[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Rules and Regulations]
[Pages 68210-68565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26902]
[[Page 68209]]
Vol. 77
Thursday,
No. 221
November 15, 2012
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 416, 419, 476, et al.
Medicare and Medicaid Programs: Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems and Quality
Reporting Programs; Electronic Reporting Pilot; Inpatient
Rehabilitation Facilities Quality Reporting Program; Revision to
Quality Improvement Organization Regulations; Final Rule
Federal Register / Vol. 77 , No. 221 / Thursday, November 15, 2012 /
Rules and Regulations
[[Page 68210]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 416, 419, 476, 478, 480, and 495
[CMS-1589-FC]
RIN 0938-AR10
Medicare and Medicaid Programs: Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems and Quality
Reporting Programs; Electronic Reporting Pilot; Inpatient
Rehabilitation Facilities Quality Reporting Program; Revision to
Quality Improvement Organization Regulations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period revises the Medicare
hospital outpatient prospective payment system (OPPS) and the Medicare
ambulatory surgical center (ASC) payment system for CY 2013 to
implement applicable statutory requirements and changes arising from
our continuing experience with these systems. In this final rule with
comment period, we describe the changes to the amounts and factors used
to determine the payment rates for Medicare services paid under the
OPPS and those paid under the ASC payment system. In addition, this
final rule with comment period updates and refines the requirements for
the Hospital Outpatient Quality Reporting (OQR) Program, the ASC
Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation
Facility (IRF) Quality Reporting Program. We are continuing the
electronic reporting pilot for the Electronic Health Record (EHR)
Incentive Program, and revising the various regulations governing
Quality Improvement Organizations (QIOs), including the secure
transmittal of electronic medical information, beneficiary complaint
resolution and notification processes, and technical changes. The
technical changes to the QIO regulations reflect CMS' commitment to the
general principles of the President's Executive Order on Regulatory
Reform, Executive Order 13563 (January 18, 2011).
DATES: Effective Date: This final rule with comment period is effective
on January 1, 2013.
Comment Period: To be assured consideration, comments on the
payment classifications assigned to HCPCS codes identified in Addenda
B, AA, and BB of this final rule with comment period with the ``NI''
comment indicator and on other areas specified throughout this final
rule with comment period must be received at one of the addresses
provided in the ADDRESSES section no later than 5 p.m. EST on December
31, 2012.
Application Deadline--New Class of New Technology Intraocular
Lenses: Requests for review of applications for a new class of new
technology intraocular lenses must be received by 5 p.m. EST on March
1, 2013, at the following address: ASC/NTOL, Division of Outpatient
Care, Mailstop C4-05-17, Centers for Medicare and Medicaid Services,
7500 Security Boulevard, Baltimore, MD 21244-1850.
ADDRESSES: In commenting, please refer to file code CMS-1589-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may (and we encourage you to) submit
electronic comments on this regulation to http://www.regulations.gov.
Follow the instructions under the ``submit a comment'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1589-FC, P.O. Box 8013,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments via
express or overnight mail to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1589-FC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal Government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call the telephone number (410) 786-7195 in advance to schedule
your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, we refer readers to the
beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Marjorie Baldo, (401) 786-4617, for issues related to new CPT and
Level II HCPCS codes, exceptions to the 2 times rule, and new
technology APCs.
Anita Bhatia, (410) 786-7236, Ambulatory Surgical Center Quality
Reporting (ASCQR) Program--Program Administration and Reconsideration
Issues.
Douglas Brown, (410) 786-0028, for issues related to Electronic
Health Record (EHR) Incentive Program Electronic Reporting Pilot.
Carrie Bullock, (401) 786-0378, for issues related to blood
products.
Erick Chuang, (410) 786-1816, for issues related to OPPS APC
weights, mean calculation, copayments, wage index, outlier payments,
and rural hospital payments.
Caroline Gallaher, (410) 786-8705, for issues related to Inpatient
Rehabilitation Facility (IRF) Quality Reporting Program.
Shaheen Halim (410) 786-0641, Hospital Outpatient Quality Reporting
Program (OQR)--Measures Issues and Publication of Hospital OQR Program
Data, and Ambulatory Surgical Center Quality Reporting (ASCQR)
Program--Measures Issues and Publication of ASCQR Program Data.
Twi Jackson, (410) 786-1159, for issues related to device-dependent
APCs, no cost/full credit and partial credit devices, hospital
outpatient visits, extended assessment and management composite APCs,
and inpatient-only procedures.
Thomas Kessler, (401) 786-1991, for issues related to QIO
regulations.
[[Page 68211]]
Marina Kushnirova, (410) 786-2682, for issues related to OPPS
status indicators and comment indicators.
Barry Levi, (410) 786-4529, for issues related to OPPS pass-through
devices, brachytherapy sources, intraoperative radiation therapy
(IORT), brachytherapy composite APC, multiple imaging composite APCs,
cardiac resynchronization therapy composite APC, and cardiac
electrophysiologic evaluation and ablation composite APC.
Jana Lindquist, (410) 786-4533, for issues related to partial
hospitalization and community mental health center (CMHC) issues.
Ann Marshall, (410) 786-3059, for issues related to hospital
outpatient supervision, outpatient status, proton beam therapy, and the
Hospital Outpatient Payment (HOP) Panel.
John McInnes, (410) 786-0378, for issues related to new technology
intraocular lenses (NTIOLs) and packaged items/services.
James Poyer, (410) 786-2261, Hospital Outpatient Quality
Reporting--Program Administration, Validation, and Reconsideration
Issues.
Char Thompson, (410) 786-2300, for issues related to OPPS drugs,
radiopharmaceuticals, biologicals, blood clotting factors, cost-to-
charge ratios (CCRs), and ambulatory surgical center (ASC) payments.
Marjorie Baldo, (410) 786-4617, for all other issues related to
hospital outpatient and ambulatory surgical center payments not
previously identified.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection, generally beginning approximately 3 weeks after publication
of the rule, at the headquarters of the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, MD 21244, on Monday
through Friday of each week from 8:30 a.m. to 4:00 p.m. EST. To
schedule an appointment to view public comments, phone 1-800-743-3951.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Printing Office. This database can be
accessed via the internet at http://www.gpo.gov/fdsys/.
Addenda Available Only Through the Internet on the CMS Web Site
In the past, a majority of the Addenda referred to in our OPPS/ASC
proposed and final rules were published in the Federal Register as part
of the annual rulemakings. However, beginning with the CY 2012 OPPS/ASC
proposed rule, all of the Addenda no longer appear in the Federal
Register as part of the annual OPPS/ASC proposed and final rules to
decrease administrative burden and reduce costs associated with
publishing lengthy tables. Instead, these Addenda will be published and
available only on the CMS Web site. The Addenda relating to the OPPS
are available at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. The Addenda relating to the
ASC payment system are available at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/index.html. Readers who
experience any problems accessing any of the Addenda that are posted on
the CMS Web site identified above should contact Charles Braver at
(410) 786-0378.
Alphabetical List of Acronyms Appearing in This Federal Register
Document
AHA American Hospital Association
AMA American Medical Association
APC Ambulatory Payment Classification
ASC Ambulatory surgical center
ASCQR Ambulatory Surgical Center Quality Reporting
ASP Average sales price
AWP Average wholesale price
BBA Balanced Budget Act of 1997, Public Law 105-33
BBRA Medicare, Medicaid, and SCHIP [State Children's Health
Insurance Program] Balanced Budget Refinement Act of 1999, Public
Law 106-113
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000, Public Law 106-554
BLS Bureau of Labor Statistics
CAH Critical access hospital
CAP Competitive Acquisition Program
CASPER Certification and Survey Provider Enhanced Reporting
CAUTI Catheter associated urinary tract infection
CBSA Core-Based Statistical Area
CCI Correct Coding Initiative
CCN CMS Certification Number
CCR Cost-to-charge ratio
CDC Centers for Disease Control and Prevention
CEO Chief executive officer
CERT Comprehensive Error Rate Testing
CFR Code of Federal Regulations
CLFS Clinical Laboratory Fee Schedule
CMHC Community mental health center
CMS Centers for Medicare & Medicaid Services
CoP [Medicare] Condition of participation
CPI-U Consumer Price Index for All Urban Consumers
CPT Current Procedural Terminology (copyrighted by the American
Medical Association)
CQM Clinical quality measure
CR Change request
CSAC Consensus Standards Approval Committee
CY Calendar year
DFO Designated Federal Official
DRA Deficit Reduction Act of 2005, Public Law 109-171
DRG Diagnosis-Related Group
DSH Disproportionate share hospital
EACH Essential access community hospital
eCQM Electronically specified clinical quality measure
ECT Electroconvulsive therapy
ED Emergency department
E/M Evaluation and management
EHR Electronic health record
ESRD End-stage renal disease
FACA Federal Advisory Committee Act, Public Law 92-463
FDA Food and Drug Administration
FFS [Medicare] Fee-for-service
FY Fiscal year
GAO Government Accountability Office
HAI Healthcare-associated infection
HCERA Health Care and Education Reconciliation Act of 2010, Public
Law 111-152
HCPCS Healthcare Common Procedure Coding System
HCRIS Hospital Cost Report Information System
HEU Highly enriched uranium
HIPAA Health Insurance Portability and Accountability Act of 1996,
Public Law 104-191
HITECH Health Information Technology for Economic and Clinical
Health [Act] (found in the American Recovery and Reinvestment Act of
2009, Public Law 111-5)
HOP Hospital Outpatient Payment [Panel]
HOPD Hospital outpatient department
ICD-9-CM International Classification of Diseases, Ninth Revision,
Clinical Modification
ICD Implantable cardioverter defibrillator
ICU Intensive care unit
IHS Indian Health Service
IMRT Intensity Modulated Radiation Therapy
I/OCE Integrated Outpatient Code Editor
IOL Intraocular lens
IOM Institute of Medicine
IORT Intraoperative radiation treatment
IPF Inpatient Psychiatric Facility
IPPS [Hospital] Inpatient Prospective Payment System
IQR [Hospital] Inpatient Quality Reporting
IRF Inpatient rehabilitation facility
IRF-PAI Inpatient Rehabilitation Facility-Patient Assessment
Instrument
[[Page 68212]]
IRF QRP Inpatient Rehabilitation Facility Quality Reporting Program
LDR Low dose rate
LOS Length of Stay
LTCH Long-term care hospital
MAC Medicare Administrative Contractor
MAP Measure Application Partnership
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multifactor productivity
MGCRB Medicare Geographic Classification Review Board
MIEA-TRHCA 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 110-275
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, Public Law 108-173
MMEA Medicare and Medicaid Extenders Act of 2010, Public Law. 111-
309
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007, Public
Law 110-173
MPFS Medicare Physician Fee Schedule
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Area
NCCI National Correct Coding Initiative
NHSN National Healthcare Safety Network
NQF National Quality Forum
NTIOL New technology intraocular lens
NUBC National Uniform Billing Committee
OACT [CMS] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act of 1996, Public Law 99-509
OIG [HHS] Office of the Inspector General
OMB Office of Management and Budget
OPD [Hospital] Outpatient Department
OPPS [Hospital] Outpatient Prospective Payment System
OPSF Outpatient Provider-Specific File
OQR [Hospital] Outpatient Quality Reporting
OT Occupational therapy
PCR Payment-to-cost ratio
PE Practice expense
PEPPER Program for Evaluating Payment Patterns Electronic Report
PHP Partial hospitalization program
PHS Public Health Service [Act], Public Law 96-88
PPI Producer Price Index
PPS Prospective payment system
PQRS Physician Quality Reporting System
PT Physical therapy
QDC Quality data code
QIO Quality Improvement Organization
RAC Recovery Audit Contractor
RFA Regulatory Flexibility Act
RTI Research Triangle Institute, International
RVU Relative value unit
SCH Sole community hospital
SCOD Specified covered outpatient drugs
SI Status indicator
SIR Standardized infection ratio
SLP Speech-language pathology
SNF Skilled Nursing Facility
SRS Stereotactic Radiosurgery
TEP Technical Expert Panel
TMS Transcranial Magnetic Stimulation Therapy
TOPs Transitional Outpatient Payments
UR Utilization review
USPSTF United States Preventive Services Task Force
UTI Urinary tract infection
VBP Value-based purchasing
WAC Wholesale acquisition cost
Table of Contents
I. Summary and Background
A. Executive Summary of This Final Rule With Comment Period
1. Purpose
2. Summary of the Major Provisions
3. Summary of Costs and Benefits
B. Legislative and Regulatory Authority for the Hospital OPPS
C. Excluded OPPS Services and Hospitals
D. Prior Rulemaking
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel
or the Panel), Formerly Named the Advisory Panel on Ambulatory
Payment Classification Groups (APC Panel)
1. Authority of the Panel
2. Establishment of the Panel
3. Panel Meetings and Organizational Structure
F. Public Comments Received in Response to the CY 2013 OPPS/ASC
Proposed Rule
G. Public Comments Received on the CY 2012 OPPS/ASC Final Rule
With Comment Period
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
1. Database Construction
a. Database Source and Methodology
b. Use of Single and Multiple Procedure Claims
c. Calculation and Use of Cost-to-Charge Ratios (CCRs)
2. Data Development Process and Calculation of Costs Used for
Ratesetting
a. Claims Preparation
b. Splitting Claims and Creation of ``Pseudo'' Single Procedure
Claims
(1) Splitting Claims
(2) Creation of ``Pseudo'' Single Procedure Claims
c. Completion of Claim Records and Geometric Mean Cost
Calculations
(1) General Process
(2) Recommendations of the Advisory Panel on Hospital Outpatient
Payment Regarding Data Development
d. Calculation of Single Procedure APC Criteria-Based Costs
(1) Device-Dependent APCs
(2) Blood and Blood Products
(3) Brachytherapy Sources
e. Calculation of Composite APC Criteria-Based 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)
(6) Cardiac Resynchronization Therapy Composite APC (APC 0108)
f. Geometric Mean-Based Relative Payment Weights
3. Changes to Packaged Services
a. Background
b. Clarification of Regulations at 42 CFR 419.2(b)
c. Packaging Recommendations of the HOP Panel (``The Panel'') at
its February 2012 Meeting
d. Packaging Recommendations of the HOP Panel (``The Panel'') at
its August 2012 Meeting
e. Other Packaging Proposals and Policies for CY 2013
f. Packaging of Drugs, Biologicals, and Radiopharmaceuticals
(1) Existing Packaging Policies
(2) Clarification of Packaging Policy for Anesthesia Drugs
g. Packaging of Payment for Diagnostic Radiopharmaceuticals,
Contrast Agents, and Implantable Biologicals (``Policy-Packaged''
Drugs and Devices)
h. Summary of Proposals
4. Calculation of OPPS Scaled Payment Weights
B. Conversion Factor Update
C. Wage Index Changes
D. Statewide Average Default CCRs
E. OPPS Payments to Certain Rural and Other Hospitals
1. Hold Harmless Transitional Payment Changes
2. Adjustment for Rural SCHs and EACHs Under Section
1833(t)(13)(B) of the Act
F. OPPS Payment to Certain Cancer Hospitals Described by Section
1886(d)(1)(B)(v) of the Act
1. Background
2. Payment Adjustment for Certain Cancer Hospitals for CY 2013
G. Hospital Outpatient Outlier Payments
1. Background
2. Proposed Outlier Calculation
3. Final Outlier Calculation
4. Outlier Reconciliation
H. Calculation of an Adjusted Medicare Payment From the National
Unadjusted Medicare Payment
I. Beneficiary Copayments
1. Background
2. OPPS 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 CY 2012 Level II HCPCS and CPT Codes
Effective April 1, 2012 and July 1, 2012 for Which We Solicited
Public Comments in the CY 2013 OPPS/ASC Proposed Rule
2. Process for New Level II HCPCS Codes That Will Be Effective
October 1, 2012 and New CPT and Level II HCPCS Codes That Will Be
Effective January 1, 2013 for Which We Are Soliciting Public
Comments in this CY 2013 OPPS/ASC Final Rule with Comment Period
B. OPPS Changes--Variations within APCs
1. Background
2. Application of the 2 Times Rule
3. Exceptions to the 2 Times Rule
C. New Technology APCs
1. Background
[[Page 68213]]
2. Movement of Procedures From New Technology APCs to Clinical
APCs
3. Payment Adjustment Policy for Radioisotopes Derived From Non-
Highly Enriched Uranium (HEU) Sources
a. Background
b. Payment Policy
D. OPPS APC-Specific Policies
1. Cardiovascular and Vascular Services
a. Cardiac Telemetry (APC 0213)
b. Mechanical Thrombectomy (APC 0653)
c. Non-Congenital Cardiac Catheterization (APC 0080)
d. Endovascular Revascularization of the Lower Extremity (APCs
0083, 0229, and 0319)
e. External Electrocardiographic Monitoring (APC 0097)
f. Echocardiography (APCs 0177, 0178, 0269, 0270, and 0697)
2. Gastrointestinal Services
a. Laparoscopic Adjustable Gastric Band (APC 0132)
b. Transoral Incisionless Fundoplication (APC 0422)
c. Gastrointestinal Transit and Pressure Measurement (APC 0361)
3. Integumentary System Services
a. Extracorporeal Shock Wave Wound Treatment (APC 0340)
b. Application of Skin Substitute (APCs 0133 and 0134)
c. Low Frequency, Non-Contact, Non-Thermal Ultrasound (APC 0015)
4. Nervous System Services
a. Scrambler Therapy (APC 0275)
b. Transcranial Magnetic Stimulation Therapy (TMS) (APC 0216)
c. Paravertebral Neurolytic Agent (APC 0207)
d. Programmable Implantable Pump (APC 0691)
e. Revision/Removal of Neurostimulator Electrodes (APC 0687)
5. Ocular Services: Placement of Amniotic Membrane (APC 0233)
6. Radiology Oncology
a. Proton Beam Therapy (APCs 0664 and 0667)
b. Device Construction for Intensity Modulated Radiation Therapy
(IMRT) (APC 0305)
c. Other Radiation Oncology Services (APCs 0310 and 0412)
d. Stereotactic Radiosurgery (SRS) Treatment Delivery Services
(APCs 0065, 0066, 0067 and 0127)
e. Intraoperative Radiation Therapy (IORT) (APC 0412)
(1) Background
(2) CY 2013 Proposals and Final Policies for CPT Codes 77424,
77425, and 77469
7. Imaging
a. Non-Ophthalmic Fluorescent Vascular Angiography (APC 0397)
b. Level II Nervous System Imaging (APC 0402)
c. Computed Tomography of Abdomen/Pelvis (APCs 0331 and 0334)
8. Respiratory Services
a. Bronchoscopy (APC 0415)
b. Upper Airway Endoscopy (APC 0075)
9. Other Services
a. Payment for Molecular Pathology Services
b. Bone Marrow (APC 0112)
IV. OPPS Payment for Devices
A. Pass-Through Payments for Devices
1. Expiration of Transitional Pass-Through Payments for Certain
Devices
a. Background
b. CY 2013 Policy
2. Provisions for Reducing Transitional Pass-Through Payments to
Offset Costs Packaged into APC Groups
a. Background
b. CY 2013 Policy
3. Clarification of Existing Device Category Criterion
a. Background
b. Clarification of CY 2013 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 Pass-Through Payment for Additional Costs
of Drugs, Biologicals, and Radiopharmaceuticals
1. Background
2. Drugs and Biologicals With Expiring Pass-Through Status in CY
2012
3. Drugs, Biologicals, and Radiopharmaceuticals With New or
Continuing Pass-Through Status in CY 2013
4. Provisions for Reducing Transitional Pass-Through Payments
for Diagnostic 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 Pass-Through 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 (``Threshold-Packaged Drugs'')
c. Packaging Determination for HCPCS Codes That Describe the
Same Drug or Biological but Different Dosages
3. Payment for Drugs and Biologicals Without Pass-Through Status
That Are Not Packaged
a. Payment for Specified Covered Outpatient Drugs (SCODs) and
Other Separately Payable and Packaged Drugs and Biologicals
b. CY 2013 Payment Policy
4. Payment Policy for Therapeutic Radiopharmaceuticals
5. Payment for Blood Clotting Factors
6. Payment for Nonpass-Through Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes, but Without OPPS Hospital
Claims Data
VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
B. Estimate of Pass-Through Spending
VII. OPPS Payment for Hospital Outpatient Visits
A. Background
B. Policies for Hospital Outpatient Visits
C. Transitional Care Management
VIII. Payment for Partial Hospitalization Services
A. Background
B. PHP APC Update for CY 2013
C. Coding Changes
D. Separate Threshold for Outlier Payments to CMHCs
IX. Procedures That Would Be Paid Only as Inpatient Procedures
A. Background
B. Changes to the Inpatient List
X. Policies for the Supervision of Outpatient Services in Hospitals
and CAHs
A. Conditions of Payment for Physical Therapy, Speech-Language
Pathology, and Occupational Therapy Services in Hospitals and CAHs
B. Enforcement Instruction for the Supervision of Outpatient
Therapeutic Services in CAHs and Certain Small Rural Hospitals
XI. Outpatient Status: Solicitation of Public Comments in the CY
2013 OPPS/ASC Proposed Rule
A. Background
B. Summary of Public Comments Received
1. Part A to Part B Rebilling
2. Clarifying Current Admission Instructions or Establishing
Specified Clinical Criteria
3. Hospital Utilization Review
4. Prior Authorization
5. Time-Based Criteria for Inpatient Admission
6. Payment Alignment
7. Public Comments on Other Topics
a. Rules for the External Review of Inpatient Claims
b. Improving Beneficiary Protections
c. Revising the Qualifying Criteria for Skilled Nursing Facility
(SNF) Coverage
C. Summary
XII. CY 2013 OPPS Payment Status and Comment Indicators
A. CY 2013 OPPS Payment Status Indicator Definitions
B. CY 2013 Comment Indicator Definitions
XIII. OPPS Policy and Payment Recommendations
A. MedPAC Recommendations
B. GAO Recommendations
C. OIG Recommendations
XIV. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
1. Legislative History, Statutory Authority, and Prior
Rulemaking for the ASC Payment System
2. 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. Process for Recognizing New Category I and Category III CPT
Codes and Level II HCPCS Codes
2. Treatment of New Level II HCPCS Codes and Category III CPT
Codes Implemented in April and July 2012 for Which We
[[Page 68214]]
Solicited Public Comments in the CY 2013 OPPS/ASC Proposed Rule
3. Process for New Level II HCPCS Codes and Category I and
Category III CPT Codes for Which We Are Soliciting Public Comments
in This CY 2013 OPPS/ASC Final Rule With Comment Period
C. Update to the Lists 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 Office-Based
(1) Background
(2) Changes for CY 2013 to Covered Surgical Procedures
Designated as Office-Based
c. ASC Covered Surgical Procedures Designated as Device-
Intensive
(1) Background
(2) Changes to List of Covered Surgical Procedures Designated as
Device-Intensive for CY 2013
d. Adjustment to ASC Payments for No Cost/Full Credit and
Partial Credit Devices
e. ASC Treatment of Surgical Procedures Removed From the OPPS
Inpatient List for CY 2013
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
2013
c. Waiver of Coinsurance and Deductible for Certain Preventive
Services
d. Payment for the Cardiac Resynchronization Therapy Composite
e. Payment for Low Dose Rate (LDR) Prostate Brachytherapy
Composite
2. Payment for Covered Ancillary Services
a. Background
b. Payment for Covered Ancillary Services for CY 2013
E. New Technology Intraocular Lenses (NTIOLs)
1. NTIOL Cycle and Evaluation Criteria
2. NTIOL Application Process for Payment Adjustment
3. Requests to Establish New NTIOL Classes for CY 2013 and
Deadline for Public Comments
4. Payment Adjustment
5. Revisions to the Major NTIOL Criteria Described in 42 CFR
416.195
6. Request for Public Comment on the ``Other Comparable Clinical
Advantages'' Improved Outcome
7. Announcement of CY 2013 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. Calculation of the ASC Conversion Factor and the ASC Payment
Rates
1. Background
2. Calculation of the ASC Payment Rates
a. Updating the ASC Relative Payment Weights for CY 2013 and
Future Years
b. Updating the ASC Conversion Factor
3. Display of CY 2013 ASC Payment Rates
XV. Hospital Outpatient Quality Reporting Program Updates
A. Background
1. Overview
2. Statutory History of the Hospital Outpatient Quality
Reporting (Hospital OQR) Program
3. Measure Updates and Data Publication
a. Process for Updating Quality Measures
b. Publication of Hospital OQR Program Data
B. Process for Retention of Hospital OQR Program Measures
Adopted in Previous Payment Determinations
C. Removal or Suspension of Quality Measures From the Hospital
OQR Program Measure Set
1. Considerations in Removing Quality Measures From the Hospital
OQR Program
2. Removal of One Chart-Abstracted Measure for the CY 2013 and
Subsequent Years Payment Determinations
3. Suspension of One Chart-Abstracted Measure for the CY 2014
and Subsequent Years Payment Determinations
4. Deferred Data Collection of OP-24: Cardiac Rehabilitation
Measure: Patient Referral From an Outpatient Setting for the CY 2014
Payment Determination
D. Quality Measures for CY 2015 Payment Determination
E. Possible Quality Measures Under Consideration for Future
Inclusion in the Hospital OQR Program
F. Payment Reduction for Hospitals That Fail To Meet the
Hospital OQR Program Requirements for the CY 2013 Payment Update
1. Background
2. Reporting Ratio Application and Associated Adjustment Policy
for CY 2013
G. Requirements for Reporting of Hospital OQR Data for the CY
2014 Payment Determination and Subsequent Years
1. Administrative Requirements for the CY 2014 Payment
Determination and Subsequent Years
2. Form, Manner, and Timing of Data Submitted for the Hospital
OQR Program for the CY 2014 Payment Determination and Subsequent
Years
a. Background
b. General Requirements
c. Chart-Abstracted Measure Requirements for CY 2014 and
Subsequent Payment Determination Years
d. Claims-Based Measure Data Requirements for the CY 2014 and CY
2015 Payment Determinations
e. Structural Measure Data Requirements for the CY 2014 Payment
Determination and Subsequent Years
f. Data Submission Requirements for OP-22: ED-Patient Left
Without Being Seen for the CY 2015 Payment Determination
g. Population and Sampling Data Requirements for the CY 2014
Payment Determination and Subsequent Years
3. Hospital OQR Program Validation Requirements for Chart-
Abstracted Measure Data Submitted Directly to CMS for the CY 2014
Payment Determination and Subsequent Years
a. Random Selection of Hospitals for Data Validation of Chart-
Abstracted Measures for the CY 2014 Payment Determination and
Subsequent Years
b. Targeting and Targeting Criteria for Data Validation
Selection for CY 2014 Payment Determination and for Subsequent Years
c. Methodology for Encounter Selection for the CY 2014 Payment
Determination and Subsequent Years
d. Validation Score Calculation for the CY 2014 Payment
Determination and Subsequent Years
H. Hospital OQR Reconsideration and Appeals Procedures for the
CY 2014 Payment Determination and Subsequent Years
I. Extraordinary Circumstances Extension or Waiver for the CY
2013 Payment Determination and Subsequent Years
J. Electronic Health Records (EHRs)
K. 2013 Medicare EHR Incentive Program Electronic Reporting
Pilot for Eligible Hospitals and CAHs
XVI. Requirements for the Ambulatory Surgical Centers Quality
Reporting (ASCQR) Program
A. Background
1. Overview
2. Statutory History of the ASC Quality Reporting (ASCQR)
Program
3. History of the ASCQR Program
B. ASCQR Program Quality Measures
1. Considerations in the Selection of ASCQR Program Quality
Measures
2. ASCQR Program Quality Measures
3. ASC Measure Topics for Future Consideration
4. Clarification Regarding the Process for Updating ASCQR
Program Quality Measures
C. Requirements for Reporting of ASC Quality Data
1. Form, Manner, and Timing for Claims-Based Measures for the CY
2014 Payment Determination and Subsequent Payment Determination
Years
a. Background
b. Form, Manner, and Timing for Claims-Based Measures for the CY
2015 Payment Determination and Subsequent Payment Determination
Years
2. Data Completeness and Minimum Threshold for Claims-Based
Measures Using QDCs
a. Background
b. Data Completeness Requirements for the CY 2015 Payment
Determination and Subsequent Payment Determination Years
3. Other Comments on the ASCQR Program
D. Payment Reduction for ASCs That Fail To Meet the ASCQR
Program Requirements
1. Statutory Background
2. Reduction to the ASC Payment Rates for ASCs That Fail To Meet
the ASCQR Program Requirements for the CY 2014 Payment Determination
and Subsequent Payment Determination Years
[[Page 68215]]
XVII. Inpatient Rehabilitation Facility (IRF) Quality Reporting
Program Updates
A. Overview
B. Updates to IRF QRP Measures Which Are Made as a Result of
Review by the National Quality Forum (NQF) Process
C. Process for Retention of IRF Quality Measures Adopted in
Previous Fiscal Year Rulemaking Cycles
D. Measures for the FY 2014 Payment Determination
1. Clarification Regarding Existing IRF Quality Measures That
Have Undergone Changes During the NQF Measure Maintenance Processes
2. Updates to the ``Percent of Residents Who Have Pressure
Ulcers That Are New or Worsened'' Measure
XVIII. Revisions to the Quality Improvement Organization (QIO)
Regulations (42 CFR Parts 476, 478, and 480)
A. Summary of Changes
B. Quality of Care Reviews
1. Beneficiary Complaint Reviews
2. Completion of General Quality of Care Reviews
C. Use of Confidential Information That Explicitly or Implicitly
Identifies Patients
D. Secure Transmissions of Electronic Versions of Medical
Information
E. Active Staff Privileges
F. Technical Corrections
XIX. Files Available to the Public Via the Internet
XX. Collection of Information Requirements
A. Legislative Requirements for Solicitation of Comments
B. Requirements in Regulation Text
1. 2013 Medicare EHR Incentive Program Electronic Reporting
Pilot for Hospitals and CAHs (Sec. 495.8)
C. Associated Information Collections Not Specified in
Regulatory Text
1. Hospital OQR Program
2. Hospital OQR Program Measures for the CY 2012, CY 2013, CY
2014 and CY 2015 Payment Determinations
a. Previously Adopted Hospital OQR Program Measures for the CY
2012, CY 2013, and CY 2014 Payment Determinations
b. Hospital OQR Program Measures for the CY 2014 Payment
Determination
c. Hospital OQR Program Measures for CY 2015
3. Hospital OQR Program Validation Requirements for CY 2014
4. Hospital OQR Program Reconsideration and Appeals Procedures
5. ASCQR Program Requirements
a. Claims-Based Outcome Measures for the CY 2014 Payment
Determination
b. Claims-Based Process, Structural, and Volume Measures for the
CY 2015 and CY 2016 Payment Determinations
c. Program Administrative Requirements and QualityNet Accounts;
Extraordinary Circumstance and Extension Requests; Reconsideration
Requests
6. IRF QRP
a. Pressure Ulcer Measure
b. CAUTI Measure
XXI. Waiver of Proposed Rulemaking and Response to Comments
A. Waiver of Proposed Rulemaking
B. Response to Comments
XXII. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impacts for OPPS and ASC Payment Provisions
4. Detailed Economic Analyses
a. Estimated Effects of OPPS Changes in This Final Rule With
Comment Period
(1) Limitations of Our Analysis
(2) Estimated Effects of OPPS Changes on Hospitals
(3) Estimated Effects of OPPS Changes on CMHCs
(4) Estimated Effect of OPPS Changes on Beneficiaries
(5) Estimated Effects of OPPS Changes on Other Providers
(6) Estimated Effects of OPPS Changes on the Medicare and
Medicaid Programs
(7) Alternative OPPS Policies Considered
b. Estimated Effects of ASC Payment System Final Policies
(1) Limitations of Our Analysis
(2) Estimated Effects of ASC Payment System Final Policies on
ASCs
(3) Estimated Effects of ASC Payment System Final Policies on
Beneficiaries
(4) Alternative ASC Payment Policies Considered
c. Effects of the Revisions to the QIO Regulations
d. Accounting Statements and Tables
e. Effects of Requirements for the Hospital OQR Program
f. Effects of the EHR Electronic Reporting Pilot
g. Effects of Proposals for the ASCQR Program
h. Effects of Updates to the IRF QRP
B. Regulatory Flexibility Act (RFA) Analysis
C. Unfunded Mandates Reform Act Analysis
D. Conclusion
XXIII. Federalism Analysis
Regulation Text
I. Summary and Background
A. Executive Summary of This Final Rule With Comment Period
1. Purpose
In this final rule with comment period, we are updating the payment
policies and payment rates for services furnished to Medicare
beneficiaries in hospital outpatient departments and Ambulatory
Surgical Centers (ASCs) beginning January 1, 2013. Section 1833(t) of
the Social Security Act (the Act) requires us to annually review and
update the relative payment weights and the conversion factor for
services payable under the Outpatient Prospective Payment System
(OPPS). Under section 1833(i) of the Act, we annually review and update
the ASC payment rates. We describe these and various other statutory
authorities in the relevant sections of this final rule.
In addition to establishing payment rates for CY 2013, we are
updating and implementing new requirements under the Hospital
Outpatient Quality Reporting (OQR) Program, the Ambulatory Surgical
Center Quality Reporting (ASCQR) Program, and the Inpatient
Rehabilitation Facility (IRF) Quality Reporting Program. We are
continuing the electronic reporting pilot for the Electronic Health
Record (EHR) Incentive Program and making revisions to the regulations
governing the Quality Improvement Organizations (QIOs), including the
secure transmittal of electronic medical information, beneficiary
complaint resolution and notification processes, and technical
corrections. The technical changes to the QIO regulations that we are
making to improve the regulations reflect CMS' commitment to the
principles of the President's Executive Order on Regulatory Reform,
Executive Order 13563 (January 18, 2011).
2. Summary of the Major Provisions
OPPS Update: For CY 2013, we are increasing the
payment rates under the OPPS by an Outpatient Department (OPD) fee
schedule increase factor of 1.8 percent. This increase is based on the
final hospital inpatient market basket percentage increase of 2.6
percent for inpatient services paid under the hospital inpatient
prospective payment system (IPPS), minus the multifactor productivity
(MFP) adjustment of 0.7 percentage points, and minus a 0.1 percentage
point adjustment required by the Affordable Care Act. Under this final
rule with comment period, we estimate that total payments for CY 2013,
including beneficiary cost-sharing, to the more than 4,000 facilities
paid under the OPPS (including general acute care hospitals, children's
hospitals, cancer hospitals, and community mental health centers
(CMHCs)), will be approximately $48.1 billion, an increase of
approximately $4.6 billion compared to CY 2012 payments, or $600
million excluding our estimated changes in enrollment, utilization, and
case-mix.
We are continuing to implement the statutory 2.0 percentage point
reduction in payments for hospitals failing to meet the hospital
outpatient quality reporting requirements, by applying a reporting
factor of 0.980 to the OPPS payments and copayments for all applicable
services.
Geometric Mean-Based Relative Payment Weights: CMS has
discretion under the statute to set OPPS payments based upon either the
estimated mean or median costs of services within an Ambulatory Payment
Classification (APC) group, the unit of payment. To improve our cost
estimation process, for
[[Page 68216]]
CY 2013 we are using the geometric mean costs of services within an APC
to determine the relative payment weights of services, rather than the
median costs that we have used since the inception of the OPPS. Our
analysis shows that the change to means will have a limited payment
impact on most providers, with a small number experiencing payment gain
or loss based on their service-mix.
Rural Adjustment: We are continuing the adjustment of 7.1
percent to the OPPS payments to certain rural sole community hospitals
(SCHs), including essential access community hospitals (EACHs). This
adjustment will apply to all services paid under the OPPS, excluding
separately payable drugs and biologicals, devices paid under the pass-
through payment policy, and items paid at charges reduced to cost.
Cancer Hospital Payment Adjustment: For CY 2013, we are
continuing our policy to provide additional payments to cancer
hospitals so that the hospital's payment-to-cost ratio (PCR) with the
payment adjustment is equal to the weighted average PCR for the other
OPPS hospitals using the most recent submitted or settled cost report
data. Based on those data, a target PCR of 0.91 will be used to
determine the CY 2013 cancer hospital payment adjustment to be paid at
cost report settlement. That is, the payment amount associated with the
cancer hospital payment adjustment will be the additional payment
needed to result in a PCR equal to 0.91 for each cancer hospital.
Payment Adjustment Policy for Radio-Isotopes Derived from
Non-Highly Enriched Uranium Sources: We are exercising our statutory
authority to make payment adjustments necessary to ensure equitable
payments in order to provide an adjustment for CY 2013 to cover the
marginal cost of hospital conversion to the use of non-HEU sources of
radio-isotopes used in medical imaging. The adjustment will cover the
marginal cost of radio-isotopes produced from non-HEU sources over the
costs of radio-isotopes produced by HEU sources.
Payment of Drugs, Biologicals, and Radiopharmaceuticals:
For CY 2013, payment for the acquisition and pharmacy overhead costs of
separately payable drugs and biologicals that do not have pass-through
status will be set at the statutory default of average sales price
(ASP) plus 6 percent.
Supervision of Hospital Outpatient Therapeutic Services:
We are clarifying the application of the supervision regulations to
physical therapy, speech-language pathology, and occupational therapy
services that are furnished in OPPS hospitals and critical access
hospitals (CAHs). In addition, in this final rule we note that we will
extend the enforcement instruction one final year through CY 2013. This
additional year, which we expect will be the final year of the
extension, will provide additional opportunities for stakeholders to
bring their issues to the Hospital Outpatient Payment Panel.
Outpatient Status: We are concerned about recent increases
in the length of time that Medicare beneficiaries spend as outpatients
receiving observation services. In addition, hospitals continue to
express concern about Medicare Part A to Part B rebilling policies when
a hospital inpatient claim is denied because the inpatient admission
was not medically necessary. In the CY 2013 OPPS/ASC proposed rule (77
FR 45155 through 45157), we provided an update on the Part A to Part B
Rebilling Demonstration that is in effect for CY 2012 through CY 2014,
which was designed to assist us in evaluating these issues. We also
solicited public comments on potential clarifications or changes to our
policies regarding patient status that may be appropriate, which we
discuss in this final rule with comment period.
Ambulatory Surgical Center Payment Update: For CY 2013, we
are increasing payment rates under the ASC payment system by 0.6
percent. This increase is based on a projected CPI-U update of 1.4
percent minus a multifactor productivity adjustment required by the
Affordable Care Act that is projected to be 0.8 percent. Based on this
update, we estimate that total payments to ASCs (including beneficiary
cost-sharing and estimated changes in enrollment, utilization, and
case-mix), for CY 2013 will be approximately $4.074 billion, an
increase of approximately $310 million compared to estimated CY 2012
payments.
New Technology Intraocular Lenses: We are revising the
regulations governing payments for new technology intraocular lenses
(NTIOLs) to require that the IOL's labeling, which must be approved by
the FDA, contain a claim of a specific clinical benefit based on a new
lens characteristic in comparison to currently available IOLs. We also
are revising the regulations to require that any specific clinical
benefit referred to in Sec. 416.195(a)(2) must be supported by
evidence that demonstrates that the IOL results in a measurable,
clinically meaningful, improved outcome.
Ambulatory Surgical Center Quality Reporting (ASCQR)
Program: For the ASCQR Program, we address the public comments received
as a result of our solicitation in the proposed rule on our approach
for future measure selection and development as well as certain
measures for future potential inclusion in the ASCQR Program measure
set. We are finalizing our approach to future measure selection and
development for the ASCQR Program. For the CY 2015 payment
determination and subsequent years' payment determinations, we are
adopting requirements for claims-based measures regarding the dates for
submission and payment of claims and data completeness. We also are
finalizing our policy regarding how the payment rates will be reduced
in CY 2014 and in subsequent calendar years for ASCs that fail to meet
program requirements, and we are clarifying our policy on updating
measures.
Hospital Outpatient Quality Reporting (OQR) Program: For
the Hospital OQR Program, we are not establishing any new measures for
CY 2013. We also are not specifying any new targeting criteria to
select hospitals for validation of medical records. We are confirming
the removal or suspension of data collection for specific measures. We
are specifying that the criteria we will consider when determining
whether to remove measures for the Hospital Inpatient Quality Reporting
(IQR) Program will also apply to the Hospital OQR Program. We are
providing that measures adopted in future rulemaking are automatically
adopted for all subsequent year payment determinations unless we
remove, suspend, or replace them. We are making changes to
administrative forms used in the program. We are extending the deadline
for submitting a notice of participation form and to enter structural
measures data.
Electronic Health Record (EHR) Incentive Program: For the
EHR Incentive Program, we are extending the 2012 Medicare EHR Incentive
Program Electronic Reporting Pilot for Eligible Hospitals and CAHs
through 2013, exactly as finalized for 2012. We recently issued a final
rule (77 FR 53968) for Stage 2 of the Medicare and Medicaid EHR
Incentive Programs.
Inpatient Rehabilitation Facility Quality Reporting
Program (IRF QRP): We are: (1) Adopting updates on one (out of two)
previously adopted measure for the IRF QRP that will affect annual
prospective payment amounts for FY 2014; (2) adopting a nonrisk-
adjusted version of an NQF-endorsed pressure ulcer measure for the IRF
QRP, and we will not publicly report any pressure ulcer measure data
until we begin risk adjustment of these data; (3) adopting a
[[Page 68217]]
policy that will provide that any measure that has been adopted for use
in the IRF QRP will remain in effect until the measure is actively
removed, suspended, or replaced; and (4) adopting policies regarding
when notice-and-comment rulemaking will be used to update existing IRF
QRP measures.
Revisions to the Quality Improvement Organization (QIO)
Regulations: We are revising the QIO program regulations to: (1) Give
QIOs the authority to send and receive secure transmissions of
electronic versions of medical information; (2) provide more detailed
and improved procedures for QIOs when completing Medicare beneficiary
complaint reviews and general quality of care reviews, including
procedures related to a new alternative dispute resolution process
called ``immediate advocacy''; (3) increase the information
beneficiaries receive in response to QIO review activities; (4) convey
to Medicare beneficiaries the right to authorize the release of
confidential information by QIOs; and (5) make other technical changes
that are designed to improve the regulations. The technical changes to
the QIO regulations that we are making to improve the regulations
reflect CMS' commitment to the principles of the President's Executive
Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).
3. Summary of Costs and Benefits
In sections XXII. and XXIII. of this final rule with comment
period, we set forth a detailed analysis of the regulatory and
federalism impacts that the changes will have on affected entities and
beneficiaries. Key estimated impacts include the following:
a. Impacts of the OPPS Update
(1) Impacts of All OPPS Changes
Table 57 in section XXII. of this final rule with comment period
displays the distributional impact all the OPPS changes on various
groups of hospitals and CMHCs for CY 2013 compared to all estimated
OPPS payments in CY 2012. We estimate that the policies in this final
rule will result in a 1.9 percent overall increase in OPPS payments to
providers. We estimate that the increase in OPPS expenditures,
including beneficiary cost-sharing, will be approximately $600 million,
not taking into account potential changes in enrollment, utilization,
and case-mix. Taking into account estimated spending changes that are
attributable to these factors, we estimate an increase of approximately
$4.571 billion in OPPS expenditures, including beneficiary cost-
sharing, for CY 2013 compared to CY 2012 OPPS expenditures. We estimate
that total OPPS payments, including beneficiary cost-sharing, will be
$48.1 billion for CY 2013.
We estimated the isolated impact of our OPPS policies on CMHCs
because CMHCs are only paid for partial hospitalization services under
the OPPS. Continuing the provider-specific structure that we adopted
for CY 2011 and basing payment fully on the type of provider furnishing
the service, we estimate a 4.4 percent decrease in CY 2013 payments to
CMHCs relative to their CY 2012 payments.
(2) Impacts of Basing APC Relative Payment Weights on Geometric Mean
Costs
We estimate that our final policy to base the APC relative payment
weights on the geometric mean costs rather than the median costs of
services within an APC will not significantly impact most providers.
Payments to very low volume urban hospitals and to hospitals for which
disproportionate share hospital (DSH) data are not available will
increase by an estimated 2.5 and 4.3 percent, respectively. The
hospitals for which DSH data are not available are largely non-IPPS
psychiatric hospitals. In contrast, payments to CMHCs will decrease by
an estimated 3.9 percent due to basing the relative payment weights on
the geometric mean costs of services rather than the median costs of
services.
(3) Impacts of the Updated Wage Indices
We estimate no significant impacts related to updating the wage
indices and applying the frontier State wage index. Adjustments to the
wage indices other than the frontier State wage adjustment will not
significantly affect most hospitals. The updated wage indices will most
affect urban hospitals in the Pacific and East South Central regions
and rural hospitals in the Mountain and Pacific regions.
(4) Impacts of the Rural Adjustment and the Cancer Hospital Payment
Adjustment
There are no significant impacts of our CY 2013 payment policies
for hospitals that are eligible for the rural adjustment or for the
cancer hospital payment adjustment. We are not making any change in
policies for determining the rural and cancer hospital payment
adjustments, and the adjustment amounts do not significantly impact the
budget neutrality adjustments for these policies.
(5) Impacts of the OPD Fee Schedule Increase Factor
We estimate that, for most hospitals, the application of the OPD
fee schedule increase factor of 1.8 percent to the conversion factor
for CY 2013 will mitigate the small negative impacts of the budget
neutrality adjustments. Certain low volume hospitals and hospitals for
which DSH data are not available will experience larger increases
ranging from 4.5 percent to 8.2 percent. As a result of the OPD fee
schedule increase factor and other budget neutrality adjustments, we
estimate that rural and urban hospitals will experience similar
increases of approximately 1.8 percent for urban hospitals and 2.1
percent for rural hospitals. Classifying hospitals by teaching status
or type of ownership suggests that these hospitals will receive similar
increases.
b. Impacts of the ASC Payment Update
For impact purposes, the surgical procedures on the ASC list of
covered procedures are aggregated into surgical specialty groups using
CPT and HCPCS code range definitions. The percentage change in
estimated total payments by specialty groups under the CY 2013 payment
rates compared to estimated CY 2012 payment rates ranges between -3
percent for respiratory system procedures, integumentary system
procedures, and cardiovascular system procedures and 3 percent for
nervous system procedures.
c. Impacts of the Hospital OQR Program
We do not expect our CY 2013 policies to significantly affect the
number of hospitals that do not receive a full annual payment update.
d. Impacts of the EHR Incentive Program Proposal
There are no changes from the 2012 OPPS/ASC final rule to the costs
or impact for the 2013 Medicare EHR Incentive Program Electronic
Reporting Pilot for Hospitals and CAHs.
e. Impacts of the ASCQR Program
We do not expect our CY 2013 final policies to significantly affect
the number of ASCs that do not receive a full annual payment update
beginning in CY 2014.
B. Legislative and Regulatory Authority for the Hospital OPPS
When Title XVIII of the Social Security Act was enacted, Medicare
payment for hospital outpatient services was based on hospital-specific
costs. In an effort to ensure that Medicare and its beneficiaries pay
appropriately for
[[Page 68218]]
services and to encourage more efficient delivery of care, the Congress
mandated replacement of the reasonable cost-based payment methodology
with a prospective payment system (PPS). The Balanced Budget Act of
1997 (BBA) (Pub. L. 105-33) 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 parts 410 and 419.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106-113) made major changes in the hospital OPPS.
The following Acts made additional changes to the OPPS: the Medicare,
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA) (Pub. L. 106-554); the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173); the Deficit
Reduction Act of 2005 (DRA) (Pub. L. 109-171), 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 of 2006 (MIEA-TRHCA)
(Pub. L. 109-432), enacted on December 20, 2006; the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173),
enacted on December 29, 2007; the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), enacted on July
15, 2008; the Patient Protection and Affordable Care Act (Pub. L. 111-
148), enacted on March 23, 2010, as amended by the Health Care and
Education Reconciliation Act of 2010 (Pub. L. 111-152), enacted on
March 30, 2010 (These two public laws are collectively known as the
Affordable Care Act); the Medicare and Medicaid Extenders Act of 2010
(MMEA, Pub. L. 111-309); the Temporary Payroll Tax Cut Continuation Act
of 2011 (TPTCCA, Pub. L. 112-78), enacted on December 23, 2011; and
most recently the Middle Class Tax Relief and Job Creation Act of 2012
(MCTRJCA, Pub. L. 112-96), enacted on February 22, 2012.
Under the OPPS, we pay for hospital outpatient services on a rate-
per-service basis that varies according to the APC group to which the
service is assigned. We use the Healthcare Common Procedure Coding
System (HCPCS) (which includes certain Current Procedural Terminology
(CPT) codes) to identify and group the services within each APC. The
OPPS includes payment for most hospital outpatient services, except
those identified in section I.C. of this final rule with comment
period. Section 1833(t)(1)(B) of the Act provides for payment under the
OPPS for hospital outpatient services designated by the Secretary
(which includes partial hospitalization services furnished by CMHCs),
and certain inpatient hospital services designated by the Secretary
that are furnished to inpatients who are entitled to Part A and have
exhausted their Part A benefits, or who are not so entitled.
The OPPS rate is an unadjusted national payment amount that
includes the Medicare payment and the beneficiary copayment. This rate
is divided into a labor-related amount and a nonlabor-related amount.
The labor-related amount is adjusted for area wage differences using
the 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, items and services within an APC group cannot be
considered comparable with respect to the use of resources if the
highest median cost (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 (or mean cost, if elected by the Secretary) 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 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 pass-through payments,'' for at least 2 but not more
than 3 years for certain drugs, biological agents, brachytherapy
devices used for the treatment of cancer, and categories of other
medical devices. For new technology services that are not eligible for
transitional pass-through payments, and for which we lack sufficient
clinical information and cost data to appropriately assign them to a
clinical APC group, we have established special APC groups based on
costs, which we refer to as New Technology APCs. These New Technology
APCs are designated by cost bands which allow us to provide appropriate
and consistent payment for designated new procedures that are not yet
reflected in our claims data. Similar to pass-through payments, an
assignment to a New Technology APC is temporary; that is, we retain a
service within a New Technology APC until we acquire sufficient data to
assign it to a clinically appropriate APC group.
C. Excluded OPPS Services and Hospitals
Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to
designate the hospital outpatient services that are paid under the
OPPS. While most hospital outpatient services are payable under the
OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for
ambulance, physical and occupational therapy, and speech-language
pathology services, for which payment is made under a fee schedule. It
also excludes screening mammography, diagnostic mammography, and
effective January 1, 2011, an annual wellness visit providing
personalized prevention plan services. 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 MPFS;
laboratory services paid under the Clinical 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 IPPS. We set forth the services that are excluded from payment
under the OPPS in regulations at 42 CFR 419.22.
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; CAHs; hospitals located outside of
the 50 States, the District of Columbia, and Puerto Rico; and Indian
Health Service (IHS) hospitals.
D. 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
[[Page 68219]]
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.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the
Panel), Formerly Named the Advisory Panel on Ambulatory Payment
Classification Groups (APC Panel)
1. Authority of the Panel
Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of
Public Law 106-113, and redesignated by section 202(a)(2) of Public Law
106-113, requires that we consult with an external advisory panel of
experts to annually review the clinical integrity of the payment groups
and their weights under the OPPS. In CY 2000, based on section
1833(t)(9)(A) of the Act and section 222 of the Public Health Service
(PHS) Act, the Secretary established the Advisory Panel on Ambulatory
Payment Classification Groups (APC Panel) to fulfill this requirement.
In CY 2011, based on section 222 of the PHS Act which gives
discretionary authority to the Secretary to convene advisory councils
and committees, the Secretary expanded the panel's scope to include the
supervision of hospital outpatient therapeutic services in addition to
the APC groups and weights. To reflect this new role of the panel, the
Secretary changed the panel's name to the Advisory Panel on Hospital
Outpatient Payment (the HOP Panel, or the Panel). The Panel is not
restricted to using data compiled by CMS, and in conducting its review
it may use data collected or developed by organizations outside the
Department.
2. Establishment of the Panel
On November 21, 2000, the Secretary signed the initial charter
establishing the HOP Panel, at that time named the APC Panel. This
expert panel, which may be composed of up to 19 appropriate
representatives of providers (currently employed full-time, not as
consultants, in their respective areas of expertise), reviews clinical
data and advises CMS about the clinical integrity of the APC groups and
their payment weights. Since CY 2012, the Panel also is charged with
advising the Secretary on the appropriate level of supervision for
individual hospital outpatient therapeutic services. The 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 Panel's charter five times: On November
1, 2002; on November 1, 2004; on November 21, 2006; on November 2, 2008
and November 12, 2010. The current charter specifies, among other
requirements, that: The 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 Official (DFO); and is
chaired by a Federal Official designated by the Secretary. The current
charter was amended on November 15, 2011 and the Panel was renamed to
reflect expanding the Panel's authority to include supervision of
hospital outpatient therapeutic services and therefore to add CAHs to
its membership.
The current Panel membership and other information pertaining to
the 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.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp#TopOfPage.
3. Panel Meetings and Organizational Structure
The Panel has held multiple meetings, with the last meeting taking
place on August 27-28, 2012. Prior to each meeting, we publish a notice
in the Federal Register to announce the meeting and, when necessary, to
solicit nominations for Panel membership and to announce new members.
The Panel has established an operational structure that, in part,
currently includes the use of three subcommittees to facilitate its
required review process. The three current subcommittees are the Data
Subcommittee, the Visits and Observation Subcommittee, and the
Subcommittee for APC Groups and Status Indicator (SI) Assignments
(previously known as the Packaging Subcommittee).
The Data Subcommittee is responsible for studying the data issues
confronting the Panel and for recommending options for resolving them.
The Visits and Observation Subcommittee reviews and makes
recommendations to the Panel on all technical issues pertaining to
observation services and hospital outpatient visits paid under the OPPS
(for example, APC configurations and APC relative payment weights). The
Subcommittee for APC Groups and SI Assignments advises the Panel on the
following issues: The appropriate SIs to be assigned to HCPCS codes,
including but not limited to whether a HCPCS code or a category of
codes should be packaged or separately paid; and the appropriate APC
placement of HCPCS codes regarding services for which separate payment
is made.
Each of these subcommittees was established by a majority vote from
the full Panel during a scheduled Panel meeting, and the Panel
recommended that the subcommittees continue at the August 2012 Panel
meeting. We accepted this recommendation.
Discussions of the other recommendations made by the Panel at the
February 2012 and August 2012 Panel meetings are included in the
sections of this final rule that are specific to each recommendation.
For discussions of earlier Panel meetings and recommendations, we refer
readers to previously published 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.
F. Public Comments Received in Response to the CY 2013 OPPS/ASC
Proposed Rule
We received approximately 668 timely pieces of correspondence on
the CY 2013 PPS/ASC proposed rule that appeared in the Federal Register
on July 30, 2012 (77 FR 45061). We note that we received some public
comments that were outside the scope of the proposed rule and that are
not addressed in this final rule with comment period. Summaries of the
public comments that are within the scope of the proposed rule and our
responses are set forth in the various sections of this final rule with
comment period under the appropriate subject-matter headings.
G. Public Comments Received on the CY 2012 OPPS/ASC Final Rule With
Comment Period
We received approximately 61 timely pieces of correspondence on the
CY 2012 OPPS/ASC final rule with comment period that appeared in the
Federal Register on November 30, 2011 (76 FR 74122), some of which
contained comments on the interim APC assignments and/or status
indicators of HCPCS codes identified with comment indicator ``NI'' in
Addendum B to that final rule. Summaries of these public comments on
topics that were open to comment and our responses to them are set
forth in various sections of this final rule with comment period under
the appropriate subject-matter headings.
[[Page 68220]]
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
1. Database Construction
a. Database Source and Methodology
Section 1833(t)(9)(A) of the Act requires that the Secretary review
not less often than annually and revise the relative payment weights
for APCs. 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.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45071), for the CY
2013 OPPS, we proposed to recalibrate the APC relative payment weights
for services furnished on or after January 1, 2013, and before January
1, 2014 (CY 2013), using the same basic methodology that we described
in the CY 2012 OPPS/ASC final rule with comment period. 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, using the most recent available data to construct a
database for calculating APC group weights. Therefore, for the purpose
of recalibrating the proposed APC relative payment weights for CY 2013,
we used approximately 141 million final action claims (claims for which
all disputes and adjustments have been resolved and payment has been
made) for hospital outpatient department services furnished on or after
January 1, 2011, and before January 1, 2012. For this final rule with
comment period, for the purpose of recalibrating the final APC relative
payment weights for CY 2013, we used approximately 153 million final
action claims (claims for which all disputes and adjustments have been
resolved and payment has been made) for HOPD services furnished on or
after January 1, 2011, and before January 1, 2012. For exact counts of
claims used, we refer readers to the claims accounting narrative under
supporting documentation for the proposed rule and this final rule with
comment period on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
Of the approximately 153 million final action claims for services
provided in hospital outpatient settings used to calculate the final CY
2013 OPPS payment rates for this final rule with comment period,
approximately 121 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
approximately 121 million claims, approximately 5 million claims were
not for services paid under the OPPS or were excluded as not
appropriate for use (for example, erroneous cost-to-charge ratios
(CCRs) or no HCPCS codes reported on the claim). From the remaining
approximately 116 million claims, we created approximately 120 million
single records, of which approximately 81 million were ``pseudo''
single or ``single session'' claims (created from approximately 39
million multiple procedure claims using the process we discuss later in
this section). Approximately 1 million claims were trimmed out on cost
or units in excess of 3 standard deviations from the
geometric mean, yielding approximately 120 million single bills for
ratesetting. 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
payment 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 procedure claims (as defined below), 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 2013
ratesetting some portion of approximately 95 percent of the CY 2011
claims containing services payable under the OPPS.
The final APC relative weights and payments for CY 2013 in Addenda
A and B to this final rule with comment period (which are available via
the Internet on the CMS Web site) were calculated using claims from CY
2011 that were processed through June 30, 2012. While we have
historically based the payments on median hospital costs for services
in the APC groups, we proposed in the CY 2013 OPPS/ASC proposed rule
(77 FR 45071) to establish the cost-based relative payment weights of
the CY 2013 OPPS using geometric mean costs, as discussed in section
II.A.2.f. of this final rule with comment period. Therefore, on the CMS
Web site, along with Addenda A and B, we provided a file that presented
payment information for the proposed CY 2013 OPPS payments based on
geometric mean costs compared to those based on median costs. Under
this methodology, we select claims for services paid under the OPPS and
match 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 relative costs underpinning the APC relative payment
weights and the CY 2013 payment rates.
b. Use of Single and Multiple Procedure Claims
For CY 2013, in general, we proposed to continue to use single
procedure claims to set the costs on which the APC relative payment
weights are based. We generally use single procedure claims to set the
estimated 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 unit of 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.
It is generally 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
proposed to continue 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 procedure 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
procedure claims. The history of our use of a bypass list to generate
``pseudo'' single procedure claims is well documented, most recently in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74132
through 74134). In addition, for CY 2008 (72 FR 66614 through 66664),
we increased packaging and created the first composite APCs, and
continued
[[Page 68221]]
those policies through CY 2012. Increased packaging and creation of
composite APCs also increased the number of bills that we were able to
use for ratesetting 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 in developing the OPPS relative weights on which payments are
based. We have continued the composite APCs for multiple imaging
services through CY 2012. We did not receive any public comments on
this policy, and therefore, we are finalizing our proposal to continue
this policy for CY 2013. We refer readers to section II.A.2.e. of this
final rule with comment period for a discussion of the use of claims in
modeling the costs for composite APCs.
We proposed to continue to apply these processes to enable us to
use as much claims data as possible for ratesetting for the CY 2013
OPPS. This methodology enabled us to create, for this final rule with
comment period, approximately 81 million ``pseudo'' single procedure
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 39
million ``natural'' single procedure claims. For this final rule with
comment period, ``pseudo'' single procedure and ``single session''
procedure bills represented approximately 67 percent of all single
procedure bills used for ratesetting purposes.
For CY 2013, we proposed to bypass 480 HCPCS codes that were
identified in Addendum N to the CY 2013 OPPS/ASC proposed rule (which
was available via the Internet on the CMS Web site). Since the
inception of the bypass list, which is the list of codes to be bypassed
to convert multiple procedure claims to ``pseudo'' single procedure
claims, 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 updated
year's data (for CY 2013, data available for the February 27, 2012
meeting of the Advisory Panel on Hospital Outpatient Payment (the
Panel) from CY 2011 claims processed through September 30, 2011, and CY
2010 claims data processed through June 30, 2011, used to model the
payment rates for CY 2012) to determine whether it would be appropriate
to add additional codes to the previous year's bypass list. For CY
2013, we proposed to continue to bypass all of the HCPCS codes on the
CY 2012 OPPS bypass list, with the exception of HCPCS codes that we
proposed to delete for CY 2013, which are listed in Table 1 of the
proposed rule. We also proposed to remove HCPCS codes that are not
separately paid under the OPPS because the purpose of the bypass list
is to obtain more data for those codes relevant to ratesetting. In
addition, we proposed to add to the bypass list for CY 2013 HCPCS codes
not on the CY 2012 bypass list that, using either the CY 2012 final
rule data (CY 2010 claims) or the February 27, 2012 Panel data (first 9
months of CY 2011 claims), met the empirical criteria for the bypass
list that are summarized below. Finally, to remain consistent with the
CY 2013 final policy to develop OPPS relative payment weights based on
geometric mean costs, we proposed that the median cost of packaging
criterion instead be based on the geometric mean cost of packaging. The
entire list proposed for CY 2013 (including the codes that remain on
the bypass list from prior years) was open to public comment in the CY
2013 OPPS/ASC proposed rule. 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 assumed that the
representation of packaging on ``natural'' single procedure claims for
any given code is comparable to packaging for that code in the multiple
procedure claims. As we proposed, the criteria for the bypass list are:
There are 100 or more ``natural'' single procedure claims
for the code. This number of single procedure claims ensures that
observed outcomes are sufficiently representative of packaging that
might occur in the multiple claims.
Five percent or fewer of the ``natural'' single procedure
claims for the code have packaged costs on that single procedure claim
for the code. This criterion results in limiting the amount of
packaging being redistributed to the separately payable procedures
remaining on the claim after the bypass code is removed and ensures
that the costs associated with the bypass code represent the cost of
the bypassed service.
The geometric mean cost of packaging observed in the
``natural'' single procedure claims is equal to or less than $55. This
criterion also limits the amount of error in redistributed costs.
During the assessment of claims against the bypass criteria, we do not
know the dollar value of the packaged cost that should be appropriately
attributed to the other procedures on the claim. Therefore, ensuring
that redistributed costs associated with a bypass code are small in
amount and volume protects the validity of cost estimates for low cost
services billed with the bypassed service.
We note that, in the CY 2013 OPPS/ASC proposed rule (77 FR 45072),
we proposed to establish the CY 2013 OPPS relative payment weights
based on geometric mean costs. To remain consistent in the metric used
for identifying cost patterns, we proposed to use the geometric mean
cost of packaging to identify potential codes to add to the bypass
list. The development of the CY 2013 OPPS relative payment weights
based on geometric mean costs is discussed in greater detail in section
II.A.2.f. of this final rule with comment period.
In response to public comments on the CY 2010 OPPS/ASC proposed
rule requesting that the packaged cost threshold be updated, we
considered whether it would be appropriate to update the $50 packaged
cost threshold for inflation when examining potential bypass list
additions. As discussed in the CY 2010 OPPS/ASC final rule with comment
period (74 FR 60328), the real value of this packaged cost threshold
criterion has declined due to inflation, making the packaged cost
threshold more restrictive over time when considering additions to the
bypass list. Therefore, adjusting the threshold by the market basket
increase would prevent continuing decline in the threshold's real
value. Based on the same rationale described for the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74133), we proposed for CY 2013
to continue to update the packaged cost threshold by the market basket
increase. By applying the final CY 2012 market basket increase of 1.9
percent to the prior non-rounded dollar threshold of $52.76 (76 FR
74133), we determined that the threshold remains for CY 2013 at $55
($53.76 rounded to $55, the nearest $5 increment). Therefore, we
proposed to set the geometric mean packaged cost threshold on the CY
2011 claims at $55 for a code to be considered for addition to the CY
2013 OPPS bypass list.
The code is not a code for an unlisted service. Unlisted
codes do not describe a specific service, and thus their costs would
not be appropriate for bypass list purposes.
In addition, we proposed to continue to include on the bypass list
HCPCS codes that CMS medical advisors
[[Page 68222]]
believe have minimal associated packaging based on their clinical
assessment of the complete CY 2013 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. We also proposed to continue to
include certain HCPCS codes on the bypass list 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 procedure 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, the program logic for creating ``pseudo''
single procedure claims from bypassed codes that are also members of
multiple imaging composite APCs changed. When creating the set of
``pseudo'' single procedure claims, claims that contain ``overlap
bypass codes'' (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 procedure claims. (We refer readers to section
II.A.2.b. of this final rule with comment period 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 costs. ``Overlap bypass codes''
that are members of the multiple imaging composite APCs are identified
by asterisks (*) in Addendum N to this final rule with comment period
(which is available via the Internet on the CMS Web site).
Addendum N to this final rule with comment period includes the list
of bypass codes for CY 2013. The list of bypass codes contains codes
that were reported on claims for services in CY 2011 and, therefore,
includes codes that were in effect in 2011 and used for billing but
were deleted for CY 2012. We retained these deleted bypass codes on the
CY 2013 bypass list because these codes existed in CY 2011 and were
covered OPD services in that period, and CY 2011 claims data are used
to calculate CY 2013 payment rates. Keeping these deleted bypass codes
on the bypass list potentially allows us to create more ``pseudo''
single procedure claims for ratesetting purposes. ``Overlap bypass
codes'' that were members of the proposed multiple imaging composite
APCs are identified by asterisks (*) in the third column of Addendum N
to this final rule with comment period. HCPCS codes that we are adding
for CY 2013 are identified by asterisks (*) in the fourth column of
Addendum N. Table 1 of the proposed rule contained the list of codes
that we proposed to remove from the CY 2013 bypass list for CY 2013 (77
FR 45073).
Comment: One commenter supported the proposal to include CPT codes
76881 (Ultrasound, extremity, nonvascular, real-time with image
documentation; complete) and 76882 (Ultrasound, extremity, nonvascular,
real-time with image documentation; limited, anatomic specific) on the
CY 2013 OPPS bypass list.
Response: We appreciate the commenter's support.
Comment: Several commenters expressed appreciation for our efforts
to include multiple procedure claims in the ratesetting process through
processes such as the bypass list and date of service stratification,
which are used to create ``pseudo'' single claims. However, the
commenters remained concerned about the limited number of claims used
to model brachytherapy APCs 0312 (Radioelement Applications), 0651
(Complex Interstitial Radiation Source Application), and 8001 (LDR
Prostate Brachytherapy Composite) and encouraged CMS to continue
exploring potential methodologies through which more claims data could
be used in OPPS ratesetting.
Response: We appreciate the commenters' support of our efforts to
include more appropriate claims data for ratesetting purposes. As
discussed above, one of the challenges in modeling the APC costs on
which the OPPS/ASC relative payment weights are based is appropriately
allocating the packaged cost associated with a service, when multiple
separately payable procedures appear on the claim. However, recognizing
the challenges associated with obtaining additional information, we
will continue to explore potential methodologies through which we would
be able to derive accurate cost data from the multiple major procedure
claims made available to us.
After consideration of the public comments we received, we are
adopting as final the proposed ``pseudo'' single claims process and the
final CY 2013 bypass list of 480 HCPCS codes, as displayed in Addendum
N of this final rule with comment period (available via the Internet on
the CMS Web site). Table 1 below contains the list of codes that we are
removing from the CY 2013 bypass list because these codes were either
deleted from the HCPCS before CY 2011 (and therefore were not covered
OPD services in CY 2011) or were not separately payable codes under the
CY 2013 OPPS because these codes are not used for ratesetting (and
therefore would not need to be bypassed). None of these deleted codes
are ``overlap bypass'' codes.
[[Page 68223]]
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c. Calculation and Use of Cost-to-Charge Ratios (CCRs)
In the CY 2013 OPPS/ASC proposed rule (77 FR 45073), for CY 2013,
we proposed to continue to use the hospital-specific overall ancillary
and departmental cost-to-charge ratios (CCRs) to convert charges to
estimated costs through application of a revenue code-to-cost center
crosswalk. To calculate the APC costs on which the proposed CY 2013 APC
payment rates were based, we calculated hospital-specific overall
ancillary CCRs and hospital-specific departmental CCRs for each
hospital for which we had CY 2011 claims data from the most recent
available hospital cost reports, in most cases, cost reports beginning
in CY 2010. For the CY 2013 OPPS proposed rates, we used the set of
claims processed during CY 2011. We applied the hospital-specific CCR
to the hospital's charges at the most detailed level possible, based on
a revenue code-to-cost center crosswalk that contains a hierarchy of
CCRs used to estimate costs from charges for each revenue code. That
crosswalk is available for review and continuous comment on the CMS Web
site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
To ensure the completeness of the revenue code-to-cost center
crosswalk, we reviewed changes to the list of revenue codes for CY 2011
(the year of the claims data we used to calculate the proposed CY 2013
OPPS payment rates) and found that the National Uniform Billing
Committee (NUBC) did not add any new revenue codes to the NUBC 2011
Data Specifications Manual.
In accordance with our longstanding policy, we calculated CCRs for
the standard and nonstandard cost centers accepted by the electronic
cost report database. In general, the most detailed level at which we
calculated CCRs was the hospital-specific departmental level. For a
discussion of the hospital-specific overall ancillary CCR calculation,
we refer readers to the CY 2007 OPPS/ASC final rule with comment period
(71 FR 67983 through 67985). One longstanding exception to this general
methodology for calculation of CCRs used for converting charges to
costs on each claim, as detailed in the CY 2007 OPPS/ASC final rule
with comment period, is the calculation of blood costs, as discussed in
section II.A.2.d.(2) of this final rule with comment period and which
has been our standard policy since the CY 2005 OPPS.
For the CCR calculation process, we used the same general approach
that we used in developing the final APC rates for CY 2007 and
thereafter, using the revised CCR calculation that excluded the costs
of paramedical education programs and weighted the outpatient charges
by the volume of outpatient services furnished by the hospital. We
refer readers to the CY 2007 OPPS/ASC final rule with comment period
for more information (71 FR 67983 through 67985). We first limited the
population of cost reports to only those hospitals that filed
outpatient claims in CY 2011 before determining whether the CCRs for
such hospitals were valid.
We then calculated the CCRs for each cost center and the overall
ancillary CCR for each hospital for which we had claims data. We did
this using hospital-specific data from the Hospital Cost Report
Information System (HCRIS). We used the most recent available cost
report data, in most cases, cost reports with cost reporting periods
beginning in CY 2010. For the proposed rule, we used the most recently
submitted cost reports to calculate the CCRs to be used to calculate
costs for the proposed CY 2013 OPPS payment rates. If the most recently
available cost report was submitted but not settled, we looked at the
last settled cost report to determine the ratio of submitted to settled
cost using the overall ancillary CCR, and we then adjusted the most
recent available submitted, but not settled, cost report using that
ratio. We then calculated both an overall ancillary CCR and cost
center-specific CCRs for each hospital. We used the overall ancillary
CCR referenced above for all purposes that require use of an overall
ancillary CCR. We proposed to continue this longstanding methodology
for the calculation of costs for CY 2013.
Since the implementation of the OPPS, some commenters have raised
concerns about potential bias in the OPPS cost-based weights due to
``charge compression,'' which is the practice of applying a lower
charge markup to higher cost services and a higher charge markup to
lower cost services. As a result, the cost-based weights may reflect
some aggregation bias, undervaluing high-cost items and overvaluing
low-cost items when an estimate of average markup, embodied in a single
CCR, is applied to items of widely varying costs in the same cost
center. This issue was evaluated in a report by Research Triangle
Institute, International (RTI). The RTI final report can be found on
RTI's Web site at: http://www.rti.org/reports/cms/HHSM-500-2005-0029I/PDF/Refining_Cost_to_Charge_Ratios_200807_Final.pdf. For a
complete discussion of the RTI recommendations, public comments, and
our responses, we refer readers to the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68519 through 68527).
We addressed the RTI finding that there was aggregation bias in
both the IPPS and the OPPS cost estimation of expensive and inexpensive
medical supplies in the FY 2009 IPPS final rule (73 FR 48458 through
45467). Specifically, we created one cost center for ``Medical Supplies
Charged to Patients'' and one cost center for ``Implantable Devices
Charged to Patients,'' essentially splitting the then current cost
center for ``Medical
[[Page 68224]]
Supplies Charged to Patients'' into one cost center for low-cost
medical supplies and another cost center for high-cost implantable
devices in order to mitigate some of the effects of charge compression.
In determining the items that should be reported in these respective
cost centers, we adopted commenters' recommendations that hospitals
should use revenue codes established by the AHA's NUBC to determine the
items that should be reported in the ``Medical Supplies Charged to
Patients'' and the ``Implantable Devices Charged to Patients'' cost
centers. For a complete discussion of the rationale for the creation of
the new cost center for ``Implantable Devices Charged to Patients,''
public comments, and our responses, we refer readers to the FY 2009
IPPS final rule.
The cost center for ``Implantable Devices Charged to Patients'' has
been available for use for cost reporting periods beginning on or after
May 1, 2009. As discussed in the CY 2013 OPPS/ASC proposed rule (77 FR
45074), in order to develop a robust analysis regarding the use of cost
data from the ``Implantable Devices Charged to Patients'' cost center,
we believe that it is necessary to have a critical mass of cost reports
filed with data in this cost center. In preparation for the CY 2013
proposed rule, we assessed the availability of data in the
``Implantable Devices Charged to Patients'' cost center using cost
reports in the December 31, 2011 quarter ending update of HCRIS, which
was the latest upload of the cost report data that we could use for the
CY 2013 proposed rule. We determined that 2,063 hospitals, out of
approximately 3,800 hospitals, utilized the ``Implantable Devices
Charged to Patients'' cost center. Because we believe that this is a
sufficient amount of data from which to generate a meaningful analysis,
we proposed to use data from the ``Implantable Devices Charged to
Patients'' cost center to create a distinct CCR for use in calculating
the OPPS relative payment weights for CY 2013.
In the FY 2011 IPPS/LTCH PPS final rule (75 FR 50075 through
50080), we finalized our proposal to create new standard cost centers
for ``Computed Tomography (CT),'' ``Magnetic Resonance Imaging (MRI),''
and ``Cardiac Catheterization,'' and to require that hospitals report
the costs and charges for these services under new cost centers on the
revised Medicare cost report Form CMS 2552-10. As we discussed in the
FY 2009 IPPS and CY 2009 OPPS/ASC proposed and final rules, RTI also
found that the costs and charges of CT scans, MRIs, and cardiac
catheterization differ significantly from the costs and charges of
other services included in the standard associated cost center. RTI
concluded that both the IPPS and the OPPS relative payment weights
would better estimate the costs of those services if CMS were to add
standard costs centers for CT scans, MRIs, and cardiac catheterization
in order for hospitals to report separately the costs and charges for
those services and in order for CMS to calculate unique CCRs to
estimate the cost from charges on claims data. We refer readers to the
FY 2011 IPPS/LTCH PPS final rule (75 FR 50075 through 50080) for a more
detailed discussion on the reasons for the creation of standard cost
centers for CT scans, MRIs, and cardiac catheterization. The new
standard cost centers for CT scans, MRIs, and cardiac catheterization
are effective for cost report periods beginning on or after May 1,
2010, on the revised cost report Form CMS-2552-10. However, because
cost reports that were filed on the revised cost report Form CMS-2552-
10 are not currently accessible in the HCRIS, we were unable to
calculate distinct CCRs for CT scans, MRIs, and cardiac catheterization
using the new standard cost centers for these services. We believe that
we will have cost report data available for an analysis of creating
distinct CCRs for CT scans, MRIs, and cardiac catheterization for the
CY 2014 OPPS rulemaking.
Comment: Many commenters supported CMS' proposal to use data from
the ``Implantable Devices Charged to Patients'' cost center to create a
distinct CCR for use in calculating the OPPS relative payment weights
for CY 2013. The commenters also encouraged CMS to continue to engage
in educational efforts related to the use of the new cost center so
that hospitals understand how to accurately report data in the new cost
center. In addition, the commenters suggested that the Medicare
administrative contractors (MACs) develop an audit program that would
identify hospitals that have not reported data for the new cost center.
Response: We appreciate the commenters' support of our proposal to
use data from the ``Implantable Devices Charged to Patients'' cost
center to create a distinct CCR. We agree with commenters that it is
important that hospitals understand how to accurately report data in
the ``Implantable Devices Charged to Patients'' cost center, and we
have worked to add more clarity to the cost report instructions under
the new Medicare cost report form CMS-2552-10. The new cost report form
also facilitates greater audit scrutiny from the MACs. Line 121 of
Worksheet S-2, Part I, of cost report form CMS-2552-10 asks ``Did this
facility incur and report costs for implantable devices charged to a
patient? Enter in column 1 `Y' for yes and `N' for no.''
Comment: Two commenters recommended that CMS wait until CY 2014
OPPS rulemaking to determine if the ``Implantable Devices Charged to
Patients'' cost center should be used to create a distinct CCR. The
commenters did not believe that data from 2,063 hospitals provide a
meaningful representation of all of the hospitals subject to the OPPS
from which to base the proposal to use the new cost center for CY 2013.
Response: We disagree with the commenters and believe that data
from the 2,063 hospitals that utilized the ``Implantable Devices
Charged to Patients'' cost center, out of approximately 3,800
hospitals, are sufficient and appropriate for creating a distinct CCR
to use in the calculation of the CY 2013 OPPS relative payment weights.
Comment: Commenters expressed disappointment that, because the
revised cost report Form CMS-2552-10 was not accessible in the HCRIS at
the time of the proposed rule, CMS was not able to create distinct CCRs
for CT scans, MRIs, and cardiac catheterization services for use in the
calculation of the CY 2013 OPPS relative payment weights. The
commenters urged CMS to analyze the data in the new CT scan, MRI, and
cardiac catheterization cost centers when the data are available and
utilize the new cost centers in the development of the OPPS relative
payment weights as soon as possible.
Response: We expect that we will have sufficient and appropriate
cost report data available for an analysis of creating distinct CCRs
for CT scans, MRIs, and cardiac catheterization for the CY 2014
rulemaking. If so, as was done for the ``Implantable Devices Charged to
Patients'' cost center for the CY 2013 OPPS/ASC proposed rule, we
expect to provide an impact analysis in the CY 2014 OPPS/ASC proposed
rule that will enable the public to assess the full impact of the use
of the new CCRs specific to CT scans, MRIs, and cardiac catheterization
on payments for all services.
Comment: One commenter recommended that CMS require the use of the
new nonstandard cost center for cardiac rehabilitation instead of
making its use optional.
Response: We created the new nonstandard cost center for cardiac
rehabilitation because we believed that
[[Page 68225]]
this would facilitate more accurate cost reporting for these services.
The nonstandard cost centers are additional common cost centers
available to hospitals for reporting when preparing their Medicare
hospital cost report. To the extent hospitals provide services captured
by nonstandard cost centers, they should report the relevant
nonstandard cost centers as well. However, we do not specify a revenue
code-to-cost center crosswalk that hospitals must adopt to prepare the
cost report and, therefore, we do not believe that we should require
hospitals to use the nonstandard cost center for cardiac
rehabilitation.
After consideration of the public comments we received, we are
finalizing our proposal to use data from the ``Implantable Devices
Charged to Patients'' cost center to create a distinct CCR for use in
calculating the OPPS relative payment weights for CY 2013.
2. Data Development Process and Calculation of Costs Used for
Ratesetting
In this section of this final rule with comment period, we discuss
the use of claims to calculate OPPS payment rates for CY 2013. The
Hospital OPPS page on the CMS Web site on which this final rule with
comment period is posted (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html) provides an
accounting of claims used in the development of the final payment
rates. That accounting provides additional detail regarding the number
of claims derived at each stage of the process. In addition, below in
this section we discuss the file of claims that comprises the data set
that is available for purchase under a CMS data use agreement. The CMS
Web site, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html, includes information about purchasing
the ``OPPS Limited Data Set,'' which now includes the additional
variables previously available only in the OPPS Identifiable Data Set,
including ICD-9-CM diagnosis codes and revenue code payment amounts.
This file is derived from the CY 2011 claims that were used to
calculate the final payment rates for the CY 2013 OPPS.
In the history of the OPPS, we have traditionally established the
scaled relative weights on which payments are based using APC median
costs, which is a process most recently described in the CY 2012 OPPS/
ASC final rule with comment period (76 FR 74188). However, as discussed
in more detail in section II.A.2.f. of this final rule with comment
period, we proposed to use geometric mean costs to calculate the
relative weights on which the CY 2013 OPPS payment rates are based.
While this policy changes the cost metric on which the relative
payments are based, the data process in general remains the same, under
the methodologies that we use to obtain appropriate claims data and
accurate cost information in determining estimated service cost.
We used the methodology described in sections II.A.2.a. through
II.A.2.e. of this final rule with comment period to calculate the costs
we used to establish the relative weights used in calculating the OPPS
payment rates for CY 2013 shown in Addenda A and B to this final rule
with comment period (which are available via the Internet on the CMS
Web site). For the proposed rule, we provided a comparison file so that
the public could provide meaningful comment on our proposal to base the
CY 2013 OPPS relative payment weights on geometric mean costs. We refer
readers to section II.A.4. of this final rule with comment period for a
discussion of the conversion of APC costs to scaled payment weights.
Comment: Commenters expressed concern with respect to the
volatility of the OPPS payment rates from year to year. The commenters
suggested a ``stability policy'' and suggested that the costs from
claims be adjusted to limit changes from year to year and asked that
CMS limit any decreases in payment compared to the prior year to no
more than a 5-percent decline.
Response: As previously discussed in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74139), there are a number of factors
that contribute to cost fluctuations from one year to the next,
including (but not limited to) hospital behavior in adjusting mix of
services, hospital costs and charges changes each year resulting in
changes to the CCRs, reassignments of HCPCS codes, changes to OPPS
payment policy (for example, changes to packaging), and implementation
of composite APCs. We cannot stabilize hospital-driven fundamental
inputs to the calculation of OPPS payment rates. However, we have
strived to resolve some of the other potential reasons for instability
from year to year. Specifically, we continue to seek ways to use more
claims data so that we have fewer APCs for which there are small
numbers of single bills used to set the APC costs. Moreover, we have
tried to eliminate APCs with very small numbers of single bills where
we could do so. We recognize that changes to payment policies, such as
the packaging of payment for ancillary and supportive services and the
implementation of composite APCs, may contribute to volatility in
payment rates in the short term. However, we believe that larger
payment packages and bundles should help to stabilize payments in the
long term by enabling us to use more claims data and by establishing
payments for larger groups of services. Further, in seeking to mitigate
fluctuations in the OPPS, we believe that implementing the policy
suggested by the commenters would make payments less reflective of the
true service costs, which would be contrary to a purpose of our
proposed CY 2013 policy of establishing relative payment weights based
on geometric mean costs. Limiting decreases to payments across all APCs
in a budget neutral payment system could unfairly reduce the payments
for other services due to the effects of the scaling that is necessary
to maintain budget neutrality and would distort the relativity of
payment that is based on the cost of all services.
a. Claims Preparation
For this final rule with comment period, we used the CY 2011
hospital outpatient claims processed through June 30, 2012, to
calculate the geometric mean costs of APCs that underpin the relative
payment weights for CY 2013. To begin the calculation of the relative
payment weights for CY 2013, we pulled all claims for outpatient
services furnished in CY 2011 from the national claims history file.
This is not the population of claims paid under the OPPS, but all
outpatient claims (including, for example, critical access hospital
(CAH) claims and hospital claims for clinical laboratory services for
persons who are neither inpatients nor outpatients of the hospital).
We then excluded claims with condition codes 04, 20, 21, and 77
because these are claims that providers submitted to Medicare knowing
that no payment would be made. For example, providers submit claims
with a condition code 21 to elicit an official denial notice from
Medicare and document that a service is not covered. We then excluded
claims for services furnished in Maryland, Guam, the U.S. Virgin
Islands, American Samoa, and the Northern Mariana Islands because
hospitals in those geographic areas are not paid under the OPPS, and,
therefore, we do not use claims for services furnished in these areas
in ratesetting.
We divided the remaining claims into the three groups shown below.
Groups 2 and 3 comprise the 121 million claims that contain hospital
bill types paid under the OPPS.
1. Claims that were not bill types 12X (Hospital Inpatient
(Medicare Part B
[[Page 68226]]
only)), 13X (Hospital Outpatient), 14X (Hospital--Laboratory Services
Provided to Nonpatients), or 76X (Clinic--Community Mental Health
Center). Other bill types are not paid under the OPPS; therefore, these
claims were not used to set OPPS payment.
2. Claims that were bill types 12X, 13X or 14X. Claims with bill
types 12X and 13X are hospital outpatient claims. Claims with bill type
14X are laboratory specimen claims, of which we use a subset for the
limited number of services in these claims that are paid under the
OPPS.
3. Claims that were bill type 76X (CMHC).
To convert charges on the claims to estimated cost, we multiplied
the charges on each claim by the appropriate hospital-specific CCR
associated with the revenue code for the charge as discussed in section
II.A.1.c. of this final rule with comment period. We then flagged and
excluded CAH claims (which are not paid under the OPPS) and claims from
hospitals with invalid CCRs. The latter included claims from hospitals
without a CCR; those from hospitals paid an all-inclusive rate; those
from hospitals with obviously erroneous CCRs (greater than 90 or less
than 0.0001); and those from hospitals with overall ancillary CCRs that
were identified as outliers (that exceeded 3 standard
deviations from the geometric mean after removing error CCRs). In
addition, we trimmed the CCRs at the cost center (that is,
departmental) level by removing the CCRs for each cost center as
outliers if they exceeded 3 standard deviations from the
geometric mean. We used a four-tiered hierarchy of cost center CCRs,
which is the revenue code-to-cost center crosswalk, to match a cost
center to every possible revenue code appearing in the outpatient
claims that is relevant to OPPS services, with the top tier being the
most common cost center and the last tier being the default CCR. If a
hospital's cost center CCR was deleted by trimming, we set the CCR for
that cost center to ``missing'' so that another cost center CCR in the
revenue center hierarchy could apply. If no other cost center CCR could
apply to the revenue code on the claim, we used the hospital's overall
ancillary CCR for the revenue code in question as the default CCR. For
example, if a visit was reported under the clinic revenue code but the
hospital did not have a clinic cost center, we mapped the hospital-
specific overall ancillary CCR to the clinic revenue code. The revenue
code-to-cost center crosswalk is available for inspection on the CMS
Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Revenue codes that we do not
use in establishing relative costs or to model impacts are identified
with an ``N'' in the revenue code-to-cost center crosswalk.
We applied the CCRs as described above to claims with bill type
12X, 13X, or 14X, excluding all claims from CAHs and hospitals in
Maryland, Guam, the U.S. Virgin Islands, American Samoa, and the
Northern Mariana Islands and claims from all hospitals for which CCRs
were flagged as invalid.
We identified claims with condition code 41 as partial
hospitalization services of hospitals and moved them to another file.
We note that the separate file containing partial hospitalization
claims is included in the files that are available for purchase as
discussed above.
We then excluded claims without a HCPCS code. We moved to another
file claims that contained only influenza and pneumococcal pneumonia
(PPV) vaccines. Influenza and PPV vaccines are paid at reasonable cost;
therefore, these claims are not used to set OPPS rates.
We next copied line-item costs for drugs, blood, and brachytherapy
sources to a separate file (the lines stay on the claim, but are copied
onto another file). No claims were deleted when we copied these lines
onto another file. These line-items are used to calculate a per unit
arithmetic and geometric mean and median cost and a per day arithmetic
and geometric mean and median cost for drugs and nonimplantable
biologicals, therapeutic radiopharmaceutical agents, and brachytherapy
sources, as well as other information used to set payment rates, such
as a unit-to-day ratio for drugs.
In the past several years, we have developed payment policy for
nonpass-through separately paid drugs and biologicals based on a
redistribution methodology that accounts for pharmacy overhead by
allocating cost from packaged drugs to separately paid drugs. This
typically would have required us to reduce the cost associated with
packaged coded and uncoded drugs in order to allocate that cost.
However, for CY 2013, as we proposed, we are paying for separately
payable drugs and biologicals under the OPPS at ASP + 6 percent, based
upon the statutory default described in section 1833(t)(14)(A)(iii)(II)
of the Act. Therefore, under this policy, we do not redistribute the
packaged cost. We refer readers to section V.B.3. of this final rule
with comment period for a complete discussion of our policy to pay for
separately paid drugs and biologicals in CY 2013.
We then removed line-items that were not paid during claim
processing, presumably for a line-item rejection or denial. The number
of edits for valid OPPS payment in the Integrated Outpatient Code
Editor (I/OCE) and elsewhere has grown significantly in the past few
years, especially with the implementation of the full spectrum of
National Correct Coding Initiative (NCCI) edits. To ensure that we are
using valid claims that represent the cost of payable services to set
payment rates, we removed line-items with an OPPS status indicator that
were not paid during claims processing in the claim year, but have a
status indicator of ``S,'' ``T,'' ``V,'' or ``X'' in the prospective
year's payment system. This logic preserves charges for services that
would not have been paid in the claim year but for which some estimate
of cost is needed for the prospective year, such as services newly
removed from the inpatient list for CY 2012 that were assigned status
indicator ``C'' in the claim year. It also preserves charges for
packaged services so that the costs can be included in the cost of the
services with which they are reported, even if the CPT codes for the
packaged services were not paid because the service is part of another
service that was reported on the same claim or the code otherwise
violates claims processing edits.
For CY 2013, as we proposed, we are continuing the policy we
implemented for CY 2012 to exclude line-item data for pass-through
drugs and biologicals (status indicator ``G'' for CY 2011) and nonpass-
through drugs and biologicals (status indicator ``K'' for CY 2011)
where the charges reported on the claim for the line were either denied
or rejected during claims processing. Removing lines that were eligible
for payment but were not paid ensures that we are using appropriate
data. The trim avoids using cost data on lines that we believe were
defective or invalid because those rejected or denied lines did not
meet the Medicare requirements for payment. For example, edits may
reject a line for a separately paid drug because the number of units
billed exceeded the number of units that would be reasonable and,
therefore, is likely a billing error (for example, a line reporting 55
units of a drug for which 5 units is known to be a fatal dose). As with
our trimming in the CY 2012 OPPS/ASC final rule with comment period (76
FR 74141) of line-items with a status indicator of ``S,'' ``T,'' ``V,''
or ``X,'' we believe that unpaid line-items represent services that are
invalidly reported and, therefore, should not be
[[Page 68227]]
used for ratesetting. We believe that removing lines with valid status
indicators that were edited and not paid during claims processing
increases the accuracy of the data used for ratesetting purposes.
b. Splitting Claims and Creation of ``Pseudo'' Single Procedure Claims
(1) Splitting Claims
For the CY 2013 OPPS, we then split the remaining claims into five
groups: single majors; multiple majors; single minors; multiple minors;
and other claims. (Specific definitions of these groups are presented
below.) For CY 2013, as we proposed, we are continuing our current
policy of defining major procedures as any HCPCS code having a status
indicator of ``S,'' ``T,'' ``V,'' or ``X''; defining minor procedures
as any code having a status indicator of ``F,'' ``G,'' ``H,'' ``K,''
``L,'' ``R,'' ``U,'' or ``N'':and classifying ``other'' procedures as
any code having a status indicator other than one that we have
classified as major or minor. For CY 2013, as we proposed, we are
continuing to assign status indicator ``R'' to blood and blood
products; status indicator ``U'' to brachytherapy sources; status
indicator ``Q1'' to all ``STVX-packaged codes''; status indicator
``Q2'' to all ``T-packaged codes''; and status indicator ``Q3'' to all
codes that may be paid through a composite APC based on composite-
specific criteria or paid separately through single code APCs when the
criteria are not met.
As discussed in the CY 2009 OPPS/ASC final rule with comment period
(73 FR 68709), we established status indicators ``Q1,'' ``Q2,'' and
``Q3'' to facilitate identification of the different categories of
codes. As we proposed, we are treating these codes in the same manner
for data purposes for CY 2013 as we have treated them since CY 2008.
Specifically, we are continuing to evaluate whether the criteria for
separate payment of codes with status indicator ``Q1'' or ``Q2'' are
met in determining whether they are treated as major or minor codes.
Codes with status indicator ``Q1'' or ``Q2'' are carried through the
data either with status indicator ``N'' as packaged or, if they meet
the criteria for separate payment, they are given the status indicator
of the APC to which they are assigned and are considered as ``pseudo''
single procedure claims for major codes. Codes assigned status
indicator ``Q3'' are paid under individual APCs unless they occur in
the combinations that qualify for payment as composite APCs and,
therefore, they carry the status indicator of the individual APC to
which they are assigned through the data process and are treated as
major codes during both the split and ``pseudo'' single creation
process. The calculation of the geometric mean costs for composite APCs
from multiple procedure major claims is discussed in section II.A.2.e.
of this final rule with comment period.
Specifically, as we proposed, we divided the remaining claims into
the following five groups:
1. Single Procedure Major Claims: Claims with a single separately
payable procedure (that is, status indicator ``S,'' ``T,'' ``V,'' or
``X,'' which includes codes with status indicator ``Q3''); claims with
one unit of a status indicator ``Q1'' code (``STVX-packaged'') where
there was no code with status indicator ``S,'' ``T,'' ``V,'' or ``X''
on the same claim on the same date; or claims with one unit of a status
indicator ``Q2'' code (``T-packaged'') where there was no code with a
status indicator ``T'' on the same claim on the same date.
2. Multiple Procedure Major Claims: Claims with more than one
separately payable procedure (that is, status indicator ``S,'' ``T,''
``V,'' or ``X,'' which includes codes with status indicator ``Q3''), or
multiple units of one payable procedure. These claims include those
codes with a status indicator ``Q2'' code (``T-packaged'') where there
was no procedure with a status indicator ``T'' on the same claim on the
same date of service but where there was another separately paid
procedure on the same claim with the same date of service (that is,
another code with status indicator ``S,'' ``V,'' or ``X''). We also
include in this set claims that contained one unit of one code when the
bilateral modifier was appended to the code and the code was
conditionally or independently bilateral. In these cases, the claims
represented more than one unit of the service described by the code,
notwithstanding that only one unit was billed.
3. Single Procedure Minor Claims: Claims with a single HCPCS code
that was assigned status indicator ``F,'' ``G,'' ``H,'' ``K,'' ``L,''
``R,'' ``U,'' or ``N'' and not status indicator ``Q1'' (``STVX-
packaged'') or status indicator ``Q2'' (``T-packaged'') code.
4. Multiple Procedure Minor Claims: Claims with multiple HCPCS
codes that are assigned status indicator ``F,'' ``G,'' ``H,'' ``K,''
``L,'' ``R,'' ``U,'' or ``N''; claims that contain more than one code
with status indicator ``Q1'' (``STVX-packaged'') or more than one unit
of a code with status indicator ``Q1'' but no codes with status
indicator ``S,'' ``T,'' ``V,'' or ``X'' on the same date of service; or
claims that contain more than one code with status indicator ``Q2'' (T-
packaged), or ``Q2'' and ``Q1,'' or more than one unit of a code with
status indicator ``Q2'' but no code with status indicator ``T'' on the
same date of service.
5. Non-OPPS Claims: Claims that contain no services payable under
the OPPS (that is, all status indicators other than those listed for
major or minor status). These claims were excluded from the files used
for the OPPS. Non-OPPS claims have codes paid under other fee
schedules, for example, durable medical equipment or clinical
laboratory tests, and do not contain a code for a separately payable or
packaged OPPS service. Non-OPPS claims include claims for therapy
services paid sometimes under the OPPS but billed, in these non-OPPS
cases, with revenue codes indicating that the therapy services would be
paid under the Medicare Physician Fee Schedule (MPFS).
The claims listed in numbers 1, 2, 3, and 4 above are included in
the data file that can be purchased as described above. Claims that
contain codes to which we have assigned status indicators ``Q1''
(``STVX-packaged'') and ``Q2'' (``T-packaged'') appear in the data for
the single major file, the multiple major file, and the multiple minor
file used for ratesetting. Claims that contain codes to which we have
assigned status indicator ``Q3'' (composite APC members) appear in both
the data of the single and multiple major files used in this final rule
with comment period, depending on the specific composite calculation.
(2) Creation of ``Pseudo'' Single Procedure Claims
To develop ``pseudo'' single procedure claims for this final rule
with comment period, we examined both the multiple procedure major
claims and the multiple procedure minor claims. We first examined the
multiple major procedure claims for dates of service to determine if we
could break them into ``pseudo'' single procedure claims using the
dates of service for all lines on the claim. If we could create claims
with single major procedures by using dates of service, we created a
single procedure claim record for each separately payable procedure on
a different date of service (that is, a ``pseudo'' single procedure
claim).
We also use the bypass codes listed in Addendum N to this final
rule with comment period (which is available via the Internet on our
Web site) and discussed in section II.A.1.b. of this final rule with
comment period to remove separately payable procedures which we
determined contained limited
[[Page 68228]]
or no packaged costs or that were otherwise suitable for inclusion on
the bypass list from a multiple procedure bill. As discussed above, we
ignore the ``overlap bypass codes,'' that is, those HCPCS codes that
are both on the bypass list and are members of the multiple imaging
composite APCs, in this initial assessment for ``pseudo'' single
procedure claims. The final CY 2013 ``overlap bypass codes'' are listed
in Addendum N to this final rule with comment period (which is
available via the Internet on the CMS Web site). When one of the two
separately payable procedures on a multiple procedure claim was on the
bypass list, we split the claim into two ``pseudo'' single procedure
claim records. The single procedure claim record that contained the
bypass code did not retain packaged services. The single procedure
claim record that contained the other separately payable procedure (but
no bypass code) retained the packaged revenue code charges and the
packaged HCPCS code charges. We also removed lines that contained
multiple units of codes on the bypass list and treated them as
``pseudo'' single procedure claims by dividing the cost for the
multiple units by the number of units on the line. If one unit of a
single, separately payable procedure code remained on the claim after
removal of the multiple units of the bypass code, we created a
``pseudo'' single procedure claim from that residual claim record,
which retained the costs of packaged revenue codes and packaged HCPCS
codes. This enabled us to use claims that would otherwise be multiple
procedure claims and could not be used.
We then assessed the claims to determine if the criteria for the
multiple imaging composite APCs, discussed in section II.A.2.e.(5) of
this final rule with comment period, were met. If the criteria for the
imaging composite APCs were met, we created a ``single session'' claim
for the applicable imaging composite service and determined whether we
could use the claim in ratesetting. For HCPCS codes that are both
conditionally packaged and are members of a multiple imaging composite
APC, we first assessed whether the code would be packaged and, if so,
the code ceased to be available for further assessment as part of the
composite APC. Because the packaged code would not be a separately
payable procedure, we considered it to be unavailable for use in
setting the composite APC costs on which the CY 2013 OPPS payments are
based. Having identified ``single session'' claims for the imaging
composite APCs, we reassessed the claim to determine if, after removal
of all lines for bypass codes, including the ``overlap bypass codes,''
a single unit of a single separately payable code remained on the
claim. If so, we attributed the packaged costs on the claim to the
single unit of the single remaining separately payable code other than
the bypass code to create a ``pseudo'' single procedure claim. We also
identified line-items of overlap bypass codes as a ``pseudo'' single
procedure claim. This allowed us to use more claims data for
ratesetting purposes.
As we proposed, we also examine the multiple procedure minor claims
to determine whether we could create ``pseudo'' single procedure
claims. Specifically, where the claim contained multiple codes with
status indicator ``Q1'' (``STVX-packaged'') on the same date of service
or contained multiple units of a single code with status indicator
``Q1,'' we selected the status indicator ``Q1'' HCPCS code that had the
highest CY 2012 relative payment weight, set the units to one on that
HCPCS code to reflect our policy of paying only one unit of a code with
a status indicator of ``Q1.'' We then packaged all costs for the
following into a single cost for the ``Q1'' HCPCS code that had the
highest CY 2012 relative payment weight to create a ``pseudo'' single
procedure claim for that code: Additional units of the status indicator
``Q1'' HCPCS code with the highest CY 2012 relative payment weight;
other codes with status indicator ``Q1''; and all other packaged HCPCS
codes and packaged revenue code costs. We changed the status indicator
for the selected code from the data status indicator of ``N'' to the
status indicator of the APC to which the selected procedure was
assigned for further data processing and considered this claim as a
major procedure claim. We used this claim in the calculation of the APC
geometric mean cost for the status indicator ``Q1'' HCPCS code.
Similarly, if a multiple procedure minor claim contained multiple
codes with status indicator ``Q2'' (``T-packaged'') or multiple units
of a single code with status indicator ``Q2,'' we selected the status
indicator ``Q2'' HCPCS code that had the highest CY 2012 relative
payment weight and set the units to one on that HCPCS code to reflect
our policy of paying only one unit of a code with a status indicator of
``Q2.'' We then packaged all costs for the following into a single cost
for the ``Q2'' HCPCS code that had the highest CY 2012 relative payment
weight to create a ``pseudo'' single procedure claim for that code:
Additional units of the status indicator ``Q2'' HCPCS code with the
highest CY 2012 relative payment weight; other codes with status
indicator ``Q2''; and other packaged HCPCS codes and packaged revenue
code costs. We changed the status indicator for the selected code from
a data status indicator of ``N'' to the status indicator of the APC to
which the selected code was assigned, and we considered this claim as a
major procedure claim.
If a multiple procedure minor claim contained multiple codes with
status indicator ``Q2'' (``T-packaged'') and status indicator ``Q1''
(``STVX-packaged''), we selected the T-packaged status indicator ``Q2''
HCPCS code that had the highest relative payment weight for CY 2012 and
set the units to one on that HCPCS code to reflect our policy of paying
only one unit of a code with a status indicator of ``Q2.'' We then
packaged all costs for the following into a single cost for the
selected (``T packaged'') HCPCS code to create a ``pseudo'' single
procedure claim for that code: Additional units of the status indicator
``Q2'' HCPCS code with the highest CY 2012 relative payment weight;
other codes with status indicator ``Q2''; codes with status indicator
``Q1'' (``STVX-packaged''); and other packaged HCPCS codes and packaged
revenue code costs. We selected status indicator ``Q2'' HCPCS codes
instead of ``Q1'' HCPCS codes because ``Q2'' HCPCS codes have higher CY
2012 relative payment weights. If a status indicator ``Q1'' HCPCS code
had a higher CY 2011 relative payment weight, it became the primary
code for the simulated single bill process. We changed the status
indicator for the selected status indicator ``Q2'' (``T-packaged'')
code from a data status indicator of ``N'' to the status indicator of
the APC to which the selected code was assigned and we considered this
claim as a major procedure claim.
We then applied our process for creating ``pseudo'' single
procedure claims to the conditionally packaged codes that do not meet
the criteria for packaging, which enabled us to create single procedure
claims from them, if they met the criteria for single procedure claims.
Conditionally packaged codes are identified using status indicators
``Q1'' and ``Q2,'' and are described in section XII.A. of this final
rule with comment period.
Lastly, we excluded those claims that we were not able to convert
to single procedure claims even after applying all of the techniques
for creation of ``pseudo'' single procedure claims to multiple
procedure major claims and to
[[Page 68229]]
multiple procedure minor claims. As has been our practice in recent
years, we also excluded claims that contained codes that were viewed as
independently or conditionally bilateral and that contained the
bilateral modifier (Modifier 50 (Bilateral procedure)) because the
line-item cost for the code represented the cost of two units of the
procedure, notwithstanding that hospitals billed the code with a unit
of one.
Comment: Commenters supported the proposed process for creating
``pseudo'' single procedure claims.
Response: We appreciate the commenters' support and will continue
to look for ways to refine the process to secure more claims data for
use in calculating costs.
After consideration of the public comments we received, we are
finalizing our proposals to continue to apply the methodology described
above for the purpose of creating ``pseudo'' single procedure claims
for the CY 2013 OPPS.
c. Completion of Claim Records and Geometric Mean Cost Calculations
(1) General Process
We then packaged the costs of packaged HCPCS codes (codes with
status indicator ``N'' listed in Addendum B to this final rule with
comment period (which is available via the Internet on the CMS Web
site) and the costs of those lines for codes with status indicator
``Q1'' or ``Q2'' when they are not separately paid), and the costs of
the services reported under packaged revenue codes in Table 2 below
that appeared on the claim without a HCPCS code into the cost of the
single major procedure remaining on the claim.
As noted in the CY 2008 OPPS/ASC final rule with comment period (72
FR 66606), for the CY 2008 OPPS, we adopted an APC Panel recommendation
that CMS should review the final list of packaged revenue codes for
consistency with OPPS policy and ensure that future versions of the I/
OCE edit accordingly. As we have in the past, and as we proposed, we
are continuing to compare the final list of packaged revenue codes that
we are adopting for CY 2013 to the revenue codes that the I/OCE will
package for CY 2013 to ensure consistency.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68531), we replaced the NUBC standard abbreviations for the revenue
codes listed in Table 2 of the CY 2009 OPPS/ASC proposed rule with the
most current NUBC descriptions of the revenue code categories and
subcategories to better articulate the meanings of the revenue codes
without changing the list of revenue codes. In the CY 2010 OPPS/ASC
final rule with comment period (74 FR 60362 through 60363), we
finalized changes to the packaged revenue code list based on our
examination of the updated NUBC codes and public comment on the CY 2010
proposed list of packaged revenue codes.
For CY 2013, as we did for CY 2012, we reviewed the changes to
revenue codes that were effective during CY 2011 for purposes of
determining the charges reported with revenue codes but without HCPCS
codes that we are packaging for CY 2013. We believe that the charges
reported under the revenue codes listed in Table 2 below continue to
reflect ancillary and supportive services for which hospitals report
charges without HCPCS codes. Therefore, for CY 2013, we proposed to
continue to package the costs that we derive from the charges reported
without HCPCS code under the revenue codes displayed in Table 2 below
for purposes of calculating the geometric mean costs on which the final
CY 2013 OPPS/ASC payment rates are based.
We did not receive any public comments on our proposed list of
packaged revenue codes. Therefore, for the reasons set forth in the
proposed rule (77 FR 45079 through 45081), we are finalizing the
proposed packaged revenue codes for CY 2013, without modification,
which are identified in Table 2 below. We note that these revenue codes
include only revenue codes that were in effect in CY 2011, the year of
the claims data on which the final CY 2013 OPPS payment rates are
based.
BILLING CODE 4120-01-P
[[Page 68230]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.001
[[Page 68231]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.002
[[Page 68232]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.003
BILLING CODE 4120-01-C
In accordance with our longstanding policy, we proposed to continue
to exclude: (1) claims that had zero costs after summing all costs on
the claim; and (2) claims containing packaging flag number 3. Effective
for services furnished on or after July 1, 2004, the I/OCE assigned
packaging flag number 3 to claims on which hospitals submitted token
charges less than $1.01 for a service with status indicator ``S'' or
``T'' (a major separately payable service under the OPPS) for which the
fiscal intermediary or MAC was required to allocate the sum of charges
for services with a status indicator equaling ``S'' or ``T'' based on
the relative payment weight of the APC to which each code was assigned.
We do not believe that these charges, which were token charges as
submitted by the hospital, are valid reflections of hospital resources.
Therefore, we deleted these claims. We also deleted claims for which
the charges equaled the revenue center payment (that is, the Medicare
payment) on the assumption that, where the charge equaled the payment,
to apply a CCR to the charge would not yield a valid estimate of
relative provider cost. We proposed to continue these processes for the
CY 2013 OPPS.
For the remaining claims, we then standardized 60 percent of the
costs of the claim (which we have previously determined to be the
labor-related portion) for geographic differences in labor input costs.
We made this adjustment by determining the wage index that applied to
the hospital that furnished the service and dividing the cost for the
separately paid HCPCS code furnished by the hospital by that wage
index. The claims accounting that we provide for the proposed and final
rule contains the formula we use to standardize the total cost for the
effects of the wage index. As has been our policy since the inception
of the OPPS, we use the pre-reclassified wage indices for
standardization because we believe that they better reflect the true
costs of items and services in the area in which the hospital is
located than the post-reclassification wage indices and, therefore,
would result in the most accurate unadjusted geometric mean costs.
In accordance with our longstanding practice, we also proposed to
exclude single and ``pseudo'' single procedure claims for which the
total cost on the claim was outside 3 standard deviations from the
geometric mean of units for each HCPCS code on the bypass list
(because, as discussed above, we used claims that contain multiple
units of the bypass codes).
After removing claims for hospitals with error CCRs, claims without
HCPCS codes, claims for immunizations not covered under the OPPS, and
claims for services not paid under the OPPS, approximately 116 million
claims were left. Using these approximately 116 million claims, we
created approximately 120 million single and ``pseudo'' single
procedure claims, of which we used slightly more than 120 million
single bills (after trimming out approximately 1 million claims as
discussed in section II.A.1.a. of this final rule with comment period)
in the CY 2013 geometric mean cost development and ratesetting.
As discussed above, the OPPS has historically developed the
relative weights on which APC payments are based using APC median
costs. For the CY 2013 OPPS, we proposed to calculate the APC relative
payment weights using geometric mean costs; therefore, the following
discussion of the 2 times rule violation and the development of the
relative payment weight refers to geometric means. For more detail
about the CY 2013 OPPS/ASC policy to calculate relative payment weights
based on geometric means, we refer readers to section II.A.2.f. of this
final rule with comment period.
We proposed to use these claims to calculate the CY 2013 geometric
mean costs for each separately payable HCPCS code and each APC. The
comparison of HCPCS code-specific and APC geometric mean costs
determines the applicability of the 2 times rule. Section 1833(t)(2) of
the Act provides that, subject to certain exceptions, the items and
services within an APC group shall not be treated as comparable with
respect to the use of resources if the highest median cost (or mean
cost, if elected by the Secretary) for an item or service within the
group is more than 2 times greater than the lowest median cost (or mean
cost, if so elected) for an item or service within the same group (the
2 times rule). While we have historically applied the 2 times rule
based on median costs, as part of the CY 2013 policy to develop the
OPPS relative payment weights based on geometric mean costs, we also
are applying the 2 times rule based on geometric mean costs. For a
detailed discussion of the CY 2013 policy to develop the APC relative
payment weights based on geometric mean costs, we refer readers to
section II.A.2.f. of this final rule with comment period.
We note that, for purposes of identifying significant HCPCS for
examination in the 2 times rule, we consider codes that have more than
1,000 single major claims or codes that have both greater than 99
single major claims and contribute at least 2 percent of the single
major claims used to establish the APC geometric mean cost to be
significant. This longstanding definition of when a HCPCS code is
significant for purposes of the 2 times rule was selected because we
believe that a subset of 1,000 claims is negligible within the set of
approximately 120 million single procedure or single session claims we
use for establishing geometric mean costs. Similarly, a HCPCS code for
which there are fewer than 99 single bills and which comprises less
than 2
[[Page 68233]]
percent of the single major claims within an APC will have a negligible
impact on the APC geometric mean. We note that this method of
identifying significant HCPCS codes within an APC for purposes of the 2
times rule was used in prior years under the median-based cost
methodology. Under our CY 2013 policy to base the relative payment
weights on geometric mean costs, we believe that this same
consideration for identifying significant HCPCS codes should apply
because the principles are consistent with their use in the median-
based cost methodology. Unlisted codes are not used in establishing the
percent of claims contributing to the APC, nor are their costs used in
the calculation of the APC geometric mean. Finally, we reviewed the
geometric mean costs for the services for which we pay separately under
this final rule with comment period, and we reassigned HCPCS codes to
different APCs where it was necessary to ensure clinical and resource
homogeneity within the APCs. Section III. of this final rule with
comment period includes a discussion of many of the HCPCS code
assignment changes that resulted from examination of the geometric mean
costs and for other reasons. The APC geometric means were recalculated
after we reassigned the affected HCPCS codes. Both the HCPCS code-
specific geometric means and the APC geometric means were weighted to
account for the inclusion of multiple units of the bypass codes in the
creation of ``pseudo'' single procedure claims.
Comment: Some commenters asked that CMS provide an adjustment for
medical education costs under the OPPS. These commenters stated that
CMS indicated that it would study the costs and payment differential
among different classes of providers in the April 7, 2000 OPPS final
rule but has not done so. The commenters requested that CMS conduct its
own analysis and that, if that analysis showed a difference in their
payment to cost ratios (similar to the comparison study performed to
calibrate the cancer hospital payment adjustment) due to the unique
missions of teaching hospitals, CMS should add a teaching payment
adjustment under the OPPS.
Response: Unlike payment under the IPPS, the law does not
specifically provide for payment for direct or indirect graduate
medical education costs to be made under the OPPS. Section
1833(t)(2)(E) of the Act states that the Secretary shall establish, in
a budget neutral manner ``* * * other adjustments as determined to be
necessary to ensure equitable payments, such as adjustments for certain
classes of hospitals.'' We have not found such an adjustment to be
necessary to ensure equitable payments to teaching hospitals and,
therefore, have not developed such an adjustment. As the commenters
recognized, the cancer hospital payment adjustment discussed in section
II.F. of this final rule with comment period was established based on
section 1833(t)(18) of the Act. Similarly, those hospitals were
permanently held harmless and continued to receive TOPs under section
1833(t)(7)(d)(ii) of the Act. Furthermore, in this final rule with
comment period, we have developed OPPS relative payment weights that we
believe provide appropriate and adequate payment for the complex
medical services, such as new technology services and device-dependent
procedures, which we understand are furnished largely by teaching
hospitals. The impacts of the final CY 2013 policies, by class of
hospital, are displayed in Table 57 in section XXII. of this final rule
with comment period.
After consideration of the public comments we received, we are
finalizing our proposed CY 2013 methodology for calculating the costs
upon which the CY 2013 OPPS payment rates are based.
As we discuss in sections II.A.2.d. and II.A.2.e. and in section
VIII.B. of this final rule with comment period, in some cases, APC
geometric mean costs are calculated using variations of the process
outlined above. Specifically, section II.A.2.d. of this final rule with
comment period addresses the calculation of single APC criteria-based
geometric mean costs. Section II.A.2.e. of this final rule with comment
period discusses the calculation of composite APC criteria-based
geometric mean costs. Section VIII.B. of this final rule with comment
period addresses the methodology for calculating the geometric mean
costs for partial hospitalization services.
(2) Recommendations of the Advisory Panel on Hospital Outpatient
Payment Regarding Data Development
At the August 27-28, 2012 meeting of the Advisory Panel on Hospital
Outpatient Payment (the Panel), we provided the Data Subcommittee with
a list of all APCs fluctuating by greater than 10 percent when
comparing the CY 2013 OPPS/ASC proposed rule costs based on CY 2011
claims processed through June 30, 2012, to those based on CY 2012 OPPS/
ASC final rule data (CY 2010 claims processed through June 30, 2011).
The Data Subcommittee reviewed the fluctuations in the APC costs and
their respective weights.
At the August 27-28, 2012 Panel meeting, the Panel made a number of
recommendations related to the data process. The Panel's
recommendations and our responses follow.
Recommendation: The Panel recommends that the work of the Data
Subcommittee continue.
CMS Response: We are accepting this recommendation.
Recommendation: The Panel recommends that Traci Rabine serve as the
acting chair of the Data Subcommittee for the August 2012 HOP Panel
meeting.
CMS Response: We are accepting this recommendation.
Recommendation: The Panel recommends that CMS continue to provide a
list of APCs fluctuating by more than 10 percent in costs.
CMS Response: We are accepting this recommendation.
d. Calculation of Single Procedure APC Criteria-Based Costs
(1) Device-Dependent APCs
Device-dependent APCs are populated by HCPCS codes that usually,
but not always, require that a device be implanted or used to perform
the procedure. For a full history of how we have calculated payment
rates for device-dependent APCs in previous years and a detailed
discussion of how we developed the standard device-dependent APC
ratesetting methodology, we refer readers to the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66739 through 66742). Overviews of the
procedure-to-device edits and device-to-procedure edits used in
ratesetting for device-dependent APCs are available in the CY 2005 OPPS
final rule with comment period (69 FR 65761 through 65763) and the CY
2007 OPPS/ASC final rule with comment period (71 FR 68070 through
68071).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45081 through 45082),
we proposed for CY 2013 to use the standard methodology for calculating
costs for device-dependent APCs that was finalized in the CY 2012 OPPS/
ASC final rule with comment period (76 FR 74148 through 74151). This
methodology utilizes claims data that generally represent the full cost
of the required device and the most recent cost report data.
Specifically, we proposed to calculate the costs for device-dependent
APCs for CY 2013 using only the subset of single procedure claims from
CY 2011 claims data that pass the procedure-to-device and device-to-
[[Page 68234]]
procedure edits; do not contain token charges (less than $1.01) for
devices; do not contain the ``FB'' modifier signifying that the device
was furnished without cost to the provider, or where a full credit was
received; and do not contain the ``FC'' modifier signifying that the
hospital received partial credit for the device. The procedure-to-
device edits require that when a particular procedural HCPCS code is
billed, the claim must also contain an appropriate device code, while
the device-to-procedure edits require that a claim that contains one of
a specified set of device codes also contain an appropriate procedure
code. We stated in the proposed rule that we continue to believe the
standard methodology for calculating costs for device-dependent APCs
gives us the most appropriate costs for device-dependent APCs in which
the hospital incurs the full cost of the device. In Table 4A of the
proposed rule, we listed the APCs for which we proposed to use our
standard device-dependent APC ratesetting methodology for CY 2012.
Subsequent to the publication of the CY 2013 OPPS/ASC proposed
rule, the AMA's CPT Editorial Panel created several new CPT codes
describing services related to device-dependent APCs, to be effective
beginning January 1, 2013. Our standard process for dealing with new
CPT codes effective on January 1 for the upcoming calendar year is to
assign each code to the APC that we believe contains services that are
comparable with respect to clinical characteristics and resources
required to furnish the service. The new CPT code is given a comment
indicator of ``NI'' in Addendum B to the final rule with comment period
to identify it as a new interim APC assignment for the new year and the
APC assignment for the new codes is then open to public comment for 60
days following the publication of the final rule with comment period.
As with all new CPT codes, we encourage interested stakeholders to
review those codes identified with the ``NI'' in Addendum B and
assigned to device-dependent APCs and submit public comments on those
assignments.
Our interim assignment of some of the new CPT codes for CY 2013 to
device-dependent APCs prompted us to change the titles of two APCs to
reflect more accurately the clinical configurations of those APCs for
CY 2013. Specifically, we assigned, on an interim basis, the following
codes to device-dependent APC 0107, currently titled ``Insertion of
Cardioverter-Defibrillator'': CPT code 0319T (Insertion or replacement
of subcutaneous implantable defibrillator system with subcutaneous
electrode), 0321T (Insertion of subcutaneous implantable defibrillator
pulse generator only with existing subcutaneous electrode), and 0323T
(Removal of subcutaneous implantable defibrillator pulse generator with
replacement of subcutaneous implantable defibrillator pulse generator
only). We note that the title of APC 0108 is currently ``Insertion/
Replacement/Repair of AICD Leads, Generator and Pacing Electrode.'' In
order to streamline and simplify the titles of APCs 0107 and 0108,
which both contain procedures for the implantation of cardioverter-
defibrillator pulse generators, leads, and electrodes, we are revising
their titles to reflect the insertion of cardioverter-defibrillators
without specifying the component pieces involved. Specifically, we are
revising the title of APC 0107 to read ``Level I Implantation of
Cardioverter-Defibrillator'' and the title of APC 0108 to read ``Level
II Implantation of Cardioverter-Defibrillator.''
The creation of new CPT codes involving intracoronary stent
placement procedures for CY 2013 also requires us to create nine new
HCPCS C-codes and to delete two existing HCPCS G-codes in order to
maintain the correct implementation of existing OPPS policy for CY
2013. Specifically, since CY 2003, under the OPPS, we assign coronary
stent placement procedures to separate APCs based on the use of
nondrug-eluting or drug-eluting stents (APC 0104 (Transcatheter
Placement of Intracoronary Stents) or APC 0656 (Transcatheter Placement
of Intracoronary Drug-Eluting Stents), respectively). In order to
effectuate this policy, we created HCPCS G-codes G0290 (Transcatheter
placement of a drug eluting intracoronary stent(s), percutaneous, with
or without other therapeutic intervention, any method; single vessel)
and G0291 (Transcatheter placement of a drug eluting intracoronary
stent(s), percutaneous, with or without other therapeutic intervention,
any method; each additional vessel) for drug-eluting intracoronary
stent placement procedures that parallel existing CPT codes 92980
(Transcatheter placement of an intracoronary stent(s), percutaneous,
with or without other therapeutic intervention, any method; single
vessel) and 92981 (Transcatheter placement of an intracoronary
stent(s), percutaneous, with or without other therapeutic intervention,
any method; each additional vessel), which are used to describe
nondrug-eluting intracoronary stent placement procedures. CPT codes
92980 and 92981 are assigned to APC 0104, while HCPCS codes G0290 and
G0291 are assigned to APC 0656. We refer readers to the CY 2003 OPPS
final rule with comment period (67 FR 66732 through 66734) for more
information regarding the initial implementation of this policy.
Effective January 1, 2013, the AMA's CPT Editorial Panel is
deleting CPT codes 92980 and 92981 and replacing them with the
following new CPT codes:
CPT code 92928 (Percutaneous transcatheter placement of
intracoronary stent(s), with coronary angioplasty when performed;
single major coronary artery or branch), 92929 (Percutaneous
transcatheter placement of intracoronary stent(s), with coronary
angioplasty when performed; each additional branch of a major coronary
artery (List separately in addition to code for primary procedure));
CPT code 92933 (Percutaneous transluminal coronary
atherectomy, with intracoronary stent, with coronary angioplasty when
performed; single major coronary artery or branch);
CPT code 92934 (Percutaneous transluminal coronary
atherectomy, with intracoronary stent, with coronary angioplasty when
performed; each additional branch of a major coronary artery (List
separately in addition to code for primary procedure));
CPT code 92937 (Percutaneous transluminal
revascularization of or through coronary artery bypass graft (internal
mammary, free arterial, venous), any combination of intracoronary
stent, atherectomy and angioplasty, including distal protection when
performed; single vessel);
CPT code 92938 (Percutaneous transluminal
revascularization of or through coronary artery bypass graft (internal
mammary, free arterial, venous), any combination of intracoronary
stent, atherectomy and angioplasty, including distal protection when
performed; each additional branch subtended by the bypass graft (List
separately in addition to code for primary procedure));
CPT code 92941 (Percutaneous transluminal
revascularization of acute total/subtotal occlusion during acute
myocardial infarction, coronary artery or coronary artery bypass graft,
any combination of intracoronary stent, atherectomy and angioplasty,
including aspiration thrombectomy when performed, single vessel);
CPT code 92943 (Percutaneous transluminal
revascularization of chronic total occlusion, coronary artery, coronary
artery branch, or coronary artery bypass graft, any combination of
[[Page 68235]]
intracoronary stent, atherectomy and angioplasty; single vessel); and
CPT code 92944 (Percutaneous transluminal
revascularization of chronic total occlusion, coronary artery, coronary
artery branch, or coronary artery bypass graft, any combination of
intracoronary stent, atherectomy and angioplasty; each additional
coronary artery, coronary artery branch, or bypass graft (List
separately in addition to code for primary procedure)).
In order to maintain the existing policy of differentiating payment
for intracoronary stent placement procedures involving nondrug-eluting
and drug-eluting stents, we are deleting HCPCS codes G0290 and G0291
and replacing them with the following new HCPCS C-codes to parallel the
new CPT codes:
HCPCS code C9600 (Percutaneous transcatheter placement of
drug eluting intracoronary stent(s), with coronary angioplasty when
performed; single major coronary artery or branch);
HCPCS code C9601 (Percutaneous transcatheter placement of
drug-eluting intracoronary stent(s), with coronary angioplasty when
performed; each additional branch of a major coronary artery (List
separately in addition to code for primary procedure));
HCPCS code C9602 (Percutaneous transluminal coronary
atherectomy, with drug eluting intracoronary stent, with coronary
angioplasty when performed; single major coronary artery or branch);
HCPCS code C9603 (Percutaneous transluminal coronary
atherectomy, with drug-eluting intracoronary stent, with coronary
angioplasty when performed; each additional branch of a major coronary
artery (List separately in addition to code for primary procedure));
HCPCS code C9604 (Percutaneous transluminal
revascularization of or through coronary artery bypass graft (internal
mammary, free arterial, venous), any combination of drug-eluting
intracoronary stent, atherectomy and angioplasty, including distal
protection when performed; single vessel);
HCPCS code C9605 (Percutaneous transluminal
revascularization of or through coronary artery bypass graft (internal
mammary, free arterial, venous), any combination of drug-eluting
intracoronary stent, atherectomy and angioplasty, including distal
protection when performed; each additional branch subtended by the
bypass graft (List separately in addition to code for primary
procedure));
HCPCS code C9606 (Percutaneous transluminal
revascularization of acute total/subtotal occlusion during acute
myocardial infarction, coronary artery or coronary artery bypass graft,
any combination of drug-eluting intracoronary stent, atherectomy and
angioplasty, including aspiration thrombectomy when performed, single
vessel);
HCPCS code C9607 (Percutaneous transluminal
revascularization of chronic total occlusion, coronary artery, coronary
artery branch, or coronary artery bypass graft, any combination of
drug-eluting intracoronary stent, atherectomy and angioplasty; single
vessel); and
HCPCS code C9608 (Percutaneous transluminal
revascularization of chronic total occlusion, coronary artery, coronary
artery branch, or coronary artery bypass graft, any combination of
drug-eluting intracoronary stent, atherectomy and angioplasty; each
additional coronary artery, coronary artery branch, or bypass graft
(List separately in addition to code for primary procedure)).
The interim APC assignment for CPT codes 92928, 92933, 92929,
92934, 92937, 92938, 92941, 92943, and 92944 is APC 0104, and the
interim APC assignment for HCPCS codes C9600, C9601, C9602, C9603,
C9604, C9605, C9606, C9607, and C9608 is APC 0656 for CY 2013.
Comment: One commenter requested that CPT code 0304T (Insertion or
removal and replacement of intracardiac ischemia monitoring system
including imaging supervision and interpretation when performed and
intra-operative interrogation and programming when performed; device
only) be placed in APC 0107 (Level I Implantation of Cardioverter-
Defibrillators (ICDs)), rather than APC 0090 (Insertion/Replacement of
Pacemaker Pulse Generator), because CPT code 0304T describes the
insertion or removal and replacement of a device, which is similar to
other CPT codes assigned to APC 0107, such as CPT code 33262 (Removal
of pacing cardioverter-defibrillator pulse generator with replacement
of pacing cardioverter-defibrillator pulse generator; single lead
system). The commenter also stated that CPT code 33224 (Insertion of
pacing electrode, cardiac venous system, for left ventricular pacing,
with attachment to previously placed pacemaker or pacing cardioverter-
defibrillator pulse generator (including revision of pocket, removal,
insertion, and/or replacement of existing generator) is better aligned
with APC 0107 than with its current APC assignment of APC 0655
(Insertion/Replacement/Conversion of a Permanent Dual Chamber Pacemaker
or Pacing Electrode).
Response: We disagree with the commenter's assertion that CPT codes
0304T and 33224 should be placed in APC 0107. APC 0107 includes
procedures involving the insertion of a cardioverter-defibrillator, and
CPT codes 0304T and 33224 do not describe such procedures.
Comment: One commenter suggested that CMS consider the assignment
of different APCs for upgrades to a pacemaker or cardioverter-
defibrillator based on the number of leads inserted, which can result
in cost differences among procedures.
Response: The commenter did not provide specific CPT codes for
pacemaker or cardioverter-defibrillator insertion procedures for us to
consider. Generally speaking, however, we believe that our standard
ratesetting methodology for device-dependent APCs would appropriately
capture hospitals' varying costs based on the number of leads inserted
during these procedures because we use data from hospital claims and
cost reports that would reflect any such differences in costs.
Comment: Commenters expressed appreciation for the proposed
increase in payment for the cochlear implant procedure, described by
CPT code 69930 (Cochlear device implantation, with or without
mastoidectomy) which is assigned to APC 0259 (Level VII ENT
Procedures). However, the commenters also expressed concern that the
increase does not reflect the actual cost of the procedure and device.
The commenters indicated potential coding errors by major hospital
facilities where claims for less expensive osseointegrated auditory
device implant procedures (such as those assigned to APC 0425 (Level II
Arthroplasty or Implantation with Prosthesis)) were included in the
dataset used for calculation of cochlear implants, and requested that
CMS review the APC 0259 source data and remove the claims that were
inadvertently included as part of the original dataset to ensure the
appropriate payment.
Response: We employ procedure-to-device and device-to-procedure
edits to ensure that the appropriate procedures and devices are
correctly billed together and those same edits are again used in
modeling the OPPS payment rates for the respective device-dependent
APCs. Only claims containing the appropriate procedure and device code
pairings are used to model the estimated APC cost for device-dependent
APCs. We also note that the cochlear implant procedure and the
osseointegrated
[[Page 68236]]
auditory device implant procedures are in different APCs; therefore,
only single claims containing one of these procedures would be used to
model the estimated APC cost for their respective APCs. Further, claims
with multiple major procedures generally are not entered into the
dataset used for calculating estimated APC costs. Therefore, we do not
believe that the inclusion of claims containing both cochlear implant
procedures and osseointegrated auditory device implant procedures would
result in inaccurate procedure or APC cost estimations.
Comment: Some commenters pointed out an apparent discrepancy
between the listed proposed payment rate for APC 0425 in Addendum B to
the CY 2013 OPPS/ASC proposed rule when compared to the listed proposed
payment rate for APC 0425 in the data file entitled ``CY 2013 OPPS
Comparison Between Proposed Geometric Mean and Median-Based Payments.''
Commenters requested that CMS review its proposed payment rates and
determine which proposed payment rate reflects the correct geometric
mean cost for APC 0425 for use in CY 2013 OPPS ratesetting.
Some commenters also requested that CMS reconfigure APC 0425 to
ensure the procedures in the APC are similar from both a cost and
clinical cohesion perspective and thereby facilitate Medicare hospital
outpatient payment rates that are more in line with hospitals' actual
costs for orthopedic arthroplasty procedures. Specifically, the
commenters argued that the osseointegrated auditory device implant
procedures assigned to APC 0425, such as the procedure described by CPT
code 69714 (Implantation, osseointegrated implant, temporal bone, with
percutaneous attachment to external speech processor/cochlear
stimulator; without mastoidectomy), are not related to the orthopaedic
joint replacement procedures also assigned to APC 0425. The commenters
also stated the proposed composition of APC 0425 violated the 2 times
rule because CPT code 69717 (Replacement (including removal of existing
device), osseointegrated implant, temporal bone, with percutaneous
attachment to external speech processor/cochlear stimulator; without
mastoidectomy) has a proposed mean cost of $5,382 and CPT code 25446
(Arthroplasty with prosthetic replacement; distal radius and partial or
entire carpus (total wrist)) has a proposed mean cost of $15,020.
Response: We recognize the discrepancy between the proposed payment
rate for APC 0425 in Addendum B to the CY 2013 OPPS/ASC proposed rule
and the proposed payment rate for APC 0425 listed in the ``CY 2013 OPPS
Comparison Between Proposed Geometric Mean and Median-Based Payments''
data file. The cost statistics used in the generation of the ``CY 2013
OPPS Comparison Between Proposed Geometric Mean and Median-Based
Payments'' data file did not reflect the final configuration of the
proposed CY 2013 OPPS relative payment weights; thus, the proposed
payment rate reflected in that data file was inaccurate.
We believe that the current configuration of APC 0425 is
appropriate as all procedures within the APC share clinical and
resource similarity. Specifically, we disagree with the commenters who
asserted that the osseointegrated auditory device implant procedures
assigned to APC 0425 are not related to the orthopaedic joint
replacement procedures also assigned to APC 0425. As we have stated in
the past (73 FR 68539), all procedures assigned to APC 0425, including
the osseointegrated auditory device implant procedures, involve the
implantation of a prosthetic device into bone. We also note the
assignments of CPT codes 69717 and 25446 to APC 0425 do not violate the
2 times rule as the commenters claimed. As discussed in section
III.B.2. of the proposed rule and this final rule with comment period,
we consider only those HCPCS codes that are significant, based on the
number of claims, in making this determination. For purposes of
identifying significant HCPCS codes for examination in the 2 times
rule, we consider codes that have more than 1,000 single major claims
or codes that have both greater than 99 single major claims and
contribute at least 2 percent of the single major claims used to
establish the APC cost to be significant. CPT codes 69717 and 25446 do
not meet this criteria and their inclusion in the same APC, therefore,
does not violate the 2 times rule because they are not considered
significant.
Comment: One commenter stated that CMS should study further the
claims for any device-dependent APC for which the calculated proposed
payment reduction would be greater than 10 percent and take action to
correct issues that may artificially reduce these payments.
Response: We routinely examine all APCs with a greater than 10
percent fluctuation in costs as part of our annual rulemaking process.
Comment: Commenters supported CMS' determination that urology
procedures in APCs 0385 (Level I Prosthetic Urological Procedures),
0386 (Level II Prosthetic Urological Procedures), and 0674 (Prostate
Cryoablation) should be categorized as device-dependent APCs. The
commenters also requested the mandatory reporting of all HCPCS device
C-codes on hospital claims for services involving devices and asserted
that CMS should require complete and correct coding for packaged
services. The commenters urged CMS to continue to promote device coding
edits, while encouraging hospitals to remain vigilant in reporting the
costs of performing device related services, and educating hospitals on
the importance of accurate coding for devices, supplies, and other
technologies.
Response: We appreciate the commenters' support and will continue
to promote device coding edits, as well as encourage hospitals to
report all costs in performing device related services. As we have
stated in the past (73 FR68535 through 68536 and 74 FR 60367), we agree
that accurate reporting of device, supply, and technology charges will
help to ensure that these items are appropriately accounted for in
future years' OPPS payment rates. As we stated in the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68575), we strongly encourage
hospitals to report a charge for each packaged service they furnish,
either by billing the packaged HCPCS code and a charge for that service
if separate reporting is consistent with CPT and CMS instructions, by
increasing the charge for the separately paid associated service to
include the charge for the packaged service, or by reporting the charge
for the packaged service with an appropriate revenue code but without a
HCPCS code. Any of these means of charging for the packaged service
will result in the cost of the packaged service being incorporated into
the cost we estimate for the separately paid service. If a HCPCS code
is not reported when a packaged service is provided, we acknowledge
that it can be challenging to specifically track the utilization
patterns and resource cost of the packaged service itself. However, we
have no reason to believe that hospitals have not considered the cost
of the packaged service in reporting charges for the independent,
separately paid service.
After consideration of the public comments we received, we are
finalizing our proposed policy to use the standard methodology for
calculating costs for device-dependent APCs for CY 2013 that was
finalized in the CY 2012 OPPS/ASC final rule with comment period.
[[Page 68237]]
Table 3 below lists the APCs for which we used our standard device-
dependent APC ratesetting methodology for CY 2013. We refer readers to
Addendum A to this final rule with comment period (which is available
via the Internet on the CMS Web site) for the payment rates for these
device-dependent APCs for CY 2013.
BILLING CODE 4120-01-P
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(2) Blood and Blood Products
Since the implementation of the OPPS in August 2000, we have made
separate payments for blood and blood products through APCs rather than
packaging payment for them into payments for the procedures with which
they are administered. Hospital payments for the costs of blood and
blood products, as well as for the costs of collecting, processing, and
storing blood and blood products, are made through the OPPS payments
for specific blood product APCs.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45082 through 45083),
we proposed to continue for CY 2013 to establish payment rates for
blood and blood products using our blood-specific CCR methodology,
which utilizes actual or simulated CCRs from the most recently
available hospital cost reports to convert hospital charges for blood
and blood products to costs. This methodology has been our standard
ratesetting methodology for blood and blood products since CY 2005. It
was developed in response to data analysis indicating that there was a
significant difference in CCRs for those hospitals with and without
blood-specific cost centers, and past public comments indicating that
the former OPPS policy of defaulting to the overall hospital CCR for
hospitals not reporting a blood-specific cost center often resulted in
an underestimation of the true hospital costs for blood and blood
products. Specifically, in order to address the differences in CCRs and
to better reflect hospitals' costs, we proposed to continue to simulate
blood CCRs for each hospital that does not report a blood cost center
by calculating the ratio of the blood-specific CCRs to hospitals'
overall CCRs for those hospitals that do report costs and charges for
blood cost centers. We would then apply this mean ratio to the overall
CCRs of hospitals not reporting costs and charges for blood cost
centers on their cost reports in order to simulate blood-specific CCRs
for those hospitals. We calculated the costs upon which the proposed CY
2013 payment rates for blood and blood products were based using the
actual blood-specific CCR for hospitals that reported costs and charges
for a blood cost center and a hospital-specific simulated blood-
specific CCR for hospitals that did not report costs and charges for a
blood cost center. We noted that we used geometric mean unit costs for
each blood and blood product to calculate the proposed payment rates,
consistent with the methodology we proposed for other items and
services, discussed in section II.A.2.f. of the proposed rule and this
final rule with comment period.
We stated in the proposed rule that we continue to believe the
hospital-specific, blood-specific CCR methodology best responds to the
absence of a blood-specific CCR for a hospital than alternative
methodologies, such as defaulting to the overall hospital CCR or
applying an average blood-specific CCR across hospitals. Because this
methodology takes into account the unique charging and cost accounting
structure of each hospital, we stated in the proposed rule that we
believe that it yields more accurate estimated costs for these
products.
Comment: Some commenters expressed concern that the proposed APC
payment rates for some blood products are less than the acquisition
costs of those products, citing a published study of a national survey
of blood acquisition and overhead costs. According to the commenters,
the safety and availability of blood may be jeopardized without
adequate payment. The commenters asked that CMS formally consider and
evaluate potential alternative methodologies for setting APC payment
rates for blood products, preferably by seeking input from affected
stakeholders. The commenters also stated that the use of the geometric
mean methodology to calculate blood costs would result in lower payment
rates compared to the use of median costs to calculate the payment
rates for blood and blood products and urged CMS to use the median cost
instead.
Response: As we have stated in the past (75 FR 71838 through 71839
and 76 FR 74152), we continue to believe that using blood-specific CCRs
applied to hospital claims data results in payment that appropriately
reflect hospitals' relative costs of providing blood and blood products
as reported to us by
[[Page 68240]]
hospitals. We will consider any information presented to us from
affected stakeholders regarding alternative ratesetting methodologies.
We address the use of geometric mean costs to calculate blood payment
rates in section II.A.2.c. of this final rule with comment period.
Comment: One commenter expressed concern regarding coding and
payment for pre-storage pooled, leukocyte reduced platelets. According
to the commenter, hospitals currently bill for pre-storage pooled,
leukocyte reduced platelets using HCPCS code P9031 (Platelets,
leukocytes reduced, each unit) based on the number of platelet
concentrates (PCs) that are combined to create one unit of the blood
product. The commenter stated that because the number of PC units used
to make a therapeutic dose of pre-storage pooled, leukocyte reduced
platelets is variable, blood centers must notify hospitals of the
number of PCs in each therapeutic dose for the hospital's billing
purposes, even though it does not affect the cost of the product to the
hospital.
According to the commenter, a new technology exists that can make a
unit of pre-storage pooled, leukocyte reduced platelets out of fewer
PCs. However, the commenter expressed concern that the current coding
and payment based on the use of HCPCS code P9031 unfairly and
inappropriately disadvantages the use of this technology. The commenter
indicated that where a greater number of PCs are needed to make a unit
of pre-storage pooled, leukocyte reduced platelets, the hospital may
end up being paid at a rate that significantly exceeds the cost of the
product. However, according to the commenter, where the blood center
can make the pre-storage pooled, leukocyte reduced platelets using
fewer PCs, the hospital may end up receiving payment that is not
sufficient to cover the cost of the product.
The commenter stated that a separate code will be necessary to
differentiate pre-storage pooled, leukocyte reduced platelets from
other platelet products, and that an application for a unique HCPCS
code is currently pending. The commenter urged CMS, for OPPS purposes,
to take action to ensure appropriate payment for pre-storage pooled,
leukocyte reduced platelets, regardless of whether a new HCPCS code is
created.
Response: The outcome of the commenter's application for a unique
HCPCS code for pre-storage pooled, leukocyte reduced platelets is
beyond the scope of OPPS rulemaking. We note that it is an expected and
appropriate outcome of a prospective payment system that hospitals
would receive payments that are less than their costs in some cases and
exceed their costs in other cases, as the commenter described is
occurring in the case of pre-storage pooled, leukocyte reduced
platelets. Therefore, we do not believe that it is necessary for us to
take action to ensure appropriate payment for pre-storage pooled,
leukocyte reduced platelets at this time. However, we are interested in
hearing from other stakeholders regarding the current incentives and
disincentives that exist in the marketplace for pre-storage pooled,
leukocyte reduced platelets and invite public comment on payment for
the blood product described by HCPCS code P9031 in this final rule with
comment period.
After consideration of the public comments we received, we are
finalizing our proposed policy, without modification, to continue to
establish payment rates for blood and blood products using our blood-
specific CCR methodology, which utilizes actual or simulated CCRs from
the most recently available hospital cost reports to convert hospital
charges for blood and blood products to costs, for CY 2013. We continue
to believe that this methodology in CY 2013 will result in costs for
blood and blood products that appropriately reflect the relative
estimated costs of these products for hospitals without blood cost
centers and, therefore, for these blood products in general.
We refer readers to Addendum B to this final rule with comment
period (which is available via the Internet on the CMS Web site) for
the final CY 2013 payment rates for blood and blood products (which are
identified with status indicator ``R''). For a more detailed discussion
of the blood-specific CCR methodology, we refer readers to the CY 2005
OPPS proposed rule (69 FR 50524 through 50525). For a full history of
OPPS payment for blood and blood products, we refer readers to the CY
2008 OPPS/ASC final rule with comment period (72 FR 66807 through
66810).
(3) Brachytherapy Sources
Section 1833(t)(2)(H) of the Act, as added by section 621(b)(2)(C)
of Public Law 108-173 (MMA), mandated the creation of additional groups
of covered OPD services that classify devices of brachytherapy
consisting of a seed or seeds (or radioactive source) (``brachytherapy
sources'') separately from other services or groups of services. The
additional groups must reflect the number, isotope, and radioactive
intensity of the brachytherapy sources furnished and must include
separate groups for palladium-103 and iodine-125 sources. For the
history of OPPS payment for brachytherapy sources, we refer readers to
prior OPPS proposed and final rules. As we have stated previously (72
FR 66780, 73 FR 41502, 74 FR 60533 through 60534, 75 FR 71978, and 76
FR 74160), we believe that adopting the general OPPS prospective
payment methodology for brachytherapy sources is appropriate for a
number of reasons. The general OPPS payment methodology uses costs
based on claims data to set the relative payment weights for hospital
outpatient services. This payment methodology results in more
consistent, predictable, and equitable payment amounts per source
across hospitals by averaging the extremely high and low values, in
contrast to payment based on hospitals' charges adjusted to cost. We
believe that the OPPS prospective payment methodology, as opposed to
payment based on hospitals' charges adjusted to cost, has provided
hospitals with incentives for efficiency in the provision of
brachytherapy services to Medicare beneficiaries. Moreover, this
approach is consistent with our payment methodology for the vast
majority of items and services paid under the OPPS.
Therefore, in the CY 2013 OPPS/ASC proposed rule (77 FR 45087), we
proposed to use the costs from CY 2011 claims data for setting the
proposed CY 2013 payment rates for brachytherapy sources, as we
proposed for most other items and services that will be paid under the
CY 2013 OPPS. We based the proposed rates for brachytherapy sources
using geometric mean unit costs for each source, consistent with the
methodology proposed for other items and services, discussed in section
II.A.2.f. of the proposed rule. We proposed to continue the other
payment policies for brachytherapy sources we finalized and first
implemented in the CY 2010 OPPS/ASC final rule with comment period (74
FR 60537). We proposed to pay for the stranded and non-stranded NOS
codes, HCPCS codes C2698 and C2699, at a rate equal to the lowest
stranded or non-stranded prospective payment rate for such sources,
respectively, on a per source basis (as opposed, for example, to a per
mCi), which is based on the policy we established in the CY 2008 OPPS/
ASC final rule with comment period (72 FR 66785). We also proposed to
continue the policy we first implemented in the CY 2010 OPPS/ASC final
rule with comment period (74 FR 60537) regarding payment for new
[[Page 68241]]
brachytherapy sources for which we have no claims data, based on the
same reasons we discussed in the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66786; which was superseded for a period of time
by section 142 of Pub. L. 110-275). That policy is intended to enable
us to assign new HCPCS codes for new brachytherapy sources to their own
APCs, with prospective payment rates set based on our consideration of
external data and other relevant information regarding the expected
costs of the sources to hospitals.
Consistent with our policy regarding APC payments made on a
prospective basis, as we did for CY 2011 and CY 2012, we proposed to
subject brachytherapy sources to outlier payments under section
1833(t)(5) of the Act, and also to subject brachytherapy source payment
weights to scaling for purposes of budget neutrality. Hospitals can
receive outlier payments for brachytherapy sources if the costs of
furnishing brachytherapy sources meet the criteria for outlier payment
specified at 42 CFR 419.43(d). In addition, implementation of
prospective payment for brachytherapy sources provides opportunities
for eligible hospitals to receive additional payments in CY 2013 under
certain circumstances through the 7.1 percent rural adjustment, as
described in section II.E. of the proposed rule and this final rule
with comment period.
We referred readers to Addendum B to the proposed rule (which was
available via the Internet on the CMS Web site) for the proposed CY
2013 payment rates for brachytherapy sources, identified with status
indicator ``U.'' We invited public comment on this proposed policy and
also requested recommendations for new HCPCS codes to describe new
brachytherapy sources consisting of a radioactive isotope, including a
detailed rationale to support recommended new sources. In the proposed
rule, we provided an appropriate address for receipt of these
recommendations; the address is repeated at the end of this section. We
indicated that we will continue to add new brachytherapy source codes
and descriptors to our systems for payment on a quarterly basis.
Comment: A number of commenters opposed our proposal to base the
payment for brachytherapy sources on geometric mean costs, while other
commenters supported the proposal. Commenters also addressed other
payment issues related to brachytherapy:
First, some commenters claimed that there are longstanding problems
with OPPS claims data for brachytherapy source payment. For example,
commenters stated that high dose rate (HDR) sources can be used to
treat multiple patients because they decay over a 90-day period. The
commenters stated that, as a result, the per source cost depends on the
number of patients treated as well as the number of treatments and the
intensity of the treatments within the 90-day period, making adequate
payment for all hospitals difficult. Commenters asserted, as further
examples of problems with our claims data, that our claims data
continue to show a huge variation in unit costs on claims across
hospitals; that more than half of the brachytherapy APCs have proposed
payment rates based on 50 or fewer hospitals; and that our claims data
contain rank order anomalies between high-activity palladium-103 (HCPCS
code C2635) and low-activity palladium-103 sources (HCPCS codes 2640
and C2641), claiming that high-activity palladium-103 always costs more
than low-activity palladium-103.
Second, commenters stated that brachytherapy source payments
proposed for CY 2013 are unstable and fluctuate significantly from CY
2012 levels. They expressed concern about unpredictable changes in
payment rates for brachytherapy sources from year to year, stating that
proposed rates for some sources would change significantly, ranging
from a decrease of 14.2 percent for HCPCS code C2643 (Brachytherapy
source, non-stranded, cesium-131, per source) to an increase of 216
percent for HCPCS code C1716 (Brachytherapy source, non-stranded, gold-
198, per source).
Response: In response to the commenters' concerns regarding the
proposal to base payment for brachytherapy sources on geometric mean
cost, we refer readers to section II.A.2.f. of this final rule with
comment period, where we address the use of the geometric means
methodology for determining OPPS payments for brachytherapy sources for
CY 2013.
We disagree with the commenters who stated that the CY 2013
proposed payment rates for brachytherapy sources based on geometric
mean cost would change payment levels significantly from the CY 2012
payment rates. While the commenters are correct that the proposed CY
2013 payment rate changes range from -14.2 to 216 percent, when we
compare the CY 2013 proposed payment rates to the CY 2012 final payment
rates, we find that 10 of the 16 brachytherapy source codes will
receive increases or decreases of less than 10 percent, indicating
stability for the majority of the brachytherapy sources. Moreover, when
we compare the CY 2013 proposed payment rates to the CY 2012 final
payment rates, we find that 10 of the 16 brachytherapy source codes
will receive increased payment amounts per source, while 6 of the 16
codes will receive decreased payments per source.
With regard to the commenters who articulated concerns about
perceived longstanding problems such as variability of brachytherapy
source payment rates (which they have repeatedly opined in prior
years), we are pleased that, unlike in past years, the commenters did
not express objection to prospective payment for brachytherapy sources.
As we stated previously (72 FR 66782, 74 FR 60534, 75 FR 71979, and 76
FR 74161), we believe that our per-source payment methodology specific
to each source's radioisotope, radioactive intensity, and stranded or
non-stranded configuration, supplemented by payment based on the number
of sources used in a specific clinical case, adequately accounts for
the major expected sources of variability across treatments. As we also
explained previously (72 FR 66782, 74 FR 60535, and 75 FR 71979), a
prospective payment system such as the OPPS relies on the concept of
averaging, where the payment may be more or less than the estimated
cost of providing a service for a particular patient, but with the
exception of outlier cases, it is adequate to ensure access to
appropriate care. In the case of brachytherapy sources for which the
law requires separate payment groups, without packaging, the costs of
these individual items could be expected to show greater variation than
some other APCs under the OPPS because higher variability in costs for
some component items and services is not balanced with lower
variability in costs for other component items and services and because
relative weights are typically estimated using a smaller set of claims.
As we have stated previously (75 FR 71979 and 76 FR 74161), under
the budget neutral provision for the OPPS, it is the relativity of
costs of services, not their absolute costs, that is important, and we
believe that brachytherapy sources are appropriately paid according to
the standard OPPS payment approach. Furthermore, some sources may have
costs and payment rates based on 50 or fewer hospitals because it is
not uncommon for OPPS prospective payment rates to be based on claims
from a relatively small number of hospitals that furnished the service
in the year of claims data available for the OPPS update year. Fifty
hospitals may report hundreds of
[[Page 68242]]
brachytherapy source claims for many cases and comprise the universe of
hospitals using particular low-volume sources, for which we are
required to pay separately by statute. Further, our methodology for
estimating costs for brachytherapy sources utilizes all line-item
charges for those sources, which allows us to use all hospital reported
charge and estimated cost information to set payment rates for these
items. Therefore, no brachytherapy source claims are lost. We believe
that prospective payment rates based on claims from those hospitals
furnishing a particular source appropriately reflect the cost of that
source for hospitals.
In the case of high and low activity iodine-125 sources, our claims
data show that the hospitals' relative costs for the high activity
source as reported on hospital claims and in cost report data are
greater than the low activity sources, as we have noticed in the past.
However, this relationship is reversed for palladium-103 sources, as a
few commenters pointed out. As we have stated in the past (75 FR 71979
and 76 FR 74162), we do not have any information about the expected
cost differential between high and low activity sources of various
isotopes other than what is available in our claims and hospital cost
report data. For high activity palladium-103, only 8 hospitals reported
this service in CY 2010, compared to 139 and 203 hospitals for low-
activity palladium-103 sources described by HCPCS codes C2640 and
C2641, respectively. As we stated regarding this issue in the CYs 2010,
2011, and 2012 OPPS/ASC final rules with comment period (74 FR 60535,
75 FR 71979, and 76 FR 74162, respectively), it is clear that fewer
hospitals furnished high-activity palladium-103 sources than low-
activity palladium-103 sources, and we expect that the hospital cost
distribution for those hospitals could be different than the cost
distribution of the large number of hospitals reporting the low-
activity sources. These varied cost distributions clearly contribute to
the observed relationship in costs between the different types of
sources. However, we see no reason why our standard ratesetting
methodology for brachytherapy sources that relies on all claims from
all hospitals furnishing brachytherapy sources will not yield valid
costs for those hospitals furnishing the different brachytherapy
sources upon which CY 2013 prospective payments rates are based.
As we indicated in the CYs 2011 and 2012 OPPS/ASC final rules with
comment period (75 FR 71980 and 76 FR 74162, respectively), we agree
that high dose rate (HDR) brachytherapy sources such as HDR iridium-192
have a fixed active life and must be replaced every 90 days; as a
result, hospitals' per-treatment cost for the source would be dependent
on the number of treatments furnished per source. The source cost must
be amortized over the life of the source. Therefore, in establishing
their charges for HDR iridium-192, we expect hospitals to project the
number of treatments that would be provided over the life of the source
and establish their charges for the source accordingly, as we have
stated previously (72 FR 66783, 74 FR 60535, 75 FR 71980, and 76 FR
74162). For most of these OPPS services, our practice is to establish
prospective payment rates based on the costs from hospitals' claims
data to provide incentives for efficient and cost effective delivery of
these services.
Comment: One commenter requested that CMS establish appropriate
payment for HCPCS code A9527 (Iodine, I-125, sodium iodide solution,
therapeutic, per millicurie (mCi)), claiming that the source has not
been available for patients from June 2010 to July 2012, when it became
available for purchase by providers. The commenter stated that the
claims from two hospitals that reported HCPCS code A9527 are erroneous.
The commenter requested that CMS use external data based upon actual
hospital invoices to assign payment for HCPCS code A9527, which,
according to the commenter, cost hospitals in CY 2012 $28.00 per
millicurie (mCi), which is above the proposed payment rate of $20.86.
Response: We have been paying for I-125 brachytherapy solution
since 2003, both as HCPCS code A9527 and its predecessor code in the
OPPS, C2632 (Brachytherapy solution, iodine-125, per mCi). Our claims
data over the period of 2004 through 2011 show a consistent range of
costs of $16.83 to $29.42 per mCi, with several thousand units of
claims in most of those years. The claims data for HCPCS code A9527
reflect claims for 8 providers, rather than 2 as indicated by the
commenter. Therefore, we believe that we are obtaining adequate and
consistent data on HCPCS code A9527. We will maintain our use of claims
data for HCPCS code A9527 in our OPPS ratesetting for CY 2013.
Comment: One commenter requested that CMS add a new C-code and APC
for a high-activity cesium-131 brachytherapy source, which is designed
to generate isotropic emission of therapeutic radiation and to be used
primarily for the treatment of head and neck and eye cancer.
Response: We appreciate the commenter informing us of a new high-
activity cesium-131 source. However, our evaluation process of new
sources for addition to our set of codes is beyond the scope of this
rulemaking. As we state elsewhere in this final rule with comment
period, and in previous rules, such as the CY 2012 OPPS/ASC final rule
with comment period (76 FR 74163), we ask parties to submit
recommendations to us for new HCPCS codes to describe new brachytherapy
sources consisting of a radioactive isotope, including a detailed
rationale to support recommended new sources. We suggest to the
commenter to send its recommendation for this new brachytherapy source,
along with the detailed rationale to support the new source, to the
address provided at the end of this section. We will continue to add
new brachytherapy source codes and descriptors to our systems on a
quarterly basis.
Comment: One commenter supported CMS' proposal to continue the
policy of paying for new sources for which we have no claims data, with
prospective payment rates based on the consideration of external data
as well as other relevant information. The commenter expressed
appreciation for CMS' efforts to establish appropriate payment rates
for brachytherapy sources in a timely manner, and recommended that CMS
finalize this proposal.
Response: We appreciate the support and recognition of our efforts
to provide appropriate and timely payment. We are finalizing our
proposal to pay for new sources using external data and other relevant
information.
After consideration of the public comments we received, we are
finalizing our proposal to pay for brachytherapy sources at prospective
payment rates based on their source-specific geometric mean costs for
CY 2013. We refer readers to Addendum B to this final rule with comment
period (which is available via the Internet on the CMS Web site at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html) for the final CY 2013 payment rates
for brachytherapy sources, identified with status indicator ``U.'' We
also are finalizing our proposals to continue our policies regarding
payment for NOS codes for stranded and non-stranded sources and new
brachytherapy sources for which we have no claims data. Specifically,
we are finalizing our proposals to continue payment for stranded and
non-stranded NOS codes, HCPCS codes C2698 and C2699, at a rate equal to
the lowest stranded or non-stranded prospective
[[Page 68243]]
payment for such sources, respectively, as discussed in the CY 2008
OPPS/ASC final rule with comment period (72 FR 66786); and our proposal
to assign HCPCS codes for new brachytherapy sources to their own APCs,
with payment rates based on consideration of external data and other
relevant information, in the absence of claims data. Once claims data
are available, our standard ratemaking process will be applied to the
calculation of the cost for the new brachytherapy source.
Consistent with our policy regarding APC payments made on a
prospective basis, we are finalizing our proposal to subject the cost
of brachytherapy sources to the outlier provision of section 1833(t)(5)
of the Act, and also to subject brachytherapy source payment relative
weights to scaling for purposes of budget neutrality.
As stated in the proposed rule (77 FR 45087), we continue to invite
hospitals and other parties to submit recommendations to us for new
HCPCS codes to describe new brachytherapy sources consisting of a
radioactive isotope, including a detailed rationale to support
recommended new sources. Such recommendations should be directed to the
Division of Outpatient Care, Mail Stop C4-05-17, Centers for Medicare
and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. We
will continue to add new brachytherapy source codes and descriptors to
our systems for payment on a quarterly basis.
e. Calculation of Composite APC Criteria-Based Costs
As discussed in the CY 2008 OPPS/ASC final rule with comment period
(72 FR 66613), we believe it is important that the OPPS enhance
incentives for hospitals to provide necessary, high quality care and as
efficiently as possible. For CY 2008, we developed composite APCs to
provide a single payment for groups of services that are typically
performed together during a single clinical encounter and that result
in the provision of a complete service. Combining payment for multiple,
independent services into a single OPPS payment in this way enables
hospitals to manage their resources with maximum flexibility by
monitoring and adjusting the volume and efficiency of services
themselves. An additional advantage to the composite APC model is that
we can use data from correctly coded multiple procedure claims to
calculate payment rates for the specified combinations of services,
rather than relying upon single procedure claims which may be low in
volume and/or incorrectly coded. Under the OPPS, we currently have
composite policies for extended assessment and management services, low
dose rate (LDR) prostate brachytherapy, cardiac electrophysiologic
evaluation and ablation services, mental health services, multiple
imaging services, and cardiac resynchronization therapy services. We
refer readers to the CY 2008 OPPS/ASC final rule with comment period
for a full discussion of the development of the composite APC
methodology (72 FR 66611 through 66614 and 66650 through 66652) and the
CY 2012 OPPS/ASC final rule with comment period (76 FR 74163) for more
recent background.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45087 through 45094),
we proposed for CY 2013 to continue our composite policies for extended
assessment and management services, LDR prostate brachytherapy, cardiac
electrophysiologic evaluation and ablation services, mental health
services, multiple imaging services, and cardiac resynchronization
therapy services, as discussed in sections II.A.2.e.(1), II.A.2.e.(2),
II.A.2.e.(3), II.A.2.e.(4), II.A.2.e.(5), and II.A.2.e.(6),
respectively, of the proposed rule.
Comment: One commenter encouraged CMS to create payments that drive
hospitals to develop low cost deliveries of care instead of rewarding
them for excess deliveries of care, such as beneficiaries receiving up
to three CT scans in a single emergency department visit.
Response: We agree with the commenter that it is important to
create payment methodologies that encourage efficiency. As we have
stated in the past, we believe that composite APCs enable hospitals to
manage their resources with maximum flexibility by monitoring and
adjusting the volume and efficiency of services themselves. With
respect to CT scans in particular, as we discuss in section
II.A.2.e.(5) of this final rule with comment period, we provide a
single payment each time a hospital bills more than one CT on the same
date of service.
The final composite policies for extended assessment and management
services, LDR prostate brachytherapy, cardiac electrophysiologic
evaluation and ablation services, mental health services, multiple
imaging services, and cardiac resynchronization therapy services are
discussed in the following sections (II.A.2.e.(1), II.A.2.e.(2),
II.A.2.e.(3), II.A.2.e.(4), II.A.2.e.(5), and II.A.2.e.(6),
respectively) of this final rule with comment period.
(1) Extended Assessment and Management Composite APCs (APCs 8002 and
8003)
In the CY 2013 OPPS/ASC proposed rule (77 FR 45088), we proposed to
continue to include composite APC 8002 (Level I Extended Assessment and
Management Composite) and composite APC 8003 (Level II Extended
Assessment and Management Composite) in the OPPS for CY 2013. Beginning
in CY 2008, we created these two composite APCs to provide payment to
hospitals in certain circumstances when extended assessment and
management of a patient occur (an extended visit). In most
circumstances, observation services are supportive and ancillary to the
other services provided to a patient. In the circumstances when
observation care is provided in conjunction with a high level visit or
direct referral and is an integral part of a patient's extended
encounter of care, payment is made for the entire care encounter
through one of the two composite APCs as appropriate. We refer readers
to the CY 2012 OPPS/ASC final rule with comment period (76 FR 74163
through 74165) for a full discussion of this longstanding policy.
For CY 2013, we proposed to continue the extended assessment and
management composite APC payment methodology and criteria for APCs 8002
and 8003 that we finalized for CYs 2009 through 2012. We continue to
believe that the composite APCs 8002 and 8003 and related policies
provide the most appropriate means of paying for these services. We
also proposed to calculate the costs for APCs 8002 and 8003 using the
same methodology that we used to calculate the costs for composite APCs
8002 and 8003 for the CY 2008 OPPS (72 FR 66649). That is, we proposed
to use all single and ``pseudo'' single procedure claims from CY 2011
that met the criteria for payment of each composite APC and apply the
standard packaging and trimming rules to the claims before calculating
the CY 2013 costs. The proposed CY 2013 cost resulting from this
methodology for composite APC 8002 was approximately $446, which was
calculated from 17,072 single and ``pseudo'' single claims that met the
required criteria. The proposed CY 2013 cost for composite APC 8003 was
approximately $813, which was calculated from 255,231 single and
``pseudo'' single claims that met the required criteria.
We did not receive any public comments on this proposal. We are
finalizing our proposed policy, without modification, to calculate the
costs for APCs 8002 and 8003 using the same
[[Page 68244]]
methodology that we used to calculate the costs for composite APCs 8002
and 8003 for the CY 2008 OPPS (72 FR 66649). The final CY 2013 cost
resulting from this methodology for composite APC 8002 is approximately
$453, which was calculated from 19,028 single and ``pseudo'' single
claims that met the required criteria. The final CY 2013 cost for
composite APC 8003 is approximately $821, which was calculated from
284,861 single and ``pseudo'' single claims that met the required
criteria.
At its August 2012 meeting, the Advisory Panel on Hospital
Outpatient Payment (the Panel) recommended that CMS continue to report
clinic/emergency department visit and observation claims data and, if
CMS identifies changes in patterns of utilization or cost, that CMS
bring those issues to the Visits and Observation Subcommittee.
Additionally, the Panel recommended that CMS examine the costs and
frequency for Level I and Level II Extended Assessment and Management
Composite APCs associated with greater than 24 hours of observation, if
available, and report the findings to the Visits and Observation
Subcommittee. The Panel recommended that Scott Manaker, M.D., Ph.D., be
named the chair of the Visits and Observation Subcommittee. The Panel
recommended that the work of the Visits and Observation Subcommittee
continue. We are accepting these recommendations and will provide the
requested data to the Panel at a future meeting.
(2) Low Dose Rate (LDR) Prostate Brachytherapy Composite APC (APC 8001)
LDR prostate brachytherapy is a treatment for prostate cancer in
which hollow needles or catheters are inserted into the prostate,
followed by permanent implantation of radioactive sources into the
prostate through the needles/catheters. At least two CPT codes are used
to report the composite treatment service because there are separate
codes that describe placement of the needles/catheters and the
application of the brachytherapy sources: CPT code 55875 (Transperineal
placement of needles or catheters into prostate for interstitial
radioelement application, with or without cystoscopy) and CPT code
77778 (Interstitial radiation source application; complex), which are
generally present together on claims for the same date of service in
the same operative session. In order to base payment on claims for the
most common clinical scenario, and to further our goal of providing
payment under the OPPS for a larger bundle of component services
provided in a single hospital encounter, beginning in CY 2008, we began
providing a single payment for LDR prostate brachytherapy when the
composite service, reported as CPT codes 55875 and 77778, is furnished
in a single hospital encounter. We based the payment for composite APC
8001 (LDR Prostate Brachytherapy Composite) on the cost derived from
claims for the same date of service that contain both CPT codes 55875
and 77778 and that do not contain other separately paid codes that are
not on the bypass list. We refer readers to the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66652 through 66655) for a full history
of OPPS payment for LDR prostate brachytherapy and a detailed
description of how we developed the LDR prostate brachytherapy
composite APC.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45088 through 45089),
we proposed for CY 2013 to continue to pay for LDR prostate
brachytherapy services using the composite APC methodology proposed and
implemented for CY 2008 through CY 2012. That is, we proposed to use CY
2011 claims on which both CPT codes 55875 and 77778 were billed on the
same date of service with no other separately paid procedure codes
(other than those on the bypass list) to calculate the payment rate for
composite APC 8001. Consistent with our CY 2008 through CY 2012
practice, we proposed not to use the claims that met these criteria in
the calculation of the costs for APC 0163 (Level IV Cystourethroscopy
and Other Genitourinary Procedures) and APC 0651 (Complex Interstitial
Radiation Source Application), the APCs to which CPT codes 55875 and
77778 are assigned, respectively. We proposed to continue to calculate
the costs for APCs 0163 and 0651 using single and ``pseudo'' single
procedure claims. We stated that we believe that this composite APC
contributes to our goal of creating hospital incentives for efficiency
and cost containment, while providing hospitals with the most
flexibility to manage their resources. We also stated that we continue
to believe that data from claims reporting both services required for
LDR prostate brachytherapy provide the most accurate cost upon which to
base the composite APC payment rate.
Using a partial year of CY 2011 claims data available for the CY
2013 proposed rule, we were able to use 650 claims that contained both
CPT codes 55875 and 77778 to calculate the cost upon which the proposed
CY 2013 payment for composite APC 8001 was based. The proposed cost for
composite APC 8001 for CY 2013 was approximately $3,362.
Comment: A few commenters supported the proposed payment
methodology and policy for APC 8001. The commenters also supported the
continued use of the LDR prostate brachytherapy composite APC
methodology and the proposed increase in payment for CY 2013.
Response: We appreciate the commenters' support.
We are finalizing, without modification, our proposed policy for
composite APC 8001. Using a full year of CY 2011 claims data available
for this CY 2013 final rule with comment period, we were able to use
677 claims that contained both CPT codes 55875 and 77778 to calculate
the cost upon which the final CY 2013 payment for composite APC 8001 is
based. The final cost for composite APC 8001 for CY 2013 is
approximately $3,348.
(3) Cardiac Electrophysiologic Evaluation and Ablation Composite APC
(APC 8000)
Effective January 1, 2008, we established APC 8000 (Cardiac
Electrophysiologic Evaluation and Ablation Composite) to pay for a
composite service made up of at least one specified electrophysiologic
evaluation service and one specified electrophysiologic ablation
service. Correctly coded claims for these services often include
multiple codes for component services that are reported with different
CPT codes and that, prior to CY 2008, were always paid separately
through different APCs (specifically, APC 0085 (Level II
Electrophysiologic Evaluation), APC 0086 (Ablate Heart Dysrhythm
Focus), and APC 0087 (Cardiac Electrophysiologic Recording/Mapping)).
Calculating a composite APC for these services allowed us to utilize
many more claims than were available to establish the individual APC
costs for these services, and advanced our stated goal of promoting
hospital efficiency through larger payment bundles. In order to
calculate the cost upon which the payment rate for composite APC 8000
is based, we used multiple procedure claims that contained at least one
CPT code from Group A for evaluation services and at least one CPT code
from Group B for ablation services reported on the same date of service
on an individual claim. Table 9 in the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66656) identified the CPT codes that are assigned
to Groups A and B. For a full discussion of how we identified the Group
A and Group B procedures and established the payment rate for the
[[Page 68245]]
cardiac electrophysiologic evaluation and ablation composite APC, we
refer readers to the CY 2008 OPPS/ASC final rule with comment period
(72 FR 66655 through 66659). Where a service in Group A is furnished on
a date of service that is different from the date of service for a CPT
code in Group B for the same beneficiary, payments are made under the
appropriate single procedure APCs and the composite APC does not apply.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45089), we proposed
for CY 2013 to continue to pay for cardiac electrophysiologic
evaluation and ablation services using the composite APC methodology
proposed and implemented for CY 2008 through CY 2012. We stated that we
continue to believe that the cost for these services calculated from a
high volume of correctly coded multiple procedure claims would result
in an accurate and appropriate proposed payment for cardiac
electrophysiologic evaluation and ablation services when at least one
evaluation service is furnished during the same clinical encounter as
at least one ablation service. Consistent with our practice since CY
2008, we proposed not to use the claims that met the composite payment
criteria in the calculation of the costs for APCs 0085 and 0086, to
which the CPT codes in both Groups A and B for composite APC 8000 are
otherwise assigned. We proposed that the costs for APCs 0085 and 0086
would continue to be calculated using single procedure claims. For CY
2013, using a partial year of CY 2011 claims data available for the
proposed rule we were able to use 11,358 claims containing a
combination of Group A and Group B CPT codes to calculate a proposed
cost of approximately $11,458 for composite APC 8000.
Subsequent to the publication of the CY 2013 OPPS/ASC proposed
rule, the AMA's CPT Editorial Panel created five new CPT codes
describing cardiac electrophysiologic evaluation and ablation services,
to be effective January 1, 2013. These five new codes are:
CPT code 93653 (Comprehensive electrophysiologic
evaluation including insertion and repositioning of multiple electrode
catheters with induction or attempted induction of an arrhythmia with
right atrial pacing and recording, right ventricular pacing and
recording, His recording with intracardiac catheter ablation of
arrhythmogenic focus; with treatment of supraventricular tachycardia by
ablation of fast or slow atrioventricular pathway, accessory
atrioventricular connection, cavo-tricuspid isthmus or other single
atrial focus or source of atrial re-entry);
CPT code 93654 (Comprehensive electrophysiologic
evaluation including insertion and repositioning of multiple electrode
catheters with induction or attempted induction of an arrhythmia with
right atrial pacing and recording, right ventricular pacing and
recording, His recording with intracardiac catheter ablation of
arrhythmogenic focus; with treatment of ventricular tachycardia or
focus of ventricular ectopy including intracardiac electrophysiologic
3D mapping, when performed, and left ventricular pacing and recording,
when performed);
CPT code 93655 (Intracardiac catheter ablation of a
discrete mechanism of arrhythmia which is distinct from the primary
ablated mechanism, including repeat diagnostic maneuvers, to treat a
spontaneous or induced arrhythmia (List separately in addition to code
for primary procedure));
CPT code 93656 (Comprehensive electrophysiologic
evaluation including transseptal catheterizations, insertion and
repositioning of multiple electrode catheters with induction or
attempted induction of an arrhythmia with atrial recording and pacing,
when possible, right ventricular pacing and recording, His bundle
recording with intracardiac catheter ablation of arrhythmogenic focus,
with treatment of atrial fibrillation by ablation by pulmonary vein
isolation); and
CPT code 93657 (Additional linear or focal intracardiac
catheter ablation of the left or right atrium for treatment of atrial
fibrillation remaining after completion of pulmonary vein isolation
(List separately in addition to code for primary procedure)).
The CPT Editorial Panel also deleted two electrophysiologic
ablation codes, CPT code 93651 (Intracardiac catheter ablation of
arrhythmogenic focus; for treatment of supraventricular tachycardia by
ablation of fast or slow atrioventricular pathways, accessory
atrioventricular connections or other atrial foci, singly or in
combination) and CPT code 93652 (Intracardiac catheter ablation of
arrhythmogenic focus; for treatment of ventricular tachycardia),
effective January 1, 2013.
Our standard process for dealing with new CPT codes effective on
January 1 for the upcoming calendar year is to assign each code to the
APC that we believe contains services that are comparable with respect
to clinical characteristics and resources required to furnish the
service. The new CPT code is given a comment indicator of ``NI'' in
Addendum B to the final rule with comment period to identify it as a
new interim APC assignment for the new year and the APC assignment for
the new CPT codes is then open to public comment for 60 days following
the publication of the final rule with comment period.
New CPT codes 93653, 93654, and 93656 are primary
electrophysiologic services that encompass evaluation as well as
ablation, while new CPT codes 93655 and 93657 are add-on codes. Because
CPT codes 93653, 93654, and 93656 already encompass both evaluation and
ablation services, we are assigning them to composite APC 8000 with no
further requirement to have another electrophysiologic service from
either Group A or Group B furnished on the same date of service, and we
are assigning them interim status indicator ``Q3'' (Codes that may be
paid through a composite APC) in Addendum B to this final rule with
comment period. To facilitate implementing this policy, we are
assigning CPT codes 93653, 93654, and 93656 to a new Group C, which
will be paid at the composite APC 8000 payment rate. (We note that we
will use single and ``pseudo'' single claims for CPT codes 93653,
93654, and 93656 when they become available for calculating the costs
upon which the payment rate for APC 8000 will be based in future
ratesetting.) Because CPT codes 93655 and 93657 are dependent services
that may only be performed as ancillary services to the primary CPT
codes 93653, 93654, and 93656, we believe that packaging CPT codes
93655 and 93657 with the primary procedures is appropriate, and we are
assigning them interim status indicator ``N.'' Because the CPT
Editorial Panel deleted CPT codes 93651 and 93652, effective January 1,
2013, we are deleting them from the Group B code list, leaving only CPT
93650 (Intracardiac catheter ablation of atrioventricular node
function, atrioventricular conduction for creation of complete heart
block, with or without temporary pacemaker placement) in Group B at
this time.
As is our usual practice for new CPT codes that were not available
at the time of the proposed rule, our treatment of new CPT codes 93653,
93654, 93655, 93656, and 93657 is open to public comment for a period
of 60 days following the publication of this final rule with comment
period.
We did not receive any public comments on our proposal to continue
to pay for cardiac electrophysiologic evaluation and ablation services
using the composite APC methodology. We are finalizing our proposed
policy for CY 2013 to continue to pay for cardiac
[[Page 68246]]
electrophysiologic evaluation and ablation services using the composite
APC methodology proposed and implemented for CY 2008 through CY 2012.
We note that we are modifying our proposal for CY 2013 to reflect the
CPT coding changes as discussed above. For CY 2013, using a full year
of CY 2011 claims data available for this final rule with comment
period, we were able to use 12,235 claims containing a combination of
Group A and Group B CPT codes to calculate a final cost of
approximately $11,466 for composite APC 8000.
Table 4 below lists the groups of procedures upon which we will
base composite APC 8000 for CY 2013.
BILLING CODE 4120-01-P
[[Page 68247]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.006
[[Page 68248]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.007
(4) Mental Health Services Composite APC (APC 0034)
(a) Mental Health Services Composite Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45090), we proposed
for CY 2013 to continue our longstanding policy of limiting the
aggregate payment for specified less resource-intensive mental health
services furnished on the same date to the payment for a day of partial
hospitalization provided by a hospital, which we consider to be the
most resource-intensive of all outpatient mental health treatments for
CY 2013. We refer readers to the April 7, 2000 OPPS final rule with
comment period (65 FR 18452 to 18455) for the initial discussion of
this longstanding policy and the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74168) for more recent background.
Specifically, we proposed that when the aggregate payment for
specified mental health services provided by one hospital to a single
beneficiary on one date of service based on the payment rates
associated with the APCs for the individual services exceeds the
maximum per diem partial hospitalization payment for a hospital, those
specified mental health services would be assigned to APC 0034 (Mental
Health Services Composite). We proposed to continue to set the payment
rate for APC 0034 at the same rate as we pay for APC 0176 (Level II
Partial Hospitalization (4 or more services) for Hospital-Based PHPs),
which is the maximum partial hospitalization per diem payment for a
hospital, and that the hospital would continue to be paid one unit of
APC 0034. Under this policy, the I/OCE would continue to determine
whether to pay for these specified mental health services individually
or make a single payment at the same rate as the APC 0176 per diem rate
for partial hospitalization for all of the specified mental health
services furnished by the hospital on that single date of service.
We did not receive any public comments on this proposal. Therefore,
we are finalizing our CY 2013 proposal, without modification, to
continue our longstanding policy of limiting the aggregate payment for
specified less resource-intensive mental health services furnished on
the same date by a hospital to the payment for APC 0176, which is the
maximum partial hospitalization per diem payment for a hospital for CY
2013.
(b) Coding Changes
Subsequent to the publication of the CY 2013 OPPS/ASC proposed
rule, the AMA's CPT Editorial Panel deleted 16 psychotherapy and
psychiatric diagnostic evaluation CPT codes to which the mental health
services composite APC methodology applies, and replaced them with 12
new CPT codes, to be effective January 1, 2013. The new and deleted CPT
codes are included in Table 5 below. Our standard process for
addressing new CPT codes effective on January 1 for the upcoming
calendar year is to assign each code to the APC that we believe
contains services that are comparable with respect to clinical
characteristics and resources required to furnish the service. The new
CPT code is given a comment indicator of ``NI'' in Addendum B to the
final rule with comment period to identify it as a new interim APC
assignment for the new year and the APC assignment for the new codes is
then open to public comment for 60 days following the publication of
the final rule with comment period.
[[Page 68249]]
Because the new mental health CPT codes in Table 5 replace CPT
codes that are subject to the mental health composite APC, and because
all of the HCPCS codes in the respective APCs to which these codes are
assigned for CY 2013 are subject to the mental health composite APC,
the new separately payable mental health CPT codes also will be
assigned to composite APC 0034 with an interim status indicator of
``Q3'' (Codes that may be paid through a composite APC) in Addendum B
to this final rule with comment period. The single code APC assignment,
the composite APC assignment, and the interim status indicator
assignment for each of these new CPT codes are included in Table 5
below. As discussed above for new CPT codes that were not available at
the time of the proposed rule, our treatment of these new mental health
CPT codes is open to public comment for a period of 60 days following
the publication of this final rule with comment period. The current
single code APC assignments for all of the HCPCS codes to which the
mental health composite APC policy applies, along with their composite
APC assignment and their APC assignments when the composite methodology
does not apply, can be found in Addendum M to this final rule with
comment period (which is available via the Internet on the CMS Web
site).
BILLING CODE 4120-01-P
[[Page 68250]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.008
[[Page 68251]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.009
BILLING CODE 4120-01-C
(5) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and
8008)
Effective January 1, 2009, we provide a single payment each time a
hospital bills more than one imaging procedure within an imaging family
on the same date of service, in order to reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session (73 FR 41448 through 41450). We
utilize three imaging families based on imaging modality for purposes
of this methodology: (1) Ultrasound; (2) computed tomography (CT) and
computed tomographic angiography (CTA); and (3) magnetic resonance
imaging (MRI) and magnetic resonance angiography (MRA). The HCPCS codes
subject to the multiple imaging composite policy and their respective
families are listed in Table 8 of the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74171 through 74175).
While there are three imaging families, there are five multiple
imaging composite APCs due to the statutory requirement under section
1833(t)(2)(G) of the Act that we differentiate payment for OPPS imaging
services provided with and without contrast. While the ultrasound
procedures included in the policy do not involve contrast, both CT/CTA
and MRI/MRA scans can be provided either with or without contrast. The
five multiple imaging composite APCs established in CY 2009 are:
APC 8004 (Ultrasound Composite);
APC 8005 (CT and CTA without Contrast Composite);
APC 8006 (CT and CTA with Contrast Composite);
APC 8007 (MRI and MRA without Contrast Composite); and
APC 8008 (MRI and MRA with Contrast Composite).
We define the single imaging session for the ``with contrast''
composite APCs as having at least one or more imaging procedures from
the same family performed with contrast on the same date of service.
For example, if the hospital performs an MRI without contrast during
the same session as at least one other MRI with contrast, the hospital
will receive payment for APC 8008, the ``with contrast'' composite APC.
We make a single payment for those imaging procedures that qualify
for composite APC payment, as well as any packaged services furnished
on the same date of service. The standard (noncomposite) APC
assignments continue to apply for single imaging procedures and
multiple imaging procedures performed across families. For a full
discussion of the development of the multiple imaging composite APC
methodology, we refer readers to the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68559 through 68569).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45090), we proposed to
continue for CY 2013 to pay for all multiple imaging procedures within
an imaging family performed on the same date of service using the
multiple imaging composite APC payment methodology. We stated that we
continue to believe that this policy would reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session. The proposed CY 2013 payment rates
for the five multiple imaging composite APCs (APC 8004, APC 8005, APC
8006, APC 8007, and APC 8008) were based on costs calculated from a
year of CY 2011 claims available for the CY 2013 OPPS/ASC proposed rule
that qualified for composite payment under the current policy (that is,
those claims with more than one procedure within the same family on a
single date of service). To calculate the proposed costs, we used the
same methodology that we used to calculate the final CY 2012 costs for
these composite APCs, as described in the CY 2012 OPPS/ASC final rule
with comment period (76 FR 74169). The imaging HCPCS codes that we
removed from the bypass list for purposes of calculating the proposed
multiple imaging composite APC costs, pursuant to our established
methodology (76 FR 74169), appeared in Table 11 of the proposed rule.
We were able to identify approximately 1.0 million ``single
session'' claims out of an estimated 1.5 million potential composite
cases from our ratesetting claims data, more than half of all eligible
claims, to calculate the proposed CY 2013 costs for the multiple
imaging composite APCs.
Comment: One commenter supported the proposed payment rate for APC
8004, while acknowledging the increased proposed payment rate for the
ultrasound composite and for other standard (non-composite) ultrasound
procedures.
Response: We appreciate the commenter's support.
Comment: Several commenters supported CMS' decision not to propose
any new multiple imaging composite APCs, and requested that CMS analyze
the potential impact on utilization and access for any newly proposed
multiple imaging composite APCs, and to provide notice and seek comment
for any new proposals.
Response: We appreciate the feedback regarding the multiple imaging
composite APCs. As is our usual practice, we will analyze our claims
data and provide public notice and seek comment for any new proposals
through our annual rulemaking process.
After consideration of the public comments we received, we are
finalizing our proposed policy, without modification, to calculate
multiple imaging composite APC costs for CY 2013 pursuant to our
established methodology. For this final rule with comment period, we
were able to identify approximately 1.0 million ``single session''
claims out of an
[[Page 68252]]
estimated 1.6 million potential composite cases from our ratesetting
claims data, more than half of all eligible claims, to calculate the
final CY 2013 costs for the multiple imaging composite APCs.
Table 6 below lists the HCPCS codes that will be subject to the
multiple imaging composite policy and their respective families and
approximate composite APC costs for CY 2013. Table 7 below lists the
OPPS imaging family services that overlap with HCPCS codes on the CY
2013 bypass list. We note that we mistakenly did not include CPT code
70547 (Magnetic resonance angiography, neck; without contrast
material(s)) on this list in the proposed rule. We are adding it to
this list for the final rule with comment period because it is part of
the MRI and MRA with and without contrast imaging family and is also on
the CY 2013 bypass list.
BILLING CODE 4120-01-P
[[Page 68253]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.010
[[Page 68254]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.011
[[Page 68255]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.012
[[Page 68256]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.013
[[Page 68257]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.014
[[Page 68258]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.015
BILLING CODE 4120-01-C
(6) Cardiac Resynchronization Therapy Composite APC (APC 0108)
Cardiac resynchronization therapy (CRT) uses electronic devices to
sequentially pace both sides of the heart to improve its output. CRT
utilizing a pacing electrode implanted in combination with an
implantable cardioverter defibrillator (ICD) is known as CRT-D.
Hospitals commonly report the implantation of a CRT-D system using CPT
code 33225 (Insertion of pacing electrode, cardiac venous system, for
left ventricular pacing, at time of insertion of pacing cardioverter-
defibrillator or pacemaker pulse generator (including upgrade to dual
chamber system) (List separately in addition to code for primary
procedure)) and CPT code 33249 (Insertion or repositioning of electrode
lead(s) for single or dual chamber pacing cardioverter-defibrillator
and insertion of pulse generator). As described in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74176), over the past several
years, stakeholders have pointed out significant fluctuations in the
payment rate for CPT code 33225 and that, because the definition of CPT
code 33225 specifies that the pacing electrode is inserted at the same
time as an ICD or pacemaker, CMS would not have many valid claims upon
which to calculate an accurate cost. In response to these concerns, we
established a policy beginning in CY 2012 to recognize CPT codes 33225
and 33249 as a single, composite service when the procedures are
performed on the same day and to assign them to APC 0108 (Insertion/
Replacement/Repair of AICD Leads, Generator, and Pacing Electrodes)
when they appear together on a claim with the same date of service. We
refer readers to the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74176 through 74182) for a full description of how we developed
this policy.
As described in the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74182), hospitals continue to use the same CPT codes to report
CRT-D implantation services, and the I/OCE will identify when the
combination of CPT codes 33225 and 33249 on the same day qualify for
composite service payment. We make a single composite payment for such
cases. When not performed on the same day as the service described by
CPT code 33225, the service described by CPT code 33249 is also
assigned to APC 0108. When not performed on the same day as the service
described by CPT code 33249, the service described by CPT code 33225 is
assigned to APC 0655.
In order to ensure that hospitals correctly code for CRT services
in the future, we also finalized a policy in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74182) to implement claims processing
edits that will return to providers incorrectly coded claims on which a
pacing electrode insertion (the procedure described by CPT code 33225)
is billed without one of the following procedures to insert an ICD or
pacemaker, as specified by the AMA in the CPT codebook:
33206 (Insertion or replacement of permanent pacemaker
with transvenous electrode(s); atrial);
33207 (Insertion or replacement of permanent pacemaker
with transvenous electrode(s); ventricular);
33208 (Insertion or replacement of permanent pacemaker
with transvenous electrode(s); atrial and ventricular);
33212 (Insertion or replacement of pacemaker pulse
generator only; single chamber, atrial or ventricular);
33213 (Insertion or replacement of pacemaker pulse
generator only; dual chamber, atrial or ventricular);
33214 (Upgrade of implanted pacemaker system, conversion
of single chamber system to dual chamber system (includes removal of
previously placed pulse generator, testing of existing lead, insertion
of new lead, insertion of new pulse generator));
33216 (Insertion of a single transvenous electrode,
permanent pacemaker or cardioverter-defibrillator);
33217 (Insertion of 2 transvenous electrodes, permanent
pacemaker or cardioverter-defibrillator);
33222 (Revision or relocation of skin pocket for
pacemaker);
33233 (Removal of permanent pacemaker pulse generator);
33234 (Removal of transvenous pacemaker electrode(s);
single lead system, atrial or ventricular);
33235 (Removal of transvenous pacemaker electrode(s); dual
lead system, atrial or ventricular);
33240 (Insertion of single or dual chamber pacing
cardioverter-defibrillator pulse generator); or
33249 (Insertion or repositioning of electrode lead(s) for
single or dual chamber pacing cardioverter-defibrillator and insertion
of pulse generator).
In the CY 2013 OPPS/ASC proposed rule (77 FR45094), we proposed to
continue for CY 2013 to recognize CRT-D as a single, composite service
as described above and finalized in the CY 2012 OPPS/ASC final rule
with comment period. By continuing to recognize these procedures as a
single, composite service, we are able to use a higher volume of
correctly coded claims for CPT code 33225, which, because of its add-on
code status, is always performed in conjunction with another procedure
and, therefore, to address the inherent ratesetting challenges
associated with CPT code 33225. We also noted that this policy is
consistent with the principles of a prospective payment system,
specifically to place
[[Page 68259]]
similar services that utilize technologies with varying costs in the
same APC in order to promote efficiency and decision making based on
individual patient's clinical needs rather than financial
considerations. In calculating the costs upon which the proposed
payment rate for APC 0108 was based for CY 2013, for the proposed rule,
we included single procedure claims for the individual services
assigned to APC 0108, as well as single procedure claims that contain
the composite CRT-D service, defined as the combination of CPT codes
33225 and 33249 with the same date of service. We were able to use
9,790 single claims from the CY 2013 proposed rule claims data to
calculate a proposed cost of approximately $31,491 for APC 0108.
Because CPT codes 33225 and 33249 may be treated as a composite service
for payment purposes, we proposed to continue to assign them status
indicator ``Q3'' (Codes that may be paid through a composite APC) in
Addendum B to the proposed rule. The assignment of CPT codes 33225 and
33249 to APC 0108 when treated as a composite service was also
reflected in Addendum M to the proposed rule (which is available via
the Internet on the CMS Web site).
As we noted in the proposed rule (77 FR 45094), we revised the
claims processing edits in place for CPT code 33225 due to revised
guidance from the AMA in the CPT code book specifying the codes that
should be used in conjunction with CPT code 33225. Specifically, on
February 27, 2012, the AMA posted a correction as errata to the CY 2012
CPT code book on the AMA Web site at http://www.ama-assn.org/resources/doc/cpt/cpt-corrections.pdf. This correction removed CPT code 33222
(Revision or relocation of skin pocket for pacemaker) as a service that
should be provided in conjunction with CPT code 33225, and added CPT
codes 33228 (Removal of permanent pacemaker pulse generator with
replacement of pacemaker pulse generator; dual lead system), 33229
(Removal of permanent pacemaker pulse generator with replacement of
pacemaker pulse generator; multiple lead system), 33263 (Removal of
pacing cardioverter-defibrillator pulse generator with replacement of
pacing cardioverter-defibrillator pulse generator; dual lead system),
and 33264 (Removal of pacing cardioverter-defibrillator pulse generator
with replacement of pacing cardioverter-defibrillator pulse generator;
multiple lead system). In accordance with this revised guidance, we
deleted CPT code 33222 as a code that can satisfy the claims processing
edit for CPT code 33225, and added CPT codes 33228, 33229, 33263, and
33264 as codes that can satisfy this edit beginning in CY 2012.
Comment: One commenter requested that CMS delay the status
indicator change from ``T'' to ``Q3'' for CPT code 33225, stating that
CMS does not have sufficient cost data to allow a composite payment for
this procedure. The commenter also asked that CPT code 33225 be
assigned to APC 0655 while CMS carries out further analysis.
Response: We disagree with the commenter that we do not have
sufficient cost data to allow a composite payment for the procedure
described by CPT code 33225. For this final rule with comment period,
we were able to use 3,413 single claims containing the CRT-D composite
service, defined as the combination of CPT codes 33225 and 33249 with
the same date of service, to calculate the cost of APC 0108. We note
that we did not propose to change the status indicator for CPT code
33225 from ``T'' to ``Q3'' for CY 2013 as the commenter indicated;
rather, we proposed to continue to apply the ``Q3'' status indicator to
CPT code 33225 in accordance with the status indicator and policy for
this code finalized in the CY 2012 OPPS/ASC final rule with comment
period. We also note that, when not performed on the same day as the
service described by CPT code 33249, the service described by CPT code
33225 is assigned to APC 0655 and not paid as a composite service.
After consideration of the public comment we received, we are
finalizing our proposed policy, without modification, to continue to
recognize CRT-D as a single, composite service as described above and
finalized in the CY 2012 OPPS/ASC final rule with comment period. In
calculating the costs upon which the final payment rate for APC 0108 is
based for CY 2013, for this final rule with comment period, we included
single procedure claims for the individual services assigned to APC
0108, as well as single procedure claims that contain the composite
CRT-D service, defined as the combination of CPT codes 33225 and 33249
with the same date of service. We were able to use 11,251 single claims
from the CY 2013 final rule claims data to calculate a final cost of
approximately $31,561 for APC 0108. Because CPT codes 33225 and 33249
may be treated as a composite service for payment purposes, we are
continuing to assign them status indicator ``Q3'' (Codes that may be
paid through a composite APC) in Addendum B to this final rule with
comment period.
f. Geometric Mean-Based Relative Payment Weights
As we discussed in the CY 2013 OPPS/ASC proposed rule (77 FR 45094
through 45098), when the Medicare program was first implemented,
payment for hospital services (inpatient and outpatient) was based on
hospital-specific reasonable costs attributable to furnishing services
to Medicare beneficiaries. Although payment for most Medicare hospital
inpatient services became subject to a PPS under section 1886(d) of the
Act in 1983, Medicare hospital outpatient services continued to be paid
based on hospital-specific costs. This methodology for payment provided
little incentive for hospitals to furnish such outpatient services
efficiently and in a cost effective manner. At the same time, advances
in medical technology and changes in practice patterns were bringing
about a shift in the site of medical care from the inpatient setting to
the outpatient setting.
In the Omnibus Budget Reconciliation Act of 1986 (OBRA 1986) (Pub.
L. 99-509), the Congress paved the way for development of a PPS for
hospital outpatient services. Section 9343(g) of OBRA 1986 mandated
that fiscal intermediaries require hospitals to report claims for
services under the Healthcare Common Procedure Coding System (HCPCS).
Section 9343(c) of OBRA 1986 extended the prohibition against
unbundling of hospital services under section 1862(a)(14) of the Act to
include outpatient services as well as inpatient services. The codes
under the HCPCS enabled us to determine which specific procedures and
services were billed, while the extension of the prohibition against
unbundling ensured that all nonphysician services provided to hospital
outpatients were reported on hospital bills and captured in the
hospital outpatient data that were used to develop an outpatient PPS.
The brisk increase in hospital outpatient services further led to
an interest in creating payment incentives to promote more efficient
delivery of hospital outpatient services through a Medicare outpatient
PPS. Section 9343(f) of OBRA 1986 and section 4151(b)(2) of the Omnibus
Budget Reconciliation Act of 1990 (OBRA 1990) (Pub. L. 101-508)
required that we develop a proposal to replace the hospital outpatient
payment system with a PPS and submit a report to the Congress on the
proposed system. The statutory framework for the OPPS was established
by the Balanced Budget Act (BBA) of 1997 (Pub. L. 105-33) with section
4523 amending section 1833 of
[[Page 68260]]
the Act by adding subsection (t), which provides for a PPS for hospital
outpatient department services and the BBRA of 1999 (Pub. L. 106-113),
with section 201 further amending section 1833(t) of the Act. The
implementing regulations for these statutory authorities were codified
at 42 CFR part 419, effective for services furnished on or after August
1, 2000.
Section 1833 of the Act sets forth the methodological requirements
for developing the PPS for hospital outpatient services (the OPPS). At
the onset of the OPPS, there was significant concern over observed
increases in the volume of outpatient services and corresponding
rapidly growing beneficiary coinsurance. Accordingly, much of the focus
was on finding ways to address those issues. Section 1833(t)(2)(C) of
the Act initially provided that relative payment weights for covered
outpatient department services be established based on median costs
under section 4523(a) of the BBA of 1997. Later, section 201(f) of the
BBRA of 1999 amended section 1833(t)(2)(C) of the Act to allow the
Secretary the discretion to base the establishment of relative payment
weights on either median or mean hospital costs. Since the OPPS was
initially implemented, we have established relative payment weights
based on the median hospital costs for both statistical reasons and
timely implementation concerns. The proposed rule for the OPPS was
published prior to the passage of the BBRA of 1999, which amended the
Act to permit the use of mean costs. At that time, we noted that making
payment for hospital outpatient services based on the median cost of
each APC was a way of discouraging upcoding that occurs when individual
services that are similar have disparate median costs, as well as
associating services for which there are low claims volume into the
appropriate classifications based on clinical patterns and their
resource consumption (63 FR 47562).
As discussed in the CY 2000 OPPS final rule with comment period (65
FR 18482 through 18483), initial implementation of the payment system
for hospital outpatient services was delayed due to multiple extensions
of the proposed rule comment period, Year 2000 (Y2K) system concerns,
and other systems challenges in developing the OPPS. Even though the
BBRA of 1999 passed during that period of time, and provided the
Secretary with the discretion to establish relative payment weights
under the OPPS based on mean hospital costs, we determined that
reconstructing the database to evaluate the impact of using mean costs
would have postponed implementation of the OPPS further. There were
important challenges at the time, including being responsive to
stakeholder comments regarding the initial OPPS and addressing
implementation issues so that the payment and claims processing systems
would work correctly. To do so in a timely manner was critical;
therefore, median costs were selected as an appropriate metric on which
to base payment relativity, both based on the statistical reasons noted
above and practical implementation concerns.
In addition to the reasons discussed above, developing relative
payment weights based on median costs was a way of attenuating the
impact of cost outlier cases. In an environment where facility coding
practices were still in their infancy, median costs served to minimize
the impact of any coding errors. Using median costs to establish
service cost relativity served the same function as any measure of
central tendency (including means), ensuring that the relative payment
weights used in the OPPS would, in general, account for the variety of
costs associated with providing a service.
Since the beginning of the OPPS and throughout its development, we
have striven to find ways to improve our methods for estimating the
costs associated with providing services. The dialogue with the public
regarding these issues, the meaningful information and recommendations
that the Panel (previously the APC Panel) has provided, and the
policies we have established to better derive the costs on which OPPS
payment is calculated have contributed to improving cost estimation.
However, challenges remain in our continuing effort to better estimate
the costs associated with providing services. These challenges include
our limited ability to obtain more meaningful information from the
claims and cost report data available and ensuring that the approach
used to calculate the payments for services accurately captures the
relative costs associated with providing the services. Over the years,
we have implemented many changes to the OPPS cost modeling process to
help address these challenges.
To obtain more information from the claims data we have available,
we first began bypassing codes from the standard process to develop
``pseudo'' single claims in CY 2003 (67 FR 66746). In CY 2006, this
concept later evolved into the bypass list (and its corresponding
criteria for addition) which allows us to extract more cost information
from claims that would otherwise be unusable for modeling service cost
(70 FR 68525). In CY 2008, we examined clinical areas where packaging
of services was appropriate, which allows us to use more claims in
modeling the payments for primary procedures and encourage providers to
make cost efficient choices where possible (72 FR 66610 through 66649).
In the CY 2008 OPPS/ASC final rule with comment period (72 FR 66590),
we noted that this packaging approach increased the number of
``natural'' single bills, while simultaneously reducing the universe of
codes requiring single bills for ratesetting. Beginning in CY 2008, we
also established composite APCs for services that are typically
provided together in the same encounter, allowing us to use even more
previously unusable claims (due to containing multiple separately
payable major codes) for modeling service cost, as well as develop APCs
that reflect the combined encounter (72 FR 66650 through 66658). We
have implemented many steps to obtain more information from the claims
and cost report data available to us, and continue to examine ways in
which we can derive more meaningful information on service costs for
use in ratesetting.
In our experience in working with the OPPS, we also have
implemented many processes to ensure that the cost information we
derive from cost reports and claims data is accurate. In the beginning
of the OPPS, we implemented a cost trim of three standard deviations
outside the geometric mean cost, similar to the cost data trim in the
IPPS, because it would ensure that the most aberrant data were removed
from ratesetting (65 FR 18484). We also have implemented similar trims
to the hospital departmental CCR and claims based unit data related to
the services (71 FR 67985 through 67987).
During the CY 2008 rulemaking cycle, we contracted with Research
Triangle Institute, International (RTI) to examine possible
improvements to the OPPS cost estimation process after RTI had
investigated similar issues in the IPPS setting (72 FR 66659 through
66602). There was significant concern that charge compression, which
results from the hospital practice of attaching a higher mark-up to
charges for low cost supplies and a lower mark-up to charges for higher
cost supplies, was influencing the cost estimates on which the OPPS
relative payment weights are based. Based on RTI's recommendations in
its July 2008 report, available on the Web site at: http://www.rti.org/reports/cms/HHSM-500-2005-0029I/PDF/Refining_Cost_to_Charge_Ratios_200807_Final.pdf, in CY 2009, we finalized
[[Page 68261]]
modifications to the Medicare cost report form to create an
``Implantable Medical Devices Charged to Patients'' cost center to
address public commenters' concerns related to charge compression in
the ``Medical Supplies Charged to Patients'' cost center (73 FR 48458
through 48467). These modifications helped to address potential issues
related to hospital mark-up practices and how they are reflected in the
CCRs on the Medicare hospital cost reporting form.
In CY 2010, we incorporated a line item trim into our data process
that removed lines that were eligible for OPPS payment in the claim
year but received no payment, presumably because of a line item
rejection or denial due to claims processing edits (74 FR 60359). This
line item trim was developed with the goal of using additional lines to
model prospective payment.
In addition to these process changes that were designed to include
more accurate cost data in ratesetting, we have developed a number of
nonstandard modeling processes to support service or APC specific
changes. For example, in the device-dependent APCs, we have
incorporated edits into the cost estimation process to ensure that the
full cost of the device is incorporated into the primary procedure.
While we have already implemented numerous changes to the data
process in order to obtain accurate resource cost estimates associated
with providing a procedure, we continue to examine possible areas of
improvement. In the past, commenters have expressed concern over the
degree to which payment rates reflect the costs associated with
providing a service, believing that, in some cases, high cost items or
services that might be packaged are not accordingly reflected in the
payment weights (72 FR 66629 through 66630 and 66767). As mentioned
above, in the CY 2008 OPPS/ASC final rule with comment period, we
developed a packaging policy that identified a number of clinical areas
where services would be commonly performed in a manner that was
typically ancillary and supportive to other primary procedures.
Packaging for appropriate clinical areas provides an incentive for
efficient and cost-effective delivery of services. In that final rule
with comment period, we recognized that there were strengths and
weaknesses associated with using median costs as the metric for
developing the OPPS relative payment weights (72 FR 66615). Medians are
generally more stable than means because they are less sensitive to
extreme observations, but they also do not reflect subtle changes in
cost distributions. As a result, the use of medians rather than means
under the OPPS usually results in relative payment weight estimates
being less sensitive to packaging decisions, as well as changes in the
cost model due to factors such as the additional claims processed
between the proposed rule and the final rule.
The OPPS, like other prospective payment systems, relies on the
concept of averaging, where the payment may be more or less than the
estimated costs of providing a service or package of services for a
particular patient (73 FR 68570). Establishing the cost-based relative
payment weights based on a measure of central tendency, such as means
or medians, ensures that the payments for the package of services
should generally account for the variety of costs associated with
providing those services. Prospective payments are ultimately adjusted
for budget neutrality and updated by an OPD update factor, which
affects the calculated payments, but the accuracy of the cost-based
weights is critical in ensuring that the relative payment weights are
adjusted appropriately.
We recognize that median costs have historically served and may
continue to serve as an appropriate measure on which to establish
relative payment weights. However, as discussed above, the metric's
resistance to outlier observations is balanced by its limited ability
to be reflective of changes to the dataset used to model cost or
changes beyond the center of the dataset. While there was significant
concern in the initial years of the OPPS regarding outlier cost values
and the possible introduction of potentially aberrant values in the
cost modeling, hospital experience in coding under the system, the data
modeling improvements we have made to obtain more accurate cost
information while removing erroneous data, and other changes in our
experience with the system have all lessened the potential impact of
error values (rather than actual, accurate cost outliers). As noted
above, over the history of the OPPS, we have made multiple refinements
to the data process to better capture service costs, respond to
commenter concerns regarding the degree to which OPPS relative payment
weights accurately reflect service cost and APC payment volatility from
year to year, and better capture the variety of resource cost
associated with providing a service as provided under section
1833(t)(2)(C) of the Act. In the CY 2013 OPPS/ASC proposed rule (77 FR
45098), we proposed for CY 2013 to shift the basis for the CY 2013 APC
relative payment weights that underpin the OPPS from median costs to
geometric mean-based costs.
Geometric means better encompass the variation in costs that occur
when providing a service because, in addition to the individual cost
values that are reflected by medians, geometric means reflect the
magnitude of the cost measurements, and are thus more sensitive to
changes in the data. We believe developing the OPPS relative payment
weights based on geometric mean costs would better capture the range of
costs associated with providing services, including those cases
involving high-cost packaged services, and those cases where very
efficient hospitals have provided services at much lower costs. The use
of geometric mean-based costs also would allow us to detect changes in
the cost of services earlier, because changes in cost often diffuse
into the industry over time as opposed to impacting all hospitals
equally at the same time. Medians and geometric means both capture the
impact of uniform changes, that is, those changes that influence all
providers, but only geometric means capture cost changes that are
introduced slowly into the system on a case-by-case or hospital-by-
hospital basis.
We stated that an additional benefit of this proposed policy
relates to the 2 times rule, described in section III.B. of the
proposed rule, which is our primary tool for identifying clinically
similar services that have begun to deviate in terms of their financial
resource requirements. We stated that basing HCPCS projections on
geometric mean costs would increase the sensitivity of this tool as we
configure the APC mappings because it would allow us to detect
differences when higher costs occur in a subset of services even if the
number of services does not change. This information would allow us to
better ensure that the practice patterns associated with all the
component codes appropriately belong in the same APC.
In addition to better incorporating those cost values that surround
the median and, therefore, describing a broader range of clinical
practice patterns, we stated in the proposed rule that basing the
relative payment weights on geometric mean costs may also promote
better stability in the payment system. In the short term, geometric
mean-based relative payment weights would make the relative payment
weights more reflective of the service costs. Making this change also
may promote more payment stability in the long term by including a
broader range of observations in the relative payment
[[Page 68262]]
weights, making them less susceptible to gaps in estimated cost near
the median observation and also making changes in the relative payment
weight a better function of changes in estimated service costs.
We noted that this proposed change would bring the OPPS in line
with the IPPS, which utilizes hospital costs derived from claims and
cost report data to calculate prospective payments, and specifically,
mean costs rather than median costs to form the basis of the relative
payment weights associated with each of the payment classification
groups. We stated in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74181) our intent to explore methods to ensure our
payment systems do not provide inappropriate payment incentives to
provide services in one setting of care as opposed to another setting
of care based on financial considerations rather than clinical needs.
By adopting a means cost-based approach to calculating relative payment
weights under the OPPS, we stated that we expect to achieve greater
consistency between the methodologies used to calculate payment rates
under the IPPS and the OPPS, which would put us in a better position
from an analytic perspective to make cross-system comparisons and
examine issues of payment parity.
For the reasons described above, in the CY 2013 OPPS/ASC proposed
rule (77 FR 45098), we proposed to establish the CY 2013 OPPS relative
payment weights based on geometric mean costs. While this would involve
a change to the metric used to develop the relative payment weights,
the use of claims would not be affected. We proposed to continue to
subset claims using the data processes for modeling the standard APCs
and the criteria-based APCs described in section II.A.2. of the
proposed rule, where appropriate. The reasoning behind implementing
modeling edits or changes in the criteria-based APCs would not be
affected because the process of developing the relative payment weights
based on a measure of central tendency is the last step of the modeling
process, and occurs only once the set of claims used in ratesetting has
been established.
One important step that occurs after the development of relative
payment weights is the assignment of individual HCPCS codes (services)
to APCs. In our analysis of the impacts of a process conversion to
geometric means, we determined that the change to means would not
significantly influence the application of the 2 times rule. Very few
services would need to be shifted to new APCs because of 2 times rule
violations because the use of geometric means would resolve some
violations that would exist under the use of medians, even as it
creates other violations due to new cost projections. The net impact of
the proposed change results in seven more violations of the 2 times
rule created by the entire rebasing process than would exist if median-
based values were used.
During the development of this proposed policy, we also determined
that the cumulative effect of data shifts over the 12 years of OPPS
introduced a number of inconsistencies in the APC groupings based on
clinical and resource homogeneity. We believe that a shift to payments
derived from geometric means would improve our ability to identify
resource distinctions between previously homogenous services, and we
intend to use this information over the next year to reexamine our APC
structure and assignments to consider further ways of increasing the
stability of payments for individual services over time.
We noted that this proposed policy to establish all OPPS relative
payment weights using geometric mean costs would apply to all APCs that
would have previously been paid based on median costs. In addition, we
proposed to calculate the relative payment weights for line item based
payments such as brachytherapy sources, which were discussed in section
II.A.2.d.(6) of the proposed rule, as well as blood and blood products,
which were discussed in section II.A.2.d.(2) of the proposed rule,
based on their proposed geometric mean costs for the CY 2013 OPPS.
We indicated that the CY 2013 proposed policy to base relative
payment weights on geometric mean costs would specifically include the
CMHC and hospital-based partial hospitalization program APCs, which
were previously based on median per diem costs. Their estimated
payments would continue to be included in the budget neutral weight
scaling process, and their treatment is similar to other nonstandard
APCs discussed in section II.A. of the proposed rule. The process for
developing a set of claims that is appropriate for modeling these APCs
would continue to be the same as in recent years, with the only
proposed difference being that a geometric mean per diem cost would be
calculated rather than a median per diem cost. The proposed CY 2013
partial hospitalization payment policies were described in section
VIII. of the proposed rule.
In the proposed rule, we stated that we believe it is important to
make the transition from medians to means across all APCs in order to
capture the complete range of costs associated with all services, and
to ensure that the relative payment weights of the various APCs are
properly aligned. If some OPPS payments calculated using relative
payment weights are based on means while others are based on medians,
the ratio of the two payments will not accurately reflect the ratio of
the relative costs reported by the hospitals. This is of particular
significance in the process of establishing the budget neutral weight
scaler, discussed in section II.A.4. of the proposed rule.
We noted that the few exceptions to the applications of the
geometric mean-based relative payment weights would be the same
exceptions that exist when median-based weights are applied, including
codes paid under different payment systems or not paid under the OPPS,
items and services not paid by Medicare, items or services paid at
reasonable cost or charges reduced to cost, among others. For more
information about the various proposed payment status indicators for CY
2013, we referred readers to Addendum D1 to the proposed rule (which
was available via the Internet on the CMS Web site).
We proposed for CY 2013 that payment for nonpass-through separately
payable drugs and biologicals will continue to be developed through its
own separate process. Payments for drugs and biologicals are included
in the budget neutrality adjustments, under the requirements in section
1833(t)(9)(B) of the Act, but the budget neutral weight scaler is not
applied to their payments because they are developed through a separate
methodology, outside the relative payment weight based process. We
noted that, for CY 2013, we proposed to pay for nonpass-through
separately payable drugs and biologicals under the OPPS at ASP+6
percent, based upon the statutory default described in section
1833(t)(14)(A)(iii)(II) of the Act. Also, as is our standard
methodology, for CY 2013, we proposed to use payment rates based on the
ASP data from the fourth quarter of CY 2011 for budget neutrality
estimates, packaging determinations, and the impact analyses. For items
that did not have an ASP-based payment rate, such as some therapeutic
radiopharmaceuticals, we proposed to use their mean unit cost derived
from the CY 2011 hospital claims data to determine their per day cost.
The nonpass-through separately payable drug and biological payment
policy for CY 2013 is described in greater detail in section V.B. of
the proposed rule and this final rule with comment period.
[[Page 68263]]
Comment: Many commenters expressed cautious support for the
proposal to calculate the relative payment weights based on geometric
mean costs. The commenters believed that the inclusion of additional
cost data in developing the APC relative payment weights would
represent an improvement to the ratesetting process, while the
generally limited provider impacts and enhanced sensitivity to cost
changes in calibrating the 2 times rule would be appropriate. While the
commenters supported improvements in the accuracy of the OPPS relative
payment weights and the goals of the proposed policy, they requested
that CMS proceed with caution and transparency in this process to avoid
unintended consequences on beneficiaries and hospitals. The commenters
also suggested that CMS monitor changes in frequency and cost
distributions for services for several years to ensure that no access
to care issues develop as a result of the geometric means-based payment
policy. Several commenters requested a transitional approach to
relative payment weights based on geometric mean costs to mitigate any
potentially negative payment effects.
Response: We appreciate the commenters' support. As discussed in
the CY 2013 OPPS/ASC proposed rule, we believe that using geometric
mean costs to calculate the APC relative payment weights will make them
more reflective of the range of service costs, introduce greater
sensitivity to the 2 times rule, as well as potentially allow for
cross-system payment comparisons (77 FR 45094). We believe that the
numerous changes we have made to the data process to obtain additional
information from the available cost report and claims data and ensure
the accuracy of the cost estimation, in addition to hospital experience
with the OPPS, have prepared us to make this incremental change. We
agree that the change to base the relative payment weights on geometric
mean costs is appropriate.
We recognize the concerns that commenters have regarding a
transitional process towards geometric mean-based APC payment and the
possibility that payment fluctuations based on both the naturally
occurring variation from year to year and those variations associated
with basing the relative payment weights on geometric mean costs may
occur. However, we do not believe that an approach to geometric mean-
based OPPS relative payment weights beyond the changes we have proposed
for the CY 2013 OPPS is necessary or appropriate. Prior to proposing
this change, we evaluated the last 4 years of OPPS claims data to model
the fluctuations that would have resulted from geometric or arithmetic
means in comparison to our traditional medians. We determined that
there was no significant difference in the degree of fluctuation with
geometric means or with medians, and we also believe that the one-time
differences created by the switch are typically small; therefore, we do
not believe that a transition period is necessary. In the CY 2013 OPPS/
ASC proposed rule, we noted that we made limited changes in APC
assignments except where necessary as a result of the proposal to base
the relative payment weights on geometric mean costs and stated our
intention to further examine appropriate OPPS reconfigurations in the
future to resolve potential clinical or resource homogeneity
inconsistencies in the future to promote stability (77 FR 45097).
Geometric mean costs more fully encompass the range of costs, including
packaged costs, associated with providing a service and, therefore, may
result in payments that are more reflective of actual cost.
Transitioning into a geometric mean-based system would not be
practical, as one of the overarching goals of using geometric mean
costs is better relativity across the OPPS. Applying a phased-in
approach would potentially distort the relativity of the OPPS payment
weights. As we discuss in section II.A.2 of this final rule with
comment period, there are various reasons that contribute to cost
fluctuation from year to year. We believe that artificially introducing
stability into the payment system could potentially distort the
relativity of the payment system, especially when doing so could
potentially dampen both decreases and increases.
We agree that continued monitoring of changes in cost distributions
and the frequency of services is important in understanding the impact
of basing the APC relative payment weights on geometric mean costs.
However, we note that the frequency of services may change from year to
year based on a variety of factors, issues unrelated to OPPS payment,
and situations where APC overpayment may have potentially led to
inappropriate incentives to provide care. Despite the consideration of
the many reasons that may cause service frequency and cost structures
to change over time, we will continue to monitor these data, as well as
make that information available online through the cost statistics
files associated with each rulemaking cycle.
Comment: A number of commenters disagreed with the proposal to base
the CY 2013 OPPS/ASC relative payment weights on geometric mean costs.
Many of these commenters preferred continued use of median costs in the
ratesetting process. Several commenters believed that the geometric
mean costs were inappropriate for OPPS ratesetting for statistical
reasons, including their heightened sensitivity to lower cost inliers
and lowered sensitivity for high-cost outliers relative to arithmetic
means. Other commenters were concerned about the range between minimum
and maximum cost values for each APC, and believed them to be
implausible. A few commenters stated that while there have been
advances in coding practice over the past decade, the same problems of
upcoding and outliers will continue to exist, and that the original
selection of median costs would continue to be appropriate. One
commenter suggested that, beyond the initial years of the OPPS, there
have been no cost reporting and coding practice improvements over the
years.
Response: We noted in the CY 2013 OPPS/ASC proposed rule that
median costs have historically served and may continue to serve as an
appropriate measure on which to base the relative payment weights (77
FR 45096). However, we believe that a policy of developing the relative
payment weights based on geometric mean costs would represent an
improvement beyond our current use of the cost information available to
us.
In our discussion in the CY 2013 OPPS/ASC proposed rule relating to
basing the relative payment weights on geometric mean costs, we stated
that there are a variety of reasons that one metric might be more
appropriate than the other. However, the reasoning for selecting one
metric relative to any others must be considered in the context of the
issues at that time. In our discussion of our proposal to develop the
relative payment weights based on geometric mean costs, we described
the issues at the initial development of the OPPS and our original
reasons for selecting median costs as the preferred metric. We also
described in the proposed rule the many data process changes that we
made over the history of the OPPS, including various trimming
methodologies, processes to generate more information from the claims
and cost report data available to us, steps to address charge
compression, modeling and payment edits, modeling configurations to
make payment more reflective of the service or services provided, and
others (77 FR 45095 through 45096). In addition, we discussed our
belief that CMS and hospital experience with the OPPS as well as the
coding methodologies for
[[Page 68264]]
payment would have improved over the past decade. Finally, we discussed
various aspects of the geometric means proposal that would affect other
policy areas, such as ASC payment, application of the 2 times rule, and
other payment methodologies under the OPPS. For these reasons, we
established the CY 2013 OPPS/ASC proposal to base the relative payment
weights using geometric mean costs (77 FR 45094 through 45098).
We recognize that there are different aspects of each statistical
metric that may make any of them preferable to the others. Means-based
methodologies, whether arithmetic means or geometric means, incorporate
a broader range of estimated cost values into the relative payment
weights, whereas medians are less sensitive to that range of costs as
well as any changes in them. Depending on whether sensitivity towards
changes in service costs is viewed as a relevant objective or not may
guide whether selecting means or medians is a preferable alternative.
As described above, several commenters have suggested that the lack of
sensitivity towards cost changes is precisely why medians remain the
preferable option. However, in the CY 2013 OPPS/ASC proposed rule, we
noted comments in the past expressing concern regarding the degree to
which payment rates failed to reflect the costs associated with
providing a service (77 FR 45096). In light of those concerns, we
believe that geometric means and their ability to better reflect
packaging patterns and ranges in cost represent an improvement in our
cost estimation process.
With regards to the varying level of sensitivity towards cost
outliers that geometric means represent, as described above, there are
various benefits and drawbacks to each selected metric. Accordingly,
the relative payment weights associated with any service may rise or
fall, depending on the specific distribution of reported costs, and
where the geometric mean appears not only relative to the median but
also that of APC 606 (Level 3 Hospital Clinic Visits). While commenters
have suggested that there is a systemic risk for ``implausible''
values, we believe that many of the outlier values present in the data
represent actual cost outliers rather than errors, with different
accounting assumptions creating different populations of values. At the
low-cost and high-cost ends of the cost spectrum for each APC, there is
thus the potential for both ``spurious'' (atypical and/or incorrect)
data as well as accurate data to appear. Furthermore, while the minimum
and maximum values identify the most extreme outlier values, they do
not necessarily reflect the distribution of costs within the model; the
minimum and maximum values may not accurately represent the range of
costs describing the codes with greatest representation within an APC.
While commenters suggested that there has not been much of an
improvement we believe the possibility exists that conditions and
circumstances have stabilized to a certain degree over the past decade.
Part of the argument for medians at the inception of the OPPS was that
the coding system was still new, as was our use of claims data to
calculate prospective payments. Given the many improvements we have
made to our internal process of modeling and using data, we would
expect that coding and cost reporting practices have improved over that
time period as both CMS and hospitals have had the opportunity to
develop more experience with the system.
Comment: Some commenters believed that aligning the OPPS relative
payment weights on geometric mean costs would hamper hospitals' ability
to plan budgets for each year, given the degree to which payments might
fluctuate. The commenters also believed that geometric mean costs would
lead to greater instability of OPPS payment. Some commenters were
concerned about the negative impacts of APC payments declining due to
use of geometric mean costs, believing that those changes hindered
hospitals' ability to provide high quality health care.
Response: We do not believe that the policy of calculating relative
payment weights based on geometric mean costs will inevitably lead to
greater payment instability. There are a variety of factors that may
contribute to payment volatility from year to year, as we have
previously described in section II.A.2. of this final rule with comment
period. While there may be some interim fluctuation in the short term
as we realign the OPPS to be based on geometric mean costs, we expect
many of those issues to stabilize over time. When discussing payment
stability, the natural inclination is to view stability as a fixed
numerical value that stays the same over time. We evaluated this
numerical definition of stability and determined that it was not
significantly greater when geometric means were used. However, another
view of payment stability is through the relationship between costs and
the degree to which they are reflected in payments. We believe that a
policy of using geometric mean costs to develop the APC relative
payment weights will make them more reflective of the costs associated
with providing services. Further, using geometric mean costs helps
ensure that the relative payment weights accurately reflect the
distribution of costs associated with providing services, and mitigates
the possibility that any fluctuation occurs due to gaps in the
distribution of the model, rather than any material changes to the
service costs.
We also disagree with the commenter's belief that use of geometric
mean costs in calculating the relative payment weights will lead to
hospitals being unable to provide access to high-quality health care.
Geometric mean costs encompass a broader range of costs, and will
result in payments that more fully reflect the range of costs both on
the low and high ends, than median-based costs. We believe that this
will ultimately be an improvement in the data process as well as OPPS
payment policy. Although, as commenters have noted, there are many APC
payment rates that decline as a result of the alignment of relative
payments weights based on geometric mean costs, we note that a number
of APC payment rates also increase as a result of this policy. We
believe that, for most provider classes that furnish a mixed array of
services to meet the various needs of their patients, the financial
impacts from the changes in APC payment rates will be relatively
limited. In consideration of all of those factors, we believe that the
use of geometric mean costs will result in APC payments that are more
reflective of the range of service costs.
Comment: One commenter believed that median costs and the fact that
they do not reflect subtle changes in cost distributions was
appropriate to use to determine the OPPS payment rates, given aberrant
coding, billing, and charging practices by hospitals. The commenter
also believed that OPPS outlier payments would address issues where
high-cost services did not have those costs reflected in their APC
payments. Several commenters suggested that lack of sensitivity towards
packaging patterns when using median cost was why median costs would be
a more appropriate metric. Other commenters believed that the hospital
claims do not provide reliable data and that the Medicare cost report
data at the departmental level are not accurate because there is no
financial incentive to report accurate data. Commenters also stated
that RTI identified flawed cost data and pointed out that charges on
hospital claims do not match those on the cost reports. One commenter
requested that CMS delay the proposal to use geometric mean
[[Page 68265]]
costs in ratesetting until it can verify that the data are not flawed.
Response: We appreciate the need for accurate and reliable cost
information for use in the OPPS ratesetting process. Many of the
changes we have made to our data process over the past decade have
arisen with consideration of the need for accurate and reliable cost
information. To a certain extent, we can mitigate the issues raised by
those concerns through data process changes like trimming
methodologies, such as those for the line items as well as cost and
unit outliers, and modeling changes, such as those for composite and
device-dependent methodologies, to more accurately estimate cost.
However, more broadly, we rely on OPPS providers to submit accurate
cost and charge information to establish the relativity in the OPPS on
which APC payments are based.
We value the comments that stakeholders provide with regards to
potential data improvements as well as methods by which we can obtain
more accurate data. In situations such as the proton beam APCs for the
CY 2013 OPPS/ASC proposed rule and subsequent information about cost
report revisions and inaccurate coding, we must balance our reliance on
information from OPPS providers with the complementing goal of
obtaining accurate cost information. As we described in the CY 2013
OPPS/ASC proposed rule, we have taken steps to address issues such as
charge compression in areas such as the former ``Medical Supplies
Charged to Patients'' cost center by establishing a new standard cost
center for ``Implantable Medical Devices Charged to Patients.''
In the case of calculating relative payment weights based on
geometric mean costs, we believe that such a change, while affecting
the OPPS very broadly, would not involve much manipulation of the data.
Although several commenters have suggested that the lack of sensitivity
towards cost outliers is appropriate, we also have received comments
and HOP Panel presentations in the past regarding the degree to which
APC relative payments fail to reflect high-cost packaged services.
Calculating relative payment weights based on geometric mean cost is
one way of being responsive to those concerns regarding the degree to
which correctly reported claims with unusually high costs are
incorporated into the relative payment weights. While we agree that
OPPS outliers do help mitigate the financial risk associated with
performing certain services that require additional complexity or
resources, we also believe that developing the relative payment weights
based on geometric mean-based costs will help ensure that payments are
more reflective of the range of service cost.
In the CY 2013 OPPS/ASC proposed rule, in our proposal to base the
CY 2013 relative payments weights on geometric mean costs, we described
the many changes we have made since the inception of the OPPS to
improve upon our data process. These improvements have helped us obtain
more information from the claims and cost report data we have available
to us, in addition to ensuring the accuracy of the resource cost
estimates we use to model the APC relative payment weights. While we
continue to look for ways in which we can improve the OPPS and our
modeling of the estimated costs used to develop the relative payment
weights, we do not believe that the cost information and methods
through which we establish the relative payment weights are inherently
flawed. Aligning the relative payment weights based on geometric mean
costs may be a significant change in how the relative payment weights
are calculated; however, the change can be viewed as incremental based
on the other data improvements throughout the history of the OPPS, as
described earlier in this section.
We believe that incentives exist for accurate cost reporting beyond
direct financial incentives. We believe that external perceptions of
incorrect reporting are based primarily on the failure to consider
limitations of the data collection methodology when making assumptions
and conclusions. The Medicare cost report form allows hospitals to
report in a manner that is consistent with their own financial
accounting systems and, therefore, should be accurate for each
individual hospital.
The regulations at 42 CFR 413.24(f)(4)(iv) specify the
certification statement on the first page of the Medicare cost report
(Hospital and Hospital Heath Care Complex Cost Report, Form CMS-2552-
10) that must be signed by the hospital's administrator or chief
financial officer certifying that the data contained in the cost report
are true and accurate. Also included on the certification page is a
``penalty statement'' which conveys to the hospital official signing
the cost report that misrepresentation or falsification of any
information contained in the cost report is punishable by criminal,
civil, and administrative action, fine, and/or imprisonment under
Federal law. Further, the ``penalty statement'' also states that if
services identified in the cost report were provided or procured
through the payment directly or indirectly of a kickback or were
otherwise illegal, then criminal, civil, and administrative action,
fine, and/or imprisonment may result. We believe that the possibility
of mandatory cost report adjustments by fiscal intermediaries or MACs
where erroneous amounts are found to exist and the possibility of
Federal prosecution where potentially false claims and/or fraudulent
conduct are found to exist act as reasonable incentives to complete the
cost report accurately. Further, the cost report data and their use in
the OPPS cost estimation and payment rate development process, combined
with potential penalties for inaccurate reporting, provide financial
incentive for reporting costs accurately.
We recognize that hospitals are complex entities, each having their
own accounting systems and reporting methodology. As such, the cost and
charge data that they provide through the Medicare cost report forms
are structured in a way that reflects their own internal accounting
systems. Although we would obtain the most accurate information by
using a highly structured reporting format across hospitals, in using
these data for OPPS ratesetting, we must balance between our use of
these data for the cost estimation process and the burden associated
with forcing hospitals to convert to a government-mandated standardized
financial management system. The current mechanism allows us to collect
information that is accurate in the aggregate and that further, at a
granular level, reflects the relative allocation of costs to
departments and services by the industry as a whole without creating
additional burden.
We note that while the RTI investigation into charge compression
and the calculation of the relative payment weights yielded areas where
the cost estimation process could be improved, there was no suggestion
that the process or data itself were fundamentally flawed. We also note
that we have tried to be responsive to the concerns raised in the RTI
report regarding charge compression and the accuracy of the relative
payment weights, for example, through the creation of the new
``Implantable Medical Devices Charged to Patients'' standard cost
center or through the packaged cost redistribution to account for
pharmacy overhead in the past several years. Regarding the concern
about the matching process between the data used to calculate the CCRs
on the Medicare cost report and the claims-
[[Page 68266]]
based charges, we note that we use the most updated accurate
information made available to us and match them to the degree possible
to accurately calculate estimated costs. In the revenue code-to-cost
center modeling crosswalk that we use to estimate cost, the hierarchy
of cost center CCRs is based on our best assumption of where those
revenue code charges would be placed even though it may not necessarily
reflect every hospitals' individual cost report structure.
As discussed earlier in this section, we have made many
improvements to the OPPS data process over the course of the past
decade. Many of those changes were intended to either derive more
information from the claims and cost report data we have available to
us, while others were intended to estimate cost in a way that more
accurately represented the provision of the service and associated
resources. We believe that basing the relative payment weights on
geometric mean costs will improve the degree to which our APC payments
reflect the range of resource costs associated with providing services,
and represents an incremental data improvement. Therefore, we do not
believe it is appropriate to postpone the use of geometric mean costs
in establishing the CY 2013 OPPS/ASC relative payment weights.
Comment: Several commenters requested clarification regarding why
CMS selected geometric mean costs as the metric for our proposed policy
for calculating the CY 2013 OPPS/ASC relative payment weights rather
than arithmetic mean costs. Other commenters noted that using
arithmetic means would bring the OPPS even further in line with the
IPPS ratesetting methodology.
Response: While developing the proposal to establish the CY 2013
OPPS/ASC relative payment weights using geometric mean costs, we also
reviewed the volatility associated and impact of an OPPS based on
arithmetic mean costs. We also considered many of the same issues that
commenters described with respect to the use of arithmetic means,
including whether their ability to more sensitively consider the
variety of cost patterns, provide a better reflection of total costs,
and to synchronize the OPPS system with the IPPS methodology, would be
a preferable option among the three metrics.
We noted that because only natural and ``pseudo'' single major
claims would be used to model the relativity of the OPPS, arithmetic
means would not truly reflect total cost in the system. Although
arithmetic mean costs would be more sensitive towards outlier values
than both geometric mean costs and median costs, there would also be
greater volatility associated with the use of them due to their
sensitivity towards outlier values. Similarly, the short-term
transition from medians to arithmetic means would also include a
greater range of both positive and negative provider payment impacts
and would result in the need for more reconfiguration of the APCs to
resolve 2 times rule violations than geometric mean costs. While we
have discussed our intention to perform a thorough review of the OPPS
in the future that may involve more significant reconfiguration, that
review would be performed with the goal of developing more accurate and
stable payment rates, to the extent that they reflect the range of
service costs. Although we stated the possibility of using these
geometric mean based payments for exploring cross-system payment
comparisons, we recognize that there may be aspects of each payment
system data methodology that may be unique. While using arithmetic mean
costs would potentially capture the full range of costs better than
both geometric means and medians, that benefit has limited value in a
relative system such as the OPPS, where all total costs are reduced to
relative rates. Conversely, it also would potentially allow an
inappropriate impact due to aberrant values because there would be no
mitigation of the influence of outlier costs, which could be accurate
or aberrant values. Therefore, we viewed the use of geometric mean
costs as a balanced approach between both the strengths and weaknesses
of using medians and arithmetic means.
Comment: Several commenters expressed concern with regard to the
decline in APC payment to CMHCs due to use of the geometric mean cost
for calculating the OPPS relative payment weights, and recommended that
CMS continue to monitor the impact of its payment policies on CMHCs.
Response: Over the past several years, we have made changes to the
calculation of PHP relative payment weights to more accurately align
their PHP APC payments to their specific costs. These changes to PHP
relative payment weights have included establishing a separate cost
estimation process based on provider type as well as a two-tiered APC
payment system under which we pay one amount for days with 3 services
and a higher amount for days with 4 or more services for both CMHC and
hospital-based PHPs. As discussed in the CY 2013 OPPS/ASC proposed
rule, we believe that the use of geometric mean costs rather than
median costs in the ratesetting process is one such improvement because
it allows the payment metric to consider a broader range of service
costs (77 FR 45097). We will continue to monitor the impact of our
payment policies on OPPS providers, including CMHCs.
Comment: One commenter was concerned with the minimum and maximum
values associated with APCs 0690 (Level I Electronic Analysis of
Devices) and 0105 (Repair/Revision/Removal of Pacemakers, AICDs, or
Vascular Devices). In the case of APC 0690, the commenter suggested
that the APC payment rate be set to the median cost and not allowed to
drop below the payment that CMS would have calculated using medians.
For CPT 0307T (Removal of intracardiac ischemia monitoring device), the
commenter also believed that its placement in APC 0105 was appropriate.
However, the commenter requested that CMS perform an analysis to
determine whether some of the procedures might be more appropriately
placed in a different APC.
Response: In the case of both of these APCs, the presence of high-
cost, low-volume services in the claims used to model each APC creates
outliers that foster the perception that the services spread more
evenly across the range between the minimum and maximum values than
actually is the case. Those minimum and maximum values represent
individual points at the most extreme ends of the model, and include
service cost estimations that do not contribute significantly enough to
the APC weight to be considered in the application of the 2 times rule.
In that sense, those values can be misleading because the minimum and
maximum should be considered as the most extreme outlier cases; we
evaluate the range through the application of the 2 times rule, which
only considers services that have sufficient volume to demonstrate
stability and reliability and which significantly contribute to the
relative payment weight of the APC. Both medians and means are measures
of central tendency and have strengths and weaknesses when considering
the degree to which they accurately represent the dataset. Similarly,
the minimum and maximum values are informative in identifying the most
extreme outliers of a dataset but do not necessarily reflect the bulk
of the distribution.
For CPT codes 0305T and 0306T which are assigned to APC 0690, we
note that the geometric mean cost ($34.78) was slightly higher than the
[[Page 68267]]
median cost ($33.71) for the APC in the data used for the CY 2013 OPPS/
ASC proposed rule. In addition, after calculation of budget neutrality
and other adjustments, the national unadjusted payment rate for a
geometric mean cost-based APC payment was proposed to be higher than a
median cost-based one for CY 2013. Finally, for prospective APC payment
rates which are calculated through the standard process, we would not
pay using the cost as a rate but we would use the estimated costs to
establish the relative payment weights on which OPPS payments are
based. Therefore, we are not setting the payment rate for APC 0690 at
the median cost.
We appreciate the commenters' support regarding the placement of
CPT code 0307T in APC 0105. We do not agree that having a wide
distribution of costs in an APC necessarily implies that a problem in
the construction of the APC exists, particularly in cases where we
believe the clinical placement and resource use is appropriate. As
described above, the minimum and maximum values identified within each
CPT or APC are the most extreme outliers, and may not necessarily
reflect where the majority of the cost estimates are within each code.
For application of the 2 times rule discussed in section III.B. of this
final rule with comment period, we only consider codes that are
``significant'' in their contribution towards the cost estimates in the
APC as being useful in the identification of how similar the services
within an APC are to each other, from a cost perspective. However, this
does not eliminate the need to consider clinical factors when
constructing the APC assignments. We do not believe that differences in
the distribution of costs for a service automatically creates the need
for further study, especially because the purpose of geometric mean
costs is to more fully include those cost observations. Similarly, the
APC configurations are intended to group together services with
clinical and resource homogeneity. However, in the CY 2013 OPPS/ASC
proposed rule, we stated our intention of using the information we have
available to us to reexamine the APC structure and assignments to
consider further ways of increasing the stability of payments over
time, and will consider these issues as we do so in the future.
Comment: Commenters expressed concern with regard to the impact of
the use of geometric mean-based costs for other specific APCs as well
as certain clinical areas. APCs that commenters requested specific
detail about included APCs 0690 (Level I Electronic Analysis of
Devices); 0105 (Repair/Revision/Removal of Pacemakers, AICDs, or
Vascular Devices); 0331 (Combined Abdomen and Pelvis CT without
Contrast); 0334 (Combined Abdomen and Pelvis CT with Contrast); 0383
(Cardiac Computed Tomographic Imaging); 0336 (Magnetic Resonance
Imaging and Magnetic Resonance Angiography without Contrast); 0337
(Magnetic Resonance Imaging and Magnetic Resonance Angiography without
Contrast followed by Contrast); 0308 (Positron Emission Tomography
(PET) imaging); 0402 (Level II Nervous System Imaging); 0408 (Level III
Tumor/Infection Imaging); 0169 (Lithotripsy); 0385 (Level I Prosthetic
Urological Procedures); 0386 (Level II Prosthetic Urological
Procedures); and 0674 (Prostate Cryoablation). Other clinical areas
that commenters expressed concern about included otolaryngological and
orthopaedic procedures. One commenter requested that CMS ensure that
there was no disproportionate impact to any given medical specialty.
Response: In the case of these APCs, generally the issue is that
the geometric mean costs reflect lower cost values than otherwise
indicated by the median value. We have identified numerous other data
issues or policies beyond the use of geometric mean costs that may
attribute to potential declines in the relative payment weight.
For APCs 0331 and 0334, this is the first year where actual data
are available for ratesetting based on the new CY 2011 computed
tomography of abdomen/pelvis codes: CPT codes 74176 (Computed
tomography, abdomen and pelvis; without contrast material); 74177
(Computed tomography, abdomen and pelvis; with contrast material(s));
and 74178 (Computed tomography, abdomen and pelvis, without contrast
material in one or both body regions, followed by contrast material(s)
and further sections in one or both body regions). For more discussion
on the Computed Tomography of Abdomen/Pelvis APCs, we refer readers to
section II.A.7.c. of this final rule with comment period.
Another influencing factor may be the use of the new standard cost
center for ``Implantable Devices Charged to Patient''. For device-
dependent APCs 0385, 0386, and 0674, there may be effects based on use
of the new standard cost center CCR being mapped to revenues codes
where appropriate. For a discussion of the cost report CCRs used to
estimate service cost, we refer readers to section II.A.1.c. of this
final rule with comment period.
For APC 0169, the estimated costs of the APC may have changed based
on corrections to the revenue code-to-cost center crosswalk described
in the second correction notice to the CY 2012 OPPS/ASC final rule with
comment period (77 FR 24409). Further, because CPT code 50590
(Lithotripsy, extracorporeal shock wave) is the only code used to model
the APC, any variation with the estimated costs for the CPT code will
directly affect the APC relative payment weight.
For all the APCs referenced by commenters, the relative payment
weights based on using geometric mean costs now include a greater range
of resource costs associated with furnishing the services. Declines in
their APC relative payment weights can partially be attributable to
these changes in the degree to which the relative payment are
reflective of costs. As we have noted, there also may be additional
influencing factors that have led to those changes, including use of
actual rather than simulated claims data, the use of the new
``Implantable Medical Devices Charged to Patients'' standard cost
center, the corrections we made to our revenue code-to-cost center
modeling crosswalk in our data process, and others. We also note that,
because of budget neutrality, for each APC that commenters identified
as having decreased payments, there are other APCs that have increased
payments. As a general matter, we believe that, in their totality, the
newly based APC payment rates better reflect the underlying costs in
both cases.
We have typically analyzed the impacts of any proposals at the CPT
code, APC, and provider levels of granularity, as most hospitals
furnish a variety of services to Medicare beneficiaries. We do not
believe that observed declines or increases in the payments for codes
are typically associated with any individual specialty because, as we
have noted, there are both increases and decreases in relative payment
weight associated with this proposal. Additionally, changes generally
are due to the degree to which medians were insensitive to the range of
service costs.
Comment: One commenter expressed concern regarding the impact of
geometric means-based payment on blood products because many of the
blood product APCs would experience declines in payment. The commenter
recommended that blood products continue to be separately paid based on
simulated median costs or that a CY 2013 payment floor be set at the CY
2012 APC payment rates.
[[Page 68268]]
Response: While we appreciate the concerns expressed by the
commenter, we do not believe that it is appropriate to establish the
relative payment weights using different cost metrics for various APC
categories. Doing so would potentially distort the cost relativity and
APC payments of services paid through the OPPS. We note that, to ensure
that the cost estimation process for blood products is as accurate as
possible, we have continued to use simulated CCRs where appropriate, as
discussed under section II.A.d.2. of this final rule with comment
period. Similarly, we do not believe that setting a payment floor for a
specific set of services is appropriate. The estimated resource costs
associated with providing a service change from year to year and
establishing arbitrary payment floors would decrease the degree to
which APC payments reflect the range of costs associated with providing
a service.
Comment: Commenters also expressed concern regarding the use of
geometric mean costs as the basis for APC relative payment weights for
brachytherapy sources and recommended that they not be used in
establishing the relative payment weights. The commenters believed that
geometric mean costs would be inappropriate for use in ratesetting, in
particular for the case of brachytherapy sources.
One commenter stated that the geometric mean is inappropriate for
use in determining payment levels under the OPPS because it will
overemphasize the weight of low and potentially spurious values in the
data. The commenter had other statistical concerns regarding the extent
to which there were high-cost and low-cost outliers that they believed
were not plausible values as well as variation in estimated costs for
brachytherapy relative to other OPPS services. The commenter attributed
that variation as being due to hospital reporting practices, and
contrasted that variation in the OPPS to the IPPS, where the commenter
believed the main concern was high-cost outliers and high-cost values.
Under the commenter's belief that geometric means would pay
inadequately for brachytherapy, the commenter also believed it would
create a disincentive to use brachytherapy in the treatment of cancer
and create access to care issues. The commenter stated that CMS would
be acting contrary to the intent of the cost-based payment extensions
for brachytherapy payment from CY 2004 through CY 2009. Further, the
commenter stated that CMS did not provide sufficient warning to other
policymakers in CYs 2010 and 2011 regarding the likelihood that it
might potentially change the cost metric used to establish relative
payment weights. The commenter believed that geometric mean costs
should not be used to develop the relative payment weights of
brachytherapy sources.
Response: As with all other OPPS services that would be affected by
the proposed policy, we do not believe that the use of geometric mean
costs in establishing the APC relative payment weights for
brachytherapy sources is inappropriate. While the use of geometric mean
costs will include the weight of low values in the data, we note that
it also better incorporates cost observations from the higher values in
the data. This can be seen in the increases in the relative payment
weight for certain brachytherapy sources based on using geometric mean
costs. As discussed earlier in this section, the values now being
included could potentially include spurious values on both ends of the
dataset, as well as legitimate and accurate data. We believe that
encompassing a broader range of service costs in establishing the
relative payment weights is a technical improvement and may increase
the degree to which payments reflect the range of costs associated with
providing a service.
Both the IPPS and OPPS contain reporting variations due to the
different charging practices among hospitals. While we agree that some
of the variations in cost outlier values may be due to the fact that
brachytherapy sources rely on charges and costs associated with a CCR,
that does not imply that they are necessarily inappropriate, as all
OPPS payments rely on charges and CCRs. As we have noted earlier in
this section, as long as providers are using generally acceptable
accounting practices (GAAP), and the cost report structure reflects
their charging practices, we believe that this results in accurate
calculations. While the commenter has suggested that the variation in
the costs of brachytherapy sources is inappropriate, this can be
attributed to both accounting and real cost differences among the
various providers that furnish the service in addition to low frequency
of line items which may be used to model cost. Although medians may be
less sensitive to cost outliers, or even the range of costs, we believe
that is both a strength and a weakness of that metric, but is not a
reflection of greater or lesser accuracy. While commenters have
provided examples with a sample size of three values to illustrate
their point regarding sensitivity to low cost values, we note that
cases with this order of extreme observations used to model the
relative payment weights would be exceptionally rare. For example, the
commenter posited a reported charge of $0.01 which is not only
extremely unlikely but also is not supported by institutional claims
processing. In situations where there are few claims available to model
the service costs, the basic issue is the claims volume and their use
in establishing the relative payment weights, and not necessarily the
fact that medians or geometric means are used. We can address small
claim volumes in some cases through assigning similar services based on
resource costs or clinical similarity to the same APCs. However, this
method of addressing variability based on low claims volume is
unavailable as a tool for line item cost-based APCs.
We do not believe that changes in payment based on the use of
geometric mean costs will create a disincentive towards using
brachytherapy as a viable option in the treatment of cancer. As we
noted earlier in this section, there is variation even among the
brachytherapy APCs, which suggests that some of those APC payment rates
may now better reflect the range of costs associated with them. There
also is extreme variation in the costs reported by individual hospitals
for each service within the APC. In considering whether a median cost-
based system or a geometric mean-based system is more appropriate at
this juncture, the inclination is to view declines in payments as
aberrant, without consideration of increases in payment. However, it is
equally possible that medians and their lack of sensitivity towards
outliers may have led to more payments based on overstated costs than
would have been appropriate when considering the broader range of
service costs. As discussed in an earlier response, we will continue to
monitor the impact of this proposal to base the relative payment
weights on geometric mean costs.
With respect to the comments regarding the process through which we
establish payment policy for each prospective payment year, we note
that the OPPS rulemaking process occurs annually, and is intended to
give providers notice as well as the opportunity to inform rulemaking
and express their stances regarding various policy proposals. While
being able to prepare for each rulemaking cycle so that each
prospective payment policy proposal is known years in advance may be
preferred by commenters, it is not operationally feasible. As we have
discussed in this section, as well as in the CY 2013 OPPS/ASC proposed
rule,
[[Page 68269]]
the situations that were pressing during the inception of the initial
OPPS, and the changes we have made since then, have allowed us to
consider different issues as well as areas for improvement. We believe
that basing the relative payment weights on geometric mean costs is one
such improvement. Although Congress did extend the prior cost-based
methodology for brachytherapy sources from CYs 2004 through 2009, we
note that no such additional extension has been enacted. Further, the
discretion to use a median-based or mean-based system in establishing
the OPPS relative payment weights predates those extensions, as
authorized by section 201(f) of the BBRA of 1999.
While we recognize the concerns regarding the payments for
brachytherapy sources based on geometric mean costs, we continue to
believe that this change will result in more accuracy in the cost
estimation. We do not believe that paying for some services based on
median costs while using geometric mean costs for other services is
appropriate, equitable, or consistent with statute. Further, using
different cost metrics for different services could distort the
relativity of services within the system and increase the inaccuracy
and instability of service payment.
Comment: Several commenters noted that they had difficulty modeling
the budget neutrality and impact calculations, and suggested that CMS
provide a more thorough explanation before proceeding with the proposal
to establish OPPS relative payment weights based on geometric mean
costs. The commenters stated that lack of a study, in particular one
that studies the effect of using geometric mean costs as the basis for
the relative payment weights over time, made it difficult for them to
make an informed decision. The commenters also stated that an
explanation regarding the impacts was necessary before proceeding, with
several commenters noting that the effect of basing the relative
payment weights on geometric mean costs was not evenly distributed by
provider types. One commenter disagreed that there would generally be
limited financial impact to hospitals, due to the fluctuations in
certain APCs. Some commenters claimed that the proposal to base the
relative payment weights on geometric mean costs disproportionately
affected teaching hospitals. Other commenters asked CMS to provide a
list of APCs whose costs fluctuated above a certain threshold each
year, so that those APCs could be identified through rulemaking for
public comment and to allow for presentations before the HOP Panel. A
few commenters expressed concern in using geometric mean costs for
small sample sizes, as was the case with those associated with proton
beam therapy.
Response: For the past several years, each OPPS/ASC rule has
included a discussion summarizing both our data process, as well as the
calculations associated with budget neutrality and hospital impacts.
However, we also make available online a claims accounting document
that summarizes in great detail the claims manipulation that goes into
modeling the costs used to develop the relative payment weights, as
well as the calculations and data processes used to model budget
neutrality and the hospital impacts each cycle. The budget neutrality
and hospital impacts portions of this document were developed beginning
with the CY 2007 OPPS proposed rule, and have been available for every
OPPS rulemaking cycle thereafter.
While we appreciate the concerns that commenters have with regard
to studying the effects over time, we believe that any increased
fluctuations due to geometric mean-based payments are generally not
significant enough to create cause for concern. This data process
change applied to the cost metric used to develop the relative payment
weights more fully captures the range of costs associated with
providing a service. However, service costs and APC payments fluctuate
over time for a variety of reasons, as we have previously discussed in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74139). As
we have discussed earlier in this section, we will continue to monitor
the impact of using geometric mean costs to establish the APC relative
payment weights and any changes in service frequency or beneficiary
access. Our investigation into the impact of using geometric mean costs
to establish the relative payment weights also suggest that there
should be limited volatility in the payment rates after this initial
change. We note that some services do have payment decreases associated
with using geometric mean-based relative weights. However, many
services also experience payment increases as a result of the geometric
mean-based calculation, presumably because the relative payment weights
more accurately reflect higher costs associated with provisions of
those services. Finally, we note that the one-time effect of converting
from medians to means this year is not to be confused with the much
less significant effect of year-to-year variation associated with
means.
We agree with the commenters' concern regarding the issue of APCs
with small sample sizes. However, our concern has less to do with the
use of geometric mean costs being used to model the relative payment
weights where they are appropriate, but more with the degree to which a
substantive cost baseline can be established. In general, APCs with
relatively low service costs or those where there is low claims volume
tend to be more vulnerable to cost and payment volatility. We continue
to examine methods and APC configurations, such as larger bundles, to
mitigate any concerns related to those issues. As the commenter
discussed regarding the case of proton beam therapy, there are
situations where the costs of the service reflect only provision from a
small number of providers and, therefore, may not establish a broad
baseline as is the case for most APCs. However, in the case of the
proton beam APCs, a sufficiently large volume of claims had been
provided and the geometric means helped carry out our intention of
capturing the full range of costs. As discussed in the APC-specific
policy section of this final rule with comment period, section II.D.,
the issues relayed by the commenter primarily were due to presumed
idiosyncrasies and errors in the submission of the cost reports, which,
in turn, affected the estimation of costs, and was further impacted by
the coding practices at an individual provider. We note that the
potential of these issues to affect the relative payment weights would
occur both under a median-based system, provided there was enough
significant volume, as well as under geometric mean costs.
In both the CY 2013 OPPS/ASC proposed rule and in this CY 2013
OPPS/ASC final rule with comment period, we have included a column in
the impact tables that separately shows the effects of the use of
geometric mean costs on the APC relative payment weights. At a very
basic level, provider categories that experienced more significant
negative or positive payment impacts did so because of the mix of
services furnished by those providers based on our claims data. We note
that the OPPS provider payment impacts identified in section XXIII. of
this CY 2013 OPPS/ASC final rule are relatively limited. Some
commenters have stated that the policy of developing relative payment
weights using geometric mean costs disproportionately affects teaching
hospitals; other commenters have noted that the impacts are not
identical based on the provider categories. That differential in the
impacts is to be
[[Page 68270]]
expected based on this policy, just as any estimated payment impact
based on the mix of services that a hospital provides will vary from
year to year. Because this policy affects the calculation of the
relative payment weights and does not affect the relative payment
weights uniformly, it is natural for the changes in those weights to
have corresponding variation reflected in the provider impacts based on
the mix of services furnished by providers. In the provider impact
table in this CY 2013 OPPS/ASC final rule with comment period, we note
that, even among major and minor teaching hospitals, there are
different estimated impacts based on this policy. We further note that,
while the payment category may reflect an increase or decrease in total
estimated payment, even among the hospitals in that category, there may
be differential impacts that may not necessarily be in the same
direction. As discussed earlier in this section, we will continue to
monitor any changes that may be associated with the policy of
calculating the relative payment weights using geometric mean costs.
We make available with each proposed rule and final rule cost
statistics files that include information about costs by CPT code and
APC, as well as modeling and total frequency information for each code.
Addenda A and B which show the payment rates associated with each rule,
also are made available on the CMS Web site. Therefore, the information
to continue monitoring changes in APC payment, code frequency, and cost
are made available to the public.
Comment: One commenter supported the goal of making cross-system
payment comparison of payment parity. Two commenters cautioned against
using OPPS payments based on geometric mean costs as a basis for
examining payment parity across the prospective payment systems. They
noted that other factors may be involved that would cause those
comparisons to potentially be inappropriate, including the acuity of
the patients, case-mix, ratesetting methodologies, and resource use in
different care settings, as well as different payment adjustments in
each system.
Response: While we believe that each of the payment systems has an
internally consistent methodology, we recognize the value of including
useful information in making potential payment comparisons. We note
that we already implement cross-system payment and utilization
comparisons in cases such as the MPFS DRA imaging cap, the ASC cap on
separately payable radiology services, the cap on ASC office-based
covered surgical procedures, and the comparison of service provision
across settings for purposes of the inpatient list. The goal in making
any potential payment comparisons is to analyze the differences and
similarities in as appropriate a manner as possible.
As we discussed in the CY 2012 OPPS/ASC final rule with comment
period, in the context of the proposed Cardiac Resynchronization
Therapy composite APC, there are various goals associated with making
cross-system payment comparisons, including ensuring that we do not
create an inappropriate payment incentive to provide services in one
setting of care as opposed to another, using more accurate information
where it is available, and constructing the payment groups to be more
clinically and resource similar to each other where appropriate, among
others (76 FR 74179 through 74182). We specifically noted that there
could be many payment approaches that could be chosen for comparison
purposes for any given item or service (76 FR 74181).
After consideration of the public comments we received, we are
finalizing our proposal to develop the APC relative payment weights
using geometric mean costs in the manner described above.
As we also discussed in the CY 2013 OPPS/ASC proposed rule (77 FR
45097), under the revised ASC payment system that was effective January
1, 2008, we established a standard ASC ratesetting methodology that
bases payment for most ASC covered surgical procedures and some covered
ancillary services on the OPPS relative payment weights (72 FR 42491
through 42493). Therefore, because we proposed to calculate CY 2013
OPPS relative payment weights using geometric mean costs, we also
proposed that CY 2013 ASC payment rates under the standard ASC
ratesetting methodology would be calculated using the OPPS relative
payment weights that are based on geometric mean costs. We noted that
basing the relative payment weights on geometric mean costs rather than
median costs affects the proposed CY 2013 payment rates. We stated that
differences in the proposed payment rates, as with any changes from
year to year, affect other parts of the OPPS, including the copayments
described in section II.I. of the proposed rule as well as the fixed-
dollar outlier threshold described in section II.G. of the proposed
rule.
We did not receive any public comments on the adoption of OPPS
relative payment weights based on geometric means in the ASC system.
For a more detailed discussion of the ASC ratesetting methodology, we
refer readers to section XIV. of this final rule with comment period.
Under the CY 2013 proposed policy to base the relative payment
weights on geometric mean costs, we also proposed to revise the related
regulations that currently reflect a median cost-based OPPS to instead
reflect a geometric mean cost-based OPPS. Specifically, we proposed to
revise 42 CFR 419.31, which describes the 2 times rule discussed in
section III.B. of the proposed rule and this final rule with comment
period and the development of relative payment weights based on the
cost metrics discussed in section II.A.4 of the proposed rule and this
final rule with comment period.
Comment: One commenter stated that CMS did not address why it did
not apply the 2 times rule based on geometric means while continuing to
use medians for calculating the relative weights because the commenter
believed that it would improve the detection of changes in service cost
while basing relative payment weights on the less volatile median.
Response: In the CY 2013 OPPS/ASC proposed rule, we discussed the
impact of evaluating the 2 times rule based on geometric mean costs
rather than median costs, noting that while doing so did not
significantly affect the application of the rule, it created several
additional 2 times rule violations in the rebasing process (77 FR
45097). Similar to the IPPS and since the inception of the OPPS, we
have used a statistical outlier trim of three standard deviations
beyond the geometric mean cost, even though we have historically used
median costs as the metric on which to base the relative payment
weights. The application of the 2 times rule is inherently tied to the
configuration of the APCs and, therefore, how individual codes are
paid. To apply the 2 times rule based on geometric mean cost and
reconfigure the APCs based on that metric, while calculating relative
payment weights based on medians, would be an inconsistency in the data
process in the same way that using geometric mean costs for some
services and median costs for others would be. Further, section
1833(t)(2) of the Act states that the application of the 2 times rule
should be based on the metric selected in section 1833(t)(2)(C) of the
Act.
After consideration of the public comments we received, we are
finalizing our proposal to apply the 2 times rule based on geometric
mean costs and the corresponding changes in 42 CFR 419.31.
[[Page 68271]]
In section XXII. of this final rule with comment period, which
discusses the regulatory impact analysis, we are providing an
additional column in the impact tables for the OPPS that identifies the
estimated impact due to APC recalibration of a geometric means-based
OPPS as well as a column that estimates the impact of recalibration
based on CY 2011 claims and historical cost report data. As depicted in
the impact tables, many provider categories will experience limited
impacts under the final policy to base the OPPS relative payment
weights on geometric means. We note that the impact tables only
estimate the OPPS payment impact based on the most current available
claims and cost report data, and that providers' actual payments may
vary, depending on the mix of services provided in the actual claims
year. Also, the budget neutral payment adjustments ensure that, under a
geometric mean-based system or a median cost-based system, aggregate
OPPS payments will remain the same.
Section XXII. of this final rule with comment period contains an
OPPS provider impact table that estimates the effect of policy changes
and budget neutrality adjustments on provider payment under the CY 2013
OPPS. Column 3 of the impact table shows the estimated impact by
provider category of calculating the CY 2013 OPPS payments based on
geometric mean costs rather than median costs. While the policy to
shift the basis for relative payment weights to geometric mean costs
may involve some changes to the relative weights on which OPPS payments
are based, providers will generally experience limited impacts to
payment as a result of the CY 2013 final policy. Those provider
categories that are estimated to experience increased payments as a
result of the policy to base the CY 2013 relative payment weights on
geometric mean costs generally included non-IPPS hospitals that
provided psychiatric, hospital-based PHPs, and other services whose
relative payment weights increased based on geometric mean costs. As
noted above, we recognize that there may be fluctuations in the
relative payment weights based on this CY 2013 final policy, but we
believe that this policy represents an improvement that more accurately
estimates the costs associated with providing services.
In our experience developing the OPPS, we have implemented many
changes to obtain more cost information from the claims and cost report
data available to us, in an effort to arrive at more accurate estimates
of service cost. Many of those changes are described above and in prior
OPPS final rules. Despite the challenges created by the complexity of
the data and the diversity of facility accounting systems, we continue
to examine possible process and data changes that may further improve
precision, validity, and utility. Commenters have historically
expressed concerns about the degree to which OPPS relative payment
weights are reflective of the service costs associated with providing
them, APC payment rate volatility from year to year, and other cost
modeling related issues. We recognize that some of those issues will
remain because they are related to naturally occurring changes in the
economic environment, clinical practice, and the nature of payment
systems, among other reasons. However, we believe that basing the OPPS
relative payment weights on geometric means better captures the range
of costs associated with providing services, improves payment accuracy
while limiting year-to-year volatility, and allows reconfigurations in
the APC environment using a metric that provides greater computational
depth. For these reasons, and those discussed above, we are basing the
CY 2013 OPPS/ASC final relative payment weights on geometric mean
costs.
3. Changes to Packaged Services
a. Background
Like other prospective payment systems, the OPPS relies on the
concept of averaging, where the payment may be more or less than the
estimated cost of providing a specific service or bundle of specific
services for a particular patient. However, with the exception of
outlier cases, overall payment is adequate to ensure access to
appropriate care. The OPPS packages payment for multiple interrelated
services into a single payment to create incentives for providers to
furnish services in the most efficient way by enabling hospitals to
manage their resources with maximum flexibility, thereby encouraging
long-term cost containment. For example, where there are a variety of
supplies that could be used to furnish a service, some which are more
expensive than others, packaging encourages hospitals to use the most
cost-efficient item that meets the patient's needs, rather than to
routinely use a more expensive item, which could result if separate
payment is provided for the items. Packaging also encourages hospitals
to negotiate with manufacturers and suppliers to reduce the purchase
price of items and services or to explore alternative group purchasing
arrangements, thereby encouraging the most economical health care.
Similarly, packaging encourages hospitals to establish protocols that
ensure that necessary services are furnished, while scrutinizing the
services ordered by practitioners to maximize the efficient use of
hospital resources. Packaging payments into larger payment bundles
promotes the predictability and accuracy of payment for services over
time. Finally, packaging may reduce the importance of refining service-
specific payment because packaged payments include costs associated
with higher cost cases requiring many ancillary services and lower cost
cases requiring fewer ancillary services. For these reasons, packaging
payment for items and services that are typically ancillary and
supportive to a primary service has been a fundamental part of the OPPS
since its implementation in August 2000.
We use the term ``dependent service'' to refer to the HCPCS codes
that represent services that are typically ancillary and supportive to
a primary diagnostic or therapeutic modality. We use the term
``independent service'' to refer to the HCPCS codes that represent the
primary therapeutic or diagnostic modality into which we package
payment for the dependent service. In future years, as we consider the
development of larger payment groups that more broadly reflect services
provided in an encounter or episode of care, it is possible that we
might propose to bundle payment for a service that we now refer to as
``independent.''
We assign status indicator ``N'' to those HCPCS codes of dependent
services that we believe are always integral to the performance of the
primary modality; therefore, we always package their costs into the
costs of the separately paid primary services with which they are
billed. Services assigned to status indicator ``N'' are unconditionally
packaged.
We assign status indicator ``Q1'' (STVX-Packaged Codes), ``Q2'' (T-
Packaged Codes), or ``Q3'' (Codes that may be paid through a composite
APC) to each conditionally packaged HCPCS code. An STVX-packaged code
describes a HCPCS code whose payment is packaged with one or more
separately paid primary services with the status indicator of ``S,''
``T,'' ``V,'' or ``X'' furnished in the hospital outpatient encounter.
A T-packaged code describes a code whose payment is only packaged with
one or more separately paid surgical procedures with the status
indicator of ``T'' are provided during the hospital outpatient
encounter. STVX-packaged codes and T-packaged codes are paid separately
in those uncommon cases when they do not meet their
[[Page 68272]]
respective criteria for packaged payment. STVX-packaged codes and T-
packaged codes are conditionally packaged. We refer readers to section
XII.A.1. of this final rule with comment period and Addendum D1, which
is available via the Internet on the CMS Web site with other Addenda,
for a complete listing of status indicators and the meaning of each
status indicator.
Hospitals include HCPCS codes and charges for packaged services on
their claims, and the estimated costs associated with those packaged
services are then added to the costs of separately payable procedures
on the same claims to establish prospective payment rates. We encourage
hospitals to report all HCPCS codes that describe packaged services
provided, unless the CPT Editorial Panel or CMS provides other
guidance. The appropriateness of the OPPS payment rates depends on the
quality and completeness of the claims data that hospitals submit for
the services they furnish to Medicare beneficiaries.
In addition to the packaged items and services listed in 42 CFR
419.2(b), in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66610 through 66659), we adopted the packaging of payment for items and
services in seven categories with the primary diagnostic or therapeutic
modality to which we believe these items and services are typically
ancillary and supportive. The seven categories are: (1) Guidance
services; (2) image processing services; (3) intraoperative services;
(4) imaging supervision and interpretation services; (5) diagnostic
radiopharmaceuticals; (6) contrast media; and (7) observation services.
We specifically chose these categories of HCPCS codes for packaging
because we believe that the items and services described by the codes
in these categories are typically ancillary and supportive to a primary
diagnostic or therapeutic modality and, in those cases, are an integral
part of the primary service they support. Packaging under the OPPS also
includes composite APCs, which are described in section II.A.2.e. of
this final rule with comment period.
We recognize that decisions about packaging and bundling payment
involve a balance between ensuring that payment is adequate to enable
the hospital to provide quality care and establishing incentives for
efficiency through larger units of payment. Therefore, in the CY 2013
OPPS/ASC proposed rule (77 FR 45098 through 45101), we invited public
comments regarding our packaging proposal for the CY 2013 OPPS.
b. Clarification of the Regulations at 42 CFR 419.2(b)
In the CY 2013 OPPS/ASC proposed rule (77 FR 45099), we proposed to
clarify the regulatory language at 42 CFR 419.2(b) to make explicit
that the OPPS payments for the included costs of the nonexclusive list
of items and services covered under the OPPS referred to in this
paragraph are packaged into the payments for the related procedures or
services with which such items and services are provided. We stated
that this proposed clarification is consistent with our interpretation
and application of 42 CFR 419.2(b) since the inception of the OPPS. We
invited public comments on this clarification.
Comment: One commenter objected to the proposed clarification of
the regulatory language at 42 CFR 419.2(b). The commenter expressed
concern that the proposed changes to the regulatory language are
ambiguous and may result in confusion for hospitals and contractors.
The commenter believed that Medicare audit contractors will try to
assert that all services furnished during a particular encounter, such
as E/M visits, drug administration, X-rays, or other ancillary tests,
are all related to the main procedure or service received. The
commenter further stated that this may lead to payment denials or
monies taken during audits and/or post-payment reviews based on the
proposed clarification. Therefore, the commenter recommended that CMS
abandon this proposal because the current regulatory language is clear
and instructs all entities about CMS' packaging principles.
Another commenter did not object to the proposed wording change
from ``included costs'' to ``packaged costs'' because, the commenter
stated, CMS did not propose to add or alter any of the examples of
packaged items and services, and the language used already notes that
the list provided is not an inclusive one. However, the commenter was
concerned that the proposed addition of the phrase ``the payments for
which are packaged into the payment for the related procedures or
services'' introduces a new concept that may lead to a broad
interpretation of the regulatory text. The commenter expressed concern
that when audits of OPPS accounts occur, the proposed regulatory text
may be used to broaden the packaging concept beyond accurate CPT coding
by using a subjective interpretation of the term ``related''.
Therefore, the commenter requested that CMS not add the phrase ``the
payments for which are packaged into the payment for the related
procedures or services''.
Response: We disagree with the commenters' assertion that the
proposed clarification of the regulatory text at 42 CFR 419.2(b) is
ambiguous or confusing. We note our proposal simply clarifies our
longstanding policy of packaging, which is a fundamental concept of the
OPPS. Specifying that included costs are packaged under the OPPS and
that the payment for these packaged costs is packaged into the payment
of the related procedures or services is consistent with our
longstanding policies related to packaging. In addition, we disagree
with the commenter's statement that the proposed addition to 42 CFR
419.2(b) of the phrase ``the payment for which are packaged into the
payment for the related procedures or services'' introduces a new
concept into the current regulation text.
As we have repeatedly stated, since the inception of the OPPS,
packaging payment for items and services that are typically ancillary
and supportive to a primary service has been a fundamental part of the
OPPS. The concept of packaging entails that the costs for packaged
services that are billed with a status indicator of ``N'' are packaged
into the costs of the separately paid primary service with which they
are billed. This then means that no separate APC payment is made for
the packaged service alone but payment is instead included in the
payment for the service or procedure with which the packaged service
has been billed.
We believe that our clarification of the regulations at 42 CFR
419.2(b) is consistent with the concept of packaging under the OPPS and
does not deviate in any way from our current and longstanding policies
regarding packaging under the OPPS.
After consideration of the public comments we received, we are
finalizing our proposed policy, without modification, to clarify 42 CFR
419.2(b) to make explicit that the OPPS payments for the included costs
of the nonexclusive list of items and services covered under the OPPS
referred to in this paragraph are packaged into the payments for the
related procedures or services with which such items and services are
provided.
c. Packaging Recommendations of the HOP Panel (``The Panel'') at Its
February 2012 Meeting
During its February 2012 meeting, the Panel made five
recommendations related to packaging and to the function of the
subcommittee. One additional recommendation that originated from
[[Page 68273]]
the APC Groups and Status Indicator (SI) Assignment Subcommittee about
observation services is discussed in section II.A.2.e. of this final
rule with comment period. The report of the February 2012 meeting of
the Panel may be found on the CMS Web site at: http://www.cms.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp.
Below we present each of the Panel's five packaging recommendations
and our responses to those recommendations.
Panel Recommendation: CMS should delete HCPCS code G0259 (Injection
procedure for sacroiliac joint; arthrography) and HCPCS code G0260
(Injection procedure for sacroiliac joint; provision of anesthetic,
steroid and/or other therapeutic agent, with or without arthrography),
and instead use CPT code 27096 (Injection procedure for sacroiliac
joint, anesthetic/steroid, with image guidance (fluoroscopy or CT)
including arthrography, when performed) with a status indicator of
``T,'' and assign CPT code 27096 to APC 0207 (Level III Nerve
Injections).
Response: In the CY 2013 OPPS/ASC proposed rule, we did not accept
the Panel's recommendation to delete HCPCS code G0259 and G0260 and
instead use CPT code 27096 with a status indicator of ``T'' and assign
CPT code 27096 to APC 0207. For CY 2012, we assigned CPT code 27096 to
status indicator ``B,'' meaning that this code is not payable under the
OPPS. In order to receive payment for procedures performed on the
sacroiliac joint with or without arthrography or with image guidance
under the OPPS, hospitals must use either HCPCS code G0259, which is
assigned to status indicator ``N'' for CY 2012, or HCPCS code G0260,
which is assigned to status indicator ``T'' for CY 2012, as
appropriate. CMS created HCPCS codes G0259 and G0260 to separate and
distinguish the image guidance procedure from the therapeutic injection
procedure for the sacroiliac joint. As stated above, guidance
procedures are packaged under the OPPS because we believe that they are
typically ancillary and supportive to a primary diagnostic or
therapeutic modality and are an integral part of the primary service
they support.
We believe that the existence of HCPCS codes G0259 and G0260 is
necessary to assign appropriate packaged payment for the image guidance
procedure, according to our established packaging policy, and separate
payment for the therapeutic injection procedure. Therefore, we did not
accept the Panel's recommendation and followed the previously
established policy to continue to assign HCPCS code G0259 to status
indicator ``N,'' HCPCS code G0260 to status indicator ``T,'' and CPT
code 27096 to status indicator ``B'' for CY 2013.
Comment: Several commenters disagreed with CMS' proposal to not
accept the Panel's recommendation on HCPCS codes G0259 and G0260 and to
continue to assign a status indicator of ``B'' for CPT code 27096. One
commenter expressed concern that the continued use of HCPCS codes G0259
and G0260 instead of the CPT code 27096 is administratively burdensome
to hospitals because it does not allow standardized code reporting
among all payers.
Another commenter stated that there is no CPT code that would
describe the radiological portion of the procedure to be reported in
addition to HCPCS code G0259 because the AMA deleted CPT code 73054. As
of January 1, 2012, the commenter stated that CPT code 27096 is always
a complete procedure that includes the injection of a diagnostic or
therapeutic agent and the associated imaging. The commenter recommended
that CMS recognize CPT code 27096 and assign the appropriate APC code
to this CPT code based on the CY 2011 claims data for HCPCS code G0259
with CPT code 73542 and HCPCS code G0260 or modify the descriptor of
HCPCS code G0259 to include the radiological portion of the procedure
and assign the appropriate status indicator and APC for the complete
procedure.
One commenter stated that CPT codes 77003 (Fluoroscopic guidance
and localization of needle or catheter tip for spine or paraspinous
diagnostic or therapeutic injection procedures (epidural or
subarachnoid)) and 77012 (Computed tomography guidance for needle
placement (eg, biopsy, aspiration, injection, localization device),
radiological supervision and interpretation) that are billed with HCPCS
code G0260 have a NCCI edit with an indicator of ``1.'' Therefore, the
commenter stated that CPT codes 77003 and 77012 cannot be reported with
modifier ``59'' because the imaging guidance is not separate and
distinct and it is instead part of the procedure. The commenter stated
that providers cannot accurately report the cost of the imaging
guidance (either fluoroscopy or CT) due to the CCI edits and the fact
that the HCPCS code G0260 descriptor does not indicate if either
fluoroscopy or CT imaging is bundled into the procedure code.
Therefore, the commenter asked that CMS establish a new HCPCS code to
describe the sacroiliac injection procedure performed with imaging
(fluoroscopy or CT) or allow the reporting of CPT code 27096 and revise
the status indicator from ``B'' to ``T.''
Response: We continue to believe that assigning HCPCS codes G0259
to status indicator ``N'' is necessary in order to designate
appropriate packaged payment for the image guidance procedure,
according to our established packaging policy, and separate payment for
the therapeutic injection procedure. However, we will reevaluate the
descriptors for HCPCS code G0259 and G0260 for CY 2014 in light of the
commenter's concerns on the AMA's modification of the descriptor for
CPT code 27096 in CY 2012 to include the arthrography services
described by CPT code 73542.
After consideration of the public comments we received, for CY
2013, we are continuing to assign a status indicator of ``N'' to HCPCS
code G0259, a status indicator of ``T'' to HCPCS code G0260, which is
assigned to APC 0207 with a final CY 2013 geometric mean cost of
approximately $582, and a status indicator of ``B'' to CPT code 27096.
Panel Recommendation: CMS provide data to the APC Groups and SI
Subcommittee on the following arthrography services, so that the
Subcommittee can consider whether the SI for these services should be
changed from ``N'' to ``S'':
HCPCS code 21116 (Injection procedure for
temporomandibular joint arthrography);
HCPCS code 23350 (Injection procedure for shoulder
arthrography or enhanced CT/MRI shoulder arthrography);
HCPCS code 24220 (Injection procedure for elbow
arthrography);
HCPCS code 25246 (Injection procedure for wrist
arthrography);
HCPCS code 27093 (Injection procedure for hip
arthrography; without anesthesia);
HCPCS code 27095 (Injection procedure for hip
arthrography; with anesthesia);
HCPSC code 27096 (Injection procedure for sacroiliac
joint, anesthetic/steroid with image guidance (fluoroscopy or CT)
including arthrography when performed);
HCPCS code 27370 (Injection procedure for knee
arthrography); and
HCPCS code 27648 (Injection procedure for ankle
arthrography).
CMS Response: In the CY 2013 OPPS/ASC proposed rule, we accepted
the Panel's recommendation that CMS provide data to the APC Groups and
SI Assignment Subcommittee on CPT codes 21116, 23350, 24220, 25246,
27093, 27095, 27096, 27370, and 27648 at a future Panel meeting.
[[Page 68274]]
We did not receive any public comments on this recommendation.
Panel Recommendation: CMS change the status indicator for HCPCS
code 19290 (Preoperative placement of needle localization wire, breast)
from ``N'' to ``Q1'' and continue to monitor the frequency of the code
when used in isolation.
CMS Response: In the CY 2013 OPPS/ASC proposed rule, we agreed with
the Panel that a status indicator of ``Q1'' is appropriate for CPT code
19290. This status indicator will allow for separate payment when this
procedure is performed alone or packaged payment when this procedure is
performed with an associated surgical procedure. Therefore, as we
proposed, we are accepting the Panel's recommendation and assigning CPT
code 19290 to APC 0340 (Minor Ancillary Procedures) and status
indicator ``Q1'' for the CY 2013 OPPS. APC 0340 has a final geometric
mean cost of approximately $51 (as compared to approximately $50
calculated for the proposed rule) for CY 2013.
Comment: Several commenters supported CMS' proposal to reassign
HCPCS code 19290 from ``N'' to ``Q1''. However, one commenter
recommended that CMS review the APC assignments for HCPCS codes 19290
and 19295 (Image guided placement, metallic localization clip,
percutaneous, during breast biopsy/aspiration (list separately in
addition to code for primary procedure) during the CY 2014 rulemaking
cycle and propose a more appropriate and higher paying APC for these
services.
Response: We appreciate the commenters' support. For CY 2013, we
are accepting the Panel's recommendation and finalizing our proposal to
assign a status indicator of ``Q1'' to HCPCS code 19290, which is
assigned to APC 0340 with a CY 2013 final payment rate of approximately
$51. As has been our practice since the implementation of the OPPS in
2000, we review, on an annual basis, the APC assignments for the
procedures and services paid under the OPPS. We will continue to
review, on an annual basis, the APC assignments for CPT codes 19290 and
19295.
Panel Recommendation: Judith Kelly, R.H.I.T., R.H.I.A., C.C.S.,
remain the chair of the APC Groups and SI Subcommittee.
CMS Response: In the CY 2013 OPPS/ASC proposed rule, we indicated
that we accepted the Panel's recommendation that Judith Kelly,
R.H.I.T., R.H.I.A., C.C.S., continue to chair the APC Groups and SI
Assignment Subcommittee.
We did not receive any public comments on this recommendation. We
appreciate the services of Ms. Kelly as chair of the Subcommittee for
CY 2012.
Panel Recommendation: The work of the APC Groups and SI Assignment
Subcommittee continue.
CMS Response: In the CY 2013 OPPS/ASC proposed rule, we indicated
that we accepted the Panel's recommendation that the work of the APC
Groups and SI Assignment Subcommittee continue.
We did not receive any public comments on this recommendation.
d. Packaging Recommendations of the HOP Panel (``The Panel'') at Its
August 2012 Meeting
During its August 2012 meeting, the Panel accepted the report of
the Subcommittee for APC Groups and Status Indicator (SI) Assignments,
heard several public presentations related to packaged services and APC
grouping and status indicator assignments, and made two recommendations
related to the function of the subcommittee. The subcommittee also made
recommendations with regard to APC assignment of specific services that
are discussed in section III.D. of this final rule with comment period.
The report for the August 2012 meeting of the Panel may be found on the
CMS Web site at: http://www.cms.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp.
Below we present the two recommendations related to the function of
the subcommittee. Recommendations that evolved from the discussions of
the Subcommittee on APC Groups and SI Assignments that are specific to
the APC assignment of HCPCS codes and the removal of HCPCS codes from
the inpatient list are discussed in section III. and IX., respectively,
of this final rule with comment period.
Panel Recommendation: The Panel recommends that Jacqueline Phillips
be named chair of the APC Groups and SI Assignments Subcommittee.
CMS Response: We accept the Panel's recommendation that Jacqueline
Phillips be named chair of the APC Groups and SI Assignments
Subcommittee. We thank Ms. Judith Kelly for her service as chair of the
APC Groups and SI Assignments Subcommittee, and we welcome Ms. Phillips
as chair of the APC Groups and SI Assignments Subcommittee.
Panel Recommendation: The Panel recommends that the work of the APC
Groups and SI Assignments Subcommittee continue.
CMS Response: We are accepting the APC Panel's recommendation that
the work of the APC Groups and SI Assignments Subcommittee continue.
e. Other Packaging Proposals and Policies for CY 2013
The HCPCS codes that we proposed to be packaged either
unconditionally (for which we continue to assign status indicator
``N''), or conditionally (for which we continue to assign status
indicator ``Q1'', ``Q2'', or ``Q3''), were displayed in Addendum B of
the CY 2013 OPPS/ASC proposed rule. The supporting documents for the CY
2013 OPPS/ASC proposed rule, including but not limited to Addendum B,
are available at the CMS Webs site at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. To
view the status indicators by HCPCS code in Addendum B, select ``CMS
1589'' and then select the folder labeled ``2013 OPPS Proposed Rule
Addenda'' or ``2013 OPPS Final Rule with Comment Period Addenda'' from
the list of supporting files. Open the zipped file and select Addendum
B, which is available as both an Excel file and a text file.
Comment: Commenters stated that CMS' packaging policies would
likely lead to less efficient use of resources, limited access to
innovative treatment options, and greater instability in payment
because the policies are based on several flawed assumptions. The
commenters believed that, to the extent that hospitals control the
array of services they provide, CMS' packaging policies assume that the
same incentives apply to services furnished in HOPDs as to inpatient
services. One commenter stated that, under the IPPS, hospitals have an
incentive to provide care in an efficient manner to ensure the lowest
cost for the patient's diagnosis. In contrast, in HOPDs, because
Medicare payment is based on procedures rather than diagnoses, the
commenter believed that hospitals have an incentive to provide the
lowest cost item or service included in an APC. The commenter further
believed that if that service does not fully address the patient's
needs, the hospital would receive better payment by bringing the
patient back for a second visit or admitting the patient for inpatient
care than by providing a more costly option within the same APC.
Moreover, the commenters believed that when an APC's payment rate
is significantly less than the cost of a technology, hospitals have a
strong disincentive to use that technology, even if it could reduce the
costs of care at a later date. The commenters believed
[[Page 68275]]
that CMS' use of expanded packaging has the risk of encouraging
hospitals to forego performing needed services and using new
technologies that may be more resource intensive during one visit, but
could save the patient future outpatient department visits or inpatient
care.
Response: As we stated in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74186), packaging payment for items and services
that are ancillary to and dependent on the major procedure for which a
payment rate is established is a fundamental concept of the OPPS, based
in regulation in the definition of costs that are included in the
national payment rate for a service (42 CFR 419.2(b)) and in place
since the inception of the OPPS (65 FR 18447). We continue to believe
that packaging creates incentives for hospitals and their practitioner
partners to work together to establish appropriate protocols that
eliminate unnecessary services where they exist and institutionalize
approaches to providing necessary services more efficiently. With
respect to new services or new applications of existing technology, we
believe that packaging payment for ancillary and dependent services
creates appropriate incentives for hospitals to consider whether a new
service or a new technology offers a benefit that is sufficient to
justify the cost of the new service or new technology. Whether this
review results in reductions in services that are only marginally
beneficial or influences hospitals' choices to not utilize certain
technologies, we believe that these changes could improve, rather than
harm, the quality of care for Medicare beneficiaries because every
service furnished in a hospital carries some level of risk to the
patient and the beneficiary would be spared the risk associated with
the additional service or different technology. Moreover, we believe
that hospitals strive to provide the best care they can to the patients
they service so that when new technologies are proven to improve the
quality of care, their utilization will increase appropriately, whether
the payment for them is packaged or not. While we believe hospitals are
committed to provide optimal care to their patients, we are aware that
there are financial pressures on hospitals that might motivate some
hospitals to split services among different hospital encounters in such
a way as to maximize payments. While we do not expect that hospitals
would routinely change the way they furnish services or the way they
bill for services in order to maximize payment, we recognize that it
would be possible and we consider that possibility as we annually
review hospital claims data. We will continue to examine claims data
for patterns of fragmented care, and if we find a pattern in which a
hospital appears to be dividing care across multiple days, we will
refer it for investigation to the QIO or to the Program Safeguard
Contractor, as appropriate to the circumstances we find.
Comment: One commenter stated that continued reporting by CMS on
utilization of all packaged services and access to care will be
essential to ensure that Medicare's payment policies do not restrict
beneficiaries' access to necessary care. The commenter asked that CMS
make annual reports to the HOP Panel on reporting of services subject
to CMS' expanded packaging services.
Response: Each year, we make available an extensive amount of OPPS
data that can be used for any data analysis an interested party would
care to perform. Specifically, we make available a considerable amount
of data for public analysis each year through the supporting data files
that are posted on the CMS Web site in association with the proposed
and final rules. In addition, as we discuss in detail in section
II.A.2. of this final rule with comment period, we make available the
public use files of claims, including, for CY 2008 and later,
supplemental line item cost data for every HCPCS code under the OPPS,
and a detailed narrative description of our data process for the annual
OPPS/ASC proposed and final rules that the public can use to perform
any desired analyses. Therefore, stakeholders are able to examine and
analyze these data to develop specific information to assess the impact
and effect of packaging for the services of interest to them. This
information is available to support public requests for changes to
payments under the OPPS, whether with regard to separate payment for a
packaged service or other issues. We understand that the OPPS is a
complex payment system and that it may be difficult to determine the
quantitative amount of packaged cost included in the cost for every
independent service. However, stakeholders routinely provide us with
meaningful analyses at a very detailed and service-specific level based
on the claims data we make available. We routinely receive complex and
detailed public comments, including extensive code-specific data
analysis on packaged and separately paid codes, using the data from
current and prior proposed and final rules.
Furthermore, we are not required, nor do we intend, to make annual
reports to the Panel regarding services that are subject to CMS'
packaging policies. We note that the Panel did not recommend at either
the February 2012 meeting or the August 2012 meeting that CMS present
annual reports on services subject to CMS' packaging services.
Comment: Commenters stated that CMS assumes that its packaging
policies will allow it to continue to collect the data it needs to set
appropriate, stable payment rates in the future. The commenters stated
that CMS' past experience with packaging payment for ancillary items
indicates that hospitals do not submit codes for services that do not
directly affect calculations of future payment rates for that Medicare
Severity-Diagnosis Related Group (MS-DRG). The commenters further
stated that, under the IPPS, hospitals report only the data required to
assign a case to the highest paying appropriate MS-DRG, even though
other data might affect payment in the long term. The commenters stated
that they saw no reason to believe that the current approach would have
a different outcome unless CMS gives clear instruction to continue
coding for all items and services provided and provides some incentive
to do so. The commenters asked that CMS require complete and correct
coding for packaged services.
Response: We do not believe that there has been or will be a
significant change in what hospitals report and charge for the
outpatient service they furnish to Medicare beneficiaries and other
patients as a result of our current packaging methodology. Medicare
cost reporting standards specify that hospitals must impose the same
charges for Medicare patients as for other patients. We are often told
by hospitals that many private payers pay based on a percentage of
charges and that, in accordance with Medicare cost reporting rules and
generally accepted accounting principles, hospital chargemasters do not
differentiate between the charges to Medicare patients and other
patients. Therefore, we have no reason to believe that hospitals will
stop reporting HCPCS codes and charges for packaged services they
provide to Medicare beneficiaries. As we stated in the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68575), we strongly encourage
hospitals to report a charge for each packaged service they furnish,
either by billing the packaged HCPCS code and a charge for that service
if separate reporting is consistent with CPT and CMS instructions, by
increasing the charge
[[Page 68276]]
for the separately paid associated service to include the charge for
the packaged service, or by reporting the charge for the packaged
service with an appropriate revenue code but without a HCPCS code. Any
of these means of charging for the packaged service will result in the
cost of the packaged service being incorporated into the cost we
estimate for the separately paid service. If a HCPCS code is not
reported when a packaged service is provided, we acknowledge that it
can be challenging to specifically track the utilization patterns and
resource cost of the packaged service itself. However, we have no
reason to believe that hospitals have not considered the cost of the
packaged service in reporting charges for the independent, separately
paid service. We expect that hospitals, as other prudent businesses,
have a quality review process that ensures that they accurately and
completely report the services they furnish, with appropriate charges
for that service to Medicare and all other payers. We encourage
hospitals to report on their claim for payment all HCPCS codes that
describe packaged service that were furnished, unless the CPT Editorial
Panel or CMS provides other guidance. To the extent that hospitals
include separate charges for packaged services on their claims, the
estimated costs of those packaged services are then added to the costs
of separately paid procedures on the same claims and used in
establishing payment rates for the separately paid services. It is
impossible to know with certainty whether hospitals are failing to
report HCPCS codes and charges for service for which the payment is
packaged into payment for the independent service with which the
packaged service is furnished. Moreover, if a hospital fails to report
the HCPCS codes and charges for packaged services, the reason may be
that the hospital has chosen to package the charge for the ancillary
and dependent service into the charge for the service with which it is
furnished. Although we prefer that hospitals report HCPCS codes and
charges for all service they furnish, if the hospital's charge for the
independent services also reflects the charge for all ancillary and
supportive service it typically provides, the absence of HCPCS codes
and separate charges would not result in inappropriately low cost for
the independent service, although CMS would not know which specific
ancillary and supportive services were being furnished. If a hospital
is no longer providing a service, there may be many reasons that a
hospital chooses not to provide a particular service or chooses to
cease providing a particular service, including, but not limited to,
because the hospital has determined that it is no longer cost effective
for the hospital to furnish the service and that there may be other
hospitals in the community that can furnish the service more
efficiently.
Comment: One commenter asked that CMS reinstate separate payment
for radiation oncology guidance procedures because these services are
vital to the safe provision of radiation therapy and unconditionally
packaging payment for them may discourage hospitals from providing
them.
Response: As we stated in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74188), we recognize that radiation oncology
guidance services, like most packaged services, are important to
providing safe and high quality care to patients. However, we continue
to believe that hospitals will invest in services that represent
genuinely increased value to patient care. We will continue to pay
separately for innovative technologies if a device meets the conditions
for separate payment as a pass-through device or if a new procedure
meets the criteria for payment as a new technology APC.
Comment: One commenter expressed concern over a statement made in
the proposed rule that indicated that CMS might propose to bundle
payment for [services] that [it] now refers to as ``independent
[services'']. The commenter stated that CMS did not provide any
statutory authority that would allow it to move away from a fundamental
OPPS policy, that only ``dependent services'' are potentially
considered as part of a bundled reimbursement methodology. The
commenter further stated that packaging payment for multiple services
that are not interrelated presents no efficiency or resource management
incentives, because, by definition, these services are not related,
meaning there are no efficiencies to be gained and no overlap in
resources expended.
Response: In the CY 2013 OPPS/ASC proposed rule (77 FR 45089), we
noted that we use the term ``independent service'' to refer to the
HCPCS codes that represent the primary therapeutic or diagnostic
modality into which we package payment for the dependent service. We
also noted that, in future years, as we consider the development of
larger payment groups that more broadly reflect services provided in an
encounter or episode of care, it is possible that we might propose to
bundle payment for a service that we now refer to as ``independent.''
We disagree with the commenter that we do not have the statutory
authority to consider larger payment bundles that more broadly reflect
services provided in an encounter or episode of care. Our statutory
authority is defined in section 1833(t)(2)(B) of the Act, which allows
the OPPS to establish groups of covered HOPD services, namely APC
groups, and use them as the basic unit of payment.
Furthermore, for CY 2008, we expanded packaging to services that
were once considered independent services and items, such as nonpass-
through contrast agents and observation services. We now consider these
services to be ancillary and supportive to a primary diagnostic or
therapeutic modality and have assigned these services an
unconditionally packaged status indicator of ``N.'' It follows then
that items or services that are currently considered to be
``independent'' services within this final rule with comment period may
be packaged where appropriate in future years, after taking into
consideration the clinical nature of the item or service and then
determining whether or not that item or service is considered ancillary
and supportive to a primary diagnostic or therapeutic modality.
We note that we did not make any new proposals to develop
additional payment bundles for CY 2013, but that we will likely do so
in future rulemaking. For CY 2013, we proposed to continue to package
the payment for items and services in seven categories with the primary
diagnostic or therapeutic modality to which we believe that these items
and services are typically ancillary and supportive. Because the
commenter does not question the appropriateness of these seven
categories of packaged payment given in the proposed rule nor does the
commenter question the appropriateness of a specific APC assignment for
a packaged HCPCS or CPT code, we cannot fully address the commenter's
concerns about bundling multiple services that are not interrelated and
that may or may not present efficiency or resource management
incentives. We continue to believe that the seven categories of
packaged services and items are appropriate to encourage hospital
efficiency, flexibility, and ultimately cost containment.
Comment: One commenter requested that CMS change the status
indicator for HCPCS code L8604 (Injectable bulking agent, dextranomer/
hyaluronic acid copolymer implant, urinary tract, 1 ml, includes
shipping and necessary
[[Page 68277]]
supplies) from ``N'' to ``A.'' The commenter argued that this would
allow HCPCS code L8604 to be paid under a different fee schedule and
would allow for access to the product SOLESTA[supreg] in the HOPD. The
commenter also asked that CMS cover and pay for SOLESTA[supreg] in the
same manner as other hyaluronic acid products and assign
SOLESTA[supreg] a separate and unique HCPCS code.
Response: HCPCS code L8604 describes several products that are
implantable prosthetic devices. According to 42 CFR 419.2(b)(11),
implantable prosthetic devices are packaged under the OPPS. Therefore,
status indicator ``N'' is the correct status indicator for HCPCS code
L8604. We also note that any coverage, reclassification, or HCPCS code
change requests for SOLESTA[supreg] are outside the scope of this final
rule with comment period. Such issues are addressed by processes
outside the OPPS/ASC rule by either CMS' HCPCS Workgroup or CMS'
Coverage and Analysis Group.
Comment: One commenter requested that CMS assign HCPCS code J7665
(Mannitol, administered through an inhaler, 5 mg) to a status indicator
of ``K'' for CY 2013. The commenter stated that the product that is
described by HCPCS code J7665 is a drug indicated for the assessment of
bronchial hyperresponsiveness in individuals at least six years of age
without clinically apparent asthma and that, consistent with its FDA
labeling, the product that is described by HCPCS code J7665 can only be
used in an institutional setting or a physician's office. The commenter
argued that HCPCS code J7665 was incorrectly assigned a status
indicator of ``N'' because this product is approved as a drug through
the NDA process and should be paid under the OPPS as a separately paid
drug as opposed to a supply under the OPPS.
Response: We agree with the commenter that HCPCS code J7665 can be
administered in the HOPD. However, we do not believe that the product
described by HCPCS code J7665 is a separately payable drug as we have
described here within this final rule with comment period, and is
instead a supply with costs included in the payment under the OPPS as
described in 42 CFR 419.2(b). Mannitol (HCPCS code J7665), when
administered through an inhaler, is always used as a supply in
bronchial challenge testing. Therefore, for CY 2013, we are assigning a
status indicator of ``N'' to HCPCS code J7665.
After consideration of the public comments we received, for CY
2013, we are finalizing our proposed policy to continue to package
payment for the services for which we proposed unconditional or
conditional packaged payment in the proposed rule for the reasons set
forth above.
f. Packaging of Drugs, Biologicals, and Radiopharmaceuticals
(1) Existing Packaging Policies
In the OPPS, we currently package five categories of drugs,
biologicals, and radiopharmaceuticals (unless temporary pass-through
status applies): (1) Those with per day costs at or below the packaging
threshold; (2) diagnostic radiopharmaceuticals; (3) contrast agents;
(4) anesthesia drugs; and (5) drugs treated as surgical supplies.
Anesthesia drugs are discussed further in section II.A.3.c.(2) of this
final rule with comment period. For detailed discussions of the
established packaging policies for diagnostic radiopharmaceuticals and
contrast agents, we refer readers to the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66765 through 66768). For further details on
drugs treated as surgical supplies, we refer readers to the CY 2003
OPPS final rule (67 FR 66767) and Chapter 15, Section 50.2 of the
Medicare Benefit Policy Manual.
(2) Clarification of Packaging Policy for Anesthesia Drugs
It has been longstanding OPPS policy to package ``anesthesia'' and
``supplies and equipment for administering and monitoring anesthesia or
sedation,'' as described in 42 CFR 419.2(b)(4) and (b)(5). As described
above, items and services paid under the OPPS that are typically
ancillary and supportive to a primary diagnostic or therapeutic
modality and, in those cases, are considered dependent items and
services are packaged into the payment of their accompanying
independent primary service. In accordance with our current policy on
packaging items and services, drugs that are used to produce anesthesia
in all forms are ancillary and supportive to a primary diagnostic or
therapeutic modality, and are included in our definition of
``anesthesia'' as described in Sec. 419.2(b)(4) and (b)(5). However,
we recognize that some anesthesia drugs may qualify for transitional
pass-through status under section 1833(t)(6) of the Act. Therefore, in
the CY 2013 OPPS/ASC proposed rule (77 FR45100), we proposed to clarify
that our general policy is to package drugs used to produce anesthesia,
and that those anesthesia drugs with pass-through status will be
packaged upon the expiration of pass-through status. We invited public
comment on our clarification of the existing packaging policies for
anesthesia drugs under Sec. 419.2(b)(4) and (b)(5).
Comment: Commenters objected to the proposed clarification of the
OPPS policy on anesthesia and all future policies that expand the
packaging of drugs, through the increase of the drug packaging
threshold or otherwise. The commenters expressed their concern over the
increase in packaging for drugs in general and urged CMS not to
finalize this policy. The commenters also stated their concern that the
CMS drug packaging polices used in the HOPD could encourage hospitals
to under utilize critically important drugs and ultimately compromise
beneficiary's access to care and undercut CMS' work to improve the
quality of care. The commenters urged CMS not to finalize this
proposal, to conduct a careful review to assess the effect of packaging
on quality of care, and to forego any new packaging policies as a
whole.
One commenter expressed support for the clarification of this
policy. The commenter further encouraged CMS to continue to monitor
packaged drugs and biologicals to ensure they are appropriately paid.
Response: For the CY 2013 OPPS/ASC proposed rule (77 FR 45100), we
proposed to clarify the existing policies related to nonpass-through
and pass-through anesthesia drugs. It has been our longstanding policy
to package anesthesia drugs, which are drugs that are used to produce
anesthesia in all forms and are ancillary and supportive to a primary
diagnostic or therapeutic modality, that are not on pass-through status
as included costs under the OPPS, as described in 42 CFR 419.2(b)(4)
and (b)(5). However, we also clarified in the proposed rule that
anesthesia drugs are eligible for transitional pass-through status as a
drug, as provided in section 1833(t)(6) of the Act. Therefore, we noted
that we were not finalizing a new policy to package nonpass-through
anesthesia drugs but were clarifying in our preamble language our
currently existing policies.
In addition, as we stated above, we continue to believe that
packaging payment for items and services that are ancillary to and
dependent on the major procedure for which a payment rate is
established is a fundamental concept of the OPPS. We address additional
comments on packaging for drugs, biologicals, diagnostic
radiopharmaceuticals, and contrast agents below in section II.A.3.f.
and section V.A. of this final rule with comment period.
[[Page 68278]]
After consideration of the public comments we received, we are
finalizing this proposed clarification for CY 2013. Anesthesia drugs
that are used to produce anesthesia in all forms are ancillary and
supportive to a primary diagnostic or therapeutic modality under 42 CFR
419.2(b)(4) and (b)(5). Therefore, nonpass-through anesthesia drugs are
packaged under the OPPS. New anesthesia drugs that were not being paid
for as an HOPD service as of December 31, 1996, and whose cost is ``not
insignificant'' in relation to the OPPS payment for the procedures or
services associated with the new anesthesia drug are eligible for
transitional pass-through status as a drug or biological, as described
in section 1833(t)(6) of the Act. We discuss OPPS transitional pass-
through payment for additional costs of drugs, biologicals, and
radiopharmaceuticals in section V.A. of this final rule with comment
period.
g. Packaging of Payment for Diagnostic Radiopharmaceuticals, Contrast
Agents, and Implantable Biologicals (``Policy-Packaged'' Drugs and
Devices)
Prior to CY 2008, the methodology of calculating a product's
estimated per day cost and comparing it to the annual OPPS drug
packaging threshold was used to determine the packaging status of
drugs, biologicals, and radiopharmaceuticals under the OPPS (except for
the CYs 2005 through 2009 exemption for 5-HT3 antiemetics). However, as
established in the CY 2008 OPPS/ASC final rule with comment period (72
FR 66766 through 66768), we began packaging payment for all diagnostic
radiopharmaceuticals and contrast agents into the payment for the
associated procedure, regardless of their per day costs. In addition,
in CY 2009, we adopted a policy that packaged the payment for nonpass-
through implantable biologicals into payment for the associated
surgical procedure on the claim, regardless of their per day cost (73
FR 68633 through 68636). We refer to diagnostic radiopharmaceuticals
and contrast agents collectively as ``policy-packaged'' drugs. We refer
to implantable biologicals as ``devices'' because, in CY 2010, we
finalized a policy to treat implantable biologicals as devices for OPPS
payment purposes (74 FR 60471 through 60477).
As set forth at Sec. 419.2(b), as a prospective payment system,
the OPPS establishes a national payment rate, standardized for
geographical wage differences, that includes operating and capital-
related costs that are directly related and integral to performing a
procedure or furnishing a service on an outpatient basis, and in
general, these costs include, but are not limited to, implantable
prosthetics, implantable durable medical equipment, and medical and
surgical supplies. Packaging costs into a single aggregate payment for
a service, encounter, or episode-of-care is a fundamental principle
that distinguishes a prospective payment system from a fee schedule. In
general, packaging the costs of items and services into the payment for
the primary procedure or service with which they are associated
encourages hospital efficiency and also enables hospitals to manage
their resources with maximum flexibility.
Prior to CY 2008, we noted that the proportion of drugs,
biologicals, and radiopharmaceuticals that were separately paid under
the OPPS had increased in recent years, a pattern that we also observed
for procedural services under the OPPS. Our final CY 2008 policy that
packaged payment for all nonpass-through diagnostic
radiopharmaceuticals and contrast agents, regardless of their per day
costs, contributed significantly to expanding the size of the OPPS
payment bundles and is consistent with the principles of a prospective
payment system.
As discussed in more detail in the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68645 through 68649), we presented several
reasons supporting our initial policy to package payment of diagnostic
radiopharmaceuticals and contrast agents into their associated
procedures on a claim. Specifically, we stated that we believed
packaging was appropriate because: (1) The statutorily required OPPS
drug packaging threshold had expired; (2) diagnostic
radiopharmaceuticals and contrast agents function effectively as
supplies that enable the provision of an independent service, rather
than serving themselves as a therapeutic modality; and (3) section
1833(t)(14)(A)(iii) of the Act required that payment for specified
covered outpatient drugs (SCODs) be set prospectively based on a
measure of average hospital acquisition cost (76 FR 74307).
Therefore, in the CY 2013 OPPS/ASC proposed rule (77 FR 45100), we
stated that we believe it is appropriate to continue to treat
diagnostic radiopharmaceuticals and contrast agents differently from
specified covered outpatient drugs (SCODs) for CY 2013. Therefore, we
proposed to continue packaging payment for all contrast agents and
diagnostic radiopharmaceuticals, collectively referred to as ``policy-
packaged'' drugs, regardless of their per day costs, for CY 2013. We
also proposed to continue to package the payment for diagnostic
radiopharmaceuticals into the payment for the associated nuclear
medicine procedure and to package the payment for contrast agents into
the payment for the associated echocardiography imaging procedure,
regardless of whether the agent met the OPPS drug packaging threshold.
We refer readers to the CY 2010 OPPS/ASC final rule with comment period
for a detailed discussion of nuclear medicine and echocardiography
services (74 FR 35269 through 35277).
Comment: Commenters objected to CMS' proposal to package payment of
all nonpass-through diagnostic radiopharmaceuticals and contrast agents
in CY 2013. A number of commenters stated that diagnostic
radiopharmaceuticals and contrast agents with per day costs over the
proposed OPPS drug packaging threshold are defined as SCODs and,
therefore, should be assigned separate APC payments. In particular, the
commenters questioned CMS' authority to classify groups of drugs, such
as diagnostic radiopharmaceuticals and contrast agents, and implement
packaging and payment policies that do not reflect their status as
SCODs. Several commenters disagreed with CMS' labeling of
radiopharmaceuticals as supplies and stated instead that they should be
treated as other SCODs. The commenters recommended that diagnostic
radiopharmaceuticals should be subject to the same per day cost drug
packaging threshold that applies to other drugs, in order to determine
whether their payment would be packaged or made separately.
One commenter supported CMS' continued packaging policy for
diagnostic radiopharmaceuticals and contrast agents that do not have
pass-through status. The commenter noted that diagnostic
radiopharmaceuticals are supplies that are necessary to the provision
of the service in which they are used and, like other supplies, payment
for them should be part of the payment for the service.
Response: As discussed in the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66766), the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68645), the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60497), the CY 2011 OPPS/ASC final rule with
comment period (75 FR 71949), and the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74307), we continue to believe that diagnostic
radiopharmaceuticals and contrast agents are different from other drugs
[[Page 68279]]
and biologicals for several reasons. We note that the statutorily
required OPPS drug packaging threshold, as described in section
1833(t)(16)(B) of the Act, has expired, and we continue to believe that
diagnostic radiopharmaceuticals and contrast agents function
effectively as supplies that enable the provision of an independent
service and are always ancillary and supportive to an independent
service, rather than themselves serving as the therapeutic modality. We
packaged their payment in CYs 2008, 2009, 2010, 2011, and 2012 as
ancillary and supportive services in order to provide incentives for
greater efficiency and to provide hospitals with additional flexibility
in managing their resources. In order for payment to be packaged, it is
not necessary that all products be interchangeable in every case, and
we recognized that, in some cases, hospitals may utilize higher cost
products and, in some cases, lower cost products, taking into
consideration the clinical needs of the patient and the efficient use
of hospital resources. While we recognize this variability from case to
case, on average under a prospective payment system, we expect payment
to cover the costs for the services furnished. In the past, we have
classified different groups of drugs for specific payment purposes, as
evidenced by our CY 2005 through CY 2009 policy regarding 5-HT3 anti-
emetics and their exemption from the drug packaging threshold. We note
that we treat diagnostic radiopharmaceuticals and contrast agents as
``policy-packaged'' drugs because our policy is to package payment for
all of the products in this category.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68634), we also began packaging the payment for all nonpass-through
implantable biologicals into payment for the associated surgical
procedure because we consider these products to always be ancillary and
supportive to an independent service, similar to implantable non-
biological devices that are always packaged. Therefore, we currently
package payment of nonpass-through implantable biologicals, also known
as devices that are surgically inserted or implanted (through a
surgical incision or a natural orifice) into the body. As we stated in
the CY 2013 OPPS/ASC proposed (77 FR 45101), we continue to believe
that payment should be packaged for nonpass-through implantable
biologicals for CY 2013.
We are continuing our CY 2009 policy for CY 2013 as discussed
below, which packages payment for all nonpass-through diagnostic
radiopharmaceuticals, contrast agents, and implantable biologicals into
the payment for their associated procedures. We also continue to
believe that the line-item estimated cost for nonpass-through
diagnostic radiopharmaceuticals, contrast agents, or implantable
biologicals in our claims data is a reasonable approximation of average
acquisition and preparation and handling costs for nonpass-through
diagnostic radiopharmaceuticals, contrast agents, and implantable
biologicals, respectively. As we discussed in the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68645), we believe that hospitals
have adapted to the CY 2006 coding changes for nonpass-through
diagnostic radiopharmaceuticals and responded to our instructions to
include charges for diagnostic radiopharmaceutical handling in their
charges for the diagnostic radiopharmaceutical products. Further,
because the standard OPPS packaging methodology packages the total
estimated cost of each nonpass-through diagnostic radiopharmaceutical,
contrast agent, or nonimplantable biological on each claim (including
the full range of costs observed on the claims) with the cost of
associated procedures for ratesetting, this packaging approach is
consistent with considering the average cost for nonpass-through
diagnostic radiopharmaceuticals, contrast agents, or implantable
biologicals, rather than the cost. In addition, as we noted in the CY
2009 OPPS/ASC final rule with comment period (73 FR 68646), these
drugs, biologicals, or diagnostic radiopharmaceuticals for which we
have not established a separate APC and, therefore, for which payment
would be packaged rather than separately provided under the OPPS are
not considered to be SCODs. Similarly, drugs and biologicals with per
day costs of less than the drug packaging threshold for CY 2013, which
is discussed in section V.B. of this final rule with comment period,
that are packaged and for which a separate APC has not been established
also are not SCODs. This reading is consistent with our final packaging
payment policy, as discussed in this section, whereby we package
payment for nonpass-through diagnostic radiopharmaceuticals, contrast
agents, and implantable biologicals and provide payment for these
products through payment for their associated procedures.
Comment: Several commenters disagreed with the proposal to
distinguish between diagnostic and therapeutic radiopharmaceuticals for
payment purposes under the OPPS. Some commenters noted that CMS'
identification of HCPCS code A0544 (Iodine I-131 tositumomab,
diagnostic, per study dose) as a diagnostic radiopharmaceutical is
inappropriate because this radiopharmaceutical functions as a
dosimetric radiopharmaceutical and not as a diagnostic
radiopharmaceutical. A few commenters explained that this particular
radiopharmaceutical product is used as part of a therapeutic regimen
and, therefore, should be considered therapeutic for OPPS payment
purposes. Furthermore, many commenters urged CMS to classify dosimetric
doses used in radiopharmaceutical procedures as therapeutic in nature,
and allow for separate payment for that dosimetric dose.
Response: As discussed above and in the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66641), the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68645), the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60498), the CY 2011 OPPS/ASC final rule with
comment period (75 FR 71949), and the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74308), we classified each radiopharmaceutical
into one of the two groups according to whether its long descriptor
contained the term ``diagnostic'' or ``therapeutic.'' HCPCS code A9544
contains the term ``diagnostic'' in its long code descriptor.
Therefore, according to our established methodology, we continued to
classify it as diagnostic for the purposes of CY 2012 OPPS payment.
While we understand that this item is provided in conjunction with
additional supplies, imaging tests, and therapeutic
radiopharmaceuticals for patients already diagnosed with cancer, we
continue to believe that the purpose of administering the product
described by HCPCS code A9544 is diagnostic in nature. As we first
stated in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66641), we continue to believe that the product described by HCPSC code
A9544 is a diagnostic radiopharmaceutical. While it is not used to
necessarily diagnose a general disease state, we understand that it is
used to determine whether future therapeutic services would be
beneficial to the patient and to determine how to proceed with therapy.
We note that this is not different than the use of a laboratory test to
guide therapy; the fact that the diagnostic test, a service which
provides information, is used to guide therapy does not make it a
therapeutic
[[Page 68280]]
service, on which its intent is to improve a patient's clinical
condition. While a group of associated services may be considered a
therapeutic regimen by some commenters, HCPCS code A9544 is provided in
conjunction with a series of nuclear medicine imaging scans. Many
nuclear medicine studies using diagnostic radiopharmaceuticals are
provided to patients who already have an established diagnosis. We
continue to consider HCPCS code A9544 to be diagnostic because this
item is provided for the purpose of conducting a diagnostic imaging
procedure and is used to identify the proposed dose of the therapeutic
agent to be provided at a later time.
Comment: Commenters recommended using the ASP methodology and the
proposed statutory default rate of ASP+6 percent to make payment for
nonpass-through diagnostic radiopharmaceuticals and contrast agents.
The commenters noted that it would be inconsistent for CMS to treat
diagnostic radiopharmaceuticals and contrast agents as ``drugs'' for
pass-through payment purposes and provide payment for diagnostic
radiopharmaceuticals and contrast agents that have pass-through status
based on the ASP methodology, and, then, after the diagnostic
radiopharmaceutical's or contrast agent's pass-through payment status
expires, package the costs included in historical hospital claims data,
rather than use the ASP methodology to pay for the product and treat
the drug as a supply. A few commenters suggested that diagnostic
radiopharmaceuticals could be paid separately as therapeutic
radiopharmaceuticals are paid, which would allow manufacturer to
voluntarily submit ASP data, and then default to the mean unit cost
when ASP data are unavailable. Some commenters recommended that CMS use
ASP data as a benchmark for determining costs for diagnostic
radiopharmaceuticals that are packaged.
One commenter stated that payment for diagnostic
radiopharmaceuticals should not be paid at ASP+6 percent for the
reasons commenters provided when CMS proposed to make payment at ASP+6
percent in prior years. Specifically, the commenter noted that the ASP
statute excludes reporting of the ASP for diagnostic
radiopharmaceuticals and, therefore, such reporting would need to be
voluntary. However, in terms of voluntary reporting of diagnostic
radiopharmaceuticals, the commenter further noted that CMS could never
be confident that it would receive reports from all manufacturers of
any particular diagnostic radiopharmaceutical. Moreover, the commenter
stated, high volume diagnostic radiopharmaceuticals are furnished using
generators that hospitals use for up to 28 days to provide doses of
diagnostic radiopharmaceuticals as needed and therefore the
manufacturer, who would report the ASP under penalty of perjury, would
never be able to certify the actual number of doses furnished with
confidence. The commenter finally noted that packaging is consistent
with the general principles of a prospective payment system, one goal
of which is to encourage hospital cost containment.
Response: As we stated above, the statutorily required OPPS drug
packaging threshold has expired, and we continue to believe that
nonpass-through diagnostic radiopharmaceuticals and contrast agents are
always ancillary and supportive to an independent service, rather than
services themselves as the therapeutic modality. We disagree with
commenters who suggest that nonpass-through diagnostic
radiopharmaceuticals and contrast agents should be paid under the ASP
methodology, that nonpass-through diagnostic radiopharmaceuticals and
contrast agents should be paid as pass-through drugs and biologicals,
or that nonpass-through diagnostic radiopharmaceuticals should be paid
similarly to therapeutic radiopharmaceuticals. We continue to believe
that nonpass-through diagnostic radiopharmaceuticals, contrast agents,
and implantable biologicals function effectively as supplies that
enable the provision of an independent service. As we noted in the CY
2009 OPPS/ASC final rule with comment period (73 FR 68646) and restate
above, drugs, biologicals, or radiopharmaceuticals for which we have
not established a separate APC will receive packaged payment under the
OPPS, and are considered not to be SCODs. We continue to believe that
the line-item estimated cost for nonpass-through diagnostic
radiopharmaceuticals, contrast agents, and implantable biologicals in
our claims data is a reasonable approximation of average acquisition
and preparation and handling costs for diagnostic radiopharmaceuticals,
contrast agents, and implantable biologicals, respectively.
Further, as we have stated above, we believe that packaging costs
into a single aggregate payment for a service, encounter, or episode-
of-care is a fundamental principle that distinguishes a prospective
payment system from a fee schedule. Our policy of packaging payment for
nonpass-through diagnostic radiopharmaceuticals, contrast agents, and
implantable biologicals into the payment for the primary procedure or
service with which they are associated encourages hospital efficiencies
and also enables hospitals to manage their resources with maximum
flexibility. Paying separately for nonpass-through diagnostic
radiopharmaceuticals, contrast agents, and implantable biologicals,
when each of these items is ancillary or supportive to an independent
service, is contrary to this principle of a prospective payment system.
Finally, we do not agree with the commenter's assertion that
separate payment for diagnostic radiopharmaceuticals would result in
more accurate payment for these products. When CMS discussed possible
ASP-based payment for diagnostic radiopharmaceuticals in the CY 2006
OPPS final rule with comment period (70 FR 68653 through 68657),
numerous commenters advised CMS that diagnostic radiopharmaceuticals
are formulated, distributed, compounded, and administered in unique
distribution channels that preclude the determination of ASP relevant
to a diagnostic radiopharmaceutical HCPCS codes. Further, commenters
advised CMS that the manufacturer has no way to calculate the ASP of
the end product patient dose and, consequently, could not supply CMS
with accurate ASP data. In the intervening period between the CY 2006
final rule with comment period and the present, diagnostic
radiopharmaceutical use has become more widespread and its formulation
more complex. Moreover, we believe that the phenomena described by
commenters (including radiopharmaceutical manufacturers) in the comment
period preceding the CY 2006 OPPS final rule with comment period,
including the many preparatory and compounding steps between
manufacturer and the patient's bedside, remain an impediment to
manufacturers' calculations of accurate ASP and thus accurate payment
for these products. Therefore, we do not believe that diagnostic
radiopharmaceuticals (or contrast agents or implantable biologicals)
should be paid separately under the OPPS such that manufactures
voluntarily can submit ASP data and then default to mean unit cost when
ASP data are unavailable. We believe they are appropriately packaged
into a single
[[Page 68281]]
aggregate payment for the accompanying services.
Comment: Commenters recommended that CMS modify the way that it
applies the ``2 times'' rule for nuclear medicine APCs by including the
cost of the packaged diagnostic radiopharmaceutical drugs in its
analysis and not just the cost of services. The commenters argued that
this is mandated by the statute, which provides that an APC group
cannot be considered comparable with respect to the use of resources if
the highest cost for an item or service in the APC group is more than
two times greater than the lowest cost for an item or service within
the same APC group. Therefore, the commenters believed that it is
logical that as long as CMS views the packaged nuclear medicine service
and the radiopharmaceutical as one unit for APC payment purposes, it
should consider both components together in applying the 2 times rule
and analysis to APC payment.
Response: While the language in section 1833(t)(2) of the Act
regarding the 2 times rule describes consideration of both items and
services for purposes of identifying exceptions to the rule, it does so
within the context of services that belong to an APC group.
Unconditionally packaged items and services, being associated with the
particular item or service being modeled for separate payment, would
not individually belong to any APC group. However, these
unconditionally packaged costs would be incorporated into the system
through the separately paid items or services with which they appear on
the claim, and would thus be factored into the ultimate consideration
of the 2 times rule. Therefore, consideration of items and services
within each APC only applies to the separately paid HCPCS and CPT codes
assigned to each APC and would thus not include any discrete
calculation for packaged costs with regards to the two times rule.
Comment: One commenter recommended that CMS establish a threshold
for radiopharmaceutical drugs that would trigger separate payment when
the cost of the radiopharmaceutical is greater than the total APC
payment or over another threshold value.
Response: Consistent with the CY 2013 OPPS/ASC proposed rule, for
this final rule with comment period, we continue to believe that
diagnostic radiopharmaceuticals are ancillary and supportive to the
nuclear medicine procedures in which they are used and that their costs
should be packaged into the primary procedures with which they are
associated. We do not believe it would be appropriate to set a cost
threshold for packaging diagnostic radiopharmaceuticals because,
regardless of their per day cost, they are always supportive of an
independent procedure that is the basis for administration of the
diagnostic radiopharmaceutical. We also do not believe that it is
appropriate to consider alternate packaging criteria for nonpass-
through diagnostic radiopharmaceuticals because we continue to believe
that, regardless of their per-day cost, these items are always
supportive of an independent procedure that is the basis for
administration of the diagnostic radiopharmaceutical. Therefore, our
policy of packaging costs for these products into an associated APC
continues to be the approach best suited for use in this prospective
payment system.
Further, we note that the OPPS, as a prospective payment system,
already includes the costs associated with diagnostic
radiopharmaceuticals into the APCs for which the product is ancillary
and supportive. We believe that the cost associated with a given
product at a given point in time is immaterial because the OPPS, as a
prospective payment system with payments based on average costs
associated with a covered procedure, already takes into account both
higher and lower input costs associated with that procedure. We also
note that the OPPS, like many of Medicare's prospective payment
systems, has polices in place to provide hospitals with additional
outlier payments for certain high-cost cases whose costs exceed certain
thresholds. This system of outliers already provides hospitals (or, in
the case of partial hospitalization services, community mental health
centers) with additional reimbursement to offset costs that are high
relative to the prospective payment amount, regardless of whether the
costs are associated with diagnostic radiopharmaceuticals or another
relatively high cost element in the patient's course of care.
Comment: One commenter requested that CMS present additional,
detailed information regarding how the agency ensures that the full
cost of diagnostic radiopharmaceuticals are captured in the associated
packaged APC procedural payments, including the validation methods used
by the agency.
Response: The data that CMS used to calculate, propose, and
finalize APC assignments and rates, including costs associated with
diagnostic radiopharmaceuticals, for the CY 2013 OPPS, are available
for purchase under a CMS data use agreement through the CMS Web site
at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatinetPPS/index.html. This Web site includes information
about purchasing the ``OPPS Limited Data Set,'' which now includes the
additional variable previously available only in the OPPS Identifiable
Data set, including ICD-9-CMS diagnosis codes and revenue code payment
amounts.
As we state above, we discuss in detail in section II.A.2. of this
final rule with comment period the availability to the public of the
use of files of claims, including, for CY 2008 and later, supplemental
line item cost data for every HCPCS code under the OPPS, and a detailed
narrative description of our data process for the annual OPPS/ASC
proposed and final rules that the public can use to perform any desired
analyses.
We continue to believe that the cost of a diagnostic
radiopharmaceutical is captured into the associated packaged APC
procedural payment. We see no need at this time to provide further data
analyses.
For CY 2013, we proposed to make an additional payment of $10 for
diagnostic radiopharmaceuticals that utilize the Tc-99m radioisotope
produced by non-HEU methods (77 FR 45121). We proposed to base this
payment on the best available estimations of the marginal costs
associated with non-HEU radioisotope production, pursuant to our
authority described in section 1833(t)(2)(E) of the Act which allows us
to establish ``other adjustments as determined to be necessary to
ensure equitable payments'' under the OPPS. We described this policy in
further detail in section III.C.3. of the proposed rule.
We received numerous comments on this proposal, including comments
that suggested that separate payment for diagnostic
radiopharmaceuticals is the most effective way to encourage hospital
conversion from HEU to non-HEU sources that utilize Tc-99m. We have
addressed these comments on the proposed payment for non-HEU sources
that recommended separate payment for diagnostic radiopharmaceuticals
above and in section III.C.3. of this final rule with comment period.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68634), we began packaging the payment for all nonpass-through
implantable biologicals into payment for the associated surgical
procedure because we consider these products to always be ancillary and
supportive to independent services, similar to implantable
[[Page 68282]]
nonbiological devices that are always packaged. We continued to follow
this policy in CY 2012 (76 FR 74306 through 74310). Specifically, we
continue to package payment for nonpass-through implantable
biologicals, also known as devices that are surgically inserted or
implanted (through a surgical incision or a natural orifice) into the
body. In the CY 2013 OPPS/ASC proposed rule (77 FR45101), for CY 2013,
we proposed to continue to apply the policies finalized in CY 2012, to
package payment for nonpass-through implantable biologicals
(``devices'') that are surgically inserted or implanted (through a
surgical incision or a natural orifice) into the body.
Comment: One commenter requested that HCPCS code Q4130 (Strattice
tm, per square centimeter) be assigned status indicator ``K'' for CY
2013 because, the commenter argued, HCPCS code Q4130 is a skin
substitute graft for chronic wounds and a surgical biological implant
for breast reconstruction and hernia repair procedures. The commenter
stated that assigning HCPCS code Q4130 to a status indicator of ``K''
would signify its use as a biological skin substitute graft for which
separate payment is available.
The commenter further noted that Transmittal 2418 of the Medicare
Claims Processing Manual lists HCPCS code Q4130 in table 5 of the
transmittal, along with other biologicals with ``dual'' use.
Response: HCPCS code Q4130 was assigned a status indicator of ``N''
in the CY 2013 OPPS/ASC proposed rule, signifying that the product that
is represented by this code is an implantable biological device. We
continue to believe that the product described by HCPCS code Q4130 is
an implantable biological device, as evidenced by language within the
510(k) FDA clearance which lists the product described by HCPCS code
Q4130 as a surgical mesh intended for the reinforcement of soft tissue
repaired by sutures or suture anchors during tendon repair surgery
including reinforcement of rotator cuff, patella, Achilles, biceps,
quadriceps, or other tendons. Further indications of use include the
repair of body wall defects which require the use of reinforcing or
bridging material to obtain the desired surgical outcome. As we stated
above, the payment for nonpass-through implantable biologicals, or
implanted devices, is packaged into the payment for the primary
procedure. Therefore, we are continuing to assign a status indicator of
``N'' to HCPCS code Q4130 for CY 2013. Additionally, we are correcting
the table within Transmittal 2418 which contains a list of skin
substitutes only.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period expressed concern that Medicare contractors
had been inadvertently making separate payment for nonpass-through
biological implants as they process OPPS claims for breast
reconstruction and hernia repair procedures. The commenter stated that
these procedure claims included claims for biological implants,
including HCPCS codes Q4100 through Q4130. The commenter noted that
HCPCS code Q4116 (Alloderm, per square centimeter) in particular was
paid separately on several occasions. Therefore, the commenter
recommended that CMS take several steps to prevent further billing
errors with respect to the OPPS payment policy for implantable
biologicals.
Response: For the April 2012 quarterly update, we installed logic
changes in the I/OCE to allow for separate payment for separately
payable skin substitute HCPCS codes that are coded with skin substitute
procedure CPT codes only. We reminded hospitals that HCPCS codes
describing skin substitutes should only be separately reported when
used with one of the CPT codes describing the application of a skin
substitute (CPT codes 15271 through 15278). Therefore, we have
previously addressed the commenters' concerns.
Under the OPPS, HCPCS codes that describe skin substitute products,
with a separately payable status indicator of ``K'' or ``G'' that are
billed with a skin substitute application procedure, will receive
separate payment for both the skin substitute product and the
procedure. Payment for skin substitute HCPCS codes that are billed with
other procedures will be packaged into the payment for the
corresponding procedure.
After consideration of the public comments we received, we are
finalizing our proposals, without modification, to continue to package
payment for all nonpass-through diagnostic radiopharmaceuticals and
contrast agents, and implantable biologicals that are surgically
inserted or implanted into the body through a surgical incision or a
natural orifice, regardless of their per day costs. Given the inherent
function of diagnostic radiopharmaceuticals and contrast agents as
ancillary and supportive to the performance of an independent procedure
and the similar functions of implantable biologicals and nonbiological
devices as integral to and supportive of the separately paid surgical
procedures in which either may be used, we continue to view the
packaging of payment for diagnostic radiopharmaceuticals, contrast
agents, and implantable biologicals as a logical expansion of packaging
payment for drugs and biologicals. In addition, as we initially
established in the CY 2008 OPPS/ASC final rule with comment period (72
FR 66768), we will continue to identify diagnostic radiopharmaceuticals
specifically as those Level II HCPCS codes that include the term
``diagnostic'' alone with a radiopharmaceutical in their long code
descriptors, and therapeutic radiopharmaceuticals as those Level II
HCPCS codes that include the term ``therapeutic'' along with a
radiopharmaceuticals in their long code descriptors. We believe that
the current descriptors accurately discriminate between those
radiopharmaceuticals that are used to gather information and those
which are intended to improve the patient's medical condition.
In addition, any new biological lacking pass-through status that is
surgically inserted or implanted through a surgical incision or natural
orifice will be packaged in CY 2013.
We refer reader to section III.D.1.f. of this final rule with
comment period for a discussion of comments related to echocardiography
services furnished with and without contrast. For more information on
how we set CY 2013 payment rates for nuclear medicine procedures in
which diagnostic radiopharmaceuticals are used an echocardiography
services provided with and without contrast agents, we refer readers to
the CY 2010 OPPS/ASC final rule with comment period for a detailed
discussion of nuclear medicine and echocardiography services (74 FR
35269 through 35277).
h. Summary of Proposals
As we proposed, we are finalizing, for this final rule with comment
period, the HCPCS codes that we unconditionally packaged (for which we
continue to assign status indicator ``N''), or conditionally packaged
(for which we continue to assign status indicators ``Q1,'' ``Q2,'' or
``Q3''), and those codes are displayed in Addendum B of this final rule
with comment period (which is available via the Internet on the CMS Web
site). The supporting documents for this CY 2013 OPPS/ASC final rule
with comment period, including, but not limited to, Addendum B, are
available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. To
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view the status indicators by HCPCS code in Addendum B, select ``CMS
1589-FC'' and then select the folder labeled ``2013 OPPS Final Rule
Addenda'' from the list of supporting files. Open the zipped file and
select Addendum B, which is available as both an Excel file and a text
file.
4. Calculation of OPPS Scaled Payment Weights
In the CY 2013 OPPS/ASC proposed rule (77 FR 45101), we proposed
for CY 2013 to calculate the relative payment weights for each APC for
CY 2013 shown in Addenda A and B to the proposed rule (which were
available via the Internet on the CMS Web site) using the APC costs
discussed in sections II.A.1. and II.A.2. of the proposed rule. In
years prior to CY 2007, we standardized all the relative payment
weights to APC 0601 (Mid-Level Clinic Visit) because mid-level clinic
visits were among the most frequently performed services in the
hospital outpatient setting. We assigned APC 0601 a relative payment
weight of 1.00 and divided the median cost for each APC by the median
cost for APC 0601 to derive the relative payment weight for each APC.
Beginning with the CY 2007 OPPS (71 FR 67990), we standardized all
of the relative payment weights for APC 0606 (Level 3 Clinic Visits)
because we deleted APC 0601 as part of the reconfiguration of the
clinic visit APCs. We selected APC 0606 as the base because APC 0606
was the mid-level clinic visit APC (that is, Level 3 of five levels).
For CY 2013, we proposed to base the relative payment weights on which
OPPS payments will be made by using geometric mean costs, as described
in section II.A.2.f. of the proposed rule. However, in an effort to
maintain consistency in calculating unscaled weights that represent the
cost of some of the most frequently provided services, we proposed to
continue to use the cost of the mid-level clinic visit APC (APC 0606)
in calculating unscaled weights. Following our general methodology for
establishing relative payment weights derived from APC costs, but using
the proposed CY 2013 geometric mean cost for APC 0606, for CY 2013, we
proposed to assign APC 0606 a relative payment weight of 1.00 and to
divide the geometric mean cost of each APC by the proposed geometric
mean cost for APC 0606 to derive the proposed unscaled relative payment
weight for each APC. We stated that the choice of the APC on which to
base the proposed relative payment weights for all other APCs does not
affect the payments made under the OPPS because we scale the weights
for budget neutrality.
Section 1833(t)(9)(B) of the Act requires that APC reclassification
and recalibration changes, wage index changes, and other adjustments be
made in a budget neutral manner. Budget neutrality ensures that the
estimated aggregate weight under the OPPS for CY 2013 is neither
greater than nor less than the estimated aggregate weight that would
have been made without the changes. To comply with this requirement
concerning the APC changes, we proposed to compare the estimated
aggregate weight using the CY 2012 scaled relative payment weights to
the estimated aggregate weight using the CY 2013 unscaled relative
payment weights. For CY 2012, we multiplied the CY 2012 scaled APC
relative weight applicable to a service paid under the OPPS by the
volume of that service from CY 2011 claims to calculate the total
weight for each service. We then added together the total weight for
each of these services in order to calculate an estimated aggregate
weight for the year. For CY 2013, as we proposed, we performed the same
process using the CY 2013 unscaled relative payment weights rather than
scaled relative payment weights. We then calculated the weight scaler
by dividing the CY 2012 estimated aggregate weight by the CY 2013
estimated aggregate weight. The service-mix is the same in the current
and prospective years because we use the same set of claims for service
volume in calculating the aggregate weight for each year. For a
detailed discussion of the weight scaler calculation, we refer readers
to the OPPS claims accounting document available on the CMS Web site
at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
As we proposed, in this final rule with comment period, we include
estimated payments to CMHCs in our comparison of estimated unscaled
weights in CY 2013 to estimated total weights in CY 2012 using CY 2011
claims data, holding all other components of the payment system
constant to isolate changes in total weight. Based on this comparison,
we adjusted the unscaled relative payment weights for purposes of
budget neutrality. The CY 2013 unscaled relative payment weights were
adjusted by multiplying them by a weight scaler of 1.3596 to ensure
that the CY 2013 relative payment weights are budget neutral.
Section 1833(t)(14) of the Act provides the payment rates for
certain SCODs. Section 1833(t)(14)(H) of the Act states that
``Additional expenditures resulting from this paragraph shall not be
taken into account in establishing the conversion factor, weighting,
and other adjustment factors for 2004 and 2005 under paragraph (9), but
shall be taken into account for subsequent years.'' Therefore, the cost
of those SCODs (as discussed in section V.B.3. of this final rule) was
included in the budget neutrality calculations for the CY 2013 OPPS.
We did not receive any public comments on the proposed methodology
for calculating scaled weights based on the geometric mean costs for
the CY 2013 OPPS. Therefore, for the reasons set forth in the proposed
rule (77 FR 45101), we are finalizing our proposed methodology without
modification, including updating of the budget neutrality scaler for
this final rule with comment period as we proposed. Under this
methodology, the final unscaled relative payment weights were adjusted
by a weight scaler of 1.3596 for this final rule with comment period.
The final scaled relative payment weights listed in Addenda A and B to
this final rule with comment period (which are available via the
Internet on the CMS Web site) incorporate the final recalibration
adjustments discussed in sections II.A.1. and II.A.2. of this final
rule with comment period.
We noted in the proposed rule that we were providing additional
information, in association with the proposed rule, so that the public
could provide meaningful comment on our proposed policy to base the CY
2013 OPPS relative payment weights on geometric mean costs. The scaled
relative payment weights listed in Addenda A and B to this final rule
with comment period (which are available via the Internet on the CMS
Web site) incorporate the recalibration adjustments discussed in
sections II.A.1. and II.A.2. of this final rule with comment period.
B. Conversion Factor Update
Section 1833(t)(3)(C)(ii) of the Act requires the Secretary to
update the conversion factor used to determine the payment rates under
the OPPS on an annual basis by applying the OPD fee schedule increase
factor. For purposes of section 1833(t)(3)(C)(iv) of the Act, subject
to sections 1833(t)(17) and 1833(t)(3)(F) of the Act, the OPD fee
schedule increase factor is equal to the hospital inpatient market
basket percentage increase applicable to hospital discharges under
section 1886(b)(3)(B)(iii) of the Act. In the FY 2013 IPPS/LTCH PPS
final rule (77 FR 53414), consistent with current law,
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based on IHS Global Insight, Inc.'s second quarter 2012 forecast of the
FY 2013 market basket increase, the FY 2013 IPPS market basket update
is 2.6 percent. However, sections 1833(t)(3)(F) and 1833(t)(3)(G)(ii)
of the Act, as added by section 3401(i) of Pub. L. 111-148 and as
amended by section 10319(g) of that law and further amended by section
1105(e) of Public Law 111-152, provide adjustments to the OPD fee
schedule increase factor for CY 2013.
Specifically, section 1833(t)(3)(F)(i) of the Act requires that,
for 2012 and subsequent years, the OPD fee schedule increase factor
under subparagraph (C)(iv) be reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment as
equal to the 10-year moving average of changes in annual economy-wide,
private nonfarm business multifactor productivity (MFP) (as projected
by the Secretary for the 10-year period ending with the applicable
fiscal year, year, cost reporting period, or other annual period) (the
``MFP adjustment''). In the FY 2012 IPPS/LTCH PPS final rule (76 FR
51689 through 51692), we finalized our methodology for calculating and
applying the MFP adjustment. In the FY 2013 IPPS/LTCH PPS proposed rule
(77 FR 27975 through 27976), we discussed the calculation of the
proposed MFP adjustment for FY 2013, which was 0.8 percentage point.
We proposed that if more recent data became subsequently available
after the publication of the proposed rule (for example, a more recent
estimate of the market basket increase and the MFP adjustment), we
would use such data, if appropriate, to determine the CY 2013 market
basket update and the MFP adjustment, components in calculating the OPD
fee schedule increase factor under sections 1833(t)(3)(C)(iv) and (F)
of the Act, in this CY 2013 OPPS/ASC final rule with comment period. In
the FY 2013 IPPS/LTCH PPS final rule (77 FR 53414), we discussed the
calculation of the final MFP adjustment for FY 2013, which is 0.7
percentage point.
In addition, section 1833(t)(3)(F)(ii) of the Act requires that for
each of year 2010 through 2019, the OPD fee schedule increase factor
under section 1833(t)(3)(C)(iv) of the Act be reduced by the adjustment
described in section 1833(t)(3)(G) of the Act. For CY 2013, section
1833(t)(3)(G)(ii) of the Act provides a 0.1 percentage point reduction
to the OPD fee schedule increase factor under section 1833(t)(3)(C)(iv)
of the Act. Therefore, in accordance with sections 1833(t)(3)(F)(ii)
and 1833(t)(3)(G)(ii) of the Act, in the CY 2013 OPPS/ASC proposed rule
(77 FR 45102), we proposed to apply a 0.1 percentage point reduction to
the OPD fee schedule increase factor for CY 2013.
We note that section 1833(t)(3)(F) of the Act provides that
application of this subparagraph may result in the OPD fee schedule
increase factor under section 1833(t)(3)(C)(iv) of the Act being less
than 0.0 for a year, and may result in payment rates under the OPPS for
a year being less than such payment rates for the preceding year. As
described in further detail below, using the final methodology and more
recent data would result in an OPD fee schedule increase factor of 1.8
percent for the CY 2013 OPPS (2.6 percent, which is the final estimate
of the hospital inpatient market basket percentage increase, less the
final 0.7 percentage point MFP adjustment, less the 0.1 percentage
point additional adjustment).
We note that hospitals that fail to meet the Hospital OQR Program
reporting requirements are subject to an additional reduction of 2.0
percentage points from the OPD fee schedule increase factor adjustment
to the conversion factor that would be used to calculate the OPPS
payment rates for their services, as required by section 1833(t)(17) of
the Act. As a result, using the final methodology and more recent data,
those hospitals failing to meet the Hospital OQR Program reporting
requirements will receive an OPD fee schedule increase factor of -0.2
(2.6 percent, which is the final estimate of the hospital inpatient
market basket percentage increase, less the final 0.7 percentage point
MFP adjustment, less the 0.1 percentage point additional adjustment,
less 2.0 percentage points for the Hospital OQR Program reduction). For
further discussion of the Hospital OQR Program, we refer readers to
section XV.F. of this final rule with comment period.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45103), we proposed to
amend 42 CFR 419.32(b)(1)(iv)(B) by adding a new paragraph (4) to
reflect the requirement in section 1833(t)(3)(F)(i) of the Act that,
for CY 2013, we reduce the OPD fee schedule increase factor by the MFP
adjustment as determined by CMS, and to reflect the requirement in
section 1833(t)(3)(G)(ii) of the Act, as required by section
1833(t)(3)(F)(ii) of the Act, that we reduce the OPD fee schedule
increase factor by an additional 0.1 percentage point for CY 2013.
Comment: Several commenters expressed support for the OPD fee
schedule increase factor because they believed it would better align
payment with hospital costs.
Response: We appreciate the commenters' support.
We did not receive any public comments on the proposed amendment to
42 CFR 419.32(b)(1)(iv)(B) to add a new paragraph (4) to reflect the
requirements in section 1833(t)(3)(F) of the Act. For the reasons
discussed above, we are adjusting the OPD fee schedule increase factor
and adopting as final the amendment to 42 CFR 419.32(b)(1)(iv)(B), as
proposed.
We did not receive any public comments on our proposed methodology
for calculating the CY 2013 conversion factor. Therefore, we are
finalizing our proposed methodology for calculating the budget
neutrality adjustment factors, as described in the following
discussion.
As we proposed, to set the OPPS conversion factor for CY 2013, we
are increasing the CY 2012 conversion factor of $70.016 by 1.8 percent.
In accordance with section 1833(t)(9)(B) of the Act, we are further
adjusting the conversion factor for CY 2013 to ensure that any
revisions made to the updates for a revised wage index and rural
adjustment are made on a budget neutral basis (77 FR 45103). We are
calculating an overall budget neutrality factor of 0.9998 for wage
index changes by comparing total estimated payments from our simulation
model using the final FY 2013 IPPS wage indices to those payments using
the current (FY 2012) IPPS wage indices, as adopted on a calendar year
basis for the OPPS.
For CY 2013, we did not propose to make a change to our rural
adjustment policy, and as discussed in section II.E. of this final rule
with comment period, we are not making any changes to the rural
adjustment policy. Therefore, the budget neutrality factor for the
rural adjustment is 1.0000.
For CY 2013, we are finalizing our proposal to continue previously
established policies for implementing the cancer hospital payment
adjustment described in section 1833(t)(18) of the Act, as discussed in
section II.F. of this final rule with comment period. We are
calculating a CY 2013 budget neutrality adjustment factor for the
cancer hospital payment adjustment by comparing the estimated total CY
2013 payments under section 1833(t) of the Act including the CY 2013
cancer hospital payment adjustment to the estimated CY 2013 total
payments using the CY 2012 final cancer hospital payment adjustment
under sections 1833(t)(18)(B) and 1833(t)(2)(E) of the Act. The
difference in the CY 2013 estimated payments as a result of applying
the CY 2013 cancer hospital payment adjustment relative to the CY 2012
final cancer hospital
[[Page 68285]]
payment adjustment does not have a significant impact on the budget
neutrality calculation. Therefore, we are applying a budget neutrality
adjustment factor of 1.0000 to the conversion factor to ensure that the
cancer hospital payment adjustment is budget neutral.
For this final rule with comment period, we estimate that pass-
through spending for both drugs and biologicals and devices for CY 2013
would equal approximately $74 million, which represents 0.15 percent of
total projected CY 2013 OPPS spending. Therefore, the conversion factor
is also adjusted by the difference between the 0.22 percent estimate of
pass-through spending for CY 2012 and the 0.15 percent estimate of CY
2013 pass-through spending, resulting in an adjustment for CY 2013 of -
0.07 percent. Finally, estimated payments for outliers remain at 1.0
percent of total OPPS payments for CY 2013.
The OPD fee schedule increase factor of 1.8 percent for CY 2013
(that is, the estimate of the hospital inpatient market basket
percentage increase of 2.6 percent less the 0.7 percentage point MFP
adjustment and less the 0.1 percentage point required under section
1833(t)(3)(F) of the Act), the required wage index budget neutrality
adjustment of approximately 0.9998, the cancer hospital payment
adjustment of 1.0000, and the adjustment of -0.07 percent of projected
OPPS spending for the difference in the pass-through spending result in
a conversion factor for CY 2013 of $71.313.
As we stated in the proposed rule, hospitals that fail to meet the
reporting requirements of the Hospital OQR Program will continue to be
subject to a further reduction of 2.0 percentage points to the OPD fee
schedule increase factor adjustment to the conversion factor that would
be used to calculate the OPPS payment rates made for their services as
required by section 1833(t)(17) of the Act. For a complete discussion
of the Hospital OQR Program requirements and the payment reduction for
hospitals that fail to meet those requirements, we refer readers to
section XV.F. of this final rule with comment period. To calculate the
CY 2013 reduced market basket conversion factor for those hospitals
that fail to meet the requirements of the Hospital OQR Program for the
full CY 2013 payment update, we are making all other adjustments
discussed above, but using a reduced OPD fee schedule update factor of
-0.2 percent (that is, the OPD fee schedule increase factor of 1.8
percent further reduced by 2.0 percentage points as required by section
1833(t)(17)(A)(i) of the Act for failure to comply with the Hospital
OQR requirements). This results in a reduced conversion factor for CY
2013 of $69.887 for those hospitals that fail to meet the Hospital OQR
requirements (a difference of -$1.426 in the conversion factor relative
to those hospitals that met the Hospital OQR requirements).
In summary, for CY 2013, we are using a final conversion factor of
$71.313 in the calculation of the national unadjusted payment rates for
those items and services for which payment rates are calculated using
geometric mean costs. For further discussion regarding our final policy
to base the CY 2013 OPPS relative payment weights on geometric mean
costs, we refer readers to section II.A.2.f. of this final rule with
comment period. We are finalizing our proposed amendment to Sec.
419.32(b)(1)(iv)(B) by adding a new paragraph (4) to reflect the
reductions to the OPD fee schedule increase factor that are required
for CY 2013 in order to satisfy the statutory requirements of sections
1833(t)(3)(F) and (t)(3)(G)(ii) of the Act. We also are using a reduced
conversion factor of $69.887 in the calculation of payments for
hospitals that fail to comply with the Hospital OQR Program
requirements to reflect the reduction to the OPD fee schedule increase
factor that is required by section 1833(t)(17) of the Act.
C. Wage Index Changes
Section 1833(t)(2)(D) of the Act requires the Secretary to
determine a wage adjustment factor to account for geographic wage
differences in a portion of the OPPS payment rate, which includes the
copayment standardized amount and is attributable to labor and labor-
related costs. This portion of the OPPS payment rate is called the OPPS
labor-related share. This adjustment must be made in a budget neutral
manner and budget neutrality is discussed in section II.B. of this
final rule with comment period.
The OPPS labor-related share is 60 percent of the national OPPS
payment. This labor-related share is based on a regression analysis
that determined that, for all hospitals, approximately 60 percent of
the costs of services paid under the OPPS were attributable to wage
costs. We confirmed that this labor-related share for outpatient
services is appropriate during our regression analysis for the payment
adjustment for rural hospitals in the CY 2006 OPPS final rule with
comment period (70 FR 68553). Therefore, as we proposed, we are not
revising this policy for the CY 2013 OPPS. We refer readers to section
II.H. of this final rule with comment period for a description and
example of how the wage index for a particular hospital is used to
determine the payment for the hospital.
As discussed in section II.A.2.c. of this final rule with comment
period, for estimating APC costs, we standardize 60 percent of
estimated claims costs for geographic area wage variation using the
same FY 2013 pre-reclassified wage index that the IPPS uses to
standardize costs. This standardization process removes the effects of
differences in area wage levels from the determination of a national
unadjusted OPPS payment rate and the copayment amount
As published in the original OPPS April 7, 2000 final rule with
comment period (65 FR 18545), the OPPS has consistently adopted the
final fiscal year IPPS wage index as the calendar year wage index for
adjusting the OPPS standard payment amounts for labor market
differences. Thus, the wage index that applies to a particular acute
care short-stay hospital under the IPPS also applies to that hospital
under the OPPS. As initially explained in the September 8, 1998 OPPS
proposed rule (63 FR 47576), we believed that using the IPPS wage index
as the source of an adjustment factor for the OPPS is reasonable and
logical, given the inseparable, subordinate status of the HOPD within
the hospital overall. In accordance with section 1886(d)(3)(E) of the
Act, the IPPS wage index is updated annually.
The Affordable Care Act contained provisions affecting the wage
index. These provisions were discussed in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74191). As discussed in that final rule
with comment period, section 10324 of the Affordable Care Act requires
a ``frontier State'' wage index floor of 1.00 in certain cases. For the
CY 2013 OPPS, as we proposed, we are implementing this provision in the
same manner as we did for CY 2012. That is, frontier State hospitals
will receive a wage index of 1.00 if the otherwise applicable wage
index (including reclassification, rural floor, and rural floor budget
neutrality) is less than 1.00. Similar to our current policy for HOPDs
that are affiliated with multicampus hospital systems, the HOPD will
receive a wage index based on the geographic location of the specific
inpatient hospital with which it is associated. Therefore, if the
associated hospital is located in a frontier State, the wage index
adjustment applicable for the hospital will also apply for the
affiliated HOPD. We refer readers to the FY 2011 and FY 2012 IPPS/LTCH
PPS final rules (75 FR 50160 through 50161 and 76 FR 51586,
respectively) and the FY 2013 IPPS/
[[Page 68286]]
LTCH PPS final rule (77 FR 53369 through 53370) for a detailed
discussion regarding this provision, including our methodology for
identifying which areas meet the definition of frontier States as
provided for in section 1886(d)(3)(E)(iii)(II) of the Act.
In addition to the changes required by the Affordable Care Act, we
note that the final FY 2013 IPPS wage indices continue to reflect a
number of adjustments implemented over the past few years, including,
but not limited to, reclassification of hospitals to different
geographic areas, the rural floor provisions, an adjustment for
occupational mix, and an adjustment to the wage index based on
commuting patterns of employees (the out-migration adjustment). We
refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53365
through 53374) for a detailed discussion of all changes to the FY 2013
IPPS wage indices. In addition, we refer readers to the CY 2005 OPPS
final rule with comment period (69 FR 65842 through 65844) and
subsequent OPPS rules for a detailed discussion of the history of these
wage index adjustments as applied under the OPPS.
Section 102 of the Medicare and Medicaid Extender Act extended,
through FY 2011, section 508 reclassifications as well as certain
special exceptions. The most recent extension of these special wage
indices was included in section 302 of the Temporary Payroll Tax Cut
Continuation Act of 2011 (Pub. L. 112-78), as amended by section 3001
of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L.
112-96). These legislative provisions extended certain section 508
reclassifications and special exception wage indices for a 6-month
period during FY 2012, from October 1, 2011 through March 31, 2012. We
implemented this extension in a notice (CMS-1442-N) published in the
Federal Register on April 20, 2012 (77 FR 23722). As we did for CY
2010, we revised wage index values for certain special exception
hospitals from January 1, 2012 through June 30, 2012, under the OPPS,
in order to give these hospitals the special exception wage indices
under the OPPS for the same time period as under the IPPS. In addition,
because the OPPS pays on a calendar year basis, the end date under the
OPPS for certain nonsection 508 and nonspecial exception providers to
receive special wage indices was June 30, 2012, instead of March 31,
2012, so that these providers also received a full 6 months of payment
under the revised wage index comparable to the IPPS. However, section
508 reclassifications and special exceptions have not been reauthorized
since their expiration under Pub. L. 112-96 and, therefore, are no
longer applicable.
For purposes of the OPPS, as we proposed, we are continuing our
policy in CY 2013 of allowing non-IPPS hospitals paid under the OPPS to
qualify for the out-migration adjustment if they are located in a
section 505 out-migration county (section 505 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)).
We note that, because non-IPPS hospitals cannot reclassify, they are
eligible for the out-migration wage adjustment. Table 4J listed in the
FY 2013 IPPS/LTCH PPS final rule (available via the Internet on the CMS
Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) identifies counties eligible for
the out-migration adjustment and hospitals that will receive the
adjustment for FY 2013. We note that, beginning with FY 2012, under the
IPPS, an eligible hospital that waives its Lugar status in order to
receive the out-migration adjustment has effectively waived its deemed
urban status and, thus, is rural for all purposes under the IPPS,
including being considered rural for the disproportionate share
hospital (DSH) payment adjustment, effective for the fiscal year in
which the hospital receives the out-migration adjustment. We refer
readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53371) for a
more detailed discussion on the Lugar redesignation waiver for the out-
migration adjustment). As we have done in prior years, we are including
Table 4J from the FY 2013 IPPS/LTCH PPS final rule as Addendum L to
this final rule with comment period with the addition of non-IPPS
hospitals that will receive the section 505 out-migration adjustment
under the CY 2013 OPPS. Addendum L is available via the Internet on the
CMS Web site.
In response to concerns frequently expressed by providers and other
relevant parties that the current wage index system does not
effectively reflect the true variation in labor costs for a large
cross-section of hospitals, two studies were undertaken by the
Department. First, section 3137(b) of the Affordable Care Act required
the Secretary to submit to Congress a report that includes a plan to
comprehensively reform the Medicare wage index applied under section
1886(d) of the Act. In developing the plan, the Secretary was directed
to take into consideration the goals for reforming the wage index that
were set forth by the Medicare Payment Advisory Commission (MedPAC) in
its June 2007 report entitled ``Report to Congress: Promoting Greater
Efficiency in Medicare'' and to ``consult with relevant affected
parties.'' Second, the Secretary commissioned the Institute of Medicine
(IOM) to ``evaluate hospital and physician geographic payment
adjustments, the validity of the adjustment factors, measures and
methodologies used in those factors, and sources of data used in those
factors.'' Reports on both of these studies for geographic adjustment
to hospital payments recently have been released. For summaries of the
studies, their findings, and recommendations on reforming the wage
index system, we refer readers to section IX.B. of the preamble of the
FY 2013 IPPS/LTCH PPS final rule (77 FR 53660 through 53664).
Comment: Several commenters expressed disappointment that CMS did
not set forth a proposal in the CY 2013 OPPS/ASC proposed rule to begin
reform of the wage index process and simply proposed to continue
adopting the IPPS fiscal year wage indexes. Several commenters
encouraged CMS to expedite wage index reform to create a more equitable
system that adequately pays hospitals for care provided to Medicare
beneficiaries. A few commenters supported the continuation of the
current wage index system; one commenter suggested that, as more
comprehensive reforms continue to be developed, they encompass the
goals of minimizing volatility, discouraging manipulation of the
system, and limiting adverse effects on high wage area markets.
Response: In the CY 2012 OPPS/ASC proposed rule, we solicited
comment on possible alternative wage index systems under the OPPS (76
FR 42212 through 42213). However, in the CY 2012 OPPS/ASC final rule
with comment period, we stated our belief that maintaining the current
policy of adopting the fiscal year IPPS wage index and adopting it in
the OPPS on a calendar year basis would continue to be appropriate,
given our longstanding use of the fiscal year IPPS wage index in the
OPPS on a calendar year basis (76 FR 74192) and the broader wage index
reform currently under development and consideration (76 FR 74193). In
the CY 2013 OPPS/ASC proposed rule, we proposed that continuing to use
the IPPS wage index as the source of an adjustment factor for the OPPS
is reasonable and logical, given the inseparable, subordinate status of
the HOPD within the hospital overall (77 FR 45105). As discussed above,
the FY 2013 IPPS/LTCH PPS final rule contains a discussion of a MedPAC
report and an IOM study focused on potential models for wage
[[Page 68287]]
index reform (77 FR 53660 through 53664).
After consideration of the public comments we received, we are
finalizing our policy to adopt the FY 2013 IPPS wage index for the CY
2013 OPPS in its entirety, including the rural floor, geographic
reclassifications, and all other wage index adjustments. As stated
earlier in this section, we continue to believe that using the IPPS
wage index as the source of an adjustment factor for the OPPS is
reasonable and logical, given the inseparable, subordinate status of
the HOPD within the hospital overall. Therefore, we are using the final
FY 2013 IPPS wage indices for calculating OPPS payments in CY 2013.
With the exception of the out-migration wage adjustment table (Addendum
L to this final rule with comment period, which is available via the
Internet on the CMS Web site), which includes non-IPPS hospitals paid
under the OPPS, we are not reprinting the final FY 2013 IPPS wage
indices referenced in this discussion of the wage index. We refer
readers to the CMS Web site for the OPPS at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. At this link, readers will find a link to the final FY 2013
IPPS wage index tables.
D. Statewide Average Default CCRs
In addition to using CCRs to estimate costs from charges on claims
for ratesetting, CMS uses overall hospital-specific CCRs calculated
from the hospital's most recent cost report to determine outlier
payments, payments for pass-through devices, and monthly interim
transitional corridor payments under the OPPS during the PPS year.
Medicare contractors cannot calculate a CCR for some hospitals because
there is no cost report available. For these hospitals, CMS uses the
statewide average default CCRs to determine the payments mentioned
above until a hospital's Medicare contractor is able to calculate the
hospital's actual CCR from its most recently submitted Medicare cost
report. These hospitals include, but are not limited to, hospitals that
are new, have not accepted assignment of an existing hospital's
provider agreement, and have not yet submitted a cost report. CMS also
uses the statewide average default CCRs to determine payments for
hospitals that appear to have a biased CCR (that is, the CCR falls
outside the predetermined ceiling threshold for a valid CCR) or for
hospitals in which the most recent cost report reflects an all-
inclusive rate status (Medicare Claims Processing Manual (Pub. 100-04),
Chapter 4, Section 10.11). We discuss our policy for using default
CCRs, including setting the ceiling threshold for a valid CCR, in the
CY 2009 OPPS/ASC final rule with comment period (73 FR 68594 through
68599) in the context of our adoption of an outlier reconciliation
policy for cost reports beginning on or after January 1, 2009.
For CY 2013, we proposed to continue to use our standard
methodology of calculating the statewide average default CCRs using the
same hospital overall CCRs that we use to adjust charges to costs on
claims data for setting the proposed CY 2013 OPPS relative payment
weights. Table 12 published in the proposed rule (77 FR 45106) listed
the proposed CY 2013 default urban and rural CCRs by State and compared
them to last year's default CCRs. These proposed CCRs represented the
ratio of total costs to total charges for those cost centers relevant
to outpatient services from each hospital's most recently submitted
cost report, weighted by Medicare Part B charges. We also proposed to
adjust ratios from submitted cost reports to reflect the final settled
status by applying the differential between settled to submitted
overall CCRs for the cost centers relevant to outpatient services from
the most recent pair of final settled and submitted cost reports. We
then proposed to weight each hospital's CCR by the volume of separately
paid line-items on hospital claims corresponding to the year of the
majority of cost reports used to calculate the overall CCRs. We refer
readers to the CY 2008 OPPS/ASC final rule with comment period (72 FR
66680 through 66682) and prior OPPS rules for a more detailed
discussion of our established methodology for calculating the statewide
average default CCRs, including the hospitals used in our calculations
and our trimming criteria.
Comment: One commenter expressed concern that Florida has the
lowest CCR in the United States for both rural and urban areas. The
commenter suggested that the statewide average default CCRs for Florida
are ``significantly skewed'' due to cost report information submitted
by hospitals in the Miami area and recommended that CMS evaluate the
data used to calculate the CCRs in order to validate this assumption.
Response: As detailed in the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66680 through 66682), we use only valid CCRs to
calculate the default ratios. That is, we remove the CCRs for all-
inclusive hospitals and CAHs, we identify and remove any obvious error
CCRs, and we trim any outliers. The Florida statewide average default
CCRs have been very stable over the last several years. Contrary to the
commenter's belief that we use statewide average default CCRs to
estimate the costs (from charges on claims) that are used to calculate
the OPPS relative weights, Medicare contractors use statewide average
default CCRs to determine outlier payments, payments for pass-through
devices, and monthly interim transitional corridor payments for
hospitals with no available cost report.
After consideration of the public comment we received on our CY
2013 proposal, we are finalizing our proposal to apply our standard
methodology of calculating the statewide average default CCRs using the
same hospital overall CCRs that we used to adjust charges to costs on
claims data for setting the CY 2013 OPPS relative weights. We used this
methodology to calculate the statewide average default CCRs listed in
Table 8 below.
For this CY 2013 OPPS/ASC final rule with comment period,
approximately 62 percent of the submitted cost reports utilized in the
default ratio calculations represented data for cost reporting periods
ending in CY 2010, and approximately 38 percent were for cost reporting
periods ending in CY 2009. For Maryland, we used an overall weighted
average CCR for all hospitals in the Nation as a substitute for
Maryland CCRs. Few hospitals in Maryland are eligible to receive
payment under the OPPS, which limits the data available to calculate an
accurate and representative CCR. The weighted CCR is used for Maryland
because it takes into account each hospital's volume, rather than
treating each hospital equally. We refer readers to the CY 2005 OPPS
final rule with comment period (69 FR 65822) for further discussion and
the rationale for our longstanding policy of using the national average
CCR for Maryland. In general, observed changes in the statewide average
default CCRs between CY 2012 and CY 2013 are modest and the few
significant changes are associated with areas that have a small number
of hospitals.
Table 8 below lists the finalized statewide average default CCRs
for OPPS services furnished on or after January 1, 2013.
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E. OPPS Payments to Certain Rural and Other Hospitals
1. Hold Harmless Transitional Payment Changes
The OPPS was implemented in CY 2000 under the Balanced Budget Act
of 1997 (BBA) (Pub. L. 105-33). The Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) made
major changes in the hospital OPPS, including adding a new paragraph
(7) to section 1833(t) of the Act, effective as if included in the
enactment of the BBA. Section 1833(t)(7) of the Act sets forth that
every provider was eligible to receive an additional payment adjustment
(called either transitional corridor payments or transitional
outpatient payments (TOPs)) if the payments it received for covered OPD
services under the OPPS were less than the payments it would have
received for the same services under the prior reasonable cost-based
system (referred to as the pre-BBA amount), and that the TOPs were
temporary payments for most providers and intended to ease their
transition from the prior reasonable cost-based payment system to the
OPPS system. There are two types
[[Page 68291]]
of hospitals excepted from the policy described above, cancer hospitals
and children's hospitals. Specifically, such a hospital could receive
TOPs to the extent its PPS amount was less than its pre-BBA amount in
the applicable year. Section 1833(t)(7)(D)(i) of the Act originally
provided for TOPs to all hospitals for covered OPD services furnished
before January 1, 2004. However, section 411 of Public Law 108-173 (the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003)
amended section 1833(t)(7)(D)(i) of the Act to extend these payments
through December 31, 2005, for rural hospitals with 100 or fewer beds.
Section 411 also extended the TOPs to sole community hospitals (SCHs)
located in rural areas for services furnished during the period that
began with the provider's first cost reporting period beginning on or
after January 1, 2004, and ending on December 31, 2005. Accordingly,
the authority for making TOPs under section 1833(t)(7)(D)(i) of the
Act, as amended by section 411 of Public Law 108-173, for rural
hospitals having 100 or fewer beds and SCHs located in rural areas
expired on December 31, 2005.
Section 5105 of Public Law 109-171 (the Deficit Reduction Act of
2005) extended the TOPs for covered OPD services furnished on or after
January 1, 2006, and before January 1, 2009, for rural hospitals having
100 or fewer beds that are not SCHs. Section 5105 of Public Law 109-171
also reduced the TOPs to rural hospitals from 100 percent of the
difference between the provider's OPPS payments and the pre-BBA amount.
This provision provided that, in cases in which the OPPS payment was
less than the provider's pre-BBA amount, the amount of payment would be
increased by 95 percent of the amount of the difference between the two
amounts for CY 2006, by 90 percent of the amount of that difference for
CY 2007, and by 85 percent of the amount of that difference for CY
2008.
For CY 2006, we implemented section 5105 of Public Law 109-171
through Transmittal 877, issued on February 24, 2006. In Transmittal
877, we did not specifically address whether TOPs applied to essential
access community hospitals (EACHs), which are considered to be SCHs
under section 1886(d)(5)(D)(iii)(III) of the Act. Accordingly, by law,
EACHs are treated as SCHs. In the CY 2007 OPPS/ASC final rule with
comment period (71 FR 68010), we stated that EACHs were not eligible
for TOPs under Public Law 109-171. However, we stated they were
eligible for the adjustment for rural SCHs authorized under section 411
of Public Law 108-173. In the CY 2007 OPPS/ASC final rule with comment
period (71 FR 68010 and 68228), we updated Sec. 419.70(d) of our
regulations to reflect the requirements of Public Law 109-171.
In the CY 2009 OPPS/ASC proposed rule (73 FR 41461), we stated
that, effective for services provided on or after January 1, 2009,
rural hospitals with 100 or fewer beds that are not SCHs would no
longer be eligible for TOPs, in accordance with section 5105 of Public
Law 109-171. However, subsequent to issuance of the CY 2009 OPPS/ASC
proposed rule, section 147 of Public Law 110-275 (the Medicare
Improvements for Patients and Providers Act of 2008) amended section
1833(t)(7)(D)(i) of the Act by extending the period of TOPs to rural
hospitals with 100 beds or fewer for 1 year, for services provided
before January 1, 2010. Section 147 of Public Law 110-275 also extended
TOPs to SCHs (including EACHs) with 100 or fewer beds for covered OPD
services provided on or after January 1, 2009, and before January 1,
2010. In accordance with section 147 of Public Law 110-275, when the
OPPS payment is less than the provider's pre-BBA amount, the amount of
payment is increased by 85 percent of the amount of the difference
between the two payment amounts for CY 2009.
For CY 2009, we revised our regulations at Sec. Sec. 419.70(d)(2)
and (d)(4) and added paragraph (d)(5) to incorporate the provisions of
section 147 of Public Law 110-275. In addition, we made other technical
changes to Sec. 419.70(d)(2) to more precisely capture our existing
policy and to correct an inaccurate cross-reference. We also made
technical corrections to the cross-references in paragraphs (e), (g),
and (i) of Sec. 419.70.
For CY 2010, we made a technical correction to the heading of Sec.
419.70(d)(5) to correctly identify the policy as described in the
subsequent regulation text. The paragraph heading now indicates that
the adjustment applies to small SCHs, rather than to rural SCHs.
In the CY 2010 OPPS/ASC final rule with comment period (74 FR
60425), we stated that, effective for services provided on or after
January 1, 2010, rural hospitals and SCHs (including EACHs) having 100
or fewer beds would no longer be eligible for TOPs, in accordance with
section 147 of Public Law 110-275. However, subsequent to the issuance
of the CY 2010 OPPS/ASC final rule with comment period, section 3121(a)
of the Affordable Care Act (Pub. L. 111-148) amended section
1833(t)(7)(D)(i)(III) of the Act by extending the period of TOPs to
rural hospitals that are not SCHs with 100 beds or fewer for 1 year,
for services provided before January 1, 2011. Section 3121(a) of the
Affordable Care Act amended section 1833(t)(7)(D)(i)(III) of the Act
and extended the period of TOPs to SCHs (including EACHs) for 1 year,
for services provided before January 1, 2011, and section 3121(b) of
the Affordable Care Act removed the 100-bed limitation applicable to
such SCHs for covered OPD services furnished on or after January 1,
2010, and before January 1, 2011. In accordance with section 3121 of
the Affordable Care Act, when the OPPS payment is less than the
provider's pre-BBA amount, the amount of payment is increased by 85
percent of the amount of the difference between the two payment amounts
for CY 2010. Accordingly, in the CY 2011 OPPS/ASC final rule with
comment period (75 FR 71882), we updated Sec. 419.70(d) of the
regulations to reflect the self-implementing TOPs extensions and
amendments described in section 3121 of the Affordable Care Act.
Section 108 of the Medicare and Medicaid Extenders Act of 2010
(MMEA) (Pub. L. 111-309) extended for 1 year the hold harmless
provision for a rural hospital with 100 or fewer beds that is not an
SCH (as defined in section 1886(d)(5)(D)(iii) of the Act). Therefore,
for such a hospital, for services furnished before January 1, 2012,
when the PPS amount is less than the provider's pre-BBA amount, the
amount of payment to the hospital is increased by 85 percent of the
amount of the difference between the two payments. In addition, section
108 of the MMEA also extended for 1 year the hold harmless provision
for an SCH (as defined in section 1886(d)(5)(D)(iii) of the Act
(including EACHs) and the removal of the 100-bed limit applicable to
such SCHs for covered OPD services furnished on or after January 1,
2010, and before January 1, 2012. Therefore, for such hospitals, for
services furnished before January 1, 2012, when the PPS amount is less
than the provider's pre-BBA amount, the amount of payment to the
hospital is increased by 85 percent of the amount of the difference
between the two payments. Effective for services provided on or after
January 1, 2012, a rural hospital with 100 or fewer beds that is not an
SCH and an SCH (including EACHs) are no longer eligible for TOPs, in
accordance with section 108 of the MMEA. In the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74199), we revised our
[[Page 68292]]
regulations Sec. 419.70(d) to conform the regulation text to the self-
implementing provisions of section 108 of the MMEA described above.
Subsequent to the issuance of the CY 2012 OPPS/ASC final rule with
comment period, section 308 of the Temporary Payroll Tax Cut
Continuation Act of CY 2011 (Pub. L. 112-78), as amended by section
3002 of the Middle Class Tax Relief and Jobs Creation Act (Pub. L. 112-
96), extended through December 31, 2012, the hold harmless provision
for a rural hospital with 100 or fewer beds that is not an SCH (as
defined in section 1886(d)(5)(D)(iii) of the Act). Therefore, for such
a hospital, for services furnished before January 1, 2013, when the PPS
amount is less than the provider's pre-BBA amount, the amount of
payment is increased by 85 percent of the amount of the difference
between the two payments.
Section 308 of Public Law 112-78 also extended through February 29,
2012, the hold harmless provision for an SCH (as defined in section
1886(d)(5)(D)(iii) of the Act), including an EACH, without the bed size
limitation. Therefore, for such hospitals, for services furnished
before March 1, 2012, when the PPS amount is less than the provider's
pre-BBA amount, the amount of payment is increased by 85 percent of the
amount of the difference between the two payments. However, section
3002 of Public Law 112-96 extended through December 31, 2012, the hold
harmless provision for an SCH (as defined in section 1886(d)(5)(D)(iii)
of the Act), including an EACH, that has no more than 100 beds.
Therefore, for such hospitals, for services furnished before January 1,
2013, when the PPS amount is less than the provider's pre-BBA amount,
the amount of payment is increased by 85 percent of the amount of the
difference between the two payments. Accordingly, as we proposed in the
CY 2013 OPPS/ASC proposed rule (77 FR 45108), we are revising Sec.
419.70(d) of the regulations to reflect the TOPs extensions and
amendments described in section 308 of Public Law 112-78 and section
3002 of Public Law 112-96.
Effective for services provided on or after March 1, 2012, SCHs
(including EACHs) with greater than 100 beds are no longer eligible for
TOPs, in accordance with section 308 of Public Law 112-78. Effective
for services provided on or after January 1, 2013, a rural hospital
with 100 or fewer beds that is not an SCH and an SCH (including an
EACH) are no longer eligible for TOPs, in accordance with section 3002
of Public Law 112-96.
2. Adjustment for Rural SCHs and EACHs Under Section 1833(t)(13)(B) of
the Act
In the CY 2006 OPPS final rule with comment period (70 FR 68556),
we finalized a payment increase for rural SCHs of 7.1 percent for all
services and procedures paid under the OPPS, excluding drugs,
biologicals, brachytherapy sources, and devices paid under the pass-
through payment policy in accordance with section 1833(t)(13)(B) of the
Act, as added by section 411 of Public Law 108-173. Section 411 gave
the Secretary the authority to make an adjustment to OPPS payments for
rural hospitals, effective January 1, 2006, if justified by a study of
the difference in costs by APC between hospitals in rural areas and
hospitals in urban areas. Our analysis showed a difference in costs for
rural SCHs. Therefore, for the CY 2006 OPPS, we finalized a payment
adjustment for rural SCHs of 7.1 percent for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, brachytherapy sources, and devices paid under the pass-
through payment policy, in accordance with section 1833(t)(13)(B) of
the Act.
In CY 2007, we became aware that we did not specifically address
whether the adjustment applies to EACHs, which are considered to be
SCHs under section 1886(d)(5)(D)(iii)(III) of the Act. Thus, under the
statute, EACHs are treated as SCHs. Therefore, in the CY 2007 OPPS/ASC
final rule with comment period (71 FR 68010 and 68227), for purposes of
receiving this rural adjustment, we revised Sec. 419.43(g) to clarify
that EACHs are also eligible to receive the rural SCH adjustment,
assuming these entities otherwise meet the rural adjustment criteria.
Currently, three hospitals are classified as EACHs, and as of CY 1998,
under section 4201(c) of Public Law 105-33, a hospital can no longer
become newly classified as an EACH.
This adjustment for rural SCHs is budget neutral and applied before
calculating outlier payments and copayments. We stated in the CY 2006
OPPS final rule with comment period (70 FR 68560) that we would not
reestablish the adjustment amount on an annual basis, but we may review
the adjustment in the future and, if appropriate, would revise the
adjustment. We provided the same 7.1 percent adjustment to rural SCHs,
including EACHs, again in CYs 2008 through 2012. Further, in the CY
2009 OPPS/ASC final rule with comment period (73 FR 68590), we updated
the regulations at Sec. 419.43(g)(4) to specify, in general terms,
that items paid at charges adjusted to costs by application of a
hospital-specific CCR are excluded from the 7.1 percent payment
adjustment.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45109), we proposed to
continue for CY 2013 our policy of a budget neutral 7.1 percent payment
adjustment for rural SCHs, including EACHs, for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, devices paid under the pass-through payment policy, and
items paid at charges reduced to costs. We indicated in the proposed
rule that we intend to reassess the 7.1 percent adjustment in the
future by examining differences between urban hospitals' costs and
rural hospitals' costs using updated claims data, cost reports, and
provider information.
Comment: Several commenters expressed support for the proposed
continuation of the 7.1 percent rural SCH adjustment. A few commenters
also suggested that the rural SCH adjustment also apply to urban SCHs.
One commenter suggested that the 7.1 percent payment adjustment also be
applied to MDHs, given that their inpatient classification was set to
expire in October 2012.
Response: We agree that it is appropriate to continue the 7.1
percent adjustment for rural SCHs (including EACHs) as we proposed for
CY 2013. We note that the rural SCH adjustment was developed under the
authority described in section 1833(t)(13) of the Act, which applies
specifically to rural hospitals. Although commenters have suggested
that the rural SCH adjustment also apply to urban SCHs, the study
authorized under section 1833(t)(13)(A) of the Act specifically focuses
on APC costs incurred by rural hospitals, as they exceed those costs
incurred by hospitals in urban areas. Moreover, the Secretary's
authority to make an adjustment based on that study was with respect to
a determination that costs incurred by rural hospitals exceed those
costs incurred by urban hospitals and to reflect those higher costs.
Therefore, the authority to make any such adjustment was limited to
reflect the higher costs incurred by such applicable rural hospitals.
Although the MDH classification is currently set to expire, we note
that the definition of a MDH at 1886(d)(5)(G)(iv)(III) of the Act
specifically excludes sole community hospitals, to which the rural
adjustment applies. Further, as we discussed in the CY 2006 OPPS final
rule, our analysis of urban SCHs as well as rural MDHs did not support
the application of a
[[Page 68293]]
rural adjustment (70 FR 68560 through 68561).
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal, without modification, to apply the 7.1
percent payment adjustment to rural SCHs, including EACHs, for all
services and procedures paid under the OPPS in CY 2013, excluding
separately payable drugs and biologicals, devices paid under the pass-
through payment policy, and items paid at charges reduced to costs. We
continue to believe that the adjustment is appropriate for application
in CY 2013.
F. OPPS Payment to Certain Cancer Hospitals Described by Section
1886(d)(1)(B)(v) of the Act
1. Background
Since the inception of the OPPS, which was authorized by the
Balanced Budget Act of 1997 (BBA), Medicare has paid cancer hospitals
identified in section 1886(d)(1)(B)(v) of the Act (cancer hospitals)
under the OPPS for covered outpatient hospital services. There are 11
cancer hospitals that meet the classification criteria in section
1886(d)(1)(B)(v) of the Act. These 11 cancer hospitals are exempted
from payment under the IPPS. With the Medicare, Medicaid and SCHIP
Balanced Budget Refinement Act of 1999, Congress created section
1833(t)(7) of the Act, ``Transitional Adjustment to Limit Decline in
Payment,'' to serve as a permanent payment floor by limiting cancer
hospitals' potential losses under the OPPS. Through section
1833(t)(7)(D)(ii) of the Act, a cancer hospital receives the full
amount of the difference between payments for covered outpatient
services under the OPPS and a ``pre-BBA'' amount. That is, cancer
hospitals are permanently held harmless to their ``pre-BBA'' amount,
and they receive TOPs to ensure that they do not receive a payment that
is lower under the OPPS than the payment they would have received
before implementation of the OPPS, as set forth in section
1833(t)(7)(F) of the Act. The ``pre-BBA'' payment amount is an amount
equal to the product of the reasonable cost of the hospital for covered
outpatient services for the portions of the hospital's cost reporting
period (or periods) occurring in the current year and the base payment-
to-cost ratio (PCR) for the hospital. The ``pre-BBA'' amount, including
the determination of the base PCR, are defined at 42 CFR 419.70(f).
TOPs are calculated on Worksheet E, Part B, of the Hospital and
Hospital Health Care Complex Cost Report (Form CMS-2552-96 or Form CMS-
2552-10, as applicable) each year. Section 1833(t)(7)(I) of the Act
exempts TOPs from budget neutrality calculations.
Section 3138 of the Affordable Care Act amended section 1833(t) of
the Act by adding a new paragraph (18), which instructs the Secretary
to conduct a study to determine if, under the OPPS, outpatient costs
incurred by cancer hospitals described in section 1886(d)(1)(B)(v) of
the Act with respect to APC groups exceed the costs incurred by other
hospitals furnishing services under section 1833(t) of the Act, as
determined appropriate by the Secretary. In addition, section 3138 of
the Affordable Care Act requires the Secretary to take into
consideration the cost of drugs and biologicals incurred by such
hospitals when studying cancer hospital costliness. Further, section
3138 of the Affordable Care Act provides that if the Secretary
determines that cancer hospitals' costs with respect to APC groups are
determined to be greater than the costs of other hospitals furnishing
services under section 1833(t) of the Act, the Secretary shall provide
an appropriate adjustment under section 1833(t)(2)(E) of the Act to
reflect these higher costs. After conducting the study required by
section 3138, we determined in 2012 that outpatient costs incurred by
the 11 specified cancer hospitals were greater than the costs incurred
by other OPPS hospitals. For a complete discussion regarding the cancer
hospital cost study, we refer readers to the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74200 through 74201).
Based on our findings that costs incurred by cancer hospitals were
greater than the costs incurred by other OPPS hospitals, we finalized a
policy to provide a payment adjustment to the 11 specified cancer
hospitals that reflects the higher outpatient costs as discussed in the
CY 2012 OPPS/ASC final rule with comment period (76 FR 74202 through
74206). Specifically, we adopted a policy to provide additional
payments to each of the 11 cancer hospitals so that each cancer
hospital's final PCR for services provided in a given calendar year is
equal to the weighted average PCR (which we refer to as the ``target
PCR'') for other hospitals paid under the OPPS. The target PCR is set
in advance of the calendar year and is calculated using the most recent
submitted or settled cost report data that are available at the time of
final rulemaking for the calendar year. The amount of the payment
adjustment is made on an aggregate basis at cost report settlement. We
note that the changes made by section 1833(t)(18) of the Act do not
affect the existing statutory provisions that provide for TOPs for
cancer hospitals. The TOPs are assessed as usual after all payments,
including the cancer hospital payment adjustment, have been made for a
cost reporting period. For CY 2012, the target PCR for purposes of the
cancer hospital payment adjustment is 0.91.
2. Payment Adjustment for Certain Cancer Hospitals for CY 2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45110), we proposed to
continue our policy to provide additional payments to cancer hospitals
so that each cancer hospital's final PCR is equal to the weighted
average PCR (or ``target PCR'') for the other OPPS hospitals using the
most recent submitted or settled cost report data that were available
at the time of the proposed rule. To calculate the proposed CY 2013
target PCR, we used the same extract of cost report data from HCRIS, as
discussed in section II.A. of the proposed rule, used to estimate costs
for the CY 2013 OPPS. Using these cost report data, we included data
from Worksheet E, Part B, for each hospital, using data from each
hospital's most recent cost report, whether as submitted or settled. We
estimated that, on average, the OPPS payments to other hospitals
furnishing services under the OPPS were approximately 91 percent of
reasonable cost (weighted average PCR of 0.91). Based on these data, we
proposed a target PCR of 0.91 that would be used to determine the CY
2013 cancer hospital payment adjustment that would be paid at cost
report settlement. Therefore, we proposed that the payment amount
associated with the cancer hospital payment adjustment to be determined
at cost report settlement would be the additional payment needed to
result in a proposed target PCR equal to 0.91 for each cancer hospital.
Comment: Some commenters suggested that the PCR is only one
component of the adjustment needed to account for the differences in
providing cancer care. The commenters suggested that CMS utilize a
methodology that they stated would ensure that the 11 cancer hospitals'
losses (on a per unit PCR basis) equal the losses (on a per unit PCR
basis) of the other PPS hospitals. The commenters provided details of
this ``equivalent loss per unit'' methodology which they indicate would
result in a target PCR equal to 0.94 for CY 2013.
Response: Section 3138 of the Affordable Care Act provides that if
the Secretary determines under section 1833(t)(18)(A) of the Act that
costs
[[Page 68294]]
incurred by cancer hospitals exceed those costs of other hospitals
furnishing services under section 1833(t), the Secretary shall provide
for an appropriate adjustment under section 1833(t)(2)(E) of the Act,
to reflect the higher costs. Because the statute requires that we
provide a cancer hospital payment adjustment to reflect the higher
costs, not losses, incurred at cancer hospitals, we believe that it
would be inappropriate to revise our cancer hospital payment adjustment
policy so that the target PCR is calculated based on the cancer
hospitals' losses per unit PCR compared to the other OPPS hospitals'
losses per unit PCR.
Comment: Commenters stated that CMS should not recalculate the
target PCR annually because the cancer hospitals require payment
stability and predictability in order to provide services to Medicare
beneficiaries.
Response: We believe that annual recalculation of the target PCR
will provide a timely assessment of the changes in OPPS payments
relative to costs and, therefore, will enable us to provide payment
adjustments to cancer hospitals that are accurate and equitable. In
addition, it is unlikely that the target PCR (the weighted average PCR
for the other OPPS hospitals) would fluctuate significantly from year
to year. The target PCR is 0.91 for purposes of the CY 2012 cancer
hospital payment adjustment and remained at 0.91 when recalculated for
the CY 2013 OPPS/ASC proposed rule and this final rule with comment
period. In addition to the apparent stability of the target PCR,
because the target PCR is set in advance of each calendar year, cancer
hospitals can easily predict the amount of their hospital-specific
payment adjustment associated with the target PCR for the following
year and budget accordingly.
Comment: Commenters stated that CMS must make the cancer hospital
payment adjustment effective for services furnished on or after January
1, 2011, in order to comply with section 3138 of the Affordable Care
Act.
Response: As explained in the CY 2011 OPPS/ASC final rule with
comment period (75 FR 71886 through 71887), we did not finalize the
proposed cancer hospital adjustment for CY 2011 for a variety of
reasons, including, ultimately, a determination that further study and
deliberation of the issues were necessary. The obligation to provide a
cancer hospital payment adjustment is triggered only insofar as the
Secretary determines under section 1833(t)(18)(A) of the Act that costs
incurred by hospitals described in section 1886(d)(1)(B)(v) of the Act
exceed those costs incurred by other hospitals furnishing services
under that subsection. Several commenters on the CY 2011 OPPS/ASC
proposed rule raised concerns about the agency's study of costliness
conducted under section 1833(t)(18)(A) of the Act; for example, one
commenter suggested that the CMS analysis was inadequate to conclude
that costs are higher in cancer hospitals and that an adjustment was
warranted. Given the uncertainty surrounding these issues, public
comments arguing against implementing a cancer hospital payment
adjustment for CY 2011, and our determination that further study and
deliberation were necessary, we decided to not finalize a cancer
hospital payment adjustment for CY 2011. We note that, because the
cancer hospital payment adjustment is budget neutral, the lack of a
cancer hospital payment adjustment for CY 2011 also meant that other
payments were not reduced for CY 2011 to offset the increased payments
from the adjustment.
Comment: One commenter noted that, although CMS indicated the
estimated percent by which each cancer hospital's OPPS payments would
be increased under the cancer hospital payment adjustment policy in the
CY 2012 OPPS/ASC proposed and final rules, CMS did not include this
information in the CY 2013 OPPS/ASC proposed rule. The commenter
requested that CMS include this information in the CY 2013 OPPS/ASC
final rule with comment period.
Response: We agree with the commenter that it would be informative
to provide the estimated percentage increase in CY 2013 OPPS payments
to each cancer hospital due to the cancer hospital payment adjustment
policy. Therefore, we are including that information in the last column
of Table 9 below.
After consideration of the public comments we received, we are
finalizing our proposal to continue our policy to provide additional
payments to cancer hospitals so that each cancer hospital's final PCR
is equal to the weighted average PCR for the other OPPS hospitals using
the most recent submitted or settled cost report data that were
available at the time of this final rule with comment period. To
calculate the final CY 2013 target PCR, we used the same extract of
cost report data from HCRIS, as discussed in section II.A. of this
final rule with comment period, used to estimate costs for the CY 2013
OPPS. Using these cost report data, we included data from Worksheet E,
Part B, for each hospital, using data from each hospital's most recent
cost report, whether as submitted or settled. We then limited the
dataset to the hospitals with CY 2011 claims data that we used to model
the impact of the final CY 2013 APC relative weights (4,026 hospitals)
because it is appropriate to use the same set of hospitals that we are
using to calibrate the modeled CY 2013 OPPS. The cost report data for
the hospitals in this dataset were from cost report periods with fiscal
year ends ranging from 2010 to 2011. We then removed the cost report
data of the 48 hospitals located in Puerto Rico from our dataset
because we do not believe that their cost structure reflects the costs
of most hospitals paid under the OPPS and, therefore, their inclusion
may bias the calculation of hospital-weighted statistics. We also
removed the cost report data of 182 hospitals because the cost report
data that were not complete (missing aggregate OPPS payments, missing
aggregate cost data, or missing both), so that all cost reports in the
study would have both the payment and cost data necessary to calculate
a PCR for each hospital, leading to an analytic file of 3,796 hospitals
with cost report data.
Using this smaller dataset of cost report data, we estimated that,
on average, the OPPS payments to other hospitals furnishing services
under the OPPS are approximately 91 percent of reasonable cost
(weighted average PCR of 0.91). Based on these data, we will use a
target PCR of 0.91 to determine the CY 2013 cancer hospital payment
adjustment to be paid at cost report settlement. Therefore, the payment
amount associated with the cancer hospital payment adjustment to be
determined at cost report settlement will be the additional payment
needed to result in a PCR equal to 0.91 for each cancer hospital.
Table 9 below indicates the estimated percentage increase in OPPS
payments to each cancer hospital for CY 2013 due to the cancer hospital
payment adjustment policy. The actual amount of the CY 2013 cancer
hospital payment adjustment for each cancer hospital will be determined
at cost report settlement and will depend on each hospital's CY 2013
payments and costs. We note that the changes made by section
1833(t)(18) of the Act do not affect the existing statutory provisions
that provide for TOPs for cancer hospitals. The TOPs will be assessed
as usual after all payments, including the cancer hospital payment
adjustment, have been made for a cost reporting period.
[[Page 68295]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.019
G. Hospital Outpatient Outlier Payments
1. Background
Currently, the OPPS provides outlier payments on a service-by-
service basis. In CY 2011, the outlier threshold was determined to be
met when the cost of furnishing a service or procedure by a hospital
exceeds 1.75 times the APC payment amount and exceeds the APC payment
rate plus a $2,025 fixed-dollar threshold. We introduced a fixed-dollar
threshold in CY 2005, in addition to the traditional multiple
threshold, in order to better target outlier payments to those high-
cost and complex procedures where a very costly service could present a
hospital with significant financial loss. If the cost of a service
meets both of these conditions, the multiple threshold and the fixed-
dollar threshold, the outlier payment is calculated as 50 percent of
the amount by which the cost of furnishing the service exceeds 1.75
times the APC payment rate. Before CY 2009, this outlier payment had
historically been considered a final payment by longstanding OPPS
policy. However, we implemented a reconciliation process similar to the
IPPS outlier reconciliation process for cost reports with cost
reporting periods beginning on or after January 1, 2009, in our CY 2009
OPPS/ASC final rule with comment period (73 FR 68594 through 68599).
It has been our policy for the past several years to report the
actual amount of outlier payments as a percent of total spending in the
claims being used to model the proposed OPPS. Our current estimate of
total outlier payments as a percent of total CY 2011 OPPS payment,
using available CY 2011 claims and the revised OPPS expenditure
estimate for the 2012 Trustee's Report, is approximately 1.2 percent of
the total aggregated OPPS payments. Therefore, for CY 2011, we estimate
that we paid 0.2 percent above the CY 2011 outlier target of 1.0
percent of total aggregated OPPS payments.
As explained in the CY 2012 OPPS/ASC final rule with comment period
(77 FR 74207 through 74209), we set our projected target for aggregate
outlier payments at 1.0 percent of the estimated aggregate total
payments under the OPPS for CY 2012. The outlier thresholds were set so
that estimated CY 2012 aggregate outlier payments would equal 1.0
percent of the total estimated aggregate payments under the OPPS. Using
CY 2011 claims data and CY 2012 payment rates, we currently estimate
that the aggregate outlier payments for CY 2012 will be approximately
0.9 percent of the total CY 2012 OPPS payments. The difference between
1.0 percent and 0.9 percent is reflected in the regulatory impact
analysis in section XXII. of this final rule with comment period. We
note that we provide estimated CY 2013 outlier payments for hospitals
and CMHCs with claims included in the claims data that we used to model
impacts in the Hospital-Specific Impacts--Provider-Specific Data file
on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
2. Proposed Outlier Calculation
In the CY 2013 OPPS/ASC proposed rule (77 FR 45110), we proposed to
continue for CY 2013 our policy of estimating outlier payments to be
1.0 percent of the estimated aggregate total payments under the OPPS
for outlier payments. We proposed that a portion of that 1.0 percent,
an amount equal to 0.12 percent of outlier payments (or 0.0012 percent
of total OPPS payments) would be allocated to CMHCs for PHP outlier
payments. This is the amount of estimated outlier payments that would
result from the proposed CMHC outlier
[[Page 68296]]
threshold as a proportion of total estimated OPPS outlier payments. As
discussed in section VIII.C. of the CY 2013 OPPS/ASC proposed rule, for
CMHCs, we proposed to continue our longstanding policy that if a CMHC's
cost for partial hospitalization services, paid under either APC 0172
(Level I Partial Hospitalization (3 services) for CMHCs) or APC 0173
(Level II Partial Hospitalization (4 or more services) for CMHCs),
exceeds 3.40 times the payment rate for APC 0173, the outlier payment
would be calculated as 50 percent of the amount by which the cost
exceeds 3.40 times the APC 0173 payment rate. For further discussion of
CMHC outlier payments, we refer readers to section VIII.C. of this
final rule with comment period.
To ensure that the estimated CY 2013 aggregate outlier payments
would equal 1.0 percent of estimated aggregate total payments under the
OPPS, we proposed that the hospital outlier threshold be set so that
outlier payments would be triggered when the cost of furnishing a
service or procedure by a hospital exceeds 1.75 times the APC payment
amount and exceeds the APC payment rate plus a $2,400 fixed-dollar
threshold.
We proposed to calculate the fixed-dollar threshold using largely
the same methodology as we did in CYs 2011 and 2012 (75 FR 71887
through 71889 and 76 FR 74207 through 74209). For purposes of
estimating outlier payments for the proposed rule, we used the
hospital-specific overall ancillary CCRs available in the April 2012
update to the Outpatient Provider-Specific File (OPSF). The OPSF
contains provider-specific data, such as the most current CCR, which
are maintained by the Medicare contractors and used by the OPPS Pricer
to pay claims. The claims that we use to model each OPPS update lag by
2 years.
In order to estimate the CY 2013 hospital outlier payments for the
proposed rule, we inflated the charges on the CY 2011 claims using the
same inflation factor of 1.1406 that we used to estimate the IPPS
fixed-dollar outlier threshold for the FY 2013 IPPS/LTCH PPS proposed
rule (77 FR 28142). We used an inflation factor of 1.0680 to estimate
CY 2012 charges from the CY 2011 charges reported on CY 2011 claims.
The methodology for determining this charge inflation factor is
discussed in the FY 2013 IPPS/LTCH PPS proposed rule (77 FR 28142). As
we stated in the CY 2005 OPPS final rule with comment period (69 FR
65845), we believe that the use of these charge inflation factors are
appropriate for the OPPS because, with the exception of the inpatient
routine service cost centers, hospitals use the same ancillary and
outpatient cost centers to capture costs and charges for inpatient and
outpatient services.
As noted in the CY 2007 OPPS/ASC final rule with comment period (71
FR 68011), we are concerned that we could systematically overestimate
the OPPS hospital outlier threshold if we did not apply a CCR inflation
adjustment factor. Therefore, we proposed in the CY 2013 OPPS/ASC
proposed rule to apply the same CCR inflation adjustment factor that we
applied for the FY 2013 IPPS outlier calculation to the CCRs used to
simulate the CY 2013 OPPS outlier payments to determine the fixed-
dollar threshold. Specifically, for CY 2013, we proposed to apply an
adjustment factor of 0.9790 to the CCRs that were in the April 2012
OPSF to trend them forward from CY 2012 to CY 2013. The methodology for
calculating this proposed adjustment was discussed in the FY 2013 IPPS/
LTCH PPS proposed rule (77 FR 28142 through 28144). We note that, due
to the issue described in the IPPS proposed rule correction notice
published on June 11, 2012, the operating and capital CCR inflation
factors were reversed (77 FR 34326). In estimating the proposed CY 2013
OPPS fixed-dollar outlier threshold, we applied the corrected CCR
inflation factor.
Therefore, to model hospital outlier payments for the proposed
rule, we applied the overall CCRs from the April 2012 OPSF file after
adjustment (using the proposed CCR inflation adjustment factor of
0.9790 to approximate CY 2013 CCRs) to charges on CY 2011 claims that
were adjusted (using the charge inflation factor of 1.1406 to
approximate CY 2013 charges). We simulated aggregated CY 2013 hospital
outlier payments using these costs for several different fixed-dollar
thresholds, holding the 1.75 multiple threshold constant and assuming
that outlier payments would continue to be made at 50 percent of the
amount by which the cost of furnishing the service would exceed 1.75
times the APC payment amount, until the total outlier payments equaled
1.0 percent of aggregated estimated total CY 2013 OPPS payments. We
estimated that a proposed fixed-dollar threshold of $2,400, combined
with the multiple threshold of 1.75 times the APC payment rate, would
allocate 1.0 percent of aggregated total OPPS payments to outlier
payments. We proposed to continue to make an outlier payment that
equals 50 percent of the amount by which the cost of furnishing the
service exceeds 1.75 times the APC payment amount when both the 1.75
multiple threshold and the proposed fixed-dollar threshold of $2,400
were met. For CMHCs, we proposed that, if a CMHC's cost for partial
hospitalization services, paid under either APC 0172 or APC 0173,
exceeds 3.40 times the payment rate for APC 0173, the outlier payment
would be calculated as 50 percent of the amount by which the cost
exceeds 3.40 times the APC 0173 payment rate.
Section 1833(t)(17)(A) of the Act, which applies to hospitals as
defined under section 1886(d)(1)(B) of the Act, requires that hospitals
that fail to report data required for the quality measures selected by
the Secretary, in the form and manner required by the Secretary under
1833(t)(17)(B) of the Act, incur a 2.0 percentage point reduction to
their OPD fee schedule increase factor, that is, the annual payment
update factor. The application of a reduced OPD fee schedule increase
factor results in reduced national unadjusted payment rates that will
apply to certain outpatient items and services furnished by hospitals
that are required to report outpatient quality data and that fail to
meet the Hospital OQR Program requirements. For hospitals that fail to
meet the Hospital OQR Program requirements, we proposed to continue the
policy that we implemented in CY 2010 that the hospitals' costs will be
compared to the reduced payments for purposes of outlier eligibility
and payment calculation. For more information on the Hospital OQR
Program, we refer readers to section XV. of this final rule with
comment period.
Comment: Several commenters expressed concern with respect to the
relative increase in the proposed CY 2013 OPPS fixed-dollar outlier
threshold of $2,400. The commenters believed that the increase in the
fixed-dollar threshold would bring about a drastic reduction in outlier
payments as well as the ability to furnish services to beneficiaries.
Commenters also suggested CMS to reconsider the fixed-dollar threshold
value, confirm that the data used to develop the threshold were
accurate, and provide data to support the increase in the threshold.
Commenters also suggested alternative fixed-dollar threshold setting
methodologies such as a 3-year transition to the threshold or a
calculation based on prior year estimated percent OPPS outlier
spending.
Response: As indicated above, we introduced a fixed-dollar
threshold in order to better target outlier payments to those high-cost
and complex procedures where a very costly service could present a
hospital with significant
[[Page 68297]]
financial loss. We maintain the target outlier percentage of 1.0
percent of estimated aggregate total payment under the OPPS and have a
fixed-dollar threshold so that OPPS outlier payments are made only when
the hospital would experience a significant loss for supplying a
particular service. While commenters have expressed concern based on
the assumption that OPPS outlier payments made under an increased
fixed-dollar threshold would decrease, we note that the threshold may
increase or decrease from year to year, to maintain the 1.0 percent
outlier spending target. While we described issues related to the
charge and CCR inflation factors in the CY 2013 OPPS/ASC proposed rule,
there were no other errors in the methodology (77 FR 45111). The
methodology for determining the OPPS fixed-dollar threshold is
described in this section, the LDS files used to model the threshold
that are available for public purchase, and a detailed claims
accounting document that is available online, which all support the
determination of the fixed-dollar threshold. We do not believe that a
transitional methodology to determine the outlier threshold or a
methodology that takes into account prior spending is appropriate
because the relationship between a hospital's costs and the APC payment
rates changes each year.
3. Final Outlier Calculation
Consistent with historical practice, we use updated data for this
final rule with comment period for our outlier calculation. For CY
2013, we are applying the overall CCRs from the July 2012 OPSF with a
CCR adjustment factor of 0.9880 to approximate CY 2013 CCRs to charges
on the final CY 2011 claims that were adjusted to approximate CY 2013
charges (using the final 2-year charge inflation factor of 1.0894).
These are the same CCR adjustment and charge inflation factors that
were used to set the IPPS fixed-dollar threshold for the FY 2013 IPPS/
LTCH PPS final rule (77 FR 53695 through 53696). We simulated
aggregated CY 2013 hospital outlier payments using these costs for
several different fixed-dollar thresholds, holding the 1.75 multiple
threshold constant and assuming that outlier payment would continue to
be made at 50 percent of the amount by which the cost of furnishing the
service would exceed 1.75 times the APC payment amount, until the total
outlier payments equaled 1.0 percent of aggregated estimated total CY
2013 OPPS payments. We estimate that a fixed-dollar threshold of
$2,025, combined with the multiple threshold of 1.75 times the APC
payment rate, will allocate 1.0 percent of estimated aggregated total
OPPS payments to outlier payments.
In summary, for CY 2013, we will continue to make an outlier
payment that equals 50 percent of the amount by which the cost of
furnishing the service exceeds 1.75 times the APC payment amount when
both the 1.75 multiple threshold and the final fixed-dollar threshold
of $2,025 are met. For CMHCs, if a CMHC's cost for partial
hospitalization services, paid under either APC 0172 or APC 0173,
exceeds 3.40 times the payment rate for APC 0173, the outlier payment
is calculated as 50 percent of the amount by which the cost exceeds
3.40 times the APC 0173 payment rate. We estimate that this threshold
will allocate 0.12 percent of outlier payments to CMHCs for PHP outlier
payments.
4. Outlier Reconciliation
In the CY 2009 OPPS/ASC final rule with comment period (73 CFR
68599), we adopted as final policy a process to reconcile hospital or
CMHC outlier payments at cost report settlement for services furnished
during cost reporting periods beginning in CY 2009. OPPS outlier
reconciliation more fully ensures accurate outlier payments for those
facilities that have CCRs that fluctuate significantly relative to the
CCRs of other facilities, and that receive a significant amount of
outlier payments (73 FR 68598). As under the IPPS, we do not adjust the
fixed-dollar threshold or the amount of total OPPS payments set aside
for outlier payments for reconciliation activity because such action
would be contrary to the prospective nature of the system. Our outlier
threshold calculation assumes that overall ancillary CCRs accurately
estimate hospital costs based on the information available to us at the
time we set the prospective fixed-dollar outlier threshold. For these
reasons, and as we have previously discussed in the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68596), and as we proposed for CY
2013, we are not incorporating any assumptions about the effects of
reconciliation into our calculation of the OPPS fixed-dollar outlier
threshold in this final rule with comment period.
H. Calculation of an Adjusted Medicare Payment From the National
Unadjusted Medicare Payment
The basic methodology for determining prospective payment rates for
HOPD services under the OPPS is set forth in existing regulations at 42
CFR part 419, subparts C and D. For this final rule with comment
period, the payment rate for most services and procedures for which
payment is made under the OPPS is the product of the conversion factor
calculated in accordance with section II.B. of this final rule with
comment period and the relative payment weight determined under section
II.A. of this final rule with comment period. Therefore, the national
unadjusted payment rate for most APCs contained in Addendum A to this
final rule with comment period (which is available via the Internet on
the CMS Web site) and for most HCPCS codes to which separate payment
under the OPPS has been assigned in Addendum B to this final rule with
comment period (which is available via the Internet on the CMS Web
site) was calculated by multiplying the CY 2013 scaled weight for the
APC by the CY 2013 conversion factor.
We note that section 1833(t)(17) of the Act, which applies to
hospitals as defined under section 1886(d)(1)(B) of the Act, requires
that hospitals that fail to submit data required to be submitted on
quality measures selected by the Secretary, in the form and manner and
at a time specified by the Secretary, incur a reduction of 2.0
percentage points to their OPD fee schedule increase factor, that is,
the annual payment update factor. The application of a reduced OPD fee
schedule increase factor results in reduced national unadjusted payment
rates that apply to certain outpatient items and services provided by
hospitals that are required to report outpatient quality data and that
fail to meet the Hospital OQR Program (formerly referred to as the
Hospital Outpatient Quality Data Reporting Program (HOP QDRP))
requirements. For further discussion of the payment reduction for
hospitals that fail to meet the requirements of the Hospital OQR
Program, we refer readers to section XV. of this final rule with
comment period.
We demonstrate in the steps below how to determine the APC payments
that will be made in a calendar year under the OPPS to a hospital that
fulfills the Hospital OQR Program requirements and to a hospital that
fails to meet the Hospital OQR Program requirements for a service that
has any of the following status indicator assignments: ``P,'' ``Q1,''
``Q2,'' ``Q3,'' ``R,'' ``S,'' ``T,'' ``U,'' ``V,'' or ``X'' (as defined
in Addendum D1 to this final rule with comment period), in a
circumstance in which the multiple procedure discount does not apply,
the procedure is not bilateral, and conditionally packaged services
(status indicator of ``Q1'' and ``Q2'') qualify for separate payment.
We note that,
[[Page 68298]]
although blood and blood products with status indicator ``R'' and
brachytherapy sources with status indicator ``U'' are not subject to
wage adjustment, they are subject to reduced payments when a hospital
fails to meet the Hospital OQR Program requirements.
We did not receive any public comments on the proposed calculation
of an adjusted Medicare payment. Therefore, we are finalizing the
calculation of an adjusted Medicare payment, where appropriate, in the
manner described as follows. Individual providers interested in
calculating the payment amount that they will receive for a specific
service from the national unadjusted payment rates presented in Addenda
A and B to this final rule with comment period (which are available via
the Internet on the CMS Web site) should follow the formulas presented
in the following steps. For purposes of the payment calculations below,
we refer to the national unadjusted payment rate for hospitals that
meet the requirements of the Hospital OQR Program as the ``full''
national unadjusted payment rate. We refer to the national unadjusted
payment rate for hospitals that fail to meet the requirements of the
Hospital OQR Program as the ``reduced'' national unadjusted payment
rate. The reduced national unadjusted payment rate is calculated by
multiplying the reporting ratio of 0.980 times the ``full'' national
unadjusted payment rate. The national unadjusted payment rate used in
the calculations below is either the full national unadjusted payment
rate or the reduced national unadjusted payment rate, depending on
whether the hospital met its Hospital OQR Program requirements in order
to receive the full CY 2013 OPPS fee schedule increase factor of 1.8
percent.
Step 1. Calculate 60 percent (the labor-related portion) of the
national unadjusted payment rate. Since the initial implementation of
the OPPS, we have used 60 percent to represent our estimate of that
portion of costs attributable, on average, to labor. We refer readers
to the April 7, 2000 OPPS final rule with comment period (65 FR 18496
through 18497) for a detailed discussion of how we derived this
percentage. We confirmed that this labor-related share for hospital
outpatient services is appropriate during our regression analysis for
the payment adjustment for rural hospitals in the CY 2006 OPPS final
rule with comment period (70 FR 68553).
The formula below is a mathematical representation of Step 1 and
identifies the labor-related portion of a specific payment rate for a
specific service.
X is the labor-related portion of the national unadjusted payment
rate.
X = .60 * (national unadjusted payment rate)
Step 2. Determine the wage index area in which the hospital is
located and identify the wage index level that applies to the specific
hospital. The wage index values assigned to each area reflect the
geographic statistical areas (which are based upon OMB standards) to
which hospitals are assigned for FY 2013 under the IPPS,
reclassifications through the MGCRB, section 1886(d)(8)(B) ``Lugar''
hospitals, reclassifications under section 1886(d)(8)(E) of the Act, as
defined in Sec. 412.103 of the regulations, and hospitals designated
as urban under section 601(g) of Public Law 98-21. We note that the
reclassifications of hospitals under section 508 of Public Law 108-173,
as extended by sections 3137 and 10317 of the Affordable Care Act,
expired on September 30, 2010. Section 102 of the Medicare and Medicaid
Extenders Act of 2010 extended section 508 and certain additional
special exception hospital reclassifications from October 1, 2010
through September 30, 2011. Section 302 of the Temporary Payroll Tax
Cut Continuation Act of 2011 (Pub. L. 112-78) as amended by section
3001 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub.
L. 112-96) extended section 508 and certain additional special
exception hospital reclassifications from October 1, 2011 through March
31, 2012. Therefore, these reclassifications will not apply to the CY
2013 OPPS. (For further discussion of the changes to the FY 2013 IPPS
wage indices, as applied to the CY 2013 OPPS, we refer readers to
section II.C. of this final rule with comment period). We proposed to
continue to apply a wage index floor of 1.00 to frontier States, in
accordance with section 10324 of the Affordable Care Act.
Step 3. Adjust the wage index of hospitals located in certain
qualifying counties that have a relatively high percentage of hospital
employees who reside in the county, but who work in a different county
with a higher wage index, in accordance with section 505 of Public Law
108-173. Addendum L to this final rule with comment period (which is
available via the Internet on the CMS Web site) contains the qualifying
counties and the associated wage index increase developed for the FY
2013 IPPS and listed as Table 4J in the FY 2013 IPPS/LTCH PPS final
rule and available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. This step is to be followed only if the
hospital is not reclassified or redesignated under section 1886(d)(8)
or section 1886(d)(10) of the Act.
Step 4. Multiply the applicable wage index determined under Steps 2
and 3 by the amount determined under Step 1 that represents the labor-
related portion of the national unadjusted payment rate.
The formula below is a mathematical representation of Step 4 and
adjusts the labor-related portion of the national unadjusted payment
rate for the specific service by the wage index.
Xa is the labor-related portion of the national unadjusted payment
rate (wage adjusted).
X a = .60 * (national unadjusted payment rate) * applicable wage
index.
Step 5. Calculate 40 percent (the nonlabor-related portion) of the
national unadjusted payment rate and add that amount to the resulting
product of Step 4. The result is the wage index adjusted payment rate
for the relevant wage index area.
The formula below is a mathematical representation of Step 5 and
calculates the remaining portion of the national payment rate, the
amount not attributable to labor, and the adjusted payment for the
specific service.
Y is the nonlabor-related portion of the national unadjusted
payment rate.
Y = .40 * (national unadjusted payment rate)
Adjusted Medicare Payment = Y + X a
Step 6. If a provider is an SCH, set forth in the regulations at
Sec. 412.92, or an EACH, which is considered to be an SCH under
section 1886(d)(5)(D)(iii)(III) of the Act, and located in a rural
area, as defined in Sec. 412.64(b), or is treated as being located in
a rural area under Sec. 412.103, multiply the wage index adjusted
payment rate by 1.071 to calculate the total payment.
The formula below is a mathematical representation of Step 6 and
applies the rural adjustment for rural SCHs.
Adjusted Medicare Payment (SCH or EACH) = Adjusted Medicare Payment *
1.071
We have provided examples below of the calculation of both the full
and reduced national unadjusted payment rates that will apply to
certain outpatient items and services performed by hospitals that meet
and that fail to meet the Hospital OQR Program requirements, using the
steps outlined above. For purposes of this example, we used a provider
that is located in Brooklyn, New York that is assigned to CBSA 35644.
This provider bills one service that is assigned to APC 0019
[[Page 68299]]
(Level I Excision/Biopsy). The CY 2013 full national unadjusted payment
rate for APC 0019 is $336.38. The reduced national unadjusted payment
rate for a hospital that fails to meet the Hospital OQR Program
requirements is $329.65. This reduced rate is calculated by multiplying
the reporting ratio of 0.980 by the full unadjusted payment rate for
APC 0019.
The FY 2013 wage index for a provider located in CBSA 35644 in New
York is 1.2971. The labor-related portion of the full national
unadjusted payment is $261.79 (.60 * $336.38 * 1.2971). The labor-
related portion of the reduced national unadjusted payment is $256.55
(.60 * $329.65 * 1.2971). The nonlabor-related portion of the full
national unadjusted payment is $134.55 (.40 * $336.38). The nonlabor-
related portion of the reduced national unadjusted payment is $131.86
(.40 * $329.65). The sum of the labor-related and nonlabor-related
portions of the full national adjusted payment is $396.34 ($261.79 +
$134.55). The sum of the reduced national adjusted payment is $388.41
($256.55 + $131.86).
I. Beneficiary Copayments
1. Background
Section 1833(t)(3)(B) of the Act requires the Secretary to set
rules for determining the unadjusted copayment amounts to be paid by
beneficiaries for covered OPD services. Section 1833(t)(8)(C)(ii) of
the Act specifies that the Secretary must reduce the national
unadjusted copayment amount for a covered OPD service (or group of such
services) furnished in a year in a manner so that the effective
copayment rate (determined on a national unadjusted basis) for that
service in the year does not exceed a specified percentage. As
specified in section 1833(t)(8)(C)(ii)(V) of the Act, the effective
copayment rate for a covered OPD service paid under the OPPS in CY
2006, and in calendar years thereafter, shall not exceed 40 percent of
the APC payment rate.
Section 1833(t)(3)(B)(ii) of the Act provides that, for a covered
OPD service (or group of such services) furnished in a year, the
national unadjusted copayment amount cannot be less than 20 percent of
the OPD fee schedule amount. However, section 1833(t)(8)(C)(i) of the
Act limits the amount of beneficiary copayment that may be collected to
the amount of the inpatient deductible.
Section 4104 of the Affordable Care Act eliminated the Part B
coinsurance for preventive services furnished on and after January 1,
2011, that meet certain requirements, including flexible
sigmoidoscopies and screening colonscopies, and waived the Part B
deductible for screening colonoscopies that become diagnostic during
the procedure. Our discussion of the changes made by the Affordable
Care Act with regard to copayments for preventive services furnished on
and after January 1, 2011, may be found in section XII.B. of the CY
2011 OPPS/ASC final rule with comment period (75 FR 72013).
2. OPPS Copayment Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45113), we proposed to
determine copayment amounts for new and revised APCs using the same
methodology that we implemented beginning in CY 2004. (We refer readers
to the November 7, 2003 OPPS final rule with comment period (68 FR
63458).) In addition, we proposed to use the same standard rounding
principles that we have historically used in instances where the
application of our standard copayment methodology would result in a
copayment amount that is less than 20 percent and cannot be rounded,
under standard rounding principles, to 20 percent. (We refer readers to
the CY 2008 OPPS/ASC final rule with comment period (72 FR 66687) in
which we discuss our rationale for applying these rounding principles.)
The national unadjusted copayment amounts for services payable under
the OPPS that will be effective January 1, 2013, are shown in Addenda A
and B to this final rule with comment period (which are available via
the Internet on the CMS Web site). As discussed in section XV. of this
final rule with comment period, for CY 2013, the Medicare beneficiary's
minimum unadjusted copayment and national unadjusted copayment for a
service to which a reduced national unadjusted payment rate applies
equals the product of the reporting ratio and the national unadjusted
copayment, or the product of the reporting ratio and the minimum
unadjusted copayment, respectively, for the service.
We note that APC copayments may increase or decrease each year
based on changes in the calculated APC payment rates due to updated
cost report and claims data, and any changes to the OPPS cost modeling
process. The CY 2013 proposed policy to base APC relative weights on
geometric mean costs would also affect the APC payment rates and,
through them, the corresponding beneficiary copayments. However, as
described in the CY 2004 OPPS/ASC final rule with comment period, the
development of the copayment methodology generally moves beneficiary
copayments closer to 20 percent of OPPS APC payments (68 FR 63458
through 63459). For a more detailed discussion of the final policy to
base the APC relative payment weights on geometric mean costs, we refer
readers to section II.A.2.f. of this final rule with comment period.
We did not receive any public comments regarding the proposed
methodology for calculating copayments for CY 2013. Therefore, for the
reasons set forth in the proposed rule (77 FR 45113), we are finalizing
our CY 2013 copayment methodology without modification.
3. Calculation of an Adjusted Copayment Amount for an APC Group
Individuals interested in calculating the national copayment
liability for a Medicare beneficiary for a given service provided by a
hospital that met or failed to meet its Hospital OQR Program
requirements should follow the formulas presented in the following
steps.
Step 1. Calculate the beneficiary payment percentage for the APC by
dividing the APC's national unadjusted copayment by its payment rate.
For example, using APC 0019, $67.28 is 20 percent of the full national
unadjusted payment rate of $336.38. For APCs with only a minimum
unadjusted copayment in Addenda A and B of this final rule with comment
period (which are available via the Internet on the CMS Web site), the
beneficiary payment percentage is 20 percent.
The formula below is a mathematical representation of Step 1 and
calculates national copayment as a percentage of national payment for a
given service.
B is the beneficiary payment percentage.
B = National unadjusted copayment for APC/national unadjusted payment
rate for APC
Step 2. Calculate the appropriate wage-adjusted payment rate for
the APC for the provider in question, as indicated in Steps 2 through 4
under section II.H. of this final rule with comment period. Calculate
the rural adjustment for eligible providers as indicated in Step 6
under section II.H. of this final rule with comment period.
Step 3. Multiply the percentage calculated in Step 1 by the payment
rate calculated in Step 2. The result is the wage-adjusted copayment
amount for the APC.
The formula below is a mathematical representation of Step 3 and
applies the beneficiary payment percentage to the adjusted payment rate
for a service calculated under section II.H. of this final rule with
comment period, with
[[Page 68300]]
and without the rural adjustment, to calculate the adjusted beneficiary
copayment for a given service.
Wage-adjusted copayment amount for the APC = Adjusted Medicare Payment
* B
Wage-adjusted copayment amount for the APC (SCH or EACH) = (Adjusted
Medicare Payment * 1.071) * B
Step 4. For a hospital that failed to meet its Hospital OQR Program
requirements, multiply the copayment calculated in Step 3 by the
reporting ratio of 0.980.
The unadjusted copayments for services payable under the OPPS that
will be effective January 1, 2013, are shown in Addenda A and B to this
final rule with comment period (which are available via the Internet on
the CMS Web site). We note that the national unadjusted payment rates
and copayment rates shown in Addenda A and B to this final rule with
comment period reflect the full CY 2013 OPD fee schedule increase
factor discussed in section II.B. of this final rule with comment
period.
Also, as noted above, section 1833(t)(8)(C)(i) of the Act limits
the amount of beneficiary copayment that may be collected to the amount
of the inpatient deductible.
III. OPPS Ambulatory Payment Classification (APC) Group Policies
A. OPPS Treatment of New CPT and Level II HCPCS Codes
CPT and Level II HCPCS codes are used to report procedures,
services, items, and supplies under the hospital OPPS. Specifically,
CMS recognizes the following codes on OPPS claims:
Category I CPT codes, which describe surgical procedures
and medical services;
Category III CPT codes, which describe new and emerging
technologies, services, and procedures; and
Level II HCPCS codes, which are used primarily to identify
products, supplies, temporary procedures, and services not described by
CPT codes.
CPT codes are established by the American Medical Association (AMA)
and the Level II HCPCS codes are established by the CMS HCPCS
Workgroup. These codes are updated and changed throughout the year. CPT
and HCPCS code changes that affect the OPPS are published both through
the annual rulemaking cycle and through the OPPS quarterly update
Change Requests (CRs). CMS releases new Level II HCPCS codes to the
public or recognizes the release of new CPT codes by the AMA and makes
these codes effective (that is, the codes can be reported on Medicare
claims) outside of the formal rulemaking process via OPPS quarterly
update CRs. This quarterly process offers hospitals access to codes
that may more accurately describe items or services furnished and/or
provides payment or more accurate payment for these items or services
in a timelier manner than if CMS waited for the annual rulemaking
process. We solicit public comments on these new codes and finalize our
proposals related to these codes through our annual rulemaking process.
As we proposed in the CY 2013 OPPS/ASC proposed (77 FR 45114), in Table
10 below (Table 13 of the proposed rule), we summarize our process for
updating codes through our OPPS quarterly update CRs, seeking public
comments, and finalizing their treatment under the OPPS. We note that
because the payment rates associated with codes effective July 1 were
not available to us in time for incorporation into the Addenda of the
proposed rule, the Level II HCPCS codes and the Category III CPT codes
implemented through the July 2012 OPPS quarterly update CR were not
included in Addendum B of the proposed rule (which is available via the
Internet on the CMS Web site), while those codes based upon the April
2012 OPPS quarterly update were included in Addendum B. Nevertheless,
we requested public comments on the codes included in the July 2012
OPPS quarterly update and included these codes in the preamble of the
proposed rule.
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[[Page 68301]]
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This process is discussed in detail below. We have separated our
discussion into two sections based on whether we solicited public
comments in the CY 2013 OPPS/ASC proposed rule or whether we are
soliciting public comments in this CY 2013 OPPS/ASC final rule with
comment period. We note that we sought public comments in the CY 2012
OPPS/ASC final rule with comment period on the new CPT and Level II
HCPCS codes that were effective January 1, 2012. We also sought public
comments in the CY 2012 OPPS/ASC final rule with comment period on the
new Level II HCPCS codes effective October 1, 2011. These new codes,
with an effective date of October 1, 2011, or January 1, 2012, were
flagged with comment indicator ``NI'' (New code, interim APC
assignment; comments will be accepted on the interim APC assignment for
the new code) in Addendum B to the CY 2012 OPPS/ASC final rule with
comment period to indicate that we were assigning them an interim
payment status and an APC and payment rate, if applicable, which were
subject to public comment following publication of the CY 2012 OPPS/ASC
final rule with comment period. We are responding to public comments
and finalizing our interim OPPS treatment of these codes in this CY
2013 OPPS/ASC final rule with comment period.
We received comments on several new codes that were assigned to
comment indicator ``NI'' in Addendum B of the CY 2012 OPPS/ASC final
rule with comment period. We respond to those comments in sections
II.A., III.D., V.B., and IX of this final rule with comment period.
Table 11 below lists the long descriptors for the CPT codes that were
assigned to comment indicator ``NI'' for which we received public
comments to the CY 2012 OPPS/ASC final rule with comment period and the
specific sections where the comments are addressed.
[[Page 68302]]
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1. Treatment of New CY 2012 Level II HCPCS and CPT Codes Effective
April 1, 2012 and July 1, 2012 for Which We Solicited Public Comments
in the CY 2013 OPPS/ASC Proposed Rule
Through the April 2012 OPPS quarterly update CR (Transmittal 2418,
Change Request 7748, dated March 2, 2012) and the July 2012 OPPS
quarterly update CR (Transmittal 2483, Change Request 7847, dated June
8, 2012), we recognized several new HCPCS codes for separate payment
under the OPPS. Effective April 1 and July 1 of CY 2012, we made
effective 13 new Level II HCPCS codes and 7 Category III CPT codes.
Specifically, 5 new Level II HCPCS codes were effective for the April
2012 update and another 8 new Level II HCPCS codes were effective for
the July 2012 update for a total of 13. Seven new Category III CPT
codes were effective for the July 2012 update. Of the 13 new Level II
HCPCS codes, we recognized for separate payment 11 of these codes, and
of the 7 new Category III CPT codes, we recognized for separate payment
all 7 new Category III CPT codes, for a total of 18 new Level II HCPCS
and Category III CPT codes that are recognized for separate payment for
CY 2013.
Through the April 2012 OPPS quarterly update CR, we allowed
separate payment for each of the five new Level II HCPCS codes.
Specifically, as displayed in Table 12 below, we provided separate
payment for HCPCS codes C9288, C9289, C9290, C9291 and C9733.
[[Page 68305]]
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In the CY 2013 OPPS/ASC proposed rule (77 FR 45115), we solicited
public comments on the proposed status indicators and APC assignments
for Level II HCPCS codes C9288, C9289, C9290, C9291, and C9733, which
were listed in Table 14 of the proposed rule (77 FR 45115) and now
appear in Tables 12 and 13 of this final rule with comment period.
We did not receive any public comments on the proposed APC
assignments and status indicators for HCPCS codes C9288, C9289, C9290,
and C9291. However, we received several public comments on HCPCS code
C9733, which are addressed in section III.D.7.a. of this final rule
with comment period.
For CY 2013, the HCPCS Workgroup replaced HCPCS codes C9288, C9289,
and C9291 (which was replaced with HCPCS code Q2046, effective July 1,
2012) with permanent HCPCS J-codes. Table 13 below list the replacement
HCPCS J-codes for the temporary HCPCS C-codes. Consistent with our
general policy of using permanent HCPCS codes rather than using
temporary HCPCS codes for the reporting of drugs under the OPPS in
order to streamline coding, we are showing the replacement HCPCS codes
C9288, C9289, and C9291/Q2046, effective January 1, 2013, in Table 13.
In this final rule with comment period, we are assigning the Level
II HCPCS codes listed in Table 13 below to the specific APCs and status
indicators for CY 2013.
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[[Page 68306]]
For CY 2013, we note that we are not making any changes to the
status indicators and APC assignments for HCPCS code C9290 and C9733.
That is, HCPCS code C9290 will continue its pass-through status and
will also continue to be assigned to APC 9290 for CY 2013. Similarly,
HCPCS code C9733 will continue to be assigned to status indicator
``Q2'' and also will continue to be assigned to APC 0397 for CY 2013.
Furthermore, because HCPCS code J9019 describes the same drug and
the same dosage currently designated by HCPCS code C9289, this drug
will continue its pass-through status in CY 2013. Therefore, we are
assigning HCPCS code J9019 to the same status indicator and APC as its
predecessor HCPCS code, as shown in Table 13.
However, we note that the replacement code for HCPCS code C9291,
which was replaced with HCPCS code Q2046 effective July 1, 2012, did
not describe the same dosage descriptor, and consequently, the
replacement HCPCS code was assigned a new APC number. Specifically,
HCPCS code Q2046, which has a dosage descriptor of 1 mg, was assigned
to APC 1420 effective July 1, 2012. Because the predecessor HCPCS code
C9291 was assigned to pass-through status, HCPCS code Q2046 also was
assigned to pass-through status for CY 2013. Similarly, the replacement
code for HCPCS code C9288 does not describe the same dosage descriptor,
and, consequently, its replacement HCPCS code J0716 was assigned a new
APC. Specifically, HCPCS code C9288 has a dosage descriptor of 1 vial;
however, its replacement HCPCS code J0716 has a dosage descriptor of
``up to 120 milligrams.'' Therefore, effective January 1, 2013, HCPCS
codes J0716 is assigned to APC 1431, a different APC, to maintain data
consistency for future rulemaking. Because the predecessor HCPCS code
C9288 was assigned to pass-through status, HCPCS code J0716 will
continue to be assigned status indicator ``G'' for CY 2013.
As discussed in the CY 2013 OPPS/ASC proposed rule (77 FR 45115
through 45116), through the July 2012 OPPS quarterly update CR, which
included HCPCS codes that were made effective July 1, 2012, we allowed
separate payment for 6 of the 8 new Level II HCPCS codes. Specifically,
as displayed in Table 14 below (also Table 14 of the proposed rule), we
provided separate OPPS payment for HCPCS codes C9368, C9369, Q2045,
Q2046, Q2048, and Q2049.
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We note that three of the Level II HCPCS Q-codes that were made
effective July 1, 2012, were previously described by HCPCS J-codes or
C-codes that were separately payable under the hospital OPPS. First,
HCPCS code Q2045 replaced HCPCS code J1680 (Injection, human fibrinogen
concentrate, 100 mg), beginning July 1, 2012. HCPCS code J1680 was
assigned to status indicator ``K'' (Nonpass-through drugs and
nonimplantable biologicals, including therapeutic radiopharmaceuticals;
paid under OPPS; separate APC payment) on
[[Page 68307]]
January 1, 2012. However, because HCPCS code J1680 was replaced by
HCPCS code Q2045 effective July 1, 2012, we changed its status
indicator to ``E'' (Not Payable by Medicare) effective July 1, 2012.
Because HCPCS code Q2045 describes the same drug as HCPCS code J1680,
we continued its separate payment status and assigned it to status
indicator ``K'' effective July 1, 2012. However, because the dosage
descriptor for HCPCS code Q2045 is not the same as HCPCS code J1680, we
assigned HCPCS code Q2045 to a new APC to maintain data consistency for
future rulemaking. Specifically, HCPCS code Q2045 was assigned to APC
1414 effective July 1, 2012.
Second, HCPCS code Q2046 replaced HCPCS code C9291 effective July
1, 2012. HCPCS code C9291 was assigned pass-through status when it was
effective April 1, 2012. Because HCPCS code Q2046 describes the same
product as HCPCS code C9291, we continued its pass-through status and
assigned HCPCS code Q2046 to status indicator ``G'' as well as assigned
it to the same APC, specifically APC 9291, effective July 1, 2012.
HCPCS code C9291 was deleted on June 30, 2012.
Third, the HCPCS Workgroup replaced HCPCS code J9001 (Injection,
doxorubicin hydrochloride, all lipid formulations, 10 mg) with new
HCPCS code Q2048, effective July 1, 2012. Consequently, the status
indicator for HCPCS code J9001 was changed to ``E'' (Not Payable by
Medicare) effective July 1, 2012. Because HCPCS code Q2048 describes
the same drug as HCPCS code J9001, we continued its separate payment
status and assigned HCPCS code Q2048 to status indicator ``K''
effective July 1, 2012. In addition, because, HCPCS code Q2049 is
similar to HCPCS code Q2048, we assigned HCPCS code Q2049 to status
indicator ``K'' effective July 1, 2012.
Of the 15 HCPCS codes that were effective July 1, 2012, we did not
recognize for separate OPPS payment two HCPCS codes because they are
both paid under a payment system other than OPPS. Specifically, HCPCS
code Q2047 was assigned to status indicator ``A'' (Not paid under OPPS;
paid by fiscal intermediaries/MACs under a fee schedule or payment
system other than OPPS), and HCPCS code Q2034 was assigned to status
indicator ``L'' (Not paid under OPPS; paid at reasonable cost).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45116), we solicited
public comments on the proposed status indicators and APC assignments
for the HCPCS codes that were listed in Table 15 of the proposed rule
and now appear in Table 14 and 15 of this final rule with comment
period.
We did not receive any other public comments on the new Level II
HCPCS codes that were implemented in July 2012. We are adopting as
final, without modification, our proposal to assign the Level II HCPCS
codes listed in Table 15 to the APCs and status indicators as proposed
for CY 2013.
Table 15 below includes a complete list of the Level II HCPCS codes
that were made effective July 1, 2012, with their final status
indicators and APC assignments for CY 2013.
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We note that the HCPCS Workgroup replaced HCPCS codes C9368, C9369,
Q2045, Q2046, Q2047, and Q2048 with HCPCS codes Q4132, Q4133, J7178,
J0178, J0890, and J9002, respectively, effective January 1, 2013.
Because
[[Page 68308]]
HCPCS codes Q4132, Q4133, and J0178 describe the same products
currently designated by HCPCS codes C9368, C9369, and Q2046,
respectively, these products will continue their pass-through status in
CY 2013. Therefore, we are assigning HCPCS codes Q4132, Q4133 and J0178
to the same status indicators and APCs as their predecessor HCPCS
codes, which share the same dosage descriptors, as shown in Table 15.
We note that because HCPCS codes Q2045 and Q2048 are assigned to status
indicator ``K'' (Nonpass-Through Drugs; Paid under OPPS; Separate APC
payment), their replacement HCPCS codes J7178 and J9002, which share
the same code descriptors as their predecessor codes, also will
continue their nonpass-through status and APC assignments in CY 2013.
Finally, HCPCS code Q2047 will be replaced with HCPCS code J0890
effective January 1, 2013. Because HCPCS code J0890 describes the same
product currently designated by HCPCS code Q2047, this product will
continue to be assigned to the same status indicator as its predecessor
HCPCS code, as shown in Table 15.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45116), we proposed to
continue our established policy of recognizing Category I CPT vaccine
codes for which FDA approval is imminent and Category III CPT codes
that the AMA releases in January of each year for implementation in
July through the OPPS quarterly update process. Under the OPPS,
Category I CPT vaccine codes and Category III CPT codes that are
released on the AMA Web site in January are made effective in July of
the same year through the July quarterly update CR, consistent with the
AMA's implementation date for the codes. For the July 2012 update,
there were no new Category I CPT vaccine codes. Through the July 2012
OPPS quarterly update CR (Transmittal 2483, Change Request 7847, dated
June 8, 2012), we allowed separate OPPS payment for all seven new
Category III CPT codes effective July 1, 2012. Specifically, as
displayed in Table 16 of the proposed rule and in Table 16 below, we
allowed separate payment for Category III CPT codes 0302T, 0303T,
0304T, 0305T, 0306T, 0307T, and 0308T.
We received one public comment on one of the Category III CPT codes
that were implemented in July 2012, specifically on CPT code 0304T,
which is addressed in section II.A.2.d.(1) of this final rule with
comment period. Table 16 below lists the Category III CPT codes that
were implemented in July 2012, along with their final status indicators
and APC assignments, for CY 2013. The final payment rates for these
codes can be found in Addendum B to this CY 2013 OPPS/ASC final rule
with comment period (which is available via the Internet on the CMS Web
site).
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In the CY 2013 OPPS/ASC proposed rule (77 FR 45114 through 45117),
we solicited public comments on the CY 2013 proposed status indicators
and the proposed APC assignments and payment rates for the Level II
HCPCS codes and the Category III CPT codes that were effective April 1,
2012, and July 1, 2012, through the respective OPPS quarterly update
CRs. These codes were listed in Tables 14, 15, and 16 of the proposed
rule. We proposed to finalize their status indicators and their APC
assignments and payment rates, if applicable, in this CY 2013 OPPS/ASC
final rule with comment period. Because the new Category III CPT and
Level II HCPCS codes that become effective for July are not available
to us in time for incorporation into the Addenda to the OPPS/ASC
proposed rule, our policy is to include the codes, their proposed
status indicators,
[[Page 68310]]
proposed APCs (where applicable), and proposed payment rates (where
applicable) in the preamble of the proposed rule but not in the Addenda
to the proposed rule. These codes were listed in Tables 15 and 16,
respectively, of the proposed rule. We proposed to incorporate these
codes into Addendum B to this CY 2013 OPPS/ASC final rule with comment
period, which is consistent with our annual OPPS update policy. The
Level II HCPCS codes implemented or modified through the April 2012
OPPS update CR and displayed in Table 14 were included in Addendum B to
the proposed rule (which was available via the Internet on the CMS Web
site), where their proposed CY 2013 payment rates were also shown.
We did not receive any additional public comments on this process.
The final status indicators, APC assignments, and payment rates if
applicable, for the Level II HCPCS codes and the Category III CPT codes
that were implemented or modified through the April 2012 or July 2012
OPPS update CR are found in Addendum B to this final rule with comment
period (which is available via the Internet on the CMS Web site).
2. Process for New Level II HCPCS Codes That Will Be Effective October
1, 2012 and New CPT and Level II HCPCS Codes That Will Be Effective
January 1, 2013 for Which We Are Soliciting Public Comments in This CY
2013 OPPS/ASC Final Rule With Comment Period
As has been our practice in the past, we incorporate those new
Category I and III CPT codes and new Level II HCPCS codes that are
effective January 1 in the final rule with comment period updating the
OPPS for the following calendar year. These codes are released to the
public via the CMS HCPCS (for Level II HCPCS codes) and AMA Web sites
(for CPT codes), and also through the January OPPS quarterly update
CRs. In the past, we also have released new Level II HCPCS codes that
are effective October 1 through the October OPPS quarterly update CRs
and incorporated these new codes in the final rule with comment period
updating the OPPS for the following calendar year. For CY 2013, these
codes are flagged with comment indicator ``NI'' in Addendum B to the
OPPS/ASC final rule with comment period to indicate that we are
assigning them an interim payment status which is subject to public
comment. In addition, the CPT and Level II HCPCS codes that will be
effective January 1, 2013, are flagged with comment indicator ``NI'' in
Addendum B to the OPPS/ASC final rule with comment period.
Specifically, the status indicator and the APC assignment and payment
rate, if applicable, for all such codes flagged with comment indicator
``NI'' are open to public comment in the final rule with comment
period, and we respond to these comments in the OPPS/ASC final rule
with comment period for the next calendar year's OPPS/ASC update. In
the CY 2013 OPPS/ASC proposed rule (77 FR 45117 through 45118), we
proposed to continue this process for CY 2013. Specifically, for CY
2013, we proposed to include in Addendum B to this CY 2013 OPPS/ASC
final rule with comment period the new Category I and III CPT codes
effective January 1, 2013 (including the Category III CPT codes that
were released by the AMA in July 2012) that would be incorporated in
the January 2013 OPPS quarterly update CR and the new Level II HCPCS
codes, effective October 1, 2012, or January 1, 2013, that would be
released by CMS in its October 2012 and January 2013 OPPS quarterly
update CRs. As proposed, in this final rule with comment period, the
October 1, 2012 and January 1, 2013 codes are flagged with comment
indicator ``NI'' in Addendum B to this CY 2013 OPPS/ASC final rule with
comment period to indicate that we have assigned them an interim OPPS
payment status for CY 2013. As proposed, in this final rule with
comment period, their status indicators and their APC assignments and
payment rates, if applicable, are open to public comment and will be
finalized in the CY 2014 OPPS/ASC final rule with comment period.
We did not receive any public comments on our proposal. Therefore,
we are finalizing our proposal to flag new Level II HCPCS codes that
become effective October 1, 2012, and new CPT and Level II HCPCS codes
that become effective January 1, 2013 with comment indicator ``NI'' in
Addendum B to this CY 2013 OPPS/ASC final rule with comment period to
indicate that these codes have been assigned an interim OPPS payment
status for CY 2013. In addition, because these codes have been assigned
to comment indicator ``NI,'' their status indicators and their APC
assignments and payment rates, if applicable, are open to public
comment and will be finalized in the CY 2014 OPPS/ASC final rule with
comment period.
B. OPPS Changes--Variations Within APCs
1. Background
Section 1833(t)(2)(A) of the Act requires the Secretary to develop
a classification system for covered hospital outpatient department
services. Section 1833(t)(2)(B) of the Act provides that the Secretary
may establish groups of covered OPD services within this classification
system, so that services classified within each group are comparable
clinically and with respect to the use of resources. In accordance with
these provisions, we developed a grouping classification system,
referred to as Ambulatory Payment Classifications (APCs), as set forth
in Sec. 419.31 of the regulations. We use Level I and Level II HCPCS
codes to identify and group the services within each APC. The APCs are
organized such that each group is homogeneous both clinically and in
terms of resource use. Using this classification system, we have
established distinct groups of similar services. We have also developed
separate APC groups for certain medical devices, drugs, biologicals,
therapeutic radiopharmaceuticals, and brachytherapy devices.
We have packaged into payment for each procedure or service within
an APC group the costs associated with those items or services that are
directly related to, and supportive of, performing the main independent
procedures or furnishing the services. Therefore, we do not make
separate payment for these packaged items or services. For example,
packaged items and services include:
(a) Use of an operating, treatment, or procedure room;
(b) Use of a recovery room;
(c) Observation services;
(d) Anesthesia;
(e) Medical/surgical supplies;
(f) Pharmaceuticals (other than those for which separate payment
may be allowed under the provisions discussed in section V. of the
proposed rule and this final rule with comment period);
(g) Incidental services such as venipuncture;
(h) Guidance services, image processing services, intraoperative
services, imaging, supervision and interpretation services, diagnostic
radiopharmaceuticals, and contrast media.
Further discussion of packaged services is included in section
II.A.3. of this final rule with comment period.
In CY 2008, we implemented composite APCs to provide a single
payment for groups of services that are
[[Page 68311]]
typically performed together during a single clinical encounter and
that result in the provision of a complete service (72 FR 66650 through
66652). Under CY 2012 OPPS policy, we provide composite APC payment for
certain extended assessment and management services, low dose rate
(LDR) prostate brachytherapy, cardiac electrophysiologic evaluation and
ablation, mental health services, multiple imaging services, and
cardiac resynchronization therapy services. Further discussion of
composite APCs is included in section II.A.2.e. of this final rule with
comment period.
Under the OPPS, we generally pay for hospital outpatient services
on a rate-per-service basis, where the service may be reported with one
or more HCPCS codes. Payment varies according to the APC group to which
the independent service or combination of services is assigned. Each
APC weight represents the hospital cost of the services included in
that APC, relative to the hospital cost of the services included in APC
0606 (Level 3 Hospital Clinic Visits). The APC weights are scaled to
APC 0606 because it is the middle level hospital clinic visit APC (the
Level 3 hospital clinic visit CPT code out of five levels), and because
middle level hospital clinic visits are among the most frequently
furnished services in the hospital outpatient setting.
Section 1833(t)(9)(A) of the Act requires the Secretary to review,
on a recurring basis occurring no less than annually, and revise the
groups, the relative payment weights, and the wage and other
adjustments to take into account changes in medical practice, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors. Section 1833(t)(9)(A) of the Act also
requires the Secretary to consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
review (and advise the Secretary concerning) the clinical integrity of
the APC groups and the relative payment weights (the HOP Panel
recommendations for specific services for the CY 2013 OPPS and our
responses to them are discussed in the relevant specific sections
throughout this final rule with comment period).
Finally, section 1833(t)(2) of the Act provides that, subject to
certain exceptions, the items and services within an APC group cannot
be considered comparable with respect to the use of resources if the
highest cost for an item or service in the group is more than 2 times
greater than the lowest cost for an item or service within the same
group (referred to as the ``2 times rule''). In the CY 2013 OPPS/ASC
proposed rule (77 FR 45118), for CY 2013, we proposed to use the cost
of the item or service in implementing this provision, as discussed in
section II.A.2.f. of this final rule with comment period. The statute
authorizes the Secretary to make exceptions to the 2 times rule in
unusual cases, such as low-volume items and services (but the Secretary
may not make such an exception in the case of a drug or biological that
has been designated as an orphan drug under section 526 of the Federal
Food, Drug, and Cosmetic Act).
2. Application of the 2 Times Rule
In accordance with section 1833(t)(2) of the Act and Sec. 419.31
of the regulations, we annually review the items and services within an
APC group to determine, with respect to comparability of the use of
resources, if the cost of the highest cost item or service within an
APC group is more than 2 times greater than the cost of the lowest cost
item or service within that same group. In making this determination,
we consider only those HCPCS codes that are significant based on the
number of claims. We note that, for purposes of identifying significant
HCPCS codes for examination in the 2 times rule, we consider codes that
have more than 1,000 single major claims or codes that have both
greater than 99 single major claims and contribute at least 2 percent
of the single major claims used to establish the APC cost to be
significant (75 FR 71832). This longstanding definition of when a HCPCS
code is significant for purposes of the 2 times rule was selected
because we believe that a subset of 1,000 claims is negligible within
the set of approximately 100 million single procedure or single session
claims we use for establishing costs. Similarly, a HCPCS code for which
there are fewer than 99 single bills and which comprises less than 2
percent of the single major claims within an APC will have a negligible
impact on the APC cost. In the CY 2013 OPPS/ASC proposed rule (77 FR
45118), we proposed to make exceptions to this limit on the variation
of costs within each APC group in unusual cases, such as low-volume
items and services, for CY 2013.
In the CY 2013 OPPS/ASC proposed rule, we identified APCs with 2
times rule violations but for which we proposed changes to their HCPCS
codes' APC assignments in Addendum B to the proposed rule. We note that
Addendum B did not appear in the printed version of the Federal
Register as part of the CY 2013 OPPS/ASC proposed rule. Rather, it was
published and made available via the Internet on the CMS Web site at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. In these cases, to eliminate a 2
times rule violation or to improve clinical and resource homogeneity,
we proposed to reassign the codes to APCs that contain services that
are similar with regard to both their clinical and resource
characteristics. We also proposed to rename existing APCs or create new
clinical APCs to accommodate proposed HCPCS code reassignments. In many
cases, the proposed HCPCS code reassignments and associated APC
reconfigurations for CY 2013 included in the proposed rule were related
to changes in costs of services that were observed in the CY 2011
claims data newly available for CY 2013 ratesetting. We also proposed
changes to the status indicators for some codes that were not
specifically and separately discussed in the proposed rule. In these
cases, we proposed to change the status indicators for some codes
because we believe that another status indicator would more accurately
describe their payment status from an OPPS perspective based on the
policies that we proposed for CY 2013. Addendum B of the CY 2013 OPPS/
ASC proposed rule identified with a comment indicator ``CH'' those
HCPCS codes for which we proposed a change to the APC assignment or
status indicator as assigned in the April 2012 Addendum B Update
(available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html). In contrast, Addendum B of this final rule with comment
period (available via the Internet on the CMS Web site) identifies with
the ``CH'' comment indicator the final CY 2013 changes compared to the
codes' status as reflected in the October 2012 Addendum B update.
3. Exceptions to the 2 Times Rule
As discussed earlier, we may make exceptions to the 2 times limit
on the variation of costs within each APC group in unusual cases such
as low-volume items and services. Taking into account the APC changes
that we proposed for CY 2013, we reviewed all the APCs to determine
which APCs would not satisfy the 2 times rule. Then we used the
following criteria to decide whether to propose exceptions to the 2
times rule for affected APCs:
Resource homogeneity;
Clinical homogeneity;
Hospital outpatient setting utilization;
[[Page 68312]]
Frequency of service (volume); and
Opportunity for upcoding and code fragments.
For a detailed discussion of these criteria, we refer readers to
the April 7, 2000 OPPS final rule with comment period (65 FR 18457 and
18458).
Table 17 of the CY 2013 OPPS/ASC proposed rule listed 21 APCs that
we proposed to exempt from the 2 times rule for CY 2013 based on the
criteria cited above and based on claims data processed from January 1,
2011, through December 31, 2011.
We note that, for cases in which a recommendation by the HOP Panel
appears to result in or allow a violation of the 2 times rule, we
generally accept the Panel's recommendation because those
recommendations are based on explicit consideration of resource use,
clinical homogeneity, site of service, and the quality of the claims
data used to determine the APC payment rates.
For the CY 2013 OPPS/ASC proposed rule, we based the listed
exceptions to the 2 times rule on claims data for dates of service
between January 1, 2011, and December 31, 2011, that were processed
before January 1, 2011. For this final rule with comment period, we
used claims data for dates of service between January 1, 2011, and
December 31, 2011, that were processed on or before June 30, 2012 and
updated CCRs, if available. Thus, after considering the public comments
we received on the CY 2013 OPPS/ASC proposed rule and making changes to
APC assignments based on those comments, we analyzed the CY 2011 claims
data used for this final rule with comment period to identify the APCs
with 2 times rule violations. Based on the final CY 2011 claims data,
we found that there are 19 APCs with 2 times rule violations, a
cumulative decrease of 2 APCs compared to the proposed rule. We applied
the criteria as described earlier to identify the APCs that are
exceptions to the 2 times rule for CY 2013, and identified two
additional APCs that meet the criteria for exception to the 2 times
rule for this final rule with comment period:
APC 0148 (Level I Anal/Rectal Procedures)
APC 0254 (Level V ENT Procedures)
In addition, we also determined that four APCs no longer violated
the 2 times rule:
APC 0128 (Echocardiogram with Contrast)
APC 0173 (Level II Partial Hospitalization (4 or more
services) for CMHCs)
APC 0604 (Level 1 Hospital Clinic Visits)
APC 0655 (Insertion/Replacement/Conversion of a Permanent
Dual Chamber Pacemaker or Pacing)
As discussed in section III.D.1.f. of this final rule with comment
period, because of concerns raised regarding the 2 times rule violation
for echocardiography services, and after further analysis of our claims
data, we deleted APC 0128 and replaced it with two new APCs to correct
the 2 times rule violation. Specifically, APC 0128 has been replaced
with APC 0177 (Level I Echocardiogram with Contrast) and APC 0178
(Level II Echocardiogram with Contrast). We have not included in this
count those APCs where a 2 times rule violation is not a relevant
concept, such as APC 0375 (Ancillary Outpatient Services when Patient
Expires), with an APC cost set based on multiple procedure claims;
therefore, we have identified only final APCs, including those with
criteria-based costs, such as device-dependent APCs, with 2 times rule
violations.
Comment: Several commenters urged CMS to reassign HCPCS G0379
(Direct admission of patient for hospital observation care) from APC
0604 (Level 1 Hospital Clinic Visits) to APC 0608 (Level 5 Hospital
Clinic Visits). In particular, the commenters requested that CMS assign
HCPCS G0379 to the same APC as CPT code 99205 (Office or other
outpatient visit for the evaluation and management of a new patient
(Level 5)) when the Composite APC 8002 (Level I Extended Assessment &
Management Composite) criteria are not met. The commenters indicated
that the reassignment of HCPCS code G0379 to APC 0608 would be
appropriate because it would resolve the 2 times rule violation in APC
0604 and also align the resources with a high-level hospital visit when
the criteria for Composite APC 8002 are not met. The commenters
suggested that continuing to assign HCPCS code G0379 to APC 0604 would
result in continued underpayments to HOPDs when the services and claims
processing requirements for APC 8002 are not met for a direct referral.
The commenters further added that this same issue was discussed during
the February 2012 HOP Panel meeting, and that after the discussion, the
Panel recommended that CMS reassign HCPCS code G0379 from APC 0604 to
an appropriate APC. The commenters urged CMS to accept the Panel's
recommendation.
Response: Based on the recommendation of the HOP Panel at its
February 2012 meeting, we reviewed our claims data for HCPCS code
G0379. Our analyses revealed that the level of hospital resources used
to provide HCPCS code G0379 is about the same as for CPT code 99205. In
particular, our claims data show similar geometric mean costs for HCPCS
code G0379 and CPT code 99205. Specifically, our claims data show a
geometric mean cost of approximately $181 for HCPCS code G0379 based on
2,368 single claims (out of 3,975 total claims), and a geometric mean
cost of approximately $179 based on 95,017 single claims (out of
104,246 total claims) for CPT code 99205. Based on our review of the
claims data associated with HCPCS code G0379 and CPT code 99025, we
agree with the commenters that the reassignment of HCPCS code G0379 to
APC 0608 is appropriate. Because APC assignments are made based on
consideration of both hospital resources and clinical homogeneity, we
believe this reassignment improves the clinical homogeneity of APC 0608
and appropriately aligns the resource costs of HCPCS code G0379 to
those procedures assigned to APC 0608.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal with modification to reassign HCPCS
code G0379 from APC 0604 to APC 0608, which has a final CY 2013
geometric mean cost of approximately $181.
Comment: One commenter indicated that APC 0623 violates the 2 times
rule and requested that CMS review the costs associated with CPT code
36260 (Insertion of implantable intra-arterial infusion pump (eg, for
chemotherapy of liver)) and reassign the CPT code to a more appropriate
APC.
Response: Table 17 of the CY 2013 OPPS/ASC proposed rule listed 21
APCs that violated the 2 times rule for CY 2013. APC 0623 does not
appear in Table 17 and assignment of CPT code 36260 to APC 0623 does
not violate the 2 times rule. As stated above, in determining whether a
2 times rule violation exist in an APC, we consider only those HCPCS
codes that are significant based on the number of claims. For purposes
of identifying significant HCPCS codes for examination in the 2 times
rule, we consider codes that have more than 1,000 single major claims
or codes that have both greater than 99 single major claims and
contribute at least 2 percent of the single major claims used to
establish the APC cost to be significant (75 FR 71832). This
longstanding definition of when a HCPCS code is significant for
purposes of the 2 times rule was selected because we believe that a
subset of 1,000 claims is negligible within the set of approximately
100 million single procedure or single session claims we
[[Page 68313]]
use for establishing costs. Similarly, a HCPCS code for which there are
fewer than 99 single bills and which comprises less than 2 percent of
the single major claims within an APC will have a negligible impact on
the APC cost. For this CY 2013 OPPS/ASC final rule with comment period,
there are only 3 single claims for CPT code 36260 (each of the 3 total
claims). Because CPT code 36260 does not represent a significant HCPCS
code based on the number of claims, it does not violate the 2 times
rule.
After consideration of the public comments we received and our
review of the CY 2011 costs from hospital claims and cost report data
available for this final rule with comment period, we are finalizing
our proposals with some modifications. Specifically, we are finalizing
our exemption of 17 of the original APCs (that appeared in Table 17 of
the CY 2013 OPPS/ASC proposed rule with comment period and also appears
in Table 17 below) from the 2 times rule for CY 2013. We are removing
four APCs that no longer violated the 2 times rule and decreasing the
number of APC exceptions from 21 to 19 APCs, as described previously in
this section. Our final list of 19 APCs exempted from the 2 times rule
for CY 2013 is displayed in Table 17 below.
[GRAPHIC] [TIFF OMITTED] TR15NO12.029
C. New Technology APCs
1. Background
In the November 30, 2001 final rule (66 FR 59903), we finalized
changes to the time period a service was eligible for payment under a
New Technology APC. Beginning in CY 2002, we retain services within New
Technology APC groups until we gather sufficient claims data to enable
us to assign the service to an appropriate clinical APC. This policy
allows us to move a service from a New Technology APC in less than 2
years if sufficient data are available. It also allows us to retain a
service in a New Technology APC for more than 2 years if sufficient
data upon which to base a decision for reassignment have not been
collected.
We note that the cost bands for New Technology APCs range from $0
to $50 in increments of $10, from $50 to $100 in increments of $50,
from $100 to $2,000 in increments of $100, and from $2,000 to $10,000
in increments of $500. These cost bands identify the APCs to which new
technology procedures and services with estimated service costs that
fall within those cost bands are assigned under the OPPS. Payment for
each APC is made at the mid-point of the APC's assigned cost band. For
[[Page 68314]]
example, payment for New Technology APC 1507 (New Technology--Level VII
($500--$600)) is made at $550. Currently, there are 82 New Technology
APCs, ranging from the lowest cost band assigned to APC 1491 (New
Technology--Level IA ($0--$10)) through the highest cost band assigned
to APC 1574 (New Technology--Level XXXVII ($9,500--$10,000). In CY 2004
(68 FR 63416), we last restructured the New Technology APCs to make the
cost intervals more consistent across payment levels and refined the
cost bands for these APCs to retain two parallel sets of New Technology
APCs, one set with a status indicator of ``S'' (Significant Procedure,
Not Discounted When Multiple) and the other set with a status indicator
of ``T'' (Significant Procedure, Multiple Reduction Applies). These
current New Technology APC configurations allow us to price new
technology services more appropriately and consistently.
Every year we receive many requests for higher payment amounts
under our New Technology APCs for specific procedures under the OPPS
because they require the use of expensive equipment. We are taking this
opportunity to reiterate our response in general to the issue of
hospitals' capital expenditures as they relate to the OPPS and
Medicare.
Under the OPPS, one of our goals is to make payments that are
appropriate for the services that are necessary for the treatment of
Medicare beneficiaries. The OPPS, like other Medicare payment systems,
is budget neutral and increases are limited to the annual hospital
inpatient market basket increase. We believe that our payment rates
generally reflect the costs that are associated with providing care to
Medicare beneficiaries in cost-efficient settings, and we believe that
our rates are adequate to ensure access to services.
For many emerging technologies, there is a transitional period
during which utilization may be low, often because providers are first
learning about the techniques and their clinical utility. Quite often,
parties request that Medicare make higher payment amounts under our New
Technology APCs for new procedures in that transitional phase. These
requests, and their accompanying estimates for expected total patient
utilization, often reflect very low rates of patient use of expensive
equipment, resulting in high per use costs for which requesters believe
Medicare should make full payment. Medicare does not, and we believe
should not, assume responsibility for more than its share of the costs
of procedures based on projected utilization for Medicare beneficiaries
and does not set its payment rates based on initial projections of low
utilization for services that require expensive capital equipment. For
the OPPS, we rely on hospitals to make informed business decisions
regarding the acquisition of high cost capital equipment, taking into
consideration their knowledge about their entire patient base (Medicare
beneficiaries included) and an understanding of Medicare's and other
payers' payment policies.
We note that, in a budget neutral environment, payments may not
fully cover hospitals' costs in a particular circumstance, including
those for the purchase and maintenance of capital equipment. We rely on
hospitals to make their decisions regarding the acquisition of high
cost equipment with the understanding that the Medicare program must be
careful to establish its initial payment rates, including those made
through New Technology APCs, for new services that lack hospital claims
data based on realistic utilization projections for all such services
delivered in cost-efficient hospital outpatient settings. As the OPPS
acquires claims data regarding hospital costs associated with new
procedures, we regularly examine the claims data and any available new
information regarding the clinical aspects of new procedures to confirm
that our OPPS payments remain appropriate for procedures as they
transition into mainstream medical practice.
2. Movement of Procedures From New Technology APCs to Clinical APCs
As we explained in the November 30, 2001 final rule (66 FR 59902),
we generally keep a procedure in the New Technology APC to which it is
initially assigned until we have collected sufficient data to enable us
to move the procedure to a clinically appropriate APC. However, in
cases where we find that our original New Technology APC assignment was
based on inaccurate or inadequate information (although it was the best
information available at the time), or where the New Technology APCs
are restructured, we may, based on more recent resource utilization
information (including claims data) or the availability of refined New
Technology APC cost bands, reassign the procedure or service to a
different New Technology APC that most appropriately reflects its cost.
Consistent with our current policy, in the CY 2013 OPPS/ASC
proposed rule (77 FR 45120), for CY 2013, we proposed to retain
services within New Technology APC groups until we gather sufficient
claims data to enable us to assign the service to a clinically
appropriate APC. The flexibility associated with this policy allows us
to move a service from a New Technology APC in less than 2 years if
sufficient claims data are available. It also allows us to retain a
service in a New Technology APC for more than 2 years if sufficient
claims data upon which to base a decision for reassignment have not
been collected. Table 18 of the proposed rule listed the HCPCS codes
and associated status indicators that we proposed to reassign from a
New Technology APC to a clinically appropriate APC or to a different
New Technology APC for CY 2013.
In the CY 2013 OPPS/ASC proposed rule, we noted that currently, in
CY 2012, there are three procedures described by HCPCS G-codes
receiving payment through a New Technology APC(77 FR 45121).
Specifically, HCPCS code G0417 (Surgical pathology, gross and
microscopic examination for prostate needle saturation biopsy sampling,
21-40 specimens) is assigned to New Technology APC 1505 (New
Technology--Level V ($300-$400)); HCPCS code G0418 (Surgical pathology,
gross and microscopic examination for prostate needle saturation biopsy
sampling, 41-60 specimens) is assigned to New Technology APC 1506 (New
Technology--Level VI ($400-$500)); and HCPCS code G0419 (Surgical
pathology, gross and microscopic examination for prostate needle
saturation biopsy sampling, greater than 60 specimens) is assigned to
New Technology APC 1508 (New Technology--Level VIII ($600-$700)). These
HCPCS codes have been assigned to New Technology APCs since CY 2009.
Analysis of the hospital outpatient data for claims submitted in
CYs 2009, 2010, and 2011 indicate that prostate needle saturation
biopsy procedures are rarely performed on Medicare beneficiaries. For
OPPS claims submitted from CY 2009 through CY 2011, our final rule
claims data show very minimal claims for HCPCS code G0417, G0418, and
G0419, as shown in Table 18.
[[Page 68315]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.030
Given the continued lack of cost data for these HCPCS codes, we
proposed to reassign these procedures to an APC that is appropriate
from a clinical standpoint (77 FR 45121). Specifically, we proposed to
reassign HCPCS G-codes G0417, G0418, and G0419 to clinical APC 0661
(Level V Pathology), with a proposed APC payment rate of approximately
$160 for CY 2013. We stated that we believe that all three procedures,
as described by HCPCS codes G0417, G0418, and G0419, are comparable
clinically to other pathology services currently assigned to APC 0661
and likely require similar resources. Table 18 of the proposed rule
listed the HCPCS G-codes and associated status indicators that we
proposed to reassign from New Technology APCs 1505, 1506, and 1508 to
APC 0661 for CY 2013.
We did not receive any public comments on the APC reassignments for
HCPCS codes G0417, G0418, and G0419. Therefore, for the reasons set
forth above, we are finalizing our proposal, without modification, to
assign these codes to APC 0661. We note that APC 0661 is the same APC
to which the other HCPCS G-code for prostate needle saturation biopsy
procedure, G0416 (Surgical pathology, gross and microscopic examination
for prostate needle saturation biopsy sampling, 1-20 specimens), is
assigned. In addition, for the CY 2013 update, we are revising the long
descriptor for HCPCS code G0416 to read ``Surgical pathology gross and
microscopic examination for prostate needle saturation biopsy sampling
10-20 specimens'' effective January 1, 2013. The final CY 2013
geometric mean cost for APC 0661 is approximately $162.
Table 19 below lists the HCPCS codes and associated status
indicators that we are reassigning from a New Technology APC to a
different New Technology APC for CY 2013. The final CY 2013 payment
rates for HCPCS codes G0417, G0418, and G0419 can be found in Addendum
B of this final rule with comment period (which is available via the
Internet on the CMS Web site).
[GRAPHIC] [TIFF OMITTED] TR15NO12.031
[[Page 68316]]
3. Payment Adjustment Policy for Radioisotopes Derived From Non-Highly
Enriched Uranium Sources
a. Background
Radioisotopes are widely used in modern medical imaging,
particularly for cardiac imaging and predominantly for the elderly
(Medicare) population. Technetium-99 (Tc-99m), the radioisotope used in
the majority of such diagnostic imaging services, is currently produced
in legacy reactors outside of the United States using highly enriched
uranium (HEU).
The Administration has established an agenda to eliminate domestic
reliance on these reactors, and is promoting the conversion of all
medical radioisotope production to non-HEU sources. Alternative methods
for producing Tc-99m without HEU are technologically and economically
viable, and conversion to such production has begun and is expected to
be completed within a 5-year time period. We expect this change in the
supply source for the radioisotope used for modern medical imaging will
introduce new costs into the payment system that are not accounted for
in the historical claims data.
Full Cost Recovery, which is routinely considered in CMS payment
under Medicare, is the accounting practice used by producers and
suppliers to describe the recovery of all contributing costs. Unlike
legacy sources that often benefit from government subsidized
multifunction facilities, the cost of these alternative methods will be
increased over the cost of medical radioisotopes produced using HEU
because hospitals' payments to producers and suppliers will have to
cover capital expense (such as, for example, the cost of building new
reactors, particle accelerators, or other very long-term investments),
as well as all other new industry-specific ancillary costs (such as,
for example, the cost of long-term storage of radioactive waste).
Hospitals that use medical radioisotopes that are produced from non-HEU
sources can expect producers and suppliers to pass on to them the full
impact of these costs.
In the short term, some hospitals will be able to depend on low
cost legacy producers using aging subsidized reactors while other
hospitals will be forced to absorb the full cost of non-HEU alternative
sources. Over several years, we believe that these cost differentials
will promote increased regional shortages and create larger cost
differentials and greater cost variations among hospitals. As a result,
we believe this change in supply source will create a significant
payment inequity among hospitals resulting from factors that are
outside of normal market forces.
b. Payment Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45121 through 45123),
we proposed to exercise our authority to establish ``other adjustments
as determined to be necessary to ensure equitable payments'' under the
OPPS in accordance with section 1833(t)(2)(E) of the Act. We stated
that we do not believe that we can ensure equitable payments to
hospitals over the next 4 to 5 years in the absence of an adjustment to
account for the significant payment inequities created by factors that
will likely arise due to the change in supply source for the
radioisotope used commonly in modern medical imaging procedures. We
proposed to provide an adjustment for the marginal cost for
radioisotopes produced from non-HEU sources over the costs for
radioisotopes produced by HEU sources. We stated that we believe such
an adjustment would ensure equitable payments in light of the
Administration's HEU agenda, market influences, cost differentials, and
cost variations that will create significant payment inequities among
hospitals.
For CY 2013, we proposed to make an additional payment of $10,
which is an amount based on the best available estimations of the
incremental costs associated with non-HEU Tc-99m production as
calculated using the Full Cost Recovery accounting methodology. We
proposed to establish a new HCPCS code, QXXXX (Tc-99m from non-HEU
source, full cost recovery add-on, per dose), to describe the Tc-99m
radioisotope produced by non-HEU methods and used in a diagnostic
procedure. Under the proposal, hospitals would be able to report this
HCPCS Q-code once per dose along with any diagnostic scan or scans
furnished using Tc-99m as long as the Tc-99m doses used can be
certified by the hospital as coming from non-HEU sources and have been
priced using a Full Cost Recovery accounting methodology. The HCPCS Q-
code would be used to pay hospitals for the additional (incremental)
cost of using Tc-99m from a non-HEU source.
Under the proposal, hospitals would not be required to make a
separate certification of the non-HEU source on the claim; the
inclusion of the new HCPCS code QXXXX on the claim would indicate that
the hospital has met the conditions of the service definition as it
does for any billed service. However, in the event of an audit, we
stated that hospitals would be expected to be able to produce
documentation that the individual dose delivered to the patient was
completely produced from a non-HEU source. We proposed three ways in
which hospitals could accomplish this.
First, the hospital could produce documentation such as invoices or
patient dose labels or tracking sheets that indicated that the
patient's dose was completely produced from non-HEU sources and priced
based on Full Cost Recovery. In this first case, the supplier would be
expected to be able to trace a specific dose of Tc-99m to a completely
non-HEU batch. Current pharmacy recordkeeping is generally able to
trace all components of radiopharmaceuticals back to their source
production batches. A hospital would not be compliant with the HCPCS Q-
code definition if the documentation indicated the supplier produced a
mixed batch and labeled a fraction of the doses equal to the non-HEU
fraction in the batch.
Second, a hospital could produce documentation that the entire
batch of Tc-99m doses derives from non-HEU sources for a specified
period of time, for example, the time that a single non-HEU based
generator is in use. This approach would obviate the need for specific
dose tracking from a claims audit perspective, although that
information is typically required for other purposes. An attestation
from the generator supplier would be sufficient evidence for the
hospital, as would invoices that show that all doses of Tc-99m during a
specified period came from inherently non-HEU alternative sources.
Third, if the industry was to implement labeling of generators and/
or doses with labels attesting to 100 percent non-HEU sources priced
based on Full Cost Recovery, documentation of labeled isotope usage
using either the specific dose approach or the 100 percent hospital
usage approach could provide evidence of hospital compliance. The
hospital would be required to retain appropriate documentation within
the hospital (including pharmacy) records but would not need to keep
any specific documentation within the individual medical record. Also,
we would consider a dose to be priced based on Full Cost Recovery when
the supplier could attest that the supply chain adheres to usual
industry practices to account for Full Cost Recovery, specifically
including the capital cost of sustainable production and the
environmental cost of waste management.
To reduce the administrative overhead for hospitals, we proposed
not
[[Page 68317]]
to require hospitals to separately track additional costs for Tc-99m
doses from non-HEU sources, but to include the cost of the radioisotope
in the cost of the diagnostic radiopharmaceutical as usual, reporting
only a token $1 charge for the HCPCS code QXXXX line. Under the
proposal, we would continue to calculate the total costs of
radionuclide scans using claims data, and would periodically
recalculate the estimated incremental cost of Tc-99m from non-HEU
sources based on Full Cost Recovery, using models relying on the best
available industry reports and projections, and would adjust the
payment for HCPCS code QXXXX accordingly, reducing the payment for the
scans by the amount of cost paid through HCPCS code QXXXX payment. We
stated that we believe this proposal allows us to continuously
compensate for unanticipated changes in Tc-99m cost attributable to new
non-HEU supply sources while avoiding a double payment for the
increased cost.
Comment: The vast majority of commenters conceptually agreed with
CMS' proposed payment policy. However, the commenters differed in
opinion on how CMS should implement a proposal to encourage hospitals
to switch from Tc-99m derived from HEU sources to Tc-99m derived from
non-HEU sources.
Many commenters disagreed specifically with CMS' proposal to make
an additional payment of $10 per dose for Tc-99m radioisotopes produced
by non-HEU methods, used in a diagnostic procedure. These commenters
agreed that an additional payment is necessary in order to ensure that
hospitals are fully paid for the additional costs incurred for the use
of non-HEU Tc-99m radioisotopes, but the commenters argued that the
additional $10 payment is insufficient and inadequate to incentivize
hospitals to change their current practices and transition purchases of
Tc-99m to non-HEU sources. The commenters suggested that CMS instead
adjust or increase the payment amount to more adequately cover any
additional costs to providers.
One commenter asked that CMS conduct a study of the actual costs at
a time when non-HEU Tc-99m is actually available to hospitals, and
propose an adjustment that will better reflect both the marginal
additional costs of the non-HEU sources and the administrative and
compliance burden on hospitals.
Another commenter recommended that CMS establish HCPCS code QXXXX
(Tc-99m from non-HEU sources, full cost recovery add-on, per dose) and
make an interim payment of $10 per unit for CY 2013 and CY 2014. The
commenter further suggested that, beginning in CY 2015, CMS calculate
the cost of the service described by the recommended code based on the
standard CMS payment methodology because the calculations will be based
on charges for services furnished in CY 2013, and for CY 2015 and years
following, CMS will have estimated costs on which to base the
additional payment for the HCPCS Q-code. In addition, the commenter
recommended that CMS carefully track the phase-out of the HEU sources
and eliminate HCPCS code QXXXX once HEU is phased out of the market in
the United States.
Overall, most of the commenters encouraged CMS to continue to work
with pertinent stakeholders and providers in the industry on this
issue.
Response: We agree with the commenters that $10 is not a large
incentive payment to promote a conversion to non-HEU sources of Tc-99m.
However, we are concerned that many commenters have mischaracterized
this payment. We did not create an additional payment to promote the
Administration's initiative to eliminate domestic reliance on legacy
production processes producing Tc-99m from HEU, as that is outside the
scope of the OPPS. Rather, the industry has conveyed to us that this
conversion to non-HEU sources will occur in response to U.S. strategic
policy, but that cost considerations have created barriers to that
movement. One of the cost considerations is the fact that non-HEU
sourced Mo-99, the Tc-99m precursor, is expected to cost more than
current sources from legacy reactors, and this increased cost will
adversely impact hospitals. In evaluating that concern, we determined
that there is, in fact, a probability not only that costs will increase
but that those costs will not be passed on uniformly as the industry
converts. Therefore, we used our authority to ensure payment equity
among hospitals by proposing to create this additional payment to
address the incremental cost of obtaining Tc-99m from the new sources
of supply. Although commenters have opined that a larger payment would
be a better incentive to support non-HEU conversion, the purpose for
the additional payment is limited to mitigating any adverse impact of
existing payment policy and is based on the authority set forth at
section 1833(t)(2)(E) of the Act.
Most of the comments raising concerns about the inadequacy of the
additional payment suggested that we did not account for the
administrative costs involved in implementing this additional payment
at the hospital level, at the radiopharmacy level, and at the level of
the generator manufacturer. However, we note that previous discussions
with the industry indicated that the actual costs of conversion,
distinct from the administrative costs of billing, are confined to the
producer (reactor) and the processor and are passed down through the
supply chain from there. In our own analysis, we concurred with that
finding and calculated a payment that would readily cover the
additional cost of this change in supply as it is passed down the
supply chain. We do not believe that it promotes efficiency to add
administrative markup to this increased cost of a supply, especially
given that we believe that the administrative cost of adding a new
service into the billing system should be small at the hospital and the
pharmacy levels. Moreover, due to the small absolute difference in cost
between non-HEU and HEU sourced Tc-99m, we do not believe that
significant inequities would exist in hospital costs until a
significant amount of more expensive non-HEU Mo-99 enters the system,
at which point any administrative cost would be spread over a large
number of claims.
Finally, we agree with commenters who stated that this additional
payment should be updated as better data become available. We stated in
the proposed rule that we intend to look at the amount of the add-on
payment and potentially update it as better economic information
becomes available. Although we did not limit ourselves to the
methodology beyond a commitment to use the best available data, we also
did not propose using our usual OPPS methodologies to update the
payment. We had specifically advised hospitals that separate reporting
of the cost of Tc-99m from non-HEU sources was not required for several
reasons. First, a particular generator manufacturer could elect to
provide HEU and non-HEU generators at the same averaged cost, a method
that would enable the client hospitals to defray any overall cost
increase as non-HEU generators became randomly available. Because there
could still be an incremental cost differential incurred by doing
business with that manufacturer as compared with a purely non-HEU
manufacturer, our normal OPPS methods would show no incremental cost
and thus could not be used to mitigate a payment inequity. Second, we
noted that separate reporting of the costs of the two sources or the
calculation and reporting of a cost differential would significantly
increase the administrative burden on hospitals,
[[Page 68318]]
a burden of which we have been particularly mindful.
Comment: Several commenters asked that CMS provide separate payment
for all diagnostic radiopharmaceuticals, regardless of their per day
cost, as this policy would support conversion to non-HEU sources. A few
commenters recommended that CMS unpackage all radiopharmaceuticals that
meet the annual packaging threshold. They also suggested that CMS
unpackage all radiopharmaceuticals that use Tc-99m, regardless of their
per day cost. One commenter suggested that the proposed add-on payment
of $10 be made in addition to separate payment for the diagnostic
radiopharmaceutical.
The commenters emphasized their concern over increased costs of
conversion to 100 percent non-HEU for radioisotopes. One commenter
argued that separate payment would provide a direct, measurable
incentive to the entire radiopharmaceutical market supply chain to
support the efforts to convert from HEU to non-HEU sources.
Additionally, the commenter stated that separate payment would allow
CMS to obtain accurate hospital cost data on the cost of both HEU and
non-HEU radiopharmaceuticals.
Response: We have already discussed in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66765 through 66768) the reasons why
the agency has determined that it is appropriate to package payment for
a diagnostic radiopharmaceutical into the payment for the nuclear
medicine scan, and we have finalized this policy again in section
II.A.3.f. of this final rule with comment period. However, specifically
from the standpoint of this add-on payment to ensure equitable payments
to hospitals, a separate payment for the diagnostic radiopharmaceutical
would not unpackage the cost of the radioisotope from the much larger
cost of the drug component, nor would it differentiate between HEU and
non-HEU sources. Therefore, unpackaging the cost of the diagnostic
radiopharmaceutical would not create a differential payment to ensure
payment equity amongst hospitals.
Comment: Several commenters were concerned with CMS' proposal that
Tc-99m doses be derived 100 percent from non-HEU sources in order to
receive the additional $10 payment. A few commenters stated that it
would be impossible to accurately predict the percentage of Tc-99m
doses that will be comprised 100 percent from non-HEU sources. Other
commenters expressed concern over the significant costs that will be
incurred for segregating 100 percent non-HEU sources, especially in the
radiopharmacy.
Response: We agree with the commenters that it will be impossible
to accurately predict the percentage of Tc-99m doses that will be
comprised of 100 percent of non-HEU sourced material, but that is
because it will be impossible to predict the percentage of non-HEU Tc-
99m available to manufacturers at any point in time. This presumption
is one of the reasons that led us to the conclusion that payment for
doses where 100 percent comes from non-HEU sources was the only
reasonable option. We do not need to predict the amount of non-HEU Mo-
99 available to the industry to establish a blend; instead, the HCPCS
Q-code can be used whenever and wherever enough non-HEU Tc-99m is
available to be kept separate down to the level of the generator or
patient dose. Multiple codes to reflect different blends are not
needed, and we do not need to create smaller payments for blends that
reflect smaller amounts of non-HEU material. Because payment must be
driven by cost, a 20-percent blend would be limited to 20 percent of
the $10 cost or $2, and hospitals are already concerned that the $10
additional payment is a small payment when they consider it against the
effort involved in making tracking and billing changes.
However, we do not believe that any costs created by changes in
radiopharmacy procedures will be significant in the charges passed on
to hospitals. We do understand that there may be some instances in
which a radiopharmacy will have both a non-HEU and an HEU generator,
and the pharmacy will need to determine whether it wants to keep those
sources separate or blend them and eschew labeling of a non-HEU source.
We also understand that this may be a larger issue at the generator
manufacturer level, especially very early in the conversion when non-
HEU Mo-99 is scarce. On the other hand, when non-HEU Mo-99 is scarce,
the incremental cost of higher priced non-HEU Mo-99 is small and the
blending of small amounts of non-HEU Mo-99 will not create payment
inequities among hospitals. We expect that as conversion progresses and
more non-HEU Mo-99 enters the supply chain, manufacturing processes may
evolve. Ultimately, there is no requirement to use this HCPCS Q-code or
label non-HEU based Mo-99; the payment exists as a tool if it is
necessary to reduce payment inequities that might occur as a
consequence of industry conversion to non-HEU based Mo-99.
One of the concerns about reporting doses derived from 100 percent
non-HEU sources had to do with compliance concerns if, in the process
of switching between an HEU and a non-HEU run, the manufacturer or
pharmacy did not add in an extra step of flushing lines to ensure that
cross-contamination did not occur. Our understanding is that using
different sources for consecutive manufacturing runs would not create
source contamination of more than 1 or 2 percent based on usual
manufacturing processes. We note that it is not our intent to introduce
unnecessary inefficiencies solely to support payment, and in this case
we can confirm that production steps, such as cleaning lines, should be
driven by FDA manufacturing requirements, not by payment
artificialities. We believe that manufacturing steps that do not risk
reducing the non-HEU sourced Mo-99 or Tc-99m to less than 95 percent of
the generator, elution or dose (that is, do not risk reducing the
content of the dose supplied to the patient to less than 95 percent
non-HEU sourced Tc-99m) are consistent with a product that is
completely derived from a non-HEU source. Therefore, we are modifying
our proposal to state that any dose of Tc-99m that can be traced to a
Mo-99 supply containing no more than 5 percent HEU sourced Mo-99 shall
be considered to be completely derived from non-HEU sources for the
purposes of this final rule with comment period, this additional
payment, and any compliance practices that support it. It is our
understanding that the normal manufacturing records will still support
processes that created the non-HEU supply.
Comment: One commenter expressed concern regarding the
administrative and financial burden that hospitals may incur upon
adoption of this proposed policy. The commenter stated that these
burdens may exceed the marginal additional cost of moving to non-HEU
sources. The commenter believed that the proposed policy would result
in additional administration and documentation burdens which include
the following additional expenses: expenses for developing and
maintaining policies to track, certify, and document HEU versus non-HEU
sources in order to use the newly required HCPCS Q-code; new compliance
program checks and monitoring to ensure the appropriate codes are used
and documentation is maintained should an audit be conducted;
additional personnel time and resources to create and maintain line
items on the hospital charge master for non-HEU versus HEU codes and
charges; and additional resources to
[[Page 68319]]
develop nuclear medicine department information technology
infrastructure, as well as billing policies for documentation and use
of the new HCPCS Q-code.
Another commenter also believed that this proposal would create a
significant burden on hospitals by requiring them to obtain, document,
and track information from the supplier and thereby create an
unnecessary level of complexity for hospitals that could result in code
errors and omissions on claims. The commenter urged CMS not to finalize
this proposal.
Response: We do not believe that this additional payment will
result in a significant administrative burden to hospitals. We note
that most hospitals have computerized inventory and billing systems
that are able to track low-cost items such as needles and aspirins. We
have reiterated in our response to public comments in this final rule
with comment period that we expect hospitals requesting this additional
payment to be able to track a dose that has been labeled or claimed as
``non-HEU sourced'' and do not expect hospitals to audit the validity
of such claims made by their suppliers. We also note that the cost of
adding a new code to the hospital chargemaster is not large, and that a
hospital is not being subject to a significant payment inequity if the
cost of adding a new code to the chargemaster actually exceeds the
added cost of non-HEU sourced Tc99m to the hospital. Hospitals that are
not experiencing high volumes of significantly increased costs are not
obligated to use this additional payment as its use is entirely
optional.
Comment: One commenter asked that CMS confirm in this final rule
with comment period that hospitals will not be required to audit or
otherwise independently verify manufacturer or radiopharmacy
documentation that a dose/injection meets the standard of non-HEU
priced at Full Cost Recovery.
A few commenters expressed concern regarding the compliance and
liability burden that adopting this policy may place on hospitals.
These commenters stated that hospitals may be uncomfortable attesting
that the supplies they receive are from non-HEU sources when there is
no reliable guarantee that the products are from non-HEU sources.
Further, the commenters stated that they believe that the term
``attesting'' in the ASP model is significantly different from what
they believe is the original intent of this proposal. Therefore, the
commenters suggested that CMS clarify the adequate documentation
necessary to confirm that the provider obtained a dose that is 100
percent from non-HEU sources.
Response: We are aware that providers must exert considerable
effort to conscientiously perform their compliance responsibilities
over such a vast health care system, and we specifically attempted to
offer examples of acceptable compliance steps to alleviate that burden
in this instance. We acknowledge that the end product used by hospitals
is effectively homogenous, and there is no practical way for a hospital
to prove chemically that a supply purported to be derived from a non-
HEU source truly meets those requirements. On the other hand, the
radiopharmaceutical industry is a heavily regulated industry closely
monitored by the Food and Drug Administration, and it is our
understanding that if a supplier indicates that a source is non-HEU,
manufacturing records will be able to confirm that. We are confident
that claims by suppliers as to the source of the Tc-99m used can be
satisfactorily audited through usual manufacturing processes without
creating additional requirements for hospitals. We do not expect
hospitals to assay doses of drugs to ensure that they received what the
invoice claimed, and we do not expect any chemical or physical
verification here. It was our intent in the proposed rule to indicate
that providers are expected to exercise due diligence, and to ensure
that their claims are supported by internal records of some type, but
that facilities could accept any tracking mechanism by a supplier
(invoice, label, contract, among others) regarding a non-HEU source as
satisfactory proof for the purposes of the facility.
We also note that any use of the word ``attestation'' in the
proposed rule was meant only to indicate a formal statement by one
party to assure another party of the source and composition. We further
note that these were examples in the proposed rule rather than
requirements.
Comment: Several commenters asked that CMS publish the methodology
and data used to establish the additional payment amount of $10 for Tc-
99m derived from non-HEU sources.
Response: There are two data sources on which we relied. First, the
Organization for Economic Cooperation and Development--Nuclear Energy
Agency (OECD-NEA) has published several economic analyses of the world
market for Tc-99m, which are pertinent for the United States because,
at present, our entire supply comes from foreign sources. Although some
members of the industry have opined that these data are not accurate
because the data include little information from U.S. suppliers, the
fact remains that there is currently no supply available domestically.
Thus, while the data we used may not reflect all of the unique market
forces present in the domestic market, this data source provides the
best estimation of the costs of non-HEU sources compared to HEU sources
because the manufacturing steps are primarily performed overseas and
therefore reflect the global market. Nonetheless, as an additional data
source, we invited industry entities to submit additional information
regarding their manufacturing and supply costs, production levels, and
prices. However, given that the industry is small with limited numbers
of competitors at each level of the supply chain, most American
companies were reluctant to provide information and were insistent on
confidentiality (as protected by FOIA Exemption 4) to safeguard the
sensitive (business competitive) information that they did share.
Therefore, we accepted supplemental information from the industry and
pledged to maintain its confidentiality, and consequently are unable to
provide details of the additional information. We can disclose our
methodology and refer readers to the OECD-NEA models that form the
basis of our model, noting that the supplemental information submitted
to date has not significantly altered the conclusions drawn by the
OECD-NEA.
To estimate costs, we tracked costs through the entire supply
chain, using a building block approach to add the cost of each step
onto the steps that occurred before it. Because the OECD-NEA provided
ranges rather than point estimations, we used an averaging approach to
factor in the possible low cost, the possible high cost, and the most
likely ``expected'' cost. This is a common estimation technique used in
business when significant uncertainty exists. By avoiding optimistic
assumptions, we were able to model a payment that reflects not only the
likely costs but ones that would also be adequate to cover unexpected
costs in one or more of the manufacturing steps.
In response to the request to provide as much detail about our
methodology as possible, we are detailing that methodology here. We
used a supply chain model to accumulate costs through the Tc-99m supply
chain based on--
(Unit Cost of Supply/Production Efficiency) + Unit Production Cost
+ ((Fixed Production Costs + Overhead)/Units Produced) = Unit
Production Cost = Downstream Unit Cost of Supply.
In tracking units (efficiency), we allowed for product loss during
production and for product loss as a
[[Page 68320]]
function of time (decay). We applied this model across a supply chain
that consisted of--
Irradiator/Producer > Processor > Generator Manufacturer > Nuclear
Pharmacy > Hospital > Patient.
Using a Program Evaluation and Review Technique (PERT) 3-point
estimation applied to costs, we based the upper and lower bounds on the
OECD-NEA economic models for Full Cost Recovery (2011) and non-HEU
Conversion (2012), given that U.S. supply is based on the global
market. We then varied the expected value to model a range of outcomes.
Finally we calculated the incremental cost of process changes by
subtracting current costs. Almost all of the incremental costs of
switching to non-HEU sources occur in the irradiation and the
processing steps, with very little impact on generator assembly,
generator elution, or the preparation of the patient dose. We noted
that any artificial costs of tracking during conversion would not be
reflected in the final post-conversion costs of supply. Due to the wide
variation in cost projections, we rounded up to the nearest $5 as most
of the estimators could not be regarded as sufficiently precise to
justify a more precise value until actual cost data become available.
This methodology resulted in a projection that fully accounts for the
cost of conversion in almost all probable scenarios and that also
accounts for or significantly offsets the costs of Full Cost Recovery
under most combinations of assumptions. Therefore, the $10 value can be
expected to offset any payment inequities under most likely
combinations of cost changes within the Tc-99m supply chain.
Comment: One commenter stated that suppliers of Mo-99 are currently
working toward full conversion to non-HEU sources by 2015. However, the
commenter stated that it is estimated that only 10 percent of the Tc-
99m doses used in the United States could be produced from 100 percent
non-HEU sources in 2013. The commenter further believed that the
proposed policy will cause a substantial increase in material costs,
require duplicative effort in the preparation of radiopharmaceutical
doses, add additional administrative costs, increase the costs for non-
HEU products, and create a disincentive for hospitals that cannot
purchase non-HEU products as they would be unwilling to pay higher
prices for their nuclear pharmaceutical products when they are not
receiving any additional benefits.
The commenter instead suggested that these impacts can be reduced
by establishing a threshold amount of Mo-99 that must be used by a
generator manufacturer for CY 2013, based on information provided by
the OECD-NEA and other pertinent stakeholders. The commenter stated
that this amount could then be adjusted upward in later years. The
commenter further explained that, in order for a technetium generator
to be considered ``compliant'' with the requirements for the additional
payment, the manufacturer of that generator would need to certify to
providers that it used at least the established threshold amount of
non-HEU sourced Mo-99 in the production of its generators for CY 2013
and for subsequent quarters. In turn, the hospitals that purchased the
Tc-99m doses prepared by complaint manufactures would receive separate
payment during that specific period. The commenter stated that this
approach would require a downward adjustment to the proposed $10
additional payment to reflect the lower amount of non-HEU Mo-99.
Response: We acknowledge the desirability of a simplified payment
for non-HEU sourced material in the generators, and agree that the
proposed blended payment would be much easier to implement. However, we
note that we do not have the authority to create that type of payment.
Within the OPPS, we depend on reported costs, as calculated from claims
and cost report information, to set prospective payments. Our authority
to deviate from this system in this instance is based on the authority
of the Secretary to adjust payments if necessary to ensure payment
equity among hospitals. A payment adjustment based on industry-wide
thresholds would not create a payment differential among those
hospitals with predominantly higher cost non-HEU sources and those
hospitals with predominantly lower cost HEU sources. However, although
we lack the authority to create a special payment to cover rising costs
at the industry or manufacturer level, we note that the normal OPPS
payment mechanism does exactly that: as costs rise, those costs will be
passed on globally to hospitals and reflected in their charges adjusted
to costs and, therefore, ultimately reflected in the prospective
payments calculated by our usual methodology. This add-on payment
merely ensures equitable payments to hospitals through the transition
where non-HEU sources are not uniformly distributed, while our
established OPPS mechanisms will ensure that the total costs of new
sources are incorporated into final payments year by year. We also have
previously stated that we believe that costly changes in manufacturing
solely to facilitate a transitional payment are not likely to occur,
and that instead the payment can be expected to trigger small
administrative changes. We expect that expensive changes in industry
processes will not be driven by an interim payment but will occur only
when those changes will continue to be necessary or desirable after the
transition is complete.
Comment: A few commenters suggested that CMS, at a minimum, allow a
payment adjustment for lower percentages (less than 100 percent) of
non-HEU sources and institute a multiyear phase-in period. One
commenter suggested that CMS establish a ``threshold quotient'' of non-
HEU content in Tc-99m radiopharmaceuticals during CY 2013 and allow
partial payment of the $10 additional payment amount. The commenter
explained that this would require CMS to accept a given percentage
amount of non-HEU source content and pay a corresponding percentage of
the proposed $10 additional payment amount. The commenter gave the
example of a payment of $1.50 for Tc-99m sources that contain 15
percent non-HEU, as $1.50 is 15 percent of the $10 proposed additional
payment amount. The commenter also suggested that CMS could further
promote the conversion to 100 percent non-HEU sources by adopting
industry-wide targets for conversion, which would include conversion to
25 percent in CY 2013, 50 percent in CY 2014, 75 percent in CY 2015,
and 100 percent in CY 2016.
Another commenter suggested that a 10-percent industry threshold
program be considered for CY 2013 in lieu of the 100 percent non-HEU
sources proposed requirement. The commenter stated that a payment of no
less than $10 could be given for non-HEU documented doses and that this
would be more reflective of the short-term non-HEU Mo-99 supply.
Response: As noted above, our authority to establish this
additional payment is based on the necessity to ensure equitable
payments to hospitals, an authority that does not allow us to develop
payments to promote the conversion of the industry to non-HEU sources.
Therefore, our ability to create industry-wide payments is limited. We
considered using one or more thresholds ranging from 10 percent to 80
percent to pay for blended sources that were not derived entirely from
non-HEU sourced Mo-99, but determined that to be impractical for
several reasons. First, the use of multiple codes to describe different
mixtures of HEU and non-HEU
[[Page 68321]]
sourced Mo-99 is immeasurably more complex than a simple single all or
nothing coding choice, and many commenters were concerned about the
complexity of even our proposed coding schema. Second, any blend of HEU
and non-HEU sourced material will, as mentioned by the commenters, have
reduced additional costs in proportion to the percentage of the blend.
Because many commenters were concerned that $10 was small compared to
the administrative effort they believed might be involved, we did not
believe that a significantly smaller payment would be acceptable to
that level of the supply chain.
Comment: Several commenters suggested that CMS extend the $10
additional payment for non-HEU sources for at least 5 years. The
commenters stated that this period of time will be required to convert
fully to non-HEU sources. Another commenter requested clarification of
the proposed implementation date and methodology for calculating the
total costs of radionuclide scans using claims data and the periodic
recalculation of the estimated marginal cost of non-HEU Full Cost
Recovery sources using models relying on the best available industry
reports and projections, resulting in an adjustment in the payment of
the proposed HCPCS code QXXXX accordingly, reducing the payment for the
scans by the amount of cost paid through the HCPCS code QXXXX payment.
Response: Although we typically propose only the payments for the
subsequent calendar year except in the case of adjustments that need to
be phased in over multiple years, we did state our current expectations
of the state of the industry and our expectations of a probable need
for this additional payment over multiple years. We stated that our
current expectation is that the transition to non-HEU sourced Mo-99
will be completed within 4 to 5 years. Therefore, we expect there may
be a need to make differential payments for a period of 4 to 5 years.
We will reassess, and propose, on an annual basis, whether such an
adjustment under section 1833(t)(2)(E) of the Act continues to be
necessary and whether any changes to the adjustment are needed. Again,
our current expectation is that this additional payment will be needed
for the duration of the industry's conversion to alternative methods to
producing Tc-99m without HEU, which is expected to be completed within
4 to 5 years.
With respect to the request for clarification regarding future
adjustments of this proposed payment, we note that the payment is being
applied in addition to the standard procedure payment amount for
nuclear medicine scans, including the diagnostic radioisotope and
pharmaceutical, that is paid based on reported costs. As more non-HEU
sourced Mo-99 is used, the costs reported by hospitals will contain
costs associated with non-HEU conversion. Because the HCPCS code QXXXX
is the indicator of non-HEU Mo-99 use and is also the vehicle for the
additional payment, the rate at which extra payments are made will
exactly follow the rate at which non-HEU sources are reported with
their attendant additional costs. Therefore, even as we increase the
payment for the nuclear medicine scan with radioisotope in the future
due to increasing radioisotope costs, we expect to offset (reduce) the
payment by the amount of the non-HEU add-on payment to avoid paying
twice for non-HEU costs. This approach has the effect of using the add-
on payment to make an additional payment for the cost of non-HEU
sourced Mo-99 in the year that the cost appears, rather than waiting 18
months until the cost is reflected in the claims data. Consistent with
our OPPS methods, though, we will still be basing the final payments
for the nuclear medicine scans on the aggregate costs of the scan and
its radioisotopes and pharmaceuticals as reported by hospitals. For
example, suppose that 20 percent of hospitals in CY 2013 report non-HEU
Tc-99m usage billed with HCPCS code QXXXX. The OPPS payment for the
scan with its diagnostic radioisotope will still reflect 100 percent of
the reported CY 2011 costs. The $10 from HCPCS code QXXXX will
represent additional money because the higher cost non-HEU Tc-99m was
not reflected in the CY 2011 cost data. However, when we set the rates
for CY 2015, those 20 percent of the hospitals who used non-HEU Tc-99m
in CY 2013 will have reported higher costs for scans in the CY 2013
claims data because they had an additional cost from the non-HEU Tc-99m
that they used. To eliminate a double payment, we will need to make an
adjustment, such as removing the total dollars paid by HCPCS code QXXXX
in CY 2013 (that is, the estimated additional cost of the non-HEU
sourced isotope in those 20 percent of the claims) from the total
reported procedure dollars in CY 2013 before setting the base procedure
rate for CY 2015. We note that this offset does not reduce the payment
for the scan below its current level; it only keeps the payment from
going up as the cost of the radioisotope rises, because the increased
cost of the radioisotope is being paid separately using HCPCS code
QXXXX. In fact, in CY 2015, the utilization of non-HEU sourced Tc-99m
should have continued to climb well beyond 20 percent. As in CY 2013,
the dollars associated with increased utilization, that is, HCPCS code
QXXXX billing in excess of the 20 percent, will again represent
additional money over the total costs reflected in the CY 2013 claims.
Comment: A few commenters suggested that CMS alter the description
of the proposed HCPCS code QXXXX by adding the word ``study'' into the
descriptor in order to make this definition more consistent with the
arcana of the radiopharmaceutical industry. The commenters stated that
the descriptor for the HCPCS Q-code therefore would be HCPCS code QXXXX
(Tc-99m from non-HEU source, full cost recovery add-on, per study
dose). The commenters stated that it would be logical to add the word
``study'' because several nuclear cardiology procedures could require
multiple Tc-99m doses administered alone with one CPT procedure code.
Thus, they believed that providers would purchase one to three study
doses. The commenters further suggested that CMS clarify in this final
rule with comment period that the add-on payment would apply to each
per study dose of the complete service as described by the CPT
procedure code. Therefore, the commenters stated, providers would be
able to bill the HCPCS Q-code with multiple units and be paid $10 per
the number of study doses provided during the procedure described by
the CPT code, as appropriate.
Response: We acknowledge that it was our intent that this
additional payment would be applied per study dose, such as the dose
for the study performed at rest and the dose for the study performed
with exercise. Therefore, we accept these recommendations and are
modifying the proposed HCPCS definition to include the word ``study''
as follows: HCPCS code Q9969 (Tc-99m from non-highly enriched uranium
source, full cost recovery add-on, per study dose).
Comment: Several commenters requested that CMS clarify the proposal
which requires a reduction to the payment for the scans by the amount
of cost paid through the proposed HCPCS code QXXXX. The commenters were
not sure whether the payment offset would be applied uniformly to all
hospitals or only to those hospitals reporting non-HEU source doses.
The commenters further requested that no reduction in
[[Page 68322]]
payment for nuclear scans by made as a result of the additional $10
payment amount.
Response: Although commenters were not making this comment in the
context of budget neutrality, the considerations that caused us to
create a payment offset were driven by precisely that statutory
constraint. As discussed above, because hospitals will not be required
to separately report costs for non-HEU radioisotopes, all increased
costs will be reported as part of the charges for the nuclear scans. To
preserve budget neutrality, an additional payment in one place must be
accompanied by an offset somewhere else. To prevent double payment for
the radioisotope, this offset will have to come from the payment for
nuclear scans. Because all hospitals use the same codes for scans, and
because parallel families of codes for scans using HEU and non-HEU
sourced Tc-99m were not feasible, the offset will be applied to all
hospitals. However, this offset will not occur until the claims data
show non-HEU payments, at which time reported charges will presumably
also reflect these increases in radioisotope costs. Thus, under the
current expectations, if 10 percent of CY 2013 claims for a given
nuclear scan show a $10 non-HEU add-on payment, $1 (10 percent of $10)
will be offset in CY 2015 from the nuclear scan payment. However, if
the 10 percent of hospitals claiming the $10 add-on payment also had
$10 in increased costs, the calculated cost of a scan using CY 2013
data will have increased by $1 (10 percent of $10). The payment for CY
2015 would therefore increase by $1 because of the new costs in the
claims data, and that new $1 will then be removed (offset) to go
exclusively to the hospitals that are actually using the non-HEU
sourced Tc-99m and are carrying the added cost. Therefore, we note that
we are not reducing payments to all hospitals to offset the cost of
this payment; rather, we are ensuring that the added costs of the non-
HEU sourced Tc-99m go only to the hospitals incurring the costs and
that their payments are not diluted by increased payments to uninvolved
facilities. In this way, we are not offsetting the current nuclear scan
payment by the $10 non-HEU add-on payment even though we currently plan
to offset future payment increases to the extent necessary to avoid
double payments, as those increased costs will be included in the costs
reported by hospitals.
Comment: Several commenters suggested that CMS use the average
sales price (ASP) methodology to establish the additional payment
amount for Tc-99m based on non-HEU sources. One commenter suggested
that CMS use the ASP data when available as a benchmark for determining
costs that are packaged. A few commenters suggested that payment based
on the ASP methodology be applied in the same manner CMS pays for
therapeutic radiopharmaceuticals. The commenters stated that this will
establish transparency in the ratesetting for radioisotopes derived
from non-HEU sources.
Response: We note that the ASP methodology does not apply to the
Tc-99m radioisotope but only to the radiopharmaceutical that results
from the combination of the isotope with the pharmaceutical moiety.
Moreover, the ASP methodology is particularly unsuited to use on the
radioisotope component alone because the isotope does not have an ASP.
The radioisotope is typically produced by a generator and, whereas the
ASP of a generator can be determined, the cost of a single dose is
highly dependent on the number and timing of elutions of the generator,
information that is not captured in the ASP. In fact, ASP is marginally
valuable for Tc-99m radiopharmaceuticals only because the cost of the
drug component is typically large compared to the cost of the isotope.
This fact also argues against the comment that ASP would increase
``transparency'' of the cost of Tc-99m: There is no additional
transparency of an isotope packaged into a payment with the drug than
there is for an isotope packaged into a payment with the scan. Finally,
the use of the ASP methodology would not differentiate between the cost
of a non-HEU sourced Tc-99m and the cost of using an HEU source, which
is the purpose of this payment. The proposed additional payment
accounts for the increased cost of the isotope, which meets both
incremental payment and transparency goals.
Comment: A few commenters recommended that CMS establish parallel
codes for the use of HEU and non-HEU sourced radiopharmaceuticals to
collect cost data for future ratesetting. Most of the commenters were
concerned with the complexity involved in adding and reporting a single
code.
Response: We do not believe that an entire set of parallel codes
would lessen the complexity or the administrative cost and, in fact, we
believe it would significantly increase them. We acknowledge that this,
like many other options we have had on other issues, could
significantly improve the accuracy of our ratesetting. However, based
on other comments from the hospitals that would have to use these
parallel codes, we do not believe that we or the hospitals would
consider the increased administrative cost to be worth the slight
increase in payment precision.
Comment: A few commenters requested that CMS clarify the meaning of
``calculation by `Full Cost Recovery' ''. Some commenters also
requested clarification of what this method encompasses.
Response: Full Cost Recovery is a concept that is well known to the
producers, processors, and manufacturers but is not commonly discussed
by radiopharmacies and hospitals. Unlike other supplies, radioisotopes
typically require nuclear reactors for initial production, and many of
the capital and environmental costs are not captured in the prices. For
example, some reactors were built decades ago for other purposes and
can be used (relatively) ``free of charge'' because it costs almost the
same to run the reactor and do nothing as it does to run the reactor
and irradiate some uranium. This has implications on the accounting of
capital costs, which, in many cases, were or are recovered by other
uses to which the reactors were put. Similarly, moderately enriched
uranium left over from previous programs may be cheaply downgraded and
provided at a ``low'' cost because the alternative is to allow it to
decay in storage with no consequent benefit. In both cases, the Tc-99m
produced is obtained by hospitals at a bargain price, but not at a
price that is sustainable because the old reactors will need to be
replaced and the enriched uranium will be depleted. There are other
unique costs for radioisotopes, such as the need to make arrangements
for long-term storage of radioactive waste. Failure to account for
those costs can lower the price of the radioisotope for some hospitals
today but creates a long-term problem in that other hospitals must pick
up the costs. Full Cost Recovery is the accounting principle that
ensures that all of these long-term costs are included in cost
calculations.
Full Cost Recovery is obviously not important to the hospitals
although, because it is critically important in providing for the long-
term supply of the radioisotope, it is actually a major underlying
cause of payment inequities associated with this transition. From the
standpoint of this final rule with comment period then, Full Cost
Recovery is coupled to the non-HEU criterion for purposes of the
additional payment. Just as manufacturers will indicate that certain
Tc-99m doses are derived from non-HEU sources, it is our expectation
that the irradiator (reactor) and the processor of the non-HEU Mo-
[[Page 68323]]
99 will be able to confirm that Full Cost Recovery accounting was used
in setting the price of the non-HEU sourced Mo-99, an accounting
principle that is considered integral to the conversion to non-HEU
sources. We expect the generator manufacturer to affirm to the
radiopharmacy that its source is non-HEU, with this designation
including accounting according to Full Cost Recovery. As mentioned
earlier, we consider this affirmation to be sufficient for the
radiopharmacy and the hospital, regardless of whether the affirmation
is in the form of a letter or statement, a notation on the invoice, or
a label on the vial or tracking slip. We do not believe that
independent verification is necessary or even possible for the
radiopharmacy and the hospital and require only their due diligence in
accepting claims made by their suppliers. The costs of new capital
expenses such as new reactors, including all their associated costs,
are factored into the manufacturer's price of the Tc-99m and passed
down to hospitals, and the additional payment is made to account for
those unique costs that the hospitals will incur.
Comment: One commenter asked that CMS delay finalizing the proposal
until CY 2014 so that hospitals have adequate time to implement the
proposed change. Another commenter recommended that CMS postpone the
implementation of the proposed policy until CY 2015, so that hospitals
could avoid the complexities of handling and segregating HEU sources
versus non-HEU sources. Another commenter expressed doubt that
hospitals would be able to obtain Tc-99m derived from non-HEU sources
in CY 2013. Therefore, they requested that the proposal be deferred
until CY 2014.
One commenter expressed concern about the availability of non-HEU
sources because they were told by their suppliers that a 100 percent
non-HEU source supply is unavailable for CY 2012 and also will be
unavailable by CY 2013. The commenter questioned whether this issue
should be addressed by a payment system and suggested that this issue
instead be addressed by the Administration as opposed to CMS. The
commenter further suggested that the implementation of this proposal be
delayed until there is some availability of 100 percent non-HEU sourced
isotopes in this country.
Response: We considered the timing of this proposed additional
payment after advice and consultation from both the Mo-99 industry and
other U.S. agencies. We were initially advised that it is the
understanding of the industry that conversion to non-HEU sources is
already underway and is expected to be completed by the end of 2016. We
understand this remains the case. We are aware that currently
commercial Tc-99m is not readily available in the United States as it
is in the world market, but that there also has not been a demand from
within the United States. We do understand there is an expectation that
it will make an appearance in CY 2013.
We acknowledge that the supply of non-HEU sourced Mo-99 may be
small in CY 2013. However, we believe, as the industry believes, that
conversion to non-HEU sourced Tc-99m is inevitable and will occur over
the next several years. From the standpoint of the Medicare payment
system, it is important for us to have some mechanism in place to
mitigate any adverse impact on hospitals. If the supply is very low,
hospitals will not be significantly disadvantaged and may elect to not
make use of this additional payment in CY 2013. Conversely, if the
supply starts to increase, some hospitals may be forced to shoulder a
disproportionate share of the cost due to supplier relationships and
contract status; this additional payment will create an opportunity for
those hospitals to mitigate that cost. We fully expect that utilization
of this additional payment will be small in CY 2013 but will increase
in CYs 2014, 2015, and 2016 as this conversion occurs. We reiterate
that the normal mechanisms of the OPPS will ultimately incorporate
increased costs into APC calculations with resultant increased payments
for the nuclear scans that use this radioisotope that will allow us to
retire or modify this payment and incorporate the entire additional
cost into the base payment. This additional payment will enable
hospitals to avoid any inequities caused by suddenly rising local costs
that are not able to be captured in a timely fashion by usual methods.
Based on the timetable for conversion and the rescue nature of the
payment, we believe that a delay until CY 2014 or CY 2015 is
unnecessary.
Comment: Several commenters suggested that an additional separate
payment be given in other Medicare settings, including the physician's
office and ASC, for radioisotopes derived from non-HEU sources. One
commenter recommended that these additional payments also be made under
Medicaid, the Department of Defense/Veterans Affairs, Indian Health
Services health programs, and any other government health programs
where nuclear medicine procedures are covered. This commenter
acknowledged that its comments are outside the scope of the OPPS/ASC
final rule with comment period.
Response: We agree with the commenter that addressing additional
payments for radioisotopes derived from non-HEU sources in other
settings and payment systems, such as the Physician's Office, Medicaid,
the Department of Defense/Veterans Affairs, Indian Health Services
health programs, and any other government health programs where nuclear
medicine procedures are covered, is outside the scope of the proposed
rule and cannot be addressed in this final rule with comment period. In
addition, we note that the Medicare authority for this additional
payment is based on the need to establish equitable payments for
hospitals. The authority to make equitable adjustments under section
1833(t)(2)(E) of the Act does not extend to the ASC setting. We do use
a HCPCS Q-code as the vehicle for this additional payment so that other
payers and other payment systems could use this code if desired.
After consideration of the public comments we received, we are
finalizing our proposed policy with the modifications discussed above.
Specifically, we are modifying the policy to provide that a product
identified as non-HEU sourced must be at least 95 percent derived from
non-HEU sources. We also are finalizing our proposal to establish a
HCPCS code for Tc-99m from non-HEU sources with a revised code
definition. The number and title of the new HCPCS code is HCPCS code
Q9969 (Tc-99m from non-highly enriched uranium source, full cost
recovery add-on, per study dose) for CY 2013. HCPCS code Q9969 is
assigned to APC 1442 (Non-HEU TC-99M Add-On/Dose) with a status
indicator of ``K'' and a CY 2013 payment rate of $10.
D. OPPS APC-Specific Policies
1. Cardiovascular and Vascular Services
a. Cardiac Telemetry (APC 0213)
For CY 2013, we proposed to reassign CPT code 93229 (External
mobile cardiovascular telemetry with electrocardiographic recording,
concurrent computerized real time data analysis and greater than 24
hours of accessible ecg data storage (retrievable with query) with ecg
triggered and patient selected events transmitted to a remote attended
surveillance center for up to 30 days; technical support for connection
and patient instructions for use, attended surveillance, analysis and
physician prescribed transmission of daily and emergent data reports)
from APC 0209 (Level II Extended EEG,
[[Page 68324]]
Sleep, and Cardiovascular Studies), which had a proposed rule payment
rate of approximately $808, to APC 0340 (Minor Ancillary Procedures),
which had a proposed rule payment rate of approximately $49.
Comment: One commenter disagreed with CMS' proposal to reassign CPT
code 93229 to APC 0340 because the service described by CPT code 93229
involves the use of sophisticated technology requiring 24-hour, 7 days
a week monitoring by a technician for up to 30 days, which according to
the commenter, is not a minor procedure. According to the commenter,
the proposed rule payment rate of approximately $49 is significantly
lower than the MPFS payment rate of $694, and much lower than the
average contractual arrangement charge to hospitals of $674. The
commenter explained that while this procedure is performed primarily by
independent diagnostic testing facilities (approximately 98 percent),
this service is provided in the HOPD setting under contractual
arrangements with hospitals. The commenter stated that the CPT code is
fairly new because it was effective January 1, 2009, and suggested that
the low geometric mean cost for the service could be attributed to
miscoding by hospitals. The commenter believed that hospitals may be
reporting CPT code 93229 incorrectly when they are actually performing
other remote cardiac tests, such as the services described by CPT code
93226 (External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; scanning analysis with report)
or CPT code 93271 (External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording with symptom-
related memory loop with remote download capability up to 30 days, 24-
hour attended monitoring; transmission and analysis), that require
fewer resources. In addition, the commenter questioned the validity of
the claims data, given the low number of claims billed under the OPPS.
The commenter requested that CMS delay the reassignment of the service
described by CPT code 93229 to APC 0340, and urged CMS to maintain CPT
code 93229 in APC 0209 until more data are available to determine an
appropriate payment for the service.
Response: The commenter is correct that CPT code 93229 was
effective January 1, 2009. However, we believe that since that time
hospitals have familiarized themselves with how to code this service
appropriately. We have no reason to believe that hospitals are
incorrectly reporting the service described by CPT code 93229, and note
that we do not specify the methodologies that hospitals must use to set
charges for this, or any other, procedure. The calculation of OPPS
relative payment weights that reflect the relative resources required
for HOPD services is the foundation of the OPPS. We rely on hospitals
to bill all HCPCS codes accurately in accordance with their code
descriptors and CPT and CMS instructions, as applicable, and to report
charges on claims and charges and costs on their Medicare hospital cost
report appropriately.
We do not agree with the commenter that it is necessary to delay
the reassignment of CPT code 93229 to APC 0340. We examined our claims
data for the last 3 years, given the concerns raised by the commenter
regarding the low number of claims. Our analysis revealed that the
claims submitted for the service described by CPT code 93229 have
steadily increased since CY 2009, but the cost for the procedure has
been significantly lower than the APC payment rate. Specifically, the
cost for the service described by CPT code 93229 in CY 2009 was
approximately $287, based on 103 single claims (out of 114 total
claims), approximately $260 in CY 2010, based on 184 single claims (out
of 184 total claims), and approximately $172 for CY 2011, based on
1,949 single claims (out of 1,949 total claims). Based on the claims
data, we have no reason to believe that the claims data used to
calculate the cost for CPT code 93229 for CY 2013 does not
appropriately reflect the hospitals cost for providing this service.
In addition, because of concerns raised by the commenter regarding
reassigning CPT code 93229 to an APC that is labeled ``Minor Ancillary
Procedures,'' further review of our claims data for this final rule
with comment period showed that CPT code 93229 would be more
appropriately assigned to APC 0213 (Level I Extended EEG, Sleep, and
Cardiovascular Studies) than APC 0340 based on its clinical homogeneity
and resource costs in relation to the other procedures assigned to APC
0213. Our claims data show a geometric mean cost of approximately $172
for CPT code 93229, which is relatively similar to the final geometric
mean cost of approximately $178 for APC 0213.
Further, we recognize that the MPFS pays separately for CPT code
93229, but the MPFS and the OPPS are very different payment systems.
Each system is established under a different set of statutory and
regulatory principles, and the policies established under the MPFS do
not have bearing on the payment policies under the OPPS.
In summary, after consideration of the public comment we received,
we are finalizing our CY 2013 proposal, with modification.
Specifically, we are reassigning CPT code 93229 from APC 0209 to APC
0213 (instead of the proposed APC 0340) for CY 2013. The final CY 2013
geometric mean cost for APC 0213 is approximately $178.
b. Mechanical Thrombectomy (APC 0653)
For CY 2013, we proposed to continue to assign CPT code 36870
(Thrombectomy, percutaneous, arteriovenous fistula, autogenous or
nonautogenous graft (includes mechanical thrombus extraction and intra-
graft thrombolysis)) to APC 0653 (Level I Hand Musculoskeletal
Procedures), which had a proposed rule payment rate of approximately
$2,445.
Comment: Some commenters expressed concern regarding the proposed
19.7 percent reduction in the payment rate for the APC in which the
procedure describing a mechanical thrombectomy by arteriovenous access,
CPT code 36870, is assigned. The commenters believed that such a
reduction would impede Medicare beneficiary's access to the procedure.
In addition, the commenters stated that CMS offered no explanation for
the payment rate reduction, nor permitted adequate notice for a
meaningful opportunity to comment. The commenters requested that CMS
delay its proposal to reduce the payment rate for mechanical
thrombectomy by AV access until stakeholders have been given a
meaningful opportunity to comment.
Response: On an annual basis, CMS evaluates hospital outpatient
claims data to determine the cost of procedures and services paid under
the OPPS to ensure appropriate APC assignment for the following year.
This evaluation generally results in establishing new APCs, reassigning
procedures and services to more appropriate APCs, or deleting APCs that
are no longer applicable. In addition, this evaluation may result in
revising relative payment weights, as well as wage and other
adjustments, to take into account changes in medical practices, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors. The OPPS proposed rule is published
annually in the summer and is the mechanism used by CMS to inform the
public of the proposed changes for the upcoming year and provide an
opportunity for comment. As has been
[[Page 68325]]
our practice, we encourage the public to submit their comments on
issues addressed in the proposed rule. Comments received in response to
the proposed rule are addressed in the final rule with comment period,
which is also published annually in the winter.
For the CY 2013 update, our analysis of the latest hospital
outpatient data for claims submitted for services provided during CY
2011 shows a geometric mean cost for CPT code 36870 of approximately
$2,662, based on 539 single claims (out of 50,476 total claims), which
is relatively similar to the proposed rule payment rate of
approximately $2,748 for APC 0653. Based on our claims data, we believe
that APC 0653 is the most appropriate APC assignment for CPT code 36870
based on its clinical homogeneity and resource costs in relation to the
other procedures assigned to the APC. Consistent with our policy of
reviewing APC assignments annually, we will again reevaluate the cost
of CPT code 36870 and its APC assignment in CY 2013 for the CY 2014
rulemaking cycle.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal without modification. We will continue
to maintain CPT code 36870 in APC 0653 for CY 2013. The final CY 2013
geometric mean cost for APC 0653 is approximately $2,748.
c. Non-Congenital Cardiac Catheterization (APC 0080)
For CY 2011, the AMA's CPT Editorial Panel restructured the Cardiac
Catheterization section of the CPT codebook so that combinations of
services that were previously reported using multiple codes are now
reported with one CPT code. This revision deleted several non-
congenital cardiac catheterization-related CPT codes from the 93500
series and created new CPT codes in the 93400 series and in the 93500
series. We discussed these coding changes in detail in the CY 2011
OPPS/ASC final rule with comment period (75 FR 71846 through 71849),
along with the process by which we assigned the new CPT codes to APCs
that we believe are comparable with respect to clinical characteristics
and resources required to furnish the cardiac catheterization services
described by the new CPT codes. As discussed in that final rule with
comment period, we were able to use the existing CY 2009 hospital
outpatient claims data and the most recent cost report data to create
simulated costs for the new separately payable CPT codes for CY 2011.
Specifically, to estimate the hospital costs associated with the 20 new
non-congenital cardiac catheterization-related CPT codes based on their
CY 2011 descriptors, we used claims and cost report data from CY 2009.
Because of the substantive coding changes associated with the new non-
congenital cardiac catheterization-related CPT codes for CY 2011, we
used our CY 2009 single and ``pseudo'' single claims data to simulate
the new CY 2011 CPT code definitions. We stated that many of the new
CPT codes were previously reported using multiple CY 2009 CPT codes,
and we provided a crosswalk of the new CY 2011 cardiac catheterization
CPT codes mapped to the CY 2009 cardiac catheterization CPT codes in
Table 11 of the CY 2011 OPPS/ASC final rule with comment period (75 FR
71849). Table 11 showed the criteria we applied to select a claim to be
used in the calculation of the cost for the new codes (shown in Column
A). As we stated in the CY 2011 OPPS/ASC final rule with comment period
(75 FR 71847 through 71848), we developed these criteria based on our
clinicians' understanding of the services that were reported by the CY
2009 CPT codes that, in various combinations, reflect the services
provided that are described in the new CPT codes. We used approximately
175,000 claims for the new non-congenital catheterization-related CPT
codes, together with the single and ``pseudo'' single procedure claims
for the remaining non-congenital catheterization-related CPT codes in
APC 0080 (Diagnostic Cardiac Catheterization), to calculate CPT code
level costs and the payment rate for APC 0080 of approximately $2,698.
We noted that, because the CPT codes listed in Table 11 were new for CY
2011, they were identified with comment indicator ``NI'' in Addendum B
to that final rule with comment period to indicate that the interim APC
assignment was subject to public comment. We specifically requested
public comment on our methodology for simulating the costs for these
new CY 2011 CPT codes, in addition to public comments on the payment
rates themselves (75 FR 71848).
For CY 2012, we continued to use the CY 2011 methodology in
determining the APC assignments for the new cardiac catheterization CPT
codes. That is, we continued to use the CY 2011 methodology in
determining the APC assignments for the cardiac catheterization CPT
codes by using the existing hospital outpatient claims and the cost
report data from the predecessor cardiac catheterization CPT codes to
simulate an estimated cost for the new cardiac catheterization CPT
codes in determining the appropriate APC assignments. Specifically, we
used the CY 2010 hospital outpatient claims data and the most recent
cost report data to create simulated costs for the new separately
payable CPT codes for CY 2012 to determine the payment rates for the
APC to which the cardiac catheterization CPT codes were assigned. For
CY 2012, we did not make any changes to the CY 2011 APC assignments of
any of the CPT codes assigned to APC 0080 because the claims data
supported continuation of these APC assignments.
As we discussed in the CY 2013 OPPS/ASC proposed rule, because the
cardiac catheterization CPT codes were new for CY 2011, CY 2013 is the
first year that claims data are available for ratesetting for these
specific CPT codes (77 FR 45084 through 45085). For CY 2013, our
analysis of the CY 2011 claims data available for the proposed rule
showed no violation of the 2 times rule for the cardiac catheterization
CPT codes because the lowest cost of a CPT code with significant claims
data in APC 0080 was approximately $1,716 (for CPT code 93451), while
the highest cost of a CPT code with significant claims data was
approximately $3,308 (for CPT code 93461). We stated in the proposed
rule that we believe that the cardiac catheterization CPT codes
continue to be appropriately assigned to APC 0080 based on clinical
homogeneity and resource costs. Therefore, for CY 2013, we proposed to
continue to assign the cardiac catheterization CPT codes to APC 0080.
Comment: One commenter pointed out that CPT codes 93463
(Pharmacologic agent administration (eg, inhaled nitric oxide,
intravenous infusion of nitroprusside, dobutamine, milrinone, or other
agent) including assessing hemodynamic measurements before, during,
after and repeat pharmacologic agent administration, when performed
(list separately in addition to code for primary procedure)) and 93464
(Physiologic exercise study (eg, bicycle or arm ergometry) including
assessing hemodynamic measurements before and after (list separately in
addition to code for primary procedure)), which appeared in Table 5
(Proposed APCs to Which Non-Congenital Cardiac Catheterization CPT
Codes Would Be Assigned for CY 2013) of the CY 2013 OPPS/ASC proposed
rule do not appear to represent cardiac catheterization procedures.
Response: CPT codes 93463 and 93464 are packaged procedures. These
CPT codes appeared in Table 5 of the CY 2013 OPPS/ASC proposed rule
because these procedures are performed
[[Page 68326]]
in conjunction with cardiac catheterization procedures. CPT code 93463
is an add-on code that describes a pharmacologic agent that may be
administered when a cardiac catherization procedure is performed.
Similarly, CPT code 93464 is an add-on code that describes a
physiologic exercise test that may be combined with a cardiac
catheterization. Because these procedures are used in conjunction with
cardiac catherization procedures, we believe that listing them in Table
5 of the CY 2013 OPPS/ASC proposed rule was appropriate.
After consideration of the public comment that we received, we are
finalizing our proposal, without modification, to continue to assign
the cardiac catheterization CPT codes to APC 0080 for CY 2013, as
listed below in Table 20 below. The final CY 2013 geometric mean cost
for APC 0080 is approximately $2,726.
[GRAPHIC] [TIFF OMITTED] TR15NO12.032
d. Endovascular Revascularization of the Lower Extremity (APCs 0083,
0229, and 0319)
For the CY 2011 update, the AMA's CPT Editorial Panel created 16
new CPT codes under the Endovascular Revascularization section of the
2011 CPT codebook to describe endovascular revascularization procedures
of the lower extremity performed for occlusive disease. In the CY 2011
OPPS/ASC final rule with comment period (75 FR 71841 through 71845), we
discussed the process and methodology by which we assigned the CY 2011
endovascular revascularization CPT codes to APCs that we believe are
comparable with respect to clinical characteristics and resources
required to furnish the services. Specifically, we were able to use the
existing CY 2009 hospital outpatient claims data and the most recent
cost report data to create simulated costs for 12 of the 16 new
separately payable CPT codes for CY 2011. Because the endovascular
revascularization CPT codes were new for CY 2011, we used our CY 2009
single and ``pseudo'' single claims data to simulate the new CY 2011
CPT code definitions. As shown in Table 7 of the CY 2011 OPPS/ASC final
rule with comment period (75 FR 71844), many of the new endovascular
revascularization CPT codes were previously reported using a
combination of CY 2009 CPT codes. In order to simulate costs, we
selected claims that we believe met the definition for each of the new
endovascular revascularization CPT codes. Table 7 showed the criteria
we
[[Page 68327]]
applied to select a claim to be used in the calculation of the costs
for the new CPT codes (shown in Column A). As we stated in the CY 2011
OPPS/ASC final rule with comment period (75 FR 71842), we developed
these criteria based on our clinicians' understanding of services that
were reported by the CY 2009 CPT codes that, in various combinations,
reflect the services provided that are described by the new CPT codes
for CY 2011.
After determining the simulated costs for the procedures, we
assigned each CPT code to appropriate APCs based on their clinical
homogeneity and resource use. Of the 16 CPT new codes, we assigned 9
CPT codes to APC 0083 (Coronary or Non-Coronary Angioplasty and
Percutaneous Valvuloplasty) and 5 CPT codes to APC 0229 (Transcatheter
Placement of Intravascular Shunts), and created new APC 0319
(Endovascular Revascularization of the Lower Extremity) for the
remaining 2 CPT codes. Table 8 of the CY 2011 OPPS/ASC final rule with
comment period (75 FR 71845) displayed their final CY 2011 APC
assignments and CPT code costs. We noted that, because these CPT codes
were new for CY 2011, they were assigned comment indicator ``NI'' in
Addendum B to the CY 2011 OPPS/ASC final rule with comment period to
identify them as new interim APC assignments for CY 2011, and subject
to public comment. We specifically requested public comment on our
methodology for simulating the costs for these new CY 2011 CPT codes in
addition to public comments on the payment rates themselves (75 FR
71845).
As stated in the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74156), for CY 2012, we continued to use the CY 2011 methodology
to determine the APC assignments for the CPT codes that describe
endovascular revascularization of the lower extremity. Because previous
endovascular revascularization CPT codes were in existence prior to CY
2011 and assigned to designated APCs, we continued to use existing
hospital outpatient claims and cost report data from the established
CPT codes to simulate estimated costs for the endovascular
revascularization CPT codes to determine the appropriate APC
assignments for CY 2012, as we did for CY 2011. In the CY 2012 OPPS/ASC
final rule with comment period, we also revised the title of APC 0083
from ``Coronary or Non-Coronary Angioplasty and Percutaneous
Valvuloplasty'' to ``Coronary Angioplasty, Valvuloplasty, and Level I
Endovascular Revascularization of the Lower Extremity''; revised the
title of APC 0229 from ``Transcatheter Placement of Intravascular
Shunts and Stents'' to ``Level II Endovascular Revascularization of the
Lower Extremity''; and revised the title of APC 0319 from
``Endovascular Revascularization of the Lower Extremity'' to ``Level
III Endovascular Revascularization of the Lower Extremity''.
Because the endovascular revascularization of the lower extremity
CPT codes were new for CY 2011, CY 2013 is the first year of claims
data that are available for ratesetting for these specific CPT codes.
For CY 2013, review of the procedures with significant claims data in
APCs 0083, 0229, and 0319 did not show 2 times rule violations in these
APCs. In the CY 2013 OPPS/ASC proposed rule, we stated that we believe
that the endovascular revascularization CPT codes assigned to APCs
0083, 0229, and 0319 continue to be appropriately assigned based on
clinical homogeneity and resource costs. Therefore, we proposed to
continue to assign the endovascular revascularization CPT codes to APCs
0083, 0229, and 0319 for CY 2013 (77 FR 45083 through 45084).
Comment: Several commenters believed that the assignment of CPT
code 37183 (Revision of transvenous intrahepatic portosystemic shunt(s)
(tips) (includes venous access, hepatic and portal vein
catheterization, portography with hemodynamic evaluation, intrahepatic
tract recanulization/dilatation, stent placement and all associated
imaging guidance and documentation) and 37210 (Uterine fibroid
embolization (ufe, embolization of the uterine arteries to treat
uterine fibroids, leiomyomata), percutaneous approach inclusive of
vascular access, vessel selection, embolization, and all radiological
supervision and interpretation, intraprocedural roadmapping, and
imaging guidance necessary to complete the procedure) to APC 0229
(Level II Endovascular Revascularization of the Lower Extremity)
violated the 2 times rule. The commenter believed that these two codes
should be reassigned to APC 0083 (Coronary Angioplasty, Valvuloplasty,
and Level I Endovascular Revascularization of the Lower Extremity).
Response: As stated above, in determining whether a 2 times rule
violation exists in an APC, we consider only those HCPCS (both CPT and
Level II Alphanumeric HCPCS codes) codes that are significant based on
the number of claims. For purposes of identifying significant HCPCS
codes for examination to determine if they violate the 2 times rule, we
consider codes that have more than 1,000 single major claims or codes
that have both greater than 99 single major claims and contribute at
least 2 percent of the single major claims used to establish the APC
cost to be significant (75 FR 71832). This longstanding definition of
when a code is significant for purposes of the 2 times rule was
selected because we believe that a subset of 1,000 claims is negligible
within the set of approximately 100 million single procedure or single
session claims we use for establishing costs. Similarly, a code for
which there are fewer than 99 single claims and which comprises less
than 2 percent of the single major claims within an APC will have a
negligible impact on the APC cost.
For this CY 2013 OPPS/ASC final rule with comment period, our
analysis of the CY 2011 claims data showed that CPT code 37183 had 211
single claims (out of 302 total claims) while CPT code 37210 had 211
single claims (out of 254 total claims). Of the 12 procedures assigned
to APC 0229, only 5 procedures meet the definition of significant
claims. Specifically, CPT codes 37205 (Transcatheter placement of an
intravascular stent(s) (except coronary, carotid, vertebral, iliac, and
lower extremity arteries), percutaneous; initial vessel), 37221
(Revascularization, endovascular, open or percutaneous, iliac artery,
unilateral, initial vessel; with transluminal stent placement(s),
includes angioplasty within the same vessel, when performed), 37225
(Revascularization, endovascular, open or percutaneous, femoral,
popliteal artery(s), unilateral; with atherectomy, includes angioplasty
within the same vessel, when performed), 37226 (Revascularization,
endovascular, open or percutaneous, femoral, popliteal artery(s),
unilateral; with transluminal stent placement(s), includes angioplasty
within the same vessel, when performed), and 37229 (Revascularization,
endovascular, open or percutaneous, tibial, peroneal artery,
unilateral, initial vessel; with atherectomy, includes angioplasty
within the same vessel, when performed) have significant claims data to
determine whether a violating of the 2 times rule exists within APC
0229. Review of the procedures assigned to APC 0229 revealed that the
range of the CPT geometric mean costs for the procedures with
significant claims data is between approximately $7,013 (for CPT code
37205, which represents 14 percent of the single claims) and
approximately $9,915 (for CPT code
[[Page 68328]]
37229, which represents 5 percent of the single claims). Taking into
consideration all of the codes with significant claims that are
assigned to APC 0229, CPT codes 37183 and 37210 do not meet the
definition of significant claims to determine if there is a violation
of the 2 times rule within APC 0229.
Therefore, based on the clinical similarity to other procedures
currently assigned to APC 0229, and because there is no determination
of a violation of the 2 times rule, we are continuing to assign CPT
codes 37183 and 37210 to APC 0229 for CY 2013. For CY 2013, APC 0229
has a final geometric mean cost of approximately $8,905.
Comment: Several commenters recommended the reassignment of add-on
CPT code 37223 (Revascularization, endovascular, open or percutaneous,
iliac artery, each additional ipsilateral iliac vessel; with
transluminal stent placement(s), includes angioplasty within the same
vessel, when performed (list separately in addition to code for primary
procedure)) from APC 0083 to APC 0229 because the proposed geometric
mean cost of the procedure is similar to the geometric mean costs of
procedures assigned to APC 0229 (although the commenters also pointed
out that the cost data calculated from single claims for CPT code 37223
are unreliable because CPT code 37223 is an add-on code and would not
appear by itself on a claim). Some commenters also argued that the
assignment of CPT code 37223 to APC 0083 results in a violation of the
2 times rule. The commenters stated that the reassignment of CPT code
37223 to APC 0229 would be consistent with CMS' policy of assigning
add-on codes to the same APC as their base codes. In addition, the
commenters asserted that this reassignment would not only ensure
patient access for this therapeutic procedure, but also would promote
clinical homogeneity and similar resource cost of procedures assigned
to APC 0229 and provide accurate payment for the procedure.
Response: Although there are many add-on codes that have been
assigned to the same APC as their base code, there are some procedures
that are add-on codes that have been assigned to different APCs from
their base or primary codes. In establishing an appropriate APC
assignment, we take into consideration the clinical homogeneity and
similarity in resource use associated with the procedure or service.
This determination may result in the same APC assignment for both the
base code and the add-on code, or in different APC assignments, as
illustrated in Table 21 below. Therefore, we disagree with the
commenters' assertion that we should reassign CPT code 37223 to APC
0229 so that it is in the same APC as its base code.
We also do not agree with commenters that the composition of APC
0083 constitutes a violation of the 2 times rule because CPT code 37223
does not have sufficient single claims to qualify as a significant
procedure for purposes of applying the 2 times rule, as described
earlier in this section. Based on our understanding of the procedure,
we continue to believe that APC 0083 is the most appropriate assignment
for CPT code 37223 based on clinical considerations and similarity in
resource use to other procedures assigned to APC 0083, as we have
stated in the past (76 FR 74156).
[GRAPHIC] [TIFF OMITTED] TR15NO12.033
Further, in response to the commenters' concerns regarding
providing accurate payment for the procedure described by CPT code
37223 to ensure patient access, we believe that the payment rate for
the procedure does not inhibit HOPDs from performing the procedure. The
OPPS, like other Medicare payment systems, is budget neutral and
overall increases in payments are limited to the hospital inpatient
market basket increase. We believe that our payment rates generally
reflect the costs that are associated with providing care to Medicare
beneficiaries in cost efficient settings, and we believe that our
payment rates are adequate to ensure access to services.
[[Page 68329]]
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to continue to assign
CPT code 37223 to APC 0083 for CY 2013.
Comment: One commenter believed that CPT codes 37234
(Revascularization, endovascular, open or percutaneous, tibial/peroneal
artery, unilateral, each additional vessel; with transluminal stent
placement(s), includes angioplasty within the same vessel, when
performed (list separately in addition to code for primary procedure)),
and 37235 (Revascularization, endovascular, open or percutaneous,
tibial/peroneal artery, unilateral, each additional vessel; with
transluminal stent placement(s) and atherectomy, includes angioplasty
within the same vessel, when performed (list separately in addition to
code for primary procedure)) are inappropriately assigned to APC 0083,
and recommended that they be reassigned to APC 0229. The commenter
indicated that these procedures involve both angioplasty with stent
placements, similar to the procedure described by CPT code 37221
(Revascularization, endovascular, open or percutaneous, iliac artery,
unilateral, initial vessel; with transluminal stent placement(s),
includes angioplasty within the same vessel, when performed), which is
assigned to APC 0229. The commenter also stated that CPT codes 37234
and 37235 are similar to the stent procedures described by CPT codes
37205 (Transcatheter placement of an intravascular stent(s) (except
coronary, carotid, vertebral, iliac, and lower extremity arteries),
percutaneous; initial vessel) and 37206 (Transcatheter placement of an
intravascular stent(s) (except coronary, carotid, vertebral, iliac, and
lower extremity arteries), percutaneous; each additional vessel (list
separately in addition to code for primary procedure)), which are
assigned to APC 0229. The commenter concluded that the payment rate for
APC 0083 does not reflect the resources associated with placement of a
cardiovascular stent; therefore, CPT codes 37234 and 37235 should be
reassigned to APC 0229.
Response: We continue to believe that APC 0083 is the most
appropriate assignment for these CPT codes based on clinical and
resource considerations. We do not agree that the procedures described
by CPT codes 37234 and 37235 are dissimilar to other procedures in APC
0083 because they involve a stent. In addition, an analysis of CY 2011
claims data shows only one single claim for CPT code 37234 (out of 153
total claims) and no single claims (out of 31 total claims) for CPT
code 37235. Therefore, the outpatient claims data do not support an APC
reassignment of these CPT codes. Because these CPT codes were made
effective January 1, 2011, CY 2011 is the first year of claims data
available for CPT codes 37234 and 37235. Consistent with CMS' policy of
reviewing APC assignments annually, we will reevaluate the cost of
these procedures and their APC assignments next year for the CY 2014
rulemaking cycle.
After consideration of the public comment we received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT codes 37234 and 37235 to APC 0083, which has a CY 2013 final
geometric mean cost of approximately $4,139.
Table 22 below provides the list of endovascular revascularization
CPT codes assigned to APCs 0083, 0229, and 0319 for CY 2013.
[[Page 68330]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.034
e. External Electrocardiographic Monitoring (APC 0097)
In the CY 2012 OPPS/ASC final rule with comment period, we assigned
new CPT codes 0296T (External electrocardiographic recording) and 0297T
(External electrocardiographic recording; scanning analysis with
report) on an interim basis to APC 0097 (Level I Non-Invasive
Physiologic Studies), which has a CY 2012 payment rate of approximately
$68 and a CY 2013 proposed payment rate of approximately $67.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period supported our placement of CPT code 0296T in
APC 0097. The commenter stated that the service described by CPT code
0296T is clinically similar to other services in that APC. However, the
commenter believed that CPT code 0297T would be more appropriately
assigned to APC 0692 (Level II Electronic Analysis of Devices), which
has a CY 2013 proposed rule cost of approximately $113). The commenter
argued that CPT code 0297T is similar in nature and in required
resources to CPT code 93271 (Electrocardiographic monitoring and
analysis), which is assigned to APC 0692, because it has a similar
monitoring period and requires similar network and information
technology resources.
Response: Based on our understanding of the resources that are
required to furnish the services described by CPT codes 93271 and
0297T, we do not agree with the commenter. The service described by CPT
code 93271 includes 24-hour attended monitoring, while the service
described by CPT 0297T does not. Therefore, we believe that CPT code
0297T is more clinically similar to the services assigned to APC 0097.
Therefore, for CY 2013, we will continue to assign this service to APC
0097, which has a final CY 2013 geometric mean cost of approximately
$68. We will reevaluate the APC placement using our standard
ratesetting methodology when we receive claims data for these services.
f. Echocardiography (APCs 0177, 0178, 0269, 0270, and 0697)
Under the OPPS, echocardiography services are reported using a
combination of CPT codes and HCPCS C-codes. Hospitals report the
echocardiography CPT codes when performing echocardiography procedures
without contrast. Alternatively, hospitals report the HCPCS C-codes
when performing echocardiography procedures with contrast, or
procedures without contrast followed by procedures with contrast. In
addition to the HCPCS C-codes, hospitals should also report the
appropriate units of the HCPCS codes for the contrast agents used in
the performance of the echocardiograms.
Currently, there are four APCs that describe echocardiography
services:
APC 0128 (Echocardiogram With Contrast)
APC 0697 (Level I Echocardiogram Without Contrast)
APC 0269 (Level II Echocardiogram Without Contrast)
[[Page 68331]]
APC 0270 (Level III Echocardiogram Without Contrast)
For CY 2013, we proposed payment rates for these APCs of
approximately $571, $212, $392, and $558, respectively.
Comment: One commenter expressed concern regarding the APC
assignment of the procedures for fetal echocardiography to APC 0697.
The commenter believed that this APC classification and payment rate
are inconsistent with the resources required to perform fetal
echocardiography studies. These resources, the commenter noted,
substantially exceed the resources generally needed for adult services.
Therefore, the commenter recommended that CMS reassign fetal
echocardiography CPT codes 76825 (Echocardiography, fetal,
cardiovascular system, real time with image documentation (2d), with or
without m-mode recording;) and 76826 (Echocardiography, fetal,
cardiovascular system, real time with image documentation (2d), with or
without m-mode recording; follow-up or repeat study) to the same APC as
adult echocardiography procedures, APC 0269 (Level II Echocardiogram
Without Contrast).
Response: For the CY 2013 OPPS/ASC proposed rule, we proposed to
assign CPT codes 76825 and 76826 to APC 0697, which had a proposed
payment rate of $211.71. As we stated in the CY 2012 OPPS/ASC final
rule with comment period, because these codes have been in existence
for almost 20 years, and have been reportable under the OPPS since it
was implemented in 2000, we believe that the low frequency of these
services is the result of infrequent use of this procedure on Medicare
beneficiaries. Analysis of our claims data from past years revealed
that these procedures are relatively low volume procedures. CPT code
76825 has had fewer than 330 single claims for ratesetting for each
year with a cost that has ranged between approximately $88 and
approximately $140. Similarly, CPT code 76826 has had fewer than 50
single claims for ratesetting for each year with a cost that has ranged
between approximately $85 and approximately $92. For this CY 2013 OPPS/
ASC final rule with comment period, CPT codes 76826 and 76825 are
assigned APCs with payment rates that exceed their respective
individual geometric mean costs. Therefore, based on our claims data,
we believe that CPT codes 76825 and 76826 are appropriately assigned to
APC 0697 for CY 2013 based on their clinical homogeneity and resource
costs of the other procedure assigned to APC 0697.
Comment: Several commenters expressed concern regarding a violation
of the 2 times rule for APC 0128 and urged CMS not to finalize an
exemption from the 2 times rule for APC 0128. The commenters stated
that the assignment of HCPCS codes C8924 (Transthoracic
echocardiography with contrast, or without contrast followed by with
contrast, real-time with image documentation (2d), includes m-mode
recording, when performed, follow-up or limited study) and C8930
(Transthoracic echocardiography, with contrast, or without contrast
followed by with contrast, real-time with image documentation (2d),
includes m-mode recording, when performed, during rest and
cardiovascular stress test using treadmill, bicycle exercise and/or
pharmacologically induced stress, with interpretation and report;
including performance of continuous electrocardiographic monitoring,
with physician supervision) to APC 0128 results in a violation of the 2
times rule in particular, and that the other procedures assigned to APC
0128 are not clinically comparable in nature, therefore resulting in an
APC payment rate that does not reflect the wide range of resources
utilized for the procedures assigned to APC 0128. The commenters
further recommended that CMS reconfigure APC 0128 so that the
procedures are clinically similar with respect to resources. One
commenter recommended that CMS adopt three levels of contrast-enhanced
APCs that parallel the three APCs that have been established for non-
contrast enhanced procedures.
Response: As stated above, we have four separate APCs to which
echocardiography services are assigned. Procedures that utilize
contrast agents are currently assigned to APC 0128, while procedures
without contrast agents are assigned to one of three APCs, specifically
APC 0270, APC 0269, or APC 0697. In the CY 2013 OPPS/ASC proposed rule,
we proposed a payment rate for APC 0128 of approximately $571 for CY
2013. As we do every year, we reviewed our claims data for the services
assigned to APC 0128. Based on our review, and taking into
consideration the public comments received in response to the final
rule with comment period, we agree with commenters that APC 0128 has a
2 times violation that cannot be exempted for this CY 2013 OPPS/ASC
final rule with comment period. As we have stated in section III.B. of
this final rule with comment period, we make exemptions to the 2 times
rule's limit on the variation of costs within each APC group in unusual
cases, such as low volume items and services. In deciding to propose
exemptions to the 2 times rule, we look at the respective APC's
resource homogeneity, clinical homogeneity, hospital outpatient
setting, frequency of service (volume), and opportunity for upcoding
and code fragmentation. We believe that, for this CY 2013 OPPS/ASC
final rule with comment period, it would be inappropriate to exempt APC
0128 from the 2 times rule and to continue to assign echocardiography
services utilizing contrast agents to one APC, based on our evaluation
of the aforementioned criteria. Therefore, for CY 2013, we are
splitting APC 0128 to create two new level APCs: APC 0177 (Level I
Echocardiogram with Contrast) and APC 0178 (Level II Echocardiogram
with Contrast).
After consideration of the public comments we received, we are
finalizing our proposals, with the modifications mentioned above, to
continue to calculate the costs of the HCPCS codes describing the non-
contrast echocardiography procedures based on APCs 0697, 0269, and
0270, and to calculate the costs for the HCPCS codes describing
contrast echocardiography procedures based on new APCs 0177 and 0178.
For a more detailed discussion and history of the OPPS payment for
echocardiography services, we refer readers to the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66644 through 66646), the CY 2009
OPPS/ASC final rule with comment period (72 FR 68542 through 68544),
and the CY 2010 OPPS/ASC final rule with comment period (74 FR 60374
through 60383).
Table 23 below shows the procedure assignments and the final
geometric mean cost assigned to echocardiography APCs, including the
new Level I and Level II Echocardiogram with Contrast APCs.
BILLING CODE 4120-01-P
[[Page 68332]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.035
BILLING CODE 4120-01-C
2. Gastrointestinal Services
a. Laparoscopic Adjustable Gastric Band (APC 0132)
Effective January 1, 2006, the AMA's CPT Editorial Panel
established CPT code 43770 (Laparoscopy, surgical, gastric restrictive
procedure; placement of adjustable gastric restrictive device (eg,
gastric band and subcutaneous port components)) to describe the
bariatric placement of an adjustable band by laparoscopy. From January
1, 2006 through December 31, 2011, CPT code 43770 was assigned to
status indicator ``C'' to indicate that the procedure was not paid
separately under the OPPS because the procedure was considered an
``inpatient'' procedure. However, in the CY 2012 OPPS/ASC final rule
(76 FR 74355), we stated that we received a comment requesting that
this CPT code be removed from the inpatient list and assigned to a
separately payable APC, effective January 1, 2012. Based on input from
our physicians and review of our claims data, we determined that it was
appropriate to remove CPT code 43770 from the inpatient list because
patients undergoing this procedure can typically be managed
postoperatively as outpatients. Consequently, we assigned CPT code
43770 to APC 0131 (Level II Laparoscopy), effective January 1, 2012.
At the August 2012 HOP Panel meeting, a presenter requested that
the Panel recommend to CMS the reassignment of CPT code 43770 from APC
0131 to a new APC. The commenter expressed concern about the existing
APC assignment and indicated that APC 0131 does not adequately cover
the costs of performing the procedure. After discussion of the
[[Page 68333]]
procedure and review of the hospital outpatient claims data, the Panel
recommended that CPT code 43770 remain in APC 0131 for the CY 2013
update.
For CY 2013, we proposed to continue to assign CPT code 43770 to
APC 0131, which had a proposed rule payment rate of approximately
$3,497.
Comment: Several commenters disagreed with the proposal to continue
to assign CPT code 43770 to APC 0131 because the procedure is different
from other procedures assigned to this APC. According to one commenter,
the procedures assigned to APC 0131 are less intensive (for example,
resource cost) than CPT code 43770. Another commenter stated that the
procedures assigned to APC 0131 are not similar to CPT code 43770
because this procedure includes the implantation of a gastric band
device as well as a port device, while the other procedures assigned to
this APC do not. In addition, some commenters believed that assignment
of CPT code 43770 to APC 0131 violates the 2 times rule. According to
the commenters, there is no existing APC that includes procedures that
are comparable to the procedures described by CPT code 43770, both
clinically and in terms of resource utilization. Therefore, they
requested that CMS establish a new APC for CPT code 43770 to ensure the
most appropriate payment for this procedure.
However, we received conflicting statements on the issue of
clinical comparability from some of the commenters. One commenter
stated that, although there is no existing APC that accurately fits
with CPT code 43770, the commenter mentioned that APC 0132 (Level III
Laparoscopy) does include some procedures that are more clinically
comparable to CPT code 43770 than the procedures assigned to APC 0131,
and suggested that APC 0132 would be an appropriate APC assignment for
this procedure. Another commenter considered suggesting a reassignment
of CPT code 43770 to APC 0132 but stated that the procedures assigned
to APC 0132 are not comparable in terms of resource utilization.
Although most of the commenters agreed that establishing a new APC for
CPT code 43770 would be more appropriate, some commenters suggested
assigning the procedure to APC 0132 as an interim APC assignment if a
new APC cannot be established for the CY 2013 update.
Response: We do not agree with the commenters' assertion that
assigning CPT code 43770 to APC 0131 violates the 2 times rule. In
determining whether a 2 times rule violation exists in an APC, we
consider only those HCPCS codes that are significant based on the
number of claims. For purposes of identifying significant HCPCS codes
for examination in the 2 times rule, we consider codes that have more
than 1,000 single major claims or codes that have both greater than 99
single major claims and comprise at least 2 percent of the single major
claims used to establish the costs of the procedures assigned to an APC
to be significant (75 FR 71832). This longstanding definition of when a
HCPCS code is significant for purposes of the 2 times rule was selected
because we believe that a subset of 1,000 claims is negligible within
the set of approximately 100 million single procedure or single session
claims we use for establishing costs. Similarly, a HCPCS code for which
there are fewer than 99 single claims and which comprises less than 2
percent of the single major claims within an APC will have a negligible
impact on the costs of the procedures in an APC. For the CY 2013 OPPS/
ASC proposed rule, claims data for CPT code 43770 showed 171 single
claims out of 216 total claims and comprised less than 1 percent of the
claims for procedures within APC 0131. Although CPT code 43770 had more
than 99 single major claims, it did not contribute to at least 2
percent of the single major claims for procedures within APC 0131.
Therefore, in the CY 2013 OPPS/ASC proposed rule, we determined that
assigning CPT code 43770 to APC 0131 did not violate the 2 times rule
because it did not meet the definition of a significant HCPCS code.
As stated above, the HOP Panel made a recommendation to continue to
assign CPT code 43770 to APC 0131 for the CY 2013 update. However,
after the Panel meeting, we reviewed our more recent claims data for
this final rule with comment period, and our analysis revealed that the
procedure would be more appropriately assigned to APC 0132 (Level III
Laparoscopy). Specifically, our analysis showed 213 single claims (out
of 262 total claims) for CPT code 43770 with a geometric mean cost of
approximately $7,410. Furthermore, our analysis revealed that CPT code
43770 meets the definition of significant claims because the procedure
represents more than 99 single major claims and contribute to at least
2 percent of the claims for procedures within APC 0132. Consequently,
we do not agree with the Panel's recommendation, and are reassigning
CPT code 43770 to APC 0132.
In summary, after consideration of the public comments we received,
we are revising the APC assignment for CPT code 43770 from APC 0131 to
0132 for CY 2013. The final CY 2013 geometric mean cost for APC 0132 is
approximately $5,268.
b. Transoral Incisionless Fundoplication (APC 0422)
For CY 2013, we proposed to continue to assign CPT code C9724
(Endoscopic full-thickness plication in the gastric cardia using
endoscopic plication system (eps); includes endoscopy) to APC 0422
(Level III Upper GI Procedures), which had a proposed payment rate of
approximately $1,878.
We note that at the August 2012 HOP Panel meeting, a presenter
requested that the Panel recommend to CMS the reassignment of HCPCS
code C9724 from APC 0422 to a new APC, or alternatively, to establish a
new APC with a descriptor of ``Level IV Upper GI Procedures.'' The
commenter stated that the payment rate for APC 0422 does not cover the
cost of providing the procedure. After discussion of the procedure and
review of the hospital outpatient claims data, the Panel recommended
that HCPCS code C9724 remain in APC 0422 for the CY 2013 update.
Comment: Several commenters disagreed with the proposal to continue
to assign HCPCS code C9724 to APC 0422. The commenters stated that the
proposed payment rate for APC 0422 would not cover the cost of
performing the procedure. According to the commenters, the cost of
performing the procedure is approximately $5,000. The commenters urged
CMS to either reassign HCPCS code C9724 to APC 1565 (New Technology--
Level XXVIII ($5000-$5500)), which had a proposed payment rate of
approximately $5,250, or establish a new APC titled ``Level IV Upper GI
Procedures'' with a payment rate of approximately $5,000.
Response: HCPCS code C9724, which was established by CMS effective
April 1, 2005, describes an endoscopic full-thickness plication
procedure for the treatment of gastroesophageal reflux disease (GERD).
Since April 2005, HCPCS code C9724 has been assigned to APC 0422.
Because this code has been in existence since April 2005, we have
claims data for several years. For this final rule with comment period,
which is based on claims submitted from January 1, 2011 through
December 31, 2011, our data show a geometric mean cost of approximately
$5,728 based on 24 single claims (out of 120 total claims) for HCPCS
code C9724. In addition, we agree with the Panel's recommendation to
maintain HCPCS code C9724 in APC 0422 for the CY 2013 update. Based on
the clinical similarity to other
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procedures currently assigned to APC 0422, and because there is no
violation with the 2 times rule, we will continue to assign HCPCS code
C9724 to APC 0422. Consistent with CMS' policy of reviewing APC
assignments annually, we will reevaluate the cost of HCPCS code C9724
and its APC assignment for the CY 2014 rulemaking cycle.
In addition, because of concerns related to the current descriptor
for HCPCS code C9724, we are revising the long descriptor to read
``Endoscopic full-thickness plication of the stomach using endoscopic
plication system (eps); includes endoscopy,'' effective January 1,
2013. This change in the long descriptor is necessary to accurately
describe how the procedure is currently performed.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal without modification and will continue
to maintain HCPCS code C9724 in APC 0422. The final CY 2013 geometric
mean cost for APC 0422 is approximately $1,921.
c. Gastrointestinal Transit and Pressure Measurement (APC 0361)
The AMA's CPT Editorial Panel created CPT code 0242T
(Gastrointestinal tract transit and pressure measurement, stomach
trough colon, wireless capsule, with interpretation and report)
effective January 1, 2011. For CY 2011, we initially assigned CPT code
0242T to APC 0361 (Level II Alimentary Tests), with a payment rate of
$282.48.
For CY 2012, we maintained the assignment of CPT code 0242T to APC
0361 with a payment rate of $285.59. We noted in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74242) that we routinely make
assignments of new CPT codes to clinical APCs before we have claims
data that are indicative of the resource costs of a procedure. We make
these assignments initially using the best currently available
information, while reviewing claims data once such data become
available and making reassignments accordingly based on those data.
We stated in the CY 2012 OPPS/ASC final rule with comment period
that, as was the case when we made the initial assignment for CY 2011,
we continued to believe that there are relevant clinical similarities
between the service described by CPT code 0242T and other services
assigned to APC 0361 to continue to justify this APC assignment. The
service described by CPT code 0242T and the services assigned to APC
0361 all involve tests of the alimentary canal. We believed that the
clinical attributes and CY 2012 costs of the services assigned to APC
0361 supported the initial assignment of CPT code 0242T to APC 0361. We
indicated that we routinely make assignments of new CPT codes to
clinical APCs before we have claims data to indicate the procedural
resource costs, and that we generally wait until claims data are
available before reassignment to a new APC. For CY 2012, we maintained
our assignment of CPT code 0242T to APC 0361, which has a final median
cost of $285.89, and we stated that we would review this assignment for
CY 2013 when some claims data should be available for this procedure.
For CY 2013, we proposed to maintain the assignment of CPT code
0242T to APC 0361, which had a proposed rule geometric mean cost of
approximately $311 and a proposed payment rate of approximately $303.
We now have a small number of claims for use in CY 2013 for CPT code
0242T, which had a proposed rule geometric mean cost of approximately
$613. The range of procedure level costs in APC 0361 for the CY 2013
proposed rule was approximately $214 to approximately $633. This range
of costs does not constitute a 2 times rule violation because the range
of costs for procedures with significant volume in the APC is
approximately $302 to approximately $406.
We did not receive any public comments on our proposed APC
assignment of CPT code 0242T to APC 0361.
At the August 2012 meeting of the HOP Panel, the Panel recommended
that CMS assign CPT code 0242T to APC 0142 (Level I Small Intestine
Endoscopy), based on the procedure's proposed rule mean cost of
approximately $613, with a frequency of 8 claims.
Our CY 2013 final rule claims data show a cost of approximately
$497 for CPT code 0242T, based on 8 claims. Our analysis comparing the
proposed rule data and the final rule data for CPT code 0242T shows
that one claim was dropped and another added, resulting in the
fluctuation in geometric mean costs for the small number of claims
between the proposed rule dataset and the final rule dataset for this
procedure. The CY 2013 final geometric mean cost for APC 0361 is
approximately $311, which includes a range of costs for procedures in
the APC of approximately $209 to approximately $633. The CY 2013 final
geometric mean cost for APC 0142 is approximately $772, which includes
a range of costs for procedures in the APC of approximately $569 to
approximately $826. Therefore, based on the final rule geometric mean
cost for CPT code 0242T, assignment of the code to APC 0361 is
appropriate. We also continue to believe that CPT code 0242T is similar
clinically to other procedures assigned to APC 0361. Therefore we are
maintaining our assignment of the CPT code 0242T procedure to APC 0361
for CY 2013.
We note that the CPT Editorial Panel is replacing the CPT code for
the procedure described by CPT code 0242T with a Category I CPT code,
CPT code 91112 (Gastrointestinal transit and pressure measurement,
stomach trough colon, wireless capsule, with interpretation and
report), effective January 1, 2013. Therefore, we are deleting CPT code
0242T from the OPPS effective January 1, 2013, and assigning
replacement CPT code 91112 to APC 0361 for this procedure.
3. Integumentary System Services
a. Extracorporeal Shock Wave Wound Treatment (APC 0340)
In the CY 2012 OPPS/ASC final rule with comment period, we assigned
new CPT codes 0299T (Extracorporeal shock wave for integumentary wound
healing, initial wound) and 0300T (Extracorporeal shock wave for
integumentary wound healing, each additional wound) on an interim basis
to APC 0340 (Minor Ancillary Procedures), which has a CY 2012 payment
rate of approximately $46 and a CY 2013 proposed rule payment rate of
approximately $49.
Comment: One commenter objecting to the interim APC assignment of
CPT codes 0299T and 0300T believed that the assignment is not
consistent clinically or in terms of the resources associated with the
shock wave treatment procedures. The commenter stated that these
services are more similar clinically and in related resources to the
high-energy shock wave procedure for musculoskeletal conditions that is
assigned to APC 0050 (Level II Musculoskeletal Procedures Except Hand
and Foot), which has a CY 2012 payment rate of approximately $2,269.
The commenter believed that assignment of these codes to a New
Technology APC would be appropriate to gather cost data, and indicated
that they would submit an application for new technology payments for
these codes to CMS.
We received other similar comments to the proposed rule from
several clinicians in the field who were involved in the initial
clinical trial of the extracorporeal shock wave procedure. These
commenters discussed
[[Page 68335]]
the clinical trial and the clinical attributes of this treatment,
indicating that it offers significantly greater clinical benefit than
other wound healing therapies at a considerably lower cost. They
objected to CMS' assignment of CPT codes 0299T and 0300T to APC 0340.
The commenters believed that the payment rate for this APC would
inhibit the use of this emerging technology and would prevent patient
access to the treatment.
Response: We agree with the commenters that it may be more
appropriate in terms of clinical and resource similarity to assign CPT
codes 0299T and 0300T to an APC other than APC 0340. However, we do not
agree that CPT codes 0299T and 0300T should be assigned to APC 0050.
Having considered the information provided by the commenters, and based
on our evaluation of clinical and resource similarity to existing
services, we believe that placement in APC 0133 (Level I Skin Repair)
would be more appropriate for these services until claims data are
available. For CY 2013, we are placing CPT codes 0299T and 0300T in APC
0133, which has a final geometric mean cost of approximately $88. We
will reevaluate the APC placement when claims data are available for CY
2014.
b. Application of Skin Substitute (APCs 0133 and 0134)
For CY 2012, we made assignments for several new (replacement) CPT
codes for the application of skin substitutes. We assigned CPT code
15272 (Application of skin substitute graft to trunk, arms, legs, total
wound surface area up to 100 sq cm; each additional 25 sq cm or part
thereof) and CPT code 15276 (Application of skin substitute graft to
face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet
and/or multiple digits, total wound surface area up to 100 sq cm; each
additional 25 sq cm or part thereof) to APC 0133 (Level I Skin Repair),
which has a CY 2012 payment rate of approximately $84 and a CY 2013
proposed payment rate of approximately $86. We assigned CPT code 15274
(Application of skin substitute graft to trunk, arms, legs, total wound
surface area greater than or equal to 100 sq cm; each additional 100 sq
cm or part thereof) and CPT code 15278 (Application of skin substitute
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet and/or multiple digits, total wound surface area greater
than or equal to 100 sq cm; each additional 100 sq cm or part thereof)
to APC 0134 (Level II Skin Repair), which has a CY 2012 payment rate of
approximately $228 and a CY 2013 proposed payment rate of approximately
$252.
Comment: One commenter stated that CMS should have assigned the new
codes to the APC that includes their predecessor base codes so that a 2
times rule violation is avoided. They requested that for CY 2013, CMS
reassign CPT codes 15272 and 15276 to APC 0134, crosswalking them to
the predecessor add-on CPT code 15341 and assign them to the same APC
as the former base CPT code 15340. Similarly, the commenter requested
that CMS reassign CPT codes 15274 and 15278 to APC 0135 (Level III Skin
Repair) which includes their applicable base codes (CPT codes 15273 and
15277).
Response: As we indicated in the CY 2012 OPPS/ASC final rule (76 FR
74269), we assigned these four replacement CPT codes for CY 2012 based
on their clinical and estimated resource similarity to the services in
their assigned APCs. We also took into account the size descriptions in
the new codes' long descriptors. There was not a one-to-one crosswalk
between the old skin substitute application codes and the new CPT
codes, as suggested by the commenter. Several of the old CPT codes map
to a single new code. Therefore, we made the most appropriate
assignment based on clinical homogeneity and estimated resource
similarity, taking into account all of the former procedures that are
now encompassed by a single code and the new coding structure for the
family of codes.
For CY 2013, we will continue to assign CPT codes 15272 and 15276
to APC 0133, which has a final geometric mean cost of approximately
$88, and CPT codes 15274 and 15278 to APC 0134, which has a final
geometric mean cost of approximately $259. We will reevaluate the
placement of these codes when claims data become available in the CY
2014 rulemaking cycle.
c. Low Frequency, Non-Contact, Non-Thermal Ultrasound (APC 0015)
Effective January 1, 2008, the CPT Editorial Panel created CPT code
0183T (Low Frequency, Non-Contact, Non-Thermal Ultrasound). Since that
time, we have assigned this service to either APC 0013 (Level II
Debridement and Destruction) or APC 0015 (Level III Debridement and
Destruction). Initially, for CY 2008 and CY 2009, we placed this
service in the higher Level III APC 0015, with a payment rate of
approximately $100. Based on our review of the first year of hospital
claims data (CY 2008 claims), for CY 2010 we reassigned the service to
the lower Level II APC 0013, with a payment rate of approximately $59.
For CY 2011 and CY 2012, due to a change in the estimated cost of CPT
code 0183T, we reassigned it to the higher level APC 0015, with a
payment rate of approximately $105 in CY 2011 and approximately $103 in
CY 2012.
For CY 2013, we proposed to reassign CPT 0183T to APC 0013 because
its proposed rule geometric mean cost of approximately $89 was closer
to the proposed rule geometric mean cost of APC 0013 (approximately
$73) than the proposed rule geometric mean cost of APC 0015
(approximately $110).
Comment: One commenter objected to the reassignment of CPT code
0183T to APC 0013 because the commenter's estimated cost of furnishing
this service of approximately $101 would be greater than its proposed
payment. The commenter believed that procedures currently assigned to
APC 0013 and those assigned to APC 0015 are not homogeneous clinically
or in terms of resource requirements. The commenter requested that CMS
split APC 0013 and APC 0015 to create a third APC, such that APC 0013
would include the services with costs less than $80; the new APC would
include services with costs between $80 and $110; and APC 0015 would
include services with costs greater than or equal to $110.
Another commenter recommended that CMS merge APC 0013 and APC 0015,
arguing that both APCs are for skin procedures and noting that the
proposed cost for the highest volume service in APC 0013, described by
CPT code 17000 (Destruction of premalignant lesions; first lesion), is
more than half of the cost of the highest volume service in APC 0015,
described by CPT code 97597 (Open wound debridement; first 20 sq cm or
less).
Response: The final rule geometric mean cost of CPT code 0183T and
APC 0013 (approximately $88 and $74, respectively) did not change
significantly from their proposed rule costs and remain very similar.
There also is no significant change in the final rule geometric mean
cost of APC 0015 (approximately $110). We note that merging the two
APCs as one commenter suggested would create several 2-times rule
violations, and we see no clinical or other need to further split the
APCs. Therefore, because the geometric mean cost of CPT code 0183T
continues to be closer to the geometric mean cost of APC 0013 than that
of APC 0015, and because merging the APCs would create several 2 times
rule violations, for CY 2013, we are finalizing our proposal to
reassign CPT code 0183T to APC 0013.
[[Page 68336]]
4. Nervous System Services
a. Scrambler Therapy (APC 0275)
For the CY 2012 update, the AMA's CPT Editorial Panel established
Category III CPT code 0278T (Transcutaneous electrical modulation pain
reprocessing (eg, scrambler therapy), each treatment session (includes
placement of electrodes)) effective January 1, 2012. CPT code 0278T
describes a transcutaneous electrical modulation pain reprocessing
procedure and involves the use of four to five electrodes that deliver
electrical stimulation to treat chronic chemo-induced neuropathic pain.
Based on the nature of the procedure, which can be performed by
physicians, nurses, or physical therapists, the therapy involves 10
sessions (1 session per day for 10 days), and each session takes
approximately between 30 and 45 minutes.
In Addendum B of the CY 2012 OPPS/ASC final rule with comment
period, we assigned CPT code 0278T to APC 0215 (Level I Nerve and
Muscle Tests) which has a CY 2012 payment rate of approximately $44. We
also assigned this CPT code comment indicator ``NI'' to indicate that
the code was new for CY 2012 with an interim APC assignment that was
subject to public comment following the publication of the final rule
with comment period. Specifically, the code's APC assignment and status
indicator were subject to public comment. We received one public
comment regarding the interim APC assignment for CPT code 0278T which
we address below in this section.
We note that we do not discuss APC or status indicator assignments
for new codes for the upcoming year in the proposed rule because the
new codes are not available when we publish the proposed rule. Rather,
as has been our practice in the past, we implement new HCPCS codes in
the OPPS final rule with comment period, at which time we invite public
comments regarding the treatment of the new codes. We subsequently
respond to those comments in the final rule with comment period for the
following year's OPPS update.
As has been our practice since the implementation of the OPPS in
2000, we carefully review all new procedures before assigning them to
an APC. In determining the APC assignment for CPT code 0278T, we took
into consideration the clinical and resource characteristics involved
with Scrambler Therapy. Based on our initial review of the components
of these services and consultation with our medical advisors, we
assigned CPT code 0278T to APC 0215 for CY 2012.
At the February 2012 HOP Panel meeting, a presenter requested the
reassignment of CPT code 0278T from APC 0215 to APC 0206 (Level II
Nerve Injections) based on resource cost and clinical homogeneity. The
presenter stated that the assignment of CPT code 0278T to APC 0215 is
not appropriate because the procedures in this APC are primarily
diagnostic in nature, whereas CPT code 0278T represents a therapeutic
procedure. The presenter further added that the time and cost involved
with providing the service associated with CPT code 0278T is
considerably greater than the time and cost involved for procedures
assigned to APC 0215, and recommended that the Scrambler Therapy would
be more appropriately assigned to APC 0206 because the procedures in
APC 0206 are mostly therapeutic in nature and represent similar costs.
At the February 2012 meeting, the Panel made no recommendation to
reassign CPT code 0278T from its current APC 0215 assignment for CY
2013.
In Addendum B of the CY 2013 OPPS/ASC proposed rule, we proposed to
continue to assign CPT code 0278T to APC 0215. At the August 2012 HOP
Panel meeting, the same presenter at February 2012 Panel meeting made
the same request to the Panel to recommend to CMS to reassign CPT code
0278T to a more appropriate APC. Specifically, at the August 2012 HOP
Panel meeting, the requester recommended that CPT code 0278T be
reassigned to APC 0204 (Level I Nerve Injections) based on clinical and
cost considerations. During the discussion, one of the Panel members
pointed out that the procedures assigned to APC 0204 represent nerve
injections, which is in contrast to how the procedure described by CPT
code 0278T is delivered because the procedure associated with the
Scrambler Therapy does not involve injections. After discussion of the
issue, the HOP Panel recommended that CMS assign CPT code 0278T to APC
0218 (Level II Nerve and Muscle Tests).
Comment: One commenter to the CY 2012 OPPS/ASC final rule with
comment period recommended the reassignment of CPT code 0278T from APC
0215 to APC 0206 based on the commenter's cost analysis. Alternatively,
the commenter recommended assignment of CPT code 0278T to APC 0204
because this is the APC assigned to unlisted CPT code 64999 (Unlisted
procedure, nervous system), which would be used to report the Scrambler
Therapy if CPT code 0278T had not been established.
Response: As a new Category III CPT code for CY 2012, we do not yet
have hospital claims data for the procedure. Category III CPT codes are
temporary codes that describe emerging technology, procedures, and
services, and are created by the AMA to allow for data collection for
new services or procedures. Under the OPPS, we generally assign a
payment rate to a new Category III CPT code based on input from a
variety of sources, including but not limited to, review of resource
costs and clinical homogeneity of the service to existing procedures,
information from specialty societies, input from CMS medical advisors,
and other information available to us. Based on our review of the
clinical characteristics of the service described by CPT code 0278T and
the information provided by the commenter, we do not believe that we
have sufficient clinical or cost information to justify a reassignment
to a different APC at this time. As we do every year for other services
and procedures under the OPPS, we will review the claims data for CPT
code 0278T for CY 2012 for the CY 2014 rulemaking cycle. Because CPT
code 0278T was a new code for CY 2012, the first time we will have
claims data for this procedure is next year for the CY 2014 update, and
at which time we will reevaluate the APC assignment for this code.
Comment: Some commenters recommended a range of the appropriate
payment for CPT code 0278T based on their internal analysis. One
commenter recommended that CPT code 0278T be assigned to an APC that
has a payment rate of between $124 to $144 based on their analysis, by
taking into consideration the site of service, staff time involved, and
system costs associated with providing the therapy. Another commenter
stated that the total cost of providing Scrambler Therapy is
approximately $274; however, an initial payment of approximately $184
may be adequate for hospitals to initiate treatment. The commenter
further stated that the proposed payment rate of approximately $81 for
APC 0218, which was recommended by the HOP Panel at the August 2012
meeting, is adequate. However, the commenter asserted that the proposed
payment rate of approximately $150 for New Technology APC 1540 (New
Technology--Level III ($100--$200)) would be more appropriate.
Response: After further review of the HOP Panel recommendation at
the August 2012 meeting and consideration of the public comments that
we received on this particular procedure, we believe that we should
continue to assign the
[[Page 68337]]
Scrambler Therapy to APC 0215. Therefore, we are not accepting the
Panel's recommendation to reassign CPT code 0278T to APC 0218. In
addition, we do not agree with the commenter that CPT code 0278T should
be assigned to New Technology APC 1540. Based on our understanding of
the procedure, we believe that APC 0215 is the most appropriate APC
assignment for CPT code 0278T based on its similarity to other
procedures assigned to APC 0215. We will review the claims data for CPT
0278T next year for the CY 2014 rulemaking to determine whether an APC
reassignment for the Scrambler Therapy is necessary.
After consideration of the public comments received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT code 0278T to APC 0215 for CY 2013. The final CY 2013
geometric mean cost for APC 0215 is approximately $44.
b. Transcranial Magnetic Stimulation Therapy (TMS) (APC 0216)
Since July 2006, CPT codes have existed to describe Transcranial
Magnetic Stimulation Therapy (TMS) therapy. The initial CPT codes were
temporary Category III CPT codes, specifically, CPT code 0160T
(Therapeutic repetitive transcranial magnetic stimulation treatment
planning) and 0161T (Therapeutic repetitive transcranial magnetic
stimulation treatment delivery and management, per session), that were
effective July 1, 2006. For CY 2011, the CPT Editorial Panel deleted
CPT code 0160T on December 31, 2010, and replaced it with CPT code
90867 (Therapeutic repetitive transcranial magnetic stimulation (tms)
treatment; initial, including cortical mapping, motor threshold
determination, delivery and management) effective January 1, 2011.
Similarly, CPT code 0161T was deleted on December 31, 2010, and was
replaced with CPT code 90868 (Therapeutic repetitive transcranial
magnetic stimulation (tms) treatment; subsequent delivery and
management, per session) effective January 1, 2011. In CY 2012, the
AMA's CPT Editorial Panel established an additional TMS therapy code,
specifically CPT code 90869 (Therapeutic repetitive transcranial
magnetic stimulation (tms) treatment; subsequent motor threshold re-
determination with delivery and management), that was effective January
1, 2012.
In Addendum B of the CY 2013 OPPS/ASC proposed rule, we proposed to
continue to assign CPT codes 90867, 90868, and 90869 to APC 0218 (Level
II Nerve and Muscle Tests), which had a proposed payment rate of
approximately $81.
Comment: One commenter disagreed with the proposed APC assignment
and stated that the TMS therapy codes are not similar to the services
assigned to APC 0218. The commenter recommended three options on the
appropriate APC assignment.
Under the first option, the commenter recommended the reassignment
of CPT codes 90867, 90868, and 90869 to APC 0216 (Level III Nerve and
Muscle Tests), which had a proposed payment rate of approximately $182.
The commenter also recommended the revision of the APC title
description to read ``Level III Nerve and Muscle Tests & TMS''. The
commenter stated that the TMS therapy services are similar to the
services described by CPT codes 95961 (Functional cortical and
subcortical mapping by stimulation and/or recording of electrodes on
brain surface, or of depth electrodes, to provoke seizures or identify
vital brain structures; initial hour of physician attendance), 95962
(Functional cortical and subcortical mapping by stimulation and/or
recording of electrodes on brain surface, or of depth electrodes, to
provoke seizures or identify vital brain structures; each additional
hour of physician attendance (list separately in addition to code for
primary procedure)), and 96000 (Comprehensive computer-based motion
analysis by video-taping and 3d kinematics), which are assigned to APC
0216.
Under the second option, the commenter recommended the
establishment of a new APC for the three TMS therapy CPT codes, and
further recommended revising the APC title description to read
``Transcranial Magnetic Stimulation''.
Under the third option, the commenter suggested assigning CPT codes
90867, 90868, and 90869 to APC 0320 (Electroconvulsive Therapy), which
had a proposed payment rate of approximately $441. Although TMS therapy
is clinically related to electroconvulsive therapy (ECT), the commenter
stated that its resource costs are lower than ECT.
Response: We appreciate the commenter's thoughtful suggestions on
the APC assignments for CPT codes 90867, 90868, and 90869. We do not
agree with the commenter that the procedures described by CPT codes
90867, 90868, and 90869 would be appropriately assigned to APC 0320
from a clinical perspective because the provision of electroconvulsive
therapy generally requires more extensive monitoring and services (for
example, muscle blockade) than transcranial magnetic treatment delivery
and management. However, based on the latest claims data used for this
rulemaking, we do agree with the commenter's suggestion that APC 0216
would be the more appropriate APC assignment for the three TMS therapy
CPT codes. Analysis of our more recent claims data revealed that the
resources associated with CPT codes 90867, 90868, and 90869 are similar
to those services assigned to APC 0216. Specifically, for claims
submitted during CY 2011, which were used for this final rule with
comment period, CPT code 90867 showed a geometric mean cost of
approximately $190 based on 15 single claims (out of 18 total claims),
and a geometric mean cost of approximately $233 for CPT code 90868
based on 609 single claims (out of 614 total claims). In addition,
review of the procedures assigned to APC 0216 showed that the range of
the geometric mean cost for the procedures with significant claims data
is between approximately $146 (for CPT code 92584
(Electrocochleography)) and approximately $233 (for CPT code 90868
(Tcranial magn stim tx deli)). Based on the clinical and resource
similarity to other procedures currently assigned to this APC, we
believe it is appropriate to reassign the TMS therapy services to APC
0216. Although CPT code 90869 is a new code for CY 2012, we believe
that it is appropriate to reassign this service to APC 0216, similar to
the APC assignment of CPT codes 90867 and 90868. Because of this
reassignment, we also are revising the APC title descriptions of APCs
0215, 0216, and 0218 to appropriately reflect the services within each
APC. Specifically, we are revising the APC title description of APC
0215 from ``Level I Nerve and Muscle Tests'' to ``Level I Nerve and
Muscle Services''; the title description of APC 0218 from ``Level II
Nerve and Muscle Tests'' to ``Level II Nerve and Muscle Services''; and
the title description of APC 0216 from ``Level III Nerve and Muscle
Tests'' to ``Level III Nerve and Muscle Services''.
After consideration of the public comment we received, we are
finalizing our CY 2013 proposal, with modification. That is, we are
reassigning CPT codes 90867, 90868, and 90869 from APC 0218 to APC
0216, which has a final CY 2013 geometric mean cost of approximately
$189. Table 24 below shows the final APC assignments for CPT codes
90867, 90868, and 90869 for CY 2013.
[[Page 68338]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.036
c. Paravertebral Neurolytic Agent (APC 0207)
Effective January 1, 2012, the AMA's CPT Editorial Panel created
CPT code 64633 (Destruction by neurolytic agent, paravertebral facet
joint nerve(s), with imaging guidance (fluoroscopy or ct); cervical or
thoracic, single facet joint). For CY 2012, we assigned new CPT code
64633 on an interim basis to APC 0207 (Level III Nerve Injections).
This interim APC assignment was consistent with our standard process
for dealing with new CPT codes effective on January 1 for the upcoming
calendar year, which is to assign each code to the APC that we believe
contains services that are comparable with respect to clinical
characteristics and resources required to furnish the service. CPT code
64633 was assigned a comment indicator of ``NI'' in Addendum B to the
CY 2012 OPPS/ASC final rule with comment period to identify it as a new
interim APC assignment for the new year and the APC assignment for this
new code was open to public comment for 60 days following the
publication of the CY 2012 OPPS/ASC final rule with comment period. For
CY 2013, we proposed to continue to assign CPT code 64633 to APC 0207,
which had a proposed payment rate of approximately $568.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period objected to the assignment of CPT code 64633
to APC 0207 because the commenter believed that the payment rate for
APC 0207 substantially underpays providers for this service.
Response: Due to the lack of any claims data for CPT code 64633, we
have no way to validate or substantiate the claim made by the
commenter. We expect to have CY 2012 claims data for CPT code 64633
available in CY 2013 in preparation for the CY 2014 rulemaking cycle
and will reevaluate the APC assignment of CPT code 64633 at that time.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT code 64633 to APC 0207, which has a final CY 2013 APC
geometric mean cost of approximately $582.
d. Programmable Implantable Pump (APC 0691)
Effective January 1, 2012, the AMA's CPT Editorial Panel created
two new CPT codes that combine pump refill and programming/analysis
procedures: CPT code 62369 (Electronic analysis of programmable,
implanted pump for intrathecal or epidural drug infusion (includes
evaluation of reservoir status, alarm status, drub prescription
status); with reprogramming and refill) and CPT code 62370 (Electronic
analysis of programmable, implanted pump for intrathecal or epidural
drug infusion (includes evaluation of reservoir status, alarm status,
drub prescription status); with reprogramming and refill (requiring
physician's skill)). For CY 2012, CPT codes 62369 and 62370 received a
new interim APC assignment to APC 0691 (Level III Electronic Analysis
of Devices), consistent with our standard process for dealing with new
CPT codes effective on January 1 for the upcoming calendar year, which
is to assign each code to the APC that we believe contains services
that are comparable with respect to clinical characteristics and
resources required to furnish the service. CPT codes 62369 and 62370
were both given a comment indicator of ``NI'' in Addendum B to the CY
2012 OPPS/ASC final rule with comment period to identify it as a new
interim APC assignment for the new year and the APC assignment for
these two new codes was open to public comment for 60 days following
the publication of the CY 2012 OPPS/ASC final rule with comment period.
For CY 2013, we proposed to continue to assign CPT codes 62369 and
62370 to APC 0691, which had a proposed payment rate of approximately
$192.
Comment: Commenters who responded to the CY 2012 OPPS/ASC final
rule with comment period objected to the assignment of CPT codes 62369
and 62370 to APC 0691 because they believed that the payment rate for
APC 0691 substantially underpays providers for these services.
Response: Due to the lack of any claims data for CPT codes 62369
and 62370, we have no way to validate or substantiate the claim made by
commenters. We expect to have CY 2012 claims data for CPT codes 62369
and 62370 in CY 2013 in preparation for the CY 2014 rulemaking cycle
and will reevaluate the APC assignment of CPT codes 62369 and 62370 at
that time.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT codes 62369 and 62370 to APC 0691, which has a final CY 2013
APC geometric mean cost of approximately $197.
e. Revision/Removal of Neurostimulator Electrodes (APC 0687)
For CY 2013, we proposed to continue to assign CPT code 64569
(Revision or replacement of cranial nerve (eg, vagus nerve)
neurostimulator electrode array, including connection to existing pulse
generator) to APC 0687 (Revision/Removal of Neurostimulator
Electrodes), which had a proposed CY 2013 payment rate of approximately
$1,576.
Comment: Commenters objected to the assignment of CPT code 64569 in
APC 0687 because they stated that this code is used to report both the
revision and the replacement of neurostimulator electrodes. The
commenters believed that hospital resources are substantially greater
when neurostimulator electrodes are being replaced rather than revised.
The commenters asked CMS to reassign CPT code 64569 to device-dependent
APC 0040 (Level I Implantation/Revision/Replacement of
[[Page 68339]]
Neurostimulator Electrodes) or assign new HCPCS codes to differentiate
between electrode replacements (with a new electrode) and electrode
revisions (without a new electrode) so that electrode revisions map to
APC 0687 and electrode replacements map to APC 0040. The commenters
noted that, like CPT code 64569, the procedures currently assigned to
APC 0040 involve the implantation of a new electrode, either as an
initial implant or as a replacement, while all of the procedures
currently assigned to APC 0687, with the exception of CPT code 64569,
are defined as ``revision or removal'' or simply ``removal'' of
electrodes. The commenters stated that the resources associated with
the procedure described by CPT code 64569 are similar to the resources
associated with the procedures assigned to APC 0040.
Response: We agree with the commenters that the resources
associated with the procedure described by CPT code 64569 are similar
to the resources associated with procedures assigned to APC 0040, and
that these procedures share clinical characteristics. We note that the
CY 2013 final rule geometric mean cost for CPT code 64569 of
approximately $5,473 is more consistent with the CY 2013 final rule
geometric mean cost of APC 0040 of approximately $4,526 than with the
CY 2013 final rule geometric mean cost of APC 0687 of approximately
$1,554. Therefore, we are modifying our proposal and assigning CPT code
64569 to APC 0040 for CY 2013.
5. Ocular Services: Placement of Amniotic Membrane (APC 0233)
In CY 2011, the AMA CPT Editorial Panel revised the long descriptor
for CPT code 65780 (Ocular surface reconstruction; amniotic membrane
transplantation, multiple layers) to include the words ``multiple
layers'' to further clarify the code descriptor. In addition, the AMA's
CPT Editorial Panel created two new CPT codes that describe the
placement of amniotic membrane on the ocular surface without
reconstruction: one describing the placement of a self-retaining (non-
sutured/non-glued) device on the surface of the eye; and the other
describing a single layer of amniotic membrane sutured to the surface
of the eye. Specifically, the AMA's CPT Editorial Panel established CPT
codes 65778 (Placement of amniotic membrane on the ocular surface for
wound healing; self-retaining) and 65779 (Placement of amniotic
membrane on the ocular surface for wound healing; single layer,
sutured), effective January 1, 2011.
As has been our practice since the implementation of the OPPS in
2000, we review all new procedures before assigning them to an APC. In
determining the APC assignments for CPT codes 65778 and 65779, we took
into consideration the clinical and resource characteristics involved
with placement of amniotic membrane products on the eye for wound
healing via a self-retaining device and a sutured, single-layer
technique. In the CY 2011 OPPS/ASC final rule with comment period (75
FR 72402), we assigned CPT code 65778 to APC 0239 (Level II Repair and
Plastic Eye Procedures), which had a payment rate of approximately
$559, and CPT code 65779 to APC 0255 (Level II Anterior Segment Eye
Procedures), which had a payment rate of approximately $519.
In addition, consistent with our longstanding policy for new codes,
we assigned these two new CPT codes to interim APCs for CY 2011.
Specifically, we assigned CPT codes 65778 and 65779 to comment
indicator ``NI'' in Addendum B of the CY 2011 OPPS/ASC final rule with
comment period to indicate that the codes were new with interim APC
assignments that were subject to public comment. In accordance with our
longstanding policy, our interim APC assignment for each code was based
on our understanding of the resources required to furnish the service
as defined in the code descriptor and input from our physicians.
At the Panel's February 28-March 1, 2011 meeting, a presenter
requested the reassignment of CPT codes 65778 and 65779 to APC 0244
(Corneal and Amniotic Membrane Transplant), which is the same APC to
which CPT code 65780 is assigned. The presenter indicated that, prior
to CY 2011, the procedures described by CPT codes 65778 and 65779 were
previously reported under the original version of CPT code 65780, which
did not specify ``multiple layers,'' and as such these new CPT codes
should continue to be assigned to APC 0244. Further, the presenter
stated that the costs of the procedures described by CPT codes 65778
and 65779 are very similar to the cost of the procedure described by
CPT code 65780.
The Panel recommended that CMS reassign the APC assignments for
both CPT codes 65778 and 65779. Specifically, the Panel recommended the
reassignment of CPT code 65778 from APC 0239 to APC 0233 (Level III
Anterior Segment Eye Procedures), and the reassignment of CPT code
65779 from APC 0255 to APC 0233. In addition, the Panel recommended
that CMS furnish data when data become available for these two codes.
We noted at that time that because these CPT codes were effective
January 1, 2011, the first available claims data for these codes would
be for the CY 2013 OPPS rulemaking cycle.
We accepted the Panel's recommendations. However, in the CY 2012
OPPS/ASC final rule with comment period (76 FR 74247), we indicated
that, while we agreed with the Panel's recommendation to reassign CPT
codes 65778 and 65779 to APC 0233, we believed that CPT code 65778
should be assigned to a conditionally packaged status indicator of
``Q2'' to indicate that the procedure would be packaged when it is
reported with another procedure that is also assigned to status
indicator ``T''; but in all other circumstances, the CPT code would be
paid separately. Because the procedure described by CPT code 65778
would rarely be provided as a separate, stand-alone service in the
HOPD, and because the procedure would almost exclusively be provided in
addition to and following another procedure or service, we proposed to
reassign CPT code 65778 a conditionally packaged status indicator of
``Q2.'' In addition, our medical advisors indicated that the procedure
described by CPT code 65778 is not significantly different than placing
a bandage contact lens on the surface of the eye to cover a corneal
epithelial defect. CPT code 65778 describes the simple placement of a
special type of bandage (a self-retaining amniotic membrane device) on
the surface of the eye, which would most commonly be used in the HOPD
to cover the surface of the eye after a procedure that results in a
corneal epithelial defect.
At the August 10-11, 2011 Panel meeting, a presenter urged the
Panel to recommend to CMS not to conditionally package CPT code 65778
for CY 2012, and instead, assign it status indicator ``T.'' Based on
information presented at the meeting, and after further discussion of
the issue, the Panel recommended that CMS reassign the status indicator
for CPT code 65778 from conditionally packaged ``Q2'' to status
indicator ``T.'' Several commenters also urged CMS not to finalize its
proposal to conditionally package CPT code 65778 by assigning it status
indicator ``Q2'' and instead adopt the Panel's recommendation to assign
status indicator ``T.''
After consideration of the Panel's August 2011 recommendation and
the public comments that we received in response to the CY 2012 OPPS/
ASC
[[Page 68340]]
proposed rule, we finalized our proposal and reassigned the status
indicator for CPT code 65778 from ``T'' to ``Q2'' effective January 1,
2012 (76 FR 74246). Given the clinical characteristics of this
procedure, we believed that conditionally packaging CPT code 65778 was
appropriate under the OPPS.
For the CY 2013 OPPS update, we proposed (77 FR 45123) to continue
to assign CPT code 65778 a conditionally packaged status indicator of
``Q2.'' Similarly, we stated that we believe that we should assign CPT
code 65779 to a conditionally packaged status indicator of ``Q2.''
Therefore, for CY 2013, we proposed to revise the status indicator for
CPT code 65779 from status indicator ``T'' to ``Q2'' to indicate that
the procedure would be packaged when it is reported with another
procedure that is also assigned status indicator ``T,'' but in all
other circumstances, the CPT code would be paid separately. This
reassignment would enable hospitals to perform either procedures (CPT
code 65778 or 65779) when appropriate, and would not differentiate one
procedure from the other because of the status indicator assignment
under the OPPS.
As indicated at the February 28-March 1, 2011 Panel meeting,
because CPT codes 65778 and 65779 were effective January 1, 2011, the
first available claims data for these codes would be in CY 2012 for the
CY 2013 OPPS rulemaking. We now have claims data for CPT codes 65778
and 65779, and our data show that both procedures are performed in the
HOPD setting. Analysis of the CY 2011 claims data available for the
proposed rule, which was based on claims processed from January 1
through December 31, 2011, revealed that the estimated cost for CPT
code 65778 is approximately $1,025 based on 33 single claims (out of
130 total claims), and the estimated cost for CPT code 65779 is
approximately $2,303 based on 35 single claims (out of 260 total
claims). Based on the clinical similarity to other procedures currently
assigned to APC 0233, and because there was no violation with the 2
times rule, we stated that we believe that we should continue to assign
both CPT codes 65778 and 65779 to APC 0233, which had a payment rate of
approximately $1,150. Review of the procedures assigned to APC 0233
showed that the range of the cost for the procedures with significant
claims data is between approximately $859 (for CPT code 65400 (Removal
of eye lesion)) and approximately $1,397 (for CPT code 66840 (Removal
of lens material)).
In summary, for CY 2013, we proposed to continue to assign CPT code
65778 to a conditionally packaged status indicator of ``Q2'' and to
reassign the status indicator for CPT code 65779 from ``T'' to ``Q2,''
similar to CPT code 65778. In addition, we proposed to continue to
assign both CPT codes 65778 and 65779 to APC 0233, which had a proposed
geometric mean cost of approximately $1,150. Both procedures and their
CY 2013 APC assignments were displayed in Table 19 of the proposed
rule.
At the August 2012 HOP Panel Meeting, a presenter urged the Panel
to recommend to CMS not to conditionally package CPT code 65779 for CY
2013, and instead, assign status indicator ``T'' to the code. Based on
the information presented at the meeting, and after further discussion
of the issue, the HOP Panel made no recommendation to revise the status
indicator assignment for CPT code 65779.
Comment: One commenter urged CMS not to finalize its proposal to
conditionally package CPT code 65779 by assigning it status indicator
``Q2,'' and recommended that CMS continue to assign the code status
indicator ``T.'' The commenter expressed concern that assigning a
``Q2'' status indicator to CPT code 65779 would impede access to this
procedure because, in a majority of the cases (84 percent), hospitals
perform this procedure with another procedure. Consequently, a ``Q2''
status indicator would result in no payment for CPT code 65779. The
commenter further recommended that CMS assign CPT code 65779 to APC
0244, or another APC that better reflects the resources associated with
the procedure, such as APC 0241 (Level IV Repair and Plastic Eye
Procedures) or APC 0234 (Level IV Anterior Segment Eye Procedures).
Response: We believe that the revision in status indicator for CPT
code 65779 would enable hospitals to perform either procedures (CPT
code 65778 or 65779) when appropriate, and would not differentiate one
procedure from the other because of the status indicator assignment
under the hospital OPPS. In addition, because CPT codes 65778 and 65779
were new for CY 2011, CY 2013 is the first year of claims data that we
have available for ratesetting for both CPT codes. Analysis of the CY
2011 claims data revealed a geometric mean cost of approximately $989
for CPT code 65778 based on 36 single claims (out of 142 total claims),
and approximately $2,314 for CPT code 65779 based on 37 single claims
(out of 280 total claims). Review of the procedures assigned to APC
0233 showed that the range of the CPT geometric mean cost for the
procedures with significant claims data is between approximately $867
(for CPT code 65400 (Removal of eye lesion)) and approximately $1,390
(for CPT code 66840 (Removal of lens material)). Based on the clinical
similarity to other procedures currently assigned to APC 0233, and
because there is no violation with the 2 times rule, we believe that we
should continue to assign CPT code 65779 to APC 0233, which has a final
geometric mean cost of approximately $1,162 for CY 2013.
As has been our practice since the implementation of the OPPS, we
annually review all the items and services within an APC group to
determine, with respect to comparability of the use of resources, for
any 2 times rule violations. In making this determination, we review
our claims data and determine whether we need to make changes to the
current APC assignments for the following year. For CPT codes 65778 and
65779, we will again reevaluate their APC assignments for the CY 2014
OPPS rulemaking cycle.
After consideration of the public comment that we received, we are
finalizing our CY 2013 proposal, without modification, to assign status
indicator ``Q2'' to CPT code 65779. When the service is furnished with
a separately payable surgical procedure with status indicator ``T'' on
the same day, payment for CPT code 65779 is packaged. Otherwise,
payment for CPT code 65779 is made separately through APC 0233, which
has a final CY 2013 geometric mean cost of approximately $1,162. The
amniotic membrane procedures and their CY 2013 final APC assignments
are displayed in Table 25 below.
[[Page 68341]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.037
6. Radiology Oncology
a. Proton Beam Therapy (APCs 0664 and 0667)
APC 0664 (Level I Proton Beam Radiation Therapy) includes two
procedures: CPT code 77520 (Proton treatment delivery; simple, without
compensation), which had a CY 2013 proposed rule cost of approximately
$331 (based on 185 single claims of 185 total claims submitted for CY
2011); and CPT code 77522 (Proton treatment delivery; simple, with
compensation), which had a proposed rule cost of approximately $1,191
(based on 14,279 single claims of 15,405 total claims submitted for CY
2011). APC 0667 (Level II Proton Beam Radiation Therapy) also includes
two procedures: CPT code 77523 (Proton treatment delivery,
intermediate), which had a proposed rule cost of approximately $920
(based on 3,009 single claims out of 3,202 total claims submitted for
CY 2011), and CPT code 77525 (Proton treatment delivery, complex),
which had a proposed rule cost of approximately $483 (based on 1,400
single claims out of 1,591 total claims submitted for CY 2011). Based
on these CY 2011 claims data, under the current APC structuring the
proposed rule cost of APC 0664 was approximately $1,171, and the
proposed rule cost of APC 0667 was approximately $750.
Because only a few hospitals bill Medicare for these services,
their payment rates, which are set annually based on claims data
according to the standard OPPS ratesetting methodology, may fluctuate
significantly from year to year. For CY 2013, under the current APC
assignments, the proposed rule cost of APC 0664 was approximately the
same as its CY 2012 payment rate of $1,184. However, the proposed rule
cost of APC 0667 decreased substantially from the CY 2012 payment rate.
We also observed that for CY 2013, as in several prior years, the lower
level APC 0664 did not include the lower cost services among the four
CPT codes. For CY 2013, we proposed to improve the resource homogeneity
within the proton beam therapy APCs by including the services requiring
fewer resources in APC 0664 (Level I) and the services requiring
greater resources in APC 0667 (Level II). Specifically, we proposed to
reassign CPT code 77522 to APC 0667 and to reassign CPT code 77525 to
APC 0664. Under the proposed reassignment, the estimated cost of APC
0664 was approximately $462, and the estimated cost of APC 0667 was
approximately $1,138. We invited public comments on this proposal.
Comment: Several commenters indicated that the decrease in the cost
of APC 0667 is attributable to inaccurate coding and cost reporting
during part of CY 2010 and part of CY 2011, on the part of one
hospital. The commenters stated that one hospital's services that
should have been billed as CPT code 77523 were instead billed as CPT
code77525, which has a lower estimated cost. They stated that these
services were also reported under an unintended cost center in the
hospital's cost report, and argued that the current APC configuration
better reflects the clinical similarity and relative resources used to
furnish proton beam therapy services. We received a comment from the
hospital in question indicating the same. This provider also stated
that these issues were corrected and do not affect any claims in CY
2012. These commenters requested that we therefore forego using the CY
2011 claims data to set CY 2013 rates because they are based in part on
inaccurate data reported by one of the few billing providers. They
requested that CMS maintain both the CY 2012 payment rates and the
current CY 2012 APC configuration through CY 2013, and the HOP Panel
agreed with this recommendation at its August 2012 public meeting.
One commenter recommended that CMS obtain corrected data from the
provider in question and use the corrected data in updating the CY 2012
proton beam therapy payment rates for CY 2013. The commenter
recommended that if CMS could not accomplish this in time for
publication of the CY 2013 final rule, CMS exclude the reportedly
erroneous data from its ratesetting process and update the CY 2012
payments for proton beam services for CY 2013 using the remaining
claims data. In either event, the commenter recommended that we not
restructure the APCs this year because despite what the cost data show,
simple and complex proton beam therapy services are not clinically
homogenous.
Another commenter supported the proposed reduction in payments for
proton beam services. The commenter stated that given the cost of
establishing and staffing proton beam centers, proton beam therapy does
not yield commensurate benefit over other therapies.
Response: We appreciate the public comments and the HOP Panel's
recommendation. After consideration of the public comments we received,
we are updating the payment rates for proton beam therapy for CY 2013
to reflect the most recently available claims data from all providers.
Therefore, we are not maintaining the CY 2013 payment rates at CY 2012
levels, and we are not excluding the reportedly erroneous data from the
ratesetting process. However, we are maintaining the current APC
structure for CY 2013 and will reevaluate the costs and appropriateness
of the APC structuring for proton beam services next year. Using the
current APC assignments for proton beam services, the CY 2013 final
geometric mean cost of APC 0664 (including CPT codes 77520 and 77522)
is approximately $1,169. The CY 2013 final geometric mean cost of APC
0667 (including CPT codes 77523 and 77525) is approximately $702.
[[Page 68342]]
b. Device Construction for Intensity Modulated Radiation Therapy (IMRT)
(APC 0305)
Effective January 1, 2010, the CPT Editorial Panel created CPT code
77338 (Construction of multi-leaf collimator (MLC) device(s) for IMRT
per IMRT plan) to report all of the devices furnished under a single
IMRT treatment plan. The code was created as part of an effort to
consolidate the reporting of multiple services or units of service into
a single code. For CY 2011, we assigned CPT 77338 to APC 0310 (Level
III Therapeutic Radiation Treatment Preparation) based on a simulated
cost of approximately $792 that we calculated using CY 2009 claims data
for the predecessor CPT code 77334 ((Treatment devices, design and
construction; complex (irregular blocks, special shields, compensators,
wedges, molds or casts)).
For CY 2012, using our standard ratesetting methodology and the
first year of available claims data for CPT code 77338, and based upon
a final rule cost of approximately $188, we reassigned this service
from APC 0310 to APC 0305 (Level II Therapeutic Radiation Treatment
Preparation) with a final payment rate of approximately $264. In our
response to public comments, we noted several possible reasons for the
discrepancy in the reported cost of the service relative to its
predecessor code. We stated that it is not unusual for providers to
bill a given service in a manner that is inconsistent with what we
would expect based on the definition of a new code. We also noted
potential clinical reasons for the apparent anomaly, such as the
inclusion of labor-intensive physical blocks, shields, and molds in the
service described by CPT code77334, and accounting rationales such as
the crosswalking of a single collimator setting to the charges for the
construction of a physical block, also in the service described by CPT
code 77334. We stated that we saw no basis to ignore our robust set of
single procedure claims submitted by a significant number of hospitals
by continuing to simulate a cost for CPT code 77338.
In the CY 2013 OPPS/ASC proposed rule Addenda, based on a proposed
rule cost of approximately $293, we proposed to continue the current
assignment of CPT code 77338 for CY 2013 to APC 0305, and to add this
service to the bypass list which would increase the number of claims
that could be used in setting its payment rate.
Comment: One commenter objected to the continued assignment of CPT
code 77338 to APC 0305. The commenter again noted the low estimated
cost of this service compared to its predecessor code, and continued to
believe that providers are inappropriately coding the service. They
requested that for CY 2013, we simulate the cost of this service using
the alternative methodology that we used in CY 2011, and that we
reassign the service to APC 0310, which has a final rule cost of
approximately $1,013.
Response: As we noted last year, we see no reason to discard the
reported claims data for CPT code 77338, which has a CY 2013 final rule
geometric mean cost of approximately $297. For the reasons previously
discussed, for CY 2013 we will continue assigning this CPT code to APC
0305, which has a final geometric mean cost of approximately $299. We
will reevaluate whether this placement is appropriate next year when
additional claims data are available.
c. Other Radiation Oncology Services (APCs 0310 and 0412)
Comment: One commenter addressed the proposed payment rates for the
following services: CPT code 77418 (Radiation treatment delivery
intensity modulated radiotherapy), which is assigned to APC 0412 (Level
II Radiation Therapy) and is separately paid; CPT code 77295 (3-D
Therapeutic radiology simulation-aided field setting), which is
assigned to APC 0310 (Level III Therapeutic Radiation Treatment
Preparation) and is also separately paid; CPT code 77373 (Stereotactic
body radiation therapy delivery), which has a status indicator of ``B''
(Not covered under the OPPS); and CPT code 77014 (CT scan for therapy
guidance), which has status indicator of ``N'' and is packaged. The
commenter expressed concern about perceived decreases in payment for
these services.
Response: Under our standard ratesetting methodology, we proposed a
slight payment increase for CPT 77418 from approximately $459 in CY
2012 to approximately $484 in CY 2013, based on a CY 2013 proposed rule
geometric mean cost of $497. Similarly, we proposed a slight payment
increase for CPT 77295 from approximately $953 in CY 2012 to
approximately $985 in CY 2013, based on a CY 2013 proposed rule
geometric mean cost of $988. The final CY 2013 geometric mean cost of
CPT 77418 is approximately $498, and the final CY 2013 geometric mean
cost of CPT 77295 is approximately $991.
Since 2007, we have not recognized CPT code 77373 under the OPPS,
and hospitals should instead report this service using HCPCS code G0251
(Linear accelerator based stereotactic radiosurgery, delivery). HCPCS
code G0251 is assigned to APC 0065 (Level I Stereotactic Radiosurgery,
MRgFUS, and MEG), whose payment rate also increased from CY 2012 (final
CY 2012 payment of approximately $902) to CY 2013 (final CY 2013
geometric mean cost of approximately $1,007). CPT code 77014 has been
packaged under the OPPS since 2008 when we implemented our guidance
services policy.
d. Stereotactic Radiosurgery (SRS) Treatment Delivery Services (APCs
0065, 0066, 0067, and 0127)
For CY 2013, we proposed to continue to assign CPT code 77371
(Radiation treatment delivery, stereotactic radiosurgery (SRS),
complete course of treatment of cranial lesion(s) consisting of 1
session; multi-source Cobalt 60 based) to APC 0127 (Level IV
Stereotactic Radiosurgery, MRgFUS, and MEG), which had a CY 2013
proposed payment rate of approximately $8,011.
We also proposed to continue to recognize four existing HCPCS G-
codes that describe linear accelerator-based SRS treatment delivery
services for separate payment in CY 2013. Specifically, we proposed the
following: to assign HCPCS code G0173 (Linear accelerator based
stereotactic radiosurgery, complete course of therapy in one session)
and HCPCS code G0339 (Image-guided robotic linear accelerator-based
stereotactic radiosurgery, complete course of therapy in one session or
first session of fractionated treatment) to APC 0067 (Level III
Stereotactic Radiosurgery, MRgFUS, and MEG), which had a CY 2013
proposed payment rate of approximately $3,294; to assign HCPCS code
G0251 (Linear accelerator-based stereotactic radiosurgery, delivery
including collimator changes and custom plugging, fractionated
treatment, all lesions, per session, maximum five sessions per course
of treatment) to APC 0065 (Level I Stereotactic Radiosurgery, MRgFUS,
and MEG), which had a CY 2013 proposed payment rate of approximately
$967; and to assign HCPCS code G0340 (Image-guided robotic linear
accelerator based stereotactic radiosurgery, delivery including
collimator changes and custom plugging, fractionated treatment, all
lesions, per session, second through fifth sessions, maximum five
sessions per course of treatment) to APC 0066 (Level II Stereotactic
Radiosurgery, MRgFUS, and MEG), which had a CY
[[Page 68343]]
2013 proposed payment rate of approximately $2,361.
Further, we proposed to continue to assign SRS CPT codes 77372
(Radiation treatment delivery, stereotactic radiosurgery (SRS)
(complete course of treatment of cerebral lesion(s) consisting of 1
session); linear accelerator based) and 77373 (Stereotactic body
radiation therapy, treatment delivery, per fraction to 1 or more
lesions, including image guidance, entire course not to exceed 5
fractions) status indicator ``B'' (Codes that are not recognized by
OPPS when submitted on an outpatient hospital Part B bill type (12x and
13x)) under the OPPS, to indicate that these CPT codes are not payable
under the OPPS.
Comment: One commenter urged CMS to reevaluate the APC assignments
for the linear accelerator-based (LINAC) and robotic Cobalt-60 based
stereotactic radiosurgery (r-SRS) HCPCS codes. The commenter stated
that no clinical data exist to support the need for differential
payments for LINAC-based and Cobalt-60 r-SRS procedures. The commenter
further explained that there is no clinical evidence to suggest that
one system is superior to the other, and the costs of purchasing and
maintaining the devices are similar. The commenter recommended that CMS
assign HCPCS code G0339 and CPT code 77371 to the same APC, thereby
establishing payment parity for the complete course of treatment for
intracranial and other head and neck r-SRS, regardless of equipment or
energy source. In addition, the commenter argued that this APC
reevaluation is necessary to protect the Medicare program and
beneficiaries from excessive costs associated with Cobalt-60-based
system, when both the LINAC-based and Cobalt-60-based systems are
similar in clinical homogeneity and resource costs.
Response: We disagree with the commenter's argument that the LINAC-
based and Cobalt-60 based systems have similar resource costs. For the
past several years, we have seen resource differences based on the
geometric mean costs for the LINAC-based and Cobalt-60-based systems,
and analysis of our claims data show that the geometric mean costs for
LINAC-based and Cobalt-60-based SRS procedures differ significantly.
Since CY 2007, when CPT code 77371 became effective, our claims data
have shown consistently a cost of more than $7,000 for the service
associated with the Cobalt-60-based system, which is higher than the
mean cost of approximately $3,500 for the LINAC-based system (described
by HCPCS G-code G0339).
Analysis of the updated CY 2011 claims data used for this final
rule with comment period indicates that the code-specific geometric
mean costs for the LINAC-based and Cobalt-60-based systems continue to
differ. Our updated claims data on the hospital outpatient claims
available for CY 2013 ratesetting show a geometric mean cost of
approximately $8,138 for CPT code 77371 based on 410 single claims (out
of a total of 4,598 claims), which is significantly higher than the
geometric mean costs associated with HCPCS codes G0173, G0251, G0339,
and G0340. Specifically, our claims data indicate a geometric mean cost
of approximately $2,605 for HCPCS code G0173 based on 923 single claims
(out of a total of 1,597 claims), a geometric mean cost of
approximately $1,007 for HCPCS code G0251 based on 12,965 single claims
(out of a total of 13,746 claims), a geometric mean cost of
approximately $3,497 for HCPCS code G0339 based on 8,287 single claims
(out of a total of 10,462 claims), and a geometric mean cost of
approximately $2,423 for HCPCS code G0340 based on 25,444 single claims
(out of a total of 25,708 claims). Because the geometric mean costs of
HCPCS code G0339 and CPT code 77371 differ significantly, we do not
believe it would be appropriate to provide OPPS payment through a
single APC for these r-SRS treatment delivery services in CY 2013. We
continue to believe that APC 0127 is an appropriate APC assignment for
CPT code 77371, and, similarly, that APC 0067 is an appropriate APC
assignment for HCPCS code G0339 based on consideration of the clinical
characteristics associated with these procedures and based on the
geometric mean costs for these services calculated from the most
recently available hospital outpatient claims and cost report data.
Consistent with our current policy to annually assess the
appropriateness of the APC assignments for all services under the
hospital OPPS, we will continue to monitor our claims data for the SRS
treatment delivery services in the future.
As we have stated in the past (74 FR 60456), the OPPS is a
prospective payment system, where APC payment rates are based on the
relative costs of services as reported to us by hospitals according to
the most recent claims and cost report data as described in section
II.A. of this final rule with comment period. The 2 times rule
specifies that the mean cost of the highest cost item or service within
a payment group may be no more than 2 times greater than the mean cost
of the lowest cost item or service within the same group. Based on the
2 times rule, HCPCS code G0339 and CPT code 77371 could not be assigned
to the same APC and, because hospitals continue to report very
different costs for these services, we believe it is appropriate to
maintain their assignments to different payment groups for CY 2013. As
a matter of payment policy, the OPPS does not set payment rates for
services based on considerations of clinical effectiveness.
Furthermore, in accordance with the statute, we budget neutralize the
OPPS each year in the annual update so that projected changes in
spending for certain services are redistributed to payment for other
services.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposals, without modification, to continue to
assign CPT code 77371 to APC 0127, which has a final CY 2013 APC
geometric mean cost of approximately $8,138, and to continue to assign
HCPCS code G0339 to APC 0067, which has a final CY 2013 APC geometric
mean cost of approximately $3,395.
e. Intraoperative Radiation Therapy (IORT) (APC 0412)
(1) Background
The AMA's CPT Editorial Panel created three new Category I CPT
codes for intraoperative radiation therapy (IORT), effective January 1,
2012: CPT codes 77424 (Intraoperative radiation treatment delivery, x-
ray, single treatment session); 77425 (Intraoperative radiation
treatment delivery, electrons, single treatment session); and 77469
(Intraoperative radiation treatment management). As with all new CPT
codes for CY 2012, these three codes were included in Addendum B to the
CY 2012 OPPS/ASC final rule with comment period (available via the CMS
Web site), effective on January 1, 2012. In accordance with our
standard practice each year, our clinicians review the many CPT code
changes that will be effective in the forthcoming year and make
decisions regarding status indicators and/or APC assignments based on
their understanding of the nature of the services. We are unable to
include proposed status indicators and/or APC assignments in the
proposed rule for codes that are not announced by the AMA's CPT
Editorial Panel prior to the issuance of the proposed rule. Therefore,
in accordance with our longstanding policy, we include, in the final
rule with comment period, interim status indicators and/or APC
assignments for all new CPT codes that are announced by the AMA's CPT
Editorial Panel subsequent to the issuance of the OPPS/ASC proposed
[[Page 68344]]
rule to enable payment for new services as soon as the codes are
effective.
We identified the new codes for IORT for CY 2012 in Addendum B to
the CY 2012 OPPS/ASC final rule with comment period as being open to
public comment by showing a comment indicator of ``NI'' and made
interim status indicator assignments for each of these new IORT codes,
based on our understanding of the clinical nature of the services they
describe. Specifically, for CY 2012, we packaged these IORT service
codes with the surgical procedures with which they are billed,
assigning them interim status indicators of ``N'' (Items and Services
Packaged into APC Rates). We did so based on a policy that was adopted
in the CY 2008 OPPS final rule with comment period (72 FR 66610 through
66659) to package services that are typically ancillary and supportive
of a principal diagnostic or therapeutic procedure, which would
generally include intraoperative services. Because IORT are
intraoperative services furnished as a single dose during the time of
the related surgical session, we packaged them into the payment for the
principal surgical procedures with which they are performed based on
claims data used for the CY 2012 OPPS/ASC final rule with comment
period.
Subsequent to issuance of the CY 2012 OPPS/ASC final rule with
comment period, stakeholders provided comments on the interim status of
these IORT service codes for CY 2012, asserting that these services are
not ancillary to the surgical procedures, urging us to unpackage these
codes, and requesting that we assign them to an APC reflective of the
resources used to provide the IORT services. Commenters who responded
to the CY 2012 OPPS/ASC final rule with comment period argued that IORT
services described by CPT codes 77424 and 77425 are separate, distinct,
and independent radiation treatment services from the surgical services
to remove a malignant growth. According to the commenters, IORT is
performed separately by a radiation oncologist and a medical physicist
when there is concern for residual unresected cancer because of narrow
margins related to the surgical resection. A number of the commenters
provided varied estimates of the cost of IORT as between $4,000 and
$7,000 per treatment, and some commenters cited a hospital survey of
per treatment costs for the procedure described by CPT code 77424 of
$4,441.17 and for the procedure described by CPT code 77425 of
$6,897.50.
One commenter stated that the x-ray intraoperative service
described by CPT code 77424 has previously been reported with CPT code
0182T (High dose rate electronic brachytherapy, per fraction), which is
a separately paid OPPS service. However, the commenter pointed out that
it would not be proper to report intraoperative radiation therapy with
CPT code 0182T because now CPT codes 77424 and 77425 more specifically
and accurately describe the intraoperative radiation services. One
commenter recommended that CPT code 77425 be mapped to a new technology
APC.
(2) CY 2013 Proposals for CPT Codes 77424, 77425, and 77469
Based on the public comments and information received on the IORT
policies contained in the CY 2012 OPPS/ASC final rule with comment
period, and after further review and consideration of those public
comments and the clinical nature of the IORT procedures, we agreed that
IORT services are not the typical intraoperative services that we
package, as they are not integral to or dependent upon the surgical
procedure to remove a malignancy that precedes IORT. Therefore, for CY
2013, we proposed to unpackage CPT codes 77424 and 77425 and assign
them to APC 0412, currently titled ``IMRT Treatment Delivery'' (77 FR
45124). We stated that IORT treatment services are clinically similar
to other radiation treatment forms, such as IMRT treatment, which are
assigned to APC 0412. Furthermore, we proposed to change the title of
APC 0412 to ``Level III Radiation Therapy'' to encompass a greater
number of clinically similar radiation treatment modalities. The CY
2013 proposed rule geometric mean cost for APC 0412, based on CY 2011
claims data, was approximately $496. We also proposed to monitor
hospitals' costs for furnishing the services described by CPT codes
77424 and 77425.
In the CY 2013 proposed rule, we stated that we believe that CPT
code 77469 should receive equal treatment to other radiation management
codes, such as CPT code 77431 (Radiation therapy management with
complete course of therapy consisting of 1 or 2 fractions only) and CPT
code 77432 (Stereotactic radiation treatment management of cranial
lesion(s) (complete course of treatment consisting of 1 session)),
which are assigned status indicator ``B'' (Codes that are not
recognized by OPPS when submitted on an outpatient hospital Part B bill
type (12x and 13x)) and are not paid under the OPPS. Therefore, we
proposed that the appropriate status indicator code assignment for CPT
code 77469 be ``B'' for nonpayable status under the OPPS for CY 2013, a
change from its current CY 2012 status indicator assignment of ``N''
for packaged payment status.
At its August 2012 meeting, the HOP Panel recommended that CMS
assign CPT code 77424 and CPT code 77425 to APC 0313 (Brachytherapy),
and consider renaming the APC ``Brachytherapy and Intraoperative
Radiation Therapy.'' The Panel also recommended that CMS present to the
Panel cost data regarding CPT codes 77424 and 77425, when available or
by the August 2013 Panel meeting.
Comment: Many commenters supported the proposal to unpackage CPT
codes 77424 and 77425, but objected to the proposed assignment of these
codes to APC 0412. The commenters asserted that APC 0412 is neither
reflective of the clinical characteristics nor the resources needed to
perform the IORT services described by CPT codes 77424 and 77425. The
commenters pointed out the clinical differences between IORT and IMRT,
in that IORT provides a much higher dose of radiation during a single
fraction (session) lasting about 45 minutes, while IMRT provides lower
doses over multiple fractions lasting about 15 minutes. The commenters
asserted that IMRT's cost over the full course of therapy is $17,000 to
$20,000, much higher than IORT's cost.
Many commenters requested that CMS assign CPT codes 77424 and 77425
to an appropriate APC based on clinical similarity to other radiation
treatments and suggested that CMS use external cost data to estimate
the costs of IORT, because cost data from hospital claims are not yet
available for these new CPT codes. Some commenters recommended that CPT
codes 77424 and 77425 be assigned to APC 0313 (Brachytherapy), which
has a proposed payment rate of approximately $685, because the IORT
services are more similar to brachytherapy services than the IMRT
services currently assigned to APC 0412. These commenters asserted that
both IORT and brachytherapy involve placement of a radiation source
inside or next to the area of the body requiring treatment, while IMRT,
which is a form of external beam radiation therapy, delivers radiation
from outside the body. The commenters opined that CPT codes 77424 and
77425 and the APC 0313 brachytherapy procedures have similar resource
costs, particularly because the X-ray based IORT procedure is
comparable to high dose rate (HDR) brachytherapy, and the X-ray based
IORT system may be used for the delivery of fractionated breast
brachytherapy, often billed with CPT
[[Page 68345]]
code 0182T (High dose rate electronic brachytherapy, per fraction),
which is assigned to APC 0313.
Several other commenters stated that IORT is very different than
HDR brachytherapy, as well as IMRT and multi-fraction stereotactic
radiosurgery, in terms of both clinical characteristics and resource
costs. Commenters stated that IORT capital equipment can only be used
for IORT in the operating room, and not for other forms of radiation
therapy, resulting in less patient utilization over which to spread
costs. These commenters recommended that CMS assign CPT codes 77424 and
77425 to APC 0067 (Level III Stereotactic Radiosurgery, MRgFUS, and
MEG), which has a proposed payment rate of approximately $3,294. These
commenters believed that IORT is more similar clinically to
stereotactic radiosurgery (SRS) than IMRT, pointing out that SRS may be
delivered in single or multiple fraction therapy and has many fewer
(that is, 2 to 5) fractions, making it more similar to IORT, in that
regard. A few commenters recommended that CMS assign IORT to a New
Technology APC, with a wide range of recommended payment rates, from
approximately $4,000 to approximately $7,000, citing various data
estimates and sources including a survey of hospitals.
Regarding our proposal to change the status indicator for CPT code
77469 to ``B'' and make the service non-payable, one commenter
supported the proposed change on the basis that it is consistent with
our policy regarding other radiation treatment management codes.
Response: We appreciate all of the feedback we received on the CY
2012 interim status indicator assignment of ``N'' to CPT codes 77424
and 77425 and the CY 2013 proposal to assign these CPT codes to APC
0412. As stated in the CY 2013 OPPS/ASC proposed rule and described
above, we agree with the commenters that IORT services are not the
typical intraoperative services that we package, as they are not
integral to or dependent upon the surgical procedure to remove a
malignancy that precedes IORT.
We agree with commenters that the resource costs of APC 0412 do not
fit well with single fraction radiation therapy technologies, such as
IORT. However, we believe the resource costs of IORT can be
accommodated by one of the existing APCs for radiation therapy, and
therefore, a new technology APC assignment is not needed. From a
clinical standpoint, we agree with commenters that the procedures
described by CPT codes 77424 and 77425 share important characteristics
with SRS, particularly because SRS may be a single fraction therapy or
involve many fewer fractions than IMRT. Based on the range of claimed
costs provided by the commenters, which are all based on external
costs, as we do not yet have claims data, there is clearly a wide range
of reported or estimated costs for IORT services, and, as some
commenters indicate, there may be a difference in the cost structures
of CPT codes 77424 and 77425.
After consideration of the public comments we received, we believe
that an appropriate initial APC assignment for CPT codes 77424 and
77425 is APC 0065 (Level I Stereotactic Radiosurgery, MRgFUS, and MEG),
in terms of clinical characteristics, and the range of estimated costs
for IORT services. Therefore, for CY 2013, we are assigning CPT codes
77424 and 77425 to APC 0065, which has a CY 2013 final geometric mean
cost of approximately $1,006. We will review the APC assignment of CPT
codes 77424 and 77425, individually, once we have OPPS hospital claims
data. Regarding the Panel recommendation that we present to the Panel
cost data regarding CPT codes 77424 and 77425, we agree to provide cost
data from claims for these service codes when available.
7. Imaging
a. Non-Ophthalmic Fluorescent Vascular Angiography (APC 0397)
Effective April 1, 2012, we created HCPCS code C9733 (Non-
ophthalmic fluorescent vascular angiography (FVA)) for a service that
became known to us via the new technology APC application process. We
assigned HCPCS code C9733 to APC 0397 (Vascular Imaging), which has a
CY 2012 payment rate of $154.87 and a status indicator assignment of
``Q2.'' The ``Q2'' status indicator provides that the service will have
packaged APC payment if billed on the same date of service as a HCPCS
code assigned status indicator ``T''; and in all other circumstances,
there is a separate APC payment for the service. We proposed to
continue to assign HCPCS code C9733 to APC 0397 for CY 2013, which had
a CY 2013 proposed payment rate of $192.21, and to continue the
assignment of the code to the ``Q2'' status indicator.
The HOP Panel, at its August 2012 meeting, recommended that CMS
maintain a status indicator of ``Q2'' for HCPCS code C9733, while
making no recommendation as to its APC assignment. The proposed payment
rate for APC 0397 was $197.08, with a range in individual procedure
geometric mean costs from $140.78 to $202.97. We proposed the
assignment of HCPCS code C9733 to APC 0397 because we believed that the
service described by HCPCS code C9733 is similar in clinical
characteristics to other vascular imaging services. We do not have
claims cost data available for HCPCS code C9733 because it was made
effective on April 1, 2012. For new HCPCS codes, our longstanding
policy is to wait until we have claims data on new services before
considering them for reassignment to clinical APCs other than the
originally assigned APC.
Comment: A number of commenters were appreciative that CMS created
a new HCPCS code for non-ophthalmic FVA, but were concerned with the
packaged status that would result from assigning HCPCS code C9733
status indicator ``Q2'' because the procedure is usually performed with
a service having a ``T'' status indicator. A few commenters pointed out
that FVA is effective in assessing perfusion in tissue, and is
particularly useful when vascular function is diminished. A number of
commenters pointed out that the procedure is performed intraoperatively
for this purpose, and is a valuable tool to assist the surgeon with
clinical decision-making. Commenters also pointed out that the non-
ophthalmic FVA procedure has been used primarily in the hospital
inpatient setting, and only recently offered in the hospital outpatient
setting; therefore, outpatient data are only beginning to accumulate.
However, commenters believed that because the ``Q2'' status indicator
will typically result in packaging the cost of the procedure, the
procedure will not be performed at many hospitals. The commenters
asserted that it was very important that CMS change the status
indicator of HCPCS code C9733 to ``S,'' which is the same status
indicator as all other procedures assigned to APC 0397. Moreover, some
commenters stated that other vascular imaging procedures, such as
Doppler Ultrasound, fluoroscopy, and magnetic resonance angiography
(MRA), are alternatives to the procedure described by HCPCS code C9733
and are assigned status indicator ``S'' rather than status indicator
``Q2.'' Another commenter noted that other modalities used for tissue
perfusion screening in the hospital outpatient setting are assigned to
APC 0096 (Level II Noninvasive Physiologic Studies), and these
procedures also are assigned status indicator ``S.'' The commenter
opined that assignment of status indicator ``Q2'' will encourage
outpatient clinics to schedule multiple
[[Page 68346]]
visits to avoid the packaging of HCPCS code C9733. One commenter
claimed that only a small number of APCs have more than one status
indicator for their assigned procedures, and that no other HCPCS C-
codes have a status indicator of ``Q2.'' The commenter asserted that
packaged status should only be assigned to procedures where data
indicate that the costs and services associated with the procedure are
integral to existing procedures.
One commenter asserted that the assignment of HCPCS code C9733 to
APC 0397 is not appropriate based on the costs of the procedure, and
estimated that the cost is approximately $2,100 per procedure. The
commenter stated that this estimate is based on a $6,000 monthly lease
payment of the system's capital with 5 times per month use, disposable
kit costs of approximately $800, plus $100 in indirect costs. The
commenter recommended the assignment of HCPCS code C9733 to APC 0279
(Level II Angiography and Venography), which has a CY 2013 proposed
payment rate of approximately $2,219, or assignment of the C-code to
New Technology APC 1522 (Level XXII New Technology), which has a CY
2013 proposed payment rate of $2,250, for at least a 3-year
transitional period, until the costs to perform the non-ophthalmic FVA
procedure are known, in order to package the procedure.
A few commenters were concerned that the HOP Panel, and perhaps CMS
as well, were confusing the HCPCS code C9733 technology with a ``Wood's
Lamp.'' The commenters explained the differences in the two
technologies, indicating that there are clinically significant
differences as a result of the properties of the fluorescent dyes with
which they are used.
Response: We believe that, when the non-ophthalmic FVA procedure is
performed with a surgical procedure, it is ancillary to the surgical
service, providing imaging services that are supportive and adjunctive
to the surgical service. As a number of commenters stated, the
procedure is used intraoperatively to assist the surgeon. In those
instances when the service described by HCPCS code C9733 is performed
as a stand-alone service, it is separately paid. Therefore, we believe
the ``Q2'' status indicator is appropriate. Regarding the comment that
there are only a few APCs that have more than one status indicator, we
assign status indicators to HCPCS codes, not to APCs. APCs are
sometimes composed of procedures that have similar roles in the overall
provision of services (for example, they are either major or minor
services, serve an adjunct role), but this is not always the case. We
disagree that the ``Q2'' status indicator will encourage multiple
clinic visits. In cases where surgery requires intraoperative imaging
to assess tissue perfusion, the procedure described by HCPCS code C9733
cannot be provided separate from the surgery. Regarding the estimated
cost of the procedure that a commenter provided, we note that the
assumptions regarding the use of the capital equipment markedly affects
the estimate of the cost of the procedure. The commenter's assumed use
of the equipment at 5 times per month, results in the $1,200 monthly
capital cost. However, an assumed monthly use of 20 times results in
$300 monthly costs, and 30 times per month results in $200 monthly
capital costs, and so on. Low utilization of a new technology can
result in aberrantly high per case cost estimates and illustrates why
it is important for us to wait until hospital outpatient claims data
become available to us for use in ratesetting. We understand the
differences between the non-ophthalmic FVA and Wood's Lamp
technologies, and assure the commenters that our decision is not based
on any confusion regarding the two technologies.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal to assign HCPCS code C9733 to APC 0397
and to continue to assign the code to status indicator ``Q2.'' APC 0397
has a CY 2013 final geometric mean cost of approximately $340, which we
note is a significant increase over the CY 2012 proposed rule mean
cost.
b. Level II Nervous System Imaging (APC 0402)
For CY 2013, we proposed to continue to assign CPT code 78607
(Brain imaging, tomographic (spect)) in APC 0402 (Level II Nervous
System Imaging), which had a proposed payment rate of approximately
$477.
Comment: Some commenters requested that CMS assess the accuracy of
the payment rate calculation for APC 0402. One commenter stated that
the proposed 22-percent payment reduction does not appear to be due to
any significant reduction in hospital charges for the procedures
included in the APC or the shift from the use of medical charges to the
use of the geometric mean cost. Another commenter requested that CMS
reassess its APC payment rate calculation, including the proposed
geometric mean cost of brain SPECT, which is described by CPT code
78607, and only phase in a change to the APC payment rate if the data
support a reduction.
Response: We reviewed our claims data and, for the CY 2013 update,
used more claims to determine the payment rate for APC 0402, as
compared to the CY 2012 update. For the CY 2012 final rule with comment
period, there were 2,593 single claims (out of 4,643 total claims),
while for the CY 2013 proposed rule, there were 3,062 single claims
(out of 4,793 total claims) used to calculate the proposed payment rate
for APC 0402. Also, as indicated in the file that we made available
with the proposed rule entitled ``CY 2013 OPPS Comparison Between
Proposed Geometric Mean and Median Based Payments,'' the proposed
payment rate using either payment methodology shows a decrease in the
payment rate for APC 0402 for the CY 2013 update. That is, the CY 2013
proposed payment rate for APC 0402, based on the median cost
methodology, was approximately $497, while the geometric mean cost
methodology resulted in a CY 2013 proposed payment rate of
approximately $477. While the proposed payment rate decreased for APC
0402, overall, the use of the geometric mean methodology has been
positive for many services. In addition, basing the OPPS payment
calculations on geometric means aligns the metric used in the
ratesetting methodology for the OPPS with that used for the IPPS.
Further examination of the claims data used for this final rule
with comment period revealed an increase in services assigned to APC
0402. Specifically, our claims data show a geometric mean cost of
approximately $472 based on 3,446 single claims (out of 5,345 total
claims). Similarly, we saw the same pattern of increase in services and
cost for CPT code 78607 from the proposed rule claims data to this
final rule claims data. That is, for the CY 2013 OPPS/ASC proposed
rule, the proposed geometric mean cost for CPT code 78607 was
approximately $490 based on 2,295 single claims (out of 2,573 total
claims), while the final rule geometric mean cost is approximately $468
based on 2,592 single claims (out of 2,902 total claims). We note that
CPT code 78607 represents 75 percent of the claims for services
assigned to APC 0402. Because of the robust claims, we believe that our
claims data accurately reflect the resource costs of the procedures
assigned to APC 0402, including the service described by CPT code
78607. We do not believe that applying a phase-in change to the APC
payment rate for the brain SPECT CPT code 78607 is necessary, given the
significant claims data for this procedure.
[[Page 68347]]
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT code 78607 to APC 0402. The final CY 2013 geometric mean
cost for APC 0402 is approximately $472.
c. Computed Tomography of Abdomen/Pelvis (APCs 0331 and 0334)
For CY 2011, the AMA's CPT Editorial Panel established three new
CPT codes to describe computed tomography of the abdomen and pelvis.
CPT codes 74176 (Computed tomography, abdomen and pelvis; without
contrast material), 74177 (Computed tomography, abdomen and pelvis;
with contrast material(s)), and 74178 (Computed tomography, abdomen and
pelvis; without contrast material in one or both body regions, followed
by contrast material(s) and further sections in one or both body
regions) were effective January 1, 2011. As shown in Table 26, for CY
2011, these services were paid under one of two methods under the OPPS.
They were either paid separately through a single APC or through a
composite APC. We assigned CPT code 74176 to APC 0332 (Computed
Tomography Without Contrast), CPT code 74177 to APC 0283 (Computed
Tomography With Contrast), and CPT code 74178 to APC 0333 (Computed
Tomography Without Contrast Followed By Contrast). We also assigned CPT
code 74176 to composite APC 8005 (CT and CTA Without Contrast
Composite), and CPT codes 74177 and 74178 to composite 8006 (CT and CTA
With Contrast Composite). We assigned the CPT codes to status indicator
``Q3'' to indicate that they were eligible for composite payment under
the multiple imaging composite APC methodology when they are furnished
with other computed tomography procedures performed on the same patient
on the same day.
[GRAPHIC] [TIFF OMITTED] TR15NO12.038
Consistent with our longstanding policy for new codes, in Addendum
B of the CY 2011 OPPS/ASC final rule with comment period, we assigned
these new CPT codes to interim APCs for CY 2011, with comment indicator
``NI'' to denote that the codes were new and the interim APC assignment
would be open to public comment. In accordance with our longstanding
policy to provide codes to enable payment to be made for new services
as soon as the code is effective, our interim APC assignment for each
code was based on our understanding of the resources required to
furnish the service and its clinical characteristics as defined in the
code descriptor.
As we described in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74259), in general, stakeholders who provided comments on
the interim APC assignments of these CPT codes for CY 2011 stated that
the most appropriate approach to establishing payment for these new
codes was to assign the procedures described by the codes to APCs that
recognize that each of the new codes reflects the reporting, under a
single code, of two services that were previously reported under two
separate codes and that, therefore, payments would be more accurate and
better reflective of the services under the OPPS than if we were to
establish payment rates for the codes for CY 2012 using claims data
that reflect the combined cost of the two predecessor codes. In
addition, at the February 28-March 1, 2011 Panel meeting, several
presenters expressed their concern and disagreement with our single APC
assignments for these new codes. The presenters stated that the payment
rates for the single APC assignments reflected only half of the true
costs of these services based on their internal calculated costs.
Similar to the public commenters, the presenters indicated that, prior
to CY 2011, these services were reported using a combination of codes,
and suggested that CMS revise the methodology to include these
combinations of codes to determine accurate payment rates for these
services. Specifically, the presenters indicated that simulating the
costs for CPT codes 74176, 74177, and 74178 using historical claims
data from the predecessor codes would result in the best estimates of
costs for these CPT codes and, therefore, the most accurate payment
rates.
After examination of our claims data for the predecessor codes, and
after considering the various concerns and recommendations that we
received on this issue (specifically, the views of the stakeholders who
met with us to discuss this issue, the comments received in response to
the CY 2011 OPPS/ASC final rule with public comment period, and input
from the Panel at its February 28-March 1, 2011 meeting), we proposed
to revise our payment methodology for CPT codes 74176, 74177, and 74178
for CY 2012 (76 FR 42235). That is, we proposed to simulate the costs
for CPT codes 74176, 74177, and 74178 using historical claims data from
the predecessor codes to determine the most accurate payment rates for
these CPT codes. This new proposed payment methodology necessitated
establishing two new APCs, specifically, APC 0331 (Combined Abdominal
and Pelvis CT Without Contrast) to which CPT code 74176 would be
assigned, and
[[Page 68348]]
APC 0334 (Combined Abdominal and Pelvis CT With Contrast) to which CPT
codes 74177 and 74178 would be assigned. In addition, we proposed to
continue to assign CPT code 74176 to composite APC 8005 and CPT codes
74177 and 74178 to composite APC 8006 for CY 2012.
Based on the feedback that we received from the Panel at its August
10-11, 2011 meeting, and the public comments received in response to
the CY 2012 OPPS/ASC proposed rule in support of the proposed revised
payment methodology for CPT codes 74176, 74177, and 74178, we finalized
our proposals in the CY 2012 OPPS/ASC final rule with comment period.
Specifically, we reassigned CPT code 74176 from APC 0332 to APC 0331,
CPT code 74177 from APC 0283 to APC 0334, and CPT code 74178 from APC
0333 to APC 0334. (We refer readers to the CY 2012 OPPS/ASC final rule
with comment period for a detailed description of the methodology we
used to simulate the costs of these procedures using claims data for
the predecessor CPT codes (76 FR 74259 through 74262).) We also
continued with our composite APC assignments for these codes.
Specifically, we continued to assign CPT code 74176 to composite APC
8005 and CPT codes 74177 and 74178 to composite APC 8006. Table 27
below shows the payment rates for these CPT codes for the CY 2012
update.
[GRAPHIC] [TIFF OMITTED] TR15NO12.039
We stated in the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74262) that we would reassess whether there is a continued need
for these APCs for the CY 2013 OPPS/ASC update once we have actual
charges for these services. Because CPT codes 74176, 74177, and 74178
became effective on January 1, 2011, we have hospital claims data
available for these codes that we can use for ratesetting for the first
time. In the CY 2013 OPPS/ASC proposed rule (77 FR 45086), we stated
that analysis of the latest CY 2011 hospital outpatient claims data for
the CY 2013 OPPS/ASC proposed rulemaking update, which was based on
claims processed with dates of service from January 1, 2011 through
December 31, 2011, revealed a decrease in costs for the three
procedures, compared to the costs simulated using the predecessor CPT
codes for CY 2012. CPT code 74176 showed a proposed geometric mean cost
of approximately $314 based on 312,493 single claims (out of 713,662
total claims), while CPT code 74177 showed a proposed geometric mean
cost of approximately $476 based on 367,002 single claims (out of
951,296 total claims). In addition, CPT code 74178 showed a proposed
geometric mean cost of approximately $537 based on 184,580 single
claims (out of 267,401 total claims). Because we used hospital claims
data specific to CPT codes 74176, 74177, and 74178, we stated that we
believe these costs accurately reflect the resources associated with
providing computed tomography of the abdomen and pelvis as described by
these CPT codes in the HOPD.
Furthermore, our analysis of the CY 2011 claims data available for
the proposed rule showed no 2 times rule violation for either APC 0331
or APC 0334. Therefore, for CY 2013, we proposed to continue to assign
CPT code 74176 to APC 0331 and CPT codes 74177 and 74178 to APC 0334.
(Because we have claims data available for these three CPT codes, we
will no longer simulate their costs using the predecessor codes as we
did in CY 2012.) In addition, we proposed to continue to assign these
codes to their existing composite APCs for CY 2013. Specifically, we
proposed to continue to assign CPT code 74176 to composite APC 8005,
and to assign CPT codes 74177 and 74178 to composite APC 8006.
Comment: Several commenters expressed concern with the decreased
payment rates for APCs 0331 and 0334, and suggested that the coding
changes that occurred in CY 2011 for CPT codes 74176, 74177, and 74178,
attributed to the payment reduction. Some of the commenters believed
that because the codes were new in CY 2011, hospitals have not had
enough time to appropriately adjust their charge masters to accurately
reflect the CY 2011 coding changes. One commenter urged CMS to take
whatever action necessary to mitigate the payment cuts for CY 2013.
Some of commenters requested that CMS delay the use of claims data and
continue the use of historical data for an additional year to give more
time for education and adjustment of hospital charge masters.
Response: We believe that hospitals have a process in place to
adjust to the numerous coding changes that occur annually. There are
hundreds of coding changes (that is, CPT, Level II Alphanumeric HCPCS,
and ICD-9-CM codes) that occur every year, and hospitals make changes
to their internal systems (for example, coding, charge masters,
grouper, business office systems, among other) accordingly to capture
these changes so that their claims are processed timely and accurately.
Because of the substantial claims data that we have for these
procedures, we see no reason to delay the use of the claims data in
determining the costs for
[[Page 68349]]
CPT codes 74176, 74177, and 74178. Specifically, we were able to use at
least 1 million claims that were submitted during CY 2011 in
determining the payment rates for CPT codes 74176, 74177, and 74178.
Our analysis for this final rule with comment period revealed a
geometric mean cost of approximately $315 for CPT code 74176 based on
333,144 single claims (out of 769,757 total claims), a geometric mean
cost of approximately $477 for CPT code 74177 based on 388,506 single
claims (out of 1,024,117 total claims), and a geometric mean cost of
approximately $538 for CPT code 74178 based on 194,216 single claims
(out of 283,435 total claims). We have no reason to believe that our
claims data, as reported by hospitals, do not accurately reflect the
hospital costs for CPT codes 74176, 74177 and 74178.
After consideration of the public comments received, we are
finalizing our CY 2013 proposal, without modification. Specifically,
for CY 2013, we are continuing to assign CPT code 74176 to APC 0331 and
CPT codes 74177 and 74178 to APC 0334. In addition, we are continuing
to assign these CPT codes to their existing composite APCs for CY 2013.
Specifically, we are continuing to assign CPT code 74176 to composite
APC 8005, and to assign CPT codes 74177 and 74178 to composite APC
8006.
Table 28 below lists the computed tomography of the abdomen and
pelvis CPT codes along with their status indicators, and single and
composite APC assignments for CY 2013.
[GRAPHIC] [TIFF OMITTED] TR15NO12.040
8. Respiratory Services
a. Bronchoscopy (APC 0415)
CPT code 31629 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; with transbronchial needle
aspiration biopsy(s), trachea, main stem and/or lobar bronchus(i)) was
established by the AMA's CPT Editorial Panel in 1987. CPT code 31634
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with balloon occlusion, with assessment of air leak, with
administration of occlusive substance (eg, fibrin glue), if performed)
was established effective January 1, 2011. CPT code 31629 has been
assigned to APC 0076 (Level I Endoscopy Lower Airway) since August
2000, when the hospital OPPS was implemented, while CPT code 31634 has
been assigned to APC 0076 since the code was effective on January 1,
2011.
In the CY 2013 OPPS/ASC proposed rule, we proposed to reassign both
CPT codes 31629 and 31634 from APC 0076 to APC 0415 (the Level II
Endoscopy Lower Airway). Consistent with CMS' policy of reviewing APC
assignments annually for any 2 times rule violations and
appropriateness of APC assignments based on the latest hospital
outpatient claims data, we evaluated the resource cost associated with
the procedures assigned to APC 0076 for the CY 2013 rulemaking update.
Based on our analysis, we determined that the configuration of APC 0076
violated the 2 times rule. To eliminate the 2 times rule violation, we
proposed to reassign CPT codes 31629 and 31634 from APC 0076 to APC
0415 because we believe this APC appropriately reflects these services
based on their resource costs as well as clinical homogeneity.
At the August 2012 HOP Panel meeting, a presenter requested that
the Panel recommend to CMS not to reassign CPT codes 31629 and 31634 to
APC 0415 for CY 2013. The presenter stated that including both
procedures in APC 0415 would result in a 2 times rule violation. In
addition, the presenter recommended that CPT codes 31629 and 31634 be
reassigned to APC 0074 (Level IV Endoscopy Upper Airway) instead of APC
0415. After discussion of the procedures and review of the hospital
outpatient claims and cost report data, the Panel recommended that CPT
codes 31629 and 31634 be reassigned from APC 0076 to APC 0415 for the
CY 2013 OPPS update.
Comment: Some commenters disagreed with the proposal to include CPT
codes 31629 and 31634 in APC 0415, and indicated that including both
procedures reduces the proposed payment rate for APC 0415 by at least
23 percent. One commenter specified that adding CPT codes 31629 and
31634, which have greater volumes of lower geometric mean costs than
other services assigned to APC 0415, reduces the overall payment of APC
0415. One commenter indicated that the reduction in payment would
hinder patient access to the pulmonary services listed under APC 0415
and recommended alternative endoscopy lower airway APC configurations,
such as establishing a new APC titled ``Level III Endoscopy Lower
Airway'' for six lower endoscopy procedures, that would include both
CPT codes 31629 and 31634 as well as four other lower endoscopy
procedures. Specifically, the commenter suggested including CPT codes
31626 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; with placement of fiducial markers, single or
multiple), 31631 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; with placement of tracheal
stent(s) (includes tracheal/bronchial dilation as required)), 31636
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with placement of bronchial stent(s) (includes tracheal/
bronchial dilation as required), initial bronchus), 31638
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with revision of tracheal or bronchial stent inserted at
previous session (includes tracheal/bronchial
[[Page 68350]]
dilation as required)), and CPT codes 31629 and 31634. The commenter
explained that CPT codes 31626, 31631, 31636, and 31638 are different
from other procedures assigned to APC 0415 because they require
implanting medical devices in the patient (fiducial markers, stents),
which results in extra cost. Another commenter requested that CMS
reevaluate the endoscopy lower airway APCs (0076 and 0415) as more
claims data become available for newer procedures, and to meet with
stakeholders to discuss the future reconfiguration of APCs for
endoscopy lower airway.
Response: As indicated above, we proposed to revise the APC
assignments for CPT codes 31629 and 31634 after our analysis of the
claims data for the CY 2013 rulemaking revealed a 2 times rule
violation in APC 0076. Based on the latest hospital outpatient claims
data for this final rule with comment period, we do not agree with the
commenters that we should implement an alternative configuration for
endoscopy lower airway APCs because the existing APCs are sufficient to
reflect the costs of all of the procedures assigned to these APCs. We
continue to believe that APC 0415 is the most appropriate APC
assignment for CPT codes 31629 and 31634 because their resource costs
are relatively similar to the procedures assigned to APC 0415.
Therefore, we are accepting the Panel's recommendation and will assign
both procedures to APC 0415. For the CY 2013 update, our analysis of
the claims data submitted during CY 2011 and used for this final rule
with comment period show a geometric mean cost of approximately $1,381
based on 2,699 single claims (out of 12,209 total claims) for CPT code
31629, and a relatively similar geometric mean cost of approximately
$1,394 for CPT code 31634 based on 10 single claims (out of 16 total
claims). Consistent with CMS' policy of reviewing APC assignments
annually, we will again reevaluate the clinical similarity and resource
use of the procedures in APC 0415 for the CY 2014 rulemaking cycle.
Finally, we note that we regularly accept meetings from interested
parties throughout the year, and we encourage stakeholders to continue
a dialogue with us during the rulemaking cycle and throughout the year
on this issue.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal, without modification, to reassign CPT
codes 31629 and 31634 from APC 0076 to APC 0415. The final CY 2013
geometric mean cost for APC 0415 is approximately $1,617.
b. Upper Airway Endoscopy (APC 0075)
For CY 2013, we proposed to continue to assign CPT codes 31295
(Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus
ostium (eg, balloon dilation), transnasal or via canine fossa;), 31296
(Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium
(eg, balloon dilation)), and 31297 (Nasal/sinus endoscopy, surgical;
with dilation of sphenoid sinus ostium (eg, balloon dilation)) to APC
0075 (Level V Endoscopy Upper Airway), which had a CY 2013 proposed
payment rate of approximately $2,039. In addition, we proposed to
reassign CPT code 31541 (Laryngoscopy, direct, operative, with excision
of tumor and/or stripping of vocal cords or epiglottis; with operating
microscope or telescope) from APC 0074 (Level IV Endoscopy Upper
Airway) to APC 0075.
Comment: Commenters objected to the assignment of CPT codes 31295,
31296, and 31297 to APC 0075 because the commenters believed that the
payment rate for APC 0075 substantially underpays providers. The
commenters recommended that CMS create split APCs for sinus surgery
with balloon catheter and without balloon catheter, the former of which
should be deemed device-dependent to appropriately account for the cost
of such procedures. The commenters also requested that CMS not finalize
its proposal to reassign CPT 31541 to APC 0075 and, instead, maintain
the code in APC 0074 for CY 2013.
Response: We believe that the most clinically appropriate APC
assignment for CPT codes 31295, 31296, and 31297 is APC 0075, which
includes other nasal and sinus endoscopy procedures. When assigning
procedures to an APC, we first consider the clinical and resource
characteristics of a procedure and determine the most appropriate APC
assignment. Regarding the resource costs of the procedures in question,
the commenters asserted costs of approximately $4,000 for these
procedures, which are currently assigned to the highest paying
clinically appropriate APC (APC 0075), which is Level 5 out of 5 levels
of APCs for ``endoscopy upper airway.'' The highest geometric mean cost
of all of the procedures assigned to APC 0075 is approximately $4,000.
Therefore, even the nonclaims data-based cost estimate for these
procedures offered by the commenters is within the approximate range
(although on the high end of the range) of the geometric mean costs for
procedures assigned to APC 0075. We do not agree with the commenters
that new APCs should be created to differentiate between sinus surgery
with balloon catheter and without balloon catheter, as APC 0075
accurately reflects a reasonable distribution of resource costs
reflected in the group of clinically similar services currently
assigned to the APC. We note that there is currently no 2 times rule
violation in APC 0075. We do not agree with the commenters that CPT
code 31541 should continue to be assigned to APC 0074, as CPT code
31541's geometric mean cost of approximately $1,962 is higher than the
geometric mean cost for any service currently assigned to APC 0074 and
would result in a 2 times rule violation for APC 0074 as well. We
believe that the geometric mean cost and clinical characteristics of
CPT code 31541 justify its assignment to APC 0075 for CY 2013.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposals, without modification, to continue to
assign CPT codes 31295, 31296, and 31297 to APC 0075, and reassign CPT
code 31541 to APC 0075, which has a final CY 2013 APC geometric mean
cost of approximately $2,085.
9. Other Services
a. Payment for Molecular Pathology Services
For the January 2012 update, the AMA's CPT Editorial Panel
established 101 new molecular pathology services CPT codes that were
designated as either Molecular Pathology Procedures Tier 1 or Molecular
Pathology Procedures Tier 2 effective January 1, 2012. Tier 1 consisted
of CPT codes 81200 through 81383, while Tier 2 consisted of CPT codes
81400 through 81408. However, these new molecular pathology CPT codes
are not valid for payment under Medicare for CY 2012.
Instead, molecular pathology tests for CY 2012 are billed using
combinations of longstanding CPT codes that describe each of the
various steps required to perform a given test. This billing method is
called ``stacking'' because different ``stacks'' of codes are billed
depending on the components of the furnished test. Currently, all of
the stacking codes are paid under the Clinical Laboratory Fee Schedule
(CLFS) and one stacking code, CPT code 83912 (Molecular diagnostics;
interpretation and report), is paid on both the CLFS and the Medicare
Physician Fee Schedule (MPFS). Payment for the interpretation and
report of a molecular pathology test when furnished and billed by a
physician is made under the MPFS using the professional component (PC,
or modifier ``26'') of CPT code 83912
[[Page 68351]]
(83912-26). Payment for the interpretation and report of a molecular
pathology test when furnished by nonphysician laboratory staff is made
under the CLFS using CPT code 83912. Thus, under Medicare, molecular
pathology services are paid under a fee schedule other than the OPPS.
In Addendum B of the CY 2012 OPPS/ASC final rule with comment
period, we assigned the 101 molecular pathology services CPT codes to
status indicator ``B'' to indicate that Medicare recognizes another
more specific HCPCS code for the service, as well as to comment
indicator ``NI'' to indicate that the CPT code was new for CY 2012 and
that public comments would be accepted on the interim APC assignment
for the new code, if applicable. We subsequently corrected the status
indicator assignment for these CPT codes from ``B'' to ``E'' to
indicate that they are not paid by Medicare in Addendum B of the CY
2012 OPPS/ASC final rule with comment period that was posted on the CMS
Web site. In the CY 2013 OPPS/ASC proposed rule, we proposed to
reassign the status indicator for the 101 molecular pathology services
CPT codes from ``E'' to ``A'' for CY 2013 to indicate that the codes
would be paid under a Medicare fee schedule and not under the OPPS. The
public comments that we received in response to the CY 2012 OPPS/ASC
final rule with comment period and the CY 2013 OPPS/ASC proposed rule
are addressed below.
Comment: One commenter to the CY 2012 OPPS/ASC final rule with
comment period requested that CMS consider paying separately for the
molecular pathology services under the OPPS, and recommended that CMS
reassign the services to status indicator ``X'' (Paid under OPPS;
separate APC payment).
Several commenters who responded to the CY 2013 OPPS/ASC proposed
rule requested clarification of the status indicator assignment and
payment status for the molecular pathology services. One commenter
indicated that CMS did not specify whether CPT codes 81200 through
81299, 81300 through 81383, and 81400 through 81408 will continue to be
assigned status indicator ``E'' under the OPPS.
Another commenter pointed out that CMS did not specifically discuss
the 101 molecular pathology services CPT codes in the CY 2013 OPPS/ASC
proposed rule, but did propose to assign status indicator ``A'' to the
new molecular pathology services CPT codes. The commenter believed that
CMS is unsure as to how these services will be paid, whether they will
be paid under the MPFS or under the CLFS. The commenter recommended
that CMS pay for the molecular pathology services codes under the MPFS
to cover the professional interpretation and work components, and under
the OPPS to cover the technical component of the services when provided
in a HOPD.
Response: Molecular pathology services are not paid under the OPPS.
As explained above, molecular pathology services currently are billed
using stacking codes that are paid under the CLFS with one stacking
code, specifically, CPT code 83912, being paid under both the CLFS and
the MPFS. For the CY 2013 update, the CPT ``stacking'' codes 83890
through 83914 will be deleted on December 31, 2012, and will be
replaced with 115 new molecular pathology CPT codes. Specifically, this
includes the 101 molecular pathology services CPT codes discussed above
plus an additional 14 new Tier I Molecular Pathology Procedure CPT
codes that the AMA's CPT Editorial Panel established effective January
1, 2013. In addition, CMS established one HCPCS G-code effective
January 1, 2013. With the exception of the HCPCS G-code, the 115
molecular pathology CPT codes will be paid under the CLFS. Payment for
the interpretation and report of a molecular pathology test when
furnished and billed by a physician will be made under the MPFS using
the professional component-only HCPCS code G0452 (Molecular pathology
procedure; physican interpretation and report). We refer readers to the
CY 2013 MPFS final rule with comment period for further information on
the molecular pathology services CPT codes.
Although we did not discuss this issue in the preamble of the CY
2013 OPPS/ASC proposed rule, we proposed to assign the 101 molecular
pathology services CPT codes to status indicator ``A'' for the CY 2013
update. Specifically, we assigned the 101 molecular pathology services
CPT codes to status indicator ``A'' in Addendum B to the proposed rule
(which is available via the Internet on the CMS Web site). We note that
HCPCS codes listed in Addenda A and B are subject to comment, and
responses to the comments received are addressed in the final rule with
comment period.
For CY 2013, the 101 molecular pathology services CPT codes will be
assigned to status indicator ``A'' because they will be paid under the
CLFS. Consistent with the OPPS assignment for the 101 molecular
pathology services, the 14 new CPT codes also will be assigned to
status indicator ``A'' for CY 2013. Specifically, CPT codes 81201
through 81203, 81235, 81252 through 81254, 81321 through 81326, and
81479 will be assigned to status indicator ``A'' because they will be
paid under the CLFS. In addition, HCPCS code G0452 will be assigned to
status indicator ``B'' to indicate that the HCPCS code describes a
professional component-only service that is paid under the MPFS.
In summary, after consideration of the public comments we received,
we are finalizing our proposal, without modification, to assign the 101
molecular pathology services CPT codes to status indicator ``A'' for CY
2013. Consistent with the OPPS assignment for the 101 molecular
pathology services, the 14 new CPT codes also will be assigned to
status indicator ``A'' for CY 2013. In addition, HCPCS code G0452 will
be assigned to status indicator ``B'' under the OPPS for the CY 2013
update.
b. Bone Marrow (APC 0112)
For CY 2013, we proposed to continue to assign CPT code 38240 (Bone
marrow or blood-derived peripheral stem cell transplantation;
allogeneic) and CPT code 38241 (Bone marrow or blood-derived peripheral
stem cell transplantation; autologous) to APC 0112 (Apheresis and Stem
Cell Procedures), which had a CY 2013 proposed payment rate of
approximately $2,878.
Comment: One commenter requested that CMS create separate APCs for
autologous and allogeneic transplants in recognition of the cost
difference between the two procedures. In addition, the commenter urged
CMS to develop an alternate ratesetting methodology for low volume
services or services performed by a small number of providers to more
accurately capture their costs.
Response: We believe that CPT codes 38240 and 38241 are both
appropriately assigned to APC 0112 based on clinical homogeneity. We
note that there is no 2 times rule violation in APC 0112; therefore, we
do not agree with the commenter's suggestion that we need to create
separate APCs for autologous and allogeneic transplants. We appreciate
the commenter's interest in developing an alternate ratesetting
methodology for low-volume services as we are always eager to find
improved methods to more accurately capture costs of services performed
in the hospital outpatient setting.
After consideration of the public comment we received, we are
finalizing our CY 2013 proposal, without modification, to continue to
assign CPT codes 38240 and 38241 to APC 0112,
[[Page 68352]]
which has a final CY 2013 APC geometric mean cost of approximately
$2,972.
IV. OPPS Payment for Devices
A. Pass-Through Payments for Devices
1. Expiration of Transitional Pass-Through Payments for Certain Devices
a. Background
Section 1833(t)(6)(B)(iii) of the Act requires that, under the
OPPS, a category of devices be eligible for transitional pass-through
payments for at least 2, but not more than 3 years. This pass-through
payment eligibility period begins with the first date on which
transitional pass-through payments may be made for any medical device
that is described by the category. We may establish a new device
category for pass-through payment in any quarter. Under our established
policy, we base the pass-through status expiration date for a device
category on the date on which pass-through payment is effective for the
category, which is the first date on which pass-through payment may be
made for any medical device that is described by such category. We
propose and finalize the dates for expiration of pass-through status
for device categories as part of the OPPS annual update.
We also have an established policy to package the costs of the
devices that are no longer eligible for pass-through payments into the
costs of the procedures with which the devices are reported in the
claims data used to set the payment rates (67 FR 66763). Brachytherapy
sources, which are now separately paid in accordance with section
1833(t)(2)(H) of the Act, are an exception to this established policy.
There currently are four device categories eligible for pass-
through payment. These device categories are described by HCPCS code
C1749 (Endoscope, retrograde imaging/illumination colonoscope device
(implantable)), which we made effective for pass-through payment
October 1, 2010; HCPCS codes C1830 (Powered bone marrow biopsy needle)
and C1840 (Lens, intraocular (telescopic)), which we made effective for
pass-through payment October 1, 2011; and HCPCS code C1886 (Catheter,
extravascular tissue ablation, any modality (insertable)), which we
made effective for pass-through payment January 1, 2012. In the CY 2012
OPPS/ASC final rule with comment period, we finalized the expiration of
pass-through payment for HCPCS code C1749, which will expire after
December 31, 2012 (76 FR 74278). Therefore, after December 31, 2012, we
will package the costs of the HCPCS code C1749 device into the costs of
the procedures with which the devices are reported in the hospital
claims data used in OPPS ratesetting.
b. CY 2013 Policy
As stated above, section 1833(t)(6)(B)(iii) of the Act requires
that, under the OPPS, a category of devices be eligible for
transitional pass-through payments for at least 2, but not more than 3
years. Device pass-through categories C1830 and C1840 were established
for pass-through payments on October 1, 2011, and will have been
eligible for pass-through payments for more than 2 years but less than
3 years as of the end of CY 2013. Also, device pass-through category
C1886 was established for pass-through payments on January 1, 2012, and
will have been eligible for pass-through payments for at least 2 years
but less than 3 years as of the end of CY 2013. Therefore, in the CY
2013 OPPS/ASC proposed rule (77 FR 45125), we proposed a pass-through
payment expiration date for device categories C1830, C1840, and C1886
of December 31, 2013. Under our proposal, beginning January 1, 2014,
device categories C1830, C1840, and C1886 will no longer be eligible
for pass-through payments, and their respective device costs would be
packaged into the costs of the procedures with which the devices are
reported in the claims data.
Comment: One commenter expressed concern that under the CMS
proposal to expire device HCPCS code C1886 from pass-through payment,
CMS will have difficulty in establishing a payment rate that will
reflect all costs associated with bronchial thermoplasty, the procedure
with which the HCPCS code C1886 device is used. The commenter indicated
that the two bronchial thermoplasty codes, CPT code 0276T
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with bronchial thermoplasty, 1 lobe) and CPT code 0277T
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with bronchial thermoplasty, 2 or more lobes) are subject to
noncoverage policies for all Category III CPT codes for all but two
MACs, resulting in few Medicare claims for CY 2012, the year for which
CPT codes 0276T and 0277T are reported for bronchial thermoplasty, and
which will be used for CY 2014 ratesetting. The commenter estimated
that there are nine Medicare claims for bronchial thermoplasty in CY
2011, available for CY 2013 ratesetting, which were billed with HCPCS
codes C9730 and C9731. The commenter requested that CMS delay the
expiration of pass-through status for HCPCS code C1886 because of
limited data available for CY 2014 ratesetting, and because two
Category 1 CPT codes related to bronchial thermoplasty are expected to
become effective January 1, 2013, which would result in these
procedures being removed from the MAC local coverage determinations for
noncovered services.
Response: We created HCPCS code C1886 as a new device category
effective January 1, 2012. As such, there are no claims for HCPCS code
C1886 in our CY 2011 claims data. However, although we have no claims
data for CY 2011, we have over 300 units of HCPCS code C1886 reported
in the first 8 months of CY 2012, with robust cost data. Therefore, we
believe that we will have sufficient CY 2012 claims on which to base
payment rates for the bronchial thermoplasty procedures with which
HCPCS code C1886 is billed.
After consideration of the public comment we received, we are
finalizing our proposal to expire from pass-through payment HCPCS C1886
on December 31, 2013, and to package its costs with the costs of the
procedures with which it is billed.
We did not receive any public comments regarding our proposals to
expire pass-through payment eligibility for device categories C1830 and
C1840 and to package their respective costs into the costs of the
procedures with which the devices are reported. Therefore, we are
finalizing our proposals to expire from pass-through payment these
device categories, and to package their costs with the costs of the
procedures with which they are billed.
We also received a number of comments related to packaging the
costs of HCPCS code C1749 into the costs of the procedures with which
the HCPCS code C1749 device are reported, a policy we finalized in the
CY 2012 OPPS/ASC final rule with comment period (76 FR 74278). We are
discussing these public comments in this section instead of the section
on packaging because of their relationship to device pass-through
payment.
Comment: A few commenters asserted that packaging payment for the
HCPCS code C1749 device (retrograde colonoscope or Third Eye
Retroscope) into the costs of colonoscopy procedure codes, with which
it is billed, after the period of pass-through payment ends on December
31, 2012, will not provide adequate payment for use of the device.
One commenter based this assertion on a study of CY 2011 Medicare
claims data (which the commenter summarized in its comment letter) for
7 diagnostic colonoscopy procedures found in APC
[[Page 68353]]
0143 (Lower GI endoscopy) performed with HCPCS code C1749, finding that
the weighted geometric mean costs of procedures in which HCPCS code
C1749 was used is approximately $969; the cost of the same 7
colonoscopy procedures without HCPCS code C1749 is approximately $437,
showing a cost difference of approximately $532, which it attributed to
the cost of the HCPCS code C1749 device. At the same time, the
commenter pointed out that it identified 688 claims for these 7
colonoscopy procedure codes that included units of HCPCS code C1749,
while there were 1,067,828 claims for the same 7 procedure codes that
did not include HCPCS code C1749 on the claim, or only 0.064 percent of
the total claims for these 7 codes that included HCPCS code C1749.
Therefore, the commenter claimed that the proposed rates for existing
colonoscopy procedures do not fairly reflect the costs of HCPCS code
C1749. The commenter further asserted that the proposed APC 0143
payment rate of $691.58 would not pay hospitals adequately for the cost
of a procedure using the HCPCS code C1749 device. The commenter claimed
that the payment shortfall would be even greater in the ASC setting,
where the proposed payment rate for colonoscopies is $389.60. The
commenter requested that CMS create a G-code (entitled ``colonoscopy,
flexible, proximal to splenic flexure; with continuous retrograde
examination'') to be billed along with existing colonoscopy procedure
codes when using the HCPCS code C1749 device; assign the new G-code and
its costs to a unique device dependent APC under the OPPS and a device-
intensive APC under the ASC payment system; and require that HCPCS code
C1749 be billed with the new G-code.
Some commenters suggested that CMS continue to pay for HCPCS code
C1749 separately, based on OPPS claims data, from the APC payment for
the procedure under a unique device-dependent APC in the OPPS and a
device-intensive APC for ASC payment because the HCPCS code C1749
device represents the primary cost of this procedure. Another commenter
requested that CMS extend the pass-through payment for HCPCS code C1749
through CY 2013 to help further data collection for the device
regarding its clinical role and to ensure access to the device for
endoscopists' use.
A number of commenters, including those who were patients or
relatives of patients, emphasized the importance of being examined by
the Third Eye Retroscope, the device upon which HCPCS code C1749 is
based, because it provides dramatically improved detection rates of
pre-cancerous adenomas, and urged CMS to improve payment for the HCPCS
code C1749 procedure. Several commenters claimed that the proposal did
not provide a code or payment to report use of the HCPCS code C1749
device.
Response: HCPCS code C1749 was created for device pass-through
payment of the retrograde colonoscope effective October 1, 2010. Under
the statute, hospitals are paid for devices eligible for pass-through
payment, which is payment for the device in addition to the usual APC
payment rate, for at least 2 but not more than 3 years from the date we
establish pass-through payment. We finalized the expiration of pass-
through payment eligibility for HCPCS code C1749 on December 31, 2012,
and, consistent with our normal ratesetting methodology for expired
device pass-through payment, we finalized in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74278) our policy to package the costs
of the HCPCS code C1749 device with the procedures with which it is
billed, effective January 1, 2013 (76 FR 74278). For CY 2013, there are
692 units of HCPCS code C1749 reported in our CY 2011 OPPS claims data,
with a geometric mean cost of approximately $536. For CY 2013, these
costs would be packaged into the procedures with which HCPCS code C1749
are billed. CY 2011 was the first complete year that HCPCS code C1749
was effective, and we assume that utilization of this new device will
grow over time.
We do not agree with the commenter that using the HCPCS code C1749
retrograde colonoscope during a colonoscopy is a separate procedure,
and therefore would require a G-code to describe a separate procedure.
We believe that the retrograde colonoscopic portion of the procedure
entails a small incremental amount of colonoscopy procedure time, as it
is primarily used during withdrawal of the colonoscope, and there are
few additional resource costs (such as procedure room time, equipment
costs) other than the HCPCS code C1749 device itself, according to the
commenter in its study of the 7 colonoscopy procedure codes. Therefore,
the retrograde portion of the procedure is not a separate procedure on
which to base a new G-code. Therefore, we will package costs for HCPCS
code C1749 with the colonoscopic procedures with which they are billed
according to our standard policy. Because we are declining to create a
G-code to describe the retrograde colonoscopic portion of colonoscopy
procedures, there is no need to create a new, dedicated device-
dependent APC, as requested by the commenter.
We also do not agree with the commenter's alternate suggestion that
separate payment is needed for HCPCS code C1749 at this time. HCPCS
code C1749 is currently under separate payment under the pass-through
provision, and once pass-through status expires, device costs are
packaged into the payment for the procedure.
Regarding the commenter's request that we extend the eligibility
for pass-through payment of HCPCS code C1749 through CY 2013, based on
the statutory limits at section 1833(t)(6)(B)(iii) of the Act and
related payment policies not permitting partial year rate changes, we
are not able to further extend pass-through payment for HCPCS code
C1749. Moreover, we will be able to track the HCPCS code C1886 device
utilization in CY 2013 even without the pass-through payment
eligibility because HCPCS code C1749 will still be required to be
reported with the procedures with which it is billed.
The commenters who believe that HCPCS codes for pass-through
devices become inactive when pass-through status for a device expires
are incorrect. Under our longstanding policy, once the period of device
pass-through payment is complete, we package the costs of the devices
with the procedures with which they are billed. In the case of HCPCS
code C1749, as stated previously, it is our proposal to package the
device costs with the colonoscopy procedures with which the retrograde
colonoscope is billed, effective January 1, 2013, to maintain HCPCS
code C1749 for the device, and to require hospitals to include HCPCS
code C1749 and its costs on the claims for the procedures with which it
is billed. This will provide assurance that the costs of HCPCS code
C1749 will be represented in our claims data and accounted for in the
relevant APC payment rates.
After consideration of the public comments we received, we are
finalizing our proposals concerning the expiration for pass-through
payment eligibility for device category codes C1830, C1840, and C1886
as of December 31, 2013, and to package the device costs with the
respective procedures with which these devices are billed. Furthermore,
we are maintaining our previous decision to package the costs of HCPCS
code C1749 with the procedures with which it is billed, as of January
1, 2013.
[[Page 68354]]
2. Provisions for Reducing Transitional Pass-through Payments To Offset
Costs Packaged Into APC Groups
a. Background
Section 1833(t)(6)(D)(ii) of the Act sets the amount of additional
pass-through payment for an eligible device as the amount by which the
hospital's charges for a device, adjusted to cost (cost of device)
exceeds the portion of the otherwise applicable Medicare outpatient
department fee schedule amount (APC payment amount) associated with the
device. We have an established policy to estimate the portion of each
APC payment rate that could reasonably be attributed to the cost of the
associated devices that are eligible for pass-through payments (66 FR
59904) for purposes of estimating the portion of the otherwise
applicable APC payment amount associated with the device. For eligible
device categories, we deduct an amount that reflects the portion of the
APC payment amount that we determine is associated with the cost of the
device, defined as the device APC offset amount, from the charges
adjusted to cost for the device, as provided by section
1833(t)(6)(D)(ii) of the Act, to determine the eligible device's pass-
through payment amount. We have consistently employed an established
methodology to estimate the portion of each APC payment rate that could
reasonably be attributed to the cost of an associated device eligible
for pass-through payment, using claims data from the period used for
the most recent recalibration of the APC rates (72 FR 66751 through
66752). We establish and update the applicable device APC offset
amounts for eligible pass-through device categories through the
transmittals that implement the quarterly OPPS updates.
We currently have published a list of all procedural APCs with the
CY 2012 portions (both percentages and dollar amounts) of the APC
payment amounts that we determine are associated with the cost of
devices on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. The dollar
amounts are used as the device APC offset amounts. In addition, in
accordance with our established practice, the device APC offset amounts
in a related APC are used in order to evaluate whether the cost of a
device in an application for a new device category for pass-through
payment is not insignificant in relation to the APC payment amount for
the service related to the category of devices, as specified in our
regulations at Sec. 419.66(d).
Beginning in CY 2010, we include packaged costs related to
implantable biologicals in the device offset calculations in accordance
with our policy that the pass-through evaluation process and payment
methodology for implantable biologicals that are surgically inserted or
implanted (through a surgical incision or a natural orifice) and that
are newly approved for pass-through status beginning on or after
January 1, 2010, be the device pass-through process and payment
methodology only (74 FR 60476).
b. CY 2013 Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45125), we proposed to
continue, for CY 2013, our established methodology to estimate the
portion of each APC payment rate that could reasonably be attributed to
(that is, reflect) the cost of an associated device eligible for pass-
through payment, using claims data from the period used for the most
recent recalibration of the APC rates. We proposed to continue our
policy, for CY 2013, that the pass-through evaluation process and pass-
through payment methodology for implantable biologicals that are
surgically inserted or implanted (through a surgical incision or a
natural orifice) and that are newly approved for pass-through status
beginning on or after January 1, 2010, be the device pass-through
process and payment methodology only. The rationale for this policy is
provided in the CY 2010 OPPS/ASC final rule with comment period (74 FR
60471 through 60477). We also proposed to continue our established
policies for calculating and setting the device APC offset amounts for
each device category eligible for pass-through payment. In addition, we
proposed to continue to review each new device category on a case-by-
case basis to determine whether device costs associated with the new
category are already packaged into the existing APC structure. If
device costs packaged into the existing APC structure are associated
with the new category, we proposed to deduct the device APC offset
amount from the pass-through payment for the device category. As stated
earlier, these device APC offset amounts also would be used in order to
evaluate whether the cost of a device in an application for a new
device category for pass-through payment is not insignificant in
relation to the APC payment amount for the service related to the
category of devices (Sec. 419.66(d)).
For CY 2013, we also proposed to continue our policy established in
CY 2010 to include implantable biologicals in our calculation of the
device APC offset amounts. In addition, we proposed to continue to
calculate and set any device APC offset amount for a new device pass-
through category that includes a newly eligible implantable biological
beginning in CY 2013 using the same methodology we have historically
used to calculate and set device APC offset amounts for device
categories eligible for pass-through payment, and to include the costs
of implantable biologicals in the calculation of the device APC offset
amounts.
In addition, we proposed to update, on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html the list of all procedural APCs with
the final CY 2013 portions of the APC payment amounts that we determine
are associated with the cost of devices so that this information is
available for use by the public in developing potential CY 2013 device
pass-through payment applications and by CMS in reviewing those
applications.
Comment: One commenter recommended that all biologicals, including
implantable biologicals that are approved by the FDA under biological
license applications (BLAs), be treated as drugs, rather than as
devices, for pass-through payment purposes for CY 2013. The commenter
claimed that when Congress enacted the current payment system for SCODs
that previously had pass-through status, it intended for biologicals
approved under BLAs to be paid under the specific statutory provisions
for drugs. The commenter argued that it is only logical, then, that
Congress would have intended for these BLA-approved therapies to be
paid as pass-through drugs as well. The commenter requested that, if
CMS continues to evaluate implantable biologicals under the pass-
through device criteria, CMS clarify its policy that the device pass-
through criteria apply only to biologicals if they are solely
surgically implanted according to their FDA approved indications. The
commenter stated that the current regulation at 42 CFR 419.64(a)(4) is
unclear how we would evaluate pass-through eligibility of a biological
that has both surgically implanted and nonimplantable indications. The
commenter stated that the explanation CMS provided in the CY 2012 OPPS/
ASC final rule with comment period, that ``we mean to exclude from
consideration for drug and biological pass-through status any
biological that has an indication such that it may function as a
surgically implanted or inserted biological, even if there are also
indications in which the
[[Page 68355]]
biological is not surgically implanted or inserted'' (76 FR 74280), is
unclear and inconsistent with what CMS has stated previously in policy
and billing instructions. The commenter recommended that CMS revise the
regulation text so that if refers to ``a biological that is not always
surgically implanted into the body.''
Response: As stated in previous OPPS/ASC final rules with comment
period, we evaluate implantable biologicals that function as, and are
substitutes for, implantable devices for OPPS payment purposes. This is
done regardless of their category of FDA approval (74 FR 60476; 75 FR
71924; 76 FR 74279 through 74280). We do not believe it is necessary to
make our OPPS payment policies regarding implantable biologicals
dependent on categories of FDA approval, the intent of which is to
ensure the safety and effectiveness of medical products.
We do not agree with the commenter who asserted that Congress
intended biologicals approved under BLAs to be paid under the specific
OPPS statutory provisions that apply to SCODs, including the pass-
through provisions. Moreover, as we stated in previous OPPS/ASC final
rules with comment period, Congress did not specify in the statute that
we must pay for implantable biologicals as biologicals rather than
devices, if they also meet our criteria for payment as a device (74 FR
60476; 75 FR 71924; and 76 FR 74280). We continue to believe that
implantable biologicals meet both the definitions of a device and a
biological and that, for payment purposes, it is appropriate for us to
consider implantable biologicals as implantable devices in all cases,
and not as biologicals.
We do not agree with the commenter's assertion that the explanation
offered in the CY 2012 OPPS/ASC final rule with comment period of the
regulation text at 42 CFR 419.64(a)(4)(iii) which indicates that a
biological for drug pass-through payment purposes must not be
surgically implanted or inserted into the body, is inconsistent with
our prior description of this policy, the application of this policy to
date, and billing instruction to hospitals. Our policy and application
process have consistently reflected that implantable biologicals are
subject to the device application process since the beginning of CY
2010. For CYs 2010, 2011, and 2012, we finalized the same policy that
the pass-through evaluation process and payment methodology for
implantable biologicals that are surgically inserted or implanted
(through a surgical incision or a natural orifice), and that are newly
approved for pass-through status as of January 1, 2010, be the device
pass-through process and payment methodology only (74 FR 60476, 75 FR
71924, and 76 FR 74280, respectively). We have not established a policy
in any year that stated that implantable biologicals needed to be
solely surgically inserted or implanted to be subject to the device
pass-through process and payment methodology. Furthermore, there is no
inconsistency with our policy and billing instructions regarding pass-
through devices or implantable biologicals because there are no billing
instructions regarding the device pass-through application process.
Rather, application instructions are found on the CMS Web site
(currently at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/catapp.pdf). The language on
the device application web site is consistent with the language in the
CYs 2010, 2011, and 2012 final rules with comment period, stating that,
as of January 1, 2010, implantable biologicals that are surgically
inserted or implanted (through a surgical incision or natural orifice)
are being evaluated for device pass-through payment under the
instructions using the device pass-through process. We reiterate our
explanation provided in the CY 2012 final rule with comment period (76
FR 74280) regarding the regulatory language at 42 CFR 419.64(a)(4),
that we mean to exclude from consideration for drug and biological
pass-through status any biological that has an indication such that it
may function as a surgically implanted or inserted biological, even if
there also are indications in which the biological is not surgically
implanted or inserted. We will add similar language to our device and
drug pass-through application Web sites as well.
We are finalizing the following proposals for CY 2013: to continue
our established methodology to estimate the portion of each APC payment
rate that could reasonably reflect the cost of an associated device
eligible for pass-through payment; to continue our policy that the
pass-through evaluation process and pass-through payment methodology
for implantable biologicals that are surgically inserted or implanted
(through a surgical incision or a natural orifice) and that are newly
approved for pass-through status beginning on or after January 1, 2010,
be the device pass-through process and payment methodology only; to
continue our established policies for calculating and setting the
device APC offset amounts for each device category eligible for pass-
through payment; and to continue to review each new device category on
a case-by-case basis to determine whether device costs associated with
the new category are already packaged into the existing APC structure,
and, if device costs packaged into the existing APC structure are
associated with the new category, to deduct the device APC offset
amount from the pass-through payment for the device category.
For CY 2013, we also are finalizing our proposal and continuing our
policy established in CY 2010 to include implantable biologicals in our
calculation of the device APC offset amounts, and to continue to
calculate and set any device APC offset amount for a new device pass-
through category that includes a newly eligible implantable biological
beginning in CY 2013 using the same methodology we have historically
used to calculate and set device APC offset amounts for device
categories eligible for pass-through payment, and to include the costs
of implantable biologicals in the calculation of the device APC offset
amounts.
In addition, we will update, on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html the list of all procedural APCs with
the final CY 2013 portions of the APC payment amounts that we determine
are associated with the cost of devices so that this information is
available for use by the public in developing potential CY 2013 device
pass-through payment applications and by CMS in reviewing those
applications.
3. Clarification of Existing Device Category Criterion
a. Background
Section 1833(t)(6)(B)(ii)(IV) of the Act directs the Secretary to
establish a new device category for pass-through payment for which none
of the pass-through categories in effect (or that were previously in
effect) is appropriate. Commenters who responded to our various
proposed rules, as well as applicants for new device categories, had
expressed concern that some of our existing and previously in effect
device category descriptors were overly broad, and that the device
category descriptors as they are currently written may preclude some
new technologies from qualifying for establishment of a new device
category for pass-through payment (70 FR 68630 through 68631). As a
result of these comments, we finalized a policy, effective January 1,
2006, to create an additional category for devices that meet all of the
criteria required to establish a new category for
[[Page 68356]]
pass-through payment in instances where we believe that an existing or
previously in effect category descriptor does not appropriately
describe the new device. Accordingly, effective January 1, 2006, we
revised Sec. 419.66(c)(1) of the regulations to reflect this policy
change. In order to determine if a new device is appropriately
described by any existing or previously in effect category of devices,
we apply two tests based upon our evaluation of information provided to
us in the device category application. First, an applicant for a new
device category must show that its device is not similar to devices
(including related predicate devices) whose costs are reflected in the
currently available OPPS claims data in the most recent OPPS update.
Second, an applicant must demonstrate that utilization of its device
provides a substantial clinical improvement for Medicare beneficiaries
compared with currently available treatments, including procedures
utilizing devices in any existing or previously in effect device
categories. We consider a new device that meets both of these tests not
to be appropriately described by any existing or previously in effect
pass-through device categories (70 FR 68630 through 68631).
b. Clarification of CY 2013 Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45126), we proposed,
for CY 2013, to clarify the test that requires an applicant for a new
device category to show that its device is not similar to devices
(including related predicate devices) whose costs are reflected in the
currently available OPPS claims data in the most recent OPPS update. We
clarified that this test includes showing that a new device is not
similar to predicate devices that once belonged in any existing or
previously in effect pass-through device categories. Under this test, a
candidate device may not be considered to be appropriately described by
any existing or previously in effect pass-through device categories if
the applicant adequately demonstrates that the candidate device is not
similar to devices (including related predicate devices) that belong or
once belonged to an existing or any previously in effect device
category, and that the candidate device is not similar to devices whose
costs are reflected in the OPPS claims data in the most recent OPPS
update. The substantial clinical improvement criterion, which also must
be satisfied in every case, as indicated in Sec. 419.66(c)(2) of our
regulations, is separate from the criterion that a candidate device not
be similar to devices in any existing or previously in effect pass-
through categories. We invited public comments regarding this proposed
clarification.
We did not receive any public comments on our proposal to clarify
the test that requires an applicant for a new device category to show
that its device is not similar to devices (including related predicate
devices) whose costs are reflected in the currently available OPPS
claims data. Therefore, we are clarifying our existing policy as noted
above.
B. Adjustment to OPPS Payment for No Cost/Full Credit and Partial
Credit Devices
1. Background
To ensure equitable payment when the hospital receives a device
without cost or with full credit, in CY 2007, we implemented a policy
to reduce the payment for specified device-dependent APCs by the
estimated portion of the APC payment attributable to device costs (that
is, the device offset) when the hospital receives a specified device at
no cost or with full credit (71 FR 68071 through 68077). Hospitals are
instructed to report no cost/full credit cases using the ``FB''
modifier on the line with the procedure code in which the no cost/full
credit device is used. In cases in which the device is furnished
without cost or with full credit, the hospital is instructed to report
a token device charge of less than $1.01. In cases in which the device
being inserted is an upgrade (either of the same type of device or to a
different type of device) with a full credit for the device being
replaced, the hospital is instructed to report as the device charge the
difference between its usual charge for the device being implanted and
its usual charge for the device for which it received full credit. In
CY 2008, we expanded this payment adjustment policy to include cases in
which hospitals receive partial credit of 50 percent or more of the
cost of a specified device. Hospitals are instructed to append the
``FC'' modifier to the procedure code that reports the service provided
to furnish the device when they receive a partial credit of 50 percent
or more of the cost of the new device. We refer readers to the CY 2008
OPPS/ASC final rule with comment period for more background information
on the ``FB'' and ``FC'' payment adjustment policies (72 FR 66743
through 66749).
2. APCs and Devices Subject to the Adjustment Policy
In the CY 2013 OPPS/ASC proposed rule (77 FR 45126), we proposed,
for CY 2013, to continue the existing policy of reducing OPPS payment
for specified APCs by 100 percent of the device offset amount when a
hospital furnishes a specified device without cost or with a full
credit and by 50 percent of the device offset amount when the hospital
receives partial credit in the amount of 50 percent or more of the cost
for the specified device. (We refer readers to section II.A.2.d.(1) of
this final rule with comment period for a description of our standard
ratesetting methodology for device-dependent APCs.)
For CY 2013, we also proposed to continue using the three criteria
established in the CY 2007 OPPS/ASC final rule with comment period for
determining the APCs to which this policy applies (71 FR 68072 through
68077). Specifically: (1) All procedures assigned to the selected APCs
must involve implantable devices that would be reported if device
insertion procedures were performed; (2) the required devices must be
surgically inserted or implanted devices that remain in the patient's
body after the conclusion of the procedure (at least temporarily); and
(3) the device offset amount must be significant, which, for purposes
of this policy, is defined as exceeding 40 percent of the APC cost. We
also proposed to continue to restrict the devices to which the APC
payment adjustment would apply to a specific set of costly devices to
ensure that the adjustment would not be triggered by the implantation
of an inexpensive device whose cost would not constitute a significant
proportion of the total payment rate for an APC. We stated in the CY
2013 OPPS/ASC proposed rule (77 FR 45127) that we continue to believe
these criteria are appropriate because free devices and device credits
are likely to be associated with particular cases only when the device
must be reported on the claim and is of a type that is implanted and
remains in the body when the beneficiary leaves the hospital. We
believe that the reduction in payment is appropriate only when the cost
of the device is a significant part of the total cost of the APC into
which the device cost is packaged, and that the 40-percent threshold is
a reasonable definition of a significant cost.
As indicated in the CY 2013 OPPS/ASC proposed rule (77 FR 45127),
we examined the offset amounts calculated from the CY 2013 proposed
rule data and the clinical characteristics of APCs to determine whether
the APCs to which the no cost/full credit and partial credit device
adjustment policy applied in CY 2012 continue to meet the criteria for
CY 2013, and to determine whether
[[Page 68357]]
other APCs to which the policy did not apply in CY 2012 would meet the
criteria for CY 2013. Based on the CY 2011 claims data available for
the proposed rule, we did not propose any changes to the APCs and
devices to which this policy applies.
Table 20 of the CY 2013 OPPS/ASC proposed rule (77 FR 45127) listed
the proposed APCs to which the payment adjustment policy for no cost/
full credit and partial credit devices would apply in CY 2013, and
displayed the proposed payment adjustment percentages for both no cost/
full credit and partial credit circumstances. We proposed that the no
cost/full credit adjustment for each APC to which this policy would
continue to apply would be the device offset percentage for the APC
(the estimated percentage of the APC cost that is attributable to the
device costs that are already packaged into the APC). We also proposed
that the partial credit device adjustment for each APC would continue
to be 50 percent of the no cost/full credit adjustment for the APC.
Table 21 of the CY 2013 OPPS/ASC proposed rule (77 FR 45128) listed
the proposed devices to which the payment adjustment policy for no
cost/full credit and partial credit devices would apply in CY 2013. We
stated in the CY 2013 proposed rule (77 FR 45127) that we would update
the lists of APCs and devices to which the no cost/full credit and
partial credit device adjustment policy would apply for CY 2013,
consistent with the three criteria discussed earlier in this section,
based on the final CY 2011 claims data available for the CY 2013 OPPS/
ASC final rule with comment period. The updated lists of APCs and
devices appear below in Table 29 and Table 30, respectively, of this
final rule with comment period. We note that there are no changes to
the lists of APCs and devices compared to the proposed rule for CY
2013.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45127), we proposed,
for CY 2013, that OPPS payments for implantation procedures to which
the ``FB'' modifier is appended are reduced by 100 percent of the
device offset for no cost/full credit cases when both a device code
listed in Table 21 of the proposed rule is present on the claim, and
the procedure code maps to an APC listed in Table 20 of the proposed
rule. We also proposed that OPPS payments for implantation procedures
to which the ``FC'' modifier is appended are reduced by 50 percent of
the device offset when both a device code listed in Table 21 of the
proposed rule is present on the claim and the procedure code maps to an
APC listed in Table 20 of the proposed rule. Beneficiary copayment is
based on the reduced amount when either the ``FB'' modifier or the
``FC'' modifier is billed and the procedure and device codes appear on
the lists of procedures and devices to which this policy applies.
Comment: Commenters reported that there are some instances in which
the hospital receives a full credit for only one component of a
pacemaker or ICD replacement procedure that involves both a lead and a
generator. Specifically, the commenters noted that the 2012 CPT Code
Book states that when a pulse generator insertion involves the
insertion or replacement of one or more lead(s), use system CPT codes
33206 (Insertion of new or replacement of permanent pacemaker with
transvenous electrode(s); atrial), 33207 (Insertion of new or
replacement of permanent pacemaker with transvenous electrode(s);
ventricular), and 33208 (Insertion of new or replacement of permanent
pacemaker with transvenous electrode(s); atrial and ventricular) for
pacemakers or CPT code 33249 (Insertion or replacement of permanent
pacing cardioverter-defibrillator system with transvenous lead(s),
single or dual chamber) for pacing cardioverter-defibrillators. The
commenters noted that hospitals would still be required to assign an
``FB'' or ``FC'' modifier to the procedure code representing the
replacement procedure, and the applicable offset would be applied to
the entire APC payment, even when only one of the devices involved in
the procedure was received at no cost or with full or partial credit.
According to the commenters, the offset reduction may actually be much
greater or much less than the credit received by the hospital,
depending upon the component that was credited. The commenters
requested that CMS alleviate this issue by allowing hospitals to bill
individual CPT codes for each component of the replacement procedure,
rather than requiring the reporting of a full system as suggested by
the CPT guidance. The commenters stated that this would allow the FB or
FC modifiers and the respective offsets to be applied accurately to the
payment for the individual component receiving the credit, rather than
being broadly applied to the APC payment for the entire replacement.
Response: We agree with the commenters that hospitals would be
required to assign an ``FB'' or ``FC'' modifier to the procedure code
representing the pacemaker or ICD replacement procedure as they
describe, and that the applicable offset would be applied to the entire
APC payment, even when just one of the devices involved in the
procedure (that is, a lead or a generator) was received at no cost or
with full or partial credit. However, we do not agree that this is
problematic. As the commenter noted, the offset reduction may actually
be much greater or much less than the credit received by the hospital,
depending upon the component that was credited. As we have stated in
the past (76 FR 74282), we recognize that, in some cases, the estimated
device cost and, therefore, the amount of the payment reduction will be
more or less than the cost a hospital would otherwise incur. However,
because averaging is inherent in a prospective payment system, we do
not believe this is inappropriate. Therefore, we do not agree that we
should allow hospitals to bill individual CPT codes for each component
of the replacement procedure, rather than requiring the reporting of a
full system as suggested by the CPT guidance, as the commenters
suggested.
Comment: One commenter noted that the no cost/full credit and
partial credit adjustment policy applies only when expensive devices
are replaced and requested clarification regarding the assignment of
the ``FB/FC'' modifier to devices that providers receive at no cost or
at an ``inexpensive'' cost. According to the commenter, providers lack
clear guidelines to determine what is meant by ``inexpensive.'' The
commenter also noted that there are inconsistencies between the ``FB/
FC'' modifier list and the list of device-dependent APCs in the CY 2013
OPPS/ASC proposed rule, specifically that the FB/FC listing is not an
inclusive listing of all device-dependent APCs.
Response: As we stated in the Medicare Claims Processing Manual
(Pub. 100-04, Chapter 4, Section 61.3.1), when a hospital furnishes a
device received without cost or with full credit from a manufacturer,
the hospital must append modifier ``-FB'' to the procedure code (not
the device code) that reports the service provided to furnish the
device. As we stated in the Medicare Claims Processing Manual (Pub.
100-04, Chapter 4, Section 61.3.3), when a hospital receives a partial
credit of 50 percent or more of the cost of a new replacement device
due to warranty, recall, or field action, the hospital must append
modifier ``-FC'' to the procedure code (not on the device code) that
reports the service provided to replace the device. This guidance does
not instruct providers to determine whether a no cost/full credit or
partial credit device is ``expensive'' or ``inexpensive.'' Rather,
providers should append the ``FB'' and ``FC'' modifiers to
[[Page 68358]]
all procedures that meet the requirements of these instructions. The I/
OCE determines, on a claim by claim basis, when to apply the no cost/
full credit and partial credit device adjustment policy (that is, when
both a specified device code is present on the claim, and the procedure
code to which the ``FB'' or ``FC'' modifier is appended maps to a
specified APC, as described previously in this section).
Regarding the comment that there are inconsistencies between the
``FB/FC'' modifier list and the list of device-dependent APCs in the CY
2013 OPPS/ASC proposed rule, we believe that the commenter is referring
to the fact that Table 20 in the CY 2013 OPPS/ASC proposed rule (the
list of proposed APCs to which the no cost/full credit and partial
credit device adjustment policy would apply (77 FR 45127)) and Table 4A
(the list of proposed device-dependent APCs (77 FR 45082)) are not
identical. The commenter is correct that the list of APCs to which the
no cost/full credit and partial credit device adjustment policy will
apply in CY 2013 in this section and the list of device-dependent APCs
in section II.A.2.d.(1) of the proposed rule and this final rule with
comment period are not the same. We believe this is appropriate
because, as we describe earlier in this section, we use the following
criteria to determine the list of APCs to which this policy will apply:
(1) All procedures assigned to the selected APCs must involve
implantable devices that would be reported if device insertion
procedures were performed; (2) the required devices must be surgically
inserted or implanted devices that remain in the patient's body after
the conclusion of the procedure (at least temporarily); and (3) the
device offset amount must be significant. Not all device-dependent APCs
meet these criteria, and therefore are appropriately excluded from the
list of APCs to which the no cost/full credit and partial credit device
adjustment policy applies.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposals, without modification, to continue the
established no cost/full credit and partial credit adjustment policies.
Table 29 below lists the APCs to which the payment adjustment policy
for no cost/full credit and partial credit devices will apply in CY
2013 and displays the final adjustment percentages for both no cost/
full credit and partial credit circumstances. Table 30 below lists the
devices to which the no cost/full credit and partial credit device
adjustment policy will apply for CY 2013, consistent with the three
selection criteria discussed earlier in this section and based on the
CY 2011 claims data available for this final rule with comment period.
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V. OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. OPPS Transitional Pass-Through Payment for Additional Costs of
Drugs, Biologicals, and Radiopharmaceuticals
1. Background
Section 1833(t)(6) of the Act provides for temporary additional
payments or ``transitional pass-through payments'' for certain drugs
and biologicals (also referred to as biologics). As enacted by the
Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act (BBRA) of
1999 (Pub. L. 106-113), this provision requires the Secretary to make
additional payments to hospitals for: current orphan drugs, as
designated under section 526 of the Federal Food, Drug, and Cosmetic
Act (Pub. L. 107-186); current drugs and biologicals and brachytherapy
sources used for the treatment of cancer; and current
radiopharmaceutical drugs and biologicals. For those drugs and
biologicals referred to as ``current,'' the transitional pass-through
payment began on the first date the hospital OPPS was implemented.
Transitional pass-through payments also are provided for certain
``new'' drugs and biologicals that were not being paid for as an HOPD
service as of December 31, 1996, and whose cost is ``not
insignificant'' in relation to the OPPS payments for the procedures or
services associated with the new drug or biological. For pass-through
payment purposes, radiopharmaceuticals are included as ``drugs.'' Under
the statute, transitional pass-through payments for a drug or
biological described in section 1833(t)(6)(C)(i)(II) of the Act can be
made for a period of at least 2 years, but not more than 3 years, after
the product's first payment as a hospital outpatient service under
Medicare Part B. Proposed CY 2013 pass-through drugs and biologicals
and their designated APCs were assigned status indicator ``G'' in
Addenda A and B to the proposed rule and in this final rule with
comment period, which are available via the Internet on the CMS Web
site.
Section 1833(t)(6)(D)(i) of the Act specifies that the pass-through
payment amount, in the case of a drug or biological, is the amount by
which the amount determined under section 1842(o) of the Act for the
drug or biological exceeds the portion of the otherwise applicable
Medicare OPD fee schedule that the Secretary determines is associated
with the drug or biological. If the drug or biological is covered under
a competitive acquisition contract under section 1847B of the Act, the
pass-through payment amount is determined by the Secretary to be equal
to the average price for the drug or biological for all competitive
acquisition areas and the year established under such section as
calculated and adjusted by the Secretary. However, we note that the
Part B drug CAP program has been postponed since CY 2009, and such a
program has not been reinstated for CY 2013.
This methodology for determining the pass-through payment amount is
set forth in regulations at 42 CFR 419.64. These regulations specify
that the pass-through payment equals the amount determined under
section 1842(o) of the Act minus the portion of the APC payment that
CMS determines is associated with the drug or biological. Section 1847A
of the Act establishes the average sales price (ASP) methodology, which
is used for payment for drugs and biologicals described in section
1842(o)(1)(C) of the Act furnished on or after January 1, 2005. The ASP
methodology, as applied under the OPPS, uses several sources of data as
a basis for payment, including the ASP, the wholesale acquisition cost
(WAC), and the average wholesale price (AWP). In this final rule with
comment period, the term ``ASP methodology'' and ``ASP-based'' are
inclusive of all data sources and methodologies described therein.
Additional information on the ASP methodology can be found on the CMS
Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
For CYs 2005, 2006, and 2007, we estimated the OPPS pass-through
payment amount for drugs and biologicals to be zero based on our
interpretation that the ``otherwise applicable Medicare OPD fee
schedule'' amount was equivalent to the amount to be paid for pass-
through drugs and biologicals under section 1842(o) of the Act (or
section 1847B of the Act if the drug or biological is covered under a
competitive acquisition contract). We concluded for those years that
the resulting difference between these two rates would be zero. For CYs
2008 and 2009, we estimated the OPPS pass-through payment amount for
drugs and biologicals to be $6.6 million and $23.3 million,
respectively. For CY 2010, we estimated the OPPS pass-through payment
estimate for drugs and biologicals to be $35.5 million. For CY 2011, we
estimated the OPPS pass-through payment for drugs and biologicals to be
$15.5 million. For CY 2012, we estimated the OPPS pass-through payment
for drugs and biologicals to be $19 million. Our OPPS pass-through
payment estimate for drugs and biologicals in CY 2013 is $22 million,
which is discussed in section VI.B. of this final rule with comment
period.
The pass-through application and review process for drugs and
biologicals is explained on the CMS Web site at: http://www.cms.gov/
Medicare/Medicare-Fee-for-Service-Payment/
[[Page 68363]]
HospitalOutpatientPPS/passthrough--payment.html.
2. Drugs and Biologicals With Expiring Pass-Through Status in CY 2012
In the CY 2013 OPPS/ASC proposed rule (77 FR 45128), we proposed
that the pass-through status of 23 drugs and biologicals would expire
on December 31, 2012, as listed in Table 22 of the proposed rule (77 FR
45129). All of these drugs and biologicals will have received OPPS
pass-through payment for at least 2 years and no more than 3 years by
December 31, 2012. These drugs and biologicals were approved for pass-
through status on or before January 1, 2011. With the exception of
those groups of drugs and biologicals that are always packaged when
they do not have pass-through status, specifically diagnostic
radiopharmaceuticals and contrast agents, our standard methodology for
providing payment for drugs and biologicals with expiring pass-through
status in an upcoming calendar year is to determine the product's
estimated per day cost and compare it with the OPPS drug packaging
threshold for that calendar year (which is $80), as discussed further
in section V.B.2. of this final rule with comment period. If the drug's
or biological's estimated per day cost is less than or equal to the
applicable OPPS drug packaging threshold, we would package payment for
the drug or biological into the payment for the associated procedure in
the upcoming calendar year. If the estimated per day cost of the drug
or biological is greater than the OPPS drug packaging threshold, we
would provide separate payment at the applicable relative ASP-based
payment amount (which is ASP+6 percent for CY 2013, as discussed
further in section V.B.3. of this final rule with comment period).
Section II.A.3.e. of this final rule with comment period discusses the
packaging of all nonpass-through contrast agents and diagnostic
radiopharmaceuticals.
Comment: Several commenters recommended that CMS continue pass-
through status for new drugs, specifically diagnostic
radiopharmaceuticals and contrast agents, for 3 years. The commenters
asserted that providing pass-through status for 3 years would help
provide a more current and accurate data set on which to base payment
amounts of the procedure when the diagnostic radiopharmaceutical or
contrast agent is subsequently packaged. The commenters further
recommended that CMS expire pass-through status for drugs and
biologicals on a quarterly as opposed to an annual basis. One commenter
disagreed with a prior CMS proposal to begin the pass-through payment
eligibility period on the date of first sale of the drug in the United
States following FDA approval. The commenter however approved of the
concurrent proposal made at that time that would require CMS to accept
and expire pass-through applications for drugs and biologicals on a
quarterly basis.
Response: As we stated in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74287), as described in section V.A. of this
final rule with comment period, section 1833(t)(6)(C)(i)(II) of the Act
permits CMS to make pass-through payments for a period of at least 2
but not more than 3 years, after the product's first payment as a
hospital outpatient service under Medicare Part B. We continue to
believe that this period of payment facilitates dissemination of these
new products into clinical practice and facilitates the collection of
sufficient hospital claims data reflective of their costs for future
OPPS ratesetting. Our longstanding practice has been to provide pass-
through payment for a period of 2 to 3 years, with expiration of pass-
through status proposed and finalized through the annual rulemaking
process. Each year, when proposing to expire the pass-through status of
certain drugs and biologicals, we examine our claims data for these
products. We observe that hospitals typically have incorporated these
products into their chargemasters based on the utilization and costs
observed in our claims data. Under the existing pass-through policy,
which has been generally supported by commenters, we begin pass-through
payment on a quarterly basis that depends on when applications are
submitted to us for consideration and because we expire pass-through
status only on an annual basis, there is no way to ensure that all
pass-through drugs and biologicals receive pass-through payment for a
full 3 years, while also providing pass-though payment for no more than
3 years as the statute requires. Further, we are confident that the
period of time for which drugs, biologicals, contrast agents, and
radiopharmaceuticals receive pass-through status, which is at least 2
but no more than 3 years, is adequate for CMS to collect the sufficient
amount of data to make a packaging determination.
We further note that we are in full compliance with the
requirements of the Act, which states that pass-through status is given
for at least 2 but no more than 3 years. As noted in section V.A.1. of
this final rule with comment period, when a product's pass-through
status expires, it is either packaged into an APC if it is a relatively
low-cost product that does not exceed the packaging threshold or is
``policy packaged'', or if it is a relatively high-cost product, it is
paid separately on the basis of the product's ASP (we refer readers to
section V.B.3. of this final rule with comment period for more details
regarding our payment policy for separately payable drugs). Because our
policies for drugs with expiring pass-through status recognize
products' relative costliness and establish either separate or bundled
payment as appropriate, based on such costliness, we disagree with
commenters that certain relatively high cost products currently
receiving pass-through payment would not be adequately paid if taken
off pass-through, and as a result should continue on such status. We
expire pass-though status on an annual basis. Depending on when a drug
is initially approved for pass-through status, the drug receives pass-
through payment for at least 2 but not more than 3 years.
Comment: Commenters, including several medical societies,
individual practitioners, and a manufacturer, requested that CMS
appropriately pay for HCPCS code C9275 (Injection, hexaminolevulinate
hydrochloride, 100 mg, per study dose). Some commenters believed that
payment would be eliminated for HCPCS code C9275 and requested that CMS
evaluate its statutory authority and establish appropriate payment as
necessary. One commenter recommended that CMS either continue to pay
separately for HCPCS code C9275 because, the commenter argued, an
insufficient amount of claims data have been collected, or assign HCPCS
code C9275 to a new technology APC with the accompanying blue light
cystoscopy procedure until sufficient claims are gathered to determine
assignment of an appropriate clinical APC category. The commenter
further argued that because C9275 will always be used with the blue
light cystoscopy procedure, packaging C9275 will result in zero payment
for the imaging agent, since current cystoscopy APCs do not include
costs of imaging agents.
The commenter stated that if CMS chooses to not provide payment for
HCPCS code C9275 as a separately billable product, CMS should use its
``waiver authority'' under section 1833(t)(2)(E) of the Act to ensure
that equitable payments are made under the OPPS for C9275. The
commenter noted that, for CY 2013, CMS used this statutory authority to
propose an
[[Page 68364]]
additional payment for radioisotopes derived from non-HEU sources.
Response: We proposed for CY 2013 to package the payment, for all
contrast agents, that are not on pass-through status, into the payment
for the associated service. We continue to believe that all nonpass-
through contrast agents function effectively as supplies that are
ancillary and supportive to an independent service. The product
described by HCPCS code C9275 is a contrast agent that was approved for
pass-through status beginning on January 1, 2011. For the CY 2013 OPPS/
ASC proposed rule (77 FR 45128 through 45129), we proposed to expire
pass-through status for this product because it had received at least 2
and no more than 3 years, as permitted by the Act in section
1833(t)(6). We note that because we expire pass-through status on an
annual basis and not a quarterly basis, we cannot extend the pass-
through status for HCPCS code C9275 for an additional number of years
because it would be counter to our current policy. Therefore, we
believe that our proposal to expire pass-through status for HCPCS code
C9275 for CY 2013 is appropriate.
We disagree with the commenter that a sufficient amount of data was
not collected for HCPCS code C9275 during its period under pass-through
status. As we stated previously, we believe this pass-through period of
payment facilitates dissemination for new products into clinical
practice and facilitates the collection of hospital claims data,
reflective of their costs for future OPPS ratesetting. Each year, when
proposing to expire the pass-through status of certain drugs and
biologicals, we examine our claims data for these products. We observe
that hospitals typically have incorporated these products, where the
product is being used, into their chargemasters based on the
utilization and costs observed in our claims data. We believe a
sufficient amount of claims data has been collected in this case and we
see no reason to exempt C9275 as an extraordinary case from our
longstanding packaging policy to package payment for nonpass-through
contrast agents.
We also do not believe that it is appropriate to extend separate
payment for HCPCS code C9275 based on section 1833(t)(2)(E) of the Act.
We believe that all hospitals have the opportunity to bill for and
receive equitable payment for HCPCS code C9275. Hospitals can bill for
an appropriate unlisted code for the cystoscopy procedure and include
the costs of the product currently reported by HCPCS code C9275 in that
specific claim, in order to receive payment for the procedure and the
product. Therefore, we do not believe that there is an inequity that
should be adjusted. Additionally, we do not believe that an additional
payment amount should be made for HCPCS code C9275, for the reasons
given in this final rule with comment period, to ensure equitable
payments are made to hospitals. Further, extending the pass-through
status for HCPCS code C9275 beyond 3 years would not be permitted under
the statutory requirements of section 1833(t)(6) of the Act.
We believe that commenters have erroneously stated that payment
will not be made under the OPPS or that an insufficient amount of
payment will be given to the product described by HCPCS code C9275. We
remind commenters that products that are packaged under the OPPS
receive payment that is packaged into the payment for the associated
procedure. Hospitals include HCPCS codes and charges for packaged
services on their claims, and the estimated costs associated with those
packaged services are then added to the costs of separately payable
procedures on the same claims in establishing payment rates for the
separately payable services. Payment for the packaged product is then
included in the payment for the independent service. For HCPCS code
C9275, hospitals may bill an unlisted code for the cystoscopy procedure
and include the costs for HCPCS code C9275 on that claim. These costs
will additionally be included in future ratesetting for these products.
We continue to believe that packaging payment for ancillary and
dependent services creates appropriate incentives for hospitals to
seriously consider whether a new service or a new technology offers a
benefit that is sufficient to justify the cost of the new service or
new technology. Therefore, we believe that HCPCS code C9275 is
appropriately packaged for CY 2013 and we are finalizing our proposal
to expire pass-through status for C9275 and assign this HCPCS code to a
status indicator of ``N'' for CY 2013.
We note that comments pertaining to a potential future new
technology APC assignment or new technology APC application for HCPCS
code C9275 and the accompanying blue light cystoscopy procedure are
outside the scope of this final rule with comment period.
Comment: One commenter requested that CMS review the claims used in
calculating the packaging status of HCPCS code J7183 (Injection, von
willebrand factor complex (human), wilate, 1 i.u. vwf:rco) and assign
HCPCS code J7183 to status indicator ``K'' as pass-through status has
expired, but the cost per day exceeds $80.
Response: We appreciate the commenter's diligence. HCPCS code J7183
was erroneously assigned to a status indicator of ``N'' for the CY 2013
OPPS/ASC proposed rule (77 FR 45129). The per day cost for HCPCS code
J7183 for this final rule with comment period exceeds the $80 packaging
threshold for CY 2013. Therefore, we are finalizing our proposal, with
modification, to expire the pass-through status for HCPCS code J7183
and assign it to a status indicator of ``K'' for CY 2013.
After consideration of the public comments we received, we are
finalizing our proposal, with modification as described above, to
expire the pass-through status of the 23 drugs and biologicals listed
in Table 31 below. We are assigning HCPCS code J7183 to status
indicator ``K'' for CY 2013. Table 31 lists the drugs and biologicals
for which pass-through status will expire on December 31, 2012, the
status indicators, and the assigned APCs for CY 2013.
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3. Drugs, Biologicals, and Radiopharmaceuticals With New or Continuing
Pass-Through Status in CY 2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45129), we proposed to
continue pass-through status in CY 2013 for 21 drugs and biologicals.
None of these drugs and biologicals will have received OPPS pass-
through payment for at least 2 years and no more than 3 years by
December 31, 2012. These drugs and biologicals, which were approved for
pass-through status between April 1, 2011 and July 1, 2012, were listed
in Table 23 of the proposed rule (77 FR 45130 through 45131). The APCs
and HCPCS codes for these drugs and biologicals approved for pass-
through status through April 1, 2012 were assigned status indicator
``G'' in Addenda A and B of the proposed rule. Addenda A and B for the
proposed rule were available via the Internet on the CMS Web site.
Section 1833(t)(6)(D)(i) of the Act sets the amount of pass-through
payment for pass-through drugs and biologicals (the pass-through
payment amount) as the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. Payment for drugs and biologicals with pass-through
status under the OPPS is currently made at the physician's office
payment rate of ASP+6 percent. We believe it is consistent with the
statute and we proposed to continue to provide payment for drugs and
biologicals with pass-through status at a rate of ASP+6 percent in CY
2013, the amount that drugs and biologicals receive under section
1842(o) of the Act.
Thus, for CY 2013, we proposed to pay for pass-through drugs and
biologicals at ASP+6 percent, equivalent to the rate these drugs and
biologicals would receive in the physician's office setting in CY 2013.
We proposed that a $0.00 pass-through payment amount would be paid for
most pass-through drugs and biologicals under the CY 2013 OPPS because
the difference between the amount authorized under section 1842(o) of
the Act, which is ASP+6 percent, and the portion of the otherwise
applicable OPD fee schedule that the Secretary determines is
appropriate, proposed at ASP+6 percent, is $0.
In the case of pass-through contrast agents and diagnostic
radiopharmaceuticals, their pass-through payment amount would be equal
to ASP+6 percent because, if not on pass-through status, payment for
these products would be packaged into the associated procedure.
Therefore, we proposed that the difference between ASP+6 percent and
the ``policy-packaged'' drug APC offset amount for the associated
clinical APC in which the drug or biological is utilized would be the
CY 2013 pass-through payment amount for these policy-packaged products.
In addition, we proposed to continue to update pass-through payment
rates on a quarterly basis on the CMS Web site during CY 2013 if later
quarter ASP submissions (or more recent WAC or AWP information, as
applicable) indicate that adjustments to the payment rates for these
pass-through drugs or biologicals are necessary. For a full description
of this policy, we refer readers to the CY 2006 OPPS/ASC final rule
with comment period (70 FR 42722 and 42723).
As is our standard methodology, we annually review new permanent
HCPCS codes and delete temporary HCPCS C-codes if an alternate
permanent HCPCS code is available for purposes of OPPS billing and
payment. We specifically reviewed drugs with pass-through status for CY
2013 that will change from C-codes to J-codes for CY 2013. For our CY
2013 review, we have determined that HCPCS code J1741 (Injection,
ibuprofen, 100 mg) describes the product reported under HCPCS code
C9279 (Injection, ibuprofen, 100 mg), HCPCS code J0485 (Injection,
belatacept, 1 mg) describes the product reported under HCPCS code C9286
(Injection, belatacept, 1 mg), HCPCS code J9042 (Injection, brentuximab
vedotin, 1 mg) describes the code reported under HCPCS code C9287
(Injection, brentuximab vedotin, 1 mg), HCPCS code J0716 (Injection,
centruroides immune f(ab)2, up to 120 milligrams) describes the code
reported under HCPCS code C9288 (Injection, centruroides (scorpion)
immune f(ab)2 (equine), 1 vial), and HCPCS code J9019 (Injection,
asparaginase (erwinaze), 1,000 iu) describes the code reported under
HCPCS code C9289 (Injection, asparaginase Erwinia chrysanthemi, 1,000
international units (I.U.)).
In CY 2013, as is consistent with our CY 2012 policy for diagnostic
and therapeutic radiopharmaceuticals, we proposed to provide payment
for both diagnostic and therapeutic radiopharmaceuticals that are
granted pass-through status based on the ASP methodology. As stated
above, for purposes of pass-through payment, we consider
radiopharmaceuticals to be drugs under the OPPS. Therefore, if a
diagnostic or therapeutic radiopharmaceutical receives pass-through
status during CY 2013, we proposed to follow the standard ASP
methodology to determine the pass-through payment rate that drugs
receive under section 1842(o) of the Act, which is ASP+6 percent. If
ASP data are not available for a radiopharmaceutical, we
[[Page 68367]]
proposed to provide pass-through payment at WAC+6 percent, the
equivalent payment provided to pass-through drugs and biologicals
without ASP information. If WAC information is also not available, we
proposed to provide payment for the pass-through radiopharmaceutical at
95 percent of its most recent AWP.
Comment: Several commenters supported CMS' proposal to provide
payment at ASP+6 percent for drugs, biologicals, contrast agents, and
radiopharmaceuticals that are granted pass-through status. A few
commenters approved of the proposal to use the ASP methodology that
would provide payment based on WAC if ASP information is not available,
and payment at 95 percent of AWP if WAC information is not available.
Another commenter requested that CMS provide an additional payment for
radiopharmaceuticals that are granted pass-through status. The
commenter gave an example amount of ASP+10 percent. Finally, one
commenter, in response to both the proposal to continue to pay for
drugs and biologicals on pass-through status and those not on pass-
through status at ASP+6 percent, suggested that CMS explore alternative
payment mechanisms that reward the pharmaceutical care provided by
specialty trained pharmacists who ensure safe and effective medication
use and provide for screening of drug interactions and
contraindications.
Response: As discussed above, the statutorily mandated pass-through
payment for pass-through drugs and biologicals for CY 2013 generally
equals the amount determined under section 1842(o) of the Act minus the
portion of the otherwise applicable APC payment that CMS determines is
associated with the drug or biological. Therefore, the pass-through
payment is determined by subtracting the otherwise applicable payment
amount under the OPPS (ASP+6 percent for CY 2013) from the amount
determined under section 1842(o) of the Act (ASP+6 percent).
Regarding the comments that CMS should provide an additional
payment for radiopharmaceuticals that are granted pass-through status,
we note that for CY 2013, consistent with our CY 2012 payment policy
for diagnostic and therapeutic radiopharmaceuticals, we proposed to
provide payment for both diagnostic and therapeutic
radiopharmaceuticals with pass-through status based on the ASP
methodology. As stated above, the ASP methodology, as applied under the
OPPS, uses several sources of data as a basis for payment, including
the ASP, WAC if ASP is unavailable, and 95 percent of the
radiopharmaceutical's most recent AWP if ASP and WAC are unavailable.
For purposes of pass-through payment, we consider radiopharmaceuticals
to be drugs under the OPPS. Therefore, if a diagnostic or therapeutic
radiopharmaceutical receives pass-through status during CY 2013, we
proposed to follow the standard ASP methodology to determine its pass-
through payment rate under the OPPS to account for the acquisition and
pharmacy overhead costs, including compounding costs. We continue to
believe that a single payment is appropriate for diagnostic
radiopharmaceuticals with pass-through status in CY 2013, and that the
payment rate of ASP+6 percent (or payment based on the ASP methodology)
is appropriate to provide payment for both the radiopharmaceutical's
acquisition cost and any associated nuclear medicine handling and
compounding costs. We refer readers to section V.B.3. of this final
rule with comment period for further discussion of payment for
therapeutic radiopharmaceuticals based on ASP information submitted by
manufacturers, and readers may also refer to the CMS Web site at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
Finally, we note that the comment that suggested that CMS explore
alternative payment mechanisms that reward the pharmaceutical care
provided by specialty trained pharmacists who ensure safe and effective
medication use and provide for screening of drug interactions and
contraindications is outside the scope of this final rule with comment
period.
Comment: One commenter stated that HCPCS code J1572 (Injection,
immune globulin (flebogamma/flebogamma dif), intravenous, non-
lyophilized (e.g. liquid), 500 mg) received an approval for a labeling
change for the extraction process on January 20, 2012, but that this
did not constitute the approval of a ``new drug.'' The commenter
requested that CMS reevaluate the status indicator for HCPCS code J1572
and assign it to a status indicator of ``K'' instead of ``G'' for CY
2013, because the original FDA approval date for the product of
December 15, 2003 does not meet the criteria for pass-through status.
Response: For the CY 2013 OPPS/ASC proposed rule (77 FR 45129
through 45131), we proposed to continue pass-through status for HCPCS
code J1572 for the remainder of CY 2013. HCPCS code J1572 replaced
HCPCS code Q4091 on January 1, 2008. The product described by HCPCS
code J1572 also received FDA approval on December 15, 2003. When we
reviewed the drug pass-through application for the product described by
HCPCS code J1572, we concluded that the product described by HCPCS code
J1572 had not previously received pass-through payment under the OPPS
and had a cost that was not insignificant in relation to the OPD fee
schedule amount. Therefore, we approved pass-through status for HCPCS
code J1572 beginning on July 1, 2011. We believe that we appropriately
assigned pass-through status to HCPCS code J1572 and we continue to
believe that pass-through status should continue through CY 2013.
We disagree with the commenter that HCPCS code J1572 does not meet
the criteria for pass-through status because the original FDA approval
date for this product was December 15, 2003. We note that section
1833(t)(6)(A)(iv)(I) of the Act allows for pass-through payment for a
device, drug, or biological as long as payment for such item was not
being made as an outpatient hospital service as of December 31, 1996.
Furthermore, we reiterate that the statute provides in section
1833(t)(6)(B)(iii) of the Act that pass-through status shall be in
effect for a period of at least 2 but no more than 3 years of pass-
through payment. Therefore, we believe continuing pass-through status
for HCPCS code J1572 is appropriate.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period requested clarification on the dosage
descriptor for HCPCS code J9179 (Injection, eribulin mesylate, 0.1 mg).
The commenter noted that the final rule display version referenced
inconsistent dosage size.
Response: As displayed in Table 32 below, the correct dosage
descriptor for HCPCS code J9179 is 0.1mg. HCPCS code J9179 will
continue on pass-through status, with a status indicator of ``G,'' for
CY 2013.
After consideration of the public comments we received, we are
finalizing our proposal to provide payment for drugs, biologicals,
diagnostic and therapeutic radiopharmaceuticals and contrast agents
that are granted pass-through status based on the ASP methodology. If a
diagnostic or therapeutic radiopharmaceutical receives pass-through
status during CY 2013, we will follow the standard ASP methodology to
determine the pass-through payment rate that drugs receive under
section 1842(o) of the Act, which is ASP+6 percent. If ASP data are not
available for a radiopharmaceutical, we will provide pass-through
payment at WAC+6
[[Page 68368]]
percent, the equivalent payment provided to pass-through drugs and
biologicals without ASP information. If WAC information is also not
available, we will provide payment for the pass-through
radiopharmaceutical at 95 percent of its most recent AWP.
As discussed in more detail in section II.A.3.d. of this final rule
with comment period, over the last 5 years, we implemented a policy
whereby payment for all nonpass-through diagnostic radiopharmaceuticals
and contrast agents is packaged into payment for the associated
procedure. We proposed to continue the packaging of these items,
regardless of their per day cost, in CY 2013. As stated earlier, pass-
through payment is the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. Because payment for a drug that is either a
diagnostic radiopharmaceutical or a contrast agent (identified as a
``policy-packaged'' drug, first described in the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68639)) would otherwise be packaged if
the product did not have pass-through status, we believe the otherwise
applicable OPPS payment amount would be equal to the ``policy-
packaged'' drug APC offset amount for the associated clinical APC in
which the drug or biological is utilized. The calculation of the
``policy-packaged'' drug APC offset amounts is described in more detail
in section IV.A.2. of this final rule with comment period. It follows
that the copayment for the nonpass-through payment portion (the
otherwise applicable fee schedule amount that we would also offset from
payment for the drug or biological if a payment offset applies) of the
total OPPS payment for those drugs and biologicals would, therefore, be
accounted for in the copayment for the associated clinical APC in which
the drug or biological is used.
According to section 1833(t)(8)(E) of the Act, the amount of
copayment associated with pass-through items is equal to the amount of
copayment that would be applicable if the pass-through adjustment was
not applied. Therefore, as we did in CY 2012, we proposed to continue
to set the associated copayment amount for pass-through diagnostic
radiopharmaceuticals and contrast agents that would otherwise be
packaged if the item did not have pass-through status to zero for CY
2013. Similarly, we proposed that the associated copayment amount for
pass-through anesthesia drugs that would otherwise be packaged if the
item did not have pass-through status would be zero for CY 2013. As
discussed in further detail in section II.3.c.(2) of this final rule
with comment period, we are clarifying that our general policy is to
package drugs used for anesthesia, and that those anesthesia drugs with
pass-through status will be packaged upon the expiration of pass-
through status.
The separate OPPS payment to a hospital for the pass-through
diagnostic radiopharmaceutical, contrast agent, or anesthesia drug is
not subject to a copayment according to the statute. Therefore, we
proposed to not publish a copayment amount for these items in Addenda A
and B to the proposed rule (which were available via the Internet on
the CMS Web site).
Comment: Commenters supported the CY 2013 proposal to continue to
set the associated copayment amounts for pass-through diagnostic
radiopharmaceuticals and contrast agents that would otherwise be
packaged if the product did not have pass-through status to zero. The
commenters noted that this policy is consistent with statutory
requirements and provides cost-saving benefits to beneficiaries.
Response: We appreciate the commenters' support of our proposal. As
discussed in the CY 2013 OPPS/ASC proposed rule (77 FR 45129 through
45130), we believe that for drugs and biologicals that are ``policy-
packaged,'' the copayment for the nonpass-through payment portion of
the total OPPS payment for this subset of drugs and biologicals is
accounted for in the copayment of the associated clinical APC in which
the drug or biological is used. According to section 1833(t)(8)(E) of
the Act, the amount of copayment associated with pass-through items is
equal to the amount of copayment that would be applicable if the pass-
through adjustment was not applied. Therefore, we believe that the
copayment amount should be zero for drugs and biologicals that are
``policy-packaged,'' including diagnostic radiopharmaceuticals and
contrast agents. We also believe that the copayment amount should be
zero for anesthesia drugs that would otherwise be packaged if the item
did not have pass-through status.
After consideration of the public comments received, we are
finalizing our proposal, without modification, to continue to set the
associated copayment amount for pass-through diagnostic
radiopharmaceuticals and contrast agents that would otherwise be
packaged if the item did not have pass-through status to zero for CY
2013. We are also finalizing our proposal to extend this policy to
anesthesia drugs that have pass-through status, and to set a copayment
amount of zero for these drugs for CY 2013.
The 26 drugs and biologicals that we are continuing on pass-through
status for CY 2013 or have been granted pass-through status as of
January 2013 are displayed in Table 32 below.
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4. Provisions for Reducing Transitional Pass-Through Payments for
Diagnostic Radiopharmaceuticals and Contrast Agents To Offset Costs
Packaged Into APC Groups
a. Background
Prior to CY 2008, diagnostic radiopharmaceuticals and contrast
agents were paid separately under the OPPS if their mean per day costs
were greater than the applicable year's drug packaging threshold. In CY
2008 (72 FR 66768), we began a policy of packaging payment for all
nonpass-through diagnostic radiopharmaceuticals and contrast agents as
ancillary and supportive items and services into their associated
nuclear medicine procedures. Therefore, beginning in CY 2008, nonpass-
through diagnostic radiopharmaceuticals and contrast agents were not
subject to the annual OPPS drug packaging threshold to determine their
packaged or separately payable payment status, and instead all nonpass-
through diagnostic radiopharmaceuticals and contrast agents were
packaged as a matter of policy. For CY 2013, in the CY 2013 OPPS/ASC
proposed rule (77 FR 45131), we proposed to continue to package payment
for all nonpass-through diagnostic radiopharmaceuticals and contrast
agents, as discussed in section II.A.3.e. of the proposed rule and this
final rule with comment period.
b. Payment Offset Policy for Diagnostic Radiopharmaceuticals
As previously noted, radiopharmaceuticals are considered to be
drugs for OPPS pass-through payment purposes. As described above,
section 1833(t)(6)(D)(i) of the Act specifies that the transitional
pass-through payment amount for pass-through drugs and biologicals is
the difference between the amount paid under section 1842(o) of the Act
and the otherwise applicable OPD fee schedule amount. There is
currently one radiopharmaceutical with pass-through status under the
OPPS, HCPCS code A9584 (Iodine I-123 ioflupane, diagnostic, per study
dose, up to 5 millicuries). This product, which is presently referred
to using HCPCS code A9584, was granted pass-through status using HCPCS
code C9406 beginning July 1, 2011, and we proposed that it continue
receiving pass-through status in CY 2013. We currently apply the
established radiopharmaceutical payment offset policy to pass-through
payment for this product. As described earlier in section V.A.3. of
this final rule with comment period, we proposed that new pass-through
diagnostic radiopharmaceuticals would be paid at ASP+6 percent, while
those without ASP information would be paid at WAC+6 percent or, if WAC
is not available, payment would be based on 95 percent of the product's
most recently published AWP.
Because a payment offset is necessary in order to provide an
appropriate transitional pass-through payment, we deduct from the pass-
through payment for diagnostic radiopharmaceuticals an amount
reflecting the portion of the APC payment associated with predecessor
radiopharmaceuticals in order to ensure no duplicate
radiopharmaceutical payment is made. In CY 2009, we established a
policy to estimate the portion of each APC payment rate that could
reasonably be attributed to the cost of predecessor diagnostic
radiopharmaceuticals when considering a new diagnostic
radiopharmaceutical for pass-through payment (73 FR 68638 through
68641). Specifically, we use the ``policy-packaged'' drug offset
fraction for APCs containing nuclear medicine procedures, calculated as
1 minus the following: the cost from single procedure claims in the APC
after removing the cost for ``policy-packaged'' drugs divided by the
cost from single procedure claims in the APC.
In the CY 2010 OPPS/ASC final rule with comment period (74 FR 60480
through 60484), we finalized a policy to redefine ``policy-packaged''
drugs as only nonpass-through diagnostic radiopharmaceuticals and
contrast agents, as a result of the policy discussed in sections V.A.4.
and V.B.2.d. of the CY 2010 OPPS/ASC final rule with comment period (74
FR 60471 through 60477 and 60495 through 60499, respectively) that
treats nonpass-through implantable biologicals that are surgically
inserted or implanted (through a surgical incision or a natural
orifice) and implantable biologicals that are surgically inserted or
implanted (through a surgical incision or a natural orifice) with newly
approved pass-through status beginning in CY 2010 or later as devices,
rather than drugs. To determine the actual APC offset amount for pass-
through diagnostic radiopharmaceuticals that takes into consideration
the otherwise applicable OPPS payment amount, we multiply the ``policy-
packaged'' drug offset fraction by the APC payment amount for the
nuclear medicine procedure with which the pass-through diagnostic
radiopharmaceutical is used and, accordingly, reduce the separate OPPS
payment for the pass-through diagnostic radiopharmaceutical by this
amount.
Beginning in CY 2011 and as discussed in the CY 2011 OPPS/ASC final
rule with comment period (75 FR 71934 through 71936), we finalized a
policy to require hospitals to append modifier ``FB'' to specified
nuclear medicine procedures when the diagnostic radiopharmaceutical is
received at no cost/full credit. These
[[Page 68371]]
instructions are contained within the I/OCE CMS specifications on the
CMS Web site at http://www.cms.gov/Medicare/Coding/OutpatientCodeEdit/index.html.
For CY 2013 and future years, we proposed to continue to require
hospitals to append modifier ``FB'' to specified nuclear medicine
procedures when the diagnostic radiopharmaceutical is received at no
cost/full credit. In addition, we proposed to continue to require that
when a hospital bills with an ``FB'' modifier with the nuclear medicine
scan, the payment amount for procedures in the APCs listed in Table 24
of the proposed rule (77 FR 45132) would be reduced by the full
``policy-packaged'' offset amount appropriate for diagnostic
radiopharmaceuticals. Finally, we also proposed to continue to require
hospitals to report a token charge of less than $1.01 in cases in which
the diagnostic radiopharmaceutical is furnished without cost or with
full credit.
We did not receive any public comments on this proposal. Therefore,
we are finalizing our policy, without modification, to continue
requiring hospitals to append modifier ``FB'' to specified nuclear
medicine procedures when the diagnostic radiopharmaceutical is received
at no cost/full credit in CY 2013 and future years. In addition, we
will continue to reduce the payment amount for procedures in the APCs
listed in Table 33 in this final rule with comment period by the full
``policy-packaged'' offset amount appropriate for diagnostic
radiopharmaceuticals. Finally, we also will continue to require
hospitals to report a token charge of less than $1.01 in cases in which
the diagnostic radiopharmaceutical is furnished without cost or with
full credit.
For CY 2012, we finalized a policy to apply the diagnostic
radiopharmaceutical offset policy to payment for pass-through
diagnostic radiopharmaceuticals, as described above. For CY 2013, we
proposed to continue to apply the diagnostic radiopharmaceutical offset
policy to payment for pass-through diagnostic radiopharmaceuticals.
Comment: Commenters recommended that CMS continue to apply
radiopharmaceutical edits for nuclear medicine procedures using
radiopharmaceuticals as long as diagnostic radiopharmaceuticals are
packaged. The commenters noted that the proposed rule was silent on
whether CMS will continue this policy for CY 2013 and they requested
that CMS confirm in the final rule that it will continue to apply the
radiopharmaceutical edits and use only claims with a
radiopharmaceutical code in determining nuclear medicine APC rates.
Response: Beginning in CY 2008, we implemented nuclear medicine
procedure-to-radiolabeled product claims processing edits in the I/OCE
that required a diagnostic radiopharmaceutical to be present on the
same claim as a nuclear medicine procedure for payment under the OPPS
to be made. These edits ensure that hospitals submit correctly coded
claims that report the HCPCS codes for the products and their charges
that are necessary for performance of nuclear medicine procedures.
Although we do not discuss our policy regarding nuclear medicine-to-
radiolabeled product claims processing edits in this final rule with
comment period, we will continue to annually update and implement this
list in accordance with our original finalized policy. We refer readers
to the CY 2010 OPPS/ASC final rule with comment period (74 FR 60384
through 60390) for a detailed discussion of the nuclear medicine
procedure-to-radiolabeled product edits and the evolution of our edit
policy. In addition, specific instructions for the nuclear medicine
procedure-to-radiolabeled product claims processing edits are contained
within the I/OCE CMS specifications on the CMS Web site at http://www.cms.gov/OutpatientCodeEdit/02OCEQtrReleaseSpecs.asp#TopOfPage.
Comment: A few commenters recommended that CMS publish preliminary
offset amounts for diagnostic radiopharmaceuticals and contrast agents
with the proposed rule to allow for meaningful assessment of and public
comment on the data.
Response: The exact data used to calculate all of the proposed and
final payment rates, including the associated offset amounts, for the
CY 2013 OPPS are available for purchase under a CMS data use agreement
through the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HhospitalOutpatientPPS/index.html. This Web site
includes information about purchasing the ``OPPS Limited Data Set'',
which now includes the additional variables previously available only
in the OPPS identifiable data set, including ICD-9-CMS diagnosis codes
and revenue code payment amounts. We do not post the offset amounts by
APC until publication of the final rule with comment period because we
assign services to APCs based on our estimate of their full resource
cost, including, but not limited to, packaged diagnostic
radiopharmaceuticals and contrast agents. The offset amount is the
portion of each APC payment rate that could reasonably be attributed to
the cost of predecessor diagnostic radiopharmaceuticals and contrast
agents when considering a new diagnostic radiopharmaceutical and
contrast agent for pass-through payment and has no bearing on APC
assignment.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to continue to apply the
diagnostic radiopharmaceutical offset policy to payment for pass-
through diagnostic radiopharmaceuticals, as described in the CY 2013
OPPS/ASC proposed rule (77 FR 45131).
Table 33 below displays the APCs to which nuclear medicine
procedures will be assigned in CY 2013 and for which we expect that an
APC offset could be applicable in the case of diagnostic
radiopharmaceuticals with pass-through status.
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c. Payment Offset Policy for Contrast Agents
Section 1833(t)(6)(D)(i) of the Act specifies that the transitional
pass-through payment amount for pass-through drugs and biologicals is
the difference between the amount paid under section 1842(o) of the Act
and the otherwise applicable OPD fee schedule amount. There currently
are no contrast agents with pass-through status under the OPPS. As
described in section V.A.3. of the proposed rule, we proposed that new
pass-through contrast agents would be paid at ASP+6 percent, while
those without ASP information would be paid at WAC+6 percent or, if WAC
is not available, payment would be based on 95 percent of the product's
most recently published AWP.
Although there are no contrast agents with pass-through status, we
believe that a payment offset is necessary in the event that a new
contrast agent is approved for pass-through status during CY 2013, in
order to provide an appropriate transitional pass-through payment for
them because all of these items are packaged when they do not have
pass-through status. In accordance with our standard offset
methodology, in the CY 2013 OPPS/ASC proposed rule (77 FR 45132), we
proposed for CY 2013 to deduct from the payment for new pass-through
contrast agents that are approved for pass-through status as a drug or
biological during CY 2013, an amount that reflects the portion of the
APC payment associated with predecessor contrast agents, in order to
ensure no duplicate contrast agent payment is made.
In CY 2010, we established a policy to estimate the portion of each
APC payment rate that could reasonably be attributed to the cost of
predecessor contrast agents when considering new contrast agents for
pass-through payment (74 FR 60482 through 60484). For CY 2013, as we
did in CY 2012, we proposed to continue to apply this same policy to
contrast agents. Specifically, we proposed to utilize the ``policy-
packaged'' drug offset fraction for clinical APCs calculated as 1 minus
(the cost from single procedure claims in the APC after removing the
cost for ``policy-packaged'' drugs divided by the cost from single
procedure claims in the APC). In CY 2010, we finalized a policy to
redefine ``policy-packaged'' drugs as only nonpass-through diagnostic
radiopharmaceuticals and contrast agents (74 FR 60495 through 60499).
To
[[Page 68373]]
determine the actual APC offset amount for pass-through contrast agents
that takes into consideration the otherwise applicable OPPS payment
amount, we proposed to multiply the ``policy-packaged'' drug offset
fraction by the APC payment amount for the procedure with which the
pass-through contrast agent is used and, accordingly, reduce the
separate OPPS payment for the pass-through contrast agent by this
amount. We proposed to continue to apply this methodology for CY 2013
to recognize that when a contrast agent with pass-through status is
billed with any procedural APC listed in Table 25 of the proposed rule
(77 FR 45132 through 45133), a specific offset based on the procedural
APC would be applied to payments for the contrast agent to ensure that
duplicate payment is not made for the contrast agent.
As we proposed, for this final rule with comment period, we will
continue to post annually on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html a file that contains the APC offset amounts that will be
used for that year for purposes of both evaluating cost significance
for candidate pass-through device categories and drugs and biologicals,
including contrast agents, and establishing any appropriate APC offset
amounts. Specifically, the file will continue to provide the amounts
and percentages of APC payment associated with packaged implantable
devices, ``policy-packaged'' drugs, and ``threshold-packaged'' drugs
and biologicals for every OPPS clinical APC.
We proposed to identify procedural APCs for which we expect a
contrast offset could be applicable in the case of a pass-through
contrast agent as any procedural APC with a ``policy-packaged'' drug
amount greater than $20 that is not a nuclear medicine APC identified
in Table 33 above, and these APCs are displayed in Table 34 below. The
methodology used to determine a threshold cost for application of a
contrast agent offset policy is described in detail in the CY 2010
OPPS/ASC final rule with comment period (70 FR 60483 through 60484).
For CY 2013, we proposed to continue to recognize that when a contrast
agent with pass-through status is billed with any procedural APC listed
in Table 25 of the proposed rule (77 FR 45132 through 45133), a
specific offset based on the procedural APC would be applied to payment
for the contrast agent to ensure that duplicate payment is not made for
the contrast agent.
Comment: One commenter urged CMS to publish the proposed offset
amount for contrast agents in the proposed rule to allow interested
stakeholders the opportunity to review the data and comment on the
amount of the offset.
Response: As we stated previously, the exact data used to calculate
all of the proposed and final payment rates, including the associated
offset amounts, for the CY 2013 OPPS are available for purchase under a
CMS data use agreement through the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. This Web site includes information about purchasing the
``OPPS Limited Data Set'', which now includes the additional variables
previously available only in the OPPS identifiable data set, including
ICD-9-CMS diagnosis codes and revenue code payment amounts. We do not
post the offset amounts by APC until publication of the final rule
because we assign services to APCs based on our estimate of their full
resource cost, including, but not limited to, packaged contrast agents.
The offset amount is the portion of each APC payment rate that could
reasonably be attributed to the cost of a predecessor contrast agent
when considering a new diagnostic radiopharmaceutical and contrast
agent for pass-through payment and has no bearing on APC assignment.
After consideration of the public comments we received, we are
finalizing our proposal for CY 2013 without modification.
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B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
Without Pass-Through Status
1. Background
Under the CY 2012 OPPS, we currently pay for drugs, biologicals,
and radiopharmaceuticals that do not have pass-through status in one of
two ways: As a packaged payment included in the payment for the
associated service, or as a separate payment (individual APCs). We
explained in the April 7, 2000 OPPS final rule with comment period (65
FR 18450) that we generally package the cost of drugs and
radiopharmaceuticals into the APC payment rate for the procedure or
treatment with which the products are usually furnished. Hospitals do
not receive separate payment for packaged items and supplies, and
hospitals may not bill beneficiaries separately for any
[[Page 68375]]
packaged items and supplies whose costs are recognized and paid within
the national OPPS payment rate for the associated procedure or service.
(Transmittal A-01-133, issued on November 20, 2001, explains in greater
detail the rules regarding separate payment for packaged services.)
Packaging costs into a single aggregate payment for a service,
procedure, or episode-of-care is a fundamental principle that
distinguishes a prospective payment system from a fee schedule. In
general, packaging the costs of items and services into the payment for
the primary procedure or service with which they are associated
encourages hospital efficiencies and also enables hospitals to manage
their resources with maximum flexibility.
2. Criteria for Packaging Payment for Drugs, Biologicals, and
Radiopharmaceuticals
a. Background
As indicated in section V.B.1. of this final rule with comment
period, in accordance with section 1833(t)(16)(B) of the Act, the
threshold for establishing separate APCs for payment of drugs and
biologicals was set to $50 per administration during CYs 2005 and 2006.
In CY 2007, we used the four quarter moving average Producer Price
Index (PPI) levels for Pharmaceutical Preparations (Prescription) to
trend the $50 threshold forward from the third quarter of CY 2005 (when
the Pub. L. 108-173 mandated threshold became effective) to the third
quarter of CY 2007. We then rounded the resulting dollar amount to the
nearest $5 increment in order to determine the CY 2007 threshold amount
of $55. Using the same methodology as that used in CY 2007 (which is
discussed in more detail in the CY 2007 OPPS/ASC final rule with
comment period (71 FR 68085 through 68086)), we set the packaging
threshold for establishing separate APCs for drugs and biologicals at
$60 for CYs 2008 and 2009. For CY 2010, we set the packaging threshold
at $65; for CY 2011, we set the packaging threshold at $70; and for CY
2012, we set the packaging threshold at $75.
Following the CY 2007 methodology, for the CY 2013 OPPS/ASC
proposed rule (77 FR 45133), we used the most recently available four
quarter moving average PPI levels to trend the $50 threshold forward
from the third quarter of CY 2005 to the third quarter of CY 2013 and
rounded the resulting dollar amount ($81.59) to the nearest $5
increment, which yielded a figure of $80. In performing this
calculation, we used the most recent forecast of the quarterly index
levels for the PPI for Pharmaceuticals for Human Use (Prescription)
(Bureau of Labor Statistics (BLS) series code WPUSI07003) from CMS'
Office of the Actuary (OACT). (We note that we did not propose a change
to the PPI that is used to calculate the threshold for CY 2013; rather,
this change in terminology reflects a change to the BLS naming
convention for this series.) We refer below to this series generally as
the PPI for Prescription Drugs.
We chose this PPI as it reflects price changes associated with the
average mix of all pharmaceuticals in the overall economy. In addition,
we chose this price series because it is publicly available and
regularly published, improving public access and transparency.
Forecasts of the PPI for Prescription Drugs are developed by IHS Global
Insight, Inc., a nationally recognized economic and financial
forecasting firm. As actual inflation for past quarters replaced
forecasted amounts, the PPI estimates for prior quarters have been
revised (compared with those used in the CY 2007 OPPS/ASC final rule
with comment period) and have been incorporated into our calculation.
Based on the calculations described above, we proposed a packaging
threshold for CY 2013 of $80. (For a more detailed discussion of the
OPPS drug packaging threshold and the use of the PPI for Prescription
Drugs, we refer readers to the CY 2007 OPPS/ASC final rule with comment
period (71 FR 68085 through 68086).)
b. Cost Threshold for Packaging of Payment for HCPCS Codes That
Describe Certain Drugs, Nonimplantable Biologicals, and Therapeutic
Radiopharmaceuticals (``Threshold-Packaged Drugs'')
In the CY 2013 OPPS/ASC proposed rule (77 FR 45134), to determine
the proposed CY 2013 packaging status for all nonpass-through drugs and
biologicals that are not policy packaged, we calculated on a HCPCS
code-specific basis the per day cost of all drugs, nonimplantable
biologicals, and therapeutic radiopharmaceuticals (collectively called
``threshold-packaged'' drugs) that had a HCPCS code in CY 2011 and were
paid (via packaged or separate payment) under the OPPS. We used data
from CY 2011 claims processed before January 1, 2012 for this
calculation. However, we did not perform this calculation for those
drugs and biologicals with multiple HCPCS codes that include different
dosages as described in section V.B.2.c. of this final rule with
comment period or for diagnostic radiopharmaceuticals, contrast agents,
and implantable biologicals that we proposed to continue to package in
CY 2013, as discussed in section V.B.2.d. of this final rule with
comment period.
In order to calculate the per day costs for drugs, nonimplantable
biologicals, and therapeutic radiopharmaceuticals to determine their
proposed packaging status in CY 2013, we used the methodology that was
described in detail in the CY 2006 OPPS proposed rule (70 FR 42723
through 42724) and finalized in the CY 2006 OPPS final rule with
comment period (70 FR 68636 through 70 FR 68638). For each drug and
nonimplantable biological HCPCS code, we used an estimated payment rate
of ASP+6 percent (which is the payment rate we proposed for separately
payable drugs and nonimplantable biologicals for CY 2013, as discussed
in more detail in section V.B.3.b. of this final rule with comment
period) to calculate the CY 2013 proposed rule per day costs. We used
the manufacturer submitted ASP data from the fourth quarter of CY 2011
(data that were used for payment purposes in the physician's office
setting, effective April 1, 2012) to determine the proposed rule per
day cost.
As is our standard methodology, for CY 2013 we proposed to use
payment rates based on the ASP data from the fourth quarter of CY 2011
for budget neutrality estimates, packaging determinations, impact
analyses, and completion of Addenda A and B to the proposed rule (which
was available via the Internet on the CMS Web site) because these were
the most recent data available for use at the time of development of
the proposed rule. These data were also the bases for drug payments in
the physician's office setting, effective April 1, 2012. For items that
did not have an ASP-based payment rate, such as some therapeutic
radiopharmaceuticals, we used their mean unit cost derived from the CY
2011 hospital claims data to determine their per day cost.
We proposed to package items with a per day cost less than or equal
to $80, and identify items with a per day cost greater than $80 as
separately payable. Consistent with our past practice, we crosswalked
historical OPPS claims data from the CY 2011 HCPCS codes that were
reported to the CY 2012 HCPCS codes that we displayed in Addendum B of
the proposed rule (which was available via the Internet on the CMS Web
site) for payment in CY 2013.
Comment: The majority of commenters objected to the proposed
increase in the OPPS packaging threshold to $80 for CY 2013. The
[[Page 68376]]
commenters recommended that CMS consider either eliminating the drug
packaging threshold and providing separate payment for all drugs with
HCPCS codes or freezing the packaging threshold at $75 for CY 2013.
Many commenters objected to the use of a packaging threshold under the
OPPS when one is not used for physician's office payment. These
commenters argued for parity across the payment systems and they
expressed concern that the packaging threshold may impede beneficiary
access to lower cost packaged drugs in the HOPD setting. A few
commenters suggested that CMS limit increases in the packaging
threshold amount to the hospital update factor for the year, reflective
of all statutory adjustments. One commenter believed that these dollar
figures are arbitrary and recommended that CMS tie the threshold for
separate payment to the annual market basket rather than randomly
assigning thresholds for separate payment for these products.
One commenter noted that increasing the packaging threshold could
have the unintended impact of undermining conversion to LEU sources of
diagnostic radiopharmaceuticals if CMS adopts a proposal to unbundle
diagnostic radiopharmaceuticals from the APC rate under the policy
packaging rule without also waiving the dollar threshold for
radiopharmaceuticals produced from LEU sources.
Response: As discussed in detail in the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66758 through 66767), the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68643), the CY 2010 OPPS/ASC
final rule with comment period (74 FR 60485 through 60487), the CY 2011
OPPS/ASC final rule with comment period (75 FR 71940 through 71943),
and the CY 2012 OPPS/ASC final rule with comment period (76 FR 74300
through 74301), we continue to believe that unpackaging payment for all
drugs, biologicals and radiopharmaceuticals is inconsistent with the
concept of a prospective payment system and that such a change could
create an additional reporting burden for hospitals. The OPPS and the
MPFS (which applies to physician's services) are fundamentally
different payment systems with essential differences in their payment
policies and structures. Specifically, the OPPS is a prospective
payment system based on the concept of payment for groups of services
that share clinical and resource characteristics. Payment is made under
the OPPS according to prospectively established payment rates that are
related to the relative costs of hospital resources for services. When
physician's services are furnished in an office setting, they are paid
under the MPFS, which is a fee schedule based on the relative value of
each component. Under the MPFS, separate payment is made for each
service provided in the physician's office; when individual drugs are
administered to beneficiaries in the physician's office, they are
generally paid under the ASP methodology. In contrast, the OPPS
includes various drugs within a prospective payment system, where
payment for certain drugs is packaged into the associated procedure
payment for the APC group. Given the fundamental differences in the way
payment is made in an HOPD and a physician's office setting for these
drugs, differences in payment are to be expected.
In general, we do not believe that our packaging methodology under
the OPPS results in limited beneficiary access to drugs because
packaging is a fundamental component of a prospective payment system
that accounts for the cost of certain items and services in larger
payment bundles, recognizing that some cases may be more costly and
others less costly, but that, on average, OPPS payment is appropriate
for the services provided. The growing utilization associated with
packaged drugs and biologicals in our claims data suggests Medicare
beneficiaries have sufficient access to these items.
We note that, in CYs 2005 and 2006, the statutorily mandated drug
packaging threshold was set at $50, and we continue to believe that it
is appropriate to continue a drug packaging threshold for the CY 2013
OPPS for the reasons set forth below. As stated in the CY 2007 OPPS/ASC
final rule with comment period (71 FR 68086), we believe that packaging
certain items is a fundamental component of a prospective payment
system, that packaging these items does not lead to beneficiary access
issues and does not create a problematic site of service differential,
that updating the packaging threshold of $50 for the CY 2005 OPPS is
consistent with industry and government practices, and that the PPI for
Prescription Drugs is an appropriate mechanism to gauge Part B drug
inflation. Therefore, because of our continued belief that packaging is
a fundamental component of a prospective payment system that continues
to provide important flexibility and efficiency in the delivery of high
quality hospital outpatient services, we are not adopting the
commenters' recommendations to pay separately for all drugs,
biologicals, and radiopharmaceuticals for CY 2013 or to eliminate or to
freeze the packaging threshold at $75.
We disagree with the commenters who suggested that CMS should limit
increases in the outpatient drug packaging threshold amount to the
hospital update factor for the year, reflective of all statutory
adjustments or the market basket update. As stated above, we continue
to believe that updating the $50 threshold is consistent with industry
and government practices and that the PPI for Prescription Drugs is an
appropriate mechanism to gauge Part B drug inflation. As we stated in
the CY 2007 OPPS/ASC final rule with comment period (71 FR 68085), we
believe that the PPI for Prescription Drugs reflects price changes at
the wholesale or manufacturer stage. Because OPPS payment rates for
drugs and biologicals are generally based on the ASP data that are
reported by their manufacturers, we believe that the PPI for
Prescription Drugs is an appropriate price index to use to update the
packaging threshold for CY 2007 and beyond.
In contrast, the market basket update contains numerous price
proxies, including, but not limited to, proxies for wages and salaries,
utilities, and nonlabor-related expenses, that are not related to price
increases for prescription drugs. Therefore, we believe that the market
basket as a whole is not an appropriate mechanism for determining the
outpatient drug packaging threshold amount. Within the calculation of
the market basket update, we use the PPI for Prescription Drugs
specifically to measure the price growth for prescription drugs, but
price changes for prescription drugs are only one component of price
changes for the numerous items and services hospitals purchase.
Additionally, we strongly disagree with the commenter who suggested
that our methodology for updating the packaging threshold is arbitrary
and recommended that CMS tie the threshold for separate payment to the
annual market basket rather than randomly assigning thresholds for
separate payment for these products. As we have stated above, the PPI
for Prescription Drugs reflects price changes at the wholesale or
manufacturer stage. Because OPPS payment rates for drugs and
biologicals are generally based on the ASP data that are reported by
their manufacturer, we believe that the PPI for Prescription Drugs is
an appropriate price index to use to update the packaging threshold for
CY 2007 and subsequent years. Therefore, we believe that our continued
methodology of updating the
[[Page 68377]]
CY 2005 $50 packaging threshold for inflation based on the PPI for
Prescription Drugs is not arbitrary in nature nor does it have the
effect of randomly assigning a payment threshold for drugs. Our
methodology continues to be an accurate way to apply an annual
inflation adjustment factor that is consistent with the practices of
many health care payment policy areas, and many other areas of
government policy, that acknowledge real costs by using an inflation
adjustment factor instead of a static dollar value.
Finally, we disagree with commenters that increasing the packaging
threshold could have the unintended impact of undermining conversion to
LEU sources. As we discuss in section II.A.3.e. of this final rule with
comment period, we are finalizing our proposals for CY 2013 to continue
to package payment for all nonpass-through diagnostic
radiopharmaceuticals. Therefore, diagnostic radiopharmaceuticals will
not be subject to the packaging threshold and will instead be packaged
regardless of their per day cost. Additionally, as we discuss in
section III.A.C.3., removing the diagnostic radiopharmaceutical so that
this cost is passed through directly to Medicare is not consistent with
the fundamental concept of packaging under the OPPS. Moreover, the
diagnostic radiopharmaceutical is never separately billed, being a
supply in the diagnostic procedure it supports, so the true cost cannot
be captured by single service claims. Most significantly from the
standpoint of payment for non-HEU sources, however, a separate payment
for the diagnostic radiopharmaceutical does not unbundle the cost of
the isotope from the much larger cost of the drug component, nor does
it differentiate between HEU and non-HEU sources, so it does not create
a differential payment to further the CMS goals of payment equity or
the Administration's goal of promoting non-HEU conversion.
Comment: Several commenters suggested that CMS reinstate its policy
of separate payment for 5-HT3 antiemetics, which are a class of drugs
often used as part of an anticancer treatment regiment to treat nausea.
One commenter believed that CMS packaged all 5-HT3 antiemetic drugs
(HCPCS codes J1260 (Injection, dolasetron mesylate, 10 mg), J1626
(Injection, granisetron hydrochloride, 100 mcg), J2405 (Injection,
ondansetron hydrochloride, per 1 mg), J2469 (Injection, palonosetron
hcl, 25 mcg), Q0166 (Granisetron hydrochloride, 1 mg, oral, FDA-
approved prescription anti-emetic, for use as a complete therapeutic
substitute for an iv anti-emetic at the time of chemotherapy treatment,
not to exceed a 24 hour dosage regimen), Q0180 (Dolasetron mesylate,
100 mg, oral, FDA-approved prescription antiemetic, for use as a
complete therapeutic substitute for an iv anti-emetic at the time of
chemotherapy treatment, not to exceed a 24 hour dosage regimen)). The
commenter opposed the packaging of these drugs.
Response: We continue to believe that use of these antiemetics is
an integral part of an anticancer treatment regimen and that OPPS
claims data demonstrate their increasingly common hospital outpatient
utilization. As we stated in the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60488), we no longer believe that a specific
exemption to our standard drug payment methodology is necessary to
ensure access to the most appropriate antiemetic products for Medicare
beneficiaries. We continue to believe that our analysis conducted in
the CY 2010 OPPS/ASC proposed rule on 5-HT3 antiemetics (74 FR 35320),
along with the historical stability in prescribing patterns for these
products and the availability of generic alternatives for several of
these products, allows us to continue our policy of not specifically
exempting these products from the OPPS drug packaging threshold.
Additionally, we clarify that we did not propose to assign a
packaged payment status indicator to all 5-HT3 antiemetic codes in the
CY 2013 OPPS/ASC proposed rule. HCPCS code J2469 (Injection,
palonosetron hcl, 25 mcg) had a per day cost above the proposed $80
packaging threshold and was assigned a separately payable status
indicator of ``K'' for the proposed rule. HCPCS code J2469 has a CY
2013 estimated per day cost, from the CY 2011 claims data, above the CY
2013 drug packaging threshold and therefore will receive separate
payment in CY 2013.
Comment: One commenter recommended that CMS not package any drugs
used in anticancer regimens.
Response: We disagree with the commenter for the reasons mentioned
above. We believe that packaging certain items, including items used in
anticancer regimens, is a fundamental component of a prospective
payment system, and is an essential feature that distinguishes a
prospective payment system from a fee schedule. We do not believe that
packaging drugs used in an anticancer regimen or in outpatient
treatment of other significant disease leads to beneficiary access
issues. This finding is confirmed by our analysis of hospital claims
data in which we have found that beneficiaries appear to have adequate
access to cancer treatments, as is signified by ongoing volume growth
in cancer-related APCs and stability in prescribing products for
anticancer drugs such as 5-HT3 antiemetics, for which CMS has continued
to observe volume growth, even after we ended our multiyear exemption
from the packaging threshold for these products. In summary, after
consideration of the public comments we received, we are not providing
any exceptions to the standard drug packaging methodology for any class
of drugs, including anticancer therapies, for CY 2013.
Since publication of the CY 2013 OPPS/ASC proposed rule, consistent
with our policy of updating the packaging threshold with more recently
available data for the final rule, we have again followed the CY 2007
methodology for CY 2013 and used updated four quarter moving average
PPI index levels provided by the CMS Office of the Actuary to trend the
$50 threshold forward from the third quarter of CY 2005 to the third
quarter of CY 2013. We then rounded the resulting updated dollar amount
($81.91) to the nearest $5 increment, which yielded a figure of $80.
Therefore, after consideration for the public comments we received, and
consistent with our methodology for establishing the packaging
threshold using the most recent PPI forecast data, we are adopting a CY
2013 packaging threshold of $80. Our policy during previous cycles of
the OPPS has been to use updated ASP and claims data to make final
determinations of the packaging status of HCPCS codes for drugs,
nonimplantable biologicals, and therapeutic radiopharmaceuticals for
the OPPS/ASC final rule with comment period. We note that it is also
our policy to make an annual packaging determination for a HCPCS code
only when we develop the OPPS/ASC final rule with comment period for
the update year. Only HCPCS codes that are identified as separately
payable in the final rule with comment period are subject to quarterly
updates. For our calculation of per day costs of HCPCS codes for drugs
and nonimplantable biologicals in this CY 2013 OPPS/ASC final rule with
comment period, we proposed to use ASP data from the first quarter of
CY 2012, which is the basis for calculating payment rates for drugs and
biologicals in the physician's office setting using the ASP
methodology, effective July 1, 2012, along with updated hospital claims
data from CY
[[Page 68378]]
2011. We note that we also proposed to use these data for budget
neutrality estimates and impact analyses for this CY 2013 OPPS/ASC
final rule with comment period.
Payment rates for HCPCS codes for separately payable drugs and
nonimplantable biologicals included in Addenda A and B to this final
rule with comment period are based on ASP data from the second quarter
of CY 2012. These data are the basis for calculating payment rates for
drugs and biologicals in the physician's office setting using the ASP
methodology, effective October 1, 2012. These physician's office
payment rates will then be updated in the January 2013 OPPS update,
based on the most recent ASP data to be used for physician's office and
OPPS payment as of January 1, 2013. For items that do not currently
have an ASP-based payment rate, we proposed to recalculate their mean
unit cost from all of the CY 2011 claims data and updated cost report
information available for this CY 2013 final rule with comment period
to determine their final per day cost.
Consequently, the packaging status of some HCPCS codes for drugs,
nonimplantable biologicals, and therapeutic radiopharmaceuticals in
this CY 2013 OPPS/ASC final rule with comment period may be different
from the same drug HCPCS code's packaging status determined based on
the data used for the proposed rule. Under such circumstances, we
proposed to continue to follow the established policies initially
adopted for the CY 2005 OPPS (69 FR 65780) in order to more equitably
pay for those drugs whose cost fluctuates relative to the proposed CY
2013 OPPS drug packaging threshold and the drug's payment status
(packaged or separately payable) in CY 2012. Specifically, for CY 2013,
consistent with our historical practice, we proposed to apply the
following policies to these HCPCS codes for drugs, nonimplantable
biologicals, and therapeutic radiopharmaceuticals whose relationship to
the proposed $80 drug packaging threshold changes based on the updated
drug packaging threshold and on the final updated data:
HCPCS codes for drugs and nonimplantable biologicals that
were paid separately in CY 2012 and that were proposed for separate
payment in CY 2013, and that then have per day costs equal to or less
than $80, based on the updated ASPs and hospital claims data used for
this CY 2013 final rule with comment period, would continue to receive
separate payment in CY 2013.
HCPCS codes for drugs and nonimplantable biologicals that
were packaged in CY 2012 and that are proposed for separate payment in
CY 2013, and that then have per day costs equal to or less than $80,
based on the updated ASPs and hospital claims data used for this CY
2013 final rule with comment period, would remain packaged in CY 2013.
HCPCS codes for drugs and nonimplantable biologicals for
which we proposed packaged payment in CY 2013 but then have per day
costs greater than $80, based on the updated ASPs and hospital claims
data used for this CY 2013 final rule with comment period, would
receive separate payment in CY 2013.
We did not receive any public comments on our proposal to apply the
established policies initially adopted for the CY 2005 OPPS (69 FR
65780) in order to more equitably pay for those drugs whose cost
fluctuates relative to the CY 2013 OPPS drug packaging threshold and
the drug's payment status (packaged or separately payable) in CY 2012.
Therefore, we are finalizing our proposal, without modification, for CY
2013.
We note that HCPCS codes J2700 (Injection, oxacillin sodium, up to
250 mg) and J9218 (Leuprolide acetate, per 1 mg) were paid separately
for CY 2012 and were proposed for separate payment in the CY 2013 OPPS/
ASC proposed rule and had final per day costs of less than the $80 drug
packaging threshold, based on updated ASPs and the CY 2011 hospital
claims data available for this CY 2013 final rule with comment period.
Therefore, HCPCS codes J2700 and J9218 will continue to be paid
separately in CY 2013 according to the established methodology set
forth above.
In addition, we proposed to package HCPCS codes J0365 (Injection,
aprotonin, 10,000 kiu), J1460 (Injection, gamma globulin,
intramuscular, 1 cc), J1560 (Injection, gamma globulin, intramuscular,
over 10 cc), J7183 (Injection, von willebrand factor complex (human),
wilate, 1 i.u. vwf:rco), and Q4105 (Integra dermal regeneration
template (drt), per square centimeter) for CY 2013. Using updated ASPs
and the CY 2011 hospital claims data available for this final rule with
comment period, HCPCS codes J0365, J1460, J1560, J7183, and Q4105 now
have per day costs greater than $80. In accordance with our established
policy for such cases, for CY 2013 we will pay for HCPCS codes J0365,
J1460, J1560, J7183, and Q4105 separately.
Finally, because we did not have claims data for HCPCS codes J1452
(Injection, fomivirsen sodium, intraocular, 1.65 mg) and J1835
(Injection, itraconazole, 50 mg) in the CY 2013 OPPS/ASC proposed rule,
we had proposed a status indicator of ``E'' for these products in CY
2013. However, since publication of the proposed rule, we have received
claims data and the per day cost for these products are more than the
$80 CY 2013 packaged threshold. These products will be paid separately
and will be assigned a status indicator of ``K'' for CY 2013.
c. Packaging Determination for HCPCS Codes That Describe the Same Drug
or Biological but Different Dosages
In the CY 2008 OPPS/ASC final rule with comment period (72 FR
66776), we began recognizing, for OPPS payment purposes, multiple HCPCS
codes reporting different dosages for the same covered Part B drugs or
biologicals in order to reduce hospitals' administrative burden by
permitting them to report all HCPCS codes for drugs and biologicals. In
general, prior to CY 2008, the OPPS recognized for payment only the
HCPCS code that described the lowest dosage of a drug or biological. We
extended this recognition to multiple HCPCS codes for several other
drugs under the CY 2009 OPPS (73 FR 68665). During CYs 2008 and 2009,
we applied a policy that assigned the status indicator of the
previously recognized HCPCS code to the associated newly recognized
code(s), reflecting the packaged or separately payable status of the
new code(s). In the CY 2008 OPPS/ASC final rule with comment period (72
FR 66775), we explained that once claims data were available for these
previously unrecognized HCPCS codes, we would determine the packaging
status and resulting status indicator for each HCPCS code according to
the general, established HCPCS code-specific methodology for
determining a code's packaging status for a given update year. However,
we also stated that we planned to closely follow our claims data to
ensure that our annual packaging determinations for the different HCPCS
codes describing the same drug or biological did not create
inappropriate payment incentives for hospitals to report certain HCPCS
codes instead of others.
In the CY 2010 OPPS/ASC final rule with comment period (74 FR 60490
through 60491), we finalized a policy to make a single packaging
determination for a drug, rather than an individual HCPCS code, when a
drug has multiple HCPCS codes describing different dosages. We analyzed
CY 2008 claims data for the HCPCS codes describing different dosages of
the same drug or biological that were newly recognized in CY 2008 and
found that our claims data would result in several different
[[Page 68379]]
packaging determinations for different codes describing the same drug
or biological. Furthermore, we found that our claims data included few
units and days for a number of newly recognized HCPCS codes, resulting
in our concern that these data reflected claims from only a small
number of hospitals, even though the drug or biological itself may be
reported by many other hospitals under the most common HCPCS code.
Based on these findings from our first available claims data for the
newly recognized HCPCS codes, we believed that adopting our standard
HCPCS code-specific packaging determinations for these codes could lead
to payment incentives for hospitals to report certain HCPCS codes
instead of others, particularly because we do not currently require
hospitals to report all drug and biological HCPCS codes under the OPPS
in consideration of our previous policy that generally recognized only
the lowest dosage HCPCS code for a drug or biological for OPPS payment.
For CY 2013, we continue to believe that adopting the standard
HCPCS code-specific packaging determinations for these codes could lead
to payment incentives for hospitals to report certain HCPCS codes for
drugs instead of others. Making packaging determinations on a drug-
specific basis eliminates these incentives and allows hospitals
flexibility in choosing to report all HCPCS codes for different dosages
of the same drug or only the lowest dosage HCPCS code. Therefore, in
the CY 2013 OPPS/ASC proposed rule (77 FR 45135), we proposed to
continue our policy to make packaging determinations on a drug-specific
basis, rather than a HCPCS code-specific basis, for those HCPCS codes
that describe the same drug or biological but different dosages in CY
2013.
For CY 2013, in order to propose a packaging determination that is
consistent across all HCPCS codes that describe different dosages of
the same drug or biological, we aggregated both our CY 2011 claims data
and our pricing information at ASP+6 percent across all of the HCPCS
codes that describe each distinct drug or biological in order to
determine the mean units per day of the drug or biological in terms of
the HCPCS code with the lowest dosage descriptor. The following drugs
did not have pricing information available for the ASP methodology for
this CY 2013 OPPS/ASC final rule and, as is our current policy for
determining the packaging status of other drugs, we used the mean unit
cost available from the fourth quarter CY 2011 claims data to make the
packaging determinations for these drugs: HCPCS codes J3472 (Injection,
hyaluronidase, ovine, preservative free, per 1000 usp units), Q0171
(Chlorpromazine hydrochloride, 10 mg, oral, FDA approved prescription
antiemetic, for use as a complete therapeutic substitute for an IV
antiemetic at the time of chemotherapy treatment, not to exceed a 48-
hour dosage regimen), Q0172 (Chlorpromazine hydrochloride, 25 mg, oral,
FDA approved prescription anti-emetic, for use as a complete
therapeutic substitute for an IV anti-emetic at the time of
chemotherapy treatment, not to exceed a 48-hour dosage regimen), Q0175
(Perphenazine, 4 mg, oral, FDA approved prescription anti-emetic, for
use as a complete therapeutic substitute for an IV anti-emetic at the
time of chemotherapy treatment, not to exceed a 48-hour dosage
regimen), Q0176 (Perphenazine, 8 mg, oral, FDA approved prescription
anti-emetic, for use as a complete therapeutic substitute for an IV
anti-emetic at the time of chemotherapy treatment, not to exceed a 48-
hour dosage regimen), Q0177 (Hydroxyzine pamoate, 25 mg, oral, FDA
approved prescription anti-emetic, for use as a complete therapeutic
substitute for an IV anti-emetic at the time of chemotherapy treatment,
not to exceed a 48-hour dosage regimen), and Q0178 (Hydroxyzine
pamoate, 50 mg, oral, FDA approved prescription anti-emetic, for use as
a complete therapeutic substitute for an IV anti-emetic at the time of
chemotherapy treatment, not to exceed a 48-hour dosage regimen).
For all other drugs and biologicals that have HCPCS codes
describing different dosages, we then multiplied the weighted average
ASP+6 percent per unit payment amount across all dosage levels of a
specific drug or biological by the estimated units per day for all
HCPCS codes that describe each drug or biological from our claims data
to determine the estimated per day cost of each drug or biological at
less than or equal to $80 (whereupon all HCPCS codes for the same drug
or biological would be packaged) or greater than $80 (whereupon all
HCPCS codes for the same drug or biological would be separately
payable).
We did not receive any public comments on this proposal. Therefore,
we are finalizing our CY 2013 proposal, without modification. The
packaging status of each drug and biological HCPCS code to which this
methodology would apply is displayed in Table 35 below.
BILLING CODE 4120-01-P
[[Page 68380]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.051
[[Page 68381]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.052
[[Page 68382]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.053
BILLING CODE 4120-01-C
3. Payment for Drugs and Biologicals Without Pass-Through Status That
Are Not Packaged
a. Payment for Specified Covered Outpatient Drugs (SCODs) and Other
Separately Payable and Packaged Drugs and Biologicals
Section 1833(t)(14) of the Act defines certain separately payable
radiopharmaceuticals, drugs, and biologicals and mandates specific
payments for these items. Under section 1833(t)(14)(B)(i) of the Act, a
``specified covered outpatient drug'' is a covered outpatient drug, as
defined in section 1927(k)(2) of the Act, for which a separate APC has
been established and that either is a radiopharmaceutical agent or is a
drug or biological for which payment was made on a pass-through basis
on or before December 31, 2002.
Under section 1833(t)(14)(B)(ii) of the Act, certain drugs and
biologicals are designated as exceptions and are not included in the
definition of ``specified covered outpatient drugs,'' known as SCODs.
These exceptions are--
A drug or biological for which payment is first made on or
after January 1, 2003, under the transitional pass-through payment
provision in section 1833(t)(6) of the Act.
A drug or biological for which a temporary HCPCS code has
not been assigned.
During CYs 2004 and 2005, an orphan drug (as designated by
the Secretary).
Section 1833(t)(14)(A)(iii) of the Act requires that payment for
SCODs in CY 2006 and subsequent years be equal to the average
acquisition cost for the drug for that year as determined by the
Secretary, subject to any adjustment for overhead costs and taking into
account the hospital acquisition cost survey data collected by the
Government Accountability Office (GAO) in CYs 2004 and 2005, and later
periodic surveys conducted by the Secretary as set forth in the
statute. If hospital acquisition cost data are not available, the law
requires that payment be equal to payment rates established under the
methodology described in section 1842(o), section 1847A, or section
1847B of the Act, as calculated and adjusted by the Secretary as
necessary. Most physician Part B drugs are paid at ASP+6 percent
pursuant to section 1842(o) and section 1847A of the Act.
[[Page 68383]]
Section 1833(t)(14)(E) of the Act provides for an adjustment in
OPPS payment rates for overhead and related expenses, such as pharmacy
services and handling costs. Section 1833(t)(14)(E)(i) of the Act
required MedPAC to study pharmacy overhead and related expenses and to
make recommendations to the Secretary regarding whether, and if so how,
a payment adjustment should be made to compensate hospitals for
overhead and related expenses. Section 1833(t)(14)(E)(ii) of the Act
authorizes the Secretary to adjust the weights for ambulatory procedure
classifications for SCODs to take into account the findings of the
MedPAC study.
It has been our longstanding policy to apply the same treatment to
all separately payable drugs and biologicals, which include SCODs, and
drugs and biologicals that are not SCODs. Therefore, we apply the
payment methodology in section 1833(t)(14)(A)(iii)(I) of the Act to
SCODs, as required by statute, but we also apply it to separately
payable drugs and biologicals that are not SCODs, which is a policy
choice rather than a statutory requirement. In the CY 2013 OPPS/ASC
proposed rule, we proposed to apply section 1833(t)(14)(A)(iii)(II) of
the Act to all separately payable drugs and biologicals. Although we
did not distinguish SCODs in that discussion, we note that we are
required to apply section 1833(t)(14)(A)(iii)(II) of the Act to SCODs,
but we are choosing to apply it to other separately payable drugs and
biologicals, consistent with our history of using the same payment
methodology for all separately payable drugs and biologicals.
In the CY 2006 OPPS proposed rule (70 FR 42728 through 42731), we
discussed the June 2005 report by MedPAC regarding pharmacy overhead
costs in HOPDs and summarized the findings of that study. In response
to the MedPAC findings, in the CY 2006 OPPS proposed rule (70 FR
42729), we discussed our belief that, because of the varied handling
resources required to prepare different forms of drugs, it would be
impossible to exclusively and appropriately assign a drug to a certain
overhead category that would apply to all hospital outpatient uses of
the drug. Therefore, our CY 2006 OPPS proposal included a proposal to
establish three distinct Level II HCPCS C-codes and three corresponding
APCs for drug handling categories to differentiate overhead costs for
drugs and biologicals (70 FR 42730). We also proposed: (1) To combine
several overhead categories recommended by MedPAC; (2) to establish
three drug handling categories, as we believed that larger groups would
minimize the number of drugs that may fit into more than one category
and would lessen any undesirable payment policy incentives to utilize
particular forms of drugs or specific preparation methods; (3) to
collect hospital charges for these HCPCS C-codes for 2 years; and (4)
to ultimately base payment for the corresponding drug handling APCs on
CY 2006 claims data available for the CY 2008 OPPS.
In the CY 2006 OPPS final rule with comment period (70 FR 68659
through 68665), we discussed the public comments we received on our
proposal regarding pharmacy overhead. The overwhelming majority of
commenters did not support our proposal regarding pharmacy overhead and
urged us not to finalize this policy, as it would be administratively
burdensome for hospitals to establish charges for HCPCS codes for
pharmacy overhead and to report them. Therefore, we did not finalize
this proposal for CY 2006. Instead, we established payment for
separately payable drugs and biologicals at ASP+6 percent, which we
calculated by comparing the estimated aggregate cost of separately
payable drugs and biologicals in our claims data to the estimated
aggregate ASP dollars for separately payable drugs and biologicals,
using the ASP as a proxy for average acquisition cost (70 FR 68642).
Hereinafter, we refer to this methodology as our standard drug payment
methodology. We concluded that payment for drugs and biologicals and
pharmacy overhead at a combined ASP+6 percent rate would serve as an
acceptable proxy for the combined acquisition and overhead costs of
each of these products.
In the CY 2007 OPPS/ASC final rule with comment period (71 FR
68091), we finalized our proposed policy to provide a single payment of
ASP+6 percent for the hospital's acquisition cost for the drug or
biological and all associated pharmacy overhead and handling costs. The
ASP+6 percent rate that we finalized was higher than the equivalent
average ASP-based amount calculated from claims of ASP+4 percent
according to our standard drug payment methodology, but we adopted
payment at ASP+6 percent for stability while we continued to examine
the issue of the costs of pharmacy overhead in the HOPD and awaited the
accumulation of CY 2006 data as discussed in the prior year's rule.
In the CY 2008 OPPS/ASC proposed rule (72 FR 42735), in response to
ongoing discussions with interested parties, we proposed to continue
our methodology of providing a combined payment rate for drug and
biological acquisition and pharmacy overhead costs while continuing our
efforts to improve the available data. We also proposed to instruct
hospitals to remove the pharmacy overhead charge for both packaged and
separately payable drugs and biologicals from the charge for the drug
or biological and report the pharmacy overhead charge on an uncoded
revenue code line on the claim. We believed that this would provide us
with an avenue for collecting pharmacy handling cost data specific to
drugs in order to package the overhead costs of these items into the
associated procedures, most likely drug administration services.
Similar to the public response to our CY 2006 pharmacy overhead
proposal, the overwhelming majority of commenters did not support our
CY 2008 proposal and urged us to not finalize this policy (72 FR
66761). At its September 2007 meeting, the APC Panel recommended that
hospitals not be required to separately report charges for pharmacy
overhead and handling and that payment for overhead be included as part
of drug payment. The APC Panel also recommended that CMS continue to
evaluate alternative methods to standardize the capture of pharmacy
overhead costs in a manner that is simple to implement at the
organizational level (72 FR 66761). Because of concerns expressed by
the APC Panel and public commenters, we did not finalize the proposal
to instruct hospitals to separately report pharmacy overhead charges
for CY 2008. Instead, in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66763), we finalized a policy of providing payment for
separately payable drugs and biologicals and their pharmacy overhead at
ASP+5 percent as a transition from their CY 2007 payment of ASP+6
percent to payment based on the equivalent average ASP-based payment
rate calculated from hospital claims according to our standard drug
payment methodology, which was ASP+3 percent for the CY 2008 OPPS/ASC
final rule with comment period. Hospitals continued to include charges
for pharmacy overhead costs in the line-item charges for the associated
drugs reported on claims.
For CY 2009, we proposed to pay separately payable drugs and
biologicals at ASP+4 percent, including both SCODs and other drugs
without CY 2009 OPPS pass-through status, based on our standard drug
payment methodology. We also continued to explore mechanisms to improve
the available data. We proposed to split the
[[Page 68384]]
``Drugs Charged to Patients'' cost center into two cost centers: One
for drugs with high pharmacy overhead costs and one for drugs with low
pharmacy overhead costs (73 FR 41492). We noted that we expected that
CCRs from the proposed new cost centers would be available in 2 to 3
years to refine OPPS drug cost estimates by accounting for differential
hospital markup practices for drugs with high and low overhead costs.
After consideration of the public comments received and the APC Panel
recommendations, we finalized a CY 2009 policy (73 FR 68659) to provide
payment for separately payable nonpass-through drugs and biologicals
based on costs calculated from hospital claims at a 1-year transitional
rate of ASP+4 percent, in the context of an equivalent average ASP-
based payment rate of ASP+2 percent calculated according to our
standard drug payment methodology from the final rule claims data and
cost report data. We did not finalize our proposal to split the single
standard ``Drugs Charged to Patients'' cost center into two cost
centers largely due to concerns raised by hospitals about the
associated administrative burden. Instead, we indicated in the CY 2009
OPPS/ASC final rule with comment period (73 FR 68659) that we would
continue to explore other potential approaches to improve our drug cost
estimation methodology, thereby increasing payment accuracy for
separately payable drugs and biologicals.
In response to the CMS proposals for the CY 2008 and CY 2009 OPPS,
a group of pharmacy stakeholders (hereinafter referred to as the
pharmacy stakeholders), including some cancer hospitals, some
pharmaceutical manufacturers, and some hospital and professional
associations, commented that CMS should pay an acquisition cost of
ASP+6 percent for separately payable drugs, should substitute ASP+6
percent for the packaged cost of all packaged drugs and biologicals on
procedure claims, and should redistribute the difference between the
aggregate estimated packaged drug cost in claims and payment for all
drugs, including packaged drugs at ASP+6 percent, as separate pharmacy
overhead payments for separately payable drugs. They indicated that
this approach would preserve the aggregate drug cost observed in the
claims data, while significantly increasing payment accuracy for
individual drugs and procedures by redistributing drug cost from
packaged drugs. Their suggested approach would provide a separate
overhead payment for each separately payable drug or biological at one
of three different levels, depending on the pharmacy stakeholders'
assessment of the complexity of pharmacy handling associated with each
specific drug or biological (73 FR 68651 through 68652). Each
separately payable drug or biological HCPCS code would be assigned to
one of the three overhead categories, and the separate pharmacy
overhead payment applicable to the category would be made when each of
the separately payable drugs or biologicals was paid.
In the CY 2010 OPPS/ASC proposed rule (74 FR 35332), we
acknowledged the limitations of our data and our availability to find a
method to improve that data in a way that did not impose unacceptable
administrative burdens on providers. Accepting that charge compression
was a reasonable but unverifiable supposition, we proposed to
redistribute between one-third and one-half of the estimated overhead
cost associated with coded packaged drugs and biologicals with an ASP,
which resulted in our proposal to pay for the acquisition and pharmacy
overhead costs of separately payable drugs and biologicals that did not
have pass-through payment status at ASP+4 percent. We calculated
estimated overhead cost for coded packaged drugs and biologicals by
determining the difference between the aggregate claims cost for coded
packaged drugs and biologicals with an ASP and the ASP dollars (ASP
multiplied by the drug's or biological's units in the claims data) for
those same coded drugs and biologicals; this difference was our
estimated overhead cost for coded packaged drugs and biologicals. In
our rationale described in the CY 2010 OPPS/ASC proposed rule (74 FR
35326 through 35333), we stated that we believed that approximately
$150 million of the estimated $395 million total in pharmacy overhead
cost, specifically between one-third and one-half of that cost,
included in our claims data for coded packaged drugs and biologicals
with reported ASP data should be attributed to separately payable drugs
and biologicals and that the $150 million serves as the adjustment for
the pharmacy overhead costs of separately payable drugs and
biologicals. As a result, we also proposed to reduce the costs of coded
drugs and biologicals that are packaged into payment for procedural
APCs to offset the $150 million adjustment to payment for separately
payable drugs and biologicals. In addition, we proposed that any
redistribution of pharmacy overhead cost that may arise from the CY
2010 final rule data would occur only from some drugs and biologicals
to other drugs and biologicals, thereby maintaining the estimated total
cost of drugs and biologicals that we calculate based on the charges
and costs reported by hospitals on claims and cost reports. As a result
of this approach, no redistribution of cost would occur from other
services to drugs and biologicals or vice versa.
While we had no way of assessing whether this current distribution
of overhead cost to coded packaged drugs and biologicals with an ASP
was appropriate, we acknowledged that the established method of
converting billed charges to costs had the potential to ``compress''
the calculated costs to some degree. Further, we recognized that the
attribution of pharmacy overhead costs to packaged or separately
payable drugs and biologicals through our standard drug payment
methodology of a combined payment for acquisition and pharmacy overhead
costs depends, in part, on the treatment of all drugs and biologicals
each year under our annual drug packaging threshold. Changes to the
packaging threshold may result in changes to payment for the overhead
cost of drugs and biologicals that do not reflect actual changes in
hospital pharmacy overhead cost for those products. For these reasons,
we stated that we believed some portion, but not all, of the total
overhead cost that is associated with coded packaged drugs and
biologicals (the difference between aggregate cost for those drugs and
biologicals on the claims and ASP dollars for the same drugs and
biologicals), based on our standard drug payment methodology, should,
at least for CY 2010, be attributed to separately payable drugs and
biologicals.
We acknowledged that the observed combined payment for acquisition
and pharmacy overhead costs of ASP-2 percent for separately payable
drugs and biologicals may be too low and ASP+247 percent for coded
packaged drugs and biologicals with reported ASP data in the CY 2010
claims data may be too high (74 FR 35327 and 35328). Therefore, we
stated that a middle ground would represent the most accurate
redistribution of pharmacy overhead cost. Our assumption was that
approximately one-third to one-half of the total pharmacy overhead cost
currently associated with coded packaged drugs and biologicals in the
CY 2008 claims data offered a more appropriate allocation of drug and
biological cost to separately payable drugs and biologicals (74 FR
35328). One-third of the $395 million of pharmacy overhead cost
associated with
[[Page 68385]]
packaged drugs and biologicals was $132 million, whereas one-half was
$198 million.
Within the one-third to one-half parameters, we proposed
reallocating $150 million in drug and biological cost observed in the
claims data from coded packaged drugs and biologicals with an ASP to
separately payable drugs and biologicals for CY 2010 for their pharmacy
overhead costs. Based on this redistribution, we proposed a CY 2010
payment rate for separately payable drugs and biologicals of ASP+4
percent.
In the CY 2010 OPPS final rule with comment period, we adopted a
transitional payment rate of ASP+4 percent based on a pharmacy overhead
adjustment methodology for CY 2010 that redistributed $200 million from
packaged drug and biological cost to separately payable drug cost (74
FR 60499 through 60518). This $200 million included the proposed $150
million redistribution from the pharmacy overhead cost of coded
packaged drugs and biologicals for which an ASP is reported and an
additional $50 million dollars from the total uncoded drug and
biological cost to separately payable drugs and biologicals as a
conservative estimate of the pharmacy overhead cost of uncoded packaged
drugs and biologicals that should be appropriately associated with the
cost of separately payable drugs and biologicals (74 FR 60517). We
stated that this was an intentionally conservative estimate as we could
not identify definitive evidence that uncoded packaged drug and
biological cost included a pharmacy overhead amount comparable to that
of coded packaged drugs and biologicals with an ASP. We stated that we
could not know the amount of overhead associated with these drugs
without making significant assumptions about the amount of pharmacy
overhead cost associated with the drugs and biologicals captured by
these uncoded packaged drug costs (74 FR 60511 through 60513). In
addition, as in prior years, we reiterated our commitment to continue
in our efforts to refine our analyses.
For CY 2011, we continued the CY 2010 pharmacy overhead adjustment
methodology (74 FR 60500 through 60512). Consistent with our
supposition that the combined payment for average acquisition and
pharmacy overhead costs under our standard methodology may understate
the cost of separately payable drugs and biologicals and related
pharmacy overhead for those drugs and biologicals, we redistributed
$150 million from the pharmacy overhead cost of coded packaged drugs
and biologicals with an ASP and redistributed $50 million from the cost
of uncoded packaged drugs and biologicals, for a total redistribution
of $200 million from costs for coded and uncoded packaged drugs to
separately payable drugs and biologicals, with the result that we pay
separately paid drugs and biologicals at ASP+5 percent for CY 2011. The
redistribution amount of $150 million in overhead cost from coded
packaged drugs and biologicals with an ASP and $50 million in costs
from uncoded packaged drugs and biologicals without an ASP were within
the parameters established in the CY 2010 OPPS/ASC final rule. In
addition, as in prior years, we described some of our work to improve
our analyses during the preceding year, including an analysis of
uncoded packaged drug and biological cost and our evaluation of the
services with which uncoded packaged drug cost appears in the claims
data. We conducted this analysis in an effort to assess how much
uncoded drugs resemble coded packaged drugs (75 FR 71966). We stated
that, in light of this information, we were not confident that the
drugs captured by uncoded drug cost are the same drugs captured by
coded packaged drug cost, and therefore, we did not believe we could
assume that they are the same drugs, with comparable overhead and
handling costs. Without being able to calculate the ASP for these
uncoded packaged drugs and biologicals and without being able to gauge
the magnitude of overhead complexity associated with these drugs and
biologicals, we did not believe that we should have assumed that the
same amount of proportional overhead should be redistributed between
coded and uncoded packaged drugs, and therefore, we redistributed $50
million from uncoded packaged drugs and $150 million from coded
packaged drugs (75 FR 71966). We reiterated our commitment to continue
to refine our drug pricing methodology and noted that we would continue
to pursue the most appropriate methodology for establishing payment for
drugs and biologicals under the OPPS and continue to evaluate the
appropriateness of this methodology when we establish each year's
payment for drugs and biologicals under the OPPS (75 FR 71967).
For CY 2012, we continued our overhead adjustment methodology of
redistributing \1/3\ to \1/2\ of allocated overhead for coded packaged
drugs or $150 million plus an additional $50 million in allocated
overhead for uncoded packaged drugs. Additionally, we finalized a
policy to update these amounts by the PPI for pharmaceuticals and
redistributed $161 million in allocated overhead from coded packaged
drugs and $54 million from uncoded packaged drugs. We further finalized
a policy to hold the redistributed proportion of packaged drugs
constant between the proposed and the final rule, which increased the
final redistribution amount in the CY 2012 final rule to $240.3 million
($169 million from coded packaged drugs and $71.3 million from uncoded
packaged drugs). This approach resulted in a final payment rate of
ASP+4 percent for separately payable drugs.
b. CY 2013 Payment Policy
In reexamining our current drug payment methodology for the CY 2013
OPPS/ASC proposed rule, we reviewed our past efforts to determine an
appropriate payment methodology for drugs and biologicals, as described
above. Since the inception of the OPPS, we have remained committed to
establishing a drug payment methodology that is predictable, accurate,
and appropriate. Pharmacy stakeholders and the hospital community have
also, throughout the years, continually emphasized the importance of
both predictable and accurate payment rates for drugs, noting that a
payment methodology that emphasizes predictability and accuracy leads
to appropriate payment rates that reflect the cost of drugs and
biologicals (including overhead) in HOPDs. Pertinent stakeholders also
have noted that predictable and accurate payment rates minimize the
effect of anomalies in the claims data that may incorrectly influence
the future payment for services. We understand that, with predictable
payment rates, hospitals are better able to plan for the future.
As discussed above, since CY 2006, we have attempted to establish a
drug payment methodology that reflects hospitals' acquisition costs for
drugs and biologicals while taking into account relevant pharmacy
overhead and related handling expenses. We have attempted to collect
more data on hospital overhead charges for drugs and biologicals by
making several proposals that would require hospitals to change the way
they report the cost and charges for drugs. None of these proposals
were adopted due to significant stakeholder concern, including that
hospitals stated that it would be administratively burdensome to report
hospital overhead charges. We established a payment policy for
separately payable drugs and biologicals, authorized by section
1833(t)(14)(A)(iii)(I) of the Act, based on an ASP+X amount that is
calculated by comparing the estimated aggregate cost
[[Page 68386]]
of separately payable drugs and biologicals in our claims data to the
estimated aggregate ASP dollars for separately payable drugs and
biologicals, using the ASP as a proxy for average acquisition cost (70
FR 68642). As we previously stated, we refer to this methodology as our
standard drug payment methodology.
In CY 2010, taking into consideration comments made by the pharmacy
stakeholders and acknowledging the limitations of the reported data due
to charge compression and hospitals' reporting practices, we added an
``overhead adjustment'' (an internal adjustment of the data) by
redistributing cost from coded and uncoded packaged drugs and
biologicals to separately payable drugs in order to provide more
appropriate payments for drugs and biologicals in the HOPD. We
continued this overhead adjustment methodology through CY 2012, and
further refined our overhead adjustment methodology by finalizing a
policy to update the redistribution amount for inflation and keep the
redistribution ratio constant between the proposed rule and the final
rule.
Application of the standard drug payment methodology, with the
overhead adjustment, has always yielded a finalized payment rate in the
range of ASP+4 percent to ASP+6 percent for nonpass-through separately
payable drugs. We believe that the historic ASP+4 to ASP+6 percentage
range is an appropriate payment rate for separately payable drugs and
biologicals administered within the HOPD, including acquisition and
pharmacy overhead and related expenses. However, because of continuing
uncertainty about the full cost of pharmacy overhead and acquisition
cost, based in large part on the limitations of the submitted hospital
charge and claims data for drugs, we are concerned that the continued
use of our current standard drug payment methodology (including the
overhead adjustment) still may not appropriately account for average
acquisition and pharmacy overhead cost and, therefore, may result in
payment rates that are not as predictable, accurate, or appropriate as
they could be.
Section 1833(t)(14)(A)(iii)(II) of the Act requires an alternative
methodology for determining payment rates for SCODs wherein, if
hospital acquisition cost data are not available, payment shall be
equal (subject to any adjustment for overhead costs) to payment rates
established under the methodology described in section 1842(o), section
1847A, or section 1847B of the Act, as calculated and adjusted by the
Secretary as necessary. Considering stakeholder and provider feedback,
continued limitations of the hospital claims and cost data on drugs and
biologicals, and Panel recommendations, in the CY 2013 OPPS/ASC
proposed rule (77 FR 45140), we proposed for CY 2013 to pay for
separately payable drugs and biologicals at ASP+6 percent based on
section 1833(t)(14)(A)(iii)(II) of the Act, hereinafter referred to as
the statutory default.
As noted above, section 1833(t)(14)(A)(iii)(II) of the Act
authorizes the Secretary to calculate and adjust, as necessary, the
average price for a drug in the year established under section 1842(o),
1847A, or 1847B of the Act, as the case may be, in determining payment
for SCODs. Pursuant to sections 1842(o) and 1847A of the Act, physician
Part B drugs are paid at ASP+6 percent. We believe that proposing the
statutory default of ASP+6 percent is appropriate at this time as it
yields increased predictability in payment for separately payable drugs
and biologicals under the OPPS. We believe that ASP+6 percent is an
appropriate payment amount because it is consistent with payment
amounts yielded by our drug payment methodologies over the past 7
years. We proposed that the ASP+6 percent payment amount for separately
payable drugs and biologicals requires no further adjustment, and
represents the combined acquisition and pharmacy overhead payment for
drugs and biologicals for CY 2013.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45140), we proposed
that payments for separately payable drugs and biologicals are included
in the budget neutrality adjustments, under the requirements in section
1833(t)(9)(B) of the Act, and that the budget neutral weight scaler is
not applied in determining payments for these separately paid drugs and
biologicals.
Comment: Commenters strongly supported CMS' proposal to pay for
separately payable drugs and biologicals based on the statutory default
rate of ASP+6 percent. The commenters stated that ASP+6 percent is
administratively simple, improves stability of drug and biological
payments, and better covers the costs of drug acquisition and pharmacy
overhead than the payment rates CMS has finalized in previous years.
The commenters noted that, by contrast, the current payment methodology
involves complex calculations and an annual overhead adjustment in
which costs are redistributed from packaged drugs to separately payable
drugs. Another commenter supported CMS' proposal to pay for separately
payable drugs and biologicals because it believed that this change in
the payment methodology will prevent the inappropriate shifting of
overhead costs from contrast agents. One commenter also expressed
support for the proposal and noted the importance of finalizing the
proposal, as more hospitals seek to access preferred drug pricing under
the 340B program.
One commenter noted that the implementation of the survey of
hospital drug costs required by section 1833(t)(14)(D)(iii), instead of
the proposed statutory default rate of ASP+6 percent, would impose a
costly administrative burden on both hospitals and CMS without
demonstrating an equivalent benefit compared to the use of the average
sales price that is based on the certified sales price of the drugs and
biologicals. Other commenters supported CMS' proposal to pay for drugs
and biologicals at ASP+6 percent because neither the GAO nor CMS have
conducted the periodic surveys required by the statute since CY 2005 on
average acquisition costs. They argued that, in the absence of current
survey data on average acquisition costs, the statute requires that
payment be set at the statutory default rate of ASP+6 percent and that
an additional adjustment for overhead be made.
Several commenters agreed with CMS and noted that this proposal
allowed for stable and predictable payment rates for separately paid
drugs and biologicals while removing the need to address charge
compression and other issues. One commenter noted, in particular, that
the proposal eliminates the issues related to the inclusion of 340B
sales in the rate calculation. The commenter further recommended that
CMS continue its policy of paying 340B and non-340B hospitals at the
same rate for separately paid drugs and biologicals. Other commenters
noted that payment for the acquisition and overhead costs of drugs and
biologicals at ASP+6 percent will help to protect patients' access to
care in the most clinically appropriate setting. The commenters also
argued that this payment rate would create parity with the physician
office setting.
Finally, many of the comments supported CMS' goal to establish a
payment methodology that accurately and predictably estimates
acquisition and overhead costs for separately paid drugs and
biologicals.
Response: We appreciate the commenters' support. For several years,
we have attempted to identify a methodology for paying for the average
acquisition cost and pharmacy overhead costs for SCODs in a manner that
is both appropriate and that is not burdensome
[[Page 68387]]
to hospitals. After several years of refining a payment methodology,
which has included the standard payment methodology and the overhead
adjustment methodology, we determined in the CY 2013 OPPS/ASC proposed
rule (77 FR 45140) that, because of continuing uncertainty about the
full cost of pharmacy overhead and acquisition cost, based in large
part on the limitations of the submitted hospital charge and claims
data for drugs, the continued use of our current standard drug payment
methodology (including the overhead adjustment) still may not
appropriately account for average acquisition and pharmacy overhead
cost and therefore may result in payment rates that are not as
predictable, accurate, or appropriate as they could be. Therefore, we
proposed to pay for separately payable drugs and biologicals at the
statutory default rate of ASP+6 percent, as is consistent with section
1833(t)(14)(iii)(II) of the Act which requires an alternative
methodology for determining payment rates for SCODs wherein, if
hospital acquisition cost data are not available, payment shall be
equal (subject to any adjustment for overhead costs) to the payment
rates established under the methodology described in section 1842(o),
section 1847A, or section 1847B of the Act, as calculated and adjusted
by the Secretary as necessary.
In the past, commenters, pertinent stakeholders, and the HOP Panel
(previously known as the APC Panel) have strongly advocated for the use
of the statutory default payment rate of ASP+6 percent. As we stated in
the proposed rule, we believe that our proposal is consistent with
these previous comments and we agree with the commenters that proposing
a payment rate of ASP+6 percent based on the statutory default for
separately payable drugs and biologicals is appropriate at this time.
We agree with commenters that the statutory default obviates both the
need to utilize complex calculations for acquisition and overhead costs
and the requirement to collect data from hospital surveys, which would
prove to be burdensome to both hospitals and to CMS. Additionally, we
agree with commenters that the statutory default payment rate of ASP+6
percent eliminates the 340B program concerns many commenters have
expressed in the past. Therefore, we believe that the statutory default
payment rate of ASP+6 percent is appropriate for CY 2013.
Comment: Several commenters supported CMS' proposal of ASP+6
percent but stated their concerns that this level of payment is not
sufficient to cover both drug acquisition and pharmacy overhead cost.
The commenters stated that they considered this an improvement over the
rate used in previous years and that this payment rate should be the
minimum level of payment, or the payment floor, necessary to cover
acquisition costs alone. Therefore, the commenters recommended that CMS
finalize ASP+6 percent as the payment rate for acquisition costs alone
and provide an additional, separate payment for hospital pharmacy
overhead costs. One commenter also expressed concern whether ASP+6
percent is sufficient to cover both acquisition and handling. However,
the commenter stated that the ASP+6 percent proposed payment rate is
preferable to CMS continuing to attempt to determine what level of
redistribution from packaged drugs to separately payable drugs should
occur on an annual basis. One commenter reaffirmed the notion that
ASP+6 percent should be the minimum level of payment that should be
provided to cover hospitals' drug acquisition costs but the commenter
recommended that CMS reconsider ASP+6 percent to be the minimum payment
level to cover drug acquisition costs in both the physician's office
and the hospital outpatient setting. The commenter argued that this
would create payment parity and also enable the creation of a
supplemental system to make a separate and additional ASP plus
percentage amount to hospitals to cover their significant overhead
costs.
One commenter supported CMS' proposal and stated that if CMS should
finalize its policy to pay for separately payable drugs and biologicals
at ASP+6 percent, CMS should not pay for pharmacy overhead, which is
permitted but not required by section 1833(t)(14)(E)(iii) of the Act,
in addition to the ASP+6 percent payment because payment at ASP+6
percent already includes payment for pharmacy overhead equal to 5
percent of ASP (the difference between ASP+6 percent and the ASP+1
percent that the OIG found to be the average acquisition cost of
hospital drugs and biologicals in a study conducted by the OIG in 2010)
(https://oig.hhs.gov/oei/reports/oei-03-09-00420.pdf). Moreover, the
commenter further noted that payment for separately payable drugs and
biologicals under section 1842(o) of the Act at 106 percent of ASP
includes payment for the services of the pharmacy from which the
physician purchases the drugs and biologicals. Therefore, the commenter
further noted, if CMS pays hospitals ASP+6 percent for separately paid
drugs and biologicals, it is also paying for the associated pharmacy
overhead and should pay nothing more.
Response: We disagree with the commenters who stated that ASP+6
percent should be the payment for the acquisition cost alone and that
separate payment for overhead should be made. We note that while the
statute states that payment for SCODs under section
1833(t)(14)(A)(iii)(II) of the Act equals the payment rates established
in the physician's office, subject to any adjustment for overhead
costs, the statute does not mandate that such an adjustment for
overhead be made. We believe that the payment rate of ASP+6 percent
includes a sufficient amount for overhead costs for separately payable
drugs and biologicals and we see no further evidence that any
additional adjustment for overhead is required. As we stated in the
proposed rule, we believe that the historic ASP+4 to ASP+6 percentage
range is an appropriate payment rate for separately payable drugs and
biologicals administered within the HOPD, including acquisition and
pharmacy overhead and related expenses, and we have not seen any
evidence to indicate that these rates have limited beneficiary access
to drugs, insufficiently paid for acquisition and overhead costs for
drugs administered in the HOPD, or caused a migration of care from the
hospital outpatient setting to the physician's office. To the contrary,
we continue to see increases in the utilization of drugs and
biologicals administered in the outpatient department in our claims
data, even at payment rates of ASP+4 or 5 percent. Therefore, we
believe that ASP+6 percent is an appropriate payment rate for
separately payable drugs and biologicals.
Additionally, we agree with the commenter who cited the OIG study
conducted in 2010, which used first quarter 2009 Medicare payment
amounts compared to first quarter 2009 hospital acquisition costs for
33 separately payable drugs. The OIG concluded that, in the aggregate,
Medicare payments were 1 percent higher than acquisition costs amounts
for the responding non-340B hospitals for the selected separately
payable drugs. This study supports our position that the ASP+6
percentage amount proposed for CY 2013 sufficiently pays for overhead
and acquisition costs for drugs and requires no further adjustment.
We continue to believe that ASP+6 percent based on the statutory
default is appropriate for hospitals for CY 2013 and that this
percentage amount
[[Page 68388]]
includes payment for acquisition and overhead cost. Furthermore, many
hospitals and major hospital associations supported our proposed ASP+6
percent for CY 2013 and made no request for additional payment for
overhead costs in their comments to the CY 2013 OPPS/ASC proposed rule.
Therefore, we believe that a payment rate of ASP+6 percent is
appropriate for CY 2013.
Comment: A few commenters supported CMS' proposal, but recommended
that CMS examine ways to compensate hospitals for the unique, higher
overhead and handling costs associated with therapeutic
radiopharmaceuticals.
Response: As we stated above, we continue to believe that ASP+6
percent based on the statutory default is appropriate for hospitals for
CY 2013 and that this percentage amount includes payment for
acquisition and overhead cost. We see no evidence that an additional
overhead adjustment is required for separately payable drugs,
biologicals and therapeutic radiopharmaceuticals for CY 2013.
Comment: One commenter remained concerned that the comparison of
ASP to cost is not an ``apple to apples'' comparison because the cost
data incorporate data from hospitals that receive 340B program
discounts from drugs they purchase. The commenter further stated that
the ASP calculation excludes 340B program sales, which underestimates
the aggregate costs of drugs for most hospitals and the ASP-based rate
that CMS produces by comparing aggregate costs to ASP is too low. The
commenter asked that CMS review its cost calculation to ASP to ensure
that 340B program drugs are not artificially reducing the CMS
calculation.
Response: For CY 2013, we proposed to pay for separately payable
drugs and biologicals at ASP+6 percent based on the statutory default
established in section 1833(t)(14)(A)(iii)(II) of the Act. While we
understand that commenters were previously concerned about the impact
of 340B hospital data on our previous standard and overhead adjustment
methodology calculations, we did not in fact propose to continue these
methodologies for CY 2013.
Comment: One commenter supported CMS' proposal to increase the
payment rate for SCODs to ASP+6 percent for CY 2013. However, the
commenter believed that the law requires that SCOD payment rates, other
than the ASP+6 percent default rate, must be set on a drug by drug
basis, as mandated by section 1833(t)(14)(A)(iii)(I) of the Act.
Therefore, the commenter recommended that CMS perform an
individualized, drug by drug determination for the payment rate for
each SCOD.
Response: Section 1833(t)(14)(A)(iii)(I) of the Act requires that
payment for SCODs in CY 2006 and subsequent years be equal to the
average acquisition cost for the drug for that year, subject to any
adjustment of overhead costs. If hospital acquisition cost data are not
available, section 1833(t)(14)(A)(iii)(II) of the Act requires that
payment be equal to payment rates established under the methodology
described in section 1842(o), section 1847A, or section 1847B of the
Act, as calculated and adjusted by the Secretary as necessary.
Previously under the standard methodology and the overhead adjustment
methodology, we established ASP as a proxy for the average acquisition
cost. However, we did not propose to use the authority given under
section 1833(t)(14)(A)(iii)(I) of the Act to pay for SCODs for CY 2013.
For CY 2013, we instead proposed to pay for separately payable drugs
and biologicals based on the statutory authority established in section
1833(t)(14)(A)(iii)(II) of the Act.
Comment: One commenter recommended that CMS design a payment
strategy that would maintain one formula for health care prescribers,
but develop a multi-tiered reimbursement strategy that would encourage
the use of generic drugs over their branded counterparts, using ASP+6
percent as an appropriate base for the most expensive drugs and
providing additional reimbursement for multi-source generic drugs.
Another commenter recommended that CMS adopt a new policy of assigning
each ``branded prescription drug'' a unique HCPCS code, so that Part B
utilization of these drugs can be accurately determined.
Response: We made no such proposal to develop a multi-tiered
payment strategy that would encourage the use of generic drugs over
their branded counterparts, using ASP+6 percent as an appropriate base
for the most expensive drugs and providing additional payment for
multi-source generic drugs. The commenters' recommendation to assign a
unique HCPCS code for each ``branded prescription drug'' is outside the
scope of this final rule with comment period.
Comment: One commenter asked that, for CY 2014, CMS consider paying
for influenza and PPV vaccines at 106 percent of ASP.
Response: This comment is outside the scope of the CY 2013 OPPS/ASC
final rule. However, we plan to address this issue in an upcoming
rulemaking cycle.
Comment: One commenter supported CMS' proposal to pay for
separately payable drugs at ASP+6 percent, but the commenter urged CMS
to consider the effect of its coding practices on brand manufacturers'
annual fee payment under section 9008 of the Patient Protection and
Affordable Care Act (ACA) and asked that CMS support the exclusion of
wholesaler prompt pay discounts from the ASP calculations of separately
payable drugs.
Response: Comments about individual ASP calculations for drugs and
biologicals, or the inclusion or exclusion of prompt pay discounts in
these calculations, are outside the scope of this final rule with
comment period.
At its February 2012 Panel meeting, the Panel made four
recommendations on drugs and biologicals paid under the OPPS. First,
the Panel recommended that CMS require hospitals to bill all drugs that
are described by Healthcare Common Procedure Coding System (HCPCS)
codes under revenue code 0636. While we agree that drugs and
biologicals may be reported under revenue code 0636, we believe that
drugs and biologicals may also be appropriately reported in revenue
code categories other than revenue code 0636, including but not limited
to, revenue codes 025x and 062x. As we stated in the CY 2011 OPPS/ASC
final rule with comment period (75 FR 71966), we recognize that
hospitals may carry the costs of drugs and biologicals in multiple cost
centers and that it may not be appropriate to report the cost of all
drugs and biologicals in one specified revenue code. Additionally, we
generally require hospitals to follow National Uniform Billing
Committee (NUBC) guidance for the choice of an appropriate revenue code
that is also appropriate for the hospital's internal accounting
processes. Therefore, we are not accepting the Panel's recommendation
to require hospitals to bill all drugs that are described by HCPCS
codes under revenue code 0636. However, we continue to believe that
OPPS ratesetting is most accurate when hospitals report charges for all
items and services that have HCPCS codes using those HCPCS codes,
regardless of whether payment for the items and services is packaged.
It is our standard ratesetting methodology to rely on hospital cost
report and charge information as it is reported to us through the
claims data. We continue to believe that more complete data from
hospitals identifying the specific drugs that were provided during an
episode of care may improve payment accuracy for
[[Page 68389]]
drugs in the future. Therefore, we continue to encourage hospitals to
change their reporting practices if they are not already reporting
HCPCS codes for all drugs and biologicals furnished, when specific
HCPCS codes are available for those drugs and biologicals.
Comment: Some commenters recommended that CMS require hospitals to
bill all drugs with HCPCS codes under revenue code 0636 in order to
improve its data on packaged drugs. One commenter recommended that CMS
not require hospitals to report the HCPCS code for each drug and
biological in revenue code 0636 because to do so would impose an
unreasonable burden on hospitals without a commensurate benefit to the
accuracy of Medicare payment for drugs and biologicals under the OPPS
if CMS finalizes its proposal to pay separately paid drugs at ASP+6
percent. Moreover, the commenter continued, in the case of packaged
drugs and biologicals, the charges that are reported with revenue codes
but without HCPCS codes are reduced to costs by application of the CCR
for the cost center that applies to the revenue code under which the
charges are reported and are packaged into the cost of the service. The
commenter further stated that, therefore, to require that all drugs and
biologicals be reported under any specific revenue code would require
hospitals to revise their cost accounting systems to accommodate such a
change because the revenue code in which charges are reported must
correspond to the cost center in which the costs are reported on the
cost report for the cost report to be completed correctly and for the
cost of packaged drugs and biologicals to be calculated correctly.
Response: We do not accept the commenter's recommendation that CMS
require drugs and biologicals to be reported under revenue code 0636.
We do agree with the commenter who recommended that CMS not require
hospitals to report the HCPCS code for each drug and biological in
revenue code 0636 because doing so would impose an unreasonable burden
on hospitals. Further, we agree that charges that are reported with
revenue codes but without HCPCS codes are reduced to costs by
application of the CCR for the cost center that applies to the revenue
code under which the charges are reported and are packaged into the
cost of the service. As we stated in the CY 2013 OPPS/ASC proposed
rule, we believe that drugs and biologicals may also be appropriately
reported in revenue code categories other than revenue code 0636,
including, but not limited to, revenue codes 025x and 062x. As we
stated in the CY 2011 OPPS/ASC final rule with comment period (75 FR
71966), we recognize that hospitals may carry the costs of drugs and
biologicals in multiple cost centers and that it may not be appropriate
to report the cost of all drugs and biologicals in one specified
revenue code. Additionally, we generally require hospitals to follow
National Uniform Billing Committee (NUBC) guidance for the choice of an
appropriate revenue code that is also appropriate for the hospital's
internal accounting processes. Therefore, we are not accepting the
Panel's recommendation to require hospitals to bill all drugs that are
described by HCPCS codes under revenue code 0636.
However, we are reiterating once again in this CY 2013 OPPS/ASC
final rule with comment period that the OPPS ratesetting as a whole,
not just for drugs and biologicals, is most accurate when hospitals
report charges for all items and services that have HCPCS codes using
those HCPCS codes, regardless of whether payment for the items and
services is packaged. Therefore, we continue to encourage hospitals to
report a charge for each service they furnish, either by billing the
HCPCS code and a charge for that service if separate reporting is
consistent with CPT and CMS instructions or by reporting the charge for
the packaged service with an appropriate revenue code but without a
HCPCS code, when specific HCPCS codes are unavailable.
Second, the Panel recommended that CMS exclude data from hospitals
that participate in the 340B program from its ratesetting calculations
for drugs. Under the proposed statutory default payment rate of ASP+6
percent, hospitals' 340B status does not affect the drug payment rate.
Third, the Panel recommended that CMS freeze the packaging
threshold at $75 until the drug payment issue is more equitably
addressed. The OPPS is based on the concept of payment for groups of
services that share clinical and resource characteristics. We believe
that the packaging threshold is reasonable based on the initial
establishment in law of a $50 threshold for the CY 2005 OPPS, that
updating the $50 threshold is consistent with industry and government
practices, and that the PPI for Prescription Drugs is an appropriate
mechanism to gauge Part B drug inflation. Therefore, we are not
accepting the Panel's recommendation to freeze the packaging threshold
at $75 until the drug payment issue is more equitably addressed.
Instead, as discussed in section V.B.2. of the proposed rule and this
final rule with comment period, we proposed and are finalizing an OPPS
drug packaging threshold for CY 2013 of $80. However, we do believe
that we have addressed the drug payment issue by proposing to pay for
separately paid drugs and biologicals at ASP+6 percent for CY 2013
based upon the statutory default.
Finally, the Panel recommended that CMS pay hospitals for
separately payable drugs at a rate of ASP+6 percent. This Panel
recommendation is consistent with our CY 2013 proposed payment rate
based upon the statutory default under section 1833(t)(14)(A)(iii)(II)
of the Act, which authorizes us to pay for drugs and biologicals under
the OPPS at ASP+6 percent, when hospital acquisition cost data are not
available.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to pay for separately
payable drugs and biologicals at ASP+6 percent based on section
1833(t)(14)(A)(iii)(II) of the Act, hereinafter referred to as the
statutory default. The ASP+6 percent payment amount for separately
payable drugs and biologicals requires no further adjustment and
represents the combined acquisition and pharmacy overhead payment for
drugs and biologicals for CY 2013. As we stated in the proposed rule
(77 FR 45140), our goals continue to be to develop a methodology that
accurately and predictably estimates acquisition and overhead costs for
separately payable drugs and biologicals in order to pay for them
appropriately. If a better payment methodology is developed in the
future then the proposed policy to pay ASP+6 percent according to the
statutory default would be an interim step in the development of this
payment policy. We recognize the challenges in doing so given the
current data sources and the object of maintaining the smallest
administrative burden possible.
In addition, we are finalizing our proposal which states that
payment for separately payable drugs and biologicals be included in the
budget neutrality adjustments, under the requirements of section
1833(t)(9)(B) of the Act, and that the budget neutral weight scaler is
not applied in determining payment of these separately paid drugs and
biologicals.
We note that separately payable drug and biological payment rates
listed in Addenda A and B to this final rule with comment period, which
illustrate the final CY 2013 payment of ASP+6 percent for separately
payable nonpass-
[[Page 68390]]
through drugs and biologicals and ASP+6 percent for pass-through drugs
and biologicals, reflect either ASP information that is the basis for
calculating payment rates for drugs and biologicals in the physician's
office setting effective October 1, 2012, or WAC, AWP or mean unit cost
from 2011 claims data and updated cost report information available for
this final rule with comment period. In general, these published
payment rates are not reflective of actual January 2013 payment rates.
This is because payment rates for drugs and biologicals with ASP
information for January 2013 will be determined through the standard
quarterly process where ASP data submitted by manufacturers for the
third quarter of 2012 (July 1, 2012 through September 30, 2012) are
used to set the payment rates that are released for the quarter
beginning in January 2013 near the end of December 2012. In addition,
payment rates for drugs and biologicals in Addenda A and B to this
final rule with comment period for which there was no ASP information
available for October 2012 are based on mean unit cost in the available
CY 2011 claims data. If ASP information becomes available for payment
for the quarter beginning in January 2013, we will price payment for
these drugs and biologicals based on their newly available ASP
information. Finally, there may be drugs and biologicals that have ASP
information available for this final rule with comment period
(reflecting October 2012 ASP data) that do not have ASP information
available for the quarter beginning in January 2013. These drugs and
biologicals will then be paid based on mean unit cost data derived from
CY 2011 hospital claims. Therefore, the payment rates listed in Addenda
A and B to this final rule with comment period are not for January 2013
payment purposes and are only illustrative of the CY 2013 OPPS payment
methodology using the most recently available information at the time
of issuance of this final rule with comment period.
4. Payment Policy for Therapeutic Radiopharmaceuticals
Beginning in CY 2010 and continuing for CY 2012, we established a
policy to pay for separately paid therapeutic radiopharmaceuticals
under the ASP methodology adopted for separately payable drugs and
biologicals. We allow manufacturers to submit the ASP data in a
patient-specific dose or patient-ready form in order to properly
calculate the ASP amount for a given HCPCS code. If ASP information is
unavailable for a therapeutic radiopharmaceutical, then we base
therapeutic radiopharmaceutical payment on mean unit cost data derived
from hospital claims. We believe that the rationale outlined in the CY
2010 OPPS/ASC final rule with comment period (74 FR 60524 through
60525) for applying the principles of separately payable drug pricing
to therapeutic radiopharmaceuticals continues to be appropriate for
nonpass-through separately payable therapeutic radiopharmaceuticals in
CY 2013. Therefore, in the CY 2013 OPPS/ASC proposed rule (77 FR
45141), we proposed for CY 2013 to pay all nonpass-through, separately
payable therapeutic radiopharmaceuticals at ASP+6 percent, based on the
statutory default described in section 1833(t)(14)(A)(iii)(II) of the
Act. We proposed to continue to set payment rates for therapeutic
radiopharmaceuticals based on ASP information, if available, for a
``patient ready'' dose and updated on a quarterly basis for products
for which manufacturers report ASP data. For a full discussion of how a
``patient ready'' dose is defined, we refer readers to the CY 2010
OPPS/ASC final rule with comment period (74 FR 60520 through 60521). We
also proposed to rely on CY 2011 mean unit cost data derived from
hospital claims data for payment rates for therapeutic
radiopharmaceuticals for which ASP data are unavailable and to update
the payment rates for separately payable therapeutic
radiopharmaceuticals, according to our usual process for updating the
payment rates for separately payable drugs and biologicals, on a
quarterly basis if updated ASP information is available. For a complete
history of the OPPS payment policy for therapeutic
radiopharmaceuticals, we refer readers to the CY 2005 OPPS final rule
with comment period (69 FR 65811), the CY 2006 OPPS final rule with
comment period (70 FR 68655), and the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60524).
Comment: Commenters supported CMS' proposal to pay for separately
payable therapeutic radiopharmaceuticals under the statutory default
payment rate of ASP+6 percent, if ASP data is submitted to CMS. The
commenters also supported CMS' proposal to continue to set payment
rates for therapeutic radiopharmaceuticals based on ASP information, if
available, for a ``patient ready'' dose. One commenter recommended that
CMS use its discretion and continue to pay on the basis of hospital
specific reasonable cost-finding where ASP information is not
available.
Response: We appreciate the commenters' support. We continue to
believe that providing payment for therapeutic radiopharmaceuticals
based on ASP or mean unit cost if ASP information is not available
would provide appropriate payment for these products. When ASP data are
not available, we believe that paying for therapeutic
radiopharmaceuticals using mean unit cost would appropriately pay for
the average hospital acquisition and associated handling costs of
nonpass-through separately payable therapeutic radiopharmaceuticals. As
we stated in the CY 2010 OPPS/ASC final rule with comment period (74 FR
60523), although using mean unit cost for payment for therapeutic
radiopharmaceuticals when ASP data are not available is not the usual
OPPS process (the usual process relies on alternative data sources such
as WAC or AWP when ASP information is temporarily unavailable, prior to
defaulting to the mean unit cost from hospital claims data), we
continue to believe that WAC or AWP is not an appropriate proxy to
provide OPPS payment for average therapeutic radiopharmaceutical
acquisition cost and associated handling costs when manufacturers are
not required to submit ASP data. In addition, we do not believe that we
should provide payment at charges reduced to cost or reasonable cost
when ASP data are not available. We have stated previously, in the CY
2008 OPPS/ASC final rule with comment period, that we continue to
believe that payment on a claims-specific basis is not consistent with
the payment of times and services on a prospective basis under the OPPS
and may lead to extremely high or low payment to hospitals for
radiopharmaceuticals, even when those products would be expected to
have relatively predictable and consistent acquisition and holding
costs across individual clinical cases and hospitals. For CY 2013,
Medicare pays for only a few outpatient services at reasonable cost.
These services include, but are not limited to, corneal tissue
acquisition and influenza vaccines, and are paid at reasonable cost in
part because the input costs for future years are highly unpredictable
and to set a prospective payment rate for them may result in payment
that is so deficient that hospitals would not be able to provide the
services and the general public could be denied the benefits. In
particular, it is not possible to forecast with confidence what the
cost of
[[Page 68391]]
influenza vaccine would be a year in advance because the composition of
the vaccine is not constant from year to year. In contrast, however,
the input costs of therapeutic radiopharmaceuticals are not hugely
unpredictable. Therefore, we do not believe that therapeutic
radiopharmaceuticals should be paid in the same manner as the few
outpatient services paid at reasonable cost. We continue to believe
that when ASP data are unavailable, therapeutic radiopharmaceutical
payment based on mean unit cost is an appropriate proxy for hospitals'
acquisition and handling data.
Comment: One commenter requested that CMS create a HCPCS J-code for
tositumomab, currently provided under a radioimmunotherapy regimen and
billed as part of HCPCS code G3001 (Administration and supply of
tositumomab, 450 mg). The commenter argued that because tositumomab is
approved by the FDA as part of the BEXXAR[supreg] regimen and has its
own National Drug Code (NDC), it should be recognized as a drug and,
therefore, be paid as other drugs are paid under the OPPS methodology,
instead of having a payment rate determined by hospital claims data.
The commenter recommended that payment for all of the BEXXAR[supreg]
drug components be paid as a SCOD.
Response: We have consistently noted that unlabeled tositumomab is
not approved as either a drug or a radiopharmaceutical. It is a supply
that is required as part of the radioimmunotherapy treatment regimen
(as noted in the CY 2009 OPPS/ASC final rule with comment period (73 FR
68658), the CY 2008 OPPS final rule with comment period (72 FR 66765),
the CY 2006 OPPS final rule with comment period (70 FR 68654), and the
CY 2004 OPPS final rule with comment period (68 FR 63443)). We do not
make separate payment for supplies used in services provided under the
OPPS. Payments for necessary supplies are packaged into payments for
the separately payable services provided by the hospital. Payment for
unlabeled tositumomab is included in the payment for the administration
procedure (described by HCPCS code G3001). Therefore, we do not agree
with the commenter's recommendation that we should assign a separate
HCPCS code to unlabeled tositumomab, which is a packaged supply.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to continue to pay all
nonpass-through, separately payable therapeutic radiopharmaceuticals
based on ASP information, if available, for a ``patient ready'' dose
and updated on a quarterly basis for products for which manufacturers
report ASP data. For CY 2013, therapeutic radiopharmaceuticals will be
paid based on the statutory default payment rate of ASP+6 percent. The
final CY 2013 payment rates for nonpass-through separately payable
therapeutic radiopharmaceuticals are included in Addenda A and B to the
proposed rule (which is available via the Internet on the CMS Web
site).
5. Payment for Blood Clotting Factors
For CY 2012, we provided payment for blood clotting factors under
the same methodology as other nonpass-through separately payable drugs
and biologicals under the OPPS and continued paying an updated
furnishing fee. That is, for CY 2012, we provided payment for blood
clotting factors under the OPPS at ASP+4 percent, plus an additional
payment for the furnishing fee. We note that when blood clotting
factors are provided in physicians' offices under Medicare Part B and
in other Medicare settings, a furnishing fee is also applied to the
payment. The CY 2012 updated furnishing fee is $0.181 per unit.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45141), we proposed to
pay for blood clotting factors at ASP+6 percent, consistent with our
proposed payment policy for other nonpass-through separately payable
drugs and biologicals, and to continue our policy for payment of the
furnishing fee using an updated amount. Our policy to pay for a
furnishing fee for blood clotting factors under the OPPS is consistent
with the methodology applied in the physician office and inpatient
hospital setting, and first articulated in the CY 2006 OPPS final rule
with comment period (70 FR 68661) and later discussed in the CY 2008
OPPS/ASC final rule with comment period (72 FR 66765). The proposed
furnishing fee update was based on the percentage increase in the
Consumer Price Index (CPI) for medical care for the 12-month period
ending with June of the previous year. Because the Bureau of Labor
Statistics releases the applicable CPI data after the MPFS and OPPS/ASC
proposed rules are published, we were not able to include the actual
updated furnishing fee in the proposed rules. Therefore, in accordance
with our policy, as finalized in the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66765), we proposed to announce the actual figure
for the percent change in the applicable CPI and the updated furnishing
fee calculated based on that figure through applicable program
instructions and posting on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
Comment: Commenters supported CMS' proposal to continue to apply
the furnishing fee for blood clotting factors provided in the OPD. One
commenter stated that the furnishing fee helps ensure patient access to
blood clotting factors by increasing the payment rate for these items.
These commenters also supported CMS' proposal to pay for separately
payable drugs at ASP+6 percent based on the statutory default, for CY
2013.
Response: We appreciate the commenters' support. We continue to
believe that applying the furnishing fee for blood clotting factors is
appropriate for CY 2013. In addition, because we recognize that there
is additional work involved in acquiring the product that is neither
acquisition cost nor pharmacy overhead, we believe that it continues to
be appropriate to pay a furnishing fee for blood clotting factors under
the OPPS as is done in the physician's office setting and the inpatient
hospital setting. Additionally, for the reasons discussed in section
V.B.3. of this final rule with comment period, we agree with the
commenters that ASP+6 percent based on the statutory default is an
appropriate payment rate for CY 2013.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to provide payment for
blood clotting factors under the same methodology as other separately
payable drugs and biologicals under the OPPS and to continue payment of
an updated furnishing fee. We will announce the actual figure of the
percent change in the applicable CPI and the updated furnishing fee
calculation based on that figure through the applicable program
instructions and posting on the CMS Web site.
6. Payment for Nonpass-Through Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes but Without OPPS Hospital Claims
Data
The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Pub. L. 108-173) did not address the OPPS payment in CY 2005
and after for drugs, biologicals, and radiopharmaceuticals that have
assigned HCPCS codes, but that do not have a reference AWP or approval
for payment as pass-through drugs or biologicals. Because there is no
statutory provision that dictated payment for such drugs,
[[Page 68392]]
biologicals, and radiopharmaceuticals in CY 2005, and because we had no
hospital claims data to use in establishing a payment rate for them, we
investigated several payment options for CY 2005 and discussed them in
detail in the CY 2005 OPPS final rule with comment period (69 FR 65797
through 65799).
For CYs 2005 to 2007, we implemented a policy to provide separate
payment for new drugs, biologicals, and radiopharmaceuticals with HCPCS
codes (specifically those new drug, biological, and radiopharmaceutical
HCPCS codes in each of those calendar years that did not crosswalk to
predecessor HCPCS codes) but which did not have pass-through status, at
a rate that was equivalent to the payment they received in the
physician's office setting, established in accordance with the ASP
methodology for drugs and biologicals, and based on charges adjusted to
cost for radiopharmaceuticals. For CYs 2008 and 2009, we finalized a
policy to provide payment for new drugs (excluding contrast agents and
diagnostic radiopharmaceuticals) and biologicals (excluding implantable
biologicals for CY 2009) with HCPCS codes, but which did not have pass-
through status and were without OPPS hospital claims data, at ASP+5
percent and ASP+4 percent, respectively, consistent with the final OPPS
payment methodology for other separately payable drugs and biologicals.
New therapeutic radiopharmaceuticals were paid at charges adjusted to
cost based on the statutory requirement for CY 2008 and CY 2009 and
payment for new diagnostic radiopharmaceuticals was packaged in both
years.
For CY 2010, we continued to provide payment for new drugs
(excluding contrast agents) and nonimplantable biologicals with HCPCS
codes that do not have pass-through status and are without OPPS
hospital claims data at ASP+4 percent, consistent with the CY 2010
payment methodology for other separately payable nonpass-through drugs
and nonimplantable biologicals. We also finalized a policy to extend
the CY 2009 payment methodology to new therapeutic radiopharmaceutical
HCPCS codes, consistent with our final policy in the CY 2010 OPPS/ASC
final rule with comment period (74 FR 60581 through 60526), providing
separate payment for therapeutic radiopharmaceuticals that do not
crosswalk to CY 2009 HCPCS codes, do not have pass-through status, and
are without OPPS hospital claims data at ASP+4 percent. This policy was
continued in the CY 2011 OPPS/ASC final rule with comment period (75 FR
71970 through 71973), paying for new drugs, nonimplantable biologicals,
and radiopharmaceuticals that do not crosswalk to CY 2010 HCPCS codes,
do not have pass-through status, and are without OPPS hospital claims
data at ASP+5 percent and the CY 2012 OPPS/ASC final rule with comment
period at ASP+4 percent (76 FR 74330 through 74332).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45142), we proposed to
provide payment for new CY 2013 drugs (excluding contrast agents and
diagnostic radiopharmaceuticals), nonimplantable biologicals, and
therapeutic radiopharmaceuticals, at ASP+6 percent, consistent with the
proposed CY 2013 payment methodology for other separately payable
nonpass-through drugs, nonimplantable biologicals, and therapeutic
radiopharmaceuticals to pay at ASP+6 percent based on the statutory
default. We believe this proposed policy would ensure that new nonpass-
through drugs, nonimplantable biologicals and therapeutic
radiopharmaceuticals would be treated like other drugs, nonimplantable
biologicals, and therapeutic radiopharmaceuticals under the OPPS.
We also proposed to continue to package payment for all new
nonpass-through diagnostic radiopharmaceuticals and contrast agents
with HCPCS codes but without claims data (those new CY 2013 diagnostic
radiopharmaceuticals, contrast agents, and implantable biological HCPCS
codes that do not crosswalk to predecessor HCPCS codes). This is
consistent with the proposed policy packaging all existing nonpass-
through diagnostic radiopharmaceuticals and contrast agents, as
discussed in more detail in section II.A.3.g. of this final rule with
comment period.
In accordance with the OPPS ASP methodology, in the absence of ASP
data, for CY 2013, we proposed to continue the policy we implemented
beginning in CY 2005 of using the WAC for the product to establish the
initial payment rate for new nonpass-through drugs and biologicals with
HCPCS codes, but which are without OPPS claims data and are not
diagnostic radiopharmaceuticals and contrast agents. However, we noted
that if the WAC is also unavailable, we would make payment at 95
percent of the product's most recent AWP. We also proposed to assign
status indicator ``K'' (for separately paid nonpass-through drugs and
nonimplantable biologicals, including therapeutic radiopharmaceuticals)
to HCPCS codes for new drugs and nonimplantable biologicals without
OPPS claims data and for which we have not granted pass-through status.
With respect to new, nonpass-through drugs, nonimplantable biologicals,
and therapeutic radiopharmaceuticals for which we do not have ASP data,
we proposed that once their ASP data become available in later
quarterly submissions, their payment rates under the OPPS would be
adjusted so that the rates would be based on the ASP methodology and
set to the finalized ASP-based amount (proposed for CY 2013 at ASP+6
percent) for items that have not been granted pass-through status. This
proposed policy, which utilizes the ASP methodology that requires us to
use WAC data when ASP data are unavailable and 95 percent of AWP when
WAC and ASP data are unavailable, for new nonpass-through drugs and
biologicals with an ASP, is consistent with prior years' policies for
these items, and would ensure that new nonpass-through drugs,
nonimplantable biologicals, and therapeutic radiopharmaceuticals would
be treated like other drugs, nonimplantable biologicals, and
therapeutic radiopharmaceuticals under the OPPS, unless they are
granted pass-through status.
Similarly, we proposed to continue to base the initial payment for
new therapeutic radiopharmaceuticals with HCPCS codes, but which do not
have pass-through status and are without claims data, on the WACs for
these products if ASP data for these therapeutic radiopharmaceuticals
are not available. If the WACs are also unavailable, we proposed to
make payment for new therapeutic radiopharmaceuticals at 95 percent of
the products' most recent AWP because we would not have mean costs from
hospital claims data upon which to base payment. As we proposed with
new drugs and biologicals, we proposed to continue our policy of
assigning status indicator ``K'' to HCPCS codes for new therapeutic
radiopharmaceuticals without OPPS claims data for which we have not
granted pass-through status.
Consistent with other ASP-based payment, for CY 2013 we proposed to
announce any changes to the payment amounts for new drugs and
biologicals in this CY 2013 OPPS/ASC final rule with comment period and
also on a quarterly basis on the CMS Web site during CY 2013 if later
quarter ASP submissions (or more recent WACs or AWPs) indicate that
changes to the payment rates for these drugs and biologicals are
necessary. The payment
[[Page 68393]]
rates for new therapeutic radiopharmaceuticals would also be changed
accordingly based on later quarter ASP submissions. We note that the
new CY 2013 HCPCS codes for drugs, biologicals and therapeutic
radiopharmaceuticals were not available at the time of development of
the proposed rule. However, these agents are included in Addendum B to
this CY 2013 OPPS/ASC final rule with comment period (which is
available via the Internet on the CMS Web site), where they are
assigned comment indicator ``NI.'' This comment indicator reflects that
their interim final OPPS treatment is open to public comment in this CY
2013 OPPS/ASC final rule with comment period.
There are several nonpass-through drugs and biologicals that were
payable in CY 2011 and/or CY 2012 for which we did not have CY 2011
hospital claims data available for the proposed rule and for which
there are no other HCPCS codes that describe different doses of the
same drug, but which have pricing information available for the ASP
methodology. We note that there are currently no therapeutic
radiopharmaceuticals in this category. In order to determine the
packaging status of these products for CY 2013, we calculated an
estimate of the per day cost of each of these items by multiplying the
payment rate of each product based on ASP+6 percent, similar to other
nonpass-through drugs and biologicals paid separately under the OPPS,
by an estimated average number of units of each product that would
typically be furnished to a patient during one day in the hospital
outpatient setting. This rationale was first adopted in the CY 2006
OPPS/ASC final rule with comment period (70 FR 68666 and 68667).
We did not receive any public comments on our proposal to use
estimated per day costs for these drugs and biologicals or on the
resulting packaging status of these drugs and biologicals. Therefore,
for the reasons described in our proposed rule, we are finalizing our
CY 2013 proposal, with modification, to use the estimated number of
units per day included in Table 37 below to determine estimated per day
costs for the corresponding drugs and biologicals for CY 2013. For
those drugs and biologicals without CY 2011 claims data that we
determine to be separately payable in CY 2013, payment will be made at
ASP+6 percent. If ASP information is not available, payment will be
based on WAC, or 95 percent of the most recently published AWP if WAC
is not available.
The proposed estimated units per day and status indicators for
these items were displayed in Table 27 of the proposed rule (77 FR
45143).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45143), we proposed to
package items for which we estimated the per day administration cost to
be less than or equal to $80, which is the general packaging threshold
that we proposed for drugs, nonimplantable biologicals, and therapeutic
radiopharmaceuticals in CY 2013. We proposed to pay separately for
items with an estimated per day cost greater than $80 (with the
exception of diagnostic radiopharmaceuticals and contrast agents, which
we proposed to continue to package regardless of cost as discussed in
more detail in section II.A.3.d. of this final rule with comment
period) in CY 2013. We proposed that the CY 2013 payment for separately
payable items without CY 2011 claims data would be ASP+6 percent,
similar to payment for other separately payable nonpass-through drugs
and biologicals under the OPPS. In accordance with the ASP methodology
paid in the physician's office setting, in the absence of ASP data, we
proposed to use the WAC for the product to establish the initial
payment rate. However, we note that if the WAC is also unavailable, we
would make payment at 95 percent of the most recent AWP available.
Although we did not receive any specific public comments regarding
our proposed payment for nonpass-through drugs, biologicals, and
radiopharmaceuticals with HCPCS codes, but without OPPS hospital claims
data, many commenters supported our proposal to pay for separately
payable drugs at ASP+6 percent under the statutory default. However,
these comments were not specific to new drugs and biologicals with
HCPCS codes but without OPPS claims data. For more information
regarding payment for separately payable drugs, including general
public comments and our responses, we refer readers to section V.B.3.b.
of this final rule with comment period. In addition, commenters
responding to the CY 2013 OPPS/ASC proposed rule objected to packaging
payment for diagnostic radiopharmaceuticals and contrast agents in
general, but these comments were not directed to new diagnostic
radiopharmaceuticals or contrast agent with HCPCS codes but without
OPPS claims data. We summarize these comments and provide our response
in section II.A.3.e. of this final rule with comment period. We are
finalizing our CY 2013 proposal, without modification, as follows:
Payment for new drugs (excluding contrast agents and diagnostic
radiopharmaceuticals), nonimplantable biologicals, and therapeutic
radiopharmaceuticals with HCPCS codes that do not crosswalk to CY 2012
HCPCS codes, but which do not have pass-through status and for which we
do not have OPPS hospital claims data, will be made at ASP+6 percent
for CY 2013, consistent with the final CY 2013 payment methodology for
other new separately payable nonpass-through drugs, nonimplantable
biologicals and therapeutic radiopharmaceuticals, described in section
V.B.3.b. of this final rule with comment period. In cases where ASP
information is not available, payment will be made using WAC, and, if
WAC is also unavailable, payment will be made at 95 percent of the
product's most recent AWP. Further, payment for all new nonpass-through
diagnostic radiopharmaceuticals, contrast agents, and implantable
biologicals with HCPCS codes but for which we do not have OPPS claims
data will be packaged for CY 2013. Finally, we are assigning status
indicator ``K'' to HCPCS codes for new drugs and nonimplantable
biologicals for which we do not have OPPS claims data and for which we
have not granted pass-through status for CY 2012. With respect to new
items for which we do not have ASP data, once their ASP data become
available in later quarterly submissions, their payments will be
adjusted so that the rates will be based on the ASP methodology and set
to the finalized ASP amount of ASP+4 percent. This policy will ensure
that payment is made for actual acquisition cost and pharmacy overhead
for these new products.
For CY 2013, we also proposed to continue our CY 2012 policy to
base payment for new therapeutic radiopharmaceuticals with HCPCS codes,
but which do not have pass-through status and for which we do not have
claims data, on the WACs for these products if ASP data for these
therapeutic radiopharmaceuticals are not available. If the WACs are
also unavailable, we proposed to make payment for a new therapeutic
radiopharmaceutical at 95 percent of the product's most recent AWP
because we would not have mean costs from hospital claims data upon
which to base payment. Analogous to new drugs and biologicals, we
proposed to continue our policy of assigning status indicator ``K'' to
HCPCS codes for new therapeutic radiopharmaceuticals without OPPS
claims data for which we have not granted pass-through status.
We did not receive any public comments specific to our proposal for
[[Page 68394]]
new therapeutic radiopharmaceuticals with HCPCS codes but without pass-
through status. However, commenters responding to the CY 2013 OPPS/ASC
proposed rule were generally supportive of the ASP methodology for
payment for therapeutic radiopharmaceuticals in the HOPD, and we are
finalizing an ASP payment methodology for separately payable
therapeutic radiopharmaceuticals for CY 2013, as discussed in section
V.B.3.c. of this final rule with comment period.
We are finalizing our CY 2013 proposals, without modification, to
provide payment based on WAC for new therapeutic radiopharmaceuticals
with HCPCS codes but without pass-through status and for which we do
not have claims data, if ASP data for these therapeutic
radiopharmaceuticals are not available. If WAC information is also
unavailable, we will make payment for new therapeutic
radiopharmaceuticals at 95 percent of the product's most recent AWP. In
addition, we are assigning status indicator ``K'' to HCPCS codes for
new therapeutic radiopharmaceuticals without claims data in CY 2013
that do not have pass-through status.
Consistent with other ASP-based payments, for CY 2013, we proposed
to announce any changes to the payment amounts for new drugs and
biologicals in the CY 2013 OPPS/ASC final rule with comment period and
also on a quarterly basis on the CMS Web site during CY 2013 if later
quarter ASP submissions (or more recent WACs or AWPs) indicate that
changes to the payment rates for these drugs and biologicals are
necessary. The payment rates for new therapeutic radiopharmaceuticals
will also be changed accordingly, based on later quarter ASP
submissions. We note that the new CY 2013 HCPCS codes for drugs,
biologicals, and therapeutic radiopharmaceuticals were not available at
the time of development of the proposed rule. However, they are
included in Addendum B to this CY 2013 OPPS/ASC final rule with comment
period. They are assigned comment indicator ``NI'' in Addendum B to
reflect that their interim final OPPS treatment is open to public
comment on this CY 2013 OPPS/ASC final rule with comment period.
We did not receive any public comments on our proposal to announce,
via the CMS Web site, any changes to the OPPS payment amounts for new
drugs and biologicals on a quarterly basis. Therefore, for the reasons
described in the CY 2013 proposed rule, we are finalizing our proposal
and will update payment rates for new drugs, biologicals, and
therapeutic radiopharmaceuticals, as necessary, in association with our
quarterly update process and provide this information on the CMS Web
site.
BILLING CODE 4120-01-P
[[Page 68395]]
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Finally, there were 19 drugs and biologicals, shown in Table 28 of
the proposed rule (77 FR 45144), that were payable in CY 2011, but for
which we lacked CY 2011 claims data and any other pricing information
for the ASP methodology for the CY 2013 OPPS/ASC proposed rule. In CY
2009, for similar items without CY 2007 claims data and without pricing
information for the ASP methodology, we stated that we were unable to
determine their per day cost and we packaged these items for the year,
assigning these items status indicator ``N.''
For CY 2010, we finalized a policy to change the status indicator
for drugs and biologicals previously assigned a payable status
indicator to status indicator ``E'' (Not paid by Medicare when
submitted on outpatient claims (any outpatient bill type)) whenever we
lacked claims data and pricing information and were unable to determine
the per day cost. In addition, we noted that we would provide separate
payment for these drugs and biologicals if pricing information
reflecting recent sales became available mid-year in CY 2010 for the
ASP methodology. If pricing information became available, we would
assign the products status indicator ``K'' and pay for them separately
for the remainder of CY 2010. We continued this policy for CY 2011 and
CY 2012 (75 FR 71973 and 76 FR 74334).
For CY 2013, we proposed to continue to assign status indicator
``E'' to drugs and biologicals that lack CY 2011 claims data and
pricing information for the ASP methodology. All drugs and biologicals
without CY 2011 hospital claims data and data based on the ASP
methodology that are assigned status indicator ``E'' on this basis at
the time of the proposed rule for CY 2013 were displayed in Table 28 of
the proposed rule (77 FR 45144). If pricing information becomes
available, we proposed to assign the products status indicator ``K''
and pay for them separately for the remainder of CY 2013.
Comment: Several commenters disagreed with CMS' proposal to assign
a status indicator ``E'' to HCPCS code Q4102 (Talymed, per square
centimeter) for CY 2013. The commenters requested a status indicator of
``K'' to more closely align the product with others on the market, such
as the products represented by HCPCS code Q4101 and Q4102. The
commenters indicated that a status indicator of ``E'' would make it
impossible for the necessary claims data and pricing to be collected.
The manufacturers of the product that is described by HCPCS code
Q4101 assured CMS that they will be submitting ASP data shortly and
anticipate that CMS will replace the
[[Page 68396]]
status indicator ``E'' with the status indicator ``K'' upon submission
of this data.
Response: For this final rule with comment period, we have not
received ASP pricing information in order to assign a status indicator
of ``K'' to HCPCS code Q4101. Therefore, according to our longstanding
policy, we will continue to assign HCPCS code Q4101 to a status
indicator of ``E.'' If pricing information becomes available, we will
assign HCPCS code Q4101 a status indicator ``K'' and pay for it
separately for the remainder of CY 2013. We cannot assign a payable
status indicator to products that have no available payment
information.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period expressed concern that the assignment of
status indicator ``E'' to HCPCS code Q4128 was a technical error that
should have been changed to status indicator ``K'' effective January 1,
2012.
Response: For the CY 2012 OPPS/ASC final rule with comment period,
HCPCS code Q4128 (Flexhd or allopatch hd, per square centimeter) was
not erroneously assigned a status indicator of ``E'' because we did not
have ASP pricing information available to us at the time of the
publication of the final rule. However, during CY 2012, we received
pricing information for HCPCS code Q4128 and assigned status indicator
``K'' to this code. For CY 2013, this HCPCS code continues to have a
status indicator of ``K'' and the price is published in Addendum B of
this final rule with comment period.
After the proposed rule was published, we were able to use updated
CY 2011 claims data and ASP pricing information for HCPCS code J1452
(Injection, fomivirsen sodium, intraocular, 1.65 mg), HCPCS code J1835
(Injection, itraconazole, 50 mg), and HCPCS code J9212 (Injection,
interferon alfacon-1, recombinant, 1 microgram). Therefore, we are
assigning HCPCS code J1452, HCPCS code J1835, and HCPCS code J9212 a
status indicator of ``K'' for CY 2013. The revised status indicators
for these HCPCS codes are included in Addendum B to this CY 2013 OPPS/
ASC final rule with comment period (which is available via the Internet
on the CMS Web site).
Further, as we have used updated claims data and ASP pricing
information for this final rule with comment period, we have newly
identified HCPCS codes Q4134 (Hmatrix, per square centimeter), Q4135
(Mediskin, per square centimeter), and Q4136 (Ez-derm, per square
centimeter) as lacking CY 2011 claims data and any other pricing
information for the ASP methodology. Therefore, in addition to the
HCPCS codes for which we proposed to assign status indicator ``E'' for
CY 2013 due to a lack of claims data and any other pricing information
in the proposed rule, we are assigning status indicator ``E'' to HCPCS
codes Q4134, Q4135, and Q4136.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to assign status
indicator ``E'' to these drugs and biologicals. As was our policy in CY
2012, if pricing information becomes available for these products in CY
2013, we will assign the products status indicator ``K'' and pay for
them separately for the remainder of CY 2013.
All drugs and biologicals without CY 2011 hospital claims data and
data based on the ASP methodology that are assigned status indicator
``E'' on this basis at the time of this final rule with comment period
for CY 2013 are displayed in Table 37 below.
[[Page 68397]]
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VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
Section 1833(t)(6)(E) of the Act limits the total projected amount
of transitional pass-through payments for drugs, biologicals,
radiopharmaceuticals, and categories of devices for a given year to an
``applicable percentage,'' currently not to exceed 2.0 percent of total
program payments estimated to be made for all covered services under
the OPPS furnished for that year.
If we estimate before the beginning of the calendar year that the
total amount of pass-through payments in that year would exceed the
applicable percentage, section 1833(t)(6)(E)(iii) of the Act requires a
uniform prospective reduction in the amount of each of the transitional
pass-through payments made in that year to ensure that the limit is not
exceeded. We estimate the pass-through spending to determine whether
payments exceed the applicable percentage and the appropriate pro rata
reduction to the conversion factor for the projected level of pass-
through spending in the following year to ensure that total estimated
pass-through spending for the prospective payment year is budget
neutral, as required by section 1833(t)(6)(E) of the Act.
For devices, developing an estimate of pass-through spending in CY
2013 entails estimating spending for two groups of items. The first
group of items consists of device categories that were recently made
eligible for pass-through payment and that will continue to be eligible
for pass-through payment in CY 2013. The CY 2008 OPPS/ASC final rule
with comment period (72 FR 66778) describes the methodology we have
used in previous years to develop the pass-through spending estimate
for known device categories continuing into the applicable update year.
The second group of items consists of items that we know are newly
eligible, or project may be newly eligible, for device pass-through
payment in the remaining quarters of CY 2012 or beginning in CY 2013.
The sum of the CY 2013 pass-through estimates for these two groups of
device categories equals the total CY 2013 pass-through spending
estimate for device categories with pass-through status. We base the
device pass-through estimated payments for each device category on the
amount of payment as established in section 1833(t)(6)(D)(ii) of the
Act, and as outlined in previous rules, including the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74335 through 74336). We note
that, beginning in CY 2010, the pass-through evaluation process and
pass-through payment for implantable biologicals newly approved for
pass-through payment beginning on or after January 1, 2010, that are
surgically inserted or implanted (through a surgical incision or a
natural orifice), is the device pass-through process and payment
methodology (74 FR 60476). As has been our past practice (76 FR 74335),
we
[[Page 68398]]
include an estimate of any implantable biologicals eligible for pass-
through payment in our estimate of pass-through spending for devices.
For drugs and nonimplantable biologicals eligible for pass-through
payment, section 1833(t)(6)(D)(i) of the Act establishes the pass-
through payment amount as the amount by which the amount authorized
under section 1842(o) of the Act (or, if the drug or biological is
covered under a competitive acquisition contract under section 1847B of
the Act, an amount determined by the Secretary equal to the average
price for the drug or biological for all competitive acquisition areas
and year established under such section as calculated and adjusted by
the Secretary) exceeds the portion of the otherwise applicable fee
schedule amount that the Secretary determines is associated with the
drug or biological. We note that the Part B drug CAP program has been
postponed since CY 2009, and such a program was not proposed to be
reinstated for CY 2013. Because we will pay for most nonpass-through
separately payable drugs and nonimplantable biologicals under the CY
2013 OPPS at ASP+6 percent, as we discussed in section V.B.3. of this
final rule with comment period, which represents the otherwise
applicable fee schedule amount associated with most pass-through drugs
and nonimplantable biologicals, and because we will pay for CY 2013
pass-through drugs and nonimplantable biologicals at ASP+6 percent, as
we discussed in section V.A. of this final rule with comment period,
our estimate of drug and nonimplantable biological pass-through payment
for CY 2013 for this group of items is zero, as discussed below.
Furthermore, payment for certain drugs, specifically diagnostic
radiopharmaceuticals and contrast agents, without pass-through status,
will always be packaged into payment for the associated procedures
because these products will never be separately paid. However, all
pass-through diagnostic radiopharmaceuticals and contrast agents with
pass-through status approved prior to CY 2013 will be paid at ASP+6
percent like other pass-through drugs and nonimplantable biologicals.
Therefore, our estimate of pass-through payment for all diagnostic
radiopharmaceuticals and contrast agents with pass-through status
approved prior to CY 2013 is not zero. In section V.A.4. of this final
rule with comment period, we discuss our policy to determine if the
cost of certain ``policy-packaged'' drugs, including diagnostic
radiopharmaceuticals and contrast agents, are already packaged into the
existing APC structure. If we determine that a ``policy-packaged'' drug
approved for pass-through payment resembles predecessor diagnostic
radiopharmaceuticals or contrast agents already included in the costs
of the APCs that are associated with the drug receiving pass-through
payment, we are offsetting the amount of pass-through payment for
diagnostic radiopharmaceuticals or contrast agents. For these drugs,
the APC offset amount is the portion of the APC payment for the
specific procedure performed with the pass-through radiopharmaceuticals
or contrast agents, which we refer to as the ``policy-packaged'' drug
APC offset amount. If we determine that an offset is appropriate for a
specific diagnostic radiopharmaceutical or contrast agent receiving
pass-through payment, we reduce our estimate of pass-through payment
for these drugs by this amount.
Similar to pass-through estimates for devices, the first group of
drugs and nonimplantable biologicals requiring a pass-through payment
estimate consists of those products that were recently made eligible
for pass-through payment for CY 2012 and that will continue to be
eligible for pass-through payment in CY 2013. The second group contains
drugs and nonimplantable biologicals that we know are newly eligible,
or project will be newly eligible, in the remaining quarters of CY 2012
or beginning in CY 2013. The sum of the CY 2013 pass-through estimates
for these two groups of drugs and nonimplantable biologicals equals the
total CY 2013 pass-through spending estimate for drugs and
nonimplantable biologicals with pass-through status.
B. Estimate of Pass-Through Spending
In the CY 2013 OPPS/ASC proposed rule (77 FR 45145), we proposed to
set the applicable pass-through payment percentage limit at 2.0 percent
of the total projected OPPS payments for CY 2013, consistent with
section 1833(t)(6)(E)(ii)(II) of the Act, and our OPPS policy from CY
2004 through CY 2012 (76 FR 74336).
For the first group of devices for pass-through payment estimation
purposes, there currently are three device categories eligible for
pass-through payment for CY 2013: C1830 (Powered bone marrow biopsy
needle); C1840 (Lens, intraocular (telescopic)); and C1886 (Catheter,
extravascular tissue ablation, any modality (insertable). In the
proposed rule, we estimated that CY 2013 pass-through expenditures
related to these three eligible device categories would be
approximately $42 million. In estimating our CY 2013 pass-through
spending for device categories in the second group, we include: Device
categories that we knew at the time of the development of the proposed
rule will be newly eligible for pass-through payment in CY 2013 (of
which there are none); additional device categories that we estimate
could be approved for pass-through status subsequent to the development
of the proposed rule and before January 1, 2013; and contingent
projections for new device categories established in the second through
fourth quarters of CY 2013. We proposed to use the general methodology
described in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66778), while also taking into account recent OPPS experience in
approving new pass-through device categories. For the proposed rule,
the estimate of CY 2013 pass-through spending for this second group of
device categories was $10 million. Using our established methodology,
we proposed that the total estimated pass-through spending for device
categories for CY 2013 (spending for the first group of device
categories ($42 million) plus spending for the second group of device
categories ($10 million)) would be $52 million.
We did not receive any public comments regarding our proposed pass-
through spending estimate for devices. Therefore, for CY 2013, we are
continuing to use our established methodology for estimating pass-
through spending for device categories. For this final rule with
comment period, using our established methodology and updated data and
information, we estimate CY 2013 pass-through spending for the first
group of device categories to be $42, and the CY 2013 pass-through
spending for the second group of device categories to be $10 million.
The total estimated pass-through spending for device categories for CY
2013 (spending for the first group of device categories ($42 million)
plus spending for the second group of device categories ($10 million))
is $52 million.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45146), to estimate CY
2013 pass-through spending for drugs and nonimplantable biologicals in
the first group, specifically those drugs (including
radiopharmaceuticals and contrast agents) and nonimplantable
biologicals recently made eligible for pass-through payment and
continuing on pass-through status for CY 2013, we proposed to utilize
the most recent Medicare physician's office data regarding their
utilization, information provided in the respective pass-through
applications, historical hospital claims data, pharmaceutical industry
information, and clinical information
[[Page 68399]]
regarding those drugs or nonimplantable biologicals, to project the CY
2013 OPPS utilization of the products.
For the known drugs and nonimplantable biologicals (excluding
diagnostic radiopharmaceuticals and contrast agents) that will be
continuing on pass-through status in CY 2013, in the proposed rule (77
FR 45145), we estimated the pass-through payment amount as the
difference between ASP+6 percent and the payment rate for nonpass-
through drugs and nonimplantable biologicals that will be separately
paid at ASP+6 percent, which is zero for this group of drugs. Because
payment for a diagnostic radiopharmaceutical or contrast agent is
packaged if the product was not paid separately due to its pass-through
status, we proposed to include in the CY 2013 pass-through estimate the
difference between payment for the drug or biological at ASP+6 percent
(or WAC+6 percent, or 95 percent of AWP, if ASP or WAC information is
not available) and the ``policy-packaged'' drug APC offset amount, if
we determined that the diagnostic radiopharmaceutical or contrast agent
approved for pass-through payment resembles predecessor diagnostic
radiopharmaceuticals or contrast agents already included in the costs
of the APCs that are associated with the drug receiving pass-through
payment. In the proposed rule, using the proposed methodology described
above, we calculated a CY 2013 proposed spending estimate for this
first group of drugs and nonimplantable biologicals of approximately
$13 million.
We did not receive any public comments on our proposed methodology
for calculating the spending estimate for the first group of drugs and
nonimplantable biologicals. Therefore, for this final rule with comment
period, we are finalizing our proposed methodology. Using our
established methodology and updated data and information, we calculated
a final CY 2013 spending estimate for the first group of drugs and
nonimplantable biologicals of approximately $15 million.
In the proposed rule (77 FR 45146), to estimate CY 2013 pass-
through spending for drugs and nonimplantable biologicals in the second
group (that is, drugs and nonimplantable biologicals that we knew at
the time of development of the proposed rule are newly eligible for
pass-through payment in CY 2013, additional drugs and nonimplantable
biologicals that we estimate could be approved for pass-through status
subsequent to the development of the proposed rule and before January
1, 2013, and projections for new drugs and nonimplantable biologicals
that could be initially eligible for pass-through payment in the second
through fourth quarters of CY 2013), we proposed to use utilization
estimates from pass-through applicants, pharmaceutical industry data,
clinical information, recent trends in the per unit ASPs of hospital
outpatient drugs, and projected annual changes in service volume and
intensity as our basis for making the CY 2013 pass-through payment
estimate. We also proposed to consider the most recent OPPS experience
in approving new pass-through drugs and nonimplantable biologicals.
Using our proposed methodology for estimating CY 2013 pass-through
payments for this second group of drugs, we calculated a proposed
spending estimate for this second group of drugs and nonimplantable
biologicals of approximately $19 million.
We did not receive any public comments on our proposed methodology
for estimating CY 2013 pass-through payments for this second group of
drugs and nonimplantable biologicals. Therefore, for this final rule
with comment period, are finalizing our proposed methodology. Using
that methodology and updated data and information, we calculated a
final CY 2013 spending estimate for this second group of drugs and
implantable biologicals of approximately $7 million.
As discussed in section V.A. of this final rule with comment
period, radiopharmaceuticals are considered drugs for pass-through
purposes. Therefore, we include radiopharmaceuticals in our CY 2013
pass-through spending estimate for drugs and nonimplantable
biologicals. Our CY 2013 estimate for total pass-through spending for
drugs and nonimplantable biologicals (spending for the first group of
drugs and nonimplantable biologicals ($15 million) plus spending for
the second group of drugs and nonimplantable biologicals ($7 million))
equals $22 million.
In summary, in accordance with the methodology described above in
this section, for this final rule with comment period, we estimate that
total pass-through spending for the device categories and the drugs and
nonimplantable biologicals that are continuing to receive pass-through
payment in CY 2013 and those device categories, drugs, and biologicals
that first become eligible for pass-through payment during CY 2013 will
be approximately $74 million (approximately $52 million for device
categories and approximately $22 million for drugs and nonimplantable
biologicals), which represents 0.15 percent of total projected OPPS
payments for CY 2013. We estimate that pass-through spending in CY 2013
will not amount to 2.0 percent of total projected OPPS CY 2013 program
spending.
VII. OPPS Payment for Hospital Outpatient Visits
A. Background
Currently, hospitals report HCPCS visit codes to describe three
types of OPPS services: Clinic visits, emergency department visits, and
critical care services, including trauma team activation. As we
proposed in the CY 2013 OPPS/ASC proposed rule (77 FR 45146 through
45148), for CY 2013, we are continuing to recognize these CPT and HCPCS
codes describing clinic visits, Type A and Type B emergency department
visits, and critical care services, which are listed below in Table 38,
for CY 2013. We refer readers to the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74338 through 74346) for a full discussion of our
longstanding policy on OPPS payment for hospital outpatient visits.
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At its August 27-28, 2012 meeting, the HOP Panel recommended that
CMS move HCPCS code G0379 (Direct admission of patient for hospital
observation care) to APC 0608 (Level 5 Hospital Clinic Visits). We are
accepting this recommendation, as discussed below in this section.
B. Policies for Hospital Outpatient Visits
We proposed in the CY 2013 OPPS/ASC proposed rule (77 FR 45147
through 45148), for CY 2013, to continue our longstanding policies
related to hospital outpatient visits, which includes clinic visits,
emergency department visits, and critical care services. Specifically,
we proposed to continue to recognize the definitions of a new patient
and an established patient, which are based on whether the patient has
been registered as an inpatient or outpatient of the hospital within
the 3 years prior to a visit. We also proposed to continue to apply our
policy of calculating costs for clinic visits under the OPPS using
historical hospital claims data through five levels of clinic visit
APCs (APCs 0604 through 0608). In addition, we proposed to continue to
recognize Type A emergency departments and Type B emergency departments
for payment purposes under the OPPS, and to pay for Type A emergency
department visits based on their costs through the five levels of Type
A emergency department APCs (APCs 0609 and 0613 through 0616) and to
pay for Type B emergency department visits based on their costs through
the five levels of Type B emergency department APCs (APCs 0626 through
0630). We refer readers to Addendum B to this final rule with comment
period (which is available via the Internet on the CMS Web site) for
the APC assignments and payment rates for these hospital outpatient
visits. Finally, we proposed to continue to instruct hospitals to
report facility resources for clinic and emergency department hospital
outpatient visits using the CPT E/M codes and to develop internal
hospital guidelines for reporting the appropriate visit level. We note
that our continued expectation is that hospitals' internal guidelines
will comport with the principles listed in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66805). We encourage hospitals with
specific questions related to the creation of internal guidelines to
contact their servicing fiscal intermediary or MAC. We refer readers to
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74338
through 74346) for a full historical discussion of these longstanding
policies. We note recent reports in the public media of billing
inaccuracies in hospital outpatient clinic visits, and remind hospitals
that we are committed to vigorously enforcing our payment policies and
will pursue appropriate action against any potentially fraudulent
activities we identify.
We also proposed to continue the methodology established in the CY
2011 OPPS/ASC final rule with comment period for calculating a payment
rate for critical care services that includes packaged payment of
ancillary services. For CY 2010 and in prior years, the AMA CPT
Editorial Panel defined critical care CPT codes 99291 (Critical care,
evaluation and management of the critically ill or critically injured
patient; first 30-74 minutes) and 99292 (Critical care, evaluation and
management of the critically ill or critically injured patient; each
additional 30 minutes (List separately in addition to code for primary
service)) to include a wide range of ancillary services such as
electrocardiograms, chest X-rays and pulse oximetry. As we have stated
in manual instruction, we expect hospitals to report in accordance with
CPT guidance unless we instruct otherwise. For critical care in
particular, we instructed hospitals that any services that the CPT
Editorial Panel indicates are included in the reporting of CPT code
99291 (including those services that would otherwise be reported by and
paid to hospitals using any of the CPT codes specified by the CPT
Editorial Panel) should not be billed separately. Instead, hospitals
were instructed to report charges for any services provided as part of
the critical care services. In establishing payment rates for critical
care services, and other services, CMS packages the costs of certain
items and services separately reported by HCPCS codes into payment for
critical care services and other services, according to the standard
OPPS methodology for packaging costs (Medicare Claims Processing
Manual, Pub. 100-04, Chapter 4, Section 160.1).
For CY 2011, the AMA CPT Editorial Panel revised its guidance for
the critical care codes to specifically state that, for hospital
reporting purposes, critical care codes do not include the specified
ancillary services. Beginning in CY 2011, hospitals that report in
accordance with the CPT guidelines should report all of the ancillary
[[Page 68402]]
services and their associated charges separately when they are provided
in conjunction with critical care. Because the CY 2011 payment rate for
critical care services was based on hospital claims data from CY 2009,
during which time hospitals would have reported charges for any
ancillary services provided as part of the critical care services, we
stated in the CY 2011 OPPS/ASC final rule with comment period that we
believed it was inappropriate to pay separately in CY 2011 for the
ancillary services that hospitals may now report in addition to
critical care services (75 FR 71988). Therefore, for CY 2011, we
continued to recognize the existing CPT codes for critical care
services and established a payment rate based on historical data, into
which the cost of the ancillary services was intrinsically packaged. We
also implemented claims processing edits that conditionally package
payment for the ancillary services that are reported on the same date
of service as critical care services in order to avoid overpayment. We
noted in the CY 2011 OPPS/ASC final rule with comment period that the
payment status of the ancillary services would not change when they are
not provided in conjunction with critical care services. We assigned
status indicator ``Q3'' (Codes That May Be Paid Through a Composite
APC) to the ancillary services to indicate that payment for these
services is packaged into a single payment for specific combinations of
services and made through a separate APC payment or packaged in all
other circumstances, in accordance with the OPPS payment status
indicated for status indicator ``Q3'' in Addendum D1 to the CY 2011
OPPS/ASC final rule with comment period. The ancillary services that
were included in the definition of critical care prior to CY 2011 and
that are conditionally packaged into the payment for critical care
services when provided on the same date of service as critical care
services for CY 2011 were listed in Addendum M to that final rule with
comment period.
Because the CY 2012 costs for critical care services were based
upon CY 2010 claims data, which reflect the CPT billing guidance that
was in effect prior to CY 2011, in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74343 through 74344), we continued the
methodology established in the CY 2011 OPPS/ASC final rule with comment
period of calculating a payment rate for critical care services based
on our historical claims data, into which the cost of the ancillary
services is intrinsically packaged for CY 2012. We also continued to
implement claims processing edits that conditionally package payment
for the ancillary services that are reported on the same date of
service as critical care services in order to avoid overpayment.
As we discussed in the CY 2013 OPPS/ASC proposed rule (77 FR
45148), the CY 2011 hospital claims data on which the CY 2013 payment
rates are based reflect the first year of claims billed under the
revised CPT guidance to allow the reporting of all the ancillary
services and their associated charges separately when they are provided
in conjunction with critical care. Because our policy to establish
relative payment weights based on geometric mean cost data for CY 2013
represents a change from our historical practice to base payment rates
on median costs, and because we now have hospital claims data for the
first time reflecting the revised coding guidance for critical care, we
reviewed the CY 2011 hospital claims data available for the proposed
rule and determined that the data show increases in both the mean and
median line item costs as well as the mean and median line item charges
for CPT code 99291, when compared to CY 2010 hospital claims data.
Specifically, the mean and median line item costs increased 13 percent
and 16 percent, respectively, and the mean and median line item charges
increased 11 percent and 14 percent, respectively. Additionally, when
compared to CY 2010 hospital claims data, CY 2011 hospital claims data
showed no substantial change in the ancillary services that are present
on the same claims as critical care services, and also showed continued
low volumes of many ancillary services. We stated in the proposed rule
that, had the majority of hospitals changed their billing practices to
separately report and charge for the ancillary services formerly
included in the definition of critical care CPT codes 99291 and 99292,
we would have expected to see a decrease in the costs and charges for
these CPT codes, and a significant increase in ancillary services
reported on the same claims. We indicated that the lack of a
substantial change in the services reported on critical care claims,
along with the increases in the line item costs and charges for
critical care services, strongly suggests that many hospitals did not
change their billing practices for CPT code 99291 following the
revision to the CPT coding guidance effective January 1, 2011.
In light of not having claims data to support a significant change
in hospital billing practices, we stated in the proposed rule that we
continue to believe that it is inappropriate to pay separately in CY
2013 for the ancillary services that hospitals may now report in
addition to critical care services. Therefore, for CY 2013, we
proposed, to continue our CY 2011 and CY 2012 policy to recognize the
existing CPT codes for critical care services and establish a payment
rate based on historical claims data. We also proposed to continue to
implement claims processing edits that conditionally package payment
for the ancillary services that are reported on the same date of
service as critical care services in order to avoid overpayment. We
stated that we will continue to monitor the hospital claims data for
CPT code 99291 in order to determine whether revisions to this policy
are warranted based on changes in hospitals' billing practices.
Comment: One commenter indicated that because hospitals have used
internal, hospital-defined guidelines for over 10 years, CMS should not
move to standard national guidelines. In the absence of national
guidelines for visit reporting, some commenters urged CMS to support a
request to the AMA's CPT Editorial Panel to create unique CPT codes for
hospital reporting of emergency department and clinic visits.
Response: We agree with the commenter that we should not move to
national guidelines for visits in CY 2013. As we have in the past (76
FR 74345 through 74346), we acknowledge that it would be desirable to
many hospitals to have national guidelines. However, we also understand
that it would be disruptive and administratively burdensome to other
hospitals that have successfully adopted internal guidelines to
implement any new set of national guidelines while we address the
problems that would be inevitable in the case of any new set of
guidelines that would be applied by thousands of hospitals. As we have
also stated in the past (76 FR 74346), if the AMA were to create
facility-specific CPT codes for reporting visits provided in HOPDs
[based on internally developed guidelines], we would consider such
codes for OPPS use.
Comment: One commenter recommended that CMS reassign HCPCS code
G0379 to APC 0608 (Level 5 Hospital Clinic Visits) because of the
consistent 2 times rule violation in APC 0604 (Level 1 Hospital Clinic
Visits) and HCPCS code G0379's similarity in both mean cost and
clinical characteristics to CPT code 99205 (Office or other outpatient
visit for the evaluation and management of a new patient (Level 5)).
The commenter pointed out that the
[[Page 68403]]
mean cost for HCPCS code G0379 is more similar to the mean cost for APC
0608 than it is to the mean cost for APC 0604. The commenter argued
that the resources associated with HCPCS code G0379 resemble those
expended for high-level clinic visits more than resources for low-level
clinic visits, and noted that CMS' claims logic for composite APC 8002
(Level I Extended Assessment and Management) treats HCPCS code G0379
similarly to high-level clinic visit CPT codes 99205 and 99215 (Office
or other outpatient visit for the evaluation and management of an
established patient (Level 5)).
Response: We agree with the rationale set forth by the commenter
and with the Panel, which recommended CMS reassign HCPCS code G0379
from APC 0604 to APC 0608. Therefore, we are reassigning HCPCS code
G0379 to APC 0608 for CY 2013.
Comment: Commenters recommended that CMS, in setting the payment
rate for critical care services by estimating the costs of the packaged
ancillary services, establish a methodology that includes review of
multiple cost report revenue centers.
Response: The methodology the commenters recommended is consistent
with the methodology we already have in place. As discussed in section
II.A.1.c. of this final rule with comment period, we calculate
hospital-specific overall ancillary CCRs and hospital-specific
departmental CCRs for each hospital for which we have claims data. We
apply the hospital-specific CCR to the hospital's charges at the most
detailed level possible, based on a revenue code-to-cost center
crosswalk that contains a hierarchy of CCRs used to estimate costs from
charges for each revenue code. Therefore, we base our cost estimation
of each packaged ancillary service on the most specific cost center to
which the revenue code reported with that service maps. We then package
the cost that we estimate as a result of that process into the mean
cost calculation for critical care.
Comment: One commenter argued that the ancillary services
associated with critical care do not meet CMS' criteria for packaging.
The commenter suggested that, rather than packaging the ancillary
services associated with critical care, CMS use CY 2008 cost data for
CPT code 99291 updated with an overall inflation factor to recalculate
the cost of critical care exclusive of bundled ancillary services.
Response: As we discussed above in this section and in the CY 2013
OPPS/ASC proposed rule (76 45147 through 45148), the policy to package
ancillary services associated with critical care was implemented in CY
2011 and resulted from a change in CPT guidance effective January 1,
2011. We packaged the ancillary services because the costs of those
ancillary services were already intrinsically included in the cost
calculated for critical care; to pay for the ancillary services
separately result in overpayment. Because the claims data for critical
care for CY 2011 do not reflect that hospitals have changed their
billing practices in response to the revised CPT guidance effective
January 1, 2011--that is, they have not adjusted their charging
practices to reflect that the ancillary services are no longer included
in the definition of critical care--we continue to believe that the
costs of the ancillary services continue to be reflected in the
hospitals' charges for critical care, and that to pay separately for
the ancillary services would be inappropriate. We also do not agree
with the commenter that we should use claims data from CY 2008 to
calculate costs for critical care. We remind the commenter that the
OPPS is a system of averages, in which the costs of services,
calculated from the most recent year's claims data, are weighted
relative to the other services in the system, for that given year. To
utilize a payment rate derived from claims outside of the most recent
claims data, despite any update by the overall inflation factor, would
be inconsistent with the standard methodology of the OPPS, and would
not allow for that service to be appropriately valued relative to the
other services in the OPPS.
After consideration of the public comments we received, we are
finalizing our CY 2013 proposals related hospital outpatient visits,
with one modification. As described above, we are reassigning HCPCS
code G0379 to APC 0608 for CY 2013.
C. Transitional Care Management
In the CY 2013 MPFS proposed rule (77 FR 44774 through 44780), we
discussed a multiple year strategy exploring the best means to
encourage the provision of primary care and care coordination services
to Medicare beneficiaries. As part of the strategy discussed in that
proposed rule, we proposed to address the non-face-to-face work
involved in hospital or SNF discharge care coordination by creating a
HCPCS G-code for care management involving the transition of a
beneficiary from care furnished by a treating physician during a
hospital stay (inpatient, outpatient observation services, or
outpatient partial hospitalization), SNF stay, or CMHC partial
hospitalization program to care furnished by the beneficiary's
physician or qualified nonphysician practitioner in the community. As
discussed in the CY 2013 MPFS proposed rule, care management involving
the transition of a beneficiary from care furnished by a treating
physician during a hospital or a SNF stay to the beneficiary's primary
physician or qualified nonphysician practitioner in the community could
avoid adverse events such as readmissions or subsequent illnesses,
improve beneficiary outcomes, and avoid a financial burden on the
health care system. Successful efforts to improve hospital discharge
care coordination and care transitions could improve the quality of
care while simultaneously decreasing costs.
The proposed HCPCS G-code included in the CY 2013 MPFS proposed
rule, GXXX1, specifically describes post-discharge transitional care
management services, which include all non-face-to-face services
related to the transitional care management, furnished by the community
physician or nonphysician practitioner within 30 calendar days
following the date of discharge from an inpatient acute care hospital,
psychiatric hospital, LTCH, SNF, and IRF; discharge from hospital
outpatient observation or partial hospitalization services; or
discharge from a PHP at a CMHC, to the community-based care. The post-
discharge transitional care management services include non-face-to-
face care management services provided by clinical staff member(s) or
office-based case manager(s) under the supervision of the community
physician or qualified nonphysician practitioner.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45148 through 45159),
we stated that while we do not pay for physician or nonpractitioner
professional services under the OPPS (42 CFR 419.22), we recognize that
certain elements of the transitional care coordination services
described by proposed HCPCS code GXXX1 could be provided to a hospital
outpatient as an ancillary or supportive service in conjunction with a
primary diagnostic or therapeutic service that would be payable under
the OPPS, such as a clinic visit. We stated that, as described in
section II.A.3. of the proposed rule, we package payment for services
that are typically ancillary and supportive to a primary service. While
we do not make separate payment for such services, their costs are
included in the costs of other services furnished by the hospital to
the beneficiary on the same day. We indicated in the CY 2013 OPPS/ASC
proposed rule that, because transitional care management services
[[Page 68404]]
described by HCPCS code GXXX1 may be ancillary and supportive to a
primary service provided to a hospital outpatient, we proposed to
assign HCPCS code GXXX1 a status indicator of ``N'' (Items and Services
Packaged into APC Rates), signifying that its payment would be packaged
(77 FR 45159).
Comment: The majority of commenters supported the proposed
development of a HCPCS G-code to identify the non-face-to-face work
involved in hospital or SNF discharge care coordination. Some
commenters supported establishing a HCPCS G-code as a short-term
solution to capture the non-face-to-face services, but suggested that
in the long term, CMS consider generating new CPT codes specific to the
post-discharge transitional care management that would also capture
face-to-face components of transitional care. Some commenters also
stated that the requirements for billing the post-discharge
transitional care services (regardless of whether they are identified
with the new HCPCS G-code or a CPT code) should not be arduous or
complex. A few commenters expressed concern that the proposed HCPCS G-
code for transitional care management would be duplicative of discharge
day management services described by other CPT codes. Some commenters
requested that CMS establish a separate APC for the proposed HCPCS G-
code with a status indicator of ``S'' or ``X'' for transitional care
management services or assign the HCPCS G-code to APC 0605 (Level 2
Hospital Clinic Visits).
Response: For the reasons outlined in the CY 2013 MPFS final rule
with comment period, we are adopting the following CPT transitional
care management codes in place of the proposed HCPCS G-code: CPT code
99495 (Transitional care management services w/moderate medical
decision complexity; Face to face visit within 14 days) and CPT code
99496 (Transitional care management services w/high medical decision
complexity; Face to face visit within 7 days). We agree with the
commenters that the requirements for billing the post-discharge
transitional care management services should not be arduous or complex,
and we refer readers to the CY 2013 MPFS final rule with comment period
for a full discussion of the billing requirements for CPT codes 99495
and 99496. We also refer readers to the CY 2013 MPFS final rule with
comment period for a full discussion of why we do not believe that
recognition of the transitional care management services described by
CPT codes 99495 and 99496 is duplicative of services described by other
CPT codes.
The CPT transitional care management code 99495 includes the
following required elements:
Communication (direct contact, telephone, electronic) with
the patient and/or caregiver within 2 business days of discharge;
Medical decision-making of at least moderate complexity
during the service period; and
Face-to-face visit, within 14 calendar days of discharge.
CPT code 99496 includes the following required elements:
Communication (direct contact, telephone, electronic) with
the patient and/or caregiver within 2 business days of discharge;
Medical decision-making of high complexity during the
service period; and
Face-to-face visit, within 7 calendar days of discharge.
As we describe in the CY 2013 MPFS final rule with comment period,
the services described by CPT codes 99495 and 99496 are for an
established patient whose medical and/or psychosocial problems require
moderate or high complexity medical decision-making during transitions
in care from an inpatient hospital setting (including acute hospital,
rehabilitation hospital, long-term acute care hospital), partial
hospital, observation status in a hospital, or SNF/nursing facility, to
the patient's community setting (home, domiciliary, rest home, or
assisted living). Transitional care management commences upon the date
of discharge and continues for the next 29 days.
Transitional care management is comprised of one face-to-face visit
within the specified timeframes, in combination with non-face-to-face
services that may be performed by the physician or other qualified
health care professional and/or licensed clinical staff under his or
her direction. Because the transitional care management services
described by CPT codes 99495 and 99496 involve at least one face-to-
face visit, (unlike the proposed HCPCS G-code), we believe that CPT
codes 99495 and 99496 represent a primary, independent service that
should be separately payable under the OPPS. We are assigning CPT code
99495 to APC 0605 (Level 2 Hospital Clinic Visit) and CPT code 99496 to
APC 0606 (Level 3 Hospital Clinic Visit) on an interim basis for CY
2013. As with all new CPT codes, these interim assignments are open to
public comment for a period of 60 days following the publication of
this final rule with comment period.
As we discuss in the CY 2013 MPFS final rule with comment period,
we are adopting these new transitional care management codes to provide
a separate reporting mechanism to the community physician for these
services in the context of the broader CMS multi-year strategy to
recognize and support primary care and care management. We wish to
emphasize again that the policies we are finalizing in this final rule
with comment period may be short-term payment strategies that may be
modified and/or revised over time to be consistent with broader primary
care and care management initiatives. We refer readers to the CY 2013
MPFS final rule with comment period for a full discussion of post-
discharge transitional care management services in particular and, more
broadly, the multiple year strategy exploring the best means to
encourage primary care and care coordination services.
VIII. Payment for Partial Hospitalization Services
A. Background
Partial hospitalization is an intensive outpatient program of
psychiatric services provided to patients as an alternative to
inpatient psychiatric care for individuals who have an acute mental
illness. Section 1861(ff)(1) of the Act defines partial hospitalization
services as ``the items and services described in paragraph (2)
prescribed by a physician and provided under a program described in
paragraph (3) under the supervision of a physician pursuant to an
individualized, written plan of treatment established and periodically
reviewed by a physician (in consultation with appropriate staff
participating in such program), which plan sets forth the physician's
diagnosis, the type, amount, frequency, and duration of the items and
services provided under the plan, and the goals for treatment under the
plan.'' Section 1861(ff)(2) of the Act describes the items and services
included in partial hospitalization services. Section 1861(ff)(3)(A) of
the Act specifies that a partial hospitalization program (PHP) is a
program furnished by a hospital to its outpatients or by a community
mental health center (CMHC) (as defined in subparagraph (B)), and
``which is a distinct and organized intensive ambulatory treatment
service offering less than 24-hour-daily care other than in an
individual's home or in an inpatient or residential setting.'' Section
1861(ff)(3)(B) of the Act defines community mental health center.
Section 1833(t)(1)(B)(i) of the Act provides the Secretary with the
[[Page 68405]]
authority to designate the OPD services to be covered under the OPPS.
The Medicare regulations that implement this provision specify, at 42
CFR 419.21, that payments under the OPPS will be made for partial
hospitalization services furnished by CMHCs as well as Medicare Part B
services furnished to hospital outpatients designated by the Secretary,
which include partial hospitalization services (65 FR 18444 through
18445).
Section 1833(t)(2)(C) of the Act, in pertinent part, requires the
Secretary to ``establish relative payment weights for covered OPD
services (and any groups of such services described in subparagraph
(B)) based on median (or, at the election of the Secretary, mean)
hospital costs'' using data on claims from 1996 and data from the most
recent available cost reports. In pertinent part, subparagraph (B)
provides that the Secretary may establish groups of covered OPD
services, within a classification system developed by the Secretary for
covered OPD services, so that services classified within each group are
comparable clinically and with respect to the use of resources. In
accordance with these provisions, we have developed the APCs. Section
1833(t)(9)(A) of the Act requires the Secretary to ``review not less
often than annually and revise the groups, the relative payment
weights, and the wage and other adjustments described in paragraph (2)
to take into account changes in medical practice, changes in
technology, the addition of new services, new cost data, and other
relevant information and factors.''
Because a day of care is the unit that defines the structure and
scheduling of partial hospitalization services, we established a per
diem payment methodology for the PHP APCs, effective for services
furnished on or after July 1, 2000 (65 FR 18452 through 18455). Under
this methodology, the median per diem costs have been used to calculate
the relative payment weights for PHP APCs.
From CY 2003 through CY 2006, the median per diem costs for CMHCs
fluctuated significantly from year to year, while the median per diem
costs for hospital-based PHPs remained relatively constant. We were
concerned that CMHCs may have increased and decreased their charges in
response to Medicare payment policies. Therefore, we began efforts to
strengthen the PHP benefit through extensive data analysis and policy
and payment changes in the CY 2008 update (72 FR 66670 through 66676).
We made two refinements to the methodology for computing the PHP
median: the first remapped 10 revenue codes that are common among
hospital-based PHP claims to the most appropriate cost centers; and the
second refined our methodology for computing the PHP median per diem
cost by computing a separate per diem cost for each day rather than for
each bill. We refer readers to a complete discussion of these
refinements in the CY 2008 OPPS/ASC final rule with comment period (72
FR 66670 through 66676).
In CY 2009, we implemented several regulatory, policy, and payment
changes, including a two-tiered payment approach for PHP services under
which we paid one amount for days with 3 services (APC 0172 (Level I
Partial Hospitalization)) and a higher amount for days with 4 or more
services (APC 0173 (Level II Partial Hospitalization)). We refer
readers to section X.B. of the CY 2009 OPPS/ASC final rule with comment
period (73 FR 68688 through 68693) for a full discussion of the two-
tiered payment system. In addition, for CY 2009, we finalized our
policy to deny payment for any PHP claims submitted for days when fewer
than 3 units of therapeutic services are provided (73 FR 68694).
Furthermore, for CY 2009, we revised the regulations at 42 CFR
410.43 to codify existing basic PHP patient eligibility criteria and to
add a reference to current physician certification requirements at 42
CFR 424.24 to conform our regulations to our longstanding policy (73 FR
68694 through 68695). These changes have helped to strengthen the PHP
benefit. We also revised the partial hospitalization benefit to include
several coding updates. We refer readers to section X.C.3. of the CY
2009 OPPS/ASC final rule with comment period (73 FR 68695 through
68697) for a full discussion of these requirements.
For CY 2010, we retained the two-tiered payment approach for PHP
services and used only hospital-based PHP data in computing the APC per
diem payment rates. We used only hospital-based PHP data because we
were concerned about further reducing both PHP APC per diem payment
rates without knowing the impact of the policy and payment changes we
made in CY 2009. Because of the 2-year lag between data collection and
rulemaking, the changes we made in CY 2009 were reflected for the first
time in the claims data that we used to determine payment rates for the
CY 2011 rulemaking (74 FR 60556 through 60559).
In CY 2011, in accordance with section 1301(b) of the Health Care
and Education Reconciliation Act of 2010 (HCERA 2010), we amended the
description of a PHP in our regulations to specify that a PHP must be a
distinct and organized intensive ambulatory treatment program offering
less than 24-hour daily care ``other than in an individual's home or in
an inpatient or residential setting.'' In addition, in accordance with
section 1301(a) of HCERA 2010, we revised the definition of a CMHC in
the regulations to conform to the revised definition now set forth at
section 1861(ff)(3)(B) of the Act. We discussed our finalized policies
for these two provisions of HCERA 2010 in section X.C. of the CY 2011
OPPS/ASC final rule with comment period (75 FR 71990).
In the CY 2011 OPPS/ASC final rule with comment period (75 FR
71994), we also established four separate PHP APC per diem payment
rates, two for CMHCs (for Level I and Level II services) and two for
hospital-based PHPs (for Level I and Level II services). In the CY 2011
OPPS/ASC proposed rule, we proposed that CMHC APC medians would be
based only on CMHC data and hospital-based PHP APC medians would be
based only on hospital-based PHP data (75 FR 46300). As stated in the
CY 2011 OPPS/ASC proposed rule (75 FR 46300) and the final rule with
comment period (75 FR 71991), for CY 2011, using CY 2009 claims data,
CMHC costs had significantly decreased again. We attributed the
decrease to the lower cost structure of CMHCs compared to hospital-
based PHP providers, and not the impact of CY 2009 policies. CMHCs have
a lower cost structure than hospital-based PHP providers, in part
because the data showed that CMHCs provide fewer PHP services in a day
and use less costly staff than hospital-based PHPs. Therefore, it was
inappropriate to continue to treat CMHCs and hospital-based providers
in the same manner regarding payment, particularly in light of such
disparate differences in costs. We also were concerned that paying
hospital-based PHPs at a lower rate than their cost structure reflects
could lead to hospital-based PHP closures and possible access problems
for Medicare beneficiaries, given that hospital-based PHPs offer the
widest access to PHP services because they are located across the
country. Creating the four payment rates (two for CMHCs and two for
hospital-based PHPs) based on each provider's data supported continued
access to the PHP benefit, while also providing appropriate payment
based on the unique cost structures of CMHCs and hospital-based PHPs.
In addition, separation of data by provider type was supported by
several hospital-based PHP commenters who responded to the
[[Page 68406]]
CY 2011 OPPS/ASC proposed rule (75 FR 71992).
For CY 2011, we instituted a 2-year transition period for CMHCs to
the CMHC APC per diem payment rates based solely on CMHC data. For CY
2011, under the transition methodology, CMHC APC Level I and Level II
per diem costs were calculated by taking 50 percent of the difference
between the CY 2010 final hospital-based PHP medians and the CY 2011
final CMHC medians and then adding that number to the CY 2011 final
CMHC medians. A 2-year transition under this methodology moved us in
the direction of our goal, which is to pay appropriately for PHP
services based on each provider type's data, while at the same time
allowing providers time to adjust their business operations and protect
access to care for beneficiaries. We also stated that we would review
and analyze the data during the CY 2012 rulemaking cycle and may, based
on these analyses, further refine the payment mechanism. We refer
readers to section X.B. of the CY 2011 OPPS/ASC final rule with comment
period (75 FR 71991 through 71994) for a full discussion.
After publication of the CY 2011 OPPS/ASC final rule with comment
period, a CMHC and one of its patients filed an application for a
preliminary injunction, challenging the OPPS payment rates for PHP
services provided by CMHCs in CY 2011 as adopted in the CY 2011 OPPS/
ASC final rule with comment period (75 FR 71995). We refer readers to
the court case, Paladin Cmty. Mental Health Ctr. v. Sebelius, No. 10-
949, 2011 WL 3102049 (W.D.Tex. 2011), aff'd, No. 11-50682, 2012 WL
2161137 (5th Cir. June 15, 2012) (Paladin). The plaintiffs in the
Paladin case challenged the agency's use of cost data derived from both
hospitals and CMHCs in determining the relative payment weights for the
OPPS payment rates for PHP services furnished by CMHCs, alleging that
section 1833(t)(2)(C) of the Act requires that such relative payment
weights be based on cost data derived solely from hospitals. As
discussed above, section 1833(t)(2)(C) of the Act requires CMS to
``establish relative payment weights for covered OPD services (and any
groups of such services * * *) * * * based on * * * hospital costs.''
Numerous courts have held that ``based on'' does not mean ``based
exclusively on.'' On July 25, 2011, the District Court dismissed the
plaintiffs' complaint and application for preliminary injunction for
lack of subject-matter jurisdiction, which the plaintiffs appealed to
the United States Court of Appeals for the Fifth Circuit. On June 15,
2012, the Court of Appeals affirmed the District Court's dismissal for
lack of subject-matter jurisdiction and found that the Secretary's
payment rate determinations for PHP services are not a facial violation
of a clear statutory mandate. (Paladin at *6).
For CY 2012, as discussed in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74348 through 74352), we determined the relative
payment weights for PHP services provided by CMHCs based on data
derived solely from CMHCs and the relative payment weights for
hospital-based PHP services based exclusively on hospital data. The
statute is reasonably interpreted to allow the relative payment weights
for the OPPS payment rates for PHP services provided by CMHCs to be
based solely on CMHC data and relative payment weights for hospital-
based PHP services to be based exclusively on hospital data. Section
1833(t)(2)(C) of the Act requires the Secretary to ``establish relative
payment weights for covered OPD services (and any groups of such
services described in subparagraph (B)) based on * * * hospital
costs.'' In pertinent part, subparagraph (B) provides that ``the
Secretary may establish groups of covered OPD services * * * so that
services classified within each group are comparable clinically and
with respect to the use of resources.'' In accordance with subparagraph
(B), we developed the APCs, as set forth in 42 CFR 419.31 of the
regulations (65 FR 18446 and 18447; 63 FR 47559 through 47562 and 47567
through 47569). As discussed above, PHP services are grouped into APCs.
Based on section 1833(t)(2)(C) of the Act, we believe that the word
``establish'' can be interpreted as applying to APCs at the inception
of the OPPS in 2000 or whenever a new APC is added to the OPPS. In
creating the original APC for PHP services (APC 0033), we did
``establish'' the initial relative payment weight for PHP services,
provided in both hospital-based and CMHC-based settings, only on the
basis of hospital data. Subsequently, from CY 2003 through CY 2008, the
relative payment weights for PHP services were based on a combination
of hospital and CMHC data. For CY 2009, we established new APCs for PHP
services based exclusively on hospital data. Specifically, we adopted a
two-tiered APC methodology (in lieu of the original APC 0033) under
which CMS paid one rate for days with 3 services (APC 0172) and a
different payment rate for days with 4 or more services (APC 0173).
These two new APCs were established using only hospital data. For CY
2011, we added two new APCs (APCs 0175 and 0176) for PHP services
provided by hospitals and based the relative payment weights for these
APCs solely on hospital data. APCs 0172 and 0173 were designated for
PHP services provided by CMHCs and were based on a mixture of hospital
and CMHC data. As the Secretary argued in the Paladin case, the courts
have consistently held that the phrase ``based on'' does not mean
``based exclusively on.'' Thus, the relative payment weights for the
two APCs for PHP services provided by CMHCs in CY 2011 were ``based
on'' hospital data, no less than the relative payment weights for the
two APCs for hospital-based PHP services.
Although we used hospital data to establish the relative payment
weights for APCs 0033, 0172, 0173, 0175, and 0176 for PHP services, we
believe that we have the authority to discontinue the use of hospital
data in determining the OPPS relative payment weights for PHP services
provided by CMHCs. Other parts of section 1833(t)(2)(C) of the Act make
plain that the data source for the relative payment weights is subject
to change from one period to another. Section 1833(t)(2)(C) of the Act
provides that, in establishing the relative payment weights, ``the
Secretary shall [ ] us[e] data on claims from 1996 and us[e] data from
the most recent available cost reports.'' However, we used 1996 data
(plus 1997 data) in determining only the original relative payment
weights for 2000; in the ensuing calendar year updates, we continually
used more recent cost report data.
Moreover, section 1833(t)(9)(A) of the Act requires the Secretary
to ``review not less often than annually and revise the groups, the
relative payment weights, and the wage and other adjustments described
in paragraph (2) to take into account changes in medical practice,
changes in technology, the addition of new services, new cost data, and
other relevant information and factors.'' For purposes of the CY 2012
update, we exercised our authority under section 1833(t)(9)(A) of the
Act to change the data source for the relative payment weights for PHP
services provided by CMHCs based on ``new cost data, and other relevant
information and factors.''
B. PHP APC Update for CY 2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45094 through 45098
and 45151), we proposed to develop the relative payment weights that
underpin the OPPS using geometric means rather than the current median-
based methodology. We stated that this
[[Page 68407]]
proposal to base the relative payment weights on geometric means would
also apply to the per diem costs used to determine the relative payment
weights for the four PHP APCs (77 FR 45151). We stated that, for PHP
APCs, as with all other OPPS APCs, the proposal to base the relative
payment weights on geometric means rather than medians would not affect
the general process to establish appropriate claims for modeling. We
stated that, as with the current median-based methodology, the PHP APC
per diem payment rates would continue to be calculated by computing a
separate per diem cost for each day of PHP service. When there are
multiple days of PHP services entered on a claim, a unique cost would
continue to be computed for each day of care. However, a geometric mean
would be used to calculate the per diem costs rather than a median. We
stated that the process would still be repeated separately for CMHCs
and hospital-based PHPs using that provider's claims data for the two
categories of days with 3 services and days with 4 or more services. We
stated that the four PHP APC per diem costs would continue to be
included in the scaling of all APCs under the OPPS to the mid-level
office visit (APC 0606). For a detailed discussion of the CY 2013 OPPS
weight scaler, we refer readers to section II.A.4. of this final rule
with comment period.
In the CY 2013 OPPS/ASC proposed rule, for CY 2013, using CY 2011
claims data, we computed proposed CMHC PHP APC geometric mean per diem
costs for Level I (3 services per day) and Level II (4 or more services
per day) services using only CY 2011 CMHC claims data, and hospital-
based PHP APC geometric mean per diem costs for Level I and Level II
services using only CY 2011 hospital-based PHP claims data. These
proposed geometric mean per diem costs were shown in Table 30 of the CY
2013 OPPS/ASC proposed rule (77 FR 45151) and are reprinted below.
[GRAPHIC] [TIFF OMITTED] TR15NO12.058
Under the CY 2013 proposal to base the OPPS relative payment
weights on geometric mean costs, the proposed geometric mean per diem
costs for CMHCs would continue to be substantially lower than the
proposed geometric mean per diem costs for hospital-based PHPs for the
same units of service. For CY 2013, the proposed geometric mean per
diem costs for days with 3 services (Level I) were approximately $88
for CMHCs and approximately $183 for hospital-based PHPs. The proposed
geometric mean per diem costs for days with 4 or more services (Level
II) were approximately $112 for CMHCs and approximately $233 for
hospital-based PHPs. We stated that this analysis indicated that there
continue to be fundamental differences between the cost structures of
CMHCs and hospital-based PHPs.
The CY 2013 proposed geometric mean per diem costs for CMHCs
calculated under the proposed CY 2013 methodology using CY 2011 claims
data also have decreased compared to the CY 2012 final median per diem
costs for CMHCs established in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74352), with per diem costs for Level I services
decreasing from approximately $98 to approximately $88, and costs for
Level II services decreasing from approximately $114 to approximately
$112. In contrast, the CY 2013 proposed geometric mean per diem costs
for hospital-based PHPs calculated under the proposed CY 2013
methodology using CY 2011 claims data have increased compared to the CY
2012 final median per diem costs for hospital-based PHPs, with per diem
costs for Level I services increasing from approximately $161 to
approximately $183, and per diem costs for Level II services increasing
from approximately $191 to approximately $233.
To provide a comparison in the CY 2013 OPPS/ASC proposed rule, we
also calculated PHP median per diem costs for CY 2013 using CY 2011
claims data (77 FR 45151 through 45152). We computed median per diem
costs for each provider type using that provider's claims data for
Level I services and for Level II services. These comparative median
per diem costs were shown in Table 31 of the CY 2013 OPPS/ASC proposed
rule (77 FR 45152) and are reprinted and discussed below.
[[Page 68408]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.059
The proposed geometric mean per diem costs for hospital-based PHPs
for Level I and Level II services calculated under the proposed CY 2013
methodology using CY 2011 claims data would be higher than the median
per diem costs calculated under the current median-based methodology,
using CY 2011 claims data. For hospital-based PHPs, the per diem costs
would increase from approximately $164 under the current median-based
methodology to approximately $183 under the proposed geometric mean-
based methodology for Level I services, and from approximately $225 to
approximately $233 for Level II services.
The proposed geometric mean per diem costs for CMHCs for Level I
services calculated under the proposed CY 2013 methodology using CY
2011 claims data would be approximately the same as the median per diem
costs calculated under the current median-based methodology, using CY
2011 claims data. The proposed geometric mean per diem costs for CMHCs
for Level II services calculated under the proposed CY 2013 methodology
using CY 2011 claims data would be slightly lower than the median per
diem costs calculated under the current median-based methodology, using
CY 2011 claims data. For CMHCs, the per diem costs would be
approximately $88 under both the current median-based methodology and
the proposed geometric mean-based methodology for CMHC Level I
services, and would decrease from approximately $121 under the current
median-based methodology to approximately $112 under the proposed
geometric mean-based methodology for CMHC Level II services.
We stated that the data analysis also shows that the median per
diem costs for CMHCs continue to be substantially lower than the median
per diem costs for hospital-based PHPs for the same units of service
provided. The median per diem costs for Level I services were
approximately $88 for CMHCs and approximately $164 for hospital-based
PHPs. The median per diem costs for Level II services were
approximately $121 for CMHCs and approximately $225 for hospital-based
PHPs. We stated that the significant difference in per diem costs
between CMHCs and hospital-based PHPs emphasizes the distinct cost
structures between the two provider types.
Finally, we stated that the data analysis indicates that CMHC
median per diem costs for Level I services would have decreased from CY
2012 final median per diem costs (using CY 2010 claims data)
(established in the CY 2012 OPPS/ASC final rule with comment period (76
FR 74352)) to CY 2013 (using CY 2011 claims data) from approximately
$98 to approximately $88, using only CMHC claims data. The CMHC median
per diem costs for Level II services would have slightly increased from
CY 2012 final median per diem costs (using CY 2010 claims data) to CY
2013 (using CY 2011 claims data) from approximately $114 to
approximately $121, using only CMHC claims data. Hospital-based PHP
median per diem costs for Level I and Level II services would have
increased from the CY 2012 final median per diem costs (using CY 2010
claims data) to CY 2013 (using CY 2011 claims data) from approximately
$161 to approximately $164 for Level I services and from approximately
$191 to approximately $225 for Level II services, using only hospital
claims data.
In summary, while we have historically based the OPPS payments on
median costs for services in the APC groups, for CY 2013, we proposed
to calculate the relative payment weights for the OPPS APCs using
geometric means, including the four PHP APCs, as discussed in section
II.A.2.f. of the proposed rule. We invited public comments on these
proposals.
Comment: A few commenters representing CMHCs opposed the proposed
conversion from the historically applied median-based methodology to
the geometric mean-based methodology and the resulting CMHC payment
rates. The commenters believed that the median cost approach is more
stable and less sensitive to extreme observations and, therefore, a
more appropriate methodology. One CMHC commenter preferred the median-
based methodology because it resulted in a higher payment rate for the
CMHC APC for Level II services than when calculated using a geometric
mean-based methodology. The commenters recommended that CMS continue
using a median-based methodology and not change to a geometric mean-
based methodology for calculating the per diem costs.
Response: We acknowledge the commenters' concern about the change
from the median-based methodology to the geometric mean-based
methodology and its impact on CMHCs. In the CY 2013 OPPS/ASC proposed
rule, we proposed to develop the OPPS relative
[[Page 68409]]
payment weights using geometric mean cost for all APCs that were
previously calculated using median cost, including the PHP APCs (77 FR
45094 through 45098 and 45151). Under the CY 2013 proposal, OPPS
payments to CMHCs for partial hospitalization also would be calculated
based on geometric mean per diem costs, rather than the previous use of
median per diem costs. This would help ensure that the relativity of
the OPPS payment weights was properly aligned. As discussed in section
II.A.2.f. of this final rule with comment period, we do not believe
that paying for some services based on median costs while using
geometric mean costs for other services is appropriate, equitable, or
consistent with statute. Therefore, our CY 2013 proposal was to develop
the OPPS relative payment weights using geometric mean costs for any
services previously calculated using median costs, whether that was on
a standard, per diem, or line item basis (77 FR 45097).
In the CY 2013 OPPS/ASC proposed rule, we recognized that median
costs had historically served as an appropriate measure on which to
establish relative payment weights. However, in our proposal to
establish the CY 2013 OPPS relative payment weights using geometric
mean cost, we discussed a number of reasons why we believed that
changing to geometric mean cost would represent an incremental
improvement as well as be appropriate. These reasons included changes
CMS has made throughout the history of the OPPS with the goal of
deriving more accurate information from available claims and cost
report data, as well as benefits of using a metric that more accurately
describes the range of costs associated with providing services.
While commenters have suggested that medians are more appropriate
because they are less sensitive to outlier observations, in particular
for CMHCs, we believe that including those outlier observations in
developing the weights and capturing the full range of service costs
will lead to more accurate relative payment weights. In addition to
better incorporating those cost values that surround the median and,
therefore, describing a broader range of cost patterns, basing the
relative payment weights on geometric mean costs may also promote
better stability in the payment system by making OPPS payments more
reflective of the range of costs associated with providing services. In
the short term, geometric mean-based relative payment weights would
make the relative payment weights more reflective of the service costs.
However, making this change also may promote more payment stability in
the long term by including a broader range of observations in the
relative payment weights, making them less susceptible to gaps in
estimated cost near the median observation and also making changes in
the relative payment weight a better function of changes in estimated
service costs.
We note that using the geometric means would increase the relative
payment weights for some services and decrease the relative payment
weights for others. We believe those updated relative payment weights
to be more reflective of the costs associated with providing those
services, which is consistent with the goal of developing relative
payment weights that accurately describe service costs. As described in
the CY 2013 OPPS/ASC proposed rule, we have made a number of changes in
the history of the OPPS to derive more information from what is
available to us and ensure that the cost information we use for
ratesetting is as accurate as possible. We believe that making changes
consistent with those goals is preferable, rather than choosing one
methodology or another simply due to the numeric payment rates that
arise from any different methodology.
Thus, for the reasons discussed above, we believe that using
geometric mean costs to calculate the relative payment weights for the
OPPS represents an improvement to our cost estimation process and will
lead to relative payment weights that are more reflective of service
cost patterns. For these reasons, we disagree with the commenters'
assertion that use of the median-based methodology is a preferable
option. We believe that this change is appropriate and requires all
OPPS services previously paid through median-based calculations
(including CMHC based per diem costs) to transition together to
geometric mean cost calculations to establish accurate cost relativity
in the system. Therefore, we are finalizing the geometric mean-based
methodology in this final rule with comment period. For a more detailed
discussion of geometric mean-based relative payment weights, we refer
readers to section II.A.2.f. of this final rule with comment period.
Comment: Several hospital-based PHP providers supported the
conversion from a median-based methodology to a geometric mean-based
methodology and the resulting hospital-based PHP per diem payments.
These commenters also recommended that CMS continue to recognize the
cost structure differences between hospital-based PHPs and CMHCs by
calculating four separate PHP APCs based on each providers' own unique
data, and stated that it was a necessary improvement to help ensure PHP
access in hospital-based settings for the future. The commenters also
encouraged CMS to continue to refine data analysis strategies that help
bring payment accuracy as well as stability to the partial
hospitalization benefit in order to allow programs that meet the needs
of Medicare beneficiaries to exist.
Response: We appreciate the commenters' support of the two-tiered,
four PHP APC per diem payment rates based on each providers' own unique
data. We continue to believe that it is important to calculate PHP APC
per diem payment rates based on the data for each type of provider in
order to appropriately pay for PHP services, which will support
continued access to quality services. We are constantly monitoring the
OPPS in search of potential refinements that would improve the accuracy
and stability of the payment system. Over the past several years, we
have made changes to PHP APC per diem payment rates to more accurately
align the payments with costs. These changes have included establishing
separate APC per diem payment rates for CMHCs and hospital-based
providers based on each providers' costs as well as a two-tiered APC
per diem payment rate for both CMHC and hospital-based PHPs under which
we pay one amount for days with 3 services and another amount for days
with 4 or more services. As discussed in the CY 2013 OPPS/ASC proposed
rule, we believe that the use of geometric mean costs rather than
median costs in the ratesetting process is another improvement, because
it allows the payment metric to consider a broader range of service
costs among other factors (77 FR 45097). We will continue to monitor
the impact of our payment policies on the PHP benefit and providers.
Comment: A few CMHC providers requested that CMS suspend
implementation of the proposed PHP APC per diem payment rates for CMHCs
and maintain the current CY 2012 CMHC PHP APC per diem payment rates as
a means to preserve CMHCs. The commenters stated that many of the CMHCs
throughout the country have already closed due to CMS' ongoing payment
rate reductions. Another commenter stated that no business in the
United States or anywhere else in the world can survive and continue to
operate after such a decrease over 3 years. The commenter further
stated that it appeared that the goal of CMS was to substantially
reduce the total number of CMHCs participating in the Medicare
[[Page 68410]]
program and consequentially reduce payments nationwide. One commenter
expressed concern that, instead of being rewarded, CMHCs are being
targeted and punished for providing more cost-effective services than
the hospital-based PHPs. This same commenter was ``highly offended'' by
the following sentence from the CY 2012 OPPS/ASC proposed rule (77 FR
45150): ``CMHCs have a lower cost structure than hospital-based PHP
providers, in part because the data showed that CMHCs provide fewer PHP
services in a day and use less costly staff than hospital-based PHPs.''
The commenter stated that the sentence implies ``CMHCs provide less
valuable services than hospital-based PHPs, hire less qualified staff,
and overall perform very poorly compared to hospital based PHPs.''
Several commenters expressed concern that the proposed reductions
to the CMHC PHP APC per diem payment rates could further erode the
viability of the safety net system, and make it more difficult for
patients to receive needed mental health care and services. One of
these commenters also stated that if patients are unable to receive
care in a CMHC, many will have only the emergency departments as a last
resort.
Response: We understand the concerns raised by the commenters
regarding CMHC APC per diem payment rate reductions. We are not
targeting or trying to punish specific providers, and we are not trying
to reduce the number of CMHCs participating in the Medicare program.
However, we continue to believe that it is important to calculate PHP
APC per diem payment rates based on the data for each type of provider
in order to appropriately pay for services. CMHCs' costs have
fluctuated significantly and then generally declined over the years.
CMHCs' costs also have remained significantly lower than hospital-based
PHPs' costs, which have been relatively stable since the inception of
the OPPS. In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74347), we stated that CMHCs have a lower cost structure than hospital-
based PHP providers because the data showed and continue to show that
CMHCs provide fewer PHP services in a day and use less costly staff
than hospital-based PHPs. In other words, hospital-based providers have
traditionally provided more services than CMHCs during a PHP day.
Providing fewer services during a PHP day results in less overhead
expense for the provider; that is, less time the provider needs to pay
staff, less time the provider needs to heat the building, and less time
the provider needs to light the building. Therefore, providing fewer
PHP services during a day directly contributes to a lower overall cost
structure. We did not intend to offend any of our providers. We also
did not mean to imply that, in comparison to hospital-based PHPs, CMHCs
provide inferior, less valuable or poor quality services; we were only
stating the differences in these providers' cost structures based on
our cost analysis.
In light of these differences in cost structures between provider
types, it was inappropriate to continue to treat CMHCs and hospital-
based PHP providers in the same manner. We were concerned that paying
hospital-based PHPs at a lower rate than their cost structure reflects
could lead to closures and possible access problems for hospital-based
programs providing services to Medicare beneficiaries, given that
hospital-based PHPs offer the widest access to PHP services because
they are located across the country. Paying providers based on the four
PHP APC per diem payment rates supports continued access to the PHP
benefit, while also providing appropriate payment based on the unique
cost structures of CMHCs and hospital-based PHPs. We believe that the
CMHC APC per diem payment rates accurately reflect the cost data of the
CMHCs.
The PHP APC per diem payment rates are directly related to the
accuracy of the claims and cost reports submitted by providers. It is
imperative that providers submit accurate claims and cost reports in
order for the payment rates to most accurately reflect the providers'
costs. The resulting PHP APC per diem payment rates reflect the cost of
what providers expend to maintain such programs. So, it is unclear why
this would lead to program or business closures. As we stated in the CY
2012 OPPS/ASC final rule with comment period (76 FR 74350), the closure
of PHPs may be due to any number of reasons, such as poor business
management or marketing decisions, competition, over-saturation of
certain geographic areas, and Federal and State fraud and abuse
efforts, among others. It does not directly imply that closure could be
due to reduced payment rates alone, especially when these payment rates
reflect the costs of PHP providers.
In response to the commenters' concerns that further reduction in
the CMHC PHP APC per diem payment rates could further erode the
viability of the safety net system and make it more difficult for
patients to receive needed mental health services, we take such
concerns seriously. Currently, we monitor facility closings and
openings to make sure that access issues do not exist, and we will
continue to do so in the future. We also remain steadfast in our
concern regarding access to care for all beneficiaries, while also
providing appropriate payments for such care. A PHP is not the only
program in which a Medicare beneficiary is able to receive needed
mental health care. Although not equivalent to a PHP, Medicare provides
payment for outpatient mental health services in addition to PHP
services. Many beneficiaries in need of mental health treatment receive
other outpatient services generally from hospital programs which are
available nationwide, and no evidence suggests that there is an
increase in adverse outcomes due to lack of access to care. Other forms
of access to mental health services remain available. We continue to
believe that it is important to calculate PHP APC per diem payment
rates based on the data of each type of provider in order to
appropriately pay for PHP services, which will support continued access
to quality services.
Commenters also requested that we suspend implementation of the
proposed CY 2013 PHP APC per diem payment rates for CMHCs, and that we
pay based on the CY 2012 per diem payment rates to preserve CMHCs. As
discussed above, we cannot establish payment rates that do not
accurately reflect the current cost data. We believe that having
separate payment rates for CMHCs and hospital-based providers based on
each providers' costs as well as a two-tiered APC per diem payment rate
for both CMHC and hospital-based PHPs under which we pay one amount for
days with 3 services and another amount for days with 4 or more
services along with using geometric means to more accurately reflect
the costs associated with providing OPPS services supports the PHP
benefit and pays providers appropriately for the services that they
provide. For these reasons, we are not suspending implementation of the
CY 2013 PHP APC per diem payment rates for CMHCs.
Comment: One commenter stated that the database of claim payments
used in calculating the new payment rates includes at least two
providers indicted for fraud, and recommended that these claims be
removed.
Response: We strive to ensure that the claims we use for modeling
the OPPS payment rates contain accurate cost information on services.
In addition, we note that providers with questionable data are subject
to further investigation. We request that the commenter provide us with
more details regarding those providers.
Comment: One commenter suggested that, instead of calculating the
PHP APC
[[Page 68411]]
per diem payment rates using claims data, CMS should use the quality of
the provided services to base payments, including record reviews,
denials due to lack of medical necessity or inadequate documentation,
site visits, interviews with patients, and most importantly patient
outcomes. Another commenter recommended that CMS establish quality and
outcome criteria to judge performance that would influence future
ratesetting, and provide rewards to individual providers for
outstanding quality and outcomes.
Response: Sections 1833(t)(2) and 1833(t)(9) of the Act set forth
the requirements for establishing and adjusting the OPPS payment rates,
including the PHP payment rates. The existing policies and procedures
implementing these statutory provisions do not consider quality
measures when setting base payment rates. However, we note that section
1833(t)(17) of the Act implements an outpatient quality reporting
program for subsection (d) hospitals that applies a payment reduction
for hospitals that fail to meet the program requirements.
Comment: One commenter requested that CMS establish a ratesetting
task force to review the CMS ratesetting methodology and CMHCs' and
hospital-based PHPs' costs as a means to identify fair and adequate
payment rates for both. Another commenter requested an open discussion
with CMS and associations whose members are PHP providers.
Response: We maintain positive working relationships with various
industry leaders representing both CMHCs and hospital-based PHP
providers with whom we have consistently met over the years to discuss
industry concerns and ideas. These relationships have provided
significant and valued input regarding PHP ratesetting. We also hold
Hospital Outpatient Open Door Forum calls monthly, in which all
individuals are welcome to participate and/or submit questions
regarding specific issues, including questions related to PHPs.
Furthermore, we initiate rulemaking annually, through which we
receive public comments on proposals set forth in a proposed rule and
respond to those comments in a final rule. All individuals are provided
an opportunity to comment, and we give consideration to each comment
that we receive.
Given the relationships that we have established with various
industry leaders and the various means for us to receive comments and
recommendations, we believe that we receive adequate input regarding
ratesetting and take that input into consideration when establishing
the payment rates. We continue to welcome any input and information
that the industry is willing to provide.
Comment: A few commenters addressed issues related to the costs
used to calculate the PHP APC per diem payment rates. One commenter
expressed concern that CMS' ratesetting methodology does not take into
consideration the array of services that are delivered in PHPs, such as
assisting with appointments regarding social security and Medicare;
housing searches; primary healthcare; eye and dental services; working
with families; obtaining prescription medications; and accessing
transportation, food banks and food stamps.
Two commenters expressed concern that CMHCs must retain the same
level of licensed staff as hospital-based PHPs, yet the discrepancy
between the proposed CMHC and hospital-based PHP per diem payment rates
is now significant. The commenters stated that because all PHPs must
hire psychiatrists, licensed clinicians, licensed supervisors, and
bachelor-level case managers, it is difficult to understand why and how
CMS calculated such different payment rates for essentially the same
services.
Lastly, one commenter further questioned why a licensed therapist
in a community-based treatment setting can be paid $110.27 for a 45 to
50 minute individual counseling session, while a CMHC is expected to
deliver up to 6 hours of care per day including treatment, food,
transportation, among others, for $111.89 per day (for 4 or more
services).
Response: Section 1861(ff) of the Act and 42 CFR 410.43 describe
the items and services included in partial hospitalization services. As
set forth in these sections, partial hospitalization services generally
consist of a variety of group, individual, and family psychotherapy
sessions, supplemented with occupational therapy, the services of
social workers, trained psychiatric nurses, and other staff trained to
work with psychiatric patients, drugs and biologicals furnished for
therapeutic purposes that cannot be self-administered, diagnostic
services, education and training, and certain activity therapies
designed to stabilize an acute episode of mental illness. The PHP APC
per diem payment rate is the bundled payment for these partial
hospitalization services. Physician services that meet the requirements
of Sec. 415.102(a) for payment on a fee schedule basis, physician
assistant services, nurse practitioner and clinical nurse specialist
services, and qualified psychologist services are separately covered
(as are services furnished to skilled nursing facility residents as
defined in Sec. 411.15(p)) and are not paid as partial hospitalization
services (Sec. 410.43(b)). Further, section 1861(ff)(2)(I) of the Act
explicitly excludes meals and transportation from the items and
services included in partial hospitalization services.
Regarding the concern about the discrepancy between the proposed
CMHC and hospital-based PHP per diem payment rates, as discussed above,
we believe that it is important to calculate PHP APC per diem payment
rates based on the data for each type of provider in order to
appropriately pay for services. We base the PHP APC per diem payment
rates on claims and cost reports submitted by providers. The resulting
PHP APC per diem payment rates reflect the cost of what providers
expend to maintain such programs.
In response to the commenter who questioned why the payment to a
CMHC for a full day of mental health treatment is about the same as the
amount a therapist is paid for one individual counseling session, we
believe the commenter is comparing the professional fee the therapist
is paid under the MPFS for providing a therapy service ($110.27,
according to the commenter) to the proposed Level II APC per diem
payment rate to a CMHC under the OPPS for CY 2013 ($111.89). We believe
that this is not an appropriate comparison because these payments are
for completely different services. It is important to note that CMHCs
receive the per diem amount per person per day. Thus, assuming the PHP
has 10 patients, the facility is receiving over $1,000 for the day.
That amount, which is intended to cover the facility's per diem cost
for a day of PHP, includes the cost of staff who are not authorized to
bill Medicare Part B as discussed above. Again, we base the PHP APC per
diem payment rates on claims and cost reports submitted by providers.
Thus, resulting PHP APC per diem payment rates reflect the cost of what
providers expend to maintain such programs.
In summary, after consideration of the public comments we received,
we are finalizing our CY 2013 proposal, without modification, to update
the four PHP APC per diem payment rates based on geometric mean cost
levels calculated using the most recent claims data for each provider
type. The updated PHP APCs geometric mean per diem costs for PHP
services that we are finalizing for CY 2013 are shown in Tables 39 and
40 below. We will continue our efforts to explore payment
[[Page 68412]]
reforms that will support quality and result in greater payment
accuracy and reduction of fraud and abuse within the partial
hospitalization program.
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C. Coding Changes
CPT codes are established by the AMA and the Level II HCPCS codes
are established by the CMS HCPCS Workgroup. CPT and Level II HCPCS
codes are used to report procedures, services, and items and supplies
under the hospital OPPS. These codes are updated and changed throughout
the year.
Subsequent to the publication of the CY 2013 OPPS/ASC proposed
rule, the AMA's CPT Editorial Panel deleted 28 psychiatric CPT codes,
including those related to PHP services, and replaced them with 12 new
CPT codes, effective January 1, 2013. For a detailed explanation of the
OPPS treatment of new, deleted or revised CPT and Level II HCPCS codes
we refer readers to section III.A. of this final rule with comment
period. As a result of the AMA's CPT coding changes to the psychiatric
CPT codes, we are making corresponding changes to the PHP code set that
is used for billing and documenting PHP services. Specifically, we are
making the following changes:
The initial E/M codes are being separated based on whether
the service was completed by a physician (CPT code 90792 (Initial
evaluation with medical services done by a physician)), or a
nonphysician (CPT code 90791 (Initial evaluation done by a non-
physician)). Currently, for PHPs, E/M services are billed under: CPT
codes 90801 (Psychiatric diagnostic interview examination) and 90802
(Interactive psychiatric diagnostic interview). Effective January 1,
2013, CPT codes 90801 and 90802 will be deleted and the E/M services
will be billed using the following CPT codes: CPT code 90791
(Psychiatric diagnostic evaluation (no medical services) when completed
by a non-physician) and CPT code 90792 (Psychiatric diagnostic
evaluation (with medical services) when completed by a physician).
The psychotherapy codes will no longer be for a range of
time, but for a specific period of time. The following CPT codes that
are currently used to bill for and document PHP individual
psychotherapies will be deleted in CY 2013: CPT code 90816 (Psytx hosp
20-30 min); CPT code 90817 (Psytx hosp 20-30 min w/e&m); CPT code 90818
(Psytx hosp 45-50 min); CPT code 90819 (Psytx hosp 45-50 min w/e&m);
CPT code 90821 (Psytx hosp 75-80 min); CPT code 90822 (Psytx hosp 75-80
min w/e&m); CPT code 90823 (Intac psytx hosp 20-30 min); CPT code 90824
(Intac psytx hsp 20-30 w/e&m); CPT code 90826 (Intac psytx hosp 45-50
min); CPT code 90827 (Intac psytx hsp 45-50 w/e&m); CPT code 90828
(Intac psytx hosp 75-80 min); and CPT code 90829 (Intac psytx hsp 75-80
w/e&m). These codes will be replaced with the following new
psychotherapy CPT codes: CPT codes 90832 (Psychotherapy, 30 minutes);
CPT codes 90834 (Psychotherapy, 45 minutes); and CPT codes 90837
(Psychotherapy, 60 minutes). If the time spent for psychotherapy is
more than half the time of the code, then that code can be used to bill
for PHP services. For example, if the time spent for psychotherapy is
16 minutes up to 37 minutes, CPT code 90832 (Psychotherapy, 30 minutes)
would be used. For psychotherapy lasting 38 to 52 minutes, CPT code
90834 (Psychotherapy, 45 minutes) would be used, and for psychotherapy
lasting 53 minutes or more, CPT code 90837 (Psychotherapy, 60 minutes)
would be used. When psychotherapy is provided during the same encounter
as an E/M service, there will be timed add-on CPT codes for
psychotherapy that are to be used by psychiatrists to indicate that
psychotherapy was provided during the same encounter as an E/M service.
When E/M services are completed with
[[Page 68413]]
psychotherapy, the following CPT codes may be used effective January 1,
2013: Appropriate E/M code (not selected on basis of time) and CPT code
+90833 (30-minute psychotherapy add-on code); Appropriate E/M code (not
selected on basis of time) and CPT code +90836 (45-minute psychotherapy
add-on code); and Appropriate E/M code (not selected on basis of time)
and CPT code +90838 (60-minute psychotherapy add-on code). The
following table provides a list of the PHP-related individual
psychotherapy CPT codes that will be deleted December 31, 2012.
BILLING CODE 4120-01-P
[[Page 68414]]
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[[Page 68415]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.062
Instead of separate codes for interactive psychotherapy,
there is now an add-on CPT code for interactive complexity, which may
be used when the patient encounter is more complex because of the need
to involve people other than the patient (CPT code +90785). This add-on
CPT code can be used with initial evaluation codes, with the
psychotherapy codes, with the nonfamily group psychotherapy code, and
with the E/M codes when they are used in conjunction with psychotherapy
services. The CPT manual includes specific guidelines as to what
constitutes interactive complexity that should be understood before
this add-on CPT code is used. Documentation must clearly indicate
exactly what the complexity was.
Beginning on January 1, 2013, interactive psychotherapy should be
billed using the psychiatric evaluation codes, the psychotherapy and
psychotherapy add-on CPT codes, and the group (nonfamily) psychotherapy
CPT code +90785 (Interactive psychotherapy).
Relevant coding requirements must be followed. We recommend
learning how to accurately bill for and document these new codes. More
information may be found on the CPT/AMA Web site: http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt.page.
All other PHP CPT and HCPCS codes will remain unchanged and active
for billing and documentation of PHP services. We refer readers to the
table below that highlights which PHP CPT/HCPCS codes are changing and
which PHP CPT/HCPCS codes will remain unchanged and active for billing
and documentation of services.
The following Table 42 provides a crosswalk between the CPT/HCPCS
code options in CY 2012 and the CPT/HCPCS code options that are
effective on January 1, 2013.
[[Page 68416]]
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[[Page 68417]]
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The following Table 43 shows all of the billable PHP revenue and
CPT/HCPCS codes effective on January 1, 2013. This table is also
located in the Medicare Claims Processing Manual, Pub. 100-04, Chapter
4, Section 260.1, which is available on the CMS Web site at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf.
[[Page 68418]]
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D. Separate Threshold for Outlier Payments to CMHCs
In the CY 2004 OPPS final rule with comment period (68 FR 63469
through 63470), we indicated that, given the difference in charges for
PHP services provided between hospitals and CMHCs, we did not believe
it was appropriate to make outlier payments to CMHCs using the outlier
percentage target amount and threshold established for hospitals. Prior
to that time, there was a significant difference in the amount of
outlier payments made to hospitals and CMHCs for PHP services.
Therefore, we designated a portion of the estimated OPPS outlier target
amount specifically for CMHCs, consistent with the percentage of
projected payments to CMHCs under the OPPS each year, excluding outlier
payments. In addition, further analysis indicated that using the same
OPPS outlier threshold for both hospitals and CMHCs did not limit
outlier payments to high-cost cases and resulted in excessive outlier
payments to CMHCs. Therefore, beginning in CY 2004, we established a
separate outlier threshold for CMHCs. The separate outlier threshold
for CMHCs has resulted in more commensurate outlier payments.
The separate outlier threshold for CMHCs resulted in $1.8 million
in outlier payments to CMHCs in CY 2004, and $0.5 million in outlier
payments to CMHCs in CY 2005. In contrast, in CY 2003, more than $30
million was paid to CMHCs in outlier payments. We believe this
difference in outlier payments indicates that the separate outlier
threshold for CMHCs has been successful in keeping outlier payments to
CMHCs in line with the percentage of OPPS payments made to CMHCs.
We proposed in the CY 2013 OPPS/ASC proposed rule (77 FR 45153) to
continue our policy of identifying 1.0 percent of the aggregate total
payments under the OPPS for outlier payments for CY 2013. We proposed
that a portion of that 1.0 percent, an amount equal to 0.12 percent of
outlier payments (or 0.0012 percent of total OPPS payments) would be
allocated to CMHCs for PHP outlier payments. In section II.G. of the CY
2013 OPPS/ASC proposed rule, for the hospital outpatient outlier
payment policy, we proposed to set a dollar threshold in addition to an
APC multiplier threshold (77 FR 45110 through 45111). Because the PHP
APCs are the only APCs for which CMHCs may receive payment under the
OPPS, we would not expect to redirect outlier payments by imposing a
dollar threshold. Therefore, we did not propose to set a dollar
threshold for CMHC outlier payments. We proposed to set the outlier
threshold for CMHCs for CY 2013 at 3.40 times the APC payment amount
and the CY 2013 outlier payment percentage applicable to costs in
excess of the threshold at 50 percent. Specifically, we proposed to
establish that if a CMHC's cost for partial hospitalization services,
paid under either APC 0172 or APC 0173, exceeds 3.40 times the payment
rate for APC 0173, the outlier payment will be calculated as 50 percent
of the amount by which the cost exceeds 3.40 times the APC 0173 payment
rate. We invited public comments on these proposals.
We did not receive any public comments regarding our proposed
outlier policy. Therefore, we are finalizing our CY 2013 proposal to
set a separate outlier threshold for CMHCs. As discussed in section
II.G. of this final rule with comment period, using more recent data
for this final rule with comment period, we set the target for hospital
outpatient outlier payments at 1.00 percent of total estimated OPPS
payments. We allocated a portion of that 1.00 percent, an amount equal
to 0.12 percent of outlier payments or 0.0012 percent of total
estimated OPPS payments to CMHCs for PHP outlier payments. For CY 2013,
as proposed, we are setting the outlier threshold at 3.40 multiplied by
the APC payment amount and the CY 2013 outlier percentage applicable to
costs in excess of the threshold at 50 percent.
IX. Procedures That Would Be Paid Only as Inpatient Procedures
A. Background
We refer readers to the CY 2012 final rule with comment period (76
FR 74352 through 74353) for a full historical discussion of our
longstanding policies on how we identify procedures that are typically
provided only in an inpatient setting (referred to as the inpatient
list) and, therefore, will not be paid by Medicare under the OPPS; and
on the criteria that we use to review the inpatient list each year to
determine whether or not any procedures should be removed from the
list.
B. Changes to the Inpatient List
In the CY 2013 OPPS/ASAC proposed rule (77 FR 45153), for CY 2013,
we proposed to use the same methodology (described in the November 15,
2004 final rule with comment period (69 FR 65835)) of reviewing the
current list of procedures on the inpatient list to
[[Page 68419]]
identify any procedures that are being performed a significant amount
of the time on an outpatient basis, and appropriately may be removed
from the list. The established criteria upon which we make such a
determination are as follows:
1. Most outpatient departments are equipped to provide the services
to the Medicare population.
2. The simplest procedure described by the code may be performed in
most outpatient departments.
3. The procedure is related to codes that we have already removed
from the inpatient list.
4. A determination is made that the procedure is being performed in
numerous hospitals on an outpatient basis.
5. A determination is made that the procedure can be appropriately
and safely performed in an ASC, and is on the list of approved ASC
procedures or has been proposed by us for addition to the ASC list.
Using this methodology, we identified two procedures that
potentially could be removed from the inpatient list for CY 2013: CPT
code 22856 (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy with end plate preparation (includes
osteophytectomy for nerve root or spinal cord decompression and
microdissection), single interspace, cervical); and CPT code 27447
(Arthroplasty, knee, condyle and plateau; medical and lateral
compartments with or without patella resurfacing (total knee
arthroplasty)). We then reviewed the clinical characteristics and
related evidence for these two potential procedures for possible
removal from the inpatient list and found them to be appropriate
candidates for removal from the inpatient list. For CY 2013, we
proposed to remove the procedures described by CPT codes 22856 and
27447 from the inpatient list because we believe that the procedures
may be appropriately provided as hospital outpatient procedures for
some Medicare beneficiaries, based upon the evaluation criteria
mentioned above and should thus be paid under the OPPS.
The two procedures that we proposed to remove from the inpatient
list for CY 2013 and their CPT codes, long descriptors, proposed APC
assignments, and proposed status indictors were displayed in Table 34
of the proposed rule.
Comment: A few commenters supported CMS' proposal to remove CPT
code 27447 (Total knee arthroplasty) from the list of inpatient
procedures, and asserted that this procedure may be appropriately
provided on an outpatient basis for some Medicare beneficiaries, given
thorough preoperative screening by medical teams with significant
experience and expertise involving knee replacement procedures. The
commenters referenced a study presented at the American Academy of
Orthopedic Surgeons 2009 annual meeting, which noted recent advances in
total knee replacement procedures, including improved perioperative
anesthesia, and expedited rehabilitation protocols, as well as
significant enhancements to the postoperative process, such as
improvements in pain management, early mobilization, careful
monitoring, and that early preventive intervention for the most common
medical complications have decreased the average length of hospital
stays to the point that total knee arthroplasty can now be performed on
an outpatient basis in certain cases. The commenters noted significant
success involving same day discharge for patients who met the screening
criteria and whose experienced medical teams were able to perform the
procedure early enough in the day for the patients to achieve
postoperative goals, allowing home discharge by the end of the day. The
commenters remarked that the benefits of providing total knee
arthroplasty on an outpatient basis will lead to significant
enhancements in patient well-being and cost savings to the Medicare
program, including shorter hospital stays resulting in fewer medical
complications, improved results, and enhanced patient satisfaction.
A few commenters urged CMS to group total knee arthroplasty into a
new APC with unicompartmental knee replacement or to group these two
procedures with other clinically similar orthopedic implant procedures
from APC 0425 to create a more clinically homogenous APC for resource-
intensive arthroplasty, if CMS finalized its proposal to remove total
knee arthroplasty from the inpatient list. One commenter requested CMS
to assign CPT code 27447 a status indicator of ``S.''
The majority of commenters asked that CMS retract its proposal to
remove CPT code 27447 from the inpatient list. Commenters argued that
CPT code 27447 is not being performed in numerous hospitals on an
outpatient basis and noted that the published average length of stay
for this procedure is over 3 days, with a recommended best practice
target of 3 days when no complications exist. Commenters stated that
removing CPT code 27447 from the inpatient list will create a dangerous
situation for Medicare beneficiaries, who are older and more medically
complex patients, as there are serious potential adverse effects,
including inadequate pain management, unsafe ambulation, and risk for
falls. Commenters also noted that patients undergoing total knee
replacement often have several comorbidities and increased risks, such
as death, loss of a limb, nerve damage resulting from neurovascular
injury, myocardial infarction (MI), pulmonary embolism (PE), deep vein
thrombosis (DVT), and infection and loss of mobility, as well as
anaphylaxis, obstructive sleep apnea, and aspiration of stomach
contents into the lungs. Several commenters stated that many patients
will require some type of sub acute rehabilitation, which could include
a SNF, and if these patients are not admitted, they will not meet their
qualifying 3-day inpatient stay and will not be eligible for SNF care,
which likely will lead to poor outcomes postoperatively. Some
commenters stated that Medicare patients require greater than 24 hours
of inpatient hospital care following total knee replacement procedures
for clinical reasons, including anesthesia recovery, physical therapy,
blood loss monitoring, and pain control, which often includes
intravenous pain medications for 24 to 48 hours following the
procedure, and the outpatient setting cannot handle the high acuity for
the extended postoperative care that this type of patient requires.
Other commenters stated that they do not believe that the clinical
characteristics of CPT code 27447 justify its selection as an
appropriate candidate for removal from the inpatient list.
Commenters pointed out that, while Medicare's definition of
outpatient surgery specified that it includes the care provided during
the normal recovery period, which is defined as less than 24 hours, the
length of stay for total knee arthroplasty patients is markedly longer
than 24 hours for outpatient surgery recovery. In addition, the
commenters noted that, according to the Medicare Claims Processing
Manual, Chapter 4, section 180.7, `` `Inpatient only' services are
generally, but not always, surgical services that require inpatient
care because of the nature of the procedure, the typical underlying
physical condition of patients who require the service, or the need for
at least 24 hours of postoperative recovery time or monitoring before
the patient can be safely discharged.'' Several commenters cited the
lack of any evidence-based publications supporting outpatient total
knee arthroplasty in
[[Page 68420]]
patients over the age of 65 and asserted that patients having total
knee replacement surgery as outpatients were significantly more likely
to die or need readmission within 90 days, compared with inpatients
remaining in the hospital for 3 to 4 days, according to a study
presented at the February 2012 American Association of Orthopedic
Surgery meeting. Commenters also noted, according to the same study,
the rates of subsequent revision surgery were nearly doubled in
patients having 1-day hospital stays compared with the 3- to- 4-day
standard.
Commenters further noted that performing total knee arthroplasty in
the outpatient setting may impact the types of rehabilitation services
available to patients upon completion of the surgery, and may make
justifying the medical necessity of inpatient rehabilitation more
difficult. Furthermore, commenters expressed concern that commercial
carriers will change total knee arthroplasty to an outpatient
procedure, thereby making it more difficult to get such a procedure
authorized.
Commenters also stated that all hospitals do not have the robotics
available for less invasive surgical technique and only a few centers
across the country are routinely doing knee replacement as outpatients,
and even those hospitals are doing them on specific patient types. One
commenter remarked that, while outpatient joint replacements are
possible in hospitals in major cities with large resources and an
educated skilled support staff, it would be dangerous to the patient to
perform outpatient total knee arthroplasties in small rural
communities, as there are limited nurses, therapists, and other support
staff in many communities across the country.
Some commenters expressed concern about the effects of CMS'
proposed removal of CPT 27447 on participants in the CMS Innovation
Center's (CMMI's) Bundled Payments for Care Improvement (BPCI)
initiative.
Response: We appreciate all of the public comments we received on
the removal of CPT code 27447 from the inpatient list. In light of all
of these public comments, for CY 2013, we have decided not to remove
CPT code 27447 from the inpatient list as we proposed. Based on the
public comments, we have concerns regarding whether this procedure may
be appropriately provided as a hospital outpatient procedure for some
Medicare beneficiaries based upon the evaluation criteria above.
Comment: The majority of commenters supported CMS' proposal to
provide payment for CPT code 22856 in the hospital outpatient setting,
but recommended assigning CPT code 22856, as well as CPT codes 22551
and 22554, to APC 0052 (Level IV Musculoskeletal Procedures Except Hand
and Foot), APC 0425 (Level II Arthroplasty or Implantation of
Prosthesis), or a newly created APCs in order to appropriately
compensate hospitals for their costs associated with this procedure.
One commenter believed that CPT code 22856, for patient safety reasons,
should remain on the inpatient list.
Response: We appreciate commenters' support of our proposal to
provide payment for CPT code 22856 in the hospital outpatient setting.
We believe that this procedure may be appropriately provided as a
hospital outpatient procedure for some Medicare beneficiaries based
upon the evaluation criteria above. However, we do not agree with the
commenters' recommendation to assign CPT code 22856, as well as CPT
codes 22551 and 22554, to APC 0052, 0425, or a newly created APC. We
believe that CPT code 22856, as well as CPT codes 22551 and 22554, are
appropriately placed in APC 0208.
Comment: Several commenters requested that CMS remove 39 additional
CPT codes from the CY 2012 inpatient list based on their own
experience, specialty society recommendation, or designation of a
procedure as safe in the outpatient setting under one of the many
clinical guidelines available.
Response: We reevaluated data on the 39 additional CPT codes
requested by the commenters, using more recent utilization data and
further clinical review by CMS medical advisors. These codes are listed
in Table 44 below. As a result of the reevaluation, we remain convinced
that these procedures can be safely performed only in the inpatient
setting.
BILLING CODE 4120-01-P
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[[Page 68422]]
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[[Page 68423]]
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BILLING CODE 4120-01-C
Comment: Some commenters requested that CMS add CPT codes 44206
(Laparoscopy, surgical; colectomy, partial, with end colostomy and
closure of distal segment (Hartmann type procedure)), 44207
(Laparoscopy, surgical; colectomy, partial, with anastomosis, with
coloproctostomy (low pelvic anastomosis)), 44208 (Laparoscopy,
surgical; colectomy, partial, with anastomosis, with coloproctostomy
(low pelvic anastomosis) with colostomy), and 44213 (Laparoscopy,
surgical, mobilization (take-down) of splenic flexure performed in
conjunction with partial colectomy (List separately in addition to
primary procedure)) to the inpatient list.
Response: We note that CPT codes 44206, 44207, 44208, and 44213
have been payable in the outpatient setting for a number of years
without significant concern raised by the public. Therefore, we find no
reason to reassign CPT codes 44206, 44207, 44208, and 44213 to the
inpatient list at this time.
Comment: A number of commenters requested that the inpatient list
be eliminated in its entirety, and if the inpatient list cannot be
eliminated in its entirety, an appeals process be developed. Commenters
also requested that the inpatient list be reviewed clinically. In
addition, commenters expressed concern about the way Recovery Audit
Contractors (RACs) target procedures removed from the inpatient list
and encouraged CMS to provide a period to allow hospitals to make the
appropriate adjustments without being at risk of an audit. The
commenters urged CMS to provide, in both regulatory language and
transmittals, that procedures with APC payment rates can be performed,
covered, and paid by Medicare on an inpatient basis when medical
necessity is documented and the physician has ordered inpatient status.
Response: We appreciate these comments and thoughtful suggestions.
We continue to believe that the inpatient list is a valuable tool for
ensuring that the OPPS only pays for services that can safely and
appropriately be performed in the hospital outpatient setting, and we
will not eliminate the inpatient only list at this time. We do not plan
to adopt a specific appeals process for claims related to inpatient
procedures performed in the HOPD in light of the added administrative
burden, and the existing processes established for a beneficiary or a
provider to appeal a specific claim remain in effect. We are committed
to clinically reviewing the inpatient list timely to reflect changes in
medical practice, and we plan to continue our current practice of
reviewing procedures for removal from the inpatient list through the
formal notice-and-comment rulemaking process. The inpatient list is
made available to the public through the OPPS/ASC final rule with
comment period at least 60 days prior to its effective date of January
1 of the upcoming year. We believe that the 60 days between the release
of the OPPS/ASC final rule with comment period and the effective date
of January 1 of the upcoming year provide sufficient time for hospitals
to make the appropriate adjustments to reflect the upcoming year's
inpatient list. As we have stated in Section 180.7 of Chapter 4 of the
Medicare Claims Processing Manual, procedures removed from the
inpatient list may be appropriately furnished in either the inpatient
or outpatient settings and such procedures continue to be payable when
furnished in the inpatient setting.
Comment: One commenter who responded to the CY 2012 OPPS/ASC final
rule with comment period supported CMS' decision to assign a status
indicator of ``C'' to Category III codes 0293T (Insertion of left
atrial hemodynamic monitor; complete system, includes implanted
communication module and pressure sensor lead in left atrium including
transseptal access, radiological supervision and interpretation, and
associated injection procedures, when performed) and 0294T (Insertion
of left atrial hemodynamic monitor; pressure sensor lead at time of
insertion of pacing cardioverter-defibrillator pulse generator
including radiological supervision and interpretation and associated
injection procedures, when performed (list separately in addition to
primary procedure)).
Response: We appreciate the commenter's support.
At its August 27-28, 2012 meeting, the Panel recommended that CMS
remove HCPCS code 22856 from the list of inpatient procedures. We are
accepting this recommendation.
After consideration of the public comments we received, we are
modifying our proposal and only removing CPT code 22856 from the CY
2013 inpatient list. CPT code 27447 will remain on the inpatient list
for CY 2013.
The procedure that we are removing from the inpatient list for CY
2013 and its CPT code, long descriptor, APC assignment, and status
indictor are displayed in Table 45 below.
[[Page 68424]]
[GRAPHIC] [TIFF OMITTED] TR15NO12.069
The complete list of codes to be paid by Medicare in CY 2013 only
as inpatient procedures is included as Addendum E to this final rule
with comment period (which is available via the Internet on the CMS Web
site).
X. Policies for the Supervision of Outpatient Services in Hospitals and
CAHs
A. Conditions of Payment for Physical Therapy, Speech-Language
Pathology, and Occupational Therapy Services in Hospitals and CAHs
In the CY 2012 OPPS/ASC final rule with comment period (76 FR 74360
through 74371), we clarified that hospital outpatient therapeutic
services and supplies, including those described by benefit categories
other than the hospital outpatient ``incident to'' category under
section 1861(s)(2)(B) of the Act, are subject to the conditions of
payment in 42 CFR 410.27 when they are paid under the OPPS or paid to
CAHs under section 1834(g) of the Act. We issued this clarification in
response to inquiries regarding the application of these conditions of
payment to radiation therapy services that are described under section
1861(s)(4) of the Act when these services are furnished to hospital
outpatients.
In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74369), in our response to public comments on the CY 2012 OPPS/ASC
proposed rule, we indicated that the supervision and other requirements
of Sec. 410.27 do not apply to professional services or to services
that are paid under other fee schedules such as the Clinical Laboratory
Fee Schedule (CLFS). After the publication of the CY 2012 OPPS/ASC
final rule with comment period, we continued to receive questions about
the applicability of the regulations to physical therapy (PT), speech-
language pathology (SLP), and occupational therapy (OT) services
furnished in CAHs. Several stakeholders expressed concern that the
rules could be applied differently in CAHs than in OPPS hospitals. The
stakeholders were concerned that OPPS hospitals, which are paid for
outpatient therapy services at the applicable amount based on the
Medicare Physician Fee Schedule (MPFS), would not be subject to the
regulations, but that CAHs, which are paid for outpatient therapy
services on a reasonable cost basis, would be subject to them.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45154), we clarified
that it was not our intent in the CY 2012 OPPS/ASC final rule with
comment period to establish different requirements for CAHs and for
OPPS hospitals for the same services. We clarified that the limited set
of PT/SLP/OT services that are paid under the OPPS are subject to the
supervision requirements in Sec. 410.27, whether they are furnished in
OPPS hospitals or CAHs. The PT/SLP/OT services that are not paid under
the OPPS and are paid instead at the applicable amount based on the
MPFS are not subject to the supervision requirements in Sec. 410.27,
whether they are furnished in OPPS hospitals or in CAHs.
Comment: Commenters expressed appreciation and support for the
clarification in the proposed rule. One commenter requested that CMS
rescind the requirement of direct supervision for all PT/SLP/OT
services, regardless of whether they are furnished as therapy services
and paid at the applicable amount under the MPFS or are furnished as
nontherapy services and paid under the OPPS.
Response: Stakeholders may direct requests for changes in the
minimum required level of supervision for therapeutic services,
including therapy or other services that are hospital outpatient
services, to the independent review process that we established for
considering such requests in the CY 2012 OPPS/ASC final rule with
comment period. The instructions for submitting a request are discussed
in the CY 2012 final rule with comment period and are available on the
CMS Web site at: http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html.
In this final rule with comment period, we are clarifying that the
supervision and other requirements of the regulation at Sec. 410.27
apply to facility services that are paid to hospitals under the OPPS
and to these same services when they are furnished in CAHs and paid on
a reasonable cost basis. In OPPS hospitals, the requirements of Sec.
410.27 do not apply to professional services that are separately billed
under the MPFS or to PT, SLP, and OT services that are billed by the
hospital as therapy services and are paid at the applicable amount
based on the MPFS. The requirements of Sec. 410.27 also do not apply
to these same professional and PT, SLP, and OT services when they are
furnished in CAHs.
In OPPS hospitals, a small subset of ``sometimes therapy'' PT, SLP,
and OT services are paid under the OPPS when they are not furnished as
therapy, meaning not under a certified therapy plan of care. Because
the supervision and other conditions of payment under Sec. 410.27
apply to this subset of ``sometimes therapy'' services when they are
furnished in OPPS hospitals as nontherapy services (because they are
paid under the OPPS and not based on the MPFS), those conditions of
payment also apply to this subset of ``sometimes therapy'' services
when they are furnished as nontherapy in CAHs. When OPPS hospitals and
CAHs furnish these services as therapy services (under a therapy plan
of care by a qualified therapist), the conditions of payment under
Sec. 410.27 do not apply because
[[Page 68425]]
OPPS hospitals are paid for these services based on the MPFS and not
under the OPPS. As we did in the CY 2013 OPPS/ASC proposed rule, we are
providing a list of the ``sometimes therapy'' services that may be paid
under the OPPS in Table 46 below.
BILLING CODE 4120-20-P
[GRAPHIC] [TIFF OMITTED] TR15NO12.070
B. Enforcement Instruction for the Supervision of Outpatient
Therapeutic Services in CAHs and Certain Small Rural Hospitals
As we indicated in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74371), we extended through CY 2012 the notice of
nonenforcement of the requirement for direct supervision of outpatient
therapeutic services furnished in CAHs and small rural hospitals having
100 or fewer beds (available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html?redirect=/HospitalOutpatientPPS/01_
overview.asp). We extended this enforcement instruction to our
contractors for another year, through CY 2012, to allow time for the
initiation of supervision reviews by the Advisory Panel on Hospital
Outpatient Payment (the Panel), which began in early 2012 and are
continuing in accordance with the provisions of the CY 2012 OPPS/ASC
final rule with comment period.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45154), we requested
that CAHs and small rural hospitals submit to CMS for potential
evaluation by the Panel at its summer meeting any services for which
they anticipate difficulty complying with the direct supervision
standard in CY 2013. We stated that, in developing evaluation requests,
hospitals should refer to the evaluation criteria that we finalized in
the CY 2012 OPPS/ASC final rule with comment period. In order to give
hospitals additional opportunity during CY 2012 to become familiar with
the new submission and review process at the summer Panel meeting, and
to allow hospitals time to meet the required supervision levels for the
services that would be considered for CY 2013, we indicated that we
anticipated extending the nonenforcement instruction one
[[Page 68426]]
additional year through CY 2013. We stated that we expect that CY 2013
will be the final year for the instruction, regardless of the services
reviewed by the Panel during its summer meeting.
Comment: Most commenters supported an extension of the enforcement
instruction another year through CY 2013, and reiterated requests made
in previous years that we limit CAHs to the requirements in their
staffing Conditions of Participation (CoPs) by making the definition of
``direct supervision'' in Sec. 410.27 consistent with the CAH staffing
CoPs. These CoPs require that a doctor of medicine or osteopathy, nurse
practitioner, clinical nurse specialist, or physician assistant be
available to furnish patient care services at all times the CAH
operates (Sec. 485.631) and be available on site within 30 minutes
(Sec. 485.618). They apply to all services that are furnished by a
CAH. In contrast, for payment of most outpatient therapeutic services,
under Sec. 410.27 the CAH (like all OPPS hospitals) must furnish
direct supervision, meaning the supervising physician or appropriate
nonphysician practitioner is immediately available to furnish
assistance and direction for the duration of the service. The
requirement in Sec. 410.27 does not apply to CAH inpatient services or
to CAH outpatient diagnostic services.) Some commenters similarly
requested that CMS require only general supervision in CAHs and small
rural hospitals, meaning the services would be furnished under the
supervising physician's or appropriate nonphysician practitioner's
overall direction and control but he or she need not be physically
present.
One commenter stated that while the commenter understands the need
to allow CAHs and small rural hospitals to become compliant with the
recent clarifications regarding the outpatient supervision
requirements, and while the commenter shares the concerns of these
facilities regarding the available supply of certain types of
physicians, the supervision requirements should be applied uniformly
across all care settings for reasons of patient safety. In addition,
several commenters offered suggestions for improving the subregulatory
supervision review process.
Response: We appreciate the suggestions for improving the
supervision review process and will take them into consideration for
future Panel meetings. Regarding the supervision requirements for
payment of hospital and CAH outpatient services, we previously
discussed in the CY 2012 OPPS/ASC final rule with comment period (76 FR
74362) that the Act applies the same regulations to hospitals and CAHs
when appropriate (CAHs are included if ``the context otherwise
requires'' under section 1861(e) of the Act). As we indicated in the CY
2011 OPPS/ASC final rule with comment period (75 FR 72000 through
72005), we elected not to limit the CAHs to their CoPs or to exclude
them from the direct supervision requirement for payment because we
believe that Medicare should purchase outpatient services from CAHs and
other hospitals that are of the same basic level of safety and quality.
In addition, while CoPs apply to all services that a hospital or a CAH
furnishes, the payment rule in Sec. 410.27 applies only to outpatient
therapeutic services.
Regarding the enforcement instruction, as we discussed in the CY
2013 OPPS/ASC proposed rule, we will extend the enforcement instruction
one additional year through CY 2013. This additional year, which we
expect to be the final year of the extension, will provide additional
opportunities for stakeholders to bring their issues to the Panel, and
for the Panel to evaluate and provide us with recommendations on those
issues.
The Panel held its second meeting on supervision levels for
outpatient therapeutic services in August 2012, and considered several
stakeholder requests for a reduction in the minimum required level of
supervision for certain services. These included observation services;
administration of certain drugs and agents; and selected bladder, skin/
wound care, injection/infusion, intravenous and central venous access
services. In accordance with the subregulatory review process finalized
in the CY 2012 OPPS/ASC final rule with comment period, we are
currently reviewing public comments on the agency's preliminary
decisions regarding supervision levels for these services based upon
the Panel's recommendations. We will issue our final decisions on these
services prior to January 1, 2013 on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
XI. Outpatient Status: Solicitation of Public Comments in the CY 2013
OPPS/ASC Proposed Rule
A. Background
Under section 402(a)(1)(A) of the Social Security Amendments of
1967 (Pub. L. 90-248), the Secretary is permitted to engage in
demonstration projects to determine whether changes in the methods of
payment for health care and services under the Medicare program would
increase the efficiency and economy of those services through the
creation of incentives to those ends without adversely affecting the
quality of such services. Under this statutory authority, CMS has
implemented the Medicare Part A to Part B Rebilling (AB Rebilling)
Demonstration, which allows participating hospitals to receive 90
percent of the allowable Part B payment for Part A short-stay claims
that are denied on the basis that the inpatient admission was not
reasonable and necessary. Participating hospitals can rebill these
denied Part A claims under Part B and be paid for additional Part B
services than would usually be payable when an inpatient admission is
deemed not reasonable and necessary. This demonstration is slated to
last for 3 years, from CY 2012 through CY 2014.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45155 through 45157),
we provided an update of the status of the demonstration. In addition,
we solicited public comments on a related issue: potential policy
changes we could make to improve clarity and consensus among providers,
Medicare, and other stakeholders regarding the relationship between
admission decisions and appropriate Medicare payment, such as when a
Medicare beneficiary is appropriately admitted to the hospital as an
inpatient and the cost to hospitals associated with making this
decision.
In the proposed rule, we discussed that when a Medicare beneficiary
arrives at a hospital in need of medical or surgical care, the
physician or other qualified practitioner must decide whether to admit
the beneficiary for inpatient care or treat him or her as an
outpatient. In some cases, when the physician admits the beneficiary
and the hospital provides inpatient care, a Medicare claims review
contractor, such as the Medicare Administrative Contractor (MAC), the
Recovery Audit Contractor (RAC), or the Comprehensive Error Rate
Testing (CERT) Contractor, determines that inpatient care was not
reasonable and necessary under section 1862(a)(1)(A) of the Act and
denies the hospital inpatient claim for payment. In these cases, under
Medicare's longstanding policy, hospitals may rebill a separate
inpatient claim for only a limited set of Part B services, referred to
as ``Inpatient Part B'' or ``Part B Only'' services (Section 10,
Chapter 6 of the Medicare Benefit Policy Manual (Pub. 100-02)). The
hospital also may bill Medicare Part B for any outpatient services that
were provided in the 3-day payment window prior to the admission
(Section 10.12, Chapter 4 of the Medicare Claims Processing Manual
[[Page 68427]]
(Pub. 100-04)). These claims are subject to the timely filing
restrictions.
Once a Medicare beneficiary is discharged from the hospital, the
hospital cannot change the beneficiary's patient status from inpatient
to outpatient and then submit an outpatient claim because of the
potentially significant impact on beneficiary liability. As we discuss
below, hospital inpatients have significantly different Medicare
benefits and liabilities than hospital outpatients, notably coverage of
self-administered drugs and, for patients who are admitted to the
hospital as inpatients for 3 or more consecutive calendar days,
Medicare coverage of postacute SNF care (to the extent all other SNF
coverage requirements are met). To enable beneficiaries to make
informed financial and other decisions prior to hospital discharge,
Medicare allows the hospital to change a beneficiary's inpatient status
to outpatient (using condition code 44 on an outpatient claim) and bill
all medically necessary services that it provided to Part B as
outpatient services, but only if the change in patient status is made
prior to discharge, the hospital has not submitted a Medicare claim for
the admission, and both the practitioner responsible for the care of
the patient and the utilization review committee concur with the
decision (Section 50.3, Chapter 1 of the Medicare Claims Processing
Manual (Pub. 100-04); MLN Matters article SE0622, Clarification of
Medicare Payment Policy When Inpatient Admission Is Determined Not To
Be Medically Necessary, Including the Use of Condition Code 44:
``Inpatient Admission Changed to Outpatient,'' September 2004).
Medicare beneficiaries are provided with similar protections, which are
outlined in the Hospital Conditions of Participation (CoPs). For
example, in accordance with 42 CFR 482.13(b), Medicare beneficiaries
have the right to participate in the development and implementation of
their plan of care and treatment, to make informed decisions, and to
accept or refuse treatment. Informed discharge planning between the
patient and the physician is important for patient autonomy and for
achieving efficient outcomes.
In the proposed rule, we stated that while the limited scope of
allowed rebilling for ``Inpatient Part B'' services protects Medicare
beneficiaries and provides disincentives for hospitals to admit
patients inappropriately, hospitals have expressed concern that this
policy provides inadequate payment for resources that they have
expended to take care of the beneficiary in need of medically necessary
hospital care, although not necessarily at the level of inpatient care.
A significant proportion of the Medicare CERT error rate consists of
short (1- or 2-day) stays where the beneficiary received medically
necessary services that the CERT contractor determined should have been
provided as outpatient services and not as inpatient services.
Hospitals have indicated that often they do not have the necessary
staff (for example, utilization review (UR) staff or case managers) on
hand after normal business hours to confirm the physician's decision to
admit the beneficiary. Thus, for a short-stay admission, the hospital
may be unable to timely review and change a beneficiary's patient
status from inpatient to outpatient prior to discharge in accordance
with the condition code 44 requirements.
In the proposed rule, we indicated that we have heard from various
stakeholders that hospitals appear to be responding to the financial
risk of admitting Medicare beneficiaries for inpatient stays that may
later be denied upon contractor review by electing to treat
beneficiaries as outpatients receiving observation services, often for
longer periods of time, rather than admitting them as inpatients. In
recent years, the number of cases of Medicare beneficiaries receiving
observation services for more than 48 hours, while still small, has
increased from approximately 3 percent in 2006 to approximately 7.5
percent in 2010. This trend is concerning because of its effect on
Medicare beneficiaries. There could be significant financial
implications for Medicare beneficiaries of being treated as outpatients
rather than being admitted as inpatients, of which CMS has informed
beneficiaries.\1\ For instance, if a beneficiary is admitted as an
inpatient, the beneficiary pays a one-time deductible for all hospital
services provided during the first 60 days in the hospital. As a
hospital inpatient, the beneficiary would not pay for self-administered
drugs or have any copayments for the first 60 days; whereas if the
beneficiary is treated as an outpatient, the beneficiary has a
copayment for each individual outpatient hospital service received.
While the Medicare copayment for a single outpatient hospital service
cannot be more than the inpatient hospital deductible, the
beneficiary's total copayment for all outpatient services received may
be more than the inpatient hospital deductible. In addition, usually
self-administered drugs provided in an outpatient setting are not
covered by Medicare Part B and hospitals may charge the beneficiary for
them. Also, the time spent in the hospital as an outpatient is not
counted towards the 3-day qualifying inpatient stay that section
1861(i) of the Act requires for Medicare Part A coverage of postacute
care in a SNF.
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\1\ CMS Pamphlets: ``Are You a Hospital Inpatient or Outpatient?
If You Have Medicare--Ask!'', CMS Product No. 11435, Revised,
February 2011; ``How Medicare Covers Self-Administered Drugs Given
in Hospital Outpatient Settings,'' CMS Product No. 11333, Revised,
February 2011.
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As a result of these concerns related to the impact of extended
time as an outpatient on Medicare beneficiaries, the CERT error rate,
and the impact on hospitals of a later inpatient denial, CMS initiated
the AB Rebilling Demonstration for a 3-year period for hospitals. This
demonstration is voluntary and allows participating hospitals to rebill
outside of the usual timely filing requirements for services relating
to all inpatient short-stay claims that are denied for lack of medical
necessity because the inpatient admission was not medically necessary.
Under the demonstration, hospitals may receive 90 percent of the
Medicare allowable payment for all Part B services that would have been
medically necessary had the beneficiaries originally been treated as
outpatients and not admitted as inpatients. We note that hospitals
cannot rebill for observation services, which, by definition, must be
ordered prospectively to determine whether an inpatient admission is
necessary (Chapter 1, Section 50.3.2 of the Medicare Claims Processing
Manual (Pub. 100-04); FAQ 2723, available on the CMS Web site at
https://questions.cms.gov/faq.php?id=5005&faqId=2723). Hospitals that
participate in the AB Rebilling Demonstration will waive any appeal
rights associated with the denied inpatient claims eligible for
rebilling. Under the demonstration, Medicare beneficiaries are
protected from any adverse impacts of expanded rebilling. For example,
hospitals cannot bill beneficiaries for self-administered drugs or
additional cost-sharing that would be required under Medicare Part B.
The demonstration will inform us on the impact that expanded rebilling
may have on the Medicare Trust Funds, beneficiaries, hospitals, and the
CERT error rate. The demonstration is designed to evaluate potential
impacts of expanded rebilling on admission and utilization patterns,
including whether expanded rebilling would reduce hospitals' incentive
to make appropriate initial admission decisions.
Hospitals expressed significant interest in the AB Rebilling
[[Page 68428]]
Demonstration, which began on January 1, 2012. The demonstration was
approved to accept up to 380 hospitals. In order to participate in the
demonstration, a hospital must not be receiving periodic interim
payments from CMS, and must be a Medicare-participating hospital as
defined by section 1886(d) of the Act, a category that includes all
hospitals paid under the Medicare IPPS, but excludes hospitals paid
under the IPF PPS, the IRF PPS, and the LTCH PPS, and cancer hospitals,
CAHs, and children's hospitals.
The hospitals that volunteered to participate and were accepted in
the demonstration began rebilling in early spring of 2012. More
information about the demonstration is available on the CMS Web site
at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/CERT/Part_A_to_Part_B_Rebilling_Demonstration.html. We
stated in the proposed rule that we plan to conduct an evaluation of
the demonstration during and after its completion.
B. Summary of Public Comments Received
While we are implementing the AB Rebilling Demonstration, we also
solicited public comments in the CY 2013 OPPS/ASC proposed rule on
other actions that we could potentially undertake to address
stakeholders' concerns. In the proposed rule, we stated that there may
be several ways of approaching the multifaceted issues that have been
raised in recent months around a beneficiary's patient status and
Medicare hospital payment. Given the complexity of this topic, we
sought public perspectives on potential options the agency might adopt
to provide more clarity and consensus regarding patient status for
purposes of Medicare payment. We invited commenters to draw on their
knowledge of these issues to offer any suggestions that they believe
would be most helpful to them in addressing the current challenges,
while keeping in mind the various impacts in terms of recently observed
increases in the length of time for which patients receive observation
services, beneficiary liability, Medicare spending, and the feasibility
of implementation of any suggested changes for both the Medicare
program and hospitals.
We received approximately 350 public comments in response to our
solicitation in the CY 2013 OPPS/ASC proposed rule from hospitals and
hospital associations, physician associations, rehabilitative and long-
term care facilities, beneficiaries, beneficiary advocacy
organizations, Quality Improvement Organizations (QIOs), organizations
specializing in medical necessity review, and other interested parties.
The commenters provided significant input, and the majority requested
that CMS not implement a comprehensive solution or set of solutions
regarding patient status in the CY 2013 OPPS/ASC final rule with
comment period. Instead, many commenters recommended that CMS develop
an informed course of action in the upcoming months through a formal,
ongoing dialogue with all interested stakeholders (for example, through
open door forums or a task force). A few commenters recommended a more
immediate course of action to limit beneficiary liability for SNF care
and for the difference in beneficiary cost-sharing between hospital
inpatient and outpatient services.
In this section, we summarize the feedback we received in response
to our solicitation of public comments in the CY 2013 OPPS/ASC proposed
rule. We are not providing responses to the public comments we received
because in the proposed rule we strictly solicited public comments, and
did not propose any changes in policy. We will consider the feedback we
received from the public as we move forward. We structured our summary
of the public comments around key suggestions that we have heard from
stakeholders in the following areas: (1) Part A to Part B Rebilling;
(2) Clarifying Current Admission Instructions or Establishing Specified
Clinical Criteria; (3) Hospital Utilization Review; (4) Prior
Authorization; (5) Time-Based Criteria for Inpatient Admission; (6)
Payment Alignment; and (7) Public Comments on Other Topics (including
Rules for External Review of Inpatient Claims, Improving Beneficiary
Protections, and Revising the Qualifying Criteria for SNF Coverage). We
summarize the public comments below in the context of each of these
suggestions.
1. Part A to Part B Rebilling
Some stakeholders have suggested that, when a Part A inpatient
claim is denied because an inpatient level of care was not reasonable
and necessary although some medical care was necessary, CMS allow
hospitals to rebill Medicare and receive payment for all Part B
services that would have been payable had the patient originally been
treated as an outpatient rather than an inpatient. As we describe
above, the AB Rebilling Demonstration allows participating providers to
receive 90 percent of the allowable payment amount for such services
(except observation services) as Part B Inpatient services. Because
establishing such a policy on a national basis could result in
increases in Medicare expenditures and could affect beneficiary
liability for hospital care, CMS implemented the demonstration to
assess Medicare spending and other outcomes while protecting
beneficiaries from any increase in liability.
Comments: Commenters expressed some support for the AB Rebilling
Demonstration as an important step in determining what types of policy
clarifications are needed. The commenters noted that the beneficiary
protections against changes in liability are a key benefit of the
demonstration. While some commenters expressed appreciation for the
opportunity for increased Part B payment to hospitals, they disagreed
with the demonstration's requirement to forego appeals of the denied
inpatient claims eligible for rebilling. One commenter requested that
CMS provide interim reports to stakeholders describing the
demonstration's evaluation criteria and its progress towards meeting
its goals.
Some commenters recommended that CMS establish a national policy
allowing the rebilling of all Part B services that would have been
payable if the patient had been treated as an outpatient rather than
admitted as an inpatient because, according to the commenters,
outpatient and inpatient services are sometimes indistinguishable. The
commenters believed that the Medicare statute does not preclude such a
policy and that, due to the recent focus on claims audit and review,
hospitals would have no incentive to admit beneficiaries
inappropriately in response to a more generous rebilling policy.
However, other commenters expressed concern that there would be such an
incentive. They indicated that allowing expanded rebilling with a
change in bill type from a Part A claim to a Part B claim would remove
the incentive to bill accurately, as hospitals would file more
inpatient claims under Part A in order to receive the (typically
higher) Diagnosis-Related Group (DRG) payment under the IPPS, knowing
that, in the event of the inpatient claim being denied, they could
rebill under Part B and receive the same (typically lower) OPPS payment
they would have received if they had billed an outpatient claim
initially.
Several commenters suggested that allowing full Part B rebilling
would negate and undermine the designs of the OPPS and the IPPS. The
commenters stated that OPPS payments are established to compensate
hospitals for the care provided in the outpatient setting, and that
they act as a natural
[[Page 68429]]
complement to the IPPS. They indicated that making the two payment
systems retroactively interchangeable would result in the payment rates
calculated under each system being miscalibrated and failing to adjust
appropriately over time to migration of services from the inpatient to
the outpatient setting. In addition, according to the commenters, a
national policy allowing full Part B rebilling would provide an unfair
market advantage to providers who make inappropriate inpatient
admission determinations over those who do not. The commenters reasoned
that Medicare's current policies are well-founded, longstanding, widely
known and largely followed, and that the current challenges do not
warrant the extensive resources that full rebilling and other policy
changes would entail.
Some commenters indicated that a national policy allowing full Part
B rebilling following the denial of an inpatient claim would have
limited utility because typically the timely filing period has lapsed
by the time the inpatient claim is denied, providers could not appeal
the inpatient claim, and providers would not receive the Part A payment
that they seek. In addition, according to the commenters, the manual
process of recoding the inpatient claim as an outpatient claim is
costly. A few commenters suggested that CMS allow rebilling of all Part
B services but apply a penalty by limiting payment to a discounted
amount. Other commenters were concerned about the significant financial
burden of Part B rebilling for beneficiaries who have Part A coverage
but do not have coverage for Part B services.
Some commenters also suggested that CMS allow hospitals to change a
beneficiary's inpatient status to outpatient after discharge in order
to submit a Part B outpatient claim either prior to or after submitting
an inpatient claim. Other commenters recommended that CMS extend the
timely filing deadline to 1 year from the date of service or 6 months
to 1 year from the date of the inpatient claim denial, whichever is
later. Some commenters suggested that CMS extend the timely filing
deadline only for claims that are denied after a significant amount of
time has passed since the date of service.
Commenters suggested mechanisms to protect beneficiaries from
increases in their liability associated with any of these policy
changes. For example, several commenters believed that hospitals could
waive any increases in beneficiary cost-sharing or that CMS could
provide coverage for self-administered drugs in the outpatient
department, cap the sum of outpatient services at the inpatient
deductible, or establish annual maximum out-of-pocket costs. Many
commenters also recommended the modernization and reform of the SNF
qualification criteria (we describe these comments further below).
2. Clarifying Current Admission Instructions or Establishing Specified
Clinical Criteria
In recent months, we have heard from some stakeholders who
suggested a need for us to clarify our current instructions regarding
the circumstances under which Medicare will pay for an admission in
order to improve hospitals' ability to make appropriate admission
decisions. Stakeholders have suggested the establishment of more
specific clinical criteria for admission and payment such as adopting
specific clinical measures because, according to the commenters, the
current criteria are not clear-cut. We have issued longstanding
instructions that the need for admission is a complex medical judgment
that depends upon multiple factors, including an expectation that the
beneficiary will require an overnight stay in the hospital or need more
than 24 hours of care, the patient's medical history and current
medical needs, the types of facilities available to inpatients and to
outpatients, the hospital's policies, the relative appropriateness of
outpatient and inpatient treatment, and other factors (Section 10,
Chapter 1 of the Medicare Benefit Policy Manual (Pub. 100-02)). We
stated in the CY 2013 OPPS/ASC proposed rule that we are interested in
receiving public comments and suggestions regarding whether and how we
might improve our current instructions and clarify the application of
Medicare payment policies for both hospitals and physicians, keeping in
mind the challenges of implementing national standards that are broad
enough to contemplate the range of clinical scenarios but prescriptive
enough to provide greater clarity.
Comments: The public comments reflected a widespread understanding
and agreement with CMS' guidance that the inpatient admission decision
is ultimately a complex medical judgment that involves the
consideration of many factors. Many commenters indicated that if
Medicare adopted more specific guidelines or criteria, the clinical
judgment of the treating physician should have primacy. A recurrent
comment was that this judgment would always be necessary in certain
cases, and should take precedence over other criteria that may be used.
Many commenters were concerned that decision-making tools (such as
Interqual Clinical Decision Support or the Milliman Care Guidelines,
alternatively described by commenters as commercial or proprietary
screening tools), which are designed for use as guidelines rather than
prescriptive tools, do not take into account patient ``risk'' and may
undermine the physician's judgment.
In addition, many commenters believed that any selected criteria
must apply equally to Medicare contractors, hospitals, and others and
should match the audit review criteria. Many commenters expressed
concern that Medicare's claims review contractors inappropriately
disregard the physician's judgment, and do not employ a physician in
making their determinations. (We describe the comments on external
review criteria in further detail below). One commenter indicated that
commercial screening tools do not always comport with Medicare rules.
The commenter provided as an example that one popular tool fails to
distinguish scheduled replacement pacemaker procedures from the
placement of a new pacemaker on an emergency basis. Some of the public
comments received from physicians identified what they characterized as
significant problems with the accuracy, validity, and transparency of
proprietary screening tools, including use of appropriateness standards
that are not accepted by the relevant physician specialties and failure
to follow Medicare payment policy.
Nevertheless, many commenters expressed support for various types
of national criteria. These criteria included evidence-based guidelines
such as the Agency for Healthcare Research and Quality's National
Clearinghouse Guidelines or other rules developed in consultation with
physician societies. Some commenters supported the use of specific
proprietary screening tools such as Interqual Clinical Decision Support
or the Milliman Care Guidelines. Other commenters favored more
transparent criteria similar to the Correct Coding Initiative (CCI)
that are adapted for Medicare and are developed using physician input.
One commenter indicated that the CCI edits have proven more cost-
effective than proprietary tools. A few commenters suggested that use
of the Program for Evaluating Payment Patterns Electronic Report
(PEPPER) reports, which provide hospital-specific Medicare data
statistics for discharges that are vulnerable to improper payments,
would allow for continuous improvement in utilization and coding. One
commenter noted that it would be useful to choose the set of
[[Page 68430]]
criteria that are used by Medicaid and other payers, in order to
facilitate uniform documentation that supports the specific criteria
required by the various screening tools.
Some commenters pointed out process improvements that hospitals and
physicians should make, regardless of whether CMS adopts specific
clinical criteria or issues more specific admission instructions.
Several commenters stated that physicians should improve their
documentation in support of the patient status that they order, and
that sometimes it is not clear whether the physician ordered inpatient
admission or outpatient observation services. The commenters suggested
that physicians document the need for admission in a standardized field
on electronic health records or elsewhere. Other commenters emphasized
the importance of the role of the hospital in selecting patient status
for purposes of billing because they believed that the physician is
focused on ordering the necessary care and, for good reason according
to the commenters, is not occupied with the nuances of patient status
designation for payment purposes.
3. Hospital Utilization Review
In the proposed rule, we asked commenters to consider the
responsibility of hospitals to utilize all of the tools necessary to
make appropriate initial admission decisions. We stated that we believe
this is important because some hospitals have indicated that simply
having case management and UR staff available to assist in decision-
making outside of regular business hours may improve the accuracy of
admission decisions.
Comments: Several commenters stated that some hospitals do not have
UR staff on hand outside normal business hours or on weekends to assist
with patient status determinations, and that this is especially
problematic for patients with short inpatient stays. The commenters
expressed varying opinions on hospital UR. Some commenters recognized
that Medicare's regulations require the collaboration of the treating
physician and the hospital's UR staff in making the appropriate patient
status determination, and believed that neither party is dispensable.
Several commenters indicated that 24-hour, 7 days a week availability
of hospital UR and/or case management staff should be a hospital best
practice, as it assists in making appropriate admission determinations
for short-stay cases where the need for admission is unclear. Several
commenters opined that Medicare should require the availability of
hospital UR on a 24-hour/7 days a week basis. One commenter stated that
CMS should develop a certification process of ``deeming'' acceptable
individual hospital UR processes, using a standard of 24-hour/7 days a
week availability, confirmation by an external physician, and adherence
to the hospital CoPs. Another commenter recommended the use of a
condition code on claims to track whether UR confirmation of
appropriate patient status is associated with fewer claim denials. Some
commenters preferred reinforcement of hospital UR over the institution
of external guidelines for admission.
However, several commenters indicated that Medicare's current UR
requirements in the CoPs should be eliminated because of the
administrative cost to the hospital, or because they do not result in
more accurate admission determinations that are commensurate with their
associated cost. One association believed that hospital UR will have
limited utility as long as admission criteria are unclear. Yet another
physician professional association stated that hospitals should be
required to submit their claims based on the admitting physician's
judgment rather than the opinion of another physician in the hospital.
4. Prior Authorization
In our proposed rule, we also invited public comments on the
potential use of prior authorization for payment of a hospital
inpatient admission.
Comments: Many commenters believed that the concept of using prior
authorization on a targeted basis was promising and worthy of
consideration. To facilitate administrative feasibility, many
commenters suggested that it be used selectively for elective
procedures, specific services that are not designated as inpatient-only
services under the OPPS, or conditions that are at high-risk for
inappropriate inpatient admission. The commenters were concerned that
mandatory prior authorization could become a barrier to the provision
of urgent care, and some recommended that CMS exclude patients in the
emergency department or those receiving critical care. Alternatively,
the commenters suggested that prior authorization be used as an adjunct
method for cases not meeting the admission criteria of commercial
screening tools.
Several commenters believed that prior authorization is feasible
because hospitals already have an infrastructure for obtaining prior
authorization for commercial insurers. The commenters suggested that
CMS could similarly redirect current resources towards a prior
authorization program. Several commenters suggested an online tool for
prior authorization.
A few commenters opposed prior authorization altogether based on
administrative burden, and many commenters believed that it would need
to result in guaranteed payment in order to be useful. One commenter
observed that retrospective review is still required in many cases when
prior authorizations are obtained from commercial insurers, due to
incomplete or inaccurate prior authorization information and changes in
what was planned or expected when the initial clinical information was
submitted. The commenter stated that for this reason, commercial
insurers reserve the right to perform, and often do perform,
retrospective audits based on the completed medical record. In
addition, the commenter stated that the CERT error rate evidences that
the vast majority of providers understand and follow the current
Medicare statutes and rules. Thus, according to the commenter,
requiring prior authorization will add significant cost to the program
without eliminating the inpatient error rate, at a time when the
Medicare Trust Fund is at risk.
5. Time-Based Criteria for Inpatient Admission
In the proposed rule, we stated that some stakeholders have
suggested that CMS has authority to define whether a patient is an
inpatient or an outpatient. They believed that it may be permissible
and appropriate for us to redefine ``inpatient'' using parameters in
addition to medical necessity and a physician order that we currently
use, such as length of stay (LOS) or other variables. For example,
currently a beneficiary's anticipated LOS at the hospital may be a
factor in determining whether the beneficiary should be admitted to the
hospital, but is not the only factor. We have issued instructions that
state that, typically, the decision to admit should be made within 24
to 48 hours, and that expectation of an overnight stay may be a factor
in the admission decision (Section 20.6, Chapter 6 and Section 10,
Chapter 1 of the Medicare Benefit Policy Manual (Pub. 100-02)).
However, we stated in the proposed rule that we are interested in
hearing from stakeholders regarding whether it may be appropriate and
useful to establish a point in time after which the encounter becomes
an inpatient stay if the beneficiary is still receiving medically
necessary care to treat or evaluate his or her condition. We indicated
that such a policy could
[[Page 68431]]
potentially limit the amount of time that a beneficiary is treated as
an outpatient receiving observation services before the hospital
encounter becomes inpatient, provided the additional time in the
hospital is medically necessary. Currently, we do not specify a limit
on the time a beneficiary may be an outpatient receiving observation
services, although, in the past, we have limited payment of observation
services to a specific timeframe, such as 24 or 48 hours. Some in the
hospital community have indicated that it may be helpful for the agency
to establish more specific criteria for patient status in terms of how
many hours the beneficiary is in the hospital, or to provide a limit on
how long a beneficiary receives observation services as an outpatient.
We invited public comments regarding whether there would be more
clarity regarding patient status under such alternative approaches to
defining inpatient status. We also noted that it is important for CMS
to maintain its ability to audit and otherwise carry out its statutory
obligation to ensure that the Medicare program pays only for reasonable
and necessary care. We asked that commenters consider opportunities for
inappropriately taking advantage of the Medicare system that time-based
and other changes in criteria for patient status may create.
Comments: Some commenters expressed interest and support for
criteria that are strictly time-based, based largely on a primary goal
of eliminating extended observation cases. These commenters supported
defining a patient as an inpatient after 24, 48, or 72 hours, and noted
that such a policy could improve the problem of beneficiaries not
qualifying for needed SNF care due to their outpatient status. One
commenter believed that a 48-hour benchmark made sense because it is
consistent with the activities that are required under the CoPs within
the first 48 hours of a hospital stay. Another commenter suggested
establishing a second decision point during the observation period,
when the physician must reevaluate whether the patient needs to be
admitted as an inpatient. However, the commenter noted that this may
increase administrative complexity without commensurate benefit.
Some commenters representing the hospital community believed that
patients who have been actively monitored for more than 24 to 48 hours
as outpatients under observation and cannot be safely discharged are
likely sufficiently complex cases that would benefit from being
admitted as an inpatient, regardless of whether they technically meet
inpatient admission criteria. The commenters posited that observation
services are more comparable to inpatient care than they are to other
outpatient services, and that this fact would be more accurately
reflected by a time-based admission policy. A few commenters suggested
that CMS limit observation care to 24 hours, with exceptions for
physician discretion. Several commenters suggested that CMS clarify the
definition and parameters of outpatient observation services to help
stakeholders determine when it is appropriate to furnish observation
services and for how long. Another commenter suggested that CMS limit a
patient's time in observation by requiring additional assessments and
increased documentation of involvement by the physician.
In contrast, many commenters expressed reservations about a time-
based approach. Some commenters posited that inpatient and outpatient
services are different in nature. One physician association stated that
the primary difference between the inpatient and outpatient setting is
the availability of nurses (and related staff) and advanced technology
in the inpatient setting, which accounts for the added cost of
inpatient care. The commenter recommended structuring an inpatient DRG
payment around short-stay admissions where the physician believes that
these added components of care are necessary. Other commenters were
concerned that under a time-based policy, the level of service would no
longer be taken into account in hospital payment and that such a policy
would inappropriately negate the need for medical necessity review.
Some commenters stated that the medical review would simply shift to
assessing the necessity of the patient's LOS as an outpatient or
whether the patient needed continuing hospital care at the time they
became an inpatient. Some commenters believed that a time-based policy
would result in additional short inpatient stays than under current
Medicare guidance. Therefore, these commenters believed that hospitals
would continue to be subject to audit risk and that short-stay audits
would simply increase.
Another commenter expressed concern that hospitals may be
substituting outpatient observation services for inpatient admissions
in order to maximize their outpatient drug revenues under the Federal
340B Drug Pricing Program. The commenter recommended that CMS modify
the definitions of ``outpatient'' and ``inpatient'' to explicitly
clarify that a patient's status determination should be based solely on
appropriate clinical judgment, and should not be influenced by
financial motives under programs such as the 340B Drug Pricing Program.
Some commenters opposed time-based rules because, according to the
commenters, it would undermine the judgment of the treating physician.
Other commenters noted that the absence of objective clinical criteria
for choosing a timeframe would render time-based criteria for admission
arbitrary. Several commenters opposed limiting observation services to
24 hours because hospitals often need more time (particularly up to 48
hours) to evaluate diagnostic testing and develop the right treatment
plan. They noted that practice patterns vary widely nationally and
among facilities in the same region. Other commenters were concerned
that a policy of never counting certain days as inpatient days could
actually reduce beneficiary access to SNF care. Other commenters
believed that a time-based policy would need refinement around issues
like requirement of a physician order for inpatient admission.
Several commenters opposed time-based criteria because such
criteria may conflict with the provision of inpatient surgical care for
patients who require only short admissions. The commenters pointed out
that such a policy could conflict with Medicare's inpatient only list,
and that as the standard of practice evolves to enable longer inpatient
services to be furnished during short (1- or 2-day) inpatient stays,
those services would no longer qualify as inpatient services. One
commenter stated that there are some procedures that are so inherently
complex that they may be performed only on an inpatient basis,
regardless of how long (or short) the time was that the patient spent
in the hospital. The commenter stated that establishing a bright-line
time rule could create a situation whereby these services could be
denied solely on the basis of the time spent in the hospital while
ignoring the level of service required for subjecting a patient to an
inherently risky procedure. The commenter expressed concern that CMS
might require that all patients, regardless of clinical presentation,
first undergo a period of 48 hours of observation before being admitted
as inpatients to the hospital, despite the fact that their medical
condition and treatment plan may be wholly consistent with an inpatient
admission upon presentation to the hospital.
Several commenters recommended that rather than limiting the
timeframe for observation services, observation care should be
furnished in dedicated observation units in emergency
[[Page 68432]]
departments rather than on floor units. They cited studies showing that
the dedicated units save costs compared to inpatient care and
demonstrate shorter timeframes than the floor units for diagnosing or
discharging.
6. Payment Alignment
In the proposed rule, we asked commenters to consider how aligning
payment rates more closely with the resources expended by a hospital
when providing outpatient care versus inpatient care of short duration
might reduce payment disparities and influence financial incentives and
disincentives to admit.
Comments: Commenters expressed significant interest in various
means of improving the alignment of payment for what they termed
equivalent outpatient and short inpatient hospital stays. Most of the
commenters who supported payment alignment suggested developing a DRG
for short inpatient stays, although several commenters recommended an
expanded outpatient APC payment in addition to or in lieu of a short-
stay DRG. Some commenters suggested basing the payment for short-stay
inpatient admissions on a percentage of the related DRG by mean LOS.
For example, if the mean LOS for a given DRG is 3 days, then the
hospital would be paid one-third of that DRG for an inpatient admission
with a 1-day stay. Several commenters suggested a short-stay outlier
policy similar to the LTCH PPS, or a policy similar to the IPPS
transfer policy. Other commenters more broadly suggested developing a
resource-based payment structure specifically for short-stay, lower
acuity admissions.
Some commenters noted, however, that aligning payment rates would
reduce but not eliminate the financial risk of claim denial. According
to the commenters, a payment alignment approach would not eliminate the
potential for continued use of observation care over inpatient
admission. One commenter asserted that the resources expended by a
hospital for inpatient and outpatient care are already aligned when the
care is billed appropriately.
7. Public Comments on Other Topics
We received a number of public comments on other related issues.
a. Rules for the External Review of Inpatient Claims
Comments: Many commenters expressed concerns about the criteria
that are used by Medicare's contractors to determine the medical
necessity of hospital inpatient admissions. The commenters were
concerned that the review criteria being utilized by contractors do not
match the admission criteria set forth in Medicare's guidance. In
particular, according to the commenters, contractors are not employing
physicians in making their medical necessity determinations, even
though Medicare instructs that the admission decision is a complex
medical judgment that involves forecasting a potential (not definite)
need for an overnight stay or more than 24 hours of hospital care, or
the risk of harm to the patient if not admitted (predictability of an
adverse event). The commenters asserted that, as a result, claims
reviewers inappropriately base their judgment on information that was
not predictable or available to the physician at the time of admission.
Many commenters recommended that CMS increase its oversight of the
Agency's medical review contractors, and ensure that its review rules
are being followed. Commenters asked that CMS require all review
contractors to use the same criteria to determine medical necessity
that physicians and hospitals are required to use in making the
inpatient admission decision; to use a physician reviewer in accordance
with the QIO claim review standard, or to consult with the treating
physician or a physician in the same specialty as the admitting
physician; and to provide justification to the treating physician in
support of a claim denial. According to the commenters, the review
criteria that are used should apply uniformly to Medicare contractors,
hospitals, and others.
Several commenters indicated that physician payment for
professional services should be denied whenever inpatient hospital
payment is denied, due to the role of the physician in the admission
decision. In contrast, some physician commenters were concerned that
they already are often inappropriately at risk for denial of their Part
B claim when a hospital inpatient claim is denied, or when a hospital
changes a patient's status to outpatient without their knowledge such
that the place of service on the physician claim does not match that
claimed by the hospital. They stated that, in some cases, the hospital
does not bill Medicare, so there is no companion claim at all.
Similarly, some physicians expressed concern that hospitals use ``black
box'' proprietary tools to identify allegedly inappropriate admissions
and change the patient's status to outpatient without the knowledge of
the patient or the physician. These commenters also expressed concern
for any adverse impact on beneficiary liability.
b. Improving Beneficiary Protections
Comments: Many commenters suggested means of improving beneficiary
protections against unforeseen changes in his or her liability. These
included providing Medicare coverage for self-administered drugs in the
hospital outpatient department, waiving beneficiary coinsurance,
capping the sum of outpatient services at the inpatient deductible, or
establishing annual maximum out-of-pocket costs. Some commenters
suggested that Medicare clarify and strengthen beneficiary notification
and appeal rights regarding changes in patient status and the receipt
of observation care. For example, according to the commenters, Medicare
should require a straightforward explanation to beneficiaries of the
cost-sharing implications of being an outpatient receiving observation
services compared to being an inpatient. One QIO noted that as part of
their case review activities, QIOs review beneficiary appeals of
inpatient hospital discharges to assure that patients are medically
ready to move to the next level of care. The QIO believed that if a
beneficiary receives only outpatient observation services and is not an
inpatient, he or she has no right to appeal his or her discharge from
the hospital to the QIO. The QIO stated that it often receives
complaints from beneficiaries who believe they are being discharged
prematurely, only to find out that the QIO cannot review that care
because the hospital classified the stay as observation rather than
inpatient.
Some commenters suggested means of penalizing hospitals for
inappropriate admission patterns. They provided examples such as
developing quality measures with payment penalties to identify
instances of inappropriate use of observation care for patients meeting
inpatient admission criteria, or counting time spent receiving
observation services as inpatient time for the purposes of hospital
readmission penalties. Other commenters recommended improving physician
education regarding the beneficiary liabilities that are associated
with patient status to facilitate patient status determinations that
take beneficiary cost-sharing into account.
c. Revising the Qualifying Criteria for Skilled Nursing Facility (SNF)
Coverage
Comments: Many commenters recommended that Congress and/or CMS
modernize and revise the SNF qualification rules. Many beneficiaries,
beneficiary representatives, SNFs, and others requested that CMS count
the
[[Page 68433]]
time a beneficiary spends as an outpatient receiving observation
services towards the 3-day hospital inpatient stay that is required for
coverage of SNF care. Many commenters indicated that the statutory
time-based rule that requires a beneficiary to have a 3-day inpatient
hospital stay in order to qualify for SNF care is obsolete, given the
advances in medical care, the trend towards reduced LOS, and the
migration of services from inpatient to outpatient over the course of
the Medicare program's history. These commenters recommended that this
rule be replaced with clinically meaningful criteria that are not time-
based or based on patient status.
A few commenters asserted that CMS could use its statutory
authority under section 1812(f) of the Act (as enacted by section 123
of the Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. 97-
248) to waive the 3-day qualification rule. Some commenters asserted
that the criteria for using this authority would be met, namely that
there would be no increase in associated costs to the Medicare program
and that the acute nature of the SNF benefit would be maintained. The
Act provides that the Secretary shall provide for coverage of extended
care services which are not post-hospital extended care services at
such time and for so long as the Secretary determines that the
inclusion of such services will not result in any increase in the total
payments made under Title XVIII, and will not alter the acute care
nature of the SNF benefit. Other commenters believed that new statutory
authority would be required to change the SNF criteria, and they
expressed their support for bills they stated have been introduced in
the Congress to count time in observation as inpatient time for
purposes of SNF qualification. Some commenters recommended waiving the
3-day rule for certain diagnoses that benefit from short inpatient
stays and speedy access to postacute rehabilitative services. They
indicated that some beneficiaries require only a brief hospital
assessment, rather than a lengthy stay in acute care, prior to long-
term skilled care, and that it is not uncommon for patients with
hospital stays of less than 3 days to require follow up care in a SNF.
C. Summary
We appreciate all of the public comments that we received on this
multi-faceted topic. We will take all of the public comments that we
received into consideration as we consider future actions that we could
potentially undertake to provide more clarity and consensus regarding
patient status for purposes of Medicare payment.
XII. CY 2013 OPPS Payment Status and Comment Indicators
A. CY 2013 OPPS Payment Status Indicator Definitions
Payment status indicators (SIs) that we assign to HCPCS codes and
APCs play an important role in determining payment for services under
the OPPS. They indicate whether a service represented by a HCPCS code
is payable under the OPPS or another payment system and also whether
particular OPPS policies apply to the code. The CY 2013 status
indicator assignments for APCs and HCPCS codes are shown in Addendum A
and Addendum B, respectively, on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. We note that, in the past, a majority
of the Addenda referred to throughout the preamble of our OPPS/ASC
proposed and final rules appeared in the printed version of the Federal
Register as part of the annual rulemakings. However, beginning with the
CY 2012 OPPS/ASC proposed rule, the Addenda will no longer appear in
the printed version of the OPPS/ASC rules that are found in the Federal
Register. Instead, these Addenda will be published and available only
via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
We did not receive any public comments related to the definitions
of the OPPS status indicators, and therefore, as we proposed in the CY
2013 OPPS/ASC proposed rule (77 FR 45157), for CY 2013, we are not
making any changes to the definitions of status indicators that were
listed in Addendum D1 of the CY 2012 OPPS/ASC final rule with comment
period. We believe that these definitions of the OPPS status indicators
continue to be appropriate for CY 2013.
The complete list of the final CY 2013 status indicators and their
definitions is displayed in Addendum D1 on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
B. CY 2013 Comment Indicator Definitions
In the CY 2013 OPPS/ASC proposed rule (77 FR 45158), for the CY
2013 OPPS, we proposed to use the same two comment indicators that are
in effect for the CY 2012 OPPS.
``CH''--Active HCPCS codes in current and next calendar
year; status indicator and/or APC assignment have changed or active
HCPCS code that will be discontinued at the end of the current calendar
year.
``NI''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year as compared to current calendar year, interim APC
assignment; comments will be accepted on the interim APC assignment for
the new code.
We proposed to use the ``CH'' comment indicator in the CY 2013
OPPS/ASC proposed rule to indicate HCPCS codes for which the status
indicator or APC assignment, or both, are proposed for change in CY
2013 compared to their assignment as of June 30, 2012. We stated that
we believed that using the ``CH'' indicator in the CY 2013 OPPS/ASC
proposed rule would facilitate the public's review of the changes that
we were proposing for CY 2013. We stated that the use of the comment
indicator ``CH'' in association with a composite APC indicates that the
configuration of the composite APC is proposed to be changed in the CY
2013 OPPS/ASC final rule with comment period.
We proposed to use the ``CH'' comment indicator in the CY 2013
OPPS/ASC final rule with comment period to indicate HCPCS codes for
which the status indicator or APC assignment, or both, would change in
CY 2013 compared to their assignment as of December 31, 2012.
In addition, any existing HCPCS codes with substantial revisions to
the code descriptors for CY 2013 compared to the CY 2012 descriptors
are labeled with comment indicator ``NI'' in Addendum B to the CY 2013
OPPS/ASC final rule with comment period. However, as we stated in the
proposed rule, in order to receive the comment indicator ``NI,'' the CY
2013 revision to the code descriptor (compared to the CY 2012
descriptor) must be significant such that the new code descriptor
describes a new service or procedure for which the OPPS treatment may
change. We use comment indicator ``NI'' to indicate that these HCPCS
codes are open for comment as part of the CY 2013 OPPS/ASC final rule
with comment period. Like all codes labeled with comment indicator
``NI,'' as we stated in the CY 2013 OPPS/ASC proposed rule, we will
respond to public comments and finalize their OPPS treatment in the CY
2014 OPPS/ASC final rule with comment period.
In accordance with our usual practice, CPT and Level II HCPCS codes
that are
[[Page 68434]]
new for CY 2013 are also labeled with comment indicator ``NI'' in
Addendum B to the CY 2013 OPPS/ASC final rule with comment period.
Only HCPCS codes with comment indicator ``NI'' in this CY 2013
OPPS/ASC final rule with comment period are subject to comment. HCPCS
codes that do not appear with comment indicator ``NI'' in this CY 2013
OPPS/ASC final rule with comment period are not open to public comment,
unless we specifically request additional comments elsewhere in this
final rule with comment period. The CY 2013 treatment of HCPCS codes
that appear in this CY 2013 OPPS/ASC final rule with comment period to
which comment indicator ``NI'' is not appended was open for public
comment during the comment period for the proposed rule, and we
indicated that we would respond to those comments in this CY 2013 OPPS/
ASC final rule with comment period.
We did not receive any public comments on the proposed comment
indicators. We believe that the CY 2012 definitions of the OPPS status
indicators continue to be appropriate for CY 2013, and therefore, as
proposed, we are continuing to use those definitions without
modification for CY 2013. The final definitions are listed in Addendum
D2 on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
XIII. OPPS Policy and Payment Recommendations
A. MedPAC Recommendations
The Medicare Payment Advisory Commission (MedPAC) was established
under section 1805 of the Act to advise the Congress on issues
affecting the Medicare program. As required under the statute, MedPAC
submits reports to Congress no later than March and June of each year
that contain its Medicare payment policy recommendations. In our CY
2013 OPPS/ASC proposed rule, we noted several recommendations regarding
the OPPS from the March 2012 report (``Report to the Congress: Medicare
Payment Policy,'' available on MedPAC's Web site at: http://www.medpac.gov/documents/Mar12_EntireReport.pdf). Since the
publication of the proposed rule, MedPAC has not made any other
recommendations regarding the OPPS, although we discuss MedPAC's public
comments to our proposed rule in the applicable sections of this final
rule with comment period.
In its March report, MedPAC recommended that Congress increase
payment rates for the OPPS in CY 2013 by 1.0 percent. We discuss our
final policy to follow the statutory requirements for the CY 2013 OPD
fee schedule increase factor in section II.B of this final rule with
comment period.
In addition, MedPAC recommended that Congress enact legislation to
reduce payment rates for evaluation and management office visits
provided in hospital outpatient departments to the rates paid for these
services in physician offices. MedPAC recommended that the change be
phased in over 3 years. During the phase-in, MedPAC stated that the
associated payment reductions to hospitals with a disproportionate
share patient percentage at or above the median should be limited to 2
percent of overall Medicare payments. MedPAC also recommended that the
Secretary of Health and Human Services conduct a study by January 2015
to examine whether this policy change would reduce access to ambulatory
physician and other services for low-income patients. Congress has not
enacted such legislation.
B. GAO Recommendations
Congress established the U.S. Government Accountability Office
(GAO) under the Budget and Accounting Act of 1921 (Pub. L. 67-13) as an
independent agency that advises Congress and the heads of Executive
agencies regarding Federal program expenditures. The GAO conducts
audits and other analyses to ensure that Federal funds are being spent
efficiently and effectively. Since the issuance of the CY 2012 OPPS/ASC
final rule with comment period, the GAO has not released any reports
regarding the OPPS.
C. OIG Recommendations
The mission of the Office of the Inspector General (OIG) as
mandated by Public Law 95-452 (as amended) is to protect the integrity
of the Department of Health and Human Services programs and the health
and welfare of program beneficiaries. The OIG conducts independent
audits, inspections, and investigations to improve the efficiency of
these programs and to identify and prevent fraud, waste and abuse.
Since the issuance of the CY 2012 OPPS/ASC final rule with comment
period, the OIG has not made any recommendations regarding the OPPS.
XIV. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
1. Legislative History, Statutory Authority, and Prior Rulemaking for
the ASC Payment System
For a detailed discussion of the legislative history and statutory
authority related to ASCs, we refer readers to the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74377 through 74378) and the June
12, 1998 proposed rule (63 FR 32291 through 32292). For a discussion of
prior rulemaking on the ASC payment system, we refer readers to the CY
2012 OPPS/ASC final rule with comment period (76 FR 74378 through
74379).
2. Policies Governing Changes to the Lists of Codes and Payment Rates
for ASC Covered Surgical Procedures and Covered Ancillary Services
Under Sec. 416.2 and Sec. 416.166 of the regulations, subject to
certain exclusions, covered surgical procedures are surgical procedures
that are separately paid under the OPPS, that would not be expected to
pose a significant risk to beneficiary safety when performed in an ASC,
and that would not be expected to require active medical monitoring and
care at midnight following the procedure (``overnight stay''). We
adopted this standard for defining which surgical procedures are
covered under the ASC payment system as an indicator of the complexity
of the procedure and its appropriateness for Medicare payment in ASCs.
We use this standard only for purposes of evaluating procedures to
determine whether or not they are appropriate for Medicare
beneficiaries in ASCs. We define surgical procedures as those described
by Category I CPT codes in the surgical range from 10000 through 69999,
as well as those Category III CPT codes and Level II HCPCS codes that
directly crosswalk or are clinically similar to ASC covered surgical
procedures (72 FR 42478).
In the August 2, 2007 final rule, we also established our policy to
make separate ASC payments for the following ancillary items and
services when they are provided integral to ASC covered surgical
procedures: (1) Brachytherapy sources; (2) certain implantable items
that have pass-through status under the OPPS; (3) certain items and
services that we designate as contractor-priced, including, but not
limited to, procurement of corneal tissue; (4) certain drugs and
biologicals for which separate payment is allowed under the
[[Page 68435]]
OPPS; and (5) certain radiology services for which separate payment is
allowed under the OPPS. These covered ancillary services are specified
in Sec. 416.164(b) and, as stated previously, are eligible for
separate ASC payment (72 FR 42495). Payment for ancillary items and
services that are not paid separately under the ASC payment system is
packaged into the ASC payment for the covered surgical procedure.
We update the lists of, and payment rates for, covered surgical
procedures and covered ancillary services in conjunction with the
annual proposed and final rulemaking process to update the OPPS and the
ASC payment system (Sec. 416.173; 72 FR 42535). In addition, as
discussed in detail in section XIV.B. of this final rule with comment
period, because we base ASC payment policies for covered surgical
procedures, drugs, biologicals, and certain other covered ancillary
services on the OPPS payment policies, we also provide quarterly update
change requests (CRs) for ASC services throughout the year (January,
April, July, and October). CMS releases new Level II codes to the
public or recognizes the release of new CPT codes by the AMA and makes
these codes effective (that is, the codes are recognized on Medicare
claims) outside of the formal rulemaking process via these ASC
quarterly update CRs. Thus, the updates are to implement newly created
Level II HCPCS and Category III CPT codes for ASC payment and to update
the payment rates for separately paid drugs and biologicals based on
the most recently submitted ASP data. New Category I CPT codes, except
vaccine codes, are released only once a year and, therefore, are
implemented only through the January quarterly update. New Category I
CPT vaccine codes are released twice a year and, therefore, are
implemented through the January and July quarterly updates. We refer
readers to Table 41 in the CY 2012 OPPS/ASC proposed rule for the
process used to update the HCPCS and CPT codes (76 FR 42291).
In our annual updates to the ASC list of, and payment rates for,
covered surgical procedures and covered ancillary services, we
undertake a review of excluded surgical procedures (including all
procedures newly proposed for removal from the OPPS inpatient list),
new procedures, and procedures for which there is revised coding, to
identify any that we believe meet the criteria for designation as ASC
covered surgical procedures or covered ancillary services. Updating the
lists of covered surgical procedures and covered ancillary services, as
well as their payment rates, in association with the annual OPPS
rulemaking cycle is particularly important because the OPPS relative
payment weights and, in some cases, payment rates, are used as the
basis for the payment of covered surgical procedures and covered
ancillary services under the revised ASC payment system. This joint
update process ensures that the ASC updates occur in a regular,
predictable, and timely manner. We did not receive any public comments
on this process. Therefore, we are continuing our established process
without modification for determining the list of codes and payment
rates for ASC covered surgical procedures and covered ancillary
services.
B. Treatment of New Codes
1. Process for Recognizing New Category I and Category III CPT Codes
and Level II HCPCS Codes
CPT and Level II HCPCS codes are used to report procedures,
services, items, and supplies under the ASC payment system.
Specifically, we recognize the following codes on ASC claims: (1)
Category I CPT codes, which describe surgical procedures; (2) Category
III CPT codes, which describe new and emerging technologies, services,
and procedures; and (3) Level II HCPCS codes, which are used primarily
to identify products, supplies, temporary procedures, and services not
described by CPT codes.
We finalized a policy in the August 2, 2007 final rule to evaluate
each year all new Category I and Category III CPT codes and Level II
HCPCS codes that describe surgical procedures, and to make preliminary
determinations during the annual OPPS/ASC rulemaking process regarding
whether or not they meet the criteria for payment in the ASC setting as
covered surgical procedures and, if so, whether or not they are office-
based procedures (72 FR 42533 through 42535). In addition, we identify
new codes as ASC covered ancillary services based upon the final
payment policies of the revised ASC payment system.
We have separated our discussion below into two sections based on
whether we proposed to solicit public comments in the CY 2013 OPPS/ASC
proposed rule (and respond to those comments in this CY 2013 OPPS/ASC
final rule with comment period) or whether we are soliciting public
comments in this CY 2013 OPPS/ASC final rule with comment period (and
responding to those comments in the CY 2014 OPPS/ASC final rule with
comment period).
We note that we sought public comment in the CY 2012 OPPS/ASC final
rule with comment period on the new CPT and Level II HCPCS codes that
were effective January 1, 2012. We also sought public comments in the
CY 2012 OPPS/ASC final rule with comment period on the new Level II
HCPCS codes effective October 1, 2011. These new codes, with an
effective date of October 1, 2011, or January 1, 2012, were flagged
with comment indicator ``NI'' in Addenda AA and BB to the CY 2012 OPPS/
ASC final rule with comment period to indicate that we were assigning
them an interim payment status and payment rate, if applicable, which
were subject to public comment following publication of the CY 2012
OPPS/ASC final rule with comment period. In the proposed rule, we
stated that we would respond to public comments and finalize the ASC
treatment of these codes in this CY 2013 OPPS/ASC final rule with
comment period.
We did not receive any public comments regarding our process for
recognizing new Category I and Category III CPT codes and Level II
HCPCS codes under the ASC payment system and are implementing our
proposed policy as final, without modification, for CY 2013.
2. Treatment of New Level II HCPCS Codes and Category III CPT Codes
Implemented in April and July 2012 for Which We Solicited Public
Comments in the CY 2013 OPPS/ASC Proposed Rule
In the April and July CRs, we made effective for April 1, 2012 or
July 1, 2012, respectively, a total of 12 new Level II HCPCS codes and
5 new Category III CPT codes that were not addressed in the CY 2012
OPPS/ASC final rule with comment period. The 12 new Level II HCPCS
codes describe covered ancillary services.
In the April 2012 ASC quarterly update (Transmittal 2425, CR 7754,
dated March 16, 2012), we added one new radiology Level II HCPCS code
and four new drug and biological Level II HCPCS codes to the list of
covered ancillary services. Specifically, as displayed in Table 36 of
the CY 2013 OPPS/ASC proposed rule (77 FR 45160), we added the
following codes to the list of covered ancillary services:
HCPCS code C9288 (Injection, centruroides (scorpion)
immune f(ab)2 (equine), 1 vial);
HCPCS code C9289 (Injection, asparaginase Erwinia
chrysanthemi, 1,000international units (I.U.));
HCPCS code C9290 (Injection, bupivacaine liposome, 1 mg);
[[Page 68436]]
HCPCS code C9291 (Injection, aflibercept, 2 mg vial); and
HCPCS code C9733 (Non-ophthalmic fluorescent vascular
angiography).
In the July 2012 quarterly update (Transmittal 2479, Change Request
7854, dated May 25, 2012), we added seven new drug and biological Level
II HCPCS codes to the list of covered ancillary services. Specifically,
as displayed in Table 37 of the CY 2013 OPPS/ASC proposed rule (77 FR
45161), we added the following codes to the list of covered ancillary
services:
HCPCS code C9368 (Grafix core, per square centimeter);
HCPCS code C9369 (Grafix prime, per square centimeter);
HCPCS code Q2034 (Influenza virus vaccine, split virus,
for intramuscular use (Agriflu));
HCPCS code Q2045 (Injection, human fibrinogen concentrate,
1 mg);
HCPCS code Q2046 (Injection, aflibercept, 1 mg);
HCPCS code Q2048 (Injection, doxorubicin hydrochloride,
liposomal, doxil, 10 mg); and
HCPCS code Q2049 (Injection, doxorubicin hydrochloride,
liposomal, imported lipodox, 10 mg).
We noted that HCPCS code Q2045 replaced code J1680, HCPCS code
Q2046 replaced code C9291, and HCPCS code Q2048 replaced code J9001
beginning July 1, 2012.
We assigned payment indicator ``K2'' (Drugs and biologicals paid
separately when provided integral to a surgical procedure on the ASC
list; payment based on OPPS rate) to the 10 new Level II HCPCS codes
that are separately paid when provided in ASCs. We assigned payment
indicator ``L1'' (Influenza vaccine; pneumococcal vaccine; packaged
item/service; no separate payment made) or payment indicator ``N1''
(Packaged service/item; no separate payment made) to the two new Level
II HCPCS codes that are packaged when provided in ASCs. In the CY 2013
OPPS/ASC proposed rule (77 FR 45160), we solicited public comment on
the proposed CY 2013 ASC payment indicators and payment rates for the
covered ancillary services listed in Tables 36 and 37 of the proposed
rule (77 FR 45160 through 45161). Those HCPCS codes became payable in
ASCs, beginning in April or July 2012, and are paid at the ASC rates
posted for the appropriate calendar quarter on the CMS Web site at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/11_Addenda_Updates.html.
The HCPCS codes listed in Table 36 of the proposed rule were
included in Addendum BB to the proposed rule (which was available via
the Internet on the CMS Web site). We noted that all ASC addenda are
only available via the Internet on the CMS Web site. Because the
payment rates associated with the new Level II HCPCS codes that became
effective for July 2012 (listed in Table 37 of the proposed rule) were
not available to us in time for incorporation into the Addenda to the
OPPS/ASC proposed rule, our policy is to include these HCPCS codes and
their proposed payment indicators and payment rates in the preamble to
the proposed rule but not in the Addenda to the proposed rule. These
codes and their final payment indicators and rates are included in the
appropriate Addendum to this CY 2013 OPPS/ASC final rule with comment
period. Thus, the codes implemented by the July 2012 ASC quarterly
update CR and their proposed CY 2013 payment rates (based on July 2012
ASP data) that were displayed in Table 37 were not included in Addendum
BB to the proposed rule (which was available via the Internet on the
CMS Web site). The final list of covered ancillary services and the
associated payment weights and payment indicators is included in
Addendum BB to this CY 2013 OPPS/ASC final rule with comment period,
consistent with our annual update policy. We solicited public comment
on these proposed payment indicators and the proposed payment rates for
the new Level II HCPCS codes that were newly recognized as ASC covered
ancillary services in April and July 2012 through the quarterly update
CRs, as listed in Tables 36 and 37 of the proposed rule. We proposed to
finalize their payment indicators and their payment rates in this CY
2013 OPPS/ASC final rule with comment period.
We did not receive any public comments regarding our proposals. We
are adopting as final for CY 2013 the ASC payment indicators for the
ancillary services described by the new Level II HCPCS codes
implemented in April and July 2012 through the quarterly update CRs as
shown below, in Tables 47 and 48, respectively. These new HCPCS codes
are also displayed in Addendum BB to this final rule with comment
period. We note that after publication of the CY 2013 OPPS/ASC proposed
rule, the CMS HCPCS Workgroup created permanent HCPCS J-codes for CY
2013 to replace certain temporary HCPCS C-codes made effective for CY
2012. These permanent CY 2013 HCPCS J-codes are listed alongside the
temporary CY 2012 HCPCS C-codes in Tables 47 and 48 below.
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Through the July 2012 quarterly update CR, we also implemented ASC
payment for five new Category III CPT codes as ASC covered surgical
procedures, effective July 1, 2012. These codes were listed in Table 38
of the CY 2013 OPPS/ASC proposed rule (77 FR 45161), along with their
proposed payment indicators and proposed payment rates for CY 2013.
Because the payment rates associated with the new Category III CPT
codes that became effective for July were not available to us in time
for incorporation into the Addenda to the OPPS/ASC proposed rule, our
policy is to include the codes, their proposed payment indicators, and
proposed payment rates in the preamble to the proposed rule but not in
the Addenda to the proposed rule. The codes listed in Table 38 of the
proposed
[[Page 68438]]
rule and their final payment indicators and rates are included in
Addendum AA to this CY 2013 OPPS/ASC final rule with comment period.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45161), we proposed to
assign payment indicator ``G2'' (Non-office-based surgical procedure
added in CY 2008 or later; payment based on OPPS relative payment
weight) to three of the five new Category III CPT codes implemented in
July 2012 and to assign payment indicator ``J8'' (Device-intensive
procedure added to ASC list in CY 2008 or later; paid at adjusted rate)
to the remaining two new Category III CPT codes implemented in July
2012. We believe that these procedures would not be expected to pose a
significant safety risk to Medicare beneficiaries or would not be
expected to require an overnight stay if performed in ASCs. We
solicited public comment on these proposed payment indicators and the
payment rates for the new Category III CPT codes that were newly
recognized as ASC covered surgical procedures in July 2012 through the
quarterly update CR, as listed in Table 38 of the proposed rule (77 FR
45161). We proposed to finalize their payment indicators and their
payment rates in this CY 2013 OPPS/ASC final rule with comment period.
We did not receive any public comments regarding this proposal. We
are adopting as final for CY 2013 the ASC payment indicators for the
covered surgical procedures described by the new Category III CPT codes
implemented in the July 2012 CR as shown below in Table 49. The new CPT
codes implemented in July 2012 are also displayed in Addendum AA to
this final rule with comment period (which is available via the
Internet on the CMS Web site).
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3. Process for New Level II HCPCS Codes and Category I and III CPT
Codes for Which We Are Soliciting Public Comments in This CY 2013 OPPS/
ASC Final Rule With Comment Period
As has been our practice in the past, we incorporate those new
Category I and Category III CPT codes and new Level II HCPCS codes that
are effective January 1 in the final rule with comment period updating
the ASC payment system for the following calendar year. These codes are
released to the public via the CMS HCPCS (for Level II HCPCS codes) and
AMA Web sites (for CPT codes), and also through the January ASC
quarterly update CRs. In the past, we also have released new Level II
HCPCS codes that are effective October 1 through the October ASC
quarterly update CRs and incorporated these new codes in the final rule
with comment period updating the ASC payment system for the following
calendar year. All of these codes are flagged with comment indicator
``NI'' in Addenda AA and BB to the OPPS/ASC final rule with comment
period to indicate that we are assigning them an interim payment status
which is subject to public comment. The payment indicator and payment
rate, if applicable, for all such codes flagged with comment indicator
``NI'' are open to public comment in the OPPS/ASC final rule with
comment period, and we respond to these comments in the final rule with
comment period for the next calendar year's OPPS/ASC update. In the CY
2013 OPPS/ASC proposed rule (77 FR 45161 through 45162), we proposed to
continue this process for CY 2013. Specifically, for CY 2013, we
proposed to include in Addenda AA
[[Page 68439]]
and BB to the CY 2013 OPPS/ASC final rule with comment period the new
Category I and III CPT codes effective January 1, 2013, that would be
incorporated in the January 2013 ASC quarterly update CR and the new
Level II HCPCS codes, effective October 1, 2012 or January 1, 2013,
that would be released by CMS in its October 2012 and January 2013 ASC
quarterly update CRs. We stated that these codes would be flagged with
comment indicator ``NI'' in Addenda AA and BB to this CY 2013 OPPS/ASC
final rule with comment period to indicate that we have assigned them
an interim payment status. We also stated that their payment indicators
and payment rates, if applicable, would be open to public comment in
the CY 2013 OPPS/ASC final rule with comment period and would be
finalized in the CY 2014 OPPS/ASC final rule with comment period.
We did not receive any public comments regarding this proposed
process. For CY 2013, we are finalizing our proposal, without
modification, to continue our established process for recognizing and
soliciting public comments on new Level II HCPCS codes and Category I
and III CPT codes that become effective for the following year, as
described above.
C. Update to the Lists of ASC Covered Surgical Procedures and Covered
Ancillary Services
1. Covered Surgical Procedures
a. Additions to the List of ASC Covered Surgical Procedures
We conducted a review of all HCPCS codes that currently are paid
under the OPPS, but not included on the ASC list of covered surgical
procedures, to determine if changes in technology and/or medical
practice changed the clinical appropriateness of these procedures for
the ASC setting. In the CY 2013 OPPS/ASC proposed rule (77 FR 45162),
we proposed to update the list of ASC covered surgical procedures by
adding 16 procedures to the list. We determined that these 16
procedures would not be expected to pose a significant safety risk to
Medicare beneficiaries and would not be expected to require an
overnight stay if performed in ASCs.
The 16 procedures that we proposed to add to the ASC list of
covered surgical procedures, including their HCPCS code long
descriptors and proposed CY 2013 payment indicators, were displayed in
Table 39 of the proposed rule (77 FR 45162). We invited public comment
on this proposal.
Comment: Many commenters supported the addition of the procedures
listed in Table 39 of the CY 2013 OPPS/ASC proposed rule to the list of
ASC covered surgical procedures.
One commenter believed that CPT codes 0299T (Extracorporeal shock
wave for integumentary wound healing, high energy, including topical
application and dressing care; initial wound) and 0300T (Extracorporeal
shock wave for integumentary wound healing, high energy, including
topical application and dressing care) should not be added to the list
of ASC covered surgical procedures. The commenter agreed with CMS that
these codes would not pose a significant safety risk to Medicare
beneficiaries and would not be expected to require an overnight stay if
performed in an ASC. However, the commenter believed that additional
information on the clinical efficacy and outcomes of these services
should be collected before adding these procedures to the list of ASC
covered surgical procedures.
Response: We appreciate commenters' support of the proposed
addition of the procedures listed in Table 39 of the CY 2013 OPPS/ASC
proposed rule to the list of ASC covered surgical procedures for CY
2013. With regard to the commenter's belief that CPT codes 0299T and
0300T should not be added to the list of ASC covered surgical
procedures until additional information regarding the clinical efficacy
and outcomes of these services is collected, our policy is to review
all HCPCS codes that are currently paid under the OPPS to identify any
procedures that are currently excluded from the ASC list of covered
procedures that we believe would not pose a safety risk to Medicare
beneficiaries and would not require an overnight stay if performed in
an ASC (42 CFR 416.166). We do not make our assessment regarding what
codes should be included on the list of covered surgical procedures
based on data regarding the clinical efficacy and outcomes of the
services. Because it is our expectation that the procedures identified
by CPT codes 0299T and 0300T would not pose a significant safety risk
to Medicare beneficiaries or require an overnight stay if performed in
an ASC, we do not agree with the commenter that these procedures should
continue to be excluded from the list of ASC covered surgical
procedures.
Comment: One commenter reiterated a previous request that, with
knowledge of the anatomic location, CMS should apply the safety
criteria to the entire spectrum of services reportable by an unlisted
code. The commenter believed that under such an analysis, CMS would
determine that the following unlisted codes associated with eye
procedures would not compromise patient safety and, therefore, should
be added to the list of ASC covered surgical procedures: CPT code 66999
(Unlisted procedure, anterior segment of eye), CPT code 67299 (Unlisted
procedure, posterior segment);, CPT code 67399 (Unlisted procedure,
ocular muscle); CPT code 67999 (Unlisted procedure, eyelids); CPT code
68399 (Unlisted procedure, conjunctiva); and CPT code 68899 (Unlisted
procedure, lacrimal system).
Response: As we have stated in the past (72 FR 42484 through 42486;
75 FR 72032; and 76 FR 74380, and 74399), procedures that are reported
by the CPT unlisted codes are not eligible for addition to the ASC list
because our charge requires us to evaluate each surgical procedure for
potential safety risk and expected need for overnight monitoring and to
exclude such procedures from ASC payment. It is not possible to
evaluate procedures that would be reported by unlisted CPT codes
according to these criteria. This final policy is discussed in detail
in the August 2, 2007 final rule (72 FR 42484 through 42486).
Comment: In addition to the procedures listed in Table 39 of the CY
2013 OPPS/ASC proposed rule, commenters requested that CMS add the
procedures described by the 57 CPT codes displayed in Table 50 below to
the list of ASC covered surgical procedures. Commenters argued that
these procedures are as safe as procedures that are currently on the
list of ASC covered procedures and, based on a survey, ASCs report
positive outcomes when these procedures are performed on non-Medicare
patients.
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Response: We reviewed all of the eligible surgical procedures that
commenters requested for addition to the ASC list of covered surgical
procedures. Of the 57 requested procedures, we did not review the 22
procedures that are reported by CPT codes that are on the OPPS
inpatient list. These procedures are not paid under the OPPS and,
therefore, are not eligible for addition to the list of ASC covered
procedures. The procedures that are paid only as inpatient procedures
are identified with an asterisk in Table 50. In addition, the procedure
that is identified by CPT code 27096 (Injection procedure for
sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy
or ct) including arthrography when performed) is not paid under the
OPPS and, therefore, is not eligible for addition to the list of ASC
covered procedures.
With regard to the remaining procedures in Table 50 that commenters
requested be added to the list of ASC covered surgical procedures, we
do not agree that most of the procedures are appropriate for provision
to Medicare beneficiaries in ASCs. Although the commenters asserted
that the procedures they were requesting for addition to the list are
as safe as procedures already on the list, our review did not support
those assertions. We exclude from ASC payment any procedure for which
standard medical practice dictates that the beneficiary who undergoes
the procedure would typically be expected to require active medical
monitoring and care at midnight following the procedure (overnight
stay) as well as all surgical procedures that our medical advisors
determine may be expected to pose a significant safety risk to Medicare
beneficiaries when performed in an ASC. The criteria used under the
revised ASC payment system to identify procedures that would be
expected to pose a significant safety risk when performed in an ASC
include, but are not limited to, those procedures that: generally
result in extensive blood loss; require major or prolonged invasion of
body cavities; directly involve major blood vessels; are emergent or
life threatening in nature; commonly require systemic thrombolytic
therapy; are designated as requiring inpatient care under Sec.
419.22(n); can only be reported using a CPT unlisted surgical procedure
code; or are otherwise excluded under Sec. 411.15 (we refer readers to
Sec. 416.166).
In our review of the procedures listed in Table 50, we found that
most of the procedures either may be expected to pose a threat to
beneficiary safety or require active medical monitoring at midnight
following the procedure. Specifically, we found that prevailing medical
practice called for inpatient hospital stays for beneficiaries
undergoing many of the procedures and that some of the procedures
directly involve major blood vessels and/or may result in extensive
blood loss. Several of the urology procedures appear to require major
invasion of a body cavity. However, we agree with commenters that the
procedures described by CPT codes 0274T, 0275T, 58541, 58542, 58570,
58571, 63001, 63003, and 63005 meet the criteria under Sec. 416.166
and would be safely performed in the ASC setting and would not require
overnight stays. We are adding these CPT codes to the ASC list of
covered surgical procedures for CY 2013.
After consideration of the public comments we received, we are
finalizing the addition of the 16 procedures that we proposed to add to
the list of ASC covered surgical procedures for CY 2013. We are also
adding 9 of the procedures requested by the commenters to the CY 2013
list of
[[Page 68442]]
ASC covered surgical procedures. The procedures, their descriptors, and
payment indicators are displayed in Table 51 below.
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b. Covered Surgical Procedures Designated as Office-Based
(1) Background
In the August 2, 2007 ASC final rule, we finalized our policy to
designate as ``office-based'' those procedures that are added to the
ASC list of covered surgical procedures in CY 2008 or later years that
we determine are performed predominantly (more than 50 percent of the
time) in physicians' offices based on consideration of the most recent
available volume and utilization data for each individual procedure
code and/or, if appropriate, the clinical characteristics, utilization,
and volume of related codes. In that rule, we also finalized our policy
to exempt all procedures on the CY 2007 ASC list from application of
the office-based classification (72 FR 42512). The procedures that were
added to the ASC list of covered surgical procedures beginning in CY
2008 that we determined were office-based were identified in Addendum
AA to that rule by payment indicator ``P2'' (Office-based surgical
procedure added to ASC list in CY 2008 or later with MPFS nonfacility
PE RVUs; payment based on OPPS relative payment weight); ``P3''
(Office-based surgical procedures added to ASC list in CY 2008 or later
with MPFS nonfacility PE RVUs; payment based on MPFS nonfacility PE
RVUs); or ``R2'' (Office-based surgical procedure added to ASC list in
CY 2008 or later without MPFS nonfacility PE RVUs; payment based on
OPPS relative payment weight), depending on whether we estimated it
would be paid according to the standard ASC payment methodology based
on its OPPS relative payment weight or at the MPFS nonfacility PE RVU-
based amount.
Consistent with our final policy to annually review and update the
list of surgical procedures eligible for payment in ASCs, each year we
identify surgical procedures as either temporarily office-based,
permanently office-based, or non-office-based, after taking into
account updated volume and utilization data.
(2) Changes for CY 2013 to Covered Surgical Procedures Designated as
Office-Based
In developing the CY 2013 OPPS/ASC proposed rule, we followed our
policy to annually review and update the surgical procedures for which
ASC payment is made and to identify new procedures that may be
appropriate for ASC payment, including their potential designation as
office-based. We reviewed CY 2011 volume and utilization data and the
clinical characteristics for all surgical procedures that are assigned
payment indicator ``G2'' (Non-office-based surgical procedure added in
CY 2008 or later; payment based on OPPS relative payment weight) in CY
2012, as well as for those procedures assigned one of the temporary
office-based payment indicators, specifically ``P2*,'' ``P3*,'' or
``R2*'' in the CY 2012 OPPS/ASC final rule with comment period (76 FR
74400 through 74408).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45163), we stated that
our review of the CY 2011 volume and utilization data resulted in our
identification of six covered surgical procedures that we believe meet
the criteria for designation as office-based. We stated that the data
indicated that the procedures are performed more than 50 percent of the
time in physicians' offices, and that our medical advisors believed the
services are of a level of complexity consistent with other procedures
performed routinely in physicians' offices. The six CPT codes we
proposed to permanently designate as office-based were listed in Table
40 of the CY 2013 OPPS/ASC proposed rule (77 FR 45163), and are listed
in Table 52 below. We invited public comments on this proposal.
Comment: One commenter disagreed with the policy to make payment at
the lower of the ASC rate or the MPFS nonfacility PE RVU payment amount
for procedures that CMS identifies as office-based. This commenter
expressed concern that this policy does not provide adequate payment
for some services performed in an ASC.
Response: We have responded to this comment in the past and we
continue to
[[Page 68445]]
believe that our policy of identifying low complexity procedures that
are usually provided in physicians' offices and limiting their payment
in ASCs to the physician's office payment amount is necessary and
valid. We believe this is the most appropriate approach to prevent
payment incentives for services to move from physicians' offices to
ASCs for the many newly covered low complexity procedures on the ASC
list. We refer readers to our response to this comment in the CY 2010,
CY 2011, and CY 2012 OPPS/ASC final rules with comment period (74 FR
60605 through 60607; 75 FR 72034 through 72036; and 76 FR 74401,
respectively).
After consideration of the public comments we received, we are
finalizing our CY 2013 proposal to designate the procedures displayed
in Table 52 below as permanently office-based for CY 2013.
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We also reviewed CY 2011 volume and utilization data and other
information for the eight procedures finalized for temporary office-
based status in the CY 2012 OPPS/ASC final rule with comment period (76
FR 74404 through 74408). Among these eight procedures, there were very
few claims data for six procedures: CPT code 0099T
[[Page 68447]]
(Implantation of intrastromal corneal ring segments); CPT code 0124T
(Conjunctival incision with posterior extrascleral placement of
pharmacological agent (does not include supply of medication)); CPT
code 0226T (Anoscopy, high resolution (HRA) (with magnification and
chemical agent enhancement); diagnostic, including collection of
specimen(s) by brushing or washing when performed); CPT code 0227T
(Anoscopy, high resolution (HRA) (with magnification and chemical agent
enhancement); with biopsy(ies)); CPT code C9800 (Dermal injection
procedure(s) for facial lipodystrophy syndrome (LDS) and provision of
Radiesse or Sculptra dermal filler, including all items and supplies);
and CPT code 67229 (Treatment of extensive or progressive retinopathy,
one or more sessions; preterm infant (less than 37 weeks gestation at
birth), performed from birth up to 1 year of age (eg, retinopathy of
prematurity), photocoagulation or cryotherapy). Consequently, we
proposed in the CY 2013 OPPS/ASC proposed rule (77 FR 45163) to
maintain their temporary office-based designations for CY 2013.
The volume and utilization data for the remaining two procedures
that have temporary office-based designations for CY 2012 are
sufficient to indicate that these procedures are not performed
predominantly in physicians' offices and, therefore, should not be
assigned an office-based payment indicator in CY 2013. Consequently, we
proposed to assign payment indicator ``G2'' to the following two
covered surgical procedure codes in CY 2013:
CPT code 37761 (Ligation of perforator vein(s),
subfascial, open, including ultrasound guidance, when performed, 1
leg); and
CPT code 0232T (Injection(s), platelet rich plasma, any
tissue, including image guidance, harvesting and preparation when
performed).
The proposed CY 2013 payment indicator designations for the eight
procedures that were temporarily designated as office-based in CY 2012
were displayed in Table 41 of the CY 2013 OPPS/ASC proposed rule (77 FR
45164). The procedures for which the proposed office-based designations
for CY 2013 are temporary also were indicated by asterisks in Addendum
AA to the proposed rule (which was available via the Internet on the
CMS Web site). We invited public comments on this proposal.
We did not receive any public comments that addressed our proposal
to continue to designate six of the eight procedures, which were
designated as temporarily office-based for CY 2012, as temporarily
office-based for CY 2013. Therefore, we are finalizing our proposal to
designate the six procedures listed in Table 41 of the CY 2013 OPPS/ASC
proposed rule (77 FR 45164) and restated in Table 53 below, which were
designated as temporarily office-based for CY 2012, as temporarily
office-based for CY 2013. In addition, we did not receive any public
comments that addressed our proposal to not designate as office-based
in CY 2013 the two remaining procedures that were designated as
temporarily office-based for CY 2012. Therefore, we are finalizing our
proposal to not provide an office-based designation to the 2 procedures
listed in Table 41 of the CY 2013 OPPS/ASC proposed rule (77 FR 45164),
and restated below in Table 53, which were designated as temporarily
office-based for CY 2012.
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c. ASC Covered Surgical Procedures Designated as Device-Intensive
(1) Background
As discussed in the August 2, 2007 final rule (72 FR 42503 through
42508), we adopted a modified payment methodology for calculating the
ASC payment rates for covered surgical procedures that are assigned to
the subset of OPPS device-dependent APCs with a device offset
percentage greater than 50 percent of the APC cost under
[[Page 68449]]
the OPPS, in order to ensure that payment for the procedure is adequate
to provide packaged payment for the high-cost implantable devices used
in those procedures.
(2) Changes to List of Covered Surgical Procedures Designated as
Device-Intensive for CY 2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45164), we proposed
for CY 2013 to update the ASC list of covered surgical procedures that
are eligible for payment according to our device-intensive procedure
payment methodology, consistent with the proposed OPPS device-dependent
APC update, reflecting the proposed APC assignments of procedures,
designation of APCs as device-dependent, and APC device offset
percentages based on the CY 2011 OPPS claims and cost report data
available for the proposed rule. The OPPS device-dependent APCs are
discussed further in section II.A.2.d.(1) of this final rule with
comment period.
The ASC covered surgical procedures that we proposed to designate
as device-intensive and that would be subject to the device-intensive
procedure payment methodology for CY 2013 were listed in Table 42 of
the CY 2013 OPPS/ASC proposed rule (77 FR 45165 through 45166). The CPT
code, the CPT code short descriptor, the proposed CY 2013 ASC payment
indicator (PI), the proposed CY 2013 OPPS APC assignment, the proposed
CY 2013 OPPS APC device offset percentage, and an indication if the
full credit/partial credit (FB/FC) device adjustment policy would apply
were also listed in Table 42 of the proposed rule. All of these
procedures were included in Addendum AA to the proposed rule (which was
available via the Internet on the CMS Web site). We invited public
comments on this proposal.
Comment: Some commenters expressed the same general concerns made
in previous rulemakings regarding the sufficiency of ASC payment for
device-related services and recommended modifications to the ASC
device-intensive payment methodology. The commenters argued that CMS
should apply the device-intensive payment methodology to all procedures
for which CMS can establish a median device cost, regardless of whether
the procedures are assigned to APCs that are designated as device-
dependent under the OPPS. In a related suggestion, the commenters urged
CMS to establish the threshold used to determine device-intensive
procedures at 50 percent of the ``unadjusted'' ASC payment rate (OPPS
relative weight X ASC conversion factor) instead of the OPPS payment
rate. The commenters also made the same argument as made in prior
rulemakings--that CMS should not adjust the device portion of the ASC
payment for device-intensive procedures by the wage index.
Response: In the August 2, 2007 final rule (72 FR 42504), we
established that the modified payment methodology for calculating ASC
payment rates for device-intensive procedures shall apply to ASC
covered surgical procedures that are assigned to device-dependent APCs
under the OPPS for the same calendar year, where those APCs have a
device cost of greater than 50 percent of the APC cost (that is, the
device offset percentage is greater than 50). We continue to believe
these criteria ensure that ASC payment rates are adequate to provide
packaged payment for high cost implantable devices and ensure Medicare
beneficiaries have access to these procedures in all appropriate
settings of care.
We do not agree with the commenters that the device-intensive
methodology should be applied to all procedures where a device offset
can be established, regardless of whether the procedure is assigned to
a device-dependent APC under the OPPS. Nor do we agree with the
commenters who suggest using a threshold to determine device-intensive
procedures that is based on 50 percent of the ASC payment rate instead
of the OPPS payment rate. We continue to believe that when device costs
comprise less than 50 percent of total procedure costs, those costs are
less likely to be as predictable across sites-of-service. Accordingly,
we believe that it is possible for ASCs to achieve efficiencies
relative to HOPDs when providing those procedures, and that the
application of the ASC conversion factor to the entire ASC payment
weight is appropriate. We refer readers to our response to this comment
in the CY 2010, CY 2011, and CY 2012 OPPS/ASC final rules with comment
period (74 FR 60608 and 60609; 75 FR 72039; and 76 FR 74409,
respectively).
We also continue to believe it would not be appropriate to vary the
portion of the national payment that is wage-adjusted for different
services, such as applying the wage index only to the service portion
of the ASC payment for device-intensive procedures, as the commenters
requested. Consistent with the OPPS, we apply the ASC geographic wage
adjustment to the entire ASC payment rate for device-intensive
procedures. We refer readers to our response to this comment in the CY
2009, CY 2010, CY 2011, and CY 2012 OPPS/ASC final rules with comment
period (73 FR 68735; 74 FR 60608 through 60609; 75 FR 72039; and 76 FR
74409, respectively).
After consideration of the public comments we received, we are
designating the ASC covered surgical procedures displayed in Table 54
below as device-intensive for CY 2013. The CPT code, the CPT code short
descriptor, the final CY 2013 ASC payment indicator (PI), the final CY
2013 OPPS APC assignment, the final CY 2013 OPPS APC device offset
percentage, and an indication if the full credit/partial credit (FB/FC)
device adjustment policy will apply are also listed in Table 54 of this
final rule with comment period. As we discuss in section XIII.B.3. of
the CY 2013 OPPS/ASC proposed rule (77 FR 45161 through 45162) and this
final rule with comment period, we incorporate new Category I and
Category III CPT codes and new Level II HCPCS codes that are effective
October 1, 2012 and January 1, 2013 in this final rule with comment
period. Because these codes were not available to us until after the CY
2013 OPPS/ASC proposed rule was published, these codes were not
included in that rule. We have reviewed these new codes and have added
six of these CPT codes to Table 54 because they are ASC covered
surgical procedures and are assigned to device-dependent APCs that meet
the ASC device-intensive criteria. Specifically, we added the following
new codes to the list of ASC device-intensive procedures: CPT code
0316T (Vagus nerve blocking therapy (morbid obesity); replacement of
pulse generator); CPT code 0319T (Insertion or replacement of
subcutaneous implantable defibrillator system with subcutaneous
electrode); CPT code 0321T (Insertion of subcutaneous implantable
defibrillator pulse generator only with existing subcutaneous
electrode); CPT code 0323T (Removal of subcutaneous implantable
defibrillator pulse generator with replacement of subcutenous
implantable defibrillator pulse generator only); CPT code 24370
(Revision of total elbow arthroplasty, including allograft when
performed; humeral or ulnar component); and CPT code 24371 (Revision of
total elbow arthroplasty, including allograft when performed; humeral
and ulnar component). These new device-intensive procedures are flagged
with comment indicator ``NI'' in Addendum AA to this OPPS/ASC final
rule with comment period to indicate that we are assigning them an
interim payment status which is subject to public comment. We will
respond to any public comments received in the CY 2014 OPPS/ASC final
rule with
[[Page 68450]]
comment period. Each device-intensive procedure is assigned payment
indicator ``J8.'' All of these procedures are included in Addendum AA
to this final rule with comment period (which is available via the
Internet on the CMS Web site). The OPPS device-dependent APCs are
discussed further in section II.A.2.d.(1) of this final rule with
comment period.
d. Adjustment to ASC Payments for No Cost/Full Credit and Partial
Credit Devices
We generally discuss the no cost/full credit and partial credit
devices under the heading entitled ``ASC Payment for Covered Surgical
Procedures.'' However, because the no cost/full credit and partial
credit device policy applies to a subset of device-intensive
procedures, we believe it would be clearer to discuss the device-
intensive procedure policy and the no cost/full credit and partial
credit device policy consecutively and to consolidate the tables that
we usually publish separately. Our ASC policy with regard to payment
for costly devices implanted in ASCs at no cost/full credit or partial
credit as set forth in Sec. 416.179 is consistent with the OPPS
policy. The proposed and final CY 2013 OPPS APCs and devices subject to
the adjustment policy are discussed in section IV.B.2. of this final
rule with comment period. The established ASC policy adopts the OPPS
policy and reduces payment to ASCs when a specified device is furnished
without cost or with full credit or partial credit for the cost of the
device for those ASC covered surgical procedures that are assigned to
APCs under the OPPS to which this policy applies. We refer readers to
the CY 2009 OPPS/ASC final rule with comment period for a full
discussion of the ASC payment adjustment policy for no cost/full credit
and partial credit devices (73 FR 68742 through 68744).
Consistent with the OPPS, in the CY 2013 OPPS/ASC proposed rule (77
FR 45165), we proposed to update the list of ASC covered device-
intensive procedures and devices that would be subject to the no cost/
full credit and partial credit device adjustment policy for CY 2013.
Table 42 of the proposed rule (77 FR 45165 through 45166) displayed the
ASC covered device-intensive procedures that we proposed would be
subject to the no cost/full credit or partial credit device adjustment
policy for CY 2013. Specifically, we stated that when a procedure that
is listed in Table 42 of the proposed rule is subject to the no cost/
full credit or partial credit device adjustment policy and is performed
to implant a device that is listed in Table 43 of the proposed rule (77
FR 45166 through 45167), where that device is furnished at no cost or
with full credit from the manufacturer, the ASC would append the HCPCS
``FB'' modifier on the line with the procedure to implant the device.
The contractor would reduce payment to the ASC by the device offset
amount that we estimate represents the cost of the device when the
necessary device is furnished without cost to the ASC or with full
credit. We would provide the same amount of payment reduction based on
the device offset amount in ASCs that would apply under the OPPS under
the same circumstances. We continue to believe that the reduction of
ASC payment in these circumstances is necessary to pay appropriately
for the covered surgical procedure being furnished by the ASC.
For partial credit, we proposed to reduce the payment for
implantation procedures listed in Table 42 of the proposed rule that
are subject to the no cost/full credit or partial credit device
adjustment policy by one-half of the device offset amount that would be
applied if a device was provided at no cost or with full credit, if the
credit to the ASC is 50 percent or more of the cost of the new device.
The ASC would append the HCPCS ``FC'' modifier to the HCPCS code for a
surgical procedure listed in Table 42 of the proposed rule that is
subject to the no cost/full credit or partial credit device adjustment
policy, when the facility receives a partial credit of 50 percent or
more of the cost of a device listed in Table 43 of the proposed rule.
In order to report that they received a partial credit of 50 percent or
more of the cost of a new device, ASCs would have the option of either:
(1) Submitting the claim for the device replacement procedure to their
Medicare contractor after the procedure's performance but prior to
manufacturer acknowledgment of credit for the device, and subsequently
contacting the contractor regarding a claim adjustment once the credit
determination is made; or (2) holding the claim for the device
implantation procedure until a determination is made by the
manufacturer on the partial credit and submitting the claim with the
``FC'' modifier appended to the implantation procedure HCPCS code if
the partial credit is 50 percent or more of the cost of the replacement
device. Beneficiary coinsurance would continue to be based on the
reduced payment amount. We invited public comments on these proposals
We did not receive any comments on our CY 2013 proposal to continue
the no cost/full credit and partial credit device adjustment policy for
ASCs. For CY 2013, as we proposed, we will reduce the payment for the
device implantation procedures listed in Table 54 below that are
subject to the adjustment by the full device offset amount for no cost/
full credit cases. ASCs must append the modifier ``FB'' to the HCPCS
procedure code when the device furnished without cost or with full
credit is listed in Table 55, below, and the associated implantation
procedure code is listed in Table 54. In addition, for CY 2013, we will
reduce the payment for implantation procedures listed in Table 54 that
are subject to the adjustment by one half of the device offset amount
if a device is provided with partial credit, if the credit to the ASC
is 50 percent or more of the device cost. If the ASC receives a partial
credit of 50 percent or more of the cost of a device listed in Table
55, the ASC must append the modifier ``FC'' to the associated
implantation procedure code if the procedure is listed in Table 54.
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e. ASC Treatment of Surgical Procedures Removed From the OPPS Inpatient
List for CY 2013
As we discussed in the CY 2009 OPPS/ASC final rule with comment
period (73 FR 68724), we adopted a policy to include in our annual
evaluation of the ASC list of covered surgical procedures, a review of
the procedures that are being proposed for removal from the OPPS
inpatient list for possible inclusion on the ASC list of covered
surgical procedures. As stated in the CY 2013 OPPS/ASC proposed rule
(77 FR 45167), we evaluated each of the two procedures we proposed to
remove from the OPPS inpatient list for CY 2013 based on the criteria
for exclusion from the list of covered ASC surgical procedures. As
stated in the proposed rule, we believe that these two procedures
should continue to be excluded from the ASC list of covered surgical
procedures for CY 2013 because they would be expected to pose a
significant risk to beneficiary safety or to require an overnight stay
in ASCs. The CPT codes for these two procedures and their long
descriptors were listed in Table 44 of the proposed rule (77 FR 45167).
We invited public comments on this proposal.
We did not receive any public comments regarding the procedures
that we proposed to exclude from the list of ASC covered procedures for
CY 2013 that were proposed for removal from the CY 2013 OPPS inpatient
list. However, as detailed in section IX of this final rule with
comment period, the proposal to remove the procedure described by CPT
code 27447 (Arthroplasty, knee, condyle and plateau; medical and
lateral compartments with or without patella resurfacing (total knee
arthroplasty)) from the OPPS inpatient list is not being finalized for
CY 2013. Based on public comments received, CPT code 27447 will remain
on the OPPS inpatient list for CY 2013. Therefore, we are finalizing
our proposal to continue to exclude the procedure described by the CPT
code 22856, which is listed in Table 56 below, from the list of ASC
covered surgical procedures for CY 2013. In addition, we are excluding
CPT code 27447 because it will remain on the OPPS inpatient list for CY
2013.
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2. Covered Ancillary Services
Consistent with the established ASC payment system policy, in the
CY 2013 OPPS/ASC proposed rule (77 FR 45167), we proposed to update the
ASC list of covered ancillary services to reflect the proposed payment
status for the services under the CY 2013 OPPS. Maintaining consistency
with the OPPS may result in proposed changes to ASC payment indicators
for some covered ancillary items and services because of changes that
are being proposed under the OPPS for CY 2013. For example, a covered
ancillary service that was separately paid under the revised ASC
payment system in CY 2012 may be proposed for packaged status under the
CY 2013 OPPS and, therefore, also under the ASC payment system for CY
2013. Comment indicator ``CH,'' discussed in section XIV.F. of the CY
2013 OPPS/ASC proposed rule (77 FR 45172), was used in Addendum BB to
that proposed rule (which is available via the Internet on the CMS Web
site) to indicate covered ancillary services for which we proposed a
change in the ASC payment indicator to reflect a proposed change in the
OPPS treatment of the service for CY 2013.
Except for the Level II HCPCS codes listed in Table 37 of the CY
2013 OPPS/ASC proposed rule (77 FR 45161), all ASC covered ancillary
services and their proposed payment indicators for CY 2013 were
included in Addendum BB to that proposed rule.
We did not receive any public comments on our proposal. Therefore,
we are finalizing, without modification, our proposal to update the ASC
list of covered ancillary services to reflect the payment status for
the services under
[[Page 68456]]
the OPPS. All CY 2013 ASC covered ancillary services and their final
payment indicators are included in Addendum BB to this final rule with
comment period (which is available via the Internet on the CMS Web
site).
D. ASC Payment for Covered Surgical Procedures and Covered Ancillary
Services
1. Payment for Covered Surgical Procedures
a. Background
Our ASC payment policies for covered surgical procedures under the
revised ASC payment system are fully described in the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66828 through 66831). Under our
established policy for the revised ASC payment system, the ASC standard
ratesetting methodology of multiplying the ASC relative payment weight
for the procedure by the ASC conversion factor for that same year is
used to calculate the national unadjusted payment rates for procedures
with payment indicators ``G2'' and ``A2.'' Payment indicator ``A2'' was
developed to identify procedures that were included on the list of ASC
covered surgical procedures in CY 2007 and were, therefore, subject to
transitional payment prior to CY 2011. Although the 4-year transitional
period has ended and payment indicator ``A2'' is no longer required to
identify surgical procedures subject to transitional payment, we
retained payment indicator ``A2'' because it is used to identify
procedures that are exempted from application of the office-based
designation.
The rate calculation established for device-intensive procedures
(payment indicator ``J8'') is structured so that the packaged device
payment amount is the same as under the OPPS, and only the service
portion of the rate is subject to the ASC standard ratesetting
methodology. In the CY 2012 OPPS/ASC final rule with comment period (76
FR 74377 through 74451), we updated the CY 2011 ASC payment rates for
ASC covered surgical procedures with payment indicators of ``A2,''
``G2,'' and ``J8'' using CY 2010 data, consistent with the CY 2012 OPPS
update. Payment rates for device-intensive procedures also were updated
to incorporate the CY 2012 OPPS device offset percentages.
Payment rates for office-based procedures (payment indicators
``P2,'' ``P3,'' and ``R2'') are the lower of the MPFS nonfacility PE
RVU-based amount (we refer readers to the CY 2013 MPFS final rule with
comment period) or the amount calculated using the ASC standard
ratesetting methodology for the procedure. In the CY 2012 OPPS/ASC
final rule with comment period, we updated the payment amounts for
office-based procedures (payment indicators ``P2,'' ``P3,'' and ``R2'')
using the most recent available MPFS and OPPS data. We compared the
estimated CY 2012 rate for each of the office-based procedures,
calculated according to the ASC standard ratesetting methodology, to
the MPFS nonfacility PE RVU-based amount to determine which was lower
and, therefore, would be the CY 2012 payment rate for the procedure
according to the final policy of the revised ASC payment system (Sec.
416.171(d)).
b. Update to ASC Covered Surgical Procedure Payment Rates for CY 2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45168), we proposed to
update ASC payment rates for CY 2013 using the established rate
calculation methodologies under Sec. 416.171. We note that, as
discussed in section II.A.2.f. of that proposed rule (77 FR 45094
through 45098), because we proposed to base the OPPS relative payment
weights on geometric mean costs for CY 2013, the ASC system would shift
to the use of geometric means to determine relative payment weights
under the ASC standard ratesetting methodology. We proposed to continue
to use the amount calculated under the ASC standard ratesetting
methodology for procedures assigned payment indicators ``A2'' and
``G2.''
We proposed that payment rates for office-based procedures (payment
indicators ``P2,'' ``P3,'' and ``R2'') and device-intensive procedures
(payment indicator ``J8'') be calculated according to our established
policies, incorporating the device-intensive procedure methodology as
appropriate. Thus, we proposed to update the payment amounts for
device-intensive procedures based on the CY 2013 OPPS proposal that
reflects updated proposed OPPS device offset percentages, and to make
payment for office-based procedures at the lesser of the proposed CY
2013 MPFS nonfacility PE RVU-based amount or the proposed CY 2013 ASC
payment amount calculated according to the standard ratesetting
methodology. We invited public comments on these proposals.
We did not receive any public comments on our proposal to calculate
CY 2013 payment rates for ASC-covered surgical procedures according to
our established methodologies. Therefore, we are finalizing our CY 2013
proposal, without modification, to calculate the CY 2013 final ASC
payment rates for ASC-covered surgical procedures according to our
established methodologies.
c. Waiver of Coinsurance and Deductible for Certain Preventive Services
As discussed in the CY 2013 OPPS/ASC proposed rule (77 FR 45168),
section 1833(a)(1) and section 1833(b)(1) of the Act waive the
coinsurance and the Part B deductible for those preventive services
under section 1861(ddd)(3)(A) of the Act as described in section
1861(ww)(2) of the Act (excluding electrocardiograms) that are
recommended by the United States Preventive Services Task Force
(USPSTF) with a grade of A or B for any indication or population and
that are appropriate for the individual. Section 1833(b) of the Act
also waives the Part B deductible for colorectal cancer screening tests
that become diagnostic. In the CY 2011 OPPS/ASC final rule with comment
period, we finalized our policies with respect to these provisions and
identified the ASC covered surgical procedures and covered ancillary
services that are preventive services that are recommended by the
USPSTF with a grade of A or B for which the coinsurance and the
deductible are waived. For a complete discussion of our policies and
identified services, we refer readers to the CY 2011 OPPS/ASC final
rule with comment period (75 FR 72047 through 72049). We did not
propose any changes to our policies or the categories of services in
the CY 2013 OPPS/ASC proposed rule. We identify the specific services
with a double asterisk in Addenda AA and BB to this CY 2013 OPPS/ASC
final rule with comment period.
d. Payment for the Cardiac Resynchronization Therapy Composite
Cardiac resynchronization therapy (CRT) uses electronic devices to
sequentially pace both sides of the heart to improve its output. CRT
utilizes a pacing electrode implanted in combination with either a
pacemaker or an implantable cardioverter defibrillator (ICD). CRT
performed by the implantation of an ICD along with a pacing electrode
is referred to as ``CRT-D.'' In the CY 2012 OPPS/ASC final rule with
comment period, we finalized our proposal to establish the CY 2012 ASC
payment rate for CRT-D services based on the OPPS payment rate
applicable to APC 0108 when procedures described by CPT codes 33225 and
33249 are performed on the same date of service in an ASC. ASCs use the
corresponding HCPCS Level II G-code (G0448) for proper reporting when
the procedures
[[Page 68457]]
described by CPT codes 33225 and 33249 are performed on the same date
of service. For a complete discussion of our policy regarding payment
for CRT-D services in ASCs, we refer readers to the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74427 through 74428). We did not
propose any changes to our current policy regarding ASC payment for
CRT-D services for CY 2013.
e. Payment for Low Dose Rate (LDR) Prostate Brachytherapy Composite
LDR prostate brachytherapy is a treatment for prostate cancer in
which hollow needles or catheters are inserted into the prostate,
followed by permanent implantation of radioactive sources into the
prostate through the needles/catheters. At least two CPT codes are used
to report the treatment service because there are separate codes that
describe placement of the needles/catheters and the application of the
brachytherapy sources: CPT code 55875 (Transperineal placement of
needles or catheters into prostate for interstitial radioelement
application, with or without cystoscopy) and CPT code 77778
(Interstitial radiation source application; complex). Generally, the
component services represented by both codes are provided in the same
operative session on the same date of services to the Medicare
beneficiary being treated with LDR brachytherapy for prostate cancer.
As detailed in section II.A.2.e.(2) of the CY 2013 OPPS/ASC
proposed rule (77 FR 45088 through 45089), in CY 2008 under the OPPS,
we began providing a single payment for LDR prostate brachytherapy when
the composite service, reported as CPT codes 55875 and 77778, is
furnished in a single hospital encounter. We based the payment for
composite APC 8001 (LDR Prostate Brachytherapy Composite) on the cost
derived from claims for the same date of service that contain both CPT
codes 55875 and 77778 and that do not contain other separately paid
codes that are not on the bypass list. We implemented this policy in
the OPPS because reliance on single procedure claims to set payment
rates for these services resulted in the use of mainly incorrectly
coded claims for LDR prostate brachytherapy because a correctly coded
claim should include, for the same date of service, CPT codes for both
needle/catheter placement and application of radiation sources, as well
as separately coded imaging and radiation therapy planning services (72
FR 66652 through 66655).
Currently under the ASC payment system, ASCs receive separate
payment for the component services that comprise the LDR Prostate
Brachytherapy Composite when the two services are provided on the same
date of service. Specifically, ASCs that report CPT codes 55875 and
77778 on the same date of service receive a payment for CPT code 55875
where the payment rate is based on the OPPS relative payment weight for
single procedure claims, and a separate payment for CPT code 77778
where payment is the lower of the rate based on the OPPS relative
payment weight for single procedure claims or the MPFS nonfacility PE-
RVU based amount.
A commenter to the CY 2012 OPPS/ASC proposed rule (76 FR 74429
through 74430) requested that CMS pay for LDR prostate brachytherapy
services under the ASC payment system based on the composite OPPS
payment rate rather than making two separate payments for the service
reported by CPT codes 55875 and 77778. The commenter asserted that
basing ASC payments for the services on the composite APC methodology
in which one payment is made for the combination of the two services
would result in a more accurate payment than is currently being made to
ASCs because ASC payment is based on costs from single-service claims
that CMS has acknowledged are mostly incorrectly coded claims. We
responded that we would take the commenter's request into consideration
in future rulemaking, recognizing the lead time that is necessary for
the creation of the associated G-code that would be used to identify
when the procedures in the LDR prostate brachytherapy composite are
performed on the same date of service in an ASC.
Because we agree that data from OPPS claims reporting both services
required for LDR prostate brachytherapy provide the most accurate
relative payment weight upon which to base ASC payment for the
component services, in the CY 2013 OPPS/ASC proposed rule (77 FR
45169), we proposed to establish an ASC payment rate that is based on
the OPPS relative payment weight applicable to APC 8001 when CPT codes
55875 and 77778 are performed on the same date of service in an ASC. We
also proposed to create a HCPCS Level II G-code so that ASCs can
properly report when the procedures described by CPT codes 55875 and
77778 are performed on the same date of service and, therefore, receive
the appropriate LDR Prostate Brachytherapy Composite payment. We stated
that the payment rate associated with the LDR prostate brachytherapy
composite will be temporarily identified by HCPCS G-code ``GXXX1'' in
Addendum AA to the CY 2013 OPPS/ASC proposed rule and the permanent
HCPCS G-code that will identify this composite for ASCs will appear in
this final rule with comment period. When not performed on the same day
as the service described by CPT code 55875, the service described by
CPT code 77778 will continue to be assigned to APC 0651. When not
performed on the same day as the service described by CPT code 77778,
the service described by CPT code 55875 will continue to be assigned to
APC 0163. We invited public comment on this proposal.
Comment: Several commenters supported CMS' proposal to establish an
ASC payment rate that is based on the OPPS relative payment weight
applicable to APC 8001 when CPT codes 55875 and 77778 are performed on
the same date of service in an ASC.
Response: We appreciate commenters' support of our proposal. We are
finalizing our proposal, without modification, to establish the CY 2013
ASC payment rate for LDR prostate brachytherapy services based on the
OPPS relative payment weight applicable to APC 8001 when CPT codes
55875 and 77778 are performed on the same date of service in an ASC.
ASCs will use the corresponding HCPCS Level II G-code (G0458) for
proper reporting when the procedures described by CPT codes 55875 and
77778 are performed on the same date of service, and therefore receive
the appropriate LDR prostate brachytherapy composite payment. When not
performed on the same day as the service described by CPT code 55875,
the service described by CPT code 77778 will continue to be assigned to
APC 0651. When not performed on the same day as the service described
by CPT code 77778, the service described by CPT code 55875 will
continue to be assigned to APC 0163.
2. Payment for Covered Ancillary Services
a. Background
Our final payment policies under the revised ASC payment system for
covered ancillary services vary according to the particular type of
service and its payment policy under the OPPS. Our overall policy
provides separate ASC payment for certain ancillary items and services
integrally related to the provision of ASC covered surgical procedures
that are paid separately under the OPPS and provides packaged ASC
payment for other ancillary items and services that are packaged or
conditionally packaged
[[Page 68458]]
(status indicators ``N,'' ``Q1,'' and ``Q2'') under the OPPS. In the CY
2013 OPPS/ASC proposed rule (77 FR 45169), we further clarified our
policy regarding the payment indicator assignment of codes that are
conditionally packaged in the OPPS (status indicators ``Q1'' and
``Q2''). Under the OPPS, a conditionally packaged code describes a
HCPCS code where the payment is packaged when it is provided with a
significant procedure but is separately paid when the service appears
on the claim without a significant procedure. Because ASC services
always include a surgical procedure, HCPCS codes that are conditionally
packaged under the OPPS are always packaged (payment indictor ``N1'')
under the ASC payment system. Thus, our final policy aligns ASC payment
bundles with those under the OPPS (72 FR 42495). In all cases, in order
for those ancillary services also to be paid, ancillary items and
services must be provided integral to the performance of ASC covered
surgical procedures for which the ASC bills Medicare.
Our ASC payment policies provide separate payment for drugs and
biologicals that are separately paid under the OPPS at the OPPS rates,
while we generally pay for separately payable radiology services at the
lower of the MPFS nonfacility PE RVU-based (or technical component)
amount or the rate calculated according to the ASC standard ratesetting
methodology (72 FR 42497). However, as finalized in the CY 2011 OPPS/
ASC final rule with comment period (75 FR 72050), payment indicators
for all nuclear medicine procedures (defined as CPT codes in the range
of 78000 through 78999) that are designated as radiology services that
are paid separately when provided integral to a surgical procedure on
the ASC list are set to ``Z2'' so that payment is made based on the ASC
standard ratesetting methodology rather than the MPFS nonfacility PE
RVU amount, regardless of which is lower. This modification to the ASC
payment methodology for ancillary services was finalized in response to
a comment on the CY 2011 OPPS/ASC proposed rule that suggested it is
inappropriate to use the MPFS-based payment methodology for nuclear
medicine procedures because the associated diagnostic
radiopharmaceutical, although packaged under the ASC payment system, is
separately paid under the MPFS. We set the payment indicator to ``Z2''
for these nuclear medicine procedures in the ASC setting so that
payment for these procedures would be based on the OPPS relative
payment weight rather than the MPFS nonfacility PE RVU-based amount to
ensure that the ASC will be compensated for the cost associated with
the diagnostic radiopharmaceuticals.
In addition, because the same issue exists for radiology procedures
that use contrast agents (the contrast agent is packaged under the ASC
payment system but is separately paid under the MPFS), we finalized in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74429
through 74430) to set the payment indicator to ``Z2'' for radiology
services that use contrast agents so that payment for these procedures
will be based on the OPPS relative payment weight and will, therefore,
include the cost for the contrast agent.
ASC payment policy for brachytherapy sources mirrors the payment
policy under the OPPS. ASCs are paid for brachytherapy sources provided
integral to ASC covered surgical procedures at prospective rates
adopted under the OPPS or, if OPPS rates are unavailable, at
contractor-priced rates (72 FR 42499). Since December 31, 2009, ASCs
have been paid for brachytherapy sources provided integral to ASC
covered surgical procedures at prospective rates adopted under the
OPPS.
Other separately paid covered ancillary services in ASCs,
specifically corneal tissue acquisition and device categories with OPPS
pass-through status, do not have prospectively established ASC payment
rates according to the final policies of the revised ASC payment system
(72 FR 42502 and 42508 through 42509; 42 CFR 416.164(b)). Under the
revised ASC payment system, corneal tissue acquisition is paid based on
the invoiced costs for acquiring the corneal tissue for
transplantation. Devices that are eligible for pass-through payment
under the OPPS are separately paid under the ASC payment system.
Currently, the four devices that are eligible for pass-through payment
in the OPPS are described by HCPCS code C1749 (Endoscope, retrograde
imaging/illumination colonoscope device (Implantable)), HCPCS code
C1830 (Powered bone marrow biopsy needle), HCPCS code C1840 (Lens,
intraocular (telescopic)), and HCPCS code C1886 (Catheter,
extravascular tissue ablation, any modality (insertable)). Payment
amounts for HCPCS codes C1749, C1830, C1840, and C1886 under the ASC
payment system are contractor priced. In the CY 2012 OPPS/ASC final
rule with comment period, we finalized the expiration of pass-through
payment for HCPCS code C1749, which will expire after December 31, 2012
(76 FR 74278). Therefore, after December 31, 2012, the HCPCS code C1749
device costs will be packaged into the costs of the procedures with
which the devices are reported in the hospital claims data used in the
development of the OPPS relative payment weights that will be used to
establish ASC payment rates for CY 2013.
b. Payment for Covered Ancillary Services for CY 2013
For CY 2013, we proposed to update the ASC payment rates and make
changes to ASC payment indicators as necessary to maintain consistency
between the OPPS and ASC payment system regarding the packaged or
separately payable status of services and the proposed CY 2013 OPPS and
ASC payment rates (77 FR 45170). The proposed CY 2013 OPPS payment
methodologies for brachytherapy sources and separately payable drugs
and biologicals were discussed in section II.A. and section V.B. of
that proposed rule, respectively, and we proposed to set the CY 2013
ASC payment rates for those services equal to the proposed CY 2013 OPPS
rates.
Consistent with established ASC payment policy (72 FR 42497), the
proposed CY 2013 payment for separately payable covered radiology
services was based on a comparison of the CY 2013 proposed MPFS
nonfacility PE RVU-based amounts (we referred readers to the CY 2013
MPFS proposed rule) and the proposed CY 2013 ASC payment rates
calculated according to the ASC standard ratesetting methodology and
then set at the lower of the two amounts (except as discussed below for
nuclear medicine procedures and radiology services that use contrast
agents). Alternatively, payment for a radiology service may be packaged
into the payment for the ASC covered surgical procedure if the
radiology service is packaged or conditionally packaged under the OPPS.
The payment indicators in Addendum BB to the proposed rule indicate
whether the proposed payment rates for radiology services are based on
the MPFS nonfacility PE RVU-based amount or the ASC standard
ratesetting methodology, or whether payment for a radiology service is
packaged into the payment for the covered surgical procedure (payment
indicator ``N1''). Radiology services that we proposed to pay based on
the ASC standard ratesetting methodology are assigned payment indicator
``Z2'' (Radiology service paid separately when provided integral to a
surgical procedure on ASC list; payment
[[Page 68459]]
based on OPPS relative payment weight) and those for which the proposed
payment is based on the MPFS nonfacility PE RVU-based amount are
assigned payment indicator ``Z3'' (Radiology service paid separately
when provided integral to a surgical procedure on ASC list; payment
based on MPFS nonfacility PE RVUs).
As finalized in the CY 2011 OPPS/ASC final rule with comment period
(75 FR 72050), payment indicators for all nuclear medicine procedures
(defined as CPT codes in the range of 78000 through 78999) that are
designated as radiology services that are paid separately when provided
integral to a surgical procedure on the ASC list are set to ``Z2'' so
that payment is made based on the OPPS relative payment weights rather
than the MPFS nonfacility PE RVU-based amount, regardless of which is
lower. As finalized in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74429 through 74430), payment indicators for radiology
services that use contrast agents are set to ``Z2'' so that payment for
these procedures will be based on the OPPS relative payment weight and,
therefore, will include the cost for the contrast agent. In the CY 2013
OPPS/ASC proposed rule (77 FR 45170), we proposed for CY 2013 to
continue these modifications to the payment methodology and, therefore,
set the payment indicator to ``Z2'' for these covered ancillary
radiology services that involve nuclear medicine procedures or that use
contrast agents.
Most covered ancillary services and their proposed payment
indicators were listed in Addendum BB to the CY 2013 OPPS/ASC proposed
rule (which is available via the Internet on the CMS Web site). We
invited public comment on these proposals.
Comment: One commenter expressed appreciation to CMS for its
responsiveness in the CY 2011 OPPS/ASC final rule with comment period
to stakeholder concerns regarding ASC payment for nuclear medicine
procedures. However, the commenter suggested that ASC payment policy
for nuclear medicine procedures would be further improved by providing
separate payment for the diagnostic radiopharmaceuticals that are used
in nuclear medicine procedures.
Response: As we stated in the CY 2011 OPPS/ASC final rule with
comment period (75 FR 72050) regarding separate payment for diagnostic
radiopharmaceuticals used in ASCs, we do not agree with the commenter
that we should establish separate payment for diagnostic
radiopharmaceuticals under the ASC payment system because we follow the
OPPS packaging policies which require that payment for these items is
always packaged.
After consideration of the public comments we received, we are
providing CY 2013 payment for covered ancillary services in accordance
with the policies finalized in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74430). Covered ancillary services and their
final CY 2013 payment indicators are listed in Addendum BB (which is
available via the Internet on the CMS Web site) to this final rule with
comment period.
E. New Technology Intraocular Lenses (NTIOLs)
1. NTIOL Cycle and Evaluation Criteria
In the CY 2007 OPPS/ASC final rule with comment period (71 FR
68176), we finalized our current process for reviewing applications to
establish new classes of new technology intraocular lenses (NTIOLs),
and for recognizing new candidate intraocular lenses (IOLs) inserted
during or subsequent to cataract extraction as belonging to an NTIOL
class that is qualified for a payment adjustment. Specifically, we
established the following process:
We announce annually in the proposed rule updating the ASC
and OPPS payment rates for the following calendar year, a list of all
requests to establish new NTIOL classes accepted for review during the
calendar year in which the proposal is published. In accordance with
section 141(b)(3) of Pub. L. 103-432 and our regulations at Sec.
416.185(b), the deadline for receipt of public comments is 30 days
following publication of the list of requests in the proposed rule.
In the final rule updating the ASC and OPPS payment rates
for the following calendar year, we--
[cir] Provide a list of determinations made as a result of our
review of all new NTIOL class requests and public comments; and
[cir] Announce the deadline for submitting requests for review of
an application for a new NTIOL class for the following calendar year.
In the CY 2007 OPPS/ASC final rule with comment period (71 FR
68227), we finalized our proposal to base our determinations on
consideration of the following major criteria set out at 42 CFR
416.195:
42 CFR 416.195(a)(1): The IOL is approved by the FDA;
42 CFR 416.195(a)(2): Claims of specific clinical benefits
and/or lens characteristics with established clinical relevance in
comparison with currently available IOLs are approved by the FDA for
use in labeling and advertising;
42 CFR 416.195(a)(3): The IOL is not described by an
active or expired NTIOL class; that is, it does not share the
predominant, class-defining characteristic associated with the improved
clinical outcome with designated members of an active or expired NTIOL
class; and
42 CFR 416.195(a)(4): Evidence demonstrates that use of
the IOL results in measurable, clinically meaningful, improved outcomes
in comparison with use of currently available IOLs. The statute
requires us to consider the following improved outcomes:
[cir] Reduced risk of intraoperative or postoperative complication
or trauma;
[cir] Accelerated postoperative recovery;
[cir] Reduced induced astigmatism;
[cir] Improved postoperative visual acuity;
[cir] More stable postoperative vision; or
[cir] Other comparable clinical advantages.
Since implementation of the process for adjustment of payment
amounts for NTIOLs that was established in the June 16, 1999 Federal
Register, we have approved three classes of NTIOLs, as shown in the
table with the associated qualifying IOL models, at the link entitled
``NTIOL Application Determination Reference document Updated 01/06/
2012,'' posted on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/NTIOLs.html.
2. NTIOL Application Process for Payment Adjustment
For a request to be considered complete, we require submission of
the information that is found in the guidance document entitled
``Application Process and Information Requirements for Requests for a
New Class of New Technology Intraocular Lens (NTIOL)'' posted on the
CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/NTIOLs.html. For each completed request for a new
class that is received by the established deadline, a determination is
announced annually in the final rule updating the ASC and OPPS payment
rates for the next calendar year.
We also summarize briefly in the final rule the evidence that we
reviewed, the public comments we received timely, and the basis for our
determinations in consideration of applications for establishment of a
new NTIOL class. When a new NTIOL class is created, we identify the
predominant characteristic of NTIOLs in that class that sets them apart
from other IOLs (including those
[[Page 68460]]
previously approved as members of other expired or active NTIOL
classes) and that is associated with an improved clinical outcome. The
date of implementation of a payment adjustment in the case of approval
of an IOL as a member of a new NTIOL class would be set prospectively
as of 30 days after publication of the ASC payment update final rule,
consistent with the statutory requirement.
3. Requests To Establish New NTIOL Classes for CY 2013 and Deadline for
Public Comments
As discussed in the CY 2013 OPPS/ASC proposed rule (77 FR 45171),
we did not receive any requests for review to establish a new NTIOL
class for CY 2013 by the March 2, 2012 due date (this due date was
stated in the CY 2012 OPPS/ASC final rule with comment period at 76 FR
74443).
4. Payment Adjustment
The current payment adjustment for a 5-year period from the
implementation date of a new NTIOL class is $50 per lens. Since
implementation of the process for adjustment of payment amounts for
NTIOLs in 1999, we have not revised the payment adjustment amount, and
in the CY 2013 OPPS/ASC proposed rule (77 FR 45171), we did not propose
to revise the payment adjustment amount for CY 2013.
5. Revisions to the Major NTIOL Criteria Described in 42 CFR 416.195
The last significant revisions to the regulations containing the
substantive NTIOL evaluation criteria under 42 CFR 416.195 occurred in
2007. In the CY 2013 OPPS/ASC proposed rule (77 FR 45171), we proposed
significant revisions to Sec. 416.195(a)(2) and Sec. 416.195(a)(4).
We stated our belief that revising Sec. 416.195 is necessary in order
to improve the quality of the NTIOL applications. In recent years, we
have received low quality NTIOL applications that may have been due in
part to overly-broad evaluation criteria.
We proposed to revise Sec. 416.195(a)(2) to require that the IOL's
FDA-approved labeling contains a claim of a specific clinical benefit
imparted by a new lens characteristic. The IOL would have to have a new
lens characteristic in comparison to currently available IOLs. We also
proposed to revise Sec. 416.195(a)(4) to require that any specific
clinical benefit referred to in Sec. 416.195(a)(2) would have to be
supported by evidence that demonstrated that the IOL results in a
measurable, clinically meaningful, improved outcome. Improved outcomes
include: (i) Reduced risk of intraoperative or postoperative
complication or trauma; (ii) accelerated postoperative recovery; (iii)
reduced induced astigmatism; (iv) improved postoperative visual acuity;
(v) more stable postoperative vision; and (vi) other comparable
clinical advantages.
The proposed revision to Sec. 416.195(a)(2) is necessary because
recent NTIOL applications have not included FDA labeling claims of
clinical benefit. Instead, the candidate IOLs have, in most cases, had
some characteristic for which the applicant has tried to prove clinical
relevance through various kinds of evidence that have not been
evaluated by the FDA because the evidence is not associated with a
labeling claim. The result has been the submission of low quality
evidence that has been insufficient for NTIOL status. We believe that
the quality of the evidence would improve if applicants were required
to obtain a labeling claim for the NTIOL benefit and therefore have the
evidence for such benefit evaluated by FDA. We believe that this
proposed approach would better serve CMS, FDA, and the applicants
because any ultimate grant of NTIOL status would be supported by a
labeling claim. The manufacturer could then advertise the NTIOL benefit
without running afoul of FDA advertising limitations. We would have the
benefit of an FDA review of the relevant evidence, which would be
particularly valuable because the FDA has a dedicated team of
scientists, physicians, and engineers who are experts in evaluating
IOLs.
The proposed revision to Sec. 416.195(a)(4) is necessary to insure
that the claim is clinically relevant and represents an improved
outcome for Medicare beneficiaries. We requested public comments on
these proposed revisions to the NTIOL regulations.
Comment: Several commenters supported our proposed changes to the
NTIOL regulations. These commenters believed that the proposed changes
will better insure that any grants of NTIOL status will be supported by
rigorous scientific evidence.
Response: We appreciate these comments and the commenters' support
for our efforts to require rigor and accountability in the NTIOL
program.
Comment: One commenter disagreed with the proposed revision to
416.195(a)(2), complaining that obtaining a label claim is difficult
and time consuming. In addition, this commenter made the following main
points:
It is not the FDA's job to review evidence related to an
NTIOL application;
FDA does not typically evaluate claims of comparative
clinical benefits, and is not obligated to do so;
Clinical studies to support a label claim require
substantial time and resources, and there is no guarantee that such
efforts will be successful;
Other new technology programs, such as transitional pass-
through payments, do not require a claim of clinical benefit;
Requiring a claim of clinical benefit would provide
extended exclusivity to the first company to establish the NTIOL class;
Requiring a claim of clinical benefit will limit patient
access to new technology.
Response: We believe that this commenter's objections reflect at
least a partial misunderstanding of the proposal. Our current
regulations require that the FDA approved label contain information
about the clinical benefit of a candidate IOL. They provide two options
for satisfying this requirement; the candidate lens must have either:
(1) claims of specific clinical benefits in comparison with currently
available IOLs approved by the FDA for use in labeling and advertising;
or (2) lens characteristics with established clinical relevance in
comparison with currently available IOLs approved by the FDA for use in
labeling and advertising. Both of these options require evaluation by
the FDA. In recent years, lens manufacturers have used Option 2 to
claim, for example, that the applicant lens had a specific lens
characteristic (for example, blue filter, availability in .25 D
increments, absence of glistenings, packaging in a disposable injector)
listed somewhere in the FDA labeling; however, the manufacturer would
provide no information about the clinical relevance of this
characteristic in the FDA's labeling. The manufacturer would submit to
CMS weak or nonexistent evidence of a clinical benefit that it claimed
could be attributed to the characteristic described on the FDA-approved
label. We believe that to remedy this problem and to clarify the intent
of this regulation it is necessary that the label contain a claim of a
clinical benefit, which would be supported by evidence evaluated by the
FDA.
Regarding this commenter's statement about the scope of FDA's
duties, the evaluation of clinical evidence in support of a labeling
claim is a core function of the FDA and is something that they do on a
daily basis. There is nothing unusual about the FDA's proposed role as
it relates to evaluating evidence in support of a labeling claim
[[Page 68461]]
that could be used to satisfy the requirements for NTIOL status. This
rule does not usurp or interfere with any functions currently carried
out by the FDA.
Regarding this commenter's other points, the various new technology
payment programs we administer have somewhat different requirements,
depending on the statutory authority and the specific purposes of the
various programs. We believe that Congress intended that NTIOL status
function as an incentive for innovation. If requiring a claim of
clinical benefit results in a longer period of a single manufacturer
utilizing a new NTIOL class exclusively, we believe that such extended
exclusivity would serve as an additional inducement for manufacturers
to innovate and seek NTIOL status for their innovations. While we agree
with the commenter that seeking a label claim requires time and effort,
we believe that this process will better serve NTIOL applicants in that
having a claim of a clinical benefit will substantially increase the
likelihood of ultimate NTIOL approval.
Finally, this commenter predicted that if we finalize these
proposed changes to the regulations, then Medicare beneficiaries will
have reduced access to new IOL technology. We disagree that the
proposed changes to the NTIOL regulations will affect patient access to
IOLs. For example, one of the 2012 NTIOL candidate IOLs had been on the
market for 10 years and was the U.S. market leader at the time of NTIOL
application. Lack of NTIOL status did not limit patient access to this
IOL and we believe that it would also be unlikely to result in limited
access to future IOLs. We also believe that having NTIOLs supported by
a labeling claim of clinical benefit will increase patient confidence
that they are receiving a medical device with a real evidence-based
benefit versus existing technology.
After consideration of the public comments we received, we are
finalizing the proposed changes to the NTIOL regulations.
6. Request for Public Comment on the ``Other Comparable Clinical
Advantages'' Improved Outcome
Section 416.195(a)(4)), discussed above, lists the following
improved outcomes: (i) Reduced risk of intraoperative or postoperative
complication or trauma; (ii) accelerated postoperative recovery; (iii)
reduced induced astigmatism; (iv) improved postoperative visual acuity;
(v) more stable postoperative vision; and (vi) other comparable
clinical advantages.
This list is from the original 1994 NTIOL statutory provision.
Because this provision is almost 20 years old, outcomes (i) through (v)
have only limited relevance to modern cataract surgery. For example,
regarding outcome (i), it is unclear what, if any, type of IOL could
reduce the risk of complication or trauma associated with cataract
surgery, or what, if any, contemporary cataract surgery complication
could be affected by a new type of IOL. As for outcome (ii),
postoperative recovery is already rapid in uncomplicated cataract
surgery; therefore, it is difficult to see how it could be
significantly accelerated. Also, regarding outcome (iii), clinically
significant induced astigmatism would be reflective of poor surgical
technique and would not depend upon IOL design. Regarding outcome (iv),
currently available IOLs provide such high quality postoperative visual
acuity that it would be difficult to measure clinically significant
improved postoperative visual acuity due to a new type of IOL. Finally,
for outcome (v), postoperative vision is typically stable after
uncomplicated cataract surgery, so again it would be difficult to
improve upon this outcome.
The last of the listed improved outcomes is the nonspecific
category described as ``other comparable clinical advantages.'' Given
that present-day cataract surgery is such a successful procedure that
results in significantly improved vision for almost all patients who
undergo the procedure and who are appropriate candidates for cataract
surgery, in the CY 2013 OPPS/ASC proposed rule (77 FR 45172), we
solicited comments on what potential benefits associated with a new IOL
could be considered to be a ``comparable clinical advantage'' as
compared to the list of the five improved outcomes from the statute and
regulation described above.
Comment: Several commenters supported retaining the ``comparable
clinical advantage'' outcome as an open-ended category as necessary to
accommodate future innovations. One commenter offered the following
examples of potential comparable clinical advantages:
Reduced incidence of posterior capsular opacity;
Improved delivery to reduce error and minimize changes to
the wound from insertion'
Reduced inflammation;
Reduced astigmatism;
Improved vision;
Improved vision stability; and
Improved quality of life.
Response: It is important that companies consider all of the
various possibilities for new clinical advantages, and we appreciate
the range of potential issues that could be addressed through new IOL
technology. However, some significant questions remain. For example, it
could be that the incidence of some of these complications so low such
that it would be impossible to design a study to measure any
improvement due to a new IOL. It also could be that some surgical
complications could be the result of surgical technique that could not
be easily compensated for with a new IOL design. We also remind
stakeholders that innovations that provide greater surgeon convenience,
but no direct patient benefit, would not qualify for NTIOL status.
Also, vision improvements cannot be merely improved optical performance
but must relate to a meaningful improved outcome in visual performance.
The list of improved outcomes in the regulation is statutory and
therefore we are not modifying it. After consideration of the public
comments we received, we are adopting, without modification, our NTIOL
proposals.
7. Announcement of CY 2013 Deadline for Submitting Requests for CMS
Review of Appropriateness of ASC Payment for Insertion of an NTIOL
Following Cataract Surgery
In accordance with 42 CFR 416.185(a) of our regulations, CMS
announces that in order to be considered for payment effective January
1, 2014, requests for review of applications for a new class of new
technology IOLs must be received at CMS by 5 p.m. EST, on March 1,
2013. Send requests to ASC/NTIOL, Division of Outpatient Care, Mailstop
C4-05-17, Centers for Medicare and Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850. To be considered, requests for
NTIOL reviews must include the information requested on the CMS Web
site at: http://www.cms.gov/ASCPayment/downloads/NTIOLprocess.pdf.
F. ASC Payment and Comment Indicators
1. Background
In addition to the payment indicators that we introduced in the
August 2, 2007 final rule, we also created final comment indicators for
the ASC payment system in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66855). We created Addendum DD1 to define ASC payment
indicators that we use in Addenda AA and BB to provide payment
information regarding
[[Page 68462]]
covered surgical procedures and covered ancillary services,
respectively, under the revised ASC payment system. The ASC payment
indicators in Addendum DD1 are intended to capture policy relevant
characteristics of HCPCS codes that may receive packaged or separate
payment in ASCs, such as whether they were on the ASC list of covered
services prior to CY 2008; payment designation, such as device-
intensive or office-based, and the corresponding ASC payment
methodology; and their classification as separately payable ancillary
services including radiology services, brachytherapy sources, OPPS
pass-through devices, corneal tissue acquisition services, drugs or
biologicals, or NTIOLs.
We also created Addendum DD2 that lists the ASC comment indicators.
The ASC comment indicators used in Addenda AA and BB to the proposed
rules and final rules with comment period serve to identify, for the
revised ASC payment system, the status of a specific HCPCS code and its
payment indicator with respect to the timeframe when comments will be
accepted. The comment indicator ``NI'' is used in the OPPS/ASC final
rule with comment period to indicate new codes for the next calendar
year for which the interim payment indicator assigned is subject to
comment. The comment indicator ``NI'' is also assigned to existing
codes with substantial revisions to their descriptors such that we
consider them to be describing new services, as discussed in the CY
2010 OPPS/ASC final rule with comment period (74 FR 60622). In this CY
2013 OPPS/ASC final rule with comment period, we respond to public
comments and finalize the ASC treatment of all codes that are labeled
with comment indicator ``NI'' in Addenda AA and BB to the CY 2012 OPPS/
ASC final rule with comment period. These addenda can be found in a
file labeled ``January 2012 ASC Approved HCPCS Code and Payment Rates''
in the ASC Addenda Update section of the CMS Web site.
The ``CH'' comment indicator was used in Addenda AA and BB to the
CY 2013 OPPS/ASC proposed rule (which were available via the Internet
on the CMS Web site) to indicate that the payment indicator assignment
has changed for an active HCPCS code; an active HCPCS code is newly
recognized as payable in ASCs; or an active HCPCS code is discontinued
at the end of the current calendar year. The ``CH'' comment indicators
that are published in the final rule with comment period are provided
to alert readers that a change has been made from one calendar year to
the next, but do not indicate that the change is subject to comment.
2. ASC Payment and Comment Indicators
In the CY 2013 OPPS/ASC proposed rule (77 FR 45172), we did not
propose any changes to the definitions of the ASC payment and comment
indicators for CY 2013. We referred readers to Addenda DD1 and DD2 to
the CY 2013 OPPS/ASC proposed rule (which were available via the
Internet on the CMS Web site) for the complete list of ASC payment and
comment indicators proposed for the CY 2013 update.
We did not receive any public comments on the ASC payment and
comment indicators. Addenda DD1 and DD2 to this final rule with comment
period (which are available via the Internet on the CMS Web site)
contain the complete list of payment and commenter indicators for the
CY 2013 update.
G. ASC Policy and Payment Recommendations
MedPAC was established under section 1805 of the Act to advise
Congress on issues affecting the Medicare program. Subparagraphs (C)
and (D) of section 1805(b)(1) of the Act require MedPAC to submit
reports to Congress not later than March 15 and June 15 of each year
that present its Medicare payment policy reviews and recommendations
and its examination of issues affecting the Medicare program,
respectively. The March 2012 MedPAC ``Report to the Congress: Medicare
Payment Policy'' included the following recommendations relating
specifically to the ASC payment system for CY 2013:
Recommendation 5-1: ``The Congress should update the payment rates
for ambulatory surgical centers by 0.5 percent for calendar year 2013.
The Congress should also require ambulatory surgical centers to submit
cost data.''
Regarding the ASC payment update for CY 2013, MedPAC further stated
that: ``On the basis of our payment adequacy indicators, the lack of
ASC cost data, and our concerns about the potential effect of ASC
growth on overall program spending, we believe a moderate update of 0.5
percent is warranted for CY 2013.'' With regard to the collection of
cost data, MedPAC indicated that cost data are needed to fully assess
ASC payment adequacy under the revised ASC payment system and to
examine whether an alternative input price index would be an
appropriate proxy for ASC costs or whether an ASC-specific market
basket should be developed to annually update ASC payment rates.
CMS Response: We note that MedPAC's recommendation is for the
Congress to increase ASC payment rates by 0.5 percent in CY 2013 and
require ASCs to submit cost data. Congress has not yet acted on these
recommendations. In the CY 2013 OPPS/ASC proposed rule (77 FR 45172),
we proposed to continue our current policy to update the ASC conversion
factor using the CPI-U, and we did not propose to require ASCs to
submit cost data in the proposed rule. However, as discussed in section
XIV.H.2.b. of the proposed rule (77 FR 45174), while we believe the
CPI-U is appropriate to apply to update the ASC payment system, the
CPI-U may not best reflect inflation for the goods and services
provided by ASCs and, therefore, we sought public comment on the type
of cost information that would be feasible to collect from ASCs that
would assist us in determining possible alternatives to using the CPI-U
to update ASC payment rates for inflation. In section XIV.H.2.b. of
this final rule with comment period, we summarize and respond to the
public comments we received regarding the ASC update and the
feasibility of collecting ASC cost data.
H. Calculation of the ASC Conversion Factor and the ASC Payment Rates
1. Background
In the August 2, 2007 final rule (72 FR 42493), we established our
policy to base ASC relative payment weights and payment rates under the
revised ASC payment system on APC groups and the OPPS relative payment
weights. Consistent with that policy and the requirement at section
1833(i)(2)(D)(ii) of the Act that the revised payment system be
implemented so that it would be budget neutral, the initial ASC
conversion factor (CY 2008) was calculated so that estimated total
Medicare payments under the revised ASC payment system in the first
year would be budget neutral to estimated total Medicare payments under
the prior (CY 2007) ASC payment system (the ASC conversion factor is
multiplied by the relative payment weights calculated for many ASC
services in order to establish payment rates). That is, application of
the ASC conversion factor was designed to result in aggregate Medicare
expenditures under the revised ASC payment system in CY 2008 equal to
aggregate Medicare expenditures that would have occurred in CY 2008 in
the absence of the revised
[[Page 68463]]
system, taking into consideration the cap on ASC payments in CY 2007 as
required under section 1833(i)(2)(E) of the Act (72 FR 42522). We
adopted a policy to make the system budget neutral in subsequent
calendar years (72 FR 42532 through 42533).
We note that we consider the term ``expenditures'' in the context
of the budget neutrality requirement under section 1833(i)(2)(D)(ii) of
the Act to mean expenditures from the Medicare Part B Trust Fund. We do
not consider expenditures to include beneficiary coinsurance and
copayments. This distinction was important for the CY 2008 ASC budget
neutrality model that considered payments across the OPPS, ASC, and
MPFS payment systems. However, because coinsurance is almost always 20
percent for ASC services, this interpretation of expenditures has
minimal impact for subsequent budget neutrality adjustments calculated
within the revised ASC payment system.
In the CY 2008 OPPS/ASC final rule with comment period (72 FR 66857
through 66858), we set out a step-by-step illustration of the final
budget neutrality adjustment calculation based on the methodology
finalized in the August 2, 2007 final rule (72 FR 42521 through 42531)
and as applied to updated data available for the CY 2008 OPPS/ASC final
rule with comment period. The application of that methodology to the
data available for the CY 2008 OPPS/ASC final rule with comment period
resulted in a budget neutrality adjustment of 0.65.
For CY 2008, we adopted the OPPS relative payment weights as the
ASC relative payment weights for most services and, consistent with the
final policy, we calculated the CY 2008 ASC payment rates by
multiplying the ASC relative payment weights by the final CY 2008 ASC
conversion factor of $41.401. For covered office-based surgical
procedures and covered ancillary radiology services (excluding covered
ancillary radiology services involving certain nuclear medicine
procedures or involving the use of contrast agents, as discussed in
section XIV.D.2.b. of this final rule with comment period), the
established policy is to set the payment rate at the lower of the MPFS
unadjusted nonfacility PE RVU-based amount or the amount calculated
using the ASC standard ratesetting methodology. Further, as discussed
in the CY 2008 OPPS/ASC final rule with comment period (72 FR 66841
through 66843), we also adopted alternative ratesetting methodologies
for specific types of services (for example, device-intensive
procedures).
As discussed in the August 2, 2007 final rule (72 FR 42517 through
42518) and as codified at Sec. 416.172(c) of the regulations, the
revised ASC payment system accounts for geographic wage variation when
calculating individual ASC payments by applying the pre-floor and pre-
reclassified hospital wage indices to the labor-related share, which is
50 percent of the ASC payment amount. Beginning in CY 2008, CMS
accounted for geographic wage variation in labor cost when calculating
individual ASC payments by applying the pre-floor and pre-reclassified
hospital wage index values that CMS calculates for payment, using
updated Core Based Statistical Areas (CBSAs) issued by OMB in June
2003. The reclassification provision provided at section 1886(d)(10) of
the Act is specific to hospitals. We believe that using the most
recently available raw pre-floor and pre-reclassified hospital wage
indices results in the most appropriate adjustment to the labor portion
of ASC costs. In addition, use of the unadjusted hospital wage data
avoids further reductions in certain rural statewide wage index values
that result from reclassification. We continue to believe that the
unadjusted hospital wage indices, which are updated yearly and are used
by many other Medicare payment systems, appropriately account for
geographic variation in labor costs for ASCs.
We note that in certain instances there might be urban or rural
areas for which there is no IPPS hospital whose wage index data would
be used to set the wage index for that area. For these areas, our
policy has been to use the average of the wage indices for CBSAs (or
metropolitan divisions as applicable) that are contiguous to the area
that has no wage index (where ``contiguous'' is defined as sharing a
border). We have applied a proxy wage index based on this methodology
to ASCs located in CBSA 25980 Hinesville-Fort Stewart, GA, and CBSA 22
Rural Massachusetts.
In CY 2011, we identified another area, specifically, CBSA 11340
Anderson, SC for which there is no IPPS hospital whose wage index data
would be used to set the wage index for that area. Generally, we would
use the methodology described above; however, in this situation, all of
the areas contiguous to CBSA 11340 Anderson, SC are rural. Therefore,
in the CY 2011 OPPS/ASC final rule with comment period (75 FR 72058
through 72059), we finalized our proposal to set the ASC wage index by
calculating the average of all wage indices for urban areas in the
State when all contiguous areas to a CBSA are rural and there is no
IPPS hospital whose wage index data could be used to set the wage index
for that area. In other situations, where there are no IPPS hospitals
located in a relevant labor market area, we will continue our current
policy of calculating an urban or rural area's wage index by
calculating the average of the wage indices for CBSAs (or metropolitan
divisions where applicable) that are contiguous to the area with no
wage index.
Comment: Several commenters made the same recommendation that was
made in the CY 2010 (74 FR 60625), CY 2011 (75 FR 72059), and CY 2012
(76 FR 74446) rulemakings--that is, that CMS adopt for the ASC payment
system the same wage index values used for hospital payment under the
OPPS.
Response: We have responded to this comment in the past, and
believe our prior rationale for using unadjusted wage indices is still
a sound one. We continue to believe that the unadjusted hospital wage
indices, which are updated yearly and are used by almost all Medicare
payment systems, appropriately account for geographic variance in labor
costs for ASCs. We refer readers to our response to this comment in the
CY 2011 OPPS/ASC final rule with comment period (75 FR 72059). We
discuss our budget neutrality adjustment for changes to the wage
indices below in section XIV.H.2.b of this final rule with comment
period.
After consideration of the public comments we received, we are
continuing our established policy to account for geographic wage
variation in labor cost when calculating individual ASC payment by
applying the pre-floor and pre-reclassified hospital wage index values
that CMS calculated for payment, using updated CBSAs. For CY 2013, we
also are continuing our policy established in the CY 2011 OPPS/ASC
final rule with comment period (75 FR 72058 through 72059) to set the
ASC wage index by calculating the average of all wage indices for urban
areas in the state when there is no IPPS hospital whose wage index data
could be used to set the wage index for that area, and all contiguous
areas to the CBSA are rural.
2. Calculation of the ASC Payment Rates
a. Updating the ASC Relative Payment Weights for CY 2013 and Future
Years
We update the ASC relative payment weights each year using the
national OPPS relative payment weights (and MPFS nonfacility PE RVU-
based amounts, as applicable) for that same calendar year and uniformly
scale the ASC relative payment weights for each update year to make
them budget neutral (72 FR 42533). We note that, as
[[Page 68464]]
discussed in section II.A.2.f. of the CY 2013 OPPS/ASC proposed rule
(45094 through 45098) and in this final rule with comment period,
because we proposed to base the OPPS relative payment weights on
geometric mean costs for CY 2013, the ASC system would shift to the use
of geometric means to determine relative payment weights under the ASC
standard ratesetting methodology. Consistent with our established
policy, in the CY 2013 OPPS/ASC proposed rule (77 FR 45173), we
proposed to scale the CY 2013 relative payment weights for ASCs
according to the following method. Holding ASC utilization and the mix
of services constant from CY 2011, we proposed to compare the total
payment using the CY 2012 ASC relative payment weights with the total
payment using the CY 2013 relative payment weights to take into account
the changes in the OPPS relative payment weights between CY 2012 and CY
2013. We proposed to use the ratio of CY 2012 to CY 2013 total payment
(the weight scaler) to scale the ASC relative payment weights for CY
2013. The proposed CY 2013 ASC scaler was 0.9331 (77 FR 45174) and
scaling would apply to the ASC relative payment weights of the covered
surgical procedures and covered ancillary radiology services for which
the ASC payment rates are based on OPPS relative payment weights.
Scaling would not apply in the case of ASC payment for separately
payable covered ancillary services that have a predetermined national
payment amount (that is, their national ASC payment amounts are not
based on OPPS relative payment weights), such as drugs and biologicals
that are separately paid or services that are contractor-priced or paid
at reasonable cost in ASCs. Any service with a predetermined national
payment amount would be included in the ASC budget neutrality
comparison, but scaling of the ASC relative payment weights would not
apply to those services. The ASC payment weights for those services
without predetermined national payment amounts (that is, those services
with national payment amounts that would be based on OPPS relative
payment weights) would be scaled to eliminate any difference in the
total payment between the current year and the update year.
For any given year's ratesetting, we typically use the most recent
full calendar year of claims data to model budget neutrality
adjustments. At the time of the CY 2013 proposed rule, we had available
98 percent of CY 2011 ASC claims data. For this final rule with comment
period, we have approximately 99 percent of all ASC claims data for CY
2011.
To create an analytic file to support calculation of the weight
scaler and budget neutrality adjustment for the wage index (discussed
below), we summarized available CY 2011 ASC claims by ASC and by HCPCS
code. We used the National Provider Identifier for the purpose of
identifying unique ASCs within the CY 2011 claims data. We used the
supplier zip code reported on the claim to associate State, county, and
CBSA with each ASC. This file, available to the public as a supporting
data file for the proposed rule, is posted on the CMS Web site at:
http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/ASCPaymentSystem.html.
We did not receive any comments and, therefore, we are finalizing
our CY 2013 ASC relative payment weight scaling methodology, without
modification.
For this final rule with comment period, we used our proposed
methodology described above to calculate the scaler adjustment using
updated ASC claims data. The final CY 2013 scaler adjustment is 0.9324.
This scaler adjustment is necessary to make the difference in aggregate
ASC payments calculated using the CY 2012 ASC relative payment weights
and the CY 2013 relative payment weights budget neutral. We calculated
the difference in aggregate payments due to the change in relative
payment weights holding constant the ASC conversion factor, the most
recent CY 2011 ASC utilization from our claims data, and the CY 2012
wage index values. For this final CY 2013 calculation, we used the CY
2012 ASC conversion factor updated by the CY 2013 CPI-U, which is
projected to be 1.4 percent, less the multifactor productivity
adjustment of 0.8 percent, as discussed below in section XIV.H.2.b. of
this final rule with comment period.
b. Updating the ASC Conversion Factor
Under the OPPS, we typically apply a budget neutrality adjustment
for provider level changes, most notably a change in the wage index
values for the upcoming year, to the conversion factor. Consistent with
our final ASC payment policy, for the CY 2013 ASC payment system, in
the CY 2013 OPPS/ASC proposed rule (77 FR 45174), we proposed to
calculate and apply a budget neutrality adjustment to the ASC
conversion factor for supplier level changes in wage index values for
the upcoming year, just as the OPPS wage index budget neutrality
adjustment is calculated and applied to the OPPS conversion factor. For
CY 2013, we calculated this proposed adjustment for the ASC payment
system by using the most recent CY 2011 claims data available and
estimating the difference in total payment that would be created by
introducing the proposed CY 2013 pre-floor and pre-reclassified
hospital wage indices. Specifically, holding CY 2011 ASC utilization
and service-mix and the proposed CY 2013 national payment rates after
application of the weight scaler constant, we calculated the total
adjusted payment using the CY 2012 pre-floor and pre-reclassified
hospital wage indices and the total adjusted payment using the proposed
CY 2013 pre-floor and pre-reclassified hospital wage indices. We used
the 50-percent labor-related share for both total adjusted payment
calculations. We then compared the total adjusted payment calculated
with the CY 2012 pre-floor and pre-reclassified hospital wage indices
to the total adjusted payment calculated with the proposed CY 2013 pre-
floor and pre-reclassified hospital wage indices and applied the
resulting ratio of 1.0002 (the proposed CY 2013 ASC wage index budget
neutrality adjustment) to the CY 2012 ASC conversion factor to
calculate the proposed CY 2013 ASC conversion factor.
Section 1833(i)(2)(C)(i) of the Act requires that, ``if the
Secretary has not updated amounts established'' under the revised ASC
payment system in a calendar year, the payment amounts ``shall be
increased by the percentage increase in the Consumer Price Index for
all urban consumers (U.S. city average) as estimated by the Secretary
for the 12-month period ending with the midpoint of the year
involved.'' The statute, therefore, does not mandate the adoption of
any particular update mechanism, but it requires the payment amounts to
be increased by the CPI-U in the absence of any update. Because the
Secretary updates the ASC payment amounts annually, we adopted a
policy, which we codified at 42 CFR 416.171(a)(2)(ii), to update the
ASC conversion factor using the CPI-U for CY 2010 and subsequent
calendar years. Therefore, the annual update to the ASC payment system
is the CPI-U (referred to as the CPI-U update factor).
Stakeholders, as well as MedPAC, have commented throughout the
years that the CPI-U may not adequately measure inflation for the goods
and services provided by ASCs (for example, 76 FR 74444, 74448 through
74450; 73 FR 68757; and 72 FR 66859). While we believe the CPI-U is
appropriate to apply to update the ASC payment
[[Page 68465]]
system, we are aware that the CPI-U is highly weighted for housing and
transportation and may not best reflect inflation in the cost of
providing ASC services. In developing the CY 2013 OPPS/ASC proposed
rule, we considered possible alternatives to using the CPI-U to update
ASC payment rates for inflation.
ASC stakeholders have urged us to adopt the hospital market basket
to update ASC payment rates for inflation when commenting on each
proposed rule since the beginning of the revised ASC payment system (72
FR 66859; 73 FR 68757; 74 FR 60628 through 60629; 75 FR 72063; and 76
FR 74449). We considered the hospital market basket as an alternative
to the CPI-U and, while the items included in the hospital market
basket seem reflective of the kinds of costs incurred by ASCs, as
stated in the CY 2012 OPPS/ASC final rule with comment period, we
believe that the hospital market basket does not align with the cost
structures of ASCs. A much wider range of services, such as room and
board and emergency services, are provided by hospitals but are not
reflective of costs associated with providing services in ASCs (76 FR
74450). As other possible alternatives to the CPI-U update, we
considered using the physician's practice expense (PE) component of the
Medicare Economic Index (MEI) update, as well as using an average of
the hospital market basket update and the PE component of the MEI
update. However, until we have more information regarding the cost
inputs of ASCs, we are not confident that any of these alternatives are
a better proxy for ASC costs than the CPI-U. Therefore, in the CY 2013
OPPS/ASC proposed rule (77 FR 45174), we proposed a continuation of the
established policy of basing the ASC update on the CPI-U. In addition,
we requested public comment on the type of cost information that would
be feasible to collect from ASCs in the future in order to determine if
one of these alternative updates or an ASC-specific market basket would
be a better proxy for ASC cost inflation than the CPI-U.
Section 3401(k) of the Affordable Care Act amended section
1833(i)(2)(D) of the Act by adding a new clause (v) which requires that
``any annual update under [the ASC payment] system for the year, after
application of clause (iv), shall be reduced by the productivity
adjustment described in section 1886(b)(3)(B)(xi)(II)'' of the Act
effective with the calendar year beginning January 1, 2011. The statute
defines the productivity adjustment to be equal to the 10-year moving
average of changes in annual economy-wide private nonfarm business
multifactor productivity (MFP) (as projected by the Secretary for the
10-year period ending with the applicable fiscal year, year, cost
reporting period, or other annual period) (the ``MFP adjustment'').
Clause (iv) of section 1833(i)(2)(D) of the Act authorizes the
Secretary to provide for a reduction in any annual update for failure
to report on quality measures. Clause (v) of section 1833(i)(2)(D) of
the Act states that application of the MFP adjustment to the ASC
payment system may result in the update to the ASC payment system being
less than zero for a year and may result in payment rates under the ASC
payment system for a year being less than such payment rates for the
preceding year.
In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74516), we finalized a policy that ASCs begin submitting data on
quality measures for services beginning on October 1, 2012 for the CY
2014 payment determination under the ASCQR Program. Section XVI.D. of
the CY 2013 OPPS/ASC proposed rule (77 FR 45192 through 45193) provided
a discussion of the proposed payment reduction to the annual update for
ASCs that fail to meet the ASCQR Program requirements. In summary, we
proposed to calculate reduced national unadjusted payment rates using
the ASCQR Program reduced update conversion factor that would apply to
ASCs that fail to meet their quality reporting requirements. The
reduced rates would apply beginning in CY 2014. We proposed that
application of the 2.0 percentage point reduction to the annual update
factor, which currently is the CPI-U, may result in the update to the
ASC payment system being less than zero for a year for ASCs that fail
to meet the ASCQR Program requirements. We proposed changes to
Sec. Sec. 416.160(a)(1) and 416.171 to reflect this proposal. Comments
to this proposal are addressed in section XVI.D.2 of this final rule
with comment period.
In accordance with section 1833(i)(2)(C)(i) of the Act, before
applying the MFP adjustment, the Secretary first determines the
``percentage increase'' in the CPI-U, which we interpret cannot be a
negative number. Thus, in the instance where the percentage change in
the CPI-U for a year is negative, we would hold the CPI-U update factor
for the ASC payment system to zero. For the CY 2014 payment
determination and subsequent payment determination years, under section
1833(i)(2)(D)(iv) of the Act, we would reduce the annual update by 2.0
percentage points for an ASC that fails to submit quality information
under the rules established by the Secretary in accordance with section
1833(i)(7) of the Act. Section 1833(i)(2)(D)(v) of the Act, as added by
section 3401(k) of the Affordable Care Act, requires that the Secretary
reduce the annual update factor, after application of any quality
reporting reduction by the MFP adjustment, and states that application
of the MFP adjustment may reduce this percentage change below zero. If
the application of the MFP adjustment to the annual update factor after
application of any quality reporting reduction would result in an MFP-
adjusted update factor that is less than zero, the resulting update to
the ASC payment rates would be negative and payments would decrease
relative to the prior year. Illustrative examples of how the MFP
adjustment would be applied to the ASC payment system update are found
in the CY 2011 OPPS/ASC final rule with comment period (75 FR 72062
through 72064).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45175), for the 12-
month period ending with the midpoint of CY 2013, the CPI-U update was
projected to be 2.2 percent. Because the ASCQR Program does not affect
payment rates until CY 2014, there would be no quality reporting
reduction to the CPI-U for CY 2013. The MFP adjustment for the period
ending with the midpoint of CY 2013 was projected to be 0.9 percent
based on the methodology for calculating the MFP adjustment finalized
in the CY 2011 MPFS final rule with comment period (75 FR 73394 through
73396) as revised in the CY 2012 MPFS final rule with comment period
(76 FR 73300 through 73301). We proposed to reduce the CPI-U update of
2.2 percent by the MFP adjustment of 0.9 percent, resulting in an MFP-
adjusted CPI-U update factor of 1.3 percent. Therefore, as stated in
the CY 2013 OPPS/ASC proposed rule (77 FR 45175), we proposed to apply
a 1.3 percent MFP-adjusted CPI-U update factor to the CY 2012 ASC
conversion factor.
For CY 2013, we also proposed to adjust the CY 2012 ASC conversion
factor ($42.627) by the wage adjustment for budget neutrality of 1.0002
in addition to the MFP-adjusted update factor of 1.3 percent discussed
above, which resulted in a proposed CY 2013 ASC conversion factor of
$43.190 (77 FR 45175). We invited public comments on these proposals.
Comment: Commenters expressed varied opinions regarding the
feasibility of requiring ASCs to submit cost data to the Secretary. One
commenter believes that CMS should require ASCs to submit
[[Page 68466]]
cost data so that an appropriate market basket for ASC annual updates
can be identified and so that analysts can determine the costs of an
efficient provider of ASC services. The commenter believes that
reporting such data is feasible because businesses such as ASCs
typically keep record of their costs for filing taxes and other
purposes. In addition, this commenter pointed out that other small
providers, including home health agencies and hospices, submit cost
data to CMS.
Other commenters (predominantly commenters who represent ASCs)
opposed a requirement that ASCs submit cost data to CMS. The commenters
believed that a requirement to submit cost data would be both
unnecessary and administratively burdensome for ASCs.
Further, some commenters stated that requiring ASCs to submit cost
data that would not be directly tied to receipt of payment would likely
result in the submission of data that is unreliable. These commenters
also maintained that using cost data to develop an ASC-specific market
basket would not provide a more accurate reflection of ASC cost growth.
Commenters believed that creating a single set of cost weights that are
representative of the industry average would relate to few ASCs as most
centers are specialized and would have a cost structure that is
specific to the procedures they provide. These commenters also stated
that, by CMS' own description, the hospital market basket itself is an
imperfect measure of hospital outpatient costs but CMS has rationalized
use of the hospital market basket as the best available measure of
costs in the hospital outpatient setting. The commenters believe that,
likewise, the best available proxy to measure costs in the ASC setting
is the hospital market basket. Commenters expressed frustration that
CMS has not adopted the hospital market basket to update ASC payment
rates and urged the agency to not waste precious resources collecting
ASC cost data when this reasonable measure of input prices is readily
available.
Response: We thank all of the commenters for their thoughts
regarding the type of cost information that would be feasible to
collect from ASCs in the future in order to determine if an alternative
update or an ASC-specific market basket would be a better proxy for ASC
cost inflation compared to the CPI-U. We will keep the commenters'
perspectives about collecting cost information from ASCs in mind as we
consider this issue further.
Comment: As in previous years, commenters requested that CMS adopt
the hospital market basket to update the ASC payment system instead of
using the CPI-U. The commenters explained that the CPI-U does not
fairly represent the costs borne by the ASC industry because the prices
measured in the basket of goods comprising the index reflect the types
and weights of categories typical of an American household, rather than
an outpatient surgical provider. Commenters believed that the hospital
market basket more closely reflects the cost structure of ASCs than
does the basket of goods included in the CPI-U. Commenters stated that
adopting the hospital market basket to update ASC payment rates would
minimize the divergence in CY 2013 payments in ASCs compared to HOPDs
and would ensure continued beneficiary access to ASCs.
Commenters also indicated that the hospital market basket is a more
appropriate index to use for the ASC update now that CMS is required to
apply the MFP adjustment to the ASC annual update. Commenters stated
that, as an output price index, the CPI-U index already accounts for
productivity thus ASCs, in essence, are receiving a productivity
adjustment that is twice that applied to the HOPD update. Because CMS
has discretion regarding the index used to update ASCs, but is required
in statute to adjust the ASC update by the MFP, commenters urged CMS to
use the hospital market basket, which is an input price index that does
not already account for productivity, to update ASC payment rates and
thereby allow the appropriate application of the required productivity
adjustment. Commenters also requested that the 10-year MFP measurement
period be uniform in ASCs and HOPDs so that there is no discrepancy in
the estimates of the MFP that will provide additional divergence
between the ASC and HOPD updates.
Response: While commenters argue that the items included in the
CPI-U index may not adequately measure inflation for the goods and
services provided by ASCs and that use of the hospital market basket
would minimize the divergence in the payment rates between the OPPS and
ASC payment system, we believe that the hospital market basket does not
align with the cost structures of ASCs. Hospitals provide a much wider
range of services, such as room and board and emergency services, and
the costs associated with providing these services are not part of the
ASC cost structure. Therefore, at this time, we do not believe that it
is appropriate to use the hospital market basket for the ASC annual
update.
We recognize that the CPI-U is an output price index that accounts
for productivity. However, section 1833(i)(2)(D)(v) of the Act requires
the agency to reduce the annual update factor by the MFP adjustment.
For the reasons stated above, we do not believe that the hospital
market basket would appropriately reflect the cost structures of ASCs,
and because we do not have cost data on ASCs, we are not able to
recommend a more accurate update. Therefore, the CPI-U remains the most
appropriate update. Regarding alignment of the MFP adjustment across
payment systems, for reasons stated in the CY 2011 MPFS final rule with
comment period (75 FR 73396), we believe that it is more appropriate to
align the MFP adjustment with the update timeframes for each payment
system rather than aligning the MFP adjustment across payment systems.
After consideration of the public comments we received, we are
applying our established methodology for determining the final CY 2013
ASC conversion factor. Using more complete CY 2011 data for this final
rule with comment period than was available for the proposed rule, we
calculated a wage index budget neutrality adjustment of 1.0008. Based
on updated data, the CPI-U for the 12-month period ending with the
midpoint of CY 2013 is now projected to be 1.4 percent, while the MFP
adjustment (using the revised IGI series to proxy the labor index used
in the MFP forecast calculation as discussed and finalized in the CY
2012 MPFS final rule with comment period) is 0.8 percent, resulting in
an MFP-adjusted CPI-U update factor of 0.6 percent. The final ASC
conversion factor of $42.917 is the product of the CY 2012 conversion
factor of $42.627 multiplied by the wage index budget neutrality
adjustment of 1.0008 and the MFP-adjusted CPI-U payment update of 0.6
percent. We also are finalizing proposed changes to Sec. Sec.
416.160(a)(1) and 416.171, without modification, regarding the
reduction to payment rates beginning in CY 2014 for ASCs that fail to
meet the ASCQR Program requirements.
3. Display of CY 2013 ASC Payment Rates
Addenda AA and BB to this CY 2013 OPPS/ASC final rule with comment
period (which are available via the Internet on the CMS Web site)
display the final updated ASC payment rates for CY 2013 for covered
surgical procedures and covered ancillary services, respectively. These
addenda contain several types of information related to the CY 2013
payment rates. Specifically,
[[Page 68467]]
in Addendum AA, a ``Y'' in the column titled ``Subject to Multiple
Procedure Discounting'' indicates that the surgical procedure will be
subject to the multiple procedure payment reduction policy. As
discussed in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66829 through 66830), most covered surgical procedures are subject to a
50-percent reduction in the ASC payment for the lower-paying procedure
when more than one procedure is performed in a single operative
session. Display of the comment indicator ``CH'' in the column titled
``Comment Indicator'' indicates a change in payment policy for the item
or service, including identifying discontinued HCPCS codes, designating
items or services newly payable under the ASC payment system, and
identifying items or services with changes in the ASC payment indicator
for CY 2013. Display of the comment indicator ``NI'' in the column
titled ``Comment Indicator'' indicates that the code is new (or
substantially revised) and that the payment indicator assignment is an
interim assignment that is open to comment in this final rule with
comment period.
The values displayed in the column titled ``CY 2013 Payment
Weight'' are the relative payment weights for each of the listed
services for CY 2013. The payment weights for all covered surgical
procedures and covered ancillary services whose ASC payment rates are
based on OPPS relative payment weights were scaled for budget
neutrality. Thus, scaling was not applied to the device portion of the
device-intensive procedures, services that are paid at the MPFS
nonfacility PE RVU-based amount, separately payable covered ancillary
services that have a predetermined national payment amount, such as
drugs and biologicals and brachytherapy sources that are separately
paid under the OPPS, or services that are contractor-priced or paid at
reasonable cost in ASCs.
To derive the CY 2013 payment rate displayed in the ``CY 2013
Payment'' column, each ASC payment weight in the ``CY 2013 Payment
Weight'' column was multiplied by the CY 2013 conversion factor of
$42.917. The conversion factor includes a budget neutrality adjustment
for changes in the wage index values and the annual update factor as
reduced by the productivity adjustment (as discussed in section
XIV.H.2.b. of this final rule with comment period).
In Addendum BB, there are no relative payment weights displayed in
the ``CY 2013 Payment Weight'' column for items and services with
predetermined national payment amounts, such as separately payable
drugs and biologicals. The ``CY 2013 Payment'' column displays the CY
2013 national unadjusted ASC payment rates for all items and services.
The CY 2013 ASC payment rates listed in Addendum BB for separately
payable drugs and biologicals are based on ASP data used for payment in
physicians' offices in October 2012.
Addendum EE provides the HCPCS codes and short descriptors for
surgical procedures that are to be excluded from payment in ASCs for CY
2013.
We did not receive any public comments regarding the continuation
of our policy to provide CY 2013 ASC payment information as detailed in
Addenda AA and BB. Therefore, Addenda AA and BB to this final rule with
comment period (which are available via the Internet on the CMS Web
site) display the updated ASC payment rates for CY 2013 for covered
surgical procedures and covered ancillary services, respectively, and
provide additional information related to the CY 2013 rates.
XV. Hospital Outpatient Quality Reporting Program Updates
A. Background
1. Overview
CMS has implemented quality measure reporting programs for multiple
settings of care. These programs promote higher quality, more efficient
health care for Medicare beneficiaries. The quality data reporting
program for hospital outpatient care, known as the Hospital Outpatient
Quality Reporting (Hospital OQR) Program, formerly known as the
Hospital Outpatient Quality Data Reporting Program (HOP QDRP), has been
generally modeled after the quality data reporting program for hospital
inpatient services known as the Hospital Inpatient Quality Reporting
(Hospital IQR) Program (formerly known as the Reporting Hospital
Quality Data for Annual Payment Update (RHQDAPU) Program). Both of
these quality reporting programs for hospital services have financial
incentives for the reporting of quality data to CMS.
CMS also has implemented quality reporting programs for long term
care hospitals, inpatient rehabilitation hospitals, the hospice
program, ambulatory surgical centers (the Ambulatory Surgical Center
Quality Reporting (ASCQR) Program), as well as a program for physicians
and other eligible professionals, known as the Physician Quality
Reporting System (PQRS) (formerly known as the Physician Quality
Reporting Initiative (PQRI)). CMS has recently finalized quality
reporting programs for inpatient psychiatric facilities and PPS-exempt
cancer hospitals.
Finally, CMS has implemented a Hospital Value-Based Purchasing
Program and an end-stage renal disease (ESRD) Quality Incentive Program
(76 FR 628 through 646) that link payment to performance.
In implementing the Hospital OQR Program and other quality
reporting programs, we have focused on measures that have high impact
and support national priorities for improved quality and efficiency of
care for Medicare beneficiaries as reflected in the National Quality
Strategy, as well as conditions for which wide cost and treatment
variations have been reported, despite established clinical guidelines.
Our ultimate goal is to align the clinical quality measure requirements
of the Hospital OQR Program and various other programs, such as the
Hospital IQR Program, the ASCQR Program, and the Medicare and Medicaid
Electronic Health Record (EHR) Incentive Programs, authorized by the
Health Information Technology for Economic and Clinical Health Act, so
that the burden for reporting will be reduced. As appropriate, we will
consider the adoption of measures with electronic specifications, to
enable the collection of this information as part of care delivery.
Establishing such an alignment will require interoperability between
electronic health records (EHRs), and CMS data collection systems, with
data being calculated and submitted via certified EHR technology;
additional infrastructural development on the part of hospitals and
CMS; and the adoption of standards for capturing, formatting, and
transmitting the data elements that make up the measures. Once these
activities are accomplished, the adoption of many measures that rely on
data obtained directly from EHRs will enable us to expand the Hospital
OQR Program measure set with less cost and burden to hospitals.
In implementing this and other quality reporting programs, we
generally applied the same principles for the development and the use
of measures, with some differences:
Our overarching goal is to support the National Quality
Strategy's goal of better health care for individuals, better health
for populations, and lower costs for health care. The Hospital OQR
Program will help achieve these goals by creating transparency around
the quality of care at hospital outpatient departments to support
patient decision-making and quality
[[Page 68468]]
improvement. Given the availability of well validated measures and the
need to balance breadth with minimizing burden, measures should take
into account and address, as fully as possible, the six domains of
measurement that arise from the six priorities of the National Quality
Strategy: Clinical care; Person- and caregiver-centered experience and
outcomes; Safety; Efficiency and cost reduction; Care coordination; and
Community/population health. More information regarding the National
Quality Strategy can be found at: http://www.healthcare.gov/law/resources/reports/. HHS engaged a wide range of stakeholders to develop
the National Quality Strategy, as required by the Affordable Care Act.
Pay-for-reporting and public reporting should rely on a
mix of standards, processes, outcomes, efficiency, and patient
experience of care measures, including measures of care transitions and
changes in patient functional status.
To the extent possible and recognizing differences in
payment system maturity and statutory authorities, measures should be
aligned across Medicare and Medicaid public reporting and incentive
payment systems to promote coordinated efforts to improve quality. The
measure sets should evolve so that they include a focused set of
measures appropriate to the specific provider category that reflects
the level of care and the most important areas of service and measures
for that provider category.
We weigh the relevance and the utility of measures
compared to the burden on hospitals in submitting data under the
Hospital OQR Program. The collection of information burden on providers
should be minimized to the extent possible. To this end, we are working
toward the eventual adoption of electronically-specified measures so
that data can be calculated and submitted via certified EHR technology
with minimal burden. We also seek to use measures based on alternative
sources of data that do not require chart abstraction or that utilize
data already being reported by many hospitals, such as data that
hospitals report to clinical data registries, or all-payer claims
databases. In recent years we have adopted measures that do not require
chart abstraction, including structural measures and claims-based
measures that we can calculate using other data sources.
To the extent practicable and feasible, and recognizing
differences in statutory authorities, measures used by CMS should be
endorsed by a national, multi-stakeholder organization. We take into
account the views of the Measure Application Partnership (MAP). The MAP
is a public-private partnership convened by the National Quality Forum
(NQF) for the primary purpose of providing input to HHS on selecting
performance measures for quality reporting programs and pay for
reporting programs. The MAP views patient safety as a high priority
area and it strongly supports the use of NQF-endorsed safety measures.
Accordingly, we consider the MAP's recommendations in selecting quality
and efficiency measures. Information about the MAP can be found at
http://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx
Measures should be developed with the input of providers,
purchasers/payers, consumers, and other stakeholders. Measures should
be aligned with best practices among other payers and the needs of the
end users of the measures. We take into account widely accepted
criteria established in medical literature.
HHS Strategic Plan and Initiatives. HHS is the U.S.
government's principal agency for protecting the health of all
Americans. HHS accomplishes its mission through programs and
initiatives. Every 4 years HHS updates its Strategic Plan and measures
its progress in addressing specific national problems, needs, or
mission-related challenges. The goals of the HHS Strategic Plan for
Fiscal Years 2010 through 2015 are to: Transform Health Care; Advance
Scientific Knowledge and Innovation; Advance the Health, Safety, and
Well-Being of the American People; Increase Efficiency, Transparency,
and Accountability of HHS Programs; and Strengthen the Nation's Health
and Human Services Infrastructure and Workforce (http://www.hhs.gov/about/FY2012budget/strategicplandetail.pdf). HHS prioritizes policy and
program interventions to address the leading causes of death and
disability in the United States, including heart disease, cancer,
stroke, chronic lower respiratory diseases, unintentional injuries and
preventable behaviors. Initiatives such as the HHS Action Plan to
Reduce Healthcare-associated Infections (HAIs) in clinical settings and
the Partnership for Patients exemplify these programs.
CMS Strategic Plan. We strive to ensure that measures for
different Medicare and Medicaid programs are aligned with priority
quality goals, that measure specifications are aligned across settings,
that outcome measures are used whenever possible, and that quality
measures are collected from EHRs as appropriate.
In the CY 2012 OPPS/ASC final rule with comment period (76 FR 74451
through 74452), we responded to public comment on many of these
principles. In the CY 2013 OPPS/ASC proposed rulemaking, we generally
applied the same principals for our considerations for future measures,
with some differences.
Comment: Many commenters supported CMS' general principles of
measure development, selection, and implementation, specifically, CMS'
combined approach of using process and outcomes measures, as well as
our intent to adopt NQF-endorsed measures whenever feasible, and to
align measures across settings under different quality reporting
programs. One commenter stated that CMS should only adopt measures that
are useful for hospital outpatient departments to improve their quality
performance.
A few commenters recommended that the Hospital OQR Program only
adopt NQF-endorsed measures which undergo established sound, and timely
measure maintenance and update procedures. Several commenters urged
that CMS proceed cautiously when considering adopting non-NQF-endorsed
measures, which in some cases may not have been rigorously field-tested
and may end up in subsequent suspension or implementation deferral.
Commenters requested that CMS delay adoption of measures in the future
until specification problems are completely ironed out so that
hospitals do not have to spend resources on preparing for incompletely
specified or untested measures.
Response: As discussed, we usually focus on measures appropriate to
the specific provider category that reflect the level of care and the
most important areas of service and measures for that provider
category. Section 1833(t)(17)(C)(i) of the Act requires the Secretary
to ``develop measures that the Secretary determines to be appropriate
for the measurement of the quality of care (including medication
errors) furnished by hospitals in outpatient settings and that reflect
consensus among affected parties and, to the extent feasible and
practicable, shall include measures set forth by one or more national
consensus building entities.'' This provision does not require that the
measures we adopt for the Hospital OQR Program be endorsed by any
particular entity, and we believe that consensus among affected parties
can be achieved by means other than endorsement by a national consensus
building entity, including through the
[[Page 68469]]
measure development process, through broad acceptance and use of the
measure(s), and through public comment.
Generally, we prefer to adopt NQF-endorsed measures. We rely on NQF
to endorse only those measures that have met the rigorous field testing
requirement and we do not re-test these measures prior to adoption.
However, in some circumstances, as with OP-19, when we find the
specifications require revision after the measure has been adopted, CMS
chooses to suspend a measure rather than requiring continued data
collection to alleviate burden on hospitals.
We strive to field test each measure we use in our programs.
However, on rare occasions, we adopt measures that were developed and
tested by other measure stewards. With respect to the commenters who
recommended that, in the future, we delay adoption of measures until
specification problems are completely resolved so that hospitals would
not have to spend resources on preparing for incompletely specified or
untested measures, we believe the commenters may have been referring
specifically to one measure-- OP-24: Cardiac Rehabilitation Patient
Referral from an Outpatient Setting. For that measure, we are delaying
data collection until January 1, 2014, and its application toward a
payment determination will be for CY 2015 rather than CY 2014. If our
interpretation of the comment was correct, we understand the
commenter's concerns. However, we clarify that because we have not
added any OP-24 measure specifications to the Specification Manual yet,
it is highly unlikely that hospitals would have spent resources in
preparing for this measure.
In instances where we develop our measures, we do proceed with
caution, employing a rigorous consensus-based measure development and
field testing process that incorporates broad stakeholder input.
Therefore, we believe it is reasonable to adopt measures developed in
this manner whether or not they achieve NQF endorsement. For those
measures that we have not developed, we strive to obtain testing
information on the technical aspects from the developer and to work
with the developer to create specifications that enable standardized
collection in national programs. In the case of measures we do not
develop, the above specification process may occur after adoption of
the measure in a reporting program, but prior to implementing data
collection.
Comment: Some commenters supported CMS' goal to align measures in
the Hospital IQR, Hospital OQR, and Medicare and Medicaid EHR Incentive
Programs. Commenters also commended CMS for striving for quality
reporting that is based upon meaningful and comparable measures.
Response: We thank the commenters for supporting our strategy to
align measures across settings and programs whenever feasible and to
move toward more meaningful measures in our programs.
2. Statutory History of the Hospital Outpatient Quality Reporting
(Hospital OQR) Program
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72064) for a detailed discussion of the statutory history
of the Hospital OQR Program.
3. Measure Updates and Data Publication
a. Process for Updating Quality Measures
Technical specifications for the Hospital OQR Program measures are
listed in the Hospital OQR Specifications Manual, which is posted on
the CMS QualityNet Web site at: http://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FSpecsManualTemplate&cid=1228772438492.
We maintain the technical specifications for the measures by
updating this Hospital OQR Specifications Manual and including detailed
instructions and calculation algorithms. In some cases where the
specifications are available elsewhere, we may include links to Web
sites hosting technical specifications. These resources are for
hospitals to use when collecting and submitting data on required
measures.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68766
through 68767), we established an additional subregulatory process for
making updates to the measures we have adopted for the Hospital OQR
Program. This process is necessary so that the Hospital OQR measures
are calculated based on the most up-to-date scientific and consensus
standards. Under this process, when a national consensus building
entity updates the specifications for a measure that we have adopted
for the Hospital OQR Program, we update our specifications for that
measure accordingly. For measures that are not endorsed by a national
consensus building entity, the subregulatory process is based on
scientific advances as determined necessary by CMS, in part, through
our measure maintenance process involving Technical Expert Panels (73
FR 68767). We provide notice of the updates via the QualityNet Web
site, http://www.QualityNet.org, and in the Hospital OQR Specifications
Manual.
We generally release the Hospital OQR Specifications Manual every 6
months and release addenda as necessary. This release schedule provides
at least 3 months of advance notice for nonsubstantive changes such as
changes to ICD-9, CPT, NUBC, and HCPCS codes, and at least 6 months of
advance notice for changes to data elements that would require
significant systems changes.
Comment: One commenter believed that conversion of measures to use
ICD-10-CM/PCS and eMeasure formats should be considered a substantial
change and should warrant the proposed rulemaking process. One
commenter asserted that there are shortcomings in the CMS subregulatory
process. The commenter was concerned that this rapid subregulatory
process may not include a field review of the measure. Secondly, the
commenter stated that some measure changes affect data accuracy and
completeness, such as change of diagnosis, procedure codes and changes
to exclusions to the patient population and extended application of the
measure to other hospital locations. The commenter believed that these
are substantive changes rather than non-substantive changes as noted by
CMS.
Response: We will be transitioning all of our billing and
measurement systems from ICD-9 to ICD-10. We intend to solicit public
comment on the ICD-10 versions of our measure specifications through
future rulemaking prior to implementation. We normally incorporate
coding updates for the measures using our established subregulatory
process because such updates do not change the basic underlying
concepts being measured. This is theoretically true of moving from ICD-
9 to the ICD-10 coding system (or eMeasure format). However, we
recognize that in moving to ICD-10 coding (or eMeasure format) there
may be some nuances in the measures that when translated result in
unanticipated differences in performance, rendering prior measure
results untrendable with results for the same measures under the new
coding system. We also intend to study this effect further once
implementation has occurred and data are available to do so.
In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53504), we indicated
that examples of what we might generally regard as nonsubstantive
changes to measures might include updated
[[Page 68470]]
diagnosis or procedure codes, medication updates for categories of
medications, or a broadening of age ranges. We believe that
nonsubstantive changes may also include updates to NQF-endorsed
measures based upon changes to guidelines upon which the measures are
based. We note that the NQF process has already incorporated an
opportunity for public comment and engagement in the measure
maintenance process.
We will continue to use rulemaking to adopt substantive updates
made by the NQF to the endorsed measures we have adopted for the
Hospital OQR Program. Examples of changes that we might generally
consider to be substantive would be those in which the changes are so
significant that the measure is no longer the same measure, or when a
standard of performance assessed by a measure becomes more stringent
(for example, changes in acceptable timing of medication, NQF expansion
of endorsement of a previously endorsed measure to a new setting,
procedure/process, or test administration). However, these and other
changes would need to be evaluated on a case-by-case basis to determine
whether or not a change to a measure is in fact substantive.
Comment: A few commenters expressed concern that the CMS procedures
for notifying providers of significant changes to quality measures and
general changes to the Hospital OQR Program may be problematic at
times, as email blasts, one of the CMS communication methods, do not
always reach the appropriate quality measure personnel. The commenters
requested consistency in transparency of CMS' communications to
hospitals, vendors, and QIOs and requested sufficient notice be given
to hospitals regarding the new start date of any measure changes.
Response: We thank these commenters for feedback on communication.
We endeavor to communicate clearly to all Hospital OQR Program
stakeholders. We offer email blasts to subscribers who sign up to
receive them, indicating they prefer to receive information by email.
The QualityNet Web site contains a full list of all email blasts sent,
and it is available for any stakeholder to review at any time. We do
not intend the listserv to replace QualityNet as the primary source for
information and resources for the Hospital OQR Program.
We offer a helpline that is available weekdays to offer technical
support and assistance to callers, in an effort to help any caller
successfully comply with program requirements. Please find this
helpline and program contact information by visiting the QualityNet Web
site at https://www.qualitynet.org. From this page, choose ``Hospitals-
Outpatient'' from the drop down menus across the top of the page, then
click on ``Support Contact.''
Comment: A few commenters appreciated the 6-month advance notice of
data elements and system changes but noted that the 6-month period for
measure update and Specifications Manual release may not provide
sufficient time for hospitals to make changes in data elements and
system. Another commenter requested more detailed instructions on chart
abstraction be provided because the training Qs and As posted on the
QualityNet Web site are insufficient and appear to contradict the
Specifications Manual at times.
Response: Our experience with this and other quality reporting
programs indicates that 6 months' notice is sufficient for hospitals
and their vendors to accommodate data element and system changes. We
provide detailed abstraction instructions in our measure Specifications
Manual, and provide additional guidance through Qs and As posted on the
QualityNet Web site, and by offering periodic training.
We will take into consideration the recommendation to provide more
detailed instructions on chart abstraction due to insufficient Qs and
As posted on the QualityNet Web site. We are aware of a specific
situation we corrected earlier this year. Under the ED Throughput
topic, we had two contradictory answers posted within our Qs and As for
a brief period. We have corrected the situation and we apologize for
the confusion it may have caused.
We will address this comment by having our primary support
contractor review the current and incoming Qs and As to look for
opportunities to incorporate answers into the Specifications Manual
where appropriate. We strive to maintain high quality Qs and As that
stakeholders can use as a reference for chart abstraction and measure
specifications.
b. Publication of Hospital OQR Program Data
Section 1833(t)(17)(E) of the Act requires that the Secretary
establish procedures to make data collected under the Hospital OQR
Program available to the public. It also states that such procedures
must ensure that a hospital has the opportunity to review the data that
are to be made public, with respect to the hospital prior to such data
being made public. To meet these requirements, data that a hospital has
submitted for the Hospital OQR Program are typically provided to
hospitals for a preview period via QualityNet, and then displayed on
CMS Web sites such as the Hospital Compare Web site, http://www.hospitalcompare.hhs.gov following the preview period. The Hospital
Compare Web site is an interactive Web tool that assists beneficiaries
by providing information on hospital quality of care. We believe this
information motivates beneficiaries to work with their doctors and
hospitals to discuss the quality of care hospitals provide to patients,
thus providing additional incentives to hospitals to improve the
quality of care that they furnish.
Under our current policy, we publish quality data by the
corresponding hospital CMS Certification Number (CCN), and indicate
instances where data from two or more hospitals are combined to form
the publicly reported measures on the Hospital Compare Web site. That
is, in a situation in which a larger hospital has taken over ownership
of a smaller hospital, the smaller hospital's CCN will be replaced by
the larger hospital's CCN (the principal CCN). For data display
purposes, we will only display data received under the principal CCN.
If both hospitals are submitting data, those data are not
distinguishable in the warehouse; and the data is calculated together
as one hospital.
Consistent with our current policy, we make Hospital IQR and
Hospital OQR data publicly available whether or not the data have been
validated for payment purposes. The Hospital Compare Web site currently
displays information covering process of care, structural, ED
throughput timing, health IT, and imaging efficiency measure data under
the Hospital OQR Program.
In general, we strive to display hospital quality measures on the
Hospital Compare Web site as soon as possible, after they have been
adopted and have been reported to CMS. However, if there are unresolved
display issues or pending design considerations, we may make the data
available on other, non-interactive, CMS Web sites such as http://www.cms.hhs.gov/HospitalQualityInits/. Publicly reporting the
information in this manner, though not on the interactive Hospital
Compare Web site, allows us to meet the requirement under section
1833(t)(17)(E) of the Act for establishing procedures to make quality
data submitted available to the public following a preview period. When
we display hospital quality information on non-interactive CMS Web
sites, affected parties will be notified via CMS
[[Page 68471]]
listservs, CMS email blasts, memoranda, Hospital Open Door Forums,
national provider calls, and QualityNet announcements regarding the
release of preview reports followed by the posting of data on a Web
site other than Hospital Compare.
We also require hospitals to complete and submit a registration
form (``participation form'') in order to participate in the Hospital
OQR Program. With submission of this participation form, participating
hospitals agree that they will allow CMS to publicly report the quality
measure data submitted under the Hospital OQR Program, including
measures that we calculate using Medicare claims.
Comment: One commenter urged CMS to continue to use both
stakeholders and focus groups to develop and evaluate terminology to
present user-friendly measurement data on Hospital Compare. The
commenter believed this procedure would help to decrease misinformation
and unnecessary alarm to patients. Another commenter questioned the
value of the ``old'' data and the ``outdated time-frame of data
collection period'' presented in Hospital Compare, in facilitating
health care decisions by Medicare beneficiaries.
Response: On Hospital Compare, we strive to provide consumers with
meaningful information that they can use to help make healthcare
decisions. When warranted, we use formative consumer testing to assure
the language and display of information makes sense to consumers before
posting. Formative testing allows CMS to adjust displays and language
so that they are more meaningful to consumers based on consumer
feedback. At the same time, we believe that it is critical to maintain
the integrity of the measure intent, thereby not simplifying the data
too much as to risk making the information so general that it is not
meaningful.
The data we publicly report do not all have the same performance
period. For example, the process-of-care measures are collected
quarterly and are displayed as a rolling four quarters of data on
Hospital Compare. We allow 4 to 4.5 months after the reporting quarter
for hospitals to submit their complete data to the CMS clinical data
warehouse. In contrast, the outcomes measures are calculated using 3
years of data from Medicare fee for service claims.
Comment: One commenter was concerned that the display of the
acceptable quality range and benchmarks publicly reported for the
Outpatient Imaging Efficiency (OIE) measures may cause unnecessary
alarm to consumers.
Response: We appreciate the commenter's concerns. To provide
meaningful performance benchmarks, we will emphasize the ``within
range'' rates and facility outlier results in a facility's public
reporting so as to minimize the potential for negatively affecting
access to imaging services. In addition, we continue to use both
stakeholder and focus groups for developing and evaluating terminology
for presenting measurement data to the public, in order to avoid
misleading or alarming patients unnecessarily.
B. Process for Retention of Hospital OQR Program Measures Adopted in
Previous Payment Determinations
In past rulemakings, we have proposed to retain previously adopted
measures for each payment determination on a year-by-year basis and
invited public comments on the proposal to retain such measures for all
future payment determinations unless otherwise specified. In the CY
2013 OPPS/ASC proposed rule (77 FR 45178), for the purpose of
streamlining the rulemaking process, beginning with this rulemaking, we
proposed that when we adopt measures for the Hospital OQR Program
beginning with a payment determination and subsequent years, these
measures are automatically adopted for all subsequent year payment
determinations unless we propose to remove, suspend, or replace the
measures. We invited public comment on this proposal.
Comment: Some commenters recognized the importance of stability and
consistency in the Hospital OQR Program set and supported the proposed
automatic retention of Hospital OQR Program measures adopted in a
previous year for subsequent payment year determinations. One commenter
stated that proposed rulemakings should be devoted to address new
changes rather than repeating discussions of continuing measures
previously adopted. However, the commenter urged CMS to publish the
full list of measures to be continued, in the OPPS/ASC proposed rule
each year. The commenter believed publishing the list of measures would
provide the public the opportunity to comment and to share experience
on current measures.
Response: We appreciate the commenters' recognition of the
importance of our goal to streamline the administrative process in
rulemaking. As suggested by the commenters, we will continue to publish
the full list of measures to be continued in the OPPS proposed rules,
for the public to provide input and share experience.
Comment: A few commenters urged that CMS continue to propose all
Hospital OQR Program measures adopted, on an annual basis. Commenters
were concerned that if measure retention occurs without going through
the rulemaking process year by year, irrelevant and obsolete measures
may not be removed timely, and the transparency of the rulemaking
process will be compromised.
Response: We do not believe the proposed measure retention policy
will compromise the transparency in rulemaking or slow down the removal
or suspension of problematic measures. Rather, the measure retention
policy would enhance administrative efficiency while providing clear
expectations to hospital providers. Should we decide there is a need to
remove or suspend a measure for concerns of patient safety, we will act
expeditiously to remove or suspend the measure between rulemaking
cycles. We will notify the public by using memoranda, email blasts
distributed through QualityNet, and news postings on the ``Splash
page'' on QualityNet. We will thereafter confirm the removal or
suspension of the measure through rulemaking.
In the FY 2010 IPPS/LTCH PPS rulemaking, we adopted a process for
the Hospital IQR Program for immediate measure removal based on
evidence that the continued use of the measure as specified raises
patient safety concerns. In the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60634), we adopted this same policy to be used in
the Hospital OQR Program. Furthermore, should we determine that a
measure is problematic based upon other criteria stated in the CY 2013
OPPS/ASC proposed rule (77 FR 45178), we will utilize rulemaking to
propose the removal or suspension of the measure and obtain public
comment prior to determining whether to remove or suspend the measure.
After consideration of the public comments we received, we are
finalizing the automatic retention of Hospital OQR Program measures
adopted in previous payment determinations for subsequent year payment
determinations.
[[Page 68472]]
C. Removal or Suspension of Quality Measures From the Hospital OQR
Program Measure Set
1. Considerations in Removing Quality Measures From the Hospital OQR
Program
In the FY 2010 IPPS/LTCH PPS rulemaking, we finalized a process for
immediate retirement of Hospital IQR Program measures based on evidence
that the continued use of the measure as specified raises patient
safety concerns (74 FR 43864 through 43865). We adopted this same
immediate measure retirement policy for the Hospital OQR Program in the
CY 2010 OPPS/ASC final rule with comment period (74 FR 60634).
In previous Hospital IQR Program rulemakings, we have referred to
the removal of measures from the Hospital IQR Program as
``retirement.'' We have used this term to indicate that Hospital IQR
Program measures are no longer included in the Hospital IQR Program
measure set for one or more indicated reasons. However, we note that
this term may imply that other payers/purchasers/programs should cease
using these measures that are no longer required for the Hospital IQR
Program. In order to clarify that this is not our intent, we stated in
the FY 2013 IPPS/LTCH PPS proposed rule (77 FR 28034) that we will use
the term ``remove'' rather than ``retire'' to refer to the action of no
longer including a measure in the Hospital IQR Program. In the CY 2013
OPPS/ASC proposed rule (77 FR 45178), we proposed to adopt the same
terminology of ``removal'' in the Hospital OQR Program to indicate our
action of discontinuing a measure in the Hospital OQR Program.
In the FY 2011 IPPS/LTCH PPS final rule (75 FR 50185), we finalized
a set of criteria to use when determining whether to remove Hospital
OQR Program measures. These criteria are: (1) Measure performance among
hospitals is so high and unvarying that meaningful distinctions and
improvements in performance can no longer be made (``topped out''
measures); (2) performance or improvement on a measure does not result
in better patient outcomes; (3) a measure does not align with current
clinical guidelines or practice; (4) the availability of a more broadly
applicable (across settings, populations, or conditions) measure for
the topic; (5) the availability of a measure that is more proximal in
time to desired patient outcomes for the particular topic; (6) the
availability of a measure that is more strongly associated with desired
patient outcomes for the particular topic; and (7) collection or public
reporting of a measure leads to negative unintended consequences such
as patient harm. These criteria were suggested by commenters during
Hospital IQR Program rulemaking, and we determined that these criteria
are also applicable in evaluating Hospital OQR Program quality measures
for removal. In the CY 2013 OPPS/ASC proposed rule (77 FR 45178), we
proposed to apply these measure removal criteria in the Hospital OQR
Program as well, and we invited public comments on these proposals.
In addition to these criteria, we take into account the views of
the Measure Application Partnership (MAP) in the evaluation of measure
removal. The MAP is a public-private partnership convened by the NQF
for the primary purpose of providing input to HHS on selecting
performance measures for certain quality reporting programs and pay for
performance programs. The MAP views patient safety as a high priority
area and it strongly supports the use of NQF-endorsed measures.
Furthermore, for efficiency and streamlining purposes, we strive to
eliminate redundancy of similar measures.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45178), we did not
propose to retire any measures from the Hospital OQR Program.
Comment: A few commenters agreed with CMS that the term ``removal''
is preferable to ``retirement'' as the measure at issue may still be
relevant in other payers/purchasers/programs. The commenters supported
all of the proposed measure removal criteria. One commenter noted that
CMS should not always choose the availability of measures applicable to
a broader patient population as a measure removal criterion, over
focused measures targeted at subsets of patient population. The
commenter asserted that in some instances, condition-specific measures
are warranted.
Response: We thank the commenters for the support of the measure
removal criteria. We are cognizant that some focused measures targeted
at subsets of patient population are also relevant in the Hospital OQR
Program. We want to clarify that before considering the removal of a
measure in any given situation, we first assess whether the removal
criteria are relevant. We would not be likely to propose the removal of
a measure because there is a measure with broader applicability if what
we seek to measure requires a more targeted, condition or patient-
specific assessment. We might, on the other hand, consider removal of a
measure based on the availability of a measure that is more strongly
associated with desired patient outcomes for a particular topic, since
this might result in a focused measure that is targeted to subsets of
patient populations. In any given situation, we will focus only on
removal criteria that are relevant to a particular set of
circumstances. If more than one of the measure removal criteria appears
to be relevant, we intend to take a balanced approach in assessing the
value of each of the different criteria in a given situation before
removing any measure.
Comment: One commenter requested that besides using CMS program
data, CMS should also solicit input from developers and analyze data
from EHRs and registries to identify topped-out measures. To avoid the
unintended consequence of hospitals not spending resources on specific
interventions due to measure removal, one commenter urged CMS to
suspend the measures at issue rather than removing measures whenever
feasible. In addition, the commenter requested that CMS solicit public
input before suspending or removing a measure.
Response: We expect hospitals to always follow appropriate standard
of care and clinical guidelines in exercising positive interventions,
regardless of whether a measure is being suspended or removed. Should
we propose to remove measures using the rulemaking process, we seek
input from the public, including measure developers and entities using
EHRs to collect the measures. However, in the case of suspension or
removal due to patient safety concerns, action would need to be taken
quickly and may not coincide with rulemaking cycles. Should this occur,
we would seek to suspend measures in situations where we believe the
measure can be re-specified in a manner that would not be overly
prescriptive or overly burdensome to providers.
Comment: A few commenters urged CMS to closely align its measure
removal with the MAP recommendations. The commenters cited as examples
of measures that should be removed 7previously adopted Hospital OQR
Program measures that are not NQF-endorsed and not recommended by the
MAP.
Response: As we have already stated, we consider all of the MAP
input we receive, including its recommendations for removal of
measures, before making a decision about removing or keeping any
particular measure. We did not include any proposals regarding the 7
measures that the commenters mentioned in the CY 2013 OPPS/ASC
[[Page 68473]]
proposed rule. As such, we are not making any revisions to these
measures in this rulemaking. However, we thank the commenters for these
measure removal suggestions and will take them into consideration for
future measure removal.
We note that section 1833(t)(17)(C)(i) of the Act requires the
Secretary to develop measures that the Secretary determines to be
appropriate for the measurement of the quality of care furnished by
hospitals in outpatient settings and that reflect consensus among
affected parties and, to the extent feasible and practicable to include
measures set forth by one or more national consensus building entities.
The Act does not require that the measures we adopt for the Hospital
OQR Program be endorsed by any particular entity, such as the NQF. In
addition, we believe that consensus among affected parties can be
reflected by means other than endorsement by a national consensus
building entity, including consensus achieved during the measure
development process, consensus shown through broad acceptance and use
of measures, and consensus through public comment. Finally, the Act
does not require us to do more than consider MAP input.
Comment: One commenter inquired about the criteria for resuming
data collection for measures that are removed or temporarily suspended
from the Hospital OQR Program.
Response: Measures that are removed must be proposed through
rulemaking in order to be added back to the program prior to collecting
data. For suspended measures, we will strive to align with the regular
quarterly collection cycle that has been established for chart-
abstracted measures, and we will provide sufficient notice (at least 3
months) prior to resuming collection of suspended measures. We will
notify hospitals of resumed collection the same way we notify them of
suspension--through QualityNet memoranda and email blasts. We also
intend to issue addenda to Specifications Manual releases. However,
should we determine that the re-specified measure is substantively
changed; that is, changes have been made that affect the underlying
quality concepts being measured, we would use rulemaking to formally
propose to replace the suspended measure with the modified measure. As
we have noted in an earlier response, examples of changes that we might
generally consider to be substantive would be those in which the
changes are so significant that the measure is no longer the same
measure, or when a standard of performance assessed by a measure
becomes more stringent.
After consideration of the public comments we received, we are
finalizing the term ``removal'' to indicate future action of
discontinuing a measure in the Hospital OQR Program. Also, we are
finalizing the adoption of the measure removal criteria used in the
Hospital IQR Program for the Hospital OQR Program. We also thank the
commenters for the suggestions to keep, remove, or change the status of
some of the measures we previously adopted. At this time, we intend to
keep the measures as adopted.
2. Removal of One Chart-Abstracted Measure for the CY 2013 and
Subsequent Years Payment Determinations
In the FY 2010 IPPS/LTCH PPS final rule (74 FR 43863), we
established a precedent to immediately remove a measure from a measure
set using a subregulatory notification process followed by subsequent
confirmation in rulemaking in situations when there is a reason to
believe that continued collection of the measure raises patient safety
concerns, and the measure cannot be reasonably revised in a manner that
would alleviate the concern without being overly complex. For CY 2013
and subsequent year payment determinations, we are confirming what we
stated in our August 13, 2012, memorandum ``Removal of Hospital
Outpatient Quality Reporting Measure (OQR) OP-16: Troponin results for
Emergency Department acute myocardial infarction (AMI) patients or
chest pain patients (with Probable Cardiac Chest Pain) Received Within
60 minutes of arrival'' that we have removed measure OP-16. (To review
this memorandum, visit http://www.qualitynet.org; from this page,
choose ``Hospitals-Outpatient'' from the drop down menus across the top
of the page, then click on ``Email-Notifications.'' Memoranda are
listed by date of publication.)
We adopted measure OP-16 for the Hospital OQR Program for the CY
2013 payment determination with data collection beginning with January
1, 2012 encounters. However, we are removing OP-16 from the Hospital
OQR measure set based on patient safety concerns. On July 11, 2012 the
Food and Drug Administration (FDA) issued a Class I recall on several
point of care (POC) testing kits, including those that provide Troponin
results. The Class I recall was due to an increased frequency of false
positive and false negative results. FDA defines a Class I recall as:
``a situation in which there is a reasonable probability that the use
of or exposure to a violative product will cause serious adverse health
consequences or death.'' The FDA safety alert appears at the following
Web site: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311405.htm.
While OP-16 did not specify which type of laboratory equipment
should be used to obtain Troponin results, hospitals may be using these
POC tests in order to expedite results. We understand that the FDA
considers the size of this recent Class I recall to be large. Due to
the magnitude of this recall, we became concerned that continued
collection of the measure may potentially impact patient safety because
of the high probability of false results associated with the equipment.
We chose to remove the measure from the program rather than suspend the
measure because revision of the measure to address this issue would
result in an overly prescriptive and complex measure. On August 13,
2012, we released a memorandum ``Removal of Hospital Outpatient Quality
Reporting Measure (OQR) OP-16: Troponin results for Emergency
Department acute myocardial infarction (AMI) patients or chest pain
patients (with Probable Cardiac Chest Pain) Received Within 60 minutes
of arrival.'' This memorandum notified the Hospital OQR Program
stakeholder community to cease chart abstraction for the OP-16 measure
immediately, and that CMS will not publically report, validate or use
in the CY 2013 payment determination any data collected on this
measure. The memorandum dated August 13, 2012 is available for review
at the QualityNet Web site. To review this memorandum, access http://
www.qualitynet.org; from this page, choose ``Hospitals-Outpatient''
from the drop down menus across the top of the page, then click on
``Email-Notifications.'' Memoranda are listed by date of publication.)
Since the memorandum was issued, we have received two Congressional
inquiries from POC device manufacturers indicating that our decision to
remove the measure will impact them negatively. One commenter also
indicated that the measure has encouraged increased communication in
the Emergency Department and expressed concern that removal of the
measure would result in reduced communication.
We emphasize that despite the removal of OP-16 from the Hospital
OQR Program, we expect hospitals to continue the timely triage,
diagnosis
[[Page 68474]]
and treatment of cardiac and other patients in the ED according to
established clinical guidelines. We also expect that hospitals will
continue their efforts to improve communication and throughput in the
ED.
Although we have requested immediate discontinuation of chart
abstraction for OP-16, CMS is unable to cease data collection in the
system until January 1, 2013, when we have made certain system changes.
In order to overcome CMS's system limitation, hospitals can choose to
submit a meaningless value for this measure through December 31, 2012.
We ask hospitals not to submit a blank value for OP-16, as a lack of a
populated value for OP-16 will cause a case to be rejected. If a case
is rejected due to lack of data, this could impact a hospital's ability
to meet the Hospital OQR requirements. Some vendors may have the
capability to provide a default value for OP-16. Hospitals are
encouraged to work with their vendors to determine options to populate
the OP-16 data field at submission.
Comment: A few commenters supported the removal of OP-16 and
believed that there was insufficient evidence to link this process
measure to patient outcomes. However, some commenters were concerned
that the removal of OP-16 may undermine the importance of Troponin
testing or the need to receive the results of Troponin testing in a
timely manner. Commenters asserted that clinical guidelines for the
diagnostic evaluation of patients with AMI or presumed cardiac chest
pain still recommend receiving results from cardiac marker testing,
including Troponin, within 60 minutes. The commenters urged that CMS
either reconsider the removal of OP-16 or provide guidance on when the
measure will be reinstated. Commenters added that currently, there are
new and improved Troponin testing technologies available that would
meet the intent of OP-16.
Response: We thank the commenter for the support of the removal of
this measure. We also clarify that hospitals should not cease testing
Troponin and other cardiac markers, nor should they cease following
clinical guidelines for diagnosis and treatment of cardiac patients
based on our decision to remove OP-16 from the Hospital OQR Program. We
are considering initiating a call for measures for this program, and
will consider suggestions for measures on this and other topics that
are submitted through such a process for future rulemaking.
Comment: A few commenters perceived the CMS' instruction to submit
a blank value for OP-16 to be burdensome and stated that hospitals or
their vendors should not have to bear the responsibility of submitting
meaningless data. Commenters urged CMS to work with contractors to
derive a technical solution that would not require hospitals to submit
meaningless data.
Response: As we stated in our memorandum, we urge hospitals to work
with their data submission vendors on low-burden ways to populate
fields for measures that are suspended or removed until such time as
our system changes can be made. In the case of OP-16, this will be
January 1, 2013. We have asked our systems developers to add
functionality to remove a measure from the data collection system
without any delay and this feature will be incorporated into a future
release of our hospital reporting data collection system. In addition,
we have added a business requirement for our contractor to fix this as
soon as possible and it has been prioritized as high as possible given
all the competing demands on contract programmers.
We are confirming the removal of measure OP-16: Troponin Results
for Emergency Department Acute Myocardial Infarction (AMI) Patients or
Chest Pain Patients (with probable cardiac chest pain) Received Within
60 Minutes of Arrival from the Hospital OQR Program in this final rule
with comment period.
3. Suspension of One Chart-Abstracted Measure for the CY 2014 and
Subsequent Years Payment Determinations
In April of this year, we took immediate action to suspend OP-19
because of patient safety concerns. We chose to suspend this measure
rather than to immediately remove the measure from the program because
the probability of harm occurring was relatively low, any potential
harm that occurred would not be the direct result of patient care
rendered at facilities, and the measure steward believed that the
measure could be quickly re-specified in a manner that would mitigate
the concerns raised by hospitals and stakeholders.
For CY 2014 and subsequent year payment determinations, we are
confirming that we have suspended the collection of measure OP-19:
Transition Record with Specified Elements Received by Discharged ED
Patients, which specifies patients or their caregivers (emphasis added)
receive a transition record at the time of ED discharge. We adopted
measure OP-19 for the Hospital OQR Program for the CY 2013 payment
determination with data collection beginning with January 1, 2012
encounters. Since data collection for this measure began, concerns have
been raised about the current measure specifications, including
potential privacy concerns related to releasing certain elements of the
transition record to a patient who is being discharged from an
emergency department or the patient's caregiver. Some examples provided
by hospitals of this were the release of sensitive lab results or
radiological findings to a parent, spouse, or guardian of a minor
patient, or to the responsible party for a physically incapacitated
patient.
In regard to the issue of patient safety, there is evidence that,
in some cases, following the measure as currently specified could lead
to patient harm especially when the medical results relate to
pregnancy. During field testing of this measure, some women refused to
accept transition records that documented pregnancy results. While it
is unclear what motivated these particular women to decline to receive
transition records, literature supports a rationale for why pregnant
women may be reluctant to receive documentation of pregnancy results;
under certain circumstances, pregnancy is associated with increased
risk of physical violence from a current or former male partner
(Richardson, J. et al., 2002. Identifying domestic violence: cross
sectional study in primary care, British Medical Journal).
After consideration of these issues and internal review of the
measure specifications, we decided to suspend data collection for OP-19
effective with January 1, 2012 encounters until further notice. On
April 2, 2012 we released a memorandum ``Temporary Suspension of
Hospital Outpatient Quality Reporting Measure OP-19: Transition Record
with Specified Elements Received by Discharged Patients.'' This
memorandum notified the Hospital OQR Program stakeholder community that
we had suspended data collection for the OP-19 measure effective with
January 1, 2012 encounters and until further notice.
On April 12, 2012, we released a memorandum, ``Revised: Temporary
Suspension of Hospital Outpatient Quality Reporting Measure OP-19:
Transition Record with Specified Elements Received by Discharged
Patients'' to make clear our intent not to use any data submitted on
this measure for payment determinations, public reporting, or in
validation. The revised SDPS Memo is available for review at the
QualityNet Web site (http://www.qualitynet.org) under the option
[[Page 68475]]
``Email Notifications'' within the ``Hospitals--Outpatient'' drop down
menu found at the top of the page.
When NQF completes its maintenance review on this measure, and we
have incorporated the necessary changes to the measure specifications
in our measure manual, we anticipate being able to resume data
collection, and will notify hospitals of changes in the suspension
status of the measure for Hospital OQR via email blast.
Because CMS system constraints prevent immediate cessation of data
collection, hospitals must continue to submit information for this
measure during this temporary suspension. The data collection system
currently requires a populated value for OP-19. During the period of
time that the measure is suspended, hospitals may choose to populate
their OP-19 submission field with a value that is not meaningful.
Hospitals should not submit a null value because the lack of data for
OP-19 will cause the submitted case to be rejected entirely from the
data warehouse. In other words, failure to populate the OP-19 field
could compromise reporting data for other measures for that same case
because more than one measure can be reported within a single case.
Some vendors may have the capability to provide a default value for
this measure to reduce data abstraction. Hospitals are encouraged to
work with their vendors to determine options to reduce abstraction
burden.
If a case is rejected from the data warehouse on the basis of a
system error due to the current system's inability to accept a case
without OP-19 data populated, in the event that the rejected case would
have also fulfilled reporting requirements for one or more other
measures, this rejection would could affect a hospital's ability to
meet Hospital OQR Program requirements.
Therefore, we recommend continuing to submit a value for OP-19,
although we will not use data submitted on OP-19 for payment
determinations, will not publicly report these data, and will not
validate these data until all concerns are resolved and measure
specifications are refined as necessary.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45178), because the
developer is working to revise the measure specifications to address
the concerns raised by affected parties, and the measure is undergoing
NQF maintenance review this year, we did not propose to remove the
measure from the program at this time. After completion of the NQF
maintenance process, we anticipate that normal program operations for
this measure could resume once we have updated the Hospital OQR
Specifications Manual and made any necessary changes to our data
collection infrastructure. However, should we determine that these
concerns cannot be addressed, we would propose to remove this measure
in a future OPPS/ASC rule. We invited public comment on the suspension
of OP-19 until further notice. We also invited public comment on
whether the measure should be removed from the program at this time.
Comment: A few commenters strongly urged CMS to retain the OP-19
measure, with the ongoing revision of the measure specifications to
address privacy concerns.
Some commenters advocated the removal of this measure on grounds
that are completely different from CMS's rationale for removing this
measure. Some commenters were concerned that many patients may not be
able to comprehend most of the data elements (for example, lab tests
and results, and procedures performed in the ED) required by the
measure, which would be in the transition record. Many commenters
believed that the provision of transition records by EDs would not
enhance coordination between sites of care. Rather, the commenters
stated it will increase the likelihood of confusion for the patients.
Commenters were concerned that: (1) the transition records including
instructions issued upon ED discharge are not final and may be changed
subsequently by the observation unit staff, should the patient be put
in the observation unit; and (2) the ED transition records may conflict
with the subsequent transition record provided by the receiving
provider, such as the home health care agency. In the commenters' view,
the Emergency Medical Treatment and Labor Act (EMTALA) regulation
already provides for the transfer of records that include communication
between nurses and physicians. Some commenters suggested the provision
of a simplified, user-friendly ED visit summary to patients would be a
better alternative.
A few commenters requested clarification of the data elements
specified in the Specifications Manual: major procedures and tests;
patient instructions; follow up care; ED patient population; and
medication types. Commenters stated that the data elements specified in
the Specifications Manual are too vague and leave room for different
interpretation. One commenter recommended creating individual measures
to address each of the items that need to be included in the ED visit
summary.
One commenter requested limiting the transition record information
to include only diagnostic test procedures performed in the ED. One
commenter did not view patients put on observation as ED patients and
requested they be treated as exclusions in the measure specification.
These commenters did not discuss their reasons for requesting these
changes.
One commenter stated that currently, since hospitals are at
different stages of implementing electronic health records technology,
the time taken to generate electronic transition records will vary
greatly. For some hospitals, this may potentially delay the discharge
of patients from the ED.
Response: We appreciate the support and the recommendations from
the commenters. As for the comments on clarification of data elements
in the Specifications Manual, we note that there are no specific
requirements related to what constitutes appropriate documentation that
must be transferred to the next site of care.
We are aware of the concerns expressed by the commenters. Since the
suspension of OP-19 on April 2, 2012, we have been actively working
with the American Medical Association Physician Consortium for
Performance Improvement (AMA-PCPI) (the measure stewards) to clarify
the specifications of this measure. The intent of OP-19 is to require a
transition record to patients discharged directly to home or home
health, not those patients who would otherwise be transferred to an
acute care facility, regardless of EMTALA status. It is our hope that
the revised specifications will address the commenters' concerns prior
to reinstatement of the measure in the Hospital OQR Program.
Comment: Many commenters perceived the submission of a blank value
for OP-19, as requested by CMS, to be burdensome and stated that
hospitals or their vendors should not have to bear the responsibility
of submitting meaningless data. Commenters requested that CMS refine
specifications so that hospitals do not have to submit meaningless
data.
Response: As we stated in our April 12, 2012 revised memorandum, we
urge hospitals to work with their data submission vendors on low-burden
ways to populate fields for measures that are suspended or removed
until such time as our system changes can be made.
We are confirming the suspension until further notice of measure
OP-19: Transition Record with Specified Elements Received by Discharged
ED Patients, effective with January 1, 2012
[[Page 68476]]
encounters. We are working with the measure steward, the AMA, to
enhance OP-19 for future use. When the measure specifications have been
updated and reviewed by the NQF, we will consider implementation of the
revised measure.
4. Deferred Data Collection of OP-24: Cardiac Rehabilitation Measure:
Patient Referral From an Outpatient Setting for the CY 2014 Payment
Determination
In the CY 2012 OPPS/ASC final rule with comment period, we
finalized OP-24: Cardiac Rehabilitation Measure: Patient Referral From
an Outpatient Setting for the CY 2014 payment determination and
indicated that the applicable quarters for data collection for this
measure would be 1st quarter CY 2013 and 2nd quarter CY 2013 (76 FR
74464, 74481). In order for us to adhere to this data collection
schedule, we would have needed to have published the measure
specifications in the July 2012 release of the Hospital OQR
Specifications Manual. While there are NQF-endorsed specifications for
this measure, in order to implement standardized data collection on a
national scale, we must include detailed abstraction instructions for
chart-based measures in our Specifications Manual. These instructions
were not completed and tested in time to include in the July 2012
release of the Specifications Manual, which includes collection
instructions for measures beginning January 1, 2013. This was an
unanticipated delay in implementation that we do not expect to be a
regularly occurring issue for the Hospital OQR Program.
Therefore, in the CY 2013 OPPS/ASC proposed rule (77 FR 45179), we
proposed to defer the data collection for this measure to January 1,
2014 encounters. We also proposed that the measure would no longer be
used for the CY 2014 payment determination, and that its first
application would be for the CY 2015 payment determination. The data
collection deferral for this measure is detailed in the ``Form, Manner,
and Timing'' section of this final rule with comment period. We invited
public comments on these proposals.
Comment: Many commenters supported the proposed deferred data
collection of this measure until detailed instructions for data
collection are completed. Commenters believed the measure is beneficial
for patients with cardiovascular diseases and they were hopeful that
the measure could be included into the Hospital OQR program for
implementation beginning with January 1, 2014 encounters.
Response: With the inclusion of the abstraction instructions for
this chart-abstracted measure in our July 2013 release of the
Specifications Manual, we anticipate that data collection can begin
with January 1, 2014 encounters.
Comment: One commenter asked if the data for this measure could be
collected through claims instead of chart-abstraction. Also, the
commenter viewed this measure as merely documentation of a referral
being offered as the patient could have refused the referral to enroll
in a cardiac rehabilitation program.
Response: This measure cannot be collected via claims because
patient referral is not captured in claims data. We recognize that this
measure does not focus on whether the patient actually enrolls in a
cardiac rehabilitation program. Rather, the measure focuses on the
process of referring a patient to a cardiac rehabilitation or secondary
prevention program.
Comment: One commenter requested clarification on: (1) What setting
will be included in the denominator for the measure population; (2)
definition of an outpatient practice; and (3) definition of an
outpatient clinic practice. The commenter interpreted the measure
specification developed by the American Association of Cardiovascular
and Pulmonary Rehabilitation, American College of Cardiology
Foundation, and the American Heart Association (AACVPR/AACF/AHA) Task
Force to mean that the measure is intended for physicians providing
follow-up care to patients after an acute event, and not for hospital
outpatient department care. The commenter, therefore, suggested the
removal of the current OP-24 measure and adoption of the measure
``Cardiac Rehabilitation Patient Referral from an Inpatient Setting''
for the Hospital OQR Program.
Response: We intend to operationalize the measure for patients seen
for ongoing care at outpatient clinics affiliated with hospitals. The
measure is designed for the outpatient setting and the denominator is
intended to be the percentage of patients who had a qualifying event/
diagnosis during the previous 12 months and have not participated in an
outpatient cardiac rehabilitation program. Given the measure focus on
the process of referring a hospital outpatient clinic patient to a
cardiac rehabilitation program, we expect it will incentivize Hospital
Outpatient Departments (HOPDs) to better coordinate the care that their
patients receive. We agree that the measure could also be appropriate
as a measurement for physicians' follow-up care. We are currently
working on the definitions the commenter has requested, outpatient
practices and outpatient clinic practices, in the context of the HOPD.
After consideration of the public comments we received, we are
finalizing the deferred data collection for OP-24 from January 1, 2013
to January 1, 2014 encounters for the CY 2015 payment determination.
D. Quality Measures for the CY 2015 Payment Determination
We previously finalized 26 measures for the CY 2015 Hospital OQR
Program measure set in the 2012 OPPS/ASC rulemaking (76 FR 74472
through 74474).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45179), taking into
consideration the time and effort for CMS to develop, align, and
implement the infrastructure necessary to collect data on the Hospital
OQR Program measures and make payment determinations, as well as the
time and effort on the part of hospital outpatient departments to plan
and prepare for reporting additional measures, we did not propose any
additional quality measures for CY 2015 and subsequent years payment
determinations in this rulemaking.
As discussed above, we have removed OP-16 as of August 2012, we
suspended measure OP-19 and deferred data collection for OP-24 until
the measure specifications can be further refined.
In summary, in this final rule with comment period, we are not
adopting additional measures for the CY 2015 payment determination, and
we are retaining 25 of the 26 measures previously adopted for the CY
2014 payment determination for CY 2015 and subsequent year payment
determinations.
Set out below are the previously adopted measures which we are
retaining for the CY 2014, CY 2015, and subsequent years payment
determinations under the Hospital OQR Program.
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Comment: Many commenters commended CMS' pausing in the expansion of
the Hospital OQR Program by not proposing any new measures for the CY
2014 and CY 2015 payment determinations. Commenters appreciated CMS'
recognition of burden from quality reporting on providers.
Response: We thank the commenters for supporting our decision not
to add any new measures. We plan to continue to find ways to strike a
balance between quality reporting and burden reduction for providers.
We received comments on some of the previously finalized measures
that we have proposed to continue using under the Hospital OQR Program.
Comment: Commenters expressed support and opposition to the adopted
measures from previous rulemakings. Commenters also provided
suggestions on these measures, regarding measure implementation, adding
exceptions, and revising measure specifications.
Response: We thank the commenters for their comments; those
supporting our previously finalized proposals as well as those in
opposition. We will consider all of these views for future rulemaking
and Hospital OQR Program development.
E. Possible Quality Measures Under Consideration for Future Inclusion
in the Hospital OQR Program
The current measure set for the Hospital OQR Program includes
measures that assess process of care, imaging efficiency patterns, care
transitions, ED throughput efficiency, the use of HIT care
coordination, patient safety, and volume. We anticipate that as EHR
technology evolves and more infrastructure is put into place, we will
have the capacity to accept electronic reporting of many clinical
chart-abstracted measures that are currently part of the Hospital OQR
Program using certified EHR technology. We work diligently toward this
goal. We believe that this future progress at a future date, such as FY
2015, would significantly reduce the administrative burden on hospitals
under the Hospital OQR Program to report chart-abstracted measures. We
recognize that considerable work needs to be done by measure owners and
developers to make this possible with respect to the clinical quality
measures targeted for e-specifications. This includes completing
electronic specifications for measures, pilot testing, reliability and
validity testing, and implementing such specifications into certified
EHR technology to capture and calculate the results, and implementing
the systems.
We seek to develop a comprehensive set of quality measures to be
available for widespread use for informed decision-making and quality
improvement in the hospital outpatient setting. Therefore, through
future rulemaking, we intend to propose new measures that help us
further our goal of achieving better health care and improved health
for Medicare beneficiaries who receive health care in hospital
outpatient settings. In addition, we are considering initiating a call
for input to assess the following measure domains: clinical quality of
care; care coordination; patient safety; patient and caregiver
experience of care; population/community health; and efficiency. We
believe this approach will promote better care while bringing the
Hospital OQR Program in line with other established quality reporting
and pay for performance programs such as the Hospital IQR Program.
We invited public comment on this approach and on our suggestions
and rationale for possible quality measures for future inclusion in the
Hospital OQR Program.
Comment: One commenter noted that it is important to address the
priority areas in the National Quality Strategy; however, the commenter
also suggested that measure selection should not be limited to only
those that fall inside the six domains, as this would hinder
improvement in other areas in HOPDs.
Response: We note that the six domains of measurement that arise
from the six priorities of the National Quality Strategy are some of
our considerations in measure selection. We also weigh other aspects of
measures as delineated in our measure selection criteria.
Comment: A few commenters strongly supported CMS in considering
whether to initiate a call to get input to assess the measure domains.
One commenter requested that CMS use the same process used in past
rulemakings by providing a list of measures under consideration for
future years for public input.
Response: In the past, we have solicited comments on a list of
measures in the rule that are under consideration for future years of
the program. Although we did not provide a list in this year's
rulemaking, we will take this comment under consideration in future
years.
In addition, we will consider hosting a call for measures for the
Hospital OQR Program in the future.
Comment: Commenters suggested that CMS add the following measures
to the Hospital OQR Program: a comprehensive ``medication
[[Page 68479]]
management'' measure set; a system of care metric that looks at the
overall median time to PCI in transferred patients to capture the
entire process of care; a stroke measure set for outpatients; measures
for diabetes care, congestive heart failure, heart attack, breast
cancer detection rate, central-line associated blood stream infection,
chronic obstructive pulmonary disease, coronary artery disease, and
depression screening.
Response: We thank the commenters for the input on future measures
and will take them into consideration in future measure selections.
Comment: One commenter strongly encouraged CMS to adopt registry-
based measures for which providers submit quality data directly to a
registry instead of to CMS.
Response: We thank the commenter for the recommendation for
registry reporting. We intend to continue considering how registry
reporting may be leveraged as a reporting mechanism for this and other
quality programs.
Comment: A few commenters recommended that for burden reduction,
CMS should harmonize measures in the Medicare and Medicaid EHR
Incentive Programs and the Hospital OQR Program as well as limiting
adopting future measures to e-specified measures only.
Response: As we stated previously, coordinated efforts to align
measures in the Medicare and Medicaid public reporting programs and
incentive payment systems have been ongoing, and we are working toward
the eventual adoption of electronically-specified measures so that data
can be calculated and submitted via certified EHR technology with
minimal burden.
Comment: One commenter recommended that CMS refrain from adopting
claims-based measures which the commenter believed are purely
administrative in nature and yield little value in measuring quality of
care.
Response: While we recognize the merits of chart-abstracted
measures, we also believe that claims may still be needed to identify
prior events and diagnosis for measures that require look-back periods,
involving the matching of data for a single patient over a long period
of time (for example, 1 year of prior history) across multiple
settings. Claims-based measurement facilitates the use of historical
and longitudinal information on Medicare beneficiaries across
providers.
Comment: Commenters also expressed views and provided suggestions
regarding additional topics and previously finalized proposals
including:
Topped-out measures;
ED measures;
Outpatient imaging efficiency measures; and
Removal of additional adopted measures.
Response: We appreciate the commenters' views on these additional
topics or our previously finalized measures. However, these additional
topics were not the subject of our proposed rule. It is our policy to
retain previously adopted measures unless we specifically propose to
remove or suspend measures, or take action outside of rulemaking to do
so for patient safety reasons. We will consider these suggestions in
future Hospital OQR Program development.
F. Payment Reduction for Hospitals That Fail To Meet the Hospital OQR
Program Requirements for the CY 2013 Payment Update
1. Background
Section 1833(t)(17) of the Act, which applies to subsection (d)
hospitals (as defined under section 1886(d)(1)(B) of the Act), states
that hospitals that fail to report data required to be submitted on the
measures selected by the Secretary, in the form and manner, and at a
time, required by the Secretary will incur a 2.0 percentage point
reduction to their Outpatient Department (OPD) fee schedule increase
factor, that is, the annual payment update factor. Section
1833(t)(17)(A)(ii) of the Act specifies that any reduction applies only
to the payment year involved and will not be taken into account in
computing the applicable OPD fee schedule increase factor for a
subsequent payment year.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68769
through 68772), we discussed how the payment reduction for failure to
meet the administrative, data collection, and data submission
requirements of the Hospital OQR Program affected the CY 2009 payment
update applicable to OPPS payments for HOPD services furnished by the
hospitals defined under section 1886(d)(1)(B) of the Act to which the
program applies. The application of a reduced OPD fee schedule increase
factor results in reduced national unadjusted payment rates that apply
to certain outpatient items and services provided by hospitals that are
required to report outpatient quality data and that fail to meet the
Hospital OQR Program requirements. All other hospitals paid under the
OPPS that meet the reporting requirement receive the full OPPS payment
update without the reduction.
The national unadjusted payment rates for many services paid under
the OPPS equal the product of the OPPS conversion factor and the scaled
relative weight for the APC to which the service is assigned. The OPPS
conversion factor, which is updated annually by the OPD fee schedule
increase factor, is used to calculate the OPPS payment rate for
services with the following status indicators (listed in Addendum B to
this final rule with comment period, which is available via the
Internet on the CMS Web site): ``P,'' ``Q1,'' ``Q2,'' ``Q3,'' ``R,''
``S,'' ``T,'' ``V,'' ``U,'' or ``X.'' In the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68770), we adopted a policy that
payment for all services assigned these status indicators would be
subject to the reduction of the national unadjusted payment rates for
applicable hospitals, with the exception of services assigned to New
Technology APCs with assigned status indicator ``S'' or ``T,'' and
brachytherapy sources with assigned status indicator ``U,'' which were
paid at charges adjusted to cost in CY 2009. We excluded services
assigned to New Technology APCs from the list of services subject to
the reduced national unadjusted payment rates because the OPD fee
schedule increase factor is not used to update the payment rates for
these APCs.
In addition, section 1833(t)(16)(C) of the Act, as amended by
section 142 of the Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA) (Pub. L. 110-275), specifically required that
brachytherapy sources be paid during CY 2009 on the basis of charges
adjusted to cost, rather than under the standard OPPS methodology.
Therefore, the reduced conversion factor also was not applicable to CY
2009 payment for brachytherapy sources because payment would not be
based on the OPPS conversion factor and, consequently, the payment
rates for these services were not updated by the OPD fee schedule
increase factor. However, in accordance with section 1833(t)(16)(C) of
the Act, as amended by section 142 of the MIPPA, payment for
brachytherapy sources at charges adjusted to cost expired on January 1,
2010. Therefore, in the CY 2010 OPPS/ASC final rule with comment period
(74 FR 60641), we finalized our CY 2010 proposal, without modification,
to apply the reduction to payment for brachytherapy sources to
hospitals that fail to meet the quality data reporting requirements of
the Hospital OQR Program for brachytherapy services furnished on and
after January 1, 2010.
The OPD fee schedule increase factor is an input into the OPPS
conversion factor, which is used to calculate OPPS
[[Page 68480]]
payment rates. To implement the requirement to reduce the OPD fee
schedule increase factor for hospitals that fail to meet reporting
requirements, we calculate two conversion factors: A full market basket
conversion factor (that is, the full conversion factor), and a reduced
market basket conversion factor (that is, the reduced conversion
factor). We then calculate a reduction ratio by dividing the reduced
conversion factor by the full conversion factor. We refer to this
reduction ratio as the ``reporting ratio'' to indicate that it applies
to payment for hospitals that fail to meet their reporting
requirements. Applying this reporting ratio to the OPPS payment amounts
results in reduced national unadjusted payment rates that are
mathematically equivalent to the reduced national unadjusted payment
rates that would result if we multiplied the scaled OPPS relative
weights by the reduced conversion factor. To determine the reduced
national unadjusted payment rates that applied to hospitals that failed
to meet their quality reporting requirements for the CY 2010 OPPS, we
multiply the final full national unadjusted payment rate found in
Addendum B of the CY 2010 OPPS/ASC final rule with comment period by
the CY 2010 OPPS final reporting ratio of 0.980 (74 FR 60642).
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68771
through 68772), we established a policy that the Medicare beneficiary's
minimum unadjusted copayment and national unadjusted copayment for a
service to which a reduced national unadjusted payment rate applies
would each equal the product of the reporting ratio and the national
unadjusted copayment or the minimum unadjusted copayment, as
applicable, for the service. Under this policy, we apply the reporting
ratio to both the minimum unadjusted copayment and national unadjusted
copayment for those hospitals that receive the payment reduction for
failure to meet the Hospital OQR Program reporting requirements. This
application of the reporting ratio to the national unadjusted and
minimum unadjusted copayments is calculated according to Sec. 419.41
of our regulations, prior to any adjustment for a hospital's failure to
meet the quality reporting standards according to Sec. 419.43(h).
Beneficiaries and secondary payers thereby share in the reduction of
payments to these hospitals.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68772), we established the policy that all other applicable adjustments
to the OPPS national unadjusted payment rates apply in those cases when
the OPD fee schedule increase factor is reduced for hospitals that fail
to meet the requirements of the Hospital OQR Program. For example, the
following standard adjustments apply to the reduced national unadjusted
payment rates: The wage index adjustment; the multiple procedure
adjustment; the interrupted procedure adjustment; the rural sole
community hospital adjustment; and the adjustment for devices furnished
with full or partial credit or without cost. We believe that these
adjustments continue to be equally applicable to payments for hospitals
that do not meet the Hospital OQR Program requirements. Similarly, OPPS
outlier payments made for high cost and complex procedures will
continue to be made when the criteria are met. For hospitals that fail
to meet the quality data reporting requirements, the hospitals' costs
are compared to the reduced payments for purposes of outlier
eligibility and payment calculation. This policy conforms to current
practice under the IPPS. We continued this policy in the CY 2010 OPPS/
ASC final rule with comment period (74 FR 60642), in the CY 2011 OPPS/
ASC final rule with comment period (75 FR 72099), and in the CY 2012
OPPS/ASC final rule with comment period (76 FR 74478). For a complete
discussion of the OPPS outlier calculation and eligibility criteria, we
refer readers to section II.G. of this final rule with comment period.
2. Reporting Ratio Application and Associated Adjustment Policy for CY
2013
In the CY 2013 OPPS/ASC proposed rule (77 FR 45182), we proposed to
continue our established policy of applying the reduction of the OPD
fee schedule increase factor through the use of a reporting ratio for
those hospitals that fail to meet the Hospital OQR Program requirements
for the full CY 2013 annual payment update factor. For the CY 2013
OPPS, the reporting ratio is 0.980, calculated by dividing the reduced
conversion factor of $69.887 by the full conversion factor of $71.313.
We proposed to continue to apply the reporting ratio to all services
calculated using the OPPS conversion factor. For the CY 2013 OPPS, we
proposed to apply the reporting ratio, when applicable, to all HCPCS
codes to which we have assigned status indicators ``P,'' ``Q1,''
``Q2,'' ``Q3,'' ``R,'' ``S,'' ``T,'' ``V,'' ``U,'' and ``X'' (other
than new technology APCs to which we have assigned status indicators
``S'' and ``T''). We proposed to continue to exclude services paid
under New Technology APCs. We proposed to continue to apply the
reporting ratio to the national unadjusted payment rates and the
minimum unadjusted and national unadjusted copayment rates of all
applicable services for those hospitals that fail to meet the Hospital
OQR Program reporting requirements. We also proposed to continue to
apply all other applicable standard adjustments to the OPPS national
unadjusted payment rates for hospitals that fail to meet the
requirements of the Hospital OQR Program. Similarly, we proposed to
continue to calculate OPPS outlier eligibility and outlier payment
based on the reduced payment rates for those hospitals that fail to
meet the reporting requirements.
We invited public comments on these proposals. We did not receive
any public comments on our CY 2013 proposal to apply the Hospital OQR
Program reduction in the manner described above and, therefore, are
finalizing our proposal, without modification.
Therefore, for the CY 2013 OPPS, we are applying a reporting ratio
of 0.980 to the national unadjusted payments, minimum unadjusted
copayments, and national unadjusted copayments for all applicable
services for those hospitals failing to meet the Hospital OQR Program
reporting requirements. This reporting ratio applies to HCPCS codes
assigned status indicators ``P,'' ``Q1,'' ``Q2,'' ``Q3,'' ``R,'' ``S,''
``T,'' ``U,'' ``V,'' or ``X,'' excluding services paid under New
Technology APCs. All other applicable standard adjustments to the OPPS
national unadjusted payment rates for hospitals that fail to meet the
requirements of the Hospital OQR Program will continue to apply. We
continue to calculate OPPS outlier eligibility and outlier payment
based on the reduced rates for those hospitals that fail to meet the
reporting requirements.
G. Requirements for Reporting of Hospital OQR Data for the CY 2014
Payment Determination and Subsequent Years
1. Administrative Requirements for the CY 2014 Payment Determination
and Subsequent Years
In order to participate in the Hospital OQR Program, hospitals must
meet administrative, data collection and submission, and data
validation requirements (if applicable). Hospitals that do not meet
Hospital OQR Program requirements, as well as hospitals not
participating in the program and hospitals that withdraw from the
program, will not receive the full OPPS
[[Page 68481]]
payment rate update. Instead, in accordance with section 1833(t)(17)(A)
of the Act, those hospitals will receive a reduction of 2.0 percentage
points to their OPD fee schedule increase factor for the applicable
payment year.
We established administrative requirements for the payment
determination requirements for the CY 2013 and subsequent years'
payment updates in the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74479 through 74487).
In the CY 2013 OPPS/ASC proposed rule (77 FR 45182), with respect
to the payment determinations for CY 2014 and subsequent years, we
proposed one modification to these requirements. Under current
requirements, CMS deadlines for hospitals to submit notice of
participation forms are based on the date identified as a hospital's
Medicare acceptance date on the CMS Certification and Survey Provider
Enhanced Reporting (CASPER) system. Deadlines are based on whether a
hospital's Medicare acceptance date falls before January 1 of the year
prior to the annual payment update, or on or after January 1 of the
year prior to the annual payment update (for example, 2013 would be the
year prior to the affected CY 2014 annual payment update). Currently,
for a hospital whose Medicare acceptance date is before January 1 of
the year prior to the affected payment update affected, the notice of
participation form is due by March 31 of the year prior to the affected
annual payment update (76 FR 74479 through 74480). We proposed to
extend this deadline for hospitals, as described below.
Hospitals with Medicare acceptance dates before January 1 of the
year prior to the affected annual payment update: For the CY 2014 and
subsequent years payment update, we proposed that any hospital that has
a Medicare acceptance date before January 1 of the year prior to the
affected annual payment update (for example, 2013 would be the year
prior to the affected CY 2014 annual payment update) that is not
currently participating in Hospital OQR and wishes to participate in
the Hospital OQR Program must submit a participation form by July 31,
rather than March 31, of the year prior to the affected annual payment
update. We proposed a deadline of July 31 to give hospitals the maximum
amount of time to decide whether they wish to participate in the
Hospital OQR Program, as well as put into place the necessary staff and
resources to timely report chart-abstracted data for the first quarter
of the year's services which are due August 1.
We invited public comment on this proposed modification to Hospital
OQR Program administrative requirements for the CY 2014 and subsequent
years' payment determinations.
Comment: Several commenters supported the proposal to extend the
deadline to submit a participation form for a hospital that is not
currently participating in Hospital OQR and wishes to participate in
OQR to July 31, rather than March 31, of the year prior to the affected
annual payment update.
Response: We thank these commenters for supporting our proposal to
extend the deadline for submitting a participation form for a hospital
that is not currently participating in Hospital OQR and wishes to
participate.
After consideration of the public comments received, we are
finalizing our proposal to extend the deadline for a hospital that is
not currently participating in the Hospital OQR Program and wishes to
participate in the Program to submit a participation form by July 31,
rather than March 31, of the year prior to the affected annual payment
update.
2. Form, Manner, and Timing of Data Submitted for the Hospital OQR
Program for the CY 2014 Payment Determination and Subsequent Years
a. Background
In the CY 2013 OPPS/ASC proposed rule (77 FR 45182), we did not
propose any additional measures for the CY 2014 payment determination
year. We refer readers to the following OPPS/ASC final rules with
comment periods for a history of measures adopted for the Hospital OQR
Program, including lists of: 11 measures finalized for the CY 2011
payment determination (74 FR 60637); 15 measures finalized for the CY
2012 payment determination (75 FR 72083 through 72084); 23 measures
finalized for the CY 2013 payment determination (75 FR 72090); and 26
measures finalized for the CY 2014 and CY 2015 payment determinations
(76 FR 74469 and 74473).
Because of the clarification in the measure table in section XV.D
above that public reporting for OP-15: Use of Brain Computed Tomography
(CT) in the Emergency Department for Atraumatic Headache is not planned
until July 2013 at the earliest, we confirm this measure will not be
used in the CY 2014 payment determination. We will confirm our intent
to include or exclude this measure in the CY 2015 payment determination
in future rulemaking.
We refer readers to section XV.C.2 of this final rule with comment
period for a discussion of measure OP-16: Troponin Results for
Emergency Department acute myocardial infarction (AMI) patients or
chest pain patients (with Probable Cardiac Chest pain) Received Within
60 minutes of Arrival. Due to a patient safety concern, this measure
has been removed from the OQR Program measure set.
We refer readers to section XV.C.3. of this final rule with comment
period for a discussion of measure OP-19: Transition Record with
Specified Elements Received by Discharged ED Patients. Because the data
collection for this measure is currently suspended, this measure will
not be used in the CY 2014 payment determination. We will indicate
whether data collection for this measure will resume in time for the CY
2015 payment determination in future rulemaking.
We refer readers to section XV.C.4. of this final rule with comment
period for a discussion of measure OP-24: Cardiac Rehabilitation
Patient Referral From an Outpatient Setting. We proposed not to use
this measure in the CY 2014 payment determination and deferred data
collection for this measure until the CY 2015 payment determination.
b. General Requirements
In the CY 2013 OPPS/ASC proposed rule (77 FR 45183), we proposed to
continue the policy that, to be eligible to receive the full OPD fee
schedule increase factor for any payment determination, hospitals must
comply with our submission requirements for chart-abstracted data,
population and sampling data, claims-based measure data, and structural
quality measure data, including all-patient volume data. We refer
readers to the CY 2012 OPPS/ASC final rule with comment period (76 FR
74480 through 74482) for a discussion of these requirements.
c. Chart-Abstracted Measure Requirements for CY 2014 and Subsequent
Payment Determination Years
The table in section XV.D. of this final rule with comment period
includes measures that are collected by abstracting the information
from patient charts. In this final rule with comment period, we are
confirming removal of one chart-abstracted measure from the program,
OP-16: Troponin Results for Emergency Department acute myocardial
infarction (AMI) patients or chest pain patients (with Probable Cardiac
Chest Pain) Received Within 30 minutes of Arrival. For a full
discussion of this removal, please refer to section XV.C.2. of this
final rule with comment period.
[[Page 68482]]
Comment: Several commenters supported the proposal not to collect
data for measures that CMS proposed to exclude from the CY 2014 payment
determination.
Response: We thank the commenters for supporting our proposal
regarding collection of data for measures which are to be excluded from
the CY 2014 payment determination. A discussion of measures that are
under review or have been removed from the program is found in section
XV.C. above.
After consideration of the public comments received, we are
finalizing our proposal to exclude chart abstracted measures OP-19 and
OP-24, from the CY 2014 payment determination. In addition, in this
final rule with comment period, we are confirming the removal of chart-
abstracted measure OP-16. Thus, the following chart-abstracted measures
remain in the Hospital OQR Program and data for these measures is
required for the CY 2014 payment determination:
OP-1: Median Time to Fibrinolysis
OP-2: Fibrinolytic Therapy Received Within 30 Minutes
OP-3: Median Time to Transfer to Another Facility for
Acute Coronary Intervention
OP-4: Aspirin at Arrival
OP-5: Median Time to ECG
OP-6: Timing of Antibiotic Prophylaxis
OP-7: Prophylactic Antibiotic Selection for Surgical
Patients
OP-18: Median Time from ED Arrival to ED Departure for
Discharged ED Patients
OP-20: Door to Diagnostic Evaluation by a Qualified
Medical Professional
OP-21: ED--Median Time to Pain Management for Long Bone
Fracture
OP-22: ED Patient Left Without Being Seen
OP-23: ED--Head CT Scan Results for Acute Ischemic Stroke
or Hemorrhagic Stroke who Received Head CT Scan Interpretation Within
45 Minutes of Arrival
Of those measures for which we proposed to collect data for in CY
2014, the form and manner for submission of one of these measures, OP-
22: ED Patient Left Without Being Seen, is unique, and the form and
manner for this measure is detailed in section XV.G.2.f. of this final
rule with comment period.
For the chart-abstracted measures for which we have finalized that
we will collect data for the CY 2014 payment determination, we proposed
that the applicable quarters for data collection would be as follows:
3rd quarter CY 2012, 4th quarter CY 2012, 1st quarter CY 2013, and 2nd
quarter CY 2013 for hospitals that are continuing participants; newly
participating hospitals would follow reporting requirements as outlined
in the CY 2012 OPPS/ASC final rule with comment period (76 FR 74480)
and in section XV.G.1. of this final rule with comment period.
In general, submission deadlines would be approximately 4 months
after the last day of each calendar quarter. Thus, for example, the
submission deadline for data for services furnished during the first
quarter of CY 2013 (January-March 2013) would be on or around August 1,
2013. We proposed to post actual submission deadlines on the http://www.QualityNet.org Web site.
Hospitals that did not participate in the CY 2013 Hospital OQR
Program, but would like to participate in the CY 2014 Hospital OQR
Program, and that have a Medicare acceptance date on the CASPER system
before January 1, 2013, would begin data submission with respect to 1st
quarter CY 2013 encounters using the previously adopted measures which
we are retaining for the CY 2014 payment determination, found in the
table in section XV.D above. For those hospitals with Medicare
acceptance dates on or after January 1, 2013, data submission must
begin with the first full quarter following the submission of a
completed online participation form.
For the CY 2015 payment determination, we proposed that the
applicable quarters for previously finalized chart-abstracted measures
would be as follows: 3rd quarter CY 2013, 4th quarter CY 2013, 1st
quarter CY 2014, and 2nd quarter CY 2014.
Hospitals that did not participate in the CY 2014 Hospital OQR
Program, but would like to participate in the CY 2015 Hospital OQR
Program, and that have a Medicare acceptance date on the CASPER system
before January 1, 2014, would begin data submission with respect to 1st
quarter CY 2014 encounters using the previously adopted measures which
we are retaining for the CY 2015 payment determination, found in the
table in section XV.D above. For those hospitals with Medicare
acceptance dates on or after January 1, 2014, data submission must
begin with the first full quarter following the submission of a
completed online participation form. We invited public comments on
these proposals.
Comment: Some commenters encouraged CMS to improve alignment among
CMS quality reporting programs; specifically, they would like to see
alignment of data submission deadlines and encounter/discharge periods.
These commenters urged CMS to review its programs for opportunities to
harmonize program design. These commenters stated their belief that
aligning program design and measures supports stakeholders in
fulfilling CMS' requirements, whereas lack of alignment results in
stakeholders competing for resources to fulfill requirements.
Response: We thank these commenters for their suggestions. We agree
that end users and stakeholders, especially those that fulfill
reporting requirements for multiple programs, would benefit from
standardized program requirements.
Besides the Hospital OQR Program, we have a significant number of
quality data reporting or incentive programs. Currently, we are working
on integrating the Hospital OQR, Hospital Inpatient Quality Reporting
(IQR) Program, and the Hospital Value-Based Purchasing (VBP) Program
more fully to meet the requirements of the Health Information
Technology for Economic and Clinical Health Act. This statute promotes
driving transformation through the adoption and use of health
information technology (HIT), electronic health records (EHR) and
health information organizations (HIOs)
We agree with commenters that alignment is important to reduce
stakeholder burden, and we will also continue to consider opportunities
to align program requirements for programs outside of the Hospital OQR,
IQR, and VBP Programs.
Comment: Many commenters supported the proposed data submission
deadlines for chart-abstracted measures.
Response: We thank these commenters for supporting the proposed
deadlines.
After consideration of the public comments we received, we are
finalizing our proposals for the applicable quarters for chart
abstracted measures for the CY 2014 and CY 2015 payment determinations
and for subsequent years. We are finalizing our proposals for
submission deadlines for chart abstracted data for the CY 2014 payment
determination and for subsequent years, and for posting these deadlines
on the QualityNet Web site. We are finalizing our proposals for
hospitals who are newly participating or who are resuming participation
in the OQR program to submit a notice of participation and begin
submitting data to the OQR Program.
d. Claims-Based Measure Data Requirements for the CY 2014 and CY 2015
Payment Determinations
The table in section XV.D. of this final rule with comment period
includes
[[Page 68483]]
measures that the Hospital OQR Program collects by accessing electronic
claims data submitted by hospitals for reimbursement.
OP-15 is a claims-based measure that has not been implemented for
public reporting through rulemaking (76 FR 74456), and it is not
required for the CY 2014 payment determination.
Therefore, the 6 remaining claims-based measures set out below will
be included for the CY 2014 payment determination:
OP-8: MRI Lumbar Spine for Low Back Pain
OP-9: Mammography Follow-up Rates
OP-10: Abdomen CT--Use of Contrast Material
OP-11: Thorax CT--Use of Contrast Material
OP-13: Cardiac Imaging for Preoperative Risk Assessment
for Non Cardiac Low Risk Surgery
OP-14: Simultaneous Use of Brain Computed Tomography (CT)
and Sinus Computed Tomography (CT)
We will continue our policy of calculating the measures using the
hospital's Medicare claims data as specified in the Hospital OQR
Specifications Manual; therefore, no additional data submission is
required for hospitals. In the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74483), we stated that for the CY 2013 and CY 2014
payment updates, we will use paid Medicare FFS claims for services
furnished from January 1, 2010 to December 31, 2010 and January 1, 2011
to December 31, 2011, respectively.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45184), for the CY
2015 Hospital OQR payment determination, we proposed to use paid
Medicare FFS claims for services from a 12-month period from July 1,
2012 through June 30, 2013 for the calculation of the claims-based
measures. While this would be a departure from the traditional 12-month
calendar year period we have used for these measures, we proposed this
period in order to align the data period for inpatient and outpatient
claims based measures reported on the Hospital Compare Web site, and
also to be able to post more recent data for the outpatient imaging
efficiency on the Web site. We invited public comment on this proposal.
Comment: Some commenters supported the proposal to move away from
the traditional 12-month data period to align the data period for
inpatient and outpatient claims based measures reported on the Hospital
Compare Web site, and also to be able to post more recent data for the
outpatient imaging efficiency on the Web Site.
Response: We thank these commenters for supporting our efforts to
align the data collection period for the Hospital OQR Program with that
of the Hospital IQR Program.
Comment: One commenter questioned why CMS needs such a long delay
in claims utilization. This commenter believed that CY 2011 claims are
not appropriate to use in the CY 2014 payment determination.
Response: We have proposed to adjust the time period of when
services are furnished; doing so moves the period away from the
traditional January-December time period to make it six months more
current. Regarding the data lag for claims based data, for the CY 2015
payment determination year, we proposed using paid, FFS claims for
services during the time period from July 1, 2012 through June 30,
2013. Calculations based on this time period would be publicly reported
on Hospital Compare in July 2014, and we would make actual payment
determinations for the CY 2015 payment year on or around December 1,
2014.
For claims from the period July 1, 2012 through June 30, 2013, the
data lag, or time elapsed until payment determination is made, is
approximately 17 months at the longest (for data from July 1, 2012) to
5 months at shortest (for data from June 30, 2013). This is due to
several factors. First, we allow three months after the last date of
service to pass before pulling the data extract for claims based
measures in order to ensure that we are capturing most of the final
paid claims through the last date of service (in this example, the last
date of service is June 30, 2012). Second, it takes three to six months
to build our analytic files for the measures, generate calculations,
and ensure their accuracy. For some claims-based measures, we generate
and deliver detailed confidential reports for hospitals. About two
months prior to public reporting, we allow 30 days for hospitals to
preview their data, after which we deliver final public reporting files
for the Hospital Compare Web site.
With our proposal, we believe we have adequately balanced the need
for current data with the need to have a stable set of FFS claims data
for a payment determination and a preview process that takes into
account the needs of hospital stakeholders.
Comment: One commenter believed that there is an inconsistency in
the use of Medicare claims versus data from all patients. According to
the commenter, CMS stated that it will use only Medicare FFS claims for
structural measures, but proposes to use data from all patients (for
example, including non-Medicare patients) for other measures.
Response: We do not use Medicare FFS claims for structural
measures. For structural measures, hospitals currently review the time
period covered in the reporting period to answer questions about
registry use, safe surgery checklist use, etc. The structural measures
in the Hospital OQR Program apply to the hospital outpatient department
setting.
For clarification, the Hospital OQR chart-abstracted measures apply
to all patients meeting the inclusion criteria for the measure
regardless of payer, while the claims-based measures are calculated
using only Medicare FFS claims. The structural measures apply to the
hospital outpatient department.
We require hospitals to complete and submit a registration form
(``participation form'') in order to participate in the Hospital OQR
Program. With submission of this participation form, participating
hospitals agree that they will allow us to publicly report the quality
measure data submitted under the Hospital OQR Program, including
measures that we calculate using Medicare claims and all other
submitted data, including non-Medicare data.
After consideration of the public comments we received, we are
finalizing our proposals for the data periods we will use for claims-
based measures for the CY 2014 and CY 2015 payment determinations.
e. Structural Measure Data Requirements for the CY 2014 Payment
Determination and Subsequent Years
A summary of the previously finalized structural measures that we
require for the CY 2014 and subsequent years payment determinations is
set out below:
OP-12: The Ability for Providers With HIT To Receive
Laboratory Data Electronically Directly Into Their Qualified/Certified
EHR System as Discrete Searchable Data
OP-17: Tracking Clinical Results Between Visits
OP 25: Safe Surgery Check List Use
OP 26: Hospital Outpatient Volume on Selected Outpatient
Surgical Procedures
We previously finalized that for the CY 2014 payment determination,
hospitals will be required to submit data on all structural measures
between July 1, 2013 and August 15, 2013 with respect to the time
period from January 1, 2012 to December 31, 2012. In the CY 2013 OPPS/
ASC proposed rule (77 FR 45184), we proposed to extend this submission
deadline. Under this
[[Page 68484]]
proposed change, for the CY 2014 payment determination, hospitals would
be required to submit data on all structural measures between July 1,
2013 and November 1, 2013 with respect to the time period from January
1, 2012 to December 31, 2012. In section XV.G.2.f. of this final rule
with comment period, we describe how this proposal would likewise
extend the deadline to submit data for OP-22: ED Patient Left Without
Being Seen. We proposed to continue this schedule so that, for the CY
2015 payment determination, hospitals would be required to submit data
on all structural measures between July 1, 2014 and November 1, 2014
with respect to the time period from January 1, 2013 to December 31,
2013. We invited public comments on these proposals.
Comment: Two commenters supported the change in the 12-month period
because it better aligns the reporting period with that of other claims
based measures displayed on Hospital Compare.
Response: We agree that this alignment is beneficial and we seek to
align programs to the extent possible. We are finalizing this policy as
proposed.
After consideration of the public comments we received, we are
finalizing the proposal that, for the CY 2014 payment determination,
hospitals would be required to submit data on all structural measures
between July 1, 2013 and November 1, 2013 with respect to the time
period from January 1, 2012 to December 31, 2012, and for the CY 2015
payment determination, hospitals would be required to submit data on
all structural measures between July 1, 2014 and November 1, 2014 with
respect to the time period from January 1, 2013 to December 31, 2013.
f. Data Submission Requirements for OP-22: ED Patient Left Without
Being Seen for the CY 2015 Payment Determination
OP-22: ED Patient Left Without Being Seen is a chart-abstracted
measure for which aggregate data is collected via a Web-based tool, as
previously finalized. In other words, for purposes of data collection,
this measure is treated like a structural measure. For this reason, it
is collected on the same schedule as the structural measures described
above, and, in the CY 2013 OPPS/ASC proposed rule (77 FR 45184) we
proposed to extend the submission window for all structural measures,
including OP-22. In the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74485), with respect to OP-22, we stated that hospitals would be
required to submit data once for the CY 2014 payment determination via
a Web-based tool located on the QualityNet Web site. For the CY 2014
payment determination, we proposed that hospitals would be required to
submit data, including numerator and denominator counts, between July
1, 2013 and November 1, 2013 (comparable to the submission window that
we proposed for the structural measures data collection in the section
above) with respect to the time period of January 1, 2012 to December
31, 2012.
For the CY 2015 payment determination, we proposed to continue this
policy. Hospitals would be required to submit data between July 1, 2014
and November 1, 2014 with respect to the time period of January 1, 2013
to December 31, 2013. We invited public comment on these proposals.
Comment: Some commenters opposed data collection for OP-22: ED
Patient Left Without Being Seen. These commenters noted that OP-22 is
not NQF-endorsed and believed it is not a clear measure of quality of
care for a variety of reasons: Because there are credible reasons why a
patient might choose to leave an ER prior to treatment; the measure
disadvantages ED's in areas where an ED is used as a primary care
facility; and there are no underlying patient records to validate this
data.
Response: We thank the commenters for their feedback. Please refer
to section XV.C.1 of this final rule with comment period for a
discussion of measure OP-22.
After consideration of the public comments we received, we are
finalizing our proposal to extend the data submission window for OP-22.
g. Population and Sampling Data Requirements for the CY 2014 Payment
Determination and Subsequent Years
In the CY 2013 OPPS/ASC proposed rule (77 FR 45184), for the CY
2014 payment determination and subsequent years, we proposed to
continue our policy that hospitals may submit voluntarily on a
quarterly basis, aggregate population and sample size counts for
Medicare and non-Medicare encounters for the measure populations for
which chart-abstracted data must be submitted, but they will not be
required to do so. Where hospitals do choose to submit this data, the
deadlines for submission are the same as those for reporting data for
chart-abstracted measures, and hospitals may also choose to submit data
prior to these deadlines. The deadline schedule is available on the
QualityNet Web site. We refer readers to the CY 2011 OPPS/ASC final
rule with comment period (75 FR 72101 through 72103) and the CY 2012
OPPS/ASC final rule with comment period (76 FR 74482 through 74483) for
discussions of these policies. We invited public comments on these
proposals.
Comment: One commenter appreciated the policy that program
participants can continue to submit population and sampling data
voluntarily.
Response: We believe there is no need to require the submission of
population and sampling data due to the high level of voluntary
submission of these data.
After consideration of the public comments we received, we are
finalizing our policies for population and sampling data requirements
for the CY 2014 payment determination and subsequent years.
3. Hospital OQR Program Validation Requirements for Chart-Abstracted
Measure Data Submitted Directly to CMS for the CY 2014 Payment
Determination and Subsequent Years
a. Random Selection of Hospitals for Data Validation of Chart-
Abstracted Measures for the CY 2014 Payment Determination and
Subsequent Years
In the CY 2012 OPPS/ASC final rule with comment period (76 FR 74484
through 74485), similar to our approach for the CY 2012 payment
determination (75 FR 72103 through 72106), we adopted a policy to
validate chart-abstracted patient-level data submitted directly to CMS
from randomly selected hospitals for the CY 2013 payment determination.
For the CY 2013 payment determination, we reduced the number of
randomly selected hospitals from 800 to 450.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45184), we proposed to
continue this policy for the CY 2014 payment determination and for
subsequent years. We refer readers to the CY 2012 OPPS/ASC final rule
with comment period (76 FR 74484) for a discussion of sample size,
eligibility for validation selection, and encounter minimums for chart
abstracted data submitted directly to CMS from randomly selected
hospitals. We invited public comment on this proposal.
Comment: One commenter was pleased that the number of hospitals
selected dropped from 800 to 450 for the CY 2013 payment determination.
Response: We thank this commenter for supporting our proposal to
maintain the sample size for hospitals selected for validation. We note
that in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53552)
[[Page 68485]]
the total base sample size of hospitals included in the annual
validation random sample has recently been reduced from 800 to 400, to
reduce overall burden. For both the Hospital IQR and Hospital OQR
Programs, we believe we can reduce the annual random sample size
without adversely affecting our ability to infer reliability of the
chart-abstracted clinical data submitted to the programs.
After consideration of the public comments we received, we are
finalizing our proposal to retain our sample size for hospitals
randomly selected for data validation of chart-abstracted measures for
the CY 2014 payment determination and subsequent years.
b. Targeting and Targeting Criteria for Data Validation Selection for
the CY 2014 Payment Determination and Subsequent Years
In the CY 2011 OPPS/ASC proposed rule (75 FR 46380) we discussed
applying, to CY 2013 and subsequent years' data submission, criteria to
determine whether a hospital would be included in our validation
selection based on abnormal data patterns or a specific situation. At
that time we provided, for public comment, specific examples of what we
thought could be appropriate criteria.
In the CY 2011 OPPS/ASC final rule with comment period (75 FR
72106) we stated our belief that the targeting criteria we shared for
comment were reasonable. We considered one commenter's concern that we
should use targeting criteria to ensure we do not over-select a
hospital for validation. We reiterated our intent to propose the
specific targeting criteria in the upcoming CY 2012 OPPS/ASC proposed
rule (76 FR 42332), in order to finalize and apply it to 2012 encounter
data collected for the CY 2013 validation process year. We did so, and
finalized our proposal without modification in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74485).
In summary, we finalized our intent to select a random sample of
hospitals for validation purposes, and to select an additional 50
hospitals based on specific criteria designed to measure whether the
data these hospitals have reported raises a concern regarding data
accuracy.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45185), for the CY
2014 payment determination and subsequent years, we proposed to
continue these policies and to continue to use the targeting criteria
finalized previously. Specifically, a hospital will be preliminarily
selected for validation based on targeting criteria if it:
Fails the validation requirement that applies to the
previous year's payment determination. For example, if a hospital was
selected for validation for the CY 2013 payment determination year,
either on a random or targeted basis, and the hospital did not meet the
75 percent validation score for the designated time period, based upon
our validation process, for the designated time period, the hospital
would be included in the targeted sample pool for the CY 2014 payment
determination); or
Has an outlier value for a measure based on the data it
submitted, based on finalized criteria from the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74485).
In the CY 2012 OPPS/ASC proposed rule (76 FR 42333) and CY 2012
OPPS/ASC final rule with comment period (76 FR 74486) we describe
additional data validation conditions under consideration for the CY
2014 payment determination and subsequent years. We thank those who
commented on the CY 2012 proposed additional data validation targeting
conditions and will take their views under consideration as we develop
any future proposals on these issues. In the CY 2013 OPPS/ASC proposed
rule (77 FR 45185), we did not propose any additional targeting
criteria to use in selecting the additional 50 hospitals we include in
the validation process for CY 2014 payment determination or in
subsequent years. We invited public comment on this proposal.
Comment: One commenter believed that CMS quality measures should be
based strictly on data derived either through claims or data
abstracting on the Medicare population, not on all patients who are
treated in the outpatient setting.
Response: Data submitted to the Hospital OQR Program are intended
to provide the public with information on as many patients treated in
the outpatient hospital setting as possible, including both Medicare
and non-Medicare patients. As noted above, however, claims-based data
collection is limited to Medicare FFS patients.
The Hospital OQR Program requires this data to be submitted under
section 1833(t)(17)(A) of the Act, which applies to hospitals as
defined under section 1886(d)(1)(B) of the Act. That provision states
that subsection (d) hospitals that do not report data required for the
quality measures selected by the Secretary in the form and manner
required by the Secretary will not receive the full payment rate
update. We modeled the Hospital OQR Program after the Hospital IQR
Program.
In order for us to evaluate the care of the Medicare population
which is a subset of the entire population, we look at data of the
whole population, to ensure Medicare beneficiaries are receiving the
same level of care as non-Medicare beneficiaries receive. Because we
collect chart-abstracted quality measure data on both Medicare and non-
Medicare patients, we believe it is appropriate to establish sampling
criteria that apply to the same populations, which include both
Medicare and non-Medicare patients.
Comment: One commenter advocated selecting a valid sample based on
local practice patterns, desiring inter-rater reliability. This
commenter suggested that CMS select all 450 hospitals using criteria
that measure whether the data hospitals have reported raises a concern
regarding accuracy.
Response: We interpret the commenter to be suggesting that sampling
criteria should be refined in order to reflect local practice patterns.
Because we use quality measures reflecting national consensus, we do
not believe that such further refinement is necessary. Regarding inter-
rater reliability, this should not be affected by the criteria used for
sample selection.
Comment: One commenter believed that our sample sizes would be
acceptable if they were the only Federal data submission requirement.
This commenter believed that the records requested by the Hospital OQR
Program are in addition to those that are already established as part
of the Federal integrity audit processes (for example, RAC, Medicaid
Integrity, ZPIC, and MAC). The commenter encourages CMS to review the
validation process with respect to other CMS data requirements.
Response: We understand the commenter's concern regarding multiple
Federal medical record requests. For Hospital OQR Program validation,
we have worked to limit overall burden by reducing the number of
hospitals participating annually in validation through our random
sampling of hospitals. In addition, hospitals are reimbursed for
photocopying and mailing costs. We agree that efforts should be made to
keep record requests for validation purposes at the minimum necessary
to ensure accuracy of submitted data.
We refer readers to section XV.J. Electronic Health Records (EHRs),
below, for a discussion of how Hospital IQR and Hospital OQR Programs
are transitioning to the use of certified EHR technology, for measures
that otherwise require information from the clinical
[[Page 68486]]
record. We look forward to the adoption of EHR technology as a means to
reduce burden, allowing us to collect data for measures without the
need for manual chart abstraction, and we will explore validating these
data in ways that likewise reduce burden to providers.
Comment: One commenter would like CMS to clearly identify whether a
record has been requested as a result of random selection or targeted
selection.
Response: We interpret this commenter's suggestion to mean that we
should indicate whether we selected a hospital for validation as a
result of random or targeted selection.
For example, because all hospitals are eligible for random
selection, a hospital that failed validation in one payment
determination year would not know whether it was selected for
validation in the subsequent payment determination year based on random
or targeted selection. The hospital might have been selected in either
of these categories.
We have refrained from noting on what basis a hospital is selected
on public Web sites, since our targeting criteria are based on possible
data quality issues.
However, we do have that information available. If a hospital would
like to understand why it was selected for validation, the hospital may
call the support contractor and request that information. Contact
information for the Hospital OQR support contractor is available at
https://qualitynet.org.
After consideration of the public comments we received, we are
finalizing our proposal not to include any additional targeting
criteria to use in selecting the additional 50 hospitals we include in
the validation process for the CY 2014 payment determination or in
subsequent years.
c. Methodology for Encounter Selection for the CY 2014 Payment
Determination and Subsequent Years
In the CY 2013 OPPS/ASC proposed rule (77 FR 45185), for each
selected hospital (random or targeted), we proposed to continue the
approach we adopted in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74485 through 74486) for the CY 2014 payment
determination and subsequent years. For the CY 2014 payment
determination, for each selected hospital (random or targeted), we
would continue to validate up to 48 randomly selected patient
encounters (12 per quarter; 48 per year) from the total number of
encounters that the hospital successfully submitted to the OPPS
Clinical Warehouse. If a selected hospital has submitted less than 12
encounters in one or more quarters, only those encounters available
would be validated. For each selected encounter, a designated CMS
contractor would request that the hospital submit the complete
supporting medical record documentation that corresponds to the
encounter. We refer readers to 42 CFR 482.24(c)(2) for a definition of
what is expected in a medical record submitted for validation. The
validation process requires full supporting medical documentation,
including ECG tapes and/or other pieces of a medical record that may
not be stored in a single location. The hospital must ensure a full
medical record goes to the contractor for accurate validation.
We continue to believe that validating a larger number of
encounters per hospital for fewer hospitals at the measure level has
several benefits. We believe that this approach is suitable for the
Hospital OQR Program because it will: (1) Produce a more reliable
estimate of whether a hospital's submitted data have been abstracted
accurately; (2) provide more statistically reliable estimates of the
quality of care delivered in each measured hospital as well as at a
national level; and (3) reduce overall burden, for example, in
submitting validation documentation, because hospitals most likely will
not be selected to undergo validation each year, and a smaller number
of hospitals per year will be selected.
For all selected hospitals, we would not be selecting cases
stratified by measure or topic; our interest is whether the data
submitted by hospitals accurately reflects the care delivered and
documented in the medical record, not what the accuracy is by measure
or whether there are differences by measure or topic. We would be
validating data from April 1 to March 31 of the year preceding the
payment determination year. This provides validation results data in
time to use to make the payment determination. For example, encounter
data from April 1, 2012 to March 31, 2013 provides a full year of the
most recent data possible to validate in time to make the CY 2014
payment determination. We invited public comment on our proposal to
continue to use our established methodology for encounter selection and
to continue to use our annual schedule for encounters to be validated
and used in payment determinations.
We did not receive any public comments regarding our proposal to
continue to use our established methodology for encounter selection and
our annual schedule for encounters to be validated and used in payment
determinations. As a result, we are finalizing our proposal to continue
to use our established methodology for encounter selection and our
annual schedule for encounters to be validated and used in payment
determinations.
d. Validation Score Calculation for the CY 2014 Payment Determination
and Subsequent Years
In the CY 2013 OPPS/ASC proposed rule (77 FR 45185) we proposed to
retain the medical record return policy that we finalized in the CY
2011 OPPS/ASC final rule with comment period (75 FR 72104) for the CY
2014 payment determination and subsequent years. For the CY 2014
payment determination, we proposed to continue the validation score
policies we adopted in the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74486), for the CY 2013 payment determination. We
proposed to use the validation calculation approach finalized for the
CY 2012 and CY 2013 payment determinations with validation being done
for each selected hospital. Specifically, we proposed to conduct a
measures level validation by calculating each measure within a
submitted record using the independently abstracted data and then
comparing this to the measure reported by the hospital; a percent
agreement would then be calculated. We would also compare the measure
category for quality measures with continuous units of measurement,
such as time, so that for these measures, both the category and the
measure would need to match.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45185), for the CY
2014 payment determination and subsequent years, we proposed to use the
medical record validation procedure we finalized in the CY 2011 OPPS/
ASC final rule with comment period (75 FR 72105). A designated CMS
contractor would, for each quarter that applies to the validation, ask
each of the selected hospitals to submit medical documentation for up
to 12 randomly selected cases submitted to and accepted by the OPPS
Clinical Warehouse. The CMS contractor would request paper copies of
medical documentation corresponding to selected cases from each
hospital via certified mail or another trackable method that requires a
hospital representative to sign for the request letter. A trackable
method would be used so that we would be assured that the hospital
received the request. The hospital would have 45 calendar days from the
date of the request as documented in the request letter to submit the
requested documentation and have the documentation received by the CMS
contractor. If the hospital does
[[Page 68487]]
not comply within 30 calendar days of receipt of the initial medical
documentation request, the CMS contractor would send a second letter by
certified mail or other trackable method to the hospital, reminding the
hospital that paper copies of the requested documentation must be
submitted and received within 45 calendar days following the date of
the initial CMS contractor request. If the hospital does not submit the
requested documentation and the documentation is not received by the
CMS contractor within the 45 calendar days, then the CMS contractor
would assign a ``zero'' score to each data element for each selected
case and the case would fail for all measures in the same topic (for
example, OP-6 and OP-7 measures for a Surgical Care case).
We proposed that the letter from the designated CMS contractor
would be addressed to the hospital's medical record staff identified by
the hospital for the submission of records under the Hospital IQR
Program (that is, the hospital's medical records staff identified by
the hospital to its State QIO). If CMS has evidence that the hospital
received both letters requesting medical records, the hospital would be
deemed responsible for not returning the requested medical record
documentation and the hospital would not be allowed to submit such
medical documentation as part of its reconsideration request so that
information not utilized in making a payment determination is not
included in any reconsideration request.
Once the CMS contractor receives the requested medical
documentation, the contractor would independently reabstract the same
quality measure data elements that the hospital previously abstracted
and submitted, and the CMS contractor would then compare the two sets
of data to determine whether the two sets of data match. Specifically,
the CMS contractor would conduct a measures level validation by
calculating each measure within a submitted case using the
independently reabstracted data and then comparing this to the measure
reported by the hospital; a percent agreement would then be calculated.
The validation score for a hospital would equal the total number of
measure matches divided by the total number of measures multiplied by
100 percent.
We invited public comment on our proposals regarding the medical
record request policy for the CY 2014 payment determination and
subsequent payment determination years.
Comment: Many commenters supported our proposal to continue the 45
day time period for medical record submission. These commenters noted
that they appreciated the Hospital OQR Program's consistency with the
RAC auditing.
Response: We thank these commenters for their support. We agree
that the 45 day time period to submit medical record documentation for
validation is reasonable and has the additional benefit of being
consistent with RAC medical documentation requests.
To receive the full OPPS OPD fee schedule increase factor for CY
2014, we proposed that hospitals must attain at least a 75 percent
reliability score, based upon the proposed validation process. We
proposed to use the upper bound of a two-tailed 95 percent confidence
interval to estimate the validation score. If the calculated upper
limit is above the required 75 percent reliability threshold, we would
consider a hospital's data to be ``validated'' for payment purposes.
Because we are more interested in whether the measure has been
accurately reported, we would continue to focus on whether the measure
data reported by the hospital matches the data documented in the
medical record as determined by our reabstraction.
We proposed to calculate the validation score using the same
methodology we finalized for the CY 2012 and CY 2013 payment
determinations (75 FR 72105 and 76 FR 74486). We also proposed to use
the same medical record documentation submission procedures that we
also finalized for the CY 2012 and CY 2013 payment determinations (75
FR 72104 and 76 FR 74486). We invited public comments on these
proposals.
Comment: One commenter expressed concerns regarding the strict
validation of ED throughput measures, and recommended that CMS adopt
the 5 minute allowance for the Hospital OQR Program, which was
previously adopted for the Hospital IQR Program.
Response: We thank this commenter for expressing this concern. We
believe the commenter is referring to our policy requiring validation
of measures requiring time values. The commenter is referring to the FY
2013 IPPS/LTCH PPS final rule (77 FR 53549).
We agree with the commenter that requiring time values to match
exactly is not realistic based on our historical experience with
clinical data abstraction, the recognition that hospital clocks may
vary from system to system such that the same time may be recorded
differently depending on the source, and the limited clinical
significance of small deviations in time. We note that this particular
concern affects the validation score for the CY 2014 payment
determination as well as for future years.
Accordingly, we are finalizing that, for the CY 2014 payment
determination and for subsequent years, we will not require, when
scoring the following chart-abstracted measures, that these measures
have matching numerator and denominator states:
OP-18: Median Time from ED Arrival to ED Departure for
Discharged ED Patients
OP-19: Transition Record with Specified Elements Received
by Discharged ED Patients (this measure is currently suspended and will
not be used in the CY 2014 payment determination. We intend to confirm
whether this measure will be included in future payment determinations
in future rulemaking).
OP-20: Door to Diagnostic Evaluation by a Qualified
Medical Professional
OP-21: ED--Median Time to Pain Management for Long Bone
Fracture
OP-22: ED Patient Left Without Being Seen
OP-23: ED--Head CT Scan Results for Acute Ischemic Stroke
Instead, for scoring of these measures, we will allow a 5 minute
variance between the time abstracted by the hospital and that
abstracted by the Clinical Data Abstraction Center (CDAC).
After consideration of the public comments we received, we are
finalizing our proposals as modified regarding the validation score
calculation methodology and timeframe for submission of medical record
documentation requested for validation.
H. Hospital OQR Reconsideration and Appeals Procedures for the CY 2014
Payment Determination and Subsequent Years
When the Hospital IQR Program was initially implemented, it did not
include a reconsideration process for hospitals. Subsequently, we
received many requests for reconsideration of those payment decisions
and, as a result, established a process by which participating
hospitals could submit requests for reconsideration. We anticipated
similar concerns with the Hospital OQR Program and, therefore, in the
CY 2008 OPPS/ASC final rule with comment period (72 FR 66875), we
stated our intent to implement for the Hospital OQR Program a
reconsideration process modeled after the reconsideration process we
implemented for the Hospital IQR Program. In the CY 2009 OPPS/ASC final
rule with comment period (73 FR
[[Page 68488]]
68779), we adopted a reconsideration process that applied to the CY
2010 payment decisions. In the CY 2010 OPPS/ASC final rule with comment
period (74 FR 60654 through 60655), we continued this process for the
CY 2011 payment update. This process required that a hospital's CEO
sign any request for a reconsideration.
In the CY 2011 and CY 2012 OPPS/ASC final rules with comment
periods (75 FR 72106 through 72108 and 76 FR 74486 through 75587), we
continued this process for the CY 2012 and CY 2013 payment updates with
some modification. In the CY 2011 OPPS/ASC final rule with comment
period(75 FR 72107), we finalized that the CEO was not required to sign
the reconsideration request form.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45186), we proposed to
continue this process, with additional modifications, for the CY 2014
payment determination and subsequent years' payment determinations. We
have now realized that, in eliminating the requirement that a CEO sign
a request form, we did not include any requirement for a signature on
the reconsideration request form. To increase accountability, we
proposed for the CY 2014 payment determination and subsequent years'
payment determinations, that the hospital designate a contact on its
reconsideration request form, who may or may not be the CEO. We would
communicate with this designee. We also proposed that the hospital's
designee must sign its reconsideration request form. This process is
consistent with our recently adopted proposals for reconsideration
requests under the ASCQR Program (77 FR 53643 through 53644).
Under this process, a hospital seeking reconsideration must--
Submit to CMS, via QualityNet, a Reconsideration Request
form that will be made available on the QualityNet Web site; this form
must be submitted by February 3 of the affected payment year (for
example, for the CY 2014 payment determination, the request must be
submitted by February 3, 2014) and must contain the following
information:
[cir] Hospital CCN.
[cir] Hospital Name.
[cir] CMS-identified reason for not meeting the requirements of the
affected payment year's Hospital OQR Program as provided in any CMS
notification to the hospital.
[cir] Hospital basis for requesting reconsideration. This must
identify the hospital's specific reason(s) for believing it met the
affected year's Hospital OQR Program requirements and should receive
the full OPD fee schedule increase factor.
[cir] Designated hospital personnel contact information, including
name, email address, telephone number, and mailing address (must
include physical address, not just a post office box). We proposed that
the designee, who may or may not be the hospital's CEO, must sign the
form submitted to request reconsideration.
[cir] A copy of all materials that the hospital submitted to comply
with the requirements of the affected year's Hospital OQR Program. Such
material might include, but does not need to be limited to, the
applicable Notice of Participation form or completed online
registration form, and measure data that the hospital submitted via
QualityNet.
Paper copies of all the medical record documentation that
it submitted for the initial validation (if applicable). Hospitals
submit this documentation to a designated CMS contractor which has
authority to review patient level information. We post the address
where hospitals are to send this documentation on the QualityNet Web
site.
To the extent that the hospital is requesting
reconsideration on the basis that CMS has determined it did not meet an
affected year's validation requirement, the hospital must provide a
written justification for each appealed data element classified during
the validation process as a mismatch. Only data elements that affect a
hospital's validation score would be eligible to be reconsidered. We
review the data elements that were labeled as mismatched as well as the
written justifications provided by the hospital, and make a decision on
the reconsideration request.
We proposed these requirements for the CY 2014 payment
determination year program and for subsequent years. We invited public
comment on these proposed changes.
Comment: Many commenters supported the proposal that the CEO or
designee be able to sign the reconsideration request form.
Response: We thank these commenters for their support.
Following receipt of a request for reconsideration, CMS--
Provides an email acknowledgement, using the contact
information provided in the reconsideration request, to the designated
hospital personnel notifying them that the hospital's request has been
received.
Provides a formal response to the hospital-designated
personnel, using the contact information provided in the
reconsideration request, notifying the hospital of the outcome of the
reconsideration process.
Applies policies that we finalized for the CY 2012 and CY
2013 payment determinations regarding the scope of our review when a
hospital requests reconsideration because it failed our validation
requirement.
These policies are as follows:
If a hospital requests reconsideration on the basis that
it disagrees with a determination that one or more data elements were
classified as mismatches, we only consider the hospital's request if
the hospital timely submitted all requested medical record
documentation to the CMS contractor each quarter under the validation
process.
If a hospital requests reconsideration on the basis that
it disagrees with a determination that one or more of the complete
medical records it submitted during the quarterly validation process
was classified as an invalid record selection (that is, the CMS
contractor determined that one or more of the complete medical records
submitted by the hospital did not match what was requested), thus
resulting in a zero validation score for the encounter(s), our review
is initially limited. We would review only to determine whether the
medical documentation submitted in response to the designated CMS
contractor's request was the correct and complete documentation. If we
determine that the hospital did submit the correct and complete medical
documentation, we abstract the data elements and compute a new
validation score for the encounter. If we conclude that the hospital
did not submit the correct and complete medical record documentation,
we do not further consider the hospital's request.
If a hospital requests reconsideration on the basis that
it disagrees with a determination that it did not submit the requested
medical record documentation to the CMS contractor within the proposed
45 calendar day timeframe (which we are finalizing in this final rule
with comment period), our review is initially limited to determining
whether the CMS contractor received the requested medical record
documentation within 45 calendar days, and whether the hospital
received the initial medical record request and reminder notice. If we
determine that the CMS contractor timely received paper copies of the
requested medical record documentation, we abstract data elements from
the medical record documentation submitted by the
[[Page 68489]]
hospital and compute a validation score for the hospital. If we
determine that the hospital received two letters requesting medical
documentation but did not submit the requested documentation within the
45 calendar day period, we do not further consider the hospital's
request.
If a hospital is dissatisfied with the result of a Hospital OQR
reconsideration decision, the hospital is able to file an appeal under
42 CFR Part 405, Subpart R (PRRB appeal).
We invited public comment on the modifications we proposed to the
Hospital OQR Program reconsideration and appeals procedures.
Comment: One commenter thanked CMS for fully describing the process
for making a reconsideration request.
Response: We thank the commenter and appreciate the support. We
agree that the program process for reconsiderations should be clear and
fully described.
After consideration of the public comments we received, we are
finalizing our proposals to the Hospital OQR Program reconsideration
and appeals procedures.
I. Extraordinary Circumstances Extension or Waiver for the CY 2013
Payment Determination and Subsequent Years
In our experience, there have been times when hospitals have been
unable to submit required quality data due to extraordinary
circumstances that are not within their control. It is our goal to not
penalize hospitals for such circumstances and we do not want to unduly
increase their burden during these times. Therefore, in the CY 2010
OPPS/ASC final rule with comment period (74 FR 60046 through 600647),
we adopted a process for hospitals to request and for CMS to grant
extensions or waivers with respect to the reporting of required quality
data when there are extraordinary circumstances beyond the control of
the hospital. In the CY 2011 OPPS/ASC final rule with comment period
(75 FR 72103), we retained these procedures with a modification to
eliminate redundancy in the information a hospital must provide in the
request. In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74478 through 74479), for CY 2012 and subsequent years, we retained
these procedures with one modification. The CY 2012 modification
allowed that the original procedures for requesting an extension or
waiver of quality data submission would thereafter also extend to
include medical record documentation submission for purposes of
complying with our validation requirement for the Hospital OQR Program.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45187), we proposed to
retain these procedures with a modification for CY 2013 and subsequent
years.
We proposed to modify one element of the information required on
the CMS request form. Under the procedures set out in the CY 2012 OPPS/
ASC final rule with comment period (76 FR 74479), hospitals were
required to submit ``CEO and any other designated personnel contact
information'' (emphasis added), the CEO was required to sign the form,
and CMS was required to respond to the CEO and additional designated
hospital personnel. The information required in CY 2013 and subsequent
years would include ``CEO or other hospital-designated personnel
contact information'' (emphasis added). This proposed change would
allow the hospital to designate an appropriate, non-CEO, contact at its
discretion. This individual would be responsible for the submission,
and would be the one signing the form. Therefore, the hospital's
designated-contact may or may not hold the title of CEO. We invited
public comment on this proposed modification to the process for
granting extraordinary circumstances extensions or waivers for the
Hospital OQR Program.
Comment: Many commenters supported the proposal that the hospital
should designate its own most appropriate contact for the signing and
submission of the extraordinary circumstance extension and waiver form.
Response: We appreciate these commenters' support.
Thus, we proposed that, in the event of extraordinary
circumstances, such as a natural disaster, not within the control of
the hospital, for the hospital to receive consideration for an
extension or waiver of the requirement to submit quality data or
medical record documentation for one or more quarters, a hospital would
submit to CMS a request form that would be made available on the
QualityNet Web site. The following information should be noted on the
form:
Hospital CCN;
Hospital Name;
CEO or other hospital-designated personnel contact
information, including name, email address, telephone number, and
mailing address (must include a physical address, a post office box
address is not acceptable);
Hospital's reason for requesting an extension or waiver;
Evidence of the impact of the extraordinary circumstances,
including but not limited to photographs, newspaper and other media
articles; and
A date when the hospital would again be able to submit
Hospital OQR data and/or medical record documentation, and a
justification for the proposed date.
The request form would be signed by the hospital's designated
contact, whether or not that individual is the CEO. A request form
would be required to be submitted within 45 days of the date that the
extraordinary circumstance occurred.
Following receipt of such a request, CMS would--
(1) Provide an email acknowledgement using the contact information
provided in the request notifying the designated contact that the
hospital's request has been received;
(2) Provide a formal response to the hospital's designated contact
using the contact information provided in the request notifying them of
our decision; and
(3) Complete our review of any CY 2013 request and communicate our
response within 90 days following our receipt of such a request.
We note that we might also decide to grant waivers or extensions to
hospitals that have not requested them when we determine that an
extraordinary circumstance, such as an act of nature (for example,
hurricane) affects an entire region or locale. If we make the
determination to grant a waiver or extension to hospitals in a region
or locale, we would communicate this decision to hospitals and vendors
through routine communication channels, including but not limited to
emails and notices on the QualityNet Web site. We invited public
comments on these proposals.
Comment: One commenter thanked CMS for fully describing the process
for making a request for an extension or waiver of program
requirements.
Response: We thank this commenter for supporting our efforts.
After consideration of the public comments we received, we are
finalizing our proposed modifications to the procedures for requesting
an extension or waiver of Hospital OQR Program requirements.
J. Electronic Health Records (EHRs)
Starting with the FY 2006 IPPS final rule, we have encouraged
hospitals to take steps toward the adoption of EHRs (also referred to
in previous rulemaking documents as electronic medical records) that
will allow for reporting of clinical quality data from EHRs to a CMS
data repository (70 FR 47420 through 47421). We sought to prepare
[[Page 68490]]
for future EHR submission of electronic clinical quality measures
(eCQMs), as they are referred to in the EHR Incentive Program), by
sponsoring the creation of electronic specifications for eCQMs under
consideration for the Hospital IQR Program. Through the Medicare and
Medicaid EHR Incentive Programs, we expect that the submission of
quality data through EHRs will provide a foundation for establishing
the capacity of hospitals to send, and for CMS, in the future, to
receive, eCQMs via hospital EHRs for Hospital IQR Program and Hospital
OQR Program measures. We expect the Hospital IQR and Hospital OQR
Programs to transition to the use of electronic specifications for
eCQMs that otherwise require information from the clinical record. This
would allow us to collect data for eCQMs without the need for manual
chart abstraction.
In the FY 2012 IPPS/LTCH PPS proposed rule (75 FR 25894), we
identified FY 2015 as a potential transition date to move to EHR-based
submission and phase out manual chart abstraction for the Hospital IQR
Program. We also anticipate such a transition for hospital outpatient
measures, although likely somewhat after the transition for hospital
inpatient measures. This is because we hope to first align the eCQMs in
the Medicare EHR Incentive Program with the Hospital IQR Program
measures. Our goals are to align the hospital quality reporting
programs, to seek to avoid redundant and duplicative reporting of
quality measures for hospitals, and to rely largely on EHR submission
for many eCQMs based on clinical record data.
As noted below, the Medicare and Medicaid EHR Incentive Programs--
Stage 2 final rule (77 FR 54088) requires electronic reporting of eCQMs
beginning in 2014 for eligible hospitals and CAHs that are beyond the
first year of Stage 1 of meaningful use. Under our timeline for EHR-
based submission under the Hospital OQR Program, some eligible
hospitals would be in their second year of Stage 2 reporting and these
eligible hospitals could be using two methods to report similar
information for the Medicare and Medicaid EHR Incentive Programs and
the Hospital OQR Program. In the CY 2013 OPPS/ASC proposed rule (77 FR
45188), we stated that we had considered allowing, but not requiring,
EHR-based submission at the earliest possible date, so as to reduce the
burden of hospitals. We did not propose this approach because we
believe that it would not be consistent with our goal that measure
results that must be publicly reported should be based on consistent,
comparable results among reporting hospitals and because our first
priority is the align EHR-based submissions under the Hospital IQR
Program. We invited public comment on this issue.
Comment: A few commenters pointed out that the transition from
manual to electronic submission is a huge task and could be very labor
intensive. Another commenter stated that the timeline to transition to
electronic reporting is too aggressive. Some commenters urged CMS to
immediately allow data submission via chart abstraction or
electronically to ease the burden of quality reporting. Another
commenter agreed with CMS's consideration for a full migration to
electronic quality measurement and reporting. The commenter stated it
is inappropriate to report data using chart-abstraction and electronic
submission concurrently in the interim.
Response: We understand the transition to electronic submission is
an immense undertaking that requires intense collaboration among
stakeholders. As stated earlier, we still believe that public reporting
should be consistent and comparable among reporting hospitals. We
intend to move toward a full migration to electronic quality
measurement and reporting. In addition, the EHR Incentive Program has
incorporated eCQMs that are part of various hospital reporting
programs, including the Hospital IQR and Hospital OQR Programs, in
order to maximize financial incentives to help with this transition.
Comment: One commenter urged CMS to lay out its vision for
electronic reporting, stating that it is overly burdensome for
hospitals to collect and report data via chart abstraction and
electronically.
Response: We have previously stated our vision, including in the
Medicare and Medicaid EHR Incentive Programs--Stage 2 final rule (77 FR
54053). We noted that our alignment efforts focus on several fronts
including using the same eCQMs for different programs, standardizing
the measure development and electronic specification processes across
our programs, coordinating quality measurement stakeholder involvement
efforts, and identifying ways to minimize multiple submission
requirements and mechanisms. We gave the example that we are working
toward allowing eCQM data submitted via certified EHR technology
(CEHRT) by eligible professionals (EPs), eligible hospitals and CAHs to
apply to other CMS quality reporting programs. A longer-term vision
would be hospitals and clinicians reporting through a single, aligned
mechanism for multiple CMS programs. For EPs, we have finalized such an
alignment between the PQRS and the EHR Incentive Program, and we expect
hospital reporting programs such as Hospital IQR and Hospital OQR
Programs to follow.
In order to properly transition to electronic reporting, it is
imperative that we take a staggered approach to electronic reporting in
order to allow for careful review of the infrastructure and data
integrity during the process. We have and will continue to look for
ways to reduce reporting burden. We note that providers could collect
data in EHRs even if the submission of the data is not done
electronically for all quality reporting programs.
Comment: One commenter strongly recommended that all eCQMs should
be field-tested and validated prior to implementation.
Response: We agree with the commenter that eCQMs should be tested
and validated prior to implementation. We are collaborating with the
NQF, measure stewards, and the ONC to develop accurate, and medical-
record compatible electronic specifications while maintaining the
integrity of the measures as endorsed.
We thank the commenters for submitting comments on the use of EHRs
in the Hospital OQR Program and will take these comments into
consideration as we develop future policies on this issue.
K. 2013 Medicare EHR Incentive Program Electronic Reporting Pilot for
Eligible Hospitals and CAHs
In the CY 2012 OPPS/ASC final rule with comment period, we
finalized the voluntary 2012 Electronic Reporting Pilot for eligible
hospitals and CAHs participating in the Medicare EHR Incentive Program
for FY 2012 and also revised our regulations at Sec. 495.8(b)(2)
accordingly. We refer readers to the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74489 through 74492) for detailed discussion of
the 2012 Electronic Reporting Pilot.
We proposed to continue the Electronic Reporting Pilot for FY 2013
as finalized for FY 2012. We proposed to revise our regulations at
Sec. 495.8(b)(2)(vi) to reflect the continuation of the Electronic
Reporting Pilot for FY 2013, and also to remove the reference to Sec.
495.6(f)(9) in order to conform with the proposed changes to Sec.
495.6(f) that were included in the Medicare and Medicaid EHR Incentive
Programs--Stage 2 proposed rule (77 FR 13817). (We note we recently
published the Medicare and Medicaid EHR Incentive Programs--Stage 2
final rule
[[Page 68491]]
(77 FR 53968).)We invited public comments on these proposals.
We noted in the proposed rule that we finalized reporting clinical
quality measures for the Medicare EHR Incentive Program by attestation
of clinical quality measure results in the CY 2012 OPPS/ASC final rule
with comment period for FY 2012 and subsequent years, such as FY 2013
(76 FR 74489). Thus, eligible hospitals and CAHs may continue to report
clinical quality measure results as calculated by CEHRT by attestation
for FY 2013, as they did for FYs 2011 and 2012. We also noted the
intent of CMS to move to electronic reporting. In the Medicare and
Medicaid EHR Incentive Programs--Stage 2 final rule, we finalized that
the Medicare EHR Incentive Program would require electronic reporting
of clinical quality measures beginning in FY 2014 for eligible
hospitals and CAHs that are beyond the first year of Stage 1 of
meaningful use (77 FR 54088).
Comment: A few commenters stated that some eCQMs have not been
sufficiently validated. One commenter also stated that not enough
clinical quality measures in the Hospital IQR and Hospital OQR Programs
are electronically specified, noting that some data elements are not
always captured in CEHRT and still require manual review and input. A
few commenters stated that electronic specifications have not undergone
field testing.
Response: The clinical quality measures finalized in the Medicare
and Medicaid EHR Incentive Programs--Stage 2 final rule (77 FR 53968)
for reporting beginning with FY 2014 have either undergone feasibility
testing in EHR systems and clinical settings or were finalized in the
Stage 1 final rule for reporting in FYs 2011 and 2012, and
specifications have been and will continue to be updated based on
experiences with reporting those clinical quality measures in the EHR
Incentive Program.
In addition, the Office of the National Coordinator for Health
Information Technology's (ONC) 2014 Edition EHR certification criteria
explicitly requires that EHR technology presented for certification
must be able to capture the requisite data for each and every clinical
quality measure to which the EHR technology is requested to be
certified (see 45 CFR 170.314(c)(1) and 77 FR 54226 through 54232).
Therefore EHR technology that is certified to the 2014 Edition EHR
certification criteria should include all of the data elements needed
for each and every clinical quality measure to which an EHR technology
is certified for the purposes of the EHR Incentive Program (for a list
of these measures, including other quality measure programs that use
the same measure, please refer to Table 10 of the Medicare and Medicaid
EHR Incentive Programs--Stage 2 final rule at 77 FR 54083 through
54087). Finally, we do not believe that many of the issues experienced
by providers with eCQMs in 2011 and 2012 of the EHR Incentive Program
would continue.
We expect that eCQMs that will be electronically reported in
hospital reporting programs such as the Hospital OQR Program would have
undergone the same or similar processes as the eCQMs in the EHR
Incentive Program (for more information, please refer to the Medicare
and Medicaid EHR Incentive Programs--Stage 2 final rule 77 FR 54053
through 54056, section B.3. Criteria for Selecting CQMs and section
B.4. CQM Specification). As the transition to electronic reporting
becomes more ubiquitous in the hospital reporting programs, we expect
that more eCQMs would be created de novo based on data that is readily
available in EHR systems rather than retooled from paper-based
specifications.
Comment: Several commenters stated that CMS should establish a
process for updating specifications for eCQMs. These commenters also
suggested that we establish a mechanism through which vendors and
providers can offer feedback on problematic or unclear measures.
Response: The Electronic Reporting Pilot, which began in FY 2012
and is being finalized to continue in FY 2013, is used in part as a
mechanism for testing the entire infrastructure for reporting eCQMs,
including the ability to accurately abstract clinical quality data from
EHRs, transmit them to CMS, and for CMS to receive the data. The EHR
Incentive Program is currently the only CMS quality reporting program
using electronic clinical quality measures for hospitals. The process
of updating specifications regularly is expected to continue in order
to maintain alignment with current clinical guidelines and ensure that
the measure remains relevant and actionable within the clinical care
setting.
In addition, we expect to make updates based on experiences of
vendors, providers, and CMS during the process of reporting clinical
quality data. We currently have various forums in which vendors and
providers can provide feedback, such as the joint CMS and the Joint
Commission ePilot vendor conference call, national partners' calls and
open door forums. We continue to engage with the vendor and provider
communities to keep an open dialogue for feedback and continuous
improvement in electronic quality measurement.
Comment: One commenter did not support CMS having direct access to
a facility's EHR for data abstraction.
Response: We have not proposed nor do we intend to directly access
a facility's EHR for data abstraction. The Electronic Reporting Pilot
for the Medicare EHR Incentive Program (established in the CY 2012
OPPS/ASC final rule with comment period and being finalized to continue
in FY 2013 in this final rule with comment period) is expected to be
the basis for electronic reporting of clinical quality data in Hospital
IQR and Hospital OQR Programs, as well as potentially in other hospital
reporting programs.
Comment: Several commenters were concerned about participation
levels in the Electronic Reporting Pilot and suggested flexibility with
data transmission standards, such as using standards that EHR vendors
already use. One commenter urged CMS to perform a comprehensive
assessment of the pilot.
Response: The submission period for the first Electronic Reporting
Pilot (that is, the pilot established for FY 2012) is October 1, 2012
through November 30, 2012. Therefore, when this final rule with comment
period is published, the submission period for the first Electronic
Reporting Pilot for hospitals would not yet be completed and a
comprehensive assessment would not yet be possible. The data
transmission standard used in the Electronic Reporting Pilot (Quality
Reporting Data Architecture category I, or QRDA-I) has also been
finalized in the Medicare and Medicaid EHR Incentive Programs--Stage 2
final rule as a standard that we will accept beginning with FY 2014 (77
FR 54088). ONC has also included QRDA-I in its 2014 Edition EHR
certification criteria, which means that CEHRT should be capable of
transmitting data using this standard if certified to the 2014 Edition
EHR certification criteria. Therefore, it is a standard that we believe
will continue to be used more widely for electronic reporting of
clinical quality measures. As stated previously, we have and will
continue to engage with the vendor community in order to continue to
improve the ease and accuracy of electronic transmission of clinical
quality data.
Comment: One commenter provided suggestions on development and
selection of future electronic clinical
[[Page 68492]]
quality measures, including considerations such as measure validity,
quality improvement potential, reporting burden, and the National
Quality Strategy described in the Medicare and Medicaid EHR Incentive
Programs--Stage 2 final rule (77 FR 54054).
Response: We appreciate the suggestions on development and
selection of future electronic clinical quality measures; however, this
is outside the scope of this rulemaking. We will consider these
suggestions when developing new electronic clinical quality measures
and in future rulemaking when selecting new measures in our quality
reporting programs.
Comment: One commenter stated that it is inconsistent for the
Electronic Reporting Pilot to collect only Medicare data when reporting
of all payer data is instrumental to meeting the goals of national
initiatives as well as needed for Hospital Compare. This commenter was
concerned that submission of patient-level data is inconsistent with
the requirement in the EHR Incentive Program to report summary-level
data and could have adverse consequences for patient privacy.
Response: In order to work towards the goal of transitioning our
quality reporting programs to electronic reporting, we are piloting the
electronic submission of patient-level data, which is the data level
required in the hospital reporting programs, such as the Hospital IQR
and Hospital OQR Programs. Whether the data are submitted to us through
a manual process or electronically, all parties are expected to comply
with HIPAA as applicable in order to maintain patient confidentiality
and secure data transmission. Since this is a pilot, we limited the
data submission to Medicare patients only in order to limit the
reporting burden on participating hospitals during the pilot phase.
Comment: One commenter suggested piloting both the QRDA-I (patient-
level) and QRDA-III (aggregate-level) transmission formats in 2013.
Response: We proposed to continue the Electronic Reporting Pilot
for FY 2013 exactly as adopted for FY 2012, which only included the
QRDA-I transmission format. The QRDA-III format is currently being
finalized and is not ready for full implementation in FY 2013.
Comment: Several commenters supported continuing the Electronic
Reporting Pilot through the EHR Incentive Program. One of these
commenters specifically supported the electronic reporting of clinical
quality measures under the terms in the EHR Incentive Program.
Response: We thank the commenters for the support to continue the
Electronic Reporting Pilot and for electronically-reported clinical
quality measures.
After consideration of the public comments we received, we are
finalizing our proposal to continue the Electronic Reporting Pilot for
FY 2013, as finalized for FY 2012. We are revising our regulations as
proposed at Sec. 495.8(b)(2)(vi) to reflect the continuation of the
Electronic Reporting Pilot for FY 2013 and to remove the reference to
Sec. 495.6(f)(9).
XVI. Requirements for the Ambulatory Surgical Center Quality Reporting
(ASCQR) Program
A. Background
1. Overview
We refer readers to section XV.A.1. of this final rule with comment
period for a general overview of our quality reporting programs.
2. Statutory History of the ASC Quality Reporting (ASCQR) Program
We refer readers to section XIV.K.1. of the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74492 through 74493) for a detailed
discussion of the statutory history of the ASCQR Program.
3. History of the ASCQR Program
In the CY 2008 OPPS/ASC final rule with comment period (72 FR
66875), the CY 2009 OPPS/ASC final rule with comment period (73 FR
68780), the CY 2010 OPPS/ASC final rule with comment period (74 FR
60656), and the CY 2011 OPPS/ASC final rule with comment period (75 FR
72109), we did not implement a quality data reporting program for ASCs.
We determined that it would be more appropriate to allow ASCs to
acquire some experience with the revised ASC payment system, which was
implemented for CY 2008, before implementing new quality reporting
requirements. However, in these rules, we indicated that we intended to
implement a quality reporting program for ASCs in the future.
In preparation for proposing a quality reporting program for ASCs,
in the CY 2011 OPPS/ASC proposed rule (75 FR 46383), we solicited
public comments on 10 measures. In addition to preparing to propose
implementation of a quality reporting program for ASCs, HHS developed a
plan to implement a value-based purchasing (VBP) program for payments
under title XVIII of the Act for ASCs as required by section 3006(f) of
the Affordable Care Act, as added by section 10301(a) of the Affordable
Care Act. We also submitted a report to Congress, as required by
section 3006(f)(4) of the Affordable Care Act, entitled ``Medicare
Ambulatory Surgical Center Value-Based Purchasing Implementation Plan''
that details this plan. This report is found on the CMS Web site at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/Downloads/C_ASC_RTC-2011.pdf. Currently, we do not have
express statutory authority to implement an ASC VBP program. If and
when legislation is enacted that authorizes CMS to implement an ASC VBP
program, we will develop the program and propose its implementation
through notice-and-comment rulemaking.
In the CY 2012 OPPS/ASC final rule with comment period (76 FR 74492
through 74517), we finalized our proposal to implement the ASCQR
Program beginning with the CY 2014 payment determination. We adopted
quality measures for the CY 2014, CY 2015, and CY 2016 payment
determination years and finalized some data collection and reporting
timeframes for these measures. We also adopted policies with respect to
the maintenance of technical specifications and updating of measures,
publication of ASCQR Program data, and, for the CY 2014 payment
determination, data collection and submission requirements for the
claims-based measures. For a discussion of these final policies, we
refer readers to the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74492 through 74517).
In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74515), we indicated our intent to issue proposals for administrative
requirements, data validation and completeness requirements, and
reconsideration and appeals processes in the FY 2013 IPPS/LTCH PPS
proposed rule, rather than in the CY 2013 OPPS/ASC proposed rule,
because the FY 2013 IPPS/LTCH PPS proposed rule was scheduled to be
finalized earlier and prior to data collection for the CY 2014 payment
determination, which is to begin with services furnished on October 1,
2012. In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53636 through
53644), we issued final policies for administrative requirements, data
completeness requirements, extraordinary circumstances waiver or
extension requests, and a reconsideration process. For a complete
discussion of these policies, we refer readers to the FY 2013 IPPS/LTCH
PPS final rule.
Because we included proposals for the ASCQR Program in the FY 2013
[[Page 68493]]
IPPS/LTCH PPS proposed rule, we limited the number of proposals in the
CY 2013 OPPS/ASC proposed rule. In addition, in an effort to prevent
confusion regarding what we proposed in the CY 2013 OPPS/ASC proposed
rule and what we proposed in the FY 2013 IPPS/LTCH PPS proposed rule,
in the CY 2013 OPPS/ASC proposed rule, we limited our discussion of the
proposals contained in the FY 2013 IPPS/LTCH PPS proposed rule
primarily to background related to the proposals in the CY 2013 OPPS/
ASC proposed rule.
Comment: Two commenters supported the implementation of a pay-for-
performance program (that is, an ASC Value-Based Purchasing (VBP)
Program) by CY 2016 to reward high performing facilities and penalize
low performing facilities. The commenters also recommended that the
measure set for such a program focus not only on clinical outcomes and
include clinical process, structural, and patient experience of care
measures, but also minimize burden.
Response: Currently, we do not have the statutory authority to
implement an ASC VBP Program. If legislation is enacted that authorizes
CMS to implement such a program for ASCs, we will consider these
recommendations.
B. ASCQR Program Quality Measures
1. Considerations in the Selection of ASCQR Program Quality Measures
Section 1833(i)(7)(B) of the Act states that section 1833(t)(17)(C)
of the Act shall apply with respect to ASC services in a similar manner
in which they apply to hospitals for the Hospital OQR Program, ``except
as the Secretary may otherwise provide.'' The requirements under
section 1833(t)(17)(C)(i) of the Act state that measures developed
shall ``be appropriate for the measurement of quality of care
(including medication errors) furnished by hospitals in outpatient
settings and that reflect consensus among affected parties and, to the
extent feasible and practicable, shall include measures set forth by
one or more national consensus building entities.''
In addition to following the statutory requirements, in selecting
measures for the ASCQR Program and other quality reporting programs, we
have focused on measures that have a high impact on and support HHS'
and CMS' priorities for improved health care outcomes, quality, safety,
efficiency, and satisfaction for patients. Our goal for the future is
to expand any measure set adopted for the ASCQR Program to address
these priorities more fully and to align ASC quality measure
requirements with those of other reporting programs as appropriate,
including the Hospital OQR Program, so that the burden for reporting
will be reduced.
In general, we prefer to adopt measures that have been endorsed by
the NQF because it is a national multi-stakeholder organization with a
well-documented and rigorous approach to consensus development.
However, as discussed above, the Hospital OQR Program statute only
requires that we adopt measures that are appropriate for the
measurement of the quality of care furnished by hospitals in outpatient
settings, reflect consensus among affected parties, and, to the extent
feasible and practicable, include measures set forth by one or more
national consensus building entities. Therefore, measures are not
required to be endorsed by the NQF or any other national consensus
building entity and, as we have noted in a previous rulemaking for the
Hospital OQR Program (75 FR 72065), the requirement that measures
reflect consensus among affected parties can be achieved in other ways,
including through the measure development process, through broad
acceptance and use of the measure(s), and through public comment.
Further, the Secretary has broader authority under the ASCQR Program
statute, as discussed above, to adopt non-endorsed measures or measures
that do not reflect consensus for the ASCQR Program because, under the
ASCQR Program statute, these Hospital OQR Program provisions apply
``except as the Secretary may otherwise provide.''
In developing the ASCQR Program, we applied the principles set
forth in the CY 2011 OPPS/ASC proposed rule and final rule with comment
period (76 FR 42337 through 42338 and 74494 through 74495,
respectively). Although we did not propose any new measures for the
ASCQR Program in the CY 2013 OPPS/ASC proposed rule as discussed below,
we stated that we plan to apply the following principles in future
measure selection and development for the ASCQR Program. These
principles were applied in developing other quality reporting programs
and many are the same principles applied in developing the ASCQR
Program last year.
Our overarching goal is to support the National Quality
Strategy's goal of better health care for individuals, better health
for populations, and lower costs for health care. The ASCQR Program
will help achieve these goals by creating transparency around the
quality of care provided by ASCs to support patient decision-making and
quality improvement. More information regarding the National Quality
Strategy can be found at: http://www.healthcare.gov/law/resources/reports/quality03212011a.html. HHS engaged a wide range of stakeholders
to develop the National Quality Strategy, as required by the Affordable
Care Act.
Pay-for-reporting and public reporting programs should
rely on a mix of standards, process, outcomes, and patient experience
of care measures. Across all programs, we seek to move as quickly as
possible to the use of primarily outcome and patient experience
measures. To the extent practicable and appropriate, outcome and
patient experience measures should be adjusted for risk or other
appropriate patient population or provider/supplier characteristics.
To the extent possible and recognizing the differences in
payment system maturity and statutory authorities, measures should be
aligned across public reporting and payment systems under Medicare and
Medicaid. The measure sets should evolve so that they include a focused
core set of measures appropriate to the specific provider/supplier
category that reflects the level of care and the most important areas
of service and measures for that provider/supplier.
We weigh the relevance and the utility of measures
compared to the burden on ASCs for submitting data under the ASCQR
Program. The collection of information burden on providers and
suppliers should be minimized to the extent possible. To this end, we
continuously seek to adopt electronic-specified measures so that data
can be calculated and submitted via certified EHR technology with
minimal burden. We also seek to use measures based on alternative
sources of data that do not require chart abstraction or that use data
already being reported by ASCs.
We take into account the views of the Measure Application
Partnership (MAP). The MAP is a public-private partnership convened by
the NQF for the primary purpose of providing input to HHS on selecting
performance measures for quality reporting programs and pay-for-
reporting programs. The MAP views patient safety as a high priority
area and it strongly supports the use of NQF-endorsed safety measures.
Accordingly, we consider the MAP's recommendations in selecting quality
and efficiency measures (we refer readers to the Web sites at: http://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx, and http://
[[Page 68494]]
www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&ItemID=69885).
Measures should be developed with the input of providers/
suppliers, purchasers/payers and other stakeholders. Measures should be
aligned with best practices among other payers and the needs of the end
users of the measures. We take into account widely accepted criteria
established in medical literature.
HHS' Strategic Plan and Initiatives. HHS is the U.S.
Government's principal agency for protecting the health of all
Americans. HHS accomplishes its mission through programs and
initiatives. Every 4 years, HHS updates its Strategic Plan and measures
its progress in addressing specific national problems, needs, or
mission-related challenges. The current goals of the HHS Strategic Plan
can be located on the Web site at: http://www.hhs.gov/secretary/about/priorities/strategicplan2010-2015.pdf.
CMS Strategic Plan. We strive to ensure that measures for
different Medicare and Medicaid programs are aligned with priority
quality goals, that measure specifications are aligned across settings,
that outcome measures are used whenever possible, and that quality
measures are collected from EHRs as appropriate.
We believe that ASCs are similar to HOPDs, insofar as the delivery
of surgical and related nonsurgical services. Similar standards and
guidelines can be applied between HOPDs and ASCs with respect to
surgical care improvement because many of the same surgical procedures
are provided in both settings. Measure harmonization assures that
comparable care in these settings can be evaluated in similar ways,
which further assures that quality measurement can focus more on the
needs of a patient with a particular condition rather than on the
specific program or policy attributes of the setting in which the care
is provided.
We invited public comment on this approach for future measure
selection and development for the ASCQR Program.
Comment: Some commenters supported CMS' efforts to establish the
ASCQR Program. One commenter emphasized that ASCQR Program measures
should reflect ASC facility-level accountability rather than physician-
level accountability.
Response: We appreciate the commenters' support for the
implementation of the ASCQR Program. The measures we adopted for the
ASCQR Program are directly attributable to ASCs. The quality data are
submitted by ASCs and are reported at a facility-level and not at a
physician-level. We finalized a policy to publish ASC quality data by
CMS Certification Number (CCN) in the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74514 through 74515), which is a facility-level
identifier.
Comment: A few commenters asserted that ASCs are small entities and
the utilization of EHR technology in the ASC industry is limited.
Nonetheless, commenters requested that CMS consider electronic
submission as an option for ASCs that have implemented EHR technology.
Response: We recognize that many ASCs are small entities and some
may have limited EHR technology. We are still in the beginning stages
of implementing the ASCQR Program, and we will need to assess the
readiness of ASCs prior to considering an option of allowing electronic
submission of measures for the ASCQR Program.
Comment: One commenter encouraged the adoption of NQF-endorsed
measures to ensure that field testing and the consensus process are
rigorous. Another commenter urged CMS to facilitate direct
representation from the ASC industry on either the National Priorities
Partnership (NPP) or the MAP to formulate priorities for outpatient
settings and coordinate efforts across inpatient and outpatient
settings.
Response: In general, we prefer to adopt measures that have been
endorsed by the NQF because it is a national multi-stakeholder
organization with a well-documented and rigorous approach to consensus
development. However, sections 1833(i)(7)(B) and 1833(t)(17)(C)(i) of
the Act, read together, require that the Secretary develop measures
that the Secretary determines to be appropriate for the measurement of
quality of care (including medication errors) furnished by ASCs and
that reflect consensus among affected parties and, to the extent
feasible and practicable, shall include measures set forth by one or
more national consensus building entities. Therefore, measures are not
required to be endorsed by the NQF or any other national consensus
building entity and, as we have noted in a previous rulemaking (75 FR
72065), the requirement that measures reflect consensus among affected
parties can be achieved in other ways, including through the measure
development process, through broad acceptance and use of the
measure(s), and through public comment. Further, section 1833(i)(7)(B)
of the Act states that these provisions shall apply to the ASCQR
Program ``except as the Secretary may otherwise provide.'' Thus, the
Secretary has broad authority under the ASCQR Program statute to adopt
non-endorsed measures or measures that do not reflect consensus.
As required by section 1890A of the Act, as added by section 3014
of the Affordable Care Act, we submit measures under consideration for
this Program (and other programs utilizing quality measures) to the MAP
by December 1 of each year, at the same time that we make the list of
measures available to the public. We consider the recommendations
issued by the MAP prior to proposing measures for the ASCQR Program.
We encourage stakeholders interested in direct representation on
either the NPP or the MAP to submit nominations to the NQF for
consideration. The NQF holds open calls for membership nominations
annually for both the NPP and the MAP, followed by a public comment
period for vetting of balanced stakeholder groups.
Comment: A few commenters strongly supported CMS' measure selection
criteria for ASCs. Commenters also commended CMS' effort to align some
of the measures for the ASCQR Program with the Hospital OQR Program
measures, and encouraged greater alignment of the measures so that
Medicare beneficiaries can compare ASC and HOPD quality data.
Response: We appreciate the commenters' support for CMS' measure
selection criteria. We believe that ASCs are similar to HOPDs, insofar
as they deliver similar surgical and related nonsurgical services.
Therefore, many of the measures may be applicable across these two
settings. We agree with the commenters that greater harmonization of
measures across these programs would allow beneficiaries to compare
quality of care for similar services across these settings, and we will
seek greater alignment in future program years.
After consideration of the public comments we received, we are
finalizing our approach for future measure selection and development
for the ASCQR Program.
2. ASCQR Program Quality Measures
In the CY 2012 OPPS/ASC final rule with comment period (76 FR 74492
through 74517), we finalized our proposal to implement the ASCQR
Program beginning with the CY 2014 payment determination and adopted
measures for the CY 2014, CY 2015, and CY 2016 payment determinations.
We also finalized our policy to retain measures from one calendar year
payment determination to the next so
[[Page 68495]]
that measures adopted for a previous payment determination year would
be retained for subsequent payment determination years (76 FR 74504,
74509, and 74510).
We adopted the following five claims-based measures for the CY 2014
payment determination for services furnished between October 1, 2012
and December 31, 2012: (1) Patient Burns (NQF 0263); (2)
Patient Fall (NQF 0266); (3) Wrong Site, Wrong Side, Wrong
Patient, Wrong Procedure, Wrong Implant (NQF 0267); (4)
Hospital Transfer/Admission (NQF 0265); and (5) Prophylactic
Intravenous (IV) Antibiotic Timing (NQF 0264).
For the CY 2015 payment determination, we retained the five claims-
based measures we adopted for the CY 2014 payment determination and
adopted the following two structural measures: (1) Safe Surgery
Checklist Use; and (2) ASC Facility Volume Data on Selected ASC
Surgical Procedures. We specified that reporting for the structural
measures would be between July 1, 2013 and August 15, 2013 for services
furnished between January 1, 2012 and December 31, 2012, using an
online measure submission Web page available at: https://
www.QualityNet.org. We did not specify the data collection period for
the five claims-based measures for the CY 2015 payment determination.
For the CY 2016 payment determination, we finalized the retention
of the seven measures from the CY 2015 payment determination (five
claims-based measures and two structural measures) and adopted
Influenza Vaccination Coverage Among Healthcare Personnel (NQF
0431), a process of care, healthcare-associated infection
measure (HAI). We specified that data collection for the influenza
vaccination measure would be via the National Healthcare Safety Network
(NHSN) from October 1, 2014 through March 31, 2015. We did not specify
the data collection period for the claims-based or structural measures.
We stated that, to the extent we finalize some or all of the
measures for future payment determination years, we would not be
precluded from adopting additional measures or changing the list of
measures for future payment determination years through annual
rulemaking cycles so that we may address changes in program needs
arising from new legislation or from changes in HHS' and CMS'
priorities.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45191), considering
the time and effort required for us to develop, align, and implement
the infrastructure necessary to collect data on the ASCQR Program
quality measures and make payment determinations, and likewise the time
and effort required on the part of ASCs to plan and prepare for quality
reporting, we did not propose to delete or add any quality measures for
the ASCQR Program for the CY 2014, CY 2015, and CY 2016 payment
determination years, or to adopt quality measures for subsequent
payment determination years. For readers' reference, the following
table lists the ASCQR Program quality measures that were previously
finalized in the CY 2012 OPPS/ASC final rule with comment period (76 FR
74504 through 74511).
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[GRAPHIC] [TIFF OMITTED] TR15NO12.088
Comment: Many commenters applauded CMS' plan of not adding new
measures to the ASCQR Program at this time because it would allow ASCs
adequate time to adapt to reporting requirements for the initial
measure set for the CY 2014 payment determination.
Response: We appreciate the commenters' support.
3. ASC Measure Topics for Future Consideration
We seek to develop a comprehensive set of quality measures to be
available for widespread use for informed decision-making and quality
improvement in the ASC setting. Therefore, in the CY 2013 OPPS/ASC
proposed rule (77 FR 45191), we stated that, through future rulemaking,
we intend to propose new measures consistent with the principles
discussed in section XVI.B.1. of the proposed rule, in order to select
quality measures that address clinical quality of care, patient safety,
and patient and caregiver experience of care. We invited public comment
specifically on the inclusion of procedure-specific measures for
cataract surgery, colonoscopy, endoscopy, and for anesthesia-related
complications in the ASCQR Program measure set.
Comment: Commenters either supported or suggested the inclusion of
the following measure topics under the ASCQR Program:
Patient Experience of Care
Surgical Site Infection
Surgical Complications
Anesthesia-Related Complications
Otolaryngology
Gastroenterology
Equipment Reprocessing
Adverse Events after Discharge
Response: We appreciate the commenters' suggestions for future
measure topics for the ASCQR Program.
4. Clarification Regarding the Process for Updating ASCQR Program
Quality Measures
In the CY 2012 OPPS/ASC final rule with comment period, we
finalized our proposal to follow the same process for updating the
ASCQR Program measures that we adopted for the Hospital OQR Program's
measures (76 FR 74513 through 74514). This process includes the same
subregulatory process for the ASCQR Program as used for the Hospital
OQR Program for updating measures, including issuing regular manual
releases at 6-month intervals, providing addenda as necessary, and
providing at least 3 months of advance notice for nonsubstantive
changes such as changes to ICD-9-CM, CPT, NUBC, and HCPCS codes, and at
least 6 months' notice for substantive changes to data elements that
would require significant systems changes. We provided a citation to
the CY 2009 OPPS/ASC final rule with comment period where the final
Hospital OQR Program policies are discussed (73 FR 68766 through
68767).
In examining last year's finalized policy for the ASCQR Program, we
recognize that we may need to provide
[[Page 68497]]
additional clarification of the ASCQR Program policy in the context of
the previously finalized Hospital OQR Program policy in the CY 2009
OPPS/ASC final rule with comment period (73 FR 68766 through 68767).
Therefore, in the CY 2013 OPPS/ASC proposed rule (77 FR 45191), we
sought to more clearly articulate the policy that we adopted for the
ASCQR Program, which is the same policy that has been adopted for the
Hospital OQR Program.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68766
through 68767), we established a subregulatory process for making
updates to the measures we have adopted for the Hospital OQR Program.
This process is necessary so that the Hospital OQR measures are
calculated based on the most up-to-date scientific evidence and
consensus standards. Under this process, when a national consensus
building entity updates the specifications for a measure that we have
adopted for the Hospital OQR Program, we update our specifications for
that measure accordingly and provide notice as described above and in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74514). An
example of such an entity is the NQF. For measures that are not
endorsed by a national consensus building entity, the subregulatory
process is based on scientific advances as determined necessary by CMS,
in part, through our measure maintenance process involving Technical
Expert Panels (73 FR 68767). We invited public comment on this
clarification of the finalized ASCQR Program policy of using a
subregulatory process to update measures.
Comment: A few commenters requested that CMS consider the measure
changes made by measure developers and stewards of measures, as these
can occur at any time based on a change in evidence, consensus
standards, or other factors that merit an update. With respect to
measures that are not endorsed by a national entity, the commenters
recommended that CMS consult with ASC clinical and operational experts.
Further, the commenters suggested that the Technical Expert Panels
(TEPs), which are charged with maintenance of the ASCQR Program
measures, include substantial representation from the ASC community and
relevant surgical specialty societies.
Response: We regularly monitor changes to measures adopted for the
ASCQR Program and other quality programs that are made by measure
stewards, as well as the evidence upon which the measures are based.
The current ASCQR Program measure set has been implemented with input
by ASC stakeholders, including the measure stewards, as well as other
affected parties.
For NQF-endorsed measures, measure developers and stewards are
expected to present these changes to the NQF for review annually. We
would incorporate these changes based upon the NQF's acceptance. For
non-NQF-endorsed measures, we evaluate changes to measures recommended
by our contractors' surgical TEP, which includes outpatient ASC
surgical representatives.
In summary, we clarified that we adopted the Hospital OQR Program's
process for updating the ASCQR Program measures that was finalized in
the CY 2009 OPPS/ASC final rule with comment period (73 FR 68766
through 68767), which is explained above.
C. Requirements for Reporting of ASC Quality Data
1. Form, Manner, and Timing for Claims-Based Measures for the CY 2014
Payment Determination and Subsequent Payment Determination Years
a. Background
In the CY 2012 OPPS/ASC final rule with comment period, we adopted
claims-based measures for the CY 2014, CY 2015, and CY 2016 payment
determination years (76 FR 74504 through 74511). We also finalized
that, to be eligible for the full CY 2014 ASC annual payment update, an
ASC must submit complete data on individual quality measures through a
claims-based reporting mechanism by submitting the appropriate QDCs on
the ASC's Medicare claims (76 FR 74515 through 74516). As stated in the
CY 2012 OPPS/ASC final rule with comment period (76 FR 74516), ASCs
will add the appropriate QDCs on their Medicare Part B claims forms,
the Form CMS-1500s submitted for payment, to submit the applicable
quality data. A listing of the QDCs with long and short descriptors is
available in Transmittal 2425, Change Request 7754 released March 16,
2012 (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Transmittals-Items/ASC-CR7754-R2425CP.html). Details on
how to use these codes for submitting numerator and denominator
information are available in the ASCQR Program Specifications Manual
located on the QualityNet Web site (https://www.QualityNet.org). We
also finalized the data collection period for the CY 2014 payment
determination, as the Medicare fee-for-service ASC claims submitted for
services furnished between October 1, 2012 and December 31, 2012. In
the FY 2013 IPPS/LTCH PPS final rule (77 FR 53640), we adopted a policy
that claims for services furnished between October 1, 2012 and December
31, 2012, would have to be paid by the Medicare administrative
contractor (MAC) by April 30, 2013, to be included in the data used for
the CY 2014 payment determination. We believe that this claim paid date
will allow ASCs sufficient time to submit claims while allowing CMS
sufficient time to complete required data analysis and processing to
make payment determinations and to supply this information to
administrative contractors.
b. Form, Manner, and Timing for Claims-Based Measures for the CY 2015
Payment Determination and Subsequent Payment Determination Years
In the CY 2013 OPPS/ASC proposed rule (77 FR 45192) we proposed
that, for the CY 2015 payment determination and subsequent payment
determination years, an ASC must submit complete data on individual
claims-based quality measures through a claims-based reporting
mechanism by submitting the appropriate QDCs on the ASC's Medicare
claims. We proposed that the data collection period for the claims-
based quality measures would be for the calendar year 2 years prior to
a payment determination. We also proposed that the claims for services
furnished in each calendar year would have to be paid by the MAC by
April 30 of the following year of the ending data collection time
period to be included in the data used for the payment determination.
Thus, for example, for the CY 2015 payment determination, we proposed
the data collection period to be claims for services furnished in CY
2013 (January 1, 2013 through December 31, 2013) which are paid by the
MAC by April 30, 2014. We believe that this claim paid date would allow
ASCs sufficient time to submit claims while allowing CMS sufficient
time to complete required data analysis and processing to make payment
determinations and to supply this information to administrative
contractors. We invited public comment on these proposals.
Comment: Some commenters agreed with CMS' proposals to begin the
data collection period for claims-based measures in the calendar year 2
years prior to a payment determination, and to establish the policy
that the claims for services furnished in each calendar year would have
to be paid by the MAC by April 30 of the following year of the ending
data collection time period to be included in the data used for the
[[Page 68498]]
payment determination. The commenters stated that they believed the
April 30 deadline would allow sufficient time for claims processing.
However, other commenters believed the proposed period for the
collection of claims data may be too abbreviated to capture all
pertinent data. Because ASCs have up to 1 year to submit claims for
services furnished, some commenters suggested that the period for the
collection of claims data be as close to 1 year from the date the
service was furnished to be included in a payment determination. Some
commenters suggested that CMS establish a longer time period for the
claims payment deadline in order to include all available claims data
in the data used for payment determinations; one commenter suggested a
June 30 deadline rather than April 30 deadline.
Response: We appreciate the commenters' support of our proposals
regarding the period for the collection of claims data and the time
allowed for data processing to be included in payment determinations.
We agree that sufficient time should be allowed for claims processing
to obtain complete data. We have conducted an internal analysis of
claims submission by ASCs and have found that over 90 percent of the
ASC claims are submitted and paid within the proposed timeframe.
Therefore, we believe at this time that the proposed April 30 claims
paid date is the latest date that would allow CMS to acquire and
analyze the claims data, make payment determinations, and importantly,
provide sufficient time for the MACs to program their systems. However,
as we gain more experience and our systems become established, we will
explore whether allowing more time for claims processing may be
possible; if so, we will propose such changes through notice-and-
comment rulemaking.
Comment: One commenter expressed concern with the lag between the
quality data reporting period and the payment reductions under the
ASCQR Program by basing payment adjustments on participation a full 2
years before the results of a payment determination take effect.
Response: We understand the commenter's concern with the lag
between when data are reported and when payment is affected, and we
will strive to reduce this lag without significant adverse effects on
data completeness and quality. However, we note that with the data
collection period ending December 31 for the payment determinations
becoming effective beginning January 1, the lag basically is 1 year
past the end of the data collection period. Based upon our current
experience, we believe the timeline we are finalizing provides a
balance between data completeness and expediency.
Comment: One commenter stated that the ASCQR Program's use of the
term ``claims-based'' is not consistent with the Hospital IQR Program's
use and does generate additional costs to the organization. The
commenter stated that claims-based measures under the Hospital IQR
Program truly means that CMS can obtain the data solely based on coding
data without the organization taking additional steps of manually
applying quality coding and having a clinician review the record for
inclusion/exclusion criteria. The commenter further stated that for
process measures, it is not accurate to label them as ``claims-based''
and state that this process is not time consuming and costly.
Response: We understand the commenter's concerns. However, we are
clarifying that we have used the term ``claims-based'' to indicate the
data source and mechanism for data submission as well as to
differentiate claims-based measures from measures based on manual
chart-abstracted data. We believe that a claims-based mechanism for
data collection is less time consuming and less costly than such chart-
abstracted quality measures. In addition, the use of the term ``claims-
based'' for the claims-based ASCQR Program quality measures is
consistent with the Physician Quality Reporting Program (PQRS), which
also uses QDCs for the reporting of quality data via claims.
After consideration of the public comments we received, we are
finalizing our proposals without modification that, for the CY 2015
payment determination and subsequent payment determination years, an
ASC must submit complete data on individual claims-based quality
measures through a claims-based reporting mechanism by submitting the
appropriate QDCs on the ASC's Medicare claims. We also are finalizing
that the data collection period for such claims-based quality measures
will be for the calendar year 2 years prior to a payment determination
and that the claims for services furnished in each calendar year will
have to be paid by the MAC by April 30 of the following year of the
ending data collection time period to be included in the data used for
the payment determination.
2. Data Completeness and Minimum Threshold for Claims-Based Measures
Using QDCs
a. Background
In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74516), we finalized our proposal that data completeness for claims-
based measures for the CY 2014 payment determination be determined by
comparing the number of claims meeting measure specifications that
contain the appropriate QDCs with the number of claims that would meet
measure specifications, but did not have the appropriate QDCs on the
submitted claims. In the FY 2013 IPPS/LTCH PPS final rule (77 FR
53641), we finalized our policy for the CY 2014 and CY 2015 payment
determination years that the minimum threshold for successful reporting
be that at least 50 percent of claims meeting measure specifications
contain QDCs. We believe that 50 percent is a reasonable minimum
threshold based upon the considerations discussed above for the initial
implementation years of the ASCQR Program. We stated in that final rule
that we intend to propose to increase this percentage for subsequent
payment determination years as ASCs become more familiar with reporting
requirements for the ASCQR Program.
Comment: One commenter asked what method CMS would use to assess
when to raise the required threshold for the level of completeness.
Response: We plan to monitor the level of completeness for
submitting QDCs and to monitor the ASCQR Program for issues as they
arise. Based upon program experience, we will assess what level of
completeness should be required. Any changes in the threshold level for
completeness of reporting for ASCQR Program claims-based measures will
be proposed through notice-and-comment rulemaking.
b. Data Completeness Requirements for the CY 2015 Payment Determination
and Subsequent Payment Determination Years
After publication of the FY 2013 IPPS/LTCH PPS proposed rule (77 FR
28101 through 28105), we realized that we did not propose a methodology
for determining data completeness for the CY 2015 payment determination
and subsequent payment determination years. Therefore, in the CY 2013
OPPS/ASC proposed rule (77 FR 45192), we proposed that data
completeness for claims-based measures for the CY 2015 payment
determination and subsequent payment determination years be
[[Page 68499]]
determined by comparing the number of Medicare claims (where Medicare
is the primary or secondary payer) meeting measure specifications that
contain the appropriate QDCs with the number of Medicare claims (where
Medicare is the primary or secondary payer) that would meet measure
specifications, but did not have the appropriate QDCs on the submitted
claims for the CY 2015 payment determination and subsequent payment
determination years. We stated that this method is the same method for
determining data completeness for claims-based measures that was
finalized in the CY 2012 OPPS/ASC final rule with comment period for
the CY 2014 payment determination (76 FR 74516).
However, in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53641), we
stated that, because private payers would not have QDCs in their
required HCPCS data files until January 1, 2013, claims with QDCs
received prior to January 1, 2013 could be rejected for invalid codes.
Because it is not possible for ASCs to submit differing codes on
primary versus secondary payer claims for at least some payers, we
specified that only claims where Medicare is the primary payer--not the
secondary payer--will be used in the calculation of data completeness
for the CY 2014 payment determination.
We invited public comment on this proposal.
Comment: One commenter asked how ASCs would be notified of their
claim completeness percentages and encouraged CMS to post claim
completeness percentages on the QualityNet Web site (http://www.QualityNet.org).
Response: We appreciate the commenter's suggestion. We intend to
supply preliminary completeness percentages and other data submission
information to ASCs prior to the closing of the data submission
deadline in April 2013 either electronically or by the mailing of a
facility-specific report so ASCs can assess their data completeness
levels. In addition, ASCs can use their remittance information to
assess if QDCs have been successfully processed by MACs.
We did not receive any public comments regarding our proposal that
data completeness for claims-based quality measures for the CY 2015
payment determination and subsequent payment determination years be
determined by comparing the number of Medicare claims (where Medicare
is the primary or secondary payer) meeting measure specifications that
contain the appropriate QDCs with the number of Medicare claims (where
Medicare is the primary or secondary payer) that would meet measure
specifications, but did not have the appropriate QDCs on the submitted
claims for the CY 2015 payment determination and subsequent payment
determination years. Therefore, we are finalizing this proposal without
modification.
3. Other Comments on the ASCQR Program
Comment: Commenters expressed views and provided suggestions
regarding additional topics and previously finalized policies for which
we did not make proposals in the CY 2013 OPPS/ASC proposed rule,
including comments and suggestions on the following:
The NHSN infrastructure;
Retention of quality measures from one calendar year to
the next;
Case thresholds for determining completeness of reporting;
Alternative methods of data collection for certain
finalized measures;
The utility of certain finalized measures;
Public reporting of data, including previewing data prior
to public display;
Patient exclusions for specific measures;
Data collection and submission time periods for finalized
measures;
Validation;
Mechanisms for opting out of reporting due to lack of
cases meeting measure specifications;
The use of alternatives to claims-based reporting such as
registries and EHRs;
The use of administrative claims data for the
identification of HAIs;
ASCQR Program implementation date; and
Educational outreach to ASCs regarding the ASCQR Program.
Response: We greatly appreciate the commenters' views on these new
topics and our previously finalized policies. Although we did not make
proposals in the CY 2013 OPPS/ASC proposed rule on these topics or
finalized policies, we will consider all of these views for future
rulemaking and program development. For information on the ASCQR
program, we refer readers to the information posted on the QualityNet
Web site (http://www.QualityNet.org) and the CMS Web site (http://www.cms.hhs.gov) under the Quality Initiatives and ASC sections.
D. Payment Reduction for ASCs That Fail To Meet the ASCQR Program
Requirements
1. Statutory Background
Section 1833(i)(2)(D)(iv) of the Act states that the Secretary may
implement the revised ASC payment system ``in a manner so as to provide
for a reduction in any annual update for failure to report on quality
measures in accordance with paragraph (7).'' Paragraph (7) contains
subparagraphs (A) and (B). Subparagraph (A) of paragraph (7) states the
Secretary may provide that an ASC that does not submit ``data required
to be submitted on measures selected under this paragraph with respect
to a year'' to the Secretary in accordance with this paragraph will
incur a 2.0 percentage point reduction to any annual increase provided
under the revised ASC payment system for such year. It also specifies
that this reduction applies only with respect to the year involved and
will not be taken into account in computing any annual increase factor
for a subsequent year. Subparagraph (B) of paragraph (7) makes many of
the provisions of the Hospital OQR Program applicable to the ASCQR
Program ``[e]xcept as the Secretary may otherwise provide.'' Finally,
section 1833(i)(2)(D)(v) of the Act states that, in implementing the
revised ASC payment system for 2011 and each subsequent year, ``any
annual update under such system for the year, after application of
clause (iv) [regarding the reduction in the annual update for failure
to report on quality measures] shall be reduced by the productivity
adjustment described in section 1886(b)(3)(B)(xi)(II).'' Section
1833(i)(2)(D)(v) of the Act also states that the ``application of the
preceding sentence may result in such update being less than 0.0 for a
year, and may result in payment rates under the [revised ASC payment
system] for a year being less than such payment rates for the preceding
year.''
2. Reduction to the ASC Payment Rates for ASCs That Fail To Meet the
ASCQR Program Requirements for the CY 2014 Payment Determination and
Subsequent Payment Determination Years
The national unadjusted payment rates for many services paid under
the ASC payment system equal the product of the ASC conversion factor
and the scaled relative payment weight for the APC to which the service
is assigned. Currently, the ASC conversion factor is equal to the
conversion factor calculated for the previous year updated by the MFP-
adjusted CPI-U update factor,
[[Page 68500]]
which is the adjustment set forth in section 1833(i)(2)(D)(v) of the
Act. The MFP-adjusted CPI-U update factor is the Consumer Price Index
for all urban consumers (CPI-U), which currently is the annual update
for the ASC payment system, minus the MFP adjustment. As discussed in
the CY 2011 MPFS final rule with comment period (75 FR 73397), if the
CPI-U is a negative number, the CPI-U would be held to zero. Under the
ASCQR Program, any annual update would be reduced by 2.0 percentage
points for ASCs that fail to meet the reporting requirements of the
ASCQR Program. This reduction would apply beginning with the CY 2014
payment rates. For a complete discussion of the calculation of the ASC
conversion factor, we refer readers to section XIV.H. of this final
rule with comment period.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45193), in order to
implement the requirement to reduce the annual update for ASCs that
fail to meet the ASCQR Program requirements, we proposed that we would
calculate two conversion factors: a full update conversion factor and
an ASCQR Program reduced update conversion factor. We proposed to
calculate the reduced national unadjusted payment rates using the ASCQR
Program reduced update conversion factor that would apply to ASCs that
fail to meet their quality reporting requirements for that calendar
year payment determination. We proposed that application of the 2.0
percentage point reduction to the annual update may result in the
update to the ASC payment system being less than zero prior to the
application of the MFP adjustment.
The ASC conversion factor is used to calculate the ASC payment rate
for services with the following payment indicators (listed in Addenda
AA and BB to this final rule with comment period, which are available
via the Internet on the CMS Web site): ``A2,'' ``G2,'' ``P2,'' ``R2,''
``Z2,'' as well as the service portion of device-intensive procedures
identified by ``J8.'' We proposed that payment for all services
assigned the payment indicators listed above would be subject to the
reduction of the national unadjusted payment rates for applicable ASCs
using the ASCQR Program reduced update conversion factor.
The conversion factor is not used to calculate the ASC payment
rates for separately payable services that are assigned status
indicators other than payment indicators ``A2,'' ``G2,'' ``J8,''
``P2,'' ``R2,'' and ``Z2.'' These services include separately payable
drugs and biologicals, pass-through devices that are contractor-priced,
brachytherapy sources that are paid based on the OPPS payment rates,
and certain office-based procedures and radiology services where
payment is based on the MPFS PE RVU amount and a few other specific
services that receive cost-based payment. As a result, we also proposed
that the ASC payment rates for these services would not be reduced for
failure to meet the ASCQR Program requirements because the payment
rates for these services are not calculated using the ASC conversion
factor and, therefore, not affected by reductions to the annual update.
Office-based surgical procedures (performed more than 50 percent of
the time in physicians' offices) and separately paid radiology services
(excluding covered ancillary radiology services involving certain
nuclear medicine procedures or involving the use of contrast agents, as
discussed in section XIV.D.2.b. of this final rule with comment period)
are paid at the lesser of the MPFS non-facility PE RVU-based amounts
and the standard ASC ratesetting methodology. We proposed that the
standard ASC ratesetting methodology for this comparison would use the
ASC conversion factor that has been calculated using the full ASC
update adjusted for productivity. This is necessary so that the
resulting ASC payment indicator, based on the comparison, assigned to
an office-based or radiology procedure is consistent for each HCPCS
code regardless of whether payment is based on the full update
conversion factor or the reduced update conversion factor.
For ASCs that receive the reduced ASC payment for failure to meet
the ASCQR Program requirements, we believe that it is both equitable
and appropriate that a reduction in the payment for a service should
result in proportionately reduced copayment liability for
beneficiaries. Therefore, we proposed that the Medicare beneficiary's
national unadjusted copayment for a service to which a reduced national
unadjusted payment rate applies would be based on the reduced national
unadjusted payment rate.
We proposed that all other applicable adjustments to the ASC
national unadjusted payment rates would apply in those cases when the
annual update is reduced for ASCs that fail to meet the requirements of
the ASCQR Program. For example, the following standard adjustments
would apply to the reduced national unadjusted payment rates: the wage
index adjustment, the multiple procedure adjustment, the interrupted
procedure adjustment, and the adjustment for devices furnished with
full or partial credit or without cost. We believe that these
adjustments continue to be equally applicable to payment for ASCs that
do not meet the ASCQR Program requirements.
We invited public comment on these proposals but did not receive
any public comments. Therefore, we are finalizing our proposals without
modification regarding the process for reducing ASC payment rates for
ASCs that fail to meet the ASCQR Program requirements for the CY 2014
payment determination and subsequent payment determination years.
XVII. Inpatient Rehabilitation Facility (IRF) Quality Reporting Program
Updates
A. Overview
In accordance with section 1886(j)(7) of the Act, as added by
section 3004 of the Affordable Care Act, the Secretary established a
quality reporting program (QRP) for Inpatient Rehabilitation Facilities
(IRFs). The IRF Quality Reporting Program (IRF QRP) was implemented in
the FY 2012 IRF PPS final rule (76 FR 47836). We refer readers to the
FY 2012 IRF PPS final rule (76 FR 47873 through 47883) for a detailed
discussion on the background and statutory authority for the IRF QRP.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45193 through 45196),
we proposed to: (1) Adopt updates to a previously adopted measure for
the IRF QRP that will affect the annual prospective payment amounts in
FY 2014; (2) adopt a policy that would provide that any measure that
has been adopted for use in the IRF QRP will remain in effect until the
measure is actively removed, suspended, or replaced; and (3) adopt
policies regarding when rulemaking will be used to update existing IRF
QRP measures.
While we generally would expect to publish IRF QRP proposals in the
annual IRF PPS rule, there are no proposals for substantive changes to
the IRF PPS this year; therefore, we published only an IRF PPS payment
update notice for FY 2013.\2\ Because full notice-and-comment
rulemaking is required for the proposals mentioned above in regard to
the IRF QRP, we needed to identify an appropriate rulemaking vehicle in
which we could insert our IRF QRP proposals. Because the CY 2013 OPPS/
ASC proposed rule was already scheduled to include
[[Page 68501]]
additional pay-for-reporting proposals for the Hospital OQR Program and
quality reporting requirements for the ASCQR Program, it offered an
opportunity to allow the public to review all three quality programs'
proposals in concert with one another in a timeframe that would be
appropriate for implementing the IRF QRP proposals in time for the FY
2014 IRF PPS payment cycle. Therefore, we elected to include the IRF
QRP proposals in the CY 2013 OPPS/ASC proposed rule.
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\2\ The FY 2013 IRF PPS Payment Update Notice was published in
the Federal Register on July 30, 2012 (77 FR 44618). We refer
readers to: http://www.gpo.gov/fdsys/pkg/FR-2012-07-30/pdf/2012-18433.pdf.
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B. Updates to IRF QRP Measures Which Are Made as a Result of Review by
the National Quality Forum (NQF) Process
Section 1886(j)(7) of the Act generally requires the Secretary to
adopt measures that have been endorsed by the entity with a contract
under section 1890(a) of the Act. This contract is currently held by
the National Quality Forum (NQF). The NQF is a voluntary consensus
standard-setting organization with a diverse representation of
consumer, purchaser, provider, academic, clinical, and other health
care stakeholder organizations. The NQF was established to standardize
health care quality measurement and reporting through its consensus
development process.\3\
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\3\ For more information about the NQF Consensus Development
Process, we refer readers to the Web site at: http://www.qualityforum.org/Measuring_Performance/Maintenance_of_NQF-Endorsed%C2%AE_Performance_Measures.aspx).
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The NQF's responsibilities include: (1) Reviewing new quality
measures and national consensus standards for measuring and publicly
reporting on performance; (2) providing annual measure maintenance
updates to be submitted by the measure steward for endorsed quality
measures; (3) providing measure maintenance endorsement on a 3-year
cycle; (4) conducting required follow-up reviews of measures with time-
limited endorsement for consideration of full endorsement; and (5)
conducting ad hoc reviews of endorsed quality measures, practices,
consensus standards, or events when there is adequate justification for
a review.\4\ In the normal course of measure maintenance, the NQF
solicits information from measure stewards for annual reviews and in
order to review measures for continued endorsement in a specific 3-year
cycle. In this measure maintenance process, the measure steward is
responsible for updating and maintaining the currency and relevance of
the measure and for confirming existing specifications to the NQF on an
annual basis.\5\ As part of the ad hoc review process, the ad hoc
review requester and the measure steward are responsible for submitting
evidence to be reviewed by a NQF technical expert panel (TEP) which, in
turn, provides input to the Consensus Standards Approval Committee
(CSAC). This committee then makes a recommendation to the NQF Board on
endorsement status and/or specification changes for the measure,
practice, or event.
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\4\ For more information about the NFQ Ad Hoc Review process, we
refer readers to the Web site at: http://www.qualityforum.org/Projects/ab/Ad_Hoc_Reviews/CMS/Ad_Hoc_Reviews-CMS.aspx).
\5\ For more information about the NQF Measure Maintenance
process, we refer readers to the NQF Web site at: http://www.qualityforum.org/Measuring_Performance/Improving_NQF_Process/Process_Assessment_Measure_Maintenance.aspx.
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Through the NQF's measure maintenance process, the NQF-endorsed
measures are sometimes updated to incorporate changes that we believe
do not substantially change the nature of the measure. Examples of such
changes that we gave in the CY 2013 OPPS/ASC proposed rule (77 FR
45194) included updated diagnosis or procedure codes, changes to
exclusions to the patient population, definitions, or extension of the
measure's endorsement to apply to other settings. We stated in the
proposed rule that we believed these types of maintenance changes are
distinct from more substantive changes to measures that result in what
can be considered new or different measures, and that they do not
trigger the same agency obligations under the Administrative Procedure
Act.
In the CY 2013 OPPS/ASC proposed rule, we proposed that if the NQF
updates an endorsed measure that we have adopted for the IRF QRP in a
manner that we consider to not substantially change the nature of the
measure, we would use a subregulatory process to incorporate those
updates to the measure specifications that apply to the program.
Specifically, we would revise the information that is posted on the CMS
IRF QRP Web site at: http://www.cms.gov/IRF-Quality-Reporting/ so that
it clearly identifies the updates and provides links to where
additional information on the updates can be found. In addition, we
would refer IRFs to the NQF Web site for the most up-to-date
information about the quality measures (http://www.qualityforum.org/ org/).
We would provide sufficient lead time for IRFs to implement the changes
where changes to the data collection systems would be necessary.
We proposed to continue to use the rulemaking process to adopt
changes to measures that we consider to substantially change the nature
of the measure. We believe that our proposal adequately balances our
need to incorporate NQF updates to NQF-endorsed IRF QRP measures in the
most expeditious manner possible, while preserving the public's ability
to comment on updates to measures that so fundamentally change an
endorsed measure that it is no longer the same measure that we
originally adopted. We noted that, in the FY 2013 IPPS/LTCH PPS
proposed rule, we proposed a similar policy for the Long-Term Care
Hospital Quality Reporting (LTCHQR) Program (77 FR 53652 through
53653). CMS finalized a modified version of this policy for the LTCHQR
Program, as discussed below.
Comment: Many of the commenters supported the use of the
subregulatory process to incorporate NQF updates to measures that do
not substantially change the nature of the measure. One commenter
believed that this approach would be reasonable, as long as the use of
the subregulatory process does not create any additional burden for
IRFs. Another commenter stated that not all NQF updates need to be
subject to a formal rulemaking process before the update can be
implemented.
Response: We appreciate the commenters' support of our proposal.
However, in response to some of the concerns expressed by other
commenters below, and to be consistent with the policy that we have
adopted for other quality reporting programs, we are finalizing this
proposal with the modifications discussed below.
Comment: Several commenters supported the proposal to use the
subregulatory process to incorporate non-substantial NQF updates to
quality measures that are made between rulemaking cycles. However, the
commenters expressed concern regarding how CMS would define substantial
and non-substantial changes. The commenters were concerned that even
slight changes to a measure's specifications will cause them to incur
significant burden. The commenters urged CMS to use great caution in
making decisions about what should be classified as a substantial
change and a non-substantial change. One commenter expressed concern
regarding the lack of specificity in the definition of a substantial
change to a measure. One commenter suggested that the decision on
whether a change to a measure rises to the level of substantial should
be made by giving consideration not only to the measure itself, but
also to what data the provider is required to report on the changed
measure and how it would impact providers. Another commenter expressed
concern that there was a lack of specificity by both CMS and the NQF
regarding the definition of
[[Page 68502]]
a substantive change in a measure. Several commenters disagreed with
the examples of substantial and non-substantial changes to a measure
that were presented in the CY 2013 OPPS/ASC proposed rule. Another
commenter urged CMS to consider any update to a measure that requires
any additional data collection as a substantial change and thus subject
to the more formal rulemaking process.
Response: The NQF regularly maintains its endorsed measures through
annual and triennial reviews, which may result in the NQF making
updates to the NQF-endorsed measures. We believe that it is important
to have a subregulatory process in place, which we can use to
incorporate non-substantive changes made by the NQF to measures we have
adopted for use in the IRF QRP. Such a policy would allow for IRF QRP
measures to be updated quickly and with a minimum amount of burden to
IRF providers. However, we do recognize that some changes the NQF might
make to its endorsed measures are substantive in nature and, therefore,
it might not be appropriate for CMS to adopt these changes to the
measures used in the IRF QRP using a subregulatory process.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45194), we proposed a
policy to use a subregulatory process to adopt changes made to quality
measures by the NQF that we consider to be non-substantial in nature.
We further proposed to continue using the rulemaking process to adopt
changes made by the NQF if we consider them to substantially change the
nature of a measure. We have recently reconsidered these proposals in
light of modified policies that were finalized in other quality
reporting programs, such as the LTCHQR Program and the Hospital IQR
Program. We have also reconsidered our proposals regarding this policy
in light of the public comments we received. We believe that
consistency and harmonization among the Medicare quality reporting
programs is vitally important and helps to reduce provider burden.
In the FY 2013 IPPS/LTCH final rule (77 FR 53504) we indicated
examples of what we might generally regard as non-substantive changes
to measures might include, but are not limited to, updated diagnosis or
procedure codes, medication updates for categories of medications, or a
broadening of age ranges. We believe that non-substantive changes may
also include updates to NQF-endorsed measures based upon changes to
guidelines upon which the measures are based. We noted that the NQF
process has already incorporated an opportunity for public comment and
engagement in the measure maintenance process.
We stated that we will continue to use rulemaking to adopt
substantive updates made by the NQF to the endorsed measures we have
adopted for the IRF Quality Reporting Program. Examples of changes that
we might generally consider to be substantive would include, but are
not limited to, those circumstances in which the changes are so
significant that the measure is no longer the same measure, or when a
standard of performance assessed by a measure becomes more stringent
(for example, changes in acceptable timing of medication, NQF expansion
of endorsement of a previously endorsed measure to a new setting,
procedure/process, or test administration). However, these and other
changes would need to be evaluated on a case-by-case basis to determine
whether or not a change to a measure is in fact substantive. We intend
to follow this modified policy when making changes to all IRF QRP
measures.
Comment: One commenter recommended that CMS clearly identify
subregulatory updates, provide links to where additional information
about the updates can be found, and provide sufficient lead time for
IRFs to implement any changes related to the NQF's updates. Another
commenter recommended that CMS confer with a sufficient number of
stakeholders in the rehabilitation hospital community to apprise them
of the impending change and to seek informal feedback and input prior
to adopting the measure's change. Further, the commenter recommended
that CMS conduct testing of the change to determine its effectiveness
before implementation.
Response: In the event that any measure that has been previously
adopted for use in the IRF QRP is updated in a manner that we deem to
be non-substantive in nature, we will use the subregulatory process to
incorporate those changes. We will ensure that stakeholders are fully
informed about these changes and that they have been afforded adequate
lead time to make any necessary changes. Some of the methods that we
will use to keep our stakeholders informed include: posting of
information on the IRF QRP Web page \6\; holding special open door
forums, posting information in the CMS weekly E-News publication, and
responding to provider questions that we receive through the IRF QRP
helpdesk.\7\ While we expect to provide notice to stakeholders when we
intend to seek NQF's review of measures, the NQF process incorporates
an opportunity for public comment and engagement in the measure
maintenance process.\8\
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\6\ http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/index.html?redirect=/IRF-Quality-Reporting/.
\7\ [email protected].
\8\ For information about the NQF consensus development process,
we refer readers to the NQF Web site at: http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process%e2%80%99s_Principle/Public_and_Member_Comment.aspx.
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After consideration of the public comments we received, we are
adopting as final a policy to: (a) Utilize a subregulatory process to
incorporate updates to the IRF QRP quality measures that are not
substantive in nature; and (b) continue use of the rulemaking process
to adopt changes to measures that we consider to be substantive in
nature.
C. Process for Retention of IRF Quality Measures Adopted in Previous
Fiscal Year Rulemaking Cycles
We expect that the measures that we adopt for purposes of the IRF
QRP will remain current and useful for a number of years after their
initial adoption. While we could elect to adopt measures for each
fiscal year's payment determinations, we believe that it would be
easier for all parties concerned if we adopt the measures in perpetuity
with an expectation that we will propose to remove, suspend or replace
measures through future rulemaking, if necessary. Therefore, for the
purpose of streamlining the rulemaking process, in the CY 2013 OPPS/ASC
proposed rule (77 FR 45194), we proposed that when we initially adopt a
measure for the IRF QRP for a payment determination, that measure will
be automatically adopted for all subsequent fiscal year's payment
determinations or until such time as we might propose and finalize the
measure's removal, suspension, or replacement.
Quality measures may be considered for removal by CMS if: (1)
Measure performance among IRFs is so high and unvarying that meaningful
distinctions in improvements in performance can no longer be made; (2)
performance or improvement on a measure does not result in better
patient outcomes; (3) a measure does not align with current clinical
guidelines or practice; (4) a more broadly applicable measure (across
settings, populations, or conditions) for the particular topic is
available; (5) a measure that is more proximal in time to desired
patient outcomes for the particular topic is
[[Page 68503]]
available; (6) a measure that is more strongly associated with desired
patient outcomes for the particular topic becomes available; or (7)
collection or public reporting of a measure leads to negative
unintended consequences.
For any such removal, the public will be given an opportunity to
comment through the next annual rulemaking process. However, if there
is reason to believe that continued data collection of a measure raises
potential safety concerns, we will take immediate action to remove the
measure from the IRF QRP and not wait for the annual rulemaking cycle.
Such measures will be promptly removed with IRFs and the public being
immediately notified of such a decision through the usual IRF QRP
communication channels, including listening sessions, memos, email
notifications, and Web site postings. In such instances, the immediate
removal of a measure will also be formally confirmed in the next annual
rulemaking cycle. We invited public comment on our proposal that once a
quality measure is adopted, it is retained for use in the subsequent
fiscal year's payment determinations unless otherwise stated.
Comment: One commenter suggested that CMS should be required to re-
propose quality measures each year so that stakeholders have the
opportunity to submit comments before measures are finalized for use.
The commenter stated that there needs to be a continuing opportunity
for the public to comment each year on not only measures that are being
proposed, but also on measures that were previously adopted. Further,
the commenter expressed concern that this policy would result in a
scenario in which stakeholder comments about previously adopted
measures would not be given proper consideration.
Response: Our proposal to retain previously finalized IRF QRP
measures for future years aligns with our policy to retain measures for
future years in other Medicare quality reporting programs such as the
LTCHQR Program and the Hospital IQR Program. We plan to review quality
measures that have been adopted for use in the IRF QRP on at least an
annual basis to make sure that each measure remains relevant, valid and
reliable. The optimum time to perform this review would be at the time
when we review and analyze the quality measure data received from IRFs
for any given reporting period or data reporting cycle. Some of the IRF
QRP measures may be reviewed more often, depending upon the frequency
with which we receive data for these measures or whether other
circumstances prompt review. We will perform ad hoc reviews of IRF QRP
quality measures if we find any indication that a measure is no longer
valid, reliable or that continued collection of data for this measure
leads to negative unintended consequences. Regardless of the type of
review performed, if our analysis of these data reveals that a quality
measure meets any of the above-stated enumerated criteria for removal
(for reasons other than patient safety) we will propose to remove that
measure in the next rulemaking cycle. If, at any time, we discover that
an IRF quality measure poses a potential safety concern, we will take
immediate action to remove that measure from the IRF QRP.
We have provided IRFs with a mechanism by which to submit comments
regarding quality measures that have previously been adopted for use in
the IRF QRP. IRFs may submit comments regarding quality measures that
are already being used in the IRF QRP through the IRF QRP helpdesk
email box.\9\ We will give full consideration to any comments that we
receive.
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\9\ [email protected].
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Finally, we also plan to solicit input in regard to the quality
measures that are already being used in the IRF QRP from technical
experts, as well as the public, through venues such as listening
sessions, special open door forums, and national provider calls. These
venues will provide IRFs with several ways to provide us with input on
quality measures that are currently in use under the IRF QRP. We will
give equal consideration to comments that we receive in regard to
measures, whether they are being proposed or have previously been
finalized for use under the IRF QRP. This will help to ensure that each
of the adopted measures remains appropriate for continued inclusion in
the IRF QRP.
After consideration of the public comments we received, we are
finalizing our proposal to retain adopted quality measures for
subsequent reporting periods (and the associated annual payment
determinations) unless we propose to remove, suspend, or replace these
measures.
We proposed to apply this principle to the two measures that were
selected for use in the IRF QRP beginning on October 1, 2012. These
adopted measures are: (1)) An application of the NHSN Catheter-
Associated Urinary Tract Infection (CAUTI) Outcome measure (NQF
0138),\10\ and (2) An application of the Percent of Residents
with Pressure Ulcers that Are New or Worsened measure (NQF
0678). We also invited public comment on our proposal to apply
the principle of retention to the two above-stated quality measures
that were adopted for use under the IRF QRP in the FY 2012 IRF PPS
final rule (76 FR 47874 through 47878) for the second and all
subsequent reporting periods (and associated payment determinations).
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\10\ The CAUTI measure that was adopted in the FY 2012 IRF PPS
final rule (76 FR 47836 through 47915) was titled ``Urinary
Catheter-Associated Urinary Tract Infection [CAUTI] Rate Per 1,000
Urinary Catheter Days for ICU patients.'' However, this measure was
submitted by the CDC (measure steward) to the NQF for a measure
maintenance review. As part of their NQF submission, the CDC asked
for changes to the measure, including expansion of the scope of the
measure to non-ICU settings, including IRFs. The NQF approved the
CDC's request on January 12, 2012. Due to the changes that were made
to the measure, the CDC believed that it was appropriate that the
measure title be changed. This measure is now titled ``National
Health Safety Network (NHSN) Catheter Associated Urinary Tract
Infection (CAUTI) Outcome Measure.''
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Likewise, we invited public comment on our proposed use of the
process, as stated above, for retention of any additional future
quality measures that may be adopted for use in the IRF QRP.
Comment: Two commenters supported CMS' proposal for retention of
the two quality measures that were previously finalized for use under
the IRF QRP.
Response: We appreciate the commenters' support of our proposed
approach for retention of the two quality measures adopted for use
under the IRF QRP.
After consideration of the public comments we received, for the
reasons set forth above, we are finalizing our proposal to apply this
policy of retention of IRF QRP quality measures to the two measures
that were finalized in the FY 2012 IRF PPS final rule. These measures
are (1) An application of the NHSN Catheter-Associated Urinary Tract
Infection (CAUTI) Outcome Measure (NQF 0138) (previously
titled ``CAUTI rate per 1,000 urinary catheter days, for Intensive Care
Unit Patients''); and (2) An application of the Percent of Residents
with Pressure Ulcers that Are New or Worsened measure (NQF
0678).\11\ Although we are retaining these measures for the
IRF QRP, we discuss below certain updates that we are making with
respect to each of them.
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\11\ This measure was recently reviewed by the NQF and the scope
of the measure was expanded to include post-acute care settings such
as IRFs. Patients in post-acute care settings are referred to as
``patients'' as opposed to ``residents'', which is a term used in
the nursing home setting. To reflect the expansion in the scope of
this measure, the title was changed to ``Percent of Patients/
Residents with Pressure Ulcers that Are New or Worsened (NQF
0678)'' (emphasis added).
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[[Page 68504]]
D. Measures for the FY 2014 Payment Determination
We have previously identified the measurement of pressure ulcers
and the prevalence of urinary tract infections (UTI) as two critical
areas for quality measurement under the IRF QRP. While section
1886(j)(7) of the Act generally requires the adoption of endorsed
measures, there were no NQF-endorsed measures for the two desired areas
in the IRF context at the time CMS was conducting its rulemaking. As
section 1886(j)(7)(D)(ii) of the Act authorizes the use of measures
that are not endorsed when there are no feasible and practicable
endorsed options, in the FY 2012 IRF PPS final rule (76 FR 47874
through 47878), we adopted applications of an NQF-endorsed pressure
ulcer measure that had been endorsed for use in skilled nursing
facilities (NQF 0678) and a CDC measure, the CDC's Urinary
Catheter Associated Urinary Tract Infection [CAUTI] rate per 1, 000
urinary catheter days, for Intensive Care Unit [ICU] Patients (NQF
0138), that had NQF endorsement for use in intensive care
settings of hospitals.
1. Clarification Regarding Existing IRF Quality Measures That Have
Undergone Changes During NQF Measure Maintenance Processes
In the FY 2012 IRF PPS final rule (76 FR 47874 through 47876), we
used the endorsement exception authority under section
1886(j)(7)(D)(ii) of the Act. This authority permitted us to adopt the
Urinary Catheter-Associated Urinary Tract Infection [CAUTI] rate per
1,000 urinary catheter days, for Intensive Care Unit [ICU] Patients
measure (NQF 0138). We chose to adopt this measure because
there was no NQF-endorsed CAUTI measure available to assess the
prevalence of urinary CAUTI rates in the IRF setting.
As stated in section XVII.C. of this final rule with comment
period, the CAUTI measure steward, the CDC, submitted the CAUTI measure
to the NQF for a scheduled measure maintenance review in late 2011. At
that time, the CDC also filed a request to expand the CAUTI measure to
non-ICU settings, including IRFs. The NQF granted the CDC's request for
an expansion of the scope of endorsement of the CAUTI measure to
additional non-ICU care settings, including ``rehabilitation
hospitals.'' The NQF defined the term ``rehabilitation hospitals'' as
including both freestanding IRFs, as well as IRF units that are located
within an acute care facility. Despite the expansion in the scope of
endorsement of the CAUTI measure, the original NQF endorsement number
(NQF 0138) was retained. However, the measure was re-titled
``National Health Safety Network (NHSN) Catheter Associated Urinary
Tract Infection (CAUTI) Outcome Measure.'' \12\
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\12\ http://www.qualityforum.org/MeasureDetails.aspx?actid=0&SubmissionId=1121#k=0138&e=0&st=&sd=&s=n&so=a&p=1&mt=&cs=&ss=.
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As amended, the expanded CAUTI measure includes a different data
calculation method, which is referred to as the standardized infection
ratio (SIR).\13\ The change in the data calculation method does not,
however, change the way in which IRFs will submit CAUTI data to the
CDC. IRFs will still be required to submit their CAUTI data to the CDC
via the National Healthcare Safety Network (NHSN) online system.
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\13\ Centers for Disease Control and Prevention (2012, January),
Catheter Associated Urinary Tract Infection Event. Retrieved from:
http://www.cdc.gov/nhsn/PDFs/pscManual/7pscCAUTIcurrent.pdf.
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Under the originally endorsed version of the CAUTI measure, the CDC
calculated an infection rate per 1,000 urinary catheter days. Under the
new method, CDC will use a SIR calculation method, which is comprised
of the observed number of infections over the expected number of
infections.\14\ The SIR calculation consists of an ``observed'' rate of
CAUTI infections over the ``expected rate'' of CAUTI infections for
that particular healthcare location. The CDC calculates the ``expected
rate'' of CAUTI infections from CAUTI data that is reported to them by
healthcare facilities. According to the epidemiologists at the CDC,
they will need to analyze approximately 12 months of CAUTI data in
order to calculate the ``expected rate'' of CAUTI infections for any
given healthcare facility.
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\14\ http://www.cdc.gov/nhsn/pdfs/pscmanual/
7psccauticurrent.pdf.
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We believe that the SIR calculation method is a more accurate way
to calculate the CAUTI measure results for comparative purposes because
it takes into account an IRF's case mix. In addition, use of the SIR
calculation does not require any change to the type of data required to
be submitted by IRFs or the method of data submission that IRFs must
use in order to comply with the CAUTI measure reporting requirements.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45196), we made the
following proposals in regards to the CAUTI measure: (1) We proposed to
adopt the changes made to the NQF 0138 CAUTI measure, which
will apply to the FY 2014 annual payment update determination; (2) we
proposed to adopt the CAUTI measure, as revised by the NQF on January
12, 2012, for the FY 2015 payment determination and all subsequent
fiscal year's payment determinations; and (3) we proposed to
incorporate, for use under the IRF QRP, any future changes to the CAUTI
measure to the extent these changes are consistent with our proposal in
section XVII.B. of the CY 2013 OPPS/ASC proposed rule to update
measures.
Comment: Several commenters supported our proposal to adopt the
changes made by the NQF to the CAUTI measure. Several commenters also
supported use of the SIR calculation. The commenters also supported the
delay in the implementation of the SIR calculation by the CDC. One
commenter agreed that CMS should delay public reporting of the CAUTI
measure data until after the CDC has collected enough data to calculate
the expected CAUTI infection rate that will be used in the SIR
calculations.
Response: We agree that use of the SIR calculation will be a more
accurate method for risk stratified calculation of the CAUTI measure
data. We also agree that public reporting of the CAUTI measure data
should not take place until sufficient baseline data has been collected
by the CDC.
Comment: One commenter expressed concern regarding CMS being able
to properly risk adjust the CAUTI data results using the SIR
calculation. The commenter was concerned that IRFs caring for more
complicated patients will appear to have worse quality outcomes than
other IRFs that care for less specialized patients, unless CMS can make
the proper type of risk adjustments. The commenter further expressed
concern that the SIR calculation method will be unable to provide
adequate risk adjustment when comparing IRFs that have a specialized
patient population to other IRFs that tend to have a more general
patient population.
Response: After the IRF QRP begins, the CDC will take time to
collect and analyze the CAUTI measure data in an amount that is
sufficient to calculate an ``expected rate'' of CAUTI infection for IRF
locations/units. The CDC needs up to 12 months of CAUTI data from
various IRF's in order to calculate the ``expected'' CAUTI rates for
the IRFs locations and units. These expected CAUTI infection rates can
then be used to calculate a SIR for each IRF that includes adjustment
for the patient population mix. The CDC and their subject matter
experts, will make a determination with regard to how the
[[Page 68505]]
patient population mix will be used in the risk adjustment for the SIR.
Comment: One commenter expressed concern regarding IRFs being held
accountable for CAUTI infections that a patient acquired prior to an
admission or transfer into that IRF.
Response: To help determine where the CAUTI infection may have
developed, the CAUTI measure specifications incorporate a ``transfer
rule.'' The ``transfer rule'' provides that if a patient develops a
CAUTI within 48 hours of transfer from another location, the CAUTI is
attributed back to the transferring location (http://www.cdc.gov/nhsn/
pdfs/pscmanual/7psccauticurrent.pdf). We believe that the use of the
transfer rule to the CAUTI measure calculations will help ensure that
CAUTI infections are properly attributed to the facility where they
originated.
Comment: One commenter suggested that pediatric patients should be
excluded from the CAUTI measure because it has not been NQF-endorsed
for the pediatric population due to low frequency of catheter use and
difficulty in attributing UTIs.
Response: We disagree with the commenter's suggestion that
pediatric patients should be excluded from this measure for the reasons
stated below. The measure specifications for the NQF 0138
CAUTI measure exclude patients in a neonatal ICU, but otherwise have no
other age based exclusions. The target population age range for the NQF
0138 CAUTI measure is described in the measure specifications
as follows: ``Patients of all ages are eligible except patients in
Levels I, II, II/III and III nurseries, and in locations where patients
do not reside overnight.'' (Emphasis added)
Second, we believe that it is important to gather and analyze CAUTI
measure data from patients of all age groups so that we can study the
rate of CAUTI infections in not only adults and the elderly, but also
in children. There are several IRFs that specialize in the
rehabilitation of pediatric patients. Many other IRFs also treat
pediatric patients. We would be remiss in our duty to measure the
quality of care in the IRF setting if we did not gather CAUTI measure
data from these IRFs on their pediatric patients.
After consideration of the public comments we received, we are
finalizing our proposals to: (1) Adopt the changes made to the NHSN
Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure
(NQF 0138) as applicable to the FY 2014 annual payment update
determination; and (2) adopt the NHSN Catheter-Associated Urinary Tract
Infection (CAUTI) Outcome Measure (NQF 0138) measure for the
FY 2015 payment determination and all subsequent fiscal year payment
determinations thereafter.
2. Updates to the ``Percent of Residents Who Have Pressure Ulcers That
Are New or Worsened'' Measure
In the FY 2012 IRF PPS final rule (76 FR 47876 through 47878), we
again used the endorsement exception authority under section
1886(j)(7)(D)(ii) of the Act to adopt an application of the ``Percent
of Residents with Pressure Ulcers that Are New or Worsened'' measure
(NQF 0678). We selected this measure because there was no
other NQF-endorsed measure available to assess the percentage of
patients with pressure ulcers that are new or worsened in the IRF
setting at that time. We recognized that the NQF endorsement of this
measure was, at that time, limited to short-stay nursing home patients,
but we noted our belief that this measure was highly relevant to
patients in any setting who are at risk of pressure ulcer development
and a high priority quality issue in the care of IRF patients.
Therefore, in the FY 2012 IRF PPS final rule, we finalized the adoption
of an application of the NQF-endorsed 0678 pressure ulcer
measure. We also stated that we would request that the NQF extend its
endorsement of this short-stay nursing home pressure ulcer measure to
the IRF setting (76 FR 47876 through 47878).
In April 2012, CMS filed an ad hoc request for review of the NQF
0678 short-stay pressure ulcer measure with the NQF. As part
of that request, we asked the NQF to expand its endorsement of the
measure to several other care settings, including IRFs. As we noted in
the FY 2012 IRF PPS final rule, we believe this measure is highly
applicable to all post acute care settings, including IRFs (76 FR
47876). We stated in the proposed rule that if the pressure ulcer
measure was revised by the NQF, we anticipated that it would be re-
titled ``Percent of Patients or Residents with Pressure Ulcers That Are
New or Worsened'' (NQF 0678) (emphasis added) so as to reflect
the expansion in the scope of the applicable patient population.
In the CY 2013 OPPS/ASC proposed rule (77 FR 45196), we noted that,
as of the publication of that proposed rule, the NQF review process for
the NQF 0678 pressure ulcer measure expansion request was
still in progress. We proposed that if the NQF expands the scope of
endorsement for this measure to the IRF setting, without any
substantive changes, we would adopt and use the NQF-endorsed pressure
ulcer measure in the IRF QRP, in accordance with the policy set forth
above in section XVII.B. of that proposed rule. We believed that, in
this anticipated scenario, the pressure ulcer measure, as revised,
would be substantively the same measure, although broader in scope,
than the current NQF-endorsed