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Medicare Program; Hospital Outpatient Prospective Payment System and CY 2007 Payment Rates; CY 2007 Update to the Ambulatory Surgical Center Covered Procedures List; Medicare Administrative Contractors; and Reporting Hospital Quality Data for FY 2008 Inpatient Prospective Payment System Annual Payment Update Program-HCAHPS Survey, SCIP, and Mortality

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Start Preamble Start Printed Page 67960

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule with comment period and final rule.

SUMMARY:

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system.

This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicare-approved ambulatory surgical center (ASC), which are applicable to services furnished on or after January 1, 2007.

This final rule with comment period revises the emergency medical screening requirements for critical access hospitals (CAHs).

This final rule with comment period supports implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority.

This final rule continues to implement the requirements of the DRA that require that we expand the “starter set” of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital inpatient prospective payment system (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. In this rule, we are finalizing additional quality measures for the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.

DATES:

Effective Date: The provisions of these final rules are effective on January 1, 2007.

Comment Period: We will consider comments on the payment classification assigned to HCPCS codes identified in Addendum B with the NI comment code, and other areas specified throughout the preamble, at the appropriate address, as provided below, no later than 5 p.m. January 23, 2007.

Application Deadline—New Class of New Technology Intraocular Lens: Requests for review of applications for a new class of new technology intraocular lenses must be received by close of business April 1, 2007.

ADDRESSES:

In commenting, please refer to file code CMS-1506-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (no duplicates, please):

1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/​eRulemaking. Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)

2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1506-FC, P.O. Box 8011, Baltimore, MD 21244-1850.

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 (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1506-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses: Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

(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 proof of filing by stamping in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Applications for a new class of new technology intraocular lenses: Requests for review of applications for a new class of new technology intraocular lenses must be sent by regular mail to: ASC/NTIOL, Division of Outpatient Care, Mailstop C4-05-17, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Alberta Dwivedi, (410) 786-0378, Hospital outpatient prospective payment issues.

Dana Burley, (410) 786-0378, Ambulatory surgery center issues.

Suzanne Asplen, (410) 786-4558, Partial hospitalization and community mental health centers issues. Start Printed Page 67961

Mary Collins, (410) 786-3189, Critical access hospital emergency medical planning issues.

Sandra M. Clarke, (410) 786-6975, Medicare Administrative Contractors issues.

Mark Zobel, (410) 786-6905, Medicare Administrative Contractors issues.

Liz Goldstein, (410) 786-6665, FY 2008 IPPS RHQDAPU HCAHPS issues.

Bill Lehrman, (410) 786-1037, FY 2008 IPPS RHQDAPU HCAHPS issues.

Sheila Blackstock, (410) 786-3506, FY 2008 IPPS RHQDAPU SCIP and mortality issues.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome comments from the public on the payment classification and status indicator assigned to HCPCS codes identified in Addendum B of this final rule with comment period with comment indicator NI and on the ambulatory surgical center procedures that were not proposed for addition to the ambulatory surgical center list in the CY 2007 OPPS proposed rule to assist us in fully considering issues and developing policies. You can assist us by referencing filed code CMS-1506-FC.

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.cms.hhs.gov/​eRulemaking. Click on the link “Electronic Comments on CMS Regulations” 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, MD 21244, on Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Electronic Access

This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents' home page address is http://www.gpoaccess.gov/​index.html, by using local WAIS client software, or by telnet to swais.access.gpo.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

Alphabetical List of Acronyms Appearing in the Final Rule

ACEP American College of Emergency Physicians

AHA American Hospital Association

AHIMA American Health Information Management Association

AMA American Medical Association

APC Ambulatory payment classification

AMP Average manufacturer price

ASC Ambulatory Surgical Center

ASP Average sales price

AWP Average wholesale price

BBA Balanced Budget Act of 1997, Pub. L. 105-33

BBRA Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999, Pub. L. 106-113

BCA Blue Cross Association

BCBSA Blue Cross and Blue Shield Association

BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, Pub. L. 106-554

CAH Critical access hospital

CBSA Core-Based Statistical Area

CCR Cost-to-charge ratio

CMHC Community mental health center

CMS Centers for Medicare & Medicaid Services

CNS Clinical nurse specialist

CORF Comprehensive outpatient rehabilitation facility

CPT [Physicians'] Current Procedural Terminology, Fourth Edition, 2006, copyrighted by the American Medical Association

CRNA Certified registered nurse anesthetist

CY Calendar year

DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies

DMERC Durable medical equipment regional carrier

DRA Deficit Reduction Act of 2005, Pub. L. 109-171

DSH Disproportionate share hospital

EACH Essential Access Community Hospital

E/M Evaluation and management

EPO Erythropoietin

ESRD End-stage renal disease

FACA Federal Advisory Committee Act, Pub. L. 92-463

FAR Federal Acquisition Regulations

FDA Food and Drug Administration

FFS Fee-for-service

FSS Federal Supply Schedule

FY Federal fiscal year

GAO Government Accountability Office

HCPCS Healthcare Common Procedure Coding System

HCRIS Hospital Cost Report Information System

HHA Home health agency

HIPAA Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191

ICD-9-CM International Classification of Diseases, Ninth Edition, Clinical Modification

IDE Investigational device exemption

IOL Intraocular lens

IPPS [Hospital] Inpatient prospective payment system

IVIG Intravenous immune globulin

MAC Medicare Administrative Contractors

MedPAC Medicare Payment Advisory Commission

MDH Medicare-dependent, small rural hospital

MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. 108-173

MPFS Medicare Physician Fee Schedule

MSA Metropolitan Statistical Area

NCCI National Correct Coding Initiative

NCD National Coverage Determination

NTIOL New technology intraocular lens

OCE Outpatient Code Editor

OMB Office of Management and Budget

OPD [Hospital] Outpatient department

OPPS [Hospital] Outpatient prospective payment system

PHP Partial hospitalization program

PM Program memorandum

PPI Producer Price Index

PPS Prospective payment system

PPV Pneumococcal pneumonia (virus)

PRA Paperwork Reduction Act

QIO Quality Improvement Organization

RFA Regulatory Flexibility Act

RHQDAPU Reporting hospital quality data for annual payment update

RHHI Regional home health intermediary

SBA Small Business Administration

SCH Sole community hospital

SDP Single Drug Pricer

SI Status indicator

TEFRA Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. 97-248

TOPS Transitional outpatient payments

USPDI United States Pharmacopoeia Drug Information

Start Printed Page 67962

In this document, we address three payment systems under the Medicare program: the hospital outpatient prospective payment system (OPPS), the hospital inpatient prospective payment system (IPPS), and the ambulatory surgical center (ASC) payment system. The provisions relating to the OPPS are included in sections I. through XIII., XV., XVI., XIX., XXIII., XXIV., XXV., and XXVI. of the preamble and in Addenda A, B, C (Addendum C is available on the Internet only; see section XXIII. of the preamble of this final rule with comment period), D1, D2, and E of this final rule with comment period. The provisions related to the IPPS are included in sections XXII. and XXVI.E. of the preamble. The provisions related to ASCs are included in sections XVII. and XXV., and XXVI.C. of the preamble and in Addenda AA of this final rule with comment period.

In addition, in this document, we address our implementation of the Medicare contracting reform provisions of the MMA that replace the prior Medicare intermediary and carrier authorities formerly found in sections 1816 and 1842 of the Act with Medicare administrative contractor (MAC) authority under a new section 1874A of the Act. The provisions relating to MACs are included in sections XVIII. and XXV.D. of this preamble. To assist readers in referencing sections contained in this document, we are providing the following table of contents:

Table of Contents

I. Background for the OPPS

A. Legislative and Regulatory Authority for the Hospital Outpatient Prospective Payment System

B. Excluded OPPS Services and Hospitals

C. Prior Rulemaking

D. APC Advisory Panel

1. Authority of the APC Panel

2. Establishment of the APC Panel

3. APC Panel Meetings and Organizational Structure

E. Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

1. Reduction in Threshold for Separate APCs for Drugs

2. Special Payment for Brachytherapy

F. Provisions of the Deficit Reduction Act (DRA) of 2005

1. 3-Year Transition of Hold Harmless Payments

2. Medicare Coverage of Ultrasound Screening for Abdominal Aortic Aneurysms

3. Colorectal Cancer Screening

G. Summary of the Provisions of the CY 2007 OPPS Proposed Rule

1. Updates to the OPPS Payments for CY 2007

2. Ambulatory Payment Classification (APC) Group Policies

3. Payment Changes for Devices

4. Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals

5. Estimate of Transitional Pass-Through Spending in CY 2007 for Drugs, Biologicals, and Devices

6. Brachytherapy Payment Changes

7. Coding and Payment for Drugs Administration

8. Hospital Coding and Payments for Visits

9. Payment for Blood and Blood Products

10. Payment for Observation Services

11. Procedures That Will Be Paid Only as Inpatient Services

12. Nonrecurring Policy Changes

13. Emergency Medical Screening in Critical Access Hospitals (CAHs)

14. Payment Status and Comment Indicator Assignments

15. OPPS Policy and Payment Recommendations

16. Policies Affecting Ambulatory Surgical Centers (ASCs) for CY 2007

17. Revised ASC Payment System for Implementation January 1, 2008

18. Medicare Contracting Reform Mandate

19. Reporting Quality Data for Improved Quality and Costs Under the OPPS

20. Promoting Effective Use of Health Information Technology

21. Health Care Information Transparency Initiative

22. Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for FY 2008 IPPS Annual Payment Update

23. Impact Analysis

H. Public Comments Received in Response to the CY 2007 OPPS and Reporting Hospital Quality Data for FY 2008 IPPS Annual Payment Update Program—HCAHPS Survey, SCIP, and Mortality Proposed Rules

I. Public Comments Received on the November 10, 2005 OPPS Final Rule with Comment Period

II. Updates Affecting OPPS Payments for CY 2007

A. Recalibration of APC Relative Weights for CY 2007

1. Database Construction

a. Database Source and Methodology

b. Use of Single and Multiple Procedure Claims

c. Revised Overall Cost-to-Charge Ratio (CCR) Calculation

2. Calculation of Median Costs for CY 2007

3. Calculation of Scaled OPPS Payment Weights

4. Changes to Packaged Services

B. Payment for Partial Hospitalization

1. Background

2. PHP APC Update for CY 2007

3. Separate Threshold for Outlier Payments to CMHCs

C. Conversion Factor Update for CY 2007

D. Wage Index Changes for CY 2007

E. Statewide Average Default CCRs

F. OPPS Payments to Certain Rural Hospitals

1. Hold Harmless Transitional Payment Changes Made by Pub. L. 109-171 (DRA)

2. Adjustment for Rural SCHs Implemented in CY 2006 Related to Pub. L. 108-173 (MMA)

G. CY 2007 Hospital Outpatient Outlier Payments

1. CY 2007 Proposal

2. CY 2007 Final Rule Outlier Calculation

H. Calculation of the OPPS National Unadjusted Medicare Payment

I. Beneficiary Copayments for CY 2007

1. Background

2. Copayment for CY 2007

3. Calculation of an Adjusted Copayment Amount for an APC Group for CY 2007

III. OPPS Ambulatory Payment Classification (APC) Group Policies

A. Treatment of New HCPCS and CPT Codes

1. Treatment of New HCPCS Codes Included in the Second and Third Quarterly OPPS Updates for CY 2006

2. Treatment of New CY 2007 Category I and III CPT Codes and Level II HCPCS Codes

3. Treatment of New Mid-Year CPT Codes

B. Variations Within APCs

1. Background

2. Application of the 2 Times Rule

3. Exceptions to the 2 Times Rule

C. New Technology APCs

1. Introduction

2. Movement of Procedures from New Technology APCs to Clinical APCs

a. Nonmyocardial Positron Emission Tomography (PET) Scans (APC 0308)

b. PET/Computed Tomography (CT) Scans (APC 0308)

c. Stereotactic Radiosurgery (SRS) Treatment Delivery Services (APCs 0065, 0066, and 0067)

d. Magnetoencephalography (MEG) Services (APCs 0038 and 0209)

e. Other Services in New Technology APCs

(1) Breast Brachytherapy (APCs 0029 and 0030)

(2) Radiofrequency Ablation (APCs 0050 and 0423)

(3) Extracorporeal Shock Wave Treatment (APC 0050)

(4) Insertion of Venuous Access Device with Two Ports (APC 0623)

(5) Stereoscopic X-Ray Guidance (APC 0257)

(6) Whole Body Tumor Imaging (APC 0408)

(7) Gastroesophageal Reflux Test With pH Electrode (APC 0361)

(8) Home International Normalized Ratio (INR) Monitoring (APC 0604)

(9) Tositumomab Administration and Supply (APC 0442)

(10) Summary of Other New Technology Procedures Assigned to Clinical APCs for CY 2007

D. APC-Specific Policies

1. Radiology Procedures

a. Radiology Procedures (APCs 0333, 0662, and Other Imaging APCs)

b. Computerized Reconstruction (APC 0417)

c. Cardiac Computed Tomography and Computed Tomographic Angiography (APCs 0282, 0376, 0377, and 0398)

d. Radiologic Evaluation of Central Venous Access Device (APC 0340)

2. Nuclear Medicine and Radiation Oncology Procedures

a. Myocardial Positron Emission Tomography (PET) Scans (APC 0307)

b. Complex Interstitial Radiation Source Application (APC 0651)

c. Proton Beam Therapy (APCs 0664 and 0667) Start Printed Page 67963

d. Urinary Bladder Residual Study (APC 0340)

e. Hyperthermia Treatment (APC 0314)

f. Unlisted Procedure for Clinical Brachytherpy (APC 0312)

3. Cardiac and Vascular Procedures

a. Electrophysiologic Recording/Mapping (APC 0087)

b. Endovenous Laser Ablation Procedures (APC 0092)

c. Repair/Repositioning of Defibrillator Leads (APC 0106)

d. Thrombectomy Procedures (APCs 0103 and 0653)

4. Gastrointestinal and Genitourinary Procedures

a. Insertion of Mesh or Other Prosthesis (APC 0195)

b. Percutaneous Renal Cryoablation (APC 0423)

c. Ultrasound Ablation of Uterine Fibroids with Magnetic Resonance Guidance (MRgFUS) (APCs 0195 and 0202)

d. Laser Vaporization of Prostate (APC 0429)

e. Gastrointestinal Procedures with Stents (APC 0384)

f. Endoscopy with Thermal Energy to Sphincter (APC 0422)

5. Ocular Procedures

a. Keratoprosthesis (APC 0293)

b. Eye Procedures (APCs 0232, 0235, and 0241)

c. Amniotic Membrane for Ocular Surface Reconstruction

6. Other Procedures

a. Skin Replacement Surgery and Skin Substitutes (APC 0025)

b. Treatment of Fracture/Dislocation (APCs 0062, 0063, and 0064)

c. Complex Skin Repair (APC 0024)

d. Insertion of Posterior Spinous Process Distraction Device

7. Medical Services

a. Medication Therapy Management Services

b. Single Allergy Tests (APC 0381)

c. Hyperbaric Oxygen Therapy (APC 0659)

d. Guidance for Chemodenervation (APC 0215)

e. Pathology Services (APC 0344)

IV. OPPS Payment Changes for Devices

A. Treatment of Device-Dependent APCs

1. Background

2. CY 2007 Payment Policy

3. Devices Billed in the Absence of an Appropriate Procedure Code

4. Payment Policy When Devices are Replaced Without Cost or Where Credit for a Replaced Device is Furnished to the Hospital

B. Pass-Through Payments for Devices

1. Expiration of Transitional Pass-Through Payments for Certain Devices

a. Background

b. Policy for CY 2007

2. Provisions for Reducing Transitional Pass-Through Payments to Offset Costs Packaged into APC Groups

a. Background

b. Policies for CY 2007

V. OPPS Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals

A. Transitional Pass-Through Payment for Additional Costs of Drugs and Biologicals

1. Background

2. Drugs and Biologicals With Expiring Pass-Through Status in CY 2006

3. Drugs and Biologicals With Pass-Through Status in CY 2007

B. Payment for Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status

1. Background

2. Criteria for Packaging Payment for Drugs, Biologicals, and Radiopharmaceuticals

3. Payment for Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Status That Are Not Packaged

a. Payment for Specified Covered Outpatient Drugs

(1) Background

(2) Payment Policy for CY 2007

(3) CY 2007 Payment Policy for Radiopharmaceuticals

(a) Background and Proposed CY 2007 Radiopharmaceutical Payment Policy

(b) CY 2007 Final Radiopharmaceutical Payment Policy

b. CY 2007 Payment for Nonpass-Through Drugs, Biologicals, Radiopharmaceuticals With HCPCS Codes, But Without OPPS Hospital Claims Data

(1) Background

(2) CY 2007 Proposed and Final Payment Policy for Radiopharmaceuticals With HCPCS Codes, But Without Hospital Claims Data

(3) CY 2007 Proposed and Final Payment Policy for Drugs and Biologicals With HCPCS Codes, But Without OPPS Hospital Claims Data

(4) CY 2007 Proposed and Final Payment Policy for Drugs, Biologicals, and Radiopharmaceuticals With HCPCS Codes, But Without OPPS Hospital Claims Data and Without ASP-Related Data

VI. Estimate of OPPS Transitional Pass-Through Spending in CY 2007 for Drugs, Biologicals, Radiopharmaceuticals, and Devices

A. Total Allowed Pass-Through Spending

B. Estimate of Pass-Through Spending for CY 2007

VII. Brachytherapy Source Payment Changes

A. Background

B. Government Accountability Office's Final Report on Devices of Brachytherapy

C. Payments for Brachytherapy Sources in CY 2007

VIII. Changes to OPPS Drug Administration Coding and Payment for CY 2007

A. Background

B. CY 2007 Drug Administration Coding Changes

C. CY 2007 Drug Administration Payment Changes

IX. Hospital Coding and Payment for Visits

A. Background

1. Guidelines Based on the Number or Type of Staff Interventions

2. Guidelines Based on the Time Staff Spent with the Patient

3. Guidelines Based on a Point System Where a Certain Number of Points Are Assigned to Each Staff Intervention Based on the Time, Intensity, and Staff Type Required for the Intervention

4. Guidelines Based on Patient Complexity

B. CY 2007 Proposed and Final Coding Policies

1. Clinic Visits

2. Emergency Department Visits

3. Critical Care Services

C. CY 2007 Payment Policy

D. CY 2007 Treatment of Guidelines

1. Background

2. Outstanding Concerns with the AHA/AHIMA Guidelines

a. Three Versus Five Levels of Codes

b. Lack of Clarity for Some Interventions

c. Treatment of Separately Payable Services

d. Some Interventions Appear Overvalued

e. Concerns of Specialty Clinics

f. American with Disabilities Act

g. Differentiation Between New and Established Patients and Between Standard Visits and Consultations

h. Distinction Between Type A and Type B Emergency Departments

X. Payment for Blood and Blood Products

A. Background

B. Policy Changes for CY 2007

XI. OPPS Payment for Observation Services

XII. Procedures That Will be Paid Only as Inpatient Procedures

A. Background

B. Changes to the Inpatient List

C. CY 2007 Payment for Ancillary Outpatient Services When Patient Expires (-CA Modifier)

1. Background

2. Policy for CY 2007

XIII. Nonrecurring Policy Changes

A. Removal of Comprehensive Outpatient Rehabilitation Facility (CORF) Services from the List of Services Paid under the OPPS

B. Addition of Ultrasound Screening for Abdominal Aortic Aneurysms (AAAs) (Section 5112 of Pub. L. 109-171 (DRA))

1. Background

2. Assignment of New HCPCS Code and Payment for Ultrasound Screening for Abdominal Aortic Aneurysm (AAA)

XIV. Emergency Medical Screening in Critical Access Hospitals (CAHs)

A. Background

B. Proposed Policy Change

C. Public Comments Received on the Proposal

D. Final Policy

XV. OPPS Payment Status and Comment Indicators

A. CY 2007 Status Indicator Definitions

1. Payment Status Indicators to Designate Services That Are Paid under the OPPS

2. Payment Status Indicators to Designate Services That Are Paid under a Payment System Other Than the OPPS

3. Payment Status Indicators to Designate Services That Are Not Recognized under the OPPS But That May Be Recognized by Other Institutional Providers

4. Payment Status Indicators to Designate Services That Are Not Payable by Medicare

B. CY 2007 Comment Indicator Definitions

XVI. OPPS Policy and Payment Recommendations

A. MedPAC Recommendations

B. APC Panel Recommendations

C. GAO Recommendations

XVII. Policies Affecting Ambulatory Surgical Centers (ASCs) for CY 2007 Start Printed Page 67964

A. ASC Background

1. Legislative History

2. Current Payment Method

3. Published Changes to the ASC List

B. ASC List Update Effective for Services Furnished On or After January 1, 2007

1. Criteria for Additions To or Deletions From the ASC List

2. Rationale for Payment Assignment

3. Response to Comments to the May 4, 2005 Interim Final Rule for the ASC Update

4. Procedures Proposed for Additions to the ASC List

5. Specific Requests for Payment Group Changes

6. Requests for Additions to the ASC List from Comments to the August 23, 2006 Proposed Rule

a. Requests Accepted for Additions to the ASC List for CY 2007

b. Requests Not Accepted for Additions to the ASC List for CY 2007

7. Requests for Payment Increases for Procedures on the Current ASC List

8. Other Comments on the May 4, 2005 Interim Final Rule

C. Regulatory Changes for CY 2007

D. Implementation of Section 1834(d) of the Act

E. Implementation of Section 5103 of Pub. L. 109-171 (DRA)

F. Modification of the Current ASC Process for Adjusting Payment for New Technology Intraocular Lenses (NTIOLs)

1. Background

a. Current ASC Payment for Insertion of IOLs

b. Classes of NTIOLs Approved for Payment Adjustment

2. Proposed and Final Changes

a. Process for Recognizing IOLs as Belonging to an Active IOL Class

b. Public Notice and Comment Regarding Adjustments of NTIOL Payment Amounts

c. Factors CMS Considers in Determining Whether an Adjustment of Payment for Insertion of a New Class of NTIOL is Appropriate

d. Revision of the Content of a Request to Review

e. Notice of CMS Determination

f. Payment Adjustment

G. Announcement of CY 2007 Deadline for Submitting Requests for CMS Review of Appropriateness of ASC Payment for Insertion Following Cataract Surgery of an NTIOL

XVIII. Medicare Contracting Reform Mandate

A. Background

B. CMS's Vision for Medicare Fee-for-Service and Medicare Administrative Contractors (MAC)

C. Provider Nomination and the Former Medicare Acquisition Authorities

D. Summary of Changes Made to Section 1816 of the Act

E. Provisions of the Proposed and Final Regulations

1. Definitions

2. Assignments of Providers and Suppliers to MACs

3. Other Technical and Conforming Changes

a. Definition of “Intermediary”

b. Intermediary Functions

c. Options Available to Providers and CMS

d. Nomination for Intermediary

e. Notification of Actions on Nominations, Changes to Another Intermediary or to Direct Payment, and Requirements for Approval of an Agreement

f. Considerations Relating to the Effective and Efficient Administration of the Medicare Program

g. Assignment and Reassignment of Providers by CMS

h. Designation of National or Regional Intermediaries and Designation of Regional and Alternative Designated Regional Intermediaries for Home Health Agencies and Hospices

i. Awarding of Experimental Contracts

XIX. Reporting Quality Data for Improved Quality and Costs under the OPPS

XX. Promoting Effective Use of Health Information Technology

XXI. Health Care Information Transparency Initiative

XXII. Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for the FY 2008 IPPS Annual Payment Update

A. Background

B. Additional Quality Measures for FY 2008

1. Introduction

2. HCAHPS Survey and the Hospital Quality Initiative

3. Surgical Care Improvement Project (SCIP) Quality Measures

4. Mortality Outcome Measures

C. General Procedures and Participation Requirements for the FY 2008 IPPS RHQDAPU Program

D. HCAHPS Procedures and Participation Requirements for the FY 2008 IPPS RHQDAPU Program

1. Introduction

2. HCAHPS Hospital Pledge and Beginning Date for Data Collection

3. HCAHPS Dry Run

4. HCAHPS Data Collection Requirements

5. HCAHPS Registration Requirements

6. Additional Steps for HCAHPS Participation

7. HCAHPS Survey Completion Requirements

8. HCAHPS Public Reporting

9. Reporting HCAHPS Results for Multi-Campus Hospitals

E. SCIP & Mortality Measure Requirements for the FY 2008 RHQDAPU Program

F. Conclusion

XXIII. Files Available to the Public Via the Internet

XXIV. Collection of Information Requirements

XXV. Response to Comments

XXVI. Regulatory Impact Analysis

A. Overall Impact

1. Executive Order 12866

2. Regulatory Flexibility Act (RFA)

3. Small Rural Hospitals

4. Unfunded Mandates

5. Federalism

B. Effects of OPPS Changes in This Final Rule with Comment Period

1. Alternatives Considered

a. Alternatives Considered for Coding and Payment Policy for Visits

b. Alternatives Considered for Brachytherapy Source Payments

c. Alternatives Considered for Payment of Radiopharmaceuticals

2. Limitation of Our Analysis

3. Estimated Impact of This Final Rule with Comment Period on Hospitals

4. Estimated Effect of This Final Rule with Comment Period on Beneficiaries

5. Conclusion

6. Accounting Statement

C. Effects of Changes to the ASC Payment System for CY 2007

1. Alternatives Considered

2. Limitations on Our Analysis

3. Estimated Effects of This Final Rule with Comment Period on ASCs

4. Estimated Effects of This Final Rule with Comment Period on Beneficiaries

5. Conclusion

6. Accounting Statement

D. Effects of the Medicare Contracting Reform Mandate

E. Effects of Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for IPPS FY 2008

1. Alternatives Considered

2. Estimated Effects of This Final Rule with Comment Period

a. Effects on Hospitals

b. Effects on Other Providers

c. Effects on the Medicare and Medicaid Program

F. Executive Order 12866

Regulation Text

Addenda

Addendum A—OPPS List of Ambulatory Payment Classification (APCs) with Status Indicators (SI), Relative Weights, Payment Rates, and Copayment Amounts—CY 2007

Addendum AA—List of Medicare Approved ASC Procedures for CY 2007 With Additions and Payment Rates; Including Rates That Result From Implementation of Section 5103 of the DRA

Addendum B—OPPS Payment Status By HCPCS Code and Related Information CY 2007

Addendum D1—Payment Status Indicators

Addendum D2—Comment Indicators

Addendum E—CPT Codes That Are Paid Only As Inpatient Procedures

Addendum L—Out-Migration Adjustment

I. Background for the OPPS

A. Legislative and Regulatory Authority for the Hospital Outpatient Prospective Payment System

When the Medicare statute was originally enacted, Medicare payment for hospital outpatient services was based on hospital-specific costs. In an effort to ensure that Medicare and its beneficiaries pay appropriately for services and to encourage more efficient delivery of care, the Congress mandated replacement of the reasonable cost-based payment methodology with a prospective payment system (PPS). The Balanced Budget Act (BBA) of 1997 (Pub. L. 105-33), added section 1833(t) Start Printed Page 67965to the Social Security Act (the Act) authorizing implementation of a PPS for hospital outpatient services (OPPS).

The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act (BBRA) of 1999 (Pub. L. 106-113), made major changes in the hospital OPPS. The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000 (Pub. L. 106-554), made further changes in the OPPS. Section 1833(t) of the Act was also amended by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108-173). The Deficit Reduction Act (DRA) of 2005 (Pub. L. 109-171), enacted on February 8, 2006, made additional changes in the OPPS. A discussion of the provisions contained in Pub. L. 109-171 that are specific to the calendar year (CY) 2007 OPPS is included in section II.F. of this preamble.

The OPPS was first implemented for services furnished on or after August 1, 2000. Implementing regulations for the OPPS are located at 42 CFR Part 419.

Under the OPPS, we pay for hospital outpatient services on a rate-per-service basis that varies according to the ambulatory payment classification (APC) group to which the service is assigned. We use Healthcare Common Procedure Coding System (HCPCS) codes (which include certain Current Procedural Terminology (CPT) codes) and descriptors to identify and group the services within each APC group. The OPPS includes payment for most hospital outpatient services, except those identified in section I.B. of this preamble. Section 1833(t)(1)(B)(ii) of the Act provides for Medicare payment under the OPPS for hospital outpatient services designated by the Secretary (which includes partial hospitalization services furnished by community mental health centers (CMHCs)) and hospital outpatient services that are furnished to inpatients who have exhausted their Part A benefits or who are otherwise not in a covered Part A stay. Section 611 of Pub. L. 108-173 added provisions for Medicare coverage of an initial preventive physical examination, subject to the applicable deductible and coinsurance, as an outpatient department service, payable under the OPPS.

The OPPS rate is an unadjusted national payment amount that includes the Medicare payment and the beneficiary copayment. This rate is divided into a labor-related amount and a nonlabor-related amount. The labor-related amount is adjusted for area wage differences using the inpatient hospital wage index value for the locality in which the hospital or CMHC is located.

All services and items within an APC group are comparable clinically and with respect to resource use (section 1833(t)(2)(B) of the Act). In accordance with section 1833(t)(2) of the Act, subject to certain exceptions, services and items within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the APC group is more than 2 times greater than the lowest median cost for an item or service within the same APC group (referred to as the “2 times rule”). In implementing this provision, we use the median cost of the item or service assigned to an APC group.

Special payments under the OPPS may be made for new technology items and services in one of two ways. Section 1833(t)(6) of the Act provides for temporary additional payments which we refer to as “transitional pass-through payments” for at least 2 but not more than 3 years for certain drugs, biological agents, brachytherapy devices used for the treatment of cancer, and categories of other medical devices. For new technology services that are not eligible for transitional pass-through payments and for which we lack sufficient data to appropriately assign them to a clinical APC group, we have established special APC groups based on costs, which we refer to as new technology APCs. These new technology APCs are designated by cost bands which allow us to provide appropriate and consistent payment for designated new procedures that are not yet reflected in our claims data. Similar to pass-through payments, an assignment to a new technology APC is temporary; that is, we retain a service within a new technology APC until we acquire sufficient data to assign it to a clinically appropriate APC group.

B. Excluded OPPS Services and Hospitals

Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to designate the hospital outpatient services that are paid under the OPPS. While most hospital outpatient services are payable under the OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for ambulance, physical and occupational therapy, and speech-language pathology services, for which payment is made under a fee schedule. Section 614 of Pub. L. 108-173 amended section 1833(t)(1)(B)(iv) of the Act to exclude OPPS payment for screening and diagnostic mammography services. The Secretary exercised the authority granted under the statute to exclude from the OPPS those services that are paid under fee schedules or other payment systems. Such excluded services include, for example, the professional services of physicians and nonphysician practitioners paid under the Medicare Physician Fee Schedule (MPFS); laboratory services paid under the clinical diagnostic laboratory fee schedule; services for beneficiaries with end-stage renal disease (ESRD) that are paid under the ESRD composite rate; and, services and procedures that require an inpatient stay that are paid under the hospital inpatient prospective payment system (IPPS). We set forth the services that are excluded from payment under the OPPS in § 419.22 of the regulations.

Under § 419.20(b) of the regulations, we specify the types of hospitals and entities that are excluded from payment under the OPPS. These excluded entities include Maryland hospitals, but only for services that are paid under a cost containment waiver in accordance with section 1814(b)(3) of the Act; critical access hospitals (CAHs); hospitals located outside of the 50 States, the District of Columbia, and Puerto Rico; and Indian Health Service hospitals.

C. Prior Rulemaking

On April 7, 2000, we published in the Federal Register a final rule with comment period (65 FR 18434) to implement a prospective payment system for hospital outpatient services. The hospital OPPS was first implemented for services furnished on or after August 1, 2000. Section 1833(t)(9) of the Act requires the Secretary to review certain components of the OPPS not less often than annually and to revise the groups, relative payment weights, and other adjustments to take into account changes in medical practice, changes in technology, and the addition of new services, new cost data, and other relevant information and factors.

Since initially implementing the OPPS, we have published final rules in the Federal Register annually to implement statutory requirements and changes arising from our experience with this system. We last published such a document on November 10, 2005 (70 FR 68516). In that final rule with comment period, we revised the OPPS to update the payment weights and conversion factor for services payable under the CY 2006 OPPS on the basis of claims data from January 1, 2004, through December 31, 2004, and to implement certain provisions of Pub. L. 108-173. In addition, we responded to public comments received on the provisions of November 15, 2004 final rule with comment period pertaining to Start Printed Page 67966the APC assignment of HCPCS codes identified in Addendum B of that rule with the new interim (NI) comment indicators; and public comments received on the July 25, 2005 OPPS proposed rule for CY 2006 (70 FR 42674).

We published a correction of the November 10, 2005 final rule with comment period on December 23, 2005 (70 FR 76176). This correction document corrected a number of technical errors that appeared in the November 10, 2005 final rule with comment period.

D. APC Advisory Panel

1. Authority of the APC Panel

Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of the BBRA, requires that we consult with an outside panel of experts to review the clinical integrity of the payment groups and their weights under the OPPS. The Act further specifies that the panel will act in an advisory capacity. The Advisory Panel on Ambulatory Payment Classification (APC) Groups (the APC Panel), discussed under section I.D.2. of this preamble, fulfills these requirements. The APC Panel is not restricted to using data compiled by CMS and may use data collected or developed by organizations outside the Department in conducting its review.

2. Establishment of the APC Panel

On November 21, 2000, the Secretary signed the initial charter establishing the APC Panel. This expert panel, which may be composed of up to 15 representatives of providers subject to the OPPS (currently employed full-time, not as consultants, in their respective areas of expertise), reviews and advises CMS about the clinical integrity of the APC groups and their weights. For purposes of this Panel, consultants or independent contractors are not considered to be full-time employees. The APC Panel is technical in nature and is governed by the provisions of the Federal Advisory Committee Act (FACA). Since its initial chartering, the Secretary has twice renewed the APC Panel's charter: on November 1, 2002, and on November 1, 2004. The current charter indicates, among other requirements, that the APC Panel continues to be technical in nature; is governed by the provisions of the FACA; may convene up to three meetings per year; has a Designated Federal Officer (DFO); and is chaired by a Federal official who also serves as a CMS medical officer.

The current APC Panel membership and other information pertaining to the Panel, including its charter, Federal Register notices, meeting dates, agenda topics, and meeting reports can be viewed on the CMS Web site at http://www.cms.hhs.gov/​FACA/​ 05AdvisoryPanelonAmbulatory PaymentClassification Groups.as#TopOFPage.

3. APC Panel Meetings and Organizational Structure

The APC Panel first met on February 27, February 28, and March 1, 2001. Since that initial meeting, the APC Panel has held 10 subsequent meetings, with the last meeting taking place on August 23 and 24, 2006. (The APC Panel did not meet on August 25, 2006, as announced in the meeting notice published on June 23, 2006 (71 FR 36118).) Prior to each meeting, we publish a notice in the Federal Register to announce the meeting and, when necessary, to solicit and announce nominations for APC Panel membership.

The APC Panel has established an operational structure that, in part, includes the use of three subcommittees to facilitate its required APC review process. The three current subcommittees are the Data Subcommittee, the Observation Subcommittee, and the Packaging Subcommittee. The Data Subcommittee is responsible for studying the data issues confronting the APC Panel and for recommending options for resolving them. The Observation Subcommittee reviews and makes recommendations to the APC Panel on all issues pertaining to observation services paid under the OPPS, such as coding and operational issues. The Packaging Subcommittee studies and makes recommendations on issues pertaining to services that are not separately payable under the OPPS, but are bundled or packaged APC payments. Each of these subcommittees was established by a majority vote of the APC Panel during a scheduled APC Panel meeting and their continuation as subcommittees was approved at the August 2006 APC Panel meeting. All subcommittee recommendations are discussed and voted upon by the full APC Panel.

Discussions of the recommendations resulting from the APC Panel's March 2006 and August 2006 meetings are included in the sections of this preamble that are specific to each recommendation. For discussions of earlier APC Panel meetings and recommendations, we reference previous hospital OPPS final rules or the Web site mentioned earlier in this section.

E. Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, Pub. L. 108-173, made changes to the Act relating to the Medicare OPPS. In the January 6, 2004 interim final rule with comment period and the November 15, 2004 final rule with comment period, we implemented provisions of Pub. L. 108-173 relating to the OPPS that were effective for services provided in CY 2004 and CY 2005, respectively. In the November 10, 2005 final rule with comment period, we implemented provisions of Pub. L. 108-173 relating to the OPPS that went into effect for services provided in CY 2006 (70 FR 68521). We note below those provision of Pub. L. 108-173 that will expire at the end of CY 2006.

1. Reduction in Threshold for Separate APCs for Drugs

Section 621(a)(2) of Pub. L. 108-173 amended section 1833(t)(16) of the Act to set a threshold of $50 per administration for the establishment of separate APCs for drugs and biologicals furnished from January 1, 2005, through December 31, 2006. Because this statutory provision will no longer be in effect for CY 2007, we have included in section V. of this preamble a discussion of the methodology that we will use to determine a threshold for establishing separate APCs for drugs and biologicals for CY 2007.

2. Special Payment for Brachytherapy

Section 621(b)(1) of Pub. L. 108-173 amended section 1833(t)(16) of the Act to require that payment for brachytherapy devices consisting of a seed or seeds (or radioactive source) furnished on or after January 1, 2004, and before January 1, 2007, be paid based on the hospital's charge for each device furnished, adjusted to cost. Because this statutory provision will no longer be in effect for CY 2007, we discuss our methodology for payment for brachytherapy devices for CY 2007 in section VII.B. of this preamble.

F. Provisions of the Deficit Reduction Act (DRA) of 2005

The Deficit Reduction Act (DRA) of 2005, Pub. L. 109-171, enacted on February 8, 2006, included three provisions affecting the OPPS, as discussed below.

1. 3-Year Transition of Hold Harmless Payments

Section 5105 of Pub. L. 109-171 provides a 3-year transition of hold harmless OPPS payments for hospitals Start Printed Page 67967located in a rural area with not more than 100 beds that are not defined as sole community hospitals (SCHs). This provision provides an increased payment for such hospitals for covered OPD services furnished on or after January 1, 2006, and before January 1, 2009, if the OPPS payment they receive is less than the pre-BBA payment amount that they would have received for the same covered OPD services. This provision specifies that, in such cases, the amount of payment to the specified hospitals shall be increased by the applicable percentage of such difference. Section 5105 specifies the applicable percentage as 95 percent for CY 2006, 90 percent for CY 2007, and 85 percent for CY 2008. This provision is discussed in section II.F.1. of the preamble.

2. Medicare Coverage of Ultrasound Screening for Abdominal Aortic Aneurysms (AAAs)

Section 5112 of Pub. L. 109-171 amended section 1861 of the Act to include coverage of ultrasound screening for abdominal aortic aneurysms for certain individuals on or after January 1, 2007. The provision will apply to individuals (a) who receive a referral for such an ultrasound screening as a result of an initial preventive physical examination; (b) who have not been previously furnished with an ultrasound screening under Medicare; and (c) who have a family history of abdominal aortic aneurysm or manifest risk factors included in a beneficiary category recommended for screening (as determined by the United States Preventive Services Task Force). Ultrasound screening for abdominal aortic aneurysm will be included in the initial preventive physical examination. Section 5112 also added ultrasound screening for abdominal aortic aneurysm to the list of services for which the beneficiary deductible does not apply. These amendments apply to services furnished on or after January 1, 2007. See section XIII.B. of this preamble for a detailed discussion of this provision.

3. Colorectal Cancer Screening

Section 5113 of Pub. L. 109-171 amended section 1833(b) of the Act to add colorectal cancer screening to the list of services for which the beneficiary deductible does not apply. This provision applies to services furnished on or after January 1, 2007. See the Medicare Physician Fee Schedule (MPFS) CY 2007 final rule for a detailed discussion of this provision.

G. Summary of the Provisions of the CY 2007 OPPS Proposed Rule

On August 23, 2006, we published a proposed rule in the Federal Register (71 FR 49506) that set forth proposed changes to the Medicare hospital OPPS for CY 2007 to implement statutory requirements and changes arising from our continuing experience with the system and to implement certain provisions of Pub. L. 109-171 specified in sections II.F.1. and XIII.B. of this preamble. We also proposed to revise the standard for critical access hospital personnel that are allowed to perform emergency medical screenings. In addition, we proposed changes to the Medicare ASC payment system for CY 2007 and CY 2008 and to the way we process fee-for-service (FFS) claims under Medicare Part A and Part B.

Finally, we set forth a proposed rule seeking comments on the RHQDAPU program under the Medicare hospital IPPS for FY 2008. These changes will be effective for payments beginning with FY 2008. The following is a summary of the major changes included in the CY 2007 OPPS proposed rule:

1. Updates to the OPPS' Payments for CY 2007

In the proposed rule, we set forth—

  • The methodology used to recalibrate the proposed APC relative payment weights and the proposed median costs for CY 2007.
  • The proposed payment for partial hospitalization, including the proposed separate threshold for outlier payments for CMHCs.
  • The proposed update to the conversion factor used to determine payment rates under the OPPS for CY 2007.
  • The proposed retention of our current policy to apply the IPPS wage indices to wage adjust the APC median costs in determining the OPPS payment rate and the copayment standardized amount for CY 2007.
  • The proposed update of statewide average default cost-to-charge ratios.
  • Proposed changes relating to the hold harmless payment provision and § 419.70(d).
  • Proposed changes relating to payment for rural SCHs, including Essential Access Community Hospitals (EACHs) for CY 2007.
  • The proposed retention of our current policy for calculating hospital outpatient outlier payments for CY 2007.
  • Calculation of the proposed national unadjusted Medicare OPPS payment.
  • The proposed beneficiary copayment for OPPS services for CY 2007.

2. Ambulatory Payment Classification (APC) Group Policies

In the proposed rule, we discussed establishing a number of new APCs and making changes to the assignment of HCPCS codes under a number of existing APCs based on our analyses of Medicare claims data and recommendations of the APC Panel. We also discussed the application of the 2 times rule and proposed exceptions to it; proposed changes for specific APCs; proposed movement of procedures from the New Technology APCs; and the proposed additions of new procedure codes to the APC groups.

3. Payment Changes for Devices

In the proposed rule, we discussed proposed changes to the device-dependent APCs and to payment for pass-through devices. We also discussed the proposed payment policy for devices that are replaced without cost or credit to the hospital for a replaced device and the proposed related regulation under § 419.45.

4. Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals

In the proposed rule, we discussed proposed payment changes for drugs, biologicals, and radiopharmaceuticals.

5. Estimate of Transitional Pass-Through Spending in CY 2007 for Drugs, Biologicals, and Devices

In the proposed rule, we discussed the proposed methodology for estimating total pass-through spending and whether there should be a pro rata reduction for transitional pass-through drugs, biologicals, radiopharmaceuticals, and categories of devices for CY 2007.

6. Brachytherapy Payment Changes

In the proposed rule, we included a discussion of our proposal concerning coding and payment for the sources of brachytherapy.

7. Coding and Payment for Drugs Administration

In the proposed rule, we discussed our proposed coding and payment changes for drug administration services.

8. Hospital Coding and Payments for Visits

In the proposed rule, we discussed our analyses of various guidelines for coding hospital visits and the proposed HCPCS codes and payment policy for those visits. Start Printed Page 67968

9. Payment for Blood and Blood Products

In the proposed rule, we discussed our proposed criteria and coding changes for the blood and blood products.

10. Payment for Observation Services

In the proposed rule, we discussed our proposed continuation of applying the criteria for separate payment for observation services and the coding methodology for observation services implemented in CY 2006.

11. Procedures That Will Be Paid Only as Inpatient Services

In the proposed rule, we discussed the procedures that we proposed to remove from the inpatient list and assign to APCs.

12. Nonrecurring Policy Changes

In the proposed rule, we discussed a proposed technical change to § 419.21(d) of the regulations related to Comprehensive Outpatient Rehabilitation Facility (CORF) services and proposed coding and payment for ultrasound screening for abdominal aortic aneurysms (AAAs) as a new service paid under the OPPS in CY 2007.

13. Emergency Medical Screening in Critical Access Hospitals (CAHs)

In the proposed rule, we discussed our proposal to revise § 485.618(d) of the regulations pertaining to the standards for critical access hospital personnel available to perform emergency medical screening services.

14. Payment Status and Comment Indicator Assignments

In the proposed rule, we discussed our list of status indicators assigned to APCs and presented our comment indicators that we proposed to use in this final rule with comment period.

15. OPPS Policy and Payment Recommendations

In the proposed rule, we addressed recommendations made by MedPAC, the APC Panel, and the GAO regarding the OPPS for CY 2007.

16. Policies Affecting Ambulatory Surgical Centers (ASCs) for CY 2007

In the proposed rule, we discussed changes to the ASC list of covered procedures for CY 2007; implementation of section 5103 of Pub. L. 108-173; our proposal for modifying the current ASC process for adjusting payment for new technology intraocular lenses; and related regulatory changes.

17. Revised ASC Payment System for Implementation January 1, 2008

In the proposed rule, we set forth our proposal to revise the current ASC payment system in accordance with Pub. L. 108-173, effective January 1, 2008. We note that we are not finalizing this proposal in this final rule with comment period. Rather, we will issue a separate document in the Federal Register that will address public comments received and finalize the ASC payment system effective January 1, 2008.

18. Medicare Contracting Reform Mandate

In the proposed rule, we set forth changes to the way we process FFS claims under Medicare Part A and Part B.

19. Reporting Quality Data for Improved Quality and Costs Under the OPPS

In the proposed rule, we proposed to adapt the quality improvement mechanism provided by the IPPS RHQDAPU program for use under the OPPS.

20. Promoting Effective Use of Health Information Technology

In the proposed rule, we discussed our plans to promote and adopt effective use of health information technology to improve the quality of care for Medicare beneficiaries.

21. Health Care Information Transparency Initiative

In the proposed rule, we announced our plans to launch a major health care transparency initiative in 2006.

22. Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for FY 2008 IPPS Annual Payment Update

In the proposed rule, we discussed our proposal to expand the IPPS Reporting Hospital Quality Data for Annual Payment program measurement set for FY 2008 beyond the measures adopted for the FY 2007 IPPS update.

23. Impact Analysis

In the proposed rule, we set forth an analysis of the impact that the proposed changes will have on affected entities and beneficiaries.

H. Public Comments Received in Response to the CY 2007 OPPS Proposal Rule and on the Reporting Hospital Quality Data for FY 2008 IPPS Annual Payment Update Program—HCAHPS Survey, SCIP, and Mortality Proposed Rule

We received approximately 1,100 timely items of correspondence containing multiple comments on the CY 2007 OPPS proposed rule. We note that we received some comments that were outside of the scope of the CY 2007 OPPS proposed rule. These comments are not addressed in the CY 2007 final rule. We also received approximately 20 timely items of correspondence on Reporting Hospital Quality Data for FY 2008 Inpatient Prospective Payment System Annual Payment Update Program—HCAHPS Survey, SCIP, and Mortality proposed rule. Summaries of the public comments and our responses to those comments are set forth under the appropriate headings.

I. Public Comments Received on the November 10, 2005 OPPS Final Rule with Comment Period

We received approximately 41 timely items of correspondence on the November 10, 2005 OPPS final rule with comment period, some of which contained multiple comments on the APC assignment of HCPCS codes identified with the NI comment indicator in Addendum B of that final rule with comment period. Summaries of those public comments and our responses to those comments are set forth in the various sections under the appropriate headings.

II. Updates Affecting OPPS Payments for CY 2007

A. Recalibration of APC Relative Weights for CY 2007

1. Database Construction

a. Database Source and Methodology

Section 1833(t)(9)(A) of the Act requires that the Secretary review and revise the relative payment weights for APCs at least annually. In the April 7, 2000 OPPS final rule with comment period (65 FR 18482), we explained in detail how we calculated the relative payment weights that were implemented on August 1, 2000, for each APC group. Except for some reweighting due to a small number of APC changes, these relative payment weights continued to be in effect for CY 2001. This policy is discussed in the November 13, 2000 interim final rule (65 FR 67824 through 67827). Start Printed Page 67969

In the CY 2007 OPPS proposed rule, we proposed to use the same basic methodology that we described in the April 7, 2000 final rule with comment period to recalibrate the APC relative payment weights for services furnished on or after January 1, 2007, and before January 1, 2008. That is, we would recalibrate the relative payment weights for each APC based on claims and cost report data for outpatient services. We proposed to use the most recent available data to construct the database for calculating APC group weights. For the purpose of recalibrating the APC relative payment weights for CY 2007, we used approximately 142.5 million final action claims for hospital OPD services furnished on or after January 1, 2005, and before January 1, 2006. Of the 142.5 million final action claims for services provided in hospital outpatient settings, 110.2 million claims were of the type of bill potentially appropriate for use in setting rates for OPPS services (but did not necessarily contain services payable under the OPPS). Of the 110.2 million claims, approximately 51.7 million were not for services paid under the OPPS or were excluded as not appropriate for use (for example, erroneous cost-to-charge ratios or no HCPCS codes reported on the claim). We were able to use 54.1 million whole claims of the remaining 58.5 million claims to set the OPPS APC relative weights for CY 2007 OPPS. From the 54.1 million whole claims, we created 98.5 million single records, of which 68.5 million were “pseudo” single claims (created from multiple procedure claims using the process we discuss in this section).

As proposed, the final APC relative weights and payments for CY 2007 in Addenda A and B to this final rule with comment period were calculated using claims from this period that had been processed before June 30, 2006, and continue to be based on the median hospital costs for services in the APC groups. We selected claims for services paid under the OPPS and matched these claims to the most recent cost report filed by the individual hospitals represented in our claims data.

Comment: Several commenters supported the use of the most recent claims and cost report data to calculate the median costs for use in the CY 2007 OPPS.

Response: We appreciate the commenters' support and have used the claims for services paid under the CY 2005 OPPS as processed through the common working file as of June 30, 2006, in the calculation of the median costs on which the CY 2007 OPPS rates are based. In addition, we have used the most recently submitted cost report data as reported to the HCRIS system as of June 30, 2006, to calculate the cost-to-charge ratios (CCRs) used to reduce the billed charges to costs for purposes of calculating the median costs on which the CY 2007 OPPS rates are based.

After carefully considering all comments received, we are finalizing our data source and methodology for the recalibration of CY 2007 APC relative payment weights as proposed without modification, as described in this section.

b. Use of Single and Multiple Procedure Claims

For CY 2007, we proposed to continue to use single procedure claims to set the medians on which the APC relative payment weights would be based. We have received many requests asking that we ensure that the data from claims that contain charges for multiple procedures are included in the data from which we calculate the relative payment weights. Requesters believe that relying solely on single procedure claims to recalibrate APC relative payment weights fails to take into account data for many frequently performed procedures, particularly those commonly performed in combination with other procedures. They believe that, by depending upon single procedure claims, we base relative payment weights on the least costly services, thereby introducing downward bias to the medians on which the weights are based.

We agree that, optimally, it is desirable to use the data from as many claims as possible to recalibrate the APC relative payment weights, including those with multiple procedures. We generally use single procedure claims to set the median costs for APCs because we are, so far, unable to ensure that packaged costs can be appropriately allocated across multiple procedures performed on the same date of service. However, by bypassing specified codes that we believe do not have significant packaged costs, we are able to use more data from multiple procedure claims. In many cases, this enables us to create multiple “pseudo” single claims from claims that, as submitted, contained multiple separately paid procedures on the same claim. For the CY 2007 OPPS, we proposed to use the date of service on the claims and a list of codes to be bypassed to create “pseudo” single claims from multiple procedure claims, as we did in recalibrating the CY 2006 APC relative payment weights. We refer to these newly created single procedure claims as “pseudo” single claims because they were submitted by providers as multiple procedure claims.

For CY 2003, we created “pseudo” single claims by bypassing HCPCS codes 93005 (Electrocardiogram, tracing), 71010 (Chest x-ray), and 71020 (Chest x-ray) on a submitted claim. However, we did not use claims data for the bypassed codes in the creation of the median costs for the APCs to which these three codes were assigned because the level of packaging that would have remained on the claim after we selected the bypass code was not apparent and, therefore, it was difficult to determine if the medians for these codes would be correct.

For CY 2004, we created “pseudo” single claims by bypassing these three codes and also by bypassing an additional 269 HCPCS codes in APCs. We selected these codes based on a clinical review of the services and because it was presumed that these codes had only very limited packaging and could appropriately be bypassed for the purpose of creating “pseudo” single claims. The APCs to which these codes were assigned were varied and included mammography, cardiac rehabilitation, and Level I plain film x-rays. To derive more “pseudo” single claims, we also split the claims where there were dates of service for revenue code charges on that claim that could be matched to a single procedure code on the claim on the same date.

For the CY 2004 OPPS, as in CY 2003, we did not include the claims data for the bypassed codes in the creation of the APCs to which the 269 codes were assigned because, again, we had not established that such an approach was appropriate and would aid in accurately estimating the median costs for those APCs. For CY 2004, from approximately 16.3 million otherwise unusable claims, we used approximately 9.5 million multiple procedure claims to create approximately 27 million “pseudo” single claims. For CY 2005, we identified 383 bypass codes and from approximately 24 million otherwise unusable claims, we used approximately 18 million multiple procedure claims to create approximately 52 million “pseudo” single claims. For CY 2005, we used the claims data for the bypass codes combined with the single procedure claims to set the median costs for the bypass codes.

For CY 2006, we continued using the codes on the CY 2005 OPPS bypass list and expanded it to include 404 bypass codes, including 3 bladder catheterization codes (CPT codes 51701, 51702, and 51703), which did not meet the empirical criteria discussed below for the selection of bypass codes. We added these three codes to the CY 2006 Start Printed Page 67970bypass list because a decision to change their payment status from packaged to separately paid would have resulted in a reduction of the number of single bills on which we could base median costs for other major separately paid procedures that were billed on the same claim with these three procedure codes. That is, single bills which contained other procedures would have become multiple procedure claims when these bladder catheterization codes were converted to separately paid status. We believed and continue to believe that bypassing these three codes does not adversely affect the medians for other procedures because we believe that when these services are performed on the same day as another separately paid service, any packaging that appears on the claim would be appropriately associated with the other procedure and not with these codes.

Consequently, for CY 2006, we identified 404 bypass codes for use in creating “pseudo” single claims and used some part of 90 percent of the total claims that were eligible for use in OPPS ratesetting and modeling in developing the final rule with comment period. This process enabled us to use, for the CY 2006 OPPS, 88 million single bills for ratesetting: 55 million “pseudo” singles and 34 million “natural” single bills (bills that were submitted containing only one separately payable major HCPCS code). (These numbers do not sum to 88 million because more than 800,000 single bills were removed when we trimmed at the HCPCS level at +/-3 standard deviations from the geometric mean.)

For CY 2007, we proposed to continue using date-of-service matching as a tool for creation of “pseudo” single claims and to continue the use of a bypass list to create “pseudo” single claims. The process we proposed for the CY 2007 OPPS resulted in our being able to use some part of 92.6 percent of the total claims that are eligible for use in the OPPS ratesetting and modeling in developing this final rule with comment period. This process enabled us to use, for CY 2007, 68.5 million “pseudo” singles and 31.6 million “natural” single bills.

We proposed to bypass the 454 codes identified in Table 1 of the proposed rule (71 FR 49517) to create new single claims and to use the line-item costs associated with the bypass codes on these claims, together with the single procedure claims, in the creation of the median costs for the APCs into which they are assigned. Of the codes on this list, 404 codes were used for bypass in CY 2006. We proposed to continue the use of the codes on the CY 2006 OPPS bypass list and to expand it by adding codes that, using data presented to the APC Panel at its March 2006 meeting, meet the same empirical criteria as those used in CY 2006 to create the bypass list, or which our clinicians believe would contain minimal packaging if the services were correctly coded (for example, ultrasound guidance). (Bypass codes shown in Table 1 with an asterisk indicated the HCPCS codes we proposed to add to the CY 2006 OPPS listed codes for bypass in CY 2007.) Our examination of the data against the criteria for inclusion on the bypass list, as discussed below for the addition of new codes, shows that the empirically selected codes used for bypass for the CY 2006 OPPS generally continue to meet the criteria or come very close to meeting the criteria, and we have received no comments against bypassing them.

As proposed, the following empirical criteria that we used to determine the additional codes to add to the CY 2006 OPPS bypass list to create the bypass list for the CY 2007 OPPS were developed by reviewing the frequency and magnitude of packaging in the single claims for payable codes other than drugs and biologicals. We assumed that the representation of packaging on the single claims for any given code is comparable to packaging for that code in the multiple claims:

  • There were 100 or more single claims for the code. This number of single claims ensured that observed outcomes were sufficiently representative of packaging that might occur in the multiple claims.
  • Five percent or fewer of the single claims for the code had packaged costs on that single claim for the code. This criterion results in limiting the amount of packaging being redistributed to the payable procedure remaining on the claim after the bypass code is removed and ensures that the costs associated with the bypass code represent the cost of the bypassed service.
  • The median cost of packaging observed in the single claims was equal to or less than $50. This limits the amount of error in redistributed costs.
  • The code is not a code for an unlisted service.

In addition, we proposed to add to the bypass list codes that our clinicians believe contain minimal packaging and codes for specified drug administration services for which hospitals have requested separate payment but for which it is not possible to acquire median costs unless we add these codes to the bypass list. A more complete discussion of the effects of adding these drug administration codes to the bypass list is contained in the discussion of drug administration payment changes in section VIII.C. of this preamble.

In the CY 2007 OPPS proposed rule, we specifically invited public comment on the “pseudo” single process, including the bypass list and the criteria.

Comment: The commenters urged CMS to continue to find ways to use all data from multiple procedure claims to set the median costs on which the payment rates are based. Many commenters supported the bypass list as a vehicle to enable use of all claims data. However, some commenters were concerned that placing HCPCS codes on the bypass list would lead to those codes being undervalued because no packaging from the multiple procedure bill is attributed to them. These commenters urged CMS to validate that these services were not being systematically undervalued by being bypassed and thus having many units of the service used for median setting with no attribution of packaging to the code. In many cases, the commenters did not offer specific discussion of what packaging they believe would be appropriately attached to the codes on the bypass list. One commenter suggested that CMS add CPT code 77421 (Steroscopic X-ray guidance for localization of target volume for the delivery of radiation therapy) to secure more single procedure claims data for median setting. Another commenter asked that CMS add CPT code 88307 (Level V-Surgical pathology, gross and microscopic examination) to the bypass list because it would be consistent with the inclusion of CPT codes 88304 (Level III-Surgical pathology, gross and microscopic examination) and 88305 (Level IV-Surgical pathology, gross and microscopic examination) on the bypass list.

Response: We agree that the bypass list has been very useful in enabling us to use data from multiple procedure claims to set median costs for many services. The use of date of service stratification and the bypass list enabled us to create 68.5 million “pseudo” single claims that would not otherwise have been used to set median costs for the CY 2007 OPPS. However, we recognize that it is necessary to be cautious in this approach to minimize the possibility that we could mistakenly apply packaging on the claim to the wrong service. For that reason, each year we investigate the amount of packaging on natural single bills and consider whether changes should be made to the bypass list. However, in some cases, we know that the natural single bills are incorrect, and it is not Start Printed Page 67971reasonable to base a decision on their level of packaging from what we believe are incorrectly coded claims. In these cases, we use clinical judgment to determine whether, on a correctly coded claim, the packaging would be associated with the code as defined or whether the packaging would more appropriately be associated with other procedures. For example, a single procedure bill for an ultrasound guidance service which is used only for guidance during an associated surgical procedure would not be correctly coded and therefore, clinically, we would not expect the packaged costs observed on these single claims to be correctly attributed to the guidance procedure. We believe that the ultrasound guidance procedure itself could not be the service that required the drugs, devices, or operating room use that would usually also be billed on a correctly coded claim. In these cases, we would place the ultrasound guidance procedure on the bypass list and attribute the packaged costs that appear on the same claim to the surgical procedure on the claim.

We have been actively investigating options for using all claims data in the establishment of median costs, and we intend to be ready to discuss our findings in the CY 2008 OPPS proposed rule. With respect to the suggestions for additions to the bypass list, we will evaluate the potential for adding CPT codes 77421 and 88307 to the bypass list for purposes of the CY 2008 OPPS ratesetting.

Comment: One commenter asked that CMS use all claims data on multiple procedure claims by allocating the packaging on a claim with multiple surgical procedures based on the currently existing relative weights to create “pseudo” single claims from all multiple procedure claims. The commenter suggested that if CMS is concerned about that process causing the weights being calculated to not reflect changes in cost, CMS might use this process only in cases in which the number of units for HCPCS codes on natural single bills are below some tolerance so that these claims would be used only on low volume procedures.

Response: We are concerned that use of the current relative weights to allocate the packaging on multiple procedure claims may cause packaging to be allocated inappropriately in some cases. As we indicate above, we are continuing to explore ways that packaging could be allocated on multiple procedure claims in such a way that we would have confidence in the allocation.

Comment: One commenter requested that CMS remove CPT code 76942 (Ultrasonic guidance for needle placement (eg biopsy, aspiration, injection, localization device), imaging supervision and interpretation) from the bypass list, because the commenter believed it would raise the median cost for APC 0268, the APC where CPT code 76942 is assigned for CY 2007. According to the commenter, the natural single claims for CPT code 76942 have a higher median cost than the “pseudo” single claims. The commenter indicated that when all packaged costs are removed from the natural singles, their median is close to the median for the “pseudo” single claims. If removing this code from the bypass list altogether results in too few “pseudo” single claims, the commenter requested that CMS calculate the median cost for APC 0268 using only natural single claims.

Response: We agree with the commenter that the median of APC 0268 is higher with the exclusion of “pseudo” singles that are created from claims that include CPT code 76942 than it would be if we only used true single claims that include CPT code 76942. However, we believe that the single bills for CPT code 76942 are miscoded and, therefore, inappropriately attribute the procedural costs (for example, the needle placement for biopsy and injection) to ultrasound guidance rather than the biopsy or aspiration procedures. We note that CPT code 76942 is the code with the highest frequency in APC 0268 and, therefore, contributes greatly to the median cost of the APC. The commenter provided no information regarding the specific packaging associated with CPT code 76942; therefore, we continue to believe that its inclusion on the bypass list, and the resulting calculation of the APC median cost for APC 0268, is appropriate.

After carefully considering all public comments received on our proposal, we are adopting as final the proposed “pseudo” single process and the bypass codes listed in Table 1.

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c. Revised Overall Cost-to-Charge Ratio (CCR) Calculation

We calculate both an overall CCR and cost center-specific cost-to-charge ratios (CCRs) for each hospital. For the CY 2007 OPPS, we proposed to change the methodology for calculating the overall CCR. The overall CCR is used in many components of the OPPS. We use the overall CCR to estimate costs from charges on a claim when we do not have an accurate cost center CCR. This does not happen very often. For the vast majority of services, we are able to use a cost center CCR to estimate costs from charges. However, we also use the overall CCR to identify the outlier threshold, to model payments for services that are paid at charges reduced to cost, and, during implementation, to determine outlier payments and payments for other services.

As stated in the CY 2007 OPPS proposed rule (71 FR 49528), we have discovered that the calculation of the overall CCR that the fiscal intermediaries are using to determine outlier payments and payments for services paid at charges reduced to cost differs from the overall CCR that we use to model the OPPS. In Program Transmittal A-03-04 on “Calculating Provider-Specific Outpatient Cost-to-Charge Ratios (CCRs) and Instructions on Cost Report Treatment of Hospital Outpatient Services Paid on a Reasonable Cost Basis” (January 17, 2003), we revised the overall CCR calculation that the fiscal intermediaries use in determining outlier and other cost payments. Until this point, each fiscal intermediary had used an overall CCR provided by CMS, or calculated an updated CCR at the provider's request using the same calculation. The calculation in Program Transmittal A-03-04, that is, the fiscal intermediary calculation, diverged from the “traditional” overall CCR that we used for modeling. It should be noted that the fiscal intermediary overall CCR calculation noted in Program Transmittal A-03-04 was created with feedback and input from the fiscal intermediaries.

CMS' “traditional” calculation consists of summing the total costs from Worksheet B, Part I (Column 27), after removing the costs for nursing and paramedical education (Columns 21 and 24), for those ancillary cost centers that we believe contain most OPPS services, summing the total charges from Worksheet C, Part I (Columns 6 and 7) for the same set of ancillary cost centers, and dividing the former by the latter. We exclude selected ancillary cost centers from our overall CCR calculation, such as 5700 Renal Dialysis, because we believe that the costs and Start Printed Page 67984charges in these cost centers are largely paid for under other payment systems. The specific list of ancillary cost centers, both standard and nonstandard, included in our overall CCR calculation is available on our Web site in the revenue center-to-cost center crosswalk workbook: http://www.cms.hhs.gov/​HospitalOutpatientPPS.

The overall CCR calculation provided in Program Transmittal A-03-04, on the other hand, takes the CCRs from Worksheet C, Part I, Column 9, for each specified ancillary cost center; multiplies them by the Medicare Part B outpatient specific charges in each corresponding ancillary cost center from Worksheet D, Part V (Columns 2, 3, 4, and 5 and subscripts thereof); and then divides the sum of these costs by the sum of charges for the specified ancillary cost centers from Worksheet D, Part V (Columns 2, 3, 4, and 5 and subscripts thereof). The elimination of the reference to Part VI in this final rule with comment period is not a change from the proposed methodology. We used only data from Worksheet D, Part V of the HCRIS electronic cost report to calculate the overall CCRs for both the proposed rule and final rule with comment period. We previously referenced both Part V and Part VI in the proposed rule and in prior rules because both Part V and Part VI appear on the same page in Worksheet D on the paper cost report, although no data from Part VI on the electronic cost report were used in the calculation.

Compared with our “traditional” overall CCR calculation that has been used for modeling OPPS and to calculate the median costs, this fiscal intermediary calculation of overall CCR fails to remove allied health costs and adds weighting by Medicare Part B charges.

In comparing these two calculations, we discovered that, on average, the overall CCR calculation being used by the fiscal intermediaries resulted in higher overall CCRs than under our “traditional” calculation. Using the most recent cost report data available for every provider with valid claims for CY 2004 as of November 2005, we estimated the median overall CCR using the traditional calculation to be 0.3040 (mean 0.3223) and the median overall CCR using the fiscal intermediary calculation to be 0.3309 (mean 0.3742). There also was much greater variability in the fiscal intermediary calculation of the overall CCR. The standard deviation under the “traditional” calculation was 0.1318, while the standard deviation using the fiscal intermediary's calculation was 0.2143. In part, the higher median estimate for the fiscal intermediary calculation is attributable to the inclusion of allied health costs for the over 700 hospitals with allied health programs. It is inappropriate to include these costs in the overall CCR calculation, because CMS already reimburses hospitals for the costs of these programs through cost report settlement. The higher median estimate and greater variability also is a function of the weighting by Medicare Part B charges. Because the fiscal intermediary overall CCR calculation is higher, on average, CMS has underestimated the outlier payment thresholds and, therefore, overpaid outlier payments. We also have underestimated spending for services paid at charges reduced to cost in our budget neutrality estimates.

In examining the two different calculations, we decided that elements of each methodology had merit. Clearly, as noted above, allied health costs should not be included in an overall CCR calculation. However, weighting by Medicare Part B charges from Worksheet D, Part V, makes the overall CCR calculation more specific to OPPS. Therefore, we proposed to adopt a single overall CCR calculation that incorporates weighting by Medicare Part B charges but excludes allied health costs for modeling and payment. Specifically, the proposed calculation removes allied health costs from cost center CCR calculations for specified ancillary cost centers, as discussed above, multiplies them by the Medicare Part B charges on Worksheet D, Part V, and sums these estimated Medicare costs. This sum is then divided by the sum of the same Medicare Part B charges for the same specified set of ancillary cost centers.

As we indicated in the proposed rule (71 FR 49528), using the same cost report data in this study, we estimated a median overall CCR for the proposed calculation of 0.3081 (mean 0.3389) with a standard deviation of 0.1583. The similarity to the median and standard deviation of the “traditional” overall CCR calculation noted above (median 0.3040 and standard deviation of 0.1318) masks some sizeable changes in overall CCR calculations for specific hospitals due largely to the inclusion of Medicare Part B weighting.

In order to isolate the overall impact of adopting this methodology on APC medians, we used the first 9 months of CY 2005 claims data to estimate APC median costs varying only the two methods of determining overall CCR. As stated in the CY 2007 OPPS proposed rule (71 FR 49528), we expected the impact to be limited because the majority of costs are estimated using a cost center-specific CCR and not the overall. As predicted, we observed minor changes in APC median costs from the adoption of the proposed overall CCR calculation. We largely observed differences of no more than 5 percent in either direction. The median overall percent change in APC cost estimates was −0.3 percent. We typically observe comparable changes in APC medians when we update our cost report data. Using updated cost report data for the calculations in this final rule with comment period, we estimate a median overall CCR across all hospitals of 0.3015 using the new overall CCR calculation.

We believe that a single overall CCR calculation should be used for all components of the OPPS for both modeling and payment. Therefore, we proposed to use the modified overall CCR calculation as discussed above when the hospital-specific overall CCR is used for any of the following calculations: in the CMS calculation of median costs for OPPS ratesetting, in the CMS calculation of the outlier threshold, in the fiscal intermediary calculation of outlier payments, in the CMS calculation of statewide CCRs, in the fiscal intermediary calculation of pass-through payments for devices, and for any other fiscal intermediary payment calculation in which the current hospital-specific overall CCR may be used now or in the future.

Comment: Several commenters supported the proposed change to the calculation of the overall CCR to be weighted by Part B charges and to exclude the costs of nursing and allied health professional education programs. One commenter asked that CMS provide examples at the line level of how the revenue code to cost center crosswalk is applied to sample claims to illustrate to hospitals how selection of the revenue code for any particular item or service controls the resulting cost that is used in median calculation. The commenter also asked that CMS instruct fiscal intermediaries to allow hospitals to reclassify expense and revenue whenever the hospital believes it is appropriate, to ensure that the charges on the claim result in appropriate costs for median setting and order the fiscal intermediaries not to reverse reclassification of costs in audit adjustments. The commenter also suggested that CMS should have fiscal intermediaries conduct a survey of their audit staff with regard to the validity of the revenue code to cost center crosswalk.

Response: We continue to believe that the proposed change to the CCR calculation is appropriate, and we have used the revised formula to calculate the Start Printed Page 67985overall CCRs used to set the medians on which the CY 2007 payment rates are based.

With respect to the request for detailed examples to illustrate how selection of a revenue code will control the cost that is used in the median calculation, we believe that hospitals, like any business, are responsible for performing their own analysis regarding issues that affect their revenue stream. We have gone to great lengths in the preamble of our proposed and final rules to discuss how we derive costs from charges and how we crosswalk the charge from the revenue code reported for the charge to the cost center on the cost report. Moreover, the revenue code to cost center crosswalk has been on the CMS Web site for several years, open continuously to public comment. We do not believe it is necessary to create and publish examples at the claim-line level to further elaborate on how we convert charges to costs for purposes of establishing median costs. Hospitals that are interested should have sufficient information available already on this topic. Moreover, Medicare auditing rules have been well-established and standardized over many years, and we rely on our contractors to enforce them appropriately.

Comment: One commenter suggested that CMS study the crosswalk that is used in the completion of the Provider Statistical and Reimbursement Report (PS&R) to determine whether changes to the CMS crosswalk of revenue codes to cost centers might be appropriate. Specifically, the commenter suggested the following revisions: Revenue code 0413 (hyperbaric oxygen therapy) should be crosswalked to the hospital overall CCR; Revenue code 026X (IV therapy) could have cost center 5600 (Drugs charges to patients) as the secondary default CCR before defaulting to the overall CCR; Revenue code 046X (Pulmondary therapy) should have cost center 4600 (respiratory therapy) as secondary and cost center 3160 as tertiary; and Revenue code 074X (EEG) should have cost center 5400 (EEG) as primary and cost center 3280 (EKG and EEG) as secondary.

Response: We have not made any changes in response to the commenter's suggestions for CY 2007. However, we will carefully examine the commenter's suggestions with regard to the calculation of CCRs for the CY 2008 OPPS.

After carefully considering all the public comments received, we are adopting our proposal for CY 2007 without modification. As stated in the CY 2007 proposed rule (71 FR 49529), we will issue a Medicare program instruction to fiscal intermediaries that will instruct them to recalculate and use the hospital-specific overall CCR as we have finalized for the above stated purposes.

2. Calculation of Median Costs for CY 2007

In this section of the preamble, we discuss the use of claims to calculate the proposed OPPS payment rates for CY 2007. The hospital outpatient prospective payment page on the CMS Web site on which this final rule with comment period is posted provides an accounting of claims used in the development of the final rates: http://www.cms.hhs.gov/​HospitalOutpatientPPS. The accounting of claims used in the development of this final rule with comment period is included on the Web site under supplemental materials for the CY 2007 final rule with comment period. That accounting provides additional detail regarding the number of claims derived at each stage of the process. In addition, below we discuss the files of claims that comprise the data sets that are available for purchase under a CMS data user contract. Our CMS Web site, http://www.cms.hhs.gov/​HospitalOutpatientPPS, includes information about purchasing the following two OPPS data files: “OPPS Limited Data Set” and “OPPS Identifiable Data Set.”

As proposed, we used the following methodology to establish the relative weights to be used in calculating the OPPS payment rates for CY 2007 shown in Addenda A and B to this final rule with comment period. This methodology is as follows:

We used outpatient claims for the full CY 2005, processed before June 30, 2006, to set the relative weights for CY 2007. To begin the calculation of the relative weights for CY 2007, we pulled all claims for outpatient services furnished in CY 2005 from the national claims history file. This is not the population of claims paid under the OPPS, but all outpatient claims (including, for example, CAH claims, and hospital claims for clinical laboratory services for persons who are neither inpatients nor outpatients of the hospital).

We then excluded claims with condition codes 04, 20, 21, and 77. These are claims that providers submitted to Medicare knowing that no payment will be made. For example, providers submit claims with a condition code 21 to elicit an official denial notice from Medicare and document that a service is not covered. We then excluded claims for services furnished in Maryland, Guam, and the U.S. Virgin Islands, American Samoa, and the Northern Marianas because hospitals in those geographic areas are not paid under the OPPS.

We divided the remaining claims into the three groups shown below. Groups 2 and 3 comprise the 110 million claims that contain hospital bill types paid under the OPPS.

1. Claims that were not bill types 12X, 13X, 14X (hospital bill types), or 76X (CMHC bill types). Other bill types are not paid under the OPPS and, therefore, these claims were not used to set OPPS payment.

2. Claims that were bill types 12X, 13X, or 14X (hospital bill types). These claims are hospital outpatient claims.

3. Claims that were bill type 76X (CMHC). (These claims are later combined with any claims in item 2 above with a condition code 41 to set the per diem partial hospitalization rate determined through a separate process.)

For the CCR calculation process, we used the same general approach as we used in developing the final APC rates for CY 2006 (70 FR 68537), with a change to the development of the overall CCR as discussed above. That is, we first limited the population of cost reports to only those for hospitals that filed outpatient claims in CY 2005 before determining whether the CCRs for such hospitals were valid.

We then calculated the CCRs at a cost center level and overall for each hospital for which we had claims data. We did this using hospital-specific data from the Healthcare Cost Report Information System (HCRIS). We used the most recent available cost report data, in most cases, cost reports for CY 2004. As proposed, for this final rule with comment period, we used the most recently submitted cost report to calculate the CCRs to be used to calculate median costs for the CY 2007 OPPS. If the most recent available cost report was submitted but not settled, we looked at the last settled cost report to determine the ratio of submitted to settled cost using the overall CCR, and we then adjusted the most recent available submitted but not settled cost report using that ratio. We calculated both an overall CCR and cost center-specific CCRs for each hospital. We used the final overall CCR calculation discussed in II.A.1.c. of this preamble for all purposes that require use of an overall CCR.

We then flagged CAH claims, which are not paid under the OPPS, and claims from hospitals with invalid CCRs. The latter included claims from hospitals without a CCR; those from hospitals paid an all-inclusive rate; those from Start Printed Page 67986hospitals with obviously erroneous CCRs (greater than 90 or less than .0001); and those from hospitals with CCRs that were identified as outliers (3 standard deviations from the geometric mean after removing error CCRs). In addition, we trimmed the CCRs at the cost center level by removing the CCRs for each cost center as outliers if they exceeded ±3 standard deviations from the geometric mean. This is the same methodology that we used in developing the final CY 2006 CCRs. For CY 2007, we proposed to trim at the departmental CCR level to eliminate aberrant CCRs that, if found in high volume hospitals, could skew the medians. We used a four-tiered hierarchy of cost center CCRs to match a cost center to every possible revenue code appearing in the outpatient claims, with the top tier being the most common cost center and the last tier being the default CCR. If a hospital's cost center CCR was deleted by trimming, we set the CCR for that cost center to “missing,” so that another cost center CCR in the revenue center hierarchy could apply. If no other departmental CCR could apply to the revenue code on the claim, we used the hospital's overall CCR for the revenue code in question. For example, if a visit was reported under the clinic revenue code, but the hospital did not have a clinic cost center, we mapped the hospital-specific overall CCR to the clinic revenue code. The hierarchy of CCRs is available for inspection and comment at the CMS Web site: http://www.cms.hhs.gov/​HospitalOutpatientPPS.

We then converted the charges to costs on each claim by applying the CCR that we believed was best suited to the revenue code indicated on the line with the charge. Table 2 of the proposed rule (71 FR 49532) contained a list of the allowed revenue codes. Revenue codes not included in Table 2 are those not allowed under the OPPS because their services cannot be paid under the OPPS (for example, inpatient room and board charges) and thus, charges with those revenue codes were not packaged for creation of the OPPS median costs. One exception is the calculation of median blood costs, as discussed in section X. of this preamble.

Thus, we applied CCRs as described above to claims with bill types 12X, 13X, or 14X, excluding all claims from CAHs and hospitals in Maryland, Guam, and the U.S. Virgin Islands, American Samoa, and the Northern Marianas and claims from all hospitals for which CCRs were flagged as invalid.

We identified claims with condition code 41 as partial hospitalization services of hospitals and moved them to another file. These claims were combined with the 76X claims identified previously to calculate the partial hospitalization per diem rate.

We then excluded claims without a HCPCS code. We also moved claims for observation services to another file. We moved to another file claims that contained nothing but influenza and pneumococcal pneumonia (“PPV”) vaccine. Influenza and PPV vaccines are paid at reasonable cost and, therefore, these claims are not used to set OPPS rates. We note that the two above mentioned separate files containing partial hospitalization claims and observation services claims are included in the files that are available for purchase as discussed above.

We next copied line-item costs for drugs, blood, and devices (the lines stay on the claim, but are copied off onto another file) to a separate file. No claims were deleted when we copied these lines onto another file. These line-items are used to calculate a per unit mean and median and a per day mean and median for drugs, radiopharmaceutical agents, blood and blood products, and devices, including but not limited to brachytherapy sources, as well as other information used to set payment rates, including a unit to day ratio for drugs.

We then divided the remaining claims into the following five groups:

1. Single Major Claims: Claims with a single separately payable procedure (that is, status indicator S, T, V, or X), all of which would be used in median setting.

2. Multiple Major Claims: Claims with more than one separately payable procedure (that is, status indicator S, T, V, or X), or multiple units for one payable procedure. As discussed below, some of these can be used in median setting.

3. Single Minor Claims: Claims with a single HCPCS code that is packaged (that is, status indicator N) and not separately payable.

4. Multiple Minor Claims: Claims with multiple HCPCS codes that are packaged (that is, status indicator N) and not separately payable.

5. Non-OPPS Claims: Claims that contain no services payable under the OPPS (that is, all status indicators other than S, T, V, X, or N). These claims are excluded from the files used for the OPPS. Non-OPPS claims have codes paid under other fee schedules, for example, durable medical equipment or clinical laboratory, and do not contain either a code for a separately paid service or a code for a packaged service.

In previous years, we made a determination of whether each HCPCS code was a major code, or a minor code, or a code other than a major or minor code. We used those code-specific determinations to sort claims into these five identified groups. For the CY 2007 OPPS, we proposed to use status indicators, as described above, to sort the claims into these groups. We believed that using status indicators was an appropriate way to sort the claims into these groups and also to make our process more transparent to the public. We further believed that this proposed method of sorting claims would enhance the public's ability to derive useful information and become a more informed commenter on the proposed rule.

We note that the claims listed in numbers 1, 2, 3, and 4 above are included in the data files that can be purchased as described above.

We set aside the single minor, multiple minor claims and the non-OPPS claims (numbers 3, 4, and 5 above) because we did not use these claims in calculating median costs. We then examined the multiple major claims for date of service to determine if we could break them into single procedure claims using the dates of service on all lines on the claim. If we could create claims with single major procedures by using date of service, we created a single procedure claim record for each separately paid procedure on a different date of service (that is, a “pseudo” single).

We then used the “bypass codes” listed in Table 1 of the proposed rule (71 FR 49517) and discussed in section II.A.1.b. of this preamble to remove separately payable procedures that we determined contain limited costs or no packaged costs, or were otherwise suitable for inclusion on the bypass list, from a multiple procedure bill. When one of the two separately payable procedures on a multiple procedure claim was on the bypass code list, we split the claim into two single procedure claims records. The single procedure claim record that contained the bypass code did not retain packaged services. The single procedure claim record that contained the other separately payable procedure (but no bypass code) retained the packaged revenue code charges and the packaged HCPCS charges.

We also removed lines that contained multiple units of codes on the bypass list and treated them as “pseudo” single claims by dividing the cost for the multiple units by the number of units on the line. Where one unit of a single separately paid procedure code remained on the claim after removal of the multiple units of the bypass code, we created a “pseudo” single claim Start Printed Page 67987from that residual claim record, which retained the costs of packaged revenue codes and packaged HCPCS codes. This enabled us to use claims that would otherwise be multiple procedure claims and could not be used. We excluded those claims that we were not able to convert to singles even after applying all of the techniques for creation of “pseudo” singles.

We then packaged the costs of packaged HCPCS codes (codes with status indicator “N” listed in Addendum B to this proposed rule) and packaged revenue codes into the cost of the single major procedure remaining on the claim. The list of packaged revenue codes was shown in Table 2 of the CY 2007 OPPS proposed rule (71 FR 49532) and below.

After removing claims for hospitals with error CCRs, claims without HCPCS codes, claims for immunizations not covered under the OPPS, and claims for services not paid under the OPPS, 58.4 million claims were left. Of these 58.4 million claims, we were able to use some portion of 54.1 million whole claims (92.6 percent of the 58.4 million potentially usable claims) to create the 98.5 million single and “pseudo” single claims for use in the CY 2007 median development and for ratesetting.

We also excluded (1) claims that had zero costs after summing all costs on the claim and (2) claims containing packaging flag 3. Effective for services furnished on or after July 1, 2004, the Outpatient Code Editor (OCE) assigns packaging flag number 3 to claims on which hospitals submitted token charges for a service with status indicator “S” or “T” (a major separately paid service under OPPS) for which the fiscal intermediary is required to allocate the sum of charges for services with a status indicator equaling “S” or “T” based on the weight for the APC to which each code is assigned. We do not believe that these charges, which were token charges as submitted by the hospital, are valid reflections of hospital resources. Therefore, we deleted these claims. In the proposed rule, we deleted claims with payment flag 3 (not packaging flag 3) because we believed that payment flag 3 identified claims for which the charges were not as submitted by the provider as described above. As we were processing claims for this final rule with comment period, we realized that this was not the case and corrected the process to eliminate claims which, as described above, have charges that are not as submitted by the provider. See the CY 2007 final rule claims accounting under supporting documentation posted on our Web site, http://www.cms.hhs.gov/​HospitalOutpatientPPS, for this final rule with comment period for further explanation. We note that in this final rule with comment period, as stated in both the proposed rule and here, we have excluded those claims that we believed were not valid reflections of hospital resources.

We also deleted claims for which the charges equal the revenue center payment (that is, the Medicare payment) on the assumption that where the charge equals the payment, to apply a CCR to the charge would not yield a valid estimate of relative provider cost.

For the remaining claims, we then standardized 60 percent of the costs of the claim (which we have previously determined to be the labor-related portion) for geographic differences in labor input costs. We made this adjustment by determining the wage index that applied to the hospital that furnished the service and dividing the cost for the separately paid HCPCS code furnished by the hospital by that wage index. As has been our policy since the inception of the OPPS, we proposed to use the pre-reclassified wage indices for standardization because we believed that they better reflect the true costs of items and services in the area in which the hospital is located than the post-reclassification wage indices, and would result in the most accurate adjusted median costs.

We also excluded claims that were outside 3 standard deviations from the geometric mean of units for each HCPCS code on the bypass list (because, as discussed above, we used claims that contain multiple units of the bypass codes). We then deleted 438,440 single bills reported with modifier 50 that were assigned to APCs that contained HCPCS codes that are considered to be conditional or independent bilateral procedures under the OPPS and that are subject to special payment provisions implemented through the OCE. Modifier 50 signifies that the procedure was performed bilaterally. Although these are apparently single claims for a separately payable service and although there is only one unit of the code reported on the claim, the presence of modifier 50 signifies that two services were furnished. Therefore, costs reported on these claims are for two procedures and not for a single procedure. Hence, we deleted these multiple procedure records, which we would have treated as single procedure claims in prior OPPS updates.

We used the remaining claims to calculate median costs for each separately payable HCPCS code and each APC. The comparison of HCPCS and APC medians determines the applicability of the “2 times” rule. As stated previously, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the group is more than 2 times greater than the lowest median cost for an item or service within the same group (“the 2 times rule”). Finally, we reviewed the medians and reassigned HCPCS codes to different APCs as deemed appropriate. Section III.B. of this preamble includes a discussion of the HCPCS code assignment changes that resulted from examination of the medians and for other reasons. The APC medians were recalculated after we reassigned the affected HCPCS codes. Both the HCPCS medians and the APC medians were weighted to account for the inclusion of multiple units of the bypass codes in the creation of pseudo single bills.

A detailed discussion of the medians for blood and blood products is included in section X. of this preamble. A discussion of the medians for APCs that require one or more devices when the service is performed is included in section IV.A. of this preamble. A discussion of the median for observation services is included in section XI. of this preamble, and a discussion of the median for partial hospitalization is included below in section II.B. of this preamble.

We specifically invited public comment on the relative benefits of deleting claims reported with modifier 50 signifying two procedures were performed versus dividing the costs for the two procedures by two to create two “pseudo” single claims. We received one comment on this issue.

Comment: One commenter supported deletion of the conditional or independent bilateral service claims because the commenter believes that the total cost of a bilateral procedure (including packaged costs) is generally less than 2 times the total cost of a unilateral procedure, and such cost savings are already reflected in each hospital's CCR. The commenter stated that to divide the cost of the bilateral procedure by two would result in “pseudo” singles that would underrepresent the full cost of a single procedure.

Response: We have excluded claims for conditional and independent bilateral procedures from the claims we used to calculate the median costs for the CY 2007 OPPS. We will carefully consider how to treat these claims for future years. Start Printed Page 67988

For the final CY 2007 OPPS ratesetting process, we deleted these claims, as we did for the proposed rule.

We received many comments on our proposed CY OPPS data process. A summary of the comments and our responses follows:

Comment: The commenters objected to what they view as wide fluctuations in the APC payment rates from CY 2006 to CY 2007, because such variability makes it difficult to plan and budget for the services that the hospital will provide in the upcoming year. The commenters objected to changes in proposed OPPS rates that are greater than 5 percent from the prior year's rates and urged CMS to adjust rates so that no payment rate in CY 2007 declined by more than 5 percent compared to its payment in CY 2006. The commenters stated that more than 250 APC rates declined compared to their CY 2006 rates, some by 10 to 20 percent or more. In contrast, they noted that over 300 APC rates increased, many substantially and by up to 30 percent compared to their CY 2006 rates. The commenters stated that they did not believe that the changes in the median costs were reflective of changes in hospital costs, because hospital costs do not vary so widely from year to year. The commenters indicated that they expected that after more than 5 years of experience, the rates would no longer show such significant volatility and urged CMS to use more multiple claims data to set the median costs.

Response: There are a number of factors pertinent to the OPPS that cause median costs to change from one year to the next. These include reassignment of HCPCS codes to APCs to rectify 2 times violations and to respond to public comments; the need to split costs derived from claims data among the many different HCPCS codes, which results in very few usable claims for some services; and annual changes in reported hospital charges and costs that provide the source of the cost data on which the system is based.

Although the APC number and title may remain the same from year to year, we routinely reassign HCPCS codes to different APCs to resolve violations of the 2 times rule as required by law or reconfigure APCs to create more levels in a series. We also reassign codes in response to public comments when we believe that the requested reassignment will result in improved clinical homogeneity and more similar resource use for a particular service or group of services. To the extent that there has been a reassignment either into or out of an APC or a reconfiguration of an APC into multiple levels, a comparison of the APC median from 1 year to the next is often not a valid comparison of the costs for the same services. In addition, every year new HCPCS codes that were initially assigned to clinical APCs for payment purposes may begin to contribute claims data to those APC median costs, also leading to ill-founded comparisons across years.

Moreover, many of the claims we receive for OPPS services are multiple procedure claims that must be fragmented for use in establishing the median costs for single procedures. Unlike other prospective payment systems in which the costs of multiple services are aggregated into a single payment for a defined encounter (for example, inpatient stay and home health episode of care), under the OPPS the costs that reflect the charges on Medicare claims that contain more than a single service on the same date must be fragmented into pieces to provide costs at a unit level, rather than being aggregated to provide the total cost for a set of services furnished in a single encounter. The more the costs on claims are split to accommodate payment for individual items and services described by HCPCS codes, and the fewer single bills that are available for ratesetting because the costs cannot be fragmented into unique services, the more variability is introduced into the cost. Because of the difficulty in assigning the revenue code charge data that hospitals submit on multiple procedure claims to the separately payable HCPCS codes that form the basis of payment in the OPPS, we must often use small numbers of claims to set the median costs for some services. We believe that the small numbers of single claims are the source of much of the volatility in the payment system. When we examine claims data for APCs like the Visit APCs, for which we have large and stable numbers of services, we do not see the median cost fluctuations that typically occur in those APCs for which we regularly have small numbers of single bills.

However, we are rarely asked for larger APCs that contain more codes or for more packaging of payment for HCPCS codes into the APC rates, both of which would enable us to use more claims and, we believe, provide more stable payment rates. Indeed, payment in the OPPS has become more specific each year, largely in response to our willingness to accommodate the requests of stakeholders when we believe they are justified and supported by the data. Each year, we are asked for increasingly more APCs that contain fewer HCPCS codes, as well as more precise costing of particular services. Generally, the comments received in response to our proposed rule asked for more separate payment, less packaging, and greater service-specific precision in the calculation of median costs for specifically identified services in the OPPS. We are also often asked to specifically recalculate median costs by using subsets of claims that meet specific criteria or by applying alternative methodologies for identified services. While these special approaches are generally intended to increase payments for their particular services of interest, they likely contribute to less stability in the system in general. Inevitably, such specificity would lead to more, not less, volatility as it would reduce the number of claims that can be used to set median costs.

Lastly, hospital charges and costs are the foundation of the payment weights, but hospitals change the mix of services they furnish and thereby also change their cost structure to some extent each year. Moreover, hospitals increase, sometimes decrease, or hold steady their charges each year based on a variety of business reasons, but these changes to charges often vary across the different services they furnish. Thus, hospital decisions to change their mix of services or to change their charges for some services differentially also contribute to the volatility in payment rates.

We recognize that it could be desirable for a payment system's rates to not vary by a certain percentage from the prior year's payment rates, but there is no reason to believe that limiting the changes in payment rates to prevent a decline by any percentage each year would be accurately reflective of changes in relative costs. Although the commenters asked that no payment for any service decline by more than 5 percent, none addressed a limitation for a payment increase. We do not believe that it is appropriate to artificially impose limits on a payment rate's increase or decrease from one year to the next, because, as noted above, comparisons between APC payment rates from year to year have little meaning for the many APCs that have experienced HCPCS migration. Moreover, to limit the increases or decreases in payment to a set amount for all services would conflict with the statutory requirement that at least annually we revise APCs and other components of the OPPS using new cost data and other relevant information. Therefore, we are not adjusting the rates as requested to account for a decline of more than 5 percent from CY 2006 in the final CY 2007 OPPS payment rates. We will continue to explore ways to use the data from multiple procedure claims because we agree that a high level of Start Printed Page 67989volatility is not desirable in the OPPS, and we also believe that the most viable long term solution to instability is the use of all the claims data. However, we also believe that changes in median costs from one year to the next are unavoidable in a relative weight payment system which also depends on hospital charges and costs and in which reassignment of HCPCS codes from one APC to another is required by law in cases of 2 times violations. As the commenters noted, some CY 2007 APC payment rates decrease but others increase in comparison with the CY 2006 rates, consistent with expectations for a budget neutral payment system like the OPPS.

Comment: One commenter objected to the inclusion of charges from the following revenue codes as packaged services under the OPPS: (1) Revenue code 274 (Prosthetic/orthotic devices) on the basis that the revenue code is for nonimplanted devices that require a HCPCS code, are paid under the MPFS, and have a status indicator of “A” under the OPPS; (2) Revenue code 280 (Oncology) on the basis that there is no oncology service that would not be coded by a HCPCS code, and, therefore, any charge without a HCPCS code should not be packaged; (3) Revenue code 290 (Durable Medical Equipment (DME)) on the basis that DME is for use in the home and not in the outpatient setting; (4) Revenue codes 343 and 344 (Diagnostic radiopharmaceuticals and therapeutic radiopharmaceuticals) on the basis that they are required to be billed with a HCPCS code, and, therefore, charges without a HCPCS code should not be packaged; and (5) Revenue code 560 (Medical Social Services) on the basis that they are separately billable only by home health agencies and are, therefore, suspect and should not be packaged.

Response: With a few limited exceptions, CMS does not specify the revenue codes hospitals must use to report their charges. Therefore, we selected a generous set of revenue codes to maximize the likelihood that we would capture all of the costs of a particular service for purposes of calculating the median costs on which the OPPS payment rates are based. To cease packaging costs under these revenue codes where there is no HCPCS code reported on the line may result in erroneous reductions in median costs and, therefore, in the related OPPS payment rates. With regard to the specific concerns of the commenter, our responses regarding the rationale for packaging the revenue code charges for each revenue code of interest follow: (1) Revenue code 274 is one of the revenue codes we previously instructed hospitals to use to report devices that had been paid as pass-through devices; (2) Revenue code 280 is packaged because we believe that it is possible that a hospital could have costs related to packaged OPPS services for which it would choose not to bill a HCPCS code, and we want to ensure that those costs are not lost in median calculation; (3) Revenue code 290 (DME) is governed by the statute which explicitly states that implantable DME provided in hospitals is paid under the OPPS, and we believe that it is possible that hospitals may charge for implantable DME but not bill a HCPCS code for the items; (4) Revenue codes 343 and 344 (diagnostic and therapeutic radiopharmaceuticals) are included as hospitals may charge for these items without placing a HCPCS code on the line; (5) Revenue code 560 (Medical Social Services) is included because hospitals may charge without billing a HCPCS code for the services of a medical social worker that are related to a visit service and thus would otherwise not be packaged into the median cost for the visit. We note that National Uniform Billing Committee guidelines on use of revenue code 560 recognize that it may be reported by hospitals in some circumstances.

Comment: One commenter asked that CMS implement an indirect medical education adjustment under the CY 2007 OPPS to address what the commenter states is a 23-percent shortfall to the market basket for OPPS services. The commenter indicated that this adjustment was needed to reimburse hospitals for the higher costs incurred by major teaching hospitals to provide outpatient care to Medicare beneficiaries.

Response: We do not believe an indirect medical education add-on payment is appropriate in a budget neutral payment system where such changes would result in reduced payments to all other hospitals. Moreover, in this final rule with comment period, we have developed payment weights that we believe resolve many of the public concerns regarding appropriate payments for new technology services and device-dependent procedures that we believe are furnished largely by teaching hospitals. We believe this and other payment changes should help ensure adequate and appropriate payment for teaching hospitals.

Comment: One commenter supported CMS' proposal to discard claims that contain token charges for packaged devices but opposed discarding claims when there is only one separately paid procedure on the claim, although there are other packaged services billed with token charges on other lines of the claim.

Response: We have not discarded claims that contain token charges where there is only one separately paid procedure on the claim if there are other packaged services billed with token charges on other lines of the claim. We discarded claims with token charges only when such claims included token charges for devices with procedure codes that are assigned to device-dependent APCs, because we instructed hospitals to bill token charges for devices that were replaced without cost to the provider due for example, to warranty, field action or recall. We also discarded claims that, as submitted, contained token charges for separately paid (not packaged) procedure codes, which during claims processing were converted to imputed charges for purposes of applying the outlier policy and which came to us through the national claims history with the imputed charges. These claims are identified with a packaging flag 3 and are excluded because the charges shown on the claim we receive were not the charges submitted by the provider. We discuss this in more detail in the CY 2007 final rule claims accounting on the CMS OPPS Web page at http://www.cms.hhs.gov/​HospitalOutpatientPPS/​.

After carefully considering all public comments received, we are finalizing the list of packaged services by revenue code shown in Table 2 and our data process for calculating the median costs for OPPS services furnished on or after January 1, 2007, without modification. Table 2 below contains the list of packaged services by revenue code that we used in developing the APC relative weights listed in Addenda A and B of this final rule with comment period.

Table 2.—CY 2007 Packaged Services by Revenue Code

Revenue codeDescription
250PHARMACY.
Start Printed Page 67990
251GENERIC.
252NONGENERIC.
254PHARMACY INCIDENT TO OTHER DIAGNOSTIC.
255PHARMACY INCIDENT TO RADIOLOGY.
257NONPRESCRIPTION DRUGS.
258IV SOLUTIONS.
259OTHER PHARMACY.
260IV THERAPY, GENERAL CLASS.
262IV THERAPY/PHARMACY SERVICES.
263SUPPLY/DELIVERY.
264IV THERAPY/SUPPLIES.
269OTHER IV THERAPY.
270M&S SUPPLIES.
271NONSTERILE SUPPLIES.
272STERILE SUPPLIES.
274PROSTHETIC/ORTHOTIC DEVICES.
275PACEMAKER DRUG.
276INTRAOCULAR LENS SOURCE DRUG.
278OTHER IMPLANTS.
279OTHER M&S SUPPLIES.
280ONCOLOGY.
289OTHER ONCOLOGY.
290DURABLE MEDICAL EQUIPMENT.
343DIAGNOSTIC RADIOPHARMS.
344THERAPEUTIC RADIOPHARMS.
370ANESTHESIA.
371ANESTHESIA INCIDENT TO RADIOLOGY.
372ANESTHESIA INCIDENT TO OTHER DIAGNOSTIC.
379OTHER ANESTHESIA.
390BLOOD STORAGE AND PROCESSING.
399OTHER BLOOD STORAGE AND PROCESSING.
560MEDICAL SOCIAL SERVICES.
569OTHER MEDICAL SOCIAL SERVICES.
621SUPPLIES INCIDENT TO RADIOLOGY.
622SUPPLIES INCIDENT TO OTHER DIAGNOSTIC.
624INVESTIGATIONAL DEVICE (IDE).
630DRUGS REQUIRING SPECIFIC IDENTIFICATION, GENERAL CLASS.
631SINGLE SOURCE.
632MULTIPLE.
633RESTRICTIVE PRESCRIPTION.
681TRAUMA RESPONSE, LEVEL I.
682TRAUMA RESPONSE, LEVEL II.
683TRAUMA RESPONSE, LEVEL III.
684TRAUMA RESPONSE, LEVEL IV.
689TRAUMA RESPONSE, OTHER.
700CAST ROOM.
709OTHER CAST ROOM.
710RECOVERY ROOM.
719OTHER RECOVERY ROOM.
720LABOR ROOM.
721LABOR.
762OBSERVATION ROOM.
810ORGAN ACQUISITION.
819OTHER ORGAN ACQUISITION.
942EDUCATION/TRAINING.

3. Calculation of Scaled OPPS Payment Weights

Using the median APC costs discussed previously, we calculated the final relative payment weights for each APC for CY 2007 shown in Addenda A and B of this final rule with comment period. In prior years, we scaled all the relative payment weights to APC 0601 (Mid Level Clinic Visit) because it is one of the most frequently performed services in the hospital outpatient setting. We assigned APC 0601 a relative payment weight of 1.00 and divided the median cost for each APC by the median cost for APC 0601 to derive the relative payment weight for each APC.

As proposed, for the CY 2007 OPPS, we scaled all of the relative payment weights to APC 0606 (Level 3 Clinic Visits) because we deleted APC 0601, as part of the reconfiguration of the visit APCs. We chose APC 0606 as the scaling base because under our proposal to reconfigure the APCs where clinic visits are assigned for CY 2007, APC 0606 is the middle level clinic visit APC (that is, Level 3 of five levels). We have historically used the median cost of the middle level clinic visit APC (that is APC 0601 through CY 2006) to calculate unscaled weights because mid-level clinic visits are among the most frequently performed services in the hospital outpatient setting. Therefore, to maintain consistency in using a median Start Printed Page 67991for calculating unscaled weights representing the median cost of some of the most frequently provided services, we proposed to continue to use the median cost of the middle level clinic APC, proposed APC 0606, to calculate unscaled weights. Following our standard methodology, but using the CY 2007 median for APC 0606, we assigned APC 0606 a relative payment weight of 1.00 and divided the median cost of each APC by the median cost for APC 0606 to derive the unscaled relative payment weight for each APC. The choice of the APC on which to base the relative weights for all other APCs does not affect the payments made under the OPPS because we scale the weights for budget neutrality.

Section 1833(t)(9)(B) of the Act requires that APC reclassification and recalibration changes, wage index changes, and other adjustments be made in a manner that assures that aggregate payments under the OPPS for CY 2007 are neither greater than nor less than the aggregate payments that would have been made without the changes. To comply with this requirement concerning the APC changes, we compared aggregate payments using the CY 2006 relative weights to aggregate payments using the CY 2007 final relative payment weights. Based on this comparison, we adjusted the relative weights for purposes of budget neutrality. The unscaled relative payment weights were adjusted by 1.364598352 for budget neutrality. We recognize the scaler, or weight scaling factor, for budget neutrality that we proposed for CY 2007 is higher than any previous OPPS weight scaler as a result of our proposal to use APC 0606 as the base for calculation of relative weights. Our use of the median cost for APC 0606 of $83.39 based on final rule with comment period data causes the unscaled weights to be lower than they would have been if we had chosen APC 0605 (Level 2 Clinic Visits; median $60.13 as the scaling base. The CY 2007 median cost of APC 0606 is significantly higher than the CY 2006 median cost of APC 0601 for mid-level clinic visits, which was used in CY 2006 and earlier years to calculate unscaled weights. Historically, the median cost for APC 0601 has been similar to the CY 2007 proposed median cost for APC 0605. In order to appropriately scale the total weight estimated for OPPS in CY 2007 to be similar to the total weight in OPPS for CY 2006, we calculated a scaler of 1.364598352 for this final rule with comment period, which is higher using APC 0606 as the base than it would be if we used APC 0605 as the base. In addition to adjusting for increases and decreases in weight due the recalibration of APC medians, the scaler also accounts for any change in the base.

The final relative payment weights listed in Addenda A and B of this final rule with comment period incorporate the recalibration adjustments discussed in sections II.A.1. and 2. of this preamble.

Section 1833(t)(14)(H) of the Act, as added by section 621(a)(1) of Pub. L. 108-173, states that “Additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion factor, weighting and other adjustment factors for 2004 and 2005 under paragraph (9) but shall be taken into account for subsequent years.” Section 1833(t)(14) of the Act provides the payment rates for certain “specified covered outpatient drugs.” Therefore, the cost of those specified covered outpatient drugs (as discussed in section V. of this preamble) is now included in the budget neutrality calculations for CY 2007 OPPS.

Under section 1833(t)(16)(C) of the Act, as added by section 621(b)(1) of Pub. L. 108-173, payment for devices of brachytherapy consisting of a seed or seeds (or radioactive source) is to be made at charges adjusted to cost for services furnished on or after January 1, 2004, and before January 1, 2007. As we stated in our January 6, 2004 interim final rule, charges for the brachytherapy sources were not used in determining outlier payments, and payments for these items were excluded from budget neutrality calculations for the CY 2006 OPPS. We excluded these payments from budget neutrality calculations, in part, because of the challenge posed by estimating hospital-specific cost payment. As proposed, for CY 2007, we calculated specific payment rates for brachytherapy sources, which were subjected to scaling for budget neutrality. (We provide a discussion of brachytherapy payment issues, including their CY 2007 treatment with respect to outlier payments, under section VII. of this preamble.) Therefore, the costs of brachytherapy sources are accounted for in the scaler of 1.364598352.

4. Changes to Packaged Services

Payments for packaged services under the OPPS are bundled into the payments providers receive for separately payable services provided on the same day. Packaged services are identified by the status indicator “N.” Hospitals include charges for packaged services on their claims, and the costs associated with these packaged services are then bundled into the costs for separately payable procedures on those same claims in establishing payment rates for the separately payable services. This is consistent with the principles of a prospective payment system based upon groupings of services and in contrast to a fee schedule that provides individual payment for each service billed. Hospitals may use CPT codes to report any packaged services that were performed, consistent with CPT coding guidelines.

As a result of requests from the public, a Packaging Subcommittee to the APC Panel was established to review all the procedural CPT codes with a status indicator of “N.” Providers have often suggested that many packaged services could be provided alone, without any other separately payable services on the claim, and requested that these codes not be assigned status indicator “N.” In deciding whether to package a service or pay for a code separately, we consider a variety of factors, including whether the service is normally provided separately or in conjunction with other services; how likely it is for the costs of the packaged code to be appropriately mapped to the separately payable codes with which it was performed; and whether the expected cost of the service is relatively low.

The Packaging Subcommittee identified areas for change for some packaged CPT codes that it believed could frequently be provided to patients as the sole service on a given date and that required significant hospital resources as determined from hospital claims data.

Based on the comments received, additional issues, and new data that we shared with the Packaging Subcommittee concerning the packaging status of codes for CY 2007, the Packaging Subcommittee reviewed the packaging status of numerous HCPCS codes and reported its findings to the APC Panel at its March 2006 meeting. The APC Panel accepted the report of the Packaging Subcommittee, heard several presentations on certain packaged services, discussed the deliberations of the Packaging Subcommittee, and recommended that—

  • CMS pay separately for HCPCS code 0069T (Acoustic heart sound recording and computer analysis; acoustic heart sound and computer analysis only).
  • CMS maintain the packaged status of HCPCS code 0152T (Computer aided detection with further physician review for interpretation, with or without digitization of films radiographic images; chest radiograph(s)).Start Printed Page 67992
  • CMS maintain the packaged status of CPT code 36500 (Venous catheterization for selective blood organ sampling).
  • CMS pay separately for CPT code 36540 (Collection of blood specimen from a completely implantable venous access device) if there are no separately payable OPPS services on the claim.
  • CMS pay separately for CPT code 36600 (Arterial puncture; withdrawal of blood for diagnosis) if there are no separately payable OPPS services on the claim.
  • CMS pay separately for CPT code 38792 (Injection procedure for identification of sentinel node) if there are no separately payable OPPS services on the claim.
  • CMS maintain the packaged status of CPT codes 74328 (Endoscopic catheterization of the biliary ductal system, radiological supervision and interpretation), 74329 (Endoscopic catheterization of the pancreatic ductal system, radiological supervision and interpretation), and 74330 (Combined endoscopic catheterization of the biliary and pancreatic ductal systems, radiological supervision and interpretation).
  • CMS pay separately for CPT code 75893 (Venous sampling through catheter, with or without angiography (eg, for parathyroid hormone, rennin), radiological supervision and interpretation) if there are no separately payable OPPS services on the claim.
  • CMS continue to separately pay for CPT code 76000 (Fluoroscopy (separate procedures), up to one hour physician time, other than 71023 or 71024 (eg, cardiac fluoroscopy)).
  • CMS maintain the packaged status of CPT codes 76001 (Fluoroscopy, physician time more than one hour, assisting a non-radiologic physician (eg, nephrostolithotomy, ERCP, bronchoscopy, transbronchial biopsy)), 76003 (Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)), and 76005 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural, transforaminal epidural, subarachnoid, paravertebral fact joint, paravertebral facet joint nerve or sacroiliac joint), including neurolytic agent destruction).
  • CMS maintain the packaged status of CPT codes 76937 (Ultrasound guidance for vascular access requiring ultrasound evaluation of potential access sites, documentation of selected vessel patency, concurrent realtime ultrasound visualization of vascular needle entry, with permanent recording and reporting) and 75998 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal (includes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast injections through access site or catheter with related venography radiologic supervision and interpretation, and radiographic documentation of final catheter position)).
  • CMS provide separate payment for CPT codes 94760 (Noninvasive ear or pulse oximetry for oxygen saturation; single determination), 94761 (Noninvasive ear or pulse oximetry for oxygen saturation; multiple determinations), and 94762 (Noninvasive ear or pulse oximetry for oxygen saturation by continuous overnight monitoring) if there are no separately payable OPPS services on the claim.
  • CMS pay separately for CPT code 96523 (Irrigation of implanted venous access device for drug delivery systems) if there are no separately payable OPPS services on the claim.
  • CMS maintain the packaged status of HCPCS code G0269 (Placement of occlusive device into either a venous or arterial access site).
  • CMS pay separately for HCPCS code P9612 (Catheterization for collection of specimen, single patient) if there are no separately payable OPPS services on the claim.
  • CMS bring data to the next APC Panel meeting that show the following: (a) how the costs of packaged items and services are incorporated into the median costs of APCs and (b) how the costs of these packaged items and services influence payments for associated procedures.
  • The Packaging Subcommittee continue until the next APC Panel meeting.

At its August 2006 meeting, the Packaging Subcommittee further discussed the packaging status of several of the HCPCS codes described above and reported its findings to the APC Panel. The APC Panel accepted the report of the Packaging Subcommittee, heard one presentation, reviewed one written comment, and discussed the deliberations of the Packaging Subcommittee. The APC Panel made the following recommendations for CY 2007:

+ That CMS package new CPT codes 0174T, Computer aided detection (CAD) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed concurrent with primary interpretation (List separately in addition to code for primary procedure), and 0175T, Computer aided detection (CAD ) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed remote from primary interpretation).

+ That CMS continue to package revised CPT code 0069T (Acoustic heart sound recording and computer analysis; acoustic heart sound recording and computer analysis only).

+ That CMS assign CPT code 96523 (Irrigation of implanted venous access device for drug delivery systems) status indicator “Q” as a “special” packaged code.

For CY 2007, we proposed to maintain CPT code 0069T as a packaged service and not adopt the APC Panel's March 2006 recommendation to pay separately for this code. The service uses signal processing technology to detect, interpret, and document acoustical activities of the heart through special sensors applied to a patient's chest. This code was a new Category III CPT code implemented in the CY 2005 OPPS and assigned a new interim status indicator of “N” in the CY 2005 OPPS final rule with comment period. The APC Panel recommended packaging CPT code 0069T for CY 2006, and we accepted that recommendation when we finalized the status indicator “N” assignment to 0069T for CY 2006. CPT code 0069T is an add-on code to an electrocardiography (ECG) service for CYs 2005 and 2006. However on July 1, 2006, the AMA released to the public a code descriptor change to remove the add-on code designation for CPT code 0069T. The effective date of this change is January 1, 2007, at which point the descriptor will be “Acoustic heart sound recording and computer analysis; acoustic heart sound recording and computer analysis only.” We do not include Category III CPT codes that are released in July of a given year in the OPPS proposed rule for the following calendar year because of timing restraints. We include these codes in the OPPS final rule where they are assigned interim comment indicator “NI” to denote that they are open for public comment.

In its March 2006 presentation to the APC Panel, a manufacturer requested that we pay separately for CPT code 0069T and assign it to APC 0099 (Electrocardiograms), based on its estimated cost and clinical characteristics. The manufacturer stated Start Printed Page 67993that the acoustic heart sound recording and analysis service may be provided with or without a separately reportable electrocardiogram. Members of the APC Panel engaged in extensive discussion of clinical scenarios as they considered whether CPT code 0069T could or could not be appropriately reported alone or in conjunction with several different procedure codes.

During the August 2006 meeting, the Packaging Subcommittee further discussed CMS's proposal to package CPT 0069T for CY 2007 and the CY 2007 code descriptor change, and ultimately recommended to the APC Panel that CMS continue to package this code for CY 2007. The APC Panel accepted this recommendation.

Comment: One commenter requested that CMS pay separately for CPT code 0069T for CY 2007, mapping the code to an APC paying between $63 and $97. The commenter clarified that this service is sometimes provided with an ECG and sometimes provided without an ECG, according to its revised descriptor for CY 2007. The commenter could not explain the low median cost that was calculated from the claims data, but suggested that the nine claims used to calculate the median were miscoded. The commenter estimated the cost of the service to be approximately $80 per procedure, significantly higher than the median cost for APC 0099 (Electrocardiograms), which was $23.60 based on the CY 2005 data that were used to calculate the CY 2007 proposed median costs. Though the commenter agreed that it would be rare for the acoustic heart sound procedure to be performed alone without any other OPPS services, the commenter disagreed that the procedure would be “associated” with other services. Instead, the commenter clarified that it could be provided with a broad range of services, such as an emergency department visit, clinic visit, chest x-ray, or ECG. In addition, the commenter did not expect this service to have a meaningful impact on the median costs of those services because acoustic heart services are expected to be provided infrequently, compared to the total number of emergency department and clinic visits, chest x-rays, and ECGs.

Response: Despite the change in add-on status for CPT code 0069T for CY 2007, based on the clinical uses that were described during the March 2006 APC Panel meeting and in the public comments, we believe that it is highly unlikely that CPT code 0069T would be performed in the hospital outpatient department as a sole service without other separately payable OPPS services. Payment for CPT code 0069T could always be packaged into payments for those other services. Therefore, we believe that CPT code 0069T is appropriately packaged because it would usually be closely linked to the performance of an ECG, and would rarely, if ever, be the only OPPS service provided to a patient. We understand that the commenter is clarifying that this service is not required to be provided in conjunction with an ECG. However, we continue to believe that it is likely that an ECG or other separately payable service would be performed on the patient in conjunction with the acoustic heart sound service. Therefore, we believe that it is appropriate to continue packaging CPT code 0069T for CY 2007. In addition, this service is estimated to require only minimal hospital resources. Using CY 2005 claims that have been updated with more recent CCRs, we had only nine single claims for CPT code 0069T, with a median line-item cost of $2.45, consistent with its low expected cost. Packaging payment for CPT code 0069T is consistent with the principles of a prospective payment system that provides payments for groups of services. To the extent that the acoustic heart sounding recording service may be more frequently provided in the future in association with ECGs or other OPPS services as its clinical indications evolve, we expect that its cost would also be increasingly reflected in the median costs for those other services, particularly ECG procedures.

After carefully considering all comments received, we are adopting the APC Panel's August 2006 recommendation to continue to package this code for CY 2007. Therefore we are finalizing our proposal without modification to maintain CPT code 0069T as a packaged service for CY 2007.

For CY 2007, we proposed to accept the APC Panel's recommendation to maintain the packaged status of CPT code 0152T. The service involves the application of computer algorithms and classification technologies to chest x-ray images to acquire and display information regarding chest x-ray regions that may contain indications of cancer. This code was a new Category III CPT code implemented in the CY 2006 OPPS and assigned a new interim status indicator of “NI” in the CY 2006 OPPS final rule with comment period. For CY 2006, the code is indicated as an add-on code to chest x-ray CPT codes, according to the AMA's CY 2006 CPT book. However, on July 1, 2006, the AMA released to the public an update that deletes code 0152T for CY 2007 and replaces it with two new Category III CPT codes, 0174T and 0175T. Effective January 1, 2007, the descriptor for CPT code 0174T will be “Computer aided detection (CAD) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed concurrent with primary interpretation (List separately in addition to code for primary procedure) and the descriptor for 0175T will be “Computer aided detection (CAD) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed remote from primary interpretation.”

As indicated above, we do not include Category III CPT codes that are released in July of a given year in the OPPS proposed rule for the following calendar year because of timing restraints. We include these codes in the OPPS final rule, where they are assigned new interim comment indicator “NI” to denote that they are open to comment.

In its March 2006 presentation to the APC Panel, before the AMA had released the CY 2007 changes to this code, the manufacturer requested that we pay separately for this service and assign it to a New Technology APC with a payment rate of $15, based on its estimated cost, clinical considerations, and similarity to other image post-processing services that are paid separately. We proposed to accept the APC Panel's recommendation to package CPT code 0152T for CY 2007.

In its August 2006 presentation to the APC Panel, after the AMA had released the CY 2007 code changes, the manufacturer requested that we assign both of these two new codes to a New Technology APC with a payment rate of $15. The APC Panel members discussed these codes extensively. They considered the possibility of treating CPT code 0175T as a “special” packaged code, thereby assigning payment to the code only when it was performed by a hospital without any other separately payable OPPS service also provided on the same day. They questioned the meaning of the word “remote” in the code descriptor for CPT code 0175T, noting that is was unclear as to whether “remote” referred to time, geography, or a specific provider. They thought it was likely that a hospital without a CAD system that performed a chest x-ray and sent the x-ray to another hospital for performance of the CAD would be providing the CAD service under arrangement and, therefore, would be providing at least one other Start Printed Page 67994service (chest x-ray) that would be separately paid. Thus, even in these cases, payment for the CAD service could be appropriately packaged. After significant deliberation, the Panel recommended that we package both of the new CPT codes, 0174T and 0175T, for CY 2007.

Comment: One commenter requested that CMS pay separately for CPT codes 0174T and 0175T, mapping them to New Technology APC 1492, with a payment rate of $15. The commenter indicated that there is no basis for believing that chest x-ray computer-aided detection (CAD) will increase the number of chest x-rays performed in the outpatient setting, because chest x-ray CAD is not a screening tool and should only be applied to chest x-rays that are suspicious for lung cancer. The commenter also indicated that separate resources are required for chest x-ray CAD that are not required for a standard chest x-ray. In addition, the commenter stated that chest x-ray CAD can be performed at a different time or location or by a different provider than the chest x-ray. In these cases, the commenter believed that separate payment would be appropriate. The commenter was concerned that if hospitals are not paid separately for this technology, they will not be able to provide it, thereby limiting beneficiary access to chest x-ray CAD.

Response: We agree with the APC Panel that packaged payment for chest x-ray CAD under a prospective payment methodology for outpatient hospital services is appropriate because of the close relationship of chest x-ray CAD to chest x-ray services and its projected modest cost. We do not believe that CPT code 0174T would ever be performed as a sole service without other separately payable OPPS services, based on the code definition as an add-on service performed concurrent with the primary interpretation of a chest x-ray. We believe that payment for CPT code 0174T is appropriately packaged into payment for the chest x-ray services it accompanies. Payment for chest x-rays is provided through APC 0260 (Level I Plain Film Except Teeth), with a CY 2007 median cost of $43.35. The median costs for the individual x-ray services that can be reported with the CAD technology range from $36.00 to $56.11, easily overlapping the modest additional costs of providing chest x-ray CAD services. Although CPT code 0175T applies to chest x-ray CAD that is “remote” from the primary interpretation, the definition of “remote” as used in the code descriptor is vague, with respect to time, geography, or a specific provider, so the circumstances in which it would be the only service provided by a hospital are also unclear. As discussed by the APC Panel if an x-ray were sent to another hospital for performance of the CAD, the CAD service would likely be provided under arrangement, in which case the hospital that performed the x-ray would bill for both the x-ray and the CAD service. It is unnecessary to treat CPT code 0175T as a “special” packaged code because generally the payment for the x-ray CAD would be bundled into the payment for the chest x-ray. While we have no costs from claims data because 0152T was a new CPT code for CY 2006, and 0174T and 0175T are new codes for CY 2007, we estimate that the CAD service requires only modest resources. We expect that a hospital's cost per chest x-ray CAD service would largely depend on the volume of CAD services provided. To the extent that CAD may be more frequently provided in the future to aid in the review of diagnostic chest x-rays as its clinical indications evolve, we expect that its cost would also be increasingly reflected in the median costs for chest x-ray procedures.

After carefully considering all public comments received on this proposal, we are accepting the APC Panel's August 2006 recommendation to package new CPT codes 0174T and 0175T for CY 2007 on an interim final basis.

For CY 2007, we proposed to accept the recommendation of the APC Panel and maintain the packaged status of CPT code 36500. As noted in the CY 2007 OPPS proposed rule (71 FR 49535) we have heard that CPT code 36500 is sometimes billed only with its corresponding radiological supervision and interpretation code, 75893, but with no other separately payable OPPS services. In those cases, the provider would not receive any payment. For CY 2006, we accepted the APC Panel's recommendation to package both CPT codes 36500 and 75893 and to examine claims data. Our initial review of several clinical scenarios submitted by the public seemed to suggest that other separately payable procedures, such as venography, would likely be billed on the same claim. Our claims data indicate that there are usually separately payable codes that are billed on claims with CPT codes 36500 and 75893. However, we acknowledge that these two codes may occasionally be provided without any separately payable procedures. In these uncommon instances, the provider historically has not received any payment under the OPPS. We also understand that there is a cost associated with registering a patient and providing these services. Using CY 2005 claims, we have approximately 200 single claims for CPT code 75893, with a median cost of $269.13. As proposed for CY 2007 and described below for “special” packaged codes, when CPT codes 36500 and 75893 are billed on a claim with no separately payable OPPS services, CPT code 75893 would become separately payable and would receive payment for APC 0668. In this circumstance, payment for CPT code 36500 would be packaged into the separate payment for CPT code 75893.

We received no public comments on our proposal. Therefore, we are finalizing our proposal to accept the APC Panel's recommendation to maintain the packaged status of CPT code 36500 without modification.

For CY 2007, we proposed to accept the APC Panel's recommendation and pay separately for CPT codes 36540, 36600, 38792, 75893, 94762, and 96523 when any of these codes appear on a claim with no separately payable OPPS services also reported for the same date of service. We will refer to this subset of codes as “special” packaged codes. We acknowledge that there is a cost to the hospital associated with registering and treating a patient, regardless of whether the specific service provided requires minimal or significant hospital resources. While we continue to believe that these “special” packaged codes are almost always provided along with a separately payable service, our claims analyses indicate that there are rare instances when one of these services is provided without another separately payable OPPS service on the claim for the same date of service. In these instances, providers do not currently receive any payment. Therefore, we proposed to provide payment for the “special” packaged codes listed above when they are billed on a claim without another separately payable OPPS service on the same date. When any of the “special” packaged codes are billed with other codes that are separately payable under the OPPS on the same date of service, the “special” packaged code would be treated as a packaged code, and the cost of the packaged code would be bundled into the costs of the other separately payable services on the claim. The payments that the provider receives for the separately payable services would include the bundled payment for the packaged code(s).

During the August 2006 APC Panel meeting, the APC Panel reviewed a request from the public to assign payment to CPT code 96523 when it appears on a claim with no separately payable OPPS services also reported for the same date of service. The Panel Start Printed Page 67995recommended that we treat CPT code 96523 as a “special” packaged code for CY 2007.

We have heard concerns from the public stating that they are unable to submit claims to CMS that report only packaged codes. We note that although these claims are processed by the OCE and are ultimately rejected for payment, they are received by CMS, and we have cost data for packaged services based upon these claims. However, we recognize that the data used in our analyses to assess the frequencies with which packaged services are provided alone and their median costs are somewhat limited. It is possible that an unknown number of hospitals chose not to submit claims to CMS when a packaged code(s) was provided without other separately payable services on their claims, realizing that they would not receive payment for those claims. While we have been told that some hospitals may bill for a low-level visit if a packaged service only is provided so that they receive some payment for the encounter, we note that providers should bill a low-level visit code in such circumstances only if the hospital provides a significant, separately identifiable low-level visit in association with the packaged service.

Through OCE logic, the PRICER would automatically assign payment for a “special” packaged service reported on a claim if there are no other services separately payable under the OPPS on the claim for the same date of service. In all other circumstances, the “special” packaged codes would be treated as packaged services. We assign status indicator “Q” to these “special” packaged codes to indicate that they are usually packaged, except for special circumstances when they are separately payable. Through OCE logic, the status indicator of a “special” packaged code would be changed either to “N” or to the status indicator of the APC to which the code is assigned for separate payment, depending upon the presence or absence of other OPPS services also reported on the claim for the same date. Table 3 included in the CY 2007 OPPS proposed rule (71 FR 49536) and shown below listed the proposed status indicators and APC assignments for these “special” packaged codes when they are separately payable. We note that the payment for these “special” packaged codes is intended to make payment for all of the hospital costs, which may include patient registration and establishment of a medical record, in an outpatient hospital setting even when no separately payable services are provided to the patient on that day.

In the case of a claim with two or more “special” packaged codes only reported on a single date of service, the PRICER would assign separate payment only to the “special” packaged code that would receive the highest payment. The other “special” codes would remain packaged and would not receive separate payment.

Comment: Many commenters complimented the Packaging Subcommittee for their efforts to improve payment under the OPPS. In addition, the commenters further commended the Packaging Subcommittee and CMS for proposing to provide payment for “special” packaged codes under certain circumstances. One commenter stated that “special” packaged codes further complicate an already complicated system and requested that CMS consistently either package a code or pay separately for a code, but not both.

Response: We appreciate the commenters' support and plan to continue working with the Packaging Subcommittee to review other packaged codes that are brought to our attention by the public. While we acknowledge that “special” packaged codes add a layer of complexity to a complicated payment system, we continue to believe that it is appropriate to assign payment to “special” codes under certain circumstances. We note the “special” packaged code policy should impose no additional reporting burden on hospital billing staff because the OCE is automatically programmed to assign payment when appropriate.

Comment: One commenter appreciated that CMS clarified that a hospital cannot bill a CPT E/M code simply because the hospital would like to receive payment for the packaged service that was provided. The commenter asked that CMS also clarify whether this applies only to packaged services, or if it also applies to a service for which there is no applicable HCPCS code. Another commenter noted that CMS is now contradicting Transmittal A-02-129, which states that hospitals can bill a low level clinic visit with CPT code 97602 (Removal of devitalized tissue from wound(s), non-selective debridement, without anesthesia (eg, wet-to-moist dressings, enzymatic, abrasion), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session) to receive payment.

Response: Providers should bill a low-level visit code only if the hospital provides a significant, separately identifiable visit from any other service provided. This general rule applies to any service provided by a hospital. As discussed below in section IX.A, we would expect that the hospital resources associated with a visit would be reflected in the hospital's internal guidelines used to select the level of reporting for the visit. The hospital should bill the clinic visit code that most appropriately describes the service provided. We acknowledge that Transmittal A-02-129 is based upon our past policy that a hospital could bill a low level visit code in addition to CPT code 97602, which was then packaged in CY 2003, at the time of the instruction. However, beginning in CY 2006 we have provided separate payment for CPT 97602 when it is performed as a nontherapy service in the hospital outpatient setting. Therefore, the instruction is no longer relevant and will be revised, because hospitals are now able to report and be paid for this wound care service with the most specific CPT code available. This OPPS payment policy for nontherapy, nonselective wound care services will continue for CY 2007. In circumstances where there is no applicable HCPCS code to describe a distinct service, hospitals should continue to report the most appropriate unlisted procedure or unlisted services CPT code. In summary, with respect to the billing of low level visit CPT codes, as described above, our current policy dictates that hospitals may only bill a low-level visit code if the hospital provides a significant, separately identifiable visit from any other service provided.

Comment: One commenter thanked CMS for clarifying that CMS receives claims with only packaged codes that may be used for data analysis. The commenter also stated that it hoped that the “special” packaged codes policy would convince its hospital billing department to submit claims with only packaged services on them, so that CMS would have cost data for these codes. Other commenters asked that CMS clarify that it receives claims with only packaged codes and no separately payable codes.

Response: We will clarify again that claims with only packaged codes are received and processed by the OCE. We can access cost data for all of the packaged codes on the claim. We encourage hospitals to continue to submit claims to CMS with only packaged codes because these submissions will allow us to continue to gather cost data for these codes, and help us determine whether it would be appropriate to add additional packaged codes to the “special” packaged codes list. Start Printed Page 67996

After carefully considering the public comments received, we are adopting without modification, our proposal to accept the APC Panel's March 2006 recommendation to treat CPT codes 36540, 36600, 38792, 75893, 94762, and 96523 as “special” packaged codes. We note that we also are adopting the APC Panel's August 2006 recommendation to treat CPT code 96523 as a “special” packaged code. The APC assignments for these codes are shown in Table 3 below. These codes are assigned status indicator “Q” in Addendum B to this final rule with comment period.

Table 3.—Status Indicators and APC Assignments for “Special” Packaged CPT Codes

CPT codeDescriptorCY 2007 APCStatus indicatorCY 2007 APC median
36540Collect blood, venous access device0624S$31.44
36600Arterial puncture; withdrawal of blood for diagnosis0035T12.22
38792Sentinel node identification0389S84.05
75893Venous sampling through catheter, with or without angiography, radiological supervision and interpretation0668S381.71
94762Noninvasive ear or pulse oximetry for oxygen saturation by continuous overnight monitoring0443X63.61
96523Irrigation of implanted venous access device0624S31.44

We will monitor and analyze the claims frequency and claims detail for situations in which these codes are billed alone and then separately paid. This will allow us to determine both which providers are billing these codes most often and under what circumstances these codes are billed and separately paid. We expect that hospitals scheduling and providing services efficiently to Medicare beneficiaries will continue to generally provide these minor services in conjunction with other medically necessary services.

For CY 2007, we proposed to accept the APC Panel's recommendation and maintain the packaged status of CPT codes 74328, 74329, and 74330. The AMA notes that these radiological supervision and interpretation codes should be reported with procedure CPT codes 43260-43272. In fact, our data indicate that these supervision and interpretation codes are billed with 43260-43272 more than 90 percent of the time, indicating their routine use. We believe that some providers may be concerned that although the payment for the endoscopic procedure includes the bundled payment for the supervision and interpretation performed by the radiology department, the payment for the comprehensive service may be directed to the hospital department that performed the endoscopic procedure, rather than to the radiology department. While we understand this concern, the OPPS pays hospital for services provided, and we believe that hospitals are responsible for attributing payments to hospital departments as they believe appropriate. We do not believe that packaging these radiological supervision and interpretation codes leads to inaccurate payments for the full hospital resources associated with endoscopic retrograde cholangiopancreatography procedures.

We received no public comments on our proposal. Therefore, we are adopting our proposal to accept the APC Panel's recommendation and maintain the packaged status of CPT codes 74328, 74329, and 74330 for CY 2007.

For CY 2007, we proposed to accept the APC Panel's recommendation to continue to package CPT codes 76001, 76003, and 76005 and to continue to pay separately for CPT code 76000. As noted in the CY 2007 proposed rule (71 FR 49536), we received a comment which stated that it was inconsistent to pay separately for CPT code 76000 but to package CPT code 76001, when CPT code 76001 appears to be a similar code, except that it is for a longer period of physician time. The Packaging Subcommittee believed that many of the claims that listed CPT code 76001 were erroneously billed, as many of the procedure codes that were billed with CPT code 76001 included fluoroscopy as an integral part of the procedure. In other cases, the Packaging Subcommittee noted that a procedure-specific fluoroscopy code should probably have been billed, instead of CPT code 76001. The Packaging Subcommittee believed that CPT code 76000 could often be provided as a sole service, with no other separately payable procedures. The Packaging Subcommittee recommended that CMS continue to pay separately for CPT code 76000, consistent with the AMA's definition of this code, which specifies that it is a separate procedure, and to continue to package CPT codes 76001, 76003, and 76005.

We received no public comments that objected to our proposal. Therefore, we are adopting our proposal, without modification, to accept the APC Panel's recommendation to continue to package CPT codes 76001, 76003, and 76005 and to continue to pay separately for CPT code 76000 for OPPS services furnished on or after January 1, 2007.

For CY 2007, we proposed to accept the APC Panel's recommendation to continue to package CPT codes 76937 and 75998. In the CY 2006 OPPS final rule with comment period (70 FR 68544 and 68545), we reviewed in detail the data related to these two codes and promised to share CY 2004 and early CY 2005 data with the Packaging Subcommittee. We reviewed current data with the Packaging Subcommittee, and it recommended that we continue to package these codes. In summary, we believe that these services would always be provided with another separately payable procedure, so their costs would be appropriately bundled with the definitive vascular access device procedures. We found that the costs for these guidance procedures are relatively low compared to the CY 2007 proposed payment rates for the separately payable services they most frequently accompany. If we were to unpackage CPT codes 76937 and 75998, the single bills available to develop median costs for vascular access device insertion services would be significantly reduced. Therefore, we proposed to continue to package both CPT codes 76937 and 75998 for CY 2007.

CPT code 75998 will be replaced with CPT code 77001, effective January 1, 2007. The code descriptor will remain the same.

Comment: Several commenters requested that CMS pay separately for CPT code 76937 because they believe that packaged payment creates a disincentive for use of this technology. Three commenters cited a June 2001 report published by the Agency for Healthcare Research and Quality that claims that use of ultrasound guidance reduced the relative risk for complications during a central venous Start Printed Page 67997catheter insertion. In addition, two commenters submitted claims data analyses that suggested that for those vascular access procedures that CPT code 76937 could be reported with, CPT code 76937 was reported, on average, only 14 percent of the time, with the greatest utilization rate no more than 25 percent. The commenters stated that these analyses confirmed that ultrasound guidance is not standard practice while performing vascular access procedures.

Response: We appreciate the data analyses submitted by the commenters. In fact, we published the results of our similar analysis in the CY 2006 final rule with comment period (70 FR 68544). To summarize our previous analysis, using CY 2004 single claims data, we determined that for the four most commonly billed venous access device insertion codes (CPT codes 36556, 36558, 36561, and 36569), one or more forms of guidance (fluoroscopic and/or ultrasound) were reported on 41 to 64 percent of the single claims utilized for ratesetting. Specifically, ultrasound guidance was reported from 16 to 34 percent of the time and fluoroscopic guidance was billed from 29 to 52 percent of the time. Thus, overall for these vascular access device insertion services, guidance was used in at least 41 percent of the single claim cases, a very significant portion of the time. We note that all of the commenters are specifically concerned about unpackaging CPT code 76937 and do not appear to be concerned with the packaged status of CPT 75998. In fact, the commenters' analyses only included ultrasound guidance and did not specify the number of venous access device insertions that involved fluoroscopic guidance. We believe that hospital staff choose whether to use no guidance or fluoroscopic guidance or ultrasound guidance on an individual basis, depending on the clinical circumstances of the vascular access device insertion procedure. We also note that the two commenters studied the frequency of CPT code 76937 when billed with CPT codes 36555-36585, which includes central venous access device insertions, repairs, and replacements. In fact, the study that the commenters reference indicates that ultrasound guidance is appropriate for central venous access device insertions. Interestingly, the data now show that 16 percent of all central venous access device insertions are billed with ultrasound guidance while only 2 percent of repairs and replacements are billed with ultrasound guidance. We believe that this indicates that it may be less useful to use ultrasound guidance in conjunction with central venous access device repairs and replacements. Our hospital claims data demonstrate that in CY 2004 guidance services were used frequently for the insertion of vascular access devices, and we have no evidence that patients lacked appropriate access to guidance services necessary for the safe insertion of vascular access devices in the hospital outpatient setting. To the extent that ultrasound guidance may be more frequently provided in the future in association with the insertions of venous access devices or other OPPS services, we expect that its cost would also be increasingly reflected in the median costs for those services.

Also in the CY 2006 final rule (FR 70 68544), we reported our analysis of claims data related to ultrasound guidance for vascular access device insertion procedures from another perspective. Rather than determining how often central venous access device insertions were billed with ultrasound guidance, we determined how often ultrasound guidance was billed with central venous access device insertions. The OPPS hospital claims data reviewed at that time revealed that out of the total instances of CPT code 76937 appearing on the claims used for setting payment rates for CY 2006, CPT code 76937 was billed with four separately payable codes for insertion of central venous access devices 84 percent of the time. This indicated, as might have been expected, that the costs for CPT code 76937 were typically packaged into payment for four CPT codes, 36566, 36558, 36561, and 36569, the most commonly billed codes under the OPPS for vascular access device insertion. Because we believe that ultrasound guidance would always be provided with another separately payable procedure, its costs would be appropriately bundled with the handful of vascular access device insertion procedures with which it is most commonly performed. In addition, packaging is also appropriate because the cost of ultrasound guidance is relatively low compared to the CY 2007 payment rates for the separately payable services it most frequently accompanies.

After carefully considering the public comments received, we are adopting our proposal without modification to accept the APC Panel's March 2006 recommendation to continue to package CPT codes 76937 and 77001, which replaces CPT code 75998.

For CY 2007, we proposed to accept the APC Panel's recommendation to continue to package HCPCS code G0269. This code should never be billed without another separately payable procedure. Recent data indicate that 94 percent of the time HCPCS code G0269 was billed with either CPT code 93510 (Left heart catheterization, retrograde, from the brachial artery, axillary artery or femoral artery; percutaneous) or 93526 (Combined right heart catheterization and retrograde left heart catheterization). In addition, the median cost of G0269 is low compared to the costs of the procedures with which it is typically associated.

We received no public comments on our proposal. Therefore, we are finalizing our proposal, without modification, to package HCPCS code G0269 for CY 2007.

For CY 2007, we proposed to continue packaging CPT codes 94760 and 94761 and not adopt the APC Panel's recommendation to provide separate payment for these services if there are no other separately payable OPPS services on the claim for the same date of service. Our data review revealed that these services are very frequently provided in the OPPS, with over 1.18 million claims in CY 2005 for the single pulse oximetry determination service and over 485,000 claims for the multiple determinations service. These high frequencies may actually be understated as both of these services are packaged codes, and we have been told that some hospitals may not report the HCPCS codes for services for which they receive no separate payments. Single and multiple pulse oximetry determinations are almost always provided in association with other services that are separately payable under the OPPS, into which their costs may be appropriately packaged. Specifically, OPPS hospital claims data revealed that out of the total instances of CPT code 94760 appearing on claims used for setting payment rates for this CY 2007 OPPS final rule with comment period, CPT code 94760 was billed only 4 percent of the time in association with no other separately payable OPPS services, with a median cost of $14. Using the same data, CPT code 94761 was billed only 7 percent of the time in association with no other separately payable OPPS services, with a median cost of $36. These pulse oximetry services have a relatively low cost compared with the OPPS services they frequently accompany. If we were to provide separate payment for these pulse oximetry determinations when performed as stand alone procedures by hospitals, we are concerned that hospitals would lose their incentive to provide these basic, low cost, and brief services as efficiently as possible, generally during the same encounters where they are providing other services to the same patients. We believe their Start Printed Page 67998appropriate provision as single services should be very rare. Therefore, for CY 2007 we proposed not to include these codes on the list of “special” packaged codes, so their payment would remain packaged in all circumstances.

We received no public comments on our proposal. Therefore, we are adopting our proposal to continue packaging CPT codes 94760 and 94761 and are not adopting the APC Panel's March 2006 recommendation to provide separate payment for these services if there are no other separately payable OPPS services on the claim for the same date of service.

For CY 2007, we proposed to assign status indicator “A” to HCPCS code P9612 and reject the APC Panel's recommendation to pay separately under the OPPS for this code when it is billed without any separately payable OPPS services. This code is currently payable on the clinical lab fee schedule. Its status indicator of “A” would provide payment for the service whenever it is billed, regardless of the presence or absence of other reported services. In addition, for consistency we are proposing to assign status indicator “A” to HCPCS code P9615 as it is also payable on the clinical lab fee schedule. In general, when a code is payable on the clinical lab fee schedule, we defer to that fee schedule and do not assign payment under the OPPS.

We received no public comments on our proposal. Therefore, we are adopting our proposal without modification to assign status indicator “A” to HCPCS code P9612 and reject the APC Panel's recommendation to pay separately under the OPPS for this code when it is billed without any separately payable OPPS services.

For CY 2007, we proposed to assign status indicator “N” to CPT code 0126T (Common carotid intima-media thickness (IMT) study for evaluation of atherosclerotic burden or coronary heart disease risk factor). We received one public comment on this proposal.

Comment: One commenter disagreed with our status indicator assignment of “N” for CPT code 0126T and stated that CMS should pay separately for the common carotid IMT procedure because this is often the sole service that is performed in the hospital outpatient setting. As clarified by the commenter, common carotid IMT is a standardized ultrasound procedure that enables physicians to safely and accurately measure and monitor atherosclerosis, which is the underlying cause of heart attacks and stroke. The commenter reported that this code became effective on January 1, 2006. According to the commenter, unlike certain other ultrasound procedures that must be provided with other services, common carotid IMT is a stand-alone diagnostic test because it requires special imaging of the arterial wall and quantitative analysis. The commenter further added that based on the CPT code book instruction for other carotid procedures (that is, CPT codes 93880 and 93882), CPT coding does not permit bundling of 0126T with other procedure codes. The commenter urged CMS to pay separately for common carotid IMT and assign this code to New Technology APC 1504—Level IV ($200-$300), with a payment rate of $250.

Response: We continue to believe that it would be unlikely for this code to be provided without any other separately payable services on the same day. However, we also think that the commenter's suggestion bears closer examination. Therefore, we will review this code with the Packaging Subcommittee of the APC Panel, as is our standard procedure for codes that we are asked to review during the comment period, and as we have previously done for the other services discussed above. We will discuss with the Packaging Subcommittee, on an ongoing basis, packaged procedures for which status indicator changes have been suggested by the public.

We note that the APC Panel Packaging Subcommittee remains active, and additional issues and new data concerning the packaging status of codes will be shared for its consideration as information becomes available. We continue to encourage submission of common clinical scenarios involving currently packaged HCPCS codes to the Packaging Subcommittee for its ongoing review. Additional detailed suggestions for the Packaging Subcommittee should be submitted to APCPanel@cms.hhs.gov, with “Packaging Subcommittee” in the subject line.

B. Payment for Partial Hospitalization

1. Background

Partial hospitalization is an intensive outpatient program of psychiatric services provided to patients as an alternative to inpatient psychiatric care for beneficiaries who have an acute mental illness. A partial hospitalization program (PHP) may be provided by a hospital to its outpatients or by a Medicare-certified community mental health center (CMHC). Section 1833(t)(1)(B)(i) of the Act provides the Secretary with the authority to designate the hospital outpatient services to be covered under the OPPS. The Medicare regulations at 42 CFR 419.21(c) that implement this provision specify that payments under the OPPS will be made for partial hospitalization services furnished by CMHCs. Section 1883(t)(2)(C) of the Act requires that we establish relative payment weights based on median (or mean, at the election of the Secretary) hospital costs determined by 1996 claims data and data from the most recent available cost reports. Payment to providers under the OPPS for PHPs represents the provider's overhead costs associated with the program. Because a day of care is the unit that defines the structure and scheduling of partial hospitalization services, we established a per diem payment methodology for the PHP APC, effective for services furnished on or after August 1, 2000. For a detailed discussion, we refer readers to the April 7, 2000 OPPS final rule with comment period (65 FR 18452).

Historically, the median per diem cost for CMHCs has greatly exceeded the median per diem cost for hospital-based PHPs and has fluctuated significantly from year to year while the median per diem cost for hospital-based PHPs has remained relatively constant ($200-$225). We believe that CMHCs may have increased and decreased their charges in response to Medicare payment policies. As discussed in more detail in section II.B.2. of the preamble of this final rule with comment period and in the CY 2004 OPPS final rule with comment period (68 FR 63470), we believe that some CMHCs manipulated their charges in order to inappropriately receive outlier payments.

In the CY 2003 OPPS update, the difference in median per diem cost for CMHCs and hospital-based PHPs was so great, $685 for CMHCs and $225 for hospital-based PHPs, that we applied an adjustment factor of .583 to CMHC costs to account for the difference between “as submitted” and “final settled” cost reports. By doing so, the CMHC median per diem cost was reduced to $384, resulting in a combined hospital-based and CMHC PHP median per diem cost of $273. As with all APCs in the OPPS, the median cost for each APC was scaled relative to the cost of a mid-level office visit and the conversion factor was applied. The resulting per diem rate for PHP for CY 2003 was $240.03.

In the CY 2004 OPPS update, the median per diem cost for CMHCs grew to $1,038, while the median per diem cost for hospital-based PHPs was again $225. After applying the .583 adjustment factor in the CY 2004 proposed rule to the median CMHC per diem cost, the median CMHC per diem cost was $605. Because the CMHC median per diem cost exceeded the Start Printed Page 67999average per diem cost of inpatient psychiatric care, we proposed a per diem rate for CY 2004 based solely on hospital-based PHP data. The proposed PHP per diem for CY 2004, after scaling, was $208.95. However, by the time we published the OPPS final rule with comment period for CY 2004, we had received updated CCRs for CMHCs. Using the updated CCRs significantly lowered the CMHC median per diem cost to $440. As a result, we determined that the higher per diem cost for CMHCs was not due to the difference between “as submitted” and “final settled” cost reports, but was the result of excessive increases in charges which may have been done in order to receive higher outlier payments. Therefore, in calculating the PHP median per diem cost for CY 2004, we did not apply the .583 adjustment factor to CMHC costs to compute the PHP APC. Using the updated CCRs for CMHCs, the combined hospital-based and CMHC median per diem cost for PHP was $303. After scaling, we established the CY 2004 PHP APC of $286.82.

For CY 2005, the PHP per diem amount was based on 12 months of hospital and CMHC PHP claims data (for services furnished from January 1, 2003, through December 31, 2003). We used data from all hospital bills reporting condition code 41, which identifies the claim as partial hospitalization, and all bills from CMHCs because CMHCs are Medicare providers only for the purpose of providing partial hospitalization services. We used CCRs from the most recently available hospital and CMHC cost reports to convert each provider's line-item charges as reported on bills, to estimate the provider's cost for a day of PHP services. Per diem costs were then computed by summing the line-item costs on each bill and dividing by the number of days on the bill.

In a Program Memorandum issued on January 17, 2003 (Transmittal A-03-004), we directed fiscal intermediaries to recalculate hospital and CMHC CCRs by April 30, 2003, using the most recently settled cost reports. Following the initial update of CCRs, fiscal intermediaries were further instructed to continue to update a provider's CCR and enter revised CCRs into the outpatient provider-specific file. Therefore, for CMHCs, we used CCRs from the outpatient provider-specific file.

In the CY 2005 OPPS update, the CMHC median per diem cost was $310 and the hospital-based PHP median per diem cost was $215. No adjustments were determined to be necessary and, after scaling, the combined median per diem cost of $289 was reduced to $281.33. We believed that the reduction in the CMHC median per diem cost indicated that the use of updated CCRs had accounted for the previous increase in CMHC charges, and represented a more accurate estimate of CMHC per diem costs for PHP.

For the CY 2006 OPPS final rule with comment period, we analyzed 12 months of the most current claims data available for hospital and CMHC PHP services furnished between January 1, 2004, and December 31, 2004. We also used the most currently available CCRs to estimate costs. The median per diem cost for CMHCs was $154, while the median per diem cost for hospital-based PHPs was $201. Based on the CY 2004 claims data, the average charge per day for CMHCs was $760, considerably greater than hospital-based per day costs but significantly lower than what it was in CY 2003 ($1,184). We believed that a combination of reduced charges and slightly lower CCRs for CMHCs resulted in a significant decline in the CMHC median per diem cost between CY 2003 and CY 2004.

Following the methodology used for the CY 2005 OPPS update, the CY 2006 OPPS update combined hospital-based and CMHC median per diem cost was $161, a decrease of 44 percent compared to the CY 2005 combined median per diem amount. We believed that this amount was too low to cover the cost for all PHPs.

Therefore, as stated in the CY 2006 OPPS final rule with comment period (70 FR 68548 and 68549), we considered the following three alternatives to our update methodology for the PHP APC for CY 2006 to mitigate this drastic reduction in payment for PHP services: (1) base the PHP APC on hospital-based PHP data alone; (2) apply a different trimming methodology to CMHC costs in an effort to eliminate the effect of data for those CMHCs that appeared to have excessively increased their charges in order to receive outlier payments; and (3) apply a 15-percent reduction to the combined hospital-based and CMHC median per diem cost that was used to establish the CY 2005 PHP APC. (We refer readers to the CY 2006 OPPS final rule with comment period for a full discussion of the three alternatives (70 FR 68548).) After carefully considering these three alternatives and all comments received on them, we adopted the third alternative for CY 2006. We adopted this alternative because we believed and continue to believe that a reduction in the CY 2005 median per diem cost would strike an appropriate balance between using the best available data and providing adequate payment for a program that often spans 5-6 hours a day. We believe that 15 percent is an appropriate reduction because it recognizes decreases in median per diem costs in both the hospital data and the CMHC data, and also reduces the risk of any adverse impact on access to these services that might result from a large single-year rate reduction. However, we adopted this policy as a transitional measure, and stated in the CY 2006 OPPS final rule with comment period that we would continue to monitor CMHC costs and charges for these services and work with CMHCs to improve their reporting so that payments can be calculated based on better empirical data, consistent with the approach we have used to calculate payments in other areas of the OPPS (70 FR 68548).

To apply this methodology for CY 2006, we reduced $289 (the CY 2005 combined unscaled hospital-based and CMHC median per diem cost) by 15 percent, resulting in a combined median per diem cost of $245.65 for CY 2006.

2. PHP APC Update for CY 2007

For CY 2007, we proposed to calculate the CY 2007 PHP per diem payment rate using the same update methodology that we adopted in CY 2006. That is, we proposed to apply an additional 15-percent reduction to the combined hospital-based and CMHC median per diem cost that was used to establish the CY 2006 per diem PHP payment.

As discussed in the CY 2007 OPPS proposed rule (71 FR 49538), we analyzed 12 months of data for hospital and CMHC PHP claims for services furnished between January 1, 2005, and December 31, 2005. We used the most currently available CCRs to estimate costs. Using these CY 2005 claims data, the median per diem cost for CMHCs was $165 and the median per diem cost for hospital-based PHPs was $209. Following the methodology used for the CY 2005 update, the CY 2007 combined hospital-based and CMHC median per diem cost is $172.

While the combined hospital-based and CMHC median per diem cost is about $10 higher using the CY 2005 data compared to the CY 2004 data ($172 compared to $161), we believe this amount is still too low to cover the cost for PHPs. As a result, we proposed the same policy we adopted for CY 2006—a 15-percent reduction applied to the current median cost. Therefore, to calculate the proposed PHP per diem rate for CY 2007, we applied an additional 15-percent reduction to the Start Printed Page 68000combined hospital-based and CMHC median per diem cost.

To calculate the proposed CY 2007 APC PHP per diem cost, we reduced $245.65 (the CY 2005 combined hospital-based and CMHC median per diem cost of $289 reduced by 15 percent) by 15 percent, which resulted in a proposed combined median per diem cost of $208.80.

We received numerous public comments in response to our proposal. A summary of the comments received and responses follow:

Comment: A number of commenters expressed concern about the magnitude of the reduction, particularly in light of last year's 15 percent reduction. The majority of commenters requested that CMS freeze the PHP rate at the CY 2006 level. Representatives of CMHCs argued that their costs are higher than those of hospitals, with most in the $300 to $400 range. Another commenter indicated that a per-day rate of $325 to $375 was more appropriate than the proposed amount. The commenters also suggested alternatives to calculating the PHP rate, such as including prior years' CMHC data trended forward based on medical inflation or market basket update. In addition, several patients were concerned that a 15-percent reduction in payment would negatively impact their ability to continue therapy.

Response: For this CY 2007 final rule with comment period, we analyzed 12 months of more current data for hospital and CMHC PHP claims for services furnished between January 1, 2005 and December 31, 2005. These claims data are more current because the data include claims paid through June 30, 2006. We also used the most currently available CCRs to estimate costs. Using these updated data, we recreated the analysis performed for the CY 2007 proposed rule to determine if the significant factors we used in determining the proposed PHP rate had changed. The median per diem cost for CMHCs increased $8 to $173, while the median per diem cost for hospital-based PHPs decreased $19 to $190. The CY 2005 average charge per day for CMHCs was $675 similar to the figure noted in the CY 2007 proposed rule ($673) but still significantly lower than what is noted for CY 2003 ($1,184).

Following the 15-percent reduction methodology used for the CY 2005 update, the combined hospital-based and CMHC median per diem cost would be $175, only slightly more than the figure noted in the CY 2007 proposed rule ($172). We continue to believe this amount is too low to cover the cost of PHPs. However, we believe that freezing the current rate would not reflect the downward trend in data. Although the data continue to show a low per diem cost for PHP, we believe that a transition to the reduced amount may be more appropriate to ensure access for the vulnerable population served in PHPs. We recognize that many CMHCs are located in areas affected by Hurricanes Katrina and Rita where access to intensive mental health treatment is now limited. We note that the median per diem cost for hospital-based PHPs, which has been in the $200 to $225 range since the OPPS was implemented, went from $201 in CY 2004 to $190 in CY 2005, a decrease of 5 percent. We believe this percentage decrease provides a valid transitional percentage measure reflecting the downward trend in PHP cost.

Therefore, for CY 2007, we are making a 5-percent reduction to the CY 2006 median per diem rate. This amount accounts for the downward direction of the data and addresses concerns about the magnitude of a 15-percent reduction in 1 year. To calculate the CY 2007 APC PHP per diem cost, we reduced $245.65 (the CY 2005 combined hospital-based and CMHC median per diem cost of $289 reduced by 15 percent) by 5 percent, which resulted in a combined per diem cost of $233.37. If the PHP per diem cost continues to be low in CY 2008, we expect to continue the transition of decreasing the PHP median per diem cost to an amount that is reflective of the PHP data.

Comment: The commenters requested that CMS better define how it is monitoring and working with CMHCs to improve their reporting.

Response: CMS has provided guidance to all providers, through transmittals and manuals. In addition, when necessary, CMS has worked closely with fiscal intermediaries to provide guidance to targeted PHP providers to improve reporting.

Comment: Several commenters stated that CMS has applied its own assumptions and methodology on a different basis to compute the PHP rate each year from CY 2003 to CY 2006. The commenters also stated that the only years CMS used the same method was CY 2006 and CY 2007, when CMS made a simple 15-percent reduction from the previous year's rate.

Response: We do not agree with the commenters' assessment of our methodology for computing the PHP median per diem cost. Although a 0.583 adjustment factor was applied to CMHC costs in the CY 2003 update, all other aspects of the methodology that the commenter referenced have been the same each year until CY 2006. We have consistently calculated the PHP median per diem cost by using combined hospital-based and CMHC median cost data and scaled the figure relative to the cost of a mid-level office visit and then applied the conversion factor. However, in CY 2006, the combined hospital-based and CMHC median cost data produced an amount we believed was so low that it would result in too large of a single year rate reduction that we modified our methodology by limiting this decrease to 15 percent.

Comment: One commenter replicated the CMS methodology and computed rates very close to the CY 2007 proposed per diem rate, as well as the separate median per diem costs for CMHCs and hospital-based PHPs. The commenter also created a 3-year rolling median cost that also resulted in a rate similar to the proposed PHP rate. However, the commenter recommended that CMS use the hospital-specific cost center CCR for partial hospitalization instead of the overall outpatient CCR to calculate PHP median costs. The commenter believed that CMS has understated the PHP median costs by not using the hospital-specific CCRs for partial hospitalization.

Response: We note that most hospitals do not have a cost center for partial hospitalization; therefore, we have used the CCR as specific to PHP as possible. The following link contains the Revenue Cost to Cost Center Crosswalk: http://www.cms.hhs.gov/​HospitalOutpatientPPS/​03_​crosswalk.asp#TopOfPage.

This crosswalk indicates how (and if) charges on a claim are mapped to a cost center for the purpose of converting charges to cost. One or more cost centers are listed for every revenue code that is used in the OPPS median calculations, starting with most specific, and ending with most general. CMS maps the revenue code to the most specific cost center with a provider-specific CCR. If the hospital does not have a CCR for any of the listed cost centers, the overall hospital CCR is the default. The PHP revenue centers are mapped to a Primary Cost Center 3550 “Psychiatric/Psychological Services.” If that cost center is not available, then the Secondary Cost Center is 6000 “Clinic.” We use the overall facility CCR for CMHCs because PHP is the CMHCs’ only Medicare cost and CMHCs do not have the same cost centers as hospitals. Therefore, for CMHCs, we use the CCR from the outpatient provider-specific file.

Comment: One commenter stated that its internal computations reflect PHP per diem costs of $262.82 for its facility. The commenter urged CMS to increase the CY 2006 PHP rate of $245.65 by 6.8 percent so that the commenter's Start Printed Page 68001program would break even. Another commenter questioned why CMS did not use actual cost report data to obtain true costs instead of estimating cost using CCRs applied to charges. A third commenter stated that CMS is required to include average costs for all providers and that CMS claims to utilize data representative of the mean of actual operating costs.

Response: We appreciate the commenter sharing its facility's per diem costs for its facility. However, PHP providers are paid under the OPPS. Under the OPPS, we generally determine rates based on median cost using charges from bill data and then estimate costs using CCRs. The OPPS is a PPS and will reflect generally the cost of providing services. A PPS may pay more or less than a provider's costs and is not a reasonable cost reimbursement system.

Comment: One commenter observed a decline of 19 percent in the number of hospital-based PHPs from CY 2003 to CY 2005 and a decline of 21 percent in the number of hospital-based PHP claims. The commenter expected further reductions in the number of hospital-based PHPs if CMS implements the proposed 15-percent rate cut in CY 2007.

Response: We do not believe this is an appropriate comparison because the commenter did not use the complete year of CY 2005 claims data. Rather, the commenter used CY 2005 claims processed through December 31, 2005. Using comparable CYs 2003 and 2005 data, (both CY 2003 and CY 2005 claims processed through June 30, 2004 and June 30, 2006, respectively), the declines are 11 percent and 5 percent, respectively. During the same time period, the number of CMHCs increased 13 percent and the number of CMHC PHP claims increased 36 percent. While there may have been fewer hospital-based PHPs, the number of CMHCs increased from 136 in CY 2003 to 179 in CY 2005. In CY 2005, CMHC and hospital-based PHPs combined provided 1.2 million days of PHP care, compared to approximately 0.8 million days of PHP care in CY 2003. We believe our payment rates continue to ensure adequate access to PHP care.

Comment: Several commenters suggested establishing a task force to develop a new rate methodology that captures all relevant data and reflects the actual costs to providers to deliver PHP services. The commenters recommended that the new ratesetting task force be composed of CMS staff and a diverse group of stakeholders that include front-line providers of PHP services and representatives from national industry organizations.

Response: We agree that the payment rate for PHP needs to be accurate and appropriate to sustain access to care. As we consider changes to the current methodology, we believe input from the industry is an important part of that process. Therefore, we welcome any input and information that the industry can provide about the costs of their programs and encourage providers to submit information on their costs. We note that any significant change in payment methodology would require a statutory change.

Comment: A few commenters stated that wage index adjustment does not accurately reflect the cost of labor in areas affected by Hurricanes Katrina and Rita.

Response: The hospital wage data used to compute the FY 2007 hospital wage index is from the FY 2003 hospital cost reports for all hospitals. This is the standard lag timeframe in determining the hospital wage index. It will be another 2 years before the FY 2005 data will be reflected in the FY 2009 hospital wage index. The wage index is a relative measure of differences in area hourly wage levels. It compares a labor market's average hourly wage to the national average hourly wage. To the extent that post-hurricane hospital labor costs are higher relative to the national average, the wage index will reflect the higher relative labor cost beginning when the FY 2005 data will be used in the FY 2009 IPPS hospital wage index (which will be applied to the CY 2009 OPPS rate year). In addition, the statutory authority for the OPPS wage index policy in section 1833(t)(2)(D) of the Act requires that wage adjustments be made in a budget neutral manner. Therefore, we cannot raise one wage area and still maintain budget neutrality.

Comment: A few commenters disagreed with the CMS approach to establishing the median per diem cost by summarizing the line-item costs on each bill and dividing by the number of days on the bills. The commenters indicated that this calculation can severely dilute the rate and penalize providers. The commenters stated that all programs are strongly encouraged by the fiscal intermediaries to submit all PHP service days on claims, even when the patient receives less than three services. They further stated that programs must report these days to be able to meet the 57 percent attendance threshold and avoid potential delays in the claim payment. The commenters were concerned that programs are only paid their per diem when three or more qualified services are presented for a day of service. The commenters stated that if only one or two services are assigned a cost and the day is divided into the aggregate data, the cost per day is significantly compromised and diluted. They claimed that even days that are paid but only have three services dilute the cost factors on the calculations.

Response: If a provider has charges on a bill for which they do not receive payment, this will be reflected in that provider's CCRs. This lower CCR will be applied to the larger charges and will result in the appropriate cost per diem. To gauge the effect that days with one or two services had on the per diem cost, we trimmed all days with less than three services, and the recalculated median per diem cost only increased by $4.00. As such, we do not believe the calculations are adversely affected by the inclusion of these days.

Comment: A few commenters expressed concern that their financial status is affected where States limit payment of beneficiary coinsurance if the amount of Medicare payment made to a provider exceeds the State's payment rate for PHP.

Response: This is a Medicaid issue and beyond the scope of this final rule.

Comment: With respect to the methodology used to establish the PHP APC amount, commenters were concerned that data from settled cost reports fails to include costs reversed on appeal. The commenters stated that there are inherent problems in using claims data from a different time period than the CCRs from settled cost reports. The commenters indicated this would artificially lower the computed median costs, even though when cost reports are settled, generally 2 years or more after the actual year of services, as the providers have operated on actual revenues of 80 percent of the per diem.

Response: We use the best available data in computing the APCs. We issued a Program Memorandum on January 17, 2003 directing fiscal intermediaries to update the CCRs on an on-going basis whenever a more recent full year cost report is available. In this way, we minimize the time lag between the CCRs and claims data and continue to use the best available data.

Comment: One commenter stated that administrative costs for CMHCs continue to be a major impediment to operating PHPs for Medicare beneficiaries. The commenter was concerned that Medicare does not cover transportation to and from programs and does not cover meals. The commenter stated that almost all programs offer transportation because in most cases Start Printed Page 68002Medicare beneficiaries with serious mental illnesses would not be able to access these programs without the transportation.

Response: The services that are covered as part of a PHP are specified in section 1861(ff) of the Act. Meals and transportation are specifically excluded under section 1861(ff)(2)(I) of the Act.

Comment: Several commenters summed the payment rate for four Group Therapy sessions (APC 0325) and requested that amount as the minimum for a day of PHP (that is, 4 × $66.40=$265.60). Another commenter presented two different typical days using proposed CY 2007 rates. Typical Day 1 had three Group Therapy sessions (CPT code 90853, APC 0325, 3 × $66.40) and one Individual Psychotherapy session (CPT code 90818, APC 0325, $105.68). The commenter priced Typical Day 1 at $304.88. Typical Day 2 had one Group Therapy session (CPT code 90853, APC 0325, $66.40), one Individual Psychotherapy session (CPT code 90818, APC 0323, $105.68), and one Family Therapy session (CPT code 90847, APC 0324, $135.95). The commenter priced Typical Day 2 at $308.03. Based on the commenter's presented material, the commenter stated that the typical days yield an average componentized rate of $306. The commenters questioned how CMS can set rates for APCs 0322 through 0325, yet are unable to determine a payment rate for a day that is comprised of a minimum of three to four of those services. Another commenter stated that CMS requires a minimum of four treatments per day to qualify for a day of PHP and the proposed per diem rate of $208.27 for PHP that is less than what CMS would pay for four Group Therapy sessions (4 × $66.40=$265.60).

Response: We do not believe this is an appropriate comparison. The commenter does not use the PHP APC, APC 0033. The payment rates for APC services cited by the commenter (APC 0323, APC 0324 and APC 0325) are not computed from PHP bills. As stated earlier, we used data from PHP programs (both hospitals and CMHCs) to determine the median cost of a day of PHP. PHP is a program of services where savings can be realized by hospitals and CMHCs over delivering individual psychotherapy services.

We structured the PHP APC (0033) as a per diem methodology in which the day of care is the unit that reflects the structure and scheduling of PHPs and the composition of the PHP APC consists of the cost of all services provided each day. Although we require that each PHP day include a psychotherapy service, we do not specify the specific mix of other services provided and our payment methodology reflects the cost per day rather than the cost of each service furnished within the day. We note that CMS does not require a minimum of four services.

Comment: One commenter requested that the same provisions given to rural hospital outpatient departments also be given to rural CMHCs.

Response: We believe the commenter may be referring to the statutory hold harmless provisions. Section 1833(t)(7)(D) of the Act authorizes such payments, on a permanent basis, for children's hospitals and cancer hospitals and, through CY 2005, for rural hospitals having 100 or fewer beds and SCHs in rural areas. Section 1866(t)(7)(D) of the Act does not authorize hold harmless payments to CMHC providers. Section 411 of Pub. L. 108-173 required CMS to determine the appropriateness of additional payments for certain rural hospitals. That authority also does not extend to CMHCs.

Comment: Representatives of several CMHCs claimed that their costs are higher because “hospitals can share and spread their costs to other departments.” The commenters believed that the CMHC patient acuity level is more intense than that for hospital patients because hospital outpatient departments need only provide one or two therapies, yet still receive the full PHP per diem.

Response: CMHCs are required to furnish an array of outpatient services including specialized outpatient services for children, the elderly, individuals with a serious mental illness, and residents of its service area who have been discharged from inpatient treatment. Accordingly, CMHCs have the same ability to share costs among its programs as needed. Further, we believe hospital costs in some areas, for example, capital and 24-hour maintenance costs, likely exceed CMHC costs.

Comment: A few commenters stated that hospitals that offer partial hospitalization services should not be penalized for the instability in data reporting of CMHCs. Another commenter requested that CMS require that CMHCs improve their reporting or have that provider group face economic consequences.

Response: We believe that hospital-based programs may have benefited from the inclusion of CMHC data, as generally the median calculated from hospital outpatient department PHPs was consistently far less then the median amount that is computed for CMHCs. We have also taken steps to better educate the CMHCs in the cost reporting requirements.

Comment: One commenter asked why there are no CMHCs shown in the impact statement. The commenter asked if this is required by regulation.

Response: CMHCs do not share the same characteristics as hospitals and do not fit into the traditional impact categories (like bed size). Therefore, we have not included them in the impact chart. As PHP is the only Medicare service CMHCs provide, the impact is the percentage change in the APC amount from year to year. Assuming that the number days of PHP provided by CMHCs stays the same as it was in CY 2005, the estimated impact on CMHCs as a result of the CY 2007 PHP payment rate compared to the CY 2006 PHP payment rate is a 5-percent decrease.

3. Separate Threshold for Outlier Payments to CMHCs

In the November 7, 2003 final rule with comment period (68 FR 63469), we indicated that, given the difference in PHP charges between hospitals and CMHCs, we did not believe it was appropriate to make outlier payments to CMHCs using the outlier percentage target amount and threshold established for hospitals. There was a significant difference in the amount of outlier payments made to hospitals and CMHCs for PHP. In addition, further analysis indicated that using the same OPPS outlier threshold for both hospitals and CMHCs did not limit outlier payments to high cost cases and resulted in excessive outlier payments to CMHCs. Therefore, for CYs 2004, 2005, and 2006, we established a separate outlier threshold for CMHCs. For CYs 2004 and 2005, we designated a portion of the estimated 2.0 percent outlier target amount specifically for CMHCs, consistent with the percentage of projected payments to CMHCs under the OPPS in each of those years, excluding outlier payments. For CY 2006, we set the estimated outlier target at 1.0 percent and allocated a portion of that 1.0 percent, 0.6 percent (or 0.006 percent of total OPPS payments), to CMHCs for PHP services. The CY 2006 CMHC outlier threshold is met when the cost of furnishing services by a CMHC exceeds 3.40 times the PHP APC payment amount. The CY 2006 OPPS outlier payment percentage is 50 percent of the amount of costs in excess of the threshold.

The separate outlier threshold for CMHCs became effective January 1, 2004, and has resulted in more commensurate outlier payments. In CY 2004, the separate outlier threshold for Start Printed Page 68003CMHCs resulted in $1.8 million in outlier payments to CMHCs. In CY 2005, the separate outlier threshold for CMHCs resulted in $0.5 million in outlier payments to CMHCs. In contrast, in CY 2003, more than $30 million was paid to CMHCs in outlier payments. We believe this difference in outlier payments indicates that the separate outlier threshold for CMHCs has been successful in keeping outlier payments to CMHCs in line with the percentage of OPPS payments made to CMHCs.

As discussed in section II.B.2. of this preamble, we believe the CY 2005 CMHC data produce median per diem cost too low to use for the CY 2007 partial hospitalization payment rate. Due to the continued volatility of the CMHC charge data, we proposed to maintain the existing outlier threshold for CMHCs for CY 2007 at 3.40 times the APC payment amount and the CY 2007 outlier payment percentage applicable to costs in excess of the threshold at 50 percent.

As noted in section II.G. of this preamble, for CY 2007, we proposed to continue our policy of setting aside 1.0 percent of the aggregate total payments under the OPPS for outlier payments. We proposed that a portion of that 1.0 percent, an amount equal to 0.25 percent of outlier payments and 0.0025 percent of total OPPS payments would be allocated to CMHCs for PHP service outliers. As discussed in section II.G. of this preamble, we again proposed to set a dollar threshold in addition to an APC multiplier threshold for OPPS outlier payments. However, because the PHP is the only APC for which CMHCs may receive payment under the OPPS, we would not expect to redirect outlier payments by imposing a dollar threshold. Therefore, we did not propose to set a dollar threshold for CMHC outliers. As noted above, we proposed to set the outlier threshold for CMHCs for CY 2007 at 3.40 percent times the APC payment amount and the CY 2007 outlier payment percentage applicable to costs in excess of the threshold at 50 percent.

We received no public comments on our proposal. As discussed in section II.G. of this preamble, using more recent data for this final rule with comment period, we set the target for hospital outpatient outlier payments at 1.0 of total OPPS payments. We allocate a portion of that 1.0 percent, an amount equal to 0.15 percent of outlier payments and 0.0015 percent of total OPPS payments to CMHCs for PHP service outliers. For CY 2007, we set the outlier threshold for CMHCs for CY 2007 at 3.40 percent times the APC payment amount and the CY 2007 outlier percentage applicable to costs in excess of the threshold at 50 percent.

C. Conversion Factor Update for CY 2007

Section 1833(t)(3)(C)(ii) of the Act requires us to update the conversion factor used to determine payment rates under the OPPS on an annual basis. Section 1833(t)(3)(C)(iv) of the Act provides that, for CY 2007, the update is equal to the hospital inpatient market basket percentage increase applicable to hospital discharges under section 1886(b)(3)(B)(iii) of the Act.

The hospital market basket increase for FY 2007 published in the IPPS final rule on August 18, 2006 is 3.4 percent (71 FR 48146), the same as the forecast published in the FY 2007 IPPS proposed rule on April 25, 2006 (71 FR 24148). To set the OPPS proposed conversion factor for CY 2007, we increased the CY 2006 conversion factor of $59.511, as specified in the November 10, 2005 final rule with comment period (70 FR 68551), by 3.4 percent.

In accordance with section 1833(t)(9)(B) of the Act, we further adjusted the conversion factor for CY 2006 to ensure that the revisions we are making to our updates for a revised wage index and expanded rural adjustment are made on a budget neutral basis. We calculated a budget neutrality factor of 0.999331979 for wage index changes by comparing total payments from our simulation model using the FY 2007 IPPS final wage index values as finalized to those payments using the current (FY 2006) IPPS wage index values. To reflect the inclusion of essential access community hospitals (EACHs) as rural SCHs (discussed in section II.F. of this preamble), we calculated an additional budget neutrality factor of 0.999975941 for the rural adjustment, including EACHs. For CY 2007, we estimate that allowed pass-through spending would equal approximately $65.6 million, which represents 0.21 percent of total OPPS projected spending for CY 2007. The final conversion factor also is adjusted by the difference between the 0.17 percent pass-through dollars set-aside in CY 2006 and the 0.21 percent estimate for CY 2007 pass-through spending. Finally, payments for outliers remain at 1.0 percent of total payments for CY 2007.

The market basket increase update factor of 3.4 percent for CY 2007, the required wage index budget neutrality adjustment of approximately 0.999331979, the adjustment of 0.04 percent for the difference in the pass-through set-aside, and the adjustment for the rural payment adjustment for rural SCHs, including rural EACHs, of 0.999975941 result in a standard conversion factor for CY 2007 of $61.468.

We received many public comments on the calculation of the proposed conversion factor updates for CY 2007 with regard to the proposal to reduce the CY 2007 conversion factor for failure to report the IPPS RHQDAPU data. These comments are addressed in section XIX. of this preamble. We received no other comments on the proposed conversion factor update for CY 2007.

D. Wage Index Changes for CY 2007

Section 1833(t)(2)(D) of the Act requires the Secretary to determine a wage adjustment factor to adjust, for geographic wage differences, the portion of the OPPS payment rate and the copayment standardized amount attributable to labor and labor-related cost. Since the inception of the OPPS, CMS policy has been to wage adjust 60 percent of the OPPS payment, based on a regression analysis that determined that approximately 60 percent of the costs of services paid under OPPS were attributable to wage costs. We did not propose to revise this policy for CY 2007 OPPS. See section II.H. of this final rule with comment period for a description and example of how the wage index for a particular hospital is used to determine the payment for the hospital.

This adjustment must be made in a budget neutral manner. As we have done in prior years, we proposed to adopt the IPPS wage indices and extend these wage indices to hospitals that participate in the OPPS but not the IPPS (referred to in this section as “non-IPPS” hospitals).

As discussed in section II.A. of this preamble, we standardize 60 percent of estimated costs (labor-related costs) for geographic area wage variation using the IPPS wage indices that are calculated prior to adjustments for reclassification to remove the effects of differences in area wage levels in determining the OPPS payment rate and the copayment standardized amount.

As published in the original OPPS April 7, 2000 final rule with comment period (65 FR 18545), OPPS has consistently adopted the final IPPS wage indices as the wage indices for adjusting the OPPS standard payment amounts for labor market differences. Thus, the wage index that applies to a particular hospital under the IPPS will also apply to that hospital under the OPPS. As initially explained in the September 8, 1998 OPPS proposed rule, we believed and continue to believe that Start Printed Page 68004using the IPPS wage index as the source of an adjustment factor for OPPS is reasonable and logical, given the inseparable, subordinate status of the hospital outpatient within the hospital overall. In accordance with section 1886(d)(3)(E) of the Act, the IPPS wage index is updated annually. In the CY 2007 OPPS proposed rule, in accordance with our established policy, we proposed to use the FY 2007 final version of these wage indices to determine the wage adjustments for the OPPS payment rate and copayment standardized amount that would be published in our final rule with comment period for CY 2007 which will include the finalized wage indices in effect through March 31, 2007, and those in effect on or after April 1, 2007, to accommodate the expiring reclassification provisions under section 508 of Pub. L. 108-173 to determine the wage adjustments for the OPPS payment rate and copayment standardized amount.

On May 17, 2006 (71 FR 28644), in response to a court order in Bellevue Hosp. Ctr. v. Leavitt, we published a second IPPS proposed rule that would revise the methodology for calculating the occupational mix adjustment for FY 2007. We proposed to replace in full the descriptions of the data and methodology that would be used in calculating the occupational mix adjustment discussed in the first FY 2007 IPPS proposed rule. The second proposed rule also states that, because of the collection of new occupational mix data, we would publish the FY 2007 occupational mix adjusted wage index tables and related impacts on the CMS Web site shortly after we published the FY 2007 IPPS final rule, and in advance of October 1, 2006. The weights and factors would also be published on the CMS Web site after the FY 2007 IPPS final rule, but in advance of October 1, 2006 (71 FR 28650). On October 11, 2006 (71 FR 59886), we published an IPPS notice in the Federal Register that, in part, finalized the adjusted occupational mix wage indices published in the FY 2007 IPPS final rule. Readers are directed to refer to the wage index tables that were published on the CMS Web site before October 1, 2006.

We note that the FY 2007 IPPS wage indices continue to reflect a number of changes implemented in FY 2005 as a result of the revised Office of Management and Budget (OMB) standards for defining geographic statistical areas, the implementation of an occupational mix adjustment as part of the wage index, and new wage adjustments provided for under Pub. L. 108-173. The following is a brief summary of the changes in the FY 2005 IPPS wage indices, continued for FY 2007, and any adjustments that we are applying to the OPPS for CY 2007. We refer the reader to the FY 2007 IPPS final rule (71 FR 48005 through 48028) for a detailed discussion of the changes to the wage indices. Readers should refer also to our IPPS notice published in the Federal Register on October 11, 2006, for finalized changes to the adjusted occupational mix wage indices and related issues (71 FR 59886). In this final rule with comment period, we are not reprinting the FY 2007 IPPS wage indices referenced in the discussion below, with the exception of the out-migration wage adjustment table (Addendum L of this final rule with comment period). We also refer readers to the CMS Web site for the OPPS at http://www.cms.hhs.gov/​providers/​hopps. At this Web site, the reader will find a link to the finalized FY 2007 IPPS wage indices tables.

1. The continued use of the Core Based Statistical Areas (CBSAs) issued by the OMB as revised standards for designating geographical statistical areas based on the 2000 Census data, to define labor market areas for hospitals for purposes of the IPPS wage index. The OMB revised standards were published in the Federal Register on December 27, 2000 (65 FR 82235), and OMB announced the new CBSAs on June 6, 2003, through an OMB bulletin. In the FY 2005 IPPS final rule, CMS adopted the new OMB definitions for wage index purposes. In the FY 2007 IPPS final rule, we again stated that hospitals located in MSAs will be urban and hospitals that are located in Micropolitan Areas or outside CBSAs will be rural. To help alleviate the decreased payments for previously urban hospitals that became rural under the new geographical definitions, we allowed these hospitals to maintain for the 3-year period from FY 2005 through FY 2007, the wage index of the MSA where they previously had been located. To be consistent with the IPPS, we will continue the policy we began in CY 2005 of applying the same urban-to-rural transition to non-IPPS hospitals paid under the OPPS. That is, we would maintain the wage index of the MSA where the hospital was previously located for purposes of determining a wage index for CY 2007. Beginning in FY 2008, the 3-year transition will end and these hospitals will receive their statewide rural wage index. However, hospitals paid under the IPPS will be eligible to apply for reclassification.

For the occupational mix adjustment, we refer readers to the FY 2007 IPPS final rule and the October 11, 2006 IPPS notice discussed above. Under that final rule, the wage indices are adjusted 100 percent for occupational mix. In addition, as stated above, the finalized version of the FY 2007 IPPS wage index tables and other adjustment factors were published in the October 11, 2006 IPPS notice and are applicable to discharges occurring on or after October 1, 2006.

As noted above, for purposes of estimating an adjustment for the OPPS payment rates to accommodate geographic differences in labor costs in this final rule with comment period, we have used the finalized FY 2007 IPPS wage indices identified in the October 11, 2006 IPPS notice that are fully adjusted for differences in occupational mix using the new survey data, effective October 1, 2006. As proposed, in all cases, we are using the finalized FY 2007 IPPS wage indices, which include the wage indices to be in effect through March 31, 2007, and those to be in effect on or after April 1, 2007, with any subsequent corrections, for calculating OPPS payment in CY 2007.

2. The reclassifications of hospitals to geographic areas for purposes of the wage index. For purposes of the OPPS wage index, we proposed to adopt all of the IPPS reclassifications for FY 2007, including reclassifications that the Medicare Geographic Classification Review Board (MGCRB) approved under the one-time appeal process for hospitals under section 508 of Pub. L. 108-173. We note that section 508 reclassifications will terminate March 31, 2007, and that this expiration, along with the calendar year operating period of OPPS, impacts the calculation of the OPPS payment and the budget neutrality adjustment for the wage index. In the FY 2007 IPPS final rule (71 FR 48024 and 48025), we finalized the procedural rules for hospitals that wished to reclassify for the second half of FY 2007 (April 1, 2007, through September 30, 2007) under section 1886(d)(10) of the Act. These rules essentially provided procedures for some hospitals to retain section 508 reclassifications for the first half of FY 2007 and also be eligible to maintain an approved reclassification under section 1886(d)(10) for the second half of FY 2007. Rather than calculating one wage index that reflected all final reclassification adjustments, we will calculate two separate wage indices for FY 2007, one to be in effect October 1 through March 31, 2007, and one to be in effect April 1 through September 30, 2007.

These procedural rules also impact a hospital's eligibility to receive the out-migration wage adjustment, discussed Start Printed Page 68005in greater detail in section III.I. of the FY 2007 IPPS final rule (71 FR 48026) and under section II.D.4. of this preamble. A hospital cannot receive an out-migration wage adjustment if it is reclassified under section 1886(d)(10) of the Act. Hospitals declining reclassification status for any part of the year become eligible to receive the out-migration wage adjustment if they are located in an adjustment county. We note that because the OPPS operates on a calendar year (January 1 through December 31) and not a fiscal year, the expiring reclassification status under section 508 of Pub. L. 108-173 results in different wage indices for OPPS for the first quarter of CY 2007 (January 1, 2007, through March 31, 2007) and the last three quarters of CY 2007 (April 1, 2007, through December 31, 2007).

3. The out-migration wage adjustment to the wage index. In FY 2007 IPPS final rule (71 FR 48026), we discussed the out-migration adjustment under section 505 of Pub. L. 109-173 for counties under this adjustment. Hospitals paid under the IPPS located in the qualifying section 505 “out-migration” counties receive a wage index increase unless they have already been otherwise reclassified. (See the IPPS FY 2007 final rule for further information on out-migration.) For OPPS purposes, we proposed to continue our policy from CY 2006 to allow non-IPPS hospitals paid under the OPPS to qualify for out-migration adjustment if they are located in a section 505 out-migration county. Because non-IPPS hospitals cannot reclassify, they are eligible for the out-migration wage adjustment. Tables identifying counties eligible for the out-migration adjustment were published after the FY 2007 IPPS final rule on October 11, 2006 (71 FR 59886). These tables reflect updated county listing to reflect changes to the occupation mix adjustment made in response to Bellevue court case discussed above. Because we proposed to adopt the final FY 2007 IPPS wage index, we are adopting any changes in a hospital's classification status that will make them either eligible or ineligible for the out-migration wage adjustment both through March 31, 2007, and on or after April 1, 2007.

With the exception of reclassifications resulting from the implementation of the one-time appeal process under section 508 of Pub. L. 108-173, all changes to the wage index resulting from geographic labor market area reclassifications or other adjustments must be incorporated in a budget neutral manner. Accordingly, in calculating the OPPS budget neutrality estimates for CY 2007, in this final rule with comment period, we have included the wage index changes that would result from MGCRB reclassifications, implementation of section 505 of Pub. L. 108-173, and other refinements made in the FY 2007 IPPS final rule, such as the hold harmless provision for hospitals changing status from urban to rural under the new CBSA geographic statistical area definitions. However, section 508 sets aside $900 million to implement the section 508 reclassifications. We considered the increased Medicare payments that the section 508 reclassifications would create in both the IPPS and OPPS when we determined the impact of the one-time appeal process. Because the increased OPPS payments already count against the $900 million limit, we did not consider these reclassifications when we calculated the OPPS budget neutrality adjustment.

Under the procedural rules described under section II.D.3. of this final rule with comment period and in section III.H.6. of the FY 2007 IPPS final rule (71 FR 48024) regarding expiring section 508 reclassifications, different wage indices may be in effect for the first quarter of the calendar year and the last three quarters of the calendar year. These rules have implications for budget neutrality adjustments. Any additional payment attributable to reclassifications due to section 508 between January 1 and April 1, 2007, must be excluded from a budget neutrality adjustment, and all other adjustments to the wage index are subject to budget neutrality. Rather than calculating two different conversion factors, with different budget neutrality adjustments, we proposed to calculate one budget neutrality adjustment that reflects the combined adjustments required for the first quarter and last three quarters of the calendar year, respectively. We followed the same approach in the FY 2007 IPPS final rule (71 FR 48026).

We received several comments on the proposed wage index policy for the CY 2007 OPPS.

Comment: One commenter urged CMS to use the IPPS labor-related adjustment to determine reimbursements for outpatient services. Specifically, the commenter requested that the labor-related percentage for the OPPS be revised from the 60 percent currently proposed to 69.7 percent, consistent with what is stated in the FY 2007 IPPS rule. The commenter further requested that, at a minimum, CMS update the OPPS labor-related share in effect for CY 2007 from 60 percent to 63 percent, the labor-related percentage referenced by CMS in the CY 2006 OPPS final rule.

Response: We did not propose a change to the labor share, but we do not believe that such a change is appropriate. The determination to wage adjust 60 percent of the payment of each APC was made based on a regression analysis at the beginning of the OPPS. We repeated this analysis as part of the rural adjustment study we performed for the CY 2006 OPPS based on CY 2004 claims data. This study examined the extent to which the body of costs for services furnished in the outpatient department was split between wage and nonwage costs and, based on our most recent findings, we believe that it remains appropriate to wage adjust 60 percent of the APC payment (70 FR 68533).

Comment: One commenter urged CMS to postpone the implementation of 100 percent of the occupational mix survey adjustment until the DRG severity refinements can be fully implemented and their possible unrecognized adverse effects on quality of care and outcomes can be resolved. Another commenter expressed concern about the application of the 100-percent occupational mix adjustment for CY 2007. The commenter encouraged CMS to approach Congress for authority to transition the occupational mix and to repeal the mandate that CMS apply an occupational mix adjustment to wage indices.

Response: We appreciate the comments concerning this issue and refer readers to the CMS final rule for the CY 2007 IPPS ( 71 FR 48006) for a discussion of the reasons that CMS adopted a 100 percent occupational mix adjusted wage index for hospitals receiving payments under the IPPS. As first published in the original OPPS final rule on April 7, 2000 (65 FR 18545), the OPPS has consistently adopted the final IPPS wage indices as the wage indices for adjusting the OPPS standard payment amounts for labor market differences. We continue to believe that using the IPPS wage index as the source of an adjustment factor for the OPPS is reasonable and logical given the inseparable, subordinate status of the hospital outpatient department within the hospital overall. Therefore, given that a 100 percent occupational mix adjusted wage index was adopted in the IPPS, we will also adopt the same index for the OPPS.

After carefully considering all public comments received, we are finalizing our wage index adjustment policy for the CY 2007 OPPS as proposed without modification. Start Printed Page 68006

E. Statewide Average Default CCRs

CMS uses CCRs to determine outlier payments, payments for pass-through devices, and monthly interim transitional corridor payments under the OPPS. Some hospitals do not have a valid CCR. These hospitals include, but are not limited to, hospitals that are new and have not yet submitted a cost report, hospitals that have a CCR that falls outside predetermined floor and ceiling thresholds for a valid CCR, or hospitals that have recently given up their all-inclusive rate status. Last year, we updated the default urban and rural CCRs for CY 2006 in our final rule with comment period published on November 10, 2005 (70 FR 68553 through 68555). As we proposed, in this final rule with comment period, we have updated the default ratios for CY 2007 using the most recent cost report data.

We calculated the statewide default CCRs using the same overall CCRs that we use to adjust charges to costs on claims data. Refer to section II.A.1.c. of this preamble for a discussion of our revision to the overall CCR calculation. Table 4 published in the CY 2007 OPPS proposed rule listed the proposed CY 2007 default urban and rural CCRs by State and compared them to last year's default CCRs (71 FR 49542 through 49545). These CCRs are the ratio of total costs to total charges from each provider's most recently submitted cost report, for those cost centers relevant to outpatient services weighted by Medicare Part B charges. We also adjusted these ratios to reflect final settled status by applying the differential between settled to submitted costs and charges from the most recent pair of settled to submitted cost reports.

For the proposed rule, 81.79 percent of the submitted cost reports represented data for CY 2004. We have since updated the cost report data we use to calculate CCRs with additional submitted cost reports for CY 2005. For this final rule with comment period, 66.41 percent of the submitted cost reports utilized in the default ratio calculation were for CY 2004, whereas 34.95 percent were for CY 2005. We only used valid CCRs to calculate these default ratios. That is, we removed the CCRs for all-inclusive hospitals, CAHs, and hospitals in Guam and the U.S. Virgin Islands because these entities are not paid under the OPPS, or in the case of all-inclusive hospitals, because their CCRs are suspect. We further identified and removed any obvious error CCRs and trimmed any outliers. We limited the hospitals used in the calculation of the default CCRs to those hospitals that billed for services under the OPPS during CY 2004.

Finally, we calculated an overall average CCR, weighted by a measure of volume for CY 2004, for each State except Maryland. This measure of volume is the total lines on claims and is the same one that we use in our impact tables. For Maryland, we used an overall weighted average CCR for all hospitals in the Nation as a substitute for Maryland CCRs. Very few providers in Maryland are eligible to receive payment under the OPPS, which limits the data available to calculate an accurate and representative CCR. The observed differences between last year's default statewide CCRs and the CY 2007 CCRs are a combination of the general decline in the ratio between costs and charges widely observed in the cost report data and the change in the proposed overall CCR calculation.

As stated above, CMS uses default statewide CCRs for several groups of hospitals, including, but not limited to, hospitals that are new and have not yet submitted a cost report, hospitals that have a CCR that falls outside predetermined floor and ceiling thresholds for a valid CCR, and hospitals that have recently given up their all-inclusive rate status. Current OPPS policy also requires hospitals that experience a change of ownership, but that do not accept assignment of the previous hospital's provider agreement, to use the previous provider's CCR.

For CY 2007, we proposed to apply this treatment of using the default statewide CCR to include an entity that has not accepted assignment of an existing hospital's provider agreement in accordance with § 489.18, and that has not yet submitted its first Medicare cost report. We proposed that this policy be effective for hospitals experiencing a change of ownership on or after January 1, 2007. We believed that a hospital that has not accepted assignment of an existing hospital's provider agreement is similar to a new hospital that will establish its own costs and charges. We believed that the hospital that has chosen not to accept assignment may have different costs and charges than the existing hospital. Furthermore, we believed that the hospital should be provided time to establish its own costs and charges. Therefore, we proposed to use the default statewide CCR to determine cost-based payments until the hospital has submitted its first Medicare cost report.

We did not receive any public comments concerning the proposed statewide average default CCR. Therefore, we are finalizing the statewide average default CCRs shown in Table 4 below for OPPS services furnished on or after January 1, 2007 without modification.

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F. OPPS Payments to Certain Rural Hospitals

1. Hold Harmless Transitional Payment Changes Made by Pub. L. 109-171 (DRA)

When the OPPS was implemented, every provider was eligible to receive an additional payment adjustment (transitional corridor payment) if the payments it received for covered OPD services under the OPPS were less than the payments it would have received for the same services under the prior reasonable cost-based system. Section 1833(t)(7) of the Act provides that the transitional corridor payments are temporary payments for most providers, with two exceptions, to ease their transition from the prior reasonable cost-based payment system to the OPPS system. Cancer hospitals and children's hospitals receive the transitional corridor payments on a permanent basis. Section 1833(t)(7)(D)(i) of the Act originally provided for transitional corridor payments to rural hospitals with 100 or fewer beds for covered OPD services furnished before January 1, 2004. However, section 411 of Pub. L. 108-173 amended section 1833(t)(7)(D)(i) of the Act to extend these payments through December 31, 2005, for rural hospitals with 100 or fewer beds. Section 411 also extended the transitional corridor payments to sole community hospitals (SCHs) located in rural areas for services furnished during the period that begins with the provider's first cost reporting period beginning on or after January 1, 2004, and ends on December 31, 2005. Accordingly, the authority for making transitional corridor payments under section 1833(t)(7)(D)(i) of the Act, as amended by section 411 of Pub. L. 108-173, expired for rural hospitals having 100 or fewer beds and SCHs located in rural areas on December 31, 2005.

Section 5105 of Pub. L. 109-171 reinstituted the hold harmless transitional outpatient payments (TOPs) for covered OPD services furnished on or after January 1, 2006, and before January 1, 2009, for rural hospitals having 100 or fewer beds that are not SCHs. When the OPPS payment is less than the payment the provider would have received under the previous reasonable cost-based system, the amount of payment is increased by 95 percent of the amount of the difference Start Printed Page 68010between those two payment systems for CY 2006, by 90 percent of the amount of that difference for CY 2007, and by 85 percent of the amount of that difference for CY 2008.

For CY 2006, we have implemented section 5105 of Pub. L. 109-171 through Transmittal 877, issued on February 24, 2006. We did not specifically address whether TOPs payments apply to essential access community hospitals (EACHs), which are considered to be SCHs under section 1886(d)(5)(D)(iii)(III) of the Act. Accordingly, under the statute, EACHs are treated as SCHs. Therefore, we believe that EACHs are not eligible for TOPs payment under Pub. L. 109-171. In the CY 2007 OPPS proposed rule, we proposed to update § 419.70(d) to reflect the requirements of Pub. L. 109-171.

2. Adjustment for Rural SCHs Implemented in CY 2006 Related to Pub. L. 108-173 (MMA)

In the CY 2006 OPPS final rule with comment period (70 FR 68556), we finalized a payment increase for rural SCHs of 7.1 percent for all services and procedures paid under the OPPS, excluding drugs, biologicals, brachytherapy seeds, and services paid under pass-through payment policy in accordance with section 1833(t)(13)(B) of the Act, as added by section 411 of Pub. L. 108-173. Section 411 gave the Secretary the authority to make an adjustment to OPPS payments for rural hospitals, effective January 1, 2006, if justified by a study of the difference in costs by APC between hospitals in rural and urban areas. Our analysis showed a difference in costs only for rural SCHs and we implemented a payment adjustment for those hospitals beginning January 1, 2006.

As indicated in the CY 2007 OPPS proposed rule (71 FR 49547), we recently became aware that we did not specifically address whether the adjustment applies to EACHs, which are considered to be SCHs under section 1886(d)(5)(D)(iii)(III) of the Act. Thus, under the statute, EACHs are treated as SCHs. Currently, fewer than 10 hospitals are classified as EACHs. As of CY 1998, under section 4201(c) of Pub. L. 105-33, a hospital can no longer become newly classified as an EACH. Therefore, for purposes of receiving this rural adjustment, we are clarifying that EACHs are treated as SCHs for purposes of receiving this adjustment, assuming these entities otherwise meet the rural adjustment criteria.

This adjustment is budget neutral and applied before calculating outliers and coinsurance. We also stated that we would not reestablish the adjustment amount on an annual basis, but that we might review the adjustment in the future and, if appropriate, would revise the adjustment. For CY 2007, we proposed to continue our current policy of a budget neutral 7.1 percent payment increase for rural SCHs for specified services.

Comment: Many commenters expressed concern that small rural hospitals will suffer financially if TOPs payments continue to decrease each year, as specified in section 5105 of Pub. L. 109-171. The commenters noted that patient access to small rural hospitals could be at risk. One commenter supported permanent TOPs for rural SCHs, which currently do not receive any TOPs payments. Several commenters noted their support for a Senate bill, S.3606, which is known as the “Save our Safety Net Act of 2005.”

Response: We share the concerns of rural hospitals and do not intend to limit access to health care for Medicare beneficiaries in rural areas. However, we note that the statute is very specific and does not provide TOPs payments for entities other than those listed in the statute. The statute also requires TOPs payments to gradually decrease through CY 2008.

Comment: Several commenters requested that CMS clarify that the 7.1 percent rural SCH adjustment applies to EACHs retroactive to January 1, 2006.

Response: As stated above, we are clarifying that EACHs are treated as SCHs for purposes of receiving this adjustment, assuming these entities otherwise meet the rural adjustment criteria. EACHs are eligible for this adjustment effective January 1, 2006, as are all rural SCHs. As stated above, we agree with the commenters and are revising § 419.43(g) to specifically reflect this clarification. In addition, we will ensure that a retroactive payment adjustment occurs.

Comment: Several commenters supported the 7.1 percent adjustment for rural SCHs for CY 2007, but requested that CMS rerun the analyses to possibly provide for an adjustment for other rural hospitals during CY 2008 and CY 2009, when TOPs payments will be further reduced.

Response: As stated above, while we will not reestablish the adjustment amount nor determine whether other rural hospitals are eligible for the adjustment on an annual basis, we may review the adjustment in the future and, if appropriate, would revise the adjustment.

After carefully considering the comments received, we are finalizing our policy by continuing a payment adjustment for rural SCHs, including EACHs, of 7.1 percent and finalizing the regulation text at § 419.70(d) without modification. We are also revising § 419.43(g) to clarify that EACHs are also eligible for the rural SCH OPPS adjustment.

G. CY 2007 Hospital Outpatient Outlier Payments

Currently, the OPPS pays outlier payments on a service-by-service basis. For CY 2006, the outlier threshold is met when the cost of furnishing a service or procedure by a hospital exceeds 1.75 times the APC payment amount and exceeds the APC payment rate plus a $1,250 fixed-dollar threshold. We introduced a fixed-dollar threshold in CY 2005 in addition to the traditional multiple threshold in order to better target outliers to those high cost and complex procedures where a very costly service could present a hospital with significant financial loss. If a provider meets both of these conditions, the multiple threshold and the fixed-dollar threshold, the outlier payment is calculated as 50 percent of the amount by which the cost of furnishing the service exceeds 1.75 times the APC payment rate. For a discussion on CMHC outliers, see section II.B.3. of the preamble to this final rule with comment period.

As explained in the CY 2006 OPPS final rule with comment period (70 FR 68561), we set our projected target for aggregate outlier payments at 1.0 percent of aggregate total payments under the OPPS. The outlier thresholds were set so that estimated CY 2006 aggregate outlier payments would equal 1.0 percent of aggregate total payments under the OPPS. In the CY 2006 OPPS final rule with comment period (70 FR 68563), we also published total outlier payments as a percent of total expenditures for past years. However, when we published the CY 2007 OPPS proposed rule, we did not have a complete set of CY 2005 claims data to produce this number for CY 2005 and stated that we would report on CY 2005 outlier payments in this CY 2007 OPPS final rule with comment period. In the final set of CY 2005 OPPS claims, aggregated outlier payments were 2.39 percent of aggregated total OPPS payments. For CY 2005, the estimated outlier payments were set at 2 percent of the total aggregated OPPS payments. Therefore, for CY 2005, we paid 0.39 percent in excess of the CY 2005 outlier target of 2 percent of total aggregated OPPS payments.

1. CY 2007 Proposal

For CY 2007, we proposed to continue our policy of setting aside 1.0 percent of Start Printed Page 68011aggregate total payments under the OPPS for outlier payments. We proposed that a portion of that 1.0 percent would be allocated to CMHCs for partial hospitalization program service outliers. We proposed that the portion allocated to CMHCs would be determined by the amount of estimated outlier payments resulting from the CMHC outlier threshold.

In order to ensure that estimated CY 2007 aggregate outlier payments would equal 1.0 percent of estimated aggregate total payments under the OPPS, we proposed that the outlier threshold be set so that outlier payments would be triggered when the cost of furnishing a service or procedure by a hospital exceeds 1.75 times the APC payment amount and exceeds the APC payment rate plus a $1,825 fixed-dollar threshold.

We calculated the fixed-dollar threshold for the CY 2007 proposed rule using the same methodology as we did in CY 2006, except we used the revised overall CCR calculation discussed in section II.A.1.c. of this preamble. As discussed in section II.A.1.c. of this preamble, we discovered that the calculation of the overall CCR that the fiscal intermediaries are using to determine outlier payment and payment for services paid at charges reduced to cost differs from the overall CCR that we traditionally use to model the outlier thresholds. We discovered this during our calculations of the outlier threshold for the CY 2006 OPPS final rule with comment period, and we indicated in our preamble discussion for that rule, that we might revisit the threshold estimate methodology in light of identified differences in the overall CCR calculation. Because, on average, the overall CCR calculation used by the fiscal intermediaries results in higher CCRs than those estimated using our “traditional” CCR sets, the outlier threshold calculated for the CY 2006 OPPS final rule with comment period is too low. The OPPS impact table in section XXVII. of the CY 2007 proposed rule (Table 49; 71 FR 49687) demonstrated an estimated payment differential of 0.25 percent of total spending for hospital outlier payments in CY 2006 because of the differences in overall CCR calculations. The revised overall CCR calculation that we proposed for CY 2007 aligns the two CCR calculations by removing allied and nursing health costs for those hospitals with paramedical education programs from the fiscal intermediary's CCR calculation and weighting our “traditional” calculation by total Medicare Part B charges. We expected this proposed change in the overall CCR calculation to raise the outlier threshold.

2. CY 2007 Final Rule Outlier Calculation

The claims that we use to model each OPPS update lag by 2 years. For this final rule with comment period, we used CY 2005 claims to model the CY 2007 OPPS. In order to estimate CY 2007 outlier payments for this final rule with comment period, we inflated the charges on the CY 2005 claims using the same inflation factor of 1.1642 that we used to estimate the IPPS fixed-dollar outlier threshold for the FY 2007 IPPS final rule. For 1 year, the inflation factor is 1.079. The methodology for determining this charge inflation factor was discussed in the FY 2007 IPPS final rule (71 FR 48150). As we stated in the CY 2005 OPPS final rule with comment period, we believe that the use of this charge inflation factor is appropriate for the OPPS because, with the exception of the routine service cost centers, hospitals use the same cost centers to capture costs and charges across inpatient and outpatient services (69 FR 65845). As also noted in the FY 2006 IPPS final rule, we believe that a charge inflation factor is more appropriate than an adjustment to costs because this methodology closely captures how actual outlier payments are made and calculated (70 FR 47495). We then applied the revised overall CCR that we calculated from each hospital's most recent cost report (CMS-2552-96) and, if the cost report was not settled, we adjusted it by a settled-to-submitted ratio. We simulated aggregated outlier payments using these costs for several different fixed-dollar thresholds holding the 1.75 multiple constant until the total outlier payments equaled 1.0 percent of aggregated total OPPS payments. We estimate that a threshold of $1,825 combined with the multiple threshold of 1.75 times the APC payment rate would allocate 1.0 percent of aggregated total OPPS payments to outlier payments.

For CMHCs, in CY 2007 we are projecting that the outlier threshold is met when the cost of furnishing a service or procedure by a CMHC exceeds 3.40 times the APC payment rate. If a CMHC provider meets this condition, the outlier payment is calculated as 50 percent of the amount by which the cost exceeds 3.40 times the APC payment rate. In the CY 2007 OPPS proposed rule, we proposed to continue the same threshold policy for CY 2007 as we have established for CY 2006. An explanation for this proposed policy is discussed in section II.B.3. of the preamble to this final rule with comment period.

We received many comments on our proposed outlier policy for CY 2007.

Comment: Some commenters were concerned that the outlier threshold that CMS proposed is set too high and will result in CMS not spending all of the money in the projected 1.0 percent outlier target. The commenters stated that the estimated outlier target amount has historically been greater than the actual need, and they asked that CMS either reduce the set aside amount and retain that money in the OPPS rates or reduce the threshold for qualification so that the outlier expenditures are at a zero balance at the end of each year. One commenter asked that CMS limit the increase in the outlier threshold to the amount of the market basket update each year, which would mean, for CY 2007, that the CY 2006 threshold would be increased by only 3.4 percent.

Response: We believe that the threshold of $1,825 will result in paying 1.0 percent of the OPPS expenditures in outliers. As we indicated in the CY 2006 OPPS final rule, in the final set of CY 2004 OPPS claims, aggregated outlier payments were 2.5 percent of aggregated total OPPS payments. Similarly, using the final set of CY 2003 OPPS claims, aggregated outlier payments were 3.1 percent of total OPPS payments. As stated earlier, in the final set of CY 2005 claims, aggregated outlier payments were 2.39 percent of the aggregated total OPPS payments. For all three years, the estimated outlier payments were set at 2.0 percent of the total aggregated OPPS payments. Hence, our historic estimation of outlier payments has resulted in outlier payments that exceeded our target, and we believe that our proposed methodology will provide an outlier threshold that will result in more accurate aggregate program outlier payments.

As discussed above, for the proposed rule, we used a charge inflation factor of 1.1515 to inflate the charges for CY 2005 claims to CY 2007 dollars. We then applied the provider's overall CCR that we calculate as part of our APC median estimation process to those inflated charges to estimate costs. We compared these estimated costs to 1.75 times the proposed APC payment amount and to the APC payment amount plus a number of fixed-dollar thresholds until we identified a threshold that produced an estimate of total outlier payments equal to 1.0 percent of total aggregated OPPS payments.

We used the same estimation process for this final rule with comment period. We used a complete set of CY 2005 claims, and the updated charge inflation Start Printed Page 68012estimate of 1.1642 percent from the FY 2007 IPPS final rule and each hospital's overall CCR, as calculated for our APC median setting process.

Using this methodology, the final fixed-dollar threshold for the CY 2007 OPPS is $1,825, and the final multiple threshold is 1.75 times the APC payment rate.

We did not increase the CY 2007 outlier threshold by the market basket update of 3.4 percent because our calculations are intended to best approximate the outlier target of 1.0 percent of CY 2007 OPPS expenditures. As we stated in the CY 2006 OPPS final rule, we established the projected target for aggregate outlier payments at 1.0 percent because we believed, consistent with MedPAC's recommendations, that the fairly narrow definitions of APC groups make outlier payment less necessary for the OPPS, that multiple service payments are common for any given claim, and that the susceptibility to “gaming” through charge inflation continues (70 FR 68563). Because OPPS outlier payments are targeted to services, rather than clinical cases, we believe it is unlikely that any specific service would be excessively costly, and reducing the outlier threshold to 1.0 percent of total OPPS payment effectively raises the payment for all other services. We continue to believe that an outlier target of 1.0 percent of total OPPS payment is appropriate for the OPPS.

Comment: One commenter asked that CMS modify the charge methodology used to set the OPPS outlier threshold to account for the change in CCRs over time in a manner similar to that used for the FY 2007 IPPS. The commenter believed that it is appropriate to apply an adjustment factor to the CCRs, so that the CCRs CMS would use in simulations of outlier payments would more closely reflect the CCRs that would be used in CY 2007.

Response: Given the potential difference in cost increases between inpatient and outpatient hospital departments, we do not believe it would be appropriate to apply the exact same CCR adjustment used under the IPPS without an OPPS-specific analysis. However, it is possible that a similar analysis specific to the OPPS could indicate that it would be appropriate to apply an OPPS CCR adjustment. We expect to study this issue further and would address any changes to the outlier methodology through future rulemaking.

Comment: Some commenters objected to the lack of analysis to support the statement that the proposed outlier threshold would result in full payment of the outlier pool and urged CMS to publish the estimated outlier payments in the proposed rule, based on available data, to permit the public to better comment on the proposed outlier policy.

Response: The proposed rule contained considerable discussion of the methodology we use to create the proposed outlier threshold, as well as the projected program expenditure amount that we use to determine the amount of the outlier set aside. Moreover, the claims we used for the simulation are available to the public. Indeed, the commenters perform many different types of analyses and often comment in extreme detail based on their analyses of the claims data and our description of the methodology we use to calculate the median costs on which the payment rates are based. Therefore, the public has every opportunity to perform a full and complete analysis of our outlier projections in preparation for commenting on the proposed outlier policy.

Comment: One commenter objected to the payment of 50 percent of the cost that exceeds the threshold and believed that CMS should pay 80 percent of the cost rather than 50 percent to ameliorate the level of losses that major teaching hospitals incur to provide complex outpatient services and to make outlier payment under the OPPS consistent with IPPS outlier payment.

Response: We disagree with the commenter that we should pay 80 percent of the cost that exceeds the threshold to ameliorate the level of losses that major teaching hospitals incur and to make outlier payment under the OPPS consistent with outlier payment under the IPPS. As we have explained, if we increase the percent of the excess over cost, in particular by 30 percent more than our proposed level of 50 percent, the threshold would need to be greatly increased to avoid paying more than the 1.0 percent we have allowed for outlier payments. Moreover, we do not believe that it is appropriate to have the same policy governing outlier payment under both the IPPS and the OPPS because of the inherent differences in the clinical cases and payment methodologies that characterize the two systems. The circumstances giving rise to outlier payments under each system are not found in the other system, and therefore applying the same outlier policies would likely be contrary to the reasons behind each policy.

After carefully considering the public comments received, we are finalizing our proposed policy for CY 2007 outlier payments. Recalculation of the fixed outlier threshold using this methodology results in a fixed-dollar outlier threshold of $1,825 and a multiple threshold of 1.75, based on an outlier estimate of 1.0 percent of payments projected to be made under the CY 2007 OPPS and outlier payments to be made at 50 percent of the amount by which the cost of furnishing the service exceeds 1.75 times the APC rate. The following is an example of an outlier calculation for CY 2007 under our final policy with this modification. A hospital charges $26,000 for a procedure. The wage adjusted, and rural adjusted, if applicable, APC payment for the procedure is $3,000. The provider's overall CCR is 0.30. The estimated cost to the hospital is $7,800 (0.30 × $26,000). To determine whether this provider is eligible for outlier payments for this procedure, the provider must determine whether the cost for the service exceeds both the APC outlier cost threshold (1.75 × APC payment) and the fixed-dollar threshold ($1,825 + APC payment). In this example, the provider meets both criteria:

(1) $7,800 exceeds $5,250 (1.75 × $3,000).

(2) $7,800 exceeds $4,825 ($3,000 + $1,825).

To calculate the outlier payment, which is 50 percent of the amount by which the cost of furnishing the service exceeds 1.75 times the APC rate, subtract $5,250 (1.75 × $3,000) from $7,800 (resulting in $2,550). The provider is eligible for 50 percent of the difference, in this case $1,275 ($2,550/2). The formula is (cost − (1.75 × APC payment rate))/2.

H. Calculation of the OPPS National Unadjusted Medicare Payment

The basic methodology for determining prospective payment rates for OPD services under the OPPS is set forth in existing regulations at § 419.31 and § 419.32. The payment rate for services and procedures for which payment is made under the OPPS is the product of the conversion factor calculated in accordance with section II.C. of this final rule with comment period and the relative weight determined under section II.A. of this final rule with comment period. Therefore, the national unadjusted payment rate for each APC contained in Addendum A to this final rule with comment period and for HCPCS codes to which payment under the OPPS has been assigned in Addendum B to this final rule with comment period (Addendum B is provided as a convenience for readers) was calculated by multiplying the final CY 2007 scaled Start Printed Page 68013weight for the APC by the final CY 2007 conversion factor.

However, to determine the payment that will be made in a calendar year under the OPPS to a specific hospital for an APC for a service that has a status indicator of “S,” “T,” “V,” or “X” in a circumstance in which the multiple procedure discount does not apply, we take the following steps:

Step 1. Calculate 60 percent (the labor-related portion) of the national unadjusted payment rate. Since the initial implementation of the OPPS, we have used 60 percent to represent our estimate of that portion of costs attributable, on average, to labor. (Refer to the April 7, 2000 final rule with comment period (65 FR 18496 through 18497) for a detailed discussion of how we derived this percentage.)

Step 2. Determine the wage index area in which the hospital is located and identify the wage index level that applies to the specific hospital. The wage index values assigned to each area reflect the new geographic statistical areas as a result of revised OMB standards (urban and rural) to which hospitals are assigned for FY 2007 under the IPPS, reclassifications through the Medicare Classification Geographic Review Board, section 1866(d)(8)(B) “Lugar” hospitals, and section 401 of Pub. L. 108-173, and the reclassifications of hospitals under the one-time appeals process under section 508 of Pub. L. 108-173. The wage index values include the occupational mix adjustment described in section II.D. of this final rule with comment period that was developed for the final FY 2007 IPPS payment rates and finalized in the IPPS notice published in the Federal Register on October 11, 2006 (71 FR 59886). These finalized FY 2007 IPPS wage indices, which are effective October 1, 2007, have been adjusted 100 percent for differences in occupational mix. As is our practice, we adopt changes made to the FY 2007 IPPS wage index values after they have been finalized.

Step 3. Adjust the wage index of hospitals located in certain qualifying counties that have a relatively high percentage of hospital employees who reside in the county, but who work in a different county with a higher wage index, in accordance with section 505 of Pub. L. 108-173. Addendum L contains the qualifying counties and the finalized wage index increase developed for the FY 2007 IPPS (71 FR 59886). This step is to be followed only if the hospital has chosen not to accept reclassification under Step 2 above.

Step 4. Multiply the applicable wage index determined under Steps 2 and 3 by the amount determined under Step 1 that represents the labor-related portion of the national unadjusted payment rate.

Step 5. Calculate 40 percent (the nonlabor-related portion) of the national unadjusted payment rate and add that amount to the resulting product of Step 4. The result is the wage index adjusted payment rate for the relevant wage index area.

Step 6. If a provider is a SCH, as defined in § 412.92, and located in a rural area, as defined in § 412.63(b), or is treated as being located in a rural area under § 412.103 of the Act, multiply the wage index adjusted payment rate by 1.071 to calculate the total payment.

We did not receive any public comments on our proposed methodology for calculating the national unadjusted Medicare payment amount for CY 2007. Therefore, we are finalizing our proposed methodology for CY 2007 without modification.

I. Beneficiary Copayments for CY 2007

1. Background

Section 1833(t)(3)(B) of the Act requires the Secretary to set rules for determining copayment amounts to be paid by beneficiaries for covered OPD services. Section 1833(t)(8)(C)(ii) of the Act specifies that the Secretary must reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed specified percentages. For all services paid under the OPPS in CY 2007, and in calendar years thereafter, the specified percentage is 40 percent of the APC payment rate (section 1833(t)(8)(C)(ii)(V) of the Act). Section 1833(t)(3)(B)(ii) of the Act provides that, for a covered OPD service (or group of such services) furnished in a year, the national unadjusted coinsurance amount cannot be less than 20 percent of the OPD fee schedule amount.

Sections 1834(d) (2) and (d)(3) of the Act further require Medicare to pay the lesser of the ASC or OPPS payment rate for screening flexible sigmoidoscopies and screening colonoscopies, with coinsurance equal to 25 percent of the payment amount. We have applied the 25-percent coinsurance to all of these services since the beginning of the OPPS. Medicare does not make payment to ASCs for screening sigmoidoscopies so there is no payment comparison to be made for those services. However, for CY 2007, the OPPS payment for screening colonoscopies, HCPCS codes G0105 (Colorectal cancer screening; colonoscopy on individual at risk) and G0121 (Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk), developed in accordance with our standard OPPS ratesetting methodology, would exceed the ASC payment of $446 for these procedures. Therefore, for CY 2007, the OPPS payment rates for HCPCS codes G0105 and G0121 that describe screening colonoscopies will be set to equal the CY 2007 ASC rate of $446 for these services.

2. Copayment for CY 2007

For CY 2007, we proposed to determine copayment amounts for new and revised APCs using the same methodology that we implemented for CY 2004. (Refer to the November 7, 2003 OPPS final rule with comment period, 68 FR 63458.) These unadjusted copayment amounts for services payable under the OPPS that will be effective January 1, 2007, are shown in Addendum A and Addendum B of this final rule with comment period.

3. Calculation of an Adjusted Copayment Amount for an APC Group for CY 2007

To calculate the OPPS adjusted copayment amount for an APC group, take the following steps:

Step 1. Calculate the beneficiary payment percentage for the APC by dividing the APC's national unadjusted copayment by its payment rate. For example, using APC 0001, $7.00 is 23 percent of $30.21.

Step 2. Calculate the wage adjusted payment rate for the APC, for the provider in question, as indicated in section II.H. of this preamble. Calculate the rural adjustment for eligible providers as indicated in section I.H. of this preamble.

Step 3. Multiply the percentage calculated in Step 1 by the payment rate calculated in Step 2. The result is the wage-adjusted copayment amount for the APC.

The unadjusted copayments for services payable under the OPPS that will be effective January 1, 2007, are shown in Addendum A and Addendum B of this final rule with comment period.

We did not receive any public comments concerning our methodology for calculating the beneficiary unadjusted copayment amount. Therefore, we are finalizing our proposed methodology for CY 2007 without modification. Start Printed Page 68014

III. OPPS Ambulatory Payment Classification (APC) Group Policies

A. Treatment of New HCPCS and CPT Codes

1. Treatment of New HCPCS Codes Included in the Second and Third Quarterly OPPS Updates for CY 2006

During the second and third quarters of CY 2006, we created a total of four new Level II HCPCS codes, specifically C9227, C9228, C9229, and C9230 that were not addressed in the November 10, 2005 final rule with comment period that updated the CY 2006 OPPS. We designated the payment status of these codes and added them either through the April update (Transmittal 896, dated March 24, 2006) or the July update of the CY 2006 OPPS (Transmittal 970, dated May 30, 2006). In the CY 2007 OPPS proposed rule, we also solicited public comments on the status indicators and APC assignments of these codes, which were listed in Table 5 of that proposed rule (71 FR 49548), and now appear in Table 5 of this final rule with comment period. Because of the timing of the proposed rule, the codes implemented in the July 2006 OPPS update were not included in Addendum B of that proposed rule, while those codes based upon the April 2006 OPPS update were included in Addendum B. In the CY 2007 OPPS proposed rule, we proposed to assign the new HCPCS codes for CY 2007 to the appropriate APCs and incorporate them into our final rule with comment period for CY 2007, which is consistent with our annual APC updating policy.

We did not receive any public comments on the APC assignments and status indicators designated for C9227, C9228, C9229, or C9230 that were implemented in either April 2006 or July 2006. However, for CY 2007, the National HCPCS Panel created permanent J-codes for each of these drugs. Consistent with our general policy of using permanent HCPCS codes if appropriate rather than C-codes for the reporting of drugs under the OPPS in order to streamline coding, we are showing the J-codes in Table 5 that replaced the C-codes, effective January 1, 2007. C9227 is replaced with J2248 (Injection, micafungin sodium, 1 mg); C9228 with J3243 (Injection, tigecycline, 1 mg); C9229 with J1740 (Injection, ibandronate sodium, 1 mg); and C9230 with J0129 (Injection, abatacept, 10 mg). The J-codes describe the same drugs and the same dosages as the C-codes that will be deleted December 31, 2006. We note that C-codes are temporary national HCPCS codes. To avoid duplication, temporary national HCPCS codes, such as C, G, K, and Q codes, are generally deleted once permanent national HCPCS codes are created that describe the same item, service, or procedure. Because the four new J-codes describe the same drugs and the same dosages that are currently designated by C9227, C9228, C9229, and C9230 and all four of these drugs will continue with pass-through status in CY 2007, we are assigning the J-codes to the same APCs and status indicators as their predecessor C-codes, as shown in Table 5. That is, J2248 will be assigned to the same APC and status indicator as C9227; J3243 to APC 9228; J1740 to APC 9229; and J0129 to APC 9230. Because we received no public comments on the APC and status indicator assignments for the new HCPCS codes that were implemented in April or July 2006, we are adopting as final without modification, our proposal to assign their replacement HCPCS J-codes to the appropriate APCs, as shown in Addendum B of this final rule with comment period.

Table 5.—New HCPCS Codes Implemented in April or July 2006

New HCPCS J-Code effective January 1, 2007HCPCS C-CodeDescriptionAssigned status indicatorAssigned APC
J2248C9227Injection, micafungin sodium, per 1 mgG9227
J3243C9228Injection, tigecycline, per 1 mgG9228
J1740C9229Injection, ibandronate sodium, per 1 mgG9229
J0129C9230Injection, abatacept, per 10 mgG9230

2. Treatment of New CY 2007 Category I and III CPT Codes and Level II HCPCS Codes

As has been our practice in the past, we implement new Category I and III CPT codes and new Level II HCPCS codes, which are released in the summer through the fall of each year for annual updating, effective January 1, in the final rule updating the OPPS for the following calendar year. These codes are flagged with comment indicator “NI” in Addendum B of the OPPS final rule to indicate that we are assigning them an interim payment status which is subject to public comment following publication of the final rule that implements the annual OPPS update. (See the discussion immediately below concerning our modified policy for implementing new Category I and III mid-year CPT codes.) In our CY 2007 OPPS proposed rule, we proposed to continue this recognition and process for CY 2007. Therefore, new Category I and III CPT codes and new Level II HCPCS codes, effective January 1, 2007, are listed in Addendum B of this final rule with comment period and designated using comment indicator “NI.” The status indicator, the APC assignment, or both, for all such codes flagged with Comment Indicator “NI” are open to public comment. As indicated in the CY 2007 OPPS proposed rule, we will respond to all comments received concerning these codes in a subsequent final rule for the next calendar year's OPPS update.

We received some comments to the CY 2007 proposed rule regarding individual new HCPCS codes that commenters expected to be implemented for the first time in the CY 2007 OPPS. We could not discuss APC and/or status indictor assignments for new CY 2007 HCPCS codes in the proposed rule because the codes were not available when we developed and issued the proposed rule. For those new Category I CPT codes whose descriptors were not officially available during the comment period and development of the CY 2007 final rule with comment period, we do not specifically respond to those comments in this final rule with comment period. For those new Category III CPT codes that were released on July 1, 2006, for implementation January 1, 2007, we respond to those comments in this final rule with comment period because those codes were publicly available during the comment period to the proposed rule and the development of this final rule with comment period. Both of these groups of codes are flagged with comment indicator “NI” in this final rule with comment period, as discussed above, to signal that they are open to public comment. Start Printed Page 68015

Two new G-codes for CY 2007 that are assigned comment indicator “NI” in this final rule with comment period were developed to enable clinicians and facilities to specifically report transluminal balloon angioplasty to existing arteriovenous fistulas or prosthetic grafts for hemodialysis access. Currently, there are no CPT or alphanumeric HCPCS codes on the ASC list that would provide payment to ASCs for providing this service to Medicare patients with failing or stenotic hemodialysis access fistulas or grafts. There are no CPT codes that are specific to this particular service. Therefore, we are creating two Level II HCPCS G-codes for implementation in CY 2007: (1) G0392 (Transluminal balloon angioplasty, percutaneous, hemodialysis access fistula or graft; arterial) and (2) G0393 (Transluminal balloon angioplasty, percutaneous, hemodialysis access fistula or graft; venous). We will provide payment for these G-codes at the same OPPS rates as for CPT codes 35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic trunk or branches, each vessel) and 35476 (Transluminal balloon angioplasty, percutaneous; venous) through APC 0081 (Non-Coronary Angioplasty or Atherectomy), with a CY 2007 final median cost of $2,450.64. We will also assign both G-codes to payment group 9 for ASC payment in CY 2007. The G-codes will be used by hospital outpatient departments and ASCs to report transluminal balloon angioplasty of hemodialysis access fistulas or grafts in these settings.

Beginning in CY 2007, CPT codes 35475 and 35476 should not be reported for patients undergoing percutaneous transluminal balloon angioplasty of hemodialysis access fistulas or grafts. Both CPT codes will remain active to report all other clinical services that would be described by these codes.

We did not receive any public comments on our proposal to assign a comment indicator of “NI” in Addendum B of the OPPS final rule to the new codes that are open to public comment. Therefore, we are finalizing our proposed treatment of new CY 2007 Category I and III CPT codes, as well as the Level II HCPCS codes, without modification.

3. Treatment of New Mid-Year CPT Codes

Twice each year, the AMA issues Category III CPT codes, which the AMA defines as temporary codes for emerging technology, services, and procedures. (In addition, the AMA issues mid-year Category I CPT codes for vaccines for which FDA approval is imminent, to ensure timely availability of a code.) The AMA establishes these codes to allow collection of data specific to the service described by the code, as these services could otherwise only be reported using a Category I CPT unlisted code. The AMA releases Category III CPT codes in January, for implementation beginning the following July, and in July, for implementation beginning the following January. Prior to CY 2006, we treated new Category III CPT codes implemented in July of the previous year or January of the OPPS update year in the same manner that new Category I CPT codes and new Level II HCPCS codes implemented in January of the OPPS update year are treated; that is, we provided APC or status indicator assignments or both in the final rule updating the OPPS for the following calendar year. New Category I and Category III CPT codes, as well as new Level II HCPCS codes, were flagged with comment indicator “NI” in Addendum B of the final rule to indicate that we assigned them an interim payment status which was subject to public comment following publication of the final rule that implemented the annual OPPS update.

As discussed in the CY 2006 OPPS final rule with comment period (70 FR 68567), we modified our process for implementing the Category III codes that the AMA releases each January for implementation in July to ensure timely collection of data pertinent to the services described by the codes; to ensure patient access to the services the codes describe; and to eliminate potential redundancy between Category III CPT codes and some of the C-codes that are payable under the OPPS and were created by us in response to applications for new technology services. Therefore, beginning on July 1, 2006, we implemented in the OPPS seven Category III CPT codes that the AMA released in January 2006 for implementation in July 2006. These codes were shown in Table 6 of the CY 2007 OPPS proposed rule (71 FR 49549). They were not included in Addendum B of that rule, which was based upon the April 2006 OPPS update. In the CY 2007 OPPS proposed rule, we solicited public comments on the status indicators and, if applicable, the APC assignments of these services. We proposed in the CY 2007 OPPS proposed rule to finalize the assignments of these Category III CPT codes implemented in July 2006 in this final rule with comment period.

As indicated in the CY 2007 OPPS proposed rule (71 FR 49549), some of the new Category III CPT codes describe services that we have determined to be similar in clinical characteristics and resource use to HCPCS codes in an existing APC. In these instances, we may assign the Category III CPT code to the appropriate clinical APC. Other Category III CPT codes describe services that we have determined are not compatible with an existing clinical APC, yet are appropriately provided in the hospital outpatient setting. In these cases, we may assign the Category III CPT code to what we estimate is an appropriately priced New Technology APC. In other cases, we may assign a Category III CPT code to one of several nonseparately payable status indicators, including “N,” “C,” “B,” or “E,” which we believe is appropriate for the specific code. We expect that we will have received applications for new technology status for some of the services described by new Category III CPT codes, which may assist us in determining appropriate APC assignments. If the AMA establishes a Category III CPT code for a service for which an application has been submitted to CMS for new technology status, CMS may not have to issue a temporary Level II HCPCS code to describe the service, as has often been the case in the past when Category III CPT codes were only recognized by the OPPS on an annual basis.

Therefore, for CY 2007, we proposed to include in Addendum B of this final rule with comment period, the new Category III CPT codes and the new Category I CPT codes for vaccines released in January 2006 for implementation on July 1, 2006 (through the OPPS quarterly update process) and the Category III and vaccine Category I CPT codes released in July 2006 for implementation on January 1, 2007. However, only those new Category III CPT codes and the new vaccine codes implemented effective January 1, 2007, are flagged with comment indicator “NI” in Addendum B of this final rule with comment period to indicate that we have assigned them an interim payment status which is subject to public comment. As discussed earlier, Category III CPT codes implemented in July 2006, which appear in Table 6, were subject to comment through the CY 2007 OPPS proposed rule and their statuses are finalized in this final rule with comment period. Start Printed Page 68016

Table 6.—Category III CPT Codes Implemented in July 2006

CPT codeLong descriptorProposed CY 2007 status indicatorProposed CY 2007 APCFinal CY 2007 status indicatorFinal CY 2007 APC
0155TLaparoscopy, surgical, implantation or replacement of gastric stimulation electrodes, lesser curvature (ie, morbid obesity)T0130T0130
0156TLaparoscopy, surgical, revision or removal of gastric stimulation electrodes, lesser curvature (ie, morbid obesity)T0130T0130
0157TLaparotomy, implantation or replacement of gastric stimulation electrodes, lesser curvature (ie, morbid obesity)C
0158TLaparotomy, revision or removal of gastric stimulation electrodes, lesser curvature (ie, morbid obesity)C
0159TComputer-aided detection, including computer algorithm analysis of MRI image data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation, breast MRIN
0160TTherapeutic repetitive transcranial magnetic stimulation treatment planningX0340S0216
0161TTherapeutic repetitive transcranial magnetic stimulation treatment delivery and management, per sessionX0340S0216

We received several public comments on the proposed APC assignments for Category III CPT codes 0159T, 0160T, and 0161T. A summary of the comments and our responses follows:

Comment: One commenter requested that CMS assign CPT code 0159T to an APC that is separately payable under the OPPS because there are additional resources associated with performing a breast MRI with computer-aided detection (CAD), which is a significant advancement in early detection and treatment for possible breast cancers. The commenter indicated that the procedure described by CPT code 0159T is similar to the CAD procedures that are associated with mammography, which CMS previously recognized and allowed separate payment. The commenter urged CMS to pay separately for CPT code 0159T, if not through the hospital OPPS, then by a separate payment under the MFPS, similar to other hospital-based mammography services.

Response: The CAD procedures that the commenter makes reference to are described by CPT codes 77051 (Computer-aided detection (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation, with or without digitization of film radiographic images; diagnostic mammography) and 77052 (Computer-aided detection (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation, with or without digitization of film radiographic images; screening mammography). These are both paid off the MPFS, according to specific provisions in the law for screening and diagnostic mammography that specify that such services, when performed in the hospital outpatient setting, are paid according to the MPFS. Other hospital outpatient imaging services, such as CPT code 0159T, are paid under the OPPS. We have assigned this service packaged payment status under the OPPS for CY 2007, because we believe that it is a minor ancillary service that would always be provided in association with another separately payable service (mostly likely an MRI), into which its payment would be appropriately packaged. As a prospective payment system, the OPPS makes payment for groups of services that are clinically coherent with similar resource utilization and packages payment for many items, supplies, and minor associated services into the payment for the primary service. Our final CY 2007 treatment of CPT code 0159T is the same as our final CY 2007 packaged status for two chest x-ray CAD services, CPT code 0174T (Computer-aided detection (CAD) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed concurrent with primary interpretation) and CPT code 0175T (Computer aided detection (CAD) (computer algorithm analysis of digital image data for lesion detection) with further physician review for interpretation and report, with or without digitization of film radiographic images, chest radiograph(s), performed remote from primary interpretation) that is discussed further in section II.A.4. of this final rule with comment period.

Comment: One commenter requested that CMS not map Category III CPT codes 0160T and 0161T to APC 0340 (Minor Ancillary Procedures) because the technology associated with these procedures is currently under review by the FDA and approval is not expected until January 2007. The commenter indicated that these codes describe therapeutic transcranial magnetic stimulation (TMS) therapy, which is used for the treatment of major depression. The commenter further indicated that TMS therapy represents a procedure that involves a complex brain mapping and stimulation treatment process and requires the use of specific equipment and a specialized operator skill set. As such, the commenter concluded that TMS therapy represents a procedure whose hospital resources are significantly greater than reflected by the proposed payment rate for APC 0340 of about $38. The commenter believed that mapping Category III CPT codes 0160T and 0161T to APC 0340, or to any other APCs, is inappropriate at this time because the costs of these services are currently not known. The commenter cautioned that assigning these codes to specific APCs would be arbitrary and could significantly overcompensate or undercompensate providers because there are no cost data available to appropriately map codes 0160T and 0161T at this time. The commenter acknowledged that not assigning the two codes to specific APCs may result in no payment for TMS therapy performed in hospital outpatient settings for CY 2007 and likely limit access for some patients. However, the commenter indicated that it plans to work with the APC Panel in CY 2007 to determine the appropriate mapping for the two codes to ensure access for appropriate patients.

Other commenters noted that there was a related Category III code, CPT code 0018T (Delivery of high power, Start Printed Page 68017focal magnetic pulses for direct stimulation to cortical neurons) that was created prior to the full maturation of the therapeutic TMS procedure and related technology. The commenters noted differences between CPT code 0018T and the two new Category III CPT codes, including its lack of incorporation of the treatment planning function, its failure to specify repetitive in the descriptor, and its lack of description of therapeutic treatment delivery. They believed that the historical APC assignment of code 0018T to APC 0215 (Level I Nerve and Muscle Tests) was inappropriate, although one commenter stated that it was not involved in determining that mapping. The commenters pointed out that there are also two Category I CPT codes that incorporate TMS for diagnostic purposes, including CPT code 95928 (Central motor evoked potential study (transcranial motor stimulation); upper limbs) and CPT code 95929 (Central motor evoked potential study (transcranial motor simulation); lower limbs). The commenters added that both of these codes were proposed for assignment to APC 0218 (Level II Nerve and Muscle Tests) for CY 2007 with a payment rate of about $74.

Response: We appreciate the commenters' suggestion and background information. However, because the CPT code descriptors are general in nature and not specific to a particular product, our policy has been to assign an APC to each Category III CPT code if we believe that the procedure, if covered, would be appropriate for separate payment in the OPPS.

In addition, as indicated in the CY 2006 OPPS final rule (70 FR 68567), some of the new Category III CPT codes may describe services that our medical advisors determine to be similar in clinical characteristics and resource use to HCPCS codes in an existing APC. In such instances, we may assign the Category III CPT code to the appropriate clinical APC. Other Category III CPT codes may describe services that our medical advisors determine are not compatible with an existing clinical APC, yet are appropriately provided in the hospital outpatient setting. In these cases, we may assign the Category III CPT code to what we estimate is an appropriately priced New Technology APC. In the case of CPT codes 0160T and 0161T, we believe the services described by these active CPT codes would be appropriately separately paid under the OPPS if they are covered. We do not believe the technology used to provide these services is so new that their assignment to New Technology APCs would be appropriate. Although our final determination regarding these two codes is to provide assignments to specific APCs with payment rates for CY 2007 as described below, this decision does not represent a determination that the services described by Category III CPT codes 0160T and 0161T are reasonable and necessary. Medicare contractors determine whether the services described by all HCPCS codes with status indicators reflecting their potential for payment under the OPPS, including Category III CPT codes, meet all the program requirements for coverage in different clinical circumstances.

The Internet listing of Category III code changes on the AMA Web site includes a parenthetical note that CPT Code 0018T has been deleted as of July 1, 2006, the same date new CPT codes 0160T and 0161T were first implemented. The note also indicates that, to report the procedure previously described by 0018T, one should see CPT codes 0160T and 0161T. CPT Changes, an Insider's View for CY 2002 when 0018T was created, describes the use of CPT code 0018T for treatment of a patient with a long history of depression, incorporating planning and therapeutic treatment delivery in the description of the procedure. In general, that outline of the service described by CPT code 0018T closely parallels the clinical vignettes for CPT codes 0160T and 0161T that were provided to us in a public comment. Therefore, we do not agree with the commenters that our historical claims for 0018T must be instances of miscoding or the use of TMS for diagnostic purposes. While we had no claims for CPT code 0018T for CY 2005, we do have claims data for this service from CYs 2002 through 2004, although there were fewer than 15 total claims for each of those years. The procedure was assigned to APC 0215 (Level I Nerve and Muscle Tests) with a payment rate of about $35 throughout that time period, with no specific comments from the public on this assignment during the OPPS proposed updates for those years.

We understand that the hospital resource costs of specific technologies may change over time as those technologies evolve. In reviewing the clinical aspects of CPT codes 0160T and 0161T, in the context of related codes and our historical OPPS claims data for CPT code 0018T and other services, we agree with the commenter that APC 0340 is not the most appropriate assignment for CPT codes 0160T and 0161T for CY 2007. The commenter provided no specific suggestions regarding the APC assignments for these codes. As discussed earlier, CPT codes describe general services that are not specific to one product, and we believe it is most appropriate to provide APC assignments for all new HCPCS codes that would be appropriately separately paid under the OPPS if they were covered. This approach helps ensure access to services described by these codes for Medicare beneficiaries in the hospital outpatient department and allows us to initiate collection of hospital cost information as soon as possible. The commenter indicated that TMS may be safely performed in the hospital outpatient setting. We do not see any reason to provide the Category III CPT codes for TMS nonpayable status indicators in the OPPS for CY 2007, when the codes were implemented in July 2006 and there are no alternative HCPCS codes to describe the services. However, we believe that APC 0216 (Level III Nerve and Muscle Tests) best represents both the clinical and resource homogeneity of CPT codes 0160T and 0161T for CY 2007, considering all of the information available to us. We note that this APC has a status indicator of “S,” so that under the occasional circumstance of two treatments in one day for a single patient as described by a commenter, payment would not be reduced for the second service. We will reevaluate these assignments for future OPPS updates as additional information becomes available to us, including updated claims data.

After carefully considering the comments received, we are finalizing our general proposal for the treatment of new mid-year CPT codes, with modification only to the CY 2007 APC assignments for Category III CPT codes 0160T and 0161T as described above and indicated in Table 6.

B. Variations Within APCs

1. Background

Section 1833(t)(2)(A) of the Act requires the Secretary to develop a classification system for covered hospital outpatient services. Section 1833(t)(2)(B) of the Act provides that this classification system may be composed of groups of services, so that services within each group are comparable clinically and with respect to the use of resources. In accordance with these provisions, we developed a grouping classification system, referred to as the Ambulatory Payment Classification Groups (or APCs), as set forth in § 419.31 of the regulations. We use Level I and Level II HCPCS codes and descriptors to identify and group the services within each APC. The APCs Start Printed Page 68018are organized such that each group is homogeneous both clinically and in terms of resource use. Using this classification system, we have established distinct groups of surgical, diagnostic, and partial hospitalization services, as well as medical visits. We also have developed separate APC groups for certain medical devices, drugs, biologicals, radiopharmaceuticals, and brachytherapy devices.

We have packaged into each procedure or service within an APC group the costs associated with those items or services that are directly related and integral to performing a procedure or furnishing a service. Therefore, we do not make separate payment for packaged items or services. For example, packaged items and services include: (1) Use of an operating, treatment, or procedure room; (2) use of a recovery room; (3) most observation services; (4) anesthesia; (5) medical/surgical supplies; (6) pharmaceuticals (other than those for which separate payment may be allowed under the provisions discussed in section V of this preamble); and (7) incidental services such as venipuncture. Our proposed packaging methodology is discussed in section II.A. of this preamble.

Under the OPPS, we pay for hospital outpatient services on a rate-per-service basis that varies according to the APC group to which the service is assigned. Each APC weight represents the hospital median cost of the services included in that APC relative to the hospital median cost of the services included in APC 0606. The APC weights are scaled to APC 0606 because we are proposing it to be the middle level clinic visit APC (that is, where the Level III Clinic Visit HCPCS code of five levels of clinic visits is assigned), and because middle level clinic visits are among the most frequently furnished services in the outpatient hospital setting. See section II.A.3. of this preamble for a complete discussion of the reasons for choosing APC 0606 as the basis for scaling the APC relative weights.

Section 1833(t)(9)(A) of the Act requires the Secretary to review the components of the OPPS not less than annually and to revise the groups and relative payment weights and make other adjustments to take into account changes in medical practice, changes in technology, and the addition of new services, new cost data, and other relevant information and factors. Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of the BBRA of 1999, also requires the Secretary, beginning in CY 2001, to consult with an outside panel of experts to review the APC groups and the relative payment weights (the APC Panel recommendations for specific services for CY 2007 OPPS and our responses to them are discussed in the relevant specific sections throughout this preamble).

Finally, as discussed earlier, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median (or mean cost, if elected by the Secretary) for an item or service in the group is more than 2 times greater than the lowest median cost for an item or service within the same group (referred to as the “2 times rule”). We use the median cost of the item or service in implementing this provision. The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as low-volume items and services.

2. Application of the 2 Times Rule

In accordance with section 1833(t)(2) of the Act and § 419.31 of the regulations, we annually review the items and services within an APC group to determine, with respect to comparability of the use of resources, if the median of the highest cost item or service within an APC group is more than 2 times greater than the median of the lowest cost item or service within that same group (“2 times rule”). We make exceptions to this limit on the variation of costs within each APC group in unusual cases such as low-volume items and services.

During the APC Panel's March 2006 meeting, we presented median cost and utilization data for services furnished during the period of January 1, 2005, through September 30, 2005, about which we had concerns or about which the public had raised concerns regarding their APC assignments, status indicator assignments, or payment rates. The discussions of most service-specific issues, the APC Panel recommendations, if any, and our proposals for CY 2007 are contained principally in sections III.C. and III.D. of this preamble.

In addition to the assignment of specific services to APCs which we discussed with the APC Panel, we also identified APCs with 2 times violations that were not specifically discussed with the APC Panel but for which we proposed changes to their HCPCS codes' APC assignments in Addendum B of the CY 2007 proposed rule. In these cases, to eliminate a 2 times violation, we reassigned the codes to APCs that contained services that were similar with regard to both resource use and clinical homogeneity. We also proposed changes to the status indicators for some codes that were not specifically and separately discussed in the proposed rule. In these cases, we changed the status indicators for some codes because we believed that another status indicator more accurately described their payment status from an OPPS perspective based on our CY 2007 proposed policies.

Addendum B of the CY 2007 OPPS proposed rule identified with a comment indicator “CH” those HCPCS codes for which we proposed a change to the APC assignment or status indicator as assigned in the April 2006 Addendum B update. Addendum B of this final rule with comment period identifies with the “CH” comment indicator the final CY 2007 changes compared to the codes” status as reflected in the October 2006 Addendum B update.

We received many public comments regarding the proposed APC and status indicator assignments for CY 2007 for specific HCPCS codes. These are discussed mainly in sections III.C. and III.D. of this final rule with comment period, and the final action for CY 2007 related to each HCPCS code is noted in those sections.

3. Exceptions to the 2 Times Rule

As discussed earlier, we may make exceptions to the 2 times limit on the variation of costs within each APC group in unusual cases such as low-volume items and services. At the time of the proposed rule, taking into account the APC changes that we proposed for CY 2007 based on the APC Panel recommendations discussed mainly in sections III.C. and III.D. of the preamble, the proposed changes to status indicators and APC assignments as identified in Addendum B of the CY 2007 OPPS proposed rule, and the use of CY 2005 claims data to calculate the median costs of procedures classified in the APCs, we reviewed all the APCs to determine which APCs would not satisfy the 2 times rule. We used the following criteria to decide whether to propose exceptions to the 2 times rule for affected APCs:

  • Resource homogeneity
  • Clinical homogeneity
  • Hospital concentration
  • Frequency of service (volume)
  • Opportunity for upcoding and code fragments.

For a detailed discussion of these criteria, refer to the April 7, 2000 OPPS final rule with comment period (65 FR 18457).

Table 7 published in the CY 2007 OPPS proposed rule (71 FR 49551) Start Printed Page 68019listed the APCs that we proposed to exempt from the 2 times rule based on the criteria cited above. For cases in which a recommendation by the APC Panel appeared to result in or allow a violation of the 2 times rule, we generally accepted the APC Panel's recommendation because those recommendations were based on explicit consideration of resource use, clinical homogeneity, hospital specialization, and the quality of the data used to determine the APC payment rates that we proposed for CY 2007. The median costs for hospital outpatient services for these and all other APCs which were used in development of the proposed rule can be found on the CMS Web site: http://www.cms.hhs.gov.

We did not receive any general public comments related to the list of proposed exceptions to the 2 times rule. We received a number of specific comments about some of the procedures assigned to APCs that we proposed to make exempt from the 2 times rule for CY 2007. Those discussions are elsewhere in the preamble, in sections related to the types of procedures that were the subjects of the comments.

For the proposed rule, the listed exceptions to the 2 times rule were based on data from January 1, 2005, through September 30, 2005. For this final rule with comment period, we used data from January 1, 2005 through December 1, 2005. Thus, after responding to all of the comments on the proposed rule and making changes to APC assignments based on those comments, we analyzed the full CY 2005 data to identify APCs with 2 times rule violations.

Based on those final data, we found that there were 37 APCs with 2 times rule violations. We applied the criteria as described earlier to finalize the APCs that are exceptions to the 2 times rule for CY 2007. The final revised list of APCs that are exceptions to the 2 times rule for CY 2007 is displayed in Table 7 below. After careful review of all public comments on the proposed rule and the claims data for the full year, CY 2005, available to us for this final rule with comment period, we are finalizing the list of APCs exempted from the two times rule as displayed in Table 7 below.

Table 7.—APC Exceptions to the 2 Times Rule for CY 2007

APCAPC description
0007Level II Incision & Drainage.
0010Level I Destruction of Lesion.
0019Level I Excision/ Biopsy.
0024Level I Skin Repair.
0040Percutaneous Implantation of Neurostimulator Electrodes, Excluding Cranial Nerve.
0043Closed Treatment Fracture Finger/Toe/Trunk.
0058Level I Strapping and Cast Application.
0060Manipulation Therapy.
0081Non-Coronary Angioplasty or Atherectomy.
0093Vascular Reconstruction/Fistula Repair without Device.
0105Revision/Removal of Pacemakers, AICD, or Vascular.
0111Blood Product Exchange.
0112Apheresis, Photopheresis, and Plasmapheresis.
0203Level IV Nerve Injections.
0204Level I Nerve Injections.
0215Level I Nerve and Muscle Tests.
0245Level I Cataract Procedures without IOL Insert.
0251Level I ENT Procedures.
0252Level II ENT Procedures.
0274Myelography.
0303Treatment Device Construction.
0307Myocardial Positron Emission Tomography (PET) Imaging.
0312Radioelement Applications.
0323Extended Individual Psychotherapy.
0330Dental Procedures.
0340Minor Ancillary Procedures.
0367Level I Pulmonary Test.
0381Single Allergy Tests.
0397Vascular Imaging.
0409Red Blood Cell Tests.
0418Insertion of Left Ventricular Pacing Elect.
0432Health and Behavior Services.
0437Level II Drug Administration.
0604Level I Clinic Visits.
0621Level I Vascular Access Procedures.
0664Level I Proton Beam Radiation Therapy.
0676Thrombolysis and Thrombectomy.

C. New Technology APCs

1. Introduction

In the November 30, 2001 final rule (66 FR 59903), we finalized changes to the time period a service was eligible for payment under a New Technology APC. Beginning in CY 2002, we retain services within New Technology APC groups until we gather sufficient claims data to enable us to assign the service to a clinically appropriate APC. This policy allows us to move a service from a New Technology APC in less than 2 years if sufficient data are available. It also allows us to retain a service in a New Technology APC for more than 3 years if sufficient data upon which to base a decision for reassignment have not been collected. More recently, at its August 2006 meeting the APC Panel recommended that when CMS assigns a new service to a New Technology APC, the service should remain there for at Start Printed Page 68020least 2 years until sufficient claims data are collected. In general, services remain in New Technology APCs for at least 2 years consistent with the APC Panel's recommendation. However, we do not fully accept the APC Panel's recommendation. While we agree with the APC Panel that we need sufficient claims data to move services from New Technology APCs to clinical APCs, we also continue to believe that it occasionally may be appropriate to move a service from a New Technology APC to a clinical APC in less than 2 years if the data are robust and there is an appropriate clinical APC for its assignment.

We note that the cost bands for New Technology APCs range from $0 to $50 in increments of $10, from $50 to $100 in increments of $50, from $100 through $2,000 in intervals of $100, and from $2,000 through $6,000 in intervals of $500. These intervals, which are in two parallel sets of New Technology APCs, one with status indicator “S” and the other with status indicator “T,” allow us to price new technology services more appropriately and consistently.

Every year we receive many requests for higher payment amounts for specific procedures under the OPPS because they require the use of expensive equipment. We are taking this opportunity to reiterate our response in general to the issue of hospitals' capital expenditures as they relate to the OPPS and Medicare.

Under the OPPS, one of our goals is to make payments that are appropriate for the services that are necessary for the treatment of Medicare beneficiaries. The OPPS, like other Medicare payment systems, is budget neutral and so, although we do not pay full hospital costs for procedures, we believe that our payment rates generally reflect the costs that are associated with providing care to Medicare beneficiaries in cost-efficient settings. Further, we believe that our rates are adequate to assure access to services for most beneficiaries.

For many emerging technologies there is a transitional period during which utilization may be low, often because providers are first learning about the techniques and their clinical utility. Quite often, the requests for higher payment amounts are for new procedures in that transitional phase. These requests, and their accompanying estimates for expected Medicare beneficiary or total patient utilization, often reflect very low rates of patient use, resulting in high per use costs for which requesters believe Medicare should make full payment. Medicare does not, and we believe should not, assume responsibility for more than its share of the costs of procedures based on Medicare beneficiary projected utilization and does not set its payment rates based on initial projections of low utilization for services that require expensive capital equipment. For the OPPS, we rely on hospitals to make informed business decisions regarding the acquisition of high cost capital equipment, taking into consideration their knowledge about their entire patient base (Medicare beneficiaries included) and an understanding of Medicare's and other payers' payment policies.

We note that in a budget neutral environment, payments may not fully cover hospitals' costs, including those for the purchase and maintenance of capital equipment. We rely on providers to make their decisions regarding the acquisition of high cost equipment with the understanding that the Medicare program must be careful to establish its initial payment rates for new services that lack hospital claims data based on realistic utilization projections for all such services delivered in cost-efficient hospital outpatient settings. As the OPPS acquires claims data regarding hospital costs associated with new procedures, we will regularly examine the claims data and any available new information regarding the clinical aspects of new procedures to confirm that our OPPS payments remain appropriate for procedures as they transition into mainstream medical practice.

2. Movement of Procedures From New Technology APCs to Clinical APCs

As we explained in the November 30, 2001 final rule (66 FR 59897), we generally keep a procedure in the New Technology APC to which it is initially assigned until we have collected data sufficient to enable us to move the procedure to a clinically appropriate APC. However, in cases where we find that our original New Technology APC assignment was based on inaccurate or inadequate information, or where the New Technology APCs are restructured, we may, based on more recent resource utilization information (including claims data) or the availability of refined New Technology APC bands, reassign the procedure or service to a different New Technology APC that most appropriately reflects its cost.

The procedures presented below represent services assigned to New Technology APCs for CY 2006 for which at the time of developing the proposed rule we believed we had sufficient data to reassign them to clinically appropriate APCs for CY 2007.

a. Nonmyocardial Positron Emission Tomography (PET) Scans (APC 0308)

Positron emission tomography (PET) is a noninvasive diagnostic imaging procedure that assesses the level of metabolic activity and perfusion in various organ systems of the human body. PET serves an important role in the clinical care of many Medicare beneficiaries. We recognize that PET is a useful technology in many instances and want to ensure that the technology remains available to Medicare beneficiaries when medically necessary. Since August 2000, nonmyocardial PET procedures have been assigned to a New Technology APC in the OPPS. As a result of our collection of 5 full years of hospital claims data, in the CY 2007 proposed rule (71 FR 49566 through 49567) we indicated that we believed that we had sufficient data to assign nonmyocardial PET scans to a clinically appropriate APC for CY 2007. We assign a service to a New Technology APC only when we do not have adequate claims data upon which to determine the median cost of performing the procedure, and we expect that the service's clinical or resource characteristics will differ from all other procedures already assigned to clinical APCs. Each New Technology APC represents a particular cost band (for example, $1,400-1,500), and we assign procedures to these APCs based on our analysis of the costs of the procedures. Payment for items assigned to a New Technology APC is the midpoint of the band (for example, $1,450). We move a service from a New Technology APC to a clinical APC when we have adequate claims data upon which to base its future payment rate. As noted in the CY 2007 proposed rule, in the case of nonmyocardial PET services, we believed that we had sufficient data to assign them to a clinically appropriate APC.

For CY 2006, we maintained the APC payment methodologies from CY 2005 for nonmyocardial PET services. According to that methodology, payment was based on a 50/50 blend of their median cost based on CY 2003 claims data and the payment rate of the CY 2004 New Technology APC to which they were assigned. Therefore, nonmyocardial PET scans were assigned to New Technology APC 1513 (New Technology—Level XIII ($1100-$1200)) for a blended payment rate of $1,150.

For CY 2007, we proposed the assignment of nonmyocardial PET procedures to a clinically appropriate APC as we now have several years of robust and stable claims data upon which to determine the median cost of Start Printed Page 68021performing these procedures. Based on analysis of the Medicare claims data, the median costs for nonmyocardial PET scans have ranged between approximately $852 and $924 for claims submitted from CY 2002 through CY 2005. However, our payment rates have been significantly higher than the median costs throughout this same time period. We have observed significant growth in the number of nonmyocardial PET scans performed on Medicare beneficiaries, from about 48,000 in CY 2002, to 68,000 in CY 2003, and to 121,000 in CY 2004, the year when we first reduced the OPPS nonmyocardial PET scan payment rates from $1,450 to $1,150. For the CY 2007 OPPS proposed rule, we had about 45,000 single PET claims from CY 2005, yielding a stable median cost for PET procedures of about $867. Although the CY 2005 claims data were not complete when we published the CY 2007 OPPS proposed rule, we noted that the apparent decline in numbers of claims for nonmyocardial PET scans alone in the CY 2005 claims data was likely related to the large number of claims for PET/CT scans observed in CY 2005, when codes for that combined service were first available for billing. In fact, the total number of PET scans provided to Medicare beneficiaries in CY 2005, defined as PET scans and PET/CT scans, continued to climb to almost 128,000 based upon the CY 2005 claims data available for the proposed rule, in comparison to final claims for CY 2004 of approximately 121,000 for PET scans.

Therefore, we proposed to assign nonmyocardial PET scans, in particular, CPT codes 78608, 78811, 78812, and 78813, to new APC 0308 (Nonmyocardial Positron Emission Tomography (PET) Imaging) with a median cost of $865.30 for CY 2007. We noted we were confident that in the face of our stable median costs for nonmyocardial PET scans over the past 4 years, their additional 2-year period of receiving New Technology APC payments at the blended rate of $1,150 for CY 2005 and CY 2006 as we transitioned the services to a clinical APC would ensure continued availability of this technology now that its services would be paid through a clinical APC in CY 2007, like most other OPPS services.

Comment: A few commenters representing rural providers stated that they would no longer be able to provide PET scans to their patients who are Medicare beneficiaries if Medicare lowered its payment for the services. They stated that, because they relied on more costly, mobile units, the proposed payment amount would not be adequate for them to be able to continue to provide the service in their communities. A number of other commenters opposed proposed payment reductions for PET imaging services that they believed were essential to ensuring appropriate treatment of patients with cancer and providing necessary patient access.

Response: We are sensitive to the obstacles that rural providers face in trying to provide some services to Medicare beneficiaries. However, we have years of stable and consistent data that indicate that Medicare will now be paying more accurately for the scans at the proposed clinical APC rate. We believe this rate will ensure the necessary patient access to PET services.

Comment: Several commenters requested that, instead of assigning CPT code 78608 (Brain imaging, positron emission tomography (PET); metabolic evaluation), to APC 0308 with the CPT codes for tumor PET scans, CMS should assign this single code to a separate clinical APC. The commenters had no objections to assignment of PET services to clinical APCs, with payment rates based on the APCs' median costs. The commenters believed that assignment of the CPT code for brain PET scans to its own APC would be more appropriate because the brain PET scans are not clinically homogenous with the other tumor PET scans assigned to APC 0308.

Response: The brain PET scan services have been assigned to the same New Technology APC with the same payment rate as the other nonmyocardial PET services for a number of years. The CY 2005 median cost for the brain PET CPT code of $886 is very similar to the median costs for the two tumor PET CPT codes of $873 and $762, indicating that all three of these related PET services require comparable hospital resources. We are not convinced that separating nonmyocardial PET scans according to the body site being examined is necessary for clinical homogeneity, and the result of such a distinction would be a single CPT code in one APC and two CPT codes in another APC. The OPPS is a prospective payment system that provides payment for groups of services that share clinical and resource use characteristics. We believe that PET scans for tumor imaging and brain imaging are similar in both respects and are appropriately assigned to the same clinical APC. Therefore, we are finalizing our proposal to assign CPT code 78608 to APC 0308, along with CPT codes 78811, 78812, and 78813.

After carefully considering the comments, we are adopting our proposal for CY 2007 without modification to provide payment for nonmyocardial PET scans through APC 0308.

b. PET/Computed Tomography (CT) Scans (APC 0308)

Since August 2000, we have paid separately for PET and CT scans. In CY 2004, the payment rate for nonmyocardial PET scans was $1,450, while it was $193 for typical diagnostic CT scans. Prior to CY 2005, nonmyocardial PET and the PET portion of PET/CT scans were described by G-codes for billing to Medicare. Several commenters on the November 15, 2004 final rule with comment period (69 FR 65682) urged us to replace the G-codes for nonmyocardial PET and PET/CT scan procedures with the established CPT codes. These commenters stated that movement to the established CPT codes would greatly reduce the burden on hospitals of tracking and billing the G-codes that were not recognized by other payers and would allow for more uniform hospital billing of these scans. We agreed with the commenters that movement from the G-codes to the established CPT codes for nonmyocardial PET and PET/CT scans would allow for more uniform billing of these scans. As a result of a Medicare national coverage determination (Publication 100-3, Medicare Claims Processing Manual section 220.6) that was made effective January 28, 2005, we discontinued numerous G-codes that described myocardial PET and nonmyocardial PET procedures and replaced them with the established CPT codes. The CY 2005 payment rate for concurrent PET/CT scans using CPT codes 78814, 78815, and 78816 was $1,250, which was $100 higher than the payment rate for PET scans alone. These PET/CT CPT codes were placed in New Technology APC 1514 (New Technology—Level XIV ($1,200-$1,300)) for CY 2005. We continued with these coding and payment methodologies in CY 2006.

For CY 2007, we proposed the assignment of concurrent PET/CT scans, specifically CPT codes 78814, 78815, and 78816, to a clinically appropriate APC because we believed that we had adequate claims data from CY 2005 upon which to determine the median cost of performing these procedures. At the time of the proposed rule, based on our analysis of CY 2005 single claims, the median cost of PET/CT scans was $865 from almost 70,000 single claims. Comparison of the median cost of nonmyocardial PET procedures of $867 with the median cost of concurrent PET/CT scans demonstrated that the median costs of PET scans with or without Start Printed Page 68022concurrent CT scans for attenuation correction and anatomical localization were about the same. This result was not unexpected because many newer PET scanners also had the capability of rapidly acquiring CT images for attenuation correction and anatomical localization, sometimes with simultaneous image acquisition.

To explore the possibility that the similarity in median costs for PET and PET/CT procedures could be related to different groups of hospitals billing the two types of PET services based on their available equipment, rather than the true comparability of hospital resources required for the two types of services, we analyzed claims from a subset of hospitals billing both PET and PET/CT scans in CY 2005. This analysis looked at 362 providers that billed a PET HCPCS code and a PET/CT CPT code at least one time each during CY 2005. The median cost from this subset of claims for nonmyocardial PET scans was $890, in comparison with $863 for the PET/CT scans. Thus, we observed the same close relationship between median costs of PET and PET/CT procedures from hospitals billing both sets of services as we did for all OPPS CY 2005 claims available for the proposed rule for these scans. We believed that our claims data accurately reflected the comparable hospital resources required to provide PET and PET/CT procedures, and the scans had obvious clinical similarity as well. Therefore, for CY 2007 we proposed to assign the CPT codes for PET/CT scans, along with the CPT codes for PET scans, to the same new APC 0308 (Nonmyocardial Positron Emission Tomography (PET) Imaging) with a proposed median cost of $865.30.

At its August 2006 meeting, the APC Panel recommended that CMS retain PET/CT scans in New Technology APC 1514 with a payment rate of $1,250 for CY 2007.

We note that we have been paying separately for fluorodeoxyglucose (FDG), the radiopharmaceutical described by HCPCS code A9552 (Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries) that is commonly administered during nonmyocardial PET and PET/CT procedures. For CY 2007, we proposed to continue paying separately for FDG, according to the methodology described in section V. of the preamble of the CY 2007 proposed rule.

Comment: A number of commenters disagreed with the proposal to assign PET/CT services to APC 0308. Among the reasons provided by commenters that PET/CT services should not be assigned to APC 0308 were that: payment at the proposed level would not cover the costs of providing the services; the APC Panel recommended during its August 2006 meeting that CMS retain PET/CT services in New Technology APC 1514 for another year so that more CPT-coded claims upon which to base a decision about the appropriate APC assignment for the services would be available; PET/CT services are a clinically distinct technology from conventional PET procedures and should not be assigned to the same APC; PET/CT services are more costly to provide than are other nonmyocardial PET services and there must be a payment differential to recognize that; and a 30-percent payment decrease would result in decreased Medicare beneficiary access to the services. The commenters reported that the higher costs associated with PET/CT were due to requirements for specially-trained, licensed technicians, more costly capital equipment, and higher equipment maintenance costs.

Most commenters recommended that PET/CT should remain in its current New Technology APC 1514 with a payment rate of $1,250 for CY 2007. Some of the commenters believed that CMS' proposal to assign PET/CT scans to a clinical APC was premature because CMS did not have a full year of reliable cost data for PET/CT. They made that assertion because the CPT codes used to report the services were newly recognized by the OPPS in April 2005 and, therefore, only 9 months of claims data were available for the CY 2007 OPPS update. The commenters observed that if PET/CT scans were moved to a clinical APC for CY 2007, they would have been assigned to a New Technology APC for only 21 months, while the APC Panel recommended at its August 2006 meeting that services assigned to New Technology APCs should remain there for at least 2 years. Further, because hospitals often do not update their chargemasters more than once per year, the commenters believed that true hospital costs were not reflected in the CY 2005 data that CMS considered when developing its proposal for CY 2007.

One of the commenters provided limited hospital-level average cost data for PET and PET/CT scans, as well as a cost analysis model for PET/CT services. Those data covered the 6-month period of July through December and display average cost and charge data for two sets of hospitals, separated according to two different methods of reducing their charges to costs.

Response: We have carefully considered the APC Panel recommendation and all of the information provided in the comments received regarding the proposed APC assignment and payment amount for PET/CT scans for CY 2007. We remain confident that our CY 2005 data for conventional nonmyocardial PET services are accurate reflections of hospital costs for those services, in spite of the CY 2005 coding changes. Similarly, our review of the hospital data provided in one of the public comments shows that the average cost per hospital for PET/CT for one set of hospitals was $829 and for the other group was $912. We are encouraged that these mean costs are so similar to our median cost for the services, and these data serve to increase our confidence in the CY 2005 claims data.

However, we recognize that there are other factors to consider related to hospital charging practices for PET/CT services. For instance, prior to institution of the specific CPT codes for PET/CT scans, hospitals were reporting a diagnostic CT scan charge in addition to the appropriate G-code charge for the PET scan. Therefore, the transition to the new CPT codes was not a simple coding crosswalk for the PET/CT services because it required the hospital to change from reporting two charges for the service to only one charge that was to include the costs of the entire service. We are aware that making that adjustment may have been difficult for some hospitals.

After considering the information and opinions provided to us in the comments, particularly with respect to our data that are limited to 9 months of claims (although there are over 76,000 single claims from that time period), we are persuaded that there are valid reasons to assign PET/CT services to a different APC than the conventional PET services for CY 2007. We are convinced that, in this instance, we should wait for a full year of CPT-coded claims data prior to assigning the PET/CT services to a clinical APC and that maintaining a modest payment differential between PET and PET/CT procedures is warranted for CY 2007.

For these reasons, we are assigning PET/CT to a different APC than conventional PET services for CY 2007, based on our continued expectation of the appropriate relative cost difference between the two types of services. When we first recognized PET/CT CPT codes for payment in CY 2005, we established their payment rate at $100 more than the payment rate for PET scans. Although the commenters to the CY 2007 proposed rule did not provide specific information regarding an appropriate differential between Start Printed Page 68023payments for PET and PET/CT scans, the commenters generally did not oppose our proposed payment for PET scans through a clinical APC with a payment rate of about $850. Historically, when both PET and PET/CT scans were assigned to New Technology APCs with a $100 payment difference for CYs 2005 and 2006, we received few public comments indicating that payment difference was inappropriate. Therefore, we are assigning PET/CT scans to New Technology APC 1511 (New Technology—Level XI ($900-$1,000)) with a payment of $950 for CY 2007 to maintain the approximately $100 difference between payments these services and nonmyocardial PET scans, which will be assigned to APC 0308 with a median cost of about $850 for CY 2007. In this way, the differential payment between conventional PET and PET/CT scans will be preserved at an appropriate level, the payment decrease for PET/CT procedures will be moderated as the services transition to payment based on their costs in a clinical APC, and CMS will be able to consider a full 12 months of CPT-coded claims prior to making the assignment of PET/CT scans to a clinical APC.

c. Stereotactic Radiosurgery (SRS) Treatment Delivery Services (APCs 0065, 0066, and 0067)

For the past several years, we have collected hospital costs associated with the planning and delivery of stereotactic radiosurgery services (hereafter referred to as SRS). As new technology emerged in the field of SRS, public commenters urged us to recognize cost differences associated with the various methods of SRS planning and delivery. Beginning in CY 2001, we established G-codes to capture any such cost variations associated with the various methods of planning and delivery of SRS. For CY 2004, based on comments received regarding the G-codes used for SRS, we made some modifications to the coding (68 FR 63431 and 63432). First, we received comments regarding the descriptors for HCPCS codes G0173 and G0251, indicating that these codes did not distinguish image-guided robotic SRS systems from other forms of linear accelerator-based SRS systems to account for the cost variation in delivering these services. In response, for CY 2004 we created two new G-codes (G0339 and G0340) to describe complete and fractionated image-guided robotic linear accelerator-based SRS treatment. We placed HCPCS code G0339 in APC 1528 at a payment rate of $5,250, and HCPCS code G0340 in APC 1525 at a payment rate of $3,750. Second, we received comments on HCPCS code G0242 which requested that we modify the code descriptor to avoid confusion and misuse of the code, and also to appropriately describe treatment planning for both linear accelerator-based and Cobalt 60-based SRS treatments. In response, for CY 2004, we created HCPCS code G0338 to distinguish linear accelerator-based SRS treatment planning from Cobalt 60-based SRS treatment planning. We placed HCPCS code G0338 in APC 1516 at a payment rate of $1,450.

In CY 2005, there were no changes to the coding or New Technology APC payment rates for the SRS planning or treatment delivery codes from CY 2004. We stated in the CY 2005 OPPS final rule with comment period (69 FR 65711) that any SRS code changes would be premature without cost data to support a code restructuring. Therefore, we maintained HCPCS codes G0173, G0242, G0243, G0251, G0338, G0339, and G0340 in their respective New Technology APCs for CY 2005. We further stated that until we had completed an analysis of claims for these procedure codes, we would continue to maintain HCPCS codes G0173, G0242, G0243, G0251, G0338, G0339, and G0340 in their respective New Technology APCs for CY 2005 as we considered the adoption of CPT codes to describe all SRS procedures for CY 2006.

At its February 2005 meeting, the APC Panel discussed the clinical and resource cost similarities between planning for Cobalt 60-based and linear accelerator-based SRS. The APC Panel also discussed the use of CPT codes instead of specific G-codes to describe the services involved in SRS planning, noting the clinical similarities in radiation treatment planning regardless of the mode of treatment delivery. Given the APC Panel's deliberations about the possible need for CMS to separately track planning for SRS, the APC Panel eventually recommended that CMS create a single HCPCS code to encompass both Cobalt 60-based and linear accelerator-based SRS planning. Because we had no programmatic need to separately track SRS planning services, in the CY 2006 OPPS final rule with comment period (70 FR 68585), we discontinued HCPCS codes G0242 and G0338 for the reporting of charges for SRS planning and instructed hospitals to bill charges for SRS planning, regardless of the mode of treatment delivery, using all of the available CPT codes that most accurately reflect the services provided.

Furthermore, the APC Panel recommended that CMS make no changes to the coding or APC placement of SRS treatment delivery HCPCS codes G0173, G0243, G0251, G0339, and G0340 for CY 2006. In addition, presenters to the APC Panel described ongoing deliberations among interested professional societies around the descriptions and coding for SRS. The APC Panel and presenters suggested that CMS wait for the outcome of these deliberations before making any significant changes to SRS delivery coding or payment rates. As indicated in the CY 2007 OPPS proposed rule, we did not receive a report from participating professional societies as to the outcome of such deliberations prior to publishing that rule (71 FR 49554).

In response to comments for CY 2006 regarding the mature technology and stable median costs associated with Cobalt 60-based SRS treatment delivery described by HCPCS code G0243, we reassigned G0243 from a New Technology APC to new clinical APC 0127 (Stereotactic Radiosurgery), with a payment rate of $7,305 established based on the CY 2004 median cost of G0243. We made no changes for CY 2006 to the New Technology APC assignments of the other four SRS treatment codes, specifically, G0173, G0251, G0339, and G0340.

Since we first established the full group of SRS treatment delivery codes in CY 2004, we now have 2 years of hospital claims data reflecting the costs of each of these services. Based on our proposed rule analysis of our claims data from CY 2004 and CY 2005, the median costs for linear accelerator-based SRS treatment delivery procedures as described by HCPCS codes G0173, G0251, G0339, and G0340 have been stable and generally lower than our New Technology APC payment rates in effect from CY 2004 through CY 2006. Specifically, the payment rate for HCPCS code G0173, a complete course of non-image guided, non-robotic linear accelerator-based SRS treatment, has been set at $5,250, yet our claims data indicate a median cost of $2,802 from CY 2004 claims and $3,665 from our proposed rule CY 2005 claims, based upon hundreds of single claims from each year. For HCPCS code G0251, fractionated non-image guided, non-robotic linear accelerator-based SRS treatment, the corresponding median costs have been $1,028 and $1,386 based upon over 1,000 single claims from each year, and relatively consistent with the procedure's New Technology APC payment of $1,150. With respect to the complete course of therapy in one session or first fraction of image-guided, robotic linear accelerator-based SRS, described by HCPCS code G0339, its Start Printed Page 68024median costs have been $4,917 and $4,809 for CY 2004 and CY 2005 respectively, based upon over 500 single bills in each year, in comparison with the procedure's payment rate of $5,250 for those years. Lastly, the median costs of HCPCS code G0340, the second through fifth sessions of image-guided, robotic linear accelerator-based SRS treatment, have been $2,502 for CY 2004 and $2,917 for CY 2005 as determined by over 1,000 single bills during each year, significantly lower than its payment rate of $3,750. Unquestionably, the claims data from CY 2004 and CY 2005 for linear accelerator-based SRS treatment delivery services revealed highly stable median costs from year to year based on significant claims volume.

Based on the above findings, in the CY 2007 proposed rule we indicated that we believed that we had adequate claims data to assign the SRS treatment delivery procedures to clinically appropriate APCs, and we believed that such movement was appropriate. For CY 2007, we proposed to create several new SRS clinical APCs of different levels to assign the HCPCS codes describing linear accelerator-based SRS treatment, G0173, G0251, G0339, and G0340, based on their clinical and hospital resource similarities and differences. In particular, we proposed to assign HCPCS codes G0339 and G0173 to the same Level III SRS APC, because we believed that these codes that describe the complete or first fraction of all types of linear accelerator-based SRS treatments had substantial hospital resource and clinical similarity, as observed in their median costs and recognized previously in their equivalent New Technology APC payments. The codes describing subsequent fractions of image-guided, robotic and non-image guided, non-robotic linear accelerator-based SRS treatments were each assigned to their own clinical APCs in our proposal, as they demonstrated significant differences in resource utilization as reflected in their median costs. Their previous assignments to different New Technology APCs anticipated these resource distinctions. We proposed to continue our assignment of HCPCS code G0243 for Cobalt 60-based SRS treatment delivery to clinical APC 0127, renamed Level IV Stereotactic Radiosurgery. Our proposed reassignments of SRS services from New Technology APCs to clinical APCs were listed in Table 8 of the CY 2007 OPPS proposed rule (71 FR 49554), which has been reproduced as Table 8 below, amended with the final status indicators, APC assignments, and median costs for these services.

We received many comments on our proposal from hospitals, health professionals, and various healthcare associations. A summary of the comments and our responses follow:

Comment: Several commenters objected to our use of the CY 2005 claims data in setting the CY 2007 payment rates, specifically with regards to the image-guided robotic SRS services, as described by HCPCS codes G0339 and G0340. They indicated that the claims data used to set the proposed payment rates for HCPCS codes G0339 and G0340 were based on a flawed methodology because several centers providing these services submitted claims to CMS for less than a full year during CY 2004 and CY 2005. Because centers that provided image-guided SRS grew in number significantly over the past 2 years, the commenters believed that CMS did not have meaningful data over 2 years from a large number of institutions providing the services upon which to base the proposed changes. They believed that new technology services should have a minimum of 2 years of claims data before moving them to clinical APCs. These commenters urged CMS to maintain HCPCS code G0339 in its current New Technology APC 1528 with a payment rate of $5,250, and to also maintain HCPCS G0340 in its current New Technology APC 1525 with a payment rate of $3,750.

Response: In the November 30, 2001 final rule (66 FR 59903), we finalized changes to the time period a service was eligible for payment under a New Technology APC. Beginning in CY 2002, we noted that we would retain services within New Technology APC groups until we gathered sufficient claims data to enable us to assign the service to a clinically appropriate APC. There is no requirement for a minimum number of claims or years of claims data before services may be moved from New Technology APCs to clinical APCs.

In the case of the image-guided robotic SRS services, specifically G0339 and G0340, we continue to believe that we have adequate claims data from CY 2005 upon which to base our payments for CY 2007. Both HCPCS codes G0339 and G0340 were effective for reporting beginning January 1, 2004, under the OPPS, and consequently, we have 2 full years worth of hospital claims data for these services. As we noted earlier, the median costs for both procedures have been reasonably stable over the past 2 years based upon substantial numbers of single claims, and there was similar growth in both services from CY 2004 to CY 2005. The fact that image-guided robotic SRS centers have grown in number and service volume over the most recent 2 years of claims submissions is expected for new technology and other OPPS services. Many OPPS services are only provided in a small subset of hospitals paid under the OPPS, and we routinely establish APC median costs based on Medicare OPPS claims from the hospitals that were providing the services 2 years prior to the OPPS update year. We recognize that our claims data evolve over time, in part because the pool of hospitals providing certain procedures may change significantly.

The information provided in the comments did not convince us that the proposed payment rates for HCPCS code G0339 and G0340 were based on inadequate claims data that did not represent the costs of the procedures for the hospitals providing the services in CY 2005. Based on our final CY 2005 claims data, we found 1,535 single (of 1,655 total) claims for HCPCS code G0339 and 2,716 single (of 2,798 total) claims for HCPCS code G0340. We believe that the single claims data for both procedures are sufficiently robust for ratesetting purposes.

Comment: Several commenters agreed with CMS that the hospital claims data from the past 2 years for the SRS services have been relatively stable and based on at least several hundreds of claims both years. However, these commenters expressed concern about our proposal to assign HCPCS codes G0173 and G0339 to the same APC, specifically APC 0067 (Level III Stereotactic Radiosurgery). The commenters opposed assignment of the two procedures to the same APC because they believed that our claims data clearly showed that the median cost of G0339 has been significantly higher than the median cost of G0173 for both CY 2004 and CY 2005.

Response: Both services have been assigned to the same New Technology APC 1528 for the past 3 years because of our initial expectation that the costs of the first or complete session of linear accelerator-based SRS would be similar, regardless of whether or not the SRS procedure was an image-guided robotic service. While we have observed that their costs are somewhat different, we believe that they are sufficiently comparable to warrant placement of the SRS services in the same clinical APC, given the comparable clinical characteristics of the services. The OPPS provides payments based on APC groups of services that share clinical and resource characteristics, and the median of the highest cost service Start Printed Page 68025within an APC group should not be more than 2 times greater than the median cost of the lowest cost service within that same group. The final CY 2005 median cost of G0173 is $3,407.53, and the final CY 2005 median cost of G0339 is $4,126.46. These median costs are quite comparable, and APC 0067, configured as proposed, does not violate the 2 times limit on the variation of costs within the APC.

Therefore, for CY 2007, both HCPCS codes G0339 and G0173 are reassigned to clinical APC 0067 with a median cost of $3,872.87, and HCPCS code G0340 is reassigned to clinical APC 0066, with a median cost of $2,629.53.

Comment: Several organizations supported our proposed clinical APC assignments but were concerned by the extent of the payment reductions for certain services. The commenters expressed concern regarding the 23-percent reduction in payment for HCPCS codes G0173 and G0339. They urged CMS to review the cost calculations for all SRS services and use the most current claims data available for the CY 2007 OPPS final rule.

Response: We thank the commenters for their suggestion. The payment rates reflected in Table 8 are based on the latest and most complete CY 2005 claims data, with CY 2007 payment rates based upon APC median costs calculated according to the standard OPPS methodology. Almost all of the claims are single claims; therefore, we are confident that the observed costs in the claims data are representative of the costs of the SRS services provided in CY 2005.

Comment: Several commenters requested that CMS modify the descriptors for HCPCS codes G0339 and G0340 to be more precise and reflect the technology accurately. The commenters provided their proposed language, and indicated that not refining the descriptors would make it virtually impossible to determine appropriate APC payment rates for image-guided robotic SRS services in the future. They also urged CMS to work with the centers providing these specialized services to establish accurate and appropriate payments for image-guided robotic SRS.

Response: The recommended language provided by the commenters is very specific and may cause more confusion for hospitals and coders. Long descriptors of HCPCS codes that describe services and procedures are usually more general and not specific to a particular specialty or product. We do not establish HCPCS codes that are specific to certain technologies. Instead, we rely on hospitals to select the most specific HCPCS codes that accurately describe the services they provide. We believe that the current HCPCS code descriptors adequately distinguish image-guided robotic linear accelerator-based SRS from other types of SRS. We observe significant difference in the costs of G0251 and G0340 that describe the later fractions of non-image-guided and image-guided SRS respectively, so that they require assignment to two separate clinical APCs. We have no evidence that hospitals are not accurately reporting these services based on the technology utilized to provide SRS in their institutions.

For CY 2007, the CPT Editorial Panel created four new SRS Category I CPT codes in the Radiation Therapy section of the 2007 CPT manual. Specifically, the CPT Editorial Panel created CPT codes 77371 (Radiation treatment delivery, stereotactic radiosurgery (SRS) (complete course of treatment of cerebral lesion[s] consisting of 1 session); multi-source Cobalt 60 based)), 77372 (Radiation treatment delivery, stereotactic radiosurgery (SRS) (complete course of treatment of cerebral lesion[s] consisting of 1 session); linear accelerator based)), 77373 (Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions), and 77435 (Stereotactic body radiation therapy, treatment management, per treatment course, to one or more lesions, including image guidance, entire course not to exceed 5 fractions). For CY 2007, we will continue our recent practice of not recognizing established CPT code 61793 (Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator), one or more sessions) under the OPPS because the OPPS will utilize more specific SRS codes to provide appropriate payment for the facility resources associated with specific types of SRS treatment delivery. Below is our discussion of the new SRS CPT codes, and our assignments for the codes under the OPPS.

  • CPT code 77371 describes a cobalt-based SRS procedure for a single, complete treatment session of one or more cerebral lesions. Under the OPPS, this procedure has been separately payable under HCPCS code G0243 (Multi-source photon stereotactic radiosurgery, delivery including collimator changes and custom plugging, complete course of treatment, all lesions) since January 1, 2002. We believe this single CPT code may be appropriately reported in all clinical situations of cobalt-based SRS treatment. For CY 2007, HCPCS G0243 will no longer be reportable under the hospital OPPS because the code will be deleted and replaced with CPT code 77371, effective January 1, 2007. CPT code 77371 is assigned to the same APC and status indicator as its predecessor code (G0243). That is, for CY 2007, CPT code 77371 is assigned to APC 0127 (Level IV Stereotactic Radiosurgery) with a status indicator of “S”.
  • CPT code 77372 describes a single session, complete course of treatment, linear accelerator-based procedure. During CY 2006, this procedure was reported under one of two HCPCS codes, depending on the technology used, specifically, G0173 (Linear accelerator based stereotactic radiosurgery, complete course of therapy in one session) and G0339 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment). Because HCPCS codes G0173 and G0339 are more specific in their descriptors than CPT code 77372, we have decided to continue using G0173 and G0339 under the OPPS for CY 2007. Therefore, for CY 2007, we have assigned CPT code 77372 to status indicator “B” under the OPPS.
  • CPT code 77373 describes a fractionated session linear accelerator-based procedure. During CY 2006, CPT code 77373 was reported under one of three HCPCS codes depending on the circumstances and technology used, specifically, G0251 (Linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, maximum five sessions per course of treatment), G0339 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment), and G0340 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment). Because HCPCS codes G0251, G0339, and G0340 are more specific in their descriptors than CPT code 77373 and these HCPCS codes are assigned to different clinical APCs for CY 2007, we have decided to continue using G0251, G0339, and G0340 under the OPPS for CY 2007. Therefore, for CY 2007, we have assigned CPT code 77373 to status indicator “B” the hospital OPPS.
  • CPT code 77435 also describes treatment management for a full treatment course of linear accelerator-based SRS. During CY 2006, CPT code Start Printed Page 6802677435 was described under CPT code 0083T (Stereotactic body radiation therapy, treatment management, per day), which was assigned to status indicator “N” in the OPPS. The CPT Editorial Panel has decided to delete CPT code 0083T on December 31, 2006, and replaced it with CPT code 77435. Because the costs of SRS treatment management are already packaged into the OPPS payment rates for SRS treatment delivery, for CY2007 we have assigned CPT code 77435 to status indicator “N”, which is the same status indicator that was assigned to its predecessor Category III CPT code.

After carefully considering all the comments and concerns raised by the commenters, we are finalizing our proposal as shown in Table 8 without modification. Given the ample cost information reflected in the CY 2005 claims data for the SRS services and given the fact that these services have been in New Technology APCs for 3 full years, since they were first assigned to New Technology APCs beginning January 1, 2004, we believe our claims data are sufficient for us to move these services to clinical APCs. Therefore, for CY 2007, HCPCS codes G0173 and G0339 are assigned to clinical APC 0067, with a median cost of $3,872.87, HCPCS code G0251 to clinical APC 0065, with a median cost of $1,241.89, and HCPCS code G0340 to clinical APC 0066 with a median cost of $2,629.53. As described above, despite new CPT codes for SRS treatment delivery in CY 2007, coding for linear accelerator-based SRS treatment delivery services will not change in the CY 2007 OPPS.

Table 8.—Final APC Assignments for SRS Treatment Delivery Services for CY 2007

HCPCS codeShort descriptorCY 2006 SICY 2006 APCCY 2006 payment rateFinal CY 2007 SIFinal CY 2007 APCFinal CY 2007 APC median cost
G0173Linear acc stereo radsur comS1528$5,250.00S0067$3,872.87
G0251Linear acc based stero radioS15131,150.00S00651,241.89
G0339Robot lin-radsurg com, firstS15285,250.00S00673,872.87
G0340Robt lin-radsurg fractx 2-5S15253,750.00S00662,629.53

d. Magnetoencephalography (MEG) Services (APCs 0038 and 0209)

Magnetoencephalography (MEG) is a noninvasive diagnostic tool that assists surgeons in the presurgical period by measuring and mapping brain activity. It may be used for epilepsy and brain tumor patients. Since CY 2002, the MEG procedures described by CPT codes 95965 (Magnetoencephalography (MEG), recording and analysis; for spontaneous brain magnetic activity (eg, epileptic cerebral cortex localization)), 95966 (Magnetoencephalography (MEG), recording and analysis; for evoked magnetic fields, single modality (e.g., sensory, motor, language, or visual cortex localization)), and 95967 (Magnetoencephalography (MEG), recording and analysis; for evoked magnetic fields, each additional modality (e.g., sensory, motor, language, or visual cortex localization)) have been assigned to New Technology APCs. In the CY 2006 proposed rule (70 FR 42709), we proposed to reassign MEG procedures to clinical APC 0430 using CY 2004 claims data to establish median costs on which the CY 2006 payment rates would be based. This proposal involved the reassignment of the three MEG procedures, specifically CPT codes 95965, 95966, and 95967, from three separate New Technology APCs into one new clinical APC with a status indicator of “T.” The commenters on the CY 2006 proposal believed that their assignment to clinical APC 0430 would be inappropriate because the proposed payment level of $674 was inadequate to cover the costs of the procedures, and because the procedures should not be assigned to only one level as their required hospital resources differ significantly. They further stated that our data did not represent the true costs of the procedures because MEG procedures are performed on very few Medicare patients.

Analysis of our hospital data for claims submitted from CY 2002 through CY 2005 indicated that these procedures are rarely performed on Medicare beneficiaries. For claims submitted from CY 2002 through CY 2005, our single claims data showed that there were annually only between 2 and 23 claims submitted for CPT code 95965, between 3 and 7 claims for CPT code 95966, and only 1 claim for CPT code 95967. In addition, the hospital claims median costs for these codes have varied widely, perhaps due to our small volume of claims. The median cost for CPT code 95965 has ranged from $332 using CY 2002 claims to $3,166 based upon CY 2005 claims. The median cost for CPT code 95966 has varied widely from CY 2002 to CY 2005. For single claims submitted during CY 2002, the median cost was $1,949, while it was $507 for CY 2003, $1,435 for CY 2004, and $701 from 3 single claims for CY 2005. The median cost for CPT code 95967 based upon 1 single claim from CY 2005 claims was $217. As noted in our CY 2007 OPPS proposed rule (71 FR 49555), we had no hospital median cost data for CPT code 95967 prior to CY 2005.

In the November 10, 2005 final rule with comment period (70 FR 68579), we stated that we carefully considered our claims data, information provided by the commenters, and the APC Panel recommendation for CY 2006 that we retain the MEG procedures in New Technology APCs. As a result of this analysis, we determined that using a 50/50 blend of the code-specific median costs from our most recent CY 2004 hospital claims data and the CY 2005 New Technology APC code-specific payment amounts as the basis for assignment of the procedures for CY 2006 would be an appropriate way to recognize both the current payment rates for the procedures, which were originally based on the theoretical costs to hospitals of providing MEG services, and the median costs based upon our hospital claims data regarding actual MEG services provided to Medicare beneficiaries by hospitals. Therefore, CPT codes 95965, 95966, and 95967 were assigned to different New Technology APCs for CY 2006 based on this blended methodology, with payment rates of $2,750, $1,250, and $850 respectively.

At the March 2006 APC Panel meeting, the Panel recommended that CMS move CPT codes 95965 (MEG, spontaneous), 95966 (MEG, evoked, single), and 95967 (MEG, evoked, each additional) from their CY 2006 New Technology APCs which were assigned based on the blended methodology described above to clinical APC(s) for CY 2007. Following that meeting, interested parties provided us with CY 2005 charge and cost information from six hospitals that provided MEG services. These external data showed wide variation in hospitals' costs and charges for MEG procedures, with Start Printed Page 68027generally higher values for CPT code 95965 and lower values for CPT codes 95966 and 95967 but no consistent proportionate relationship among those costs and charges. In some cases, the charges and costs for CPT codes 95966 and 95967 were quite similar for the two related services, one of which describes MEG for a single modality of evoked magnetic fields and the other that describes MEG for each additional modality of evoked magnetic fields. The individual hospital cost and charge data for specific services demonstrated significant variations of up to six fold across the hospitals, with an apparent inverse relationship between the numbers of services provided and the costs of the procedures. This finding was not unexpected, given the dependence of MEG procedures on the use of expensive capital equipment. As we have previously stated, our OPPS payment rates generally reflect the costs that are associated with providing care to Medicare beneficiaries in cost-efficient settings. For emerging technologies, we establish payment rates for new services that lack hospital claims data based on realistic utilization projections for all such services delivered in cost-efficient hospital outpatient settings. In the CY 2007 OPPS proposed rule, we indicated that since we now had 4 years of hospital claims data for MEG procedures and because MEG was no longer a new technology, we did not believe these external data from six hospitals that performed MEG services in CY 2005 provided a better estimate of the hospital resources used in MEG procedures during the care of Medicare beneficiaries than our standard OPPS historical claims methodology.

We agreed with the APC Panel and proposed to accept their recommendation to move the MEG CPT codes into clinical APCs for CY 2007. While the volumes for the MEG procedures are low, almost all procedures, including those with very low Medicare volume, are assigned to clinical APCs under the OPPS, with their payment rates based on the median costs of their assigned APCs. Therefore, we proposed to assign CPT code 95965 to new clinical APC 0038 (Spontaneous MEG), with a proposed median cost of $3,166.30, and to assign both CPT codes 95966 and 95967 to APC 0209 (Level II MEG, Extended EEG Studies, and Sleep Studies), with a proposed median cost of $709.36. We believed that the assignment of CPT codes 95966 and 95967 to APC 0209 was appropriate because MEG studies were similar to EEGs and sleep studies in measuring activity of the brain over a significant time period, and our hospital claims data showed that their hospital resources were also relatively comparable. MEG procedures and their CY 2007 proposed APC assignments were displayed in Table 9 published in the CY 2007 OPPS proposed rule (71 FR 49556), which has been reproduced in Table 9 of this final rule with comment period and updated to include the final status indicators, APC assignments, and APC median costs for CY 2007.

Comment: Most of the commenters agreed with the APC assignments for both CPT codes 95965 and 95967 but requested that CMS reconsider the APC assignment for CPT code 95966. The commenters supported the establishment of a separate APC for CPT code 95965 and its proposed payment rate. They also agreed that CPT code 95967 is an add-on code that is always used in conjunction with CPT codes 95965 or 95966 and is less costly to perform. They generally agreed with the proposed APC assignment and payment rate for CPT code 95967, despite the very low volume of OPPS claims for the procedure. The commenters disagreed with the proposed APC and payment rate for CPT code 95966. They indicated that MEG is a highly specialized service performed in a limited number of hospitals in the U.S. Because the service is not commonly performed, the commenters acknowledged that Medicare beneficiaries represent only a small number of patients who receive MEG services because epilepsy surgery is rarely performed on elderly patients, which further explains the very low volume of these services in the Medicare claims data. While the commenters agreed with the proposed APC assignments for CPT codes 95965 and 95967, they believed that the resources required to perform 95966 were significantly higher than the payment rate reflected in APC 0209, its proposed assignment for CY 2007. The commenters indicated that the costs of MEG services were substantially higher than the EEG or sleep study services that are also assigned to APC 0209. As such, the commenters believed that CPT code 95966 should be assigned to its own APC at a rate equal to 50 percent of the payment rate for CPT code 95965, or approximately $1,550. They believed that this payment rate was supported by the hospital cost data for the six hospitals providing a high volume of MEG services, which were provided to CMS and discussed in the CY 2007 OPPS proposed rule.

Response: We appreciate the commenters' input and suggestions. However, given that we have 4 years of hospital claims data for MEG procedures and because MEG is no longer a new technology, we believe that the proposed APC assignment for CPT code 95966 is appropriate. If we were to assign CPT code 95966 to its own clinical APC, the median cost of that APC would be the median cost of CPT code 95966 of $709 from CY 2005 claims data, quite consistent with the median cost of APC 0209. We do not assign payment rates for clinical APCs based upon speculative relationships of the costs of its services to payments for other services. Instead, the standard OPPS methodology to develop the median cost of a clinical APC upon which a specific procedure's payment is based is to establish the APC median from claims data for all of the services assigned to the APC. As we have indicated above, while the volumes of MEG procedures are low, almost all procedures, including those with very low Medicare volume, are assigned to clinical APCs under the OPPS, with their payment rates based on the median costs of their assigned APCs. Taking into consideration our hospital claims data for CPT code 95966 from the last several years, we continue to believe that its assignment to APC 0209 is appropriate, and that the service is sufficiently similar to other diagnostic procedures also residing in the APC. Therefore, for CY 2007, we are assigning CPT code 95965 to APC 0038, with a final CY 2007 median cost of $3,270, and CPT codes 95966 and 95967 to APC 0209, with a final CY 2007 median cost of $687.

Comment: One commenter indicated that the claims data cited in the CY 2007 OPPS proposed rule for CPT codes 95965, 95966, and 95967 were based both on incomplete and inaccurate claims data. The commenter submitted copies of paid Medicare claims from CY 2005 for CPT code 95965, which included nine claims that reflected 5 months of data, each representing total charges greater than the CY 2007 proposed payment rate for CPT code 95965. The commenter requested that CMS consider these claims in determining the appropriate APC assignments for the MEG services.

Response: We confirmed that the claims data submitted to us are accurately reflected in the CY 2005 claims data used for the CY 2007 OPPS update. Consequently, we believe that our claims data adequately reflect the costs associated with providing the MEG service identified by CPT code 95965. In determining a hospital's cost for a service, we take the individual hospital's departmental CCR and multiply this by the total charge on a Start Printed Page 68028single claim for that service. In the event there is no applicable departmental CCR, we use the overall hospital-specific CCR. For this CY 2007 OPPS update, the average overall hospital CCR is 0.30142. Multiplying this average CCR by the typical MEG procedure charge of about $10,500 on the claims provided to us yields a cost for CPT code 95965 of about $3,165, consistent with the final CY 2007 median cost of APC 0038 of about $3,270. This median cost provides the basis for establishing the procedure's payment rate. Overall, we believe the claims provided by the commenter help to validate our final CY 2007 APC 0038 assignment of CPT code 95965, with its payment rate calculated according to our standard OPPS methodology.

After carefully reviewing the data and considering the public comments received, we are finalizing our proposal for APC assignment for MEG as shown in Table 9 without modification.

Table 9.—CY 2007 APC Assignment for MEG

HCPCS codeShort descriptorCY 2006 SICY 2006 APCCY 2006 payment rateCY 2007 SIFinal CY 2007 APCFinal CY 2007 APC median cost
95965Meg, spontaneousS1523$2,750.00S0038$3,270.35
95966Meg, evoked, singleS15141,250.00S0209687.26
95967Meg, evoked, each additionalS1510850.00S0209687.26

e. Other Services in New Technology APCs

Other than the PET, PET/CT, SRS, and MEG new technology services discussed in section III.C.2.a. through d. of this preamble, there are 23 procedures currently assigned to New Technology APCs for CY 2007 for which we believed we also had data that were adequate to support their assignment to clinical APCs. For CY 2007, we proposed to reassign these procedures to clinically appropriate APCs, applying their CY 2005 claims data to develop their clinical APC median costs upon which payments would be based. These procedures and their proposed APC assignments were displayed in Table 10 of the CY 2007 OPPS proposed rule. This table has been reproduced as Table 10 at the end of this section and updated with the final status indicators, APC assignments, and median costs.

We received many comments concerning the proposed reassignment of other new technology procedures listed in Table 10 to clinical APCs for CY 2007. A summary of the comments and our responses follow:

(1) Breast Brachytherapy (APCs 0029 and 0030)

For CY 2007, we proposed to reassign CPT code 19296 (Placement of radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy) from New Technology APC 1524 (New Technology Level XIV—($3000-$3500)) to clinical APC 0030 (Level III Breast Surgery) with a proposed median cost of $2,516.94. We also proposed to reassign CPT code 19297 (Placement of radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; concurrent with partial mastectomy) from New Technology APC 1523 (New Technology Level XXIII—($2500-$3000)) to clinical APC 0029 (Level II Breast Surgery), with a proposed median cost of $1,738.75.

Comment: Numerous commenters requested that CMS maintain CPT code 19296 and CPT code 19297 in New Technology APCs 1524 and 1523, respectively, for another year so that more claims data could be collected for both services. They were concerned about the proposed significant payment decreases for CPT codes 19296 and 19297 that ranged from -23 percent to -37 percent. The commenters also indicated that the number of hospital outpatient claims for both codes were low and thus inadequate to support their assignment to appropriate clinical APCs. The commenters indicated that in developing the proposed rule, CPT code 19296 had a total of 491 single claims for CY 2005, and only 36 single claims were available for CPT code 19297. One commenter was surprised that CMS would consider moving CPT code 19297 to a clinical APC with only 36 single claims, while CPT code 19298 (Place breast rad tube/caths), with 49 single claims for CY 2005, would continue to be assigned to New Technology APC 1524.

The commenters generally urged CMS to reevaluate the proposed clinical APCs for these procedures, and, if necessary, place them in more appropriate APCs that accurately reflected the costs and clinical characteristics of these services. Many commenters requested that CMS either continue to assign CPT codes 19296 and 19297 to their current CY 2006 New Technology APCs for CY 2007, or place them in APC 0648, retitled “Level IV Breast Surgery,” which had a proposed median cost of $3,012.92 and a CY 2006 title of “Breast Reconstruction with Prosthesis.” As to our proposed CY 2007 APC assignments, for these codes, the commenters indicated that the other procedures in APCs 0030 and 0029 did not use high cost devices, and the median costs of the various procedures assigned to these APCs violated the 2 times rule when the device-dependent median costs of CPT codes 19296 and 19297 were considered. The commenters further added that the procedures within these APCs were not clinically homogeneous and recommended that we reassign CPT codes 19296 and 19297 to APC 0648 (Breast Reconstruction with Prosthesis), which contained procedures that were more similar to the brachytherapy catheter insertion procedures in terms of their clinical characteristics and use of costly devices.

Response: As we have stated previously, we retain services within New Technology APC groups until we gather sufficient claims data to enable us to assign the services to clinically appropriate APCs. This policy allows us to move services from New Technology APCs in less than 2 years if sufficient data are available. It also permits us to retain services in New Technology APCs for more than 3 years if sufficient data upon which to base a decision for reassignment have not been collected. In the case of CPT codes 19296 and 19297, the predecessor codes for these services were created in April 2004. CPT code 19296 was previously described by HCPCS code C9715 (Placement of balloon catheter into the breast for interstitial radiation therapy following a partial mastectomy; delayed), and CPT code 19297 was described by HCPCS code C9714 (Placement of balloon catheter into the breast for interstitial Start Printed Page 68029radiation therapy following a partial mastectomy; concurrent/immediate). Both predecessor codes were assigned to New Technology APCs when the codes were announced in the April update of the CY 2004 OPPS (Transmittal 132, dated March 30, 2004). Specifically, HCPCS code C9715 was assigned to New Technology APC 1524 and HCPCS code C9714 was assigned to New Technology APC 1523. Consequently, we believe we have sufficient data from almost 3 years of hospital claims to assign both CPT codes 19296 and 19297 to clinically appropriate APCs. We recognize that, in the case of CPT code 19297 which is an add-on code to a partial mastectomy service, single bills would likely always be miscoded and available in only small numbers, because the correctly coded claims would be multiple procedure claims that we could not use for ratesetting.

However, in light of the comments received and our review of all the information provided by the commenters, we reconsidered the proposed APC assignments for CPT codes 19296 and 19297. We agree with the commenters that the clinical APC assignments for CPT codes 19296 and 19297 should accurately reflect the costs of the procedures, as well as their clinical features. We note that the final CY 2005 median cost for CPT code 19296 is $3,041.58 based on 537 (of 860 total) single claims, and the final CY 2005 median cost for CPT code 19297 is $1,322.03 based on 36 single claims (of 443 total claims). As noted previously, we do not believe the median cost of CPT code 19297 is calculated based upon correctly coded claims. Therefore, after full consideration of the public comments received, we believe it is appropriate for CY 2007 to assign both services to clinical APC 0648 with an APC title of “Level IV Breast Surgery” and a final median cost of $3,130.45. We believe this is the most appropriate assignment for both procedures, when we consider their clinical and resource characteristics in the context of other procedures also assigned to APC 0648.

APC 0648 is assigned status indicator “T,” which means that when a service assigned to it is reported with a lower priced service (for example, a mastectomy procedure) that is also assigned status indicator “T,” payment for the lower priced service would be reduced by 50 percent. This reduction in payment reflects the efficiencies that occur when a lower paid service is performed during the same operative session as a higher paid surgical procedure. We believe this reduction is appropriate due to efficiencies that may be gained when both services are performed in a single session. As for CPT code 19298, because there was no predecessor code to describe this procedure, which was new in CY 2005, we only have 1 year of claims data. Therefore, we are continuing to assign this code to New Technology APC 1524 for CY 2007 to enable us to collect additional data for appropriate ratesetting in the future.

Comment: Several commenters indicated that the procedure associated with CPT codes 19296 and 19297 requires the use of a specialized catheter that has a list price of $2,750, which is more costly than the proposed payment rate for APC 0030 or APC 0029. One commenter added that hospitals do not receive discounts or rebates on the unique catheters, and that regardless of whether the procedure is performed at the time of lumpectomy or during future surgery, the cost of the catheter is still the same in both cases.

Response: As noted above, after carefully considering all the public comments received, we have reassigned CPT codes 19296 and 19297 to APC 0648, a device-dependent APC, for CY 2007. The final median cost for this device-dependent APC was calculated using only claims that contained appropriate device HCPCS codes for all the procedures assigned to it with nontoken charges for the devices as discussed in section IV.A.2 of this preamble. The median cost from the subset of claims reporting a device HCPCS code for the brachytherapy catheter was $3,469.85 for CPT code 19296 and $3,379.97 for CPT code 19297. We believe that payment for APC 0648 accurately reflects the resources and costs associated with performing these device-dependent brachytherapy catheter insertion procedures. To ensure that their future claims include charges for the necessary devices to assist in ratesetting, we will implement procedure-to-device edits for both of these services in CY 2007. In order to receive payment for the two procedures to insert brachytherapy balloon catheters, hospitals will be required to report the appropriate device HCPCS code or their claims will be returned to them for correction.

Comment: Several commenters were concerned about the proposed assignment of status indicator “T” to both CPT codes 19296 and 19297. They observed that the indicator would always reduce the payment for CPT code 19297 by 50 percent.

Response: Based on the final CY 2007 assignment of CPT code 19297 to APC 0648, we believe this reduction is appropriate due to efficiencies that may be gained when both the partial mastectomy and placement of brachytherapy catheter procedures are performed in a single operative session. According to the CPT manual, CPT code 19297 would be reported with CPT code 19160 (Mastectomy, partial (e.g., lumpectomy, tylectomy, quadrantectomy, segmentectomy)) or 19162 (Mastectomy, partial (e.g., lumpectomy, tylectomy, quadrantectomy, segmentectomy); with axillary lymphadenectomy). These codes are assigned to APCs 0028 (Level I Breast Surgery), with a final CY 2007 median cost of $1,178.12, and 0693 (Breast Reconstruction), with a final CY 2007 median cost of $2,260.98, respectively. In cases where the partial mastectomy is performed with concurrent placement of a brachytherapy balloon catheter into the breast, payment for the nondevice-dependent partial mastectomy procedure would be appropriately reduced by 50 percent, while full payment would be provided for the device-dependent procedure described by CPT code 19297, consistent with the expected resource efficiencies when these procedures are performed in a single session.

After carefully considering all public comments received, we are finalizing our CY 2007 proposal with modification to reassign CPT codes 19296 and 19297 from New Technology APCs to clinical APC 0648, retitled “Level IV Breast Procedures,” with a final CY 2007 median cost of $3,130.45. We also are implementing appropriate procedure-to-device edits for both of these procedures.

(2) Radiofrequency Ablation (APCs 0050 and 0423)

For CY 2007, we proposed to reassign CPT code 20982 (Ablation, bone tumor(s) (e.g., osteoid osteoma, metastasis), radiofrequency, percutaneous, included computed tomographic guidance) from New Technology APC 1557 (New Technology—Level XX ($1800-$1900)) to APC 0050 (Level II Musculoskeletal Procedures Except Hand and Foot), with a proposed median cost of $1,535.66.

We also proposed that CPT code 50592 (Ablation, one or more renal tumor(s), percutaneous, unilateral radiofrequency), which was a new CPT code for CY 2006, and CPT code 47382 (Ablation, one or more liver tumor(s), percutaneous, radiofrequency) continue to be assigned to APC 0423 (Level II Percutaneous Abdominal and Biliary Procedures), with a proposed median cost of $2,410.33.

Comment: One commenter objected to the proposed payment for APC 0423 and Start Printed Page 68030the placement of CPT codes 47382 and 50592 in APC 0423 because the commenter believed that the proposed payment was too low to adequately compensate hospitals for the required radiofrequency electrode and the necessary services. One commenter also asked that CPT code 20982 be reassigned to APC 0051 (Level III Musculoskeletal Procedures Except Hand and Foot) to pay a more appropriate amount. The commenter provided a comparison to the MPFS practice expense inputs that showed that the supply, clinical time, and capital expense for performing CPT code 20982 was about $2,100. Moreover, the commenter asked that CMS ensure that a forthcoming CPT code for ablation of a lung tumor be assigned to an APC that would make appropriate payment for both the electrode and the services. The commenter stated that the electrodes used in these services typically cost from $900 to $2,500, with an approximate average of $1,500. The commenter asked that CMS grant its pass-through device category application, establish a new device category code for radiofrequency electrodes for pass-through payment, and designate APCs 0423, 0132 (Level III Laparoscopy), and 0050 as device-dependent APCs and implement appropriate procedure-to-device edits.

Response: The MPFS is a different payment system that establishes payment rates based on a methodology that is wholly unrelated to the OPPS setting of relative weights, so its practice expense costs are not applicable to the OPPS. However, in this final rule with comment period, we are reassigning CPT code 20982 to APC 0051 for CY 2007 because we agree, based on review of our historical claims data and final CY 2005 claims, that CPT code 20982 is more appropriately assigned to APC 0051 than to APC 0050 from hospital resource and clinical perspectives. However, we are retaining CPT codes 47382 and 50592 in APC 0423, with a median cost established based upon our standard OPPS methodology, because we believe that we have sufficient claims data for CPT code 47382, which was created in CY 2002. We have 4 years of claims data for this procedure, with hundreds of single claims from CY 2005 that reflect a stable code-specific median cost in comparison with CY 2004 claims. For CY 2007, CPT code 47382 is the only code assigned to APC 0423 that contributes claims data to the median cost calculation for the APC. We also believe that CPT code 50592, which has no CY 2005 claims data because it was new for CY 2006, is similar to CPT code 47382 based on clinical and resource considerations. Therefore, it is most appropriately assigned to the same clinical APC. Moreover, because CPT code 47382 uses devices that never had pass-through status, we have not placed any of the CPT codes for radiofrequency ablation procedures in specialized APCs, nor do we consider their APCs to be device-dependent. Because the device is well-established in its use for radiofrequency ablation of liver tumors, we believe that hospital charges for the procedure contain the charges the hospital considers are appropriate for the electrode and other required supplies. This is similar to our treatment of CPT code 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification)). This is a well-established service that predates the OPPS and that uses a device that was never a pass-through device. We also do not consider its APC to be device-dependent.

We also are assigning new CPT code 32998 (Ablation therapy for reduction or eradication of one or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, radiofrequency, unilateral) to APC 0423 because we have no reason to believe that the resources required for the newly coded service differ in any substantive way from the resources required for longstanding CPT code 49382. This new CPT code's assignment is open to comment in this final rule with comment period. We do not make pass-through device category determinations through rulemaking, nor do we create new device category codes outside of the pass-through process. Because there is no specific device code to describe the radiofrequency ablation electrode, we are unable to implement procedure-to-device edits for any of these procedures.

After carefully considering the public comments received, we are finalizing our proposal with modification. CPT code 20982 is reassigned to APC 0051 for CY 2007, with a median cost of $2,510.95. CPT codes 47382 and 50592 continue to be assigned to APC 0423 for CY 2007, with a median cost of $2,283.08. New CPT code 32998 is also assigned to APC 0423 for CY 2007, and this assignment is open to comment in this final rule with comment period.

(3) Extracorporeal Shock Wave Treatment (APC 0050)

For CY 2007, we proposed to reassign CPT code 28890 (Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia) and CPT code 0102T (Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle) from New Technology APC 1547 (New Technology—Level X ($800-$900)) to clinical APC 0050 (Level II Musculoskeletal Procedures Except Hand and Foot), which had a proposed payment rate of $1,542.47.

Comment: One commenter on our CY 2006 final rule with comment period was concerned that our assignment of new CPT code 28890 to APC 1547 may be insufficient to appropriately pay for the costs associated with its performance and facility costs in the outpatient setting. The commenter admitted that it did not have actual cost data for supplies and equipment used in the hospital outpatient setting. Nevertheless the commenter was concerned that the $850 payment rate for services assigned to APC 1547 may be insufficient for this service the OPD. The commenters on our CY 2007 OPPS proposed rule believed that our proposed reassignment of CPT codes 28890 and 0102T to APC 0050 was appropriate for CY 2007 until the Medicare hospital claims data become more robust. Several commenters supported our proposal to reassign CPT code 28890 and CPT code 0102T from New Technology APC 1547 to clinical APC 0050. The commenters believed that APC 0050 appropriately reflects the true costs and clinical resources associated with CPT code 0102T. One commenter indicated that the costs of the procedures currently classified under clinical APC 0050 are not dissimilar to the median cost of its predecessor code, specifically, HCPCS code C9720 (High-energy (greater than 0.22mj/mm2) extracorporeal shock wave (ESW) treatment for chronic lateral epicondylitis (tennis elbow)), and therefore, agreed with our proposed assignment. However, one commenter believed that the true resource costs of CPT codes 28890 and 0102T are not fully reflected in the CY 2005 claims data upon which CY 2007 payment rates are based. Therefore, the commenter recommended that CMS adopt the proposed assignments of these CPT codes to APC 0050, but that CMS continue to track and evaluate its claims data as additional claims data become available.

However, the commenter questioned our assignment of CPT code 0101T (Extracorporeal shock wave involving musculoskeletal system, not otherwise Start Printed Page 68031specified, high energy) to APC 0050, stating that this code describes a variety of unspecified procedures for which we have no CY 2005 claims data. The commenter recommended that we not assign CPT code 0101T to APC 0050 or to any inappropriately low-priced New Technology APC.

Response: Concerning the comment to our CY 2006 assignment of CPT code 28890, we note that the OPPS payment is for the technical or facility portion of the payment only. The physician performing the procedure would also bill CMS for the professional services in providing the procedure. Therefore, the CY 2006 OPPS payment for APC 1547 was not for both the performance and facility fee as suggested by the commenter. Nevertheless, in our proposed rule for CY 2007, we proposed reassigning CPT code 28890 to APC 0050, Level II Musculoskeletal Procedures Except Hand and Foot, with a proposed payment rate of $1,542.47. Prior to the introduction of this CPT code in CY 2006, hospitals reported HPCPS code C9721 (High-energy (greater than 0.22mj/mm2) extracorporeal shock wave (ESW) treatment for chronic plantar fasciitis), to describe the service. This C-code had a median cost of about $1,794 based on CY 2005 claims, consistent with the proposed payment rate for APC 0050.

We appreciate the support for our proposed reassignment of ESWT CPT codes 28890 and 0102T to APC 0050 for CY 2007. Concerning the objection to assigning CPT code 0101T to APC 0050 due to the lack of claims data, we believe that the clinical characteristics and expected resource use for CPT code 0101T will be similar to other ESWT treatments such as those described by CPT codes 28890 and CPT 0102T. As indicated in our CY 2007 OPPS proposed rule (71 FR 49549), some of the new Category III CPT codes describe services that we have determined to be similar in clinical characteristics and resource use to HCPCS codes in an existing APC. In these instances, we may assign the Category III CPT code to the appropriate clinical APC. In the case of CPT code 0101T, we believe this procedure is similar in clinical characteristics and resource use to CPT code 28890 and CPT code 0102T.

After carefully considering the public comments received, we are finalizing our proposal without modification to assign CPT codes 28890, 0102T, and 0101T to APC 0050 for CY 2007.

(4) Insertion of Venous Access Device With Two Ports (APC 0623)

For CY 2007, we proposed to reassign CPT code 36566 (Insertion of tunneled centrally inserted central venous access device, requiring two catheters via two separately venous access sites: with subcutaneous port(s)) from New Technology APC 1564 (New Technology—Level XXVII ($4500-$5000)), to APC 0623 (Level III Vascular Access Procedures), with a proposed median cost of $1,703.94. At its August 2006 meeting, the APC Panel recommended that this procedure be moved to an APC with a payment rate no less than that of New Technology APC 1524 (New Technology—Level XXIV ($3000-$3500)) and more than that of New Technology APC 1564 (New Technology—Level XXVII ($4500-$5000)). The APC Panel also recommended that CMS establish a procedure-to-device edit for the service.

Comment: Some commenters objected to the proposed payment rate for CPT code 36566. The commenters asked that CMS establish the median cost for this code based only on claims that contain HCPCS code C1881 (Dialysis access system, implantable) and that we add a device edit that requires that hospitals must bill for HCPCS code C1881 as a condition of being paid for CPT code 36566. They indicated that two devices, totaling $3,500, are required for the procedures.

Response: We agree that CPT code 36566, created in CY 2004, should be assigned to a device-dependent APC, and we calculated median costs for device-dependent APCs in CY 2007 based upon claims that passed the device edits and contained nontoken device charges as described in section IV.A.2 of this preamble. When we calculated the median cost of CPT 36566 based only on that subset of claims with HCPCS code C1881, its median cost was $5,100.26. We are generally accepting the APC Panel's recommendation to assign CPT code 36566 to an APC with an appropriate payment rate and to establish a procedure-to-device edit for CY 2007. For CY 2007, we have placed CPT code 36566 in new APC 0625 (Level IV Vascular Access Procedures) because there is no currently existing clinical APC where CPT code 36566 could appropriately be reassigned based on clinical and resource considerations. We have established APC 0625 as a device-dependent APC because the APCs for the vascular access device services that require devices of significant cost generally have been considered device-dependent since the inception of the OPPS. We have established a device edit, effective for services on or after January 1, 2007, that will not provide payment for CPT code 36566 unless an appropriate device HCPCS code is also reported on the claim. We have calculated the median cost of APC 0625 for CY 2007 using only claims that contain nontoken charges for HCPCS code C1881.

After carefully considering the public comments received, we are finalizing our CY 2007 proposal with modification. We are assigning CPT code 36566 to APC 0625, with a median cost of $5,100.26, and establishing an appropriate procedure-to-device edit for CY 2007.

(5) Stereotactic X-ray Guidance (APC 0257)

For CY 2007, we proposed to reassign CPT code 77421 (Stereoscopic x-ray guidance) from New Technology APC 1502 (New Technology—Level II ($50-$100)) to clinical APC 0257 (Level I Therapeutic Radiologic Procedures), with a proposed median cost of $60.

Comment: Some commenters expressed concern about our proposal to reassign CPT code 77421 from New Technology APC 1502 to clinical APC 0257. The commenters indicated that the proposed payment rate of $60.14 for APC 0257 was insufficient and did not adequately cover the actual costs associated with providing the guidance service described by CPT code 77421. In addition, the commenters believed that the other services currently assigned to APC 0257 were significantly different from CPT code 77421. The commenters stated that the stereotactic x-ray guidance procedure is considerately more sophisticated and technologically more complex, and thus, more resource intensive, than the procedures in APC 0257. Furthermore, the commenters cited the global payment rate of $151.59 for CPT code 77421 under the MPFS, and requested that we take into consideration the MPFS practice expense information for ratesetting rather than relying on very limited hospital claims data. Some commenters requested that CMS reassign CPT code 77421 to APC 0296 (Level II Therapeutic Radiologic Procedures), which had a proposed median cost of $167, to more accurately reflect the true costs associated with providing this service. The commenters further indicated that the other services assigned to APC 0296 were similar clinically and resource-wise to the stereotactic x-ray guidance procedure. Other commenters requested that CMS maintain CPT code 77421 in New Technology APC 1502 with a payment rate of $75 for CY 2007, until CMS has more experience with the CPT code. Some commenters noted that CMS may have mistakenly cross-walked CY 2005 claims data for C9722 (Stereoscopic kilovolt x-ray imaging Start Printed Page 68032with infrared tracking for localization of target volume) to CPT code 77421, based on the belief that both codes described the same services.

Response: While CPT code 77421 was made effective on January 1, 2006, under the OPPS stereoscopic kV x-ray guidance was previously reported with HCPCS code C9722, which was made effective January 1, 2005, and deleted on December 31, 2005, according to our usual practice when services previously described by a C-code can be reported with a CPT code. Based on our claims data, we found 14,794 single claims (out of 15,367 total claims) for HCPCS code C9722 in the CY 2005 data upon which we are basing the CY 2007 relative weights. We believe that services previously reported with HCPCS code C9722 may now be reported with CPT code 77421, although CPT code 77421 may allow reporting of a broader set of technologies. We also believe this CY 2005 volume of services is sufficient to justify setting a relative weight based on claims-based cost information rather than keeping the service in a New Technology APC for another year. In addition, our claims information is not consistent with a payment for the service through clinical APC 0296, which has a final median cost of about $164. We note that, of the claims available for ratesetting for APC 0257, almost 90 percent of them were for HCPCS code C9722; therefore, we are confident that the median cost of APC 0257 appropriately reflects the costs of stereoscopic x-ray imaging. We also believe the other imaging services assigned to APC 0257 share sufficient clinical and resource similarity with CPT code 77421 to support their assignment to the same clinical APC. Moreover, we again note that the MPFS practice expense information for this service is not relevant to the setting of relative weights under OPPS.

After considering all the public comments received, for CY 2007, we are adopting as final without modification our proposal to reassign CPT code 77421 from New Technology APC 1502 to clinical APC 0257, which has a final CY 2007 median cost of $67.06.

(6) Whole Body Tumor Imaging (APC 0408)

For CY 2007, we proposed to reassign CPT code 78804 (Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whole body, requiring two or more days imaging) from New Technology APC 1508 (New Technology—Level VIII ($600-$700)) to clinical APC 0408 (Level II Tumor/Infection Imaging) with a proposed median cost of $309.

Comment: Several commenters disagreed with the proposed reassignment of CPT code 78804, which describes a whole body study that requires multiple days of imaging, from New Technology APC 1508 to the same new clinical APC 0408 as the assignment of CPT code 78806 (Radiopharmaceutical localization of inflammatory process; whole body), which describes a single day whole body imaging study. While the commenters acknowledged that the two procedures use similar resources for a day of imaging, they stated that the clinical time and work involved in performing a multiple day imaging study is significantly more intensive than a single day study; therefore, hospitals incur additional costs. As such, the commenters disagreed with our proposal to assign the single and multiple day study CPT codes to the same clinical APC because the hospital resources are not homogeneous for these clinically similar studies. The commenters urged CMS to maintain the single day study as described by CPT code 78806 in its current APC assignment, specifically APC 0406 (Level I Tumor/Infection Imaging), and to create a new APC for CPT code 78804 for assignment of the multiple day study. Furthermore, the commenters recommended that the payment rate for CPT code 78804 be based on the current claims data for the procedure.

Response: After further review of our CY 2005 claims data and consideration of the clinical characteristics of CPT code 78804, we agree with the commenters' recommendation to maintain the single day study, which is described by CPT code 78806, in its current CY 2006 APC 0406. We further agree with the commenters' assignment of CPT code 78804 to a separate APC established as Level II Tumor/Infection Imaging, and therefore, have decided to keep this code as the only code assigned to APC 0408 for CY 2007. Based on our final revised policy, the CY 2007 median cost of APC 0408 is $362.05. The separate APC assignments for the single and multiple day tumor/infection imaging studies adequately achieve both clinical and resource coherence for the services in both APCs. Therefore, we are finalizing our proposed CY 2007 APC assignment of CPT code 78804 to new clinical APC 0408 for CY 2007, with modification to the proposal through reconfiguration of APC 0408 as described above.

(7) Gastroesophageal Reflux Test With pH Electrode (APC 0361)

For CY 2007, we proposed to reassign CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal attached telemetry ph electrode placement, recording, analysis and interpretation) from New Technology APC 1506 (New Technology—Level VI ($400-$500)) to clinical APC 0361 (Level II Alimentary Tests) with a proposed payment of $242.

Comment: One commenter disagreed with our proposal to reassign CPT code 91035 from New Technology APC 1506 to clinical APC 0361. The commenter believed that the proposed payment level of $242 for APC 0361 did not adequately reflect the cost of providing the service and that it did not appropriately differentiate between the two types of pH monitoring for detection of gastroesophageal reflux disease (GERD): capsule-based and catheter-based. (CPT code 91035 describes the capsule-based pH monitoring service while CPT code 91034 describes the catheter-based pH monitoring procedure.) The commenter believed that the resource costs for the two procedures are significantly different, and as such, each procedure should be placed in a separate APC to accurately reflect the costs of providing the services. The commenter indicated that the average cost of the capsule is about $184, which is significantly higher than the cost of the catheter used for pH monitoring that is priced at about $45. In addition, the commenter requested that CPT code 91035 be designated as a device-dependent procedure, and also requested that CMS establish a C-code for the capsule to appropriately track its cost. The commenter also requested that CMS compare the costs of single claims with claims that include an endoscopy procedure, with which the pH capsule procedure is very commonly performed, to ensure that all costs were captured and based on the most likely clinical scenario when determining the appropriate payment rate for CPT code 91035.

Response: Since April 2004, the procedure described by CPT code 91035 has been designated as a new technology service under the OPPS. While CPT code 91035 was not effective for reporting until January 1, 2005, its predecessor code, specifically HCPCS code C9712 (Insertion of a pH capsule for measurement and monitoring of gastroesophageal reflux disease, includes data collection and interpretation) was designated as a new technology service and assigned to New Technology APC 1506 from April 2004 until December 31, 2004, when the code was deleted and replaced with CPT code 91035. CPT code 91035 was then assigned to the same New Technology Start Printed Page 68033APC for CY 2005, with a payment rate of $450. As usual, in determining the initial payment level for this service, we took into consideration the costs associated with the procedure, including the necessary capsule device.

We do not believe that our claims data from CYs 2004 and 2005 demonstrate that the resources associated with a capsule-based pH monitoring procedure are significantly greater than those required for a catheter-based pH monitoring procedure, leading to their inappropriate assignments to the same clinical APC. Based on our CY 2005 claims data, the median costs for each procedure are relatively comparable: $260 for CPT code 91034 (based on 2,982 single claims) and $300 for CPT code 91035 (based on 1,160 single claims). We believe that both procedures are fairly similar in terms of device cost, clinical staff time, and other facility resources required for performing the procedures. We note that the median cost for CPT code 91035 was based upon 1,160 single claims out of 4,777 total claims for the procedure. While we understand that capsule-based pH monitoring is often initiated in association with an endoscopy procedure, we have no reason to believe that our median cost from single claims calculated according to our standard OPPS methodology understates the cost of the procedure. Indeed, we would expect that the resources could be less if the service were performed in association with another surgical procedure because of efficiencies, although there would be no payment reduction because APC 0361 has a status indicator of “X.”

With respect to designation of the procedure as device-dependent, we typically have only designated APCs as device-dependent in the context of historical payment adjustments provided for these APCs. Many device-intensive procedures appropriately reside in clinical APCs along with procedures that do not require expensive devices. Currently device HCPCS codes are only established when new pass-through device categories are approved. Therefore, we will not create a new device code to track charges for this particular device that has not had pass-through status. We expect that hospitals will include their charges for the cost of the capsule either in the line-item charge for the pH monitoring procedure or under a separate revenue code line on their claims.

Because we believe that the median cost of APC 0361 appropriately represents the costs and resources involved in performing both capsule-based and catheter-based pH monitoring procedures, and these services are clinically similar, we are finalizing our assignment of CPT code 91035 to APC 0361 for CY 2007 without modification.

(8) Home International Normalized Ratio (INR) Monitoring (APC 0604)

Since CY 2002, home INR monitoring services have been described by two G-codes, specifically G0248 and G0249, and have been assigned to New Technology APCs. These codes were created effective July 2002 in the context of a National Coverage Determination (NCD) that covers home INR monitoring for patients with mechanical heart valves on warfarin that have been anticoagulated for at least 3 months, who undergo an educational program on anticoagulation management and use of the device prior to its use in the home, and who perform self-testing no more than once a week. The G-codes have been assigned to New Technology APCs for 5 years. Generally, codes remain in New Technology APCs until we can determine an appropriate clinical APC, based on the median cost and clinical characteristics of the services described by the code. This usually ranges from approximately 2 to 3 years.

In CY 2002, G0248 and G0249 were assigned to a New Technology APC with a payment rate of $75. In CY 2003, these codes were reassigned to a New Technology APC with a payment rate of $150, and they have remained there since that time.

Our analysis of hospital data for Medicare single and multiple claims submitted from CY 2002 through CY 2005 indicates that these procedures are rarely performed by hospital outpatient facilities. For claims submitted from CY 2002 through CY 2005, our single claims data show that there were zero claims submitted during CYs 2002, 2003, and 2004, and in CY 2005, only nine single claims for G0248 and only seven for G0249 are available for ratesetting. Looking at total claims, from 2002 through 2004, we had fewer than 20 claims for each of the specific services.

In addition, the median costs for these codes are $95 for G0248 and $128 for G0249 based on CY 2005 claims. Because we received no single claims between CY 2002 and CY 2004 for these codes, we have no prior median cost data.

In the CY 2007 OPPS proposed rule (71 FR 49556), we proposed to assign both G0248 and G0249 to clinical APC 0604 (Level I Clinic Visits), with a proposed median cost of $49.93. We believe these assignments were appropriate based on both clinical and resource considerations, in the context of other services also proposed for assignment to APC 0604.

During the August 2006 APC Panel meeting, one presenter recommended that we either continue to assign G0248 and G0249 to a New Technology APC or move them to an appropriate clinical APC consistent with the clinical and resource cost characteristics of providing these services. This technology is used in monitoring the adequacy of anticoagulation in patients taking warfarin to prevent major thromboembolic events. The presenter indicated that providers have been slow to adopt the technology because they must purchase the monitors and materials. The presenter requested that the codes remain in New Technology APCs or be reassigned to clinical APCs that appropriately make payments for the costs of providing the services, so that use of this technology increases and more data can be collected. The Panel agreed that providing payment at an appropriate rate would encourage more use of home INR monitoring, which would actively engage patients in their own care. The Panel recommended that we assign G0248 and G0249 to APC 0421 (Prolonged Physiologic Monitoring) for CY 2007.

Comment: One commenter expressed concern regarding our proposal to move home INR monitoring from New Technology APC 1503 (New Technology—Level III ($100-$200)) to clinical APC 0604. The commenter was particularly concerned that the proposed clinical APC 0604, which has a payment rate of $49.75, would not compensate for the costs incurred in delivering this service. While the commenter understood the reason for assigning these codes to a clinical APC because these codes have been assigned to a New Technology APC since July 2002 (these codes were made effective in July 2002 and announced through the OPPS July 2002 update, specifically Transmittal A-02-050, dated June 17, 2002), the commenter stated that the technology is fairly new with only a small number of hospital claims, which could therefore warrant its continued assignment to the current New Technology APC 1503. The commenter also indicated that the assignments of HCPCS codes G0248 and G0249 to clinical APC 0604 were neither economically nor clinically coherent because none of the other procedures also proposed for assignment to APC 0604 involved the furnishing of equipment and supplies to patients for use in their homes or involved care extended over a 4-week period. Therefore, the commenter urged CMS to maintain home INR monitoring services Start Printed Page 68034in New Technology APC 1503 with a payment rate of $150 for at least one more year. Alternatively, the commenter requested that CMS assign these codes to clinical APC 0421, which had a proposed payment rate of $101.47, because the reimbursement rate more closely corresponded with the costs of providing the services, and also with the clinical characteristics of the other procedure already assigned to this same APC.

Response: As we indicated above, the APC Panel also recommended that these two HCPS codes be assigned to APC 0421 for CY 2007. We agree with both the commenter and the APC Panel's recommendation to assign these codes to APC 0421.

Therefore, we are finalizing our proposed movement of HCPCS codes G0248 and G0249 from New Technology APC 1503 to a clinical APC for CY 2007 with modification. Effective January 1, 2007, HCPCS codes G0248 and G0249 will be assigned to APC 0421, with a final median cost of $99.43.

(9) Tositumomab Administration and Supply (APC 0442)

For CY 2007, we proposed to assign HCPCS code G3001 (Administration and supply of tositumomab, 450 mg) from New Technology APC 1522 (New Technology—Level XXII ($2000-$2500)) to clinical APC 0442 (Dosimetric Drug Administration), which had a proposed median cost of $1,515.80.

Comment: Several commenters, including a pharmaceutical company, expressed concern with the CMS proposal to assign HCPCS code G3001 from New Technology APC 1522 with a payment rate of $2,250 to clinical APC 0442. The commenters were concerned that the payment rate of $1,510.52 that was proposed for APC 0442 would not adequately cover both the cost of the product and the administration of the product itself since the WAC for the tositumomab product was approximately $2,189. They requested that CMS maintain the current payment rate for G3001 of $2,250 for CY 2007. Furthermore, one commenter recommended that HCPCS code G3001, currently applicable to both doses of the non-radioactive component of therapy and its administration, be amended to apply only to the unlabeled tositumomab product. The commenter urged CMS to assign a specific code that describes the unlabeled tositumomab to enable appropriate payment for the product. The commenter added that unlabeled tositumomab alone is only FDA approved as part of the overall BEXXAR therapeutic regimen, and therefore cannot be used other than as part of BEXXAR therapy. The commenter also recommended CMS permit hospitals to use a CPT code for the 1-hour administration of the nonradioactive component of BEXXAR.

Response: We first established G3001 in CY 2003. As we stated in the CY 2004 OPPS final rule with comment period (68 FR 63443), unlabeled tositumomab is not approved as either a drug or a radiopharmaceutical, but it is a supply that is required as part of the BEXXAR treatment regimen. We do not make separate payment for supplies used in services provided under the OPPS. Payments for necessary supplies are packaged into payments for the separately payable services provided by the hospital. Administration of unlabeled tositumomab is a complete service that qualifies for separate payment under its own APC. This complete service is currently described by HCPCS code G3001. Therefore, we do not agree with the commenter's recommendation that we assign a separate code to the supply of unlabeled tositumomab, which would not then receive separate payment. Rather, we will continue to make separate payment for the administration of tositumomab through G3001, and payment for the supply of unlabeled tositumomab is packaged into the administration payment.

Based on our CY 2005 claims data that show a final median cost of $1,367 for APC 0442, which contains only the service described by G3001, we had 148 single claims for the service. The median cost of G3001 from CY 2004 claims is $1,210 based on 69 single claims. We expect the annual volume of this service to Medicare beneficiaries to remain modest. By CY 2007, G3001 service will have been assigned to a New Technology APC for 3 years, providing two full years of claims data for our analysis. We believe that the final CY 2007 median cost of APC 0442 accurately reflects the hospital resources required to perform the administration and supply of tositumomab service, and that our data are sufficient at this point to support movement of G3001 out of a New Technology APC and into an appropriate clinical APC for CY 2007. Consequently, we are finalizing the proposed CY 2007 reassignment of HCPCS code G3001 from New Technology APC 1522 to clinical APC 0442, without modification.

(10) Summary of Other New Technology Procedures Assigned to Clinical APCs for CY 2007

After carefully considering all of the public comments received, we are adopting our proposal to reassign the new technology procedures to clinically appropriate APCs with modification to the final APC assignments for CPT codes 19296, 19297, 20982, 36566, and 78804 as shown in Table 10 below.

Start Printed Page 68035

D. APC-Specific Policies

1. Radiology Procedures

a. Radiology Procedures (APCs 0333, 0662, and Other Imaging APCs)

At its March 2006 meeting, the APC Panel made three recommendations regarding radiology services. These included the following:

  • Reaffirmed the CY 2005 recommendation that CMS postpone implementation of the multiple procedure reduction policy for imaging services as included in the CY 2006 OPPS proposed rule for CY 2007, to allow CMS to gather more data on the efficiencies associated with multiple imaging procedures that may already be reflected in the OPPS payment rates for imaging services.
  • Recommended that CMS review payment rates for computed tomography (CT) and computed tomographic angiography (CTA) procedures to ensure that their payment rates are comparatively consistent and that they accurately reflect resource use.
  • Recommended that CMS invite comments on ways that hospitals can uniformly and consistently report charges and costs related to radiology services.

In the CY 2006 OPPS final rule with comment period (70 FR 68707), we indicated that, based on the APC Panel's recommendations and public comments received, we decided not to finalize our CY 2006 proposal to reduce OPPS payments for some second and subsequent diagnostic imaging procedures performed in the same session. Our analyses did not disprove the commenters' contentions that there are efficiencies already reflected in their hospital costs, and, therefore, in their CCRs and the median costs for the procedures. As noted in the CY 2007 OPPS proposed rule (71 FR 49567), over the past 7 months, we have conducted additional studies of our hospital claims data for single and multiple diagnostic imaging procedures, and our analyses support continued deferral for CY 2007 of implementation of a multiple imaging procedure payment reduction policy in the OPPS. Therefore, we accepted the APC Panel's recommendation to not adopt such a policy for CY 2007 pending the results of further analyses. Depending upon the findings from such studies, in a future rulemaking we may propose revisions to the structure of our rates to further refine these rates in the context of additional study findings.

We received numerous public comments concerning our proposal. A summary of the comments and responses follow:

Comment: Numerous commenters supported the CMS proposal to defer implementing a multiple imaging Start Printed Page 68036procedure payment reduction policy in the OPPS for CY 2007. A number of commenters reiterated that CMS should never implement such a policy in the OPPS, based on the inherent characteristics of the standard methodology that is used to establish OPPS payment rates that already captures the efficiencies of these multiple services in the CCRs used to convert charges to costs on hospital claims. They argued that such discounting is not needed and unwarranted, because discounting has already been considered in setting the APC weights.

Response: We continue to be concerned about making appropriate payments for imaging services in the common circumstances where multiple procedures using the same imaging modality are provided in the same encounter. We will continue to study our single and multiple outpatient hospital claims for diagnostic imaging procedures and consider refinements to our payment rates for these services if results from the analyses suggest that changes to our payment policies would provide more accurate payments for these services.

After carefully considering the public comments received, we are adopting our proposal to defer implementation of a multiple imaging procedure payment reduction for CY 2007, without modification.

As indicated in the CY 2007 OPPS proposed rule (71 FR 49568), we also accepted the APC Panel's recommendation to review the CY 2007 proposed payment rates for CT and CTA procedures to ensure that their rates were comparatively consistent and accurately reflective of hospitals' resource costs. Presenters at the March 2006 APC Panel meeting indicated to the Panel that hospital resources for CTA procedures were similar to those for CT procedures that included scans without contrast followed by scans with contrast, but additional resources were required for the 3-dimensional reconstruction that was part of the CTA procedures. As a result of this image postprocessing, CTA scans displayed the vasculature in a 3-dimensional format rather than in the 2-dimensional cross-sectional images of conventional CT scans. As indicated in our CY 2007 proposed rule (71 FR 49568), based upon CY 2005 claims data, the CY 2007 proposed median cost for APC 0333 for CT procedures that included scans without contrast material, followed by contrast scans to complete the studies was $309, and the CY 2007 proposed median cost for APC 0662 for CTA procedures was $304. As has been the case for the past several years, the proposed median costs associated with these two APCs were virtually identical to one another and were also quite consistent with their historical costs from prior years of claims data. The CY 2007 proposed median costs for APCs 0333 and 0662 were based on about 500,000 and 150,000 single claims, respectively. The stability of these APC median costs, based on large numbers of single claims, was consistent with our belief that the median costs of these APCs accurately reflected hospitals' resource use. From CY 2004 to CY 2005, the number of CTA procedures performed in the outpatient department increased by 50 percent, whereas the number of CT procedures that included a scan without contrast followed by a scan with contrast to complete each full study increased by only about 1 percent. The large annual increases in the OPPS frequencies of CTA procedures through CY 2005 provided no evidence that Medicare beneficiaries were experiencing difficulty accessing these services in the hospital outpatient setting. CTA procedures were being more commonly performed for various clinical indications, likely resulting in more consistent and efficient use of the associated image postprocessing technology. Accordingly, it is not surprising that the hospital costs of typical CTA procedures in contemporary medical practice were very similar to the hospital costs of the more involved and resource-intensive complex CT services that, like CTA procedures, included scans without contrast material, followed by scans with contrast. Thus, we indicated in the CY 2007 proposed rule that we believed that our CY 2007 proposed payment rates for CT and CTA procedures were generally consistent with one another and accurately reflective of hospitals' resource costs.

We received several comments concerning our proposal. A summary of the comments and our responses follows:

Comment: Several comments on our proposed payment rate of $302.85 for the CTA procedures placed in APC 0662 (CT Angiography) indicated that the CTA procedures were reimbursed at a lower rate than conventional CT procedures, although the utilization costs of CTA exceeded conventional CT. The commenters urged CMS to set the payment for APC 0662 at a rate equal to the sum of APC 0333 (Computerized Axial Tomography and Computerized Angiography without Contrast followed by Contrast), which had a proposed payment rate of $307.88, and the postprocessing APC, specifically, APC 0282 (Miscellaneous Computerized Axial Tomography), which had a proposed payment rate of $95.72. Alternatively, the commenters suggested that CMS reassign the CTA procedures from APC 0662 to an existing APC that more closely reflected the resource costs of performing the procedures.

Response: While we acknowledge the commenters' concerns, we believe that our claims data accurately reflect the resource costs associated with providing the CTA services. As we stated in the November 15, 2004 final rule with comment period (69 FR 65722) and further reiterated in the November 10, 2005 final rule with comment period (70 FR 68597), accurate cost information about the costs of image reconstruction for CTA specifically, and for CT alone as utilized with CTA, would be required in order to implement one commenter's suggestion that we make the payment rate for CTA (APC 0662) equal to the sum of the rates for CT alone (APC 0333) plus image reconstruction (APC 0282). However, such cost information is still not available.

We have had several years of robust claims data for CTA procedures, whose code descriptors by definition include the required CT scans and image postprocessing, and have no reason to doubt these data. Based on the full year of CY 2005 data, we note that the median cost of $295.80 for APC 0333 (CT) is almost equal to the median cost of $296.70 for APC 0662 (CTA). Moreover, for specific reasons cited in the CY 2006 OPPS final rule (70 FR 68599), we are not reassigning the CTA procedures to any other clinical APC(s) for CY 2007. We believe that APC 0662 is quite homogeneous and see no other clinical APC where these services could be appropriately assigned based on clinical and resource considerations. We will apply the same standard OPPS ratesetting methodology for CY 2007 that we used for CY 2006 in establishing the payment rate for CTA procedures residing in APC 0662.

After carefully considering the public comments received, we are finalizing our proposal for payment of APCs 0333 and 0662 based on their median costs established according to the standard OPPS methodology, without modification.

With respect to the APC Panel's recommendation regarding the reporting of costs and charges for radiology services, as we noted in the proposed rule, CMS requires hospitals to report their costs and charges through the cost report with sufficient specificity to support CMS' use of cost report data for monitoring and payment. Within generally accepted principles of cost Start Printed Page 68037accounting, we allow providers flexibility to accommodate the unique attributes of each institution's accounting systems. For example, providers must match the generally intended meaning of the line-item cost centers, both standard and nonstandard, to the unique configuration of department and service categories used by each hospital's accounting system. Also, while the cost report provides recommended bases of allocation for the general services cost centers, a provider is permitted, within specified guidelines, to use an alternative basis for a general service cost if it can justify to its fiscal intermediary that the alternative is more accurate than the recommended basis. This approach creates internal consistency between a hospital's accounting system and the cost report, but cannot guarantee the precise comparability of costs and charges for individual cost centers across institutions.

However, in the CY 2007 proposed rule, we indicated that we believed that achieving greater uniformity by, for example, specifying the exact components of individual cost centers, would be very burdensome for hospitals and auditors. Hospitals would need to tailor their internal accounting systems to reflect a national definition of a cost center. It was not clear that the marginal improvement in precision created by such a requirement would justify the additional administrative burden. We believed that the current hospital practice of matching costs to the general intended meaning of a cost center ensures that most services in the cost center would be comparable across providers, even if the precise composition of a cost center among hospitals differed. Further, every hospital provides a different mix of services. Even if CMS specified the components of each cost center, costs and charges on the cost report would continue to reflect each individual hospital's mix of services. At the same time, internal consistency is very important to the OPPS. Costs are estimated on claims by matching CCRs for a given hospital to their own claims data through a cost center-to-revenue code crosswalk. OPPS relative weights are based on the median cost for all services in an APC. The components resulting in CCRs for a given revenue code would have to be dramatically different for the providers contributing the majority of claims used to calculate an APC's median cost in order to impact relative weights.

We accepted the APC Panel's recommendation and specifically invited comments on ways that hospitals can uniformly and consistently report charges and costs related to all cost centers, not just radiology, that also acknowledge the ubiquitous tradeoff between greater precision in developing CCRs and administrative burden associated with reduced flexibility in hospital accounting practices.

We received a number of public comments concerning this APC Panel recommendation. A summary of the comments and our responses follows:

Comment: Several commenters agreed that any steps taken to ensure greater uniformity in the reporting of costs and charges would have to carefully balance the additional administrative burden and loss of flexibility in hospitals' accounting practices. They noted that the difficulty in applying CCRs to arrive at hospital costs is that this requires assumptions of consistency in the relationship of HCPCS codes and revenue codes to revenue center service categories on the cost report. However, the cost report recognizes service categories that reflect the general descriptions of a hospital's service categories, but services that were at one time performed in a specific department of the hospital may now be performed in many departments of hospitals. The commenters noted that inconsistencies occur when determining the cost of a service if the CCR utilized in the calculation is from a different cost report service category than where the service was actually performed. The commenters also urged CMS to recognize the limitations and inconsistencies in the preparation of hospital cost reports, attributable to both hospital and fiscal intermediary behavior. They urged CMS to proceed with care in instructing hospitals because hospitals need the flexibility to set charges and allocate costs in a manner that makes the most sense for the particular hospital based on the mix of services it provides. The commenters noted that even small changes in practice and procedures require significant systems changes, and that CMS should allow time for dissemination of any such changes, coupled with significant provider education.

Response: We appreciate the commenters' observations. We will continue to reflect on the delicate balance between greater accuracy in developing CCRs to convert charges to costs under the OPPS and the needs of hospitals for flexibility in their accounting practices.

After carefully considering the public comments received, we will continue to seek input on this balance as we work on refining the OPPS payment system to pay more accurately for outpatient hospital services.

For CY 2007, we did not propose to make any changes from CY 2006 in our proposed APC assignments of CT, magnetic resonance imaging (MRI), and magnetic resonance angiography (MRA) services, preserving the longstanding APC groupings of these services. In particular, CT services were assigned to APCs 0332 (Computed Tomography without Contrast), 0283 (Computed Tomography with Contrast Material), and 0333 (Computed Tomography without contrast followed by Contrast) based upon their nature as studies without contrast, with contrast, and without contrast followed by contrast, respectively. MRI and MRA procedures were assigned to APCs 0336 (Magnetic Resonance Imaging and Magnetic Resonance Angiography without Contrast), 0284 (Magnetic Resonance Imaging and Magnetic Resonance Angiography with Contrast), and 0337 (Magnetic Resonance Imaging and Magnetic Resonance Angiography without Contrast followed by Contrast) based upon their characteristics as studies without contrast, with contrast, and without contrast followed by contrast, respectively.

Comment: One commenter requested that CMS revise the established CT, MRI, and MRA APC groupings to create greater internal clinical and resource consistency. The commenter believed that diagnostic services performed in the same anatomical region have similar resource utilization and should, therefore, be assigned to the same APC grouping. The commenter recommended that CMS differentiate among these services based on two body regions, the core (including the head, neck, thorax, spine, chest, abdomen, and pelvis) and the extremities (including the orbit/ear/fossa, maxillofacial region, upper extremity, and lower extremity). The commenter argued that because the OPPS was being used as the benchmark established by the DRA to limit payment for imaging services under the MPFS, this refinement would assist in ensuring even greater resource similarity of procedures within imaging APCs to establish more accurate payment rates under both the OPPS and the MPFS.

Response: We examined the current APC structure for CT, MRI, and MRA services and observed that there were no violations of the 2 times rule in any of the APCs. The median costs of the services assigned to each APC were relatively close, and we did not identify any code-specific patterns of significantly increased or decreased Start Printed Page 68038costs based on the specific anatomical region of the body imaged. We believe these APCs as currently structured contain services that are quite homogeneous with respect to their clinical and resource characteristics. The OPPS provides payments for APC groups of closely related procedures, and the current imaging groups provide appropriate payments for these services in a manner that is consistent with the payment policies of the OPPS. Accordingly, we see no reason to further distinguish CT, MRI, and MRA procedures into even smaller, more refined groupings. We also do not believe it would be appropriate to adjust these APC groups in order to affect the payments for CT, MRI, and MRA procedures under the MPFS.

After carefully considering the public comment received, we are finalizing our CY 2007 proposal for payment of CT, MRI, and MRA procedures, without modification. b. Computerized Reconstruction (APC 0417)

We proposed to assign HCPCS code G0288 (Reconstruction, computed tomographic angiography of aorta for surgical planning for vascular surgery) to APC 0417 (Computerized Reconstruction) for CY 2007, with a proposed median cost of $192.34. This was the same APC assignment as CY 2006, and this service is the only service assigned to the APC.

Comment: One commenter strongly opposed the proposed payment amount for CY 2007 for HCPCS code G0288. The commenter stated that the OPPS proposed payment amount was not nearly enough to cover the hospital's costs for providing this important service. The commenter believed that implementation of the proposed payment would jeopardize the quality of the HCPCS code G0288 procedures that are performed, limit beneficiary access to the services, and result in postoperative complications due to implantation of poorly fitting stents.

Response: The payment amount proposed for the APC 0417, to which HCPCS code G0288 is the only service assigned, is based on the median cost from 6,028 single claims for this one service. We are confident that these data provide an accurate representation of hospital costs for providing the service. We note that despite reductions in payment rates over the last several years, the number of total procedures billed under the OPPS for HCPCS code G0288 has risen steadily from 2,065 in CY 2002, to 4,733 in CY 2003, to 8,421 in CY 2004, and most recently to 9,395 in CY 2005. We have no evidence that Medicare beneficiaries are having trouble accessing this service based on our hospital claims information. We believe that it is appropriate for us to use our historical hospital cost data as the basis for the CY 2007 payment amount. Therefore, we are finalizing our CY 2007 payment rate for APC 0417 based on a median cost of $197.95.

c. Cardiac Computed Tomography and Computed Tomographic Angiography (APCs 0282, 0376, 0377, and 0398)

In Addendum B of the CY 2007 proposed rule (71 FR 49832), we proposed to assign the eight cardiac computed tomography (CCT) and computed tomographic angiography (CCTA) Category III CPT codes to the APCs as shown in Table 11 below. These services were new for CY 2006, and we did not propose any changes to their APC assignments for CY 2007.

Table 11.—Proposed CY 2007 APC Assignments for CCT and CCTA Category III CPT Codes

CPT codeDescriptorProposed CY 2007 APC assignmentProposed CY 2007 APC assignment payment rate
0144TCT heart wo dye; qual calc0398$261.66
0145TCT heart w/wo dye funct0376306.34
0146TCCTA w/wo dye0376306.64
0147TCCTA w/wo, quan calcium0376306.34
0148TCCTA w/wo, strxr0377415.12
0149TCCTA w/wo, strxr quan calcium0377415.12
0150TCCTA w/wo, disease strxr0398261.66
0151TCT heart funct add-on028295.72

Comment: Several commenters requested that CMS remove the APC assignments for the eight CCT and CCTA procedures because these codes fall within the Category III CPT code section, and because they are carrier-priced and not assigned any relative value units under the MPFS. The commenters believed that the Deficit Reduction Act MPFS provisions should not apply to these procedures.

Response: As we stated in a section III.A.2. of this CY 2007 OPPS final rule with comment period, we implement Category III codes that are released by the AMA in July of a given year for implementation in January of the next year by providing them with new interim assignments in the OPPS final rule for the next update year. These CCT and CCTA codes were released in July 2005 for implementation in January 2006. We received no public comments on their interim final APC assignments published in Addendum B of the CY 2006 OPPS final rule with comment period. As we indicated in our CY 2007 OPPS proposed rule (71 FR 49549), some Category III CPT codes describe services that we have determined to be similar in clinical characteristics and resource use to HCPCS codes in an existing APC. In these instances, we may assign the Category III CPT code to the appropriate clinical APC. Other Category III CPT codes describe services that we have determined are not compatible with an existing clinical APC, yet are appropriately provided in the hospital outpatient setting. In these cases, we may assign the Category III CPT code to what we estimate is an appropriately priced New Technology APC. In other cases, we may assign a Category III CPT code to one of several nonseparately payable status indicators, including “N,” “C,” “B,” or “E,” which we believe is appropriate for the specific code. We believe that CCT and CCTA procedures are appropriate for separate payment under the OPPS should local contractors provide coverage for these procedures, and, therefore, they warrant status indicator and APC assignments that would provide separate payment under the OPPS. MPFS concerns regarding payment limitations for these procedures are outside the scope of this final rule with comment period.

Comment: Many commenters expressed their appreciation of our recognition of the CPT codes as separately payable services under the OPPS; however, they believed that the CCTA Category III CPT codes (0144T Start Printed Page 68039through 0151T) should be moved from APCs 0282, 0376, 0377, and 0398, to appropriate New Technology APCs so that adequate hospital claims data could be gathered. They provided specific recommendations for the New Technology APC assignments of these services. These same commenters added that once CMS has acquired adequate claims data, pricing information could be used to separate and incorporate the various Category III CCTA CPT codes into clinical APCs. Some commenters were also concerned that CCT and CCTA procedures were not clinically homogeneous with other procedures currently assigned to APCs 0282, 0376, 0377, and 0398, noting that the last three APCs previously contained only nuclear medicine cardiac imaging procedures.

Response: We appreciate the suggestions submitted by the commenters. However, as we indicated above, some of the new Category III CPT codes describe services that we have determined to be similar in clinical characteristics and resource use to HCPCS codes in an existing APC. In these instances, we may assign the Category III CPT code to the appropriate clinical APC. In the case of these eight CCT and CCTA procedures, we believe that their clinical characteristics and resource use are similar to the other procedures assigned to APCs 0282, 0376, 0377, and 0398. We have not limited APCs 0376, 0377, and 0398 solely to nuclear medicine cardiac imaging services. We believe that cardiac imaging services using different modalities may be appropriate for assignment to the same clinical APCs, based on their clinical and resource characteristics. The OPPS is a prospective payment system that provides payment for services based on their assignment to APC groups, and, as such, we think the proposed APC assignments for these CCT and CCTA services, which are the same as their CY 2006 interim final assignments, are appropriate. While we understand that use of CCT and CCTA to image the heart are relatively new applications of specifically refined technology, cardiac imaging using other modalities is already well-established, as is the noncardiac use of CT and CTA. Therefore, for CY 2007, we are continuing with our proposal to assign Category III CPT codes 0144T through 0151T to clinical APCs 0282, 0376, 0377, and 0398. We expect to have claims data for these procedures available for the CY 2008 OPPS update.

After carefully considering the public comments received, we are finalizing our proposal without modification to assign CPT codes 0144T through 0151T to APCs 0282, 0376, 0377, and 0398, all with status indicator “S.”

d. Radiologic Evaluation of Central Venous Access Device (APC 0340)

For CY 2006, new CPT code 36598 (Contrast injection(s) for radiologic evaluation of existing central venous access device, including fluoroscopic guidance) was assigned to APC 0340 (Minor Ancillary Procedures) on an interim final basis. The proposed assignment of the code for CY 2007 was unchanged.

Comment: One commenter requested that CMS assign new CPT code 36598 to APC 0263 (Level I Miscellaneous Radiology Procedures) for CY 2007. The commenter stated that the procedure reported by CPT code 36598 is very similar to that which is coded using CPT code 76080 (Radiologic examination, abscess, fistula or sinus tract study, radiological supervision and interpretation), which is assigned to APC 0263 for CY 2006. Further, the commenter stated that the use of contrast and fluoroscopy makes CPT code 36598 more resource intensive than the other procedures assigned to APC 0340, where CMS assigned it with an interim final status for CY 2006.

Response: We will not have data upon which to base our decisions about the APC assignment for this procedure until next year. However, based on our data for many procedures that we believe are similar to that coded by CPT code 36598, we believe that assignment to APC 0340 is appropriate and do not believe that it is appropriate to reassign it to another APC at this time.

We are maintaining the assignment of CPT code 36598 to APC 0340 for CY 2007 and will reevaluate that assignment when data become available.

2. Nuclear Medicine and Radiation Oncology Procedures

a. Myocardial Positron Emission Tomography (PET) Scans (APC 0307)

From August 2000 to December 31, 2005, under the OPPS we assigned to one clinical APC all myocardial positron emission tomography (PET) scan procedures, which were reported with multiple G-codes through March 31, 2005. Effective April 1, 2005, myocardial PET scans were reported with three CPT codes, specifically CPT codes 78492 (Myocardial imaging, positron emission tomography (PET), perfusion; multiple studies at rest and/or stress), 78459 (Myocardial imaging, positron emission tomography (PET), metabolic evaluation), and 78491 (Myocardial imaging, positron emission tomography (PET), perfusion; single study at rest or stress) under the OPPS. Public comments on the CY 2006 OPPS proposed rule suggested that the HCPCS codes describing multiple myocardial PET scans should be assigned to a separate APC from single study codes because their hospital resource costs are significantly higher than single scans. Review of the CY 2004 claims data for myocardial PET scans revealed a median cost of $2,482 for the 9 G-codes that describe multiple myocardial PET scans, based upon 978 single claims of 2,001 total claims for multiple scan procedures. The CY 2004 claims data showed a median cost of $800 for the 6 G-codes describing single PET studies, based on 391 single claims of 575 total claims. A review of CY 2003 claims data showed a similar pattern of significantly higher hospital costs for multiple myocardial PET studies in comparison with single studies, although there were fewer claims for the procedures in CY 2003 in comparison with CY 2004. In response to the comments received and based on this claims information, myocardial PET services were assigned to two clinical APCs for the CY 2006 OPPS. HCPCS codes for single scans were assigned to APC 0306 with a payment rate of $800.55, and HCPCS codes for the multiple scan procedures were assigned to APC 0307 (Myocardial Positron Emission Tomography (PET) Imaging) with a payment rate of $2,484.88.

Analysis of the CY 2005 claims data for myocardial PET scans for the CY 2007 proposed rule revealed that the APC median costs for the single and multiple myocardial PET codes were $836 and $680 respectively, based on 296 single claims for single studies and 1,150 single claims for multiple scan procedures. Despite more CY 2005 single claims for multiple scan procedures, the median cost of these procedures declined significantly from CY 2004 to CY 2005, dropping below the median cost of single studies. As indicated earlier, there was a significant coding change for myocardial PET services in CY 2005, with the reporting of a single CPT code for multiple studies (CPT code 78492), in comparison with nine G-codes in CY 2004. We examined the single bills for multiple scan procedures from CY 2004 and noted 17 hospitals were represented, with the majority of those claims from a single hospital. In contrast, in the CY 2005 claims, 25 hospitals were represented in the single bills for multiple scan procedures, and no single hospital contributed a majority of claims to the median cost calculation. We also Start Printed Page 68040examined differences in charges associated with G-codes versus the CPT code to determine if hospitals had adjusted the charge for the CPT code to reflect the termination of the multiple study G-codes. However, the individual charging practices of hospitals did not appear to vary with the use of a G-code versus the CPT code in either the CY 2004 or the CY 2005 claims. Greater volume of claims and consistent charging for both the G-codes and CPT code by hospitals suggested that the median appropriately captured the greater variability in relative hospital costs for multiple myocardial PET studies in the CY 2005 claims data.

Based on these claims data, we believe that it is apparent that the use of myocardial PET scan technology had become more widely prevalent in hospitals, and as a result, we had more data to support our proposed payment rates. We believed that the median costs from our CY 2005 claims data for myocardial PET scan services, calculated based upon our standard OPPS methodology and based on almost 1,600 single claims, for both the single and multiple scans, were reflective of the hospital resources required to provide the services to Medicare beneficiaries in the outpatient hospital setting. Based on those data, we concluded in the CY 2007 proposed rule that the differential median costs of the single and multiple study procedures did not support the two-level APC payment structure. Although we acknowledged that some individuals may believe that multiple scan procedures should require increased resources at some hospitals in comparison with single scans, particularly because of the longer scan times required for multiple studies, we noted that our data did not support a resource differential that would necessitate the placement of these single and multiple scan procedures into two separate APCs. As myocardial PET scans are being provided more frequently at a greater number of hospitals than in the past, we believed that it was possible that most hospitals performing multiple PET scans were particularly efficient in their delivery of higher volumes of these services and, therefore, incurred hospital costs that were similar to those of single scans, which were provided less commonly. In fact, the CPT code for multiple scans had a lower median cost than either of the CPT codes for single procedures.

When all myocardial PET scan procedure codes were combined into a single clinical APC, as they were prior to CY 2006, the CY 2007 proposed rule APC median cost for myocardial PET services was about $727, very similar to the $703 median cost of their single CY 2005 clinical APC. Therefore, for CY 2007, we proposed to assign CPT codes 78459, 78491, and 78492 to a single APC, specifically, APC 0307. We believed that the assignment of these three CPT codes to APC 0307 was appropriate, as the CY 2005 claims data revealed that more hospitals were providing multiple myocardial PET scan services, most myocardial PET scans were multiple studies, and the hospital resource costs of single and multiple studies were similar. We believed that the proposed median cost appropriately reflected the hospital resources associated with providing myocardial PET scans to Medicare beneficiaries in cost-efficient settings. Further, we believed that the proposed rates were adequate to ensure appropriate access to these services for Medicare beneficiaries. We specifically invited comments on our proposal to provide a single payment rate for all myocardial PET scans in CY 2007. The myocardial PET scan CPT codes and their CY 2007 proposed APC assignments were displayed in Table 17 of the CY 2007 OPPS proposed rule (71 FR 49567).

Comment: A number of commenters requested that CMS not finalize our proposed APC assignments for CPT codes 78492, 78459, and 78491. The commenters stated that it is inappropriate to assign multiple scan procedures to the same APC with single scan procedures as we proposed, because CPT code 78492 requires more hospital resources than do CPT codes 78459 and 78491. The commenters stated that multiple scans require significantly greater hospital resources due to much longer scan times, and believed that our median cost data were seriously flawed.

The commenters objected to the proposal to assign the multiple scan procedures to the same APC as the single scans because they believed the APC assignment creates a 2 times violation for APC 0306; the proposed payment for the multiple scan procedures decreases by 71 percent between CYs 2006 and 2007; if payment is allowed to decrease to the level proposed by CMS, beneficiary access to these important diagnostic procedures (CPT code 78492) will be seriously restricted; the Medicare program will have to spend more for diagnostic procedures such as cardiac catheterizations if hospitals cannot afford to offer the multiple scan myocardial PET procedures; and CMS does assign other cardiac nuclear medicine studies to separate APCs based on whether they are single or multiple.

The commenters recommended that CMS retain the multiple scan procedures in a separate APC as in CY 2006, and that the payment rate decrease be dampened to mitigate the potential for underpayment, as we have in the past for device-dependent and blood product APCs. One commenter suggested that CMS dampen payment for the multiple scans APC by 15 percent each year for the next 2 to 3 years to moderate the large payment decrease for the multiple myocardial PET scans.

Response: We understand the commenters' objections to the median cost for the multiple myocardial PET scans, but see no reason to modify our proposal to assign them to the same APC with the single scans. We do not believe that our data are erroneous. Myocardial PET scans are not new procedures and the data across years, except for the CY 2004 claims data, have been relatively consistent with regard to median costs, while the frequency of multiple scans has been growing consistently. As described above, we explored many aspects of the CY 2005 claims data in an attempt to explain the decreased costs reported for the multiple scans and to assure ourselves and the public that the data were reliable. Our additional investigations included analyses of claims to determine whether they were submitted by only a few hospitals and whether any of the hospitals accounted for an unusually high number of the multiple scan claims or for unusually low costs. We also examined the claims in an attempt to detect whether there were differences in billing practices for the CPT code compared to the predecessor G-codes for multiple myocardial PET scans. There was no indication that the data are erroneous in any regard. Claims were submitted by at least 25 hospitals (compared to 17 in the CY 2004 claims data), and no hospital was responsible for a disproportionate number of claims (in contrast to what was found in the CY 2004 claims) or for unusually low costs. No systematic hospital coding irregularities were discovered. Further, the number of single claims for the multiple scan procedures increased from 872 in the proposed rule data to 983 in the final rule data and the median cost remained stable, increasing by only $5.00, still lower than the median cost for single scans.

Our data do not support a resource differential that warrants assignment of the multiple myocardial scan procedures to an APC separate from the single scans. Single and multiple scan Start Printed Page 68041procedures are closely related from a clinical perspective, and their hospital resources required, as reflected in our claims data, appear comparable in terms of cost. The 2 times violation for CY 2007 in APC 0307 results from the inclusion of limited data from one G-code for multiple scan procedures that was reported for the first 3 months of CY 2005. The median cost for that G-code is $1,840, based on 129 single claims. However, the code was deleted in CY 2005, and the median cost for the CPT code that replaced it is only $665, based on 983 single claims. We utilized the data from the predecessor G-code in developing the median cost for APC 0307 (where it would be likely to affect the APC median cost by raising it). The fact that data from a deleted code are responsible for the violation leads us to conclude that the violation is not significant. Therefore, based on clinical and resource homogeneity, we are excepting APC 0307 from the 2 times rule for CY 2007.

By assigning the multiple and single scans to the same clinical APC for myocardial PET scans, we are maintaining the clinical and resource use homogeneity in APC 0307, where the APC payment will be slightly higher for the multiple scans than it would have been if we retained the multiple scans in a separate APC.

Similarly, we do not believe that there is a basis for dampening the payment decrease for a separate multiple myocardial PET scan APC. Although we have adjusted payment amounts for device-dependent and blood product APCs in the past, as noted by the commenters, we generally have done so to moderate the effects on payment resulting from inaccurate claims data that failed to fully capture the costs associated with the procedures in ways that we could partially identify. In some of these situations, we had very few single claims, contributing to the problem of unstable payment rates, but myocardial PET scans have significant numbers of single claims. We have examined the claims data thoroughly and found nothing to indicate inaccuracy for myocardial PET scans. To the contrary, with the exception of the CY 2004 claims data, we found that costs from the CY 2005 claims are relatively consistent with costs calculated from claims for myocardial PET scans provided in years before CY 2004. We believe that our CY 2006 APC assignments for multiple and single myocardial PET scans to separate APCs were based on data that were unduly affected by one hospital's unusually high charges for multiple scans.

Without evidence that the claims data for CPT codes 78459, 78491, and 78492 are too flawed to use as a basis for setting weights, we believe it is prudent to establish the CY 2007 payment rate for APC 0307 using the standard OPPS methodology for developing payment rates.

After carefully considering the public comments received, we are finalizing the APC assignments for the myocardial PET procedures as shown in Table 12 below without modification.

Table 12.—CY 2007 APC Assignment for Myocardial PET

HCPCS codeShort descriptorCY 2007 SICY 2007 APCCY 2007 median costCY 2007 Final APC 307 median cost
78459Heart muscle imaging (PET)S0307$784.42$726.98
78491Heart image (pet), singleS03071,014.61726.98
78492Heart image (pet), multipleS0307665.42726.98

b. Complex Interstitial Radiation Source Application (APC 0651)

APC 0651 (Complex Interstitial Radiation Source Application) contains only one code, CPT code 77778 (Complex interstitial application of brachytherapy sources). The coding, APC assignment, median cost, and resulting payment rate for CPT code 77778 have not been stable since the inception of the OPPS, and that instability has been a source of concern to hospitals that furnish the service and to specialty societies. The vast majority of claims for interstitial brachytherapy are for the treatment of patients with a diagnosis of prostate cancer. The historical coding, APC assignments, and payment rates for CPT code 77778 and the related service CPT code 55859 (Transperitoneal placement of needles or catheters into the prostate for application of brachytherapy sources) were displayed in Table 14 of the CY 2007 OPPS proposed rule (71 FR 49564), and are reproduced below in Table 13.

Start Printed Page 68042

We have frequently been informed by the public that the instability in our payment rates for APC 0651 creates difficulty in planning and budgeting for hospitals. Moreover, we have been informed that, in this case, reliance on single procedure claims results in use of only incorrectly coded claims for prostate brachytherapy because, for application to the prostate, which is estimated to be 85 percent of all occurrences of CPT code 77778, a correctly coded claim is a multiple procedure claim. Specifically, we have been advised that a correctly coded claim for prostate brachytherapy should include, for the same date of service, both CPT codes 55859 and 77778, brachytherapy sources reported with C-codes, and typically separately coded imaging and radiation therapy planning services. We have been further advised that, in the cases of complex interstitial brachytherapy where sources are placed in sites other than the prostate, the charges for both placing the needles or catheters and for applying the sources may be reported by CPT code 77778 alone because there are no other specific CPT codes for placement of needles or catheters in those sites. In other cases, the placement of needles or catheters may be reported with not otherwise classified codes specific to the treated body area.

At the March 2006 APC Panel meeting, presenters urged the Panel to recommend that CMS use only single procedure claims that contained charges for brachytherapy sources on the same claim with CPT code 77778 to set the median cost for APC 0651. Presenters also urged that CMS adopt a process for using multiple procedure claims to set the median for APC 0651 that would sum the costs on multiple procedure claims containing CPT codes 77778 and 55859 (and no other separately payable services not on the bypass list) and, excluding the costs of sources, split the resulting aggregate median cost on the multiple procedure claim according to a preestablished attribution ratio between CPT codes 77778 and 55859. The presenters also urged CMS to provide hospitals with education on correct coding of brachytherapy services and devices of brachytherapy required to perform brachytherapy procedures. They indicated that any claim for a brachytherapy service that did not also report a brachytherapy source should be considered to be incorrectly coded and thus not reflective of the hospital's resources required for the interstitial source application procedure. The presenters believed that these claims should be excluded from use in establishing the median cost for APC 0651. They believed that hospitals that reported the brachytherapy sources on their claims were more likely to report complete charges for the associated brachytherapy procedure than hospitals that did not report the separately payable brachytherapy sources.

The APC Panel recommended that CMS reevaluate the proposed payment for brachytherapy services in APC 0651 for CY 2007. The APC Panel also recommended that CMS formally work with the Coalition for the Advancement of Brachytherapy, the American Brachytherapy Society, and the American Society for Therapeutic Radiology and Oncology to evaluate the methodology for setting brachytherapy service payment rates in APC 0651.

In response to the APC Panel recommendations, we explicitly analyzed the standard OPPS methodology that we used in determining our CY 2007 proposed payment rate for APC 0651 in the context of alternative multiple bill methodologies.

The organizations that the APC Panel asked us to work with have frequently brought their concerns to our attention through the rulemaking process and otherwise. As stated in the CY 2007 OPPS proposed rule, we will consider the input of any individual or organization to the extent allowed by Federal law, including the Administrative Procedure Act (APA) Start Printed Page 68043and the Federal Advisory Committee Act (FACA) (71 FR 49564).

We establish the OPPS rates through regulations. We are required to consider the timely comments of interested organizations, establish the payment policies for the forthcoming year, and respond to the timely comments of all public commenters in the final rule in which we establish the payments for the forthcoming year.

For the CY 2007 OPPS proposed rule, we developed a median cost for APC 0651 using single procedure claims and the general OPPS methodology, but we also looked at multiple procedure claims that contained the most common combinations of codes used with APC 0651. In the proposed rule, our single procedure claims process using CY 2005 data resulted in using 1,123 claims to calculate a proposed median cost of $1,028.93 for APC 0651. We added CPT code 76965, a CPT code for ultrasound guidance that commonly appeared on claims for complex interstitial brachytherapy, to the bypass list for CY 2007 after close clinical review because we believed that it would typically have little associated packaging. We believed that this change, along with maintenance of CPT code 77290 for complex therapeutic radiology simulation-aided field setting on the bypass list, was responsible for the growth in single procedure claims from the 381 single bills upon which the final APC 0651 median cost was calculated for CY 2006. However, only 6 of these 1,123 single and “pseudo” single claims data used in calculating the proposed median cost also included brachytherapy sources used in complex interstitial brachytherapy source application, and the median cost for these 6 claims at $600.68 was significantly less than the median cost for all single claims. It was unclear why so many of these claims did not contain brachytherapy sources, which were separately paid at cost in CY 2005. Because we proposed to pay separately for brachytherapy sources again for CY 2007, we saw no reason to believe that these few claims for brachytherapy services that included sources, which also did not report CPT code 55859 for placement of needles or catheters into the prostate, were more correctly coded than those claims that did not separately report brachytherapy sources. We believed it was possible that hospitals billing CPT code 77778 and not the associated brachytherapy sources may have bundled their charges for the brachytherapy sources into their charge for CPT code 77778.

We also identified multiple procedure claims that contained both CPT codes 55859 and 77778 and also included any one or more of the following procedure codes, which have repeatedly appeared as common procedures that are reported on the same claim with CPT codes 55859 and 77778: 76000, 76965, or 77290. We then calculated median costs for interstitial prostate brachytherapy in two different ways: (1) Bypassing the line item charges for these three ancillary codes; and (2) packaging the costs of these three ancillary codes. We applied this methodology both (1) to all claims that met these criteria with and without sources; and (2) to claims that met the criteria and also separately reported brachytherapy sources that would be expected to be reported with CPT code 77778. See Tables 15 and 16 published in the CY 2007 OPPS proposed rule (71 FR 49565) and shown below as Table 14-A and Table 14-B for the results of this investigation.

In the proposed rule, we found 10,571 multiple procedure claims with CPT codes 55859 and 77778 reported on the claim, including those both with and without separately reported sources. We found that 7,181 of the 10,571 claims in the proposed rule's data contained any combination of the three ancillary codes (76000, 76965, or 77290). Table 14-A shows the results of bypassing and packaging the line-item costs of the three ancillary procedures based on the data used to construct the proposed rule.

Table 14-A.—Multiple Procedure Claims Including CPT Codes 55859 and 77778 Proposed Rule Data

FrequencyMinimum costMaximum costMean costMedian cost
Ancillary Codes Packaged7180 (1 lost to trimming)$828.46$11,202.81$3,326.50$3,062.99
Ancillary Codes Bypassed7181811.9511,203.813,300.163,030.01

We found 9,791 multiple procedure claims in the proposed rule's data with CPT codes 55859 and 77778 reported on the claim that also included brachytherapy sources that would be used with CPT code 77778. We found that 6,748 of the 9,791 claims contained any combination of the three ancillary codes. Table 14-B shows the results of bypassing and packaging the line-item costs of the three ancillary procedures, using the proposed rule's data.

Table 14-B.—Multiple Procedure Claims Including CPT codes 55859 and 77778 and One or More Brachytherapy Sources—Proposed Rule Data

FrequencyMinimum costMaximum costMean costMedian cost
Ancillary Codes Packaged6,748$890.56$10,224.17$3,240.13$3,026.62
Ancillary Codes Bypassed6,748$912.81$10,307.37$3,215.75$2,992.60

We found that the claims containing CPT codes 55859 and 77778 and any combination of the three identified ancillary codes had mean and median costs that were very close to one another, regardless of whether the hospital billed separately for the brachytherapy sources on the claim with the procedure codes. Moreover, most of the multiple procedure claims we identified contained sources. This led us to conclude that the presence of sources on the claim did not make a significant difference in the median cost of the combined service.

Moreover, when we calculated the total median cost from single bills for the APCs for the two major procedures codes from the proposed rule's data without regard to the separate payments that would be made for CPT codes 76000, 76965, and 77290, the sum of the CY 2007 proposed medians for APC Start Printed Page 680440651 and APC 0163 was $3,197.07, which was greater than the combination medians, even when the three ancillary services were packaged into the combination median. Under our proposed policies for CY 2007, hospitals would also be paid separately for brachytherapy sources, guidance services, and radiation therapy planning services that may be provided in support of services reported with CPT codes 55859 and 77778.

Therefore, as indicated in the CY 2007 OPPS proposed rule (71 FR 49565), we believed that the summed median cost for APC 0651 and APC 0163 results in an appropriate level of full payment for the dominant type of service provided under APC 0651, interstitial prostate brachytherapy. We proposed to use the median cost of $1,028.93, as derived from all single bills for APC 0651 according to our standard OPPS methodology, to establish the median for that APC.

We recognized that prostate brachytherapy was not the sole use of CPT code 77778, although it was the predominant use. Costs attributable to the placement of needles and catheters and to the interstitial application of brachytherapy sources to sites other than the prostate may also be reported on claims whose data map to APC 0651. As we noted in the proposed rule, this clinically driven variability in the claims data was difficult to assess without adding additional levels of complexity to the issue by considering diagnoses in establishing payments rates. However, recognizing that a prospective payment system is a system based on averages and, to the extent that claims for all types of complex interstitial brachytherapy source application were included in the body of claims used to set the median cost for APC 0651, we believed that the payment for these services as proposed for CY 2007 was appropriate.

We received several public comments concerning our proposal. A summary of the comments and our responses follow:

Comment: The commenters generally supported the proposed median cost for APC 0651. One commenter encouraged CMS to consider calculating a packaged combination median cost for both CPT codes 55859 and 77778 and splitting the cost between the two codes, should the median cost for APC 0651 drop by a significant percent in future years as it has sometimes done in the past.

Response: The median cost for APC 0651 calculated using CY 2005 claims data as updated for this final rule with comment period is $1,029.47, virtually the same as the proposed rule median cost of $1,028.93. Together with the median cost for APC 0163 of $2,134.32, and separate payment for each source applied (section VII. of this preamble), we believe that the OPPS will make appropriate payment for brachytherapy services in CY 2007.

After carefully considering the public comments received, we are finalizing our proposal to develop a median cost for APC 0651 using single procedure claims and the general OPPS methodology as discussed above without modification.

c. Proton Beam Therapy (APCs 0664 and 0667)

For CY 2007, we proposed to pay for the following four CPT codes that describe proton beam therapy: 77520 (Proton treatment delivery; simple, without compensation), 77522 (Proton treatment delivery; simple, with compensation), 77523 (Proton treatment delivery; intermediate), and 77525 (Proton treatment delivery; complex). We proposed to assign the simple proton beam therapy procedures to APC 0664 (Level I Proton Beam Radiation Therapy), with a proposed median cost of $1,141, and the intermediate and complex proton beam therapy procedures to APC 0667 (Level II Proton Beam Radiation Therapy), with a proposed median cost of $1,365. These proposed assignments were unchanged from CY 2006. The proposed payment rates for proton beam therapy were based on CY 2005 claims data and showed an increase of about 20 percent over the CY 2006 payment rates.

Comment: Several commenters supported our CY 2007 proposed APC assignments and payment rates for proton beam therapy. The commenters also supported our proposing APC 0664 as an exception to the 2 times rule for CY 2007. They were generally concerned about the payment for the same services furnished in freestanding proton therapy centers located in several States because the OPPS payment rates were very different from the carrier-priced payments for these services. The commenters requested that CMS establish consistent payments for these services under the OPPS and the MPFS because the significant capital costs required to provide proton beam therapy treatments do not vary across delivery settings.

Response: We appreciate the commenters' support for our CY 2007 OPPS proposed payment rates for proton therapy. We note that the OPPS payment rates for these services have increased significantly over the past several years, although we understand that there are only a small number of active hospital-based centers providing proton therapy. In addition, this is the second year in which we have exempted APC 0664 from its violation of the 2 times rule. We also observe that the payment rates for the two proton therapy APCs are quite close for CY 2007, with only a small differential between Levels I and II of therapy. As such, we will continue to monitor our claims data for proton beam therapy in the future to assess the appropriateness of the current APC structure. We are generally concerned about APCs that chronically violate the 2 times rule, especially when those APCs contain few services and we have no specific data concerns regarding the services assigned to them.

With respect to the commenters' request regarding consistent payment for proton therapy under the MPFS and the OPPS, we note the MPFS and the OPPS are completely separate payment systems, whose rates are established based on different methodologies.

After careful consideration of the public comments received, we are finalizing without modification our CY 2007 proposal to provide payment for proton beam therapy through APCs 0664 and 0667, with their payment rates based on the final APC median costs of $1,154 and $1,381, respectively.

d. Urinary Bladder Residual Study (APC 0340)

At its February 2005 meeting, the APC Panel recommended that we move CPT code 78730 (Urinary bladder residual study) from APC 0340 (Minor Ancillary Procedures) to APC 0404 (Level I Renal and Genitourinary Studies) for CY 2006, because the Panel believed that the CY 2003 data for CPT code 78730 may have been derived from incorrectly coded hospital claims. Based on reasons discussed in detail in the CY 2006 OPPS final rule with comment period (70 FR 68602), we maintained the assignment of CPT code 78730 in APC 0340 for CY 2006. For CY 2007, we proposed assignment of CPT code 78370 to APC 0340 once again.

Comment: Several commenters requested that CMS move CPT code 78730 from APC 0340 to APC 0399 (Nuclear Medicine Add-on Imaging). Some commenters indicated that in CY 2005 they disagreed with our APC assignment of APC 0340 for CPT code 78730. One commenter added that the data for CPT code 78730 may have been derived from incorrectly coded hospital claims. The commenters indicated that the CPT Editorial Panel would be revising the service's code descriptor for CY 2007 to more specifically indicate the performance of a nuclear medicine procedure. Start Printed Page 68045

Response: In the November 15, 2004 final rule with comment period (69 FR 65705), we stated that CPT code 78730 was originally created and valued for the MPFS as a procedure requiring the services of a nuclear medicine technician, but that the use of the code subsequently had changed to be used primarily by urologists rather than by nuclear medicine physicians. While we reassigned CPT code 78730 to APC 0340 for CY 2005 based on robust CY 2003 claims data, we solicited other physician specialties to submit resource data for us to review in the context of our hospital claims data so that we could reexamine the appropriate APC placement of CPT code 78730 for CY 2006. While we acknowledge the commenters' repeated concern that the median cost for CPT code 78730 may reflect miscoded claims, commenters again provided no supporting evidence for either CY 2006 or CY 2007 of what they believe to be the true resource costs associated with CPT code 78730. In fact, a relatively stable number of single procedure claims has generated a consistent median cost for CPT code 78730 over the past 5 years (that is, ranging from $39 based on the CY 2001 claims data to $42 based on the CY 2005 claims data) and supports our assignment of CPT code 78730 to APC 0340 with an APC median cost of $37, as opposed to APC 0399 with an APC median cost of $92. We are aware that the code descriptor and parenthetical language in the CPT manual for CPT code 78730 indicating other CPT codes to be reported for certain bladder studies will be modified for CY 2007. However, we do not know if these additional instructions will lead to differences in hospital reporting that result in a significant change in the procedure's cost. Therefore, we are maintaining CPT code 78730 in APC 0340 for CY 2007.

After carefully considering the public comments received, we are finalizing our proposal to assign CPT code 78730 to APC 0340 for CY 2007, with a median cost of $37.29.

e. Hyperthermia Treatment (APC 0314)

We did not propose any APC assignment changes for CY 2007 for the CPT codes used to report hyperthermia treatments. The following five hyperthermia treatment CPT codes are the only codes that we proposed to assign to APC 0314 (Hyperthermic Therapies) for CY 2007: 77600 (Hyperthermia, externally generated; superficial); 77605 (Hyperthermia, externally generated; deep); 77610 (Hyperthermia, generated by interstitial probe(s); 5 or fewer interstitial applicators); 77615 (Hyperthermia, generated by interstitial probe(s) more than 5 interstitial applicators); and 77620 (Hyperthermia generated by intracavitary probe(s)). The CY 2007 proposed median cost for APC 0314 was $225.96.

Comment: Several commenters reported that the proposed APC 0314 CY 2007 payment rate was 32 percent less than the CY 2006 payment rate of $332.31 and suggested that the decrease was due to the use of inaccurate CMS claims data.

The commenters believed that the flaws in the CMS claims data were due to a few factors: The variation in hospitals' cost allocation methodologies; CMS' use of hospital CCRs derived from those varying hospital allocation practices and which they reported varied dramatically (from 15 to 50 percent) across hospitals that provided hyperthermia therapies; and low utilization among the few hospitals that reported the services. Further, the commenters expressed an additional concern for one of the procedures, CPT code 77605, for which there were no claims in the CY 2005 data that CMS used for the CY 2007 median calculation proposal. The commenters added that in past years, the procedure had been one of the more frequently reported therapies, and they believed that having no cases in the claims data used to calculate the medians for APC 0314 was indicative of inaccurate data and also contributed to the inappropriately low proposed median cost.

The commenters submitted some estimated hospital costs of hyperthermia treatment for five hospitals, and recommended three options that CMS could use to moderate the proposed CY 2007 payment decrease for APC 0314. The three options are as follows: That CMS could use external hospital survey data to establish a payment rate of $1,005 for APC 0314; that CMS could apply an average cost for CPT code 77605 using the medians calculated for CY 2004 through CY 2006 to establish a more appropriate payment amount for CY 2007; or that CMS could maintain the CY 2006 payment rate for CY 2007.

Response: In our analysis, we found that there were 55 claims reported for CPT code 77605 in the CY 2005 data, but that all were excluded from the data because they did not meet the criteria for use in calculating the median costs due to any number of factors. Included among the reasons for removing the claims for CPT 77605 from the CY 2005 data that were used to calculate median costs were that the reporting hospitals' claims were excluded because their CCRs were outside of the allowed range, or the reporting hospital was a CAH or an otherwise excluded hospital (as explained in section II. of this final rule with comment period).

We exclude claims from the data to be used for calculation of median costs every year to ensure that the claims we use are accurate and valid representations of claims for the services. The method for identifying claims that meet the criteria for inclusion in the median cost development process for CY 2007 was performed similarly to the methodology applied for past OPPS updates and should not have had a disproportionate effect on hyperthermia procedures.

As noted by the commenters, median costs for the hyperthermia procedures have been somewhat unstable across the years due to low volume and the small number of facilities reporting the procedures. For CY 2007, the decrease is more pronounced than changes in past years and we appreciate the providers' concerns. We note that these historical changes have served both to increase and decrease payments for the treatments over time. We agree with the commenters' observation about the relative median cost instability for these procedures and the probable reasons for that, but given that we do not observe specific inaccuracies in our claims data that are used in the standard OPPS methodology, it appears these fluctuations are in keeping with the historical charges.

The median costs for the individual procedures assigned to APC 0314 vary from approximately $194 to $431. The median for the APC overall is significantly lower than the highest service-specific median because 195 of the 225 single claims for the APC are for CPT code 77600, which has a median cost of $194. In the past, CPT code 77605 has contributed a significant number of claims to the number of single claims in the APC and has also had a higher median than CPT 77600. Thus, the lack of claims for that procedure may have contributed to the lower APC median for CY 2007, but the median cost calculated for the APC is accurate and reflects costs for those services based upon the CY 2005 claims data that meet our criteria for use in calculating APC medians. We have no reason to doubt the accuracy of those data and, therefore, have no basis for diverging from the established method of calculating the median cost for APC 0314.

For these reasons, we will not accept any of the options recommended to us by the commenters and are finalizing the CY 2007 payment rate for APC 0314 Start Printed Page 68046based on its median cost of $204, calculated using our CY 2005 claims data as proposed.

f. Unlisted Procedure for Clinical Brachytherapy (APC 0312)

For CY 2007, we proposed to move CPT code 77799 (Unlisted procedure, clinical brachytherapy) from APC 0313 (Brachytherapy) to APC 0312 (Radioelement Applications) for the CY 2007 OPPS.

Comment: Several commenters objected to the proposal to reassign CPT code 77799 from APC 0313 to APC 0312 for CY 2007. The commenters stated that APC 0312 is titled “Radioelement Applications,” while APC 0313 is titled “Brachytherapy,” and that it is in keeping with the intent of APC classification to group procedures that are similar in clinical characteristics and resource use. Therefore, the commenters believed that because APC 0313 was the lowest payment level brachytherapy APC, it would be most appropriate to continue to assign CPT code 77799 to APC 0313 with other brachytherapy procedures.

Response: We disagree. CPT code 77799 has no meaningful definition that would enable us to place it accurately in one brachytherapy APC versus another APC based on clinical homogeneity or resource considerations. While the APC title for APC 0312 does not contain the term brachytherapy explicitly, all of the procedures assigned to APC 0312 are from the section of the CPT manual called “Clinical Brachytherapy.” Furthermore, APC 0312, not APC 0313, is the lowest payment level brachytherapy procedure APC. In CY 2005, we finalized the OPPS policy of assigning all unlisted or “not otherwise classified” HCPCS codes to the lowest level APC that is appropriate to the clinical nature of the service (69 FR 65725). Therefore, we believe that our reassignment of CPT code 77799 to APC 0312 is appropriate.

After carefully considering the public comments received, we are finalizing our CY 2007 proposal for the assignment of CPT code 77799 to APC 0312, without modification.

3. Cardiac and Vascular Procedures

a. Electrophysiologic Recording/Mapping (APC 0087)

At its March 2006 meeting, the APC Panel heard testimony from a presenter who asked that the Panel recommend that CPT codes 93609 (Intraventricular and/or intra-atrial mapping of tachycardia, add-on); 93613 (Intracardiac electrophysiologic 3-D mapping); and 93631 (Intra-operative epicardial and endocardial pacing and mapping to localize zone of slow conduction for surgical correction) be removed from APC 0087. The presenter asked the APC Panel to recommend that these codes be placed in APC 0086 (Ablate Heart Dysrhythm Focus) for improved clinical and resource alignment. The presenter indicated that the median costs for these CPT codes were more than two times the median cost of the least costly HCPCS code in APC 0087 and, therefore, constituted a 2 times rule violation. The presenter also indicated that the median cost of APC 0087 had declined in recent years, and argued that the payment rate for APC 0087 was too low to adequately compensate providers for these services.

The APC Panel did not recommend that CMS move these codes from APC 0087 to APC 0086, but instead recommended that CMS maintain the three codes in APC 0087 for CY 2007. The APC Panel noted that, due to the low volume of these and other services assigned to APC 0087, under the CMS' rules there was no 2 times violation in APC 0087. Moreover, the APC Panel found that the services under discussion were cardiac electrophysiologic mapping services like other procedures also assigned to APC 0087, and were, therefore, clinically coherent with other services in APC 0087. The APC Panel did not believe that these three cardiac electrophysiologic mapping procedures were similar clinically or from a resource perspective to the intracardiac catheter ablation procedures residing in APC 0086. We agreed with the APC Panel's assessment and accepted this APC Panel recommendation. Therefore, we proposed that CPT codes 93609, 93613, and 93631 remain assigned to APC 0087 for CY 2007.

We did not receive any public comments concerning our proposal. Therefore, we are adopting our CY 2007 proposal as final without modification.

b. Endovenous Laser Ablation Procedures (APC 0092)

We proposed to reassign CPT codes 36478 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous laser; first vein treated;) and 36479 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous laser; second and subsequent veins treated in a single extremity, each through separate access sites) from APC 0091 (Level II Vascular Ligation) for CY 2007 to APC 0092 (Level I Vascular Ligation), with a proposed median cost of $1,518.22 for CY 2007.

Comment: A few commenters requested that CMS retain CPT codes 36478 and 36479 in APC 0091 for CY 2007 instead of assigning them to APC 0092, as we proposed. The commenters believed that the percutaneous laser procedures should be assigned to the same APC as CPT codes 36475 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated); and 36476 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; second and subsequent veins treated in a single extremity, each through separate access sites), because the hospital costs for both types of procedures are very similar. The proposed APC assignment for CPT codes 36475 and 36476 was to APC 0091.

Response: In our review of APCs for the CY 2007 proposed rule, we found that the procedures assigned to APCs 0091 and 0092 were appropriate clinically, but that the median costs within both of the APCs had become heterogeneous so there was not significant differentiation between the medians for the two levels of vascular APCs. In addition, CPT codes 36475 through 36479 were new in CY 2005 and, as such, their median costs were available to us for the first time in our development of the CY 2007 proposed rule.

In order to remedy the heterogeneity within APCs 0091 and 0092, we reconfigured them to achieve greater differentiation between the median costs of the two APCs and to improve internal homogeneity. In that reconfiguration, CPT codes 36478 and 36479 were assigned to APC 0092, with other procedures with similar resource requirements. The median costs for CPT codes 36478 and 36479 are $1,521 and $1,241, respectively, and the median cost for APC 0092 is $1,520. There are more than 800 single claims for CPT code 36478, and we are confident that the data reflect hospital costs for the procedure. We believe that these procedures fit appropriately into the APC 0092.

In contrast, CPT codes 36475 and 36476 were assigned to APC 0091, which has a median cost of $2,122. The median costs for those procedures are $2,295 and $3,017, respectively, and there are more than 900 single claims for CPT code 36475. Although the endovenous ablation procedures described by CPT codes 34675 through 36479 are clinically related, we do not believe that they belong in the same Start Printed Page 68047APC. In this case, there exist separate APCs into which each procedure type is appropriately assigned to reflect more similar usage.

The reconfiguration resulted in improved differentiation between the two APCs. For CY 2006, the difference between the APC median costs was only about $140. For CY 2007, that difference is about $600, and the internal homogeneity in each APC is improved.

For these reasons we are finalizing our proposal to assign CPT codes 36478 and 36479 to APC 0092 for CY 2007.

c. Repair/Repositioning of Defibrillator Leads (APC 0106)

For CY 2007, we proposed to assign CPT code 33218 (Repair of single transvenous electrode for a single chamber, permanent pacemaker or single chamber pacing cardioverter-defibrillator), and CPT code 33220 (Repair of two transvenous electrodes for a dual chamber permanent pacemaker or dual chamber pacing cardioverter-defibrillator) to APC 0106 (Insertion/Replacement/Repair of Pacemaker and/or Electrodes), with a proposed median cost of $2,754.86. These procedures were both assigned to APC 0106 for CY 2006.

Comment: Several commenters asked CMS to reassign CPT codes 33218 and 33220 from APC 0106 to APC 0105 (Revision/Removal of Pacemakers, AICD, or Vascular Devices) because these two codes do not require a device like other codes in APC 0106 and their median costs are closer to the proposed median cost of APC 0105 of $1,449.44.

Response: We agree and have moved CPT codes 33218 and 33220 out of APC 0106 and into APC 0105 for CY 2007. The final rule median cost for APC 0106 is $3,596.86.

After carefully considering the public comments received, we are finalizing our CY 2007 proposal with modification to reassign CPT codes 33218 and 33220 from APC 0106 to APC 0105. We also are modifying the titles of these APCs to reflect their new composition. APC 0106 is retitled “Insertion/Replacement of Pacemaker Leads and/or Electrodes.” APC 0105 is retitled “Repair/Revision/Removal of Pacemakers, AICDs, or Vascular Devices.” The final median cost of APC 0106 is $3,596.87, and the final median cost of APC 0105 is $1,565.27.

d. Thrombectomy Procedures (APCs 0103 and 0653)

For CY 2006, new CPT codes 37184 (Primary percutaneous transluminal mechanical thrombectomy, noncoronary, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); initial vessel); 37187 (Percutaneous transluminal mechanical thrombectomy, vein(s), including intraprocedural pharmacological thrombolytic injection(s) and fluoroscopic guidance); and 37188 (Percutaneous transluminal mechanical thrombectomy, vein(s), including intraprocedural pharmacological thrombolytic injection(s) and fluoroscopic guidance, repeat treatment on subsequent day during course of thrombolytic therapy) were provided interim final assignments to APC 0653 (Vascular Reconstruction/Fistula Repair with Device). New CPT codes 37185 (Primary percutaneous transluminal mechanical thrombectomy, noncoronary, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); second and all subsequent vessel(s) within the same vascular family) and 37186 (Secondary percutaneous transluminal thrombectomy (e.g., nonprimary mechanical, snare basket, suction technique), noncoronary, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injections, provided in conjunction with another percutaneous intervention other than primary mechanical thrombectomy) were provided interim final assignments to APC 0103 (Miscellaneous Vascular Procedures). The proposed assignments of these codes for CY 2007 were unchanged.

Comment: One commenter who addressed our CY 2006 APC assignments for CPT codes 37184, 37187, and 37188 believed that all of the new codes should have been assigned to APC 0088 (Thrombectomy). The commenter stated that the procedures reported by the new CPT codes were very similar to the procedures reported by CPT code 92973 (Percutaneous transluminal coronary thrombectomy), that was assigned to APC 0088 because they required the use of a costly mechanical thrombectomy catheter. The commenter stated that the procedures coded with CPT codes 37184 through 37188 also required the use of costly catheters and were clinically more similar to the other procedures assigned to APC 0088 than to those assigned to either APC 0103 or APC 0653.

Response: Although we will not have data for these procedures until next year, based on the information in the comment and our further review, we agree with the commenter that a more appropriate assignment for the procedures is APC 0088 for CY 2007. We believe the reassignments provide more accurate payment for these thrombectomy procedures.

After careful consideration of the public comment received, we are finalizing our proposal for the APC assignments of CPT codes 37184, 37185, 37186, 37187, and 37188 with modification. All five procedures are assigned to APC 0088 for CY 2007.

4. Gastrointestinal and Genitourinary Procedures

a. Insertion of Mesh or Other Prosthesis (APC 0195)

During the March 2006 APC Panel meeting, a presenter requested that we reassign CPT code 57267 (Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach) to a more clinically and resource-appropriate APC than its CY 2006 assignment to APC 0154 (Hernia/Hydrocele Procedures). The presenter expressed concern that the procedure was currently assigned to an APC with a “T” status indicator and stated that payment would be more accurate if it were assigned to an APC that has an “S” status indicator. The mesh insertion procedure is a CPT add-on code and is, by definition, performed at the same time as certain other procedures and will, therefore, be discounted every time it is performed. The presenter objected to our assignment of CPT code 57267 to an APC that was subject to the multiple procedure discount because it was always a secondary procedure, and the discounted payment amount was not adequate to pay even for the cost of the implantable mesh. The presenter also believed that its assignment to an APC where hernia and hydrocele procedures were also assigned was clinically inappropriate.

The APC Panel recommended that CMS reassign CPT code 57267 to a more clinically and resource-appropriate APC.

As stated in the CY 2007 OPPS proposed rule, in the CY 2005 claims data, the median cost for CPT code 57267 was $529.14, the lowest by far for procedures in APC 0154, which had a proposed APC median cost of $1,821 for CY 2007 (71 FR 49562). However, the proposed median cost of CPT code 57267 was based on only 6 single claims of the total 1,038 claims submitted for the service. Because the procedure always was performed in addition to other related procedures, we expected that claims for this service would be multiple claims. Therefore, we were not confident that the procedure's median Start Printed Page 68048cost based upon the six single claims was accurate.

Therefore, at the time of the proposed rule, in order to obtain more information about the cost of the procedure, we performed additional analyses of CY 2005 claims data in an attempt to specifically explore the cost of the mesh implant packaged into the payment for CPT code 57267. We believe that a significant portion of the procedural cost should be related to the cost of the mesh, based on information presented at the March 2006 APC Panel meeting. We looked at all claims that included charges for the HCPCS code for implantable mesh (C1781) and either CPT code 57267 or 49568 (Implantation of mesh or other prosthesis for incisional or ventral hernia repair). We examined the bills for CPT code 49568 in addition to those for CPT code 57267 because it was a high volume procedure that also used implantable mesh, and we expected that the extra volume would improve our chances of identifying meaningful charge data.

We found 210 claims with charges reported for both CPT code 57267 and HCPCS code C1781 on the same day and 6,345 claims with reported charges for both CPT code 49568 and HCPCS code C1781 on the same day. Costs developed from these two claims subsets included the cost of the implanted mesh device that was used in performing the procedure. Table 13 published in the CY 2007 OPPS proposed rule displayed the median costs from those claims (71 FR 49562). The costs shown in the column titled “Line-item Median Cost” of Table 13 were those we obtained by looking at all CY 2005 OPPS claims upon which charges for both the procedure code (either CPT code 57267 or 49568) and the code for the implantable mesh (HCPCS code C1781) were reported. The costs shown in the column titled “Single Claims Median Cost” were the median costs calculated using only single procedure claims for the specific procedure that also included the C-code for the mesh.

Our additional data analysis supported the APC Panel presenter's assertion that the cost of the mesh was greater than 50 percent of the total cost of CPT code 57267, but it also indicated that the mesh cost was far less than 50 percent of the payment amount for APC 0154. In CY 2006, the payment rate for APC 0154 was $1,704.59, and the payment when the multiple procedure discount was taken was $852.30, which was much greater than both the line-item median cost of the mesh and the median single claims cost of CPT code 57267 (which explicitly included the implantable mesh) reflected in our claims data.

We agreed with the APC Panel that the procedure should be assigned to a more clinically appropriate APC, and therefore, we proposed to accept its recommendation and reassign CPT code 57267 to APC 0195 (Level IX Female Reproductive Procedures), with status indicator “T” for CY 2007. The proposed median cost of APC 0195 was $1,777 for CY 2007, very comparable to the CY 2006 median cost of APC 0154, where CPT code 57267 was assigned for CY 2006. The median cost for the procedure remained very low in comparison with other procedures assigned to APC 0195; therefore, we believe that payment for the service when the multiple procedure reduction was applied would be appropriate. While not affecting the procedure's payment significantly, this reassignment improved the clinical homogeneity of APCs 0154 and 0195.

Comment: The commenters generally believed that CPT code 57267 should be assigned to APC 0202 (Level X Female Reproductive Procedures), which is a device-dependent APC and for which the proposed CY 2007 median cost is $2,534.46. They stated that the analyses that CMS performed for the proposed rule to identify costs for the procedure described by CPT code 57267 when billed with the HCPCS code C1781 for the mesh implant were incorrect because the mesh devices that are used in pelvic floor repair are best described by HCPCS codes C1762 (Connective tissue, human (includes fascia lata)) and C1763 (Connective tissue, non-human (includes synthetic)). One commenter provided data showing the costs of four procedures, including CPT codes 57240 (Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele) and 57250 (Posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), when performed with and without the graft insertion procedure, CPT code 57267. Their data indicated that the median cost for CPT code 57267, including the device (C1762 or C1763), ranged from $946 to $1,465, and that, on average, the cost was $1,254.

Response: In response to the comments, we performed additional analyses of claims for CPT code 57267 that included the two types of mesh/connective tissues devices coded with HCPCS codes C1762 and C1763, as well as those with device code C1781 that we presented in the proposed rule. We analyzed all single and “pseudo” single claims and multiple claims for CPT code 57267 reported with one of the 3 device codes (C1762, C1763, and C1781) and examined the line-item cost for each of the three devices, based upon our belief that the cost of the add-on repair procedure was principally due to the device cost. The results of our study showed that the median line-item costs for device codes C1762 and C1763 on claims for the pelvic floor repair procedure were $810.72 and $503.71, respectively, compared to $352.20 for device code C1781.

Although the commenters stated that the graft insertion procedure to repair the pelvic floor was performed using only the connective tissue products coded by device codes C1762 and C1763, there is no guidance with regard to use of the CPT code 57267 that specifically restricts the type of device that may be reported with that code. In the list of device category codes and their definitions posted on the CMS Web site, we indicate that device code C1781 is defined as, “A mesh implant or synthetic patch composed of absorbable or non-absorbable material that is used to repair hernias, support weakened or attenuated tissue, cover tissue defects, etc.” We also note in the definition that other device codes should be used for reporting connective tissue when used to treat urinary incontinence. There are far more CY 2005 claims for CPT code 57267 with device code C1781 than with either of the device codes presented by the commenters. Therefore, the CY 2005 claims data for the procedure are more reflective of the use of the mesh reported with device code C1718 than of the mesh the commenters believed was most often used. Table 15 displays the numbers of claims and the median costs found in our analyses.

We continue to believe that assignment of CPT code 57267 to APC 0195 is appropriate and ensures adequate payment for the procedure, even when the multiple procedure discount is taken. Based on the typical cost of any one of the mesh/connective tissue devices that are used in the service, 50 percent of the payment for APC 0195, based on its CY 2007 median cost of $1742.20, should be appropriate. Assignment to APC 0202, with a median cost of $2,534.46, would result in overpayment for the procedures. Start Printed Page 68049

Table 15.—Median Costs of HCPCS Codes C1762, C1763 and C1781 and 57267

HCPCS codeShort descriptorCY 2005 frequency of total claimsCY 2005 line-item median cost
C1762 (billed with 57267)Conn tiss, human (inc fascia)22$810.72
C1763 (billed with 57267)Conn tissue, non-human55503.71
C1781 (billed with 49568)Mesh (implantable)175352.20

After carefully considering the public comments received, we are finalizing our proposal to reassign CPT code 57267 to APC 0195 without modification.

b. Percutaneous Renal Cryoablation (APC 0423)

During the March 2006 APC Panel meeting, a presenter requested that we reassign CPT code 0135T (Ablation renal tumor(s), unilateral, percutaneous, cryotherapy) from APC 0163 (Level IV Cystourethroscopy and other Genitourinary Procedures) to APC 0423 (Level II Percutaneous Abdominal and Biliary Procedures). The presenter provided information about the costs of performing these procedures and compared the resource requirements for the procedures to those for CPT code 47382 (Ablation, one or more liver tumor(s), percutaneous, radiofrequency), which is currently assigned to APC 0423. The presenter proposed reassignment of CPT code 0135T to APC 0423 because that was where CPT code 47382 was assigned, and stated that the costs of the two procedures were very similar.

Based on the information presented, the APC Panel recommended that we reassign CPT code 0135T from APC 0163 to APC 0423 for CY 2007.

CPT code 0135T is new for CY 2006 and, therefore, we had no claims data upon which to base our APC assignment decision. The procedure currently has an interim assignment to APC 0163, with a CY 2006 payment amount of $1,999.35.

In the CY 2007 OPPS proposed rule, we proposed to accept the APC Panel's recommendation to reassign CPT code 0135T to APC 0423 for CY 2007. We believed that assignment of CPT code 0135T to APC 0423 was clinically appropriate, and the CY 2007 proposed median cost of APC 0423 of $2,410.33 was reasonably close to our expectations regarding the resource requirements for the renal cryoablation procedure. The APC Panel did not discuss this procedure again at its August 2006 meeting, nor were there any public presentations on this issue at that meeting.

Comment: Several commenters approved of the proposed reassignment of CPT code 0135T from APC 0163 to APC 0423 for CY 2007 because this move placed the percutaneous cryoablation procedure with other similar procedures. However, the commenters were concerned that the payment rate for CPT code 0135T was inadequate and did not reflect the total cost incurred by hospitals in providing this service. The commenters also indicated that the payment rate for CPT code 0135T was not based on timely data or accurate hospital claims. The commenters believed that the proposed payment rate would not cover the costs of the expensive cryoablation probes used in performing the procedures. One commenter indicated that the average cost of one probe was about $1,000, and the average procedure used between 2.3 and 2.5 probes. Another commenter submitted copies of invoices showing the costs of the probes. The commenter urged CMS to reevaluate the payment for APC 0423, because an underpayment could result in hospitals not offering this procedure, thereby creating an access barrier for Medicare patients. Several commenters requested that CMS use all available data, including external data, to determine the appropriate payment rate for APC 0423.

Response: We reviewed the data for APC 0423, considered the comments, and examined all available information regarding the procedure described by CPT code 0135T, as well as other procedures that are separately payable under the OPPS and for which we have claims data. In addition, we reviewed the recommendation of the APC Panel from its March 2006 meeting that was based upon the request of a presenter. Based on our evaluation, we believe that we have appropriately assigned CPT code 0135T to APC 0423 for CY 2007 based on clinical and resource homogeneity considerations. Under the standard OPPS methodology, the APC payment rate is established based on CY 2005 claims data for those services for which there are data. One service also assigned to APC 0423 has significant claims volume, and its median costs have been stable over the past several years. The final median cost of APC 0423 upon which the payment rate for CPT code 0135T is based is $2,283.08. We believe that this payment will be sufficient to ensure access to this service for Medicare beneficiaries.

Comment: Several commenters acknowledged that cryoablation and radiofrequency percutaneous ablation procedures for renal tumors were clinically similar; however, there were major resource differences in the required equipment and the technology-specific probes. One commenter indicated that the radiofrequency ablation procedure involves the use of only one probe, while the cryoablation procedure requires, on average, 2.5 probes.

Response: We believe that CPT code 0135T is appropriately assigned to APC 0423 because it is placed with other procedures that share clinical and resource homogeneity. If hospitals use more than one probe in performing the renal cryoablation procedure, we expect hospitals to report this information on the claim and adjust their charges accordingly. Hospitals should report the number of cyroablation probes used to perform CPT code 0135T as the units of HCPCS code C2618 (Probe, cryoablation), which describes these devices, with their charges for the probes. Since CY 2005, we have required hospitals to report device HCPCS codes for all devices used in procedures if there are appropriate HCPCS codes available. In this way, we can be confident that hospitals have included charges on their claims for costly devices used in procedures when they submit claims for those procedures.

Comment: Several commenters indicated that in the CY 2007 OPPS proposed rule we acknowledged the lack of claims data to set the payment rate for the renal cryoablation procedure reported with CPT code 0135T. They believed that CMS should assign CPT code 0135T to a New Technology APC and base its payment on the actual cost of performing the procedure. One commenter reported that the renal cryoablation procedure was a relatively new procedure that had only rarely been performed in the outpatient setting. The commenter also noted that assigning CPT code 0135T to a New Technology Start Printed Page 68050APC would allow CMS time to obtain meaningful outpatient cost information for the procedure, so that CMS could eventually place the procedure in an appropriate clinical APC. The commenter added that prior to January 1, 2006, there was no specific HCPCS code that accurately described the renal cryoablation procedure, and, as a result, the service was reported by those hospitals performing the procedure under the general unlisted CPT code 53899. Because of the use of the unlisted CPT code, the commenter indicated that it would be impossible to identify the historical hospital outpatient claims that were related to percutaneous renal cryotherapy.

Response: While we previously acknowledged the lack of claims data in setting the payment rate for CPT code 0135T, we have commonly assigned a new service or procedure without claims data to a clinical APC that we believed appropriately reflected the cost and clinical features of the procedure. We often have relevant information available to us based on claims data for other services historically paid under the OPPS, as well as data provided to us by the public. In the case of CPT code 0135T specifically, the APC Panel at its March 2006 meeting recommended that we reassign this code from APC 0163 to APC 0423 for CY 2007. Based on this recommendation and our comprehensive review of the procedures assigned to APC 0423, we believe that we have assigned the renal cryoablation procedure to an appropriate clinical APC, specifically APC 0423, which reflects clinical homogeneity and comparable resource costs among the procedures assigned to the APC for CY 2007. We note that we expect to have claims data for CPT code 0135T available for the CY 2008 OPPS update.

After carefully considering all the public comments received, we are reassigning CPT code 0135T to APC 0423, as proposed, without modification. The final APC 0423 median cost is $2,283.08.

c. Ultrasound Ablation of Uterine Fibroids with Magnetic Resonance Guidance (MRgFUS) (APCs 0195 and 0202)

We received many public comments concerning the APC assignments for HCPCS codes 0071T and 0072T.

In the CY 2006 final rule we assigned magnetic resonance guided focused ultrasound ablation of uterine fibroids (MRgFUS) procedures, CPT codes 0071T and 0072T, to APCs 0195 (Level IX Female Reproductive Procedures) and 0202 (Level X Female Reproductive Procedures), respectively, for CY 2006. We made those reassignments in response to public comments to our proposed rule of July 25, 2005, in which we had proposed to assign the procedures to APC 0193 (Level V Female Reproductive Procedures) for CY 2006. These services had been assigned to APC 0193 since their implementation in the OPPS in CY 2005. We proposed no changes to their final CY 2006 assignments for CY 2007.

Comment: Although our assignments of the procedures were to separate, higher paying APCs for CY 2006 than their assignments for CY 2005, commenters on the CY 2007 proposed rule believed that the procedures' assignments still resulted in significant underpayment. The commenters asserted that while MRgFUS treats anatomical sites that are similar to other procedures assigned to APCs 0195 and 0202, the resources utilized differ dramatically. Further, they stated that treatment of uterine fibroids using the MRgFUS procedure is more cost effective for the Medicare program and for beneficiaries because the recovery time is shorter, and beneficiaries would be spared the need for hysterectomies.

The commenters indicated that the most appropriate assignment for the MRgFUS procedures would be APC 0127 (Level IV Stereotactic Radiosurgery) based on their analyses of the procedures' resource use and clinical characteristics. The similarities between the two technologies that were presented by the commenters included their clinical indication to treat non-invasive tumors by using focused ionizing radiation (stereotactic radiosurgery) or acoustic waves (MRgFUS) to destroy the tumor tissue.

Further, the commenters argued that the procedures require similar hospital resources: planning prior to treatment; specialized equipment housed in treatment rooms; continuous monitoring during treatment; and 120 to 300 minutes to perform the treatment.

One commenter sent data that compared the hospital charges for three MRgFUS cases to those for five stereotactic radiosurgery (SRS) procedures. Those data showed charges for CPT code 0071T of $18,215 and for 0072T, $22,122 and $23,463, and for SRS, charges ranging from $21,360 to $28,790. In addition, many of the commenters reported that their hospitals charge between $18,000 and $24,000 for each MRgFUS treatment.

Response: As we stated in the November 10, 2005 final rule, we believe that MRgFUS treatment bears a significant relationship to technologies already in widespread use in hospitals, in particular magnetic resonance imaging (MRI) and ultrasound services. The use of focused ultrasound for thermal tissue ablation has been in development for decades, and the recent application of MRI to focused ultrasound therapy provides monitoring capabilities that may make the therapy more clinically useful. We believe that MRgFUS therapy is a new and integrated application of existing technologies (MRI and ultrasound) and that the technology used in this service fits as well into existing clinical APCs for female reproductive services, as do many other modalities that are currently assigned to those clinical groups. Retaining them in clinical APCs with other female reproductive procedures will enable us both to set accurate payment amounts and to maintain appropriate clinical homogeneity of the APCs.

The similarity of the charges for MRgFUS and SRS as reflected in the examples provided by one commenter does not convince us that the level of hospital resources used to provide MRgFUS is the same as for SRS. APC assignments are made based on consideration of both hospital resources and clinical homogeneity. There are many OPPS claims with similar charges, but where the reported procedures have nothing in common with one another clinically. We do not assign those procedures to the same clinical APC.

In our CY 2005 claims data, there are two claims for CPT code 0071T but none for CPT code 0072T and 3,346 claims for the single SRS service assigned to APC 0127. Those data show the median cost for SRS is $8,461 and the median cost for the two MRgFUS claims is $1,026. We realize the limited nature of the data from which to draw any conclusions about cost, but because treatment of uterine fibroids is most common among women younger than 65 years of age, we do not expect that there ever will be many Medicare claims for those procedures. Nevertheless, we do not see a compelling reason to except MRgFUS from our established policy to rely on our claims as the basis for weight-setting under the OPPS.

Further, and in contrast with SRS, the MRI equipment used to provide the MRgFUS therapy can also be used to perform conventional MRI procedures and does not necessarily represent an additional capital expense for the hospital. Those costs should be allocated accordingly so that amortization will be shared by those other tests. In addition, we remind commenters that the OPPS was originally set up to be budget neutral to the prior system, which under several provisions of the statute, paid Start Printed Page 68051approximately 82 percent of reported hospital outpatient department costs as shown on the cost reports. Therefore, payment rates for individual services are set, in effect, to reflect relative resource use within a payment system that pays, on average, at what was a discount of approximately 18 percent. Because the OPPS is a prospective payment system as well, payment may be more or less than a provider's costs in any specific case. We expect that our payment rates generally will reflect the costs that are associated with providing care to Medicare beneficiaries in cost-efficient settings.

Prior to assigning CPT codes 0071T and 0072T to APCs 0195 and 0202 respectively, we compared the necessary hospital resources for the MRgFUS procedures, including specialized equipment, MRI/procedure room time, personnel, anesthesia and other required resources, to various other procedures for which we have historical hospital claims data. In addition, we took into consideration projected costs for the MRgFUS procedures submitted to us, and other available information regarding the clinical characteristics and costs of those services. We do not believe that there are significant clinical similarities between MRgFUS and the multi-source photon SRS procedure assigned to APC 0127. This SRS procedure is generally performed on intracranial lesions, and requires immobilization of the patient's head in a frame that is screwed into the skull. Several hundred converging beams of gamma radiation are applied to the target lesion, requiring their accurate placement to the fraction of a millimeter. In contrast, during MRgFUS, MRI guidance is utilized to confirm tissue heating, while multiple sonications at various points in the fibroid treatment area are executed until the entire target volume has been treated. Therefore, we do not think these two types of procedures are clinically similar, nor do we believe they require comparable hospital resources based on the considerations described previously that went into our CY 2006 APC assignments for MRgFUS and SRS procedures.

We continue to believe that the assignments of CPT codes 071T and 072T for MRgFUS procedures to APCs 0195 and 0202 respectively for CY 2007 will make appropriate OPPS payments for MRgFUS services, thereby ensuring access for Medicare beneficiaries who need them.

After careful consideration of the public comments received, we are finalizing our proposed CY 2007 APC assignments of CPT codes 071T and 072T, without modification.

d. Laser Vaporization of Prostate (APC 0429)

For CY 2007, we proposed to assign CPT code 52648 (Laser vaporization of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)) to APC 0429 (Level V Cystourethroscopy and other Genitourinary Procedures), with a proposed median cost of $2,651.79. The procedure was assigned to APC 0429 for CY 2006.

Comment: One commenter indicated that the proposed assignment of CPT code 52648 to APC 0429 seemed appropriate but asked CMS to use only claims for CPT code 52648 that also contained HCPCS code C9713 (Noncontact laser vaporization of prostate, including coagulation control of intraoperative and postoperative bleeding) to calculate the median cost for APC 0429. The commenter believed that by using single bills that did not also contain HCPCS code C9713, CMS may have excluded the correctly coded claims.

Response: We agree that assignment of CPT code 52648 to APC 0429 is appropriate, but we disagree that we should require HCPCS code C9713 to be on all claims for CPT code 52648 as either a condition of payment for CPT code 52648 or to calculate the median cost of APC 0429. HCPCS code C9713 was created to describe the service for laser vaporization of the prostate because we did not believe that CPT code 52648, as defined before January 1, 2006, described the same service, and HCPCS code C9713 should not have been included on any claims with CPT code 52648. HCPCS code C9713 was deleted effective December 31, 2005, as a result of the change to the descriptor of CPT code 52648. Hospitals that billed both codes on the same claim in CY 2005 were billing incorrectly, as HCPCS code C9713 did not describe the device used to furnish the service.

After carefully considering the public comment received, we are finalizing our CY 2007 proposal to assign CPT code 52648 to APC 0429 for CY 2007. The CY 2007 final median cost of APC 0429 is $2,633.85.

e. Gastrointestinal Procedures with Stents (APC 0384)

For CY 2007, we proposed to calculate the median cost of APC 0384 (GI Procedures with Stents) using only claims that pass the device edits and which do not contain token charges for the device HCPCS codes on the claims. The proposed rule median cost of APC 0384 was $1,400.71.

Comment: The commenters asked that CMS calculate the median by applying the same device edits for CPT codes 43268 (Endoscopic retrograde cholangiopancreatography (ECRP); with retrograde insertion of tube or stent into bile or pancreatic duct); 43269 (Endoscopic retrograde cholangiopancreatography (ECRP); with retrograde removal of foreign body and/or change of tube or stent); and 43219 (Esophagoscopy, rigid or flexible; with insertion of plastic tube or stent) that were applied to calculate the CY 2006 OPPS median cost. The commenters stated that CMS used only claims containing stent device codes to calculate the median cost for APC 0384 for CY 2006 OPPS. They believed that the CY 2007 OPPS median cost for APC 0384 would be significantly higher if only claims that contained the stent device codes were used in the calculation.

Response: We have not calculated the CY 2007 median cost for APC 0384 using only claims that contain the HCPCS codes for stents for the procedures reported under CPT codes 43268 and 43219, because the procedures may be performed with tubes rather than stents. There are no device HCPCS codes for the tubes that may be used. Similarly, the procedure identified by CPT code 43269 may or may not use either a stent or a tube, and, therefore, it would be erroneous to require that a stent be reported on the claim. We assume that where a stent HCPCS code is not reported on the claim, the charge for the procedure incorporates the charge for the tube if one was used in the case of CPT codes 43268 and 43219, or in the case of CPT code 43269, we assume that no stent or tube was used at all. It is also possible that if the hospital inserted a tube, the hospital provided a charge for the tube under a revenue code with no HCPCS code. The other CPT codes in the APC require the use of a stent (and make no provision for substitution of a tube) and, therefore, we require that a stent HCPCS C-code be reported on the claims for those services. This is the same methodology and the same set of device edits for these procedures that were applied to calculate the median cost of APC 0384 to establish its CY 2006 OPPS payment rate. Our discussion of our final policy for setting the payment rates for device-dependent APCs, including APC 0384, is included in section IV.A.2. of this final rule with comment period. Start Printed Page 68052See the OPPS device edits at http://www.cms.hhs.gov/​HospitalOutpatientPPS/​ under “downloads” for the device edits in place for this APC for each calendar quarter since October 2005.

After carefully considering the public comments received, we are finalizing our CY 2007 proposal for APC 0384 without modification. The final median cost for APC 0384 is $1,402.31.

f. Endoscopy With Thermal Energy to Sphincter (APC 0422)

CPT code 43257 (Upper gastrointestinal endoscopy, including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease), effective January 1, 2005, is used for esophagoscopy with delivery of thermal energy to the muscle of the lower esophageal sphincter and/or gastric cardia for the treatment of gastresophageal reflux disease. This code describes the Stretta procedure, including use of the Stretta System and all endoscopies associated with the Stretta procedure. Prior to CY 2005, the Stretta procedure was recognized under HCPCS code C9701 from January 1, 2004, through December 31, 2004, in the OPPS. For the CY 2005 OPPS, HCPCS code C9701 was deleted and CPT code 43257 was utilized for the Stretta procedure. In CY 2005, the Stretta procedure was transitioned from a New Technology APC to clinical APC 0422 (Level II Upper GI Procedures) based on several years of hospital cost data. Procedures within APC 0422 were similar to the Stretta procedure in terms of clinical characteristics and resource use. For both CYs 2005 and 2006, we specifically calculated the median cost for the Stretta procedure reported with CPT code 43257 taking into account the codes that hospitals billed for the service in CYs 2003 and 2004, which included HCPCS code C9701 and one unit of endoscopy service. For CY 2007, we proposed to continue with the current APC assignment for the Stretta procedure, with no need for a special median cost calculation.

We received several public comments in response to the CY 2007 proposed payment rate for the Stretta procedure, in particular with a focus on the median cost methodology.

Comment: Some commenters objected to the APC assignment of the Stretta procedure to APC 0422 and cited the use of the CY 2004 claims data in determining its median cost for CY 2007. The commenters indicated that CMS should recalculate the median cost for CPT code 43257 to ensure that all claims contributing to the median reflect the resources of the endoscopic procedures that are part of this procedure.

Response: The commenters cited the CY 2004 claims as part of their objection. However, we used claims data from CY 2005 for all services, including CPT code 43257, in determining the payment rates for CY 2007. As we stated in the CY 2007 OPPS proposed rule, median costs for the CY 2007 OPPS update were based on the CY 2005 hospital claims data. APC assignments are based on clinical homogeneity and comparable resource utilization for all CPT and HCPCS codes within an APC. In the case of APC 0422, we believe that the procedures assigned to this APC are similar in costs and resource consumption, with median costs for the significant procedures assigned to the APC of $1,475 to $2,084, well within the 2 times rule limits.

Comment: Several commenters requested that CMS create a new APC that includes both CPT codes 43257 and 0008T (Upper gastrointestinal endoscopy, including esophagus, stomach, and either the duodenum and/or jejunum as appropriate, with suturing of the esophagogastric junction) to appropriately cover the costs associated with performing these procedures. One commenter requested that CMS create a new APC to which CMS would assign CPT codes 43257 and 0008T, and that CMS use a different methodology to calculate the median cost. The commenter indicated that because CPT codes 43228 and 43830 have higher volumes but lower costs, the inclusion of them in the same APC as CPT code 43257 does not lead to payment of CPT code 43257 at a level that is appropriate to pay the costs of the service. The same commenter indicated that the continued inclusion of CPT codes 43228 and 43830 decrease the payment rate for many of the procedures placed in APC 0422. The commenter believed that creating the new APC was analogous to what CMS proposed to do for vascular access devices in the proposed rule.

Response: We disagree with the commenters. We believe that the procedures in APC 0422 contain similar procedures for the treatment of gastroesophageal reflux disease, and these services are, therefore, appropriately assigned based on clinical homogeneity and resource use. Thus, for CY 2007, CPT code 43257 will remain in APC 0422. CPT code 0008T will be deleted as of January 1, 2007. For the CY 2007 OPPS, the payment for APC 0422 is based on the final median cost of $1,573.89. Furthermore, with regard to the commenter's analogy to a new APC for vascular access devices, such a comparison was misplaced as we did not propose to create a new APC for vascular access devices in the CY 2007 OPPS proposed rule.

Comment: One commenter requested that CMS recompute the median cost for CPT code 43257, and suggested two specific options for determining a revised median cost. One option suggested by the commenter was that CMS add the median cost for CPT code 43235 to the cost of all claims for HCPCS code C9701 (CPT code 43257 in CY 2005) that did not also contain at least one unit of an endoscopy code on the claim. The commenter indicated that these inflated claims costs would then be combined with all claims for HCPCS code C9701 that also contain at least one unit of an endoscopy code and with the claims for CPT code 0008T to set the median cost for the APC they wanted CMS to create. The commenter suggested that another option would be to use only claims that contained both HCPCS code C9701 and CPT codes 43234, 42235, or any other endoscopy code to calculate the median cost, which the commenter admitted would not yield as robust a set of claims for setting medians.

Response: We no longer have a need for special calculations to develop the median cost of CPT code 43257 because the code itself was reported by hospitals in CY 2005 and includes all endoscopies. In addition, HCPCS code C9701 was deleted for CY 2005 so we have no claims for the service from that year. Further, as we indicated in the CY 2006 OPPS final rule with comment period that addressed this same issue and similar comment (70 FR 68606), we see no reason to create a new APC for CPT codes 43257 and 0008T. We believe that the procedures in APC 0422 contain similar procedures for the treatment of gastroesophageal reflux disease, and therefore, the APC is appropriately structured based on clinical homogeneity and resource use.

After carefully considering the public comments received, we are finalizing our proposal for assignment of CPT code 43257 to APC 0422 for CY 2007, with a median cost of $1,573.89.

5. Ocular Procedures

a. Keratoprosthesis (APC 0293)

CPT code 65770 (Keratoprosthesis) is a surgical procedure for implantation of a keratoprosthesis, an artificial cornea. In the CY 2007 proposed rule, we indicated that we believed that the keratoprosthesis device that is required Start Printed Page 68053for the implantation is described by HCPCS code C1818 (Integrated keratoprosthesis), a device category that received transitional pass-through payment under the OPPS from July 2003 through December 2005. When the pass-through status for the device expired for CY 2006 and the costs of the device were packaged into the implantation procedure, CPT code 65770 continued to be assigned to APC 0244 (Corneal Transplant), with a payment rate of about $2,275, despite an increase in the median cost of the implantation procedure of about $1,200 associated with the packaging of the device. There is no 2 times violation in APC 0244 for CY 2006.

At the March 2006 meeting of the APC Panel, following a presentation regarding the procedure to implant a keratoprosthesis that described the clinical and hospital resource characteristics of CPT code 65770, the Panel recommended moving CPT code 65770 to a more appropriate APC in order to make appropriate payment. We agreed with the recommendation of the APC Panel. At the time of the proposed rule, claims data from CY 2005 demonstrated that the median cost for implantation of a keratoprosthesis of $3,127.51 remained significantly higher than the median costs of other procedures assigned to APC 0244, although there was no 2 times violation. In addition, CPT code 65770 contributed less than 1 percent of the single claims in the APC available for ratesetting, and it was likely to continue to be an uncommon procedure among Medicare beneficiaries, resulting in its persistent small contribution to the median cost of APC 0244. Therefore, for CY 2007, we proposed to create a new APC 0293 (Level V Anterior Segment Eye Procedures) with a median cost of $3,127.51 and to move CPT code 65770 into that APC in order to more appropriately pay for the procedure and the related device. CPT code 65770 was the only code proposed for assignment to that APC.

Comment: One commenter and a presenter to the APC Panel during its August 2006 meeting requested that the procedure be paid at a higher rate than the proposed payment rate. They believed that our cost data were inaccurate and understated the cost of the implantable device, HCPCS code C1818. The commenters reported that the device, a biointegratable artificial cornea, costs approximately $7,000, far more than the proposed $3,116.62 OPPS payment rate for the procedure to implant the device.

At its August 2006 meeting, the APC Panel recommended that CMS consider external data for these procedures to validate whether the claims used for ratesetting were properly coded and make appropriate adjustments to the OPPS payment rate if necessary. Further, the Panel recommended that CMS implement a device edit that would ensure that the device code (HCPCS code C1818) is included on claims for the keratoprosthesis procedure.

The commenters provided hospital data that showed that many hospitals that performed the procedure which may be reported for implantation of the costly biointegratable artificial cornea described by HCPCS code C1818 did not report charges for the device on their bills to Medicare. Further, one commenter performed analyses of Medicare hospital outpatient claims data and found that if CMS used only single procedure claims that included HCPCS code C1818 and CPT code 65770 to establish the median cost for APC 0293, it would be more than $10,000 and would result in a payment rate that would be adequate to cover the costs of implantation of the integrated keratoprosthesis device.

Response: In response to the comments and the APC Panel's recommendations, we performed additional analyses of our claims data. We noted that a new alphanumeric HCPCS code L8609 (Artificial cornea) was established in CY 2006, but there would not have been any claims reported for this code in the CY 2005 claims data used for this CY 2007 OPPS update. We found that only 8 of the 47 single claims for CPT code 65770 included the HCPCS device code C1818. The median cost for those few claims was $10,715.30, consistent with the commenter's data analyses.

Upon further exploration of the background of HCPCS device code C1818, we noted that we had provided specific guidance concerning the device code in the June 2003 Transmittal A-03-051, explaining, “The device is composed of a flexible, one-piece biocompatible polymer * * *.” We are aware of at least one other device that may be inserted during the procedure described by CPT code 65770, and that keratoprosthesis is a two-part device that would not be appropriately described by HCPCS code C1818. We have been told that the device is significantly less costly than the device described by HCPCS code C1818, the one-piece biointegratable keratoprosthesis. Because there are at least two devices with different costs that could have been used in CY 2005 to perform CPT code 65770, but there was no HCPCS code in CY 2005 for the two-part keratoprosthesis not described by HCPCS code C1818, it would not be appropriate for us to use only claims reporting HCPCS code C1818 to calculate the median cost for CPT code 65770. If we were to follow the recommendation of the commenter, we could be systematically and incorrectly excluding claims for CPT code 65770 that may have been correctly coded at the time by hospitals implanting a two-part keratoprosthesis with a lower device cost than the cost of the one-piece device coded by CPCS code C1818.

The OPPS is a prospective payment system that pays based on the median cost of procedures assigned to APC groups, and to the extent that various devices with dissimilar costs may be used to provide the same procedure, those different device costs are packaged into the procedural payment in relationship to their utilization in the procedure. Therefore, we do not believe the 47 single claims from CY 2005 used for ratesetting for APC 0293 were miscoded, and we do not believe adjustments to the payment rate for APC 0293 established based on the standard OPPS methodology are needed for CY 2007.

Where there are device HCPCS codes for all possible devices that could be used to perform a procedure that always requires a device and the APC is designated a device-dependent APC, we have commonly instituted device edits that prevent payment of claims that do not include both the procedure and an acceptable device code. In that way, hospitals become aware of the proper coding requirements, and we can be confident that our procedure claims include charges for the necessary devices so we can establish appropriate payment rates for those procedures.

Because there was a new, more general HCPCS L-code (L8609) created for the artificial cornea in CY 2006 that may be used to report all keratoprostheses not already described by HCPCS code C1818, we are accepting the APC Panel's recommendation regarding the establishment of device edits for CPT code 65770. We will establish a device edit in CY 2007 for CPT code 65770 that requires reporting of an appropriate device HCPCS code to ensure that all claims for CPT code 65770 in CY 2007 and future years include charges for a required device. However, to the extent that devices with different costs are used to provide the keratoprosthesis procedure, unless the CPT code descriptor for the service is revised or more specific CPT codes are developed, our claims data will continue to reflect highly variable costs Start Printed Page 68054for the services that are provided using the full spectrum of keratoprosthesis devices.

After carefully considering the comments received, we are adopting our proposal without modification to assign CPT code 65770 to APC 0293, with a median cost of $3,177.05 for CY 2007. We are also assigning a procedure-to-device edit for CPT code 65770 with APC 0293.

b. Eye Procedures (APCs 0232, 0235, and 0241)

In Addendum B of the CY 2007 proposed rule (71 FR 49702), we proposed to assign a payment rate of $368.07 for APC 0232 (Level I Anterior Segment Eye Procedures), a payment rate of $250.82 for APC 0235 (Level I Posterior Segment Eye Procedures), and a payment rate of $1,529.55 for APC 0241 (Level IV Repair and Plastic Eye Procedures).

Comment: Several commenters questioned the reasoning behind the payment reductions for APCs 0232, 0235, and 0241 when their facilities experienced increased costs for the procedures assigned to these APCs. Specifically, the commenters questioned why the payment rate for APC 0232 declined from $411.84 for CY 2006 to the proposed payment rate of $368.07 for CY 2007; why the payment rate for APC 0235 declined from $285.21 for CY 2006 to the proposed payment rate of $250.82 for CY 2007; and why the payment rate for APC 0241 declined from $1,806.03 for CY 2006 to the proposed payment rate of $1,529.55 for CY 2007. At the same time, several commenters supported the proposed payment increases for APCs 0242 (Level V Repair and Plastic Eye Procedures), 0245 (Level I Cataract Procedures without IOL Insert), 0247 (Laser Eye Procedures Except Retinal), 0248 (Laser Retinal Procedures), 0673 (Level IV Anterior Segment Eye Procedures), and 0699 (Level IV Eye Tests and Treatment). The commenters requested that CMS reexamine the proposed payments for APCs 0232, 0235, and 0241.

Response: Each year, we reevaluate APC assignments for procedures, services, and items paid under the hospital OPPS based on claims data paid by Medicare to set annual payment rates. Based on our analyses, we make changes to the APC assignments when necessary. As we stated in the CY 2007 OPPS proposed rule (71 FR 49514), we used approximately 50.7 million whole claims that reflected services furnished on or after January 1, 2005, and before January 1, 2006, to recalibrate the APC relative payment weights for CY 2007. While the payment rates for many APCs remain stable over time, in the absence of APC reconfiguration, it is not unusual for the payment rates for certain APCs to vary modestly from year to year, similar to the approximately 10-percent decrease in median costs observed for APCs 0232 and 0235 for CY 2007. However, as the commenters noted, other eye procedure APCs also had proposed increases for CY 2007. The CY 2007 median costs for APCs 0232 and 0235 have been calculated based upon CY 2005 claims using the standard OPPS methodology. In the case of APC 0241, the commenter is mistaken to believe that the CY 2006 OPPS payment rate for the APC was $1,806.03. The CY 2006 OPPS payment rate for APC 0241 was $1,378.76. Therefore, the proposed payment rate of $1,529.55 for APC 0241 was a proposed payment rate increase for CY 2007.

After carefully considering the public comments received, we are finalizing our CY 2007 proposal for APCs 0232, 0235, and 0241 without modification, with final median costs of $370.77, $240.36, and $1,543.32, respectively.

c. Amniotic Membrane for Ocular Surface Reconstruction

In Addendum B of the CY 2007 proposed rule (71 FR 49845), we proposed to assign HCPCS code V2790 (Amniotic membrane for surgical reconstruction, per procedure) to status indicator “N” (packaged).

Comment: Several commenters requested that CMS consider assigning status indicator “F” (paid at reasonable cost) to HCPCS code V2790 rather than status indicator “N”. One commenter indicated a discrepancy in payment policy and status indicator assignment for two types of tissues currently used for ocular surface transplants; that is, HCPCS code V2785 (Processing, preserving and transporting corneal tissue), which is assigned to status indicator “F” and HCPCS code V2790, which is assigned to status indicator “N,” are not treated similarly with regard to status indicator assignments and OPPS payment policy. The commenters added that payment for items and services assigned to status indicator “N” is packaged into payment for the associated procedures, while payment for items and services assigned to status indicator “F” is made at reasonable cost, not under the OPPS.

The commenters believed this discrepancy could create a competitive disadvantage and financial disincentive for hospitals to promote the treatment of ocular surface diseases using amniotic membrane tissue, and ultimately impede beneficiary access to this unique ocular reconstructive procedure. The commenters requested that CMS reassign HCPCS code V2790 from status indicator “N” to status indicator “F” for CY 2007.

Response: We appreciate the commenters” interest in payment for tissues used in ocular treatments. The OPPS has provided separate payment for corneal tissue acquisition at reasonable cost since the beginning of the OPPS, due to the highly variable corneal tissue processing fees required for eye banks to provide safe corneal tissue from donors as needed for transplant, through special distribution channels. These costs may vary substantially and unpredictably, depending on philanthropic and in-kind service contributions to eye banks that vary from community to community and from year to year. Our understanding is that amniotic membrane retrieved from donated placental tissues is a processed, cryopreserved, and commercially marketed product used for ocular reconstruction that may be stocked and stored by hospitals. Therefore, there is no need for HCPCS code V2790 to be paid based on reasonable cost outside of the OPPS. Instead, like many items under the OPPS used in surgical procedures, its prospective payment is appropriately packaged into payment for the procedures in which it is used.

After consideration of the public comments received, we are finalizing our proposed CY 2007 payment policies without modification for HCPCS codes V2785 and V2790 as reflected in their assigned status indicators.

6. Other Procedures

a. Skin Replacement Surgery and Skin Substitutes (APC 0025)

For CY 2006, the AMA made comprehensive changes, including code additions, deletions, and revisions, accompanied by new and revised introductory language, parenthetical notes, subheadings and cross-references, to the Integumentary, Repair (Closure) subsection of surgery in the CPT book to facilitate more accurate reporting of skin grafts, skin replacements, skin substitutes, and local wound care. In particular, the section of the CPT book previously titled “Free Skin Grafts” and containing codes for skin replacement and skin substitute procedures was renamed, reorganized, and expanded. New and existing CPT codes related to skin replacement surgery and skin substitutes were organized into five subsections: Surgical Preparation, Autograft/Tissue Cultured Autograft, Acellular Dermal Replacement, Start Printed Page 68055Allograft/Tissue Cultured Allogeneic Skin Substitute, and Xenograft.

As part of the CY 2006 CPT code update in the newly named “Skin Replacement Surgery and Skin Substitutes” section, certain codes were deleted that previously described skin allograft and tissue cultured and acellular skin substitute procedures, including CPT code 15342 (Application of bilaminate skin substitute/ neodermis; 25 sq cm), CPT code 15343 (Application of bilaminate skin substitute/neodermis; each additional 25 sq cm), CPT code 15350 (Application of allograft, skin; 100 sq cm or less), and CPT code15351 (Application of allograft, skin; each additional 100 sq cm). Thirty-seven new CPT codes were created in the “Skin Replacement Surgery and Skin Substitutes” section, and these codes received interim final status indicators and APC assignments in the CY 2006 final rule with comment period and were subject to comment. At its March 2006 meeting, the APC Panel heard several presentations on some of the new CY 2006 CPT codes for skin replacement and skin substitute procedures, and CMS has received additional information from the public regarding a number of these services. In particular, 18 new CPT codes that were created to more specifically describe skin allograft, skin replacement, and skin substitute procedures were the subject of the APC Panel discussion and recommendations. These codes are as follows:

  • CPT code 15170 (Acellular dermal replacement, trunk, arms, legs; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15171 (Acellular dermal replacement, trunk, arms, legs; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15175 (Acellular dermal replacement, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15176 (Acellular dermal replacement, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15300 (Allograft skin for temporary wound closure, trunk, arms, legs; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15301 (Allograft skin for temporary wound closure; trunk, arms, legs; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15320 (Allograft skin for temporary wound closure, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15321 (Allograft skin for temporary wound closure, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15340 (Tissue cultured allogeneic skin substitute; first 25 sq cm or less)
  • CPT code 15341 (Tissue cultured allogeneic skin substitute; each additional 25 sq cm)
  • CPT code 15360 (Tissue cultured allogeneic dermal substitute; trunk, arms, legs; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15361 (Tissue cultured allogeneic dermal substitute; trunk, arms, legs; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15365 (Tissue cultured allogeneic dermal substitute, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15366 (Tissue cultured allogeneic dermal substitute, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15420 (Xenograft skin (dermal), for temporary wound closure, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15421 (Xenograft skin (dermal), for temporary wound closure, face, scalp, eyelids, mouth neck, ears, orbits, genitalia, hands, feet and/or multiple digits; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof)
  • CPT code 15430 (Acellular xenograft implant; first 100 sq cm or less, or one percent of body area of infants and children)
  • CPT code 15431 (Acellular xenograft implant; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof).

The CY 2006 interim final APC assignments of these codes, the recommendations made by the APC Panel at its March 2006 meeting, and our proposed placement of the codes for CY 2007 were listed in Table 11 of the CY 2007 OPPS proposed rule (71 FR 49557). As noted in the proposed rule, in general, biological skin substitutes and replacements used in procedures described by these CPT codes were proposed for separate payment under the OPPS for CY 2007, according to the methodology outlined in section V. of the preamble of the proposed rule (71 FR 49557) and discussed in this preamble.

As we indicated in the proposed rule (71 FR 49558), we reviewed the presentations to the APC Panel; the APC Panel's recommendations; the CPT code descriptors, introductory explanations, cross-references, and parenthetical notes; the clinical characteristic of the procedures; and the code-specific median costs for all related CPT codes available from our CY 2005 claims data. While we agreed with the APC Panel that the codes currently placed in APC 0024 (Level I Skin Repair) should be assigned to an APC with a higher median cost for CY 2007, we disagreed that these procedures should be placed in APC 0027 (Level IV Skin Repair). The APC Panel presenters reasoned that some of the codes (CPT codes 15170, 15175, 15320, 15340, 15360, 15365, 15420, and 15430) for the first increment of body surface area treated should be placed in APC 0027 because they are similar to CPT code 15300 (Allograft skin for temporary wound closure, trunk, arms, legs; first 100 sq cm or less, or one percent of body area of infants and children). Upon further review of the clinical and expected hospital resource characteristics of CPT code 15300, we asserted in the proposed rule that this procedure was not appropriately placed in APC 0027. Split-thickness and full thickness skin autograft procedures currently assigned to APC 0027 were likely to require greater hospital resources, including additional operating room time and special equipment, in comparison to application of a separately paid allograft skin product. Instead, for CY 2007 we proposed to reassign CPT code 15300 to APC 0025 (Level II Skin Repair), with an APC median cost of $314.58. We agreed, in principle, that other CPT codes for the first increment of body surface area treated with a skin replacement or skin substitute were similar clinically and from a hospital resource perspective to CPT code 15300 and, therefore, we Start Printed Page 68056proposed to assign these procedures to APC 0025 as well for CY 2007.

Similarly, presenters reasoned that the related add-on codes (CPT codes 15171, 15176, 15321, 15342, 15361, 15366, 15421, and 15431) for procedures to treat additional body surface areas are similar to CPT code 15301 (Allograft skin for temporary wound closure, trunk, arms, legs; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof) in terms of required hospital resources. CPT code 15301 is assigned to APC 0025 for CY 2006. We proposed to maintain the assignment of CPT code 15301 to APC 0025 for CY 2007 and to reassign the other add-on codes to this APC. Note that APC 0025 has a status indicator of “T,” so that the add-on codes would experience the standard OPPS multiple surgical procedure reduction when properly billed with the first body surface area treatment codes that are assigned to the same clinical APC. We asserted in the proposed rule that this reduction in payment for the procedural resources associated with the add-on services was appropriate. (71 FR 49558).

The APC Panel did not hear any presentations or make any recommendations regarding skin substitutes or skin replacement codes and APCs at its August 2006 meeting.

Comment: One commenter on the CY 2006 final rule requested that we reassign CPT codes 15340 and 15341 to APC 0025, where the services would be grouped with clinically related services that require comparable hospital resources. In particular, the commenter noted that APC 0024 did not provide appropriate payment for the costs of surgical debridement of the wound to prepare it properly for application of the allogeneic skin substitute. Several commenters on the CY 2007 proposed rule supported our proposal to assign new CPT codes 15340 and 15341 to APC 0025. One commenter noted that the proposed assignments of these CPT codes for tissue cultured allogeneic skin substitutes to APC 0025 for CY 2007 would correct substantial reductions in payment for application of one product that occurred with the assignment of these CPT codes to APC 0024 for CY 2006. The commenter believed that our proposal represented a significant step toward the appropriate payment for these services. The commenter further claimed that its external analyses of Medicare claims data supported the change, with a median cost for new CPT code 15340 that was higher than the median cost of APC 0025 but lower than the median cost of APC 0027.

Response: We appreciate the recognition from the commenter that the proposed assignments of CPT codes 15340 and 15341 to APC 0025 provides more appropriate payment for these services.

Comment: A commenter supported our CY 2007 proposed assignments of CPT codes 15170 through 15176, 15300-15321, 15340-15366, and 15420-15431 to APC 0025. One commenter agreed that skin substitute or replacement add-on codes (CPT codes 15171, 15176, 15301, 15321, 15341, 15361, 16366, 15421, and 15431) should be placed in APC 0025. Another commenter provided significant clinical detail about dermal replacement services, described by CPT codes 15170 through 15176, and about temporary wound closure by allograft services, described by CPT codes 15300 through 15321. In contrast to our proposal, the commenters believed that, based on the clinical characteristics and expected costs including anesthesia, procedure room time, supplies, and preparation of the products for application, these services would be most appropriately assigned to APC 0686 (Level III Skin Repair). They believed that CMS had underestimated the resources required to perform these procedures.

Response: While the commenters provided comparisons among the expected relative costs of various procedures, the commenter provided no specific cost analyses to persuade us to assign CPT codes 15170 through 15176 and 15300 through 15321 to a skin repair APC that would provide payment at two and a half times the proposed payment rate for these services. We do not agree that the clinical and resource distinctions between these procedures and other services also assigned to APC 0025 would warrant their reassignment to APC 0686, with its significantly higher payment rate than their CY 2007 proposed payment rate. We note that we will have claims data for all of these CPT codes available for the CY 2008 OPPS update.

After carefully considering the public comments received, we are finalizing our proposed assignments of skin substitute and skin replacement procedures as shown in Table 16 below without modification.

Start Printed Page 68057

b. Treatment of Fracture/Dislocation (APCs 0062, 0063, and 0064)

APC 0046 (Open/Percutaneous Treatment Fracture or Dislocation) was a large clinical APC to which many procedures related to the percutaneous or open treatment of fractures and dislocations are assigned for CY 2006. Most of the approximately 100 procedures in the APC are relatively low volume, with even fewer single bills available for ratesetting. The median costs of the significant procedures in this APC as configured for CY 2006 range from a low of about $1,415 to a high of about $3,893. We received comments to the CY 2006 proposed rule (70 FR 42674) requesting that we distinguish procedures containing “with or without external fixation” in their descriptors to provide greater payments when external fixation is used to treat fractures. The commenters explained that when external fixation devices are used, the costs of the procedures increase, and, therefore, the current APC placement significantly underpays those procedures in those instances. In the CY 2006 final rule with comment period (70 FR 68607), we declined to reassign procedures that could include external fixation at that time but we acknowledged that we had treated APC 0046 as an exception to the 2 times rule for several years. For CY 2006, we again treated APC 0046 as an exception to the 2 times rule, but noted we would ask the APC Panel to consider whether this APC could be reconfigured to improve its clinical and resource homogeneity.

At the March 2006 meeting of the APC Panel, we asked the Panel to consider a possible reconfiguration of APC 0046 based on partial year CY 2005 claims data. The reconfiguration would create three new APCs and would divide the codes in APC 0046 among Start Printed Page 68058them. The APC Panel recommended that CMS continue to evaluate the refinement of APC 0046 into at least three APC levels, with consideration of a fourth level should data support this additional level. We accepted the APC Panel's recommendation and proposed for CY 2007 to split APC 0046 into three new APCs: APC 0062 (Level I Treatment Fracture/Dislocation); APC 0063 (Level II Treatment Fracture/Dislocation); and APC 0064 (Level III Treatment Fracture/Dislocation). To ensure clinical and resource homogeneity in the new APCs, their proposed configurations were based on the procedure code descriptors, clinical considerations specific to each procedure, and service-specific hospital resource utilization as shown in the claims data from CY 2005. Restructuring APC 0046 into these three new APCs eliminated 2 times rule violations in the Fracture/Dislocation series.

The APC Panel did not hear any presentations or make any recommendations regarding APC 0046 or our proposed APCs 0062, 0063, and 0064 at its August 2006 meeting.

We did not propose a fourth APC level in the Fracture/Dislocation series because we did not believe our claims data were sufficiently robust and consistent from year to year to support differential payment for another service level. One code, CPT 27615 (Radical resection of tumor (e.g., malignant neoplasm), soft tissue of leg or ankle area), was not clinically coherent with the other procedures in APC 0046, and we proposed to reassign this procedure outside of the Fracture/Dislocation series to APC 0050 (Level II Musculoskeletal Procedures Except Hand and Foot) for CY 2007.

We received two supportive comments on our proposed reconfiguration of APC 0046. A summary of the comments and our response follow:

Comment: A few commenters supported our proposal to move from one APC (0046) to three APCs (0062, 0063, and 0064) for services that treat fractures and dislocations. The commenters noted that three APCs better recognize the differences in hospital resource utilization. The commenters noted that OPPS payments would increase significantly for the highest level of fracture and dislocation treatment, decrease for the lowest level, and remain relatively stable for the medium treatment level.

Response: We appreciate the acknowledgement that we are attempting to better recognize the differences in hospital resource utilization for fracture and dislocation procedures.

We note that AMA's CPT Editorial Panel has deleted CPT 25611 (Percutaneous skeletal fixation of distal radial fracture (e.g., Colles or Smith type) or epiphyseal separation, with or without fracture of ulnar styloid, requiring manipulation, with or without external fixation) for CY 2007, replacing it with CPT code 25606 (Percutaneous skeletal fixation of distal radial fracture or epiphyseal separation). AMA's CPT Editorial Panel has also deleted CPT code 25620 (Open treatment of distal radial fracture (e.g., Colles or Smith type) or epiphyseal separation, with or without fracture of ulnar styloid, with or without internal or external fixation) for CY 2007, replacing it with three CPT codes as refinements: CPT code 25607 (Open treatment of distal radial extraarticular fracture or epiphyseal separation, with internal fixation); CPT code 25608 (Open treatment of distal radial intraarticular fracture or epiphyseal separation; with internal fixation of two fragments); and CPT code 25609 (Open treatment of distal radial intraarticular fracture or epiphyseal separation; with internal fixation of three or more fragments). These changes are effective January 1, 2007. The interim final APC assignments of the new CY 2007 CPT codes for fracture treatments are included in Table 17 below.

After carefully considering the comments received, we are finalizing our proposal without modification to reconfigure CY 2006 APC 0046 for fracture and dislocation procedures into three new APCs for CY 2007, APCs 0062, 0063, and 0064, as displayed in Table 17, and to reassign CPT code 27615 to APC 0050.

Table 17.—Reconfiguration of APC 0046

HCPCS codeDescriptionCY 2007 APC
21336Treat nasal septal fracture0063
21805Treatment of rib fracture0062
23515Treat clavicle fracture0064
23530Treat clavicle dislocation0063
23532Treat clavicle dislocation0062
23550Treat clavicle dislocation0063
23552Treat clavicle dislocation0063
23585Treat scapula fracture0064
23615Treat humerus fracture0064
23616Treat humerus fracture0064
23630Treat humerus fracture0064
23660Treat shoulder dislocation0063
23670Treat dislocation/fracture0064
23680Treat dislocation/fracture0063
24515Treat humerus fracture0064
24516Treat humerus fracture0064
24538Treat humerus fracture0062
24545Treat humerus fracture0064
24546Treat humerus fracture0064
24566Treat humerus fracture0062
24575Treat humerus fracture0064
24579Treat humerus fracture0064
24582Treat humerus fracture0062
24586Treat elbow fracture0064
24587Treat elbow fracture0064
24615Treat elbow dislocation0064
24635Treat elbow fracture0064
24665Treat radius fracture0063
Start Printed Page 68059
24666Treat radius fracture0064
24685Treat ulnar fracture0063
25515Treat fracture of radius0063
25525Treat fracture of radius0063
25526Treat fracture of radius0063
25545Treat fracture of ulna0063
25574Treat fracture radius & ulna0064
25575Treat fracture radius/ulna0064
25606 (25611 deleted)Treat fx distal radial0062
25607 (25620 deleted)Treat fx rad extra-articul0064
25608 (25620 deleted)Treat fx rad intra-articul0064
25609 (25620 deleted)Treat fx radial 3+ frag0064
25628Treat wrist bone fracture0063
25645Treat wrist bone fracture0063
25651Pin ulnar styloid fracture0062
25652Treat fracture ulnar styloid0063
25670Treat wrist dislocation0062
25671Pin radioulnar dislocation0062
25676Treat wrist dislocation0062
25685Treat wrist fracture0062
25695Treat wrist dislocation0062
26608Treat metacarpal fracture0062
26615Treat metacarpal fracture0063
26650Treat thumb fracture0062
26665Treat thumb fracture0063
26676Pin hand dislocation0062
26685Treat hand dislocation0063
26686Treat hand dislocation0064
26715Treat knuckle dislocation0063
26727Treat finger fracture, each0062
26735Treat finger fracture, each0063
26746Treat finger fracture, each0063
26756Pin finger fracture, each0062
26765Treat finger fracture, each0063
26776Pin finger dislocation0062
26785Treat finger dislocation0062
27202Treat tail bone fracture0063
27509Treatment of thigh fracture0062
27524Treat kneecap fracture0063
27566Treat kneecap dislocation0063
27615Remove tumor, lower leg0050
27756Treatment of tibia fracture0062
27758Treatment of tibia fracture0063
27759Treatment of tibia fracture0064
27766Treatment of ankle fracture0063
27784Treatment of fibula fracture0063
27792Treatment of ankle fracture0063
27814Treatment of ankle fracture0063
27822Treatment of ankle fracture0063
27823Treatment of ankle fracture0064
27826Treat lower leg fracture0063
27827Treat lower leg fracture0064
27828Treat lower leg fracture0064
27829Treat lower leg joint0063
27832Treat lower leg dislocation0063
27846Treat ankle dislocation0063
27848Treat ankle dislocation0063
28406Treatment of heel fracture0062
28415Treat heel fracture0063
28420Treat/graft heel fracture0063
28436Treatment of ankle fracture0062
28445Treat ankle fracture0063
28456Treat midfoot fracture0062
28465Treat midfoot fracture, each0063
28476Treat metatarsal fracture0062
28485Treat metatarsal fracture0063
28496Treat big toe fracture0062
28505Treat big toe fracture0063
28525Treat toe fracture0063
28531Treat sesamoid bone fracture0063
28545Treat foot dislocation0062
Start Printed Page 68060
28546Treat foot dislocation0062
28555Repair foot dislocation0063
28576Treat foot dislocation0062
28585Repair foot dislocation0063
28606Treat foot dislocation0062
28615Repair foot dislocation0063
28636Treat toe dislocation0062
28645Repair toe dislocation0063
28666Treat toe dislocation0062
28675Repair of toe dislocation0063

c. Complex Skin Repair (APC 0024)

In the CY 2007 OPPS proposed rule, we proposed to assign CPT code 13151 (Repair, complex, eyelids, nose, ears and/or lip, 1.1 cm to 2.5 cm, to APC 0024 (Level I Skin Repair) with a payment rate of $91.86.

Comment: One commenter asked why CPT code 13151 (Repair, complex, eyelids, nose, ears and/or lips; 1.1 cm to 2.5 cm) was assigned to APC 0024, rather than to APC 0025 (Level II Skin Repair). The commenter pointed out that the smaller skin repair represented by CPT code 13150 was assigned to APC 0025 with other more complex skin repair procedures.

Response: We agree with the commenter that CPT code 13151 would be more appropriated assigned to APC 0025 and are making that reassignment effective January 1, 2007.

d. Insertion of Posterior Spinous Process Distraction Device

The AMA released two new Category III codes on July 1, 2006, for insertion of a posterior spinous process distraction device, namely: 0171T (Insertion of posterior spinous process distraction device (including necessary removal of bone or ligament for insertion and imaging guidance), lumbar; single level); and 0172T (Insertion of posterior spinous process distraction device (including necessary removal of bone or ligament for insertion and imaging guidance), lumbar; each additional level (List separately in addition to code for primary procedure)). These two new codes are effective January 1, 2007. Moreover, we have created a new device category for transitional pass-through payment, effective January 1, 2007, C1821 (Interspinous process distraction device (implantable)), which we expect to be reported with these procedures. At its August 2006 meeting, the APC Panel recommended that CMS review the resources required for these new CPT codes and recommend appropriate APC assignments for them for CY 2007.

Comment: Some commenters indicated that CMS should place new procedure codes 0171T and 0172T into clinical APC 0051 (Level III Musculoskeletal Procedures Except Hand and Foot). Although the level of resources used in performing CPT code 0172T (second and subsequent level implants) is less than those used for CPT code 0171T (the single level implant of the device), the commenters believed that APC 0051 is also appropriate for 0172T because APC 0051 is subject to the multiple procedure discount. CPT code 0172T is an add-on code to the primary procedure reported with CPT code 0171T; therefore, payment for 0172T would always be reduced by 50 percent. One commenter stated that the resource elements they outlined specifically for CPT code 0172T are all costs incurred separately and in addition to the costs of the single level procedure, CPT code 0171T. The commenter believed it would be inappropriate to place CPT code 0172T into an APC based on the claimed resources, and then reduce the payment rate by 50 percent when a multiple procedure discount applies to every case that is correctly coded. The commenter provided charge data from seven claims for six different facilities that performed the single level procedure (CPT code 0171T). The commenter calculated a “median” of these charges reduced to cost of $2,727, which the commenter asserted was within the range of median costs of other procedures assigned to APC 0051. The commenter stated that it was unable to obtain any facility charge or cost data for CPT code 0172T. The commenter acknowledged that CMS had also granted transitional pass-through payment status for spinous process distraction devices effective January 1, 2007.

One commenter indicated that it expected the spinous process distraction device to remain on pass-through status through CY 2008 and, therefore, be paid separately through that time. However, the commenter expressed concern that once the device is no longer paid separately under pass-through payment, the device costs, which would be a substantial percentage of total procedural costs, would be packaged into payment for the procedural APC and adjusted by the wage index that is applied to 60 percent of the payment rate. The commenter requested that CMS address this issue, so that once payment for the spinous process distraction device is packaged into the procedural APC payment, hospitals with wage indices below 1.0 would be able to continue offering the procedure to patients.

Another commenter stated that it had performed four spinous process distraction device cases over the past year. All four cases had similar utilization patterns and outcomes. The commenter claimed to have evaluated the time and resources needed to complete the procedure, and compared the costs to other procedures, for example, laminectomies and diskectomies, performed at the hospital, and also extracted single procedure costs for all cases performed in APCs 0049 through 0052. The commenter determined that the costs of the four spinous process distraction device cases were most consistent with the costs of other services assigned to APC 0051.

Response: The commenters provided their recommendation based on their limited cost studies that relied on information from a few hospitals with experience implanting spinous process distraction devices. This is not unusual for new procedures, such as CPT Category III codes. We examined the procedural resource information provided by commenters as well as considered CY 2005 claims data for other musculoskeletal procedures in the OPPS. We believe that both of the procedures describe by CPT codes Start Printed Page 680610171T and 0172T would be most appropriately assigned to APC 0050 (Level II Musculoskeletal Procedures Except Hand and Foot), based on both clinical and expected resource considerations. Their assignment to the same clinical APC for CY 2007 will ensure appropriate payment for CPT code 0172T when the multiple procedure payment reduction is applied. We note that the device cost of HCPCS code C1821 (Interspinous process distraction device (implantable)), will be paid separately under the OPPS for at least 2 and not more than 3 years of pass-through payment. After that period, payment for the cost of the device would be packaged into the procedural APC payments for its implantation, most likely CPT codes 0171T and 0172T. At that time, we will further evaluate the most appropriate APC assignments for these procedures, as we will each year. For a discussion about application of the wage index to payments for APCs that have significant device costs, see section IV.A.2 of this final rule with comment period.

After carefully considering the public comments received, we are accepting the APC Panel's recommendation and assigning CPT codes 0171T and 0172T to APC 0050 with status indicator “T” for CY 2007. These assignments are interim final, and, therefore, open to comment in this final rule with comment period.

7. Medical Services

a. Medication Therapy Management Services

Following a presentation at its March 2006 meeting, the APC Panel made two recommendations regarding Category III CPT codes for pharmacist medication therapy management services that were new for CY 2006. These services include CPT codes 0115T (medication therapy management services provided by a pharmacist, individual, face-to-face with patient, initial 15 min., w/ assessment and intervention if provided; initial encounter), 0116T (medication therapy management; subsequent encounter), and 0117T (medication therapy management; additional 15 min.). These codes were assigned status indicator “B” in the CY 2006 OPPS final rule with comment period, indicating that they are not recognized by the OPPS when submitted on an outpatient hospital Part B bill type, with comment indicator “NI” to identify them as subject to comment. The APC Panel recommended that CMS create a new APC, with a nominal payment, to which we would assign these codes; implement the assignment in July 2006, if possible, or otherwise in CY 2007; and provide guidance to hospitals on how and when these codes should be reported. As indicated in the CY 2007 OPPS proposed rule (71 FR 49563), we did not accept the APC Panel's recommendations. Rather, we proposed to continue to assign status indicator “B” to CPT codes 0115T, 0116T, and 0117T for CY 2007.

According to the AMA, the purpose of Category III CPT codes is to facilitate data collection on and assessment of new services and procedures. Medication therapy management services are not new services in the OPPS, as they have been provided to patients by hospitals in the past as components of a wide variety of services provided by hospitals, including clinic and emergency room visits, procedures, and diagnostic tests. As such, in the CY 2007 proposed rule, we noted that we believe their associated hospital resource costs were already incorporated into the OPPS payments for these other services that are based on historical hospital claims data. The three Category III CPT codes specifically describe medication therapy management services provided by a pharmacist. We indicated that we had no need to distinguish medication therapy management services provided by a pharmacist in a hospital from medication therapy management services provided by other hospital staff, as the OPPS only makes payments for services provided incident to physicians' services. Hospitals providing medication therapy management services incident to physicians' services may choose a variety of staffing configurations to provide those services, taking into account other relevant factors such as State and local laws and hospital policies.

In the CY 2007 proposed rule, we explained that in general, we do not establish new clinical APCs for new codes and set payment rates for those APCs when we have no cost data for any services populating the APCs. New codes for which we believe that there are no existing clinical APCs compatible with their expected clinical and hospital resource characteristics are often assigned to New Technology APCs until we have sufficient cost data to determine appropriate clinical APC assignments. However, these medication therapy management codes would not be eligible to map to New Technology APCs because they are not new services that are unrepresented in historical hospital claims data. As stated earlier, because we believe the costs of medication therapy management services were imbedded as a component within our claims data, we were confident that our CY 2005 claims data reflected the costs of pharmacist medication management services provided to hospital outpatients who were receiving hospital services.

We received a large number of public comments concerning our proposal for CPT codes 0115T, 0116T, and 0117. A summary of the comments and our responses follows:

Comment: Most commenters requested that Medicare pay separately for medication therapy management because it is difficult for the hospital to provide this service without receiving any payment. One commenter elaborated on the emerging role of a pharmacist and the increasing scope of services provided by the pharmacist to the patient, including proactive assessments rather than simply reactive responses. This commenter stated that although the historical resource costs of the pharmacist's services may be captured in the claims data, it was unlikely that the resource costs of the new responsibilities are represented in the data. Another commenter quoted statistics that estimated that, in 2004, only 30 percent of hospitals had pharmacists who were involved in ambulatory care. Of those who were involved, only 50 percent had involvement in medication therapy management services. Therefore, although there may be cost data embedded in the claims, the fact that these services have historically been provided infrequently means that the costs of these services have minimal impact on our median cost data. Many commenters noted that these pharmacist services reduce costs in the long run by improving the health of patients. One commenter agreed that these services are already accounted for in the claims data and further agreed that there is no need to distinguish between services provided by pharmacists and other providers. One commenter suggested that medication therapy management could be provided to a patient on the same day as a laboratory test and requested that CMS clarify the appropriate billing technique under such circumstances. Another commenter specifically asked if it was appropriate to bill CPT code 99211, the lowest level clinic visit, if the only service provided to a patient is medication therapy management by a pharmacist. One commenter agreed that these services are not technically new, but suggested that CMS map them to New Technology APCs because they are new in the sense that they are now more Start Printed Page 68062readily available independent of a physician's service or clinic procedure. One pharmacy association objected to our statement that these services can be provided by staff other than pharmacists. The association notes that pharmacists have distinct training, skills, and abilities to perform these services, which are reflected in the new Category III codes.

Response: We agree with the commenters that medication therapy management services are important services provided to patients and that providers should receive payments for these services. We would expect the hospital charges for the services provided to the patient to include charges for all hospital resource costs associated with the patient's care, including medication therapy management services, if appropriate. As we stated above, medication therapy management services are not new services, and they have been provided in the past as components of a wide variety of services provided by hospitals, including clinic and emergency room visits, procedures, and diagnostic tests. Although we do not make separate payment for medication therapy management provided by a pharmacist, the costs for this service are included in the costs of other services furnished by the hospital on the same day. Therefore, we continue to believe that the costs for these services are embedded in our claims data, and are reflected in our payment rates, thereby providing payments for these important services. While we acknowledge commenters' concerns that hospitals are providing medication therapy management services more frequently than in the past, we continue to disagree that they are new and should be assigned to a New Technology APC. To the extent that medical management services evolve over time to require more facility resources due to their greater complexity, we expect those higher costs to be reflected in hospitals' charges for the associated services, which will then provide the basis for future ratesetting under the OPPS.

To clarify our billing requirements, if the only service provided to a patient is a laboratory test to determine medication levels, the laboratory test is all that should be billed. If a hospital provides a distinct, separately identifiable service in addition to the test, the hospital is responsible for billing the HCPCS code that most closely describes the service provided. Billing a visit code in addition to another service merely because the patient interacted with hospital staff or spent time in a room for that service is inappropriate. A hospital may bill a visit code, based on the hospital's own coding guidelines which must reasonably relate the intensity of hospital resources to the different levels of HCPCS codes. Services furnished must be medically necessary and documented.

After carefully considering the comments received, we are continuing to assign status indicator “B” to CPT codes 0115T, 0116T, and 0117T for CY 2007 and finalizing our proposed policy without modification.

b. Single Allergy Tests (APC 0381)

We proposed to continue with our methodology of differentiating single allergy tests (“per test”) from multiple allergy tests (“per visit”) by assigning these services to two different APCs to provide accurate payments for these tests in CY 2007. Multiple allergy tests are assigned to APC 0370 (Allergy Tests) with a median cost calculated based on the standard OPPS methodology. We provided billing guidance in CY 2006 in Transmittal 804 (issued on January 3, 2006) specifically clarifying that hospitals should report charges for the CPT codes that describe single allergy tests to reflect charges “per test” rather than “per visit” and should bill the appropriate number of units of these CPT codes to describe all of the tests provided. However, our CY 2005 claims data available for the CY 2007 proposed rule did not yet reflect the improved and more consistent hospital billing practices of “per test” for single allergy tests. Some claims for single allergy tests still appeared to provide charges that represented a “per visit” charge, rather than a “per test” charge. Therefore, consistent with our payment policy for CY 2006, we proposed to calculate a “per unit” median cost for APC 0381, based upon 349 claims containing multiple units or multiple occurrences of a single CPT code, where packaging on the claims was allocated equally to each unit of the CPT code. Using this methodology, we calculated a median cost of $13.29 for APC 0381 for CY 2007. As indicated in the CY 2007 OPPS proposed rule (71 FR 49566), we were hopeful that the better and more accurate hospital reporting and charging practices for these single allergy test CPT codes beginning in CY 2006 would allow us to calculate the median cost of APC 0381 using the standard OPPS process in future OPPS updates.

We did not receive any public comments concerning our proposed methodology for differentiating single allergy tests from multiple allergy tests for OPPS payment in CY 2007. The final CY 2007 APC 0381 median cost calculated based upon 382 single claims, using the methodology as proposed, is $16.43.

c. Hyperbaric Oxygen Therapy (APC 0659)

When hyperbaric oxygen therapy (HBOT) is prescribed for promoting the healing of chronic wounds, it typically is prescribed for 90 minutes and billed using multiple units of HBOT on a single line or multiple occurrences of HBOT on a claim. In addition to the therapeutic time spent at full hyperbaric oxygen pressure, treatment involves additional time for achieving full pressure (descent), providing air breaks to prevent neurological and other complications from occurring during the course of treatment, and returning the patient to atmospheric pressure (ascent). The OPPS recognizes HCPCS code C1300 (Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval) for HBOT provided in the hospital outpatient setting.

In the CY 2005 final rule with comment period (69 FR 65758 through 65759), we finalized a “per unit” median cost calculation for APC 0659 (Hyperbaric Oxygen) using only claims with multiple units or multiple occurrences of HCPCS code C1300 because delivery of a typical HBOT service requires more than 30 minutes. We observed that claims with only a single occurrence of the code were anomalies, either because they reflected terminated sessions or because they were incorrectly coded with a single unit. In the same rule, we also established that HBOT would not generally be furnished with additional services that might be packaged under the standard OPPS APC median cost methodology. This enabled us to use claims with multiple units or multiple occurrences. Finally, we also used each hospital's overall CCR to estimate costs for HCPCS code C1300 from billed charges rather than the CCR for the respiratory therapy cost center. Comments on the CY 2005 proposed rule effectively demonstrated that hospitals report the costs and charges for HBOT in a wide variety of cost centers. We used this methodology to estimate payment for HBOT in CYs 2005 and 2006. For CY 2007, we proposed to continue using the same methodology to estimate a “per unit” median cost for HCPCS code C1300. Using 50,311 claims with multiple units or multiple occurrences, we estimated a median cost of $98.36 for CY 2007.

Comment: One commenter agreed with CMS' approach to determining the median costs for HCPCS code C1300 Start Printed Page 68063(HBOT) to the extent that it eliminated services that were obviously billed incorrectly. The commenter believed that use of the hospital's overall CCR appeared to be the best option at this time. However, the commenter asked that hospitals be allowed to bill these services with multiple revenue codes (not just respiratory therapy), so that hospitals could bill the services under the revenue code that was most closely linked to the cost center where the services were furnished. The commenter also requested that the revenue code to cost center crosswalk be revised to reflect the use of the hospital's overall CCR for HBOT.

In contrast, another commenter was concerned that CMS' claims data do not accurately reflect the costs of this therapy because of potential hospital miscoding. The commenter believed that the use of hospitals' overall CCRs did not reflect the relationship between costs and charges specific to HBOT. The commenter believed that the payment rate for HCPCS code C1300 continued to be inadequate as proposed for CY 2007 and asked that the rate be increased based on the external data provided by an association to the APC Panel.

Another commenter objected to erratic payment rates for HBOT over a period of years, particularly a drop in payment between CYs 2004 and 2005. The commenter attributed this instability both to the confusion of hospitals regarding proper coding of treatment units and to CMS' inability to determine an appropriate CCR for HBOT because hospitals reported their costs under many cost centers. The commenter recommended that CMS use an external analysis that it indicated reproduces an accurate CCR for HBOT, calculated using a consistent and transparent methodology.

Response: We believe that the final median cost for APC 0659 ($97.20 per unit) is an appropriate relative cost to be used to set the weights upon which the HBOT payment will be based.

CY 2007 is the third year in which we have used a special methodology to develop the median cost for HBOT services that removed obviously erroneous claims and deviated from our standard methodology of using departmental CCRs, when available, to convert hospitals' charges to costs. Prior to CY 2005, our inclusion of significant numbers of miscoded claims in the median calculation for HBOT and our exclusion of the claims for multiple units of treatment, the typical scenario, resulted in payment rates that were artificially elevated. As explained earlier, beginning in CY 2005 and continuing through the present, we have adjusted the CCR used in the conversion of charges to costs for these services so that claims data would more accurately reflect the relative costs of the services. The median costs of HBOT calculated using this methodology have been reasonably stable for the last 3 years. We believe that this adjustment through use of the hospitals' overall CCRs is all that is necessary to yield a valid median cost for establishing a scaled weight for HBOT services.

After carefully considering the public comments received, we are finalizing our proposed methodology for estimating a “per unit” median cost for HCPCS code C1300, assigned to APC 0659, without modification for CY 2007.

d. Guidance for Chemodenervation (APC 0215)

For CY 2006, new CPT codes 95873 (Electrical stimulation for guidance in conjunction with chemodenervation) and 95874 (Needle electromyography for guidance in conjunction with chemodenervation) were provided interim final assignments to APC 0215 (Level I Nerve and Muscle Tests). The proposed APC assignments of the codes for CY 2007 were unchanged.

Comment: One commenter requested that CMS reevaluate the APC assignments for CPT codes 95873 and 95874 when data become available. The commenter believed that it would be appropriate to assign the codes to two different payment levels based on their different resource requirements, but the commenter understood the CMS decision to assign them both to one APC pending data development.

Response: We appreciate the commenter's request, and we will reevaluate the assignment for both of the new codes for the CY 2008 update to the OPPS.

After carefully considering the public comment received, we are finalizing our proposal to assign CPT codes 95873 and 95874 to APC 0215 for CY 2007, without modification.

e. Pathology Services (APC 0344)

In Addendum B of the CY 2007 proposed rule (71 FR 49709), we proposed to assign a payment rate of $49.90 to APC 0344 (Level IV Pathology Services).

Comment: Many commenters considered the proposed payment rate for APC 0344 to be low, especially when compared with the MPFS payment for these same laboratory CPT codes that are assigned to APC 0344. Several commenters indicated that the payment rate of $49.90 was far below the level of payment necessary for performing these tests in the hospital outpatient settings. One commenter cautioned that the cost differential between the hospital OPPS and the MPFS would result in a site-of-service differential. The commenter submitted a table showing differences in payments between the OPPS and the MPFS. The commenter believed that the payment levels for these laboratory services should be the same as or equal under both Medicare payment systems. The commenter asked that CMS establish payment equity for the same service furnished in these respective settings. Several commenters urged CMS to review the payment rate for APC 0344, and assign a payment rate that reflects the complexity and resource costs associated with providing these services.

Response: The statutory method for calculating payment for physicians' practice expenses under the MPFS differs from the general statutory method we use for establishing payment rates in the hospital outpatient setting. Consequently, the application of the different methodologies results in different payment amounts in the two settings.

Payment for services assigned to APC 0344 for CY 2007 will be made based upon the median cost of the APC, established according to the standard OPPS methodology from CY 2005 hospital outpatient claims. The median costs of individual services assigned to APC 0344 do not violate the 2 times rule. The claims data used to establish the APC median cost are stable and robust, and the APC is appropriately structured to include only those procedures with common clinical and resource features.

After carefully considering the public comments received, we are finalizing the APC 0344 structure as proposed without modification. The final CY 2007 median cost of APC 0344 is $48.44, upon which its payment rate is based.

IV. OPPS Payment Changes for Devices

A. Treatment of Device-Dependent APCs

1. Background

Device-dependent APCs are populated by HCPCS codes that usually, but not always, require that a device be implanted or used to perform the procedure. For the CY 2002 OPPS, we used external data, in part, to establish the device-dependent APC medians used for weight setting. At that time, many devices were eligible for pass-through payment. For the CY 2002 OPPS, we estimated that the total amount of pass-through payments would far exceed the limit imposed by statute. To reduce the amount of a pro rata adjustment to all pass-through Start Printed Page 68064items, we packaged 75 percent of the cost of the devices, using external data furnished by commenters on the August 24, 2001 proposed rule and information furnished on applications for pass-through payment, into the median costs for the device-dependent APCs associated with these pass-through devices. The remaining 25 percent of the cost was considered to be pass-through payment.

In the CY 2003 OPPS, we determined APC medians for device-dependent APCs using a three-pronged approach. First, we used only claims with device codes on the claim to set the medians for these APCs. Second, we used external data, in part, to set the medians for selected device-dependent APCs by blending that external data with claims data to establish the APC medians. Finally, we also adjusted the median for any APC (whether device-dependent or not) that declined more than 15 percent. In addition, in the CY 2003 OPPS we deleted the device codes (“C” codes) from the HCPCS file because we believed that hospitals would include the charges for the devices on their claims, notwithstanding the absence of specific codes for devices used.

In the CY 2004 OPPS, we used only claims containing device codes to set the medians for device-dependent APCs and again used external data in a 50/50 blend with claims data to adjust medians for a few device-dependent codes when it appeared that the adjustments were important to ensure access to care. However, hospital device code reporting was optional.

In the CY 2005 OPPS, which was based on CY 2003 claims data, there were no device codes on the claims and, therefore, we could not use device-coded claims in median calculations as a proxy for completeness of the coding and charges on the claims. For the CY 2005 OPPS, we adjusted device-dependent APC medians for those device-dependent APCs for which the CY 2005 OPPS payment median was less than 95 percent of the CY 2004 OPPS payment median. In these cases, the CY 2005 OPPS payment median was adjusted to 95 percent of the CY 2004 OPPS payment median. We also reinstated the device codes and made the use of the device codes mandatory where an appropriate code exists to describe a device utilized in a procedure. In addition, we implemented HCPCS code edits to facilitate complete reporting of the charges for the devices used in the procedures assigned to the device-dependent APCs.

In the CY 2006 OPPS, which was based on CY 2004 claims data, we set the median costs for device-dependent APCs for CY 2006 at the highest of: (1) The median cost of all single bills; (2) the median cost calculated using only claims that contained pertinent device codes and for which the device cost is greater than $1; or (3) 90 percent of the payment median that was used to set the CY 2005 payment rates. We set 90 percent of the CY 2005 payment median as a floor rather than 85 percent as proposed, in consideration of public comments that stated that a 15-percent reduction from the CY 2005 payment median was too large of a transitional step. We noted in our CY 2006 proposed rule that we viewed our proposed 85 percent payment adjustment as a transitional step from the adjusted medians of past years to the use of unadjusted medians based solely on hospital claims data with device codes in future years (70 FR 42714). We also incorporated, as part of our CY 2006 methodology, the recommendation of commenters to base payment on medians that were calculated using only claims that passed the device edits. As stated in the CY 2006 OPPS final rule with comment period (70 FR 68620), we believed that this policy provided a reasonable transition to full use of claims data in CY 2007, which would include device coding and device editing, while better moderating the amount of decline from the CY 2005 OPPS payment rates.

2. CY 2007 Payment Policy

For CY 2007, we proposed to base the device-dependent APC medians on CY 2005 claims, the most current data available. As stated earlier, in CY 2005 we reinstated the use of device codes and made the reporting of device codes mandatory where an appropriate code exists to describe a device utilized. In CY 2005, we also implemented HCPCS code edits to facilitate complete reporting of the charges for the devices used in the procedures assigned to the device-dependent APCs. We implemented the first set of device edits on April 1, 2005, for those APCs for which the CY 2005 payment rate was based on an adjusted median cost. We continued to take public comment on the remaining device edits after April 1, 2005, and implemented device edits for the remaining device-dependent APCs on October 1, 2005. Subsequent to the implementation of the device edits, we received public comments that caused us to remove the requirement for edits for several APCs on the basis that the services in them do not always require the use of a device, or there may be no suitable device codes available for reporting all devices that may be used to perform the procedures.

For example, we removed the requirement for device codes for APC 0080 (Diagnostic Cardiac Catheterization) based on the information provided by hospitals that the codes assigned to this APC do not always require a device for which there is an appropriate HCPCS code. Therefore, we no longer consider this APC to be device-dependent and have removed it from the list of device-dependent APCs. In the case of some procedures assigned to other device-dependent APCs, where we determined that no device was required to provide a particular service or where there were no HCPCS codes that described all devices that could be used to furnish the service, we removed the requirement for a device code for the individual procedure code but retained the device requirement for other procedure codes assigned to that device-dependent APC.

At its February 2006 meeting, the APC Panel recommended that CMS consider calculating the median costs for APCs 0107 (Insertion of Cardioverter Defibrillator) and 0108 (Insertion/Replacement/Repair of Cardioverter-Defibrillator Leads) by bypassing the line-item costs of CPT code 33241 (Subcutaneous removal of single or dual chamber pacing cardioverter-defibrillator pulse generator) and packaging the line item-costs of CPT codes 93640 (Electrophysiological evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement) and 93641 (Electrophysiological evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator) when these codes, separately or in combination, are reported on the same claim with HCPCS codes G0297 (Insertion of single chamber pacing cardioverter defibrillator pulse generator), G0298 (Insertion of dual chamber pacing cardioverter defibrillator pulse generator), G0299 ( Insertion or repositioning of electrode lead for single chamber pacing cardioverter defibrillator and insertion of pulse generator), and G0300 (Insertion or repositioning of electrode lead(s) for dual chamber pacing cardioverter defibrillator and insertion Start Printed Page 68065of pulse generator), which are assigned to APCs 0107 and 0108. The APC Panel recommended bypassing the line-item costs for CPT code 33241 because members believed that when a pacing cardioverter-defibrillator (ICD) pulse generator removal is performed in the same operative session as the insertion of a new pulse generator described by a procedure code assigned to APC 0107 or APC 0108, the packaging on the claim is appropriately assigned to the procedure code in APC 0107 or APC 0108. Moreover, CPT codes 93640 and 93641 may only be correctly coded when the electrophysiologic evaluation of ICD leads is performed at the time of initial implantation or replacement of an ICD pulse generator and/or leads, with or without testing of the pulse generator. Thus, the APC Panel expected that the costs of the evaluations of the ICD leads (CPT codes 93640 and 93641) could be appropriately packaged with the procedure codes that describe the insertion of ICD generators, which are assigned to APCs 0107 and 0108, or the insertion of ICD leads assigned to APCs 0106 (Insertion/Replacement/Repair of Pacemaker and/or Electrodes), 0108, and 0418 (Insertion of Left Ventricular Pacing Elect). Because APCs 0107 and 0108 have typically had very few single bills on which the medians have been based, and because the APC Panel indicated that it believed that we could use many more claims if we bypassed CPT code 33241 and packaged CPT codes 93640 and 93641, we calculated median costs for APCs 0107 and 0108 using these rules. We excluded claims that did not meet the device edits, and we also excluded token claims.

The effect of packaging CPT codes 93640 and 93641 into claims that both passed the device edits and contained no token charges for devices were shown in Table 19 of the CY 2007 OPPS proposed rule (71 FR 49573) and below. This affected APCs 0106, 0107, 0108, and 0418. Bypassing the line-item cost of CPT code 33241 could not be done for all claims on which this CPT code was reported because there are clinical circumstances in which the ICD pulse generator is removed and no new device is implanted. Therefore, the APC assignment of CPT code 33241 and the payment for that code need to reflect the packaging associated with the procedure when it is performed alone. Because of this problem with assigning packaging in all of the circumstances in which the procedure may be reported, we decided against proposing to bypass CPT code 33241, either in general for all procedures or selectively, when it is reported with the procedures in APCs 0107 and 0108.

However, CPT codes 93640 and 93641 are always performed during an operative procedure for ICD initial implantation or replacement or with implantation, revision or replacement of leads, and, therefore, we believed that it would be appropriate to package them into the surgical procedure with which they are performed. Moreover, as a result of the descriptors of the lead evaluation CPT codes, they should never be billed as single procedure claims, and packaging them would also resolve the problem of setting their payment rates in part on the basis of claims that reflect erroneous coding. As we noted in the CY 2007 proposed rule, packaging the costs of intraoperative electrophysiologic testing of the ICD leads yielded many more single bills on which to set median costs and also increased the median costs for APCs 0106, 0107, 0108, and 0418. Therefore, we proposed to package CPT codes 93640 and 93641 for CY 2007.

Furthermore, the APC Panel, at its August 2006 meeting, recommended that CMS use readily available external data to validate the costs derived from claims data. While CMS reviews all information that comes to our attention, we have not systematically used external data to validate the median costs derived from our claims data, because external data are typically furnished by parties with special interest in a particular item or service. Therefore, it is of limited usefulness in determining the relative cost of all items and services paid under the OPPS. In a system of relative weights, it is the relativity of the costs of services to one another, as derived from a standardized system that uses standardized inputs and a consistent methodology, that is the foundation of the system. The relationship between the actual acquisition cost of a particular item or service compared to the relative cost derived from the standard system for a single item or service is of little value.

For the proposed rule, we calculated the median cost for device-dependent APCs using two different sets of claims. We first calculated a median cost using all single procedure claims for the procedure codes in those APCs. We also calculated a second median cost using only claims that contain allowed device codes and also for which charges for all device codes were in excess of $1.00 (nontoken charge device claims). We excluded claims for which the charge for a device was less than $1.01, in part, to recognize hospital charging practices due to a recall of cardioverter defibrillator and pacemaker pulse generators in CY 2005 for which the manufacturers provided replacement devices without cost to the beneficiary or hospital. We also found that there were other devices for which the charge was less than $1.01, and we removed those claims also.

As expected, the median costs calculated using all single procedure bills, including both bills that lacked appropriate device codes (where there are edits) and bills with token charges for devices, were in many cases less than the medians calculated using only claims that contained appropriate device codes without token charges for the devices. In some cases, the medians were significantly different when claims either without device codes or which had only token device charges were removed. In the CY 2007 proposed rule, we noted that we believed that the claims that reflected the best estimated costs for these APCs, including the costs of the devices, were those claims that contain appropriate device codes without token charges for devices. (See section IV.A.4. below for our discussion of payments when the hospital incurs no cost for the principal device required for the service.)

Therefore, we proposed to base the payment rates for CY 2007 for these device-dependent APCs on median costs calculated using claims with appropriate device codes with no token charges for devices reported on the claim. We did not believe that adjustment of these median costs was necessary to provide adequate payment for these services, and, therefore, we did not propose to adjust the median costs for these APCs to moderate any decreases in medians from CY 2006 to CY 2007. However, we noted in the proposed rule that, notwithstanding the device edits, it may continue to be necessary for purposes of median cost calculations to remove claims that do not contain devices because it is likely that there would be incidental occurrences of interrupted procedures in which a device is not used and does not appear on the claim. (The interrupted procedure modifier nullifies the device edit.) Moreover, we noted that there are likely to continue to be incidental occurrences of token charges for devices as a result of devices that are replaced without cost by the manufacturer. However, each of these circumstances could cause the procedure code median cost to underrepresent the cost of the complete procedure, including the device cost, where the hospital purchases the device.

Therefore, we proposed that use of claims that met the device edits and that Start Printed Page 68066did not contain token charges for devices were the appropriate claims to use to set the median costs for the device-dependent APCs, ensuring that the costs of the principal devices were included in the APC medians. In addition, we proposed that, with our proposed changes to the OPPS packaging status of two codes for electrophysiologic evaluation of ICD leads, no special payment policies would be needed to establish payment rates that correctly reflect the relative costs of these procedures to other procedures paid under the OPPS.

We received a number of public comments concerning our CY 2007 proposed payment policies for device-dependent APCs.

Comment: The commenters supported limiting the set of claims used to calculate median costs for device-dependent APCs to claims that passed the device edits and did not contain device charges less than $1.01 to calculate median costs. In addition, some commenters asked CMS to remove claims with residual charges in cases in which recalled devices were replaced by upgraded devices or a different type of device, as was done when we removed token charge claims, so that the full cost of the device would be wholly represented in the procedure claims used for ratesetting. Several commenters objected to the proposed payment rates on the basis that hospitals report the units and charges for devices incorrectly, leading to incomplete and inaccurate claims data. They also believed that the CMS methodology of applying CCRs to charges for device-intensive services results in median costs that do not reflect the true relative costs of those services. They believed that hospitals do not mark up their charges for high cost items sufficiently to result in the actual cost of the item, a phenomenon generally known as “charge compression.” The commenters stated that hospitals are inhibited by market and other forces from charging at a level necessary for the application of the CCR to result in an accurate estimate of the cost of the device. Some commenters offered specific statistical strategies for calculation of adjustment factors that could be applied to the charges for devices to overcome the effects of charge compression. The commenters urged CMS to examine these strategies for their potential application to calculation of median costs and to use the charge compression analysis currently underway for Medicare inpatient billings to initiate a similar analysis for Medicare outpatient hospital payments. They indicated that the proposed payment rates for device-dependent APCs would set payments at such a low level that hospitals were likely to cease furnishing these services so that beneficiaries would no longer have access to needed care. The commenters urged CMS to use external data in place of median costs derived from claims data and to protect all such external data used for ratesetting from public disclosure.

Response: We continue to believe that it is appropriate to calculate the median costs to be used for establishing the payment rates in CY 2007 for device-dependent APCs using only claims that do not contain token charges for devices and that contain the devices that are appropriate for the procedure code, where there are HCPCS codes for such devices. We proposed to exclude all claims containing token charges because there were a number of actions in CY 2005 (the year of claims being used for the CY 2007 OPPS update) that caused hospitals to replace devices that they received without cost from manufacturers, and we advised hospitals to report a token charge for these devices. We will reassess whether exclusion of token charges is necessary for future years because, effective January 1, 2006, devices furnished without cost to the provider will be identified with modifier “FB” and exclusion of claims with token charges may no longer be necessary. We proposed to exclude claims that did not contain appropriate devices, as defined by the device edits on the CMS Web site, to maximize the likelihood that we would be basing the median costs for device-dependent APCs on claims that contained the full charge for the service, including the device. However, we did not exclude claims that contained residual charges for upgrades of replaced devices for which hospitals received credits from manufacturers because it was not possible to identify them systematically. Moreover, because we are calculating a median cost and commenters inform us that upgraded devices represent only 10 to 15 percent of cases in which devices are replaced without cost or with credit for the replaced device, we believe that those claims would have minimal influence on the calculation of the device-dependent APC median cost used for ratesetting. By basing weights on the median cost where the median is the 50th percentile of the array, a relatively small number of unusually low values (as would likely be represented by 10 to 15 percent of a relatively small number of devices replaced without any or full cost) is not likely to significantly affect the median cost. We recognize that the use of the hospital's CCR, even at the departmental level, results in computed costs and relative weights that may be more or less than the actual costs for items in specific cases. We believe that this average is appropriate and inherent in PPS. One of the principles behind the use of median costs for weight setting in a budget neutral payment system like the OPPS is to determine the appropriate relativity in resource use among services, thus allowing fair and equitable distribution of payment among hospitals based on their mix of services provided to Medicare beneficiaries. The median costs are not intended to represent the actual acquisition costs of the services being furnished. They are estimated relative costs that are converted to relative weights, scaled for budget neutrality and then multiplied by a conversion factor to derive a payment under a PPS and are not intended to pay reasonable costs. For this reason, we believe that it is not appropriate to use external pricing information in place of the costs derived from the claims and Medicare cost report data, because we believe that to do so would distort the relativity that is so important to the system's integrity. Similarly, we do not believe that it is appropriate to remove specific claims from contributing to ratesetting if the hospital charge for a particular item does not exceed an established threshold.

However, we recognize that there may be value in exploring the extent to which the estimated relative costs derived from claims and cost report data deviate so substantially from acquisition costs that payment adjustments may be appropriate. Therefore, we are interested in further studying the analytic technique suggested in the comments that would involve the use of a regression analysis to identify adjustments that could be made to the CCRs to account for charge compression. We note that the regression model furnished with some comments was only applied to expensive medical supplies and devices. It was not applied uniformly to develop potential adjustments that could be made to costs and charges across all revenue codes and cost centers that could potentially be subject to charge compression. If such a model were to be applied in the OPPS, we believe further analysis would have to be undertaken to determine whether it should apply to all costs and cost centers. At this time, we intend to study whether a rigorous model could provide a payment adjustment for charge compression to the extent it exists. Start Printed Page 68067

We recognize that the issues the commenters raise regarding charge compression apply both to the OPPS weight setting and to the setting of the DRG weights that are an important determinant of payment under the IPPS for inpatient hospital services. Accordingly, CMS has awarded a 1-year contract to RTI International to study methods of improving estimates of the cost of Medicare inpatient hospital discharges used in constructing the DRG relative weights. The RTI contract will focus on methods of improving the accuracy of the adjustment of charges to cost to account for the fact that hospitals tend to mark up high cost items to a lesser extent than they mark up low cost items, the phenomenon known as charge compression. The study will also examine how charge compression interacts with other variables in the construction of the DRG relative weights, such as the number of cost centers included and whether hospital-specific relative values are used. To the extent that we find charge compression exists, we will further study potential models that could adjust for it so we might develop a more accurate system of cost-based weights to better reflect the relative costs of the different types of services provided under the OPPS. We plan to fully involve appropriate stakeholders in future analysis of this issue to the extent feasible. Before implementing such an adjustment, we would thoroughly describe our analysis and a potential proposed adjustment as part of the OPPS rulemaking process. Further, we intend to use the charge compression study that we will conduct over the next year as an opportunity to better understand the costs of medical devices.

With regard to the comment that providers are ceasing to provide services that require devices, we have no data that causes us to believe that there is a problem with access to care. In fact, the volume and intensity of OPPS services are growing significantly each year. As we indicated in section XIX. of this final rule with comment period, Medicare program payment under the OPPS is expected to reach $32.54 billion in CY 2007, an increase of approximately 9 percent from the projected program payment of $29.809 billion in CY 2006.

Comment: A number of commenters urged CMS to make adjustments to the CY 2007 payment rates for device-dependent APCs to account for charge compression. Specifically, some commenters recommended that CMS set the APC payment rates based on the higher of the median cost calculated using only claims that contain appropriate devices and do not contain token charges for devices or 90 percent of the CY 2006 payment median because to do otherwise would result in discontinuation of some services that require high cost devices. Other commenters urged CMS to set the median cost at no less than 100 percent of the CY 2006 median cost plus the market basket update for CY 2007. Some commenters believed CMS should use only claims on which the charges for their devices equaled or exceeded minimum thresholds that would be set based on amounts they specified. In several cases, the commenters asked that CMS do this due to the billing of residual charges for upgraded devices that replaced recalled devices. In other cases, they recommended thresholds because they believed that hospital charges for devices were too low, thereby resulting in inadequate APC median costs for establishing the CY 2007 payment rates for device-dependent procedures and their packaged devices.

Response: We do not believe that it is necessary or appropriate to set the median cost for these device-dependent APCs at 100 percent of the CY 2006 payment median plus the update factor or at 90 percent of the CY 2006 payment median, or to otherwise override the estimated median costs derived from the claims process proposed, using only claims that contained device codes where appropriate and that did not contain token charges. Because the devices that are required for many of these services came off pass-through payment in CY 2003, we have implemented device edits to maximize the likelihood that the charges for the devices are included on the claim. Over the past several years, we provided for adjustments to the median costs of device-dependent APCs where the cost data for the OPPS update resulted in a decline in the median from one year to the next. We indicated in the CY 2006 final rule (70 FR 68620) that we fully expected to be able to transition to full use of the claims data without adjustment for CY 2007. We see no reason why we should limit the decrease in CY 2007 median cost for those APCs for which the median cost declines compared to the adjusted CY 2006 payment median cost. The nature of a payment system that is based on relative weights is that the weights vary from year to year. Any change in the median cost for an APC, whether one with a high device cost or not, is a function of many complex factors, including, but not limited to, the extent to which hospitals increase charges for some items and services at a different rate than charges for other items and services. As such, the median cost of any particular item or service is largely a function of both its costs and the various charging practices of the hospitals that bill the services. Hospitals have now had 6 years experience with the OPPS, 4 of which were after the expiration of pass-through payments for most devices. We believe that hospitals make thoughtful decisions regarding how they want to report and charge for device-dependent procedures in the context of the effects of those decisions on their payments by Medicare and other payers.

Comment: Some commenters objected to the application of the wage index to the payment for device-dependent APCs. They argued that it creates inequities for hospitals that have low wage indices, due to the application of the wage adjustment to 60 percent of the APC rate, even though the cost of the device is often much more than 60 percent of the APC payment and the device costs are the same regardless of the location of the facility. The commenters objected to hospitals in high cost areas receiving a premium for providing these service, and hospitals in low cost areas receiving what they viewed as a payment penalty for furnishing these services. The commenters asked that the wage index be applied only to 20 percent, rather than the current 60 percent, of the payment for certain device-dependent APCs, specifically 0039, 0107, 0108, 0222, 0224, 0225, 0226, 0227, 0315, 0418, 0654, 0655, and 0656.

Response: The immediate effect of changing the application of the wage index from 60 percent to 20 percent for these APCs is likely to lower payments to hospitals in high cost areas, which we believe likely provide the higher volumes of these services, and to raise payments in low cost areas that likely furnish fewer services. Therefore, we believe that such a change would actually result in lower overall OPPS payment for the procedures. Moreover, any such suggested change could not be done in isolation. At the beginning of the OPPS, we performed a regression analysis resulting in a determination to wage adjust 60 percent of the payment for each APC. This analysis examined the extent to which the body of costs for services furnished in the outpatient department was split between wage and nonwage costs. We determined that 60 percent is an average across all service types, many of which have significant labor costs (for example, visits, drug administration services, and diagnostic tests). We reaffirmed the appropriateness of applying the wage Start Printed Page 68068index to 60 percent of the APC payment during our development of the CY 2006 OPPS (70 FR 68533). By definition, as an average across all services, a standard wage adjustment could not be linked to specific services, particularly the least expensive and most expensive services. To change the application of the wage index for certain device-dependent APCs as commenters request would require reassessing the application of the wage index to all services. In the CY 2006 OPPS final rule, we committed to assessing the effects of the wage index on the device-dependent APCs. We are continuing our efforts in this area.

Comment: Some commenters fully supported packaging CPT codes 93640 (Electrophysiological evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation) and 93641 (Electrophysiological evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation; with testing of single or dual chamber cardioverter defibrillator) because this approach greatly increased the number of single bills that were available for calculating the median costs of APCs 0107 and 0108. Other commenters objected to the packaging of these CPT codes where they appeared on a claim unless the claim also contained a HCPCS code assigned to APCs 0107, 0108, and 0106. Some commenters also objected to packaging 93640 and 93641 into services assigned to APC 0418 because they believed that the packaged services were not performed at the time that procedures in APC 0418 were performed. They were concerned that packaging these testing codes inappropriately raised the median cost of APC 0418.

Response: We continue to believe that the costs of CPT codes 93640 and 93641 are appropriately packaged because they are performed only during the course of identifiable surgical procedures. Under the OPPS data development process, the cost of a packaged HCPCS code on a claim is added to the cost of the single major procedure code that is reported on the same claim, along with other packaged costs also on the claim. In that manner, separate payment for the procedure provides payment for the packaged HCPCS code as well. Because of the enormous number of HCPCS codes, it is not practical to include logic that specifies that a particular HCPCS code is packaged with specified services but not with others. We rely upon hospitals to correctly code the claims they report to Medicare because they have significant incentives to do so (such as, payment and audit concerns).

After carefully considering the public comments received, we are finalizing our proposed payment policies for device-dependent APCs for CY 2007. The CY 2007 payment rates for device-dependent APCs are based on their median costs calculated from CY 2005 nontoken claims that passed the device edits, without application of a maximum payment reduction floor in comparison with CY 2006 payment medians. Discussions of HCPCS code and APC-specific issues for device-dependent APCs are found in section III.D of this preamble, where other APC-specific policies are also discussed.

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3. Devices Billed in the Absence of an Appropriate Procedure Code

As we discussed in the proposed rule (71 FR 49573), in the course of examining claims data for creation of the payment rates for the CY 2007 OPPS proposed rule, we identified circumstances in which hospitals billed a device code but failed to also bill any procedure code with which the device could be used correctly. These errors in billing have led to the costs of the device being packaged with an incorrect procedure code and also have caused the hospital to be paid incorrectly for the