Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011
Federal RegisterJul 13, 2010
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 409, 410, 411, 413, 414, 415, and 424
[CMS-1503-P]
RIN 0938-AP79
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011
AGENCY:
Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION:
Proposed rule.
SUMMARY:
This proposed rule addresses proposed 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 provisions of both the Affordable Care Act and the Medicare Improvements for Patients and Providers Act of 2008. In addition, this proposed rule discusses payments under the Ambulance Fee Schedule, Clinical Laboratory Fee Schedule, payments to ESRD facilities, and payments for Part B drugs. Finally, the proposed rule includes a discussion regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for Durable Medical Equipment and Provider and Supplier Enrollment Issues associated with Air Ambulances. (See the Table of Contents for a listing of the specific issues addressed in this proposed rule.)
DATES:
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 24, 2010.
ADDRESSES:
In commenting, please refer to file code CMS-1503-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
Electronically.
You may submit electronic comments on this regulation to
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-1503-P, P.O. Box 8013, Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
By express or overnight mail.
You may send written comments to the following address only:
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1503-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4.
By hand or courier.
If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 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:
Rebecca Cole, (410) 786-4497, for issues related to physician payment and for all other issues not identified below.
Cheryl Gilbreath, (410) 786-5919, for issues related to payment for covered outpatient drugs and biologicals.
Roechel Kujawa, (410) 786-9111, for issues related to ambulance services.
Glenn McGuirk, (410) 786-5723, for clinical laboratory issues.
Randall Ricktor, (410) 786-4632, for Federally Qualified Health Center Issues.
Pauline Lapin, (410) 786-6883, for issues related to the chiropractic services demonstration BN issue.
Troy Barsky, (410)786-8873, or Kristin Bohl, (410)786-8680, for issues related to physician self-referral.
Troy Barsky, (410)786-8873, or Fred Grabau (410)786-0206, for issues related to timely filing rules.
Henry Richter, (410)786-4562, or Lisa Hubbard, (410)786-5472, for issues related to renal dialysis provisions and payments for end-stage renal disease facilities.
Diane Stern, (410)786-1133, for issues related to the physician quality reporting initiative and incentives for e-prescribing.
Sheila Roman, 410-786-6004, or Pamela Cheetham, 410-786-2259, for issues related to the Physician Resource Use Feedback Program and value-based purchasing.
Joel Kaiser, (410)786-4499, for issues related to the DME provisions.
Jim Bossenmeyer, (410)786-9317, for issues related to provider and supplier enrollment issues.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments:
All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:
http://www.regulations.gov.
Follow the search instructions on that Web site to view public comments.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 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 regulation's impact appears throughout the preamble, and therefore, is not discussed exclusively in section V. of this proposed rule.
I. Background
A. Development of the Relative Value System
1. Work RVUs
2. Practice Expense Relative Value Units (PE RVUs)
3. Resource-Based Malpractice (MP) RVUs
4. Refinements to the RVUs
5. Adjustments to RVUs Are Budget Neutral
B. Components of the Fee Schedule Payment Amounts
C. Most Recent Changes to Fee Schedule
II. Provisions of the Proposed 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
(i) Direct Costs
(ii) Indirect Costs
d. Facility and Nonfacility Costs
e. Services with Technical Components (TCs) and Professional Components (PCs)
f. Alternative Data Sources and Public Comments on Final Rule for 2010
g. PE RVU Methodology
(i) Setup File
(ii) Calculate the Direct Cost PE RVUs
(iii) Create the Indirect Cost PE RVUs
(iv) Calculate the Final PE RVUs
(v) Setup File Information
(vi) Equipment Cost per Minute
3. Proposed PE Revisions for CY 2011
a. Equipment Utilization Rate
b. HCPCS Code-Specific PE Proposals
(1) Biohazard Bags
(2) PE Inputs for Professional Component (PC) Only and Technical Component (TC) Only Codes Summing to Global Only Codes
(3) Equipment Time Inputs for Certain Diagnostic Tests
(4) Cobalt-57 Flood Source
(5) Venom Immunotherapy
(6) Equipment Redundancy
(7) Equipment Duplication
(8) Establishing Overall Direct PE Supply Price Inputs Based on Unit Prices and Quantities
c. AMA RUC Recommendations in CY 2010 for Changes to Direct PE Inputs
(1) Electrogastrography and Esophageal Function Test
(2) 64-Slice CT Scanner and Software
(3) Cystometrogram
(4) Breath Hydrogen Test
(5) Radiographic Fluoroscopic Room
d. Referral of Existing CPT Codes for AMA RUC Review
e. Updating Equipment and Supply Price Inputs for Existing Codes
B. Malpractice Relative Value Units (RVUs)
1. Background
2. Malpractice RVUs for New and Revised Services Effective Before the Next 5-Year Review
3. Revised Malpractice RVUs for Selected Disc Arthroplasty Services
C. Potentially Misvalued Codes 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. CY 2011 Identification and Review of Potentially Misvalued Services
a. Codes on the Multi-Specialty Points of Comparison List
b. Codes With Low Work RVUs Commonly Billed in Multiple Units Per Single Encounter
c. Codes With High Volume and Low Work RVUs
d. Codes With Site-of-Service-Anomalies
e. Codes With “23-hour” Stays
4. Expanding the Multiple Procedure Payment Reduction (MPPR) Policy to Additional Nonsurgical Services
a. Background
b. Proposed CY 2011 Expansion of the Imaging Technical Component MPPR Policy to Additional Combinations of Imaging Services
c. Proposed CY 2011 Expansion of the MPPR Policy to Therapy Services
5. High Cost Supplies
a. Background
b. Future Updates to the Prices of High-Cost Supplies
D. Geographic Practice Cost Indices (GPCIs)
1. Background
2. GPCI Update
a. Physician Work GPCIs
b. Practice Expense GPCIs
(1) The Affordable Care Act Requirements for PE GPCIs
(2) Summary of CY 2011 Proposed PE GPCIs
c. Malpractice GPCIs
d. General GPCI Update Process
3. Payment Localities
E. Physician Fee Schedule Update for CY 2011
1. Rebasing the Medicare Economic Index (MEI)
a. Background
b. Use of More Current Data
c. Rebasing and Revising Expense Categories in the MEI
(1) Developing the Weights for Use in the MEI
(2) Physician's Own Time
(3) Physician's Practice Expenses
(A) Non-Physician Employee Compensation
(B) Office Expenses
(C) Professional Liability Insurance (PLI) Expense
(D) Medical Equipment Expenses
(E) Medical Supplies Expenses
(F) All Other Professional Expenses
d. Selection of Price Proxies for Use in the MEI
(1) Expense Categories in the MEI
(A) Physician's Own Time (Physician Compensation)
(B) Nonphysician Employee Compensation
(C) Utilities
(D) Chemicals
(E) Paper
(F) Rubber and Plastics
(G) Telephone
(H) Postage
(I) All Other Labor-Intensive Services
(J) Fixed Capital
(K) Moveable Capital
(L) Professional Liability Insurance
(M) Medical Equipment
(N) Other Professional Expenses
(2) Productivity Adjustment to the MEI
e. Results of Rebasing
f. Adjustments to the RVU Shares to Match the Proposed Rebased MEI Weights
III. Code-Specific Issues for the PFS
A. Therapy Services
1. Outpatient Therapy Caps for CY 2011
2. Alternatives to Therapy Caps
a. Background
b. Current Activities
c. Potential Short-Term Approaches to Therapy Caps
B. Diabetes Self-Management Training (DSMT) Services (HCPCS Codes G0108 and G0109)
1. Background
2. Proposed Payment for DSMT Services
C. End-State Renal Disease Related Services for Home Dialysis (CPT Codes 90963, 90964, 90965, and 90966)
1. End-Stage Renal Disease Home Dialysis Monthly Capitation Payment Services (CPT Codes 90963, 90964, 90965, and 90966)
2. Daily and Monthly ESRD-Related Services (CPT Codes 90951 Through 90970)
D. Portable X-Ray Set-Up (HCPCS Code Q0092)
E. Pulmonary Rehabilitation Services (HCPCS Code G0424)
F. Application of Tissue-Cultured Skin Substitutes to Lower Extremities (HCPCS Codes GXXX1 and GXXX2)
G. Canalith Repositioning (CPT Code 95992)
H. Intranasal/Oral Immunization Codes (CPT Codes 90467, 90468, 90473, and 90474)
I. Refinement Panel Process
J. Remote Cardiac Monitoring Services (CPT Codes 93012, 93229, 93268, and 93271)
IV. Medicare Telehealth Services for the Physician Fee Schedule
A. Billing and Payment for Telehealth Services
1. History
2. Current Telehealth Billing and Payment Policies
B. Requests for Adding Services to the List of Medicare Telehealth Services
C. Submitted Requests for Addition to the List of Telehealth Services for CY 2011
(1) Individual KDE Services
(2) Individual DSMT Services
(3) Group KDE, MNT, DSMT, and HBAI Services
(4) Initial, Subsequent, and Discharge Day Management Hospital Care Services
(5) Initial, Subsequent, Discharge Day Management, and Other Nursing Facility Care Services
(6) Neuropsychological Testing Services
(7) Speech-Language Pathology Services
(8) Home Wound Care Services
D. Summary of CY 2011 Telehealth Proposals
V. Provisions of the Patient Protection and Affordable Care Act of 2010
A. Section 3002: Improvements to the Physician Quality Reporting System
B. Section 3003: Improvements to the Physician Feedback Program and Section 3007: Value-Based Payment Modifier Under the Physician Fee Schedule
1. Background
2. Effect of the Patient Protection and Affordable Care Act on the Program
3. Implementation of Sections 3003 and 3007 of the Affordable Care Act
4. Comments Sought on Specific Policy Topics Related to Both PPACA Sections 3003 and 3007
a. Risk Adjustment
b. Attribution
c. Benchmarking and Peer Groups
d. Cost and Quality Measures and Composite Measurement
C. Section 3102: Extension of the Work Geographic Index Floor and Revisions to the Practice Expense Geographic Adjustment Under the Medicare Physician Fee Schedule, and Protections for Frontier States as Amended by Section 10324 of the Affordable Care Act
D. Section 3103: Extension of Exceptions Process for Medicare Therapy Caps
E. Section 3104: Extension of Payment for Technical Component of Certain Physician Pathology Services
F. Section 3105: Extension of Ambulance Add-On
G. Section 3107: Extension of Physician Fee Schedule Mental Health Add-On
H. Section 3108: Permitting Physician Assistants to Order Post-Hospital Extended Care Services
I. Section 3111: Payment for Bone Density Tests
J. Section 3114: Improved Access for Certified Nurse Midwife Services
K. Section 3122: Extension of Medicare Reasonable Costs Payments for Certain Clinical Diagnostic Laboratory Tests Furnished to Hospital Patients in Certain Rural Areas
L. Section 3134: Misvalued Codes Under the Physician Fee Schedule
M. Section 3135: Modification of Equipment Utilization Factor for Advanced Imaging Services
1. Adjustment in Practice Expense to Reflect Higher Presumed Utilization
2. Adjustment in Technical Component “Discount” on Single-Session Imaging to Consecutive Body Parts
N. Section 3136: Revision for Payment for Power-Driven Wheelchairs
a. Payment Rules for Power Wheelchairs
b. Elimination of Lump Sum Payment for Standard Power Wheelchairs
c. Revision of Payment Amounts for Power Wheelchairs
O. Section 3139: Payment for Biosimilar Biological Products
P. Section 3401: Revision of Certain Market Basket Updates and Incorporation of Productivity Improvements Into Market Basket Updates That Do Not Already Incorporate Such Improvements
1. ESRD Market Basket Discussion
2. Productivity Adjustment Regarding Ambulance and Clinical Laboratory Fee Schedules
a. Ambulatory Surgery Centers (ASCs)
b. Ambulance Fee Schedule (AFS)
c. Clinical Lab Fee Schedule
Q. Section 4103: Medicare Coverage of Annual Wellness Visit Providing a Personalized Prevention Plan
1. Background
a. Medicare Coverage of Preventive Physical Examinations and Routine Checkups
b. Requirements for Coverage of an Annual Wellness Visit
2. Proposed Revisions
a. Proposed Revisions to § 411.15, Particular Services Excluded From Coverage
b. Proposed Revisions to Part 410, Subpart B—Medical and Other Health Services
(1) Definitions
(2) Requirements of the First Visit for Personalized Prevention Plan Services
(3) Requirements of Subsequent Visits for Personalized Prevention Plan Services
3. Payment for the Annual Wellness Visit Providing Personalized Prevention Plan Services (PPPS)
R. Section 4104: Removal of Barriers to Preventive Services in Medicare
1. Definition of “Preventive Services”
2. Deductible and Coinsurance for Preventive Services
3. Extension of Waiver of Deductible to Services Furnished in Connection With or in Relation to a Colorectal Cancer Screening Test that Becomes Diagnostic or Therapeutic
S. Section 5501: Expanding Access to Primary Care Services and General Surgery Services
1. Section 5501(a): Incentive Payment Program for Primary Care Services
a. Background
b. Proposed Primary Care Incentive Payment Program (PCIP)
2. Section 5501(b): Incentive Payment Program for Major Surgical Procedures Furnished in Health Professional Shortage Areas
a. Background
b. Proposed HPSA Surgical Incentive Payment Program (HSIP)
3. Sections 5501(a) and (b) of the Affordable Care Act and Payment for Critical Access Hospital Professional Services Under the Optional Method
T. Section 6003: Disclosure Requirements for In-Office Ancillary Services Exception to the Prohibition on Physician Self-Referral for Certain Imaging Services
1. Background
2. Proposed Disclosure Requirement
U. Section 6404: Maximum Period for Submission of Medicare Claims Reduced to Not More Than 12 Months
1. Background
2. Provisions of Affordable Care Act
V. Section 6410 and MIPPA: Adjustments to the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Acquisition Program
1. Background
2. Subdividing Large MSAs Under Round 2
3. Exclusions of Certain Areas After Round 2 and Prior to 2015
4. Expansion of Round 2
W. Section 10501(i)(3)—Proposed Collection of HCPCS Data for Development and Implementation of a Prospective Payment System for the Medicare Federally Qualified Health Center Program
VI. Other Provisions of the Proposed Regulation
A. Part B Drug Payment: Average Sales Price (ASP) Issues
1. “Carry Over” ASP
2. Partial Quarter ASP Data
3. Determining the Payment Amount for Drugs and Biologicals Which Include Intentional Overfill
4. WAMP/AMP
5. Price Substitutions
a. AMP threshold
b. AMP Price Substitution
B. Ambulance Fee Schedule: Proposed Policy for Reporting Units When Billing for Ambulance Fractional Mileage
1. Policy for Reporting Units When Billing for Ambulance Fractional Mileage or Other Services
a. History of Medicare Ambulance Services
(1) Statutory Coverage of Ambulance Services
(2) Medicare Regulations for Ambulance Services
b. Mileage Reporting
(1) Background and Current Process for Reporting Ambulance Mileage
(2) Potential for Inaccuracies in Reporting Units and Associated Risks
(3) Billing of Fractional Units for Mileage
C. Clinical Laboratory Fee Schedule: Signature on Requisition
D. Discussion of Chiropractic Services Demonstration
E. Provisions Related to Payment for Renal Dialysis Services Furnished by End-Stage Renal Disease (ESRD) Facilities
1. CY 2005 Provisions
2. CY 2006 Provisions
3. CY 2007 Provisions
4. CY 2008 Provisions
5. CY 2009 Updates
6. CY 2010 Updates
7. Proposals for CY 2011
a. MIPPA Provisions
b. Affordable Care Act Provision
8. Proposed Update to the Drug Add-On Adjustment to the Composite Rate
a. Estimating Growth in Expenditures for Drugs and Biologicals for CY 2010
b. Estimating Growth in Expenditures for Drugs and Biologicals in CY 2011
c. Estimating Per Patient Growth
d. Applying the Proposed Growth Update to the Drug Add-On Adjustment
e. Proposed Update to the Drug Add-On Adjustment
f. Proposed Update to the Geographic Adjustments to the Composite Rate
g. Proposed Updates to Core-Based Statistical Area (CBSA) Definitions
h. Proposed Updated Wage Index Values
i. Reduction to the ESRD Wage Index Floor
j. Proposed Wage Index Values for Areas With No Hospital Data
k. Budget Neutrality Adjustment
l. ESRD Wage Index Tables
F. Issues Related to the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)
1. Section 131: Physician Payment, Efficiency, and Quality Improvements—
Physician Quality Reporting Initiative (PQRI)
a. Program Background and Statutory Authority
b. Incentive Payments for the 2011 PQRI
c. Proposed 2011 Reporting Periods for Individual Eligible Professionals
d. Proposed 2011 PQRI Reporting Mechanisms for Individual Eligible Professionals
(1) Proposed Requirements for Individual Eligible Professionals Who Choose the Claims-Based Reporting Mechanism
(2) Proposed Requirements for Individual Eligible Professionals Who Choose the Registry-Based Reporting Mechanism
(3) Proposed Requirements for Individual Eligible Professionals Who Choose the EHR-Based Reporting Mechanism
(4) Proposed Qualification Requirements for Registries
(5) Proposed Qualification Requirements for EHR Vendors and Their Products
e. Proposed Criteria for Satisfactory Reporting of Individual Quality Measures for Individual Eligible Professionals
f. Proposed Criteria for Satisfactory Reporting Measures Groups for Individual Eligible Professionals
g. Proposed Reporting Option for Satisfactory Reporting on Quality Measures by Group Practices
(1) Group Practice Reporting Option—GPRO I
(2) Process for Physician Group Practices to Participate as Group Practices and Criteria for Satisfactory Reporting
h. Statutory Requirements and Other Considerations for 2011 PQRI Measures
(1) Statutory Requirements for 2011 PQRI Measures
(2) Other Considerations for Measures Proposed for Inclusion in the 2011 PQRI
i. Proposed 2011 PQRI Quality Measures for Individual Eligible Professionals
(1) Proposed 2011 Individual Quality Measures Selected From the 2010 PQRI Quality Measures Set Available for Claims Based Reporting and Registry-Based Reporting
(2) Proposed 2011 Individual Quality Measures Selected From the 2010 PQRI Quality Measures Set Available for Registry Based Reporting Only
(3) New Individual Quality Measures Selected for Proposed for 2011
(4) Proposed 2011 Measures Available for EHR-Based Reporting
(5) Measures Proposed for Inclusion in 2011 Measures Groups
j. Proposed 2011 PQRI Quality Measures for Physician Groups Selected to Participate in the Group Practice Reporting Option
k. Public Reporting of PQRI Data
l. Affordable Care Act Extension of Incentive for PQRI Program
m. Affordable Care Act Timely Feedback Reports
n. Affordable Care Act Informal Appeals Process
o. Affordable Care Act Maintenance of Certification Program
p. Affordable Care Act Physician Compare Web Site
q. Affordable Care Act Integration of PQRI EHR Measures and HITECH Measures in Years After 2011
2. Section 132: Incentives for Electronic Prescribing (eRx)—The Electronic Prescribing Incentive Program
a. Program Background and Statutory Authority
b. The 2011 Reporting Period for the eRx Incentive Program
c. Proposed Criteria for Determination of Successful Electronic Prescriber for Eligible Professionals
(1) Reporting the Electronic Prescribing Measure
(2) The Reporting Denominator for the Electronic Prescribing Measure
(3) Qualified Electronic Prescribing System—Required Functionalities and Part D eRx Standards
(4) The Reporting Numerator for the Electronic Prescribing Measure
(5) Criteria for Successful Reporting of the Electronic Prescribing Measure
d. Determination of the 2011 Incentive Payment Amount for Individual Eligible Professionals Who Are Successful Electronic Prescribers
e. Proposed Reporting Option for Satisfactory Reporting of the Electronic Prescribing Measure by Group Practices
(1) Definition of “Group Practice”
(2) Process for Group Practices to Participate as Group Practices and Criteria for Successful Reporting of the Electronic Prescribing Measure by Group Practices
f. Public Reporting of Names of Successful Electronic Prescribers
G. DMEPOS Competitive Bidding Program Issues
1. Implementation of a National Mail Order Competitive Bidding Program for Diabetic Testing Supplies
a. Revision of the Definition of “Mail Order”
(1) Legislative and Regulatory History of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program
(2) National Mail Order Competitive Bidding Program
(3) The MIPPA and the Medicare DMEPOS Competitive Bidding Program
(4) Competition for Mail Order Diabetic Supplies Under Round 1 of the Medicare DMEPOS Competitive Bidding Program
b. Overview of Proposed Rule
c. Future Competitions for Diabetic Testing Supplies
d. Definition of Mail Order Item
e. Special Rule in Case of National Mail Order Competition for Diabetic Testing Strips
f. Anti-Switching Rule in Case of National Mail Order Competition for Diabetic Test Strips
2. Off-the-Shelf (OTS) Orthotics Exemption
3. Changes to Payment for Oxygen and Oxygen Equipment
a. Background
b. Furnishing Oxygen Equipment After the 36-Month Rental Period (Cap)
c. Furnishing Oxygen Equipment During the 36-Month Rental Period (Cap)
4. Grandfathering Rules Resulting in Extra Payments to Contract Suppliers Under the DMEPOS Competitive Bidding Program
5. Appeals Process
a. Background
b. Proposed Appeals Process
(1) Purpose and Definitions: (§ 414.402)
(2) Applicability
(3) Contract Termination
(4) Notice of Termination
(5) Corrective Action Plan
(6) Right to Request a Hearing by the CBIC Hearing Officer
(7) Scheduling of the Hearing
(8) Burden of Proof
(9) Role of the Hearing Officer
(10) CMS's Final Determination
(11) Effective Date of the Contract Termination
(12) Effect of Contract Termination
H. Provider and Supplier Enrollment Issue: Air Ambulance Provision
I. Technical Corrections
1. Physical Therapy, Occupational Therapy, and Speech-Language Pathology
2. Scope of Benefits
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Regulatory Impact Analysis
A. RVU Impacts
1. Resource Based Work, PE, and Malpractice RVUs
2. CY 2011 PFS Impact Discussion
a. Changes in RVUs
b. Combined Impact
B. Geographic Practice Cost Indices (GPCIs)
C. Rebasing and Revising of the MEI
D. The Affordable Care Act Provisions
1. Section 3103: Extension of Exceptions Process for Medicare Therapy Caps
2. Section 3104: Extension of Payment for Technical Component of Certain Physician Pathology Services
3. Sections 3105 and 10311: Extension of Ambulance Add-Ons
4. Section 3107: Extension of Physician Fee Schedule Mental Health Add-On
5. Section 3111: Payment for Bone Density Tests
6. Section 3122: Extension of Medicare Reasonable Costs Payments for Certain Clinical Diagnostic Laboratory Tests Furnished to Hospital Patients in Certain Rural Areas
7. Section 3135: Modification of Equipment Utilization Factor for Advanced Imaging Services
8. Section 3136: Revisions in Payments for Power Wheelchairs
9. Section 3401: Revisions of Certain Market Basket Updates and Incorporation of Productivity Adjustments
10. Section 4103: Medicare Coverage of Annual Wellness Visit Providing a Personalized Prevention Plan
11. Section 4104: Removal of Barriers to Preventive Services in Medicare
12. Section 5501: Expanding Access to Primary Care Services and General Surgery Services
13. Section 6003: Disclosure Requirements for In-Office Ancillary Services Exception to the Prohibition of Physician Self-referral for Certain Imaging Services
14. Section 6404: Maximum Period for Submission of Medicare Claims Reduced to Not More Than 12 Months
E. Other Provisions of the Proposed Regulation
1. Part B Drug Payment: ASP Issues
2. Ambulance Fee Schedule: Proposed Policy for Reporting Units When Billing for Ambulance Fractional Mileage
3. Chiropractic Services Demonstration
4. Renal Dialysis Services Furnished by ESRD Facilities
5. Section 131(b) of the MIPPA: Physician Payment, Efficiency, and Quality Improvements—Physician Quality Reporting Initiative (PQRI)
6. Section 132 of the MIPPA: Incentives for Electronic Prescribing (eRx)—The eRx Incentive Program
7 RHC/FQHC Issues
8. Durable Medical Equipment-Related Issues
a. Off-the-Shelf (OTS) Orthotics Exemption
b. Changes to Payment for Oxygen Equipment
F. Alternatives Considered
G. Impact on Beneficiaries
H. Accounting Statement
Regulation Text
Addendum A—Explanation and Use of Addendum B
Addendum B—Proposed Relative Value Units and Related Information Used in Determining Medicare Payments for CY 2011
Addendum C—[Reserved]
Addendum D—Proposed CY 2011 Geographic Adjustment Factors (GAFs)
Addendum E—Proposed CY 2011 Geographic Practice Cost Indices (GPCIs) by State and Medicare Locality
Addendum F—Proposed CY 2011 Diagnostic Imaging Services Subject to the Multiple Procedure Payment Reduction
Addendum G—CPT/HCPCS Imaging Codes Defined by Section 5102(b) of the DRA
Addendum H—Proposed CY 2011 “Always Therapy” Services* Subject to the Multiple Procedure Payment Reduction
Addendum I—[Reserved]
Addendum J—[Reserved]
Addendum K—Proposed CY 2011 ESRD Wage Index for Urban Areas Based on CBSA Labor Market Areas
Addendum L—Proposed CY 2011 ESRD Wage Index for Rural Areas Based on CBSA Labor Market Areas
Acronyms
In addition, because of the many organizations and terms to which we refer by acronym in this proposed rule, we are listing these acronyms and their corresponding terms in alphabetical order below:
AA Anesthesiologist assistant
AACVPR American Association of Cardiovascular and Pulmonary Rehabilitation
AANA American Association of Nurse Anesthetists
ABMS American Board of Medical Specialties
ABN Advanced Beneficiary Notice
ACA “Affordable Care Act”
ACC American College of Cardiology
ACGME Accreditation Council on Graduate Medical Education
ACLS Advanced cardiac life support
ACR American College of Radiology
AED Automated external defibrillator
AFROC Association of Freestanding Radiation Oncology Centers
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-DE American Medical Association Drug Evaluations
AMP Average manufacturer price
AO Accreditation organization
AOA American Osteopathic Association
APA American Psychological Association
APTA American Physical Therapy Association
ARRA American Recovery and Reinvestment Act (Pub. L. 111-5)
ASC Ambulatory surgical center
ASP Average sales price
ASRT American Society of Radiologic Technologists
ASTRO American Society for Therapeutic Radiology and Oncology
ATA American Telemedicine Association
AWP Average wholesale price
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 Basic Life support
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
CBIC Competitive Bidding Implementation Contractor
CBP Competitive Bidding Program
CBSA Core-Based Statistical Area
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
CMHC Community mental health center
CMP Civil money penalty
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 customers
CPR Cardiopulmonary resuscitation
CPT [Physicians'] Current Procedural Terminology (4th Edition, 2002, copyrighted by the American Medical Association)
CR Cardiac rehabilitation
CRNA Certified registered nurse anesthetist
CRP Canalith repositioning
CRT Certified respiratory therapist
CSW Clinical social worker
CY Calendar year
DEA Drug Enforcement Agency
DHS Designated health services
DME Durable medical equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies
DOQ Doctor's Office Quality
DOS Date of service
DRA Deficit Reduction Act of 2005 (Pub. L. 109-171)
DSMT Diabetes self-management training
E/M Evaluation and management
EDI Electronic data interchange
EEG Electroencephalogram
EHR Electronic health record
EKG Electrocardiogram
EMG Electromyogram
EMTALA Emergency Medical Treatment and Active Labor Act
EOG Electro-oculogram
EPO Erythopoeitin
ESRD End-stage renal disease
FAX Facsimile
FDA Food and Drug Administration (HHS)
FFS Fee-for-service
FR
Federal Register
GAF Geographic adjustment factor
GAO General Accounting Office
GEM Generating Medicare [Physician Quality Performance Measurement Results]
GFR Glomerular filtration rate
GPO Group purchasing organization
GPCI Geographic practice cost index
HAC Hospital-acquired conditions
HBAI Health and behavior assessment and intervention
HCPAC Health Care Professional Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HDRT High dose radiation therapy
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
HOPD Hospital outpatient department
HPSA Health Professional Shortage Area
HRSA Health Resources Services Administration (HHS)
IACS Individuals Access to CMS Systems
ICD International Classification of Diseases
ICF Intermediate care facilities
ICR Intensive cardiac rehabilitation
ICR Information collection requirement
IDTF Independent diagnostic testing facility
IFC Interim final rule with comment period
IMRT Intensity-Modulated Radiation Therapy
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
MA Medicare Advantage
MA-PD Medicare Advantage—Prescription Drug Plans
MAV Measure Applicability Validation
MCMP Medicare Care Management Performance
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
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)
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173)
MNT Medical nutrition therapy
MOC Maintenance of certification
MP Malpractice
MPPR Multiple procedure payment reduction
MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539)
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan statistical area
NBRC National Board for Respiratory Care
NCD National Coverage Determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NDC National drug code
NF Nursing facility
NISTA National Institute of Standards and Technology Act
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQF National Quality Forum
NRC Nuclear Regulatory Commission
OACT [CMS'] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
ODF Open door forum
OGPE Oxygen generating portable equipment
OIG Office of 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
PAT Performance assessment tool
PC Professional component
PCI Percutaneous coronary intervention
PDP Prescription drug plan
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
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
PPI Producer price index
PPIS Physician Practice Information Survey
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
PTCA Percutaneous transluminal coronary angioplasty
PVBP Physician and Other Health Professional Value-Based Purchasing Workgroup
RA Radiology assistant
RBMA Radiology Business Management Association
RFA Regulatory Flexibility Act
RHC Rural health clinic
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
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SLP Speech-language pathology
SMS [AMA's] Socioeconomic Monitoring System
SNF Skilled nursing facility
SOR System of record
SRS Stereotactic radiosurgery
STARS Services Tracking and Reporting System
TC Technical Component
TIN Tax identification number
TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432)
TTO Transtracheal oxygen
UPMC University of Pittsburgh Medical Center
USDE United States Department of Education
USP-DI United States Pharmacopoeia-Drug Information
VBP Value-based purchasing
WAMP Widely available market price
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 proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and eligible nonphysician practitioners (such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives, psychologists, or social workers) that are permitted to furnish and bill Medicare under the PFS for the services under discussion.
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 were 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 on our review of recommendations received from the American Medical Association's (AMA) 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 physician's 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 physicians' service in a final rule, 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 nonphysicians (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 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. 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 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 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 2011 using this methodology, unless otherwise noted.
In the CY 2010 PFS final rule with comment period, we updated the PE/hour (HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). 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 PE/HR values (74 FR 61752).
3. Resource-Based Malpractice (MP) RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act requiring us to implement resource-based malpractice (MP) RVUs for services furnished on or after 2000. The resource-based MP RVUs were implemented in the PFS final rule 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.
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 the physician work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The second Five-Year Review 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 physician work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. (
Note:
Additional codes relating to the third Five-Year Review of physician work RVUs were addressed in the CY 2008 PFS final rule with comment period (72 FR 66360).) The fourth Five-Year Review of physician 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). Changes due to the fourth Five-Year Review of physician work RVUs will be effective January 1, 2012.
In 1999, the AMA's 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. Therefore, the next Five-Year Review of PE RVUs will be addressed in CY 2014.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first Five-Year Review of the MP 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.
5. Adjustments to RVUs Are Budget Neutral
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. 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.
As explained in the CY 2009 PFS final rule with comment period (73FR 69730), as required by section 133(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), the separate budget neutrality (BN) adjustor resulting from the third Five-Year Review of physician work RVUs is being applied to the CF beginning in CY 2009 rather than to the work RVUs.
For CY 2010, we adopted a number of new payment policies for which we estimated the potential for a redistributive effect under the PFS, including the use of the new PPIS data to develop the specialty-specific PE/HR used for the PE RVUs (74 FR 61749 through 61752) and the elimination of the reporting of all CPT consultation codes in order to allow for correct and consistent coding and appropriate payment for evaluation and management services under the PFS (74 FR 61767 through 61775). We recognize that clinical experience with these new PFS policies has been growing over the first 6 months of CY 2010 and, as we seek to improve future PFS payment accuracy for services, we are interested in public comments on the perspectives of physicians and nonphysician practitioners caring for Medicare beneficiaries under the current PFS coding and payment methodologies for physicians' services.
B. Components of the Fee Schedule Payment Amounts
To calculate the payment for every physicians' service, the components of the fee schedule (physician work, PE, and MP RVUs) are adjusted by a geographic practice cost index (GPCI). The GPCIs reflect the relative costs of physician work, PE, and malpractice expense in an area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:
Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU malpractice × GPCI malpractice)] × CF
C. Most Recent Changes to the Fee Schedule
The CY 2010 PFS final rule with comment period (74 FR 61738) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized some of the CY 2009 interim RVUs and implemented interim RVUs for new and revised codes for CY 2010 to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. The CY 2010 PFS final rule with comment period also addressed other policies, as well as certain provisions of the MIPPA.
As required by the statute at the time of its issuance on October 30, 2009, the CY 2010 PFS final rule with comment period announced the following for CY 2010: The PFS update of −21.2 percent; the initial estimate for the sustainable growth rate of −8.8 percent; and the CF of $28.4061.
On December 10, 2009, we published a correction notice (74 FR 65449) to correct several technical and typographical errors that occurred in the CY 2010 PFS final rule with comment period. This correction notice announced a revised CF for CY 2010 of $28.3895.
On December 19, 2009, the Department of Defense Appropriations Act, 2010 (Pub. L. 111-118) was signed into law. Section 1011 of Pub. L. 111-118 provided a 2-month zero percent update to the CY 2010 PFS effective only for dates of service from January 1, 2010 through February 28, 2010.
On March 2, 2010, the Temporary Extension Act of 2010 (Pub. L. 111-144) was signed into law. Section 2 of Pub. L. 111-144 extended the zero percent update to the PFS through March 31, 2010 that was in effect for claims with dates of service from January 1, 2010 through February 28, 2010.
In addition, on April 15, 2010, the Continuing Extension Act of 2010 (Pub. L. 111-157) was signed into law. Section 4 of Public Law 111-157 extended through May 31, 2010 the zero percent update to the PFS that was in effect for claims with dates of services from January 1, 2010 through March 31, 2010. The law is retroactive to April 1, 2010.
In the May 11, 2010
Federal Register
(75 FR 26350), we published a subsequent correction notice to correct several technical and typographical errors that occurred in the CY 2010 PFS final rule with comment period and the December 10, 2009 correction notice. The May 11, 2010 correction notice announced a revised CF for CY 2010 of $28.3895.
Finally, on March 23, 2010 the Patient Protection and Affordable Care Act (Pub. L. 111-148) was signed into law. Shortly thereafter, on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) was signed into law. These two laws are discussed in this proposed rule and are collectively referred to as the “Affordable Care Act” (ACA) throughout this proposed rule.
II. Provisions of the Proposed 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 CMS 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 American Medical Association's (AMA's) Relative Value Update Committee (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 (PE/HR) in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). These surveys were conducted from 1995 through 1999. For several specialties that collected additional PE/HR data through supplemental surveys, we incorporated these data in developing the PE/HR values used annually.
While the SMS was not specifically designed for the purpose of establishing PE RVUs, we found these data to be the best available at the time. The SMS was a multispecialty survey effort conducted using a consistent survey instrument and method across specialties. The survey sample was randomly drawn from the AMA Physician Masterfile to ensure national representativeness. The AMA discontinued the SMS survey in 1999. As required by the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), we also established a process by which specialty groups could submit supplemental PE data. In the May 3, 2000
Federal Register
, we issued the Medicare Program; Criteria for Submitting Supplemental Practice Expense Survey Data interim final rule (65 FR 25664) in which we established criteria for acceptance of supplemental data. The criteria were modified in the CY 2001 and CY 2003 PFS final rules with comment period (65 FR 65380 and 67 FR 79971, respectively). In addition to the SMS, we previously used supplemental survey data for the following specialties: Cardiology; dermatology; gastroenterology; radiology; cardiothoracic surgery; vascular surgery; physical and occupational therapy; independent laboratories; allergy/immunology; independent diagnostic testing facilities (IDTFs); radiation oncology; medical oncology; and urology.
Because the SMS data and the supplemental survey data were from different time periods, we historically inflated them by the Medicare Economic Index (MEI) to put them on as comparable a time basis as we could when calculating the PE RVUs. This MEI proxy was necessary in the past due to the lack of contemporaneous, consistently collected, and comprehensive multispecialty survey data.
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 was designed to update the specialty-specific PE/HR data used to develop PE RVUs. The AMA and the CMS contractor, The Lewin Group (Lewin), analyzed the PPIS data and calculated the PE/HR for physician and nonphysician specialties, respectively. The AMA's summary worksheets and Lewin's final report are available on the CMS Web site at
http://www.cms.gov/PhysicianFeeSched/PFSFRN/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=4&sortOrder=descending&itemID=CMS1223902&intNumPerPage=10
. (
See
downloads labeled AMA PPIS Worksheets 1-3 and Physician Practice Expense non MDDO Final Report)
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 (75/25 for CY 2010, 50/50 for CY 2011, 25/75 for CY 2012, and 0/100 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, and we do not know how 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 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.
Finally, 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. In the CY 2010 PFS final rule with comment period (74 FR 61753), we miscalculated the indirect PE/HR for IDTFs as part of this update process. Therefore, for CY 2011, we are proposing to use a revised indirect PE/HR of $479.81 for IDTFs, consistent with our final policy to update the indirect PE/HR values from prior supplemental survey data that we are continuing to use in order to put these data on a comparable basis with the PPIS data. This revision changes the IDTF indirect percentage from 51 percent to 50 percent.
Previously, CMS has 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.
In the CY 2010 PFS final rule with comment period (74 FR 61752), we agreed that, under the current PE methodology, the PPIS data for registered dieticians should not be used in the calculation of PE RVUs since these dieticians are paid 85 percent of what a physician would be paid for providing the service. To include their survey data in the PE calculation would influence the ratesetting by incorporating what the services would be paid if performed by registered dieticians and not strictly what the payment rates would be if provided by physicians. We further stated that we would utilize the “All Physicians” PE/HR, as derived from the PPIS, in the calculation of resource-based PE RVUs in lieu of the PE/HR associated with registered dieticians. In the resource-based PE methodology for CY 2010, while we removed the specialty of registered dieticians from the ratesetting step we did not assign the “All Physicians” PE/HR to services furnished by registered dieticians. Instead, we allowed the PE/HR for those services to be generated by a weighted average of all the physician specialties that also furnished the services. This method was consistent with our policy to not use the registered dietician PPIS PE/HR in calculating the PE RVUs for services furnished by registered dieticians but we did not actually crosswalk the specialty of registered dietician to the “All Physicians” PE/HR data as we had intended according to the final policy. Nevertheless, we are affirming for CY 2011 that the proposed resource-based PE RVUs have been calculated in accordance with the final policy adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) for registered dietician services that crosswalks the specialty to the “All Physicians” PE/HR data.
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2011 is the second year of the 4-year transition to the PE RVUs calculated using the PPIS data. Therefore, in general, the CY 2011 PE RVUs are a 50/50 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 above. Note that the reductions in the PE RVUs for expensive diagnostic imaging equipment attributable to the change to an equipment utilization rate assumption of 75 percent (
see
74 FR 61753 through 61755 and section II.A.3. of this proposed rule) are not subject to the transition.
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.
(i)
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.
(ii)
Indirect costs.
Section II.A.2.b. of this proposed rule describes the current data sources for specialty-specific indirect costs used in our PE calculations. We 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 below.
• For a given service, we use the direct portion of the PE RVUs calculated as described above 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.
• 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 example above 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. Alternative Data Sources and Public Comments on Final Rule for 2010.
In the CY 2010 PFS final rule with comment period (74 FR 61749 through 61750), we discussed the Medicare Payment Advisory Commission's (MedPAC's) comment that in the future, “CMS should consider alternatives to collecting specialty-specific cost data or options to decrease the reliance on such data.” We agreed with MedPAC that it would be appropriate to consider the future of the PE RVUs moving forward. We sought comments from other stakeholders on the issues raised by MedPAC for the future. In particular, we requested public comments regarding MedPAC's suggestion that we consider alternatives for collecting specialty-specific cost data or options to decrease the reliance on such data. We noted MedPAC's comment that, “CMS should consider if Medicare or provider groups should sponsor future data collection efforts, if participation should be voluntary (such as surveys) or mandatory (such as cost reports), and whether a nationally representative sample of practitioners would be sufficient for either a survey or cost reports.” MedPAC also stated that one option for decreasing the reliance on specialty-specific cost data would be the elimination of the use of indirect PE/HR data in the last step of establishing the indirect cost portion of the PE RVUs as described previously.
Almost all of the commenters on the CY 2010 PFS final rule with comment period that addressed this issue expressed a general willingness to work with CMS on methodological improvements or future data collection efforts. Although no commenters detailed a comprehensive overall alternative methodology, several commenters did provide suggestions regarding future data collection efforts and specific aspects of the current methodology.
The commenters that addressed the issue of surveys supported the use of surveys if they yielded accurate PE information. The few commenters that addressed the issue of cost reports were opposed to physician cost reports. The commenters varied with respect to their opinions regarding whether data collection efforts should be led by organized medicine, individual specialty societies, or CMS. Several commenters that addressed the issue of voluntary versus mandatory data collection efforts supported voluntary data collection efforts and opposed mandatory data collection efforts.
Some commenters recommended no changes to the methodology or PE data in the near future. Other commenters indicated that the methodology and data changes needed to be made for CY 2011. Although most commenters did not directly address the use of the indirect PE/HR data, those that did predominately opposed the elimination of the use of these data.
Many commenters addressed specifics of the PE methodology (as further described in section II.A.2.c. of this proposed rule). Some were opposed to the scaling factor applied in the development of the direct PE portion of the PE RVUs so that in the aggregate the direct portion of the PE RVUs do not exceed the proportion indicated by the survey data (
See
Step 4 in g.(ii) below). Several of these commenters advocated the elimination of this direct scaling factor, while others indicated that the issue should be examined more closely.
A few commenters recommended that physician work not be used as an allocator in the development of the indirect portion of the PE RVUs as described earlier in this section. A few indicated that physician time, but not physician work, should be used in the allocation. Other commenters suggested that indirect costs should be allocated solely on the basis of direct costs.
We note that many of the issues raised by commenters on the CY 2010 PFS final rule with comment period are similar to issues raised in the development of the original resource-based PE methodology and in subsequent revisions to the methodology, including the adoption of the bottom-up methodology. While we are not proposing a broad methodological change or broad data collection effort in this CY 2011 PFS proposed rule, we invite comments on our summary of the issues raised by the commenters on the CY 2010 PFS final rule with comment period, as presented above. The complete public comments on that final rule are available for public review at
http://www.regulations.gov
by entering “CMS-1413-FC” in the search box on the main page.
g. 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).
(i) 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.
(ii) 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.
(iii) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6:
Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.
Step 7:
Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global 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 the 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.
(iv) 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, MEI rebasing adjustment, and multiple procedure payment reduction (MPPR) adjustment.
The final PE BN adjustment is calculated by comparing the results of Step 18 (prior to the MEI rebasing and MPPR adjustments) 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” below in this section.)
As discussed in section II.E.1. of this proposed rule, we are proposing to rebase and revise the Medicare Economic Index (MEI) for CY 2011. As discussed in section II.C.4. of this proposed rule, section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service. There is inherent duplication in the PE associated with those services which are frequently furnished together, so reducing PFS payment for the second and subsequent services to account for the efficiencies in multiple service sessions may be appropriate. Consistent with this provision of the ACA, we are proposing a limited expansion of the current MPPR policy for imaging services for CY 2011 and a new MPPR policy for therapy services.
(v) Setup File Information
• Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1.
Table 1—Specialties Excluded From Ratesetting Calculation
Specialty code
Specialty description
42
Certified nurse midwife.
49
Ambulatory surgical center.
50
Nurse practitioner.
51
Medical supply company with certified orthotist.
52
Medical supply company with certified prosthetist.
53
Medical supply company with certified prosthetist-orthotist.
54
Medical supply company not included in 51, 52, or 53.
55
Individual certified orthotist.
56
Individual certified prosthetist.
57
Individual certified prosthetist-orthotist.
58
Individuals not included in 55, 56, or 57.
59
Ambulance service supplier,
e.g.,
private ambulance companies, funeral homes, etc.
60
Public health or welfare agencies.
61
Voluntary health or charitable agencies.
73
Mass immunization roster biller.
74
Radiation therapy centers.
87
All other suppliers (
e.g.,
drug and department stores).
88
Unknown supplier/provider specialty.
89
Certified clinical nurse specialist.
95
Competitive Acquisition Program (CAP) Vendor.
96
Optician.
A0
Hospital.
A1
SNF.
A2
Intermediate care nursing facility.
A3
Nursing facility, other.
A4
HHA.
A5
Pharmacy.
A6
Medical supply company with respiratory therapist.
A7
Department store.
1
Supplier of oxygen and/or oxygen related equipment.
2
Pedorthic personnel.
3
Medical supply company with pedorthic personnel.
• Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
• Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
• Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
• Payment modifiers: Payment modifiers are accounted for in the creation of the file. 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 proposed rule.
(vi) 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 this proposed rule) 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.
Note:
The use of any particular conversion factor (CF) in Table 2 to illustrate the PE calculation has no effect on the resulting RVUs.
Table 2—Calculation of PE RVUs Under Methodology for Selected Codes
Step
Source
Formula
99213
Office visit, est nonfacility
33533
CABG, arterial, single facility
71020
Chest x-ray
nonfacility
71020-TC
Chest x-ray
nonfacility
71020-26
Chest x-ray
nonfacility
93000
ECG, complete nonfacility
93005
ECG, tracing nonfacility
93010
ECG, report
nonfacility
(1) Labor cost (Lab)
Step 1
AMA
13.32
77.52
5.74
5.74
0.00
6.12
6.12
0.00
(2) Suppy cost (Sup)
Step 1
AMA
2.98
7.34
3.39
3.39
0.00
1.19
1.19
0.00
(3) Equipment cost (Eqp)
Step 1
AMA
0.19
0.65
8.17
8.17
0.00
0.12
0.12
0.00
(4) Direct cost (Dir)
Step 1
=(1)+(2)+(3)
16.50
85.51
17.31
17.31
0.00
7.43
7.43
0.00
(5) Direct adjustment (Dir Adj)
Steps 2-4
See footnote*
0.484
0.484
0.484
0.484
0.484
0.484
0.484
0.484
(6) Adjusted labor
Steps 2-4
=Lab * Dir Adj
=(1) * (5)
6.45
37.52
2.78
2.78
0.00
2.96
2.96
0.00
(7) Adjusted supplies
Steps 2-4
=Sup * Dir Adj
=(2) * (5)
1.44
3.55
1.64
1.64
0.00
0.58
0.58
0.00
(8) Adjusted equipment
Steps 2-4
=Eqp * Dir Adj
=(3) * (5)
0.09
0.32
3.96
3.96
0.00
0.06
0.06
0.00
(9) Adjusted direct
Steps 2-4
=(6)+(7)+(8)
7.99
41.39
8.38
8.38
0.00
3.60
3.60
0.00
(10) Conversion Factor (CF)
Step 5
PFS
36.0791
36.0791
36.0791
36.0791
36.0791
36.0791
36.0791
36.0791
(11) Adj. labor cost converted
Step 5
=(Lab * Dir Adj)/CF
=(6)/(10)
0.18
1.04
0.08
0.08
0.00
0.08
0.08
0.00
(12) Adj. supply cost converted
Step 5
=(Sup * Dir Adj)/CF
=(7)/(10)
0.04
0.10
0.05
0.05
0.00
0.02
0.02
0.00
(13) Adj. equip cost converted
Step 5
=(Eqp * Dir Adj)/CF
=(8)/(10)
0.00
0.01
0.11
0.11
0.00
0.00
0.00
0.00
(14) Adj. direct cost converted
Step 5
=(11)+(12)+(13)
0.22
1.15
0.23
0.23
0.00
0.10
0.10
0.00
(15) Wrk RVU
Setup File
PFS
0.97
33.75
0.22
0.00
0.22
0.17
0.00
0.17
(16) Dir_pct
Steps 6, 7
Surveys
25.5%
18.0%
28.9%
28.9%
28.9%
29.0%
29.0%
29.0%
(17) Ind_pct
Steps 6, 7
Surveys
74.5%
82.0%
71.2%
71.2%
71.2%
71.1%
71.1%
71.1%
(18) Ind. Alloc. formula (1st part)
Step 8
See Step 8
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
((14)/(16)) * (17)
(19) Ind. Alloc. (1st part)
Step 8
See (18)
0.65
5.23
0.57
0.57
0.00
0.24
0.24
0.00
(20) Ind. Alloc. formulas (2nd part)
Step 8
See Step 8
(15)
(15)
(15)+(11)
(11)
(15)
(15)+(11)
(11)
(15)
(21) Ind. Alloc. (2nd part)
Step 8
See (20)
0.97
33.75
0.30
0.08
0.22
0.25
0.08
0.17
(22) Indirect Allocator (1st+2nd)
Step 8
=(19)+(21)
1.62
38.98
0.87
0.65
0.22
0.50
0.33
0.17
(23) Indirect Adjustment (Ind Adj)
Steps 9-11
See footnote**
0.369
0.369
0.369
0.369
0.369
0.369
0.369
0.369
(24) Adjusted Indirect Allocator
Steps 9-11
=Ind Alloc * Ind Adj
0.60
14.37
0.32
0.24
0.08
0.18
0.12
0.06
(25) Ind.Practice Cost Index (PCI)
Steps 12-16
See Steps 12-16
1.104
0.831
0.852
0.852
0.852
0.926
0.926
0.926
(26) Adjusted Indirect
Step 17
= Adj. Ind Alloc * PCI
=(24) * (25)
0.66
11.95
0.27
0.20
0.07
0.17
0.11
0.06
(27) MEI Rebasing Adjustment
Step 18
PFS
1.168
1.168
1.168
1.168
1.168
1.168
1.168
1.168
(28) MPPR Adjustment
Step 18
PFS
1.011
1.011
1.011
1.011
1.011
1.011
1.011
1.011
(29) PE RVU
Step 18
=(Adj Dir+Adj Ind) * budn * MEI Adj * MPPR Adj
=((14)+(26)) * budn * (27) * (28)
1.03
15.36
0.59
0.51
0.08
0.32
0.25
0.07
Note:
PE RVUs in Table 2, row 27, may not match Addendum B due to rounding.
* The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [Step 2]/[Step 3].
** The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [Step 9]/[Step 10].
3. Proposed PE Revisions for CY 2011
a. Equipment Utilization Rate
As part of the PE methodology associated with the allocation of equipment costs for calculating PE RVUs, we currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment (which is equipment priced at over $1 million, for example, computed tomography (CT) and magnetic resonance imaging (MRI) scanners), for which we adopted a 90 percent utilization rate assumption and provided for a 4-year transition beginning in CY 2010 (74 FR 61755). Therefore, CY 2010 is the first transitional payment year. Payment is made in CY 2010 for the diagnostic services listed in Table 3 (those that include expensive diagnostic imaging equipment in their PE inputs) based on 25 percent of the new PE RVUs and 75 percent of the prior PE RVUs for those services.
Section 1848(b)(4)(C) of the Act (as added by section 3135(a) of the ACA) requires that with respect to fee schedules established for CY 2011 and subsequent years, in the methodology for determining PE RVUs for expensive diagnostic imaging equipment under the CY 2010 PFS final rule with comment period, the Secretary shall use a 75 percent assumption instead of the utilization rates otherwise established in that rule. The provision also requires that the reduced expenditures attributable to this change in the utilization rate for CY 2011 and subsequent years shall not be taken into account when applying the budget neutrality limitation on annual adjustments described in section 1848(c)(2)(B)(ii)(II) of the Act.
As a result, the 75 percent equipment utilization rate assumption will be applied to expensive diagnostic imaging equipment in a nonbudget neutral manner for CY 2011, and the changes to PE RVUs will not be transitioned over a period of years. We will apply the 75 percent utilization rate assumption in CY 2011 to all of the services to which we currently apply the transitional 90 percent utilization rate assumption in CY 2010. These services are listed in a file on the CMS Web site that is posted under downloads for the CY 2010 PFS final rule with comment period at: (
http://www.cms.gov/physicianfeesched/downloads/CODES_SUBJECT_TO_90PCT_USAGE_RATE.zip
). These codes are also displayed in Table 3.
Table 3—Current CPT Codes Subject to First Year (CY 2010) of 4-Year Transition to 90 Percent Equipment Utilization Rate Assumption and That Will Be Subject to the 75 Percent Equipment Utilization Rate Assumption in CY 2011
CPT code
Short descriptor
70336
Mri, temporomandibular joint(s).
70450
Ct head/brain w/o dye.
70460
Ct head/brain w/dye.
70470
Ct head/brain w/o & w/dye.
70480
Ct orbit/ear/fossa w/o dye.
70481
Ct orbit/ear/fossa w/dye.
70482
Ct orbit/ear/fossa w/o & w/dye.
70486
Ct maxillofacial w/o dye.
70487
Ct maxillofacial w/dye.
70488
Ct maxillofacial w/o & w/dye.
70490
Ct soft tissue neck w/o dye.
70491
Ct soft tissue neck w/dye.
70492
Ct soft tissue neck w/o & w/dye.
70540
Mri orbit/face/neck w/o dye.
70542
Mri orbit/face/neck w/dye.
70543
Mri orbit/face/neck w/o & w/dye.
70551
Mri brain w/o dye.
70552
Mri brain w/dye.
70553
Mri brain w/o & w/dye.
70554
Fmri brain by tech.
71250
Ct thorax w/o dye.
71260
Ct thorax w/dye.
71270
Ct thorax w/o & w/dye.
71550
Mri chest w/o dye.
71551
Mri chest w/dye.
71552
Mri chest w/o & w/dye.
72125
CT neck spine w/o dye.
72126
Ct neck spine w/dye.
72127
Ct neck spine w/o & w/dye.
72128
Ct chest spine w/o dye.
72129
Ct chest spine w/dye.
72130
Ct chest spine w/o & w/dye.
72131
Ct lumbar spine w/o dye.
72132
Ct lumbar spine w/dye.
72133
Ct lumbar spine w/o & w/dye.
72141
Mri neck spine w/o dye.
72142
Mri neck spine w/dye.
72146
Mri chest spine w/o dye.
72147
Mri chest spine w/dye.
72148
Mri lumbar spine w/o dye.
72149
Mri lumbar spine w/dye.
72156
Mri neck spine w/o & w/dye.
72157
Mri chest spine w/o & w/dye.
72158
Mri lumbar spine w/o & w/dye.
72192
Ct pelvis w/o dye.
72193
Ct pelvis w/dye.
72194
Ct pelvis w/o & w/dye.
72195
Mri pelvis w/o dye.
72196
Mri pelvis w/dye.
72197
Mri pelvis w/o & w/dye.
73200
Ct upper extremity w/o dye.
73201
Ct upper extremity w/dye.
73202
Ct upper extremity w/o & w/dye.
73218
Mri upper extr w/o dye.
73219
Mri upper extr w/dye.
73220
Mri upper extremity w/o & w/dye.
73221
Mri joint upper extr w/o dye.
73222
Mri joint upper extr w/dye.
73223
Mri joint upper extr w/o & w/dye.
73700
Ct lower extremity w/o dye.
73701
Ct lower extremity w/dye.
73702
Ct lower extremity w/o & w/dye.
73718
Mri lower extremity w/o dye.
73719
Mri lower extremity w/dye.
73720
Mri lower ext w/dye & w/o dye.
73721
Mri joint of lwr extr w/o dye.
73722
Mri joint of lwr extr w/dye.
73723
Mri joint of lwr extr w/o & w/dye.
74150
Ct abdomen w/o dye.
74160
Ct abdomen w/dye.
74170
Ct abdomen w/o & w/dye.
74181
Mri abdomen w/o dye.
74182
Mri abdomen w/dye.
74183
Mri abdomen w/o and w/dye.
74261
Ct colonography, w/o dye.
74262
Ct colonography, w/dye.
75557
Cardiac mri for morph.
75559
Cardiac mri w/stress img.
75561
Cardiac mri for morph w/dye.
75563
Cardiac mri w/stress img & dye.
75571
Ct hrt w/o dye w/ca test.
75572
Ct hrt w/3d image.
75573
Ct hrt w/3d image, congen.
77058
Mri, one breast.
77059
Mri, both breasts.
77078
Ct bone density, axial.
77084
Magnetic image, bone marrow.
Additionally, for CY 2011, we are proposing to expand the list of services to which the higher equipment utilization rate assumption applies to all other diagnostic imaging services that utilize similar expensive CT and MRI scanners. The additional 24 CPT codes (listed in Table 4) to which we are proposing to apply the 75 percent equipment utilization rate assumption also have expensive diagnostic imaging equipment (priced at over $1 million) included in their PE inputs. These services are predominantly diagnostic computed tomographic angiography (CTA) and magnetic resonance angiography (MRA) procedures that include similar expensive CT and MRI scanners in their direct PE inputs. We indicated in the CY 2010 PFS final rule with comment period (74 FR 61754) that we were persuaded by PPIS data on angiography that the extrapolation of MRI and CT data (and their higher equipment utilization rate) may be inappropriate. However, this reference was limited to those procedures that include an angiography room in the direct PE inputs, such as CPT code 93510 (Left heart catheterization, retrograde, from the brachial artery, axillary artery or femoral artery; percutaneous). In contrast, CTA and MRA procedures include a CT room or
MRI room, respectively, in the direct PE inputs, and the PPIS data confirm that a higher assumed utilization rate than 50 percent would be appropriate. The PPIS angiography room data that reflected a 56 percent equipment utilization rate would not specifically apply to CTA and MRA procedures. Thus, on further review, we believe it is appropriate to include CTA and MRA procedures in the list of procedures for which we assume a 75 percent equipment utilization rate, and we are proposing to do so beginning in CY 2011.
Consistent with section 1848(c)(2)(B)(v)(III) of the Act (as amended by section 3135 of the ACA), the reduced expenditures attributable to this change in the utilization rate assumption applicable to CY 2011 shall not be taken into account when applying the budget neutrality limitation on annual adjustments described in section 1848(c)(2)(B)(ii)(III) of the Act.
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2011 is the second year of the 4-year transition to the PE RVUs calculated using the PPIS data. The reductions in the PE RVUs for expensive diagnostic imaging equipment attributable to the change to an equipment utilization rate assumption of 75 percent for CY 2011 are not subject to the transition.
Table 4—Proposed CPT Code Additions to the 75 Percent Equipment Utilization Rate Assumption CY 2011
CPT code
Short descriptor
70496
Ct angiography, head.
70498
Ct angiography, neck.
70544
Mr angiography head w/o dye.
70545
Mr angiography head w/dye.
70546
Mr angiography head w/o & w/dye.
70547
Mr angiography neck w/o dye.
70548
Mr angiography neck w/dye.
70549
Mr angiography neck w/o & w/dye.
71275
Ct angiography, chest.
71555
Mri angio chest w/ or w/o dye.
72159
Mr angio spone w/o & w/dye.
72191
Ct angiography, pelv w/o & w/dye.
72198
Mri angio pelvis w/ or w/o dye.
73206
Ct angio upper extr w/o & w/dye.
73225
Mr angio upr extr w/o & w/dye.
73706
Ct angio lower ext w/o & w/dye.
73725
Mr angio lower ext w/ or w/o dye.
74175
Ct angiography, abdom w/o & w/dye.
74185
Mri angio, abdom w/ or w/o dye.
75565
Card mri vel flw map add-on.
75574
Ct angio hrt w/3d image.
75635
Ct angio abdominal arteries.
76380
CAT scan follow up study.
77079
Ct bone density, peripheral.
b. HCPCS Code-Specific PE Proposals
In this section, we discuss other specific CY 2011 proposals and changes related to direct PE inputs. The proposed changes that follow are included in the proposed CY 2011 direct PE database, which is available on the CMS Web site under the downloads for the CY 2011 PFS proposed rule at
http://www.cms.gov/PhysicianFeeSched/.
(1) Biohazard Bags
We have identified 22 codes for which the supply item “biohazard bag” (SM004) is currently considered a direct PE input. The item is already properly accounted for in the indirect PE because it is not attributable to an individual patient service. Therefore, we are proposing to remove the biohazard bag from the CY 2011 direct PE database and the changes in direct PE inputs for the associated services are reflected in the proposed CY 2011 direct PE database.
(2) PE Inputs for Professional Component (PC) Only and Technical Component (TC) Only Codes Summing to Global Only Codes
In the case of selected diagnostic tests, different but related CPT codes are used to describe global, professional, and technical components of a service. These codes are unlike the majority of other diagnostic test CPT codes where modifiers may be used in billing a single CPT code in order to differentiate professional and technical components. When different but related CPT codes are used to report the components of these services, the different CPT codes are referred to as “global only,” “professional (PC) only,” and “technical (TC) only” codes. Medicare payment systems are programmed to ensure that the PE RVUs for global only codes equal the sum of the PE RVUs for the PC and TC only codes. However, it has come to our attention that the direct PE inputs for certain global only codes do not reflect the appropriate summation of their related TC only and PC only component code PE inputs as they appear in the direct PE database. While the PFS payment calculations have been programmed to apply the correct PE RVUs for the global only code based on a summation of component code PE RVUs, the direct PE database has reflected incorrect inputs that are overridden by the payment system. Therefore, we are proposing to correct the direct PE inputs for the global only codes so that the inputs reflect the appropriate summing of the PE inputs for the associated PC only and TC only codes. The proposed CY 2011 direct PE database includes PE corrections to the 14 CPT codes listed in Table 5.
Table 5—Groups of Related CPT Codes With Proposed Changes to PE Inputs So That Inputs for Professional Component (PC) Only and Technical Component (TC) Only Codes Sum to Global Only Codes
CPT code
Long descriptor
93224
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage, with visual superimposition scanning; includes recording, scanning analysis with report, physician review and interpretation.
93225
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage, with visual superimposition scanning; recording (includes connection, recording, disconnection).
93226
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage, with visual superimposition scanning; scanning analysis with report.
93230
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage without superimposition scanning utilizing a device capable of producing a full miniaturized printout; including recording, microprocessor-based analysis with report, physician review and interpretation.
93231
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage without superimposition scanning utilizing a device capable of producing a full miniaturized printout; recording (includes connection, recording, and disconnection.
93232
Wearable electrocardiographic rhythm derived monitoring for 24 hours by continuous original waveform recording and storage without superimposition scanning utilizing a device capable of producing a full miniaturized printout; microprocessor-based analysis with report.
93268
Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; includes transmission, physician review and interpretation.
93270
Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; recording (includes connection, recording, and disconnection).
93271
Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; monitoring, receipt of transmissions, and analysis.
93720
Plethysmography, total body; with interpretation and report.
93721
Plethysmography, total body; tracing only, without interpretation and report.
93784
Ambulatory blood pressure monitoring, utilizing a system such as magnetic tape and/or computer disk, for 24 hours or longer; including recording, scanning analysis, interpretation and report.
93786
Ambulatory blood pressure monitoring, utilizing a system such as magnetic tape and/or computer disk, for 24 hours or longer; recording only.
93788
Ambulatory blood pressure monitoring, utilizing a system such as magnetic tape and/or computer disk, for 24 hours or longer; scanning analysis with report.
(3) Equipment Time Inputs for Certain Diagnostic Tests
We have recently identified incorrect equipment time inputs for four CPT codes associated with certain diagnostic tests (each is displayed in Table 5):
• CPT code 93225 is the TC only code that includes the connection, recording, and disconnection of the holter monitor (CMS Equipment Code EQ127) used in 24 hour continuous electrocardiographic rhythm derived monitoring. The current equipment time input for the holter monitor is 42 minutes, which parallels the intra-service clinical labor input time for the CPT code. However, the equipment time should reflect the 24 hours of continuous monitoring in which the device is used exclusively by the patient. Therefore, we are proposing to change the monitor equipment time for CPT code 93225 to 1440 minutes, the number of minutes in 24 hours.
• CPT code 93226 is the TC only code that includes the scanning analysis with report. The number of minutes the monitor (CMS Equipment Code EQ127) is used in this service should parallel the intra-service clinical labor input time of 52 minutes during which the monitor is in use, instead of the current equipment time of 1440 minutes, because this code does not represent 24 hours of device use. Therefore, we are proposing to change the monitor equipment time for CPT code 93226 to 52 minutes.
• CPT 93224 is the global only code that includes the connection, recording, and disconnection of the monitor (CMS Equipment Code EQ127) and the scanning analysis with report, as well as the physician review and interpretation. Under our proposal, its direct PE inputs have been appropriately summed to include the 1492 total minutes of time for the holter monitor that are included in CPT codes 93225 and 93226.
• CPT code 93788 is the TC only code that describes the scanning analysis with report for ambulatory blood pressure monitoring. The equipment time input for the blood pressure monitor should parallel the 10 minutes of clinical labor input for the CPT code since that is the time during which the monitor is in use. Currently, the equipment time input for the monitor is 1440 minutes, which is appropriate only for CPT code 93786, the code that describes the 24 hours of ambulatory blood pressure monitoring recording. In this case, CPT code 93786's direct PE inputs are correct. Therefore, we are proposing to correct the equipment time input for the ambulatory blood pressure monitor in CPT code 93788 to 10 minutes.
• CPT code 93784 is the global only code that includes the recording, the scanning analysis with report, and the physician interpretation and report for ambulatory blood pressure monitoring. Under our proposal, its direct PE inputs have been appropriately summed to include the 1450 total minutes of time for the ambulatory blood pressure monitor that are included in CPT codes 93786 and 93788.
We have modified the proposed CY 2011 direct PE database to reflect these changes.
(4) Cobalt-57 Flood Source
Stakeholders have requested that CMS reevaluate the useful life of the Cobalt-57 flood source (CMS Equipment Code ER001), given their estimate of approximately 271 days for the source's half-life. The current useful life input for the Colbalt-57 flood source is 5 years. Using publicly available catalogs, we found that the Cobalt-57 flood source is marketed with a useful life of 2 years. Therefore, we are proposing to change the useful life input from the current 5 years to 2 years. The Cobalt-57 flood source is included with the revised useful life input for 96 HCPCS codes in the proposed CY 2011 direct PE database.
(5) Venom Immunotherapy
One stakeholder provided updated price information for the venoms used for the five venom immunology CPT codes, specifically 95145 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); single stinging insect venom); 95146 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 2 single stinging insect venoms); 95147 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 3 single stinging insect venoms); 95148 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 4 single stinging insect venoms); 95149 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 5 single stinging insect venoms).
In the CY 2004 PFS final rule with comment period (68 FR 63206), we
adopted a pricing methodology that utilizes the average price of a 1 milliliter dose of venom and adds that price per dose as direct PE inputs for CPT codes 95145 and 95146. When a patient requires three stinging insect venoms, as for CPT code 95147, the price input for a 3-vespid mix is used. This 3-vespid mix price is also used to value CPT codes 95148 (four venoms) and 96149 (five venoms), with the single venom price added once to CPT code 97148 and twice to CPT code 97149.
As requested by the stakeholder, we are updating the price inputs for the 1-milliliter dose of venom to $16.67 and for the 3-vespid mix to $30.22 in the proposed CY 2011 direct PE database.
(6) Equipment Redundancy
Stakeholders have recently brought to our attention that the ECG, 3-channel (with SpO2, NIBP, temp, resp) (CMS Equipment Code EQ011) incorporates all of the functionality of the pulse oximeter with printer (CMS Equipment Code EQ211). Therefore, in HCPCS codes where CMS Equipment Code EQ011 is present, CMS Equipment Code EQ211 is redundant. On this basis, we are proposing to remove the pulse oximeter with printer (CMS Equipment Code EQ211) as an input for the 118 codes that also contain the ECG, 3-channel (with SpO2, NIBP, temp, resp) (CMS Equipment Code EQ011). We have made these adjustments in the proposed CY 2011 direct PE database.
(7) Equipment Duplication
We recently identified a number of CPT codes with duplicate equipment inputs in the PE database. We are proposing to remove the duplicate equipment items and have modified the proposed CY 2011 direct PE database accordingly as detailed in Table 6.
Table 6—CPT Codes With Proposed Removal of Duplicate Equipment Items in the Direct PE Database
CPT code
CMS equipment code for duplicate equipment
Description of equipment
19302 P-mastectomy w/ln removal
EF014
light, surgical.
19361 Breast reconstr w/lat flap
ED005
camera, digital system, 12 megapixel (medical grade).
EF031
table, power.
EQ168
light, exam.
44157 Colectomy w/ileoanal anast
EF031
table, power.
EQ168
light, exam.
44158 Colectomy w/neo-rectum pouch
EF031
table, power.
EQ168
light, exam.
56440 Surgery for vulva lesion
EF031
table, power.
EQ170
light, fiberoptic headlight w-source.
57296 Revise vag graft, open abd
EF031
table, power.
EQ170
light, fiberoptic headlight w-source.
58263 Vag hyst w/t/o & vag repair
EF031
table, power.
59610 Vbac delivery
EF031
table, power.
67228 Treatment of retinal lesion
EL005
lane, exam (oph).
EQ230
slit lamp (Haag-Streit), dedicated to laser use.
76813 Ob us nuchal meas, 1 gest
ED024
film processor, dry, laser.
77371 Srs, multisource
EQ211
pulse oximeter w-printer.
93540 Injection, cardiac cath
ED018
computer workstation, cardiac cath monitoring.
EL011
room, angiography.
EQ011
ECG, 3-channel (with SpO2, NIBP, temp, resp).
EQ032
IV infusion pump.
EQ088
contrast media warmer.
EQ211
pulse oximeter w-printer.
93542 Injection for heart x-rays
ED018
computer workstation, cardiac cath monitoring.
EL011
room, angiography.
EQ011
ECG, 3-channel (with SpO2, NIBP, temp, resp).
EQ032
IV infusion pump.
EQ088
contrast media warmer.
EQ211
pulse oximeter w-printer.
(8) Establishing Overall Direct PE Supply Price Inputs Based on Unit Prices and Quantities
We have identified minor errors in total price inputs for a number of supply items due to mathematical mistakes in multiplying the item unit price and the quantity used in particular CPT codes for the associated services. We are proposing to modify the direct PE database to appropriately include the overall supply price input for a supply item as the product of the unit price and the quantity of the supply item used in the CPT code. Most of the overall supply price input changes are small, and we have adjusted the proposed CY 2011 direct PE database accordingly. The CPT and Level II HCPCS codes and associated supplies for nonfacility and facility settings that are subject to these corrections are displayed in Tables 7 and 8, respectively.
Table 7—Overall Supply Price Calculation Corrections for Nonfacility Settings
CPT/HCPCS code
Short descriptor
CMS Supply code with overall price corrections
Description of supply
11952
Therapy for contour defects
SC029
needle, 18-27g.
11954
Therapy for contour defects
SC029
needle, 18-27g.
15820
Revision of lower eyelid
SA082
pack, ophthalmology visit (w-dilation).
15821
Revision of lower eyelid
SA082
pack, ophthalmology visit (w-dilation).
15822
Revision of upper eyelid
SA082
pack, ophthalmology visit (w-dilation).
17311
Mohs, 1 stage, h/n/hf/g
SG078
tape, surgical occlusive 1in (Blenderm).
17312
Mohs addl stage
SG078
tape, surgical occlusive 1in (Blenderm).
17313
Mohs, 1 stage, t/a/l
SG078
tape, surgical occlusive 1in (Blenderm).
17314
Mohs, addl stage, t/a/l
SG078
tape, surgical occlusive 1in (Blenderm).
21011
Exc face les sc < 2 cm
SH046
lidocaine 1% w-epi inj (Xylocaine w-epi).
21013
Exc face tum deep < 2 cm
SH046
lidocaine 1% w-epi inj (Xylocaine w-epi).
21073
Mnpj of tmj w/anesth
SG079
tape, surgical paper 1in (Micropore).
21076
Prepare face/oral prosthesis
SL047
dental stone powder.
21081
Prepare face/oral prosthesis
SK024
film, dental.
21310
Treatment of nose fracture
SB034
mask, surgical, with face shield.
23075
Exc shoulder les sc < 3 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
SH021
bupivacaine 0.25% inj (Marcaine).
24075
Exc arm/elbow les sc < 3 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
SH021
bupivacaine 0.25% inj (Marcaine).
25075
Exc forearm les sc < 3 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
SH021
bupivacaine 0.25% inj (Marcaine).
26115
Exc hand les sc < 1.5 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
SH021
bupivacaine 0.25% inj (Marcaine).
27327
Exc thigh/knee les sc < 3 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
27618
Exc leg/ankle tum < 3 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
28039
Exc foot/toe tum sc > 1.5 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
28043
Exc foot/toe tum sc < 1.5 cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
28045
Exc foot/toe tum deep < 1.5cm
SG056
gauze, sterile 4in x 4in (10 pack uou).
28306
Incision of metatarsal
SA048
pack, minimum multi-specialty visit.
28307
Incision of metatarsal
SA048
pack, minimum multi-specialty visit.
28310
Revision of big toe
SA048
pack, minimum multi-specialty visit.
28312
Revision of toe
SA048
pack, minimum multi-specialty visit.
28313
Repair deformity of toe
SA048
pack, minimum multi-specialty visit.
28315
Removal of sesamoid bone
SA048
pack, minimum multi-specialty visit.
28340
Resect enlarged toe tissue
SA048
pack, minimum multi-specialty visit.
28344
Repair extra toe(s)
SA048
pack, minimum multi-specialty visit.
28345
Repair webbed toe(s)
SA048
pack, minimum multi-specialty visit.
28496
Treat big toe fracture
SA048
pack, minimum multi-specialty visit.
28755
Fusion of big toe joint
SA048
pack, minimum multi-specialty visit.
28820
Amputation of toe
SA048
pack, minimum multi-specialty visit.
28890
High energy eswt, plantar f
SC051
syringe 10-12ml.
29870
Knee arthroscopy, dx
SG079
tape, surgical paper 1in (Micropore).
32553
Ins mark thor for rt perq
SB034
mask, surgical, with face shield.
36475
Endovenous rf, 1st vein
SC074
iv pressure infusor bag.
36592
Collect blood from picc
SG050
gauze, non-sterile 2in x 2in.
41530
Tongue base vol reduction
SD009
canister, suction.
41805
Removal foreign body, gum
SD134
tubing, suction, non-latex (6ft) with Yankauer tip (1).
41806
Removal foreign body, jawbone
SD134
tubing, suction, non-latex (6ft) with Yankauer tip (1).
42107
Excision lesion, mouth roof
SD009
canister, suction.
46505
Chemodenervation anal musc
SD009
canister, suction.
49411
Ins mark abd/pel for rt perq
SB034
mask, surgical, with face shield.
49440
Place gastrostomy tube perc
SK089
x-ray developer solution.
49441
Place duod/jej tube perc
SK089
x-ray developer solution.
49442
Place cecostomy tube perc
SK089
x-ray developer solution.
49446
Change g-tube to g-j perc
SK089
x-ray developer solution.
49450
Replace g/c tube perc
SK089
x-ray developer solution.
49451
Replace duod/jej tube perc
SK089
x-ray developer solution.
49452
Replace g-j tube perc
SK089
x-ray developer solution.
49460
Fix g/colon tube w/device
SK089
x-ray developer solution.
49465
Fluoro exam of g/colon tube
SK089
x-ray developer solution.
50382
Change ureter stent, percut
SB034
mask, surgical, with face shield.
50384
Remove ureter stent, percut
SB034
mask, surgical, with face shield.
50385
Change stent via transureth
SB034
mask, surgical, with face shield.
50386
Remove stent via transureth
SB034
mask, surgical, with face shield.
50387
Change ext/int ureter stent
SB034
mask, surgical, with face shield.
50389
Remove renal tube w/fluoro
SB034
mask, surgical, with face shield.
51100
Drain bladder by needle
SH047
lidocaine 1%-2% inj (Xylocaine).
51101
Drain bladder by trocar/cath
SH047
lidocaine 1%-2% inj (Xylocaine).
51727
Cystometrogram w/up
SC051
syringe 10-12ml.
51728
Cystometrogram w/vp
SC051
syringe 10-12ml.
51729
Cystometrogram w/vp&up
SC051
syringe 10-12ml.
52649
Prostate laser enucleation
SA048
pack, minimum multi-specialty visit.
53855
Insert prost urethral stent
SB024
gloves, sterile.
59300
Episiotomy or vaginal repair
SG062
packing, gauze plain 0.25-0.50in (5 yd uou).
59812
Treatment of miscarriage
SA052
pack, post-op incision care (staple).
64490
Inj paravert f jnt c/t 1 lev
SK025
film, dry, radiographic, 8in x 10in.
64493
Inj paravert f jnt l/s 1 lev
SH021
bupivacaine 0.25% inj (Marcaine).
SK025
film, dry, radiographic, 8in x 10in.
65272
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65286
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
66250
Follow-up surgery of eye
SA082
pack, ophthalmology visit (w-dilation).
67031
Laser surgery, eye strands
SA082
pack, ophthalmology visit (w-dilation).
67105
Repair detached retina
SA082
pack, ophthalmology visit (w-dilation).
67110
Repair detached retina
SA082
pack, ophthalmology visit (w-dilation).
67120
Remove eye implant material
SA082
pack, ophthalmology visit (w-dilation).
67228
Treatment of retinal lesion
SA082
pack, ophthalmology visit (w-dilation).
67901
Repair eyelid defect
SA048
pack, minimum multi-specialty visit.
75571
Ct hrt w/o dye w/ca test
SJ019
electrode adhesive disk.
75572
Ct hrt w/3d image
SJ019
electrode adhesive disk.
75573
Ct hrt w/3d image, congen
SJ019
electrode adhesive disk.
75574
Ct angio hrt w/3d image
SJ019
electrode adhesive disk.
75960
Transcath iv stent rs&i
SK034
film, x-ray 14in x 17in.
76821
Middle cerebral artery echo
SM013
disinfectant, surface (Envirocide, Sanizide).
77371
Srs, multisource
SG079
tape, surgical paper 1in (Micropore).
77372
Srs, linear based
SG079
tape, surgical paper 1in (Micropore).
77373
Sbrt delivery
SG079
tape, surgical paper 1in (Micropore).
78452
Ht muscle image spect, mult
SC051
syringe 10-12ml.
SK092
x-ray fixer solution
78454
Ht musc image, planar, mult
SK092
x-ray fixer solution.
88125
Forensic cytopathology
SL026
clearing agent (Histo-clear).
88355
Analysis, skeletal muscle
SK073
skin marking ink (tattoo).
SL061
embedding paraffin.
SL078
histology freezing spray (Freeze-It).
SL201
stain, eosin.
88356
Analysis, nerve
SB023
gloves, non-sterile, nitrile.
SK073
skin marking ink (tattoo).
SL061
embedding paraffin.
SL078
histology freezing spray (Freeze-It).
SL108
pipette.
SL201
stain, eosin.
88365
Insitu hybridization (fish)
SF004
blade, microtome.
SL179
1.0N NaOH.
SL183
slide, organosilane coated.
SL189
ethanol, 100%.
SL190
ethanol, 70%.
SL194
Hemo-De.
SM016
eye shield, splash protection.
88367
Insitu hybridization, auto
SC057
syringe 5-6ml.
SF004
blade, microtome.
SL030
cover slip, glass.
SL085
label for microscope slides.
SL178
0.2N HCL.
SL179
1.0N NaOH.
SL181
pipette tips, sterile.
SL183
slide, organosilane coated.
SL189
ethanol, 100%.
SL190
ethanol, 70%.
SL191
ethanol, 85%.
SL194
Hemo-De.
SM016
eye shield, splash protection.
88368
Insitu hybridization, manual
SF004
blade, microtome.
SL179
1.0N NaOH.
SL183
slide, organosilane coated.
SL189
ethanol, 100%.
SL190
ethanol, 70%.
SL194
Hemo-De.
SM016
eye shield, splash protection.
88385
Eval molecul probes, 51-250
SL207
air, filtered, compressed.
SL218
DNA, Versagene, blood kit.
SL220
ethanol, 200%.
SL225
gas, nitogen, ultra-high purity (compressed), grade 5.0.
88386
Eval molecul probes, 251-500
SL207
air, filtered, compressed.
SL218
DNA, Versagene, blood kit.
SL220
ethanol, 200%.
SL225
gas, nitogen, ultra-high purity (compressed), grade 5.0.
90470
Immune admin H1N1 im/nasal
SB036
paper, exam table.
91065
Breath hydrogen test
(blank)
Sivrite-4.
91132
Electrogastrography
SD062
electrode, surface.
91133
Electrogastrography w/test
SD062
electrode, surface.
92550
Tympanometry & reflex thresh
SK059
paper, recording (per sheet).
92597
Oral speech device eval
SB022
gloves, non-sterile.
92610
Evaluate swallowing function
SB022
gloves, non-sterile.
92626
Eval aud rehab status
SK008
audiology scoring forms.
92627
Eval aud status rehab add-on
SK008
audiology scoring forms.
92640
Aud brainstem implt programg
SK068
razor.
95004
Percut allergy skin tests
SC023
multi-tine device.
95024
Id allergy test, drug/bug
SA048
pack, minimum multi-specialty visit.
SG050
gauze, non-sterile 2in x 2in.
95027
Id allergy titrate-airborne
SA048
pack, minimum multi-specialty visit.
SC052
syringe 1ml.
95044
Allergy patch tests
SK087
water, distilled.
95052
Photo patch test
SK087
water, distilled.
95148
Antigen therapy services
SH009
antigen, venom.
95805
Multiple sleep latency test
SK094
x-ray marking pencil.
96040
Genetic counseling, 30 min
SK062
patient education booklet.
96102
Psycho testing by technician
SK057
paper, laser printing (each sheet).
96360
Hydration iv infusion, init
SC018
iv infusion set.
SC051
syringe 10-12ml.
SG050
gauze, non-sterile 2in x 2in.
96365
Ther/proph/diag iv inf, init
SC018
iv infusion set.
SC051
syringe 10-12ml.
SG050
gauze, non-sterile 2in x 2in.
96366
Ther/proph/diag iv inf addon
SB022
gloves, non-sterile.
96367
Tx/proph/dg addl seq iv inf
SB022
gloves, non-sterile.
96369
Sc ther infusion, up to 1 hr
SC013
infusion pump cassette-reservoir.
96371
Sc ther infusion, reset pump
SC013
infusion pump cassette-reservoir.
96372
Ther/proph/diag inj, sc/im
SB022
gloves, non-sterile.
96374
Ther/proph/diag inj, iv push
SB022
gloves, non-sterile.
SC051
syringe 10-12ml.
SG050
gauze, non-sterile 2in x 2in.
96375
Tx/pro/dx inj new drug addon
SB022
gloves, non-sterile.
SC051
syringe 10-12ml.
96401
Chemo, anti-neopl, sq/im
SC051
syringe 10-12ml.
SG050
gauze, non-sterile 2in x 2in.
96402
Chemo hormon antineopl sq/im
SC051
syringe 10-12ml.
SG050
gauze, non-sterile 2in x 2in.
96409
Chemo, iv push, sngl drug
SC018
iv infusion set 22.
SC051
syringe 10-12ml.
96411
Chemo, iv push, addl drug
SC018
iv infusion set.
SC051
syringe 10-12ml.
96413
Chemo, iv infusion, 1 hr
SC018
iv infusion set.
SC051
syringe 10-12ml.
96417
Chemo iv infus each addl seq
SC018
iv infusion set.
96445
Chemotherapy, intracavitary
SC018
iv infusion set.
SH069
sodium chloride 0.9% irrigation (500-1000ml uou).
96542
Chemotherapy injection
SC018
iv infusion set.
99366
Team conf w/pat by hc pro
SK062
patient education booklet.
G0270
MNT subs tx for change dx
SK057
paper, laser printing (each sheet).
SK062
patient education booklet.
G0271
Group MNT 2 or more 30 mins
SK057
paper, laser printing (each sheet).
Table 8—Overall Supply Price Calculation Corrections for Facility Settings
CPT/HCPCS Code
Short descriptor
CMS supply code with overall price corrections
Description of supply
15738
Muscle-skin graft, leg
SG017
bandage, Kling, non-sterile 2in.
15820
Revision of lower eyelid
SA082
pack, ophthalmology visit (w-dilation).
15821
Revision of lower eyelid
SA082
pack, ophthalmology visit (w-dilation).
15822
Revision of upper eyelid
SA082
pack, ophthalmology visit (w-dilation).
19303
Mast, simple, complete
SB006
drape, non-sterile, sheet 40in x 60in.
20900
Removal of bone for graft
SA054
pack, post-op incision care (suture).
21011
Exc face les sc < 2 cm
SA048
pack, minimum multi-specialty visit.
21013
Exc face tum deep < 2 cm
SA048
pack, minimum multi-specialty visit.
21193
Reconst lwr jaw w/o graft
SJ061
tongue depressor.
21194
Reconst lwr jaw w/graft
SJ061
tongue depressor.
21240
Reconstruction of jaw joint
SJ061
tongue depressor.
21366
Treat cheek bone fracture
SJ061
tongue depressor.
21435
Treat craniofacial fracture
SJ061
tongue depressor.
21555
Exc neck les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
21930
Exc back les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
22902
Exc abd les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
23075
Exc shoulder les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
24075
Exc arm/elbow les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
25075
Exc forearm les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
26115
Exc hand les sc < 1.5 cm
SA048
pack, minimum multi-specialty visit.
27047
Exc hip/pelvis les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
27327
Exc thigh/knee les sc < 3 cm
SA048
pack, minimum multi-specialty visit.
27618
Exc leg/ankle tum < 3 cm
SA048
pack, minimum multi-specialty visit.
28307
Incision of metatarsal
SA048
pack, minimum multi-specialty visit.
28340
Resect enlarged toe tissue
SA048
pack, minimum multi-specialty visit.
28345
Repair webbed toe(s)
SA048
pack, minimum multi-specialty visit.
28820
Amputation of toe
SA048
pack, minimum multi-specialty visit.
33516
Cabg, vein, six or more
SA052
pack, post-op incision care (staple).
34510
Transposition of vein valve
SA054
pack, post-op incision care (suture).
35013
Repair artery rupture, arm
SA048
pack, minimum multi-specialty visit.
41150
Tongue, mouth, jaw surgery
SA048
pack, minimum multi-specialty visit.
41153
Tongue, mouth, neck surgery
SA048
pack, minimum multi-specialty visit.
41155
Tongue, jaw, & neck surgery
SA048
pack, minimum multi-specialty visit.
41805
Removal foreign body, gum
SD134
tubing, suction, non-latex (6ft) with Yankauer tip (1).
41806
Removal foreign body, jawbone
SD134
tubing, suction, non-latex (6ft) with Yankauer tip (1).
42160
Treatment mouth roof lesion
SD122
suction tip, Yankauer.
51925
Hysterectomy/bladder repair
SB006
drape, non-sterile, sheet 40in x 60in.
56620
Partial removal of vulva
SA048
pack, minimum multi-specialty visit.
57284
Repair paravag defect, open
SA051
pack, pelvic exam.
SB006
drape, non-sterile, sheet 40in x 60in.
57285
Repair paravag defect, vag
SA051
pack, pelvic exam.
SB006
drape, non-sterile, sheet 40in x 60in.
57423
Repair paravag defect, lap
SA051
pack, pelvic exam.
SB006
drape, non-sterile, sheet 40in x 60in.
58660
Laparoscopy, lysis
SB006
drape, non-sterile, sheet 40in x 60in.
58662
Laparoscopy, excise lesions
SJ046
silver nitrate applicator.
58670
Laparoscopy, tubal cautery
SJ046
silver nitrate applicator.
58940
Removal of ovary(s)
SA052
pack, post-op incision care (staple).
58952
Resect ovarian malignancy
SB006
drape, non-sterile, sheet 40in x 60in.
64632
N block inj, common digit
SA048
pack, minimum multi-specialty visit.
65112
Remove eye/revise socket
SA050
pack, ophthalmology visit (no dilation).
65114
Remove eye/revise socket
SA050
pack, ophthalmology visit (no dilation).
65235
Remove foreign body from eye
SA082
pack, ophthalmology visit (w-dilation).
65265
Remove foreign body from eye
SA082
pack, ophthalmology visit (w-dilation).
65272
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65273
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65280
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65285
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65286
Repair of eye wound
SA082
pack, ophthalmology visit (w-dilation).
65290
Repair of eye socket wound
SA082
pack, ophthalmology visit (w-dilation).
65770
Revise cornea with implant
SA050
pack, ophthalmology visit (no dilation).
65850
Incision of eye
SA082
pack, ophthalmology visit (w-dilation).
65865
Incise inner eye adhesions
SA082
pack, ophthalmology visit (w-dilation).
65870
Incise inner eye adhesions
SA082
pack, ophthalmology visit (w-dilation).
66180
Implant eye shunt
SA082
pack, ophthalmology visit (w-dilation).
66185
Revise eye shunt
SA082
pack, ophthalmology visit (w-dilation).
66220
Repair eye lesion
SA082
pack, ophthalmology visit (w-dilation).
66250
Follow-up surgery of eye
SA082
pack, ophthalmology visit (w-dilation).
66500
Incision of iris
SA082
pack, ophthalmology visit (w-dilation).
66600
Remove iris and lesion
SA082
pack, ophthalmology visit (w-dilation).
66605
Removal of iris
SA082
pack, ophthalmology visit (w-dilation).
66625
Removal of iris
SA082
pack, ophthalmology visit (w-dilation).
66630
Removal of iris
SA082
pack, ophthalmology visit (w-dilation).
66635
Removal of iris
SA082
pack, ophthalmology visit (w-dilation).
66682
Repair iris & ciliary body
SA082
pack, ophthalmology visit (w-dilation).
66820
Incision, secondary cataract
SA082
pack, ophthalmology visit (w-dilation).
66850
Removal of lens material
SA082
pack, ophthalmology visit (w-dilation).
66852
Removal of lens material
SA082
pack, ophthalmology visit (w-dilation).
66930
Extraction of lens
SA082
pack, ophthalmology visit (w-dilation).
66940
Extraction of lens
SA082
pack, ophthalmology visit (w-dilation).
66983
Cataract surg w/iol, 1 stage
SA082
pack, ophthalmology visit (w-dilation).
67015
Release of eye fluid
SA082
pack, ophthalmology visit (w-dilation).
67031
Laser surgery, eye strands
SA082
pack, ophthalmology visit (w-dilation).
67036
Removal of inner eye fluid
SA082
pack, ophthalmology visit (w-dilation).
67040
Laser treatment of retina
SA082
pack, ophthalmology visit (w-dilation).
67105
Repair detached retina
SA082
pack, ophthalmology visit (w-dilation).
67107
Repair detached retina
SA082
pack, ophthalmology visit (w-dilation).
67110
Repair detached retina
SA082
pack, ophthalmology visit (w-dilation).
67115
Release encircling material
SA082
pack, ophthalmology visit (w-dilation).
67120
Remove eye implant material
SA082
pack, ophthalmology visit (w-dilation).
67228
Treatment of retinal lesion
SA082
pack, ophthalmology visit (w-dilation).
67400
Explore/biopsy eye socket
SA082
pack, ophthalmology visit (w-dilation).
67412
Explore/treat eye socket
SA082
pack, ophthalmology visit (w-dilation).
67440
Explore/drain eye socket
SA082
pack, ophthalmology visit (w-dilation).
67908
Repair eyelid defect
SG008
applicator, cotton-tipped, non-sterile 6in.
88356
Analysis, nerve
SL108
pipette.
c. AMA RUC Recommendations in CY 2010 for Changes to Direct PE Inputs
In a March 2010 letter, the AMA RUC made specific PE recommendations that we consider below. As stated earlier, the proposed changes that follow are included in the proposed CY 2011 direct PE database, which is available on the CMS Web site under the downloads for the CY 2011 PFS proposed rule at
http://www.cms.gov/PhysicianFeeSched/.
(1) Electrogastrography and Esophageal Function Test
We are accepting the AMA RUC recommendations for the CY 2011 PE inputs for the following CPT codes: 91132 (Electrogastrography, diagnostic, transcutaneous); 91133 (Electrogastrography, diagnostic, transcutaneous; with provocative testing); 91038 (Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation; prolonged (greater than 1 hour, up to 24 hours)). For CPT code 91038, we have assumed a useful life of 5 years for the equipment item “ZEPHR impedance/pH reflux monitoring system with data recorder, software, monitor, workstation and cart,” based on its entry in the AHA's publication, “Estimated Useful Lives of Depreciable Hospital Assets,” which we use as a standard reference. The proposed CY 2011 direct PE database has been changed accordingly.
(2) 64-Slice CT Scanner and Software
The AMA RUC submitted an updated recommendation regarding the correct pricing of the 64-slice CT scanner and its accompanying software. Based on the documentation accompanying the recommendation, we are accepting this recommendation and updating the price input for the 64-slice scanner and software. This affects the following four CPT codes that use either the scanner, the software, or both: 75571 (computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium); 75572 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology (including 3D image postprocessing, assessment of cardiac function, and evaluation of venous structures, if performed)); 75573 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed)); and 75574 (Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image postprocessing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structure, if performed)). The proposed CY 2011 direct PE database has been modified accordingly.
(3) Cystometrogram
The AMA RUC recently identified a rank order anomaly regarding CPT code 51726 (Complex cystometrogram (i.e., calibrated electronic equipment)). Currently, this procedure has higher PE RVUs, despite being less resource- intensive than the three CPT codes for which it serves as the base: 51727 (Complex cystometrogram
(i.e.,
calibrated electronic equipment); with urethral pressure profile studies (
i.e.,
urethral closure pressure profile), any technique); 51728 (Complex cystometrogram (
i.e.,
calibrated electronic equipment); with voiding pressure studies (
i.e.,
bladder voiding pressure), any technique); and 51729 (Complex cystometrogram (
i.e.,
calibrated electronic equipment); with voiding pressure studies (
i.e.,
bladder voiding pressure) and urethral pressure profile studies (
i.e.,
urethral closure pressure profile), any technique).
Since usual AMA RUC policy is that CPT codes with a 0-day global period do not have pre-service time associated with the code, the AMA RUC recommended removing the nonfacility pre-service clinical staff time from the PE inputs for 51726. Additionally, the AMA RUC recommended that the nonfacility clinical intra-service staff time for CPT code 51276 be reduced from the 118 minutes of intra-service clinical staff time currently assigned to the code to 85 minutes of intra-service clinical staff time. These changes would resolve the rank order anomaly and bring the PE inputs for CPT code 51726 into alignment with the other three codes. Finally, and for the reasons
stated above, the AMA RUC recommended that CMS remove the 23 minutes of pre-service nonfacility clinical staff time from CPT code 51725 (Simple cystometrogram (CMG) (
e.g.,
spinal manometer)). We are accepting these recommendations and, therefore, have changed the direct PE inputs for CPT codes 51725 and 51726 in the nonfacility setting in the proposed CY 2011 direct PE database.
(4) Breath Hydrogen Test
The AMA RUC provide recommendations regarding the PE inputs for CPT code 91065 (breath hydrogen test (
e.g.,
for detection of lactase deficiency, fructose intolerance, bacterial overgrowth, or oro-cecal gastrointestinal transit). We are accepting the recommendations with two modifications. We have folded the two pieces of equipment listed as “quinGas Table-Top Support Stand, 3 Tank” and “Drying Tube, Patient Sample” into the “BreathTrackerDigital SC Instrument” and summed their inputs into one equipment line-item, since these equipment items are used together specifically for the service in question. We have increased the useful life input of the “BreathTrackerDigital SC Instrument” from 7 to 8 years based on our use of the American Hospital Association (AHA)'s publication entitled, “Estimated Useful Lives of Depreciable Hospital Assets” as a standard reference. Additionally, because the AMA RUC did not include equipment times in their recommendations for this CPT code, we have used 53 minutes as the total time for all equipment items based on the total intra-service period for the clinical labor, consistent with our general policy for establishing equipment times. These modifications are reflected in the proposed CY 2011 direct PE database.
(5) Radiographic Fluoroscopic Room
A recent AMA RUC review of services that include the radiographic fluoroscopic room (CMS Equipment Code EL014) as a direct PE revealed that the use of the item is no longer typical for certain services in which it is specified within the current direct cost inputs. The AMA RUC recommended to CMS that the radiographic fluoroscopic room be deleted from CPT codes 64420 (Injection, anesthetic agent; intercostal nerve, single); 64421 (Injection, anesthetic agent; intercostal nerves, multiple, regional block); and 64620 (Destruction by neurolytic agent, intercostal nerve).
We are accepting these recommendations and, therefore, these changes are included in the proposed CY 2011 direct PE database.
The AMA RUC also informed us that it has convened a workgroup to examine the inclusion of the fluoroscopic room across a broader range of codes. We will consider any future recommendations from the AMA RUC on this topic when they are submitted.
d. Referral of Existing CPT Codes for AMA RUC Review
As part of our review of high cost supplies, we conducted a clinical review of the procedures associated with high cost supplies to confirm that those supplies currently are used in the typical case described by the CPT codes. While we confirmed that most high cost supplies could be used in the procedures for which they are currently direct PE inputs, we noted that one of the high cost supplies, fiducial screws (CMS Supply Code SD073) with a current price of $558, is included as a direct PE input for two CPT codes, specifically 77301 (Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications) and 77011 (Computed tomography guidance for stereotactic localization). The documentation used in the current pricing of the supply item describes a kit that includes instructions, skull screws, a drill bit, and a collar for the TALON® System manufactured by Best nomos. Best nomos' literature describes the insertion of the screws into the patient's skull to ensure accurate set-up. When CPT codes 77301 and 77011 were established in CY 2002 and CY 2003, respectively, we accepted the AMA RUC recommendations to include fiducial screws in the PE for these services. Upon further review, while we understand why this supply may be considered a typical PE input for CPT code 77011, we do not now believe that fiducial screws, as described in the Best nomos literature, would typically be used in CPT code 77301, where the most common clinical scenario would be treatment of prostate cancer.
Therefore, in order to ensure that CPT codes 77301 and 77011 are appropriately valued for CY 2011 through the inclusion or exclusion of fiducial screws in their PE, we are asking the AMA RUC to review these CPT codes with respect to the inclusion of fiducial screws in their PE. We are requesting that the AMA RUC make recommendations to us regarding whether this supply should be included in the PE or removed from the PE for CPT codes 77301 and 77011 in a timeframe that would allow us to adopt interim values for these codes for CY 2011, should the AMA RUC recommend a change. If the AMA RUC continues to recommend the inclusion of fiducial screws in the PE for CPT code 77301 and/or 77011 for CY 2011, we are requesting that the AMA RUC provide us with a detailed rationale for the inclusion of this specialized supply in the PE for the typical case reported under the relevant CPT code. We would also request that the AMA RUC furnish updated pricing information for the screws if they continue to recommend the screws as a PE input for one or both of these CPT codes in CY 2011.
e. Updating Equipment and Supply Price Inputs for Existing Codes
Historically, we have periodically received requests to change the PE price inputs for supplies and equipment in the PE database. In the past, we have considered these requests on an
ad hoc
basis and updated the price inputs as part of quarterly or annual updates if we believed them to be appropriate. In this proposed rule, we are proposing to establish a regular and more transparent process for considering public requests for changes to PE database price inputs for supplies and equipment used in existing codes.
We are proposing to act on public requests to update equipment and supply price inputs annually through rulemaking by following a regular and consistent process as discussed in the following paragraphs. We are proposing to use the annual PFS proposed rule released in the summer and the final rule released on or about November 1 each year as the vehicle for making these changes.
We will accept requests for updating the price inputs for supplies and equipment on an ongoing basis; requests must be received no later than December 31 of each CY to be considered for inclusion in the next proposed rule. In that next proposed rule, we would present our review of submitted requests to update price inputs for specific equipment or supplies and our proposals for the subsequent calendar year. We would then finalize changes in the final rule for the upcoming calendar year. Our review of the issues and consideration of public comments may result in the following outcomes that would be presented in the final rule with comment period:
• Updating the equipment or supply price inputs, as requested.
• Updating the equipment or supply price inputs, with modifications.
• Rejecting the new price inputs.
• Declining to act on the request pending a recommendation from the AMA RUC.
To facilitate our review and preparation of issues for the proposed rule, at a minimum, we would expect that requesters would provide the following information:
• Name and contact information for the requestor.
• The name of the item exactly as it appears in the direct PE file under downloads for the most recent PFS final rule with comment period, available on the CMS Web site at
http://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage
.
In order to best evaluate the requests in the context of our goal of utilizing accurate market prices for these items as direct PE inputs, we also would expect requestors to provide multiple invoices from different suppliers/manufacturers. In some cases, multiple sources may not be available, whereupon a detailed explanation should be provided to support the request. When furnishing invoices, requestors should take into consideration the following parameters:
++ May be either print or electronic but should be on supplier and/or manufacturer stationery (for example, letterhead, billing statement,
etc.
)
++ Should be for the typical, common, and customary version of the supply or equipment that is used to furnish the services.
++ Price should be net of typical rebates and/or any discounts available, including information regarding the magnitude and rationale for such rebates or discounts.
++ If multiple items are presented on the same invoice, relevant item(s) should be clearly identified.
We are soliciting public comments on this proposed process, including the information that requestors should furnish to facilitate our full analysis in preparation for the next calendar year's rulemaking cycle.
B. Malpractice Relative Value Units (RVUs)
1. Background
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 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).
2. Malpractice RVUs for New and Revised Services Effective Before the Next 5-Year Review
Currently, malpractice RVUs for new and revised codes effective before the next 5-Year Review (for example, effective CY 2011 through CY 2014) are determined by a direct crosswalk to a similar “source” code or a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust the malpractice RVUs for the new/revised code to reflect the difference in work RVUs between the source code and the AMA RUC's recommended work value (or the work value we are applying as an interim final value under the PFS) for the new code. For example, if the interim final work RVUs for the new/revised code are 10 percent higher than the work RVUs for the source code, the malpractice RVUs for the new/revised code would be increased by 10 percent over the source code RVUs. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVUs for the new/revised code to adjust for risk-of-service. The assigned malpractice RVUs for new/revised codes effective between updates remain in place until the next 5-Year Review.
We will continue our current approach for determining malpractice RVUs for new/revised codes that become effective before the next 5-Year Review and update. Under this approach we will crosswalk the new/revised code to the RVUs of a similar source code and adjust for differences in work (or, if greater, the clinical labor portion of the fully implemented PE RVUs), between the source code and the new/revised code. Additionally, we will publish a list of new/revised codes and the analytic crosswalk(s) used for determining their malpractice RVUs in the final rule with comment period, which we have not previously done. The CY 2011 malpractice RVUs for new/revised codes will be implemented as interim final values in the CY 2011 PFS final rule with comment period, where they will be subject to public comment. They will then be finalized in the CY 2012 PFS final rule with comment period.
3. Revised Malpractice RVUs for Selected Disc Arthroplasty Services
As discussed in the CY 2010 PFS proposed rule (74 FR 33539), we assign malpractice RVUs to each service based upon a weighted average of the risk factors of all specialties that furnish the service. For the CY 2010 review of malpractice RVUs, we used CY 2008 Medicare payment data on allowed services to establish the frequency of a service by specialty. CPT code 22856 (Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical) had zero allowed services for CY 2008. Therefore, our contractor initially set the level 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. We proposed to adopt our contractor's initial malpractice RVUs for CPT code 22856 in the CY 2010 proposed rule. Application of the average physician risk factor would have resulted in a significant decrease in malpractice RVUs for CPT code 22856 in CY 2010.
Several commenters on the CY 2010 PFS proposed rule expressed concern regarding the proposed malpractice RVUs for CPT code 22856, which represented a proposed reduction of more than 77 percent. The commenters stated that this service is predominantly furnished by neurosurgeons and orthopedic surgeons. Given the high risk factors associated with these specialty types and the changes in malpractice RVUs for comparable services, the commenters stated that a reduction in the malpractice RVUs of this magnitude for CPT code 22856 could not be correct.
After consideration of the public comments, for CY 2010, we set the risk factor for CPT code 22856 as the weighted average risk factor of six comparable procedures mentioned by
the commenters: CPT code 22554 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); cervical below C2); CPT code 22558 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar); CPT code 22857 (Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar); CPT code 22845 (Anterior instrumentation; 2 to 3 vertebral segments (list separately in addition to code for primary procedure)); CPT code 63075 (Discectomy, anterior, with decompression of spinal cord and/or nerve root(s), including osteophytectomy; cervical, single interspace); and CPT code 20931 (Allograft for spine surgery only; structural (list separately in addition to code for primary procedure)). The weighted average risk factor for these services is 8.4.
Since publication of the CY 2010 PFS final rule with comment period, stakeholders have mentioned that we made significant changes to the malpractice RVUs for CPT code 22856 in CY 2010. The commenters also brought to our attention that other services are clinically similar to CPT code 22856 and have similar work RVUs, and therefore, some stakeholders believe these services should all have similar malpractice RVUs. Services mentioned by the stakeholders that are clinically similar to CPT code 22856 include CPT code 22857; CPT code 22861 (Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical); CPT code 22862 (Revision including replacement of total disc arthroplasty (artificial disc) anterior approach, lumbar); CPT code 22864 (Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical); and CPT code 22865 (Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar).
After further review of this issue, we are proposi
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