[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Rules and Regulations]
[Pages 73026-73474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28597]
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Vol. 76
Monday,
No. 228
November 28, 2011
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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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
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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
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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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 http://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:
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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 (http://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)
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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)
(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
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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
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 http://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 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
[[Page 73035]]
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.
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 x GPCI work) + (RVU PE x GPCI PE) + (RVU
Malpractice x GPCI Malpractice)] x 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 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 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
[[Page 73036]]
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 Medicare-recognized specialty data.
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 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 http://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 http://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.
[[Page 73037]]
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.
(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 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 specialty-specific 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 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
[[Page 73038]]
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 PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the current aggregate pool of PE RVUs by the average
indirect PE percentage from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the 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
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service.
(Note: For services with TCs and PCs, we calculate the indirect
practice cost index across the global 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.
BILLING CODE 4120-01-P
[[Page 73039]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.000
BILLING CODE 4120-01-C
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services, but do not use TC and 26 modifiers (for
example, electrocardiograms). This flag associates the PC and TC with
the associated global code for use in creating the indirect PE RVUs.
For example, the professional service, CPT code 93010
(Electrocardiogram, routine ECG with at least 12 leads; interpretation
and report only), is associated with the global service, CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file. 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.
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
[[Page 73040]]
CY 2011 PFS final rule with comment 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.
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
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 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 http://www.cms.gov/PhysicianFeeSched/.
a. Inverted Equipment Minutes
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 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.
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 http://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 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 the supporting data files for the CY 2012 PFS final
rule with comment period at http://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
[[Page 73044]]
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 includes: an angiocatheter 14g-24g, bandage, strip 0.75in x 3in,
catheter, suction, dressing, 4in x 4.75in (Tegaderm), electrode, ECG
(single), electrode, ground, gas, oxygen, gauze, sterile 4in x 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 x 18in.
Equipment Inputs: ``Table, instrument, mobile'' (EF027),
``ECG, 3-channel (with SpO2, NIBP, temp, resp)'' (EQ011), ``IV infusion
pump'' (EQ032), ``pulse oxymetry recording software (prolonged
monitoring)'' (EQ212), and ``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, 3-channel (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
direct PE inputs with the stated refinements. One commenter suggested
that a particular code on the list should be removed since moderate
sedation is not typically performed when that service is furnished.
Response: We appreciate the support for our proposal to accept the
[[Page 73049]]
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 http://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 http://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 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 http://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 (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 G-codes 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
[[Page 73050]]
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 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.
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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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.
[[Page 73051]]
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 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. 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 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 post-service
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 post-time for CY 2012.
96153 (Health and behavior intervention, each 15 minutes,
face-to-face; 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 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 self-management training
services, group session (2 or more), per 30 minutes)
[[Page 73052]]
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
post-service 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 http://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 on the CMS Web site under the supporting data files for the
CY 2012 PFS proposed rule at http://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 pre-operative 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 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.
[[Page 73053]]
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.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes which have not been subject to review since the
implementation of the RBRVS (the so-called `Harvard-valued codes').
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 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 Five-Year 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 site-of-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
[[Page 73054]]
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: site-of-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 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 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
[[Page 73055]]
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 system-wide
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
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' Five-Year 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 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
[[Page 73056]]
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, 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.
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.
[[Page 73057]]
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 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 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
[[Page 73058]]
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 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 intra-specialty.
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 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
[[Page 73059]]
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 Medicare-aged 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 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 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 http://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
[[Page 73060]]
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 multi-specialty 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 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 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 patient-centered 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 non-primary 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
[[Page 73061]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.008
[[Page 73062]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.009
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 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 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
[[Page 73063]]
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 patient-
centered 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 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 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.
[[Page 73064]]
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 http://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 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 http://innovations.cms.gov/areas-of-focus/seamless-and-coordinated-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 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 patient-centered 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
[[Page 73065]]
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 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 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
[[Page 73066]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.010
[[Page 73067]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.011
BILLING CODE 4120-01-C
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. 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
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
[[Page 73068]]
specified time period. Also, regarding the suggestion to schedule
review of high expenditure codes every 10 to 15-years, 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.
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 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 RUC- recommended 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
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.
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 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.
[[Page 73069]]
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.
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: http://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 billed using CPT Codes 88365 (In situ hybridization (e.g.,
FISH), each probe), 88367 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative) each probe; using computer-assisted
technology) and 88368 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative) 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
[[Page 73070]]
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 semi-quantitative) each probe; using computer-assisted
technology); and 88368 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative) 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.
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
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
[[Page 73071]]
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 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 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
[[Page 73072]]
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 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 (non-continguous 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
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
[[Page 73073]]
disciplines, including, physical therapy, occupational therapy, or
speech-language 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, 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 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 post-service
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
[[Page 73074]]
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 post-
service 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- post- and 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, 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.
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 re-review prior images,
commenters stated
[[Page 73075]]
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 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 follow-up discussions
with patients, staff and physicians. In contrast to the analysis
published by the ACR, we found--
Significant duplication in the pre-service 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 post-service work, which
almost always consists of reviewing and signing a final report and
discussing findings with the referring physician; and
Moderate efficiencies in intra-service 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.
BILLING CODE 4120-01-P
[[Page 73076]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.012
BILLING CODE 4120-01-C
[[Page 73077]]
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, 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 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
[[Page 73078]]
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 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 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
[[Page 73079]]
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 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 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, community-based 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 self-referral 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
[[Page 73080]]
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.
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-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 pre- and 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.
[[Page 73081]]
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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
resource-based 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 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 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
[[Page 73082]]
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. 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: http://www.iom.edu/Reports/2011/Geographic-Adjustment-in-Medicare-Payment-Phase-I-Improving-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-for-service 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
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.
[[Page 73083]]
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 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.
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 labor-related 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.
[[Page 73084]]
(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.
(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 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 industry-
specific information describing the number of hours worked in each
occupation (see: http://www.bls.gov/oes/current/naics4_621100.htm).
Our 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: http://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 non-physician 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 labor-related 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 labor-related 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.
[[Page 73085]]
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 labor-related 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 http://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: http://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 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 2006-based MEI. The MEI
was rebased and revised in the CY 2011 final rule with comment period
to reflect the weighted-average 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 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
[[Page 73086]]
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 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 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 (http://www.cms.gov/PhysicianFeeSched/). In addition, information regarding the CY 2011
update to the MEI can be reviewed beginning on 75 FR 73262.
[GRAPHIC] [TIFF OMITTED] TR28NO11.014
(F) PE GPCI Floor for Frontier States
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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.015
[[Page 73087]]
(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
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.
Employee Compensation
Comment: Most commenters agreed with CMS' proposal to expand the
occupations used to calculate the non-physician 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 http://www.iom.edu/Reports/2011/Geographic-Adjustment-in-Medicare-Payment-Phase-I-Improving-Accuracy.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
[[Page 73088]]
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 http://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 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 http://www.cms.gov/PhysicianFeeSched/downloads/GPCI_Report.pdf. In addition,
the IOM in their report titled ``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 self-reporting 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
[[Page 73089]]
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
non-professional 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 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
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
[[Page 73090]]
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.
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: http://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.
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 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 non-physician 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
[[Page 73091]]
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 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 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
http://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: http://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
[[Page 73092]]
address any changes to Medicare PFS localities in future rulemaking.
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 http://www.iom.edu/Reports/2011/Geographic-Adjustment-in-Medicare-Payment-Phase-I-Improving-Accuracy.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 high-value, high-quality health care.
The recommendations included in IOM's revised Phase I report that
relate 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-for-service 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 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 face-to-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
[[Page 73093]]
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 Sec. 410.78(b), we generally
require that a telehealth service be furnished via an interactive
telecommunications system. Under Sec. 410.78(a)(3), an interactive
telecommunications system is defined as multimedia communications
equipment that includes, at a minimum, audio and video equipment
permitting two-way, real time interactive communication between the
patient and 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 Sec. 410.78(a)(1), store and forward means the asynchronous
transmission of medical information from an originating site to be
reviewed at a later time by the practitioner at the distant site.
Medicare telehealth services may be 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 hospital-based renal dialysis centers, skilled nursing
facilities (SNFs), and community mental health centers (CMHCs). In
order to serve as a 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 self-management training
services (DSMT).
In general, the practitioner at the distant site may be any of the
following, provided that the practitioner is 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
[[Page 73094]]
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 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 in-person 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, we refer
readers to the CMS Web site at http://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; re-
assessment 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
[[Page 73095]]
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 Sec. 410.78(b) and Sec. 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
Sec. 410.78(b) and Sec. 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; 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, 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-to-face 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
[[Page 73096]]
``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 in-person
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 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 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
[[Page 73097]]
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 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 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
[[Page 73098]]
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 in-person services, speed
of access to in-person 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 made using evidence-based, peer-reviewed 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 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 information-submission 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
[[Page 73099]]
example, as compared with the in-person 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 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 in-person
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. 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 in-person.
[[Page 73100]]
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 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 in-person 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 in-person service is misleading to patients
and would prevent Medicare beneficiaries from getting the actual in-
person 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
[[Page 73101]]
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-to-face services, and that CMS will consider
clinical benefits on a case-by-case 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
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
self-fulfilling and might prevent the addition of otherwise appropriate
services to the list of Medicare telehealth services since the codes
were written to describe in-person 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 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 in-
person critical care services requested for addition to the telehealth
list.
After consideration of the public comments we received, we are
[[Page 73102]]
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.
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 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 G-codes 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.016
[[Page 73103]]
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 G-codes we created
for telehealth consultations are used exclusively under the telehealth
benefit. In this unique circumstance, we believe that 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 G-codes 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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.017
[[Page 73104]]
6. Telehealth Originating Site Facility Fee Payment Amount Update
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
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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.018
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-of-service 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
[[Page 73105]]
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 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 post-procedure 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 cross-specialty 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
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.
[cir] 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
[[Page 73106]]
III.B.1.b. of this final rule with comment period.
[cir] 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-of-service 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
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-of-service 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-of-service 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 post-procedure
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 23-hours or less, we believe it is generally appropriate to include
the intra-service time of the inpatient hospital visit in the immediate
post-service time of the 23-hour 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 Five-Year 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 Five-Year 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 site-of-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
post-operative period, we removed any post-procedure 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 RUC-recommended 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.
[[Page 73107]]
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 23-hour 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 23-hour 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 risk-benefit 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 the
23-hour stay category should not reflect physician work that is
typically associated with an inpatient service.
[cir] 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 RUC-recommended time. Similarly, we also adjusted the
post-service time to two-thirds 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 multi-specialty
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 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
[[Page 73108]]
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 RUC-recommended
RVUs. Furthermore, in the past, we have asked commenters 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;
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 multi-specialty 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
[[Page 73109]]
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 pre-service 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 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 multi-
specialty 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 RUC-
recommended 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 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 pre- and
post-service time (add-on codes generally do not have pre- and post-
service 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 RUC-
recommended work RVU of 0.69 is more appropriate for this service.
Commenters noted that removing the RVUs related to the pre- and post-
service 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
RUC-recommended 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
[[Page 73110]]
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 RUC-
recommended work RVU of 3.00 is more appropriate for this service.
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 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-
recommended work RVU of 1.29 is more appropriate for this service.
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 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 RUC-
recommended work RVU of 4.56 is more appropriate for this service.
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 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.
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 RUC-
recommended work RVU of 2.00 is more appropriate for this service.
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 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
[[Page 73111]]
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 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 HCPAC-recommended 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.019
As mentioned previously, and detailed in the CY 2011 PFS final rule
with comment period, for CPT code 97598, we disagreed with the HCPAC-
recommended 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 multi-specialty 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.
(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 HCPAC-recommended 3 minutes
of post-service time was excessive for this service (76 FR 32459).
[[Page 73112]]
Comment: Commenters disagreed with the proposed work RVU of 0.44
assigned to CPT code 11732 by CMS and believe that the HCPAC-
recommended 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 post- service
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
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 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 (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 intra-service
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 HCPAC- recommended 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 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 intra-service
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 Harvard-
Valued--Utilization > 30,000 screen. CPT codes 12032-12047, 12052-
12057, and 13100 were added as part of the
[[Page 73113]]
family of services for review. Also for the Fourth Five-Year Review, we
identified CPT code 15732 as potentially misvalued through the site-of-
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, 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 RUC-recommended 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 RUC-recommended 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 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 RUC-recommended 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 pre-evaluation 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 CMS-proposed 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
[[Page 73114]]
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 RUC-recommended 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 RUC-
recommended 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 RUC-recommended times for CPT code 13100 and 13101. Commenters note
that the current (CY 2011) Harvard times are very similar to the AMA
RUC-recommended times.
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 (Split-thickness 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 RUC-recommended
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 Five-Year Review physician time file available on the
CMS Web site at: http://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, 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 site-of-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-of-service 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
[[Page 73115]]
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
Harvard-Valued--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 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 intra-service times accurately reflected the
time required to conduct the intra-service 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 intra-service 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 intra-service times to the AMA RUC-recommended 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
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 RUC-recommended 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 site-of-service anomaly screen. CMS
also requested that the AMA RUC review other CPT codes in the family
including
[[Page 73116]]
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 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 re-reviewed 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 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
RUC-recommended 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
[[Page 73117]]
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 post-service 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 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 pre-service 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
post-service 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 pre-service evaluation
time, 1 minute pre-service 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 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
RUC-recommended 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
pre-service 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.
[[Page 73118]]
(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 post-service 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 RUC-recommended work
RVU and physician time.
Response: Based on the public comments received, we referred CPT
code 27385 to the CY 2011 multi-specialty refinement panel for further
review. The refinement panel median work RVU was 7.77 for CPT code
27385. 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 site-of-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 pre-service 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 one-third. We believed that 5
minutes pre-service 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 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 RUC-recommended work RVU and physician time.
Response: Based on the public comments received, we referred CPT
code 27530 to the CY 2011 multi-specialty 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 RUC-recommended 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
[[Page 73119]]
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. 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 the methodology described
previously to address 23-hour stay site-of-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 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 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
site-of-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 re-examine 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 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 RUC-recommended 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
[[Page 73120]]
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 RUC-recommended 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 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. After consideration of the 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 pre-service 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, 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 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. 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 pre-service 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
[[Page 73121]]
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 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 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 are believe
it is appropriate to apply our methodology described previously to
address 23-hour stay site-of-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 pre-service 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-of-service anomaly codes could be ``23-hour
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 recognize the CPT consultation codes (74 FR 61775).
The AMA RUC re-reviewed 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 RUC-recommended 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 post-operatively does not mean that the
post-operative 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
RUC-recommended 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
[[Page 73122]]
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 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 site-of-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 RUC-recommended work RVU and physician time.
Response: Based on comments received, we referred CPT code 28820 to
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 site-of-service anomalies. After
consideration of the public comments, refinement panel results, and our
clinical review, we are assigning a work RVU of 5.82 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 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 pre-service 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
[[Page 73123]]
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 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. 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 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 post-service 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 post-service 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 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 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-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 pre- and 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 post-service 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 post-service
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
pre-service 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
[[Page 73124]]
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 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 post-service time from 5 minutes to 3
minutes. In sum, for CPT code 29515 for CY 2012, we are finalizing the
Five-Year Review proposed and AMA RUC-recommended 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 HCPAC-recommended 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 HCPAC-recommended 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, 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 intra-
service, and 1 minute immediate post-service 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 post-service time, as we believed the HCPAC-recommended 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 HCPAC-recommended work
RVU of 0.25 and 7 minutes pre-service time, 5 minutes intra-service
time and 1 minute post-service 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 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
[[Page 73125]]
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 multi-specialty 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 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 multi-specialty 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 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 RUC-recommended 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
[[Page 73126]]
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 RUC-recommended 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 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 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 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 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
[[Page 73127]]
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.
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 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 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 RUC-recommended 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 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 RUC-
recommended 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
[[Page 73128]]
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 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 37.50, which are the
survey 25th percentile work RVUs, and more 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 RUC-
recommended 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 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 compared CPT code 33875 with CPT code 33465 and believed
that CPT code 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
[[Page 73129]]
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 RUC-recommended 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 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 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 RUC-
recommended global period change from 090 to XXX. However, we disagreed
with the AMA RUC-recommended 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 post-
operative 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 one-six 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 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 RUC-recommended 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
[[Page 73130]]
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 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 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 RUC-recommended
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 RVUs =
23.23), which have similar work intensities. Commenters requested that
CMS accept the AMA RUC-recommended 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 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 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 RUC-recommended 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 intra-service 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 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 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 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.
[[Page 73131]]
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 intra-service time), and CPT
code 37617 (Ligation, major artery (e.g., post-traumatic, 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 RUC-recommended 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 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 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 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 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 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 (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
pre-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 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 pre-service work and the
recommended pre-service 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 pre-service evaluation time of 3 minutes. In
addition, we are finalizing an intra-service time of 10 minutes, and a
post-service 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 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). The AMA RUC recommended the survey median work RVU of
7.00 for this service. We disagreed with the RUC-recommended 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
[[Page 73132]]
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-of- service anomaly. Medicare PFS claims data indicated
that this code is typically furnished 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.
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 site-of-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 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 final 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 Five-Year Review of Work (76 FR 32445
and 32446) where we noted this code was identified as a code with a
site-of-service anomaly. Medicare PFS claims data indicated that this
code is typically furnished 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. 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.
[[Page 73133]]
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 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 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 RUC-
recommended 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 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 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. 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.
[[Page 73134]]
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 multi-specialty 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 RUC-recommendation 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 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 pre-service 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
RUC-recommended physician times for CPT code 43262. The AMA RUC
requested that CMS accept the AMA RUC-recommended times be utilized for
CY 2012.
Response: We appreciate the AMA RUC accepting family of ERCP codes
for review in 2012. We continue to have concerns about the recommended
intra-service 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
Five-Year 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 RUC-
recommended 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 RUC-recommended 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).
[[Page 73135]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.020
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 pre-
budget 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 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 RUC-
recommended 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 RUC-recommended 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 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
[[Page 73136]]
results, and our clinical review, we are finalizing the CY 2011 interim
final work RVU values for paraesophageal 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:
[GRAPHIC] [TIFF OMITTED] TR28NO11.021
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).
(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 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 pre-service work and the
recommended pre-service 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.
(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 (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 post-procedure 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 RUC-recommended work RVU of 12.11 for CPT code
47563. Commenters disagreed with CMS' methodology to address 23-hour
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 intra-service time
than the key reference code 47562 (Laparoscopy, surgical;
cholecystectomy), and cautioned against a rank order anomaly within the
family
[[Page 73137]]
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 RUC-recommendation 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
site-of-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 RUC-recommended 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 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 RUC-recommended 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-of- service
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 site-of- 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, 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 multi-specialty 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 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. 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
[[Page 73138]]
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-of-services 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 site-of-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 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 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. 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 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 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 RUC-
recommended 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 pre-positioning time of 5 minutes for CPT
[[Page 73139]]
code 51705, which has an identical pre-positioning 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 RUC-recommended 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 pre-service work and the
recommended pre-service 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 pre-positioning time
of 5 minutes for CPT code 51705, which has an identical pre-positioning
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 pre-evaluation; 5 minutes for pre-service
positioning, 15 minutes for intra-service; 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 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
RUC-recommended 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 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 multi-specialty 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 site-of-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
[[Page 73140]]
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 RUC-
recommendation 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, wait) time of 15 minutes, an intra-service time of 60
minutes, and a post-service 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 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 site-of-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 intra-service time of 120 minutes, and a post-service 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,
[[Page 73141]]
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 RUC-recommendation 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 intra-service time of 90 minutes, and a
post-service 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).
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 RUC-recommended
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 Five-Year 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. 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
[[Page 73142]]
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).
(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 RUC-recommended 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.022
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).
[[Page 73143]]
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 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 RUC-recommended 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
code 99214, accurately reflects the work associated with the provision
of the post-partum office visit, and are maintaining the CMS-adjusted
pre-budget 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:
[GRAPHIC] [TIFF OMITTED] TR28NO11.023
(22) Endocrine System: Thyroid Gland (CPT Codes 60220-60240)
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 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
[[Page 73144]]
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 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.
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 pre-service time of 40
minutes, a pre-service positioning time of 12 minutes, a pre-service
(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 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 RUC-recommended 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 RUC-recommendation 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 site-of-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 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 pre-service time of 40 minutes, a pre-
service positioning time of 12 minutes, a pre-service (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
[[Page 73145]]
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 RUC-
recommendation 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 site-of-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 pre-service time of 40
minutes, a pre-service positioning time of 12 minutes, a pre-service
(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 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 RUC-recommended 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 RUC-recommended 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 RUC-
recommended work RVU for CPT code 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
[[Page 73146]]
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 site-of-
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 multi-specialty 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 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-of-service
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 site-of-service,
we believed that the survey median work RVU of 5.00 appropriately
accounted for the removal of the 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
[[Page 73147]]
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 RUC-recommended value adequately accounted for the shift from
inpatient to outpatient and the reduction in office/outpatient visits.
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
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-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 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 RUC-recommended
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 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
[[Page 73148]]
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 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 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 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 site-of-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 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.
[[Page 73149]]
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 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 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 RUC-
recommended 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,
[[Page 73150]]
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 site-of-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-
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 RUC-recommended
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 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 Five-Year 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-of-service 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 RUC-recommended 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 23-hour 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
[[Page 73151]]
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 RUC-
recommended 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 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 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
site-of-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).
(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 specialty-recommended
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.
(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
[[Page 73152]]
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 potentially misvalued
codes by the Five-Year 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 multi-specialty 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, 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 RUC-recommended
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 multi-specialty 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).
[[Page 73153]]
(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 RUC-recommended 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
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
RUC-recommended 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 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
[[Page 73154]]
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
RUC-recommended 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).
(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 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 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 2-dimensional 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 RUC-recommended work RVUs for the add-on 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, CMS-adjusted
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.
[[Page 73155]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.024
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 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 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).
(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 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 speech-language 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
[[Page 73156]]
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 HCPAC-
recommended 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 HCPAC-recommended 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: pre-service 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-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 pre-service work and the recommended pre-service 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.
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 one-third. We believed that 1 minute pre-service
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
[[Page 73157]]
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.
(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 RUC-recommended 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 pre-service time but a
lower AMA RUC-recommended 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).
(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 Harvard-
Valued--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
Five-Year 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 post-
service 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 pre-service 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 post-service
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 RUC-recommended work RVU of 0.50. For CPT code 98925, we removed a
total of 2 minutes from the AMA RUC-recommended 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 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
Five-Year 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 post-
service 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 pre-service 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
post-service 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 RUC-recommended work RVU of 0.75. For CPT code 98926, we removed a
total of 2 minutes from the AMA RUC-recommended 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
Five-Year 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 post-
service times of the osteopathic manipulative treatment code and the E/
M visit overlapped and should not be counted in developing the work
RVUs
[[Page 73158]]
for this service. As described earlier in section III.A. of this final
rule with comment period, we reduced the pre-service 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 post-service
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 RUC-recommended work RVU of 1.00. For CPT code 98927, we removed a
total of 2 minutes from the AMA RUC-recommended 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
Five-Year 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 post-
service 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 pre-service 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
post-service 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 RUC-recommended work RVU of 1.25. For CPT code 98928, we removed a
total of 2 minutes from the AMA RUC-recommended 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 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
Five-Year 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 post-
service 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 pre-service 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 post-service
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 RUC-recommended work RVU of 1.50. For CPT code 98929, we removed a
total of 2 minutes from the AMA RUC-recommended 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 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
post-service 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.
[[Page 73159]]
(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 Harvard-
Valued--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 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 RUC-recommended 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 multi-specialty 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 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 RUC-recommended 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 multi-specialty 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
[[Page 73160]]
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 RUC-recommended RVUs for 99218, 99219, and 99220, respectively.
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 RUC-recommended 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.
Response: Based on the comments we received, we referred CPT codes
99224, 99225, and 99226 to the CY 2011 multi-specialty 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.
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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: http://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 RUC-
recommended 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
(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
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 equipment rooms for
greeting/gowning, obtaining vital signs or providing pre-service
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 pre-service 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 intra-service
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
[[Page 73183]]
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 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 [email protected]. Requests
received by the end of a calendar year will be considered in rulemaking
during the following year. 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 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 RUC-recommended 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 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
[[Page 73185]]
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 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 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 non-specific kits can be
used when
[[Page 73186]]
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 sinus-surgery 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 rule (75 FR 73362). We
did not incorporate the CD as a supply item for 49418 since the code
also included x-ray 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 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 contractor-priced 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
[[Page 73187]]
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 RUC-
recommended 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: http://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 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 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
[[Page 73188]]
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.
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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.046
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,
[[Page 73189]]
as well as the proposed revisions to the malpractice risk factors for
the cardiothoracic surgery services described previously.
4. Payment for Bone Density Tests
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 x-
ray 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)); 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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.047
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.
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
For all other new, revised, or potentially misvalued codes with CY
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/.
C. Establishing Interim Final RVUs for CY 2012
1. Establishing Interim Final Work 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 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
[[Page 73190]]
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 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).
(1) Integumentary System: Skin, Subcutaneous, and Accessory Structures
(CPT Codes 10060-10061, and 11056)
[GRAPHIC] [TIFF OMITTED] TR28NO11.048
CPT code 10061 was identified by the AMA RUC Relativity Assessment
Workgroup through the Harvard-Valued--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 HCPAC-recommended 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(2) Integumentary System: Nails (CPT codes 11719-11721)
[GRAPHIC] [TIFF OMITTED] TR28NO11.049
[[Page 73191]]
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 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.
(3) Integumentary System: Repair (Closure) (CPT Codes 15271-15278,
15777, 16020, 16025)
[GRAPHIC] [TIFF OMITTED] TR28NO11.050
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 add-on 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 intra-service time, and an IWPUT of 0.0333. CPT
code 15272 has 10 minutes of intra-service time. Ten minutes of intra-
service work at the same intensity as CPT code 15341 is equal to a work
RVU of 0.33 (10 minutes x 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
[[Page 73192]]
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 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(4) Musculoskeletal: Hand and Fingers (CPT Code 26341)
[GRAPHIC] [TIFF OMITTED] TR28NO11.051
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
post-service 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.
(5) Musculoskeletal: Application of Casts and Strapping (CPT Codes
29581-29584)
[GRAPHIC] [TIFF OMITTED] TR28NO11.052
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
[[Page 73193]]
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 multi-layer 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 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 HCPAC-reviewed 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 intra-service 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.
(6) Musculoskeletal: Endoscopy/Arthroscopy (CPT Codes 29826, 29880,
29881)
[GRAPHIC] [TIFF OMITTED] TR28NO11.053
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
coraco-acromial 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
RUC-recommended 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(7) Respiratory: Lungs and Pleura (CPT Codes 32096-32854)
[[Page 73194]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.054
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 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 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
[[Page 73195]]
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 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 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 non-bullous) 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(8) Cardiovascular: Heart and Pericardium
[[Page 73196]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.055
(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.
(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 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 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
[[Page 73197]]
with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim
final the work RVUs listed in Table 19.
(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 intra-service,
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
intra-service 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 post-operative
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.,
post-traumatic, 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(9) Hemic and Lymphatic Systems: General, Bone Marrow or Stem Cell
Services/Procedures (CPT Codes 38230 and 38232)
[GRAPHIC] [TIFF OMITTED] TR28NO11.056
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
[[Page 73198]]
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. 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.
(10) Digestive: Liver (CPT Code 47000)
[GRAPHIC] [TIFF OMITTED] TR28NO11.057
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.
(11) Digestive: Abdomen, Peritoneum, and Omentum (CPT Codes 49082-
49084)
[GRAPHIC] [TIFF OMITTED] TR28NO11.058
The AMA RUC identified CPT codes 49080 and 49081 through the
Harvard-Valued--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.
(12) Nervous: Spine and Spinal Cord (CPT Codes 62367-62370)
[[Page 73199]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.059
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.
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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(13) Nervous: Extracranial Nerves, Peripheral Nerves, and Autonomic
Nervous System (CPT Codes 64633-64636)
[GRAPHIC] [TIFF OMITTED] TR28NO11.060
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 RUC-recommended
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.
[[Page 73200]]
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 RUC-recommended time. On an
interim final basis for CY 2012 we are finalizing a work RVU of 3.78
for CPT code 64635 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.
(14) Diagnostic Radiology: Abdomen (CPT Code 74174)
[GRAPHIC] [TIFF OMITTED] TR28NO11.061
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.
(15) Pathology and Laboratory: Cytopathology (CPT Codes 88104, 88106,
and 88108)
[GRAPHIC] [TIFF OMITTED] TR28NO11.062
CPT code 88104 was identified through the AMA RUC Relativity
Assessment Workgroup by the Harvard-Valued--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 post-service 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 intra-service 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
[[Page 73201]]
(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 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/.
(16) Psychiatry: Psychiatric Therapeutic Procedures (CPT Code 90845,
90867-90869)
[GRAPHIC] [TIFF OMITTED] TR28NO11.063
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 intra-service 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 intra-
service 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
[[Page 73202]]
not specifically discussed here, we agree with the AMA RUC/HCPAC-
recommended work RVUs and are setting as interim final the work RVUs
listed in Table 19.
(17) Ophthalmology: Special Ophthalmological Services (92071 and 92072)
[GRAPHIC] [TIFF OMITTED] TR28NO11.064
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 one-third. 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(18) Special Otorhinolaryngologic Services: Audiologic Function Tests
(CPT Codes 92558, 92587 and 92588)
[GRAPHIC] [TIFF OMITTED] TR28NO11.065
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
[[Page 73203]]
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.
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.
(19) Special Otorhinolaryngologic Services: Evaluative and Therapeutic
Services (CPT Codes 92605 and 92618)
[GRAPHIC] [TIFF OMITTED] TR28NO11.066
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 non-
speech-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.
(20) Cardiovascular: Cardiac Catheterization (93451-93568)
[[Page 73204]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.067
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 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 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
[[Page 73205]]
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 RUC-
recommended 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 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 duplication in service time, equipment or
supplies. Finally, commenters believed CMS did not base its 10-percent
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),
[[Page 73206]]
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 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).
[GRAPHIC] [TIFF OMITTED] TR28NO11.068
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/HCPAC-recommended 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
[[Page 73207]]
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 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/HCPAC-recommended work RVUs and are
setting as interim final the work RVUs listed in Table 19.
(22) Neurology and Neuromuscular Procedures: Nerve Conduction Tests
(CPT Codes 95885-95887)
[GRAPHIC] [TIFF OMITTED] TR28NO11.069
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.
(23) Neurology and Neuromuscular Procedures: Autonomic Function Tests
(CPT Codes 95938 and 95939)
[GRAPHIC] [TIFF OMITTED] TR28NO11.070
[[Page 73208]]
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 survey should be conducted for CY
2013.
We reviewed CPT codes 95938 (Short-latency 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 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
[[Page 73209]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.071
[[Page 73210]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.072
[[Page 73211]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.073
[[Page 73212]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.074
BILLING CODE 4120-01-C
2. Establishing Interim Final Direct PE RVUs for CY 2012
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 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.
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 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 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: http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage.
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 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 post-service 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
post-service 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 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 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 ``multi-layer
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 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, XIi-enhanced
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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from both 64633 and 64635. We note that the direct PE inputs for these
codes are interim for CY 2012, and we will consider any submitted
information regarding the use of this supply in furnishing these
services prior to finalizing the direct PE inputs for CY 2013.
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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-of-service.
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, 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).
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 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 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.
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IV. Allowed Expenditures for Physicians' Services and the Sustainable
Growth Rate
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-for-
service 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 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 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 physician-administered drugs from the definition of
``physicians' services'' in section 1848(f)(4)(A) of the Act for
purposes of computing the SGR and the levels of allowed expenditures
and actual expenditures beginning with CY 2010, and for all subsequent
years. Furthermore, in order to effectuate fully the Secretary's policy
decision to remove drugs from the definition of ``physicians'
services,'' we removed physician-administered drugs from the
calculation of allowed and actual expenditures for all prior years.
Thus, for purposes of determining allowed expenditures, actual
expenditures for all years, and SGRs beginning with CY 2010 and for all
subsequent years, we 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
[[Page 73269]]
the Medicare Administrative Contractors:
Physicians' services.
Services and supplies furnished incident to physicians'
services, except for the expenditures for drugs and biologicals which
are not usually self-administered by the patient.
Outpatient physical therapy services and outpatient
occupational therapy services.
Services of PAs, certified registered nurse anesthetists,
certified nurse midwives, clinical psychologists, clinical social
workers, nurse practitioners, and certified nurse specialists.
Screening tests for prostate cancer, colorectal cancer,
and glaucoma.
Screening mammography, screening pap smears, and screening
pelvic exams.
Diabetes outpatient self-management training (DSMT)
services.
MNT services.
Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests (including outpatient diagnostic laboratory
tests paid through intermediaries).
X-ray, radium, and radioactive isotope therapy.
Surgical dressings, splints, casts, and other devices used
for the reduction of fractures and dislocations.
Bone mass measurements.
An initial preventive physical exam.
Cardiovascular screening blood tests.
Diabetes screening tests.
Telehealth services.
Physician work and resources to establish and document the
need for a power mobility device.
Additional preventive services.
Pulmonary rehabilitation.
Cardiac rehabilitation.
Intensive cardiac rehabilitation.
Kidney disease education services.
Personalized prevention plan services.
2. Preliminary Estimate of the SGR for 2012
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-for-service
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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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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.129
[[Page 73270]]
4. Final Sustainable Growth Rate for CY 2010
The SGR for CY 2010 is 8.9 percent. Table 25 shows our preliminary
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 rule with comment period (75 FR 73278), and the final figures
determined using the best available data as of September 1, 2011.
[GRAPHIC] [TIFF OMITTED] TR28NO11.130
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
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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.131
[[Page 73271]]
We estimate that the weighted average increase in fees for
physicians' services in CY 2012 under the SGR will be 0.6 percent.
(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-for-service enrollees will
increase by 3.5 percent from CY 2011 to CY 2012. Table 27 illustrates
how this figure was determined.
[GRAPHIC] [TIFF OMITTED] TR28NO11.132
An important factor affecting fee-for-service enrollment is
beneficiary enrollment in MA plans. Because it is difficult to estimate
the size of the MA enrollee population before the start of a CY, at
this time we do not know how actual enrollment in MA plans will compare
to current estimates. For this reason, the estimate may change
substantially as actual Medicare fee-for-service enrollment for CY 2012
becomes known.
(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 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.
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 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.
[[Page 73272]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.133
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 rule with comment period was 0.2 percent (75 FR
73279).
(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 enrollees (excluding beneficiaries enrolled in Medicare
Advantage plans) increased by 1.8 percent in CY 2011. Table 29
illustrates how we determined this figure.
[GRAPHIC] [TIFF OMITTED] TR28NO11.134
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 fee-for-service enrollment.
(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.
(4) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2011
Compared With CY 2010
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.
(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 physician-administered drugs from the
definition of ``physicians' services'' for purposes of computing the
SGR and the levels of allowed expenditures and actual
[[Page 73273]]
expenditures beginning with CY 2010, and for all subsequent years,
drugs represent 0.0 percent of Medicare allowed charges included in the
SGR in CY 2010 and later years.
Table 30 shows the weighted-average of the MEI and laboratory price
changes for CY 2010.
[GRAPHIC] [TIFF OMITTED] TR28NO11.135
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
We estimate the change in the number of fee-for-service enrollees
(excluding beneficiaries enrolled in MA plans) 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.136
(3) Factor 3--Estimated Real Gross Domestic Product Per Capita Growth
in CY 2010
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.
(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
provisions regarding the physician fee schedule update, PQRI and E-
prescribing 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.
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.
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;
[[Page 73274]]
++ Dividing that difference by actual expenditures for those
services for the prior year as increased by the SGR for the year for
which the UAF is to be determined; and
++ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act requires the Secretary to
recalculate allowed expenditures consistent with section 1848(f)(3) of
the Act. As discussed previously, section 1848(f)(3) specifies that the
SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.137
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 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:
[GRAPHIC] [TIFF OMITTED] TR28NO11.138
[[Page 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)
[GRAPHIC] [TIFF OMITTED] TR28NO11.139
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.
C. The Percentage Change in the Medicare Economic Index (MEI)
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.
The MEI measures the weighted-average annual price change for
various inputs needed to produce physicians' services. The MEI is a
fixed-weight input price index, with an adjustment for the change in
economy-wide multifactor productivity. This index, which has CY 2006
base year weights, is comprised of two broad categories: (1)
Physician's own time; and (2) physician's practice expense (PE).
The physician's compensation (own time) component represents the
net income portion of business receipts and primarily reflects the
input of the physician's own time into the production of physicians'
services in physicians' offices. This category consists of two
subcomponents: (1) Wages and salaries; and (2) fringe benefits.
The physician's practice expense (PE) category represents
nonphysician inputs used in the production of services in physicians'
offices. This category consists of wages and salaries and fringe
benefits for nonphysician staff 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 http://www.bls.gov/mfp which is the link to the BLS historical
published data on the measure of MFP.
BILLING CODE 4120-01-P
[[Page 73276]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.140
[[Page 73277]]
BILLING CODE 4120-01-C
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
Generally, the PFS CF for a year is calculated in accordance with
section 1848(d)(1)(A) of the Act by multiplying the previous year's CF
by the PFS update.
We note section 101 of the Medicare Improvements and Extension Act,
Division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA)
provided a 1-year increase in the CY 2007 CF and specified that the CF
for CY 2008 must be computed as if the 1-year increase had never
applied. Section 101 of the Medicare, Medicaid, and SCHIP Extension Act
of 2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from
January 1, 2008, through June 30, 2008, and specified that the CF for
the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent
years must be computed as if the 6-month increase had never applied.
Section 131 of the MIPPA extended the increase in the CY 2008 CF that
applied during the first half of the year to the entire year, provided
for a 1.1 percent increase to the CY 2009 CF, and specified that the
CFs for CY 2010 and subsequent years must be computed as if the
increases for CYs 2007, 2008, and 2009 had never applied. Section
1011(a) of the DODAA and section 5 of the TEA specified a zero 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.141
We note payment for services under the PFS will be calculated as
follows:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU
malpractice x GPCI malpractice)] x CF.
2. Anesthesia Conversion Factor
We calculate the anesthesia CF as indicated in Table 35. Anesthesia
services do not have RVUs like other PFS services. Therefore, we
account for any necessary RVU adjustments through an adjustment to the
anesthesia CF to simulate changes to RVUs. More specifically, if there
is an adjustment to the work, PE, or malpractice RVUs, these
adjustments are applied to the respective shares of the anesthesia CF
as 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
[[Page 73278]]
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 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.
[GRAPHIC] [TIFF OMITTED] TR28NO11.142
V. Other Physician Fee Schedule Issues
A. Section 105: Extension of Payment for Technical Component of Certain
Physician Pathology Services
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 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.
[[Page 73279]]
2. Revisions to Payment for TC of Certain Physician Pathology Services
Consistent with this statutory change, we proposed to revise Sec.
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.
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 Sec. 415.130(d)(1) and (2) to reflect this
change.
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 1-day) 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 3-
day 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
[[Page 73280]]
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 1-day (instead of the previous 3-
days) 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, long-term 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 hospital-
operated 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.
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 3-day 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 3-day 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.
[[Page 73281]]
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 3-day 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'' 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 Sec.
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 Sec. 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 subject to the payment window. We encourage hospitals
to bring any other wholly owned or wholly operated Part B entities into
compliance with the 3-day 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 3-day payment window policy to these entities. Medicare pays RHCs
and FQHCs for their services through an all-inclusive 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 3-day 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 all-inclusive rate within which the
professional and technical portions are indeterminate, we do not
consider RHC or FQHC services to be subject to the 3-day 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
[[Page 73282]]
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 Sec. 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 3-day 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 non-physician 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 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 non-physician 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 admission-related, 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 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 Sec. 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
[[Page 73283]]
owned or wholly operated by a hospital, as defined in Sec.
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 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 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
[[Page 73284]]
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 Sec. Sec. 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 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 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 pre- and 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
[[Page 73285]]
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 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 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
[[Page 73286]]
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 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 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
[[Page 73287]]
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.
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 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 Sec. 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 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
[[Page 73288]]
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
volume-weighted 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--
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 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
[[Page 73289]]
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 volume-
weighted AMP calculated by the Inspector General is based on fewer NDCs
than the volume-weighted ASP calculated by CMS. Moreover, volume-
weighted ASPs are not adjusted by the Inspector General to reflect the
fewer number of NDCs in the volume-weighted 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
replace each missing NDC-level AMP with corresponding NDC-level ASP
data. The OIG then calculated a volume-weighted 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 market-related 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 Sec.
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 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
[[Page 73290]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.143
[[Page 73291]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.144
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, 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 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
[[Page 73292]]
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.
(3) Timeframe for and Duration of Price Substitutions
As stated in Sec. 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 Sec. 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 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 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.
[[Page 73293]]
[GRAPHIC] [TIFF OMITTED] TR28NO11.145
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 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). 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 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
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.
[[Page 73294]]
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
substitutions and the related regulation text at Sec.
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 volume-
weighted 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 AMP-based 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.
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
[[Page 73295]]
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 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 (http://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 prices, and time for CMS to respond. We will accept inquiries
about the list at the CMS ASP emailbox at [email protected].
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
[[Page 73296]]
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 Sec. 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.
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.
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
[[Page 73297]]
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: http://www.cms.gov/McrPartBDrugAvgSalesPrice/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 Sec. 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.
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 (http://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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[GRAPHIC] [TIFF OMITTED] TR28NO11.146
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: http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01_overview.asp. The Web
site will also 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.
4. Out of Scope Comments
We received comments pertaining to: (1) Coding and pricing for new
molecular diagnostic codes; (2) the continued use of G0440 and G0441 in
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.
B. Discussion of Budget Neutrality for the Chiropractic Services
Demonstration
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
[[Page 73299]]
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 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 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: http://www.cms.gov/reports/downloads/Stason_ChiroDemoEvalFinalRpt_2010.pdf.
The evaluation examined the impact of expanded coverage for
[[Page 73300]]
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 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
10-year 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 http://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 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
[[Page 73301]]
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.
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 Sec. 410.32. Our regulation at Sec. 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 Sec. 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
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
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 Sec. 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
[[Page 73302]]
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 Sec. 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 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 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
[[Page 73303]]
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 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.
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.
[[Page 73304]]
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 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
Sec. 410.32(d)(2)(i), as well as the hospital CoPs on medical record
services at Sec. 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 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.
[[Page 73305]]
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
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 Advisory Committee on Immunization Practices,
and the individual's health status, screening history, and age-
appropriate 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 self-management; 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 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 http://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
[[Page 73306]]
development of guidelines for evidence-based HRAs. The Interim Guidance
for Health Risk Assessments developed by the CDC is available on the
CMS Web site at http://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 follow-up 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 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 follow-
up. 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. 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 Sec. 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.