81 FR 50793 - Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 148 (August 2, 2016)
Page Range
50793-51040
FR Document
2016-17733
This proposed rule proposes to implement three new Medicare Parts A and B episode payment models under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. We believe this model will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures. This proposed rule also includes several proposed modifications to the Comprehensive Care for Joint Replacement model.
Federal Register, Volume 81 Issue 148 (Tuesday, August 2, 2016)
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Proposed Rules]
[Pages 50793-51040]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-17733]
[[Page 50793]]
Vol. 81
Tuesday,
No. 148
August 2, 2016
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 510 and 512
Medicare Program; Advancing Care Coordination Through Episode Payment
Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and
Changes to the Comprehensive Care for Joint Replacement Model (CJR);
Proposed Rule
Federal Register / Vol. 81 , No. 148 / Tuesday, August 2, 2016 /
Proposed Rules
[[Page 50794]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 510 and 512
[CMS-5519-P]
RIN 0938-AS90
Medicare Program; Advancing Care Coordination Through Episode
Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model;
and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule proposes to implement three new Medicare
Parts A and B episode payment models under section 1115A of the Social
Security Act. Acute care hospitals in certain selected geographic areas
will participate in retrospective episode payment models targeting care
for Medicare fee-for-service beneficiaries receiving services during
acute myocardial infarction, coronary artery bypass graft, and surgical
hip/femur fracture treatment episodes. All related care within 90 days
of hospital discharge will be included in the episode of care. We
believe this model will further our goals of improving the efficiency
and quality of care for Medicare beneficiaries receiving care for these
common clinical conditions and procedures. This proposed rule also
includes several proposed modifications to the Comprehensive Care for
Joint Replacement model.
DATES: Comment period: To be assured consideration, comments on this
proposed rule must be received at one of the addresses provided in the
ADDRESSES section no later than 5 p.m. EDT on October 3, 2016.
ADDRESSES: In commenting, please refer to file code CMS-5519-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
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-5519-P, 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 to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-5519-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
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,
call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For questions related to the proposed EPMs: [email protected].
For questions related to the CJR model: [email protected].
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
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.thefederalregister.org/fdsys/.
Alphabetical List of Acronyms
Because of the many terms to which we refer by acronym,
abbreviation, or short form in this proposed rule, we are listing the
acronyms, abbreviations and short forms used and their corresponding
terms in alphabetical order.
ACE Acute-care episode
ACO Accountable Care Organization
ALOS Average length of stay
AMA American Medical Association
AMI Acute Myocardial Infarction
APM Alternative Payment Model
ASC QRP Ambulatory Surgical Center Quality Reporting Program
ASC Ambulatory Surgical Center
ASPE Assistant Secretary for Planning and Evaluation
BPCI Bundled Payments for Care Improvement
CABG Coronary Artery Bypass Graft
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CC Complication or comorbidity
CCDA Consolidated clinical document architecture
CCDE Core clinical data elements
CCN CMS Certification Number
CEC Comprehensive ESRD Care Initiative
CEHRT Certified Electronic Health Record Technology
CFR Code of Federal Regulations
CJR Comprehensive Care for Joint Replacement
CMHC Community Mental Health Center
[[Page 50795]]
CMI Case Mix Index
CMMI Center for Medicare and Medicaid Innovation
CMP Civil monetary penalty
CMS Centers for Medicare & Medicaid Services
CoP Condition of Participation
CPC Comprehensive Primary Care Initiative
CPT Current Procedural Terminology
CR Cardiac rehabilitation
CSA Combined Statistical Area
CVICU Cardiovascular intensive care units
CY Calendar year
DME Durable medical equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies
DSH Disproportionate Share Hospital
ECQM Electronic Clinical Quality Measures
EFT Electronic funds transfer
EHR Electronic health record
E/M Evaluation and management
EPM Episode payment model
ESCO ESRD Seamless Care Organization
ESRD End-Stage Renal Disease
FFS Fee-for-service
GAAP Generally-Accepted Accounting Principles
GEM General Equivalence Mapping
GPCI Geographic Practice Cost Index
HAC Hospital-Acquired Condition
HACRP Hospital-Acquired Condition Reduction Program
HCAHPS Hospital Consumer Assessment of Healthcare Providers and Systems
HCC Hierarchical Condition Category
HCPCS Healthcare Common Procedure Coding System
HHA Home health agency
HHPPS Home Health Prospective Payment System
HHRG Home Health Resource Group
HHS U.S. Department of Health and Human Services
HH QRP Home Health Quality Reporting Program
HICN Health Insurance Claim Number
HIPPA Health Insurance Portability and Accountability Act
HIQR Hospital Inpatient Quality Reporting
Health IT Health Information Technology
HLMR HCAHPS Linear Mean Roll Up
HOOS Hip Dysfunction and Osteoarthritis Outcome Score
HOPD Hospital outpatient department
HRRP Hospital Readmissions Reductions Program
HRR Hospital Referral Region
HVBP Hospital Value-Based Purchasing Program
HIV Human Immunodeficiency Virus
ICD-9-CM International Classification of Diseases, 9th Revision,
Clinical Modification
IRFQRICD-10-CM International Classification of Diseases, 10th Revision,
Clinical Modification
ICR Intensive Cardiac Rehabilitation
IME Indirect medical education
IPPS Inpatient Prospective Payment System
IPF Inpatient psychiatric facility
IRF QRP Inpatient Rehabilitation Facility Quality Reporting Program
IPF QRP Inpatient Psychiatric Facility Quality Reporting Program
IRF Inpatient rehabilitation facility
KOOS Knee Injury and Osteoarthritis Outcome Score
LEJR Lower-extremity joint replacement
LIP Low-income percentage
LOS Length-of-stay
LTCH QRP Long-Term Care Hospital Quality Reporting Program
LTCH Long-term care hospital
LUPA Low-utilization payment adjustment
MAC Medicare Administrative Contractor
MACRA Medicare Access and CHIP Reauthorization Act of 2015
MAPCP Multi-Payer Advanced Primary Care Practice
MAT Measure Authoring Tool
MCC Major complications or comorbidities
MCCM Medicare Care Choices Model
MDC Major diagnostic category
MDH Medicare-Dependent Hospital
MedPAC Medicare Payment Advisory Commission
MIPS Merit-based Incentive Payment System
MP Malpractice
MSA Metropolitan Statistical Area
MS-DRG Medical Severity Diagnosis-Related Group
NPI National Provider Identifier
NPRA Net Payment Reconciliation Amount
NQF National Quality Forum
OCM Oncology Care Model
OIG Department of Health and Human Services' Office of the Inspector
General
OPPS Outpatient Prospective Payment System
OQR Outpatient Quality Reporting
PBPM Per-beneficiary per-month
PCI Percutaneous Coronary Intervention
PCMH Primary Care Medical Homes
PE Practice Expense
PFS Physician Fee Schedule
PGP Physician group practice
PQRS Physician Quality Reporting System
PHA Partial hip arthroplasty
PPS Prospective Payment System
PRO Patient-Reported Outcome
PROMIS Patient-Reported Outcomes Measurement Information Systems
PRO-PM Patient-Reported Outcome Performance Measure
PTCA Percutaneous transluminal coronary angioplasty
PY Performance year
QIO Quality Improvement Organization
RAC Recovery Audit Contractor
RRC Rural Referral Center
RSCR Risk-Standardized Complication Rate
RSRR Risk-Standardized Readmission Rate
RSMR Risk-Standardized Mortality Rate
RVU Relative Value Unit
SCH Sole Community Hospital
SHFFT Surgical hip/femur fracture treatment
SILS2 Single Item Health Literacy Screening
SNF QRP Skilled Nursing Facility Quality Reporting Program
SNF Skilled nursing facility
THA Total hip arthroplasty
TIN Taxpayer identification number
TKA Total knee arthroplasty
TP Target price
UHDDS Uniform Hospital Discharge Data Set
VR-12 Veterans Rand 12 Item Health Survey
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
1. Model Overview--EPM episodes of care
2. Model Scope
3. Payment
4. Similar, Previous, and Concurrent Models
5. Overlap with Ongoing CMS Efforts
6. Quality Measures and Reporting Requirements
7. Beneficiary Protections
8. Financial Arrangements
9. Data Sharing
10. Program Waivers
C. Summary of Economic Effects
II. Background
III. Provisions of the Proposed Regulations
A. Selection of Episodes for Episode Payment Models in this
Rulemaking and Potential Future Directions
1. Selection of Episodes for Episode Payment Models in this
Rulemaking
a. Overview
b. SHFFT Model
c. AMI and CABG Models
2. Advanced Alternative Payment Model Considerations
a. Overview for the EPMs
b. EPM Participant Tracks
c. Clinician Financial Arrangements Lists under the EPMs
d. Documentation Requirements
3. Future Directions for Episode Payment Models
a. Refinements to the BPCI Initiative Models
b. Potential Future Condition-Specific Episode Payment Models
[[Page 50796]]
c. Potential Future Event-Based Episode Payment Models for
Procedures and Medical Conditions
d. Health Information Technology Readiness for Potential Future
Episode Payment Models
B. Proposed Definition of the Episode Initiator and Selected
Geographic Areas
1. Background
2. Proposed definition of episode initiator
3. Financial responsibility for episode of care
4. Proposed Geographic Unit of Selection and Exclusion of
Selected Hospitals
5. Overview and Options for Geographic Area Selection for AMI
and CABG Episodes
a. Exclusion of Certain MSAs
b. Proposed Selection Approach
(1) Factors Considered but Not Used
(2) Sample Size Calculations and the Number of Selected MSAs
(3) Method of Selecting MSAs
C. Episode Definition for EPMs
1. Background
2. Overview of Proposed Three New Episode Payment Models
3. Clinical Dimensions of AMI, CABG, and SHFFT Model Episodes
a. Definition of the Clinical Conditions Included in AMI, CABG,
and SHFFT Model Episodes
(1) AMI (Medical Management and PCI) Model
(2) CABG Model
(3) SHFFT (Excludes Lower Extremity Joint Replacement) Model
b. Definition of the Related Services Included in EPM Episodes
4. EPM Episodes
a. Beneficiary Care Inclusion Criteria and Beginning of EPM
Episodes
(1) General Beneficiary Care Inclusion Criteria
(2) Beginning AMI Model Episodes
(3) Beginning CABG Model Episodes
(4) Beginning SHFFT Episodes
(5) Special Policies for Hospital Transfers of Beneficiaries
with AMI
b. Middle of EPM Episodes
c. End of EPM Episodes
(1) AMI and CABG Models
(2) SHFFT Model
D. Methodology for Setting EPM Episode Prices and Paying EPM
Participants in the AMI, CABG, and SHFFT Models
1. Background
a. Overview
b. Key Terms for EPM Episode Pricing and Payment
2. Performance Years, Retrospective Episode Payments, and Two-
Sided Risk EPMs
a. Performance Period
b. Retrospective Payment Methodology
c. Two-Sided Risk EPMs
3. Adjustments to Actual EPM Episode Payments and to Historical
Episode Payments used to Set Episode Prices
a. Overview
b. Special Payment Provisions
c. Services that Straddle Episodes
d. High-Payment EPM Episodes
e. Treatment of Reconciliation Payments and Medicare Repayments
when Calculating Historical EPM-Episode Payments to Update EPM
Benchmark and Quality-Adjusted Target Prices
4. EPM-Episode Price-Setting Methodologies
a. Overview
(1) AMI model
(2) CABG model
(3) SHFFT model
b. EPM-Episode Benchmark and Quality-Adjusted Target Price
Features
(1) Risk-Stratifying EPM-Episode Benchmark Prices based on MS-
DRG and Diagnosis
(2) Adjustments to Account for EPM-Episode Price Variation
(a) Adjustments for Certain AMI Model Episodes with Chained
Anchor Hospitalizations
(b) Adjustments for CABG Model Episodes
(c) Adjustments for Certain AMI Model Episodes with CABG
Readmissions
(d) Potential Future Approaches to setting Target Prices for AMI
and Hip Fracture Episodes
(e) Summary of Pricing Methodologies for AMI, CABG, and SHFFT
Model Episode Scenarios
(3) 3 Years of Historical Data
(4) Trending Historical Data to the Most Recent Year
(5) Update Historical EPM-Episode Payments for Ongoing Payment
System Updates
(6) Blend Hospital-Specific and Regional Historical Data
(7) Define Regions as U.S. Census Divisions
(8) Normalize for Provider-Specific Wage Adjustment Variations
(9) Combining Episodes to Set Stable Benchmark and Quality-
Adjusted Target Prices
(10) Effective Discount Factors
c. Approach to Combine Pricing Features for all SHFFT Model
Episodes and AMI Model Episodes without CABG readmissions
d. Approach to Combine Pricing Features for CABG Model Episodes
(1) Anchor Hospitalization Portion of CABG Model Episodes
(2) Approach to Combine Pricing Features for Post-Anchor
Hospitalization Portion of CABG Model Episodes
(3) Combine CABG Anchor Hospitalization Benchmark Price and CABG
Post-Anchor Hospitalization Benchmark Price
e. Approach to Combine Pricing Features for AMI Model episodes
with CABG Readmissions
5. Process for Reconciliation
a. Net Payment Reconciliation Amount (NPRA)
b. Payment Reconciliation
c. Reconciliation Report
6. Adjustments for Overlaps with Other Innovation Center Models
and CMS Programs
a. Overview
b. Provider Overlap
(1) BPCI Participant Hospitals in Geographic Areas Selected for
EPMs
(2) BPCI Physician Group Practice (PGP) Episode Initiators in
Hospitals Participating in EPMs
c. Beneficiary Overlap
(1) Beneficiary Overlap with BPCI
(2) Beneficiary Overlap with the CJR Model and other EPMs
(3) Beneficiary Overlap with Shared Savings Models and Programs
d. Payment Reconciliation of Overlap with non-ACO CMS Models and
Programs
7. Limits or Adjustments to EPM Participants' Financial
Responsibility
a. Overview
b. Limit on Actual EPM-Episode Payment Contribution to Repayment
Amounts and Reconciliation Payments
(1) Limit on Actual EPM-Episode Payment Contribution to
Repayment Amounts
(2) Limitation on Reconciliation Payments
c. Additional Protections for Certain EPM Participants
(1) Proposed Policies for Certain EPM Participants to Further
Limit Repayment Responsibility
(2) Considerations for Hospitals Serving a High Percentage of
Potentially Vulnerable Populations
d. Application of Stop-Gain and Stop-Loss Limits
e. EPM Participant Responsibility for Increased Post-Episode
Payments
8. Appeals Process
a. Overview
b. Notice of calculation error (first level appeal)
c. Dispute Resolution Process (second level of appeal)
d. Exception to the Notice of Calculation Error Process and
Notice of Termination
e. Limitations on review
E. EPM quality measures, public display, and use of quality
measures in the EPM payment methodology
1. Background
2. Selection of Proposed Quality Measures for the EPMs
a. Overview of Quality Measure Selection
b. AMI Model Quality Measures
c. CABG Model Quality Measures
d. SHFFT Model Quality Measures
3. Proposed Use of Quality Measures in the EPM Payment
Methodologies
a. Overview of EPM Composite Quality Score Methodology
b. Determining Quality Measure Performance
c. Determining Quality Measure Improvement
d. Determining Successful Submission of Voluntary Data for AMI
and SHFFT Models
(1) Hybrid AMI Mortality (NQF #2473) Voluntary Data
(2) Patient-Reported Outcomes and Limited Risk Variable
Voluntary Data Following Elective Primary THA/TKA
e. Calculation of the EPM-Specific Composite Quality Score
(1) AMI Model Composite Quality Score
(2) CABG Model Composite Quality Score
(3) SHFFT Model Composite Quality Score
f. EPM Pay-for-Performance Methodologies to Link Quality and
Payment
(1) Overview of Pay-for-Performance Proposals Applicable to the
EPMs
(2) AMI and CABG Model Pay-for-Performance Methodology
(a) AMI Model Pay-for-Performance Methodology
(b) CABG Model Pay-for-Performance Methodology
[[Page 50797]]
(c) Interface Considerations for the AMI and CABG Model
Methodologies
(3) SHFFT Model Pay-for-Performance Methodology
4. Details on Quality Measures for the EPMs
a. AMI Model-Specific Measures
(1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate
Following Acute Myocardial Infarction (AMI) Hospitalization (NQF
#0230) (MORT-30-AMI)
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Risk-Adjustment
(f) Calculating the Risk-Standardized Mortality Ratio (RSMR) and
Performance Period
(2) Excess Days in Acute Care after Hospitalization for Acute
Myocardial Infarction (AMI Excess Days)
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Risk-Adjustment
(f) Calculating the Rate and Performance Period
(3) Hybrid Hospital 30-Day, All-Cause, Risk-Standardized
Mortality Rate Following Acute Myocardial Infarction (AMI)
Hospitalization (NQF# 2473)(Hybrid AMI Mortality)
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Risk-Adjustment
(f) Calculating the Risk-Standardized Mortality Ratio (RSMR) and
Performance Period
(g) Requirements for Successful Submission of AMI Voluntary Data
b. CABG Model-Specific Measure
(1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate
(RSMR) Following Coronary Artery Bypass Graft (CABG) Surgery (NQF#
2558)(MORT-30-CABG)
(a) Background
(b) Data Source
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Risk-Adjustment
(f) Calculating the Risk-Standardized Mortality Ratio (RSMR) and
Performance Period
c. SHFFT Model-Specific Measures
(1) Hospital Level Risk Standardized Complication Rate (RSCR)
Following Elective Primary Total Hip Arthroplasty (THA) and/or Total
Knee Arthroplasty (TKA) (NQF #1550) (Hip/Knee Complications)
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Risk Adjustment
(f) Calculating the Risk Standardized Complication Rate and
Performance Period
(2) Hospital-Level Performance Measure(s) of Patient-Reported
Outcomes Following Elective Primary Total Hip and/or Total Knee
Arthroplasty
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Outcome
(f) Risk Adjustment (if applicable)
(g) Calculating the Risk Standardized Rate
(h) Requirements for Successful Submission of THA/TKA Patient-
Reported Outcome-Based Voluntary Data
d. Measure Used for All EPMs
(1) Hospital Consumer Assessment of Healthcare Providers and
Systems (HCAHPS) Survey (NQF #0166)
(a) Background
(b) Data Sources
(c) Cohort
(d) Inclusion and Exclusion Criteria
(e) Case-Mix Adjustment
(f) HCAHPS Scoring
(g) Calculating the Rate and Performance Period
e. Potential Future Measures
5. Form, Manner, and Timing of Quality Measure Data Submission
6. Display of Quality Measures and Availability of Information
for the Public from the AMI, CABG, and SHFFT Models
F. Compliance Enforcement and Termination of an Episode Payment
Model
1. Overview and Background
2. Proposed Compliance Enforcement for EPMs
3. Proposed Termination of an Episode Payment Model
G. Monitoring and Beneficiary Protection
1. Introduction and Summary
2. Beneficiary Choice
3. Beneficiary Notification
4. Monitoring for Access to Care
5. Monitoring for Quality of Care
6. Monitoring for Delayed Care
H. Access to Records and Record Retention
I. Financial Arrangements under EPM
1. Background
2. Overview of the EPM Financial Arrangements
3. EPM Collaborators
4. Sharing Arrangements under EPM
a. General
b. Requirements
c. Gainsharing Payment, Alignment Payment, and Internal Cost
Savings Conditions and Restrictions
d. Documentation Requirements
5. Distribution Arrangements under the EPM
a. General
b. Requirements
6. Downstream Distribution Arrangements under the EPM
a. General
b. Requirements
7. Summary of Proposals for Sharing, Distribution, and
Downstream Distribution Arrangements under the EPM
8. Enforcement Authority
9. Beneficiary Engagement Incentives under the EPM
a. General
b. Technology Provided to an EPM Beneficiary
c. Clinical Goals of the EPM
d. Documentation of Beneficiary Incentives
10. Compliance with Fraud and Abuse Laws
J. Proposed Waivers of Medicare Program Requirements
1. Overview
2. Summary of Waivers Adopted Under the CJR Model
3. Analysis of Current Model Data
a. Analysis of Waiver Usage
b. Analysis of Discharge Destination--Post-Acute Care Usage
c. Analysis of Hospital Mean Length of Stay Data
4. Post-Discharge Home Visits
a. AMI Model
b. CABG Model
c. SHFFT Model
5. Billing and Payment for Telehealth Services
6. SNF 3-Day Rule
a. Waiver of SNF 3-Day Rule
b. Additional Beneficiary Protections under the SNF 3-Day Stay
Rule Waiver
7. Waivers of Medicare Program Rules to Allow Reconciliation
Payment or Repayment Actions Resulting from the Net Payment
Reconciliation Amount
8. New Waiver for Providers and Suppliers of Cardiac
Rehabilitation and Intensive Cardiac Rehabilitation Services
Furnished to EPM Beneficiaries During an AMI or CABG Episode
K. Data Sharing
1. Overview
2. Beneficiary Claims Data
3. Aggregate Regional Data
4. Timing and Period of Baseline Data
5. Frequency and Period of Claims Data Updates for Sharing
Beneficiary-Identifiable Claims Data During the Performance Period
6. Legal Permission to Share Beneficiary-Identifiable Data
7. Data Considerations with Respect to EPM and CJR Collaborators
L. Coordination with other agencies
IV. Evaluation Approach
A. Background
B. Design and Evaluation Methods
C. Data Collection Methods
D. Key Evaluation Research Questions
E. Evaluation Period and Anticipated Reports
V. Comprehensive Care for Joint Replacement Model
A. Participant Hospitals in the CJR Model
B. Inclusion of Reconciliation and Repayment Amounts when
Updating Data for Target Prices
C. Quality-Adjusted Target Price
D. Reconciliation
1. Hospital Responsibility for Increased Post-Episode Payments
2. ACO Overlap and Subsequent Reconciliation Calculation
3. Stop-Loss and Stop-Gain Limits
4. Proposed Modifications to Reconciliation Process
E. Use of Quality Measures and the Composite Quality Score
1. Hospitals Included in Quality Performance Distribution
2. Quality Improvement Points
3 Relationship of composite quality score to quality categories
[[Page 50798]]
4. Maximum Composite Quality Score
5e. Acknowledgement of Voluntary Data Submission
6. Calculation of the HCAHPS Linear Mean Roll-up (HLMR) Score
F. Accounting for Overlap with CMS ACO Models and the Medicare
Shared Savings Program
G. Appeals Process
H. Beneficiary Notification
1. Physician and PGP Provision of Notice
2. Other CJR collaborators provision of notice
3. Beneficiary Notification Compliance and Records
4. Compliance with Sec. 510.110
I. Compliance Enforcement
1. Failure to comply.
J. Financial Arrangements under the CJR model
1. Definitions related to Financial Arrangements
a. Addition to the definition of CJR collaborators
b. Deleting the term collaborator agreements
c. Addition of CJR activities
2. Sharing arrangements
a. General
b. Requirements
c. Gainsharing Payment, Alignment Payment, and Internal Cost
Savings Conditions and Restrictions.
d. Documentation
3. Distribution arrangements
a. General
b. Requirements
4. Downstream Distribution Arrangements under the CJR model
a. General
b. Requirements
5. Summary of Proposals for Sharing, Distribution, and
Downstream Distribution
K. Beneficiary Incentives under the CJR model
L. Access to Records and Record Retention
M. Waivers of Medicare Program Rules to Allow Reconciliation
Payment or Repayment Actions Resulting From the Net Payment
Reconciliation Amount
N. SNF 3-day Waiver Beneficiary Protections
O. Advanced Alternative Payment Model Requirements
1. Overview for CJR
2. CJR Participant Hospital Track
3. Clinician Financial Arrangements Lists under the CJR Model
4. Documentation Requirements
VI. Cardiac Rehabilitation Incentive Payment Model
A. Background
B. Overview of the CR Incentive Payment Model
1. Rationale for the CR Incentive Payment Model
2. General Design of the CR Incentive Payment Model
C. CR Incentive Payment Model Participants
D. CR/ICR Services that Count Towards CR Incentive Payments
E. Determination of CR Incentive Payments
1. Determination of CR Amounts that Sum to Determine a CR
Incentive Payment
2. Relation of CR Incentive Payments to EPM Pricing and Payment
Policies and Sharing Arrangements for EPM-CR participants
3. CR Incentive Payment Report
4. Proposed Timing for Making CR Incentive Payments
F. Provisions for FFS-CR Participants
1. Access to Records and Retention for FFS-CR participants
2. Appeals Process for FFS-CR Participants
a. Overview
b. Notice of Calculation Error (first level appeal).
c. Dispute Resolution Process (second level of appeal)
d. Exception to the Notice of Calculation Error Process and
Notice of Termination.
e. Limitations on review.
3. Data Sharing for FFS-CR Participants
a. Overview
b. Data Sharing with CR participants
4. Compliance Enforcement for FFS-CR Participants and
Termination of the CR Incentive Payment Model
5. Enforcement Authority for FFS-CR Participants
6. Beneficiary Engagement Incentives for FFS-CR Participants
7. Waiver of Physician Definition for Providers and Suppliers of
CR/ICR Services Furnished to FFS-CR Beneficiaries During an AMI Care
Period or CABG Care Period
a. Overview of Program Rule Waivers Under an EPM
b. General Physician Requirements for Furnishing CR/ICR Services
c. Proposed Waiver of Physician Definition For Providers and
Suppliers of CR/ICR Services Furnished to EPM Beneficiaries During
AMI or CABG Model Episodes
d. Proposed Waiver of Physician Definition For Providers or
Suppliers of CR/ICR Services Furnished to FFS-CR Beneficiaries
During AMI Care Periods or CABG Care Periods
G. Considerations Regarding Financial Arrangements Under the CR
Incentive Payment Model
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Regulatory Impact Analysis
A. Statement of Need
1. Need for EPM Proposed Rule
2. Need for CJR Modifications
3. Need for CR Incentive Payment Model
4. Aggregate Impact of EPMs, CJR, and CR Incentive Payment Model
B. Overall Impact
C. Anticipated Effects
1. Overall Magnitude of the Model and its Effects on the Market
a. EPMs
b. CJR
c. CR Incentive Payment Model
d. Aggregate Effects on the Market
2. Effects on the Medicare Program
a. EPMs
(1) Assumptions
(2) Analyses
(3) Uncertainties
b. CJR
(1) Assumptions and Uncertainties
(2) Analyses
c. CR Incentive Payment Model
(1) Assumptions and Uncertainties
(2) Analysis
3. Effects on Beneficiaries
4. Effects on Small Rural Hospitals
5. Effects on Small Entities
6. Effects on Collection of Information
7. Unfunded Mandates
D. Alternatives Considered
E. Accounting Statement and Table
F. Conclusion
Regulations Text
I. Executive Summary
A. Purpose
The purpose of this proposed rule--Advancing Care Coordination
through Episode Payment Models, is to propose the creation and testing
of three new episode payment models (EPMs) and a Cardiac Rehabilitation
(CR) incentive payment model under the authority of the Center for
Medicare and Medicaid Innovation (CMMI or ``the Innovation Center'').
Section 1115A of the Social Security Act (``the Act'') authorizes the
Innovation Center to test innovative payment and service-delivery
models to reduce Medicare, Medicaid, and Children's Health Insurance
Program expenditures while preserving or enhancing the quality of care
furnished to such programs' beneficiaries. Under the fee-for-service
(FFS) program, Medicare makes separate payments to providers and
suppliers for the items and services furnished to a beneficiary over
the course of treatment (an episode of care). With the amount of
payments dependent on the volume of services delivered, providers may
not have incentives to invest in quality-improvement and care-
coordination activities. As a result, care may be fragmented,
unnecessary, or duplicative. The goal for the proposed EPMs is to
improve the quality of care provided to beneficiaries in an applicable
episode while reducing episode spending through financial
accountability.\1\ The proposed EPMs would include models for episodes
of care surrounding an acute myocardial infarction (AMI), coronary
artery bypass graft (CABG), and surgical hip/femur fracture treatment
excluding lower extremity joint replacement (SHFFT). Under the proposed
rule, the Centers for Medicare & Medicaid Services (CMS) will test
whether an EPM for AMI, CABG, and SHFFT episodes of care will reduce
Medicare expenditures while preserving or enhancing the quality of care
for Medicare beneficiaries. We anticipate the proposed models would
benefit Medicare beneficiaries by improving the
[[Page 50799]]
coordination and transition of care, improving the coordination of
items and services paid for through FFS Medicare, encouraging more
provider investment in infrastructure and redesigned care processes for
higher-quality and more efficient service delivery, and incentivizing
higher-value care across the inpatient and post-acute care spectrum. We
propose to test the proposed EPMs for 5 performance years, beginning
July 1, 2017, and ending December 31, 2021.
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\1\ In this proposed rule, we use the terms ``AMI episode,''
``CABG episode,'' and ``SHFFT episode'' to refer to episodes of care
as described in section III.C. of this proposed rule.
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Within this proposed rule, we propose three distinct EPMs focused
on episodes of care for AMI, CABG, and SHFFT episodes. We chose these
episodes for the proposed models because, as discussed in depth in
section III.A. of this proposed rule, we believe hospitals would have
significant opportunity to redesign care and improve quality of care
furnished during the applicable episode. In addition, significant
variation in spending occurs during these high-expenditure, common
episodes. The proposed EPMs would enable hospitals to consider the most
appropriate strategies for care redesign, including: (1) increasing
post-hospitalization follow-up and medical management for patients; (2)
coordinating across the inpatient and post-acute care spectrum; (3)
conducting appropriate discharge planning; (4) improving adherence to
treatment or drug regimens; (5) reducing readmissions and complications
during the post-discharge period; (6) managing chronic diseases and
conditions that may be related to the proposed EPMs' episodes; (7)
choosing the most appropriate post-acute care setting; and (8)
coordinating between providers and suppliers such as hospitals,
physicians, and post-acute care providers. The proposed EPMs would
offer hospitals the opportunity to examine and better understand their
own care processes and patterns with regard to patients in AMI, CABG,
and SHFFT episodes, as well as the processes of post-acute care
providers and physicians.
We previously have used our statutory authority under section 1115A
of the Act to test other episode payment models such as the Bundled
Payments for Care Improvement (BPCI) initiative and Comprehensive Care
for Joint Replacement (CJR) model. Bundled payments for multiple
services in an episode of care hold participating organizations
financially accountable for that episode of care. Such models also
allow participants to receive payments based in part on the reduction
in Medicare expenditures that arise from such participants' care
redesign efforts. This payment can be used for investments in care
redesign strategies and infrastructure, as well as to incentivize
collaboration with other providers and suppliers furnishing services to
beneficiaries included in the models.
We believe the proposed EPMs would further the Innovation Center's
mission and the Administration's goal of increasingly paying for value
and outcomes, rather than for volume alone,\2\ by promoting the
alignment of financial and other incentives for all health care
providers caring for beneficiaries during SHFFT, CABG, or AMI episodes.
The acute care hospital where an eligible beneficiary has an initial
hospitalization for one of the procedures or clinical conditions
included in these proposed EPMs would be held accountable for spending
during the episode of care. EPM participants could earn reconciliation
payments by appropriately reducing expenditures and meeting certain
quality metrics. EPM participants also would gain access to data and
educational resources to better understand care patterns during the
inpatient hospitalization and post-acute periods, as well as associated
spending. Payment approaches that reward providers for assuming
financial and performance accountability for a particular episode of
care create incentives for the implementation and coordination of care
redesign between participants and other providers and suppliers such as
physicians and post-acute care providers.
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\2\ Episodes for AMI, CABG, and SHFFT beneficiaries initiated by
all U.S. IPPS hospitals not in Maryland and constructed using
standardized Medicare FFS Parts A and B claims, as proposed in this
rule that end in CY 2014.
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The proposal for the AMI, CABG, and SHFFT models would require the
participation of hospitals in multiple geographic areas that might not
otherwise participate in testing episode payment for the proposed
episodes of care. CMS is testing other episode payment models with the
BPCI initiative and the CJR model. The BPCI initiative is voluntary;
providers applied to participate and chose from 48 clinical episodes.
BPCI participants entered the at-risk phase between 2013 and 2015 and
have the option to continue participating in the initiative through FY
2018. In the CJR model, acute care hospitals in selected geographic
areas are required to participate in the CJR model for all eligible
lower-extremity joint replacement (LEJR) episodes that initiate at a
CJR participant hospital. The CJR model began its first of 5
performance years on April 1, 2016. Realizing the full potential of new
EPMs will require the engagement of an even broader set of providers
than have participated to date in our episode payment models such as
the BPCI initiative and the CJR model. As such, we are interested in
testing and evaluating the impact of episode payment for the three
proposed EPMs in a variety of circumstances, including those hospitals
that may not otherwise participate in such a test.
While we note that testing of the CJR model that began in April
2016 will allow CMS to gain experience with requiring hospitals to
participate in an episode payment model, the clinical circumstances of
the episodes we are proposing (AMI, CABG, and SHFFT) differ in
important ways from the LEJR episodes included in the CJR model. LEJR
procedures are common among the Medicare population, and the majority
of such procedures are elective. In contrast, under the three proposed
EPMs, CMS would test episode payment for certain cardiac conditions and
procedures, as well as SHFFT. We expect the patient population included
in these episodes would be substantially different from the patient
population in CJR episodes, due to the clinical nature of the cardiac
and SHFFT episodes. Beneficiaries in these episodes commonly have
chronic conditions that contribute to the initiation of the episodes,
and need both planned and unplanned care throughout the EPM episode
following discharge from the initial hospitalization that begins the
episode. Both AMI and CABG model episodes primarily include
beneficiaries with cardiovascular disease, a chronic condition which
likely contributed to the acute events or procedures that initiate the
episodes. About half the average AMI model historical episode spending
was for the initial hospitalization, with the majority of spending
following discharge from the initial hospitalization due to hospital
readmissions, while there was relatively less spending on SNF services,
Part B professional services, and hospital outpatient services. In CABG
model historical episodes, about three-quarters of episode spending was
for the initial hospitalization, with the remaining episode spending
relatively evenly divided between Part B professional services and
hospital readmissions, and a lesser percentage on SNF services. Similar
to AMI episodes, post-acute care provider use was relatively uncommon
in CABG model historical episodes, while hospital readmissions during
CABG model historical episodes were relatively common. SHFFT model
historical episodes also were accompanied by substantial spending
[[Page 50800]]
for hospital readmissions, and post-acute care provider use in these
episodes also was high. The number of affected beneficiaries and
potential impact of the models on quality and Medicare spending present
an important opportunity to further the Administration's goal of
shifting health care payments to support the quality of care over the
quantity of services by promoting better coordination among health care
providers and suppliers and greater efficiency in the care of
beneficiaries in these models, while reducing Medicare expenditures.\3\
Pay-for-performance episode payment models such as the three EPMs
proposed in this rulemaking financially incentivize improved quality of
care and reduced cost by aligning the financial incentives of all
providers and suppliers caring for model beneficiaries with these
goals. This alignment leads to a heightened focus on care coordination
and management throughout the episode that prioritizes the provision of
those items and services which improve beneficiary outcomes and
experience at the lowest cost. A more detailed discussion of the
evidence supporting the episode selection for these models can be found
in section III.A.1. of the proposed rule.
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\3\ Sylvia Mathews Burwell, HHS Secretary, Progress Towards
Achieving Better Care, Smarter Spending, Healthier People, http://www.hhs.gov/blog/2015/01/26/progress-towards-better-care-msarter-spending-healthier-people.html (January 26, 2015).
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The proposed models would also allow CMS to gain additional
experience with episode-payment approaches for hospitals with variance
in (1) historic care and utilization patterns; (2) patient populations
and care patterns; (3) roles within their local markets; (4) volumes of
services; (5) levels of access to financial, community, or other
resources; and (6) levels of population and health-care-provider
density, including local variations in the availability and use of
different categories of post-acute care providers. We believe that
participation in the proposed EPMs by a large number of hospitals with
diverse characteristics would result in a robust data set for
evaluating this payment approach and would stimulate the rapid
development of new evidence-based knowledge. Testing the proposed EPMs
in this manner would also allow us to learn more about patterns of
inefficient utilization of health care services and how to incentivize
quality improvement for beneficiaries receiving services in AMI, CABG,
and SHFFT episodes. This knowledge potentially could inform future
Medicare payment policies.
We propose the CR incentive payment model to test the effects on
quality of care and Medicare expenditures of providing financial
incentives to hospitals for beneficiaries hospitalized for treatment of
AMI or CABG to encourage care coordination and greater utilization of
medically necessary CR and intensive cardiac rehabilitation (ICR)
services for 90 days post-hospital discharge where the beneficiary's
overall care is paid under either an EPM or the Medicare FFS program.
Despite the evidence from multiple studies that CR services improve
health outcomes, the literature also indicates that these services are
underutilized, estimating that only about 35 percent of AMI patients
older than 50 receive this indicated treatment.4 5 6 Recent
analysis confirms a similar pattern of underutilization for Medicare
beneficiaries who are eligible for and could benefit from CR.
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\5\ Anderson L et al. Exercise-based cardiac rehabilitation for
coronary heart disease. Cochrane Database Syst Rev. 2016 Jan
5;1:CD001800.
\6\ Receipt of outpatient cardiac rehabilitation among heart
attack survivors--United States, 2005. MMWR Morbidity and mortality
weekly report. 2008 Feb 1:57(4):89-94.
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Considering the evidence demonstrating that CR/ICR services improve
long-term patient outcomes, the room for improvement in CR/ICR service
utilization for beneficiaries eligible for this benefit, and the need
for ongoing, chronic treatment for underlying coronary artery disease
(CAD) among beneficiaries that have had an AMI or a CABG, we believe
that there is a need for improved long-term care management and care
coordination for beneficiaries that have had an AMI or a CABG and that
incentivizing the use of CR/ICR services is an important component of
meeting this need. We want to reduce barriers to high-value care by
testing a financial incentive for hospitals that encourages the
management of beneficiaries that have had an AMI or a CABG in ways that
may contribute to long-term improvements in quality and reductions in
Medicare spending. We seek public comment on the proposals contained in
this proposed rule, and also on any alternatives considered.
B. Summary of the Major Provisions
1. Model Overview--EPM Episodes of Care
Under the proposed EPMs, as described further in section III.B.2.
of this proposed rule, an AMI, CABG, or SHFFT model episode would begin
with an inpatient admission to an anchor hospital assigned to one of
the following MS-DRGs upon beneficiary discharge. Acute care hospital
services furnished to beneficiaries in AMI, CABG, and SHFFT episodes
currently are paid under the Inpatient Prospective Payment System
(IPPS) through several Medicare Severity-Diagnosis Related Groups (MS-
DRGs): for AMI episodes, AMI MS-DRGs (280-282) and those Percutaneous
Coronary Intervention (PCI) MS-DRGs (246-251) representing IPPS
admissions for AMI that are treated with PCIs; CABG MS-DRGs (231-236);
and SHFFT MS-DRGs (480-482). Episodes would end 90 days after the date
of discharge from the anchor hospital, as defined under Sec. 512.2.
Defining EPMs' episodes of care in such a manner offers operational
simplicity for both providers and CMS. The proposed EPMs' episodes
would include the inpatient stays and all related care covered under
Medicare Parts A and B within the 90 days after discharge, including
hospital care, post-acute care, and physician services.
2. Model Scope
Consistent with the CJR model, we propose that acute care hospitals
would be the episode initiators and bear financial risk under the
proposed AMI, CABG and SHFFT models. In comparison to other health care
facilities, hospitals are more likely to have resources that would
allow them to appropriately coordinate and manage care throughout an
episode, and hospital staff members already are involved in hospital-
discharge planning and post-acute care recommendations for recovery,
key dimensions of high-quality and efficient care. We propose to
require all hospitals that are paid under the IPPS, have a CMS
Certification Number (CCN), and have an address located in selected
geographic areas to participate in the EPMs, with limited exceptions.
An eligible beneficiary who receives care at such a hospital will
automatically be included in the applicable EPM. We propose to select
geographic areas through a random sampling methodology.
Under the CR incentive payment model, we propose to provide a CR
incentive payment specifically to selected hospitals with financial
responsibility for AMI or CABG model episodes (hereinafter EPM-CR
participants) because they are already engaged in managing the AMI or
CABG model beneficiary's overall care for a period of time following
hospital discharge. Similarly, we believe there are opportunities to
test the same financial incentives for hospitals where the
beneficiary's overall care is paid under the Medicare FFS program.
Thus,
[[Page 50801]]
we also propose to provide a CR incentive payment specifically to
selected hospitals that are not AMI or CABG model participants
(hereinafter FFS-CR participants).
Our proposed geographic-area selection process is detailed further
in section III.B.4. of this proposed rule.
3. Payment
We propose to test the AMI, CABG, and SHFFT EPMs for 5 performance
years. The first performance year will begin July 1, 2017. During these
performance years we propose to continue paying hospitals and other
providers and suppliers according to the usual Medicare FFS payment
systems. However, after the completion of a performance year, the
Medicare claims payments for services furnished to the beneficiary
during the episode, based on claims data, would be combined to
calculate an actual episode payment. The actual episode payment would
then be reconciled against an established EPM quality-adjusted target
price. The amount of this calculation, if positive, would be paid to
the participant. This would be called a reconciliation payment. If
negative, we would require repayment from the participant hospital
beginning with episodes ending in the second quarter of performance
year 2 of the EPMs. EPM participants' quality performance also would be
assessed at reconciliation; each participant would receive a composite
quality score and a corresponding quality category. EPM participants
that achieve a quality category of ``acceptable'' or higher would be
eligible for a reconciliation payment. We also propose to phase in the
requirement that participants whose actual episode payments exceed the
quality-adjusted target price pay the difference back to Medicare
beginning for performance year 2. Under this proposal, Medicare would
not require repayment from hospitals for performance year 1 for actual
episode payments that exceed their target price in performance year 1,
and an applicable discount factor would be used for calculating
repayment amounts for performance years 2 and 3, consistent with our
final policies for the CJR model. In contrast to the CJR model, due to
the clinical characteristics and common patterns of care in AMI
episodes, we propose payment adjustments in the cases of certain
transfers and readmissions of beneficiaries to inpatient hospitals for
these episodes. These payment adjustments are discussed in detail in
section III.D.4.b.(1). of this proposed rule. We also propose to limit
how much a hospital can gain or lose based on its actual episode
payments relative to quality-adjusted target prices. Finally, we
propose additional policies to further limit the risk of high payment
cases for all participants and for special categories of participants
as described in section III.D. of this proposed rule.
In addition to the EPMs, we propose to test a CR incentive payment
model to encourage the utilization of CR/ICR services for beneficiaries
hospitalized for treatment of AMI or CABG. To determine the CR
incentive payment, we propose to count the number of CR/ICR services
for the relevant time periods under the Outpatient Prospective Payment
System (OPPS) and PFS on the basis of the presence of paid claims of
the HCPCS codes that report CR/ICR services and the units of service
billed. The initial level of the per-service CR incentive amount would
be $25 per CR/ICR service for each of the first 11 CR/ICR services paid
for by Medicare during an AMI or CABG model episode or AMI or CABG care
period. After 11 CR/ICR services are paid for by Medicare for a
beneficiary, the level of the per-service CR incentive amount would
increase to $175 per CR/ICR service for each additional CR/ICR service
paid for by Medicare during the AMI or CABG model episode or AMI care
period or CABG care period. A more detailed discussion of the CR
incentive payment is located in section VI.E.1 of this proposed rule.
The CR performance years would be the same as the performance years
proposed for the EPMs in section III.D.2.a. of this proposed rule.
Further details about the payment structure and design of the CR
incentive payment model can be found in section VI. of this proposed
rule.
4. Similar, Previous, and Concurrent Models
The proposed EPMs are informed by other models and demonstrations
currently and previously conducted by CMS, and would explore additional
ways to use episode payment to enhance coordination of care and improve
the quality of care.
We recently announced practices that will participate in the
Oncology Care Model (OCM), an episode payment model for physician
practices administering chemotherapy. Under OCM, practices will enter
into payment arrangements that include both financial and performance
accountability for episodes of care surrounding chemotherapy
administration to cancer patients. We will coordinate with other payers
to align with OCM in order to facilitate enhanced services and care at
participating practices.\7\
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\7\ More information on the OCM can be found on the Innovation
Center's Web site at http://innovation.cms.gov/initiatives/Oncology-Care/.
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CMMI previously tested innovative episode payment approaches in the
Medicare Acute Care Episode (ACE) demonstration,\8\ and, as described
in this proposed rule, currently is testing additional approaches under
the BPCI initiative and the CJR model. The ACE demonstration tested a
bundled payment approach for cardiac and orthopedic inpatient surgical
services and procedures. All Medicare Part A and Part B services
pertaining to the inpatient stay were included in the ACE demonstration
episodes of care. Evaluations of the ACE demonstration found that while
there was not strong quantitative evidence indicating improvements in
quality, there was qualitative evidence that hospitals worked to
improve processes and outcomes as a result of their participation in
the demonstration.
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\8\ Information on the ACE Demonstration can be found on the
Innovation Center's Web site at http://innovation.cms.gov/initiatives/ACE/.
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We currently are testing the BPCI initiative, which is composed of
four related payment models that link payments for multiple services
that a Medicare beneficiary receives during an episode of care into a
bundled payment. Under the initiative, entities enter into payment
arrangements with CMS that include financial and performance
accountability for episodes of care. Episodes of care under the BPCI
initiative begin with either: (1) An inpatient hospital stay or (2)
post-acute care services following a qualifying inpatient hospital
stay. The BPCI initiative is evaluating the effects of episode-based
payment approaches on patient experience of care, outcomes, and cost of
care for Medicare FFS beneficiaries. Participating organizations chose
from 48 clinical episodes, including hip and femur procedures except
major joint, acute myocardial infarction, percutaneous coronary
intervention, and coronary artery bypass graft surgery. BPCI Model 2 is
an episode payment model in which a qualifying acute care
hospitalization initiates a 30-, 60-, or 90-day episode of care. The
episode includes the inpatient stay in an acute care hospital and all
related services covered under Medicare Parts A and B during the
episode, including post-acute care services.\9\ Our experience testing
BPCI Model 2 informed the design of the three
[[Page 50802]]
proposed EPMs. Although some interim evaluation results from the BPCI
models are available, final evaluation results for the models within
the BPCI initiative are not yet available. However, we believe that
CMS' experiences with BPCI support the design of the proposed EPMs.
Stakeholders both directly and indirectly involved in testing BPCI
models have conveyed that they perceive the initiative to be an
effective mechanism for advancing better, more accountable care and
aligning providers along the care continuum. This message has been
reinforced through CMS site visits to participating entities, the
Bundled Payments summit in Washington, in-person meetings with Awardees
at CMS, and Awardee-led Affinity Group discussions. The BPCI initiative
incorporates 48 clinical episodes, including cardiac and orthopedic
episodes similar to those proposed for the AMI, CABG, and SHFFT models.
These clinical episodes are being tested by over 1200 Medicare
providers, including acute care hospitals, physician group practices,
skilled nursing facilities, and home health agencies. Cardiac and
orthopedic clinical episodes are among the most popular episodes in
BPCI, indicating that BPCI awardees participating in BPCI believe they
can reduce cost and improve quality for beneficiaries in these episodes
of care.
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\9\ More information on BPCI Model 2 can be found on the
Innovation Center's Web site at http://innovation.cms.gov/initiatives/BPCI-Model-2/.
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Our design and implementation of the CJR model, which is an episode
payment model for LEJR episodes, also informed the design of the
proposed AMI, CABG, and SHFFT EPMs. After releasing a proposed rule in
July 2015 and receiving nearly 400 comments from the public, in
November 2015 we released final regulations implementing the CJR model.
Approximately 800 acute care hospitals (approximately 23 percent of all
IPPS hospitals) now participate in the CJR model. The first CJR
performance year began on April 1, 2016. The CJR model will continue
for 5 performance years, ending on December 31, 2020. The proposed AMI,
CABG, and SHFFT models build upon our experience designing and
implementing the CJR model, including feedback from providers and other
public stakeholders during the CJR model's rulemaking and
implementation processes.
Further information of why specific elements of the models and
initiatives were incorporated into the EPMs' designs is discussed later
in this proposed rule.
5. Overlap With Ongoing CMS Efforts
We propose to exclude from participation in the AMI, CABG, and
SHFFT models certain acute care hospitals participating in BPCI Models
2 and 4 for the hip and femur procedures except major joint or for all
three of the BPCI cardiac episodes (AMI, PCI, and CABG). We propose to
exclude beneficiaries in the proposed EPMs' episodes from being
included in certain Innovation Center ACO models, the Next Generation
ACO Model and Comprehensive ESRD Care. Other CMS programs, such as the
Medicare Shared Savings Program and other accountable care organization
(ACO) or total cost of care initiatives will remain eligible for EPM
episode initiation. We propose to account for overlap, that is, where
EPM beneficiaries also are included in other models and programs to
ensure the financial policies of the models are maintained and results
and spending reductions are attributed to one model or program. More
detail on our proposed policies for accounting for provider- and
beneficiary-level overlap is discussed in section III.D.6. of this
proposed rule.
The amendments made by the Medicare Access and CHIP Reauthorization
Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015) created two paths
for eligible clinicians to link quality to payments: The Merit-Based
Incentive Payment System (MIPS) and Advanced Alternative Payment Models
(APMs). These two paths create a flexible payment system called the
Quality Payment Program as proposed by CMS in the Quality Payment
Program proposed rule (81 FR 28161 through 28586). The MIPS streamlines
and improves on three current programs--the Physician Quality Reporting
System (PQRS), the Physician Value-based Payment Modifier (VM), and the
Medicare Electronic Health Record (EHR) Incentive Program--and
continues the focus on quality and value in one cohesive program.
Through participation in Advanced APMs, eligible clinicians can become
Qualifying APM Participants (QPs) for a year beginning with CY 2019 and
receive an APM Incentive Payment (or, in later years, a more favorable
payment update under the PFS) for the year.
So that the EPMs may be able to meet the criteria to be Advanced
APMs based on the requirements proposed in the Quality Payment Program
proposed rule, we propose to require EPM participants to use Certified
Electronic Health Record Technology (CEHRT) (as defined in section
1848(o)(4) of the Act) in Track 1 of each EPM. We propose that EPM
participants in these tracks must use certified health information
technology (IT) functions, in accordance with the definition of CEHRT
under our regulation at 42 CFR 414.1305, to document and communicate
clinical care with patients and other health care professionals as
described in the Quality Payment Program proposed rule (81 FR 28161 and
28299). We also make similar proposals with respect to CJR.
We propose to implement two different tracks within the EPMs
whereby EPM participants that meet proposed requirements for use of
CEHRT and financial risk would be in Track 1 (an Advanced APM track)
and EPM participants that do not meet these requirements would be in
Track 2 (a non-Advanced APM track). The different tracks would not
change how EPM participants operate within the EPM itself, beyond the
requirements associated with selecting to meet CEHRT use requirements.
The only distinction between the two tracks is that only Track 1 EPMs
could be considered an Advanced APM for purposes of the Quality Payment
Program based on the proposed criteria in the Quality Payment Program
proposed rule. We make similar proposals with respect to CJR. We would
consider modifying requirements proposed in this rule as necessary to
reconcile them with policies adopted in the Quality Payment Program
final rule. A more detailed discussion of the proposals for how EPMs
and CJR could qualify as Advanced APMs, and how eligible clinicians
participating in the EPMs and CJR would be identified and affected, can
be found in sections III.A.2 and V.O. of this proposed rule.
6. Quality Measures and Reporting Requirements
Similar to the quality measures selected for the CJR model, we
propose to use established measures used in other CMS quality-reporting
programs for the proposed EPMs' episodes. We propose to use these
measures to test EPMs' success in achieving its goals under section
1115A of the Act and to monitor for beneficiary safety. For the SHFFT
model, we propose applying the same quality measures selected for the
CJR model.
The following proposed quality measures for SHFFT episodes are:
THA/TKA Complications: Hospital-Level Risk-Standardized
Complication Rate (RSCR) Following Elective Primary Total Hip
Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) (National
Quality Forum [NQF] #1550)
Hospital Consumer Assessment of Healthcare Providers and
Systems (HCAPHS) Survey (NQF #0166)
Successful Voluntary Reporting of Patient-Reported Outcomes
[[Page 50803]]
We propose the following measures for the AMI model:
MORT-30-AMI: Hospital 30-Day, All-Cause, Risk-Standardized
Mortality Rate (RSMR) Following Acute Myocardial Infarction (AMI)
Hospitalization (NQF #0230).
AMI Excess Days: Excess Days in Acute Care after
Hospitalization for Acute Myocardial Infarction (acute care days
include emergency department, observation, and inpatient readmission
days)
HCAPHS Survey (NQF #0166), linear mean roll-up (HLMR) scores
like CJR
We propose the following measures for the CABG model:
MORT-30-CABG: Hospital 30-Day, All-Cause, Risk-Standardized
Mortality Rate (RSMR) Following Coronary Artery Bypass Graft Surgery
(NQF #2558)
HCAPHS Survey (NQF #0166), HLMR scores like CJR
Finally, we are proposing and requesting public feedback on options
for including successful implementation testing of the Hybrid AMI
measure as a quality measure for the AMI episode. The Hybrid AMI
measure will assess a hospital's 30-day risk-standardized acute
myocardial infarction mortality rate and will incorporate a combination
of claims data and EHR data submitted by hospitals.
Additionally, similar to the CJR model, we propose to adopt a pay-
for-performance methodology for EPMs that relies upon a composite
quality score to assign respective EPM participants to four quality
categories. These quality categories will determine an EPM
participant's eligibility for a reconciliation payment should such EPM
participant achieve spending below the quality-adjusted target price,
as well as the effective discount percentage at reconciliation. Points
for quality performance and improvement (as applicable) will be awarded
for each episode measure and then summed to develop a composite quality
score that will determine the EPM participant's quality category for
the episode. Quality performance will make up the majority of available
points in the composite quality score, with improvement points
available as ``bonus'' points for the measure. This approach resembles
the CJR model methodology.
7. Beneficiary Protections
As with the CJR model, Medicare beneficiaries in the proposed
models will retain the right to obtain health services from any
individual or organization qualified to participate in the Medicare
program. Eligible beneficiaries who receive services from model
participants would not have the option to opt out of inclusion in the
applicable model. We propose to require participants to supply
beneficiaries with written information regarding the design and
implications of these models as well as the beneficiaries' rights under
Medicare, including their right to use their providers of choice. We
would make a robust effort to reach out to beneficiaries and their
advocates to help them understand the models. We also propose to use
our existing authority, if necessary, to audit participant hospitals if
claims analysis indicates an inappropriate change in delivered
services. Beneficiary protections are discussed in greater depth in
section III.G. of this proposed rule.
8. Financial Arrangements
We propose to use the same general framework finalized in the CJR
model to hold participants financially responsible for AMI, CABG and
SHFFT model episodes as discussed in section III.I. of this proposed
rule. Specifically, only the EPM participants would be directly subject
to the requirements of this proposed rule for the proposed EPMs. EPM
participants would be responsible for ensuring that other providers and
suppliers collaborating with the EPM participants on care redesign for
the applicable EPM episodes are in compliance with the applicable EPM's
terms and conditions.
We propose adding hospitals to the list of providers and suppliers
eligible for gainsharing as EPM collaborators due to the expected
participation of multiple hospitals in the episode care for some
beneficiaries in AMI and CABG episodes. We further propose adding ACOs
to be eligible for gainsharing as EPM collaborators due to the interest
of ACOs in gainsharing during the CJR model rulemaking and the ongoing
challenges of addressing overlap between episode payment models and
ACOs. We also propose provisions that allow for certain gainsharing
within ACOs, detailed further in section III.I. of this proposed rule.
In contrast, the CR incentive payment model is specifically tied to
increased utilization of CR/ICR services within AMI and CABG model
episodes and, therefore, is designed to reward increased referral of
AMI and CABG model beneficiaries to CR/ICR programs, as well as
supporting beneficiary adherence to the referral and participation in
CR/ICR services, rather than the quality and efficiency of EPM episodes
themselves. Thus, we do not propose to allow CR incentive payments to
be included in sharing arrangements, and the CR incentive payments may
be shared with other individual and entities only under circumstances
which comply with all existing laws and regulations, including fraud
and abuse laws. Financial arrangements are discussed in further detail
in section VI.E. of the proposed rule.
9. Data Sharing
Based on our experience with various Medicare programs and models,
including the BPCI initiative, the CJR model, the Shared Savings
Program, and the Pioneer ACO model, we believe that providing certain
beneficiary claims data to model participants will be essential to
their success. We propose to share data with participants upon request
throughout the performance period of the models to the extent permitted
by the Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule and other applicable law. We propose to share upon
request both raw claims-level data and claims summary data with
participants. This approach would allow participants without prior
experience analyzing claims to use summary data for analysis of care
and spending patterns, while allowing those participants who prefer raw
claims-level data the opportunity to analyze claims. We propose to
provide participants with up to 3 years of retrospective claims data
upon request that will be used to develop their quality-adjusted target
price. In accordance with the HIPAA Privacy Rule, we would limit the
content of this data to the minimum data necessary for the participant
to conduct quality assessment and improvement activities and
effectively coordinate care.
10. Program Waivers
Section 1115A of the Act authorizes the Secretary to waive Medicare
program requirements as necessary to implement provisions for testing
models. Under the CJR model, CMS waived certain program rules regarding
the direct supervision requirement for certain post-discharge home
visits, telehealth services, and the skilled nursing facility (SNF) 3-
day rule. CMS finalized these waivers to offer providers and suppliers
more flexibility so that they may increase coordination of care and
management of beneficiaries in model episodes. Adopting the CJR waivers
for the proposed EPMs required further examination to determine if such
adoption would increase financial vulnerability to the Medicare program
or would create inappropriate incentives to reduce the quality of
[[Page 50804]]
beneficiary care. As discussed in section III.J. of this proposed rule,
we propose to do the following:
Adopt waivers of the telehealth originating site and
geographic site requirement and to allow in-home telehealth visits for
all three proposed EPMs, as well as the general waiver to allow post-
discharge nursing visits in the home;
Provide model-specific limits to the number of post-
discharge nursing visits and make model-specific decisions about
offering the SNF 3-day stay waiver; and
Adopt a waiver for furnishing cardiac and intensive
cardiac rehabilitation services to allow a Nurse Practitioner, Clinical
Nurse Specialist, or Physician Assistant, in addition to a physician,
to perform specific physician functions.
C. Summary of Economic Effects
As shown in our impact analysis, we expect the EPMs to result in
savings to Medicare of $170 million over the 5 performance years of the
model. We note that a composite quality score will be calculated for
each hospital in order to determine eligibility for a reconciliation
payment and whether the hospital qualifies for quality incentive
payments that will reduce the effective discount percentage experience
by the hospital at reconciliation for a given performance year.
More specifically, in performance year 1 of the model, we estimate
a Medicare cost of approximately $12 million, as hospitals will not be
subject to downside risk in the first year and the first quarter of the
second performance year of the model. As we introduce downside risk
beginning in the second quarter of performance year 2 of the model, we
estimate Medicare savings of approximately $13 million. In performance
year 3 of the model, we estimate Medicare savings of $30 million. In
performance years 4 and 5 of the model, we will move from target
episode pricing that is based on a hospital's experience to target
pricing based on regional experience, and we estimate Medicare savings
of $61 million and $79 million, respectively.
As a result, we estimate the net savings to Medicare to be $170
million over the 5 performance years of the model. We anticipate there
will be a broader focus on care coordination and quality improvement
for EPMs among hospitals and other providers and suppliers within the
Medicare program that will lead to both increased efficiency in the
provision of care and improved quality of the care provided to
beneficiaries.
Additionally, the CR incentive model estimates that the impact on
the Medicare program may range from up to $27 million of additional
spending to $32 million of savings between 2017 and 2024, depending on
the change in utilization of CR/ICR services based on the proposed
incentive structure.
Finally, the change in the estimated net financial impact to the
Medicare program from the CJR model modifications in this proposed rule
is $22 million in spending, and the updated assumptions regarding the
number of hospitals that will report quality data result in an increase
of $14 million dollars in spending. The total estimated net financial
impact to the Medicare program from both the modifications in the
proposed rule and revised assumptions are $35 million in spending.
We note that under section 1115A(b)(3)(B) of the Act, the Secretary
is required to terminate or modify a model unless certain findings can
be made with respect to savings and quality after the model has begun.
If during the course of testing the model it is determined that
termination or modification is necessary, such actions will be
undertaken through rulemaking.
II. Background
This proposed rule proposes the implementation of three new EPMs
and a CR incentive payment model under the authority of section 1115A
of the Act. Under the AMI, CABG, and SHFFT EPMs, acute care hospitals
in certain selected geographic areas will be financially accountable
for quality performance and spending for applicable episodes of care.
We propose to retrospectively apply through a reconciliation process
the episode payment methodology; hospitals and other providers and
suppliers would continue to submit claims and receive payment via the
usual Medicare FFS payment systems throughout the proposed EPMs'
performance years. Hospitals participating in the proposed EPMs would
receive target prices, which reflect expected spending for care during
an episode as well as a discount to reflect savings to Medicare, on a
prospective basis, prior to the beginning of a performance year. All
related care covered under Medicare Parts A and B and furnished within
90 days after the date of hospital discharge from the anchor
hospitalization which initiated the applicable EPM episode would be
included in the episode of care. We believe the proposed models will
further our goals of improving the efficiency and quality of care for
Medicare beneficiaries for these medical conditions and procedures.
III. Provisions of the Proposed Regulations
A. Selection of Episodes, Advanced Alternative Payment Model
Considerations, and Future Directions
1. Selection of Episodes for Episode Payment Models in This Rulemaking
a. Overview
CMS has been engaged since 2013 in testing various approaches to
episode payment for Medicare FFS beneficiaries for 48 clinical episodes
in the BPCI initiative. As of April 1, 2016, the BPCI initiative has
1,522 participants in the risk-bearing phase, comprised of 321 Awardees
and 1,201 Episode Initiators. The breakdown of BPCI participants by
provider type is as follows: Acute care hospitals (385); skilled
nursing facilities (681); physician group practices (283); home health
agencies (99); inpatient rehabilitation facilities (9); and long-term
care hospitals (1).\10\ In BPCI Models 2 and 3, there is participation
across all 48 clinical episodes, and in Model 4 there is participation
in 19 clinical episodes. The 10 clinical episodes with the most
participation are: major joint replacement of the lower extremity;
simple pneumonia and respiratory infections; congestive heart failure;
chronic obstructive pulmonary disease; bronchitis; asthma; hip and
femur procedures except major joint; sepsis; urinary tract infection;
acute myocardial infarction (medical management only); medical non-
infectious orthopedic; and other respiratory.\11\
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\10\ https://innovation.cms.gov/initiatives/bundled-payments/.
\11\ https://innovation.cms.gov/Files/x/bpcianalyticfile.xlsx.
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In November 2015, CMS released the Final Rule for the Comprehensive
Care for Joint Replacement (CJR) model (80 FR 73274 through 73554), the
first test of episode payment for Medicare FFS beneficiaries in which
providers are required to participate. The CJR model, which began on
April 1, 2016, focuses on the episode-of-care for lower-extremity joint
replacement (LEJR) procedures. As discussed in the Final Rule (80 FR
73277), LEJR episodes were chosen for the CJR model because they
represent one of the most common high-expenditure, high-utilization
procedures furnished to Medicare beneficiaries and have significant
variation in episode spending. We believe this high volume, coupled
with substantial variation in utilization and spending across
individual providers and geographic
[[Page 50805]]
regions, created a significant opportunity to test whether an episode
payment model focused on a defined set of procedures could improve the
quality and coordination of care, as well as result in savings to
Medicare. Notably, both BPCI and the CJR model are focused on care that
is related to an inpatient hospitalization, with CJR and BPCI Model 2
episodes beginning with an inpatient hospitalization (anchor
hospitalization) and extending up to 90 days post-hospital discharge.
In this rulemaking, we propose three new EPMs that, like the CJR
model, would require provider participation in selected geographic
areas. Episodes in the new EPMs would begin with admissions for
hospitalizations in IPPS hospitals, and would extend 90 days post-
hospital discharge. The episodes included in these three EPMs are AMI,
CABG, and SHFFT excluding lower extremity joint replacement. The
proposed AMI model includes beneficiaries discharged under AMI MS-DRGs
(280-282), representing IPPS admissions for AMI that are treated with
medical management. The proposed AMI model also includes beneficiaries
discharged under PCI MS-DRGs (246-251) with AMI International
Classification of Disease, Tenth Edition, Clinical Modification (ICD-
10-CM) diagnosis codes for initial AMI diagnoses in the principal or
secondary diagnosis code positions, representing IPPS admissions for
AMI that are treated with PCIs. The proposed CABG model includes
beneficiaries discharged under CABG MS-DRGs (231-236), representing
IPPS admissions for this coronary revascularization procedure
irrespective of AMI diagnosis. The proposed SHFFT model includes
beneficiaries discharged under hip and femur procedures except major
joint replacement MS-DRGs (480-482), representing IPPS admissions for
hip-fixation procedures in the setting of hip fractures.
Similar to the selection of LEJR episodes for the CJR model (80 FR
73277), we selected the AMI, CABG, and SHFFT episodes because they
represent high-expenditure, high-volume episodes-of-care experienced by
Medicare beneficiaries. Based on analysis of historical episodes
beginning in CY 2012-2014, the average annual number of historical
episodes that began with IPPS hospitalizations and extended 90 days
post-hospital discharge, and therefore would have been included in the
proposed models, is approximately 168,000 for AMI; 48,000 for CABG; and
109,000 for SHFFT.\12\ The total annual Medicare spending for these
historical episodes was approximately $4.1 billion, $2.3 billion, and
$4.7 billion, respectively.\13\ Each of the episodes provides different
opportunities in an EPM to improve the coordination and quality of
care, as well as efficiency of care during the episode, based on
varying current patterns of utilization and Medicare spending.
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\12\ Episodes for AMI, CABG, and SHFFT beneficiaries initiated
by all U.S. IPPS hospitals not in Maryland and constructed using
standardized Medicare FFS Parts A and B claims, as proposed in this
rule that began in CY 2012-2014.
\13\ Episodes for AMI, CABG, and SHFFT beneficiaries initiated
by all U.S. IPPS hospitals not in Maryland and constructed using
standardized Medicare FFS Parts A and B claims, as proposed in this
rule that began in CY 2012-2014.
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However, in contrast to LEJR episodes in CJR, which are
predominantly elective and during which hospital readmissions are rare
and substantial post-acute care provider utilization is common, the
proposed AMI, CABG, and SHFFT model episodes have very different
current patterns of care. Beneficiaries in these episodes commonly have
chronic conditions that contribute to the initiation of the episodes
and need both planned and unplanned care throughout the EPM episode
following discharge from the initial hospitalization that begins the
episode. Both AMI and CABG model episodes primarily include
beneficiaries with cardiovascular disease, a chronic condition which
likely contributed to the acute events or procedures that initiate the
episodes. About half the average AMI model historical episode spending
was for the initial hospitalization, with the majority of spending
following discharge from the initial hospitalization due to hospital
readmissions, while there was relatively less spending on SNF services,
Part B professional services, and hospital outpatient services. In CABG
model historical episodes, about three-quarters of episode spending was
for the initial hospitalization, with the remaining episode spending
relatively evenly divided between Part B professional services and
hospital readmissions, and a lesser percentage on SNF services. Similar
to AMI episodes, post-acute care provider use was relatively uncommon
in CABG model historical episodes, while hospital readmissions during
CABG model historical episodes were relatively common. SHFFT model
historical episodes also were accompanied by substantial spending for
hospital readmissions, and post-acute care provider use in these
episodes also was high.\14\ The number of affected beneficiaries and
potential impact of the models on quality and Medicare spending present
an important opportunity to further the Administration's goal of
shifting health care payments to support the quality of care over the
quantity of services by promoting better coordination among health care
providers and suppliers and greater efficiency in the care of
beneficiaries in these models, while reducing Medicare
expenditures.\15\ Pay-for-performance episode payment models such as
the three EPMs proposed in this rulemaking financially incentivize
improved quality of care and reduced cost by aligning the financial
incentives of all providers and suppliers caring for model
beneficiaries with these goals. This alignment leads to a heightened
focus on care coordination and management throughout the episode that
prioritizes the provision of those items and services which improve
beneficiary outcomes and experience at the lowest cost.
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\14\ Episodes for AMI, CABG, and SHFFT beneficiaries initiated
by all U.S. IPPS hospitals not in Maryland and constructed using
standardized Medicare FFS Parts A and B claims, as proposed in this
rule that end in CY 2014.
\15\ Sylvia Mathews Burwell, HHS Secretary, Progress Towards
Achieving Better Care, Smarter Spending, Healthier People, http://www.hhs.gov/blog/2015/01/26/progress-towards-better-care-msarter-spending-healthier-people.html (January 26, 2015).
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We selected all of the proposed EPM episodes based on their
clinical homogeneity, site-of-service, and MS-DRG assignment
considerations. We anticipate these proposed new EPMs, like the CJR
model, would benefit Medicare beneficiaries by improving the
coordination and transition of care among various care settings to
facilitate beneficiaries' return to their communities as their
recoveries progress, improving the coordination of items and services
paid through Medicare FFS, encouraging more provider investment in
infrastructure and redesigned care processes for higher quality and
more efficient service delivery, and incentivizing higher value care
across the inpatient and post-acute care spectrum spanning the episode-
of-care (80 FR 73276). However, improving value in the EPMs through
these means requires a cohort of beneficiaries with similar clinical
features such that coordination and care redesign efforts can be
targeted. Therefore, we propose EPM episodes built on common pathologic
and treatment processes; that is, beneficiaries included in both the
AMI and CABG models have cardiovascular pathologies that drive their
clinical courses during the
[[Page 50806]]
episodes, and SHFFT model beneficiaries all share similar diagnoses of
hip fracture and treatment with hip fixation that drive their clinical
courses during their respective episodes.
b. SHFFT Model
The SHFFT model was selected to complement the CJR model. The SHFFT
model is being tested in the same hospitals participating in the CJR
model as discussed in section III.B.4 of this proposed rule, so that
all surgical treatment options for Medicare beneficiaries with hip
fracture (hip arthroplasty and fixation) would be included in episode
payment models. Hip fracture is a serious and sometimes catastrophic
event for Medicare beneficiaries. In 2010, 258,000 people aged 65 and
older were admitted to the hospital for hip fracture, with an estimated
$20 billion in lifetime cost for all hip fractures in the United States
in a single year.\16\ In 2013, fracture of the neck of the femur (the
most common location for hip fracture) was the eighth most common
principal discharge diagnosis for hospitalized Medicare FFS
beneficiaries, constituting 2.7 percent of discharges.\17\ Mortality
associated with hip fracture is 5-10 percent after 1 month and
approximately 33 percent at 1 year.\18\ Hip arthroplasty and hip
fixation, or ``hip pinning,'' represent the two broad surgical options
for treating hip fractures.\19\ The CJR model episodes begin with
admission to acute care hospitals for LEJR procedures assigned to MS-
DRG 469 (Major joint replacement or reattachment of lower extremity
with major complications or comorbidities) or MS-DRG 470 (Major joint
replacement or reattachment of lower extremity without major
complications or comorbidities) upon beneficiary discharge and paid
under the IPPS, including total and partial hip replacement in the
setting of hip fracture (80 FR 73280). Therefore, the SHFFT model,
which would additionally test an episode payment for hip fixation,
provides an opportunity to complete the transition to episode payment
for the surgical treatment and recovery of the significant clinical
condition of hip fracture.
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\16\ Smith et al. Increase in Disability Prevalence Before Hip
Fracture. J Am Geriatr Soc. 2015 Oct;63(10):2029-35.
\17\ Krumholz HM, Nuti SV, Downing NS, Normand ST, Wang Y.
Mortality, Hospitalizations, and Expenditures for the Medicare
Population Aged 65 Years or Older, 1999-2013. JAMA. 2015;
314(4):355-365.
\18\ Parker et al. Hip Fracture. BMJ. 2006 Jul 1;333(7557):27-
30.
\19\ American Academy of Orthopaedic Surgeons, OrthoInfo: Hip
Fractures, http://orthoinfo.aaos.org (April 12, 2016).
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c. AMI and CABG Models
The AMI and CABG models, which we propose to be tested at a single
set of hospitals as discussed in section III.B.5 of this proposed rule,
were selected to include all beneficiaries who have an AMI treated
medically or with revascularization with PCI, as well as all
beneficiaries who undergo CABG (whether performed during the care of an
AMI or performed electively for stable ischemic heart disease or other
indication). Both cardiac models represent clinical conditions that
result in a significant burden of morbidity and expenditures in the
Medicare population. CABG typically is the preferred revascularization
modality for patients with ST elevation AMI where the coronary anatomy
is not amenable to PCI or there is a mechanical complication (for
example, ventricular septal defect, rupture of the free wall of the
ventricle, or papillary-muscle rupture with severe mitral
regurgitation); for patients with CAD other than ST elevation AMI where
there is left main coronary artery disease or multi-vessel disease with
complex lesions; and for patients with clinically significant CAD in at
least one vessel and refractory symptoms despite medical therapy and
PCI.\20\ Despite the greater acute morbidity related to major
cardiothoracic surgery, CABG is associated with lower longer-term rates
of major adverse cardiac and cerebrovascular events in comparison to
PCI for certain groups of patients.\21\ Moreover, a recent study found
that in a group of patients with ischemic cardiomyopathy, the rates of
death from any cause, death from cardiovascular causes, and death from
any cause or hospitalization for cardiovascular causes were
significantly lower over 10 years among patients who underwent CABG in
addition to receiving medical therapy than among those who received
medical therapy alone.\22\ While about 30 percent of CABGs are
performed during the care of AMIs, we propose to include these
particular AMI beneficiaries generally in the same episode as CABG for
other indications, rather than in the AMI episode, since we anticipate
hospitals will seek to improve the quality and efficiency of care for
that surgical intervention, regardless of indication.\23\
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\20\ Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N
Engl J Med. 2016 May 19;374(2):1954-1964.
\21\ Sepehripour et al. Developments in surgical
revascularization to achieve improved morbidity and mortality.
Expert Rev Cardiovasc Ther. 2016 Mar;14(3):367-79. doi: 10.1586/
14779072.2016.1123619. Epub 2015 Dec 17.
\22\ Velazquez et al. Coronary Artery Bypass Surgery in Patients
with Ischemic Cardiomyopathy. N Engl J Med. 2016 Apr 3.
\23\ Episodes for CABG beneficiaries initiated by all U.S. IPPS
hospitals not in Maryland and constructed using standardized
Medicare FFS Parts A and B claims, as proposed in this rule, that
end in CY 2014.
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We propose AMI as the episode for an EPM because we recognize it as
a significant clinical condition for which evidence-based clinical
guidelines are available for the most common AMI scenarios that begin
with a beneficiary's presentation for urgent care, most commonly to a
hospital emergency department. The hospital phase involves medical
management for all patients, as well as potential revascularization,
most commonly with PCI. Secondary prevention and plans for long-term
management begin early during the hospitalization and extend following
hospital discharge and are addressed in clinical
guidelines.24 25 The AMI model is the first Innovation
Center episode payment model that includes substantially different
clinical care pathways (medical management and PCI) for a single
clinical condition in one episode in a model and, as such, represents
an important next step in testing episode payment models for clinical
conditions which involve a variety of different approaches to treatment
and management.
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\24\ Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats
TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN,
Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW,
Zieman SJ. 2014 ACC/AHA guideline for the management of patients
with non-ST-elevation acute coronary syndromes: a report of the
American College of Cardiology/American Heart Association Task Force
on Practice Guidelines. Circulation. 2014;130:e344-e426.
\25\ O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK,
de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger
CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP,Ou N,
Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX.
2013 ACCF/AHA guideline for the management of ST-elevation
myocardial infarction: a report of the American College of
Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines. Circulation. 2013;127:
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The American Heart Association estimates that every 42 seconds,
someone in the United States has a myocardial infarction.\26\ AMI
remains
[[Page 50807]]
one of the most common hospital diagnoses among Medicare FFS
beneficiaries, and almost 20 percent of beneficiaries discharged for
AMI are readmitted within 30 days of hospital
discharge.27 28 In 2013, AMI was the sixth most common
principal discharge diagnosis for hospitalized Medicare FFS
beneficiaries, constituting 2.9 percent of discharges.\29\ Of the
approximately 395,000 Medicare FFS beneficiaries with short-term acute
care hospital discharges (excluding Maryland) for AMI in FY 2014, 60
percent were discharged under MS-DRGs proposed to be included in the
AMI model, specifically 33 percent under AMI MS-DRGs and 25 percent
under PCI MS-DRGs.\30\ An additional 3 percent of beneficiaries were in
MS-DRGs assigned for death from AMI in the hospital. Although 5 percent
of beneficiaries with hospital discharges for AMI were discharged under
CABG MS-DRGs, we note that because both PCI and fibrinolysis can
restore blood flow in an acutely occluded coronary artery more quickly
than CABG, these interventions are currently preferred to CABG in most
cases of AMI. Furthermore, over recent years cardiovascular clinical
practice patterns have generally shifted away from surgical treatment
of coronary artery occlusion toward percutaneous, catheter-based
interventions.\31\ The remaining 34 percent of beneficiaries with AMI
diagnoses were distributed across a heterogeneous group of over 300
other MS-DRGs, such as septicemia, respiratory system diagnosis with
ventilator support, and major cardiovascular procedures. For this
latter group of beneficiaries, the AMI diagnosis appeared in a
secondary position on the hospital claim in more than 90 percent of the
cases, therefore most likely representing circumstances where the
beneficiary hospitalized for another clinical condition experienced an
AMI during the hospital stay. By focusing the AMI model on AMIs treated
medically or with revascularization with PCI, we propose to test a
condition-specific EPM that is discretely defined and includes a
significant majority of beneficiaries with AMI in the AMI model. In CYs
2012-2014, the average Medicare spending for an AMI episode that
extends 90 days post-hospital discharge was approximately $24,200.\32\
From the AMI model, we expect to better understand the impact such an
EPM can have on efficiency and quality of care for beneficiaries across
the entire spectrum of AMI care, including diagnosis, treatment, and
recovery, as well as short-term secondary prevention.
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\26\ Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ,
Cushman M, Das SR, de Ferranti S, Despr[eacute]s J-P, Fullerton HJ,
Howard VJ, Huffman MD, Isasi CR, Jim[eacute]nez MC, Judd SE, Kissela
BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire
DK, Mohler ER III, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar
RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ,
Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo
D, Yeh RW, Turner MB; on behalf of the American Heart Association
Statistics Committee and Stroke Statistics Subcommittee. Heart
disease and stroke statistics--2016 update: A report from the
American Heart Association. Circulation. 2016 Jan 26; 133(4):447-54.
\27\ Krumholz HM, Nuti SV, Downing NS, Normand ST, Wang Y.
Mortality, Hospitalizations, and Expenditures for the Medicare
Population Aged 65 Years or Older, 1999-2013. JAMA. 2015;
314(4):355-365.
\28\ Dharmarajan K, Hsieh AF, Lin Z et al. Diagnoses and Timing
of 30-Day Readmissions After Hospitalization for Heart Failure,
Acute Myocardial Infarction, or Pneumonia. JAMA. 2013; 309(4):355-
363.
\29\ Krumholz HM, Nuti SV, Downing NS, Normand ST, Wang Y.
Mortality, Hospitalizations, and Expenditures for the Medicare
Population Aged 65 Years or Older, 1999-2013. JAMA. 2015;
314(4):355-365.
\30\ Inpatient claims from all U.S. IPPS hospitals not in
Maryland were derived from the October 2013-September 2014 Inpatient
Claims File located in the Chronic Conditions Warehouse.
\31\ Epstein et al. JAMA. 2011 May 4; 305(17): 1769-1776.
\32\ Episodes for beneficiaries with AMI diagnosis initiated by
all U.S. IPPS hospitals not in Maryland and constructed using
standardized Medicare FFS Parts A and B claims, as proposed in this
rule that began in CYs 2012-2014.
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Beneficiaries in the proposed AMI and CABG models would all have
CAD. In 2010 in the U.S, the prevalence of CAD in the population 65
years and older was about 20 percent.\33\ Patients with CAD also often
experience other conditions with significant health-related
implications, including diabetes. To improve care for patients with
CAD, most approaches in the private and public sectors focus on
improving the efficiency and quality of care around procedures such as
PCI and CABG. The BPCI models are an example of such an approach. As
discussed previously in this section, our proposal for the AMI model
extends beyond a procedure-based EPM to include beneficiaries
hospitalized for medical management or PCI for AMI in a single EPM, and
we propose to test the CABG model, which also would include
beneficiaries with AMI, at the same participant hospitals. We believe
that hospitalization for AMI, whether accompanied solely by medical
management or including revascularization during the initial
hospitalization or in a planned CABG readmission, is a sentinel event
indicating the need for an increased focus on condition-specific
management, as well as on care coordination and active management to
prevent future acute events, both during the AMI and CABG model
episodes and beyond. We also believe that improving the quality and
efficiency of CAD care over a long period of time is important given
the chronic nature of this condition that has serious implications for
beneficiary health.
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\33\ National Center for Chronic Disease Prevention and Health
Promotion, Division for Heart Disease and Stroke Prevention, August
10, 2015.
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The AMI and CABG models provide an opportunity for us to
incentivize CAD-specific care management and care coordination for AMI
and CABG model beneficiaries that lay the groundwork for longer-term
improvements in quality and efficiency of care for beneficiaries with
CAD. We note that the quality measures proposed for use in the pay-for-
performance methodologies of the AMI and CABG models do not currently
include longer-term outcomes or patient experience outside of the AMI
or CABG model episode itself, as discussed in sections III.E.2.b. and
c. of this proposed rule, although we are interested in comments about
potential future measures that could incorporate longer-term outcomes.
Moreover, as discussed in section VI. of this proposed rule, we also
propose to test a cardiac rehabilitation (CR)/intensive cardiac
rehabilitation (ICR) incentive payment, hereinafter CR incentive
payment, in AMI and CABG model participants located in some of the MSAs
selected for AMI and CABG model participation, as well as in hospitals
located in some of the MSAs that are not selected for AMI or CABG model
participation. We would evaluate the effects of the CR incentive
payment in the context of an episode payment model and Medicare FFS on
utilization of CR/ICR, as well as short-term (within the period of time
extending 90 days following hospital discharge from an AMI or CABG
hospitalization) and longer-term outcomes. We believe this test may
result in valuable findings about effective strategies to increase
utilization of CR/ICR services that have a strong evidence-base for
their effectiveness but a long history of underutilization.
2. Advanced Alternative Payment Model Considerations
a. Overview for the EPMs
The MACRA created two paths for eligible clinicians to link quality
to payments: The MIPS and Advanced APMs. These two paths create a
flexible payment system called the Quality Payment Program as proposed
by CMS in the Quality Payment Program proposed rule (81 FR 28161
through 28586).
As proposed in the Quality Payment Program proposed rule, an APM
must meet three criteria to be considered an Advanced APM (81 FR
28298). First, the APM must provide for payment for covered
professional services based on quality measures comparable to measures
described under the
[[Page 50808]]
performance category described in section 1848(q)(2)(B)(i) of the Act,
which is the MIPS quality performance category. Under the Quality
Payment Program proposed rule, we proposed that the quality measures on
which the Advanced APM bases payment for covered professional services
(as that term is defined in section 1848(k)(3)(A) of the Act) must
include at least one of the following types of measures, provided that
they have an evidence-based focus and are reliable and valid (81 FR
28302):
Any of the quality measures included on the proposed
annual list of MIPS quality measures.
Quality measures that are endorsed by a consensus-based
entity.
Quality measures developed under section 1848(s) of the
Act.
Quality measures submitted in response to the MIPS Call
for Quality Measures under section 1848(q)(2)(D)(ii) of the Act.
Any other quality measures that CMS determines to have an
evidence-based focus and be reliable and valid.
As we discussed in the Quality Payment Program proposed rule,
because the statute identifies outcome measures as a priority measure
type and we wanted to encourage the use of outcome measures for quality
performance assessment in APMs, we further proposed in that rule that,
in addition to the general quality measure requirements, an Advanced
APM must include at least one outcome measure if an appropriate measure
is available on the MIPS list of measures for that specific QP
Performance Period, determined at the time when the APM is first
established (81 FR 28302 through 28303).
Second, the APM must either require that participating APM Entities
bear risk for monetary losses of a more than nominal amount under the
APM or be a Medical Home Model expanded under section 1115A(c) of the
Act. Except for Medical Home Models, we proposed in the Quality Payment
Program proposed rule that, for an APM to meet the nominal amount
standard, the specific level of marginal risk must be at least 30
percent of losses in excess of expected expenditures; a minimum loss
rate, to the extent applicable, must be no greater than 4 percent of
expected expenditures; and total potential risk must be at least 4
percent of expected expenditures (81 FR 28306).
Third, the APM must require participants to use CEHRT (as defined
in section 1848(o)(4) of the Act), as specified in section
1833(z)(3)(D)(i)(I) of the Act, to document and communicate clinical
care with patients and other health care professionals. Specifically,
where the APM participants are hospitals, the APM must require each
hospital to use CEHRT (81 FR 28298 through 28299).
In this proposed rule, we propose to adopt two different tracks for
the EPMs--Track 1 in which EPMs and EPM participants would meet the
criteria for Advanced APMs as proposed in the Quality Payment Program
proposed rule, and Track 2 in which the EPMs and EPM participants would
not meet those proposed criteria. For the proposed AMI, CABG, and SHFFT
models, we propose pay-for-performance methodologies that use quality
measures that we believe would meet the proposed Advanced APM quality
measure requirements in the Quality Payment Program proposed rule. As
discussed in sections III.E.2. and 3. of this proposed rule, all but
one of the AMI, CABG, and SHFFT model measures used in the EPM pay-for-
performance methodologies are NQF-endorsed and have an evidence-based
focus and are reliable and valid. Therefore, we believe they would meet
the proposed Advanced APM general quality measure requirements. The
Excess Days in Acute Care after Hospitalization for AMI (AMI Excess
Days) measure, which is proposed for the AMI model, is not currently
NQF-endorsed, but we believe it meets the measure requirements by
having an evidence-based focus and being reliable and valid because
this measure has been proposed and adopted through rulemaking for use
in the Hospital Inpatient Quality Reporting (HIQR) Program.
Each of the proposed EPM pay-for-performance methodologies includes
one outcome measure that is NQF-endorsed, has an evidence-based focus,
and is reliable and valid. The EPM quality measures are discussed in
detail in section III.E. of this proposed rule, where we assign the
quality measures to quality domains. For the AMI model, we propose to
use the Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate
(RSMR) Following Acute Myocardial Infarction (NQF #0230) (MORT-30-AMI)
outcome measure. For the CABG model, we propose to use the Hospital 30-
Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following
Coronary Artery Bypass Graft (CABG) Surgery (NQF# 2558) (MORT-30-CABG)
outcome measure. Finally, for the SHFFT model, we propose to use the
Hospital-level RSCR following elective primary THA and/or TKA (NQF
#1550) (Hip/Knee Complications) outcome measure. Thus, based on the
proposed use of these three outcomes measures in the EPMs, we believe
the proposed AMI, CABG, and SHFFT models would meet the requirement
proposed for Advanced APMs in the Quality Payment Program proposed rule
for use of an outcome measure that also meets the general quality
measure requirements.
In terms of the proposed nominal risk criteria for Advanced APMs,
beginning in performance year 2 for episodes ending between April 1,
2018 and December 31, 2018, EPM participants would begin to bear
downside risk for excess actual EPM-episode spending above the quality-
adjusted target price as discussed in section III.D.2.c. of this
proposed rule. The marginal risk for excess actual EPM-episode spending
above the quality-adjusted target price would be 100 percent over the
range of spending up to the stop-loss limit, which would exceed 30
percent marginal risk, and there would be no minimum loss rate. As a
result, we believe the EPMs would meet the marginal risk and minimum
loss rate elements of the nominal risk criteria for Advanced APMs
proposed in the Quality Payment Program proposed rule. Total potential
risk for most EPM participants would be 5 percent of expected
expenditures beginning in the second quarter of performance year 2, and
increasing in subsequent performance years as discussed in section
III.D.7.b. of this proposed rule. Therefore, we believe the total
potential risk applicable to most EPM participants, with the lowest
total potential risk being 5 percent for EPM episodes ending on or
after April 1, 2018 in performance year 2, would meet the total
potential risk element of the nominal risk amount standard for Advanced
APMs proposed in the Quality Payment Program proposed rule because it
is greater than the value of at least 4 percent of expected
expenditures.
We note that we propose that EPM participants that are rural
hospitals, sole community hospitals (SCHs), Medicare Dependent
Hospitals (MDHs) and Rural Referral Centers (RRCs) would have a stop-
loss limit of 3 percent beginning in the second quarter of performance
year 2 as discussed in section III.D.7.c. of this proposed rule.
Because 3 percent is less than the proposed threshold of at least 4
percent of expected expenditures for total potential risk proposed for
Advanced APMs in the Quality Payment Program proposed rule, those rural
hospitals, SCHs, MDHs, and RRCs that are EPM participants subject to
special protections would be in Track 2 EPMs that would not meet the
proposed nominal risk standard for Advanced
[[Page 50809]]
APMs for performance year 2. We recognize that this proposal might
initially limit the ability of rural hospitals, SCHs, MDHs, and RRCs to
be in Track 1 EPMs that are Advanced APMs. We believe this potential
limitation on rural hospitals, SCHs, MDHs, and RRCs is appropriate for
the following reasons: (1) Greater risk protections for these hospitals
proposed for the EPMs beginning in the second quarter of performance
year 2 and subsequent performance years compared to other EPM
participants are necessary, regardless of their implications regarding
Advanced APMs based on the nominal risk standard proposed in the
Quality Payment Program proposed rule, because these hospitals have
unique challenges that do not exist for most other hospitals, such as
being the only source of health care services for beneficiaries or
certain beneficiaries living in rural areas or being located in areas
with fewer providers, including fewer physicians and post-acute care
facilities; and (2) under the risk arrangements proposed for the EPMs,
these hospitals would not bear an amount of risk in performance year 2
that we determined to be more than nominal in the Quality Payment
Program proposed rule. However, we seek comment on whether we should
allow EPM participants that are rural hospitals, SCHs, MDHs, or RRCs to
elect a higher stop-loss limit for the part of performance year 2 where
downside risk applies in order to permit these hospitals to be in Track
1 EPMs for that part of performance year 2. We note that by performance
year 3, the stop-loss limit for these hospitals with special
protections under the EPMs would increase to 5 percent under our
proposal, so these hospitals could be in Track 1 EPMs based on the
nominal risk standard proposed in the Quality Payment Program proposed
rule.
As addressed in the Quality Payment Program proposed rule, it is
necessary for an APM to require the use of CEHRT in order to meet the
criteria to be considered to be an Advanced APM. Therefore, according
to the requirements proposed in the Quality Payment Program proposed
rule, so that the EPMs may meet the proposed criteria to be Advanced
APMs, we propose to require EPM participants to use CEHRT (as defined
in section 1848(o)(4) of the Act) to participate in Track 1 of the
EPMs. We propose that Track 1 EPM participants must use certified
health IT functions, in accordance with the definition of CEHRT under
our regulation at 42 CFR 414.1305, to document and communicate clinical
care with patients and other health care professionals as proposed in
the Quality Payment Program proposed rule (81 FR 28299). We believe
this proposal would allow Track 1 EPMs to be able to meet the proposed
criteria to be Advanced APMs.
Without the collection of identifying information on eligible
clinicians (physicians, nonphysician practitioners, physical and
occupational therapists, and qualified speech-language pathologists)
who would be considered Affiliated Practitioners as proposed in the
Quality Payment program proposed rule under the EPMs, CMS would not be
able to consider participation in the EPMs in making determinations as
to whom could be considered a QP (81 FR 28320). As detailed in the
Quality Payment Proposed rule, these determinations are based on
whether the eligible clinician meets the QP threshold under either the
Medicare Option starting in payment year 2019 or the All-Payer
Combination Option, which is available starting in payment year 2021
(81 FR 28165). Thus, we make proposals in the following sections to
specifically address these issues that might otherwise preclude the
EPMs from being considered Advanced APMs, or prevent us from
operationalizing them as Advanced APMs. Based on the proposals for
Advanced APM criteria in the Quality Payment Program proposed rule, we
seek to align the design of the proposed EPMs with the proposed
Advanced APM criteria and enable CMS to have the necessary information
on eligible clinicians to make the requisite QP determinations.
b. EPM Participant Tracks
To be considered an Advanced APM, the APM must require participants
to use CEHRT (as defined in section 1848(o)(4) of the Act), as
specified in section 1833(z)(3)(D)(i)(I) of the Act. We propose that
all EPM participants must choose whether to meet the CEHRT use
requirement. EPM participants that do not choose to meet and attest to
the CEHRT use requirement would be in Track 2 of the EPMs. EPM
participants selecting to meet the CEHRT use requirement would be in
Track 1 of the EPMs and would be required to attest in a form and
manner specified by CMS to their use of CEHRT that meets the definition
in our regulation at Sec. 414.1305 to document and communicate
clinical care with patients and other health professionals, consistent
with the proposal in the Quality Payment Program proposed rule for the
CEHRT requirement for Advanced APMs (81 FR 28299). EPM participants
choosing not to meet and attest to the CEHRT use requirement would not
be required to submit an attestation.
We believe that the selection by EPM participants to meet and
attest to the CEHRT use requirement would create no significant
additional administrative burden on EPM participants. Moreover, the
choice of whether to meet and attest to the CEHRT use requirement would
not otherwise change any EPM participant's requirements or opportunity
under the EPM. However, to the extent that eligible clinicians who
enter into financial arrangements related to Track 1 EPM participants
are considered to furnish services through an Advanced APM, those
services could be considered for purposes of determining whether the
eligible clinicians are QPs.
The proposals for CEHRT use and attestation for EPM participants
are included in Sec. 512.120(a). We seek comment on our proposals for
EPM participant CEHRT use requirements.
c. Clinician Financial Arrangements Lists Under the EPMs
In order for CMS to make determinations as to eligible clinicians
who could be considered QPs based on services furnished under the EPMs
(to the extent the models are determined to be Advanced APMs), we
require accurate information about eligible clinicians who enter into
financial arrangements under the Track 1 EPMs under which the
Affiliated Practitioners support the participants' cost or quality
goals as discussed in section III.I. of this proposed rule. We note
that eligible clinicians could be EPM collaborators engaged in sharing
arrangements with an EPM participant; PGP members who are collaboration
agents engaged in distribution arrangements with a PGP that is an EPM
collaborator; or PGP members who are downstream collaboration agents
engaged in downstream distribution arrangements with a PGP that is also
an ACO participant in an ACO that is an EPM collaborator. These terms
as they apply to individuals and entities with financial arrangements
under the EPMs are discussed in section III.I. of this proposed rule. A
list of physicians and nonphysician practitioners in one of these three
types of arrangements could be considered an Affiliated Practitioner
List of eligible clinicians who are affiliated with and support the
Advanced APM Entity in its participation in the Advanced APM as
proposed in the Quality Payment Program proposed rule. Therefore, this
list could be used to make determinations of who would be
[[Page 50810]]
considered for a QP determination based on services furnished under the
EPMs (81 FR 28320).
Thus, we propose that each EPM participant that chooses to meet and
attest to the CEHRT use requirement must submit to CMS a clinician
financial arrangements list in a form and manner specified by CMS on a
no more than quarterly basis. The list must include the following
information for the period of the EPM performance year specified by
CMS:
For each EPM collaborator who is a physician, nonphysician
practitioner, or provider of outpatient therapy services during the
period of the EPM performance year specified by CMS:
++ The name, tax identification number (TIN), and national provider
identifier (NPI) of the EPM collaborator.
++ The start date and, if applicable, end date, for the sharing
arrangement between the EPM participant and the EPM collaborator.
For each collaboration agent who is a physician or
nonphysician practitioner of a PGP that is an EPM collaborator during
the period of the EPM performance year specified by CMS:
++ The TIN of the PGP that is the EPM collaborator, and the name
and NPI of the physician or nonphysician practitioner.
++ The start date and, if applicable, end date, for the
distribution arrangement between the EPM collaborator that is a PGP and
the physician or nonphysician practitioner who is a PGP member.
For each downstream collaboration agent who is a physician
or nonphysician practitioner member of a PGP that is also an ACO
participant in an ACO that is an EPM collaborator during the period of
the EPM performance year specified by CMS:
++ The TIN of the PGP that is the ACO participant, and the name and
NPI of the physician or nonphysician practitioner.
++ The start date and, if applicable, end date, for the downstream
distribution arrangement between the collaboration agent that is both
PGP and an ACO participant and the physician or nonphysician
practitioner who is a PGP member.
If there are no individuals that meet the requirements to
be reported as EPM collaborators, collaboration agents, or downstream
collaboration agents, the EPM participant must attest in a form and
manner required by CMS that there are no individuals to report on the
clinician financial arrangements list.
As discussed in the Quality Payment program proposed rule, those
physicians or nonphysician practitioners who are included on the
Affiliated Practitioner List as of December 31 of a performance period
would be assessed to determine whether they qualify for APM Incentive
Payments (81 FR 28320).
While the required submission of this information may create some
additional administrative requirements for certain EPM participants, we
expect that Track 1 EPM participants could modify their contractual
relationships with their EPM collaborators and, correspondingly,
require those EPM collaborators to include similar requirements in
their contracts with collaboration agents and in the contracts of
collaboration agents with downstream collaboration agents.
The proposal for the submission of a clinician financial
arrangements list by EPM participants that meet and attest to the CEHRT
use requirement for the EPMs is included in Sec. 512.120(b). We seek
comments on the proposal for submission of this information. We are
especially interested in comments about approaches to information
submission, including the periodicity and method of submission to CMS
that would minimize the reporting burden on EPM participants while
providing CMS with sufficient information about eligible clinicians in
order to facilitate QP determinations to the extent EPMs are considered
Advanced APMs.
d. Documentation Requirements
For each EPM participant that chooses to meet and attest to CEHRT
use, we propose that the EPM participant must maintain documentation of
their attestation to CEHRT use and clinician financial arrangements
lists submitted to CMS. These documents would be necessary to assess
the completeness and accuracy of materials submitted by an EPM
participant in the Track 1 EPM and to facilitate monitoring and audits.
For the same reason, we further propose that the EPM participant must
retain and provide access to the required documentation in accordance
with Sec. 512.110.
The proposal for documentation of attestation to CEHRT use and
clinician financial arrangements lists submitted to CMS is included in
Sec. 512.120(c). We seek comment on this proposal for required
documentation.
3. Future Directions for Episode Payment Models
a. Refinements to the BPCI Initiative Models
The BPCI initiative Models 2, 3, and 4 would not currently qualify
as Advanced APMs based on the two of the Advanced APM criteria in the
Quality Payment Program proposed rule, payment based on quality
measures and CEHRT use (81 FR 28298). Specifically, BPCI participants
are not currently required to use CEHRT, and although CMS examines the
quality of episode care in the BPCI evaluation, BPCI episode payments
are not specifically tied to quality performance. Instead, BPCI episode
payments are based solely on episode spending performance, although we
expect that reductions in spending would generally be linked to
improved quality through reductions in hospital readmissions and
complications. However, building on the BPCI initiative, the Innovation
Center intends to implement a new voluntary bundled payment model for
CY 2018 where the model(s) would be designed to meet the criteria to be
an Advanced APM.
b. Potential Future Condition-Specific Episode Payment Models
In the context of our proposal for the AMI and CABG models that
include beneficiaries with CAD who experience an acute event or a major
surgical procedure, we seek comment on model design features for
potential future condition-specific episode payment models that could
focus on an acute event or procedure or longer-term care management,
including other models for beneficiaries with CAD that may differ from
the design of the EPMs proposed in this rulemaking. We believe such
future models may have the potential to be Advanced APMs that emphasize
outpatient care and, like the proposed AMI and CABG models, could
incentivize the alignment of physicians and other eligible
professionals participating in the Advanced APM through accountability
for the costs and quality of care. Such condition-specific episode
payment models may provide for a transition from hospital-led EPMs to
physician-led accountability for episode quality and costs, especially
given the importance of care management over long periods of time for
beneficiaries with many chronic conditions.
We request that commenters provide specific information regarding
all relevant issues for potential future condition-specific episode
payment models, including identifying beneficiaries for the model;
including services in the episode definition; beginning and ending
episodes; pricing episodes, including risk-adjustment; designating the
accountable entity for the quality and cost of the episode, including
the role of physician-led
[[Page 50811]]
opportunities; sharing of responsibility for quality and spending
between primary care providers, specialty physicians, and other health
care professionals; incentivizing the engagement of physicians and
other providers and suppliers in episode care; measuring quality and
including quality performance and improvement in the payment
methodology; interfacing with other CMS models and programs responsible
for population health and costs, such as ACOs and Primary Care Medical
Homes (PCMHs); and other considerations specific to identifying future
models as Advanced APMs; and any other issues of importance for the
design of such an EPM.
c. Potential Future Event-Based Episode Payment Models for Procedures
and Medical Conditions
Given the proposed EPM methodology discussed in section III.C.4.a.
of this proposed rule for the three models that would begin the
episodes with initial hospitalizations, the proposed AMI, CABG, and
SHFFT episodes are similar to the LEJR episodes in the CJR model
because they reflect clinical conditions for which care is almost
always begun during an inpatient hospitalization, either on an
emergency or elective basis. In addition, the clinical conditions
represented by these EPM episodes generally result in straightforward
assignment to MS-DRGs at discharge that are specific to clinical
conditions included in the episodes. This contrasts with procedure-
related clinical conditions for which the site-of-service can be
inpatient or outpatient (for example, elective PCI for non-AMI
beneficiaries) or hospitalization for medical conditions for which the
ultimate MS-DRG assigned is less clear at the beginning of an episode
(for example, hospitalization for respiratory symptoms which may lead
to discharge from heart failure, pneumonia, or other MS-DRGs based on
reporting of ICD-CM diagnosis codes on hospital claims).
To address the issues related to the development of future episode
payment models for a broader range of clinical conditions, we seek
comment on model design features that would be important for episode
payment models targeting procedures that may be performed in both the
inpatient and outpatient setting, as well as models focused on
hospitalization for acute medical conditions which may overlap or
interact (for example, sepsis related to pneumonia or acute kidney
injury related to congestive heart failure exacerbation). In
particular, episode payment models must clearly define the beginning of
the episode as well as set an episode price that is appropriate for
beneficiaries included in the episode, which has commonly been based on
historical spending for such beneficiaries in both existing CMS models
and the three proposed EPMs. These parameters pose specific challenges
as the variety of clinical conditions targeted for episode payments
expands beyond lower extremity orthopedic procedures and acute cardiac
conditions, and we expect that such potential future models would need
to be designed differently than the CJR model or the EPMs proposed in
this rulemaking.
For example, because procedures such as PCI for non-AMI
beneficiaries or cardioverter defibrillator implantations can occur in
the inpatient or outpatient setting, an episode payment model would
need to include beneficiaries receiving such procedures at all sites-
of-service so as to not influence decisions on where procedures are
performed based on payment-related rather than clinical considerations.
Episode payment models that begin with the same procedure performed in
the inpatient or outpatient setting would require methodological
development beyond the approaches that have been used thus far in CMS's
other EPMs that rely upon the MS-DRG for a hospitalization to begin an
episode and identify historical episodes for setting episode prices.
Such models that involve episode payment for procedures furnished in
the inpatient or outpatient setting may allow for significant
physician-led opportunities that would allow the models to be
identified as Advanced APMs. We seek comment on how these types of
procedures could be included in future episode payment models,
including identifying the accountable entity, and the role of
physician-led opportunities; defining the episode beginning and end;
setting episode prices; applying risk-adjustment to account for
differences in expected episode spending for a heterogeneous population
of beneficiaries; and any other issues of importance for the design of
such an episode payment model.
We also seek comment on potential future episode payment models
that would include care for medical conditions that result in the
serious health event of an inpatient hospitalization, which often
represents, regardless of the specific reason for the hospitalization,
a common pathway that includes failure of outpatient care management
and care coordination for beneficiaries with chronic conditions. While
we do include in the proposed AMI model beneficiaries who solely
receive medical treatment, we note that beneficiaries with AMI are
almost always hospitalized and their MS-DRGs at discharge are generally
predictable and consistent based on their AMI diagnoses. This is not
the case for a number of medical conditions for which grouping by MS-
DRGs is more complicated or less consistent. Many non-procedural
hospitalizations of Medicare beneficiaries are ultimately categorized
based on the principal ICD-CM diagnosis code reported on a claim, which
in turn is mapped to a Major Diagnostic Category (MDC) based on the
involved organ system, which then leads to the assignment of any of
various specific MS-DRGs based on the medical groups in the MDC. For
example, the medical groups for the Respiratory System MDC are
pulmonary embolism, infections, neoplasms, chest trauma, pleural
effusion, pulmonary edema and respiratory failure, chronic obstructive
pulmonary disease, simple pneumonia, RSV pneumonia and whooping cough,
interstitial lung disease, pneumothorax, bronchitis and asthma,
respiratory symptoms and other respiratory diagnoses.\34\ Unlike a
beneficiary who undergoes a surgical procedure or who is hospitalized
for a specific medical condition such as AMI, the ultimate MS-DRG at
discharge assigned to a beneficiary hospitalized for diagnosis and
management of respiratory symptoms may not be clear during the
hospitalization itself, or even afterward, until the inpatient claim is
submitted and paid by Medicare. This makes it challenging for providers
to engage in care delivery redesign targeted to a specific patient
population identified by MS-DRG. Additionally, it is possible that
beneficiaries hospitalized for certain medical conditions also may
follow common clinical pathways before and after discharge for which
similar care redesign strategies could be developed and used despite
those beneficiaries' assignments to different MS-DRGs for their anchor
hospitalizations. Thus, we believe that hospitalization for most
medical conditions would require special consideration in the
development of potential future episode payment models that goes beyond
CMS's current approach of relying upon the MS-DRG for the anchor
hospitalization to begin an episode and identify historical episodes
for setting episode prices. We seek comment on design features needed
to address these considerations, including defining the beginning and
end of episodes; setting episode prices,
[[Page 50812]]
including risk-adjustment, that would support the provision of
appropriate and coordinated care for beneficiaries following hospital
discharge for a period of time during the episode; and any other issues
of importance for the design of such an episode payment model.
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\34\ Medical Severity Diagnosis Related Groups (MS-DRGs):
Definitions Manual. Version 33.0A. 3M Health Information Systems.
(October 1, 2015).
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d. Health Information Technology Readiness for Potential Future Episode
Payment Models
We are particularly interested in issues related to readiness of
providers and suppliers that are not hospitals to take on financial
responsibility for episode cost and quality in potential future episode
payment models. We have some experience in BPCI Models 2 and 3 with
non-hospital providers and suppliers, specifically post-acute care
providers and physician group practices (PGPs), who assume financial
responsibility for the cost of episode care. In BPCI Model 2, PGPs may
directly bear financial responsibility for episode cost for up to 48
clinical conditions for the anchor inpatient admission and up to 90
days post-hospital discharge. In BPCI Model 3, PGPs and post-acute care
providers, including skilled nursing facilities, home health agencies,
inpatient rehabilitation facilities, and long-term care hospitals, may
directly bear financial responsibility for episode cost for up to 48
clinical conditions for a duration that extends up to 90 days following
initiation of post-acute care following discharge from an inpatient
hospitalization.
Under these circumstances, PGPs and post-acute care providers
typically need to use health IT to assist them in effectively
coordinating the care of BPCI beneficiaries across settings throughout
the episodes. The risk-bearing entities participating in BPCI have
expressed readiness to take on financial responsibility for episode
cost, and they commonly rely upon health IT for assistance in managing
the care for BPCI beneficiaries across settings for episodes that
extend for a substantial period of time. However, a recent national
survey of IT in nursing homes showed common use of IT for
administrative activities but less use for clinical care.\35\
Anecdotally, stakeholders have told us that accountable non-hospital
providers and suppliers, especially those that are not integrated with
health systems, may have less well-developed tools for following
patients throughout episodes, potentially resulting in greater
challenges in reducing the cost and improving the quality of episode
care under the BPCI models. Therefore, we understand that limitations
in the availability of health IT that can be used in beneficiary
management across care settings may pose a significant barrier to the
readiness of non-hospital providers and suppliers to assume financial
responsibility for episodes in potential future episode payment models.
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\35\ Alexander Gregory L. ``An Analysis of Nursing Home Quality
Measures and Staffing.'' Quality management in health care 17.3
(2008): 242-251. PMC. Web. 16 July 2016.
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In the CJR model, acute care hospitals are financially responsible
for cost and quality during LEJR episodes-of-care. CJR model
participant hospitals may form partnerships with post-acute care
providers such as skilled nursing facilities and home health agencies,
as well as physicians and PGPs, to share financial risk and collaborate
on care redesign strategies, as in BPCI. Although hospitals are the
financially responsible entities under the CJR model, we recognize that
partnerships with post-acute care providers could be a crucial driver
of episode spending and quality, given that many beneficiaries in the
CJR model receive post-acute care services after discharge from the
hospital. We also recognize that tools such as health IT may be
critical for certain care management and quality strategies targeted
toward the goal of lower cost and higher quality episode care.
Limitations in the availability of health IT may pose a barrier to
effective post-acute care provider collaboration and sharing of
financial risk in episode payment models even when hospitals are the
financially responsible entities under such models, such as the CJR
model and the three new EPMs proposed in this rulemaking.
We recognize that there is wide variation in the readiness of other
providers and suppliers to bear financial responsibility for episodes,
either directly or indirectly through sharing arrangements with the
directly responsible entities where those arrangements may include
upside and downside risk. For instance, adoption of health IT among
providers in the post-acute care market, such as skilled nursing
facilities, continues to lag behind hospitals and providers of
ambulatory care services. In addition to facing significant resource
constraints, post-acute care providers were not included as an eligible
provider type under the Medicare and Medicaid Electronic Health Record
(EHR) Incentive Programs. The recent extension of Medicaid 90/10
funding offers new opportunities for states to include post-acute care
providers in projects focused on infrastructure development, but will
not address the cost of health IT adoption among post-acute care
providers.\36\
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\36\ https://www.medicaid.gov/federal-policy-guidance/downloads/SMD16003.pdf.
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To ensure that post-acute care providers and other types of
providers and suppliers can succeed under future episode payment
models, either as the directly financially responsible entity or as
collaborators with other directly financially responsible entities, we
are interested in opportunities to increase provider readiness as part
of the design of potential future episode payment models and the
potential refinement of current episode payment models. Specifically,
we would like to explore: Incentives to encourage post-acute care
providers, as well as other providers and suppliers that furnish
services to episode payment model beneficiaries, to make necessary
investments in health IT infrastructure; payment mechanisms that could
leverage savings achieved under episode payment models to contribute to
these investments; and any other strategies to enhance the adoption,
implementation, and upgrading of certified health IT. We seek comment
on these ideas, as well as the following questions:
What are key challenges associated with the inclusion of
post-acute care providers as the financially responsible entity or as
collaborators with other financially responsible entities in episode
payment models today?
What would be a sufficient financial incentive or bonus to
enhance the adoption, implementation, and upgrading of certified health
IT in post-acute care settings?
How else can episode payment models encourage the use of
certified health IT and information sharing among providers and
suppliers caring for episode payment model beneficiaries to improve
care coordination and patient outcomes?
Within the existing CJR model, are there additional
opportunities to encourage investment in adoption, implementation, and
upgrading of certified health IT among post-acute care providers to
support improvements in care coordination and patient outcomes? What
CJR model refinements could enable direct investments to support these
improvements, particularly among post-acute care providers who are
unaffiliated with CJR model participant hospitals but who provide
services to CJR model beneficiaries, including post-acute care
providers who may enter into financial arrangements with CJR model
participant hospitals as CJR collaborators?
[[Page 50813]]
B. Proposed Definition of the Episode Initiator and Selected Geographic
Areas
1. Background
The proposed new EPMs will complement the current CJR model and
continue efforts to move Medicare towards paying providers based on
quality and value. As discussed during rulemaking for the CJR model,
CMS is interested in testing and evaluating the impact of an episode
payment approach for a broad range of episodes in a variety of other
circumstances. In addition to including hospitals that have not chosen
to voluntarily participate in earlier models, we also are interested in
expanding the range of episodes included beyond elective surgical
procedures such that the impact on a broader range of beneficiaries,
hospitals, and circumstances may be tested. We also are interested in
evaluating the impact on hospitals when an increasing percentage of
care to Medicare beneficiaries is paid for through alternative payment
models.
As with CJR, we propose in Sec. 512.105(c) that the hospital be
the accountable financial entity and that these episode payment models
be implemented in all IPPS hospitals in the geographic areas selected,
subject to exclusions as specified in Sec. Sec. 512.230 and 512.240 of
the proposed rule. While these are considered new episode payment
models and do not reflect an expansion or extension of any previous
models, they do intentionally build significantly upon the work of BPCI
and, most significantly, the framework established for CJR under 42 CFR
part 510 published on November 24, 2015. Given the extensive
consideration given to many of these issues during the CJR model
planning and rulemaking periods, we believe this is important as we
seek to build a model that is scalable across all providers and episode
types. We also seek to limit the burden for hospitals and other
providers that may be participating across multiple episode types.
Therefore, to the extent applicable and appropriate, we have sought
consistency with rules established for the CJR model. We seek comment
on those areas where alternative options are proposed or should be
considered that would not add additional operational burden or
complexity.
2. Proposed Definition of Episode Initiator
Under the proposed EPMs, we propose, consistent with our definition
under the CJR model that episodes would begin with the admission to an
IPPS acute-care hospital that triggers an AMI, CABG or SHFFT episode as
specified in section III.C.4.a. of this proposed rule. As with the CJR
model, we propose that hospitals would be the only episode initiators
in these episode payment models. For purposes of these episodes payment
models the term ''hospital'' means a hospital as defined in section
1886(d)(1)(B) of the Act. This statutory definition of hospital
includes only acute care hospitals paid under the IPPS. Under this
proposal, all acute care hospitals in Maryland would be excluded and
payments to Maryland hospitals would be excluded in the regional
pricing calculations as described in section III.D.4. of this proposed
rule. This is the same policy that is being followed with the CJR
model. In addition, we also propose to exclude other all-payer state
models which may be implemented in the future. We welcome comments on
this proposal and whether there are potential approaches for including
Maryland acute-care hospitals or, potentially, other hospitals in
future all-payer state models in these episode payment models.
As implemented with the CJR model, we propose to designate IPPS
hospitals as the episode initiators to ensure that all services covered
under FFS Medicare and furnished by EPM participant hospitals in
selected geographic areas to beneficiaries who do not meet the
exclusion criteria specified in section III.C.4. of this proposed rule
are included. In addition, the episodes must not be BPCI episodes that
we are proposing to exclude as outlined in this section and in section
III.C.4. of this proposed rule. We believe that utilizing the hospital
as the episode initiator is a straightforward approach for these models
because patients covered under these DRGs and diagnoses require
hospital admission for these services, whether provided on an emergent
or planned basis. Under these new models covering medical admissions
and services that are not necessarily elective, we will be able to
expand our testing of a more generalized bundled payment model.
Finally, as described in section III.B.4., our proposed geographic area
selection approach relies upon our definition of hospitals as the
entities that initiate episodes.
3. Financial Responsibility for the Episode of Care
As with the CJR model, we continue to believe it is most
appropriate to identify a single type of provider to bear financial
responsibility for making repayment, if any, to CMS under the model and
propose to make hospitals, as the episode initiators, financially
responsible for the episode of care for the following several reasons:
Hospitals play a central role in coordinating episode-
related care and ensuring smooth transitions for beneficiaries
undergoing services related to SHFFT, AMI and CABG episodes. A large
portion of a beneficiary's recovery trajectory from an AMI, CABG, or
SHFFT begins during the hospital stay.
Most hospitals already have some infrastructure related to
health information technology, patient and family education, and care
management and discharge planning. This includes post-acute care
coordination infrastructure and resources such as case managers, which
hospitals can build upon to achieve efficiencies under these EPMs.
By definition, these episodes always begin with an acute
care hospital stay. While often preceded by an emergency room visit and
possible transfer from another hospital's emergency room, or followed
by post-acute care, these parties are not necessarily always present
and would not be appropriate to target as the financially responsible
party for this purpose.
EPM episodes may be associated with multiple hospitalizations
through transfers. When multiple hospitalizations occur, we propose
that the financial responsibility be given to the hospital to which the
episode is attributed as described in section III.C.4. We recognize
that, particularly where the admission may be preceded by an emergency
room visit and subsequent transfer to a tertiary or other regional
hospital facility, patients often wish to return home to their local
area for post-acute care. Many hospitals have recently heightened their
focus on aligning their efforts with those of community providers, both
those in the immediate area as well as more outlying areas from which
they receive transfers and referrals, to provide an improved continuum
of care. In many cases, this is due to the incentives under other CMS
models and programs, including ACO initiatives such as the Shared
Savings Program, the Hospital Readmissions Reduction Program (HRRP),
and the CJR model. By focusing on the hospital as the accountable or
financially responsible entity, we hope to continue to encourage this
coordination across providers and seek comment on ways we can best
encourage these relationships within the scope of these EPMs.
In support of our proposal that hospitals be the episode initiators
under these EPMs, we believe that hospitals
[[Page 50814]]
are more likely than other providers to have an adequate number of
episode cases to justify an investment in episode management for these
EPMs. We also believe that hospitals are most likely to have access to
resources that would allow them to appropriately manage and coordinate
care throughout these episodes. Finally, the hospital staff is already
involved in discharge planning and placement recommendations for
Medicare beneficiaries, and more efficient post-acute care service
delivery provides substantial opportunities for improving quality and
reducing costs under EPMs. For those hospitals that are already
participating in CJR, we believe the efforts that have been put in
place to support patients receiving LEJR will be supportive of the new
EPMs proposed under this rule, particularly for SHFFT episodes which we
propose to implement in the same geographic areas as the CJR model.
Finally, as noted when planning for the CJR model, although the
BPCI initiative includes the possibility of a physician group practice
as a type of episode initiating participant, the physician groups
electing to participate in BPCI have done so because their practice
structure supports care redesign and other infrastructure necessary to
bear financial responsibility for episodes. These physician groups are
not necessarily representative of the typical group practice. As with
the CJR model, the infrastructure necessary to accept financial
responsibility for episodes is not present across all physician group
practices, and thus we do not believe it would be appropriate to
designate physician group practices to bear the financial
responsibility for making repayments to CMS under the proposed EPMs. We
seek comment on our proposal to establish financial responsibility and
accountability under the AMI, CABG, and SHFFT EPMs consistent with our
implementation of the CJR model.
Currently, there are SHFFT, AMI, and CABG episodes being tested in
BPCI Models 2, 3 or 4. The last remaining BPCI Model 1 hospital will
end December 31, 2016 and will, therefore, not overlap with EPM. In
addition, under BPCI, there are episodes for PCI, which, if an AMI were
also involved, would fall under the AMI model being proposed here. We
are proposing that IPPS hospitals located in an area selected for any
one of the episode payment models proposed in this rule that also are
episode initiators for episodes in the risk-bearing phase of BPCI
Models 2 or 4, be excluded from participating in the AMI, CABG, or
SHFFT EPMs if the applicable episode otherwise would qualify to be
covered under BPCI. This exclusion would be in effect only during the
time that the relevant qualifying episodes are included in one of the
BPCI models. Likewise, we are proposing that if the EPM participant is
not an episode initiator for overlapping episodes under BPCI Models 2
or 4, but these same episodes are initiated during the anchor
hospitalization by a physician group practice (PGP) under BPCI Model 2
(where the services are provided at the episode initiating hospital)
then the episode also shall be covered under BPCI and be excluded from
the EPMs being proposed under this rule. Otherwise qualifying EPM
episodes (that is, those that are not part of an overlapping BPCI AMI,
CABG, PCI or SHFFT episode) at the participant hospital would be
included in these new EPMs. However, because BPCI participation is
voluntary and participating providers may select which episodes to
participate in, a BPCI participating provider will participate in any
of the proposed AMI, CABG, or SHFFT EPMs for any episodes not otherwise
preempted under their BPCI participation. For example, a BPCI Model 2
hospital in an AMI episode model geographic area participating in BPCI
only for CABGs will be an EPM participant in the AMI model. Similarly,
an acute care hospital participating in BPCI for LEJR but not SHFFT
episodes would be exempt from participation in the CJR model in a CJR
model geographic area but would participate in the SHFFT model for
SHFFT episodes. In addition, providers participating in BPCI may also
collaborate with an EPM participant for episodes not covered under
BPCI. It should be noted that due to differences in how the AMI episode
is defined under the AMI model versus BPCI and the inclusion of PCI MS-
DRGs under the latter, a patient with the same discharge MS-DRG and
diagnoses may qualify for a PCI episode under BPCI and an AMI episode
under the AMI model. Our intent is to give precedence to BPCI
regardless of which episode a patient qualifies for if the patient
would be covered under BPCI.
In section III.D.6. we discuss in more detail how we propose to
handle situations when a beneficiary receives services that would
qualify for inclusion in more than one CMS payment model during the
same or overlapping periods of time. We welcome input on how these
overlaps should be handled to best encourage ongoing care coordination
while minimizing the impact on other models and limiting confusion and
operational burden for providers.
While we propose that the EPM participant be financially
responsible for the episode of care under these EPMs, we also believe
that effective care redesign requires meaningful collaboration among
acute care hospitals, post-acute care providers, physicians, and other
providers and suppliers within communities to achieve the highest value
care for Medicare beneficiaries. We believe it may be essential for key
providers to be aligned and engaged, financially and otherwise, with
the EPM participants, with the potential to share financial
responsibility with those EPM participants. We note that all
relationships between and among providers and suppliers must comply
with all relevant laws and regulations, including the fraud and abuse
laws and all Medicare payment and coverage requirements unless
otherwise specified further in this section and in sections III.I. and
III.J. of this proposed rule. Depending on a hospital's current degree
of clinical integration, new and different contractual relationships
among hospitals and other health care providers may be important,
although not necessarily required, for EPM success in a community. We
acknowledge that financial incentives for other providers may be
important aspects of the model in order for EPM participants to partner
with these providers and incentivize certain strategies to improve
episode efficiency.
While we acknowledge the important role of conveners in the BPCI
model, and AMI, CABG, and SHFFT model participants may wish to enter
into relationships with EPM collaborators and other entities in order
to manage the episode of care or distribute risk, we propose that the
ultimate financial responsibility of the episode remains with the EPM
participant. Exceptions to this general rule for beneficiaries covered
under certain risk bearing ACO arrangements are outlined in section
III.D.6. As with the CJR model, we do not intend to restrict the
ability of EPM participants to enter into administrative or risk
sharing arrangements related to these EPMs, except to the extent that
such arrangements are already restricted or prohibited by existing law.
We refer readers to section III.I. of this proposed rule for further
discussion of model design elements that may outline financial
arrangements between EPM participants and other providers and
suppliers.
[[Page 50815]]
4. Proposed Geographic Unit of Selection and Exclusion of Selected
Hospitals
In order to determine the geographic unit of selection for these
episode payment models, we conducted an analysis similar to that used
for the CJR model. For the CJR model, we considered using a stratified
random sampling methodology to select: (1) Certain counties based on
their Core-Based Statistical Area (CBSA) status; (2) certain zip codes
based on their Hospital Referral Regions (HRR) status or (3) certain
states. We concluded that selection based on MSAs provided the best
balance between choosing smaller geographic units while still capturing
the impact of market patterns reflecting the mobility of patients and
providers and limiting the potential risk for patient shifting and
steerage between MSAs. HRRs are based on where patients receive
selected tertiary care services which do not include orthopedic
services. Therefore, HRRs may not be representative of where patients
receive specialty orthopedic care or more routine orthopedic services
such as hip and knee arthroplasty. Selection of states rather than MSAs
would have greatly reduced the number of independent geographic areas
subject to selection and, therefore, the statistical power of the
evaluation. For similar reasons and to maintain consistency with the
CJR model, we are, similarly, recommending implementation at the MSA
level.
We also similarly considered whether these new models should be
limited to hospitals where a high volume of these episodes occur, which
would result in a more narrow test on the effects of an episode-based
payment, or whether to include all hospitals in particular geographic
areas, which would result in testing the effects of an episode-based
payment approach more broadly across an accountable care community
seeking to coordinate care longitudinally across settings. However, as
with the CJR model, there would be more potential for behavioral
changes that could include patient shifting and steering between
hospitals in a given geographic area that could impact the test.
Additionally, this approach would provide less information on testing
payments for these episodes across a wide variety of hospitals with
different characteristics. Selecting geographic areas and including all
IPPS hospitals in those areas not otherwise excluded due to BPCI
overlap as previously described and in section III.D.6. of this
proposed rule as model participants would help to minimize the risk of
participant hospitals shifting higher cost cases out of the EPM.
In determining where to implement these EPMs, we also considered
whether implementation of the CJR model in the same geographic area
should be a factor. We realize that there is likely to be considerable
overlap in the selection criteria between MSAs where the SHFFT EPM
might be appropriate and those MSAs where the CJR model is now being
implemented. While limiting burden on hospitals is an important
consideration, we also believe that the infrastructure being put in
place as a result of the CJR model presents significant advantages for
implementation of the SHFFT model. For similar reasons, and in order to
minimize patient steerage and/or transfer for reasons due solely to the
implementation of these new payment models, we believe that it is
appropriate to implement the AMI model and CABG model together in the
same geographic areas, albeit not necessarily in the same areas as the
CJR model.
Therefore, given the authority in section 1115A(a)(5) of the Act,
which allows the Secretary to elect to limit testing of a model to
certain geographic areas, we propose that the SHFFT model be
implemented in those MSAs where the CJR model is being implemented. We
also are proposing that the AMI and CABG models be implemented in MSAs
selected independently based on the criteria discussed in this proposed
rule. This will result in four separate categories of MSAs: (1) MSAs
where only the CJR and SHFFT model episodes are being implemented; (2)
MSAs where only the CABG model and AMI model episodes are being
implemented; (3) MSAs where the CJR as well as the AMI, CABG, and SHFFT
models are being implemented; and (4) MSAs where neither CJR nor any of
the new episode payment models are being implemented. We believe this
will provide an opportunity to test the impact of implementing EPMs
across not only a greater diversity of episodes but also as an
increasing percentage of hospital discharges. We seek comment on our
proposal to implement the SHFFT model in the same geographic region as
the CJR model and to implement both the AMI model and the CABG model in
the same MSAs, some of which may overlap with MSAs where the CJR and
SHFFT models also are being implemented.
5. Overview and Options for Geographic Area Selection for AMI and CABG
Episodes
We propose that the AMI and CABG EPMs be implemented together in
the same MSAs. These AMI/CABG-participating MSAs may or may not also be
LEJR/SHFFT-participating MSAs. The selection of MSAs for AMI/CABG EPMs
would occur through a random selection of eligible MSAs.
We propose to require participation in the AMI and CABG models of
all hospitals, with limited exceptions as previously discussed in
section III.B.4. of this proposed rule, paid under the IPPS that are
physically located in a county in an MSA selected through the
methodology outlined in section III.B.5.b. in this proposed rule, to
test and evaluate the effects of an episode-based payment approach for
the proposed EPMs. We propose to determine that a hospital is located
in an area selected if the hospital is physically located within the
boundary of any of the counties in that MSA as of the date the
selection is made.
Although MSAs are revised periodically, with counties added or
removed from certain MSAs, we propose to maintain the same cohort of
selected hospitals throughout the 5-year performance periods of the
EPMs with limited exceptions as described later in this section. Thus,
we propose neither to add hospitals to an EPM if after the start of
such EPM new counties are added to one of the selected MSAs nor to
remove hospitals from an EPM if counties are removed from one of the
selected MSAs. We believe that this approach will best maintain the
consistency of the participants in the EPMs, which is crucial for our
ability to evaluate their respective results. However, we retain the
possibility of adding a hospital that is opened or incorporated within
one of the selected counties after the selection is made and during the
period of performance. (See section III.D. of this proposed rule for
discussion of how target prices will be determined for such hospitals.)
The manner in which CMS tracks and identifies hospitals is through
the CMS Certification Number (CCN). In keeping with this approach,
these EPMs will administer model related activities at the CCN level
including the determination of physical location. The physical location
associated with the CCN at the time of an EPM's start will be used to
determine whether that CCN is located in a selected MSA. For hospitals
that share a CCN across various locations, all hospitals under that CCN
would be required to participate in the applicable EPM if the physical
address associated with the CCN is in the MSA selected, unless
otherwise excluded. Similarly, all hospitals under the same CCN, even
if some are physically located in the MSA
[[Page 50816]]
selected for participation, would not participate in the applicable EPM
if the physical address associated with the CCN is not in the MSA.
We considered including hospitals in a given MSA based on whether
the hospitals were classified into the MSA for IPPS wage index
purposes. However, such a process would be more complicated, and we
could not find any compelling reasons favoring such approach. For
example, we could assign hospitals to metro divisions of MSAs when
those divisions exist. In addition, there is the IPPS process of
geographic reclassification by which a hospital's payments can be based
on a geographic area other than the one where the hospital is
physically located. For the purpose of the EPMs, it is simpler and more
straightforward to use a hospital's physical location as the basis of
its assignment to a geographic unit. This decision would have no impact
on a hospital's payment under the IPPS. We seek comment on our proposal
to include a hospital as an EPM participant based on the physical
location associated with the CCN of the hospital in one of the counties
included in a selected MSA.
a. Exclusion of Certain MSAs
We considered whether certain MSAs should be exempt from the
possibility of selection for the AMI/CABG EPMs' implementation. We
considered exclusions based on the anticipated number of AMI episodes
and CABG episodes in the MSA. We also considered exclusions based on
the degree to which such EPMs' episodes would be impacted by overlaps
with other payment initiatives, including BPCI and ACOs.
First, we considered the advisability of MSA exclusions based on
the number of episodes in a year. We identified qualifying AMI and CABG
episodes that initiated between January 1, 2014, and December 31, 2014.
AMI and CABG episodes were attributed to an MSA based on the location
of the CCN associated with the initiating hospital using the Provider
of Service file. Due to the smaller number of relevant AMI and CABG
episodes occurring in MSAs, an exclusion rule that required a large
number of episodes in each MSA would result in fewer MSAs eligible for
selection than was necessary given the desired number of MSAs and the
requirement that to have 50 percent or more of MSAs remain in a pool of
possible comparison MSAs. From the perspective of evaluating changes to
utilization and spending under EPMs, there is no analytic need to
eliminate MSAs with small numbers. In fact, including smaller MSAs has
the analytic advantage of giving CMS more experience operating EPMs in
the smaller-MSA contexts that will help us generalize our EPM-
evaluation findings.
We have a strong interest in being able to observe how well EPMs
operate in areas with a lower volume of episodes, and, in particular,
the consequences of the model for AMI episodes where CABG is not
commonly performed or where standard practice is to refer all CABGs
outside of the MSA. Given our desire to assess the operation of the AMI
EPM in areas with little or no CABG episodes and the desire to have the
two cardiac EPMs be administered together in the same MSAs, we propose
that the MSA exclusion rules be based on the number of AMI episodes
only. This will allow for the inclusion of MSAs with no CABGs.
There is no analytic requirement for a minimum number of cases and
there are advantages to including smaller cities. At the same time, we
acknowledge that areas with few AMI cases may believe that they will
face challenges under the EPMs. Therefore, we propose an exclusion rule
that MSAs with fewer than 75 AMI episodes (determined as discussed in
section III.C. of this proposed rule) will be removed from the
possibility of selection. Cases in hospitals paid under either the CAH
methodology or the Maryland All-Payer Model are not included in the
count of eligible episodes. We examined a number of different minimum-
episode-number cutoffs. The use of the 75 AMIs in a year was a designed
to balance limiting the impact of outlier cases on the MSA average
episode spending and the desire to retain a non-negligible
representation of MSAs in the under 100,000 population and the 100,000
to 200,000 population ranges in our selection pool. The application of
Exclusion Rule 1: ``less than 75 qualifying AMI episodes in the
reference year'' resulted in the removal of 49 MSAs from possible
selection.
Second, we assessed exclusion rules based on overlap with BPCI. We
propose Exclusion Rule 2 such that MSAs are removed from possible
selection if there were fewer than 75 non-BPCI AMI episodes in the MSA
in the reference year. For the purposes of this exclusion, the number
of non-BPCI episodes was estimated by subtracting BPCI cases from the
total number of cases used in Exclusion Rule 1. BPCI cases for this
purpose are ones during the reference year associated with a hospital
or a PGP BPCI Model 2 or 4 episode initiator participating in an AMI,
PCI, or CABG episode as of January 1, 2016. Such criterion removed an
additional 26 MSAs from potential selection.
Third, we propose to exclude MSAs from possible selection based on
whether the number of non-BPCI AMI episodes calculated under Exclusion
Rule 2 is less than 50 percent of the total number of AMI episodes
calculated under Exclusion Rule 1. We anticipate that some degree of
overlap in the BPCI and other EPMs will be mutually helpful. However,
we acknowledge that some providers may have concerns that a BPCI Model
2 AMI and PCI participation rate of more than 50 percent may impair the
ability of participants in either the EPMs or the BPCI models to
succeed in the objectives of the initiative. As a result of this third
criterion, 13 additional MSAs were removed from possible selection.
We considered whether there should be an exclusion rule based on
the anticipated degree of overlap between the AMI and CABG EPMs and
patients who are aligned prospectively to ACOs that are taking two-
sided risk, such as ACOs participating in the Next Generation ACO model
or Track 3 of the Shared Savings Program. We examined numbers
associated with ACOs meeting this status as of May 1, 2016, and this
examination did not result in any additional MSAs falling below the 75
AMI episodes threshold. Consequently, we are not proposing any MSA
exclusion rule based on the presence of ACOs.
Please refer to Table 1 for the status of each MSA based on these
exclusion criteria, available at http://innovation.cms.gov/initiatives/epm. After applying these three exclusions, 294 MSAs out of 384 total
MSAs are eligible for selection using our proposed selection
methodology.
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BILLING CODE 4120-01-C
b. Proposed Selection Approach
We propose the selection of 98 MSAs through the use of simple
random selection from the 294 eligible MSAs.
Simple random selection is often considered to be an appropriate
default approach to experimental design unless there is a compelling
reason to depart from it. One common alternative approach is to perform
random selection separately within subgroups. Selection within
subgroups can be a useful approach to limiting differences between
intervention and control groups to improve statistical power or for
facilitating over or under sampling to allow the evaluation to examine
effects of the intervention on particular types of MSAs or because
those types of MSAs are of particular interest for policy reasons.
In CJR, we used a stratified random assignment approach in which we
organized MSAs into strata based on MSA population size and historic
LEJR episode payments. Under the CJR model, we believed a stratified
approach was appropriate due to wide regional variation in prices,
primarily associated with the use of post-acute services. The
stratified approach served as a means to oversample in higher-expense
MSAs as these areas have both the most need for and the most
opportunity under the CJR model.
In assessing whether stratification would be proposed for the EPMs,
we assessed a variety of factors described later in this section.
Absent stratification, the rate at which a particular type of MSA will
appear in the sample will be proportional to how often in appears among
eligible MSAs. If a particular type of MSA is relatively common, it is
likely to occur often enough that we do not need to deliberately over-
sample for it. In the end, our analyses did not provide sufficient
evidence that it is necessary to create selection subgroups of MSAs to
guide the selection approach. As a result, we are proposing to use
simple random selection from the entire pool of eligible MSAs.
(1) Factors Considered but Not Used
We considered a variety of possible MSA characteristics for
possible use in classifying sub-groups. Though we did consider many of
these variables important, we believe that a simple random selection,
where warranted, is preferable.
Some of the factors we considered that we are not proposing to use
in the selection methodology include the following:
Measures associated with AMI-episode and CABG episode
wage-adjusted spending, respectively. In considering how to
operationalize such measures, we considered a number of alternatives
including average total episode spending payments in an MSA, average
episode spending associated with the initial hospital stay(s) and
average episode spending occurring in the period after discharge from
the initial hospital.
Measures associated with variation in practice patterns
associated with AMI and CABG episodes. In considering how to
operationalize this measure, we considered a number of alternatives
including the extent to which both an AMI and a CABG episode are
associated with having a transfer hospital stay at the beginning of the
episode, and the extent to which CABG hospitalizations occur following
a hospital transfer from either within or from outside the same MSA.
Measures associated with relative market share of
providers with respect to AMI and/or CABG episodes, including the
presence or absence of regional referral centers and the number of
providers with the capacity to perform CABGs or otherwise treat complex
cardiac patients.
Health care supply measures of providers in the MSA
including acute or post-acute bed counts, and number of relevant
physician specialties such as cardiologists and cardiothoracic
surgeons.
MSA-level demographic measures such as: (1) average
income; (2) distributions of population by age, gender or race; (3)
percent dually eligible; and (4) percent with specific health
conditions or other demographic composition measures.
Measures associated with the degree to which a market
might be more capable or ready to implement care-redesign activities.
Examples of market-level characteristics that might be associated with
anticipated ease of implementation include the MSA-level EHR
meaningful-use levels, managed-care penetration, ACO penetration, and
experience with other bundling efforts.
Though these measures are not proposed to be part of the selection
process, we acknowledge that these and other market-level factors may
be important to the proper understanding of the evaluation of the
impact of EPMs. We intend to consider these and other measures in
determining which MSAs are appropriate comparison markets for the
evaluation and for possible subgroup analysis or risk-adjustment
purposes. The evaluations will include beneficiary-, provider-, and
market-level characteristics in how they will examine the performance
of these proposed EPMs.
(2) Sample-Size Calculations and the Number of Selected MSAs
Our analyses of the necessary sample size led us to propose the
selection of 98 MSAs, out of the 294 MSAs eligible
[[Page 50828]]
for selection and 384 total MSAs, to participate in both the AMI and
CABG EPMs. In this section, we discuss the assumptions and modeling
that went into our proposal to test these EPMs in 98 MSAs. The
discussion of the method of selection of these 98 MSAs is addressed in
the following section. In coming to the decision to target 98 MSAs, we
are proposing an approach that limits the size of the intervention to
the greatest degree possible, while still ensuring that we have
sufficient statistical power to reliably evaluate the effects of the
EPMs. Going below this threshold would jeopardize our ability to be
confident in our results and to be able to generalize from the EPMs to
the larger national context.
In calculating the necessary size of the AMI and CABG EPMs, a key
consideration was to have sufficient power to be able to detect the
desired size impact. The larger the anticipated size of the impact, the
fewer MSAs we would have to sample in order to observe it. However, a
model sized to be able to only detect large impacts runs the risk of
not being able to draw conclusions if the size of the change is less
than anticipated. The measure of interest used in estimating sample
size requirements for the both the AMI and the CABG EPMs was wage-
adjusted total episode spending. The data used for the wage-adjusted
total episode spending is the 3-year data pull previously described
that covers AMI and CABG episodes with admission dates from July 1,
2012, through December 31, 2014. For the purposes of the sample-size
calculation, we aim to be able to reliably identify between a 2-percent
and 3-percent reduction in wage-adjusted episode spending after 1 year
of experience. We chose this range because those numbers represent the
anticipated amount of the discount proposed to apply under various
conditions of the AMI and CABG EPMs' implementation.
The next consideration in calculating the necessary sample size is
the degree of certainty we will need for the statistical tests that
will be performed. In selecting the right sample size, there are two
types of errors that need to be considered: ``false positives'' and
``false negatives.'' A false positive occurs if a statistical test
concludes that a model was successful (that is, saved money) when it in
fact was not. A false negative occurs if a statistical test fails to
find statistically-significant evidence that the model was successful,
when it in fact was successful. In considering the minimum sample size
needs of the AMI and CABG EPMs, a standard guideline in the statistical
literature suggests calibrating statistical tests to generate no more
than a 5-percent chance of a false positive and selecting the sample
size to ensure no more than a 20-percent chance of a false negative. In
contrast, the proposed sample size for this project was based on a 10-
percent chance of a false positive and no more than a 30-percent chance
of a false negative in order to minimize reduce sample size
requirements to the greatest degree possible.
A third consideration in the sample-size calculation was the
appropriate unit of selection and whether it is necessary to base the
calculation on the number of MSAs, the number of hospitals, or the
number of episodes. We are proposing to base the sample size
calculation at the MSA level. The proposed EPMs are an example of what
is known as a ``nested comparative study.'' Under a nested comparative
study, assignment to an intervention or comparison arms of the study is
based on membership in pre-existing, identifiable group where the
groups are not formed at random, but rather through some physical,
social, geographic, or other connection among their members. Because
these groups are not formed at random, individual members of each group
are likely to share important commonalities. In the context of the
proposed EPMs spending and outcomes for patients cared for within a
given MSA are relatively similar to one another due to such factors as
the existence of common practice or referral patterns, the underlying
health in the population, and the availability of providers in an area.
In statistical terms, these commonalities create a positive
correlation (called an intra-class correlation) among hospitals or
beneficiaries in the same MSA. Due to that intra-class correlation, the
variability of any aggregate statistic--such as the estimated
difference in outcomes between the intervention and comparison arms of
the study--has two components--(1) variability attributable to
variation among hospitals or beneficiaries in a given MSA; and (2)
variability attributable to differences between MSAs. An accurate power
analysis must account for both components of variability.
In determining the necessary sample size, we take into
consideration the degree to which commonalities within MSAs exist and
the number of independent beneficiaries and hospitals expected to be
included in the EPM within each MSA. As part of this process, we
empirically examined the number of beneficiaries, the number of
hospitals, and the number of MSAs, as well as the level of correlation
in episode payments between each level. Based on this empirical
examination, we determined that the correlation was high enough that
the degree of variability would be primarily driven by the number of
MSAs in the model, indicating that the MSA is the appropriate unit of
analysis for the power calculations.
Using the aforementioned assumptions, a power calculation for AMI
was run which indicated that at 98 MSAs we would be able to reliably
detect a 3-percent reduction in wage-adjusted episode spending after 1
year with a false-positive rate of 10 percent and a false-negative rate
of between 20 percent and 40 percent. We are targeting a false-negative
rate of 30 percent. The extent to which this rate can be lowered will
depend on the ability of evaluation models to substantially reduce
variation through risk adjustment and modeling. We believe it is
prudent to choose a sample size where the targeted amount is in the
middle of this expected band.
We separately assessed the sample-size needs associated with CABG
episodes. At 98 MSAs, we anticipate being able to detect a 2.25-percent
reduction in wage-adjusted episode expenditures after 1 year with a
false-positive rate of 10 percent and a false-negative rate of between
20-40 percent. The effective number of MSAs where the CABG EPM will be
tested will be reduced because approximately 6 percent of eligible MSAs
had no CABG episodes in the reference year. However, our power
calculations do not lead us to believe we need to increase the sample
size based on this fact. The number of CABG MSAs can experience this
reduction and maintain equivalent levels of power to the AMI episodes.
(3) Method of Selecting MSAs
As previously discussed, we are seeking to choose 98 MSAs from our
pool of eligible MSAs through simple random selection. We propose to
make the selection in the final rule using SAS Enterprise Guide 7.1
software to run a computer algorithm SAS Enterprise Guide 7.1 and the
computer algorithm used to conduct selection represents an industry-
standard for generating advanced analytics and provides a rigorous,
standardized tool by which to satisfy the requirements of randomized
selection. The key SAS commands employed include a ``PROC
SURVEYSELECT'' statement coupled with the ``METHOD=SRS'' option used to
specify simple random sampling as the sample selection method. A random
number seed will be generated using the
[[Page 50829]]
birthdate of the person executing the program.\37\
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\37\ For more information on this procedure and the underlying
statistical methodology, please reference SAS support documentation
at: http://support.sas.com/documentation/cdl/en/statug/63033/HTML/default/viewer.htm#statug_sur veyselect_sect003.htm/.
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We seek comment on our proposal to implement the AMI and CABG
models in the selected MSAs, some of which may overlap with MSAs where
the CJR and SHFFT models also are being implemented.
C. Episode Definition for the EPMs
1. Background
Episode payment models incentivize improvement in the coordination
and quality of care experienced by a Medicare beneficiary, as well as
episode efficiency, by bundling payment for services furnished to the
beneficiary for specific clinical conditions over a defined period of
time. A key model design feature is the definition of the episodes
included in the model. The definition of episodes has two significant
dimensions--(1) a clinical dimension that describes which clinical
conditions and associated services are included in the model; and (2) a
time dimension that describes the beginning, middle, and end of the
model.
2. Overview of Three Proposed Episode Payment Models
We propose three new EPMs--AMI, CABG, and SHFFT--that each begin
with a hospitalization and extend 90 days after hospital discharge. The
proposed AMI model generally includes beneficiaries discharged under an
AMI MS-DRG (280-282), representing admission to an IPPS hospital for
AMI that is treated with medical management, or an IPPS admission for a
PCI MS-DRG (246-251) with an International Classification of Diseases
(ICD)-Clinical Modification (CM) AMI diagnosis code describing an
initial AMI diagnosis in the principal or a secondary diagnosis code
position.
The proposed CABG model generally includes beneficiaries discharged
under a CABG MS-DRG (231-236), representing an IPPS admission for this
coronary revascularization procedure irrespective of AMI diagnosis. The
proposed SHFFT model generally includes beneficiaries discharged under
hip and femur procedures except major joint MS-DRG (480-482),
representing an IPPS admission for a hip fixation procedure in the
setting of a hip fracture.
One reason these particular episodes were chosen for the proposed
EPMs is that the initiation of treatment for each of the three clinical
conditions included in an episode occurs almost exclusively during a
hospitalization, which we believe would minimize the possibility of
shifting beneficiaries in or out of the EPM based on the site-of-
service where treatment is initiated. The majority of evaluation and
treatment for AMI is performed in the inpatient hospital setting,
commonly beginning when beneficiaries present with symptoms to the
emergency department of a hospital. Patients experiencing an AMI are
almost uniformly admitted to the hospital for further evaluation and
management.\38\ Although PCIs can be performed and may be paid by
Medicare in the hospital outpatient setting in addition to being
performed during a hospitalization, the majority of patients
experiencing an AMI who are candidates for procedural revascularization
receive PCI procedures during the initial hospitalization for AMI where
evaluation also occurs.\39\ CABG procedures are furnished exclusively
in the inpatient hospital setting. We note that all of the Current
Procedural Terminology (CPT) codes that physicians report for CABG are
listed on the hospital Outpatient Prospective Payment System (OPPS)
inpatient-only list in Addendum E of the 2016 OPPS final rule with
comment period that is posted on the CMS Web site.\40\ The hip fixation
procedures performed in the SHFFT model also are predominantly
furnished in the inpatient hospital setting, and we further note that
almost all of the CPT codes that describe these procedures also are on
the OPPS inpatient-only list.
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\38\ Amsterdam et al. 2014 AHA/ACC Guideline for the Management
of Patients with Non-ST--Elevation Acute Coronary Syndromes.
Circulation. 2014; 130:e344--e426.
\39\ Episodes for beneficiaries with AMI initiated by all U.S.
IPPS hospitals not in Maryland and constructed using standardized
Medicare FFS Parts A and B claims, as proposed in this rule, that
end in CY 2014.
\40\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1633-FC.html.
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Hospitals' ability to identify EPM beneficiaries during the
hospitalization that begins the episode (hereinafter the anchor
hospitalization) also is an important consideration in developing
episode payment models that, like the CJR model, rely upon MS-DRG
assignment for IPPS claims following their submission in order to
identify beneficiaries for model inclusion. This is especially
important for medical management of conditions for which the
predictability of the ultimate MS-DRG for the hospitalization is less
certain than for surgical or procedural MS-DRGs. AMI represents a
relative exception among medical conditions as it is associated with
specific clinical and laboratory features that enable hospitals to
identify beneficiaries with AMI during the anchor hospitalization whom
would likely be included in an AMI model episode through their ultimate
discharge under an AMI MS-DRG. We note that ICD-CM coding rules allow
AMI diagnosis codes in both the primary and secondary position to map
to AMI MS-DRGs.\41\ In the case of procedural episodes such as CABG,
SHFFT, and AMI model episodes for beneficiaries treated with PCI, the
MS-DRG for the procedure performed would determine the ultimate MS-DRG
assignment for the hospitalization unless additional surgeries higher
in the MS-DRG hierarchy also are reported.\42\ Therefore, we propose
these three EPMs for clinical conditions where MS-DRG assignment is
likely to be certain and known during the anchor hospitalization, even
though treatment for AMI may involve only medical management. We
believe hospitals participating in the proposed EPMs would be able to
identify beneficiaries in EPM episodes through their AMI, CABG, and
SHFFT episode MS-DRGs during the anchor hospitalization, allowing
active coordination of EPM beneficiary care during and after
hospitalization.
---------------------------------------------------------------------------
\41\ Medical Severity Diagnosis Related Groups (MS-DRGs):
Definitions Manual. Version 33.0A. 3M Health Information Systems.
(October 1, 2015). https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Data-Files.html.
\42\ Medical Severity Diagnosis Related Groups (MS-DRGs):
Definitions Manual. Version 33.0A. 3M Health Information Systems.
(October 1, 2015). https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Data-Files.html.
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3. Clinical Dimensions of AMI, CABG, and SHFFT Model Episodes
As we stated in the CJR model Final Rule, we believe that a
straightforward approach for hospitals and other providers to identify
Medicare beneficiaries in these episode payment models would be
important for the care redesign that is required for EPM success, as
well as for operationalization of the proposed payment and other EPM
policies (80 FR 73299). Therefore, as in the CJR model, we propose that
an EPM episode would be initiated by an admission to an acute care
hospital for an anchor hospitalization paid under EPM-specific MS-DRGs
under the IPPS (80 FR 73300).
[[Page 50830]]
a. Definition of the Clinical Conditions Included in AMI, CABG, and
SHFFT Model Episodes
(1) AMI (Medical Management and PCI) Model
We propose the AMI model to incentivize improvements in the
coordination and quality of care, as well as episode efficiency, for
beneficiaries treated for AMI with either medical management or
coronary artery revascularization with PCI. We propose to define
beneficiary inclusion in the AMI model by discharge under an AMI MS-DRG
(280-282), representing those individuals admitted with AMI who receive
medical therapy but no revascularization, and discharge under a PCI MS-
DRG (246-251) with an ICD-10-CM diagnosis code of AMI on the IPPS claim
for the anchor hospitalization in the principal or secondary diagnosis
code position. We note that we would use AMI International
Classification of Diseases, 9th revision clinical modification (ICD-9-
CM) diagnosis codes to identify historical episodes for setting AMI
model-episode benchmark prices in the early performance years of the
AMI model. The Uniform Hospital Discharge Data Set (UHDDS) defines the
principal diagnosis for hospitalization as ``that condition established
after study to be chiefly responsible for occasioning the admission of
the patient to the hospital for care'' and other (secondary) diagnoses
as ``all conditions that coexist at the time of admission, that develop
subsequently, or that affect the treatment received and/or the length
of stay. Diagnoses that relate to an earlier episode which have no
bearing on the current hospital stay are to be excluded.'' \43\ We
propose to include those beneficiaries discharged under PCI MS-DRGs
with an AMI ICD-10-CM diagnosis code in the principal or secondary
diagnosis code position to ensure that beneficiaries with an AMI that
is not chiefly responsible for occasioning the hospitalization are
included in the AMI model because the AMI itself is likely to
substantially influence the hospitalization and post-discharge recovery
(and be responsible for leading to the PCI) even if an AMI ICD-10-CM
diagnosis code is reported in a secondary diagnosis code position. For
example, a beneficiary receiving a PCI with an ICD-10-CM diagnosis code
of pneumonia in the principal position and an AMI ICD-10-CM diagnosis
code in a secondary position would be included in the AMI model, which
would be appropriate because the course of the beneficiary's recovery
and management during the AMI model episode would be primarily
associated with the AMI and PCI. While pneumonia is typically an acute
illness that may sometimes result in hospitalization, underlying
chronic conditions may increase the likelihood that a beneficiary would
be hospitalized for pneumonia, a condition that is more commonly
treated on an outpatient basis. AMI in association with a
hospitalization for pneumonia would represent a sentinel event for the
beneficiary resulting from underlying CAD that signals a need for a
heightened focus on medical management of CAD and other beneficiary
risk factors for future cardiac events and that may themselves have
increased the beneficiary's risk for pneumonia. Thus, care coordination
and management in the 90 days post-hospital discharge for these
beneficiaries would be focused on managing CAD and the beneficiary's
cardiac function after the AMI.
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\43\ http://www.cdc.gov/nchs/data/icd/icd10cm_guidelines_2014.pdf.
---------------------------------------------------------------------------
We acknowledge that this proposal to identify beneficiaries
included in the AMI model through a combination of MS-DRGs and AMI ICD-
CM diagnosis codes represents a modification of the CJR model episode
definition methodology. The CJR model defined episodes based on MS-DRGs
alone, specifically MS-DRG 469 (Major joint replacement or reattachment
of lower extremity with Major Complications or Comorbidities (MCC)) and
MS-DRG 470 (Major joint replacement or reattachment of lower extremity
without MCC), because the anchor hospitalization for the CJR model was
defined by admission for a surgical procedure alone (80 FR 73280).
However, the proposed AMI model is defined by admission for a medical
condition that includes a range of treatment options, including medical
treatment and PCI. Therefore, to identify beneficiaries admitted for
AMI and treated with PCI requires ICD-CM diagnosis codes paired with
MS-DRGs to identify the subset of PCI MS-DRG cases associated with AMI
that would otherwise be excluded from an AMI model based solely on AMI
MS-DRGs.
For the purposes of defining historical AMI model episodes, we
propose to exclude beneficiaries discharged under PCI MS-DRGs with an
AMI ICD-9-CM diagnosis code in the principal or secondary position if
there is an intracardiac ICD-9-CM procedure code in any procedure code
field. Intracardiac procedure codes do not represent PCI procedures
indicated for the treatment of the coronary artery obstruction that
results in AMI, but instead represent a group of procedures indicated
for treating congenital cardiac malformations, cardiac valve disease,
and cardiac arrhythmias. These intracardiac procedures are performed
within the heart chambers rather than PCI procedures for AMI that are
performed within the coronary blood vessels. To reflect this clinical
distinction, the FY 2016 IPPS update removed intracardiac procedures
from MS-DRGs 246-251 and assigned them to new MS-DRGs 273 and 274 (80
FR 49367). Therefore, to be consistent with our proposed definition of
AMI model episodes that initiate with PCI MS-DRGs 246-251 (not with MS-
DRGs 273 and 274) and an AMI ICD-9-CM diagnosis code in the principal
or secondary position, we are proposing to define historical AMI model
episodes for beneficiaries discharged under PCI MS-DRGS 246-251 as
those that do not include the ICD-9-CM procedure codes in Table 2.
These codes are also posted on the CMS Web site at https://innovation.cms.gov/inititatives/epm.
Table 2--Proposed ICD-9-CM Procedure Codes in any Position on the IPPS
Claim for PCI MS-DRGS (246-251) That Do Not Define Historical AMI Model
Episodes
------------------------------------------------------------------------
ICD-9-CM Procedure code ICD-9-CM Procedure code description
------------------------------------------------------------------------
35.52............................. Repair of atrial septal defect with
prosthesis, closed technique.
35.96............................. Percutaneous balloon valvuloplasty.
35.97............................. Percutaneous mitral valve repair
with implant.
37.26............................. Catheter based invasive
electrophysiologic testing.
37.27............................. Cardiac mapping.
37.34............................. Excision or destruction of other
lesion or tissue of heart,
endovascular approach.
[[Page 50831]]
37.36............................. Excision, destruction, or exclusion
of left atrial appendage.
37.90............................. Insertion of left atrial appendage
device.
------------------------------------------------------------------------
In FY 2014, there were approximately 395,000 beneficiaries
discharged from a short-term acute care hospitalization (excluding
Maryland) with an AMI ICD-9-CM diagnosis code in the principal or
secondary position on the IPPS claim. Of these beneficiaries, 58
percent were discharged under MS-DRGs that would initiate an AMI model
episode, specifically an AMI MS-DRG (33 percent) and PCI MS-DRG (25
percent). Five percent of beneficiaries were discharged from CABG MS-
DRGs and 3 percent were discharged from AMI MS-DRGs representing death
during the hospitalization. The remaining 34 percent of beneficiaries
with an AMI ICD-CM diagnosis code in the principal or secondary
position were distributed across over approximately 300 other MS-DRGs,
with the septicemia MS-DRGs accounting for 8 percent and the remainder
accounting for 3 percent or less of beneficiaries with an AMI ICD-CM
diagnosis code on the IPPS claim.\44\ We note that the AMI ICD-9-CM
diagnosis code was most commonly in a secondary position for discharges
from these other MS-DRGs, likely representing beneficiaries
hospitalized for another condition who experienced an AMI during that
hospitalization. We note that CMS's AMI quality measures used in the
Hospital Inpatient Quality Reporting (HIQR) Program are based on all
beneficiaries discharged under any MS-DRG who have an AMI ICD-CM
diagnosis code only in the principal position, reflecting the measures'
focus on the most homogeneous beneficiary population with AMI as the
condition responsible for occasioning the hospital admission. This is
in contrast with our proposed use of an AMI ICD-10-CM diagnosis code in
the principal or a secondary position for the AMI model in order to
identify those beneficiaries receiving a PCI whose hospitalization and
post-discharge recovery and management would primarily be associated
with the PCI and AMI.
---------------------------------------------------------------------------
\44\ Inpatient claims from all U.S. IPPS hospitals not in
Maryland were derived from the October 2013-September 2014 Inpatient
Claims File located in the Chronic Conditions Warehouse.
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The proposed specifications for AMI episodes, including ICD-9-CM
AMI diagnosis codes for historical episodes used to set the initial AMI
model-episode benchmark prices and ICD-10-CM AMI diagnosis codes for
the proposed performance years of the model, are displayed in Table 3.
The ICD-9-CM intracardiac procedure codes used to exclude inpatient
claims with PCI MS-DRGS 246-251 from anchoring AMI model historical
episodes used to set initial AMI model-episode benchmark prices are
displayed in Table 3.
Based on Medicare claims data for historical AMI episodes ending in
CYs 2012-2014, the annual number of potentially eligible beneficiary
discharges for the AMI model nationally was approximately 168,000.\45\
This number is less than the approximately 229,000 discharges for
beneficiaries with AMI discharged from AMI MS-DRGs 280-282 and PCI MS-
DRGs 246-251 that could be expected to be included in the AMI model for
several reasons. Discharges do not result in historical episodes when a
beneficiary does not meet the beneficiary care inclusion criteria
discussed in section III.C.4.a.(1) of this proposed rule; is not
discharged alive from PCI MS-DRGS 246-251; is discharged from a
transfer hospital during a chained anchor hospitalization; or is
discharged from a readmission during an AMI model episode that does not
initiate new model episodes.
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\45\ Episodes for AMI beneficiaries initiated by all U.S. IPPS
hospitals not in Maryland and constructed using standardized
Medicare FFS Parts A and B claims, as proposed in this rule, that
began in CYs 2012-2014.
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The proposed list of ICD-9-CM and ICD-10-CM AMI diagnosis codes
used to identify beneficiaries discharged under a PCI MS-DRG (MS-DRGs
246-251) in historical episodes and during the performance years of the
model that will be included in the AMI model episodes are discussed in
section III.C.4.a.(2) of this proposed rule. To make changes to this
list as necessary based on annual ICD-10-CM coding changes or to
address issues raised by the public throughout the EPM performance
years, we propose implementing the following sub-regulatory process,
which mirrors the sub-regulatory process as described in the CJR model
final rule for updating hip fracture ICD-9-CM and ICD-10-CM diagnosis
codes (80 FR 73340) and for updating the exclusions list (80 FR 73305
and 73315). We propose to use this process on an annual, or more
frequent, basis to update the AMI ICD-10-CM diagnosis code list and to
address issues raised by the public. As part of this process we propose
the following standard when revising the list of ICD-10-CM diagnosis
codes representing AMI: The ICD-10-CM diagnosis code is sufficiently
specific that it represents an AMI. We propose to then post a list of
potential AMI ICD-10-CM diagnosis codes to the CMS Web site at https://innovation.cms.gov/inititatives/epm to allow for public input on our
planned application of these standards, and then adopt the AMI ICD-10-
CM diagnosis code list with posting to the CMS Web site of the final
AMI ICD-CM diagnosis code list after our consideration of the public
input. We would provide sufficient time for public input based on the
complexity of potential revisions under consideration, typically at
least 30 days, and, while we would not respond to individual comments
as would be required in a regulatory process, we could discuss the
reasons for our decisions about changes in response to public input
with interested stakeholders.
The proposals for identifying the beneficiaries included in the AMI
model and the sub-regulatory process for updating the AMI ICD-10-CM
diagnosis code list are included in Sec. 512.100(c)(1) and (d),
respectively. We seek comment on our proposals to identify
beneficiaries included in the AMI model and the sub-regulatory process
for updating the AMI ICD-10-CM diagnosis code list. The proposal to
exclude inpatient claims with PCI MS-DRGS 246-251 from anchoring AMI
model historical episodes used to set initial AMI model-episode
benchmark prices when there is an ICD-9-CM intracardiac procedure code
on the claim is included in Sec. 512.100(d)(4). We seek comment on our
proposal to exclude inpatient claims with PCI MS-DRGS 246-251 from
anchoring AMI model historical episodes used to set initial AMI model-
episode benchmark prices when there is an ICD-9-CM intracardiac
procedure code on the claim.
[[Page 50832]]
(2) CABG Model
We propose the CABG model to incentivize improvements in the
coordination and quality of care, as well as episode efficiency, for
beneficiaries treated with CABG irrespective of AMI during the CABG
hospitalization, thereby including beneficiaries undergoing elective
CABG in the CABG model as well as beneficiaries with AMI who have a
CABG during their initial AMI treatment. The CABG model is similar to
the CJR model in that the anchor hospitalization is defined by
admission for a surgical procedure, which is defined by the MS-DRGs for
that procedure alone (80 FR 73280). All CABG procedures are performed
in the inpatient hospital setting. Thus, we propose to include
beneficiaries admitted and discharged from an anchor hospitalization
paid under CABG MS-DRGs (231-236) under the IPPS in the CABG model.
Based on Medicare claims data for historical CABG episodes beginning in
CYs 2012-2014, the annual number of potentially eligible beneficiary
discharges for the CABG model nationally was approximately 48,000.\46\
---------------------------------------------------------------------------
\46\ Episodes for CABG beneficiaries initiated by all U.S. IPPS
hospitals not in Maryland and constructed using standardized
Medicare FFS Parts A and B claims, as proposed in this rule, that
began in CYs 2012-2014.
---------------------------------------------------------------------------
The proposal for identifying beneficiaries included in the CABG
model is included in Sec. 512.100(c)(2). We seek comment on our
proposal to identify beneficiaries included in the CABG model.
(3) SHFFT (Excludes Lower Extremity Joint Replacement) Model
We propose the SHFFT model to incentivize improvements in the
coordination and quality of care, as well as episode efficiency, for
beneficiaries treated surgically for hip and femur fractures, other
than hip arthroplasty. Together, the CJR and SHFFT models cover all
surgical treatment options (that is, hip arthroplasty and fixation) for
Medicare beneficiaries with hip fracture.
The SHFFT model is similar to the CJR model in that the anchor
hospitalization is defined by admission for a surgical procedure, which
is defined by the MS-DRGs for that procedure alone (80 FR 73280).
Additionally, most SHFFT procedures are furnished in the inpatient
hospital setting, consisting primarily of hip fixation procedures, with
or without reduction of the fracture, as well as open and closed
surgical approaches. Thus, we propose to include beneficiaries admitted
and discharged from an anchor hospitalization paid under SHFFT MS-DRGs
(480-482) under the IPPS in the SHFFT model. Based on Medicare claims
data for historical SHFFT episodes beginning in CYs 20122014, the
annual number of potentially eligible beneficiary discharges for the
SHFFT model nationally was approximately 109,000.\47\
---------------------------------------------------------------------------
\47\ Episodes for SHFFT beneficiaries initiated by all U.S. IPPS
hospitals not in Maryland and constructed using standardized
Medicare FFS Parts A and B claims, as proposed in this rule that
began in CYs 2012-2014.
---------------------------------------------------------------------------
The proposal for identifying beneficiaries included in the SHFFT
model is included in Sec. 512.100(c)(3). We seek comment on our
proposal to identify beneficiaries included in the SHFFT model.
b. Definition of the Related Services Included in EPM Episodes
The general principles for the proposed definition of related
services are the same for the AMI, CABG, and SHFFT models, so we
address them in a single discussion in this section. Like the CJR
model, we are interested in testing inclusive AMI, CABG, and SHFFT
model episodes to incentivize comprehensive, coordinated, patient-
centered care for the beneficiary throughout the episode (80 FR 73303).
Therefore, we propose to exclude Medicare items and services furnished
during the EPM episodes only when unrelated to the EPM episode
diagnosis and procedures based on clinical rationale that would result
in standard exclusions from all of the episodes in a single EPM. Thus,
we propose to include all items and services paid under Medicare Part A
and Part B unless they fall under an exclusion because they are
unrelated to the EPM episodes.
Also like the CJR model, we propose that the items and services
ultimately included in the EPM episodes after the exclusions are
applied are called related items and services, and that Medicare
spending for related items and services be included in the historical
data used to set EPM-episode benchmark prices and in the calculation of
actual EPM episode payments that would be compared against the quality-
adjusted target price to assess the performance of EPM participants (80
FR 73303 and 73315). Additionally, we propose that Medicare spending
for unrelated items and services (excluded from the EPMs' episode
definitions) would not be included in the historical data used to set
EPM-episode benchmark prices or in the calculation of actual EPM
episode payments. We propose that related items and services for EPM
episodes would include the following items and services paid under
Medicare Part A and Part B, after the EPM-specific exclusions are
applied:
Physicians' services.
Inpatient hospital services.
Inpatient psychiatric facility (IPF) services.
Long-Term Care Hospital (LTCH) services.
Inpatient Rehabilitation Facility (IRF) services.
Skilled Nursing Facility (SNF) services.
Home Health Agency (HHA) services.
Hospital outpatient services.
Independent outpatient therapy services.
Clinical laboratory services.
Durable medical equipment.
Part B drugs.
Hospice.
We note that inpatient hospital services would include services
paid through IPPS operating and capital payments. The AMI, CABG, and
SHFFT model episodes also could include certain per-member-per-month
model payments as discussed in section III.D.6.d. of this proposed
rule. These proposed items and services for the EPMs are the same items
and services included in CJR model episodes (80 FR 73303 and 73315).
Similar to the CJR model and for the reasons explained in the CJR
Final Rule, we propose to exclude drugs that are paid outside of the
MS-DRGs included in the EPM episode definitions, specifically
hemophilia clotting factors, identified by CPT code, diagnosis code,
and revenue center on IPPS claims, from the EPM episodes (80 FR 73303
and 73315). Hemophilia clotting factors, in contrast to other drugs
that are administered during a hospitalization and paid through the MS-
DRG, are paid separately by Medicare in recognition that clotting
factors are costly and essential to appropriate care of certain
beneficiaries. Therefore, we believe there are no EPM episode
efficiencies to be gained in the variable use of these high cost drugs.
We also propose to exclude IPPS new technology add-on payments for
drugs, technologies, and services from these EPM episodes, excluding
them from both the actual historical episode data used to set EPM-
episode benchmark prices and from actual EPM episode payments that are
reconciled to the quality-adjusted target prices like the CJR model (80
FR 73303-73304 and 73315). This would apply to both the anchor
hospitalization and any related
[[Page 50833]]
readmissions during the EPM episodes. New technology add-on payments
are made separately and in addition to the MS-DRG payment under the
IPPS for specific new drugs, technologies, and services that
substantially improve the diagnosis or treatment of Medicare
beneficiaries and would be inadequately paid under the MS-DRG system.
We believe it would not be appropriate for the EPM to potentially
diminish beneficiaries' access to new technologies or to burden
hospitals who choose to use these new drugs, technologies, or services
with concern about these payments counting toward EPM participants'
actual EPM episode payment. Additionally, new drugs, technologies, or
services approved for the add-on payments vary unpredictably over time
in their application to specific clinical conditions.
Finally, we propose to exclude OPPS transitional pass-through
payments for medical devices as defined in Sec. 419.66 from the EPM
episodes because, through the established OPPS review process, we have
determined that these technologies have a substantial cost but also
lead to substantial clinical improvement for Medicare beneficiaries.
This proposal also is consistent with the CJR model final exclusions
policy (80 FR 73308 and 73315).
We propose to follow the same general principles in determining
other proposed excluded Part A and Part B services from the EPM
episodes that we use in the CJR model in order to promote coordinated,
high-quality, patient-centered care (80 FR 73304). These include
identifying excluded (unrelated) services rather than included
(related) services based on clinical review. We would operationalize
these principles for the new EPMs, as we do for the CJR model, by
excluding unrelated inpatient hospital admissions during the EPM
episode by identifying MS-DRGs for exclusion on an EPM-specific basis
(80 FR 73304 through 73312 and 73315). We would further exclude
unrelated Part B services during the EPM episode based on the diagnosis
code on the claim by identifying categories of ICD-CM codes for
exclusion (identified by code ranges) on an EPM-specific basis. ICD-9-
CM diagnosis code exclusions would apply to historical episodes used to
construct EPM-episode benchmark prices, while ICD-10-CM diagnosis code
exclusions would apply to EPM episodes during the EPMs' performance
years. We propose to identify unrelated Part B services and
readmissions based on the BPCI Model 2 Part B exclusions lists that
apply to the anchor MS-DRG that initiates the EPM episode, or to the
price MS-DRG if it is different than the anchor MS-DRG as described
further in section III.D.4.b.(2)(a) of this proposed rule. This
proposal is consistent with our use of the BPCI Model 2 LEJR ICD-9-CM,
ICD-10-CM, and MS-DRG exclusions lists in the CJR model (80 FR 73304
and 73315).
The BPCI episode-specific exclusions lists were initially developed
more than 3 years ago for BPCI through a collaborative effort of CMS
staff, including physicians from medical and surgical specialties,
coding experts, claims processing experts, and health services
researchers. The lists have been shared with thousands of entities and
individuals participating in episodes in one or more phases of BPCI,
and have undergone refinement in response to stakeholder input about
specific diagnoses for exclusion, resulting in only minimal changes
over the last 3 years. Thus, the BPCI exclusions lists have been vetted
broadly in the health care community; refined based on input from a
wide variety of providers, researchers and other stakeholders; and
successfully operationalized in the BPCI models. We propose their use
in the AMI, CABG, and SHFFT models based on our confidence related to
our several years of experience that these definitions are reasonable
and workable for AMI, CABG, and SHFFT model episodes, for both
providers and CMS, and based on our rulemaking for the CJR model. We
note that the BPCI Model 2 exclusions lists for the 48 clinical
conditions being tested in the BPCI models include lists that apply to
every MS-DRG that could be an anchor MS-DRG (or price MS-DRG, if
applicable) for the proposed AMI, CABG, and SHFFT model episodes.
Similar to the CJR model, we propose to include in EPM episodes all
Part A services furnished post-hospital discharge during the EPM
episode, as these services are typically intended to be comprehensive
in nature (80 FR 73304 and 73315). We specifically propose to exclude
unrelated hospital readmissions for MS-DRGs that group to the following
categories of diagnoses: Oncology, trauma medical admissions, surgery
for chronic conditions unrelated to a condition likely to have been
affected by care furnished during the EPM episode, and surgery for
acute conditions unrelated to a condition resulting from or likely to
have been affected by care during the EPM episode. The rationale for
these exclusions is the same as the rationale for their exclusion in
the CJR model (80 FR 73304).
Specifically with respect to Part B services, similar to the CJR
model, we propose to exclude acute disease diagnoses unrelated to a
condition resulting from or likely to have been affected by care during
the EPM episode, and certain chronic disease diagnoses, as specified by
CMS on a diagnosis-by-diagnosis basis, depending on whether the
condition was likely to have been affected by care during the EPM
episode or whether substantial services were likely to be provided for
the chronic condition during the EPM episode (80 FR 73305 and 73315).
Thus, we would include all Part B services with principal diagnosis
codes on the associated Part B claims that are directly related
(clinically and per coding conventions) to EPM episodes, claims for
diagnoses that are related to the quality and safety of care furnished
during EPM episodes, and claims for services for diagnoses that are
related to preexisting chronic conditions such as diabetes, which may
be affected by care furnished during EPM episodes.
In general, the anchor MS-DRG that initiates the AMI, CABG, or
SHFFT episode would determine the exclusions list that applies to the
EPM episode. For example, AMI model episodes may have different
exclusions lists applied based on whether the AMI model episode is
initiated by admission to the participant hospital that results in
discharge from an AMI anchor MS-DRG or a PCI anchor MS-DRG with AMI
ICD-10-CM diagnosis code. If a price MS-DRG applies to the AMI model
episode that includes a chained anchor hospitalization as described in
section III.D.4.b.(2)(a) of this proposed rule, the exclusions list
that applies to the price MS-DRG would apply to the AMI model episode.
Complete lists of proposed excluded MS-DRGs for readmissions and
proposed excluded ICD-CM codes for Part B services furnished during EPM
episodes after EPM beneficiary discharge from an anchor or chained
anchor hospitalization in the AMI, CABG, and SHFFT models are posted on
the CMS Web site at https://innovation.cms.gov/initiatives/epm.
Like the CJR model policy, we propose that these exclusion lists
would be updated by sub-regulatory guidance on an annual basis, at a
minimum, to reflect annual changes to ICD-10-CM coding and annual
changes to the MS-DRGs under the IPPS, as well as to address any other
issues that are brought to our attention throughout the course of the
EPMs' performance period (80 FR 73304 through 73305 and 73315). The
standards for this updating process reflect the aforementioned general
principles for determining excluded services. That is, we propose to
not
[[Page 50834]]
exclude any items or services that are directly related to the EPM
episode diagnosis or procedure (for example, a subsequent admission for
heart failure or repeat revascularization) or the quality or safety of
care (for example, sternal wound infection following CABG); or to
chronic conditions that may be affected by the EPM diagnosis or
procedure and the post-discharge care (for example, diabetes). We
propose to exclude items and services for chronic conditions that are
generally not affected by the EPM diagnosis or procedure and the post-
discharge care (for example, prostate removal for cancer), and for
acute clinical conditions not arising from existing EPM episode-related
chronic clinical conditions or complications from the EPM episode (for
example, appendectomy).
Similar to the CJR model, we propose that the potential revised
exclusions, which could include additions to or deletions from the
exclusions lists, would be posted to the CMS Web site to allow for
public input (80 FR 73305 and 73315). Through the process for public
input on potential revised exclusions and then posting of the final
revised exclusions, we propose to provide information to the public
about when the revisions would take effect and to which episodes they
would apply.
The proposal for included services for an EPM is included in Sec.
512.210(a). The proposal for excluded services from the EPM episode is
included in Sec. 512.210(b). The proposal for updating the lists of
excluded services for EPMs is included in Sec. 512.210(c). We seek
comment on our proposals for included and excluded services for the
AMI, CABG, and SHFFT models and updating the lists of excluded
services.
4. EPM Episodes
a. Beneficiary Care Inclusion Criteria and Beginning of EPM Episodes
(1) General Beneficiary Care Inclusion Criteria
Because of the clinical variability leading up to these EPM
episodes and the challenge of identifying unrelated services given the
multiple chronic conditions experienced by many EPM beneficiaries, we
propose to follow the CJR model precedent and not begin an EPM episode
prior to the anchor hospitalization (80 FR 73315 and 73318). We propose
that all services that are already included in the IPPS payment based
on established Medicare policies (for example, 3-day payment window
payment policies) would be included in these EPM episodes, and that the
defined population of Medicare beneficiaries whose care would be
included in the EPMs would meet all of the following criteria on
admission to the anchor or chained anchor hospitalization:
Enrolled in Medicare Part A and Part B.
Eligible for Medicare not on the basis of end-stage renal
disease.
Not enrolled in any managed care plan (for example,
Medicare Advantage, Health Care Prepayment Plans, cost-based health
maintenance organizations).
Not covered under a United Mine Workers of America health
plan, which provides health care benefits for retired mine workers.
Have Medicare as their primary payer.
Not aligned to an ACO in the Next Generation ACO model or
an ACO in a track of the Comprehensive ESRD Care Initiative
incorporating downside risk for financial losses.
Not under the care of an attending or operating physician,
as designated on the inpatient hospital claim, who is a member of a
physician group practice that initiates BPCI Model 2 episodes at the
EPM participant for the MS-DRG that would be the anchor MS-DRG under
the EPM.
Not already in any BPCI model episode.
Not already in an AMI, SHFFT, CABG or CJR model episode
with an episode definition that does not exclude the MS-DRG that would
be the anchor MS-DRG under the applicable EPM.
For a discussion of our proposal to exclude certain ACO-aligned
beneficiaries from EPM episodes, we refer to section III.D.6.c.(3) of
this proposed rule. For a discussion of our proposals for addressing
potential overlap of beneficiaries in episode payment models that are
relevant to these last two criteria, we refer to sections III.D.6.c.(1)
and (2) of this proposed rule.
The proposal for beneficiary care inclusion policies is included in
Sec. 512.230. We seek comment on our proposal of beneficiary care
inclusion policies.
(2) Beginning AMI Model Episodes
We propose that, as long as the beneficiary meets the general
beneficiary care inclusion criteria, then an AMI model episode would
begin with admission of a Medicare beneficiary to an IPPS hospital for
the following MS-DRGs, where the specific MS-DRG is called the anchor
MS-DRG for the episode:
AMI MS-DRGs--
++ 280 (Acute myocardial infarction, discharged alive with MCC);
++ 281 (Acute myocardial infarction, discharged alive with CC); and
++ 282 (Acute myocardial infarction, discharged alive without CC/
MCC).
PCI MS-DRGs, when the claim includes an AMI ICD-10-CM
diagnosis code in the principal or secondary position on the IPPS claim
as specified in Table 3--
++ 246 (Percutaneous cardiovascular procedures with drug-eluting
stent with MCC or 4+ vessels/stents);
++ 247 (Percutaneous cardiovascular procedures with drug-eluting
stent without MCC);
++ 248 (Percutaneous cardiovascular procedures with non-drug-
eluting stent with MCC or 4+ vessels/stents);
++ 249 (Percutaneous cardiovascular procedures with non-drug-
eluting stent without MCC);
++ 250 (Percutaneous cardiovascular procedures without coronary
artery stent with MCC); and
++ 251 (Percutaneous cardiovascular procedures without coronary
artery stent without MCC).
Table 3 displays the ICD-9-CM codes that we propose to use to
identify historical AMI episodes for beneficiaries discharged from PCI
MS-DRGs, as well as the ICD-10-CM diagnosis codes that would be used to
identify AMI model episodes for beneficiaries discharged from PCI MS-
DRGs throughout the duration of the AMI model. The proposed sub-
regulatory process for updating this AMI ICD-10-CM diagnosis code list
is described previously in section III.C.3.a.(1) of this proposed rule.
We first identified the ICD-9-CM diagnosis codes for the initial
AMI episode-of-care that were historically used to report care for a
newly diagnosed AMI patient admitted to the hospital. These codes all
have a fifth digit of ``1'' and were applicable until the patient was
discharged from acute medical care, including for any transfers to and
from other acute care facilities that occurred. These AMI ICD-9-CM
diagnosis codes would be used to identify historical AMI episodes for
developing AMI model-episode benchmark prices for anchor PCI MS-DRGs.
We propose to cross-walk the ICD-9-CM diagnosis codes for the initial
AMI episode-of-care to the ICD-10-CM diagnosis codes that would be
reported for similar beneficiaries during the AMI model performance
years. The proposed crosswalk in Table 3 is consistent with the
crosswalk CMS posted for public comment regarding ICD-9-CM to ICD-10-CM
diagnosis
[[Page 50835]]
codes used for HIQR Program measures, including AMI quality
measures.\48\
---------------------------------------------------------------------------
\48\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Downloads/HIQR-ICD9-to-ICD10-Tables.pdf.
Table 3--Proposed ICD-9-CM and ICD-10-CM AMI Diagnosis Codes in the Principal or Secondary Position on the IPPS
Claim for PCI MS-DRGS (246-251) That Initiate AMI Model Episodes
----------------------------------------------------------------------------------------------------------------
ICD-10-CM
ICD-9-CM Diagnosis code ICD-9-CM Description Diagnosis code ICD-10-CM Description
----------------------------------------------------------------------------------------------------------------
410.01.............................. Acute myocardial infarction 121.09 ST elevation (STEMI)
of anterolateral wall, myocardial infarction
initial episode of care. involving other coronary
artery of anterior wall.
122.0 Subsequent ST elevation
(STEMI) myocardial
infarction of anterior
wall.
410.11.............................. Acute myocardial infarction 121.01 ST elevation (STEMI)
of other anterior wall, myocardial infarction
initial episode of care. involving left main
coronary artery.
121.02 ST elevation (STEMI)
myocardial infarction
involving left anterior
descending coronary artery.
121.09 ST elevation (STEMI)
myocardial infarction
involving other coronary
artery of anterior wall.
122.0 Subsequent ST elevation
(STEMI) myocardial
infarction of anterior
wall.
410.21.............................. Acute myocardial infarction 121.10 ST elevation (STEMI)
of inferolateral wall, myocardial infarction
initial episode of care. involving other coronary
artery of inferior wall.
122.1 Subsequent ST elevation
(STEMI) myocardial
infarction of inferior
wall.
410.31.............................. Acute myocardial infarction 121.11 ST elevation (STEMI)
of inferoposterior wall, myocardial infarction
initial episode of care. involving right coronary
artery.
122.1 Subsequent ST elevation
(STEMI) myocardial
infarction of inferior
wall.
410.41.............................. Acute myocardial infarction 121.19 ST elevation (STEMI)
of other inferior wall, myocardial infarction
initial episode of care. involving other coronary
artery of inferior wall.
122.1 Subsequent ST elevation
(STEMI) myocardial
infarction of inferior
wall.
410.51.............................. Acute myocardial infarction 121.29 ST elevation (STEMI)
of other lateral wall, myocardial infarction
initial episode of care. involving other sites.
122.8 Subsequent ST elevation
(STEMI) myocardial
infarction of other sites.
410.61.............................. True posterior wall 121.29 ST elevation (STEMI)
infarction, initial episode myocardial infarction
of care. involving other sites.
122.8 Subsequent ST elevation
(STEMI) myocardial
infarction of other sites.
410.71.............................. Subendocardial infarction, 121.4 Non[dash]ST elevation
initial episode of care. (NSTEMI) myocardial
infarction.
122.2 Subsequent non[dash]ST
elevation (NSTEMI)
myocardial infarction.
410.81.............................. Acute myocardial infarction 121.21 ST elevation (STEMI)
of other specified sites, myocardial infarction
initial episode of care. involving left circumflex
coronary artery.
121.29 ST elevation (STEMI)
myocardial infarction
involving other sites.
122.8 Subsequent ST elevation
(STEMI) myocardial
infarction of other sites.
410.91.............................. Acute myocardial infarction 121.3 ST elevation (STEMI)
of unspecified site, myocardial infarction of
initial episode of care. unspecified site.
122.9 Subsequent ST elevation
(STEMI) myocardial
infarction of unspecified
site.
----------------------------------------------------------------------------------------------------------------
The proposal for beginning AMI model episodes is included in Sec.
512.240(a)(1). We seek comment on our proposal to begin AMI model
episodes.
(3) Beginning CABG Model Episodes
We propose that, as long as a beneficiary meets the general
beneficiary care inclusion criteria, a CABG model episode would begin
with the admission of a Medicare beneficiary to an IPPS hospital for a
CABG that is paid under the following CABG MS-DRGs and the specific MS-
DRG is called the anchor MS-DRG for the episode:
231 (Coronary bypass with percutaneous transluminal
coronary angioplasty (PTCA) with MCC).
232 (Coronary bypass with PTCA without MCC).
233 (Coronary bypass with cardiac catheterization with
MCC).
234 (Coronary bypass with cardiac catheterization without
MCC).
235 (Coronary bypass without cardiac catheterization with
MCC).
236 (Coronary bypass without cardiac catheterization
without MCC).
The proposal for beginning CABG episodes is included in Sec.
512.240(b)(1). We seek comment on our proposal to begin CABG model
episodes.
[[Page 50836]]
(4) Beginning SHFFT Episodes
We propose that as long as a beneficiary meets the general
inclusion criteria, a SHFFT model episode would begin with the
admission of a Medicare beneficiary to an IPPS hospital for surgical
treatment of hip or femur fracture (other than joint replacement) that
is paid under the following SHFFT MS-DRGs and where the specific MS-DRG
is called the anchor MS-DRG for the episode:
480 (Hip and femur procedures except major joint with
MCC).
481 (Hip and femur procedures except major joint with
complication or comorbidity (CC).
482 (Hip and femur procedures except major joint without
CC or MCC).
The proposal for beginning SHFFT model episodes is included in
Sec. 512.240(c)(1). We seek comment on our proposal to begin SHFFT
model episodes.
(5) Special Policies for Hospital Transfers of Beneficiaries With AMI
The asymmetric distribution of cardiac care across hospitals makes
transfer, either from an inpatient admission or from the emergency
department (without inpatient admission) of one hospital to another, a
common consideration in the treatment course for beneficiaries with an
initial diagnosis of AMI. Therefore, transfer for cardiac care is an
important consideration for the AMI and CABG models.
The availability of revascularization and intensive cardiac care
are particularly important considerations in the transfer of
beneficiaries with an AMI. A substantial portion of hospitals do not
have revascularization capability (that is, a cardiac catheterization
lab for PCI or cardiothoracic surgeons who can perform CABG) or
cardiovascular intensive care units (CVICU) and, therefore, must
transfer beneficiaries to provide access to these services. In the PCI
and CABG examples, the discharge from the transfer hospital that
accepted the beneficiary would result in discharge under the MS-DRGs
for PCI (246-251) or CABG (231-236). For the CVICU example, the
transfer hospital's discharge MS-DRG would be AMI (280-282). There is
evidence of the asymmetric distribution of cardiac care in the 2014
IPPS and critical access hospital claims data: while 4,332 hospitals
submitted at least one claim for an AMI MS-DRG, only 1,755 (41 percent)
and 1,156 (27 percent) of these hospitals filed at least one claim for
PCI or CABG MS-DRGs, respectively.\49\
---------------------------------------------------------------------------
\49\ AMI, CABG and PCI MS-DRG inpatient claims from all U.S.
IPPS hospitals and CAHs derived from the 2014 Geographic Variations
Inpatient Claims File located in the Chronic Conditions Warehouse.
---------------------------------------------------------------------------
The potential transfer scenarios are best illustrated by the care
pathways experienced by beneficiaries with AMI. These beneficiaries
typically present to a hospital's emergency department where the
evaluation identifies the AMI diagnosis and determines the initial
indicated treatments. Depending on the beneficiary's clinical needs and
the hospital's treatment capacity, the beneficiary could be--
Admitted to the initial treating hospital, with no
transfer to another hospital during the initial hospitalization for
AMI. We refer to this scenario as no transfer;
Admitted to the initial treating hospital and later
transferred to a transfer hospital. We refer to this scenario as
inpatient-to-inpatient transfer and the transfer hospital as an i-i
transfer hospital; or
Transferred from the initial treating hospital to a
transfer hospital without admission to the initial treating hospital.
We refer to this scenario as outpatient-to-inpatient transfer and the
transfer hospital as an o-i transfer hospital.
Our proposals and alternatives considered for these scenarios are
described in detail in this section. In our proposals for AMI or CABG
model episodes for initial AMI care, our overarching policy is that
every AMI or CABG model episode would begin at the first AMI or CABG
model participant to which the beneficiary is admitted for an AMI MS-
DRG, PCI MS-DRG with an AMI ICD-CM diagnosis code, or CABG MS-DRG. The
AMI or CABG model participant where the episode begins would then be
financially responsible for the AMI or CABG model episode unless the
episode is canceled.
Based on our analysis of Medicare claims data, about 75 percent of
historical AMI episodes and CABG episodes for beneficiaries with AMI
begin through the emergency department of the hospital where the anchor
hospitalization for the AMI or CABG model episode would occur. In
another 18 percent of historical AMI episodes and CABG episodes for
beneficiaries with AMI, the anchor hospitalization occurs at a transfer
hospital following an emergency department visit at another hospital
without admission to that hospital for an MS-DRG that would initiate an
AMI or CABG model episode.\50\
---------------------------------------------------------------------------
\50\ Episode for beneficiaries with AMI initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule that end in CY 2014.
---------------------------------------------------------------------------
In each of these scenarios, policies to determine which episode
type applies, the beginning of the episode, and the specific hospital
with financial responsibility for the episode must be determined (for
example, AMI or CABG, if CABG is provided as an initial treatment in an
outpatient-to-inpatient or inpatient-to-inpatient scenario). In this
section, we discuss each of the scenarios in detail and provide a
summary of the scenarios in Table 4.
In the no transfer scenario, the episode would begin upon admission
to an AMI or CABG model participant under circumstances that meet the
criteria discussed in sections III.C.4.a.(1) and (2) or (3) of this
proposed rule, and the AMI or CABG model episode that applies would be
determined by the specific MS-DRG for the anchor hospitalization.
Financial responsibility for the episode would be attributed to the
sole treating hospital involved in the initial AMI care. Under this
proposal, the treating hospital's quality measure performance would
determine the effective discount factor to be applied to the AMI or
CABG model benchmark episode price for the episode at reconciliation as
described in section III.D.4.b.(10) of this proposed rule.
The inpatient-to-inpatient transfer scenario has several potential
outcomes. If the beneficiary initially presents for AMI care to a
hospital that is not an AMI model participant and is admitted and then
transferred to an i-i transfer hospital that is an AMI or CABG model
participant, the episode would first initiate at the i-i transfer
hospital and, therefore, the i-i transfer hospital would be financially
responsible for the AMI or CABG model episode. The i-i transfer
hospital's quality measure performance would determine the effective
discount factor to be applied to the AMI or CABG model benchmark
episode price for the episode at reconciliation as described in section
III.D.4.b.(10) of this proposed rule.
Conversely, if a beneficiary initially presents for AMI care to an
AMI model participant and is admitted and then transferred to an i-i
transfer hospital (hereinafter a chained anchor hospitalization) and
the i-i transfer hospital is not an AMI or CABG model participant, the
episode would initiate at the initial treating hospital and would only
be canceled for beneficiaries discharged from the i-i transfer hospital
[[Page 50837]]
under MS-DRGs that are not anchor MS-DRGs for AMI or CABG model
episodes is discussed in section III.C.4.b. of this proposed rule. The
initial treating hospital's quality measure performance would determine
the effective discount factor to be applied to the AMI or CABG model
benchmark episode price for the episode at reconciliation as described
in section III.D.4.b.(10) of this proposed rule. We also refer to
section III.D.4.b.(2)(a) of this proposed rule for further discussion
of price MS-DRGs that may differ from the anchor MS-DRG in AMI model
episodes that include a chained anchor hospitalization, in order to
provide pricing adjustments for episodes where the initial treating
hospital is responsible for the AMI model episode.
Inpatient-to-inpatient transfers between AMI and CABG model
participant hospitals are further considered in this section and
specifically include beneficiaries experiencing an AMI who are
transferred for revascularization (that is, PCI or CABG) or a higher
level of medical AMI care. We note that of all beneficiaries
experiencing an AMI in historical episodes, about half received no
revascularization (PCI or CABG) during the anchor hospitalization or
the 90-day post-hospital discharge period, about 40 percent received a
PCI, and less than 10 percent had CABG surgery.\51\ Moreover, three-
quarters of CABG procedures and over 90 percent of PCIs for
beneficiaries experiencing an AMI occurred at the hospital that first
admitted the beneficiary for an inpatient hospitalization.\52\
---------------------------------------------------------------------------
\51\ Episodes for beneficiaries with AMI initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule, and that end in CY 2014.
\52\ Episodes for beneficiaries with AMI initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule, and that end in CY 2014.
---------------------------------------------------------------------------
However, given the asymmetric distribution of cardiac care capacity
there will be beneficiaries who initiate an AMI model episode by
admission to an initial treating hospital but then require transfer to
an i-i transfer hospital for additional treatment during the AMI model
episode, resulting in a chained anchor hospitalization. For historical
AMI episodes ending in CY 2014, only about 12 percent of beneficiaries
who would have initiated an AMI model episode through admission and
assignment to an AMI MS-DRG at the initial treating hospital were
transferred to an i-i transfer hospital, with 30 percent and 20 percent
receiving PCI or CABG, respectively, at the i-i transfer hospital.
Another 20 percent were discharged from the i-i transfer hospital in
the chained anchor hospitalization under an AMI MS-DRG. The remaining
30 percent of beneficiaries were discharged from the i-i transfer
hospital in the chained anchor hospitalization under other MS-DRGs that
would not have initiated AMI or CABG model episodes, including cardiac
valve surgery, septicemia, and renal failure. From the perspective of
hospital capacity and transfer patterns, most hospitals transferred
less than 10 percent of beneficiaries initiating a historical AMI
episode under an AMI MS-DRG at the first admitting hospital, and only a
handful of hospitals transferred the majority of their patients in this
scenario.\53\ This small number of hospitals that transferred the
majority of their patients includes a range of urban and rural
hospitals with 50 to 250 beds.
---------------------------------------------------------------------------
\53\ Episodes for AMI beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that end in CY 2014.
---------------------------------------------------------------------------
The need to transfer a beneficiary in an AMI model episode during
the anchor hospitalization for appropriate care that results in a
chained anchor hospitalization where the hospitals are both AMI or CABG
model participants raises considerations about whether attribution of
the AMI model episode should be to the first treating hospital that
admitted the beneficiary or the i-i transfer hospital, as well as
considerations about the specific model (AMI or CABG) for attribution
of the episode in some circumstances. For example, if the first
treating hospital initiates an AMI model episode by admitting a
beneficiary and then transfers the beneficiary to another hospital
where the beneficiary is treated and ultimately discharged from acute
care, ending the chained anchor hospitalization under a CABG MS-DRG,
then we need to determine whether the beneficiary would be included in
the AMI or CABG model, which hospital assumes financial responsibility
for the beneficiary's episode, and under what circumstances, if any,
would the AMI model episode be canceled if a transfer occurs.
In considering the model episode that includes the beneficiary's
care and accountability for the beneficiary in inpatient-to-inpatient
transfer scenarios between AMI and CABG model participant hospitals
that result in a chained anchor hospitalization for AMI, several
factors are relevant, including the timing of final discharge
disposition of the beneficiary, including to post-acute care; the
location of the post-acute care; the identity and location of the
physician who is most responsible for managing the beneficiary's care
after discharge; and consistency across other CMS transfer policies. We
note that while 64 percent of CABG beneficiaries in historical episodes
received post-acute care services following discharge from the anchor
hospitalization (most commonly home health services--43 percent
received home health services only and 13 percent a combination of home
health and SNF services), only 36 percent of historical AMI
beneficiaries received post-acute services.\54\ Of further relevance
for beneficiaries with an AMI diagnosis is that significant follow up
care is usually performed by cardiologists who manage the patient's
underlying cardiovascular disease, rather than the interventional
cardiologist or cardiothoracic surgeon that perform the
revascularization procedure. PCI procedures, billed by interventional
cardiologists, have a 0-day global period, reflecting that follow up
care is not typically furnished by interventional cardiologists. We
further note that patients in commercial programs that require travel
to regional centers of excellence for CABG generally only stay in the
remote location away from the patient's home for a week or so post-
hospital discharge. We expect that beneficiaries hospitalized for
treatment of AMI, even if they are transferred to a revascularization
hospital resulting in a chained anchor hospitalization, would receive
most follow up care in their local communities, a view that was
supported by many commenters on the CJR model proposed rule who
asserted that many patients requiring post-acute care prefer to return
to their home communities for that care following hospital discharge
(80 FR 23457). Finally, consistency across other CMS program policies
when a beneficiary with an AMI experiences an inpatient-to-inpatient
transfer is relevant to developing policies for the proposed AMI and
CABG models. Specifically, we note that the Hospital-Level, Risk-
Standardized Payment Associated with a 30-Day Episode of Care for AMI
(NQF #2431) measure used in the hospital value-based purchasing (HVBP)
Program attributes payments for transferred beneficiaries to the
hospital that
[[Page 50838]]
admitted the patient for the initial AMI hospitalization.\55\
---------------------------------------------------------------------------
\54\ Episodes for AMI and CABG beneficiaries initiated by all
U.S. IPPS hospitals and constructed using standardized Medicare FFS
Parts A and B claims, as proposed in this rule that end in CY 2014.
\55\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
---------------------------------------------------------------------------
Based on these considerations, we propose that once an AMI model
episode is initiated at an AMI model participant hospital through an
inpatient hospitalization, the AMI model episode would continue under
the financial responsibility of that participant hospital, regardless
of whether the beneficiary is transferred to another AMI or CABG model
participant hospital for further medical management of AMI, or for a
PCI or CABG during a chained anchor hospitalization. Under this
proposal, the initial treating hospital's quality measure performance
would determine the effective discount factor to be applied to the AMI
model benchmark episode price for the episode at reconciliation as
described in section III.D.4.b.(10) of this proposed rule. Our proposal
to cancel AMI model episodes for beneficiaries discharged from the i-i
transfer hospital under MS-DRGs that are not anchor MS-DRGs for AMI or
CABG model episodes is discussed in section III.C.4.b. of this proposed
rule. We also refer to section III.D.4.b.(2)(a) of this proposed rule
for further discussion of price MS-DRGs that may differ from the anchor
MS-DRG in AMI model episodes that include a chained anchor
hospitalization, in order to provide pricing adjustments for episodes
where the initial treating hospital is responsible for the AMI model
episode.
We note that we do not propose to cancel the AMI model episode even
if the transfer and admission to the i-i transfer hospital would
otherwise initiate a CABG model episode at the i-i transfer hospital.
We believe that once the AMI model episode has been initiated, all
related care during the episode (including hospital care for transfers
and related readmissions for CABG) should be fully attributed to the
AMI model episode in the manner described in this section for the
episode and that the first hospital that initiated the AMI model
episode should be financially responsible for the AMI episode.
Therefore, we do not propose to cancel the AMI model episode if a CABG
is performed during a chained anchor hospitalization, nor do we propose
that a beneficiary could simultaneously be in an AMI and CABG model
episode for overlapping periods of time due to the different MS-DRGs
that apply during the chained anchor hospitalization. Instead, we would
make an AMI model episode pricing adjustment for these circumstances by
paying the AMI model participant based on a price MS-DRG that is
different from the anchor MS-DRG to reflect Medicare payment for the
CABG as discussed in section III.D.4.b.(2)(a) of this proposed rule.
We considered several alternatives to our proposal for AMI model
episode attribution for inpatient-to-inpatient transfer scenario where
both hospitals are AMI or CABG model participants. First, we considered
canceling the AMI model episode initiated at the initial treating
hospital when a transfer occurs, and basing any AMI or CABG model
episode initiation on the MS-DRG for the final i-i transfer hospital
admission in the chained anchor hospitalization as long as that latter
hospital is an AMI or CABG model participant. This would place
financial responsibility for the episode on the i-i transfer hospital
if the beneficiary goes on to be discharged from acute care at that
hospital. Attributing episodes under this alternative policy would
assign beneficiaries to the final i-i transfer hospital for the AMI or
CABG model episode based on the model episode definitions in sections
III.C.4.a.(2) and (3) of this proposed rule. That is, if the
beneficiary is discharged from the final admission in the chained
anchor hospitalization under an AMI MS-DRG or a PCI MS-DRG, then the
AMI model episode initiated at the initial treating hospital would be
canceled and the i-i transfer hospital accepting the beneficiary on
referral would initiate an AMI model episode. Similarly, if the
beneficiary is discharged from the final admission in the chained
anchor hospitalization under a CABG MS-DRG, then the AMI model episode
initiated at the first hospital would be canceled and the i-i transfer
hospital accepting the beneficiary on referral would initiate a CABG
model episode. Under this alternative, the i-i transfer hospital's
quality measure performance would determine the effective discount
factor to be applied to the AMI or CABG model benchmark episode price
for the episode at reconciliation as described in section
III.D.4.b.(10) of this proposed rule. However, we do not propose this
alternative because we believe that post-acute care and care management
following hospital discharge are more likely to be effectively provided
near the beneficiary's home community, rather than near the i-i
transfer hospital accepting the beneficiary upon referral.
Second, we considered proposing an episode hierarchy such that,
during a chained anchor hospitalization, the most resource-intensive
MS-DRG during the whole chained anchor hospitalization would determine
the model episode and the financially responsible hospital for the
episode. For example, if we establish CABG, PCI, and AMI MS-DRGs in
descending order of inpatient hospital resource-intensity, we would
initiate a model episode based on the most resource-intensive MS-DRG
during the chained anchor hospitalization and attribute the model
episode to the hospital discharging the beneficiary under that MS-DRG.
Under this scenario, either the initial treating or i-i transfer
hospital's quality measure performance would determine the effective
discount factor to be applied to the AMI or CABG model benchmark
episode price for the episode at reconciliation as described in section
III.D.4.b.(10) of this proposed rule, depending on the specific
hospital discharging the beneficiary under the most resource-intensive
MS-DRG during the chained anchor hospitalization. However, we do not
propose this alternative because we believe, like the first alternative
we considered, this could frequently lead to episode responsibility
being attributed to the i-i transfer hospital when the local hospital
first caring for the beneficiary with AMI may be better positioned to
coordinate care in the beneficiary's home community.
Thus, our proposal would place responsibility for care during the
90-day post-hospital discharge period in the AMI model episode on the
AMI model participant hospital to which the beneficiary initially
presented for AMI care and was admitted, rather than on the i-i
transfer hospital to which the beneficiary was transferred after
initiating the AMI model episode. Given the broad episode definition of
AMI model episodes, we believe that the post-discharge care required
following hospitalization that includes CABG, PCI, or medical
management is best coordinated and managed by the hospital that
originally admitted the beneficiary for the AMI. Such post-discharge
care could include follow up for adherence to cardiac rehabilitation
referral and management of the beneficiary's underlying CAD and
comorbidities. Even in the case of the more common surgical
complications of CABG, such as wound infection, the beneficiary
commonly would be admitted to the local hospital for treatment.
We further propose that, as discussed in section III.I.3 of this
proposed rule, hospitals may be collaborators in the AMI, CABG, and
SHFFT models in order to increase the financial alignment of hospitals
and other EPM collaborators with EPM participants that are
[[Page 50839]]
financially responsible for EPM episodes. Therefore, we expect that
community hospital participants in the AMI model would be able to enter
into collaboration agreements with i-i transfer hospitals accepting AMI
model beneficiaries on referral to allow sharing of episode
reconciliation payments or repayment responsibility with the i-i
transfer hospitals if those hospitals play a significant role in care
redesign of AMI or CABG care pathways or management of beneficiaries
throughout AMI or CABG model episodes, including during the 90 days
post-hospital discharge. We expect that community hospitals would need
to coordinate closely with i-i transfer hospitals accepting AMI model
beneficiaries on referral as the beneficiaries in AMI model episodes
are discharged from those hospitals, in order to improve the quality
and efficiency of AMI model episodes. This coordination could
potentially be enhanced if i-i transfer hospitals are AMI model
collaborators with financial incentives that are aligned with those of
the AMI model participants through sharing arrangements.
The proposal for AMI model episode attribution in circumstances
that involve inpatient-to-inpatient transfers of beneficiaries with AMI
is included in Sec. 512.240(a)(2). We seek comment on our proposal for
AMI model episode attribution in circumstances that involve inpatient-
to-inpatient transfers of beneficiaries with AMI, including comment on
the alternatives considered.
In the outpatient-to-inpatient transfer scenario where a
beneficiary with AMI is transferred from the emergency department of
the initial treating hospital without admission to that hospital as an
inpatient to an o-i transfer hospital for admission, we propose that
the AMI or CABG model episode would begin at the o-i transfer hospital
based on the MS-DRG (and AMI ICD-CM diagnosis code if a PCI MS-DRG
applies) that is assigned to that anchor hospitalization. That is, if a
beneficiary receives initial AMI care in a hospital emergency
department without admission and is transferred to an AMI or CABG model
participant (the o-i transfer hospital) for admission, then the AMI or
CABG model episode would begin in the first hospital involved in the
beneficiary's AMI or CABG care that admits the beneficiary as an
inpatient, specifically the o-i transfer hospital. Therefore, the o-i
transfer hospital would be financially responsible for the AMI or CABG
model episode. This proposed attribution is in accordance with the
proposed AMI and CABG model rules, as discussed in sections
III.C.4.a.(2) and (3) of this proposed rule, that initiate an AMI model
episode with a hospitalization that results in discharge from an AMI
MS-DRG or PCI MS-DRG with an AMI ICD-CM diagnosis code in the principal
or secondary position from an AMI model participant or a CABG model
episode with a hospitalization that results in discharge from a CABG
MS-DRG. Under this proposal, the o-i transfer hospital's quality
measure performance would determine the effective discount factor to be
applied to the AMI or CABG model benchmark episode price for the
episode at reconciliation as described in section III.D.4.b.(10) of
this proposed rule. Under this proposal, regardless of whether the
initial treating hospital is an AMI or CABG model participant, an AMI
or CABG model episode would only be initiated at the o-i transfer
hospital if that hospital is an AMI or CABG model participant.
We considered an overarching alternative policy that would begin
every AMI or CABG model episode at the first AMI or CABG model
participant at which either:
The beneficiary presented to the emergency department for
initial AMI care before being transferred to an o-i transfer hospital;
or
The beneficiary was admitted for an AMI MS-DRG, PCI MS-DRG
with an AMI ICD-CM diagnosis code, or a CABG MS-DRG.
The AMI or CABG model participant where the episode begins would
then be financially responsible for the AMI or CABG model episode
unless the episode is canceled. Under this alternative, there would no
changes to our proposals for attributing episodes with no transfers or
inpatient-to-inpatient transfers.
However, under this alternative, if the beneficiary presented for
initial AMI care to the emergency department of an AMI or CABG model
participant, the AMI or CABG model episode would begin at this initial
treating hospital when a beneficiary is transferred from the emergency
department for his or her first inpatient hospitalization which occurs
at an o-i transfer hospital. This would place financial responsibility
for the AMI or CABG model episode on the initial treating hospital
despite the fact that the beneficiary was transferred from that
hospital without being admitted, and the initial treating hospital's
quality measure performance would determine the effective discount
factor to be applied to the AMI or CABG model benchmark episode price
for the episode at reconciliation as described in section
III.D.4.b.(10) of this proposed rule.
Identifying the emergency department visit at the initial treating
hospital would require using Field (Form Locator) 15--Point of Origin
for Admission or Visit code on the CMS 1450 IPPS claim from the o-i
transfer hospital to identify transfer from another hospital and
linking that claim to the hospital outpatient claims from the initial
treating hospital for the emergency department visit and other hospital
outpatient services that occurred within a certain period of time prior
to the o-i transfer hospital admission and that are related to the AMI
care. The episode would be assigned to the AMI model even if the
beneficiary received a CABG at the o-i transfer hospital, and we would
assign financial responsibility for the AMI model episode to the
initial treating hospital. Under this alternative, the initial treating
hospital's quality measure performance would determine the effective
discount factor to be applied to the AMI model benchmark episode price
for the episode at reconciliation as described in section
III.D.4.b.(10) of this proposed rule. We would also need to identify
other types of related services to include in the episode that would
begin prior to the o-i transfer hospital admission, such as physicians'
services for care in the emergency department.
This alternative would have the benefit of consistently including
all care in each AMI or CABG model episode that occurs following
presentation of a beneficiary with AMI to the emergency department of
an AMI or CABG model participant in the AMI or CABG model episode,
regardless of whether an AMI or CABG model episode involves no
transfer, o-i transfer, or i-i transfer. However, because this
alternative would begin the AMI model episode prior to the initial
hospital admission, we would need to establish additional policies for
identifying the beneficiaries who initiate these episodes and define
the timeframe and services that would be included in the AMI or CABG
model episode prior to admission to the o-i transfer hospital.
We do not propose this alternative because we believe the policies
necessary to begin the AMI or CABG model episode at the first treating
hospital when an inpatient hospitalization does not occur would be
complex, challenging to operationalize, and require assumptions about
the relationship of care to the AMI based solely on administrative
claims data that are insufficient to ensure we can accurately identify
related care. We believe it remains problematic to define the services
to be included in AMI or CABG model episodes if those services precede
an inpatient hospitalization that
[[Page 50840]]
would otherwise initiate the AMI or CABG model episode. For example, we
would need to define the timeframe for beginning an AMI or CABG model
episode with an emergency department visit for AMI that results in a
transfer to the o-i transfer hospital, as well as the Part A and Part B
services to be included in the AMI or CABG model episode that would
result. As we discuss in section III.C.4.a.(1) of this proposed rule,
we do not propose to begin any EPM episode prior to the anchor
hospitalization because of the clinical variability leading up to all
EPM episodes and the challenge of identifying unrelated services prior
to the inpatient hospitalization. Thus, we do not propose to make an
exception for transfers from the emergency department of the initial
treating AMI or CABG model participant hospital when the beneficiary
with AMI is not admitted to that hospital.
We seek comment on the proposal for AMI and CABG model episode
initiation and attribution for the outpatient-to-inpatient transfer
scenario, as well as the alternative considered that would begin an
episode upon presentation of a beneficiary for initial AMI care to the
emergency department of an AMI or CABG model participant when the care
results in an outpatient-to-inpatient transfer.
Table 4 provides a summary of our proposals for episode initiation
and attribution at the beginning of AMI care for no transfer,
inpatient-to-inpatient transfer, and outpatient-to-inpatient transfer
scenarios, including a description of how these relate to the
participation in the AMI or CABG models of hospitals providing initial
AMI care.
Table 4--Proposed Initiation and Attribution of AMI and CABG Model
Episodes That Involve No Transfer, or Outpatient-to-Inpatient or
Inpatient-to-Inpatient Transfers at the Beginning of AMI Care
------------------------------------------------------------------------
Episode initiation and
Scenario attribution
------------------------------------------------------------------------
No transfer (participant): Beneficiary Initiate AMI or CABG model
admitted to an initial treating episode based on anchor
hospital that is a participant in the hospitalization MS-DRG.
AMI or CABG model for an AMI MS-DRG, Attribute episode to the
PCI MS-DRG with AMI ICD-CM diagnosis initial treating hospital.
code, or CABG MS-DRG.
No transfer (nonparticipant): No AMI or CABG model episode is
Beneficiary admitted to an initial initiated.
treating hospital that is not a
participant in the AMI or CABG model
for an AMI MS-DRG, PCI MS-DRG with AMI
ICD-CM diagnosis code, or CABG MS-DRG.
Inpatient-to-inpatient transfer Initiate AMI or CABG model
(nonparticipant to participant): episode based on the MS-DRG at
Beneficiary admitted to an initial i-i transfer hospital.
treating hospital that is not an AMI Attribute episode to the i-i
or CABG model participant and later transfer hospital.
transferred to an i-i transfer
hospital that is an AMI or CABG model
participant for an AMI MS-DRG, PCI MS-
DRG with AMI ICD-CM diagnosis code, or
CABG MS-DRG.
Inpatient-to-inpatient transfer Initiate AMI or CABG model
(participant to participant or episode based on anchor
participant to nonparticipant): hospitalization MS-DRG at
Beneficiary admitted to an initial initial treating hospital. If
treating hospital that is an AMI or the chained anchor
CABG model participant for an AMI MS- hospitalization results in a
DRG, PCI MS-DRG with AMI ICD-CM final AMI, PCI, or CABG MS-
diagnosis code, or CABG MS-DRG and DRG, calculate episode
later transferred to an i-i transfer benchmark price based on the
hospital for an AMI, PCI, or CABG MS- AMI, PCI or CABG MS-DRG with
DRG, regardless of whether the i-i the highest IPPS weight. If
transfer hospital is an AMI or CABG the final MS-DRG is not an
model participant. AMI, PCI, or CABG MS-DRG,
cancel the episode. Attribute
episode to the initial
treating hospital.
Outpatient-to-inpatient transfer Initiate AMI or CABG model
(nonparticipant to participant or episode based on anchor
participant to participant): hospitalization MS-DRG at o-i
Beneficiary transferred without transfer hospital. Attribute
admission from the initial treating episode to the o-i transfer
hospital, regardless of whether the hospital.
initial treating hospital is an AMI or
CABG model participant, to a o-i
transfer hospital that is an AMI or
CABG model participant and is
discharged from the o-i transfer
hospital for an AMI MS-DRG, PCI MS-DRG
with AMI ICD-CM diagnosis code, or
CABG MS-DRG.
Outpatient-to-inpatient transfer No AMI or CABG model episode is
(participant to nonparticipant): initiated.
Beneficiary transferred without
admission from the initial treating
hospital that is an AMI or CABG
participant to an o-i transfer
hospital that is not an AMI or CABG
model participant.
------------------------------------------------------------------------
b. Middle of EPM Episodes
Similar to the CJR model, we propose that once an EPM episode
begins, it would continue until the end of the episode as described in
the following section, unless certain circumstances arise during the
episode (80 FR 73318). When an EPM episode is canceled, we propose that
the services furnished to beneficiaries prior to and following the EPM
episode cancellation would continue to be paid by Medicare as usual but
there would be no actual EPM episode spending calculation that would be
reconciled against the EPM quality-adjusted target price.
Specifically, we propose that the following circumstances occurring
during an EPM episode would cancel the EPM episode:
The beneficiary ceases to meet any of the general
beneficiary inclusion criteria described in section III.C.4.a.(1) of
this proposed rule, except the three criteria regarding inclusion in
other episode payment model episodes.
The beneficiary dies during the anchor hospitalization.
The beneficiary initiates any BPCI model episode.
For purposes of cancellation of EPM episodes for beneficiary
overlap with other episode payment models, we propose that if a
beneficiary in an EPM episode would initiate any BPCI model episode,
the EPM episode would be canceled. We refer to section III.D.6.c.(1) of
this proposed rule for further discussion of our proposals addressing
potential overlap of beneficiaries in the proposed EPMs with BPCI. We
also refer to section III.D.6.c.(3) of this proposed rule for
discussion of our proposal to cancel EPM episodes for beneficiaries who
become aligned with specified ACOs during EPM episodes.
Our proposal to only cancel the EPM episode if a beneficiary dies
during the anchor hospitalization differs from the final CJR model
policy that cancels an
[[Page 50841]]
episode if a beneficiary dies any time during the episode (80 FR
73318). As discussed in the CJR model Final Rule for LEJR episode, we
believe that it also would be appropriate to cancel an episode in the
AMI, CABG, and SHFFT models when a beneficiary dies during the anchor
hospitalization as there would be limited incentives for efficiency
that could be expected during the anchor hospitalization itself (80 FR
73318). We agreed with commenters on the CJR model proposed rule that
we should cancel CJR model episodes for death any time during those
episodes, because beneficiary deaths following LEJR would be uncommon
and expected to vary unpredictably, leading to extremely high or low
episode spending that was not typical for a LEJR episode. A recent
analysis that pooled results from 32 studies showed the incidence of
mortality during the first 30 and 90 days following hip replacement to
be 0.30 percent and 0.65 percent, respectively, confirming our
expectation of low mortality rates during LEJR episodes.\56\ In
contrast, the 30-day national CABG and AMI mortality rates as displayed
on Hospital Compare are significantly higher at approximately 3 percent
and 14 percent respectively.\57\ Several CMS programs use 30-day
mortality measures for CABG and AMI as measures of hospital quality,
and these measures are proposed for use in the pay-for-performance
methodology for the CABG and AMI models as discussed in section
III.E.3.f. of this proposed rule. Similarly, a 2009 study shows a 30-
day hip fracture mortality rate for Medicare beneficiaries of
approximately 5 percent, significantly higher than the mortality rate
following LEJR procedures.\58\ Thus, we would expect that deaths during
SHFFT model episodes would be more common than in CJR model episodes.
Because beneficiaries in AMI, CABG, and SHFFT model episodes are at
significant risk of death during these episodes that extends 90 days
post-hospital discharge, we consider mortality to be a harmful
beneficiary outcome that should be targeted for improvement through
care redesign incentivized by the EPMs for these clinical conditions.
Therefore, we do not believe it would be appropriate to exclude
beneficiaries from AMI, CABG, or SHFFT model episodes who die any time
during the episode like we do in the CJR model. Instead, we propose to
maintain beneficiary episodes in the EPMs even if death occurs during
the episodes, meaning we would calculate actual EPM episode spending
when beneficiaries die following discharge from the anchor
hospitalization but within the 90-day post-hospital discharge episode
duration and reconcile it against the quality-adjusted target price. We
believe this proposal would encourage EPM participants to actively
manage EPM beneficiaries to reduce their risk of death, especially as
death is often preceded by expensive care for emergencies and
complications. Because of the higher mortality rates for all of the
proposed EPM episodes than for LEJR episodes in the CJR model, we do
not consider mortality following hospital discharge to be atypical and,
therefore, we propose to cancel EPM episodes only for death during the
anchor hospitalization.
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\56\ Berstock JR, Beswick AD, Lenguerrand E, Whitehouse MR, Blom
AW. Mortality after total hip replacement surgery: A systematic
review. Bone & Joint Research. 2014; 3(6):175-182. doi:10.1302/2046-
3758.36.2000239.
\57\ https://www.medicare.gov/hospitalcompare/search.html.
\58\ Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB.
Incidence and Mortality of Hip Fractures in the United States. JAMA.
2009;302(14):1573-1579. doi:10.1001/jama.2009.1462.
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We further propose that the following circumstances also would
cancel an AMI model episode in the circumstances of a chained anchor
hospitalization when the beneficiary is discharged from acute care
under an MS-DRG from the final transfer hospital in the chained anchor
hospitalization that could not, itself, initiate an AMI or CABG model
episode, regardless of whether the final transfer hospital is an AMI or
CABG model participant (that is, the episode would be canceled if the
final transfer hospital MS-DRG is any MS-DRG other than an AMI MS-DRG,
PCI MS-DRG, or CABG MS-DRG);
While we would begin an AMI model episode with the first
hospitalization in the chained anchor hospitalization that would
initiate an episode as discussed in section III.C.4.a.(5) of this
proposed rule, we understand that a variety of types of care at i-i
transfer hospitals could occur following the discharge from the
hospital that began the AMI model episode during the chained anchor
hospitalization, most commonly further medical management of AMI and
revascularization that could be appropriately included in the AMI model
episode. We further note that less than 0.2 percent of beneficiaries in
historical AMI episodes have more than one inpatient-to-inpatient
transfer during the chained anchor hospitalization.\59\ However, in
some cases transfer to another hospital during an AMI episode could
result in a final i-i transfer hospital MS-DRG for care that would not
itself have initiated an AMI (or CABG) model episode if all inpatient
hospital care were furnished at a single hospital. For example, a
beneficiary in an AMI model episode could be transferred to another
hospital where the beneficiary undergoes cardiac valve surgery or
treatment for renal failure or stroke. In some of these cases, further
treatment at the i-i transfer hospital could be due to potentially
avoidable complications resulting from insufficient care management
during the AMI model episode that is initiated at the first hospital.
In other cases the care at the i-i transfer hospital could be
unavoidable and clinically appropriate, resulting from the
beneficiary's evolving AMI or other associated chronic conditions and
the specific capabilities of the hospital that initiated the AMI model
episode. Therefore, we believe it would be most appropriate to cancel
AMI model episodes under the circumstances when a beneficiary in an AMI
model episode is discharged from acute care under an MS-DRG from the
final i-i transfer hospital in the chained anchor hospitalization that
is not an AMI, PCI, or CABG MS-DRG that could initiate an AMI or CABG
model episode (that is, the episode would be canceled if the final
transfer hospitalization MS-DRG is any MS-DRG other than an AMI, PCI,
or CABG MS-DRG). We note that we would not require an AMI ICD-10-CM
diagnosis code on all claims in a chained anchor hospitalization for a
beneficiary in an AMI model episode in order to provide to an adjusted
payment at the price MS-DRG for the AMI model episode as discussed in
section III.D.4.b.(2)(a) of this proposed rule. We also would not
cancel the AMI model episode if an AMI ICD-10-CM diagnosis code is not
on the claim for the final transfer hospitalization, as long as the
discharge is under an AMI, PCI, or CABG MS-DRG. Because the beneficiary
would be in an AMI model episode during a chained anchor
hospitalization, we would treat the beneficiary who is transferred to
an i-i transfer hospital according to all policies that apply to the
diagnosis of AMI in the CABG and AMI models, regardless of whether an
AMI ICD-10-CM diagnosis code was on the PCI or CABG MS-DRG claim from
the final i-i transfer hospital. Overall, this proposal would treat the
hospital that initiated the AMI model episode and then transferred the
beneficiary most similarly to a hospital that furnished all of the
beneficiary's inpatient care itself,
[[Page 50842]]
with respect to whether or not the beneficiary's care is ultimately
included as an episode in the AMI model.
---------------------------------------------------------------------------
\59\ Episodes for AMI beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that end in CY 2014.
---------------------------------------------------------------------------
Finally, we do not propose to cancel an AMI episode altogether for
a CABG readmission during the 90-day post-hospital discharge period or
cancel the AMI model episode and initiate a CABG model episode because
planned CABG readmission following an anchor hospitalization that
initiates an AMI model episode may be an appropriate clinical pathway
for certain beneficiaries. Instead, we propose to provide an adjusted
AMI model-episode benchmark price that includes a CABG readmission in
such circumstances so as not to financially penalize participant
hospitals for relatively uncommon, costly, clinically appropriate care
patterns for beneficiaries in AMI model episodes. We refer to section
III.D.4.b.(2)(c) of this proposed rule for discussion of the adjusted
AMI model-episode benchmark price that would apply in the case of CABG
readmission during an AMI model episode.
The proposals for cancellation of EPM episodes are included in
Sec. 512.240(a)(3), (b)(2), and (c)(2). We seek comment on our
proposals for cancellation of EPM episodes.
c. End of EPM Episodes
(1) AMI and CABG Models
We propose a 90-day post-hospital discharge episode duration for
AMI model episodes. AMI in general, whether managed medically or with
revascularization, has a lengthy recovery period, during which the
beneficiary has a higher than average risk of additional cardiac events
and other complications, as well as higher utilization of diagnostic
testing and related cardiac procedures. AMI frequently serves as a
sentinel event that marks the need for a heightened focus on medical
management of coronary artery disease and other beneficiary risk
factors for future cardiac events, cardiac rehabilitation over multiple
months, and beneficiary education and engagement. Given the broad
episode definition for AMI model episodes that includes beneficiaries
receiving both medical and PCI management for an acute event, we do not
believe that an episode longer than 90 days would be feasible due to
the higher risk of including unrelated services in the episode beyond
several months after hospital discharge. However, we believe that 90-
day post-hospital discharge episodes would provide substantial
incentives for aggressive medical management, cardiac rehabilitation,
and beneficiary education and engagement, whereas a shorter episode
duration would have less effect. We acknowledge that ongoing disease
management for beneficiaries with cardiovascular disease must extend
long after the conclusion of the proposed AMI model episodes.
Nevertheless, we believe the proposed 90-day post-hospital discharge
episode duration remains appropriate for an episode payment model
focused around a hospitalization. We expect that the medical management
and care coordination during AMI model episodes would continue to be
provided as beneficiaries transition out of AMI model episodes,
potentially into a primary care medical home or other model or program
with accountability for population health, such as an ACO.
We further note based on analysis of historical episodes that about
10 percent of beneficiaries hospitalized with AMI who received a CABG
received the CABG between 2 and 90 days post-discharge from the anchor
hospitalization (these beneficiaries would be in AMI model episodes),
while the remaining 90 percent of CABGs for beneficiaries hospitalized
with AMI were provided during the initial hospitalization (these
beneficiaries would in CABG model episodes). In contrast, fewer than 3
percent of those AMI model beneficiaries who received an inpatient or
outpatient PCI during an AMI model episode received the PCI between 2
and 90 days post-discharge from the anchor hospitalization, while more
than 97 percent received the PCI during the anchor hospitalization.\60\
We refer to section III.D.4.b.(2)(c) of this proposed rule for further
discussion of pricing adjustments and alternatives considered for
setting EPM-episode benchmark prices for AMI model episodes where PCI
or CABG occurs during the AMI episode but post-discharge from the
anchor or chained anchor hospitalization.
---------------------------------------------------------------------------
\60\ Episodes for AMI beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that end in CY 2014.
---------------------------------------------------------------------------
Finally, for similar reasons, we believe CABG model episodes should
extend 90 days post-hospital discharge. About one-third of CABG
procedures are performed in the context of a hospital admission for
AMI, leading to the same considerations discussed previously in this
section around the appropriate episode duration for beneficiaries with
AMI. The remaining CABG model beneficiaries are likely to have
significant ischemic heart disease, making the occurrence of CABG
itself a sentinel event, like AMI, that marks the need for a heightened
focus on medical management of CAD and other beneficiary risk factors
for future cardiac events, cardiac rehabilitation over multiple months,
and beneficiary education and engagement. Moreover, CABG procedures
have 90-day global periods under the Physician Fee Schedule, consistent
with the lengthy period of recovery associated with major chest
surgery. Thus, a 90-day post-hospital discharge episode duration is
consistent with the recovery period from CABG surgery. We acknowledge
that ongoing disease management for beneficiaries with cardiovascular
disease must extend long after the conclusion of the proposed CABG
model episodes. Nevertheless, we believe the proposed 90-day post-
hospital discharge episode duration remains appropriate for an episode
payment model focused around a hospitalization. We expect that the
medical management and care coordination during CABG model episodes
would continue to be provided as beneficiaries transition out of CABG
model episodes, potentially into a primary care medical home or other
model or program with accountability for population health, such as an
ACO.
As in the CJR model, we propose that the day of discharge from the
anchor hospitalization counts as day 1 of the post-hospital discharge
period (80 FR 73324). However, in the case of an AMI model episode that
includes a chained anchor hospitalization, we would count the day of
discharge from the final hospitalization in the chained anchor
hospitalization as day 1 of the post-hospital discharge period. Since
the post-hospital discharge period is intended to extend 90 days for
recovery following hospital discharge, we believe it is appropriate
under these circumstances to begin the 90-day count when the
beneficiary is ultimately discharged from acute care for the first time
during the AMI model episode. However, the hospital that initiated the
AMI model episode in the chained anchor hospitalization would continue
to be responsible in the AMI model for the episode discussed previously
in section III.C.4.a.(5) of this proposed rule.
The proposals for the end of AMI and CABG model episodes are
included in Sec. Sec. 512.240(a)(1) and (b)(1), respectively. We seek
comment on our proposals to end AMI and CABG model episodes.
(2) SHFFT Model
We believe that SHFFT model beneficiaries are similar to CJR model
beneficiaries who undergo hip replacement for fracture. We believe
[[Page 50843]]
that the same episode duration as the CJR model of 90 days is
appropriate for SHFFT model episodes in order to include the full time
for recovery of function for these beneficiaries, which extends beyond
60 days based on patterns of post-acute care provider use (80 FR 73319
through 73324). Therefore, we propose a 90-day post-hospital discharge
duration for SHFFT model episodes.
The proposal for the end of SHFFT model episodes are included in
Sec. 512.240(c)(1). We seek comment on our proposal to end SHFFT model
episodes.
III. Provisions of the Proposed Regulations
D. Methodology for Setting EPM Episode Prices and Paying EPM
Participants in the AMI, CABG, and SHFFT Models
1. Background
a. Overview
We propose that the AMI, CABG, and SHFFT models would provide
incentives for EPM participants to work with other health care
providers and suppliers to improve the quality and efficiency of care
for Medicare beneficiaries by paying EPM participants or holding them
responsible for repaying Medicare based on EPM participants'
performance with respect to the quality and spending for AMI, CABG, and
SHFFT episodes in a manner similar to the CJR model. Given the general
similarity between the design of the CJR model and these EPMs, there is
precedent for adopting the general payment and pricing parameters used
under the CJR model, with modification to appropriately pay for EPM
episodes that include the different clinical conditions treated in AMI,
CABG, and SHFFT model episodes. The following sections describe our
proposals for the:
Performance year, retrospective episode payments, and two-
sided risk EPMs.
Adjustments to actual EPM-episode payments and to
historical episode payments used to set episode prices.
EPM episode price-setting methodologies.
Process for reconciliation.
Adjustments for overlaps with other Innovation Center
models and CMS programs.
Limits or adjustments to EPM participants' financial
responsibility.
b. Key Terms for EPM Episode Pricing and Payment
For purposes of ease of understanding of the technical discussion
that follows around EPM episode pricing and payment, we are providing
the following definitions of terms that are used in sections that
precede their technical definition and cross-references to other
sections of this proposed rule for more detailed discussion of the
policies associated with these terms.
Anchor hospitalization--hospitalization that initiates an
EPM episode and has no subsequent inpatient-to-inpatient transfer
chained anchor hospitalization.
Chained anchor hospitalization--an anchor hospitalization
that initiates an AMI model episode and has at least one subsequent
inpatient-to-inpatient transfer.
Anchor MS-DRG--MS-DRG assigned to the first
hospitalization discharge, which initiates an EPM episode.
Price MS-DRG--for EPM episodes without a chained anchor
hospitalization, the price MS-DRG is the anchor MS-DRG. For AMI model
episodes with a chained anchor hospitalization, the price MS-DRG is the
MS-DRG assigned to the AMI model episode according to the hierarchy
described in III.D.4.b.(2)(i).
Episode benchmark price--dollar amount assigned to EPM
episodes based on historical EPM-episode data (3 years of historical
Medicare payment data grouped into EPM episodes according to the EPM
episode definitions as discussed in sections III.C.3. and III.C.4. of
this proposed rule) prior to the application of the effective discount
factor, as described throughout sections III.D.4.b through e. of this
proposed rule.
CABG readmission AMI model episode benchmark price--
episode benchmark price assigned to certain AMI model episodes with
price MS-DRG 280-282 or 246-251 and with a readmission for MS-DRG 231-
236, as described in sections III.D.4.b.(2)(c) and III.D.4.e. of this
proposed rule.
Quality-adjusted target price--dollar amount assigned to
EPM episodes as the result of reducing the episode benchmark price by
the EPM participant's effective discount factor based on the EPM
participant's quality performance, as described in sections
III.D.4.b.(10) and III.E.3.f. of this proposed rule.
Excess EPM-episode spending--dollar amount corresponding
to the amount by which actual EPM-episode payments for all EPM episodes
attributed to an EPM participant exceed the quality-adjusted target
prices for the same EPM episodes, as discussed in section III.D.2.c. of
this proposed rule.
2. Performance Years, Retrospective Episode Payments, and Two-Sided
Risk EPMs
a. Performance Period
Consistent with the methodology for the CJR model, we propose 5
performance years (PYs) for the EPMs, which would include EPM episodes
for the periods displayed in the following Table 5:
Table 5--Performance Years for EPMS
------------------------------------------------------------------------
EPM episodes included
Performance year (PY) Calendar year in performance year
------------------------------------------------------------------------
1.............................. 2017 EPM episodes that start
on or after July 1,
2017 and end on or
before December 31,
2017.
2.............................. 2018 EPM episodes that end
between January 1,
2018 and December 31,
2018, inclusive.
3.............................. 2019 EPM episodes that end
between January 1,
2019 and December 31,
2019, inclusive.
4.............................. 2020 EPM episodes that end
between January 1,
2020 and December 31,
2020, inclusive.
5.............................. 2021 EPM episodes that end
between January 1,
2021 and December 31,
2021, inclusive.
------------------------------------------------------------------------
As displayed in Table 5, some EPM episodes that would begin in a
given calendar year may be captured in the following performance year
due to some EPM episodes ending after December 31st of a given calendar
year. For example, EPM episodes beginning in December 2017 and ending
in March 2018 would be part of performance year 2. We believe that the
proposed period of time for the EPMs, which generally aligns with the
performance period for other Innovation Center models, for example, the
CJR and Pioneer ACO models, should be sufficient to test and gather the
data needed to evaluate the EPMs (80 FR 73325). In contrast, we would
be concerned whether an EPM with fewer than 5 performance years would
be sufficient for these purposes.
[[Page 50844]]
We also recognize that our proposal would allow only 6 months of
EPM episodes for PY1 as compared to 9 months for the CJR model. We
considered extending the first PY, for example, to 18 months. As
discussed further in section III.D.2.c. of this proposed rule, however,
we are instead proposing to delay the requirement for participants to
begin accepting downside risk until the second quarter of PY2. As such,
EPM participants would have a comparable transition period to that of
CJR participants with respect to when they must accept downside risk
while still allowing us to make timely reconciliation payments to EPM
participants as well as to most effectively align EPM reconciliation
with the reconciliation processes for other models and programs with
which the EPMs overlap (for example, the Shared Savings Program,
Pioneer ACO model, Comprehensive Primary Care Initiative, and Oncology
Care Model). We believe that it is important to synchronize the timing
of reconciliation for EPMs with other efforts that need this
information when making their financial calculations. We seek comment
on this proposal.
b. Retrospective Payment Methodology
Consistent with the CJR model, we propose to apply a retrospective
payment methodology to the proposed EPMs (80 FR 73329). Under this
proposal, all providers and suppliers caring for Medicare beneficiaries
in EPM episodes would continue to bill and be paid as usual under the
applicable Medicare payment systems. After the completion of an EPM
performance year, Medicare claims for services furnished to EPM
beneficiaries would be grouped into EPM episodes and aggregated, and
EPM participants' actual EPM episode-payments compared to quality-
adjusted target prices (which account for the level of EPM episode
quality), as described in section III.D.5.a. of this proposed rule.
Based on an EPM participant's performance (taking into account quality
and spending), we would determine if Medicare would make a payment to
the participant (reconciliation payment), or if the participant owes
money to Medicare (resulting in Medicare repayment).
We considered an alternative option of paying for EPM episodes
prospectively by paying one lump sum amount to the EPM participant for
the expected spending for the EPM episode which extends 90 days post-
hospital-discharge. However, as was the case when we established
regulations for the CJR model, we continue to believe that such an
option would be challenging to implement at this time given the payment
infrastructure changes for both EPM participants and Medicare that
would need to be developed to pay and manage prospective episode
payments under these EPMs (80 FR 73329). Moreover, we continue to
believe that a retrospective payment approach can accomplish the
objective of testing episode payments in a broad group of hospitals,
including financial incentives to streamline care delivery around that
episode, without requiring core billing and payment changes by
providers and suppliers, which would create substantial administrative
burden.
We seek comment on this proposal.
c. Two-Sided Risk EPMs
As we did for the CJR model, we propose to establish two-sided risk
for hospitals participating in the EPMs. Under this proposal, for each
of performance years 1 through 5, we would make EPM-episode
reconciliation payments to EPM participants that achieve reduced actual
EPM payments relative to their quality-adjusted target prices (80 FR
73229-7333). Likewise, beginning with episodes ending in the second
quarter of performance year 2 and extending through each of performance
years 3 through 5, we would hold EPM participants responsible for
repaying Medicare when their actual EPM-episode payments exceed their
quality-adjusted target prices. As such, our proposal differs from CJR
in that we are proposing a modestly shorter period in which EPM
participants would accept downside risk in order to allow them a
comparable transition period to that of CJR participants in which to do
so. Accordingly, we will refer to the two portions of performance year
2 as--
Performance Year 2 (NDR) or PY2 (NDR) for the first
quarter, that is January 1, 2018 to March 31, 2018, in which EPM
participants assume no downside risk and therefore would have no
Medicare repayment responsibility; and
Performance Year 2 (DR) or PY2 (DR) for the second, third
and fourth quarters, that is April 1, 2018 to December 31, 2018, in
which EPM participants assume downside risk and would have Medicare
repayment responsibility. We believe that our proposal to establish
two-sided risk would provide appropriate incentives for EPM
participants to improve their care quality and efficiency under the
EPMs. We also continue to believe, as we indicated in the CJR Final
Rule, that we would diminish these incentives if we instead proposed to
establish one-sided risk, in which an EPM participant could qualify for
a reconciliation payment but not be held responsible for Medicare
repayments (80 FR 73329). In recognition that EPM participants may need
to make infrastructure, care coordination and delivery, and financial
preparations for the EPMs, which can take several months or longer to
implement, we do believe that it is reasonable to delay EPM participant
responsibility for repaying excess EPM-episode spending in performance
year 1 to more strongly align EPM-participant incentives with care
quality. Thus, similar to what we did for the CJR model, we are
proposing to phase-in this repayment responsibility beginning in the
second quarter of EPM performance year 2 as displayed in Table 6.
We refer to section III.E.3.f. of this proposed rule for additional
information on the effective discount factors used to calculate
quality-adjusted target prices, as well as the quality categories that
determine an EPM participant's effective discount factor that would be
applied to the EPM benchmark episode price at reconciliation to
calculate the repayment amount during the phase-in period in EPM
performance year 2 (quarters 2 through 4) and performance year 3. Table
6 also presents the phase-in of the proposed stop-loss limits and
discount percentages, which are discussed in detail in section
III.D.7.b. and III.D.4.b.(10) of this proposed rule.
We seek comment on this proposal.
Table 6--Stop-Loss Thresholds and Discount Percentage Ranges for Medicare Repayments by PY
--------------------------------------------------------------------------------------------------------------------------------------------------------
PY1 PY2 (NDR) PY2 (DR) % PY3 % PY4 % PY5 %
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stop-loss threshold..................................... n/a as no downside risk in PY1 5 10 20 20
and PY2 (DR)
[[Page 50845]]
Discount percentage (range) for Repayment, Depending on 0.5-2.0 0.5-2.0 1.5-3.0 1.5-3.0
Quality Category.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Stop-loss thresholds for certain hospitals, including rural and sole-community hospitals are 3% for PY2 (DR) and 5% for PY3-PY5.
3. Adjustments to Actual EPM-Episode Payments and to Historical Episode
Payments Used to Set Episode Prices
a. Overview
We propose to calculate actual EPM-episode payments and historical
episode payments (3 years of historical Medicare payment data grouped
into EPM episodes according to the EPM episode definitions as discussed
in sections III.C.3. and III.C.4. of this proposed rule) to calculate
EPM quality-adjusted target prices for each performance year of the
EPMs as we did for the CJR model--that is, for each non-cancelled EPM
episode, we would calculate these amounts based on Medicare payments
for Parts A and B claims for services included in the EPM episode
definition. As was the case for the CJR model, we also propose to
include certain payment adjustments in the EPMs for: (1) Special
payment provisions under existing Medicare payment systems; (2)
payments for services that straddle episodes; and (3) high payment
episodes (80 FR 73330 through 73336). We also propose to additionally
include an adjustment for reconciliation payments and Medicare
repayments when updating EPM participant episode benchmark and quality-
adjusted target prices (80 FR 73330 through 73331). We refer to section
III.D.6. of this proposed rule for discussion of adjustments for
overlaps with other Innovation Center models and CMS programs.
b. Special Payment Provisions
Many of the existing Medicare payment systems have special payment
provisions that have been created by regulation or statute to improve
quality and efficiency in service delivery. IPPS hospitals are subject
to incentives under the HRRP, the HVBP Program, the Hospital-Acquired
Condition (HAC) Reduction Program, and the HIQR Program and Outpatient
Quality Reporting (OQR) Program. IPPS hospitals and CAHs are subject to
the Medicare Electronic Health Record (EHR) Incentive Program.
Additionally, the majority of IPPS hospitals receive additional
payments for Medicare Disproportionate Share Hospital (DSH) and
Uncompensated Care, and IPPS teaching hospitals can receive additional
payments for Indirect Medical Education (IME). IPPS hospitals that meet
certain requirements related to low volume Medicare discharges and
distance from another hospital receive a low volume add-on payment.
Also, some IPPS hospitals qualify to be sole community hospitals (SCHs)
or Medicare Dependent Hospitals (MDHs), and they may receive enhanced
payments based on cost-based hospital-specific rates for services;
whether a SCH or MDH receives enhanced payments may vary year to year,
in accordance with Sec. 419.43(g) and Sec. 412.108(g), respectively.
Medicare payments to providers of post-acute care services,
including IRFs, SNFs, IPFs, HHAs, LTCHs, and hospice facilities, are
conditioned, in part, on whether the provider satisfactorily reports
certain specified data to CMS: Inpatient Rehabilitation Facility
Quality Reporting Program (IRF QRP); Skilled Nursing Facility Quality
Reporting Program (SNF QRP); Inpatient Psychiatric Facility Quality
Reporting Program (IPF QRP); Home Health Quality Reporting Program (HH
QRP); Long-Term Care Hospital Quality Reporting Program (LTCH QRP); and
Hospice Quality Reporting Program. Additionally, IRFs located in rural
areas receive rural add-on payments, IRFs serving higher proportions of
low-income beneficiaries receive increased payments according to their
low-income percentage (LIP), and IRFs with teaching programs receive
increased payments to reflect their teaching status. SNFs receive
higher payments for treating beneficiaries with human immunodeficiency
virus (HIV). HHAs located in rural areas also receive rural add-on
payments.
Ambulatory Surgical Centers (ASCs) have their own Quality Reporting
Program (ASC QRP). Physicians also have a set of special payment
provisions based on quality and reporting: Medicare EHR Incentive
Program for Eligible Professionals; Physician Quality Reporting System
(PQRS); and Physician Value-based Modifier Program.
Consistent with how we determine payments under the CJR model, we
propose to adjust both the actual and historical EPM-episode payments
used to set EPM-episode benchmark and quality-adjusted target prices by
excluding these special payments from EPM-episode calculations using
the CMS Price Standardization methodology (80 FR 73333). We believe
that in applying this methodology to exclude these payments from our
calculations, we would best maintain appropriate incentives for both
the proposed EPMs and the existing incentive programs. Also, not
excluding add-on payments based on the characteristics of providers
caring for EPM beneficiaries, such as more indigent patients, having
low Medicare hospital volume, being located in a rural area, supporting
greater levels of physician training, and having a greater proportion
of beneficiaries with HIV, from actual EPM-episode payments could
inappropriately result in certain EPM participants that receive more
add-on payments having worse episode payment performance compared to
quality-adjusted target prices than what their performance would
otherwise have been. Additionally, not excluding enhanced payments for
MDHs and SCHs could result in higher or lower quality-adjusted target
prices just because EPM participants received their enhanced payments
in 1 historical year but not the other, regardless of actual
utilization. We also believe that excluding special payments would
ensure an EPM participant's actual episode payment performance is not
artificially improved or worsened because of payment reduction
penalties or incentives or enhanced or add-on payments, the effects of
which we are not intending to test under the proposed models. In
addition to the various incentives, enhanced payments, and add-on
payments, sequestration came into effect for Medicare payments for
discharges on or after April 1, 2013, per the Budget Control Act of
2011 and delayed by the American Taxpayer Relief Act of 2012.
Sequestration applies a 2-percent
[[Page 50846]]
reduction to Medicare payment for most Medicare FFS services.
For more information on the CMS Price (Payment) Standardization
Detailed Methodology, we refer to the QualityNet Web site at http://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier4&cid=1228772057350 and to 80 FR 73331.
Accordingly, we propose to exclude these special payments from EPM-
episode calculations using the CMS Price Standardization methodology at
Sec. 512.300(e)(2). We seek comment on our proposal to exclude special
payments using the CMS Price Standardization methodology.
c. Services That Straddle Episodes
A service that straddles an EPM episode is one that begins before
the start of or continues beyond the end of an EPM episode that extends
90 days post-hospital discharge. Under the CJR model, we prorate
payments so that they include only the portion of the payment that is
included in the CJR model episode, using separate approaches to prorate
payments under each payment system, for example, IPPS, non-IPPS and
other inpatient services, and home health services (80 FR 73333 through
73335). We propose to apply the CJR model methodologies for prorating
payments when calculating actual EPM-episode payments and when
calculating historical EPM-episode payments used to set EPM-episode
benchmark and quality-adjusted target prices. We believe these
methodologies would most accurately account for spending within EPM
episodes under the proposed EPMs.
The proposed methodologies for prorating payments are included in
Sec. 512.300(f). We seek comment on our proposed methodologies for
prorating payments.
d. High-Payment EPM Episodes
For the CJR model, we defined a high-payment episode as an episode
with payments 2 standard deviations or more above the mean calculated
at the regional level (80 FR 73336 through 73337). As with the CJR
model, we propose applying a high-payment episode ceiling when
calculating actual EPM-episode payments and when calculating historical
EPM-episode payments used to set EPM-episode benchmark and quality-
adjusted target prices. We propose to apply the ceiling according to
the following groupings that align with our proposed EPM price-setting
methodology.
First, for SHFFT model episodes, we propose to calculate and apply
the ceiling separately for each SHFFT price MS-DRG at the regional
level.
Second, for AMI model episodes with price MS-DRGs 280-282 or 246-
251 without readmission for CABG MS-DRGs, we propose to calculate and
apply the ceiling separately for each price MS-DRG at the regional
level.
Third, for CABG model episodes, we propose to apply ceilings
separately to the payments that occurred during the anchor
hospitalization of the CABG model episode and to the payments that
occurred after the anchor hospitalization. For the anchor
hospitalization portion of CABG model episodes, we propose to calculate
and apply the ceiling separately by each price MS-DRG in 231-236 at the
regional level. For the post-anchor hospitalization portion we propose
to calculate and apply the ceiling separately for the following
groupings at the regional level:
With AMI ICD-CM diagnosis code on the anchor inpatient
claim and price MS-DRG with major complication or comorbidity (231,
233, or 235).
With AMI ICD-CM diagnosis code on the anchor inpatient
claim and price MS-DRG without major complication or comorbidity (232,
234, or 236).
Without AMI ICD-CM diagnosis code on the anchor inpatient
claim and price MS-DRG with major complication or comorbidity (231,
233, or 235).
Without AMI ICD-CM diagnosis code on the anchor inpatient
claim and price MS-DRG without major complication or comorbidity (232,
234, or 236).
Fourth, for AMI model episodes with price MS-DRG 231-236, we
propose to apply ceilings separately to the payments that occurred
during the chained anchor hospitalization and to the payments that
occurred after the chained anchor hospitalization. For the anchor
hospitalization portion of the episode, we propose to apply the
regional level ceiling calculated for the anchor hospitalization
portion of a CABG model episode for the corresponding price MS-DRG, as
described previously. For the post-anchor hospitalization portion of
the episode, we propose to apply the regional level ceiling calculated
for the post-anchor hospitalization portion of a CABG model episode for
the corresponding price MS-DRG with AMI diagnosis.
Fifth, for AMI model episodes with price MS-DRG 280-282 or 246-251
and with readmission for CABG MS-DRGs, we propose to apply the ceiling
separately to the payments during the CABG readmission and all other
payments during the episode. For payments during the CABG readmission
portion of the AMI model episode we propose to apply the regional level
ceiling calculated for the anchor hospitalization portion of a CABG
model episode for the corresponding CABG readmission MS-DRG, as
described previously. For all other payments during the AMI model
episode, we propose to apply the regional level ceiling calculated for
AMI model episodes with price MS-DRG 280-282 or 246-251 and without
readmission for CABG MS-DRGs corresponding to the AMI price MS-DRG.
We believe that this ceiling would protect EPM participants from
variable repayment risk for especially-high payment EPM episodes where
the clinical scenarios for these cases each year may differ
significantly and unpredictably.
The proposal for capping high payment EPM episodes is included in
Sec. 512.300(e)(1). We seek comment on our proposal to cap high
payment EPM episodes.
e. Treatment of Reconciliation Payments and Medicare Repayments When
Calculating Historical EPM-Episode Payments To Update EPM-Episode
Benchmark and Quality-Adjusted Target Prices
For the CJR model, we exclude CJR model reconciliation payments and
Medicare repayments from the expenditure data used to update historical
claims when calculating CJR model target prices, although we received
comments on the proposed rule encouraging us to include these payments.
For example, commenters supported their inclusion because CJR-
participating hospitals otherwise would be providing care coordination
services that would not be paid directly or accounted for under
applicable Medicare FFS payments systems and thus might be funded
through reconciliation payments. Further, by excluding reconciliation
payments from our calculations, commenters suggested that we may
underestimate their actual resource costs when updating target prices
for the care necessary during episodes. The CJR Final Rule discussed
our view that including reconciliation payments would have the effect
of Medicare paying CJR model participant hospitals their target prices,
regardless of whether such participant was below, above, or met their
episode target price. We also noted that we had not discussed any
alternatives in the CJR model proposed rule, and that we might
[[Page 50847]]
consider including these payments in updating historical claims through
future rulemaking (80 FR 73332).
After further consideration, we are proposing to include both
reconciliation payments and Medicare repayments when calculating
historical EPM-episode payments to update EPM-episode benchmark and
quality-adjusted target prices. We concur with the views expressed by
commenters on the CJR model proposed rule that including these payments
would more fully recognize the total resource costs of care under an
EPM than would their exclusion. As indicated in section V.5 of this
proposed rule, we are also proposing to modify our policy for the CJR
model to also include reconciliation payments and Medicare repayments
when updating target prices under that model We also considered an
option where we would include only reconciliation payments when
updating but not Medicare repayments; however, we believe this option
would not achieve our intention of more fully capturing the costs of
care under the EPM. We would further note that the inclusion of both
reconciliation payments and Medicare repayments could have differential
effects on an EPM participant's benchmark and quality-adjusted target
prices based on whether or not it received a reconciliation payment or
made a Medicare repayment. For example, all else equal, including an
EPM reconciliation payment when updating an EPM participant's EPM-
episode benchmark and quality-adjusted target prices would modestly
increase the quality-adjusted target prices in performance years 3
through 5 in comparison to not including the reconciliation payment.
Conversely, all else equal, including a Medicare repayment when
updating an EPM participant's EPM-episode benchmark and quality-
adjusted target prices would reduce the next performance year's
quality-adjusted target price in comparison to not including the
Medicare repayment.
Following analogous logic, we also propose to include BPCI Net
Payment Reconciliation Amounts in our calculations when updating EPM-
episode benchmark and quality-adjusted target prices. We would note,
however, that the effects of these proposals would largely be confined
to PY3 of the EPMs and diminish as EPM-participant historical EPM-
episode updates are eventually determined based on regional payments in
subsequent years of the EPMs. This is because the net sum of EPM
reconciliation payments, Medicare repayments, and BPCI Net Payment
Reconciliation Amounts would represent a small portion of the total
historical EPM-episode payments captured in regional pricing.
When updating EPM-episode benchmark and quality adjusted target
prices for CABG model episodes, we propose to apportion EPM
reconciliation payments and BPCI Net Reconciliation Payment Amounts
proportionally to the anchor hospitalization and post-anchor
hospitalization portions of CABG model historical episodes. We also
propose to calculate the proportions based on regional average
historical episode payments that occurred during the anchor
hospitalization portion of CABG model episodes and regional average
historical episode payments that occurred during the post-anchor anchor
hospitalization portion of CABG model episodes that were initiated
during the 3 historical years. This aligns with the general proposal to
calculate the CABG model-episode benchmark price as the sum of the
corresponding CABG anchor hospitalization benchmark price and the
corresponding CABG post-anchor hospitalization benchmark price, as
discussed in III.D.4.b.(2)(ii) and III.D.4.d. of this proposed rule.
The proposal to include both reconciliation payments and Medicare
repayments when calculating historical EPM-episode payments to update
EPM-episode benchmark and quality-adjusted target prices is included in
Sec. 512.300(c)(8). We seek comment on our proposal to include both
reconciliation payments and Medicare repayments when calculating
historical EPM-episode payments to update EPM-episode benchmark and
quality-adjusted target prices.
4. EPM-Episode Price-Setting Methodologies
a. Overview
Whether an EPM participant receives a reconciliation payment or is
made responsible to repay Medicare under the proposed EPM is based on
the EPM participant's actual EPM-episode payments relative to quality-
adjusted target prices, as well as the EPM participant's eligibility
for reconciliation payment based on acceptable, good, or excellent
quality performance. While our proposals for relating EPM participant
quality performance to EPM payments are further discussed in section
III.E.3.f of this proposed rule, the remainder of this section will
discuss the proposed approach to establishing EPM-episode benchmark and
quality-adjusted target prices.
For the purposes of price-setting, any references in this proposed
rule to AMI ICD-CM diagnosis codes means those ICD-9-CM and ICD-10-CM
diagnosis codes for historical EPM episodes or ICD-10-CM diagnosis
codes for EPM episodes during the EPM performance years that can be
found in the specific EPM episode definitions parameters spreadsheet.
Also, for the purposes of price-setting, any references in this
proposed rule to intracardiac ICD-CM procedure codes means those ICD-9-
CM procedure codes for historical EPM episodes that can be found in the
specific EPM episode definitions parameters spreadsheet. The EPM
episode definitions parameters spreadsheets are posted on the CMS Web
site at https://innovation.cms.gov/inititatives/epm.
We propose to establish EPM-episode benchmark and quality-adjusted
target prices for each EPM participant based on the following MS-DRGs
and diagnoses included in the AMI, CABG, and SHFFT models as discussed
in sections III.C.3 and III.C.4. of this proposed rule:
(1) AMI Model
AMI MS-DRGs--
++ 280 (Acute myocardial infarction, discharged alive with MCC);
++ 281 (Acute myocardial infarction, discharged alive with CC);
++ 282 (Acute myocardial infarction, discharged alive without CC/
MCC); and
PCI MS-DRGs, when the claim includes an AMI ICD-CM
diagnosis code in the principal or secondary position on the inpatient
claim and when the claim does not include an intracardiac ICD-CM
procedure code in any position on the inpatient claim--
++ 246 (Perc cardiovasc proc with drug-eluting stent with MCC or 4+
vessels/stents);
++ 247 (Perc cardiovasc proc with drug-eluting stent without MCC);
++ 248 (Perc cardiovasc proc with non-drug-eluting stent with MCC
or 4+ vessels/stents);
++ 249 (Perc cardiovasc proc with non-drug-eluting stent without
MCC);
++ 250 (Perc cardiovasc proc without coronary artery stent with
MCC); and
++ 251 (Perc cardiovasc proc without coronary artery stent without
MCC).
(2) CABG Model DRGs--
231 (Coronary bypass with PTCA with MCC);
232 (Coronary bypass with PTCA without MCC);
233 (Coronary bypass with cardiac cath with MCC);
234 (Coronary bypass with cardiac cath without MCC);
[[Page 50848]]
235 (Coronary bypass without cardiac cath with MCC); and
236 (Coronary bypass without cardiac cath without MCC).
(3) SHFFT Model DRGs--
480 (Hip and femur procedures except major joint with
MCC);
481 (Hip and femur procedures except major joint with CC);
and
482 (Hip and femur procedures except major joint without
CC or MCC).
We propose to generally apply the CJR model methodology to set EPM-
episode benchmark and quality-adjusted target prices, with the addition
of some adjustments based on the specific clinical conditions and care
patterns for EPM episodes included in the AMI, CABG, and SHFFT models
(80 FR 73337 through 73338). The proposed price-setting methodology
incorporates the following features:
Set different EPM benchmark and quality-adjusted target
prices for EPM episodes based on the assigned price MS-DRG in one of
the included MS-DRGs to account for patient and clinical variations
that impact EPM participants' costs of providing care. Inpatient claims
with PCI MS-DRGs 246-251 that contain an intracardiac ICD-CM procedure
code in any position would not anchor an historical episode, nor be
considered when assigning a price MS-DRG. This is because beginning in
FY 2016, inpatient claims containing an intracardiac ICD-10-CM
procedure code in any position no longer map to MS-DRGs 246-251.
Adjust EPM benchmark and quality-adjusted target prices
for certain EPM episodes involving chained anchor hospitalizations,
specific readmissions, or the presence of an AMI ICD-CM diagnosis code
for CABG MS-DRGs.
Use 3 years of historical Medicare FFS payment data
grouped into EPM episodes according to the EPM episode definitions in
sections III.C.3 and III.C.4. of this proposed, termed historical EPM
episodes and historical EPM-episode payments. The specific set of 3
historical years would be updated every other performance year.
Apply Medicare payment system (for example, IPPS, OPPS,
IRF PPS, SNF, MPFS.) updates to the historical EPM-episode data to
ensure we incentivize EPM participants based on historical utilization
and practice patterns, not Medicare payment system rate changes that
are beyond such participants' control. Because different Medicare
payment system updates become effective at two different times of the
year, we would calculate one set of EPM-benchmark and quality-adjusted
target prices for EPM episodes initiated between January 1 and
September 30 and another set for EPM episodes initiated between October
1 and December 31.
Blend together EPM-participant hospital-specific and
regional historical EPM-episode payments, transitioning from primarily
hospital-specific to completely regional pricing over the course of the
5 performance years, to incentivize both historically-efficient and
less-efficient EPM participants to furnish high quality, efficient care
in all years of the EPM Regions would be defined as each of the nine
U.S. Census divisions.
Normalize for hospital-specific wage-adjustment variations
in Medicare payment systems when combining hospital-specific and
regional historical EPM episodes.
Pool together EPM episodes by groups of price MS-DRGs to
allow a greater volume of historical cases and allow us to set more
stable prices.
Apply an effective discount factor on EPM-episode
benchmark prices to serve as Medicare's portion of reduced expenditures
from the EPM episode, with any remaining portion of reduced Medicare
spending below the quality-adjusted target price potentially available
as reconciliation payments to the EPM participant where the anchor
hospitalization occurred.
Further discussion on each of the proposed features and
sequential steps to calculate EPM-episode benchmark and quality-
adjusted target prices can be found in sections III.D.4.b through e. of
this proposed rule, which immediately follow.
We also propose to calculate and communicate EPM-episode benchmark
and quality-adjusted target prices to EPM participants prior to the
performance period in which the prices apply (that is, prior to January
1, 2018, for prices covering EPM episodes that start between January 1,
2018, and September 30, 2018; prior to October 1, 2018, for prices
covering EPM episodes that start between October 1, 2018, and December
31, 2018). We believe that prospectively communicating EPM-episode
benchmark and quality-adjusted target prices to EPM participants would
help them make infrastructure, care coordination and delivery, and
financial refinements they may deem appropriate to prepare for the new
episode target prices under the model.
The proposal to prospectively communicate quality-adjusted target
prices are included in Sec. 512.300(c)(9). We seek comment on our
proposal to prospectively communicate these prices.
b. EPM-Episode Benchmark and Quality-Adjusted Target Price Features
(1) Risk-Stratifying EPM-Episode Benchmark Prices Based on MS-DRG and
Diagnosis
To account for some of the clinical and resource variations that
would be expected to occur under the EPMs, we propose generally to
apply the episode pricing methodology that was applied to the CJR model
to develop the EPM-episode benchmark prices, hereinafter called the
standard EPM-episode benchmark price. In addition, for each EPM
participant, we propose to risk-stratify and establish special EPM-
episode benchmark prices for episodes in different pricing scenarios as
described in this section, as well as sections III.D.4.c. through e. of
this proposed rule. For purposes of this proposed rule, risk-
stratification means the methodology for developing the EPM-episode
benchmark price that accounts for clinical and resource variation in
historical EPM episodes so that the quality-adjusted target price
(calculated from the EPM-episode benchmark price) can be compared to
actual EPM episode payments for EPM beneficiaries with similar care
needs to those in historical EPM episodes.
For the SHFFT model, we propose to set the price MS-DRG equal to
the anchor MS-DRG. We propose to calculate standard SHFFT model-episode
benchmark prices based on price MS-DRGs following the general payment
methodology that was applied to the CJR model with risk stratification
according to the anchor MS-DRG (80 FR 73337 through 73358).
Similarly, for AMI model episodes without chained anchor
hospitalizations and without readmissions for CABG MS-DRGs, we propose
to set the price MS-DRG equal to the anchor MS-DRG. We propose to
calculate standard AMI model-episode benchmark prices based on price
MS-DRGs following the general payment methodology that was applied to
the CJR model with risk stratification according to the anchor MS-DRG
(80 FR 73337 through 73358). We propose to apply the CJR model payment
methodology separately to AMI model episodes with anchor AMI MS-DRGs
280-282 and anchor PCI MS-DRGs 246-251 with a corresponding AMI ICD-CM
diagnosis code on the inpatient claim for the anchor hospitalization
and without an intracardiac ICD-CM procedure code in any position on
the inpatient claim for the anchor hospitalization.
For episodes in the AMI model with chained anchor hospitalizations
and no readmissions for CABG MS-DRGs, we
[[Page 50849]]
propose to set the price MS-DRG based on the hierarchy described in
section III.D.4.b.(2)(a) and to calculate AMI model-episode benchmark
prices based on price MS-DRGs as described in sections III.D.4.b.(2)(a)
and III.D.4.c. of this proposed rule.
For AMI model episodes without chained anchor hospitalizations and
with readmissions for CABG MS-DRGs, we propose to set the price MS-DRG
as the anchor MS-DRG and to calculate CABG readmission AMI model-
episode benchmark prices as described in sections III.D.4.b.(2)(b),
III.D.4.b.(2)(c), and III.D.4.e of this proposed rule.
For AMI model episodes with chained anchor hospitalizations that do
not include CABG MS-DRGs and with readmissions for CABG MS-DRGs, we
propose to set the price MS-DRG based on the hierarchy described in
section III.D.4.b.(2)(a) and to calculate CABG readmission AMI model-
episode benchmark prices as described in sections III.D.4.b.(2)(b),
III.D.4.b.(2)(c), and III.D.4.e. of this proposed rule.
For CABG model episodes, we propose to set the price MS-DRG as the
anchor MS-DRG and to calculate CABG model-episode benchmark prices as
the sum of the CABG anchor hospitalization portion price and the CABG
post-anchor hospitalization portion price, which would be calculated by
applying the general payment methodology that was applied to the CJR
model separately to the expenditures that occurred during the anchor
hospitalization of the CABG model episode and to the expenditures that
occurred after the anchor hospitalization as discussed in sections
III.D.4.b.(2)(b) and III.D.4.d. of this proposed rule (80 FR 73337
through 73358).
Finally, we propose that after assigning an EPM-episode benchmark
price to each EPM episode, the EPM-episode quality-adjusted target
price would be the EPM-episode benchmark price reduced by the effective
discount factor for the corresponding EPM that corresponds to the EPM
participant's quality category, as discussed in sections III.D.4.b.(10)
and III.E.3.f. of this proposed rule.
(2) Adjustments To Account for EPM-Episode Price Variation
We also have considered further adjustments to account for clinical
and resource variation that could affect EPM participants' costs for
EPM episodes. As was the case for the CJR model, we continue to believe
that no standard risk adjustment approach that is widely-accepted
throughout the nation exists for the proposed EPM episodes (80 FR 73338
through 73339). Thus, we are not proposing to make risk adjustments
based on beneficiary-specific demographic characteristics or clinical
indicators. Likewise, we continue to believe that CMS Hierarchical
Condition Categories (HCC) used to adjust for risk in the Medicare
Advantage program would not be appropriate for risk-adjusting EPM
episodes as such categories are used to predict total Medicare
expenditures in an upcoming year for MA plans and may not be
appropriate for use in predicting expenditures over a shorter period of
time, such as the EPM episodes. Further, the validity of HCC scores for
predicting Medicare expenditures for shorter episodes-of-care or
specifically for the AMI, CABG, and SHFFT model episodes that we are
proposing has not been determined. Thus, we do not propose to risk-
adjust EPM-episode benchmark or quality-adjusted target prices using
HCC scores for the currently proposed EPMs. We refer to the CJR Final
Rule for additional discussion of our assessment of risk-adjustment
options for the CJR model, which informs our views on their
appropriateness for the proposed EPMs (80 FR 73338 through 73340).
However, we believe there are circumstances that could account for
spending variation in EPM episodes where certain pricing adjustments
could be appropriate. We have identified several scenarios where
increased EPM-episode efficiencies would be limited for certain groups
of EPM beneficiaries and a standard EPM-episode benchmark price based
on the anchor MS-DRG would, therefore, not account for circumstances
where clinically-appropriate care could consistently result in higher
EPM-episode payments. For example, as discussed in section
III.C.4.a.(5) of this proposed rule, variation could arise from the
asymmetric distribution of cardiac care across hospitals, which makes
transfers, either from a hospitalization or from the emergency
department (without inpatient admission) of one hospital to another, a
common consideration in the treatment course for beneficiaries with an
initial diagnosis of AMI, resulting in a chained anchor hospitalization
for inpatient-to-inpatient transfers. Alternately, we recognize that
certain episodes involving hospital readmissions for clinically-
appropriate planned follow-up care may have higher episode spending
than episodes with a single hospitalization or with chained anchor
hospitalizations involving transfers that do not have any readmissions.
Further, a beneficiary who has a CABG in the context of hospitalization
for an AMI may have different spending in the 90 days post-hospital-
discharge due to different health needs than a beneficiary who has an
elective CABG. Accordingly, we propose specific policies and payment
adjustments in recognition of the systematic, consistent variation in
EPM-episode spending that could result from such circumstances.
(a) Adjustments for Certain AMI Model Episodes With Chained Anchor
Hospitalizations
In section III.C.4.a.(5) of this proposed rule, we proposed that
once an AMI model episode is initiated at an AMI model participant, the
AMI model episode continues under the responsibility of that specific
participant, regardless of whether the beneficiary is transferred to
another hospital for further medical management of AMI or
revascularization through PCI or CABG during a chained anchor
hospitalization. Given there could be significant differences between
the discharge MS-DRG from the hospital that initiates the AMI episode
and the hospital to which a beneficiary is transferred, as well as the
Medicare payment associated with these different MS-DRGs and the post-
discharge spending for these beneficiaries, we believe it would be
appropriate to adjust the AMI model-episode benchmark prices for
certain AMI model episodes involving a chained anchor hospitalization.
More specifically, we believe that it would be appropriate to make
an adjustment when a final hospital discharge MS-DRG in the chained
anchor hospitalization is an anchor MS-DRG under either the AMI or CABG
model. Thus, for episodes involving a chained anchor hospitalization
with a final discharge diagnosis of any of AMI MS-DRG 280-282, PCI MS-
DRG 246-251 without an intracardiac ICD-CM procedure code in any
position on the inpatient claim, or CABG MS-DRG 231-236, we propose to
set a chain-adjusted AMI model-episode benchmark price or ``price MS-
DRG'' based on the AMI, PCI, or CABG MS-DRG in the chained anchor
admission with the highest IPPS weight. If a CABG MS-DRG occurs in a
chained anchor hospitalization that was initiated with an AMI MS-DRG or
PCI MS-DRG without an intracardiac ICD-CM procedure code in any
position on the corresponding inpatient claim, we propose that the AMI
model episode would begin with and be attributed to the first hospital,
and we propose to set the price MS-DRG to the CABG MS-DRG in the
chained anchor
[[Page 50850]]
hospitalization with the highest IPPS weight.
If the price MS-DRG is an AMI or PCI MS-DRG, we propose to set the
episode benchmark price as the standard AMI model-episode benchmark
price for the price MS-DRG, subject to a possible adjustment for
readmission for CABG MS-DRGs, as described in section III.D.4.b.(2)(c)
of this proposed rule. If the price MS-DRG is a CABG MS-DRG, we propose
to set the AMI model-episode benchmark price as the CABG model-episode
benchmark price for the corresponding CABG MS-DRG, with no further
adjustment in the event of a readmission for CABG MS-DRGs.
Table 7 displays the weights for CABG, PCI, and AMI MS-DRGs
established in the FY 2016 IPPS final rule, which are subject to change
each FY through the annual IPPS rulemaking (80 FR 49325 through 49886).
Table 7--FY 2016 IPPS Weights for MS-DRGS 231-236, 246-251, and 280-282
------------------------------------------------------------------------
MS-DRG MS-DRG title Weights
------------------------------------------------------------------------
231.......................... CORONARY BYPASS W PTCA W 7.8056
MCC.
232.......................... CORONARY BYPASS W PTCA W/ 5.7779
O MCC.
233.......................... CORONARY BYPASS W CARDIAC 7.3581
CATH W MCC.
234.......................... CORONARY BYPASS W CARDIAC 4.9076
CATH W/O MCC.
235.......................... CORONARY BYPASS W/O 5.8103
CARDIAC CATH W MCC.
236.......................... CORONARY BYPASS W/O 3.8013
CARDIAC CATH W/O MCC.
246.......................... PERC CARDIOVASC PROC W 3.2494
DRUG-ELUTING STENT W MCC
OR 4+ VESSELS/STENTS.
247.......................... PERC CARDIOVASC PROC W 2.1307
DRUG-ELUTING STENT W/O
MCC.
248.......................... PERC CARDIOVASC PROC W 3.0696
NON-DRUG-ELUTING STENT W
MCC OR 4+ VES/STENTS.
249.......................... PERC CARDIOVASC PROC W 1.9140
NON-DRUG-ELUTING STENT W/
O MCC.
250.......................... PERC CARDIOVASC PROC W/O 2.6975
CORONARY ARTERY STENT W
MCC.
251.......................... PERC CARDIOVASC PROC W/O 1.6863
CORONARY ARTERY STENT W/
O MCC.
280.......................... ACUTE MYOCARDIAL 1.6971
INFARCTION, DISCHARGED
ALIVE W MCC.
281.......................... ACUTE MYOCARDIAL 1.0232
INFARCTION, DISCHARGED
ALIVE W CC.
282.......................... ACUTE MYOCARDIAL 0.7557
INFARCTION, DISCHARGED
ALIVE W/O CC/MCC.
------------------------------------------------------------------------
We believe that this proposal could minimize potential
disincentives to AMI model participants from transferring patients when
different or higher levels of care are needed. This is because the AMI
model-episode benchmark prices we set would be more representative of
the AMI spending based on the totality of care furnished during the
chained anchor hospitalization and post-discharge period within the AMI
model episode and for which the AMI model participants would be held
accountable. We also believe that our proposal could encourage AMI
model participants that frequently transfer patients after admission to
improve their efficiency and the quality of care by transferring
beneficiaries needing higher levels of care prior to hospital admission
and managing those beneficiaries admitted to reduce the need for later
transfers.
As an alternative, we also considered an approach where we would
set the target price taking into consideration IPPS payments for both
the MS-DRG assigned to the first admission in the chained anchor
hospitalization and the MS-DRG assigned to the final admission in the
chained anchor hospitalization. We could apply this approach to all AMI
model participant hospitals or to only a subset of hospitals based on
special situations that could lead to more common transfer scenarios
that are unavoidable, such as small bed-size, rural location,
interventional or cardiac surgery capacity, or other characteristic of
the hospitals. All AMI model episodes involving chained anchor
hospitalizations would include at least two IPPS payments for the
chained anchor hospitalization, compared to one IPPS payment for most
AMI episodes with only an anchor hospitalization that does not result
in an inpatient-to-inpatient transfer. The alternative approach would
likely result in a higher AMI-model episode benchmark price than under
our proposal for AMI model episodes including a chained anchor
hospitalization. Therefore, we believe this alternative approach could
have the effect of further reducing potential disincentives to
hospitals from transferring patients when different or a higher level
of care is needed; however, we are not convinced this approach would
ultimately improve care quality and efficiency under the AMI model.
First, we are concerned that this alternative approach could serve
as an incentive for hospitals to admit and then transfer patients when
doing so might not be medically necessary, which would neither enhance
care quality nor efficiency. A recent study showed that non-procedure
hospitals, defined as hospitals that lack onsite cardiac
catheterization and coronary revascularization facilities, vary
substantially in their use of the transfer process for Medicare
beneficiaries admitted with AMI.\61\ Beneficiaries transferred from
hospitals that had a high transfer rate experienced greater use of
invasive cardiac procedures after admission to the transfer hospital
than beneficiaries transferred from hospitals with a low transfer rate.
However, higher transfer rates were not associated with a significantly
lower risk-standardized mortality rate at 30 days, and at one year,
there was only a 1.1 percent mortality rate difference between
hospitals with higher and lower transfer rates. As such, we believe
this alternative approach could be appropriate for only a subset of AMI
model participant hospitals based on specific hospital characteristics
that could lead to a higher frequency of unavoidable transfers for AMI
model beneficiaries rather than appropriate for hospitals overall. In
addition, if we were to adopt this alternative approach, we believe it
would also be necessary to incorporate methods for monitoring changes
in the frequency of AMI model participant hospital patient transfers
over the model's performance years, as well as assessing the
appropriateness of those transfers. For example, to address changes in
transfer frequency, we might compare how often an AMI model participant
hospital transferred a beneficiary following an inpatient admission
within each performance year relative to the frequency of transfers
during its initial 3-year historical period. To address
[[Page 50851]]
appropriateness of transfers, we might consider reviewing and comparing
a sample of a hospital's transfers within a performance year as
compared to the historical period. Furthermore, we might also propose
future changes to this approach where changes in the frequency or
appropriateness of transfers were identified.
---------------------------------------------------------------------------
\61\ Barreto-Filho J, Wang Y, Rathore SS et al. Transfer Rates
From Nonprocedure Hospitals After Initial Admission and Outcomes
Among Elderly Patients With Acute Myocardial Infarction. JAMA Intern
Med. 2014;174(2):213-222. doi:10.1001/jamainternmed.2013.11944.
---------------------------------------------------------------------------
Second, in contrast to our proposal, we believe that this
alternative approach would not have the benefit of encouraging AMI
model participant hospitals to make an early decision and transfer
patients prior to rather than following inpatient admission when doing
so prior to admission would be appropriate for the beneficiary's
clinical circumstances and the hospital's capabilities. While we
recognize that in some cases, an AMI model beneficiary admitted to the
initial treating hospital may need to be transferred to a referral
hospital that can provide a different or higher level of care, we
believe it is important that the AMI model's payment methodology
support the goal of rapid decision-making by the AMI model participant
hospital about the AMI model beneficiary's care pathway based on
clinical guidelines that often incorporate a time dimension in the
guidelines for care.
Thus, on balance, we believe our proposed methodology would best
establish appropriate incentives to improve care quality and efficiency
under the AMI model by encouraging timely decisions about admission to
the initial treating hospital and incentivizing only those transfers
that are necessary to meet AMI model beneficiary's health care during
the course of their hospitalization. Our proposal would adjust the AMI
model-episode benchmark price that applies to the episode when a
chained anchor hospitalization occurs and results in more costly care
at the transfer hospital than would be expected based on the anchor MS-
DRG at the initial treating hospital who would be accountable for the
episode under the AMI model, thus accounting for the care at the
referral hospital.
In contrast, some chained anchor hospitalizations could begin an
episode based on an MS-DRG that anchors an episode in the model such as
an AMI MS-DRGs that subsequently also includes an MS-DRG that does not
anchor an episode under the model (for example, heart failure, renal
failure, or cardiac valve replacement). Some of these non-anchor MS-
DRGs could be related to the AMI episode but are unavoidable, for
example, cardiac valve surgery, while others could potentially reflect
complications resulting from inadequate care management during the
episode (for example, heart or renal failure).
As discussed in section III.C.4.b. of this proposed rule, we
propose to cancel an AMI model episode when the final MS-DRG in a
chained anchor hospitalization is from an MS-DRG that would not an
anchor MS-DRG under the AMI or CABG model. We believe that, in tandem,
these proposals would allow for appropriate pricing of AMI model
episodes that continue and include chained anchor hospitalizations.
The proposals to establish pricing for AMI model episodes involving
chained anchor hospitalizations are included in Sec. 512.300(c)(7)(i).
We seek comment on our proposals for pricing AMI episodes involving
chained anchor hospitalizations and the alternative proposals we
considered. We also seek comment on the alternative considered that
would account for both the MS-DRGs at the first and last hospitals
caring for the AMI model beneficiary during the chained anchor
hospitalization in setting the AMI-model episode benchmark price for
episodes involving a chained anchor hospitalization. In particular,
under such an alternative, we seek comment on the clinical
circumstances in which inpatient-to-inpatient transfers are unavoidable
and whether or not there are hospital characteristics that would lead
us to expect higher frequencies of unavoidable inpatient-to-inpatient
transfers for AMI model beneficiaries than hospitals overall. We also
seek comment on how we could discourage unintended consequences under
this alternative, such as less timely decisions about the most
appropriate hospital to treat the beneficiary and increased beneficiary
transfers that are unnecessary or inappropriate for improved quality of
AMI model episode care.
(b) Adjustments for CABG Model Episodes
Among Medicare beneficiaries historically discharged under a CABG
MS-DRG, average episode spending was substantially higher for those
beneficiaries who also had AMI ICD-CM diagnosis codes on their
inpatient claims ($57,000) than those who did not ($44,000).\62\ About
30 percent of CABG beneficiaries had AMI ICD-CM diagnosis codes on
their claims, while about 70 percent did not, and this percentage of
CABG beneficiaries with AMI varied substantially across IPPS hospitals
furnishing CABG procedures.\63\ While average spending, in total, was
substantially higher for CABG beneficiaries with AMI than without AMI,
average spending during the anchor hospitalization was not
substantially higher. Rather, much of this variation in CABG model
episode spending occurred after discharge from the anchor
hospitalization and correlated both with the presence of AMI and
whether the CABG beneficiary was discharged from the anchor
hospitalization in a CABG MS-DRG with major complication or comorbidity
(MS-DRGs 231, 233, or 235) as opposed to a CABG MS-DRG without major
complication or comorbidity (MS-DRGs 232, 234, or 236). Specifically,
we found that average CABG episode spending after discharge from the
anchor hospitalization was--
---------------------------------------------------------------------------
\62\ Episodes for CABG model beneficiaries initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule, that began in CYs 2012-
2014.
\63\ Episodes for CABG model beneficiaries initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule, that began in CYs 2012-
2014.
---------------------------------------------------------------------------
$9,000 for non-AMI CABG beneficiaries discharged from MS-
DRGs 232, 234, or 236;
$11,000 for CABG beneficiaries with AMI discharged from
MS-DRGs 232, 234, or 236;
$16,000 for non-AMI CABG beneficiaries discharged from MS-
DRGs 231, 233, or 235; and
$20,000 for CABG beneficiaries with AMI discharged from
MS-DRGs 231, 233, or 235.\64\
---------------------------------------------------------------------------
\64\ Episodes for CABG model beneficiaries initiated by all U.S.
IPPS hospitals and constructed using standardized Medicare FFS Parts
A and B claims, as proposed in this rule, that began in CYs 2012-
2014.
---------------------------------------------------------------------------
Thus, for CABG model episodes, we propose to set CABG model-episode
benchmark prices by first splitting historical CABG model-episode
expenditures into expenditures that occurred during anchor
hospitalizations and expenditures that occurred after discharge from
the anchor hospitalizations.
We propose to calculate the CABG anchor hospitalization benchmark
price by following the general payment methodology that was applied to
the CJR model, with expenditures limited to those that occurred during
the anchor hospitalization and risk stratification according to the
price CABG MS-DRG (80 FR 73337 through 73358).
We also propose to calculate the CABG post-anchor hospitalization
benchmark price by following the general payment methodology that was
applied to the CJR model, with
[[Page 50852]]
expenditures limited to those that occurred after the anchor
hospitalization and risk-stratification according to the presence of an
AMI ICD-CM diagnosis code on the anchor inpatient claim and whether the
price MS-DRG is a CABG MS-DRG with major complication or comorbidity
(231, 233, or 235) or a CABG MS-DRG without major complication or
comorbidity (232, 234, or 236) (80 FR 73337 through 73358).
We propose that the CABG model-episode benchmark price for an
episode would be the sum of the corresponding CABG anchor
hospitalization benchmark price and the corresponding CABG post-anchor
hospitalization benchmark price, as discussed in this section and in
III.D.4.d.
The proposals to establish pricing for CABG model episodes are
included in Sec. 512.300(c)(7)(ii). We seek comment on our proposals
to establish pricing for CABG model episodes.
(c) Adjustments for Certain AMI Model Episodes With CABG Readmissions
In section III.C.4.b of this proposed rule, we discuss AMI model
episodes where a beneficiary is discharged from an AMI model
participant under an AMI MS-DRG and is later readmitted for a CABG. In
that section, we did not propose to cancel the AMI model episode
altogether for a CABG readmission during the 90-day post-hospital
discharge period or cancel the AMI model episode and initiate a CABG
model episode because planned CABG readmission following an anchor
hospitalization that initiates an AMI episode may be an appropriate
clinical pathway for certain beneficiaries. For example, we noted that
historically approximately 10 percent of those AMI beneficiaries who
received CABGs during AMI episodes would receive the CABGs between 2
and 90 days post-discharge from the anchor hospitalization, and most of
those readmissions did not occur through hospital emergency
departments. Even though CABG readmissions are not excluded from AMI
model episodes (because they are clinically-related to the AMI model
episode), we propose to provide an adjusted AMI model-episode benchmark
price in such circumstances so as not to financially penalize AMI model
participants for relatively uncommon, costly, clinically-appropriate
care patterns for AMI model beneficiaries. Accordingly, we are
proposing to establish an adjusted CABG-readmission AMI model-benchmark
episode price for AMI model episodes with a price MS-DRG of 280-282 or
246-251 that have readmission for a CABG MS-DRG 231-236.
Specifically, if a CABG readmission occurs during an AMI model
episode with a price MS-DRG of 280-282 or 246-251, we propose to
calculate a CABG-readmission AMI model-episode benchmark price equal to
the sum of the standard AMI model-episode benchmark price corresponding
to the price MS-DRG (AMI MS-DRGs 280-282 or PCI MS-DRGs 246-251) and
the CABG anchor hospitalization benchmark price corresponding to the
MS-DRG of the CABG readmission. Because the adjustment would be based
on the anchor hospitalization benchmark price, which does not include
costs associated with the post-discharge period for CABG, this
adjustment approach would avoid ``double counting'' post-discharge
costs. Because adjusting for spending that occurred during a CABG
readmission accounts for most of the spending variation between AMI
model episodes with a CABG readmission and AMI model episodes without a
CABG readmission, we propose no additional adjustment to the price for
AMI model episodes with a CABG readmission.
In the event of any other readmission other than CABG during an AMI
model episode that is not excluded from the AMI model episode
definition, we would apply the usual rules of EPM-episode pricing that
would include the spending for the related readmission in the actual
AMI model-episode spending, without other adjustments. Fewer than 3
percent of those AMI model beneficiaries who receive inpatient or
outpatient PCIs during AMI episodes receive the PCIs between 2 and 90
days post-discharge from the anchor or chained anchor hospitalizations,
and we do not propose to make a pricing adjustment for PCIs that occur
later in the AMI model episodes after discharge from the anchor or
chained anchor hospitalizations. Since a PCI for an AMI typically is
provided during the anchor or chained anchor hospitalization and most
PCIs later in an episode occur in the context of a beneficiary
presenting through the emergency department, we believe that the
beneficiary likely has experienced a complication of care resulting in
a PCI that may potentially be avoided through care management during
the AMI model episode. Given that our intention is to offer appropriate
incentives for care quality and efficiency by holding AMI model
participants accountable for readmissions that could be related to the
quality of care provided prior to the readmission, we believe that an
adjustment other than for a CABG readmission would not be appropriate.
The proposal for adjusting episodes involving CABG readmissions is
included in Sec. 512.300(c)(7)(iii). We seek comment on our proposal
for adjusting episodes involving CABG readmissions.
(d) Potential Future Approaches to Setting Target Prices for AMI and
Hip Fracture Episodes
As previously described, our proposed approach for pricing AMI and
CABG model episodes for beneficiaries with AMI sets different episode
target prices depending upon whether the beneficiary is managed
medically, undergoes PCI, or undergoes CABG during the acute phase of
the episode, as well as whether the episode involves a chained anchor
hospitalization or CABG readmission. Similarly, the target price set
for beneficiaries experiencing hip fracture would depend on whether the
patient undergoes hip fixation (and therefore initiates a SHFFT model
episode) or hip arthroplasty (and therefore initiates a CJR model
episode). We believe that this is a prudent approach that both
recognizes the resource costs of services provided while encouraging
care redesign during the portions of these episodes that we believe
present the greatest opportunities to improve the quality and
efficiency of the care delivered.
However, we note that the general principle guiding our payment
reform efforts is that the payment system should hold providers
accountable for the overall quality and cost of the care their
beneficiaries receive rather than setting their payment based on the
specific services delivered or settings in which they are delivered. We
believe that this approach gives providers maximum flexibility to
redesign care in ways that both produce the best outcomes for patients
and controls the growth in spending for these services.
For this reason, we are interested in exploring future approaches
to episode payment that would set an inclusive target price for
episodes for beneficiaries with AMI that does not depend on whether the
beneficiary is managed medically or receives PCI or CABG during the
acute portion of the episode and, similarly, future approaches that
would set prices for episodes for beneficiaries with hip fracture that
do not depend on whether the beneficiary undergoes hip fixation or hip
arthroplasty. While we believe that the choice of treatment during the
acute phase of these episodes may be determined predominantly by
clinical factors such that financial factors may play a smaller role in
shaping episode
[[Page 50853]]
care redesign than they do following hospital discharge, we
nevertheless believe it would be valuable to consider testing an
inclusive episode payment model. Providers may be able to redesign and
implement care pathways that we might not have otherwise anticipated,
especially as the evidence-base for AMI and hip fracture treatment
continues to grow and evolve.
We seek comment on this type of approach to setting an inclusive
episode target price and on any episode payment model design features
that would be needed to make such an approach successful. In
particular, we seek comment on potential approaches to risk-adjustment
aimed at ensuring that providers are appropriately paid for caring for
high-complexity episode beneficiaries in the context of this
alternative approach. We would seek to ensure that all providers caring
for these episode beneficiaries, including those providers for which we
propose additional protections and those that serve a high percentage
of potentially vulnerable populations of medically and socially complex
patients as discussed in section III.D.7.c. of this proposed rule,
would not bear undue financial risk and to mitigate any incentives to
avoid caring for high-complexity patients. In addition, we seek comment
on whether and how our methodology linking quality performance to
payment under the proposed EPMs and the CJR model might need to be
modified in the context of this alternative approach that would set an
inclusive episode target price, in order to appropriately incentivize
the delivery of high-quality care and discourage stinting on
appropriate care.
(e) Summary of Pricing Methodologies for AMI, CABG, and SHFFT Model
Episode Scenarios
Tables 8 through 10 summarize the standard pricing methodologies
and the adjustments that would occur that are proposed in sections
III.D.4.b.(1) and (2) of this proposed rule for AMI, CABG, and SHFFT
model episodes.
Table 8--AMI Model Pricing Scenarios
------------------------------------------------------------------------
AMI pricing scenario Price
------------------------------------------------------------------------
AMI Scenarios without Chained Anchor Hospitalization
------------------------------------------------------------------------
Single hospital AMI MS[dash]DRG or PCI Episode benchmark price is
MS[dash]DRG (with AMI diagnosis). standard episode benchmark
price based on anchor
MS[dash]DRG (which is the
price MS[dash]DRG).
------------------------------------------------------------------------
AMI Scenarios with Chained Anchor Hospitalizations
------------------------------------------------------------------------
A chained anchor hospitalization where Episode benchmark price is the
the discharge from the first hospital standard episode benchmark
is an AMI MS[dash]DRG or PCI price or the CABG model
MS[dash]DRG (with AMI diagnosis) that episode benchmark price
results in a final discharge from an corresponding to price
AMI, PCI, or CABG MS[dash]DRG MS[dash]DRG, assigned as the
(transfer PCI and CABG MS[dash]DRGs AMI, PCI, or CABG MS[dash]DRG
not required to have AMI ICD[dash]CM with highest IPPS weight.
diagnosis code).
If the price MS[dash]DRG is a
CABG MS[dash]DRG, the CABG
model episode benchmark price
is the sum of the CABG anchor
hospitalization price for the
MS[dash]DRG and the CABG
post[dash]anchor
hospitalization price based on
with AMI ICD[dash]CM diagnosis
code and whether the CABG
MS[dash]DRG is w/MCC or not.
------------------------------------------------------------------------
AMI Scenarios with Readmissions
------------------------------------------------------------------------
An AMI MS[dash]DRG or PCI MS[dash]DRG Episode benchmark price is the
(with AMI diagnosis) anchored episode sum of the standard episode
without a chained anchor benchmark price corresponding
hospitalization ongoing with CABG to the price MS[dash]DRG and
readmission. the CABG anchor
hospitalization benchmark
price corresponding to the
CABG readmission MS[dash]DRG.
AMI MS[dash]DRG or PCI MS[dash]DRG Episode benchmark price is the
(with AMI diagnosis) anchored AMI sum of the standard episode
episode with chained anchor benchmark price for the price
hospitalization (not containing a CABG MS[dash]DRG assigned to the
MS[dash]DRG) ongoing with CABG chained anchor hospitalization
readmission. and the CABG anchor
hospitalization benchmark
price corresponding to the
CABG readmission MS[dash]DRG.
------------------------------------------------------------------------
Table 9--CABG Model Pricing Scenarios
------------------------------------------------------------------------
CABG pricing scenario Price
------------------------------------------------------------------------
Single hospital CABG MS[dash]DRG with Episode benchmark price is the
AMI diagnosis. sum of the CABG anchor
hospitalization benchmark
price for the MS[dash]DRG and
the CABG post[dash]anchor
hospitalization benchmark
price based on the presence of
an AMI ICD[dash]CM diagnosis
code and whether the anchor
MS[dash]DRG is w/MCC or w/o
MCC.
Single hospital CABG MS[dash]DRG Episode benchmark price is the
without AMI diagnosis. sum of the CABG anchor
hospitalization benchmark
price for the MS[dash]DRG and
the CABG post[dash]anchor
hospitalization benchmark
price based on no AMI
ICD[dash]CM diagnosis code and
whether the anchor MS[dash]DRG
is w/MCC or w/o MCC.
------------------------------------------------------------------------
[[Page 50854]]
Table 10--SHFFT Model Pricing Scenarios
------------------------------------------------------------------------
SHFFT Pricing scenario Price
------------------------------------------------------------------------
SHFFT MS[dash]DRG...................... Episode benchmark price is
standard episode benchmark
price based on anchor
MS[dash]DRG (which is the
price MS[dash]DRG).
------------------------------------------------------------------------
(3) Three Years of Historical Data
As was the case for the CJR model, we propose to use 3 years of
historical EPM episodes for calculating EPM participants' EPM-episode
benchmark prices, with each set of historical episodes updated every
other year (80 FR 73340 through 73341). Under our proposal, each of the
first 2 years of historical data would be trended to the most recent of
the 3 years, based on national trend factors for each combination of
price MS-DRGs and payments would be updated for each payment system
(for example, IPPS, PFS, etc.) based on annual changes in input costs
(see sections III.D.4.b(4) and III.D.4.b(5) of this proposed rule that
immediately follow). Under our proposal, we would establish historical
EPM-episode payments based on episodes that started between--
January 1, 2013 and December 31, 2015 for performance
years 1 and 2;
January 1, 2015 and December 31, 2017 for performance
years 3 and 4; and
January 1, 2017 and December 31, 2019 for performance year
5.
We believe that 3 years of historical EPM-episode data should
provide sufficient historical episode volume to reliably calculate EPM-
episode benchmark prices, and that updating these data every other year
would allow us to make the most current claims data available in a way
that incorporates the effects of regular Medicare payment system
updates and changes in utilization without creating uncertainty in
pricing for EPM participants. We would further note that the effects of
updating EPM-participant hospital-specific data on an EPM-episode's
benchmark prices would diminish over time as the contribution of
regional pricing on EPM benchmark prices will increase from one-third
for performance years 1 and 2 to two-thirds in performance year 3, and
100 percent in performance years 4 and 5.
The proposal for 3 years of historical data updated every other
year under the proposed EPMs is included in Sec. 512.300(c)(1).
We seek comment on our proposal for 3 years of historical data
updated every other year.
(4) Trending Historical Data to the Most Recent Year
We recognize that some payment variation could exist in the 3 years
of historical EPM-episode data due to annual Medicare payment system
updates (for example, IPPS, OPPS, IRF PPS, SNF PPS) and national
changes in utilization patterns. Thus, EPM episodes in the third year
of the 3 historical years might have higher average payments than those
from the earlier 2 years, in part due to Medicare payment rate
increases over the course of the 3-year period. Also, EPM-episode
payments could change over time due to national trends reflecting
changes in industry-wide practice patterns. For example, readmissions
for all patients, including those in CABG model episodes, may decrease
nationally due to improved industry-wide surgical protocols that reduce
the chance of infections. We do not intend for the incentives under the
EPMs to be affected by Medicare payment system rate changes that are
beyond EPM participants' control or to provide reconciliation payments
to (or require repayments from) EPM participants for achieving lower
(or higher) Medicare expenditures solely because they followed national
changes in practice patterns. Instead, we aim to incentivize EPM
participants to improve care quality and efficiency based on their
hospital-specific inpatient and post-discharge care practices under the
EPMs.
To mitigate the effects of Medicare payment system updates and
changes in national utilization practice patterns on the 3 years of
historical episode data, we propose to apply a national trend factor to
each of the years of historical EPM-episode payments as we do with the
CJR model (80 FR 73341 through 73342). Specifically, we propose to
inflate the 2 oldest years of historical EPM-episode payments for EPM
episodes to the most recent year of the 3 historical years using
changes in the national EPM-episode payments for each different type of
EPM episode. That is, we propose to apply separate national trend
factors for the following pricing scenarios:
SHFFT model episodes, separately by each price MS-DRG in
480-482.
AMI model episodes without CABG readmissions, separately
by each price MS-DRG in 280-282 and 246-251; and
The anchor hospitalization portion of CABG model episodes,
separately by each price MS-DRG in 231-236.
The post-anchor hospitalization portion of CABG model
episodes, separately for:
++ With AMI ICD-CM diagnosis code on the anchor inpatient claim and
CABG price MS-DRG with major complication or comorbidity (231, 233, or
235);
++ With AMI ICD-CM diagnosis code on the anchor inpatient claim and
CABG price MS-DRG without major complication or comorbidity (232, 234,
or 236);
++ Without AMI ICD-CM diagnosis code on the anchor inpatient claim
and CABG price MS-DRG with major complication or comorbidity (231, 233,
or 235); and
++ Without AMI ICD-CM diagnosis code on the anchor inpatient claim
and CABG price MS-DRG without major complication or comorbidity (232,
234, or 236).
For example, when using Calendar Year (CY) 2013 through 2015
historical EPM-episode data to establish EPM-episode benchmark prices
for performance years 1 and 2, we would calculate an aggregate national
average SHFFT model episode payment in historical episodes with price
MS-DRG 480 for each of the 3 historical years. To trend historical
payments to the most recent year in an historical window, we would
create a ratio based on national average historical EPM-episode payment
for that episode type in a previous year and for the most recent year.
Thus, in this example, we would create a ratio of national average
SHFFT model historical episode payment with price MS-DRG 480 in CY 2015
as compared to that national average SHFFT model historical episode
payment in CY 2013 in order to trend the CY 2013 historical SHFFT model
episode payments to CY 2015. Similarly, we would determine the ratio of
the national average SHFFT model historical episode payment for CY 2015
to national average SHFFT model historical episode payment in CY 2014
to trend 2014 SHFFT model episode payments to CY 2015. This process
would be repeated for each pricing scenario previously listed.
[[Page 50855]]
We believe this method for trending data would capture updates in
Medicare payment systems as well as national utilization pattern
changes that might have occurred within that 3-year period. Moreover,
as with the CJR model, we believe that adjusting for national rather
than regional trends in utilization would be most appropriate as any
Medicare payment system updates and significant changes in utilization
practice patterns would not be region-specific but rather be reflected
nationally.
The proposal for trending historical data is included in Sec.
512.300(c)(11). We seek comment on our proposal for trending historical
data.
(5) Update Historical EPM-Episode Payments To Account for Ongoing
Payment System Updates
As previously mentioned, we propose to prospectively update the
historical EPM-episode payments to account for ongoing updates to
Medicare payment systems (for example, IPPS, OPPS, IRF PPS, SNF, PFS,
etc.) in order to ensure we incentivize EPM participants based on
historical utilization and practice patterns, not Medicare payment
system rate changes that are beyond hospitals' control. Under our
proposal, we would apply the same methodology developed for the CJR
model to incorporate Medicare payment updates (80 FR 73342 through
73446).
Because Medicare payment systems rates are not updated at the same
time during the year--for example, rates under the IPPS, IRF PPS, and
SNF payment systems are updated effective October 1, while the hospital
OPPS and MPFS rates are updated annually effective January 1--we
propose to generally update historical EPM-episode payments and
calculate EPM-episode benchmark prices separately for EPM episodes
initiated between January 1 and September 30 versus October 1 and
December 31 of each performance year, and at other intervals if
determined necessary. The EPM-episode benchmark price in effect as of
the day the EPM episode is initiated would be the EPM-episode benchmark
price for the whole EPM episode. Note that for performance year 5, the
second set of EPM-episode benchmark prices would be for EPM episodes
that start and end between and including October 1 and December 31
because the fifth performance period of the SHFFT, CABG, and AMI models
would end on December 31, 2021. Also, an EPM episode benchmark price
for a given EPM performance year could be applied to EPM episodes
included in another performance year. For example, an EPM episode
initiated in November 2017, and ending in February 2018 would have an
EPM-episode benchmark price based on the second set of 2017 EPM-episode
benchmark prices (for EPM episodes initiated between October 1, 2017,
and December 31, 2017), and it would be captured in the CY 2018 EPM
performance year (performance year 2) because it ended between January
1, 2018, and December 31, 2018. We refer to section III.D.2.a. of this
proposed rule for further discussion on the definition of EPM
performance years.
We propose to update historical EPM-episode payments by applying
separate Medicare payment system update factors each January 1 and
October 1 to each of the following six components of each EPM
participant's historical EPM-episode payments:
Inpatient acute.
Physician.
IRF.
SNF.
HHA.
Other services.
A different set of update factors would be calculated for January 1
through September 30 versus October 1 through December 31 EPM episodes
each EPM performance year. The six update factors for each of the
previously stated components would be EPM-participant hospital-specific
and would be weighted by the percent of the Medicare payment for which
each of the six components accounts in the EPM participant's historical
EPM episodes. The weighted update factors would be applied to
historical EPM-participant hospital-specific average payments to
incorporate ongoing Medicare payment system updates. A weighted update
factor would be calculated by multiplying the component-specific update
factor by the percent of the EPM participant's historical EPM-episode
payments the component represents, and summing together the results.
Each of an EPM participant's six update factors would be based on how
inputs have changed in the various Medicare payment systems for the
specific EPM participant.
As an example, we will assume for purposes of this example that 50
percent of an EPM participant's historical EPM-episode payments were
for inpatient acute care services, 15 percent were for physician
services, 35 percent were for SNF services, and 0.0 percent were for
the remaining services. We will also assume for purposes of this
example that the update factors for inpatient acute care services,
physician services, and SNF services are 1.02, 1.03, and 1.01,
respectively. The weighted update factor in this example would be the
following: (0.5 * 1.02) + (0.15 * 1.03) + (0.35 * 1.01) = 1.018. The
EPM participant in this example would have its historical average EPM-
episode payments multiplied by 1.018 to incorporate ongoing payment
system updates. The specific order of steps, and how this step fits in
with others, is discussed further in sections III.D.4.c through d. of
this proposed rule. Also, as discussed further in sections III.D.4.c.
through d. the update factors would vary by price MS-DRG. For example,
in CABG model episodes, the update factors would be calculated
separately for the anchor hospitalization portion of episodes and the
post-anchor hospitalization portion of episodes, as described in
section III.D.4.d.
Region-specific update factors for each of the previously stated
components and weighted update factors would also be calculated in the
same manner as the EPM-participant hospital-specific update factors.
Instead of using historical EPM episodes attributed to a specific
hospital, region-specific update factors would be based on all
historical EPM episodes initiated at any IPPS hospital within the
region with historical EPM episodes, regardless of whether or not the
MSAs in which the hospitals are located were selected for inclusion in
the models. We refer to the CJR Final Rule for further discussion of
our specific methodology and considerations for adopting this
methodology for updating historical EPM-episode payments for ongoing
payment system updates (80 FR 73342 through 73446).
The proposal for updating episode payments for ongoing annual
Medicare payment updates is included in Sec. 512.300(c)(10). We seek
comment on our proposal for updating episodes payments for ongoing
annual Medicare payment updates.
(6) Blend Hospital-Specific and Regional Historical Data
We propose to calculate EPM-episode benchmark prices using a blend
of EPM-participant hospital-specific and regional historical average
EPM-episode payments, including historical EPM-episode payments for all
IPPS hospitals that are in the same U.S. Census division, which is
discussed further in section III.D.4.b.(7) of this proposed rule.
Specifically, we propose to blend two-thirds of the EPM-participant
hospital-specific historical EPM-episode payments and one-third of the
regional historical EPM-episode payments to set an EPM participant's
EPM-episode benchmark prices for the first 2 performance years of the
proposed EPMs (CYs 2017 and 2018). For performance year 3 of the EPMs
(CY
[[Page 50856]]
2019), we propose to adjust the proportion of the EPM-participant
hospital-specific and regional historical EPM-episode payments used to
calculate the EPM-episode benchmark prices from two-thirds EPM-
participant hospital-specific and one-third regional to one- third EPM-
participant hospital-specific and two-thirds regional. Finally, we
propose to use only regional historical EPM-episode payments for
performance years 4 and 5 of the EPMs (CYs 2020 and 2021) to set an EPM
participant's EPM episode-benchmark prices, rather than a blend between
the hospital-specific and regional historical EPM episode payments.
Consistent with our methodology for the CJR model, we propose two
exceptions. First, we propose to use only regional historical EPM-
episode payments to calculate EPM episode- benchmark prices for EPM
participants with low historic EPM-episode volume (80 FR 73544). For
SHFFT model episodes, this exception applies to SHFFT model
participants with fewer than 50 historical SHFFT model episodes in
total across the 3 historical years. For AMI model episodes anchored by
MS-DRGs 280-282, this exception applies to AMI model participants with
fewer than 75 of these particular AMI model historical episodes in
total across the 3 historical years. For AMI model episodes anchored by
PCI MS-DRGs 246-251, this exception applies to AMI model participants
with fewer than 125 of this particular AMI model historical episodes in
total across the 3 historical years. For CABG model episodes, this
exception applies to CABG model participants with fewer than 50
historical CABG model episodes in total across the 3 historical years.
The proposed thresholds for low historic volume in this proposed rule
are higher than the CJR model threshold for low historical LEJR episode
volume of 20 episodes in total across the 3 historical years. The
higher thresholds are based on the volume thresholds from the BPCI
Model 2 Risk Track B for 90-day episodes, which increase when the ratio
of within-hospital episode spending variation to between-hospital
episode spending variation increases. That is, as EPM episode payment
variation increases within a hospital relative to EPM-episode payment
variation between hospitals, it is necessary to have more EPM episodes
at that hospital to estimate a stable EPM- episode benchmark price
using data from only that hospital. We propose to set higher thresholds
for the SHFFT, AMI, and CABG models based on internal analysis from
BPCI episode data that shows higher within-hospital episode spending
variation relative to between-hospital episode spending variation for
episodes anchored by the EPM MS-DRGs, compared to episodes anchored by
MS-DRGs 469 and 470 included in the CJR model.\65\
---------------------------------------------------------------------------
\65\ BPCI Model 2 Baseline Price Common Template calculations
for 90-day episodes in Risk Track B calculates BPCI volume
thresholds based on the ratio of within-hospital episode spending
variation and between-hospital episode spending variation for BPCI
Clinical Episodes, based on episodes that met BPCI eligibility
criteria and that began in July 1, 2009-June 30, 2012.
---------------------------------------------------------------------------
Second, in the case of an EPM participant that has undergone a
merger, consolidation, spin-off, or other reorganization that results
in a new hospital entity without 3 full years of historical claims
data, we propose that EPM participant hospital-specific historical EPM-
episode payments would be determined using the historical EPM episode
payments attributed to their predecessor(s), as in the CJR model (80 FR
73544).
The aforementioned proposals align with our method for blending EPM
participant hospital-specific and regional data under the CJR model. We
refer to the CJR model Final Rule for further discussion on
alternatives to and reasons for adopting this methodology for the CJR
model, which informs our proposal with respect to the proposed EPMs (80
FR 73346-73349).
The proposal for blending payments when establishing participants'
benchmark and quality-adjusted targets and certain exceptions is
included in Sec. 512.300(c)(2), (3), and (4). We note that the
specific order of steps, and how this step fits in with others, is
discussed further in section III.D.4.c. of this proposed rule. We seek
comment on our proposal for blending payments when establishing
participants' benchmark and quality-adjusted targets as well as the
proposed exceptions.
(7) Define Regions as U.S. Census Divisions
As we do for the CJR model, for all 5 performance years, we
proposed to define ``region'' as one of the nine U.S. Census divisions
\66\ in Figure 1 (80 FR 73349 through 73350).
---------------------------------------------------------------------------
\66\ There are four census regions--Northeast, Midwest, South,
and West. Each of the four census regions is divided into two or
more ``census divisions''. Source: https://www.census.gov/geo/reference/gtc/gtc_census_divreg.html. Accessed on April 15, 2015.
---------------------------------------------------------------------------
[[Page 50857]]
[GRAPHIC] [TIFF OMITTED] TP02AU16.011
We believe U.S. Census divisions provide the most appropriate
balance between very large areas with highly disparate utilization
patterns and very small areas that would be subject to price
distortions due to low volume or hospital-specific utilization
patterns. We clarify that we would ascribe the same regional component
of EPM-episode benchmark prices for EPM participants in MSAs that span
U.S. Census divisions. That is, selected MSAs that span U.S. Census
divisions would be attributed to one U.S. Census division for purposes
of calculating the regional component of an EPM-episode benchmark
price. Specifically, we will attribute an MSA to the U.S. Census
division in which the majority of people in the MSA reside.
---------------------------------------------------------------------------
\67\ http://www.eia.gov/consumption/commercial/census_maps.cfm.
---------------------------------------------------------------------------
The proposal to define a region as one of the nine U.S. Census
divisions is included in Sec. 512.300(c)(2). We seek comment on our
proposal to define region in this manner.
(8) Normalize for Provider-Specific Wage Adjustment Variations
Some variation in historical EPM-episode payments across hospitals
in a region may be due to wage adjustment differences in Medicare
payments. In setting Medicare payment rates, Medicare typically adjusts
facilities' costs attributable to wages and wage-related costs (as
estimated by the Secretary from time to time) by a factor (established
by the Secretary) that reflects the relative wage level in the
geographic are of the facility or practitioner (or the beneficiary's
residence, in the case of home health and hospice services) compared to
a national average wage level. Such adjustments are essential for
setting accurate payments, as wage levels vary significantly across
geographic areas of the country. However, having the wage level for one
hospital influence the regional-component of another hospital's EPM
episode-benchmark price with a different level would introduce
unintended pricing distortion not based on utilization pattern
differences.
To preserve how wage levels affect provider payment amounts, while
minimizing the distortions introduced when calculating the regional-
component of blended EPM-episode benchmark prices, we propose to
normalize for wage indices at the claim level for both historical EPM-
episode payments and actual EPM-episode payments. As discussed in
section III.D.3.b. of proposed rule, we propose to utilize the CMS
Price (Payment) Standardization Detailed Methodology to calculate EPM-
episode benchmark and quality-adjusted target prices and actual EPM-
episode spending. This methodology removes wage level differences in
calculating standardized payment amounts.
We believe it is important to reintroduce wage index variations
near the end of the EPM-episode price-setting methodology and when
calculating actual EPM-episode payments during an EPM performance year,
to account for the differences in cost for care redesign across
different geographic areas of the country. For example, hiring
additional hospital staff to aid in patient follow-up during the post-
discharge period of an AMI model episode would be significantly more
costly in San Francisco than in rural Idaho. If we do not reintroduce
wage index variations into EPM-episode benchmark price and actual EPM-
episode payment calculations, we would calculate reconciliation and
repayment amounts that would not capture labor cost variation
throughout the country, and EPM participants in certain regions may see
less opportunity and financial incentive to invest in care redesign.
Thus, when setting EPM-episode benchmark prices and calculating actual
EPM-episode payments, we propose to reintroduce the hospital-specific
wage variations by multiplying EPM-episode payments by the wage
normalization factor when calculating the EPM-episode benchmark prices
and actual EPM -episode payments for each EPM participant, as described
in section III.D.4.c. of the proposed rule.
We propose to use the following algorithm to create a wage
normalization factor: 0.7 * IPPS wage index + 0.3. The 0.7 approximates
the
[[Page 50858]]
labor share in IPPS, IRF PPS, SNF, and HHA Medicare payments. The
specific order of steps, and how this step fits in with others, is
discussed further in section III.D.4.c. of the proposed rule. We refer
to the CJR model Final Rule for more detailed information on our
normalization process adopted for the CJR model (80 FR 73350 through
73352).
The proposal to normalize for provider-specific wage adjustment
variations is included in Sec. 512.300(c)(12). We seek comment on our
proposal to normalize for these variations.
(9) Combining Episodes To Set Stable Benchmark and Quality-Adjusted
Target Prices
For the purposes of having sufficient episode volume to set stable
EPM-episode benchmark and quality-adjusted target prices, we propose
generally to follow the process from the CJR model to calculate
severity factors, EPM-participant hospital-specific weights, and
region-specific weights that allow us to surmount issues of low volume
for EPM episodes with particular characteristics by aggregating EPM
episodes and portions of EPM episodes across dimensions that include
anchor MS-DRGs, the presence of AMI ICD-CM diagnosis code on the anchor
inpatient claim, and the presence of a major complication or
comorbidity for anchor CABG MS-DRGs (80 FR 73352 through 73353). Where
the CJR Final Rule refers to anchor factors, for the purposes of this
proposed rule we refer to severity factors to avoid confusion when
performing calculations pertaining to expenditures that occurred during
the anchor hospitalization and after the anchor hospitalization in CABG
model episodes.
For SHFFT model episodes, we propose to combine episodes with price
MS-DRGs 480-482 to use a greater historical episode volume to set more
stable SHFFT episode benchmark and quality-adjusted target prices. To
do so, we propose to calculate severity factors for episodes with price
MS-DRGs 480 and 481 equal to--
[GRAPHIC] [TIFF OMITTED] TP02AU16.012
The national average would be based on SHFFT model episodes attributed
to any IPPS hospital. The resulting severity factors would be the same
for all SHFFT model participants. For each SHFFT model participant, a
hospital weight would be calculated using the following formula, where
SHFFT model episode counts are SHFFT-model-participant hospital-
specific and based on the SHFFT model episodes in the 3 historical
years used in SHFFT model episode benchmark and quality-adjusted target
price calculations:
[GRAPHIC] [TIFF OMITTED] TP02AU16.013
A SHFFT model participant's hospital-specific average episode
payment would be calculated by multiplying such participant's hospital
weight by its combined historical average episode payment (sum of
historical episode payments for historical episodes with price MS-DRGs
480-482 divided by the number of historical episodes with price MS-DRGs
480-482). The calculation of the hospital weights and the hospital-
specific pooled historical average episode payments would be comparable
to how case-mix indices are used to generate case-mix adjusted Medicare
payments. The hospital weight essentially would count each episode with
price MS-DRGs 480 and 481 as more than one episode (assuming episodes
with price MS- DRGs 480 and 481 have higher average payments than
episodes with price MS-DRG 482) so that the pooled historical average
episode payment, and subsequently the SHFFT model episode benchmark and
quality-adjusted target prices, are not skewed by the SHFFT model
participant's relative breakdown of historical episodes with price MS-
DRGs 480 and 481 versus historical episodes with price MS-DRG 482.
We would calculate region-specific weights and region-specific
pooled historical average payments following the same steps proposed
for hospital-specific weights and hospital-specific pooled average
payments. Instead of grouping episodes by the attributed hospital as is
proposed for hospital-specific calculations, region-specific
calculations would group together SHFFT model episodes that were
attributed to any IPPS hospital located within the region. The
hospital-specific and region-specific pooled historical average
payments would be blended together as discussed in section
III.D.4.b.(6) of the proposed rule. The specific order of steps, and
how this step fits in with others, is discussed further in section
III.D.4.c. of the proposed rule.
Afterwards, the blended pooled calculations would be ''unpooled''
by setting the episode benchmark price for episodes with price MS-DRG
482 to the resulting calculation, and by multiplying the resulting
calculation by the severity factors to produce the episode benchmark
prices for episodes with price MS-DRGs 480 and 481. Applying the
discount factor as discussed in III.D.4.b.(10) and III.D.4.c. would
result in the SHFFT model quality-adjusted target prices for episodes
with price MS-DRGs 480-482.
For episodes in the AMI model with price MS-DRGs in 280-282 or 246-
251
[[Page 50859]]
and without readmissions for CABG MS-DRGs, we propose to follow an
analogous procedure to the SHFFT model with the following
modifications. First we propose to group episodes with price MS-DRGs
280-282 separately from episodes with price MS-DRGs 246-251 for the
calculations. Second, we propose to calculate severity factors for
episodes with price MS-DRGs 280-282 as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.014
Third, we propose to calculate hospital-specific weights and
region-specific weights for episodes with price MS-DRGs 280-282 as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.015
Fourth, we propose to calculate severity factors for episodes with
price MS-DRG 246-251 as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.016
Fifth, we propose to calculate hospital-specific weights and region-
specific weights for episodes with price MS-DRG 246-251 as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.017
[[Page 50860]]
After blending historical and regional pooled episode payments for
episodes with price MS-DRGs 280-282, the blended pooled calculations
would be ''unpooled'' by setting the episode benchmark price for price
MS-DRG 282 to the resulting calculation, and by multiplying the
resulting calculation by the severity factors to produce the episode
benchmark prices for price MS-DRGs 280 and 281.
After blending historical and regional pooled episode payments for
episodes with price MS-DRGs 246-251, the blended pooled calculations
would be ''unpooled'' by setting the episode benchmark price for price
MS-DRG to the resulting calculation, and by multiplying the resulting
calculation by the severity factors to produce the episode benchmark
prices for price MS-DRGs 246-251.
Applying the discount factor as discussed in III.D.4.b.(10) and
III.D.4.c would result in the quality-adjusted target prices for price
MS-DRGs 280-282 and 246-251.
For episodes in the CABG model with price MS-DRGs in 231-236, we
propose to calculate severity factors, hospital-specific weights, and
region-specific weights separately for the anchor hospitalization
portion of CABG model episodes and the post-anchor hospitalization
portion of CABG model episodes.
For the anchor hospitalization portion of CABG model episodes, we
propose to follow an analogous procedure to the SHFFT model with the
anchor hospitalization portion of CABG model episodes grouped by the
price MS-DRG. Specifically, we propose to calculate anchor
hospitalization severity factors for price MS-DRGs 231-235 as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.018
We also propose to calculate hospital-specific weights and region-
specific weights for the anchor hospitalization portion of CABG model
episodes as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.019
After blending historical and regional pooled anchor
hospitalization payments for the CABG model episodes, the blended
pooled calculations would be ''unpooled'' by setting the price MS-DRG
236 anchor hospitalization benchmark price to the resulting
calculation, and by multiplying the resulting calculation by the
severity factors to produce the anchor hospitalization benchmark prices
for price MS-DRGs 231-235.
For the post-anchor hospitalization portion of CABG model episodes,
we propose to follow an analogous procedure to the SHFFT model with the
post-anchor hospitalization portion of
[[Page 50861]]
CABG model episodes grouped in the following manner--
With AMI diagnosis on the anchor inpatient claim and price
MS-DRG with major complication or comorbidity (231, 233, or 235)
With AMI diagnosis on the anchor inpatient claim and price
MS-DRG without major complication or comorbidity (232, 234, or 236)
Without AMI diagnosis on the anchor inpatient claim and
price MS-DRG with major complication or comorbidity (231, 233, or 235)
Without AMI diagnosis on the anchor inpatient claim and
price MS-DRG without major complication or comorbidity (232, 234, or
236)
Specifically, we propose to calculate post-anchor hospitalization
severity factors as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.020
[GRAPHIC] [TIFF OMITTED] TP02AU16.021
We also propose to calculate hospital-specific weights and region-
specific weights for the post-anchor hospitalization portion of CABG
model episodes as--
[GRAPHIC] [TIFF OMITTED] TP02AU16.022
After blending historical and regional pooled post-anchor
hospitalization payments for the CABG model episodes, the blended
pooled calculations would be ''unpooled'' by setting the without AMI
ICD-CM diagnosis code on the anchor inpatient claim and price MS-DRG
without major complication or comorbidity (232, 234, or 236) post-
anchor hospitalization benchmark price to the resulting calculation,
and by multiplying the resulting calculation by the severity factors to
produce the post-anchor hospitalization benchmark prices for:
With AMI diagnosis on the anchor inpatient claim and price
MS-DRG with major complication or comorbidity (231, 233, or 235)
With AMI diagnosis on the anchor inpatient claim and price
MS-DRG without major complication or comorbidity (232, 234, or 236)
Without AMI diagnosis on the anchor inpatient claim and
price MS-DRG with major complication or comorbidity (231, 233, or 235)
We propose to calculate episode benchmark prices for CABG model
episodes by summing combinations of CABG anchor hospitalization
benchmark prices and CABG post-anchor hospitalization benchmark prices.
Applying the discount factor as discussed in III.D.4.b.(10) and
III.D.4.d of this proposed rule would result in the quality-adjusted
target prices for CABG model episodes.
For episodes in the AMI model with CABG readmissions, we propose to
perform no additional blending of hospital-specific and regional-
specific episode payments. We propose to calculate the AMI model
episode benchmark and quality-adjusted target prices for such episodes
as described in section III.D.4.e. of this proposed rule.
The proposals to combine episodes to set stable benchmark and
quality-adjusted target prices are included in Sec. 512.300(c)(13). We
seek comment on our proposals for combining episodes for these
purposes.
(10) Effective Discount Factors
As discussed in section III.D.2.c. of this proposed rule, we
propose to make EPM participants partly or fully accountable for EPM-
episode payments in relationship to the EPM quality-adjusted target
price. As part of this, in setting an episode quality-adjusted target
price for an EPM participant, we propose to apply an effective discount
factor to an EPM participant's hospital-
[[Page 50862]]
specific and regional blended historical EPM-episode payments for a
performance period. We expect EPM participants to have a significant
opportunity to improve the quality and efficiency of care furnished
during episodes in comparison with historical practice, because the
EPMs would facilitate the alignment of financial incentives among
providers caring for EPM beneficiaries. Our proposed effective discount
factors are intended to serve as Medicare's portion of reduced
expenditures from an EPM episode with any EPM-episode expenditures
below the quality-adjusted target price potentially available as
reconciliation payments to the EPM participant where the anchor
hospitalization occurred.
For the EPMs, we propose to establish a 3 percent effective
discount factor to calculate the quality-adjusted target prices for EPM
participants in the below acceptable and acceptable quality categories,
as discussed in section III.E.3.f. of this proposed rule and similar to
the CJR model (80 FR 73355). The effective discount factor to calculate
the quality-adjusted target price for EPM participants in the good and
excellent quality categories would be 2 percent and 1.5 percent,
respectively.
Because of the proposed phase-in of repayment responsibility as
discussed in section III.D.2.c. of this proposed rule, with no
responsibility in either performance year 1 or performance year 2 (NDR)
and only partial repayment responsibility in performance year 2 (DR)
and all of performance year 3, an EPM participant with actual EPM-
episode payments that exceed the quality-adjusted target prices
multiplied by the EPM participant's number of EPM episodes to which
each quality-adjusted target price would apply in performance year 2
(DR) and performance year 3 would owe Medicare less that would
otherwise result from this calculation. As discussed in section
III.E.3.f of this rule, an ``applicable discount factor'' applies to
repayment amounts in performance years 2 and 3 while this repayment
responsibility is being phased-in. We refer to section III.E.1. and
specifically Tables 20 through 28 in this proposed rule for further
illustration of the discount percentages that would apply for
reconciliation payment and Medicare repayment over the 5 EPM
performance years. We believe this methodology offers EPM participants
an opportunity to create savings for themselves and Medicare, while
also maintaining or improving quality of care for EPM model
beneficiaries.
The proposal to establish discount factors that would apply to the
quality categories is included in Sec. 512.300(d). We seek comment on
our proposal to establish discount factors that apply to the quality
categories.
c. Approach To Combine Pricing Features for all SHFFT Model Episodes
and AMI Model Episodes Without CABG Readmissions
The following presents our proposed methodology for combining the
pricing features presented in section III.D.4.b. of this proposed rule
with respect to SHFFT model episodes and AMI model episodes without a
CABG readmission.
Step 1--Calculate historical EPM-episode payments for
episodes that were initiated during the 3-historical-years of each
applicable EPM (that is, individually for each of the SHFFT and AMI
models) (section III.D.4.b.(3) of this proposed rule) for all IPPS
hospitals for all Medicare Part A and B services included in the EPM
episodes. Limit the potential AMI model episodes to those episodes with
price MS-DRGs in 280-282 or 246-251 and without readmissions for CABG
MS-DRGs. We note that specific PBPM payments may be excluded from
historical EPM-episode payment calculations as discussed in section
III.D.6.d. of this proposed rule.
Step 2--Remove the effects of special payment provisions
(section III.D.3.b. of this proposed rule) and normalize for wage index
differences (section III.D.4.b.(8) of this proposed rule) by
standardizing Medicare FFS payments at the claim-level.
Step 3--Prorate Medicare payments for included episode
services that span a period of care that extends beyond the episode
(section III.D.3.c. of this proposed rule.).
Step 4--Trend forward the 2 oldest historical years of
data to the most recent year of historical data (section III.D.4.b.(4)
of this proposed rule). Separate national trend factors would be
applied for each combination of price MS-DRGs.
Step 5--Cap high episode payment episodes with a region-
and price-MS-DRG-specific high payment ceiling (section III.D.3.d. of
this proposed rule), using the episode output from the previous step.
Step 6--Group episodes based on price MS-DRGs (SHFFT MS-
DRGs 480-482; AMI MS-DRGs 280-282; PCI MS-DRGs 246-251). Within each
group of episodes, calculate severity factors and EPM-participant
hospital-specific weights (section III.D.4.b.(9) of this proposed rule)
using the episode output from the previous step to pool together
episodes in each group of price MS-DRGs, resulting in EPM-participant
hospital-specific pooled historical average episode payments for each
group of price MS-DRGs. Similarly, calculate region-specific weights to
calculate region-specific pooled historical average episode payments
for each group of price MS-DRGs.
Step 7--Calculate EPM-participant hospital-specific and
region-specific weighted update factors (section III.D.4.b.(5) of this
proposed rule). Multiply each EPM-participant hospital-specific and
region-specific pooled historical average episode payment by its
corresponding EPM-participant hospital-specific and region-specific
weighted update factors to calculate EPM-participant hospital-specific
and region-specific updated, pooled, historical average episode
payments.
Step 8--Blend together each EPM-participant hospital-
specific updated, pooled, historical average episode payment with the
corresponding region-specific updated, pooled, historical average
episode payment according to the proportions for the EPM performance
year (III.D.4.b.(6) of this proposed rule). EPM participants that do
not have the minimum episode volume across the historical 3 years would
use 0.0 percent and 100 percent as the proportions for hospital and
region, respectively.
Step 9--Multiply the outputs of step (8) by the wage
normalization factor described in section III.D.4.b.(8) of this
proposed rule to reintroduce geographic variation. For purposes of this
proposed rule, we will define the three outputs of this step as the
standard episode benchmark price for--
++ SHFFT model episodes with price MS-DRG 482
++ AMI model episodes with price MS-DRG 282 without readmission for
CABG, and
++ AMI model episodes with price MS-DRG 251 without readmission for
CABG.
Step 10--Multiply the output of step (9) by the
appropriate severity factors (step (6) of this calculation process and
detailed in section III.D.4.b.(9) of this proposed rule) to calculate
the standard episode benchmark prices for--
++ SHFFT model episodes with price MS-DRGs 480-481
++ AMI model episodes with price MS-DRGs 280-281 without readmission
for CABG
++ AMI model episodes with price MS-DRGs 246-250 without readmission
for CABG
[[Page 50863]]
Step 11--Multiply the outputs of step (9) and (10) by 1
minus the applicable effective discount factor based on the EPM
participant's quality category as described in sections III.D.4.b.(10)
and III.E.3.f. of this proposed rule. For purposes of this proposed
rule, we will define the outputs of this step as the episode quality-
adjusted target prices for:
++ SHFFT model episodes with price MS-DRGs 480-482
++ AMI model episodes with price MS-DRGs 280-282 without readmission
for CABG, and
++ AMI model episodes with price MS-DRGs 246-251 without readmission
for CABG
d. Approach To Combine Pricing Features for CABG Model Episodes
The following presents our proposed methodology for combining the
pricing features presented in section III.D.4.b of this proposed rule
with respect to CABG model episodes.
(1) Anchor Hospitalization Portion of CABG Model Episodes
Step 1--Calculate historical episode payments that
occurred during the anchor hospitalization of CABG model episodes that
were initiated during the 3 historical years (section III.D.4.b.(2) of
this proposed rule) for all IPPS hospitals for all Medicare Part A and
B services included in the episodes. We note that specific PBPM
payments may be excluded from historical episode payment calculations
as discussed in section III.D.6. of this proposed rule.
Step 2--Apply steps III.D.4.c.(2) through (4) to the
results of step (1) with trend factors calculated based on the anchor
hospitalization portion of CABG model episodes with price MS-DRGs 231-
236.
Step 3--Group the anchor hospitalization portion of
episodes based on price MS-DRGs 231-236 and apply steps III.D.4.c.(6)
through (10) to the anchor hospitalization portion of the CABG model
episodes with severity factors, hospital-specific weighted update
factors, and region-specific weighted update factors calculated to
apply based only on the anchor hospitalization portion of CABG model
episodes with price MS-DRGs 231-236. For purposes of this proposed
rule, we will define the output of this step as CABG anchor
hospitalization benchmark prices for CABG model episodes with price MS-
DRGs 231-236.
(2) Approach To Combine Pricing Features for Post-Anchor
Hospitalization Portion of CABG Model Episodes
Step 1--Calculate historical episode payments that
occurred after the anchor hospitalization for CABG model episodes that
were initiated during the 3 historical years (section III.D.4.b.(2) of
this proposed rule) for all IPPS hospitals for all Medicare Parts A and
B services included in the episodes. We note that specific PBPM
payments may be excluded from historical episode payment calculations
as discussed in section III.D.6. of this proposed rule.
Step 2--Apply steps III.D.4.c.(2) through (4) to the
results of step (1) with trend factors calculated based on the post-
anchor hospitalization portion of CABG model episodes with price MS-
DRGs 231-236, as described in section III.D.4.b.(4) of this proposed
rule.
Step 3--Group the post-anchor hospitalization portion of
episodes based on--
++ With AMI diagnosis on the anchor inpatient claim and price MS-DRG
with major complication or comorbidity (231, 233, or 235)
++ With AMI diagnosis on the anchor inpatient claim and price MS-DRG
without major complication or comorbidity (232, 234, or 236)
++ Without AMI diagnosis on the anchor inpatient claim and price MS-DRG
with major complication or comorbidity (231, 233, or 235)
++ Without AMI diagnosis on the anchor inpatient claim and price MS-DRG
without major complication or comorbidity (232, 234, or 236).
Then apply steps III.D.4.c.(6)-(10) to the post-anchor
hospitalization portion of the CABG model episodes with severity
factors, hospital-specific weights, and region-specific weights
calculated to apply based on the groups previously described in this
step. For purposes of this proposed rule, we will define the output of
this step as CABG post-anchor hospitalization benchmark prices for CABG
model episodes corresponding to the groups described in this step.
(3) Combine CABG Anchor Hospitalization Benchmark Price and CABG Post-
Anchor Hospitalization Benchmark Price
Step 1--Sum the CABG anchor hospitalization benchmark
price corresponding to each price CABG MS-DRG and the CABG post-anchor
hospitalization price corresponding to each of the post-anchor
hospitalization groupings described in III.D.4.d.(2). For purposes of
this proposed rule, we will define the outputs of those calculations to
be CABG model episode benchmark prices for--
++ CABG model episodes with price MS-DRG 231 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 232 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 233 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 234 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 235 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 236 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 231 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 232 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 233 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 234 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 235 and without AMI diagnosis,
and
++ CABG model episodes with price MS-DRG 236 and without AMI diagnosis
The CABG episode benchmark prices for each price CABG MS-DRG with
AMI diagnosis would also apply as AMI model episode benchmark prices
for AMI model episodes with price MS-DRGs 231-236.
Step 2--Multiply the results of step 1 by the appropriate
effective discount factor that reflects the EPM participant's quality
category as described in sections III.D.4.b.(10) and III.E.3.f. of this
proposed rule. For purposes of this proposed rule, we will define the
outputs of this step to be CABG model episode quality-adjusted target
prices for--
++ CABG model episodes with price MS-DRG 231 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 232 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 233 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 234 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 235 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 236 and with AMI diagnosis
++ CABG model episodes with price MS-DRG 231 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 232 and without AMI diagnosis
[[Page 50864]]
++ CABG model episodes with price MS-DRG 233 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 234 and without AMI diagnosis
++ CABG model episodes with price MS-DRG 235 and without AMI diagnosis,
and
++ CABG model episodes with price MS-DRG 236 and without AMI diagnosis
The episode quality-adjusted target prices for each anchor CABG MS-
DRG with AMI diagnosis would also apply as AMI model episode quality-
adjusted target prices for AMI model episodes with price MS-DRGs 231-
236. The effective discount factor applied to calculate the AMI model
episode quality-adjusted target prices for AMI model episodes with
price MS-DRGs 231-236 could differ from the effective discount factor
applied to calculate CABG model episode quality-adjusted target prices
for CABG model episodes if the participant had different levels of
quality performance on the AMI and CABG model composite quality scores
that determine the discount factor for the quality-adjusted target
prices.
e. Approach To Combine Pricing Features for AMI Model Episodes With
CABG Readmissions
The following presents our proposed methodology for combining the
pricing features presented in section III.D.4.b of this proposed rule
with respect to AMI model episodes with a CABG readmission.
In general, the AMI model episode benchmark price for AMI model
episodes with CABG readmission is the sum of the applicable standard
AMI model episode benchmark price for an AMI episode without
readmission corresponding to the AMI price MS-DRG and the applicable
CABG anchor hospitalization benchmark price for a CABG model episode
corresponding to the CABG readmission MS-DRG in the AMI model.
Step 1--For each combination of AMI price MS-DRG and CABG
readmission MS-DRG, sum the corresponding AMI model episode benchmark
price and CABG anchor hospitalization benchmark price. This results in
54 possible CABG readmission AMI model episode benchmark prices,
corresponding to--
++ Price MS-DRG 280; Readmission MS-DRG 231
++ Price MS-DRG 280; Readmission MS-DRG 232
++ Price MS-DRG 280; Readmission MS-DRG 233
++ Price MS-DRG 280; Readmission MS-DRG 234
++ Price MS-DRG 280; Readmission MS-DRG 235
++ Price MS-DRG 280; Readmission MS-DRG 236
++ Price MS-DRG 281; Readmission MS-DRG 231
++ Price MS-DRG 281; Readmission MS-DRG 232
++ Price MS-DRG 281; Readmission MS-DRG 233
++ Price MS-DRG 281; Readmission MS-DRG 234
++ Price MS-DRG 281; Readmission MS-DRG 235
++ Price MS-DRG 281; Readmission MS-DRG 236
++ Price MS-DRG 282; Readmission MS-DRG 231
++ Price MS-DRG 282; Readmission MS-DRG 232
++ Price MS-DRG 282; Readmission MS-DRG 233
++ Price MS-DRG 282; Readmission MS-DRG 234
++ Price MS-DRG 282; Readmission MS-DRG 235
++ Price MS-DRG 282; Readmission MS-DRG 236
++ Price MS-DRG 246; Readmission MS-DRG 231
++ Price MS-DRG 246; Readmission MS-DRG 232
++ Price MS-DRG 246; Readmission MS-DRG 233
++ Price MS-DRG 246; Readmission MS-DRG 234
++ Price MS-DRG 246; Readmission MS-DRG 235
++ Price MS-DRG 246; Readmission MS-DRG 236
++ Price MS-DRG 247; Readmission MS-DRG 231
++ Price MS-DRG 247; Readmission MS-DRG 232
++ Price MS-DRG 247; Readmission MS-DRG 233
++ Price MS-DRG 247; Readmission MS-DRG 234
++ Price MS-DRG 247; Readmission MS-DRG 235
++ Price MS-DRG 247; Readmission MS-DRG 236
++ Price MS-DRG 248; Readmission MS-DRG 231
++ Price MS-DRG 248; Readmission MS-DRG 232
++ Price MS-DRG 248; Readmission MS-DRG 233
++ Price MS-DRG 248; Readmission MS-DRG 234
++ Price MS-DRG 248; Readmission MS-DRG 235
++ Price MS-DRG 248; Readmission MS-DRG 236
++ Price MS-DRG 249; Readmission MS-DRG 231
++ Price MS-DRG 249; Readmission MS-DRG 232
++ Price MS-DRG 249; Readmission MS-DRG 233
++ Price MS-DRG 249; Readmission MS-DRG 234
++ Price MS-DRG 249; Readmission MS-DRG 235
++ Price MS-DRG 249; Readmission MS-DRG 236
++ Price MS-DRG 250; Readmission MS-DRG 231
++ Price MS-DRG 250; Readmission MS-DRG 232
++ Price MS-DRG 250; Readmission MS-DRG 233
++ Price MS-DRG 250; Readmission MS-DRG 234
++ Price MS-DRG 250; Readmission MS-DRG 235
++ Price MS-DRG 250; Readmission MS-DRG 236
++ Price MS-DRG 251; Readmission MS-DRG 231
++ Price MS-DRG 251; Readmission MS-DRG 232
++ Price MS-DRG 251; Readmission MS-DRG 233
++ Price MS-DRG 251; Readmission MS-DRG 234
++ Price MS-DRG 251; Readmission MS-DRG 235, and
++ Price MS-DRG 251; Readmission MS-DRG 236
Step 2--Multiply the results of step 1 by the effective
discount factor that reflects the EPM participant's quality category,
as described in sections III.D.4.b.(10) and III.E.3.f. of this proposed
rule. For purposes of this proposed rule, we will define the outputs of
this step to be AMI model episode quality-adjusted target prices for
the same combinations of AMI price MS-DRG and readmission MS-DRG in
step (1).
5. Process for Reconciliation
a. Net Payment Reconciliation Amount (NPRA)
Consistent with the CJR model, we propose to conduct reconciliation
for each EPM by calculating an EPM-specific NPRA for each EPM
participant (80 FR 73381 through 73383). After the completion of an EPM
performance year, we propose to retrospectively calculate an EPM
participant's actual EPM-episode payments based on the EPM episode
definitions as discussed in sections III.C.3. and III.C.4. of this
proposed rule and the payment policies applicable to calculating actual
EPM-episode payments as discussed in the subsections of section III.D.3
of this proposed rule.
We propose to compare each EPM participant's actual EPM episode
payments to its quality-adjusted target prices. We propose, as
discussed in
[[Page 50865]]
section III.D.4. of this proposed rule, that an EPM participant would
have multiple quality-adjusted target prices for EPM episodes ending in
a given performance year, based on the anchor MS-DRG for the EPM
episode, whether the EPM episode included a chained anchor
hospitalization; whether the EPM episode included readmission for CABG
MS-DRGs; whether the EPM episode included an AMI ICD-CM diagnosis code
on the anchor inpatient claim; the performance year when the EPM
episode was initiated; when the EPM episode was initiated within a
given performance year (January 1 through September 30 of the
performance year, October 1 through December 31 of the performance
year, October 1 through December 31 of the prior performance year); and
the potential effective discount factors. The difference between each
EPM episode's actual EPM episode payment and the relevant quality-
adjusted target price under the EPM (calculated as quality-adjusted
target price subtracted by actual EPM episode payment) would be
aggregated for all EPM episodes in each EPM for an EPM participant
within the performance year, representing the NPRA. For performance
year 2, we would perform two separate aggregations in order to create
two NPRAs--one reflecting episodes that ended during performance year 2
(NDR), and a second for episodes that ended during performance year 2
(DR).
We propose to not include any reconciliation payments or repayments
to Medicare under the EPMs for a given performance year when
calculating actual episode spending and, therefore the NPRA for a
subsequent performance year. We want to incentivize providers to
provide high-quality and efficient care in all years of the EPMs. If
reconciliation payments for a performance year were counted as Medicare
expenditures in a subsequent performance year, an EPM participant would
experience higher Medicare expenditures in the subsequent performance
year as a consequence of providing high-quality and efficient care in
the prior performance year, negating some of the incentive to perform
well in the prior year. Therefore, we propose to not have the NPRA for
a given performance year be impacted by EPM repayments or
reconciliation payments made in a prior performance year. For example,
if an EPM participant receives a $10,000 reconciliation payment in the
second quarter of 2018 for achieving episode spending below the
quality-adjusted target price for performance year 1, that $10,000
reconciliation payment amount would not be included in the performance
year 2 calculations of actual EPM-episode payments.
The NPRA would be subject to the stop-loss and stop-gain limits
described in section III.D.7.b. of this proposed rule.
b. Payment Reconciliation
We propose to retrospectively reconcile an EPM participant's actual
EPM-episode payments against the quality-adjusted target prices 2
months after the end of the performance year. Specifically, we would
capture claims submitted by March 1st following the end of the
performance year and carry out the NPRA calculation as described
previously to make an EPM reconciliation payment or hold hospitals
responsible for repayment, as applicable, in quarter 2 of that calendar
year.
We also propose that during the following performance year's
reconciliation process, we would calculate the prior performance year's
actual EPM episode payments a second time to account for final claims
run-out and any canceled EPM episodes, due to overlap with other models
or other reasons as specified in section III.C.4.b of this proposed
rule. This calculation, termed the subsequent reconciliation, would
occur approximately 14 months after the end of the prior performance
year. As discussed later in this section, the amount from this
calculation, if different from zero, would be applied to the NPRA for
the subsequent performance year, as well as the post-episode spending
and ACO overlap calculation in order to determine the amount of the
payment Medicare would make to the EPM participant or such
participant's repayment amount. We note that the subsequent
reconciliation calculation would be combined with the previous
calculation of NPRA for a performance year to ensure the stop-loss and
stop-gain limits discussed in section III.D.7.b. of this proposed rule
are not exceeded for a given performance year.
For the performance year 1 reconciliation process, we would
calculate an EPM participant's NPRA as previously described, and if
positive, such participant would receive the amount as a reconciliation
payment from Medicare, subject to the stop-gain limit for performance
year 1. If negative, the EPM participant would not be responsible for
repayment to Medicare, consistent with our proposal to phase in
financial responsibility beginning in the second quarter of performance
year 2.
For the performance year 2 reconciliation process, we would
calculate two separate NPRAs for an EPM participant--one for episodes
that ended during performance year 2 (NDR) and a second for episodes
that ended during performance year 2 (DR). While these NPRAs would be
separately determined for each of these two periods, whether an EPM
participant receives a Medicare reconciliation payment or makes a
Medicare repayment in performance year 2 would be determined based on
the sum of these two separately determined NPRAs. The NPRA for both
performance year 2 (NDR) and performance year 2 (DR) would be subject
to the same stop-gain limit of 5 percent, but because EPM participants
would only have repayment responsibility for negative NPRA in
performance year 2 (DR), the stop-loss limit of 5 percent would only
apply to performance year 2 (DR). Thus, if an EPM participant's NPRA
for the first quarter of performance year 2 is positive, that amount
would be counted toward a reconciliation payment from Medicare, subject
to the stop-gain limit for performance year 2. If negative, the EPM
participant would not be responsible for repayment to Medicare of the
amount determined for performance year 2 (NDR). If an EPM participant's
NPRA is positive for episodes ending during performance year 2 (DR),
that amount would be counted toward a reconciliation payment from
Medicare, subject to the stop-gain limit for performance year 2. If
negative, the EPM participant would be responsible for repayment to
Medicare of the amount determined for episodes ending during
performance year 2 (DR), subject to the stop loss limits for
performance year 2 (DR).
During the subsequent reconciliation process for performance year
2, we would also calculate the prior performance year's actual EPM
episode payments a second time separately for episodes that ended
during performance year 2 (NDR) and for episodes that ended during
performance year 2 (DR).
Also, starting with the EPM reconciliation process for performance
year 2, in order to determine the reconciliation or repayment amount,
the amount from the subsequent reconciliation calculation would be
combined with the NPRA for that subsequent year. The result of the
post-episode spending calculation for performance year 1, as proposed
in section III.D.7.e., and the dollar amount of the EPM discount
percentage that was paid out as shared savings to an ACO during the
prior year as specified in section III.D.6.b. of this proposed rule,
would also be added to the NPRA and subsequent reconciliation
calculation in
[[Page 50866]]
order to create the reconciliation payment or repayment amount. If the
amount is positive, and if the EPM participant is in the acceptable or
better quality category for the EPM (discussed further in section
III.E.3.f of this proposed rule), the EPM participant would receive the
amount as a reconciliation payment from Medicare. If the amount is
negative, Medicare would hold the EPM participant responsible for
repaying the absolute value of the repayment amount following the rules
and processes for all other Medicare debts. For example, when we
conduct reconciliation for performance year 2 in early 2019, we would
calculate the performance year 2 NPRA and the subsequent reconciliation
calculation, post-episode spending, and ACO overlap calculation for
performance year 1. These amounts would be added together to create the
reconciliation payment or repayment amount.
Note that given our proposal to not hold EPM participants
financially responsible for repayment for the first performance year,
during the reconciliation process for performance year 2, the
subsequent reconciliation calculation amount (for performance year 1)
would be compared against the performance year 1 NPRA to ensure that
the sum of the NPRA calculated for performance year 1 and the
subsequent reconciliation calculation for year 1 is not less than zero.
Likewise given our proposal to not hold EPM participants financially
responsible for repayment for episodes ending during performance year 2
(NDR), during the reconciliation process for performance year 3, the
subsequent reconciliation calculation amount for performance year 2
(NDR) would be compared against the performance year 2 (NDR) NPRA to
ensure that the sum of the NPRA calculated for performance year 2 (NDR)
and the subsequent reconciliation calculation for performance year 2
(NDR) is not less than zero.
For performance year 2 (DR) and performance years 3 through 5,
though, we propose that Medicare would hold the participant responsible
for repaying part or all of the absolute value of the repayment amount,
as proposed in section III.D.2.c. of this proposed rule, following the
rules and processes for all other Medicare debts. Table 11 illustrates
a simplified example of how the subsequent reconciliation calculation
may affect the following year's reconciliation payment. Note that this
example assumes the EPM participant is not responsible for post-episode
spending or ACO overlap for performance year 1.
Table 11--Sample Reconciliation Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
Difference
Performance between PY1 Reconciliation
Performance year 1 subsequent Performance payment made to
year 1 (2017) subsequent reconciliation year 2 (2018) EPM
NPRA reconciliation calculation and NPRA * participant in
calculation NPRA quarter 2 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital A......................................................... $50,000 $40,000 ($10,000) $25,000 $15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note the calculation of NPRA for performance year 2 represents the combined amounts of the NPRA for performance year 2 (NDR) and performance year 2
(DR).
The second column represents the NPRA calculated for performance
year 1, meaning that EPM participant Hospital A's aggregated episode
payment was $50,000 below the sum of quality-adjusted target prices for
all of Hospital A's EPM episodes. The third column represents the
subsequent reconciliation calculation, indicating that when calculating
actual EPM-episode payments during performance year 1 a second time, we
determined that Hospital A's aggregated EPM-episode payment was $40,000
below the sum of quality-adjusted target prices for all of Hospital A's
EPM episodes, due to claims run out, accounting for model overlap, or
other reasons. The fourth column represents the difference between the
subsequent reconciliation calculation and the raw NPRA calculated for
performance year 1. This difference is then combined with the amount in
the fifth column to create the reconciliation payment amount for PY2,
which is reflected in the sixth column.
This reconciliation process would account for overlap between the
CJR model and other CMS models and programs as discussed in section
III.D.6.b of this proposed rule, and would also involve updating
performance year EPM-episode claims data. We also note that in cases
where an EPM participant has appealed one or more of its EPM quality
measure results through the HIQR Program appeal process (which is not
part of the proposed EPM appeals process), where such HIQR Program
appeal findings would result in a different effective discount factor
for the EPM participant to calculate the quality-adjusted target prices
from EPM-episode benchmark prices, the subsequent reconciliation
calculation would account for these changes as well.
For example, for performance year 1 for these EPMs in 2017, we
would capture claims submitted by March 1, 2018, and reconcile payments
for EPM participants approximately 6 months after the end of the
performance year 1 in quarter 2 of calendar year 2018. We would carry
out the subsequent reconciliation calculation in the following year in
quarter 2 of calendar 2019, simultaneously with the reconciliation
process for the second performance year, 2018. Table 12 displays the
reconciliation timeframes for the EPMs.
Table 12--Proposed Timeframe for Reconciliation for EPMs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Second Calculation amounts
reconciliation, ACO included in
EPM performance year EPM performance period Reconciliation claims NPRA calculation overlap, and post- reconciliation
submitted by episode spending payment and repayment
calculations amounts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 1 *........................... Episodes beginning on March 1, 2018......... Q2 2018.............. March 1, 2019........ Q2 2019
or after July 1, 2016
and ending through
December 31, 2017.
[[Page 50867]]
Year 2............................. Episodes ending March 1, 2019......... Q2 2019.............. March 1, 2020........ Q2 2020
January 1, 2018
through December 31,
2018.
Year 3............................. Episodes ending March 1, 2020......... Q2 2020.............. March 2, 2021........ Q2 2021
January 1, 2019
through December 31,
2019.
Year 4............................. Episodes ending March 2, 2021......... Q2 2021.............. March 1, 2021........ Q2 2021
January 1, 2020
through December 31,
2020.
Year 5............................. Episodes ending March 1, 2022......... Q2 2022.............. March 1, 2023........ Q2 2023
January 1, 2021
through December 31,
2021.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note that the reconciliation for Year 1 would not include repayment responsibility from EPM participants.
We propose this approach in order to balance our goals of providing
reconciliation payments in a reasonable timeframe, while being able to
account for overlap and all Medicare claims attributable to EPM
episodes. We believe that beginning to pull claims 2 months after the
end of the performance year would provide sufficient claims run-out to
conduct the reconciliation in a timely manner, given that our
performance year includes EPM episodes ending, not beginning, by
December 31st. We note that in accordance with the regulations at Sec.
424.44 and the Medicare Claims Processing Manual (Pub. L. 100-04),
Chapter 1, Section 70, Medicare claims can be submitted no later than 1
calendar year from the date-of-service. We recognize that by pulling
claims 2 months after the end of the performance year to conduct
reconciliation, we would not have complete claims run-out. However, we
believe that the 2 months of claims run-out would be an accurate
reflection of EPM-episode payments and consistent with the claims run-
out timeframes used for reconciliation in other payment models, such as
BPCI Models 2 and 3 and the CJR model. The alternative would be to wait
to reconcile until we have full claims run out 12 months after the end
of the performance year, but we are concerned that this approach would
significantly delay earned reconciliation payments under the EPMs.
However, we propose to conduct a subsequent reconciliation
calculation 14 months after the end of a performance year to account
for canceled episodes, post-episode spending, overlap with other CMS
models and programs, and any remaining claims available at that time.
The proposals for the annual reconciliation and subsequent
reconciliation calculation are included in Sec. 512.305 and Sec.
512.307. We seek comment on these proposals for an annual
reconciliation and subsequent calculation.
c. Reconciliation Report
For EPM participants to receive timely and meaningful feedback on
their performance under the models as well as better understand the
basis of their reconciliation payment or Medicare repayment for a given
performance year, if any, we propose to annually issue to EPM
participants a reconciliation report, similar to the CJR Reconciliation
Report we make available to CJR participants (80 FR 73408). We propose
that these reports would contain the following information:
Information on the EPM participant's composite quality
score described in section III.E.3.a. through III.E.3.e of this
proposed rule.
The total actual episode payments for the EPM participant.
The NPRA.
Whether the EPM participant is eligible for a
reconciliation payment or must make a repayment to Medicare.
The NPRA and subsequent reconciliation calculation amount
for the previous performance year, as applicable.
The post-episode spending amount and ACO overlap
calculation for the previous performance year, as applicable.
The reconciliation payment or repayment amount.
For performance year 2, we propose that the reconciliation report
would include information separately for the performance year 2 (NDR)
and performance year 2 (DR) portions of that year.
As discussed in section III.D.8 of this proposed rule, EPM
participants would review their reconciliation report and would be
required to provide written notice of any error, in a calculation error
form that must be submitted in a form and manner specified by CMS.
Unless the EPM participant provides such notice, the reconciliation
report would be deemed final within 45 calendar days after it is
issued, and CMS would proceed with payment or repayment. The proposal
to issue a reconciliation report is included in Sec. 512.305(f). We
seek comments on our proposal to issue a reconciliation report to EPM
participants and what other information, if any, would be helpful to
include in this report.
6. Adjustments for Overlaps With Other Innovation Center Models and CMS
Programs
a. Overview
Three issues may arise in overlap situations that must be addressed
under EPM. First, we acknowledge that there may be circumstances where
a hospital in a geographic area selected for the AMI, CABG or SHFFT
model is also participating in BPCI for the same episode. We refer to
this as ``provider overlap.'' Second, there may be situations where a
Medicare beneficiary receives care that could potentially be counted
under more than one episode or total cost of care payment model. We
refer to this as ``beneficiary overlap.'' Finally, EPM reconciliation
payments and Medicare repayments made under Parts A and B and
attributable to a specific beneficiary's episode may be at risk of not
being accounted for by other models and programs when determining the
beneficiary's cost of care under Medicare. Therefore, a payment
reconciliation policy is necessary in order to credit the entity that
is closest to that care for the episode of care in terms of time,
location, and care management responsibility.
We establish our proposal for provider overlap at Sec. 512.100(b)
and Sec. 512.230(g). We establish our proposal for beneficiary overlap
at Sec. 512.230(f), Sec. 512.230(h), and Sec. 512.230(i). We
establish our proposal for payment reconciliation at Sec. 512.210 and
[[Page 50868]]
Sec. 512.305. We seek comment on our proposals to account for overlap
between EPMs and other CMS models or programs.
b. Provider Overlap
(1) BPCI Participant Hospitals in Geographic Areas Selected for EPMs
Provider overlap exists when a hospital in a geographic area
selected for the AMI, CABG or SHFFT model is also an episode initiator
in BPCI for an episode anchored by that EPM's DRG. BPCI is an episode
payment model testing AMI, CABG, SHFFT, and 45 other episodes in acute
care, post-acute care, or both acute care and post-acute care settings.
Similar to CJR, we propose that in the geographic areas where the
AMI, CABG and SHFFT models will be implemented, an acute care hospital
participating in BPCI Model 2 or 4 will participate in an EPM for
episodes anchored by EPM MS-DRGs that are not covered under the
hospital's current BPCI agreement. If a BPCI hospital in an EPM-
selected area withdraws from BPCI episodes anchored by EPM MS-DRGs, the
BPCI hospital will participate in the EPMs for which it was previously
excluded. This proposal promotes accountable care by ensuring
beneficiary coverage by BPCI or an EPM in selected areas.
We establish the proposal for hospitals in geographic areas
selected for EPMs that are also participating in BPCI episodes anchored
by EPM DRGs at Sec. 512.100(b). We seek comment on this proposal.
(2) BPCI Physician Group Practice (PGP) Episode Initiators in Hospitals
Participating in EPMs
It is possible that a physician in a BPCI PGP may treat a Medicare
beneficiary in a hospital participating in one or more EPM. We propose
that if a beneficiary is admitted to an EPM participant for an episode
anchored by EPM MS-DRGs covered under the PGP's BPCI agreement and the
attending or operating physician on the admission's inpatient claim is
a member of the BPCI PGP, the BPCI episode will take precedence over
the EPM episode for which the hospital would otherwise be the
accountable entity. In other words, if, for any portion of the EPM
episode, a beneficiary would also be in a BPCI PGP episode, we will
cancel or never initiate the EPM episode. For example--
A beneficiary is admitted for a CABG to an EPM participant
in the CABG model. The attending or operating physician on the
inpatient claim for the admission is in a BPCI Model 2 PGP
participating in CABG. The episode is initiated under BPCI; an EPM
episode does not initiate.
A beneficiary is admitted for an AMI to an EPM participant
in the AMI model. The beneficiary receives a PCI while hospitalized.
The attending or operating physician on the inpatient claim for the
admission is in a BPCI Model 2 PGP participating in PCI episodes but
not medical AMI episodes. A PCI episode is initiated under BPCI; an EPM
episode does not initiate.
A beneficiary is admitted for an AMI to an EPM participant
in the AMI model. A PCI was not part of the beneficiary's treatment.
The attending or operating physician on the inpatient claim for the
admission is in a BPCI Model 2 PGP participating in PCI episodes only.
The episode is initiated under the AMI model. A PCI episode under BPCI
Model 2 would not initiate unless a PCI were performed on the
beneficiary, and
A beneficiary is admitted for an AMI to an EPM participant
in the AMI model. A CABG was not part of the beneficiary's treatment.
The attending or operating physician on the inpatient claim is in a
BPCI Model 2 PGP participating in CABG episodes only. The episode is
initiated under the AMI model. A CABG episode under BPCI Model 2 would
not be initiated unless a CABG was performed on the beneficiary while
hospitalized.
We establish the proposal for BPCI PGP episode initiators in
hospitals participating in EPMs at Sec. 512.230(g). We seek comment on
this proposal.
(c) Beneficiary Overlap
(1) Beneficiary Overlap With BPCI
We also need to account for instances where a different model's
episode could initiate during an ongoing EPM episode. We propose that
any BPCI Model 2, 3 or 4 episode, regardless of its anchor DRG
exclusion status from an EPM episode definition, takes precedence over
an AMI, CABG or SHFFT episode such that it would cancel or prevent the
initiation of an AMI, CABG or SHFFT episode. For example--
If a beneficiary is in an ongoing AMI model episode and is
treated for SHFFT by a hospital, PGP physician, or post-acute care
provider participating in a BPCI SHFFT episode, the initial AMI model
episode will be canceled. The second entity will initiate a new episode
under BPCI subject to the payment rules under that model, and
If a beneficiary is in an ongoing BPCI AMI episode and is
readmitted for SHFFT to an EPM participant in the SHFFT model, the BPCI
episode would continue and the SHFFT model episode would not initiate.
Participants in BPCI have an expectation that eligible episodes
will be part of the BPCI model test, whereas based on our proposal EPM
participants would be aware that episodes may be canceled when there is
overlap with BPCI episodes. We aim to preserve the integrity of ongoing
model tests without introducing major modifications that could make
evaluation of existing models more challenging. Given the current
scheduled end date for the BPCI, we are proposing to give precedence to
episodes covered under BPCI Models 2, 3 and 4 initiated on or before
September 30, 2018.
We acknowledge this BPCI-EPM overlap policy differs from the CJR
beneficiary overlap policy, where a beneficiary may be in a CJR LEJR
episode and a non-LEJR BPCI episode concurrently. However, in CJR this
overlap is rare. Within the 90-day post-hospital discharge period,
included readmissions occur for less than 1 percent of LEJR
beneficiaries. In contrast, included readmissions occur for
approximately 25 percent of AMI and CABG beneficiaries. The high
incidence of included readmissions for AMI, CABG and SHFFT episodes
necessitates a different policy to avoid double-paying savings and
double-counting losses, as well as not initiating new episodes when the
readmission is a complication of care during the first episode that
could be managed.
We considered alternative options for dealing with situations in
which a beneficiary in an EPM episode could also be in a BPCI episode,
including allowing the first episode initiated to take precedence
regardless of the model under which it occurred. This would encourage
more accountable care, particularly with AMI, CABG, and SHFFT episodes
that are more likely to involve readmissions for complications than
generally occur with LEJR. However, preventing BPCI episodes from being
initiated, particularly those initiated by post-acute care providers
which, by definition, occur after an anchor hospitalization, could
substantially reduce the number of such episodes and our ability to
fully test BPCI. Moreover, operational challenges due to different
timelines for payment reconciliation are of concern.
We establish the proposal for beneficiary overlap with BPCI at
Sec. 512.230(h). We seek comment on this proposal.
[[Page 50869]]
(2) Beneficiary Overlap With the CJR Model and Other EPMs
As discussed in section III.C.4. of this proposed rule, if a
beneficiary is in a SHFFT, AMI or CABG model or CJR episode and has a
hospital readmission that is not excluded from the ongoing episode
definition and would otherwise initiate an episode in a different EPM
or the CJR model, that hospital readmission will not initiate another
episode or cancel the ongoing episode. If a beneficiary is in a SHFFT,
AMI or CABG model episode or CJR episode and has a hospital readmission
that is excluded from the ongoing episode definition and could initiate
an episode in a different EPM or the CJR model, the subsequent EPM or
CJR episode will initiate, the ongoing episode would continue, and both
episodes will occur concurrently. For example--
The CJR model episode definition does not exclude the MS-
DRGs that would initiate a SHFFT model episode. If a beneficiary is in
the CJR model and receives SHFFT at an EPM participant in the SHFFT
model during the ongoing CJR episode, the CJR episode will continue and
the SHFFT model episode will not initiate;
SHFFT model episode definition does not exclude the MS-
DRGs that would initiate a CJR LEJR episode. If a beneficiary is in the
SHFFT model and receives an LEJR at a CJR hospital during the ongoing
SHFFT episode, the SHFFT episode will continue and the CJR episode will
not initiate;
The SHFFT model episode definition does not exclude the
MS-DRGs that would initiate an AMI model episode. If a beneficiary is
in the SHFFT model and is readmitted for an AMI to an EPM participant
in the AMI model during the ongoing SHFFT model episode, the SHFFT
model episode will continue and the AMI model episode will not
initiate;
The AMI model episode definition does not exclude the MS-
DRGs that would initiate a CABG model episode. If a beneficiary is in
the AMI model and is readmitted for a CABG to the same or another EPM
participant in the CABG model during the ongoing AMI model episode, the
AMI model episode will continue and the CABG model episode will not
initiate.
We believe that an overlap policy that gives precedence to the
ongoing episode over subsequent episodes initiated during the post-
hospital discharge period, except where the second admission is
explicitly excluded, aligns with our stated goal of encouraging more
accountable care. Moreover, this policy would establish an
operationally straightforward policy for future EPMs.
We establish the proposal for beneficiary overlap with the CJR
model and other EPMs at Sec. 512.230(i). We seek comment on this
proposal.
(3) Beneficiary Overlap With Shared Savings Models and Programs
We expect many beneficiaries in an AMI, CABG or SHFFT model episode
will also be aligned or attributed to a Shared Savings Program
participant or a participant in an ACO model initiated by the CMS
Innovation Center. For the purposes of this discussion, the term ACO
will be used generically to refer to either Shared Savings Program or
Innovation Center ACO models. Shared savings payments to ACOs and
shared savings losses repaid by ACOs to CMS have the potential to
overlap with EPM reconciliation payments. As with CJR, we propose to
attribute savings achieved during an EPM episode to the EPM
participant, and include EPM reconciliation payments for ACO-aligned
beneficiaries as ACO expenditures. In order to address comments
received during rulemaking for CJR, we propose to test an alternative
strategy to address ACO overlap. Specifically, we propose to exclude
beneficiaries from EPMs who are aligned to ACOs in the Next Generation
ACO model and End Stage Renal Disease (ESRD) Seamless Care
Organizations (ESCOs) in the Comprehensive ESRD Care initiative in
tracks with downside risk for financial losses. We do not propose to
exclude beneficiaries aligned to Shared Savings Program ACOs in Tracks
1, 2, or 3 at this time. However, we seek comment on excluding
beneficiaries from EPMs that are prospectively assigned to SSP Track 3
as well as to other financial risk tracks. The Shared Savings Program
is a national program. We do not believe that testing a new approach to
addressing overlap, which could potentially disrupt ACO investments,
operations, and care redesign activities, would be appropriate at this
time prior to a test with a smaller population. We plan to monitor and
learn from the test of excluding beneficiaries prospectively assigned
to an ACO from risk tracks and consider these results and comments in
future rule-making.
Several strong considerations drive us to otherwise follow CJR
precedent for addressing ACO overlap. First, CMS continues to avoid
double payment of savings and double recoupment of losses, which is an
important principle of successful payment reform. Second, in
implementing the EPMs, there would be no additional operational effort
due to consistency in ACO overlap policies across models. In this
respect, we anticipate little to no difficulty in replicating prior
policy as new episode payment models are introduced. Third, this would
have no negative financial impact on EPM participants, an important
consideration for future EPMs. The payment reconciliation for EPM
participants is described in section III.D.5. of this proposed rule.
Therefore, we propose to follow the policy set forth in the CJR
Final Rule for accounting for overlap between EPMs and the Shared
Savings Program and ACO models other than the Next Generation ACO model
and CEC listed previously.
Additionally, for programmatic consistency among ACO models and
programs, given that our ACO models generally are tested for the
purpose of informing future potential changes to the Shared Savings
Program, we believe that the ACO model overlap adjustment policy should
be aligned with the Shared Savings Program policy. Thus, we propose
that under EPMs, we would make an adjustment to the reconciliation
amount to account for any of the applicable discount for an episode
resulting in Medicare savings that is paid back through shared savings
under the Shared Savings Program or any other ACO model, but only when
an EPM hospital also participates in the ACO and the beneficiary in the
EPM episode is also aligned to that ACO. This adjustment would be
necessary to ensure that the applicable discount under the EPM is not
reduced because a portion of that discount is paid out in shared
savings to the ACO and thus, indirectly, back to the hospital.
However, we propose not to make an adjustment under EPMs when a
beneficiary receives an AMI, SHFFT, or CABG at a hospital participating
in the corresponding EPM and is aligned to an ACO in which the hospital
is not participating. While this proposal would leave overlap
unaccounted for in such situations, we do not believe it would be
appropriate to hold responsible for repayment the hospital that managed
the beneficiary during the episode through an EPM adjustment, given
that the participant may have engaged in care redesign and reduced
spending during the EPM episode. The participant may be unaware that
the beneficiary is also aligned to an ACO. However, we recognize that
as proposed this policy would allow an unrelated ACO full credit for
the Medicare savings achieved during the episode. The evaluation of
each of the EPMs, as discussed in section IV. of this proposed rule,
would examine overlap in such
[[Page 50870]]
situations and the potential effect on Medicare savings.
We note that our proposed policy as outlined in this proposed rule
would entail CMS reclaiming from the EPM participant any discount
percentage paid out as shared savings for the Shared Savings Program or
ACO models only when the hospital is an ACO participant and the
beneficiary is aligned with that ACO, while other total cost of care
models such as the Comprehensive Primary Care Plus initiative (CPC+)
would adjust for the discount percentage in their calculations. We
believe that other ACO models in testing that share operating
principles with the Shared Savings Program should follow the same
policies as the EPM Shared Savings Program adjustment for certain
overlapping ACO beneficiaries. As the landscape of CMS models and
programs changes, we may revisit this policy through future rulemaking.
However, there are circumstances when an alternative option may be
appropriate to consider. Therefore, we are also considering an EPM-ACO
overlap policy that would exclude from EPMs beneficiaries who are
aligned to ACOs in the Next Generation ACO model and ESCOs in the
Comprehensive ESRD Care Initiative in tracks with downside risk for
financial losses. Some ACOs have successfully managed acute care and
post-acute care expenditures below regional or national mean costs, and
expressed that the current CJR and BPCI ACO overlap policies deprives
them of a key source of savings. We are aware of situations in certain
markets that seem to reduce opportunities for ACOs to achieve savings
given historic experience that indicates these particular ACOs are able
to manage the care within episodes as successfully as EPM participants.
Attributing savings to participants in episode payment models, such as
CJR participants and EPM participants under this proposed rule, creates
a problem where the ACO is accountable for coordinating a beneficiary's
care over a performance year but is not able to benefit from savings
achieved from episodes completed during the performance year. Data
shows that post-acute care spending is among the most significant
sources of savings for ACOs currently, and where they focus significant
investments.68 69
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\68\ McWilliams J, Michael Laura A, Hatfield Michael E, Chernew
Bruce E, Landon and Aaron L Schwartz. ``Early Performance of
Accountable Care Organizations in Medicare--NEJM.'' N Engl J Med.
Massachusetts Medical Society, 13 Apr. 2016. Web. 02 May 2016.
http://www.ncbi.nlm.nih.gov/pubmed/27075832.
\69\ McWilliams J, Michael Michael E. Chernew, Bruce E Landon
and Aaron L Schwartz. ``Performance Differences in Year 1 of Pioneer
Accountable Care Organizations.'' N Engl J Med. (2015); 372(20):
1927-936. Massachusetts Medical Society, 15 Apr. 2015. Web. 02 May
2016. http://www.ncbi.nlm.nih.gov/pubmed/25875195.
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Certain considerations weigh against exclusion of all ACO-aligned
beneficiaries from participation in EPM episodes. Such a blanket
exclusion would remove a large proportion of Medicare FFS beneficiaries
from the EPMs, many of whom would inevitably receive care at EPM
participants. This would dilute the power of the EPM test and
generalizability of EPM findings. Additionally, differences between ACO
beneficiary alignment algorithms do not support a blanket exclusion. It
is more operationally feasible to identify and exclude beneficiaries
who are prospectively aligned to ACOs. In retrospective alignment
models, beneficiaries may be aligned to an ACO at the end of the
performance year, before the performance year, or preliminarily aligned
to one ACO before the performance year and subsequently aligned to a
different ACO after all qualifying services are considered. In
retrospective alignment, there will be significant numbers of
beneficiaries aligned at final reconciliation to a given ACO who were
not identified as preliminarily aligned to that ACO prior to the
performance year. That is, they were identified either as unaligned to
any ACO or aligned to a different ACO. In prospective alignment models
and tracks, the list of aligned beneficiaries is available prior to the
start of the performance year and a beneficiary's alignment does not
change on the basis of his or her utilization in the performance year
(subject to various exclusions made on a quarterly basis, such as a
beneficiary's election into a Medicare Advantage plan).
Because ACOs in two-sided risk arrangements have stronger
incentives than those in one-sided risk arrangements to reduce total
cost of care, especially given the possibility of paying CMS shared
losses, we believe that ACOs in two-sided risk arrangements may be best
positioned to assume the risk associated with EPM episodes, while ACOs
in one-sided risk arrangements may be less well-positioned to do so.
ACOs in one-sided risk arrangements, such as those in the Shared
Savings Program Track 1, do not bear the risk of owing losses to CMS.
In contrast, ACOs in two-sided risk arrangements, such as the Next
Generation ACO model, are held to as much as 80 percent to 100 percent
of first dollar losses. Thus, we believe that pursuing a blanket
exclusion from EPMs of aligned beneficiaries from all ACOs would
inappropriately disadvantage EPM participants that carry significant
financial risk under EPM.
This proposed ACO overlap policy would grant ACOs in models and
tracks with the highest levels of downside risk for financial losses--
the Next Generation ACO model and tracks of the Comprehensive ESRD Care
Initiative with downside risk for financial losses--paramount financial
opportunity in exchange for accepting total cost of care responsibility
for their beneficiaries. EPM participants may still realize
opportunities to save by partnering with ACOs, but outside of the EPM
arrangement. Specifically, we refer to section IIII.I. of this proposed
rule which describes opportunities for gainsharing allowed under these
models.
This policy tests the effects of such an ACO-aligned beneficiary
exclusion policy within a broader test of the effectiveness of EPMs. We
can learn its impact on EPM participants and ACOs that have
beneficiaries excluded from EPMs, as well as ACOs that do not have
beneficiaries excluded from EPMs. This will improve our understanding
about the appropriate entity to hold accountable for the costs within
the episode. For this reason we are recommending this test be limited
to the AMI, CABG, and SHFF, and CJR models, and ACO models being
conducted under CMS' Innovation Center, and are not proposing to
implement the policy more broadly to other ACOs, such as those in the
Shared Savings Program. In proposing the exclusion of beneficiaries in
only a limited number of ACO initiatives we attempt to balance the
desire to build a new payment reform initiative while mitigating the
potential challenges to existing shared savings models and programs. We
seek comment on this proposal as well as input on extending the
proposal to CJR and other ACOs accepting two-sided risk, such as those
ACOs in the Shared Savings Program Track 3.
We have investigated CMS data related to the services under
consideration in the AMI, CABG and SHFFT models. A small fraction of
total beneficiaries aligned to ACOs qualifying for this exclusion in
fact have relevant anchor hospitalizations that would initiate an EPM
in a given calendar year. For instance, from 2013 through 2015, about
2.4 percent of beneficiaries aligned to Pioneer ACO model participants
had an anchor hospitalization that would have
[[Page 50871]]
initiated an AMI, CABG or SHFFT model.
We have considered several additional options to account for EPM-
ACO beneficiary overlap prior to proposing the strategy outlined
previously. We considered whether to split the risk, including at an
equal sharing rate, at the time of financial reconciliation between EPM
participants and ACOs when episodes included overlapping beneficiaries.
This has the advantage of mitigating the supposed ``carve out'' of ACO
expenditures, but requires CMS to arbitrarily declare a level of risk
sharing. We are also concerned about the operational feasibility of
such calculations, given that reconciliation would have to occur in
tandem, resulting in long delays in payments or recoupments for both
EPM participants and ACOs. We also considered whether to attribute to
ACOs the more favorable of either the episode-specific target price or
the actual expenditures incurred by the beneficiary during the episode
time period. However, this policy would result in significant losses to
the Medicare Trust Fund, as the double payment of savings/losses would
be a certainty.
We establish the proposal to exclude from the EPMs beneficiaries
who are aligned to an ACO in the Next Generation ACO Model or
Comprehensive ESRD Care Initiative at Sec. 512.230(f). We establish
the proposal to attribute savings achieved during an EPM episode to the
EPM participant, and include EPM reconciliation payments for other ACO-
aligned beneficiaries as ACO expenditures at Sec. 512.305 and Sec.
512.307. We seek comment on our proposals to account for beneficiary
overlap with shared savings models and programs.
d. Payment Reconciliation of Overlap With Non-ACO CMS Models and
Programs
In general, Per-Beneficiary Per-Month (PBPM) payments are for new
or enhanced provider or supplier services that share the goal of
improving quality of care overall and reducing Medicare expenditures
for services that could be avoided through improved care coordination.
Some of these PBPM payments may be made for services furnished to a
beneficiary that is in another Innovation Center model at the that same
time that the beneficiary is in an EPM, but the clinical relationship
between the services paid by the PBPM payments and the EPM will vary.
For purposes of this proposed rule, we consider clinically related
those services paid by PBPM payments that are for the purpose of care
coordination and care management of any beneficiary diagnosis or
hospital admission not excluded from an EPM's episode definition, as
discussed in section III.C. of this proposed rule.
As with CJR, we propose to include PBPM payments for new and
enhanced services in EPM reconciliation calculations if we determine,
on a model by model basis, that the services paid by PBPM payments are
(1) not excluded from an EPM model's episode definition; (2) rendered
during the episode; and (3) paid for from the Medicare Part A or Part B
Trust Funds. That is, we would include the clinically related services
paid by a PBPM payment if the services would not otherwise be excluded
based on the principal diagnosis code on the claim, as discussed in
section III.C. of this proposed rule. The PBPM payments for clinically
related services would not be excluded from the EPMs' historical
episodes used to calculate target prices when the PBPM payments are
made from the Part A or Part B Trust Fund, and they would not be
excluded from calculation of actual episode expenditures during an
EPM's performance period. PBPM model payments that we determine are
clinically unrelated would be excluded, regardless of the funding
mechanism or diagnosis codes on claims for those payments. We note that
in the case of PBPM model payments, principal diagnosis codes on a Part
B claim (which are used to identify exclusions from EPMs, as discussed
in section III.C. of this proposed rule) would not be the only
mechanism for exclusion of a service from an EPM. All such PBPM model
payments we determine are clinically unrelated would be excluded as
discussed in this proposed rule. Finally, all services paid by PBPM
payments funded through the Innovation Center's appropriation under
section 1115A of the Act would be excluded from the EPMs, without a
specific determination of their clinical relationship to an EPM. We
believe including such PBPM payments funded under the Innovation
Center's appropriation and not included on claims would be
operationally burdensome and could significantly delay any
reconciliation payments and repayments for the EPMs. In addition,
because these services are not paid for from the Medicare Parts A or B
Trust Funds, we are not confident that they would be covered by
Medicare under existing law. Therefore, we believe the services paid by
these PBPM payments are most appropriately excluded from the EPMs. Our
proposal for the treatment of services paid by PBPM payments in the
EPMs would pertain to all existing models with PBPM payments, as well
as future models and programs that incorporate PBPM payments. We
believe that this proposal is fully consistent with our goal of
including all related Part A and Part B services in the EPMs, as
discussed in section III.C. of this proposed rule.
As with CJR, the OCM and MCCM services and conditions are excluded
from the AMI, CABG, and SHFFT episode definitions and thus their
payments are excluded from EPM reconciliation (listed on the CMS Web
page at https://innovation.cms.gov/Files/x/cjr-pbpmexclusions.xlsx).
While the OCM will pay for new or enhanced services through PBPM
payments funded by the Medicare Part B Trust Fund, we do not believe
these services are clinically related to the EPMs. The OCM incorporates
episode-based payment initiated by chemotherapy treatment, a service
generally reported with ICD-9-CM and ICD-10-CM codes that will be
excluded from the AMI, CABG, and SHFFT episode definition in section
III.C. of this proposed rule. We believe the care coordination and
management services paid by OCM PBPM payments would be focused on
chemotherapy services and their complications, so the services would be
clinically unrelated to AMI, CABG and SHFFT model episodes. Therefore,
we propose that services paid by PBPM payments under the OCM be
excluded from the AMI, CABG and SHFFT models. Similarly, we propose to
exclude services paid by PBPM payments under the MCCM. The MCCM focuses
on providing care coordination and palliative care services for
beneficiaries with certain conditions certified as terminally ill with
a life expectancy of 6 months or less that have not elected the
Medicare hospice benefit. The MCCM seeks to test whether providing
palliative care services, without beneficiaries having to forgo
curative care, incentivizes beneficiaries to elect hospice sooner. This
is aimed at addressing the large percentage of hospice beneficiaries
who elect the hospice benefit too late to fully benefit from the range
of services that hospice has to offer at end of life. Since the purpose
of the MCCM is to test whether providing palliative care services to
beneficiaries who are otherwise eligible to elect the Medicare hospice
benefit without requiring the beneficiary to forgo curative care
results in beneficiaries electing the hospice benefit sooner, we will
not include such
[[Page 50872]]
payments in the AMI, CABG and SHFFT models' episode spending
calculations. In addition, unlike the regular hospice benefits, which
are furnished to beneficiaries in lieu of curative care and which
therefore can be coordinated during an AMI, CABG or SHFFT model
episode, the services furnished under the MCCM will be in addition to
curative services. We note that we are including such curative services
in the EPM episode, as they are consistent with our episode definition
described in III.C. of this proposed rule, but not the services
represented by the PBPM, which are provided in addition to curative
services. Beneficiaries electing the hospice benefit could have lower
episode spending because they have forgone curative care, however
beneficiaries included in the MCCM may have higher episode spending
because they are receiving both curative care and the services
represented by the PBPM. We do not want to create incentives that deter
providers from enrolling beneficiaries in the MCCM.
We acknowledge there may be new models that could incorporate a
PBPM payment for new or enhanced services. We would plan to make our
determination about whether services paid by a new model PBPM payment
that is funded under the Medicare Trust Funds are clinically related to
EPM episodes through the same sub regulatory approach that we are
proposing to use to update the episode definitions (excluded MS-DRGs
and ICD-CM diagnosis codes). We would assess each model's PBPM payment
to determine if it would be primarily used for care coordination or
care management services for excluded clinical conditions in the EPMs
based on the standards we propose to use to update EPM episode
definitions that are discussed in section III.C. of this proposed rule.
If we determine that a PBPM payment would primarily be used to pay
for services to manage an excluded clinical condition, we would exclude
the PBPM payment from the EPM on the basis that it pays for unrelated
services. If we determine that the PBPM payment could primarily be used
for services to manage an included clinical condition, we would include
the PBPM payment in the EPM if the diagnosis code on the claim for the
PBPM payment was not excluded from the episode, following our usual
process for determining excluded claims for Part B services in
accordance with the EPM episode definitions discussed in section III.C.
of this proposed rule. We would post our proposed determination about
whether the PBPM payment would be included in the episode to the CMS
Web site to allow for public input on our planned application of these
standards, and then adopt changes to the overlap list with posting to
the CMS Web site of the final updated list after our consideration of
the public input.
The payment reconciliation is described in section III.D.5. of this
proposed rule. As with CJR, it is important that other models and
programs in which providers are accountable for the total cost of care
be able to account for the full Medicare payment, including EPM-related
reconciliation payments and repayments as described in section III.D.5.
of this proposed rule, for beneficiaries who are also in EPM episodes.
We establish the proposal for accounting for non-ACO services and
payments in the EPM reconciliation process at Sec. 512.210. We seek
comment on this proposal.
7. Limits or Adjustments to EPM Participants' Financial Responsibility
a. Overview
We recognize that hospitals that would be designated for
participation in the proposed EPMs currently vary with respect to their
readiness to function under an EPM with regard to their organizational
and systems capacity and structure, as well as their beneficiary
population served. Some EPM participants may be more quickly able to
demonstrate high quality performance and savings than others, even
though we proposed that the EPM-episode benchmark prices be based
predominantly on the hospital's own historical EPM-episode utilization
in the early years of the EPMs. We also note that providers may be
incentivized to excessively reduce or shift utilization outside of an
EPM's episode by the proposed payment policies of the EPMs. In order to
mitigate any excessive repayment responsibility for EPM participants or
reduction or shifting of care outside an EPM episode, especially
beginning in performance year 2 of the EPMs when we propose to begin to
phase in responsibility for repaying Medicare for excess EPM-episode
payments, we propose several specific policies as follows.
b. Limit on Actual EPM-Episode Payment Contribution to Repayment
Amounts and Reconciliation Payments
(1) Limit on Actual EPM-Episode Payment Contribution to Repayment
Amounts
As discussed in section III.D.3.d. of this proposed rule regarding
our proposed pricing adjustment for high payment EPM episodes, EPM
participants would not bear financial responsibility for actual EPM-
episode payments greater than a ceiling set at 2 standard deviations
above the mean regional EPM-episode payment. Nevertheless, EPM
participants would begin to bear repayment responsibility beginning
performance year 2 (DR) for those EPM episodes where actual EPM-episode
payments are greater than the EPM quality-adjusted target prices up to
the level of the regional EPM-episode ceiling. When aggregated across
all EPM episodes in a model, the total money owed to Medicare by an EPM
participant for actual EPM-episode payments above the applicable EPM
quality-adjusted target price could be substantial if a hospital's EPM
episodes generally had high payments. As an extreme example, if a
hospital had all of its EPM episodes paid at 2 standard deviations
above the mean regional EPM-episode payment, the EPM participant would
need to repay Medicare a large amount of money, especially if the
number of EPM episodes was large.
To limit a hospital's overall repayment responsibility for actual
EPM-episode payments under the EPMs, (hereafter called a ``stop-loss
limit''), we propose to establish the same stop-loss limits that were
adopted for the CJR model (80 FR 73401); except, that they would apply
beginning in the second rather than first quarter of performance year
2. Specifically, we propose a 5 percent stop-loss limit in performance
year 2 (DR), a 10 percent stop-loss limit in performance year 3, and a
20 percent stop-loss limit for performance years 4 and 5 for each EPM.
That is, beginning in the second quarter of performance year 2 as we
phase in repayment responsibility, the EPM participant would owe
Medicare under each proposed EPM no more than 5 percent of the sum of
the EPM quality-adjusted target prices for all of the EPM participant's
EPM episodes during performance year 2 (DR). This responsibility
gradually phases up to 20 percent by performance year 4.
For performance year 2, the comparison against the stop loss limit
would only apply for NPRA attributable to episodes ending in
performance year 2 (DR). When we calculate the NPRA for performance
year 2 as described in section III.D.5. of this proposed rule, we would
ensure the NPRA attributable to episodes ending during performance year
2 (NDR) is not less than zero and that NPRA attributable to episodes
ending during performance year 2 (DR) does not exceed the stop-loss
limit of 5
[[Page 50873]]
percent of the sum of quality-adjusted target prices for episodes that
ended during performance year 2 (DR).
Similarly, when we conduct the subsequent reconciliation
calculation to reassess actual EPM-episode payments for performance
year 2 (which will occur concurrently with the reconciliation for
performance year 3), we would combine the performance year 2 (NDR) NPRA
and the result of the subsequent reconciliation calculation for
performance year 2 (NDR) to ensure the result is not less than zero.
Also, we would combine the performance year 2 (DR) NPRA and the result
of the subsequent reconciliation calculation for performance year 2
(DR) to ensure the stop-loss limit is not exceeded.
For performance years 3 through 5, it would not be necessary to
split the performance years to ensure that the stop-loss limit is not
exceeded as a single stop-loss limit would apply in each year. For
example, when we calculate the NPRA for performance year 3, as
described in section III.D.5. of this proposed rule, we would ensure
the NPRA does not exceed the stop-loss limit of 10 percent of the sum
of quality-adjusted target prices. Similarly when we conduct the
subsequent reconciliation calculation to reassess actual EPM-episode
payments for performance year 3 (which will occur concurrently with the
reconciliation for performance year 4), we would combine the
performance year 3 NPRA and the result of the subsequent reconciliation
calculation for performance year 3 to ensure the stop-loss limit is not
exceeded.
Note that, as described in sections III.D.5.b. and III.D.7.e., the
result of the post-episode spending calculation and ACO overlap
calculation that would occur concurrently with the subsequent
reconciliation calculation for a given performance year would not be
subject to the stop-loss limit. The result of these calculations will
be added to the NPRA and subsequent reconciliation calculation to
create the repayment amount or reconciliation payment. We believe that
these limits both offer EPM participants reasonable protections while
maintaining incentives to improve care quality and efficiency. We would
note that in addition to the CJR model, we apply a similar ultimate 20
percent stop-loss limit to payments under the BPCI initiative.
The proposal to limit hospitals' overall payment responsibility
under the models is included in Sec. 512.305(c)(2)(iii)(A). We seek
comment on our proposal to limit hospitals' overall payment
responsibility.
(2) Limitation on Reconciliation Payments
We believe limits on reconciliation payments made under the
proposed EPMs would also be appropriate for several reasons. Under our
proposal, in performance year 1, EPM participants have no repayment
responsibility for excess EPM episode spending above the EPM quality-
adjusted target price. CMS bears full financial responsibility for
Medicare actual EPM-episode payments for an EPM episode that exceeds
the EPM quality-adjusted target price, and we believe our
responsibility should have judicious limits. Therefore, we believe it
would be reasonable to cap an EPM participant's reconciliation payment
due to actual EPM-episode payments for a given performance year as a
percentage of EPM-episode payment on the basis of responsible
stewardship of CMS resources. In addition, we note that beginning in
performance year 1, EPM participants would be eligible for
reconciliation payments due to the NPRA if actual EPM-episode payments
are less than the quality-adjusted target prices. This proposal for
reconciliation payments due to the NPRA provides a financial incentive
to EPM participants from the beginning of the model to manage and
coordinate care throughout the EPM episode with a focus on ensuring
that EPM beneficiaries receive the lowest intensity, medically
appropriate care throughout the EPM episode that results in high
quality outcomes. Therefore, we also believe it would be reasonable to
cap an EPM participant's reconciliation payment resulting from actual
EPM-episode payments based on concerns about potential excessive
reductions in utilization under the proposed EPMs that could lead to
beneficiary harm.
In determining what would constitute an appropriate reconciliation
payment limit due to actual episode spending (hereafter called a
``stop-gain limit''), we believe it should provide significant
opportunity for EPM participants to receive reconciliation payments for
greater episode efficiency that includes achievement of quality care
and actual EPM-episode payment reductions below the quality-adjusted
target price, while avoiding the creation of significant incentives to
sharply reduce utilization that could be harmful to EPM beneficiaries.
We also believe that establishing parallel stop-gain and stop-loss
limits is important to provide proportionately similar protections to
CMS and EPM participants for their financial responsibilities under the
EPMs as well as to protect the health of beneficiaries. Accordingly, we
propose to establish symmetrical stop-gain limits. Specifically, we
propose a 5 percent stop-gain limit in performance years 1 and 2, a 10
percent stop-gain limit in performance year 3, and a 20 percent stop-
gain limit for performance years 4 and 5 for each EPM. That is, in
performance year 1 as we phase in the stop-gain limits, the
reconciliation payment that the EPM participant would be eligible to
receive under each proposed EPM would be no more than 5 percent of the
sum of the EPM quality-adjusted target prices for all of the EPM
participant's EPM episodes during the performance year. This limit
gradually phases up to 20 percent by performance year 4. As indicated
in the CJR Final Rule, we want to ensure that any savings achieved by
EPM participants in the early years of the EPM are not due to random
variation, and that changes undertaken to improve efficiency include
achievement in care quality and not sharp decreases in utilization that
could be harmful to beneficiaries (80 FR 73402).
We clarify that, as with the stop-loss limit as discussed in this
section, we propose that we would determine whether an EPM participant
has met the stop-gain limit by assessing the NPRA and subsequent
reconciliation for a given performance year, if any. We believe this
approach aligns with our goal to place limits on the amount a
participant may earn as a reconciliation payment due to reduced actual
EPM-episode payments.
We would also note that we plan to monitor beneficiary access and
utilization of services and the potential contribution of the stop-gain
limit to any inappropriate reduction in EPM- episode services. We refer
to section III.G. of this proposed rule for our proposals on monitoring
and addressing hospital performance under the proposed EPMs.
The proposal to establish a cap on an EPM participant's
reconciliation payment due to actual EPM-episode payments for a given
performance year as a percentage of EPM-episode payment is included in
Sec. 512.305(c)(2)(iii)(B). We seek comment on this proposed cap.
c. Additional Protections for Certain EPM Participants
(1) Proposed Policies for Certain EPM Participants to Further Limit
Repayment Responsibility
While the aforementioned proposals generally provide additional
safeguards to ensure that EPM participants would have limited repayment
responsibility due to the raw NPRA, we are proposing
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additional protections for certain groups of EPM participants that may
have a lower risk tolerance and less infrastructure and support to
achieve efficiencies for high-payment EPM episodes. Specifically, we
are proposing additional protections for rural hospitals, SCHs,
Medicare Dependent Hospitals, and Rural Referral Centers (RRCs). We
note that these categories of hospitals often have special payment
protections or additional payment benefits under Medicare because we
recognize the importance of preserving Medicare beneficiaries' access
to care from these hospitals.
For the purpose of these models, we propose to define a Rural
Hospital as an IPPS hospital that is either located in a rural area in
accordance with Sec. 412.64(b) or in a rural census tract within an
MSA defined at Sec. 412.103(a)(1) or has reclassified to rural in
accordance with Sec. 412.103.
We propose to define a Sole Community Hospital as it is defined in
Sec. 412.92. That is, hospitals paid under the IPPS can qualify for
SCH status if they meet one of the following criteria:
Located at least 35 miles from other like hospitals.
Located in a rural area, located between 25 and 35 miles
from other like hospitals, and no more than 25 percent of residents or
Medicare beneficiaries who become hospital inpatients in the hospital's
service area are admitted to other like hospitals located within a 35-
mile radius of the hospital or the hospital has fewer than 50 beds and
would meet the 25 percent criterion if not for the fact that some
beneficiaries or residents were forced to seek specialized care outside
of the service area due to the unavailability of necessary specialty
services at the hospital.
Hospital is rural and located between 15 and 25 miles from
other like hospitals but because of local topography or periods of
prolonged severe weather conditions, the other like hospitals are
inaccessible for at least 30 days in each of 2 out of 3 years.
Hospital is rural and the travel time between the hospital
and the nearest like hospital is at least 45 minutes.
We propose to define a Medicare Dependent Hospital (MDH) as it is
defined in Sec. 412.108. That is, an MDH is a hospital that meets the
following criteria:
Located in a rural area.
Has 100 beds or less.
Is not a SCH.
Sixty percent of the hospital's inpatient days or
discharges were attributable to individuals entitled to Medicare Part A
benefits during specified time periods as provided in Sec. 412.108.
We propose to define a Rural Referral Center as it is defined in
Sec. 412.96. Specifically, RRCs are defined as IPPS hospitals with at
least 275 beds that meet the following criteria:
Fifty percent of the hospital's Medicare patients are
referred from other hospitals or from physicians who are not on the
staff of the hospital.
At least 60 percent of the hospital's Medicare patients
live more than 25 miles from the hospital.
At least 60 percent of all services the hospital furnishes
to Medicare patients are furnished to patients who live more than 25
miles from the hospital.
If a hospital does not meet these criteria, a hospital can also
qualify for RRC status if a hospital meets the following criteria:
For specified period of time, the hospital has a case-mix
that equals at least the lower of the median case mix index (CMI) value
for all urban hospitals nationally; or the median CMI value for urban
hospitals located in its region, excluding those hospitals receiving
indirect medical education payments.
Its number of discharges is at least--
++ 5,000 (or 3,000 for an osteopathic hospital); or
++ The median number of discharges for urban hospitals in the
census region in which it is located, set by the CMS through IPPS
rulemaking.
Additionally, a hospital must meet one of the following
criteria:
++ More than 50 percent of its active medical staff are specialists
who meet the conditions specified at Sec. 412.96(c)(3).
++ At least 60 percent of all discharges are for inpatients who
reside more than 25 miles from the hospital.
++ At least 40 percent of all inpatients treated are referred from
other hospitals or from physicians who are not on the hospital's staff.
Additional information on these hospitals can be found in the CJR
Final Rule at 80 FR 73403 through 73405.
In the CJR Final Rule, we established the same stop-gain limits for
these hospitals as for hospitals in general (that is, 5 percent in
performance years 1 and 2, 10 percent in performance year 3, and 20
percent in performance years 4 and 5); however, we limited losses for
rural hospitals, SCHs, Medicare Dependent Hospitals and RRCs to 3
percent in performance year 2, and 5 percent in performance years 3
through 5 (80 FR 73406). In that Final Rule, we noted that these
hospitals can face unique challenges that do not exist for most other
hospitals. For example, these hospitals may be the only source of
healthcare services for beneficiaries or certain beneficiaries living
in rural areas, and may be in areas with fewer providers including
fewer physicians and post-acute care facilities. Further, these
hospitals may have more limited options in coordinating care and
reducing spending while maintaining quality of care. We continue to
believe that urban hospitals may not have similar concerns as they are
often in areas with many other providers and have a greater opportunity
to develop efficiencies under the EPMs. Given these circumstances, for
the CJR model we determined that we should have a more protective stop-
loss limit policy for these hospitals. Given the similarity between the
CJR model and the proposed EPMs, we have similar concerns, which we
believe should be addressed by establishing greater protections for
these hospitals when they are EPM participants. Accordingly, we are
proposing the same stop-loss thresholds for these hospitals
participating in the proposed EPMs as were adopted for the CJR model
except that the thresholds would begin in performance year 2 (DR)--
specifically, 3 percent in performance year 2 (DR), and 5 percent for
performance years 3 through 5 for each EPM.
The proposal to establish separate financial loss limits for
certain hospitals that could be less able to tolerate risk is included
in Sec. 512.305(c)(2)(iii)(C). We seek comment on our proposed limit
on financial loss for these hospitals.
(2) Considerations for Hospitals Serving a High Percentage of
Potentially Vulnerable Populations
In addition to the aforementioned hospitals, we recognize that
other EPM participants, for which we do not propose additional
protections, could also face factors affecting their ability to achieve
savings under the proposed EPMs, and that these factors could be
unrelated to their practice patterns but instead could reflect the EPM
participants' responsibilities for a relatively high percentage of
potentially vulnerable populations with higher than average historical
spending and/or less opportunities for efficiencies. For example, this
could include hospitals that serve a relatively high percentage of
beneficiaries that are dually eligible for both Medicare and Medicaid
or whose total Medicare payments include a relatively high proportion
of disproportionate share hospital payments under 1886(d) (5) (F) of
the Act. Some of these hospitals are located in rural areas and would
thus likely be
[[Page 50875]]
classified as a type of hospital for which we propose additional
protections. However, most hospitals that serve a relatively high
percentage of beneficiaries that are dually eligible for both Medicare
and Medicaid or whose total Medicare payments include a relatively high
proportion of disproportionate share hospital payments are located in
urban areas, and very few are classified as a rural hospital, RRC, MDH,
or SCH that would be subject to the additional protections we propose.
For the first 2 performance years of the EPMs, where quality-adjusted
target prices are set predominantly based on EPM-participant hospital-
specific data, factors affecting these hospitals may be of less concern
than in the final 3 performance years of the EPMs where pricing is
either predominantly or totally based on regional data.
The potential challenges posed by these kinds of factors is
highlighted in Section 2(d) of the Improving Medicare Post-Acute Care
Transformation ``IMPACT'' Act of 2014 (Pub. L. 113-183). Specifically,
Section 2(d) requires the Secretary to conduct a study that examines
the effect of individuals' socioeconomic status, including their
Medicaid eligibility, on quality measures and resource use and other
measures for individuals under the Medicare program, in recognition
that less healthy individuals may require more intensive interventions.
The Secretary is required to submit a report on the results of this
study within 2 years of enactment of the IMPACT Act. The IMPACT Act
also requires the Secretary to conduct a second study that examines the
impact of various risk factors, as well as race, health literacy,
limited English proficiency (LEP), and Medicare beneficiary activation,
on quality measures and resource use and other measures under the
Medicare program in order to recognize that less healthy individuals
may require more intensive interventions. The Secretary must submit a
report on the results of this study within 5 years of enactment of the
IMPACT Act.
If these studies find a relationship between the factors examined
in the studies and quality measures and resource use and other
measures, then the Secretary shall provide recommendations for, among
other things, how CMS should account for such factors in quality
measures, resource use measures, and other measures under Medicare; and
in determining payment adjustments based on such measures in other
applicable provisions related to the program. Likewise, taking into
account these studies and their recommendations as well as other
relevant information, the Secretary is required to routinely, as
determined appropriate and based on an individual's health status and
other factors, assess appropriate adjustments to quality measures,
resource use measures, and other measures under the Medicare program;
and assess and implement appropriate adjustments to Medicare payments
based on these measures. The Assistant Secretary for Planning and
Evaluation is responsible for these studies and a report on the results
of the first one is forthcoming. Upon issuance of these studies'
reports, we plan to consider their results as we implement the proposed
EPMs. We also plan to monitor the influence of beneficiary
characteristics such as socioeconomic status on EPM participants'
performance during our implementation and evaluation of the EPMs. Given
that the performance of EPM participants would be compared largely
against their own historical episode cost performance data for the
first 2 years of the models, we do not anticipate that the
aforementioned factors should materially affect participants' ability
to achieve savings. However, as we increasingly begin to rely more on
regional cost performance data to determine episode benchmarks and
quality-adjusted target prices in performance year 3, these factors
could become more germane. Thus, in the event we identify the need for
adjustments, we could consider proposing additional policies through
subsequent rulemaking. Additionally, we plan to use information
collected as part of our efforts to monitor beneficiary access to care
and quality of care as discussed in sections III.G.4. and III.G.5. of
this proposed rule to inform if potential adjustments would be needed
in future years of the model.
Protections for EPM participants are discussed in section
III.D.7.b.(1) of this proposed rule. We seek comment about all issues
specific to hospitals serving a high percentage of potentially
vulnerable populations and their opportunities to advance the goals of
the EPMs. In particular, we seek comment, including data analysis,
about approaches to identifying these hospitals; their opportunities to
achieve high quality episode performance; specific considerations about
their opportunities to achieve efficient care for the clinical
conditions included in the AMI, CABG, and SHFFT models; potential
approaches to risk adjustment as elaborated upon in section
III.D.4.b.(2)(d) of this proposed rule; potential approaches to
additional protections that could be considered for the future modeled
after our proposals in section III.D.7.b.(1) of this proposed rule for
certain other EPM participants or other alternatives; and evaluation
methodologies to ensure that we include appropriate comparison groups
and monitor and evaluate the most relevant outcomes.
d. Application of Stop-Gain and Stop-Loss Limits
Because hospitals could be participating in the proposed AMI, CABG,
and SHFFT models concurrently with the CJR model, an additional
consideration concerns the level at which the stop-loss and stop-gain
thresholds would be applied, for example, at the hospital level, as is
currently the case for the CJR model, or at some other level, for
example, at the model level. Our intention is to establish appropriate
incentives and protections for hospitals under the proposed EPMs and
the CJR model without creating unnecessary administrative complexity.
This issue becomes especially relevant to the proposed EPMs and CJR
model given that the CJR model and proposed EPMs would be operating at
different points within their performance periods. That is, episodes
under the proposed EPMs would always lag 1 performance year behind
those in the CJR model. Thus, SHFFT model participants that would begin
the first SHFFT model performance year in 2017 would already be
participating in their second performance year under the CJR model.
Consequently, in this example, a stop-loss limit could apply to the
performance year 2 episodes under the CJR model but not to the
performance year 1 SHFFT model episodes under the SHFFT model as SHFFT
model participants would not have repayment responsibility in SHFFT
model performance year 1 under our proposal. In contrast, for this
example, the stop-gain limits would be the same for both the SHFFT and
CJR model since the limit for both performance year 1 and 2 would be 5
percent.
Continuing with this example for a later performance year
(performance year 4 for the CJR model and performance year 3 for the
SHFFT model), any stop-loss limits that applied would be different.
That is, the stop-loss limits for the CJR model episodes in performance
year 4 would be 20 percent in contrast to the 10 percent stop-loss
limit that would apply to the SHFFT model episodes in performance year
3. The proposed stop-gain limits would likewise diverge in this example
as they
[[Page 50876]]
are proposed to be symmetrical with the stop-loss limits.
Given these differences, we considered two options for setting
stop-gain and stop-loss limits for hospitals participating in more than
one of the AMI, CABG, SHFFT, and CJR models. Under the first option, we
would determine stop-loss and stop-gain limits, in total, at the
participant level based on weighted thresholds. Specifically, CMS would
calculate a single weighted stop-loss/gain threshold based on the total
spending under each model. Thus, using the aforementioned example where
CJR model episodes would be in performance year 4 of their model and
SHFFT model episodes would be in performance year 3, assuming 50
percent of total spending under the CJR and SHFFT models is for CJR
model episodes and the remaining 50 percent is for SHFFT model
episodes, the weighted stop-loss limit for the two models at the
hospital level would be 15 percent: (0.50 x 0.20 for CJR model
episodes) + (0.5 x 0.10 for SHFFT model episodes) = 0.15. Although this
option would allow the application of a single stop-loss threshold to a
hospital's total repayment under the models, we are concerned that
computing a single limit such as this could either dilute or magnify
the intended protections of the stop-loss limit under each model. As
such, a hospital that would have been protected from repayment
exceeding 10 percent of its SHFFT model quality-adjusted target prices
multiplied by the number of SHFFT model episodes for performance year 3
would only be protected for costs above the higher 15 percent level.
Conversely, a hospital that would have been protected only for
repayment above 20 percent of its CJR model quality-adjusted target
prices multiple by the number of CJR model episodes for performance
year 3 would be protected against repayment above the lower 15 percent
threshold.
Alternatively, we considered establishing stop-loss and stop-gain
thresholds at the model level; that is, separately for each of the AMI,
CABG, and SHFFT models, in addition to the limits that already exist
for the CJR model. Under this option, we would separately apply the
CJR-applicable stop-loss and stop-gain limits to CJR model episodes,
the AMI-applicable limits to AMI model episodes, and so forth. Thus,
considering the aforementioned example, the stop-loss limit for CJR
model episodes in performance year 4 would be 20 percent for the
hospital's CJR model episodes, while the stop-loss limit for SHFFT
model episodes for performance year 3 would be 10 percent. While we
might choose to aggregate these amounts to conduct a single financial
transaction with a hospital participating in more than one model, we
believe this option that would apply stop-loss and stop-gain limits at
the model level for hospitals participating in more than one model is
superior to first option in that it better maintains appropriate
incentives and protections under each of the models.
The proposal to establish stop-gain and stop-loss limits at the
model level is included in Sec. 512.305(c)(2)(iii)(D). We seek comment
on our proposal to establish stop-gain and stop-loss limits at the
model level.
e. EPM Participant Responsibility for Increased Post-Episode Payments
We note that while episodes under the proposed EPMs would extend 90
days post-discharge from the anchor or chained anchor hospitalization,
some EPM participants may have an incentive to withhold or delay
medically-necessary care until after an EPM episode ends to reduce its
actual EPM-episode payments. This inappropriate shifting could include
both those services that are related to the episode (for which the
hospital would bear financial responsibility as such services would be
included in the actual EPM-episode payment calculation) and those that
are unrelated (which would not be included in the actual EPM-episode
payment calculation), because an EPM participant engaged in shifting of
medically-necessary services outside the EPM episode for potential
financial reward may be unlikely to clearly distinguish whether the
services were related to the EPM episode or not in the hospital's
decisions.
We believe that this inappropriate shifting would not be typical,
especially given the relatively long EPM episode duration. However, in
order to identify and address inappropriate shifting of care, we
propose to calculate for each EPM performance year the total Medicare
Parts A and B expenditures in the 30-day period following completion of
each EPM episode for all services covered under Medicare Parts A and B,
regardless of whether the services are included in the proposed EPM
episode definition (sections III.C.3. and III.C.4 of this proposed
rule). This proposal is consistent with our processes for BPCI Model 2
and the CJR model (80 FR 73407 through 73408).
We propose that the post-episode spending calculation for a
performance year would occur at the same time we perform the subsequent
reconciliation calculation for that same year. We believe this
timeframe will allow sufficient time for claims run out in order to set
a reliable regional threshold for determining the post-episode
spending. For example, we would conduct reconciliation for performance
year 1 in the spring of 2018. The post-episode spending calculation for
performance year 1 would occur during the next reconciliation process
(spring 2019), when we conduct the subsequent reconciliation
calculation for performance year 1 and account for overlap with other
models and programs.
Our proposed calculation would include prorated payments for
services that extend beyond the EPM episode as discussed in section
III.D.3.c. of this proposed rule. Specifically, we would identify
whether the average 30-day post-episode spending for an EPM participant
in any given EPM performance year is greater than 3 standard deviations
above the regional average 30-day post-episode spending, based on the
30-day post-episode spending for episodes attributed to all regional
hospitals participating in the EPM in the same region as the EPM
participant. We propose that if the EPM participant's average post-
episode spending exceeds this threshold, the EPM participant would
repay Medicare for the amount that exceeds such threshold. We note that
an EPM participant's responsibility for post-episode spending would not
be subject to the stop-loss and stop-gain limits proposed in section
III.D.7.b. of this proposed rule. Although we believe cases in which an
EPM participant would be responsible for repayment of post-episode
spending that exceed the threshold would be rare, our intention is to
identify and hold EPM participants responsible for situations in which
those participants have significantly increased spending on services in
the 30 days following the end of an EPM episode in order to
inappropriately shift services out of EPM episodes. We do not believe
such behavior should be subject to stop-loss limits. This policy is
consistent with our proposal for the CJR model in section V.D.1. of
this proposed rule.
Based on our experience with BPCI, we have not found that this
proposal, including our proposal to include all Medicare Parts A and B
expenditures to measure 30-day post-episode spending, would
inappropriately penalize EPM participants. To that end, however, we
believe our proposed threshold of 3 standard deviations above the
regional average is a high threshold, and we only propose that an EPM
participant would repay Medicare for the amount that
[[Page 50877]]
exceeds such threshold. We further note that those EPM participants
that are eligible for reconciliation payments in an EPM performance
year and also have average 30-day post-episode spending that is higher
than 3 standard deviations above the regional average 30-day post-
episode spending would have their reconciliation payments reduced by
the amount by which spending exceeds 3 standard deviations.
The proposals to determine if a participant's post-episode spending
30 days after the end of an episode exceeds 3 standard deviations of
average spending in their region for that period, and require those
participants exceeding that threshold to repay Medicare for the amounts
in excess of 3 standard deviations are included in Sec. 512.307(c). We
seek comment on our proposals to determine if a participant exceeds
this threshold and to repay amounts in excess of the threshold.
8. Appeals Process
a. Overview
Consistent with the BPCI initiative and CJR model, we propose to
institute appeals processes for the EPMs that would allow EPM
participants to appeal matters related to payment, CR incentive
payments, reconciliation amounts, repayment amounts, determinations
associated with quality measures affecting payment, as well as non-
payment related issues, such as enforcement matters. These matters are
discussed throughout section III.D. and III.F. respectively.
We seek comment on the proposal to institute appeals processes, in
the following discussion, for the EPMs.
b. Notice of Calculation Error (First Level Appeal)
We propose the following calculation error process for EPM
participants to contest matters related to payment or reconciliation,
of which the following is a non-exhaustive list: The calculation of the
EPM participant's reconciliation amount or repayment amount as
reflected in the reconciliation report; the calculation of the EPM
participant's CR incentive payment as reflected in the CR incentive
payment report; the calculation of NPRA; the calculation of the
percentiles of quality measure performance to determine eligibility to
receive a reconciliation payment; and the successful reporting of the
voluntary PRO THA/TKA data to adjust the reconciliation payment. EPM
participants would review their reconciliation report and CR incentive
payment report and be required to provide written notice of any error,
in a calculation error form that must be submitted in a form and manner
specified by CMS. Unless the EPM participant provides such notice, the
reconciliation report and CR incentive report would be deemed final
within 45 calendar days after it is issued, and CMS would proceed with
payment or repayment. If CMS receives a timely notice of an error in
the calculation, CMS would respond in writing within 30 calendar days
to either confirm or refute the calculation error, although CMS would
reserve the right to an extension upon written notice to the
participant. We propose that if an EPM participant does not submit
timely notice of a calculation error, that is notice within 45 calendar
days of the issuance of the reconciliation report and CR incentive
payment report the EPM participant would be precluded from later
contesting any of the following matters contained in the reconciliation
report or CR incentive payment report for that performance year; any
matter involving the calculation of the EPM participant's
reconciliation amount or repayment amount as reflected in the
reconciliation report; any matter involving the calculation of the EPM
participant's CR incentive payment as reflected in the CR incentive
payment report; any matter involving the calculation of NPRA; the
calculation of the percentiles of quality measure performance to
determine eligibility to receive a reconciliation payment; and the
successful reporting of the voluntary PRO THA/TKA data to adjust the
reconciliation payment. Given that EPM participants bear the financial
risk in the EPM model, only EPM participants may use the dispute
resolution process described in this section.
In summary, we propose the following requirements in Sec. 512.310
(a) for notice of calculation error:
Subject to the limitations on review in subpart D of this
part, if an EPM participant wishes to dispute the calculation that
involves a matter related to payment, a CR incentive payment,
reconciliation amounts, repayment amounts, or determinations associated
with quality measures affecting payment, the EPM participant is
required to provide timely written notice of the error, in a form and
manner specified by CMS.
Unless the EPM participant provides such notice, CMS deems
final the reconciliation report and CR incentive payment report 45
calendar days after the reconciliation report or CR incentive payment
report is issued and proceeds with the payment or repayment processes
as applicable.
If CMS receives a notice of a calculation error within 45
calendar days of the issuance of the reconciliation report or CR
incentive payment report, CMS responds in writing within 30 calendar
days to either confirm that there was an error in the calculation or
verify that the calculation is correct, although CMS reserves the right
to an extension upon written notice to the EPM participant.
Only EPM participants may use the notice of calculation
error process described in this part.
We seek comment on the proposed notice of calculation error
requirements.
c. Dispute Resolution Process (Second Level of Appeal)
We propose the following dispute resolution process. First, we
propose that only an EPM participant may utilize the dispute resolution
process. Second, in order to access the dispute resolution process a
participant must have timely submitted a calculation error form, as
previously discussed, for any matters related to payment. We propose
these matters would include any amount or calculation indicated on a
reconciliation report or CR incentive payment report, including
calculations not specifically reflected on a reconciliation report or
CR incentive payment report but which generated figures or amounts
reflected on a reconciliation report or a CR incentive payment report.
The following is a non-exhaustive list of the matters we propose would
need to be first adjudicated by the calculation error process as
previously detailed: Calculations of reconciliation or repayment
amounts; calculation of CR incentive payment amounts; calculations of
NPRA; and any calculations or percentile distribution involving quality
measures that we propose could affect reconciliation or repayment
amounts. If an EPM participant wants to engage in the dispute
resolution process with regard to one of these matters, we propose it
would first need to submit a calculation error form. Where the EPM
participant does not timely submit a calculation error form, we propose
the dispute resolution process would not be available to the EPM
participant with regard to those matters for the reconciliation report
or CR incentive payment report for that performance year.
If the EPM participant did timely submit a calculation error form
and the EPM participant is dissatisfied with CMS's response to the EPM
participant's notice of calculation error, the EPM participant would be
permitted to
[[Page 50878]]
request reconsideration review by a CMS reconsideration official. The
reconsideration review request would be submitted in a form and manner
and to an individual or office specified by CMS. The reconsideration
review request would provide a detailed explanation of the basis for
the dispute and include supporting documentation for the EPM
participant's assertion that CMS or its representatives did not
accurately calculate the NPRA, the CR incentive payment, or post-
episode spending amount in accordance with EPM rules. The following is
a non-exhaustive list of representative payment matters:
Calculations of NPRA, calculations of the CR incentive
payment, post-episode spending amount, target prices or any items
listed on a reconciliation report or CR incentive payment report.
The application of quality measures to a reconciliation
payment, including the calculation of the percentiles thresholds of
quality measure performance to determine eligibility to receive
reconciliation payments, or the successful reporting of the voluntary
PRO THA/TKA data to adjust the reconciliation payment.
Any contestation based on the grounds that CMS or its
representative made an error in calculating or recording such amounts.
Where the matter is unrelated to payment, such as termination from
the model, the EPM participant need not submit a calculation error
form. We propose to require the EPM participant to timely submit a
request for reconsideration review, in a form and manner to be
determined by CMS. Where such request is timely received, we propose
CMS would process the request as discussed later in this section.
We propose that the reconsideration review would be an on-the-
record review (a review of briefs and evidence only). The CMS
reconsideration official would make reasonable efforts to notify the
EPM participant in writing within 15 calendar days of receiving the EPM
participant's reconsideration review request of the date and time of
the review, the issues in dispute, the review procedures, and the
procedures (including format and deadlines) for submission of evidence
(the ``Scheduling Notice''). The CMS reconsideration official would
make reasonable efforts to schedule the review to occur no later than
30 days after the date of the Scheduling Notice. The provisions at
Sec. 425.804(b), (c), and (e) (as in effect on the publication date of
this proposed rule) would apply to reviews conducted pursuant to the
reconsideration review process for EPM. The CMS reconsideration
official would make reasonable efforts to issue a written determination
within 30 days of the review. The determination would be final and
binding.
We solicit comment on our proposals related to appeals rights under
this model. The two-step appeal process for payment matters--(1)
calculation error form, and (2) reconsideration review--is used broadly
in other CMS models. We seek comment on whether we should develop an
alternative appeal process. We are also interested in whether there
should be appeal rights for reductions or eliminations of NPRA as a
result of enforcement actions, as discussed in section III.F. of this
proposed rule, and if so, whether the process for such appeals should
differ from the processes proposed here.
In summary, we propose the following requirements in Sec.
512.310(b) for the reconsideration process:
If the EPM participant is dissatisfied with CMS's response
to the notice of a calculation error, the EPM participant may request a
reconsideration review in a form and manner as specified by CMS.
The reconsideration request must provide a detailed
explanation of the basis for the dispute and include supporting
documentation for the EPM participant's assertion that CMS or its
representatives did not accurately calculate the NPRA, the
reconciliation payment, the CR incentive payment or the repayment
amount in accordance with subpart d of this part.
If CMS does not receive a request for reconsideration from
the EPM participant within 10 calendar days of the issue date of CMS's
response to the EPM participant's notice of calculation error, then
CMS's response to the calculation error is deemed final and CMS
proceeds with reconciliation payment or repayment processes, as
applicable, as described in Sec. 512.305.
The CMS reconsideration official notifies the EPM
participant in writing within 15 calendar days of receiving the EPM
participant's review request of the following:
++ The date, time, and location of the review.
++ The issues in dispute.
++ The review procedures.
++ The procedures (including format and deadlines) for submission
of evidence.
The CMS reconsideration official takes all reasonable
efforts to schedule the review to occur no later than 30 days after the
date of receipt of notification.
The provisions at Sec. 425.804(b), (c), and (e) of this
chapter are applicable to reviews conducted in accordance with the
reconsideration review process for the EPM.
The CMS reconsideration official issues a written
determination within 30 days of the review. The determination is final
and binding.
Only EPM participants may utilize the dispute resolution process
described in this subpart. We seek comment on the proposed
reconsideration process for the EPMs.
d. Exception to the Notice of Calculation Error Process and Notice of
Termination
Similar to the CJR model and BPCI initiative, if the EPM
participant contests a matter that does not involve an issue contained
in, or a calculation which contributes to, an EPM reconciliation report
or a CR incentive report, a notice of calculation error is not
required. Consistent with III.D.8(c) in this proposed rule, in
instances where a notice of calculation error is not required, for
example an EPM participant's termination from the EPM, we propose the
EPM participant provide a written notice to CMS requesting review
within 10 calendar days of the notice. CMS has 30 days to respond to
the EPM participant's request for review. If the EPM participant fails
to notify CMS, the decision is deemed final.
In summary, we propose the following requirements in Sec.
512.310(c) for an exception to the notice of calculation error process.
If the EPM participant contests a matter that does not
involve an issue contained in, or a calculation which contributes to, a
reconciliation report or CR incentive payment report, a notice of
calculation error is not required. In these instances, if CMS does not
receive a request for reconsideration from the EPM participant within
10 calendar days of the notice of the initial determination, the
initial determination is deemed final and CMS proceeds with the action
indicated in the initial determination.
In summary, we propose the following requirements in Sec.
512.310(d) for notice of termination:
If an EPM participant receives notification that it has
been terminated from the EPM and wishes to appeal such termination, it
must provide a written notice to CMS requesting review of the
termination within 10 calendar days of the notice. CMS has 30 days to
respond to the EPM participant's request for review. If the participant
fails to notify CMS, the termination is deemed final.
[[Page 50879]]
We seek comment on the proposed exception to the notice of
calculation error process and notice of termination.
e. Limitations on Review
In summary, we propose the following requirements in Sec.
512.310(e) for limitations on review:
In accordance with section 1115A(d)(2) of the Act, there
is no administrative or judicial review under sections 1869 or 1878 of
the Act or otherwise for the following:
++ The selection of models for testing or expansion under section
1115A of the Act.
++ The selection of organizations, sites, or participants to test
those models selected.
++ The elements, parameters, scope, and duration of such models for
testing or dissemination.
++ Determinations regarding budget neutrality under section
1115A(b)(3) of Act.
++ The termination or modification of the design and implementation
of a model under section 1115A(b)(3)(B) of Act.
++ Decisions to expand the duration and scope of a model under
section 1115A(c) of the Act, including the determination that a model
is not expected to meet criteria described in paragraph (e)(1) or (2)
of this section.
We seek comment on the proposed limitations on review.
III. Provisions of the Proposed Regulations
E. EPM Quality Measures, Public Display, and Use of Quality Measures in
the EPM Payment Methodology
1. Background
As discussed in the CJR model final rule, Medicare payment policy
has moved away from FFS payments unlinked to quality and towards
payments that are linked to quality of care (80 FR 73358). Through the
Medicare Modernization Act and the Affordable Care Act, we have
implemented specific IPPS programs like the HIQR Program (section
1886(b)(3)(B) of the Act), the HVBP Program (subsection (o) of section
1886), the Hospital Acquired Condition Reduction Program (HACRP)
(subsection (q) of section 1886), and the Hospital Readmissions
Reduction Program (HRRP) (subsection (p) of section 1886), where
quality of care is linked to payment. We have also implemented the
Shared Savings Program, an ACO program that links shared savings
payment to quality performance. The CJR model similarly incorporates
pay-for-performance through the potential for financial reward to
participants based on the hospital's level of quality performance,
while also including an incentive for quality improvement if the
hospital's current level of quality is relatively low (80 FR 73374).
We propose pay-for-performance methodologies similar to the CJR
model for the proposed EPMs. Specifically, we propose to financially
reward higher quality in an EPM episode by reducing the effective
discount factor used to calculate EPM quality-adjusted target prices at
reconciliation. We would establish the effective discount factor based
on the EPM participant's overall quality performance and improvement on
the EPM's quality measures as reflected in the EPM participant's EPM
composite quality score. We would calculate the EPM participant's
composite quality score for each EPM performance year at the time of
reconciliation. The EPM composite quality score would also determine
whether an EPM participant is eligible for a reconciliation payment if
savings are achieved beyond the EPM quality-adjusted target price by
setting a minimum EPM composite quality score for reconciliation
payment eligibility.
We note that we continue to believe that EPMs should include pay-
for-performance methodologies that incentivize improvements in patient
outcomes while simultaneously lowering health care spending (80 FR
73465). We believe that improved quality of care, specifically achieved
through coordination and communication among providers in conjunction
with patients and their caregivers, can favorably influence performance
on patient outcomes. Like the CJR model, we also believe that the
proposed three new EPMs would provide the opportunity for EPM
participants to improve the quality of care based on timely reported
patient experience, including communications with doctors and nurses,
and responsiveness of hospital staff (80 FR 73465). Finally, we strive
to align as many measures as possible in CMS's proposed new EPMs with
those in ongoing models and programs. Our goal is to focus provider
improvement efforts and minimize burden on EPM participants in needing
to become familiar with and report new measures, while still allowing
us to appropriately capture meaningful quality data and use it in the
EPMs' pay-for-performance methodologies.
More specifically, similar to our final decision for the CJR model,
we are not proposing to use any readmissions measures that could apply
to clinical conditions in these EPMs but that are already in place or
have been finalized for the HRRP, specifically the Hospital 30-day all-
cause risk-standardized readmission rate (RSRR) following AMI
hospitalization (NQF #0505) and the Hospital 30-day all-cause,
unplanned, RSRR following CABG surgery (NQF #2515), due to the
incentives, already in place by the HRRP, for hospitals to lower excess
readmission rates (80 FR 73479). While we consider these readmissions
measure rates to be important metrics for providing information about
AMI and CABG hospital performance in the HRRP and HIQR Program for
payment and public reporting, respectively, other proposed measures for
the AMI and CABG models support the intent of these models to reduce
actual payments in an EPM episode while ensuring that quality of care
for AMI and CABG model beneficiaries is improved.
Furthermore, while we recognize the lack of complete alignment
between EPM beneficiaries and the proposed cohorts for the EPM quality
measures, we believe the proposed measures provide meaningful
information about EPM participant quality performance and improvement
that are relevant to EPM beneficiaries. For the AMI and CABG models in
particular, beneficiaries included in the proposed episode-specific
measures would significantly overlap with beneficiaries in AMI and CABG
model episodes. We note that for purposes of the EPMs where we need to
identify episodes that are included in the EPMs, we use the terms
anchor and chained anchor hospitalization to identify hospitalizations
that initiate EPM episodes for beneficiaries whose care is included in
the EPMs. In describing the quality measures in detail in section
III.E.4. of this proposed rule, we use the term index hospitalization
to identify hospitalizations of beneficiaries whose outcomes are
included in the measures. Thus, anchor hospitalizations and index
hospitalizations would have varying degrees of overlap depending on the
specific quality measure.
Moreover, we note that hospitals are the unit of analysis for the
EPMs and that the proposed measures are hospital-centric measures, both
because these are currently available measures that are aligned with
those in other CMS programs and because one of the major goals of the
EPMs is to encourage collaboration among different types of providers
in order to achieve better care and reduced expenditures, while holding
acute care hospitals financially responsible. For further discussion of
our proposal that hospitals be
[[Page 50880]]
accountable for EPM episodes, we refer to section III.B.3. of this
proposed rule.
We recognize that there are also some gaps in the current proposed
measures relative to other settings in which patients receive care
post-hospital discharge during EPM episodes, as well as around
important complications of care for clinical conditions included in the
three models. However, we believe that these hospital-level measures
reasonably assess how well EPM participants provide care for EPM
beneficiaries since the measures, depending on the EPM, assess--(1)
important patient outcomes, including mortality as well as
complications and days of acute care following discharge from the index
hospitalization which can be costly; and (2) patients' perspectives on
their hospital experience, which include patient feedback on
communication with doctors, communication with nurses, responsiveness
of hospital staff, communication about medicines, discharge
information, cleanliness of the hospital environment, quietness of the
hospital environment, and transition to post-hospital care. As we gain
more experience with the EPMs, as well as the CJR model currently in
testing, and future EPMs, we plan to work to create a more robust set
of episode quality measures for these and future models. We will
continue to assess the evolving inventory of measures and will continue
to refine quality measures for potential future rulemaking based on
public comments, changes to the EPMs' payment methodologies,
recommendations from EPM participants and their collaborators, and new
CMS episode measure development activities as we learn more about the
impact of EPMs on quality improvement and episode efficiency. We refer
to section III.E.4.e. of this proposed rule for a discussion of
potential future EPM episode measures.
2. Selection of Proposed Quality Measures for the EPMs
a. Overview of Quality Measure Selection
The outcome and patient experience measures proposed for the EPMs
were selected in order to: (1) Promote alignment with the financial and
quality goals of the EPMs; (2) leverage hospitals' familiarity with the
measures due to their use in other CMS hospital quality programs,
including programs that tie payment to performance such as the HVBP
Program; (3) streamline EPM measures for EPM participants testing more
than one EPM; and (4) ensure consistency with CMS's priorities to
reduce AMI and CABG mortality and complications while improving patient
experience, as well as with CMS's priorities to reduce major LEJR
surgery complications while improving patient experience for SHFFT
model beneficiaries, like those in the CJR model.
b. AMI Model Quality Measures
In order to encourage care collaboration among multiple providers
of AMI model beneficiaries, we propose three required measures and one
measure that relies on voluntary data submission, in order to determine
AMI model participant episode quality performance and improvement that
would be linked to the AMI model payment methodology as discussed in
section III.E.3.f.(2) of this proposed rule. We propose the following
measures for the AMI model:
Hospital 30-Day, All-Cause, Risk-Standardized Mortality
Rate (RSMR) Following Acute Myocardial Infarction (NQF #0230) (MORT-30-
AMI).
Excess Days in Acute Care after Hospitalization for AMI
(AMI Excess Days).
HCAHPS Survey (NQF #0166).
Voluntary Hybrid Hospital 30-Day, All-Cause, Risk-
Standardized Mortality Rate Following Acute Myocardial Infarction (AMI)
Hospitalization (NQF #2473) (Hybrid AMI Mortality) data submission.
We refer to sections III.E.4.a. and d. of this proposed rule for a
detailed discussion of our proposals regarding these measures for the
AMI model, including their importance as measures of the quality-of-
care for beneficiaries treated for AMI. The proposals for the AMI model
measures are included in Sec. 512.411, and the proposals for reporting
the measures are included in Sec. 512.400. We seek comment on our
proposals for AMI model quality measures.
c. CABG Model Quality Measures
In order to encourage care collaboration among multiple providers
of CABG model beneficiaries, we propose two required measures, in order
to determine CABG model participant episode quality performance and
improvement that would be linked to the CABG model payment methodology
as discussed in section III.E.3.f.(3) of this proposed rule. We propose
the following measures for the CABG model:
Hospital 30-Day, All-Cause, Risk-Standardized Mortality
Rate (RSMR) Following Coronary Artery Bypass Graft (CABG) Surgery (NQF
#2558) (MORT-30-CABG).
HCAHPS Survey (NQF #0166).
We refer to sections III.E.4.b. and d. of this proposed rule for a
detailed discussion of our proposals regarding these measures for the
CABG model, including their importance as measures of the quality-of-
care for beneficiaries treated with CABG.
The proposals for the CABG model measures are included in Sec.
512.412., and the proposals for reporting the measures are included in
Sec. 512.400. We seek comment on our proposals for CABG model quality
measures.
d. SHFFT Model Quality Measures
In order to encourage care collaboration among multiple providers
of SHFFT model beneficiaries, we propose two required measures and one
measure that relies on voluntary data submission, in order to determine
SHFFT model participant episode quality performance and improvement
that would be linked to the SHFFT model payment methodology as
discussed in section III.E.3.f.(4) of this proposed rule. While we
recognize that none of the proposed measures specifically target the
care of SHFFT model beneficiaries, these measures are the same as those
used for the CJR model because SHFFT model episodes will be tested
along with the LEJR episodes in the CJR model (80 FR 73501 and 73507)
at mostly the same hospitals. In addition, as discussed further in
section III.E.3.e.(3) of this proposed rule, we propose to calculate a
hospital-level composite quality score that would apply to episode
payment for both the CJR and SHFFT models, consistent with our proposal
of the same measures for the two models. We believe that due to the
inclusion of beneficiaries with hip fracture in both the CJR and SHFFT
models and our desire to streamline EPM participant measure reporting,
as well as the focus of both models on major lower extremity orthopedic
surgery, the same set of quality measures can be used for both models
to incentivize quality improvement in lower extremity orthopedic
surgery care and episode efficiency. We are also considering future
measure development focused specifically on hip and femur fracture
patients. We expect that many of the physicians and other providers
collaborating with participant hospitals in the SHFFT and CJR models
will be the same, such that certain care pathways and episode
efficiencies may be coordinated for SHFFT and CJR model beneficiaries
regardless of the model, potentially resulting in quality improvement
for beneficiaries in both models. We propose the following measures for
the SHFFT model:
[[Page 50881]]
Hospital-level RSCR following elective primary THA and/or
TKA (NQF #1550) (Hip/Knee Complications).
HCAHPS Survey (NQF #0166).
Total Hip Arthroplasty (THA)/Total Knee Arthroplasty (TKA)
voluntary patient-reported outcome (PRO) and limited risk variable data
submission (Patient-reported outcomes and limited risk variable data
following elective primary THA/TKA).
We considered an alternative approach to the required quality
measures for the SHFFT model given that the proposed measures do not
specifically target the SHFFT model beneficiaries. This alternative
approach would not account for any hip-specific measures (such as,
Hospital-level RSCR following elective primary THA and/or TKA (NQF
#1550) (Hip/Knee Complications)) and would instead only measure patient
experience through the HCAHPS Survey (NQF #0166). Although there may be
some rationale for excluding measures that do not specifically target
SHFFT model beneficiaries, we do not propose this approach to SHFFT
model quality measures because we believe that it is critical to
include a measure of both clinical and patient experience outcomes in
the setting of lower extremity orthopedic surgery episodes.
Additionally, we believe that using quality measures for SHFFT model
episodes that do not align with those in the CJR model could generate
confusion at CJR model participant hospitals where we propose that the
SHFFT model be tested as discussed in section III.B.4. of this proposed
rule.
We refer to sections III.E.4.c. and d. of this proposed rule for a
detailed discussion of our proposals regarding these measures for the
SHFFT model, including their importance as measures of the quality-of-
care for beneficiaries undergoing major lower extremity joint
replacement surgery.
The proposals for the SHFFT model measures are included in Sec.
512.413, and the proposals for reporting the measures are included in
Sec. 512.400. We seek comment on our proposals for SHFFT model quality
measures.
3. Proposed Use of Quality Measures in the EPM Payment Methodologies
a. Overview of EPM Composite Quality Score Methodology
We believe that the proposed EPMs provide another mechanism for
hospitals to improve quality of care, while also achieving cost
efficiency. Incentivizing high-value care through episode payments for
AMI, CABG, and hip fracture care is a primary objective of these
proposed EPMs. Therefore, incorporating quality performance into the
episode payment structure is an essential component of the proposed
EPMs, just as it is for the CJR model (80 FR 73370). For the reasons
stated previously, we believe it is important for the AMI, CABG, and
SHFFT models to link the financial reward opportunity with performance
and improvement in the quality of care for Medicare beneficiaries
treated for AMI, CABG, and hip fracture.
As discussed in section III.D.4.a. of this proposed rule, which
outlines the pricing methodologies for EPM episodes, for each EPM
participant we propose to set an EPM-episode benchmark price for each
EPM episode. We would apply the EPM participant's effective discount
factor based on the participant's quality performance and improvement
for the EPM performance year to the EPM-episode benchmark episode price
to calculate the quality-adjusted target price for each EPM episode. We
refer to section III.E.3.f. of this proposed rule for further
discussion of the relationship between an EPM participant's quality
performance and improvement and the effective discount factor. Each EPM
episode includes an anchor hospitalization for either AMI (AMI MS-DRG
or PCI MS-DRG with AMI ICD-10-CM diagnosis code in the principal or
secondary diagnosis code position), CABG (CABG MS-DRG), or SHFFT (SHFFT
MS-DRG) and a 90-day period after discharge from the anchor or chained
anchor hospitalization. As discussed in section III.C.4.a.(5) of this
proposed rule, a chained anchor hospitalization is an anchor
hospitalization that initiates an AMI model episode and has at least
one subsequent inpatient-to-inpatient transfer. An EPM quality-adjusted
target price would represent expected spending on all related Part A
and Part B items and services furnished during EPM episodes based on
historical EPM episodes, and would incorporate the EPM participant's
effective discount factor for the EPM performance year. Participants
that achieve actual EPM-episode payments below the quality-adjusted
target price for a given performance year may be eligible for a
reconciliation payment from CMS, subject to the proposed stop-gain
limit policy as discussed in section III.D.7.b. of this proposed rule.
Participants that achieve actual EPM-episode payments that exceed the
quality-adjusted target price for a given performance year may be
required to repay Medicare a portion or all of the excess EPM-episode
spending.
We propose an EPM composite quality score methodology for linking
quality and payment in the EPMs that is similar to that methodology
finalized for the CJR model (80 FR 73363 to 73381). Similar to the CJR
model, the EPM-specific composite quality score methodology would allow
both performance and improvement on each EPM's required quality measure
to be meaningfully valued in the EPMs' pay-for-performance methodology,
incentivizing and rewarding cost savings in relation to the quality of
episode care provided by the EPM participant (80 FR 73374 and 73370).
Specifically, the EPM composite quality score is made up of the
composite performance score (which includes both patient experience and
outcome measures, including points for voluntarily reported measures)
and an improvement score.
We believe the actual level of quality performance achieved should
be most highly valued in the EPM composite quality score to reward
those EPM participants furnishing high quality care to EPM
beneficiaries, with a smaller contribution to the EPM composite quality
score made by improvement points if measure result improvement is
achieved. We acknowledge that substantial improvement on a quality
measure result is not the sole indicator that an EPM episode-of-care is
high quality; yet, the improvement spurred by the hospital's
participation in the EPM deserves to be valued as the EPM participant's
performance is moving in a direction that is good for the health of
beneficiaries. Like the CJR model, the EPMs involve a wide range of
participants that must participate if they are located in the selected
MSAs, and the participants would be starting from many different
current levels of quality performance. We note that the Shared Savings
Program utilizes a similar scoring and weighting methodology, which is
described in detail in the CY 2011 Shared Savings Program Final Rule
(see Sec. 425.502). The HVBP Program and the HACRP also utilize a
similar scoring methodology, which applies weights to various measures
and assigns an overall score to a hospital (79 FR 50049 and 50102).
Despite the small number of quality measures proposed for the EPMs, the
measures represent both clinical outcomes and patient experience, and
each carries substantial value in the EPM composite quality score.
Although performance and improvement on each measure would be
valued in the EPM composite quality score methodology, it is the EPM
participant's overall quality
[[Page 50882]]
performance under the EPM that would be considered in the pay-for-
performance approach, rather than performance on each quality measure
individually determining the financial opportunity under the EPM. The
EPM composite score methodology also provides a framework for
incorporating additional measures of meaningful outcomes for EPM
episodes in the future. Finally, while we believe that high performance
on all of the quality measures represents goals of clinical care that
should be achievable by all EPM participants that heighten their focus
on these measures, we appreciate that many participants have room for
significant improvement in their current measure performance. The EPM
composite score methodology would provide the potential for financial
reward for more EPM participants that reach overall acceptable or
better quality performance, thus incentivizing their continued efforts
to improve the quality and efficiency of EPM episodes.
We seek comment on our proposal to use an EPM-specific composite
quality score in the pay-for-performance methodologies of the AMI,
CABG, and SHFFT models.
b. Determining Quality Measure Performance
Similar to our reasoning in the CJR model, we believe that relative
measure performance for the EPM measures would be the most appropriate
way to incorporate quality performance into the EPMs because we do not
have sufficient information about participant performance to set and
use an absolute performance result on each measure (80 FR 73371).
Moreover, we believe that participants nationally are currently working
to improve their performance on the quality measures proposed for the
EPMs on an ongoing basis as these are included in other CMS programs
such as the HIQR and HVBP Programs. Therefore, while we expect that EPM
participants would have a heightened focus on performance on these
measures as a result of the financial incentives resulting from the EPM
payment methodology, we are not yet certain what performance outcomes
can be achieved under best practices.
Thus, at the time of reconciliation for an EPM performance year, we
propose to assign each EPM participant's measure point estimate from
the most recent year as discussed in section III.E.5. of this proposed
rule to a performance percentile based on the national distribution of
measure results for subsection (d) hospitals that are eligible for
payment under the IPPS reporting the measure that meet the minimum
patient case or survey count. This proposal applies to the MORT-30-AMI
(NQF #0230) and AMI Excess Days measure results for the AMI model; the
MORT-30-CABG (NQF #2558) measure result for the CABG model; the Hip/
Knee Complications (NQF #1550) measure result for the SHFFT model; and
the HCAHPS Survey (NQF #0166) measure result for all of the EPMs.
The measure-specific parameters that would apply to developing the
national distributions are displayed in Table 13.
Table 13--Requirements for Use of Subsection (d) Hospitals That Are
Eligible for Payment Under the IPPS Measure Results in Developing
National Distribution of Required Measures for EPMS
------------------------------------------------------------------------
Requirements for use in national
Measure distribution
------------------------------------------------------------------------
MORT-30-AMI (NQF #0230).............. At least 25 patient cases in the
3-year measure performance
period.
AMI Excess Days...................... At least 25 patient cases in the
3-year measure performance
period.
MORT-30-CABG (NQF #2558)............. At least 25 patient cases in the
3-year measure performance
period.
Hip/Knee Complications (NQF #1550)... At least 25 patient cases in the
3-year measure performance
period.
HCAHPS Survey (#0166)................ At least 100 completed surveys in
the 4-quarter reporting period.
------------------------------------------------------------------------
We would assign any low volume EPM participant without a reportable
value for the measure, new hospitals that are identified as EPM
participants, or EPM participants where CMS has suppressed the measure
value due to an error in the data used to calculate the measure to the
50th performance percentile of the measure result, so as not to
disadvantage an EPM participant based on its low volume or lack of
applicable cases because that participant may in actuality provide high
quality care. We believe that relative measures of quality performance
are most appropriate for the EPMs as participants continue to make
progress nationally on improving patient outcomes and experience.
Proposed measure-specific assignment of points in the EPMs' composite
quality scores based on relative quality measure performance are
discussed in sections III.E.3.e.(1), (2), and (3) of this proposed
rule.
We seek comment on our proposed overall approach to determining
quality measure performance based on assigning the EPM participant's
measure point estimate to a measure performance percentile based on the
national distribution of measure results from subsection (d) hospitals
eligible for payment under the IPPS.
c. Determining Quality Measure Improvement
Consistent with our reasoning for the CJR model, we believe it
would be important in the EPMs to directly reward EPM participants for
quality improvement, similar to the pay-for-performance policies under
other programs such as the HVBP Program and the Shared Savings Program,
in order to provide a significant incentive for quality improvement for
EPM participants at all current levels of quality performance (70 FR
73379). For the CJR model, we adopted a refinement to the composite
quality score methodology that would supplement the composite quality
score's valuing of quality performance in the pay-for-performance
methodology of the CJR model (80 FR 73379). As in the CJR model, we
believe the heightened focus on EPM episode cost and quality
performance by participants in the EPMs may lead to substantial year-
over-year quality measure improvement over the EPM performance years.
Nevertheless, we believe that the actual level of quality performance
achieved in the EPMs should be most highly valued in the EPM composite
quality score to reward those participants furnishing high-quality care
to EPM beneficiaries, with a small contribution to the composite
quality score made by improvement points if measure result improvement
is achieved. Thus, we propose adding into the EPM-specific composite
quality score up to 10 percent of the maximum value for each EPM
quality measure to which improvement could apply (excluding the
voluntary data submission measures) for those EPM participants that
demonstrate substantial improvement from the prior year's measure
performance on that measure (80 FR 73379 through 73380). The maximum
EPM composite quality score would be capped at 20 points
[[Page 50883]]
under this proposal. Proposed measure-specific assignment of points for
improvement in the EPMs' composite quality scores are discussed in
sections III.E.3.e.(1), (2), and (3).
For the AMI and CABG models, we propose to define measure
improvement differently than in the CJR model, using an approach that
is more similar to the methodologies of other CMS programs such as the
HVBP Program. The CJR model defined measure improvement for model
participants relative to a national performance distribution (80 FR
73380). In contrast, we propose to define measure improvement as any
improvement in an AMI or CABG model participant's own measure point
estimate from the previous year, regardless of the participant's
measure point estimate starting and ending values, if the AMI or CABG
model participant falls into the top 10 percent of participants based
on the national distribution of measure improvement over the 2 years
for subsection (d) hospitals that are eligible for payment under the
IPPS reporting the measure that meet the minimum patient case or survey
count. We propose this approach because it represents the greatest
confidence that we are capturing meaningful improvement on a measure by
an AMI or CABG model participant in comparison with performance changes
of other hospitals yet, unlike the CJR and proposed SHFFT model
methodologies, is founded on an AMI or CABG model participant's own
measure performance change from year-to-year. We believe that moving
toward incorporating a model participant's own measure performance
improvement in the pay-for-performance methodologies for EPMs
strengthens the incentives in the models for quality improvement,
especially for EPM participants at the lower end of current measure
performance.
For the SHFFT model, we propose to modify the definition of
improvement used in the CJR model in two ways (80 FR 73379 through
73380). First, we propose to define measure improvement as improving 2
deciles or more in comparison to the national distribution of measure
results from the prior year, based on a comparison of relative quality
measure performance over the most recent 2 years of available quality
measure result data. This is the same methodology as finalized for the
CJR model, except that it reduces the threshold for improvement from 3
deciles to 2 deciles in order to reward a broader range of improvement.
Second, we propose to award up to 10 percent of the maximum measure
performance score on the outcome and patient experience measures
described in III.E.3.e.(3) of this proposed rule, with a cap of the
SHFFT model composite quality score at 20 points. This alters the CJR
model methodology, which calculates the measure performance score,
voluntary reporting points, and measure improvement score separately
for a total potential maximum score of 22. Taken together, these two
changes bring calculation of the SHFFT model composite quality score
into greater alignment with existing CMS programs, such as the HVBP
Program, by expanding the number of SHFFT model participants eligible
for quality improvement points but reducing the number of participants
who receive both the highest quality performance score on a measure and
points for measure improvement simultaneously.
In section V.E. of this proposed rule, we propose changes to the
CJR model composite quality score calculation consistent with the SHFFT
model methodology described here, allowing use of the same definition
of quality improvement for the SHFFT and CJR models, because these
models would be tested in mostly the same hospitals. We believe this
approach would provide SHFFT model participants at all current levels
of quality performance, including those historically lagging, with
significant incentives to achieve improvement quality of care under the
SHFFT model. Using a common approach to measuring quality improvement
for the SHFFT and CJR models would provide a single participant-level
composite quality score that can be applied at reconciliation for each
model to determine the payment policies that would apply to the
participant for the CJR and SHFFT model episodes, taking into
consideration the different model performance years.
The proposals to determine quality measure improvement for the AMI,
CABG, and SHFFT models are included in Sec. 512.315(b)(3), (c)(3), and
(d)(3), respectively. We seek comment on our proposals to determine
quality measure improvement for the AMI, CABG, and SHFFT models.
d. Determining Successful Submission of Voluntary Data for AMI and
SHFFT Models (1) Hybrid AMI Mortality (NQF #2473) Voluntary Data
Similar to the CJR model, we propose that AMI model participants
that successfully submit the Hybrid AMI Mortality (NQF #2473) measure
voluntary data would be eligible for points in the AMI model composite
quality score (80 FR 73375, 73381). Encouraging collection and
submission of the Hybrid AMI Mortality (NQF #2473) measure voluntary
data through the AMI model would increase hospital familiarity with
submitting hybrid quality measures based on claims data and data
submitted from electronic health records; further develop an outcome
measure that provides meaningful information on outcomes for AMI
hospitalizations that are commonly experienced by Medicare
beneficiaries; provide another quality measure that may be incorporated
into the AMI model pay-for-performance methodology in future years,
pending successful implementation testing of the measure; and inform
the quality strategy of future payment models.
The proposed requirements for determining successful submission of
Hybrid AMI Mortality (NQF #2473) measure voluntary data are included in
Sec. 512.411(b)(2) and discussed in detail in section
III.E.4.a.(3)(vii) of this proposed rule. We seek comment on our
proposals for determining successful submission of voluntary data for
each AMI model performance year.
(2) Patient-Reported Outcomes and Limited Risk Variable Voluntary Data
Following Elective Primary THA/TKA
Like the CJR model, we propose that SHFFT model participants that
successfully submit Patient-reported outcomes and limited risk variable
voluntary data following elective primary THA/TKA be eligible for
points in the SHFFT model composite quality score (80 FR 73375, 73381).
We note that SHFFT model participants that are also participating in
the CJR model would not need to submit data twice to satisfy the
successful submission requirements of both models. If those hospitals
successfully submit voluntary data for the CJR model they would be
credited with successful submission under the SHFFT model.
The proposed requirements for determining successful submission of
Patient-reported outcomes and limited risk variable voluntary data
following elective primary THA/TKA are included in Sec. 512.13(b)(2)
and discussed in detail in section III.E.4.c.(2)(viii) of this proposed
rule. We seek comment on our proposals for determining successful
submission of voluntary data for each SHFFT model performance year.
e. Calculation of the EPM-Specific Composite Quality Score
(1) AMI Model Composite Quality Score
We propose to assign each participant an AMI model composite
quality score, calculated as the sum of the individual quality measure
performance scores
[[Page 50884]]
(including successful submission of Hybrid AMI Mortality (NQF #2473)
measure voluntary data if applicable) and improvement scores. The
quality measure performance scores would be set to reflect the intended
weights for each of the quality measures and the successful submission
of the Hybrid AMI Mortality (NQF #2473) voluntary data in the AMI model
composite quality score. Each quality measure performance would be
assigned a weight in the AMI model composite quality score, and
possible scores for the measures would be set to reflect those weights.
We would weight AMI model participant performance on each of the three
required measures and successful submission of Hybrid AMI Mortality
(NQF #2473) voluntary data according to the measure weights displayed
in Table 14.
Table 14--Measures and Associated Performance Weights in AMI Model
Composite Quality Score
------------------------------------------------------------------------
Weight in
Quality measure composite Quality domain/
quality score weight
------------------------------------------------------------------------
MORT[dash]30[dash]AMI (NQF #0230) 50% Outcome/80%.
AMI Excess Days.................. 20%
Hybrid AMI Mortality (NQF #2473) 10%
Voluntary Data.
HCAHPS Survey (NQF #0166)........ 20% Patient Experience/
20%.
------------------------------------------------------------------------
We would assign the lowest weight of 10 percent to the submission
of Hybrid AMI Mortality (NQF #2473) measure voluntary data because
these data represent an AMI model participant's meaningful
participation in advancing the quality measurement of AMI outcomes in
keeping with our goal to move toward the use of electronic health
records (EHRs) for measures, and in response to stakeholder feedback to
include clinical data in outcome measures. Given the importance of AMI
mortality as an extremely serious AMI outcome, we propose to assign the
highest individual measure weight of 50 percent to the MORT-30-AMI (NQF
#0230) measure. We propose to assign another 20 percent of the weight
to the AMI Excess Days measure that is also included in the outcome
quality domain. The remaining 20 percent of the AMI model composite
quality score weight would be assigned to the HCAHPS Survey (NQF #0166)
measure because we believe that incorporating this quality measure,
which reflects performance regarding patients' perspectives on care,
including communication, care transitions, and discharge information,
is a meaningful patient experience measure of AMI model episode
quality. This proposal of weights for the outcome and patient
experience quality domains for the AMI model composite quality score is
similar to the proposal of weights for the CABG model composite quality
score described later in this section. We would assign the highest
overall weight to the outcome quality domain (consisting of two
measures and voluntary data submission) because the measures in this
quality domain are specific to meaningful outcomes for AMI model
beneficiaries. We do not propose to assign the HCAHPS survey (NQF
#0166) measure the highest weight of the quality and patient experience
domains, as the measure is not specific to AMI model episodes, but
rather to all clinical conditions treated by AMI model participants.
Unlike the CJR model where the quality measure weights in the CJR model
composite quality score relatively evenly balance the outcome and
patient experience quality domains, we would assign the highest weight
in the AMI model to the outcome quality domain (consisting of two
measures and voluntary data submission) because the measures in this
quality domain are specific to meaningful, serious outcomes for AMI
model beneficiaries, especially mortality which is not an outcome
measure used in the CJR model composite quality score (80 FR 73375).
Under such an approach, we would first score individually each AMI
model participant on the MORT-30-AMI (NQF #0230) measure; AMI Excess
Days measure; and HCAHPS Survey (NQF #0166) measure based on the AMI
model participant's performance percentile as compared to the national
distribution of subsection (d) hospitals that are eligible for payment
under the IPPS measure performance, assigning scores according to the
point values displayed in Table 15. These individual measure scores
have been set to reflect the measure weights included in Table 14 so
they can ultimately be summed without adjustment in calculating the AMI
model composite quality score. We note that in a chained anchor
hospitalization where we propose in section III.C.4.a.(5) of this
proposed rule that once an AMI model episode is initiated at a
participant hospital, the AMI model episode would continue under the
responsibility of that participant hospital, the transfer hospital's
quality measure performance would not be included in assessing the AMI
model participant's measure performance for the AMI model composite
quality score. However, because the MORT-30-AMI (NQF #0230) measure
attributes deaths to the initial hospital that admitted the beneficiary
as an inpatient for AMI treatment in a transfer scenario, AMI model
beneficiaries who die following treatment at a transfer hospital would
be included in the AMI model participant's measure result and,
therefore, their care represented in this quality measure.
Table 15--Individual Measure Performance Scoring for Three Required AMI Quality Measures
----------------------------------------------------------------------------------------------------------------
MORT-30-AMI AMI excess HCAHPS survey
Performance percentile (points) days (points) (points)
----------------------------------------------------------------------------------------------------------------
>=90\th\........................................................ 10.00 4.00 4.00
>=80\th\ and <90\th\............................................ 9.25 3.70 3.70
>=70\th\ and <80\th\............................................ 8.50 3.40 3.40
>=60\th\ and <70\th\............................................ 7.75 3.10 3.10
>=50\th\ and <60\th\............................................ 7.00 2.80 2.80
>=40\th\ and <50\th\............................................ 6.25 2.50 2.50
[[Page 50885]]
>=30\th\ and <40\th\............................................ 5.50 2.20 2.20
<30\th\......................................................... 0.00 0.00 0.00
----------------------------------------------------------------------------------------------------------------
Given the current national distribution of subsection (d) hospitals
eligible for payment under the IPPS performance on these measures, we
believe that small point increments related to higher measure
performance deciles would be the most appropriate way to assign more
points to reflect meaningfully higher quality performance on the
measures. The absolute differences for each decile among the three
measures reflect the intended weight of the measure in the AMI model
composite quality score. These three measures are well-established
measures in use under CMS hospital programs, so we do not believe that
scores below the 30th percentile reflect quality performance such that
they should be assigned any individual quality measure score points
under the AMI model.
Additionally, we would assign a measure quality score of 2 points
for AMI model participants that successfully submit Hybrid AMI
Mortality (NQF #2473) measure voluntary data and 0 points for
participants that do not successfully submit these data. Because we
would not use the actual Hybrid AMI Mortality (NQF #2473) measure
result as an outcome measure in assessing AMI episode quality
performance under the AMI model, we propose this straightforward binary
approach to scoring the submission of Hybrid AMI Mortality (NQF #2473)
measure voluntary data for hybrid outcome measure testing.
CMS may, in future regulations, require hospitals to report
additional data elements from EHRs and propose additional hybrid
measures in this and other models and programs, such as the HIQR
Program. If, in future regulations, hospitals are required to report
these same five data elements (age; heart rate; systolic blood
pressure; troponin, creatinine) and six linking variables (CMS
Certification Number (CCN), Medicare Health Insurance Claim (HIC)
Number, date of birth, sex, admission date, and discharge date) that
are included in the Hybrid AMI Mortality (NQF #2473) measure to support
measurement through another CMS program, such as the HIQR Program, CMS
may propose changes to the AMI model measures and the methodology for
assigning the AMI model composite quality score.
Finally, we would award improvement scores on a measure-by-measure
basis to those AMI model participants that demonstrate improvement on
the measure; improvement points would be awarded for up to 10 percent
of the maximum measure performance points available, with the total AMI
model composite quality score capped at 20. Thus, improvement scores
would be up to 1.0 points for the MORT-30-AMI (NQF #0230) measure; up
to 0.4 points for the AMI Excess Days measure; and up to 0.4 points for
the HCAHPS Survey (NQF #0166) measure.
We would sum the performance and improvement scores on the three
quality measures and the score on successful submission of Hybrid AMI
Mortality (NQF #2473) measure voluntary data to calculate an AMI
composite quality score for each AMI model participant.
The proposal for the methodology to calculate the AMI model
composite quality score is included in Sec. 512.315(b)(1)-(4). We seek
comment on our proposed methodology to calculate the AMI model
composite quality score.
(2) CABG Model Composite Quality Score
We propose to assign each participant a CABG model composite
quality score, calculated as the sum of the individual quality measure
performance and improvement scores. The quality measure performance
scores would be set to reflect the intended weights for each of the
quality measures. Each quality measure performance would be assigned a
weight in the CABG model composite quality score and possible scores
for the measures would be set to reflect those weights. We would weight
CABG model participant performance on each of the two required measures
according to the measure weights displayed in Table 16.
TABLE 16--Measures and Associated Performance Weights in CABG Model
Composite Quality Score
------------------------------------------------------------------------
Weight in
Quality measure composite Quality domain/
quality score weight
------------------------------------------------------------------------
MORT-30-CABG (NQF #2558).......... 75% Outcome/75%.
HCAHPS Survey (NQF #0166)......... 25% Patient Experience/
25%.
------------------------------------------------------------------------
We propose to assign 75 percent of the weight in the CABG model
composite quality score to the outcome quality domain, assigning all
weight to the MORT-30-CABG (NQF #2558) measure, and the remaining 25
percent of the CABG model composite quality score weight to the HCAHPS
Survey (NQF #0166) measure representing the patient experience quality
domain. This proposal of weights for the outcome and patient experience
quality domains for the CABG model composite quality score is similar
to the proposal of weights for the AMI model composite quality score
described previously in this section. CABG mortality is an extremely
serious outcome and, like our proposal for the Mort-30-AMI (NQF #230)
measure in the AMI model composite quality score, we propose that the
MORT-30-CABG (NQF #2558) measure would have the highest individual
measure weight in the CABG model composite quality score. We would
assign 25 percent of the weight to the HCAHPS survey measure (NQF
#0166) because we believe that incorporating this quality measure,
which reflects performance regarding patients' perspectives on care,
including communication, care transitions, and discharge information,
is a meaningful
[[Page 50886]]
patient experience measure of CABG model episode quality. We would
assign the highest overall weight to the outcome quality domain
(consisting of one measure) because it is specific to meaningful
outcomes for CABG surgery for CABG model beneficiaries. We do not
propose to assign the HCAHPS survey (NQF #0166) measure the highest
weight of the quality and patient experience quality domains, as the
measure is not specific to CABG model episodes, but rather to all
clinical conditions treated by CABG model participants. Unlike the CJR
model where the measure weights in the CJR model composite quality
score relatively evenly balance the outcome and patient experience
quality domains, CABG mortality representing the outcome quality domain
is a serious outcome specific to CABG model beneficiaries such that we
believe it deserves a high weight in the proposed CABG model composite
quality score (80 FR 73375).
Under such an approach, we would first score individually each CABG
model participant on the MORT-30-CABG (NQF #2558) measure; and HCAHPS
Survey (NQF #0166) measure based on the participant's performance
percentile as compared to the national distribution of subsection (d)
hospitals that are eligible for payment under the IPPS measure
performance, assigning scores according to the point values displayed
in Table 17. These individual measure scores have been set to reflect
the measure weights included in Table 16 so they can ultimately be
summed without adjustment in calculating the CABG model composite
quality score.
Table 17--Individual Scoring for Two Required CABG Quality Measures
------------------------------------------------------------------------
MORT-30-CABG HCAHPS survey
Performance percentile (points) (points)
------------------------------------------------------------------------
>=90th............................ 15.00 5.00
>=80th and <90th.................. 13.88 4.63
>=70th and <80th.................. 12.75 4.25
>=60th and <70th.................. 11.63 3.88
>=50th and <60th.................. 10.50 3.50
>=40th and <50th.................. 9.38 3.13
>=30th and <40th.................. 8.25 2.75
<30th............................. 0.00 0.00
------------------------------------------------------------------------
Given the current national distribution of subsection (d) hospitals
that are eligible for payment under the IPPS performance on these
measures, we believe that small point increments related to higher
measure performance deciles would be the most appropriate way to assign
more points to reflect meaningfully higher quality performance on the
measures. The absolute differences for each decile among the two
measures reflect the intended weight of the measure in the CABG model
composite quality score. These two measures are well-established
measures in use under CMS hospital programs, so we do not believe that
scores below the 30th percentile reflect quality performance such that
they should be assigned any individual quality measure score points
under the CABG model.
Finally, we would award improvement scores on a measure-by-measure
basis to those CABG model participants that demonstrate improvement on
the measure; improvement points would be awarded for up to 10 percent
of the maximum measure performance points available, with the total
CABG model composite quality score capped at 20. Thus, improvement
scores would be up to 1.5 points for the MORT-30-CABG (NQF #2558)
measure; and up to 0.5 points for the HCAHPS Survey (NQF #0166)
measure.
We would sum the performance and improvement scores on the two
quality measures to calculate a CABG model composite quality score for
each CABG model participant.
The proposal for the methodology to calculate the CABG model
composite quality score is included in Sec. 512.315(c)(1) through (4).
We seek comment on our proposed methodology to calculate the CABG model
composite quality score.
(3) SHFFT Model Composite Quality Score
We propose to adopt the same calculation of the SHFFT model
composite quality score as the CJR model, including the proposed
changes to the CJR model composite quality score methodology described
in section V.E. of this proposed rule. For those participants in both
SHFFT and CJR models, the SHFFT model composite quality score
calculated each year would be the same as the CJR model composite
quality score (80 73370 through 73381). We propose to assign each SHFFT
model participant a SHFFT model composite quality score, capped at 20
points and calculated as the sum of the individual quality measure and
improvement scores as well as successful submission of THA/TKA
voluntary PRO and limited risk variable data if applicable. The quality
measure performance scores would be set to reflect the intended weights
for each of the quality measures. Each quality measure performance
would be assigned a weight in the SHFFT model composite quality score
and possible scores for the measures would be set to reflect those
weights. We would weight SHFFT model participant performance on each of
the two required measures and successful submission of THA/TKA
voluntary PRO and limited risk variable data according to the measure
weights displayed in Table 30.
Table 18--Measures and Associated Performance Weights in SHFFT Model
Composite Quality Score
------------------------------------------------------------------------
Weight in
Quality measure composite quality Quality domain/
score weight
------------------------------------------------------------------------
Hip/Knee Complications (NQF 50% Outcome/50%.
#1550.
THA/TKA voluntary PRO and 10% Patient Experience/
limited risk variable 50%.
submission.
HCAHPS Survey (NQF #0166)...... 40%
------------------------------------------------------------------------
[[Page 50887]]
Consistent with the CJR model, we propose to assign 50 percent of
the weight in the SHFFT model composite quality score to the outcome
quality domain, assigning 50 percent of the weight to the Hip/Knee
Complications (NQF #1550) measure. We propose to assign 50 percent of
the weight to the patient experience quality domain, specifically 10
percent of the weight in that quality domain to the THA/TKA voluntary
PRO and limited risk variable submission. We would assign 40 percent of
the weight to the HCAHPS survey measure (NQF #0166) representing the
patient experience (80 FR 73375). We would assign 40 percent to the
HCAHPS survey measure (NQF #0166) because we believe that incorporating
this quality measure, which reflects performance regarding patients'
perspectives on care, including communication, care transitions, and
discharge information, is a highly meaningful outcome measure of SHFFT
episode quality under the SHFFT model, and because doing so ensures
that there is a consistent methodology for linking quality performance
and improvement to payment for SHFFT model participants that are also
participating in the CJR model. As in the CJR model, we believe this
weighting appropriately balances patient experience with meaningful
health outcomes for beneficiaries (80 FR 73375).
Under such an approach, we would first score individually each
SHFFT model participant on the Hip/Knee Complications (NQF #1550)
measure; and HCAHPS Survey (NQF #0166) measure based on the
participant's performance percentile as compared to the national
distribution of subsection (d) hospitals that are eligible for payment
under the IPPS measure performance, assigning scores according to the
point values displayed in Table 19. These individual measure scores
have been set to reflect the measure weights included in Table D6 so
they can ultimately be summed without adjustment in calculating the
SHFFT model composite quality score. We note that the point score for
each decile for the two measures for the SHFFT model is the same as
that used for other CJR model.
Table 19--Individual Scoring for Two Required SHFFT Quality Measures
------------------------------------------------------------------------
Hip/knee HCAHPS survey
Performance percentile complications quality score
(points) (points)
------------------------------------------------------------------------
>=90th............................ 10.00 8.00
>=80th and <90th.................. 9.25 7.40
>=70th and <80th.................. 8.50 6.80
>=60th and <70th.................. 7.75 6.20
>=50th and <60th.................. 7.00 5.60
>=40th and <50th.................. 6.25 5.00
>=30th and <40th.................. 5.50 4.40
<30th............................. 0.00 0.00
------------------------------------------------------------------------
Given the current national distribution of subsection (d) hospitals
that are eligible for payment under the IPPS performance on these
measures, we believe that small point increments related to higher
measure performance deciles would be the most appropriate way to assign
more points to reflect meaningfully higher quality performance on the
measures. The absolute differences for each decile among the three
measures reflect the intended weight of the measure in the SHFFT model
composite quality score. These two measures are well-established
measures in use under CMS hospital programs, so we do not believe that
scores below the 30th percentile reflect quality performance such that
they should be assigned any individual quality measure score points
under the SHFFT model.
As in the CJR model, we propose to assign a measure quality score
of 2 points for SHFFT model participants that successfully submit THA/
TKA voluntary PRO and limited risk variable data and 0 points for
participants that do not successfully submit these data (80 FR 73376).
Finally, we would award improvement scores on a measure-by-measure
basis to those SHFFT model participants that demonstrate improvement on
the measure (defined as year-over-year improvement of 2 or more deciles
in the performance distribution); improvement points would be awarded
for up to 10 percent of the maximum measure performance points
available, with the total SHFFT model composite quality score capped at
20. Thus, improvement scores would be up to 1.0 points for the Hip/Knee
Complications (NQF #1550) measure; and up to 0.8 points for the HCAHPS
Survey (NQF #0166) measure.
We would sum the performance and improvement scores on the two
required quality measures and the score on successful submission of
THA/TKA voluntary PRO and limited risk variable data to calculate a
SHFFT model composite quality score for each SHFFT model participant.
For those CJR model participants (the majority of SHFFT model
participants), the SHFFT model composite quality score would be the
same as the participant's score for the CJR model.
The proposal for the methodology to calculate the SHFFT model
composite quality score is included in Sec. 512.315(d)(1) through (4).
We seek comment on our proposed methodology to calculate the SHFFT
model composite quality score.
f. EPM Pay-for-Performance Methodologies To Link Quality and Payment
(1) Overview of Pay-for-Performance Proposals Applicable to the EPMs
As in the CJR model, we propose that the maximum effective discount
factor for all EPM participants that could be incorporated in quality-
adjusted target prices would be 3.0 percent (80 FR 733760). We refer to
section III.D.4.b.(10) of this proposed rule for further discussion of
the application of the effective discount factor to EPM-episode
benchmark prices in calculating quality-adjusted target prices. EPM
participants that provide high-quality episode care would have the
opportunity to reduce the effective discount factor used to calculate
their quality-adjusted prices at reconciliation. The effective discount
factors are displayed in tables in the following EPM-specific sections,
based on the EPM-specific composite quality score that would place each
EPM participant into one of four quality categories, specifically
``Below Acceptable,'' ``Acceptable,'' ``Good,'' and ``Excellent,'' for
each EPM performance year. Three tables are required to display the
proposed effective discount factor and applicable discount factor (the
discount
[[Page 50888]]
factor that represents the phase-in of repayment responsibility in
performance years 2 (DR) and 3) for each quality category due to the
phase-in of EPM participant repayment responsibility from no
responsibility in performance year 1 and performance year 2 (NDR), to
partial responsibility in performance years 2 (DR) and 3, and finally
full responsibility in performance years 4 and 5 as discussed in
section III.D.2.c. Note that the applicable discount factor only
applies to EPM performance years 2 (DR) and 3.
(2) AMI and CABG Model Pay-for-Performance Methodologies
(a) AMI Model Pay-for-Performance Methodology
We propose to incorporate the AMI model composite quality score in
the AMI model payment methodology by (1) requiring a minimum AMI model
composite quality score for reconciliation payment eligibility if the
AMI model participant's actual episode payments are less than the
quality-adjusted target price and (2) determining the effective
discount factor included in the quality-adjusted target price
experienced by the AMI model participant in the reconciliation process.
The payment policies we would apply are displayed in Tables 20, 21, and
22 for the performance years of the AMI model. Under the AMI model as
proposed, there is no AMI model participant repayment responsibility in
performance year 1 and performance year 2 (NDR) and this responsibility
begins to be phased-in in performance year 2 (DR), with full
implementation in performance year 4. Because repayment responsibility
is phased-in, in performance years 2 (DR) and 3, repayment
responsibility only applies to a portion of the amount of excess AMI
model episode spending that results from the quality-adjusted target
prices that include the AMI model participant's effective discount
factor. We, therefore, refer in the repayment column to the applicable
discount factor for repayment amount in performance years 2 (DR) and 3.
The effective discount factor applies to both the reconciliation
payment and the repayment amount in performance years 4 and 5. We note
that the average Medicare payment for historical AMI episodes beginning
in CYs 2012 to 2014 was $24,200.\70\
---------------------------------------------------------------------------
\70\ Episodes for AMI beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that began in CYs 2012-2014.
Table 20--Performance Year 1 and Performance Year 2 (NDR): Relationship of AMI Model Composite Quality Score to
Reconciliation Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective
discount
AMI model composite quality score Eligible for factor for Effective discount factor
reconciliation payment reconciliation for repayment amount
payment %
----------------------------------------------------------------------------------------------------------------
<3.6.................................. No......................... 3.0 Not applicable,
>=3.6 and <6.9........................ Yes........................ 3.0 Not applicable.
>=6.9 and <=14.8...................... Yes........................ 2.0 Not applicable.
>14.8................................. Yes........................ 1.5 Not applicable.
----------------------------------------------------------------------------------------------------------------
Table 21--Performance Years 2 (DR) and 3: Relationship of AMI Model Composite Quality Score to Reconciliation
Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Applicable
discount discount
AMI model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment % amount* %
----------------------------------------------------------------------------------------------------------------
<3.6........................................ No................................ 3.0 2.0
>=3.6 and <6.9.............................. Yes............................... 3.0 2.0
>=6.9 and <=14.8............................ Yes............................... 2.0 1.0
>14.8....................................... Yes............................... 1.5 0.5
----------------------------------------------------------------------------------------------------------------
* The applicable discount factor for the repayment amount only applies in performance years 2 (DR) and 3 when
repayment responsibility is being phased-in.
Table 22--Performance Years 4 and 5: Relationship of AMI Model Composite Quality Score to Reconciliation Payment
Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Effective
discount discount
AMI model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment amount
----------------------------------------------------------------------------------------------------------------
<3.6........................................ No................................ 3.0 3.0
>=3.6 and <6.9.............................. Yes............................... 3.0 3.0
>=6.9 and <=14.8............................ Yes............................... 2.0 2.0
>14.8....................................... Yes............................... 1.5 1.5
----------------------------------------------------------------------------------------------------------------
[[Page 50889]]
Under this approach, the maximum AMI model effective discount
factor included in the quality-adjusted target price would be 3.0
percent, consistent with the CJR model (80 FR 73365). We believe that a
maximum effective discount factor of 3.0 percent is reasonable as it is
within the range of discount percentages included in the ACE
demonstration and it is the Model 2 BPCI discount factor for 30- and
60-day episodes, where BPCI participants are testing AMI episodes
subject to the 3.0 percent discount factor. AMI model participants that
provide high quality episode care would have the opportunity for a
lower effective discount factor to be included in their quality-
adjusted target prices at reconciliation as displayed in Tables 20, 21,
and 22.
Under this methodology, we would require AMI model participants to
achieve a minimum AMI model composite quality score of >=3.6 to be
eligible for a reconciliation payment if actual episode payments were
less than the quality-adjusted target price based on the 3.0 percent
maximum effective discount factor. Participants with below acceptable
quality performance reflected in an AMI model composite quality score
<3.6 would not be eligible for a reconciliation payment if actual AMI
model episode payments were less than the quality-adjusted target
price. A level of quality performance that is below acceptable would
not affect AMI model participants' repayment responsibility if actual
AMI model episode payments exceed the quality-adjusted target price. We
believe that excessive reductions in utilization that lead to low
actual AMI model episode payments and that could result from the
financial incentives of an EPM would be limited by a requirement that
this minimum level of AMI model episode quality be achieved for
reconciliation payments to be made. This policy would encourage AMI
model participants to focus on appropriate reductions or changes in
utilization to achieve high quality care in a more efficient manner.
Therefore, these participants would be ineligible to receive a
reconciliation payment if actual AMI model episode payments were less
than the quality-adjusted target price.
AMI model participants with an acceptable AMI model composite
quality score of >=3.6 and <6.9 would be eligible for a reconciliation
payment if actual AMI model episode payments were less than the
quality-adjusted target price based on a 3.0 percent effective discount
factor because their quality performance was at the acceptable level
established for the AMI model. Therefore, these AMI model participants
would be eligible to receive a reconciliation payment if actual AMI
model episode payments were less than the quality-adjusted target
price.
AMI model participants with a good AMI model composite quality
score of >=6.9 and <=14.8 would be eligible for a reconciliation
payment if actual AMI model episode payments were less than the
quality-adjusted target price based on a 2.0 percent effective discount
factor that reflects their good quality performance. Thus, participants
achieving this level of quality for AMI episodes under the AMI model
would either have less repayment responsibility (that is, the reduced
effective discount factor would offset a portion of their repayment
responsibility) or receive a higher reconciliation payment (that is,
the reduced effective discount factor would increase the reconciliation
payment) at reconciliation than they would have otherwise based on a
comparison of actual AMI model episode payments to quality-adjusted
target prices that include the maximum 3.0 percent effective discount
factor.
Finally, AMI model participants with an excellent AMI model
composite score quality score of >=14.8 would be eligible to receive a
reconciliation payment if actual AMI model episode payments were less
than the quality-adjusted target price based on a 1.5 percent effective
discount factor that reflects their excellent performance. Thus,
participants achieving this level of quality for AMI episodes under the
AMI model would either have less repayment responsibility (that is, the
reduced effective discount factor would offset a portion of their
repayment responsibility) or receive a higher reconciliation payment
(that is, the reduced effective discount factor would increase the
reconciliation payment) at reconciliation than they would have
otherwise based on a comparison of actual AMI model episode payments to
quality-adjusted target prices that include the maximum 3.0 percent
effective discount factor.
Under this methodology, the proposed stop-loss and stop-gain limits
discussed in section III.D.7.b. of this proposed rule would not change.
We believe this approach to quality incentive payments based on the AMI
model composite quality score could have the effect of increasing the
alignment of the financial and quality performance incentives under the
AMI model to the potential benefit of AMI model participants and their
collaborators as well as CMS, and would be consistent with the CJR
model methodology linking quality and payment.
The proposal to link quality to payment in the AMI model pay-for-
performance methodology is included in Sec. 512.315(b)(5). We seek
comment on our proposal to link quality to payment in the AMI model
pay-for-performance methodology.
(b) CABG Model Pay-for-Performance Methodology
We propose to incorporate the CABG model composite quality score in
the CABG model payment methodology by--(1) requiring a minimum CABG
model composite quality score for reconciliation payment eligibility if
the CABG model participant's actual episode payments are less than the
quality-adjusted target price; and (2) determining the effective
discount factor included in the quality-adjusted target price
experienced by the CABG model participant in the reconciliation
process. The payment policies we would apply are displayed in Tables
23, 24, and 25 for the performance years of the CABG model. Under the
CABG model as proposed, there is no CABG model participant repayment
responsibility in performance year 1 and performance year 2 (NDR) and
this responsibility begins to be phased-in in performance year 2 (DR),
with full implementation in performance year 4. Because repayment
responsibility is phased-in, in performance years 2 (DR) and 3,
repayment responsibility only applies to a portion of the amount of
excess CABG model episode spending that results from the quality-
adjusted target prices that include the CABG model participant's
effective discount factor. We, therefore, refer in the repayment column
to the applicable discount factor for repayment amount in performance
years 2 (DR) and 3. The effective discount factor applies to both the
reconciliation payment and the repayment amount in performance years 4
and 5. We note that the average Medicare payment for historical CABG
episodes beginning in CYs 2012 to 2014 was $47,000.\71\
---------------------------------------------------------------------------
\71\ Episodes for CABG beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that began in CYs 2012-2014.
[[Page 50890]]
Table 23--Performance Year 1 and Performance Year 2 (NDR): Relationship of CABG Model Composite Quality Score to
Reconciliation Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Effective
discount discount
CABG model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment % amount %
----------------------------------------------------------------------------------------------------------------
<2.8........................................ No................................ 3.0 Not
applicable.
>=2.8 and <4.8.............................. Yes............................... 3.0 Not
applicable.
>=4.8 and <=17.5............................ Yes............................... 2.0 Not
applicable.
>17.5....................................... Yes............................... 1.5 Not
applicable.
----------------------------------------------------------------------------------------------------------------
Table 24--Performance Years 2 (DR) and 3: Relationship of CABG Model Composite Quality Score to Reconciliation
Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Applicable
discount discount
CABG model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment % amount * %
----------------------------------------------------------------------------------------------------------------
<2.8........................................ No................................ 3.0 2.0
>=2.8 and <4.8.............................. Yes............................... 3.0 2.0
>=4.8 and <=17.5............................ Yes............................... 2.0 1.0
>17.5....................................... Yes............................... 1.5 0.5
----------------------------------------------------------------------------------------------------------------
* The applicable discount factor for the repayment amount only applies in performance years (DR) and 3 when
repayment responsibility is being phased-in.
Table 25--Performance Years 4 and 5: Relationship of CABG Model Composite Quality Score to Reconciliation
Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Effective
discount discount
CABG model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment % amount %
----------------------------------------------------------------------------------------------------------------
<2.8........................................ No................................ 3.0 3.0
>=2.8 and <4.8.............................. Yes............................... 3.0 3.0
>=4.8 and <=17.5............................ Yes............................... 2.0 2.0
>17.5....................................... Yes............................... 1.5 1.5
----------------------------------------------------------------------------------------------------------------
Under this approach, the maximum CABG model effective discount
factor included in the quality-adjusted target price would be 3.0
percent, consistent with the CJR model (80 FR 73365). We believe that a
maximum effective discount factor of 3.0 percent is reasonable as it is
within the range of discount percentages included in the Medicare Acute
Care Episode (ACE) demonstration and it is the Model 2 BPCI discount
factor for 30 and 60 day episodes, where BPCI participants are testing
CABG episodes subject to the 3.0 percent discount factor. CABG model
participants that provide high quality episode care would have the
opportunity for a lower effective discount factor to be included in
their quality-adjusted target prices at reconciliation as displayed in
Tables 23, 24, and 25.
Under this methodology, we would require CABG model participants to
achieve a minimum CABG model composite quality score of >=2.8 to be
eligible for a reconciliation payment if actual episode payments were
less than the quality-adjusted target price based on the 3.0 percent
maximum effective discount factor. Participants with below acceptable
quality performance reflected in an CABG model composite quality score
<2.8 would not be eligible for a reconciliation payment if actual CABG
model episode payments were less than the quality-adjusted target
price. A level of quality performance that is below acceptable would
not affect participants' repayment responsibility if actual CABG model
episode payments exceed the quality-adjusted target price. We believe
that excessive reductions in utilization that lead to low actual CABG
model episode payments and that could result from the financial
incentives of an EPM would be limited by a requirement that this
minimum level of CABG model episode quality be achieved for
reconciliation payments to be made. This policy would encourage CABG
model participants to focus on appropriate reductions or changes in
utilization to achieve high quality care in a more efficient manner.
Therefore, these participants would be ineligible to receive a
reconciliation payment if actual CABG model episode payments were less
than the quality-adjusted target price.
CABG model participants with an acceptable CABG model composite
quality score of >=2.8 and <4.8 would be eligible for a reconciliation
payment if actual CABG model episode payments were less than the
quality-adjusted target price based on a 3.0 percent effective discount
factor because their quality performance was at the acceptable level
established for the CABG model. Therefore, these CABG model
participants would be eligible to
[[Page 50891]]
receive a reconciliation payment if actual CABG model episode payments
were less than the quality-adjusted target price.
CABG model participants with a good CABG model composite quality
score >=4.8 and <=17.5 would be eligible for a reconciliation payment
if actual CABG model episode payments were less than the quality-
adjusted target price based on a 2.0 percent effective discount factor
that reflects their good quality performance. Thus, participants
achieving this level of quality for CABG episodes under the CABG model
would either have less repayment responsibility (that is, the reduced
effective discount factor would offset a portion of their repayment
responsibility) or receive a higher reconciliation payment (that is,
the reduced effective discount factor would increase the reconciliation
payment) at reconciliation than they would have otherwise based on a
comparison of actual CABG model episode payments to quality-adjusted
target prices that include the maximum 3.0 percent effective discount
factor.
Finally, CABG model participants with an excellent CABG model
composite score quality score of >17.5 would be eligible to receive a
reconciliation payment if actual CABG model episode payments were less
than the quality-adjusted target price based on a 1.5 percent effective
discount factor that reflects their excellent performance. Thus,
participants achieving this level of quality for CABG model episodes
would either have less repayment responsibility (that is, the reduced
effective discount factor would offset a portion of their repayment
responsibility) or receive a higher reconciliation payment (that is,
the reduced effective discount factor would increase the reconciliation
payment) at reconciliation than they would have otherwise based on a
comparison of actual CABG model episode payments to quality-adjusted
target prices that include the maximum 3.0 percent effective discount
factor.
Under this methodology, the proposed stop-loss and stop-gain limits
discussed in section III.D.7.b. of this proposed rule would not change.
We believe this approach to quality incentive payments based on the
CABG model composite quality score could have the effect of increasing
the alignment of the financial and quality performance incentives under
the CABG model to the potential benefit of CABG model participants and
their collaborators as well as CMS, and would be consistent with the
CJR model methodology linking quality and payment.
The proposal to link quality to payment in the CABG model pay-for-
performance methodology is included in Sec. 512.315(c)(5). We seek
comment on our proposal to link quality to payment in the CABG model
pay-for-performance methodology.
(c) Alignment Between the AMI and CABG Model Methodologies
The AMI and CABG models are closely related, given that they both
are based on a significant event or procedure for a beneficiary with
CAD. As discussed in sections III.D.2.b. and c. of this proposed rule,
we propose the use of a 30-day mortality measure in both models,
specifically MORT-30-AMI (NQF #0230) with a weight of 50 percent in the
AMI model composite quality score and MORT-30-CABG (NQF #2558) with a
weight of 75 percent in the CABG model quality score. The beneficiaries
included in the measure have some overlap, because some beneficiaries
with AMI will have a CABG during their hospitalization that begins an
episode. Analysis of both the MORT-30-AMI (NQF #0230) and MORT-30-CABG
(NQF #2558) measure national distributions suggests that improving from
the 25th percentile to 75th percentile represents roughly a 1
percentage point decrease in mortality rates for both measures.
In addition, we note that for historical episodes beginning in 2012
to 2014, the average Medicare spending for an AMI episode that extends
90 days post-hospital discharge was approximately $24,200 and for a
CABG episode was approximately $47,000.\72\ However, because we propose
the same 1.5 percent to 3.0 percent effective discount factor range
based on quality performance and improvement for the AMI and CABG
models (and, to a lesser degree, because of the modestly lower weight
assigned to the mortality measure under the AMI model), the absolute
dollar amounts tied to changes in AMI or CABG mortality rates are
different in the two models. A larger absolute financial incentive is
associated with improvement in CABG mortality than AMI mortality under
our proposal. We recognize that mortality is a serious outcome for
beneficiaries with CAD who have a significant event or procedure, and
we considered setting a wider effective discount factor range based on
quality in the AMI model than the CABG model to align the absolute
financial incentives to improve mortality under both models. For
example, to create a more similar absolute financial incentive between
the lowest and highest effective discount percentages in the AMI and
CABG models, we could set the effective discount factor range for the
AMI model at 0.75 percent to 3.75 percent and the CABG model range at
1.5 percent to 3 percent. Alternatively, we could set the AMI model
effective discount factor range at 1.5 percent to 3 percent and
compress the CABG effective discount factor range. While we do not
propose different effective discount factor ranges for the AMI and CABG
models in order to retain consistency with the CJR model and the BPCI
initiative, we seek comments about the potential benefits and drawbacks
of establishing the same absolute dollar incentive for similar
improvements in quality across different models that have similar
measures but vary in average episode cost. This feedback will be useful
as we consider future episode payment models and candidate quality
measures for potential new and existing models, as well as consider
future refinements to the pay-for-performance methodologies under the
models. Our goal in all of our episode payment models is to create
strong financial incentives for quality performance and improvement for
participants at all level of current quality performance and to
rationalize the strength of the financial incentives in the context of
the specificity and importance of the quality measures used under the
models.
---------------------------------------------------------------------------
\72\ Episodes for AMI and CABG beneficiaries initiated by all
U.S. IPPS hospitals and constructed using standardized Medicare FFS
Parts A and B claims, as proposed in this rule that began in CYs
2012-2014.
---------------------------------------------------------------------------
(3) SHFFT Model Pay-for-Performance Methodology
We propose to incorporate the SHFFT model composite quality score
in the SHFFT model payment methodology by (1) requiring a minimum SHFFT
model composite quality score for reconciliation payment eligibility if
the SHFFT model participant's actual episode payments are less than the
quality-adjusted target price and (2) determining the effective
discount factor included in the quality-adjusted target price
experienced by the SHFFT model participant in the reconciliation
process. The payment policies we would apply are displayed in Tables
26, 27, and 28 for the performance years of the SHFFT model. Under the
SHFFT model as proposed, there is no SHFFT model participant repayment
responsibility in performance year 1 and performance year 2 (NDR) and
this responsibility begins to be phased-in in performance year 2 (DR),
with full implementation in performance year 4. Because repayment
[[Page 50892]]
responsibility is phased-in, in performance years 2 (DR) and 3,
repayment responsibility only applies to a portion of the amount of
excess SHFFT model episode spending that results from the quality-
adjusted target prices that include the SHFFT model participant's
effective discount factor. We, therefore, refer in the repayment column
to the applicable discount factor for repayment amount in performance
years 2 (DR) and 3. The effective discount factor applies to both the
reconciliation payment and the repayment amount in performance years 4
and 5. We note that the average Medicare payment for historical SHFFT
episodes beginning in CYs 2012 to 2014 was $43,000.\73\
---------------------------------------------------------------------------
\73\ Episodes for SHFFT beneficiaries initiated by all U.S. IPPS
hospitals and constructed using standardized Medicare FFS Parts A
and B claims, as proposed in this rule that began in CYs 2012-2014.
---------------------------------------------------------------------------
We refer to section V.E. of this proposed rule for discussion of
the correction to the composite quality score ranges for the four
quality categories from what was presented in the CJR final rule (80 FR
73378). The SHFFT model composite quality score ranges displayed in
Tables 26 through 28 are the corrected ranges that also apply to the
CJR model.
Table 26--Performance Year 1 and Performance Year 2 (NDR): Relationship of SHFFT Model Composite Quality Score
to Reconciliation Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective
discount
SHFFT model composite quality score Eligible for factor for Effective discount factor
reconciliation payment reconciliation for repayment amount
payment %
----------------------------------------------------------------------------------------------------------------
<5.0.................................. No......................... 3.0 Not applicable.
>=5.0 and <6.9........................ Yes........................ 3.0 Not applicable.
>=6.9 and <=15.0...................... Yes........................ 2.0 Not applicable.
>15.0................................. Yes........................ 1.5 Not applicable.
----------------------------------------------------------------------------------------------------------------
Table 27--Performance Years 2 (DR) and 3: Relationship of SHFFT Model Composite Quality Score to Reconciliation
Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Applicable
Discount Discount
SHFFT Model Composite Quality Score Eligible for Reconciliation Factor for Factor for
Payment Reconciliation Repayment
Payment % Amount* %
----------------------------------------------------------------------------------------------------------------
<5.0........................................ No................................ 3.0 2.0
>=5.0 and <6.9.............................. Yes............................... 3.0 2.0
>=6.9 and <=15.0............................ Yes............................... 2.0 1.0
>15.0....................................... Yes............................... 1.5 0.5
----------------------------------------------------------------------------------------------------------------
*The applicable discount factor for the repayment amount only applies in performance years 2 (DR) and 3 when
repayment responsibility is being phased-in.
Table 28--Performance Years 4 and 5: Relationship of SHFFT Model Composite Quality Score to Reconciliation
Payment Eligibility and the Effective Discount Factor Experienced at Reconciliation
----------------------------------------------------------------------------------------------------------------
Effective Effective
discount discount
SHFFT model composite quality score Eligible for reconciliation factor for factor for
payment reconciliation repayment
payment % amount %
----------------------------------------------------------------------------------------------------------------
<5.0........................................ No................................ 3.0 3.0
>=5.0 and <6.9.............................. Yes............................... 3.0 3.0
>=6.9 and <=15.0............................ Yes............................... 2.0 2.0
>15.0....................................... Yes............................... 1.5 1.5
----------------------------------------------------------------------------------------------------------------
Under this methodology, we would require SHFFT model participants
to achieve a minimum SHFFT model composite quality score of >=5.0 to be
eligible for a reconciliation payment if actual episode payments were
less than the quality-adjusted target price based on the 3.0 percent
maximum effective discount factor. Participants with below acceptable
quality performance reflected in a SHFFT model composite quality score
<5.0 would not be eligible for a reconciliation payment if actual SHFFT
model episode payments were less than the quality-adjusted target
price. A level of quality performance that is below acceptable would
not affect participants' repayment responsibility if actual SHFFT model
episode payments exceed the quality-adjusted target price. We believe
that excessive reductions in utilization that lead to low actual SHFFT
model episode payments and that could result from the financial
incentives of an EPM would be limited by a requirement that this
minimum level of SHFFT model episode quality be achieved for
reconciliation payments to be made. This policy would encourage SHFFT
model participants to
[[Page 50893]]
focus on appropriate reductions or changes in utilization to achieve
high quality care in a more efficient manner. Therefore, these
participants would be ineligible to receive a reconciliation payment if
actual SHFFT model episode payments were less than the quality-adjusted
target price.
SHFFT model participants with an acceptable SHFFT model composite
quality score of >=5.0 and <6.9 would be eligible for a reconciliation
payment if actual SHFFT model episode payments were less than the
quality-adjusted target price based on a 3.0 percent effective discount
factor because their quality performance was at the acceptable level
established for the SHFFT model. Therefore, these SHFFT model
participants would be eligible to receive a reconciliation payment if
actual SHFFT model episode payments were less than the quality-adjusted
target price.
SHFFT model participants with a good SHFFT model composite quality
score of >=6.9 and <=15.0 would be eligible for a reconciliation
payment if actual SHFFT model episode payments were less than the
quality-adjusted target price based on a 2.0 percent effective discount
factor that reflects their good quality performance. Thus, participants
achieving this level of quality for SHFFT model episodes under the
SHFFT model would either have less repayment responsibility (that is,
the reduced effective discount factor would offset a portion of their
repayment responsibility) or receive a higher reconciliation payment
(that is, the reduced effective discount factor would increase the
reconciliation payment) at reconciliation than they would have
otherwise based on a comparison of actual SHFFT model episode payments
to quality-adjusted target prices that include the maximum 3.0 percent
effective discount factor.
Finally, SHFFT model participants with an excellent SHFFT model
composite score quality score of >15.0 would be eligible to receive a
reconciliation payment if actual SHFFT model episode spending was less
than the quality-adjusted target price based on a 1.5 percent effective
discount factor that reflects their excellent performance. Thus,
participants achieving this level of quality for SHFFT model episodes
would either have less repayment responsibility (that is, the reduced
effective discount factor would offset a portion of their repayment
responsibility) or receive a higher reconciliation payment (that is,
the reduced effective discount factor would increase the reconciliation
payment) at reconciliation than they would have otherwise based on a
comparison of actual SHFFT model episode payments to quality-adjusted
target prices that include the maximum 3.0 percent effective discount
factor.
Under this methodology, the proposed stop-loss and stop-gain limits
discussed in section III.D.7.b. of this proposed rule would not change.
We believe this approach to quality incentive payments based on the
SHFFT model composite quality score could have the effect of increasing
the alignment of the financial and quality performance incentives under
the SHFFT model to the potential benefit of SHFFT model participants
and their collaborators as well as CMS, and would be consistent with
the CJR model methodology linking quality and payment.
The proposal to link quality to payment in the SHFFT model pay-for-
performance methodology is included in Sec. 512.315(d)(5). We seek
comment on our proposal to link quality to payment in the SHFFT model
pay-for-performance methodology.
4. Details on Quality Measures for the EPMs
a. AMI Model-Specific Measures
(1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate
Following Acute Myocardial Infarction (AMI) Hospitalization (NQF #0230)
(MORT-30-AMI)
(a) Background
AMI is one of the most common principal hospital discharge
diagnoses among older adults and is associated with high mortality. AMI
was the tenth most common principal discharge diagnosis among patients
with Medicare in 2012.\74\ Each year, over 600,000 Americans will
experience an AMI. Despite improvements in treatments, 30-day mortality
rates following AMI exceed 7 percent. CMS pays approximately $11.7
billion annually for in-hospital costs for Medicare beneficiaries with
coronary heart disease, of which AMI is a major contributor. The high
prevalence and considerable morbidity and mortality associated with AMI
create an economic burden on the healthcare system.\75\
---------------------------------------------------------------------------
\74\ Agency for Healthcare Research and Quality (AHRQ).
Healthcare Cost and Utilization Project (HCUP) http://hcupnet.ahrq.gov/.
\75\ American Heart Association. Heart Disease and Stroke
Statistics--2010 Update. Dallas, Texas: American Heart Association;
2010. c2010, American Heart Association.
---------------------------------------------------------------------------
Hospital mortality is an outcome that is likely attributable to
care processes and is an important outcome for patients. Complex and
critical aspects of care, such as communication between providers,
prevention of and response to complications, patient safety, and
coordinated transitions to the outpatient environment, all contribute
to patient outcomes. Many current hospital interventions are known to
decrease the risk of death within 30 days of hospital
admission.76 77 We believe it is important to assess the
quality of care provided to Medicare beneficiaries who are hospitalized
for AMI.
---------------------------------------------------------------------------
\76\ Jha AK, Orav EJ, Li Z, Epstein AM. The inverse relationship
between mortality rates and performance in the Hospital Quality
Alliance measures. Health Aff (Millwood). 2007 Jul-Aug; 26(4):1104-
10.
\77\ Rathore SS, Curtis JP, Chen J, Wang Y, Nallamothu BK,
Epstein AJ, Krumholz HM. National Cardiovascular Data Registry.
Association of door-to-balloon time and mortality in patients
admitted to hospital with ST elevation myocardial infarction:
National cohort study. BMJ. 2009 May 19; 338:b1807.
---------------------------------------------------------------------------
The measure developed by CMS, and currently implemented in the HIQR
and HVBP Programs, assesses a hospital's risk-standardized mortality
rate, which is the rate of death after admission to a hospital with a
principal diagnosis of AMI. The measure outcome is the rate of
mortality occurring after admission with a principal diagnosis of AMI
for patients 65 and older during a 30-day period that begins with the
date of the index admission for the specific hospital. An index
admission is the hospitalization which is included in the measure
cohort because it meets all inclusion criteria and does not meet any
exclusion criteria. The index admission is the hospitalization to which
the mortality outcome is attributed. The median hospital-level risk-
standardized mortality rate for 2016 public reporting on Hospital
Compare was 14.2 percent, with a interquartile range from 13.7 percent
to 14.6 percent in hospitals. The variation in mortality rates suggests
that important differences in the quality of care delivered across
hospitals exist, and there is room for quality improvement.
We developed the measure of hospital-level risk-standardized
mortality rate (RSMR) following AMI hospitalization, which was later
endorsed by the NQF (NQF #0230). The measure has been publicly reported
on Hospital Compare since FY 2007, and was incorporated into what is
now the HIQR Program since FY 2008 (FY 2008 IPPS/LTCH final rule 71 FR
67960), and the HVBP Program since FY 2014 (FY 2011 IPPS/LTCH final
rule 76 FR 26510).
(b) Data Sources
We propose to use Medicare Part A and Part B FFS claims submitted
by the
[[Page 50894]]
AMI model participant as the data source for calculation of the MORT-
30-AMI (NQF #0230) measure. Index admission diagnoses and in-hospital
comorbidities are assessed using Medicare Part A claims. Additional
comorbidities prior to the index admission are assessed as Part A
inpatient, outpatient, and Part B office visit Medicare claims in the
12 months prior to the index (initial) admission. Enrollment and post-
discharge mortality status are obtained from Medicare's enrollment
database which contains beneficiary demographics, benefits/coverage,
and vital status information.
(c) Cohort
The MORT-30-AMI (NQF #0230) measure includes Medicare FFS
beneficiaries, aged 65 years or older, discharged from non-federal
acute care hospitals with a principal discharge diagnosis of AMI and
with a complete claims history for the 12 months prior to admission.
Eligible hospitalizations are defined using the following ICD-10-CM
codes: I2109, I2119, I2111, I2119, I2129, I214, and I213.
We propose that the measure will include index admissions to all
non-federal acute care hospitals, which includes all AMI model
participants. Hospital performance will only be publically reported for
hospitals with 25 or more index admissions in the 3-year measurement
period. The AMI model cohort would differ from the hospital cohort that
is currently captured in the measure through the HIQR Program. Although
performance on the measure will not be publically reported for
hospitals with fewer than 25 cases, they will receive information about
their performance. We refer readers to section III.B.5. of this
proposed rule for participant selection for the AMI model. For eligible
hospitalizations defined using ICD-9-CM codes, we refer readers to the
CMS Web site at: http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
(d) Inclusion and Exclusion Criteria
We propose that an index admission is the hospitalization to which
the mortality outcome is attributed. We note that for purposes of the
EPMs where we need to identify episodes that are included in the EPMs,
we use the terms anchor and chained anchor hospitalization to identify
hospitalizations that initiate EPM episodes for beneficiaries whose
care is included in the EPMs. In describing the quality measures
themselves in detail in section III.E.4. of this proposed rule, we use
the term index hospitalization to identify hospitalizations of
beneficiaries whose outcomes are included in the measures. Thus, anchor
hospitalizations and index hospitalizations would have varying degrees
of overlap depending on the specific quality measure. The measure
includes the following index admissions for patients:
Having a principal discharge diagnosis of AMI.
Enrolled in Medicare FFS.
Aged 65 or over.
Not transferred from another acute care facility.
Enrolled in Medicare Part A and Part B for the 12 months
prior to the date of index admission, and enrolled in Part A during the
index admission.
This measure excludes the following index admissions for patients:
Discharged alive on the day of admission or the following
day who were not transferred to another acute care facility.
With inconsistent or unknown vital status or other
unreliable demographic (age and gender) data;
Enrolled in the Medicare hospice program any time in the
12 months prior to the index admission, including the first day of the
index admission;
Discharged against medical advice American Medical
Association (AMA); or
Without at least 30 days of post-discharge enrollment in
FFS Medicare as the 30-day mortality outcome cannot be assessed for
these patients.
Finally, for the purpose of this measure, admissions within 30 days
of discharge from an index admission are not eligible to also be index
admissions. Thus, only one index admission for AMI per beneficiary is
randomly selected for inclusion in the cohort.
(e) Risk-Adjustment
We note that this measure is aligned with the risk-adjustment
methodologies adopted for the MORT-30-AMI (NQF #0230) measure under the
HIQR Program in accordance with section 1886(b)(3)(B)(viii)(VIII) of
the Act, as finalized in FY 2008 IPPS/LTCH final rule (2008 IPPS/LTCH
final rule 71 FR 67960). We also note that the measure risk adjustment
takes into account patient age, sex, and comorbidities to allow a fair
assessment of hospital performance. The measure defines the patient
risk factors for mortality using diagnosis codes collected from all
patient claims 1 year prior to patient index hospitalization for AMI.
As previously noted in the MORT-30-AMI measure (NQF #0230), ICD-10-CM
codes on Medicare Parts A and B administrative claims are used to
inform the risk prediction for each patient; diagnostic codes from
post-acute care settings are included in the measure, but this
information is only used to identify a hospital's patient case mix in
order to adequately adjust for differences in case mix across
hospitals. Use of Parts A and B data does not mean the measure is
applicable to post-acute care settings, only that it uses comprehensive
data to predict the risk of the outcome and adjust for hospital patient
case mix. We note that the patient diagnosis codes are grouped using
Hierarchical Condition Categories (HCCs), which are clinically relevant
diagnostic groups of codes. The CCs used in the risk-adjustment model
for this measure are provided on the CMS QualityNet Web site at:
https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier4&cid=1219069856694.
In summary, age, sex, and comorbidities present at the time of
admission are adjusted for differences in hospital case mix (patient
risk factors). The measure uses the hierarchical logistic regression
model (HLM) statistical methodology for risk adjustment.
(f) Calculating the Risk-Standardized Mortality Ratio (RSMR) and
Performance Period
We propose to calculate hospital 30-day, all-cause, risk-
standardized mortality rates consistent with the methodology used to
risk standardize all readmission and mortality measures used in CMS
hospital quality programs. Using HLM, we calculate the hospital-level
risk-standardized mortality rate following AMI hospitalization by
producing a ratio of the number of ``predicted'' deaths (that is, the
adjusted number of deaths at a specific hospital) to the number of
``expected'' deaths (that is, the number of deaths if an average
quality hospital treated the same patients) for each hospital and then
multiplying the ratio by the national raw mortality rate.
A 3-year rolling period for calculating measure results would be
consistent with the time frame used for the HIQR Program (FY 2008 IPPS/
LTCH final rule 71 FR 67960). Section III.E.5. of this proposed rule,
Form, Manner, and Timing of Quality Measure Submission, summarizes the
proposed measure performance periods for AMI model performance years 1
through 5. We note that, for each performance year, improvement on the
MORT-30-AMI (NQF #0230) measure would be determined by comparing
measure results from that performance year to results in the 3-year
rolling
[[Page 50895]]
measurement period immediately preceding each AMI model performance
year to results from the 3-year period from July 1, 2014 through June
30, 2017, for performance year 2 by comparing measure results in this
year to results from the 3-year period from July 1, 2015 through June
30, 2018, in performance year 3 by comparing measure results in this
year to results from the 3-year period from July 1, 2016 and June 30,
2019, in performance year 4 by comparing measure results in this year
to results from the 3-year period from July 1, 2017 and June 30, 2020,
and in performance year 5 by comparing measure results in this year to
results from the 3-year period from July 1, 2018 and June 30 2021.
The proposal to include Hospital-level 30-Day, All-Cause, Risk-
Standardized Mortality Rate (RSMR) following AMI hospitalization (NQF
#0230) measure in the AMI model is included in Sec. 512.411(a)(1). We
seek comment on this proposal to include Hospital-level 30-Day, All-
Cause, Risk-Standardized Mortality Rate (RSMR) following AMI
hospitalization (NQF #0230) measure in the AMI model to assess quality
performance.
(2) Excess Days in Acute Care after Hospitalization for Acute
Myocardial Infarction (AMI Excess Days)
(a) Background
The Excess Days in Acute Care after Hospitalization for Acute
Myocardial Infarction (AMI) measure (AMI Excess Days) is a risk-
standardized outcome measure that compares the number of days that
patients are predicted to spend in acute care across the full spectrum
of possible acute care events (hospital readmissions, observation
stays, and ED visits) after discharge from a hospital for AMI, to the
days patients are expected to spend in acute care based on their degree
of illness.
Some of the costs for AMI can be attributed to high acute care
utilization for post-discharge AMI patients in the form of
readmissions, observation stays, and emergency department (ED) visits.
We note that patients admitted for AMI have disproportionately high
readmission rates, and that readmission rates following discharge for
AMI are highly variable across hospitals in the United
States.78,79
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\78\ Krumholz HM, Merrill AR, Schone EM et al. Patterns of
hospital performance in acute myocardial infarction and heart
failure 30-day mortality and readmission. Circulation.
Cardiovascular Quality & Outcomes. Sep 2009;2(5):407-413.
\79\ Bernheim SM, Grady JN, Lin Z, et al. National patterns of
risk-standardized mortality and readmission for acute myocardial
infarction and heart failure. Update on publicly reported outcomes
measures based on the 2010 release. Circulation. Cardiovascular
Quality & Outcomes. Sep 2010;3(5):459-467.
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For the previously adopted HIQR Program measure, Hospital 30-Day,
All-Cause Risk- Standardized Readmission Rate (RSRR) following Acute
Myocardial Infarction (AMI) Hospitalization (NQF #0505) (CY 2009 OPPS/
ASC final rule with comment period; 73 FR 68780 through 68781),
publicly reported 30-day risk-standardized readmission rates for AMI
ranged from 17.5 percent to 30.3 percent for the time period between
July 2011 and June 2012.\80\ However, in addition to an increased risk
of requiring readmission in the post-discharge period, patients are
also at risk of returning to the hospital for both observation stays
and ED visits which also characterize potentially preventable acute
care. ED visits represent a significant proportion of post-discharge
acute care utilization for all conditions, including patients with AMI.
Two recent studies conducted in patients of all ages showed that 9.5
percent of patients return to the ED within 30 days of hospital
discharge; additionally, about 12 percent of these patients are
initially discharged from the ED and are not captured by the previously
adopted HIQR Program readmission measures.\8.9\ The rising use of
observation stays among Medicare beneficiaries between 2001 and 2008
sparked concern among patients, providers, and policymakers that the
AMI 30-day Readmission (NQF #0505) measure does not capture the full
range of unplanned acute care events that occur in the post-discharge
period. In order to address the rising use of observation stays amongst
Medicare beneficiaries CMS is proposing the Excess Days in Acute Care
after Hospitalization for AMI (AMI Excess Days) measure for use in the
AMI model. The AMI Excess Days measure comprehensively captures all
post-discharge, unplanned acute care events as a count of the excess
days a hospital's patients spent as inpatients, in observation, or in
the ED over a 3-year measurement period.
---------------------------------------------------------------------------
\80\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook Performance Report on Outcome Measures
September 2013. September 2013; Available at: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Downloads/-Medicare-Hospital-Quality-Chartbook-2013.pdf.
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In 2014, we developed the proposed measure of excess days in acute
care following AMI hospitalization, supported for use in the Hospital
Quality Reporting Program by the MAP and submitted to the NQF for
endorsement. We note that this measure was submitted for endorsement to
the NQF All-Cause Admissions and Readmissions Committee in January 2016
with appropriate consideration for sociodemographic status. The measure
was finalized for the HIQR Program FY 2018 payment determination (FY
2016 IPPS/LTCH final rule 80 FR 49690).
(b) Data Sources
We propose to use Medicare Part A and Part B FFS claims submitted
by the AMI model participant as the data source for calculation of the
AMI Excess Days measure as harmonized with the MORT-30-AMI(NQF #0230)
and READM-30-AMI(NQF #0505) measures. Index admission diagnoses and in-
hospital comorbidities are assessed using Medicare Part A claims.
Additional comorbidities prior to the index admission are assessed as
Part A inpatient, outpatient, and Part B office visit Medicare claims
in the 12 months prior to the index (initial) admission. Enrollment and
post-discharge mortality status are obtained from Medicare's enrollment
database which contains beneficiary demographic, benefits/coverage, and
vital status information.
(c) Cohort
The AMI Excess Days measure includes Medicare FFS beneficiaries,
aged 65 years or older, discharged from non-federal acute care
hospitals with a principal discharge diagnosis of AMI and with a
complete claims history for the 12 months prior to index admission.
Eligible hospitalizations are defined using the following ICD-10-CM
codes: I2109, I2111, I2119, I2129, I214, and I213.
We propose that the measure will include index admissions to all
non-federal acute care hospitals, which includes all participants in
the AMI model. Hospital performance will only be publically reported
for hospitals with 25 or more index admissions in the 3-year
measurement period. The AMI model cohort would differ from the hospital
cohort that is currently captured in the measure through the HIQR
Program. Although performance on the measure will not be publically
reported for hospitals with fewer than 25 cases, such hospitals will
receive information about their performance on the measure. We refer
readers to section III.B.5. of this proposed rule for a discussion of
AMI model participant selection.
(d) Inclusion and Exclusion Criteria
We propose that an index admission is the hospitalization to which
the excess days in acute care outcome is attributed. We note that for
purposes of
[[Page 50896]]
the EPMs where we need to identify episodes that are included in the
EPMs, we use the terms anchor and chained anchor hospitalization to
identify hospitalizations that initiate EPM episodes for beneficiaries
whose care is included in the EPMs. In describing the quality measures
themselves in detail in section III.E.4. of this proposed rule, we use
the term index hospitalization to identify hospitalizations of
beneficiaries whose outcomes are included in the measures. Thus, anchor
hospitalizations and index hospitalizations would have varying degrees
of overlap depending on the specific quality measure. The measure
includes the following index admissions for patients:
Having a principal discharge diagnosis of AMI.
Enrolled in Medicare FFS.
Aged 65 or over.
Not transferred from another acute care facility.
Enrolled in Medicare Part A and Part B for the 12 months
prior to the date of index admission, and enrolled in Part A during the
index admission.
The measure excludes the following index admissions for patients:
Discharged alive on the day of index admission or the
following day who were not transferred to another acute care facility.
With inconsistent or unknown vital status or other
unreliable demographic (age & gender) data.
Enrolled in the Medicare hospice program any time in the
12 months prior to the index admission, including the first day of the
index admission.
Discharged AMA.
Without at least 30 days of post-discharge enrollment in
FFS Medicare as the 30-day excess days outcome cannot be assessed for
these patients.
Finally, for the purpose of this measure, hospitalizations that
occur within 30 days of discharge from an index admission are not
eligible to also be index admission. Thus, only one index admission for
AMI per beneficiary is randomly selected for inclusion in the cohort.
(e) Risk-Adjustment
We propose for the AMI model to align this measure with the risk-
adjustment methodologies adopted for the AMI Excess Days measure under
the HIQR Program in accordance with section 1886(b)(3)(B)(viii)(VIII)
of the Act, as finalized in the FY 2016 IPPS/LTCH final rule (80 FR
49682). We also note that the measure risk adjustment takes into
account patient age, sex, and comorbidities to allow a fair assessment
of hospital performance. The measure defines the patient risk factors
for excess days using diagnosis codes collected from all patient claims
1 year prior to a patient's index hospitalization for AMI. Accordingly,
only comorbidities that convey information about the patient at the
time of index admission or in the 12 months prior, and not
complications that arise during the course of the index
hospitalization, are included in the risk-adjustment model. The measure
does not adjust for patients' index admission source or their discharge
disposition (for example, SNF) because these factors are associated
with the structure of the healthcare system, not solely patients'
clinical comorbidities. Regional differences in the availability of
post-acute care providers and practice patterns might also exert undue
influence on measure results. In addition, data fields that capture
discharge disposition, for example to post-acute care settings, on
inpatient claims are not audited and are not as reliable as diagnosis
codes.
As previously noted in the AMI Excess Days measure, ICD-10-CM
diagnosis codes present on Parts A and B administrative claims are used
to inform the risk prediction for each patient. Diagnostic codes from
post-acute care settings are utilized in the measure calculation, but
this information is only used to identify a hospital's patient case mix
in order to adequately adjust for differences in case mix across
hospitals. We note that the patient diagnosis codes are grouped using
HCCs, which are clinically relevant diagnostic groups of codes. The CCs
used in the risk-adjustment model for this measure are provided on the
CMS QualityNet Web site: https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier4&cid=1219069856694.
In summary, age, sex, and comorbidities present at the time of
index admission are adjusted for differences in hospital case mix
(patient risk factors). The measure uses the HLM statistical
methodology for risk adjustment.
(f) Calculating the Rate and Performance Period
We propose to calculate hospital 30-day excess days in acute care
with the methodology used to risk standardize all excess days measures
used in CMS hospital quality programs. The outcome of the measure is a
count of the number of days the patient spends in acute care within 30
days of discharge. We define days in acute care as days spent in an ED,
admitted to an observation unit, or admitted as an unplanned
readmission for any cause within 30 days from the date of discharge
from the index AMI hospitalization. Each ED treat-and-release visit is
counted as 1 half-day (0.5 days). Observation stays are recorded in
terms of hours and are rounded up to the nearest half-day. Each
readmission day is counted as 1 full day (1 day). We count all eligible
outcomes occurring in the 30-day period, even if they are repeat
occurrences. The measure incorporates ``exposure time'' (the number of
days each patient survives after discharge, up to 30). This exposure
time is included to account for differential risk for excess days in
acute care after discharge among those patients who do not survive the
full post-discharge period. If a readmission or observation stay
extends beyond the 30-day window, only those days within the 30-day
window are counted.
Using a two-part random effects model, or ``hurdle'' model, we
account for the structure of the data (patients clustered within
hospitals) and the observed distribution of the outcome. Specifically,
we model the number of acute care days for each patient as: (a) The
probability that the patient will have a non-zero number of days in
post-discharge acute care; and (b) the number of days the patient is
predicted to spend given that this number is non-zero. The first part
is specified as a legit model, and the second part is specified as a
Poisson model, with both parts having the same risk-adjustment
variables and each part having a random effect. This model is used to
calculate the predicted (including random effects) and expected
(assuming random effects are zero) number of days in post-discharge
acute care for each patient. The average difference between patients'
predicted and expected estimates for each hospital is used to construct
the risk-standardized excess days outcome. The excess days outcome is
reported at the hospital-level per 100 discharges.
We define the time period for the measure as within 30 days of the
date of discharge of the index AMI hospitalization. The 30-day post-
discharge window for assessing the outcome is consistent with the
claims-based MORT-30-AMI (NQF #0230) and Hybrid AMI Mortality (NQF
#2473) measures as noted in this proposed rule.
A 3-year rolling performance period would be consistent with that
used for the HIQR Program (FY 2016 IPPS/LTCH final rule 80 FR 49681).
Section III.E.5., Form, Manner, and Timing of Quality Measure Data
Submission, of this proposed rule summarizes the proposed measure
performance periods for AMI model performance years 1 through 5. We
note that improvement on the AMI
[[Page 50897]]
Excess Days measure would be determined from the immediate 3-year
rolling performance period available for the year preceding the AMI
model performance year as explained in Table 30.
The proposal to include the Excess Days in Acute Care after
Hospitalization for AMI measure in the AMI model is included in Sec.
512.411(a)(2). We seek comment on this proposal to include the Excess
Days in Acute Care after Hospitalization for AMI measure in the AMI
model to assess quality performance.
(3) Hybrid Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate
Following Acute Myocardial Infarction (AMI) Hospitalization (NQF#
2473)(Hybrid AMI Mortality)
(a) Background
In keeping with our goal to move toward the use of EHRs, and in
response to stakeholder feedback to include clinical data in outcome
measures, we have developed the hospital 30-day risk-standardized acute
myocardial infarction (AMI) mortality eMeasure (NQF #2473) (herein
after referred to as Hybrid AMI Mortality measure). This measure will
incorporate a combination of claims data and EHR data submitted by
hospitals, and because of these combined data sources, it is referred
to as a hybrid measure. The Hybrid AMI Mortality (NQF #2473) measure
cohort and outcome are identical to those in the hospital 30-day, all-
cause, risk-standardized mortality rate (RSMR) following acute
myocardial infarction (AMI) (NQF #0230), measure which is also being
proposed in the AMI model.
In contrast to the claims-only MORT-30-AMI (NQF #0230) measure, the
proposed Hybrid AMI Mortality (NQF #2473) measure utilizes five core
clinical data elements (age; heart rate; systolic blood pressure;
troponin; creatinine) in the risk-adjustment methodology that are
obtainable through EHR data. These five core clinical data elements are
intended to reflect patients' clinical status when they first present
to an acute care hospital for treatment of AMI. The clinical data
elements include age at the time of admission, first-captured vital
signs (heart rate, systolic blood pressure) collected within 2 hours of
the patient first presenting to the hospital, and the first captured
laboratory values (troponin, creatinine) collected within 24 hours of
the patient first presenting to the hospital to which they are
subsequently admitted. We note that these five data elements are
routinely collected on hospitalized adults with AMI upon presentation
to the hospital, consistently captured in medical records under current
clinical practice, and can be feasibly electronically extracted from
hospital EHRs.
In order to prepare for future reporting of the Hybrid AMI
Mortality (NQF #2473) measure, we are proposing to seek and reward
voluntary data submission of the five core clinical data elements
included in the risk model for the Hybrid AMI mortality (NQF #2473)
measure. We are also proposing to require submission of six additional
linking variables (CCN, HIC Number, date of birth, sex, admission date,
and discharge date) to ensure that the datasets containing
administrative claims data are correctly linked with EHR datasets
containing the core clinical data elements for proper risk adjustment.
The voluntary data submission initiative will allow AMI model
participants to build processes to extract and report the EHR data
elements, as well as support CMS testing of systems required for Hybrid
AMI Mortality measure (NQF #2473) production including data receiving
and auditing, the merging EHR and claims data, calculation and
production of measure results.
Finally, we are considering using the Hybrid AMI Mortality (NQF
#2473) measure as a replacement for the current publicly reported MORT-
30-AMI (NQF #0230) measure in CMS models or programs when appropriate.
In future years CMS may implement the Hybrid AMI Mortality (NQF #2473)
measure in models and/or programs, such as in the AMI model or HIQR
Program. In that event, we would propose to adopt the measure through
notice and comment rulemaking. We refer readers to more detailed
information on the measure specifications in this proposed rule and to
the CMS Web site at: http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
(b) Data Sources
We propose to use two sources of data submitted by AMI model
participants to calculate the Hybrid AMI Mortality (NQF #2473) measure:
Medicare Part A and Part B (FFS claims to identify index admission
diagnoses; and EHR-captured clinical information collected at
presentation for risk-adjustment of patients' severity of illness.
Deaths are identified using the Medicare Enrollment Database which
contains beneficiary demographic, benefits/coverage, and vital status
information.
For the voluntary data submission initiative, EHR data submission
will align with existing Electronic Clinical Quality Measure (eCQM)
standards and data reporting procedures for hospitals. In alignment
with these standards, we are posting the electronic specifications for
the Hybrid AMI Mortality (NQF #2473) measure, which include the Measure
Authoring Tool (MAT) output and value sets for all included data
elements, on the CMS Web site at: http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
The Office of the National Coordinator for Health Information
Technology (ONC) adopted quality reporting document architecture (QRDA)
as the standard to support both QRDA Category I (individual patient)
and QRDA Category III (aggregate) data submission approaches for
Meaningful Use Stage 2 in the Health Information Technology: Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology rule
(77 FR 54163 through 54292). We intend to provide AMI model
participants with information about how many qualifying admissions are
submitted successfully. We refer readers to the definition of
``successful data submission'' in section III. E.4.a.(3)(vii) of this
proposed rule.
We seek comment on our proposal to use the following reporting
mechanisms in performance year 1: QRDA, a simpler mechanism such as a
spreadsheet, or both. We propose using QRDA in AMI model performance
years 2 through 5. The purpose of the use of a simpler reporting format
in the first performance year reporting format in the first performance
year would be to allow hospitals to perfect data extraction with the
2017 data and postpone mastery of reporting in the QRDA format to the
following year.
(c) Cohort
The Hybrid AMI Mortality (NQF #2473) measure includes Medicare FFS
beneficiaries, aged 65 years or older, discharged from non-federal
acute care hospitals with a principal discharge diagnosis of AMI.
Eligible hospitalizations are defined using the following ICD-10-CM
codes: I2109, I2111, I2119, I2129, I214, and I213.
Hospital performance for the Hybrid AMI Mortality (NQF #2473)
measure will not be publicly reported. However, AMI model participants
will receive hospital-specific reports for each performance year with
information about the success of their voluntary submission of EHR
data.
[[Page 50898]]
(d) Inclusion and Exclusion Criteria
We propose that an index admission is the hospitalization to which
the mortality outcome is attributed. The Hybrid AMI mortality (NQF
#2473) measure includes the following index admissions for patients:
Having a principal discharge diagnosis of AMI.
Enrolled in Medicare FFS.
Aged 65 or over.
Not transferred from another acute care facility.
Enrolled in Medicare Part A and Part B for the 12 months
prior to the date of index admission, and enrolled in Part A during the
index admission.
This measure excludes the following index admissions for patients:
Discharged alive on the day of admission or the following
day who were not transferred to another acute care facility.
With inconsistent or unknown vital status or other
unreliable demographic (age & gender) data.
Enrolled in the Medicare hospice program any time in the
12 months prior to the index admission, including the first day of the
index admission.
Discharged AMA.
Without at least 30 days of post-discharge enrollment in
FFS Medicare as the 30-day mortality outcome cannot be assessed for
these patients.
Finally, for the purpose of this measure, only one index admission
per patient for AMI is randomly selected for inclusion in the cohort.
(e) Risk-Adjustment
We note that this measure is aligned with the methodology approach
adopted for the MORT-30-AMI (NQF #0230) measure under the HIQR Program
in accordance with section 1886(b)(3)(B)(viii)(VIII) of the Act, as
finalized in FY 2008 IPPS/LTCH final rule (2008 IPPS/LTCH final rule 71
FR 67960). The Hybrid AMI Mortality (NQF #2473) measure uses EHR data
and not administrative claims data to adjust for differences across
hospitals in how at-risk their patients are for death, relative to
patients cared for by other hospitals. The risk model was developed
with input from the literature, clinical and EHR experts, and Health
Information Technology vendors. In order to be included as risk
variables, clinical data elements had to be--(1) consistently obtained
in the target population (Medicare FFS AMI patients) based on current
clinical practice; (2) captured with a standard definition and recorded
in a standard format within the EHR; and (3) entered in structured
fields that are feasibly retrieved from current EHR systems. The final
measure includes five variables that meet these feasibility criteria,
are present for most patients at the time of clinical presentation to
the hospital, are clinically relevant to patients with AMI, and
demonstrate a strong statistical association with 30-day mortality.
Hospitals will submit the first-captured data values of each of the
five core clinical data elements upon patient presentation to the
hospital. They are: Age; the first-captured heart rate and systolic
blood pressure measured within 2 hours of a patient presenting to the
hospital; and the first captured troponin and creatinine values within
24 hours of a patient presenting to the hospital. Although EHRs likely
will ultimately link across clinical episodes of care and contain
historical patient data, given the EHR environment at the time of
measure development and inability to reliably obtain data from the
outpatient setting prior to admission, we only considered for inclusion
those measure variables that would be available and consistently
collected at first presentation to the hospital.
The overall performance of the model was comparable with or better
than that of current publicly reported outcome measures.\81\ We tested
measure score validity by correlating the RSMR with that of the
previously validated, publicly reported, administrative claims-based
MORT-30-AMI (NQF #0230) measure. For more detailed information on the
model performance, we refer readers to the CMS Web site at: http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
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\81\ AMI Mortality Hybrid Measure methodology report. http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
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(f) Calculating the Risk-Standardized Mortality Ratio (RSMR) and
Performance Period
We calculate hospital 30-day, all-cause, risk-standardized
mortality rates consistent with the methodology used to risk
standardize all readmission and mortality measures used in CMS hospital
quality programs. Using an HLM statistical methodology for risk
adjustment, we calculate the hospital-level risk-standardized mortality
rate following AMI hospitalizations by producing a ratio of the number
of ``predicted'' deaths (that is, the adjusted number of deaths at a
specific hospital) to the number of ``expected'' deaths (that is, the
number of deaths if an average quality hospital treated the same
patients) for each hospital and then multiplying the ratio by the
national observed mortality rate.
We propose defining AMI model performance years as outlined in
section III.E.5. of this proposed rule. A performance period for the
voluntary data submission are those timeframes in which a hospital
discharge occurs for an eligible AMI index hospitalization. For
performance year 1 of the AMI model, participants voluntarily
submitting data will only be asked to submit data for a 2-month period.
The 2-month period for AMI voluntary data reporting was identified due
to data processing and coordination with other proposed timelines for
this model. Data submitted for the first year would be for cases that
fulfill the measure specifications described in section III.E.4.a.(3)
of this proposed rule, and would be restricted to the data elements
from eligible AMI index hospitalizations with discharges occurring
between July 1, 2017 and August 31, 2017.
For performance year 2 of the AMI model, AMI voluntary data
reporting would be 10 months of data for discharges from eligible AMI
hospitalizations occurring between September 1, 2017 and June 30, 2018.
For subsequent years of the model, the performance periods for
submission of voluntary data will consist of discharges within
calendar-year 12-month time periods from July 1 through June 30. The
proposed performance periods would enable AMI model participants to
receive points toward the AMI model composite quality score for data
submission starting in performance year 1. We seek comment on our
proposal for defining the data reporting period for performance year 1
episodes for an AMI model participant as eligible AMI index
hospitalizations with discharges occurring between July 1, 2017 and
August 31, 2017, and for performance year 2 as eligible AMI
hospitalizations with discharges occurring between September 1, 2017
and June 30, 2018, with subsequent performance year data reporting
periods each being calendar-year 12 month periods and starting every
July 1st. Refer to Table 30 for summary of proposed performance
periods.
(g) Requirements for Successful Submission of AMI Voluntary Data
In order for CMS to assess if AMI model participants that submit
the AMI voluntary data are eligible for points toward the hospital's
AMI model composite quality score, we propose to use the following
criteria to determine if a participant has successfully submitted AMI
voluntary data:
[[Page 50899]]
Submission of the first-captured data values for the five core clinical
data elements (age; first-captured heart rate and systolic blood
pressure measured within 2 hours of a patient presenting to the
hospital; and first-captured troponin and creatinine values measured
within 24 hours of a patient presenting to the hospitals), and six
linking variables required to merge with the CMS claims data CCN, HIC
Number, date of birth, sex, admission date, and discharge date).
All of these data elements must be submitted for each qualifying
AMI hospitalization as described in section III.E.5. of this proposed
rule. If troponin was not measured in the patient within 24 hours of
presentation to the hospital, the hospital will still receive credit
for successful data submission if all other clinical data elements
(age, heart rate, systolic blood pressure, and creatinine) as well as
the six linking variables are all reported in the submission. We
recognize that some patients may have clinical signs or symptoms that
require emergent treatment; and that in such cases treatment might
proceed without first obtaining a troponin level. However hospitals are
required to report troponin values on all patients in whom a troponin
test was performed within the first 24 hours of presenting to the
hospital and to indicate in their data submission each instance in
which a troponin value was not measured and therefore not available for
a patient.
AMI voluntary data submission must occur within 60 days of the end
of the most recent data collection period as described in the listing
of reporting periods for all 5 model performance years in section
III.E.5. of this proposed rule.
To fulfill AMI voluntary data collection criteria for model
performance year 1, hospitals must submit valid data on 50 percent of
qualifying AMI hospitalizations (identified by the denominator in the
measure authorizing tool (MAT) output). To successfully submit AMI
voluntary data for performance years 2 through 5, hospitals must submit
valid data for all five core clinical data elements on over 90 percent
of qualifying AMI patients (with the exception for troponin values
described in this section). Further details on scoring of the voluntary
data submission are discussed in section III.E.3.e.(1) of this proposed
rule.
Each year, AMI model participants voluntarily submitting data for
this measure will receive hospital-specific reports that detail
submission results from the most recent performance period. The reports
will include the match rate between the hospital's submitted EHR data
and corresponding claims data, as well as the proportion of patient
data submitted relative to all qualifying AMI admissions with all five
core clinical data elements. As the initiative seeks to test and reward
hospitals' ability to submit data, hospitals will not be penalized for
missing troponin values for patients in whom these values were not
measured at the time clinical treatment was provided. If hospitals
successfully submit the remaining four clinical data elements and all
of the linking variables, a missing troponin value which is due to
troponin having not been measured in that patient will not result in an
unsuccessful submission as long as hospitals indicate that the troponin
value was not measured and therefore not available for that patient.
Hospitals will still be rewarded for successfully submitting data in
these cases.
We previously described a qualifying AMI patient in section
III.E.4.a.(3)(iii) of this proposed rule. This description is
important, as these patients are those for whom we seek submission of
voluntary data from AMI model participants. We selected the requirement
of submitting 90 percent of qualifying AMI patients' data for
performance years 2 through 5 because this volume of cases will result
in a high probability that we will have a national sample of AMI
patient data representative of each hospital's patient case mix. Having
90 percent of the data for qualifying AMI patients in performance years
2 through 5 will enable an accurate and reliable assessment of the
potential implementation of a Hybrid AMI mortality (NQF #2473) measure
that utilizes EHR data. In addition, the testing we have performed in
hospitals' EHR data indicate that these data elements are captured in
over 90 percent of Medicare FFS patients who are 65 years or older and
admitted to acute care hospitals for treatment of AMI.
We seek public comment on the proposed requirements to determine
successful voluntary submission of AMI data, including the proposal to
give hospitals credit for data submission if they submit all troponin
values that were actually measured, each of the other four data
elements, and all of the linking variables; to not penalize hospitals
for failure to submit a troponin value if it was not measured during
the admission; and the proposal on the specific minimum percentage
requirements for data on the qualifying AMI patients.
b. CABG Model-Specific Measure
(1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR)
Following Coronary Artery Bypass Graft (CABG) Surgery (NQF #2558)(MORT-
30-CABG)
(a) Background
CABG is a common procedure associated with considerable morbidity,
mortality, and healthcare spending. In 2010, the National Hospital
Discharge Survey (NHDS) estimated that 219,000 patients underwent a
total of 397,000 CABG procedures. Among Medicare FFS beneficiaries,
there were 139,133 hospitalizations for isolated CABG surgery between
July 2012 and June 2015. CABG surgeries are costly procedures that
account for the majority of major cardiac surgeries performed
nationally. In FY 2009, isolated CABG surgeries accounted for almost
half (47.6 percent) of all cardiac surgery hospital admissions in
Massachusetts. This provides an example of the frequency in which a
CABG is performed for a patient admitted for cardiac surgery. In 2008,
the average Medicare IPPS payment was $30,546 for CABG without valve
replacement and $47,669 for CABG with valve replacement surgeries.
The proposed Hospital-level 30-Day Risk-Standardized Mortality Rate
(RSMR) following Coronary Artery Bypass Graft (CABG) Surgery (MORT-30-
CABG) (NQF #2558) measure developed by CMS and currently implemented in
the HIQR program, assesses hospitals' 30-day, all-cause risk-
standardized rate of mortality, which is rate of death after admission
for a CABG procedure for patients 65 and older during a 30-day period
that begins with the date of the index admission for the specific
hospital; an index admission is the hospitalization to which the
mortality outcome is attributed. The data indicate that the median
hospital-level risk-standardized mortality rate for 2016 public
reporting on Hospital Compare was 3.2 percent, with a range of 1.4
percent to 8.3 percent among hospitals. The variation in these rates
suggests that important differences in the quality of care delivered
across hospitals exist, and that there is room for improvement.
More details about the measure can be found in the 2016 Annual
Updates and Specifications Report for CABG Mortality posted on the CMS
Web site at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
The proposed MORT-30-CABG (NQF #2558) measure was endorsed by the
NQF in November 2014. This measure
[[Page 50900]]
has been publicly reported on Hospital Compare since FY 2015 and was
incorporated into the HIQR Program for FY 2017 (FY 2015 IPPS/LTCH final
rule 79 FR 50227).
(b) Data Source
Measure results for CABG model participants are calculated using
Medicare Part A and Part B FFS claims submitted by all non-federal
short-term acute care hospitals for the MORT-30-CABG (NQF #2558)
measure. Index admission diagnoses and in-hospital comorbidities are
assessed using Medicare Part A claims. Additional comorbidities prior
to the index admission are assessed as Part A inpatient, outpatient,
and Part B office visit Medicare claims in the 12 months prior to the
index (initial) admission. Enrollment and post-discharge mortality
status are obtained from Medicare's enrollment database which contains
beneficiary demographic, benefits/coverage, and vital status
information.
(c) Cohort
The MORT-30-CABG (NQF #2558) measure includes Medicare FFS
beneficiaries, aged 65 years and older, discharged from a non-federal
short-term acute care hospitals (including Indian Health Services
hospitals) and critical access hospitals, who received a qualifying
CABG procedure, and with a complete claims history for the 12 months
prior to admission and through 30 days post-procedure.
We propose that the measure will include index admissions to all
non-federal acute care hospitals, which includes all hospitals in the
CABG model. Hospital performance will only be publically reported for
hospitals with 25 or more index admissions in the 3-year measurement
period. The CABG model cohort would differ from the hospital cohort
that is currently captured in the measure through the HIQR Program.
Although performance on the measure will not be publicly reported for
hospitals with fewer than 25 cases, such hospitals will receive
information about their performance. We refer readers to section
III.B.5. of this proposed rule for a discussion of CABG model
participant selection. For eligible hospitalizations defined using ICD-
9-CM codes, we refer readers to the CMS Web site at: http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
In order to include a clinically coherent set of patients in the
measure, we sought input from clinical experts regarding the inclusion
of other concomitant cardiac and non-cardiac procedures, such as valve
replacement and carotid endarterectomy. Adverse clinical outcomes
following such procedures are higher than those following ``isolated''
CABG procedures, that is, CABG procedures performed without concomitant
high-risk cardiac and non-cardiac procedures. Limiting the measure
cohort to ``isolated'' CABG patients is consistent with published
reports of CABG outcomes; therefore, the measure cohort considers only
patients undergoing isolated CABG as eligible for inclusion in the
measure. We defined isolated CABG patients as those undergoing CABG
procedures without concomitant valve or other major cardiac, vascular
or thoracic procedures. In addition, our clinical experts, consultants,
and Technical Expert Panel (TEP) members agreed that an isolated CABG
cohort is a clinically coherent cohort for quality measurement. For
detailed information on the cohort definition, we refer readers to the
2016 Annual Updates and Specifications Report for CABG Mortality on the
CMS Web site at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
(d) Inclusion and Exclusion Criteria
We propose that an index admission is the hospitalization to which
the mortality outcome is attributed. The measure includes the following
index admissions for patients:
Having a qualifying isolated CABG surgery during the index
admission;
Enrolled in Medicare FFS Part A and Part B for the 12
months prior to the date of the index admission, and enrolled in Part A
during the index admission; and,
Aged 65 or over.
Isolated CABG surgeries are defined as those CABG procedures
performed without the following concomitant valve or other major
cardiac, vascular, or thoracic procedures:
Valve procedures.
Atrial and/or ventricular septal defects.