Federal Register: July 20, 2009 (Volume 74, Number 137)
DOCID: fr20jy09-19 FR Doc E9-15882
DEPARTMENT OF HEALTH AND HUMAN SERVICES
United States Institute of Peace
CFR Citation: 42 CFR Parts 410, 416, and 419
RIN ID: RIN 0938-AP41
CMS ID: [CMS-1414-P]
NOTICE: Part II
DOCID: fr20jy09-19
DOCUMENT ACTION: Proposed rule.
SUBJECT CATEGORY:
Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates
DATES: To be assured consideration, comments on all sections of this proposed rule must be received at one of the addresses provided in the ADDRESSES section no later than 5 p.m. EST on August 31, 2009.
DOCUMENT SUMMARY:
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed 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 would be applicable to services furnished on or after January 1, 2010.
In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other pertinent ratesetting information for the CY 2010 ASC payment system. These proposed changes would be applicable to services furnished on or after January 1, 2010.
SUMMARY:
Health and Human Services Department, Centers for Medicare & Medicaid Services
SUPPLEMENTAL INFORMATION
Submitting Comments: We welcome comments from the public on all issues set forth in this proposed rule to assist us in fully considering issues and developing policies. You can assist us by referencing file code CMS1414P for all issues on which you wish to comment.
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http:// www.regulations.gov. Follow the search instructions on that Web site to view public comments.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, on Monday through Friday of each week from 8:30 a.m. to 4 p.m. EST. To schedule an appointment to view public comments, phone 18007433951.
Electronic Access
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Alphabetical List of Acronyms Appearing in This Proposed Rule ACEP American College of Emergency Physicians
AHA American Hospital Association
AHIMA American Health Information Management Association
AMA American Medical Association
AMP Average manufacturer price
AOA American Osteopathic Association
APC Ambulatory payment classification
ASC Ambulatory Surgical Center
ASP Average sales price
[[Page 35233]]
AWP Average wholesale price
BBA Balanced Budget Act of 1997, Public Law 10533
BBRA Medicare, Medicaid, and SCHIP [State Children's Health
Insurance Program] Balanced Budget Refinement Act of 1999, Public Law 106113
BCA Blue Cross Association
BCBSA Blue Cross and Blue Shield Association
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, Public Law 106554
CAH Critical access hospital
CAP Competitive Acquisition Program
CBSA CoreBased Statistical Area
CCR Costtocharge ratio
CERT Comprehensive Error Rate Testing
CKD Chronic kidney disease
CMHC Community mental health center
CMS Centers for Medicare & Medicaid Services
CORF Comprehensive outpatient rehabilitation facility
CPT [Physicians] Current Procedural Terminology, Fourth Edition, 2009, copyrighted by the American Medical Association
CR Cardiac rehabilitation
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, Public Law 109171
DSH Disproportionate share hospital
EACH Essential Access Community Hospital
E/M Evaluation and management
EPO Erythropoietin
ESRD Endstage renal disease
FACA Federal Advisory Committee Act, Public Law 92463
FAR Federal Acquisition Regulations
FDA Food and Drug Administration
FFS Feeforservice
FSS Federal Supply Schedule
FTE Fulltime equivalent
FY Federal fiscal year
GAO Government Accountability Office
GME Graduate medical education
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, Public Law 104191
HOPD Hospital outpatient department
HOP QDRP Hospital Outpatient Quality Data Reporting Program
ICD9CM International Classification of Diseases, Ninth Edition, Clinical Modification
ICR Intensive cardiac rehabilitation
IDE Investigational device exemption
IME Indirect medical education
I/OCE Integrated Outpatient Code Editor
IOL Intraocular lens
IPPS [Hospital] Inpatient prospective payment system
IVIG Intravenous immune globulin
KDE Kidney disease education
MAC Medicare Administrative Contractors
MedPAC Medicare Payment Advisory Commission
MDH Medicaredependent, small rural hospital
MIEATRHCA Medicare Improvements and Extension Act under Division B,
Title I of the Tax Relief Health Care Act of 2006, Public Law 109 432
MIPPA Medicare Improvements for Patients and Providers Act of 2008, Public Law 110275
MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108173
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007, Public Law 110173
MPFS Medicare Physician Fee Schedule
MSA Metropolitan Statistical Area
NCCI National Correct Coding Initiative
NCD National Coverage Determination
NTIOL New technology intraocular lens
OIG [HHS] Office of the Inspector General
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
PR Pulmonary rehabilitation
PRA Paperwork Reduction Act
QAPI Quality Assessment and Performance Improvement
QIO Quality Improvement Organization
RFA Regulatory Flexibility Act
RHQDAPU Reporting Hospital Quality Data for Annual Payment Update [Program]
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, Public Law 97248
TOPS Transitional outpatient payments
USPDI United States Pharmacopoeia Drug Information
WAC Wholesale acquisition cost
In this document, we address two payment systems under the Medicare
program: The hospital outpatient prospective payment system (OPPS) and
the revised ambulatory surgical center (ASC) payment system. The
provisions relating to the OPPS are included in sections I. through
XIV., and XVI. through XXI. of this proposed rule and in Addenda A, B,
C (Addendum C is available on the Internet only; we refer readers to
section XVIII.A. of this proposed rule), D1, D2, E, L, and M to this
proposed rule. The provisions related to the revised ASC payment system
are included in sections XV., XVI., and XVIII. through XXI. of this
proposed rule and in Addenda AA, BB, DD1, DD2, and EE to this proposed
rule. (Addendum EE is available on the Internet only; we refer readers to section XVIII.B. of this proposed rule.)
Table of Contents
I. Background and Summary of the CY 2010 OPPS/ASC Proposed Rule
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. Summary of the Major Contents of This Proposed Rule
1. Proposed Updates Affecting OPPS Payments
2. Proposed OPPS Ambulatory Payment Classification (APC) Group Policies
3. Proposed OPPS Payment for Devices
4. Proposed OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
5. Proposed Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
6. Proposed OPPS Payment for Brachytherapy Sources
7. Proposed OPPS Payment for Drug Administration Services
8. Proposed OPPS Payment for Hospital Outpatient Visits
9. Proposed Payment for Partial Hospitalization Services
10. Proposed Procedures That Will Be Paid Only as Inpatient Services
11. Proposed OPPS Nonrecurring Technical and Policy Clarifications
12. Proposed OPPS Payment Status and Comment Indicators
13. OPPS Policy and Payment Recommendations
14. Proposed Update of the Revised Ambulatory Surgical Center (ASC) Payment System
15. Reporting Quality Data for Annual Payment Rate Updates
16. HealthcareAssociated Conditions
17. Regulatory Impact Analysis
II. Proposed Updates Affecting OPPS Payments
A. Proposed Recalibration of APC Relative Weights
1. Database Construction
a. Database Source and Methodology
b. Proposed Use of Single and Multiple Procedure Claims
c. Proposed Calculation of CCRs
(1) Development of the CCRs
(2) Charge Compression
2. Proposed Data Development Process and Calculation of Median Costs
a. Claims Preparations
b. Splitting Claims and Creation of ``Pseudo'' Single Claims (1) Splitting Claims
(2) Creation of ``Pseudo'' Single Claims
c. Completion of Claim Records and Median Cost Calculations
d. Proposed Calculation of Single Procedure APC CriteriaBased Median Costs
(1) DeviceDependent APCs
(2) Blood and Blood Products
(3) Single Allergy Tests
(4) Echocardiography Services
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(5) Nuclear Medicine Services
(6) Hyperbaric Oxygen Therapy
(7) Payment for Ancillary Outpatient Services When Patient Expires (CA Modifier)
e. Proposed Calculation of Composite APC CriteriaBased Median Costs
(1) Extended Assessment and Management Composite APCs (APCs 8002 and 8003)
(2) Low Dose Rate (LDR) Prostate Brachytherapy Composite APC (APC 8001)
(3) Cardiac Electrophysiologic Evaluation and Ablation Composite APC (APC 8000)
(4) Mental Health Services Composite APC (APC 0034)
(5) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and 8008)
3. Proposed Calculation of OPPS Scaled Payment Weights
4. Proposed Changes to Packaged Services
a. Background
b. ServiceSpecific Packaging Issues
(1) Package Services Addressed by APC Panel Recommendations (2) Other ServiceSpecific Packaging Issues
B. Proposed Conversion Factor Update
C. Proposed Wage Index Changes
D. Proposed Statewide Average Default CCRs
E. Proposed OPPS Payment to Certain Rural and Other Hospitals
1. Hold Harmless Transitional Payment Changes Made by Public Law 110275 (MIPPA)
2. Proposed Adjustment for Rural SCHs Implemented in CY 2006 Related to Public Law 108173(MMA)
F. Proposed Hospital Outpatient Outlier Payments
1. Background
2. Proposed Outlier Calculation
3. Outlier Reconciliation
G. Proposed Calculation of an Adjusted Medicare Payment from the National Unadjusted Medicare Payment
H. Proposed Beneficiary Copayments
1. Background
2. Proposed Copayment Policy
3. Proposed Calculation of an Adjusted Copayment Amount for an APC Group
III. Proposed OPPS Ambulatory Payment Classification (APC) Group Policies
A. Proposed OPPS Treatment of New CPT and Level II HCPCS Codes
1. Proposed Treatment of New Level II HCPCS Codes and Category I CPT Vaccine Codes and Category III CPT Codes for Which We Are Soliciting Public Comments in This Proposed Rule
2. Proposed Process for New Level II HCPCS Codes and Category I
and III CPT Codes for Which We Will Be Soliciting Public Comments in the CY 2010 OPPS/ASC Final Rule With Comment Period
B. Proposed OPPS ChangesVariations Within APCs
1. Background
2. Application of the 2 Times Rule
3. Proposed Exceptions to the 2 Times Rule
C. New Technology APCs
1. Background
2. Proposed Movement of Procedures From New Technology APCs to Clinical APCs
D. Proposed OPPS/ASC Specific Policies: Insertion of Posterior Spinous Process Distraction Device (APC 0052)
IV. Proposed OPPS Payment for Devices
A. PassThrough Payments for Devices
1. Expiration of Transitional PassThrough Payments for Certain Devices
2. Proposed Provisions for Reducing Transitional PassThrough Payments To Offset Costs Packaged Into APC Groups
a. Background
b. Proposed Policy
B. Proposed Adjustment to OPPS Payment for No Cost/Full Credit and Partial Credit Devices
1. Background
2. Proposed APCs and Devices Subject to the Adjustment Policy V. Proposed OPPS Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals
A. Proposed OPPS Transitional PassThrough Payment for Additional Costs of Drugs, Biologicals, and Radiopharmaceuticals
1. Background
2. Proposed Drugs and Biologicals With Expiring PassThrough Status in CY 2009
3. Proposed Drugs, Biologicals, and Radiopharmaceuticals With New or Continuing PassThrough Status in CY 2010
4. PassThrough Payments for Implantable Biologicals
a. Background
b. Proposed Policy for CY 2010
5. Definition of PassThrough Payment Eligibility Period for New Drugs and Biologicals
6. Proposed Provision for Reducing Transitional PassThrough
Payments for Diagnostic Radiopharmaceuticals and Contrast Agents To Offset Costs Packaged Into APC Groups
a. Background
b. Payment Offset Policy for Diagnostic Radiopharmaceuticals
c. Proposed Payment Offset Policy for Contrast Agents
B. Proposed OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals Without PassThrough Status
1. Background
2. Proposed Criteria for Packaging Payment for Drugs, Biologicals, and Radiopharmaceuticals
a. Background
b. Proposed Cost Threshold for Packaging Payment for HCPCS Codes That Describe Certain Drugs, Nonimplantable Biologicals, and Therapeutic Radiopharmaceuticals (``ThresholdPackaged Drugs'')
c. Proposed Packaging Determination for HCPCS Codes That Describe the Same Drug or Biological But Different Dosages
d. Proposed Packaging of Payment for Diagnostic Radiopharmaceuticals, Contrast Agents, and Implantable Biologicals (``PolicyPackaged'' Drugs and Devices)
3. Proposed Payment for Drugs and Biologicals Without Pass Through Status That Are Not Packaged
a. Proposed Payment for Specified Covered Outpatient Drugs
(SCODs) and Other Separately Payable and Packaged Drugs and Biologicals
b. Proposed Payment Policy
4. Proposed Payment for Blood Clotting Factors
5. Proposed Payment for Therapeutic Radiopharmaceuticals
a. Background
b. Proposed Payment Policy
6. Proposed Payment for NonpassThrough Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes, But Without OPPS Hospital Claims Data
VI. Proposed Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
A. Background
B. Proposed Estimate of PassThrough Spending
VII. Proposed OPPS Payment for Brachytherapy Sources
A. Background
B. Proposed OPPS Payment Policy
VIII. Proposed OPPS Payment for Drug Administration Services
A. Background
B. Proposed Coding and Payment for Drug Administration Services IX. Proposed OPPS Payment for Hospital Outpatient Visits
A. Background
B. Proposed Policies for Hospital Outpatient Visits
1. Clinic Visits: New and Established Patient Visits
2. Emergency Department Visits
3. Visit Reporting Guidelines
X. Proposed Payment for Partial Hospitalization Services
A. Background
B. Proposed PHP APC Update for CY 2010
C. Proposed Separate Threshold for Outlier Payments to CMHCs
XI. Proposed Procedures That Will Be Paid Only as Inpatient Procedures
A. Background
B. Proposed Changes to the Inpatient List
XII. Proposed OPPS Nonrecurring Technical and Policy Changes and Clarifications
A. Kidney Disease Education Services
1. Background
2. Proposed Payment for Services Furnished by Providers of Services Located in a Rural Area
B. Pulmonary Rehabilitation and Cardiac Rehabilitation Services
1. Legislative Changes
2. Proposed Payment for Services Furnished to Hospital Outpatients in a Pulmonary Rehabilitation Program
3. Proposed Payment for Services Furnished to Hospital Outpatients Under a Cardiac Rehabilitation or an Intensive Cardiac Rehabilitation Program
4. Physician Supervision for Pulmonary Rehabilitation, Cardiac Rehabilitation, and Intensive Cardiac Rehabilitation Services
C. Stem Cell Transplants
D. Physician Supervision
1. Background
2. Issues Regarding the Physician Supervision of Hospital Outpatient Services Raised by Hospitals and Other Stakeholders
3. Proposed Policies for Direct Supervision of Hospital and CAH Outpatient Therapeutic Services
[[Page 35235]]
4. Proposed Policies for Direct Supervision of Hospital and CAH Outpatient Diagnostic Services
5. Summary of CY 2010 Physician Supervision Proposals
E. Direct Referral for Observation Services
XIII. Proposed OPPS Payment Status and Comment Indicators
A. Proposed OPPS Payment Status Indicator Definitions
1. Proposed Payment Status Indicators To Designate Services That Are Paid Under the OPPS
2. Proposed Payment Status Indicators To Designate Services That Are Paid Under a Payment System Other Than the OPPS
3. Proposed Payment Status Indicators To Designate Services That Are Not Recognized Under the OPPS But That May Be Recognized by Other Institutional Providers
4. Proposed Payment Status Indicators To Designate Services That Are Not Payable by Medicare on Outpatient Claims
B. Proposed Comment Indicator Definitions
XIV. OPPS Policy and Payment Recommendations
A. MedPAC Recommendations
B. APC Panel Recommendations
C. OIG Recommendations
XV. Proposed Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
1. Legislative Authority for the ASC Payment System
2. Prior Rulemaking
3. Policies Governing Changes to the Lists of Codes and Payment
Rates for ASC Covered Surgical Procedures and Covered Ancillary Services
B. Proposed Treatment of New Codes
1. Proposed Treatment of New Category I and III CPT Codes and Level II HCPCS Codes
2. Proposed Treatment of New Level II HCPCS Codes Implemented in April and July 2009
C. Proposed Update to the List of ASC Covered Surgical Procedures and Covered Ancillary Services
1. Covered Surgical Procedures
a. Proposed Additions to the List of ASC Covered Surgical Procedures
b. Proposed Covered Surgical Procedures Designated as Office Based
(1) Background
(2) Proposed Changes to Covered Surgical Procedures Designated as OfficeBased for CY 2010
c. Covered Surgical Procedures Designated as DeviceIntensive (1) Background
(2) Proposed Changes to List of Covered Surgical Procedures Designated as DeviceIntensive for CY 2010
d. ASC Treatment of Surgical Procedures Proposed for Removal from the OPPS Inpatient List for CY 2010
2. Covered Ancillary Services
D. Proposed ASC Payment for Covered Surgical Procedures and Covered Ancillary Services
1. Proposed Payment for Covered Surgical Procedures
a. Background
b. Proposed Update to ASC Covered Surgical Procedure Payment Rates for CY 2010
c. Proposed Adjustment to ASC Payments for No Cost/Full Credit and Partial Credit Devices
2. Proposed Payment for Covered Ancillary Services
a. Background
b. Proposed Payment for Covered Ancillary Services for CY 2010
E. New Technology Intraocular Lenses (NTIOLs)
1. Background
2. NTIOL Application Process for Payment Adjustment
3. Classes of NTIOLs Approved and New Request for Payment Adjustment
a. Background
b. Requests To Establish New NTIOL Class for CY 2010 and Deadline for Public Comment
4. Proposed Payment Adjustment
5. Proposed ASC Payment for Insertion of IOLs
F. Proposed ASC Payment and Comment Indicators
1. Background
2. Proposed ASC Payment and Comment Indicators
G. ASC Policy and Payment Recommendations
H. Proposed Revision to Terms of Agreements for Hospital Operated ASCs
1. Background
2. Proposed Changes to the Terms of Agreements for ASCs Operated by a Hospital
I. Calculation of the ASC Conversion Factor and ASC Payment Rates
1. Background
2. Proposed Calculation of the ASC Payment Rates
a. Updating the ASC Relative Payment Weights for CY 2010 and Future Years
b. Updating the ASC Conversion Factor
3. Display of Proposed ASC Payment Rates
XVI. Reporting Quality Data for Annual Payment Rate Updates
A. Background
1. Overview
2. Hospital Outpatient Quality Data Reporting Under Section 109(a) of Public Law 109432
3. Reporting ASC Quality Data for Annual Payment Update
4. HOP QDRP Quality Measures for the CY 2009 Payment Determinations
5. HOP QDRP Quality Measures for the CY 2010 Payment Determination
a. Background
b. Maintenance of Technical Specifications for Quality Measures
c. Publication of HOP QDRP Data
B. Proposals Regarding Quality Measures
1. Considerations in Expanding and Updating Quality Measures Under the HOP QRDP Program
2. Retirement of HOP QRDP Quality Measures
3. Proposed HOP QDRP Quality Measures for the CY 2011 Payment Determination
C. Possible Quality Measures Under Consideration for FY 2012 and Subsequent Years
D. Proposed Payment Reduction for Hospitals That Fail To Meet the HOP QDRP Requirements for the CY 2010 Payment Update
1. Background
2. Proposed Reporting Ratio Application and Associated Adjustment Policy for CY 2010
E. Proposed Requirements for HOPD Quality Data Reporting for CY 2011 and Subsequent Years
1. Administrative Requirements
2. Data Collection and Submission Requirements
a. General Data Collection and Submission Requirements
b. Extraordinary Circumstance Extension or Waiver for Reporting Quality Data
3. HOP QDRP Validation Requirements
a. Proposed Data Validation Requirements for CY 2011
b. Proposed Data Validation Approach for CY 2012 and Subsequent Years
c. Additional Data Validation Conditions Under Consideration for CY 2012 and Subsequent Years
F. Proposed 2010 Publication of HOP QDRP Data
G. Proposed HOP QDRP Reconsideration and Appeals Procedures
H. Reporting of ASC Quality Data
I. Electronic Health Records
XVII. HealthcareAssociated Conditions
A. Background
1. Preventable Medical Errors and HospitalAcquired Conditions (HACs) Under the IPPS
2. Expanding the Principles of the IPPS HACs Payment Provision to the OPPS
3. Discussion in the CY 2009 OPPS/ASC Final Rule With Comment Period
B. Public Comments and Recommendations on Issues Regarding HealthcareAssociated Conditions From the Joint IPPS/OPPS Listening Session
C. CY 2010 Approach to HealthcareAssociated Conditions Under the OPPS
XVIII. Files Available to the Public via the Internet
A. Information in Addenda Related to the Proposed CY 2010 Hospital OPPS
B. Information in Addenda Related to the Proposed CY 2010 ASC Payment System
XIX. Collection of Information Requirements
XX. Response to Comments
XXI. 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 Proposed Rule
1. Alternatives Considered
2. Limitation of Our Analysis
3. Estimated Effects of This Proposed Rule on Hospitals
4. Estimated Effects of This Proposed Rule on CMHCs
5. Estimated Effects of This Proposed Rule on Beneficiaries
6. Conclusion
7. Accounting Statement
C. Effects of ASC Payment System Changes in This Proposed Rule
1. Alternatives Considered
2. Limitations of Our Analysis
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3. Estimated Effects of This Proposed Rule on Payments to ASCs
4. Estimated Effects of This Proposed Rule on Beneficiaries
5. Conclusion
6. Accounting Statement
D. Effects of Proposed Requirements for Reporting of Quality Data for Annual Hospital Payment Update
E. Executive Order 12866
Regulation Text
Addenda
Addendum AProposed OPPS APCs for CY 2010
Addendum AAProposed ASC Covered Surgical Procedures for CY 2010
(Including Surgical Procedures for Which Payment Is Packaged) Addendum BProposed OPPS Payment by HCPCS Code for CY 2010
Addendum BBProposed ASC Covered Ancillary Services Integral to
Covered Surgical Procedures for CY 2010 (Including Ancillary Services for Which Payment Is Packaged)
Addendum D1Proposed OPPS Payment Status Indicators for CY 2010 Addendum DD1Proposed ASC Payment Indicators for CY 2010
Addendum D2Proposed OPPS Comment Indicators for CY 2010
Addendum DD2Proposed ASC Comment Indicators for CY 2010
Addendum EProposed HCPCS Codes That Would Be Paid Only as
Inpatient Procedures for CY 2010
Addendum LProposed CY 2010 OPPS OutMigration Adjustment
Addendum MProposed HCPCS Codes for Assignment to Composite APCs for CY 2010
I. Background and Summary of the CY 2010 OPPS/ASC Proposed Rule
A. Legislative and Regulatory Authority for the Hospital Outpatient Prospective Payment System
When the Medicare statute was enacted, Medicare payment for hospital outpatient services was based on hospitalspecific 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 costbased payment methodology with a prospective payment system (PPS). The Balanced Budget Act (BBA) of 1997 (Pub. L. 10533) added section 1833(t) to the Social Security Act (the Act) authorizing implementation of a PPS for hospital outpatient services. 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.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act (BBRA) of 1999 (Pub. L. 106113) made major changes in the hospital outpatient prospective payment system (OPPS). The following Acts made additional changes to the OPPS: the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000 (Pub. L. 106 554); the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108173); the Deficit Reduction Act (DRA) of 2005 (Pub. L. 109171), enacted on February 8, 2006; the Medicare Improvements and Extension Act under Division B of Title I of the Tax Relief and Health Care Act (MIEATRHCA) of 2006 (Pub. L. 109432), enacted on December 20, 2006; the Medicare, Medicaid, and SCHIP Extension Act (MMSEA) of 2007 (Pub. L. 110173), enacted on December 29, 2007; and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 (Pub. L. 110275), enacted on July 15, 2008.
Under the OPPS, we pay for hospital outpatient services on a rate
perservice basis that varies according to the ambulatory payment
classification (APC) group to which the service is assigned. We use the
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 proposed rule. Section
1833(t)(1)(B)(ii) of the Act provides for 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 Public
Law 108173 added provisions for coverage for 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 laborrelated amount and a nonlaborrelated amount. The laborrelated amount is adjusted for area wage differences using the hospital inpatient 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 generally use the median cost of the item or service assigned to an APC group.
For new technology items and services, special payments under the OPPS may be made in one of two ways. Section 1833(t)(6) of the Act provides for temporary additional payments, which we refer to as ``transitional passthrough 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 passthrough 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 passthrough 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 speechlanguage
pathology services, for which payment is made under a fee schedule.
Section 614 of Public Law 108173 amended section 1833(t)(1)(B)(iv) of
the Act to exclude payment for screening and diagnostic mammography
services from the OPPS. The Secretary exercised the authority granted
under the statute to also exclude from the OPPS those services that are
paid under fee schedules or other payment systems. Such excluded services include, for
[[Page 35237]]
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 (CLFS); services for beneficiaries with endstage 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 Sec. 419.22 of the regulations.
Under Sec. 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 that take into account changes in medical practices, changes in technologies, 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 continuing experience with this system. These rules can be viewed on the CMS Web site at: http:// www.cms.hhs.gov/HospitalOutpatientPPS/. We published in the Federal Register on November 18, 2008 the CY 2009 OPPS/ASC final rule with comment period (73 FR 68502). 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 2009 OPPS on the basis of claims data from January 1, 2007, through December 31, 2007, and to implement certain provisions of Public Law 110173 and Public Law 110275. In addition, in that final rule we also responded to public comments received on the provisions of the November 27, 2007 final rule with comment period (72 FR 66580) pertaining to the APC assignment of HCPCS codes identified in Addendum B to that rule with the new interim (``NI'') comment indicator, and to public comments received on the July 18, 2008 OPPS/ASC proposed rule for CY 2009 (73 FR 41416).
Subsequent to publication of the CY 2009 OPPS/ASC final rule with
comment period, we published in the Federal Register on January 26,
2009, a correction notice (74 FR 4343 through 4344) to correct certain
technical errors in the CY 2009 OPPS/ASC final rule with comment period.
D. Advisory Panel on Ambulatory Payment Classification Groups 1. Authority of the APC Panel
Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of Public Law 106113, and redesignated by section 202(a)(2) of Public Law 106113, 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 proposed rule, fulfills these requirements. The APC Panel is not restricted to using data compiled by CMS, and it 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 (currently employed fulltime, not as consultants, in their respective areas of expertise) subject to the OPPS, reviews clinical data and advises CMS about the clinical integrity of the APC groups and their payment weights. The APC Panel is technical in nature, and it is governed by the provisions of the Federal Advisory Committee Act (FACA). Since its initial chartering, the Secretary has renewed the APC Panel's charter four times: on November 1, 2002; on November 1, 2004; on November 21, 2006; and on November 2, 2008. The current charter specifies, 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 designated by the Secretary.
The current APC Panel membership and other information pertaining to the APC Panel, including its charter, Federal Register notices, membership, meeting dates, agenda topics, and meeting reports, can be viewed on the CMS Web site at: http://www.cms.hhs.gov/FACA/05_ AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp#TopOfPage. 3. APC Panel Meetings and Organizational Structure
The APC Panel first met on February 27 through March 1, 2001. Since the initial meeting, the APC Panel has held 15 meetings, with the last meeting taking place on February 18 and 19, 2009. Prior to each meeting, we publish a notice in the Federal Register to announce the meeting and, when necessary, to solicit nominations for APC Panel membership and to announce new members.
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 Visits and 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 Visits and Observation Subcommittee reviews and makes recommendations to the APC Panel on all technical issues pertaining to observation services and hospital outpatient visits paid under the OPPS (for example, APC configurations and APC payment weights). The Packaging Subcommittee studies and makes recommendations on issues pertaining to services that are not separately payable under the OPPS, but whose payments are bundled or packaged into APC payments. Each of these subcommittees was established by a majority vote from the full APC Panel during a scheduled APC Panel meeting, and their continuation as subcommittees was last approved at the February 2009 APC Panel meeting. At that meeting, the APC Panel recommended that the work of these three subcommittees continue, and we accept those recommendations of the APC Panel. All subcommittee recommendations are discussed and voted upon by the full APC Panel. [[Page 35238]]
Discussions of the other recommendations made by the APC Panel at the February 2009 meeting are included in the sections of this proposed rule that are specific to each recommendation. For discussions of earlier APC Panel meetings and recommendations, we refer readers to previously published hospital OPPS/ASC proposed and final rules, the CMS Web site mentioned earlier in this section, and the FACA database at http://fido.gov/facadatabase/public.asp. E. Background and Summary of the CY 2010 OPPS/ASC Proposed Rule
In this proposed rule, we set forth proposed changes to the Medicare hospital OPPS for CY 2010 to implement statutory requirements and changes arising from our continuing experience with the system. In addition, we are setting forth proposed changes to the revised Medicare ASC payment system for CY2010, including proposed updated payment weights and covered surgical ancillary services based on the proposed OPPS update. Finally, we are setting forth proposed quality measures for the Hospital Outpatient Quality Data Reporting Program (HOP QDRP) for reporting quality data for annual payment rate updates for CY 2011 and subsequent calendar years, the requirements for data collection and submission for the annual payment update, and a proposed reduction in the OPPS payment for hospitals that fail to meet the HOP QDRP requirements for the CY 2010 payment update, in accordance with the statutory requirement. These changes would be effective for services furnished on or after January 1, 2010. The following is a summary of the major changes that we are proposing to make:
1. Proposed Updates Affecting OPPS Payments
In section II. of this proposed rule, we set forth
In section III. of this proposed rule, we discuss
3. Proposed OPPS Payment for Devices
In section IV. of this proposed rule, we discuss proposed pass
through payment for specific categories of devices and the proposed
adjustment for devices furnished at no cost or with partial or full credit.
4. Proposed OPPS Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals
In section V. of this proposed rule, we discuss proposed CY 2010
OPPS payment for drugs, biologicals, and radiopharmaceuticals,
including the proposed payment for drugs, biologicals, and radiopharmaceuticals with and without passthrough status.
5. Proposed Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
In section VI. of this proposed rule, we discuss the estimate of CY 2010 OPPS transitional passthrough spending for drugs, biologicals, and devices.
6. Proposed OPPS Payment for Brachytherapy Sources
In section VII. of this proposed rule, we discuss our proposal concerning payment for brachytherapy sources.
7. Proposed OPPS Payment for Drug Administration Services
In section VIII. of this proposed rule, we set forth our proposed policy concerning coding and payment for drug administration services. 8. Proposed OPPS Payment for Hospital Outpatient Visits
In section IX. of this proposed rule, we set forth our proposed policies for the payment of clinic and emergency department visits and critical care services based on claims data.
9. Proposed Payment for Partial Hospitalization Services
In section X. of this proposed rule, we set forth our proposed
payment for partial hospitalization services, including the proposed separate threshold for outlier payments for CMHCs.
10. Proposed Procedures That Will Be Paid Only as Inpatient Procedures
In section XI. of this proposed rule, we discuss the procedures
that we are proposing to remove from the inpatient list and assign to APCs for payment under the OPPS.
11. Proposed OPPS Nonrecurring Technical and Policy Changes and Clarifications
In section XII. of this proposed rule, we set forth our proposals regarding nonrecurring technical issues and provide policy clarifications.
12. Proposed OPPS Payment Status and Comment Indicators
In section XIII. of this proposed rule, we discuss our proposed changes to the definitions of status indicators assigned to APCs and present our proposed comment indicators for the final rule with comment period.
13. OPPS Policy and Payment Recommendations
In section XIV. of this proposed rule, We address recommendations
made by the Medicare Payment Advisory Commission (MedPAC) in its March
2009 report to Congress, by the Office of Inspector General (OIG), and by the APC Panel regarding the OPPS for CY 2010.
14. Proposed Ambulatory Surgical Center (ASC) Payment System
In section XV. of this proposed rule, we discuss the proposed update of the revised ASC payment system covered surgical procedures and covered ancillary services and payment rates for CY 2010. [[Page 35239]]
15. Reporting Quality Data for Annual Payment Rate Updates
In section XVI. of this proposed rule: We discuss the proposed quality measures for reporting hospital outpatient (HOP) quality data for the annual payment update factor for CY 2012 and subsequent calendar years; set forth the requirements for data collection and submission for the annual payment update; and propose a reduction in the OPPS payment for hospitals that fail to meet the HOP Quality Data Reporting Program (QDRP) requirements for CY 2010.
16. HealthcareAssociated Conditions
In section XVII. of this proposed rule, we discuss public responses to a December 2008 CMS public listening session addressing the potential extension of the principle of Medicare not paying more under the IPPS for the care of preventable hospitalacquired conditions experienced by a Medicare beneficiary during a hospital inpatient stay to medical care in other settings that are paid under other Medicare payment systems, including the OPPS, for those healthcareassociated conditions that occur or result from care in those other settings. 17. Regulatory Impact Analysis
In section XXI. of this proposed rule, we set forth an analysis of
the impact the proposed changes would have on affected entities and beneficiaries.
II. Proposed Updates Affecting OPPS Payments
A. Proposed Recalibration of APC Relative Weights
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.
For CY 2010, we are proposing to use the same basic methodology that we described in the April 7, 2000 OPPS final rule with comment period to recalibrate the APC relative payment weights for services furnished on or after January 1, 2010, and before January 1, 2011 (CY 2010). That is, we are proposing to recalibrate the relative payment weights for each APC based on claims and cost report data for hospital outpatient department (HOPD) services. We are proposing to use the most recent available data to construct the database for calculating APC group weights. Therefore, for the purpose of recalibrating the proposed APC relative payment weights for CY 2010, we used approximately 130 million final action claims for hospital outpatient department services furnished on or after January 1, 2008, and before January 1, 2009. (For exact counts of claims used, we refer readers to the claims accounting narrative under supporting documentation for this proposed rule on the CMS Web site at: http://www.cms.hhs.gov/HospitalOutpatientPPS/HORD/.)
Of the 130 million final action claims for services provided in hospital outpatient settings used to calculate the CY 2010 OPPS payment rates for this proposed rule, approximately 100 million claims were 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 100 million claims, approximately 46 million claims were not for services paid under the OPPS or were excluded as not appropriate for use (for example, erroneous costtocharge ratios (CCRs) or no HCPCS codes reported on the claim). From the remaining 54 million claims, we created approximately 91 million single records, of which approximately 61 million were ``pseudo'' single or ``single session'' claims (created from 24 million multiple procedure claims using the process we discuss later in this section). Approximately 622,000 claims were trimmed out on cost or units in excess of +/ 3 standard deviations from the geometric mean, yielding approximately 90 million single bills for median setting. As described in section II.A.2. of this proposed rule, our data development process is designed with the goal of using appropriate cost information in setting the APC relative weights. The bypass process described in section II.A.1.b. of this proposed rule discusses how we develop ``pseudo'' single claims, with the intention of using more appropriate data from the available claims. In some cases, the bypass process allows us to use some portion of the submitted claim for cost estimation purposes, while the remaining information on the claim continues to be unusable. Consistent with the goal of using appropriate information in our data development process, we only use claims (or portions of each claim) that are appropriate for ratesetting purposes. Ultimately, we were able to use for CY 2010 ratesetting some portion of 95 percent of the CY 2008 claims containing services payable under the OPPS.
The proposed APC relative weights and payments for CY 2010 in Addenda A and B to this proposed rule were calculated using claims from CY 2008 that were processed before January 1, 2009, 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. We continue to believe that it is appropriate to use the most current full calendar year claims data and the most recently submitted cost reports to calculate the median costs which we are proposing to convert to relative payment weights for purposes of calculating the CY 2010 payment rates.
b. Proposed Use of Single and Multiple Procedure Claims
For CY 2010, in general, we are proposing to continue to use single procedure claims to set the medians on which the APC relative payment weights would be based, with some exceptions as discussed below in this section. We generally use single procedure claims to set the median costs for APCs because we believe that the OPPS relative weights on which payment rates are based should be derived from the costs of furnishing one procedure and because, in many circumstances, we are unable to ensure that packaged costs can be appropriately allocated across multiple procedures performed on the same date of service.
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 claims for multiple procedures. As we have for
several years, we continued to use date of service stratification and a
list of codes to be bypassed to convert multiple procedure claims to
``pseudo'' single procedure claims. Through 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
were submitted as multiple procedure claims that contained numerous
separately paid procedures reported on the same date on one claim. We
refer to these newly created single procedure claims as ``pseudo''
single claims. The history of our use of a bypass list to generate
``pseudo'' single claims is well documented, most recently in the CY
2009 OPPS/ASC final rule with comment period (73 FR 68512 through [[Page 35240]]
68519). In addition, for CY 2008, we increased packaging and created
the first composite APCs. This also increased the number of bills that
we were able to use for median calculation by enabling us to use claims
that contained multiple major procedures that previously would not have
been usable. Further, for CY 2009, we expanded the composite APC model
to one additional clinical area, multiple imaging services (73 FR 68559
through 68569). We refer readers to section II.A.2.e. of this proposed
rule for discussion of the use of claims to establish median costs for composite APCs.
We are proposing to continue to apply these processes to enable us to use as much claims data as possible for ratesetting for the CY 2010 OPPS. This process enabled us to create, for this proposed rule, approximately 61 million ``pseudo'' single claims, including multiple imaging composite ``single session'' bills (we refer readers to section II.A.2.e.(5) of this proposed rule for further discussion), to add to the approximately 30 million ``natural'' single bills. For this proposed rule, ``pseudo'' single and ``single session'' procedure bills represent 67 percent of all single bills used to calculate median costs.
For CY 2010, we are proposing to bypass 438 HCPCS codes for CY 2010
that are identified in Table 1 of this proposed rule. Since the
inception of the bypass list, we have calculated the percent of
``natural'' single bills that contained packaging for each HCPCS code
and the amount of packaging in each ``natural'' single bill for each
code. We have generally retained the codes on the previous year's
bypass list and used the update year's data (for CY 2010, data
available for the February 2009 APC Panel meeting from CY 2008 claims
processed through September 30, 2008) to determine whether it would be
appropriate to propose to add additional codes to the previous year's
bypass list. For CY 2010, we are proposing to continue to bypass all of
the HCPCS codes on the CY 2009 OPPS bypass list. We also are proposing
to add to the bypass list for CY 2010 all HCPCS codes not on the CY
2009 bypass list that, using both CY 2009 final rule and February 2009
APC Panel data, meet the same previously established empirical criteria
for the bypass list that are summarized below. The entire list proposed
for CY 2010 (including the codes that remain on the bypass list from
prior years) is open to public comment. We assume that the
representation of packaging in the ``natural'' single claims for any
given code is comparable to packaging for that code in the multiple claims. The proposed criteria for the bypass list are:
In addition, we are proposing to continue to include on the bypass list HCPCS codes that CMS medical advisors believe have minimal associated packaging based on their clinical assessment of the complete CY 2010 OPPS proposal. Some of these codes were identified by CMS medical advisors and some were identified in prior years by commenters with specialized knowledge of the services that they requested be added to the bypass list. We also are proposing to continue to include on the bypass list certain HCPCS codes in order to purposefully direct the assignment of packaged costs where codes always appear together and there would otherwise be few single claims available for ratesetting. For example, we have previously discussed our reasoning for adding HCPCS code G0390 (Trauma response team associate with hospital critical care service) and the CPT codes for additional hours of drug administration to the bypass list (73 FR 68513 and 71 FR 68117 through 68118).
As a result of the multiple imaging composite APCs that we established in CY 2009, we note that the program logic for creating ``pseudo'' singles from bypassed codes that are also members of multiple imaging composite APCs changed. When creating the set of ``pseudo'' single claims, claims that contain ``overlap bypass codes,'' that is, those HCPCS codes that are both on the bypass list and are members of the multiple imaging composite APCs, were identified first. These HCPCS codes were then processed to create multiple imaging composite ``single session'' bills, that is, claims containing HCPCS codes from only one imaging family, thus suppressing the initial use of these codes as bypass codes. However, these ``overlap bypass codes'' were retained on the bypass list because, at the end of the ``pseudo'' single processing logic, we reassessed the claims without suppression of the ``overlap bypass codes'' under our longstanding ``pseudo'' single process to determine whether we could convert additional claims to ``pseudo'' single claims. (We refer readers to section II.A.2.b. of this proposed rule for further discussion of the treatment of ``overlap bypass codes.'') This process also created multiple imaging composite ``single session'' bills that could be used for calculating composite APC median costs. ``Overlap bypass codes'' that are members of the proposed multiple imaging composite APCs are identified by asterisks (*) in Table 1 below.
At the February 2009 APC Panel Meeting, the APC Panel recommended that CMS place CPT code 76098 (Radiological examination, surgical specimen) on the bypass list and reassign the code to APC 0260 (Level I Plain Film Except Teeth) in response to a public presentation requesting that CMS makes these changes. Although CPT code 76098 would not be eligible for addition to the bypass list because the frequency and magnitude of packaged costs in its ``natural'' single claims exceed the empirical criteria, the presenter suggested that the ``natural'' single claims represented aberrant billing with inappropriate packaged services and pointed out that the packaged services support the surgical procedures that commonly are also reported on claims for CPT code 76098. The presenter suggested that bypassing CPT code 76098 would properly allocate packaged costs to surgical procedures on these claims, and would increase the number of single claims available for ratesetting for both CPT code 76098 and the associated surgical breast procedures. The APC Panel indicated that the issues raised by the presenter appeared to be consistent with clinical practice and subsequently made the recommendation to bypass CPT code 76098 and reassign the code to APC 0260 based on its revised cost.
Based on the APC Panel's specific recommendation for CPT code
76098, we studied the billing patterns for the code in the ``natural''
single and multiple major claims in the CY 2008 claims data available
for the February 2009 APC Panel. The presenter asserted that CPT code
76098 is commonly billed with surgical breast procedures and our claims data from the multiple procedure
[[Page 35241]]
claims confirm this observation. However, as noted above, there are
also a significant number of ``natural'' single bills in those data
(1,303), and these ``natural'' single claims include packaged services,
such as CPT code 19290 (Preoperative placement of needle localization
wire, breast) and CPT 77032 code (Mammographic guidance for needle
placement, breast (e.g., for wire localization or for injection), each
lesion, radiological supervision and interpretation). We have received
anecdotal information that hospitals may place guidance wires prior to
surgery in the hospital's radiology department and then examine the
surgical specimen in the radiology department after its surgical
removal. This information, along with the number of observed
``natural'' single claims, suggests that the packaged costs might
appropriately be associated with the radiological examination of the
breast specimen. Although bypassing CPT code 76098 would allow for the
creation of more ``pseudo'' single claims for ratesetting, it would
also require the assumption that all packaging on the claim would be
correctly assigned to the remaining major procedure where it exists and
that on ``natural'' single bills no packaging would be appropriately
associated with CPT code 76098. Given the number of ``natural'' single
bills for CPT code 76098 and the significant packaged costs on these
claims, we are not confident that placement on the bypass list is appropriate.
While we are not proposing to place CPT code 76098 on the bypass list, and we want to continue to provide separate payment for this procedure when appropriate, we do believe that CPT code 76098 is generally ancillary and supportive to surgical breast procedures. In CY 2008 we established a group of conditionally packaged codes, called ``Tpackaged codes,'' whose payment is packaged when one or more separately paid surgical procedures with status indicator ``T'' are provided during a hospital encounter. In order to provide separate payment for CPT code 76098 when not provided with a separately payable surgical procedure, and also to recognize its ancillary and supportive nature when it accompanies separately payable procedures, we are proposing to conditionally package CPT code 76098 as a ``Tpackaged code'' for CY 2010, identified with status indicator ``Q2'' in Addendum B to this proposed rule. As a ``Tpackaged code,'' CPT code 76098 would receive separate payment except where it appears with a surgical procedure, in which case its payment would be packaged. Designating CPT 76098 in this way allows the separate payment to appropriately account for the packaged costs that appear on the code's ``natural'' single bills, while also allowing us to use more multiple procedure claims that include both a surgical procedure and CPT code 76098 to set the payment rates for the related surgical procedures. The codespecific median cost of CPT code 76098 is approximately $346, consistent with its CY 2009 assignment to APC 0317 (Level II Miscellaneous Radiology Procedures) which has an APC median cost of approximately $339. In contrast, the median cost of APC 0260, the APC reassignment recommended by the APC Panel, is much lower at approximately $46. Therefore, we are not accepting the APC Panel's recommendation to reassign CPT code 76098. Instead, we are proposing to continue its assignment to APC 0317 for CY 2010 in those cases where CPT code 76098 is separately paid.
Table 1 includes the proposed list of bypass codes for CY 2010.
This list contains bypass codes that are appropriate to claims for
services in CY 2008 and, therefore, includes codes that were deleted
for CY 2009. We retain these deleted bypass codes on the bypass list
because these codes existed in CY 2008, the year of our claims data.
Using these deleted bypass codes for bypass purposes allows us to
potentially create more ``pseudo'' single claims for ratesetting
purposes. ``Overlap bypass codes'' that are members of the proposed
multiple imaging composite APCs are identified by asterisks (*) in Table 1 below.
BILLING CODE 412001P
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BILLING CODE 412001C
c. Proposed Calculation of CCRs
(1) Development of the CCRs
We cal
FOR FURTHER INFORMATION CONTACT
Alberta Dwivedi, (410) 786-0378, Hospital outpatient prospective payment issues.
Dana Burley, (410) 7860378, Ambulatory surgical center issues.
Michele Franklin, (410) 7864533, and Jana Lindquist, (410) 786 4533, Partial hospitalization and community mental health center issues.
James Poyer, (410) 7862261, Reporting of quality data issues.