 101(a)(2) of the
PACMBPRA provided for a 2.2 percent
update to the CF, effective from June 1,
2010 to November 30, 2010. Section 2
of the Physician Payment and Therapy
Relief Act of 2010 (Pub. L. 111–286)
extended the 2.2 percent through the
end of CY 2010. Finally, section 101 of
the MMEA provided a zero percent
update for CY 2011, effective January 1,
2011 through December 31, 2011, and
specified that the CFs for CY 2012 and
subsequent years must be computed as
if the increases in previous years had
never applied. Therefore, under current
law, the CF that would be in effect in
CY 2011 had the prior increases
specified above not applied is $25.4999.
In addition, when calculating the PFS
CF for a year, section 1848(c)(2)(B)(ii)(II)
of the Act requires that increases or
decreases in RVUs may not cause the
amount of expenditures for the year to
differ more than $20 million from what
it would have been in the absence of
these changes. If this threshold is
exceeded, we must make adjustments to
preserve budget neutrality. We estimate
that CY 2012 RVU changes would result
in a decrease in Medicare physician
expenditures of more than $20 million.
Accordingly, we are increasing the CF
by 1.0018 to offset this estimated
decrease in Medicare physician
expenditures due to the CY 2012 RVU
changes. We calculate the CY 2012 PFS
CF to be $24.6712. This final rule with
comment period announces a reduction
to payment rates for physicians’ services
in CY 2012 under the SGR formula.
These payment rates are currently
scheduled to be reduced under the SGR
system on January 1, 2012. The total
reduction in MPFS rates between CY
2011 and CY 2012 under the SGR
system will be 27.4 percent. By law, we
are required to make these reductions in
accordance with section 1848(d) and (f)
of the Act, and these reductions can
only be averted by an Act of Congress.
While Congress has provided temporary
relief from these reductions every year
since 2003, a long-term solution is
critical. We will continue to work with
Congress to fix this untenable situation
so doctors and beneficiaries no longer
have to worry about the stability and
adequacy of their payments from
Medicare under the Physician Fee
Schedule.
We illustrate the calculation of the CY
2012 PFS CF in Table 34.
services do not have RVUs like other
PFS services. Therefore, we account for
any necessary RVU adjustments through
an adjustment to the anesthesia CF to
simulate changes to RVUs. More
specifically, if there is an adjustment to
the work, PE, or malpractice RVUs,
these adjustments are applied to the
respective shares of the anesthesia CF as
these shares are proxies for the work,
PE, and malpractice RVUs for anesthesia
services. Information regarding the
anesthesia work, PE, and malpractice
shares can be found at the following:
https://www.cms.gov/center/anesth.asp.
The anesthesia CF in effect in CY
2011 is $21.0515. As explained
previously, in order to calculate the CY
2012 PFS CF, the statute requires us to
calculate the CFs for all previous years
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2011 had statutory increases not applied
is $15.8085. The percent change from
the anesthesia CF in effect in CY 2011
($21.0515) to the CF for CY 2012
($15.5264) is –26.2 percent. We
illustrate the calculation of the CY 2012
anesthesia CF in Table 35.
V. Other Physician Fee Schedule Issues
independent laboratory’s pathologist
furnishes the PC service, the PC service
is usually billed with the TC service as
a combined service.
Historically, any independent
laboratory could bill the Medicare
contractor under the PFS for the TC of
physician pathology services for
hospital patients even though the
payment for the costs of furnishing the
pathology service (but not its
interpretation) was already included in
the bundled inpatient stay payment to
the hospital. In the CY 2000 PFS final
rule with comment period (64 FR 59408
and 59409), we stated that this policy
has contributed to the Medicare
program paying twice for the TC service:
(1) To the hospital, through the
inpatient prospective payment rate,
when the patient is an inpatient; and (2)
to the independent laboratory that bills
the Medicare contractor, instead of the
hospital, for the TC service. While the
policy also permits the independent
laboratory to bill for the TC of physician
pathology services for hospital
outpatients, in this case, there generally
would not be duplicate payment
because we would expect the hospital to
not also bill for the pathology service,
which would be paid separately to the
hospital only if the hospital were to
specifically bill for it. We further
indicated that we would implement a
policy to pay only the hospital for the
TC of physician pathology services
furnished to its inpatients.
Therefore, in the CY 2000 PFS final
rule with comment period, we revised
§ 415.130(c) to state that for physician
pathology services furnished on or after
January 1, 2001 by an independent
laboratory, payment is made only to the
hospital for the TC of physician
pathology services furnished to a
hospital inpatient. Ordinarily, the
provisions in the PFS final rule with
comment period are implemented in the
following year. However, the change to
§ 415.130 was delayed 1-year (until
January 1, 2001), at the request of the
industry, to allow independent
laboratories and hospitals sufficient
time to negotiate arrangements.
Full implementation of § 415.130 was
further delayed by section 542 of BIPA
and section 732 of the MMA, which
directed us to continue payment to
independent laboratories for the TC of
physician pathology services for
hospital patients for a 2-year period
beginning on January 1, 2001 and for
CYs 2005 and 2006, respectively. In the
CY 2007 PFS final rule with comment
period (71 FR 69788), we amended
§ 415.130 to provide that, for services
furnished after December 31, 2006, an
independent laboratory may not bill the
carrier for the TC of physician pathology
services furnished to a hospital
inpatient or outpatient. However,
section 104 of the MIEA–TRHCA
continued payment to independent
laboratories for the TC of physician
pathology services for hospital patients
through CY 2007, and section 104 of the
MMSEA further extended such payment
through the first 6 months of CY 2008.
Section 136 of the MIPPA extended
the payment through CY 2009. Section
3104 of the Affordable Care Act
amended the prior legislation to extend
the payment through CY 2010.
Subsequent to publication of the CY
2011 PFS final rule with comment
period, section 105 of the MMEA
extended the payment through CY 2011.
A. Section 105: Extension of Payment
for Technical Component of Certain
Physician Pathology Services
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1. Background and Statutory Authority
Section 542(c) of the Medicare,
Medicaid, and SCHIP Benefits
Improvement and Protection Act of
2000 (BIPA) (Pub. L. 106–554), as
amended by section 732 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173), section 104 of division B of
the Tax Relief and Health Care Act of
2006 (MIEA–TRHCA) (Pub. L. 109–432),
section 104 of the Medicare, Medicaid,
and SCHIP Extension Act of 2007
(MMSEA) (Pub. L. 110–173), section 136
of the Medicare Improvements for
Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110–275) and section
3104 of the Affordable Care Act (Pub. L.
111–148), as amended by section 105 of
the Medicare and Medicaid Extenders
Act of 2010 (MMEA) (Pub. L. 111–309),
continued payment to independent
laboratories for the technical component
(TC) of physician pathology services for
fee-for-service Medicare beneficiaries
who are inpatients or outpatients of a
covered hospital through CY 2011. The
TC of physician pathology services
refers to the preparation of the slide
involving tissue or cells that a
pathologist interprets. The professional
component (PC) of physician pathology
services refers to the pathologist’s
interpretation of the slide.
When the hospital pathologist
furnishes the PC service for a hospital
patient, the PC service is separately
billable by the pathologist. When an
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as if the various legislative changes to
the CFs for those years had not
occurred. Accordingly, under current
law, the anesthesia CF in effect in CY
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2. Revisions to Payment for TC of
Certain Physician Pathology Services
Consistent with this statutory change,
we proposed to revise § 415.130(d) to
specify that for services furnished after
December 31, 2011, an independent
laboratory may not bill the Medicare
contractor for the TC of physician
pathology services furnished to a
hospital inpatient or outpatient. We
would implement this provision
effective for TC services furnished on or
after January 1, 2012.
We received the following comments.
Comment: Several commenters
indicated that it was unclear whether
the TC payment is included in either the
inpatient prospective payment rate or in
the outpatient prospective payment
system (OPPS) payment made to the
hospital for the service. One commenter
noted that there is no duplicate payment
for outpatients because the hospital
does not bill Medicare for the TC of
outpatient pathology services in cases
where the independent laboratory bills
Medicare.
Response: Payment for the costs of
furnishing the pathology service (but
not its interpretation) is already
included in the bundled inpatient stay
payment to the hospital. We continue to
believe that this payment provision
represents a duplicate payment for the
TC service: (1) To the hospital, through
the inpatient prospective payment rate,
when the patient is an inpatient; and (2)
to the independent laboratory that bills
the Medicare contractor, instead of the
hospital, for the TC service. We agree
that there generally is no duplicate
payment for outpatient services because
the hospital does not bill Medicare
when the independent laboratory bills
Medicare.
Comment: Commenters indicated that
the proposal will shift costs to hospitals
without any comparable change in
reimbursement, resulting in
administrative, financial, and
operational hardships for both
independent laboratories and hospitals.
Under direct billing, laboratories submit
a single bill to Medicare for both the
TCs and the PCs. Without direct billing,
laboratories will have to issue two bills,
that is, one to Medicare for the PC and
another to the hospitals for the TC,
doubling their billing costs. Hospitals
will incur additional costs of creating
new billing systems. Such burdens will
fall most heavily on small, rural, and
critical access hospitals which often rely
on independent labs for surgical
pathology services. Some hospitals may
choose not to provide surgical pathology
services, thereby limiting access to care.
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Response: We believe that the
Medicare savings, resulting from the
elimination of duplicate payments,
offset the disadvantages to hospitals and
laboratories of any additional
administrative burden to implement the
provision. Medicare payment under the
IPPS encompasses almost all services
provided to the hospital inpatient
during their admission. We do not
believe it would be a substantial burden
to hospitals to bill for services provided
by independent laboratories because
this is how they bill for all other
laboratory services provided to hospital
inpatients. Further, hospitals and
independent laboratories have had
ample time to address modifications to
billing systems.
Comment: A commenter noted that a
demonstration project, mandated by the
Affordable Care Act would allow
laboratories to bill Medicare directly for
a complex diagnostic test which is
ordered by the patient’s physician less
than 14-days following the date of the
patient’s discharge from the hospital or
critical access hospital. The
demonstration will assess the impact of
this billing process on access to care,
quality of care, health outcomes, and
expenditures. The commenter requested
that we delay implementation of the
provision until the demonstration
project is complete.
Response: Section 3113 of the
Affordable Care Act requires the
Secretary to conduct a demonstration
project under Part B of title XVIII of the
Act under which separate payments are
made for certain complex diagnostic
laboratory tests. The demonstration
project is independent of our proposal
and involves a limited number of
pathology services, none of which are s
paid under the PFS. We continue to
believe that Medicare currently makes a
duplicate payment for such services and
we will not delay implementation of
this provision until the demonstration
project is complete.
After consideration of all public
comments, we are finalizing our
proposal without modification. Absent
additional legislation, for services
furnished after December 31, 2011, an
independent laboratory may not bill a
Medicare contractor for the TC of
physician pathology services for fee-for
service Medicare beneficiaries who are
inpatients or outpatients of a covered
hospital. Accordingly, we are finalizing
the proposed revisions to
§ 415.130(d)(1) and (2) to reflect this
change.
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73279
B. Bundling of Payments for Services
Provided to Outpatients Who Later Are
Admitted as Inpatients: 3-Day Payment
Window Policy and the Impact on
Wholly Owned or Wholly Operated
Physician Practices
1. Introduction
On June 25, 2010, the Preservation of
Access to Care for Medicare
Beneficiaries and Pension Relief Act of
2010 (PACMBPRA) (Pub. L. 111–192)
was enacted. Section 102 of this Act
entitled, ‘‘Clarification of 3-Day
Payment Window,’’ clarified when
certain services furnished to Medicare
beneficiaries in the 3-days (or, in the
case of a hospital that is not a
subsection (d) hospital, during the 1day) preceding an inpatient admission
should be considered ‘‘operating costs
of inpatient hospital services’’ and
therefore included in the hospital’s
payment under the Hospital Inpatient
Prospective Payment System (IPPS).
This policy is generally known as the
‘‘3-day payment window.’’ Under the 3day payment window, a hospital (or an
entity that is wholly owned or wholly
operated by the hospital) must include
on the claim for a Medicare
beneficiary’s inpatient stay, the
technical portion of any outpatient
diagnostic services and nondiagnostic
services related to the admission
provided during the payment window.
The new law makes the policy
pertaining to admission-related
nondiagnostic services more consistent
with common hospital billing practices.
Section 102 of the PACMBPRA is
effective for services furnished on or
after June 25, 2010.
2. Background
We discussed changes to the 3-day
payment window policy in the interim
final rule with comment period that was
issued as part of last year’s IPPS final
rule (75 FR 50346). The PACMBPRA
made no changes to the billing of
‘‘diagnostic services’’ furnished during
the 3-day payment window, which are
included in the ‘‘operating costs of
inpatient hospital services’’ pursuant to
section 1886(a)(4) of the Act. All
diagnostic services furnished to a
Medicare beneficiary by a hospital (or
an entity wholly owned or wholly
operated by the hospital), on the date of
a beneficiary’s admission or during the
3-days (1-day for a non-subsection (d)
hospital) immediately preceding the
date of a beneficiary’s inpatient hospital
admission, continue to be included on
the Part A bill for the beneficiary’s
inpatient stay at the hospital. In
accordance with section 102(a)(1) of the
PACMBPRA, for outpatient services
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furnished on or after June 25, 2010, all
nondiagnostic services, other than
ambulance and maintenance renal
dialysis services, provided by the
hospital (or an entity wholly owned or
wholly operated by the hospital) on the
date of a beneficiary’s inpatient
admission and during the 3 calendar
days (1 calendar day for a
nonsubsection (d) hospital) immediately
preceding the date of admission are
deemed related to the admission and,
therefore, must be billed with the
inpatient stay, unless the hospital attests
that certain nondiagnostic services are
unrelated to the hospital claim (that is,
the preadmission nondiagnostic services
are clinically distinct or independent
from the reason for the beneficiary’s
inpatient admission). In such cases, the
unrelated outpatient hospital
nondiagnostic services are covered by
Medicare Part B, and the hospital may
separately bill for those services.
Prior to the enactment of the 3-day
payment window clarification under
section 102 of the PACMBPRA, the term
‘‘related to the admission’’ was defined
in section 40.3, Chapter 3, Inpatient
Hospital Billing, of the Medicare Claims
Processing Manual (Pub. 100–04) to
mean an exact match between the
principal ICD–9 CM diagnosis codes for
the outpatient encounter and the
inpatient admission. On November 5,
1990, section 4003(a) of the Omnibus
Budget Reconciliation Act of 1990 (Pub.
L. 101–508) amended the statutory
definition of ‘‘operating cost of inpatient
hospital services’’ in section 1886(a)(4)
of the Act to include the costs of certain
services furnished prior to admission.
Section 4003(a) also required that these
preadmission services be included on
the Medicare Part A bill for the
subsequent inpatient stay. With this
amendment, section 1886(a)(4) of the
Act defines the operating costs of
inpatient hospital services to include
diagnostic services (including clinical
diagnostic laboratory tests) or other
services related to the admission (as
defined by the Secretary) that are
furnished by the hospital (or by an
entity that is wholly owned or wholly
operated by the hospital) to the patient
during the 3-days prior to the date of the
patient’s admission to the hospital.
Section 1886(a)(4) of the Act was
further amended by section 110 of the
Social Security Amendments of 1994
(Pub. L. 103–432) enacted on October
31, 1994. This provision revised the
payment window for hospitals that are
excluded from the IPPS to include only
those services furnished by the hospital
or an entity wholly owned or wholly
operated by the hospital during the 1day (instead of the previous 3-days)
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prior to the patient’s hospital inpatient
admission. The hospital and hospital
units excluded from the IPPS and
affected by this policy are psychiatric
hospitals and units, inpatient
rehabilitation hospitals and units, longterm care hospitals, children’s hospitals,
and cancer hospitals. In the FY 1996
IPPS final rule (60 FR 45840), we noted
that the term ‘‘day,’’ as referenced in the
3-day or 1-day payment window policy
refers to the entire calendar day
immediately preceding the date of
admission and not the 24-hour time
period that immediately precedes the
hour of admission.
On February 11, 1998, we published
a final rule (63 FR 6864), that responded
to public comments received on a prior
interim final rule on this policy. In that
final rule, we confirmed that ambulance
services and chronic maintenance of
renal dialysis services are excluded
from the 3-day payment window. This
final rule with comment period also
clarified that the payment window
applies to outpatient services that are
otherwise billable under Part B and does
not apply to nonhospital services that
are generally covered under Part A
(such as home health, skilled nursing
facility, and hospice). In addition the
rule clarified the terms ‘‘wholly owned
or operated’’ and ‘‘admission-related’’
for nondiagnostic services.
The 1998 final rule (63 FR 6866)
defined an entity as wholly owned or
wholly operated if a hospital has direct
ownership or control over another
entity’s operations. Specifically, 42 CFR
412.2(c)(5)(i) states, ‘‘An entity is
wholly owned by the hospital if the
hospital is the sole owner of the entity.
An entity is wholly operated by a
hospital if the hospital has exclusive
responsibility for conducting and
overseeing the entity’s routine
operations, regardless of whether the
hospital also has policymaking
authority over the entity.’’ The 1998
final rule also stated ‘‘that we have
defined services as being related to the
admission only when there is an exact
match between the ICD–9–CM diagnosis
code assigned for both the preadmission
services and the inpatient stay’’ and that
‘‘[a]’’ hospital-owned or hospitaloperated physician clinic or practice is
subject to the payment window
provision.’’ Therefore, related
preadmission nondiagnostic services
provided by a wholly owned or wholly
operated physician clinic or practice are
also included in the 3-day (or 1-day)
payment window policy, and services
were considered related when there was
an exact match between ICD–9 CM
diagnosis codes for the outpatient
encounter and the inpatient admission.
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Prior to the June 25, 2010 enactment
of section 102(a)(1) of PACMBPRA (Pub.
L. 111–192), the payment window
policy for preadmission nondiagnostic
services was rarely applied in the
wholly owned or operated physician’s
office or clinic because, as we
previously noted, the policy required an
exact match between the principal ICD–
9 CM diagnosis codes for the outpatient
services and the inpatient admission.
Because of the exact match policy, very
few services furnished in a physician’s
office or clinic that is wholly owned or
operated by the hospital would be
subject to the policy. Because the policy
applied only in such narrow
circumstances, until the recent statutory
change, we have not provided further
guidance to wholly owned or wholly
operated physician offices on how
nondiagnostic services are to be
included on hospital bills when the 3day payment window applied.
However, the statutory change to the
payment window policy made by Pub.
L. 111–192 significantly broadened the
definition of nondiagnostic services that
are subject to the payment window to
include any nondiagnostic service that
is clinically related to the reason for a
patient’s inpatient admission, regardless
of whether the inpatient and outpatient
diagnoses are the same.
The FY 2012 IPPS proposed (76 FR
25960) and final rules (76 FR 51705)
further discuss the application of the 3day payment window for both
preadmission diagnostic and related
nondiagnostic services furnished to a
patient at wholly owned or wholly
operated physician practices after June
25, 2010. We do not know how many
physician offices are wholly owned or
wholly operated. Our expectation is that
most hospital-owned entities providing
outpatient services would be considered
part of the hospital, likely as an
outpatient department, and not as
separate physician clinics or practices
or other entities such as clinical
laboratories. However, we believe there
may be at least some hospital clinics
that meet the definition of a wholly
owned or wholly operated physician
practice. When a physician furnishes a
service in a hospital, including an
outpatient department of a hospital,
Medicare pays the physician under the
physician fee schedule, generally at a
facility-based payment rate that is lower
than the ‘‘nonfacility’’ payment rate in
order to avoid duplication of payment
for supplies, equipment, and staff that
are paid directly to the hospital by
Medicare.
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3. Applicability of the 3-Day Payment
Window Policy for Services Furnished
in Physician Practices
In circumstances where the 3-day
payment window applies to
nondiagnostic services related to an
inpatient admission furnished in a
wholly owned or wholly operated
physician practice, we proposed that
Medicare would make payment under
the physician fee schedule for the
physicians’ services that are subject to
the 3-day payment window at the
facility rate. As explained more fully
later in this section, the services that are
subject to the 3-day payment window
would be billed to Medicare in a similar
manner to services that are furnished in
a hospital, including an outpatient
department of a hospital. We proposed
that, effective on or after January 1,
2012, when a physician furnishes
services to a beneficiary in a hospital’s
wholly owned or wholly operated
physician practice and the beneficiary is
admitted as an inpatient within 3 days
(or, in the case of non-IPPS hospitals, 1
day), the payment window will apply to
all diagnostic services furnished and to
any nondiagnostic services that are
clinically related to the reason for the
patient’s inpatient admission regardless
of whether the reported inpatient and
outpatient diagnosis codes are the same.
Comment: A few commenters
expressed concern over the proposed
phrase of ‘‘physician clinics or
practices,’’ suggesting that CMS
proposed to define the application of
this provision too narrowly because the
statutory provision on the 3-day
payment window refers to ‘‘entity’’ and
not specifically to physician clinics or
practices. Another commenter suggested
the phrase ‘‘Free-standing facility or
clinic’’ to be more appropriate for the 3day window payment policy, and refers
CMS to the definition of ‘‘Free-standing
facility’’ set forth in 42 CFR 413.65(a)(2).
Response: We appreciate commenters’
attention to the discrepancy between the
proposed term ‘‘physician clinics or
practices’’ and the statutory reference to
‘‘entity,’’ and we agree that Public Law
111–192 applies the 3-day payment
window policy to services related to the
admission including all diagnostic
services and clinically related services
that are not diagnostic services, other
than ambulance and maintenance renal
dialysis services, for which payment
may be made under Medicare Part B and
that are provided by a hospital (or an
entity wholly owned or operated by the
hospital) to a patient. We agree with
commenters that the statute does not
limit this provision solely to physician
offices or clinics. The term ‘‘entity’’
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applies to Part B entities that provide
diagnostic or related nondiagnostic
services which would include a host of
entities including clinical laboratory
facilities and ambulatory surgical
centers, and any other entity providing
Part B outpatient services. If these
entities are wholly owned or wholly
operated by a hospital per the
definitions set forth in the 1998 IPPS
final rule (63 FR 6866), the 3-day
payment window would apply to the
preadmission diagnostic and
nondiagnostic services provided by
those entities when those preadmission
services are clinically related to a
patients inpatient admission within the
payment window. We will amend our
proposed regulation text defining
facility practice expense RVUs to use
the term ‘‘entity’’ in § 414.22(b)(5)(1)(A)
instead of ‘‘physician practice’’ as
proposed ‘‘(A) the facility PE RVUs
apply to services furnished to patients
in the hospital, skilled nursing facility,
mental health center, ambulatory
surgical center, or in a wholly owned or
wholly operated entity furnishing
preadmission services pursuant to
§ 412.2(c)(5).’’
The principal focus of our CY 2012
proposed rule and our discussion in the
IPPS FY 2012 final rule with comment
period was on physician offices and
clinics. We are concerned that hospitals
may not realize that some of the services
provided by wholly owned or wholly
operated entities that might furnish
preadmission services, other than
physician practices and clinics, such as
ambulatory surgical centers, are subject
to the payment window. The purpose of
this discussion in the CY 2012 PFS
proposed rule was to address how a
wholly owned or wholly operated
physician practice would bill for
professional and technical services
when provided within the 3-day
payment window. We believe that
physician practices are the majority of
wholly hospital owned or wholly
operated Part B entities providing
nondiagnostic services that are related
to an inpatient admission. We
previously addressed applicability of
the payment window policy to wholly
owned or wholly operated entities in
our 1998 final rule, and at that time
emphasized that diagnostic services are
always included in the 3-day payment
window (75 FR 6866). In this final rule
with comment period, we are
addressing the policy’s application to
entities that are wholly owned or
wholly operated physician practices and
clinics, and we note that wholly owned
or wholly operated entities providing
diagnostic services always have been
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73281
subject to the payment window. We
encourage hospitals to bring any other
wholly owned or wholly operated Part
B entities into compliance with the 3day payment window policy as
discussed in this final rule. If needed,
we will address specifics related to
other Part B entities in future
rulemaking.
Although rural health clinics (RHCs)
and Federally qualified health centers
(FQHCs) would be considered
‘‘entities,’’ we are not applying the 3day payment window policy to these
entities. Medicare pays RHCs and
FQHCs for their services through an allinclusive rate that incorporates payment
for all covered items and services
provided to a beneficiary on a single day
by an RHC/FQHC physician, physician
assistant, nurse practitioner, clinical
nurse midwife, clinical psychologist,
clinical social worker, or visiting nurse;
and related services and supplies
(Publication 100–04 (Medicare Claims
Processing Manual), chapter 19, section
20.1). RHCs and FQHCs can only bill
and be paid for services included in
their all-inclusive rate. Although the
majority of those services are
professional services, it is impossible to
distinguish within the all-inclusive rate
the amount of the payment for any
particular patient that represents the
professional versus the technical
portion. As previously discussed, the 3day payment window policy requires a
hospital to include in its bill for an
inpatient admission the technical
portion of any outpatient diagnostic
services and admission-related
nondiagnostic services provided during
the preadmission payment window.
Professional services are not considered
to be operating costs of inpatient
hospital services and, accordingly, are
not subject to the 3-day payment
window policy. Given that the 3-day
payment window policy does not
include professional services, and that
RHCs and FQHCs are paid an allinclusive rate within which the
professional and technical portions are
indeterminate, we do not consider RHC
or FQHC services to be subject to the 3day payment window policy. However,
if in the future RHCs or FQHCs are no
longer paid an all-inclusive rate, but
rather, under a prospective or other
payment system that allows distinction
between the PC and TC for services, the
3-day payment policy would apply in
these settings In addition the list of
covered services paid through the RHC
and FQHC benefits is relatively small.
Practitioners who furnish additional
services in RHCs or FQHCs bill
Medicare Part B for any additional
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services provided to a Medicare
beneficiary during an RHC or FQHC
visit. Any such additional services
would not be considered RHC or FQHC
services, but rather, would be
considered the practitioner’s services. If
a patient is admitted as an inpatient, the
additional services payable under Part B
are subject to the 3-day payment
window. With regard to the comment
suggesting that we adopt the definition
of ‘‘free-standing facility’’ in lieu of the
term wholly owned or wholly operated
entity, we believe the reference under
section 1886(a)(4) of the Act to ‘‘an
entity wholly owned or operated by the
hospital’’ was intended to identify
entities that have a significant degree of
integration with the hospital but, for
whatever reason, are not considered
provider-based. As such, we do not
believe it would be appropriate ‘‘to use
the term ‘‘free-standing facility’’ to
describe wholly owned or wholly
operated entities. As defined in § 412.2
(c)(5)(i), an entity is considered wholly
owned or wholly operated by the
hospital, and preadmission services
furnished by the entity are subject to 3day payment window policy, if the
hospital is the sole owner of the entity
or if the hospital has exclusive
responsibility for conducting and
overseeing the entity’s routine
operations, regardless of whether the
hospital also has policymaking
authority ‘‘over the entity.’’ We continue
to believe that this is the appropriate
description of entity wholly owned or
operated by the hospital.
Comment: Several commenters
requested that CMS distinguish wholly
owned and wholly operated physician
practices from ‘‘provider based’’
physician practices and confirm that the
proposed 3-day window payment policy
makes no change in how provider-based
physician practices currently bill
Medicare for physician and nonphysician practitioner services.
Response: As described previously,
we believe the statutory reference in
section 1886(a)(4) to an entity wholly
owned or wholly operated by the
hospital was not intended to identify
provider-based entities. Rather, we
believe the language was intended to
identify entities that have a significant
degree of integration with the hospital
but, for whatever reason, are not
considered to have provider-based
status. As previously discussed, a
hospital must include on the hospital
claim for a Medicare beneficiary’s
inpatient stay, the technical portion of
any outpatient diagnostic services and
admission-related nondiagnostic
services provided by the hospital, or by
an entity that is wholly owned or
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wholly operated by the hospital, during
the payment window. Entities with
provider-based status are considered to
be part of the hospital and the hospital
should already be including costs of
related outpatient services provided
within the 3-day payment window on
the claim for the inpatient admission.
We agree with the commenters that the
proposed 3-day window payment
policy, adopted in this final rule with
comment period, makes no change in
how provider-based physician practices
currently bill Medicare for the
professional work of physician and nonphysician practitioner services Those
services are not subject to the 3-day
payment window policy.
Comment: A number of commenters
wanted CMS to further define
admission-related nondiagnostic
services. Some commenters encouraged
CMS to return to the definition of
admission-related that requires an exact
match on the ICD–9–CM diagnosis
codes for the inpatient and outpatient
claims. They suggested that if an exact
match is no longer an appropriate
definition of nondiagnostic admissionrelated, CMS should develop some
equally clear and easy standard. Some
commenters went on to suggest that
CMS identify all the nondiagnostic
services that should be considered
‘‘clinically related’’ to an inpatient
admission and subject to the 3-day
payment window payment policy.
Response: We have stated that ‘‘an
outpatient service is related to the
admission if it is clinically associated
with the reason for a patient’s inpatient
admission’’ (75 FR 50347). We believe
that determining whether an outpatient
service is ‘‘clinically related’’ requires
knowledge of the specific clinical
circumstances surrounding a patient’s
inpatient admission and can only be
determined on a case by case basis. In
the August 16, 2010 interim final rule
with comment period (75 FR 50348), we
indicated that we would develop a
process for hospitals to attest on the
outpatient hospital claim that
nondiagnostic services are not clinically
related to the admission when the
hospital believes that certain provided
outpatient services are unrelated. We
discuss that mechanism for hospital
billing of unrelated nondiagnostic
services in the FY 2012 final rule (76 FR
51708). We also indicated that a
hospital would be required to maintain
documentation in the beneficiary’s
medical record to support their claim
that the outpatient nondiagnostic
services are unrelated to the
beneficiary’s inpatient admission.
Because the 3-day payment window
applies equally to services provided by
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the hospital or the hospital’s wholly
owned or wholly operated entities, we
would expect hospitals to make the
same determination and documentation
for services provided by wholly owned
or wholly operated entities. Therefore,
we expect hospitals and their wholly
owned and wholly operated entities to
ascertain whether nondiagnostic
services provided in the 3-day payment
window are clinically related to the
subsequent inpatient admission given
the context of the patient’s unique
clinical circumstances. If the
nondiagnostic services are related, we
expect the wholly owned or wholly
operated entity to use the appropriate
payment modifier, discussed in greater
detail under section V.B.3.a of this final
rule with comment period, to indicate
that services are clinically related to the
subsequent inpatient admission. If the
nondiagnostic services are not clinically
related, we would expect the hospital or
wholly owned or wholly operated entity
to document the reason those services
are not clinically related in the
beneficiary’s medical record, and we
would expect the wholly owned or
wholly operated entity to receive the
full nonfacility payment for provided
services. We note that all diagnostic
services provided in the 3-day payment
window prior to an inpatient admission
are subject to the 3-day payment
window policy.
a. Payment Methodology
In the proposed rule, we indicated
that we would establish a new Medicare
HCPCS modifier that will signal claims
processing systems to provide payment
to wholly owned or wholly operated
entities at the facility rate. We proposed
to pay only the Professional Component
(PC) for CPT/HCPCS codes with a
Technical Component (TC)/PC split that
are provided in the 3-day (or, in the case
of non-IPPS hospitals, 1-day) payment
window in a hospital’s wholly owned or
wholly operated physician practice. We
proposed to pay at the facility rate for
codes without a TC/PC split to avoid
duplicate payment for the technical
resources required to provide the
preadmission services as those costs
will be included on the hospital’s
inpatient claim for the related inpatient
admission. The facility rate includes
physician work, malpractice, and the
facility practice expense, which is a
payment to support services provided
by the physician office when a
physician treats patients at another
facility. We proposed to modify our
regulation at § 414.22(b)(5)(i), which
defines the sites of service that result in
a facility practice expense RVU for
payment, to add an entity that is wholly
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owned or wholly operated by a hospital,
as defined in § 412.2(c)(5)(ii) when that
entity furnishes preadmission services.
We indicated in the proposed rule
that we would establish a new HCPCS
modifier through sub-regulatory
guidance. We said that we would
require that this modifier be appended
to the physician preadmission
diagnostic and admission-related
nondiagnostic services, reported with
HCPCS codes, which are subject to the
3-day payment window policy. We
stated that each wholly owned or
wholly operated physician’s practice
would need to manage its billing
processes to ensure that it billed for its
physician services appropriately when a
related inpatient admission has
occurred.
We stated that the hospital will be
responsible for notifying the practice of
related inpatient admissions for a
patient who received services in a
wholly owned or wholly operated
physician practice within the 3-day (or,
when appropriate, 1-day) payment
window prior to the inpatient stay. We
proposed to make the new modifier
effective for claims with dates of service
on or after January 1, 2012, and we
proposed that wholly owned or wholly
operated physician practices would
receive payment at the facility rate for
related nondiagnostic services and
receive payment for only the
professional component for diagnostic
services effective for services furnished
on or after January 1, 2012.
Comment: Many commenters
expressed concern that CMS has ‘‘erred
in their assumptions’’ that the costs of
preadmission services provided in
entities wholly owned or wholly
operated by a hospital are ‘‘costs of the
hospital.’’ A few commenters suggested
that it would be unlikely that outpatient
visits furnished in a wholly owned or
wholly operated entity would be
documented in the medical record or
captured in the hospital’s accounting
system before the inpatient admission
and therefore, would not be properly
included on the hospital’s cost report.
These commenters requested that CMS
provide specific instructions on how
hospitals should include the technical
component costs of the physician office
visit on hospital cost reports. Finally, a
few commenters requested clarification
on whether the facility cost involved
with services furnished at a wholly
owned or wholly operated entity are
taken into account in determining
prospective hospital inpatient payment
under the IPPS. Another commenter
asserted that even if the hospital
includes charges for the wholly owned
or wholly operated entity on the
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hospital’s inpatient claim, the hospital’s
inpatient payment will not reflect this
change until the costs are reflected in
historical data used to calculate the
prospective inpatient payment rates.
Response: We expect hospitals to
include the technical component
portion of all diagnostic and clinically
related nondiagnostic services furnished
by wholly owned or wholly operated
entities in the 3-day payment window
on their cost report. Hospitals should
accumulate the costs incurred and the
adjustments required for these services
and report as costs with related
organizations on the Medicare cost
report. The costs for these services
should be reported on the Medicare cost
report as routine and/or ancillary
accordingly, to achieve a proper
matching of revenues and expenses.
Each year, the IPPS uses the most recent
full year of cost report data available to
establish the relative cost-based weights.
For example, for the FY 2012 IPPS
update, we used data from cost reports
that began during FY 2009, that is, on
or after October 1, 2008 and before
October 1, 2009, in computing the
relative weights.
We expect that the cost of diagnostic
and related nondiagnostic services that
are provided in wholly owned or wholly
operated entities during the 3-day
payment window will be included in
the data used to determine future IPPS
relative payment weights. This cycle of
having costs and charges reflected in the
payment rates for future years is part of
the longstanding methodology behind
setting hospital prospective payment
rates. Hospitals should already be
including the costs of diagnostic
services furnished by wholly owned or
wholly operated entities on their cost
report because the 3-day payment
window policy for diagnostic services is
longstanding. Furthermore, we note that
the inclusion of charges for diagnostic
and related nondiagnostic services that
are provided in wholly hospital owned
or wholly operated entities during the
3-day payment window on an inpatient
claim could increase the probability that
the claim for the inpatient admission
would garner outlier payments.
Comment: Many commenters
requested that CMS delay
implementation a full year so that
hospitals and wholly owned or wholly
operated entities may appropriately
develop internal claims processing
procedures to ensure hospital/entity
coordination when billing services
subject to the payment window. Many
commenters objected to CMS’s proposal
to allow each wholly owned or wholly
operated physician practice to manage
its billing practices and requested
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73283
additional guidance from CMS to ensure
that they bill appropriately and for
requiring that the hospital be
responsible for notifying the physician
practice of an inpatient admission.
Several commenters noted that
physician practices may use
independent software systems for
patient registration, scheduling, billing,
and accounting and went on to stress
that the coordination efforts to ensure
appropriate billing will be a substantial
burden on both the hospital and the
physician practice and that CMS is
essentially asking practices to hold
claims for all Medicare encounters at
least 7 to 10 days after every office
service is rendered.
Response: We appreciate commenters
concerns for implementation and
understand that each wholly owned or
operated entity will face unique
operational challenges as they
incorporate the 3-day payment window
policy into billing practices. While we
understand that some entities may need
to hold claims for a longer time period
to comply with the policy, we note that
the 3-day payment window policy is a
hospital requirement. We believe that
hospitals can assist their wholly owned
or wholly operated entities in managing
the unique aspects of billing for services
subject to the payment window policy.
In light of the consistent message from
commenters that the billing and
accounting systems are not yet
coordinated, we are concerned that
many hospitals and their wholly owned
or wholly operated entities will not be
able to establish the internal procedures
and communication pathways needed to
comply with the law by January 1, 2012.
For this reason we will delay
implementation until July 1, 2012.
Beginning on January 1, 2012, CMS
payment modifier PD (Diagnostic or
related nondiagnostic item or service
provided in a wholly owned or wholly
operated entity to a patient who is
admitted as an inpatient within 3 days,
or 1 day) will be available, and wholly
owned or wholly operated entities
should begin to append the modifier to
claims subject to the 3-day payment
window at that time. We expect that
hospitals and their wholly owned or
wholly operated entities will continue
working toward establishing internal
processes to ensure compliance with
section 102 of PACMBPRA as quickly as
possible to achieve coordinated billing
for services subject to the 3-day
payment window policy. We will
require hospitals and their wholly
owned or wholly operated entities to
fully coordinate their billing and to
properly bill for diagnostic and related
nondiagnostic services subject to the
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3-day payment window policy
beginning July 1, 2012. We encourage
hospitals to adjust their internal
processes as quickly as possible to
ensure a smooth implementation.
With regard to the comment that the
hospital should not need to notify its
wholly owned or wholly operated
entities, we note that the 3-day payment
policy implemented on October 1, 1991,
is an existing statutory requirement
located in the statutory definition of
hospital operating costs, and that the
purpose of this final rule is to clarify the
implementation of the policy when a
entity that is wholly owned or wholly
operated by a hospital furnishes
preadmission diagnostic and related
nondiagnostic services to a patient who
is later admitted as an inpatient within
the payment window. In the FY 2012
IPPS final rule we responded to a
comment on this topic, stating that
because the hospital owns the facility, it
is our expectation that the hospital will
be able to coordinate and track the
patient activity of the facilities it owns.
The full adoption of electronic medical
record should help facilitate
coordination and tracking of patients
within and among hospital systems (76
FR 51709).
Comment: One commenter asked if
the ‘‘minimally necessary’’ privacy
standard required by Health Insurance
Portability and Accountability Act
(HIPAA) would be met if hospital
registration staff could access the
patient database at a physician’s office.
Response: We believe that neither
hospital nor entity staff would violate a
patient’s privacy by notifying each other
about admissions or furnished services
for purposes of coordinating billing
under the 3-day payment window
policy. Wholly owned or wholly
operated entities can exchange this
information for billing purposes. The
HIPAA regulations at 45 CFR §§ 164.502
and 164.506 allow a covered entity to
use or disclose protected health
information for ‘‘treatment, payment, or
health care operations.’’ HIPAA covered
entities should be able to carry out these
requirements in accordance with those
provisions.
Comment: A few commenters
expressed concern that if a hospital fails
to notify the wholly owned or operated
practice of an inpatient admission, and
if the practice submits the claim to
Medicare without the appropriate
modifier, the practice risks an
overpayment or charges of filing a false
claim.
Response: We expect hospitals and
wholly owned or operated entities to
ensure that claims submitted to
Medicare for payment are in compliance
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with Medicare policy. We are delaying
our proposed implementation from
January 1, 2012 to July 1, 2012 to give
hospitals and their wholly owned or
wholly operated entities sufficient time
to develop a compliant billing system
and to develop a coordinated billing
practice to ensure correct use of the new
payment modifier. We would expect
entities that find they have billed in
error to submit a replacement claim, but
we would expect this to be a rare
occurrence.
Comment: A few commenters
inquired about physicians billing for
subordinate personnel under an
‘‘incident to’’ arrangement for purposes
of the 3-day payment window policy in
the nonfacility setting. Commenters also
asked if drug and biological therapies
were considered services subject to the
payment window policy, and a few
commenters specifically asked if CMS
will deny Medicare payments for the TC
for any diagnostic imaging or diagnostic
testing provided within the 3-days of a
hospital admission.
Response: The 3-day payment
window makes no change to how an
entity bills for physician services in the
nonfacility setting. If, for example, an
admitted hospital inpatient received
services at a wholly owned or wholly
operated entity prior to his admission,
and some of those services were
delivered by a nurse incident to the
physician’s service, the physician
would still bill for those services under
the 3-day payment window policy. The
3-day payment window applies to all
diagnostic and related nondiagnostic
services provided within the window,
including drug therapies and imaging
services, assuming those services are
related to the inpatient admission.
We realize that the time frames
associated with the global surgical
package for many surgical services
could overlap with the 3-day (or 1-day)
payment window policy. Global surgical
payment rules apply to major and minor
surgeries, and endoscopies. Section 40.1
of the Claims Processing Manual (100–
04 chapter 12 Physician/Nonphysician
Practitioners) defines the global surgical
package. Procedures can have a global
surgical period of 0, 10, or 90-days.
Generally, the global period for major
surgeries is 1 day prior to the surgical
procedure and 90 days immediately
following the procedure. For minor
surgeries, the global period is the day of
the procedure and 10 days immediately
following the procedure.
Medicare payment for the global
surgical package is based on the typical
case for a procedure, and includes
preoperative visits, intra-operative
services, and complications following
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surgery, postoperative visits,
postsurgical pain management,
supplies, and miscellaneous other
services such as dressing changes and
removal of sutures or staples. Medicare
makes a single payment to the treating
physician (or group practice) for the
surgical procedure and any of the preand post-operative services typically
associated with the surgical procedure
provided within the global surgical
period (10 or 90-days). The same section
of the Claims Processing Manual (100–
04 chapter 12 Physician/Nonphysician
Practitioners) also discusses the services
that are not included in payment for the
global surgical period. In general, these
services are unrelated to the surgery, are
diagnostic or are part of the decision to
pursue surgery, or are related to the
surgery but are so significant they
warrant an additional payment. Some
examples of services not included in
payment for the global surgical period
include the initial evaluation of the
problem by the surgeon to determine the
need for major surgery; services of
another physician; visits unrelated to
the diagnosis for the surgical procedure
unless the visits occur due to surgical
complications; treatment that is not part
of the normal recovery from surgery;
diagnostic tests; distinct surgical
procedures that are not re-operations;
treatment for postoperative
complications that require a return trip
to the operating room; critical care
unrelated to the surgery where a
seriously injured or burned patient is
critically ill and requires the constant
attention of the physician; and
immunosuppressive therapy for organ
transplants.
The time frames for application of the
3-day payment window and the global
surgical package could overlap. In some
cases, the application of the 3-day
payment window is straightforward. For
example, a patient could have minor
surgery in a wholly owned or wholly
operated physician’s office and, due to
complications, need to be admitted
within 3-days to an acute care hospital
paid under the IPPS for follow-up
surgery. Under the 3-day payment
window policy, the practice expense
portion of the initial surgery and any
pre- and post-operative visits associated
with the surgery (both those subject to
the global surgery rules and separate
diagnostic procedures) should be
included on the hospital’s Part A claim
for the inpatient admission. The wholly
owned or wholly operated physician
practice would bill for the surgery
performed for the inpatient as well as
for the initial surgical procedure
performed in the physician practice that
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started the global period. The wholly
owned or wholly operated physician
practice would apply the HCPCS
modifier to indicate that the 3-day
payment window applies to each of
those services. Medicare would pay the
physician practice for the initial surgical
procedure and the related procedure
following inpatient admission at the
facility rate. Finally, any preadmission
diagnostic tests conducted by the
wholly owned or wholly operated
physician practice in the 3-day payment
window would be included on the
physician practice’s claim with the
HCPCS modifier, and Medicare would
pay the wholly owned or wholly
operated physician practice only the
professional portion of the service.
However, the situation could arise
where a global surgical period overlaps
with the 3-day payment window, but
the actual surgical procedure with the
global surgical package occurred before
the 3-day payment window. In this case,
several post-operative services, such as
follow-up visits, would occur during the
global period, but the surgeon would
not bill separately for those services. We
proposed that services with a global
surgical package would be subject to the
3-day payment window policy when
wholly owned or wholly operated
physician practices furnish
preadmission diagnostic and
nondiagnostic services that are
clinically related to an inpatient
admission when the date of the actual
surgical procedure falls within the 3-day
payment window policy. However,
when the actual surgical procedure for
a service that has a global surgical
package is furnished on a date that falls
outside the 3-day payment window, the
3-day window policy would not apply.
We do not believe it would be
appropriate to require the wholly owned
or wholly operated physician practice to
unbundle the post operative services
associated with the global surgical
procedure so that the practice expense
portion of those services could be paid
under the PFS at the facility rate and the
costs included on the hospital’s
inpatient claim. However, any service
that a wholly owned or wholly operated
physician practice would bill separately
from the global surgical package, such
as a separate initial evaluation of a
problem by the surgeon to determine the
need for surgery or separate diagnostic
tests, would continue to be subject to
the 3-day payment window policy.
We did not receive any comments on
our proposal to include diagnostic and
related nondiagnostic services with a
global surgical package in the 3-day
payment window when the date of the
surgical procedure falls within the 3 day
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payment window, and we are finalizing
our policy without modification.
b. Identification of Wholly Owned or
Wholly Operated Physician Practices
The 1998 final rule (63 FR 6864)
defined wholly owned or wholly
operated as a hospital’s direct
ownership or control over another
entity’s operations. In that rule, we
added the regulation at 42 CFR
412.2(c)(5)(i) which states, ‘‘An entity is
wholly owned by the hospital if the
hospital is the sole owner of the entity.
An entity is wholly operated by a
hospital if the hospital has exclusive
responsibility for conducting and
overseeing the entity’s routine
operations, regardless of whether the
hospital also has policymaking
authority over the entity.’’
Physician practices self-designate
whether they are owned or operated by
a hospital during the Medicare
enrollment process. Currently, a
physician practice enrolls in Medicare
with CMS form ‘‘855B.’’ This
enrollment form reports pertinent
practice information such as ownership,
organizational structure, and
operational duties. Likewise, hospitals
enroll in Medicare using CMS form
‘‘855A’’ also reporting pertinent hospital
information such as ownership,
organizational structure and operational
duties. Medicare Administrative
Contractors update files of physician
practices that are owned and operated
by hospitals, and the files of hospitals
that own those physician practices, in
their claims processing systems and use
that data to confirm an ownership
relationship for identified physician
practices. We will investigate the
feasibility of establishing national
system edits within the Common
Working File to fully identify whether a
physician practice is wholly owned or
wholly operated by a hospital and to
associate such practice with its affiliated
hospital.
Comment: Many commenters
requested further clarification of the
definition of ‘‘wholly owned or wholly
operated.’’ A few commenters
encouraged CMS to adopt the definition
of ‘‘wholly-owned’’ as the term is
described in 42 CFR 413.65(e)(1) which
states ‘‘The business enterprise is 100
percent owned by the main provider’’
while other commenters requested
examples of ownership interest and
requested that CMS display a list of
hospitals and their wholly owned or
wholly operated entities. Other
commenters encouraged CMS to modify
the definition of ‘‘wholly operated’’ to
provide more granularity than simply
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73285
stating ‘‘conducting and overseeing the
entity’s routine operations.’’
Response: While we appreciate
commenters’ suggestions on revising the
definition of wholly owned or wholly
operated, section 102 of the PACMBPRA
only clarified the scope of services
furnished to Medicare beneficiaries
within the 3-days (or, in the case of a
hospital that is not a subsection (d)
hospital, during the 1 day) preceding an
inpatient admission that should be
considered ‘‘operating costs of inpatient
hospital services’’ and, therefore,
included in the hospital’s inpatient
payment. In describing the scope of
services subject to the 3-day window
policy, section 102 did not change the
existing statutory reference to ‘‘an entity
wholly owned or operated by the
hospital.’’ We have had in place
longstanding definitions of these terms
and, therefore, we did not propose a
change to our longstanding definitions.
We continue to believe that our
longstanding definitions are consistent
with the statute and appropriately
descriptive for this purpose. Therefore,
we will retain our current definitions.
The 3-day payment window policy
has been applicable for all preadmission
diagnostic and related nondiagnostic
services provided by wholly owned or
wholly operated entities for over a
decade. In 1998, we clarified the
definition of ‘‘wholly owned’’ and
‘‘wholly operated,’’ and we responded
to comments on specific owner and
operator relationships (63 FR 6866). In
this rule, we discussed several different
illustrative examples of ownership and
operational interests and how the 3-day
payment window will apply in each
circumstance. These examples provide
guidelines to help each entity determine
whether they believe they are wholly
owned or wholly operated by a hospital.
For ease of reference, we are reprinting
those responses here:
• Arrangement: A hospital owns a
physician clinic or a physician practice
that performs preadmission testing for
the hospital. Policy: A hospital-owned
or hospital operated physician clinic or
practice is subject to the payment
window provision. The technical
portion of preadmission diagnostic
services performed by the physician
clinic or practice must be included in
the inpatient bill and may not be billed
separately. A physician’s professional
service is not subject to the window.
• Arrangement: Hospital A owns
Hospital B, which in turn owns Hospital
C. Does the payment window apply if
preadmission services are performed at
Hospital C and the patient is admitted
to Hospital A? Policy: Yes. We would
consider that Hospital A owns both
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Hospital B and Hospital C, and the
payment window would apply in this
situation.
• Arrangement: Corporation Z owns
Hospitals A and B. If Hospital A
performs preadmission services and the
patient is subsequently admitted as an
inpatient to Hospital B, are the services
subject to the payment window? Policy:
No. The payment window does not
apply to situations in which both the
admitting hospital and the entity that
furnishes the preadmission services are
owned by a third entity. The payment
window includes only those situations
in which the entity furnishing the
preadmission services is wholly owned
or operated by the admitting hospital
itself.
• Arrangement: A hospital refers its
patient to an independent laboratory for
preadmission testing services. The
laboratory does not perform testing by
arrangement with the admitting
hospital. Are the laboratory services
subject to the payment window
provisions? Policy: No. The payment
window does not apply to situations in
which the admitting hospital is not the
sole owner operator of the entity
performing the preadmission testing.
• Arrangement: Hospital A is owned
by Corporations Y and Z in a joint
venture. Corporation Z is the sole owner
of Hospital B. Does the payment
window apply when one of these
hospitals furnishes preadmission
services and the patient is admitted to
the other hospital? Policy: No. As noted
previously, the payment window
provision does not apply to situations in
which both the admitting hospital and
the entity that furnishes the
preadmission services are owned or
operated by a third entity.
• Arrangement: A clinic is solely
owned by Corporation Z and is jointly
operated by Corporation Z and Hospital
A. Does the payment window apply if
preadmission services are furnished by
the clinic and the patient is
subsequently admitted to Hospital A?
Policy: No. The payment window does
not apply because Hospital A is neither
the sole owner nor operator of the
clinic.
Comment: Some commenters caution
CMS about using the 855 form as a
definitive source of information on the
owner and operator status of a physician
practice or other entity stating,
correctly, that the 855 forms do not
indicate whether a practice is wholly
owned or wholly operated. Commenters
suggest that CMS will need a different
mechanism to identify ownership
interests.
Response: We agree that the 855 forms
are not a complete record of wholly
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owned or wholly operated status, but
we believe they may furnish contractors
with some information to indicate
entities with wholly owned or wholly
operated status. We encourage entities
to contact their Medicare claims
processing contractor to update any 855
information that may be incomplete or
out of date.
After consideration of the public
comments we received, we are
finalizing our proposal with
clarification of the term ‘‘entity’’ and a
modification of the implementation date
from January 1, 2012 to July 1, 2012.
The 3-day payment window policy
applies to nondiagnostic services that
are clinically related to an inpatient
admission when preadmission services
are furnished in a wholly owned or
wholly operated entity and the patient
is later admitted as an inpatient within
the payment window. In such cases,
Medicare will make payment for the
preadmission services under the
physician fee schedule at the facility
rate. Specifically, a new Medicare
HCPCS modifier PD will be available to
wholly owned or wholly operated
entities beginning January 1, 2012 and
may be appended to Part B claims lines
to identify preadmission services that
are subject to the 3-day window policy.
However, we will not formally
implement the PD modifier for use by
wholly hospital owned or wholly
operated entities until July 1, 2012 in
order to provide wholly owned or
operated entities sufficient time to
coordinate their billing practices for
clinically related nondiagnostic
preadmission services. The PD modifier
will signal claims processing systems to
provide payment only for the PC for
CPT/HCPCS codes with a TC/PC split
and to pay services without a PC/TC
split at the facility rate when they are
provided in the 3-day (or, in the case of
non-IPPS hospitals, 1-day) payment
window. The facility rate will be paid
for codes without a TC/PC split to avoid
duplicate payment for the technical
resources required to provide the
services. We agree with commenters
that the statutory term ‘‘entity’’ is
broader than physician practices or
clinics. Accordingly, we are modifying
our proposal to revise our regulatory
definition of facility practice expense
RVUs at section 42 CFR 414.22 by
revising paragraph (b)(5)(i)(A) to include
a wholly owned or wholly operated
entity. In addition, the technical costs of
diagnostic and related nondiagnostic
services of the wholly owned or wholly
operated entity subject to the 3-day
payment window shall be included on
the hospital’s inpatient claim for the
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related inpatient admission and
reflected appropriately on the hospital
cost report. The definitions of ‘‘wholly
owned’’ and ‘‘wholly operated’’
continue to be those set forth in the
1998 IPPS final rule (63 FR 6864), and
this policy makes no change to the
requirement that all diagnostic services
furnished during the 3-day payment
window must be included on the
hospital claim for the inpatient
admission.
C. Therapy Services—Outpatient
Therapy Caps for CY 2012
Section 1833(g) of the Act (as
amended by section 4541 of the
Balanced Budget Act of 1997) applies an
annual, per beneficiary combined cap
on expenses incurred for outpatient
physical therapy and speech-language
pathology services under Medicare Part
B. A separate but identical cap also
applies for outpatient occupational
therapy services under Medicare Part B.
The caps apply to expenses incurred for
therapy services furnished in outpatient
settings, other than in an outpatient
hospital setting which is described
under section 1833(a)(8)(B) of the Act.
The caps were in effect during 1999,
from September 1, 2003 through
December 7, 2003, and continuously
beginning January 1, 2006. The caps are
a permanent provision, that is, there is
no end date specified in the statute for
therapy caps.
Beginning January 1, 2006, the DRA
provided for exceptions to the therapy
caps until December 31, 2006.
Provisions for the exceptions process for
therapy caps was further extended
through December 31, 2010 pursuant to
four subsequent amendments (in MEIA–
TRHCA, MMSEA, MIPPA, and
Affordable Care Act). Section 1833(g)(5)
of the Act (as amended by section 104
of the MMEA) extended the exceptions
process for therapy caps through
December 31, 2011.
The therapy cap amounts are required
to be updated each year based on the
MEI. The updated cap amount for CY
2012 is computed by multiplying the
cap amount for CY 2011, which is
$1,870, by the MEI for CY 2012, and
rounding to the nearest $10. This
amount is added to the CY 2011 cap to
obtain the CY 2012 cap. Since the MEI
for CY 2012 is 0.6 percent, the therapy
cap amount for CY 2012 is $1,880.
Our authority to provide for
exceptions to therapy caps (independent
of the statutory exclusion for outpatient
hospital therapy services) will expire on
December 31, 2011, unless the Congress
acts to extend it. If the current
exceptions process expires, the caps
will be applicable in accordance with
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the statute, except for services furnished
and billed by outpatient hospital
departments.
IV. Other Provisions of the Final Rule
A. Part B Drug Payment: Average Sales
Price (ASP) Issues
Section 1847A of the Act requires use
of the average sales price (ASP) payment
methodology for payment for drugs and
biologicals described in section
1842(o)(1)(C) of the Act furnished on or
after January 1, 2005. The ASP
methodology applies to most drugs
furnished incident to a physician’s
service, drugs furnished under the DME
benefit, certain oral anti-cancer drugs,
and oral immunosuppressive drugs.
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1. Widely Available Market Price
(WAMP)/Average Manufacturer Price
(AMP)
Section 1847A(d)(1) of the Act states
that ‘‘The Inspector General of HHS
shall conduct studies, which may
include surveys, to determine the
widely available market prices (WAMP)
of drugs and biologicals to which this
section applies, as the Inspector
General, in consultation with the
Secretary, determines to be
appropriate.’’ Section 1847A (d)(2) of
the Act states, ‘‘Based upon such studies
and other data for drugs and biologicals,
the Inspector General shall compare the
ASP under this section for drugs and
biologicals with—
• The widely available market price
(WAMP) for these drugs and biologicals,
(if any); and
• The average manufacturer price
(AMP) (as determined under section
1927(k) (1) of the Act) for such drugs
and biologicals.’’
Section 1847A(d)(3)(A) of the Act
states that, ‘‘The Secretary may
disregard the ASP for a drug or
biological that exceeds the WAMP or
the AMP for such drug or biological by
the applicable threshold percentage (as
defined in subparagraph (B)).’’ Section
1847A(d)(3)(C) of the Act states that if
the Inspector General (OIG) finds that
the ASP for a drug or biological is found
to have exceeded the WAMP or AMP by
this threshold percentage, the OIG
‘‘shall inform the Secretary (at such
times as the Secretary may specify to
carry out this subparagraph) and the
Secretary shall, effective as of the next
quarter, substitute for the amount of
payment otherwise determined under
this section for such drug or biological,
the lesser of—
• The widely available market price
for the drug or biological (if any); or
• 103 percent of the average
manufacturer price as determined under
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section 1927(k)(1) of the Act for the drug
or biological.’’
The applicable threshold percentage
is specified in section 1847A(d)(3)(B)(i)
of the Act as 5 percent for CY 2005. For
CY 2006 and subsequent years, section
1847A(d)(3)(B)(ii) of the Act establishes
that the applicable threshold percentage
is ‘‘the percentage applied under this
subparagraph subject to such
adjustment as the Secretary may specify
for the WAMP or the AMP, or both.’’ In
the CY 2006 (70 FR 70222), CY 2007 (71
FR69680), CY 2008 (72 FR 66258), CY
2009 (73 FR 69752), and CY 2010 (74 FR
61904) PFS final rules with comment
period, we specified an applicable
threshold percentage of 5 percent for
both the WAMP and AMP. We based
this decision on the fact that data was
too limited to support an adjustment to
the current applicable threshold
percentage.
For CY 2011, we proposed to specify
two separate adjustments to the
applicable threshold percentages. When
making comparisons to the WAMP, we
proposed the applicable threshold
percentage to remain at 5 percent. The
applicable threshold percentage that we
proposed for the AMP is addressed later
in this section of the preamble. The
latest WAMP comparison was published
in 2008, and the OIG is continuing to
perform studies comparing ASP to
WAMP. Based on available OIG reports
that have been published comparing
WAMP to ASP, we did not have
sufficient information at the time to
determine that the 5 percent threshold
percentage is inappropriate and should
be changed. As a result, we believed
that continuing the 5 percent applicable
threshold percentage for the WAMP was
appropriate for CY 2011. Therefore, we
proposed to revise § 414.904(d)(3) to
specify the 5 percent WAMP threshold
for CY 2011. After soliciting and
reviewing comments, we finalized our
proposal to continue the 5 percent
WAMP threshold for CY 2011 (75 FR
73469).
For CY 2012, we again proposed to
specify a separate adjustment to the
applicable threshold percentage for
WAMP comparisons. When making
comparisons to the WAMP, we
proposed the applicable threshold
percentage to remain at 5 percent. We
still do not have sufficient information
to determine that the 5 percent
threshold percentage is inappropriate
and, as a result, we believe that
continuing the 5 percent applicable
threshold percentage for the WAMP is
appropriate for CY 2012. As we noted in
the CY 2011 PFS final rule with
comment period (75 FR 73470), we
understand that there are complicated
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73287
operational issues associated with the
WAMP-based substitution policy. We
continue to proceed cautiously in this
area. We remain committed to providing
stakeholders, including providers and
manufacturers of drugs impacted by
potential price substitutions with
adequate notice of our intentions
regarding such, including the
opportunity to provide input with
regard to the processes for substituting
the WAMP for the ASP.
Comment: Several commenters
supported maintaining the WAMP
threshold at 5 percent, and not making
price substitutions based on WAMP
data until a framework has been
developed, proposed, and finalized.
Commenters agreed the price
substitutions based on WAMP should be
treated separately from substitutions
based on AMP. Commenters also cited
concerns about the lack of a specific
definition for WAMP that would allow
for the consistent collection of data and
concerns about the time periods used by
the OIG in their comparisons as reasons
to further delay price substitutions
based on WAMP. One commenter
suggested incorporating a final check
against WAMP into the AMP
substitution policy that is discussed in
the following sections.
Response: We agree with commenters
concerns that the WAMP-based price
substitutions currently are problematic.
Unlike the OIG’s AMP studies, the
published WAMP studies do not show
whether the prices for the examined
groups of drugs consistently exceed the
applicable percentage threshold across
multiple quarters like the AMP studies.
Because of the lack of data regarding
WAMP to ASP comparisons and the
dissimilar approaches in OIG studies,
we will continue to treat WAMP
separately from AMP in our ASP price
substitution policies, and we will not
implement a price substitution policy
based on the comparison of WAMP to
ASP at this time. For this reason, we
decline to adopt the commenter’s
suggestion that we use WAMP as a final
check on AMP-based price
substitutions, which are discussed later
in this rule. However, we will continue
to work with the OIG and stakeholders
to evaluate the relationship between
WAMP and ASP, and based on
comments, we will maintain the WAMP
threshold at 5 percent. We will consider
proposing a policy for the substitution
of WAMP at a later date.
After reviewing the comments, we
will continue to maintain separate price
substitution policies for comparisons
based on WAMP and AMP. We are
finalizing our proposal to continue the
5 percent WAMP threshold for CY2012
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and regulation text at 42 CFR
414.904(d)(3)(iv).
2. AMP Threshold and Price
Substitutions
As mentioned previously in section
V.A.1. of this final rule with comment
period, when making comparisons of
ASP to AMP, the applicable threshold
percentage for CY 2005 was specified in
statute as 5 percent. Section 1847A(d)(3)
of the Act allows the Secretary to
specify adjustments to this threshold
percentage for years subsequent to 2005.
For CY 2006 (70 FR 70222), CY 2007 (71
FR 69680), CY 2008 (72 FR 66258), CY
2009 (73 FR 69752), and CY 2010 (74 FR
61904), the Secretary made no
adjustments to the threshold percentage;
it remained at 5 percent.
For CY 2011, we proposed, with
respect to AMP substitution, to apply
the applicable percentage subject to
certain adjustments such that
substitution of AMP for ASP will only
be made when the ASP exceeds the
AMP by 5 percent in two consecutive
quarters immediately prior to the
current pricing quarter, or three of the
previous four quarters immediately
prior to the current quarter. We further
proposed to apply the applicable AMP
threshold percentage only for those
situations where AMP and ASP
comparisons are based on the same set
of National Drug Codes (NDCs) for a
billing code (that is, ‘‘complete’’ AMP
data).
Furthermore, we proposed a price
substitution policy to substitute 103
percent of AMP for 106 percent of ASP
for both multiple and single source
drugs and biologicals as defined
respectively at section 1847(A)(c)(6)(C)
and (D) of the Act. Specifically, we
proposed that this substitution—
• Would occur when the applicable
threshold percentage has been met for
two consecutive quarters immediately
prior to the current pricing quarter, or
three of the previous four quarters
immediately prior to the current quarter;
• Would permit for a final
comparison between the OIG’s volumeweighted 103 percent of AMP for a
billing code (calculated from the prior
quarter’s data) and the billing code’s
volume weighted 106 percent ASP (as
calculated by CMS for the current
quarter) to avoid a situation in which
the AMP-based price substitution would
exceed that quarter’s ASP; and
• That the duration of the price
substitution would last for only one
quarter.
We also sought comment on other
issues related to the comparison
between ASP and AMP, such as the
following—
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• Any effect of definitional
differences between AMP and ASP,
particularly in light of the definition of
AMP as revised by section 2503 of the
Affordable Care Act;
• The impact of any differences in
AMP and ASP reporting by
manufacturers on price substitution
comparisons; and
• Whether and/or how general
differences and similarities between
AMP and manufacturer’s ASP would
affect comparisons between these two.
In the CY 2011 PFS final rule with
comment, we did not finalize our
proposed adjustments to the 5 percent
AMP threshold or our price substitution
policy because of legislative changes,
regulatory changes, and litigation that
affected this issue. Specifically—
• A preliminary injunction issued by
the United States District Court for the
District of Columbia in National
Association of Chain Drug Stores et al
v. Health and Human Services, Civil
Action No. 1:07–cv–02017 (RCL) was
still in effect;
• We were continuing to expect to
develop regulations to implement
section 2503 of the Affordable Care Act,
which amended the definition of AMP,
and section 202 of the Federal Aviation
Administration Air Transportation
Modernization and Safety Improvement
Act (Pub. L. 111–226) as enacted on
August 10, 2010, which further
amended section 1927(k) of the Act; and
• We proposed to withdraw certain
provisions of the AMP final rule
published on July 17, 2007 (75 FR
54073).
As a result, we finalized the portion
of our proposal that sets the AMP
threshold at 5 percent for CY 2011 and
revised the regulation text accordingly
(75 FR 73471).
The preliminary injunction was
vacated by the United States District
Court for the District of Columbia on
December 15, 2010. Currently, we
continue to expect that regulations to
implement section 2503 of the
Affordable Care Act and section 202 of
the Federal Aviation Administration Air
Transportation Modernization and
Safety Improvement Act will be
developed. However, these statutory
amendments became effective on
October 1, 2010 without regard to
whether or not final regulations to carry
out such amendments have been
promulgated by such date. Moreover,
our Medicaid final rule published on
November 15, 2010 finalized regulations
requiring manufacturers to calculate
AMP in accordance with section
1927(k)(1) of the Act (75 FR 69591).
Since statutory and regulatory
provisions exist and are currently
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utilized by manufacturers for the
calculation and submission of AMP
data, we revisited the AMP threshold
and price substitution issues.
a. AMP Threshold
Section 1847A(d)(3) of the Act allows
the Secretary to specify adjustments to
the AMP threshold percentage for years
subsequent to 2005, and to specify the
timing for any price substitution.
Therefore, for CY 2012, with respect to
AMP substitution, we proposed (76 FR
42829) to apply the applicable
percentage subject to certain
adjustments. Specifically, a price
substitution of AMP for ASP will be
made only when the ASP exceeds the
AMP by 5 percent in two consecutive
quarters immediately prior to the
current pricing quarter, or three of the
previous four quarters immediately
prior to the current quarter.
In general, the ASP methodology
reflects average market prices for Part B
drugs for a quarter. The ASP is based on
the average sales price to all purchasers
for a calendar quarter. The AMP, in
turn, primarily represents the average
price paid by wholesalers for drugs
distributed to retail community
pharmacies and by retail community
pharmacies that purchase drugs directly
from the manufacturers, and also
includes a subset of drugs sold to other
purchasers. Accordingly, while the ASP
payment amount for a billing code may
exceed its AMP for that billing code for
any given quarter, this may reflect only
a temporary fluctuation in market prices
that would be corrected in a subsequent
quarter. We believe this is demonstrated
by how few billing codes exceed the
applicable threshold percentage over
multiple quarters. For example, in the
Inspector General’s report ‘‘Comparison
of Average Sales Prices and Average
Manufacturer Prices: An Overview of
2009,’’ only 11 of 493 examined billing
codes exceeded the applicable threshold
percentage over multiple quarters (OEI–
03–10–00380). We are concerned that
substitutions based on a single quarter’s
ASP to AMP comparison will not
appropriately or accurately account for
temporary fluctuations. We believe that
applying this threshold percentage
adjusted to reflect data from multiple
quarters will account for continuing
differences between ASP and AMP, and
allow us to more accurately identify
those drugs that consistently trigger the
substitution threshold and thus warrant
price substitution.
We further proposed to apply the
applicable AMP threshold percentage
only for those situations where AMP
and ASP comparisons are based on the
same set of NDCs for a billing code (that
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is, ‘‘complete’’ AMP data). Prior to 2008,
the OIG calculated a volume-weighted
AMP and made ASP and AMP
comparisons only for billing codes with
such ‘‘complete’’ AMP data. In such
comparisons, a volume-weighted AMP
for a billing code was calculated when
NDC-level AMP data was available for
the same NDCs used by us to calculate
the volume-weighted ASP. Beginning in
the first quarter of 2008, the OIG also
began to make ASP and AMP
comparisons based on ‘‘partial’’ AMP
data (that is, AMP data for some, but not
all, NDCs in a billing code). For these
comparisons, the volume-weighted
AMP for a billing code is calculated
even when only such limited AMP data
is available. That is, the volumeweighted AMP calculated by the
Inspector General is based on fewer
NDCs than the volume-weighted ASP
calculated by CMS. Moreover, volumeweighted ASPs are not adjusted by the
Inspector General to reflect the fewer
number of NDCs in the volumeweighted AMP.
Because the OIG’s partial AMP data
comparison did not reflect all of the
NDCs used in our volume-weighted ASP
calculations, we discussed our concern
about using the volume-weighted AMP
in the CY 2011 PFS proposed rule. We
believed that such AMP data may not
adequately account for market-related
drug price changes and may lead to the
substitution of incomplete and
inaccurate volume-weighted prices.
Payment amount reductions that result
from potentially inaccurate
substitutions may impact physician and
beneficiary access to drugs. Therefore,
consistent with our authority as set forth
in section 1847A(d)(1) and (3) of the
Act, we proposed in the CY 2011 PFS
proposed rule that the substitution of
103 percent of AMP for 106 percent of
ASP should be limited to only those
drugs with ASP and AMP comparisons
based on the same set of NDCs.
In response to our CY 2011 proposed
rule, the OIG changed its methodology
for ‘‘partial’’ AMP data comparisons
beginning with its report titled
‘‘Comparison of First-Quarter 2010
Average Sales Prices and Average
Manufacturer Prices: Impact on
Medicare Reimbursement for Third
Quarter 2010.’’ Specifically, in addition
to calculating a volume-weighted AMP
based on ‘‘partial’’ data and identifying
billing codes that exceeded the price
substitution threshold, the OIG began to
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replace each missing NDC-level AMP
with corresponding NDC-level ASP
data. The OIG then calculated a volumeweighted AMP for the billing code. If
the volume-weighted AMP continued to
exceed the price substitution threshold,
the report attributed this to an actual
difference between ASPs and AMPs in
the marketplace (OEI–03–10–00440).
We appreciate that the Inspector
General has acknowledged the
importance of protecting beneficiary
and physician access in its methodology
change. However, section
1847(A)(d)(2)(B) of the Act specifically
indicates that the comparison be made
to AMP as determined under section
1927(k)(1) of the Act. Moreover, we
continue to be concerned that
comparisons based on partial AMP data
may not adequately account for marketrelated drug price changes and may lead
to the substitution of incomplete and
inaccurate volume-weighted prices.
Therefore, for CY 2012, we proposed to
apply the applicable AMP threshold
percentage only for those situations
where AMP and ASP comparisons are
based on the same set of NDCs for a
billing code (that is, ‘‘complete’’ AMP
data). Furthermore, we proposed to
revise § 414.904(d)(3) to reflect
corresponding regulatory text changes.
Comment: One commenter supported
the proposal to continue the use of a 5
percent applicable AMP threshold
percentage. However, one commenter
expressed specific concerns that a 5
percent threshold might not be accurate
for CY 2012 given the changes to the
statutory definition of AMP and the lack
of detailed guidance available to the
public about the reporting of AMP.
Other commenters also expressed more
general concerns about what they
described as potential changes to the
relationship of ASP and AMP because of
the statutory changes to the definition of
AMP.
Response: We will discuss general
comments on the relationship of AMP
and ASP in the following sections. With
respect to the applicable AMP threshold
percentage, we have no specific
information that indicates that the
threshold percentage should be
modified at this time and we agree with
the comment supporting the continued
use of the 5 percent threshold. The 5
percent threshold has been in place
since CY 2005.
Comment: Several commenters agreed
with the concept of safeguards or limits
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73289
on the application of AMP-based price
substitutions. The commenters
specifically agreed with basing price
comparisons (and related calculations)
on the same sets of NDCs because it is
a more exact comparison than the use of
unmatched sets of NDCs and is expected
to more accurately reflect trends in the
marketplace. One comment also
suggested that AMP and ASP be
calculated using the same sales
volumes.
Response: We will discuss comments
about additional safeguards we will use
in the application of AMP based price
substitutions, including duration of the
substitution, and the exclusion of codes
that exceed AMP for only one quarter in
the following sections. We agree that the
use of ‘‘complete’’ AMP data is likely to
provide a more accurate comparison
than the use of unmatched sets of NDCs,
and we believe that the use of
‘‘complete’’ data will result in
consistent volume weighting for ASP
and AMP.
After reviewing the public comments,
we are finalizing the 5 percent threshold
for AMP comparisons for CY 2012 and
the corresponding regulation text at 42
CFR 414.904(d)(3)(iii) as proposed,
except that we are correcting one
typographical error in which we
referred to ASP instead of AMP. We are
also finalizing the proposal that
specifies that the AMP for a billing code
is calculated using the same set of NDCs
used to calculate the ASP for the billing
code and corresponding regulation text
at 42 CFR 414.904(d)(3)(iii)(B).
b. AMP Price Substitution
(1) Inspector General Studies
Section 1847A(d) of the Act requires
the Inspector General to conduct studies
of the widely available market price for
drugs and biologicals to which section
1847A of the Act applies. However, it
does not specify the frequency of when
such studies should be conducted. The
Inspector General has conducted studies
comparing AMP to ASP for essentially
each quarter since the ASP system has
been implemented. Since 2005, the OIG
has published 25 reports pertaining to
the price substitution issue (see Table
36), of which 23 have identified billing
codes with volume-weighted ASPs that
have exceeded their volume-weighted
AMPs by the applicable threshold
percentage.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
In the quarterly report comparing
AMP to ASP, titled ‘‘Comparison of
Third-Quarter 2010 Average Sales Price
and Average Manufacturer Prices:
Impact on Medicare Reimbursement for
First Quarter 2011’’ (OEI–03–11–00160),
the Inspector General found that of 365
billing codes with ‘‘complete’’ AMP
data in the third quarter of 2010, only
14 met the 5 percent threshold; that is,
ASP exceeded AMP by at least 5
percent. Eight of these 14 billing codes
also exceeded the AMP by at least 5
percent in one or more of the previous
four quarters; only two drugs had ASPs
that exceeded the 5 percent threshold in
all four quarters under review. This
Inspector General report further
indicates that, ‘‘If reimbursement
amounts for all 14 codes with complete
AMP data had been based on 103
percent of the AMPs during the first
quarter of 2011, we estimate that
Medicare expenditures would have been
reduced $10.3 million in that quarter
alone.’’ The savings found by the
Inspector General constitute potential
savings for the Medicare program and
beneficiaries. Since the publication of
the proposed rule, the OIG has released
two additional AMP comparison studies
(OEI–03–11–00540, and OEI–03–11–
00360)., Report OEI–03–11–00360,
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entitled ‘‘Comparison of Fourth Quarter
2010 Average Sales Prices and Average
Manufacturer Prices: Impact on
Medicare Reimbursement for Second
Quarter 2011,’’ has findings that
indicate the potential for cost savings
through the implementation of price
substitution, and it states that ‘‘of the
338 drug codes with complete AMP
data, 15 exceeded the 5 percent
threshold. If reimbursement amounts for
all 15 codes had been based on 103
percent of the AMPS in the second
quarter of 2011, Medicare would have
saved an estimated $1.3 million. Under
CMS proposed price substitution policy,
reimbursement amounts for 5 of the 15
drugs would have been reduced, saving
an estimated $554,000.’’ The more
recent report describes more modest
cost savings than the report cited in the
proposed rule.
(2) Proposal
As discussed previously, section
1847A(d)(3) of the Act provides
authority for us to determine the
applicable percentage subject to ‘‘such
adjustment as the Secretary may specify
for the widely available market price or
the average manufacturer price, or
both.’’ We also have authority to specify
the timing of any ASP substitution.
Consistent with this authority, we
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73291
proposed a policy to substitute 103
percent of AMP for 106 percent of ASP
where the applicable percentage
threshold has been satisfied for the two
consecutive quarters immediately prior
to the current pricing quarter, or for
three of the previous four quarters
immediately prior to the current pricing
quarter. This policy would apply to
single source drugs and biologicals,
multiple source drugs, and biosimilar
biological products as defined at section
1847A(c)(6)(C), (D), and (H) of the Act.
Comment: As mentioned previously,
several commenters agreed with the
concept of safeguards or limits on the
application of AMP-based price
substitutions. Of the commenters who
specifically discussed the duration of
ASP deviations above AMP, all agreed
that deviations lasting only one quarter
could be attributed to temporary market
changes or fluctuations and should not
trigger a piece substitution. There were
no comments regarding which subsets
of part B drugs or biologicals that the
policy should apply to.
Response: We agree with the
commenters and believe that focusing
on those drugs that consistently exceed
the applicable percentage threshold over
multiple quarters is appropriate because
we believe such an approach will
minimize the potential for disruption to
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access in cases of temporary market
fluctuations.
After reviewing the public comments,
we are finalizing our proposal that
implements the substitution of 103
percent of AMP for 106 percent of ASP
where the applicable percentage
threshold has been satisfied for the two
consecutive quarters immediately prior
to the current pricing quarter, or for
three of the previous four quarters
immediately prior to the current pricing
quarter and corresponding regulation
text at 42 CFR 414.904(d)(3)(iii)(A). This
policy will apply to single source drugs
and biologicals, multiple source drugs,
and biosimilar biological products as
defined at section 1847A(c)(6)(C), (D),
and (H) of the Act.
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(3) Timeframe for and Duration of Price
Substitutions
As stated in § 414.804(a)(5), a
manufacturer’s average sales price must
be submitted to CMS within 30 days of
the close of the quarter. We then
calculate an ASP for each billing code
in accordance with the process outlined
at § 414.904. Then, as described in our
CY 2005 PFS final rule (69 FR 66300),
we implement these new prices through
program instructions or otherwise at the
first opportunity after we receive the
data, which is the calendar quarter after
receipt.
Section 1847A(d)(3)(C) of the Act
indicates that a price substitution would
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be implemented ‘‘effective as of the next
quarter’’ after the OIG has informed us
that the ASP for a drug or biological
exceeds its AMP by the applicable
percentage threshold. The OIG does not
receive new ASPs for a given quarter
until after we have finalized our
calculations for the quarter. Also, the
results of the OIG’s pricing comparisons
are not available until after the ASPs for
a given quarter have gone into effect.
Therefore, we anticipate that there will
be a three-quarter lag for substituted
prices from the quarter in which
manufacturer sales occurred, though
this will depend in great part upon the
timeframe in which we obtain
comparison data from the OIG. Table 37
provides an example of this timeframe.
Comment: Two commenters
expressed concern about the three
quarter lag, how the duration
disconnects price substitution policy
from the marketplace, and the potential
for divergence between ASP and AMP
during the lag period. One commenter
suggested that the proposal not be
implemented unless a shorter
turnaround could be put in place; one
commenter stated that the lag should
not exceed the ASP methodology’s two
quarter lag. Another commenter stated
that the associated regulation text at 42
CFR 414.904(d)(iii)(A) may not
accurately describe the timeframes for
the comparisons because the
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comparison is not actually done using
data from quarters that immediately
precede the substitution.
Response: In developing our policy,
we carefully considered the lag
associated with the AMP based price
substitution. ASPs reported to the OIG
incorporate a two quarter lag between
the reported sales and the time that an
ASP is posted. Section 1847A(d)(3)(C) of
the Act provides that the Secretary
substitute prices as of the next quarter
after the OIG informs the Secretary that
the ASP exceed the AMP by the
applicable threshold. This results in a
minimum of a three quarter lag from the
date that manufacturer sales occurred
for the price substituted products and
the price substitution. Given the current
operational environment and the
statutory requirement to implement
price substitutions after the OIG
provides information about drugs for
which ASP exceed AMP by the
applicable threshold (which is also
reflected in regulation text at 42 CFR
414.904(d)(i)), it is not possible to
reduce the lag at this time. We disagree
with the assertion that the regulation
text does not accurately describe the
time frame for our price substitution
policy. Our policy for comparisons
between AMP and ASP is discussed
later in this preamble and reflects the
use of data from the most recent quarter
where OIG data and ASPs are available.
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Given this lag in time, the ASP for a
billing code may have decreased since
the OIG’s comparison. Therefore,
consistent with our authorities in
section 1847A(d)(3) of the Act and our
desire to provide accurate payments
consistent with these provisions, we
believe that the timing of any
substitution policy should permit a final
comparison between the OIG’s volumeweighted 103 percent AMP for a billing
code (calculated from the data from
sales three quarters prior) and the
billing code’s volume-weighted 106
percent ASP (as calculated by CMS for
the upcoming quarter). In Table 37 for
example, this comparison would be
done between the HCPCS payment
limits calculated for Q1–12, and the
OIG’s volume-weighted AMPs from
their examination of Q4–11 payment
limits. This final comparison would
assure the Secretary that the 106 percent
ASP payment limit for the current
pricing quarter continues to exceed 103
percent of the OIG’s calculated AMP in
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order to avoid a situation in which the
Secretary would inadvertently raise the
Medicare payment limit through this
price substitution policy. We
specifically requested comments on this
proposal.
Comment: We did not receive any
specific comments about this issue.
However several commenters touched
on issues related to the final
comparison. One commenter expressed
concerns that there is no mechanism to
rescind a substitution, while another
comment remarked about the fact that
AMPs could be restated for up to 12
quarters, and stated the assumption that
a restated AMP would be used in the
final comparison. Another commenter
(discussed in section VI.A.1. of this final
rule with comment period) suggested
that WAMP be incorporated into the
proposed final check.
Response: We appreciate the
comments that have asked us to
consider additional limits or safeguards
related to the implementation of the
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73293
AMP-based price substitution. As we
developed the details of this proposal,
we considered the lag period and the
impact of brief periods where ASP
exceeds AMP by more than the
threshold percentage. At this time we
still believe that when all of our limits
(the comparison of ‘‘complete’’ AMP
data against ASPs for the same NDCs,
the 5 percent threshold, the requirement
that ASP exceed the threshold for more
than one quarter, and the final check
against 106 percent of ASP that would
otherwise be applied in a quarter) are
considered together, they create
satisfactory safeguards to prevent the
inadvertent or unnecessary triggering of
a price substitution, which, in turn,
could affect provider payments and
access to drugs. We also do not believe
that additional limits or safeguards,
particularly ones that have not already
been proposed, should be applied at this
time because they will not be subject to
public comment.
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We would like to clarify that our
approach utilizes the OIG’s calculation
of AMP and does not incorporate the
use of restated AMPs. We are not
persuaded to incorporate restated AMPs
into the calculation because, as
discussed earlier in the rule and noted
by commenters, AMP can fluctuate from
quarter to quarter. The use of a restated
AMP would require additional
calculations and the incorporation of
additional analysis similar to the
safeguards finalized in this rule that
confirm that the AMP to ASP
comparison is not just a one quarter
fluctuation that may not represent the
actual state of the marketplace. The use
of restated AMPs may also lead to
comparisons that are beyond the 3
quarter lag and changes the comparison
from one based on a single quarter to
being based on potentially changing
data; the ASP methodology generally
relies on data from a single time period.
We believe that additional pricing
variations, which could result from the
use of restated AMPs over multiple
quarters could further increase
providers’ uncertainty about payment
rates. The final comparison between the
OIG’s volume-weighted 103 percent
AMP for a billing code (calculated from
the data from sales three quarters prior)
and the billing code’s volume-weighted
106 percent ASP (as calculated by CMS
for the upcoming quarter) is intended to
minimize the effect of the three quarter
lag and further minimize the effect of
AMP fluctuation on our substitution
policy, and we believe that this final
check, as well as the additional
safeguards described in this rule, are
sufficient. An additional check based on
restated AMP is not necessary at this
time.
After reviewing the public comments,
we are finalizing our proposal regarding
the final comparison between AMP and
ASP and the related regulation text at 42
CFR 414.904(d)(3)(ii)(B).
ASP payment limits are calculated on
a quarterly basis as per section
1847A(c)(5)(A) of the Act, and we are
particularly mindful that the ASP-based
payment allowance for a billing code
may change from quarter to quarter. As
such, we proposed that any price
substitution based on the comparison
that triggered its application would last
for one quarter.
Comment: Several commenters
supported the one quarter duration for
the price substitution.
Response: We agree with the
comments. No commenters provided
alternatives to the one quarter duration
of the price substitution.
We are finalizing the one quarter
duration for AMP-based price
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substitutions and the related regulation
text at § 414.904(d)(3)(i). We note that in
a subsequent quarter, the OIG may
identify that a volume-weighted ASP
continues to exceed the volumeweighted AMP for a billing code that
previously triggered a price substitution.
In this scenario, if the criteria for the
price substitution policy are met, we
would substitute 103 percent of the
OIG’s updated volume-weighted AMP
for that billing code.
(4) Implementation of AMP-Based Price
Substitution and the Relationship of
ASP to AMP
In the preceding section, we have
discussed various details, limitations,
and safeguards regarding the AMPbased price substitutions. In general,
comments regarding these items
supported our proposals regarding those
items, and agreed that we were being
consistent with the cautious approach
described in the proposal and previous
rules. In this section, we will discuss
whether the AMP based price
substitutions should be implemented in
CY 2012.
In general, we believe that our
proposal to substitute 103 percent of
AMP for 106 percent of ASP provides us
with a viable mechanism for generating
savings for the Medicare program and
its beneficiaries because it will allow
Medicare to pay based on lower market
prices for those drugs and biologicals
that consistently exceed the applicable
threshold percentage. Moreover, it will
enable us to address a programmatic
vulnerability identified by the OIG.
In the CY 2010 proposed rule, we
sought comment on other issues related
to the comparison between ASP and
AMP, and in the CY 2012 proposed rule
we sought comments on the following
issues again—
• The effect of definitional
differences between AMP and ASP,
particularly in light of the definition of
AMP as revised by section 2503 of the
Affordable Care Act;
• The impact of any differences in
AMP and ASP reporting by
manufacturers on price substitution
comparisons; and
• Whether and/or how general
differences and similarities between
AMP and manufacturer’s ASP would
affect comparisons between these two.
Although most commenters agree
with specific details of our proposals
that we described and finalized, nearly
all of the commenters were concerned
about the impact of recent changes to
the definition of AMP and how they
would affect the relationship of AMP to
ASP.
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Comment: Comments disagreeing
with the proposed CY 2012
implementation of the AMP-based price
substitution policy generally related to
the three previous bullet points and
cited the following concerns:
• A lack of experience with the new
definitions of AMP and an incomplete
understanding of the relationship
between ASP and the new definitions of
AMP by the industry and CMS,
particularly for AMP reporting of drugs
with payment limits that are determined
under the ASP methodology.
Commenters indicated that the
definition of AMP in the Affordable
Care Act that describes drugs sold to
retail community pharmacies is
expected to increase AMP, but
commenters expressed uncertainty
about how the updated definition in the
FAA Air Transportation Modernization
and Safety Improvement Act would
affect the AMP/ASP relationship.
• A lack of guidance in recent
rulemaking and statutory provisions
about assumptions that manufacturers
should use in order to uniformly
calculate AMP. In particular,
commenters were concerned about how
the phrase ‘‘not generally dispensed
through a retail community pharmacy,’’
which was added in the updated
definition of AMP in the FAA Air
Transportation Modernization and
Safety Improvement Act, might be
defined in rulemaking;
• Uncertainty about how future
rulemaking regarding the AMP would
affect the ASP/AMP relationship;
• Inconsistency in how AMP and
ASP incorporate prompt pay discounts;
and
• Concern about any further
reductions in payments to providers,
particularly small practices and the
potential effect on access to care.
Commenters also stated that
implementation of a price substitution
policy in 2012 was not consistent with
the ‘‘slow and cautious’’ approach that
we have described in previous
rulemaking. They recommended
delaying the implementation of a price
substitution policy until additional
guidance about AMP has been finalized
and more experience has been gained.
Response: We agree that the definition
of AMP has continued to evolve over
time. The updated definitions of AMP
in section 2503 of the Affordable Care
act and section 202 of the Federal
Aviation Administration Air
Transportation Modernization and
Safety Act (which includes injected,
infused, implanted, instilled, and
inhaled drugs) became effective on
October 1, 2010 and remain in effect at
this time. Although rulemaking that
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pertains to specific issues and
operational details regarding
manufacturer reporting of AMP is
pending, the current reporting process,
including the updated definitions of
AMP, is in place. Although we
appreciate the comments that
recommended that we delay the
implementation of the AMP-based price
substitution policy until a later time, we
do not believe implementation of a price
substitution policy should be further
delayed for a number of reasons.
First, we disagree that
implementation of the policy in CY
2012 is inconsistent with a slow and
cautious approach regarding price
substitution. While additional guidance
and experience with the new definitions
of AMP would be helpful, our 6-years’
experience in monitoring AMP and ASP
have shown that very few ASP payment
limits exceed the existing AMP
threshold (even absent the safeguards
that we are finalizing in this rule).
Moreover, most of the drugs that exceed
the threshold in previous reports are
infrequently used. We understand that
the updated definition of AMP
encompasses sales of injected, infused,
instilled, inhaled, and implanted drugs
that are not generally dispensed through
a retail community pharmacy, including
a wider range of customers and
discounted sales to non-pharmacy
entities, and commenters’ concerns that
implementation of the most recent
definition could decrease AMP for
certain drugs. However, we do not have
any specific information from
commenters that persuades us to believe
that the AMP-based price substitution
policy will be applied frequently or to
high cost/high volume items, despite
the changes to the definition of AMP.
Therefore, we believe that proceeding
with implementation in 2012 is
consistent with a slow and cautious
approach toward this policy.
Second, we have worked closely with
the OIG and have reviewed 25 price
substitution reports from the OIG over
the past 6 years. The drugs and
biologicals identified as candidates for
price substitution were typically
uncommonly used and many were
inexpensive items. Based on this
experience, we do not believe that this
policy will substantially affect
providers’ financial situation, access to
care for beneficiaries, the payment rate
for highly utilized and expensive drugs
and biologicals, or the manufacturers of
these items. Further, we are finalizing in
this rule additional safeguards to
prevent the triggering of the price
substitutions for drugs that do not
consistently exceed the AMP threshold.
We believe these safeguards are both
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consistent with a cautious approach and
provide assurance that the price
substitution policy will be applied only
when appropriate.
Finally, while the Affordable Care Act
did change the definition of AMP, and
AMP data captures sales differently than
ASP, the Congress did not modify its
mandate that the OIG compare AMP to
ASP for purposes of section
1847A(d)(3), nor did it change how
prompt pay discounts are treated under
ASP. Thus, in our view, the statute
requires the Secretary to use AMP, as
modified by the Affordable Care Act and
updated by the FAA Air Transportation
Modernization and Safety Improvement
Act, as the basis for a comparison value
and an alternative payment limit for
ASP, and we will not make further
revisions to the proposed
implementation of this policy at this
time. We appreciate the comments that
we have received regarding this
proposal and we look forward to
continuing to work with the OIG and
stakeholders on this matter.
In summary we are finalizing the
implementation of an AMP based
substitution policy to substitute 103
percent of AMP for 106 percent of ASP
beginning in CY 2012 and proposed
regulation text at 42 CFR 414.904(d)(3),
as described in the ASP section of this
rule. We note that although this policy
will become effective on January 1,
2012, because of the three quarter lag,
the earliest that price substitutions
could occur is April 1, 2012.
Comment: Several commenters were
also concerned that there is no
mechanism for public notification and
comments in advance of specific
substitutions. Two commenters
requested that CMS allow for dialogue
about specific substitutions between the
manufacturer and CMS.
Response: Although there is no
statutory requirement that CMS notify
the public about specific price
substitutions or to accept comments
regarding specific substitutions, we
agree that public notification about
specific price substitutions is important
and will help us operate in a transparent
manner. CMS will post a list of the
HCPCS codes for which the policy is
applied at the time that a quarter’s ASPs
are first posted to the CMS ASP Web
site (https://www.cms.gov/
McrPartBDrugAvgSalesPrice/). This will
provide approximately two weeks’
notice before the substituted payment
amount goes into effect. Our experience
with ASP has shown that this two week
notification regarding ASPs has
provided stakeholders with time to
comment and inquire about potential
problems regarding the new quarter’s
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prices, and time for CMS to respond. We
will accept inquiries about the list at the
CMS ASP emailbox at
sec303aspdata@cms.hhs.gov. However,
we have not proposed, nor are we
implementing, a mechanism for
dialogue with stakeholders regarding
specific substitutions, such as formal
dispute resolution procedures, due to
the relatively tight timeframe and
commenters’ concerns about further
increasing the lag period.
3. ASP Reporting Update
a. ASP Reporting Template Update
For purposes of this part, unless
otherwise specified, the term ‘‘drugs’’
will hereafter refer to both drugs and
biologicals. Sections 1847A and 1927(b)
of the Act specify quarterly ASP data
reporting requirements for
manufacturers. Specific ASP reporting
requirements are set forth in section
1927(b)(3) of the Act. For the purposes
of reporting under section 1847A of the
Act, the term ‘‘manufacturer’’ is defined
in section 1927(k)(5) of the Act and
means any entity engaged in the
following: Production; preparation,
propagation, compounding, conversion
or processing of prescription drug
products; either directly or indirectly by
extraction from substances of natural
origin, or independently by means of
chemical synthesis, or by a combination
of extraction and chemical synthesis; or
packaging, repackaging, labeling,
relabeling, or distribution of
prescription drug products. The term
manufacturer does not include a
wholesale distributor of drugs or a retail
pharmacy licensed under State law.
However, manufacturers that also
engage in certain wholesaler activities
are required to report ASP data for those
drugs that they manufacture. Note that
the definition of manufacturers for the
purposes of ASP data reporting includes
repackagers.
Section 1927(b)(3)(A)(iii) of the Act
specifies that manufacturers must report
their average sales price and the number
of units by NDC. As established by 42
CFR part 414 subpart J, manufacturers
are required to report data at the NDC
level, which includes the following
elements: (1) The manufacturer ASP; (2)
the Wholesale Acquisition Cost (WAC)
in effect on the last day of the reporting
period; (3) the number of units sold; and
(4) the NDC. The reported ASP data are
used to establish the Medicare payment
amounts.
Section 1927(b)(3)(A)(iii)(II) of the Act
specifies that the manufacturer must
report the WAC if it is required for
payment to be made under section
1847A of the Act. In the 2004 IFC that
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implemented the ASP reporting
requirements for Medicare Part B drugs
and biologicals (66 FR 17935), we
specified that manufacturers must
report the ASP data to CMS using our
Addendum A template. In 2005, we
expanded the template to include WAC
and additional product description
details (70 FR 70221). We also initiated
additional changes to the template in
2008 (73 FR 76032).
In order to facilitate more accurate
and consistent ASP data reporting from
manufacturers, we have proposed
additional revisions to the Addendum A
template. Specifically, we have
proposed to revise existing reporting
fields and add new fields to the
Addendum A template as follows—
• To split the current NDC column
into three separate reporting fields,
corresponding to the three segments of
an NDC;
• To add a new field to collect an
Alternate ID for products without an
NDC; and
• To expand the current FDA
approval number column to account for
multiple entries and supplemental
numbers.
We have also added a macro to the
Addendum A template that will allow
manufacturers to validate the format of
their data prior to submission. This will
help verify that data are complete and
submitted to CMS in the correct format,
thereby minimizing time and resources
spent on identifying mistakes or errors.
We note that the use of this macro does
not preclude or supersede
manufacturers’ responsibility to provide
accurate and timely ASP data in
accordance with the reporting obligation
under section 1927(b)(3) of the Act. We
also note that manufacturers who
misrepresent or fail to report
manufacturer ASP data will remain
subject to civil monetary penalties, as
applicable and described in sections
1847A and 1927(b) of the Act and
codified in regulations at § 414.806.
Comment: Two commenters requested
that the ‘‘Alternate ID’’ field be
increased to a 23-character capacity
from the proposed 13 character limit.
Both commenters cited specific
instances where their products are
identified by an alpha-numeric
identification that would exceed the
limit of the proposed field.
Response: We agree with the
importance of being able to
accommodate Alternate IDs of various
lengths. We have expanded the
Alternate ID field to accommodate 23
characters. This will ensure the field is
consistent with a variety of existing
alternative product identifiers.
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Comment: A commenter objected to
the description in the revised
Addendum A user guide regarding the
inclusion of negative and zero values as
valid ASP, Units, and WAC. The
commenter stated that the required
inclusion of all discounts in the ASP
could create negative or zero ASP, Units
or WAC values. They believed that
negative numbers are invalid for these
fields and urged CMS to revise the User
Guide to indicate that negative values
are not ‘‘valid’’ for ASP, ASP units, and
WAC in Addendum A. They also
requested that the Guide instead
instruct manufacturers who have
negative values to report ‘‘0.000’’ as
manufacturers are instructed to do when
they have no ASP, ASP units or WAC
to report.
Response: We disagree with this
comment. 1847A(c)(3) in the Act states,
‘‘In calculating the manufacturer’s
average sales price under this
subsection, such price shall include
volume discounts, prompt pay
discounts, cash discounts, free goods
that are contingent on any purchase
requirement, chargebacks, and rebates
* * *.’’ This allows for lagged
discounts, which may in turn create a
negative ASP value. We therefore
maintain the request for negative
numbers within the User Guide and
Addendum A template.
Comment: One commenter requested
that the Agency provide the updated
Addendum A template to manufacturers
as soon as possible to facilitate internal
system changes. The proposal for the
reporting changes to be effective January
1, 2012 would appear to subject
manufacturers to the new reporting
format for the Q4 2011 reporting period
due January 30, 2012. Manufacturers
using their own systems, as well as
those utilizing systems provided by a
third party, will need adequate time to
program and validate the system
changes prior to the submission
deadline.
Response: We agree with the need to
give manufacturers as much time as
possible to incorporate the revisions to
the Addendum A template into their
administrative systems. The finalized
template will be posted online as soon
as possible following the publication of
the CY 2012 PFS final rule. However,
we still require that this template be
used to submit such data that is due at
the end of January 2012. We also remind
readers that submissions will continue
to require certification that reported
Average Sales Prices were calculated
accurately and that all information and
statements made in the submission are
true, complete, and current.
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In summary we are finalizing our
proposal to amend the Addendum A
template, including the use of a data
validation macro and with the
expansion of the ‘‘Alternate ID’’ field.
The companion Users’ Guide and other
documents will be available on our ASP
Web site: https://www.cms.gov/
McrPartBDrugAvgSalesPrice/ as soon as
possible following the publication of
this final rule.
b. Reporting of ASP Units and Sales
Volume for Certain Products
As required by 42 CFR part 414
subpart J, manufacturers report ASP
price and volume data at the NDC level.
This is appropriate for most drug and
biological products because an NDC is
usually associated with a consistent
amount of product that is being sold.
Our experience with manufacturer
reporting of ASPs has revealed that a
limited number of drug products, as
defined by an NDC, might contain a
variable amount of active ingredient.
This situation is common for plasma
derived clotting factors; for example, we
are aware of one product where a vial
described as nominally containing 250
international units (IUs) of clotting
factor activity might actually contain
between 220 and 400 IUs. Although the
exact factor activity is specified on the
label, the amount of IUs contained in an
NDC might vary between manufacturing
lots. For these types of products, it is
possible that vials with the same NDC
but different amounts of clotting factor
activity (as measured in IUs) might be
sold during the same ASP reporting
period. For drugs paid under Medicare
Part B, such variability in the amount of
drug product within an NDC appears to
apply mostly to clotting factors that are
prepared from plasma sources; it also
applies to a few other products,
including a plasma protein product
used to treat antitrypsin deficiency.
As stated in the section 1847A(b)(2) of
the Act, for years after 2004, the
Secretary has the authority to ‘‘establish
the unit for a manufacturer to report and
methods for counting units as the
Secretary determines appropriate to
implement.’’ There are limited
situations when ASP price and volume
reporting by product NDC may affect the
accuracy of subsequent pricing
calculations done by us (for example,
when an NDC is associated with a
variable amount of drug product as
described in the paragraph previously).
We believe that in such cases it is
appropriate to amend the definition of
the ASP unit associated with the NDC
that is reported to us by manufacturers
for the purposes of calculating ASP.
Under the authority in the section
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1847A(b)(2) of the Act, we proposed
that we will maintain a list of HCPCS
codes for which manufacturers report
ASPs for NDCs on the basis of a
specified unit. The specified unit will
account for situations where labeling
indicates that the amount of drug
product represented by an NDC varies.
Our initial list appears in Table 38 and
is limited to items with variable
amounts of drug product per NDC as
described previously. However, we
proposed to update this list as
appropriate through program instruction
or otherwise because we believe that the
ability to make changes in a
subregulatory manner will provide us
with the flexibility to quickly and
appropriately react to sales and
marketing practices for specific drug
products, including the introduction of
new drugs or drug products. We plan to
amend the list as necessary and to keep
updates on the CMS ASP Web site at:
https://www.cms.gov/
McrPartBDrugAvgSalesPrice/
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01_overview.asp. Our proposal would
be effective for ASP reports received on
or after January 1, 2012 and would be
reflected in our April 1, 2012 quarterly
update.
In conjunction with the proposals in
the preceding paragraph and the
expectation that nearly all ASP price
and sales volume reporting will
continue to be at the NDC level (that is,
the reported ASP sales and volume will
be associated with a non-variable
amount that is represented by the NDC),
we proposed a clarification to existing
regulation text at § 414.802. Current
regulation text states that ‘‘Unit means
the product represented by the 11-digit
National Drug Code.’’ We proposed to
update the definition to account for
situations when an alternative unit of
reporting must be used; the definition of
the term unit will continue to be based
on reporting of ASP data per NDC
unless otherwise specified by CMS to
account for situations where the amount
of drug product represented by an NDC
varies.
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Comment: One commenter agreed
with the proposal to revise reporting
instructions for products which contain
variable amounts of drug per NDC in
order to align ASP reporting more
closely with typical industry pricing
conventions and to maintain the
accuracy of ASP determinations, and
recommended that CMS provide as
much advance notice as possible about
changes to the proposed list.
Response: Based on the comment, we
will finalize this provision and the
associated regulation text at 42 CFR
414.802 that defines an ASP ‘‘unit.’’ We
plan to update the list of products that
must be reported in units other than an
NDC that is presented in Table 38, post
it on the CMS ASP Web site (https://
www.cms.gov/
McrPartBDrugAvgSalesPrice/) soon after
the rule is published, and incorporate
updates for new products as discussed
in the proposal.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
The instructions for reporting
products with variable amounts of drug
product, along with general instructions
on completing the revised ASP Data
Form (Addendum A), will be delineated
in a User Guide that will be available on
the ASP Web site. In the User Guide, we
will also be revising our instructions for
the reporting of dermal grafting
products as follows—
• If an NDC is not associated with a
dermal grafting product, manufacturers
should enter the UPC or other unique
identifier (such as an internal product
number) in the alternate ID column; and
• Manufacturers should report ASP
prices and sales volumes for dermal
grafting products in units of area by
square centimeter.
The User Guide will be available on
the CMS ASP Web site at: https://
www.cms.hhs.gov/
McrPartBDrugAvgSalesPrice/
01_overview.asp. The Web site will also
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contain the revised ASP Data Form
(Addendum A) and examples of how
ASP data must be reported and
formatted for submission.
We would also like to remind
manufacturers that additional
information about reporting ASP data to
us is available (for examples, see the
following: (69 FR 17936), (69 FR 66299),
(70 FR 70215), (71 FR 69665), (72 FR
66256), (73 FR 69751), and (74 FR
61904)). Also, a link to the ASP
Frequently Asked Questions (FAQs) is
posted in the ‘‘Related Links Inside
CMS’’ section of the ASP Overview Web
page. We welcome comments on the
ASP reporting proposals that are
described in this section.
2012 as well as general comments on
the coding and payment of skin
substitute products; (3) updating
supplying and dispensing fees for Part
B drugs; (4) low reimbursement rates in
a HCPCS-based claims systems for
pharmacies and other community based
practices; (5) the exclusion of prompt
pay discounts from ASP calculations;
and, (6) a request to pay all Part B drugs
under the Part D benefit.
These comments are outside the scope
of this rule, and therefore are not
addressed in this final rule with
comment period.
4. Out of Scope Comments
Section 651 of MMA requires the
Secretary to conduct a demonstration
for up to 2 years to evaluate the
feasibility and advisability of expanding
coverage for chiropractic services under
Medicare. Current Medicare coverage
We received comments pertaining to:
(1) Coding and pricing for new
molecular diagnostic codes; (2) the
continued use of G0440 and G0441 in
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B. Discussion of Budget Neutrality for
the Chiropractic Services Demonstration
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for chiropractic services is limited to
manual manipulation of the spine to
correct a subluxation described in
section 1861(r)(5) of the Act. The
demonstration expanded Medicare
coverage to include: ‘‘(A) care for
neuromusculoskeletal conditions
typical among eligible beneficiaries; and
(B) diagnostic and other services that a
chiropractor is legally authorized to
perform by the State or jurisdiction in
which such treatment is provided’’. The
demonstration was conducted in four
geographically diverse sites, two rural
and two urban regions, with each type
including a Health Professional
Shortage Area (HPSA). The two urban
sites were 26 counties in Illinois and
Scott County, Iowa, and 17 counties in
Virginia. The two rural sites were the
States of Maine and New Mexico. The
demonstration, which ended on March
31, 2007, was required to be budget
neutral as section 651(f)(1)(B) of MMA
mandates the Secretary to ensure that
‘‘the aggregate payments made by the
Secretary under the Medicare program
do not exceed the amount which the
Secretary would have paid under the
Medicare program if the demonstration
projects under this section were not
implemented.’’
In the CY 2006, 2007, and 2008 PFS
final rules with comment period (70 FR
70266, 71 FR 69707, 72 FR 66325,
respectively), we included a discussion
of the strategy that would be used to
assess budget neutrality (BN) and the
method for adjusting chiropractor fees
in the event the demonstration resulted
in costs higher than those that would
occur in the absence of the
demonstration. We stated that BN
would be assessed by determining the
change in costs based on a pre-post
comparison of total Medicare costs for
beneficiaries in the demonstration and
their counterparts in the control groups
and the rate of change for specific
diagnoses that are treated by
chiropractors and physicians in the
demonstration sites and control sites.
We also stated that our analysis would
not be limited to only review of
chiropractor claims because the costs of
the expanded chiropractor services may
have an impact on other Medicare costs
for other services.
In the CY 2010 PFS final rule with
comment period (74 FR 61926), we
discussed the evaluation of this
demonstration conducted by Brandeis
University and the two sets of analyses
used to evaluate budget neutrality. In
the ‘‘All Neuromusculoskeletal
Analysis,’’ which compared the total
Medicare costs of all beneficiaries who
received services for a
neuromusculoskeletal condition in the
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demonstration areas with those of
beneficiaries with similar characteristics
from similar geographic areas that did
not participate in the demonstration, the
total effect of the demonstration on
Medicare spending was $114 million
higher costs for beneficiaries in areas
that participated in the demonstration.
In the ‘‘Chiropractic User Analysis,’’
which compared the Medicare costs of
beneficiaries who used expanded
chiropractic services to treat a
neuromusculoskeletal condition in the
demonstration areas, with those of
beneficiaries with similar characteristics
who used chiropractic services as was
currently covered by Medicare to treat a
neuromusculoskeletal condition from
similar geographic areas that did not
participate in the demonstration, the
total effect of the demonstration on
Medicare spending was a $50 million
increase in costs.
As explained in the CY 2010 PFS final
rule, we based the BN estimate on the
‘‘Chiropractic User Analysis’’ because of
its focus on users of chiropractic
services rather than all Medicare
beneficiaries with neuromusculoskeletal
conditions, as the latter included those
who did not use chiropractic services
and who may not have become users of
chiropractic services even with
expanded coverage for them (74 FR
61926 through 61927). Users of
chiropractic services are most likely to
have been affected by the expanded
coverage provided by this
demonstration. Cost increases and
offsets, such as reductions in
hospitalizations or other types of
ambulatory care, are more likely to be
observed in this group.
As explained in the CY 2010 PFS final
rule (74 FR 61927), because the costs of
this demonstration were higher than
expected and we did not anticipate a
reduction to the PFS of greater than 2
percent per year, we finalized a policy
to recoup $50 million in expenditures
from this demonstration over a 5-year
period, from CYs 2010 through 2014 (74
FR 61927). Specifically, we are
recouping $10 million for each such
year through adjustments to the
chiropractic CPT codes. Payment under
the PFS for these codes will be reduced
by approximately 2 percent. We believe
that spreading this adjustment over a
longer period of time will minimize its
potential negative impact on
chiropractic practices.
We are continuing the
implementation of the required budget
neutrality adjustment by recouping $10
million in CY 2012. Our Office of the
Actuary estimates chiropractic
expenditures in CY 2012 will be
approximately $470 million based on
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actual Medicare spending for
chiropractic services for the most recent
available year. To recoup $10 million in
CY 2012, the payment amount under the
PFS for the chiropractic CPT codes (CPT
codes 98940, 98941, and 98942) will be
reduced by approximately 2 percent. We
are reflecting this reduction only in the
payment files used by the Medicare
contractors to process Medicare claims
rather than through adjusting the RVUs.
Avoiding an adjustment to the RVUs
would preserve the integrity of the PFS,
particularly since many private payers
also base payment on the RVUs.
The following is the summary of the
public comments we received and our
responses.
Comment: One commenter,
representing chiropractors, indicated
that they continue to oppose our
methodology for assuring budget
neutrality under the demonstration.
Instead of the application of an
adjustment to the national chiropractor
fee schedule, the commenter believes
the Congressional intent was for CMS to
make an adjustment to the totality of
services payable under the Part B Trust
Fund because of the language in section
651(f)(A) of the MMA, which directs the
Secretary to ‘‘provide for the transfer
from the Federal Supplementary
Insurance Trust Fund * * * of such
funds as are necessary for the costs of
carrying out the demonstration projects
under this section.’’ The commenter
states that more information is
necessary to fully understand the
findings provided by the evaluator,
Brandeis University.
Response: Section 651(f)(1)(B) of the
MMA requires that the Secretary ‘‘shall
ensure that the aggregate payments
made by the Secretary under the
Medicare program do not exceed the
amount which the Secretary would have
paid under the Medicare program if the
demonstration projects under this
section were not implemented.’’ The
statute does not specify a particular
methodology for ensuring budget
neutrality, but leaves that decision to
the Secretary. Our methodology meets
the statutory requirement and
appropriately impacts the chiropractic
profession that is directly affected by
the demonstration.
With respect to the commenter that
requested more information, we note
that the final evaluation report, which
describes, among other things, our
methodology for calculating budget
neutrality for this demonstration, is
located on our Web site at the following
URL: https://www.cms.gov/reports/
downloads/Stason_ChiroDemoEvalFinal
Rpt_2010.pdf. The evaluation examined
the impact of expanded coverage for
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chiropractic care on Medicare
expenditures and found that
chiropractic users in the demonstration
areas had higher Medicare expenditures
than chiropractic users in comparison
areas that did not have the expanded
coverage. Therefore, as proposed and
reiterated in the 2006, 2007, 2008, 2009,
2010, and 2011 PFS rules, we are
implementing this methodology and
recouping from the chiropractor fee
schedule codes. Our methodology meets
the statutory requirement for budget
neutrality and appropriately impacts the
chiropractic profession that is directly
affected by the demonstration.
Comment: The same commenter
representing chiropractors noted that
the increase in costs from the
demonstration was completely due to
the Illinois site, and not the other four
sites. The commenter ‘‘has concerns that
the Chicago area did not meet the
criteria for an appropriate
demonstration site for this project.’’ The
commenter believes it is ‘‘premature to
use demonstration findings to estimate
the cost of a national roll out of the
expansion of chiropractic services
without further analysis of the
demonstration project data.’’
Response: Section 651(c)(1) of the Act
required the demonstration be
conducted in 4 geographically diverse
sites, specifically two rural and two
urban regions, with each type including
a HPSA. We discussed the design of this
demonstration with the chiropractic
industry and others prior to
implementation. Based on these
discussions, we included additional
criteria for site selection in the design of
this demonstration. The Chicago area
met the site selection criteria for this
demonstration. We refer readers to the
January 28, 2005 notice (70 FR 4130) for
a discussion of our site selection criteria
and the sites selected for participation
based on these criteria.
Regardless of the differences in the
costs associated with the demonstration
areas, the evaluation conducted by
Brandeis University found that
expanding coverage for chiropractic
services under the demonstration
resulted in increased Medicare
expenditures, and the Secretary must
recoup these costs in order to meet the
budget neutrality requirement of the
law.
In response to the comment
suggesting that the data from this
demonstration should not be used to
estimate the cost of a national rollout of
the expansion of chiropractic services,
we note the data from the demonstration
is the only information CMS had at the
time of the Report to the Congress for
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estimating the costs of a national
rollout.
After consideration of the public
comments received, we are continuing
the implementation of the required
budget neutrality adjustment by
recouping $10 million in CY 2012 by
reducing the payment amount under the
PFS for chiropractic codes (that is, CPT
codes 98940, 98941, and 98942) by
approximately 2 percent.
C. Productivity Adjustment for the
Ambulatory Surgical Center Payment
System, and the Ambulance, Clinical
Laboratory, and DMEPOS Fee Schedules
Section 3401 of the Affordable Care
Act requires that the update factor
under certain payment systems be
annually adjusted by changes in
economy-wide productivity. The year
that the productivity adjustment is
effective varies by payment system.
Specifically, section 3401 of the
Affordable Care Act requires that in CY
2011 (and in subsequent years) update
factors under the ambulatory surgical
center (ASC) payment system, the
ambulance fee schedule (AFS), the
clinical laboratory fee schedule (CLFS)
and the DMEPOS fee schedule be
adjusted by changes in economy wide
productivity. Section 3401(a) of the
Affordable Care Act amends section
1886(b)(3)(B) of the Act to add clause
(xi)(II) which sets forth the definition of
this productivity adjustment. The
statute defines the productivity
adjustment to be equal to the 10-year
moving average of changes in annual
economy-wide private nonfarm business
multifactor productivity (MFP) (as
projected by the Secretary for the 10year period ending with the applicable
fiscal year, year, cost reporting period,
or other annual period). Historical
published data on the measure of MFP
is available on the Bureau of Labor
Statistics’ (BLS) Web site at https://
www.bls.gov/mfp.
As stated in the CY 2012 PFS
proposed rule (76 FR 42834 and 35), the
projection of MFP is currently produced
by IHS Global Insight, Inc. (IGI). The
methodology for calculating MFP for the
ASC payment system, and the AFS,
CLFS, and DMEPOS fee schedules was
finalized in the CY 2011 PFS final rule
with comment period (75 FR 73394
through 73399). As described in the CY
2011 PFS final rule with comment
period (75 FR 73394), IGI replicates the
MFP measure calculated by the BLS
using a series of proxy variables derived
from the IGI US macro-economic
models. For CY 2012, we proposed to
revise the IGI series used to proxy the
labor index used in the MFP forecast
calculation from man-hours in private
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nonfarm establishments (billions of
hours—annual rate) to hours of all
persons in private nonfarm
establishments, (2005 = 100.00),
adjusted for labor composition effects.
We proposed this revision after further
analysis showed that the proposed
series is a more suitable proxy for the
BLS private nonfarm business sector
labor input series since it accounts for
the changes in skill-mix of the
workforce over time (referred to above
as labor composition effects). The BLS
labor input series includes labor
composition effects. We did not propose
any additional changes to the IGI MFP
forecast methodology or its application
to the CPI–U update factors for the ASC
payment system, and the AFS, CLFS,
and DMEPOS fee schedules.
We received one comment on our
proposal to revise the labor proxy used
to forecast MFP.
Comment: A commenter stated that
CMS did not explain what the practical
effect on reimbursements is likely to be
after incorporating the new labor proxy.
The commenter claimed that without
this information, stakeholders are
unable to provide comments on the
effect of this change. The commenter
urged CMS to provide a full explanation
of how the proposed change is likely to
impact the various fee schedules to
which it will apply and also requested
that CMS delay the implementation of
this proposal in order to give the full
and fair opportunity to comment.
Response: We disagree with the
commenter’s claim that we did not
provide sufficient detail to comment on
our proposal to revise the labor proxy
used to calculate the MFP forecast. As
stated in the CY 2012 proposed rule, our
proposal to revise the labor proxy was
based on our determination of the most
technically appropriate labor proxy that
most closely approximates the BLS
private nonfarm business sector labor
input series that is used to calculate BLS
historical MFP. We note that when we
evaluated the various labor proxies, we
found that the correlation coefficient
between the proposed revised IGI labor
proxy and the BLS labor proxy was
0.992 compared to a correlation
coefficient between the IGI labor proxy
for CY 2011 and the BLS labor proxy of
0.987. Stated differently, the proposed
IGI labor proxy is more consistent both
in concept and in its movements with
BLS’ published labor proxy. Therefore,
we believe that the proposal to revise
the labor proxy is technically
appropriate and helps achieve our
objective to replicate the BLS historical
MFP measure as closely as possible. We
believe that enough detail was provided
regarding the revised labor proxy for
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stakeholders to comment since the
proposed revision to the labor proxy
was not based on the impact of this
revision on the MFP forecast, but on the
determination of a more technically
suitable approximation of the BLS labor
input series as explained in the
proposed rule. However, in response to
the comment, we note that the historical
average growth in the revised IGI labor
proxy tended to be just slightly higher
than the historical average growth of the
IGI labor proxy for CY 2011.
Therefore, we are finalizing our
proposal to use hours of all persons in
private nonfarm establishments, (2005 =
100.00), adjusted for labor composition
effects as the proxy for labor index used
in the MFP forecast calculation.
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D. Clinical Laboratory Fee Schedule:
Signature on Requisition
1. History and Overview
In the March 10, 2000 Federal
Register (65 FR 13082), we published a
proposed rule entitled ‘‘Medicare
Program; Negotiated Rulemaking:
Coverage and Administrative Policies
for Clinical Diagnostic Laboratory
Services,’’ to announce and solicit
comments on the results of our
negotiated rulemaking committee tasked
to establish national coverage and
administrative policies for clinical
diagnostic laboratory services payable
under Part B of Medicare.
In the November 23, 2001 Federal
Register (66 FR 58788), we published a
final rule, which established these
national coverage and administrative
policies. In that final rule, we explained
our policy on ordering clinical
diagnostic laboratory services and
revised regulatory language in § 410.32.
Our regulation at § 410.32(a) includes a
requirement that states ‘‘[a]ll diagnostic
x-ray tests, diagnostic laboratory tests,
and other diagnostic tests must be
ordered by the physician who is treating
the beneficiary.’’ In the November 23,
2001 final rule (66 FR 58809), we added
paragraph (d)(2) to § 410.32 to require
that the physician or qualified
nonphysician practitioner (NPP) (that is,
clinical nurse specialists, clinical
psychologists, clinical social workers,
nurse-midwives, nurse practitioners,
and physician assistants) who orders the
service must maintain documentation of
medical necessity in the beneficiary’s
medical record. In both the March 10,
2000 proposed rule (65 FR 13089) and
the November 23, 2001 final rule (66 FR
58802), we noted that ‘‘[w]hile the
signature of a physician on a requisition
is one way of documenting that the
treating physician ordered the test, it is
not the only permissible way of
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documenting that the test has been
ordered.’’ In the preamble of these rules,
we described the policy of not requiring
physician signatures on requisitions for
clinical diagnostic laboratory tests, but
implicitly left in place the existing
requirements for a written order to be
signed by the ordering physician or NPP
for clinical diagnostic laboratory tests,
as well as other types of diagnostic tests.
We further stated, in the March 10, 2000
proposed rule (65 FR 13089) and the
November 23, 2001 final rule (66 FR
58802), that we would publish
instructions to Medicare contractors
clarifying that the signature of the
ordering physician or NPP on a
requisition for a clinical diagnostic
laboratory test, is not required for
Medicare purposes.
On March 5, 2002, we issued a
program memorandum (Transmittal
AB–02–030, Change Request 1998)
implementing the administrative
policies set forth in the November 23,
2001 final rule, including the following
instruction:
Medicare does not require the signature of
the ordering physician on a laboratory
service requisition. While the signature of a
physician on a requisition is one way of
documenting that the treating physician
ordered the service, it is not the only
permissible way of documenting that the
service has been ordered. For example, the
physician may document the ordering of
specific services in the patient’s medical
record.
On January 24, 2003, we issued a
program transmittal (Transmittal 1787,
Change Request 2410) to manualize the
March 5, 2002 program memorandum.
The transmittal page, entitled ‘‘Section
15021, Ordering Diagnostic Tests,
manualizes Transmittal AB–02–030,
dated March 5, 2002’’, stated: ‘‘In
accordance with negotiated rulemaking
for outpatient clinical diagnostic
laboratory services, no signature is
required for the ordering of such
services or for physician pathology
services.’’ In the manual instructions in
that transmittal (that is, Transmittal
1787), we stated in a note: ‘‘No signature
is required on orders for clinical
diagnostic tests paid on the basis of the
physician fee schedule or for physician
pathology services.’’ The manual
instructions inadvertently omitted the
reference to clinical diagnostic
laboratory tests. Thus, the transmittal
seemed to extend the policy set forth in
the November 23, 2001 final rule (that
no signature is required on requisitions
for clinical diagnostic laboratory tests
paid under the CLFS) to also apply to
clinical diagnostic tests paid on the
basis of the PFS and physician
pathology services. In addition, the
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73301
manual instructions used the term
‘‘order’’ instead of ‘‘requisition,’’ which
we understand caused some confusion.
In addition, when we transitioned from
paper manuals to the current electronic
Internet Only Manual (IOM) system,
these manual instructions were
inadvertently omitted from the new
Benefit Policy Manual (BPM).
On August 28, 2008, we issued a
program transmittal (Transmittal 94,
Change Request 6100) to update the
BPM to incorporate language that was
previously contained in section 15021
of the Medicare Carriers Manual. The
reissued language stated, ‘‘No signature
is required on orders for clinical
diagnostic tests paid on the basis of the
clinical laboratory fee schedule, the
physician fee schedule, or for physician
pathology services.’’ After the
publication of the August 2008 Program
Transmittal (Transmittal 94), we
received numerous inquiries from
laboratories, diagnostic testing facilities,
and hospital representatives who had
questions about whether the provision
applied to all diagnostic services,
including x-rays, magnetic resonance
imaging (MRIs), and other nonclinical
laboratory fee schedule diagnostic
services.
To resolve any confusion surrounding
the implementation of the CLFS policy
in 2001 and subsequent transmittals, we
restated and solicited public comments
on our policy in the July 13, 2009
proposed rule (74 FR 33641 and 33642),
entitled ‘‘Medicare Program; Payment
Policies Under the Physician Fee
Schedule and Other Revisions to Part B
for CY 2010’’ (CY 2010 PFS proposed
rule). At that time, our policy was that
the signature of a physician or NPP was
not required on a requisition for clinical
diagnostic laboratory tests paid on the
basis of the CLFS. However, we were
clear that we would still require that it
must be evident, in accordance with our
regulations at § 410.31(d)(2) and (3), that
the physician or NPP had ordered the
services .
We clarified that this policy regarding
requisitions for clinical diagnostic
laboratory tests would not supersede
other applicable Medicare requirements
(such as those related to hospital
conditions of participation (CoPs)),
which require the medical record to
include an order signed by the
physician or NPP who is treating the
beneficiary. In addition, we stated that
we did not believe that our policy
regarding signatures on requisitions for
clinical diagnostic laboratory tests
supersedes other requirements
mandated by professional standards of
practice or obligations regarding orders
and medical records promulgated by
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Medicare, the Joint Commission, or
State law; nor did we believe the policy
would require providers to change their
business practices.
In the CY 2010 PFS proposed rule (74
FR 33641 and 33642), we also restated
and solicited public comment on our
longstanding policy, consistent with the
principle in § 410.32(a), that a written
order for diagnostic tests including
those paid under the CLFS and those
that are not paid under the CLFS (for
example, that are paid under the PFS or
under the OPPS), such as X-rays, MRIs,
and the technical component (TC) of
physician pathology services, must be
signed by the ordering physician or
NPP. We were clear that the policy that
signatures are not required on
requisitions for clinical diagnostic
laboratory tests paid under the CLFS
applied only to requisitions (as opposed
to written orders).
Additionally, in the CY 2010 PFS
proposed rule (74 FR 33642) we
solicited public comments about the
distinction between an order and a
requisition. We noted that an ‘‘order’’ as
defined in our IOM, 100–02, Chapter 15,
Section 80.6.1, is a communication from
the treating physician or NPP requesting
that a diagnostic test be performed for
a beneficiary. The order may
conditionally request an additional
diagnostic test for a particular
beneficiary if the result of the initial
diagnostic test ordered yields a certain
value determined by the treating
physician or NPP (for example, if test X
is negative, then perform test Y). We
further clarified in the CY 2010 PFS
final rule with comment period (74 FR
61930) that an order may be delivered
via any of the following forms of
communication:
• A written document signed by the
treating physician or NPP, which is
hand-delivered, mailed, or faxed to the
testing facility.
• A telephone call by the treating
physician or NPP or his or her office to
the testing facility.
• An electronic mail, or other
electronic means, by the treating
physician or NPP or his or her office to
the testing facility.
If the order is communicated via
telephone, both the treating physician or
NPP, or his or her office, and the testing
facility must document the telephone
call in their respective copies of the
beneficiary’s medical records.
In contrast, in the CY 2010 PFS
proposed rule (74 FR 33642), we
defined a ‘‘requisition’’ as the actual
paperwork, such as a form, which is
furnished to a clinical diagnostic
laboratory that identifies the test or tests
to be performed for a patient. The
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requisition may contain patient
information, ordering physician
information, referring institution
information, information on where to
send reports, billing information,
specimen information, shipping
addresses for specimens or tissue
samples, and checkboxes for test
selection. We believed the requisition
was ministerial in nature, assisting
laboratories with the billing and
handling of results, and serves as an
administrative convenience to providers
and patients. We believed that a written
order, which may be part of the medical
record, and the requisition, were two
different documents, although a
requisition that is signed may serve as
an order.
During the public comment period for
the CY 2010 PFS proposed rule, we
received numerous comments on these
issues. Subsequently, in the CY 2010
PFS final rule with comment period (74
FR 61931), we stated that we would
continue to carefully consider the issue
of physician signatures on requisitions
and orders and that we planned to
revisit these issues in the future.
In the CY 2011 PFS proposed rule (75
FR 40162 through 40163), we proposed
to require a physician’s or NPP’s
signature on requisitions for clinical
diagnostic laboratory tests paid on the
basis of the CLFS. We stated that we
believed this policy would result in a
less confusing process because a
physician’s signature would be required
for all requisitions and orders,
eliminating the uncertainty over
whether the documentation is a
requisition or an order, whether the type
of test being ordered requires a
signature, or which payment system
does or does not require a physician’s or
NPP’s signature. We also stated that we
believed the requirement would not
increase the burden on physicians and
it would be easier for the reference
laboratory technicians to know whether
a test was appropriately requested,
which would minimize potential
compliance problems for laboratories
during the course of a subsequent
Medicare audit because a signature
would be consistently required. We
solicited public comments on the CY
2011 PFS proposed rule.
After careful consideration of all the
comments received, we finalized our
proposed policy without modification to
require a physician’s or NPP’s signature
on requisitions for clinical diagnostic
laboratory tests paid under the CLFS in
the CY 2011 PFS final rule with
comment period (75 FR 73483), which
became effective on January 1, 2011.
This policy did not affect physicians or
NPPs who chose not to use requisitions
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to request clinical diagnostic laboratory
tests paid under the CLFS. Such
physicians or NPPs could continue to
request such tests by other means, such
as by using the annotated medical
records, documented telephonic
requests, or electronic requests.
2. Proposed Changes
In the June 30, 2011 Federal Register
(76 FR 38344), we proposed to retract
the policy we finalized in the CY 2011
PFS final rule with comment period (75
FR 73483) and reinstate the prior policy
that the signature of the physician or
NPP is not required on a requisition for
Medicare purposes for a clinical
diagnostic laboratory test paid under the
CLFS. We proposed this policy based on
continued and new concerns noted by
stakeholders regarding the practical
effect of the finalized policy on
beneficiaries, physicians, and NPPs.
While we did not solicit further
comments on the signature on
requisition issue in the CY 2011 PFS
final rule with comment period, we did
receive additional feedback from
industry stakeholders on the issue after
its publication in the Federal Register.
Industry stakeholders identified many
scenarios where it would be difficult to
obtain the physician’s or NPP’s
signature on the requisition for clinical
diagnostic laboratory tests paid under
the CLFS. Industry stakeholders
asserted that there are many different
situations where the physician or NPP
would direct staff to prepare
requisitions for laboratory tests, but then
would be unavailable to provide his or
her signature on the requisition. As an
example, and one that was raised by
commenters on the CY 2011 PFS
proposed rule, in the long-term care
setting, the physician is typically not
available in person on a daily basis. In
these cases, the physician may keep
abreast of the patient’s condition by
calling the nursing staff. If a patient’s
condition indicates that a clinical
diagnostic laboratory test is required,
the nursing staff typically transcribes
the order from the physician over the
telephone onto a requisition. The
information has to be transmitted to the
laboratory and, in this scenario, there is
no physician’s or NPP’s signature on the
requisition. Another example that
occurs in many settings, including
nursing homes, all types of hospitals
(inpatient as well as outpatient), and
physician offices, involves specimens
that are packaged for transmission to the
laboratory with a requisition by nursing
staff. Because the specimen often is
transferred directly from the patient to
the nursing staff without, in most cases,
a physician’s or NPP’s intervention, the
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requisition that accompanies the
specimen does not bear the signature of
the physician or NPP.
Even in cases where the physician or
NPP sees the patient in his or her offices
for an appointment and recommends
that clinical diagnostic laboratory
testing be performed, we now better
understand that, typically, the
information is transcribed from the
medical record onto a paper requisition
by office staff after the physician or NPP
and the patient have concluded their
interaction. In practice, we can see how
requiring the physician or NPP to sign
the paper requisition could, in some
cases, be very inconvenient and
disruptive to the physician, NPP, the
beneficiary, and other patients. The
physician or NPP may need to take time
either during appointments with
subsequent patients or between patient
appointments to make sure that the
requisition is signed for a particular
patient prior to his or her departure
from the office. In addition, a
beneficiary might have to wait for a
physician or NPP to complete the
requisition signature process before the
beneficiary could depart from the office.
Another situation identified by
industry stakeholders that we did not
previously consider concerns
physicians or NPPs who maintain
several practice locations. A patient may
see his or her physician or NPP only at
one particular practice location. If that
patient presents to the practice location
with a medical issue that the physician
or NPP believes warrants immediate
laboratory testing, but the physician or
NPP is physically at a different location
that day, the physician or NPP may be
able to direct his or her nursing staff to
prepare a requisition for the laboratory
test. But, if the physician or NPP must
sign the requisition, there could be a
delay of several days or longer before
the physician or NPP is able to do so,
which means the patient would have to
wait to have the laboratory test
performed.
The aforementioned scenarios have
detrimental implications for expeditious
patient care that were not evident to us
until the new policy was effectuated
and we started hearing from
stakeholders in the industry that would
be negatively impacted by the policy. In
response to a comment suggesting that
physicians be educated about this new
requirement to alleviate problems of
non-compliance, we stated, in the CY
2011 PFS final rule with comment
period (75 FR 73482), that we would
update our manuals and direct the
Medicare contractors to educate
physicians and NPPs on this policy.
After publication of the CY 2011 PFS
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final rule with comment period, it
became even clearer to us that some
physicians, NPPs, and clinical
diagnostic laboratories were not aware
of, or did not understand, the policy.
Therefore, in the first calendar quarter
of 2011, we focused on developing
educational and outreach materials to
educate those affected by this policy.
Further, we issued a statement that,
once the educational campaign
conducted in the first quarter of 2011
was fully underway, we would expect
requisitions to be signed. While
developing educational and outreach
materials, we realized how difficult and
burdensome the actual implementation
of this policy was for physicians and
NPPs and that, in some cases, the
implementation of this policy could
have a negative impact on patient care.
At that point, we decided that the better
course of action was to re-examine the
policy.
We re-examined our policy and our
reasons for adopting this policy in light
of industry stakeholders’ comments
received after publication of the CY
2011 PFS final rule with comment
period and comments received on the
CY 2011 PFS proposed rule. We
reviewed our beliefs and assumptions
regarding the effect of our policy on
access to care and with respect to
administrative burden on physicians
and NPPs, the effect on innovation, and
the impact on laboratories. We
originally believed that the policy
would not have a negative impact on
beneficiary access to care. However, we
now believe that we underestimated the
potential impact on beneficiary health
and safety. As discussed previously,
care may be delayed under this policy
in situations where the physician or
NPP orders the test but is not available
onsite to sign the requisition. For
example, we understand there are
concerns that certain populations of
patients, such as nursing home patients
and patients confined to their homes,
may have laboratory tests ordered
urgently by a distant physician or NPP
to obtain information that is imminently
needed in order to assess a need for
immediate referral to a hospital,
emergency department or other facility.
If the ordering physician or NPP is not
onsite, it is unlikely that he or she
would be able to receive, sign, and
return a requisition in the timeframe
needed to respond to the patient’s
urgent clinical status. We had not
anticipated this impact on care when we
finalized our policy.
We also believed that the
administrative burden on physicians
and NPPs would be minimal and would
result in a less confusing process.
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73303
Physicians and NPPs must document
their orders, in some form, in one or
more of the medical records of the
patient. We still believe that signing a
laboratory requisition at the time of the
order, if the requisition is ready for
signature, imposes little burden on the
physician or NPP, while significantly
increasing our ability to minimize
improper payments due to fraud and
abuse. However, we believe we may
have underestimated the number of
occasions in which the physician or
NPP cannot perform both steps
concurrently. We now understand that
it is not always the case that a physician
or NPP can perform both steps
concurrently. For instance, a physician
may sign an order at the time of
delivering care, but the requisition may
not be available for signature until
sometime later. In that situation, the
physician may need to interrupt a
subsequent examination in order to sign
a completed requisition so that the
patient may leave with the requisition.
Given recently released estimates of
physician shortfalls in primary care (for
example, as referenced in remarks by
the Health Resources and Services
Administration (HRSA) Administrator
to the Bureau of Health Professions
Advisory Committee on April 21, 2009),
the cost of lost physician time must also
be revalued upwards. Alternatively, the
beneficiary may have to wait for the
physician or NPP to conclude his or her
subsequent appointment, which could
be as long as 30 minutes or more.
Neither of these situations—interrupting
the physician or NPP in a subsequent
appointment or making the beneficiary
wait for an inconvenient period of
time—is acceptable. Further, we
believed that the policy resulted in a
less confusing process because a
physician or NPP signature would be
required for all requisitions and orders,
eliminating uncertainty over whether
the documentation is a requisition or an
order, whether the type of test being
ordered requires a signature, or which
payment system does or does not
require a physician or NPP signature.
However, based on industry stakeholder
comments subsequent to the publication
of the CY 2011 PFS final rule with
comment period, we now believe this
process may not be less confusing.
Further, industry stakeholders assured
us that they had not been confused
about the former physician/NPP
signature policy and that they never
intended for us to interpret their call for
consistency in the signature process to
mean that they should be burdened with
an additional requirement when they
were already signing the medical record.
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In addition, we believed that many
stakeholders either had converted or
were in the process of converting to an
electronic health records process that
would negate the need for a requisition.
Electronic health records and electronic
transmission of health information are
key pieces of this Administration’s
economic recovery plan and, moreover,
are key elements of our plan to improve
healthcare quality and efficiency. From
the additional stakeholder concerns
subsequent to our CY 2011 PFS final
rule with comment period, we are
sensitive to the increasing migration of
information transfer away from paper
forms, such as requisitions, to the direct
electronic submission of requests for
services. After we adopted the new
policy, stakeholders expressed their
concerns that the requirement for a
signature would increase paperwork, in
direct opposition to our promotion of
time-saving electronic communications.
We believe that the requirement for a
signature on the requisition does not
impact stakeholders who utilize an
electronic process for ordering clinical
diagnostic laboratory tests because the
policy only applies to requisitions,
which are paper forms. Our intent was
not to suggest that a requisition was
necessary in those cases. However, we
recognize that members of the provider
and supplier community still believe
this regulation could inhibit their use of
innovative technology and investment
in healthcare IT resources. Therefore,
we recognize that we underestimated
the potential for paperwork burden.
Finally, we believed that the policy
would make it easier for a reference
laboratory to know whether a test is
appropriately requested and to
minimize potential compliance
problems. Specifically, we believed that
the policy would improve a laboratory’s
ability to authenticate requisitions.
However, based on industry stakeholder
concerns received after the CY 2011 PFS
final rule with comment period and
comments submitted on the CY 2011
PFS proposed rule (75 FR 40161
through 40163), we now believe this
aspect of the policy is less financially
beneficial than we had estimated,
because the percentage of laboratory
requests covered by the policy may be
smaller than we predicted and may
continue to shrink as new technology is
adopted. We also believed the policy
provided a mechanism for laboratories
to fulfill their responsibility to ensure
that they only provide and bill for
services on the direct order of a
physician or NPP because the signature
on the requisition would provide
documentation and evidence that the
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physician or NPP had ordered the
service. However, industry stakeholders
expanded on comments to the CY 2011
PFS proposed rule and informed us that
there was a cost to adopting a rigid
mechanism of establishing authenticity.
Laboratories believe it is more efficient
for them to use internal procedures and
controls to ensure that they do not
provide and bill for services without a
physician authorization rather than
through a Federal policy. Thus, we
believe the expected benefits of the
policy may be less than we originally
estimated.
In summary, there were many
situations that we did not recognize as
problematic until we finalized the
requisition signature policy and
stakeholders began to implement it.
Upon review of the concerns that
industry stakeholders raised after we
finalized our policy in the CY 2011 PFS
final rule with comment period, and in
reconsideration of comments to the CY
2011 PFS proposed rule, we proposed to
retract the policy that was finalized in
the CY 2011 PFS final rule with
comment period, which required a
physician’s or NPP’s signature on a
requisition for clinical diagnostic
laboratory tests paid under the CLFS (75
FR 73483). We proposed to reinstate our
prior policy that the signature of the
physician or NPP is not required on a
requisition for a clinical diagnostic
laboratory test paid under the CLFS for
Medicare purposes.
We remain concerned about the costs
and impact of fraud and abuse on the
Medicare program. The requirement that
the treating physician or NPP must
document the ordering of the test
remains, as does our longstanding
policy that requires orders, including
those for clinical diagnostic laboratory
tests, to be signed by the ordering
physician or NPP. We believe that all
parties share in the responsibility of
ensuring that Medicare services are
provided only in accordance with all
applicable statutes and regulations, such
as the requirement for a physician or
NPP order. In many instances, such as
in the case of orders originating in
hospitals, we believe that retaining all
the other requirements previously
discussed, especially requiring the
physician or NPP who orders the service
to maintain documentation of medical
necessity in the beneficiary’s medical
record according to § 410.32(d)(2)(i), as
well as the hospital CoPs on medical
record services at § 482.24, are
sufficient. However, we note that
hospital CoPs do not apply to other
settings, such as private offices.
We believe it is the responsibility of
the clinical diagnostic laboratory, as it is
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for the provider of any service, to have
sufficient processes and safeguards in
place to ensure that all services are
delivered only when ordered by a
physician or NPP. This proposed rule
does not preclude an individual
laboratory from requiring a physician’s
or NPP’s signature on the requisition.
The laboratory may develop its own
compliance procedures to ensure that it
only furnishes services in response to a
physician or NPP order. Such
procedures could include internal
audits, agreements with ordering
physicians or NPPs to provide medical
record evidence of the order in the event
of an internal or external audit, steps to
confirm the existence of an order under
certain circumstances, or any other
measures including the acceptance of
risk by the clinical laboratory. We
believe this financial and compliance
responsibility was implicit in the 2001
final rule (66 FR 58788), was reiterated
in the March 5, 2002 transmittal
(Change Request 2410, Transmittal AB–
02–030), and has remained a consistent
element of the subsequent instructions.
Comment: All commenters supported
CMS’s proposal to retract the policy
requiring a physician’s or NPP’s
signature on a requisition for clinical
diagnostic laboratory tests paid under
the CLFS, which was finalized in the CY
2011 PFS final rule with comment
period. All commenters also supported
the proposal to reinstate the prior policy
that the signature of the physician or
NPP is not required on a requisition for
a clinical diagnostic laboratory test paid
under the CLFS for Medicare purposes.
Response: We thank the commenters
for their support and, as discussed
below, are finalizing our proposal
without modification.
After consideration of the public
comments received, we are finalizing
our proposal to retract the policy that
was finalized in the CY 2011 PFS final
rule with comment period, which
required a physician’s or NPP’s
signature on a requisition for clinical
diagnostic laboratory tests paid under
the CLFS (75 FR 73483) and to reinstate
our prior policy that the signature of the
physician or NPP is not required on a
requisition for a clinical diagnostic
laboratory test paid under the CLFS for
Medicare purposes.
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E. Section 4103 of the Affordable Care
Act: Medicare Coverage and Payment of
the Annual Wellness Visit Providing a
Personalized Prevention Plan Under
Medicare Part B
1. Incorporation of a Health Risk
Assessment as Part of the Annual
Wellness Visit
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a. Background and Statutory
Authority—Medicare Part B Coverage of
an Annual Wellness Visit Providing
Personalized Prevention Plan Services
Preventive care and beneficiary
wellness are important to the Medicare
program and have become an increasing
priority. In section 4103 of the
Affordable Care Act, the Congress
expanded Medicare Part B benefits to
include an annual wellness visit
providing personalized prevention plan
services (hereinafter referred to as an
annual wellness visit). The annual
wellness visit is described more fully in
section 1861(hhh) of the Act, and
coverage was effective for services
furnished on or after January 1, 2011.
Regulations for Medicare coverage of the
annual wellness visit are established at
42 CFR 410.15. The annual wellness
visit may be performed by a physician,
nonphysician practitioner (physician
assistant, nurse practitioner, or clinical
nurse specialist), or a medical
professional (including a health
educator, a registered dietitian, or a
nutrition professional, or other licensed
practitioner) or a team of such medical
professionals, working under the direct
supervision of a physician. In summary,
for CY 2011, the first annual wellness
visit includes—
• Establishment of an individual’s
medical and family history;
• Establishment of a list of current
medical providers and suppliers
involved in providing medical care to
the individual;
• Measurement of an individual’s
height, weight, body mass index (or
waist circumference, if appropriate),
blood pressure, and other routine
measurements as deemed appropriate,
based on the beneficiary’s medical and
family history;
• Detection of any cognitive
impairment that the individual may
have;
• Review of the individual’s potential
(risk factors) for depression;
• Review of the individual’s
functional ability and level of safety;
• Establishment of a written
screening schedule for the individual
such as a checklist for the next 5 to 10
years, as appropriate, based on
recommendations of the United States
Preventive Services Task Force, the
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Advisory Committee on Immunization
Practices, and the individual’s health
status, screening history, and ageappropriate preventive services covered
by Medicare;
• Establishment of a list of risk factors
for which primary, secondary or tertiary
interventions are recommended or
underway for the individual, including
any mental health conditions or any
such risk factors or conditions that have
been identified through an initial
preventive physical examination (IPPE),
and a list of treatment options and their
associated risks and benefits;
• Furnishing of personalized health
advice to the individual and referrals, as
appropriate, to health education or
preventive counseling services or
programs aimed at reducing identified
risk factors and improving selfmanagement; and
• Any other element determined
appropriate through the national
coverage determination process (NCD).
In summary, for CY 2011, subsequent
annual wellness visits include—
• An update of the individual’s
medical and family history;
• An update of the list of current
providers and suppliers that are
regularly involved in providing medical
care to the individual;
• Measurement of an individual’s
weight (or waist circumference), blood
pressure and other routine
measurements as deemed appropriate,
based on the individual’s medical and
family history;
• Detection of any cognitive
impairment that the individual may
have;
• An update to the written screening
schedule for the individual;
• An update to the list of risk factors
and conditions for which primary,
secondary, or tertiary interventions are
recommended or are underway for the
individual;
• Furnishing of personalized health
advice to the individual and referrals, as
appropriate, to health education or
preventive counseling services;
• Any other element determined
appropriate through the NCD process.
The annual wellness visit is
specifically designed as a wellness visit
that focuses on identification of certain
risk factors, personalized health advice,
and referral for additional preventive
services and lifestyle interventions
(which may or may not be covered by
Medicare). The elements included in the
annual wellness visit differ from
comprehensive physical examination
protocols with which some providers
may be familiar since the annual
wellness visit is a visit that is
specifically designed to provide
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personalized prevention plan services as
defined in the Act.
Section 1861(hhh)(1)(A) of the Act
specifies that a personalized prevention
plan for an individual includes a health
risk assessment (HRA) that meets the
guidelines established by the Secretary.
In general, an HRA is an evaluation tool
designed to provide a systematic
approach to obtaining accurate
information about the patient’s health
status, injury risks, modifiable risk
factors, and urgent health needs. This
evaluation tool is completed prior to, or
as part of, an annual wellness visit. The
information from the HRA is reflected in
the personalized prevention plan that is
created for the individual.
Although the annual wellness visit
was effective on January 1, 2011, section
4103 of the Affordable Care Act
provided the Secretary additional time
to establish guidelines for HRAs after
consulting with relevant groups and
entities (see section 1861(hhh)(4)(A) of
the Act). A technology assessment from
the Agency for Healthcare Research and
Quality (AHRQ) was commissioned to
describe key features of HRAs, to
examine which features were associated
with successful HRAs, and to discuss
the applicability of HRAs to the
Medicare population. The finalized
technology assessment was posted on
July 6, 2011 and is publicly available on
the CMS Web site at https://
www.cms.gov/determinationprocess/
downloads/id79ta.pdf.
We collaborated with the Centers for
Disease Control and Prevention (CDC),
due to their in-depth knowledge of
HRAs, and because the CDC was
directed by section 4004(f) of the
Affordable Care Act to develop
guidelines for a personalized prevention
plan tool. In the November 16, 2010
Federal Register (75 FR 70009), CDC
issued a notice to solicit feedback
regarding HRA guidance development.
Public comments were received from
numerous relevant groups and entities
including: The American Academy of
Family Physicians, the American
Dietetic Association, the American
Geriatrics Society, the American College
of Cardiology, Care Continuum
Alliance, physician practices, public
health agencies, healthcare research
groups, and the general public.
The CDC convened a public meeting
in Atlanta, Georgia in February 2011 to
facilitate the development of guidance
for HRAs. (See the December 30, 2010
Federal Register (75 FR 82400)—
announcement for ‘‘Development of
Health Risk Assessment Guidance,
Public Forum’’). This meeting allowed
broad public input from stakeholders
and the general public into the
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development of guidelines for evidencebased HRAs. The Interim Guidance for
Health Risk Assessments developed by
the CDC is available on the CMS Web
site at https://www.cms.gov/
coveragegeninfo/downloads/
healthriskassessmentsCDCfinal.pdf. The
CDC guidance resulted from a
compilation and review of the current
scientific evidence, the AHRQ
technology assessment, and expert
advice from those working in the field
of HRA and wellness, and takes into
account public feedback from the
request for information and the public
meeting. The CDC guidance includes
questions and topics to be addressed as
deemed appropriate for the beneficiary’s
age. Additional information regarding
the CDC guidance development process
is included as part of the guidance
document. The CDC plans to publish ‘‘A
Framework for Patient-Centered Health
Assessments, a Morbidity and Mortality
Weekly Report (MMWR).’’ The MMWR
will include additional information
applicable to the successful
implementation of the HRA, such as the
CDC interim guidance document, as
well as information related to
implementation, feedback, and followup that evidence suggests is critical for
improving health outcomes using this
process. We look forward to
stakeholders engaging in the
development of innovative tools or
methods, which would provide health
professionals the flexibility to adapt the
HRA guidance to evaluate additional
topics, as appropriate, to provide a
foundation for development of a
personalized prevention plan as part of
the annual wellness visit. We also look
forward to stakeholders engaging in the
development of innovative electronic
solutions for conducting a HRA and
integration with electronic health
records.
b. Implementation—Summary of
Proposed Rule and Comments
Consistent with section 1861(hhh) of
the Act and the initial CDC guidance
document, we proposed to amend 42
CFR 410.15 by: (1) Adding the term
‘‘health risk assessment’’ and its
definition; (2) revising the definitions of
‘‘first annual wellness visit providing
personalized prevention plan services’’
and ‘‘subsequent annual wellness visit
providing personalized prevention plan
services;’’ and (3) incorporating the use
and results of an HRA into the provision
of personalized prevention plan services
during the annual wellness visit.
The following is a summary of the
provisions of the proposed rule and the
comments received. We received 59
public comments from national and
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State professional associations, national
medical advisory and patient advocacy
groups, health insurance associations,
health care systems, manufacturers, a
government agency, and other national
healthcare organizations. Thirty-two
(32) comments supported incorporation
of an HRA into the annual wellness visit
and 5 were opposed. The remaining 22
comments provided feedback about the
impact of the annual wellness visit as a
whole requested modifications or
additional elements to the annual
wellness visit, and coverage for
additional preventive services and
vaccines.
Most supporters generally agreed with
the proposed major HRA components.
One commenter indicated that the
inclusion of the HRA would help make
care more preventive and proactive, and
help avoid long-term maladies
associated with aging and chronic
diseases. Some commenters expressed
concern that the proposal was too
prescriptive and did not allow for
sufficient flexibility. Other commenters
were concerned that the HRA
components were not sufficiently
targeted to specific diseases. One
commenter was of the opinion that there
was a lack of evidence for the usefulness
of an HRA, and believed the best
evidence on the efficacy of
comprehensive health risk assessment
for the elderly comes from highly
specialized geriatric assessment clinics
capable of targeting individuals at high
risk and providing longitudinal followup. This commenter believed that it
would be impossible to replicate similar
interventions without follow-up visits,
and indicated that additional research is
needed to determine how an HRA can
be effectively translated into primary
care practice.
Regarding flexibility of the HRA,
some commenters supported a more
flexible approach to HRA development
and use, while others requested that a
standardized tool be developed and
certified by either CMS or an outside
accrediting organization. A few
commenters believed the HRA would be
difficult for health professionals to
implement since the CDC guidance had
not been published and work had not
been completed on establishing
standards for interactive web-based
programs to furnish HRAs, referencing
other components of section 4103 of the
Affordable Care Act.
In the proposed rule, we requested
public comment on the overall impact
and burden of the annual wellness visit
on health professional practices,
including the impact that incorporation
and use of an HRA would have on
health professionals and their practices.
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Two commenters believed that the
incorporation of an HRA supports a
systematic approach to patient wellness,
providing a foundation for development
of a personalized prevention plan and
they supported the inclusion of a
minimum set of topics as part of the
HRA. Four commenters indicated that
the use of an HRA would have a
significant impact on health
professional practices. One commenter
stated that inclusion of an HRA would
be somewhat or very difficult. Another
was concerned that health professionals
would be penalized if an individual
refuses to complete an HRA or follow
the personalized prevention plan
recommendations. Another commenter
was concerned with the lack of a
publicly available HRA.
Of those commenters that provided
feedback on the potential burden of the
HRA as part of both first and subsequent
AWVs on health professional practices,
the comments ranged from requesting
that HRAs be optional and used at the
discretion of a health professional, to
requesting that the CDC develop a
standardized HRA tool for use with the
Medicare aged population. One
commenter opined that a quality HRA
will provide health professionals
information that shows patient progress
over time without adding additional
effort on the practitioner. This same
commenter also believed that HRAs
could have a positive impact on health
professional practices by helping
patients understand their health care
needs. Three commenters indicated that
development and implementation of an
HRA that meets CDC guidelines could
be a significant burden. One commenter
recommended that the HRA
implementation date be extended to July
1, 2012. Three comments expressed
concern with what they believed to be
a rigid approach that would require
questions for all Medicare beneficiaries
in conjunction with prevention plan
services that they believed would not be
applicable for every beneficiary on an
annual basis.
(1) Definition of a ‘‘Health Risk
Assessment’’
We proposed to revise § 410.15 by
adding the term ‘‘health risk
assessment’’ and defining such term as
an evaluation tool that meets the
following requirements:
• Collects self-reported information
about the beneficiary.
• Can be administered independently
by the beneficiary or administered by a
health professional prior to or as part of
the AWV encounter.
• Is appropriately tailored to and
takes into account the communication
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needs of underserved populations,
persons with limited English
proficiency, and persons with health
literacy needs.
• Takes no more than 20 minutes to
complete.
• Addresses, at a minimum, the
following topics:
++ Demographic data, including but
not limited to age, gender, race, and
ethnicity.
++ Self assessment of health status,
frailty, and physical functioning.
++ Psychosocial risks, including but
not limited to depression/life
satisfaction, stress, anger, loneliness/
social isolation, pain, or fatigue.
++ Behavioral risks, including but
not limited to tobacco use, physical
activity, nutrition and oral health,
alcohol consumption, sexual practices,
motor vehicle safety (seat belt use), and
home safety.
++ Activities of daily living (ADLs),
including but not limited to dressing,
feeding, toileting, grooming, physical
ambulation (including balance/risk of
falls), and bathing.
++ Instrumental activities of daily
living (IADLs), including but not limited
to shopping, food preparation, using the
telephone, housekeeping, laundry,
mode of transportation, responsibility
for own medications, and ability to
handle finances.
The standards outlined in the
definition of the term health risk
assessment represent a minimum set of
topics that need to be addressed as part
of an HRA, while allowing the health
professional the flexibility to evaluate
additional topics, as appropriate, to
provide a foundation for development of
a personalized prevention plan.
Comment: Commenters requested
flexibility regarding the elements
included in the HRA and/or the time
allotted for administration. Four
comments indicated that the amount of
time allotted for HRA administration
was not adequate, given the number of
HRA components.
Response: We believe it is important
to balance the comprehensiveness of the
HRA with the potential burden on
patients and health professional time
constraints. The elements included in
the HRA definition are those that
experts in the field of HRAs advised are
scientifically valid and for which there
is evidence of effectiveness. In a study
on HRA design, Mills and colleagues
reported that there was a ‘‘significant
drop-off in completion after 20 minutes
of engagement’’ (Mills et al. J R Soc Med
Sh Rep 2011;2:71. DOI 10.1258/
shorts.2011.011015). We believe that the
components of the HRA that we
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proposed could be completed by most
patients within 20 minutes.
Comment: One commenter believes
that information related to elements of
the annual wellness visit could be
collected efficiently through the HRA,
such as family history, screening
history, a list of providers and suppliers
regularly involved in the individual’s
care, and current medications. Another
commenter suggested that the HRA
collect information about patient access
to preventive services, including history
of appropriate vaccinations.
Response: We recognize that medical
and family history (including current
medications) and preventive services
utilization history are important
components of the annual wellness visit
and for inclusion in the patient’s
medical record. While we agree that
these topics are important components
in the provision of personalized
prevention plan services, we believe it
is important to balance the
comprehensiveness of the HRA with the
potential burden on patients and health
professional time constraints. Medical
and family history (as defined in
§ 410.15(a)) and development or update
of the list of providers and suppliers
that are involved in the patient’s care
are typically asked and reviewed by the
health professional during the AWV
encounter. Thus, we are not adopting
the commenter’s suggestions to add
these topics as mandatory components
of the HRA.
Comment: A few commenters
requested that CMS include falls
screening in the HRA. One commenter
believes that fall risk assessments
should be consistent with the clinical
practice guidelines established by major
geriatric societies, which include
recommendations for screening with
further assessment and referral as
indicated. Another commenter
requested that functional status data be
collected through the HRA to enhance
the fall risk assessment during the
annual wellness visit.
Response: While we appreciate the
suggestions offered by the commenters,
the HRA is not meant to replace the
patient and family history that is
usually asked and reviewed by the
health professional, but rather to be an
adjunct to it, providing information on
behaviors known only to the patient. It
has been determined by medical
providers and other experts in the field
of HRA that risk for falls (for example,
impaired balance) can best be assessed
in a face-to-face encounter with a health
professional. We note that a review of
the beneficiary’s level of safety is
already required as part of the first
annual wellness visit. Self assessment of
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73307
health status, frailty, and physical
functioning, along with physical activity
and seat belt use (which is assessed as
a safety measure), were included in the
proposed definition of an HRA, which
will be updated at each subsequent
annual wellness visit. Discussion of
these topics opens the possibility of
additional provider inquiry in assessing
other safety risks. Thus, we are not
adopting the commenter’s suggestion to
add more detailed information about fall
risk to the HRA.
Comment: One commenter supported
the emphasis on the beneficiary’s role in
completing the HRA and suggested that
we expand upon this effort to further
engage patients in the AWV and the
provision of personalized prevention
plan services by adding patient goals for
health and wellness as components of
the HRA.
Response: Patient goals are identified
through the process of shared decisionmaking where the health professional
works with the patient to discover what
is important to the patient and the
patient’s motivation to change behavior,
as part of the provision of personalized
prevention plan services during the
annual wellness visit encounter. Thus,
we are not adopting the commenter’s
suggestions to add patient goals as a
component of the HRA.
Comment: Other commenters
requested that the HRA incorporate the
collection of more detailed nutrition
data and data that may help health
professionals assess risk for diabetes,
heart disease, and cancer.
Response: Questions related to
nutrition and hypertension were
included in the proposed HRA
definition. A more detailed nutrition
assessment could be conducted by the
provider if answers to the HRA
questions indicate an issue with
nutrition. Cancer risk can be identified
through a complete patient history. As
discussed in a previous response, the
HRA is not meant to replace the patient
and family history that is usually asked
and reviewed by the health professional,
but rather to be an adjunct to it,
providing information on behaviors
known only to the patient. Adding
additional mandatory information as
part of the HRA would increase the time
it takes to complete the HRA, and we
are mindful that adding too much
information could be burdensome to
patients. Thus, we are not mandating a
more detailed nutritional assessment in
the HRA.
Comment: A few commenters
suggested that the HRA include tobacco
use questions, collect information about
tobacco use screening, and utilization of
tobacco use cessation counseling. One
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commenter requested that counseling
for tobacco use cessation be included as
part of subsequent annual wellness
visits.
Response: We note that the definition
of an HRA includes among other things,
behavioral risks such as tobacco use. We
agree that tobacco use cessation
counseling is important for those
individuals that use tobacco products. If
positive tobacco use is identified during
the annual wellness visit, additional
questions can be asked by the health
professional followed by the process of
motivational interviewing (the health
professional offers personalized
information to the patient) and shared
decision-making (the health
professional works with the patient to
discover what is important to the
patient and the patient’s motivation to
change behavior) in the development of
the personalized prevention plan during
the annual wellness visit encounter.
In § 410.15(a), we defined first and
subsequent annual wellness visits to
include provisions for the furnishing of
personalized health advice and referrals,
as appropriate, to health education or
preventive counseling services,
including among other things, tobacco
use cessation. We note that Medicare
covers counseling to prevent tobacco
use as an ‘‘additional preventive
service’’ under Medicare Part B
(additional information available in
Pub. 100–03, Medicare National
Coverage Determinations Manual,
Chapter 1, Section 210.4.1). We believe
that the health professionals who are
furnishing the annual wellness visits,
whether they are first or subsequent
annual wellness visits, will establish or
update an appropriate list of referrals for
education services and preventive
counseling services for each individual.
Comment: One commenter supported
and appreciated the recognition of the
importance of behavioral risks as part of
the HRA. However, the commenter
suggested that ‘‘sexual practices’’ be
replaced with a term that would provide
a more comprehensive view of the
individual’s mental and physical health,
such as ‘‘sexual health.’’
Response: We agree with the
comment and are changing the language
in the final rule. Specifically, we are
modifying paragraph (v)(D) of the
definition of the term ‘‘health risk
assessment’’ to read ‘‘Behavioral risks,
including but not limited to, tobacco
use, physical activity, nutrition and oral
health, alcohol consumption, sexual
health, motor vehicle safety (seat belt
use), and home safety.’’
Comment: Many commenters were of
the opinion that memory should be
included in the HRA. One commenter
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agreed with the provisions of the
proposed rule that did not include
cognitive assessment as part of the HRA,
however, the commenter believed that
general questions about memory should
be included in the HRA. Other
commenters were concerned that an
appropriate screening instrument for
cognitive impairment was not included
in either the HRA or annual wellness
visit, and requested modifications to the
definition of ‘‘detection of any cognitive
impairment’’ to include use of an
appropriate screening instrument.
Response: We agree with commenters
that detection of cognitive impairment
is important. We note that ‘‘detection of
any cognitive impairment’’ is already
part of the annual wellness visit,
consistent with the statutory elements
described in section 1861(hhh)(2) of the
Act. As Boustani and colleagues (Ann
Internal Medicine 2003;138:927–937)
noted: ‘‘Dementia causes a high burden
of suffering for patients, their families,
and society. For patients, it leads to
increased dependency and complicates
other comorbid conditions. For families,
it leads to anxiety, depression, and
increased time spent caring for a loved
one. The annual societal cost of
dementia is approximately $100 billion
(health care and related costs as well as
lost wages for patients and family
caregivers).’’ Because information
related to cognitive impairment is
already addressed as part of the annual
wellness visit, we do not believe it is
necessary to duplicate the collection of
this information through the HRA.
We also note that an evidence-based,
standardized screening tool for
dementia is not currently available for
assessment of cognitive impairments.
The USPSTF noted: ‘‘[M]ost screening
tests have been evaluated in studies
with small sample sizes, and the
populations of patients on whom
screening instruments have been tested
have varied greatly, making it difficult
to determine the overall performance of
screening tests for dementia’’ (https://
www.uspreventiveservicestaskforce.org/
3rduspstf/dementia/dementrr.pdf).
Since there is no nationally recognized
screening tool for the detection of
cognitive impairments at the present
time, we are not making any changes to
the definition of ‘‘detection of any
cognitive impairment’’ at this time. We
believe that physicians can use their
best clinical judgment in the detection
and diagnosis of cognitive impairments,
along with determining whether
additional resources may need to be
used in the course of screening and
treatment of the patient.
We appreciate the interest in the
identification and development of an
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appropriate cognitive screening
instrument. We are collaborating with
the National Institute on Aging, the
Department of Veterans Affairs, CDC,
AHRQ, and other relevant stakeholders
to assess the current methods for
detecting cognitive impairment to
develop recommendations for health
professionals with respect to
appropriate responses to both positive
and negative cognitive impairment
assessment results. We will continue to
monitor advancements in screening,
collaborate with the USPSTF, and will
consider revising this element if the
evidence is sufficient and a
standardized screening test becomes
available. Thus, at this time, we are not
adopting the suggestion to include
additional mandatory components
related to memory or cognitive
assessment within the HRA.
Comment: Two comments supported
inclusion of history of alcohol
consumption in the HRA, but
recommended that we add substance or
drug use history to the HRA. One
commenter indicated that illicit
substance use and prescription drug
misuse are significant concerns among
older adults. Another commenter
indicated that intravenous drug use is a
risk factor for HIV transmission.
Response: We are not adopting the
commenters’ suggestions to include
these topics as mandatory components
in the HRA to reflect a history of drug
use. Other components included in the
HRA definition, such as those
pertaining to alcohol consumption,
provide an opportunity for health
professionals to ask additional questions
related to additional areas of potential
substance use, including prescription
drug misuse and illicit drug use.
(2) Changes to the Definitions of ‘‘First
Annual Wellness Visit’’ and
‘‘Subsequent Annual Wellness Visit’’
In § 410.15, we adopted the
components of the annual wellness
visit, consistent with the statutory
elements described in section
1861(hhh)(2) of the Act. The first and
subsequent annual wellness visits, as
defined in § 410.15(a), are meant to
represent a beneficiary visit focused on
prevention. Among other things, the
annual wellness visit encourages
beneficiaries to obtain the preventive
services covered by Medicare that are
appropriate for them. First and
subsequent annual wellness visits also
include elements that focus on the
furnishing of personalized health advice
and referral, as appropriate, to health
education, preventive counseling
services, programs aimed at improving
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self-management, and community-based
lifestyle interventions.
We proposed to revise the definitions
for first and subsequent annual wellness
visits to incorporate the use and results
of an HRA in the provision of
personalized prevention plan services
during the annual wellness visit. The
HRA is integral to the provision of
personalized prevention plan services,
consistent with section 1861(hhh) of the
Act. We proposed to incorporate the
HRA by revising the definitions for first
and subsequent annual wellness visits
as follows—
• Specify that the annual wellness
visit take into account the results of an
HRA;
• Add the review (and
administration, if needed) of an HRA as
an element of both first and subsequent
annual wellness visits; and
• Specify that the establishment of a
written screening schedule for the
individual, such as a checklist, includes
and takes into account the HRA.
The HRA facilitates a systematic
method for identifying health behaviors
and risk factors known to the patient
(for example: tobacco use, physical
activity, and nutritional habits) for
which the medical provider can discuss
and provide tailored feedback aimed at
reducing risk factors as well as reducing
the potential for developing the diseases
to which they are related.
During the annual wellness visit
encounter, the HRA information is
utilized by the health professional in a
thought process intended to develop a
personalized prevention plan for the
patient to improve health status and
delay the onset of disease. For instance,
if the information provided by the HRA
indicated that the beneficiary had a
current or past history of tobacco use,
the health professional may deem it
appropriate to perform those commonly
used aspects of a clinical evaluation (for
instance, listening to (auscultation) the
heart and lungs) in order to provide the
appropriate personalized health advice
and referrals for additional preventive
services such as tobacco use cessation
counseling.
We believe that the incorporation of
the HRA will increase the efficiency of
the health professional’s effort during
the annual wellness visit. For instance,
during the annual wellness visit
encounter, the health professional
furnishing the annual wellness visit
would review the information reported
in the HRA, which would serve as the
basis for a personalized prevention plan
provided during the annual wellness
visit encounter. The beneficiary would
leave the visit with personalized health
advice, appropriate referrals, and a
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written individualized screening
schedule, such as a check list. We
would not expect that the health
professional would provide only general
recommendations during the annual
wellness visit encounter and then mail
a personalized prevention plan that
incorporates an HRA to the beneficiary
outside of the annual wellness visit
encounter. While the annual wellness
visit is a wellness visit that focuses on
wellness and disease prevention, a
follow-up visit to treat an identified
illness may be needed to address an
urgent health issue. For example, if a
beneficiary is determined to have high
blood pressure, a follow- up visit for
further review of symptoms and
evaluation and management, along with
determining whether additional
interventions are necessary, may be
performed after the completion of the
annual wellness visit as a separate
service.
We also proposed changes to the
definition of the term ‘‘subsequent
annual wellness visit providing
personalized prevention plan services’’
to clarify that the health professional
should furnish personalized prevention
plan services and updated information
if there have been changes since the
beneficiary’s last annual wellness visit,
whether that was a first annual wellness
visit or a subsequent annual wellness
visit. In the CY 2011 PFS final rule, we
stated in the definition for subsequent
annual wellness visits that certain
elements should be updated based on
information developed during the first
annual wellness visit (for example, lists
of risk factors and screening schedules).
Since all annual wellness visits that
follow the first annual wellness visit are
considered subsequent annual wellness
visits, the health professional should
update elements that were developed
during the previous annual wellness
visit if there have been changes. We
received one comment regarding the
proposed changes to update elements of
the annual wellness visit developed
during the previous annual wellness
visit. The commenter agreed with the
proposed changes. The proposed
changes to the definition for subsequent
annual wellness visits, which we are
finalizing in this final rule with
comment period are as follows:
• Newly redesignated paragraph (iii)
states ‘‘an update of the list of current
providers and suppliers that are
regularly involved in providing medical
care to the individual as that list was
developed for the first annual wellness
visit providing personalized prevention
plan services or the previous subsequent
annual wellness visit providing
personalized prevention plan services’’.
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73309
• Newly redesignated paragraph
(vi)(B), states ‘‘the list of risk factors and
conditions for which primary,
secondary or tertiary interventions are
recommended or are underway for the
individual as that list was developed at
the first annual wellness visit providing
personalized prevention plan services or
the previous subsequent annual
wellness visit providing personalized
prevention plan services’’.
Comment: A few comments requested
that the annual wellness visit and HRA
be treated as a combined approach to
satisfy the elements that comprise
personalized prevention plan services.
One commenter was of the opinion that
the HRA only addresses two of the
annual wellness visit components:
potential risk factors for depression, and
functional ability and level of safety.
This same commenter believes that the
HRA should not be considered another
component of the annual wellness visit,
but rather the mechanism that helps
drive the content of the office visit and
the provision of personalized
prevention plan services. Another
commenter expressed concerns about
whether an annual wellness visit would
be covered by Medicare Part B if a
beneficiary declined to fill out or
complete an HRA.
Response: We agree with the
commenters that an HRA is an
important part of the annual wellness
visit. We do not agree that the HRA
must reflect all of the elements of the
annual wellness visit, as this approach
would be unduly duplicative and also
burdensome to patients completing the
HRA. As we discussed in the proposed
rule, we believe that incorporation of
the HRA supports a systematic approach
to patient wellness and is integral to the
furnishing of personalized prevention
plan services during the annual
wellness visit. The results of the HRA
will facilitate and provide the
foundation for the development of the
personalized prevention plan. Thus, we
are not making additional changes in
response to these comments. While the
statute requires that the HRA be
included, and taken into account in the
provision of personalized prevention
plan services as part of the annual
wellness visit, the statute and this rule
do not speak to how a health
professional should address items left
blank. We expect that health
professionals will act in good faith to
assist beneficiaries to complete the
items relevant to the development of a
personalized prevention plan.
In the proposed rule, we included
language that specified that first and
subsequent annual wellness visits
providing personalized prevention plan
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services take into account the results of
a HRA. In response to the comments
received, we are modifying the
introductory text of the definition of the
term ‘‘first annual wellness visit
providing personalized prevention plan
services’’ to specify that the first AWV
includes and takes into account the
results of an HRA, consistent with
section 1861(hhh)(1) of the Act. We
continue to believe that review (and
administration, if needed) of the HRA
are also integral pieces of the provision
of personalized prevention plan
services. Therefore, we are finalizing the
addition of new paragraph (i) ‘‘review
(and administration, if needed) of a
health risk assessment’’ to the definition
of the term ‘‘first annual wellness visit
providing personalized prevention plan
services.’’
Comment: A few commenters
expressed concern with what they
believed to be a rigid approach that
would require questions for all
Medicare beneficiaries in conjunction
with prevention plan services that they
believed would not be applicable for
every beneficiary on an annual basis.
Response: We agree with the
commenters that a patient may not need
to complete a full HRA if he or she
obtains an annual wellness visit every
year as permitted by the statute, but
update the HRA. Therefore, we are
modifying the introductory text and
new paragraph (i) of the definition of
the term ‘‘subsequent annual wellness
visit providing personalized prevention
plan services’’ to specify that the HRA
be updated as part of subsequent visits.
These changes will reduce the burden
for both patients and health
professionals while ensuring that the
HRA is updated to reflect relevant
changes.
Comment: Many commenters
provided suggestions regarding
administration of the HRA, specifically
requesting that CMS allow a physician’s
office to mail the HRA to the beneficiary
prior to the appointment or administer
the HRA over the phone. Commenters
asked for clarification about the staff
that would be appropriate to administer
the HRA.
One commenter suggested a hierarchy
of preferred administration methods,
starting with internet-based systems,
kiosk-style systems, automated
telephone response systems, and paperbased mail-in systems. However, the
same commenter, along with several
others, opined that the paper-based
system may be the most appropriate for
Medicare beneficiaries. Commenters
believed that beneficiaries may not be
comfortable with or use the internet for
health information.
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Response: As we stated in the
proposed rule, we believe that the
health professional should consider the
beneficiary’s needs when determining
whether assistance would be needed for
the beneficiary to complete the HRA,
including whether administrative
support by health professionals is
necessary. We believe it is important
that health professionals have the
flexibility to address additional topics
as appropriate, based on patient needs,
consistent with our final rule. Thus,
there is not only one type of HRA that
will meet the CDC guidelines.
While we appreciate the commenters’
concerns, we are not assigning
particular tasks or restrictions for
specific members of the team in this
final rule. We believe it is better for the
supervising physician to assign specific
tasks to qualified team members (as long
as they are licensed in the State and
working within their State scope of
practice). This approach gives the
physician and the team the flexibility
needed to address the beneficiary’s
particular needs on a particular day.
As we discussed in the proposed rule,
the CDC plans to publish ‘‘A Framework
for Patient-Centered Health
Assessments, a Morbidity and Mortality
Weekly Report (MMWR).’’ The MMWR
will include additional information
applicable for the successful
implementation of the HRA, such as the
CDC interim guidance document, as
well as information related to
implementation, feedback, and followup that evidence suggests is critical for
improving health outcomes using this
process.
Comment: Some comments
recommended that CMS identify HRA
tools that meet the criteria outlined in
the proposed rule and also provide for
an accreditation or certification process
for HRA instruments.
Response: We believe it is important
that health professionals have the
flexibility to address additional topics
as appropriate, based on patient needs,
consistent with our final rule. Thus,
there is not only one type of HRA that
will meet the CDC guidelines.
As we discussed in the proposed rule,
the CDC plans to publish ‘‘A Framework
for Patient-Centered Health
Assessments, a Morbidity and Mortality
Weekly Report (MMWR).’’ The MMWR
will include additional information
applicable for the successful
implementation of the HRA, such as the
CDC interim guidance document, as
well as information related to
implementation, feedback, and followup that evidence suggests is critical for
improving health outcomes using this
process. While we are not including
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requirements for accreditation or
certification of HRA instruments in this
final rule, we may consider a
certification process in the future.
We requested comments on the
impact of the elements included in the
definitions of first and subsequent
annual wellness visits and requested
comments on the modification of those
annual wellness visit elements for
which the Secretary has the authority to
determine appropriateness.
Comment: One comment indicated
that the annual wellness visit helped
health professionals address preventive
services in a more organized manner
and believed the annual wellness visit
was being furnished without difficulty.
Another offered support for the
establishment of a written screening
schedule. One commenter believed that
the annual wellness visit provided little
benefit for the patient and created more
burdens for the physician, while
another believed that the annual
wellness visit elements were rigid and
onerous compared to other preventive
services.
Some commenters requested that
CMS include a comprehensive physical
exam as part the annual wellness visit.
Other commenters requested that
additional biometric assessments and
routine blood work also be included as
part of the AWV. One indicated that
furnishing and coding for a separate
physical exam may be confusing for
physicians and deter the provision of
the annual wellness visit. One
commenter said that the physical exam
is necessary to develop an accurate and
appropriate list of risk factors and
conditions for which primary,
secondary, and tertiary interventions are
recommended or are underway. Other
commenters requested that laboratory
tests and blood work should also be
included in the annual wellness visit
since the commenter considers blood
work and laboratory tests standards in
physician practice.
Response: In § 410.15, we adopted the
components of the annual wellness
visit, consistent with the statutory
elements described in section
1861(hhh)(2) of the Act. The first and
subsequent annual wellness visits, as
defined in § 410.15(a), are meant to
represent a beneficiary visit focused on
prevention. The annual wellness visit is
not a ‘‘routine physical check-up’’ that
some beneficiaries may receive
periodically from their physician or
practitioner. The annual wellness visit
is specifically designed as a wellness
visit that focuses on identification of
certain risk factors, personalized health
advice, and referral for additional
preventive services and lifestyle
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interventions (which may or may not be
covered by Medicare). Therefore, we are
not adopting the suggestion to mandate
a comprehensive physical examination
as part of the annual wellness visit.
Regarding requests that routine blood
work be included in the annual
wellness visit, we note that Medicare
Part B already covers the following
screenings that include blood work—
• Cardiovascular disease screenings
once every 5 years (lipid panel,
cholesterol, lipoprotein, and
triglycerides); and
• Diabetes screening tests for
beneficiaries that meet certain
conditions (2 screening tests per year for
beneficiaries diagnosed with prediabetes; 1 screening per year if
previously tested, but not diagnosed
with pre-diabetes, or if never tested).
Given that these are separate Part B
benefits, we are not adding routine
blood work as a component of the
annual wellness visit.
Comment: We received several
comments that supported the
establishment of a written screening
schedule that includes both services
that are covered by Medicare as well as
community-based services that may not
be covered by Medicare. One
commenter stated that coordination
with wellness programs would greatly
enhance the effectiveness of
personalized prevention plan services as
a tool to reduce individual health risks.
Commenters explained that the
discussion of appropriate preventive
services should not be limited based on
insurance coverage. Other commenters
requested that health professionals
consider providing voluntary HIV
screening, and referrals for medical
nutrition therapy, home health services,
and outpatient rehabilitation services.
Regarding mental health services, one
commenter opined that there is a lack of
mental health professionals involved in
primary care and, thus, requested that
CMS add a requirement to the annual
wellness visit for referral to mental
health professionals.
Response: We appreciate the
comments received and agree that it is
important for health professionals that
furnish the annual wellness visit to
include information regarding
appropriate preventive services, based
on the beneficiary’s current risk factors.
That being said, the annual wellness
visit includes the following element:
‘‘furnishing of personalized health
advice to the individual and a referral,
as appropriate, to health education or
preventive counseling services or
programs aimed at reducing identified
risk factors and improving selfmanagement, or community-based
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lifestyle interventions to reduce health
risks and promote self-management and
wellness, including weight loss,
physical activity, smoking cessation, fall
prevention, and nutrition.’’
We believe that the health
professional who is furnishing an
annual wellness visit will determine an
appropriate list of referrals for education
services and preventive counseling
services for each individual as part of
the provision of personalized
prevention plan services. We believe
that the definitions for first and
subsequent annual wellness visits
address commenters’ concerns regarding
referrals for community-based services,
mental health issues, and medical
nutrition therapy. Therefore, we are not
making the requested changes.
(3) Additional Comments
Comment: One commenter was
concerned that the term ‘‘physician’’ is
defined, for purposes of the definition of
‘‘health professional,’’ to be either a
doctor of medicine or a doctor of
osteopathy as defined in section
1861(r)(1) of the Act. The commenter
suggests that we use the full definition
of ‘‘physician’’ as defined in section
1861(r) of the Act, instead. The
commenter stated that doctors
accredited through the Council on
Chiropractic Education are prepared to
practice as primary care chiropractic
physicians.
Response: We did not propose to
make any changes to the definition of
‘‘physician’’ as used in § 410.15 in the
proposed rule and this comment is
outside the scope of our current
rulemaking. We are not making any
changes in this final rule.
Comment: One commenter suggested
that fall risk screening should be
administered by physical therapists and
other appropriately qualified
professionals, along with requiring, for
those individuals at risk for falls, that
physical therapists create a plan of care.
Response: While we appreciate the
commenter’s concerns, we are not
assigning particular tasks for specific
members of the team, such as those
tasks suggested by the commenter, in
this final rule. We believe it is better for
the supervising physician to assign
specific tasks to qualified team members
(as long as they are licensed in the State
and working within their State scope of
practice). This approach gives the
physicians and the team the flexibility
needed to address the beneficiary’s
particular needs on a particular day. It
also empowers the physician to
determine whether specific medical
professionals (such as physical or
occupational therapists) who will be
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73311
working on his or her wellness team are
needed on a particular day. The
physician is able to determine the
coordination of various team members
during the annual wellness visit.
Comment: Another commenter
requested that the Secretary use
authority under § 4105 of the Affordable
Care Act to remove the IPPE referral
requirement for abdominal aortic
aneurysm screening, and make the onetime screening available via referral
during the annual wellness visit.
Response: This comment is outside
the scope of our proposed rulemaking as
we made no proposals with respect to
section 4105 of the Affordable Care Act.
Our current coverage for abdominal
aortic aneurysm screening is established
in § 410.19. Thus, we are not making
any changes based on this comment at
the present time.
Comment: One commenter expressed
concern that the proposed rule did not
include voluntary advanced care
planning as part of the annual wellness
visit and was disappointed that the
proposed rule was silent on this issue.
Response: In the proposed rule, we
did not propose to add voluntary
advanced care planning to the
definitions for first or subsequent
annual wellness visits. We are not
making changes as suggested by this
commenter at this time.
Comment: We received a few
comments regarding the relationship
between the IPPE and the annual
wellness visit. Some commenters
recommended that we eliminate the
IPPE since they believe that it is similar
to the provisions of the annual wellness
visit.
Response: We appreciate the attention
drawn to the similarity between the
IPPE and the annual wellness visit.
While we did model some elements of
the annual wellness visit after elements
in the IPPE, we note that these statutory
provisions are separate and distinct
benefits and that Medicare beneficiaries
are eligible to receive both of these
benefits in sequence if regulatory
requirements are met.
Comment: A few commenters were
disappointed that CMS did not add
screening for depression and screening
for risk of falls to the elements included
in subsequent annual wellness visits.
Commenters disagreed with CMS’
assertion that lack of information
regarding optimal frequency for
depression screening was a sufficient
reason for not including depression
screening in subsequent annual
wellness visits, and that the risk of
change over a 12-month period is
significant.
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Response: We agree that depression
screening is important. Effective
October 14, 2011, Medicare covers
screening for depression in adults as an
‘‘additional preventive service.’’ The
decision memorandum is available on
the CMS Coverage Web site at https://
www.cms.gov/medicare-coveragedatabase/details/nca-decision-memo.
aspx?NCAId=251&
ver=6&NcaName=Screening
+for+Depression+
in+Adults&bc=AiAAAAAAIAAA&. We
believe that providing this screening as
a separate Part B benefit will help to
address the commenter’s concerns.
We also acknowledge that assessment
of functional ability and level of safety
are important, and we agree that for
certain individuals, functional status
and safety assessments (for example, fall
prevention) may be important to
consider on a more routine basis. The
annual wellness visit does allow for an
individualized approach with a
personalized prevention plan. For
certain individuals where these areas
are determined to be priorities, specific
evaluations may be voluntary parts of
subsequent visits. We also note that the
HRA (which is updated during
subsequent annual wellness visits)
includes components related to
functional ability and level of safety
such as self assessment of health status,
frailty, physical functioning, and
behavioral risks, such as seat belt use
and home safety. Therefore, we are not
making the suggested changes.
Comment: We received several
comments requesting that we expand or
modify Medicare coverage of preventive
services.
Response: While we appreciate the
commenters’ support for expanded
coverage of preventive services under
the Part B program, we did not solicit
comments concerning ‘‘additional
preventive services’’ in our proposed
rule and these comments are outside the
scope of this rulemaking. To the extent
that the public is seeking expanded
coverage for additional preventive
services under § 410.64, we are required
by statute to use the national coverage
determination process. Information on
how to request an NCD is available in
our Guidance Document: ‘‘Factors CMS
Considers in Opening a National
Coverage Determination,’’ at https://
www.cms.gov/mcd/
ncpc_view_document.asp?id=6. We will
also continue to monitor access to
preventive services and may also
consider using the authority granted by
section 4105 of the Affordable Care Act
in the future.
Comment: One commenter
recommended that CMS provide more
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education and outreach regarding the
annual wellness visit. Others requested
that CMS provide guidance to
beneficiaries and health professionals
regarding the elements included in the
annual wellness visit.
Response: We agree that it is
important to provide information about
Medicare’s coverage of the annual
wellness visit. We have conducted
significant educational campaigns in
2011 to encourage the use of the annual
wellness visit. We will issue other
educational information to Medicare
providers and beneficiaries, including
an MLNMatters article regarding
implementation of the changes to the
annual wellness visit as described in
this final rule.
(4) Summary
In summary, as a result of the
comments received, we are finalizing
the provisions of the proposed rule,
with the following modifications, in this
final rule:
• We are modifying sub-paragraph
(v)(C) of the definition of the term
‘‘health risk assessment’’ to read,
‘‘Psychosocial risks, including but not
limited to, depression/life satisfaction,
stress, anger, loneliness/social isolation,
pain, and fatigue’’ to correct a
typographical error in the proposed
rule.
• We are modifying paragraph (v)(D)
of the definition of the term ‘‘health risk
assessment’’ to read, ‘‘Behavioral risks,
including but not limited to, tobacco
use, physical activity, nutrition and oral
health, alcohol consumption, sexual
health, motor vehicle safety (seat belt
use), and home safety.’’
• We are modifying the introductory
text of the definition of the term
‘‘subsequent annual wellness visit
providing personalized prevention plan
services’’ to read as follows:
‘‘subsequent annual wellness visit
providing personalized prevention plan
services means the following services
furnished to an eligible beneficiary by a
health professional that include, and
take into account the results of an
updated health risk assessment, as those
terms are defined:’’
• We are modifying newly designated
paragraph (i) of the definition of
‘‘subsequent annual wellness visit
providing personalized prevention plan
services’’ to read as follows: ‘‘(i) Review
(and administration, if needed) of an
updated health risk assessment (as
defined in this section).’’
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2. The Addition of a Health Risk
Assessment as a Required Element for
the Annual Wellness Visit Beginning in
2012
a. Payment for AWV Services With the
Inclusion of an HRA Element
In the CY 2011 PFS final rule with
comment period (75 FR 73411), we
stated ‘‘that when the HRA is
incorporated in the AWV, we will
reevaluate the values for HCPCS codes
G0438 and G0439’’. As discussed in the
CY 2011 PFS final rule with comment
period, the services described by CPT
codes 99204 and 99214 already include
‘‘preventive assessment’’ forms. For CY
2012, we believe that the current
payment crosswalk for HCPCS codes
G0438 and G0439 continue to be most
accurately equivalent to a level 4 E/M
new or established patient visit; and
therefore, we proposed to continue to
crosswalk HCPCS codes G0438 and
G0439 to CPT codes 99204 and 99214,
respectively.
Comment: Commenters were
generally supportive of the addition of
the HRA element when furnishing AWV
services effective January 1, 2012.
However, many commenters disagreed
that the CDC guidance that the HRA is
best completed on-line and prior to an
AWV visit was appropriate for the
Medicare population. One commenter
noted that ‘‘access to a meaningful HRA
requires accommodation for individuals
with physical, sensory, or cognitive
limitations’’ and Medicare beneficiaries
often have multiple co-morbidities that
will limit their ability to complete an
HRA without assistance from a health
professional.
Most commenters agreed that CPT
codes 99204 and 99214 include
‘‘preventive assessment,’’ but continued
to believe the payment is insufficient for
the complexity of the HRA elements
created by CDC and that the
administration of the HRA will place a
burden on practitioners and, even more
so on their office staff, for which they
would not be compensated under the
equivalent of a level 4 E/M office visit
payment. We wish to clarify that not
only does the physician work in 99204
and 99214 include ‘‘preventive
assessment’’ but that we finalized in our
2011 PFS final rule with comment
period (75 FR 73409) the addition of
preventive assessment forms as a direct
PE input to HCPCS codes G0438 and
G0439 as we had for HCPCS code G0402
(Initial preventive physical
examination; face-to-face visit, services
limited to new beneficiary during the
first 12 months of Medicare enrollment)
in addition to the PE inputs for CPT
Codes 99204 and 99214.
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from the current level 4 E/M service to
include greater clinical labor time. We
believe that some beneficiaries may be
able to complete the HRA on their own,
that others may need assistance
completing the HRA, and that many will
need some assistance completing more
challenging questions. Because the CDC
estimates that an HRA should take no
more than 20 minutes to complete, we
increased the clinical labor time for the
initial AWV by half, 10 minutes, to
reflect additional staff work across the
range of beneficiary capability. For the
subsequent AWV, typically we would
expect Medicare beneficiaries to update
the HRA. Therefore, we increased the
clinical labor time for the subsequent
AWV by 5 minutes. In response to the
commenter request that we add the
RVUs for CPT code 99420
(Administration and interpretation of a
Health Risk Assessment Instrument) to
the AWV RVUs, we note that our
addition of 10 minutes to the initial
AWV is similar to the 15 minutes of
clinical labor time the AMA RUC has
valued for 99420. Currently this code is
not covered, and CMS has not reviewed
the RUC’s recommended RVUs. The
AMA RUC’s valuation of 99420 also
includes a paper booklet. We have not
included that additional practice
expense input into the RVUs for the
AWV because it duplicates the
‘‘preventive assessment forms’’ already
included in the direct PE inputs for
HCPCS codes G0438 and G0439.
We disagree with the commenters that
believe review of the HRA during the
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AWV requires additional physician
work. The level 4 E/M code RVUs that
are used to establish payment for the
initial and subsequent AWV already
include physician review of preventive
assessment forms. While we agree that
greater staff time will be required to
help Medicare beneficiaries to complete
the HRA, we do not believe that review
of the HRA during the visit constitutes
more physician work than is already
contemplated by a level 4 E/M visit.
In consideration of public comments,
we are finalizing our CY 2012 proposal
for the first and subsequent AWV
services with modification. Beginning
January 1, 2012, we will crosswalk
G0438 and G0439 to CPT codes 99204
and 99214, with the addition of direct
PE inputs for preventive assessment
forms as finalized in CY 2011 final rule
with comment period (75 FR 73409)
and, for CY 2012, an increase the direct
PE inputs for clinical labor time to
recognize an additional 10 and 5
minutes, respectively. We agree with
commenters that furnishing a
meaningful HRA to Medicare
beneficiaries will require
accommodation and that those
beneficiaries may need assistance from
physician office staff when completing
the HRA. The following Table 39, shows
the final total RVUs adjusted for the
inclusion of additional clinical labor
time to support beneficiary completion
of the required HRA element during the
first and subsequent AWV services
furnished on or after January 1, 2012.
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Many commenters did not identify a
specific adjustment to account for the
additional complexity introduced by the
HRA, but indicated that they should be
compensated for the additional time
that their staff will have to dedicate to
helping Medicare beneficiaries complete
the HRA over the phone or in person at
their AWV. A few commenters provided
a specific recommendation for reflecting
staff resources needed to support the
HRA and suggested that CMS add the
RVUs for CPT code 99420
(Administration and interpretation of a
Health Risk Assessment Instrument),
which is currently not covered, to the
current practice expense RVUs for the
AWV. Some commenters requested that
CMS add additional physician work
RVUs to the AWV without specifying
how much to add. One commenter
suggested adding CPT code 99406
(smoking and tobacco use cessation
visit, intermediate, greater than 3
minutes up to 10 minutes) to the level
4 payment to reflect the additional
physician work associated with adding
the HRA element to the AWV visit.
Response: We appreciate commenters’
support of the addition of the HRA
element. We agree with commenters
that Medicare beneficiaries likely will
need assistance from physician office
staff in completing the HRA envisioned
in the CDC Interim Guidance on Health
Risk Assessments available at https://
www.cms.gov/coveragegeninfo/
downloads/
healthriskassessmentsCDCfinal.pdf.
Therefore, we will increase the PE RVUs
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participation are described in this
section.
F. Quality Reporting Initiatives
1. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
a. Program Background and Statutory
Authority
The Physician Quality Reporting
System is a quality reporting program
that provides incentive payments and
payment adjustments to identified
eligible professionals who satisfactorily
report data on quality measures for
covered professional services furnished
during a specified reporting period. The
Physician Quality Reporting System was
initially implemented in 2007 as a result
of section 101 of Division B of the Tax
Relief and Health Care Act of 2006. The
Physician Quality Reporting System was
extended and further enhanced as a
result of the Medicare, Medicaid, and
SCHIP Extension Act of 2008 (MMSEA),
the Medicare Improvements for Patients
and Providers Act of 2009 (MIPPA),
which was enacted on July 15, 2008,
and the Affordable Care Act, which was
enacted on March 23, 2010.
Changes to the Physician Quality
Reporting System as a result of these
laws, as well as information about the
Physician Quality Reporting System in
2007, 2008, 2009, 2010, and 2011 are
discussed in detail in the CY 2008 PFS
proposed and final rules (72 FR 38196
through 38204 and 72 FR 66336 through
66353, respectively), CY 2009 PFS
proposed and final rules (73 FR 38558
through 38575 and 73 FR 69817 through
69847, respectively), CY 2010 PFS
proposed and final rules (74 FR 33559
through 33600 and 74 FR 61788 through
61861, respectively), and CY 2011 PFS
proposed and final rules (75 FR 73487
through 73552). Further detailed
information, about the Physician
Quality Reporting System, related laws,
and help desk resources, is available on
the CMS Web site at https://
www.cms.gov/PQRS.
We received numerous comments that
were not related to our specific
proposals for the 2012 Physician
Quality Reporting System. While we
appreciate the commenters’ feedback,
these comments are outside the scope of
the issues addressed in this final rule
with comment period.
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b. Methods of Participation
There are two ways an eligible
professional may participate in the
Physician Quality Reporting System: (1)
as an individual eligible professional or
(2) as part of a group practice under the
Physician Quality Reporting System
group practice reporting option (GPRO).
The details of each method of
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(1) Individual Eligible Professionals
As defined at 42 CFR 414.90(b) the
term ‘‘eligible professional’’ means any
of the following: (1) a physician; (2) a
practitioner described in section
1842(b)(18)(C) of the Act; (3) a physical
or occupational therapist or a qualified
speech-language pathologist; or (4) a
qualified audiologist. For more
information on which professionals are
eligible to participate in the Physician
Quality Reporting System, we refer
readers to the ‘‘List of Eligible
Professionals’’ download located in the
‘‘How to Get Started section of the
Physician Quality Reporting CMS Web
site at: https://www.cms.gov/PQRS/03_
How_To_Get_Started.asp#TopOfPage.
(2) Group Practices
(A) Background and Authority
As required by section
1848(m)(3)(C)(i) of the Act, we
established and have had in place since
January 1, 2010, a process under which
eligible professionals in a group practice
are treated as satisfactorily submitting
data on quality measures under the
Physician Quality Reporting System if,
in lieu of reporting measures under the
Physician Quality Reporting System, the
group practice reports measures
determined appropriate by the
Secretary, for example measures that
target high-cost chronic conditions and
preventive care, in a form and manner,
and at a time specified by the Secretary.
Section 1848(m)(3)(C)(ii) of the Act
requires that this process provide for the
use of a statistical sampling model to
submit data on measures, for example
the model used under the Medicare
Physician Group Practice (PGP)
demonstration project under section
1866A of the Act. We established a
GPRO for the Physician Quality
Reporting System under 42 CFR
414.90(g).
(B) Definition of Group Practice
Under 42 CFR 414.90(b), a ‘‘group
practice’’ means ‘‘a single Tax
Identification Number (TIN) with two or
more eligible professionals, as identified
by their individual National Provider
Identifier (NPI), who have reassigned
their Medicare billing rights to the TIN’’.
We proposed (76 FR 42840) to change
the definition of ‘‘group practice’’ under
42 CFR 414.90(b). Specifically, we
proposed that under the Physician
Quality Reporting System, a ‘‘group
practice’’ would consist of a physician
group practice, as defined by a TIN,
with 25 or more individual eligible
professionals (or, as identified by NPIs)
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who have reassigned their billing rights
to the TIN.
For the 2010 Physician Quality
Reporting System, our definition of
‘‘group practice’’ was limited to
practices with 200 or more eligible
professionals because our intent was to
model the Physician Quality Reporting
System GPRO after a quality reporting
program that group practices may
already be familiar with—the PGP
demonstration. Since participation in
the PGP demonstration was limited to
large group practices, we wanted to
initially limit participation in the
Physician Quality Reporting System
GPRO to similar large group practices.
In 2011, we expanded this definition to
include practices with 2–199 eligible
professionals because we developed a
second reporting option (GPRO II)
specifically for smaller group practices
that was based largely on the Physician
Quality Reporting System reporting
options for individual eligible
professionals. We have since observed
that many of these smaller group
practices that self-nominated to
participate in GPRO II for 2011
subsequently elected to opt out of
participation in the GPRO II for 2011 so
that members of the group practices can
participate in the Physician Quality
Reporting System individually instead.
Out of 107 total groups that selfnominated for GPRO II, only 25 group
practices comprised of 2–10 eligible
professionals and 15 group practices
comprised of 11–25 eligible
professionals are still participating in
GPRO II for 2011 at this time.
Since the GPRO II seems to be a less
attractive reporting option than GPRO I,
we proposed (76 FR 42840) to
consolidate GPRO I and II into a single
GPRO. Since our experience with using
the GPRO submission web interface
under the Physician Quality Reporting
System has been limited to larger
practices or practices participating in
demonstration projects, we hesitated to
expand what we referred to as GPRO I
to all group practices until we gain some
experience with smaller practices on a
larger scale. For example, we believe
that participation under the Physician
Quality Reporting System GPRO is a
more effective method of participation
for larger as opposed to smaller group
practices. As described in section
VI.F.1.e.6 of this final rule with
comment period, a group practice must
take extra steps to participate in the
Physician Quality Reporting System
GPRO, for example reporting on more
measures overall than is required for
individual eligible professionals. In
contrast, members of a group practice
who choose to participate in the
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Physician Quality Reporting System as
individual eligible professionals could
satisfactorily report by reporting as few
as 3 measures. We believe the additional
reporting burden associated with
participating under the Physician
Quality Reporting System GPRO may
make the GPRO less attractive for
smaller practices. We also believe that
smaller group practices are more closely
akin to individual eligible professionals
with respect to participation under the
Physician Quality Reporting System.
For these reasons, we proposed to
change the definition of ‘‘group
practice’’ at 42 CFR 414.90(b) to groups
with 25 or more eligible professionals.
We recognize that a group’s size can
fluctuate throughout the year as
professionals move from practice to
practice. We allow for fluctuation of the
group practice’s size throughout the
reporting period. However, we proposed
(76 FR 42840) that the group practice’s
size after the group practice’s
participation is approved by CMS must
continue to meet the definition of a
group practice as proposed in 42 CFR
414.90(b) for the entire reporting period.
We also proposed (76 FR 42840) that
under 42 CFR 414.90(g)(1), a group
practice of any size (including solo
practitioners) or comprised of multiple
TINs participating in a Medicare
approved demonstration project of other
programs would also be deemed to be
participating in the Physician Quality
Reporting System GPRO. For example,
the PGP demonstration, as well as the
Medicare Shared Savings Program
(governing accountable care
organizations (ACOs)), and Pioneer ACO
have incorporated or proposed to
incorporate aspects of the Physician
Quality Reporting System reporting
requirements and incentives under
those respective programs.
Our intention to recognize (deem)
group practices participating in such
other programs or demonstration
projects as having participated in the
Physician Quality Reporting System was
to ensure that such groups would not be
barred from participating in the group
practice reporting option under the eRx
Incentive program, since we previously
required and have proposed to continue
to require that group practices interested
in participating in the eRx Incentive
Program GPRO also participate in the
Physician Quality Reporting System
GPRO. We are not changing the
eligibility for group practices, including
those participating in the programs
mentioned previously, to participate in
the eRx Incentive program. As discussed
in the changes to the eRx Incentive
Program in section VI.F.1.e.2. later in
this final rule with comment period,
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however, a group practice must selfnominate to participate under the eRx
Incentive Program’s group practice
reporting option. We invited comments
on the proposed change to the definition
of ‘‘group practice’’ under 42 CFR
414.90(b) under the Physician Quality
Reporting System and also, whether we
should retain the existing definition
under the regulation despite our
proposal to retain only the GPRO I for
2012. Following is a summary of the
comments received that were related to
this proposal.
Comment: Some commenters
supported our proposed definition of
group practice. One commenter
supported our proposed definition of
group practice due to low participation
by smaller group practices in the 2011
GPRO II. Other commenters supported
our proposed inclusion of smaller group
practices comprised of 25–199 eligible
professionals into the 2011 GPRO I
model.
Response: We agree. For the reasons
stated previously, we are finalizing our
proposal to change the definition of
‘‘group practice’’ at 42 CFR 414.90(b) to
groups with 25 or more eligible
professionals.
Comment: One commenter opposed
our proposal to eliminate GPRO II and
only allow group practices to participate
under GPRO I. The commenter noted
that the low participation rate was likely
due to the limited number of measures
groups available for reporting.
Response: We appreciate the
commenter’s feedback. However, due to
low participation in GPRO II in 2011
and the fact that the number of
measures groups available for reporting
in 2012 remains limited, we are
eliminating the GPRO II reporting
option for 2012. We are continuing to
explore other options that would enable
smaller group practices to participate in
GPRO for future years of the program.
Comment: Several commenters were
opposed to our proposal to define group
practices as groups consisting of 25 or
more eligible professionals. These
commenters urged us to continue to
include groups consisting of 2–24
eligible professionals to participate in
the Physician Quality Reporting System
GPRO.
Response: As stated previously, in
2011, we expanded the 2010 definition
of group practice to include groups
comprised of 2–199 eligible
professionals because we developed
GPRO II, but we proposed to eliminate
the GPRO II reporting option due to low
participation levels in GPRO II. To
reflect our desire to continue to have
group practices smaller than 200 eligible
professionals participate in the 2012
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73315
Physician Quality Reporting System
GPRO, we proposed to change the
definition of group practice to groups
comprised of 25 or more eligible
professionals. We are interested in
allowing group practices comprised of
less than 25 eligible professionals to
participate in the Physician Quality
Reporting System via the GPRO in the
future. However, at this time, it is not
operationally feasible for us to allow
groups smaller than 25 eligible
professionals to participate in GPRO, as
the sampling methodology and method
for reporting under the GPRO was
designed to accommodate larger groups.
We are thinking of ways to modify this
GPRO to accommodate smaller groups
in the future. Furthermore, it is not
likely that group practices comprised of
2–24 eligible professionals will be able
to meet the patient sample threshold for
satisfactory reporting under the GPRO.
We are working to develop the GPRO so
that it may be a viable reporting option
for group practices smaller than 25
eligible professionals in future program
years.
Comment: One commenter stated that,
although the commenter believed that it
was reasonable to require that a group
practice continue to meet the definition
of a group practice while participating
in the Physician Quality Reporting
System GPRO, the commenter suggested
that we provide notice to groups that
fall below the group practice definition
during the reporting period.
Response: The group size is
determined at the time of selfnomination and during the first quarter
vetting period. However, if we find that
a group practice should fall below our
finalized minimum group size of 25 at
any point during the reporting period, if
feasible, we will work with the group
practice to inform the group practice of
its remaining reporting options, since,
as the group size would be smaller than
our minimum group practice size
threshold, the group would cease to be
able to participate under the Physician
Quality Reporting System GPRO.
Based on the comments received and
for the reasons stated above, we are
finalizing our proposal to change the
definition of ‘‘group practice’’ at 42 CFR
414.90(b) to recognize groups with 25 or
more eligible professionals. In addition,
as we did not receive comments to make
a technical change to 42 CFR
414.90(g)(1) to eliminate the reference to
group practices in demonstrations that
are deemed to have participated in the
Physician Quality Reporting System, we
are finalizing that change to the
regulation. We believe that this language
is unnecessary given the regulation at 42
CFR 414.92(b). In addition, we believe
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that retaining the reference at 42 CFR
414.90(g)(1) may cause confusion with
regard to participation under the
Physician Quality Reporting System or
inappropriately suggest that duplicate
Physician Quality Reporting System
incentive payments are available to
group practices under both the
Physician Quality Reporting System and
the other types of programs mentioned
previously. We are also finalizing our
proposal to make a technical change to
42 CFR 414.92(b), which defines group
practices participating under the eRx
GPRO discussed in section VI.F.2.b. of
this final rule, to more broadly address
group practices in other types of
programs that incorporate Physician
Quality Reporting System reporting
requirements and incentives, so that the
regulation does not solely reference
demonstrations.
(C) Process for Physician Group
Practices To Participate as Group
Practices
In order to participate in the
Physician Quality Reporting System
GPRO for 2012 and subsequent years,
we proposed to require group practices
to complete a self-nomination process
and to meet certain technical and other
requirements described in the proposed
rule (76 FR 42841 and 42842). As in
prior years, we proposed to require
these self-nomination and additional
process requirements so that we may
identify which group practices are
interested in participating in the
Physician Quality Reporting System as
a GPRO as well as to ensure that group
practices participating in the GPRO
understand the process for satisfactorily
reporting Physician Quality Reporting
System quality measures under the
GPRO method of reporting.
We proposed that the self-nomination
statement would be submitted by the
group practice wishing to participate in
the GPRO for the first time via a webbased tool. However, we also stated that
if it is not operationally feasible for us
to collect self-nomination statements via
a web-based tool for 2012, we would
require group practices interested in
participating in the Physician Quality
Reporting System GPRO to submit a
self-nomination statement via a letter
accompanied by an electronic file
submitted in a format specified by us
(such as a Microsoft Excel file). At this
time, it is not technically feasible to
collect self-nomination statements via a
web-based tool. Therefore, until the
web-based tool is fully capable of
accepting self-nomination statements,
we are finalizing our proposal that
group practices submit the selfnomination statement via a letter
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accompanied by an electronic file
submitted in a format specified by us
(such as a Microsoft Excel file) that
includes the group practice’s TIN(s) and
name of the group practice, the name
and email address of a single point of
contact for handling administrative
issues as well as the name and email
address of a single point of contact for
technical support purposes. However,
once the web-based tool is capable of
accepting self-nomination statements,
which we anticipate will occur by the
2013 Physician Quality Reporting
System, the web-based tool is the
method for a group practice to submit a
self-nomination statement for the
respective program year.
A group practice that submits an
incomplete self-nomination statement
(such as, a valid email address is not
provided), would not be considered for
inclusion in the 2012 Physician Quality
Reporting System GPRO, though as we
noted in the proposed rule, we would
notify a group practice should we
receive an incomplete self-nomination
statement.
We proposed that the Physician
Quality Reporting System GPRO selfnomination statement must also
indicate the group practice’s compliance
with the following requirements:
• Agree to attend and participate in
all mandatory GPRO training sessions.
• Is an established Medicare provider
that has billed Medicare Part B on or
after January 1 and prior to October 29
of the year prior to the reporting period
for the respective year. For example, for
purposes of participating in the 2012
Physician Quality Reporting System
GPRO, the group practice must have
billed Medicare Part B on or after
January 1, 2011 and prior to October 29,
2011.
• Agree to have the results on the
performance of their Physician Quality
Reporting System measures publicly
posted on the Physician Compare Web
site.
• Obtain and/or have access to the
identity management system specified
by CMS (such as, but not limited to, the
Individuals Authorized Access to CMS
Computer Systems, or IACS) to submit
Medicare clinical quality data to a CMS
clinical data warehouse.
• Provide CMS access (upon request
for health oversight purposes like
validation) to review the Medicare
beneficiary data on which Physician
Quality Reporting System GPRO
submissions are founded or provide to
CMS a copy of the actual data (upon
request for health oversight purposes
like validation).
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To ensure that accurate data is being
reported, we reserve the right to validate
the data submitted by GPROs.
For 2012 and future years, we
proposed that a group practice that
wishes to participate in both the
Physician Quality Reporting System and
eRx GPRO (see the eRx Incentive
Program’s section VI.F.2.(b).(2).(B) of
this final rule with comment period)
must indicate its desire to participate in
both programs in its self-nomination
statement.
In addition, in the proposed rule (76
FR 42841 and 42842), we stated that we
were interested in testing the extraction
of EHR data submitted by group
practices through the GPRO web
interface in 2012. Group practices
wishing to participate in this test must
state their interest to participate in the
group practice’s self-nomination letter.
We further proposed (76 FR 42842)
that group practices that wish to selfnominate must do so by January 31 of
the calendar year in which the group
practice wishes to participate in the
Physician Quality Reporting System
GPRO. For example, in order to
participate in the GPRO for the 2012
Physician Quality Reporting System, the
group practice will need to selfnominate by January 31, 2012. Upon
receipt of the self-nomination
statements, we would assess whether
the participation requirements for the
respective reporting period were met by
each group practice using Medicare
claims data from the year prior to the
respective reporting period. We would
not preclude a group practice from
participating in the GPRO if we
discover, from analysis of the Medicare
claims data, that there are some eligible
professionals (identified by NPIs) that
are not established Medicare providers
(that is, have not billed Medicare Part B
on or after January 1 and prior to or on
October 29 of the year prior to the
respective reporting period) as long as
the group has at least the minimum
proposed number (that is, 25) of
established Medicare providers required
to participate in the Physician Quality
Reporting System as a group practice.
Eligible professionals, as classified by
their NPIs, who do not submit Medicare
Part B claims for PFS covered
professional services during the
reporting period, however, will not be
included in our payment calculations.
Furthermore, we proposed (76 FR
42842) that group practices who have
previously participated in the Physician
Quality Reporting System GPRO would
automatically be qualified to participate
in the GPRO in 2012 and future program
years. For example, group practices that
were selected to participate in the 2011
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Physician Quality Reporting System
GPRO I or GPRO II (provided the group
practice is still comprised of at least 25
eligible professionals) would
automatically be qualified to participate
in the 2012 Physician Quality Reporting
System GPRO and will not need to
complete the 2012 Physician Quality
Reporting System GPRO qualification
process. These practices will, however,
need to notify CMS in writing of their
desire to continue participation in the
Physician Quality Reporting System
GPRO for the respective program year.
We indicated that we recognized that,
for various reasons, there potentially
could be a discrepancy between the
number of eligible professionals (that is,
NPIs) submitted by the practice during
the self-nomination process and the
number of eligible professionals billing
Medicare under the practice’s TIN as
people move in and out of practices.
Therefore, if we find more NPIs in the
Medicare claims than the number of
NPIs submitted by the practice during
the self-nomination process and this
will result in the practice being subject
to different criteria for satisfactory
reporting, we will notify the practice of
this finding as part of the selfnomination process. At this point, the
practice will have the option of either
agreeing to be subject to the different
criteria for satisfactory reporting or
opting out of participation in the
Physician Quality Reporting System
GPRO to enable the members of their
practice to participate in the Physician
Quality Reporting System as individual
eligible professionals.
We invited public comment regarding
our proposed process for group
practices to participate in the Physician
Quality Reporting System GPRO. We
received the following comment
regarding this proposal.
Comment: One commenter stated that,
instead of requiring group practices who
have previously participated in the
Physician Quality Reporting System
GPRO in prior years to self-nominate
each year, we should consider group
practices who have formerly
participated in the Physician Quality
Reporting System GPRO as participating
until the group practice opts out of
GPRO participation.
Response: We appreciate the
commenter’s feedback. However, we
note that the self-nomination process
that we have proposed and are
finalizing applies only to group
practices that wish to participate in the
Physician Quality Reporting System
GPRO for the first time. Group practices
that have previously participated in the
GPRO do not need to submit a selfnomination statement to indicate their
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desire to participate in the GPRO in
future program years. However, we note
that group practices that have
previously participated in the GPRO
may have to participate in other GPRO
activities, such as attending
informational sessions that demonstrate
how to report under the GPRO for the
respective program year.
Based on the comments received and
for the reasons stated previously, we are
finalizing the self-nomination and
participation processes for group
practices under the Physician Quality
Reporting System GPRO. As we noted
previously, it was not technically
feasible to develop a web-based tool by
the time of this final rule, and therefore,
for 2012, self-nomination statements
must be submitted via a letter
accompanied by and electronic file
described previously.
c. Reporting Period
Since the implementation of the
Physician Quality Reporting System in
2007, depending on an eligible
professional’s chosen reporting
mechanism, we have offered up to two
different reporting periods for
satisfactorily reporting Physician
Quality Reporting System quality
measures: a 12-month reporting period
(from January 1 through December 31of
the respective program year) and a 6month reporting period (from July 1
through December 31of the respective
program year). Section 1848(m)(5)(F) of
the Act requires CMS to provide
alternative reporting periods and criteria
for measures groups and registry
reporting. To comply with this
provision, for 2012 and subsequent
years, we proposed (76 FR 42842) to
retain the 6-month reporting period
option for the reporting of Physician
Quality Reporting System measures
groups via registry. We invited but
received no comments on our proposal
to retain the 6-month reporting period
for measures groups via registry. For the
reasons described previously, we are
finalizing our proposal to retain the 6month reporting period for 2012 and
beyond. We are therefore modifying 42
CFR 414.90(f)(1)(ii)(B) to reflect this
finalized proposal.
Additionally, we proposed (76 FR
42842) to modify 42 CFR § 414.90(g)(1)
to specify a 12-month reporting period
(that is, January 1through December
31of the respective program year) for the
Physician Quality Reporting System
GPRO. We received no comments
regarding our proposal to modify 42
CFR § 414.90(g)(1) to specify a 12-month
reporting period (that is, January 1
through December 31of the respective
program year) for the Physician Quality
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Reporting System GPRO for 2012 and
beyond, and are therefore, finalizing this
proposal. As such, we are making
technical changes to modify the clause
numbers under
42 CFR 414.90(g) to reflect our finalized
proposal to indicate a 12-month
reporting period for the GPRO under 42
CFR 414.90.
Furthermore, for 2012 and subsequent
years, we proposed (76 FR 42842) to
modify 42 CFR 414.90(f)(1) to specify a
12-month reporting period (that is,
January 1 through December 31of the
respective program year), consistent
with section 1848(m)(6)(C)(i)(II) of the
Act, for the satisfactory reporting of
Physician Quality Reporting System
quality measures for claims, registry,
and EHR-based reporting. In proposing
these modifications to 42 CFR 414.90,
we proposed to eliminate the 6-month
reporting period for claims and registry
previously available under the
Physician Quality Reporting System
(with the exception of reporting
measures groups via registry). Although
we did not propose a 6-month reporting
period for claims and registry reporting,
we note that the 12-month reporting
period aligns with other CMS quality
reporting programs. In addition, the
elimination of the 6-month reporting
period for claims and registry reporting
(for reporting individual measures via
registry) will align the reporting periods
of these mechanisms with the EHR
reporting mechanism and the GPRO. We
further believe that the elimination of
the 6-month reporting period for claims
and registry reporting (for reporting
individual measures via registry) will
help to streamline and simplify the
reporting requirements for the Physician
Quality Reporting System without
substantial burden to eligible
professionals who may still
satisfactorily report using the 12-month
reporting period.
We invited public comment on our
proposal to eliminate the 6-month
reporting period for claims and registry
reporting (for reporting individual
measures via registry). The following is
a summary of the comments regarding
this proposal.
Comment: Some commenters
supported our proposal to eliminate the
6-month reporting period as we
proposed. The commenters concurred
with our desire to align our reporting
periods with that of other CMS quality
reporting programs.
Response: We appreciate the
commenters’ support. We are finalizing
our proposal to eliminate the 6-month
reporting period claims and registry
reporting (individual measures via
registries).
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Comment: Several commenters were
opposed to our proposal to eliminate the
6 month reporting period for reporting
under the Physician Quality Reporting
System. One commenter suggested that
having an additional 6-month reporting
period in which to report would allow
eligible professionals to still correct
errors that are detected after the
distribution of interim feedback reports.
Another commenter stated that the 6month reporting period may be used by
eligible professionals as an additional
opportunity to meet the requirements
for satisfactory reporting under the
Physician Quality Reporting System.
Response: As we noted previously, we
are finalizing our proposal to retain the
6-month reporting option for reporting
on measures groups via registry.
Therefore, the 6-month reporting period
is still available to those eligible
professionals wishing to use this
reporting period. As we stated in the
proposed rule (76 FR 42842), we
proposed to eliminate the 6-month
reporting option (for certain
mechanisms and types of measures) in
order to streamline the program. We
understand that this eliminates
additional options under which eligible
professionals may participate in the
Physician Quality Reporting System.
However, we believe that data based on
a 12-month reporting period provides
more meaningful insight to patient
experience and care than data collected
during a shorter, 6-month reporting
period. The Tax Relief and Health Care
Act of 2006 (TRHCA), enacted on
December 20, 2006, required the
Secretary to implement the first
reporting period on July 1, 2007.
Therefore, a 6-month reporting period
from July 1, 2007 through December 31,
2007 was the first reporting period in
which eligible professionals could
report on quality measures under the
Physician Quality Reporting System
(then called the Physician Quality
Reporting Initiative or PQRI). We
retained the 6-month reporting option to
encourage participation in the program.
2012 will mark the 6th year of the
Physician Quality Reporting System. As
such, we believe that eligible
professionals have had ample time to
familiarize themselves with the program
and its requirements. Therefore, we
believe our desire to streamline the
program, align our reporting periods
with other various CMS programs, and
collect more meaningful data outweighs
stakeholders’ desire to retain the 6month reporting period we are
eliminating.
Based on the comments received and
for the reasons stated above, for 2012
and beyond, we are finalizing our
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proposal to modify 42 CFR 414.90(f)(1)
to specify a 12-month reporting period
(that is, January 1 through December
31of the respective program year) for the
satisfactory reporting of Physician
Quality Reporting System quality
measures for claims, registry, and EHRbased reporting. In addition to the 12month reporting period available for all
reporting methods, we are also
finalizing a 6-month reporting period
(that is, July 1 through December 31 of
the respective program year) for
reporting measures groups via registry.
d. Reporting Mechanisms—Individual
Eligible Professionals
For the purpose of reporting quality
measures under the Physician Quality
Reporting System, we proposed (76 FR
42842) to retain the claims-based,
registry-based, and EHR-based reporting
mechanism for 2012 and beyond.
Accordingly, we proposed to modify 42
CFR 414.9(f) to reflect this proposal. We
proposed to retain these reporting
mechanisms in order to provide eligible
professionals with multiple mechanisms
from which to satisfactorily report
Physician Quality Reporting System
quality measures. We hope that offering
multiple reporting mechanisms will aid
in encouraging participation in the
Physician Quality Reporting System.
We invited public comment
concerning the general, proposed
reporting mechanisms for the Physician
Quality Reporting System for 2012 and
beyond. The following is a summary of
the comments received that were related
to our proposal to retain the claims,
registry, and EHR-based reporting
mechanisms for 2012 and beyond.
Comment: One commenter suggested
that the program move towards one
method of reporting, rather than provide
different methods of reporting under the
Physician Quality Reporting System.
Response: We appreciate the
commenter’s feedback. However, as we
stated in the proposed rule (76 FR
42842), we believe it is important to
provide eligible professionals with
multiple reporting mechanisms to
encourage and facilitate satisfactory
participation in the Physician Quality
Reporting System. We also note that
eligible professionals continue to
actively utilize all 3 reporting
mechanisms. For example, the 2009
Reporting Experience indicates that in
2009, approximately 190,000 eligible
professionals and 33,000 eligible
professionals participated in the
Physician Quality Reporting System via
the claims-based and registry-based
reporting mechanism, respectively. The
EHR-based reporting mechanism was
not included as a Physician Quality
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Reporting System reporting mechanism
until 2010.
Comment: Several commenters
supported our proposal to retain the
claims, registry, and EHR-based
reporting mechanisms for 2012 and
beyond in order to provide multiple
reporting mechanisms for which eligible
professionals may use to report on
Physician Quality Reporting quality
measures.
Response: We agree and appreciate
the commenters’ feedback. We are
finalizing the claims, registry, and EHRbased reporting mechanisms for 2012
and beyond.
Comment: Some commenters
encouraged us to provide resources to
assist eligible professionals in choosing
a reporting mechanism.
Response: For 2012 and beyond, as in
previous years, we will provide various
resources to assist eligible professionals
in choosing a reporting mechanism as
well as general guidance on how to
participate in the Physician Quality
Reporting System through, for example,
resources posed on the Physician
Quality Reporting System Web site
(https://www.cms.gov/PQRS/), national
provider calls, special open door
forums, and the QualityNet Help Desk.
Based on the comments received and
for the reasons explained previously, we
are finalizing the claims, registry, and
EHR-based reporting mechanisms under
the Physician Quality Reporting System
for 2012 and beyond.
As in previous years, the individual
quality measures or measures groups an
eligible professional selects will dictate
the applicable reporting mechanism(s).
In addition, while eligible professionals
can attempt to qualify for a Physician
Quality Reporting System incentive
under multiple reporting mechanisms,
the eligible professional must satisfy the
criteria for satisfactory reporting for the
respective program year, with respect to
a single reporting mechanism to qualify
for an incentive. We will not combine
data submitted via multiple reporting
mechanisms to determine incentive
eligibility.
(1) Claims-Based Reporting
As we noted previously, we proposed
(76 FR 42843) to retain the claims-based
reporting mechanism for the Physician
Quality Reporting System for 2012 and
beyond. For eligible professionals who
choose to participate in the Physician
Quality Reporting System by submitting
data on individual quality measures or
measures groups through the claimsbased reporting mechanism, we
proposed (76 FR 42843) that the eligible
professional be required to submit the
appropriate Physician Quality Reporting
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System quality data codes (QDCs) on the
professionals’ Medicare Part B claims.
QDCs for the eligible professional’s
selected individual Physician Quality
Reporting System quality measures or
measures group may be submitted to
CMS at any time during the reporting
period for the respective program year.
However, as required by section
1848(m)(1)(A) of the Act, all claims for
services furnished during the reporting
period, would need to be processed by
no later than two months after the end
of the reporting period, to be included
in the program year’s Physician Quality
Reporting System analysis. For example,
all claims for services furnished for the
2012 Physician Quality Reporting
System would need to be processed by
no later than two months after the end
of the reporting period for the 2012
Physician Quality Reporting System,
that is, processed by February 22, 2013
for the reporting period that ends
December 31, 2012.
We invited public comment on our
proposed requirements for eligible
professionals who choose the claimsbased reporting mechanism for 2012
and beyond. The following is a
summary of the comments we received
regarding this proposal.
Comment: Some commenters
supported our proposal to retain the
claims-based reporting mechanism,
since many small practices may not be
linked to registry or EHR systems.
Response: We agree and appreciate
the commenter’s feedback.
Based on the comments received and
for the reasons stated in our responses
and above, we are finalizing our
proposal to retain the claims-based
reporting mechanism under the
Physician Quality Reporting System for
2012 and beyond.
(2) Registry-Based Reporting
(A) Requirements for the Registrybased Reporting Mechanism—
Individual Eligible Professionals
As stated previously, we proposed (76
FR 42843) to retain the registry-based
reporting mechanism via a qualified
registry (as defined in section
VI.F.1.2.B.) for the Physician Quality
Reporting System for 2012 and beyond.
With regard to specific requirements for
registry-based reporting for individual
eligible professionals under the
Physician Quality Reporting System, we
proposed that, in order to report quality
data on the Physician Quality Reporting
System individual quality measures or
measures groups for the respective
program year through a qualified
registry, an eligible professional or
group practice would be required to
enter into and maintain an appropriate
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legal arrangement with a qualified
Physician Quality Reporting System
registry. Such arrangements would
provide for the registry’s receipt of
patient-specific data from the eligible
professional and the registry’s
disclosure of quality measures results
and numerator and denominator data on
Physician Quality Reporting System
quality measures or measures groups on
behalf of the eligible professional to
CMS. Thus, the registry would act as a
Health Insurance Portability and
Accountability Act of 1996 (Pub. L.
104–191) (HIPAA) Business Associate
and agent of the eligible professional.
Such agents are referred to as ‘‘data
submission vendors.’’ The ‘‘data
submission vendors’’ would have the
requisite legal authority to provide
clinical quality measures results and
numerator and denominator data on
individual quality measures or measures
groups on behalf of the eligible
professional for the Physician Quality
Reporting System.
We proposed that the registry, acting
as a data submission vendor, would
submit CMS-defined, registry-derived
measures information to our designated
database for the Physician Quality
Reporting System, using a CMSspecified record layout, which will be
provided to the registry by CMS.
Similarly, we proposed that eligible
professionals choosing to participate in
the Physician Quality Reporting System
through the registry-based reporting
mechanism for the respective program
year must select a qualified Physician
Quality Reporting System registry and
submit information on Physician
Quality Reporting System individual
quality measures or measures groups to
the selected registry in the form and
manner and by the deadline specified
by the registry.
We proposed to post a list of qualified
registries for the Physician Quality
Reporting System for the respective
program year on the Physician Quality
Reporting System section of the CMS
Web site at https://www.cms.gov/pqrs,
which would include the registry name,
contact information, the measures and/
or measures group (if qualified) for
which the registry is qualified and
intends to report for the respective
program year, and information regarding
the cost of the registry to eligible
professionals. However, we do not
anticipate making this list available
prior to the start of the respective
program year. That is, we do not
anticipate making the list of qualified
registries for the 2012 Physician Quality
Reporting System available prior to the
start of the 2012 program year. We
anticipate posting the names of the
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Physician Quality Reporting System
qualified registries for the respective
reporting period in the following 3
phases based on: (1) the registry’s
success in submitting Physician Quality
Reporting System quality measures
results and numerator and denominator
data on the quality measures in a prior
Physician Quality Reporting System
program year (2008, 2009, 2010, 2011,
etc.); (2) the registry’s submission of a
letter indicating their continued interest
in being a Physician Quality Reporting
System registry by October 31 of the
year prior to the program year (that is,
by October 31, 2011 for the 2012
program year); and (3) the registry’s
compliance with the Physician Quality
Reporting System registry requirements
for the respective program year as
indicated by CMS’ registry vetting
process. The listing of a qualified
registry will depend on which of the 3
proposed phases is most applicable to
the registry. The manner in which we
post the list of qualified registries is
based on prior experience with
participation in the Physician Quality
Reporting System as a registry vendor.
We invited public comment on our
proposed process and requirements for
using the registry-based reporting
mechanism for individual eligible
professionals. The following is a
summary of the comments we received
regarding this proposal.
Comment: Several commenters
supported our proposal to retain the
registry reporting mechanism. One
commenter stated that eligible
professionals have met the criteria for
satisfactory reporting at greater rates
than when using the claims-based
reporting mechanism. Some
commenters stated that we should
encourage use of registry-based
reporting.
Response: We appreciate the
commenter’s feedback and are finalizing
our proposal to retain the registry-based
reporting mechanism.
Comment: One commenter noted that
use of the registry-based reporting
mechanism results in additional costs to
the eligible professional wishing to
participate in the Physician Quality
Reporting System via the registry-based
reporting mechanism.
Response: We understand that the use
of registries may result in additional
costs to the eligible professional, as
many registries charge for their services.
However, we note that the registrybased reporting mechanism optional
and is only one of three mechanisms
that may be used to report Physician
Quality Reporting System measures.
There is no up-front, monetary cost
associated with participating in the
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Physician Quality Reporting System via
the claims-based reporting mechanism.
Comment: One commenter suggested
that we develop a free, national registry
that would meet the requirements for
being a ‘‘qualified’’ registry so that a free
registry option would be available for
eligible professionals.
Response: We respectfully disagree.
As we noted previously, many but not
all registries charge for their services. As
such, it is possible for eligible
professionals to elect a free registry on
which to report Physician Quality
Reporting System quality measures. As
there are free registry options, we do not
see the need for a national registry.
Based on the comments received and
for the reasons stated previously, we are
finalizing the requirements described
above for individual eligible
professionals choosing the registrybased reporting option for the 2012
Physician Quality Reporting System and
beyond.
(B) 2012 Qualification Requirements for
Registries
Although we proposed to establish
the registry-based reporting mechanism
as a way to report Physician Quality
Reporting System quality measures for
2012 and beyond, we proposed (76 FR
42843 through 42845) the following
qualification requirements only apply
for the 2012 program year. For the
Physician Quality Reporting System in
2012, as in prior program years, we
proposed to require a self-nomination
process for registries wishing to submit
Physician Quality Reporting System
quality measures or measures groups on
behalf of eligible professionals for
services furnished during the applicable
reporting periods in 2012. This
qualification process allows us to ensure
that registries are fully informed of the
Physician Quality Reporting System
reporting process and to ensure the
registry is qualified, thereby improving
the likelihood of accurate reporting.
We note that third party
intermediaries may participate in
various capacities under the Physician
Quality Reporting System. In addition,
in an effort to encourage the electronic
submission of quality measures data
from eligible professionals’ EHRs, we
proposed EHR-based reporting, as
discussed later in this section. As a
result, we believe it is important to
distinguish entities that collect their
data from an EHR from those entities
that collect their data from other
sources. As such, as discussed here and
later in this section, we proposed, the
following two categories of third party
intermediaries that would be able to
submit Physician Quality Reporting
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System measures data on behalf of
eligible professional: (1) a registry, as
defined at 42 CFR 414.90(b), which
would be any data submission vendor
submitting data from a source other than
an EHR on behalf of eligible
professionals that meets the proposed
registry qualification requirements later
in this section; and (2) EHR data
submission vendors, which would be a
data submission vendor that obtains its
data from an eligible professional’s EHR
and that meets the 2012 EHR
qualification requirements. However, for
operational reasons, we may reserve the
right to limit such entities to a single
role such that the entity would need to
decide whether it wants to serve as a
registry or EHR data submission vendor
but not both. We note that a registry
could serve as an ‘‘EHR data submission
vendor’’ to the extent that it obtains data
from an eligible professional’s EHR, but
would need to meet the proposed 2012
EHR qualification requirements. To be
considered a qualified registry for
purposes of serving as a registry under
the program and submitting individual
quality measures on behalf of eligible
professionals who choose the registry
reporting mechanism for 2012, we
proposed that both registries new to the
Physician Quality Reporting System and
those previously qualified must:
• Be in existence as of January 1,
2012.
• Have at least 25 participants by
January 1, 2012.
• Provide at least 1 feedback report,
based on the data submitted to them for
the 2012 Physician Quality Reporting
System incentive reporting period, but if
technically feasible, provide at least 2
feedback reports throughout the year to
participating eligible professionals.
Although it is not a requirement that
registries provide interim feedback
reports, we believe it is in the
stakeholder’s interest to require early
registry collection of data for purposes
of providing a feedback report to eligible
professionals before the end of the 2012
Physician Quality Reporting System
incentive reporting period to determine
what steps, if any, an eligible
professional should take or may rectify
to meet the criteria for satisfactory
reporting.
• For purposes of distributing
feedback reports to eligible
professionals, collect an eligible
professional’s email addresses and have
documentation from the eligible
professional authorizing the release of
his or her email address.
• Not be owned and managed by an
individual locally-owned singlespecialty group (in other words, singlespecialty practices with only 1 practice
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location or solo practitioner practices
are prohibited from self-nominating to
become a qualified Physician Quality
Reporting System registry).
• Participate in ongoing 2012
Physician Quality Reporting System
mandatory support conference calls
hosted by CMS (approximately 1 call
per month), including an in-person
registry kick-off meeting to be held at
CMS headquarters in Baltimore, MD.
Registries that miss more than one
meeting will be precluded from
submitting Physician Quality Reporting
System data for the reporting year
(2012).
• Be able to collect all needed data
elements and transmit to CMS the data
at the TIN/NPI level for at least 3
measures, which is the minimum
amount of measures on which an
eligible professional is required to
report, in the 2012 Physician Quality
Reporting System (according to the
posted 2012 Physician Quality
Reporting System Measure
Specifications);
• Be able to calculate and submit
measure-level reporting rates or, upon
request, the data elements needed to
calculate the reporting rates by TIN/NPI.
• Be able to calculate and submit, by
TIN/NPI, a performance rate (that is, the
percentage of a defined population who
receive a particular process of care or
achieve a particular outcome based on
a calculation of the measure’s numerator
and denominator specifications) for
each measure on which the TIN/NPI
reports or, upon request the Medicare
beneficiary data elements needed to
calculate the performance rates.
• Be able to separate out and report
on Medicare Part B FFS patients.
• Provide the name of the registry.
• Provide the reporting period start
date the registry will cover.
• Provide the reporting period end
date the registry will cover.
• Provide the measure numbers for
the Physician Quality Reporting System
quality measures on which the registry
is reporting.
• Provide the measure title for the
Physician Quality Reporting System
quality measures on which the registry
is reporting.
• Report the number of eligible
instances (reporting denominator).
• Report the number of instances a
quality service is performed
(performance numerator).
• Report the number of performance
exclusions, meaning the quality action
was not performed for a valid reason as
defined by the measure specification.
• Report the number of reported
instances, performance not met (eligible
professional receives credit for
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reporting, not for performance),
meaning the quality action was not
performed for no valid reason as defined
by the measure specification.
• Be able to transmit this data in a
CMS-approved XML format.
• Comply with a CMS-specified
secure method for data submission,
such as submitting the registry’s data in
an XML file through an identity
management system specified by CMS
or another CMS-approved method, such
as use of appropriate Nationwide Health
Information Network specifications, if
technically feasible.
• Submit an acceptable ‘‘validation
strategy’’ to CMS by March 31, 2012. A
validation strategy ascertains whether
eligible professionals have submitted
accurately and on at least the minimum
number (80 percent) of their eligible
patients, visits, procedures, or episodes
for a given measure, which, as described
in section VI.F.1.e.2., is the minimum
percentage of patients on which an
eligible professional must report on any
given measure. Acceptable validation
strategies often include such provisions
as the registry being able to conduct
random sampling of their participant’s
data, but may also be based on other
credible means of verifying the accuracy
of data content and completeness of
reporting or adherence to a required
sampling method.
• Perform the validation outlined in
the strategy and send the results to CMS
by June 30, 2013 for the 2012 reporting
year’s data.
• Enter into and maintain with its
participating professionals an
appropriate Business Associate
agreement that provides for the
registry’s receipt of patient-specific data
from the eligible professionals, as well
as the registry’s disclosure of quality
measure results and numerator and
denominator data and/or patientspecific data on Medicare beneficiaries
on behalf of eligible professionals who
wish to participate in the Physician
Quality Reporting System.
• Obtain and keep on file signed
documentation that each holder of an
NPI whose data are submitted to the
registry has authorized the registry to
submit quality measure results and
numerator and denominator data and/or
patient-specific data on Medicare
beneficiaries to CMS for the purpose of
Physician Quality Reporting System
participation. This documentation must
be obtained at the time the eligible
professional signs up with the registry
to submit Physician Quality Reporting
System quality measures data to the
registry and must meet any applicable
laws, regulations, and contractual
business associate agreements.
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• Provide CMS access (upon request
for health oversight purposes like
validation) to review the Medicare
beneficiary data on which 2012
Physician Quality Reporting System
registry-based submissions are founded
or provide to CMS a copy of the actual
data (upon request).
• Provide CMS a signed, written
attestation statement via mail or email
which states that the quality measure
results and any and all data including
numerator and denominator data
provided to CMS are accurate and
complete.
• Use Physician Quality Reporting
System measure specifications and the
CMS provided measure calculation
algorithm, or logic, to calculate
reporting rates or performance rates
unless otherwise stated. CMS will
provide registries a standard set of logic
to calculate each measure and/or
measures group they intend to report in
2012.
• Provide a calculated result using
the CMS supplied measure calculation
logic and XML file for each measure that
the registry intends to calculate. The
registries will be required to show that
they can calculate the proper measure
results (that is, reporting and
performance rates) using the CMSsupplied logic and send the calculated
data back to CMS in the specified
format.
In addition to meeting all the
requirements specified previously for
the reporting of individual quality
measures via registry, for registries that
intend to report on 2012 Physician
Quality Reporting System measures
groups, we proposed that both registries
new to the Physician Quality Reporting
System and those previously qualified
must:
• Indicate the reporting period
chosen for each eligible professional
who chooses to submit data on
measures groups.
• Base reported information on
measures groups only on patients to
whom services were furnished during
the 2012 reporting period.
• Agree that the registry’s data may be
inspected or a copy requested by CMS
and provided to CMS under our
oversight authority.
• Be able to report consistent with the
reporting criteria requirements, as
specified in section IV.F.1.e.2.
We noted in the proposed rule that we
intended to post the final 2012
Physician Quality Reporting System
registry requirements on the Physician
Quality Reporting System section of the
CMS Web site at https://www.cms.gov/
pqrs by November 15, 2011 or shortly
thereafter. We anticipate that new
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registries that wish to self-nominate for
2012 would be required to do so by
January 31, 2012.
Furthermore, we proposed (76 FR
42845) that registries that were
‘‘qualified’’ for 2011 and wish to
continue to participate in 2012 will not
need to be ‘‘re-qualified’’ for 2012, but
instead are only required to demonstrate
that they can meet the new 2012 data
submission requirements. For technical
reasons, however, we did not expect to
be able to complete this vetting process
for the new 2012 data submission
requirements until mid-2012. Therefore,
for 2012, we indicated we may not be
able to post the names of registries that
are qualified for the 2012 Physician
Quality Reporting System until we have
determined the previously qualified
registries that wish to be qualified for
the 2012 Physician Quality Reporting
System are in compliance with the new
registry requirements.
We proposed that registries
‘‘qualified’’ for 2011, who are successful
in submitting 2011 Physician Quality
Reporting System data, and wish to
continue to participate in 2012 would
indicate their desire to continue
participation for 2012 by submitting a
self-nomination statement via a webbased tool to CMS indicating their
continued interest in being a Physician
Quality Reporting System registry for
2012 and their compliance with the
2012 Physician Quality Reporting
System registry requirements by no later
than October 31, 2011. Additionally,
registries that were qualified but
unsuccessful in submitting 2011
Physician Quality Reporting System
data (that is, fail to submit 2011
Physician Quality Reporting System
data per the 2011 Physician Quality
Reporting System registry requirements)
must go through a full self-nomination
vetting process for 2012.
We further proposed that by March
31, 2012, registries that are unsuccessful
at submitting registry data in the correct
data format for 2011 must be able to
meet the 2012 Physician Quality
Reporting System registry requirements
and go through the full vetting process
again. This would include CMS
receiving the registry’s self-nomination
by March 31, 2012. We proposed that
the aforementioned registry
requirements would also apply for the
purpose of a registry qualifying to
submit the electronic prescribing
measure for the 2012 eRx Incentive
Program. We anticipate finalizing the
list of 2012 Physician Quality Reporting
System registries by Summer 2012.
For eligible professionals considering
this reporting mechanism, we point out
that even though a registry is listed as
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‘‘qualified,’’ we cannot guarantee or
assume responsibility for the registry’s
successful submission of the required
Physician Quality Reporting System
quality measures results or measures
group results or required data elements
submitted on behalf of a given eligible
professional.
We invited public comments on the
proposed requirements to be considered
a qualified registry for purposes of the
2012 Physician Quality Reporting
System. We also sought comment on
disallowing previously-qualified
registries from submitting data on
Physician Quality Reporting System
quality measures in future years if it is
found that the data the registries
provide are found to be significantly
inaccurate (76 FR 42845). The following
is a summary of the comments received
regarding those proposals.
Comment: One commenter supported
our proposal to have registries and EHRs
(including both direct EHR-based
reporting and EHR data submission
vendors) provide at least two feedback
reports throughout the year to
participating eligible professionals, if
technically feasible.
Response: We appreciate the
commenter’s support and are finalizing
this requirement.
Comment: One commenter sought
clarification on the terms ‘‘needed data
elements.’’
Response: The type of data we are
referring to is the same type of data we
required in prior years; however, the
specific data elements will be addressed
in subsequent guidance. We anticipate
that the data elements will be similar to
the elements contained within the 2011
Physician Quality Reporting System
Registry XML Specifications which are
posted on the PQRS section of the CMS
Web site at https://www.cms.gov/PQRS/
20_AlternativeReporting
Mechanisms.asp#TopOfPage. This
information is made available within 4–
6 weeks of the publication of this final
rule to allow interested vendors the
opportunity to evaluate their systems for
the needed functionality and implement
any new capabilities as needed.
Comment: One commenter was
opposed to our requirement that
registries qualified for 2012 only report
on Medicare Part B FFS patients.
Response: We appreciate the
commenter’s feedback. However, as the
Physician Quality Reporting System is a
Medicare program, we would like to
concentrate the data we collect on data
that assesses the quality of care our
beneficiaries receive. Furthermore, since
we can only receive data on Medicare
beneficiaries via claims, which is
another reporting mechanism we are
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finalizing for 2012 and beyond, and we
are interested in collecting the same
type of data throughout each reporting
mechanism, we are finalizing the
requirement that registries only report
on Medicare Part B FFS patients.
Comment: One commenter was
opposed to our proposed vetting
timelines to qualify registries for the
2012 Physician Quality Reporting
System. The commenter urged us to
accelerate the qualification process for
registries.
Response: We appreciate the
commenter’s feedback. However, we
must allow sufficient time after the
publication of the qualification
requirements in this final rule with
comment period for vendors to decide if
they wish to participate in the Physician
Quality Reporting System and become
qualified. After self-nomination, we
attempt to allow ample time for vendors
to submit test files and resubmit them
if their first submission is unacceptable.
We would like to give every interested
vendor as much time to qualify as is
possible without delaying the
dissemination of this information (who
is a qualified vendor) to eligible
professionals who may wish to use one
of these systems or vendors to
participate in the Physician Quality
Reporting System.
Comment: Some commenters urged us
to post the list of qualified registries for
the Physician Quality Reporting System
prior to the start of the respective
program year. Some commenters also
asked that we post cost information.
Commenters believed that providing the
list of registries earlier, as well as
posting cost information, would help
eligible professionals make a more
informed decision with respect to
purchasing registries.
Response: We understand that it
would benefit eligible professionals to
have the list of qualified 2012 Physician
Quality Reporting System registries
available earlier. However, due to the
time it takes to vet registries for
qualification for the Physician Quality
Reporting System, we anticipate that we
will not be able to post the list of
qualified registries prior to the start of
the respective program year. However,
we will make every effort to post the list
of qualified registries for each respective
year as soon as possible. With respect to
posting registry cost information, upon
further consideration, we are not
posting cost information with our list of
qualified registries.
Comment: Although several
commenters supported our proposal to
add a the new EHR data submission
vendor classification, several
commenters opposed our proposal to
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limit entities that may qualify as both a
registry and EHR data submission
vendor to a single role such that the
entity would need to decide whether it
wants to serve as a registry or EHR data
submission vendor but not both. These
commenters stated that these entities
should be allowed to qualify as both
qualified registries and qualified EHR
data submission vendors.
Response: We appreciate the
commenters’ feedback and understand
that some entities who believe they
fulfill the qualification requirements for
both registries and EHR data submission
vendors desire to be qualified for
reporting under the Physician Quality
Reporting System as both. However, we
believe this requirement is necessary to
separate vendors qualifying as registries
and EHR data submission vendors, and
therefore, we are finalizing this
requirement.
Comment: One commenter supported
the idea of disqualifying registries that
submit inaccurate data in future
program years. Although one
commenter was not opposed to
disqualifying registries that submit
inaccurate information in future
program years, the commenter noted
that we should allow for reporting errors
that are outside a registry’s control.
Response: We are aware of many of
the issues registries encounter during
the collection of data they receive from
the eligible professionals for whom they
provide services. However, we do, as
part of its vetting process, require
registries to attest to the accuracy of
their data and have a validation process
in place to ensure the data is complete
and accurate. As we move towards
implementing the Value-Based
Modifier, the collection of accurate data
will become increasingly important. We
anticipate adopting in future rulemaking
the option of disqualifying a registry
from future Physician Quality Reporting
System reporting if their data is
inaccurate for future years of the
program. Details about this option,
including the basis for disqualifying a
registry for submission of inaccurate
data, will be addressed in future
rulemaking.
Based on the comments received and
for the reasons explained previously, we
are finalizing the proposed requirements
that registries must complete in order to
be ‘‘qualified’’ for 2012. Although we
proposed the use of a web-based tool,
but it has not yet been developed to
handle self-nomination requests;
therefore, we are finalizing submission
of this self-nomination statement via a
letter to CMS.
As we indicated, we anticipate
finalizing the list of 2012 Physician
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Quality Reporting System registries by
Summer 2012. We understand that it
would benefit eligible professionals to
have the list of qualified 2012 Physician
Quality Reporting System registries
available earlier. However, due to the
time it takes to vet these registries, we
may not be able to finalize and post the
list of 2012 Physician Quality Reporting
System registries until Summer 2012.
(3) EHR-Based Reporting
For 2012 and beyond, we proposed
(76 FR 42846) that eligible professionals
who choose to participate in the
Physician Quality Reporting System via
the EHR-based reporting mechanism
have the option of submitting quality
measure data obtained from their
Physician Quality Reporting System
qualified EHR to CMS either: (1)
Directly from his or her qualified EHR,
in the CMS-specified manner, or (2)
indirectly from a qualified EHR data
submission vendor (on the eligible
professional’s behalf), in the CMSspecified manner. We invited but
received no public comments on our
proposal to allow for EHR-based
reporting for 2012 and beyond via a
qualified direct EHR-based reporting or
qualified EHR data submission vendor.
Therefore, we are finalizing our
proposal to allow eligible professionals
to submit quality measure data obtained
from their Physician Quality Reporting
System qualified EHR to CMS either: (1)
Directly from his or her qualified EHR,
in the CMS-specified manner or (2)
indirectly from a qualified EHR data
submission vendor (on the eligible
professional’s behalf), in the CMSspecified manner.
(A) Direct EHR-Based Reporting
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(i) Requirements for the Direct EHRBased-Reporting Mechanism—
Individual Eligible Professionals
For 2012 and beyond, we proposed to
retain the EHR-based reporting
mechanism via a qualified EHR (as
defined in section VI.F.1.d.(3).(b)) for
the purpose of satisfactorily reporting
Physician Quality Reporting System
quality measures. We proposed the
following requirements for individual
eligible professionals associated with
EHR-based reporting: (1) Selection of a
Physician Quality Reporting System
qualified EHR product and (2)
submission of Medicare clinical quality
data extracted from the EHR directly to
CMS, in the CMS-specified manner.
We proposed (76 FR 42846) that, in
addition to meeting the appropriate
criteria for satisfactory reporting of
individual measures for the 2012
Physician Quality Reporting System
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EHR reporting option, eligible
professionals who choose the EHRbased reporting mechanism for the 2012
Physician Quality Reporting System
would be required to have a Physician
Quality Reporting System qualified EHR
product. We understand that eligible
professionals may have purchased
Certified EHR Technology for purposes
of reporting under the Medicare and
Medicaid EHR Incentive Programs. Such
Certified EHR Technology may or may
not be qualified for purposes of the 2012
Physician Quality Reporting System.
Eligible professionals would need to
ensure that their Certified EHR
Technology is also qualified for
purposes of the 2012 Physician Quality
Reporting System to participate in the
Physician Quality Reporting System via
the EHR-based reporting mechanism for
2012.
For 2012, we proposed to modify the
current list of EHR vendors qualified
under the Physician Quality Reporting
System to indicate which of the
qualified vendors’ products have also
received a certification for the purposes
of the EHR Incentive Programs.
We invited public comment on the
2012 proposed qualifications for direct
EHR-based reporting. The following is a
summary of the comments we received
regarding these proposals.
Comment: Some commenters were
opposed to our requirement that
Certified EHR Technology must also be
qualified for purposes of reporting 2012
Physician Quality Measures. Therefore,
one commenter opposed all
requirements for EHR qualification that
did not align with the requirements for
Certified EHR Technology. One
commenter stated that eligible
professionals should not have the added
burden of having to determine which
Certified EHR Technology systems are
also qualified for purposes of reporting
2012 Physician Quality Reporting
System measures.
Response: We appreciate the
commenters’ feedback. However, at this
time, it is not technically feasible to
automatically qualify Certified EHR
Technology to report 2012 Physician
Quality Reporting System measures. As
we stated in the proposed rule (76 FR
42846), the certification process for EHR
technology does not test the EHR
product’s ability to output a file that
meets the Physician Quality Reporting
System measures file specifications. We
are currently exploring ways to further
align these two programs’ reporting
requirements for future years so that
Certified EHR Technology may be used
to satisfy both the Medicare EHR
Incentive Program and the Physician
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Quality Reporting System without any
additional testing.
For the reasons stated previously, we
are finalizing these requirements for
individual eligible professionals
choosing the direct EHR-based
reporting-based reporting mechanism.
We anticipate that testing for qualified
direct EHR-based reporting products
will occur in late 2012, immediately
followed by the submission of the
eligible professional’s actual 2012
Physician Quality Reporting System
data in early 2013. This entire final test/
production data submission timeframe
for 2012 is expected to be December
2012 through February 2013. We are
currently vetting newly self-nominated
EHR vendor products for possible
qualification for the 2012 Physician
Quality Reporting System program year.
Similar to prior years, we expect to list
the 2012 Physician Quality Reporting
System qualified EHR products by
January 2012.
(ii) 2012 Qualification Requirements for
Direct EHR-Based Reporting Products
For EHR-based reporting products to
be qualified to be used to directly report
2012 Physician Quality Reporting
System quality measures data on behalf
of eligible professionals, we proposed
(76 FR 42846) that a test of quality data
submission from eligible professionals
who wish to report 2012 quality
measure data directly from their
qualified EHR product would be
required.
For EHR-based reporting vendors
wishing to qualify EHR products for
participation in the 2012 Physician
Quality Reporting System-Medicare
Incentive Pilot for the Medicare EHR
Incentive Program (discussed in section
VI.H. of this final rule with comment
period), we proposed (76 FR 42846) a
separate, accelerated vetting process for
EHR vendors and their products. This
vetting process would be the same
process as the vetting process for EHR
vendor products for the 2012 Physician
Quality Reporting System that is
currently underway. We will begin the
vetting process for these additional EHR
vendors and their products in the
beginning of 2012 and anticipate that
the vetting process be completed by
Summer/Fall 2012.
We further proposed that any EHR
vendor interested in having one or more
of their products being ‘‘qualified’’ to
submit quality data extracted from an
EHR to CMS on eligible professionals’
behalf for the 2012 Physician Quality
Reporting System would be required to
self-nominate. We anticipate that the
self-nomination deadline will occur no
later than December 31, 2011. We
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expect to post instructions for selfnomination by the 4th quarter of CY
2011 on the Physician Quality Reporting
System section of CMS Web site.
We invited public comment on the
proposed 2012 qualification
requirements for EHR products capable
of directly reporting. The following is a
summary of the comments we received
regarding this proposal.
Comment: One commenter was
opposed to our proposed vetting
timelines to qualify EHRs for the 2012
Physician Quality Reporting System.
The commenter urged us to accelerate
the process to qualify EHR systems.
Response: We appreciate the
commenter’s feedback. However, we
must allow sufficient time after the
publication of the qualification
requirements in this final rule with
comment period for vendors to decide if
they wish to participate in the Physician
Quality Reporting System and become
qualified. After self-nomination, we
attempt to allow ample time for vendors
to submit test files and resubmit them
if their first submission is unacceptable.
We would like to give every interested
vendor as much time to qualify as is
possible without delaying the
dissemination of this information (who
is a qualified vendor) to eligible
professionals who may wish to use one
of these systems or vendors to
participate in the Physician Quality
Reporting System.
Comment: Some commenters urged us
to align our EHR qualification
requirements with the requirements
needed to become Certified EHR
Technology under the EHR Incentive
Program.
Response: We agree with the
recommendation to align the EHR
Incentive Program with the Physician
Quality Reporting System, particularly
with respect to reporting clinical quality
measure results under the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot discussed in the
following section VI.H. of this final rule
with comment period. We are also
exploring ways to align the format for
receiving the measures data used by
both programs.
Comment: One commenter was
opposed to all qualification
requirements for EHRs (including both
direct EHR-based reporting and EHR
data submission vendors) that exceed
the requirements to become Certified
EHR Technology (which is the EHR
technology used in the EHR Incentive
Program).
Response: We are unsure of the
specific objection the commenter is
expressing with respect to EHR
requirements. CMS only requires EHR
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vendors who desire to have their
products directly submit quality
measure data to CMS for the Physician
Quality Reporting System to undergo a
vetting and testing process in order to
determine if the product(s) can properly
directly submit data to CMS. This
testing process will help to provide
more certainty for an eligible
professional who is relying on their
software to participate in the Physician
Quality Reporting System. Without this
testing, we believe there would be a risk
of a given product not being able to
export the quality data in the format that
CMS can receive and process it.
Based on the comments received and
for the reasons stated above, we are
finalizing the qualification requirements
as proposed for direct EHR products.
(B) EHR Data Submission Vendors
(i) Requirements for the EHR Data
Submission Vendor-Based Reporting
Mechanism—Individual Eligible
Professionals
For 2012 and beyond, we proposed
(76 FR 42846) a second EHR-based
reporting mechanism via a qualified
EHR data submission vendor (as defined
in 42 CFR 414.90(b)) for the purpose of
satisfactorily reporting Physician
Quality Reporting System quality
measures. We proposed the following
requirements for individual eligible
professionals associated with indirect
EHR-based reporting-based reporting:
(1) Selection of a Physician Quality
Reporting System qualified EHR data
submission vendor and (2) submission
of Medicare clinical quality data
extracted from the EHR to a qualified
‘‘EHR data submission vendor’’ (which
may include some current registries,
EHR vendors, and other entities that are
able to receive and transmit clinical
quality data extracted from an EHR) to
CMS, in the CMS-specified manner. For
eligible professionals who choose to
electronically submit Medicare clinical
quality data extracted from their EHR to
a qualified EHR data submission
vendor, the EHR data submission
vendor would then submit the
Physician Quality Reporting System
measures data to CMS in a CMSspecified manner on the eligible
professional’s behalf for the respective
program year.
For 2012, we proposed that in order
for an eligible professional to submit
Medicare clinical quality data extracted
from his or her EHR to CMS via an EHR
data submission vender, the eligible
professional must enter into and
maintain an appropriate legal
arrangement with a qualified 2012 EHR
data submission vendor that is capable
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of receiving and transmitting Medicare
clinical quality data extracted from an
EHR. Such arrangements would provide
for the EHR data submission vendor’s
receipt of beneficiary-specific data from
the eligible professional and the EHR
data submission vendor’s disclosure of
the beneficiary-specific data on behalf of
the eligible professional to CMS. Thus,
the EHR data submission vendor would
act as a Health Insurance Portability and
Accountability Act of 1996 (Pub. L.
104–191) (HIPAA) Business Associate
and agent of the eligible professional.
Such agents are referred to as ‘‘EHR data
submission vendors.’’ The ‘‘EHR data
submission vendors’’ would have the
requisite legal authority to provide
beneficiary-specific data on the 2012
Physician Quality Reporting System
EHR measures on behalf of the eligible
professional to CMS for the Physician
Quality Reporting System.
We also proposed that eligible
professionals choosing to participate in
the 2012 Physician Quality Reporting
System through the EHR-based
reporting mechanism via an EHR data
submission vendor for 2012 must select
a qualified Physician Quality Reporting
System EHR data submission vendor
and submit information on Physician
Quality Reporting System EHR
measures to the selected EHR data
submission vendor in the form and
manner, and by the deadline specified
by the EHR data submission vendor.
We invited but received no public
comments on the proposed
requirements for individual eligible
professionals using EHR data
submission vendors to submit Physician
Quality Reporting System quality
measures data. Therefore, we are
finalizing the 2012 qualification
requirements as proposed for individual
eligible professionals using EHR data
submission vendors to submit Physician
Quality Reporting System quality
measures data.
We will also be vetting those selfnominated EHR data submission
vendors for possible qualification to
submit 2012 Physician Quality
Reporting System measures on eligible
professionals’ behalf under the EHRbased reporting mechanism. We expect
to list the entities that are EHR data
submission vendors qualified to submit
2012 Physician Quality Reporting
System EHR measures on eligible
professionals’ behalf by mid-2012.
Please note that we cannot assume
responsibility for the successful
submission of data from eligible
professionals’ EHRs. In addition,
eligible professionals who decide to
submit the Physician Quality Reporting
System measures directly from his or
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her EHR should begin attempting
submission soon after the opening of the
clinical data warehouse in order to
assure the eligible professional has a
reasonable period of time to work with
his or her EHR and/or its vendors to
correct any problems that may
complicate or preclude successful
quality measures data submission
through that EHR.
(ii) 2012 Qualification Requirements for
EHR Data Submission Vendors
Similar to our 2012 qualification
requirements for vendors that provide
EHR products that are qualified as being
capable of directly reporting, we
proposed that qualified EHR data
submission vendors that wish to submit
2012 quality measures data obtained
from an eligible professional’s qualified
EHR product to CMS on the eligible
professional’s behalf would have to
meet certain 2012 qualification
requirements, explained in detail the
proposed rule (76 FR 42847).
We invited public comment on the
proposed qualification requirements on
the 2012 for EHR data submission
vendors who wish to submit Physician
Quality Reporting System quality
measures data. Please note that some of
the issues raised by commenters
regarding the 2012 qualification
requirements for registries, which were
addressed previously, were similar or
the same as those raised about the
qualification requirements for EHR data
submission vendors. Therefore, we
addressed many of those issues
previously. The following is a summary
of the comments we received regarding
these ERH data submission vendor
proposals.
Comment: One commenter was
opposed to our proposed timelines to
qualify EHRs for the 2012 Physician
Quality Reporting System. The
commenter urged that we accelerate the
process to qualify EHRs for the 2012
Physician Quality Reporting System to
provide earlier notice to eligible
professionals as to which EHR vendors
have been qualified.
Response: We appreciate the
commenter’s feedback. However, we
must allow sufficient time after the
publication of the qualification
requirements in this final rule with
comment period for vendors to decide if
they wish to participate in the Physician
Quality Reporting System and become
qualified. After self-nomination, we
attempt to allow ample time for vendors
to submit test files and resubmit them
if their first submission is unacceptable.
We would like to give every interested
vendor as much time to qualify as is
possible without delaying the
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dissemination of this information (who
is a qualified vendor) to eligible
professionals who may wish to use one
of these systems or vendors to
participate in the Physician Quality
Reporting System.
Comment: Some commenters urged us
to align our EHR qualification
requirements (for both direct EHR-based
reportingand EHR data submission
vendors) with the requirements needed
to become Certified EHR Technology
under the EHR Incentive Program.
Response: We agree with the
recommendation to align the EHR
Incentive Program with the Physician
Quality Reporting System, particularly
with respect to reporting clinical quality
measure results under the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot discussed in section
VI.F.4. of this final rule with comment
period. We are also exploring ways to
align the format for receiving the
measures data used by both programs.
Based on the comments received and
for the reasons stated above, we are
finalizing the 2012 qualification
requirements as proposed for EHR data
submission vendors who wish to submit
Physician Quality Reporting System
quality measures data.
EHR data submission vendors that
wish to submit 2012 quality measures
data obtained from an eligible
professional’s EHR product to CMS on
the eligible professional’s behalf must
submit test data in late 2012 followed by
the submission of the eligible
professional’s actual 2012 Physician
Quality Reporting System data in early
2013.
For data submission vendors wishing
to qualify for participation in the 2012
Physician Quality Reporting SystemMedicare Incentive Pilot for the
Medicare EHR Incentive Program
(discussed in section VI.H. of this final
rule with comment period), these data
submission vendors must undergo a
separate, accelerated vetting process for
EHR data submission vendors. Although
the requirements for becoming a
qualified EHR data submission vendor
are different than becoming a qualified
EHR product for direct EHR-based
reporting, the vetting process will be the
same process as the vetting process for
EHR vendor products for the 2012
Physician Quality Reporting System that
is currently underway. We will begin
the vetting process for these EHR data
submission vendors in the beginning of
2012 and anticipate that the vetting
process will be completed by Summer/
Fall 2012.
Any EHR data submission vendor
interested in being ‘‘qualified’’ to submit
quality data extracted from an EHR to
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73325
CMS on eligible professionals’ behalf for
the 2012 Physician Quality Reporting
System is required to self-nominate. We
anticipate that the self-nomination
deadline will occur no later than
December 31, 2011. We expect to post
instructions for self-nomination by the
4th quarter of CY 2011 on the Physician
Quality Reporting System section of
CMS Web site.
EHR data submission vendors who
wish to submit 2012 Physician Quality
Reporting System quality measure data
must also meet the following
qualification requirements:
• Not be in a beta test form.
• Be in existence as of January 1,
2012
• Have at least 25 active users.
• Participate in ongoing Physician
Quality Reporting mandatory support
conference calls hosted by CMS
(approximately one call per month).
Failure to attend more than one call per
year would result in the removal of the
EHR data submission vendor from the
2012 EHR qualification process.
• Have access to the identity
management system specified by CMS
(such as, but not limited to, the
Individuals Authorized Access to CMS
Computer Systems, or IACS) to submit
clinical quality data extracted to a CMS
clinical data warehouse.
• Submit a test file containing
dummy Medicare clinical quality data
to a CMS clinical data warehouse via an
identity management system specified
by CMS during a timeframe specified by
CMS. In 2011, the requirement to
submit a test file could have contained
real or dummy data. However, for
privacy reasons, we have decided to
only provide for the submission of test
files containing dummy data. We have
finalized revisions to 42 CFR 414.90 to
reflect this change.
• Submit a file containing the eligible
professional’s 2012 Physician Quality
Reporting System Medicare clinical
quality data extracted from the EHR for
the entire 12-month reporting period via
the CMS-specified identify management
system during the timeframe specified
by us in early 2013.
• Provide at least 1 feedback report,
based on the data submitted to them for
the 2012 Physician Quality Reporting
System incentive reporting period, but if
technically feasible, provide at least 2
feedback reports throughout the year to
participating eligible professionals.
• Be able to collect all needed data
elements and transmit to CMS the data
at the beneficiary level.
• Be able to separate out and report
on Medicare Part B FFS patients.
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• Provide the measure numbers for
the quality measures on which the data
submission vendor is reporting.
• Be able to transmit this data in a
CMS-approved XML format utilizing a
Clinical Document Architecture (CDA)
standard such as Quality Reporting Data
Architecture (QRDA).
• Comply with a CMS-specified
secure method for data submission,
such as submitting the EHR data
submission vendor’s data in an XML file
through an identity management system
specified by CMS or another approved
method, such as use of appropriate
Nationwide Health Information Network
specifications, if technically feasible.
• Enter into and maintain with its
participating professionals an
appropriate Business Associate
agreement that provides for the data
submission vendor’s receipt of patientspecific data from the eligible
professionals, as well as the data
submission vendor’s disclosure of
patient-specific data on Medicare
beneficiaries on behalf of eligible
professionals who wish to participate in
the Physician Quality Reporting System.
• Obtain and keep on file signed
documentation that each holder of an
NPI whose data are submitted to the
data submission vendor has authorized
the data submission vendor to submit
patient-specific data on Medicare
beneficiaries to CMS for the purpose of
Physician Quality Reporting System
participation. This documentation must
be obtained at the time the eligible
professional signs up with the data
submission vendor to submit Physician
Quality Reporting System quality
measures data to the data submission
vendor and must meet any applicable
laws, regulations, and contractual
business associate agreements.
• Provide CMS access (upon request
for health oversight purposes like
validation) to review the Medicare
beneficiary data on which 2012
Physician Quality Reporting System
EHR-based submissions are founded or
provide to CMS a copy of the actual data
(upon request).
• Provide CMS a signed, written
attestation statement via mail or email
which states that the quality measure
results and any and all data including
numerator and denominator data
provided to CMS are accurate and
complete.
• Use Physician Quality Reporting
System measure specifications and the
CMS provided measure calculation
algorithm, or logic, to calculate
reporting rates or performance rates
unless otherwise stated. CMS will
provide EHR data submission vendors a
standard set of logic to calculate each
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measure and/or measures group they
intend to report in 2012.
• Provide a calculated result using
the CMS supplied measure calculation
logic and XML file for each measure that
the EHR data submission vendor
intends to calculate. The data
submission vendors will be required to
show that they can calculate the proper
measure results (that is, reporting and
performance rates) using the CMSsupplied logic and send the calculated
data back to CMS in the specified
format.
For EHR data submission vendors
participating in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot for 2012 (discussed in
section VI.H. of this final rule with
comment period) and wish to also
submit Medicare clinical quality data
extracted from an EHR for the purposes
of the 2012 Physician Quality Reporting
System incentive, these EHR data
submission vendors must meet the
following requirements in addition to
the requirements stated previously:
• Be able to collect all needed data
elements and transmit to CMS the data
at the TIN/NPI level.
• Be able to calculate and submit
measure-level reporting rates or, upon
request, the data elements needed to
calculate the reporting rates by TIN/NPI.
• Be able to calculate and submit, by
TIN/NPI, a performance rate (that is, the
percentage of a defined population who
receive a particular process of care or
achieve a particular outcome based on
a calculation of the measure’s numerator
and denominator specifications) for
each measure on which the TIN/NPI
reports or, upon request the Medicare
beneficiary data elements needed to
calculate the reporting rates.
• Report the number of eligible
instances (reporting denominator).
• Report the number of instances a
quality service is performed (reporting
numerator).
• Report the number of performance
exclusions, meaning the quality action
was not performed for a valid reason as
defined by the measure specification.
• Report the number of reported
instances, performance not met (eligible
professional receives credit for
reporting, not for performance),
meaning the quality action was not
performed for no valid reason as defined
by the measure specification.
• Be able to transmit this data in a
CMS-approved XML format.
• Submit an acceptable ‘‘validation
strategy’’ to CMS by March 31, 2012. A
validation strategy ascertains whether
eligible professionals have submitted
accurately and on at least the minimum
number (80 percent) of their eligible
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patients, visits, procedures, or episodes
for a given measure, which, as described
in section VI.F.1.e.2. of this final rule
with comment period, is the minimum
percentage of patients on which an
eligible professional must report on any
given measure. Acceptable validation
strategies often include such provisions
as the EHR data submission vendor
being able to conduct random sampling
of their participant’s data, but may also
be based on other credible means of
verifying the accuracy of data content
and completeness of reporting or
adherence to a required sampling
method.
• Perform the validation outlined in
the strategy and send the results to CMS
by June 30, 2013 for the 2012 reporting
year’s data.
• Enter into and maintain with its
participating professionals an
appropriate Business Associate
agreement that provides for the data
submission vendor’s receipt of patientspecific data from the eligible
professionals, as well as the data
submission vendor’s disclosure of
quality measure results and numerator
and denominator data on Medicare
beneficiaries on behalf of eligible
professionals who wish to participate in
the Physician Quality Reporting System.
• Obtain and keep on file signed
documentation that each holder of an
NPI whose data are submitted to the
data submission vendor has authorized
the data submission vendor to submit
quality measure results and numerator
and denominator data on Medicare
beneficiaries to CMS for the purpose of
Physician Quality Reporting System
participation. This documentation must
be obtained at the time the eligible
professional signs up with the data
submission vendor to submit Physician
Quality Reporting System quality
measures data to the data submission
vendor and must meet any applicable
laws, regulations, and contractual
business associate agreements.
• Use Physician Quality Reporting
System measure specifications and the
CMS provided measure calculation
algorithm, or logic, to calculate
reporting rates or performance rates
unless otherwise stated.
• Provide a calculated result using
the CMS supplied measure calculation
logic and XML file for each measure that
the EHR data submission vendor
intends to calculate. The data
submission vendors are required to
show that they can calculate the proper
measure results (that is, reporting and
performance rates) using the CMSsupplied logic and send the calculated
data back to CMS in the specified
format.
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For 2012, the EHR data submission
vendor must submit clinical quality data
on Medicare beneficiaries extracted
from eligible professionals’ EHRs to our
designated database for the Physician
Quality Reporting System using a CMSspecified record layout, which will be
provided to the EHR data submission
vendor by CMS. In addition, for
purposes of also reporting 2012
Physician Quality Reporting System
quality measures, the EHR data
submission vendor must to submit
patient level Medicare clinical quality
data extracted from the eligible
professional’s EHR using the same CMSspecified record layout that qualified
EHR products must be able to produce
for purposes of an eligible professional
directly submitting the 2012 Physician
Quality Reporting System EHR
measures to CMS.
(C) Qualification Requirements for
Direct EHR-Based Reporting Data
Submission Vendors and Their Products
for the 2013 Physician Quality
Reporting System
As in prior years, unlike the
qualification process for registries, EHR
vendors, which include vendors that
provide EHR products that qualify for
direct EHR-based reporting and EHR
data submission vendors, are tested for
qualification a year ahead of the
program year in which the EHR vendor
intends to submit Physician Quality
Reporting System quality measures on
behalf of individual eligible
professionals or where its product(s) are
available for use by eligible
professionals to submit Physician
Quality Reporting System measures
directly to CMS.
We proposed EHR vendor testing for
the 2013 Physician Quality Reporting
System program year to qualify new
EHR vendors and EHR data submission
vendors and their EHR products for
submission of Medicare beneficiary
quality data extracted from EHR
products to the CMS Medicare clinical
quality data warehouse for the 2013
Physician Quality Reporting System.
In order for EHR vendors to be
qualified to report 2013 Physician
Quality Reporting System data to CMS,
we proposed that EHR vendors would
be required to meet the following
requirements:
• Not be in a beta test form.
• Be in existence as of January 1,
2012.
• Have at least 25 active users.
• Participate in ongoing Physician
Quality Reporting mandatory support
conference calls hosted by CMS
(approximately one call per month).
Failure to attend more than one call per
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year would result in the removal of the
EHR data submission vendor from the
2012 EHR qualification process.
• Indicate the reporting option the
vendor seeks to qualify for its users to
submit in addition to individual
measures.
• Have access to the identity
management system specified by CMS
(such as, but not limited to, the
Individuals Authorized Access to CMS
Computer Systems, or IACS) to submit
Medicare clinical quality data extracted
to a CMS clinical data warehouse.
• Submit a test file containing
dummy Medicare clinical quality data
to a CMS clinical data warehouse via an
identity management system specified
by CMS during a timeframe specified by
CMS. In 2011, the requirement to
submit a test file could have contained
real or dummy data. However, for
privacy reasons, we have decided to
only provide for the submission of test
files containing dummy data. We
proposed revisions to 42 CFR 414.90 to
reflect this change.
• Submit a file containing the eligible
professional’s 2012 Physician Quality
Reporting System Medicare clinical
quality data extracted from the EHR for
the entire 12-month reporting period via
the CMS-specified identify management
system during the timeframe specified
by us in early 2013.
• Provide at least 1 feedback report,
based on the data submitted to them for
the 2012 Physician Quality Reporting
System incentive reporting period, and
if technically feasible, provide at least
two feedback reports throughout the
year to participating eligible
professionals.
• Be able to collect all needed data
elements and transmit to CMS the data
at the beneficiary level.
• Be able to separate out and report
on Medicare Part B FFS patients.
• Provide the measure numbers for
the quality measures on which the data
submission vendor is reporting.
• Be able to transmit this data in a
CMS-approved XML format utilizing a
Clinical Document Architecture (CDA)
standard such as Quality Reporting Data
Architecture (QRDA).
• Comply with a CMS-specified
secure method for data submission,
such as submitting the EHR vendor’s
data in an XML file through an identity
management system specified by CMS
or another approved method, such as
use of appropriate Nationwide Health
Information Network specifications, if
technically feasible.
• Enter into and maintain with its
participating professionals an
appropriate Business Associate
agreement that provides for the data
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submission vendor’s receipt of patientspecific data from the eligible
professionals, as well as the data
submission vendor’s disclosure of
patient-specific data on Medicare
beneficiaries on behalf of eligible
professionals who wish to participate in
the Physician Quality Reporting System.
• Obtain and keep on file signed
documentation that each holder of an
NPI whose data are submitted to the
data submission vendor has authorized
the data submission vendor to submit
patient-specific data on Medicare
beneficiaries to CMS for the purpose of
Physician Quality Reporting System
participation. This documentation must
be obtained at the time the eligible
professional signs up with the data
submission vendor to submit Physician
Quality Reporting System quality
measures data to the data submission
vendor and must meet any applicable
laws, regulations, and contractual
business associate agreements.
• Provide CMS access (upon request
for health oversight purposes like
validation) to review the Medicare
beneficiary data on which 2012
Physician Quality Reporting System
EHR-based submissions are founded or
provide to CMS a copy of the actual data
(upon request).
• Provide CMS a signed, written
attestation statement via mail or email
which states that the quality measure
results and any and all data including
numerator and denominator data
provided to CMS are accurate and
complete.
• Use Physician Quality Reporting
System measure specifications and the
CMS provided measure calculation
algorithm, or logic, to calculate
reporting rates or performance rates
unless otherwise stated. CMS would
provide EHR vendors a standard set of
logic to calculate each measure and/or
measures group they intend to report in
2012.
• Provide a calculated result using
the CMS supplied measure calculation
logic and XML file for each measure that
the EHR vendor intends to calculate.
The data submission vendors would be
required to show that they can calculate
the proper measure results (that is,
reporting and performance rates) using
the CMS-supplied logic and send the
calculated data back to CMS in the
specified format.
This is the same self-nomination
process described in the ‘‘Requirements
for Electronic Health Record (EHR)
Vendors to Participate in the 2012
Physician Quality Reporting System
EHR Program,’’ posted on the Physician
Quality Reporting System section of the
CMS Web site at https://www.cms.gov/
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PQRS/20_AlternativeReporting
Mechanisms.asp#TopOfPage. For 2013,
we proposed that these requirements
would apply not only for the purpose of
a vendor’s EHR product being qualified
so that the product’s users may submit
2013 Medicare beneficiary data
extracted from the EHR for the 2013
Physician Quality Reporting System in
2014, but also for the purpose of a
vendor’s EHR product being qualified to
electronically submit Medicare
beneficiary data extracted from the EHR
for reporting the electronic prescribing
measure for the eRx Incentive Program
2013 incentive and 2014 payment
adjustment. Similarly, we proposed that
these requirements would apply not
only for the purposes of an EHR data
submission vendor being qualified to
submit 2013 Medicare beneficiary data
from eligible professionals’ EHRs for the
2013 Physician Quality Reporting
System in 2014 but also for the purpose
of an EHR data submission vendor being
qualified to electronically submit
Medicare beneficiary data extracted
from the EHR for reporting the
electronic prescribing measure for the
eRx Incentive Program 2013 incentive
and 2014 payment adjustment.
We also proposed that if an EHR
vendor misses more than one mandatory
support call or meeting, the vendor and
their product and/or EHR data
submission vendor would be
disqualified for the Physician Quality
Reporting System reporting year, which
is covered by the call.
For the 2013 Physician Quality
Reporting System, we proposed that
previously qualified and new vendors
and/or EHR data submission vendors
would need to incorporate any new EHR
measures (that is, electronicallyspecified measures), as well as update
their electronic measure specifications
and data transmission schema should
either or both change, finalized for the
Physician Quality Reporting System for
2013 if they wish to maintain their
Physician Quality Reporting System
qualification.
We invited public comment related to
our proposed qualification requirements
for EHR direct and data submission
vendors and their products for the 2013
Physician Quality Reporting System.
The comments received regarding this
proposal have been addressed
previously.
Based on the comments received and
for the reasons previously stated, we are
finalizing the qualification requirements
for EHR direct and data submission
vendors and their products for the 2013
Physician Quality Reporting System.
Any EHR vendor interested in having
one or more of their EHR products
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‘‘qualified’’ to submit quality data
extracted from their EHR products to the
CMS Medicare clinical quality data
warehouse for the 2013 Physician
Quality Reporting System must submit
their self-nomination statement by
January 31, 2012. Whereas, in prior
program years, EHR vendors have
submitted self-nomination statements
via mail, we proposed to have EHR
vendors submit self-nomination
statements via a web-based tool, if
technically feasible for us to develop
such a tool. However, at this time, it is
not technically feasible to collect selfnomination statements via a web-based
tool. Therefore, as we proposed as an
alternative, we will accept selfnomination statements from EHR
vendors that wish to be qualified for the
2013 Physician Quality Reporting
System via email. We expect to post
instructions for submitting the selfnomination statement and the 2013 EHR
vendor requirements in the 4th quarter
of CY 2011. Specifically, for the 2013
Physician Quality Reporting System, in
order to ensure EHR vendors’ interest in
participating in the 2013 Physician
Quality Reporting System, only EHR
vendors that self-nominate by January
31, 2012 to participate in the EHR
Program testing during calendar year
2012 will be considered qualified EHR
vendors for the 2013 Physician Quality
Reporting System.
e. Incentive Payments for the 2012
Physician Quality Reporting System
In accordance with 42 CFR
414.90(c)(3), eligible professionals that
satisfactorily report 2012 Physician
Quality Reporting System measures can
qualify for an incentive equal to 0.5
percent of the total estimated part B
allowed charges for all covered
professional services furnished by the
eligible professional (or, in the case of
a group practice participating in the
GPRO, the group practice) during the
applicable reporting period. We
proposed (76 FR 42850) modifying the
incentive payment language in 42 CFR
414.90(c) so that the language is more
consistent with section 1848 of the Act.
We are finalizing this proposal. We are
also making technical changes to
renumber the clauses under 42 CFR
414.90(c).
(1) Criteria for Satisfactory Reporting of
Individual Quality Measures for
Individual Eligible Professionals via
Claims
Section 1848(m)(3)(A) of the Act
established the criteria for satisfactorily
submitting data on individual quality
measures as submitting data on at least
three measures in at least 80 percent of
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the cases in which the measure is
applicable. For claims-based reporting,
if fewer than three measures are
applicable to the services of the
professional, the professional may meet
the criteria by submitting data on one or
two measures for at least 80 percent of
applicable cases where the measures are
reportable. For years after 2009, section
1848(m)(3)(D) of the Act authorizes the
Secretary, in consultation with
stakeholders and experts, to revise the
criteria for satisfactorily reporting data
on quality measures.
Accordingly, we proposed (76 FR
42850) the following criteria for
satisfactory reporting via the claimsbased reporting mechanism for
individual eligible professionals
specializing in internal medicine, family
practice, general practice, or cardiology:
• Report on at least one Physician
Quality Reporting System core measure
as identified in Table 46 of this
proposed rule.
• Report on at least two additional
measures that apply to the services
furnished by the professional.
• Report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
We proposed the requirement of the
reporting of Physician Quality Reporting
System core measures for certain
specialties to introduce measures
reporting according to specialty for
eligible professionals specializing in
internal medicine, family practice,
general practice, or cardiology.
However, we did not propose this core
measure requirement for all other
specialties. Therefore, for all other
specialties, we proposed (76 FR 42851)
to retain similar reporting criteria as
finalized for the in the 2011 MPFS final
rule. Specifically, we proposed the
following criteria for satisfactory
reporting via the claims-based reporting
mechanism:
• Report on at least three measures
that apply to the services furnished by
the professional; and
• Report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
To the extent that an eligible
professional has fewer than three
Physician Quality Reporting System
measures that apply to the eligible
professional’s services and the eligible
professional is reporting via the claimsbased reporting mechanism, we
proposed (76 FR 42851) that the eligible
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professional would be able to meet the
criteria for satisfactorily reporting data
on individual quality measures by
meeting the following two criteria—
• Report on all measures that apply to
the services furnished by the
professional (that is one to two
measures); and
• Report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
As in prior years, we also proposed
(76 FR 42851) that, for 2012, an eligible
professional who reports on fewer than
three measures through the claimsbased reporting mechanism may be
subject to the Measure Applicability
Validation (MAV) process, which would
allow us to determine whether an
eligible professional should have
reported quality data codes for
additional measures. This process was
applied in prior years, including the
2011 Physician Quality Reporting
System. We proposed that these criteria
for satisfactorily reporting data on fewer
than three individual quality measures
would apply for the claims-based
reporting mechanism only because,
unlike registry and EHR-based
reporting, the reporting of Physician
Quality Reporting System quality
measures via claims is not handled by
an intermediary but rather directly by
the eligible professional.
For 2012, in order to encourage
reporting on measures that are
applicable to the eligible professional’s
practice as well as encourage eligible
professionals to perform the clinical
quality actions specified in the
measures, we proposed (76 FR 42851)
not to count measures that are reported
through claims that have a zero percent
performance rate. That is, if the
recommended clinical quality action, as
indicated in the numerator of the
quality measure, is not performed on at
least one patient for a particular
measure or measures group reported by
the eligible professional via claims, we
will not count the measure (or measures
group) as a measure (or measures group)
reported by an eligible professional.
This requirement is also consistent with
the registry and EHR-based reporting
criteria for satisfactory reporting in
section VI.F.1.e of this final rule with
comment period.
We invited and received public
comments on our proposed 2012 criteria
for satisfactory reporting of data on
individual Physician Quality Reporting
System quality measures for individual
eligible professionals via claims. We
also sought public comment as to
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whether geriatricians should be
included as a specialty required to
report on 2012 Physician Quality
Reporting System core measures. In
addition, we sought public comment on
whether other specialties should be
included in the 2012 Physician Quality
Reporting System core measure
reporting requirement. The following is
a summary of the comments we
received regarding these proposals.
Comment: Some commenters
supported our proposal to require the
reporting of the 2012 Physician Quality
Reporting System core measures. One
commenter asked whether nurse
practitioners and physician assistants
working in family practice, internal
medicine, general practice, and
cardiology would be required to report
on at least 1 Physician Quality
Reporting System core measure. Other
commenters suggested that we include
geriatricians as a specialty required to
report on at least 1 Physician Quality
Reporting System core measure,
whereas others did not. One commenter
suggested that hospitalists also be
required to report on the 2012 Physician
Quality Reporting System core
measures, whereas one commenter
stated that hospitalists cannot report on
the 2012 Physician Quality Reporting
System core measures.
Response: We appreciate the
commenters’ feedback and question. We
continue to recognize the importance of
and encourage reporting on these
Physician Quality Reporting System
core measures, which are aimed at
promoting cardiovascular care.
However, due to some operational
limitations, such as having insufficient
time to properly update our analysis
systems to check for an eligible
professional’s specialty, we are not
finalizing our proposed requirement
that physicians practicing in internal
medicine, family practice, general
practice, and cardiology report on at
least 1 Physician Quality Reporting
System core measure. Therefore, eligible
professionals specializing in these
specialties may still report on these
measures under the program, but are not
required to meet the proposed reporting
criterion regarding the core measures.
For purposes of earning a 2012
incentive, we are only finalizing the
claims based reporting criteria for
satisfactory reporting that we proposed
for all other individual eligible
professionals. Therefore, individual
eligible professionals practicing in
internal medicine, family practice,
general practice and cardiology must
meet that criterion for satisfactory
reporting for the claims-based
mechanism.
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Comment: Some commenters opposed
our proposal to require eligible
professionals practicing in internal
medicine, family practice, general
practice, and cardiology to report on the
2012 Physician Quality Reporting
System core measures as it posed an
additional reporting burden on these
eligible professionals.
Response: We appreciate the
commenters’ feedback but respectfully
disagree. As these measures are those
that we expect eligible professionals
practicing in internal medicine, family
practice, general practice, and
cardiology to report as they address high
priority care areas for eligible
professionals practicing in these
specialties, we do not believe requiring
these eligible professionals to report on
at least 1 2012 Physician Quality
Reporting System core measure would
have posed an additional reporting
burden on these eligible professionals.
However, as described previously, due
to operational limitations, we are not
finalizing this criterion for satisfactory
reporting and therefore, we are not
requiring these specialties to report on
the 2012 Physician Quality Reporting
System core measures. However, we
still encourage these specialties to
report on these Physician Quality
Reporting System core measures when
appropriate.
Comment: A few commenters
supported our proposal to lower the
reporting threshold from 80 to 50
percent of the eligible professional’s
Medicare Part B PFS patients seen
during the reporting period to which the
measure applies.
Response: We appreciate the
commenter’s feedback and are finalizing
this reporting threshold of 50 percent of
the eligible professional’s Medicare Part
B PFS patients seen during the reporting
period to which the measure applies for
claims-based reporting.
Comment: One commenter opposed
our proposal to not count measures
reported via claims with a zero percent
performance rate, because it is sufficient
that eligible professionals make the
effort to report Physician Quality
Reporting System measures.
Response: We appreciate the
commenter’s feedback. However, we are
interested in moving away from pro
forma reporting. We are interested in
concentrating on the collection of
meaningful data. Therefore, for the
reasons we stated previously, we are
finalizing our proposal to not count
measures reported via claims with a
zero percent performance rate.
Comment: One commenter opposed
our proposal to require eligible
professionals that report on less than 3
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satisfactory reporting of data on
individual Physician Quality Reporting
System quality measures via claims,
described in Table 40. As we indicate
above, Table 40 reflects the criteria for
satisfactory reporting of data on
Physician Quality Reporting System
quality measures via claims for all
eligible professionals.
based reporting mechanism: (1) criteria
for individual eligible professionals
practicing in internal medicine, family
practice, general practice, or cardiology
and (2) criteria for all other eligible
professionals. For the reasons stated
previously, we distinguished eligible
professionals in internal medicine,
family practice, general practice, or
cardiology from all other eligible
professionals for the purposes of
establishing criteria for satisfactory
reporting. Therefore, for eligible
professionals specializing in internal
medicine, family practice, general
practice, or cardiology, we proposed (76
FR 42852) the following criteria for
satisfactory reporting—
• Report on at least one Physician
Quality Reporting System core measure
as identified in Table 28 of the proposed
rule (76 FR 42863);
• Report on at least two additional
measures that apply to the services
furnished by the professional; AND
• Report each measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
For the same reasons stated for
establishing different reporting criteria
for all other eligible professionals under
the claims-based reporting mechanism,
we proposed the following criteria for
satisfactory reporting via the registrybased reporting mechanism—
• Report on at least three measures
that apply to the services furnished by
the professional; AND
• Report each measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
In addition, as in prior years, for 2012,
we proposed not to count measures that
are reported through registries that have
a zero percent performance rate,
calculated by dividing the measure’s
numerator by the measure’s
denominator. That is, if the
recommended clinical quality action,
that is the action denoted in the quality
measure’s numerator, is not performed
on at least one patient for a particular
measure or measures group reported by
the eligible professional via registry, we
will not count the measure (or measures
group) as a measure (or measures group)
reported by an eligible professional. We
proposed to disregard measures (or
measures groups) that are reported
through a registry that have a zero
percent performance rate in the 2012
Physician Quality Reporting System,
because we are assuming that the
measure was not applicable to the
eligible professional and was likely
reported from EHR-derived data (or
from data mining) and was
unintentionally submitted from the
registry to us. We also sought to avoid
the possibility of intentional submission
of spurious data solely for the purpose
(2) 2012 Criteria for Satisfactory
Reporting of Individual Quality
Measures for Individual Eligible
Professionals via Registry
Under our authority of section
1848(m)(3)(D) of the Act to revise the
reporting criteria for the satisfactory
reporting of measures, we proposed (76
FR 42852) the following criteria for
satisfactory reporting via the registry-
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ER28NO11.148</GPH>
of measures eligible professionals must
otherwise report). We believe it is
important to have a process to check
instances where eligible professionals
report on less than 3 measures to ensure
the that the minimum reporting
requirement of reporting at least 3
measures is, in fact, impracticable.
Based on the comments received and
for the reasons stated previously, we are
finalizing the 2012 criteria for
In addition, an eligible professional
who reports on fewer than three
measures through the claims-based
reporting mechanism may be subject to
the Measure Applicability Validation
(MAV) process, which will allow us to
determine whether an eligible
professional should have reported
quality data codes for additional
measures. Under the MAV process,
when an eligible professional reports on
fewer than 3 measures, we will perform
a review to determine whether there are
other closely related measures (such as
those that share a common diagnosis or
those that are representative of services
typically provided by a particular type
of eligible professional). If an eligible
professional who reports on fewer than
3 measures in 2012 reports on a measure
that is part of an identified cluster of
closely related measures and does not
report on any other measure that is part
of that identified cluster of closely
related measures, then the eligible
professional will not qualify as a
satisfactory reporter in the 2012
Physician Quality Reporting System or
earn an incentive payment.
emcdonald on DSK4SPTVN1PROD with RULES2
measures to undergo the MAV process,
particularly since the program has not
specifically identified which measures
may be applicable to eligible
professionals’ respective practices.
Response: We provided this process
as a way for eligible professionals to
participate in the Physician Quality
Reporting System when they may not
have 3 measures applicable to their
practice (which is the minimum number
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73331
requirement. The following is a
summary of the comments we received.
Comment: One commenter stated that
eligible professionals reporting via
registry should report on quality scores
on a sample drawn from all the eligible
professional’s patients.
Response: We appreciate the
commenter’s feedback. However, as we
may collect information on Medicare
Part B FFS patients via claims, we are
only requiring that eligible professionals
who report on Physician Quality
Reporting System quality measure via
registry report on their Medicare Part B
FFS patients.
Based on the comments received and
for the reasons stated previously, we are
finalizing the 2012 criteria for
satisfactory reporting of data on
individual Physician Quality Reporting
System quality measures for individual
eligible professionals via registry
described in Table 41. However, for the
same operational reasons we discussed
previously regarding claims-based
reporting, we are not finalizing the
criteria for satisfactory reporting that we
proposed for eligible professionals
practicing in internal medicine, family
practice, general practice, and
cardiology. Therefore, Table 41 reflects
the criteria for satisfactory reporting of
data on Physician Quality Reporting
System quality measures via registry for
all eligible professionals.
(3) Criteria for Satisfactory Reporting
of Individual Quality Measures for
Individual Eligible Professionals via
EHR
Section 1848(m)(3)(A) of the Act
established the criteria for satisfactorily
submitting data on individual quality
measures as at least three measures in
at least 80 percent of the cases in which
the measure is applicable. For years
after 2009, section 1848(m)(3)(D) of the
Act authorizes the Secretary, in
consultation with stakeholders and
experts, to revise the criteria for
satisfactorily reporting data on quality
measures. Accordingly, we proposed the
following options for satisfactory
reporting of individual quality measures
by individual eligible professionals
participating in the 2012 Physician
Quality Reporting System via the EHRbased reporting mechanism:
First, we proposed (76 FR 42854) that
an eligible professional would meet the
criteria for satisfactory reporting under
the Physician Quality Reporting System
if the eligible professional, using a
Physician Quality Reporting System
‘‘qualified’’ EHR product (if the eligible
professional is also participating in the
EHR Incentive Program via the
Physician Quality Reporting SystemEHR Incentive Pilot discussed in section
VI.H. of this final rule with comment
period, the eligible professional’s EHR
product must also be Certified EHR
Technology), reports on three core
measures for 80 percent of the eligible
professional’s Medicare Part B FFS
patients seen during the reporting
period to which each measure applies as
identified in Table 28 of the proposed
rule (76 FR 42863), which are identical
to the Medicare EHR Incentive Program
core measures included in Table 7 of the
Medicare and Medicaid EHR Incentive
Program final rule (75 FR 44410). For all
core measures identified in Table 28 of
the proposed rule except for the
measures titled ‘‘Preventive Care and
Screening: Body Mass Index (BMI)
Screening and Follow-up’’ and
‘‘Measure pair: a. Tobacco Use
Assessment, b. Tobacco Cessation
Intervention’’, insofar as the
denominator for one or more of the core
measures is 0, implying that the eligible
professional’s patient population is not
addressed by these measures, we
proposed (76 FR 42854) that eligible
professionals would be required to
report up to three alternate core
measures as identified in Table 28 of the
proposed rule and which are identical
to the Medicare EHR Incentive Program
alternate core measures included in
Table 7 of the Medicare and Medicaid
EHR Incentive Program final rule, (75
FR 44410). In addition, we proposed
that the eligible professional would be
required to report on three additional
measures of their choosing that are
available for the Medicare EHR
Incentive Program in Table 6 of the
Medicare and Medicaid EHR Incentive
Program final rule (75 FR 44398 through
44408) (as identified in 29 of the
proposed rule).
Section 1848(m)(7) of the Act
(‘‘Integration of Physician Quality
Reporting and EHR Reporting’’), as
added by section 3002(d) of the
Affordable Care Act, requires us to move
towards the integration of EHR
measures with respect to the Physician
Quality Reporting System. Section
1848(m)(7) of the Act specifies that by
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emcdonald on DSK4SPTVN1PROD with RULES2
of receiving an incentive payment for
reporting.
We invited public comment on the
proposed criteria for satisfactory
reporting of individual quality measures
for individual eligible professionals via
registry. The following is a summary of
the comments we received. We also
sought public comment as to whether
geriatricians should be included as a
specialty required to report all 2012
Physician Quality Reporting System
core measures. In addition, we sought
public comment on whether other
specialties should be included in the
2012 Physician Quality Reporting
System core measure reporting
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emcdonald on DSK4SPTVN1PROD with RULES2
no later than January 1, 2012, the
Secretary shall develop a plan to
integrate reporting on quality measures
under the Physician Quality Reporting
System with reporting requirements
under subsection (o) of section 1848 of
the Act relating to the meaningful use of
EHRs. Such integration shall consist of
the following:
(A) The selection of measures, the
reporting of which both would
demonstrate—
(i) Meaningful use of an EHR for
purposes of the Medicare EHR Incentive
Program; and
(ii) Quality of care furnished to an
individual; and
(B) Such other activities as specified
by the Secretary.
We proposed the aforementioned
criteria for satisfactory reporting via an
EHR, which is identical to the criteria
for achieving meaningful use for
reporting clinical quality measures
under the EHR Incentive Program as
finalized in the Medicare and Medicaid
Electronic Health Record Incentive
Program final rule (75 FR 44409 through
44411), in an effort to align the
Physician Quality Reporting System
with the Medicare EHR Incentive
Program.
In addition to the reporting criteria
proposed (76 FR 42854) previously, we
proposed alternative reporting criteria
for satisfactory reporting using the EHRbased reporting mechanism that is
similar to the criteria finalized in the CY
2011 MPFS Final Rule with comment
period (75 FR 73497 through 73500).
For the reasons set forth for establishing
different criteria for satisfactory
reporting via claims and registry, we
proposed to adopt two different criteria
for satisfactory reporting, depending on
an eligible professional’s specialty. For
eligible professionals specializing in
internal medicine, family practice,
general practice, and cardiology, we
proposed the following criteria:
• Report on ALL Physician Quality
Reporting System core measure as
identified in Table 28 of the proposed
rule (76 FR 42863) AND
• Report each measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients for whom
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services were furnished during the
reporting period to which the measure
applies.
We understood that by requiring
eligible professionals specializing in
internal medicine, family practice,
general practice, and cardiology to
report all Physician Quality Reporting
System core measures, we would be
requiring such professionals to report
more measures than eligible
professionals who do not practice
within those specialties. We believe,
however, that requiring these specialists
to report on all Physician Quality
Reporting System core measures would
not add an additional burden to these
eligible professionals because the
reporting of measures is done entirely
through the EHR. Furthermore, because
we are proposing to require these
specialties to report on all Physician
Quality Reporting System core measures
and recognize that some of the
Physician Quality Reporting System
core measures may not be applicable to
all of these eligible professionals’
specialties, we proposed to allow the
reporting of these Physician Quality
Reporting System core measures with a
zero percent performance rate. That is,
the reporting of a Physician Quality
Reporting System core measure that is
not applicable to the eligible
professional’s practice in this instance
will not preclude an eligible
professional from meeting the criteria
for satisfactory reporting.
For the reasons we stated previously
for creating separate reporting criteria
for all other eligible professionals for
claims and registry reporting, we
proposed (76 FR 42854) the following
criteria for satisfactory reporting using
the EHR-based reporting mechanism—
• Report on at least three Physician
Quality Reporting System EHR
measures of the eligible professional’s
choosing; AND
• Report each measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients for whom
services were furnished during the
reporting period to which the measure
applies.
We invited public comment on the
proposed criteria for satisfactory
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reporting of individual quality measures
by individual eligible professionals via
an EHR-based reporting mechanism in
the 2012 Physician Quality Reporting
System. We also sought public comment
as to whether geriatricians should be
included as a specialty required to
report all 2012 Physician Quality
Reporting System core measures. In
addition, we sought public comment on
whether other specialties should be
included in the 2012 Physician Quality
Reporting System core measure
reporting requirement. In addition to the
comments summarized and addressed
previously regarding our proposal to
require certain specialties to report on
core measures, the following is a
summary of the remaining comments
we received regarding these proposals.
Comment: Several commenters
supported the proposed criteria for
EHR-based reporting for the 2012
Physician Quality Reporting System that
aligns with the EHR Incentive Program.
In general, the commenters supported
our efforts to align the Physician Quality
Reporting System and EHR Incentive
Program.
Response: Aligning the Physician
Quality Reporting System and EHR
Incentive Program is a top priority, as
we seek to minimize the reporting
burden that the various CMS quality
reporting programs may pose on eligible
professionals who choose to participate
in more than one program.
After considering the comments and
for the reasons we stated previously, we
are only finalizing the criteria for
satisfactory reporting via EHR for the
2012 Physician Quality Reporting
System described in Table 42. For the
operational reasons discussed
previously, we are not finalizing the
criteria for satisfactory reporting via
EHR that we proposed for eligible
professionals practicing in internal
medicine, family practice, general
practice, and cardiology. Therefore,
Table 42 reflects the criteria for
satisfactory reporting of data on
Physician Quality Reporting System
quality measures via EHR for all eligible
professionals.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
(4) Criteria for Satisfactory Reporting of
Measures Groups via Claims—
Individual Eligible Professionals
Under § 414.90(b), ‘‘measures group’’
is defined as ‘‘a subset of four or more
Physician Quality Reporting System
measures that have a particular clinical
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condition or focus in common.’’ For
2012 and beyond, we proposed that
individual eligible professionals have
the option to report measures groups in
addition to individual quality measures
to qualify for the Physician Quality
Reporting System incentive, using
claims or registries.
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73333
For the reasons we proposed (76 FR
42855) different criteria for satisfactorily
reporting individual quality measures
depending on specialty, specifically our
desire to introduce core measures
applicable to certain specialties and
promote cardiovascular care, we
proposed two different criteria for
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satisfactorily reporting measures groups.
We proposed the following criteria for
satisfactory reporting of 2012 Physician
Quality Reporting System measures
groups:
We proposed that eligible
professionals specializing in internal
medicine, family practice, general
practice, and cardiology may meet the
criteria for satisfactory reporting of
Physician Quality Reporting System
measures groups via claims by reporting
in the following manner:
• Report at least one Physician
Quality Reporting System measures
group; AND
• If the measures group does not
contain at least one Physician Quality
Reporting System core measure, then
one Physician Quality Reporting System
core measure; AND
• For each measures group and, if
applicable, Physician Quality Reporting
System core measure reported, report on
at least 30 Medicare Part B FFS patients
for each measures group that is
reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
We also proposed that eligible
professionals specializing in internal
medicine, family practice, general
practice, and cardiology may meet the
criteria for satisfactorily reporting
Physician Quality Reporting System
measures groups via claims by reporting
in the following manner:
• Report at least one Physician
Quality Reporting System measures
group; BUT
• If the measures group does not
contain at least one Physician Quality
Reporting System core measure, then
one Physician Quality core measure.
• For each measures group and, if
applicable, Physician Quality Reporting
System core measure reported, report on
at least 50 percent of the eligible
professional’s Medicare Part B FFS
patients seen during the reporting
period to whom the measures group
applies; but report no less than 15
Medicare Part B PFS patients for each
measures group reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
For all other eligible professionals, in
order to meet the criteria for satisfactory
reporting of Physician Quality Reporting
measures groups via claims, we
proposed that the eligible professional
must:
• Report at least one Physician
Quality Reporting System measures
group; AND
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• Report on at least 30 Medicare Part
B FFS patients for each measures group
that is reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
Alternatively, eligible professionals
not specializing in internal medicine,
family practice, general practice, and
cardiology may meet the criteria for
satisfactorily reporting Physician
Quality Reporting System measures
groups via claims by reporting in the
following manner:
• Report at least one Physician
Quality Reporting System measures
group; AND
• For each measures group reported,
report each on at least 50 percent of the
eligible professional’s Medicare Part B
FFS patients seen during the reporting
period to whom the measures group
applies; BUT
• Report no less than 15 Medicare
Part B PFS patients for each measures
group reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
Aside from the Physician Quality
Reporting System core measure
reporting requirement for eligible
professionals specializing in internal
medicine, family practice, general
practice, or cardiology, we proposed to
retain the same criteria for satisfactory
reporting of measures groups via claims
as the 2011 criteria for satisfactory
reporting of measures groups via claims
for the 12-month reporting period that
was finalized in the 2011 MPFS Final
Rule with comment period, because we
believe consistent reporting criteria will
in turn lead to a greater chance that
eligible professionals meet the criteria
for satisfactory reporting (76 FR 42854).
Therefore, as in 2011, we proposed that
an eligible professional must
satisfactorily report on all individual
measures within the measures group in
order to meet the criteria for satisfactory
reporting via measures groups.
For 2012, in order to ensure that the
Physician Quality Reporting System
measures on which eligible
professionals report are applicable to
their respective practices, we proposed
(76 FR 42854) not to count measures
within measures groups that are
reported through claims or registry that
have a zero percent performance rate.
That is, if the recommended clinical
quality action is not performed on at
least one patient for a particular
measure reported by the eligible
professional via claims or registry, we
will not count the measures group as a
measures group reported by an eligible
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professional. Furthermore, this
proposed requirement is consistent with
the reporting options for individual
quality measures, which are discussed
previously. Since we proposed to retain
the requirement that an eligible
professional must satisfactorily report
on all individual measures contained
within a measures group in order to
meet the criteria for satisfactory
reporting via measures groups, if an
eligible professional reports a measure
contained within a measures group with
a zero percent performance rate, the
eligible professional will fail to meet the
criteria for the satisfactory reporting of
measures groups.
We invited public comment on the
2012 criteria for satisfactory reporting
on measures groups via claims for
individual eligible professionals. We
also sought public comment as to
whether geriatricians should be
included as a specialty required to
report at least 1 proposed 2012
Physician Quality Reporting System
core measure for measures group
reporting. In addition, we sought public
comment on whether other specialties
should be included in the 2012
Physician Quality Reporting System
core measure reporting requirement for
measures groups. The following is a
summary of the comments we received.
Comment: One commenter was
opposed to the proposed criterion that
measures with a zero percent
performance rate will not be counted.
Response: We appreciate the
commenter’s feedback. However, as we
stated previously, we are interested in
moving away from pro forma reporting.
We are interested in concentrating on
the collection of meaningful data.
Therefore, for the reasons we stated
previously, we are finalizing our
proposal to only count measures
reported via claims, registry, and EHR
with a zero percent performance rate.
Based on the comments received and
for the reasons stated previously, we are
finalizing the 2012 criteria for
satisfactory reporting of measures
groups via claims for individual eligible
professionals described in Table 43. For
the operational reasons discussed
previously, however, we are not
finalizing our proposals for eligible
professionals practicing in internal
medicine, family practice, general
practice, and cardiology. Therefore,
Table 43 reflects the final criteria for
satisfactory reporting of data on
Physician Quality Reporting System
quality measures groups via claims for
all eligible professionals.
E:\FR\FM\28NOR2.SGM
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An eligible professional could also
potentially qualify for the Physician
Quality Reporting System incentive
payment by satisfactorily reporting both
individual measures and measures
groups. However, only one incentive
payment will be made to the eligible
professional.
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(5) 2012 Criteria for Satisfactory
Reporting of Measures Groups via
Registry—Individual Eligible
Professionals
As with the reporting of measures
groups via claims, we proposed (76 FR
42857) different criteria for the
satisfactory reporting of Physician
Quality Reporting System measures
groups via registry depending on the
eligible professional’s specialty. For
eligible professionals specializing in
internal medicine, family practice,
general practice, or cardiology, in order
to meet the criteria for the satisfactory
reporting of Physician Quality Reporting
measures groups via registry, during the
12-month reporting period, we proposed
that the eligible professional must—
• Report at least 1 Physician Quality
Reporting System measures group; AND
• If the measures group does not
contain at least 1 Physician Quality
Reporting System core measure, then 1
Physician Quality Reporting System
core measure; AND
• Report on at least 30 Medicare Part
B FFS patients for each measures group
and, if applicable, Physician Quality
Reporting System core measure
reported.
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• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
Alternatively, we proposed that the
eligible professional specializing in
internal medicine, family practice,
general practice, or cardiology may meet
the criteria for the satisfactory reporting
of Physician Quality measures groups
via registry by doing the following
during the 12-month reporting period:
• Report at least one Physician
Quality Reporting System measures
group; AND
• If the measures group does not
contain at least 1 Physician Quality
Reporting System core measure, then 1
Physician Quality Reporting System
core measure; AND
• Report each measures group and, if
applicable, Physician Quality Reporting
System core measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to whom the
measures group applies; BUT
• Report each measures group on no
less than 15 Medicare Part B FFS
patients seen during the reporting
period to which the measures group
applies.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
In order to meet the criteria for the
satisfactory reporting of Physician
Quality Reporting measures groups via
registry, during the 6-month reporting
period, we proposed that the eligible
professional must—
• Report at least one Physician
Quality Reporting System measures
group; AND
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73335
• If the measures group does not
contain at least 1 Physician Quality core
measure, then 1 Physician Quality core
measure; AND
• Report each measures group and, if
applicable, Physician Quality Reporting
System core measure for at least 80
percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to whom the
measures group applies; BUT
• Report each measures group on no
less than 8 Medicare Part B FFS patients
seen during the reporting period to
which the measures group applies.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
For all other eligible professionals, in
order to meet the criteria for the
satisfactory reporting of Physician
Quality Reporting System measures
groups via registry, we proposed that,
during the 12-month reporting period,
the eligible professional must—
• Report at least 1 Physician Quality
Reporting System measures group; AND
• Report each measures group for at
least 30 Medicare Part B FFS patients.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
Alternatively, we proposed that an
eligible professional not specializing in
internal medicine, family practice,
general practice, or cardiology may meet
the criteria for the satisfactory reporting
of Physician Quality Reporting System
measures groups via registry by doing
the following during the 12-month
reporting period:
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• Report at least one Physician
Quality Reporting System measures
group; AND
• For each measures group reported,
report on at least 80 percent of the
eligible professional’s Medicare Part B
FFS patients seen during the reporting
period to whom the measures group
applies; BUT
• Report no less than 15 patients for
each measures group reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
For all other eligible professionals, in
order to meet the criteria for the
satisfactory reporting of Physician
Quality Reporting System measures
groups via registry during the 6-month
reporting period, we proposed that,
during the proposed 6-month reporting
period, the eligible professional must—
• Report at least 1 Physician Quality
Reporting System measures group; AND
• For each measures group reported,
report on at least 80 percent of the
eligible professional’s Medicare Part B
FFS patients seen during the reporting
period to whom the measures group
applies; BUT
• Report each measures group on no
less than least 8 Medicare Part B FFS
patients for each measures group
reported.
• Measures groups containing a
measure with a zero percent
performance rate will not be counted.
Aside from the Physician Quality
Reporting System core measure
reporting requirement for eligible
professionals specializing in internal
medicine, family practice, general
practice, or cardiology, we proposed to
retain the same criteria for satisfactory
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reporting of measures groups via
registry as the 2011 criteria for
satisfactory reporting of measures
groups via registry finalized in the 2011
MPFS Final Rule with comment period.
Therefore, as in 2011, an eligible
professional must satisfactorily report
on all individual measures within the
measures group in order to meet the
criteria for satisfactory reporting via
measures groups. We proposed to retain
the same criteria, because, since eligible
professionals are already familiar with
this reporting criteria, we believe having
consistent reporting criteria will in turn
lead to a greater chance that eligible
professionals meet the criteria for
satisfactory reporting.
For 2012, in order to ensure that the
Physician Quality Reporting System
measures on which eligible
professionals report are applicable to
their respective practices, we proposed
not to count measures within measures
groups that are reported through claims
or registry that have a zero percent
performance rate. That is, if the
recommended clinical quality action is
not performed on at least one patient for
a particular measure reported by the
eligible professional via claims or
registry, we will not count the measures
groups as a measures group reported by
an eligible professional. Furthermore,
this requirement is consistent with the
reporting options for individual quality
measures, which were discussed
previously. Since we proposed to retain
the requirement that an eligible
professional must satisfactorily report
on all individual measures contained
within a measures group in order to
meet the criteria for satisfactory
reporting via measures groups, if an
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eligible professional reports a measure
contained within a measures group with
a zero percent performance rate, the
eligible professional will fail to meet the
criteria for the satisfactory reporting of
measures groups.
We also sought public comment as to
whether geriatricians should be
included as a specialty required to
report at least 1 proposed 2012
Physician Quality Reporting System
core measure for measures group
reporting. In addition, we sought public
comment on whether other specialties
should be included in the 2012
Physician Quality Reporting System
core measure reporting requirement for
measures groups. The summary of these
comments and our responses was
discussed previously in this final rule
with comment period.
We invited but received no public
comment on the proposed 2012 criteria
for satisfactory reporting on measures
groups via registry for individual
eligible professionals. Therefore, for the
reasons stated previously, we are
finalizing the 2012 criteria for
satisfactory reporting of data on
measures groups via registry described
in Table 44. However, for the
operational reasons discussed
previously, we are not finalizing our
proposals regarding eligible
professionals practicing in internal
medicine, family practice, general
practice, and cardiology. Therefore,
Table 42 reflects the final criteria for
satisfactory reporting of data on
Physician Quality Reporting System
quality measures via EHR for all eligible
professionals.
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An eligible professional could also
potentially qualify for the Physician
Quality Reporting System incentive
payment by satisfactorily reporting both
individual measures and measures
groups. However, only one incentive
payment will be made to the eligible
professional.
(6) 2012 Criteria for Satisfactory
Reporting on Physician Quality
Reporting System Measures by Group
Practices Under the Group Practice
Reporting Option (GPRO)
Instead of participating as an
individual eligible professional, an
eligible professional in a group practice
may participate in the Physician Quality
Reporting System under the Physician
Quality Reporting System GPRO.
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However, an individual eligible
professional who is affiliated with a
group practice participating in the
Physician Quality Reporting System
GPRO that satisfactorily submits
Physician Quality Reporting System
quality measures will only be able to
earn an incentive as part of the group
practice and not as an individual
eligible professional.
We proposed (76 FR 42859) that
group practices interested in
participating in GPRO must selfnominate. As stated in section
VI.F.1.e.6. of this final rule with
comment period, for group practices
selected to participate in the Physician
Quality Reporting System GPRO for
2012, we finalized a 12-month reporting
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period beginning January 1, 2012. For
2012, we proposed (76 FR 32859) to use
the same GPRO reporting methods that
we have used in prior years.
Specifically, we proposed that group
practices participating in GPRO submit
information on measures within a
common set of 30 NQF-endorsed quality
measures using a web interface based on
the GPRO web interface used in the
2011 Physician Quality Reporting
System GPRO. As part of the data
submission process for 2012 GPRO, we
proposed that during 2012, each group
practice would be required to report
quality measures with respect to
services furnished during the 2012
reporting period (that is, January 1,
2012, through December 31, 2012) on an
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assigned sample of Medicare
beneficiaries. Once the beneficiary
assignment has been made for each
group practice, which we anticipated
would be done during the fourth quarter
of 2012, we proposed to provide each
group practice selected to participate in
the Physician Quality Reporting System
GPRO with access to a web interface
that would include the group’s assigned
beneficiary samples and the final GPRO
quality measures. We proposed to prepopulate the web interface with the
assigned beneficiaries’ demographic and
utilization information based on all of
their Medicare claims data. The group
practice would be required to populate
the remaining data fields necessary for
capturing quality measure information
on each of the assigned beneficiaries.
In 2011, to distinguish the criteria in
GPRO I and II for satisfactory reporting
between small vs. large groups, we
established different reporting criteria
dependent on the group’s size. Although
we are consolidating the GPRO for 2012,
we still recognize the need to equalize
the reporting burden by establishing
different reporting criteria for small vs.
large groups. Therefore, we proposed to
establish the following two criteria for
the satisfactory reporting of Physician
Quality Reporting System quality
measures under the 2012 GPRO, based
on the size of the group practice:
• For group practices comprised of
25–99 eligible professionals
participating in the GPRO, we proposed
that the group practice must report on
all GPRO measures included in the web
interface (listed in Table 55 of the
proposed rule (76 FR 42880)). During
the submission period, the group
practice will need to access the web
interface and populate the data fields
necessary for capturing quality measure
information on each of the assigned
beneficiaries up to 218 beneficiaries
(with an over-sample of 327
beneficiaries) for each disease module
and preventive care measure. We further
proposed that if the pool of eligible
assigned beneficiaries for any disease
module or preventive care measure is
less than 218, then the group practice
would need to populate the remaining
data files for 100 percent of eligible
assigned beneficiaries for that disease
module or preventive care measure. For
each disease module or preventive care
measure, we proposed that the group
practice must report information on the
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assigned patients in the order in which
they appear in the group’s sample (that
is, consecutively).
• For group practices comprised of
100 or more eligible professionals, we
proposed that the group practices must
report on all Physician Quality
Reporting System GPRO quality
measures. During the submission
period, the group practice would need
to populate the remaining data fields in
the web interface necessary for
capturing quality measure information
on each of the assigned beneficiaries up
to 411 beneficiaries (with an oversample of 616 beneficiaries) for each
disease module and preventive care
measure. We further proposed that if the
pool of eligible assigned beneficiaries
for any disease module or preventive
care measure is less than 411, then the
group practice must populate the
remaining data fields for 100 percent of
eligible assigned beneficiaries for that
disease module or preventive care
measure. For each disease module or
preventive care measure, we proposed
that the group practice must report
information on the assigned patients in
the order in which they appear in the
group’s sample (that is, consecutively).
In determining the appropriate reporting
criteria for group practices comprised of
100 or more eligible professionals, we
sought to use the same criteria we
finalized in the 2011 MPFS Final Rule
with comment period for GPRO I (75 FR
73506) because group practices are
already familiar with this reporting
process. We hope that establishing the
same process for reporting under the
GPRO as used in prior years will
provide a likelier chance for meeting the
criteria for satisfactory reporting under
the GPRO. In addition, we sought to
align the criteria for satisfactory
reporting under the Physician Quality
Reporting System with CMS’ PGP
demonstration, which collects data from
large group practices in an effort to
coordinate the overall care delivered to
Medicare patients.
As we discussed previously with our
definition of group practice, we allow
for fluctuation of the group practice’s
size throughout the reporting period,
provided that the group size contains at
least 25 eligible professionals, which is
the minimum group practice size for
participation in the Physician Quality
Reporting System GPRO. However, as
we established in 2011, for purposes of
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determining which reporting criteria the
group must satisfy, a group practice’s
size will be the size of the group at the
time the group’s participation is
approved by CMS (75 FR 73504). For
example, if a group practice is
comprised of 100 eligible professionals
at the time it self-nominates for
participation as a GPRO in 2012, and
the group practice’s size then drops to
99 eligible professionals at the time the
group practice’s participation is
approved by CMS, the group practice
would need to meet the reporting
criteria for a group size of 99.
We invited public comment on the
proposed requirements for satisfactory
reporting via the Physician Quality
Reporting System GPRO reporting
option. The following is a summary of
the comments we received that were
related to the proposed 2012 criteria for
satisfactory reporting for group practices
in the Physician Quality Reporting
System GPRO.
Comment: Some commenters urged us
to modify the GPRO web interface to
minimize burden of use of the web
interface, particularly by minimizing the
manual processes required to populate
the remaining fields.
Response: The patient data can be
extracted from an EHR and uploaded
into the web interface, which eliminates
the need for manual abstraction. CMS
will continue development efforts to
enhance tool so that there is decreased
burden on group practices reporting via
the web interface.
After considering the comments and
for the reasons stated previously, we are
finalizing all of the proposed 2012
criteria for satisfactory reporting for
group practices participating in the
Physician Quality GPRO. Table 45
summarizes the criteria for the
satisfactory reporting of data on quality
measures by group practice under the
2012 Physician Quality Reporting
GPRO. Group practices participating in
the 2012 Physician Quality Reporting
System GPRO, regardless of size, are
required to report on all of the measures
listed in Table 71 of this final rule with
comment period. These quality
measures are grouped into preventive
care measures and five disease modules:
heart failure, diabetes, coronary artery
disease, hypertension, and chronic
obstructive pulmonary disease (COPD).
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Furthermore, although we are
requiring that the group practices
participating in the GPRO to report on
a certain number of consecutive
patients, such as either 218 or 411
beneficiaries depending on the group’s
size, we will allow the ‘‘skipping’’ of
patients for valid reasons, such as a
beneficiary’s medical records not being
found or not being able to confirm a
diagnosis. However, excessive skipping
of patients may cause us to question the
accuracy or validity of the data being
reported to us by the group practices.
Due to the variance in group patterns,
measures, and disease modules,
however, it is difficult to establish a
‘‘skip threshold’’ for the satisfactory
reporting of GPRO measures. Therefore,
it is our intent to examine each group
practice’s skip patterns. We may request
the group to provide additional
information to help explain or support
the skips to help better inform us on
what levels of skipping could
potentially be considered excessive
skipping in a future year.
We intend to post the final 2012
Physician Quality Reporting System
GPRO participation requirements for
group practices, including instructions
for submitting the self-nomination
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statement and other requested
information, on the Physician Quality
Reporting System section of the CMS
Web site at https://www.cms.gov/PQRS
by November 15, 2011 or shortly
thereafter.
The Physician Quality Reporting
System GPRO web interface will be
updated as needed to include the 2012
Physician Quality Reporting System
GPRO measures (that is, to eliminate
measures that have been retired as well
as add additional measures that will be
finalized for 2012). We intend to
provide the selected physician groups
with access to this pre-populated
database by no later than the first
quarter of 2012. For purposes of prepopulating this GPRO web interface, we
will assign beneficiaries to each group
practice using a patient assignment
methodology modeled after the patient
assignment methodology used in the
PGP & MCMP demonstrations. We will
use Medicare Part B claims data for
dates of service on or after January 1,
2011, and submitted and processed by
approximately October 31, 2011, to
assign Medicare beneficiaries to each
group practice. Assigned beneficiaries
will be limited to those Medicare Part B
FFS beneficiaries with Medicare Parts A
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and B claims for whom Medicare is the
primary payer. Assigned beneficiaries
will not include Medicare Advantage
enrollees. A beneficiary will be assigned
to the group practice that provides the
plurality of a beneficiary’s office or
other outpatient office evaluation and
management allowed charges.
Beneficiaries with only one office visit
to the group practice will be eliminated
from the group practice’s assigned
patient sample for purposes of the 2012
Physician Quality Reporting System
GPRO. We will pre-populate the GPRO
web interface with the assigned
beneficiaries’ demographic and
utilization information based on their
Medicare claims data.
f. 2012 Physician Quality Reporting
System Measures
(1) Statutory Requirements for the
Selection of the Final 2012 Physician
Quality Reporting System Measures
Under section 1848(k)(2)(C)(i) of the
Act, the Physician Quality Reporting
System 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 subsection 1890(a) of
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the Act (currently, that is the National
Quality Forum, or 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 AQA alliance. In light of
these statutory requirements, we believe
that, except in the circumstances
specified in the statute, each 2012
Physician Quality Reporting System
quality measure must be endorsed by
the NQF. Additionally, section
1848(k)(2)(D) of the Act requires that for
each 2012 Physician Quality Reporting
System 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)
(that is, the NQF) and are silent with
respect to how the measures that are
submitted to the NQF for endorsement
were 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
needs to be any 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 Physician Quality
Reporting System.
The following is a summary of
comments we received.
Comment: Several commenters
suggested that we only include NQFendorsed measures for reporting for the
2012 Physician Quality Reporting
System. Some of these commenters
strongly urged that all new measures
finalized for inclusion in the 2012
Physician Quality Reporting System be
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submitted to the NQF for endorsement.
Other commenters stated that, should
we include quality measures for
reporting under the 2012 Physician
Quality Reporting System that are not
NQF-endorsed, we ensure that these
quality measures undergo a review
process similar to NQF’s endorsement
procedures.
Response: We agree that endorsement
of measures by the NQF is an important
criterion for inclusion in the 2012
Physician Quality Reporting System.
However, section 1848(k)(2)(C)(ii) of the
Act provides an exception to the
requirement that measures be endorsed
by the NQF. We may exercise this
exception authority in a specified area
or medical topic for which a feasible
and practical measure has not been
endorsed by the NQF, so long as due
consideration is given to measures that
have been endorsed by the NQF. For
this reason, we retain the ability to
include non-NQF endorsed measures in
the Physician Quality Reporting System.
We encourage the measure owners to
submit all non-NQF measures that are
included in the 2012 Physician Quality
Reporting System for endorsement by
the NQF, if the measures have not
already been submitted for
endorsement. In future years, we may
consider removing a measure from the
program if the measure owner has
opportunities to submit the measure to
the NQF for review but does not do so.
(2) Other Considerations for the
Selection of 2012 Physician Quality
Reporting System Measures
In addition to reviewing the 2011
Physician Quality Reporting System
measures for purposes of developing the
2012 Physician Quality Reporting
System measures, we reviewed and
considered measure suggestions for the
2012 Physician Quality Reporting
System.
With respect to the selection of new
measures, we applied the following
considerations, which include many of
the same considerations applied to the
selection of 2009, 2010 and 2011
Physician Quality Reporting System
quality measures proposed (76 FR
42864) for inclusion in the 2012
Physician Quality Reporting System
quality measure set previously
described:
• High Impact on Healthcare.
++ Measures that are high impact and
support CMS and HHS priorities for
improved quality and efficiency of care
for Medicare beneficiaries. These
current and long term priority topics
include the following: prevention;
chronic conditions; high cost and high
volume conditions; elimination of
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health disparities; healthcare-associated
infections and other conditions;
improved care coordination; improved
outcomes; improved efficiency;
improved patient and family experience
of care; effective management of acute
and chronic episodes of care; reduced
unwarranted geographic variation in
quality and efficiency; and adoption and
use of interoperable HIT.
++ Measures that are included in, or
facilitate alignment with, other
Medicare, Medicaid, and CHIP programs
in furtherance of overarching healthcare
goals.
++ NQF Endorsement.
++ Measures must be NQF-endorsed
by August 15, 2011, in order to be
considered for inclusion in the 2012
Physician Quality Reporting System
quality measure set except, as provided
under section 1848(k)(2)(C)(ii) of the
Act.
++ 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).
• Address Gaps in the Physician
Quality Reporting System Measure Set.
++ Measures that increase the scope
of applicability of the Physician Quality
Reporting System measures to services
furnished to Medicare beneficiaries and
expand opportunities for eligible
professionals to participate in the
Physician Quality Reporting System.
• Measures of various aspects of
clinical quality including outcome
measures, where appropriate and
feasible, process measures, structural
measures, efficiency measures, and
measures of patient experience of care.
Other considerations that we applied
to the selection of proposed measures
for 2012, regardless of whether the
measure was a 2011 Physician Quality
Reporting System measure or not,
were—
• Measures that are functional, which
is to say measures that can be
technically implemented within the
capacity of the CMS infrastructure for
data collection, analysis, and
calculation of reporting and
performance rates;
• Measures that address gaps in the
quality of care delivered to Medicare
beneficiaries;
• Measures impacting chronic
conditions (chronic kidney disease,
diabetes mellitus, heart failure,
hypertension and musculoskeletal);
• Measures involving care
coordination;
• Measures applicable across care
settings (such as, outpatient, nursing
facilities, domiciliary, etc.);
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• Measures conducive to leveraging
capabilities of an electronic health
record (EHR);
• Measures whose detailed
specifications will be completed and
ready for implementation in the 2012
Physician Quality Reporting System;
• Broadly applicable measures that
could be used to create a core measure
set required of all participating eligible
professionals; and
• Measures groups that reflect the
services furnished to beneficiaries by a
particular specialty.
In the 2012 Physician Quality
Reporting System, as in the 2011
Physician Quality Reporting System, for
some measures that are useful, but
where data submission is not feasible
through all otherwise available
Physician Quality Reporting System
reporting mechanisms, we proposed
that a measure may be included for
reporting solely through specific
reporting mechanism(s) in which its
submission is feasible.
However, we stress that inclusion of
measures that are not NQF endorsed or
AQA adopted is an exception to the
requirement under section
1848(k)(2)(C)(i) of the Act that measures
be endorsed by the NQF. We may
exercise this exception authority in a
specified area or medical topic for
which a feasible and practical measure
has not been endorsed by NQF, so long
as due consideration is given to
measures that have been endorsed by
the NQF.
We invited comments on our
proposed approach in selecting
measures. The following is a summary
of the comments we received regarding
other considerations we have taken into
account with regard to selecting 2012
Physician Quality Reporting System
measures.
Comment: Several commenters
supported the inclusion of proposed
2012 Physician Quality Reporting
System measures that are either not
endorsed by NQF or pending NQFendorsement. However, some
commenters suggested that we properly
vet these non-NQF-endorsed measures
prior to including them for reporting
under the 2012 Physician Quality
Reporting System.
Response: For measures that we
finalize that are not currently NQFendorsed, we are exercising our
authority under section 1848(k)(2)(C)(i)
of the Act to, among other reasons,
address gaps in a specified area or
medical topic. We note that, prior to
rulemaking, we review these submitted
measures with the measure owners prior
to including these measures for
reporting under the 2012 Physician
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Quality Reporting System. Among other
factors, we examine the utility of each
quality measure that was submitted, the
feasibility of reporting the measure, as
well as our ability to analyze the data
provided by the reporting of the
measure.
Comment: One commenter stated that
the following measures should be
retired from reporting in the 2012
Physician Quality Reporting System,
because they have been retired by the
measure owner or are no longer
applicable for quality reporting
purposes:
• #135: Chronic Kidney Disease
(CKD): Influenza Immunization.
• #79: End Stage Renal Disease
(ESRD): Influenza immunization in
Patients with ESRD.
• #175: Pediatric Stage Renal Disease
(ESRD): Influenza Immunization.
The commenter stated that Physician
Quality Reporting System measure no.
110 titled ‘‘Preventive Care and
Screening: Influenza Immunization for
Patients ≥ 50 Years Old’’ has been
updated to incorporate the influenza
immunization measures. Therefore, the
commenter encouraged reporting of
Physician Quality Reporting System
measure no. 110 in lieu of these retired
measures. Another commenter also
supported retiring Physician Quality
Reporting System measure #79.
Response: We agree and are not
finalizing those measures for reporting
under the 2012 Physician Quality
Reporting System.
Comment: One commenter suggested
that we retire Physician Quality
Reporting System measure #199 titled
‘‘Heart Failure: Patient Education’’
because this measure is no longer
available for quality reporting.
Response: We agree and are not
finalizing this measure for reporting
under the 2012 Physician Quality
Reporting System.
Comment: One commenter suggested
that we implement a ‘‘test measure’’
process, whereby a measure would be
tested for validity, feasibility, and
reliability prior to being included for
reporting under the Physician Quality
Reporting System.
Response: Although we do not
currently employ such a ‘‘test measure’’
process, we note that we review all
quality measures submitted for
inclusion for reporting under the
Physician Quality Reporting System
prior to proposing these measures for
inclusion. We also note that we view
implementation of a measure in the
Physician Quality Reporting System as
a vehicle for testing measures.
Comment: One commenter stated that,
as the number of measures and available
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reporting options have grown
substantially since the implantation of
the Physician Quality Reporting System
in 2007, we should look at the long-term
value of the measures we finalize for
inclusion as 2012 Physician Quality
Reporting System measures.
Response: We appreciate and agree
with the commenter’s feedback. For
example, when selecting measures for
inclusion in the 2012 Physician Quality
Reporting System, we took into
consideration medical topics or areas
not addressed in the 2011 Physician
Quality Reporting System quality
measures set, as well as which measures
would encourage reporting by a broader
scope of eligible professionals.
Comment: Some commenters stated
that the process of submitting,
reviewing, proposing, and finalizing
measures for inclusion in the 2012
Physician Quality Reporting System is
too slow. One commenter urged us to
work with the NQF and measure
developers to make the measure
selection process more efficient.
Response: We understand that there is
a need for measures to be reviewed,
tested, and endorsed by the NQF in a
timely fashion. We are committed to
working with the NQF and measure
owners to ultimately meet this goal. We
welcome suggestions on how to improve
the process for selecting measures for
inclusion under the Physician Quality
Reporting System.
Comment: One commenter suggested
that we collaborate more with medical
specialty boards when developing
measures.
Response: We note that we typically
do not develop measures. Rather, we
solicit measures that have been
developed by other measure developers
for possible inclusion for reporting in
the Physician Quality Reporting System
through an annual Call for Measures.
The Call for Measures for the 2013
program year has passed. However,
information about our annual Call for
Measures is typically posted on our Web
site at https://www.cms.gov/PQRS/
15_MeasuresCodes.asp#TopOfPage. We
encourage all medical specialty boards
to submit measure suggestions during
our future Call for Measures sessions.
Comment: Some commenters were
opposed to including quality measures
for reporting under the 2012 Physician
Quality Reporting System that were not
developed by physicians.
Response: We appreciate the
commenters’ feedback but respectfully
disagree. Although we welcome
measures developed by physicians, we
do not believe there needs to be any
restrictions on the type of professional
or organizations carrying out the basic
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development of measures for physicians
and other eligible professionals, such as
restricting the initial development to
physician-controlled organizations.
While we agree that expertise in
measure development is important in
the measure development and
consensus processes, 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. To
ensure that all measures may be
appropriately reported under the
Physician Quality Reporting System, we
review all measures prior to proposing
these measures for reporting. In
addition, we note that physicians are
not the only types of professionals
eligible to participate in the Physician
Quality Reporting System.
Comment: One commenter supported
the inclusion of NQF-endorsed
measures related to influenza,
pneumococcal, Hepatitis A, and
Hepatitis B vaccinations as we have
recognized the importance of collection
care information related to these
diseases.
Response: We appreciate the
commenter’s support and are finalizing
measures that are related to influenza,
pneumococcal disease, Hepatitis A, and
Hepatitis B vaccinations for the 2012
Physician Quality Reporting System. As
described in the following further detail,
measures involving these diseases are
available for reporting as individual
measures under the claims, registry, and
EHR-based reporting mechanism.
Comment: One commenter supported
the inclusion of Hepatitis C measures
available for reporting under the 2012
Physician Quality Reporting System.
However, the commenter notes that only
a subset of eligible professionals is able
to report on these measures.
Response: We appreciate the
commenter’s support of the finalized
Hepatitis C measures. We encourage the
commenter, as well as other
professional organizations and measure
developers, to submit additional
Hepatitis C measures that cover a
broader scope of eligible professionals
during the Physician Quality Reporting
System Call for Measures for future
program years.
Comment: Several commenters
suggested other considerations that we
should take into account when selecting
Physician Quality Reporting System
measures, such as—
• Focusing on including measures
that are related to the following medical
topics: anesthesia, hematology,
cardiology, abdominal aortic aneurysm
(AAA) screening, pelvic prolapsed,
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gynecologic cancer, chronic obstructive
pulmonary disease (COPD), elevated
blood pressure, and gastroenterology;
• Whether measures test an eligible
professional’s basic competencies,
rather than providing meaningful data
on patient care; and
• Whether measures focus on care
coordination.
Response: We appreciate the
commenters’ suggestions and will take
these other considerations into account
in future program years. We note that
we largely depend on the development
of measures by professional
organizations and other measure
developers and encourage professional
organizations and other measure
developers to fund and develop
measures that address the priority areas
identified by the commenters. In
addition, if there are specific measures
that commenters would like us to
consider for future years to address
these areas, measure suggestions may be
submitted during our annual Call for
Measures. Although the deadline to
submit new measures via this year’s Call
for Measures for suggesting possible
measures for the 2012 Physician Quality
Reporting System has passed, measure
suggestions may be submitted for
consideration for possible inclusion
under the 2014 Physician Quality
Reporting System and beyond.
We typically host a Call for Measures
each year and consider the measures
provided for the next program year.
However, we note that next year, we
will not host a Call for Measures for
measures to be included in the 2013
program year. This is due our need to
concentrate our efforts to convert
International Classification of Diseases
(ICD) codes (which classify all
diagnoses, symptoms, and procedures
recording in conjunction with care in
the United States) from ICD–9 to ICD–
10. This conversion affects quality
measures included in the Physician
Quality Reporting System, as these
measures currently contain ICD–9
codes. We believe that the transition
from ICD–9 to ICD–10 is necessary to
update care classifications. However, we
urge these commenters to submit these
specific measure suggestions for
consideration in a future Call for
Measures. Information on the Call for
Measures will be available on the
Physician Quality Reporting System
Web site at https://www.cms.gov/PQRS//
when it becomes available.
Comment: One commenter suggested
that we provide feedback in instances
where measures or measures groups that
were submitted for inclusion for
reporting for the 2012 Physician Quality
Reporting System were not ultimately
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proposed as 2012 Physician Quality
Reporting System quality measures or
measures groups.
Response: We agree and believe that
such feedback will be invaluable to
measure developers and owners with
regard to developing and suggesting
quality measures to be included in
future program years. We usually
provide this feedback to measure
developers for those individual
measures and measures groups that
were submitted for inclusion but
ultimately not proposed as 2012
Physician Quality Reporting System
individual measures or measures
groups.
Comment: Some commenters noted
that, at times, although CMS has
allowed for certain measures to be
reported under various CMS programs,
the description of some of these
measures (for example, measure titles)
may vary across the various CMS
programs. CMS suggested that we
synthesize the measure information we
provide, such as measure title and
number, with other various CMS
programs.
Response: We appreciate the
commenters’ feedback and agree with
the commenters. We understand that
consistent displays of information on
reportable measures across various CMS
programs will facilitate greater ease of
reporting for those eligible professionals
who participate in programs other than
the Physician Quality Reporting System.
However, we note that we are faced
with operational limitations that
prevent us from posting consistent
measure information, such as varied
rulemaking and measure review
timeframes. When possible, we provide
measure information that is consistent
with other CMS programs.
Comment: Several commenters asked
that the finalized 2012 Physician
Quality Reporting System individual
measures be grouped according to
medical specialty applicability.
Commenters believed that grouping
measures in this way would make it
easier for eligible professionals to
decide on which measures to report.
Commenters also noted the importance
of identifying clusters of measures prior
to potentially subjecting eligible
professionals to the Measure
Applicability Validation (MAV) process.
Response: We understand the
importance of providing guidance on
which measures to report. Although the
measures that we are finalizing in this
final rule with comment period are not
listed according to medical specialty,
we note that that we provide further
guidance on disease clusters in
subregulatory guidance on our Web site
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at https://www.cms.gov/PQRS//. For
example, the Physician Quality
Reporting System 2009 Reporting
Experience, which includes information
on some measures available for
reporting in 2012, provides information
on top measures on which certain
specialties have reported in past
program years. Information on the MAV
process is available in our ‘‘2011
Physician Quality Reporting System
Measure-Applicability Validation
Process’’ document available at https://
www.cms.gov/PQRS/25_AnalysisAnd
Payment.asp#TopOfPage. Eligible
professionals are also encouraged to
contact the QualityNet Help Desk for
guidance on satisfactory reporting.
Furthermore, eligible professionals who
are participating in the Physician
Quality Reporting System for the first
time may find it helpful to visit the
‘‘How to Get Started’’ section of our
Web site, available at https://
www.cms.gov/PQRS/03_How_To_Get_
Started.asp#TopOfPage, which provides
detailed information on all Physician
Quality Reporting System quality
measures available for reporting.
Comment: Several commenters
proposed new measures and measures
topics for inclusion in the 2012
Physician Quality Reporting System that
were not specifically proposed in the
proposed rule.
Response: We appreciate the
commenters’ suggestions on new
measures and measure topics. However,
as we stated in the proposed rule (76 FR
42862), section 1848(k)(2)(D) of the Act
requires that the public have the
opportunity to provide input during the
selection of measures. We also are
required to provide an opportunity for
public comment on provisions of policy
or regulation that are established via
notice and comment rulemaking.
Measures that are not included in this
final rule with comment period for
inclusion in the 2012 Physician Quality
Reporting System that are recommended
to us via comments on the proposed
rule have not been placed before the
public to comment on the selection of
those measures within the rulemaking
process. Even when measures have been
published in the Federal Register, but
in other contexts and not specifically
proposed as Physician Quality
Reporting System measures, we do not
believe that such publication provides
the best opportunity for public comment
on those measures’ potential inclusion
in the Physician Quality Reporting
System. Thus, such additional measures
recommended for selection for the 2012
Physician Quality Reporting System via
comments on the CY 2012 PFS
proposed rule are not included in the
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2012 measure set. As such, while we
welcomed all constructive comments
and suggestions, and may consider such
recommended measures for inclusion in
future measure sets for the Physician
Quality Reporting System and other
programs to which such measures may
be relevant, we are not able to consider
such additional measures for inclusion
in the final 2012 Physician Quality
Reporting System measure set.
In addition, as in prior years, we again
note that we do not use notice and
comment rulemaking as a means to
update or modify measure
specifications. Quality measures that
have completed the consensus process
have a designated party (usually, the
measure developer/owner) who has
accepted responsibility for maintaining
the measure. In general, it is the role of
the measure owner, developer, or
maintainer to make changes to a
measure. Therefore, comments
requesting changes to a specific
Physician Quality Reporting System
measure’s title, definition, and detailed
specifications or coding should be
directed to the measure developer
identified in Tables 52 through 55.
Contact information for the 2011
Physician Quality Reporting System
measure developers is listed in the
‘‘2011 Physician Quality Reporting
System Quality Measures List,’’ which
is available on the CMS Web site at
https://www.cms.gov/PQRS/
15_MeasuresCodes.asp#TopOfPage.
Based on the criteria previously
discussed, we proposed (76 FR 42862
and 42863) to include the individual
measures listed in Tables 29 through 31
in the 2012 Physician Quality Reporting
System individual quality measure set.
We believe that each measure we
proposed and are finalizing for reporting
under the 2012 Physician Quality
Reporting System meets at least one
criterion for the selection of Physician
Quality Reporting System measures
described previously. We are also
proposed (76 FR 42873) to include 24
measures groups in the 2012 Physician
Quality Reporting System quality
measure set, which were listed in Tables
32 through 55 of the proposed rule. The
proposed individual measures selected
for the 2012 Physician Quality
Reporting System were categorized as
follows—
• 2012 Physician Quality Reporting
System Core Measures Available for
Either Claims, Registry, and/or EHRbased Reporting;
• 2012 Physician Quality Reporting
System Individual Quality Measures
Available for Either Claims-based
Reporting and/or Registry-based
Reporting; and
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• 2012 Physician Quality Reporting
System Measures Available for EHRbased Reporting.
Please note that some individual
measures we proposed in Tables 32
through 55 of the proposed rule for
reporting for the 2012 Physician Quality
Reporting System may be available for
reporting in other CMS programs, such
as the Medicare and Medicaid EHR
Incentive Program as well as the
Medicare Shared Savings Program.
Please note that, in some instances, we
have made technical changes in
measure titles because the respective
measure owners have updated these
measure titles. We note that measure
titles, in some instances, may vary from
program to program. If an eligible
professional intends to report the same
measures for multiple CMS programs, it
is important to check the full measure
specifications, NQF measure number (if
applicable), as well as any other
identifying measure features to
determine whether the measures are the
same.
(3) 2012 Physician Quality Reporting
System Individual Measures
This section focuses on the 2012
Physician Quality Reporting System
Individual Measures available for
reporting via claims, registry, and/or
EHR-based reporting. For the proposed
2012 Physician Quality Reporting
System measures that were selected for
reporting in 2011, please note that
detailed measure specifications,
including the measure’s title, for the
2012 individual Physician Quality
Reporting System quality measures may
have been updated or modified during
the NQF endorsement process or for
other reasons prior to 2012. The 2012
Physician Quality Reporting System
quality measure specifications for any
given individual quality measure may,
therefore, be different from
specifications for the same quality
measure used in prior years.
Specifications for all 2012 individual
Physician Quality Reporting System
quality measures, whether or not
included in the 2011 Physician Quality
Reporting System program, must be
obtained from the specifications
document for 2012 individual Physician
Quality Reporting System quality
measures, which will be available on
the Physician Quality Reporting System
section of the CMS Web site on or before
December 31, 2011.
The following is a summary of general
comments received that were related to
the proposed 2012 Physician Quality
Reporting System individual quality
measures.
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Comment: Some commenters were
pleased to note that the proposed 2012
Physician Quality Reporting System
individual measures include ample
measures from which certain specialties
may report, such as vascular surgeons,
and audiologists.
Response: We appreciate the
commenter’s feedback and are pleased
that the 2012 Physician Quality
Reporting System provides many
measures on which these eligible
professionals can report.
Comment: Some commenters
suggested that measures that have been
updated or retired by the respective
measure owners be excluded from the
2012 Physician Quality Reporting
System.
Response: We update and retire
measures that have been either updated
or retired by the respective measure
owners.
Comment: Several commenters
suggested specific quality measures
and/or measure topics be included in
the 2012 Physician Quality Reporting
System that we did not propose in the
proposed rule, such as—
• NQF #492: Participation in a
practice-based or individual quality
database registry with a standard
measure set (NQF #492);
• NEQ #493: Participation by a
physician or other clinician in
systematic clinical database registry that
includes consensus endorsed quality
measures;
• Measures related to fluid
management; and
• Measures related to oncology.
Response: We appreciate the
commenters’ feedback. However, we are
obligated by section 1848(k)(2)(D) of the
Act to give eligible professionals an
opportunity to provide input on
measures recommended for selection,
which we do via the proposed rule.
Since the specific measures suggested
previously were not proposed for
inclusion, these additional measures
and/or measure topics cannot be
included for reporting under the 2012
Physician Quality Reporting System.
However, we will take these measure
suggestions into consideration for future
program years.
We describe the individual quality
measures we are finalizing for the 2012
Physician Quality Reporting System as
follows: (The measures specifications
for all finalized 2012 Physician Quality
Reporting System measures will be
available at https://www.cms.gov/PQRS/
15_MeasuresCodes.asp#TopOfPage.)
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(A) 2012 Physician Quality Reporting
System Core Measures Available for
Claims, Registry, and/or EHR-Based
Reporting
The prevention of cardiovascular
conditions is a top priority for CMS and
HHS. In fact, in 2011, HHS launched the
Million Hearts campaign, which is
aimed at preventing 1 million heart
attacks and strokes across the next 5years through clinical- and communitybased prevention strategies. Therefore,
in conjunction with the Million Hearts
campaign and in an effort to encourage
eligible professionals to monitor their
performance with respect to the
prevention of cardiovascular conditions,
we proposed (76 FR 42863) to adopt a
2012 Physician Quality Reporting
System set of core measures, identified
in Table 28 of the proposed rule, aimed
at promoting cardiovascular care.
We invited public comment on the
proposed 2012 Physician Quality
Reporting System core measures
available for claims, registry, and/or
EHR-based reporting. The following is a
summary of those comments.
Comment: Several commenters
supported the proposed set of 2012
Physician Quality Reporting System
core measures. While commenters
generally supported the development of
a set of Physician Quality Reporting
System core measures, some of these
commenters urge us to create additional
core measure sets related to other
disease modules (such as diabetes) for
future program years.
Response: We appreciate the
commenters’ feedback and are finalizing
all proposed 2012 Physician Quality
Reporting System core measures. We
will explore the development of
additional Physician Quality Reporting
System core measure sets for future
program years.
Comment: Some commenters opposed
the inclusion of the following two
measures as 2012 Physician Quality
Reporting System core measures,
because they are not NQF-endorsed—
• Preventive Care and Screening:
Blood Pressure Measurement; and
• Preventive Care: Cholesterol-LDL
test performed.
Response: We appreciate the
commenters’ feedback. However, as
stated previously, we believe these
measures address important gaps in the
Physician Quality Reporting System
quality measure set and are integral to
the Million Hearts campaign goal of
preventing heart attacks and strokes.
Comment: Several commenters
provided suggestions for other measures
that should be included as a 2012
Physician Quality Reporting System
core measure, such as—
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• Coronary Artery Disease (CAD):
Oral Antiplatelet Therapy Prescribed for
Patients with CAD
• Diabetes Mellitus: High Blood
Pressure Control in Diabetes Mellitus
• Coronary Artery Disease (CAD):
Lipid Control
Preventive Care and Screening: Body
Mass Index (BMI) Screening and
Follow-Up
• A lipid profile measure
Response: We appreciate the
commenters’ feedback. However, we did
not propose these measures for
inclusion in the 2012 Physician Quality
Reporting System as core measures. We
are obligated by section 1848(k)(2)(D) of
the Act to give eligible professionals an
opportunity to provide input on
measures recommended for selection,
which we do via the proposed rule.
Therefore, we are not finalizing these
additional measures that commenters
suggested for reporting under the 2012
Physician Quality Reporting System as
core measures. However, since these
measures are otherwise still generally
reportable under the Physician Quality
Reporting System via the claims,
registry, and/or EHR-based reporting
mechanisms, we encourage eligible
professionals to report on these
measures.
Comment: Some commenters
suggested we establish a Physician
Quality Reporting System core measure
set addressing other medical topics,
such as heart failure, ophthalmology,
gastroenterology, and coronary artery
disease.
Response: We appreciate the
commenters’ feedback and we are
interested in developing measure sets
that focus on other medical areas. We
will take these core measures
suggestions into consideration for future
program years.
Based on the comments received and
for the reasons stated previously, we are
finalizing the 2012 Physician Quality
Reporting System core measures listed
in the following Table 46. Please note
that the measure titled ‘‘Proportion of
adults 18-years and older who have had
their BP measured within the preceding
2-years’’ has been updated to
‘‘Preventive Care and Screening: Blood
Pressure Measurement.’’ Therefore, this
new measure title, when listed, will be
used in Tables 47 through 72.
As stated previously, we are not
requiring that eligible professionals
report on these core measures. However,
we view the reporting of these measures
as a top priority to report and strongly
encourage all eligible professionals to
report on these measures. We are also
listing these finalized Physician Quality
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(B) 2012 Physician Quality Reporting
System Individual Measures for Claims
and Registry Reporting
For 2012, we proposed (76 FR 42863)
to retain all measures currently used in
the 2011 Physician Quality Reporting
System. We believe these 2011
Physician Quality Reporting System
measures meet the statutory
considerations as well as other factors
we used in determining which measures
to include for reporting under the 2012
Physician Quality Reporting System.
The retention of these measures also
promotes program consistency. These
proposed measures included 55 registryonly measures currently used in the
2011 Physician Quality Reporting
System, and 144 individual quality
measures for either claims-based
reporting or registry-based reporting (75
FR 40186 through 40190, and 52489
through 52490). These proposed
measures do not include any measures
that were proposed to be included as
part of the following measures groups:
Back Pain, COPD, IBD, Sleep Apnea,
Epilepsy, Dementia, Parkinson’s,
Elevated Blood Pressure, and Cataracts.
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As we stated in the proposed rule (76
FR 42864), in 2011, Physician Quality
Reporting System measure #197 was
titled ‘‘Coronary Artery Disease (CAD):
Drug Therapy for Lowering LDL–
Cholesterol.’’ For 2012, we are changing
the title of measure #197 to ‘‘Coronary
Artery Disease: Lipid Control’’, because
the measure owner, AMA–PCPI, has
changed the title of the measure. Aside
from the title change, measure #197’s
NQF number as well as its NQFendorsement status has not changed.
However, as noted previously, eligible
professionals should check the measure
specifications for measure #197, as the
specifications on how to report on
measure #197 for the 2012 Physician
Quality Reporting System may change
from 2011.
In addition, we proposed (76 FR
42864) the 26 new individual measures
for inclusion in the 2012 Physician
Quality Reporting System in order to
provide eligible professionals with more
Physician Quality Reporting System
quality measures on which they can
select from to report. The following 2
proposed measures are NQF-endorsed:
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• Anticoagulation for Acute
Pulmonary Embolus Patients.
• Pregnancy Test for Female
Abdominal Pain Patients.
The remaining 24 measures we
proposed (76 FR 42864) were either
pending NQF endorsement or would
have to be adopted under the exception
to NQF endorsement provided under
section 1848(k)(2)(C)(ii) of the Act. In
selecting these proposed measures, we
took into account other considerations
listed in section VI.F.1.f.2.. of the
proposed rule. Specifically, fwe
proposed to include the following
measures for reporting under the 2012
Physician Quality Reporting System
because the measures impact chronic
conditions:
• Chronic Wound Care: Use of
Wound Surface Culture Technique in
Patients with Chronic Skin Ulcers.
• Chronic Wound Care: Use of Wet to
Dry Dressings in Patients with Chronic
Skin Ulcers.
• Hypertension: Blood Pressure
Control.
We proposed the following measures
because these measures involve care
coordination:
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• Coronary Artery Disease (CAD):
Symptom Management.
We proposed the following measures
for reporting under the Physician
Quality Reporting System because these
measures are applicable across care
settings:
• Substance Use Disorders:
Counseling Regarding Psychosocial and
Pharmacologic Treatment Options for
Alcohol Dependence.
• Substance Use Disorders: Screening
for Depression Among Patients with
Substance Abuse or Dependence.
• Cardiac Rehabilitation Patient
Referral From an Outpatient Setting.
We proposed (76 FR 42864) the
following measures because we believe
the measures address gaps in the
Physician Quality Reporting System
measure set:
• Barrett’s Esophagus.
• Ultrasound Determination of
Pregnancy Location for Pregnant
Patients with Abdominal Pain.
• Rh Immunoglobulin (Rhogam) for
Rh Negative Pregnant Women at Risk of
Fetal Blood Exposure.
• Surveillance after Endovascular
Abdominal Aortic Aneurysm Repair
(EVAR).
• Referral for Otology Evaluation for
Patients with Acute or Chronic
Dizziness.
• Image Confirmation of Successful
Excision of Image–Localized Breast
Lesion.
• Improvement in Patient’s Visual
Function within 90–Days Following
Cataract Surgery.
• Patient Satisfaction within 90–Days
Following Cataract Surgery.
We proposed the following measures
because we believe the measures
increase the scope of applicability of the
Physician Quality Reporting System
measures to services furnished to
Medicare beneficiaries and expand
opportunities for eligible professionals
to participate in the Physician Quality
Reporting System:
• Radical Prostatectomy Pathology
Reporting.
• Immunohistochemical (IHC)
Evaluation of HER2 for Breast Cancer
Patients .
We proposed the following measures
because the measures are high impact
and support CMS and HHS priorities for
improved quality and efficiency of care
for Medicare beneficiaries.
• Statin Therapy at Discharge after
Lower Extremity Bypass (LEB).
• Rate of Open AAA Repair without
Major Complications (discharged to
home no later than post-operative day
#7).
• Rate of EVAR without Major
Complications (discharged to home no
later than POD #2).
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• Rate of Carotid Endarterectomy for
Asymptomatic Patients, without Major
Complications (discharged to home no
later than post-operative day #2).
We proposed the following measures
because the measures have a high
impact on health care:
• Preoperative Diagnosis of Breast
Cancer.
• Sentinel Lymph Node Biopsy for
Invasive Breast Cancer.
• Biopsy Follow-up.
Of these newly proposed 26 measures,
13 would be reportable via registry-only.
The remaining 13 measures would be
available for claims and registry
reporting. Although we proposed to
designate certain measures as registryonly measures, we indicated we could
not guarantee that there would be a
registry qualified to submit each
registry-only measure for 2012. We rely
on registries to self-nominate and
identify the measures for which they
would like to be qualified to submit
quality measures results and numerator
and denominator data on quality
measures. If no registry self-nominates
to submit measure results and
numerator and denominator data on a
particular measure for 2012, then an
eligible professional would not be able
to report that particular measure.
We believe that the addition of
Physician Quality Reporting System
quality measures will encourage eligible
professionals to participate in the
Physician Quality Reporting System, as
there are more measures that may be
applicable to eligible professionals.
We invited public comment on the
proposed 2012 Physician Quality
Reporting System individual quality
measures that are available for claims
and/or registry-based reporting
identified in Table 30 of the proposed
rule (76 FR 42865). The following is a
summary of the comments we received.
Comment: One commenter supported
the inclusion of all 2011 Physician
Quality Reporting System individual
quality measures available for claims
and registry-based reporting. Several
commenters supported the following
proposed 2012 Physician Quality
Reporting System individual measures
available for claims and/or registrybased reporting that were available for
reporting in 2011:
• End Stage Renal Disease (ESRD):
Influenza Immunization in Patients with
ESRD.
• End Stage Renal Disease (ESRD):
Plan of Care for Inadequate
Hemodialysis in ESRD Patients.
• End Stage Renal Disease (ESRD):
Plan of Care for Inadequate Peritoneal
Dialysis.
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• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Hip Impairments.
• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Lower Leg, Foot or Ankle
Impairments.
• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Lumbar Spine Impairments.
• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Shoulder Impairments.
• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Elbow, Wrist or Hand
Impairments.
• Functional Deficit: Change in RiskAdjusted Functional Status for Patients
with Neck, Cranium, Mandible,
Thoracic Spine, Ribs, or Other General
Orthopedic Impairments.
• Diabetes Mellitus: Urine Screening
for Microalbumin or Medical Attention
for Nephropathy in Diabetic Patients.
• Hemodialysis Vascular Access
Decision-Making by Surgeon to
Maximize Placement of Autogenous
Arterial Venous (AV) Fistula.
• Referral for Otologic Evaluation for
Patients with Congenital or Traumatic
Deformity of the Ear.
• Measure pair: a. Tobacco Use
Assessment, b. Tobacco Cessation
Intervention.
• Preventive Care and Screening:
Influenza Immunization for Patients ≥
50 Years Old.
• Diabetes Mellitus: Hemoglobin A1c
Poor Control in Diabetes Mellitus.
• Diabetes Mellitus: Low Density
Lipoprotein (LDL–C) Control in Diabetes
Mellitus.
• Diabetes Mellitus: High Blood
Pressure Control in Diabetes Mellitus.
• Heart Failure: AngiotensinConverting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy for Left Ventricular Systolic
Dysfunction (LVSD).
• Coronary Artery Disease (CAD):
Beta-Blocker Therapy for CAD Patients
with Prior Myocardial Infarction (MI).
• Preventive Care and Screening:
Pneumonia Vaccination for Patients 65
Years and Older.
• Coronary Artery Disease (CAD):
Oral Antiplatelet Therapy Prescribed for
Patients with CAD.
• Heart Failure: Beta-Blocker Therapy
for Left Ventricular Systolic Dysfunction
(LVSD).
• Coronary Artery Disease (CAD):
Lipid Control.
• Heart Failure: Warfarin Therapy for
Patients with Atrial Fibrillation.
• Ischemic Vascular Disease (IVD):
Blood Pressure Management.
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• Ischemic Vascular Disease (IVD):
Use of Aspirin or Another
Antithrombotic.
• Endoscopy & Polyp Surveillance:
Colonoscopy Interval for Patients with a
History of Adenomatous Polyps—
Avoidance of Inappropriate Use.
One commenter was opposed to the
measure titled ‘‘End Stage Renal Disease
(ESRD): Influenza Immunization in
Patients with ESRD’’ because the
commenter believes reporting of this
measure will create a higher burden for
dialysis facility staff.
Response: We are finalizing all of the
measures commenters supported, except
for the following measure, because, as
stated previously, the measure is being
retired by the respective measure owner:
• End Stage Renal Disease (ESRD):
Influenza Immunization in Patients with
ESRD
Comment: Several commenters
supported the inclusion of all 26 newly
introduced individual measures for
reporting under the 2012 Physician
Quality Reporting System via the claims
and/or registry-based reporting
mechanisms. Some commenters
supported specific newly proposed 2012
Physician Quality Reporting System
individual quality measures available
for claims and/or registry-based
reporting, such as—
• Substance Use Disorders:
Counseling Regarding Psychosocial and
Pharmacologic Treatment Options for
Alcohol Dependence;
• Substance Use Disorders: Screening
for Depression Among Patients with
Substance Abuse or Dependence;
• Cardiac Rehabilitation Patient
Referral From an Outpatient Setting;
• Immunohistochemical (IHC)
Evaluation of HER2 for Breast Cancer
Patients;
• Image Confirmation of Successful
Excision of Image-Localized Breast
Lesion;
• Preoperative Diagnosis of Breast
Cancer;
• Sentinel Lymph Node Biopsy for
Invasive Breast Cancer;
• Biopsy Follow-up;
• Barrett’s Esophagus;
• Radical Prostatectomy Pathology
Reporting;
• Immunohistochemical (IHC)
Evaluation of HER2 for Breast Cancer
Patients;
• Substance Use Disorders:
Counseling Regarding Psychosocial and
Pharmacologic Treatment Options for
Alcohol Dependence; and
• Substance Use Disorders: Screening
for Depression Among Patients with
Substance Abuse or Dependence.
Response: We appreciate the
commenters’ support and are finalizing
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these newly-proposed 26 measures
specified previously as 2012 Physician
Quality Reporting System quality
measures available for claims and/or
registry-based reporting.
Comment: A few commenters noted
that the following measures that we
indicated were not NQF-endorsed in the
proposed rule (76 FR 42864), in fact,
received NQF endorsement:
• Cardiac Rehabilitation Patient
Referral From an Outpatient Setting.
• Ultrasound Determination of
Pregnancy Location for Pregnant
Patients with Abdominal Pain.
• Rh Immunoglobulin (Rhogam) for
Rh Negative Pregnant Women at Risk of
Fetal Blood Exposure.
One commenter also requested that
the measure titled ‘‘Rh Immunoglobulin
(Rhogam) for Rh Negative Pregnant
Women at Risk of Fetal Blood
Exposure’’ be also be reported via
claims, rather than only via the registrybased reporting mechanism.
Response: We appreciate the
commenters’ comment and note that
these measures are endorsed by the
NQF. Therefore, we are finalizing these
measures for reporting via the claims
and/or registry-based reporting
mechanism for the 2012 Physician
Quality Reporting System. The
corresponding NQF numbers for these
measures are indicated in the following
Table 47. Furthermore, ’since we agree
with the commenter, we are allowing
the reporting of the measure titled ‘‘Rh
Immunoglobulin (Rhogam) for Rh
Negative Pregnant Women at Risk of
Fetal Blood Exposure’’ to also be
reported via claims as well as registry.
Comment: With respect to the
measure titled ‘‘Patient Satisfaction
within 90 Days Following Cataract
Surgery’’, one commenter wondered
whether there was an alternative NQFendorsed measure that may be reported
to indicate patient satisfaction.
Response: An alternative NQFendorsed measure addressing patient
satisfaction was not submitted for
possible inclusion in the 2012 Physician
Quality Reporting System. We also note
that the measure is to be reported
whether or not the patient was satisfied
with their care. Rather, the measure
analytics will calculate the percentage
of patients who were satisfied or not
satisfied with their care.
Comment: Some commenters
suggested that all measures be
reportable via claims, at least for the
first year in which the measure is
introduced for reporting in the
Physician Quality Reporting System.
One commenter suggested that we
reconsider the inclusion of measures
that are only reportable via a registry
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that is only open to certain eligible
professionals.
Response: We appreciate the
commenters’ feedback. However, some
measures are not conducive to
collection via claims because they may
require data that is not available at the
time a claim form is submitted. For
example, some outcome measures that
look at complications which may occur
within a specific post-operative period
would be difficult to collect from
claims. In bundled or global payments,
there may not be additional claims
coming to CMS with charges in which
the eligible professional could report a
complication. Other measures can be
difficult to collect via claims due to
their complexity. Additionally, each
year one or more registries request being
vetted (qualified) to report on any and
all Physician Quality Reporting System
measures which would give a specific
specialty an opportunity to report any
new measures.
In addition, we understand the
concern that certain eligible
professionals may not be able to report
on registry-only measures. However, we
believe it is beneficial that we provide
as many measures as possible on which
eligible professionals may report so as to
increase participation and eligible
professionals’ reporting success rates.
We believe the inclusion of registry-only
measures provides a greater set of
measures on which to satisfactorily
report.
Comment: One commenter suggested
that we update the following 2011
Physician Quality Reporting System
measure titles to reflect their new
measure titles:
• Measure #7: Coronary Artery
Disease (CAD): Beta-Blocker TherapyPrior Myocardial Infarction (MI) or Left
Ventricular Systolic Dysfunction (LVEF
< 40 percent).
• Measure #53: Asthma:
Pharmacologic Therapy for Persistent
Asthma.
• Measure #64: Asthma: Assessment
of Asthma Control.
• Measure #81: Adult Kidney Disease:
Hemodialysis Adequacy: Solute.
• Measure #82: Adult Kidney Disease:
Peritoneal Dialysis Adequacy: Solute.
• Measure #32: Stroke and Stroke
Rehabilitation: Discharged on
Antithrombotic Therapy.
• Measure #36: Stroke and Stroke
Rehabilitation: Rehabilitation Services
Ordered.
• Measure #224: Melanoma:
Overutilization of Imaging Studies in
Melanoma.
• Measure #121: Adult Kidney
Disease: Laboratory Testing (Lipid
Profile).
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• Measure #122: Adult Kidney
Disease: Blood Pressure Management.
• Measure #123: Adult Kidney
Disease: Patients on ErythropoiesisStimulating Agent (ESA) Hemoglobin
Level > 12.0 g/dL.
• Measure #197: Coronary Artery
Disease (CAD): Lipid Control.
• Measure #110: Preventive Care and
Screening: Influenza Immunization.
Response: We appreciate the
commenter’s feedback and are finalizing
these measures for reporting under the
Physician Quality Reporting System.
The updated measure titles for
Physician Quality Reporting System
measure #s 7, 53, 64, 81, 82, 32, 36, 224,
and 121 are provided in our final list of
measures identified in Tables 48 and 49
as well as in Tables 50 through 71,
which contain our final 2012 Physician
Quality Reporting System measures
groups.
Comment: One commenter expressed
concern that we are retiring the measure
titled ‘‘End Stage Renal Disease (ESRD):
Plan of Care for Inadequate
Hemodialysis in ESRD Patients’’ due to
its lack of endorsement by the NQF.
Response: We are not retiring this
measure, which is Physician Quality
Reporting System measure # 81. As we
stated previously, however, we are
updating the title of this measure to
‘‘Adult Kidney Disease: Hemodialysis
Adequacy: Solute.’’
Comment: One commenter suggested
that we correct the title to Physician
Quality Reporting System measure
# 186 as the measure is titled ‘‘Chronic
Wound Care: Use of Compression
System in Patients with Venous Ulcers.’’
Response: We appreciate the
commenter’s feedback and are updating
this measure title in our list of finalized
measures in the following Table 47.
Comment: One commenter suggested
that we update Physician Quality
Reporting System measures # 5, 8, and
198 to reflect new joint copyright
between the AMA–PCPI and ACC.
Another commenter suggested that we
update Physician Quality Reporting
System measures # 53, 64, 224, and 231
to reflect new joint copyright ownership
between the AMA–PCPI and NCQA.
Another commenter suggested that we
update Physician Quality Reporting
System measures # 6, 7, 118, 196, and
197 to reflect new joint copyright
ownership between the AMA–PCPI and
AHA.
Response: We appreciate the
commenter’s’ feedback will reflect these
changes in copyright ownership in all of
these measures, which are listed in
Tables 48 and 49.
Comment: One commenter suggested
that we update the description of
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Physician Quality Reporting System
measure # 108 and # 117 to reflect the
correct measure developers, who are
AMA–PCPI/NCQA and NCQ
respectively.
Response: We appreciate the
commenter’s feedback and are updating
the measure descriptions of Physician
Quality Reporting System measures
# 108 and # 117 accordingly.
Comment: One commenter stated that
Physician Quality Reporting System
measures # 67, 68, 69, and 70 state the
measures’ clinical topic, hematology.
Response: We appreciate the
commenter’s feedback and will include
the measures’ clinical topic,
hematology, in the measure titles for
Physician Quality Reporting System
measures # 108 and 117 in the finalized
measures listed in the following Tables
48 and 49.
Comment: One commenter suggested
that we retire the following measure that
we proposed for reporting via claims,
registry, and/or EHR-based reporting
under the 2012 Physician Quality
Reporting System: Physician Quality
Reporting System #200: Heart Failure:
Warfarin Therapy for Patients with
Atrial Fibrillation because the
commenter claims the use of warfarin
therapy to treat Atrial Fibrillation is no
longer consistent with evidence-based
clinical guidelines.
Response: We agree that the Physician
Quality Reporting System quality
measure #200 is no longer consistent
with the evidence-based clinical
guidelines. However, we believe it is
important to retain this measure for the
EHR-based reporting mechanism for the
2012 Physician Quality Reporting
System in order to align with the EHR
Incentive Program. Therefore, as
specified in the following Table 48, we
are only finalizing this measure for
reporting under the EHR-based
reporting mechanism only. We note that
the measure owner has modified the
measure specifications of Physician
Quality Reporting System quality
measure #200 to allow for the use of
additional therapies that are more
consistent with the updated guidelines.
We note that, for future program years,
we will revisit the inclusion of this
measure in the Physician Quality
Reporting System and EHR Incentive
Program. We emphasize our belief that
eligible professionals should follow
standard clinical guidelines related to
the treatment of Atrial Fibrillation.
Comment: One commenter suggested
that we retire the following measure that
we proposed for reporting via claims
and/or registry under the 2012
Physician Quality Reporting System:
Measure #6, which the commenter
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described as ’’Use of High RiskMedications in the Elderly,’’ because the
commenter believes that the measure
may not represent the most up-to-date
evidence-based clinical guidelines.
Response: We appreciate the
commenter’s feedback. However,
Physician Quality Reporting System
measure #6 is ‘‘Coronary Artery Disease
(CAD): Antiplatelet Therapy,’’ not ‘‘Use
of High Risk-Medications in the
Elderly.’’ ‘‘Use of High Risk-Medications
in the Elderly’’ is not a measure that we
proposed for inclusion in the 2012
Physician Quality Reporting System.
For 2012, we are finalizing Physician
Quality Reporting System measure #6
for reporting via claims and/or registry.
Comment: One commenter opposed
the inclusion of the following newly
proposed 2012 Physician Quality
Reporting System individual measures:
• Chronic Wound Care: Use of
Wound Surface Culture Technique in
Patients with Chronic Skin Ulcers.
• Chronic Wound Care: Use of Wet to
Dry Dressings in Patients with Chronic
Skin Ulcers.
The commenter believes that these
measures will encourage eligible
professionals to use more expensive
dressings without improving quality of
care.
Response: We appreciate the
commenter’s feedback. However, we
believe these measures will create a
positive impact to on providing care to
patients with chronic wounds. We
encourage the commenter to review the
revised measure specifications within
the Physician Quality Reporting System.
These measures are calculated as
‘‘inverse’’ measures. Therefore, a lower
rate indicates a better performance/
control or quality indicator.
For the reasons stated previously, we
proposed to include, but are not
finalizing, the following measures for
claims and/or registry-based reporting
in the 2012 Physician Quality Reporting
System:
• # 135: Chronic Kidney Disease
(CKD): Influenza Immunization.
• # 79: End Stage Renal Disease
(ESRD): Influenza immunization in
Patients with ESRD.
• # 175: Pediatric Stage Renal Disease
(ESRD): Influenza Immunization.
Furthermore, as shown in the
following Table 47, we are not finalizing
the following measures for the following
reasons:
• Physician Quality Reporting System
measure #94 titled ‘‘Otitis Media with
Effusion (OME): Diagnostic
Evaluation—Assessment of Tympanic
Membrane Mobility’’: this measure
underwent NQF review, but did not
receive endorsement from the NQF.
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• Physician Quality Reporting System
measure #153 titled ‘‘Chronic Kidney
Disease (CKD): Referral for
Arteriovenous (AV) Fistula’’: this
measure owner has removed this
measure for purposes of quality
reporting.
• Physician Quality Reporting System
measure #202 titled ‘‘Ischemic Vascular
Disease (IVD): Complete Lipid Profile’’
and Physician Quality Reporting System
measure #203 titled ‘‘Ischemic Vascular
Disease (IVD): Low Density Lipoprotein
(LDL–C) Control’’: these measures have
been combined into a single measure
titled ‘‘Ischemic Vascular Disease (IVD):
Complete Lipid Profile and LDL Control
< 100.’’ This combined measure was
listed in Table 55 of the proposed rule.
This new individual measure (see Table
47) titled ‘‘Ischemic Vascular Disease
(IVD): Complete Lipid Profile and LDL
Control < 100’’ will be available for
claims and registry-based reporting.
Based on the comments received and
for the reasons stated previously, we are
finalizing all measures in Table 47 for
claims and/or registry-based reporting
in the 2012 Physician Quality Reporting
System. We proposed (76 FR 42877) an
Epilepsy measures group for inclusion
in the 2012 Physician Quality Reporting
System. As described in further detail
later in this section, we are not
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finalizing the proposed Epilepsy
measures group. However, we are still
finalizing three of the measures from
this measures group for reporting as
individual measures. Table 47 lists a
total of 240 individual measures
available for claims and/or registrybased reporting under the 2012
Physician Quality Reporting System.
We note that the final measures
available for claims and/or registrybased reporting listed in Table 47 that
do not have NQF measure numbers (as
indicated by ‘‘N/A’’) are not currently
endorsed by the NQF. These measures
are awaiting review and endorsement by
the NQF. Therefore, for these measures,
for reasons previously explained, we are
exercising our authority under section
1848(k)(2)(C)(i) of the Act to include
these measures for reporting via the
claims and/or registry-based reporting
mechanisms.
The 2012 Physician Quality Reporting
System individual measures for either
claims-based reporting or registry-based
reporting are listed in Table 47 by their
Physician Quality Reporting System
Measure Number (to the extent the
measure is part of the 2011 Physician
Quality Reporting System measure set)
and Title, along with the name of the
measure’s developer/owner and NQF
measure number, if applicable. The
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Physician Quality Reporting System
Measure Number is a unique identifier
assigned by CMS to all measures in the
Physician Quality Reporting System
measure set. Once a Physician Quality
Reporting System Measure Number is
assigned to a measure, it will not be
used again to identify a different
measure, even if the original measure to
which the number was assigned is
subsequently retired from the Physician
Quality Reporting System measure set.
A description of the measures listed in
Table 47 can be found in the ‘‘2011
Physician Quality Reporting System
Quality Measures List,’’ which is
available on the Measures and Codes
page of the Physician Quality Reporting
System section of the CMS Web site at
https://www.cms.hhs.gov/PQRS to the
extent the measure is part of the 2011
Physician Quality Reporting System
measure set. New measures that we are
adding to the Physician Quality
Reporting System measure set for 2012
are designated with a Physician Quality
Reporting System Measure Number of
‘‘TBD.’’ As we stated previously, the
final 2012 Physician Quality Reporting
System core measures are also listed in
Table 47.
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(C) 2012 Measures Available for EHRBased Reporting
For 2012, we proposed (76 FR 42871)
to again accept Physician Quality
Reporting System data from EHRs for a
limited subset of 2012 Physician Quality
Reporting System quality measures.
Section 1848(m)(7) of the Act
(‘‘Integration of Physician Quality
Reporting and EHR Reporting’’), as
added by section 3002(d) of the
Affordable Care Act, requires that by no
later than January 1, 2012, the Secretary
shall develop a plan to integrate
reporting on quality measures under the
Physician Quality Reporting System
with reporting requirements under the
EHR Incentive Program under section
1848(o) of the Act relating to the
meaningful use of EHRs. Such
integration shall consist of the
following:
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(A) The selection of measures, the
reporting of which would both
demonstrate—
(i) Meaningful use of an EHR for
purposes of the Medicare EHR Incentive
Program; and
(ii) Quality of care furnished to an
individual; and
(B) Such other activities as specified
by the Secretary.
To align the Physician Quality
Reporting System with the Medicare
EHR Incentive Program, we proposed
(76 FR 42871) to include all clinical
quality measures available for reporting
under the Medicare EHR Incentive
Program (75 FR 44398 through 44408)
-in the 2012 Physician Quality
Reporting System for purposes of
reporting data on quality measures
under the EHR-based reporting option.
In 2011, we included 14 of the 44 EHR
Incentive Program measures under the
2011 Physician Quality Reporting
System EHR reporting mechanism. In
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order to better align Physician Quality
Reporting System measures with those
under the EHR Incentive Program, for
2012, we proposed to have the rest of
the 44 clinical quality measures in the
Medicare EHR Incentive Program
available for EHR-based reporting under
the 2012 Physician Quality Reporting
System.
Furthermore, for 2012, we proposed
to retain the following 6 additional
measures that were available for
reporting under the EHR-based
reporting mechanism under the 2011
Physician Quality Reporting System:
• Measure # 39: Screening or Therapy
for Osteoporosis for Women Aged 65
Years and Older.
• Measure # 47: Advance Care Plan.
• Measure # 48: Urinary
Incontinence: Assessment of Presence or
Absence of Urinary Incontinence in
Women Aged 65 Years and Older.
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• Measure # 124: Health Information
Technology (HIT): Adoption/Use of
Electronic Health Records (EHR).
• Measure # 173: Preventive Care and
Screening: Unhealthy Alcohol Use—
Screening.
• Measure # 238: Drugs to be Avoided
in the Elderly.
We believe these measures meet the
criteria listed previously for inclusion
for reporting under the Physician
Quality Reporting System.
We invited public comment on the
proposed EHR-based individual quality
measures available for reporting under
the 2012 Physician Quality Reporting
System. The following is a summary of
the comments we received.
Comment: Several commenters
support the inclusion of all 44 EHR
measures that are also available for
reporting under the EHR Incentive
Program in order to align reporting
requirements and options for the
Physician Quality Reporting System and
EHR Incentive Program.
Response: We appreciate the
commenters’ support and are finalizing
the inclusion of all 44 EHR measures
that are also available for reporting
under the EHR Incentive Program as
2012 Physician Quality Reporting
System measures available for EHRbased reporting.
Comment: Some commenters
supported the following specific
proposed 2012 Physician Quality
Reporting System measures available for
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EHR-based reporting as they address
important medical topics:
• Preventive Care and Screening:
Body Mass Index (BMI) Screening and
Follow-up
• Hypertension (HTN): Blood
Pressure Measurement
• Measure pair: a. Tobacco Use
Assessment, b. Tobacco Cessation
Intervention
• Preventive Care and Screening:
Influenza Immunization for Patients ≥
50 Years Old
• Diabetes Mellitus: Low Density
Lipoprotein (LDL–C) Control in Diabetes
Mellitus
• Heart Failure: AngiotensinConverting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy for Left Ventricular Systolic
Dysfunction (LVSD)
• Coronary Artery Disease (CAD):
Oral Antiplatelet Therapy Prescribed for
Patients with CAD
• Heart Failure: Warfarin Therapy for
Patients with Atrial Fibrillation
• Ischemic Vascular Disease (IVD):
Blood Pressure Management
• Ischemic Vascular Disease (IVD):
Use of Aspirin or Another
Antithrombotic
Response: We appreciate the
commenters’ feedback and are finalizing
all of the measures commenters
supported for EHR-based reporting for
the 2012 Physician Quality Reporting
System.
Comment: One commenter suggested
that we collaborate with NQF to develop
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health information technology-based
quality measures.
Response: With respect to EHR
measures that we have adopted from the
EHR Incentive Program, we note that we
are collaborating with NQF to develop
these quality measures.
Comment: One commenter suggested
that all commonly reported Physician
Quality Reporting System measures be
available for EHR-based reporting.
Response: We appreciate the
commenter’s feedback. However, each
measure’s method of reporting is
determined by the measure owners and
developers. Therefore, we cannot affect
the method in which measures may be
reported.
We proposed to include but are not
finalizing the following measure for
EHR-based reporting in the 2012
Physician Quality Reporting System,
because we believe that use of electronic
health records is already addressed in
most of the measures we are finalizing:
• ‘‘Health Information Technology:
Adoption/Use of Electronic Health
Records’’
Based on the comments received and
for the reasons stated previously, we are
finalizing the 70 measures identified in
Table 48 for EHR-based reporting under
the 2012 Physician Quality Reporting
System. As we stated previously, the
final 2012 Physician Quality Reporting
System core measures are also listed in
Table 48.
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(4) 2012 Physician Quality Reporting
System Measures Groups
We proposed (76 FR 42873) to retain
the following 14 2011 Physician Quality
Reporting System measures groups for
the 2012 Physician Quality Reporting
System: (1) Diabetes Mellitus; (2) Adult
Kidney Disease (formerly CKD); (3)
Preventive Care; (4) CABG; (5)
Rheumatoid Arthritis; (6) Perioperative
Care; (7) Back Pain; (8) CAD; (9) Heart
Failure; (10) IVD; (11) Hepatitis C; (12)
HIV/AIDS; (13) CAP, and (14) Asthma.
For 2012, we proposed that the CABG,
CAD, Heart Failure, and HIV/AIDS
measures groups would continue to be
reportable through the registry-based
reporting mechanism only, while the
remaining Diabetes Mellitus, CKD,
Preventive Care, Rheumatoid Arthritis,
Perioperative Care, Back Pain, IVD,
Hepatitis C, CAP, and Asthma measures
groups would continue to be reportable
through either claims-based reporting or
registry-based reporting. We proposed to
retain these measures groups for the
2012 Physician Quality Reporting
System particularly because we believe
the measures groups reflect the services
furnished to beneficiaries by a particular
specialty. We also believe that retaining
these measures groups would provide
consistency from program year to
program year.
In addition to the 14 measures groups
previously discussed, we proposed (76
FR 42873 through 42879) the following
10 new measures groups for 2012 to
provide eligible professionals with more
measures groups on which to report:
• Chronic Obstructive Pulmonary
Disease (COPD).
• Inflammatory Bowel Disease.
• Sleep Apnea.
• Epilepsy.
• Dementia.
• Parkinson’s.
• Elevated Blood Pressure.
• Radiology.
• Cardiovascular Prevention, which
contains individual measures from the
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core measure set previously discussed.
• Cataracts.
These are the measures groups that
were presented to us by measure owners
and developers for inclusion for
reporting under the 2012 Physician
Quality Reporting System. Section
1848(k)(2)(C)(ii) of the Act provides an
exception to the requirement that
measures be endorsed by the NQF. We
may exercise this exception authority in
a specified area or medical topic for
which a feasible and practical measure
has not been endorsed by NQF, so long
as due consideration is given to
measures that have been endorsed by
the NQF. For the measures contained
within these measures groups that are
not currently NQF-endorsed, we
proposed to exercise this authority due
to our interest in all of the proposed 10
measures group’s topics. We believe that
each of these additional measures
groups address gaps in the Physician
Quality Reporting System measures
groups and will also allow for greater
reporting options for individual eligible
professionals, thereby increasing
participation in the Physician Quality
Reporting System.
Finally, as in previous program years,
for 2012, we proposed (76 FR 42873)
that the measures included in any
proposed 2012 measures group be
reportable either as individual measures
or as part of a measures group, except
for the Back Pain measures group,
which would continue to be reportable
only as part of a measures group and not
as individual measures in 2012.
As with measures group reporting in
prior program years, we proposed that
each eligible professional electing to
report a group of measures for 2012
must report all measures in the group
that are applicable to each patient or
encounter to which the measures group
applies at least up to the minimum
number of patients required by the
applicable reporting criteria.
We invited public comment on our
proposed retention of all 2011 Physician
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Quality Reporting System measures
groups, as well as our newly proposed
measures groups for the 2012 Physician
Quality Reporting System. The
following is a summary of the comments
received that were related to the
proposed 2012 Physician Quality
Reporting System measures groups.
Comment: Some commenters
supported our proposal to continue the
measures group method of reporting.
Response: We believe that reporting
measures in this manner will allow us
to collect information on patient
experience and care that related to a
particular disease.
Comment: Some commenters
supported the following measures
groups for inclusion as a 2012 Physician
Quality Reporting System measures
group because they address important
medical topics: Coronary Artery
Disease; Heart Failure; Sleep Apnea;
Hepatitis C; Elevated Blood Pressure;
Epilepsy; Hypertension; Cardiovascular
Prevention; Cataracts; Parkinson’s;
Diabetes; Dementia; and Radiology.
Response: We appreciate the
commenters’ feedback and are finalizing
all of the proposed measures groups for
the 2012 Physician Quality Reporting
System, except for the Epilepsy
measures group and Radiology measures
group. With respect to the Epilepsy
measures group, 2 of the proposed 5
measures under this measures group did
not receive NQF-endorsement. Since
these measures have undergone review
by the NQF but did not receive
endorsement, we are not finalizing these
measures for the 2012 Physician Quality
Reporting System. Because a measures
group must contain at least 4 measures,
we are not finalizing the Epilepsy
measures group. However, we are
retaining the remaining 3 measures in
the proposed Epilepsy measures group
for reporting as individual measures via
the claims and/or registry-based
reporting mechanisms. With respect to
the Radiology measures group, the
measure owner withdrew the measure
group for consideration as a 2012
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Physician Quality Reporting System
measures group.
Furthermore, we note that, although
we are finalizing the Parkinson’s
measures group, we are not finalizing
the following measure contained within
this measures group because the
measure was reviewed by NQF but not
endorsed: Parkinson’s Disease Medical
and Surgical Treatment Options.
Although we are finalizing the
Elevated Blood Pressure measures
group, we are not finalizing the
following measures contained within
this measures group because, because
these measures differ from other
Physician Quality Reporting System
measures in that they are survey-based;
therefore, it is not operationally feasible
for us to analyze data collected under
these measures:
• Overall Hypertension Care
Satisfaction
• Patient Self-care Support
Comment: Some commenters made
specific suggestions to the proposed
2012 Radiology measures group, such as
renaming the Radiology measures
group, reducing the number of measures
contained within the Radiology
measures group, reconsidering the
measures contained with the Radiology
measures group so that the measures
contained in this measures group have
similar denominators, and splitting the
Radiology measures group into two
Radiology measures groups.
Response: We appreciate the
commenters’ feedback. However, as we
noted previously, we are not finalizing
the Radiology measures group for 2012,
because the Radiology measures group
was withdrawn by the measure owner
for consideration as a 2012 Physician
Quality Reporting System measures
group.
Comment: One commenter suggested
that the Pulmonary Rehabilitation
measures group that was submitted for
possible inclusion as a 2012 Physician
Quality Reporting System measures
group be included as a 2012 Physician
Quality Reporting System measures
group.
Response: We reviewed all measures
groups that were submitted for possible
inclusion as a 2012 Physician Quality
Reporting System measures group,
including the Pulmonary Rehabilitation
measures group. Upon review of the
measures and feedback received from
the NQF, 2 of the 5 proposed measures
contained within the Pulmonary
Rehabilitation measures group did not
pass review, thereby leaving only 3
measures available for reporting under
the Pulmonary Rehabilitation measures
group. Since a Physician Quality
Reporting System measures group must
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consist of at least 4 measures, the
Pulmonary Rehabilitation measures
group no longer contained enough
measures to be classified as a Physician
Quality Reporting System measures
group. However, we are interested in
including a pulmonary rehabilitation
measures group and encourage
professional organizations and measure
developers to submit such a measures
group for inclusion as a Physician
Quality Reporting System in future
program years.
Comment: One commenter suggested
that the measure titled ‘‘Counseling for
Women’’ be included in the Epilepsy
measures group.
Response: We appreciate the
commenter’s feedback. However, as we
stated previously, we are not finalizing
the Epilepsy measures group inclusion
under the 2012 Physician Quality
Reporting System.
Comment: Several commenters urged
us to have all measures contained
within these measures groups also
available for reporting as individual
measures. Some commenters requested
that all measures contained within
specific measures groups, such as
Radiology and IBD, be reportable as
individual Physician Quality Reporting
System measures.
Response: We proposed (76 FR 42873)
that measures included in the Back Pain
measures group will not be available for
reporting as individual measures.
Although we proposed that measures
contained within the proposed 2012
Physician Quality Reporting System
measures groups also be available for
individual reporting, except for the
COPD measures group (which contains
2011 Physician Quality Reporting
System measures that were previously
available for reporting as individual
measures), we are not allowing any
measures contained in either the back
pain measures group or any of the
newly finalized 2012 Physician Quality
Reporting System measures groups to be
reportable as individual measures,
unless a measure contained in a
measures group has been identified as a
2012 Physician Quality Reporting
System individual measure in Table 47.
Some of the measures contained in the
finalized measures groups do not lend
themselves to reporting as individual
measures. Therefore, for 2012, only
measures contained in the following
measures groups will be available for
reporting as individual measures:
Diabetes Mellitus; Adult Kidney
Disease; Preventive Care; CABG;
Rheumatoid Arthritis; Perioperative
Care; CAD; Heart Failure; IVD; Hepatitis
C; HIV/AIDS; CAP, Asthma;
Cardiovascular Prevention; and COPD.
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Comment: Some commenters
suggested that all measures groups be
reported via claims and registry, such as
the Dementia measures group. One
commenter suggested that the
Parkinson’s and Dementia measures
groups be reportable via claims as well
as registry, since there are currently no
registries which report on these
measures groups, at least until registries
for these conditions become available.
Response: Reporting methods are
chosen based on the most effective way
to accurately collect data needed to
calculate the measure. Due to the
limitations of claims-based reporting,
some measures are reportable only
through a registry. Due to the way the
measures within these measures groups
are analyzed, the Dementia and
Parkinson’s measures groups fall within
this category of measures groups that
cannot be reported via claims. With
respect to the Parkinson’s and Dementia
measures groups, although no registries
are currently qualified to report on these
measures groups, we anticipate that
qualified registries will be available to
report on these measures for the 2012
Physician Quality Reporting System.
Therefore, the Dementia and
Parkinson’s measures groups may only
be reportable via registry.
Comment: Some commenters
suggested that we ensure that there is an
analytically sound method to grouping
measures within measures groups,
particularly when measure
denominators differ.
Response: We appreciate the
commenters’ feedback and agree that
ensuring accurate reporting analysis is
essential. As in prior years, the
reporting rate calculations for the 2012
Physician Quality Reporting System
will only include instances that qualify
for the denominator of the respective
measure. When denominators differ for
measures within a measures group,
eligible professionals will not be held
accountable for reporting on measures
that are not applicable for purposes of
the requiring that eligible professionals
report on measures with a performance
rate other than zero. However, eligible
professionals are still required to report
on these measures. The performance
rate calculation only includes
denominator eligible and successfully
reported instances, so the requirement
to have each measure within the group
have a performance rate above zero
percent will not be adversely affected by
instances that are not denominator
eligible.
Comment: One commenter suggested
that we remove the following measure
from the Radiology measures group:
Cumulative Count of Potential High
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Dose Radiation Imaging Studies: CT
Scans and Cardiac Nuclear Medicine
Scans. The commenter believes that
removing this measure will allow for the
measure denominators of the measures
contained within the Radiology
measures group to consistent with the
use of CT scans alone.
Response: We appreciate the
commenter’s feedback and interest in
aligning the measure denominators
contained within the Radiology
measures group. However, because the
measure owner has withdrawn this
measures group for consideration for
reporting under the 2012 Physician
Quality Reporting System, we are not
finalizing the proposed Radiology
measures group.
Comment: Several commenters
suggested that we include or develop
other measures groups that were not
proposed as a 2012 Physician Quality
Reporting System measures group, such
as: Oncology, Stroke, Cardiac Imaging,
Colorectal Cancer, Thyroid Disease,
Pain Management, Physical Therapy,
Colorectal Cancer Screening, and Cancer
Care.
Response: We appreciate the
commenter’s feedback. However,
because we did not propose these
measures groups for inclusion in the
2012 Physician Quality Reporting
System and there was not opportunity
for the public to comment on these
measures, we are not finalizing any of
these suggestions. However, we will
take these measures group’s suggestions
into consideration for future program
years.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing the measures groups
that are identified in Tables 50 through
71. As we explained previously, we are
finalizing all proposed 2012 Physician
Quality Reporting System measures
groups, except for the Epilepsy and
Radiology measures groups.
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We also note that, although we are
finalizing these measures groups, we
have made the following changes to
these final 2012 Physician Quality
Reporting System measures groups:
• Adult Kidney Disease measures
group: As indicated in Table 50, we are
not finalizing Physician Quality
Reporting System #153 titled ‘‘Chronic
Kidney Disease (CKD): Referral for
Arteriovenous (AV) Fistula’’ for
reporting in this measures group
because, as we stated previously, the
measure owner has removed this
measure for reporting in 2012. Instead,
we are adding Physician Quality
Reporting System measure #110 titled
‘‘Preventive Care and Screening:
Influenza Immunization’’ for reporting
within the Adult Kidney Disease
measures group.
• IVD measures group: As indicated
in Table 58, we are not finalizing
Physician Quality Reporting System
measures #202 titled ‘‘Ischemic
Vascular Disease (IVD): Complete Lipid
Profile’’ and #203 titled ‘‘Ischemic
Vascular Disease (IVD): Low Density
Lipoprotein (LDL–C)’’ for reporting in
the IVD measures group. As stated
previously, these two measures have
been combined into a single measure
titled ‘‘Ischemic Vascular Disease (IVD):
Complete Lipid Profile and LDL Control
< 100.’’ Therefore, instead of reporting
measures #202 and #203, we are
requiring that eligible professionals
report on this new measure in the IVD
measures group.
• IBD Measures Group: As indicated
in Table 64, we are updating measure
title ‘‘Inflammatory Bowel Disease
(IBD): Assessment of Inflammatory
Bowel Disease Activity and Severity’’ to
‘‘Inflammatory Bowel Disease: Type
Anatomic Location and Activity All
Documented’’ as the measure owner has
updated the title of this measure.
• Parkinson’s Measures Group: As
indicated in Table 67, we are not
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finalizing the measure titled
‘‘Parkinson’s Disease Related Safety
Issues Counseling’’ for reporting within
the Parkinson’s measures group.
• Elevated Blood Pressure: As
indicated in Table 68, we are not
finalizing the measures titled ‘‘Overall
Hypertension Care Satisfaction’’ and
‘‘Patient Self-care Support’’ for reporting
within this measures group.
Some measures in the 2012 measures
groups are also 2011 individual
Physician Quality Reporting System
measures. Specifically, measures
contained in the following measures
groups will be available for reporting as
individual measures: Diabetes Mellitus;
Adult Kidney Disease; Preventive Care;
CABG; Rheumatoid Arthritis;
Perioperative Care; CAD; Heart Failure;
IVD; Hepatitis C; HIV/AIDS; CAP, and
Asthma.
The title of each such measure is
preceded with its Physician Quality
Reporting System Measure Number in
Tables 50 through 71. As stated
previously, the Physician Quality
Reporting System Measure Number is a
unique identifier assigned by us to all
measures in the Physician Quality
Reporting System measure set. Once a
Physician Quality Reporting System
Measure Number is assigned to a
measure, it will not be used again, even
if the measure is subsequently retired
from the Physician Quality Reporting
System measure set. Measures that are
not preceded by a number (in other
words, those preceded by ‘‘TBD’’) in
Tables 50 through 71 were never part of
a Physician Quality Reporting System
measure set prior to 2012. A number
will be assigned to such measures for
2012. Furthermore, please note that, in
some instances, the measure titles have
been updated to reflect measure title
updates by the respective measure
owners.
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As with measures group reporting in
prior years of the Physician Quality
Reporting System, each eligible
professional electing to report a group of
measures for 2012 must report all
measures in the group that are
applicable to each patient or encounter
to which the measures group applies at
least up to the minimum number of
patients required by the applicable
reporting criteria. We note that the
specifications for measures groups do
not necessarily contain all the
specification elements of each
individual measure making up the
measures group. This is based on the
need for a common set of denominator
specifications for all the measures
making up a measures group in order to
define the applicability of the measures
group. Therefore, the specifications and
instructions for measures groups will be
provided separately from the
specifications and instructions for the
individual 2012 Physician Quality
Reporting System measures. We will
post the detailed specifications and
specific instructions for reporting
measures groups on the Physician
Quality Reporting System section of the
CMS Web site at https://
www.cms.hhs.gov/PQRS by no later
than December 31, 2011.
Additionally, the detailed measure
specifications and instructions for
submitting data on these 2012 measures
groups that were also included as 2011
Physician Quality Reporting System
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measures groups may be updated or
modified by the measure developer
prior to 2012. Therefore, the 2012
Physician Quality Reporting System
measure specifications for any given
measures group could be different from
specifications and submission
instructions for the same measures
group used for 2011. For example, the
measure developer may change the
codes contained in the measure’s
denominator. These measure
specification changes do not materially
impact the intended meaning of the
measures or the strength of the
measures.
(5) 2012 Physician Quality Reporting
System Quality Measures for Group
Practices Selected To Participate in the
GPRO (GPRO)
For 2012, we proposed (76 FR 42879)
that group practices selected to
participate in the 2012 Physician
Quality Reporting System GPRO would
be required to report on 41 proposed
measures listed in Table 55 of the
proposed rule. Specifically, for the 2012
Physician Quality Reporting System, we
proposed to retain most of the measures
available for reporting under the 2011
Physician Quality Reporting System
GPRO because of our continued interest
in the reporting of those measures, as
well as to maintain program consistency
from year to year. However, for 2012, we
proposed to retire the following
measures that were required under the
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2010 and 2011 GPRO (that is, GPRO I
for 2011):
• Diabetes Mellitus: Hemoglobin A1c
Testing.
• Diabetes Mellitus: Lipid Profile
• Hypertension (HTN): Blood
Pressure Measurement.
Furthermore, we proposed to add the
following Physician Quality core
measures that were not available for
reporting via the GPRO for the 2011
Physician Quality Reporting System:
• Ischemic Vascular Disease (IVD):
Use of Aspirin or another
Antithrombotic.
• Measure pair: a. Tobacco Use
Assessment, b. Tobacco Cessation
Intervention.
• Ischemic Vascular Disease (IVD):
Complete Lipid Profile and LDL Control
< 100
• Proportion of adults 18 years and
older who have had their blood pressure
measured within the preceding 2-years.
In addition to adding the Physician
Quality Reporting System core measures
that were not available for reporting
under the GPRO for the 2011 Physician
Quality Reporting System, we proposed
to add the following measures for
reporting under the 2012 Physician
Quality Reporting System GPRO:
• Chronic Obstructive Pulmonary
Disease (COPD): Bronchodilator
Therapy.
• Adult Weight Screening and
Follow-up.
• Ischemic Vascular Disease (IVD):
Blood Pressure Management Control.
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• Chronic Obstructive Pulmonary
Disease (COPD): Spirometry Evaluation.
• 30 Day Post Discharge Physician
Visit.
• Medication Reconciliation:
Reconciliation After Discharge from an
Inpatient Facility.
• Diabetes: Aspirin Use.
• Falls: Screening for Fall Risk.
• Osteoporosis: Management
Following Fracture of Hip, Spine or
Distal Radius for Men and Women Aged
50 Years and Older.
• Diabetes Mellitus: Tobacco Non
Use.
• Coronary Artery Disease (CAD):
LDL-level < 100 mg/dl.
• Diabetes Mellitus: Hemoglobin A1c
Poor Control in Diabetes Mellitus (less
than 8 percent).
• Chronic Obstructive Pulmonary
Disease (COPD): Smoking Cessation
Counseling Received.
• Monthly International Normalized
Ratio (INR) for Beneficiaries on
Warfarin.
We proposed (76 FR 42879) these new
measures because they are NQFendorsed measures that are consistent
with other CMS quality reporting
initiatives. We believe it is in the
stakeholders’ interest to align measures
in different initiatives. We proposed
that group practices selected to
participate in the Physician Quality
Reporting System GPRO would be
required to report on all measures listed
in Table 55.
We invited public comment on the
proposed 2012 Physician Quality
Reporting System measures for group
practices selected to participate in the
2012 Physician Quality Reporting
System GPRO. The following is a
summary of the comments we received.
Comment: Some commenters
suggested we retain the following 3
measures that we proposed to retire for
the 2012 Physician Quality Reporting
System GPRO because they address
important medical topics relevant to the
commenters’ respective specialties:
• Diabetes Mellitus: Hemoglobin A1c
Testing;
• Diabetes Mellitus: Lipid Profile; and
• Hypertension (HTN): Blood
Pressure Measurement.
Response: We appreciate the
commenters’ feedback. However, as
stated previously, due to our desire to
align these 2012 Physician Quality
Reporting System GPRO measures with
other CMS programs, we are retiring
these measures.
Comments: Several commenters
supported inclusion of the following
measures as reportable measures for
physician groups participating in the
2012 Physician Quality Reporting
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System GPRO because they either
addressed important medical topics
relevant to the commenters’ respective
specialties and/or they are measures
included in other CMS programs:
• Measure pair: a. Tobacco Use
Assessment, b. Tobacco Cessation
Intervention.
• Ischemic Vascular Disease (IVD):
Blood Pressure Management Control.
• Adult Weigh Screening and Followup.
• Medication Reconciliation:
Reconciliation After Discharge from an
Inpatient Facility.
• Diabetes: Aspirin Use.
• Diabetes Mellitus: Tobacco NonUse.
• Coronary Artery Disease (CAD):
LDL-level < 100 mg/dl.
• Diabetes Mellitus: Hemoglobin A1c
Poor Control in Diabetes Mellitus
(<8%).
• Monthly INR for Beneficiaries on
Warfarin.
• Diabetes Mellitus: Dilated Eye Exam
in Diabetic Patient.
• Coronary Artery Disease (CAD):
Beta-Blocker Therapy for CAD Patients
with Prior Myocardial Infarction (MI).
• Ischemic Vascular Disease (IVD):
Blood Pressure Management.
Response: ‘In an effort to reduce the
number of measures group practices
report under the GPRO we proposed so
that the number of measures required
for reporting are closer to 26, which is
the number of measures available for
reporting under the Physician Quality
Reporting System GPRO I in 2011 (76
FR 73537), we are finalizing all of the
measures for inclusion in the 2012
Physician Quality Reporting System
GPRO measure set, except for the
following measures:
• Ischemic Vascular Disease (IVD):
Blood Pressure Management Control.
• Coronary Artery Disease (CAD):
LDL-level < 100 mg/dl.
• Coronary Artery Disease (CAD):
Beta-Blocker Therapy for CAD Patients
with Prior Myocardial Infarction (MI).
We are not retaining these measures
because we seek to align the Physician
Quality Reporting System GPRO with
the Medicare Shared Savings Program.
These measures were not included for
reporting under the Medicare Shared
Savings Program (‘‘Medicare Program;
Medicare Shared Savings Program:
Accountable Care Organizations’’
displayed in the October 20, 2011
Federal Register at https://www.ofr.gov/
OFRUpload/OFRData/201127461_PI.pdf.
Also due to our desire to align the
measures available for reporting under
the 2012 Physician Quality Reporting
System GPRO with the measures
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available for reporting under the
Medicare Shared Savings Program, we
are not finalizing the following
measures in the 2012 Physician Quality
Reporting System GPRO measure set:
• Diabetes Mellitus: Urine Screening
for Microalbumin for Medical Attention
for Nephropathy in Diabetic Patients.
• Heart Failure: Weight Measurement.
• Heart Failure: Patient Education.
• Hypertension (HTN): Plan of Care.
• Chronic Obstructive Pulmonary
Disease (COPD): Spirometry Evaluation.
• Ischemic Vascular Disease (IVD):
Use of Aspirin of another
Antithrombotic.
• 30-Day Post Discharge Physician
Visit.
• Osteoporosis: Management
Following Fracture of Hip, Spine or
Distal Radius for Men and Women Aged
50 Years and Older.
• Coronary Artery Disease (CAD):
LDL-level < 100 mg/dl.
• Chronic Obstructive Pulmonary
Disease (COPD): Smoking Cessation
Counseling Received.
We believe our effort to align various
CMS programs will encourage
participation in the Physician Quality
Reporting System. Since increasing
participation in the Physician Quality
Reporting System is a top priority, we
believe our desire to align various CMS
programs outweighs our interest in
maintaining measures that were
previously available for reporting under
the Physician Quality Reporting System.
We further believe that the measures
that we finalize for reporting under the
2012 Physician Quality Reporting
System GPRO, as identified in Table 71,
sufficiently address the conditions and
care measured by the measures we are
not finalizing.
Comment: One commenter stated that,
since group practices participating in
the Physician Quality Reporting System
GPRO must report on all measures listed
in Table 71, only NQF-endorsed
measures should be included for
reporting by physician groups
participating in the 2012 Physician
Quality Reporting System GPRO.
Response: We appreciate the
commenter’s feedback. We note that,
unlike the criteria for satisfactory
reporting for individual eligible
professionals, group practices may
report measures with a zero percent
performance rate. Therefore, it does not
harm group practices participating
under the GPRO to report on the
measures we are finalizing for the
GPRO, regardless of whether the
measures are NQF-endorsed. We also
note that we have authority under
section 1848(k)(2)(C)(ii) of the Act to
select measures that are not NQF-
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endorsed. We believe the non-NQF
endorsed measures we are finalizing
below address critical areas of health
care.
Comment: One commenter urged us
to minimize the reporting burden on
group practices by reducing the number
of measures on which group practices
participating in the Physician Quality
Reporting System may report.
Response: As stated previously, we
are only finalizing 30 of the 40 measures
we proposed. We hope this will notably
reduce the reporting burden on group
practices participating in the Physician
Quality Reporting System GPRO.
Comment: One commenter was
concerned that the reporting of the
measure titled ‘‘Monthly INR for
Beneficiaries on Warfarin’’ will have the
unintended consequence of having
eligible professionals avoid patients
who are non-compliant with treatment
recommendations.
Response: We agree that the personal
preferences of beneficiaries play an
important role in their health behaviors.
However, the lack of patient adherence
may also represent a legitimate
dimension of care, as it could be
indicative of poor communication
between providers and their patients. As
INR is important for patients on
warfarin, we are retaining this measure
as proposed. In addition, as discussed in
the public reporting requirements in
section VI.G. of this final rule with
comment period, we believe publicly
reporting certain measures provides
greater incentive for providers to
coordinate care and influence patient
behavior.
Comment: One commenter opposed
our proposal to retire the measure titled
‘‘Plan of Care for Inadequate
Hemodialysis’’ because the retirement of
this measure will only leave
nephrologists with only one Physician
Quality Reporting System measure on
which to report.
Response: We understand the need to
have adequate number of measures
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available under which eligible
professionals practicing in many
specialties report. In this instance,
however, we do not believe that retiring
this measure for reporting under the
GPRO will affect the ability for eligible
professionals to satisfactorily reporting.
We note that group practices
participating in the GPRO must report
on all measures listed in Table 71,
regardless of whether the measures are
applicable to the group practice.
Comment: One commenter suggested
that the measures available for reporting
under the Physician Quality Reporting
System GPRO include more measures
that pertain to otolaryngologists.
Response: We appreciate the
commenter’s feedback. However, we
give eligible professionals an
opportunity to provide input on
measures recommended for selection
via the proposed rule, and therefore,
additional measures and/or measure
topics cannot be included for reporting
under the 2012 Physician Quality
Reporting System. However, we will
take these GPRO measure suggestions
into consideration for future program
years.
Comment: Some commenters
requested that the measure
specifications for the proposed GPRO
measures be available for review prior to
its inclusion as GPRO measures.
Response: As we stated previously,
we do not use notice and comment
rulemaking as a means to update or
modify measure specifications.
Questions regarding measure
specifications should be directed to the
measure developers, who are all listed
in Table 55 of the proposed rule (76 FR
42880). Contact information for the 2011
Physician Quality Reporting System
measure developers is listed in the
‘‘2011 Physician Quality Reporting
System Quality Measures List,’’ which
is available on the CMS Web site at
https://www.cms.gov/PQRS/
15_MeasuresCodes.asp#TopOfPage.
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Based on the comments received and
for the reasons stated previously, we are
finalizing the 29 measures for physician
groups participating in the 2012
Physician Quality Reporting System
GPRO listed in Table 71. Table 71 also
indicates which measures are also
available for reporting under the
Medicare Shared Savings Program.
We also note that, in an effort to align
the 2012 Physician Quality Reporting
System GPRO measures with the
measures available for group reporting
under the Medicare Shared Savings
Program, we are not finalizing the
following measures for the 2012
Physician Quality Reporting System
GPRO:
• Coronary Artery Disease (CAD):
Beta-Blocker Therapy for CAD Patients
with Prior Myocardial Infarction (MI)
• Diabetes Mellitus: Urine Screening
for Microalbumin or Medical Attention
for Nephropathy in Diabetic Patients
• Heart Failure: Weight Measurement
• Hypertension (HTN): Plan of Care
• Ischemic Vascular Disease (IVD):
Blood Pressure Management Control
• Chronic Obstructive Pulmonary
Disease (COPD): Spirometry Evaluation
• 30–Day Post Discharge Physician
Visit
• Osteoperosis: Management
Following Fracture of Hip, Spine or
Distal Radius for Men and Women Aged
50 Years and Older
• Coronary Artery Disease (CAD):
LDL-level < 100 mg/dl
• Chronic Obstructive Pulmonary
Disease (COPD): Smoking Cessation
Counseling Received
• Heart Failure: Warfarin Therapy for
Patients with Atrial Fibrillation
We are also not finalizing the measure
titled ‘‘Monthly INR for Beneficiaries on
Warfarin’’ because, as we stated with
Physician Quality Reporting System
measure #200, the use of Warfarin to
treat heart disease is no longer
consistent with clinical guidelines.
BILLING CODE 4120–01–P
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We intend to provide a separate
measures specifications document and
other supporting documents for group
practices participating in the 2012
Physician Quality Reporting System
GPRO. We anticipate that the group
practice measures specifications
document will be available by
November 15, 2011 or shortly thereafter
on the Physician Quality Reporting
System section of the CMS Web site at
https://www.cms.hhs.gov/PQRS.
g. Maintenance of Certification Program
Incentive
Section 1848(k)(4) of the Act requires
the Secretary to address a mechanism
whereby an eligible professional may
provide data on quality measures
through a maintenance of certification
program (Maintenance of Certification
Program) operated by a specialty body
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of the American Board of Medical
Specialties (ABMS). In addition, section
1848(m)(7) of the Act (‘‘Additional
Incentive Payment’’) authorizes an
additional 0.5 percent incentive
payment for years 2011 through 2014 if
certain requirements are met. In
accordance with section 1848(m)(7)(B)
of the Act governing the ‘‘Additional
Incentive Payment,’’ in order to qualify
for the additional incentive payment, an
eligible professional must—
• Satisfactorily submit data on quality
measures under the Physician Quality
Reporting System for a year and have
such data submitted—
++ On their behalf through a
Maintenance of Certification Program
that meets the criteria for a registry
under the Physician Quality Reporting
System; or
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++ In an alternative form and manner
determined appropriate by the
Secretary; and
++ More frequently than is required
to qualify for or maintain board
certification status:
++ Participate in such a Maintenance
of Certification Program for a year; and
++ Successfully completes a qualified
Maintenance of Certification Program
practice assessment for such year.
Section 1848(m)(7)(C)(i) of the Act
defines ‘‘Maintenance of Certification
Program’’ as a continuous assessment
program, such as a qualified ABMS
Maintenance of Certification Program,
or an equivalent program (as determined
by the Secretary), that advances quality
and the lifelong learning and selfassessment of board certified specialty
physicians by focusing on the
competencies of patient care, medical
knowledge, practice-based learning,
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interpersonal and communications
skills and professionalism. Such a
program shall require a physician to do
the following:
• Maintain a valid, unrestricted
medical license in the United States.
• Participate in educational and selfassessment programs that require an
assessment of what was learned.
• Demonstrate, through a formalized,
secure examination, that the physician
has the fundamental diagnostic skills,
medical knowledge, and clinical
judgment to provide quality care in their
respective specialty.
• Successful completion of a
qualified Maintenance of Certification
Program practice assessment.
As defined in section
1848(m)(7)(C)(ii) of the Act, a ‘‘qualified
Maintenance of Certification Program
practice assessment’’ means an
assessment of a physician’s practice
that—
• Includes an initial assessment of an
eligible professional’s practice that is
designed to demonstrate the physician’s
use of evidence-based medicine;
• Includes a survey of patient
experience with care; and
• Requires a physician to implement
a quality improvement intervention to
address a practice weakness identified
in the initial assessment and then to
remeasure to assess performance after
such intervention.
To qualify for the additional incentive
payment, section 1848(m)(7)(B)(iii) of
the Act also requires the Maintenance of
Certification Program to submit to CMS,
on behalf of the eligible professional,
information:
• In a form and manner specified by
the Secretary, that the eligible
professional more frequently than is
required to qualify for or maintain board
certification status, participates in the
Maintenance of Certification Program
for a year and successfully completes a
qualified Maintenance of Certification
Program practice assessment for such
year;
• Upon request by the Secretary,
information on the survey of patient
experience with care; and
• As the Secretary may require, on
the methods, measures, and data used
under the Maintenance of Certification
Program and the qualified Maintenance
of Certification Program practice
assessment.
In order to qualify for the additional
0.5 percent incentive payment in 2011,
eligible professionals were required to
participate more frequently in each of
the following four parts of the
Maintenance of Certification Program:
• Maintain a valid unrestricted
license in the United States. For 2011,
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physicians simply needed to maintain a
valid unrestricted license in the United
States to meet the requirement for
‘‘more frequent’’ participation with
respect to this part (75 FR 73541
through 73546).
• Participate in educational and selfassessment programs that require an
assessment of what was learned.
• Demonstrate, through a formalized
secure examination, that the physician
has the fundamental diagnostic skills,
medical knowledge, and clinical
judgment to provide quality care in their
respective specialty.
• Successfully complete a qualified
maintenance of certification program
practice assessment.
We received requests from the
American Board of Medical Specialties,
as well as various specialty
organizations, to revise the criteria for
satisfying the Maintenance of
Certification Program additional
incentive, because these entities believe
that more frequent participation in all
four parts of the Maintenance of
Certification Program is too narrow. In
the proposed rule, we noted that we
further considered the language under
section 1848(m)(7)(B)(ii)(I) of the Act
and we believe it can be interpreted
more broadly. In particular, we noted
that the requirement that a professional
‘‘more frequently than is required to
qualify for or maintain board
certification status participates in such
a Maintenance of Certification Program’’
could refer to the program as a whole,
such that any element performed more
frequently than is required satisfies the
general requirement. The nature of the
various components of the Maintenance
of Certification Program also suggest
that it is not necessary that each of the
four elements of the program be
performed more frequently. We
previously stated we believe that the
‘‘more frequently’’ requirement does not
apply to the first part, which states that
a physician maintain a valid
unrestricted license, as there is no way
a physician may maintain a valid
unrestricted license ‘‘more frequently.’’
As such, we believe that the more
frequently requirement could be
satisfied based on any of the other
elements of the program (that is,
educational and self-assessment
program; secure examination; or
practice assessment). Specifically, we
believe that if a professional more
frequently than is required satisfies one
or more of those parts of a program, the
more frequently requirement would be
met. Accordingly, we proposed (76 FR
42881–42882) that in order to earn an
additional 0.5 percent incentive for
2012 through 2014, for each respective
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year, an eligible professional must
participate more frequently than is
required in at least one of the following
three parts of the Maintenance of
Certification Program, as well as ‘‘more
frequent’’ participation in the practice
assessment component. With respect to
how to assess whether a professional
completes one of the elements of a
program ‘‘more frequently,’’ we believe
that this would be tied to the specific
requirements of Board certification for
the professional. Given that different
specialties have different certification
requirements (physician examination
requirements to maintain Board
certification varies widely depending on
specialty), we do not believe it is
appropriate to impose a uniform
requirement for all professionals and
therefore, we believe that the board
could determine for a particular
program element the more frequent
requirement for the professional.
However, we believe that a minimum
threshold would need to be met such
that the professional would have to do
something more frequently or more than
what is ordinarily required for a
particular part of the program, as well
as ‘‘more frequent’’ participation in the
practice assessment component.
Therefore, in order to earn an
additional 0.5 percent incentive for
2012 through 2014, an eligible
professional would be required to
participate more frequently than is
required in at least one of the following
three parts of the Maintenance of
Certification Program, as well as ‘‘more
frequent’’ successful completion of a
qualified maintenance of certification
program practice assessment:
• Maintain a valid unrestricted
license in the United States. For 2011,
physicians simply needed to maintain a
valid unrestricted license in the United
States to meet the requirement for
‘‘more frequent’’ participation with
respect to this part (75 FR 73541
through 73546).
• Participate in educational and selfassessment programs that require an
assessment of what was learned.
• Demonstrate, through a formalized
secure examination, that the physician
has the fundamental diagnostic skills,
medical knowledge, and clinical
judgment to provide quality care in their
respective specialty.
Therefore, we proposed for 2012,
2013, and 2014 the following for each
year (76 FR 42882 and 42883):
• An eligible professional wishing to
be eligible for the additional Physician
Quality Reporting System incentive
payment of 0.5 percent must meet the
requirements for satisfactory reporting
for the Physician Quality Reporting
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System, for the applicable program year
(that is, to qualify for the additional 0.5
percent incentive payment for 2012,
meet the 2012 requirements for
satisfactory reporting), based on the 12month reporting period (January 1
through December 31 of the respective
program year).
• For purposes of satisfactory
reporting under the Physician Quality
Reporting System, we proposed (76 FR
42882) that the eligible professional may
participate as an individual eligible
professional using either individual
Physician Quality Reporting System
measures or measures groups and
submitting the Physician Quality
Reporting System data via claims, a
registry, or an EHR or participate under
the GPRO option. As an alternative to
this reporting option, we proposed that
eligible professionals may satisfactorily
report under the Physician Quality
Reporting System based on submission
of Physician Quality Reporting System
data by a Maintenance of Certification
Program, provided that the Maintenance
of Certification Program has qualified as
a Physician Quality Reporting System
registry for 2012. As indicated
previously, an eligible professional
would not necessarily have to qualify
for the Physician Quality Reporting
System through a Maintenance of
Certification Program serving as a
registry. Rather, we proposed that an
eligible professional may qualify for the
additional incentive, without regard to
the method by which the eligible
professional has met the basic
requirement of satisfactory reporting
under the Physician Quality Reporting
System. We received no comments
regarding our proposal to allow eligible
professionals to qualify for the
additional incentive without regard to
the method by which the eligible
professional has met the basic
requirement of satisfactory reporting
under the Physician Quality Reporting
System and are therefore, we are
finalizing this proposal.
• In addition to meeting the
requirements for satisfactory reporting
for the Physician Quality Reporting
System for a program year, the eligible
professional must have data with
respect to the eligible professional’s
participation in a Maintenance of
Certification Program submitted on his
or her behalf by a qualified medical
specialty board or other entity
sponsoring a Maintenance of
Certification Program. For each eligible
professional that wishes to qualify for
the Maintenance of Certification
Program Incentive, the qualified
medical specialty board or other entity
sponsoring a Maintenance of
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Certification Program must submit data
to CMS with respect to the following:
• An eligible professional must, more
frequently than is required to qualify for
or maintain board certification,
participate in a Maintenance of
Certification Program for a year and
successfully complete a qualified
Maintenance of Certification Program
practice assessment for such year. With
regard to the ‘‘more frequently’’
requirement as it applies to the elements
of a Maintenance of Certification
Program itself (other than completing a
qualified Maintenance of Certification
Program practice assessment), the
Maintenance of Certification Program
must certify that the eligible
professional has ‘‘more frequently’’ than
is required to qualify for or maintain
board certification ‘‘participated in a
Maintenance of Certification Program
for a year’’. The Maintenance of
Certification Program will determine
what a physician must do to more
frequently participate in a Maintenance
of Certification Program and so certify
that the eligible professional has met
this requirement. While we do not
believe that the ‘‘more frequently’’
requirement is applicable to the
licensure requirement, given that one
cannot be licensed ‘‘more frequently’’
than is required, the Maintenance of
Certification Program has the discretion
to determine which element(s) of a
Maintenance of Certification Program
must be completed more frequently. We
believe that making this change will
reduce burden on physicians and will
increase participation while being
consistent with the requirement to
‘‘more frequently’’ participate in a
Maintenance of Certification Program.
• With respect to the Maintenance of
Certification Program practice
assessment, which is specifically
delineated in section 1848(m)(7)(B)(ii)
of the Act as being required more often
than is necessary to qualify for or
maintain board certification, we believe
we need to be more specific regarding
our interpretation of the phrase ‘‘more
frequently.’’ Additionally, we are aware
that some specialty boards have varying
Maintenance of Certification Program
requirements for physicians to maintain
board certification, based on the date of
original certification. Some, we believe,
may not be required to participate in a
Maintenance of Certification Program at
all in order to maintain board
certification. Accordingly, we recognize
that ‘‘more often’’ may vary among
physicians certified by the same
specialty board. We interpret the
statutory provisions as requiring
participation in and successful
completion of at least one Maintenance
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of Certification Program practice
assessment per year. Therefore, as a
basic requirement, the physician must
participate and successfully complete at
least one Maintenance of Certification
Program practice assessment for each
year the physician participates in the
Maintenance of Certification Program
Incentive, regardless of whether or how
often the physician is required to
participate in a Maintenance of
Certification Program to maintain board
certification.
We are also aware that ABMS boards
are at various stages in implementing
the practice assessment modules, and
some may not have such assessment
modules in place. However, inasmuch
as we interpret the statute to require a
Maintenance of Certification Program
practice assessment at least once per
program year as part of the Maintenance
of Certification Program, eligible
professionals who do not have available,
through their boards or otherwise, a
Maintenance of Certification Program
practice assessment are not eligible for
the 0.5 percent incentive.
We believe that the experience of care
survey provides particularly valuable
information and proposed that a
qualified Maintenance of Certification
Program practice assessment must
include a survey of patient experience
with care. The Secretary may request
information on the survey of patient
experience with care, under section
1848(m)(7)(B)(iii) of the Act. In view of
the importance of this information, and
the lack of readily available alternative
sources, we proposed to require that
Maintenance of Certification Programs
submit information about the patient
experience of care survey(s) used by
physicians to fulfill the Maintenance of
Certification Program practice
assessment. We are not, at this time,
requesting the results of the survey for
the eligible professionals for whom
information is being submitted by the
Maintenance of Certification Program.
We may, however, request such
information for appropriate validation
purposes and may propose to request
such data for future years of the
Maintenance of Certification Program
Incentive.
Some Maintenance of Certification
Programs underwent a self-nomination
process in 2011 to enable their members
to be eligible for this Physician Quality
Reporting System Maintenance of
Certification Program Incentive for 2011
Physician Quality Reporting System. We
proposed (76 FR 42883) that a
Maintenance of Certification Program
that was approved after undergoing the
self-nomination process in 2011 must
submit a self-nomination statement for
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each year the Maintenance of
Certification Program intends to
participate in the Physician Quality
Reporting System Maintenance of
Certification Program. In the selfnomination statement, we proposed that
the previously approved program must
provide us with updates to its program
in its self-nomination statement. We
proposed that this self-nomination
statement be submitted to CMS via a
web-based tool. We received no
comments regarding the self-nomination
process for those Maintenance of
Certification Programs that underwent a
self-nomination process in 2011.
Therefore, we are finalizing the
proposed requirements.
For Maintenance of Certification
Programs new for 2012, we proposed
(76 FR 42883) that Maintenance of
Certification Programs wishing to enable
their diplomates to be eligible for an
additional Physician Quality Reporting
System incentive payment for the 2012
Physician Quality Reporting System
would need to go through a selfnomination process by January 31, 2012.
We proposed that the board must
include all of the following information
in their self-nomination statement to us:
• Provide detailed information
regarding the Maintenance of
Certification Program with reference to
the statutory requirements for such
program;
• Indicate the organization
sponsoring the Maintenance of
Certification Program, and whether the
Maintenance of Certification Program is
sponsored by an ABMS board. If not an
ABMS board, indicate whether and how
the program is substantially equivalent
to the ABMS Maintenance of
Certification Program process;
• Indicate that the program is in
existence as of January 1, 2012;
• Indicate that the program has at
least 1 active participant;
• The frequency of a cycle of
Maintenance of Certification Program
for the specific Maintenance of
Certification Program of the sponsoring
organization; including what constitutes
‘‘more frequently’’ for the Maintenance
of Certification Program itself and for
the practice assessment for the specific
Maintenance of Certification Program of
the sponsoring organization;
• Confirmation from the board that
the practice assessment will occur and
be completed in the year the physician
is participating in the Maintenance of
Certification Program Incentive;
• What was, is, or will be the first
year of availability of the Maintenance
of Certification Program practice
assessment for completion by an eligible
professional;
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• What data is collected under the
patient experience of care survey and
how this information would be
provided to CMS;
• Describe how the Maintenance of
Certification Program monitors that an
eligible professional has implemented a
quality improvement process for their
practice; and
• Describe the methods, and data
used under the Maintenance of
Certification Program, and provide a list
of all measures used in the Maintenance
of Certification Program for 2011 and to
be used for 2012, including the title and
descriptions of each measure, the owner
of the measure, whether the measure is
NQF endorsed, and a link to a Web site
containing the detailed specifications of
the measures, or an electronic file
containing the detailed specifications of
the measures.
We proposed (76 FR 42883) that
sponsoring organizations who desire to
participate as a Maintenance of
Certification Program must provide
CMS the following information below in
a CMS-specified file format by no later
than the end of the first quarter of 2012:.
• The name, NPI and applicable
TIN(s) of the eligible professional who
would like to participate in this process;
• Attestation from the board that the
information provided to CMS is
accurate and complete.
• The board has signed
documentation from the eligible
professional that the eligible
professional wishes to have the
information released to us;
• Information from the patient
experience of care survey;
• Information certifying that the
eligible professional has participated in
a Maintenance of Certification Program
for a year, more frequently than is
required to qualify for or maintain board
certification status, including the year
that the physician met the board
certification requirements for the
Maintenance of Certification Program,
and the year the eligible professional
participated in a Maintenance of
Certification Program ‘‘more frequently’’
than is required to maintain or qualify
for board certification; and
• Information certifying that the
eligible professional has completed the
Maintenance of Certification Program
practice assessment at least one time
each year the eligible professional
participates in the Maintenance of
Certification Program Incentive.
We proposed (76 FR 42883) that
specialty boards that also desire to send
Physician Quality Reporting System
information to us on behalf of eligible
professionals must meet the
requirements for registry data
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submission and should follow the
directions for self-nomination to become
a qualified registry. Boards may also
participate as registries for Physician
Quality Reporting System data provided
that they meet the registry requirements.
As an alternative to requiring boards to
either operate a qualified Physician
Quality Reporting System registry or to
self-nominate to submit Maintenance of
Certification Program data to us on
behalf of their members, we proposed to
continue to allow the various boards to
submit the Maintenance of Certification
Program data to the ABMS and having
ABMS submit the information on behalf
of the various boards and their member
eligible professionals to CMS. We
received no comments on our proposed
requirements for specialty boards that
wish to send Physician Quality
Reporting System information to us on
behalf of eligible professionals and
therefore, we are finalizing these
requirements.
To the extent an eligible professional
participates in multiple Maintenance of
Certification Programs and meets the
requirements under section 1848(m)(7)
of the Act (Additional Incentive
Payment) under multiple programs, we
note that the eligible professional can
qualify for only one additional 0.5
percent incentive per year.
We invited public comment on the
requirements we proposed for earning a
0.5 percent incentive for participation in
the Maintenance of Certification
Program incentive. The following is a
summary of the comments we received
related to the Maintenance of
Certification Program incentive.
Comment: Several commenters
generally supported the Maintenance of
Certification Program incentive and the
requirements for earning such an
incentive. One commenter asked
whether or not CMS had a plan to allow
physicians who are not Board-certified
to participate in the Maintenance of
Certification Program Incentive.
Response: We appreciate the
commenters’ support. Currently, we do
not have a plan to allow physicians who
are not Board-certified to participate in
the Maintenance of Certification
Program Incentive, because we defer to
the various specialty boards to specify
the particular actions a physician must
complete to meet the ‘‘more frequently’’
requirement.
Comment: Another commenter asked
that American Osteopathic Association
and its Osteopathic Continuous
Certification (OCC) program(s) be
recognized as equivalent to the
American Board of Medical Specialties
(ABMS) Maintenance of Certification
Programs for the purpose of qualifying
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for a Maintenance of Certification
Program incentive.
Response: We cannot approve an
organization’s certification program for
participation in the Maintenance of
Certification Program incentive unless
the organization meets all of the
requirements we are finalizing.
Comment: One commenter was
opposed to having physicians report
Maintenance of Certification Program
details that they must also report to
hospitals. The commenter suggested
that we eliminate this duplicative
reporting.
Response: Our proposal calls for
Maintenance of Certification data to be
submitted in one of two ways. First, the
data can be submitted directly from the
qualified Maintenance of Certification
Program entity. Secondly, the data can
be submitted by an ABMS Maintenance
of Certification registry, if the ABMS
chooses to proceed down this path. We
do not believe that either of these
mechanisms places additional burden
on the provider, hospitals or specialties
societies.
Comment: Some commenters stated
that the requirements to earn a
Maintenance of Certification Program
incentive are generally too burdensome
for both physicians and medical
specialty boards.
Response: We appreciate the
commenter’s feedback. However, the
general requirements for earning the
Maintenance of Certification Program
incentive are specified in section
1848(m)(7) of the Act. Therefore,
physicians must meet all of the below
requirements to be eligible for a
Maintenance of Certification Program
incentive.
Comment: Several commenters
supported our proposal to reinterpret
the definition of ‘‘more frequently’’ to
apply to one of three parts, in addition
to requiring a practice assessment,
instead of applying to each of the four
parts. Some of these commenters
expressed support in giving the
respective medical specialty boards
more deference in applying the ‘‘more
frequently’’ requirement for earning a
Maintenance of Certification Program
incentive.
Response: Based on the comments we
received and for the reasons we
explained previously, we are finalizing
the ‘‘more frequently’’ requirement for
the Maintenance of Certification
Program incentive.
Comment: Some commenters
supported our decision to refrain from
requiring the reporting of patient
experience of care survey data at this
time.
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Response: We appreciate the
commenters’ feedback and are not
requiring the reporting of patient
experience of care survey data at this
time.
After considering the comments and
for the reasons stated previously, we are
finalizing our proposals regarding the
Maintenance of Certification Program
incentive. We are also finalizing the
requirements for the 2013 and 2014
Maintenance of Certification Program
additional incentive. With respect to
dates specific to the Maintenance of
Certification Program additional
incentive, we are finalizing dates that
correspond to the additional incentive
year. Specifically, new Maintenance of
Certification that wish to enable their
diplomats to be eligible for the
additional Physician Quality Reporting
System 0.5 percent for 2013 and/or 2014
must go through the same nomination
process by January 31, 2013 and January
31, 2014, respectively.
In addition, with respect to its selfnomination statement, a Maintenance of
Certification Program wishing to enable
its diplomats to earn a 2013 and 2014
Maintenance of Certification Program
additional incentive must indicate that
the program is in existence as of January
1, 2012 for the 2012 additional
incentive, January 1, 2013 for the 2013
additional incentive, and January 1,
2014 for the 2014 additional incentive.
With respect to the information required
in the self-nomination statement,
sponsoring organizations that desire to
participate as a Maintenance of
Certification Program must provide this
information to CMS in a CMS-specified
file format by no later than the end of
the first quarter of 2013 and 2014 for the
2014 and 2014 Maintenance of
Certification additional incentive.
h. Feedback Reports
Section 1848(m)(5)(H) of the Act
requires the Secretary to provide timely
feedback to eligible professionals on the
performance of the eligible professional
with respect to satisfactorily submitting
data on quality measures. Since the
inception of the program in 2007, the
Physician Quality Reporting System has
provided eligible professionals who
have reported Physician Quality
Reporting System data on quality
measures feedback reports at the TIN/
NPI level detailing participation in the
Physician Quality Reporting System,
including reporting rate and
performance rate information. For 2008,
we improved the format and content of
feedback reports based on stakeholder
input. We also developed an alternate
report distribution method whereby
each eligible professional can directly
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request and receive a feedback report.
Starting in 2011, we provided an
opportunity for eligible professionals to
request their NPI-level feedback reports
via the Communication Support Page at
https://www.qualitynet.org/portal/
server.pt/community/
communications_support_system/234.
In accordance with Section
1848(m)(5)(H) of the Act, we will
continue to provide feedback reports to
individuals and group practices that
attempt to report on at least one
Physician Quality Reporting System
quality measure. We proposed (76 FR
42884) to provide feedback reports for
2012 and beyond, on or about the time
of issuance of the incentive payments,
consistent with our current practice.
We received the following comment
regarding this proposal.
Comment: One commenter questioned
why annual feedback reports are
provided around the time Physician
Quality Reporting System incentive
payments are distributed.
Response: We disseminate annual
feedback reports at the same time
incentive payments are made so that the
provider has adequate information
available to understand how the
incentive payment was calculated.
Therefore, we will continue to distribute
annual feedback reports around the time
Physician Quality Reporting System
incentive payments are distributed.
Comment: One commenter stated that
we should improve the accessibility of
feedback reports, as eligible
professionals in the past have had
trouble accessing these feedback reports.
Another commenter stated that annual
feedback reports should be distributed
before the issuance of incentive
payments.
Response: We believe that providing
annual feedback reports on or about the
issuance of incentive payments is
timely. However, we would like to
increase accessibility, speed, and ease of
distributing feedback reports to eligible
professionals. Therefore, we are working
with finding other ways, aside from
accessing feedback reports through
Carried/MACs or with the use of an
IACS account. For example, in addition
to being able to access feedback reports
through this traditional method, eligible
professionals may request 2010
Physician Quality Reporting System
NPI-level feedback reports via the
Communication Support Page. We
believe that accessing feedback reports
through the Communication Support
Page is a faster method of receiving
feedback reports. We welcome any
suggestions on improving accessibility
to Physician Quality Reporting System
feedback reports.
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For the reasons stated previously, for
2012 and beyond, we are finalizing our
proposal to provide feedback reports to
individuals and group practices that
attempt to report on at least one
Physician Quality Reporting System
quality measure on or about the time of
issuance of the incentive payments.
In addition, we believe it would be
beneficial for eligible professionals to
also receive interim feedback reports.
Therefore, we proposed (76 FR 42884)
to provide interim feedback reports,
which would be simplified versions of
the feedback reports we currently
provide, to eligible professionals
reporting individual measures and
measures groups through the claimsbased reporting mechanism for 2012
and beyond, and issue them in the
summer of the respective program year.
We believe interim feedback reports
would be particularly valuable to
eligible professionals reporting
measures groups, because it would let
an eligible professional know how many
more cases he or she needs to report to
satisfy the criteria for satisfactory
reporting for claims-based reporting of
measures groups.
We invited public comment on our
proposal to provide interim feedback
reports related to reporting via the
claims-based reporting mechanism for
2012 and beyond. The following is a
summary of comments we received.
Comment: Several commenters
supported our proposal to provide
interim feedback reports. However,
some commenters suggested that we
allow stakeholders to comment on the
form and content of these interim
feedback reports.
Response: We appreciate the
commenters’ support in our proposal to
provide interim feedback reports and
are finalizing our proposal to provide
interim feedback reports for claimsbased reporting for 2012 and beyond.
However, as the form and content of
these feedback reports are already being
developed, we cannot make changes
related to the form and content of these
interim feedback reports for 2012.
However, for interim feedback reports
that will be developed for future
program years, we expect to provide an
opportunity for the public to provide
suggestions regarding the form and
content of these interim feedback
reports.
Comment: Some commenters
suggested that we provide interim
feedback reports that provide reporting
information via other reporting
mechanisms aside from claims, such as
registry and EHR.
Response: We appreciate the
commenters’ feedback. However, since
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we do not receive data from the registry
and EHR reporting mechanisms until
the following calendar year, it is not
technically feasible for us to develop
interim feedback reports that provide
reporting performance related to registry
and/or EHR-based reporting. However,
as stated in previously in section
VI.F.1.d, we are finalizing our proposal
to require registries and EHR vendors to
provide such feedback reports, if
technically feasible.
After considering the issues raised in
the comments we received and for the
reasons stated previously, we are
finalizing our proposal to provide
interim feedback reports for eligible
professionals reporting individual
measures and measures groups through
the claims-based reporting mechanism
for 2012 and beyond. These reports will
be a simplified version of annual
feedback reports that we currently
provide for such eligible professionals
and will be based on claims for dates of
service occurring on or after January 1
and processed by March 31 of the
respective program year (that is, January
1, 2012 and processed by March 31,
2012 for the 2012 program year). We
expect that we would be able to make
these interim feedback reports available
to eligible professionals in the summer
of the respective program year (that is,
summer 2012 for the 2012 program
year).
i. Informal Review
Under 42 CFR 414.90(i), eligible
professionals or group practices may
seek an informal review of the
determination that the eligible
professional or group practice did not
satisfactorily submit data on quality
measures under the Physician Quality
Reporting System.
To maintain program consistency
until we have further experience with
the informal review process that we
implemented for the 2011 Physician
Quality Reporting System, we proposed
(76 FR 42884) to largely retain the same
informal review process that was
finalized in the 2011 MPFS final rule
with comment period (75 FR 73549
through 73551) for 2012 and beyond.
Specifically, we proposed to base the
informal process on our current inquiry
process whereby an eligible professional
can contact the Quality Net Help Desk
(Help Desk) (via phone or email) for
general Physician Quality Reporting
System and eRx Incentive Program
information, information on Physician
Quality Reporting System feedback
report availability and access, and/or
information on Physician Quality
Reporting System Portal password
issues.
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For purposes of the informal process
required under section 1848(m)(5)(E) of
the Act, we proposed the following
inquiry process:
• An eligible professional electing to
utilize the informal process must
request an informal review within 90
days of the release of his or her feedback
report, irrespective of when an eligible
professional actually accesses his/her
feedback report.
• An eligible professional may
request an informal review through use
of a web-based tool, if technically
feasible. We believe use of the webbased tool will provide a more efficient
way to record informal review requests,
as the web-based tool will guide the
eligible professional through the
creation of an informal review requests.
For example, the web-based tool will
prompt an eligible professional of any
necessary information s/he must
provide. If not technically feasible, we
proposed that an eligible professional
may request the informal review by
notifying the Quality Net Help Desk via
email at qnetsupport@sdps.org. In the
request for an informal review, the
eligible professional must summarize
his or her concern(s) of the eligible
professional and the reason(s) for
requesting an informal review.
• We further proposed (76 FR 42884)
that CMS would provide the eligible
professional with a response to his or
her request for an informal review
within 90 days of receiving the original
request. In 2011, we proposed to
provide the eligible professional with a
response to his or her request for an
informal review within 60 days of
receiving the original request. However,
we anticipate that the volume of
informal review requests will grow as
participation in the Physician Quality
Reporting System grows, particularly as
we move towards the implementation of
the 2015 payment adjustment.
Furthermore, we believe that the time it
takes for CMS to calculate data on
Physician Quality Reporting System
quality measures will be greater than in
2011, since we are proposing additional
individual measures and measures
groups. For these reasons, we proposed
to amend 42 CFR 414.90(i)(2) to indicate
that CMS will provide a written
response within 90 days of the receipt
of the original request for an informal
review.
• As this process is informal and the
statute does not require a formal appeals
process, we will not include a hearing
or evidence submission process,
although the eligible professional may
submit information to assist in the
review.
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• Based on our informal review, we
will provide a written response. Where
we find that the eligible professional did
satisfactorily report, we proposed to
provide the applicable incentive
payment.
• Given that this is an informal
review process and given the limitations
on review under section 1848(m)(5)(E)
of the Act, decisions based on the
informal review will be final, and there
will be no further review or appeal.
We invited public comment on the
proposed informal review process for
2012 and beyond. The following is a
summary of the comments regarding the
informal review process.
Comment: Some commenters were
opposed to our proposal to extend the
time CMS must provide a response to
the eligible professional’s request for an
informal review from 60 days to 90
days. One commenter acknowledged
CMS anticipating a higher volume of
informal review requests, but the
commenter stated that 90 days was too
long of a waiting period for eligible
professionals to receive a response to
their request for an informal review.
Another commenter stated that
extending the time CMS must provide a
response does not provide eligible
professionals with the opportunity to
make a second request for a review
within the 90 day window that eligible
professionals are given to request an
informal review.
Response: We appreciate the
commenter’s feedback. However, as we
stated previously, we anticipate a higher
volume of requests for informal review,
particularly as we move towards the
2015 payment adjustment and continue
to align with various CMS programs to
encourage participation in the Physician
Quality Reporting System. We believe
that the time it takes for CMS to
calculate data on Physician Quality
Reporting System quality measures will
be greater than in 2011, since we are
proposing additional individual
measures and measures groups. With
respect to being able to request a second
review, we note that all informal review
decisions are final. Eligible
professionals will not have the
opportunity to request a second review.
Therefore, for the reasons we noted, we
are finalizing our proposal to extend the
time CMS must provide a response to
the eligible professional’s request for an
informal review from 60 days to 90
days.
Comment: One commenter urged us
to create a hearing of evidentiary
process to allow eligible professionals to
submit additional evidence.
Response: As stated previously, we
did not establish a hearing or
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evidentiary process because this review
is informal. We understand that, in
some instances, an eligible professional
may need to provide additional
information. Therefore, should we need
additional information to process a
request for an informal review, we will
request this additional information. We
note, however, that the need for
additional information will not affect
the deadline for CMS to provide a
decision to the eligible professional.
Comment: One commenter was
concerned with our proposal to use the
Help Desk as the basis for our informal
review process, because the commenter
stated that practices have had
difficulties obtaining reliable
information from the Help Desk.
Response: We appreciate the
commenter’s feedback. However, the
webbased tool is the finalized method
under which we are accepting requests
for informal review. The Help Desk,
however, will perform informal review
functions related to analysis of the
informal review. We believe the
informal review process, using the webbased tool in conjunction with the Help
Desk, is the most efficient and most
beneficial to the eligible professional.
With respect to the commenter’s
concern that the Help Desk may provide
inaccurate information, we will monitor
the Help Desk for accuracy of the
information provided.
Based on the comments received and
for the reasons stated previously, for
2012 and beyond, we are finalizing the
Physician Quality Reporting System
informal review process, as proposed.
Eligible professionals wishing to submit
a request for an informal review are
required to do so via a web-based tool,
the Communication Support Page.
Information on the Communication
Support Page, including the link to the
Page, will be available at https://
www.cms.gov/PQRS//. Eligible
professionals who have difficulty
accessing the Communication Support
Page, such as those eligible
professionals who do not have internet
access, may contact the Help Desk for
assistance in submitting a request for an
informal review. We also note that, with
respect to informal reviews for the 2011
Physician Quality Reporting System, we
stated (75 FR 73550) that eligible
professionals wishing to submit a
request for an informal review do so by
submitting an email to the QualityNet
Help Desk at qnetsupport@sdps.org. As
we believe that submitting the informal
review request via a web-based tool is
a more efficient and secure method of
receiving these informal review
requests, we are also allowing use of the
web-based tool to submit informal
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review requests for the 2011 Physician
Quality Reporting System. We are
finalizing our proposal to modify 42
CFR 414.90 to reflect these finalized
proposals.
j. Future Payment Adjustments for the
Physician Quality Reporting System
Beginning in 2015, a payment
adjustment will apply under the
Physician Quality Reporting System.
Specifically, under section 1848(a)(8) of
the Act, as added by section 3002(b) of
the Affordable Care Act, with respect to
covered professional services furnished
by an eligible professional during 2015
or any subsequent year, if the eligible
professional does not satisfactorily
submit 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 professionals during
the year shall be equal to the applicable
percent of the fee schedule amount that
would otherwise apply to such services.
The applicable percent is—
• 98.5 percent for 2015; and
• 98.0 percent for 2016 and each
subsequent year.
Under section 1848(a)(8)(C)(iii) of the
Act provides that, for purposes of the
payment adjustment, the ‘‘quality
reporting period’’ with the respect to a
year, is a period specified by the
Secretary. In order to maintain
consistency and program continuity,
similar to the 12-month reporting period
we are proposed for 2012, we proposed
a 12-month reporting period for the
2015 payment adjustment. Specifically,
in the proposed rule, we proposed (76
FR 42884–42885) that the reporting
period for purposes of the 2015 payment
adjustment would be the 2013 calendar
year, that is, January 1, 2013 through
December 31, 2013.
Comment: Several commenters
opposed our proposal to establish CY
2013 as the reporting period for the
2015 payment adjustment, because they
felt the report period for the 2015
payment adjustment should occur later
in time. These commenters believed that
the reporting period for the 2015
payment adjustment should mirror the
reporting periods for the Physician
Quality Reporting System incentives
(i.e., a CY 2012 reporting period for the
2012 incentive). Some commenters
suggested CY 2014 or CY 2015 as the
reporting period for the 2015 payment
adjustment. One commenter urged us to
align the reporting periods for Physician
Quality Reporting System incentives as
well as payment adjustments as closely
as possible.
Response: We considered using a CY
2014 and CY 2015 reporting period for
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the 2015 payment adjustment. However,
it is not operationally feasible to create
a full calendar year reporting period for
the 2015 payment adjustment any later
than CY 2013 and still avoid retroactive
payments or the reprocessing of claims.
Section 1848(a)(8) of the Act requires
that a payment adjustment be applied to
covered professional services furnished
by an eligible professional in in the
particular payment adjustment year.
Therefore, using 2015 as an example, we
believe it is necessary to reduce the PFS
amount concurrently for PFS allowed
charges for covered professional
services furnished in 2015. If we do not
reduce the PFS amount concurrently
with claims submissions in 2015, we
would need to potentially recoup or
provide added payments after the
determination is made about whether
the payment adjustment applies, or
alternatively, hold claims until such a
determination is made. In addition, we
note that if such retroactive adjustments
were made it may require a
reconciliation of beneficiary copayments. As a result, we need to
determine whether eligible
professionals have satisfactorily
reported under the Physician Quality
Reporting System based on a reporting
period that occurs prior to 2015.
As for the suggestion that we use CY
2014 as the reporting period, we do not
believe this would allow sufficient time
for eligible professionals to report the
Physician Quality reporting System
measures, or allow us enough time to
collect and analyze the data submitted
by eligible professionals in order to
avoid retroactive adjustments to
payments in 2015, because we will not
receive this data until months after the
reporting period. Once we have
completed our analysis, we also need
time to make the necessary system
changes to begin applying the payment
adjustments to the appropriate
individuals. All of this must occur prior
to January 1, 2015, and so using a CY
2014 reporting period would not be
feasible. We believe that the reporting
period we proposed will allow a full
calendar year for eligible professionals
(which is consistent with the reporting
periods finalized for the 2012 incentive)
to meet the criteria for satisfactory
reporting for purposes of the 2015
payment adjustment, while still
providing us with enough time to
collect and analyze the data submitted
by eligible professionals for the 2015
payment adjustment without having to
make retroactive payment adjustments
in 2015. With regard to using a shorter
reporting period (that is, less than 12
months), we may consider, in future
notice and comment rulemaking,
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additional reporting periods that are less
than 12 months for the 2015 payment
adjustment, so that eligible
professionals have additional
opportunities to meet the requirements
for the 2015 payment adjustment.
Therefore, for the reasons we’ve
explained, we are finalizing our
proposal to establish CY 2013 (that is,
January 1, 2013 through December 31,
2013) as the reporting period for the
2015 payment adjustment. At this time,
we are not aware of any viable
alternatives that would allow us to
address the issues we noted and still
provide a full-year reporting period that
falls after 2013. We will, however,
continue to explore options for
potentially using a reporting period
closer to the time in which the payment
adjustment is applied for future years of
the payment adjustment.
Based on the reporting period we are
finalizing in this final rule with
comment period, if we determine that
an eligible professional or group
practice has not satisfactorily reported
data on quality measures for the January
1, 2013 through December 31, 2013
reporting period for purposes of the
2015 payment adjustment, then the fee
schedule amount for services furnished
by the eligible professional or group
practice during 2015 would be 98.5
percent of the fee schedule amount that
would otherwise apply to such services.
We intend to address the remaining
requirements for the 2015 payment
adjustment in future rulemaking.
2. Incentives and Payment Adjustments
for Electronic Prescribing (eRx)—The
Electronic Prescribing Incentive
Program
a. Program Background and Statutory
Authority
Electronic prescribing is the
transmission using electronic media, of
prescription or prescription-related
information between the prescriber,
dispenser, pharmacy benefit manager
(PBM), or health plan, either directly or
through an intermediary, including an
electronic prescribing network. To
encourage the use of electronic
prescribing among eligible
professionals, section 132 of the
Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA) amended
section 1848(m) of the Act to establish
the eRx Incentive Program. The eRx
Incentive Program provides a
combination of incentive payments and
payment adjustments through 2014 to
eligible professionals who are successful
electronic prescribers. No eRx incentive
payments or payment adjustments are
authorized beyond 2014.
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From 2009 through 2013, the
Secretary is authorized to provide
eligible professionals who are successful
electronic prescribers an incentive
payment equal to a percentage of the
eligible professional’s total estimated
Medicare Part B PFS allowed charges
(based on claims submitted not later
than 2 months after the end of the
reporting period) for all covered
professional services furnished by the
eligible professional during the
respective reporting period. However,
section 1848(m)(2)(D) of the Act, as
added by section 4101(f)(2)(B) of Title
IV of Division B of the American
Recovery and Reinvestment Act of 2009
(Pub. L. 111–5) (ARRA), which also
authorized the Medicare EHR Incentive
Program, specifies that the eRx
incentive does not apply to an eligible
professional, if, for the EHR reporting
period, the eligible professional earns an
incentive payment under the Medicare
EHR Incentive Program beginning in
2011.
The applicable electronic prescribing
percent for incentive payments under
the eRx Incentive Program are as
follows:
• 2.0 percent for 2009.
• 2.0 percent for 2010.
• 1.0 percent for 2011.
• 1.0 percent for 2012.
• 0.5 percent for 2013.
In addition, for years 2012 through
2014, under section 1848(a)(5)(A) of the
Act, a PFS payment adjustment applies
to eligible professionals who are not
successful electronic prescribers at an
increasing rate through 2014.
Specifically, if the eligible professional
is not a successful electronic prescriber
for the respective reporting period for
the year, the PFS amount for covered
professional services during the year
shall be a percentage less than the PFS
amount that would otherwise apply.
The applicable electronic prescribing
percent for payment adjustments under
the eRx Incentive Program are as
follows:
• 1.0 percent in 2012.
• 1.5 percent in 2013.
• 2.0 percent in 2014.
We believe the purpose of the eRx
Incentive Program for 2012 and beyond
is to continue to encourage significant
expansion of electronic prescribing by
authorizing a combination of financial
incentives and payment adjustments.
We proposed to modify the incentive
and payment adjustment language in 42
CFR 414.92 to provide language more
consistent with section 1848 of the Act
(please note that in the proposed rule
we inadvertently listed ‘‘section
1848(k)’’ instead of ‘‘section 1848’’).
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We believe that the criteria used to
determine who is a successful electronic
prescriber for purposes of the eRx
incentive are not required to be
identical to the criteria used to
determine the applicability of the eRx
payment adjustment. In general, we
believe that an incentive should be
broadly available to encourage the
widest possible adoption of electronic
prescribing, even for low volume
prescribers. On the other hand, we
believe that a payment adjustment
should be applied primarily to assure
that those who have a large volume of
prescribing do so electronically, without
penalizing those for whom the adoption
and use of an electronic prescribing
system may be impractical given the
low volume of prescribing. We also
believe that eligible professionals who
have met the requirements for receiving
an incentive payment under the eRx
Incentive Program for a particular year
have sufficiently demonstrated their
adoption and use of electronic
prescribing technology and thus should
not be subject to the payment
adjustment in a future year.
Individual eligible professionals do
not have to participate in the Physician
Quality Reporting System in order to
participate in the eRx Incentive Program
(and vice versa). The provisions of the
eRx Incentive Program are codified at 42
CFR 414.92.
In prior years, we have proposed and
finalized the details of the eRx Incentive
Program through an annual rulemaking
process. Through this annual
rulemaking process, we have previously
established the criteria for avoiding the
2012 eRx payment adjustment in the
2011 PFS Final Rule with comment
period (75 FR 73562 through 73565), as
well as issued a final rule entitled
‘‘Changes to the Electronic Prescribing
(eRx) Incentive Program’’ (76 FR 54953
through 54969), in which we proposed
additional changes to the 2012 payment
adjustment, as well as the electronic
prescribing quality measure for certain
reporting periods in 2011. We also
established requirements for the 2013
eRx payment adjustment in the 2011
PFS Final Rule with comment period
(75 FR 7356).
In this final rule with comment
period, we are finalizing our
comprehensive requirements for the
2012 and 2013 incentive payments,
additional requirements for the 2013
payment adjustment, and requirements
for the 2014 payment adjustment. We
believe that finalizing criteria for the
eRx Incentive Program for 2012 and
beyond will provide eligible
professionals with more time to
familiarize themselves with the details
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of the eRx Incentive Program. We hope
this will lead to increased, successful
participation in the eRx Incentive
Program. Details regarding requirements
for the eRx Incentive Program for 2012
and 2013 incentive payments,
additional requirements for the 2013
payment adjustment, and the
requirements for the 2014 payment
adjustment, including our rationale for
finalizing such requirements, are
described in the following section. We
received comments that were not related
to our specific proposals for the 2012
through 2014 eRx Incentive Program,
and, while we appreciate the
commenters’ feedback, these comments
are outside the scope of the issues
addressed in this final rule with
comment period and are not included.
b. Eligibility
For the 2012 and 2013 incentive
payments and 2013 and 2014 payment
adjustments, we proposed the following
two ways eligible professionals may
participate in the eRx Incentive
Program: (1) as an individual eligible
professional; or (2) as part of a group
practice participating in the group
practice reporting option (GPRO) for the
eRx Incentive Program (eRx GPRO) (76
FR 42886). Professionals eligible to
participate in the eRx Incentive Program
are defined at 42 CFR 414.92(b) and
more information is available on the eRx
Incentive Program section of the CMS
Web site at: https://www.cms.gov/
ERxIncentive/05_Eligible%20
Professionals.asp#TopOfPage.
(1) Individual Eligible Professionals
(A) Definition of Eligible Professional
As in the 2011 eRx Incentive Program,
we proposed that, for individual eligible
professionals participating in the eRx
Incentive Program for purposes of the
2012 and 2013 incentive payments and
2013 and 2014 payment adjustments,
the determination of whether an eligible
professional is a successful electronic
prescriber will be made at the
individual professional level, based on
the National Provider Identifier (NPI)
number (76 FR 42886). As some
individuals (identified by NPIs) may be
associated with more than one practice
or Tax Identification Number (TIN), for
the 2012 and 2013 incentive payments
and 2013 and 2014 payment
adjustments, we proposed that the
determination of whether an eligible
professional is a successful electronic
prescriber will continue to be made for
each unique TIN/NPI combination.
Then, as in previous years, incentive
payments would then be made to the
applicable holder of the TIN. We
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proposed continuing to use the TIN/NPI
combination as the unit of analysis to
maintain program continuity, as
individual eligible professionals are
already familiar with this level of
analysis and payment. We invited
public comment on our proposal to
continue analyzing data using the TIN/
NPI combination while providing
payment to the applicable holder of the
TIN. We received no comments on our
proposal to continue analyzing data
using the TIN/NPI combination while
providing payment to the applicable
holder of the TIN and are therefore,
finalizing this proposal.
As in prior program years, we
proposed that individual eligible
professionals who wish to participate in
the eRx Incentive Program for purposes
of the 2012 and 2013 incentive
payments and 2013 and 2014 payment
adjustments may simply start
participating (76 FR 42886). Individual
eligible professionals are not required to
register or notify CMS they intend to
participate; rather, they may simply
begin to report the eRx measure. We
invited public comment on the
proposed process for individual eligible
professionals to participate in the eRx
Incentive Program. We received no
comments regarding our proposal, and
therefore, we are finalizing our proposal
that individual eligible professionals
who wish to participate in the eRx
Incentive Program for purposes of the
2012 and 2013 incentive payments and
2013 and 2014 payment adjustments
may simply start participating.
(2) Group Practices
As required under section
1848(m)(3)(C) of the Act, we established
a process under which eligible
professionals in a group practice (as
defined by the Secretary) would be
treated as having met the requirements
for submitting data on electronic
prescribing quality measures for covered
professional services for a reporting
period (or, for purposes of the payment
adjustment under section 1848(a)(5) of
the Act, for a reporting period for a year)
if, in lieu of reporting the electronic
prescribing measure, the group practice
reports measures determined
appropriate by the Secretary, such as
measures that target high-cost chronic
conditions and preventive care, in a
form and manner, and at a time
specified by the Secretary. Specifically,
we first established the eRx group
practice reporting option (eRx GPRO) in
2010, which was further modified in the
2011 PFS Final Rule (75 FR 73502). In
addition to determining whether an
eligible professional is a successful
electronic prescriber for incentive
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payment and payment adjustment
purposes based on separately analyzing
whether the individual eligible
professionals are successful electronic
prescribers, we proposed to also make
the determination that the group
practice, as a whole, is a successful
electronic prescriber in accordance with
section 1848(m)(3)(C) of the Act for
those group practices that wish to
participate in the eRx GPRO.
(A) Definition of ‘‘Group Practice’’
Section 1848(m)(3)(C)(i) of the Act
authorizes the Secretary to define
‘‘group practice,’’ which CMS defined
by referencing our regulation at § 414.90
(b). For the 2011 eRx Incentive Program,
under § 414.92(b), a group practice is—
(1) Defined at § 414.90(b), that is
participating in the Physician Quality
Reporting System; or
(2)(a) In a Medicare approved
demonstration project that is deemed to
be participating in the Physician Quality
Reporting System group practice
reporting option; and
(b) Has indicated its desire to
participate in the electronic prescribing
group practice option.
However, for purposes of determining
whether a group practice is a successful
electronic prescriber for CYs 2012
through 2014, we proposed to modify
the definition of the ‘‘group practice’’ at
42 CFR 414.92(b) to be consistent with
modifications we proposed for the
definition of ‘‘group practice’’ at 42 CFR
414.90(b) for the 2012 Physician Quality
Reporting System (76 FR 42886).
In particular, we proposed to modify
the definition of group practice under
the Physician Quality Reporting System
definition at 42 CFR 414.90(b) by
defining a group practice as a single TIN
with at least 25 or more eligible
professionals, as identified by their
individual NPI, who have reassigned
their Medicare billing rights to the TIN.
Given that the definition of ‘‘group
practice’’ at 42 CFR 414.92(b) follows
the Physician Quality Reporting System
definition, we proposed to apply the
modification to the definition for group
practice under the eRx Incentive
Program.
Although we noted this proposed
change would eliminate group practices
comprised of 2 to 24 eligible
professionals for the purpose of the eRx
GPRO, we believed changing the
definition of ‘‘group practice’’ would
not pose a significant burden to these
small group practices, because they
could still participate as individual
eligible professionals. For 2010, out of
107 group practices that self-nominated
to participate in GPRO II for the
Physician Quality Reporting System, 68
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of these group practices qualified to
participate in the eRx Incentive Program
under GPRO II. However, during the
opt-out period which ended on May 12,
2011, 6 of these 68 group practices
dropped out of GPRO II participation,
leaving only 62 group practices to
participate in GPRO II for 2010. Due to
the low participation of only 62 groups,
we believed that participation in the
eRx GPRO should be limited to only
those group practices with 25 or more
eligible professionals. We noted that
participating under GPRO II may be
more burdensome for very small group
practices than participating as eligible
professionals. For example, with respect
to the payment adjustment, additional
limitations may apply to eligible
professionals as individuals that are not
applied to group practices, which
present an additional burden to the
group practice.
We also proposed (76 FR 42866) to
modify the language that references
Medicare demonstrations to more
broadly recognize other similar
Medicare programs that group practices
may be participating in so that such
practices may be eligible to participate
in the eRx Incentive Program. We
received no comments related to our
proposal to more broadly recognize
Medicare programs other than the PQRS
GPRO where group practices may be
participating. Therefore, we are
finalizing this modification at 42 CFR
414.92(b). We are also modifying 42
CFR 414.92 to make clear that all group
practices must indicate their desire to
participate in the eRx GPRO.
We invited public comment on our
proposed definition of group practice
and below is a summary of the
comments we received and our
responses.
Comment: One commenter was
concerned with our proposal to change
the definition of group practice under
the eRx Incentive Program to groups
comprised of 25 or more eligible
professionals, consistent with our
proposal to change the definition of
group practice under the Physician
Quality Reporting System. The
commenter was concerned that this
definition change would preclude
smaller groups from participating in the
eRx GPRO.
Response: As we stated previously, in
2011, we allowed groups of 2–24
individual eligible professionals to
participate as a group practice under the
eRx GPRO II. Unfortunately, the turnout
for these smaller group practices
electing to participate under the eRx
GPRO II was low. Therefore, due to low
participation last year in the eRx GPRO
by groups comprised of 2–24 eligible
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professionals, we are finalizing our
proposal to use the definition of group
practice under the Physician Quality
Reporting System, which excludes
groups comprised of 2–24 eligible
professionals from participating in the
eRx GPRO. We note that these smaller
group practices may continue to report
the electronic prescribing measure for
purposes of the 2012 and 2013
incentives and 2013 and 2014 payment
adjustments as individual eligible
professionals.
Based on the comments received and
for the reasons stated above, we are
finalizing our proposed definition of
group practice at § 414.92(b) for
purposes of participating under the eRx
GPRO. However, we are making minor
technical changes to the clause numbers
under 42 CFR 414.92(b) to more
accurately reflect this changed
definition of group practice.
(B) Process To Participate in the eRx
Incentive Program—eRx GPRO
We proposed (76 FR 42881) that if a
group practice wishes to participate in
the eRx Incentive Program under the
eRx GPRO, the group practice must selfnominate to do so. To self-nominate, we
proposed that the group practice follow
the requirements for self-nomination
under the Physician Quality Reporting
System, as well as specifically indicate
its intent to participate in the eRx
Incentive Program as a group practice.
If a group practice self-nominates to
participate in the eRx GPRO for a
calendar year, then we proposed to
consider that the group practice is
participating in the eRx GPRO for
purposes of both the incentive payment
(with respect to any incentive payment
reporting period that occurs during the
calendar year) and the payment
adjustment (with respect to any
payment adjustment reporting period
that occurs during the calendar year).
For example, the 2013 payment
adjustment reporting period occurs
during calendar year 2012 (January 1,
2012 through June 30, 2012).
We invited public comment on the
requirements for eligible professionals
to participate as an eRx GPRO for
purposes of the eRx Incentive Program.
The following is a summary of the
comments we received regarding this
proposal.
Comment: Some commenters opposed
our proposal to require a group practice
wishing to participate as a group under
the eRx GPRO to also participate in the
Physician Quality Reporting System,
since some practitioners, such as
dermatologists, may not be able to
participate in the Physician Quality
Reporting System GPRO due to a lack of
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measures that are applicable to their
respective specialties.
Response: We appreciate the
commenters’ feedback. However, as in
prior years and for operational reasons,
we must require that all group practices
wishing to participate as a group under
the eRx GPRO also participate in the
Physician Quality Reporting System.
From an operational standpoint, group
practices participating in the eRx GPRO
must meet all the requirements of
participating as a group practice under
the Physician Quality Reporting System
GPRO to ensure that the group practice
is fully aware of requirements for
participating as a group practice under
the eRx GPRO. All GPRO educational
sessions we hold focus on reporting
under the GPRO for purposes of both
programs. Furthermore, it is easier to
keep track of which group practices are
participating under the GPRO option for
both the Physician Quality Reporting
System and the eRx Incentive Program
by requiring that group practices
participating in the eRx GPRO also
participate in the Physician Quality
Reporting System GPRO. Please note,
however, that this is not a requirement
that group practices meet the
requirements for satisfactory reporting
under the Physician Quality Reporting
System in order to participate in the eRx
GPRO. We also note this does not
preclude individuals within group
practices from participating in the eRx
Incentive Program as individuals.
Comment: We received one comment
on the self-nomination process. The
commenter felt the process is overly
burdensome.
Response: In determining what
should be included in the selfnomination process, we attempted to
balance what we believed was necessary
to determine a group practice’s intent to
participate in the eRx GPRO versus the
burden to the group practice. For
example, we believe it is necessary to
require group practices to indicate their
intent to participate in the eRx Incentive
Program under the eRx GPRO in writing
to keep track of who is participating
under the eRx Incentive Program under
the eRx GPRO so the eligible
professionals associated under the
respective group practice may be
analyzed at the group level. We believe
that the requirement to submit a selfnomination statement is not an unduly
burdensome task for a group practice.
With respect to the additional
requirements we are finalizing, such as
requiring that group practices wishing
to participate in the eRx Incentive
Program under the eRx GPRO attend
scheduled training sessions, we believe
that these requirements provide group
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practices with needed guidance on how
to meet the requirements for becoming
a successful electronic prescribers as
group practices. This added guidance,
in our opinion, will lead to a greater
probability that group practices
participating under the eRx GPRO will
qualify to earn the 2012 and 2013
incentives as well as fulfill criteria for
the 2013 and 2014 payment
adjustments.
After considering the comments
received and for the reasons stated in
our responses, we are finalizing our
proposal that, in order for a group
practice to participate as a group under
the eRx GPRO, the group practice must
self-nominate for each calendar year the
group wishes to participate in the eRx
GPRO. If a group practice self-nominates
to participate in the eRx GPRO for a
calendar year, then we will consider
that the group practice to be
participating in the eRx GPRO as a
group practice for purposes of both the
incentive payment and the payment
adjustment. Therefore, if an eligible
professional is part of a group practice
participating in the eRx GPRO for a
respective program year, the eligible
professional in the group practice is
precluded from participating as an
individual eligible e professional for
purposes of both the 2012 and 2013
incentives and 2013 and 2014 payment
adjustments. For example, the 2013
payment adjustment reporting period
occurs during calendar year 2012
(January 1, 2012 through June 30, 2012).
Therefore, any group practice
participating in the eRx GPRO during
calendar year 2012 would be considered
to be participating in the eRx GPRO for
both the 2012 incentive and 2013
payment adjustment.
Also, as we clarified in the proposed
rule (76 FR 42887), a group practice that
is deemed to be participating in the
Physician Quality Reporting System,
such as an ACO participating under the
Medicare Shared Savings Program, will
not be deemed participating as a group
practice in the eRx Incentive Program.
To participate in the eRx Incentive
Program under the eRx GPRO, such
group practices must self-nominate to
do so. Instructions for submitting the
self-nomination statement are the same
as the instructions for submitting a selfnomination statement for the Physician
Quality Reporting System. Each year,
we expect to notify a group practice of
the selection decision with respect to
participation in the eRx GPRO during
the first quarter of the year.
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c. Reporting Periods
(1) Reporting Periods for the 2012 and
2013 eRx Incentives
Section 1848(m)(6)(C)(i)(II) of the Act
defines ‘‘reporting period’’ under the
eRx Incentive Program for years after
2008 to be the entire year. We also have
authority under section
1848(m)(6)(C)(ii) of the Act to revise the
reporting period if the Secretary
determines such revision is appropriate,
produces valid results on measures
reported, and is consistent with the
goals of maximizing scientific validity
and reducing administrative burden. We
proposed (76 FR 42887), the entire
calendar year as the reporting period for
purposes of the 2012 and 2013 incentive
payment (January 1, 2012 through
December 31, 2012 for the 2012
incentive and January 1, 2013 through
December 31, 2013 for the 2013
incentive, respectively). Accordingly,
we proposed to modify 42 CFR
414.92(d)(1).
We invited public comment on the
proposed reporting periods for the 2012
and 2013 incentives. The following is a
summary of the comment we received
regarding these proposals.
Comment: One commenter supported
our proposals to base the 2012 and 2013
incentives off of 12-month reporting
periods.
Response: We appreciate the
commenter’s feedback and are finalizing
our proposed reporting periods for the
2012 and 2013 incentives.
Based on the comment received and
for the reasons stated above, we are
finalizing the reporting period for the
2012 incentive as the 12-month period
of January 1, 2012 through December 31,
2012, and reporting period for the 2013
incentive as the 12-month period of
January 1, 2013 through December 31,
2013, and finalizing the changes to the
regulation at § 414.92(d)(1).
(2) Reporting Periods for the 2013 and
2014 eRx Payment Adjustments
Under our authority under section
1848(m)(6)(C)(ii) of the Act, in the 2011
PFS final rule with comment period, we
finalized two different reporting
periods: A 6-month reporting period
(between January 1, 2011 and June 30,
2011) for purposes of the 2012 payment
adjustment for both individual eligible
professionals and group practices
participating in the eRx GPRO (75 FR
73562 through 73563) and a 12-month
reporting period (between January 1,
2011 and December 31, 2011) for
purposes of the 2013 payment
adjustment for individual eligible
professionals and group practices
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participating in the eRx GPRO (75 FR
73565).
In addition to the 12-month reporting
period finalized in the 2011 PFS final
rule with comment period, in the
proposed rule we proposed (76 FR
32887), for both individual eligible
professionals and group practices
participating in the eRx GPRO, an
additional 6-month reporting period
(between January 1, 2012 and June 30,
2012) for purposes of the 2013 payment
adjustment.
For similar reasons, for the 2014
payment adjustment, we proposed a 12month reporting period (between
January 1, 2012 and December 31, 2
012) that would apply to individual
eligible professionals and a 6-month
reporting period (between January 1,
2013 and June 30, 2013) that would
apply to both individual eligible
professionals and group practices, so
that two different reporting periods
would provide eligible professionals
with two opportunities to be successful
electronic prescribers.
We invited public comment on the
proposed reporting periods for the 2013
and 2014 payment adjustments. The
following is a summary of the comments
we received regarding these proposals.
Comment: Several commenters
supported our proposed reporting
periods for the 2013 and 2014 payment
adjustment, including our proposal to
provide multiple reporting periods. A
few commenters opposed, however, our
proposal to provide multiple reporting
periods for the 2013 and 2014 payment
adjustments, stating that having
multiple reporting periods leads to
greater program complexity. Rather, a
few commenters suggested that we
should use a single, 12-month reporting
period that would provide us with 12
months of data.
Response: We appreciate the
commenter’s feedback. However, we
believe that, in this instance, our
interest in providing eligible
professionals and group practices with
additional opportunities to become
successful electronic prescribers
outweighs our interest in streamlining
the program and collecting 12 months of
data. Furthermore, we note that eligible
professionals are not required to qualify
for the 2013 and 2014 payment
adjustments under multiple reporting
periods. Eligible professionals may
choose under which respective
reporting period the eligible
professionals plan to satisfy the
requirements for the 2013 and 2014
payment adjustments. We note that the
main purpose of having eligible
professionals report on the electronic
prescribing measure is to ensure
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electronic prescribing systems are being
utilized, not to collect data. Therefore,
we are finalizing the proposed reporting
periods for the 2013 and 2014 payment
adjustments.
Comment: Several commenters were
opposed to our proposed reporting
periods for the 2013 and 2014 payment
adjustments and suggested that we
instead finalize reporting periods for the
2013 and 2014 payment adjustments
that occur later in time. For example,
some commenters believed that the
2013 and 2014 payment adjustments
should be based on data reported in
2013 and 2014, respectively. Another
commenter suggested a 9-month
reporting period (that is, January 1, 2012
through September 1, 2012) for the 2013
payment adjustment.
Response: We appreciate the
commenters’ feedback. However, as we
stated in the 2011 PFS Final Rule (75 FR
73562), under section 1848(a)(5)(D) of
the Act, we have the discretion to define
the ’’reporting period’’ for purposes of
the payment adjustment with respect to
a year. We interpreted the payment
adjustment provision under section
1848(a)(5) of the Act as having the 2012
payment adjustment applied to reduce
the PFS amount concurrently with
claims submissions in 2012.
Accordingly, we believe that it is
necessary to apply the 2013 and 2014
payment adjustment concurrently with
claim submissions in 2013 and 2014,
respectively.
With respect to the suggested 9-month
reporting period, for operational
reasons, we cannot finalize a reporting
period that ends later than June 30, 2012
for the 2013 payment adjustment and
June 30, 2013 for the 2014 payment
adjustment. The process required to
perform a full analysis of eligible
professionals’ claims data can take more
than five months to complete. This is
due to numerous factors, including the
allowance of a one month run-out for
claims processing (for example, through
July 29, 2012, for claims with dates of
service of January 1, 2012, through June
30, 2012). Additionally, the time
required to perform the data analyses to
determine non-successful electronic
prescribers, and to update the systems
to make the appropriate reductions to
Physician Fee Schedule payments for
claims submitted on or after January 1,
2012 and January 1, 2013 respectively
can take up to four months to complete.
Taking into account these operational
issues, we believe that finalizing a
reporting period ending on June 30,
2012 and June 30, 2013 for the 2013 and
2014 respective payment adjustments
will allow us to avoid having to recoup
overpayments.
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After considering the comments
received and for the reasons explained
in our responses, we are finalizing the
6-month reporting periods for the 2013
and 2014 payment adjustments.
Specifically, in addition to the 12month reporting period finalized in the
2011 PFS final rule with comment
period, we are finalizing an additional
6-month reporting period (that is,
January 1, 2012 through June 30, 2012)
for purposes of the 2013 payment
adjustment. For the 2014 payment
adjustment, we are finalizing a 6-month
reporting period (between January 1,
2013 and June 30, 2013) for both
individual eligible professionals and
group practices participating in the eRx
GPRO. We also are finalizing a 12month reporting period (between
January 1, 2012 and December 31, 2012)
for individual eligible professionals for
the 2014 payment adjustment. As for
group practices, we note that there was
some ambiguity in the proposed rule (76
FR 42985), with regard to a 12-month
reporting period for group practices
participating in the eRx GPRO for the
2014 payment adjustment. Although we
proposed criteria for being a successful
electronic prescriber for group practices
reporting from January 1, 2012 through
December 31, 2012, for the 2014
payment adjustment (76 FR 42985
through 42986), we only proposed that
the 12-month reporting period for the
2014 payment adjustment (that is,
January 1, 2012 through December 31,
2012) would apply to individual eligible
professionals (76 FR 42887).
Additionally, at 42 CFR 414.92(f)(1), we
proposed regulatory changes that would
provide for this 12-month reporting
period (76 FR 42946). Since, as
discussed in section VI.F.1.e.(6). of this
final rule with comment period, we are
finalizing the proposed criteria for being
a successful electronic prescriber
pertaining to a 12-month period for
group practices for purposes of the 2014
payment adjustment, we are also
finalizing the 12-month reporting period
(that is, January 1, 2012 through
December 31, 2012) for group practices
participating under the eRx GPRO for
the 2014 payment adjustment. We
believe this will afford group practices
additional options for reporting for
purposes of the 2014 payment
adjustment.
Therefore, we are finalizing the
proposed changes to the regulation at 42
CFR 414.92(f)(1).
d. Standard for Determining Successful
Electronic Prescribers
Section 1848(m)(3)(B) of the Act
governs the requirements for being a
‘‘successful electronic prescriber,’’ for
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purposes of the incentive payment
under section 1848(m)(2) of the Act and
the payment adjustment under section
1848(a)(5) of the Act. The Secretary is
authorized to use one of two possible
criteria for determining whether an
eligible professional is a successful
electronic prescriber. One criterion,
under section 1848(m)(3)(B)(ii) of the
Act, is based on the eligible
professional’s reporting, in at least 50
percent of the reportable cases, on any
electronic prescribing quality measures
that have been established under the
Physician Quality Reporting System,
and are applicable to services furnished
by the eligible professional for the
reporting period. However, for years
after 2009, section 1848(m)(3)(D) of the
Act permits the Secretary in
consultation with stakeholders and
experts to revise the criteria for
submitting data on electronic
prescribing quality measures under
section 1848(m)(3)(B)(ii) of the Act.
The second criterion, under section
1848(m)(3)(B)(iii) of the Act, is based on
the electronic submission by the eligible
professional of a sufficient number (as
determined by the Secretary) of
prescriptions under Part D during the
reporting period. If the Secretary
decides to use this standard, then, in
accordance with section
1848(m)(3)(B)(iv) of the Act, the
Secretary is authorized to use Part D
data to assess whether a sufficient
number of prescriptions have been
submitted by eligible professionals.
However, under section 1848(m)(3)(B)(i)
of the Act, if the Secretary decides the
standard based on a sufficient number
of electronic Part D prescriptions
applies for a particular reporting period,
then the standard based on the reporting
on electronic prescribing quality
measures does not apply.
We considered use of the second
criterion for determining successful
prescribing under the eRx Incentive
Program. While we recognize the
benefits of using Part D data as the
standard for determining successful
electronic prescribers, we believe use of
Part D prescriptions for analysis may be
premature. For example, there is
uncertainty as to the accuracies of
reporting electronic prescribing
activities using Part D data. For
example, if an electronic prescription is
converted to a facsimile when reaching
the pharmacy on Part D data, the
transmission is still reported as a pure,
electronic prescribing event.
Furthermore, use of Part D data would
require a complete overhaul of the
current requirements for the eRx
Incentive Program. For instance, if we
choose to shift to the use of Part D data,
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the program would have to adopt a new
form of measurement, a new form of
analysis other than use of an eligible
professionals’ TIN/NPI (TIN data is not
available in Part D data sets), and new
criteria for eligible professionals and
eRx GPROs to become successful
electronic prescribers. Therefore, we did
not propose to use the second criterion.
For the reasons stated previously, we
proposed (76 FR 42888) to continue to
require eligible professionals to report
on the electronic prescribing quality
measure used in 2011 to determine
whether an eligible professional is a
successful electronic prescriber for the
remainder of the eRx Incentive Program.
We proposed, however, to modify the
electronic prescribing quality measure’s
specifications and use modified
reporting criteria based on the authority
provided under section 1848(m)(3)(D) of
the Act (76 FR 42888). We invited
public comment on the continued use of
reporting the electronic prescribing
quality measure for purposes of the
‘‘successful electronic prescriber’’
determination under the program. We
received no comments regarding our
proposal to continue use of the
electronic prescribing quality measure
standard and therefore, we are finalizing
our proposal to use the electronic
prescribing quality measure standard for
purposes of determining whether an
eligible professional is a successful
electronic prescriber. Our proposals and
final decisions with regard to the
criteria for being a successful electronic
prescriber under this standard for the
2012 and 2013 eRx Incentives and the
2013 and 2014 eRx payment
adjustments are discussed in the
following sections VI.F.2.g.(2).,
VI.F.2.g.(3)., and VI.F.2.h.(2). of this
final rule with comment period.
(1) Reporting the Electronic Prescribing
Quality Measure
The electronic prescribing quality
measure, similar to the Physician
Quality Reporting System measures, has
two basic elements, which include: (1)
A denominator that defines the patient
population on which the eligible
professional’s performance is being
measured; and (2) a reporting
numerator, which identifies whether or
not a clinical quality action was
performed. The final details of the
electronic prescribing measure specified
later in this section apply to the
following eRx Incentive Program years:
The 2012 eRx incentive payment; the
2013 eRx incentive payment; the 2013
eRx payment adjustment; and the 2014
eRx payment adjustment.
Under section 1848(k)(2)(C)(i) of the
Act, the electronic prescribing quality
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measure, which was initially introduced
under the Physician Quality Reporting
System, shall be a measure selected by
the Secretary that has been endorsed by
the entity with a contract with the
Secretary under section 1890(a) of the
Act. Currently, that entity is the
National Quality Forum (NQF). The
electronic prescribing measure we
proposed to retain, NQF Measure #0486:
Adoption of Medication e-Prescribing,
was endorsed by the NQF in 2011.
However, pursuant to the changes
finalized in the 2011 ‘‘Changes to the
Electronic Prescribing (eRx) Incentive
Program’’ final rule, we modified the
description statement of the NQFendorsed electronic prescribing measure
to allow for use of Certified EHR
Technology to report the electronic
prescribing quality measure (76 FR
54954–54956). This modification has
not yet been reviewed by the NQF. In
light of this, we are not aware of any
other NQF-endorsed measure related to
electronic prescribing by eligible
professionals that would be appropriate
for use in the eRx Incentive Program.
Therefore, we believe that the use of this
eRx measure falls within the exception
under section 1848(k)(2)(C)(ii) of the
Act.
(2) The Denominator for the Electronic
Prescribing Measure
The denominator for the electronic
prescribing quality measure consists of
specific billing codes for covered
professional services.
As initially authorized under section
1848(k)(2)(A)(ii) of the Act, and further
established through rulemaking and
under section 1848(m)(2)(B)(i) of the
Act, we may modify the codes making
up the denominator of the electronic
prescribing measure. For 2011, we
expanded the scope of the denominator
codes for 2010 to covered professional
services outside the professional office
and outpatient setting, such as
professional services furnished in
skilled nursing facilities or the home
care setting (75 FR 73555). For purposes
of reporting periods during CYs 2012
and 2013 (for the 2012 and 2013
incentives and the 2013 and 2014
payment adjustments), we proposed
(76 FR 42888) to retain these CPT and
HCPCS codes in the denominator of the
electronic prescribing measure, because
we believe that these codes represent
the types of services for which
prescriptions are likely to be generated.
Therefore, if we were to measure an
eligible professional’s performance on
the electronic prescribing measure, we
would want to do so only for patients
who saw the professional for such
services. Although in prior years we
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only permitted eligible professionals to
report the electronic prescribing
measure’s numerator in connection with
a service in the measure’s denominator,
and proposed to continue this
requirement for purposes of the 2012
and 2013 incentives, in contrast, for the
2013 and 2014 payment adjustments,
we proposed to depart from this
requirement, as discussed in section
VI.F.2.i. of this final rule with comment
period.
We invited public and only received
the following comment on our proposal
to retain the denominator codes
contained in the 2011 electronic
prescribing measure:
Comment: One commenter requested
that codes 90804, 90806, 96151, and
96152, which reflect psychotherapy
services, be removed from the
denominator of the electronic
prescribing measure, because the
commenter believed prescriptions
should not be generated for these types
of services.
Response: We appreciate the
commenter’s feedback, but we disagree.
We believe these codes represent the
types of services for which prescriptions
may be generated and therefore, are
appropriate to include in the
denominator of the electronic
prescribing measure. We point out,
however, that by finalizing these
denominator codes, we are not
attempting to promote or discourage the
generation of prescriptions for these
psychotherapy services.
Based on the comment received and
for the reasons explained in our
responses, we are finalizing our
proposal to retain the denominator
codes contained in the 2011 electronic
prescribing measure. Specifically, we
are finalizing for the 2012 and 2013 eRx
program years the following
denominator CPT and HCPCS codes in
the denominator of the electronic
prescribing measure: 90801, 90802,
90804, 90805, 90806, 90807, 90808,
90809, 90862, 92002, 92004, 92012,
92014, 96150, 96151, 96152, 99201,
99202, 99203, 99204, 99205, 99211,
99212, 99213, 99214, 99215, 99304,
99305, 99306, 99307, 99308, 99309,
99310, 99315, 99316, 99324, 99325,
99326, 99327, 99328, 99334, 99335,
99336, 99337, 99341, 99342, 99343,
99344, 99345, 99347, 99348, 99349,
99350, G0101, G0108, and G0109
(75 FR 73555).
(3) The Reporting Numerator for the
Electronic Prescribing Measure
Currently, the electronic prescribing
measure’s numerator consists of a single
code, G8553, which indicates that the
prescription was generated and
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transmitted via a qualified electronic
prescribing system (and below, we
discuss in greater detail what
constitutes a ‘‘qualified system’’). For
purposes of reporting the electronic
prescribing quality measure for the 2012
and 2013 incentives and the 2013 and
2014 payment adjustment, we proposed
(76 FR 42888–42889) that an eligible
professional or group practice
participating in the eRx GPRO can
report the code associated with the
measure’s numerator whenever a
prescription is generated and
transmitted electronically. We invited
public comment on the proposed
numerator for the electronic prescribing
measure for CYs 2012 through 2013 eRx
Incentive Program, but, we did not
receive any comments related to the
proposed electronic prescribing
measure’s numerator G-code for CYs
2012 and 2013. Therefore, for CYs 2012
and 2013 of the eRx Incentive Program,
we are finalizing G–8553 for electronic
prescribing measure’s numerator.
We intend to post the final electronic
prescribing measure specifications on
the ‘‘eRx Measure’’ page of the eRx
Incentive Program section of the CMS
Web site at https://www.cms.gov/
ERXIncentive by no later than—
• December 31, 2011 for the reporting
periods that occur during calendar year
2012.
• December 31, 2012 for the reporting
periods that occur during calendar year
2013.
In the event that additional changes
are needed to the measure specifications
for years after 2012, we will do so via
notice and comment rulemaking prior to
posting the final measure specifications
for that year.
e. Required Functionalities and Part D
Electronic Prescribing Standards
As discussed in greater detail below,
for purposes of the 2012 and 2013
incentive and 2013 and 2014 payment
adjustment, we proposed (76 FR 42889)
that when the eligible professional or
group practice reports the measure’s
numerator G-code, the eligible
professional or group practice must
have and regularly use a ‘‘qualified’’
electronic prescribing system, which we
further proposed to define as either a
system with the four functionalities
previously identified in the electronic
prescribing measure specifications, or
Certified EHR Technology, as defined at
42 CFR 495.4 and 45 CFR 170.102. We
also made proposals with regard to the
Part D electronic prescribing standards
for the electronic prescribing measures.
Our proposed technological
requirements of the electronic
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prescribing quality measure are
discussed below.
(1) ‘‘Qualified’’ Electronic Prescribing
System
We are aware that there are significant
numbers of eligible professionals who
are interested in participating in the eRx
Incentive Program but currently do not
have an electronic prescribing system or
Certified EHR Technology. Generally,
the electronic prescribing measure does
not require the use of any particular
system or transmission network; only
that the system be a ‘‘qualified’’ system.
If the professional does not have general
access to an electronic prescribing
system or Certified EHR Technology in
the practice setting, the eligible
professional will not be able to report
the electronic prescribing measure. In
addition to not being eligible for an
incentive payment, an eligible
professional who does not report the
electronic prescribing measure for 2012
or 2013 will be subject to the 2013 or
2014 eRx payment adjustment, unless
an exception applies.
We proposed (76 FR 4289) to continue
to recognize as a ‘‘qualified’’ electronic
prescribing system for purposes of the
electronic prescribing quality measure
any system that can perform the four
functionalities that were identified and
required under the program in 2010 and
2011 (76 FR 42889). We invited public
comment on our proposal that the
definition of a ‘‘qualified electronic
prescribing system,’’ include systems
that have these four functionalities. We
did not receive any comments regarding
our proposal to retain the same
functionalities. Therefore, for years 2012
through 2014 of the eRx Incentive
Program, we are finalizing our decision
to recognize as a ‘‘qualified’’ electronic
prescribing system, a system that can do
the following:
• Generate a complete active
medication list incorporating electronic
data received from applicable
pharmacies and PBMs, if available.
• Enable eligible professionals to
select medications, print prescriptions,
electronically transmit prescriptions, as
well as provide notifications (that is,
signals to warn the prescriber of
possible undesirable or unsafe
situations including potentially
inappropriate dose or route of
administration of a drug, drug-drug
interactions, allergy concerns, or
warnings and cautions). This
functionality must be enabled.
• Provide information related to
lower cost, therapeutically appropriate
alternatives (if any). The ability of an
electronic prescribing system to receive
tiered formulary information, if
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available, would again suffice for this
requirement for reporting the electronic
prescribing measure during the
reporting periods occurring in CYs 2012
and 2013 until this function is more
widely available in the marketplace.
• Provide information on formulary
or tiered formulary medications, patient
eligibility, and authorization
requirements received electronically
from the patient’s drug plan (if
available).
For reporting periods that occur in
CYs 2012 and 2013, we also proposed
to expand the definition of a ‘‘qualified’’
electronic prescribing system to include
Certified EHR Technology, as defined at
42 CFR 495.4 and 45 CFR 170.102,
because we believe the technological
requirements for electronic prescribing
under the EHR Incentive Program are
similar to the technological
requirements for the eRx Incentive
Program. We believe expanding the
definition of a ‘‘qualified’’ electronic
prescribing system in this way will align
the requirements of the eRx and the
Medicare EHR Incentive Program and
potentially reduce unnecessary
investment in multiple technologies for
purposes of meeting the requirements
for each program. This proposal was
consistent with changes we finalized for
certain reporting periods in CY 2011 for
the 2011 eRx incentive and the 2013
eRx payment adjustment in the
September 6, 2011 final rule entitled
‘‘Medicare Program; Changes to the
Electronic Prescribing (eRx) Incentive
Program’’ (76 FR 54953, 54956).
We invited public comment on the
proposed requirements of a ‘‘qualified’’
electronic prescribing system for
purposes of reporting the electronic
prescribing measure. The following is a
summary of the comments we received
regarding these proposals.
Comment: Several commenters
supported our proposal to retain our
modification of the electronic
prescribing measure to allow for use of
Certified EHR Technology. Commenters
supported our efforts to align the eRx
Incentive Program and EHR Incentive
Program in this manner. Commenters
also believed that allowing for use of
Certified EHR Technology reduces
burden on eligible professionals.
Response: We appreciate the
commenters’ supportive feedback and
are finalizing our proposal to expand
the definition of a ‘‘qualified’’ electronic
prescribing system to include Certified
EHR Technology for the reasons we and
commenters noted.
Therefore, in summary, for reporting
periods that occur during CYs 2012 and
2013 of the eRx Incentive Program, we
are finalizing our proposal that a
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‘‘qualified’’ electronic prescribing
system for the electronic prescribing
quality measure is one that either meets
the four functionalities noted, or is
Certified EHR Technology, as defined at
42 CFR 495.4 and 45 CFR 170.102
(regardless of whether the Certified EHR
Technology has all four functionalities
noted).
(2) Part D Electronic Prescribing
Standards
Section 1848(m)(3)(B)(v) of the Act
specifies that to the extent practicable,
in determining whether an eligible
professional is a successful electronic
prescriber, ‘‘the Secretary shall ensure
that eligible professionals utilize
electronic prescribing systems in
compliance with standards established
for such systems pursuant to the Part D
Electronic Prescribing Program under
section 1860D–4(e) of the Act’’. The Part
D standards for electronic prescribing
systems establish which electronic
standards Part D sponsors, providers,
and dispensers must use when they
electronically transmit prescriptions
and certain prescription related
information for Part D covered drugs
that are prescribed for Part D eligible
individuals.
To be a qualified electronic
prescribing system under the eRx
Incentive Program, electronic systems
must convey the information listed
previously using the standards currently
in effect for the Part D electronic
prescribing program. The latest Part D
electronic prescribing standards, and
those that had previously been adopted,
can be found on the CMS Web site at
https://www.cms.gov/eprescribing.
To ensure that eligible professionals
utilize electronic prescribing systems
that meet these requirements, the
electronic prescribing measure requires
that those functionalities required for a
‘‘qualified’’ electronic prescribing
system are equivalent to the adopted
Part D electronic prescribing standards.
We proposed (76 FR 42889 and 42890)
to modify the Part D electronic
prescribing standards required for a
‘‘qualified’’ electronic prescribing
system under the eRx Incentive Program
to have these standards consistent with
current, CMS Part D electronic
prescribing standards.
The Part D electronic prescribing
standards currently in place that are
relevant to the four functionalities
described previously are as follows:
• Generate medication list—Use the
National Council for Prescription Drug
Programs (NCPDP) Prescriber/
Pharmacist Interface SCRIPT Standard,
Implementation Guide, Version 8
Release 1 or 10.6, October 2005
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(hereinafter ‘‘NCPDP SCRIPT 8.1 or
10.6’’) Medication History Standard.
Use of NCPDP SCRIPT 10.6 is a new
option for use in the eRx Incentive
Program.
• Transmit prescriptions
electronically—Use the NCPDP SCRIPT
8.1or 10.6 for the transactions listed at
§ 423.160(b)(2).
• Provide information on lower cost
alternatives—Use the NCPDP Formulary
and Benefits Standard, Implementation
Guide, Version 1, Release 0 (Version
1.0), October 2005 (hereinafter ‘‘NCPDP
Formulary and Benefits 1.0’’).
• Provide information on formulary
or tiered formulary medications, patient
eligibility, and authorization
requirements received electronically
from the patient’s drug plan use:
++ NCPDP Formulary and Benefits
1.0 for communicating formulary and
benefits information between
prescribers and plans.
++ Accredited Standards Committee
(ASC) X12N 270/271-Health Care
Eligibility Benefit Inquiry and Response,
Version 4010, May 2000, Washington
Publishing Company, 004010X092 and
Addenda to Health Care Eligibility
Benefit Inquiry and Response, Version
4010A1, October 2002, Washington
Publishing Company, 004010X092A1
for communicating eligibility
information between the plan and
prescribers.
++ NCPDP Telecommunication
Standard Specification, Version 5,
Release 1 (Version 5.1), September 1999,
and equivalent NCPDP Batch Standard
Batch Implementation Guide, Version 1,
Release 1 (Version 1.1), January 2000 for
communicating eligibility information
between the plan and dispensers.
We did not receive any comments
regarding our proposals related to part
D electronic prescribing standards and
therefore, we are finalizing our proposal
that, for purposes of the 2012 and 2013
eRx Incentive Program, ‘‘qualified’’
electronic prescribing systems must
meet all of the part D electronic
prescribing standards specified.
Above, we specified the current Part
D electronic prescribing standards that
are relevant to the four functionalities.
Should these Part D electronic
prescribing standards subsequently
change, we note that the eligible
professional’s electronic prescribing
system must, at all times during the
respective reporting period, comply
with the current Part D electronic
prescribing standards. For example, on
October 24, 2011, CMS proposed to
update some of the previously stated
Part D electronic prescribing standards
to the four functionalities (76 FR 65916).
Specifically, CMS proposed to update
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Accredited Standards Committee (ASC)
X12N 270/271–Health Care Eligibility
Benefit Inquiry and Response, Version
4010 to Version 5010. If CMS finalizes
its proposal, an eligible professional’s
electronic prescribing system must
comply with the Version 5010 update
by the effective date that would be
specified in the final rule.
There are Part D electronic
prescribing standards that are in effect
for functionalities that are not
commonly utilized at this time. One
example is Rx Fill Notification, which is
discussed in the Part D electronic
prescribing final rule (73 FR 18926). For
purposes of the eRx Incentive Program
for CYs 2012 through 2014, we again are
not requiring that an electronic
prescribing system contain all
functionalities for which there are
available Part D electronic prescribing
standards since many of these
functionalities are not commonly
available. For those ‘‘qualified’’
electronic prescribing systems that have
the four functionalities previously
described, such systems must use the
adopted Part D electronic prescribing
standards listed previously for
electronic messaging only.
There are other aspects of the
functionalities for a ‘‘qualified’’ system
that are not dependent on electronic
messaging and are part of the software
of the electronic prescribing system, for
which Part D standards for electronic
prescribing do not pertain and are not
required for purposes of the eRx
Incentive Program. For example, the
requirements in the second
functionality that require the system to
allow professionals to select
medications, print prescriptions, and
conduct alerts are functions included in
the particular software, for which Part D
standards for electronic messaging do
not apply.
As stated previously, in this final rule
with comment period, we are finalizing
our proposal to expand the definition of
a ‘‘qualified’’ electronic prescribing
system under the electronic prescribing
quality measure to also recognize
Certified EHR Technology. Among other
requirements, Certified EHR Technology
must be able to electronically generate
and transmit prescriptions and
prescription-related information in
accordance with certain standards, some
of which have been adopted for
purposes of electronic prescribing under
Part D. Similar to the electronic
prescribing systems that have the four
functionalities previously noted,
Certified EHR Technology also must be
able to check for drug-drug interactions
and check whether drugs are in a
formulary or a preferred drug list,
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although the certification criteria do not
specify any standards for the
performance of those functions. We
believe that it is acceptable that not all
of the Part D eRx standards are required
for Certified EHR Technology in light of
our desire to better align the
requirements of the eRx and the
Medicare EHR Incentive Programs, and
potentially reduce unnecessary
investment in multiple technologies for
purposes of meeting the requirements
for each program. Furthermore, to the
extent that an eligible professional uses
Certified EHR Technology to
electronically prescribe under Part D, he
or she would still be required to comply
with the applicable Part D standards to
do so.
f. Reporting Mechanisms for the 2012
and 2013 Reporting Periods
For purposes of the January 1, 2011
through December 31, 2011 reporting
period for the 2011 incentive payment
and 2013 payment adjustment, an
eligible professional (and eRx GPRO, for
purposes of the 2011 incentive) may
report on the electronic prescribing
measure to meet the criteria for being a
successful electronic prescriber via
three reporting mechanisms—claims,
qualified registry, and qualified EHR
product. However, for purposes of the
2012 payment adjustment, due to
operational limitations, only the claimsbased reporting mechanism was
available for purposes of reporting on
the electronic prescribing measure for
the 2012 payment adjustment (75 FR
73563).
For reporting periods that occur
during CY 2012 and 2013, to provide
eligible professionals and groups
practices with multiple mechanisms to
report on the electronic prescribing
measure for purposes of reporting the
electronic prescribing measure for the
2012 and 2013 incentive payments and
2013 and 2014 payment adjustments,
we proposed (76 FR 42890) the
following three reporting mechanisms—
claims, qualified registry, and qualified
EHR (including both direct EHR-based
reporting and EHR data submission
vendors). However, as in the past, we
indicated we would not combine data
on the electronic prescribing measure
submitted via multiple reporting
mechanisms. Combining data received
via multiple reporting mechanisms
would add significant complexity to our
analytics and potentially delay
incentive payments. Therefore, we
proposed that an eligible professional or
eRx GPRO would need to meet the
relevant reporting criteria for the
incentive or payment adjustment using
a single reporting mechanism.
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For reporting periods that occur
during CYs 2012 and 2013, we also
proposed that a group practice that
wishes to participate in the eRx
Incentive Program as an eRx GPRO for
a particular calendar year would have to
indicate which reporting mechanism the
group practice intends to use to report
the electronic prescribing measure. That
is, the group practice would need to
indicate at the time it self-nominates
which reporting mechanism (claims,
qualified registry, qualified direct EHRbased reporting, or qualified EHR data
submission vendor) the group practice
intends to use for purposes of
participating in the eRx GPRO.
The following is a summary of the
comments we received regarding these
proposals.
Comment: One commenter supported
our proposal to allow multiple reporting
mechanisms to report the electronic
prescribing measure for purposes of the
payment adjustment, particularly for
those group practices that are
transitioning to the use of EHR systems.
Response: We appreciate the
commenter’s feedback. We are finalizing
the claims, registry, and EHR-based
reporting mechanisms for the12-month
reporting periods that apply to the 2012
and 2013 incentives and 2014 payment
adjustment. However, because the EHR
and/or registry would no longer need to
search for the codes in the electronic
prescribing measure’s denominator for
purposes of the 6-month reporting
periods that apply to the 2013 and 2014
payment adjustments, CMS would need
to be able to release new file
specifications to reflect this change in
time to reliably test the submission of
the results from EHRs and registries
prior to the actual data submission
occurring in July. We will not be able
to release the new file specifications in
time to conduct this additional testing,
which raises the chances of an eligible
professional failing to successfully
report through no fault of their own.
Therefore, we are not finalizing the
registry and EHR-based reporting
mechanisms for the 6-month reporting
periods pertaining to the 2013 and 2014
payment adjustments. In addition, we
note that if we had allowed use of
registry and EHR-based reporting for the
6-month reporting periods for the 2013
and 2014 payment adjustments, this
would require registry and EHR vendors
to submit electronic prescribing data for
an additional instance during 2012 and
2013 (that is, in addition to the data
submission for the 12-month reporting
period). Since providing an additional
submission instance of electronic
prescribing data has not been a function
of qualified registries and EHRs in past
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program years, CMS would need to vet
vendors to ensure their systems allow
for interim submissions. At this time, it
is not operationally feasible to vet these
vendors to ensure their systems allow
for a submission instance.
We do not believe that the lack of
registry and EHR-based reporting
mechanisms for the 6-month reporting
periods for the 2013 and 2014 payment
adjustments would substantially
prevent eligible professionals and group
practices from meeting the criteria for
being successful electronic prescribers,
because eligible professionals may still
report on the electronic prescribing
measure during these reporting periods
via claims and via all three reporting
mechanisms (claims, registry, and EHR)
for the 12-month 2014 payment
adjustment reporting period. We note
that, according to the 2009 Reporting
Experience available on our Web site at
www.cms.gov/eRxincentive/, the claimsbased reporting mechanism was the
most widely used reporting mechanism
in 2009. Therefore, it follows that we
anticipate that most eligible
professionals and group practices
participating in the eRx Incentive
Program for the 2013 and 2014 payment
adjustment would do so via the claimsbased reporting mechanism.
Comment: One commenter urged us
to allow group practices participating in
the eRx GPRO to change their method
of reporting during the reporting period.
Response: We appreciate the
commenter’s feedback. However,
because it would be a substantial
operational burden to analyze group
practice reporting via multiple reporting
mechanisms, we must require that
group practices choose only one method
of reporting during the reporting period.
Regardless, we note that all three
reporting mechanisms—claims, registry,
and EHR—are available for reporting
under the eRx GPRO.
After considering the comments
received and for the reasons stated in
our responses, we are finalizing the
following reporting mechanisms for the
12-month reporting periods for the 2012
and 2013 incentives, and the 2014
payment adjustment: claims, registry,
and EHR. The requirements for each
reporting mechanism with respect to the
2012 and 2013 incentives and 2013 and
2014 payment adjustments are
described below. In this final rule, we
also are finalizing the claims-based
reporting mechanism for the 6-month
reporting periods pertaining to the 2013
and 2014 payment adjustments;
however, as we explained previously,
we are not finalizing registry or EHRbased reporting for these 6-month
reporting periods. We are therefore
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modifying 42 CFR 414.92 to reflect that
only the claims-based reporting
mechanism may be used for purposes of
the 6-month 2013 and 2014 payment
adjustment reporting periods.
(1) Claims-Based Reporting
For purposes of reporting the
electronic prescribing quality measure
for the 2012 and 2013 incentives and
the 2013 and 2014 payment
adjustments, we proposed (75 FR 42890
and 42891) to again retain the claimsbased reporting mechanism that has
been used since the implementation of
the eRx Incentive Program in 2009. We
did not propose any prerequisites, such
as registration, to begin reporting on the
electronic prescribing quality measure
via claims. Retaining the claims-based
mechanism allows eligible professionals
and group practices to begin to report on
the electronic prescribing quality
measure without the added cost of
submitting data to a registry or
purchasing an EHR system (if the
eligible professional is using a
standalone eRx system) as eligible
professionals already report PFS charges
via claims.
The following is a summary of the
only comment we received regarding
this proposal.
Comment: One commenter urged us
to continue to offer the claims-based
reporting mechanism until the registry
and EHR-based reporting mechanisms
are widely used.
Response: We agree and are finalizing
the claims-based reporting mechanism.
We are finalizing the claims-based
reporting mechanism for purposes of
reporting the electronic prescribing
quality measure for the 2012 and 2013
incentives and the 2013 and 2014
payment adjustments. Accordingly, we
are modifying 42 CFR 414.92 to reflect
our decision to finalize this proposal.
In the proposed rule, we also
proposed that if an eligible professional
or group practice chooses the claimsbased reporting mechanism, the eligible
professional or group practice must
directly submit data on the electronic
prescribing quality measure (76 FR
42890). For eligible professionals and
group practices participating in the eRx
GPRO using the claims-based reporting
mechanism for purposes of reporting the
electronic prescribing measure during a
12-month incentive or payment
adjustment reporting period, we
proposed that all claims for services
must be processed by us no later than
two months after the respective
reporting period, for the claim to be
included in our data analysis. (For
example, for an eligible professional
using the 12-month, 2014 payment
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73401
adjustment reporting period, all claims
for services between January 1, 2012
and December 31, 2012 must be
processed no later than February 22,
2013 to be included in our data
analysis.) For eligible professionals and
group practices using the claims-based
reporting mechanism for purposes of
reporting the electronic prescribing
measure during a 6-month payment
adjustment reporting period, we
proposed that all claims for services
must be processed by us by no later than
one month after the respective reporting
period, for the claim to be included in
our data analysis. (For example, for an
eligible professional using the 6-month,
2013 payment adjustment reporting
period, all claims for services between
January 1, 2012 and June 30, 2012 must
be processed no later than July 27, 2012,
for the claims to be included in our data
analysis.) We invited but did not receive
any public comment regarding the
processing of claims. Therefore, for the
reasons explained, we are finalizing
these requirements. We believe that
these requirements for using the claimsbased reporting mechanism will allow
sufficient time for eligible professionals
to report the electronic prescribing
measure, allow us to collect and analyze
the data submitted by eligible
professionals, and avoid retroactive
adjustments of payments.
(2) Registry-Based Reporting
For purposes of reporting for the 2012
and 2013 incentives and the 2013 and
2014 payment adjustments, we
proposed (76 FR 42891) to continue the
registry-based reporting mechanism first
introduced under the 2010 eRx
Incentive Program. We believed this
would provide an opportunity for
individual eligible professionals and
group practices who choose to
participate in the Physician Quality
Reporting System via registry to use the
same reporting mechanism for reporting
the electronic prescribing measure, and
this would provide eligible
professionals and group practices with
another alternative reporting
mechanism. In addition, unlike claimsbased reporting, although there may be
a cost associated with submitting data to
a registry, reporting of the electronic
prescribing measure to CMS is done
entirely by the registry.
We also proposed that only registries
qualified to submit quality measure
results and numerator and denominator
data on quality measures on behalf of
eligible professionals for the Physician
Quality Reporting System for the
applicable calendar year would be
qualified to submit measure results and
numerator and denominator data on the
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electronic prescribing measure on behalf
of eligible professionals for the eRx
Incentive Program.
Some registries that self-nominate to
become a qualified registry for the
Physician Quality Reporting System
may not choose to self-nominate to
become a qualified registry for purposes
for the eRx Incentive Program. We
proposed that registries that want to
qualify would need to submit measure
results and numerator and denominator
data on the electronic prescribing
measure for reporting periods that occur
during CYs 2012 and 2013 at the time
that they submit their self-nomination
letter for the 2012 and 2013 Physician
Quality Reporting System, respectively.
The self-nomination process and
requirements for registries for the
Physician Quality Reporting System,
which also will apply to the registries
for the eRx Incentive Program, are
discussed in the Physician Quality
Reporting System section VI.F.1.(d).(2).
of this final rule with comment period.
We will post a final list of qualified
registries for the eRx Incentive Program
for CYs 2012 and 2013 on the eRx
Incentive Program section of the CMS
Web site at https://www.cms.gov/
ERXIncentive when we post the final
list of qualified registries for the
Physician Quality Reporting System for
2012 and 2013 respectively on the
Physician Quality Reporting System
section of the CMS Web site.
Since we proposed a 12-month
reporting period for purposes of the
2012 and 2013 incentive and 6 and 12month reporting periods for purposes of
the 2013 and 2014 payment adjustments
(as described in the section previously),
we further proposed that qualified
registries would need to submit the
electronic prescribing measure for the
eRx Incentive Program to us in two
separate transmissions, based on the
proposed reporting periods for the 2012
and 2013 incentive payments and 2013
and 2014 payment adjustments.
Specifically, we proposed that qualified
registries would need to submit 2012
and 2013 data on the electronic
prescribing measure in two separate
submissions:
• Following the end of the respective
6-month payment adjustment reporting
period (between July 1, 2012 and
August 19, 2012, for purposes of the
2013 eRx payment adjustment, and
between July 1, 2013 and August 19,
2013, for purposes of the 2014 eRx
payment adjustment); and
• Following the end of the 12-month
reporting period for the 2012 and 2013
incentives and 2014 payment
adjustment.
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We invited public comment but
received no comments on our proposed
requirements for registry-based
reporting for purposes of reporting for
the 2012 and 2013 incentives, as well as
for reporting during the 6-month and
12-month reporting periods for the 2013
and 2014 payment adjustments. We are
modifying 42 CFR 414.92 to finalize the
requirements for registry-based
reporting for purpose of the 12-month
reporting periods for the 2012 and 2013
incentives, and the 2014 payment
adjustment. As stated previously, due to
the operational issues associated with
ensuring that qualified registries are
able to allow for an additional
submission instance, we are not
finalizing registry-based reporting for
the 6-month reporting periods for the
2013 and 2014 payment adjustments,
and therefore, are not finalizing the
corresponding registry requirements
that we proposed. Therefore, qualified
registries must submit the electronic
prescribing quality measure for the eRx
Incentive Program to us in one
transmission, for the 12-month reporting
periods applicable for the 2012 and
2013 incentive payments and the 2013
and 2014 payment adjustments.
Specifically, qualified registries must
submit 2012 and 2013 data on the
electronic prescribing quality measure
following the end of the respective 12month reporting period for the 2012 and
2013 incentives and the 2014 payment
adjustment.
(3) EHR-Based Reporting
For purposes of reporting for the 2012
and 2013 incentives and the 2014
payment adjustment, we proposed (76
FR 42891–42892) to retain the EHRbased reporting mechanism to
encourage the use of EHR technology as
well as provide eligible professionals
and group practices with a third
reporting option. We proposed this
reporting mechanism to provide an
opportunity for eligible professionals
and group practices who choose to
participate in the Physician Quality
Reporting System via EHR, as well as
eligible professionals who participate in
the Medicaid or Medicare EHR
Incentive Program, to use the same
reporting mechanism for reporting the
electronic prescribing measure under
the eRx Incentive Program.
We proposed that EHR technology
and EHR data submission vendors (as
described by the Physician Quality
Reporting System) ‘‘qualified’’ to submit
extracted Medicare clinical quality data
to us for the Physician Quality
Reporting System would be able to be
used by an eligible professional or group
practice to submit data on the electronic
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prescribing measure for the 2012 and
2013 incentives and 2014 payment
adjustment. The proposed selfnomination process and requirements
for direct EHR-based reporting products
and EHR data submission vendors for
the Physician Quality Reporting System
as discussed previously the proposed
rule (76 FR 42846) would apply to the
EHR products and EHR data submission
vendors for the eRx Incentive Program.
We hoped this third reporting option for
eligible professionals and group
practices would encourage the use of
EHR technology.
We also proposed that direct EHRbased reporting vendors and EHR data
submission vendors must indicate their
desire to have one or more of their EHR
products approved for use in the eRx
Incentive Program for the reporting
periods that occur in CYs 2012 and 2013
at the same time they self-nominate for
the respective 2012 and 2013 Physician
Quality Reporting System. We further
noted that a list of approved EHR
technology, their vendors (including the
technology’s version that is approved)
for the eRx Incentive Program would be
posted on the eRx Incentive Program
section of the CMS Web site at https://
www.cms.gov/ERXIncentive when we
posted the list of approved EHR
technology for the Physician Quality
Reporting System.
We also proposed that eligible
professionals using their approved EHR
systems must submit the electronic
prescribing measure for the eRx
Incentive Program to us in two separate
submissions—
• Following the end of the respective
6-month payment adjustment reporting
period (between July 1, 2012 and
August 19, 2012, for purposes of the
2013 eRx payment adjustment, and
between July 1, 2013 and August 19,
2013, for purposes of the 2014 eRx
payment adjustment); and
• Following the end of the 12-month
reporting period for the 2012 and 2013
incentives and 2014 payment
adjustment.
Similarly, we proposed that EHR data
submission vendors must submit the
electronic prescribing measure to on
behalf of eligible professionals to us in
two separate submissions:
• Following the end of the respective
6-month payment adjustment reporting
period (between July 1, 2012 and
August 19, 2012, for purposes of the
2013 eRx payment adjustment, and
between July 1, 2013 and August 19,
2013, for purposes of the 2014 eRx
payment adjustment); and
• Following the end of the 12-month
reporting period for the 2012 and 2013
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incentives and 2014 payment
adjustment.
We invited public comment but
received no comments on our proposed
requirements for EHR-based reporting
for purposes of reporting for the 2012
and 2013 incentives and the 2013 and
2014 payment adjustments. As noted
previously, however, we are not
finalizing EHR-based reporting for the 6month reporting periods for the 2013
and 2014 payment adjustments.
Therefore, in this final rule with
comment period, we are only finalizing
the requirements discussed previously
for reporting the electronic prescribing
measure via the EHR-based reporting
mechanism for the 12-month reporting
period for the 2012 and 2013 incentives
and the 2014 payment adjustment. We
are modifying 42 CFR 414.92 to reflect
these final requirements for EHR-based
reporting.
g. The 2012 and 2013 eRx Incentives
42 CFR 414.92(d) governs the
requirements for individual eligible
professionals to qualify to receive an
incentive payment. We proposed (76 FR
42892) to modify 42 CFR 414.92(d) to
add the words ‘‘being a,’’ so that the
provision reads:
In order to be considered a successful
electronic prescriber and qualify to earn an
electronic prescribing incentive payment
(subject to paragraph (c)(3) of this section), an
individual eligible professional, as identified
by a unique TIN/NPI combination, must meet
the criteria for being a successful electronic
prescriber under section 1848(m)(3)(B) of the
Act and as specified by CMS during the
reporting period specified in paragraph (d)(1)
of this section and using one of the reporting
mechanisms specified in paragraph (d)(2) of
this section. Although an eligible
professional may attempt to qualify for the
electronic prescribing incentive payment
using more than one reporting mechanism (as
specified in paragraph (d)(2) of this section),
the eligible professional will receive only one
electronic prescribing incentive payment per
TIN/NPI combination for a program year.
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We invited but did not receive any
public comment on our proposal to
make the technical change to 42 CFR
414.92(d). Therefore, since we believe
this change provides more clarity to the
provision, we are finalizing this
proposed change.
(1) Applicability of 2012 and 2013 eRx
Incentives for Eligible Professionals and
Group Practices
Section 1848(m)(2)(B) of the Act
imposes a limitation on the applicability
of the eRx incentive payment. The
Secretary is authorized to choose 1 of 2
possible criteria for determining
whether or not the limitation applies to
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an eligible professional (or group
practice)—
• Whether Medicare Part B allowed
charges for covered professional
services furnished by the eligible
professional (or group practice) for the
codes to which the electronic
prescribing quality measure applies are
less than 10 percent of the total
Medicare Part B PFS allowed charges for
all such covered professional services
furnished by the eligible professional
during the reporting period; OR
• Whether the eligible professional
submits (both electronically and nonelectronically) a sufficient number (as
determined by the Secretary) of
prescriptions under Part D (which can,
again, be assessed using Part D drug
claims data). If the Secretary decides to
use this criterion, the criterion based on
the reporting on electronic prescribing
measures would no longer apply.
Based on our proposal to make the
determination of whether an eligible
professional or group practice is a
‘‘successful electronic prescriber’’ based
on submission of the electronic
prescribing measure (the first criterion),
we proposed (76 FR 42892) to apply the
criterion under section 1848(m)(2)(B)(i)
of the Act for the limitation for both the
2012 and 2013 incentives. We invited
but received no public comment on our
proposal. Therefore, the 2012 and/or
2013 incentive is not applicable if the
Medicare Part B allowed charges for
covered professional services furnished
by the eligible professional (or group
practice) for the codes to which the
electronic prescribing quality measure
applies are less than 10 percent of the
total Medicare Part B PFS allowed
charges for all covered professional
services furnished by the eligible
professional or group practice during
the reporting period.
For purposes of the 2012 and 2013
incentives, this analysis would be
performed during the first quarters of
2013 and 2014 respectively by dividing
the eligible professional’s or
participating group practice’s total 2012
and 2013 respective Medicare Part B
PFS allowed charges for all such
covered professional services submitted
for the measure’s denominator codes by
the eligible professional’s or group
practices’ total Medicare Part B PFS
allowed charges for all covered
professional services. If the result is 10
percent or more, then the statutory
limitation will not apply and a
successful electronic prescriber would
qualify to earn the electronic prescribing
incentive payment. If the result is less
than 10 percent, then the statutory
limitation will apply, and the eligible
professional or group practice will not
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73403
earn an electronic prescribing incentive
payment even if he or she meets the
reporting criteria for being a successful
electronic prescriber. Although an
individual eligible professional or group
practice may decide to conduct his or
her own assessment of how likely this
statutory limitation is expected to apply
to him or her before deciding whether
or not to report the electronic
prescribing measure, an individual
eligible professional or group practice
may report the electronic prescribing
measure without regard to the statutory
limitation for the incentive payment.
(2) Reporting Criteria for Being a
Successful Electronic for the 2012 and
2013 eRx Incentives—Individual
Eligible Professionals
Section 1848(m)(3)(D) of the Act
authorizes the Secretary to revise the
criteria for submitting data on the
electronic prescribing measure under
section 1848(m)(3)(B)(ii) of the Act,
which requires the measure to be
reported in at least 50 percent of the
cases in which the measure is
reportable.
For the 2012 and 2013 incentives, to
maintain program consistency from year
to year, we proposed (76 FR 42892) to
make the determination of whether an
individual eligible professional is a
successful electronic prescriber for
purposes of the incentive based on a
count of the number of times (minimum
threshold of 25) an eligible professional
reports that at least one prescription
created during the denominator-eligible
encounter is generated using a qualified
electronic prescribing system, which
would include Certified EHR
Technology (that is, reports the G8553
code when the eligible professional bills
for one of the services included in the
measure’s denominator). We believe this
criterion adequately addresses the goal
of the eRx Incentive Program,
specifically to promote the use of
electronic prescribing systems.
We invited public comment on the
proposed criteria for successful
electronic prescriber and the following
is a summary of the comments we
received.
Comment: One commenter supported
our proposed criteria for being a
successful electronic prescriber for
purposes of the 2012 and 2013
incentives, further stating that reporting
the electronic prescribing measure for
25 unique visits is a reasonable and
attainable threshold.
Response: We appreciate the
commenter’s feedback and are finalizing
our proposal to base the determination
of whether or not an eligible
professional is a successful electronic
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prescriber for the 2012 and 2013
incentives by reporting on the electronic
prescribing measure for at least 25
unique visits.
Comment: A few commenters
suggested that we reduce the number of
times an eligible professional is required
to report the electronic prescribing
measure for purposes of the 2012 and
2013 incentives to 10 unique visits,
similar to the reporting requirements for
the 2013 and 2014 payment
adjustments.
Response: We appreciate the
commenters’ feedback. However, we
proposed this reporting criterion for the
2012 and 2013 incentives because the
criterion parallels the criterion
established for the 2011 incentive. We
believe that it is in the eligible
professional’s best interest to provide
uniform year-to-year reporting
requirements for purposes of earning an
incentive. In addition, we note that
whereas the 10 count criteria for
reporting the electronic prescribing
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measure for a payment adjustment
applies to a 6-month reporting period,
this 25 count criteria for earning an
incentive applies to a 12-month
reporting period. Since the requirement
to report 25 times is based on a longer
reporting period, we believe it is
reasonable to require a higher reporting
threshold for purposes of the 2012 and
2013 incentives, than what was required
for the 2012 payment adjustment (which
was based on a shorter, 6-month
reporting period).
Comment: Several commenters
encouraged us to align the reporting
requirements for the 2012 and 2013
incentives with the reporting
requirements for the 2013 and 2014
payment adjustments by allowing the
reporting of the electronic prescribing
measure’s numerator for nondenominator-eligible visits.
Response: We appreciate the
commenters’ feedback. However, as we
stated previously, we do not believe that
the reporting criteria for becoming a
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successful electronic prescriber for the
incentives and payment adjustments
need to be identical. Rather, we believe
that, although the incentives and
payment adjustments were both
implemented to encourage the use of
electronic prescribing, the criteria to
become a successful electronic
prescriber for purposes of the 2012 and
2013 incentives should be more
stringent.
After considering the comments
received and for the reasons stated in
our responses, for the 2012 and 2013
incentives, we are finalizing the criteria
for being a successful electronic
prescriber as proposed for individual
eligible professionals . A summary of
the finalized criteria for being a
successful electronic prescriber for
purposes of the 2012 and 2013
incentives are described in the
following Tables 73 and 74.
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(3) Criteria for Being a Successful
Electronic Prescriber 2012 and 2013 eRx
Incentives—Group Practices
Under section 1848(m)(3)(B) of the
Act, in order to qualify for the incentive
payment, an eligible professional or
group practice must be a ‘‘successful
electronic prescriber.’’ To simplify the
reporting criteria for group practices
using the eRx GPRO used in prior years,
we proposed (76 FR 42893) that, for the
2012 and 2013 incentive payments, to
be a successful prescriber, a group
practice using the eRx GPRO must
report the electronic prescribing
measure’s numerator for at least 625
unique visits (for group practices
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comprised of 25–99 eligible
professionals) or 2,500 unique visits (for
group practices comprised of 100 or
more eligible professionals) during the
applicable reporting period. To obtain
these reporting criteria, we multiplied
the smallest group practice size for each
respective threshold (that is, 25 for the
first threshold and 100 for the second
threshold) by the number of unique
visits (25) an individual eligible
professional must report on the
electronic prescribing measure in order
to qualify for an incentive payment.
Although this may be a higher reporting
threshold for group practices using the
eRx GPRO comprised of 25–50 eligible
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professionals and group practices using
the eRx GPRO comprised of 101–199
eligible professionals than in 2011, we
believe it is still quite feasible for these
group practices to meet the respective
reporting threshold as this would be the
reporting threshold should the members
of the group practice choose to
participate in the eRx Incentive Program
as individual eligible professionals.
We invited but received no public
comments on the proposed criteria for
determining successful electronic
prescribers for group practices reporting
under the eRx GPRO reporting option
for purposes of earning the 2012 and
2013 incentives. Therefore, we are
finalizing the criteria as proposed. The
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criteria for being successful electronic
prescribers for group practices using the
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eRx GPRO reporting option for purposes
of the 2012and 2013 incentive are
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summarized in the following Tables 75
and 76.
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(4) No Double Payments
We are prohibited from making
double payments under section
1848(m)(3)(C)(iii) of the Act, which
requires that payments to a group
practice shall be in lieu of the payments
that would otherwise be made under the
eRx Incentive Program to eligible
professionals individually in the group
practice for being a successful electronic
prescriber. Accordingly, we proposed
(76 FR 42893) to make incentive
payments to group practices based on
the determination that the group
practice, as a whole, is a successful
electronic prescriber for the respective
program year. An individual eligible
professional who is affiliated with a
group practice participating in the eRx
GPRO reporting option that meets the
requirements of being a successful
electronic prescriber under a group
practice would not be eligible to earn a
separate eRx incentive payment on the
basis of the individual eligible
professional meeting the criteria for
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successful electronic reporter at the
individual level.
We invited but received no public
comment on our proposal to prohibit
double payments and are therefore
finalizing this proposal. We also
proposed to make a technical change to
42 CFR 414.92(g)(5)(ii) to modify
‘‘another’’ to ‘‘a’’ to clarify the
provision. However, we inadvertently
listed the wrong provision. The
provision that we intended to modify
was 42 CFR 414.92(e)(2)(ii). Since we
believe this technical change will not
substantively affect the regulation and
believe this technical change will clarify
this provision, we are making a
technical change to modify ‘‘another’’ to
‘‘a’’ under 42 CFR 414.92(e)(2)(ii).
h. The 2013 and 2014 Electronic
Prescribing Payment Adjustments
As previously stated, for 2012, 2013,
and 2014, if the eligible professional is
not a successful electronic prescriber for
the reporting period for the year, the
PFS amount for covered professional
services furnished by such professionals
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during the year shall be less than the
PFS amount that would otherwise apply
by—
• 1.0 percent for 2012;
• 1.5 percent for 2013; and
• 2.0 percent for 2014.
We proposed (76 FR 42893) to modify
42 CFR 414.92 to provide further
explanation of the requirements for
individual eligible professionals and
group practices for the 2013 and 2014
payment adjustment, as described later
in this section. Paragraph 42 CFR
414.92(f) was designated to address
‘‘public reporting of an eligible
professional’s or group practice’s
Electronic Prescribing Incentive
Program data.’’ However, we are
redesignating this paragraph as 42 CFR
414.92(g). In its place, we are
redesignating paragraph (f) so that
414.92(f) addresses the requirements for
the 2013 and 2014 payment
adjustments.
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(1) Limitations to the 2013 and 2014 eRx
Payment Adjustments—Individual
Eligible Professionals
Whereas we believe that an incentive
should be broadly available to
encourage the widest possible adoption
of electronic prescribing, even for low
volume prescribers, we believe that a
payment adjustment should be applied
primarily to assure that those who have
a large volume of prescribing do so
electronically, without penalizing those
for whom the adoption and use of an
electronic prescribing system may be
impractical given the low volume of
prescribing. We proposed (76 FR 42893
through 42899) limitations on the
applicability of the 2013 and 2014
payment adjustments. Specifically, we
proposed that the 2013 and 2014
payment adjustments would not apply
if:
• An eligible professional is not an
MD, DO, podiatrist, nurse practitioner,
or physician assistant as of June 30,
2012, for purposes of the 2013 payment
adjustment and June 30, 2013, for
purposes of the 2014 payment
adjustment. Since these eligible
professionals do not generally prescribe,
we have excluded these eligible
professionals from the eRx Incentive
Program.
For purposes of determining whether
an eligible professional is an MD, DO,
podiatrist, nurse practitioner, or
physician assistant we would use
National Plan and Provider
Enumeration System (NPPES) data. It is
an eligible professional’s responsibility
to ensure that his or her primary
taxonomy code in NPPES is accurate.
However, in 2011, we also established a
G-code, (G8644) that eligible
professionals can use to report to us that
they do not have prescribing privileges.
We proposed to retain the reporting of
this G-code for purposes of the 2013 and
2014 payment adjustments. For
purposes of the 2013 payment
adjustment, we proposed that eligible
professionals who report this G-code
must do so on a claim with dates of
services during the 6-month reporting
period (January 1, 2012 and June 30,
2012). For purposes of the 2014
payment adjustment, we proposed that
eligible professionals who report this Gcode must do so on a claim with dates
of services during the 6-month reporting
period (January 1, 2013 and June 30,
2013) so that we are able to distinguish
whether a professional is reporting this
G-code for the 2013 payment adjustment
or the 2014 payment adjustment.
• The eligible professional’s Medicare
Part B allowed charges for covered
professional services to which the
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electronic prescribing quality measure
applies are less than 10 percent of the
total Medicare Part B PFS allowed
charges for all covered professional
services furnished by the eligible
professional during the respective
payment adjustment reporting period.
This is a required limitation under
section 1848(m)(2)(B) of the Act. This
calculation will be performed by
dividing the eligible professional’s total
2011 Medicare Part B PFS allowed
charges for all such covered professional
services submitted for the measure’s
denominator codes by the eligible
professional’s total Medicare Part B PFS
allowed charges for all covered
professional services (as assessed at the
TIN/NPI level). If the result is 10
percent or more, then the statutory
limitation will not apply. If the result is
less than 10 percent, then the statutory
limitation will apply. For the 12-month
incentive and payment adjustment
reporting periods, this calculation is
expected to take place in the first
quarter of the year following the
reporting period (for example, in the
first quarter of 2013 for the 12-month
reporting period for the 2012 incentive).
For the 6-month payment adjustment
reporting period, this calculation is
expected to take place within the
calendar year for the respective 6-month
reporting period (for example, within
2012 for the 6-month reporting period
for the 2013 payment adjustment).
• An eligible professional does not
have at least 100 cases (that is, claims
for patient services) containing an
encounter code that falls within the
denominator of the electronic
prescribing measure for dates of service
during: the 6-month reporting period
(January 1, 2012 through June 30, 2012)
for the 2013 payment adjustment or the
6-month reporting period (January 1,
2013 through June 30, 2013) for the
2014 payment adjustment. If an eligible
professional has less than 100
denominator-eligible instances in a 6month period, this will be an indicator
to us that the professional likely has a
small Medicare patient population.
We invited but received no public
comment on our proposed limitations to
the 2013 and 2014 eRx payment
adjustments for individual eligible
professionals. Therefore, we are
finalizing all of the above limitations to
the 2013 and 2014 eRx payment
adjustments for individual eligible
professionals as proposed, as set forth at
42 CFR 414.92.
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(2) Requirements for the 2013 and 2014
eRx Payment Adjustments—Individual
Eligible Professionals
Section 1848(a)(5) of the Act requires
a payment adjustment to be applied
with respect to covered professional
services furnished by an eligible
professional in 2013 and 2014, if the
eligible professional is not a successful
electronic prescriber, as set forth in
section 1848(m)(3)(B) of the Act, for the
reporting period for the year. Section
1848(m)(3)(D) of the Act authorizes the
Secretary to revise the criteria for
submitting data on the electronic
prescribing quality measure. In the 2011
PFS Final Rule with comment period,
we established the same reporting
criteria for being a successful electronic
prescriber for purposes of the 2011
incentive and the 2013 payment
adjustment, based on a 12-month
reporting period in 2011 (75 FR 73565).
In order to create another opportunity
for an eligible professional to become a
successful electronic prescriber for
purposes of the 2013 payment
adjustment, we proposed (76 FR 42894)
that, based on the proposed 6-month
reporting period, an eligible
professional would be a successful
electronic prescriber if he/she reports
the electronic prescribing measure’s
numerator, that is, at least 1 prescription
for Medicare Part B PFS patients was
created during an encounter was
generated and transmitted electronically
using a qualified electronic prescribing
system at least 10 times during the 6month payment adjustment reporting
period (that is, January 1, 2012 through
June 30, 2012). Unlike the reporting
criteria for the incentive payments
where the numerator must be reported
in connection with a denominatoreligible visit, for purposes of the 2013
and 2014 payment adjustments, we
proposed that an eligible professional
would be able to report the measure’s
numerator for any Medicare Part B PFS
service provided during the reporting
period, regardless of whether the code
for such service appears in the
denominator, because we recognize that
eligible professionals may generate
prescriptions during encounters that are
not necessarily included in the
measure’s denominator.
We also sought to provide more than
one opportunity for eligible
professionals to avoid the 2014 payment
adjustment by becoming a successful
electronic prescriber. Therefore,
consistent with the final criteria for
successful electronic prescribing for
purposes of the 2013 payment
adjustment, we proposed (76 FR 42894
and 42895) the following criteria for an
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eligible professional to be a successful
electronic prescriber for purposes of the
2014 payment adjustment: (1) An
eligible professional meets the criteria
for the 2013 incentive, that is, reports
that at least one prescription for a
Medicare Part B PFS patient created
during an encounter was generated and
transmitted electronically using a
qualified electronic prescribing system
for at least 25 denominator-eligible
encounters during the 12-month
payment adjustment reporting period
(that is, January 1, 2012 through
December 31, 2012), or (2) An eligible
professional reports the electronic
prescribing measure’s numerator (that
is, that at least 1 prescription for a
Medicare Part B PFS patient created
during an encounter was generated and
transmitted electronically using a
qualified electronic prescribing system)
at least 10 times during the 6-month
payment adjustment reporting period
(that is, January 1, 2013 through June
30, 2013).
As with the 2012 and 2013 incentive
payments, we proposed that the
determination of whether an eligible
professional is subject to the payment
adjustment would be made at the
individual professional level, based on
the NPI and for each unique TIN/NPI
combination.
We proposed the previous criteria for
being a successful electronic prescriber
for purposes of the 2013 and 2014
payment adjustments because, aside
from not requiring the reporting of the
electronic prescribing measure’s
numerator for denominator-eligible
encounters (which only applies to the 6month, 2013 and 2014 payment
adjustment reporting periods), they are
consistent with the criteria for being a
successful electronic prescriber for
purposes of the 2012 and 2013 payment
adjustments that were finalized in the
CY 2011 PFS final rule with comment
period (75 FR 73562 through 73565).
We invited public comment on the
proposed criteria for being a successful
electronic prescriber for the 2013 and
2014 payment adjustments for
individual eligible professionals. The
following is a summary of the comments
received regarding these proposals.
Comment: Some commenters
supported our proposal to simplify the
payment adjustment reporting criteria
by proposing criteria for the 2013 and
2014 payment adjustments (to report on
the electronic prescribing measure’s
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numerator for at least 10 unique visits
during the respective 6-month reporting
periods for the 2013 and 2014 payment
adjustments) that are parallel to criteria
established for the 2011 payment
adjustment, aside from not requiring the
reporting of the electronic prescribing
measure’s numerator for denominatoreligible encounters.
Response: We appreciate the
commenters’ support. For the 2013 and
2014 payment adjustments, we are
finalizing the proposed reporting
criteria for being a successful electronic
prescriber for individual eligible
professionals. Note that, for the 6-month
reporting periods alone for 2013 and
2014 payment adjustments, eligible
professionals are not required to report
on an electronic prescribing event tied
to a denominator-eligible encounter.
Rather, eligible professionals may report
on an electronic prescribing event for
any unique visit.
Comment: Several commenters
supported our proposal to allow
reporting of the electronic prescribing
measure for visits not associated with
the electronic prescribing measure’s
denominator for purposes of the 2013
and 2014 payment adjustments.
Response: We appreciate the
commenters’ support of our proposal
and are finalizing our proposal to allow
for reporting of the electronic
prescribing measure for visits not
associated with the electronic
prescribing measure’s denominator for
purposes of the 2013 and 2014 payment
adjustments.
Comment: One commenter stated that
the criteria we proposed for individual
eligible professionals to become
successful electronic prescribers for
purposes of the 2013 and 2014 payment
adjustment is too low. The commenter
stated that, similar to the criteria
required for achieving meaningful use
under the EHR Incentive Program, we
should require eligible professionals to
report on at least 40 percent of all
electronic prescriptions. At a minimum,
the commenter believed the eligible
professionals should use the 2012 and
2013 incentive criteria for purposes of
the 2013 and 2014 payment adjustment.
Response: We appreciate the
commenters’ feedback. However, we
proposed these criteria for being a
successful electronic prescriber for the
2013 and 2014 payment adjustments
because we believe these criteria
achieve our goal of encouraging eligible
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professionals to utilize electronic
prescribing systems. Furthermore, as we
noted, we previously finalized criteria
for being a successful electronic
prescriber for the 2013 payment
adjustment that are identical to the
criteria finalized for the 2011 incentive.
Likewise, we proposed and are
finalizing criteria for becoming a
successful electronic prescriber for the
2014 payment adjustment that are
identical to the criteria we finalized for
the 2012 incentive.
After considering the comments
received and for the reasons stated
above, we are finalizing the proposed
criteria for individual eligible
professionals to be successful electronic
prescribers for purposes of the 2013 and
2014 payment adjustments. Specifically,
for purposes of the 2013 payment
adjustment, an individual eligible
professional is a successful electronic
prescriber if an eligible professional
reports the electronic prescribing
measure’s numerator at least 10 times
during the 6-month 2013 payment
adjustment reporting period (that is,
January 1, 2012 through June 30, 2012,
regardless of whether the encounter is
associated with at least one
denominator code of the electronic
prescribing measure). For purposes of
the 2014 payment adjustment, an
eligible professional is a successful
electronic prescriber if: (1) An eligible
professional reports that at least one
prescription for Medicare Part B PFS
patients created during an encounter
was generated and transmitted
electronically using a qualified
electronic prescribing system for at least
25 denominator-eligible visits during
the 12-month payment adjustment
reporting period (that is, January 1, 2012
through December 31, 2012) (note that
this is the same criteria for the 2013
incentive); or (2) an eligible professional
reports the electronic prescribing
measure’s numerator at least 10 times
during the 6-month payment adjustment
reporting period (that is, January 1, 2013
through June 30, 2013). Tables 77 and
78 reflect the final criteria we are
adopting in this final rule with
comment period for being a successful
electronic prescriber for an individual
eligible professional for purposes of the
2013 and 2014 payment adjustments,
respectively.
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transmitted electronically using a
qualified electronic prescribing system)
at least 625 times (for group practices
comprised of 25 to 99 eligible
professionals) or 2,500 times (for group
practices comprised of 100+ eligible
professionals).
Similarly, for the 2014 payment
adjustment, we proposed (76 FR 42895)
the following: A group practice would
be a successful electronic prescriber if
the group practice meets the 2012
criteria for being a successful electronic
prescriber for purposes of the 2012
incentive payment. In other words, the
group practice would need to report the
electronic prescribing measure’s
numerator for at least 625 (for group
practices comprised of 25 to 99 eligible
professionals) or 2,500 (for group
practices comprised of 100 or more
eligible professionals) times for
encounters associated with at least 1 of
the denominator code that occurs
between January 1, 2012 and December
31, 2012. In addition, we proposed that
a group practice would also be a
successful electronic prescriber for
purposes of the 2014 payment
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adjustment if, during the 6-month
reporting period (January 1, 2013
through June 30, 2013), a group practice
reports the electronic prescribing
measure’s numerator (that is, that at
least 1 prescription for Medicare Part B
PFS patients created during an
encounter was generated and
transmitted electronically using a
qualified electronic prescribing system)
at least 625 times (for group practices
with 25 to 99 eligible professionals) or
2,500 times (for group practices with
100+ eligible professionals).
We invited but received no public
comments on the proposed criteria for
being a successful electronic prescriber
for group practices under the eRx
GPROs for the 2013 and 2014 electronic
prescribing payment adjustments.
Therefore, we are finalizing our
proposed criteria for the 2013 and 2014
payment adjustment as proposed. 79
and 80 summarize the criteria for being
a successful electronic prescriber for a
group practice for purposes of the 2013
and 2014 payment adjustments,
respectively.
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(3) Requirements for the 2013 and 2014
eRx Payment Adjustments—Group
Practices
Under section 1848(m)(3)(C) of the
Act, we are also required to establish
and have in place a process under
which eligible professionals in a group
practice shall be treated as a successful
electronic prescriber for purposes of the
payment adjustment. For purposes of
the 2013 and 2014 payment
adjustments, we proposed (76 FR 42895)
that if a group practice chooses to
participate in the eRx GPRO during CYs
2012 and 2013, respectively, then the
group practice would be evaluated for
applicability of the 2013 and 2014
payment adjustment as a group practice.
We proposed (76 FR 42895) an eRx
GPRO would be a successful electronic
prescriber for purposes of the 2013
payment adjustment if, during the 6month reporting period (January 1, 2012
through June 30, 2012), a group practice
reports the electronic prescribing
measure’s numerator (that is, that at
least 1 prescription for Medicare Part B
PFS patients created during an
encounter was generated and
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In addition, in accordance with the
limitation under section
1848(m)(2)(B)(i) of the Act, the 2013 or
2014 payment adjustment does not
apply to a group practice in which less
than 10 percent of the group practice’s
estimated total allowed charges for the
respective 6-month or 12-month
payment adjustment reporting period
are comprised of services which appear
in the denominator of the 2012 or 2013
electronic prescribing measure. To be
consistent with how this limitation is
applied to group practices for purposes
of the incentive, we proposed to
determine whether this limitation
applies to a group practice for the
payment adjustment at the TIN level.
Because we received no public
comment on this proposal, we are
finalizing this proposal as proposed.
(4) Significant Hardship Exemptions
Section 1848(a)(5)(B) of the Act
provides that the Secretary may, on a
case-by-case basis, exempt an eligible
professional from the application of the
payment adjustment, if the Secretary
determines, subject to annual renewal,
that compliance with the requirement
for being a successful electronic
prescriber would result in a significant
hardship.
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(A) Significant Hardship Exemptions
In the CY 2011 PFS final rule with
comment period (75 FR 73564 through
75 FR 73565), we finalized two
circumstances under which an eligible
professional or eRx GPRO can request
consideration for a significant hardship
exemption for the 2012 eRx payment
adjustment:
• The eligible professional or group
practice practices in a rural area with
limited high speed internet access.
• The eligible professional or group
practice practices in an area with
limited available pharmacies for
electronic prescribing.
For the 2013 and 2014 payment
adjustments, we proposed (76 FR 42896)
to retain these two significant hardship
exemption categories.
After publication of the CY 2011 PFS
Final Rule with comment period, we
received numerous requests to expand
the categories under the significant
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hardship exemption for the payment
adjustment. Some stakeholders
recommended specific circumstances of
significant hardship for our
consideration (for example, eligible
professionals who have prescribing
privileges but do not prescribe under
their NPI, eligible professionals who
prescribe a high volume of narcotics,
and eligible professionals who
electronically prescribe but typically do
not do so for any of the services
included in the electronic prescribing
measure’s denominator), while others
strongly suggested we consider
increasing the number of specific
hardship exemption categories. We
believe that many of the circumstances
raised by stakeholders may pose a
significant hardship and limit eligible
professionals and group practices in
their ability to meet the requirements for
being successful electronic prescribers
either because of the nature of their
practice or because of the limitations of
the electronic prescribing measure itself,
and as a result, such professionals might
be unfairly penalized. Therefore, in the
final rule entitled ‘‘Medicare Program;
Changes to the Electronic Prescribing
(eRx) Incentive Program’’ that was
published in the September 6, 2011
Federal Register, (76 FR 54963), we
expanded the categories under the
significant hardship exemption for the
2012 payment adjustment. Because we
believe the reasons why we expanded
the categories under the significant
hardship exemption for the 2012
payment adjustment also apply to the
2013 and 2014 payment adjustments,
we proposed (76 FR 42896) to retain the
following significant hardship
exemptions for the 2013 and 2014
payment adjustments:
• Inability to electronically prescribe
due to local, state, or Federal law or
regulation
• Eligible professionals who prescribe
fewer than 100 prescriptions during a 6month, payment adjustment reporting
period
(i) Inability to Electronically Prescribe
Due to Local, State, or Federal Law or
Regulation
We proposed (76 FR 42896–42897)
that, to the extent that local, State, or
Federal law or regulation limits or
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prevents an eligible professional or
group practice that otherwise has
general prescribing authority from
electronically prescribing (for example,
eligible professionals who prescribe a
large volume of narcotics, which may
not be electronically prescribed in some
states, or eligible professionals who
practice in a State that prohibits or
limits the transmission of electronic
prescriptions via a third party network
such as Surescripts), the eligible
professional or group practice would be
able to request consideration for an
exemption from application of the 2013
and/or 2014 payment adjustments,
which would be reviewed on a case-bycase basis. We believe eligible
professionals in this situation face a
significant hardship with regard to the
requirements for being successful
electronic prescribers because while
they may meet the 10 percent threshold
for applicability of the payment
adjustment, or the 100 denominatoreligible cases limit in a 6-month
payment adjustment reporting period,
they may not have sufficient
opportunities to meet the requirements
for being a successful electronic
prescriber because Federal, State, or
local law or regulation limit the number
of opportunities that an eligible
professional or group practice has to
electronically prescribe.
(ii) Eligible Professionals Who Prescribe
Fewer Than 100 Prescriptions During a
6-Month, Payment Adjustment
Reporting Period
We proposed (76 FR 42897) that an
eligible professional who has
prescribing privileges, but prescribes
fewer than 100 prescriptions during a 6month, payment adjustment reporting
period (for example, a nurse practitioner
who may not write prescriptions under
his or her own NPI, a physician who
decides to let his Drug Enforcement
Administration registration expire
during the reporting period without
renewing it, or, for purposes of the 2013
payment adjustment, an eligible
professional who prescribed fewer than
100 prescriptions between January 1,
2012 and June 30, 2012 regardless of
whether the prescriptions were
electronically prescribed or not), yet
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still meets the 10 percent threshold for
applicability of the payment adjustment,
would be able to request consideration
for a significant hardship exemption
from application of the 2013 and/or
2014 payment adjustment, which would
be reviewed on a case-by-case basis. We
believe that it is a significant hardship
for eligible professionals who have
prescribing privileges, but infrequently
prescribe, to become successful
electronic prescribers because the
nature of their practice may limit the
number of opportunities an eligible
professional or group practice to
prescribe, much less electronically
prescribe.
We invited public comments on our
proposal to modify 42 CFR 414.92 to
include the significant hardship
exemption categories we proposed for
the 2013 and 2014 payment
adjustments. The following is a
summary of the comments we received.
Comment: Several commenters
supported our proposed significant
hardship exemption categories. Some
commenters sought clarification on who
may apply for significant hardship
exemptions.
Response: We appreciate the
commenters’ feedback and are finalizing
the proposed significant hardship
exemption categories for the 2013 and
2014 payment adjustments. We have
provided examples of who may
potentially qualify for an exemption
under each finalized significant
hardship exemption category. However,
we note that the examples provided are
not exhaustive. Any eligible
professional who believes he or she
qualifies for an exemption under any of
the significant hardship exemption
categories may request consideration for
an exemption.
Comment: Some commenters
supported our specific proposal to adopt
the significant hardship exemption
category for eligible professionals who
are unable to electronically prescribe
due to local, State, or Federal law or
regulation for the 2013 and 2014
payment adjustments.
Response: We appreciate the
commenters’ support. Based on the
comments received and for the reasons
explained in our responses, we are
finalizing this significant hardship
exemption category.
Comment: One commenter asked
whether the significant hardship
exemption category for eligible
professionals who are unable to
electronically prescribe due to local,
State, or Federal law or regulation
applies to physicians who cannot
submit electronic prescriptions of
controlled substances because their
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vendor software is not yet compliant
with Federal and/or state requirement.
Response: We appreciate the
commenter’s question. Such a scenario
may or may not fall under this
particular significant hardship
exemption category. As we indicated,
this significant hardship exemption is
aimed at addressing instances where an
eligible professional would find it a
significant hardship to submit a
substantial portion of their prescriptions
electronically because local, State, or
Federal law or regulation limits or
prevents an eligible professional or
group practice that otherwise has
general prescribing authority from
electronically prescribing. Our analysis,
however, is fact-specific, so we would
need to look at the particular law, the
details about why the professional’s
vendor software is in ‘‘noncompliance’’, and the professional’s
particular circumstances to determine
whether a significant hardship exists
and an exemption can be granted under
this category. For example, we
understand that the Drug Enforcement
Agency (DEA) has proposed (75 FR
16236) but not yet finalized
requirements for the transmission of
electronic prescriptions of controlled
substances, and that system vendors are
awaiting these finalizing requirements
so that its electronic prescribing systems
may allow for the transmission of
electronic prescriptions of controlled
substances in a manner that is
compliant with current Federal law.
However, whether or not we would
grant a exemption under this significant
hardship exemption category would
depend on the amount of controlled
substances an eligible professional
prescribes relative to other
prescriptions. We also note that this
significant hardship exemption category
is not intended for eligible professionals
to refrain from updating their respective
electronic prescribing systems in order
to qualify for and exemption under this
significant hardship exemption
category.
Comment: Some commenters
specifically supported the proposed
significant hardship exemption category
for eligible professionals who prescribe
fewer than 100 prescriptions during a 6month, payment adjustment reporting
period.
Response: We appreciate the
commenters’ support and are finalizing
this significant hardship exemption
category for purposes of the 2013 and
2014 payment adjustment.
Comment: One commenter suggested
that we ensure that all physicians who
cannot or do not write prescriptions be
sufficiently accounted for in our
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proposed significant hardship
exemption categories.
Response: We respectfully disagree.
We believe the significant hardship
exemptions, as well as the limitations
we are finalizing for the 2013 and 2014
payment adjustments, adequately
encompass the scenarios in which it
would be a significant hardship to
comply with the criteria for being
successful electronic prescribers for the
2013 and/or 2014 payment adjustments.
Comment: Some commenters
recommended additional significant
hardship exemption categories to the
2013 and 2014 payment adjustments.
Specifically, commenters requested the
following be added as significant
hardship exemption categories for the
2013 and 2014 payment adjustments: (1)
Eligible professionals who are eligible
for Social Security benefits or nearing
retirement; (2) eligible professionals
who work solely within skilled nursing
facilities or hospital settings; (3) eligible
professionals who attempted to report
the electronic prescribing measure for
purposes of the 2013 and 2014 payment
adjustments but encountered problems
when reporting the electronic
prescribing measure; (4) eligible
professionals who elect not to purchase
an electronic prescribing system; and (5)
eligible professionals whose patients
prefer paper prescriptions.
Response: We appreciate the
commenters’ feedback but respectfully
disagree. With respect to eligible
professionals who are over 60, eligible
for social security benefits, or nearing
retirement; eligible professionals who
work solely in skilled nursing homes or
hospital settings; eligible professionals
who experienced system problems
when attempting to report the electronic
prescribing measure; eligible
professionals simply electing not to
purchase an electronic prescribing
system; or eligible professionals whose
patients prefer paper prescriptions, most
of these scenarios were raised by
commenters during the comment period
and addressed in the CY 2011 PFS final
rule, as well as the 2011 ‘‘Medicare
Program; Changes to the Electronic
Prescribing (eRx) Incentive Program’’
final rule. As we stated in the CY 2011
PFS final rule (75 FR 73564) and the
2011 eRx final rule (76 FR 54962), we
believe these instances do not constitute
significant hardships in the manner that
these significant hardship exemption
categories that we are finalizing do. We
believe that encouraging the use of
electronic prescribing outweighs the
cost of purchasing an electronic
prescribing system, because we believe
use of these systems will readily
provide patient prescription history
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leading to better management of patient
prescriptions and greater patient safety
and care.
Specifically, with respect to eligible
professionals who are over 60, eligible
for social security benefits, or nearing
retirement, we believe that these eligible
professionals still have the ability to use
electronic prescribing systems. With
respect to eligible professionals who
practice off-site, such as those practicing
in nursing homes, we note that although
these eligible professionals may not
readily have an electronic prescribing
system available, these eligible
professionals still have the ability to
provide an electronic prescription. With
respect to system errors, in general, we
understand that problems may occur
with regard to successful reporting of
the eRx measure. However, we do not
believe that such errors constitute a
significant hardship under section
1848(a)(5)(B) of the Act. Rather, these
are reporting errors that may have
prevented an eligible professional from
successfully reporting the eRx measure.
Comment: Commenters requested the
following as additional significant
hardship exemption categories for the
2013 and 2014 payment adjustments:
Eligible professionals who plan to adopt
EHR technology for purposes of
participating in the EHR Incentive
Program.
Response: With respect to providing a
significant hardship exemption for
eligible professionals planning to adopt
Certified EHR Technology to participate
in the EHR Incentive Program, we note
that we finalized such a significant
hardship exemption category for the
2012 payment adjustment because the
certification and listing of certified EHR
technologies (certified Complete EHRs
and certified EHR Modules) on the ONC
Certified HIT Products List (CHPL) did
not begin until September 2010 (76 FR
54957). As such, eligible professionals
may have delayed purchasing an EHR
system. This is no longer the case. The
list of Certified EHR Technology has
been available for over a year, and the
EHR Incentive Program has been
implemented. Therefore, we believe that
this significant hardship exemption
category is no longer applicable to the
2013 and 2014 payment adjustments.
Comment: Commenters requested the
following additional significant
hardship exemption categories for the
2013 and 2014 payment adjustments:
Eligible professionals who report the
electronic prescribing measure at least
10 times during CYs 2012 and 2013 for
the 2013 and 2014 respective payment
adjustments, but did not do so during
the first 6-months of 2012 and 2013.
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Response: We disagree with
commenters suggestion for this
significant exemption hardship
category, because it would be contrary
to the reporting periods we are
finalizing for the 2013 and 2014
payment adjustments.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing the following
significant hardship exemption
categories for the 2013 and 2014
payment adjustments, which will be
reflected under 42 CFR 414.92:
• The eligible professional or group
practice practices in a rural area with
limited high speed internet access.
• The eligible professional or group
practice practices in an area with
limited available pharmacies for
electronic prescribing.
• Inability to electronically prescribe
due to local, state, or Federal law or
regulation.
• Eligible professionals who prescribe
fewer than 100 prescriptions during a
6-month, payment adjustment reporting
period.
(B) Process for Submitting Significant
Hardship Exemptions—Individual
Eligible Professionals and Group
Practices
To request a significant hardship
exemption for any of the proposed
categories, we proposed (76 FR 42897)
that an eligible professional provide to
us by the end of the 2013 and/or 2014
payment adjustment reporting periods
(that is June 30, 2012 for the 2013
payment adjustment and June 30, 2013
for the 2014 payment adjustment), the
following:
• The name of the practice and other
identifying information (for example:
TIN, NPI, mailing address, and email
address of all affected eligible
professionals.
• The significant hardship exemption
category(ies) that apply.
• A justification statement describing
how compliance with the requirement
for being a successful electronic
prescriber for the respective 2013 and/
or 2014 payment adjustment during the
reporting period would result in a
significant hardship to the eligible
professional. And that the justification
statement be specific as to the category
under which the eligible professional or
group practice is submitting its request
and include an explanation how the
exemption applies.
• An attestation of the accuracy of the
information provided.
We also proposed that eligible
professionals or group practices would
be required, upon request, to provide
additional supporting documentation if
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73415
there is insufficient information to
justify the request or make the
determination whether a significant
hardship exists.
We also proposed that eligible
professionals or group practices would
be able to submit significant hardship
exemption requests using the web-based
tool or interface (that we are also using
for requests for exemptions due to
significant hardships for the 2012
payment adjustment). We proposed that
the following two hardships also be
reportable by G-code on claims in
addition to using the web-based tool or
interface:
• The eligible professional or group
practice practices in a rural area with
limited high speed internet access
(report G-code G9642).
• The eligible professional or group
practice practices in an area with
limited available pharmacies for
electronic prescribing (report G-code
G8643).
We also proposed that once we have
completed our review of the eligible
professional’s or group practice’s
request and made a decision, we will
notify the eligible professional or group
practice of our decision and all such
decisions would be final. Eligible
professionals or group practices will not
have the opportunity to request
reconsiderations of their requests for
significant hardship exemption. We
invited public comment on the
proposed process for individual eligible
professionals and group practices for
submitting these requests for significant
hardship exemptions to us (including
comments on the type of information we
proposed eligible professionals must
submit, the proposed options for how
the information could be submitted, and
the proposed timeframes for
submission). The following is a
summary of the comments received
related to our proposed process for
submitting requests for significant
hardship exemptions.
Comment: Some commenters support
the use of a web-based tool whereby
eligible professionals and group
practices may submit requests for
significant hardship exemptions.
Response: We appreciate the
commenter’s feedback and are finalizing
our proposal to allow for use of a webbased tool to submit requests for
significant hardship exemption
requests. Eligible professionals wishing
to request a significant hardship
exemption to the 2013 and 2014
payment adjustments may do so through
the Communications Support Page,
available at https://www.qualitynet.org/
portal/server.pt/community/
communications_support_system/234.
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Comment: One commenter urged us
to allow for the submission of
significant hardship requests via other
methods aside from a web-based tool,
such as via telephone, because eligible
professionals requesting significant
hardship exemptions may not have
access to the internet.
Response: We appreciate the
commenter’s feedback. However, we
believe that the web-based tool provides
the most efficient method of submitting
a significant hardship request. In
limited instances where eligible
professionals may not be able to submit
a significant hardship request via the
web-based tool due to lack of internet
access, eligible professionals may call
the QualityNet Help Desk for assistance
on requesting a hardship.
Comment: One commenter suggested
that, although eligible professionals
need only request one significant
hardship exemption, eligible
professionals may apply for more than
one significant hardship exemption
request if more than one category
applies.
Response: If an eligible professional
believes that more than one significant
hardship exemption category applies to
his/her practice, s/he must request a
significant hardship exemption under at
least one significant hardship
exemption category. However, the
eligible professional may indicate that
more than one significant hardship
exemption category applies to his or her
practice in the eligible professional’s
justification statement.
Comment: A few commenters
suggested that we extend the deadline to
submit significant hardship exemptions
for purposes of the 2013 and 2014
payment adjustment, noting that we
provided an extended deadline to
submit significant hardship exemption
requests for purposes of the 2012
payment adjustment.
Response: We did finalize an
extended deadline of November 1, 2011
to submit requests for significant
hardship exemptions for the 2012
payment adjustment (76 FR 54964). We
note, however, that the extension of the
deadline for submitting requests for
significant hardship exemptions for the
2012 payment adjustment was a unique
situation, as new significant hardship
exemption categories were finalized
after the publication of the 2011 PFS
Final Rule. However, we also noted that,
due to the deadline extension, we may
have to reprocess claims in instances
where significant hardship requests
were not reviewed in time. We believe
that the deadlines we proposed for
submitting requests for significant
hardship exemptions for the 2013 and
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2014 payment adjustments (that is, June
30, 2012 and June 30, 2013 respectively)
provide eligible professionals with
ample time to submit requests for
significant hardship exemptions.
Therefore, we are finalizing our
proposed deadlines for submitting
requests for significant hardship
exemptions from the 2013 and 2014
payment adjustments. We note that,
although we are making every attempt
to do so, there is a possibility we may
not have the Communications Support
Page available for submitting requests
for significant hardship exemptions by
January 1, 2012. We do not expect that
such a delay would adversely affect
eligible professionals because, although
eligible professionals may need time to
prepare and develop its request (and
that time remains unchanged), the time
needed to actually submit the request
through the Web page should not take
a substantial amount of time (that is, we
would not expect that it would take an
eligible professional 6 months to do a
single web-based submission). We
recognize, however, that eligible
professionals may not want to be
limited with regard to the particular
day(s) it submits its request before the
deadline. Therefore, in the event there
is a delay in making the Communication
Support Page available for submitting
requests for significant hardship
exemptions, we may extend the
deadline for submitting requests for
significant hardship exemptions for the
2013 payment adjustment.
Based on the comments received and
for the reasons stated previously, we are
finalizing the following process for
submitting a request for a significant
hardship exemption under the
significant hardship exemption
categories we are finalizing for the 2013
and 2014 payment adjustments.
Eligible professionals and group
practices may report the following
G-codes for the following significant
hardship exemption categories on
claims for services rendered during the
respective 2013 and 2014 6-month
reporting periods.
• The eligible professional or group
practice practices in a rural area with
limited high speed internet access
(report G-code G9642).
• The eligible professional or group
practice practices in an area with
limited available pharmacies for
electronic prescribing (report G-code
G8643).
Eligible professionals may submit
requests for a significant hardship
exemption category with respect to any
of the finalized significant hardship
exemption categories via a web-based
tool, the Communication Support Page,
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which is available at https://
www.qualitynet.org/portal/server.pt/
community/
communications_support_system/234.
More information on this web-based
tool is available on our Web site at
https://www.cms.gov/ERXincentive/. To
request a significant hardship
exemption via the web-based tool for
any of the categories we are finalizing,
including a request under the two
significant hardship exemptions
categories that are also reportable via
G-code, an eligible professional must
provide to us by June 30, 2012 for the
2013 payment adjustment and June 30,
2013 for the 2014 payment adjustment,
the following—
• The name of the practice and other
identifying information (for example:
TIN, individual NPI, mailing address,
and email address of all affected eligible
professionals;
• The significant hardship exemption
category(ies) that apply;
• A justification statement describing
how compliance with the requirement
for being a successful electronic
prescriber for the respective 2013
and/or 2014 payment adjustment during
the reporting period would result in a
significant hardship to the eligible
professional; and
• An attestation of the accuracy of the
information provided—
++ The justification statement should
be specific to the category under which
the eligible professional or group
practice is submitting its request and
must explain how the exemption
applies to the professional. For example,
if the eligible professional is requesting
a significant hardship exemption due to
Federal, State, or local law or regulation,
he or she must cite the applicable law
and how the law restricts the eligible
professional’s ability to electronically
prescribe. We will review the
information submitted by each eligible
professional on a case-by-case basis. In
addition, an eligible professional or
group practice must, upon request,
provide additional supporting
documentation if there is insufficient
information (such as, but not limited to,
a TIN or NPI that we cannot match to
the Medicare claims, a certification
number for the Certified EHR
Technology that does not appear on the
list of Certified EHR Technology, or an
incomplete justification for the
significant hardship exemption request)
to justify the request or make the
determination of whether a significant
hardship exists.
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G. Physician Compare Web Site
1. Background and Statutory Authority
Section 10331(a)(1) of the Affordable
Care Act (42 U.S.C. 1395w–5 note)
requires that, by no later than January 1,
2011, we develop a Physician Compare
Internet Web site with information on
physicians enrolled in the Medicare
program under section 1866(j) of the Act
as well as information on other eligible
professionals who participate in the
Physician Quality Reporting System
under section 1848 of the Act (42 U.S.C.
1395w–4). Public reporting of
performance results on standardized
quality measures currently exists on
https://www.medicare.gov for the
following:
• Hospitals (Hospital Compare).
• Dialysis facilities (Dialysis Facility
Compare).
• Nursing homes (Nursing Home
Compare).
• Home health facilities (Home
Health Compare).
As an initial step towards providing
information on the quality of care for
services furnished by physicians and
other professionals to Medicare
beneficiaries, we have enhanced the
existing Physician and Other Health
Care Professionals directory at https://
www.medicare.gov to develop a similar
Compare Web site specific to physicians
and other professionals. In accordance
with section 10331 of the Affordable
Care Act, we launched the first phase of
the Physician Compare Internet Web
site on December 30, 2010. This initial
phase included the posting of the names
of eligible professionals that
satisfactorily submitted quality data for
the 2009 Physician Quality Reporting
System.
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2. Final Plans
Section 10331(a)(2) of the Affordable
Care Act also requires that, no later than
January 1, 2013, and with respect to
reporting periods that begin no earlier
than January 1, 2012, we implement a
plan for making information on
physician performance publicly
available through the Physician
Compare Web site. 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.
• An assessment of patient health
outcomes and functional status of
patients.
• An assessment of the continuity
and coordination of care and care
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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 publically reported to have a
reasonable opportunity, as determined
by the Secretary, to review their results
before posting to Physician Compare.
• 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 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 in
selecting quality measures for Physician
Compare. In developing the plan for
making information on physician
performance publicly available through
the Physician Compare Web site, section
10331(e) of the Affordable Care Act
requires the Secretary, as the Secretary
deems 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 Medicare Improvements for
Patients and Providers Act of 2008.
We are required, under section
10331(f) of the Affordable Care Act, to
submit a report to the Congress by
January 1, 2015 on the Physician
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Compare Web site developed, 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 to foster transparency
and public reporting by providing
consumers with quality of care
information to make informed decisions
about their health care, while
encouraging clinicians to improve on
the quality of care they provide to their
patients. In accordance with section
10331 of the Affordable Care Act, we
intend to utilize the Physician Compare
Web site to publicly report physician
performance results.
For purposes of implementing a plan
to publicly report physician
performance, we plan to use data
reported under the existing Physician
Quality Reporting System as an initial
step for making public physician
‘‘measure performance’’ information on
Physician Compare. By ‘‘measure
performance,’’ we mean the percent of
times that a particular clinical quality
action was reported as being performed,
or a particular outcome was attained, for
the applicable persons to whom a
measure applies as described in the
denominator for the measure.
The Physician Quality Reporting
System is a readily available source of
measures performance data. First
implemented in 2007, the program has
grown to include over 200 measures (see
tables 47 through 72 in section VI.F.1.f.
of this final rule with comment period
for a list of the measures available for
reporting in 2012). The measures used
in the Physician Quality Reporting
System cover a wide range of health
conditions and topics and include
measures applicable to most physician
specialties and other clinicians. Work is
underway to ensure consistency of
quality measures reported under the
Physician Quality Reporting System and
the EHR Incentive Program.
The first phase of the plan to make
information on physicians and other
eligible professionals who participate in
the Physician Quality Reporting System
publically available was completed
through the launch of the Physician
Compare Web site and the posting of the
names of those eligible professionals
who satisfactorily participated in the
Physician Quality Reporting System.
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During the second phase of the plan,
occurring in 2011 through 2012, we will
continue to work towards the
development and improvement of the
Web site. Our plans for Physician
Compare Web site development during
this second phase include monthly data
refreshes and a semiannual Web site
release to incorporate updates and
improvements to the Web site. Updates
will include the addition of the names
of eligible professionals who are
successful electronic prescribers, as
required by section 1848(m)(5)(G) of the
Act, as well as the names of those
eligible professionals who participate in
the EHR Incentive Program, as required
by section 1848(o)(3)(D) of the Act.
Additional enhancements planned
include the addition of links to specialty
board Web sites that can provide more
information on an eligible professional’s
board certification status and improved
Web site functionality and layout.
Moving towards the reporting of
physician performance information, we
proposed to take an initial step by
making public the performance rates of
the quality measures that group
practices submit under the 2012
Physician Quality Reporting System
group practice reporting option (GPRO)
(76 FR 42899). We also proposed to
publicly report the performance rates of
the quality measures that the group
practices participating in the Physician
Group Practice demonstration report on
the Physician Compare Web site as early
as 2013 for performance information
collected in CY 2012. We would make
public the measure performance for
each of the measures included in the
2012 Physician Quality Reporting
System GPRO. Since the quality
measures in GPRO are reported for the
group as a whole, the information on
measure performance would also apply
to the group as a whole, rather than to
individual physicians within a group.
Public reporting of the group
practices’ 2012 measure performance
results at the group practice level would
begin public reporting at the earliest
time specified by the statute. We believe
the design of the GPRO (see section
VI.F.b.2. of this final rule with comment
pe) facilitates making public groups’
performance results. All groups
participating in the GPRO would be
reporting on the same set of clinical
quality measures, which allows for
comparison of the results across groups.
To eliminate the risk of calculating
performance rates based on a small
denominator, we proposed to set a
minimum patient sample size threshold
(76 FR 42899). A minimum threshold of
25 patients would have to be met in
order for the group practice’s measure
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performance rate to be reported on the
Physician Compare Web site. If the
threshold of 25 patients is not met for
a particular measure, the group’s
performance rate for that measure
would be suppressed and not publicly
reported. In determining the minimum
patient sample size, we took into
consideration the minimum patient
sample size used by other Compare Web
sites that publicly report measure
performance data. We wanted to ensure
that we used a number large enough to
accurately reflect measure performance,
but not so large that it would limit the
number of groups for which measure
performance could be reported. In
taking into consideration the minimum
patient sample size used by other
Compare Web sites that publicly report
measure performance data, we also
considered a minimum patient sample
size of 10 patients, 20 patients and 30
patients. As we are proposing to report
measure performance at a group level
and a majority of the other Compare
Web sites use minimum sample sizes of
between 20 and 30 patients, we
concluded that a minimum patient
sample size of 25 would meet our
criteria (76 FR 42899).
We also proposed that group practices
participating in the 2012 Physician
Quality Reporting System GPRO would
agree in advance to have their reporting
performance results publicly reported as
part of their self-nomination to
participate in the 2012 Physician
Quality Reporting System GPRO.
Finally, we proposed to modify the
GPRO web interface for 2012 to
calculate the numerator, denominator,
and measure performance rate for each
measure from the data that the group
practices use to populate the tool and
provide each group practice this
information at the time of data
submission. This feature would allow
the group practice the opportunity to
review their measure performance
results before they are made public in
accordance with section 10331(b) of the
Affordable Care Act. For groups
reporting using GPRO information that
is made public in 2013, we did not
propose to post information with
respect to the measure performance of
individual physicians or eligible
professionals associated with the group.
However, we proposed to identify the
individual eligible professionals who
were associated with the group during
the reporting period.
We believe a staged approach to
public reporting of physician
information allows for the use of
information currently available while
we develop the infrastructure necessary
to support the collection of additional
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types of measures and public reporting
of individual physicians’ quality
measure performance results.
Implementation of subsequent phases of
the plan will need to be developed and
addressed in future notice and comment
rulemaking, as needed. We invited
comments regarding our proposals to:
(1) To publicly report group practices’
measure performance results in 2013
based on group practices’ 2012
Physician Quality Reporting System
performance results under GPRO; and
(2) utilize a minimum patient sample
size of 25 for reporting and displaying
measure performance on the Physician
Compare Web site.
We received several comments from
the public on the CY 2012 PFS proposed
rule related to the Physician Compare
Web site. General comments about the
Physician Compare Web site are
addressed as follows.
Comment: CMS received positive
feedback supporting our staged
approach to developing the Physician
Compare Web site, including
improvements planned for our second
phase development and public reporting
of physician information and
performance.
Response: We appreciate the
commenters’ positive feedback. We
believe a staged approach to the Web
site development and public reporting
of physician information and
performance will allow us to use the
information currently available while
we continue to work towards
improvement of the Web site and
develop the infrastructure necessary to
support the collection of additional
types of information and measures.
Comment: CMS received several
comments expressing concerns over the
accuracy of the physician information
currently being displayed on the
Physician Compare Web site.
Specifically, the comments mentioned
inaccuracies around basic physician
information, specialties, licensure, and
practice location/affiliation.
Commenters urged CMS to validate the
accuracy of successful participation in
the various CMS quality measure
reporting programs.
Response: We appreciate the
commenters’ feedback. We are
committed to including accurate and
up-to-date provider information on the
Physician Compare Web site and
continue to work towards the necessary
steps to make improvements. We look
forward to engaging the provider
community toward that end. The
provider information used to populate
the Physician Compare Web site comes
from the Provider Enrollment, Chain,
and Ownership System (PECOS) and an
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external data source. In order for a
physician or other health care
professional’s information to appear on
the Physician Compare Web site, their
enrollment record in PECOS must be
current and in ‘‘approved’’ status, a
valid physical location or address must
be identified and the provider must
have a valid State license and NPI.
There is a 45–60 day lag for new
enrollment, updates, and changes to
take place in PECOS. Currently,
physicians and eligible professionals
can find instructions on how to update
and correct their information on the
Physician Compare Web site under the
‘‘Note to Provider’’ section located on
the ‘‘About the Data’’ page. In general,
most updates or corrections to provider
information can be made through
PECOS, either via Internet-based PECOS
or a paper process. Corrections can also
be requested through the Web site’s
feedback tool function.
Comment: CMS also received several
comments expressing concern around
the eventual reporting of measures
performance on the Physician Compare
Web site. These comments included
general concerns about the accuracy of
the data to be reported, as well as
specific concerns regarding the lack of
measures available to assess safety,
effectiveness and timeliness of care, and
continuity and coordination of care.
Several comments stated that CMS must
ensure that measure performance data is
properly attributed to the correct
provider or practice and that data is risk
adjusted.
Response: We appreciate the
commenters’ feedback. As required
under section 10331(b) of the Affordable
Care Act, in developing and
implementing the plan to include
performance data on Physician
Compare, we must include, to the extent
practicable, processes to ensure that
data made public are statistically valid,
reliable, and accurate, including risk
adjustment mechanisms used by the
Secretary, as well as processes to ensure
appropriate attribution of care when
multiple and other providers are
involved in the care of the patient. We
are committed to working towards
reported measures that are accurate and
complete.
Comment: Several commenters urged
CMS to provide a specific mechanism
whereby providers can report and
correct data errors. Many commenters
suggested that a 30-day timeframe to
correct errors should be implemented by
CMS.
Response: We appreciate the
commenters’ feedback. Through regular
data refreshes, CMS is working toward
more accurate and up-to-date
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information on Physician Compare. We
intend to conduct monthly refreshes
and semi-annual updates as technically
feasible. We look forward to engaging
with providers and stakeholders to
further address these concerns.
Comment: CMS received comments
urging CMS to develop appropriate
disclaimer language to note potential
issues with accuracy and to avoid any
misinterpretation of data. Many of the
comments requested that CMS work
with the provider community to
develop disclaimers and one comment
suggested the use of a ‘‘splash page’’
whereby Web site users would have to
read the disclaimer and ‘‘accept’’ before
seeing the data.
Response: We appreciate the
commenters’ feedback. We look forward
to the opportunity to work with
providers and external stakeholders and
discuss options for presenting
performance information in a way that
is accurate and understood by
consumers. CMS will take the idea of
creating a disclaimer ‘‘splash page’’ into
consideration. Currently, the Physician
Compare Web site has disclaimer
language to explain that the Physician
Quality Reporting System is a voluntary
program. The disclaimer includes some
of the numerous reasons why
physicians or other healthcare
professionals, who are committed to
providing high quality care to their
patients, may have chosen not to report
quality information under the Physician
Quality Reporting System.
Comment: One commenter expressed
concern over whether a psychiatrist’s
performance can ever be accurately
reflected on Physician Compare because
many of the measure categories
prescribed by the Affordable Care Act
(i.e., patient health outcomes and
functional status, continuity and
coordination of care and care
transitions, patient experience and
patient, caregiver, and family
engagement, etc.) fail to account for
environmental factors affecting patient
outcomes.
Response: We appreciate the
commenter’s feedback. CMS is
committed to working with providers
and external stakeholders toward the
aim of presenting accurate performance
data on Physician Compare, and the
various specialties represented therein.
CMS recognizes that measures around
patient outcomes, patient experience,
etc. are inherently dependent on patient
factors and this is not unique to
psychiatry. As required under section
10331(b) of the Affordable Care Act, in
developing and implementing the plan
to include performance data on
Physician Compare, we must include, to
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the extent practicable, processes to
ensure that data made public are
statistically valid, reliable, and accurate,
including risk adjustment mechanisms
used by the Secretary. As such, CMS
will need to account for patient factors
affecting patient outcomes through riskadjustment, exclusions, and/or
appropriate disclaimer language to
explain how patient factors beyond the
control of the physician or other eligible
professional can affect patient
outcomes.
Comment: One commenter urged
CMS to assure that the physician
information provided to the public on
the Physician Compare Web site is
based on quality data and not cost and
claims data.
Response: We appreciate the
commenters’ feedback. As we proposed
in the proposed rule (76 FR 42899) and
are finalizing below, CMS will only
publicly report group practices’ measure
performance results in 2013 based on
group practices’ 2012 Physician Quality
Reporting System performance results
under GPRO at this time. We did not
propose to make cost and claims data
public.
Comment: One commenter stated that
implementation of the Physician
Compare Web site is intertwined with
Section 3003 of the Affordable Care Act,
which requires Medicare to
confidentially report both quality and
cost data to individual physicians and
groups. The commenter expressed
concerns over the public reporting of
‘‘confidential’’ data and urged CMS to
clarify what, if any, ‘‘confidential’’
information it plans to make available to
the public.
Response: We appreciate the
commenters’ feedback. The Physician
Compare Web site is mandated by
section 10331 of the Affordable Care
Act, which authorizes CMS to publicly
report information on physician
performance. Section 3003 of the
Affordable Care Act amends a separate
program, the Physician Feedback
Program. While these two sections both
address quality data, section 10331 does
not classify the quality data as
‘‘confidential.’’ In this final rule, we are
finalizing our proposal to publicly
report group practices’ measure
performance results in 2013 based on
group practices’ 2012 Physician Quality
Reporting System performance results
under GPRO. Section 10331 of the
Affordable Care Act also requires CMS
to include, to the extent practicable,
measures collected under the Physician
Quality Reporting System. Based on
established CMS data security
procedures and as otherwise required by
law, all patient data will be confidential
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and protected. Therefore, on the
Physician Compare Web site, patient
data will be aggregated and no patient
identifiers will be made public.
Comment: One commenter urged
CMS to develop public reporting
formats that are consistent with
established public reporting formats
(that is, Consumer Union).
Response: We appreciate the
commenters’ feedback. We will take into
consideration the idea of using a data
report format for Physician Compare
consistent with established formats, as
feasible. We look forward to engaging
providers, stakeholders, and consumers
in further considering this issue.
Comment: One commenter expressed
that they would like to review how CMS
intends to integrate data from other
payers.
Response: We appreciate the
commenters’ feedback. In this final rule,
we are finalizing our proposal to only
publicly report group practices’ measure
performance results in 2013 based on
group practices’ 2012 Physician Quality
Reporting System performance results
under GPRO. The Physician Quality
Reporting System only utilizes Medicare
Part B data. Implementation of
subsequent plans for reporting quality
data, including any plan to utilize data
from other payers, will need to be
developed and addressed in future
notice and comment rulemaking, as
needed.
Comment: We received comments
suggesting that National Committee for
Quality Assurance recognition
information and participation
information in other established,
medical society-driven educational and
voluntary quality of care initiatives be
included on the Physician Compare
Web site.
Response: We appreciate the
commenter’s feedback. We will take into
consideration incorporating recognition
and participation in other established,
medical society-driven educational and
voluntary quality of care initiatives
information on Physician Compare.
Currently, the Physician Compare Web
site includes on the names of those
physicians and other eligible
professionals who satisfactorily report
data under the Physician Quality
Reporting System, as well as the names
of those professionals who are
successful electronic prescribers under
the Electronic Prescribing (eRx)
Incentive Program. Section
1848(o)(3)(D) of the HITECH Act
requires the Secretary to list in an easily
understandable format the names,
business addresses, and business phone
numbers of the Medicare EPs and, as
determined appropriate by the
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Secretary, of group practices receiving
incentive payments for being
meaningful EHR users under the
Medicare FFS program on our Internet
Web site. As such, we plan to add
information for Medicare eligible
professionals who received incentive
payments for being meaningful EHR
users under the Medicare FFS program
in 2012.
Comment: CMS received a number of
comments expressing concern over how
hospital related data will be
incorporated on the Physician Compare
Web site. Specifically, commenters were
concerned about reporting performance
for physicians who treat hospital
inpatients and the lack of performance
measures within the Physician Quality
Reporting System appropriate for the
hospital setting. Commenters urged
CMS to make hospital affiliation
information available on Physician
Compare.
Response: We appreciate the
commenters’ feedback. We agree that
illustrating hospital and physician
integration and alignment is important.
We will take into consideration the
potential option of incorporating
hospital affiliation information on
Physician Compare.
Comment: CMS received comments
requesting us to clarify how the group
practice data displayed on Physician
Compare will reflect the performance of
eligible professionals who are employed
in hospitals and health systems, how
physician-to-group attribution will be
managed and how both provider-level
and group-level will reside on the same
Web site.
Response: We appreciate the
commenter’s feedback. In this final rule,
we are finalizing our proposal to
publicly report group practices’ measure
performance results in 2013 based on
group practices’ 2012 Physician Quality
Reporting System performance results
under GPRO as an initial step towards
public reporting of physician
performance. We believe that reporting
at the group practice level will reflect
the performance of the group practice or
health system as a whole. We believe
reporting at the group level encourages
the group’s shared responsibility for
patient health outcomes and care
coordination. While we intend to
identify those eligible professionals who
have assigned their Medicare Part B
billing rights to the group practice’s tax
identification number, performance
rates will not be displayed on the
individual eligible professionals’ profile
on Physician Compare in 2013.
Implementation of subsequent plans for
reporting physician performance will
need to be developed and addressed in
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future notice and comment rulemaking,
as needed.
Comment: CMS received several
comments urging CMS to ensure that
the Physician Compare Web site is userfriendly and that the public can
understand the data being reporting.
Specifically, commenters stressed the
importance of provider input on the
design and content of the Web site and
that CMS implement a public education
program to help users understand the
data and use information properly.
Response: We appreciate the
commenters’ feedback. We will consider
engaging providers and external
stakeholders, as well as consumers, to
provide input into the design and
content of Physician Compare.
Comment: We received several
comments about the data review period
and appeal process for performance
measures reported on the Physician
Compare Web site. Specifically, one
commenter urged CMS to clarify the
review process for group practices and
one requested that group practices
should have the opportunity to review
comparative benchmark data, before
data is publicly reported. Other
commenters urged CMS to provide
physicians with an opportunity to
review their data and allow physicians
to request corrections to the data.
Commenters recommended at least a 60day to 6-month time period be provided
for physicians to review the data before
it is made public on Physician Compare.
Response: We appreciate the
commenters’ feedback. Section 10331(b)
of the Affordable Care Act requires CMS
to establish processes for physicians and
eligible professionals whose information
is being publically reported to have a
reasonable opportunity, as determined
by the Secretary, to review their results
before posting to Physician Compare. In
this final rule, we are finalizing our
proposal to publicly report group
practices’ measure performance results
in 2013 based on group practices’ 2012
Physician Quality Reporting System
performance results under GPRO as an
initial step towards public reporting of
physician performance. We are also
finalizing our proposal to modify the
group practice data collection tool or
‘‘GPRO Web Interface’’. The GPRO web
interface will calculate and display the
denominator, numerator and measure
performance rate for each measure from
the data that the group practice uses to
populate the GPRO web interface. This
feature will allow the group practice to
review its measure performance prior to
posting on the Physician Compare Web
site. Group practices participating in
GPRO currently receive comparative
benchmark data in their feedback
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reports and they will continue to receive
comparative benchmark data. CMS will
take into consideration the suggested
time period for reviewing data and will
address in future rulemaking.
Comment: Commenters expressed
concern that the specialty list on
Physician Compare is inaccurate or
incomplete.
Response: We appreciate the
commenters’ feedback. We are
committed to including accurate and
complete information for all specialties
on the Physician Compare web site. We
look forward to engaging the provider
community toward that end.
Comment: CMS received comments
supporting the inclusion of physician
board certification information on
Physician Compare. Commenters
stressed the importance of
distinguishing between credible
certification bodies and other
organizations, as well as including
accurate information that is not reliant
on self-reported data. Commenters
support a link from the Physician
Compare site to other Web sites with
board certification information until a
data sharing agreement that would
allow board certification information
directly on the Physician Compare Web
site can be finalized.
Response: We appreciate the
commenters’ feedback and support. We
agree that board certification is valuable
information for consumers and
therefore, we are exploring the
possibility of, and our options for,
including board certification
information on the Physician Compare
web site (e.g., through links to other
Web sites; through data sharing, which
would allow the information to be
integrated with the Physician Compare
Web site and displayed directly on the
provider’s profile page).
Comment: One commenter advocated
that CMS customize the Physician
Compare Web site content to educate
users on the growing specialty of
hospital medicine. The commenter
suggested a link to the Hospital
Compare Web site for those physicians
in the hospital medicine specialty as
quality in this specialty is tied to
hospital quality.
Response: We appreciate the
commenters’ feedback. We are
committed to working with providers
and external stakeholders so that
beneficiaries have the information
necessary to be informed users of the
Physician Compare web site. We will
consider linking from Physician
Compare to Hospital Compare as
appropriate.
Comment: CMS received one
comment supporting the reporting of
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group level performance on Physician
Compare. The commenter believes that
group practices will have a sufficient
volume of patients to facilitate
comparisons and it would be easier for
groups to report on a core set of
measures.
Response: We appreciate the
commenters’ feedback and support. As
we indicated, in this final rule we are
finalizing our proposal to publicly
report Physician Compare group
practices’ measure performance results
in 2013 based on group practices’ 2012
Physician Quality Reporting System
performance results under GPRO.
Comment: Multiple commenters
expressed concern about the feasibility
of reporting individual level
performance on Physician Compare.
Specifically, commenters mentioned
inadequate sample size to make valid
comparisons across eligible
professionals, problems with attribution
and the risk for patient de-selection by
providers seeking to improve their
measure performance.
Response: We appreciate the
commenters’ feedback. In this final rule
with comment period, we are only
taking the initial step of reporting
physician performance data by publicly
reporting group practices’ measure
performance results in 2013 based on
group practices’ 2012 Physician Quality
Reporting System performance results
under GPRO. We believe that additional
time is needed to develop the
infrastructure necessary to support the
collection of additional types of
measures and public reporting of
individual physicians’ quality measure
performance results.
Comment: CMS received multiple
comments urging CMS to take the
necessary steps to enable reporting
reliable comparative information at the
individual provider level as soon as
possible.
Response: We appreciate the
commenters’ feedback. As stated
previously, we believe that additional
time is needed to develop the
infrastructure necessary to support the
collection of additional types of
measures and public reporting of
individual physicians’ quality measure
performance results. We will continue
to assess the feasibility of individual
level reporting. The implementation of
subsequent plans for reporting
physician performance will need to be
developed and addressed in future
notice and comment rulemaking, as
needed.
Comment: CMS received one
comment urging CMS to populate
Physician Compare with a core set of
measures that are meaningful to
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73421
patients. The commenter stated that the
core set should include cross-cutting
measures applicable to any physician as
well as measures that apply to specific
subsets of physicians. It was
emphasized that patient experience,
care coordination, functional status and
other outcome measures should be the
basis for the initial set of core measures.
Response: We appreciate the
commenters’ feedback. With regard to
our final decision to publicly report
group practices’ measure performance
results in 2013 based on group
practices’ 2012 Physician Quality
Reporting System performance results
under GPRO, all groups participating in
GPRO would be reporting on the same
set of clinical quality measures. The
implementation of subsequent plans for
reporting physician performance will
need to be developed and addressed in
future notice and comment rulemaking,
as needed.
Comment: One commenter supported
our proposal to use a minimum sample
size of 25 patients for a measure to be
reported on Physician Compare.
Another commenter expressed concern
over the minimum sample size of 25
patients. The commenter stated that 25
patients within a group practice for any
specific measure is not an adequate
representation of the practice’s
performance and is too small to enable
consumers to see meaningful differences
in provider performance.
Response: We appreciate the
commenters’ feedback. A majority of the
other Compare Web sites use minimum
sample sizes of between 20 and 30
patients and we concluded that a
minimum patient sample size of 25
would meet our need for a number large
enough to reflect measure performance,
but not so large as to limit the number
of groups for which measure
performance can be reported.
Upon consideration of the comments
and for the reasons we previously
explained, we are finalizing our
proposal to publicly report group
practices’ measure performance results
in 2013 based on group practices’ 2012
Physician Quality Reporting System
performance results under GPRO. We
are finalizing our proposal to use a
minimum sample size of 25 patients for
reporting and displaying measure
performance on the Physician Compare
Web site. Group practices participating
in 2012 Physician Quality Reporting
System GPRO must agree in advance to
have their reporting performance results
publicly reported as part of their selfnomination to participate in the 2012
Physician Quality Reporting System
GPRO. We are also finalizing our
proposal to modify the GPRO web
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interface for 2012 to calculate the
numerator, denominator and measure
performance rate for each measure from
the data that the group practices use to
populate the web interface. This
modification will allow the group
practice the opportunity to preview
their measure performance results
before they are made public in 2013. In
addition, as we discussed in the
Medicare Shared Savings Program
(MSSP) final rule, which displayed at
the Federal Register on October 20,
2011, https://www.ofr.gov/OFRUpload/
OFRData/2011-27461_PI.pdf, because
Accountable Care Organizations (ACO)
will be considered to be group practices
under the Physician Quality Reporting
System GPRO under the Shared Savings
Program, we believe ACO performance
on the quality measures reported using
the GPRO web interface should be
reported on Physician Compare in the
same way that we are reporting on the
performance of other group practices
that participate in the Physician Quality
Reporting System GPRO. Therefore,
performance data on quality measures
reported on by ACOs on behalf of its
eligible professionals in group practices
using the GPRO web interface will also
be reported on the Physician Compare
Web site in the same way as for the
group practices that report under the
Physician Quality Reporting System as
discussed in this section.
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H. Medicare EHR Incentive Program for
Eligible Professionals for the 2012
Payment Year
1. Background
We proposed (76 FR 42899) changes
to the method by which eligible
professionals (EPs) would report clinical
quality measures (CQMs) for the 2012
payment year for the Medicare EHR
Incentive Program. Specifically, we
proposed (76 FR 42900) that eligible
professionals may satisfy the
meaningful use objective to report
CQMs to CMS by reporting them
through: (1) Attestation; or
(2)participation in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot. We received some
comments that were not related to our
proposals for the Medicare EHR
Incentive Program for payment year
2012. While we appreciate the
commenters’ feedback, these comments
are outside the scope of the issues
addressed in this final rule.
2. Attestation
We proposed (76 FR 42900) that for
the 2012 payment year, EPs may
continue to report CQM results as
calculated by Certified EHR Technology
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by attestation, as for the 2011 payment
year.
Comment: Several commenters
supported our proposal to continue
reporting CQM results as calculated by
Certified EHR Technology by attestation
for the 2012 payment year.
Response: We appreciate the
commenters’ support and are finalizing
our proposal to allow EPs to continue to
report CQM results as calculated by
Certified EHR Technology by attestation
for the 2012 payment year.
Comment: One commenter was
disappointed in our proposal to
continue attestation due to our inability
to receive electronically the information
necessary for CQM reporting based
solely on the use of PQRI 2009 Registry
XML Specification content exchange
standards as is required for Certified
EHR Technology. The commenter urged
us to rectify this situation.
Response: We appreciate the
commenters’ feedback. We are working
to have the capability to receive CQM
data reported electronically via Certified
EHR Techology for the 2013 payment
year. However, we note that attestation
is only one method by which EPs may
report the CQMs. In fact, EPs may
submit CQM data through participation
in the Physician Quality Reporting
System-Medicare EHR Incentive Pilot
that is described in the following
section.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing our proposal to allow
EPs to continue to report CQM results
as calculated by Certified EHR
Technology by attestation for the 2012
payment year as proposed. We are
revising 42 CFR 495.8(a)(2)(ii) as
proposed.
3. The Physician Quality Reporting
System-Medicare EHR Incentive Pilot
In addition to attestation, we
proposed (76 FR 42900) to establish a
Pilot mechanism through which EPs
participating in the Medicare EHR
Incentive Program may report CQM
information electronically using
Certified EHR Technology for the 2012
payment year.
We proposed to modify 42 CFR
495.8(a)(2) by adding a new paragraph
to allow for the reporting of CQMs for
the Medicare EHR Incentive Program via
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot. Section
1848(o)(2)(B)(ii) of the Act provides
authority for the Secretary to accept
information on CQMs electronically on
a Pilot basis. We proposed that EPs may
participate in the Pilot on a voluntary
basis, and that those EPs who choose
not to participate may instead continue
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to attest to the results of the CQMs as
calculated by Certified EHR Technology,
consistent with the CQM reporting
method for the 2011 payment year.
However, we encourage participation in
the Pilot based on our desire to
adequately pilot electronic submission
of CQMs and to move to a system of
reporting where EPs can satisfy both the
CQM reporting requirements for the
EHR Incentive Program and the
reporting requirements for the Physician
Quality Reporting System EHR-based
reporting mechanism with a single
submission to their respective EHR
systems, who will then provide
calculated results to CMS in the form
and manner specified for each
respective program. To participate in
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot, we
proposed that EPs would be required to
electronically report the CQMs using
Certified EHR Technology via one of
two options that are based on the
existing reporting platforms of the
Physician Quality Reporting System. As
described later in this section, one
option would be based on the
infrastructure used for the Physician
Quality Reporting System EHR data
submission vendor reporting
mechanism as described in section
VI.F.1.d.3.B of this final rule with
comment period. The second option
would be based on the infrastructure
used for the Physician Quality
Reporting System EHR reporting
mechanism as described in section
VI.F.1.d.3.A of this final rule with
comment period. EPs who seek to
participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot must also participate in
the Physician Quality Reporting System
itself, because the Pilot will rely on the
infrastructure used for the Physician
Quality Reporting System.
To move towards the integration of
reporting on quality measures under the
Physician Quality Reporting System
with the reporting requirements of the
Medicare EHR Incentive Program, as
required by section 1848(m)(7) of the
Act (‘‘Integration of Physician Quality
Reporting and EHR Reporting’’), we
proposed that participation in the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot would
require EPs to submit information on
the same CQMs that were adopted for
EPs for the Medicare EHR Incentive
Program and included in Tables 6 and
7 of the July 28, 2010 final rule (75 FR
44398 through 44410). We proposed
that EPs participating in this Pilot must
submit information on the three core
measures included in Table 7, up to
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three of the alternate core measures
included in Table 7 insofar as the
denominator for one or more of the core
measures is zero, and three additional
measures from the measures included in
Table 6, as is otherwise required by the
final rule to successfully demonstrate
meaningful use (75 FR 44409 through
44411). EPs who elect to participate in
this Physician Quality Reporting
System-Medicare EHR Incentive Pilot
would still be required to report
information on the CQMs as required
under the Stage 1 criteria established for
the Medicare EHR Incentive Program
regardless of which option they select as
described later in this section. As the
reporting of CQMs is only one of the 15
core meaningful use objectives for EPs
for the Medicare EHR Incentive
Program, an EP who elects to participate
in the Physician Quality Reporting
System-Medicare EHR Incentive Pilot
would still be required to meet and
attest to the remaining 14 core
objectives and required menu set
objectives using the attestation module
on the CMS Web site for the program.
Consequently, participation in this Pilot
only applies to the method of reporting
for meeting the meaningful use CQM
objective in the EHR Incentive Program
(42 CFR 495.6(d)(10)).
To participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot, we proposed EPs
would be required to electronically
report the CQMs by choosing one of the
options described later in this section.
By submitting the required information
through the Pilot, we proposed that an
EP could submit data on the same
sample of beneficiaries to his/her EHR
system to meet the core objective for
reporting CQMs for the Medicare EHR
Incentive Program for the 2012 payment
year and the requirements for
satisfactory reporting under the
Physician Quality Reporting System.
After attesting to all other meaningful
use objectives, the EP’s attestation file
would be placed in a holding status
with respect to the CQM objective only,
until the EP reports the CQMs via one
of the Physician Quality Reporting
System-Medicare EHR Incentive Pilot
options. Thus, the EP would not know
if he/she successfully met the
requirements for the Medicare EHR
Incentive Program with respect to the
CQM objective until the CQMs are
received at the end of the submission
period for measures for the Physician
Quality Reporting System (we expect
this would be 2 months after the close
of the reporting period, which is the CY
2012, and no later than February 28,
2013). As explained later in this section,
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any EP participating in this Pilot would
be required to report CQMs based on a
full calendar year, regardless of the EP’s
year of participation in the Medicare
EHR Incentive Program.
We also proposed (76 FR 42901) that
an EP who selects one of the Pilot
options and subsequently determines
that completion of the Pilot is unfeasible
may go back into the Medicare EHR
Incentive Program attestation module on
the CMS Web site and complete
attestation for the CQMs assuming it is
within the reporting timeframes
established under the EHR Incentive
Program. Although it is possible that an
EP may find completion of the Pilot
unfeasible, we note that participating in
the Pilot provides the following
advantage to EPs: participation in this
Physician Quality Reporting SystemMedicare EHR Incentive Pilot would
allow for the receipt of EHR Incentive
Program and Physician Quality
Reporting System incentives, provided
an EP meets the provisions described
later in this section. We noted that
although the EHR Incentive Program
requires EPs to use Certified EHR
Technology, for purposes of
participating in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot, an EP’s Certified EHR
Technology must also conform to the
qualifications for an EHR under the
Physician Quality Reporting System.
Comment: Several commenters
supported our proposal to establish the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot. These
commenters lauded our efforts to align
the Physician Quality Reporting System
and EHR Incentive Program.
Response: We appreciate the
commenters’ feedback and are finalizing
our proposal to allow EPs to report
CQMs for the EHR Incentive Program
through the Physician Quality Reporting
System-Medicare EHR Incentive Pilot
for the 2012 payment year.
Comment: Although one commenter
supported our proposal to establish the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot, the
commenter urged that we defer
implementation of the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot for an additional
year.
Response: We appreciate the
commenters’ feedback. However, we
note that participation in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot is voluntary. An EP
may continue to use attestation as a
method of reporting CQMs for the 2012
payment year to satisfy this meaningful
use objective under the EHR Incentive
Program. In fact, an EP may report the
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73423
CQMs by attestation even if the EP also
chooses to participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot.
Comment: Some commenters opposed
our proposal to require a CQM reporting
period of 1 calendar year regardless of
the EP’s year of participation in the
Medicare EHR Incentive Program.
Response: We appreciate the
commenters’ feedback. While the EHR
Incentive Program only requires a 90day EHR reporting period for EPs for
their first payment year, EPs
participating in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot must report clinical
quality measures based on a full
calendar year of data for two main
reasons. First, as described in section
VI.F.1, the Physician Quality Reporting
System has established a 12-month
reporting period with respect to the EHR
reporting mechanism. Since the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot is
intended to allow reporting under both
the Physician Quality Reporting System
and the EHR Incentive Program, it is
essential that, for purposes of
participating in this Pilot, the reporting
periods be identical. Second, unlike
Certified EHR Technology that submits
data submitted by EPs at any point
throughout the year, qualified direct
EHRs and EHR data submission vendors
are only required to submit data to CMS
once, following the end of the 12-month
calendar year reporting period.
Comment: Some commenters opposed
our proposal that the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot would only collect data
about Medicare patients.
Response: We appreciate the
commenters’ feedback. However, as
described in section VI.F.1, the
Physician Quality Reporting System
only collects data related to Medicare
patients. Since the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot is intended to allow
reporting under both the Physician
Quality Reporting System and EHR
Incentive Program, the type of data
collected must only be from Medicare
patients.
Comment: One commenter stated that
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot is
unlikely to attract volunteers, unless
EHR vendors encourage participation in
this Pilot.
Response: We appreciate the
commenter’s feedback. We encourage
EPs to participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot. We believe that the
Physician Quality Reporting System-
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Medicare EHR Incentive Pilot provides
a way for EPs to submit data on a single
sample set of beneficiaries to satisfy the
requirements for two programs: the
Physician Quality Reporting System and
the EHR Incentive Program.
Comment: Several commenters did
not believe that EPs would be willing to
have their EHR Incentive Program
incentive payments delayed in order to
participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot. These commenters
urged us to find a solution to provide
timely payments.
Response: We appreciate the
commenters’ feedback. Once the data
from an EP participating in the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot is
received and CMS determines that the
EP has successfully reported the CQMs
under the Pilot, the EP would receive
his/her incentive payment under the
EHR Incentive Program if the EP has
successfully demonstrated meaningful
use. We also note that if, for some
reason, an EP finds that he or she cannot
successfully participate in the Pilot, the
EP may also report on CQMs through
attestation within the established
timeframes of the EHR Incentive
Program.
Please note that if an EP chooses to
report CQMs through attestation and
also participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot, for purposes of receiving
an EHR Incentive Program incentive, an
EP’s attestation file would not need to
be placed in a holding status for the
CQM objective. However, as stated
previously, the analysis of data for
purposes of the Physician Quality
Reporting System incentive will not be
made until after the submission period
for measures for the Physician Quality
Reporting System.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing our proposal to allow
EPs to report CQMs for the EHR
Incentive Program through the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot for the
2012 payment year as proposed.
a. EHR Data Submission Vendor-Based
Reporting Option
As discussed further in the Physician
Quality Reporting System section
VI.F.1(d).(3).(b). of this final rule with
comment period, we proposed (76 FR
42901) that EPs participating in the
Physician Quality Reporting System
may choose to report the Physician
Quality Reporting System measures to
CMS via a Physician Quality Reporting
System qualified EHR data submission
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vendor. For purposes of the Physician
Quality Reporting System, a Physician
Quality Reporting System qualified EHR
data submission vendor will receive
data from an EP’s EHR and subsequently
reformat and transmit the data in
aggregate form on behalf of the EP to
CMS. We noted that we expect to post
a list of the 2012 Physician Quality
Reporting System EHR data submission
vendors that are qualified to submit data
from an EP’s Certified EHR Technology
to CMS on the EP’s behalf on the
Physician Quality Reporting System
section of the CMS Web site (https://
www.cms.gov/pqrs) by summer 2012.
Under this option, the Physician
Quality Reporting System qualified EHR
data submission vendor would calculate
the CQMs from the EP’s Certified EHR
Technology and then submit the
calculated results to CMS on the EP’s
behalf via a secure portal for purposes
of this Pilot. We explained that under
this option, the calculated results would
be different from what is required by the
July 28, 2010 final rule in that the data
would be: (1) Limited to Medicare
patients rather than all patients; and (2)
based on a CQM reporting period of 1
calendar year regardless of the EP’s year
of participation in the Medicare EHR
Incentive Program.
The following is a summary of the
comments we received on the proposed
EHR data submission vendor-based
reporting option under the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot.
Comment: Some commenters
supported the proposed EHR data
submission vendor-based reporting
option of the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot.
Response: We appreciate the
commenters’ feedback and are finalizing
the EHR data submission vendor-based
reporting option under the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot as proposed.
Comment: Some commenters believed
that, in order to earn a Physician
Quality Reporting System incentive
through participation in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot, an EP’s data
submission vendor was required to
submit patient-level data from which we
would calculate CQM results using a
uniform calculation process. One
commenter asked why providing
aggregate-level data would not suffice
for meeting the CQM reporting objective
through participation in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot.
Response: We appreciate the
commenters’ feedback. We note that
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incentives for either the Physician
Quality Reporting System or the
Medicare EHR Incentive Program, are
earned under each respective program.
For purposes of the Pilot, a qualified
EHR data submission vendor would
submit individual-level data as well as
the calculated results of the CQMs to us.
While the submission of calculated
results is required for an eligible
professional using this EHR data
submission vendorbased reporting
option to qualify for an incentive under
the EHR Incentive Program, the
Physician Quality Reporting System, as
described previously in section VI.F.1 of
this final rule, receives individual-level
data from claims and EHR-based
reporting to analyze whether an eligible
professional has met the requirements
for satisfactory reporting under the
Physician Quality Reporting System.
Therefore, in order for us to be able to
calculate measure data for purposes of
earning a Physician Quality Reporting
System incentive, we are requiring CQM
data elements to be submitted by an
EP’s qualified EHR data submission
vendor at an individual level. Further,
the Physician Quality Reporting System
requires this individual-level data to be
submitted in the QRDA format. We
believe it is useful to utilize a standard
(such as CDA of which QRDA is a
subset) where one exists in our quality
reporting initiatives.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing the EHR data
submission vendor-based reporting
option for the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot as proposed.
b. Direct EHR-Based Reporting Option
As discussed further in the Physician
Quality Reporting System section
VI.F.1.(d).(3).(a). of this final rule with
comment period, we proposed (76 FR
42901) that EPs participating in the
Physician Quality Reporting System via
the direct EHR-based reporting
mechanism can choose to report the
Physician Quality Reporting System
measures to CMS directly from the EP’s
EHR. Therefore, under this direct EHRbased reporting option, we proposed (76
FR 42901) that an EP participating in
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot would
submit CQM data directly from his or
her Certified EHR Technology to CMS
via a secure portal using the
infrastructure of the Physician Quality
Reporting System EHR reporting
mechanism. We proposed that in order
to participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot under this option, the
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EP’s Certified EHR Technology must
also be a 2012 Physician Quality
Reporting System qualified EHR. We
expect to post a list of the 2012
Physician Quality Reporting System
qualified EHRs on the Physician Quality
Reporting System section of the CMS
Web site prior to January 1, 2012. Due
to this Physician Quality Reporting
System-Medicare EHR Incentive Pilot,
we proposed to have an additional
vetting process for EHR vendors wishing
to participate in the Pilot. We expect to
post a list of these additional 2012
qualified EHR vendors, if applicable,
and their products in the summer of
2012.
Under this direct EHR-based reporting
option, the data would be different from
what is required by the July 28, 2010
final rule in that it would be: (1) limited
to Medicare patients rather than all
patients; (2) patient-level data from
which we may calculate CQM results
using a uniform calculation process,
rather than aggregate results calculated
by the EP’s Certified EHR Technology;
and (3) based on a CQM reporting
period of 1 calendar year regardless of
the EP’s year of participation in the
Medicare EHR Incentive Program.
In addition, we proposed (76 FR
42901) that if an EP successfully
submits all required CQM data from
Certified EHR Technology, which also
must be a Physician Quality Reporting
System qualified EHR product, directly
to CMS, then the EP would also meet
the criteria for satisfactory reporting
under the 2012 Physician Quality
Reporting System, which would also
qualify the EP for an incentive under the
2012 Physician Quality Reporting
System.
The following is a summary of the
comments we received related to the
direct EHR-based reporting option
under the Physician Quality Reporting
System-Medicare EHR Incentive Pilot.
Comment: Several commenters
supported the proposed direct EHRbased reporting option of the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot.
Response: We appreciate the
commenters’ feedback and are finalizing
the direct EHR-based reporting option
under the Physician Quality Reporting
System-Medicare EHR Incentive Pilot.
Comment: Several commenters urged
CMS to align the Physician Quality
Reporting System qualification
requirements for EHRs with the
certification requirements for Certified
EHR Technology so that a single EHR
system could serve reporting
requirements for both programs.
Response: We appreciate the
comementers’ feedback. We are working
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to align the EHR system requirements
for the Physician Quality Reporting
System and the EHR Incentive Program.
However, for purposes of participating
in the Physician Quality Reporting
System-Medicare EHR Incentive Pilot
under the direct EHR-based reporting
option, Certified EHR Technology must
also meet the qualification requirements
stated under section VI.F.1.d.3 of this
final rule with comment period. There
are currently distinct differences
between Certified EHR Technology and
EHR systems that are qualified under
the Physician Quality Reporting System.
For example, as required by ONC’s
regulations (see 45 CFR part 170),
Certified EHR Technology must include
certain functionalities, such as the
ability to create a summary of care
record for transitions of care, the ability
to calculate and submit clinical quality
measures specified for the EHR
Incentive Program, and must also have
certain structured data elements that use
specific language (for example,
SNOMED, LOINC). On the other hand,
an EHR that is ‘‘qualified’’ under the
Physician Quality Reporting System is
one that can capture all Physician
Quality Reporting System measures,
extract the data elements needed to
calculate the measures, place the data
elements in a QRDA format, and
successfully transmit that data into the
CMS portal. Therefore, it is necessary
that an EHR system be qualified so as to
ensure the system has the capability to
report on Physician Quality Reporting
System measures.
We note that there are EHR systems
that are both ‘‘qualified’’ to report
Physician Quality Reporting System
quality measures and classified as
Certified EHR Technology for purposes
of reporting under the EHR Incentive
Program. A list of EHR products that are
both ‘‘qualified’’ and Certified EHR
Technology will be made available on
the Physician Quality Reporting System
Web site, available at https://
www.cms.gov/PQRS/.
Based on the comments received and
for the reasons stated in our responses,
we are finalizing the EHR-based
reporting option under the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot as proposed.
The Medicare EHR Incentive Program
clinical quality measures, including the
core and alternate core measures, and
the 38 additional measures, are found in
the Physician Quality Reporting
System’s Table 48 of this final rule with
comment period.
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73425
4. Method for EPs to Indicate Election
To Participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot for Payment Year 2012
We proposed (76 FR 42902) that EPs
who wish to participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot would be able to
indicate within the EHR Incentive
Program attestation module their intent
to fulfill the meaningful use objective of
reporting CQMs by participating in the
Physician Quality Reporting SystemMedicare EHR Incentive Pilot. The EHR
Incentive Program attestation module is
available on the CMS Web site at
https://www.cms.gov/
EHRIncentivePrograms/
32_Attestation.asp#TopOfPage. The
following is a summary of the comments
we received that were related to this
proposal.
Comment: Several commenters sought
further clarification on how EPs may
participate in the Physician Quality
Reporting System-Medicare EHR
Incentive Pilot.
Response: We appreciate the
commenters’ feedback. We will provide
additional guidance on the process for
participating in the Pilot, which will be
available on the EHR Incentive Program
Web site, available at https://
www.cms.gov/ehrincentiveprograms/, as
well as the Physician Quality Reporting
System Web site, available at https://
www.cms.gov/PQRS/.
Based on the comments received and
for the reasons stated previously, we are
finalizing our method to indicate
election to participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot as proposed.
I. Establishment of the Value-Based
Payment Modifier and Improvements to
the Physician Feedback Program
1. Overview
In the proposed rule, we described the
statutory requirements governing the
Physician Feedback Program and the
Physician Value-Based Payment
Modifier (‘‘value modifier’’), which will
be applied to the Physician Fee
Schedule starting in 2015 for certain
physicians and groups of physicians
and, starting in 2017 for all physicians
and other eligible professionals as the
Secretary determines appropriate (76 FR
42908). In particular, we proposed that
certain of the quality of care measures
in the Physician Quality Reporting
System and the Electronic Health
Records (EHR) Incentive Program be
used to evaluate the quality of care in
the value modifier (76 FR 42909 through
42912). In addition, we described how
the quality of care measures that
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physicians report in the Physician
Quality Reporting System will be used
in the confidential feedback reports we
provide to physicians under the
Physician Feedback Program (76 FR
42903 through 42907). We explained
that we are using the Physician
Feedback Program reports to help
develop and test different
methodologies that we could use to
calculate the value modifier.
In this final rule with comment
period, we emphasize the connection
between our physician quality
programs—the Physician Quality
Reporting System, the EHR Incentive
Program, the value modifier, and the
Physician Feedback Program. Our
primary interests in aligning these
programs are to increase the quality of
care for Medicare beneficiaries, to
provide a common basis to do so that
does not increase physician reporting
burden, and to provide fair and
meaningful information to physicians
on ways to improve the quality of care
they furnish.
We also emphasized in the proposed
rule that given the complexity of
measuring physician performance and
calculating the value modifier, we are
proceeding cautiously with
transparency and outreach in a variety
of ways to obtain stakeholder input. We
discuss in this final rule with comment
period several ways we plan to engage
stakeholders to obtain input as we move
forward to implement the value
modifier over the coming years.
2. The Value-Based Payment Modifier
Section 1848(p) of the Act requires
the Secretary to ‘‘establish a payment
modifier that provides for differential
payment to a physician or a group of
physicians’’ under the physician fee
schedule ‘‘based upon the quality of
care furnished compared to cost * * *
during a performance period.’’ The
provision requires that ‘‘such payment
modifier be separate from the
geographic adjustment factors’’
established for the physician fee
schedule. In addition, section
1848(p)(4)(C) of the Act requires that the
value modifier be implemented in a
budget-neutral manner. Budget
neutrality means that payments will
increase for some physicians but
decrease for others, but the aggregate
amount of Medicare spending in any
given year for physicians’ services will
not change as a result of application of
the value modifier.
Section 1848(p)(4)(B)(iii) of the Act
requires the Secretary to apply the value
modifier beginning January 1, 2015 to
specific physicians and groups of
physicians the Secretary determines
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appropriate. This section also requires
the Secretary to apply the value
modifier with respect to all physicians
and groups of physicians (and may
apply to eligible professionals as
defined in subsection (k)(3)(B) of the
Act as the Secretary determines
appropriate) beginning not later than
January 1, 2017.
We view the value modifier as an
important component in revamping how
care and services are paid for under the
physician fee schedule. Currently,
payments under the physician fee
schedule are generally based on the
relative resources involved with
furnishing each service, and are
adjusted for differences in resource
inputs among geographic areas. Thus,
all physicians in a geographic area are
paid the same amount for individual
services regardless of the quality of care
or outcomes of services they furnish.
Although the fee schedule payments
will soon be adjusted depending upon
whether eligible professionals are
satisfactory reporters of Physician
Quality Reporting System quality
measures, successful electronic
prescribers and meaningful users of
electronic health records (EHRs), these
adjustments do not currently take into
account performance on the quality
measures collected under these
programs. In addition, the fee schedule
does not take into account the overall
costs of services furnished or ordered by
physicians for individual Medicare
beneficiaries. These limitations mean
that the physician fee schedule does not
contain incentives for physicians to
focus on: (1) The quality and outcomes
of all the care furnished to beneficiaries;
(2) the relative value of each service
they furnish or order; or (3) the
cumulative costs of their own services
and the services that their beneficiaries
receive from other providers.
We noted in the proposed rule that
Medicare is beginning to implement
value-based payment adjustments for
other types of services, including
hospital services, skilled nursing
facilities, home health agencies, and
ambulatory surgical centers (76 FR
42908). In implementing value-based
purchasing initiatives generally, we seek
to meet the following goals:
• Improving quality.
++ Value-based payment systems and
public reporting should rely on a mix of
standards, processes, outcomes, and
patient experience measures, including
measures of care transitions and
changes in patient functional status.
Across all programs, we seek to move as
quickly as possible to the use of
outcome and patient experience
measures. To the extent practicable and
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appropriate, we believe these outcome
and patient experience measures should
be adjusted for risk or other appropriate
patient population or provider
characteristics.
++ To the extent possible, and
recognizing differences in payment
system readiness and statutory
requirements and authorities, measures
should be aligned across Medicare and
Medicaid’s public reporting and
payment systems. We seek to evolve a
focused core set of measures appropriate
to each specific provider category that
reflects the level of care and the most
important areas of service and measures
for a particular provider.
++ The collection of information
should minimize the burden on
providers to the extent possible. As part
of that effort, we will continuously seek
to align our measures with the adoption
of meaningful use standards for health
information technology (HIT), so the
collection of performance information is
part of care delivery.
++ To the extent practicable,
measures used by us should be
nationally endorsed by a multistakeholder organization. Measures
should be aligned with best practices
among other payers and the needs of the
end users of the measures.
• Lowering per-capita growth in
expenditures.
++ Providers should be accountable
for the costs of care, and be rewarded for
reducing unnecessary expenditures and
be responsible for excess expenditures.
++ In reducing excess expenditures,
reductions should not compromise
patient care and providers should
continually improve the quality of care
they deliver.
++ To the extent possible, and
recognizing differences in payers’ value
based purchasing initiatives, providers
should apply -quality-improving and
cost-reducing redesigned care processes
to their entire patient population.
Section 1848(p)(4)(A) of the Act
requires us to publish, not later than
January 1, 2012, three items related to
the establishment of the value modifier:
(a) the quality of care and cost measures
established by the Secretary for
purposes of the modifier; (b) the dates
for implementation of the value
modifier; and (c) the initial performance
period for application of the value
modifier in 2015. In the proposed rule
we made proposals for each of these
requirements and we discuss each
below.
a. Measures of Quality of Care and Costs
(1). Quality of Care Measures
Section 1848(p)(2) of the Act requires
that physician quality of care be
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evaluated, to the extent practicable,
based on a composite of measures of the
quality of care furnished. Section
1848(p)(2)(B) of the Act requires that the
Secretary establish appropriate
measures of the quality of care
furnished by a physician or a group of
physicians to Medicare beneficiaries
such as measures that reflect health
outcomes. The statute requires the
measures to be risk adjusted as
determined appropriate by the
Secretary. Section 1848(p)(2)(B)(ii) of
the Act requires the Secretary to seek
endorsement of the quality of care
measures by the entity with a contract
under section 1890(a) of the Act, which
is the National Quality Forum.
(A) Quality of Care Measures for the
Value-Modifier
For purposes of section
1848(p)(4)(A)(i) of the Act, we proposed
to use performance on: (1) The measures
in the core set of the Physician Quality
Reporting System for 2012; (2) all
measures in the Group Practice
Reporting Option of the Physician
Quality Reporting System for 2012; and
(3) the core measures, alternate core,
and 38 additional measures in the EHR
Incentive Program measures for 2012
(76 FR 42909). We requested comment
on the proposed measures, on our
interest to establish a core measure set
for the value modifier, and whether to
include additional (or exclude)
measures from the Physician Quality
Reporting System in the quality of care
measures for the value modifier.
We also proposed that, to the extent
that the 2013 measures adopted for the
Physician Quality Reporting System and
EHR Incentive Program are different
than those used in 2012, we would
consider, through rulemaking next year,
revising the value modifier quality
measures applicable to 2013 to be
consistent with the revisions made to
the measures for those programs.
Comment: Most commenters
appreciated CMS’ proposal to use a
consistent set of quality of care
measures across various quality
programs. Despite this support, some
commenters recommended using either
one core set of measures or multiple sets
of core measures for different types of
physicians or conditions. For example,
one commenter recommended requiring
physicians to report on only a ‘‘small set
of core measures that would be
applicable to all physicians plus some
limited number of applicable measures
chosen by the physician or group
practice.’’ Other commenters suggested
that we start with a small core set of
measures initially and then transition to
a larger set over time. By contrast, many
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commenters urged CMS to use a
different core set of measures for
different physician specialties (rather
than the same measures for all
physicians) in the value modifier.
MedPAC suggested that ‘‘the use of a
large number of [quality] measures in
the value modifier could increase the
year-to-year statistical variability, and
therefore uncertainty, into the annual
calculation of each physician’s or
physician group’s value modifier.’’
MedPAC recommended that we
concentrate on a few key populationbased outcomes, patient experience, and
clinical process measures. A few
commenters supported including
outcome measures that assess the rate of
potentially preventable hospital
admissions for six ambulatory care
sensitive conditions at the group
practice level: diabetes, bacterial
pneumonia, dehydration, COPD, urinary
tract infection, and heart failure.
Many physician specialty societies
indicated that the proposed quality
measures did not have measures
relevant to the practice of their
physicians or to the conditions they
treat and, therefore, it would not be
possible to calculate a quality composite
for them. Most prominently in this
category were surgeons and surgical
specialties, hospital-based physicians,
and medical subspecialists. Some
medical specialists, for example
cardiologists and endocrinologists,
commented that proposed measures
which seemed applicable to them did
not measure the quality of care provided
by subspecialists. These commenters
stated that they would work with us to
develop relevant clinical measures and
to assist in obtaining National Quality
Forum endorsement of new measures.
Of the proposed measures in the EHR
Incentive program set for 2012, several
commenters opposed including PQRS
measure #200 (Heart Failure: Warfarin
Therapy for Patients with Atrial
Fibrillation) because clinical guidelines
have been updated and those changes
are not currently reflected in the PQRS
measure.
A number of commenters suggested
that the value modifier’s quality of care
measures should directly correspond to
the proposed condition-specific cost
measures. One commenter suggested
that for hospital-based physicians, CMS
align the quality measures in the
hospital value-based purchasing
program with the physician value
modifier.
Response: We appreciate commenters’
support for our proposals to use a
consistent set of measures across quality
improvement programs and to use of a
core set of measures for the value
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73427
modifier. We recognize that the
proposed core sets of quality measures
for individual physicians—the
Physician Quality Reporting System
core set (which focuses on
cardiovascular conditions) and the core,
alternative core, and additional EHR
Incentive Program measures (which
focus on several chronic conditions and
preventive measures)—and the core set
for physicians in groups—the Group
Practice Reporting Option measures
(which also focus on chronic conditions
and preventive measures)—do not cover
the full range of conditions prevalent in
the Medicare population or varied
physician specialties. We have focused
on these quality of care measures for the
value modifier because they assess
highly prevalent and high-cost
conditions in the Medicare population
and we encourage physicians to take
these conditions into account when
treating their patients. We further
believe that the proposed measures are
an appropriate starting point for the
value modifier because they also
include preventive services and thus,
are important measures of the quality of
care that these beneficiaries receive.
We agree with commenters’ concerns
about PQRS measure #200 and we will
not include it in the value modifier for
the initial performance period because
its specifications have not been
updated.
We anticipate assessing physician
performance for more conditions and/or
by specialty in subsequent years after
the methodological issues surrounding
the value modifier are finalized. We
believe that we will ultimately need to
include quality of care measures
applicable to most physicians and
highly prevalent conditions, as well as
measures for specific types of
physicians, in order to calculate a value
modifier for every physician by 2017.
We agree with commenters that we
should concentrate on outcome, patient
experience, and clinical process
measures in the value modifier. As a
first step in that direction, we will
include outcome measures that assess
the rate of potentially preventable
hospital admissions for two of the six
ambulatory care sensitive conditions at
the group practice level that we have
used in the Physician Feedback Program
reports: heart failure and chronic
obstructive pulmonary disease. We have
chosen these two measures because they
are important conditions among
Medicare FFS beneficiaries and, based
on our 2010 Physician Feedback
Program group reports, contain sample
sizes sufficient for reliable
measurement.
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In addition, we also clarify that we do
not seek to evaluate individual
physicians on each measure we
proposed or include in a future set of
measures, but rather to assess physician
performance using quality of care
measures for the types of care they
provide and the measures they report.
Nonetheless, we agree with
commenters that we should match our
quality of care measures with the cost
measures that we have proposed for
specific conditions. In the discussion
below, we proposed per capita cost
measures for beneficiaries with four
chronic conditions (chronic obstructive
pulmonary disease; heart failure;
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coronary artery disease; and diabetes) in
the value modifier. To match these cost
measures with the quality of care
measures, we anticipate that we will
propose in next year’s rulemaking to
include the additional measures for
each of these conditions from the
Physician Quality Reporting System
measure groups that are not already
included in the measure set we are
finalizing in this final rule with
comment period.
We agree that we should use NQFendorsed measures of quality where
appropriate. In addition, we will reach
out to physician specialty organizations
for conditions where we lack measures
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or for conditions where we have cost
measures but insufficient quality
measures in order to develop a robust
value modifier.
We are finalizing our proposal, for
individual physicians to whom the
value modifier will apply, to include the
core set of the Physician Quality
Reporting System for 2012 and the core
measures, alternate core, and additional
measures in the EHR incentive program
for 2012 (except for PQRS measure #200
as discussed previously). These
measures are listed in Table 80.
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For physicians practicing in groups,
the measures we are finalizing for the
value modifier include all measures in
the Group Practice Reporting Option of
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the Physician Quality Reporting System
for 2012 and the rates of potentially
preventable hospital admissions for two
ambulatory care sensitive conditions at
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the group practice level: heart failure
and chronic obstructive pulmonary
disease. These measures are listed in
Table 81.
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We expect to update these quality of
care measures based on the measures
finalized in subsequent rulemaking
under the Physician Quality Reporting
System and the EHR Incentive Program
for the initial performance year. By
doing so, we anticipate the value
modifier would use the same quality of
care measures that are included in the
Physician Quality Reporting System
and/or the EHR Incentive Program for
the initial performance year. To the
extent physicians are already reporting
the quality of care measures under the
Physician Quality Reporting System
and/or the EHR Incentive Program, this
step would reduce program
inconsistencies and reduce the reporting
burden on physicians.
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(B) Potential Quality of Care Measures
for Additional Dimensions of Care in
the Value Modifier
We explained in the proposed rule
that one of the goals of this notice and
comment rulemaking is to identify
potential measures that could provide a
richer picture of the quality of care
furnished by a physician (76 FR 42911).
For example, we indicated that we are
interested in quality measures that
assess the care provided by specialists.
We specifically requested comment
from specialists about measures that
were not included in the list of
proposed measures. In addition, we also
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requested comment on outcome, care
coordination/transition, patient safety,
patient experience, and functional
status measures (which are discussed
below) as well as the 28 administrative
claims measures (described below with
respect to the 2010 Physician Feedback
reports disseminated in 2011) and
whether we should include them in the
value modifier. We especially urged the
physician community and private
payers that have been engaged in payfor-performance programs to identify
other quality measures that they have
used and to describe their experience
with these measures. We requested
comment on how these measures align
with current private sector quality
measurement initiatives.
Comment: As previously noted
commenters supported CMS’ efforts to
develop quality measures applicable to
specialists. The commenters urged CMS
to add measures that provide an
accurate and comprehensive view of
how physicians perform in practice.
Commenters, including the surgical
community, suggested measures related
to vascular surgery lower extremity
bypass, surgical site infection, urinary
tract infection, colon surgery, and
surgery in the elderly. The
anesthesiology community suggested
perioperative and pain management
measures. Pathologists suggested very
specific measures related to Barrett’s
esophagus and radical prostatectomy
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reporting as well as
immunohistochemical evaluation for
breast cancer. Other commenters
suggested adding measures for adult
immunization (including Hepatitis A
and B), stroke, rheumatoid arthritis,
pelvic prolapse, infection prevention as
well as measures to prevent unnecessary
emergency room visits and decrease
hospital readmissions. The commenters
recommended CMS develop a process to
address outdated elements among
proposed measures. Several commenters
opposed use of administrative claimsbased measures because of their
inability to capture information that
may influence a physician’s care.
Several commenters questioned the use
of the proposed cardiac and diabetes
measures, because they believed these
measures do not reflect the specialized
care given. Additionally, commenters
opposed the claims-based measure ‘‘Use
of high risk medication in the Elderly’’
because the list of medications has not
been updated regularly.
Response: We thank commenters for
sharing their views. We will be working
internally and reaching out to
stakeholders to consider these
comments and to make proposals in
future rulemakings to refine the quality
measures included in the value
modifier. We do not plan at this time to
include the 28 administrative claimsbased measures we used in the
individual 2010 Physician Feedback
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Program reports in the value modifier:
thus the ‘‘Use of High Risk medications
in the Elderly’’ measure will not be
included in the value modifier. A
substantial number of these 28
administrative claims-based measures
rely on drug-related data that we cannot
obtain for all Medicare beneficiaries
because not all Medicare beneficiaries
are enrolled in a Medicare Part D plan.
In addition, some of the administrative
claims-based measures overlap with the
Physician Quality Reporting System
measures we are adopting for the value
modifier, and thus are duplicative.
(i) Outcome Measures
As discussed previously, we sought
comment on the use of measures in the
future that assess the rate of potentially
preventable hospital admissions for six
ambulatory care-sensitive conditions at
the practice group level: diabetes,
bacterial pneumonia, dehydration,
chronic obstructive pulmonary disease
(COPD), urinary tract infection, and
heart failure (76 FR 42912). We also
sought comment on an all-cause
hospital readmission measure.
We also sought suggestions on other
outcome measures that would be
appropriate measures of the quality of
care furnished for purposes of the value
modifier, such as measures that examine
emergency room use for ambulatory care
sensitive conditions. We indicated we
were interested in outcome measures
that can be calculated from existing
Medicare claims data and do not require
additional reporting by physicians. In
addition, we stated we were particularly
interested in comments on potential
measures of complications that would
be appropriate to include in the value
modifier (76 FR 42912).
Comment: The majority of
commenters supported CMS’ interest in
moving to a system that focuses on
outcome measures. They strongly
emphasized such measures should be
indicative of physician performance and
control. Many commenters suggested
that all outcome measures must be riskadjusted appropriately to account for
the complexity and severity of the
patient’s condition(s). Commenters
urged us to ensure that the risk
adjustment methodology would be
sufficient such that physicians are not
discouraged from caring for the highly
complex patients. The commenters
noted that physicians should not be
held accountable for patient factors
outside of their control that may
influence outcomes such as patient
adherence or other patient attributes
(such as education, literacy,
socioeconomic status). Two commenters
expressed concern with an all-cause
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hospital readmission measure that had
not yet been developed and which
would assess physicians on an event
over which physicians do not have
complete control.
Response: We thank commenters for
their support for outcome measures. We
agree with commenters that we should
move toward including in the value
modifier quality of care measures that
assess patient outcomes. As discussed
previously, as a first step in that
direction we are finalizing outcome
measures that assess the rate of
potentially preventable hospital
admission at the group practice level for
heart failure and chronic obstructive
pulmonary disease. We anticipate
proposing in next year’s rulemaking to
include outcome measures that assess
the rate of potentially preventable
hospital admissions for other
ambulatory care sensitive conditions at
the group practice level. As we move
forward, we will take concerns about
risk adjustment of these measures into
consideration as we incorporate them
into the value modifier.
(ii) Care Coordination/Transition
Measures
We also noted in the proposed rule
that care transitions such as transition of
a beneficiary from an inpatient setting to
the community or to a post-acute setting
are important aspects of quality of care
furnished (76 FR 42912). We requested
input about these and other potential
aspects of care coordination/transitions
for which measures could be developed
and/or used for purposes of the value
modifier.
Comment: Many commenters
generally supported the use of care
coordination and transition measures
but cited the need for a robust riskadjustment methodology with these
measures. Conversely, several
commenters opposed the use of care
coordination/transition measures, citing
that use of these measures ‘‘requires a
level of coordination which may only be
found in highly integrated care systems
such as an accountable care
organization (ACO) or comprehensive
medical homes.’’ Indeed, many
commenters recommended that we
focus on integrated groups and systems
of care where care coordination was
implemented and could be measured.
The commenters also voiced concern
over creating care coordination
measures when providers are not
presently reimbursed for this type of
care. Many commenters, especially
hospital-based providers, also pointed
out that data was often simply not
available to them or did not exist (that
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73433
is, the patient had no primary care
physician with whom to communicate).
Response: We thank the commenters
for their suggestions. As we noted in the
proposed rule, to the extent that we
develop care coordination/transition
measures, we will propose them in
future rulemaking for inclusion in the
value modifier. We continue to believe
that care coordination/transitions are
important aspects of quality of care
furnished and we will be working with
stakeholders to develop appropriate
measures.
(iii) Patient Safety, Patient Experience,
and Functional Status
We explained in the proposed rule
that measures of patient safety, patient
experience, and functional status were
important dimensions of care for the
value modifier (76 FR 42912). We
sought comment about potential patient
safety measures that could be developed
and/or used for purposes of the value
modifier. To the extent commenters
were aware of potential measures of
patient safety, patient experience, or
functional status that we could use, we
welcomed such suggestions.
Comment: Many commenters favored
the inclusion of patient safety,
experience of care, and functional status
measures in the value modifier and
offered general suggestions for inclusion
of such measures. Many commenters
supported patient experience measures
for general and specialty physicians and
there were also recommendations for
the use of standard assessment tools and
patient experience tools which could be
used.
Response: We thank commenters for
their suggestions and agree that this is
an important area for development of
measures and the infrastructure to
support them. We will consider them in
the future as we focus on additional
areas where physician value can be
improved.
(2) Cost Measures
Section 1848(p)(3) of the Act requires
that cost measures used in the value
modifier be evaluated, to the extent
practicable, based on a composite of
appropriate measures of costs
established by the Secretary. This
composite would eliminate the effect of
geographic adjustments in payment
rates and account for risk factors and
other factors so that physicians and
groups of physicians would be
compared on an equal basis. In other
words, comparisons of the quality of
care furnished compared to cost would
be on an ‘‘apples-to-apples’’ basis so
that physicians in high cost areas would
not be penalized unfairly and
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physicians in low-cost areas would not
be rewarded unjustly.
(A) Cost Measures for the Value
Modifier
We proposed to use total per capita
cost measures and per capita cost
measures for beneficiaries with four
chronic conditions (COPD; heart failure;
coronary artery disease; and diabetes) in
the value modifier (76 FR 42913). Our
2010 Physician Feedback Program
reports use a total per capita cost
measure and per capita cost measures
for the overall costs for beneficiaries
with these four chronic conditions.
These per capita cost measures are
adjusted for geographic differences and
they are risk adjusted to ensure
geographic and clinical comparability,
as required by section 1848(p)(3) of the
Act.
We explained that these cost
measures would be compared to the
quality of care furnished for use in
determining the value modifier.
Comment: Most commenters agreed
with our proposal to use in the initial
years of the value modifier both total
per capita cost measures and per capita
cost measures for COPD; heart failure;
coronary artery disease; and diabetes.
Commenters urged CMS to clarify
which beneficiaries will be included for
assessing costs in each of these four
chronic conditions. Many commenters
suggested CMS move quickly to the use
of episode-based cost measures.
Commenters also requested that CMS
move forward with the episode grouper
in a transparent fashion and suggested
that CMS have public sessions through
an appropriate venue to apprise the
public of our progress.
Several commenters questioned CMS’
methodology to eliminate geographic
differences in Medicare’s payment and,
in particular, how the Geographic Price
Cost Indices (GPCIs) would be handled.
In addition, commenters stated that the
risk adjustment methodology we
currently use for the cost measures in
the Physician Feedback Program was
not sufficiently robust to adequately
account for the differences among
patient populations especially those that
cared for high acuity populations. Many
commenters said that until a risk
adjustment methodology could
adequately adjust for patient factors
outside of the physician’s control like
severity of disease or patient adherence,
it would not be possible to calculate a
meaningful composite of cost for the
value modifier. Many commenters
expressed the desire for increased
communication and transparency about
the methodology for the composites that
will comprise the value modifier.
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Response: We believe that total per
capita cost measures are useful overall
measures of the volume of healthcare
services furnished to beneficiaries. In
addition, the total per capita costs for
patients with diabetes, coronary artery
disease, COPD, and heart failure can
provide information on the volume of
care provided to these patients. We also
agree that episode-specific costs of care
are valuable measures and we intend to
evaluate how to include them in the
value modifier in future years, as further
discussed below.
We believe that the current risk
adjustment methodology, the hierarchal
condition categories model (HCC),
reasonably predicts high- and low-cost
beneficiaries.1 In addition, the model’s
explanatory power has increased over
recent years and it is recalibrated
regularly for more recent diagnoses and
expenditure data. We are unaware of
generally used risk adjustment models
that can adjust broadly for patient
factors cited by the commenters; nor did
commenters present evidence that the
HCC model was inadequate or
disadvantages physicians that care for
certain types of patients.
The methodology we currently use in
the Physician Feedback Program reports
to ensure we compare Medicare
payments on an ‘‘apples-to-apples’’
basis equalizes the differences in
payment rates due to geography among
the same class of providers.2 Thus, the
effects of the GPCIs are removed from
our payments. In other words, actual
Medicare payments are adjusted such
that a given service is priced at the same
level across all providers within the
same facility type or setting, regardless
of geographic area or differences in
Medicare payment rates among
facilities.
We agree with commenters that our
risk adjustment and price
standardization methodologies must be
transparent. In the next several months,
we will host public events to further
gather input on the value modifier and
explain the price standardization and
risk adjustment methodologies so that
physicians and other stakeholders have
1 RTI, ‘‘Evaluation of the CMS–HCC Risk
Adjustment Methodology,’’ (March 2011), available
at: https://www.cms.gov/
MedicareAdvtgSpecRateStats/downloads/
Evaluation_Risk_Adj_Model_2011.pdf (recent
overview of the HCC model and the development
of the methodology over the past several years).
2 For additional information about price
standardization, see ‘‘Methodology and Process
Specifications for the Physician Quality Reporting
System Group Practice Reporting Option Quality
and Resource Use Reports’’ (September 2011)
available at: https://www.cms.gov/
PhysicianFeedbackProgram/Downloads/
2010_GPRO_QRUR_Detailed_Methodology.pdf.
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a full understanding of our efforts to
ensure fair and accurate calculation of
per capita costs.
After consideration of the public
comments we received, we are
finalizing our proposal to use total per
capita cost measures and per capita cost
measures for beneficiaries with four
specific chronic conditions (chronic
obstructive pulmonary disease, heart
failure, coronary artery disease, and
diabetes) in the value modifier.
(B) Potential Cost Measures for Future
Use in the Value Modifier
Section 1848(n)(9)(A) of the Act
requires us to develop by January 1,
2012, an episode grouper that combines
separate, but clinically related items and
services into an episode of care for an
individual, as appropriate. We
explained that during 2012 we will test
and plan how to use an ‘‘episode
grouper’’ (76 FR 42913).
As a transition to implementing the
episode grouper, we explained that we
could use cost measures based on the
inpatient hospital Medicare Severity
Diagnosis Related Groups (MS–DRG)
classification system. We requested
comment on whether we should pursue
the MS–DRG approach in the near term
while we develop episode-based cost
measures for a significant number of
high-cost and high-volume conditions
in the Medicare program. In addition,
we specifically sought comment on the
resource and cost measures used in
private sector initiatives and how they
are used to profile physicians compared
to the quality of care provided.
Comment: Commenters indicated that
CMS should rapidly transition to
episode-based cost measures and also
communicate with stakeholders
frequently about the status of the
episode grouper and the methodology as
it evolves. A number of commenters did
not think that the use of an MS–DRG
approach in the short run was useful.
Response: We agree with commenters
that the use of episode-based costs can
be a valuable input into the value
modifier. Prior to incorporating episodebased costs into the value modifier, we
will hold stakeholder events to share
our progress on the episode grouper to
ensure transparency of the methodology
underlying any grouping of the costs of
various items and services.
b. Implementation of the Value Modifier
We explained in the proposed rule
that there a number of issues related to
the implementation of the value
modifier including steps for both
measurement of performance and
application of payment adjustments (76
FR 42913). Although we did not make
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proposals, we stated that our plan is to
begin implementing the value modifier
through the rulemaking process during
2013 as required by section
1848(p)(4)(B)(i) of the Act. We requested
input from stakeholders as we work on
these issues.
Comment: Many commenters doubted
whether meaningful composites of
quality and cost that capture physician
‘‘value’’ could be developed in time for
2017, if ever. Many commenters cited
the challenges of how to assign patients
to physicians and the adequacy of risk
adjustment methods to ensure that
physicians are not discouraged from
caring for patients with highly complex
conditions. Others cited the lack of
meaningful quality measures for many
types of physicians as a challenge to the
calculation of the value modifier. Many
commenters suggested that we appeal to
the Congress for a substantial delay in
the timeline for implementation of the
physician value modifier.
Response: We appreciate commenters’
concerns and recognize the challenges
before us as we move to a payment
system that begins to encourage
physicians to focus on the relative value
of each service they furnish or order, the
cumulative cost of their own services
and services that their beneficiaries
receive, and the quality and outcomes of
the care furnished to beneficiaries.
We realize that for some physicians,
the transition to a focus on value will
require a new way of thinking about the
practice of medicine. And, it is
important that value is being assessed in
a manner which acknowledges and
takes into account the diversity of
patient conditions and physician
practices. Given this backdrop, we
stated that we intend to move
deliberately and carefully because we
recognize the complexities of
calculating a reliable and valid measure
of value that could be used to
differentiate payment.
Notwithstanding this caution, we
have used the 2010 Physician Feedback
Program reports to help develop
attribution methodologies for physicians
and physician groups and to use them
as a mechanism to gain feedback into
the value modifier and its
methodologies. In addition, we have
standardized Medicare costs and
applied the HCC risk adjustment model
to physician per capita costs in these
reports. As discussed previously, we
will be convening public events to
further explore these issues and to
gather stakeholder input based on these
reports and the methodologies we have
applied.
We also will use the next several
months, before the 2013 physician fee
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schedule rulemaking process begins, to
explore various ways to develop
composites of cost and quality that
could be used in the value modifier and
to hold listening sessions and engage in
other activities with stakeholders to gain
input into the value modifier. We will
continue our work to implement the
statutory directives and plan to propose
in next year’s physician fee schedule
rulemaking a methodology for the value
modifier.
Comment: Many commenters stated
that CMS should focus the value
modifier in 2015 and 2016 on large
integrated group practices. Some
commenters supported that CMS focus
initially on cost and quality outliers.
Other commenters recommended that
we focus on physicians who treat
patients with the most prevalent and
costly conditions. Other commenters
suggested that because the proposed
quality of care measures focused on
chronic conditions, we should apply the
value modifier starting in 2015 to
physicians treating these conditions.
Response: We thank these
commenters for their comments and
will address these issues in future
rulemaking.
c. Initial Performance Period
Section 1848(p)(4)(B)(ii)(I) of the Act
requires the Secretary to specify an
initial performance period for the
application of the value modifier with
respect to 2015. We proposed that the
initial performance period be the full
calendar year 2013, that is, January 1,
2013 through December 31, 2013 (76 FR
42913). The value modifier that would
apply to items and services furnished by
specific physicians and groups of
physicians under the 2015 physician fee
schedule would be based on
performance during 2013. We proposed
this performance period because some
claims for 2013 (which could be used in
cost or quality measures) may not be
fully processed until 2014. As such, we
will need adequate lead time to collect
performance data, assess performance,
and construct and compute the value
modifier during 2014 so that it can be
applied to specific physicians starting
January 1, 2015, as required by statute.
As we have done in other payment
systems, we plan to use claims that are
paid within a specified time period,
such as, 90 days after 2013, for
assessment of performance and
application of the value modifier for
2015. We will propose the specific cutoff period as part of the more detailed
methodology for computation and
application of the value modifier in
future rulemaking(s). We requested
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comment on this proposed performance
period.
Comment: Commenters strongly
opposed the use of 2013 as the initial
performance period given ‘‘the myriad
methodological issues involved.’’ Many
commenters stated it was unfair to have
the initial performance period begin
January 1, 2013 before the methodology
to compute the value modifier is
finalized in November 2013. Some
commenters suggested that the gap
between the performance period and the
payment adjustment period was too
long. Some commenters suggested we
were not required to use a full year as
the performance period. Other
commenters suggested that ‘‘unless and
until there is evidence that it is possible
to accurately measure value without
penalizing those physicians who treat
the most difficult patients,’’ CMS should
not move forward with specifying a
performance year. Other commenters
suggested CMS designate calendar year
2015 as a ‘‘practice year’’ to allow for
additional physician acceptance of the
methodology we use to calculate the
value modifier.
Response: Section 1848(p)(4)(B)(iii) of
the Act requires us to apply the
payment modifier to specific physicians
and physician groups the Secretary
determines appropriate for items and
services furnished beginning January 1,
2015. We proposed calendar year 2013
as the initial performance period
because it provides physicians with
substantial lead time to participate in
the Physician Quality Reporting System
and the EHR Incentive Program and to
begin to take the necessary steps to
report quality and use the results to
improve the quality of their care.
Indeed, there is still an opportunity to
participate in the Physician Quality
Reporting System program for the 2011
program year, two years before the
initial performance period for the value
modifier. As we discussed above, we do
not seek to evaluate individual
physicians on each of the quality of care
measures used in the value modifier,
but rather assess physician performance
using quality of care measures for the
types of care they provide. We strongly
encourage physicians to participate in
the Physician Quality Reporting System
program and the EHR Incentive Program
sooner rather than later and to choose to
report quality of care measures that best
reflect their practice and patient
population. Although we have not yet
proposed the value modifier
methodology, our primary interest at
this point is to increase the quality of
care for Medicare beneficiaries. We note
that we also plan to propose a value
modifier in rulemaking during 2012,
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prior to the initial performance period.
Thus, we believe it is reasonable to
encourage physicians to report
appropriate quality measures well in
advance and irrespective of the exact
value modifier methodology at this
time.
We explored using 2015 as the
performance period and making
retroactive adjustments in 2016 to
claims paid for care furnished in 2015.
This retroactive approach would require
us to reprocess all 2015 claims so that
each claim shows actual amounts paid.
Additionally, retroactive adjustments
affect beneficiary cost sharing amounts,
which also would need to be adjusted
retrospectively. Requiring physicians to
collect or refund small cost sharing
amounts is operationally complex and
confusing for beneficiaries. These same
two issues arise if we were to use
calendar year 2014 as the performance
period for the 2015 payment adjustment
year.
We also examined whether we could
use an abbreviated period (such as, 6
months) or a period that crossed years
(such as, July 1–June 30) as the
performance period. The former
approach is unlikely to yield sufficient
volume of cases to develop reliable
measures for individual physicians and
the latter approach is inconsistent with
reporting periods currently established
for the Physician Quality Reporting
System and the EHR Incentive Program.
Despite these challenges, we are still
seeking other ways to close the gap
between the performance period and the
payment adjustment period. In the
interim, however, we are finalizing our
proposal that calendar year 2013 be the
initial performance period, because it
aligns with the Physician Quality
Reporting System and the EHR
Incentive Program and because the
alternatives are more onerous to
physicians and beneficiaries than our
original proposal. We will reexamine
the initial performance period in future
rulemakings as we seek to provide more
timely feedback to physicians.
d. Other Issues
We also requested comment on two
issues related to the development of the
value modifier, although we did not
make proposals to address either issue
in the proposed rule. First, section
1848(p)(5) of the Act requires the
Secretary, as appropriate, to apply the
value-based modifier in a manner that
promotes systems-based care. We sought
comment on how we might determine
the scope of systems-based care and
how best to promote it in applying the
value modifier. Second, section
1848(p)(6) of the Act requires the
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Secretary in applying the value
modifier, as appropriate, to take into
account the special circumstances of
physicians or groups of physicians in
rural areas and other underserved
communities. We requested comment
on how we should identify physicians
or groups of physicians in rural areas
and other underserved communities, the
specific special circumstances they face,
and once identified, how these special
circumstances should be taken into
account for purposes of applying the
value modifier (76 FR 42914).
Comment: CMS received many
comments promoting systems-based
care. These commenters suggested that
applying the value modifier at the group
level reinforced systems-based care.
Hospital-based physicians stated that
aligning the value modifier and the
hospital value based purchasing
program on both cost and quality would
encourage systems-based care. Another
commenter suggested that using a value
modifier that would apply to all
physicians in a specific region would
encourage systems-based care. Other
commenters indicated that
establishment of medical homes and
‘‘Independence at Home’’ for the sickest,
most costly patients encouraged
systems-based care. Commenters stated
that these two programs emphasize
coordination of care by providing
services early before beneficiary medical
conditions become more serious and
costly to treat. Other commenters
supported the concept of a coordinated
surgical home model. Another
commenter encouraged CMS to work
with specialty societies to define
systems-based care for the purpose of
the value modifier.
Response: We thank these
commenters for their comments and
will take them into account as we
progress in our thinking of ways to
promote systems-based care in the value
modifier program, and particularly how
to incorporate care transition/
coordination measures into the program.
Comment: One commenter said we
should expand our inquiry beyond
identifying rural physicians and
examine whether beneficiaries in rural
areas have sufficient access to care by
looking at the breadth and level of
services available to them. This
commenter also emphasized the
importance of mid-level providers such
as nurse practitioners and physician
assistants and that the value modifier
should apply to them. Commenters
stressed that rural providers are already
overworked and the value modifier
should be simple and not require
additional staff or technology. One
commenter suggested we work with the
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Veterans Administration due to their
extensive experience and analytic
capabilities. CMS also received
comment to consult and work with the
Indian Health Service to understand the
organizational structures of tribal
hospitals and clinics. One commenter
also suggested that a modifier that
reflects a regional practice mode would
‘‘facilitate measurement in rural and
underserved communities because it
emphasizes a broader perspective and
one that is more relevant for providers
and patients.’’
Response: We thank these
commenters for their input and will take
these comments and the information
provided into account as we progress
with the methodology for the value
modifier.
3. Physician Feedback Program
Section 1848(n) requires us to provide
confidential reports to physicians that
measure the resources involved in
furnishing care to Medicare
beneficiaries. Section 1848(n)(1)(A)(iii)
of the Act also authorizes us to include
information on the quality of care
furnished to Medicare beneficiaries by a
physician or group of physicians. We
have completed two phases of the
Physician Feedback Program. By the
end of 2011, we intend to implement
Phase III of the Physician Feedback
Program by providing reports on both
resource use and quality measures to
physician groups that participated in
the Group Practice Reporting Option
(GPRO–1) in 2010 and to physicians
practicing in the following States: Iowa,
Kansas, Missouri, and Nebraska. As we
explained previously, many of the
methodological issues that we are
addressing in the Physician Feedback
Program reports will assist us as we
implement the value modifier.
a. Alignment of Physician Quality
Reporting System Quality of Care
Measures With the Physician Feedback
Reports
We explained in the proposed rule
that we are using the quality measures
reported in the Physician Quality
Reporting System in the Physician
Feedback Program reports that we
disseminate this year (76 FR 42903). We
took this step because use of Physician
Quality Reporting System measures
aligns both quality initiatives and
reduces potential program
inconsistencies, ensures we do not
measure the same clinical process or
outcome using different data sources or
methodologies, and does not place new
reporting burdens on physicians.
Although we did not make any
proposals in this area, we requested
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comment on using the performance data
in the Physician Quality Reporting
System in the Physician Feedback
Program.
Comment: Most commenters
supported using the Physician Quality
Reporting System’s quality measures in
the Physician Feedback Program
reports. These commenters frequently
also requested a closer alignment of all
of our physician quality improvement
programs. A number of commenters,
including hospital-based physicians
such as hospitalists, surgeons, and
certain specialists and sub-specialists,
noted that the Physician Quality
Reporting System measures did not
include measures to assess their
performance or apply to elements of
their practice. Many commenters
expressed interest in working with us to
identify the measures that captured the
seminal elements of their practice.
Response: We plan to continue to use
the quality of care measures reported in
the Physician Quality Reporting System
to reduce physician burden, align
physician reporting and support a
common infrastructure for the
measurement of physician value. We
appreciate the commenter’s interest in
working with us as we refine the
Physician Feedback Program to make
the reports more meaningful and
relevant to more physicians.
b. 2010 Physician Group and Individual
Reports Disseminated in 2011
We described in the proposed rule
how we intended to create physician
feedback reports for the 35 large medical
group practices (each with 200 or more
physicians) that chose to participate in
the Physician Quality Reporting System
Group Practice Reporting Option
(GPRO–1) in 2010 (76 FR 42903). In
addition, we described how we planned
to disseminate Physician Feedback
Program reports to individual
physicians paid under the Physician Fee
Schedule within four States: Iowa,
Kansas, Missouri, and Nebraska (76 FR
42904). We explained that we chose
these four States because the Medicare
Administrative Contractor serving these
States could assist us in emailing these
reports to a substantial number of
physicians because of its robust
electronic communications
infrastructure.
We stated in the proposed rule that
deciding which physician(s) is/are
responsible for the care of which
beneficiaries is an important aspect of
measurement (76 FR 42907). When
attributing beneficiary cost information
to physicians, we stated that we must
balance between costs for delivered
services that are within the physician’s
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control and costs for delivered services
that are not within their control. We
recognized that attribution rules have
the potential to alter incentives
regarding how physicians coordinate
and deliver care to beneficiaries and
seek to encourage better care
coordination and accountability for
patient outcomes. In addition,
determining how to make relevant
comparisons of physicians to a standard
or to their peers is also an important
policy aspect of the Physician Feedback
Program.
In light of these issues, we indicated
that the individual physician reports
that we are disseminating this year will
allow more Medicare beneficiaries to be
matched to physicians for purposes of
assessing the quality of care furnished
and the associated resources. In
addition, we indicated that the reports
will stratify physicians by specialty and
by the conditions they treat, which
allow both cost and clinical measures to
reflect procedures and services that best
portray physician practice patterns.
Finally, we stated we intended to
examine whether to provide reports to
groups of physicians who submit
Medicare claims under a single tax
identification number (TIN) to see if we
can provide feedback reports that cover
more physicians. Although we did not
make any proposals in this area, we
requested comment on these and any
other issues to ensure that the future
Physician Feedback Program reports
provide meaningful and actionable
information.
Comment: Many commenters agreed
with our examination of alternative
attribution methods to assign
beneficiaries that would allow increased
numbers of beneficiaries to be matched
to physicians but they also questioned
our ability to do so. Many commenters
cited the recent Government
Accountability Office (GAO) report,
‘‘Medicare Physician Feedback program:
CMS Faces Challenges with
Methodology and Distribution of
Physician Reports,’’ that described the
challenges involved with developing
and disseminating physician feedback
reports.3 In particular, the GAO
recommended that we use
methodological approaches that
increase the number of physicians
eligible to receive a report, such as: (1)
Multiple provider attribution methods,
which could also enhance credibility of
the reports with physicians; and (2)
distributing feedback reports that
3 Medicare Physician Feedback Program: CMS
Faces Challenges with Methodology and
Distribution of Physician Reports, GAO–11–720
(August 12, 2011), available at https://www.gao.gov/
new.items/d11720.pdf
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include only resource use information,
if quality information is unavailable.
Response: We worked closely with
the GAO in its review of the Physician
Feedback Program by providing them
our plans to improve and expand the
program, and we concur with their
recommendations to:
• Use methodological approaches that
increase the number of physicians
eligible to receive a report, such as (a)
multiple provider attribution methods,
which could also enhance credibility of
the reports with physicians and (b)
distributing feedback reports that
include only resource use information,
if quality information is unavailable.
• Conduct statistical analyses of the
impact of key methodological decisions
on reliability.
• Identify factors that may have
prevented physicians from accessing
their reports and, as applicable, develop
strategies to improve the process for
distributing reports and facilitating
physicians’ access to them.
• Obtain input from a sample of
physicians who received feedback
reports on the usefulness and credibility
of the performance measures contained
in the reports and consider using this
information to revise future reports.
As we discussed with GAO, we are
taking steps this year to address many
of the issues that they raised regarding
the first two phases of the Physician
Feedback program.
For example, on September 26, 2011,
we distributed physician reports to the
physician groups that participated in
the Group Reporting Option in the
Physician Quality Reporting System in
2010. These reports represent the first
time performance on a wide-range of
quality of care and cost measures can be
viewed in the same report for Medicare
beneficiaries in large group practices
across the country. As recommended by
the GAO, we invited all report
recipients to provide us input on the
usefulness and credibility of the
performance measures contained in the
report so that we could improve the
reports for future years. We will be
releasing publicly the general findings
from these reports. This analysis will
include statistical analysis of the impact
of key methodological decisions on
reliability that the GAO recommended
that we conduct.
In addition, the reports that we are
producing for individual physicians in
Iowa, Kansas, Missouri, and Nebraska
will contain quality performance data
on the 28 administrative claims-based
measures described in the proposed rule
(76 FR 42904 through 42907) for all
physicians and performance on the
Physician Quality Reporting System
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measures for those physicians who
satisfactorily reported in 2010. For the
cost measures, we will categorize
physicians’ Medicare fee for service
patients based on the level of care
provided to them in 2010 as measured
by outpatient Evaluation and
Management (‘‘E/M’’) office visits and
total professional costs. Using this
approach, we expect to be able to
attribute all Medicare beneficiaries who
were enrolled in Medicare for at least
one full year to physicians practicing in
those four States during 2010.
This approach addresses the GAO’s
recommendations to use methodological
approaches to increase the number of
physicians eligible to receive a report.
We will invite report recipients to
provide us input to increase the
usefulness and credibility of future
individual physician reports and we
will be conducting statistical analysis of
the impact of our methodological
decisions on reliability as recommended
by the GAO. In addition, we have taken
steps this year to overcome the barriers
that have prevented physicians from
accessing their reports in the past and
we will be working on developing
future strategies to improve the process
for distributing the reports in the future,
as recommended by the GAO.
Comment: Many commenters
supported measuring physician
performance and creating peer groups
for comparisons based on specialty or
even more narrowly, subspecialty. By
contrast, other commenters supported
measuring physician performance and
creating peer groups for comparisons by
patient condition. In either case, many
commenters stated that without a
method to identify and compare
physicians caring for the highest acuity
patients, we might be unfairly biasing
any cost comparisons or encouraging
physicians to avoid caring for the most
complex Medicare patients.
Commenters varied in their support of
group versus individual physician level
reporting. Several commenters cited the
need for large enough numbers of cases
to apply confidence intervals and noted
that reliable results were critical to
acceptance of the Physician Feedback
Program reports.
Response: Using the data from the
2010 group and individual physician
feedback reports disseminated in 2011,
we plan to evaluate the reliability for
quality of care and cost measures and
comparison groups included in the
reports. We will use this analysis to
inform how we move forward with the
Physician Feedback Program to ensure
that they contain valid and reliable
measures that are fair and meaningful to
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physicians’ efforts to improve quality
while reducing costs.
J. Physician Self-Referral Prohibition:
Annual Update to the List of CPT/
HCPCS Codes
1. General
Section 1877 of the Act prohibits a
physician from referring a Medicare
beneficiary for certain designated health
services (DHS) to an entity with which
the physician (or a member of the
physician’s immediate family) has a
financial relationship, unless an
exception applies. Section 1877 of the
Act also prohibits the DHS entity from
submitting claims to Medicare or billing
the beneficiary or any other entity for
Medicare DHS that are furnished as a
result of a prohibited referral.
Section 1877(h)(6) of the Act and
§ 411.351 of our regulations specify that
the following services are DHS:
• Clinical laboratory services.
• Physical therapy services.
• Occupational therapy services.
• Outpatient speech-language
pathology services.
• Radiology services.
• Radiation therapy services and
supplies.
• Durable medical equipment and
supplies.
• Parenteral and enteral nutrients,
equipment, and supplies.
• Prosthetics, orthotics, and
prosthetic devices and supplies.
• Home health services.
• Outpatient prescription drugs.
• Inpatient and outpatient hospital
services.
2. Annual Update to the Code List
a. Background
In § 411.351, we specify that the
entire scope of four DHS categories is
defined in a list of CPT/HCPCS codes
(the Code List), which is updated
annually to account for changes in the
most recent CPT and HCPCS
publications. The DHS categories
defined and updated in this manner are
as follows:
• Clinical laboratory services.
• Physical therapy, occupational
therapy, and outpatient speech-language
pathology services.
• Radiology and certain other imaging
services.
• Radiation therapy services and
supplies.
The Code List also identifies those
items and services that may qualify for
either of the following two exceptions to
the physician self-referral prohibition:
• Dialysis-related drugs furnished in
or by an ESRD facility (§ 411.355(g)).
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• Preventive screening tests,
immunizations, or vaccines
(§ 411.355(h)).
The definition of DHS at § 411.351
excludes services that are reimbursed by
Medicare as part of a composite rate
(unless the services are specifically
identified as DHS and are themselves
payable through a composite rate, such
as home health and inpatient and
outpatient hospital services). Effective
January 1, 2011, EPO and other dialysisrelated drugs furnished by an ESRD
facility (except drugs for which there are
no injectable equivalents or other forms
of administration) are being paid under
the ESRD PPS promulgated in the final
rule published on August 12, 2010 in
the Federal Register (75 FR 49030).
Drugs for which there are no injectable
equivalents or other forms of
administration will be payable under
the ESRD PPS beginning January 1,
2014.
The Code List was last updated in
Addendum J of the CY 2011 PFS final
rule with comment period (75 FR 73831
through 73841) and revised in a
subsequent correction notice (76 FR
1670).
b. Response to Comments
We received no public comments
relating to the Code List that became
effective January 1, 2011.
c. Revisions Effective for 2012
The updated, comprehensive Code
List effective January 1, 2012, is listed
as Addendum J in this final rule with
comment period and is available on our
Web site at https://www.cms.gov/
PhysicianSelfReferral/
40_List_of_Codes.asp#TopOfPage.
Additions and deletions to the Code
List conform the Code List to the most
recent publications of CPT and HCPCS
and to changes in Medicare coverage
policy and payment status.
The following Tables 83 and 84,
identify the additions and deletions,
respectively, to the comprehensive Code
List that become effective January 1,
2012. Tables 83 and 84 also identify the
additions and deletions to the list of
codes used to identify the items and
services that may qualify for the
exception in § 411.355(g) (regarding
dialysis–related outpatient prescription
drugs furnished in or by an ESRD
facility) and in § 411.355(h) (regarding
preventive screening tests,
immunizations, and vaccines).
In Table 82, we specify additions that
reflect new CPT and HCPCS codes that
become effective January 1, 2012, or that
became effective since our last update.
We also include additions that reflect
changes in Medicare coverage policy or
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96110 from the category of ‘‘physical
therapy, occupational therapy, and
outpatient speech-language pathology
services’’ because the code was revised.
It has been replaced by HCPCS code
G0451, which is listed in Table 82.
We will consider comments regarding
the codes listed in 83 and 84. Comments
will be considered if we receive them by
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the date specified in the ‘‘DATES’’
section of this final rule with comment
period. We will not consider any
comment that advocates a substantive
change to any of the DHS defined in
§ 411.351.
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payment status that become effective
January 1, 2012, or that became effective
since our last update.
Table 83 reflects the deletions
necessary to conform the Code List to
the most recent publications of the CPT
and HCPCS, and to changes in Medicare
coverage policy and payment status. In
addition, we are deleting CPT code
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K. Technical Corrections
inpatients of a hospital or a CAH or
SNF.’’
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1. Outpatient Speech-Language
Pathology Services: Conditions and
Exclusions
We proposed and are now finalizing
a technical correction to the heading of
the condition of coverage at § 410.62(b)
for outpatient speech-language
pathology services. The heading was
inadvertently changed in the course of
rulemaking for CY 2009 when a new
paragraph was added at § 410.62(c) to
recognize speech-language pathologists
in private practice. The section heading
at § 410.62(b) currently reads ‘‘Special
provisions for services furnished by
speech-language pathologists in private
practice.’’ We did not receive public
comments on our proposal to make a
technical correction to § 410.62(b), as
such, we are finalizing the change to
reinstate the correct heading at
§ 410.62(b) to read ‘‘Condition for
coverage of outpatient speech-language
pathology services furnished to certain
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2. Outpatient Diabetes Self-Management
Training and Diabetes Outcome
Measurements
We proposed to make two technical
corrections to Subpart H of the
regulations for Outpatient Diabetes SelfManagement Training and Diabetes
Outcome Measurements at § 410.140 to
the definition of ‘‘deemed entity’’ and at
§ 410.141(b)(1) entitled ‘‘training
orders’’. We did not receive public
comments on either proposal; as a result
we are finalizing both of these technical
corrections as proposed and discussed
below.
a. Changes to the Definition of
Deemed Entity
We proposed and are now finalizing
the following technical corrections to
the definition of ‘‘deemed entity’’ in
§ 410.140 to—
• Remove the following phrases to
clarify the purpose of the reference to an
approved entity:
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++ ‘‘[B]y CMS to furnish and receive
Medicare payment for the training’’.
++ ‘‘Upon being approved’’.
++ ‘‘CMS refers to this entity as an
‘‘approved entity’’’’.
• Remove an incorrect reference to
§ 410.141(e) and replacing it with
§ 410.145(b).
The final revisions read as follows:
Deemed entity means an individual,
physician, or entity accredited by an
approved organization, but that has not
yet been approved by CMS under
§ 410.145(b) to furnish training.
b. Changes to the Condition of Coverage
Regarding Training Orders
We proposed and are now finalizing
the following technical correction to
§ 410.141(b)(1) entitled ‘‘training
orders’’ to:
• Remove the cross-reference
‘‘§ 410.32(a)’’ and adding the crossreference ‘‘§ 410.32(a)(2)’’.
• Remove the term ‘‘it’’ and adding
the phrase ‘‘the training’’ in its place.
The final revisions read as follows:
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Training orders. Following an
evaluation of the beneficiary’s need for
the training, the training is ordered by
the physician (or qualified
nonphysician practitioner) (as defined
in § 410.32(a)(2)) treating the
beneficiary’s diabetes.
3. Practice Expense Relative Value Units
(RVUs)
In the CY 2012 PFS proposed rule (76
FR 42920), we proposed technical
corrections to the regulation at
§ 414.22(b) to include examples of the
settings in which the facility or
nonfacility practice expense (PE) RVUs
are applied and to clarify that the
settings list was not exhaustive. We
proposed adding ‘‘hospice’’ after
‘‘community mental health center’’
under § 414.22(b)(5)(i)(A) as a setting in
which facility PE RVUs apply. We
proposed revising the language under
§ 414.22(b)(5)(i)(B) to include
‘‘comprehensive outpatient
rehabilitation facility (CORF)’’ as a
setting in which nonfacility PE RVUs
are applied, and we proposed to revise
the description of outpatient therapy
services.
Comment: We received one comment
from an association representing
speech-language pathologists and
audiologists requesting that we add
audiology services in our proposed
revision of paragraph (b)(5)(i)(C) of the
regulation at § 414.22(b) that specifies
the nonfacility practice expense RVUs
are always applied to outpatient therapy
services and CORF services billed under
the physician fee schedule. Following
this logic, the commenters requested
that we remove the facility practice
expense RVUs from 15 of the CPT codes
on the Audiology Code list at https://
www.cms.gov/PhysicianFeeSched/ and
always pay for audiology services at the
nonfacility practice expense RVU
amount.
Response: Our proposed revision to
the regulation at § 414.22(b)(5)(i)(C) was
merely a technical change to reflect
more accurately our current policy to
apply the nonfacility PE RVUs for
outpatient therapy and CORF services
billed under the PFS, and to add a
parenthetical description of outpatient
therapy services. We did not propose to
make any changes in our current policy
regarding the settings in which the
facility or nonfacility PE RVUs are
applied. Under sections 1833(a)(8) and
(9), and 1834(k) of the Act, payment for
all outpatient therapy services,
including physical therapy,
occupational therapy, speech-language
pathology and CORF services, is made
at the ‘‘applicable fee schedule amount’’
which is the payment amount
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determined under the PFS. Audiology
services are not included within the
definition of outpatient therapy services
subject to this payment basis. As a
result, we will continue to pay for
audiology services under the physician
fee schedule, applying nonfacility or
facility PE RVUs, as appropriate based
on the setting in which services are
furnished.
We are finalizing the following
technical corrections to the regulation at
§ 414.22(b):
• In paragraphs (b)(5)(i)(A) and (B),
we—
++ Included additional examples of
the settings in which the facility or
nonfacility practice expense (PE) RVUs
are applied, respectively; and
++ Clarified that the lists of settings
are not exhaustive; and amended these
lists to include additional place of
service examples.
• In paragraph (b)(5)(i)(A) we added
‘‘hospice’’ to the list of places of service
after ‘‘community mental health
center.’’
• In paragraph (b)(5)(i)(B), we—
++ Revised the language to be more
consistent with (b)(5)(i)(A) and to
include the ‘‘comprehensive outpatient
rehabilitation facility (CORF)’’ as a place
of service example; and
++ Clarified this provision by
removing the text regarding the use of
the nonfacility PE RVUs for services in
‘‘ * * * a facility or institution other
than the hospital, skilled nursing
facility, community mental health
center, or ASC’’ because this phrase
does not accurately reflect the places of
service where the nonfacility PE RVUs
are applied.
• In paragraph (b)(5)(i)(C), we—
++ Revised the paragraph
introduction by adding ‘‘and CORF’’
after ‘‘outpatient therapy’’ and before
‘‘services’’ and, to more accurately
define the term ‘‘outpatient therapy
services,’’ to add ‘‘(including physical
therapy, occupational therapy and
speech-language pathology services)’’
after ‘‘therapy services’’ and before
‘‘CORF services billed under * * *’’.
The final revisions to
§ 414.22(b)(5)(i)(A), (B), and (C) read as
follows:
(A) Facility practice expense RVUs.
The facility practice expense RVUs
apply to services furnished to patients
in places of service including, but not
limited to, a hospital, a skilled nursing
facility, a community mental health
center, a hospice, or an ambulatory
surgical center.
(B) Nonfacility practice expense
RVUs. The nonfacility practice expense
RVUs apply to services furnished to
patients in places of service including,
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but not limited to, a physician’s office,
the patient’s home, a nursing facility, or
a comprehensive outpatient
rehabilitation facility (CORF).
(C) Outpatient therapy and CORF
services. Outpatient therapy services
(including physical therapy,
occupational therapy, and speechlanguage pathology services) and CORF
services billed under the physician fee
schedule are paid using the nonfacility
practice expense RVUs.
VII. Waiver of Proposed Rulemaking
and Collection of Information
Requirements
A. Waiver of Proposed Rulemaking and
Delay in Effective Date
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
We utilize HCPCS codes for Medicare
payment purposes. The HCPCS is a
national drug coding system comprised
of Level I (CPT) codes and Level II
(HCPCS National Codes) that are
intended to provide uniformity to
coding procedures, services, and
supplies across all types of medical
providers and suppliers. Level I (CPT)
codes are copyrighted by the AMA and
consist of several categories, including
Category I codes which are 5-digit
numeric codes, and Category III codes
which are temporary codes to track
emerging technology, services, and
procedures. The AMA issues an annual
update of the CPT code set each Fall,
with January 1 as the effective date for
implementing the updated CPT codes.
The HCPCS, including both Level I and
Level II codes, is similarly updated
annually on a CY basis. Annual coding
changes are not available to the public
until the Fall immediately preceding the
annual January update of the PFS.
Because of the timing of the release of
these new codes, it is impracticable for
us to provide prior notice and solicit
comment on these codes and the RVUs
assigned to them in advance of
publication of the final rule that
implements the PFS. Yet, it is
imperative that these coding changes be
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accounted for and recognized timely
under the PFS for payment because
services represented by these codes will
be provided to Medicare beneficiaries
by physicians during the CY in which
they become effective. Moreover,
regulations implementing HIPAA (42
CFR parts 160 and 162) require that the
HCPCS be used to report health care
services, including services paid under
the PFS. We assign interim RVUs to any
new codes based on a review of the
AMA RUC recommendations for valuing
these services. We also assign interim
RVUs to certain codes for which we did
not receive specific AMA RUC
recommendations, but that are
components of new combined codes.
We set interim RVUs for the component
codes in order to conform them to the
value of the combined code. Finally, we
assign interim RVUs to certain codes for
which we received AMA RUC
recommendations for only one
component (work or PE) but not both.
By reviewing these AMA RUC
recommendations for the new codes, we
are able to assign RVUs to services
based on input from the medical
community and to establish payment for
them, on an interim basis, that
corresponds to the relative resources
associated with furnishing the services.
We are also able to determine, on an
interim final basis, whether the codes
will be subject other payment policies.
If we did not assign RVUs to new codes
on an interim basis, the alternative
would be to either not pay for these
services during the initial CY or have
each Medicare contractor establish a
payment rate for these new codes. We
believe both of these alternatives are
contrary to the public interest,
particularly since the AMA RUC process
allows for an assessment of the
valuation of these services by the
medical community prior to our
establishing payment for these codes on
an interim basis. Therefore, we believe
it would be contrary to the public
interest to delay establishment of fee
schedule payment amounts for these
codes.
For the reasons previously outlined in
this section, we find good cause to
waive the notice of proposed
rulemaking for the interim RVUs for
selected procedure codes identified in
Addendum C and to establish RVUs for
these codes on an interim final basis.
We are providing a 60-day public
comment period.
Section II.C. of this final rule with
comment period discusses the
identification and review of potentially
misvalued codes by the AMA RUC, as
well as our review and decisions
regarding the AMA RUC
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recommendations. Similar to the AMA
RUC recommendations for new and
revised codes previously discussed, due
to the timing of the AMA RUC
recommendations for the potentially
misvalued codes, it was impracticable
for CMS to solicit public comment
regarding specific proposals for revision
prior to this final rule with comment
period. We believe it is in the public
interest to implement the revised RVUs
for the codes that were identified as
misvalued, and that have been reviewed
and re-evaluated by the AMA RUC, on
an interim final basis for CY 2012. The
revisions of RVUs for these codes will
establish a more appropriate payment
that better corresponds to the relative
resources associated with furnishing
these services. A delay in implementing
revised values for these misvalued
codes would not only perpetuate the
known misvaluation for these services,
it would also perpetuate a distortion in
the payment for other services under the
PFS. Implementing the changes now
allows for a more equitable distribution
of payments across all PFS services. We
believe a delay in implementation of
these revisions would be contrary to the
public interest, particularly since the
AMA RUC process allows for an
assessment of the valuation of these
services by the medical community
prior to the AMA RUC’s
recommendation to CMS. For the
reasons previously described, we find
good cause to waive notice and
comment procedures with respect to the
misvalued codes identified in Tables 19
through 22 and to revise RVUs for these
codes on an interim final basis. We are
providing a 60-day public comment
period.
We ordinarily provide a 60-day delay
in the effective date of the provisions of
a rule in accordance with the
Administrative Procedure Act (APA) (5
U.S.C. 553(d)), which requires a 30-day
delayed effective date, and the
Congressional Review Act (5 U.S.C.
801(a)(3)), which requires a 60-day
delayed effective date for major rules.
However, we can waive the delay in the
effective date if the Secretary finds, for
good cause, that the delay is
impracticable, unnecessary, or contrary
to the public interest, and incorporates
a statement of the finding and the
reasons in the rule issued (5 U.S.C.
553(d)(3); 5 U.S.C. 808(2)).
B. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
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submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
Section 4103 of the Affordable Care
Act expanded Medicare Part B to
include coverage for an annual wellness
visit providing personalized prevention
plan services (hereinafter referred to as
an annual wellness visit) in section
1861(s)(2)(FF) of the Act, effective
January 1, 2011. In 42 CFR 410.15, we
adopted the components of the annual
wellness visit, consistent with the
statutory elements described in section
1861(hhh)(2) of the Act. The first and
subsequent annual wellness visits, as
defined in 42 CFR 410.15(a), are meant
to represent a beneficiary visit focused
on prevention. Among other things, the
annual wellness visit encourages
beneficiaries to obtain the preventive
services covered by Medicare that are
appropriate for them. First and
subsequent annual wellness visits also
include elements that focus on the
furnishing of personalized health advice
and referral, as appropriate, to health
education, preventive counseling
services, programs aimed at improving
self-management, and community-based
lifestyle interventions.
Medicare beneficiaries will likely
need assistance from physician office
staff in completing an HRA as
envisioned in the CDC interim
guidance. The physician office staff time
for assisting a beneficiary in completing
an HRA is estimated to be 10 minutes
(.16 hours) for a first annual wellness
visit. During subsequent annual
wellness visits, we would typically
expect that the HRA would be updated,
making physician staff time estimated at
5 minutes (.08 hours). The number of
beneficiaries that received the annual
wellness visit during the first 10 months
of 2011 was 1.6 million. Based on this
information, the estimated hour burden
for the initial HRA is 256,000 total
hours. However, for purposes of OMB
review and approval, the average annual
burden which accounts both the initial
HRA and subsequent HRAs is 200,000
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hours. An average burden of 7.5 minutes
(0.125 hours) multiplied by 1.6 million
beneficiaries.
The final rule with comment period
imposes collection of information
requirements as outlined in the
regulation text and specified in various
section of this final rule with comment
period. However, this final rule with
comment period also makes reference to
several associated information
collections that are not discussed in the
regulation text contained in this
document. The following is a discussion
of these information collections, some of
which have already received OMB
approval.
1. Part B Drug Payment
The discussion of average sales price
(ASP) issues in section VI.A.1 of this
final rule with comment period pertains
to payment for Medicare Part B drugs
and biologicals under the ASP
methodology. Drug manufacturers are
required to submit ASP data to us on a
quarterly basis. The ASP reporting
requirements are set forth in section
1927(b) of the Act. In order to facilitate
more accurate and consistent ASP data
reporting from manufacturers, we
proposed the following:
• To revise existing reporting fields
and add new fields to the Addendum A
template.
• To add a macro to the Addendum
A template that will allow
manufacturers to validate the format of
their data prior to submission.
• To maintain a list of HCPCS codes
for which manufacturer’s report ASPs
for NDCs on the basis of a specified
unit.
• A clarification to existing regulation
text at § 414.802. Current regulation text
states that ‘‘Unit means the product
represented by the 11 digit National
Drug Code.’’ We proposed to update the
definition to account for situations
when an alternative unit of reporting
must be used.
Additionally, we will also be revising
our instructions for the reporting of
dermal grafting products in a user guide
available on the ASP Web site at: https://
www.cms.gov/
McrPartBDrugAvgSalesPrice/.
The burden associated with this
requirement is the time and effort
required by manufacturers of Medicare
Part B drugs and biologicals to calculate,
record, and submit the required data to
CMS. The Addendum A template is
currently approved under OMB control
number 0938–0921. For the first year,
we estimate that collection of the
additional data elements will take
approximately 2 additional hours for
each submission of data, or 12 hours per
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response, at a cost of $252 per response.
Based on the current number of
respondents, we estimate that this
requirement will affect approximately
180 manufacturers. Since manufacturers
will respond 4 times per year, we
estimate that, on an annual basis, the
annual number of responses will be 720
(180 manufacturers × 4 responses) and
the total annual hours burden will be
8,640 hours (720 annual responses × 12
annual hours per response). Please note
that this is a corrected annual hour
burden estimate; the 34,560 hour
estimate in the proposed rule (76 FR
42921) resulted from a mathematical
error. We estimate the annual cost
burden to be $181,440 ($252 per
response × 720 responses). Once
manufacturers adjust to the changes
associated with electronic reporting
after the first year, we anticipate that the
burden estimate will decrease.
We invited comments on this burden
analysis, including the underlying
assumptions used in developing our
burden estimates and received no
comments. We have corrected a
mathematical error associated with the
total annual burden which decreases the
hourly burden. The cost estimate
remains unchanged. Operational aspects
and comments regarding the ASP
template were discussed in section
VI.A.3 of this rule where we finalized
our proposal to amend the Addendum
A template, including the use of a data
validation macro with the expansion of
the ‘‘Alternate ID’’ field. A companion
Users’ Guide, and other documents will
be posted on the CMS ASP Web site.
2. The Physician Quality Reporting
System
Section VI.F.1. of this final rule with
comment period discusses the
background of the Physician Quality
Reporting System, provides information
about the measures and reporting
mechanisms that will be available to
eligible professionals and group
practices who choose to participate in
the 2012 Physician Quality Reporting
System, and the criteria for satisfactory
reporting in 2012.
a. Estimated Participation in the 2012
Physician Quality Reporting System
With respect to satisfactory
submission of data on quality measures
by eligible professionals, eligible
professionals include physicians, other
practitioners as described in section
1842(b)(18)(c) of the Act, physical and
occupational therapists, qualified
speech-language pathologists, and
qualified audiologists. Eligible
professionals may choose whether to
participate and, to the extent they
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satisfactorily submit data on quality
measures for covered professional
services, they can qualify to receive an
incentive payment. To qualify to receive
an incentive payment for 2012, the
eligible professional (or group practice)
must meet one of the criteria for
satisfactory reporting described in
section VI.F.1.e. or VI.F.1.f. of this final
rule with comment period (or section
VI.F.1.g. for group practices).
Because this is a voluntary program,
it is difficult to accurately estimate how
many eligible professionals will opt to
participate in the Physician Quality
Reporting System in CY 2012.
Information from the ‘‘Physician Quality
Reporting System 2009 Reporting
Experience Report’’ (hereinafter 2009
Experience Report) which is available
on the Physician Quality Reporting
System section of the CMS Web site at
https://www.cms.hhs.gov/pqrs, indicates
that eligible professionals from nearly
120,000 unique TIN/NPI combinations
satisfactorily submitted Physician
Quality Reporting System quality
measures data for the 2009 Physician
Quality Reporting System. Therefore, for
purposes of conducting a burden
analysis for the 2012 Physician Quality
Reporting System, we will assume that
all eligible professionals who attempted
to participate in the 2009 Physician
Quality Reporting System will also
attempt to participate in the 2012
Physician Quality Reporting System.
We invited but received no public
comment on our estimates regarding the
projected participation in the 2012
Physician Quality Reporting System.
However, for the reasons explained
below, we believe that more eligible
professionals will participate in the
Physician Quality Reporting System in
2012 than in 2009.
According to the 2009 Experience
Report, the number of eligible
professionals eligible to participate and
actually participating in the Physician
Quality Reporting System has increased
each year from 2007 through 2009.
Participation in the Physician Quality
Reporting System has increased from
98,696 out of 621,840 eligible
professionals in 2007 to 164,828 out of
977,415 eligible professionals in 2008 to
221,858 out of 1,042,260 eligible
professionals in 2009.
With respect to participation in 2008,
66,132 more eligible professionals
participated in the 2008 Physician
Quality Reporting System (then called
the Physician Quality Reporting
Initiative or PQRI) than in 2007. The
percentage of eligible professionals
participating in 2008 also increased
from 16 percent in 2007 to 17 percent
in 2008. We believe that this increase
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was due to a number of factors,
including but not exclusive to:
• An increased number of
professionals eligible to participate in
the Physician Quality Reporting System
in 2008: The number of professionals
eligible to participate increased from
621,840 to 977,415 professionals from
2007 to 2008.
• Increased familiarity with the
program: The Physician Quality
Reporting System was first implemented
in 2007. As such, we believe that our
efforts to educate the public on the
Physician Quality Reporting System
through education and outreach efforts
as well as general increased familiarity
of the availability of earning incentives
by satisfactorily reporting Physician
Quality Reporting System measures led
to an increase in program participation.
• The introduction of the registrybased reporting mechanism: In 2007, the
claims-based reporting mechanism was
the only reporting mechanism available
for reporting Physician Quality
Reporting System quality measures. In
2008, eligible professionals were able to
submit data on Physician Quality
Reporting System quality measures via
the registry-based reporting mechanism
as well.
• The introduction of reporting
Physician Quality Reporting System
quality measures via measures groups in
addition to reporting measures
individually: The reporting of Physician
Quality Reporting System quality
measures via measures groups was not
available in 2007. However, in 2008,
eligible professionals had the option of
reporting Physician Quality Reporting
System quality measures via measures
groups via claims and registry.
• An increased number of measures
and measures groups available for
reporting under the Physician Quality
Reporting System.
With respect to participation in 2009,
64,648 more eligible professionals
participated in the 2009 Physician
Quality Reporting System (then called
the Physician Quality Reporting
Initiative or PQRI) than in 2008. The
percentage of eligible professionals
participating in 2008 also increased
from 17 percent in 2008 to 21 percent
in 2009. We believe that this increase
was due to a number of factors,
including but not exclusive to:
• An increased number of
professionals eligible to participate in
the Physician Quality Reporting System
in 2008: The number of professionals
eligible to participate increased from
977,415 to 1,042,260 professionals from
2008 to 2009.
• Increased familiarity with the
program.
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• An increased incentive payment
amount for satisfactory reporting from
1.5 percent in 2008 to 2.0 percent in
2009.
• An increased number of measures
and measures groups available for
reporting under the Physician Quality
Reporting System.
Accordingly, we expect participation
in the 2012 Physician Quality Reporting
System to increase due to a number of
factors, including but not exclusive to:
• Increased familiarity with the
program: 2012 will mark the 6th year
since the Physician Quality Reporting
System was first implemented.
• The availability of the EHR-based
reporting mechanism: As described in
further detail in section VI.F.1.d.3 of
this final rule with comment period, for
2012, we finalized two options under
EHR-based reporting mechanism by
which eligible professionals may utilize
to submit data on Physician Quality
Reporting System quality measures: The
EHR data submission vendor and direct
EHR options.
• An increased number of measures
and measures groups available for
reporting under the Physician Quality
Reporting System: As described in
further detail in section VI.F.1.f of this
final rule with comment period, we
have added additional measures
available for claims, registry, and/or
EHR-based reporting as well as
additional measures groups available for
claims and/or registry reporting.
• The establishment of CY 2013 as
the reporting period for the 2015
payment adjustment. As described in
greater detail in section VI.F.1.j of this
final rule with comment period, we
finalized our proposal to establish CY
2013 as the reporting period for the
2015 payment adjustment. We expect
that more eligible professionals will
attempt to meet the criteria for
satisfactory reporting in 2012 before the
2015 payment adjustment reporting
period commences on January 1, 2013.
• Alignment and incorporation of
certain Physician Quality Reporting
System reporting requirements under
other CMS programs, such as the EHR
Incentive Program and the Medicare
Shared Savings Program. In an effort to
align various CMS quality reporting
programs, we have created reporting
requirements under other CMS
programs that are similar or identical to
those required under the Physician
Quality Reporting System. For example,
as described in greater detail under
section VI.F.1.e.3 of this final rule with
comment period, we established
reporting criteria that satisfy both the
Physician Quality Reporting System
incentive and fulfill the CQM
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requirement for achieving meaningful
use under the EHR Incentive Program
(75 FR 44409 through 44411). In
addition, as described in section VI.F.4
of this final rule with comment period,
the EHR Incentive Program established
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot, whereby
eligible professionals may data on the
same sample of beneficiaries to fulfill
the requirements for satisfactory
reporting under the Physician Quality
Reporting System while also fulfilling
the CQM reporting requirements for
achieving meaningful use under the
EHR Incentive Program.
As finalized in the final rule entitled
‘‘Medicare Program; Medicare Shared
Savings Program: Accountable Care
Organizations,’’ displayed in the
Federal Register on October 20, 2011,
the Medicare Shared Savings Program
also incorporated certain Physician
Quality System reporting requirements
and incentives whereby eligible
professionals within Accountable Care
Organizations (ACOs) may earn under a
group practice reporting option (GPRO)
a Physician Quality Reporting System
incentive under the Medicare Shared
Savings Program.
Furthermore, as stated in section VI.I
of this final rule, under the Physician
Feedback Program, we plan to use the
Physician Quality Reporting System
quality measures in the Physician
Feedback reports we disseminate, and
we are finalizing certain measures from
the Physician Quality Repoting System
and EHR Incentive Program for
purposes of the Physician value
modifier, which will be applied
beginning in CY 2015.
According to the 2009 Experience
Report, we have seen a 1 percent and 4
percent increase in participation in the
Physician Quality Reporting System
from 2007 to 2008 and 2008 to 2009
respectively. Based on our above
assumptions, we believe we will see at
least a 1 percent increase in the number
of eligible professionals participating in
the Physician Quality Reporting System
from 2011 to 2012. Information on
participation rates for the 2010 and 2011
Physician Quality Reporting System is
not yet available. Therefore, for
purposes of determining how many
eligible professionals will participate in
2012, we will assume a 1 percent
increase in participation each program
year from 2009 through 2012. Therefore,
we assume that 224,076 eligible
professionals (a 1 percent increase from
221,858) participated in the 2010
Physician Quality Reporting System. We
then assume that 226,316 eligible
professionals participated in the 2011
Physician Quality Reporting System (a 1
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percent increase from 224,076). Based
on these assumptions, we estimate that
at least 228,579 eligible professionals
will participate in the 2012 Physician
Quality Reporting System (a 1 percent
increase from 226,316).
b. Burden Estimate on Participation in
the 2012 Physician Quality Reporting
System—Individual Eligible
Professionals
As we stated in the proposed rule (76
FR 42921), we believe that the burden
for eligible professionals who are
participating in the Physician Quality
Reporting System for the first time in
2012 will be considerably higher than
the burden for eligible professionals
who have participated in the Physician
Quality Reporting System in prior years.
As described below, some preparatory
steps are needed to begin participating
in the Physician Quality Reporting
System. To the extent that we did not
retire the measures that an eligible
professional has reported in a prior year
and there are no changes to the
measure’s specifications from a prior
year, such preparatory steps will not
need to be repeated in subsequent years.
For individual eligible professionals,
in the proposed rule (76 FR 42922), we
noted that the burden associated with
the requirements of this reporting
initiative will be the time and effort
associated with eligible professional’s
practice identifying applicable
Physician Quality Reporting System
quality measures for which they can
report the necessary information,
collecting the necessary information,
and reporting the information needed to
report the eligible professional’s or
group practice’s measures.
We believe it is difficult to
definitively quantify the burden because
eligible professionals may have different
processes for integrating the data
collection for the Physician Quality
Reporting System measures into their
practice’s work flows. Moreover, we
expect that the time needed for an
eligible professional to review the
quality measures and other information,
select measures applicable to his or her
patients and the services he or she
furnishes to them, and incorporate the
use of quality data codes into the office
work flows will vary along with the
number of measures that are potentially
applicable to a given professional’s
practice.
Since a majority of eligible
professionals participate via claims or
registry-based reporting of individual
measures, they will generally be
required to report on at least three
measures to earn a Physician Quality
Reporting System incentive. Therefore,
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we will assume that each eligible
professional who attempts to submit
Physician Quality Reporting System
quality measures data via claims or
registry reporting is attempting to earn
a Physician Quality Reporting System
incentive payment and reports on an
average of three measures for this
burden analysis.
This burden analysis focuses on those
new to the Physician Quality Reporting
System. We will assign 5 hours as the
amount of time needed for eligible
professionals to review the 2012
Physician Quality Reporting System
Measures List, review the various
reporting options, select the most
appropriate reporting option, identify
the applicable measures or measures
groups for which they can report the
necessary information, review the
measure specifications for the selected
measures or measures groups, and
incorporate reporting of the selected
measures or measures groups into the
office work flows. This estimate is based
on our assumption that an eligible
professional will need up to 2 hours to
review the 2012 Physician Quality
Reporting System Measures List, review
the reporting options, and select a
reporting option and measures on which
to report and 3 hours to review the
measure specifications for up to 3
selected measures or up to 1 selected
measures group and to develop a
mechanism for incorporating reporting
of the selected measures or measures
group into the office work flows.
In the proposed rule (76 FR 42922),
based on information from the
Physician Voluntary Reporting Program
(PVRP), which was a predecessor to the
Physician Quality Reporting System, we
provided an estimated labor cost of $60/
hour. However, in an effort to provide
a more accurate labor cost estimate of
participation for the 2012 Physician
Quality Reporting System, we
conducted an informal poll among a
small sample of participants in the 2011
Physician Quality Reporting System to
determine what employees within an
eligible professional’s practice are
involved with Physician Quality
Reporting System activities. The poll
revealed that a billing clerk typically
handles administrative details with
respect to participating under the
Physician Quality Reporting System
(such as submitting self-nomination
statements), whereas a computer analyst
typically handles the reporting of
Physician Quality Reporting System
quality measures. Based on this
information, we are changing our
estimated labor costs associated with
participating in the Physician Quality
Reporting System.
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For purposes of this burden estimate,
we will assume that a billing clerk will
handle the administrative duties
associated with participating in the
2012 Physician Quality Reporting
System. According to information
published by the Bureau of Labor
Statistics, available at https://
www.bls.gov/oes/current/
oes433021.htm, the mean hourly wage
for a billing clerk is $16.00/hour.
Therefore, for purposes of handling
administrative duties, we estimate an
average labor cost of $16.00/hour.
In addition, for purposes of this
burden estimate, we will assume that a
computer analyst will engage in the
duties associated with the reporting of
2012 Physician Quality Reporting
System quality measures. According to
information published by the Bureau of
Labor Statistics, available at https://
www.bls.gov/oes/current/
oes151121.htm, the mean hourly wage
for a computer analyst is $39.06/hour,
or approximately $40.00/hour.
Therefore, for purposes of reporting on
2012 Physician Quality Reporting
System quality measures, we estimate
an average labor cost of $40.00/hour.
We continue to expect the ongoing
costs associated with Physician Quality
Reporting System participation to
decline based on an eligible
professional’s familiarity with and
understanding of the Physician Quality
Reporting System, experience with
participating in the Physician Quality
Reporting System, and increased efforts
by CMS and stakeholders to disseminate
useful educational resources and best
practices. We also continue to expect
the ongoing costs associated with
Physician Quality Reporting System
participation to decline as we align the
participation requirements in the
Physician Quality Reporting System
with the reporting requirements in the
Medicare and Medicaid Electronic
Health Record (EHR) Incentive Program
such that an eligible professional may
only need to submit data to CMS one
time for multiple purposes.
We believe the burden associated
with actually reporting the Physician
Quality Reporting System quality
measures will vary depending on the
reporting mechanism selected by the
eligible professional.
(1) Burden Estimate on Participation in
the 2012 Physician Quality Reporting
System via the Claims-Based Reporting
Mechanism—Individual Eligible
Professionals
For the claims-based reporting option
being finalized, eligible professionals
must gather the required information,
select the appropriate quality data codes
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(QDCs), and include the appropriate
QDCs on the claims they submit for
payment. The Physician Quality
Reporting System will collect QDCs as
additional (optional) line items on the
existing HIPAA transaction 837–P
and/or CMS Form 1500 (OCN: 0938–
0999). We do not anticipate any new
forms and or any modifications to the
existing transaction or form. We also do
not anticipate changes to the 837–P or
CMS Form 1500 for CY 2012.
Based on our experience with the
PVRP, we continue to estimate that the
time needed to perform all the steps
necessary to report each measure (that
is, reporting the relevant quality data
code(s) for a measure) on claims will
ranges from 15 seconds (0.25 minutes)
to over 12 minutes for complicated
cases and/or measures, with the median
time being 1.75 minutes. At an average
labor cost of $40/hour per practice, the
cost associated with this burden will
range from $0.17 in labor to about $8.00
in labor time for more complicated cases
and/or measures, with the cost for the
median practice being $1.67.
The total estimated annual burden for
this requirement will also vary along
with the volume of claims on which
quality data is reported. In previous
years, when we required reporting on 80
percent of eligible cases for claimsbased reporting, we found that on
average, the median number of reporting
instances for each of the Physician
Quality Reporting System measures was
9. Since we are reducing the required
reporting rate by over one-third to 50
percent in this final rule, then for
purposes of this burden analysis we will
assume that an eligible professional will
need to report each selected measure for
6 reporting instances. The actual
number of cases on which an eligible
professional is required to report quality
measures data will vary, however, with
the eligible professional’s patient
population and the types of measures on
which the eligible professional chooses
to report (each measure’s specifications
includes a required reporting
frequency).
Based on the assumptions discussed
previously, we estimate the total annual
reporting burden per individual eligible
professional associated with claimsbased reporting will range from 4.5
minutes (0.25 minutes per measure × 3
measures × 6 cases per measure) to 180
minutes (12 minutes per measure × 3
measures × 6 cases per measure), with
the burden to the median practice being
31.5 minutes (1.75 minutes per measure
× 3 measures × 6 cases). We estimate the
total annual reporting cost per eligible
professional associated with claimsbased reporting will range from $3.06
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($0.17 per measure × 3 measures × 6
cases per measure) to $144.00 ($8.00 per
measure × 3 measures × 6 cases per
measure), with the cost to the median
practice being $30.06 per eligible
professional ($1.67 per measure × 3
measures × 6 cases per measure).
b. Burden Estimate on Participation in
the 2012 Physician Quality Reporting
System via the Registry-Based Reporting
Mechanism—Individual Eligible
Professionals
For registry-based reporting, there
will be no additional time burden for
eligible professionals to report data to a
registry as eligible professionals opting
for registry-based reporting will more
than likely already be reporting data to
the registry for other purposes and the
registry will merely be re-packaging the
data for use in the Physician Quality
Reporting System. Little, if any,
additional data will need to be reported
to the registry solely for purposes of
participation in the 2012 Physician
Quality Reporting System. However,
eligible professionals will need to
authorize or instruct the registry to
submit quality measures results and
numerator and denominator data on
quality measures to CMS on their
behalf. We estimate that the time and
effort associated with this will be
approximately 5 minutes per eligible
professional.
Registries interested in submitting
quality measures results and numerator
and denominator data on quality
measures to CMS on their participants’
behalf in 2012 will need to complete a
self-nomination process in order to be
considered qualified to submit on behalf
of eligible professionals unless the
registry was qualified to submit on
behalf of eligible professionals for prior
program years and did so successfully.
We estimate that the self-nomination
process for qualifying additional
registries to submit on behalf of eligible
professionals for the 2012 Physician
Quality Reporting System will involve
approximately 1 hour per registry to
draft the letter of intent for selfnomination. We estimate that each selfnominated entity will also spend 2
hours for the interview with CMS
officials and 2 hours calculating
numerators, denominators, and measure
results for each measure the registry
wishes to report using a CMS-provided
measure flow. However, the time it
takes to produce calculated numerators,
denominators, and measure results
using the CMS-provided measure flows
could vary depending on the registry’s
experience and the number and type of
measures for which the registry wishes
to submit on behalf of eligible
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professionals. Additionally, part of the
self-nomination process involves the
completion of an XML submission by
the registry, which we estimate to take
approximately 5 hours, but may vary
depending on the registry’s experience.
We estimate that the registry staff
involved in the registry self-nomination
process will have an average labor cost
of $16/hour. Therefore, assuming the
total burden hours per registry
associated with the registry selfnomination process is 10 hours, we
estimate that the total cost to a registry
associated with the registry selfnomination process will be
approximately $160 ($16 per hour × 10
hours per registry).
The burden associated with the
registry-based reporting requirements of
the Physician Quality Reporting System
will be the time and effort associated
with the registry calculating quality
measures results from the data
submitted to the registry by its
participants and submitting the quality
measures results and numerator and
denominator data on quality measures
to CMS on behalf of their participants.
We expect that the time needed for a
registry to review the quality measures
and other information, calculate the
measures results, and submit the
measures results and numerator and
denominator data on the quality
measures on their participants’ behalf
will vary along with the number of
eligible professionals reporting data to
the registry and the number of
applicable measures. However, we
believe that registries already perform
many of these activities for their
participants. Therefore, there may not
necessarily be a burden on a particular
registry associated with calculating the
measure results and submitting the
measures results and numerator and
denominator data on the quality
measures to CMS on behalf of their
participants. Whether there is any
additional burden to the registry as a
result of the registry’s participation in
the Physician Quality Reporting System
will depend on the number of measures
that the registry intends to report to
CMS and how similar the registry’s
measures are to CMS’ Physician Quality
Reporting System measures.
(2) Burden Estimate on Participation in
the 2012 Physician Quality Reporting
System via the EHR-Based Reporting
Mechanism—Individual Eligible
Professionals
For EHR-based reporting for the CY
2012 Physician Quality Reporting
System, the individual eligible
professional may either submit the
quality measures data directly to CMS
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from their EHR or utilize an EHR data
submission vendor to submit the data to
CMS on the eligible professionals’
behalf. To submit data to CMS directly
from their EHR, the eligible professional
must have access to a CMS-specified
identity management system, such as
IACS, which we believe takes less than
1 hour to obtain. Once an eligible
professional has an account for this
CMS-specified identity management
system, he or she will need to extract
the necessary clinical data from his or
her EHR, and submit the necessary data
to the CMS-designated clinical data
warehouse. With respect to the
requirement for an eligible professional
to submit a test file, we believe that
doing so will take less than 1 hour. With
respect to submitting the actual 2012
data file in 2013, we believe that this
will take an eligible professional no
more than 2 hours, depending on the
number of patients on which the eligible
professional is submitting. We believe
that once the EHR is programmed by the
vendor to allow data submission to
CMS, the burden to the eligible
professional associated with submission
of data on Physician Quality Reporting
System quality measures should be
minimal as all of the information
required to report the measure should
already reside in the eligible
professional’s EHR. We did not
introduce the EHR-based reporting
mechanism into the Physician Quality
Reporting System until 2010. We are
still in the process of analyzing 2010
data. As such, we believe it is difficult
to predict how many eligible
professionals may choose to participate
in the 2012 Physician Quality Reporting
System via the EHR-based reporting
mechanism.
An EHR vendor interested in having
their product(s) used by eligible
professionals to submit the Physician
Quality Reporting System quality
measures data to CMS or interested in
submitting data obtained from an EHR
to CMS on behalf of eligible
professionals is required to complete a
self-nomination process in order for the
vendor and/or its product(s) to be
considered qualified for 2012. It is
difficult to definitively quantify the
burden associated with the EHR selfnomination process as there is variation
regarding the technical capabilities and
experience among vendors. For
purposes of this burden analysis,
however, we estimate that the time
required for an EHR vendor to complete
the self-nomination process will be
similar to the time required for registries
to self-nominate, which is
approximately 10 hours at $16/hour for
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a total of $160/EHR vendor ($16/hour ×
10 hours/EHR vendor).
The burden associated with the EHR
vendor programming its EHR product(s)
to extract the clinical data that the
eligible professional must submit to
CMS for purposes of reporting 2012
Physician Quality Reporting System
quality measures will be dependent on
the EHR vendor’s familiarity with the
Physician Quality Reporting System, the
vendor’s system capabilities, as well as
the vendor’s programming capabilities.
Some vendors already have these
necessary capabilities and for such
vendors, we estimate that the total
burden hours will be 40 hours at a rate
of $40/hour for a total burden estimate
of $1,600 ($40/hour × 40 hours per
vendor). However, given the variability
in the capabilities of the vendors, we
believe those vendors with minimal
experience will have a burden of
approximately 200 hours at $40/hour,
for a total estimate of $8,000 per vendor
($40/hour × 200 hours/EHR vendor).
(3) Burden Estimate on Participation in
the 2012 Physician Quality Reporting
System—Group Practices
With respect to the criteria for
satisfactorily reporting data on the
quality measures for group practices
under the 2012 Physician Quality
Reporting System discussed in section
VI.F.1. of this final rule with comment
period, group practices interested in
participating in the 2012 Physician
Quality Reporting System through the
group practice reporting option (GPRO)
must complete a self-nomination
process similar to the self-nomination
process required of registries and EHR
vendors. Therefore, assuming it takes 2
hours for a group practice to decide
whether to participate as a group or
individually, approximately 2 hours per
group practice to draft the letter of
intent for self-nomination, gather the
requested information, and provide this
requested information, and an
additional 2 hours undergoing the
vetting process with CMS officials, we
estimate a total of 6 hours associated
with the self-nomination process.
Assuming that the group practice staff
involved in the group practice selfnomination process have the same
average practice labor cost as the
average practice labor cost estimates we
used for individual eligible
professionals of $16/hour, we estimate
that the total cost to a group practice
associated with the group practice selfnomination process will be
approximately $96 ($16/hour × 6 hours
per group practice).
The burden associated with the group
practice reporting requirements for the
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2012 Physician Quality Reporting
System is the time and effort associated
with the group practice submitting the
quality measures data. For practices
participating under the GPRO, this will
be the time associated with the
physician group completing the data
collection tool. The information
collection components of this data
collection tool have been reviewed by
OMB and are currently approved under
OMB control number 0938–0941, with
an expiration date of December 31,
2011, for use in the Physician Group
Practice, Medicare Care Management
Performance (MCMP), and EHR
demonstrations. Based on burden
estimates for the PGP demonstration,
which uses the same data submission
methods, we estimate the burden
associated with a physician group
completing the data collection tool will
be approximately 79 hours per
physician group. Based on an average
labor cost of $40 per physician group,
we estimate the cost of data submission
per physician group associated with
participating in the 2012 Physician
Quality Reporting System GPRO will be
$3,160 ($40/hour × 79 hours per group
practice).
(4) Burden Estimate on Participation in
the Maintenance of Certification
Program Incentive
Eligible professionals who wish to
qualify for the additional 0.5 percent
incentive payment authorized under
section 1848(m)(7) of the Act
(‘‘Additional Incentive Payments’’) for
2012 will need to more frequently than
is required to qualify for or maintain
board certification status participate in
a qualified Maintenance of Certification
Program for 2012 and successfully
complete a qualified Maintenance of
Certification Program practice
assessment for 2012. We believe that a
majority of the eligible professionals
who will attempt to qualify for this
additional 0.5 percent incentive
payment will be those who are already
enrolled and participating in a
Maintenance of Certification Board. The
amount of time that it will take for the
eligible professional to participate in the
Maintenance of Certification Program
more frequently than is required to
qualify for or maintain board
certification status will vary based on
what each individual board determines
constitutes ‘‘more frequently.’’ We
expect that the amount of time needed
to complete a qualified Maintenance of
Certification Program practice
assessment will be spread out over time
since a quality improvement component
is often required. Information from an
informal poll of a few ABMS member
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boards indicates that the time an
individual eligible professional spends
to complete the practice assessment
component of the Maintenance of
Certification ranges from 8 to 12 hours.
We requested comments on this
burden analysis for physicians
participating in the Maintenance of
Certification Program incentive,
including the underlying assumptions
used in developing our burden
estimates. Below is a summary of the
comments we received.
Comment: One commenter believed
that a more disciplined approach for
estimating the time and effort it takes to
earn an incentive under the
Maintenance of Certification Program
incentive should be adopted. Another
commenter stated that our estimates
regarding the length of time it takes to
complete the processes required to earn
a Maintenance of Certification Program
incentive does not fully encompass all
activities necessary to participate in a
Maintenance of Certification Program.
Response: We appreciate the
commenters’ feedback. As noted above,
it is difficult to determine the time and
effort it takes to earn an incentive under
the Maintenance of Certification
Program incentive due to varying
specialties, as well as degrees of
experience, and therefore, varying
requirements for participation. We also
note that, for purposes of this burden
estimate, we did not take into account
the time and effort it takes for a
physician to maintain board
certification status under an established
Maintenance of Certification Program.
Rather, we provided an estimate based
on the additional time and effort it will
take for eligible professionals to meet
the additional requirements for earning
the additional 0.5 percent Maintenance
of Certification Program incentive.
3. Electronic Prescribing (eRx) Incentive
Program
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a. Estimate on Participation in the 2012,
2013, and 2014 eRx Incentive Program
The electronic prescribing measure
was first reportable under the Physician
Quality Reporting System before it was
used for the eRx Incentive Program,
which began in 2009. According to the
2009 Experience Report, the number of
eligible professionals participating
reporting the electronic prescribing
measure increased from 4,973 out of
approximately 500,000 eligible
professionals to 92,132 out of 670,000
eligible professionals from 2008 to 2009.
This is an increase of least 12 percent
(from 1 percent in 2008 to 13 percent in
2009). As discussed in section VI.F.2.h.1
in this final rule, we finalized
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limitations whereby a 2013 or 2014
payment adjustment will not apply to
an eligible professional. However, we
still believe that, due to the
implementation of the 2013 and 2014
payment adjustments, as well as the
expansion of the reporting mechanisms
for purposes of reporting the electronic
prescribing measure for the 2013 and
2014 payment adjustments, we expect
that there will be a significant increase
in eligible professionals who participate
in the eRx Incentive Program for CYs
2012 through 2014 from 2009
participation rates. Therefore, for
purposes of conducting a burden
analysis for the 2012 through 2014 eRx
Incentive Program, we will assume that,
based on participation rates in 2009,
there will be an increase of at least 12
percent of eligible professionals
participating in the eRx Incentive
Program from 2012 through 2014.
Therefore, for purposes of this burden
analysis, we estimate that more than
100,800 unique TIN/NPI combinations
will participate in the 2012, 2013, and
2014 eRx Incentive Program for
purposes of the 2013 and 2014 payment
adjustment (see the ‘‘2009 Reporting
Experience,’’ which is available on the
Physician Quality Reporting System
section of the CMS Web site at https://
www.cms.hhs.gov/pqrs). Although this
estimate only accounts for
approximately 15 percent of all
professionals eligible to participate in
the eRx Incentive Program, we believe
that participation may be offset by the
limitations and significant hardship
exemptions we are finalizing for the
2013 and 2014 payment adjustment.
b. Burden Estimate on Participation in
the eRx Incentive Program—Individual
Eligible Professionals
Section VI.F.2. of this final rule with
comment period discusses the
background of the eRx Incentive
Program. For the programs for 2012
through 2014, eligible professionals and
group practices may choose whether to
participate and, to the extent they
meet—(1) certain thresholds with
respect to the volume of covered
professional services furnished; and (2)
the criteria for being a successful
electronic prescriber described in
section VI.F.2. of this final rule with
comment period, they will qualify to
receive an incentive payment for 2012
and 2013 and/or avoid being subject to
the 2013 and 2014 payment adjustment.
In section VI.F.2.g. of this final rule
with comment period, we describe the
requirements for eligible professionals
and group practices to be successful
electronic prescribers in order to earn a
2012 and/or 2013 incentive payment.
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For the 2012 and 2013 incentives, as
discussed in section VI.F.2.g.2. of this
final rule with comment period, each
eligible professional must to report the
electronic prescribing measure’s
numerator indicating that at least one
prescription generated during an
encounter was electronically submitted
at least 25 instances during the
reporting period in association with a
denominator-eligible visit.
In section VI.F.2.h. of this final rule
with comment period, we finalized
additional requirements for eligible
professionals and group practices can
meet for the 2013 payment adjustment,
as well as finalized requirements for
being a successful electronic prescriber
for the 2014 payment adjustment. For
the 2013 and 2014 payment adjustment,
each eligible professional must report
the electronic prescribing measure’s
numerator at least 10 instances during
the reporting period.
We expect the ongoing costs
associated with participation in the eRx
Incentive Program to decline based on
an eligible professional’s understanding
of the eRx Incentive Program,
experience with participating in the eRx
Incentive Program, and increased efforts
by CMS and stakeholders to disseminate
useful educational resources and best
practices.
Similar to the Physician Quality
Reporting System, one factor in the
burden to individual eligible
professionals is the time and effort
associated with individual eligible
professionals reviewing the electronic
prescribing measure to determine
whether it is applicable to them,
reviewing and selecting one of the
available reporting options (for purposes
of the 2012 and 2013 incentives and the
2013 and 2014 payment adjustments,
the electronic prescribing quality
measure is reportable through claimsbased reporting, registry-based
reporting, or through EHRs) and
selecting one, gathering the required
information, and incorporating
reporting of the measure into their office
work flows. Since the eRx Incentive
Program consists of only 1 measure to
report, we estimate 2 hours as the
amount of time that will be needed for
individual eligible professionals to
prepare for participation in the eRx
Incentive Program. At an average cost of
approximately $40/hour per practice,
we estimate the total preparation costs
to individual eligible professionals will
be approximately $80 (2 hours × $40/
hour).
Another factor that we believe
influences the burden to eligible
professionals is how they choose to
report the electronic prescribing
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measure. Our burden estimates for
participating in the eRx Incentive
Program via each of three finalized
reporting mechanisms (that is, claims,
registry, and EHR) are described in this
section.
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(1) Burden Estimate on Participation in
the eRx Incentive Program via the
Claims-Based Reporting Mechanism—
Individual Eligible Professionals
For eligible professionals who choose
to do so via claims, we estimate that the
burden associated with the
requirements of this incentive program
will be the time and effort associated
with gathering the required information
and identifying when it is appropriate to
include the measure’s quality data code
(QDC) on the claims they submit for
payment. For claims-based reporting,
the measure’s QDC will be collected as
additional (optional) line items on the
existing HIPAA transaction 837–P and/
or CMS Form 1500. We do not
anticipate any new forms and or
modifications to the existing transaction
or form. We also do not anticipate
changes to the 837–P or CMS Form 1500
for CY 2012.
Based on the information from the
PVRP for the amount of time it takes a
median practice to report one measure
one time on claims (1.75 minutes) and
our requirement that eligible
professionals report the measure 25
times for purposes of the incentive
payment, we estimate the burden
associated with claims-based data
submission to will be 43.75 minutes
(1.75 minutes per case × 1 measure × 25
cases per measure). This equates to a
cost of approximately $29.17 (1.75
minutes per case × 1 measure × 25 cases
per measure × $40/hour) per individual
eligible professional. For purposes of
the 2013 and 2014 eRx payment
adjustment, an eligible professional is
required to report the measure only 10
times, and therefore, we estimate the
burden associated with claims-based
submission will be 17.5 minutes (1.75
minutes per case × 1 measure × 10 cases
per measure). This equates to a cost of
approximately $9.67 (1.75 minutes per
case × 1 measure × 10 cases per measure
× $40/hour) per individual eligible
professional.
(2) Burden Estimate on Participation in
the eRx Incentive Program via the
Registry-Based Reporting Mechanism—
Individual Eligible Professionals and
Group Practices
Because registry-based reporting of
the electronic prescribing measure to
CMS was added to the eRx Incentive
Program for 2010 and eligible
professionals are not required to
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indicate how they plan to report the
electronic prescribing measure each
year, it is difficult to accurately estimate
how many eligible professionals will
opt to participate in the eRx Incentive
Program through the registry-based
reporting mechanism in CYs 2012
through 2014. We do not anticipate,
however, any additional burden for
eligible professionals to report data to a
registry as eligible professionals opting
for registry-based reporting will more
than likely already be reporting data to
the registry for other purposes. Little, if
any, additional data will need to be
reported to the registry for purposes of
participation in the 2012, 2013, and
2014 eRx Incentive Program since the
only information that the registry will
need to report to us is the number of
times the eligible professional
electronically prescribed. However,
eligible professionals will need to
authorize or instruct the registry to
submit quality measures results and
numerator and denominator data on the
electronic prescribing measure to CMS
on their behalf. We estimate that the
time and effort associated with this will
be approximately 5 minutes for each
eligible professional that wishes to
authorize or instruct the registry to
submit quality measures results and
numerator and denominator data on the
electronic prescribing measure to CMS
on their behalf.
Based on our final decision to
consider only registries qualified to
submit Physician Quality Reporting
System quality measures results and
numerator and denominator data on
quality measures to CMS on their
participants’ behalf for the 2012 and
2013 Physician Quality Reporting
System reporting periods to be qualified
to submit results and numerator and
denominator data on the electronic
prescribing measure for the respective
eRx Incentive Program reporting periods
that occur in 2012 and 2013, there will
be no need for a registry to undergo a
separate self-nomination process for the
eRx Incentive Program and therefore, no
additional burden associated with the
registry self-nomination process.
There will also be a burden to the
registry associated with the registry
calculating results for the electronic
prescribing measure from the data
submitted to the registry by its
participants and submitting the quality
measures results and numerator and
denominator data on the electronic
prescribing quality measure to CMS on
behalf of their participants. We expect
that the time needed for a registry to
review the electronic prescribing
measure’s specifications, calculate the
measure’s results, and submit the
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measure’s results and numerator and
denominator data on their participants’
behalf will vary along with the number
of eligible professionals reporting data
to the registry. However, we believe that
registries already perform many of these
activities for their participants. Since
the eRx Incentive Program consists of
only one measure, we believe that the
burden associated with the registry
reporting the measure’s results and
numerator and denominator to CMS on
behalf of their participants will be
minimal.
(3) Burden Estimate on Participation in
the eRx Incentive Program via the EHRBased Reporting Mechanism—
Individual Eligible Professionals and
Group Practices
For the EHR-based reporting
mechanism, the eligible professional
must either extract the necessary
clinical data from his or her EHR and
submit the necessary data to the CMSdesignated clinical data warehouse or
have an EHR data submission vendor
extract the necessary clinical data from
his or her EHR and submit the necessary
data to CMS on the professional’s
behalf. Because this manner of reporting
quality data to CMS was first added to
the eRx Incentive Program in 2010 and
eligible professionals are not required to
(and were not previously required to)
indicate to us how they intend to report
the electronic prescribing measure, it is
difficult to estimate how many eligible
professionals will opt to participate in
the eRx Incentive Program through the
EHR-based reporting mechanism for
reporting periods that occur in CYs 2012
and 2013. We believe that once an
eligible professional’s EHR is
programmed by the vendor to allow data
submission to CMS, the burden to the
eligible professional associated with
submission of data on the electronic
prescribing measure should be minimal.
The eligible professional who chooses to
submit the electronic prescribing
measure data directly to CMS from his
or her EHR will have to have access to
a CMS-specified identity management
system, such as IACS. We believe it
takes less than 1 hour to obtain access
to the identity management system.
Because only EHR products and data
submission vendors qualified for 2012
and 2013 Physician Quality Reporting
System reporting periods may be used
to submit data on the electronic
prescribing measure for the respective
eRx Incentive Program reporting periods
that occur in CYs 2012 and 2013, there
is no need for EHR vendors and/or their
products to undergo a separate selfnomination process for the eRx
Incentive Program and therefore, no
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emcdonald on DSK4SPTVN1PROD with RULES2
additional burden associated with the
self-nomination process for the eRx
Incentive Program.
There will also be a burden to the
EHR vendor associated with the EHR
vendor programming its EHR product(s)
to extract the clinical data that the
eligible professional and/or vendor will
need to submit to CMS for purposes of
reporting the electronic prescribing
measure. The time needed for an EHR
vendor to review the measure’s
specifications and program its product
to submit data on the measure to the
CMS-designated clinical data warehouse
will be dependent on the EHR vendor’s
familiarity with the electronic
prescribing measure, the vendor’s
system capabilities, as well as the
vendor’s programming capabilities.
Since only EHR products qualified for
2012 and 2013 Physician Quality
Reporting System reporting periods will
qualify for the respective eRx Incentive
Program reporting periods that occur in
CY 2012 or 2013, and the eRx Incentive
Program consists of only one measure,
we believe that any burden associated
with the EHR vendor to program its
product(s) to submit data on the
electronic prescribing measure to the
CMS-designated clinical data warehouse
will be minimal.
(4) Burden Estimate on Participation in
the eRx Incentive Program—Group
Practices
Finally, with respect to the criteria for
group practices to be successful
electronic prescribers for the 2012 and
2013 incentive, as well as with regard to
the 2013 and 2014 payment
adjustments, as discussed in section
VI.F.2. of this final rule with comment
period, respectively, group practices
have the same options as individual
eligible professionals in terms of the
form and manner for reporting the
electronic prescribing measure (that is,
group practices have the option of
reporting the measure through claims, a
qualified registry, or a qualified EHR
product). There are only 2 differences
between the requirements for an
individual eligible professional and a
group practice: (1) The fact that a group
practice must self-nominate; and (2) a
difference in the number of times that
a group practice must report the
electronic prescribing measure.
We do not anticipate any additional
burden associated with the group
practice self-nomination process since
we limit the group practices to those
selected to participate in the Physician
Quality Reporting System GPRO. The
practice only will need to indicate its
desire to participate in the eRx GPRO at
the same time it self-nominates for the
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Physician Quality Reporting System
GPRO and indicate how it intends to
report the electronic prescribing
measure.
In terms of the burden to group
practices comprised of 25 to 99 eligible
professionals associated with
submission of the electronic prescribing
measure, we believe that this will be
similar to the burden to individual
eligible professionals for submitting the
electronic prescribing measure. In fact,
overall, there could be less burden
associated with a practice participating
as a group rather than as individual
eligible professionals because the total
number of reporting instances required
by the group could be less than the total
number of reporting instances that will
be required if each member of the group
separately reported the electronic
prescribing measure. Thus, we believe
that the burden to a group practice
associated with reporting the electronic
prescribing measure could range from
almost no burden (for groups who
choose to do so through a qualified EHR
or registry) to 18.22 hours (1.75 minutes
per measure × 1 measure × 625 cases per
measure) for a group practice that
chooses to report the electronic
prescribing measures through the claims
submission process. Consequently, the
total estimated cost per group practice
to report the electronic prescribing
measure could be as high as $1,043.75
($1.67 per measure × 1 measure × 625
cases per measure).
In terms of the burden to group
practices comprised of 100 or more
eligible professionals associated with
submission of the electronic prescribing
measure, we believe that this will be
similar to the burden to individual
eligible professionals for submitting the
electronic prescribing measure. In fact,
overall, there could be less burden
associated with a practice participating
as a group rather than as individual
eligible professionals because the total
number of reporting instances required
by the group could be less than the total
number of reporting instances that will
be required if each member of the group
separately reported the electronic
prescribing measure. Thus, we believe
that the burden to a group practice
associated with reporting the electronic
prescribing measure could range from
almost no burden (for groups who
choose to do so through a qualified EHR
or registry) to 72.92 hours (1.75 minutes
per measure × 1 measure × 2500 cases
per measure) for a group practice that
chooses to report the electronic
prescribing measures through the claims
submission process. Consequently, the
total estimated cost per group practice
to report the electronic prescribing
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measure could be as high as $4,175
($1.67 per measure × 1 measure × 2500
cases per measure).
As with individual eligible
professionals, we believe that group
practices that choose to participate in
the eRx GPRO through the registrybased reporting mechanism of the
electronic prescribing measure will
more than likely already be reporting
data to the registry. Little, if any,
additional data will need to be reported
to the registry for purposes of
participation in the eRx Incentive
Program for CYs 2012 through 2014
beyond authorizing or instructing the
registry to submit quality measures
results and numerator and denominator
data on the electronic prescribing
measure to CMS on their behalf. We
estimate that the time and effort
associated with this registry option will
be approximately 5 minutes for each
group practice that wishes to authorize
or instruct the registry to submit quality
measures results and numerator and
denominator data on the electronic
prescribing measure to CMS on their
behalf.
For group practices that choose to
participate in the eRx Incentive Program
for CYs 2012 through 2014 via the EHRbased reporting of the electronic
prescribing mechanism, once the EHR is
programmed by the vendor to allow data
submission to CMS, the burden to the
group practice associated with
submission of data on the electronic
prescribing measure should be minimal.
4. Medicare Electronic Health Record
(EHR) Incentive Program for Eligible
Professionals for the 2012 Payment Year
The EHR Incentive Program
(discussed in section VI.H. of this final
rule with comment period) is a
voluntary program whereby eligible
professionals (EPs) may earn an
incentive payment for demonstrating
meaningful use of certified EHR
technology, which includes among
other requirements, the submission of
clinical quality measures (CQMs). The
‘‘Electronic Health Record Incentive
Program’’ final rule (75 FR 44314
through 75 FR 44588) describes the
CQMs and the CQM reporting
mechanisms that will be available to
EPs who choose to participate in the
EHR Incentive Program (75 FR 44380)
and established the criteria for
achieving meaningful use in Stage 1,
which includes CY 2012. In that final
rule, for CY 2012, we estimated that
approximately 385,954 Medicare EPs
will be eligible to receive an incentive
under the EHR Incentive Program (75
FR 44518). Section VI.H.2. of this final
rule with comment period finalizes
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changes to the EHR Incentive Program
for EPs for the 2012 payment year with
respect to the reporting of CQMs for
purposes of achieving meaningful use.
Aside from continuing the attestation
method of reporting CQMs, we will
allow the reporting of CQMs for
purposes of meeting the CQM objective
for demonstrating meaningful use
through participation in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot. Eligible
professionals may participate in the
Pilot by submitting CQMs via (1) a
Physician Quality Reporting System
qualified EHR data submission vendor
or (2) an EHR-based reporting option
using the EP’s certified EHR technology,
which must also be a Physician Quality
Reporting System qualified EHR.
Because the EHR Incentive Program is
a voluntary program, EPs may choose
whether to participate and attest that
they have met the meaningful use
objectives and measures. Registration
for the EHR Incentive Program opened
in January 2011. At this time, we do not
have sufficient data available on
participation in the EHR Incentive
Program by EPs to revise the final rule’s
estimate of how many EPs will opt to
participate in the EHR Incentive
Program for payment year 2012.
We believe the burden associated
with actually reporting CQMs will vary
depending on the reporting mechanism
selected by the EP. Attestation to the
objectives and measures is the only
method available for EPs to demonstrate
that they have met the meaningful use
criteria in 2011. Attestation was first
available on April 18, 2011 and we do
not yet have sufficient data on the 2011
participation in the EHR Incentive
Program. Therefore, it is difficult to
estimate the level of participation in the
Pilot versus the number of EPs that will
prefer to attest to the CQMs. However,
we believe that the number of EPs who
choose to participate via attestation will
largely be those who are not
participating in both the EHR Incentive
Program and Physician Quality
Reporting System. This is because EPs
participating in the Physician Quality
Reporting System will be more likely to
participate in the Pilot.
As we estimated in the EHR Incentive
Program final rule, we estimate that it
will take 8 hours and 52 minutes for an
EP to attest that during the EHR
reporting period, the EP used certified
EHR technology, specify the technology,
and satisfied all Stage 1 meaningful use
core criteria for payment year 2012 (75
FR 44518). We estimate that it will
further take an additional 0.5 hours to
select and attest to the clinical quality
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measures, in the format and manner
specified by CMS (75 FR 44517).
There will be no additional time
burden for eligible professionals to
report CQM data to a qualified EHR data
submission vendor as EPs who choose
this option for the Pilot will more than
likely already be reporting data to the
qualified EHR data submission vendor
for other purposes, such as the
Physician Quality Reporting System,
and the qualified EHR data submission
vendor will merely be re-packaging the
data for use in the EHR Incentive
Program. Furthermore, EPs more than
likely will not need to authorize or
instruct the qualified EHR data
submission vendor to submit CQM data
to CMS on their behalf because this
likely will have already been done as a
requirement for reporting via a qualified
EHR data submission vendor under the
Physician Quality Reporting System.
Qualified EHR data submission
vendors interested in submitting CQM
data to CMS on their participants’ behalf
will not need to complete a selfnomination process in order to be
considered qualified to submit on behalf
of EPs as this process will have already
been performed for the Physician
Quality Reporting System. Therefore,
we believe that there is no additional
burden aside from the burden associated
with being a Physician Qualified
Reporting System qualified EHR data
submission vendor for such vendors to
submit CQMs on behalf of EPs.
For EPs who choose to participate in
the Pilot via direct data submission to
CMS from the EP’s certified EHR
technology, an EP must have access to
a CMS-specified identity management
system, such as IACS, to participate in
the Physician Quality Reporting System
or eRx Incentive Program. EPs that
choose the EHR-based reporting pilot to
report CQMs will do so only if they are
participating in the Physician Quality
Reporting System. As such, we believe
there will be no additional burden on
EPs to have access to a CMS-specified
identity management system if the EP is
already participating in the Physician
Quality Reporting System. With respect
to submitting the actual 2012 data file
in 2013, we believe that this will take
an EP no more than 2 hours, depending
on the number of patients on which the
EP is submitting. We believe that once
the EHR is programmed by the vendor
to allow data submission to CMS and
the EP participates in the Physician
Quality Reporting System, the
additional burden to the EP associated
with electronic submission of the CQMs
should be minimal. Since this is a new
reporting mechanism for the EHR
Incentive Program 2012 payment year, it
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73451
is difficult to predict the level of
participation in EHR-based reporting.
However, we believe that the number of
EPs who choose to participate in the
EHR-based reporting option for the Pilot
will be the same as the number of
eligible professionals who choose the
EHR-based reporting mechanism for the
Physician Quality Reporting System.
This is primarily because in addition to
being certified EHR technology, the
technology used under this reporting
option will need to be qualified
according to the Physician Quality
Reporting System qualification process.
The burden associated with the EHR
vendor programming its EHR product(s)
to extract the clinical data that the EP
or vendor needs to submit to CMS for
purposes of reporting CQMs will be
dependent on the EHR vendor’s
familiarity with the EHR Incentive
Program and Physician Quality
Reporting System, the vendor’s system
capabilities, as well as the vendor’s
programming capabilities. As we
already are requiring qualified EHRs
vendors to perform these functions
under the Physician Quality Reporting
System, the burden for submitting
CQMs under the EHR Incentive Program
will be similar to the EHR vendor
reporting burden under the Physician
Quality Reporting System. For vendors
who already have these necessary
capabilities, we estimate the total
burden hours to be 40 hours at a rate of
$40/hour for a total burden estimate of
$800 ($40/hour × 40 hours per vendor).
However, given the variability in the
capabilities of the vendors, those
vendors with minimal experience will
have a burden of approximately 200
hours at $40/hour, for a total estimate of
$8,000 per vendor ($40/hour × 200
hours per EHR vendor).
To obtain copies of the supporting
statement and any related forms for the
paperwork collections referenced above,
access CMS’ Web site at https://www.
cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp#TopOfPage or email your
request, including your address, phone
number, OMB number, and CMS
document identifier, to Paperwork@cms.
hhs.gov, or call the Reports Clearance
Office at (410) 786–1326.
If you comment on these information
collection and recordkeeping
requirements, please do either of the
following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of this final rule with
comment period; or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
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Budget, Attention: CMS Desk Officer,
[CMS–1524–FC] Fax: (202) 395–5806; or
Email: OIRA_submission@omb.eop.gov.
VIII. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
IX. Regulatory Impact Analysis
A. Statement of Need
This final rule with comment period
is necessary in order to make payment
and policy changes under the Medicare
PFS and to make required statutory
changes under the Affordable Care Act
and MIPPA and other statutory changes.
This final rule with comment period is
also necessary to make changes to the
Part B drug payment policy and other
related Part B related policies.
emcdonald on DSK4SPTVN1PROD with RULES2
B. Overall Impact
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. A
regulatory impact analysis (RIA) must
be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). This
final rule with comment period has
been designated as ‘‘economically’’
significant, under section 3(f)(1) of
Executive Order 12866 and hence also
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a major rule under the Congressional
Review Act. Accordingly, the rule has
been reviewed by the Office of
Management and Budget. We have
prepared an RIA, that to the best of our
ability presents the costs and benefits of
the final rule with comment period. We
solicited comment on the RIA provided.
We received one comment regarding the
RIA.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7.0 million to $34.5 million in any
1 year (for details see the SBA’s Web
site at https://www.sba.gov/content/
table-small-business-size-standards
(refer to the 620000 series)). Individuals
and States are not included in the
definition of a small entity. The RFA
requires that we analyze regulatory
options for small businesses and other
entities. A RFA analysis must include a
justification concerning the reason
action is being taken, the kinds and
number of small entities the rule affects,
and an explanation of any meaningful
options that achieve the objectives with
less significant adverse economic
impact on the small entities.
For purposes of the RFA, physicians,
NPPs, and suppliers including IDTFs
are considered small businesses if they
generate revenues of $10 million or less
based on SBA size standards.
Approximately 95 percent of physicians
are considered to be small entities.
There are over 1 million physicians,
other practitioners, and medical
suppliers that receive Medicare
payment under the PFS.
Because we acknowledge that many of
the affected entities are small entities,
the analysis provided here and
throughout the preamble of this final
rule with comment period constitutes
our Final Regulatory Flexibility Act
(FRFA) analysis for the remaining
provisions. This includes alternatives
considered for the various final policies
in this rule. We solicited public
comment on the IRFA analysis provided
in the proposed rule, but did not receive
any comments that were in scope. We
conclude that this final rule with
comment has a significant impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
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a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area for
Medicare payment regulations and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
of the Act because the Secretary has
determined that this final rule with
comment period would not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2011, that threshold is approximately
$136 million. This final rule with
comment period does not contain
mandates that will impose any costs on
State, local, or tribal governments in
aggregate, or by the private sector, of
$136 million respectively.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This final rule with comment period
will not have a substantial direct effect
on State or local governments, preempt
States, or otherwise have a Federalism
implication.
We have prepared the following
analysis, which together with the
information provided in the rest of this
preamble, meets all assessment
requirements. The analysis explains the
rationale for and purposes of this final
rule with comment period; details the
costs and benefits of the rule; analyzes
alternatives; and presents the measures
we would use to minimize the burden
on small entities. As indicated
elsewhere in this final rule with
comment period, we are implementing
a variety of changes to our regulations,
payments, or payment policies to ensure
that our payment systems reflect
changes in medical practice and the
relative value of services. We provide
information for each of the policy
changes in the relevant sections of this
final rule with comment period. We are
unaware of any relevant Federal rules
that duplicate, overlap, or conflict with
this final rule with comment period.
The relevant sections of this final rule
with comment period contain a
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description of significant alternatives if
applicable.
C. RVU Impacts
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1. Resource-Based Work, PE, and
Malpractice RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act
requires that increases or decreases in
RVUs may not cause the amount of
expenditures for the year to differ by
more than $20 million from what
expenditures would have been in the
absence of these changes. If this
threshold is exceeded, we make
adjustments to preserve budget
neutrality.
Our estimates of changes in Medicare
revenues for PFS services compare
payment rates for CY 2011 with final
payment rates for CY 2012 using CY
2010 Medicare utilization for all years.
To the extent that there are year-to-year
changes in the volume and mix of
services provided by physicians, the
actual impact on total Medicare
revenues will be different than those
shown in Table 84. The payment
impacts reflect averages for each
specialty based on Medicare utilization.
The payment impact for an individual
physician would be different from the
average, based on the mix of services the
physician furnishes. The average change
in total revenues would be less than the
impact displayed here because
physicians furnish services to both
Medicare and non-Medicare patients
and specialties may receive substantial
Medicare revenues for services that are
not paid under the PFS. For instance,
independent laboratories receive
approximately 85 percent of their
Medicare revenues from clinical
laboratory services that are not paid
under the PFS.
Table 84 shows only the payment
impact on PFS services. We note that
these impacts do not include the effect
of the January 2012 conversion factor
changes under current law. The annual
update to the PFS conversion factor is
calculated based on a statutory formula
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that measures actual versus allowed or
‘‘target’’ expenditures, and applies a
sustainable growth rate (SGR)
calculation intended to control growth
in aggregate Medicare expenditures for
physicians’ services. This update
methodology is typically referred to as
the ‘‘SGR’’ methodology, although the
SGR is only one component of the
formula. Medicare physician fee
schedule payments for services are not
withheld if the percentage increase in
actual expenditures exceeds the SGR.
Rather, the PFS update, as specified in
section 1848(d)(4) of the Act, is adjusted
to eventually bring actual expenditures
back in line with targets. If actual
expenditures exceed allowed
expenditures, the update is reduced. If
actual expenditures are less than
allowed expenditures, the update is
increased. We currently estimate that
the statutory formula used to determine
the physician update will result in a CY
2012 conversion factor of 24.6712 which
represents a PFS update of ¥27.4
percent. By law, we are required to
make these reductions in accordance
with section 1848(d) and (f) of the Act,
and these reductions can only be
averted by an Act of the Congress. While
the Congress has provided temporary
relief from these reductions for every
year since 2003, a long-term solution is
critical. We are committed to working
with the Congress to permanently
reform the SGR methodology for
Medicare physician fee schedule
updates so doctors and patients no
longer have to worry about the stability
and adequacy of their payments from
Medicare.
The following is an explanation of the
information represented in Table 84:
• Column A (Specialty): The
Medicare specialty code as reflected in
our physician/supplier enrollment files.
• Column B (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2010 utilization and CY 2011 rates. That
is, allowed charges are the PFS amounts
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for covered services and include
coinsurance and deductibles (which are
the financial responsibility of the
beneficiary). These amounts have been
summed across all services furnished by
physicians, practitioners, and suppliers
within a specialty to arrive at the total
allowed charges for the specialty.
• Column C (Impact of Work and
Malpractice (MP) RVU Changes): This
column shows the estimated CY 2012
impact on total allowed charges of the
changes in the work and malpractice
RVUs, including the impact of changes
due to potentially misvalued codes.
These impacts are primarily due to the
multiple procedure payment reduction
(MPPR) for the professional component
of advanced imaging services.
• Column D (Impact of PE RVU
Changes—Full): This column shows the
estimated CY 2012 impact on total
allowed charges of the changes in the PE
RVUs if there were no remaining
transition to the full use of the PPIS
data.
• Column E (Impact of PE RVU
Changes—Tran): This column shows
the estimated CY 2012 impact on total
allowed charges of the changes in the PE
RVUs under the third year of the 4-year
transition to the full use of the PPIS
data. This column also includes the
impact of the MPPR policy and, and the
impact of changes due to potentially
misvalued codes.
• Column F (Combined Impact—
Full): This column shows the estimated
CY 2012 combined impact on total
allowed charges of all the changes in the
previous columns if there were no
remaining transition to the new PE
RVUs using the PPIS data.
• Column G (Combined Impact—
Tran): This column shows the estimated
CY 2012 combined impact on total
allowed charges of all the changes in the
previous columns under the third year
of the 4-year transition to the new PE
RVUs using the PPIS data. These are
the combined impacts for CY 2012.
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2. CY 2012 PFS Impact Discussion
a. Changes in RVUs
The most widespread specialty
impacts of the RVU changes are
generally related to several factors. First,
as discussed in section II.A.2. of this
final rule with comment period, we are
currently implementing the third year of
the 4-year transition to new PE RVUs
using the PPIS data that were adopted
in the CY 2010 PFS final rule with
comment period. The impacts of the
third year of the transition are generally
consistent with the impacts that would
be expected based on the impacts
displayed in the CY 2011 PFS final rule
with comment period.
The second general factor
contributing to the CY 2012 impacts
shown in Table 84 is a secondary effect
of the CY 2011 rescaling of the RVUs so
that, in the aggregate, they match the
work, PE, and malpractice proportions
in the revised and rebased MEI for CY
2011. That is, the rebased MEI had a
greater proportion attributable to
malpractice and PE and,
correspondingly, a lesser proportion
attributable to work. Specialties that
have a high proportion of total RVUs
attributable to work, such as emergency
medicine, experienced a decrease in
aggregate payments as a result of this
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rescaling, while specialties that have a
high proportion attributable to PE, such
as diagnostic testing facilities,
experienced an increase in aggregate
payments. (For further details on the
MEI rebasing, see the discussion
beginning on (75 FR 73262) in the CY
2011 PFS final rule.)
Table 86 also includes the impacts
resulting from our expansion of the
current MPPR policy to the professional
component of advanced imaging
services. We estimate that this policy
will redistribute approximately $50
million through a small increase in the
conversion factor and a small
adjustment to all PE RVUs. We estimate
that this change would primarily reduce
payments to the specialties of radiology
and interventional radiology. Finally,
Table 84 also reflects the impacts of our
final adjustments to improve the
accuracy of the time associated with the
work RVUs for certain services,
including group therapy services, as
discussed previously in section II.A. of
this final rule with comment period.
Comment: We received comments
asking for clarification of the secondary
effect of the CY 2011 rescaling of the
RVUs for the revised and rebased MEI.
Response: As stated in the CY 2012
PFS proposed rule (ADD CITATION TO
PAGE), a general factor contributing to
the CY 2012 impacts is an effect of the
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CY 2011 rescaling of the RVUs so that,
in the aggregate, they match the work,
PE, and malpractice proportions in the
revised and rebased MEI for CY 2011.
That is, the rebased MEI had a greater
proportion attributable to malpractice
and PE and, correspondingly, a lesser
proportion attributable to work.
Specialties that have a high proportion
of total RVUs attributable to work, such
as emergency medicine, experienced a
decrease in aggregate payments as a
result of this rescaling, while specialties
that have a high proportion attributable
to PE, such as diagnostic testing
facilities, experienced an increase in
aggregate payments. This occurs
because we allocate indirect practice
expenses to the code level partly on the
basis of the direct practice expenses and
the physician work RVUs. The rescaling
of the RVUs for the revised and rebased
MEI slightly increased the proportion of
the indirect allocation based on the
direct practice expenses and decreased
the proportion based on the work RVUs.
b. Combined Impact
Column G of Table 84 displays the
estimated CY 2012 combined impact on
total allowed charges by specialty of all
the final RVU and MPPR changes. These
impacts range from an increase of 4
percent for physical/occupational
therapy and portable x-ray suppliers to
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a decrease of 6 percent for radiation
oncology and radiation therapy centers.
Again, these impacts are estimated prior
to the application of the negative CY
2012 Conversion Factor (CF) update
applicable under the current statute.
Table 85 shows the estimated impact
on total payments for selected high-
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volume procedures of all of the changes
discussed previously. We have included
CY 2012 payment rates with and
without the effect of the CY 2012
negative PFS CF update for comparison
purposes. We selected these procedures
because they are the most commonly
furnished by a broad spectrum of
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physician specialties. There are separate
columns that show the change in the
facility rates and the nonfacility rates.
For an explanation of facility and
nonfacility PE, we refer readers to
Addendum A of this final rule with
comment period.
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D. Effects of Annual Review Process for
Potentially Misvalued Codes Under the
PFS
The process we are adopting in this
final rule with comment period to
consolidate the Five-Year Reviews of
Work and PE RVUs with the annual
review of potentially misvalued codes,
is not anticipated to have a budgetary
impact in CY 2012. As noted previously,
to the extent that we have finalized
revised RVUs for codes identified under
the potentially misvalued codes
initiative for CY 2012, Table 84 includes
the estimated CY 2012 impact on total
allowed charges of the changes in the
RVUs for these codes.
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E. Effect of Final Revisions to
Malpractice RVUs
As discussed in section III.B.3.b. of
this final rule with comment period, we
revised the malpractice risk factors
assigned to a limited number of
cardiothoracic surgery services. The
utilization of many of these services is
zero, while the others have a very low
utilization. Therefore, we estimate no
significant budgetary impact from the
final changes to the MP RVUs due to the
very low utilization of these services.
F. Effect of Final Changes to Geographic
Practice Cost Indices (GPCIs)
As discussed in section II.D. of this
final rule with comment period, we are
required to update the GPCI values at
least every 3 years and phase in the
adjustment over 2 years (if there has not
been an adjustment in the past year).
For CY 2012, we are finalizing revisions
to the PE GPCIs for each Medicare
locality, as well as the cost share
weights for all three GPCI components.
Moreover, the final revised PE GPCI
values are a result of our analysis of the
PE methodology as required by section
1848(e)(1)(H)(iv) of the Act. The final
GPCIs rely upon the 2006–2008
American Community Survey (ACS)
data to determine the relative cost
differences in the office rent component
of the PE GPCIs. In addition, we are
finalizing the use of 2006–2008 Bureau
of Labor and Statistics (BLS)
Occupational Employment Statistics
(OES) data to determine the employee
compensation component. Further, we
are finalizing that the occupations to be
used in the calculation of the employee
compensation component will include
the full range of non-physician
occupations which are employed within
the offices of physicians industry.
Lastly, we are finalizing a purchased
services index that will be used to
geographically adjust for differences in
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the labor-related share of the industries
occupying the ‘‘All Other Services’’ and
‘‘Other Professional Expenses’’ 2006based MEI categories.
We are finalizing a cost share weight
for the PE GPCIs of 47.439 percent. For
the employee compensation portion of
the PE GPCIs, we are using the nonphysician employee compensation
category weight of 19.153 percent. The
fixed capital and utilities MEI categories
were combined to achieve a total office
rent weight of 10.223 percent. In order
to calculate the purchased services
index, we are finalizing our proposal to
merge the corresponding weights of the
‘‘All Other Services’’ and ‘‘Other
Professional Expenses’’ MEI categories
to form a combined purchased services
weight of 8.095. We are finalizing a cost
share weight for the medical equipment,
supplies, and other miscellaneous
expenses component of 9.968 percent.
Furthermore, the physician
compensation cost category and its
weight of 48.266 percent reflects the
work GPCI cost share weight; the
professional liability insurance weight
of 4.295 percent reflects the malpractice
GPCI cost share weight. A more detailed
discussion on the final CY 2012 GPCI
cost share weights can be found in
section II.D. of this final rule with
comment period.
Additionally, section 1848(e)(1)(E) of
the Act (as amended by section 103 of
the Medicare and Medicaid Extenders
Act of 2010) extended the 1.000 work
GPCI floor through December 31, 2011.
Therefore, the CY 2012 GPCIs reflect the
sunset of the 1.000 work GPCI floor.
Section 1848(e)(1)(G) of the Act (as
amended by section 134(b) of the
MIPPA) established a permanent 1.500
work GPCI floor in Alaska beginning
January 1, 2009; therefore, the 1.500
work GPCI floor in Alaska will remain
in place for CY 2012. Moreover, section
1848(e)(1)(I) of the Act (as added by
section 10324(c) of the Affordable Care
Act) established a permanent 1.000 PE
GPCI floor for services furnished in
frontier States effective January 1, 2011.
Addendum D to this final rule with
comment period shows the estimated
effects of the revised GPCIs on locality
Geographic Adjustment Factors (GAFs)
for CY 2012. The GAFs reflect the use
of revised GPCI data and the updated
cost share weights. The GAFs are a
weighted composite of each locality’s
work, PE, and malpractice GPCIs using
the national GPCI cost share weights.
While we do not actually use the GAFs
in computing the PFS payment for a
specific service, they are useful in
comparing the estimated overall costs
and payments for different localities.
The cumulative effects of all of the GPCI
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revisions, including the updated
underlying GPCI data, updated cost
share weights, and provisions of the
Affordable Care Act, are reflected in the
CY 2012 GPCI values that are displayed
in Addendum E in this final rule with
comment period.
Table 86 illustrates the impact of
moving from the current law CY 2011
GAFs to the final CY 2012 GAFs by PFS
locality. The table first shows the
impact under current law and
regulation, and then shows the impact
due to the final rule modifications. As
shown in the table, the primary driver
of the CY 2012 impact is the current law
expiration of the non-budget neutral
increases to the CY 2011 GPCIs for
lower cost areas that was required by
the Affordable Care Act and the MMEA.
The table is sorted by total impact from
largest reductions to largest increases.
When the overall impacts directly
resulting from our final changes to the
PE GPCI are isolated, these final rule
impacts are much smaller (Column F)
than the impacts due to current law and
regulation. Specifically, the PE GPCI
final rule changes cause a change in
GAF values of less than or equal to one
percentage point for approximately nine
out of ten localities. The following
description explains the information
represented in Table 86 in more detail:
• Column (A): Medicare Locality—
The PFS geographic locality.
• Column (B): CY 2011 GAF—The
current CY 2011 Geographic Adjustment
Factor for the locality, which includes
the non-budget neutral increases to the
CY 2011 GPCIs for lower expense areas
authorized by the Affordable Care Act
and the Medicare and Medicaid
Extenders Act. These figures also reflect
the first year of the 2-year transition to
the latest GPCIs that began in 2011.
• Column (C): CY 2012 GAF (Current
Law/Reg)—The CY 2012 Geographic
Adjustment Factor for the locality under
current law and regulations, which
includes the expiration of the nonbudget neutral increases to the CY 2011
GPCIs for lower expense areas
authorized by the Affordable Care Act
and the MMEA. These numbers also
reflect the end of the transition to the
latest GPCIs that began in 2011.
• Column (D): CY 2012 GAF
(Final):—The final CY 2012 Geographic
Adjustment Factor for each locality. The
two largest drivers of the differences
between the GAFs in column (C) and
Column (D) are: The utilization of
residential rent data from the Census
Bureau’s ACS data instead of the
Department of Housing and Urban
Development’s FMR data, and the
benchmarking of the GPCI practice
expense weights to the 2006-based MEI
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cost share weights. The Geographic
Adjustment Factors in this column are
for 2012 and do not reflect any
temporary increases to work and
practice expense required by the
Affordable Care Act.
• Column (E): Percent Change CY
2011 to CY 2012 (current)—Impact of
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the expiration of the non-budget neutral
increases to the CY 2011 GPCIs for
lower expense areas authorized by the
Affordable Care Act and the MMEA and
the end of the transition to the latest
GPCIs that began in 2011.
• Column (F): Percent Change CY
2012 (No NPRM) to CY 2012 (NPRM)—
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Impact of the four regulatory changes
described previously.
• Column (G): Percent Change
Combined Impact CY 2011 to CY 2012—
Combined impact of all changes from
CY 2011 to CY 2012.
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BILLING CODE 4120–01–C
G. Effects of Final Changes to Medicare
Telehealth Services Under the Physician
Fee Schedule
As discussed in section II.E. of this
final rule with comment period, we are
finalizing our policy to add several new
codes to the list of telehealth services
and revise the criteria for adding
services to the list of telehealth services.
While we expect these changes to
increase access to care in rural areas,
based on recent utilization of similar
services already on the telehealth list,
we estimate no significant budgetary
impact from the additions. In addition,
the final revision to the telehealth
criteria will be effective for CY 2013
PFS telehealth services, with no impact
in CY 2012.
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H. Effects of the Impacts of Other
Provisions of the Final Rule With
Comment Period
1. Part B Drug Payment: ASP Issues
Application of our proposals for ‘‘ASP
Reporting Template Update’’ and
‘‘Reporting of ASP Units and Sales
Volume for Certain Products,’’ as
discussed in section VI.A. of this final
rule with comment period involve
revisions to the existing ASP reporting
template which will facilitate the
accuracy and efficiency of data transfer
from manufacturers. Any impacts are
dependent on the status and quality of
quarterly manufacturer data
submissions, so we cannot quantify
associated savings.
Finally, as discussed in section VI.A.
of this final rule with comment period,
we provided for appropriate price
substitutions that account for marketrelated pricing changes and would
allow Medicare to pay based off lower
market prices for those drugs and
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biologicals that consistently exceed the
applicable threshold percentage. Based
on estimates published in various OIG
reports (see section VI.A. for a list of
citations), we believe that this proposal
will generate minor savings for the
Medicare program and its beneficiaries
since any substituted prices would be
for amounts less than the calculated 106
percent of the ASP.
2. Chiropractic Services Demonstration
As discussed in section VI.B. of this
final rule with comment period, we are
continuing the recoupment of the $50
million in expenditures from this
demonstration in order to satisfy the
budget neutrality requirement in section
651(f)(1)(b) of the MMA. We initiated
this recoupment in CY 2010 and this
will be the third year. As discussed in
the CY 2010 PFS final rule with
comment period, we finalized a policy
to recoup $10 million each year through
adjustments to the PFS for all
chiropractors in CYs 2010 through 2014.
To implement this required budget
neutrality adjustment, we are recouping
$10 million in CY 2012 by reducing the
payment amount under the PFS for the
chiropractic CPT codes (that is, CPT
codes 98940, 98941, and 98942) by
approximately 2 percent.
3. Extension of Payment for Technical
Component of Certain Physician
Pathology Services
As discussed in section V.A. of this
final rule with comment period, we are
implementing the provision that
specifies that for services furnished after
December 31, 2011, an independent
laboratory may not bill the Medicare
contractor for the TC of physician
pathology services furnished to a
hospital inpatient or outpatient. The
savings associated with implementing
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this provision are estimated to be
approximately $80 million for CY 2012.
4. Section 4103: Medicare Coverage of
Annual Wellness Visit Providing a
Personalized Prevention Plan:
Incorporation of a Health Risk
Assessment as Part of the Annual
Wellness Visit
As discussed in section VI.E. of this
final rule with comment period, section
1861(s)(2)(FF) of the Act, as described
more fully in section 1861(hhh), of the
Act (as added by section 4103 of the
Affordable Care Act) provides Medicare
coverage for an annual wellness visit.
Regulations for Medicare coverage of the
AWV are established at 42 CFR 410.15.
The annual wellness visit is covered
with no coinsurance or deductible when
furnished by a health professional as
that term is defined in 42 CFR 410.15.
The annual wellness visit entails the
creation of a personalized prevention
plan for an individual and includes
elements, such as updating medical and
family history, identifying providers
that regularly provide medical care to
the individual, measurement of height,
weight, and body mass index,
identification of risk factors, the
provision of personalized health advice,
and development of a screening
schedule (such as a checklist), and
referrals as appropriate for additional
preventive services. Section
1861(hhh)(1)(A) of the Act specifies that
a personalized prevention plan for an
individual includes a HRA that meets
the guidelines established by the
Secretary and takes into account the
results of a HRA. We are proposing to
incorporate the use and results of an
HRA as part of the provision of
personalized prevention plan services
during the AWV. The estimated impact
of incorporating the HRA as part of the
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AWV is unknown for CY 2012. We
specifically requested public comment
on the following:
• The impact of use of the HRA on
health professional practices.
• The burden on health professional
practices of incorporating an HRA into
subsequent AWVs, as well as the first
AWV.
• The impact of the elements
included in the definitions of first and
subsequent AWVs.
• Modification of those AWV
elements for which the Secretary has
authority to determine appropriateness.
A discussion of the comments we
received, our responses, and our final
policy for CY 2012 is available in
section VI.E. of this final rule with
comment period. Our final policy to
increase payment for the AWV to
acknowledge the increased clinical staff
time required to incorporate the HRA
into the AWV is subject to budget
neutrality.
5. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
As discussed in section VI.F.1 of this
final rule with comment period, we are
finalizing several different reporting
options for eligible professionals who
wish to participate in the 2012
Physician Quality Reporting System.
Although there may be some cost
incurred by CMS for maintaining the
Physician Quality Reporting System
measures and their associated code sets,
and for expanding an existing clinical
data warehouse to accommodate the
final registry-based reporting, EHRbased reporting, and group practice
reporting options for the 2012 Physician
Quality Reporting System, we do not
anticipate a significant cost impact on
the Medicare program.
With respect to the potential incentive
payments that may be made to
satisfactory reporters under the 2012
Physician Quality Reporting System, we
estimate this amount for individual
eligible professionals would be
approximately $60 million. This
estimate is derived from looking at our
2009 incentive payment of
approximately $235 million and then
accounting for the fact that the 2009
incentive payment was 2.0 percent of an
eligible professional’s total estimated
Medicare Part B PFS allowed charges for
all such covered professional services
furnished by the eligible professional
during the 2009 reporting period. For
2012, the incentive payment is 0.5
percent of an eligible professional’s total
estimated Medicare Part B PFS allowed
charges for all covered professional
services furnished by an eligible
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professional during the 2012 reporting
period. Although we expect that the
lower incentive payment percentage for
2012 would reduce the total outlay by
approximately one-fourth, we also
expect more eligible professionals to
participate in the 2012 Physician
Quality Reporting System because we
are finalizing multiple methods of data
submission, additional alternative
reporting methods, methods to align the
Physician Quality Reporting System
with the EHR Incentive Program and the
Medicare Shared Savings Program, and
CY 2013 as the reporting period for the
2015 payment adjustment. We also
believe that some eligible professionals
will qualify for the additional 0.5
percent incentive authorized under
section 1848(m)(7) of the Act
(‘‘Additional Incentive Payment’’).
With respect to estimated costs
associated with reporting by individual
eligible professionals, one factor that
influences the cost to individual eligible
professionals is the time and effort
associated with identifying applicable
Physician Quality Reporting System
quality measures and reviewing and
selecting a reporting option. This
burden will vary with each individual
eligible professional by the number of
applicable measures, the eligible
professional’s understanding of the
Physician Quality Reporting System,
experience with Physician Quality
Reporting System participation, and the
method(s) selected by the eligible
professional for reporting of the
measures, and incorporating the
reporting of the measures into the office
work flows.
In the proposed rule (72 FR 42938),
we estimated an average practice labor
cost of $40/hour for our impact analysis.
However, in an effort to provide a more
accurate labor cost estimate of
participation for the 2012 Physician
Quality Reporting System, we
conducted an informal poll among a
small sample of participants in the 2011
Physician Quality Reporting System to
determine what employees within an
eligible professional’s practice are
involved with Physician Quality
Reporting System activities. The poll
revealed that a billing clerk typically
handles administrative details with
respect to participating under the
Physician Quality Reporting System
(such as submitting self-nomination
statements), whereas a computer analyst
typically handles the reporting of
Physician Quality Reporting System
quality measures. Based on this
information, we are changing our
estimated labor costs associated with
participating in the Physician Quality
Reporting System.
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For purposes of this impact analysis,
we will assume that a billing clerk will
handle the administrative duties
associated with participating in the
2012 Physician Quality Reporting
System. According to information
published by the Bureau of Labor
Statistics, available at https://www.bls.
gov/oes/current/oes433021.htm, the
mean hourly wage for a billing clerk is
$16.00/hour. Therefore, for purposes of
handling administrative duties, we
estimate an average labor cost of $16.00/
hour.
In addition, for purposes of this
impact analysis, we will assume that a
computer analyst will engage in the
duties associated with the reporting of
2012 Physician Quality Reporting
System quality measures. According to
information published by the Bureau of
Labor Statistics, available at https://
www.bls.gov/oes/current/
oes151121.htm, the mean hourly wage
for a computer analyst is $39.06/hour,
or approximately $40.00/hour.
Therefore, for purposes of reporting on
2012 Physician Quality Reporting
System quality measures, we estimate
an average labor cost of $40.00/hour.
Participation in the CY 2012
Physician Quality Reporting System by
individual eligible professionals and
group practices is voluntary and
individual eligible professionals and
group practices may have different
processes for integrating the collection
of the Physician Quality Reporting
System measures into their practice’s
work flows. Given this variability and
the multiple reporting options that we
provide, it is difficult to definitively
estimate the impact of the Physician
Quality Reporting System on providers.
Furthermore, we believe that costs for
eligible professionals who are
participating in the Physician Quality
Reporting System for the first time in
2012 would be considerably higher than
the cost for eligible professionals who
participated in the Physician Quality
Reporting System in prior years. Some
preparatory steps are needed to begin
participating in the Physician Quality
Reporting System. To the extent that we
are retaining measures that an eligible
professional has reported in a prior year
and there are no changes to the
measure’s specifications from a prior
year, such preparatory steps do not need
to be repeated in subsequent years. In
addition, for many eligible
professionals, the cost of participating
in the Physician Quality Reporting
System is offset by the incentive
payment, if earned.
Assuming that it takes an individual
eligible professional approximately 5
hours to review the Physician Quality
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Reporting System quality measures,
review the various reporting options,
select the most appropriate reporting
option, identify the applicable measures
for which they can report the necessary
information, and incorporate reporting
of the selected measures into their office
work flows, we estimate that the cost to
eligible professionals associated with
preparing to report Physician Quality
Reporting System quality measures will
be approximately $200 per individual
eligible professional ($40 per hour × 5
hours).
Another factor that influences the cost
to individual eligible professionals is
how they choose to report the Physician
Quality Reporting System measures
(that is, whether they select the claimsbased, registry-based or EHR-based
reporting mechanism we are finalizing).
For the claims-based reporting
mechanism, estimates from the PVRP
indicate the time needed to perform all
the steps necessary to report quality
data codes (QDCs) for 1 measure on a
claim ranges from 15 seconds (0.25
minutes) to 12 minutes for complicated
cases or measures. In previous years,
when we required reporting on 80
percent of eligible cases for claimsbased reporting, we found that on
average, the median number of reporting
instances for each of the Physician
Quality Reporting System measures was
9. Since we reduced the required
reporting rate by over one-third to 50
percent, then for purposes of this impact
analysis we will assume that an eligible
professional will need to report each
selected measure for 6 reporting
instances, or 6 cases. Assuming that an
eligible professional, on average, will
report 3 measures since a majority of
eligible professionals participate in the
Physician Quality Reporting System by
reporting individual measures via
claims or registry and that an eligible
professional reports on an average of 6
reporting instances per measure, we
estimate that the cost to an individual
eligible professional associated with the
claims-based reporting option of
Physician Quality Reporting System
measures will range from approximately
$2.64 (0.25 minutes per reporting
instance × 6 reporting instances per
measure × 3 measures × $40/hour) to
$144.00 (12 minutes per reporting
instance × 6 reporting instances per
measure × 3 measures × $40/hour). If an
eligible professional satisfactorily
reports, these costs will more than likely
be negated by the incentive, if earned.
For the 2009 Physician Quality
Reporting System, which had a 2.0
percent incentive, the mean incentive
amount was close to $2,000 for an
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individual eligible professional. For the
registry-based reporting option,
individual eligible professionals will
generally incur a cost to submit data to
registries. We estimate that fees for
using a qualified registry will range
from no charge, or a nominal charge, for
an individual eligible professional to
use a registry to several thousand
dollars, with a majority of registries
charging fees ranging from $500 to
$1,000. However, our impact analysis is
limited to the incremental costs
associated with Physician Quality
Reporting System reporting, which we
believe are minimal. We believe that
many eligible professionals who select
the registry-based reporting option will
already be utilizing the registry for other
purposes and will not need to report
additional data to the registry
specifically for Physician Quality
Reporting System. The registries also
often provide the eligible professional
services above and beyond what is
required for the Physician Quality
Reporting System.
For the EHR-based reporting option,
an individual eligible professional
generally will incur a cost associated
with purchasing an EHR product.
Although we do not believe that the
majority of eligible professionals will
purchase an EHR solely for the purpose
of participating in Physician Quality
Reporting System, cost estimates for
EHR adoption by eligible professionals
from the EHR Incentive Program final
rule (75 FR 44549) show that an
individual eligible professional who
chooses to do so will have to spend
anywhere from $25,000 to $54,000 to
purchase and implement an EHR and up
to $18,000 annually for ongoing
maintenance.
Although we believe that the majority
of eligible professionals attempting to
qualify for the additional 0.5 percent
incentive payment authorized by
section 1848(m)(7) of the Act will be
those who are already required by their
Boards to participate in a Maintenance
of Certification Program, individual
eligible professionals who wish to
qualify for the additional 0.5 percent
incentive payment and are not currently
participating in a Maintenance of
Certification Program will also have to
incur a cost for participating in a
Maintenance of Certification Program.
The manner in which fees are charged
for participating in a Maintenance of
Certification Program vary by specialty.
Some Boards charge a single fee for
participation in the full cycle of
Maintenance of Certification Program.
Such fees appear to range anywhere
from over $1,100 to nearly $1,800 per
cycle. Some Boards have annual fees
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that are paid by their diplomates. On
average, ABMS diplomates pay
approximately $200.00 per year for
participating in Maintenance of
Certification Program. Some Boards
have an additional fee for the
Maintenance of Certification Program
Part III secure examination, but most
Boards do not have additional charges
for participation in practice/quality
improvement activities.
With respect to the final group
practice requirements for satisfactorily
submitting quality measures data for the
CY 2012 Physician Quality Reporting
System discussed in section VI.F.1 of
this final rule with comment period,
group practices interested in
participating in the CY 2012 Physician
Quality Reporting System through the
group practice reporting option (GPRO)
may also incur a cost. However, for
groups that satisfactorily report for the
2012 Physician Quality Reporting
System, we believe these costs will be
completely offset if the group practice
earns the incentive payment since the
group practice will be eligible for an
incentive payment equal to 0.5 percent
of the entire group’s total estimated
Medicare Part B PFS allowed charges for
covered professional services furnished
by the group practice during the
reporting period.
One factor in the cost to group
practices will be the costs associated
with the self-nomination process.
Similar to our estimates for staff
involved with the claims-based
reporting option for individual eligible
professionals, we also estimate that the
group practice staff involved in the
group practice self-nomination process
will have an average administrative
labor cost of $16/hour. Therefore,
assuming 2 hours for a group practice to
decide whether to participate as a group
or have members of the practice
participate individually and 4 hours for
the self-nomination process, we
estimate the total cost to a group
practice associated with the group
practice self-nomination process will be
approximately $96 ($16/hour × 6 hours
per group practice).
For groups participating under the
GPRO process that are comprised of 25
or more eligible professionals, another
factor in the cost to the group will be the
time and effort associated with the
group practice completing and
submitting the GPRO web interface.
Based on the Physician Group Practice
(PGP) demonstration’s estimate that it
takes approximately 79 hours for a
group practice to complete the data
collection, which uses the same data
submission methods as those we have
finalized, we estimate the cost
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costs for registries associated with a
registry calculating quality measures
results from the data submitted to the
registry by its participants and
submitting the quality measures results
and numerator and denominator data on
quality measures to CMS on behalf of
their participants under the final
program for 2012. We believe that the
majority of registries already perform
these functions for their participants.
An EHR vendor interested in having
its product(s) be used by individual
eligible professionals to submit the final
Physician Quality Reporting System
measures to CMS for 2012 will have to
complete the vetting process during
2012 and program its EHR product(s) to
extract the clinical data that the eligible
professional will need to submit to CMS
for purposes of reporting the final 2012
quality measures in 2013 as well.
Previously qualified vendors will need
to only update their electronic measure
specifications and data transmission
schema during 2012 to incorporate any
new EHR measures we are finalizing to
maintain their qualification for the 2012
Physician Quality Reporting System.
Therefore, for EHR vendors that were
not previously qualified, we estimate
the cost associated with completing the
self-nomination process, including the
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vetting process with CMS officials, will
be $400 ($40/hour × 10 hours per EHR
vendor). Our estimate of a $40 per hour
average labor cost for EHR vendors is
based on the assumption that vendor
staff include computer analysts. We
believe that the cost associated with the
time and effort needed for an EHR
vendor to review the quality measures
and other information and program the
EHR product to enable individual
eligible professionals to submit
Physician Quality Reporting System
quality measures data to the CMSdesignated clinical warehouse will be
dependent on the EHR vendor’s
familiarity with the Physician Quality
Reporting System, the vendor’s system’s
capabilities, as well as the vendor’s
programming capabilities. Some
vendors already have the necessary
capabilities and for such vendors, we
estimate the total cost will be
approximately $1,600 ($40/hour × 40
hours per vendor). However, given the
variability in the capabilities of the
vendors, we believe an estimate for
those vendors with minimal experience
will be approximately $8,000 per
vendor ($40/hour × 200 hours per EHR
vendor).
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associated with a physician group
completing the GPRO web interface will
be approximately $4,740 ($40/hour × 79
hours per group practice).
In addition to costs incurred by
individual eligible professionals and
group practices, registries and EHR
vendors may also incur some costs
related to the final requirements for the
2012 Physician Quality Reporting
System. Registries interested in
becoming ‘‘qualified’’ to submit on
behalf of individual eligible
professionals will also have to incur a
cost associated with the vetting process,
calculating quality measures results
from the data submitted to the registry
by its participants, and submitting the
quality measures results, as well as
numerator and denominator data on
quality measures, to CMS on behalf of
their participants. We estimate the
registry self-nomination process will
cost approximately $400 per registry
($40 per hour × 10 hours per registry).
This cost estimate includes the cost of
submitting the self-nomination letter to
CMS and completing the final CMS
vetting process. Our estimate of $40 per
hour average labor cost for registries is
based on the assumption that registry
staff include computer analysts. We do
not believe that there are any additional
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6. Incentives for Electronic Prescribing
(eRx)—The Electronic Prescribing
Incentive Program
Section VI.F.2. of this final rule with
comment period describes the
Electronic Prescribing (eRx) Incentive
Programs finalized for CYs 2012 through
2014. To be considered a successful
electronic prescriber in CYs 2012
through 2014, an individual eligible
professional must meet the final
requirements described in section
VI.F.2. of this final rule with comment
period.
From 2009, over 90,000 eligible
professionals participated in the eRx
Incentive Program. We anticipate that
despite a decrease in the applicable
quality incentive percent from 2 percent
in 2009 to 1 percent (of total estimated
Medicare Part B allowed charges for
covered professional services) in 2012
and 0.5 percent in 2013, more eligible
professionals (and group practices) will
choose to participate in the eRx
Incentive Program due to the 2013 and
2014 payment adjustments of 1.5
percent and 2.0 percent, respectively
(reduction of the physician fee schedule
amount that would otherwise apply to
such services in 2013 and 2014), for
eligible professionals who are not
successful electronic prescribers. In
order to become a successful electronic
prescriber for purposes of the 2013 and
2014 payment adjustments under the 6month payment adjustment reporting
periods, we are finalizing more
opportunities to report on the electronic
prescribing measure by concentrating
only on the numerator of the measure.
Similar to the percentage increase from
the 2008 to 2009 eRx Incentive Program,
as well as taking into account the
limitations and significant hardship
exemptions we are finalizing for the
2013 and 2014 payment adjustments,
we anticipate a 12 percent increase in
the number of eligible professionals
participating in the eRx Incentive
Program from 2012 through 2014.
Therefore, for purposes of this burden
analysis, we estimate that more than
100,800 unique TIN/NPI combinations
will participate in the 2012, 2013, and
2014 eRx Incentive Program
Although, as we stated previously, we
expect participation in the eRx
Incentive Program to increase due to the
implementation of the 2013 and 2014
payment adjustments, we do not believe
this expected increase in participation
will affect the number of eligible
professionals participating in the eRx
Incentive Program for purposes of
earning an incentive. For the 2009 eRx
Incentive Program, based on an
incentive of 2.0 percent of eligible
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professionals’ total estimated Medicare
Part B allowed charges for covered
professional services, approximately
$148 million in total incentives were
paid to eligible professionals with a
mean incentive amount of
approximately $3,000. Whereas the
applicable quality incentive percent for
2009 was 2.0 percent, the applicable
percent for the 2012 and 2013
incentives are 1.0 percent and 0.5
percent, respectively. Since the
applicable quality percent for the 2012
incentive is half that of the 2009
incentive, we estimate that $74 million
in total incentives will be paid to
eligible professionals for the 2012
incentive. Since the applicable quality
percent for the 2013 incentive is onefourth that of the 2009 incentive, we
estimate that $37 million in total
incentives will be paid to eligible
professionals for the 2013 incentive.
Therefore, for the 2012 and 2013
incentives, we estimate that a total of
$111 million will be distributed to
eligible professionals who become
successful electronic prescribers.
With respect to the costs of
participating in the eRx Incentive
Program for eligible professionals and
group practices, we estimate that the
cost impact of the eRx Incentive
Programs for CYs 2012 through 2014 on
the Medicare program will be the cost
incurred for maintaining the electronic
prescribing measure and its associated
code set, and for maintaining the
existing clinical data warehouse to
accommodate the registry-based
reporting and EHR-based reporting
options for the electronic prescribing
measure. However, we do not believe
that the program for CYs 2012 through
2014 have a significant administrative
cost impact on the Medicare program
since much of this infrastructure has
already been established for the eRx
Incentive Program.
Individual eligible professionals and
group practices may have different
processes for integrating data collection
on the electronic prescribing measure
into their practices’ work workflows.
Given this variability and the multiple
reporting options that we are finalizing,
it is difficult to accurately estimate the
impact of the eRx Incentive Program for
CYs 2012 through 2014 on providers.
Furthermore, we believe that costs for
eligible professionals who will
participate in the eRx Incentive Program
for the first time will be considerably
higher than the cost for eligible
professionals who participated in the
eRx Incentive Program in prior years, as
there are preparatory steps that an
eligible professional will need to take to
begin participating in the program. In
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addition, for many eligible professionals
(especially those who participated in
the eRx Incentive Program in prior
years), we believe the cost of
participating in the eRx Incentive
Program in 2012 or 2013 will be offset
by the incentive payment, if earned. As
a result of the payment adjustment that
begins in 2012 and continues until
2014, the cost of not participating in the
eRx Incentive Program for CYs 2012
through 2014 could be higher than the
cost of participating in the form of
reduced Medicare payments as a result
of the payment adjustment (if
applicable).
Any eligible professional who wishes
to participate in the eRx Incentive
Program must have a qualified
electronic prescribing system in order to
participate. Therefore, a one-time
potential cost to some individual
eligible professionals will be the cost of
purchasing and using an electronic
prescribing system, which varies by the
commercial software package selected,
the level at which the professional
currently employs information
technology in his or her practice and the
training needed. One study indicated
that a midrange complete electronic
medical record with electronic
prescribing functionality costs $2,500
per license with an annual fee of $90
per license for quarterly updates of the
drug database after setup costs while
standalone prescribing, messaging, and
problem list system may cost $1,200 per
physician per year after setup costs.
Hardware costs and setup fees
substantially add to the final cost of any
software package. (Corley, S.T. (2003).
‘‘Electronic prescribing: a review of
costs and benefits.’’ Topics in Health
Information Management 24(1):29–38.).
These are the estimates that we are
using for our impact analysis.
Similar to the Physician Quality
Reporting System, one factor in the cost
to individual eligible professionals is
the time and effort associated with
individual eligible professionals
reviewing the electronic prescribing
measure to determine whether it is
applicable to them, reviewing the
available reporting options and selecting
one, gathering the required information,
and incorporating reporting of the
measure into their office work flows.
Since the eRx Incentive Program
consists of only 1 quality measure, we
estimate 2 hours as the amount of time
needed for individual eligible
professionals to prepare for
participation in the eRx Incentive
Program. Information obtained from the
PVRP, which was a predecessor to the
Physician Quality Reporting System and
was the first step for physician quality
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reporting through certain quality
metrics, indicated an average labor cost
per practice of approximately $40/hour.
To account for salary increases over
time, we use an average practice labor
cost of $40/hour for our estimates, based
on an assumption of an average annual
increase of approximately 3 percent. At
an average cost of approximately $40/
hour, we estimate the total preparation
costs to individual eligible professionals
to be approximately $80 ($40/hour × 2
hours).
Another factor that influences the cost
to individual eligible professionals is
how they choose to report the electronic
prescribing measure (that is, whether
they select the claims-based, registrybased or EHR-based reporting
mechanism). For claims-based
reporting, there will be a cost associated
with reporting the appropriate QDC on
the claims an individual eligible
professional submits for payment. Based
on the information from the PVRP
described previously for the amount of
time it takes a median practice to report
one measure one time (1.75 minutes)
and the requirement to report 25
electronic prescribing events during
2012, we estimate the annual estimated
cost per individual eligible professional
to report the electronic prescribing
measure via claims-submission will be
$43.75 (1.75 minutes per case × 1
measure × 25 cases per measure × $40/
hour). We believe that for most
successful electronic prescribers who
earn an incentive, these costs will be
negated by the incentive payment
received given that the average
incentive for eligible professionals who
qualified for a 2009 eRx incentive was
around $3,000.
For eligible professionals who select
the registry-based reporting mechanism,
we do not anticipate any additional cost
for individual eligible professionals to
report data to a registry, as individual
eligible professionals opting for registrybased reporting are more than likely
already reporting data to the registry.
Little if any, additional data will need
to be reported to the registry for
purposes of participation in the eRx
Incentive Program for CYs 2012 through
2014. Individual eligible professionals
using registries for Physician Quality
Reporting System will likely experience
minimal, if any, increased costs charged
by the registry to report this 1 additional
measure.
For EHR-based reporting, the eligible
professional must extract the necessary
clinical data from his or her EHR, and
submit the necessary data to the CMSdesignated clinical data warehouse.
Once the EHR is programmed by the
vendor to allow data submission to
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CMS, the cost to the individual eligible
professional associated with the time
and effort to submit data on the
electronic prescribing measure should
be minimal.
With respect to the requirements for
group practices for the 2012 and 2013
incentives and 2013 and 2014 payment
adjustments discussed in section VI.F.2.
of this final rule with comment period,
group practices have the same options
as individual eligible professionals in
terms of the form and manner for
reporting the electronic prescribing
measure (that is, group practices have
the option of reporting the measure
through claims, a qualified registry, or a
qualified EHR product). There are only
2 differences between the requirements
for an individual eligible professional
and a group practice: (1) the fact that a
group practice must self-nominate; and
(2) the number of times a group practice
must report the electronic prescribing
measure. Overall, there could be less
cost associated with a practice
participating in the eRx Incentive
Program as a group rather than the
individual members of the group
separately participating. We do not
believe that there are any additional
costs associated with the group practice
self-nomination process since we are
limiting the group practices to those
selected to participate in the 2012, 2013,
and/or 2014 respective Physician
Quality Reporting System GPRO. The
practices only must indicate their desire
to participate in the eRx GPRO at the
time they self-nominate for the
Physician Quality Reporting System
GPRO.
The costs for a group practice
reporting to an EHR or registry should
be similar to the costs associated with
registry and EHR reporting for an
individual eligible professional, as the
process is the same with the exception
that more electronic prescribing events
must be reported by the group. For
similar reasons, the costs for a group
practice reporting via claims should also
be similar to the costs associated with
claims-based reporting for an individual
eligible professional. Therefore, we
estimate that the costs for group
practices who are selected to participate
in the eRx Incentive Program for CYs
2012 through 2014 will range from
$799.17 (1.75 minutes per case × 1
measure × 625 cases per measure × $40/
hour) for groups comprised of 25–99
eligible professionals participating to
$2,916.67 (1.75 minutes per case × 2500
cases per measure × $40/hour) for the
groups comprised of 100 or more
eligible professionals.
We believe that the costs to individual
eligible professionals and group
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practices associated with meeting the
requirements for the 2013 and 2014
payment adjustments will be similar to
the costs of an eligible professional or
group practice reporting the electronic
prescribing measure for purposes of the
2012 and 2013 incentives. Specifically,
we believe that the cost of reporting the
electronic prescribing measure in one
instance for purposes of the payment
adjustment is identical to the cost of
reporting the electronic prescribing
measure for one instance on claims for
purposes of the incentive payment. The
only difference will be in the total costs
for an individual eligible professional.
Group practices are required to report
the electronic prescribing measure for
the same number of electronic
prescribing events for both the 2012 and
2013 incentives and the 2013 and 2014
payment adjustments. Individual
eligible professionals, however, are
required to report the electronic
prescribing measure for only 10
electronic prescribing events for
purposes of the 2013 and 2014 payment
adjustments, as opposed to 25 electronic
prescribing events for purposes of the
2012 and 2013 incentives.
Based on our decision to consider
only registries qualified to submit
quality measures results and numerator
and denominator data on quality
measures to CMS on their participant’s
behalf for the 2012, 2013, and 2014
Physician Quality Reporting System to
be qualified to submit results and
numerator and denominator data on the
electronic prescribing measure for eRx
Incentive Program for CYs 2012, 2013,
and 2014, respectively, we do not
estimate any cost to the registry
associated with becoming a registry
qualified to submit the electronic
prescribing measure for CYs 2012
through 2014.
The cost for the registry will be the
time and effort associated with the
registry calculating results for the
electronic prescribing measure from the
data submitted to the registry by its
participants and submitting the quality
measures results and numerator and
denominator data on the eRx quality
measure to CMS on behalf of their
participants. We believe such costs will
be minimal as registries will already be
required to perform these activities for
Physician Quality Reporting System.
Likewise, based on our decision to
consider only EHR products qualified
for the Physician Quality Reporting
System for CYs 2012, 2013, and 2014 to
be qualified to submit results and
numerator and denominator data on the
electronic prescribing measure for the
eRx Incentive Program for CYs 2012,
2013, and 2014, there is no need for
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EHR vendors to undergo a separate selfnomination process for the eRx
Incentive Program. Therefore, there will
be no additional cost associated with
the self-nomination process.
The cost to the EHR vendor associated
with the proposed EHR-based reporting
requirements of this reporting initiative
is the time and effort associated with the
EHR vendor programming its EHR
product(s) to extract the clinical data
that the individual eligible professional
needs to submit to CMS for reporting
the electronic prescribing measure.
Since we determined that only EHR
products qualified for the Physician
Quality Reporting System are qualified
for the eRx Incentive Program, and the
eRx Incentive Program consists of only
one measure, we believe that any
burden associated with the EHR vendor
to program its product(s) to enable
individual eligible professionals to
submit data on the electronic
prescribing measure to the CMSdesignated clinical data warehouse will
be minimal.
emcdonald on DSK4SPTVN1PROD with RULES2
7. Physician Compare Web Site
Section VI.G.2. of this final rule with
comment period discusses the
background of the Physician Compare
Web site. As described in section VI.G.2.
of this final rule with comment period,
we are developing aspects of the
Physician Compare Web Site in stages.
We are finalizing our proposal to
include performance information with
respect to the 2012 Physician Quality
Reporting System GPRO measures. As
reporting of physician performance rates
on the Physician Compare Web Site will
be performed directly by us using the
data that we collect under the 2012
Physician Quality Reporting System
GPRO, we do not anticipate any notable
impact on eligible professionals with
respect to the posting of information on
the Physician Compare Web Site.
8. Medicare EHR Incentive Program
Section VI.H.2. of this final rule with
period finalizes changes to the EHR
Incentive Program for EPs for the 2012
payment year with respect to the
reporting of CQMs for achieving
meaningful use. Aside from continuing
the attestation method of reporting
CQMs, we are allowing the reporting of
CQMs for purposes of demonstrating
meaningful use through participation in
the Physician Quality Reporting SystemMedicare EHR Incentive Pilot via— (1)
a Physician Quality Reporting System
qualified EHR data submission vendor
or (2) using an EP’s certified EHR
technology, which also must be a
Physician Quality Reporting System
qualified EHR.
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We believe the impact associated with
actually reporting CQMs will vary
depending on how the EP chooses to do
so. We believe that the number of EPs
who choose to participate via attestation
will largely be those who are not
participating in both the EHR Incentive
Program and Physician Quality
Reporting System as this is the method
of reporting most favorable to EPs not
participating in the Physician Quality
Reporting System. EPs participating in
the Physician Quality Reporting System
will be more likely to participate in the
pilot. Therefore, based on the previously
mentioned assumptions, we do not
believe there will be any additional
impact on EPs that is specific to
participation in the pilot. EPs must
participate in the Physician Quality
Reporting System in order to participate
in the pilot.
9. Physician Feedback Program/Value
Modifier Payment
The changes to the Physician
Feedback Program in section VI.I. of this
final rule with comment period would
not impact CY 2012 physician payments
under the Physician Fee Schedule.
However, we expect that our decision to
use the Physician Quality Reporting
System quality measures in the
Physician Feedback reports and in the
value modifier to be implemented in CY
2015 may result in increased
participation in the Physician Quality
Reporting System in CY 2012. We
anticipate that as we approach
implementation of the value modifier,
physicians will increasingly participate
in the Physician Quality Reporting
System to determine and understand
how the value modifier could affect
their payments.
10. Bundling of Payments for Services
Provided to Outpatients Who Later Are
Admitted as Inpatients: 3-Day Payment
Window Policy and the Impact on
Wholly Owned or Wholly Operated
Physician Offices
Medicare collects ownership
information obtained in the 855A and
855B enrollment forms completed upon
a facility or a practitioner’s Medicare
enrollment. The 855 forms are selfselecting enrollment forms that may be
updated as necessary. The enrollment
forms do not specifically require
complete information on whether a
physician office is wholly owned or
wholly operated by a hospital. While we
believe that most hospital owned
entities providing physician services
will be considered part of the hospital
and operating as hospital outpatient
departments; there will be at least some
hospital owned or operated entities that
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will meet the definition of ‘‘whollyowned or wholly-operated’’ and will be
subject to the 3-day payment window
policy. We are unable to accurately
estimate and verify the number of
wholly owned or wholly operated
entities enrolled in Medicare and
furnishing health services to Medicare
beneficiaries that will be subject to the
3-day payment window policy under
the PFS because the 855 forms do not
explicitly capture information on sole
ownership or operation. We do not
believe that our discussion in section
V.B. of this final rule with comment
period regarding the entities to which
this policy applies changes our
assessment that this policy would
impact a small number of providers/
suppliers. We note that the application
of the 3-day window policy is limited to
diagnostic or related nondiagnostic
services that are provided during the
defined payment window by entities
that are wholly owned or operated by
the hospital to which the patient is
ultimately admitted. The 3-day payment
window policy would not apply to the
majority of services provided by a
hospital’s wholly-owned or whollyoperated physician offices. Furthermore,
the effects of applying the 3-day
window policy would be limited to the
practice expense component of the
payment rate, and the professional
component is not affected by the 3-day
window payment policy. We are unable
to estimate the impact of this final
policy at this time. However, we note
that if we were able to estimate the
effects of this policy on Part B
payments, the program savings would
be redistributed across all other services
paid under the PFS in accordance with
due to the PFS budget neutrality
provisions.
11. Clinical Laboratory Fee Schedule:
Signature on Requisition
As discussed in section VI.D. of this
final rule with comment period, we are
retracting the policy that was finalized
in the CY 2011 PFS final rule with
comment period, which required a
physician’s or NPP’s signature on a
requisition for clinical diagnostic
laboratory tests paid under the CLFS
and are reinstating our prior policy that
the signature of the physician or NPP is
not required on a requisition for a
clinical diagnostic laboratory test paid
under the CLFS for Medicare purposes.
There are no expenditures or fiscal
impact on the Medicare program
associated with this policy. While this
policy may have an effect on
beneficiaries, we believe that any effect
would be positive because we are
changing a requirement that might have
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I. Alternatives Considered
This final rule with comment period
contains a range of policies, including
some provisions related to specific
statutory provisions. The preceding
preamble provides descriptions of the
statutory provisions that are addressed,
identifies those policies when discretion
has been exercised, presents rationale
for our policies and, where relevant,
alternatives that were considered.
J. Impact on Beneficiaries
There are a number of changes in this
final rule with comment period that
would have an effect on beneficiaries. In
general, we believe that many of the
final changes, including the refinements
of the Physician Quality Reporting
System with its focus on measuring,
L. Conclusion
The analysis in the previous sections,
together with the remainder of this
preamble, provides a Final Regulatory
Flexibility Act Analysis. The previous
analysis, together with the remainder of
this preamble, provides a Regulatory
Impact Analysis.
emcdonald on DSK4SPTVN1PROD with RULES2
X. Addenda Referenced in This Final
Rule With Comment Period and
Available Only Through the Internet on
the CMS Web Site
This section lists the Addenda
referred to throughout the preamble of
this final rule with comment period.
Beginning with the CY 2012 PFS
proposed rule, the PFS Addenda A, B,
C, D, E, F, G, and H will no longer
appear in the Federal Register. In
addition, beginning with the CY 2012
PFS final rule with comment period, the
Designated Health Services Code List
(Addendum J) will no longer appear in
the Federal Register. Instead, these
Addenda, along with other
supplemental documents, will be
available through the Internet.
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submitting, and analyzing quality data
will have a positive impact and improve
the quality and value of care provided
to Medicare beneficiaries.
The regulatory provisions may affect
beneficiary liability in some cases. Most
changes in aggregate beneficiary liability
due to a particular provision would be
a function of the coinsurance (20
percent if applicable for the particular
provision after the beneficiary has met
the deductible). To illustrate this point,
as shown in Table 87, the CY 2011
national payment amount in the
nonfacility setting for CPT code 99203
(Office/outpatient visit, new) is $102.95,
which means that in CY 2011 a
beneficiary would be responsible for 20
percent of this amount, or $20.59. Based
on this final rule with comment period,
including the negative update, the CY
2012 national payment amount in the
nonfacility setting for CPT code 99203,
as shown in Table 87, is $76.23, which
means that, in CY 2012, the beneficiary
coinsurance for this service would be
$15.25. Most policies discussed in this
final rule with comment period that
impact payment rates, such as the
expansion of the MPPR to the
professional component of imaging
procedures, would similarly impact
beneficiaries’ coinsurance.
Readers who experience any problems
accessing any of the Addenda that are
posted on the CMS Web sites identified
in this section should contact Erin
Smith at (410) 786–4497.
The following PFS Addenda for CY
2012 PFS final rule with comment
period rule with are available through
the Internet on the CMS Web site at
https://www.cms.gov/
PhysicianFeeSched/. 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 2012 PFS final rule with
comment period, refer to item CMS–
1524–FC.
Addendum E—CY 2012 Geographic
Practice Cost Indices (GPCIs) by
States and Medicare Locality
Addendum F—CY 2012 Diagnostic
Imaging Services Subject to the
Multiple Procedure Payment
Reduction
Addendum G—CPT/HCPCS Imaging
Codes Defined by Section 5102(b) of
the DRA
Addendum H—CY 2011 ‘‘Always
Therapy’’ Services Subject to the
Multiple Procedure Payment
Reduction
Addendum A—Explanation and Use of
Addendum B
Addendum B—Relative Value Units and
Related Information Used in
Determining Medicare Payments for
CY 2012
Addendum C—[Reserved]
Addendum D—CY 2012 Geographic
Adjustment Factors (GAFs)
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K. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Table 89, we have
prepared an accounting statement
showing the estimated expenditures
associated with this final rule with
comment period. This estimate includes
the estimated CY 2012 incurred benefit
impact associated with the estimated CY
2012 PFS conversion factor update
based on a midsession review of the FY
2012 President’s Budget.
The Designated Health Services Code
List Addendum for CY 2012 PFS final
rule with comment period entitled
‘‘Addendum J: List of CPT 1/HCPCS
Codes Used to Define Certain
Designated Health Service Categories 2
Under Section 1877 of the Social
Security Act Effective January 1, 2012’’
is available through the Internet on the
CMS Web site at https://www.cms.gov/
PhysicianSelfReferral/
40_List_of_Codes.asp#TopOfPage.
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ER28NO11.208</GPH>
impeded access to care in some cases.
This policy does not impact payment
rates under the CLFS, or any other part
of the Medicare program.
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§ 410.15 Annual wellness visits providing
Personalized Prevention Plan Services:
Conditions for and limitations on coverage.
List of Subjects
42 CFR Part 410
Health facilities, Health professions,
Kidney diseases, Laboratories,
Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 414
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medicare,
Reporting and recordkeeping.
42 CFR Part 415
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 495
Administrative practice and
procedure, Electronic health records,
Health facilities, Health professions,
Health maintenance organizations
(HMO), Medicaid, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble of this final rule with
comment period, the Centers for
Medicare & Medicaid Services amends
42 CFR chapter IV as set forth below:
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
1. The authority citation for part 410
continues to read as follows:
■
Authority: Secs. 1102, 1834, 1871, and
1893 of the Social Security Act (42 U.S.C.
1302, 1395m, 1395hh, and 1395ddd).
2. Amend § 410.15(a) as follows:
A. Amending the definition of ‘‘First
annual wellness visit providing
personalized prevention plan services’’
by—
■ i. Revising the introductory text.
■ ii. Redesignating paragraphs (i)
through (ix) as paragraphs (ii) through
(x).
■ iii. Adding a new paragraph (i).
■ iv. Revising newly redesignated
paragraph (viii)(A).
■ B. Adding the definition of ‘‘Health
risk assessment’’.
■ C. In the definition of ‘‘Subsequent
annual wellness visit providing
personalized prevention plan services’’.
■ i. Revising the introductory text.
■ ii. Redesignating paragraphs (i)
through (vii) as paragraphs (ii) through
(viii).
■ iii. Adding a new paragraph (i).
■ iv. Revising newly redesigned
paragraphs (iii) and (vi)(B).
The revisions and additions read as
follows:
emcdonald on DSK4SPTVN1PROD with RULES2
■
■
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(a) * * *
First annual wellness visit providing
personalized prevention plan services
means the following services furnished
to an eligible beneficiary by a health
professional that include, and take into
account the results of, a health risk
assessment, as those terms are defined
in this section:
(i) Review (and administration if
needed) of a health risk assessment (as
defined in this section).
*
*
*
*
*
(viii) * * *
(A) A written screening schedule for
the individual such as a checklist for the
next 5 to 10 years, as appropriate, based
on recommendations of the United
States Preventive Services Task Force
and the Advisory Committee on
Immunization Practices, and the
individual’s health risk assessment (as
that term is defined in this section),
health status, screening history, and ageappropriate preventive services covered
by Medicare.
*
*
*
*
*
Health risk assessment means, for the
purposes of this section, an evaluation
tool that meets the following criteria:
(i) Collects self-reported information
about the beneficiary.
(ii) Can be administered
independently by the beneficiary or
administered by a health professional
prior to or as part of the AWV
encounter.
(iii) Is appropriately tailored to and
takes into account the communication
needs of underserved populations,
persons with limited English
proficiency, and persons with health
literacy needs.
(iv) Takes no more than 20 minutes to
complete.
(v) Addresses, at a minimum, the
following topics:
(A) Demographic data, including but
not limited to age, gender, race, and
ethnicity.
(B) Self assessment of health status,
frailty, and physical functioning.
(C) Psychosocial risks, including but
not limited to, depression/life
satisfaction, stress, anger, loneliness/
social isolation, pain, and fatigue.
(D) Behavioral risks, including but not
limited to, tobacco use, physical
activity, nutrition and oral health,
alcohol consumption, sexual health,
motor vehicle safety (seat belt use), and
home safety.
(E) Activities of daily living (ADLs),
including but not limited to, dressing,
feeding, toileting, grooming, physical
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ambulation (including balance/risk of
falls), and bathing.
(F) Instrumental activities of daily
living (IADLs), including but not limited
to, shopping, food preparation, using
the telephone, housekeeping, laundry,
mode of transportation, responsibility
for own medications, and ability to
handle finances.
*
*
*
*
*
Subsequent annual wellness visit
providing personalized prevention plan
services means the following services
furnished to an eligible beneficiary by a
health professional that include, and
take into account the results of an
updated health risk assessment, as those
terms are defined in this section:
(i) Review (and administration, if
needed) of an updated health risk
assessment (as defined in this section).
*
*
*
*
*
(iii) An update of the list of current
providers and suppliers that are
regularly involved in providing medical
care to the individual as that list was
developed for the first annual wellness
visit providing personalized prevention
plan services or the previous subsequent
annual wellness visit providing
personalized prevention plan services.
*
*
*
*
*
(vi) * * *
(B) The list of risk factors and
conditions for which primary,
secondary or tertiary interventions are
recommended or are underway for the
individual as that list was developed at
the first annual wellness visit providing
personalized prevention plan services or
the previous subsequent annual
wellness visit providing personalized
prevention plan services.
*
*
*
*
*
■ 3. In § 410.62 amend paragraph (b) by
revising the heading to read as follows:
§ 410.62 Outpatient speech-language
pathology services: Conditions and
exclusions.
*
*
*
*
*
(b) Condition for coverage of
outpatient speech-language pathology
services furnished to certain inpatients
of a hospital or a CAH or SNF. * * *
*
*
*
*
*
§ 410.78
[Amended]
4. In § 410.78, amend paragraph (b)
introductory text by removing the
phrase ‘‘and individual and group
health and behavior assessment and
intervention services furnished by an
interactive telecommunications system
if the following conditions are met:’’
and adding in its place the phrase
‘‘individual and group health and
behavior assessment and intervention
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Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Rules and Regulations
services, and smoking cessation services
furnished by an interactive
telecommunications system if the
following conditions are met:’’.
■ 5. Amend § 410.140 by revising the
definition of ‘‘Deemed entity’’ to read as
follows:
§ 410.140
Definitions.
*
*
*
*
*
Deemed entity means an individual,
physician, or entity accredited by an
approved organization, but that has not
yet been approved by CMS under
§ 410.145(b) to furnish training.
*
*
*
*
*
§ 410.141
[Amended]
6. Amend § 410.141(b)(1) by:
A. Removing the term ‘‘it’’ and adding
the phrase ‘‘the training’’ in its place.
■ B. Removing the cross-reference
‘‘§ 410.32(a)’’ and adding the crossreference ‘‘§ 410.32(a)(2)’’ in its place.
■
■
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
7. The authority citation for part 414
continues to read as follows:
■
Authority: Secs. 1102, 1871, and 1881(b)(l)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr(b)(l)).
8. Amend § 414.22 by revising
paragraphs (b)(5)(i)(A) through (C) to
read as follows:
■
§ 414.22
Relative value units (RVUs).
emcdonald on DSK4SPTVN1PROD with RULES2
*
*
*
*
*
(b) * * *
(5) * * *
(i) * * *
(A) Facility practice expense RVUs.
The facility practice expense RVUs
apply to services furnished to patients
in places of service including, but not
limited to, a hospital, a skilled nursing
facility, a community mental health
center, a hospice, or an ambulatory
surgical center, or in a wholly owned or
wholly operated entity providing
preadmission services under
§ 412.2(c)(5).
(B) Nonfacility practice expense
RVUs. The nonfacility practice expense
RVUs apply to services furnished to
patients in places of service including,
but not limited to, a physician’s office,
the patient’s home, a nursing facility, or
a comprehensive outpatient
rehabilitation facility (CORF).
(C) Outpatient therapy and CORF
services. Outpatient therapy services
(including physical therapy,
occupational therapy, and speechlanguage pathology services) and CORF
services billed under the physician fee
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schedule are paid using the nonfacility
practice expense RVUs.
*
*
*
*
*
§ 414.65
[Amended]
9. In § 414.65, amend paragraph (a)(1)
introductory text by removing the
phrase ‘‘and individual and group
health and behavior assessment and
intervention furnished via an interactive
telecommunications system is equal to
the current fee schedule amount
applicable for the service of the
physician or practitioner.’’ and adding
in its place the phrase ‘‘individual and
group health and behavior assessment
and intervention, and smoking cessation
services furnished via an interactive
telecommunications system is equal to
the current fee schedule amount
applicable for the service of the
physician or practitioner.’’
■
10. Amend § 414.90 as follows:
A. In paragraph (b), by revising the
definition of ‘‘Group practice’’.
■ B. In paragraph (c)(2) introductory
text, by removing the phrases ‘‘during
the applicable reporting period. For
purposes of this paragraph,’’ at the end
of the paragraph and adding the phrase
‘‘during the reporting period.’’ in its
place.
■ C. Adding paragraph (c)(4)
introductory text.
■ D. Redesignating paragraphs (c)(2)(i)
through (c)(2)(iii) as paragraphs (c)(4)(i)
through (c)(4)(iii), respectively.
■ E. Revising paragraph (f)(1).
■ F. Removing paragraph (f)(2).
■ G. Redesignating paragraph (f)(3) as
paragraph (f)(2).
■ H. Revising newly redesignated
paragraph (f)(2) introductory text.
■ I. In newly redesignated paragraph
(f)(2)(ii), removing the phrase ‘‘behalf;
or’’ and adding the phrase ‘‘behalf.’’ in
its place.
■ J. In newly redesignated paragraph
(f)(2)(iii), removing the phrase
‘‘containing real or dummy’’ and adding
in its place the phrase ‘‘containing
dummy’’.
■ K. Revising paragraphs (g)(1) and
(g)(3).
■ L. Redesignating paragraphs (g)(4) and
(g)(5) as paragraphs (g)(5) and (g)(6).
■ M. Adding a new paragraph (g)(4).
■ N. In newly redesignated paragraph
(g)(5), by removing the ‘‘.’’ and adding
‘‘; and’’ in its place.
■ O. Revising newly redesignated
paragraph (g)(6).
■ P. Revising paragraphs (i)(1) and (i)(2)
introductory text.
The revisions and additions read as
follows:
■
■
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§ 414.90 Physician Quality Reporting
System.
*
*
*
*
*
(b) * * *
Group practice means a physician
group practice, as defined by a TIN,
with 25 or more individual eligible
professionals (or, as identified by NPIs)
who have reassigned their billing rights
to the TIN.
*
*
*
*
*
(c) * * *
*
*
*
*
*
(2) For purposes of this paragraph—
*
*
*
*
*
(4) For purposes of this paragraph—
*
*
*
*
*
(f) * * *
(1) Reporting periods. For purposes of
this paragraph, the reporting period is—
(i) The 12-month period from January
1 through December 31 of such program
year.
(ii) A 6-month period from July 1
through December 31 of such program
year.
(A) For 2011, such 6-month reporting
period is not available for EHR-based
reporting of individual Physician
Quality Reporting System quality
measures.
(B) For 2012 and subsequent program
years, such 6-month reporting period
from July 1 through December 31 of
such program year is only available for
registry-based reporting of Physician
Quality Reporting System measures
groups by eligible professionals.
(2) Reporting mechanisms. For
program year 2011 and subsequent
program years, an eligible professional
who wishes to participate in the
Physician Quality Reporting System
must report information on the
individual Physician Quality Reporting
System quality measures or Physician
Quality Reporting System measures
groups identified by CMS in one of the
following manners:
(g) * * *
(1) Meets the participation
requirements specified by CMS for the
Physician Quality Reporting System
group practice reporting option;
*
*
*
*
*
(3) Reports measures in the form and
manner specified by CMS;
(4) For purposes of paragraph (g), the
reporting period is the 12-month period
from January 1 through December 31 of
such program year;
*
*
*
*
*
(6) Payments to a group practice
under this paragraph must be in lieu of
the payments that would otherwise be
made under the Physician Quality
Reporting System to eligible
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professionals in the group practice for
meeting the criteria for satisfactory
reporting for individual eligible
professionals.
(i) If an eligible professional, as
identified by an individual NPI, has
reassigned his or her Medicare billing
rights to a TIN selected to participate in
the Physician Quality Reporting System
group practice reporting option for a
program year, then for that program year
the eligible professional must
participate in the Physician Quality
Reporting System via the group practice
reporting option. For any program year
in which the TIN is selected to
participate in the Physician Quality
Reporting System group practice
reporting option, the eligible
professional cannot individually qualify
for a Physician Quality Reporting
System incentive payment by meeting
the requirements specified in paragraph
(f) of this section.
(ii) If, for the program year, the
eligible professional participates in the
Physician Quality Reporting System
under a TIN that is not selected to
participate in the Physician Quality
Reporting System group practice
reporting option for that program year,
then the eligible professional may
individually qualify for a Physician
Quality Reporting System incentive by
meeting the requirements specified in
paragraph (f) of this section under that
TIN.
*
*
*
*
*
(i) * * *
(1) To request an informal review, an
eligible professional (or in the case of
reporting under paragraph (g) of this
section, group practices) must submit a
request to CMS within 90 days of the
release of the feedback reports. The
request must be submitted in writing
and summarize the concern(s) and
reasons for requesting an informal
review and may also include
information to assist in the review.
(2) CMS will provide a written
response within 90 days of the receipt
of the original request.
*
*
*
*
*
■ 11. Amend§ 414.92 as follows:
■ A. In paragraph (b), by adding the
definition of ‘‘Certified electronic health
record technology’’.
■ B. In paragraph (b), in the definition
of ‘‘Group practice,’’ by redesignating
paragraphs (i), (ii)(A), and (ii)(B) as
paragraphs (i)(A), (i)(B) and (ii),
respectively.
■ C. In paragraph (b), in the definition
of ‘‘Group practice,’’ by revising newly
redesginated paragraph (i)(B).
■ D. In paragraph (c)(2) introductory
text, by revising the paragraph heading.
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E. In paragraph (c)(2)(ii) introductory
text, removing the phrase ‘‘significant
hardship exemption from the 2012 eRx
payment adjustment if one of the
following circumstances apply:’’ and
adding the phrase ‘‘significant hardship
exemption from a eRx payment
adjustment if one of the following
circumstances apply:’’ in its place.
■ F. Redesignating paragraphs
(c)(2)(ii)(A) through (F) as paragraphs
(c)(2)(ii)(A)(1) through (c)(2)(ii)(A)(6),
respectively.
■ G. Adding paragraphs (c)(2)(ii)(A)
introductory text, (c)(2)(ii)(B), and (c)(2)
(iii).
■ H. In paragraph (d) introductory text,
by removing the phrase ‘‘must meet the
criteria for successful’’ and the phrase
‘‘must meet the criteria for being a
successful’’ is added in its place.
■ I. In paragraph (d)(1), by removing the
phrase ‘‘For purposes of this paragraph
in 2011,’’ is removed and adding in its
place the phrase ‘‘For purposes of this
paragraph,’’.
■ J. In paragraph (d)(2) introductory
text, by removing the phrase ‘‘For
program year 2011, an eligible
professional’’ and adding the phrase
‘‘An eligible professional’’ in its place.
■ K. In paragraph (e)(2)(ii), by removing
the phrase ‘‘under another TIN’’ and
adding the phrase ‘‘under a TIN’’ in its
place.
■ L. Redesignating paragraph (f) as (g).
■ M. Adding a new paragraph (f).
■ The revisions and additions read as
follows:
■
§ 414.92 Electronic Prescribing Incentive
Program.
*
*
*
*
*
(b) * * *
Certified electronic health record
technology means an electronic health
record vendor’s product and version as
described in 45 CFR 170.102.
Group practice
*
*
*
*
*
(i) * * *
(B) In a Medicare-approved
demonstration project or other Medicare
program, under which Physician
Quality Reporting System requirements
and incentives have been incorporated;
and
*
*
*
*
*
(c) * * *
(2) Payment adjustment.* * *
(ii) * * *
(A) From the 2012 payment
adjustments by meeting one of the
following:
*
*
*
*
*
(B) From the 2013 and 2014 payment
adjustments by meeting one of the
following:
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(1) The eligible professional or group
practice is located in a rural area
without high speed internet access.
(2) The eligible professional or group
practice is located in an area without
sufficient available pharmacies for
electronic prescribing.
(3) The eligible professional or group
practice is unable to electronically
prescribe due to local, State, or Federal
law or regulation.
(4) The eligible professional or group
practice has limited prescribing activity,
as defined by an eligible professional
generating fewer than 100 prescriptions
during a 6-month reporting period.
(iii) Other limitations to the payment
adjustment. An eligible professional (or
in the case of a group practice under
paragraph (b) of this section, a group
practice) is exempt from the application
of the payment adjustment under
paragraph (c)(2) of this section if one of
the following applies:
(A) The eligible professional is not an
MD, DO, podiatrist, nurse practitioner,
or physician assistant.
(B) The eligible professional does not
have at least 100 cases containing an
encounter code that falls within the
denominator of the electronic
prescribing measure for dates of service
during the 6-month reporting period
specified in paragraph (f)(1) of this
section.
*
*
*
*
*
(f) Requirements for individual
eligible professionals and group
practices for the payment adjustment. In
order to be considered a successful
electronic prescriber for the electronic
prescribing payment adjustment, an
individual eligible professional (or, in
the case of a group practice under
paragraph (b) of this section, a group
practice), as identified by a unique TIN/
NPI combination, must meet the criteria
for being a successful electronic
prescriber specified by CMS, in the form
and manner specified in paragraph (f)(2)
of this section, and during the reporting
period specified in paragraph (f)(1) of
this section.
(1) Reporting periods. (i) For purposes
of this paragraph (f), the reporting
period for the 2013 payment adjustment
is either of the following:
(A) The 12-month period from
January 1, 2011 through December 31,
2011.
(B) The 6-month period from January
1, 2012 through June 30, 2012.
(ii) For purposes of this paragraph (f),
the reporting period for the 2014
payment adjustment is either of the
following:
(A) The 12-month period from
January 1, 2012 through December 31,
2012.
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(B) The 6-month period from January
1, 2013 through June 30, 2013.
(2) Reporting mechanisms. An eligible
professional (or, in the case of a group
practice under paragraph (e) of this
section, a group practice) who wishes to
participate in the Electronic Prescribing
Incentive Program must report
information on the electronic
prescribing measure identified by CMS
to one of the following:
(i) For the 6- and 12-month reporting
periods under paragraph (f)(1) of this
section, CMS, by no later than 2 months
after the end of the applicable 12-month
reporting period or by no later than 1
month after the end of the applicable 6month reporting period, on the eligible
professional’s Medicare Part B claims
for covered professional services
furnished by the eligible professional
during the reporting period specified in
paragraph (f)(1) of this section.
(ii) For the 12-month reporting period
under paragraph (f)(1) of this section, a
qualified registry (as defined in
paragraph (b) of this section) in the form
and manner and by the deadline
specified by the qualified registry
selected by the eligible professional.
The selected qualified registry submits
information, as required by CMS, for
covered professional services furnished
by the eligible professional during the
reporting period specified in paragraph
(f)(1) of this section to CMS on the
eligible professional’s behalf.
(iii) For the 12-month reporting
period under paragraph (f)(1) of this
section, CMS by extracting clinical data
using a secure data submission method,
as required by CMS, from a qualified
electronic health record product (as
defined in paragraph (b) of this section)
by the deadline specified by CMS for
covered professional services furnished
by the eligible professional during the
reporting period specified in paragraph
(f)(1) of this section. Prior to actual data
submission for a given program year and
by a date specified by CMS, the eligible
professional must submit a test file
containing dummy clinical quality data
extracted from the qualified electronic
health record product selected by the
eligible professional using a secure data
submission method, as required by
CMS.
*
*
*
*
*
■ 12. In § 414.802 amend the definition
of ‘‘Unit’’ by revising the first sentence
to reads as follows:
§ 414.802
Definitions.
*
*
*
*
*
Unit means the product represented
by the 11-digit National Drug Code,
unless otherwise specified by CMS to
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account for situations where labeling
indicates that the amount of drug
product represented by a National Drug
Code varies. * * *
*
*
*
*
*
■ 13. Amend § 414.904 by revising
paragraph (d)(3) to read as follows:
§ 414.904 Average sales price as the basis
for payment.
*
*
*
*
*
(d) * * *
(3) Widely available market price and
average manufacturer price. If the
Inspector General finds that the average
sales price exceeds the widely available
market price or the average
manufacturer price by the applicable
threshold percentage specified in
paragraph (d)(3)(iii) or (iv) of this
section, the Inspector General is
responsible for informing the Secretary
(at such times as specified by the
Secretary) and the payment amount for
the drug or biological will be substituted
subject to the following adjustments:
(i) The payment amount substitution
will be applied at the next average sales
price payment amount calculation
period after the Inspector General
informs the Secretary (at such times
specified by the Secretary) about billing
codes for which the average sales price
has exceeded the average manufacturer
price by the applicable threshold
percentage, and will remain in effect for
1 quarter after publication.
(ii) Payment at 103 percent of the
average manufacturer price for a billing
code will be applied at such times
when—
(A) The threshold for making price
substitutions, as defined in paragraph
(d)(3)(iii) of this section is met; and
(B) 103 percent of the average
manufacturer price is less than the 106
percent of the average sales price for the
quarter in which the substitution would
be applied.
(iii) The applicable percentage
threshold for average manufacturer
price comparisons for CYs 2005 through
2011 is 5 percent. For CY 2012, the
applicable percentage threshold for
average sales price comparisons is
reached when—
(A) The average sales price for the
billing code has exceeded the average
manufacturer price for the billing code
by 5 percent or more in 2 consecutive
quarters, or 3 of the previous 4 quarters
immediately preceding the quarter to
which the price substitution would be
applied; and
(B) The average manufacturer price
for the billing code is calculated using
the same set of National Drug Codes
used for the average sales price for the
billing code.
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73473
(iv) The applicable percentage
threshold for widely available market
price comparisons for CYs 2005 through
2012 is 5 percent.
*
*
*
*
*
PART 415—SERVICES FURNISHED BY
PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN
TEACHING SETTINGS, AND
RESIDENTS IN CERTAIN SETTINGS
14. The authority citation for part 415
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
§ 415.130
[Amended]
15. In § 415.130, amend paragraphs
(d)(1) and (d)(2) by removing the date
‘‘December 31, 2010’’ and adding the
date ‘‘December 31, 2011’’ in its place.
■
PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
16. The authority citation for part 495
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
17. Amend § 495.8 as follows:
A. In paragraph (a)(2)(ii), by removing
the phrase ‘‘selected by CMS
electronically to CMS (or in the case of
Medicaid EPs, the States) in the manner
specified by CMS (or in the case of
Medicaid EPs, the States).’’ and adding
the phrase ‘‘selected by CMS to CMS (or
in the case of Medicaid EPs, the States)
in the form and manner specified by
CMS (or in the case of Medicaid EPs, the
States).’’ in its place.
■ B. Adding a new paragraph (a)(2)(v) to
read as follows:
■
■
§ 495.8 Demonstration of meaningful use
criteria.
(a) * * *
(2) * * *
(v) Exception for Medicare EPs for PY
2012—Participation in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot. In order to satisfy
the clinical quality measure reporting
objective in § 495.6(d)(10), aside from
attestation, an EP participating in the
Physician Quality Reporting System
may also participate in the Physician
Quality Reporting System-Medicare
EHR Incentive Pilot through one of the
following methods:
(A) Submission of data extracted from
the EP’s certified EHR technology
through a Physician Quality Reporting
System qualified EHR data submission
vendor; or
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(B) Submission of data extracted from
the EP’s certified EHR technology,
which must also be through a Physician
Quality Reporting System qualified
EHR.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: October 26, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: October 31, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2011–28597 Filed 11–1–11; 4:15 pm]
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BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Rules and Regulations]
[Pages 73026-73474]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28597]
[[Page 73025]]
Vol. 76
Monday,
No. 228
November 28, 2011
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 410, 414, 415, et al.
Medicare Program; Payment Policies Under the Physician Fee Schedule,
Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee
Schedule: Signature on Requisition, and Other Revisions to Part B for
CY 2012; Final Rule
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 /
Rules and Regulations
[[Page 73026]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410, 414, 415, and 495
[CMS-1524-FC and CMS-1436-F]
RINs 0938-AQ25 and 0938-AQ00
Medicare Program; Payment Policies Under the Physician Fee
Schedule, Five-Year Review of Work Relative Value Units, Clinical
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions
to Part B for CY 2012
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This final rule with comment period addresses changes to the
physician fee schedule and other Medicare Part B payment policies to
ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services. It also addresses,
implements or discusses certain statutory provisions including
provisions of the Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act of 2010
(collectively known as the Affordable Care Act) and the Medicare
Improvements for Patients and Providers Act (MIPPA) of 2008. In
addition, this final rule with comment period discusses payments for
Part B drugs; Clinical Laboratory Fee Schedule: Signature on
Requisition; Physician Quality Reporting System; the Electronic
Prescribing (eRx) Incentive Program; the Physician Resource-Use
Feedback Program and the value modifier; productivity adjustment for
ambulatory surgical center payment system and the ambulance, clinical
laboratory, and durable medical equipment prosthetics orthotics and
supplies (DMEPOS) fee schedules; and other Part B related issues.
DATES: Effective date: These regulations are effective on January 1,
2012.
Implementation date: The 3-day payment window policy provisions
specified in section V.B.3.a. of this final rule with comment period
will be implemented by July 1, 2012.
Comment date: To be assured consideration, comments on the items
listed in the ``Comment Subject Areas'' section of this final rule with
comment period must be received at one of the addresses provided below,
no later than 5 p.m. Eastern Standard Time on January 3, 2012.
ADDRESSES: In commenting, please refer to file code CMS-1524-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://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-1524-FC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1524-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building is
not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-1066 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: Ryan Howe, (410) 786-3355 or Chava
Sheffield, (410) 786-2298, for issues related to the physician fee
schedule practice expense methodology and direct practice expense
inputs.
Elizabeth Truong, (410) 786-6005, or Sara Vitolo, (410) 786-5714,
for issues related to potentially misvalued services and interim final
work RVUs.
Ken Marsalek, (410) 786-4502, for issues related the multiple
procedure payment reduction and pathology services.
Sara Vitolo, (410) 786-5714, for issues related to malpractice
RVUs.
Michael Moore, (410) 786-6830, for issues related to geographic
practice cost indices.
Ryan Howe, (410) 786-3355, for issues related to telehealth
services.
Elizabeth Truong, (410) 786-6005, for issues related to the
sustainable growth rate, or the anesthesia or physician fee schedule
conversion factors.
Bonny Dahm, (410) 786-4006, for issues related to payment for
covered outpatient drugs and biologicals.
Glenn McGuirk, (410) 786-5723, for issues related to the Clinical
Laboratory Fee Schedule (CLFS) signature on requisition policy.
Claudia Lamm, (410) 786-3421, for issues related to the
chiropractic services demonstration budget neutrality issue.
Jamie Hermansen, (410) 786-2064, or Stephanie Frilling, (410) 786-
4507 for issues related to the annual wellness visit.
Christine Estella, (410) 786-0485, for issues related to the
Physician Quality Reporting System, incentives for Electronic
Prescribing (eRx) and Physician Compare.
Gift Tee, (410) 786-9316, for issues related to the Physician
Resource Use Feedback Program and physician value modifier.
Stephanie Frilling, (410) 786-4507 for issues related to the 3-day
payment window.
Pam West, (410) 786-2302, for issues related to the technical
corrections or the therapy cap.
Rebecca Cole or Erin Smith, (410) 786-4497, for issues related to
physician payment not previously identified.
SUPPLEMENTARY INFORMATION:
Comment Subject Areas: We will consider comments on the following
subject areas discussed in this final rule with comment period that are
received by the date and time indicated in the DATES section of this
final rule with comment period:
[[Page 73027]]
(1) The interim final work, practice expense, and malpractice RVUs
(including the physician time, direct practice expense (PE) inputs, and
the equipment utilization rate assumption) for new, revised,
potentially misvalued, and certain other CY 2012 HCPCS codes. These
codes and their CY 2012 interim final RVUs are listed in Addendum C to
this final rule with comment period.
(2) The physician self-referral designated health services codes
listed in Tables 83 and 84.
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 regulations.gov
Web site (https://www.regulations.gov) as soon as possible after they
have been received. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-(800) 743-3951.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a table of contents. Some of the issues
discussed in this preamble affect the payment policies, but do not
require changes to the regulations in the Code of Federal Regulations
(CFR). Information on the regulations' impact appears throughout the
preamble and, therefore, is not discussed exclusively in section IX. of
this final rule with comment period.
I. Background
A. Development of the Relative Value System
1. Work RVUs
2. Practice Expense Relative Value Units (PE RVUs)
3. Resource-Based Malpractice RVUs
4. Refinements to the RVUs
5. Application of Budget Neutrality to Adjustments of RVUs
B. Components of the Fee Schedule Payment Amounts
C. Most Recent Changes to Fee Schedule
II. Provisions of the Rule for the Physician Fee Schedule
A. Resource-Based Practice Expense (PE) Relative Value Units
(RVUs)
1. Overview
2. Practice Expense Methodology
a. Direct Practice Expense
b. Indirect Practice Expense per Hour Data
c. Allocation of PE to Services
(1) Direct Costs
(2) Indirect Costs
d. Facility and Nonfacility Costs
e. Services With Technical Components (TCs) and Professional
Components (PCs)
f. PE RVU Methodology
(1) Setup File
(2) Calculate the Direct Cost PE RVUs
(3) Create the Indirect Cost PE RVUs
(4) Calculate the Final PE RVUs
(5) Setup File Information
(6) Equipment Cost per Minute
3. Changes to Direct PE Inputs
a. Inverted Equipment Minutes
b. Labor and Supply Input Duplication
c. AMA RUC Recommendations for Moderate Sedation Direct PE
Inputs
d. Updates to Price and Useful Life for Existing Direct Inputs
4. Development of Code-Specific PE RVUs
5. Physician Time for Select Services
B. Potentially Misvalued Services Under the Physician Fee
Schedule
1. Valuing Services Under the PFS
2. Identifying, Reviewing, and Validating the RVUs of
Potentially Misvalued Services Under the PFS
a. Background
b. Progress in Identifying and Reviewing Potentially Misvalued
Codes
c. Validating RVUs of Potentially Misvalued Codes
3. Consolidating Reviews of Potentially Misvalued Codes
4. Public Nomination Process
5. CY 2012 Identification and Review of Potentially Misvalued
Services
a. Code Lists
b. Specific Codes
(1) Codes Potentially Requiring Updates to Direct PE Inputs
(2) Codes Without Direct Practice Expense Inputs in the Non-
Facility Setting
(3) Codes Potentially Requiring Updates to Physician Work
6. Expanding the Multiple Procedure Payment Reduction (MPPR)
Policy
a. Background
b. CY 2012 Expansion of the MPPR Policy to the Professional
Component of Advance Imaging Services
c. Further Expansion of MPPR Policies Under Consideration for
Future Years
d. Procedures Subject to the OPPS Cap
C. Overview of the Methodology for Calculation of Malpractice
RVUs
D. Geographic Practice Cost Indices (GPCIs)
1. Background
2. GPCI Revisions for CY 2012
a. Physician Work GPCIs
b. Practice Expense GPCIs
(1) Affordable Care Act Analysis and Revisions for PE GPCIs
(A) General Analysis for the CY 2012 PE GPCIs
(B) Analysis of ACS Rental Data
(C) Employee Wage Analysis
(D) Purchased Services Analysis
(E) Determining the PE GPCI Cost Share Weights
(i) Practice Expense
(ii) Employee Compensation
(iii) Office Rent
(iv) Purchased Services
(v) Equipment, Supplies, and Other Miscellaneous Expenses
(vi) Physician Work and Malpractice GPCIs
(F) PE GPCI Floor for Frontier States
(2) Summary of CY 2012 PE Proposal
c. Malpractice GPCIs
d. Public Comments and CMS Responses Regarding the CY 2012
Proposed Revisions to the 6th GPCI Update
e. Summary of CY 2012 Final GPCIs
3. Payment Localities
4. Report From the Institute of Medicine
E. Medicare Telehealth Services for the Physician Fee Schedule
1. Billing and Payment for Telehealth Services
a. History
b. Current Telehealth Billing and Payment Policies
2. Requests for Adding Services to the List of Medicare
Telehealth Services
3. Submitted Requests for Addition to the List of Telehealth
Services for CY 2012
a. Smoking Cessation Services
b. Critical Care Services
c. Domiciliary or Rest Home Evaluation and Management Services
d. Genetic Counseling Services
e. Online Evaluation and Management Services
f. Data Collection Services
g. Audiology Services
4. The Process for Adding HCPCS Codes as Medicare Telehealth
Services
5. Telehealth Consultations in Emergency Departments
6. Telehealth Originating Site Facility Fee Payment Amount
Update
III. Addressing Interim Final Relative Value Units From CY 2011
and Establishing Interim Relative Value Units for CY 2012
A. Methodology
B. Finalizing CY 2011 Interim and Proposed Values for CY 2012
1. Finalizing CY 2011 Interim and Proposed Work Values for CY
2012
a. Refinement Panel
(1) Refinement Panel Process
(2) Proposed and Interim Final Work RVUs Referred to the
Refinement Panels in CY 2011
b. Code-Specific Issues
(1) Integumentary System: Skin, Subcutaneous, and Accessory
Structures (CPT Codes 10140-11047) and Active Wound Care Management
(CPT Codes 97597 and 97598)
(2) Integumentary System: Nails (CPT Codes 11732-11765)
(3) Integumentary System: Repair (Closure) (CPT Codes 11900-
11901, 12001-12018, 12031-13057, 13100-13101, 15120-15121, 15260,
15732, 15832))
(4) Integumentary System: Destruction (CPT Codes 17250-17286)
(5) Integumentary System: Breast (CPT Codes 19302-19357)
(6) Musculoskeletal: Spine (Vertebral Column) (CPT Codes 22315-
22851)
[[Page 73028]]
(7) Musculoskeletal: Forearm and Wrist (CPT Codes 25116-25605)
(8) Musculoskeletal: Femur (Thigh Region) and Knee Joint (CPT
Codes 27385-27530)
(9) Musculoskeletal: Leg (Tibia and Fibula) and Ankle Joint (CPT
Codes 27792)
(10) Musculoskeletal: Foot and Toes (CPT Codes 28002-28825)
(11) Musculoskeletal: Application of Casts and Strapping (CPT
Codes 29125-29916)
(12) Respiratory: Lungs and Pleura (CPT Codes 32405-32854)
(13) Cardiovascular: Heart and Pericardium (CPT Codes 33030-
37766)
(14) Digestive: Salivary Glands and Ducts (CPT Codes 42415-
42440)
(15) Digestive: Esophagus (CPT Codes 43262-43415)
(16) Digestive: Rectum (CPT Codes 45331)
(17) Digestive: Biliary Tract (CPT Codes 47480-47564)
(18) Digestive: Abdomen, Peritoneum, and Omentum (CPT Codes
49082-49655)
(19) Urinary System: Bladder (CPT Codes 51705-53860)
(20) Female Genital System: Vagina (CPT Codes 57155-57288)
(21) Maternity Care and Delivery (CPT Codes 59400-59622)
(22) Endocrine System: Thyroid Glad (CPT Codes 60220-60240)
(23) Endocrine System: Parathyroid, Thymus, Adrenal Glands,
Pancreas, and Cartoid Body (CPT Codes 60500)
(24) Nervous System: Skull, Meninges, Brain and Extracranial
Peripheral Nerves and Autonomic Nervous System (CPT Codes 61781-
61885, 64405-64831)
(25) Nervous system: Spine and Spinal Cord (CPT Codes 62263-
63685)
(26) Eye and Ocular Adnexa: Eyeball (CPT Codes 65285)
(27) Eye and Ocular Adnexa: Posterior Segment (CPT Codes 67028)
(28) Diagnostic Radiology: Chest, Spine, and Pelvis (CPT Codes
71250, 72114-72131)
(29) Diagnostic Radiology: Upper Extremities (CPT Codes 73080-
73700)
(30) Diagnostic Ultrasound: Extremities (CPT Codes 76881-76882)
(31) Radiation Oncology: Radiation Treatment Management (CPT
Codes 77427-77469)
(32) Nuclear Medicine: Diagnostic (CPT Codes 78226-78598)
(33) Pathology and Laboratory: Urinalysis (CPT Codes 88120-
88177)
(34) Immunization Administration for Vaccines/Toxoids (CPT Codes
90460-90461)
(35) Gastroenterology (CPT Codes 91010-91117)
(36) Opthalmology: Special Opthalmological Services (CPT Codes
92081-92285)
(37) Special Otorhinolaryngologic Services (CPT Codes 92504-
92511)
(38) Special Otorhinolaryngologic Services: Evaluative and
Therapeutic Services (CPT Codes 92605-92618)
(39) Cardiovascular: Therapeutic Services and Procedures (CPT
Codes 92950)
(40) Neurology and Neuromuscular Procedures: Sleep Testing (CPT
Codes 95800-95811)
(41) Osteopathic Manipulative Treatment (CPT Codes 98925-98929)
(42) Evaluation and Management: Initial Observation Care (CPT
Codes 99218-99220)
(43) Evaluation and Management: Subsequent Observation Care (CPT
Codes 99224-99226)
(44) Evaluation and Management: Subsequent Hospital Care (CPT
Codes 99234-99236)
2. Finalizing CY 2011 Interim Direct PE RVUs for CY 2012
a. Background and Methodology
b. Common Refinements
(1) General Equipment Time
(2) Supply and Equipment Items Missing Invoices
c. Code-Specific Direct PE Inputs
(1) CT Abdomen and Pelvis
(2) Endovascular Revascularization
(3) Nasal/Sinus Endoscopy
(4) Insertion of Intraperitoneal Catheter
(5) In Situ Hybridization Testing
(6) External Mobile Cardivascular Telemetry
3. Finalizing CY 2011 Interim Final and CY 2012 Proposed
Malpractice RVUs
a. Finalizing CY 2011 Interim Final Malpractice RVUs
b. Finalizing CY 2012 Proposed Malpractice RVUs, Including
Malpractice RVUs for Certain Cardiothoracic Surgery Services
4. Payment for Bone Density Tests
5. Other New, Revised, or Potentially Misvalued Codes With CY
2011 Interim Final RVUs or CY 2012 Proposed RVUs Not Specifically
Discussed in the CY 2012 Final Rule With Comment Period
C. Establishing Interim Final RVUs for CY 2012
1. Establishing Interim Final Work RVUs for CY 2012
a. Code-Specific Issues
(1) Integumentary System: Skin, Subcutaneous, and Accessory
Structures (CPT Codes 10060-10061, 11056)
(2) Integumentary System: Nails (CPT Codes 11719-11721, and
G0127)
(3) Integumentary System: Repair (Closure) (CPT Codes 15271-
15278, 16020, 16025)
(4) Musculoskeletal: Hand and Fingers (CPT Codes 26341)
(5) Musculoskeletal: Application of Casts and Strapping (CPT
Codes 29125-29881)
(6) Musculoskeletal: Endoscopy/Arthroscopy (CPT codes 29826,
29880, 29881)
(7) Respiratory: Lungs and Pleura (CPT Codes 32096-32674)
(8) Cardiovascular: Heart and Pericardium (CPT Codes 33212-
37619)
(A) Pediatric Cardiovascular Code (CPT Code 36000)
(B) Renal Angiography codes (CPT Codes 36251-36254)
(C) IVC Transcatheter Procedures (CPT Codes 37191-37193)
(9) Hemic and Lymphatic: General (CPT Codes 38230-38232)
(10) Digestive: Liver (CPT Codes 47000)
(11) Digestive: Abdomen, Peritoneum, and Omentum (CPT Codes
49082-49084)
(12) Nervous system: Spine and Spinal Cord (CPT Codes 62263-
63685)
(13) Nervous System: Extracranial Nerves, Peripheral Nerves, and
Autonomic Nervous System (CPT Codes 64633-64636)
(14) Diagnostic Radiology: Abdomen (CPT Codes 74174-74178)
(15) Pathology and Laboratory: Cytopathology (CPT Codes 88101-
88108)
(16) Psychiatry: Psychiatric Therapeutic Procedures (CPT Codes
90854, 90867-98069)
(17) Opthalmology: Special Opthalmological Services (CPT Codes
92071-92072)
(18) Special Otorhinolaryngologic Services: Audologic Function
Tests (CPT Codes 92558-92588)
(19) Special Otorhinolaryngologic Services: Evaluative and
Therapeutic Services (CPT Codes 92605 and 92618)
(20) Cardiovascular: Cardiac Catheterization (CPT Codes 93451-
93568)
(21) Pulmonary: Other Procedures (CPT Codes 94060-94781)
(22) Neurology and Neuromuscular Procedures: Nerve Conduction
Tests (CPT Codes 95885-95887)
(23) Neurology and Neuromuscular Procedures: Autonomic Function
Tests (CPT Codes 95938-95939)
(24) Other CY 2012 New, Revised, and Potentially Misvalued CPT
Codes Not Specifically Discussed Previously
2. Establishing Interim Final Direct PE RVUs for CY 2012
3. Establishing Interim Final Malpractice RVUs for CY 2012
IV. Allowed Expenditures for Physicians' Services and the
Sustainable Growth Rate
A. Medicare Sustainable Growth Rate (SGR)
1. Physicians' Services
2. Preliminary Estimate of the SGR for 2012
3. Revised Sustainable Growth Rate for CY 2011
4. Final Sustainable Growth Rate for CY 2010
5. Calculation of CYs 2012, 2011, and 2010 Sustainable Growth
Rates
a. Detail on the CY 2012 SGR
(1) Factor 1--Changes in Fees for Physicians' Services (Before
Applying Legislative Adjustments) for CY 2012
(2) Factor 2--The Percentage Change in the Average Number of
Part B Enrollees From CY 2011 to CY 2012
(3) Factor 3--Estimated Real Gross Domestic Product Per Capita
Growth in 2012
(4) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2012
Compared With CY 2011
b. Detail on the CY 2011 SGR
(1) Factor 1--Changes in Fees for Physicians' Services (Before
Applying Legislative Adjustments) for CY 2011
(2) Factor 2--The Percentage Change in the Average Number of
Part B Enrollees From CY 2010 to CY 2011
(3) Factor 3--Estimated Real Gross Domestic Product Per Capita
Growth in CY 2011
[[Page 73029]]
(4) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2011
Compared With CY 2010
c. Detail on the CY 2010 SGR
(1) Factor 1--Changes in Fees for Physicians' Services (Before
Applying Legislative Adjustments) for CY 2010
(2) Factor 2--The Percentage Change in the Average Number of
Part B Enrollees From CY 2009 to CY 2010
(3) Factor 3--Estimated Real Gross Domestic Product Per Capita
Growth in CY 2010
(4) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2010
Compared With CY 2009
B. The Update Adjustment Factor (UAF)
1. Calculation Under Current Law
C. The Percentage Change in the Medicare Economic Index (MEI)
D. Physician and Anesthesia Fee Schedule Conversion Factors for
CY 2012
1. Physician Fee Schedule Update and Conversion Factor
a. CY 2012 PFS Update
b. CY 2011 PFS Conversion Factor
2. Anesthesia Conversion Factor
V. Other PFS Issues
A. Section 105: Extension of Payment for Technical Component of
Certain Physician Pathology Services
B. Bundling of Payments for Services Provided to Outpatients Who
Later Are Admitted as Inpatients: 3-Day Payment Window Policy and
the Impact on Wholly Owned or Wholly Operated Physician Practices
1. Introduction
2. Background
3. Applicability of the 3-Day Payment Window Policy for Services
Furnished in Physician Practices
a. Payment Methodology
b. Identification of Wholly Owned or Wholly Operated Physician
Practices
C. Medicare Therapy Caps
VI. Other Provisions of the Final Rule
A. Part B Drug Payment: Average Sales Price (ASP) Issues
1. Widely Available Market Price (WAMP)/Average Manufacturer
Price
2. AMP Threshold and Price Substitutions
a. AMP Threshold
b. AMP Price Substitution
(1) Inspector General Studies
(2) Proposal
(3) Timeframe for and Duration of Price Substitutions
(4) Implementation of AMP-Based Price Substitution and the
Relationship of ASP to AMP
3. ASP Reporting Update
a. ASP Reporting Template Update
b. Reporting of ASP Units and Sales Volume for Certain Products
4. Out of Scope Comments
B. Discussion of Budget Neutrality for the Chiropractic Services
Demonstration
C. Productivity Adjustment for the Ambulatory Surgical Center
Payment System, and the Ambulance, Clinical Laboratory and DMEPOS
Fee Schedules
D. Clinical Laboratory Fee schedule: Signature on Requisition
1. History and Overview
2. Proposed Changes
E. Section 4103 of the Affordable Care Act: Medicare Coverage
and Payment of the Annual Wellness Visit Providing a Personalized
Prevention Plan Under Medicare Part B
1. Incorporation of a Health Risk Assessment as Part of the
Annual Wellness Visit
a. Background and Statutory Authority--Medicare Part B Coverage
of an Annual Wellness Visit Providing Personalized Prevention Plan
Services
b. Implementation
(1) Definition of a ``Health Risk Assessment''
(2) Changes to the Definitions of First Annual Wellness Visit
and Subsequent Annual Visit
(3) Additional Comments
(4) Summary
2. The Addition of a Health Risk Assessment as a Required
Element for the Annual Wellness Visit Beginning in 2012
a. Payment for AWV Services With the Inclusion of an HRA Element
F. Quality Reporting Initiatives
1. Physician Payment, Efficiency, and Quality Improvements--
Physician Quality Reporting System
a. Program Background and Statutory Authority
b. Methods of Participation
(1) Individual Eligible Professionals
(2) Group Practices
(A) Background and Authority
(B) Definition of Group Practice
(C) Process for Physician Group Practices To Participate as
Group Practices
c. Reporting Period
d. Reporting Mechanisms--Individual Eligible Professionals
(1) Claims-Based Reporting
(2) Registry-Based Reporting
(A) Requirements for the Registry-Based Reporting Mechanism--
Individual Eligible Professionals
(B) 2012 Qualification Requirements for Registries
(3) EHR-Based Reporting
(A) Direct EHR-Based Reporting
(i) Requirements for the Direct EHR-Based Reporting Mechanism--
Individual Eligible Professionals
(ii) 2012 Qualification Requirements for Direct EHR-Based
Reporting Products
(B) EHR Data Submission Vendors
(i) Requirements for EHR Data Submission Vendors Based on
Reporting Mechanism--Individual Eligible Professionals
(ii) 2012 Qualification Requirements for EHR Data Submission
Vendors
(C) Qualification Requirements for Direct EHR-Based Reporting
Data Submission Vendors and Their Products for the 2013 Physician
Quality Reporting System
e. Incentive Payments for the 2012 Physician Quality Reporting
System
(1) Criteria for Satisfactory Reporting of Individual Quality
Measures for Individual Eligible Professionals via Claims
(2) 2012 Criteria for Satisfactory Reporting of Individual
Quality Measures for Individual Eligible Professionals via Registry
(3) Criteria for Satisfactory Reporting of Individual Quality
Measures for Individual Eligible Professionals via EHR
(4) Criteria for Satisfactory Reporting of Measures Groups via
Claims--Individual Eligible Professionals
(5) 2012 Criteria for Satisfactory Reporting of Measures Groups
via Registry--Individual Eligible Professionals
(6) 2012 Criteria for Satisfactory Reporting on Physician
Quality Reporting System Measures by Group Practices Under the GPRO
f. 2012 Physician Quality Reporting System Measures
(1) Statutory Requirements for the Selection of 2012 Physician
Quality Reporting System Measures
(2) Other Considerations for the Selection of 2012 Physician
Quality Reporting System Measures
(3) 2012 Physician Quality Reporting System Individual Measures
(A) 2012 Physician Quality Reporting System Core Measures
Available for Claims, Registry, and/or EHR-Based Reporting
(B) 2012 Physician Quality Reporting System Individual Measures
for Claims and Registry Reporting
(C) 2012 Measures Available for EHR-Based Reporting
(4) 2012 Physician Quality Reporting System Measures Groups
(5) 2012 Physician Quality Reporting System Quality Measures for
Group Practices Selected To Participate in the GPRO (GPRO)
g. Maintenance of Certification Program Incentive
h. Feedback Reports
i. Informal Review
j. Future Payment Adjustments for the Physician Quality
Reporting System
2. Incentives and Payment Adjustments for Electronic Prescribing
(eRx)--The Electronic Prescribing Incentive Program
a. Program Background and Statutory Authority
b. Eligibility
(1) Individual Eligible Professionals
(A) Definition of Eligible Professional
(2) Group Practices
(A) Definition of ``Group Practice''
(B) Process To Participate in the eRx Incentive Program--eRx
GPRO
c. Reporting Periods
(1) Reporting Periods for the 2012 and 2013 eRx Incentives
(2) Reporting Periods for the 2013 and 2014 eRx Payment
Adjustments
d. Standard for Determining Successful Electronic Prescribers
(1) Reporting the Electronic Prescribing Quality Measure
(2) The Denominator for the Electronic Prescribing Measure
(3) The Reporting Numerator for the Electronic Prescribing
Measure
e. Required Functionalities and Part D Electronic Prescribing
Standards
(1) ``Qualified'' Electronic Prescribing System
[[Page 73030]]
(2) Part D Electronic Prescribing Standards
f. Reporting Mechanisms for the 2012 and 2013 Reporting Periods
(1) Claims-Based Reporting
(2) Registry-Based Reporting
(3) EHR-Based Reporting
g. The 2012 and 2013 eRx Incentives
(1) Applicability of 2012 and 2013 eRx Incentives for Eligible
Professionals and Group Practices
(2) Reporting Criteria for Being a Successful Electronic for the
2012 and 2013 eRx Incentives--Individual Eligible Professionals
(3) Criteria for Being a Successful Electronic Prescriber 2012
and 2013 eRx Incentives--Group Practices
(4) No Double Payments
h. The 2013 and 2014 Electronic Prescribing Payment Adjustments
(1) Limitations to the 2013 and 2014 eRx Payment Adjustments--
Individual Eligible Professionals
(2) Requirements for the 2013 and 2014 eRx Payment Adjustments--
Individual Eligible Professionals
(3) Requirements for the 2013 and 2014 eRx Payment Adjustments--
Group Practices
(4) Significant Hardship Exemptions
(A) Significant Hardship Exemptions
(i) Inability To Electronically Prescribe Due to Local, State,
or Federal Law or Regulation
(ii) Eligible Professionals Who Prescribe Fewer Than 100
Prescriptions During a 6-Month, Payment Adjustment Reporting Period
(B) Process for Submitting Significant Hardship Exemptions--
Individual Eligible Professionals and Group Practices
G. Physician Compare Web site
1. Background and Statutory Authority
2. Final Plans
H. Medicare EHR Incentive Program for Eligible Professionals for
the 2012 Payment Year
1. Background
2. Attestation
3 The Physician Quality Reporting System--Medicare EHR Incentive
Pilot
a. EHR Data Submission Vendor-Based Reporting Option
b. Direct EHR-Based Reporting Option
4. Method for EPs To Indicate Election To Participate in the
Physician Quality Reporting System--Medicare EHR Incentive Pilot for
Payment Year 2012
I. Establishment of the Value-Based Payment Modifier and
Improvements to the Physician Feedback Program
1. Overview
2. The Value Based Modifier
a. Measures of Quality of Care and Costs
(1) Quality of Care Measures
(A) Quality of Care Measures for the Value-Modifier
(B) Potential Quality of Care Measures for Additional Dimensions
of Care in the Value Modifier
(i) Outcome Measures
(ii) Care Coordination/Transition Measures
(iii) Patient Safety, Patient Experience and Functional Status
(2) Cost Measures
(A) Cost Measures for the Value Modifier
(B) Potential Cost Measures for Future Use in the Value Modifier
b. Implementation of the Value Modifier
c. Initial Performance Period
d. Other Issues
3. Physician Feedback Program
a. Alignment of Physician Quality Reporting System Quality Care
Measures With the Physician Feedback Reports
b. 2010 Physician Group and Individual Reports Disseminated in
2011
J. Physician Self-Referral Prohibition: Annual Update to the
List of CPT/HCPCS Codes
1. General
2. Annual Update to the Code List
a. Background
b. Response to Comments
c. Revisions Effective for 2012
K. Technical Corrections
1. Outpatient Speech-Language Pathology Services: Conditions and
Exclusions
2. Outpatient Diabetes Self-Management Training and Diabetes
Outcome Measurements
a. Changes to the Definition of Deemed Entity
b. Changes to the Condition of Coverage Regarding Training
Orders
3. Practice Expense Relative Value Units (RVUs)
VII. Waiver of Proposed Rulemaking and Collection of Information
Requirements
A. Waiver of Proposed Rulemaking and Delay of Effective Date
B. Collection of Information Requirements
1. Part B Drug Payment
2. The Physician Quality Reporting System (Formerly the
Physician Quality Reporting Initiative (PQRI))
a. Estimated Participation in the 2010 Physician Quality
Reporting System
b. Burden Estimate on Participation in the 2010 Physician
Quality Reporting System--Individual Eligible Professionals
(1) Burden Estimate on Participation in the 2012 Physician
Quality Report System via the Claims-Based Reporting Mechanism--
Individual Eligible Professionals
(2) Burden Estimate on Participation in the 2012 Physician
Quality Reporting System--Group Practices
(3) Burden Estimate on Participation in the Maintenance of
Certification Program Incentive
(4) Burden Estimate on Participation in the Maintenance of
Certification Program Incentive
3. Electronic Prescribing (eRx) Incentive Program
a. Estimate on Participation in the 2012, 2013, and 2014 eRx
Incentive Program
b. Burden Estimate on Participation in the eRx Incentive
Program--Individual Eligible Professionals
(1) Burden Estimate on Participation in the eRx Incentive
Program via the Claims-Based Reporting Mechanism- Individual
Eligible Professionals
(2) Burden Estimate on Participation in the eRx Incentive
Program via the Registry-Based Reporting Mechanism- Individual
Eligible Professionals and Group Practices
(3) Burden Estimate on Participation in the eRx Incentive
Program via the EHR-Based Reporting Mechanism--Individual Eligible
Professionals and Group Practices
(4) Burden Estimate on Participation in the eRx Incentive
Program--Group Practices
4. Medicare Electronic Health Record (EHR) Incentive Program for
Eligible Professionals for the 2012 Payment Year
VIII. Response to Comments
IX. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. RVU Impacts
1. Resource-Based Work, PE, and Malpractice RVUs
2. CY 2012 PFS Impact Discussion
a. Changes in RVUs
b. Combined Impact
D. Effects of Proposal To Review Potentially Misvalued Codes on
an Annual Basis Under the PFS
E. Effect of Revisions to Malpractice RUVs
F. Effect of Changes to Geographic Practice Cost Indices (GPCIs)
G. Effects of Final Changes to Medicare Telehealth Services
Under the Physician Fee Schedule H Effects of the Impacts of Other
Provisions of the Final Rule With Comment Period
1. Part B Drug Payment: ASP Issues
2. Chiropractic Services Demonstration
3. Extension of Payment for Technical Component of Certain
Physician Pathology Services
4. Section 4103: Medicare Coverage of Annual Wellness Visit
Providing a Personalized Prevention Plan: Incorporation of a Health
Risk Assessment as Part of the Annual Wellness Visit
5. Physician Payment, Efficiency, and Quality Improvements--
Physician Quality Reporting System
6. Incentives for Electronic Prescribing (eRx)--The Electronic
Prescribing Incentive Program
7. Physician Compare Web site
8. Medicare EHR Incentive Program
9. Physician Feedback Program/Value Modifier Payment
10. Bundling of Payments for Services Provided to Outpatients
Who Later Are Admitted as Inpatients: 3-Day Window Policy and Impact
on Wholly Owned or Wholly Operated Physician Offices
11. Clinical Lab Fee Schedule: Signature on Requisition
I. Alternatives Considered
J. Impact on Beneficiaries
K. Accounting Statement
L. Conclusion
X. Addenda Referenced in This Rule and Available Only Through the
Internet on the CMS Web Site
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule with comment period, we are
listing these acronyms and their corresponding terms in alphabetical
order as follows:
[[Page 73031]]
AA Anesthesiologist assistant
AACE American Association of Clinical Endocrinologists
AACVPR American Association of Cardiovascular and Pulmonary
Rehabilitation
AADE American Association of Diabetes Educators
AANA American Association of Nurse Anesthetists
ABMS American Board of Medical Specialties
ABN Advanced Beneficiary Notice
ACC American College of Cardiology
ACGME Accreditation Council on Graduate Medical Education
ACLS Advanced cardiac life support
ACP American College of Physicians
ACR American College of Radiology
ACS American Community Survey
ADL Activities of daily living
AED Automated external defibrillator
AFROC Association of Freestanding Radiation Oncology Centers
AFS Ambulance Fee Schedule
AHA American Heart Association
AHFS-DI American Hospital Formulary Service-Drug Information
AHRQ [HHS] Agency for Healthcare Research and Quality
AMA American Medical Association
AMA RUC [AMA's Specialty Society] Relative (Value) Update Committee
AMA-DE American Medical Association Drug Evaluations
AMI Acute Myocardial Infarction
AMP Average Manufacturer Price
AO Accreditation organization
AOA American Osteopathic Association
APA American Psychological Association
APC Administrative Procedures Act
APTA American Physical Therapy Association
ARRA American Recovery and Reinvestment Act (Pub. L. 111-5)
ASC Ambulatory surgical center
ASP Average Sales Price
ASPE Assistant Secretary of Planning and Evaluation (ASPE)
ASRT American Society of Radiologic Technologists
ASTRO American Society for Therapeutic Radiology and Oncology
ATA American Telemedicine Association
AWP Average Wholesale Price
AWV Annual Wellness Visit
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)
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection
Act of 2000 (Pub. L. 106-554)
BLS Bureau of Labor and Statistics
BMD Bone Mineral Density
BMI Body Mass Index
BN Budget Neutrality
BPM Benefit Policy Manual
CABG Coronary Artery Bypass Graft
CAD Coronary Artery Disease
CAH Critical Access Hospital
CAHEA Committee on Allied Health Education and Accreditation
CAP Competitive Acquisition Program
CARE Continuity Assessment Record and Evaluation
CBIC Competitive Bidding Implementation Contractor
CBP Competitive Bidding Program
CBSA Core-Based Statistical Area
CDC Centers for Disease Control and Prevention
CEM Cardiac Event Monitoring
CF Conversion Factor
CFC Conditions for Coverage
CFR Code of Federal Regulations
CKD Chronic Kidney Disease
CLFS Clinical Laboratory Fee Schedule
CMA California Medical Association
CMD Contractor Medical Director
CME Continuing Medical Education
CMHC Community Mental Health Center
CMPs Civil Money Penalties
CMS Centers for Medicare & Medicaid Services
CNS Clinical Nurse Specialist
CoP Condition of Participation
COPD Chronic Obstructive Pulmonary Disease
CORF Comprehensive Outpatient Rehabilitation Facility
COS Cost of Service
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPI-U Consumer Price Index for Urban Consumers
CPR Cardiopulmonary Resuscitation
CPT [Physicians] Current Procedural Terminology (4th Edition, 2002,
copyrighted by the American Medical Association)
CQM Clinical Quality Measures
CR Cardiac Rehabilitation
CRF Chronic Renal Failure
CRNA Certified Registered Nurse Anesthetist
CROs Clinical Research Organizations
CRP Canalith Repositioning
CRT Certified Respiratory Therapist
CSC Computer Sciences Corporation
CSW Clinical Social Worker
CT Computed Tomography
CTA Computed Tomography Angiography
CWF Common Working File
CY Calendar Year
D.O. Doctor of Osteopathy
DEA Drug Enforcement Agency
DHHS Department of Health and Human Services
DHS Designated health services
DME Durable Medical Equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and
supplies
DOJ Department of Justice
DOQ Doctors Office Quality
DOS Date of service
DOTPA Development of Outpatient Therapy Alternatives
DRA Deficit Reduction Act of 2005 (Pub. L. 109-171)
DSMT Diabetes Self-Management Training Services
DXA CPT Dual energy X-ray absorptiometry
E/M Evaluation and Management Medicare Services
ECG Electrocardiogram
EDI Electronic data interchange
EEG Electroencephalogram
EGC Electrocardiogram
EHR Electronic health record
EKG Electrocardiogram
EMG Electromyogram
EMTALA Emergency Medical Treatment and Active Labor Act
EOG Electro-oculogram
EPO Erythopoeitin
EPs Eligible Professional
eRx Electronic Prescribing
ESO Endoscopy Supplies
ESRD End-Stage Renal Disease
FAA Federal Aviation Administration
FAX Facsimile
FDA Food and Drug Administration (HHS)
FFS Fee-for-service
FISH In Situ Hybridization Testing
FOTO Focus On Therapeutic Outcomes
FQHC Federally Qualified Health Center
FR Federal Register
FTE Full Time Equivalent
GAF Geographic Adjustment Factor
GAO Government Accountability Office
GEM Generating Medicare [Physician Quality Performance Measurement
Results]
GFR Glomerular Filtration Rate
GME Graduate Medical Education
GPCIs Geographic Practice Cost Indices
GPO Group Purchasing Organization
GPRO Group Practice Reporting Option
GPS Geographic Positioning System
GSA General Services Administration
GT Growth Target
HAC Hospital-Acquired Conditions
HBAI Health and Behavior Assessment and Intervention
HCC Hierarchal Condition Category
HCPAC Health Care Professionals Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HDL/LDL High-Density Lipoprotein/Low-Density Lipoprotein
HDRT High Dose Radiation Therapy
HEMS Helicopter Emergency Medical Services
HH PPS Home Health Prospective Payment System
HHA Home Health Agency
HHRG Home Health Resource Group
HHS [Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
(Pub. L. 104-191)
HIT Health Information Technology
HITECH Health Information Technology for Economic and Clinical
Health Act (Title IV of Division B of the Recovery Act, together
with Title XIII of Division A of the Recovery Act)
HITSP Healthcare Information Technology Standards Panel
HIV Human Immunodeficiency Virus
HMO Health Maintenance Organization
HOPD Hospital Outpatient Department
HPSA Health Professional Shortage Area
HRA Health Risk Assessment
HRSA Health Resources Services Administration (HHS)
HSIP HPSA Surgical Incentive Program
HUD Department of Housing and Urban Development
HUD Housing and Urban Development
IACS Individuals Access to CMS Systems
IADL Instrumental Activities of Daily Living
[[Page 73032]]
ICD International Classification of Diseases
ICF Intermediate Care Facilities
ICF International Classification of Functioning, Disability and
Health
ICR Intensive Cardiac Rehabilitation
ICR Information Collection Requirement
IDE Investigational Device Exemption
IDTF Independent Diagnostic Testing Facility
IFC Interim Rinal Rule with Comment Period
IGI IHS Global Insight, Inc.
IME Indirect Medical Education
IMRT Intensity-Modulated Radiation Therapy
INR International Normalized Ratio
IOM Institute of Medicine
IOM Internet Only Manual
IPCI Indirect Practice Cost Index
IPPE Initial Preventive Physical Examination
IPPS Inpatient Prospective Payment System
IRS Internal Revenue Service
ISO Insurance Services Office
IVD Ischemic Vascular Disease
IVIG Intravenous Immune Globulin
IWPUT Intra-service Work Per Unit of Time
JRCERT Joint Review Committee on Education in Radiologic Technology
KDE Kidney Disease Education
LCD Local Coverage Determination
LOPS Loss of Protective Sensation
LUGPA Large Urology Group Practice Association
M.D. Doctor of Medicine
MA Medicare Advantage Program
MAC Medicare Administrative Contractor
MA-PD Medicare Advantage-Prescription Drug Plans
MAV Measure Applicability Validation
MCMP Medicare Care Management Performance
MCP Monthly Capitation Payment
MDRD Modification of Diet in Renal Disease
MedCAC Medicare Evidence Development and Coverage Advisory Committee
(formerly the Medicare Coverage Advisory Committee (MCAC))
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MGMA Medical Group Management Association
MIEA-TRHCA Medicare Improvements and Extension Act of 2006 (that is,
Division B of the Tax Relief and Health Care Act of 2006 (TRHCA)
(Pub. L. 109-432)
MIPPA Medicare Improvements for Patients and Providers Act of 2008
(Pub. L. 110-275)
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Pub. L. 108-173)
MMEA Medicare and Medicaid Extenders Act of 2010 (Pub. L. 111-309)
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L.
110-173)
MNT Medical Nutrition Therapy
MOC Maintenance of Certification
MP Malpractice
MPC Multispecialty Points of Comparison
MPPR Multiple Procedure Payment Reduction Policy
MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539)
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MSA Metropolitan Statistical Area
MSP Medicare Secondary Payer
MUE Medically Unlikely Edit
NAICS North American Industry Classification System
NBRC National Board for Respiratory Care
NCCI National Correct Coding Initiative
NCD National Coverage Determination
NCQA National Committee for Quality Assurance
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NDC National Drug Codes
NF Nursing facility
NISTA National Institute of Standards and Technology Act
NP Nurse Practitioner
NPI National Provider Identifier
NPP Nonphysician Practitioner
NPPES National Plan & Provider Enumeration System
NQF National Quality Forum
NRC Nuclear Regulatory Commission
NSQIP National Surgical Quality Improvement Program
NTSB National Transportation Safety Board
NUBC National Uniform Billing Committee
OACT [CMS] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
OCR Optical Character Recognition
ODF Open Door Forum
OES Occupational Employment Statistics
OGPE Oxygen Generating Portable Equipment
OIG Office of the Inspector General
OMB Office of Management and Budget
ONC [HHS] Office of the National Coordinator for Health IT
OPPS Outpatient Prospective Payment System
OSCAR Online Survey and Certification and Reporting
PA Physician Assistant
PACE Program of All-inclusive Care for the Elderly
PACMBPRA Preservation of Access to Care for Medicare Beneficiaries
and Pension Relief Act of 2010 (Pub. L. 111-192)
PAT Performance Assessment Tool
PC Professional Components
PCI Percutaneous Coronary Intervention
PCIP Primary Care Incentive Payment Program
PDP Prescription Drug Plan
PE Practice Expense
PE/HR Practice Expense per Hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment Chain and Ownership System
PERC Practice Expense Review Committee
PFS Physician Fee Schedule
PGP [Medicare] Physician Group Practice
PHI Protected Health Information
PHP Partial Hospitalization Program
PIM [Medicare] Program Integrity Manual
PLI Professional Liability Insurance
POA Present On Admission
POC Plan Of Care
PODs Physician Owned Distributors
PPATRA Physician Payment And Therapy Relief Act
PPI Producer Price Index
PPIS Physician Practice Expense Information Survey
PPPS Personalized Prevention Plan Services
PPS Prospective Payment System
PPTA Plasma Protein Therapeutics Association
PQRI Physician Quality Reporting Initiative
PR Pulmonary rehabilitation
PRA Paperwork Reduction Act
PSA Physician Scarcity Areas
PT Physical Therapy
PTA Physical Therapy Assistant
PTCA Percutaneous Transluminal Coronary Angioplasty
PVBP Physician and Other Health Professional Value-Based Purchasing
Workgroup
QDCs (Physician Quality Reporting System) Quality Data Codes
RA Radiology Assistant
RAC Medicare Recovery Audit Contractor
RBMA Radiology Business Management Association
RFA Regulatory Flexibility Act
RHC Rural Health Clinic
RHQDAPU Reporting Hospital Quality Data Annual Payment Update
Program
RIA Regulatory Impact Analysis
RN Registered Nurse
RNAC Reasonable Net Acquisition Cost
RPA Radiology Practitioner Assistant
RRT Registered Respiratory Therapist
RUC [AMA's Specialty Society] Relative (Value) Update Committee
RVRBS Resource-Based Relative Value Scale
RVU Relative Value Unit
SBA Small Business Administration
SCHIP State Children's Health Insurance Programs
SDW Special Disability Workload
SGR Sustainable Growth Rate
SLP Speech-Language Pathology
SMS [AMAs] Socioeconomic Monitoring System
SNF Skilled Nursing Facility
SOR System of Record
SRS Stereotactic Radiosurgery
SSA Social Security Administration
SSI Social Security Income
STARS Services Tracking and Reporting System
STATS Short Term Alternatives for Therapy Services
STS Society for Thoracic Surgeons
TC Technical Components
TIN Tax Identification Number
TJC Joint Commission
TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432)
TTO Transtracheal Oxygen
UAF Update Adjustment Factor
UPMC University of Pittsburgh Medical Center
URAC Utilization Review Accreditation Committee
USDE United States Department of Education
USP-DI United States Pharmacopoeia-Drug Information
VA Department of Veterans Affairs
VBP Value-Based Purchasing
WAC Wholesale Acquisition Cost
WAMP Widely Available Market Price
WHO World Health Organization
[[Page 73033]]
Addenda Available Only Through the Internet on the CMS Web Site
In the past, the Addenda referred to throughout the preamble of our
annual PFS proposed and final rules with comment period were included
in the printed Federal Register. However, beginning with the CY 2012
PFS proposed rule, the PFS Addenda no longer appear in the Federal
Register. Instead these Addenda to the annual proposed and final rules
with comment period will be available only through the Internet. The
PFS Addenda along with other supporting documents and tables referenced
in this final rule with comment period are available through the
Internet on the CMS Web site at https://www.cms.gov/PhysicianFeeSched/.
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 2012 PFS final rule with
comment period, refer to item CMS-1524-FC. For complete details on the
availability of the Addenda referenced in this final rule with comment
period, we refer readers to section X. of this final rule with comment
period. Readers who experience any problems accessing any of the
Addenda or other documents referenced in this final rule with comment
period and posted on the CMS Web site identified above should contact
Rebecca Cole at (410) 786-1589 or Erin Smith at (410) 786-4497.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule with comment period, we use CPT codes
and descriptions to refer to a variety of services. We note that CPT
codes and descriptions are copyright 2010 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. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The Act requires that payments under the
physician fee schedule (PFS) are based on national uniform relative
value units (RVUs) based on the relative resources used in furnishing a
service. Section 1848(c) of the Act requires that national RVUs be
established for physician work, practice expense (PE), and malpractice
expense. Before the establishment of the resource-based relative value
system, Medicare payment for physicians' services was based on
reasonable charges. We note that throughout this final rule with
comment period, unless otherwise noted, the term ``practitioner'' is
used to describe both physicians and nonphysician practitioners (such
as physician assistants, nurse practitioners, clinical nurse
specialists, certified nurse-midwives, psychologists, or clinical
social workers) that are permitted to furnish and bill Medicare under
the PFS for their services.
A. Development of the Relative Value System
1. Work RVUs
The concepts and methodology underlying the PFS were enacted as
part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L.
101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published
on November 25, 1991 (56 FR 59502), set forth the fee schedule for
payment for physicians' services beginning January 1, 1992. Initially,
only the physician work RVUs were resource-based, and the PE and
malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the
fee schedule in January 1992 was developed with extensive input from
the physician community. A research team at the Harvard School of
Public Health developed the original physician work RVUs for most codes
in a cooperative agreement with the Department of Health and Human
Services (DHHS). In constructing the code-specific vignettes for 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.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for
anesthesia services are based on RVUs from a uniform relative value
guide, with appropriate adjustment of the conversion factor (CF), in a
manner to assure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value. We
established a separate CF for anesthesia services, and we continue to
utilize time units as a factor in determining payment for these
services. As a result, there is a separate payment methodology for
anesthesia services.
We establish physician work RVUs for new and revised codes based,
in part, on our review of recommendations received from the American
Medical Association's (AMA's) Specialty Society Relative Value Update
Committee (RUC).
2. Practice Expense Relative Value Units (PE RVUs)
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 to
consider general categories of expenses (such as office rent and wages
of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.
105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay
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 charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physician's
service in a final rule with comment period, published November 2, 1998
(63 FR 58814), effective for services furnished in 1999. Based on the
requirement to transition to a resource-based system for PE over a 4-
year period, resource-based PE RVUs did not become fully effective
until 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. The CPEP data were
collected from panels of physicians, practice administrators, and
nonphysician health professionals (for example, registered nurses
(RNs)) nominated by physician specialty societies and other groups. The
CPEP panels identified the direct inputs required for each physician's
service in both the office setting and out-of-office setting. We have
since refined and revised these inputs based on recommendations from
the AMA RUC. The AMA's SMS data provided aggregate specialty-specific
information on hours worked and PEs.
Separate PE RVUs are established for procedures that can be
performed in both a nonfacility setting, such as a physician's office,
and a facility setting, such as a hospital outpatient department
(HOPD). The difference between the facility and nonfacility RVUs
reflects the fact that a facility typically receives separate payment
from Medicare for its costs of providing the service, apart from
payment under the PFS. The nonfacility RVUs reflect all
[[Page 73034]]
of the direct and indirect PEs of providing a particular service.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113) 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 with
comment period 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 calendar year (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 and provided for a 4-year transition for the new PE RVUs under
this new methodology. This transition ended in CY 2010 and direct PE
RVUs are calculated in CY 2012 using this methodology, unless otherwise
noted.
In the CY 2010 PFS final rule with comment period (74 FR 61749), we
updated the PE/hour (PE/HR) data that are used in the calculation of PE
RVUs for most specialties. For this update, we used the Physician
Practice Information Survey (PPIS) conducted by the AMA. The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and nonphysician practitioners (NPPs) using a survey instrument and
methods highly consistent with those of the SMS and the supplemental
surveys used prior to CY 2010. We note that in CY 2010, for oncology,
clinical laboratories, and independent diagnostic testing facilities
(IDTFs), we continued to use the supplemental survey data to determine
practice expense per hour (PE/HR) values (74 FR 61752). Beginning in CY
2010, we provided for a 4-year transition for the new PE RVUs using the
updated PE/HR data. In CY 2012, the third year of the transition, PE
RVUs are calculated based on a 75/25 blend of the new PE RVUs developed
using the PPIS data and the previous PE RVUs based on the SMS and
supplemental survey data.
3. Resource-Based Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based malpractice RVUs for services
furnished on or after CY 2000. The resource-based malpractice RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice
insurance premium data collected from commercial and physician-owned
insurers from all the States, the District of Columbia, and Puerto
Rico. In the CY 2010 PFS final rule with comment period (74 FR 61758),
we implemented the Second Five-Year Review and update of the
malpractice RVUs. In the CY 2011 PFS final rule with comment period, we
described our approach for determining malpractice RVUs for new or
revised codes that become effective before the next Five-Year Review
and update (75 FR 73208). Accordingly, to develop the CY 2012
malpractice RVUs for new or revised codes we crosswalked the new or
revised code to the malpractice RVUs of a similar source code and
adjusted for differences in work (or, if greater, the clinical labor
portion of the fully implemented PE RVUs) between the source code and
the new or revised code.
4. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review all
RVUs no less often than every 5-years. The First Five-Year Review of
Work RVUs was published on November 22, 1996 (61 FR 59489) and was
effective in 1997. The Second Five-Year Review of Work RVUs was
published in the CY 2002 PFS final rule with comment period (66 FR
55246) and was effective in 2002. The Third Five-Year Review of Work
RVUs was published in the CY 2007 PFS final rule with comment period
(71 FR 69624) and was effective on January 1, 2007. The Fourth Five-
Year Review of Work RVUs was initiated in the CY 2010 PFS final rule
with comment period where we solicited candidate codes from the public
for this review (74 FR 61941). Proposed revisions to work RVUs and
corresponding changes to PE and malpractice RVUs affecting payment for
physicians' services for the Fourth Five-Year Review of Work RVUs were
published in a separate Federal Register notice on June 6, 2011 (76 FR
32410). We have reviewed public comments, made adjustments to our
proposals in response to comments, as appropriate, and included final
values in this final rule with comment period, effective for services
furnished beginning January 1, 2012.
In 1999, the AMA RUC established the Practice Expense Advisory
Committee (PEAC) for the purpose of refining the direct PE inputs.
Through March 2004, the PEAC provided recommendations to CMS for over
7,600 codes (all but a few hundred of the codes currently listed in the
AMA's Current Procedural Terminology (CPT) codes). As part of the CY
2007 PFS final rule with comment period (71 FR 69624), we implemented a
new bottom-up methodology for determining resource-based PE RVUs and
transitioned the new methodology over a 4-year period. A comprehensive
review of PE was undertaken prior to the 4-year transition period for
the new PE methodology from the top-down to the bottom-up methodology,
and this transition was completed in CY 2010. In CY 2010, we also
incorporated the new PPIS data to update the specialty-specific PE/HR
data used to develop PE RVUs, adopting a 4-year transition to PE RVUs
developed using the PPIS data.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we
implemented the First Five-Year Review of the malpractice RVUs (69 FR
66263). Minor modifications to the methodology were addressed in the CY
2006 PFS final rule with comment period (70 FR 70153). The Second Five-
Year Review and update of resource-based malpractice RVUs was published
in the CY 2010 PFS final rule with comment period (74 FR 61758) and was
effective in CY 2010.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS
and the AMA 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 section 3134 of the Affordable Care
Act, which requires the agency to periodically identify, review and
adjust values for potentially misvalued codes with an emphasis on the
following categories: (1) Codes and families of codes for which there
has been the fastest growth; (2) codes or families of c
