Federal Register: November 20, 2009 (Volume 74, Number 223)
DOCID: fr20no09-16 FR Doc E9-26499
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Western Area Power Administration
CFR Citation: 42 CFR Parts 410, 416, and 419
RIN ID: RIN 0938-AP41
CMS ID: [CMS-1414-FC]
NOTICE: Part II
DOCID: fr20no09-16
DOCUMENT ACTION: Final rule with comment period.
SUBJECT CATEGORY:
Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates
DATES: Effective Date: The provisions of this rule are effective January 1, 2010.
Comment Period: We will consider comments on the subject areas listed in the SUPPLEMENTARY INFORMATION section of this rule that are received at one of the addresses provided in the ADDRESSES section of this rule no later than 5 p.m. EST on December 29, 2009.
Application Deadline for New Class of New Technology Intraocular Lenses: Request for review of applications for a new class of new technology intraocular lenses must be received by 5 p.m. EST on March 8, 2010.
DOCUMENT SUMMARY:
This final rule with comment period revises 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 final rule with comment period, we describe the 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, 2010.
In addition, this final rule with comment period updates 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 final rule with comment period, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these changes will apply, and other pertinent ratesetting information for the CY 2010 ASC payment system. These changes are applicable to services furnished on or after January 1, 2010.
SUMMARY:
Health and Human Services Department, Centers for Medicare & Medicaid Services
SUPPLEMENTAL INFORMATION
Comment Subject Areas: We will consider comments on the following
subject areas discussed in this final rule with comment period that are
received by the date and time indicated in the DATES section of this final rule with comment period:
(1) The payment classifications assigned to HCPCS codes identified
in Addenda B, AA, and BB to this final rule with comment period with the ``NI'' comment indicator;
(2) Recognition of plasma protein fraction as a blood product or a
biological for OPPS payment, as discussed in section II.A.1.d.(2) of this final rule with comment period;
(3) Potential alternative coding schemes for reporting hospital
clinic visits for new and established patients, as discussed in section IX.B.1. of this final rule with comment period;
(4) The possibility of extending the direct supervision
requirements for hospitalbased partial hospitalization program
services to those same services in community mental health centers, as
discussed in section XII.D.3. of this final rule with comment period; and
(5) The possibility of establishing direct physician supervision
requirements for ASC services, as discussed in section XV.A.3. of this final rule with comment period.
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
[[Page 60317]]
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
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 dialin. 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 login as guest (no
password required). Dialin users should use communications software
and modem to call (202) 5121661; type swais, then login as guest (no password required).
Alphabetical List of Acronyms Appearing in This Final 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
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
HOPQDRP 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 Contractor
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
PBD Providerbased department
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
RAC Recovery Audit Contractor
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 final rule with comment period and
in Addenda A, B, C (Addendum C is available on the Internet only; we
refer readers to section XVIII.A. of this final rule with comment
period), D1, D2, E, L, and M to this final rule with comment period.
The provisions related to the revised ASC payment system are included
in sections XV., XVI., and XVIII. through XXI. of this final rule with
comment period and in Addenda AA, BB, DD1, DD2, and EE to this final
rule with comment period. (Addendum EE is available on the Internet
only; we refer readers to section XVIII.B. of this final rule with comment period.)
Table of Contents
I. Background and Summary of the CY 2010 OPPS/ASC Final Rule With Comment Period
A. Legislative and Regulatory Authority for the Hospital Outpatient Prospective Payment System
B. Excluded OPPS Services and Hospitals
C. Prior Rulemaking
D. Advisory Panel on Ambulatory Payment Classification (APC) Groups
1. Authority of the APC Panel
2. Establishment of the APC Panel
3. APC Panel Meetings and Organizational Structure
E. Background and Summary of the CY 2010 OPPS/ASC Proposed Rule
1. Updates Affecting OPPS Payments
[[Page 60318]]
2. OPPS Ambulatory Payment Classification (APC) Group Policies
3. OPPS Payment for Devices
4. OPPS Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals
5. Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
6. OPPS Payment for Brachytherapy Sources
7. OPPS Payment for Drug Administration Services
8. OPPS Payment for Hospital Outpatient Visits
9. Payment for Partial Hospitalization Services
10. Procedures That Will Be Paid Only as Inpatient Services
11. OPPS Nonrecurring Technical and Policy Changes and Clarifications
12. OPPS Payment Status and Comment Indicators
13. OPPS Policy and Payment Recommendations
14. Updates to the Ambulatory Surgical Center (ASC) Payment System
15. Reporting Quality Data for Annual Payment Rate Updates
16. HealthcareAssociated Conditions
17. Regulatory Impact Analysis
F. Public Comments Received in Response to the CY 2010 OPPS/ASC Proposed Rule
G. Public Comments Received in Response to the November 18, 2008 OPPS/ASC Final Rule With Comment Period
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Weights
1. Database Construction
a. Database Source and Methodology
b. Use of Single and Multiple Procedure Claims
c. Calculation of CCRs
(1) Development of the CCRs
(2) Charge Compression
2. Data Development Process and Calculation of Median Costs
a. Claims Preparation
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. Calculation of Single Procedure APC CriteriaBased Median Costs
(1) DeviceDependent APCs
(2) Blood and Blood Products
(3) Single Allergy Tests
(4) Echocardiography Services
(5) Nuclear Medicine Services
(6) Hyperbaric Oxygen Therapy
(7) Payment for Ancillary Outpatient Services When Patient Expires (CA Modifier)
e. 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. Calculation of OPPS Scaled Payment Weights
4. Changes to Packaged Services
a. Background
b. Packaging Issues
(1) Packaged Services Addressed by the February 2009 APC Panel Recommendations
(2) Packaged Services Addressed by the August 2009 APC Panel Recommendations
(3) Other ServiceSpecific Packaging Issues
B. Conversion Factor Update
C. Wage Index Changes
D. Statewide Average Default CCRs
E. OPPS Payment to Certain Rural and Other Hospitals
1. Hold Harmless Transitional Payment Changes Made by Public Law 110275 (MIPPA)
2. Adjustment for Rural SCHs Implemented in CY 2006 Related to Pub. L. 108173 (MMA)
F. Hospital Outpatient Outlier Payments
1. Background
2. Outlier Calculation
3. Final Outlier Calculation
4. Outlier Reconciliation
G. Calculation of an Adjusted Medicare Payment From the National Unadjusted Medicare Payment
H. Beneficiary Copayments
1. Background
2. Copayment Policy
3. Calculation of an Adjusted Copayment Amount for an APC Group III. OPPS Ambulatory Payment Classification (APC) Group Policies
A. OPPS Treatment of New CPT and Level II HCPCS Codes
1. Treatment of New Level II HCPCS Codes and Category I CPT Vaccine Codes and Category III CPT Codes
2. Process for New Level II HCPCS Codes and Category I and
Category III CPT Codes for Which We Are Soliciting Public Comments on the CY 2010 OPPS/ASC Final Rule With Comment Period
B. OPPS ChangesVariations Within APCs
1. Background
2. Application of the 2 Times Rule
3. Exceptions to the 2 Times Rule
C. New Technology APCs
1. Background
2. Movement of Procedures From New Technology APCs to Clinical APCs
D. OPPS APCSpecific Policies
1. Cardiovascular Services
a. Cardiovascular Telemetry (APC 0209)
b. Implantable Loop Recorder Monitoring (APC 0689)
c. Transluminal Balloon Angioplasty (APC 0279)
2. Gastrointestinal Services
a. Change of Gastrostomy Tube (APC 0676)
b. Laparoscopic Liver Cryoablation (APC 0131)
c. Cholangioscopy (APC 0151)
d. Laparoscopic Hernia Repair (APC 0131)
3. Genitourinary Services
a. Percutaneous Renal Cryoablation (APC 0423)
b. Hemodialysis (APC 0170)
c. Radiofrequency Remodeling of Bladder Neck (APC 0165)
d. Change of Bladder Tube (APC 0121)
4. Nervous System Services
a. PainRelated Procedures (APCs 0203, 0204, 0206, 0207, 0221, 0224, and 0388)
b. Magnetoencephalography (APCs 0065 and 0067)
5. Ocular Services
a. Insertion of Anterior Segment Aqueous Drainage Device (APC 0234)
b. Backbench Preparation of Corneal Allograft
6. Orthopedic and Musculoskeletal Services
a. Arthroscopic Procedures (APCs 0041 and 0042)
b. Knee Arthroscopy (APCs 0041 and 0042)
c. Shoulder Arthroscopy (APC 0042)
d. Fasciotomy Procedures (APC 0049)
e. Fibula Repair (APC 0062)
f. Forearm Orthopedic Procedures (APCs 0050, 0051, and 0052)
g. Low Energy Extracorporeal Shock Wave Therapy (Low Energy ESWT)
h. Insertion of Posterior Spinous Process Distraction Device (APC 0052)
7. Radiation Therapy Services
a. Proton Beam Therapy (APCs 0664 and 0667)
b. Stereotactic Radiosurgery (SRS) Treatment Delivery Services (APCs 0065, 0066, 0067, and 0127)
c. Clinical Brachytherapy (APCs 0312 and 0651)
8. Other Services
a. Low Frequency, NonContact, NonThermal Ultrasound (APC 0013)
b. Skin Repair (APCs 0134 and 0135)
c. Group Psychotherapy (APC 0325)
d. Portable XRay Services
e. Home Sleep Study Tests (APC 0213)
IV. OPPS Payment for Devices
A. PassThrough Payments for Devices
1. Expiration of Transitional PassThrough Payments for Certain Devices
2. Provisions for Reducing Transitional PassThrough Payments To Offset Costs Packaged Into APC Groups
a. Background
b. Final Policy
B. Adjustment to OPPS Payment for No Cost/Full Credit and Partial Credit Devices
1. Background
2. APCs and Devices Subject to the Adjustment Policy V. OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. OPPS Transitional PassThrough Payment for Additional Costs of Drugs, Biologicals, and Radiopharmaceuticals
1. Background
2. Drugs and Biologicals With Expiring PassThrough Status in CY 2009
3. Drugs, Biologicals, and Radiopharmaceuticals With New or Continuing PassThrough Status in CY 2010
4. PassThrough Payments for Implantable Biologicals
a. Background
b. Policy for CY 2010
5. Definition of PassThrough Payment Eligibility Period for New Drugs and Biologicals
6. Provision for Reducing Transitional PassThrough Payments for Diagnostic
[[Page 60319]]
Radiopharmaceuticals and Contrast Agents To Offset Costs Packaged Into APC Groups
a. Background
b. Payment Offset Policy for Diagnostic Radiopharmaceuticals
c. Payment Offset Policy for Contrast Agents
B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals Without PassThrough Status
1. Background
2. Criteria for Packaging Payment for Drugs, Biologicals, and Radiopharmaceuticals
a. Background
b. Cost Threshold for Packaging of Payment for HCPCS Codes That Describe Certain Drugs, Nonimplantable Biologicals, and Therapeutic Radiopharmaceuticals (``ThresholdPackaged Drugs'')
c. Packaging Determination for HCPCS Codes That Describe the Same Drug or Biological But Different Dosages
d. Packaging of Payment for Diagnostic Radiopharmaceuticals, Contrast Agents, and Implantable Biologicals (``PolicyPackaged'' Drugs and Devices)
3. Payment for Drugs and Biologicals Without PassThrough Status That Are Not Packaged
a. Payment for Specified Covered Outpatient Drugs (SCODs) and Other Separately Payable and Packaged Drugs and Biologicals
b. Payment Policy
4. Payment for Blood Clotting Factors
5. Payment for Therapeutic Radiopharmaceuticals
a. Background
b. Payment Policy
6. Payment for NonpassThrough Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes, But Without OPPS Hospital Claims Data
VI. Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
A. Background
B. Estimate of PassThrough Spending
VII. OPPS Payment for Brachytherapy Sources
A. Background
B. OPPS Payment Policy
VIII. OPPS Payment for Drug Administration Services
A. Background
B. Coding and Payment for Drug Administration Services IX. OPPS Payment for Hospital Outpatient Visits
A. Background
B. Policies for Hospital Outpatient Visits
1. Clinic Visits: New and Established Patient Visits
2. Emergency Department Visits
3. Visit Reporting Guidelines
X. Payment for Partial Hospitalization Services
A. Background
B. PHP APC Update for CY 2010
C. Separate Threshold for Outlier Payments to CMHCs XI. Procedures That Will Be Paid Only as Inpatient Procedures
A. Background
B. Changes to the Inpatient List
XII. OPPS Nonrecurring Technical and Policy Changes and
Clarifications
A. Kidney Disease Education Services
1. Background
2. Payment for Services Furnished by Providers of Services Located in a Rural Area
B. Pulmonary Rehabilitation, Cardiac Rehabilitation, and Intensive Cardiac Rehabilitation Services
1. Legislative Changes
2. Payment for Services Furnished to Hospital Outpatients in a Pulmonary Rehabilitation Program
3. 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. Policies for Direct Supervision of Hospital and CAH Outpatient Therapeutic Services
4. Policies for Direct Supervision of Hospital and CAH Outpatient Diagnostic Services
5. Summary of CY 2010 Physician Supervision Final Policies
E. Direct Referral for Observation Services
XIII. OPPS Payment Status and Comment Indicators
A. OPPS Payment 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 on Outpatient Claims
B. Comment Indicator Definitions
XIV. OPPS Policy and Payment Recommendations
A. MedPAC Recommendations
B. APC Panel Recommendations
C. OIG Recommendations
XV. 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. Treatment of New Codes
1. Treatment of New Category I and III CPT Codes and Level II HCPCS Codes
2. Treatment of New Level II HCPCS Codes Implemented in April and July 2009
C. Update to the List of ASC Covered Surgical Procedures and Covered Ancillary Services
1. Covered Surgical Procedures
a. Additions to the List of ASC Covered Surgical Procedures
b. Covered Surgical Procedures Designated as OfficeBased (1) Background
(2) Changes to Covered Surgical Procedures Designated as Office Based for CY 2010
c. ASC Covered Surgical Procedures Designated as Device Intensive
(1) Background
(2) Changes to List of Covered Surgical Procedures Designated as DeviceIntensive for CY 2010
d. ASC Treatment of Surgical Procedures Removed From the OPPS Inpatient List for CY 2010
2. Covered Ancillary Services
D. ASC Payment for Covered Surgical Procedures and Covered Ancillary Services
1. Payment for Covered Surgical Procedures
a. Background
b. Update to ASC Covered Surgical Procedure Payment Rates for CY 2010
c. Adjustment to ASC Payments for No Cost/Full Credit and Partial Credit Devices
2. Payment for Covered Ancillary Services
a. Background
b. 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 Requests for Payment Adjustment
a. Background
b. Request To Establish New NTIOL Class for CY 2010 and Deadline for Public Comment
4. Payment Adjustment
5. ASC Payment for Insertion of IOLs
6. Announcement of CY 2010 Deadline for Submitting Requests for
CMS Review of Appropriateness of ASC Payment for Insertion of an NTIOL Following Cataract Surgery
F. ASC Payment and Comment Indicators
1. Background
2. ASC Payment and Comment Indicators
G. ASC Policy and Payment Recommendations
H. Revision to Terms of Agreements for HospitalOperated ASCs
1. Background
2. Changes to the Terms of Agreements for ASCs Operated by Hospitals
I. Calculation of the ASC Conversion Factor and ASC Payment Rates
1. Background
2. 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 ASC Payment Rates
XVI. Reporting Quality Data for Annual Payment Rate Updates
A. Background
1. Overview
[[Page 60320]]
2. Hospital Outpatient Quality Data Reporting Under Section 109(a) of Public Law 109432
3. Reporting ASC Quality Data for Annual Payment Update
4. HOPQDRP Quality Measures for the CY 2009 Payment Determination
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. Quality Measures for the CY 2011 Payment Determination
1. Considerations in Expanding and Updating Quality Measures Under the HOP QDRP Program
2. Retirement of HOP QDRP Quality Measures
3. HOP QDRP Quality Measures for the CY 2011 Payment Determination
C. Possible Quality Measures Under Consideration for CY 2012 and Subsequent Years
D. Payment Reduction for Hospitals That Fail To Meet the HOP QDRP Requirements for the CY 2010 Payment Update
1. Background
2. Reporting Ratio Application and Associated Adjustment Policy for CY 2010
E. 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. Data Validation Requirements for CY 2011
b. Data Validation Approach for CY 2012 and Subsequent Years
c. Additional Data Validation Conditions Under Consideration for CY 2012 and Subsequent Years
F. 2010 Publication of HOP QDRP Data
G. 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 CY 2010 Hospital OPPS
B. Information in Addenda Related to the CY 2010 ASC Payment System
XIX. Collection of Information Requirements
A. Legislative Requirements for Solicitation of Comments
B. Associated Information Collections Not Specified in Regulatory Text
1. Hospital Outpatient Quality Data Reporting Program (HOP QDRP)
2. HOP QDRP Quality Measures for the CY 2010 and CY 2011 Payment Determinations
3. HOP QDRP Validation Requirements
4. HOP QDRP Reconsideration and Appeals Procedures
5. Additional Topics
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 Final Rule With Comment Period
1. Alternatives Considered
2. Limitations of Our Analysis
3. Estimated Effects of This Final Rule With Comment Period on Hospitals
4. Estimated Effects of This Final Rule With Comment Period on CMHCs
5. Estimated Effects of This Final Rule With Comment Period on Beneficiaries
6. Conclusion
7. Accounting Statement
C. Effects of ASC Payment System Changes in This Final Rule With Comment Period
1. Alternatives Considered
2. Limitations of Our Analysis
3. Estimated Effects of This Final Rule With Comment Period on Payments to ASCs
4. Estimated Effects of This Final Rule With Comment Period on Beneficiaries
5. Conclusion
6. Accounting Statement
D. Effects of Requirements for Reporting of Quality Data for Annual Hospital Payment Update
E. Executive Order 12866
Regulation Text
Addenda
Addendum AFinal OPPS APCs for CY 2010
Addendum AAFinal ASC Covered Surgical Procedures for CY 2010
(Including Surgical Procedures for Which Payment Is Packaged) Addendum BFinal OPPS Payment by HCPCS Code for CY 2010
Addendum BBFinal ASC Covered Ancillary Services Integral to
Covered Surgical Procedures for CY 2010 (Including Ancillary Services for Which Payment Is Packaged)
Addendum D1Final OPPS Payment Status Indicators for CY 2010 Addendum DD1Final ASC Payment Indicators for CY 2010
Addendum D2Final OPPS Comment Indicators for CY 2010
Addendum DD2Final ASC Comment Indicators for CY 2010
Addendum E HCPCS Codes That Are Paid as Inpatient Procedures for CY 2010
Addendum LCY 2010 OPPS OutMigration Adjustment
Addendum MHCPCS Codes for Assignment to Composite APCs for CY 2010
I. Background and Summary of the CY 2010 OPPS/ASC Final Rule With Comment Period
A. Legislative and Regulatory Authority for the Hospital Outpatient Prospective Payment System
When Title XVIII of the Social Security Act (the Act) 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 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
[[Page 60321]]
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 final rule with comment period. 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 108
173 added provisions for Medicare 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 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 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 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, we 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 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.
On July 20, 2009, we issued in the Federal Register (74 FR 35232) a
proposed rule for the CY 2010 OPPS/ASC payment system to implement
statutory requirements and changes arising from our continuing experience with both systems.
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D. Advisory Panel on Ambulatory Payment Classification (APC) 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 final rule with comment period, 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 16 meetings, with the last meeting taking place on August 5 and 6, 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 August 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.
Discussions of the other recommendations made by the APC Panel at the August 2009 meeting are included in the sections of this final rule with comment period 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.
Comment: Several commenters requested that CMS include ASC representation on the APC Panel. Because the revised ASC payment system is based upon the same APC groups and relative payment weights as the OPPS, the commenters believed that ASC representation on the APC Panel would ensure input from representatives of all care settings that provide surgical services whose payment groups and payment weights are affected by the OPPS. Further, the commenters urged CMS to revise the APC Panel's charter to reflect the current alignment of the OPPS and the revised ASC payment system by including representation from the ASC industry on the APC Panel, as the commenters believed is permitted by the statute.
Response: We acknowledge that the revised ASC payment system
provides Medicare payments to ASCs for surgical procedures that are
based, in most cases, on the relative payment weights of the OPPS.
However, CMS is statutorily required to have an appropriate selection
of representatives of ``providers'' as members of the APC Panel. The
current APC Panel charter requires that ``Each Panel member must be
employed fulltime by a hospital, hospital system, or other Medicare
provider subject to payment under the OPPS,'' which does not include
ASCs because ASCs are not providers. We refer readers to section
1833(t)(9)(A) of the Act and Sec. 400.202 of our regulations for
specific requirements and definitions. ASCs are suppliers, not
providers. The charter must comply with the statute, which does not
include representatives of suppliers on the APC Panel. Therefore,
although we understand the concerns of the commenters regarding ASC
input on the APC Panel now that the ASC payment system is based on the
OPPS relative payment weights, we cannot revise the charter to include ASC representation.
E. Background and Summary of the CY 2010 OPPS/ASC Proposed Rule
A proposed rule appeared in the July 20, 2009 Federal Register (74
FR 35232) that 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 set
forth proposed changes to the revised Medicare ASC payment system for
CY 2010, including updated payment weights, covered surgical
procedures, and covered ancillary items and services based on the
proposed OPPS update. Finally, we set 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
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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. The following is a
summary of the major proposed changes included in the CY 2010 OPPS/ASC proposed rule:
1. Updates Affecting OPPS Payments
In section II. of the proposed rule, we set forth
In section III. of the proposed rule, we discussed
3. OPPS Payment for Devices
In section IV. of the proposed rule, we discussed the proposed
passthrough payment for specific categories of devices and the
proposed adjustment for devices furnished at no cost or with partial or full credit.
4. OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
In section V. of the proposed rule, we discussed the 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. Estimate of OPPS Transitional PassThrough Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices
In section VI. of the proposed rule, we discussed the estimate of CY 2010 OPPS transitional passthrough spending for drugs, biologicals, and devices.
6. OPPS Payment for Brachytherapy Sources
In section VII. of the proposed rule, we discussed payment for brachytherapy sources.
7. OPPS Payment for Drug Administration Services
In section VIII. of the proposed rule, we set forth our proposed policy concerning coding and payment for drug administration services. 8. OPPS Payment for Hospital Outpatient Visits
In section IX. of the 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. Payment for Partial Hospitalization Services
In section X. of the proposed rule, we set forth the proposed
payment for partial hospitalization services, including the proposed separate threshold for outlier payments for CMHCs.
10. Procedures That Will Be Paid Only as Inpatient Procedures
In section XI. of the proposed rule, we discussed the procedures
that we proposed to remove from the inpatient list and assign to APCs for payment under the OPPS.
11. OPPS Nonrecurring Technical and Policy Changes and Clarifications
In section XII. of the proposed rule, we discussed nonrecurring technical issues, proposed policy changes, and provided policy clarifications.
12. OPPS Payment Status and Comment Indicators
In section XIII. of the proposed rule, we discussed our proposed changes to the definitions of status indicators assigned to APCs and presented our proposed comment indicators for the final rule with comment period.
13. OPPS Policy and Payment Recommendations
In section XIV. of the proposed rule, we addressed 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. Updates to the Ambulatory Surgical Center (ASC) Payment System
In section XV. of the proposed rule, we discussed the proposed updates of the revised ASC payment system and payment rates for CY 2010.
15. Reporting Quality Data for Annual Payment Rate Updates
In section XVI. of the proposed rule, we discussed the proposed quality measures for reporting hospital outpatient (HOP) quality data for the annual payment update factor for CY 2011 and subsequent calendar years; set forth the requirements for data collection and submission for the annual payment update; and discussed the 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 the proposed rule, we discussed 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 the proposed rule, we set forth an analysis of
the impact the proposed changes would have on affected entities and beneficiaries.
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F. Public Comments Received in Response to the CY 2010 OPPS/ASC Proposed Rule
We received approximately 1,527 timely pieces of correspondence containing multiple comments on the CY 2010 OPPS/ASC proposed rule. We note that we received some public comments that were outside of the scope of the CY 2010 OPPS/ASC proposed rule. These outofscope public comments are not addressed in this final rule with comment period.
New (and substantially revised) CY 2010 HCPCS codes are designated
with comment indicator ``NI'' in Addenda B, AA, and BB of this final
rule with comment period to signify that their CY 2010 interim OPPS
and/or ASC treatment are open to public comment on this final rule with
comment period. Summaries of the public comments that are within the
scope of the CY 2010 proposals and our responses to those comments are
set forth in the various sections of this final rule with comment period under the appropriate headings.
G. Public Comments Received in Response to the November 18, 2008 OPPS/ ASC Final Rule With Comment Period
We received approximately 41 timely pieces of correspondence on the
CY 2009 OPPS/ASC final rule with comment period, some of which
contained multiple comments on the interim APC assignments and/or
status indicators of HCPCS codes identified with comment indicator
``NI'' in Addendum B of that final rule with comment period. Summaries
of those public comments on topics open to comment in the CY 2009 OPPS/
ASC final rule with comment period and our responses to them are set
forth in the various sections of this final rule with comment period under the appropriate headings.
II. Updates Affecting OPPS Payments
A. 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 proposed 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 proposed to recalibrate the relative payment weights for each APC based on claims and cost report data for hospital outpatient department (HOPD) services. We proposed to use the most recent available data to construct the database for calculating APC group weights. Therefore, for the purpose of recalibrating the APC relative payment weights for CY 2010, we used approximately 141 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 final rule with comment period on the CMS Web site at: http://www.cms.hhs.gov/HospitalOutpatientPPS/ HORD/.)
Of the 141 million final action claims for services provided in hospital outpatient settings used to calculate the CY 2010 OPPS payment rates for this final rule with comment period, approximately 107 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 107 million claims, approximately 50 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 58 million claims, we created approximately 99 million single records, of which approximately 68 million were ``pseudo'' single or ``single session'' claims (created from 26 million multiple procedure claims using the process we discuss later in this section). Approximately 657,000 claims were trimmed out on cost or units in excess of +/3 standard deviations from the geometric mean, yielding approximately 99 million single bills for median setting. As described in section II.A.2. of this final rule with comment period, our data development process is designed with the goal of using appropriate cost information in setting the APC relative weights. The bypass process is described in section II.A.1.b. of this final rule with comment period. This section 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.
As proposed, the APC relative weights and payments for CY 2010 in Addenda A and B to this final rule with comment period 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 underpinning the APC relative payment weights and the CY 2010 payment rates.
We did not receive any public comments on our proposal to base the CY 2010 APC relative weights on the most currently available cost reports and on claims for services furnished in CY 2008. Therefore, for the reasons noted above in this section, we are finalizing our data source for the recalibration of the CY 2010 APC relative payment weights as proposed, without modification, as described in this section of this final rule with comment period.
b. Use of Single and Multiple Procedure Claims
For CY 2010, in general, we proposed 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
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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 spanning multiple dates of service, or 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 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), which also increased the number
of bills we were able to use to calculate APC median costs. We refer
readers to section II.A.2.e. of this final rule with comment period for
discussion of the use of claims to establish median costs for composite APCs.
In the CY 2010 OPPS/ASC proposed rule (74 FR 35239 through 35241), we proposed 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 final rule with comment period, approximately 68 million ``pseudo'' single claims, including multiple imaging composite ``single session'' bills (we refer readers to section II.A.2.e.(5) of this final rule with comment period for further discussion), to add to the approximately 32 million ``natural'' single bills. For this final rule with comment period, ``pseudo'' single and ``single session'' procedure bills represent 68 percent of all single bills used to calculate median costs.
In the CY 2010 OPPS/ASC proposed rule (74 FR 35239 through 35241),
we proposed to bypass 438 HCPCS codes for CY 2010. 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 on each ``natural'' single bill for each code. Each
year, we generally retain the codes on the previous year's bypass list
and use 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 and CY 2007 claims data processed through June 30,
2008 used to model the final payment rates for CY 2009) to determine
whether it would be appropriate to propose to add additional codes to
the previous year's bypass list. For CY 2010, we proposed to continue
to bypass all of the HCPCS codes on the CY 2009 OPPS bypass list. We
also proposed 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, met the same previously established
empirical criteria for the bypass list that are summarized below.
Because we must make some assumptions about packaging in the multiple
procedure claims in order to assess a HCPCS code for addition to the
bypass list, we assume that the representation of packaging on
``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 were:
In addition, we proposed 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 packaging associated with specific services, especially on a multiple procedure claim. We also proposed to continue to include on the bypass list certain HCPCS codes in order to purposefully direct the assignment of packaged costs to a companion code where services always appear together and where 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 associated 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 ``over
FOR FURTHER INFORMATION CONTACT
Alberta Dwivedi, (410) 7860378, Hospital outpatient prospective payment issues.
Dana Burley, (410) 7860378, Ambulatory surgical center issues.
Michele Franklin, (410) 7864533, and Jana Lindquist, (410) 7864533,
Partial hospitalization and community mental health center issues.
James Poyer, (410) 7862261, Reporting of quality data issues.