Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program, 24323-24689 [2015-09245]
Download as PDF
Vol. 80
Thursday,
No. 83
April 30, 2015
Part II
Department of Health and Human Services
Centers for Medicare & Medicaid Services
42 CFR Part 412
Office of the Secretary
tkelley on DSK3SPTVN1PROD with PROPOSALS2
45 CFR Part 170
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions
of Quality Reporting Requirements for Specific Providers, Including
Changes Related to the Electronic Health Record Incentive Program;
Proposed Rule
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Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 412
Office of the Secretary
45 CFR Part 170
[CMS–1632–P]
RIN–0938–AS41
Medicare Program; Hospital Inpatient
Prospective Payment Systems for
Acute Care Hospitals and the LongTerm Care Hospital Prospective
Payment System Policy Changes and
Fiscal Year 2016 Rates; Revisions of
Quality Reporting Requirements for
Specific Providers, Including Changes
Related to the Electronic Health
Record Incentive Program
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
We are proposing to revise the
Medicare hospital inpatient prospective
payment systems (IPPS) for operating
and capital-related costs of acute care
hospitals to implement changes arising
from our continuing experience with
these systems for FY 2016. Some of
these changes implement certain
statutory provisions contained in the
Patient Protection and Affordable Care
Act and the Health Care and Education
Reconciliation Act of 2010 (collectively
known as the Affordable Care Act), the
Pathway for Sustainable Growth Reform
(SGR) Act of 2013, the Protecting Access
to Medicare Act of 2014, and other
legislation. We also are addressing the
update of the rate-of-increase limits for
certain hospitals excluded from the
IPPS that are paid on a reasonable cost
basis subject to these limits for FY 2016.
We also are proposing to update the
payment policies and the annual
payment rates for the Medicare
prospective payment system (PPS) for
inpatient hospital services provided by
long-term care hospitals (LTCHs) for FY
2016 and implement certain statutory
changes to the LTCH PPS under the
Affordable Care Act and the Pathway for
Sustainable Growth Rate (SGR) Reform
Act of 2013 and the Protecting Access
to Medicare Act of 2014.
In addition, we are proposing to
establish new requirements or to revise
existing requirements for quality
reporting by specific providers (acute
care hospitals, PPS-exempt cancer
hospitals, and LTCHs) that are
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SUMMARY:
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participating in Medicare, including
related proposals for eligible hospitals
and critical access hospitals
participating in the Medicare Electronic
Health Record (EHR) Incentive Program.
We also are proposing to update policies
relating to the Hospital Value-Based
Purchasing (VBP) Program, the Hospital
Readmissions Reduction Program, and
the Hospital-Acquired Condition (HAC)
Reduction Program.
DATES: Comment Period: To be assured
consideration, comments on all sections
of this proposed rule must be received
at one of the addresses provided in the
ADDRESSES section no later than 5 p.m.
EST on June 29, 2015.
ADDRESSES: In commenting, please refer
to file code CMS–1632–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may (and we
encourage you to) submit electronic
comments on this regulation to https://
www.regulations.gov. Follow the
instructions under the ‘‘submit a
comment’’ tab.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1632–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 via express
or overnight mail to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1632–P, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal Government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
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building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call the telephone number (410)
786–7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, we refer readers to the
beginning of the SUPPLEMENTARY
INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Ing-Jye Cheng, (410) 786–4548 and
Donald Thompson, (410) 786–4487,
Operating Prospective Payment, MS–
DRGs, Deficit Reduction Act HospitalAcquired Acquired Conditions—Present
on Admission (DRA HAC–POA)
Program, Hospital-Acquired Conditions
Reduction Program, Hospital
Readmission Reductions Program, Wage
Index, New Medical Service and
Technology Add-On Payments, Hospital
Geographic Reclassifications, Graduate
Medical Education, Capital Prospective
Payment, Excluded Hospitals, and
Medicare Disproportionate Share
Hospital (DSH) Issues.
Michele Hudson, (410) 786–4487,
Long-Term Care Hospital Prospective
Payment System and MS–LTC–DRG
Relative Weights Issues.
Siddhartha Mazumdar, (410) 786–
6673, Rural Community Hospital
Demonstration Program Issues.
Cindy Tourison, (410) 786–1093,
Hospital Inpatient Quality Reporting
and Hospital Value-Based Purchasing—
Program Administration, Validation,
and Reconsideration Issues.
Pierre Yong, (410) 786–8896, Hospital
Inpatient Quality Reporting—Measures
Issues Except Hospital Consumer
Assessment of Healthcare Providers and
Systems Issues.
Elizabeth Goldstein, (410) 786–6665,
Hospital Inpatient Quality Reporting—
Hospital Consumer Assessment of
Healthcare Providers and Systems
Measures Issues.
Mary Pratt, (410) 786–6867, LTCH
Quality Data Reporting Issues.
Kim Spalding Bush, (410) 786–3232,
Hospital Value-Based Purchasing
Efficiency Measures Issues.
James Poyer, (410) 786–2261, PPSExempt Cancer Hospital Quality
Reporting Issues.
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Deborah Krauss, (410) 786–5264, and
Alexandra Mugge, (410–786–4457), EHR
Incentive Program Clinical Quality
Measure Related Issues.
Elizabeth Myers, (410) 786–4751, EHR
Incentive Program Nonclinical Quality
Measure Related Issues.
Lauren Wu, (202) 690–7151, Certified
EHR Technology Related Issues.
Kellie Shannon, (410) 786–0416,
Simplified Cost Allocation Methodology
Issues.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All public
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 public
comments received before the close of
the comment period on the following
Web site as soon as possible after they
have been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
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 Publishing Office. This
database can be accessed via the
Internet at: https://www.gpo.gov/fdsys.
Tables Available Only Through the
Internet on the CMS Web site
In the past, a majority of the tables
referred to throughout this preamble
and in the Addendum to the proposed
rule and the final rule were published
in the Federal Register as part of the
annual proposed and final rules.
However, beginning in FY 2012, some of
the IPPS tables and LTCH PPS tables are
no longer published in the Federal
Register. Instead, these tables are
generally only available through the
Internet. The IPPS tables for this
proposed rule are available through the
Internet on the CMS Web site at: https://
www.cms.hhs.gov/Medicare/medicareFee-for-Service-Payment/
AcuteInpatientPPS/. Click on
the link on the left side of the screen
titled, ‘‘FY 2016 IPPS Proposed Rule
Home Page’’ or ‘‘Acute Inpatient—Files
for Download’’. The LTCH PPS tables
for this FY 2016 proposed rule are
available through the Internet on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/LongTermCareHospitalPPS/
index.html under the list item for
Regulation Number CMS–1632–P. For
further details on the contents of the
tables referenced in this proposed rule,
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we refer readers to section VI. of the
Addendum to this proposed rule.
Readers who experience any problems
accessing any of the tables that are
posted on the CMS Web sites identified
above should contact Michael Treitel at
(410) 786–4552.
Acronyms
3M 3M Health Information System
AAMC Association of American Medical
Colleges
ACGME Accreditation Council for Graduate
Medical Education
ACoS American College of Surgeons
AHA American Hospital Association
AHIC American Health Information
Community
AHIMA American Health Information
Management Association
AHRQ Agency for Healthcare Research and
Quality
AJCC American Joint Committee on Cancer
ALOS Average length of stay
ALTHA Acute Long Term Hospital
Association
AMA American Medical Association
AMGA American Medical Group
Association
AMI Acute myocardial infarction
AOA American Osteopathic Association
APR DRG All Patient Refined Diagnosis
Related Group System
APRN Advanced practice registered nurse
ARRA American Recovery and
Reinvestment Act of 2009, Public Law
111–5
ASCA Administrative Simplification
Compliance Act of 2002, Public Law 107–
105
ASITN American Society of Interventional
and Therapeutic Neuroradiology
ASPE Assistant Secretary for Planning and
Evaluation [DHHS]
ATRA American Taxpayer Relief Act of
2012, Public Law 112–240
BBA Balanced Budget Act of 1997, Public
Law 105–33
BBRA Medicare, Medicaid, and SCHIP
[State Children’s Health Insurance
Program] Balanced Budget Refinement Act
of 1999, Public Law 106–113
BIPA Medicare, Medicaid, and SCHIP [State
Children’s Health Insurance Program]
Benefits Improvement and Protection Act
of 2000, Public Law 106–554
BLS Bureau of Labor Statistics
CABG Coronary artery bypass graft
[surgery]
CAH Critical access hospital
CARE [Medicare] Continuity Assessment
Record & Evaluation [Instrument]
CART CMS Abstraction & Reporting Tool
CAUTI Catheter-associated urinary tract
infection
CBSAs Core-based statistical areas
CC Complication or comorbidity
CCN CMS Certification Number
CCR Cost-to-charge ratio
CDAC [Medicare] Clinical Data Abstraction
Center
CDAD Clostridium difficile-associated
disease
CDC Center for Disease Control and
Prevention
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CERT Comprehensive error rate testing
CDI Clostridium difficile (C. difficile)
CFR Code of Federal Regulations
CLABSI Central line-associated
bloodstream infection
CIPI Capital input price index
CMI Case-mix index
CMS Centers for Medicare & Medicaid
Services
CMSA Consolidated Metropolitan
Statistical Area
COBRA Consolidated Omnibus
Reconciliation Act of 1985, Public Law 99–
272
COLA Cost-of-living adjustment
COPD Chronis obstructive pulmonary
disease
CPI Consumer price index
CQM Clinical quality measure
CY Calendar year
DACA Data Accuracy and Completeness
Acknowledgement
DPP Disproportionate patient percentage
DRA Deficit Reduction Act of 2005, Public
Law 109–171
DRG Diagnosis-related group
DSH Disproportionate share hospital
EBRT External Bean Radiotherapy
ECI Employment cost index
eCQM Electronic clinical quality measure
EDB [Medicare] Enrollment Database
EHR Electronic health record
EMR Electronic medical record
EMTALA Emergency Medical Treatment
and Labor Act of 1986, Public Law 99–272
EP Eligible professional
FAH Federation of American Hospitals
FDA Food and Drug Administration
FFY Federal fiscal year
FPL Federal poverty line
FQHC Federally qualified health center
FR Federal Register
FTE Full-time equivalent
FY Fiscal year
GAF Geographic Adjustment Factor
GME Graduate medical education
HAC Hospital-acquired condition
HAI Healthcare-associated infection
HCAHPS Hospital Consumer Assessment of
Healthcare Providers and Systems
HCFA Health Care Financing
Administration
HCO High-cost outlier
HCP Healthcare personnel
HCRIS Hospital Cost Report Information
System
HHA Home health agency
HHS Department of Health and Human
Services
HICAN Health Insurance Claims Account
Number
HIPAA Health Insurance Portability and
Accountability Act of 1996, Public Law
104–191
HIPC Health Information Policy Council
HIS Health information system
HIT Health information technology
HMO Health maintenance organization
HPMP Hospital Payment Monitoring
Program
HSA Health savings account
HSCRC [Maryland] Health Services Cost
Review Commission
HSRV Hospital-specific relative value
HSRVcc Hospital-specific relative value
cost center
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HQA Hospital Quality Alliance
HQI Hospital Quality Initiative
HwH Hospital-within-hospital
IBR Intern- and Resident-to-Bed Ratio
ICD–9–CM International Classification of
Diseases, Ninth Revision, Clinical
Modification
ICD–10–CM International Classification of
Diseases, Tenth Revision, Clinical
Modification
ICD–10–PCS International Classification of
Diseases, Tenth Revision, Procedure
Coding System
ICR Information collection requirement
ICU Intensive care unit
IGI IHS Global Insight, Inc.
IHS Indian Health Service
IME Indirect medical education
I–O Input-Output
IOM Institute of Medicine
IPF Inpatient psychiatric facility
IPFQR Inpatient Psychiatric Facility
Quality Reporting [Program]
IPPS [Acute care hospital] inpatient
prospective payment system
IRF Inpatient rehabilitation facility
IQR Inpatient Quality Reporting
LAMCs Large area metropolitan counties
LOS Length of stay
LTC–DRG Long-term care diagnosis-related
group
LTCH Long-term care hospital
LTCH QRP Long-Term Care Hospital
Quality Reporting Program
MAC Medicare Administrative Contractor
MAP Measure Application Partnership
MCC Major complication or comorbidity
MCE Medicare Code Editor
MCO Managed care organization
MDC Major diagnostic category
MDH Medicare-dependent, small rural
hospital
MedPAC Medicare Payment Advisory
Commission
MedPAR Medicare Provider Analysis and
Review File
MEI Medicare Economic Index
MGCRB Medicare Geographic Classification
Review Board
MIEA–TRHCA Medicare Improvements and
Extension Act, Division B of the Tax Relief
and Health Care Act of 2006, Public Law
109–432
MIPPA Medicare Improvements for Patients
and Providers Act of 2008, Public Law
110–275
MMA Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173
MMEA Medicare and Medicaid Extenders
Act of 2010, Public Law 111–309
MMSEA Medicare, Medicaid, and SCHIP
Extension Act of 2007, Public Law 110–173
MRHFP Medicare Rural Hospital Flexibility
Program
MRSA Methicillin-resistant Staphylococcus
aureus
MSA Metropolitan Statistical Area
MS–DRG Medicare severity diagnosisrelated group
MS–LTC–DRG Medicare severity long-term
care diagnosis-related group
MU Meaningful Use [EHR Incentive
Program]
NAICS North American Industrial
Classification System
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NALTH National Association of Long Term
Hospitals
NCD National coverage determination
NCHS National Center for Health Statistics
NCQA National Committee for Quality
Assurance
NCVHS National Committee on Vital and
Health Statistics
NECMA New England County Metropolitan
Areas
NHSN National Healthcare Safety Network
NQF National Quality Forum
NQS National Quality Strategy
NTIS National Technical Information
Service
NTTAA National Technology Transfer and
Advancement Act of 1991, Public Law
104–113
NUBC National Uniform Billing Code
NVHRI National Voluntary Hospital
Reporting Initiative
OACT [CMS] Office of the Actuary
OBRA 86 Omnibus Budget Reconciliation
Act of 1986, Public Law 99–509
OES Occupational employment statistics
OIG Office of the Inspector General
OMB [Executive] Office of Management and
Budget
ONC Office of the National Coordinator for
Health Information Technology
OPM [U.S.] Office of Personnel
Management
OQR [Hospital] Outpatient Quality
Reporting
O.R. Operating room
OSCAR Online Survey Certification and
Reporting [System]
PAC Postacute care
PAMA Protecting Access to Medicare Act of
2014, Public Law 113–93
PCH PPS-exempt cancer hospital
PCHQR PPS-exempt cancer hospital quality
reporting
PMSAs Primary metropolitan statistical
areas
POA Present on admission
PPI Producer price index
PPS Prospective payment system
PRM Provider Reimbursement Manual
ProPAC Prospective Payment Assessment
Commission
PRRB Provider Reimbursement Review
Board
PRTFs Psychiatric residential treatment
facilities
PSF Provider-Specific File
PSI Patient safety indicator
PS&R Provider Statistical and
Reimbursement [System]
PQRS Physician Quality Reporting System
QIG Quality Improvement Group [CMS]
QRDA Quality Reporting Data Architecture
RFA Regulatory Flexibility Act, Public Law
96–354
RHC Rural health clinic
RHQDAPU Reporting hospital quality data
for annual payment update
RNHCI Religious nonmedical health care
institution
RPL Rehabilitation psychiatric long-term
care (hospital)
RRC Rural referral center
RSMR Risk-standardized mortality rate
RSRR Risk-standard readmission rate
RTI Research Triangle Institute,
International
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RUCAs Rural-urban commuting area codes
RY Rate year
SAF Standard Analytic File
SCH Sole community hospital
SCHIP State Child Health Insurance
Program
SCIP Surgical Care Improvement Project
SFY State fiscal year
SGR Sustainable Growth Rate
SIC Standard Industrial Classification
SNF Skilled nursing facility
SOCs Standard occupational classifications
SOM State Operations Manual
SSI Surgical site infection
SSI Supplemental Security Income
SSO Short-stay outlier
SUD Substance use disorder
TEFRA Tax Equity and Fiscal
Responsibility Act of 1982, Public Law 97–
248
TEP Technical expert panel
THA/TKA Total hip arthroplasty/Total
knee arthroplasty
TMA TMA [Transitional Medical
Assistance], Abstinence Education, and QI
[Qualifying Individuals] Programs
Extension Act of 2007, Public Law 110–90
TPS Total Performance Score
UHDDS Uniform hospital discharge data set
UMRA Unfunded Mandate Reform Act,
Public Law 104–4
VBP [Hospital] Value Based Purchasing
[Program]
VTE Venous thromboembolism
Table of Contents
I. Executive Summary and Background
A. Executive Summary
1. Purpose and Legal Authority
2. Summary of the Major Provisions
3. Summary of Costs and Benefits
B. Summary
1. Acute Care Hospital Inpatient
Prospective Payment System (IPPS)
2. Hospitals and Hospital Units Excluded
From the IPPS
3. Long-Term Care Hospital Prospective
Payment System (LTCH PPS)
4. Critical Access Hospitals (CAHs)
5. Payments for Graduate Medical
Education (GME)
C. Summary of Provisions of Recent
Legislation Discussed in This Proposed
Rule
1. Patient Protection and Affordable Care
Act (Pub. L. 111–148) and the Health
Care and Education Reconciliation Act of
2010 (Pub. L. 111–152)
2. American Taxpayer Relief Act of 2012
(Pub. L. 112–240)
3. Pathway for Sustainable Growth Rate
(SGR) Reform Act of 2013 (Pub. L. 113–
67)
4. Protecting Access to Medicare Act of
2014 (Pub. L. 113–93)
D. Summary of the Major Provisions of this
Proposed Rule
II. Proposed Changes to Medicare Severity
Diagnosis-Related Group (MS–DRG)
Classifications and Relative Weights
A. Background
B. MS–DRG Reclassifications
C. Adoption of the MS–DRGs in FY 2008
D. Proposed FY 2016 MS–DRG
Documentation and Coding Adjustment
1. Background on the Prospective MS–DRG
Documentation and Coding Adjustments
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for FY 2008 and FY 2009 Authorized by
Public Law 110–90
2. Adjustment to the Average Standardized
Amounts Required by Public Law 110–
90
a. Prospective Adjustment Required by
Section 7(b)(1)(A) of Public Law 110–90
b. Recoupment or Repayment Adjustments
in FYs 2010 Through 2012 Required by
Section 7(b)(1)(B) Public Law 110–90
3. Retrospective Evaluation of FY 2008 and
FY 2009 Claims Data
4. Prospective Adjustments for FY 2008
and FY 2009 Authorized by Section
7(b)(1)(A) of Public Law 110–90
5. Recoupment or Repayment Adjustment
Authorized by Section 7(b)(1)(B) of
Public Law 110–90
6. Proposed Recoupment or Repayment
Adjustment Authorized by Section 631
of the American Taxpayer Relief Act of
2012 (ATRA)
E. Refinement of the MS–DRG Relative
Weight Calculation
1. Background
2. Discussion for FY 2016 and Request for
Comments on Nonstandard Cost Center
Codes
F. Proposed Adjustment to MS–DRGs for
Preventable Hospital-Acquired
Conditions (HACs), Including Infections,
for FY 2016
1. Background
2. HAC Selection
3. Present on Admission (POA) Indicator
Reporting
4. HACs and POA Reporting in Preparation
for Transition to ICD–10–CM and ICD–
10–PCS
5. Proposed Changes to the HAC Program
for FY 2016
6. RTI Program Evaluation
7. RTI Report on Evidence-Based
Guidelines
G. Proposed Changes to Specific MS–DRG
Classifications
1. Discussion of Changes to Coding System
and Basis for MS–DRG Updates
a. Conversion of MS–DRGs to the
International Classification of Diseases,
10th Edition (ICD–10)
b. Basis for Proposed FY 2016 MS–DRG
Updates
2. MDC 1 (Diseases and Disorders of the
Nervous System): Endovascular
Embolization (Coiling) Procedures
3. MDC 5 (Diseases and Disorders of the
Circulatory System)
a. Adding Severity Levels to MS–DRGs 245
Through 251
b. Percutaneous Intracardiac Procedures
c. Zilver® PTX Drug-Eluting Peripheral
Stent (ZPTX®)
d. Percutaneous Mitral Valve Repair
System—Proposed Revision of ICD–10–
PCS Version 32 Logic
e. Major Cardiovascular Procedures:
Zenith® Fenestrated Abdominal Aortic
Aneurysm (AAA) Endovascular Graft
4. MDC 8 (Diseases and Disorders of the
Musculoskeletal System and Connective
Tissue)
a. Revision of Hip or Knee Replacement:
Proposed Revision of ICD–10 Version 32
Logic
b. Spinal Fusion
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5. MDC 14 (Pregnancy, Childbirth and the
Puerperium): MS–DRG 775 (Vaginal
Delivery With Complicating Diagnosis)
6. MDC 21 (Injuries, Poisoning and Toxic
Effects of Drugs): CroFab Antivenin Drug
7. MDC 22 (Burns): Additional Severity of
Illness Level for MS–DRG 927 (Extensive
Burns or Full Thickness Burns With
Mechanical Ventilation 96 + Hours With
Skin Graft)
8. Proposed Medicare Code Editor (MCE)
Changes
9. Proposed Changes to Surgical
Hierarchies
10. Proposed Changes to the MS–DRG
Diagnosis Codes for FY 2016
a. Major Complications or Comorbidities
(MCCs) and Complications or
Comorbidities (CCs) Severity Levels for
FY 2016
b. Coronary Atherosclerosis Due to
Calcified Coronary Lesion
c. Hydronephrosis
11. Proposed Complications or
Comorbidity (CC) Exclusions List for FY
2016
a. Background
b. Proposed CC Exclusions List for FY 2016
12. Review of Procedure Codes in MS–
DRGs 981 Through 983, 984 Through
986, and 987 Through 989
a. Moving Procedure Codes From MS–
DRGs 981 Through 983 or MS–DRGs 987
Through 989 Into MDCs
b. Reassignment of Procedures Among MS–
DRGs 981 Through 983, 984 through 986,
and 987 Through 989
c. Adding Diagnosis or Procedure Codes to
MDCs
13. Proposed Changes to the ICD–9–CM
Coding System in FY 2016
a. ICD–10 Coordination and Maintenance
Committee
b. Code Freeze
14. Other Proposed Policy Change:
Recalled/Replaced Devices
H. Recalibration of the Proposed FY 2016
MS–DRG Relative Weights
1. Data Sources for Developing the
Proposed Relative Weights
2. Methodology for Calculation of the
Proposed Relative Weights
3. Development of Proposed National
Average CCRs
4. Solicitation of Public Comments on
Expanding the Bundled Payments for
Care Improvement (BPCI) Initiative
a. Background
b. Considerations for Potential Model
Expansion
I. Proposed Add-On Payments for New
Services and Technologies
1. Background
2. Public Input Before Publication of a
Notice of Proposed Rulemaking on AddOn Payments
3. Implementation of ICD–10–PCS Section
‘‘X’’ Codes for Certain New Medical
Services and Technologies for FY 2016
4. Proposed FY 2016 Status of
Technologies Approved for FY 2015
Add-On Payments
a. Glucarpidase (Voraxaze®)
b. Zenith® Fenestrated Abdominal Aortic
Aneurysm (AAA) Endovascular Graft
c. KcentraTM
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d. Argus® II Retinal Prosthesis System
e. Zilver®PTX® Drug-Eluting Peripheral
Stent
f. CardioMEMSTM HF (Heart Failure)
Monitoring System
g. MitraClip® System
h. Responsive Neurostimulator (RNS®
System)
5. FY 2016 Applications for New
Technology Add-On Payments
a. Angel Medical Guardian® Ischemia
Monitoring Device
b. Blinatumomab (BLINCYTOTM)
c. Ceftazidime Avibactam (AVYCAZ)
d. DIAMONDBACK® 360 Coronary Orbital
Atherectomy System
e. CRESEMBA® (Isavuconazonium)
f. Idarucizumab
g. LUTONIX® Drug Coated Balloon (DCB)
Percutaneous Transluminal Angioplasty
(PTA) and IN.PACTTMAdmiralTM
Pacliaxel Coated Percutaneous
Transluminal Angioplasty (PTA) Balloon
Catheter
h. VERASENSETM Knee Balancer System
(VKS)
i. WATCHMAN® Left Atrial Appendage
Closure Technology
III. Proposed Changes to the Hospital Wage
Index for Acute Care Hospitals
A. Background
1. Legislative Authority
2. Core-Based Statistical Areas (CBSAs) for
the Hospital Wage Index
B. Worksheet S–3 Wage Data for the
Proposed FY 2016 Wage Index
1. Included Categories of Costs
2. Excluded Categories of Costs
3. Use of Wage Index Data by Suppliers
and Providers Other Than Acute Care
Hospitals Under the IPPS
C. Verification of Worksheet S–3 Wage
Data
D. Method for Computing the Proposed FY
2016 Unadjusted Wage Index
E. Proposed Occupational Mix Adjustment
to the Proposed FY 2016 Wage Index
1. Development of Data for the Proposed
FY 2016 Occupational Mix Adjustment
Based on the 2013 Medicare Wage Index
Occupational Mix Survey
2. New 2013 Occupational Mix Survey
Data for the Proposed FY 2016 Wage
Index
3. Calculation of the Proposed
Occupational Mix Adjustment for FY
2016
F. Analysis and Implementation of the
Proposed Occupational Mix Adjustment
and the Proposed FY 2016 Occupational
Mix Adjusted Wage Index
G. Transitional Wage Indexes
1. Background
2. Transition for Hospitals in Urban Areas
That Became Rural
3. Transition for Hospitals Deemed Urban
Under Section 1886(d)(8)(B) of the Act
Where the Urban Area Became Rural
Under the New OMB Delineations
4. Expiring Transition for Hospitals That
Experience a Decrease in Wage Index
under the New OMB Delineations
5. Budget Neutrality
H. Proposed Application of the Rural,
Imputed, and Frontier Floors
1. Proposed Rural Floor
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2. Proposed Imputed Floor for FY 2016
3. Proposed State Frontier Floor
I. Proposed FY 2016 Wage Index Tables
J. Revisions to the Wage Index Based on
Hospital Redesignations and
Reclassifications
1. General Policies and Effects of
Reclassification and Redesignation
2. FY 2016 MGCRB Reclassifications and
Redesignation Issues
a. FY 2016 Reclassification Requests and
Approvals
b. Applications for Reclassifications for FY
2017
3. Redesignations of Hospitals Under
Section 1886(d)(8)(B) of the Act (Lugar)
4. Waiving Lugar Redesignation for the
Out-Migration Adjustment
K. Proposed Out-Migration Adjustment
Based on Commuting Patterns of
Hospital Employees
1. Background
2. New Data Source for the Proposed FY
2016 Out-Migration Adjustment
3. Proposed FY 2016 Out-Migration
Adjustment
4. Use of Out-Migration Data Applied for
FY 2014 or FY 2015 for 3 Years
L. Process for Requests for Wage Index
Data Corrections
M. Labor-Related Share for the Proposed
FY 2016 Wage Index
N. Proposed Changes to 3-Year Average for
the FY 2017 Wage Index Pension Costs
and Proposed Change to Wage Index
Timeline Regarding Pension Costs for FY
2017 and Subsequent Years
O. Clarification of Allocation of Pension
Costs for the Wage Index
IV. Other Decisions and Proposed Changes to
the IPPS for Operating Costs and Indirect
Medical Education (IME) Costs
A. Proposed Changes in the Inpatient
Hospital Updates for FY 2016
(§§ 412.64(d) and 412.211(c))
1. Proposed FY 2016 Inpatient Hospital
Update
2. Proposed FY 2016 Puerto Rico Hospital
Update
B. Rural Referral Centers (RRCs): Proposed
Annual Updates to Case-Mix Index (CMI)
and Discharge Criteria (§ 412.96)
1. Case-Mix Index (CMI)
2. Discharges
C. Indirect Medical Education (IME)
Payment Adjustment for FY 2016
(§ 412.105)
D. Proposed FY 2016 Payment Adjustment
for Medicare Disproportionate Share
Hospitals (DSHs) (§ 412.106)
1. Background
2. Impact on Medicare DSH Payment
Adjustment of the Continued
Implementation of New OMB Labor
Market Area Delineations
3. Payment Adjustment Methodology for
Medicare Disproportionate Share
Hospitals (DSHs) Under Section 3133 of
the Affordable Care Act
a. General Discussion
b. Eligibility for Empirically Justified
Medicare DSH Payments and
Uncompensated Care Payments
c. Empirically Justified Medicare DSH
Payments
d. Uncompensated Care Payments
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E. Hospital Readmissions Reduction
Program: Proposed Changes for FY 2016
Through FY 2017 (§§ 412.150 Through
412.154)
1. Statutory Basis for the Hospital
Readmissions Reduction Program
2. Regulatory Background
3. Overview of Proposed Policies Changes
for the FY 2016 and FY 2017 Hospital
Readmissions Reduction Program
4. Proposed Refinement of Hospital 30Day, All Cause, Risk-Standardized
Readmission Rate (RSSR) Following
Pneumonia Hospitalization Measure
Cohort (NQF #0506) for FY 2017
Payment Determination and Subsequent
Years
a. Background
b. Overview of Measure Cohort Change
c. Risk Adjustment
d. Anticipated Effect of Refinement of
Hospital 30-Day, All-Cause, RiskStandardized Readmission Rate (RSSR)
Following Pneumonia Hospitalization
Measure (NQF #0506) Cohort
e. Calculating the Excess Readmissions
Ratio
5. Maintenance of Technical Specifications
for Quality Measures
6. Floor Adjustment Factor for FY 2016
(§ 412.154(c)(2))
7. Proposed Applicable Period for FY 2016
8. Proposed Calculation of Aggregate
Payments for Excess Readmissions for
FY 2016
a. Background
b. Proposed Calculation of Aggregate
Payments for Excess Readmissions for
FY 2016
9. Proposed Extraordinary Circumstances
Exception Policy for the Hospital
Readmissions Reduction Program
Beginning FY 2016 and for Subsequent
Years
a. Background
b. Requests for an Extraordinary
Circumstances Exception
F. Hospital Value-Based Purchasing (VBP)
Program: Proposed Policy Changes for
the FY 2018 Program Year and
Subsequent Years
1. Background
a. Statutory Background and Overview of
Past Program Years
b. FY 2016 Program Year Payment Details
2. Proposed Retention, Removal,
Expansion, and Updating of Quality
Measures for FY 2018 Program Year
a. Retention of Previously Adopted
Hospital VBP Program Measures for the
FY 2018 Program Year
b. Proposed Removal of Two Measures
c. Proposed New Measure for the FY 2018
Program Year: 3-Item Care Transition
Measure (CTM–3) (NQF #0228)
d. Proposed Removal of Clinical Care—
Process Subdomain for the FY 2018
Program Year and Subsequent Years
e. NHSN Measures Standard Population
Data
f. Summary of Previously Adopted and
Newly Proposed Measures for the FY
2018 Program Year
3. Previously Adopted and Newly
Proposed Measures for the FY 2019, FY
2021, and Subsequent Program Years
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a. Intent To Propose in Future Rulemaking
To Include Selected Ward (NonIntensive Care Unit (ICU)) Locations in
Certain NHSN Measures Beginning With
the FY 2019 Program Year
b. Proposed New Measure for the FY 2021
Program Year: Hospital 30-Day, AllCause, Risk-Standardized Mortality Rate
Following Chronic Obstructive
Pulmonary Disease (COPD)
Hospitalization (NQF #1893)
c. Summary of Previously Adopted and
Newly Proposed Measures for the FY
2019 and FY 2021 and Subsequent
Program Years
4. Possible Measure Topics for Future
Program Years
5. Previously Adopted and Newly
Proposed Baseline and Performance
Periods for the FY 2018 Program Year
a. Background
b. Proposed Baseline and Performance
Periods for the Patient and CaregiverCentered Experience of Care/Care
Coordination Domain for the FY 2018
Program Year
c. Proposed Baseline and Performance
Periods for NHSN Measures and PC–01
in the Safety Domain for the FY 2018
Program Year
d. Proposed Baseline and Performance
Periods for the Efficiency and Cost
Reduction Domain for the FY 2018
Program Year
e. Summary of Previously Finalized and
Newly Proposed Baseline and
Performance Periods for the FY 2018
Program Year
6. Previously Adopted and Newly
Proposed Baseline and Performance
Periods for Future Program Years
a. Previously Adopted Baseline and
Performance Periods for the FY 2019
Program
b. Proposed Baseline and Performance
Periods for the PSI–90 Measure in the
Safety Domain in the FY 2020 Program
Years
c. Proposed Baseline and Performance
Periods for the Clinical Care Domain for
the FY 2021 Program Year
7. Proposed Performance Standards for the
Hospital VBP Program
a. Background
b. Technical Updates
c. Proposed Performance Standards for the
FY 2018 Program Year
d. Previously Adopted Performance
Standards for Certain Measures for the
FY 2019 Program Year
e. Previously Adopted and Newly
Proposed Performance Standards for
Certain Measures for the FY 2020
Program Year
f. Proposed Performance Standards for
Certain Measures for the FY 2021
Program Year
8. Proposed FY 2018 Program Year Scoring
Methodology
a. Proposed Domain Weighting for the FY
2018 Program Year for Hospitals That
Receive a Score on All Domains
b. Proposed Domain Weighting for the FY
2018 Program Year for Hospitals
Receiving Scores on Fewer Than Four
Domains
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G. Proposed Changes to the HospitalAcquired Condition (HAC) Reduction
Program
1. Background
2. Statutory Basis for the HAC Reduction
Program
3. Overview of Previous HAC Reduction
Program Rulemaking
4. Implementation of the HAC Reduction
Program for FY 2016
5. Proposed Changes for Implementation of
the HAC Reduction Program for FY 2017
a. Proposed Applicable Time Period for the
FY 2017 HAC Reduction Program
b. Proposed Narrative Rule Used in
Calculation of the Domain 2 Score for the
FY 2017 HAC Reduction Program
c. Proposed Domain 1 and Domain 2
Weights for the FY 2017 HAC Reduction
Program
6. Proposed Measure Refinements for the
FY 2018 HAC Reduction Program
a. Proposal To Include Select Ward (NonIntensive Care Unit (ICU)) Locations in
Certain CDC NHSN Measures Beginning
in the FY 2018 Program Year
b. Update to CDC NHSN Measures
Standard Population Data
7. Maintenance of Technical Specifications
for Quality Measures
8. Proposed Extraordinary Circumstances
Exception Policy for the HAC Reduction
Program Beginning in FY 2016 and for
Subsequent Years
a. Background
b. Requests for an Extraordinary
Circumstances Exception
H. Proposed Elimination of Simplified Cost
Allocation Methodology
1. Background
2. Proposed Changes
I. Rural Community Hospital
Demonstration Program
1. Background
2. Proposed FY 2016 Budget Neutrality
Offset Amount
J. Proposed Changes to MS–DRGs Subject
to the Postacute Care Transfer Policy
(§ 412.4)
1. Background
2. Proposed Changes to the Postacute Care
Transfer MS–DRGs
K. Short Inpatient Hospital Stays
V. Proposed Changes to the IPPS for CapitalRelated Costs
A. Overview
B. Additional Provisions
1. Exception Payments
2. New Hospitals
3. Hospitals Located in Puerto Rico
C. Proposed Annual Update for FY 2016
VI. Proposed Changes for Hospitals Excluded
From the IPPS
VII. Proposed Changes to the Long-Term Care
Hospital Prospective Payment System
(LTCH PPS) for FY 2016
A. Background of the LTCH PPS
1. Legislative and Regulatory Authority
2. Criteria for Classification as an LTCH
a. Classification as an LTCH
b. Hospitals Excluded From the LTCH PPS
3. Limitation on Charges to Beneficiaries
4. Administrative Simplification
Compliance Act (ASCA) and Health
Insurance Portability and Accountability
Act (HIPAA) Compliance
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B. Proposed Application of Site Neutral
Payment Rate (Proposed New § 412.522)
1. Overview
2. Proposed Application of the Site Neutral
Payment Rate Under the LTCH PPS
3. Criteria for Exclusion From the Site
Neutral Payment Rate
a. Statutory Provisions
b. Proposed Implementation of Criterion
for a Principal Diagnosis Relating to a
Psychiatric Diagnosis or to Rehabilitation
c. Proposed Addition of Definition of
‘‘Subsection (d) Hospital’’ to LTCH
Regulations
d. Proposed Interpretation of ‘‘Immediately
Preceded’’ by a Subsection (d) Hospital
Discharge
e. Proposed Implementation of Intensive
Care Unit (ICU) Criterion
f. Proposed Implementation of the
Ventilator Criterion
4. Proposed Determination of the Site
Neutral Payment Rate (Proposed New
§ 412.522(c))
a. General
b. Proposed Blended Payment Rate for FY
2016 and FY 2017
c. Proposed LTCH PPS Standard Federal
Payment Rate
5. Proposed Application of Certain Exiting
LTCH PPS Payment Adjustments to
Payments Made Under the Site Neutral
Payment Rate
6. Proposals Relating to the LTCH
Discharge Payment Percentage
7. Additional LTCH PPS Policy
Considerations Related to the
Implementation of the Site Neutral
Payment Rate Required by Section
1206(a) of Public Law 113–67
a. MS–LTC–DRG Relative Payment
Weights
b. High-Cost Outliers
c. Limitation on Charges to Beneficiaries
C. Proposed Medicare Severity Long-Term
Care Diagnosis-Related Group (MS–LTC–
DRG) Classifications and Relative
Weights for FY 2016
1. Background
2. Patient Classifications into MS–LTC–
DRGs
a. Background
b. Proposed Changes to the MS–LTC–DRGs
for FY 2016
3. Development of the Proposed FY 2016
MS–LTC–DRG Relative Weights
a. General Overview of the Development of
the MS–LTC–DRG Relative Weights
b. Development of the Proposed MS–LTC–
DRG Relative Weights for FY 2016
c. Data
d. Hospital-Specific Relative Value (HSRV)
Methodology
e. Treatment of Severity Levels in
Developing the Proposed MS–LTC–DRG
Relative Weights
f. Proposed Low-Volume MS–LTC–DRGs
g. Steps for Determining the Proposed FY
2016 MS–LTC–DRG Relative Weights
D. Proposed Changes to the LTCH PPS
Standard Payment Rates for FY 2016
1. Overview of Development of the LTCH
PPS Standard Federal Payment Rates
2. Proposed FY 2016 LTCH PPS Annual
Market Basket Update
a. Overview
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b. Proposed Revision of Certain Market
Basket Updates as Required by the
Affordable Care Act
c. Proposed Adjustment to the Annual
Update to the LTCH PPS Standard
Federal Rate Under the Long-Term Care
Hospital Quality Reporting Program
(LTCH QRP)
d. Proposed Market Basket Under the
LTCH PPS for FY 2016
e. Proposed Annual Market Basket Update
for LTCHs for FY 2016
E. Moratoria on the Establishment of
LTCHs and LTCH Satellite Facilities and
on the Increase in Number of Beds in
Existing LTCHs and LTCH Satellite
Facilities
F. Proposed Changes to Average Length of
Stay Criterion Under Public Law 113–67
(§ 412.23)
VIII. Proposed Quality Data Reporting
Requirements for Specific Providers and
Suppliers for FY 2016
A. Hospital Inpatient Quality Reporting
(IQR) Program
1. Background
a. History of the Hospital IQR Program
b. Maintenance of Technical Specifications
for Quality Measures
c. Public Display of Quality Measures
2. Process for Retaining Previously
Adopted Hospital IQR Program Measures
for Subsequent Payment Determinations
3. Removal and Suspension of Hospital
IQR Program Measures
a. Considerations in Removing Quality
Measures From the Hospital IQR
Program
b. Proposed Removal of Hospital IQR
Program Measures for the FY 2018
Payment Determination and Subsequent
Years
4. Previously Adopted Hospital IQR
Program Measures for the FY 2017
Payment Determination and Subsequent
Years
a. Background
b. NHSN Measures Standard Population
Data
5. Expansion and Updating of Quality
Measures
6. Proposed Refinements of Existing
Measures in the Hospital IQR Program
a. Proposed Refinement of Hospital 30-Day,
All-Cause, Risk-Standardized Mortality
Rate (RSMR) Following Pneumonia
Hospitalization (NQF #0468) Measure
Cohort
b. Proposed Refinement of Hospital 30Day, All-Cause, Risk-Standardized
Readmission Rate (RSRR) Following
Pneumonia Hospitalization (NQF #0468)
Measure Cohort
7. Proposed Additional Hospital IQR
Program Measures for the FY 2018
Payment Determination and Subsequent
Years
a. Hospital Survey on Patient Safety
Culture
b. Clinical Episode-Based Payment
Measures
c. Hospital-Level, Risk-Standardized
Payment Associated With a 90-Day
Episode-of-Care for Elective Primary
Total Hip Arthroplasty (THA) and/or
Total Knee Arthroplasty (TKA)
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d. Excess Days in Acute Care After
Hospitalization for Acute Myocardial
Infarction
e. Excess Days in Acute Care After
Hospitalization for Heart Failure
f. Summary of Previously Adopted and
Proposed Hospital IQR Program Measure
Set for the FY 2018 Payment
Determination and Subsequent Years
8. Electronic Clinical Quality Measures
a. Previously Adopted Voluntarily
Reported Electronic Clinical Quality
Measures for the FY 2017 Payment
Determination
b. Clarification of the Venous
Thromboembolism (VTE) Prophylaxis
(STK–01) Measure (NQF #0434)
c. Proposed Requirements for Hospitals To
Report Electronic Clinical Quality
Measures for the FY 2018 Payment
Determination and Subsequent Years
9. Future Considerations for Electronically
Specified Measures: Consideration To
Implement a New Type of Measure That
Utilizes Core Clinical Data Elements
a. Background
b. Overview of Core Clinical Data Elements
c. Core Clinical Data Elements
Development
d. Core Clinical Data Elements Feasibility
Testing Using Readmission and
Mortality Models
e. Use of Core Clinical Data Elements in
Hospital Quality Measures for the
Hospital IQR Program
f. Content Exchange Standard
Considerations for Core Clinical Data
Elements
10. Form, Manner, and Timing of Quality
Data Submission
a. Background
b. Procedural Requirements for the FY
2018 Payment Determination and
Subsequent Years
c. Data Submission Requirements for
Chart-Abstracted Measures
d. Alignment of the Medicare EHR
Incentive Program Reporting for Eligible
Hospitals and CAHs With the Hospital
IQR Program
e. Sampling and Case Thresholds for the
FY 2018 Payment Determination and
Subsequent Years
f. HCAHPS Requirements for the FY 2018
Payment Determination and Subsequent
Years
g. Data Submission Requirements for
Structural Measures for the FY 2018
Payment Determination and Subsequent
Years
h. Data Submission and Reporting
Requirements for Healthcare-Associated
Infection (HAI) Measures Reported via
NHSN
11. Proposed Modifications to the Existing
Processes for Validation of Hospital IQR
Program Data
a. Background
b. Proposed Modifications to the Existing
Processes for Validation of ChartAbstracted Hospital IQR Program Data
12. Data Accuracy and Completeness
Acknowledgement Requirements for the
FY 2018 Payment Determination and
Subsequent Years
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13. Public Display Requirements for the FY
2018 Payment Determination and
Subsequent Years
14. Reconsideration and Appeal
Procedures for the FY 2018 Payment
Determination and Subsequent Years
15. Hospital IQR Program Extraordinary
Circumstances Extensions or Exemptions
B. PPS-Exempt Cancer Hospital Quality
Reporting (PCHQR) Program
1. Statutory Authority
2. Proposed Removal of Six Surgical Care
Improvement Project (SCIP) Measures
From the PCHQR Program Beginning
With Fourth Quarter (Q4) 2015
Discharges and for Subsequent Years
3. Proposed New Quality Measures
Beginning With the FY 2018 Program
a. Considerations in the Selection of
Quality Measures
b. Summary of Proposed New Measures
c. CDC NHSN Facility-Wide Inpatient
Hospital-Onset Clostridium difficile (C.
difficile) Infection (CDI) Outcome
Measure (NQF #1717)
d. CDC NHSN Facility-Wide Inpatient
Hospital-Onset Methicillin-Resistant
Staphylococcus Aureus (MSRA)
Bacteremia Outcome Measure (NQF
#1716)
e. CDC NHSN Influenza Vaccination
Coverage Among Healthcare Personnel
(HCP) Measure (NQF #0431) (CDC NHSN
HCP Measure)
4. Possible New Quality Measure Topics
for Future Years
5. Maintenance of Technical Specifications
for Quality Measures
6. Public Display Requirements
a. Background
b. Proposed Additional Public Display
Requirements
7. Form, Manner, and Timing of Data
Submission
a. Background
b. Reporting Requirements for the
Proposed New Measures: CDC NHSN
CDI (NQF #1717), CDC NHSN MRSA
(NQF #1716), and CDC NHSN HCP (NQF
#0431) Measures
C. Long-Term Care Hospital Quality
Reporting Program (LTCH QRP)
1. Background and Statutory Authority
2. General Considerations Used for
Selection, Resource Use, and Other
Quality Measures for the LTCH QRP
3. Policy for Retention of LTCH QRP
Measures Adopted for Previous Payment
Determinations
4. Policy for Adopting Changes to LTCH
QRP Measures
5. Previously Adopted Quality Measures
a. Previously Adopted Quality Measures
for the FY 2015 and FY 2016 Payment
Determinations and Subsequent Years
b. Previously Adopted Quality Measures
for the FY 2017 and FY 2018 Payment
Determinations and Subsequent Years
6. Previously Adopted LTCH QRP Quality
Measures for the FY 2018 Payment
Determinations and Subsequent Years
a. Proposal To Reflect NQF Endorsement:
All-Cause Unplanned Readmission
Measure for 30 Days Post-Discharge
From LTCHs (NQF #2512)
b. Proposal To Address the IMPACT Act of
2014: Quality Measure Addressing the
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Domain of Skin Integrity and Changes in
Skin Integrity: Percent of Residents or
Patients With Pressure Ulcers That Are
New or Worsened (Short Stay) (NQF
#0678)
c. Proposal To Address the IMPACT Act of
2014: Quality Measure Addressing the
Domain of Incidence of Major Falls:
Application of Percent of Residents
Experiencing One or More Falls With
Major Injury (Long Stay) (NQF #0674)
d. Proposal To Address the IMPACT Act of
2014: Quality Measure Addressing the
Domain of Functional Status, Cognitive
Function, and Changes in Function and
Cognitive Function: Application of
Percent of LTCH Patients With an
Admission and Discharge Functional
Assessment and a Care Plan That
Addresses Function (NQF #2631; Under
NQF Review)
7. LTCH QRP Quality Measures for the FY
2019 Payment Determination and
Subsequent Years
8. LTCH QRP Quality Measures and
Concepts Under Consideration for Future
Years
9. Form, Manner, and Timing of Quality
Data Submission for the FY 2016
Payment Determinations and Subsequent
Years
a. Background
b. Proposed Timing for New LTCHs To
Begin Reporting Data to CMS for the FY
2017 Payment Determinations and
Subsequent Years
c. Proposed Revisions to Previously
Adopted Data Submission Timelines
Under the LTCH QRP for the FY 2017
and FY 2018 Payment Determinations
and Subsequent Years and Proposed
Data Collection and Data Submission
Timelines for Quality Measures
Proposed in This Proposed Rule
10. Previously Adopted LTCH QRP Data
Completion Thresholds for the FY 2016
Payment Determination and Subsequent
Years
11. Future LTCH QRP Data Validation
Process
12. Proposed Public Display of Quality
Measure Data for the LTCH QRP
13. Previously Adopted and Proposed
LTCH QRP Reconsideration and Appeals
Procedures for the FY 2017 Payment
Determination and Subsequent Years
14. Previously Adopted and Proposed
LTCH QRP Submission Exception and
Extension Requirements for the FY 2017
Payment Determination and Subsequent
Years
D. Clinical Quality Measurement for
Eligible Hospitals and Critical Access
Hospitals Participating in the EHR
Incentive Programs in 2016
1. Background
2. CQM Reporting for the Medicare and
Medicaid EHR Incentive Programs in
2016
a. Background
b. Proposed CQM Reporting Period for the
Medicare and Medicaid EHR Incentive
Programs for CY 2016
c. CQM Form and Method for the Medicare
EHR Incentive Programs for 2016
3. Certified EHR Technology for CQMs for
the EHR Incentive Programs in 2016
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a. Edition of Certified EHR Technology
Requirements for 2016
b. ‘‘CQM—Report’’ Certification Criterion
in ONC’s 2015 Edition Proposed Rule
4. CQM Development and Certification
Cycle
IX. MedPAC Recommendations
X. Other Required Information
A. Requests for Data From the Public
B. Collection of Information Requirements
1. Statutory Requirement for Solicitation of
Comments
2. ICRs for Add-On Payments for New
Services and Technologies
3. ICRs for the Proposed Occupational Mix
Adjustment to the Proposed FY 2016
Wage Index (Hospital Wage Index
Occupational Mix Survey)
4. Hospital Applications for Geographic
Reclassifications by the MGCRB
5. ICRs for the Hospital Inpatient Quality
Reporting (IQR) Program
6. ICRs for PPS-Exempt Cancer Hospital
Quality Reporting (PCHQR) Program
7. ICRs for Hospital Value-Based
Purchasing (VBP) Program
8. ICRs for the Long-Term Care Hospital
Quality Reporting Program (LTCHQR)
C. Response to Comments
Regulation Text
Addendum—Proposed Schedule of
Standardized Amounts, Update Factors,
and Rate-of-Increase Percentages
Effective With Cost Reporting Periods
Beginning on or After October 1, 2015
and Proposed Payment Rates for LTCHs
Effective With Discharges Occurring on
or After October 1, 2015
I. Summary and Background
II. Proposed Changes to the Prospective
Payment Rates for Hospital Inpatient
Operating Costs for Acute Care Hospitals
for FY 2016
A. Calculation of the Adjusted
Standardized Amount
B. Adjustments for Area Wage Levels and
Cost-of-Living
C. Proposed MS–DRG Relative Weights
D. Calculation of the Prospective Payment
Rates
III. Proposed Changes to Payment Rates for
Acute Care Hospital Inpatient CapitalRelated Costs for FY 2016
A. Determination of Federal Hospital
Inpatient Capital-Related Prospective
Payment Rate Update
B. Calculation of the Proposed Inpatient
Capital-Related Prospective Payments for
FY 2016
C. Capital Input Price Index
IV. Proposed Changes to Payment Rates for
Excluded Hospitals: Rate-of-Increase
Percentages for FY 2016
V. Proposed Updates to the Payment Rates
for the LTCH PPS for FY 2016
A. Proposed LTCH PPS Standard Federal
Rate for FY 2016
1. Background
2. Development of the Proposed FY 2016
LTCH PPS Standard Federal Rate
B. Proposed Adjustment for Area Wage
Levels Under the LTCH PPS Standard
Federal Payment Rate for FY 2016
1. Background
2. Proposed Geographic Classifications
(Labor Market Areas) for the LTCH PPS
Standard Federal Payment Rate
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3. Proposed Labor-Related Share for the
LTCH PPS Standard Federal Payment
Rate
4. Proposed Wage Index for FY 2016 for the
LTCH PPS Standard Federal Payment
Rate
5. Proposed Budget Neutrality Adjustment
for Proposed Changes to the LTCH PPS
Standard Federal Payment Rate Area
Wage Level Adjustment
C. Proposed LTCH PPS Cost-of-Living
Adjustment (COLA) for LTCHs Located
in Alaska and Hawaii
D. Proposed Adjustment for LTCH PPS
High-Cost Outlier (HCO) Cases
1. Overview
2. Determining Proposed LTCH CCRs
Under the LTCH PPS
3. Proposed High-Cost Outlier Payments
for LTCH PPS Standard Federal Payment
Rate Cases
4. Proposed High-Cost Outlier Payments
for Site Neutral Payment Rate Cases
E. Proposed Update to the IPPS
Comparable/Equivalent Amounts To
Reflect the Statutory Changes to the IPPS
DSH Payment Adjustment Methodology
F. Computing the Proposed Adjusted LTCH
PPS Federal Prospective Payments for
FY 2016
VI. Tables Referenced in This Proposed Rule
and Available Through the Internet on
the CMS Web site
Appendix A—Economic Analyses
I. Regulatory Impact Analysis
A. Introduction
B. Need
C. Objectives of the IPPS
D. Limitations of Our Analysis
E. Hospitals Included in and Excluded
From the IPPS
F. Effects on Hospitals and Hospital Units
Excluded From the IPPS
G. Quantitative Effects of the Proposed
Policy Changes Under the IPPS for
Operating Costs
1. Basis and Methodology of Estimates
2. Analysis of Table I
3. Impact Analysis of Table II
H. Effects of Other Proposed Policy
Changes
1. Effects of Proposed Policy on MS–DRGs
for Preventable HACs, Including
Infections
2. Effects of Proposed Policy Relating to
New Medical Service and Technology
Add-On Payments
3. Effects of Proposed Changes in Medicare
DSH Payments for FY 2016
4. Effects of Proposed Reductions Under
the Hospital Readmissions Reduction
Program
5. Effects of Proposed Changes Under the
FY 2016 Hospital Value-Based
Purchasing (VBP) Program
6. Effects of Proposed Changes to the HAC
Reduction Program for FY 2016
7. Effects of Proposed Elimination of the
Simplified Cost Allocation Methodology
8. Effects of Implementation of Rural
Community Hospital Demonstration
Program
9. Effects of Proposed Changes to List of
MS–DRGs Subject to Postacute Care
Transfer and DRG Special Pay Policy
I. Effects of Proposed Changes in the
Capital IPPS
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1. General Considerations
2. Results
J. Effects of Proposed Payment Rate
Changes and Proposed Policy Changes
Under the LTCH PPS
1. Introduction and General Considerations
2. Impact on Rural Hospitals
3. Anticipated Effects of Proposed LTCH
PPS Payment Rate Changes and
Proposed Policy Changes
4. Effect on the Medicare Program
5. Effect on Medicare Beneficiaries
K. Effects of Proposed Requirements for
Hospital Inpatient Quality Reporting
(IQR) Program
L. Effects of Proposed Requirements for the
PPS-Exempt Cancer Hospital Quality
Reporting (PCHQR) Program for FY 2016
M. Effects of Proposed Requirements for
the LTCH Quality Reporting Program
(LTCH QRP) for FY 2016 Through FY
2020
N. Effects of Proposed Changes to Clinical
Quality Measurement for Eligible
Hospitals and Critical Access Hospitals
Participating in the EHR Incentive
Programs in 2016
II. Alternatives Considered
III. Overall Conclusion
A. Acute Care Hospitals
B. LTCHs
IV. Accounting Statements and Tables
A. Acute Care Hospitals
B. LTCHs
V. Regulatory Flexibility Act (RFA) Analysis
VI. Impact on Small Rural Hospitals
VII. Unfunded Mandate Reform Act (UMRA)
Analysis
VIII. Executive Order 12866
Appendix B: Recommendation of Update
Factors for Operating Cost Rates of
Payment for Inpatient Hospital Services
I. Background
II. Proposed Inpatient Hospital Updates for
FY 2016
A. Proposed FY 2016 Inpatient Hospital
Update
B. Proposed Update for SCHs for FY 2016
C. Proposed FY 2016 Puerto Rico Hospital
Update
D. Proposed Update for Hospitals Excluded
From the IPPS for FY 2016
E. Proposed Update for LTCHs for FY 2016
III. Secretary’s Recommendation
IV. MedPAC Recommendation for Assessing
Payment Adequacy and Updating
Payments in Traditional Medicare
I. Executive Summary and Background
A. Executive Summary
1. Purpose and Legal Authority
This proposed rule would make
payment and policy changes under the
Medicare inpatient prospective payment
systems (IPPS) for operating and capitalrelated costs of acute care hospitals as
well as for certain hospitals and hospital
units excluded from the IPPS. In
addition, it would make payment and
policy changes for inpatient hospital
services provided by long-term care
hospitals (LTCHs) under the long-term
care hospital prospective payment
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system (LTCH PPS). It also would make
policy changes to programs associated
with Medicare IPPS hospitals, IPPSexcluded hospitals, and LTCHs.
Under various statutory authorities,
we are proposing to make changes to the
Medicare IPPS, to the LTCH PPS, and to
other related payment methodologies
and programs for FY 2016 and
subsequent fiscal years. These statutory
authorities include, but are not limited
to, the following:
• Section 1886(d) of the Social
Security Act (the Act), which sets forth
a system of payment for the operating
costs of acute care hospital inpatient
stays under Medicare Part A (Hospital
Insurance) based on prospectively set
rates. Section 1886(g) of the Act requires
that, instead of paying for capital-related
costs of inpatient hospital services on a
reasonable cost basis, the Secretary use
a prospective payment system (PPS).
• Section 1886(d)(1)(B) of the Act,
which specifies that certain hospitals
and hospital units are excluded from the
IPPS. These hospitals and units are:
Rehabilitation hospitals and units;
LTCHs; psychiatric hospitals and units;
children’s hospitals; cancer hospitals;
and short-term acute care hospitals
located in the Virgin Islands, Guam, the
Northern Mariana Islands, and
American Samoa. Religious nonmedical
health care institutions (RNHCIs) are
also excluded from the IPPS.
• Sections 123(a) and (c) of Public
Law 106–113 and section 307(b)(1) of
Public Law 106–554 (as codified under
section 1886(m)(1) of the Act), which
provide for the development and
implementation of a prospective
payment system for payment for
inpatient hospital services of long-term
care hospitals (LTCHs) described in
section 1886(d)(1)(B)(iv) of the Act.
• Sections 1814(l), 1820, and 1834(g)
of the Act, which specify that payments
are made to critical access hospitals
(CAHs) (that is, rural hospitals or
facilities that meet certain statutory
requirements) for inpatient and
outpatient services and that these
payments are generally based on 101
percent of reasonable cost.
• Section 1866(k) of the Act, as added
by section 3005 of the Affordable Care
Act, which establishes a quality
reporting program for hospitals
described in section 1886(d)(1)(B)(v) of
the Act, referred to as ‘‘PPS-Exempt
Cancer Hospitals.’’
• Section 1886(d)(4)(D) of the Act,
which addresses certain hospitalacquired conditions (HACs), including
infections. Section 1886(d)(4)(D) of the
Act specifies that, by October 1, 2007,
the Secretary was required to select, in
consultation with the Centers for
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Disease Control and Prevention (CDC),
at least two conditions that: (a) Are high
cost, high volume, or both; (b) are
assigned to a higher paying MS–DRG
when present as a secondary diagnosis
(that is, conditions under the MS–DRG
system that are complications or
comorbidities (CCs) or major
complications or comorbidities (MCCs);
and (c) could reasonably have been
prevented through the application of
evidence-based guidelines. Section
1886(d)(4)(D) of the Act also specifies
that the list of conditions may be
revised, again in consultation with CDC,
from time to time as long as the list
contains at least two conditions. Section
1886(d)(4)(D)(iii) of the Act requires that
hospitals, effective with discharges
occurring on or after October 1, 2007,
submit information on Medicare claims
specifying whether diagnoses were
present on admission (POA). Section
1886(d)(4)(D)(i) of the Act specifies that
effective for discharges occurring on or
after October 1, 2008, Medicare no
longer assigns an inpatient hospital
discharge to a higher paying MS–DRG if
a selected condition is not POA.
• Section 1886(a)(4) of the Act, which
specifies that costs of approved
educational activities are excluded from
the operating costs of inpatient hospital
services. Hospitals with approved
graduate medical education (GME)
programs are paid for the direct costs of
GME in accordance with section 1886(h)
of the Act. A payment for indirect
medical education (IME) is made under
section 1886(d)(5)(B) of the Act.
• Section 1886(b)(3)(B)(viii) of the
Act, which requires the Secretary to
reduce the applicable percentage
increase in payments to a subsection (d)
hospital for a fiscal year if the hospital
does not submit data on measures in a
form and manner, and at a time,
specified by the Secretary.
• Section 1886(o) of the Act, which
requires the Secretary to establish a
Hospital Value-Based Purchasing (VBP)
Program under which value-based
incentive payments are made in a fiscal
year to hospitals meeting performance
standards established for a performance
period for such fiscal year.
• Section 1886(p) of the Act, as added
by section 3008 of the Affordable Care
Act, which establishes an adjustment to
hospital payments for hospital-acquired
conditions (HACs), or a HospitalAcquired Condition (HAC) Reduction
Program, under which payments to
applicable hospitals are adjusted to
provide an incentive to reduce hospitalacquired conditions.
• Section 1886(q) of the Act, as added
by section 3025 of the Affordable Care
Act and amended by section 10309 of
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the Affordable Care Act, which
establishes the ‘‘Hospital Readmissions
Reduction Program’’ effective for
discharges from an ‘‘applicable
hospital’’ beginning on or after October
1, 2012, under which payments to those
hospitals under section 1886(d) of the
Act will be reduced to account for
certain excess readmissions.
• Section 1886(r) of the Act, as added
by section 3133 of the Affordable Care
Act, which provides for a reduction to
disproportionate share hospital
payments under section 1886(d)(5)(F) of
the Act and for a new uncompensated
care payment to eligible hospitals.
Specifically, section 1886(r) of the Act
now requires that, for fiscal year 2014
and each subsequent fiscal year,
subsection (d) hospitals that would
otherwise receive a disproportionate
share hospital payment made under
section 1886(d)(5)(F) of the Act will
receive two separate payments: (1) 25
percent of the amount they previously
would have received under section
1886(d)(5)(F) of the Act for DSH (‘‘the
empirically justified amount’’), and (2)
an additional payment for the DSH
hospital’s proportion of uncompensated
care, determined as the product of three
factors. These three factors are: (1) 75
percent of the payments that would
otherwise be made under section
1886(d)(5)(F) of the Act; (2) 1 minus the
percent change in the percent of
individuals under the age of 65 who are
uninsured (minus 0.1 percentage points
for FY 2014, and minus 0.2 percentage
points for FY 2015 through FY 2017);
and (3) a hospital’s uncompensated care
amount relative to the uncompensated
care amount of all DSH hospitals
expressed as a percentage.
• Section 1886(m)(6) of the Act, as
added by section 1206(a)(1) of the
Pathway for SGR Reform Act of 2013
(Pub. L. 113–67), which provided for the
establishment of patient criteria for
payment under the LTCH PPS for
implementation beginning in FY 2016.
• Section 1206(b)(1) of the Pathway
for SGR Reform Act of 2013, which
further amended section 114(c) of the
MMSEA, as amended by section 4302(a)
of the ARRA and sections 3106(c) and
10312(a) of the Affordable Care Act, by
retroactively reestablishing and
extending the statutory moratorium on
the full implementation of the 25percent threshold payment adjustment
policy under the LTCH PPS so that the
policy will be in effect for 9 years
(except for ‘‘grandfathered’’ hospitalwithin-hospitals (HwHs), which are
permanently exempt from this policy);
and section 1206(b)(2) (as amended by
section 112(b) of Pub. L. 113–93), which
together further amended section 114(d)
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of the MMSEA, as amended by section
4302(a) of the ARRA and sections
3106(c) and 10312(a) of the Affordable
Care Act to establish a new moratoria
(subject to certain defined exceptions)
on the development of new LTCHs and
LTCH satellite facilities and a new
moratorium on increases in the number
of beds in existing LTCHs and LTCH
satellite facilities beginning January 1,
2015 and ending on September 30,
2017; and section 1206(d), which
instructs the Secretary to evaluate
payments to LTCHs classified under
section 1886(b)(1)(C)(iv)(II) of the Act
and to adjust payment rates in FY 2015
or FY 2016 under the LTCH PPS, as
appropriate, based upon the evaluation
findings.
• Section 1886(m)(5)(D)(iv) of the
Act, as added by section 1206 (c) of the
Pathway for SGR Reform Act of 2013,
which provides for the establishment,
no later than October 1, 2015, of a
functional status quality measure under
the LTCH QRP for change in mobility
among inpatients requiring ventilator
support.
• Section 1899B of the Act, as added
by the Improving Medicare Post-Acute
Care Transformation Act of 2014 (the
IMPACT Act of 2014), which imposes
new data reporting requirements for
certain postacute care providers,
including LTCHs.
2. Summary of the Major Provisions
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a. MS–DRG Documentation and Coding
Adjustment
Section 631 of the American Taxpayer
Relief Act (ATRA, Pub. L. 112–240)
amended section 7(b)(1)(B) of Public
Law 110–90 to require the Secretary to
make a recoupment adjustment to the
standardized amount of Medicare
payments to acute care hospitals to
account for changes in MS–DRG
documentation and coding that do not
reflect real changes in case-mix, totaling
$11 billion over a 4-year period of FYs
2014, 2015, 2016, and 2017. This
adjustment represents the amount of the
increase in aggregate payments as a
result of not completing the prospective
adjustment authorized under section
7(b)(1)(A) of Public Law 110–90 until
FY 2013. Prior to the ATRA, this
amount could not have been recovered
under Public Law 110–90.
While our actuaries estimated that a
¥9.3 percent adjustment to the
standardized amount would be
necessary if CMS were to fully recover
the $11 billion recoupment required by
section 631 of the ATRA in one year, it
is often our practice to delay or phase
in rate adjustments over more than one
year, in order to moderate the effects on
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rates in any one year. Therefore,
consistent with the policies that we
have adopted in many similar cases, we
made a ¥0.8 percent recoupment
adjustment to the standardized amount
in FY 2014 and FY 2015. We are
proposing to make an additional ¥0.8
percent recoupment adjustment to the
standardized amount in FY 2016.
b. Reduction of Hospital Payments for
Excess Readmissions
We are proposing changes in policies
to the Hospital Readmissions Reduction
Program, which is established under
section 1886(q) of the Act, as added by
section 3025 of the Affordable Care Act.
The Hospital Readmissions Reduction
Program requires a reduction to a
hospital’s base operating DRG payment
to account for excess readmissions of
selected applicable conditions. For FYs
2013 and 2014, these conditions are
acute myocardial infarction, heart
failure, and pneumonia. For FY 2014,
we established additional exclusions to
the three existing readmission measures
(that is, the excess readmission ratio) to
account for additional planned
readmissions. We also established
additional readmissions measures,
chronic obstructive pulmonary disease
(COPD), and total hip arthroplasty and
total knee arthroplasty (THA/TKA), to
be used in the Hospital Readmissions
Reduction Program for FY 2015 and
future years. We expanded the
readmissions measures for FY 2017 and
future years by adding a measure of
patients readmitted following coronary
artery bypass graft (CABG) surgery.
In this proposed rule, we are
proposing a refinement to the
pneumonia readmissions measure,
which would expand the measure
cohort for the FY 2017 payment
determination and subsequent years. In
addition, we are proposing to adopt an
extraordinary circumstance exception
policy that would align with existing
extraordinary circumstance exception
policies for other IPPS quality reporting
and payment programs and would allow
hospitals that experience an
extraordinary circumstance (such as a
hurricane or flood) to request a waiver
for use of data from the affected time
period.
c. Hospital Value-Based Purchasing
(VBP) Program
Section 1886(o) of the Act requires the
Secretary to establish a Hospital VBP
Program under which value-based
incentive payments are made in a fiscal
year to hospitals based on their
performance on measures established
for a performance period for such fiscal
year.
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For FY 2016, we are proposing to
adopt one additional measure beginning
with the FY 2018 program year and one
measure beginning with the FY 2021
program year. We also are proposing to
remove two measures beginning with
the FY 2018 program year. In addition,
we are proposing to move one measure
to the Safety domain and to remove the
Clinical Care—Process subdomain and
rename the Clinical Care—Outcomes
subdomain as the Clinical Care domain.
Finally, we are signaling our intent to
propose in future rulemaking to expand
one measure and to update the standard
population data we use to calculate
several measures beginning with the FY
2019 program year.
d. Hospital-Acquired Condition (HAC)
Reduction Program
Section 1886(p) of the Act, as added
under section 3008(a) of the Affordable
Care Act, establishes an incentive to
hospitals to reduce the incidence of
hospital-acquired conditions by
requiring the Secretary to make an
adjustment to payments to applicable
hospitals effective for discharges
beginning on October 1, 2014 and for
subsequent program years. This 1percent payment reduction applies to a
hospital whose ranking is in the top
quartile (25 percent) of all applicable
hospitals, relative to the national
average, of conditions acquired during
the applicable period and on all of the
hospital’s discharges for the specified
fiscal year. The amount of payment
shall be equal to 99 percent of the
amount of payment that would
otherwise apply to such discharges
under section 1886(d) or 1814(b)(3) of
the Act, as applicable.
In this proposed rule, we are
proposing three changes to existing
Hospital-Acquired Condition Reduction
Program policies: (1) An expansion to
the population covered by the central
line-associated bloodstream infection
(CLABSI) and catheter-associated
urinary tract infection (CAUTI)
measures to include patients in select
nonintensive care unit sites within a
hospital; (2) an adjustment to the
relative contribution of each domain to
the Total HAC Score which is used to
determine if a hospital will receive the
payment adjustment; and (3) a policy
that would align with existing
extraordinary circumstance exception
policies for other IPPS quality reporting
and payment programs and would allow
hospitals to request a waiver for use of
data from the affected time period.
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e. DSH Payment Adjustment and
Additional Payment for Uncompensated
Care
Section 3133 of the Affordable Care
Act modified the Medicare
disproportionate share hospital (DSH)
payment methodology beginning in FY
2014. Under section 1886(r) of the Act,
which was added by section 3133 of the
Affordable Care Act, starting in FY
2014, DSHs will receive 25 percent of
the amount they previously would have
received under the current statutory
formula for Medicare DSH payments in
section 1886(d)(5)(F) of the Act. The
remaining amount, equal to 75 percent
of what otherwise would have been paid
as Medicare DSH payments, will be paid
as additional payments after the amount
is reduced for changes in the percentage
of individuals that are uninsured. Each
Medicare DSH hospital will receive an
additional payment based on its share of
the total amount of uncompensated care
for all Medicare DSH hospitals for a
given time period.
In this proposed rule, we are
proposing to update our estimates of the
three factors used to determine
uncompensated care payments for FY
2016. We are proposing to continue to
use the methodology we established in
FY 2015 to calculate the uncompensated
care payment amounts for merged
hospitals such that we combine
uncompensated care data for the
hospitals that have undergone a merger
in order to calculate their relative share
of uncompensated care. We also are
proposing a change to the time period
of the data used to calculate the
uncompensated care payment amounts
to be distributed.
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f. Proposed Changes to the LTCH PPS
Under the current LTCH PPS, all
discharges are paid under the LTCH PPS
standard Federal payment rate. In this
proposed rule, we are proposing to
implement section 1206 of the Pathways
for SGR Reform Act, which requires the
establishment of an alternative site
neutral payment rate for Medicare
inpatient discharges from an LTCH that
fail to meet certain statutory defined
criteria, beginning with LTCH
discharges occurring in cost reporting
periods beginning on or after October 1,
2015. We include proposals regarding
the application of the site neutral
payment rate and the criteria for
exclusion from the site neutral payment
rate, as well as proposals on a number
of methodological and implementation
issues, such as the criterion for a
principal diagnosis relating to a
psychiatric diagnosis or to
rehabilitation, the intensive care unit
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(ICU) criterion, the ventilator criterion,
the definition of ‘‘immediately
preceded’’ by a subsection (d) hospital
discharge, limitation on beneficiary
charges in the context of the new site
neutral payment rate, and the
transitional blended payment rate
methodology for FY 2016 and FY 2017.
In addition, we are proposing changes
to address certain statutory
requirements related to an LTCH’s
average length of stay criterion and
discharge payment percentage. We also
are providing technical clarifications
relating to our FY 2015 implementation
of the new statutory moratoria on the
establishment of new LTCHs and LTCH
satellite facilities (subject to certain
defined exceptions) and on bed
increases in existing LTCHs and LTCH
satellite facilities as well as proposing a
technical revision to the regulations to
more clearly reflect our established
policies.
g. Hospital Inpatient Quality Reporting
(IQR) Program
Under section 1886(b)(3)(B)(viii) of
the Act, hospitals are required to report
data on measures selected by the
Secretary for the Hospital IQR Program
in order to receive the full annual
percentage increase in payments. In past
years, we have established measures for
reporting data and the process for
submittal and validation of the data.
In this proposed rule, we are
proposing to update considerations for
measure removal and retention. In
addition, we are proposing to remove
nine measures for the FY 2018 payment
determination and subsequent years: Six
of these measures are ‘‘topped-out’’ and
two of the measures are suspended.
However, we are retaining the electronic
version of six of these measures. We
also are proposing to refine two
previously adopted measures as well as
for the FY 2018 payment determination
and subsequent years and add eight new
measures: Seven new claims-based
measures and one structural measure.
Further, for the FY 2018 payment
determination, we are proposing to
require hospitals to report 16 of the 28
electronic clinical quality measures
under the Hospital IQR Program that
align with the Medicare EHR Incentive
Program and span 3 different NQS
domains. We also are proposing to
require that hospitals submit two
quarters (Q3 and Q4) of data within 2
months following the last discharge date
of the quarter. We are proposing to
delay and footnote public reporting of
electronic clinical quality measure data
submitted by hospitals for the CY 2016/
FY 2018 payment determination.
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We are proposing to align the
reporting and submission timelines for
the electronic submission of clinical
quality measures for the Medicare EHR
Incentive Program for eligible hospitals
and critical access hospitals (CAHs)
with the reporting and submission
timelines for the Hospital IQR Program.
Lastly, ONC is proposing a 2015 Edition
certification criterion for ‘‘CQMs—
report’’ as part of the proposed 2015
Edition of certification criteria that
would require a certified Health IT
Module to enable a user to
electronically create a data file for
transmission of clinical quality
measurement data. This proposed
certification criterion would apply to
eligible professionals, eligible hospitals,
and CAHs.
h. Long-Term Care Quality Reporting
Program (LTCH QRP)
Section 3004(a) of the Affordable Care
Act amended section 1886(m)(5) of the
Act to require the Secretary to establish
the Long-Term Care Hospital Quality
Reporting Program (LTCH QRP). This
program applies to all hospitals certified
by Medicare as LTCHs. Beginning with
the FY 2014 payment determination and
subsequent years, the Secretary is
required to reduce any annual update to
the standard Federal rate for discharges
occurring during such fiscal year by 2
percentage points for any LTCH that
does not comply with the requirements
established by the Secretary.
The IMPACT Act of 2014 amended
the Act in ways that affect the LTCH
QRP. Specifically, section 2(a) of the
IMPACT Act of 2014 added section
1899B of the Act, and section 2(c)(3) of
the IMPACT Act of 2014 amended
section 1886(m)(5) of the Act. Under
section 1899B(a)(1) of the Act, the
Secretary must require post-acute care
(PAC) providers (defined in section
1899B(a)(2)(A) of the Act to include
HHAs, SNFs, IRFs, and LTCHs) to
submit standardized patient assessment
data in accordance with section
1899B(b) of the Act, data on quality
measures required under section
1899B(c)(1) of the Act, and data on
resource use and other measures
required under section 1899B(d)(1) of
the Act. The Act also sets out specified
application dates for each of the
measures. The Secretary must specify
the quality, resource use, and other
measures not later than the applicable
specified application date defined in
section 1899B(a)(2)(E) of the Act.
In this proposed rule, we are
proposing three previously finalized
quality measures: One measure proposal
establishes the newly NQF-endorsed
status of that quality measure; two other
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measure proposals are for the purpose of
establishing the cross-setting use of the
previously finalized quality measures,
in order to satisfy the IMPACT Act of
2014 requirement of adopting quality
measures under the domains of skin
integrity and falls with major injury. We
are proposing to adopt an ‘‘application
of’’ a fourth previously finalized LTCH
functional status measure in order to
meet the requirement of the IMPACT
Act of 2014 to adopt a cross-setting
measure under the domain of functional
status, such as self-care or mobility. All
four measure proposals effect the FY
2018 annual payment update
determination and beyond.
In addition, we are proposing to
publicly report LTCH quality data
beginning in fall 2016, on a CMS Web
site, such as Hospital Compare. We are
proposing to initially publicly report
quality data on four quality measures.
Finally, we are proposing to lengthen
our quarterly data submission deadlines
from 45 days to 135 days beyond the
end of each calendar year quarter
beginning with quarter four (4) 2015
quality data. We are proposing this
change in order to align with other
quality reporting programs, and to allow
an appropriate amount of time for
LTCHs to review and correct quality
data prior to the public posting of that
data.
3. Summary of Costs and Benefits
• Adjustment for MS–DRG
Documentation and Coding Changes.
We are proposing to make a ¥0.8
percent recoupment adjustment to the
standardized amount for FY 2016 to
implement, in part, the requirement of
section 631 of the ATRA that the
Secretary make an adjustment totaling
$11 billion over a 4-year period of FYs
2014, 2015, 2016, and 2017. This
proposed recoupment adjustment
represents the amount of the increase in
aggregate payments as a result of not
completing the prospective adjustment
authorized under section 7(b)(1)(A) of
Public Law 110–90 until FY 2013. Prior
to the ATRA, this amount could not
have been recovered under Public Law
110–90.
While our actuaries estimated that a
¥9.3 percent recoupment adjustment to
the standardized amount would be
necessary if CMS were to fully recover
the $11 billion recoupment required by
section 631 of the ATRA in FY 2014, it
is often our practice to delay or phase
in rate adjustments over more than one
year, in order to moderate the effects on
rates in any one year. Therefore,
consistent with the policies that we
have adopted in many similar cases and
the adjustment we made for FY 2014,
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we are proposing to make a ¥0.8
percent recoupment adjustment to the
standardized amount in FY 2016.
Considering the ¥0.8 percent
adjustments made in FY 2014 and FY
2015, we estimate that the combined
impact of the proposed adjustment for
FY 2016 and leaving the FY 2014 and
FY 2015 adjustments in place would be
to recover up to $3 billion in FY 2016.
Combined with the effects of the ¥0.8
percent adjustments implemented in FY
2014 and FY 2015, we estimate that the
proposed FY 2016 ¥0.8 percent
adjustment would result in the recovery
of a total of approximately $6 billion of
the $11 billion in overpayments
required to be recovered by section 631
of the ATRA.
• Proposed Changes to the Hospital
Readmissions Reduction Program. We
are proposing a refinement to the
pneumonia readmissions measure,
which would expand the measure
cohort for the FY 2017 payment
determination and subsequent years. In
addition, we are proposing to adopt an
extraordinary circumstance exception
policy that would align with existing
extraordinary circumstance exception
policies for other IPPS quality reporting
and payment programs and would allow
hospitals that experience an
extraordinary circumstance (such as a
hurricane or flood) to request a waiver
for use of data from the affected time
period. These proposed changes would
not significantly impact the program in
FY 2016, but could impact future years,
depending on actual experience.
• Value-Based Incentive Payments
under the Hospital VBP Program. We
estimate that there would be no net
financial impact to the Hospital VBP
Program for the FY 2016 program year
in the aggregate because, by law, the
amount available for value-based
incentive payments under the program
in a given year must be equal to the total
amount of base operating MS–DRG
payment amount reductions for that
year, as estimated by the Secretary. The
estimated amount of base operating MS–
DRG payment amount reductions for the
FY 2016 program year and, therefore,
the estimated amount available for
value-based incentive payments for FY
2016 discharges is approximately $1.5
billion. We believe that the program
benefits will be seen in improved
patient outcomes, safety, and in the
patient’s experience of care. However,
we cannot estimate these benefits in
actual dollar and patient terms.
• Proposed Changes to the HAC
Reduction Program for FY 2016. We are
proposing three changes to existing
HAC Reduction Program policies: (1) An
expansion to the population covered by
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the central line-associated bloodstream
infection (CLABSI) and catheterassociated urinary tract infection
(CAUTI) measures to include patients in
select nonintensive care unit sites
within a hospital; (2) an adjustment to
the relative contribution of each domain
to the Total HAC Score that is used to
determine if a hospital will receive the
payment adjustment; and (3) a policy
that would align with existing
extraordinary circumstance exception
policies for other IPPS quality reporting
and payment programs and would allow
hospitals to request a waiver for use of
data from the affected period. While
hospitals in the top quartile of HAC
scores will continue to have their HAC
Reduction Program payment adjustment
applied, as required by law, because a
hospital’s Total HAC score and its
ranking in comparison to other hospitals
in any given year depend on several
different factors, any significant impact
due to the proposed changes, including
which hospitals receive the adjustment,
would depend on actual experience.
• Medicare DSH Payment Adjustment
and Additional Payment for
Uncompensated Care. Under section
1886(r) of the Act (as added by section
3313 of the Affordable Care Act),
disproportionate share hospital
payments to hospitals under section
1886(d)(5)(F) of the Act are reduced and
an additional payment for
uncompensated care is made to eligible
hospitals beginning in FY 2014.
Hospitals that receive Medicare DSH
payments will receive 25 percent of the
amount they previously would have
received under the current statutory
formula for Medicare DSH payments in
section 1886(d)(5)(F) of the Act. The
remainder, equal to an estimate of 75
percent of what otherwise would have
been paid as Medicare DSH payments,
will be the basis for determining the
additional payments for uncompensated
care after the amount is reduced for
changes in the percentage of individuals
that are uninsured and additional
statutory adjustments. Each hospital
that receives Medicare DSH payments
will receive an additional payment for
uncompensated care based on its share
of the total uncompensated care amount
reported by Medicare DSHs. The
reduction to Medicare DSH payments is
not budget neutral.
For FY 2016, we are proposing to
provide that the 75 percent of what
otherwise would have been paid for
Medicare DSH is adjusted to
approximately 63.69 percent of the
amount to reflect changes in the
percentage of individuals that are
uninsured and additional statutory
adjustments. In other words,
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approximately 47.76 percent (the
product of 75 percent and 63.69
percent) of our estimate of Medicare
DSH payments prior to the application
of section 3133 of the Affordable Care
Act is available to make additional
payment to hospitals for their relative
share of the total amount of
uncompensated care. We project that
Medicare DSH payments and additional
payments for uncompensated care made
for FY 2016 would reduce payments
overall by approximately 1 percent as
compared to the Medicare DSH
payments and uncompensated care
payments distributed in FY 2015. The
additional payments have redistributive
effects based on a hospital’s
uncompensated care amount relative to
the uncompensated care amount for all
hospitals that are estimated to receive
Medicare DSH payments, and the
proposed payment amount is not
directly tied to a hospital’s number of
discharges.
• Proposed Update to the LTCH PPS
Payment Rates and Other Payment
Factors. Based on the best available data
for the 418 LTCHs in our data base, we
estimate that the proposed changes to
the payment rates and factors that we
are presenting in the preamble and
Addendum of this proposed rule,
including the proposed application of
the new site neutral payment rate
required by section 1886(m)(6)(A) of the
Act, the proposed update to the LTCH
PPS standard Federal rate for FY 2016,
and the proposed changes to short-stay
outlier and high-cost outlier payments
would result in an estimated decrease in
payments from FY 2015 of
approximately $251 million (or 4.6
percent).
• Hospital Inpatient Quality
Reporting (IQR) Program. In this
proposed rule, we are proposing to
remove nine measures for the FY 2018
payment determination and subsequent
years. We are proposing to add eight
measures to the hospital IQR Program
for the FY 2018 payment determination
and subsequent years. We also are
proposing to require hospitals to report
16 of the 28 Hospital IQR Program
electronic clinical quality measures that
align with the Medicare EHR Incentive
Program and span three different NQS
domains. We estimate that our
proposals for the adoption and removal
of measures will result in total hospital
costs of $169 million across 3,300 IPPS
hospitals.
• Changes in LTCH Payments Related
to the LTCH QRP Proposals. We believe
that the increase in costs to LTCHs
related to our LTCH QRP proposals in
this proposed rule is zero. We refer
readers to sections VIII.C. of the
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preamble of this proposed rule for
detailed discussion of the proposals.
B. Summary
1. Acute Care Hospital Inpatient
Prospective Payment System (IPPS)
Section 1886(d) of the Social Security
Act (the Act) sets forth a system of
payment for the operating costs of acute
care hospital inpatient stays under
Medicare Part A (Hospital Insurance)
based on prospectively set rates. Section
1886(g) of the Act requires the Secretary
to use a prospective payment system
(PPS) to pay for the capital-related costs
of inpatient hospital services for these
‘‘subsection (d) hospitals.’’ Under these
PPSs, Medicare payment for hospital
inpatient operating and capital-related
costs is made at predetermined, specific
rates for each hospital discharge.
Discharges are classified according to a
list of diagnosis-related groups (DRGs).
The base payment rate is comprised of
a standardized amount that is divided
into a labor-related share and a
nonlabor-related share. The laborrelated share is adjusted by the wage
index applicable to the area where the
hospital is located. If the hospital is
located in Alaska or Hawaii, the
nonlabor-related share is adjusted by a
cost-of-living adjustment factor. This
base payment rate is multiplied by the
DRG relative weight.
If the hospital treats a high percentage
of certain low-income patients, it
receives a percentage add-on payment
applied to the DRG-adjusted base
payment rate. This add-on payment,
known as the disproportionate share
hospital (DSH) adjustment, provides for
a percentage increase in Medicare
payments to hospitals that qualify under
either of two statutory formulas
designed to identify hospitals that serve
a disproportionate share of low-income
patients. For qualifying hospitals, the
amount of this adjustment varies based
on the outcome of the statutory
calculations. The Affordable Care Act
revised the Medicare DSH payment
methodology and provides for a new
additional Medicare payment that
considers the amount of uncompensated
care beginning on October 1, 2013.
If the hospital is an approved teaching
hospital, it receives a percentage add-on
payment for each case paid under the
IPPS, known as the indirect medical
education (IME) adjustment. This
percentage varies, depending on the
ratio of residents to beds.
Additional payments may be made for
cases that involve new technologies or
medical services that have been
approved for special add-on payments.
To qualify, a new technology or medical
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service must demonstrate that it is a
substantial clinical improvement over
technologies or services otherwise
available, and that, absent an add-on
payment, it would be inadequately paid
under the regular DRG payment.
The costs incurred by the hospital for
a case are evaluated to determine
whether the hospital is eligible for an
additional payment as an outlier case.
This additional payment is designed to
protect the hospital from large financial
losses due to unusually expensive cases.
Any eligible outlier payment is added to
the DRG-adjusted base payment rate,
plus any DSH, IME, and new technology
or medical service add-on adjustments.
Although payments to most hospitals
under the IPPS are made on the basis of
the standardized amounts, some
categories of hospitals are paid in whole
or in part based on their hospitalspecific rate, which is determined from
their costs in a base year. For example,
sole community hospitals (SCHs)
receive the higher of a hospital-specific
rate based on their costs in a base year
(the highest of FY 1982, FY 1987, FY
1996, or FY 2006) or the IPPS Federal
rate based on the standardized amount.
(We note that the statutory provision for
Medicare payments to MDHs expired on
March 31, 2015, under current law.)
SCHs are the sole source of care in their
areas. Specifically, section
1886(d)(5)(D)(iii) of the Act defines an
SCH as a hospital that is located more
than 35 road miles from another
hospital or that, by reason of factors
such as isolated location, weather
conditions, travel conditions, or absence
of other like hospitals (as determined by
the Secretary), is the sole source of
hospital inpatient services reasonably
available to Medicare beneficiaries. In
addition, certain rural hospitals
previously designated by the Secretary
as essential access community hospitals
are considered SCHs.
Section 1886(g) of the Act requires the
Secretary to pay for the capital-related
costs of inpatient hospital services ‘‘in
accordance with a prospective payment
system established by the Secretary.’’
The basic methodology for determining
capital prospective payments is set forth
in our regulations at 42 CFR 412.308
and 412.312. Under the capital IPPS,
payments are adjusted by the same DRG
for the case as they are under the
operating IPPS. Capital IPPS payments
are also adjusted for IME and DSH,
similar to the adjustments made under
the operating IPPS. In addition,
hospitals may receive outlier payments
for those cases that have unusually high
costs.
The existing regulations governing
payments to hospitals under the IPPS
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are located in 42 CFR part 412, subparts
A through M.
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2. Hospitals and Hospital Units
Excluded From the IPPS
Under section 1886(d)(1)(B) of the
Act, as amended, certain hospitals and
hospital units are excluded from the
IPPS. These hospitals and units are:
Rehabilitation hospitals and units; longterm care hospitals (LTCHs); psychiatric
hospitals and units; children’s hospitals;
certain cancer hospitals; and short-term
acute care hospitals located in Guam,
the U.S. Virgin Islands, the Northern
Mariana Islands, and American Samoa.
Religious nonmedical health care
institutions (RNHCIs) are also excluded
from the IPPS. Various sections of the
Balanced Budget Act of 1997 (BBA, Pub.
L. 105–33), the Medicare, Medicaid and
SCHIP [State Children’s Health
Insurance Program] Balanced Budget
Refinement Act of 1999 (BBRA, Pub. L.
106–113), and the Medicare, Medicaid,
and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA, Pub. L.
106–554) provide for the
implementation of PPSs for
rehabilitation hospitals and units
(referred to as inpatient rehabilitation
facilities (IRFs)), LTCHs, and psychiatric
hospitals and units (referred to as
inpatient psychiatric facilities (IPFs)).
(We note that the annual updates to the
LTCH PPS are now included as part of
the IPPS annual update document.
Updates to the IRF PPS and IPF PPS are
issued as separate documents.)
Children’s hospitals, certain cancer
hospitals, short-term acute care
hospitals located in Guam, the U.S.
Virgin Islands, the Northern Mariana
Islands, and American Samoa, and
RNHCIs continue to be paid solely
under a reasonable cost-based system
subject to a rate-of-increase ceiling on
inpatient operating costs, as updated
annually by the percentage increase in
the IPPS operating market basket.
The existing regulations governing
payments to excluded hospitals and
hospital units are located in 42 CFR
parts 412 and 413.
3. Long-Term Care Hospital Prospective
Payment System (LTCH PPS)
The Medicare prospective payment
system (PPS) for LTCHs applies to
hospitals described in section
1886(d)(1)(B)(iv) of the Act effective for
cost reporting periods beginning on or
after October 1, 2002. The LTCH PPS
was established under the authority of
section 123 of the BBRA and section
307(b) of the BIPA (as codified under
section 1886(m)(1) of the Act). During
the 5-year (optional) transition period, a
LTCH’s payment under the PPS was
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based on an increasing proportion of the
LTCH Federal rate with a corresponding
decreasing proportion based on
reasonable cost principles. Effective for
cost reporting periods beginning on or
after October 1, 2006, all LTCHs are
paid 100 percent of the Federal rate.
Section 1206(a) of Public Law 113–67
established the site neutral payment rate
under the LTCH PPS. Under this statute,
based on a rolling effective date that is
linked to the date on which a given
LTCH’s Federal FY 2016 cost reporting
period begins, LTCHs will be paid for
LTCH discharges at the new site neutral
payment rate unless the discharge meets
the patient criteria for payment at the
LTCH PPS standard Federal rate. The
existing regulations governing payment
under the LTCH PPS are located in 42
CFR part 412, subpart O. Beginning with
FY 2009, annual updates to the LTCH
PPS are published in the same
documents that update the IPPS (73 FR
26797 through 26798).
4. Critical Access Hospitals (CAHs)
Under sections 1814(l), 1820, and
1834(g) of the Act, payments made to
critical access hospitals (CAHs) (that is,
rural hospitals or facilities that meet
certain statutory requirements) for
inpatient and outpatient services are
generally based on 101 percent of
reasonable cost. Reasonable cost is
determined under the provisions of
section 1861(v)(1)(A) of the Act and
existing regulations under 42 CFR part
413.
5. Payments for Graduate Medical
Education (GME)
Under section 1886(a)(4) of the Act,
costs of approved educational activities
are excluded from the operating costs of
inpatient hospital services. Hospitals
with approved graduate medical
education (GME) programs are paid for
the direct costs of GME in accordance
with section 1886(h) of the Act. The
amount of payment for direct GME costs
for a cost reporting period is based on
the hospital’s number of residents in
that period and the hospital’s costs per
resident in a base year. The existing
regulations governing payments to the
various types of hospitals are located in
42 CFR part 413.
C. Summary of Provisions of Recent
Legislation Discussed in This Proposed
Rule
The American Taxpayer Relief Act of
2012 (ATRA) (Pub. L. 112–240), enacted
on January 2, 2013, made a number of
changes that affect the IPPS. We
announced changes related to certain
IPPS provisions for FY 2013 in
accordance with sections 605 and 606 of
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Public Law 112–240 in a notice that
appeared in the Federal Register on
March 7, 2013 (78 FR 14689).
The Pathway for Sustainable Growth
Rate (SGR) Reform Act of 2013 (Pub. L.
113–67), enacted on December 26, 2013,
also made a number of changes that
affect the IPPS and the LTCH PPS. We
implemented changes related to the
low-volume hospital payment
adjustment and MDH provisions for FY
2014 in accordance with sections 1105
and 1106 of Public Law 113–67 in an
interim final rule with comment period
that appeared in the Federal Register on
March 18, 2014 (79 FR 15022).
The Protecting Access to Medicare
Act of 2014 (Pub. L. 113–93), enacted on
April 1, 2014, also made a number of
changes that affect the IPPS and LTCH
PPS.
The Improving Medicare Post-Acute
Care Transformation Act of 2014
(IMPACT Act of 2014) (Pub. L. 113–
185), enacted on October 6, 2014, made
a number of changes that affect the
Long-Term Care Quality Reporting
Program (LTCH QRP).
1. American Taxpayer Relief Act of 2012
(ATRA) (Pub. L. 112–240)
In this proposed rule, we are
proposing to make policy changes to
implement section 631 of the American
Taxpayer Relief Act of 2012, which
amended section 7(b)(1)(B) of Public
Law 110–90 and requires a recoupment
adjustment to the standardized amounts
under section 1886(d) of the Act based
upon the Secretary’s estimates for
discharges occurring in FY 2014
through FY 2017 to fully offset $11
billion (which represents the amount of
the increase in aggregate payments from
FYs 2008 through 2013 for which an
adjustment was not previously applied).
2. Pathway for Sustainable Growth Rate
(SGR) Reform Act of 2013 (Pub. L. 113–
67)
In this proposed rule, we are
proposing to make policy changes to
implement and discuss the need for
future policy changes to carry out
provisions under section 1206 of the
Pathway for SGR Reform Act of 2013.
These include:
• Section 1206(a), which provides for
the establishment of patient criteria for
exclusion from the new ‘‘site neutral’’
payment rate under the LTCH PPS,
beginning in FY 2016.
• Section 1206(a)(3), which requires
changes to the LTCH average length of
stay criterion.
• Section 1206(b)(1), which further
amended section 114(c) of the MMSEA,
as amended by section 4302(a) of the
ARRA and sections 3106(c) and
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10312(a) of the Affordable Care Act by
retroactively reestablishing, and
extending, the statutory moratorium on
the full implementation of the 25percent threshold payment adjustment
policy under the LTCH PPS so that the
policy will be in effect for 9 years
(except for grandfathered hospitalswithin-hospitals (HwHs), which it
permanently exempted from this
policy).
• Section 1206(b)(2), which amended
section 114(d) of the MMSEA, as
amended by section 4302(a) of the
ARRA and sections 3106(c) and
10312(a) of the Affordable Care Act to
establish new moratoria (subject to
certain defined exceptions) on the
development of new LTCHs and LTCH
satellite facilities and a new moratorium
on increases in the number of beds in
existing LTCHs and LTCH satellite
facilities.
3. Protecting Access to Medicare Act of
2014 (Pub. L. 113–93)
In this proposed rule, we are
proposing to make policy changes to
implement, or making conforming
changes to regulations in accordance
with, the following provisions (or
portions of the following provisions) of
the Protecting Access to Medicare Act of
2014 that are applicable to the IPPS and
the LTCH PPS for FY 2016:
• Section 112, which makes certain
changes to Medicare LTCH provisions,
including modifications to the statutory
moratoria on the establishment of new
LTCHs and LTCH satellite facilities.
• Section 212, which prohibits the
Secretary from requiring
implementation of ICD–10 code sets
before October 1, 2015.
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4. Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT
Act of 2014) (Pub. L. 113–185)
In this proposed rule, we are
proposing to implement portions of
section 2 of the IMPACT Act of 2014,
which, in part, requires LTCHs, among
other postacute care providers, to report
standardized patient assessment data,
data on quality measures, and data on
resource use and other measures.
D. Summary of the Major Provisions of
This Proposed Rule
In this proposed rule, we set forth
proposed changes to the Medicare IPPS
for operating costs and for capitalrelated costs of acute care hospitals for
FY 2016. We also set forth proposed
changes relating to payments to certain
hospitals that continue to be excluded
from the IPPS and paid on a reasonable
cost basis. In addition, in this proposed
rule, we set forth proposed changes to
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the payment rates, factors, and other
payment rate policies under the LTCH
PPS for FY 2016.
Below is a summary of the major
changes that we are proposing to make:
1. Proposed Changes to MS–DRG
Classifications and Recalibrations of
Relative Weights
In section II. of the preamble of this
proposed rule, we include—
• Proposed changes to MS–DRG
classifications based on our yearly
review, including a discussion of the
conversion of MS–DRGs to ICD–10 and
the implementation of the ICD–10–CM
and ICD–10–PCS systems.
• Proposed application of the
documentation and coding adjustment
for FY 2016 resulting from
implementation of the MS–DRG system.
• Proposed recalibrations of the MS–
DRG relative weights.
• Proposed changes to hospitalacquired conditions (HACs) and a
discussion of HACs, including
infections, that would be subject to the
statutorily required adjustment in MS–
DRG payments for FY 2016.
• A discussion of the FY 2016 status
of new technologies approved for addon payments for FY 2015 and a
presentation of our evaluation and
analysis of the FY 2016 applicants for
add-on payments for high-cost new
medical services and technologies
(including public input, as directed by
Pub. L. 108–173, obtained in a town hall
meeting).
2. Proposed Changes to the Hospital
Wage Index for Acute Care Hospitals
In section III. of the preamble to this
proposed rule, we are proposing
revisions to the wage index for acute
care hospitals and the annual update of
the wage data. Specific issues addressed
included the following:
• The proposed FY 2016 wage index
update using wage data from cost
reporting periods beginning in FY 2012.
• Calculation of the proposed
occupational mix adjustment for FY
2016 based on the 2013 Occupational
Mix Survey.
• Analysis and implementation of the
proposed FY 2016 occupational mix
adjustment to the wage index for acute
care hospitals.
• Proposed application of the rural
floor, the proposed imputed rural floor,
and the proposed frontier State floor.
• Transitional wage indexes relating
to the continued use of the revised OMB
labor market area delineations based on
2010 Decennial Census data.
• Proposed revisions to the wage
index for acute care hospitals based on
hospital redesignations and
reclassifications.
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• The proposed out-migration
adjustment to the wage index for acute
care hospitals for FY 2016 based on
commuting patterns of hospital
employees who reside in a county and
work in a different area with a higher
wage index. Beginning in FY 2016, we
are proposing new out-migration
adjustments based on commuting
patterns obtained from 2010 Decennial
Census data.
• The timetable for reviewing and
verifying the wage data used to compute
the proposed FY 2016 hospital wage
index.
• Determination of the labor-related
share for the proposed FY 2016 wage
index.
• Proposed changes to the 3-year
average pension policy and proposed
changes to the wage index timetable
regarding pension cost for FY 2017 and
subsequent years.
• Clarification of the allocation of
pension costs for the wage index.
3. Other Decisions and Proposed
Changes to the IPPS for Operating Costs
and Indirect Medical Education (IME)
Costs
In section IV. of the preamble of this
proposed rule, we discuss proposed
changes or clarifications of a number of
the provisions of the regulations in 42
CFR parts 412 and 413, including the
following:
• Proposed changes to the inpatient
hospital updates for FY 2016, including
the adjustment for hospitals that are not
meaningful EHR users under section
1886(b)(3)(B)(ix) of the Act.
• The proposed updated national and
regional case-mix values and discharges
for purposes of determining RRC status.
• The statutorily required IME
adjustment factor for FY 2016.
• Proposal for determining Medicare
DSH payments and the additional
payments for uncompensated care for
FY 2016.
• Proposed changes to the measures
and payment adjustments under the
Hospital Readmissions Reduction
Program.
• Proposed changes to the
requirements and provision of valuebased incentive payments under the
Hospital Value-Based Purchasing
Program.
• Proposed requirements for payment
adjustments to hospitals under the HAC
Reduction Program for FY 2016.
• Proposed elimination of the
election by hospitals to use the
simplified cost allocation methodology
for Medicare cost reports.
• Discussion of the Rural Community
Hospital Demonstration Program and a
proposal for making a budget neutrality
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adjustment for the demonstration
program.
• Proposed changes in postacute care
transfer policies as a result of proposed
new MS–DRGs.
• A statement of our intent to discuss
issues related to short inpatient hospital
stays, long outpatient stays with
observation services, and the related
¥0.2 percent IPPS payment adjustment
in the CY 2016 hospital outpatient
prospective payment system proposed
rule that will be published this summer.
4. Proposed FY 2016 Policy Governing
the IPPS for Capital-Related Costs
In section V. of the preamble to this
proposed rule, we discuss the proposed
payment policy requirements for
capital-related costs and capital
payments to hospitals for FY 2016.
5. Proposed Changes to the Payment
Rates for Certain Excluded Hospitals:
Rate-of-Increase Percentages
In section VI. of the preamble of this
proposed rule, we discuss proposed
changes to payments to certain excluded
hospitals for FY 2016.
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6. Proposed Changes to the LTCH PPS
In section VII. of the preamble of this
proposed rule, we set forth—
• Proposed changes to the LTCH PPS
Federal payment rates, factors, and
other payment rate policies under the
LTCH PPS for FY 2016.
• Proposals to implement section
1206(a)(1) of the Pathway for SGR
Reform Act, which established the site
neutral payment rate as the default
means of paying for discharges in LTCH
cost reporting periods beginning on or
after October 1, 2015.
• Provisions to make technical
clarifications regarding the moratoria on
the establishment of new LTCHs and
LTCH satellite facilities and on bed
increases in existing LTCHs and LTCH
satellite facilities that were established
by section 1206(b)(2) of the Pathway for
SGR Reform, as amended, as well as a
proposal to make a technical revision to
the regulations to more clearly reflect
our established policies.
• Proposal to revise the average
length of stay criterion for LTCHs to
implement section 1206(a)(3) of the
Pathway for SGR Reform Act.
7. Proposed Changes Relating to Quality
Data Reporting for Specific Providers
and Suppliers
In section VIII. of the preamble of this
proposed rule, we address—
• Proposed requirements for the
Hospital Inpatient Quality Reporting
(IQR) Program as a condition for
receiving the full applicable percentage
increase.
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• Proposed changes to the
requirements for the quality reporting
program for PPS-exempt cancer
hospitals (PCHQR Program).
• Proposed changes to the
requirements under the LTCH Quality
Reporting Program (LTCH QRP).
• Proposed changes to align the
reporting and submission timelines for
the electronic submission of clinical
quality measures for the Medicare
Electronic Health Record (EHR)
Incentive Program for eligible hospitals
and CAHs with the reporting and
submission of timelines for the Hospital
IQR Program, including a proposal to
establish in regulations an EHR
technology certification criterion for
reporting clinical quality measures.
8. Determining Prospective Payment
Operating and Capital Rates and Rate-ofIncrease Limits for Acute Care Hospitals
In the Addendum to this proposed
rule, we set forth proposed changes to
the amounts and factors for determining
the proposed FY 2016 prospective
payment rates for operating costs and
capital-related costs for acute care
hospitals. We also are proposing to
establish the threshold amounts for
outlier cases. In addition, we address
the update factors for determining the
rate-of-increase limits for cost reporting
periods beginning in FY 2016 for certain
hospitals excluded from the IPPS.
9. Determining Standard Federal
Payment Rates for LTCHs
In the Addendum to this proposed
rule, we set forth proposed changes to
the amounts and factors for determining
the proposed FY 2016 LTCH PPS
standard Federal payment rate. We are
proposing to establish the adjustments
for wage levels, the labor-related share,
the cost-of-living adjustment, and highcost outliers, including the fixed-loss
amount, and the LTCH cost-to-charge
ratios (CCRs) under the LTCH PPS.
10. Impact Analysis
In Appendix A of this proposed rule,
we set forth an analysis of the impact
that the proposed changes would have
on affected acute care hospitals, LTCHs,
and PCHs.
11. Recommendation of Update Factors
for Operating Cost Rates of Payment for
Hospital Inpatient Services
In Appendix B of this proposed rule,
as required by sections 1886(e)(4) and
(e)(5) of the Act, we provide our
recommendations of the appropriate
percentage changes for FY 2016 for the
following:
• A single average standardized
amount for all areas for hospital
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inpatient services paid under the IPPS
for operating costs of acute care
hospitals (and hospital-specific rates
applicable to SCHs).
• Target rate-of-increase limits to the
allowable operating costs of hospital
inpatient services furnished by certain
hospitals excluded from the IPPS.
• The standard Federal payment rate
for hospital inpatient services furnished
by LTCHs.
12. Discussion of Medicare Payment
Advisory Commission
Recommendations
Under section 1805(b) of the Act,
MedPAC is required to submit a report
to Congress, no later than March 15 of
each year, in which MedPAC reviews
and makes recommendations on
Medicare payment policies. MedPAC’s
March 2015 recommendations
concerning hospital inpatient payment
policies address the update factor for
hospital inpatient operating costs and
capital-related costs for hospitals under
the IPPS. We address these
recommendations in Appendix B of the
proposed rule. For further information
relating specifically to the MedPAC
March 2015 report or to obtain a copy
of the report, contact MedPAC at (202)
220–3700 or visit MedPAC’s Web site at:
https://www.medpac.gov.
II. Proposed Changes to Medicare
Severity Diagnosis-Related Group (MS–
DRG) Classifications and Relative
Weights
A. Background
Section 1886(d) of the Act specifies
that the Secretary shall establish a
classification system (referred to as
diagnosis-related groups (DRGs)) for
inpatient discharges and adjust
payments under the IPPS based on
appropriate weighting factors assigned
to each DRG. Therefore, under the IPPS,
Medicare pays for inpatient hospital
services on a rate per discharge basis
that varies according to the DRG to
which a beneficiary’s stay is assigned.
The formula used to calculate payment
for a specific case multiplies an
individual hospital’s payment rate per
case by the weight of the DRG to which
the case is assigned. Each DRG weight
represents the average resources
required to care for cases in that
particular DRG, relative to the average
resources used to treat cases in all
DRGs.
Congress recognized that it would be
necessary to recalculate the DRG
relative weights periodically to account
for changes in resource consumption.
Accordingly, section 1886(d)(4)(C) of
the Act requires that the Secretary
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adjust the DRG classifications and
relative weights at least annually. These
adjustments are made to reflect changes
in treatment patterns, technology, and
any other factors that may change the
relative use of hospital resources.
B. MS–DRG Reclassifications
For general information about the
MS–DRG system, including yearly
reviews and changes to the MS–DRGs,
we refer readers to the previous
discussions in the FY 2010 IPPS/RY
2010 LTCH PPS final rule (74 FR 43764
through 43766), the FY 2011 IPPS/LTCH
PPS final rule (75 FR 50053 through
50055), the FY 2012 IPPS/LTCH PPS
final rule (76 FR 51485 through 51487),
the FY 2013 IPPS/LTCH PPS final rule
(77 FR 53273), the FY 2014 IPPS/LTCH
PPS final rule (78 FR 50512), and the FY
2015 IPPS/LTCH PPS final rule (79 FR
49871).
C. Adoption of the MS–DRGs in FY 2008
For information on the adoption of
the MS–DRGs in FY 2008, we refer
readers to the FY 2008 IPPS final rule
with comment period (72 FR 47140
through 47189).
D. Proposed FY 2016 MS–DRG
Documentation and Coding Adjustment
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1. Background on the Prospective MS–
DRG Documentation and Coding
Adjustments for FY 2008 and FY 2009
Authorized by Public Law 110–90
In the FY 2008 IPPS final rule with
comment period (72 FR 47140 through
47189), we adopted the MS–DRG
patient classification system for the
IPPS, effective October 1, 2007, to better
recognize severity of illness in Medicare
payment rates for acute care hospitals.
The adoption of the MS–DRG system
resulted in the expansion of the number
of DRGs from 538 in FY 2007 to 745 in
FY 2008. (Currently, for FY 2015, there
are 775 MS–DRGs.) By increasing the
number of MS–DRGs and more fully
taking into account patient severity of
illness in Medicare payment rates for
acute care hospitals, MS–DRGs
encourage hospitals to improve their
documentation and coding of patient
diagnoses.
In the FY 2008 IPPS final rule with
comment period (72 FR 47175 through
47186), we indicated that the adoption
of the MS–DRGs had the potential to
lead to increases in aggregate payments
without a corresponding increase in
actual patient severity of illness due to
the incentives for additional
documentation and coding. In that final
rule with comment period, we exercised
our authority under section
1886(d)(3)(A)(vi) of the Act, which
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authorizes us to maintain budget
neutrality by adjusting the national
standardized amount, to eliminate the
estimated effect of changes in coding or
classification that do not reflect real
changes in case-mix. Our actuaries
estimated that maintaining budget
neutrality required an adjustment of
¥4.8 percent to the national
standardized amount. We provided for
phasing in this ¥4.8 percent adjustment
over 3 years. Specifically, we
established prospective documentation
and coding adjustments of ¥1.2 percent
for FY 2008, ¥1.8 percent for FY 2009,
and ¥1.8 percent for FY 2010.
On September 29, 2007, Congress
enacted the TMA [Transitional Medical
Assistance], Abstinence Education, and
QI [Qualifying Individuals] Programs
Extension Act of 2007 (Pub. L. 110–90).
Section 7(a) of Public Law 110–90
reduced the documentation and coding
adjustment made as a result of the MS–
DRG system that we adopted in the FY
2008 IPPS final rule with comment
period to ¥0.6 percent for FY 2008 and
¥0.9 percent for FY 2009, and we
finalized the FY 2008 adjustment
through rulemaking, effective October 1,
2007 (72 FR 66886).
For FY 2009, section 7(a) of Public
Law 110–90 required a documentation
and coding adjustment of ¥0.9 percent,
and we finalized that adjustment
through rulemaking effective October 1,
2008 (73 FR 48447). The documentation
and coding adjustments established in
the FY 2008 IPPS final rule with
comment period, which reflected the
amendments made by section 7(a) of
Public Law 110–90, are cumulative. As
a result, the ¥0.9 percent
documentation and coding adjustment
for FY 2009 was in addition to the ¥0.6
percent adjustment for FY 2008,
yielding a combined effect of ¥1.5
percent.
2. Adjustment to the Average
Standardized Amounts Required by
Public Law 110–90
a. Prospective Adjustment Required by
Section 7(b)(1)(A) of Public Law 110–90
Section 7(b)(1)(A) of Public Law 110–
90 requires that, if the Secretary
determines that implementation of the
MS–DRG system resulted in changes in
documentation and coding that did not
reflect real changes in case-mix for
discharges occurring during FY 2008 or
FY 2009 that are different than the
prospective documentation and coding
adjustments applied under section 7(a)
of Public Law 110–90, the Secretary
shall make an appropriate adjustment
under section 1886(d)(3)(A)(vi) of the
Act. Section 1886(d)(3)(A)(vi) of the Act
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authorizes adjustments to the average
standardized amounts for subsequent
fiscal years in order to eliminate the
effect of such coding or classification
changes. These adjustments are
intended to ensure that future annual
aggregate IPPS payments are the same as
the payments that otherwise would have
been made had the prospective
adjustments for documentation and
coding applied in FY 2008 and FY 2009
reflected the change that occurred in
those years.
b. Recoupment or Repayment
Adjustments in FYs 2010 Through 2012
Required by Section 7(b)(1)(B) Public
Law 110–90
If, based on a retroactive evaluation of
claims data, the Secretary determines
that implementation of the MS–DRG
system resulted in changes in
documentation and coding that did not
reflect real changes in case-mix for
discharges occurring during FY 2008 or
FY 2009 that are different from the
prospective documentation and coding
adjustments applied under section 7(a)
of Public Law 110–90, section 7(b)(1)(B)
of Public Law 110–90 requires the
Secretary to make an additional
adjustment to the standardized amounts
under section 1886(d) of the Act. This
adjustment must offset the estimated
increase or decrease in aggregate
payments for FYs 2008 and 2009
(including interest) resulting from the
difference between the estimated actual
documentation and coding effect and
the documentation and coding
adjustment applied under section 7(a) of
Public Law 110–90. This adjustment is
in addition to making an appropriate
adjustment to the standardized amounts
under section 1886(d)(3)(A)(vi) of the
Act as required by section 7(b)(1)(A) of
Public Law 110–90. That is, these
adjustments are intended to recoup (or
repay, in the case of underpayments)
spending in excess of (or less than)
spending that would have occurred had
the prospective adjustments for changes
in documentation and coding applied in
FY 2008 and FY 2009 matched the
changes that occurred in those years.
Public Law 110–90 requires that the
Secretary only make these recoupment
or repayment adjustments for discharges
occurring during FYs 2010, 2011, and
2012.
3. Retrospective Evaluation of FY 2008
and FY 2009 Claims Data
In order to implement the
requirements of section 7 of Public Law
110–90, we performed a retrospective
evaluation of the FY 2008 data for
claims paid through December 2008
using the methodology first described in
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the FY 2009 IPPS/LTCH PPS final rule
(73 FR 43768 and 43775) and later
discussed in the FY 2010 IPPS/RY 2010
LTCH PPS final rule (74 FR 43768
through 43772). We performed the same
analysis for FY 2009 claims data using
the same methodology as we did for FY
2008 claims (75 FR 50057 through
50068). The results of the analysis for
the FY 2011 IPPS/LTCH PPS proposed
and final rules, and subsequent
evaluations in FY 2012, supported that
the 5.4 percent estimate accurately
reflected the FY 2009 increases in
documentation and coding under the
MS–DRG system. We were persuaded by
both MedPAC’s analysis (as discussed
in the FY 2011 IPPS/LTCH PPS final
rule (75 FR 50064 through 50065)) and
our own review of the methodologies
recommended by various commenters
that the methodology we employed to
determine the required documentation
and coding adjustments was sound.
As in prior years, the FY 2008, FY
2009, and FY 2010 MedPAR files are
available to the public to allow
independent analysis of the FY 2008
and FY 2009 documentation and coding
effects. Interested individuals may still
order these files through the CMS Web
site at: https://www.cms.gov/ResearchStatistics-Data-and-Systems/Files-forOrder/LimitedDataSets/ by clicking on
MedPAR Limited Data Set (LDS)Hospital (National). This CMS Web page
describes the file and provides
directions and further detailed
instructions for how to order.
Persons placing an order must send
the following: A Letter of Request, the
LDS Data Use Agreement and Research
Protocol (refer to the Web site for further
instructions), the LDS Form, and a
check (refer to the Web site for the
required payment amount) to:
Mailing address if using the U.S.
Postal Service: Centers for Medicare &
Medicaid Services, RDDC Account,
Accounting Division, P.O. Box 7520,
Baltimore, MD 21207–0520.
Mailing address if using express mail:
Centers for Medicare & Medicaid
Services, OFM/Division of Accounting–
RDDC, 7500 Security Boulevard, C3–07–
11, Baltimore, MD 21244–1850.
4. Prospective Adjustments for FY 2008
and FY 2009 Authorized by Section
7(b)(1)(A) of Public Law 110–90
In the FY 2010 IPPS/RY 2010 LTCH
PPS final rule (74 FR 43767 through
43777), we opted to delay the
implementation of any documentation
and coding adjustment until a full
analysis of case-mix changes based on
FY 2009 claims data could be
completed. We refer readers to the FY
2010 IPPS/RY LTCH PPS final rule for
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a detailed description of our proposal,
responses to comments, and finalized
policy. After analysis of the FY 2009
claims data for the FY 2011 IPPS/LTCH
PPS final rule (75 FR 50057 through
50073), we found a total prospective
documentation and coding effect of 5.4
percent. After accounting for the ¥0.6
percent and the ¥0.9 percent
documentation and coding adjustments
in FYs 2008 and 2009, we found a
remaining documentation and coding
effect of 3.9 percent. As we have
discussed, an additional cumulative
adjustment of ¥3.9 percent would be
necessary to meet the requirements of
section 7(b)(1)(A) of Public Law 110–90
to make an adjustment to the average
standardized amounts in order to
eliminate the full effect of the
documentation and coding changes that
do not reflect real changes in case-mix
on future payments. Unlike section
7(b)(1)(B) of Public Law 110–90, section
7(b)(1)(A) does not specify when we
must apply the prospective adjustment,
but merely requires us to make an
‘‘appropriate’’ adjustment. Therefore, as
we stated in the FY 2011 IPPS/LTCH
PPS final rule (75 FR 50061), we
believed the law provided some
discretion as to the manner in which we
applied the prospective adjustment of
¥3.9 percent. As we discussed
extensively in the FY 2011 IPPS/LTCH
PPS final rule, it has been our practice
to moderate payment adjustments when
necessary to mitigate the effects of
significant downward adjustments on
hospitals, to avoid what could be
widespread, disruptive effects of such
adjustments on hospitals. Therefore, we
stated that we believed it was
appropriate to not implement the ¥3.9
percent prospective adjustment in FY
2011 because we finalized a ¥2.9
percent recoupment adjustment for that
fiscal year. Accordingly, we did not
propose a prospective adjustment under
section 7(b)(1)(A) of Public Law 110–90
for FY 2011 (75 FR 23868 through
23870). We noted that, as a result,
payments in FY 2011 (and in each
future fiscal year until we implemented
the requisite adjustment) would be
higher than they would have been if we
had implemented an adjustment under
section 7(b)(1)(A) of Public Law 110–90.
In the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51489 and 51497), we
indicated that, because further delay of
this prospective adjustment would
result in a continued accrual of
unrecoverable overpayments, it was
imperative that we implement a
prospective adjustment for FY 2012,
while recognizing CMS’ continued
desire to mitigate the effects of any
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significant downward adjustments to
hospitals. Therefore, we implemented a
¥2.0 percent prospective adjustment to
the standardized amount instead of the
full ¥3.9 percent.
In the FY 2013 IPPS/LTCH PPS final
rule (77 FR 53274 through 53276), we
completed the prospective portion of
the adjustment required under section
7(b)(1)(A) of Public Law 110–90 by
finalizing a ¥1.9 percent adjustment to
the standardized amount for FY 2013.
We stated that this adjustment would
remove the remaining effect of the
documentation and coding changes that
do not reflect real changes in case-mix
that occurred in FY 2008 and FY 2009.
We believed that it was imperative to
implement the full remaining
adjustment, as any further delay would
result in an overstated standardized
amount in FY 2013 and any future fiscal
years until a full adjustment was made.
We noted again that delaying full
implementation of the prospective
portion of the adjustment required
under section 7(b)(1)(A) of Public Law
110–90 until FY 2013 resulted in
payments in FY 2010 through FY 2012
being overstated. These overpayments
could not be recovered by CMS because
section 7(b)(1)(B) of Public Law 110–90
limited recoupments to overpayments
made in FY 2008 and FY 2009.
5. Recoupment or Repayment
Adjustment Authorized by Section
7(b)(1)(B) of Public Law 110–90
Section 7(b)(1)(B) of Public Law 110–
90 requires the Secretary to make an
adjustment to the standardized amounts
under section 1886(d) of the Act to
offset the estimated increase or decrease
in aggregate payments for FY 2008 and
FY 2009 (including interest) resulting
from the difference between the
estimated actual documentation and
coding effect and the documentation
and coding adjustments applied under
section 7(a) of Public Law 110–90. This
determination must be based on a
retrospective evaluation of claims data.
Our actuaries estimated that there was
a 5.8 percentage point difference
resulting in an increase in aggregate
payments of approximately $6.9 billion.
Therefore, as discussed in the FY 2011
IPPS/LTCH PPS final rule (75 FR 50062
through 50067), we determined that an
aggregate adjustment of ¥5.8 percent in
FYs 2011 and 2012 would be necessary
in order to meet the requirements of
section 7(b)(1)(B) of Public Law 110–90
to adjust the standardized amounts for
discharges occurring in FYs 2010, 2011,
and/or 2012 to offset the estimated
amount of the increase in aggregate
payments (including interest) in FYs
2008 and 2009.
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It is often our practice to phase in
payment rate adjustments over more
than one year in order to moderate the
effect on payment rates in any one year.
Therefore, consistent with the policies
that we have adopted in many similar
cases, in the FY 2011 IPPS/LTCH PPS
final rule, we made an adjustment to the
standardized amount of ¥2.9 percent,
representing approximately one-half of
the aggregate adjustment required under
section 7(b)(1)(B) of Public Law 110–90,
for FY 2011. An adjustment of this
magnitude allowed us to moderate the
effects on hospitals in one year while
simultaneously making it possible to
implement the entire adjustment within
the timeframe required under section
7(b)(1)(B) of Public Law 110–90 (that is,
no later than FY 2012). For FY 2012, in
accordance with the timeframes set
forth by section 7(b)(1)(B) of Public Law
110–90, and consistent with the
discussion in the FY 2011 IPPS/LTCH
PPS final rule, we completed the
recoupment adjustment by
implementing the remaining ¥2.9
percent adjustment, in addition to
removing the effect of the ¥2.9 percent
adjustment to the standardized amount
finalized for FY 2011 (76 FR 51489 and
51498). Because these adjustments, in
effect, balanced out, there was no yearto-year change in the standardized
amount due to this recoupment
adjustment for FY 2012. In the FY 2013
IPPS/LTCH PPS final rule (77 FR
53276), we made a final +2.9 percent
adjustment to the standardized amount,
completing the recoupment portion of
section 7(b)(1)(B) of Public Law 110–90.
We note that with this positive
adjustment, according to our estimates,
all overpayments made in FY 2008 and
FY 2009 have been fully recaptured
with appropriate interest, and the
standardized amount has been returned
to the appropriate baseline.
6. Proposed Recoupment or Repayment
Adjustment Authorized by Section 631
of the American Taxpayer Relief Act of
2012 (ATRA)
Section 631 of the ATRA amended
section 7(b)(1)(B) of Public Law 110–90
to require the Secretary to make a
recoupment adjustment or adjustments
totaling $11 billion by FY 2017. This
adjustment represents the amount of the
increase in aggregate payments as a
result of not completing the prospective
adjustment authorized under section
7(b)(1)(A) of Public Law 110–90 until
FY 2013. As discussed earlier, this delay
in implementation resulted in
overstated payment rates in FYs 2010,
2011, and 2012. The resulting
overpayments could not have been
recovered under Public Law 110–90.
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Similar to the adjustments authorized
under section 7(b)(1)(B) of Public Law
110–90, the adjustment required under
section 631 of the ATRA is a one-time
recoupment of a prior overpayment, not
a permanent reduction to payment rates.
Therefore, any adjustment made to
reduce payment rates in one year would
eventually be offset by a positive
adjustment, once the necessary amount
of overpayment is recovered.
As we stated in the FY 2014 IPPS/
LTCH PPS final rule (78 FR 50515
through 50517), our actuaries estimate
that a ¥9.3 percent adjustment to the
standardized amount would be
necessary if CMS were to fully recover
the $11 billion recoupment required by
section 631 of the ATRA in FY 2014. It
is often our practice to phase in
payment rate adjustments over more
than one year, in order to moderate the
effect on payment rates in any one year.
Therefore, consistent with the policies
that we have adopted in many similar
cases, and after consideration of the
public comments we received, in the FY
2014 IPPS/LTCH PPS final rule (78 FR
50515 through 50517), we implemented
a ¥0.8 percent recoupment adjustment
to the standardized amount in FY 2014.
We stated that if adjustments of
approximately ¥0.8 percent are
implemented in FYs 2014, 2015, 2016,
and 2017, using standard inflation
factors, we estimate that the entire $11
billion will be accounted for by the end
of the statutory 4-year timeline. As
estimates of any future adjustments are
subject to slight variations in total
savings, we did not provide for specific
adjustments for FYs 2015, 2016, or 2017
at that time. We stated that we believed
that this level of adjustment for FY 2014
was a reasonable and fair approach that
satisfies the requirements of the statute
while mitigating extreme annual
fluctuations in payment rates.
Consistent with the approach
discussed in the FY 2014 IPPS/LTCH
PPS final rule for recouping the $11
billion required by section 631 of the
ATRA, in the FY 2015 IPPS/LTCH PPS
final rule (79 FR 49873 through 49874),
we implemented an additional ¥0.8
percent recoupment adjustment to the
standardized amount for FY 2015. We
estimated that this level of adjustment,
combined with leaving the ¥0.8 percent
adjustment made for FY 2014 in place,
will recover up to $2 billion in FY 2015.
When combined with the approximately
$1 billion adjustment made in FY 2014,
we estimated that approximately $8
billion would be left to recover under
section 631 of the ATRA.
Consistent with the approach
discussed in the FY 2014 IPPS/LTCH
PPS final rule for recouping the $11
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billion required by section 631 of the
ATRA, in this FY 2016 IPPS/LTCH PPS
proposed rule, we are proposing to
implement a ¥0.8 percent recoupment
adjustment to the standardized amount
for FY 2016. Considering the ¥0.8
percent adjustments made in FY 2014
and FY 2015, we estimate that the
combined impact of the proposed
adjustment for FY 2016 and leaving the
FY 2014 and FY 2015 adjustments in
place would be to recover up to $3
billion in FY 2016. Combined with the
effects of the ¥0.8 percent adjustments
implemented in FY 2014 and FY 2015,
we estimate that the proposed FY 2016
¥0.8 percent adjustment would result
in the recovery of a total of
approximately $6 billion of the $11
billion in overpayments required to be
recovered by section 631 of the ATRA.
As we explained in the FY 2014 IPPS/
LTCH PPS final rule, estimates of any
future adjustments are subject to slight
variations in total savings. Therefore, we
have not yet addressed the specific
amount of the final adjustment required
under section 631 of the ATRA for FY
2017. We continue to believe that the
proposed ¥0.8 percent adjustment for
FY 2016 is a reasonable and fair
approach that will help satisfy the
requirements of the statute while
mitigating extreme annual fluctuations
in payment rates. In addition, we again
note that this proposed ¥0.8 percent
recoupment adjustment for FY 2016, the
respective ¥0.8 percent adjustments
made in FY 2014 and FY 2015, and any
future adjustment made under this
authority, will be eventually offset by an
equivalent positive adjustment once the
full $11 billion recoupment requirement
has been realized.
E. Refinement of the MS–DRG Relative
Weight Calculation
1. Background
Beginning in FY 2007, we
implemented relative weights for DRGs
based on cost report data instead of
charge information. We refer readers to
the FY 2007 IPPS final rule (71 FR
47882) for a detailed discussion of our
final policy for calculating the costbased DRG relative weights and to the
FY 2008 IPPS final rule with comment
period (72 FR 47199) for information on
how we blended relative weights based
on the CMS DRGs and MS–DRGs.
As we implemented cost-based
relative weights, some public
commenters raised concerns about
potential bias in the weights due to
‘‘charge compression,’’ which is the
practice of applying a higher percentage
charge markup over costs to lower cost
items and services, and a lower
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percentage charge markup over costs to
higher cost items and services. As a
result, the cost-based weights would
undervalue high-cost items and
overvalue low-cost items if a single costto-charge ratio (CCR) is applied to items
of widely varying costs in the same cost
center. To address this concern, in
August 2006, we awarded a contract to
the Research Triangle Institute,
International (RTI) to study the effects of
charge compression in calculating the
relative weights and to consider
methods to reduce the variation in the
CCRs across services within cost
centers. For a detailed summary of RTI’s
findings, recommendations, and public
comments that we received on the
report, we refer readers to the FY 2009
IPPS/LTCH PPS final rule (73 FR 48452
through 48453). In addition, we refer
readers to RTI’s July 2008 final report
titled ‘‘Refining Cost to Charge Ratios
for Calculating APC and MS–DRG
Relative Payment Weights’’ (https://
www.rti.org/reports/cms/HHSM-5002005-0029I/PDF/Refining_Cost_to_
Charge_Ratios_200807_Final.pdf).
In the FY 2009 IPPS final rule (73 FR
48458 through 48467), in response to
the RTI’s recommendations concerning
cost report refinements, we discussed
our decision to pursue changes to the
cost report to split the cost center for
Medical Supplies Charged to Patients
into one line for ‘‘Medical Supplies
Charged to Patients’’ and another line
for ‘‘Implantable Devices Charged to
Patients.’’ We acknowledged, as RTI had
found, that charge compression occurs
in several cost centers that exist on the
Medicare cost report. However, as we
stated in the FY 2009 IPPS final rule, we
focused on the CCR for Medical
Supplies and Equipment because RTI
found that the largest impact on the
MS–DRG relative weights could result
from correcting charge compression for
devices and implants. In determining
the items that should be reported in
these respective cost centers, we
adopted the commenters’
recommendations that hospitals should
use revenue codes established by the
AHA’s National Uniform Billing
Committee to determine the items that
should be reported in the ‘‘Medical
Supplies Charged to Patients’’ and the
‘‘Implantable Devices Charged to
Patients’’ cost centers. Accordingly, a
new subscripted line for ‘‘Implantable
Devices Charged to Patients’’ was
created in July 2009. This new
subscripted cost center has been
available for use for cost reporting
periods beginning on or after May 1,
2009.
As we discussed in the FY 2009 IPPS
final rule (73 FR 48458) and in the CY
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2009 OPPS/ASC final rule with
comment period (73 FR 68519 through
68527), in addition to the findings
regarding implantable devices, RTI also
found that the costs and charges of
computed tomography (CT) scans,
magnetic resonance imaging (MRI), and
cardiac catheterization differ
significantly from the costs and charges
of other services included in the
standard associated cost center. RTI also
concluded that both the IPPS and the
OPPS relative weights would better
estimate the costs of those services if
CMS were to add standard cost centers
for CT scans, MRIs, and cardiac
catheterization in order for hospitals to
report separately the costs and charges
for those services and in order for CMS
to calculate unique CCRs to estimate the
costs from charges on claims data. In the
FY 2011 IPPS/LTCH PPS final rule (75
FR 50075 through 50080), we finalized
our proposal to create standard cost
centers for CT scans, MRIs, and cardiac
catheterization, and to require that
hospitals report the costs and charges
for these services under new cost
centers on the revised Medicare cost
report Form CMS–2552–10. (We refer
readers to the FY 2011 IPPS/LTCH PPS
final rule (75 FR 50075 through 50080)
for a detailed discussion of the reasons
for the creation of standard cost centers
for CT scans, MRIs, and cardiac
catheterization.) The new standard cost
centers for CT scans, MRIs, and cardiac
catheterization are effective for cost
reporting periods beginning on or after
May 1, 2010, on the revised cost report
Form CMS–2552–10.
In the FY 2009 IPPS final rule (73 FR
48468), we stated that, due to what is
typically a 3-year lag between the
reporting of cost report data and the
availability for use in ratesetting, we
anticipated that we might be able to use
data from the new ‘‘Implantable Devices
Charged to Patients’’ cost center to
develop a CCR for ‘‘Implantable Devices
Charged to Patients’’ in the FY 2012 or
FY 2013 IPPS rulemaking cycle.
However, as noted in the FY 2010 IPPS/
RY 2010 LTCH PPS final rule (74 FR
43782), due to delays in the issuance of
the revised cost report Form CMS 2552–
10, we determined that a new CCR for
‘‘Implantable Devices Charged to
Patients’’ might not be available before
FY 2013. Similarly, when we finalized
the decision in the FY 2011 IPPS/LTCH
PPS final rule to add new cost centers
for CT scans, MRIs, and cardiac
catheterization, we explained that data
from any new cost centers that may be
created will not be available until at
least 3 years after they are first used (75
FR 50077). In preparation for the FY
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2012 IPPS/LTCH PPS rulemaking, we
checked the availability of data in the
‘‘Implantable Devices Charged to
Patients’’ cost center on the FY 2009
cost reports, but we did not believe that
there was a sufficient amount of data
from which to generate a meaningful
analysis in this particular situation.
Therefore, we did not propose to use
data from the ‘‘Implantable Devices
Charged to Patients’’ cost center to
create a distinct CCR for ‘‘Implantable
Devices Charged to Patients’’ for use in
calculating the MS–DRG relative
weights for FY 2012. We indicated that
we would reassess the availability of
data for the ‘‘Implantable Devices
Charged to Patients’’ cost center for the
FY 2013 IPPS/LTCH PPS rulemaking
cycle and, if appropriate, we would
propose to create a distinct CCR at that
time.
During the development of the FY
2013 IPPS/LTCH PPS proposed and
final rules, hospitals were still in the
process of transitioning from the
previous cost report Form CMS–2552–
96 to the new cost report Form CMS–
2552–10. Therefore, we were able to
access only those cost reports in the FY
2010 HCRIS with fiscal year begin dates
on or after October 1, 2009, and before
May 1, 2010; that is, those cost reports
on Form CMS–2552–96. Data from the
Form CMS–2552–10 cost reports were
not available because cost reports filed
on the Form CMS–2552–10 were not
accessible in the HCRIS. Further
complicating matters was that, due to
additional unforeseen technical
difficulties, the corresponding
information regarding charges for
implantable devices on hospital claims
was not yet available to us in the
MedPAR file. Without the breakout in
the MedPAR file of charges associated
with implantable devices to correspond
to the costs of implantable devices on
the cost report, we believed that we had
no choice but to continue computing the
relative weights with the current CCR
that combines the costs and charges for
supplies and implantable devices. We
stated in the FY 2013 IPPS/LTCH PPS
final rule (77 FR 53281 through 53283)
that when we do have the necessary
data for supplies and implantable
devices on the claims in the MedPAR
file to create distinct CCRs for the
respective cost centers for supplies and
implantable devices, we hoped that we
would also have data for an analysis of
creating distinct CCRs for CT scans,
MRIs, and cardiac catheterization,
which could then be finalized through
rulemaking. In the FY 2013 IPPS/LTCH
PPS final rule (77 FR 53281), we stated
that, prior to proposing to create these
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CCRs, we would first thoroughly
analyze and determine the impacts of
the data, and that distinct CCRs for
these new cost centers would be used in
the calculation of the relative weights
only if they were first finalized through
rulemaking.
At the time of the development of the
FY 2014 IPPS/LTCH PPS proposed rule
(78 FR 27506 through 27507), we had a
substantial number of hospitals
completing all, or some, of these new
cost centers on the FY 2011 Medicare
cost reports, compared to prior years.
We stated that we believed that the
analytic findings described using the FY
2011 cost report data and FY 2012
claims data supported our original
decision to break out and create new
cost centers for implantable devices,
MRIs, CT scans, and cardiac
catheterization, and we saw no reason to
further delay proposing to implement
the CCRs of each of these cost centers.
Therefore, beginning in FY 2014, we
proposed a policy to calculate the MS–
DRG relative weights using 19 CCRs,
creating distinct CCRs from cost report
data for implantable devices, MRIs, CT
scans, and cardiac catheterization.
We refer readers to the FY 2014 IPPS/
LTCH PPS proposed rule (78 FR 27507
through 27509) and final rule (78 FR
50518 through 50523) in which we
presented data analyses using distinct
CCRs for implantable devices, MRIs, CT
scans, and cardiac catheterization. The
FY 2014 IPPS/LTCH PPS final rule also
set forth our responses to public
comments we received on our proposal
to implement these CCRs. As explained
in more detail in the FY 2014 IPPS/
LTCH PPS final rule, we finalized our
proposal to use 19 CCRs to calculate
MS–DRG relative weights beginning in
FY 2014—the then existing 15 cost
centers and the 4 new CCRs for
implantable devices, MRIs, CT scans,
and cardiac catheterization. Therefore,
beginning in FY 2014, we calculate the
IPPS MS–DRG relative weights using 19
CCRs, creating distinct CCRs for
implantable devices, MRIs, CT scans,
and cardiac catheterization.
2. Discussion for FY 2016 and Request
for Comments on Nonstandard Cost
Center Codes
Consistent with the policy established
beginning for FY 2014, we calculated
the proposed MS–DRG relative weights
for FY 2016 using two data sources: The
MedPAR file as the claims data source
and the HCRIS as the cost report data
source. We adjusted the charges from
the claims to costs by applying the 19
national average CCRs developed from
the cost reports. The description of the
calculation of the proposed 19 CCRs and
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the proposed MS–DRG relative weights
for FY 2016 is included in section
II.H.3. of the preamble of this proposed
rule.
In preparing to calculate the 19
national average CCRs developed from
the cost reports, we reviewed the HCRIS
data and noticed inconsistencies in
hospitals’ cost reporting and use of
nonstandard cost center codes. In
addition, we discovered that hospitals
typically report the nonstandard codes
with standard cost centers that are
different from the standard cost centers
to which CMS maps and ‘‘rolls up’’ each
nonstandard code in compiling the
HCRIS. We are concerned that
inconsistencies in hospitals’ use of
nonstandard codes, coupled with
differences in the way hospitals and
CMS map these nonstandard codes to
standard lines, may have implications
for the calculation of the 19 CCRs and
the aspects of the IPPS that rely on the
CCRs (for example, the calculation of
the MS–DRG relative weights).
The Medicare cost report Form CMS–
2552–10, Worksheet A, includes
preprinted cost center codes that reflect
the standard cost center descriptions by
category (General Service, Routine, and
Ancillary) used in most hospitals. Each
preprinted standard cost center is
assigned a unique 5-digit code. The
preprinted 5-digit codes provide
standardized meaning for data analysis,
and are automatically coded by CMSapproved cost report software. To
accommodate hospitals that have
additional cost centers that are
sufficiently different from the
preprinted standard cost centers, CMS
identified additional cost centers known
as ‘‘nonstandard’’ cost centers. Each
nonstandard cost center must be labeled
appropriately and reported under a
specific standard cost center. For
example, under the standard cost center
‘‘Electrocardiology’’ with its 5-digit code
of 06900, there are six nonstandard cost
centers (for EKG and EEG,
Electromyography, Cardiopulmonary,
Stress Test, Cardiology, and Holter
Monitor), each with a unique 5-digit
code.
The instructions for the Medicare cost
report Form CMS–2552–10 explain the
purpose and requirements related to the
standard and nonstandard cost centers.
Specifically, in CMS Pub. 15–2, Chapter
40, Section 4013, the instructions for
Worksheet A of Form CMS–2552–10
state:
‘‘Cost center coding is a methodology
for standardizing the meaning of cost
center labels as used by health care
providers on the Medicare cost report.
Form CMS–2552–10 provides for
preprinted cost center descriptions on
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Worksheet A. In addition, a space is
provided for a cost center code. The
preprinted cost center labels are
automatically coded by CMS approved
cost reporting software. These cost
center descriptions are hereafter referred
to as the standard cost centers.
Additionally, nonstandard cost center
descriptions have been identified
through analysis of frequently used
labels.
The use of this coding methodology
allows providers to continue to use
labels for cost centers that have meaning
within the individual institution. The
five digit cost center codes that are
associated with each provider label in
their electronic file provide
standardized meaning for data analysis.
You are required to compare any added
or changed label to the descriptions
offered on the standard or nonstandard
cost center tables. A description of cost
center coding and the table of cost
center codes are in § 4095, Table 5.’’
Section 4095 of CMS Pub. 15–2 (pages
40–805 and 40–806) further provides
that:
‘‘Both the standard and nonstandard
cost center descriptions along with their
cost center codes are shown on Table 5.
. . . Cost center codes may only be used
in designated lines in accordance with
the classification of the cost center(s),
i.e., lines 1 through 23 may only contain
cost center codes within the general
service cost center category of both
standard and nonstandard coding. For
example, in the general service cost
center category for Operation of Plant
cost, line 7 and subscripts thereof
should only contain cost center codes of
00700–00719 and nonstandard cost
center codes. This logic must hold true
for all other cost center categories, i.e.,
ancillary, inpatient routine, outpatient,
other reimbursable, special purpose,
and non- reimbursable cost centers.’’
Table 5 of Section 4095, Chapter 40,
of CMS Pub. 15–2 (pages 40–807
through 40–810) lists the electronic
reporting specifications for each
standard cost center, its 5-digit code,
and, separately, the nonstandard cost
center descriptions and their 5-digit
codes. While the nonstandard codes are
categorized by General Service Cost
Centers, Inpatient Routine Service Cost
Centers, and Ancillary Service Cost
Centers, among others, Table 5 does not
map the nonstandard cost centers and
codes to specific standard cost centers.
In addition, the CMS-approved cost
reporting software does not restrict the
use of nonstandard codes to specific
standard cost centers. Furthermore, the
softwares do not prevent hospitals from
manually entering in a name for a
nonstandard cost center code that may
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be different from the name that CMS
assigned to that nonstandard cost center
code. For example, Table 5 specifies
that the 5-digit code for the Ancillary
Service nonstandard cost center
‘‘Acupuncture’’ is 03020. When CMS
creates the HCRIS SAS files, CMS maps
all codes 03020 to standard line 53,
‘‘Anesthesiology’’.1 However, a review
of the December 31, 2014 update of the
FY 2013 HCRIS SAS files, from which
the proposed 19 CCRs for FY 2016 are
calculated, reveals that, of the 3,172
times that nonstandard code 03020 is
reported by hospitals, it is called
‘‘Acupuncture’’ only 122 times. Instead,
hospitals use various names for
nonstandard code 03020, such as
‘‘Cardiopulmonary,’’ ‘‘Sleep Lab,’’
‘‘Diabetes Center,’’ or ‘‘Wound Care’’.
As noted above, the Ancillary Service
standard cost center for
‘‘Anesthesiology’’, line 53 of Worksheet
A and subsequent worksheets of the
Medicare cost report Form CMS–2552–
10 (and its associated nonstandard cost
center code 03020 ‘‘Acupuncture’’) is an
example of a cost center that is subject
to inconsistent reporting. Our review of
the FY 2013 HCRIS as-submitted cost
reports from which the proposed 19
CCRs for FY 2016 are calculated
revealed that, regardless of the actual
name hospitals assigned to nonstandard
code 03020 (for example,
‘‘Acupuncture’’ or otherwise), hospitals
reported this code almost 100 percent of
the time on standard line 76, ‘‘Other
Ancillary,’’ and never on standard line
53, ‘‘Anesthesiology.’’ Yet, as noted
above, CMS (and previously HCFA,
under earlier versions of the Medicare
cost report), in creating the HCRIS
database, has had the longstanding
practice of mapping and rolling up all
instances of nonstandard code 03020 to
standard line 53, ‘‘Anesthesiology,’’ not
to standard line 76, ‘‘Other Ancillary.
Therefore, the version of the HCRIS SAS
files created by CMS, which CMS uses
for ratesetting purposes, may differ
somewhat from the as-submitted cost
reports of hospitals because CMS moves
various nonstandard cost centers based
on cost center codes, not cost center
descriptions, from the standard cost
centers in which hospitals report them
1 To view how CMS rolls up the codes to create
the HCRIS SAS files, we refer readers to https://
www.cms.gov/Research-Statistics-Data-andSystems/Downloadable-Public-Use-Files/CostReports/Hospital-2010-form.html. On this page,
click on ‘‘Hospital-2010–SAS.ZIP (SAS datasets and
documentation)’’, and from the zip file, choose the
Excel spreadsheet ‘‘2552–10 SAS FILE RECORD
LAYOUT AND CROSSWALK TO 96.xlsx’’. The
second tab of this spreadsheet is ‘‘NEW ROLLUPS’’,
and shows the standard and nonstandard 5-digit
codes (columns B and C) that CMS rolls up to each
standard line (column G).
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and places them in different standard
cost centers based on CMS’ roll-up
specifications.
We are highlighting the discrepancy
in the reporting of nonstandard code
03020 ‘‘Acupuncture’’ because the
placement of nonstandard code 03020
and its related costs and charges seem
to have the most significant
implications for the calculation of one
of the 19 CCRs, the Anesthesia CCR. As
stated in section II.H.3. of the preamble
of this proposed rule, the proposed FY
2016 CCR for Anesthesia is 0.108. We
calculated this proposed CCR based on
the December 31, 2014 update of the FY
2013 HCRIS, with the nonstandard cost
center codes of 03020 through 03029
rolled up to standard line 53,
‘‘Anesthesiology.’’ That is, under the
CMS’ HCRIS specifications, we roll up
the following 5-digit codes to standard
line 53, ‘‘Anesthesiology’’: 2 standard
codes for ‘‘Anesthesiology’’ 05300
through 05329; and nonstandard codes
for ‘‘Acupuncture ’’ 03020 through
03029. For simulation purposes, we also
created a version of the December 31,
2014 update of the FY 2013 HCRIS
which retains nonstandard codes 03020
through 03029 on standard line 76,
‘‘Other Ancillary,’’ where hospitals
actually reported these codes on their
as-submitted FY 2013 cost reports.
When all reported uses of nonstandard
codes 03020 through 03029 remain on
standard line 76, ‘‘Other Ancillary,’’ we
calculated that the Anesthesia CCR
would be 0.084 (instead of 0.108 as
proposed in section II.H.3. of the
preamble of this proposed rule). We also
looked at the effect on the other 18
CCRs. In the version of HCRIS we
created for simulation purposes, by
keeping the nonstandard cost center
codes in standard line 76, ‘‘Other
Ancillary,’’ where hospitals typically
report them, rather than remapping
them according to CMS specifications,
two other CCRs also are affected,
although not quite as significantly as the
Anesthesia CCR. Currently, as proposed
in section II.H.3. of the preamble of this
proposed rule, the proposed FY 2016
Cardiology CCR is 0.119, but when all
cardiology-related nonstandard codes
are rolled up to standard line 76, ‘‘Other
Ancillary’’, and not to standard line 69,
‘‘Electrocardiology’’ as under CMS’
usual practice, the Cardiology CCR
would be 0.113. In addition, as
proposed in section II.H.3. of the
preamble of this proposed rule, the
proposed FY 2016 Radiology CCR is
0.159, but when all radiology-related
nonstandard codes are rolled up to
standard line 76, ‘‘Other Ancillary’’, and
2 Ibid.
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not to standard lines 54 (Radiology—
Diagnostic), 55 (Radiology—
Therapeutic), and 56 (Radioisotope) as
under CMS’ usual practice, the
Radiology CCR would be 0.161. Most
notably, the CCR that is most impacted
is the ‘‘Other Services’’ CCR. Currently,
as proposed in section II.H.3. of the
preamble of this proposed rule, the
‘‘Other Services’’ CCR is 0.367.
However, if all nonstandard cost center
codes would remain in line 76, ‘‘Other
Ancillary’’ as hospitals have reported
them in their FY 2013 as-submitted cost
reports, instead of CMS applying its
usual practice of rolling up these lines
to the applicable ‘‘Electrocardiology’’
and ‘‘Radiology’’ standard cost centers,
among others, the ‘‘Other Services’’ CCR
would be 0.291. We note that we
observed minimal or no differences in
the remaining 15 CCRs, when their
associated nonstandard cost centers
were rolled up to their specific standard
cost centers, versus being rolled up to
the standard line 76, ‘‘Other Ancillary.’’
The differences in these CCRs
computed from the HCRIS that was
compiled by applying CMS’ current
rollup procedures of assigning
nonstandard codes to specific standard
cost centers, as compared to following
hospitals’ general practice of reporting
nonstandard codes ‘‘en masse’’ on line
76, ‘‘Other Ancillary,’’ have
implications for the aspects of the IPPS
that rely on the CCRs (for example, the
calculation of the MS–DRG relative
weights). Some questions that arise are
whether CMS’ procedures for mapping
and rolling up nonstandard cost centers
to specific standard cost centers should
be updated or whether hospital
reporting practices are imprecise, or
whether there is a combination of both.
CMS’ rollup procedures were developed
many years ago based on historical
analysis of hospitals’ cost reporting
practices and health care services
furnished. It may be that it would be
appropriate for CMS to reevaluate its
rollup procedures based on hospitals’
more current cost reporting practices
and contemporary health care services
provided. However, one factor
complicating the determination of the
most accurate standard cost centers to
which each respective nonstandard cost
center should be mapped is hospitals’
own inconsistent reporting practices.
For example, it may be determined that
CMS should no longer be mapping and
rolling up nonstandard cost center
‘‘Acupuncture’’ and its associated 5digit codes 03020 through 03029 to
standard cost center line 53,
‘‘Anesthesiology.’’ However,
determining which other standard line
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‘‘Acupuncture’’ and its associated 5digit codes 03020 through 03029 should
be mapped is unclear, given that, as
mentioned above, out of the 3,172 times
that codes 03020 through 03029 were
reported in the FY 2013 HCRIS file,
hospitals called these codes
‘‘Acupuncture’’ only 122 times, and
instead called these codes a variety of
other names (such as Cardiopulmonary,
Sleep Lab, Wound Care, Diabetes
Center, among others). Therefore,
without being able to determine the true
nature of the services that were actually
provided, it is difficult to know which
standard cost center to map these
services. That is, the question arises as
to whether the service provided was
acupuncture because a hospital reported
code 03020, or whether the service
provided was cardiopulmonary, which
was the name a hospital assigned to
code 03020. Furthermore, if the service
provided was in fact cardiopulmonary,
then, as Table 5 of Section 4095 of CMS
Pub. 15–2 indicates, the correct
nonstandard code for cardiopulmonary
is 03160, not 03020. A related question
would then be, if the hospital provided
cardiopulmonary services, which are
clearly related to cardiology, why did
the hospital report those costs and
charges on line 76, ‘‘Other Ancillary,’’
instead of subscripting standard line 69,
‘‘Electrocardiology,’’ and reporting the
cardiopulmonary costs and charges
there.
In summary, we believe that the
differences between the standard cost
centers to which CMS assigns
nonstandard codes when CMS rolls up
cost report data to create the HCRIS SAS
database, and the standard cost centers
to which hospitals tend to assign and
use nonstandard codes, coupled with
the inconsistencies found in hospitals’
use and naming of the nonstandard
codes, have implications for the aspects
of the IPPS that rely on the CCRs. For
example, we have explained above and
provided examples of how the CCRs
used to calculate the MS–DRG relative
weights could change, based on where
certain nonstandard codes are reported
and rolled up in the cost reports.
However, before considering changes to
our longstanding practices, we are
interested in receiving public comments
from stakeholders as to how to improve
the use of nonstandard cost center
codes. One option might be for CMS to
allow only certain nonstandard codes to
be used with certain standard cost
centers, meaning that CMS might
require that the CMS-approved cost
reporting softwares ‘‘lock in’’ those
nonstandard codes with their assigned
standard cost centers. For example, if a
hospital wishes to subscript a standard
cost center, the cost reporting software
might allow the hospital to choose only
from a predetermined set of
nonstandard codes. Therefore, for
example, if a hospital wished to report
Cardiopulmonary costs and charges on
its cost report, the only place that the
hospital could do that under this
approach would be from a drop down
list of cardiology-related services on
standard line 69, ‘‘Electrocardiology,’’
and not on another line (not even line
76, ‘‘Other Ancillary’’). Some flexibility
could be maintained, but within certain
limits, in consideration of unique
services that hospitals might provide.
In the interim, while we seek public
comments on this issue, we have
proposed 19 CCRs for FY 2016 (listed in
section II.H.3. of the preamble of this
proposed rule) that were calculated
from the December 31, 2014 update of
the FY 2013 HCRIS, created in
accordance with CMS’ current
longstanding procedures for mapping
and rolling up nonstandard cost center
codes. As we did with the FY 2015
IPPS/LTCH PPS final rule, we are
providing the version of the HCRIS from
which we calculated these proposed 19
CCRs on the FY 2016 IPPS Proposed
Rule Home Page at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/FY2016-IPPSProposed-Rule-Home-Page.html.3
F. Proposed Adjustment to MS–DRGs for
Preventable Hospital-Acquired
Conditions (HACs), Including Infections
for FY 2016
1. Background
Section 1886(d)(4)(D) of the Act
addresses certain hospital-acquired
conditions (HACs), including infections.
This provision is part of an array of
Medicare tools that we are using to
promote increased quality and
efficiency of care. Under the IPPS,
hospitals are encouraged to treat
patients efficiently because they receive
the same DRG payment for stays that
vary in length and in the services
provided, which gives hospitals an
incentive to avoid unnecessary costs in
the delivery of care. In some cases,
conditions acquired in the hospital do
not generate higher payments than the
hospital would otherwise receive for
cases without these conditions. To this
extent, the IPPS encourages hospitals to
avoid complications.
However, the treatment of these
conditions can generate higher Medicare
payments in two ways. First, if a
hospital incurs exceptionally high costs
treating a patient, the hospital stay may
generate an outlier payment. However,
because the outlier payment
methodology requires that hospitals
experience large losses on outlier cases
before outlier payments are made,
hospitals have an incentive to prevent
outliers. Second, under the MS–DRG
system that took effect in FY 2008 and
that has been refined through
rulemaking in subsequent years, certain
conditions can generate higher
payments even if the outlier payment
requirements are not met. Under the
MS–DRG system, there are currently 261
sets of MS–DRGs that are split into 2 or
3 subgroups based on the presence or
absence of a complication or
comorbidity (CC) or a major
complication or comorbidity (MCC).
The presence of a CC or an MCC
generally results in a higher payment.
Section 1886(d)(4)(D) of the Act
specifies that, by October 1, 2007, the
Secretary was required to select, in
consultation with the Centers for
Disease Control and Prevention (CDC),
at least two conditions that: (a) Are high
cost, high volume, or both; (b) are
assigned to a higher paying MS–DRG
when present as a secondary diagnosis
(that is, conditions under the MS–DRG
system that are CCs or MCCs); and (c)
could reasonably have been prevented
through the application of evidencebased guidelines. Section 1886(d)(4)(D)
of the Act also specifies that the list of
conditions may be revised, again in
consultation with the CDC, from time to
time as long as the list contains at least
two conditions.
Effective for discharges occurring on
or after October 1, 2008, under the
authority of section 1886(d)(4)(D) of the
Act, Medicare no longer assigns an
inpatient hospital discharge to a higher
paying MS–DRG if a selected condition
is not present on admission (POA).
Thus, if a selected condition that was
not POA manifests during the hospital
stay, it is considered a HAC and the case
is paid as though the secondary
diagnosis was not present. However,
even if a HAC manifests during the
hospital stay, if any nonselected CC or
MCC appears on the claim, the claim
will be paid at the higher MS–DRG rate.
In addition, Medicare continues to
assign a discharge to a higher paying
MS–DRG if a selected condition is POA.
When a HAC is not POA, payment can
be affected in a manner shown in the
diagram below.
3 Ibid.
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FR 50523 through 50527), and the FY
2015 IPPS/LTCH PPS proposed rule (79
FR 28000 through 28003) and final rule
(79 FR 49876 through 49880). A
complete list of the 11 current categories
of HACs is included on the CMS Web
site at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HospitalAcqCond/Hospital-Acquired_
Conditions.html.
3. Present on Admission (POA)
Indicator Reporting
Collection of POA indicator data is
necessary to identify which conditions
were acquired during hospitalization for
the HAC payment provision as well as
for broader public health uses of
Medicare data. In previous rulemaking,
we provided both CMS and CDC Web
site resources that are available to
hospitals for assistance in this reporting
effort. For detailed information
regarding these sites and materials,
including the application and use of
POA indicators, we refer the reader to
the FY 2012 IPPS/LTCH PPS final rule
(76 FR 51506 through 51507).
Currently, as we have discussed in the
prior rulemaking cited under section
II.I.2. of the preamble of this proposed
rule, the POA indicator reporting
requirement only applies to IPPS
hospitals and Maryland hospitals
because they are subject to this HAC
provision. Non-IPPS hospitals,
including CAHs, LTCHs, IRFs, IPFs,
cancer hospitals, children’s hospitals,
RNHCIs, and the Department of
Veterans Affairs/Department of Defense
hospitals, are exempt from POA
reporting.
There are currently four POA
indicator reporting options, ‘‘Y’’, ‘‘W’’,
‘‘N’’, and ‘‘U’’, as defined by the ICD–
9–CM Official Guidelines for Coding
and Reporting. We note that prior to
January 1, 2011, we also used a POA
indicator reporting option ‘‘1’’.
However, beginning on or after January
1, 2011, hospitals were required to begin
reporting POA indicators using the 5010
electronic transmittal standards format.
The 5010 format removes the need to
report a POA indicator of ‘‘1’’ for codes
that are exempt from POA reporting. We
issued CMS instructions on this
reporting change as a One-Time
Notification, Pub. No. 100–20,
Transmittal No. 756, Change Request
7024, effective on August 13, 2010,
which can be located at the following
link on the CMS Web site: https://
www.cms.gov/manuals/downloads/
Pub100_20.pdf. The current POA
indicators and their descriptors are
shown in the chart below:
Indicator
Descriptor
Y ....................
W ...................
Indicates that the condition was present on admission.
Affirms that the hospital has determined that, based on data and clinical judgment, it is not possible to document when the
onset of the condition occurred.
Indicates that the condition was not present on admission.
Indicates that the documentation is insufficient to determine if the condition was present at the time of admission.
N ...................
U ...................
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2. HAC Selection
Beginning in FY 2007, we have set
forth proposals, and solicited and
responded to public comments, to
implement section 1886(d)(4)(D) of the
Act through the IPPS annual rulemaking
process. For specific policies addressed
in each rulemaking cycle, including a
detailed discussion of the collaborative
interdepartmental process and public
input regarding selected and potential
candidate HACs, we refer readers to the
following rules: The FY 2007 IPPS
proposed rule (71 FR 24100) and final
rule (71 FR 48051 through 48053); the
FY 2008 IPPS proposed rule (72 FR
24716 through 24726) and final rule
with comment period (72 FR 47200
through 47218); the FY 2009 IPPS
proposed rule (73 FR 23547) and final
rule (73 FR 48471); the FY 2010 IPPS/
RY 2010 LTCH PPS proposed rule (74
FR 24106) and final rule (74 FR 43782);
the FY 2011 IPPS/LTCH PPS proposed
rule (75 FR 23880) and final rule (75 FR
50080); the FY 2012 IPPS/LTCH PPS
proposed rule (76 FR 25810 through
25816) and final rule (76 FR 51504
through 51522); the FY 2013 IPPS/LTCH
PPS proposed rule (77 FR 27892
through 27898) and final rule (77 FR
53283 through 53303); the FY 2014
IPPS/LTCH PPS proposed rule (78 FR
27509 through 27512) and final rule (78
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Under the HAC payment policy, we
treat HACs coded with ‘‘Y’’ and ‘‘W’’
indicators as POA and allow the
condition on its own to cause an
increased payment at the CC and MCC
level. We treat HACs coded with ‘‘N’’
and ‘‘U’’ indicators as Not Present on
Admission (NPOA) and do not allow the
condition on its own to cause an
increased payment at the CC and MCC
level. We refer readers to the following
rules for a detailed discussion of POA
indicator reporting: the FY 2009 IPPS
proposed rule (73 FR 23559) and final
rule (73 FR 48486 through 48487); the
FY 2010 IPPS/RY 2010 LTCH PPS
proposed rule (74 FR 24106) and final
rule (74 FR 43784 through 43785); the
FY 2011 IPPS/LTCH PPS proposed rule
(75 FR 23881 through 23882) and final
rule (75 FR 50081 through 50082); the
FY 2012 IPPS/LTCH PPS proposed rule
(76 FR 25812 through 25813) and final
rule (76 FR 51506 through 51507); the
FY 2013 IPPS/LTCH PPS proposed rule
(77 FR 27893 through 27894) and final
rule (77 FR 53284 through 53285); the
FY 2014 IPPS/LTCH PPS proposed rule
(78 FR 27510 through 27511) and final
rule (78 FR 50524 through 50525), and
the FY 2015 IPPS/LTCH PPS proposed
rule (79 FR 28001 through 28002) and
final rule (79 FR 49877 through 49878).
In addition, as discussed previously
in the FY 2013 IPPS/LTCH PPS final
rule (77 FR 53324), the 5010 format
allows the reporting and, effective
January 1, 2011, the processing of up to
25 diagnoses and 25 procedure codes.
As such, it is necessary to report a valid
POA indicator for each diagnosis code,
including the principal diagnosis and
all secondary diagnoses up to 25.
4. HACs and POA Reporting in
Preparation for Transition to ICD–10–
CM and ICD–10–PCS
In the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51506 and 51507), in
preparation for the transition to the
ICD–10–CM and ICD–10–PCS code sets,
we indicated that further information
regarding the use of the POA indicator
with the ICD–10–CM/ICD–10–PCS
classifications as they pertain to the
HAC policy would be discussed in
future rulemaking.
At the March 5, 2012 and the
September 19, 2012 meetings of the
ICD–9–CM Coordination and
Maintenance Committee, an
announcement was made with regard to
the availability of the ICD–9–CM HAC
list translation to ICD–10–CM and ICD–
10–PCS code sets. Participants were
informed that the list of the ICD–9–CM
selected HACs had been translated into
codes using the ICD–10–CM and ICD–
10–PCS classification system. It was
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recommended that the public review
this list of ICD–10–CM/ICD–10–PCS
code translations of the selected HACs
available on the CMS Web site at:
https://www.cms.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html. We encouraged the public
to submit comments on these
translations through the HACs Web page
using the CMS ICD–10–CM/PCS HAC
Translation Feedback Mailbox that was
set up for this purpose under the
Related Links section titled ‘‘CMS HAC
Feedback.’’ We also encouraged readers
to review the educational materials and
draft code sets available for ICD–10–
CM/PCS on the CMS Web site at:
https://www.cms.gov/ICD10/. Lastly, we
provided information regarding the
ICD–10 MS–DRG Conversion Project on
the CMS Web site at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalAcqCond/
icd10_hacs.html.
In the FY 2014 IPPS/LTCH PPS final
rule (78 FR 50525), we stated that the
final HAC list translation from ICD–9–
CM to ICD–10–CM/ICD–10–PCS would
be subject to formal rulemaking. We
again encouraged readers to review the
educational materials and updated draft
code sets available for ICD–10–CM/ICD–
10–PCS on the CMS Web site at:
https://www.cms.gov/ICD10/. In
addition, we stated that the draft ICD–
10–CM Coding Guidelines could be
viewed on the CDC Web site at: https://
www.cdc.gov/nchs/icd/icd10cm.htm.
However, prior to engaging in
rulemaking for the FY 2015 HAC
program, on April 1, 2014, the
Protecting Access to Medicare Act of
2014 (PAMA) (Pub. L. 113–93) was
enacted, which specified that the
Secretary may not adopt ICD–10 prior to
October 1, 2015. Accordingly, the U.S.
Department of Health and Human
Services released a final rule in the
Federal Register on August 4, 2014 (79
FR 45128 through 45134) that included
a new compliance date that requires the
use of ICD–10 beginning October 1,
2015. The August 4, 2014 final rule is
available for viewing on the Internet at:
https://www.gpo.gov/fdsys/pkg/FR-201408-04/pdf/2014-18347.pdf. That final
rule also requires HIPAA covered
entities to continue to use ICD–9–CM
through September 30, 2015. Further
information of the ICD–10 rules can be
found on the Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
Statute_Regulations.html.
As described in section II.F.5. of the
preamble of this proposed rule, we are
proposing the HAC list translation from
ICD–9–CM to ICD–10–CM/ICD–10–PCS
in this FY 2016 IPPS/LTCH PPS
proposed rule.
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5. Proposed Changes to the HAC
Program for FY 2016
As discussed in section II.G. 1. a. of
the preamble of this proposed rule, for
FY 2016, we are proposing the ICD–10
MS–DRGs Version 33 as the
replacement logic for the ICD–9–CM
MS–DRGs Version 32. As part of our
DRA HAC update for FY 2016, we are
proposing that the ICD–10–CM/PCS
Version 33 HAC list replace the ICD–9–
CM Version 32 HAC list. We are
soliciting public comments on how well
the ICD–10–CM/PCS Version 32 HAC
list replicates the ICD–9–CM Version 32
HAC list.
CMS prepared the ICD–10 MS–DRGs
Version 32 based on the FY 2015 MS–
DRGs (Version 32) that we finalized in
the FY 2015 IPPS/LTCH PPS final rule.
In November 2014, we posted a
Definitions Manual of the ICD–10 MS–
DRGs Version 32 on the ICD–10 MS–
DRG Conversion Project Web site at:
https://www.cms.hhs.gov/Medicare/
Coding/ICD10/ICD-10-MS-DRGConversion-Project.html. The HAC code
list translations from ICD–9–CM to ICD–
10–CM/PCS are located in Appendix I
of the ICD–10–CM/PCS MS–DRG
Version 32 Definitions Manual. The link
to this Manual (available in both text
and HTML formats) is located in the
Downloads section of the ICD–10 MS–
DRG Conversion Project Web site.
With respect to the current categories
of the HACs, we are not proposing to
add or remove any categories in this FY
2016 IPPS/LTCH PPS proposed rule.
However, as described more fully in
section III.F.7, of the preamble of this
proposed rule, we will continue to
monitor contemporary evidence-based
guidelines for selected, candidate, and
previously considered HACs that
provide specific recommendations for
the prevention of the corresponding
conditions in the acute hospital setting
and may use this information to inform
future rulemaking. We also continue to
encourage public dialogue about
refinements to the HAC list through
written stakeholder comments. We refer
readers to section II.F.6. of the FY 2008
IPPS final rule with comment period (72
FR 47202 through 47218) and to section
II.F.7. of the FY 2009 IPPS final rule (73
FR 48774 through 48491) for detailed
discussion supporting our
determination regarding each of the
current conditions. We also refer readers
to the FY 2013 IPPS/LTCH PPS
proposed rule (77 FR 27892 through
27898) and final rule (77 FR 53285
through 53292) for the HAC policy for
FY 2013, the FY 2014 IPPS/LTCH PPS
proposed rule (78 FR 27509 through
27512) and final rule (78 FR 50523
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through 50527) for the HAC policy for
FY 2014, and the FY 2015 IPPS/LTCH
PPS proposed rule (79 FR 28000
through 28003) and final rule (79 FR
49876 through 49880) for the HAC
policy for FY 2015.
In summary, we are proposing that
the ICD–10–CM/PCS Version 33 HAC
list replace the ICD–9–CM Version 32
HAC list and are seeking public
comments on how well the ICD–10–CM/
PCS Version 32 HAC list replicates the
ICD–9–CM Version 32 HAC list.
6. RTI Program Evaluation
On September 30, 2009, a contract
was awarded to RTI to evaluate the
impact of the Hospital-Acquired
Condition-Present on Admission (HAC–
POA) provisions on the changes in the
incidence of selected conditions, effects
on Medicare payments, impacts on
coding accuracy, unintended
consequences, and infection and event
rates. This was an intra-agency project
with funding and technical support
from CMS, OPHS, AHRQ, and CDC. The
evaluation also examined the
implementation of the program and
evaluated additional conditions for
future selection. The contract with RTI
ended on November 30, 2012. Summary
reports of RTI’s analysis of the FYs
2009, 2010, and 2011 MedPAR data files
for the HAC–POA program evaluation
were included in the FY 2011 IPPS/
LTCH PPS final rule (75 FR 50085
through 50101), the FY 2012 IPPS/LTCH
PPS final rule (76 FR 51512 through
51522), and the FY 2013 IPPS/LTCH
PPS final rule (77 FR 53292 through
53302). Summary and detailed data also
were made publicly available on the
CMS Web site at: https://www.cms.gov/
HospitalAcqCond/01_Overview.asp and
the RTI Web site at: https://www.rti.org/
reports/cms/.
In addition to the evaluation of HAC
and POA MedPAR claims data, RTI also
conducted analyses on readmissions
due to HACs, the incremental costs of
HACs to the health care system, a study
of spillover effects and unintended
consequences, as well as an updated
analysis of the evidence-based
guidelines for selected and previously
considered HACs. Reports on these
analyses have been made publicly
available on the CMS Web site at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HospitalAcqCond/.
7. RTI Reports on Evidence-Based
Guidelines
The RTI program evaluation included
a report that provided references for all
evidence-based guidelines available for
each of the selected, candidate, and
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previously considered HACs that
provided specific recommendations for
the prevention of the corresponding
conditions. Guidelines were primarily
identified using the AHRQ National
Guidelines Clearing House (NGCH) and
the CDC, along with relevant
professional societies. Guidelines
published in the United States were
used, if available. In the absence of U.S.
guidelines for a specific condition,
international guidelines were included.
RTI prepared a final report to
summarize its findings regarding these
guidelines. This report is titled
‘‘Evidence-Based Guidelines for
Selected, Candidate, and Previously
Considered Hospital-Acquired
Conditions’’ and can be found on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/HospitalAcqCond/Downloads/
Evidence-Based-Guidelines.pdf.
Subsequent to this final report, RTI
was awarded a new Evidence-Based
Guidelines Monitoring contract. Under
this monitoring contract, RTI annually
provides a summary report of the
contemporary evidence-based
guidelines for selected, candidate, and
previously considered HACs that
provide specific recommendations for
the prevention of the corresponding
conditions in the acute care hospital
setting. We received RTI’s 2014 report
and made it available to the public on
the CMS Hospital-Acquired Conditions
Web page in the ‘‘Downloads’’ section
at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HospitalAcqCond/?redirect=/
HospitalAcqCond/.
Once we receive RTI’s 2015 report in
the late spring or early summer, we will
make it available to the public at this
same link as the 2014 report.
G. Proposed Changes to Specific MS–
DRG Classifications
1. Discussion of Changes to Coding
System and Basis for MS–DRG Updates
a. Conversion of MS–DRGs to the
International Classification of Diseases,
10th Revision (ICD–10)
Providers use the code sets under the
ICD–9–CM coding system to report
diagnoses and procedures for Medicare
hospital inpatient services under the
MS–DRG system. A later coding edition,
the ICD–10 coding system, includes the
International Classification of Diseases,
10th Revision, Clinical Modification
(ICD–10–CM) for diagnosis coding and
the International Classification of
Diseases, 10th Revision, Procedure
Coding System (ICD–10–PCS) for
inpatient hospital procedure coding, as
well as the Official ICD–10–CM and
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ICD–10–PCS Guidelines for Coding and
Reporting. The ICD–10 coding system
was initially adopted for transactions
conducted on or after October 1, 2013,
as described in the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) Administrative
Simplification: Modifications to
Medical Data Code Set Standards to
Adopt ICD–10–CM and ICD–10–PCS
Final Rule published in the Federal
Register on January 16, 2009 (74 FR
3328 through 3362) (hereinafter referred
to as the ‘‘ICD–10–CM and ICD–10–PCS
final rule’’). However, the Secretary of
Health and Human Services issued a
final rule that delayed the compliance
date for ICD–10 from October 1, 2013,
to October 1, 2014. That final rule,
entitled ‘‘Administrative Simplification:
Adoption of a Standard for a Unique
Health Plan Identifier; Addition to the
National Provider Identifier
Requirements; and a Change to the
Compliance Date for ICD–10–CM and
ICD–10–PCS Medical Data Code Sets,’’
CMS–0040–F, was published in the
Federal Register on September 5, 2012
(77 FR 54664) and is available for
viewing on the Internet at: https://
www.gpo.gov/fdsys/pkg/FR-2012-09-05/
pdf/2012-21238.pdf. On April 1, 2014,
the Protecting Access to Medicare Act of
2014 (PAMA) (Pub. L. 113–93) was
enacted, which specified that the
Secretary may not adopt ICD–10 prior to
October 1, 2015. Accordingly, the U.S.
Department of Health and Human
Services released a final rule in the
Federal Register on August 4, 2014 (79
FR 45128 through 45134) that included
a new compliance date that requires the
use of ICD–10 beginning October 1,
2015. The August 4, 2014 final rule is
available for viewing on the Internet at:
https://www.gpo.gov/fdsys/pkg/FR-201408-04/pdf/2014-18347.pdf. That final
rule also requires HIPAA covered
entities to continue to use ICD–9–CM
through September 30, 2015.
The anticipated move to ICD–10
necessitated the development of an
ICD–10–CM/ICD–10–PCS version of the
MS–DRGs. CMS began a project to
convert the ICD–9–CM-based MS–DRGs
to ICD–10 MS–DRGs. In response to the
FY 2011 IPPS/LTCH PPS proposed rule,
we received public comments on the
creation of the ICD–10 version of the
MS–DRGs, which will be implemented
at the same time as ICD–10 (75 FR
50127 and 50128). While we did not
propose an ICD–10 version of the MS–
DRGs in the FY 2011 IPPS/LTCH PPS
proposed rule, we noted that we have
been actively involved in converting
current MS–DRGs from ICD–9–CM
codes to ICD–10 codes and sharing this
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information through the ICD–10
(previously ICD–9–CM) Coordination
and Maintenance Committee. We
undertook this early conversion project
to assist other payers and providers in
understanding how to implement their
own conversion projects. We posted
ICD–10 MS–DRGs based on Version
26.0 (FY 2009) of the MS–DRGs. We
also posted a paper that describes how
CMS went about completing this project
and suggestions for other payers and
providers to follow. Information on the
ICD–10 MS–DRG conversion project can
be found on the ICD–10 MS–DRG
Conversion Project Web site at: https://
www.cms.hhs.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html. We have continued to keep
the public updated on our maintenance
efforts for ICD–10–CM and ICD–10–PCS
coding systems, as well as the General
Equivalence Mappings that assist in
conversion through the ICD–10
(previously ICD–9–CM) Coordination
and Maintenance Committee.
Information on these committee
meetings can be found on the CMS Web
site at: https://www.cms.gov/Medicare/
Coding/ICD9ProviderDiagnosticCodes/
index.html.
During FY 2011, we developed and
posted Version 28 of the ICD–10 MS–
DRGs based on the FY 2011 MS–DRGs
(Version 28) that we finalized in the FY
2011 IPPS/LTCH PPS final rule on the
CMS Web site. This ICD–10 MS–DRGs
Version 28 also included the CC
Exclusion List and the ICD–10 version
of the hospital-acquired conditions
(HACs), which was not posted with
Version 26. We also discussed this
update at the September 15–16, 2010
and the March 9–10, 2011 meetings of
the ICD–9–CM Coordination and
Maintenance Committee. The minutes
of these two meetings are posted on the
CMS Web site at: https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/
index.html.
We reviewed public comments on the
ICD–10 MS–DRGs Version 28 and made
updates as a result of these comments.
We called the updated version the ICD–
10 MS–DRGs Version 28–R1. We posted
a Definitions Manual of ICD–10 MS–
DRGs Version 28–R1 on our ICD–10
MS–DRG Conversion Project Web site.
To make the review of Version 28–R1
updates easier for the public, we also
made available pilot software on a CD–
ROM that could be ordered through the
National Technical Information Service
(NTIS). A link to the NTIS ordering page
was provided on the CMS ICD–10 MS–
DRGs Web page. We stated that we
believed that, by providing the ICD–10
MS–DRGs Version 28–R1 Pilot Software
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(distributed on CD–ROM), the public
would be able to more easily review and
provide feedback on updates to the ICD–
10 MS–DRGs. We discussed the updated
ICD–10 MS–DRGs Version 28–R1 at the
September 14, 2011 ICD–9–CM
Coordination and Maintenance
Committee meeting. We encouraged the
public to continue to review and
provide comments on the ICD–10 MS–
DRGs so that CMS could continue to
update the system.
In FY 2012, we prepared the ICD–10
MS–DRGs Version 29, based on the FY
2012 MS–DRGs (Version 29) that we
finalized in the FY 2012 IPPS/LTCH
PPS final rule. We posted a Definitions
Manual of ICD–10 MS–DRGs Version 29
on our ICD–10 MS–DRG Conversion
Project Web site. We also prepared a
document that describes changes made
from Version 28 to Version 29 to
facilitate a review. The ICD–10 MS–
DRGs Version 29 was discussed at the
ICD–9–CM Coordination and
Maintenance Committee meeting on
March 5, 2012. Information was
provided on the types of updates made.
Once again, the public was encouraged
to review and comment on the most
recent update to the ICD–10 MS–DRGs.
CMS prepared the ICD–10 MS–DRGs
Version 30 based on the FY 2013 MS–
DRGs (Version 30) that we finalized in
the FY 2013 IPPS/LTCH PPS final rule.
We posted a Definitions Manual of the
ICD–10 MS–DRGs Version 30 on our
ICD–10 MS–DRG Conversion Project
Web site. We also prepared a document
that describes changes made from
Version 29 to Version 30 to facilitate a
review. We produced mainframe and
computer software for Version 30,
which was made available to the public
in February 2013. Information on
ordering the mainframe and computer
software through NTIS was posted on
the ICD–10 MS–DRG Conversion Project
Web site. The ICD–10 MS–DRGs
Version 30 computer software facilitated
additional review of the ICD–10 MS–
DRGs conversion.
We provided information on a study
conducted on the impact of converting
MS–DRGs to ICD–10. Information on
this study is summarized in a paper
entitled ‘‘Impact of the Transition to
ICD–10 on Medicare Inpatient Hospital
Payments.’’ This paper was posted on
the CMS ICD–10 MS–DRGs Conversion
Project Web site and was distributed
and discussed at the September 15, 2010
ICD–9–CM Coordination and
Maintenance Committee meeting. The
paper described CMS’ approach to the
conversion of the MS–DRGs from ICD–
9–CM codes to ICD–10 codes. The study
was undertaken using the ICD–9–CM
MS–DRGs Version 27 (FY 2010), which
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was converted to the ICD–10 MS–DRGs
Version 27. The study estimated the
impact on aggregate payment to
hospitals and the distribution of
payments across hospitals. The impact
of the conversion from ICD–9–CM to
ICD–10 on Medicare MS–DRG hospital
payments was estimated using FY 2009
Medicare claims data. The study found
a hospital payment increase of 0.05
percent using the ICD–10 MS–DRGs
Version 27.
CMS provided an overview of this
hospital payment impact study at the
March 5, 2012 ICD–9–CM Coordination
and Maintenance Committee meeting.
This presentation followed
presentations on the creation of ICD–10
MS–DRGs Version 29. A summary
report of this meeting can be found on
the CMS Web site at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/
index.html. At the March 2012 meeting,
CMS announced that it would produce
an update on this impact study based on
an updated version of the ICD–10 MS–
DRGs. This update of the impact study
was presented at the March 5, 2013
ICD–9–CM Coordination and
Maintenance Committee meeting. The
study found that moving from an ICD–
9–CM-based system to an ICD–10 MS–
DRG replicated system would lead to
DRG reassignments on only 1 percent of
the 10 million MedPAR sample records
used in the study. Ninety-nine percent
of the records did not shift to another
MS–DRG when using an ICD–10 MS–
DRG system. For the 1 percent of the
records that shifted, 45 percent of the
shifts were to a higher weighted MS–
DRG, while 55 percent of the shifts were
to lower weighted MS–DRGs. The net
impact across all MS–DRGs was a
reduction by 4/10000 or minus 4
pennies per $100. The updated paper is
posted on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
ICD-10-MS-DRG-ConversionProject.html under the ‘‘Downloads’’
section. Information on the March 5,
2013 ICD–9–CM Coordination and
Maintenance Committee meeting can be
found on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
This update of the impact paper and the
ICD–10 MS–DRG Version 30 software
provided additional information to the
public who were evaluating the
conversion of the MS–DRGs to ICD–10
MS–DRGs.
CMS prepared the ICD–10 MS–DRGs
Version 31.0 based on the FY 2014 MS–
DRGs (Version 31) that we finalized in
the FY 2014 IPPS/LTCH PPS final rule.
In November 2013, we posted a
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Definitions Manual of the ICD–10 MS–
DRGs Version 31 on the ICD–10 MS–
DRG Conversion Project Web site at:
https://www.cms.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html. We also prepared a
document that described changes made
from Version 30 to Version 31 to
facilitate a review. We produced
mainframe and computer software for
Version 31, which was made available
to the public in December 2013.
Information on ordering the mainframe
and computer software through NTIS
was posted on the CMS Web site at:
https://www.cms.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html under the ‘‘Related Links’’
section. This ICD–10 MS–DRGs Version
31 computer software facilitated
additional review of the ICD–10 MS–
DRGs conversion. We encouraged the
public to submit to CMS any comments
on areas where they believed the ICD–
10 MS–DRGs did not accurately reflect
grouping logic found in the ICD–9–CM
MS–DRGs Version 31.
We reviewed public comments
received and developed an update of
ICD–10 MS–DRGs Version 31, which we
called ICD–10 MS–DRGs Version 31.0–
R. We made available a Definitions
Manual of the ICD–10 MS–DRGs
Version 31.0–R on the ICD–10 MS–DRG
Conversion Project Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
ICD-10-MS-DRG-ConversionProject.html. We also prepared a
document that describes changes made
from Version 31 to Version 31–R to
facilitate a review. We will continue to
share ICD–10–MS–DRG conversion
activities with the public through this
Web site.
CMS prepared the ICD–10 MS–DRGs
Version 32 based on the FY 2015 MS–
DRGs (Version 32) that we finalized in
the FY 2015 IPPS/LTCH PPS final rule.
In November 2014, we made available a
Definitions Manual of the ICD–10 MS–
DRGs Version 32 on the ICD–10 MS–
DRG Conversion Project Web site at:
https://www.cms.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html. We also prepared a
document that described changes made
from Version 31–R to Version 32 to
facilitate a review. We produced
mainframe and computer software for
Version 32, which was made available
to the public in January 2015.
Information on ordering the mainframe
and computer software through NTIS
was made available on the CMS Web
site at: https://www.cms.gov/Medicare/
Coding/ICD10/ICD-10-MS-DRGConversion-Project.html under the
‘‘Related Links’’ section. This ICD–10
MS–DRGs Version 32 computer
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
software facilitated additional review of
the ICD–10 MS–DRGs conversion. We
encouraged the public to submit to CMS
any comments on areas where they
believed the ICD–10 MS–DRGs did not
accurately reflect grouping logic found
in the ICD–9–CM MS–DRGs Version 32.
We discuss five requests from the public
to update the ICD–10 MS–DRGs Version
32 to better replicate the ICD–9–CM
MS–DRGs in section II.G.3., 4., and 5. of
the preamble of this proposed rule.
Therefore, we are proposing to
implement the MS–DRG code logic in
the ICD–10 MS–DRGs Version 32 along
with any finalized updates to the ICD–
10 MS–DRGs Version 32 for the final
ICD–10 MS–DRGs Version 33. In this FY
2016 IPPS/LTCH PPS proposed rule, we
are proposing the ICD–10 MS–DRGs
Version 33 as the replacement logic for
the ICD–9–CM based MS–DRGs Version
32 as part of the proposed MS–DRG
updates for FY 2016. We are inviting
public comments on how well the ICD–
10 MS–DRGs Version 32 replicates the
logic of the MS–DRGs Version 32 based
on ICD–9–CM codes.
b. Basis for Proposed FY 2016 MS–DRG
Updates
CMS encourages input from our
stakeholders concerning the annual
IPPS updates when that input is made
available to us by December 7 of the
year prior to the next annual proposed
rule update. For example, to be
considered for any updates or changes
in FY 2016, comments and suggestions
should have been submitted by
December 7, 2014. The comments that
were submitted in a timely manner for
FY 2016 are discussed below in this
section.
Following are the changes we are
proposing to the MS–DRGs for FY 2016.
We are inviting public comment on each
of the MS–DRG classification proposed
changes described below, as well as our
proposals to maintain certain existing
MS–DRG classifications, which also are
discussed below. In some cases, we are
proposing changes to the MS–DRG
classifications based on our analysis of
claims data. In other cases, we are
proposing to maintain the existing MS–
DRG classification based on our analysis
of claims data. For this FY 2016
proposed rule, our MS–DRG analysis is
based on claims data from the December
2014 update of the FY 2014 MedPAR
file, which contains hospital bills
received through September 30, 2014,
for discharges occurring through
September 30, 2014. In our discussion
of the proposed MS–DRG
reclassification changes that follows, we
refer to our analysis of claims data from
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the ‘‘December 2014 update of the FY
2014 MedPAR file.’’
As explained in previous rulemaking
(76 FR 51487), in deciding whether to
propose to make further modification to
the MS–DRGs for particular
circumstances brought to our attention,
we consider whether the resource
consumption and clinical characteristics
of the patients with a given set of
conditions are significantly different
than the remaining patients in the MS–
DRG. We evaluate patient care costs
using average costs and lengths of stay
and rely on the judgment of our clinical
advisors to decide whether patients are
clinically distinct or similar to other
patients in the MS–DRG. In evaluating
resource costs, we consider both the
absolute and percentage differences in
average costs between the cases we
select for review and the remainder of
cases in the MS–DRG. We also consider
variation in costs within these groups;
that is, whether observed average
differences are consistent across
patients or attributable to cases that are
extreme in terms of costs or length of
stay, or both. Further, we consider the
number of patients who will have a
given set of characteristics and generally
prefer not to create a new MS–DRG
unless it would include a substantial
number of cases.
In our examination of the claims data,
we apply the following criteria
established in FY 2008 (72 FR 47169) to
determine if the creation of a new
complication or comorbidity (CC) or
major complication or comorbidity
(MCC) subgroup within a base MS–DRG
is warranted:
• A reduction in variance of costs of
at least 3 percent.
• At least 5 percent of the patients in
the MS–DRG fall within the CC or MCC
subgroup.
• At least 500 cases are in the CC or
MCC subgroup.
• There is at least a 20-percent
difference in average costs between
subgroups.
• There is a $2,000 difference in
average costs between subgroups.
In order to warrant creation of a CC
or MCC subgroup within a base MS–
DRG, the subgroup must meet all five of
the criteria.
2. MDC 1 (Diseases and Disorders of the
Nervous System): Endovascular
Embolization (Coiling) Procedures
We received a request again this year
to change the MS–DRG assignment for
endovascular embolization (coiling)
procedures. This topic was discussed
previously in the FY 2015 IPPS/LTCH
PPS proposed rule (79 FR 28005
through 28006) and in the FY 2015
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IPPS/LTCH PPS final rule (79 FR 49883
through 49886). For FY 2015, we did
not change the MS–DRG assignment for
endovascular embolization (coiling)
procedures.
After issuance of the FY 2015 IPPS/
LTCH PPS final rule, we received a
modified request from the commenter
asking that CMS consider establishing
four new MS–DRGs:
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures with Principal Diagnosis of
Hemorrhage);
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage with MCC);
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage with CC); and
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage without CC/MCC).
The requestor stated that these new
suggested MS–DRGs will promote
clinical cohesiveness and resource
comparability. The requestor stated that
endovascular intracranial and
endovascular embolization procedures
are not similar to the open craniotomy
procedures with which they are
currently grouped. The requestor
asserted that the differences in costs
between endovascular intracranial
procedures and open craniotomy
procedures are great, reflecting, for
instance, the use of an operating suite
versus interventional vascular
catheterization lab suite, intensive care
and other costs.
In conjunction with the recommended
new MS–DRGs, the requestor
recommended that the following ICD–9–
CM codes, which include endovascular
embolization procedures and additional
intracranial procedures, be removed
from MS–DRG 020 (Intracranial
Vascular Procedures with Principal
Diagnosis of Hemorrhage with MCC);
MS–DRG 021 (Intracranial Vascular
Procedures with Principal Diagnosis of
Hemorrhage with CC); MS–DRG 022
(Intracranial Vascular Procedures with
Principal Diagnosis of Hemorrhage
without CC/MCC); MS–DRG 023
(Craniotomy with Major Device
Implant/Acute Complex CNS Principal
Diagnosis with MCC or Chemo Implant);
MS–DRG 024 (Craniotomy with Major
Device Implant/Acute Complex CNS
Principal Diagnosis without MCC); MS–
DRG 025 (Craniotomy & Endovascular
Intracranial Procedures with MCC); MS–
DRG 026 (Craniotomy & Endovascular
Intracranial Procedures with CC); and
MS–DRG 027 (Craniotomy &
Endovascular Intracranial Procedures
without CC/MCC):
• 00.62 (Percutaneous angioplasty of
intracranial vessel);
• 39.72 (Endovascular (total)
embolization or occlusion of head and
neck vessels);
• 39.74 (Endovascular removal of
obstruction from head and neck
vessel(s));
• 39.75 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bare coils);
• 39.76 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bioactive coils); and
• 39.79 (Other endovascular
procedures on other vessels).
The requestor asked that the four new
requested MS–DRGs be created using
these procedure codes. The requestor
suggested that the first requested new
MS–DRG would be MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures with Principal Diagnosis of
Hemorrhage). The principal diagnoses
for hemorrhage would include the same
hemorrhage codes in the current MS–
DRGs 020, 021, and 022, which are as
follows:
• 094.87 (Syphilitic ruptured cerebral
aneurysm);
• 430 (Subarachnoid hemorrhage);
• 431 (Intracerebral hemorrhage);
• 432.0 (Nontraumatic extradural
hemorrhage);
• 432.1 (Subdural hemorrhage); and
• 432.9 (Unspecified intracranial
hemorrhage).
For this first new requested MS–DRG,
the requestor suggested that only the
following endovascular embolization
procedure codes would be assigned:
• 39.72 (Endovascular (total)
embolization or occlusion of head and
neck vessels);
• 39.75 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bare coils); and
• 39.76 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bioactive coils).
The requestor recommended that the
three additional new MS–DRGs would
consist of a new base MS–DRG
subdivided into three severity levels as
follows:
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage with MCC);
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage with CC); and
• Recommended MS–DRG XXX
(Endovascular Intracranial Embolization
Procedures without Principal Diagnosis
of Hemorrhage without CC/MCC).
The requestor suggested that these
three new recommended MS–DRGs
would have endovascular embolization
procedures as well as additional
percutaneous and endovascular
procedures as listed below:
• 00.62 (Percutaneous angioplasty of
intracranial vessel);
• 39.72 (Endovascular (total)
embolization or occlusion of head and
neck vessels);
• 39.74 (Endovascular removal of
obstruction from head and neck
vessel(s));
• 39.75 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bare coils);
• 39.76 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bioactive coils); and
• 39.79 (Other endovascular
procedures on other vessels).
ICD–10–PCS provides the following
more detailed codes for endovascular
embolization, which are assigned to
MS–DRGs 020, 021, 022, 023, 024, 025,
026, and 027 in the ICD–10 MS–DRGs
Version 32:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION ASSIGNED TO MS–DRGS 020 THROUGH 027 IN ICD–10 MS–
DRGS VERSION 32
ICD–10–PCS code
03LG3BZ ......................
03LG3DZ ......................
03LG4BZ ......................
03LG4DZ ......................
03LH3BZ .......................
03LH3DZ ......................
03LH4BZ .......................
03LH4DZ ......................
VerDate Sep<11>2014
Code description
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
18:20 Apr 29, 2015
of
of
of
of
of
of
of
of
intracranial artery with bioactive intraluminal device, percutaneous approach.
intracranial artery with intraluminal device, percutaneous approach.
intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach.
intracranial artery with intraluminal device, percutaneous endoscopic approach.
right common carotid artery with bioactive intraluminal device, percutaneous approach.
right common carotid artery with intraluminal device, percutaneous approach.
right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
right common carotid artery with intraluminal device, percutaneous endoscopic approach.
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24353
ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION ASSIGNED TO MS–DRGS 020 THROUGH 027 IN ICD–10 MS–
DRGS VERSION 32—Continued
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
03LJ3BZ .......................
03LJ3DZ .......................
03LJ4BZ .......................
03LJ4DZ .......................
03LK3BZ .......................
03LK3DZ .......................
03LK4BZ .......................
03LK4DZ .......................
03LL3BZ .......................
03LL3DZ .......................
03LL4BZ .......................
03LL4DZ .......................
03LM3BZ ......................
03LM3DZ ......................
03LM4BZ ......................
03LM4DZ ......................
03LN3BZ .......................
03LN3DZ ......................
03LN4BZ .......................
03LN4DZ ......................
03LP3BZ .......................
03LP3DZ .......................
03LP4BZ .......................
03LP4DZ .......................
03LQ3BZ ......................
03LQ3DZ ......................
03LQ4BZ ......................
03LQ4DZ ......................
03LR3DZ ......................
03LR4DZ ......................
03LS3DZ .......................
03LS4DZ .......................
03LT3DZ .......................
03LT4DZ .......................
03VG3BZ ......................
03VG3DZ ......................
03VG4BZ ......................
03VG4DZ ......................
03VH3BZ ......................
03VH3DZ ......................
03VH4BZ ......................
03VH4DZ ......................
03VJ3BZ .......................
03VJ3DZ .......................
03VJ4BZ .......................
03VJ4DZ .......................
03VK3BZ ......................
03VK3DZ ......................
03VK4BZ ......................
03VK4DZ ......................
03VL3BZ .......................
03VL3DZ .......................
03VL4BZ .......................
03VL4DZ .......................
03VM3BZ ......................
03VM3DZ ......................
03VM4BZ ......................
03VM4DZ ......................
03VN3BZ ......................
03VN3DZ ......................
03VN4BZ ......................
03VN4DZ ......................
03VP3BZ ......................
03VP3DZ ......................
03VP4BZ ......................
03VP4DZ ......................
03VQ3BZ ......................
03VQ3DZ ......................
03VQ4BZ ......................
03VQ4DZ ......................
03VR3DZ ......................
VerDate Sep<11>2014
Code description
Occlusion of left common carotid artery with bioactive intraluminal device, percutaneous approach.
Occlusion of left common carotid artery with intraluminal device, percutaneous approach.
Occlusion of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of left common carotid artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of right internal carotid artery with bioactive intraluminal device, percutaneous approach.
Occlusion of right internal carotid artery with intraluminal device, percutaneous approach.
Occlusion of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of right internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of left internal carotid artery with bioactive intraluminal device, percutaneous approach.
Occlusion of left internal carotid artery with intraluminal device, percutaneous approach.
Occlusion of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of left internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of right external carotid artery with bioactive intraluminal device, percutaneous approach.
Occlusion of right external carotid artery with intraluminal device, percutaneous approach.
Occlusion of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of right external carotid artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of left external carotid artery with bioactive intraluminal device, percutaneous approach.
Occlusion of left external carotid artery with intraluminal device, percutaneous approach.
Occlusion of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of left external carotid artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous approach.
Occlusion of right vertebral artery with intraluminal device, percutaneous approach.
Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of right vertebral artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous approach.
Occlusion of left vertebral artery with intraluminal device, percutaneous approach.
Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of left vertebral artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of face artery with intraluminal device, percutaneous approach.
Occlusion of face artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of right temporal artery with intraluminal device, percutaneous approach.
Occlusion of right temporal artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of left temporal artery with intraluminal device, percutaneous approach.
Occlusion of left temporal artery with intraluminal device, percutaneous endoscopic approach.
Restriction of intracranial artery with bioactive intraluminal device, percutaneous approach.
Restriction of intracranial artery with intraluminal device, percutaneous approach.
Restriction of intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of intracranial artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right common carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right common carotid artery with intraluminal device, percutaneous approach.
Restriction of right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right common carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left common carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left common carotid artery with intraluminal device, percutaneous approach.
Restriction of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left common carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right internal carotid artery with intraluminal device, percutaneous approach.
Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left internal carotid artery with intraluminal device, percutaneous approach.
Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right external carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right external carotid artery with intraluminal device, percutaneous approach.
Restriction of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right external carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left external carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left external carotid artery with intraluminal device, percutaneous approach.
Restriction of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left external carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right vertebral artery with bioactive intraluminal device, percutaneous approach.
Restriction of right vertebral artery with intraluminal device, percutaneous approach.
Restriction of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right vertebral artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left vertebral artery with bioactive intraluminal device, percutaneous approach.
Restriction of left vertebral artery with intraluminal device, percutaneous approach.
Restriction of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left vertebral artery with intraluminal device, percutaneous endoscopic approach.
Restriction of face artery with intraluminal device, percutaneous approach.
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ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION ASSIGNED TO MS–DRGS 020 THROUGH 027 IN ICD–10 MS–
DRGS VERSION 32—Continued
ICD–10–PCS code
03VR4DZ
03VS3DZ
03VS4DZ
03VT3DZ
03VT4DZ
03VU3DZ
03VU4DZ
03VV3DZ
03VV4DZ
......................
......................
......................
......................
......................
......................
......................
......................
......................
Code description
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
of
of
of
of
of
of
of
of
of
face artery with intraluminal device, percutaneous endoscopic approach.
right temporal artery with intraluminal device, percutaneous approach.
right temporal artery with intraluminal device, percutaneous endoscopic approach.
left temporal artery with intraluminal device, percutaneous approach.
left temporal artery with intraluminal device, percutaneous endoscopic approach.
right thyroid artery with intraluminal device, percutaneous approach.
right thyroid artery with intraluminal device, percutaneous endoscopic approach.
left thyroid artery with intraluminal device, percutaneous approach.
left thyroid artery with intraluminal device, percutaneous endoscopic approach.
For this FY 2016 IPPS/LTCH PPS
proposed rule request, we first
examined claims data on all intracranial
vascular procedure cases with a
principal diagnosis of hemorrhage
reported in MS–DRGs 020, 021, and 022
from the December 2014 update of the
FY 2014 MedPAR file. The table below
shows our findings. We found a total of
1,755 cases with an average length of
stay ranging from 8.28 days to 16.84
days and average costs ranging from
$36,998 to $71,665 in MS–DRGs 020,
021, and 022.
INTRACRANIAL VASCULAR PROCEDURES WITH PRINCIPAL DIAGNOSIS OF HEMORRHAGE
Number
of cases
MS–DRG
MS–DRG 020 (with MCC)—All cases .........................................................................................
MS–DRG 021 (with CC)—All cases ............................................................................................
MS–DRG 022 (without CC/MCC)—All cases ..............................................................................
Next, we examined claims data on the
first part of the request, which was to
create a new MS–DRG for endovascular
intracranial embolization procedure
cases with a principal diagnosis of
hemorrhage that are currently reported
in MS–DRGs 020, 021, and 022. Our
findings for the first part of this multi-
1,285
372
98
Average
length of stay
Average
costs
16.84
13.82
8.28
$71,655
52,143
36,998
part request are shown in the table
below.
ENDOVASCULAR INTRACRANIAL EMBOLIZATION PROCEDURES WITH PRINCIPAL DIAGNOSIS OF HEMORRHAGE
Number
of cases
Average
length of stay
Average
costs
Requested New Combined MS–DRG .........................................................................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
1,275
15.6
$67,831
The requestor suggested that this new
requested base MS–DRG would not be
subdivided by severity levels. Using the
requested code logic, cases with a
principal diagnosis of hemorrhage and
procedure codes 39.72 (Endovascular
(total) embolization or occlusion of head
and neck vessels), 39.75 (Endovascular
embolization or occlusion of vessel(s) of
head or neck using bare coils), and
39.76 (Endovascular embolization or
occlusion of vessel(s) of head or neck
using bioactive coils) would be moved
out of MS–DRGs 020, 021, and 022 and
into a single new MS–DRG with no
severity levels.
As can be seen in the table above, the
average costs for the new requested
combined MS–DRG would be $67,831.
The average costs for current MS–DRGs
020, 021, and 022 were $71,655,
$52,143, and $36,998, respectively.
Based on these findings, if we
established this requested new MS–
DRG, payments for those cases at the
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highest severity level (MS–DRG 020,
which had average costs of $71,655)
would be reduced. We believe that
maintaining the current MS–DRG
assignment for these types of procedures
is appropriate. Our clinical advisors
state that the current grouping of
procedures within MS–DRGs 020, 021,
and 022 reflects patients who are unique
in terms of utilization and complexity
based on the three severity levels, which
are specifically designed to capture
clinical differences in these patients,
and these factors support maintaining
the current structure. Therefore, we are
not proposing to move cases with a
principal diagnosis of hemorrhage and
procedure codes 39.72, 39.75, and 39.76
out of MS–DRGs 020, 021, and 022 and
create a new base MS–DRG. We are
inviting public comments on this
proposal.
As discussed previously, the
requestor also recommended the
creation of a new set of MS–DRGs for
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Fmt 4701
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endovascular intracranial embolization
procedures without a principal
diagnosis of hemorrhage with MCC,
with CC, and without CC/MCC. For
these new requested MS–DRGs, the
requestor suggested assignment of
endovascular embolization procedures
as well as certain other percutaneous
and endovascular procedures. The
complete list of endovascular
intracranial embolization procedures
developed by the requestor is as follows:
• 00.62 (Percutaneous angioplasty of
intracranial vessel);
• 39.72 (Endovascular (total)
embolization or occlusion of head and
neck vessels);
• 39.74 (Endovascular removal of
obstruction from head and neck
vessel(s));
• 39.75 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bare coils);
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• 39.76 (Endovascular embolization
or occlusion of vessel(s) of head or neck
using bioactive coils); and
• 39.79 (Other endovascular
procedures on other vessels)
The following table shows our
findings from examination of claims
data on endovascular intracranial
procedures without a principal
diagnosis of hemorrhage reported in
MS–DRGs 023 through 027 from the
December 2014 update of the FY 2014
MedPAR file.
ENDOVASCULAR INTRACRANIAL PROCEDURES WITHOUT PRINCIPAL DIAGNOSIS OF HEMORRHAGE
Number
of cases
MS–DRG
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 023—All cases ............................................................................................................
MS–DRG 023—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................
MS–DRG 024—All cases ............................................................................................................
MS–DRG 024—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................
MS–DRG 025—All cases ............................................................................................................
MS–DRG 025—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................
MS–DRG 026—All cases ............................................................................................................
MS–DRG 026—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................
MS–DRG 027—All cases ............................................................................................................
MS–DRG 027—Cases with endovascular intracranial procedure without diagnosis of hemorrhage ........................................................................................................................................
As can be seen from this table, if we
created a new set of MS–DRGs
recommended by the requester, most of
the cases would have to be moved out
of MS–DRGs 023 and 027. The 1,510
cases that would have to be moved out
of MS–DRG 023 have average costs of
$39,666 compared to average costs of
$37,784 for all cases in MS–DRG 023.
The average costs for these cases are not
significantly different from the average
costs for all cases in MS–DRG 023. The
average length of stay for the cases with
endovascular intracranial procedure
without a diagnosis of hemorrhage in
MS–DRG 023 is 8.88 compared to 10.96
days for all cases in MS–DRG 023. We
believe that these data support the
current MS–DRG assignment for MS–
DRG 023. The 1,793 cases that would
have to be moved out of MS–DRG 027
have average costs of $22,244 compared
to the average costs of $16,613 for all
cases in MS–DRG 027. While the
average costs for these cases are higher
than for all cases in MS–DRG 027, one
would expect some procedures within
an MS–DRG to have higher average
costs and other procedures to have
lower average costs than the overall
average costs. Cases within the MS–
DRGs describing endovascular
intracranial procedures are grouped
together based on similar clinical and
resource criteria. Some cases will have
average costs that are higher than the
overall average costs for cases in the
MS–DRG, while other cases will have
lower average costs. These differences
in average costs are found within all
MS–DRGs. The average length of stay of
MS–DRG 027 cases with endovascular
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intracranial procedure without a
diagnosis of hemorrhage is 1.66 days as
compared to 3.15 days for all cases in
MS–DRG 027. Therefore, while the
average costs are higher for the cases
with endovascular intracranial
procedure without a diagnosis of
hemorrhage than for all cases in MS–
DRG 027, the length of stay is shorter.
The 867 cases that would have to be
moved out of MS–DRG 024 have average
costs of $27,975 compared to average
costs for all cases in MS–DRG 024 of
$26,195. The average costs for these
cases are not significantly different than
the average costs for all cases in MS–
DRG 024. The average length of stay for
the 867 cases that would have to be
moved out of MS–DRG 024 is 5.80
compared to 5.93 for all cases in MS–
DRG 024. Therefore, the lengths of stay
for the cases also are quite similar in
MS–DRG 024. We have determined that
these data findings support maintaining
the current MS–DRG assignment of
these procedures in MS–DRG 024.
MS–DRGs 025 and 026 show the
smallest number of cases that would
have to be moved to the requested new
MS–DRGs, but these cases have larger
differences in average costs. The average
costs of cases that would have to be
moved out of MS–DRG 025 are $44,082
compared to $29,970 for all cases in
MS–DRG 025. The average length of stay
for the MS–DRG 025 cases with
endovascular intracranial procedure
without a diagnosis of hemorrhage is
8.52 days as compared to 9.35 days for
all cases in MS–DRG 025. Therefore, the
lengths of stay are similar for cases in
MS–DRG 025. The average costs of cases
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Average
length of stay
Average
costs
5,615
10.96
$37,784
1,510
1,848
8.88
5.93
39,666
26,195
867
16,949
5.80
9.35
27,975
29,970
650
8,075
8.52
6.09
44,082
21,414
778
9,883
3.07
3.15
26,594
16,613
1,793
1.66
22,244
that would have to be moved out of MS–
DRG 026 are $26,594 compared to
$21,414 for all cases. The average length
of stay for cases that would have to be
moved out of MS–DRG 026 is 3.07 days
compared to 6.09 days for all cases in
MS–DRG 026, or almost half as long as
for all cases in MS–DRG 026. As stated
earlier, the average costs for cases that
would be moved out of MS–DRGs 023,
024, 025, 026, and 027 under this
request are higher than the average costs
for all cases in these MS–DRGs, with
most of the cases coming out of MS–
DRGs 023 and 027. The average costs for
these particular cases in MS–DRG 023
are not significantly different from the
average costs for all cases in MS–DRG
023. In addition, while the average costs
are higher for the cases with a
endovascular intracranial procedure
without a diagnosis of hemorrhage than
for all cases in MS–DRG 027, the length
of stay is shorter. We have determined
that the overall data do not support
making the requested MS–DRG updates
to MS–DRGs 023, 024, 025, 026, and 027
and creating three new MS–DRGs.
Therefore, we are not proposing to make
changes to the current structure for MS–
DRGs 023 through 027.
In summary, our clinical advisors
reviewed each aspect of this multi-part
request and advised us that the
endovascular embolization procedures
are appropriately assigned to MS–DRGs
020 through 027. They do not support
removing the procedures (procedure
codes 39.72, 39.75, and 39.76) from MS–
DRGs 020, 021, and 022 and creating a
single MS–DRG for endovascular
intracranial embolization procedures
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with a principal diagnosis of
hemorrhage with no severity levels. Our
clinical advisors stated that the current
MS–DRG grouping of three severity
levels captures differences in clinical
severity, average costs, and length of
stay for these patients appropriately.
Our clinical advisors also recommended
maintaining the current MS–DRG
assignments for endovascular
embolization and other percutaneous
and endovascular procedures within
MS–DRGs 023 through 027. They stated
that these procedures are all clinically
similar to others in these MS–DRGs. In
addition, they stated that the surgical
techniques are all designed to correct
the same clinical problem, and they
advised against moving a select number
of those procedures out of MS–DRGs
023 through 027.
Based on the findings from our data
analysis and the recommendations from
our clinical advisors, we are not
proposing to create the four new MS–
DRGs for endovascular intracranial
embolization and other endovascular
procedures recommended by the
requestor. We are proposing to maintain
the current MS–DRG structure for MS–
DRGs 020 through 027.
We are inviting public comments on
these two proposals.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
3. MDC 5 (Diseases and Disorders of the
Circulatory System)
a. Adding Severity Levels to MS–DRGs
245 Through 251
During the comment period for the FY
2015 IPPS/LTCH PPS proposed rule, we
received a comment that recommended
establishing severity levels for MS–DRG
245 (AICD Generator Procedures) and
including additional severity levels for
MS–DRG 246 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent with MCC or 4+ Vessels/
Stents); MS–DRG 247 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent without MCC); MS–DRG
248 (Percutaneous Cardiovascular
Procedure with Non-Drug-Eluting Stent
with MCC or 4+ Vessels/Stents); MS–
DRG 249 (Percutaneous Cardiovascular
Procedure with Non-Drug-Eluting Stent
without MCC); MS–DRG 250
(Percutaneous Cardiovascular Procedure
without Coronary Artery Stent with
MCC); and MS–DRG 251 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent without MCC).
We considered this public comment
to be outside of the scope of the FY 2015
IPPS/LTCH PPS proposed rule.
Therefore, we did not address this
comment in the FY 2015 IPPS/LTCH
PPS final rule. However, we indicated
that we would consider the public
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comment for possible proposals in
future rulemaking as part of our annual
review process.
For this FY 2016 IPPS/LTCH PPS
proposed rule, we received a separate,
but related, request involving most of
these same MS–DRGs. Therefore, for
this proposed rule, we conducted a
simultaneous analysis of claims data to
address both the FY 2015 public
comment request and the related FY
2016 request. We discuss both of these
requests below.
b. Percutaneous Intracardiac Procedures
We received a request to remove the
cardiac ablation and other specified
cardiovascular procedures from the
following MS–DRGs, and to create new
MS–DRGs to classify these procedures:
• MS–DRG 246 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent with MCC or 4+ Vessels/
Stents);
• MS–DRG 247 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent without MCC);
• MS–DRG 248 (Percutaneous
Cardiovascular Procedure with NonDrug-Eluting Stent with MCC or 4+
Vessels/Stents);
• MS–DRG 249 (Percutaneous
Cardiovascular Procedure with NonDrug-Eluting Stent without MCC);
• MS–DRG 250 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent with MCC); and
• MS–DRG 251 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent without MCC).
The commenter stated that,
historically, the MS–DRGs listed above
appropriately reflected the differential
cost of percutaneous transluminal
coronary angioplasty (PTCA) procedures
with and without stents. The
commenter noted that PTCA procedures
with drug eluting stents were previously
paid the highest, followed by PTCA
procedures with bare metal stents and
PTCA procedures with no stents,
respectively. However, the commenter
believed that, in recent years, the
opposite has begun to occur and cases
reporting a PTCA procedure without a
stent are being paid more than cases
reporting a PTCA procedure with a
stent. The commenter further noted that
cardiac ablation procedures and PTCA
procedures without stents are currently
assigned to the same MS–DRGs,
notwithstanding that the procedures
have different clinical objectives and
patient diagnoses. The commenter
indicated that cardiac ablation
procedures are performed on patients
with multiple distinct cardiac
arrhythmias to alter electrical
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Fmt 4701
Sfmt 4702
conduction systems of the heart, and
PTCA procedures are performed on
patients with coronary atherosclerosis to
open blocked coronary arteries. The
commenter also noted that cardiac
ablation procedures are performed in
the heart chambers by cardiac
electrophysiologists, require
significantly more resources, and
require longer periods of time to
complete. Conversely, PTCA procedures
are performed in the coronary vessels by
interventional cardiologists, require the
use of less equipment, and require a
shorter period of time to complete.
Therefore, the commenter suggested that
CMS create new MS–DRGs for
percutaneous intracardiac procedures to
help improve clinical homogeneity by
differentiating percutaneous
intracardiac procedures (performed
within the heart chambers) from
percutaneous intracoronary procedures
(performed within the coronary vessels).
The commenter further believed that
creating new MS–DRGs for these
procedures would also better reflect the
resource cost of specialized equipment
used for more complex structures of
electrical conduction systems when
performing cardiac ablation procedures.
The following ICD–9–CM procedure
codes identify and describe the cardiac
ablation procedures and the other
percutaneous intracardiac procedures
that are currently classified under MS–
DRGs 246 through 251 and that the
commenter recommended that CMS
assign to the newly created MS–DRGs:
• 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);
• 37.36 (Excision, destruction, or
exclusion of left atrial appendage
(LAA)); and
• 37.90 (Insertion of left atrial
appendage device).
There are a number of ICD–10–PCS
code translations that provide more
detailed and specific information for
each of the ICD–9–CM procedure codes
listed above that also are currently
classified under MS–DRGs 246 through
251 based on the GROUPER Version 32
ICD–10 MS–DRGs. The comparable
ICD–10–PCS code translations for ICD–
9–CM procedure code 35.52 are shown
in the following table.
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24357
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.52
ICD–10–PCS code
02U53JZ .......................
02U54JZ .......................
Code description
Supplement atrial septum with synthetic substitute, percutaneous approach.
Supplement atrial septum with synthetic substitute, percutaneous endoscopic approach.
The comparable ICD–10–PCS code
translations for ICD–9–CM procedure
code 35.96 are shown in the following
table.
ICD–10–PCS TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.96
ICD–10–PCS code
027F34Z .......................
027F3DZ .......................
027F3ZZ .......................
027F44Z .......................
027F4DZ .......................
027F4ZZ .......................
027G34Z .......................
027G3DZ ......................
027G3ZZ .......................
027G44Z .......................
027G4DZ ......................
027G4ZZ .......................
027H34Z .......................
027H3DZ ......................
027H3ZZ .......................
027H44Z .......................
027H4DZ ......................
027H4ZZ .......................
027J34Z ........................
027J3DZ .......................
027J3ZZ ........................
027J44Z ........................
027J4DZ .......................
027J4ZZ ........................
Code description
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
Dilation
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
aortic valve with drug-eluting intraluminal device, percutaneous approach.
aortic valve with intraluminal device, percutaneous approach.
aortic valve, percutaneous approach.
aortic valve with drug-eluting intraluminal device, percutaneous endoscopic approach.
aortic valve with intraluminal device, percutaneous endoscopic approach.
aortic valve, percutaneous endoscopic approach.
mitral valve with drug-eluting intraluminal device, percutaneous approach.
mitral valve with intraluminal device, percutaneous approach.
mitral valve, percutaneous approach.
mitral valve with drug-eluting intraluminal device, percutaneous endoscopic approach.
mitral valve with intraluminal device, percutaneous endoscopic approach.
mitral valve, percutaneous endoscopic approach.
pulmonary valve with drug-eluting intraluminal device, percutaneous approach.
pulmonary valve with intraluminal device, percutaneous approach.
pulmonary valve, percutaneous approach.
pulmonary valve with drug-eluting intraluminal device, percutaneous endoscopic approach.
pulmonary valve with intraluminal device, percutaneous endoscopic approach.
pulmonary valve, percutaneous endoscopic approach.
tricuspid valve with drug-eluting intraluminal device, percutaneous approach.
tricuspid valve with intraluminal device, percutaneous approach.
tricuspid valve, percutaneous approach.
tricuspid valve with drug-eluting intraluminal device, percutaneous endoscopic approach.
tricuspid valve with intraluminal device, percutaneous endoscopic approach.
tricuspid valve, percutaneous endoscopic approach.
The ICD–10–PCS code translation for
ICD–9–CM procedure code 35.97 is
02UG3JZ (Supplement mitral valve with
synthetic substitute, percutaneous
approach.).
The ICD–10–PCS code translation for
ICD–9–CM procedure code 37.26 is
4A023FZ (Measurement of cardiac
rhythm, percutaneous approach.).
The comparable ICD–10–PCS code
translations for ICD–9–CM procedure
code 37.27 are shown in the following
table.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.27
ICD–10–PCS code
02K83ZZ .......................
02K84ZZ .......................
Code description
Map conduction mechanism, percutaneous approach.
Map conduction mechanism, percutaneous endoscopic approach.
The comparable ICD–10–PCS code
translations for ICD–9–CM procedure
code 37.34 are shown in the following
table:
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.34
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
02553ZZ .......................
02563ZZ .......................
02573ZZ .......................
02583ZZ .......................
02593ZZ .......................
025F3ZZ .......................
025G3ZZ .......................
025H3ZZ .......................
025J3ZZ ........................
025K3ZZ .......................
025L3ZZ .......................
VerDate Sep<11>2014
Code description
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
Destruction
18:20 Apr 29, 2015
of
of
of
of
of
of
of
of
of
of
of
atrial septum, percutaneous approach.
right atrium, percutaneous approach.
left atrium, percutaneous approach.
conduction mechanism, percutaneous approach.
chordae tendineae, percutaneous approach.
aortic valve, percutaneous approach.
mitral valve, percutaneous approach.
pulmonary valve, percutaneous approach.
tricuspid valve, percutaneous approach.
right ventricle, percutaneous approach.
left ventricle, percutaneous approach.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.34—Continued
ICD–10–PCS code
025M3ZZ ......................
02B53ZZ .......................
02B63ZZ .......................
02B73ZZ .......................
02B83ZZ .......................
02B93ZZ .......................
02BF3ZZ .......................
02BG3ZZ ......................
02BH3ZZ ......................
02BJ3ZZ .......................
02BM3ZZ ......................
02T83ZZ .......................
Code description
Destruction of ventricular septum, percutaneous approach.
Excision of atrial septum, percutaneous approach.
Excision of right atrium, percutaneous approach.
Excision of left atrium, percutaneous approach.
Excision of conduction mechanism, percutaneous approach.
Excision of chordae tendineae, percutaneous approach.
Excision of aortic valve, percutaneous approach.
Excision of mitral valve, percutaneous approach.
Excision of pulmonary valve, percutaneous approach.
Excision of tricuspid valve, percutaneous approach.
Excision of ventricular septum, percutaneous approach.
Resection of conduction mechanism, percutaneous approach.
The comparable ICD–10–PCS code
translations for ICD–9–CM procedure
code 37.36 are shown in the following
table:
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.36
ICD–10–PCS code
02573ZK
02574ZK
02B73ZK
02B74ZK
02L73ZK
02L74ZK
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Destruction of left atrial appendage, percutaneous approach.
Destruction of left atrial appendage, percutaneous endoscopic approach.
Excision of left atrial appendage, percutaneous approach.
Excision of left atrial appendage, percutaneous endoscopic approach.
Occlusion of left atrial appendage, percutaneous approach.
Occlusion of left atrial appendage, percutaneous endoscopic approach.
The comparable ICD–10–PCS code
translations for ICD–9–CM procedure
code 37.90 are shown in the following
table:
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.90
ICD–10–PCS code
02L73CK
02L73DK
02L74CK
02L74DK
.......................
.......................
.......................
.......................
Code description
Occlusion
Occlusion
Occlusion
Occlusion
of
of
of
of
left
left
left
left
atrial
atrial
atrial
atrial
The ICD–10–PCS code translations
listed above, along with their respective
MS–DRG assignments, can be found in
the ICD–10 MS–DRGs Version 32
Definitions Manual posted on the CMS
Web site at: https://www.cms.gov/
appendage
appendage
appendage
appendage
with
with
with
with
extraluminal device, percutaneous approach.
intraluminal device, percutaneous approach.
extraluminal device, percutaneous endoscopic approach.
intraluminal device, percutaneous endoscopic approach.
Medicare/Coding/ICD10/ICD-10-MSDRG-Conversion-Project.html.
As mentioned earlier, we received a
separate, but related, request to add
severity levels to MS–DRGs 246 through
251. We address this request at the end
of this section.
To address the first of these separate,
but related, requests, we reviewed
claims data for MS–DRGs 246 through
251 from the December 2014 update of
the FY 2014 MedPAR file. Our findings
are shown in the following table:
PERCUTANEOUS CARDIOVASCULAR MS–DRGS WITH AND WITHOUT STENTS
Number
of cases
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
MS–DRG 246—All cases ............................................................................................................
MS–DRG 246—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
MS–DRG 247—All cases ............................................................................................................
MS–DRG 247—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
MS–DRG 248—All cases ............................................................................................................
MS–DRG 248 –Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
MS–DRG 249—All cases ............................................................................................................
MS–DRG 249—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
MS–DRG 250—All cases ............................................................................................................
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Average
length of
stay
Average
costs
30,617
5.52
$23,855
244
79,639
9.69
2.69
$34.099
$15,671
260
9,310
5.20
6.37
$25,797
$22,504
125
16,273
10.76
3.08
$33,521
$14,066
81
9,275
5.12
7.07
$23,710
$22,902
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PERCUTANEOUS CARDIOVASCULAR MS–DRGS WITH AND WITHOUT STENTS—Continued
Number
of cases
MS–DRG
MS–DRG 250– Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
MS–DRG 251—All cases ............................................................................................................
MS–DRG 251—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90 .................................................................................................................................
As shown in the table above, there
were a total of 30,617 cases in MS–DRG
246, with an average length of stay of
5.52 days and average costs of $23,855.
For cases reporting a percutaneous
intracardiac procedure in MS–DRG 246
(ICD–9–CM procedure codes 35.52,
35.96, 35.97, 37.26, 37.27, 37.34, 37.36,
and 37.90), there were a total of 244
cases, with an average length of stay of
9.69 days and average costs of $34,099.
For MS–DRGs 247 through 251, a
similar pattern was identified; the data
reflected that the average costs are
higher and the average length of stay is
greater for cases reporting a
percutaneous intracardiac procedure in
comparison to the average costs and
average length of stay for all of the cases
in their respective MS–DRGs.
Average
length of
stay
Average
costs
5,826
20,945
7.90
3.25
$24,841
$15,757
14,436
3.39
$17,290
As reflected in the following table, a
further analysis of the data showed that
percutaneous intracardiac procedures
represent a total of 20,972 cases in MS–
DRGs 246 through 251, with a greater
average length of stay (4.79 days versus
3.62 days) and higher average costs
($19,810 versus $17,532) in comparison
to all of the remaining cases in MS–
DRGs 246 through 251.
SUMMARY OF PERCUTANEOUS CARDIOVASCULAR DRGS WITH AND WITHOUT STENTS
Number
of cases
MS–DRG
MS–DRGs 246 through 251—Cases with procedure codes 35.52, 35.96, 35.97, 37.26, 37.27,
37.34, 37.36, and 37.90 ...........................................................................................................
MS–DRGs 246 through 251—Cases without procedure codes 35.52, 35.96, 35.97, 37.26,
37.27, 37.34, 37.36, and 37.90 ................................................................................................
The results of these data analyses
support removing procedures performed
within the heart chambers using
intracardiac techniques from MS–DRGs
246 through 251, and assigning these
procedures to separate MS–DRGs. The
results of these data analyses also
support subdividing these MS–DRGs
using the ‘‘with MCC’’ and ‘‘without
MCC’’ severity levels based on the
application of the criteria established in
the FY 2008 IPPS final rule (72 FR
47169), and described in section
II.G.1.b. of the preamble of this
proposed rule, that must be met to
warrant the creation of a CC or an MCC
subgroup within a base MS–DRG. Our
clinical advisors also agree that this
differentiation would improve the
clinical homogeneity of these MS–DRGs
by separating percutaneous intracardiac
procedures (performed within the heart
chambers) from percutaneous
intracoronary procedures (performed
within the coronary vessels). In
addition, we believe that creating these
new MS–DRGs would better reflect the
resource cost of specialized equipment
used to perform more complex
structures of electrical conduction
systems during cardiac ablation
procedures. Therefore, for FY 2016, we
are proposing to create two new MS–
DRGs to classify percutaneous
intracardiac procedures. Specifically,
we are proposing to create MS–DRG
273, entitled ‘‘Percutaneous Intracardiac
Procedures with MCC,’’ and MS–DRG
Average
length of
stay
Average
costs
20,972
4.79
$19,810
145,087
3.62
17,532
274, entitled ‘‘Percutaneous Intracardiac
Procedures without MCC,’’ and to assign
the procedures performed within the
heart chambers using intracardiac
techniques to the two proposed new
MS–DRGs. We are proposing that
existing percutaneous intracoronary
procedures with and without stents
continue to be assigned to the other
MS–DRGs to reflect that those
procedures are performed within the
coronary vessels and require fewer
resources.
The table below represents the
distribution of cases, average length of
stay, and average costs for these
proposed two new MS–DRGs.
PROPOSED NEW MS–DRGS FOR PERCUTANEOUS INTRACARDIAC PROCEDURES
Number
of cases
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
Proposed MS–DRG 273 with MCC .............................................................................................
Proposed MS–DRG 274 without MCC ........................................................................................
We are inviting public comments on
our proposal to create the two new MS–
DRGs for percutaneous intracardiac
procedures for FY 2016. In addition, we
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are inviting public comments on the
ICD–10–PCS code translations that were
presented earlier in this section and our
proposal to assign these procedure
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6,195
14,777
Average
length of
stay
8.03
3.44
Average
costs
$25,380
17,475
codes to the proposed new MS–DRGs
273 and 274.
As mentioned earlier in this section,
we received a similar request in
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response to the FY 2015 IPPS/LTCH
PPS proposed rule to add severity levels
to MS–DRGs 246 through 251. We
considered this public comment to be
outside of the scope of the FY 2015
IPPS/LTCH PPS proposed rule.
Therefore, we did not address this
comment in the FY 2015 IPPS/LTCH
PPS final rule. However, we indicated
that we would consider the public
comment for possible proposals in
future rulemaking as part of our annual
review process. Specifically, the
commenter recommended including
additional severity levels for MS–DRGs
246 through 251 and establishing
severity levels for MS–DRG 245 (AICD
Generator Procedures).
For our data analysis for this
recommendation, we examined claims
data from the December 2014 update of
the FY 2014 MedPAR file to determine
if including additional severity levels in
MS–DRGs 246 through 251 was
Percutaneous cardiovascular MS–DRG with and without stent procedures
by suggested severity level
Suggested
Suggested
Suggested
Suggested
Suggested
Suggested
Suggested
Suggested
Suggested
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
246
246
246
248
248
248
250
250
250
warranted. During our analysis, we
applied the criteria established in the
FY 2008 IPPS final rule (72 FR 47169),
as described in section II.G.1.b. of the
preamble of this proposed rule. As
shown in the table below, we collapsed
MS–DRGs 246 through 251 into base
MS–DRGs (MS–DRGs 246, 248, and 250)
by suggested severity level and applied
the criteria.
Number
of cases
with MCC ...........................................................................................
with CC ..............................................................................................
without CC/MCC ................................................................................
with MCC ...........................................................................................
with CC ..............................................................................................
without CC/MCC ................................................................................
with MCC ...........................................................................................
with CC ..............................................................................................
without CC/MCC ................................................................................
We found that the criterion that there
be a $2,000 difference in average costs
between subgroups was not met.
Specifically, between the ‘‘with CC’’ and
‘‘without CC/MCC’’ subgroups for base
MS–DRG 246, the difference in average
costs was only $1,305; for base MS–DRG
248, the difference in average costs was
only $1,761; and for base MS–DRG 250,
the difference in average costs was only
$803. The results of the data analysis of
MS–DRGs 246 through 251 confirmed,
Average
length of
stay
30,617
45,313
34,326
9,310
9,510
6,763
9,275
11,653
9,292
5.52
2.96
2.33
6.37
3.49
2.51
7.07
3.80
2.56
Average
costs
$23,855
16,233
14,928
22,504
14,798
13,037
22,903
16,113
15,310
and our clinical advisors agreed, that
the existing 2-way severity level splits
for these MS–DRGs (with MCC and
without MCC) are appropriate, as
displayed in the table below.
PERCUTANEOUS CARDIOVASCULAR MS–DRGS WITH AND WITHOUT STENTS
Number of
cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
246—All
247—All
248—All
249—All
250—All
251—All
cases
cases
cases
cases
cases
cases
............................................................................................................
............................................................................................................
............................................................................................................
............................................................................................................
............................................................................................................
............................................................................................................
Therefore, we are not proposing to
further subdivide the severity levels for
MS–DRGs 246 through 251. We are
inviting public comments on our
proposal not to create additional
severity levels for MS–DRGs 246
through 251.
Using the same MedPAR claims data
for FY 2014, we separately examined
cases in MS–DRG 245 to determine
whether to subdivide this MS–DRG into
Average
length of stay
30,617
79,639
9,310
16,273
9,275
20,945
5.52
2.69
6.37
3.08
7.07
3.25
Average
costs
$23,855
15,671
22,504
14,066
22,903
15,757
severity levels. As displayed in the table
below, the results of the FY 2014 data
analysis showed there were a total of
1,699 cases, with an average length of
stay of 5.49 days and average costs of
$34,287, in MS–DRG 245.
AICD GENERATOR PROCEDURES
Number of
cases
Average
length of stay
Average
costs
MS–DRG 245—All cases ............................................................................................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
1,699
5.49
$34,287
We applied the five criteria
established in the FY 2008 IPPS final
rule (72 FR 47169), as described in
section II.G.1.b. of the preamble of this
proposed rule, to determine if it was
appropriate to subdivide MS–DRG 245
into severity levels. The table below
illustrates our findings.
Number of
cases
AICD generator procedures by suggested severity level
Suggested MS–DRG 245 with MCC ...........................................................................................
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Average
length of stay
8.15
Average
costs
$40,004
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Number of
cases
AICD generator procedures by suggested severity level
Suggested MS–DRG 245 with CC ..............................................................................................
Suggested MS–DRG 245 without CC/MCC ................................................................................
Based on the analysis of the FY 2014
claims data for MS–DRG 245, the results
support creating a ‘‘with MCC’’ and a
‘‘without MCC’’ severity level split. Our
clinical advisors indicated that it would
not be clinically appropriate to add
severity levels based on an isolated
year’s data fluctuation because this
could lead to a lack of stability in MS–
DRG payments. We agree with our
clinical advisors and note that we
annually conduct an analysis of base
MS–DRGs to evaluate if additional
severity levels are warranted. This
analysis includes 2 years of MedPAR
claims data to specifically compare data
results from 1 year to the next to avoid
making determinations about whether
additional severity levels are warranted
based on an isolated year’s data
fluctuation. Generally, in past years, for
our review of requests to add or
establish severity levels, in our analysis
of the most recent claims data, there was
at least one criterion that was not met.
Therefore, it was not necessary to
further analyze data beyond 1 year.
However, the results of our analysis of
Average
length of stay
939
218
4.51
3.12
Average
costs
32,237
28,907
claims data in the December 2014
update of the FY 2014 MedPAR file for
this particular request involving MS–
DRG 245 demonstrate that all five
criteria to establish subgroups were met,
and, therefore, it was necessary to also
examine the FY 2013 MedPAR claims
data file.
The results of our analysis from the
December 2013 update of the FY 2013
claims data for MS–DRG 245 are shown
in the table below.
AICD GENERATOR PROCEDURES
MS–DRG
Number of
cases
Average
length of stay
Average
costs
MS–DRG 245—All cases ............................................................................................................
1,850
4.81
$33,272
The FY 2013 claims data for MS–DRG
245 do not support creating any severity
levels because the data did not meet one
or more of the five required criteria for
creating new severity levels. The data
did not meet the requirement for a 3way severity level split (with MCC, with
CC, and without CC/MCC) or a 2-way
severity level split (with MCC and
without MCC) because there were not at
least 500 cases in the MCC subgroup.
While the data did meet this particular
criterion for the 2-way severity level
split of ‘‘with CC/MCC’’ and ‘‘without
CC/MCC’’ because there were at least
500 cases in the CC subgroup, the data
did not meet the criterion that there be
at least a 20-percent difference in
average costs between subgroups, as
shown in the table below.
AICD GENERATOR PROCEDURES
Number of
cases
MS–DRG by suggested severity level
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 245 with MCC .............................................................................................................
MS–DRG 245 with CC ................................................................................................................
MS–DRG 245 without CC/MCC ..................................................................................................
As stated previously, we believe that
2 years of data showing that the
requested CC or MCC subgroup meets
all five of the established criteria for
creating severity levels are needed in
order to support a proposal to add
severity levels for MS–DRG 245. Our
clinical advisors also agree that it would
not be clinically appropriate to add
severity levels based on an isolated
year’s data fluctuation because this
could lead to a lack of stability in
payments. Therefore, we are not
proposing to add severity levels for MS–
DRG 245 for FY 2016. We are inviting
public comments on the results of our
analysis and our proposal not to create
severity levels for MS–DRG 245.
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c. Zilver® PTX Drug-Eluting Peripheral
Stent (Zilver® PTX®)
Zilver® PTX Drug-Eluting Peripheral
Stent (Zilver® PTX®) was approved for
new technology add-on payments in FY
2014 (78 FR 50583 through 50585).
Cases involving the Zilver® PTX® that
are eligible for new technology add-on
payments are identified by ICD–9–CM
procedure code 00.60 (Insertion of drugeluting stent(s) of superficial femoral
artery).
We received a request from the
manufacturer for an extension of new
technology add-on payments for Zilver®
PTX® in FY 2016. In the request, the
manufacturer asked CMS to consider
three options for procedure code 00.60
for FY 2016. The first option was to
extend the new technology add-on
payment through FY 2016. The request
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44
1,118
288
Average
length of stay
7.32
4.26
3.10
Average
costs
$39,536
31,786
29,383
to extend the new technology add-on
payment is addressed in section II.I.3.e.
of the preamble of this proposed rule.
The second option was to establish a
new family of MS–DRGs for drugeluting stents used in the peripheral
(noncoronary) vasculature. The third
option was to assign all Zilver® PTX®
cases to MS–DRG 252 even if there is no
MCC (which would necessitate revising
the MS–DRG title to ‘‘Other Vascular
Procedures).
ICD–10–PCS provides the following
more detailed procedure codes for the
insertion of drug-eluting stents of
superficial femoral artery:
• 047K04Z (Dilation of right femoral
artery with drug-eluting intraluminal
device, open approach);
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• 047K34Z (Dilation of right femoral
artery with drug-eluting intraluminal
device, percutaneous approach);
• 047K44Z (Dilation of right femoral
artery with drug-eluting intraluminal
device, percutaneous endoscopic
approach);
• 047L04Z (Dilation of left femoral
artery with drug-eluting intraluminal
device, open approach);
• 047L34Z (Dilation of left femoral
artery with drug-eluting intraluminal
device, percutaneous approach); and
• 047L44Z (Dilation of left femoral
artery with drug-eluting intraluminal
device, percutaneous endoscopic
approach).
We examined claims data for the
drug-eluting peripheral stent procedures
cases reported in the December 2014
update of the FY 2014 MedPAR file for
MS–DRGs 252, 253, and 254 (Other
Vascular Procedures with MCC, with CC
and without CC/MCC, respectively). The
following table illustrates our findings.
DRUG-ELUTING PERIPHERAL STENT PROCEDURES
Number of
cases
MS–DRGs
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
252—All cases ............................................................................................................
252—Cases with procedure code 00.60 ....................................................................
253—All cases ............................................................................................................
253—Cases with procedure code 00.60 ....................................................................
254—All cases ............................................................................................................
254—Cases with procedure code 00.60 ....................................................................
Our findings show that there were
only 601 peripheral angioplasty cases
with a drug-eluting stent reported. Of
the 601 peripheral angioplasty cases
with a drug-eluting stent, 133 cases
were in MS–DRG 252, 353 cases were in
MS–DRG 253, and 115 cases were in
MS–DRG 254. The average costs for the
drug-eluting stent cases in MS–DRGs
252, 253, and 254 were $32,623,
$25,396, and $21,461, respectively. The
average costs for all cases in MS–DRGs
252, 253, and 254 were $23,935,
$19,030, and $12,629, respectively. The
average costs for the drug-eluting stent
cases in MS–DRG 253 ($25,396) were
higher than the average costs for all
cases in MS–DRG 252 ($23,935).
However, the average costs for the drugeluting stent cases in MS–DRG 254
($21,461) were lower than the average
costs for all cases in MS–DRG 252
($23,935).
We have determined that the small
number of cases (601) does not provide
justification to create a new set of MS–
DRGs specifically for angioplasty of
peripheral arteries using drug-eluting
stents. In addition, the data do not
support assigning all the drug-eluting
stent cases to the highest severity level
(MS–DRG 252), even when there is not
an MCC, because the average costs for
the drug-eluting stent cases in MS–DRG
254 ($21,461) were lower than the
average costs for all cases in MS–DRG
252 ($23,935). The average length of
stay for drug-eluting stent cases in MS–
DRG 254 was 2.62 days compared to
7.89 days for all cases in MS–DRG 252.
Cases are grouped together based on
similar clinical and resource criteria.
Our clinical advisors recommended
making no MS–DRG updates for
peripheral angioplasty cases with a
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drug-eluting stent and considered the
current MS–DRG assignment
appropriate. Our clinical advisors
agreed that the small number of
peripheral angioplasty cases with a
drug-eluting stent does not support
creating a new MS–DRG for this specific
type of treatment. They stated that the
cases are clinically similar to other cases
within MS–DRGs 252, 253, and 254.
Considering the data for peripheral
angioplasty cases with a drug-eluting
stent found reported in MS–DRGs 252,
253, and 254 and the input from our
clinical advisors, we are not proposing
to make any MS–DRG updates for
peripheral angioplasty cases with a
drug-eluting stent. We are proposing to
maintain the current MS–DRG
assignments for these cases in MS–DRGs
252, 253, and 254. We are inviting
public comments on our proposal.
d. Percutaneous Mitral Valve Repair
System—Proposed Revision of ICD–10–
PCS Version 32 Logic
We received a comment which
brought to our attention that the ICD–10
MS–DRGs Version 32 assignment for
ICD–10–PCS procedure code 02UG3JZ
(Supplement mitral valve with synthetic
substitute, percutaneous approach) does
not accurately replicate the ICD–9–CM
MS–DRGs Version 32, which assign this
procedure code to the following MS–
DRGs:
• MS–DRG 231 (Coronary Bypass
with PTCA with MCC);
• MS–DRG 232 (Coronary Bypass
with PTCA without MCC);
• MS–DRG 246 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent with MCC or 4+ Vessels/
Stents);
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30,696
133
34,746
353
15,394
115
Average
length of stay
Average costs
7.89
9.08
5.68
4.99
2.99
2.62
$23,935
32,623
19,030
25,396
12,629
21,461
• MS DRG 247 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent without MCC);
• MS–DRG 248 (Percutaneous
Cardiovascular Procedure with NonDrug-Eluting Stent with MCC or 4+
Vessels/Stents);
• MS DRG 249 (Percutaneous
Cardiovascular Procedure with NonDrug-Eluting Stent without MCC);
• MS–DRG 250 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent with MCC); and
• MS–DRG 251 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent without MCC).
We agree with the commenter that the
ICD–10 MS–DRGs logic should be
consistent with the ICD–9 MS–DRGs
logic; that is, the ICD–10 MS–DRGs
Version 32 should replicate the ICD–9–
CM MS–DRGs Version 32. Therefore, for
the proposed FY 2016 ICD–10 MS–
DRGs Version 33, we are proposing to
assign ICD–10–PCS procedure code
02UG3JZ to MS–DRGs 231 and 232 and
MS–DRGs 246 through 251. We are
inviting public comments on this
proposal.
e. Major Cardiovascular Procedures:
Zenith® Fenestrated Abdominal Aortic
Aneurysm (AAA) Graft
The new technology add-on payment
for the Zenith® Fenestrated Abdominal
Aortic Aneurysm (AAA) Graft (Zenith®
F. Graft) will end on September 30,
2015. Cases involving the Zenith® F.
Graft are identified by ICD–9–CM
procedure code 39.78 (Endovascular
implantation of branching or fenestrated
graft(s) in aorta) in MS–DRGs 237 and
238 (Major Cardiovascular Procedures
with and without MCC, respectively).
For additional information on the
Zenith® F. Graft, we refer readers to the
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FY 2015 IPPS/LTCH PPS final rule (79
FR 49921 through 49922).
We received a request to reassign
procedure code 39.78 to the highest
severity level in MS–DRGs 237 and 238,
including in instances when there is not
an MCC present, or to create a new MS–
DRG that would contain all
endovascular aneurysm repair
procedures. We note that, in addition to
procedure code 39.78, ICD–9–CM
procedure code 39.71 (Endovascular
implantation of other graft in abdominal
aorta) also describes endovascular
aneurysm repair procedures.
There are a number of ICD–10–PCS
code translations that provide more
detailed and specific information for
each of ICD–9–CM codes 39.71 and
39.78 that also currently group to MS–
DRGs 237 and 238 in the ICD–10 MS–
DRGs Version 32. The comparable ICD–
10–PCS code translations for ICD–9–CM
procedure code 39.71 and 39.78 are
shown in the following tables:
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.71
ICD–10–PCS code
04U03JZ
04U04JZ
04V03DZ
04V04DZ
.......................
.......................
.......................
.......................
Code description
Supplement abdominal aorta with synthetic substitute, percutaneous approach.
Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach.
Restriction of abdominal aorta with intraluminal device, percutaneous approach.
Restriction of abdominal aorta with intraluminal device, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.78
ICD–10–PCS code
04793DZ
04794DZ
047A3DZ
047A4DZ
04753DZ
04754DZ
04V03DZ
04V04DZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Dilation of right renal artery with intraluminal device, percutaneous approach.
Dilation of right renal artery with intraluminal device, percutaneous endoscopic approach.
Dilation of left renal artery with intraluminal device, percutaneous approach.
Dilation of left renal artery with intraluminal device, percutaneous endoscopic approach.
Dilation of superior mesenteric artery with intraluminal device, percutaneous approach.
Dilation of superior mesenteric artery with intraluminal device, percutaneous endoscopic approach.
Restriction of abdominal aorta with intraluminal device, percutaneous approach.
Restriction of abdominal aorta with intraluminal device, percutaneous endoscopic approach.
We analyzed claims data reporting
procedure code 39.78 for cases assigned
to MS–DRGs 237 and 238 in the
December 2014 update of the FY 2014
MedPAR file. We found a total of 18,340
cases, with an average length of stay of
9.46 days and average costs of $36,355
in MS–DRG 237. We found 332 cases
reporting procedure code 39.78, with an
average length of stay of 8.46 days and
average costs of $51,397 in MS–DRG
237. For MS–DRG 238, we found a total
of 32,227 cases, with an average length
of stay of 3.72 days and average costs of
$25,087. We found 1,927 cases reporting
procedure code 39.78, with an average
length of stay of 2.52 days and average
costs of $31,739 in MS–DRG 238.
ZENITH FENESTRATED GRAFT PROCEDURES
Number
of cases
MS–DRG
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
237—All cases ............................................................................................................
237—Cases with procedure code 39.78 ....................................................................
238—All cases ............................................................................................................
238—Cases with procedure code 39.78 ....................................................................
As illustrated in the table above, the
results of the data analysis indicate that
the average costs for cases reporting
procedure code 39.78 assigned to MS–
DRG 238 were higher than the average
costs for all cases in MS–DRG 238
($3l,739 compared to $25,087). In
addition, the average costs for the 1,927
cases reporting procedure code 39.78
assigned to MS–DRG 238 were $4,616
less than the costs of all cases assigned
to MS–DRG 237. We determined that
moving cases reporting procedure code
39.78 from MS–DRG 238 to MS–DRG
237 would result in overpayments. We
also note that the average length of stay
for the 1,927 cases reporting procedure
code 39.78 in MS–DRG 238 was 2.52
days in comparison to the average
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length of stay for all cases in MS–DRG
237 of 9.46 days. Our clinical advisors
do not agree with moving cases
reporting procedure code 39.78 to a
higher severity level (with MCC) MS–
DRG.
We believe that the higher average
costs could be attributed to the cost of
the device. The Zenith® F. Graft is the
only fenestrated graft device currently
approved by the FDA. Therefore, this
manufacturer is able to set its own costs
in the market. We point out that the
IPPS is not designed to pay solely for
the cost of devices. More importantly,
moving cases that greatly differ in their
severity of illness and complexity of
resources into a higher severity level
MS–DRG, in the absence of an MCC,
PO 00000
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18,340
332
32,227
1,927
Average
length of stay
9.46
8.46
3.72
2.52
Average
costs
$36,355
51,397
25,087
31,739
would conflict with the objective of the
MS–DRGs, which is to maintain
homogeneous subgroups that are
different from one another in terms of
utilization of resources, that have
enough volume to be meaningful, and
that improve our ability to explain
variance in resource use (72 FR 47169).
Therefore, we are not proposing to
reassign all cases reporting procedure
code 39.78 from MS–DRG 238 to MS–
DRG 237, as the commenter requested.
However, we recognize that the
results of the data analysis also
demonstrated that the average costs for
cases reporting procedure code 39.78
are higher in both MS–DRG 237 and
MS–DRG 238 in comparison to all cases
in each respective MS–DRG. As these
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higher average costs could be
attributable to the cost of the device, we
note the commenter’s concern that the
end of the new technology add-on
payment for Zenith® F. Graft, effective
September 30, 2015, may result in
reduced payment to hospitals and
potentially lead to issues involving
access to care for the subset of
beneficiaries who would benefit from
treatment with the Zenith® F. Graft. We
continued to review the data to explore
other alternatives as we analyzed
additional claims data in response to the
second part of the request from the
commenter; that is, to create a new MS–
DRG that would contain all
endovascular aneurysm repair
procedures.
In our evaluation of the claims data in
response to the request to create a new
MS–DRG, we again reviewed claims
data from the December 2014 update of
the FY 2014 MedPAR file. We began our
analysis by examining claims data for
cases reporting procedure codes 39.71
and 39.78 assigned to MS–DRGs 237
and 238. Our findings are shown in the
table below.
ENDOVASCULAR ABDOMINAL AORTA PROCEDURES
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
237—All cases ............................................................................................................
237—Cases with procedure codes 39.71 and 39.78 .................................................
238—All cases ............................................................................................................
238—Cases with procedure codes 39.71 and 39.78 .................................................
As shown in the table above, the
average costs for endovascular
abdominal aorta aneurysm repair
procedures assigned to MS–DRG 237
were higher than the average costs of all
cases assigned to MS–DRGs 237. The
average costs for cases reporting
procedure codes 39.71 and 39.78
assigned to MS–DRG 237 were $47,363
compared to the average costs of
$36,355 for all cases assigned to MS–
DRG 237 and $25,087 for all cases
assigned to MS–DRG 238. Similarly, the
average costs for cases reporting
procedure codes 39.71 and 39.78
assigned to MS–DRG 238 were higher
than the average costs of all cases
assigned to MS–DRG 238 ($28,998
compared to $25,087). The average
length of stay for cases reporting
procedure codes 39.71 and 39.78 in
MS–DRGs 237 and 238 were also shorter
than the average length of stay for all
cases in the respective MS–DRG.
Our clinical advisors did not support
creating a new MS–DRG specifically for
endovascular abdominal aortic
aneurysm repair procedures only.
Therefore, we reviewed other procedure
codes currently assigned to MS–DRGs
237 and 238 and found that there were
a number of procedures with varying
resource requirements and clinical
indications that could be analyzed
further. We agreed with our clinical
advisors that further analysis was
warranted to determine how we could
better recognize resource utilization,
clinical complexity, and average costs
by separating the more complex, more
invasive, and more expensive
procedures used to treat more severely
ill individuals from the less complex,
less invasive, and less expensive
procedures currently grouped to these
MS–DRGs.
Therefore, we evaluated all of the
procedures currently assigned to MS–
DRGs 237 and 238. In our evaluation,
we found that MS–DRGs 237 and 238
contained two distinct groups of
procedures. We found a high volume of
less invasive procedures, such as
pericardiotomies and pulsation balloon
implants, that had substantially lower
costs than the more invasive
procedures, such as open and
endovascular repairs of the aorta with
replacement grafts. We found that the
more invasive procedures were
primarily associated with procedures on
the aorta and heart assist procedures.
For this next phase of our analysis,
the following procedure codes were
designated as the more complex, more
invasive procedures:
• 37.41 (Implantation of prosthetic
cardiac support device around the
heart);
Average
length of stay
18,340
2,425
32,227
16,502
9.46
8.34
3.72
2.27
Average
costs
$36,355
47,363
25,087
28,998
• 37.49 (Other repair of heart and
pericardium);
• 37.55 (Removal of internal
biventricular heart replacement system);
• 37.64 (Removal of external heart
assist system(s) or device(s));
• 38.04 (Incision of vessel, aorta);
• 38.14 (Endarterectomy, aorta);
• 38.34 (Resection of vessel with
anastomosis, aorta);
• 38.44 (Resection of vessel with
replacement, aorta, abdominal);
• 38.64 (Other excision of vessels,
aorta, abdominal);
• 38.84 (Other surgical occlusion of
vessels, aorta, abdominal);
• 39.24 (Aorta-renal bypass);
• 39.71 (Endovascular implantation
of other graft in abdominal aorta); and
• 39.78 (Endovascular implantation
of branching or fenestrated graft(s) in
aorta).
There are a number of ICD–10–PCS
code translations that provide more
detailed and specific information for
each of the ICD–9–CM codes listed
above that also currently group to MS–
DRGs 237 and 238 in the ICD–10 MS–
DRGs Version 32. The comparable ICD–
10–PCS code translations for these ICD–
9–CM procedure codes are shown in the
following table:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.41
ICD–10–PCS
code
02UA0JZ .......................
02UA3JZ .......................
02UA4JZ .......................
Code description
Supplement heart with synthetic substitute, open approach.
Supplement heart with synthetic substitute, percutaneous approach.
Supplement heart with synthetic substitute, percutaneous endoscopic approach.
For the ICD–9–CM codes that result in
greater than 50 ICD–10–PCS comparable
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code translations, we refer readers to
Table 6P (ICD–10–PCS Code
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Translations for Proposed MS–DRG
Changes) for this proposed rule (which
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is available via the Internet on the CMS
Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-Service-
Payment/AcuteInpatientPPS/
index.html. The table includes the MDC
24365
topic, the ICD–9–CM code, and the ICD–
10–PCS code translations.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.49
ICD–10–PCS
code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 37.49 are shown in Table 6P.1a that is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.55
ICD–10–PCS
code
02PA0QZ ......................
02PA3QZ ......................
02PA4QZ ......................
Code description
Removal of implantable heart assist system from heart, open approach.
Removal of implantable heart assist system from heart, percutaneous approach.
Removal of implantable heart assist system from heart, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.64
ICD–10–PCS
code
02PA0RZ ......................
02PA3RZ ......................
02PA4RZ ......................
Code description
Removal of external heart assist system from heart, open approach.
Removal of external heart assist system from heart, percutaneous approach.
Removal of external heart assist system from heart, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.04
ICD–10–PCS
code
02CW0ZZ .....................
02CW3ZZ .....................
02CW4ZZ .....................
04C00ZZ .......................
04C03ZZ .......................
04C04ZZ .......................
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
from
from
from
from
from
from
thoracic aorta, open approach.
thoracic aorta, percutaneous approach.
thoracic aorta, percutaneous endoscopic approach.
abdominal aorta, open approach.
abdominal aorta, percutaneous approach.
abdominal aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.14
ICD–10–PCS
code
02CW0ZZ .....................
02CW3ZZ .....................
02CW4ZZ .....................
04C00ZZ .......................
04C03ZZ .......................
04C04ZZ .......................
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
from
from
from
from
from
from
thoracic aorta, open approach.
thoracic aorta, percutaneous approach.
thoracic aorta, percutaneous endoscopic approach.
abdominal aorta, open approach.
abdominal aorta, percutaneous approach.
abdominal aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.34
ICD–10–PCS
code
tkelley on DSK3SPTVN1PROD with PROPOSALS2
02BW0ZZ ......................
02BW4ZZ ......................
04B00ZZ .......................
04B04ZZ .......................
Code description
Excision
Excision
Excision
Excision
of
of
of
of
thoracic aorta, open approach.
thoracic aorta, percutaneous endoscopic approach.
abdominal aorta, open approach.
abdominal aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.44
ICD–10–PCS
code
04R007Z .......................
04R00JZ .......................
VerDate Sep<11>2014
Code description
Replacement of abdominal aorta with autologous tissue substitute, open approach.
Replacement of abdominal aorta with synthetic substitute, open approach.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.44—Continued
ICD–10–PCS
code
04R00KZ
04R047Z
04R04JZ
04R04KZ
.......................
.......................
.......................
.......................
Code description
Replacement
Replacement
Replacement
Replacement
of
of
of
of
abdominal
abdominal
abdominal
abdominal
aorta
aorta
aorta
aorta
with
with
with
with
nonautologous tissue substitute, open approach.
autologous tissue substitute, percutaneous endoscopic approach.
synthetic substitute, percutaneous endoscopic approach.
nonautologous tissue substitute, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.64
ICD–10–PCS
code
04500ZZ
04503ZZ
04504ZZ
04B00ZZ
04B03ZZ
04B04ZZ
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Destruction of abdominal aorta, open approach.
Destruction of abdominal aorta, percutaneous approach.
Destruction of abdominal aorta, percutaneous endoscopic approach.
Excision of abdominal aorta, open approach.
Excision of abdominal aorta, percutaneous approach.
Excision of abdominal aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.84
ICD–10–PCS
code
04L00CZ
04L00DZ
04L00ZZ
04L03CZ
04L03DZ
04L03ZZ
04L04CZ
04L04DZ
04L04ZZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
of
of
of
of
of
of
of
of
of
abdominal
abdominal
abdominal
abdominal
abdominal
abdominal
abdominal
abdominal
abdominal
aorta with extraluminal device, open approach.
aorta with intraluminal device, open approach.
aorta, open approach.
aorta with extraluminal device, percutaneous approach.
aorta with intraluminal device, percutaneous approach.
aorta, percutaneous approach.
aorta with extraluminal device, percutaneous endoscopic approach.
aorta with intraluminal device, percutaneous endoscopic approach.
aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.24
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS
code
0410093
0410094
0410095
04100A3
04100A4
04100A5
04100J3
04100J4
04100J5
04100K3
04100K4
04100K5
04100Z3
04100Z4
04100Z5
0410493
0410494
0410495
04104A3
04104A4
04104A5
04104J3
04104J4
04104J5
04104K3
04104K4
04104K5
........................
........................
........................
.......................
.......................
.......................
........................
........................
........................
.......................
.......................
.......................
........................
........................
........................
........................
........................
........................
.......................
.......................
.......................
........................
........................
........................
.......................
.......................
.......................
04104Z3 ........................
04104Z4 ........................
04104Z5 ........................
VerDate Sep<11>2014
Code description
Bypass abdominal aorta to right renal artery with autologous venous tissue, open approach.
Bypass abdominal aorta to left renal artery with autologous venous tissue, open approach.
Bypass abdominal aorta to bilateral renal artery with autologous venous tissue, open approach.
Bypass abdominal aorta to right renal artery with autologous arterial tissue, open approach.
Bypass abdominal aorta to left renal artery with autologous arterial tissue, open approach.
Bypass abdominal aorta to bilateral renal artery with autologous arterial tissue, open approach.
Bypass abdominal aorta to right renal artery with synthetic substitute, open approach.
Bypass abdominal aorta to left renal artery with synthetic substitute, open approach.
Bypass abdominal aorta to bilateral renal artery with synthetic substitute, open approach.
Bypass abdominal aorta to right renal artery with nonautologous tissue substitute, open approach.
Bypass abdominal aorta to left renal artery with nonautologous tissue substitute, open approach.
Bypass abdominal aorta to bilateral renal artery with nonautologous tissue substitute, open approach.
Bypass abdominal aorta to right renal artery, open approach.
Bypass abdominal aorta to left renal artery, open approach.
Bypass abdominal aorta to bilateral renal artery, open approach.
Bypass abdominal aorta to right renal artery with autologous venous tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to left renal artery with autologous venous tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to bilateral renal artery with autologous venous tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to right renal artery with autologous arterial tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to left renal artery with autologous arterial tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to bilateral renal artery with autologous arterial tissue, percutaneous endoscopic approach.
Bypass abdominal aorta to right renal artery with synthetic substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to left renal artery with synthetic substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to bilateral renal artery with synthetic substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to right renal artery with nonautologous tissue substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to left renal artery with nonautologous tissue substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to bilateral renal artery with nonautologous tissue substitute, percutaneous endoscopic approach.
Bypass abdominal aorta to right renal artery, percutaneous endoscopic approach.
Bypass abdominal aorta to left renal artery, percutaneous endoscopic approach.
Bypass abdominal aorta to bilateral renal artery, percutaneous endoscopic approach.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.71
ICD–10–PCS
code
04U03JZ
04U04JZ
04V03DZ
04V04DZ
.......................
.......................
.......................
.......................
Code description
Supplement abdominal aorta with synthetic substitute, percutaneous approach.
Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach.
Restriction of abdominal aorta with intraluminal device, percutaneous approach.
Restriction of abdominal aorta with intraluminal device, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.78
ICD–10–PCS
code
04793DZ
04794DZ
047A3DZ
047A4DZ
04753DZ
04754DZ
04U03JZ
04U04JZ
04V03DZ
04V04DZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Dilation of right renal artery with intraluminal device, percutaneous approach.
Dilation of right renal artery with intraluminal device, percutaneous endoscopic approach.
Dilation of left renal artery with intraluminal device, percutaneous approach.
Dilation of left renal artery with intraluminal device, percutaneous endoscopic approach.
Dilation of superior mesenteric artery with intraluminal device, percutaneous approach.
Dilation of superior mesenteric artery with intraluminal device, percutaneous endoscopic approach.
Supplement abdominal aorta with synthetic substitute, percutaneous approach.
Supplement abdominal aorta with synthetic substitute, percutaneous endoscopic approach.
Restriction of abdominal aorta with intraluminal device, percutaneous approach.
Restriction of abdominal aorta with intraluminal device, percutaneous endoscopic approach.
For the next phase of our analysis, the
procedure codes shown in the following
table were designated as the less
complex, less invasive procedures.
ICD–9–CM PROCEDURE CODES THAT WERE DESIGNATED AS THE LESS COMPLEX, LESS INVASIVE PROCEDURES
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–9–CM
procedure code
35.00 .............................
35.01 .............................
35.02 .............................
35.03 .............................
35.04 .............................
37.12 .............................
37.24 .............................
37.31 .............................
37.61 .............................
37.67 .............................
37.91 .............................
37.99 .............................
38.05 .............................
38.06 .............................
38.07 .............................
38.15 .............................
38.16 .............................
38.35 .............................
38.36 .............................
38.37 .............................
38.46 .............................
38.47 .............................
38.55 .............................
38.65 .............................
38.66 .............................
38.67 .............................
38.85 .............................
38.86 .............................
38.87 .............................
39.0 ...............................
39.1 ...............................
39.21 .............................
39.22 .............................
39.23 .............................
39.25 .............................
39.26 .............................
39.52 .............................
39.54 .............................
39.72 .............................
39.75 .............................
VerDate Sep<11>2014
Code description
Closed heart valvotomy, unspecified valve.
Closed heart valvotomy, aortic valve.
Closed heart valvotomy, mitral valve.
Closed heart valvotomy, pulmonary valve.
Closed heart valvotomy, tricuspid valve.
Pericardiotomy.
Biopsy of pericardium.
Pericardiectomy.
Implant of pulsation balloon.
Implantation of cardiomyostimulation system.
Open chest cardiac massage.
Other operations on heart and pericardium.
Incision of vessel, other thoracic vessels.
Incision of vessel, abdominal arteries.
Incision of vessel, abdominal veins.
Endarterectomy, other thoracic vessels.
Endarterectomy, abdominal arteries.
Resection of vessel with anastomosis, other thoracic vessels.
Resection of vessel with anastomosis, abdominal arteries.
Resection of vessel with anastomosis, abdominal veins.
Resection of vessel with replacement, abdominal arteries.
Resection of vessel with replacement, abdominal veins.
Ligation and stripping of varicose veins, other thoracic vessels.
Other excision of vessels, thoracic vessels.
Other excision of vessels, abdominal arteries.
Other excision of vessels, abdominal veins.
Other surgical occlusion of vessels, thoracic vessels.
Other surgical occlusion of vessels, abdominal arteries.
Other surgical occlusion of vessels, abdominal veins.
Systemic to pulmonary artery shunt.
Intra-abdominal venous shunt.
Caval-pulmonary artery anastomosis.
Aorta-subclavian-carotid bypass.
Other intrathoracic vascular shunt or bypass.
Aorta-iliac-femoral bypass.
Other intra-abdominal vascular shunt or bypass.
Other repair of aneurysm.
Re-entry operation (aorta).
Endovascular (total) embolization or occlusion of head and neck vessels.
Endovascular embolization or occlusion of vessel(s) of head or neck using bare coils.
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ICD–9–CM PROCEDURE CODES THAT WERE DESIGNATED AS THE LESS COMPLEX, LESS INVASIVE PROCEDURES—
Continued
ICD–9–CM
procedure code
39.76 .............................
39.79 .............................
Code description
Endovascular embolization or occlusion of vessel(s) of head or neck using bioactive coils.
Other endovascular procedures on other vessels.
There are a number of ICD–10–PCS
code translations that provide more
detailed and specific information for
each of the ICD–9–CM codes listed in
the table immediately above that also
currently group to MS–DRGs 237 and
238 in the ICD–10 MS–DRGs Version
32. The comparable ICD–10–PCS code
translations for these ICD–9–CM
procedure codes are shown in the
following tables:
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.00
ICD–10–PCS code
02NF3ZZ .......................
02NF4ZZ .......................
02NG3ZZ ......................
02NG4ZZ ......................
02NH3ZZ ......................
02NH4ZZ ......................
02NJ3ZZ .......................
02NJ4ZZ .......................
Code description
Release
Release
Release
Release
Release
Release
Release
Release
aortic valve, percutaneous approach.
aortic valve, percutaneous endoscopic approach.
mitral valve, percutaneous approach.
mitral valve, percutaneous endoscopic approach.
pulmonary valve, percutaneous approach.
pulmonary valve, percutaneous endoscopic approach.
tricuspid valve, percutaneous approach.
tricuspid valve, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.01
ICD–10–PCS code
02CF3ZZ
02CF4ZZ
02NF3ZZ
02NF4ZZ
.......................
.......................
.......................
.......................
Code description
Extirpation of matter from aortic valve, percutaneous approach.
Extirpation of matter from aortic valve, percutaneous endoscopic approach.
Release aortic valve, percutaneous approach.
Release aortic valve, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATION FOR ICD–9–CM PROCEDURE CODE 35.02
ICD–10–PCS code
02CG3ZZ
02CG4ZZ
02NG3ZZ
02NG4ZZ
......................
......................
......................
......................
Code description
Extirpation of matter from mitral valve, percutaneous approach.
Extirpation of matter from mitral valve, percutaneous endoscopic approach.
Release mitral valve, percutaneous approach.
Release mitral valve, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.03
ICD–10–PCS code
02CH3ZZ
02CH4ZZ
02NH3ZZ
02NH4ZZ
......................
......................
......................
......................
Code description
Extirpation of matter from pulmonary valve, percutaneous approach.
Extirpation of matter from pulmonary valve, percutaneous endoscopic approach.
Release Pulmonary Valve, Percutaneous Approach.
Release Pulmonary Valve, Percutaneous Endoscopic Approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 35.04
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
02CJ3ZZ
02CJ4ZZ
02NJ3ZZ
02NJ4ZZ
.......................
.......................
.......................
.......................
Description
Extirpation of matter from tricuspid valve, percutaneous approach.
Extirpation of matter from tricuspid valve, percutaneous endoscopic approach.
Release tricuspid valve, percutaneous approach.
Release tricuspid valve, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.12
ICD–10–PCS code
02CN0ZZ ......................
02CN3ZZ ......................
VerDate Sep<11>2014
Code description
Extirpation of matter from pericardium, open approach.
Extirpation of matter from pericardium, percutaneous approach.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.12—Continued
ICD–10–PCS code
02CN4ZZ ......................
02HN00Z ......................
02HN02Z ......................
02HN30Z ......................
02HN32Z ......................
02HN40Z ......................
02HN42Z ......................
02NN0ZZ ......................
02NN3ZZ ......................
02NN4ZZ ......................
0W9D00Z ......................
0W9D0ZX .....................
0W9D0ZZ .....................
0WCD0ZZ .....................
0WCD3ZZ .....................
0WCD4ZZ .....................
0WHD03Z .....................
0WHD0YZ .....................
0WHD33Z .....................
0WHD3YZ .....................
0WHD43Z .....................
0WHD4YZ .....................
0WPD00Z .....................
0WPD01Z .....................
0WPD03Z .....................
0WPD0YZ .....................
0WPD30Z .....................
0WPD31Z .....................
0WPD33Z .....................
0WPD3YZ .....................
0WPD40Z .....................
0WPD41Z .....................
0WPD43Z .....................
0WPD4YZ .....................
0WWD00Z ....................
0WWD01Z ....................
0WWD03Z ....................
0WWD0YZ ....................
0WWD30Z ....................
0WWD31Z ....................
0WWD33Z ....................
0WWD3YZ ....................
0WWD40Z ....................
0WWD41Z ....................
0WWD43Z ....................
0WWD4YZ ....................
Code description
Extirpation of matter from pericardium, percutaneous endoscopic approach.
Insertion of pressure sensor monitoring device into pericardium, open approach.
Insertion of monitoring device into pericardium, open approach.
Insertion of pressure sensor monitoring device into pericardium, percutaneous approach.
Insertion of monitoring device into pericardium, percutaneous approach.
Insertion of pressure sensor monitoring device into pericardium, percutaneous endoscopic approach.
Insertion of monitoring device into pericardium, percutaneous endoscopic approach.
Release pericardium, open approach.
Release pericardium, percutaneous approach.
Release pericardium, percutaneous endoscopic approach.
Drainage of pericardial cavity with drainage device, open approach.
Drainage of pericardial cavity, open approach, diagnostic.
Drainage of pericardial cavity, open approach.
Extirpation of matter from pericardial cavity, open approach.
Extirpation of matter from pericardial cavity, percutaneous approach.
Extirpation of matter from pericardial cavity, percutaneous endoscopic approach.
Insertion of infusion device into pericardial cavity, open approach.
Insertion of other device into pericardial cavity, open approach.
Insertion of infusion device into pericardial cavity, percutaneous approach.
Insertion of other device into pericardial cavity, percutaneous approach.
Insertion of infusion device into pericardial cavity, percutaneous endoscopic approach.
Insertion of other device into pericardial cavity, percutaneous endoscopic approach.
Removal of drainage device from pericardial cavity, open approach.
Removal of radioactive element from pericardial cavity, open approach.
Removal of infusion device from pericardial cavity, open approach.
Removal of other device from pericardial cavity, open approach.
Removal of drainage device from pericardial cavity, percutaneous approach.
Removal of radioactive element from pericardial cavity, percutaneous approach.
Removal of infusion device from pericardial cavity, percutaneous approach.
Removal of other device from pericardial cavity, percutaneous approach.
Removal of drainage device from pericardial cavity, percutaneous endoscopic approach.
Removal of radioactive element from pericardial cavity, percutaneous endoscopic approach.
Removal of infusion device from pericardial cavity, percutaneous endoscopic approach.
Removal of other device from pericardial cavity, percutaneous endoscopic approach.
Revision of drainage device in pericardial cavity, open approach.
Revision of radioactive element in pericardial cavity, open approach.
Revision of infusion device in pericardial cavity, open approach.
Revision of other device in pericardial cavity, open approach.
Revision of drainage device in pericardial cavity, percutaneous approach.
Revision of radioactive element in pericardial cavity, percutaneous approach.
Revision of infusion device in pericardial cavity, percutaneous approach.
Revision of other device in pericardial cavity, percutaneous approach.
Revision of drainage device in pericardial cavity, percutaneous endoscopic approach.
Revision of radioactive element in pericardial cavity, percutaneous endoscopic approach.
Revision of infusion device in pericardial cavity, percutaneous endoscopic approach.
Revision of other device in pericardial cavity, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.24
ICD–10–PCS code
02BN0ZX ......................
02BN3ZX ......................
02BN4ZX ......................
Code description
Excision of pericardium, open approach, diagnostic
Excision of pericardium, percutaneous approach, diagnostic
Excision of pericardium, percutaneous endoscopic approach, diagnostic
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.31
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
025N0ZZ
025N3ZZ
025N4ZZ
02BN0ZZ
02BN3ZZ
02BN4ZZ
02TN0ZZ
02TN3ZZ
02TN4ZZ
.......................
.......................
.......................
......................
......................
......................
.......................
.......................
.......................
VerDate Sep<11>2014
Code description
Destruction of pericardium, open approach.
Destruction of pericardium, percutaneous approach.
Destruction of pericardium, percutaneous endoscopic approach.
Excision of pericardium, open approach.
Excision of pericardium, percutaneous approach.
Excision of pericardium, percutaneous endoscopic approach.
Resection of pericardium, open approach.
Resection of pericardium, percutaneous approach.
Resection of pericardium, percutaneous endoscopic approach.
18:20 Apr 29, 2015
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24369
24370
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.61
ICD–10–PCS code
5A02110 .......................
5A02210 .......................
Code description
Assistance with cardiac output using balloon pump, intermittent.
Assistance with cardiac output using balloon pump, continuous.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.67
ICD–10–PCS code
02QA0ZZ ......................
02QA3ZZ ......................
02QA4ZZ ......................
Code description
Repair heart, open approach.
Repair heart, percutaneous approach.
Repair heart, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.91
ICD–10–PCS code
02QA0ZZ ......................
Code description
Repair heart, open approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 37.99
ICD–10–PCS code
02880ZZ .......................
02883ZZ .......................
02884ZZ .......................
Code description
Division of conduction mechanism, open approach.
Division of conduction mechanism, percutaneous approach.
Division of conduction mechanism, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.05
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.05 are shown in Table 6P.1b for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.06
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
04C10ZZ
04C13ZZ
04C14ZZ
04C20ZZ
04C23ZZ
04C24ZZ
04C30ZZ
04C33ZZ
04C34ZZ
04C40ZZ
04C43ZZ
04C44ZZ
04C50ZZ
04C53ZZ
04C54ZZ
04C60ZZ
04C63ZZ
04C64ZZ
04C70ZZ
04C73ZZ
04C74ZZ
04C80ZZ
04C83ZZ
04C84ZZ
04C90ZZ
04C93ZZ
04C94ZZ
04CA0ZZ
04CA3ZZ
04CA4ZZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
......................
......................
......................
VerDate Sep<11>2014
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
18:20 Apr 29, 2015
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matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
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matter
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matter
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matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
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PO 00000
celiac artery, open approach.
celiac artery, percutaneous approach.
celiac artery, percutaneous endoscopic approach.
gastric artery, open approach.
gastric artery, percutaneous approach.
gastric artery, percutaneous endoscopic approach.
hepatic artery, open approach.
hepatic artery, percutaneous approach.
hepatic artery, percutaneous endoscopic approach.
splenic artery, open approach.
splenic artery, percutaneous approach.
splenic artery, percutaneous endoscopic approach.
superior mesenteric artery, open approach.
superior mesenteric artery, percutaneous approach.
superior mesenteric artery, percutaneous endoscopic approach.
right colic artery, open approach.
right colic artery, percutaneous approach.
right colic artery, percutaneous endoscopic approach.
left colic artery, open approach.
left colic artery, percutaneous approach.
left colic artery, percutaneous endoscopic approach.
middle colic artery, open approach.
middle colic artery, percutaneous approach.
middle colic artery, percutaneous endoscopic approach.
right renal artery, open approach.
right renal artery, percutaneous approach.
right renal artery, percutaneous endoscopic approach.
left renal artery, open approach.
left renal artery, percutaneous approach.
left renal artery, percutaneous endoscopic approach.
Frm 00048
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30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.06—Continued
ICD–10–PCS code
04CB0ZZ ......................
04CB3ZZ ......................
04CB4ZZ ......................
04CC0ZZ ......................
04CC3ZZ ......................
04CC4ZZ ......................
04CD0ZZ ......................
04CD3ZZ ......................
04CD4ZZ ......................
04CE0ZZ ......................
04CE3ZZ ......................
04CE4ZZ ......................
04CF0ZZ .......................
04CF3ZZ .......................
04CF4ZZ .......................
04CH0ZZ ......................
04CH3ZZ ......................
04CH4ZZ ......................
04CJ0ZZ .......................
04CJ3ZZ .......................
04CJ4ZZ .......................
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
inferior mesenteric artery, open approach.
inferior mesenteric artery, percutaneous approach.
inferior mesenteric artery, percutaneous endoscopic approach.
right common iliac artery, open approach.
right common iliac artery, percutaneous approach.
right common iliac artery, percutaneous endoscopic approach.
left common iliac artery, open approach.
left common iliac artery, percutaneous approach.
left common iliac artery, percutaneous endoscopic approach.
right internal iliac artery, open approach.
right internal iliac artery, percutaneous approach.
right internal iliac artery, percutaneous endoscopic approach.
left internal iliac artery, open approach.
left internal iliac artery, percutaneous approach.
left internal iliac artery, percutaneous endoscopic approach.
right external iliac artery, open approach.
right external iliac artery, percutaneous approach.
right external iliac artery, percutaneous endoscopic approach.
left external iliac artery, open approach.
left external iliac artery, percutaneous approach.
left external iliac artery, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.07
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
06C00ZZ .......................
06C03ZZ .......................
06C04ZZ .......................
06C10ZZ .......................
06C13ZZ .......................
06C14ZZ .......................
06C20ZZ .......................
06C23ZZ .......................
06C24ZZ .......................
06C40ZZ .......................
06C43ZZ .......................
06C44ZZ .......................
06C50ZZ .......................
06C53ZZ .......................
06C54ZZ .......................
06C60ZZ .......................
06C63ZZ .......................
06C64ZZ .......................
06C70ZZ .......................
06C73ZZ .......................
06C74ZZ .......................
06C80ZZ .......................
06C83ZZ .......................
06C84ZZ .......................
06C90ZZ .......................
06C93ZZ .......................
06C94ZZ .......................
06CB0ZZ ......................
06CB3ZZ ......................
06CB4ZZ ......................
06CC0ZZ ......................
06CC3ZZ ......................
06CC4ZZ ......................
06CD0ZZ ......................
06CD3ZZ ......................
06CD4ZZ ......................
06CF0ZZ .......................
06CF3ZZ .......................
06CF4ZZ .......................
06CG0ZZ ......................
06CG3ZZ ......................
06CG4ZZ ......................
06CH0ZZ ......................
06CH3ZZ ......................
06CH4ZZ ......................
VerDate Sep<11>2014
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
18:20 Apr 29, 2015
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of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
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matter
matter
matter
matter
matter
matter
matter
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matter
matter
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matter
matter
matter
Jkt 235001
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PO 00000
inferior vena cava, open approach.
inferior vena cava, percutaneous approach.
inferior vena vava, percutaneous endoscopic approach.
splenic vein, open approach.
splenic vein, percutaneous approach.
splenic vein, percutaneous endoscopic approach.
gastric vein, open approach.
gastric vein, percutaneous approach.
gastric vein, percutaneous endoscopic approach.
hepatic vein, open approach.
hepatic vein, percutaneous approach.
hepatic vein, percutaneous endoscopic approach.
superior mesenteric vein, open approach.
superior mesenteric vein, percutaneous approach.
superior mesenteric vein, percutaneous endoscopic approach.
inferior mesenteric vein, open approach.
inferior mesenteric vein, percutaneous approach.
inferior mesenteric vein, percutaneous endoscopic approach.
colic vein, open approach.
colic vein, percutaneous approach.
colic vein, percutaneous endoscopic approach.
portal vein, open approach.
portal vein, percutaneous approach.
portal vein, percutaneous endoscopic approach.
right renal vein, open approach.
right renal vein, percutaneous approach.
right renal vein, percutaneous endoscopic approach.
left renal vein, open approach.
left renal vein, percutaneous approach.
left renal vein, percutaneous endoscopic approach.
right common iliac vein, open approach.
right common iliac vein, percutaneous approach.
right common iliac vein, percutaneous endoscopic approach.
left common iliac vein, open approach.
left common iliac vein, percutaneous approach.
left common iliac vein, percutaneous endoscopic approach.
right external iliac vein, open approach.
right external iliac vein, percutaneous approach.
right external iliac vein, percutaneous endoscopic approach.
left external iliac vein, open approach.
left external iliac vein, percutaneous approach.
left external iliac vein, percutaneous endoscopic approach.
right hypogastric vein, open approach.
right hypogastric vein, percutaneous approach.
right hypogastric vein, percutaneous endoscopic approach.
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24371
24372
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.07—Continued
ICD–10–PCS code
06CJ0ZZ .......................
06CJ3ZZ .......................
06CJ4ZZ .......................
Code description
Extirpation of matter from left hypogastric vein, open approach.
Extirpation of matter from left hypogastric vein, percutaneous approach.
Extirpation of matter from left hypogastric vein, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.15
ICD–10–PCS code
02CP0ZZ ......................
02CP3ZZ ......................
02CP4ZZ ......................
02CQ0ZZ ......................
02CQ3ZZ ......................
02CQ4ZZ ......................
02CR0ZZ ......................
02CR3ZZ ......................
02CR4ZZ ......................
02CS0ZZ ......................
02CS3ZZ ......................
02CS4ZZ ......................
02CT0ZZ .......................
02CT3ZZ .......................
02CT4ZZ .......................
02CV0ZZ ......................
02CV3ZZ ......................
02CV4ZZ ......................
03C00ZZ .......................
03C03ZZ .......................
03C04ZZ .......................
03C10ZZ .......................
03C13ZZ .......................
03C14ZZ .......................
03C20ZZ .......................
03C23ZZ .......................
03C24ZZ .......................
03C30ZZ .......................
03C33ZZ .......................
03C34ZZ .......................
03C40ZZ .......................
03C43ZZ .......................
03C44ZZ .......................
Code description
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
from
from
from
from
from
from
from
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from
from
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from
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from
pulmonary trunk, open approach.
pulmonary trunk, percutaneous approach.
pulmonary trunk, percutaneous endoscopic approach.
right pulmonary artery, open approach.
right pulmonary artery, percutaneous approach.
right pulmonary artery, percutaneous endoscopic approach.
left pulmonary artery, open approach.
left pulmonary artery, percutaneous approach.
left pulmonary artery, percutaneous endoscopic approach.
right pulmonary vein, open approach.
right pulmonary vein, percutaneous approach.
right pulmonary vein, percutaneous endoscopic approach.
left pulmonary vein, open approach.
left pulmonary vein, percutaneous approach.
left pulmonary vein, percutaneous endoscopic approach.
superior vena cava, open approach.
superior vena cava, percutaneous approach.
superior vena cava, percutaneous endoscopic approach.
right internal mammary artery, open approach.
right internal mammary artery, percutaneous approach.
right internal mammary artery, percutaneous endoscopic approach.
left internal mammary artery, open approach.
left internal mammary artery, percutaneous approach.
left internal mammary artery, percutaneous endoscopic approach.
innominate artery, open approach.
innominate artery, percutaneous approach.
innominate artery, percutaneous endoscopic approach.
right subclavian artery, open approach.
right subclavian artery, percutaneous approach.
right subclavian artery, percutaneous endoscopic approach.
left subclavian artery, open approach.
left subclavian artery, percutaneous approach.
left subclavian artery, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.16
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.16 are shown in Table 6P.1c for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.35
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
02BP0ZZ .......................
02BP4ZZ .......................
02BQ0ZZ ......................
02BQ4ZZ ......................
02BR0ZZ ......................
02BR4ZZ ......................
02BS0ZZ .......................
02BS4ZZ .......................
02BT0ZZ .......................
02BT4ZZ .......................
02BV0ZZ .......................
02BV4ZZ .......................
03B00ZZ .......................
03B04ZZ .......................
03B10ZZ .......................
VerDate Sep<11>2014
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
18:20 Apr 29, 2015
of
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of
of
of
of
of
of
of
of
of
of
of
of
of
pulmonary trunk, open approach.
pulmonary trunk, percutaneous endoscopic approach.
right pulmonary artery, open approach.
right pulmonary artery, percutaneous endoscopic approach.
left pulmonary artery, open approach.
left pulmonary artery, percutaneous endoscopic approach.
right pulmonary vein, open approach.
right pulmonary vein, percutaneous endoscopic approach.
left pulmonary vein, open approach.
left pulmonary vein, percutaneous endoscopic approach.
superior vena cava, open approach.
superior vena cava, percutaneous endoscopic approach.
right internal mammary artery, open approach.
right internal mammary artery, percutaneous endoscopic approach.
left internal mammary artery, open approach.
Jkt 235001
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Fmt 4701
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30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.35—Continued
ICD–10–PCS code
03B14ZZ
03B20ZZ
03B24ZZ
03B30ZZ
03B34ZZ
03B40ZZ
03B44ZZ
05B00ZZ
05B04ZZ
05B10ZZ
05B14ZZ
05B30ZZ
05B34ZZ
05B40ZZ
05B44ZZ
05B50ZZ
05B54ZZ
05B60ZZ
05B64ZZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
left internal mammary artery, percutaneous endoscopic approach.
innominate artery, open approach.
innominate artery, percutaneous endoscopic approach.
right subclavian artery, open approach.
right subclavian artery, percutaneous endoscopic approach.
left subclavian artery, open approach.
left subclavian artery, percutaneous endoscopic approach.
azygos vein, open approach.
azygos vein, percutaneous endoscopic approach.
hemiazygos vein, open approach.
hemiazygos vein, percutaneous endoscopic approach.
right innominate vein, open approach.
right innominate vein, percutaneous endoscopic approach.
left innominate vein, open approach.
left innominate vein, percutaneous endoscopic approach.
right subclavian vein, open approach.
right subclavian vein, percutaneous endoscopic approach.
left subclavian vein, open approach.
left subclavian vein, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.36
ICD–10–PCS code
04B10ZZ
04B14ZZ
04B20ZZ
04B24ZZ
04B30ZZ
04B34ZZ
04B40ZZ
04B44ZZ
04B50ZZ
04B54ZZ
04B60ZZ
04B64ZZ
04B70ZZ
04B74ZZ
04B80ZZ
04B84ZZ
04B90ZZ
04B94ZZ
04BA0ZZ
04BA4ZZ
04BB0ZZ
04BB4ZZ
04BC0ZZ
04BC4ZZ
04BD0ZZ
04BD4ZZ
04BE0ZZ
04BE4ZZ
04BF0ZZ
04BF4ZZ
04BH0ZZ
04BH4ZZ
04BJ0ZZ
04BJ4ZZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
......................
......................
......................
......................
.......................
.......................
.......................
.......................
......................
......................
.......................
.......................
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
celiac artery, open approach.
celiac artery, percutaneous endoscopic approach.
gastric artery, open approach.
gastric artery, percutaneous endoscopic approach.
hepatic artery, open approach.
hepatic artery, percutaneous endoscopic approach.
splenic artery, open approach.
splenic artery, percutaneous endoscopic approach.
superior mesenteric artery, open approach.
superior mesenteric artery, percutaneous endoscopic approach.
right colic artery, open approach.
right colic artery, percutaneous endoscopic approach.
left colic artery, open approach.
left colic artery, percutaneous endoscopic approach.
middle colic artery, open approach.
middle colic artery, percutaneous endoscopic approach.
right renal artery, open approach.
right renal artery, percutaneous endoscopic approach.
left renal artery, open approach.
left renal artery, percutaneous endoscopic approach.
inferior mesenteric artery, open approach.
inferior mesenteric artery, percutaneous endoscopic approach.
right common iliac artery, open approach.
right common iliac artery, percutaneous endoscopic approach.
left common iliac artery, open approach.
left common iliac artery, percutaneous endoscopic approach.
right internal iliac artery, open approach.
right internal iliac artery, percutaneous endoscopic approach.
left internal iliac artery, open approach.
left internal iliac artery, percutaneous endoscopic approach.
right external iliac artery, open approach.
right external iliac artery, percutaneous endoscopic approach.
left external iliac artery, open approach.
left external iliac artery, percutaneous endoscopic approach.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.37
ICD–10–PCS code
06B00ZZ
06B04ZZ
06B10ZZ
06B14ZZ
06B20ZZ
06B24ZZ
06B40ZZ
.......................
.......................
.......................
.......................
.......................
.......................
.......................
VerDate Sep<11>2014
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
18:20 Apr 29, 2015
of
of
of
of
of
of
of
inferior vena cava, open approach.
inferior vena cava, percutaneous endoscopic approach.
splenic vein, open approach.
splenic vein, percutaneous endoscopic approach.
gastric vein, open approach.
gastric vein, percutaneous endoscopic approach.
hepatic vein, open approach.
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24373
24374
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.37—Continued
ICD–10–PCS code
06B44ZZ .......................
06B50ZZ .......................
06B54ZZ .......................
06B60ZZ .......................
06B64ZZ .......................
06B70ZZ .......................
06B74ZZ .......................
06B80ZZ .......................
06B84ZZ .......................
06B90ZZ .......................
06B94ZZ .......................
06BB0ZZ .......................
06BB4ZZ .......................
06BC0ZZ ......................
06BC4ZZ ......................
06BD0ZZ ......................
06BD4ZZ ......................
06BF0ZZ .......................
06BF4ZZ .......................
06BG0ZZ ......................
06BG4ZZ ......................
06BH0ZZ ......................
06BH4ZZ ......................
06BJ0ZZ .......................
06BJ4ZZ .......................
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
hepatic vein, percutaneous endoscopic approach.
superior mesenteric vein, open approach.
superior mesenteric vein, percutaneous endoscopic approach.
inferior mesenteric vein, open approach.
inferior mesenteric vein, percutaneous endoscopic approach.
colic vein, open approach.
colic vein, percutaneous endoscopic approach.
portal vein, open approach.
portal vein, percutaneous endoscopic approach.
right renal vein, open approach.
right renal vein, percutaneous endoscopic approach.
left renal vein, open approach.
left renal vein, percutaneous endoscopic approach.
right common iliac vein, open approach.
right common iliac vein, percutaneous endoscopic approach.
left common iliac vein, open approach.
left common iliac vein, percutaneous endoscopic approach.
right external iliac vein, open approach.
right external iliac vein, percutaneous endoscopic approach.
left external iliac vein, open approach.
left external iliac vein, percutaneous endoscopic approach.
right hypogastric vein, open approach.
right hypogastric vein, percutaneous endoscopic approach.
left hypogastric vein, open approach.
left hypogastric vein, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.46
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.46 are shown in Table 6P.1d for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.47
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.47 are shown in Table 6P.1e for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
There is not an equivalent ICD–10–
PCS code translation for ICD–9–CM
procedure code 38.55.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.65
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.65 are shown in Table 6P.1f for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.66
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.66 are shown in Table 6P.1g for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
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24375
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.67
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.67 are shown in Table 6P.1h for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.85
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.85 are shown in Table 6P.1i for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.86
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.86 are shown in Table 6P.1j for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 38.87
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 38.87 are shown in Table 6P.1k for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.0
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.0 are shown in Table 6P.1l for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.1
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.1 are shown in Table 6P.1m for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.21
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
Code description
021V09P .......................
021V09Q .......................
021V09R .......................
021V0AP .......................
021V0AQ ......................
021V0AR ......................
021V0JP .......................
021V0JQ .......................
021V0JR .......................
021V0KP .......................
021V0KQ ......................
021V0KR ......................
021V0ZP .......................
021V0ZQ ......................
021V0ZR .......................
021V49P .......................
021V49Q .......................
Bypass superior vena cava to pulmonary trunk with autologous venous tissue, open approach.
Bypass superior vena cava to right pulmonary artery with autologous venous tissue, open approach.
Bypass superior vena cava to left pulmonary artery with autologous venous tissue, open approach.
Bypass superior vena cava to pulmonary trunk with autologous arterial tissue, open approach.
Bypass superior vena cava to right pulmonary artery with autologous arterial tissue, open approach.
Bypass superior vena cava to left pulmonary artery with autologous arterial tissue, open approach.
Bypass superior vena cava to pulmonary trunk with synthetic substitute, open approach.
Bypass superior vena cava to right pulmonary artery with synthetic substitute, open approach.
Bypass superior vena cava to left pulmonary artery with synthetic substitute, open approach.
Bypass superior vena cava to pulmonary trunk with nonautologous tissue substitute, open approach.
Bypass superior vena cava to right pulmonary artery with nonautologous tissue substitute, open approach.
Bypass superior vena cava to left pulmonary artery with nonautologous tissue substitute, open approach.
Bypass superior vena cava to pulmonary trunk, open approach.
Bypass superior vena cava to right pulmonary artery, open approach.
Bypass superior vena cava to left pulmonary artery, open approach.
Bypass superior vena cava to pulmonary trunk with autologous venous tissue, percutaneous endoscopic approach.
Bypass superior vena cava to right pulmonary artery with autologous venous tissue, percutaneous endoscopic approach.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.21—Continued
ICD–10–PCS code
Code description
021V49R .......................
Bypass superior vena cava to left pulmonary artery with autologous venous tissue, percutaneous endoscopic approach.
Bypass superior vena cava to pulmonary trunk with autologous arterial tissue, percutaneous endoscopic approach.
Bypass superior vena cava to right pulmonary artery with autologous arterial tissue, percutaneous endoscopic approach.
Bypass superior vena cava to left pulmonary artery with autologous arterial tissue, percutaneous endoscopic approach.
Bypass superior vena cava to pulmonary trunk with synthetic substitute, percutaneous endoscopic approach.
Bypass superior vena cava to right pulmonary artery with synthetic substitute, percutaneous endoscopic approach.
Bypass superior vena cava to left pulmonary artery with synthetic substitute, percutaneous endoscopic approach.
Bypass superior vena cava to pulmonary trunk with nonautologous tissue substitute, percutaneous endoscopic approach.
Bypass superior vena cava to right pulmonary artery with nonautologous tissue substitute, percutaneous endoscopic
approach.
Bypass superior vena cava to left pulmonary artery with nonautologous tissue substitute, percutaneous endoscopic
approach.
Bypass superior vena cava to pulmonary trunk, percutaneous endoscopic approach.
Bypass superior vena cava to right pulmonary artery, percutaneous endoscopic approach.
Bypass superior vena cava to left pulmonary artery, percutaneous endoscopic approach.
021V4AP .......................
021V4AQ ......................
021V4AR ......................
021V4JP
021V4JQ
021V4JR
021V4KP
.......................
.......................
.......................
.......................
021V4KQ ......................
021V4KR ......................
021V4ZP .......................
021V4ZQ ......................
021V4ZR .......................
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.22
ICD–10–PCS code
021W09B
021W09D
021W0AB
021W0AD
021W0JB
021W0JD
021W0KB
021W0KD
021W0ZB
021W0ZD
021W49B
021W49D
021W4AB
021W4AD
021W4JB
021W4JD
021W4KB
021W4KD
021W4ZB
021W4ZD
......................
......................
......................
.....................
......................
......................
......................
.....................
......................
......................
......................
......................
......................
.....................
......................
......................
......................
.....................
......................
......................
Code description
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
Bypass
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
thoracic
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
aorta
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
to
subclavian with autologous venous tissue, open approach).
carotid with autologous venous tissue, open approach).
subclavian with autologous arterial tissue, open approach.
carotid with autologous arterial tissue, open approach.
subclavian with synthetic substitute, open approach.
carotid with synthetic substitute, open approach.
subclavian with nonautologous tissue substitute, open approach.
carotid with nonautologous tissue substitute, open approach.
subclavian, open approach.
carotid, open approach.
subclavian with autologous venous tissue, percutaneous endoscopic approach.
carotid with autologous venous tissue, percutaneous endoscopic approach.
subclavian with autologous arterial tissue, percutaneous endoscopic approach.
carotid with autologous arterial tissue, percutaneous endoscopic approach.
subclavian with synthetic substitute, percutaneous endoscopic approach.
carotid with synthetic substitute, percutaneous endoscopic approach.
subclavian with nonautologous tissue substitute, percutaneous endoscopic approach.
carotid with nonautologous tissue substitute, percutaneous endoscopic approach.
subclavian, percutaneous endoscopic approach.
carotid, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.23
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.23 are shown in Table 6P.1n for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.25
ICD–10–PCS code
Code description
tkelley on DSK3SPTVN1PROD with PROPOSALS2
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.25 are shown in Table 6P.1o for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.26
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.26 are shown in Table 6P.1p for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
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ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.52
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.52 are shown in Table 6P.1q for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.54
ICD–10–PCS code
02QW0ZZ .....................
02QW3ZZ .....................
02QW4ZZ .....................
Code description
Repair thoracic aorta, open approach.
Repair thoracic aorta, percutaneous approach.
Repair thoracic aorta, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.72
ICD–10–PCS code
03LR0DZ
03LR3DZ
03LR4DZ
03LS0DZ
03LS3DZ
03LS4DZ
03LT0DZ
03LT3DZ
03LT4DZ
......................
......................
......................
.......................
.......................
.......................
.......................
.......................
.......................
Code description
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
of
of
of
of
of
of
of
of
of
face artery with intraluminal device, open approach.
face artery with intraluminal device, percutaneous approach.
face artery with intraluminal device, percutaneous endoscopic approach.
right temporal artery with intraluminal device, open approach.
right temporal artery with intraluminal device, percutaneous approach.
right temporal artery with intraluminal device, percutaneous endoscopic approach.
left temporal artery with intraluminal device, open approach.
left temporal artery with intraluminal device, percutaneous approach.
left temporal artery with intraluminal device, percutaneous endoscopic approach.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.75
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.75 are shown in Table 6P.1r for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.76
ICD–10–PCS code
Code description
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.76 are shown in Table 6P.1s for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
ICD–10–PCS CODE TRANSLATIONS FOR ICD–9–CM PROCEDURE CODE 39.79
ICD–10–PCS code
Code description
tkelley on DSK3SPTVN1PROD with PROPOSALS2
The comparable ICD–10–PCS code translations for ICD–9–CM procedure code 39.79 are shown in Table 6P.1t for this proposed rule, which is
available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/
index.html.
As previously stated, we separated the
more complex, more invasive
procedures from the less complex, less
invasive procedures to continue our
evaluation of the procedures assigned to
MS–DRGs 237 and 238. Our data
analysis showed that the distribution of
cases, the average length of stay, and
average costs of the more complex, more
invasive aortic and heart assist
procedures and the less complex, less
invasive other cardiovascular
procedures would be more
appropriately reflected if we classified
these distinguishing types of procedures
under newly created MS–DRGs, as
reflected in the table below.
MAJOR CARDIOVASCULAR PROCEDURES WITH AND WITHOUT MCC
Number
of cases
MS–DRG
MS–DRGs 237 and 238—Combined ..........................................................................................
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30APP2
Average
length of stay
5.8
Average
costs
$29,174
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MAJOR CARDIOVASCULAR PROCEDURES WITH AND WITHOUT MCC—Continued
Number
of cases
MS–DRG
MS–DRGs 237 and 238—Cases with more complex, more invasive procedure codes (37.41;
37.49; 37.55; 37.64; 38.04; 38.14; 38.34; 38.44; 38.64; 38.84; 39.24; 39.71, and 39.78) .....
MS–DRGs 237 and 238—Cases with less complex, less invasive procedure codes (35.00;
35.01; 35.02; 35.03; 35.04; 37.12; 37.24; 37.31; 37.61; 37.67; 37.91; 37.99; 38.05; 38.06;
38.07; 38.15; 38.16; 38.35; 38.36; 38.37; 38.46; 38.47; 38.55; 38.65; 38.66; 38.67; 38.85;
38.86; 38.87; 39.0; 39.1; 39.21; 39.22; 39.23; 39.25; 39.26; 39.52; 39.54; 39.72; 39.75;
39.76; and 39.79) .....................................................................................................................
Our clinical advisors reviewed the
results of the analysis and agreed that
distinguishing the more complex, more
invasive procedures from the less
complex, less invasive procedures
would result in improved clinical
coherence for the various cardiovascular
procedures currently assigned to MS–
DRGs 237 and 238, as listed previously.
Therefore, for FY 2016, we are
proposing to delete MS–DRGs 237 and
238. When we applied our established
criteria to determine if the creation of a
new CC or MCC subgroup within a base
MS–DRG is warranted, we determined
that a 2-way severity level split (with
MCC and without MCC) was justified.
Therefore, we are proposing to create
two new MS–DRGs that would contain
the more complex, more invasive aortic
and heart assist procedures currently
assigned to MS–DRGs 237 and 238, as
listed previously. We are proposing to
create MS–DRG 268, entitled ‘‘Aortic
Average
length of stay
Average
costs
22,278
4.0
31,729
28,289
7.1
27,162
and Heart Assist Procedures Except
Pulsation Balloon with MCC,’’ and MS–
DRG 269, entitled ‘‘Aortic and Heart
Assist Procedures Except Pulsation
Balloon without MCC.’’ The table below
shows the distribution of cases and the
average length of stay and average costs
of the more complex, more invasive
procedures for aortic and heart
assistance for the proposed new MS–
DRGs 268 and 269.
PROPOSED NEW MS–DRGS FOR AORTIC AND HEART ASSIST PROCEDURES
Number
of cases
MS–DRG
Proposed New MS–DRG 268 with MCC ....................................................................................
Proposed New MS–DRG 269 without MCC ...............................................................................
We are inviting public comments on
this proposal and the ICD–10–PCS code
translations for these procedures shown
earlier in this section, which we also are
proposing to assign to proposed new
MS–DRGs 268 and 269.
In addition, when we further applied
our established criteria to determine if
the creation of a new CC or MCC
subgroup for the remaining procedures
was warranted, we determined that a 3way severity level split (with MCC, with
CC, and without CC/MCC) was justified.
Therefore, we are proposing to create
three new MS–DRGs that would contain
the remaining cardiovascular
procedures that were designated as the
less complex, less invasive procedures,
as listed previously. For FY 2016, we
are proposing to create MS–DRG 270,
entitled ‘‘Other Major Cardiovascular
Procedures with MCC’’; MS–DRG 271,
entitled ‘‘Other Major Cardiovascular
Procedures with CC’’; and MS–DRG 272,
Average
length of stay
4,182
18,096
10.03
2.68
Average
costs
$45,996
28,431
entitled ‘‘Other Major Cardiovascular
Procedures without CC/MCC,’’ and to
assign the less complex, less invasive
cardiovascular procedures shown earlier
in this section to these proposed new
MS–DRGs. We believe that, as shown in
the table below, the distribution of cases
and average length of stay and average
costs of these procedures would be more
appropriately reflected when these
types of procedures are classified under
these proposed new MS–DRGs.
PROPOSED NEW MS–DRGS FOR OTHER MAJOR CARDIOVASCULAR PROCEDURES
Number
of cases
MS–DRG
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Proposed New MS–DRG 270 with MCC ....................................................................................
Proposed New MS–DRG 271 with CC .......................................................................................
Proposed New MS–DRG 272 without CC/MCC .........................................................................
We are inviting public comments on
this proposal and the ICD–10–PCS code
translations for the less complex, less
invasive cardiovascular procedures
shown earlier in this section, which we
also are proposing to assign to proposed
new MS–DRGs 270, 271, and 272.
In summary, for FY 2016, we are
proposing to delete MS–DRGs 237 and
238, and to create the following five
new MS–DRGs:
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• Proposed new MS–DRG 268 (Aortic
and Heart Assist Procedures Except
Pulsation Balloon with MCC);
• Proposed new MS–DRG 269 (Aortic
and Heart Assist Procedures Except
Pulsation Balloon without MCC);
• Proposed new MS–DRG 270 (Other
Major Cardiovascular Procedures with
MCC);
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14,158
9,648
4,483
Average
length of stay
9.3
5.99
3.08
Average
costs
$33,507
22,800
16,438
• Proposed new MS–DRG 271 (Other
Major Cardiovascular Procedures with
CC); and
• Proposed new MS–DRG 272 (Other
Major Cardiovascular Procedures
without CC/MCC).
We also are proposing to assign the
more complex, more invasive
cardiovascular procedures identified in
our analysis and the ICD–10–PCS code
translations to proposed new MS–DRGs
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Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
268 and 269. In addition, we are
proposing to assign the less complex,
less invasive cardiovascular procedures
identified in our analysis and the ICD–
10–PCS code translations to proposed
new MS–DRGs 270, 271, and 272. We
encourage public comments on our
proposal to create these proposed new
MS–DRGs, as well as the ICD–10–PCS
code translations that we are proposing
to assign to the corresponding proposed
new MS–DRGs.
4. MDC 8 (Diseases and Disorders of the
Musculoskeletal System and Connective
Tissue)
a. Revision of Hip or Knee
Replacements: Proposed Revision of
ICD–10–PCS Version 32 Logic
We received two comments that the
logic for ICD–10 MS–DRGs Version 32
does not work the same as it does for the
ICD–9–CM based MS–DRGs Version 32
for joint revisions. One of the
commenters requested that CMS change
the MS–DRG structure for joint
revisions within the ICD–10 MS–DRGs
466, 467, and 468 (Revision of Hip or
Knee Replacement with MCC, with CC,
and without CC/MCC, respectively) so
that cases that have a spacer removed
prior to the insertion of a new joint
prosthesis are assigned to MS–DRG 466,
467, and 468, as is the case with the
ICD–9–CM MS–DRGs. The other
commenter asked that joint revision
cases that involve knee revisions with
cemented and uncemented qualifiers be
assigned to these MS–DRGs. This
commenter provided an example of a
patient admitted for a knee revision and
reported under ICD–10–PCS codes
0SPD0JZ (Removal of synthetic
substitute from left knee joint, open
approach) and 0SRU0JA (Replacement
of left knee joint, femoral surface with
synthetic substitute, uncemented, open
approach), which should be assigned to
MS–DRGs 466, 467, and 468. The
requestor stated that revision cases
coded with ICD–9–CM codes are
assigned to MS–DRGs 466, 467, and
468, but similar cases reported with
these ICD–10–PCS codes are not
assigned to MS–DRGs 466, 467, and 468
in ICD–10–PCS MS–DRGs Version 32.
24379
We agree that joint revision cases with
the removal of a spacer and subsequent
insertion of a new joint prosthesis
should be assigned to MS–DRGs 466,
467, and 468 as is the case currently
with the ICD–9–CM based MS–DRGs
Version 32. We also agree that knee
revisions that involve cemented and
uncemented qualifiers should be
assigned to MS–DRGs 466, 467, and
468. Knee revision cases currently
reported with ICD–9–CM codes are
assigned to MS–DRGs 466, 467, and 468
in the ICD–9–CM based MS–DRGs. We
examined joint revision combination
codes that are not currently assigned to
MS–DRGs 466, 467, and 468 in ICD–10
MS–DRGs Version 32 and identified
additional combinations that also
should be included so that the joint
revision MS–DRGs would have the same
logic as the ICD–9–CM MS–DRGs. We
are proposing to add the following code
combinations which capture the joint
revisions to the Version 33 MS–DRG
structure for ICD–10 MS–DRGs 466,
467, and 468 that we are proposing to
implement effective October 1, 2015.
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS
ICD–10–PCS
code
0SP908Z ......
ICD–10–PCS
code
Code description
Replacement of right hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, open approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with synthetic substitute, cemented, open approach.
Replacement of right hip joint with synthetic substitute, uncemented, open approach.
Replacement of right hip joint with synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
spacer from right hip joint, open ap-
and
0SR9019 .....
spacer from right hip joint, open ap-
and
0SR901A .....
spacer from right hip joint, open ap-
and
0SR901Z .....
spacer from right hip joint, open ap-
and
0SR9029 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SR902A .....
0SP908Z ......
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
spacer from right hip joint, open ap-
and
0SR902Z .....
spacer from right hip joint, open ap-
and
0SR9039 .....
spacer from right hip joint, open ap-
and
0SR903A .....
spacer from right hip joint, open ap-
and
0SR903Z .....
spacer from right hip joint, open ap-
and
0SR9049 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SR904A .....
0SP908Z ......
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
spacer from right hip joint, open ap-
and
0SR904Z .....
spacer from right hip joint, open ap-
and
0SR90J9 .....
spacer from right hip joint, open ap-
and
0SR90JA .....
spacer from right hip joint, open ap-
and
0SR90JZ .....
spacer from right hip joint, open ap-
and
0SRA009 .....
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
VerDate Sep<11>2014
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Code description
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MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA00A ....
Removal of spacer from right hip joint, open approach.
and
0SRA00Z .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA019 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA01A ....
0SP908Z ......
and
0SRA01Z .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
Removal of spacer from right hip joint, open approach.
and
0SRA039 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA03A ....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA03Z .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA0J9 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRA0JA .....
0SP908Z ......
and
0SRA0JZ .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
Removal of spacer from right hip joint, open approach.
and
0SRR019 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRR01A ....
0SP908Z ......
and
0SRR01Z ....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
Removal of spacer from right hip joint, open approach.
and
0SRR039 .....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
and
0SRR03A ....
0SP908Z ......
Removal of spacer from right hip joint, open approach.
Removal of spacer from right hip joint, open approach.
Removal of spacer from right hip joint, open approach.
and
0SRR03Z ....
and
0SRR0J9 .....
and
0SRR0JA ....
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
spacer from right hip joint, open ap-
and
0SRR0JZ .....
spacer from right hip joint, open ap-
and
0SU909Z .....
spacer from right hip joint, open ap-
and
0SUA09Z .....
spacer from right hip joint, open ap-
and
0SUR09Z ....
liner from right hip joint, open ap-
and
0SR9019 .....
liner from right hip joint, open ap-
and
0SR901A .....
liner from right hip joint, open ap-
and
0SR901Z .....
liner from right hip joint, open ap-
and
0SR9029 .....
Replacement of right hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, cemented, pen approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
synthetic Substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic Substitute, uncemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, open approach.
Supplement right hip joint with liner, open approach.
Supplement right hip joint, acetabular surface with
liner, open approach.
Supplement right hip joint, femoral surface with
liner, open approach.
Replacement of right hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, open approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
0SP908Z ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP908Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
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24381
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SR902A .....
liner from right hip joint, open ap-
and
0SR902Z .....
liner from right hip joint, open ap-
and
0SR9039 .....
liner from right hip joint, open ap-
and
0SR903A .....
liner from right hip joint, open ap-
and
0SR903Z .....
liner from right hip joint, open ap-
and
0SR9049 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SR904A .....
0SP909Z ......
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
liner from right hip joint, open ap-
and
0SR904Z .....
liner from right hip joint, open ap-
and
0SR90J9 .....
liner from right hip joint, open ap-
and
0SR90JA .....
liner from right hip joint, open ap-
and
0SR90JZ .....
liner from right hip joint, open ap-
and
0SRA009 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA00A ....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA00Z .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA019 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA01A ....
0SP909Z ......
and
0SRA01Z .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
Removal of liner from right hip joint, open approach.
and
0SRA039 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA03A ....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA03Z .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA0J9 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRA0JA .....
0SP909Z ......
and
0SRA0JZ .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
Removal of liner from right hip joint, open approach.
and
0SRR019 .....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRR01A ....
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRR01Z ....
Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with synthetic substitute, cemented, open approach.
Replacement of right hip joint with synthetic substitute, uncemented, open approach.
Replacement of right hip joint with synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, open approach.
0SP909Z ......
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP909Z ......
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MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SP909Z ......
Removal of liner from right hip joint, open approach.
and
0SRR039 .....
Removal of liner from right hip joint, open approach.
and
0SRR03A ....
Removal of liner from right hip joint, open approach.
Removal of liner from right hip joint, open approach.
Removal of liner from right hip joint, open approach.
and
0SRR03Z ....
and
0SRR0J9 .....
and
0SRR0JA ....
Removal of liner from
proach.
Removal of liner from
proach.
Removal of liner from
proach.
Removal of liner from
proach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
right hip joint, open ap-
and
0SRR0JZ .....
right hip joint, open ap-
and
0SU909Z .....
right hip joint, open ap-
and
0SUA09Z .....
right hip joint, open ap-
and
0SUR09Z ....
device from right hip joint,
and
0SR9019 .....
device from right hip joint,
and
0SR901A .....
device from right hip joint,
and
0SR901Z .....
device from right hip joint,
and
0SR9029 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SR902A .....
0SP90BZ .....
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
device from right hip joint,
and
0SR902Z .....
device from right hip joint,
and
0SR9039 .....
device from right hip joint,
and
0SR903A .....
device from right hip joint,
and
0SR903Z .....
device from right hip joint,
and
0SR9049 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SR904A .....
0SP90BZ .....
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
device from right hip joint,
and
0SR904Z .....
device from right hip joint,
and
0SR90J9 .....
device from right hip joint,
and
0SR90JA .....
device from right hip joint,
and
0SR90JZ .....
device from right hip joint,
and
0SRA009 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA00A ....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA00Z .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA019 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA01A ....
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, open approach.
Supplement right hip joint with liner, open approach.
Supplement right hip joint, acetabular surface with
liner, open approach.
Supplement right hip joint, femoral surface with
liner, open approach.
Replacement of right hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, open approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with synthetic substitute, cemented, open approach.
Replacement of right hip joint with synthetic substitute, uncemented, open approach.
Replacement of right hip joint with synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP909Z ......
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP90BZ .....
VerDate Sep<11>2014
18:20 Apr 29, 2015
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E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24383
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SP90BZ .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA01Z .....
and
0SRA039 .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA03A ....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA03Z .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA0J9 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRA0JA .....
0SP90BZ .....
and
0SRA0JZ .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
Removal of resurfacing device from right hip joint,
open approach.
and
0SRR019 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRR01A ....
0SP90BZ .....
and
0SRR01Z ....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
Removal of resurfacing device from right hip joint,
open approach.
and
0SRR039 .....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
and
0SRR03A ....
0SP90BZ .....
Removal of resurfacing device from right hip joint,
open approach.
Removal of resurfacing device from right hip joint,
open approach.
Removal of resurfacing device from right hip joint,
open approach.
and
0SRR03Z ....
and
0SRR0J9 .....
and
0SRR0JA ....
Removal of resurfacing device from right
open approach.
Removal of resurfacing device from right
open approach.
Removal of resurfacing device from right
open approach.
Removal of resurfacing device from right
open approach.
Removal of synthetic substitute from right
open approach.
hip joint,
and
0SRR0JZ .....
hip joint,
and
0SU909Z .....
hip joint,
and
0SUA09Z .....
hip joint,
and
0SUR09Z ....
hip joint,
and
0SR9049 .....
0SP90JZ ......
Removal of synthetic substitute from right hip joint,
open approach.
and
0SR904A .....
0SP90JZ ......
Removal of synthetic substitute from right hip
open approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SR904Z .....
joint,
and
0SR9019 .....
joint,
and
0SR901A .....
joint,
and
0SR901Z .....
joint,
and
0SR9029 .....
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of right hip joint, acetabular Surface
with synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, open approach.
Supplement right hip joint with liner, open approach.
Supplement right hip joint, acetabular surface with
liner, open approach.
Supplement right hip joint, femoral surface with
liner, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, open approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach.
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90BZ .....
0SP90JZ ......
0SP948Z ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SR902A .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SR902Z .....
VerDate Sep<11>2014
18:20 Apr 29, 2015
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PO 00000
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E:\FR\FM\30APP2.SGM
30APP2
24384
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
0SP948Z ......
ICD–10–PCS
code
Code description
joint,
and
0SR9039 .....
hip
joint,
and
0SR903A .....
hip
joint,
and
0SR903Z .....
hip
joint,
and
0SR9049 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SR904A .....
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
hip
joint,
and
0SR904Z .....
hip
joint,
and
0SR90J9 .....
hip
joint,
and
0SR90JA .....
hip
joint,
and
0SR90JZ .....
hip
joint,
and
0SRA009 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA00A ....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA00Z .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA019 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA01A ....
0SP948Z ......
spacer from right hip
endoscopic approach.
spacer from right hip
endoscopic approach.
joint,
and
0SRA01Z .....
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
joint,
and
0SRA039 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA03A ....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA03Z .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA0J9 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRA0JA .....
0SP948Z ......
spacer from right hip
endoscopic approach.
spacer from right hip
endoscopic approach.
joint,
and
0SRA0JZ .....
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
joint,
and
0SRR019 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRR01A ....
0SP948Z ......
spacer from right hip
endoscopic approach.
spacer from right hip
endoscopic approach.
joint,
and
0SRR01Z ....
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
joint,
and
0SRR039 .....
0SP948Z ......
Removal of spacer from right hip
percutaneous endoscopic approach.
joint,
and
0SRR03A ....
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP948Z ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP948Z ......
VerDate Sep<11>2014
18:20 Apr 29, 2015
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with synthetic substitute, cemented, open approach.
Replacement of right hip joint with synthetic substitute, uncemented, open approach.
Replacement of right hip joint with synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of right hip joint, acetabular Surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
hip
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
Code description
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
spacer from right
endoscopic approach.
Jkt 235001
PO 00000
Frm 00062
Fmt 4701
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E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24385
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
0SP948Z ......
ICD–10–PCS
code
Code description
and
0SRR03Z ....
joint,
and
0SRR0J9 .....
joint,
and
0SRR0JA ....
joint,
and
0SRR0JZ .....
joint,
and
0SU909Z .....
joint,
and
0SUA09Z .....
joint,
and
0SUR09Z ....
joint,
and
0SR9019 .....
joint,
and
0SR901A .....
joint,
and
0SR901Z .....
joint,
and
0SR9029 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SR902A .....
0SP94JZ ......
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
hip joint,
and
0SR902Z .....
hip joint,
and
0SR9039 .....
hip joint,
and
0SR903A .....
hip joint,
and
0SR903Z .....
hip joint,
and
0SR9049 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SR904A .....
0SP94JZ ......
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
Removal of synthetic substitute from right
percutaneous endoscopic approach.
hip joint,
and
0SR904Z .....
hip joint,
and
0SR90J9 .....
hip joint,
and
0SR90JA .....
hip joint,
and
0SR90JZ .....
hip joint,
and
0SRA009 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA00A ....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA00Z .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA019 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA01A ....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA01Z .....
and
0SRA039 .....
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP948Z ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SP94JZ ......
0SP94JZ ......
VerDate Sep<11>2014
spacer from right hip
endoscopic approach.
spacer from right hip
endoscopic approach.
spacer from right hip
endoscopic approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, open approach.
Supplement right hip joint with liner, open approach.
Supplement right hip joint, acetabular surface with
liner, open approach.
Supplement right hip joint, femoral surface with
liner, open approach.
Replacement of right hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of right hip joint with metal synthetic
substitute, open approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of right hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with ceramic synthetic substitute, cemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, uncemented, open approach.
Replacement of right hip joint with ceramic synthetic substitute, open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, uncemented,
open approach.
Replacement of right hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of right hip joint with synthetic substitute, cemented, open approach.
Replacement of right hip joint with synthetic substitute, uncemented, open approach.
Replacement of right hip joint with synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of right hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of right hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
joint,
0SP948Z ......
Removal of
percutaneous
Removal of
percutaneous
Removal of
percutaneous
Code description
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of spacer from right hip
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip
percutaneous endoscopic approach.
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00063
Fmt 4701
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E:\FR\FM\30APP2.SGM
30APP2
24386
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA03A ....
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA03Z .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA0J9 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRA0JA .....
0SP94JZ ......
and
0SRA0JZ .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRR019 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRR01A ....
0SP94JZ ......
and
0SRR01Z ....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRR039 .....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRR03A ....
0SP94JZ ......
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
and
0SRR03Z ....
and
0SRR0J9 .....
and
0SRR0JA ....
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from right hip joint,
percutaneous endoscopic approach.
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRR0JZ .....
and
0SU909Z .....
and
0SUA09Z .....
and
0SUR09Z ....
and
0SRB019 .....
and
0SRB01A ....
and
0SRB01Z .....
and
0SRB029 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRB02A ....
0SPB08Z .....
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
spacer from left hip joint, open ap-
and
0SRB02Z .....
spacer from left hip joint, open ap-
and
0SRB039 .....
spacer from left hip joint, open ap-
and
0SRB03A ....
spacer from left hip joint, open ap-
and
0SRB03Z .....
spacer from left hip joint, open ap-
and
0SRB049 .....
Removal of spacer from left hip joint, open approach.
and
0SRB04A ....
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of right hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of right hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of right hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of right hip joint, femoral surface with
synthetic substitute, open approach.
Supplement right hip joint with liner, open approach.
Supplement right hip joint, acetabular surface with
liner, open approach.
Supplement right hip joint, femoral surface with
liner, open approach.
Replacement of left hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, open approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, cemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SP94JZ ......
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00064
Fmt 4701
Sfmt 4702
E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24387
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
0SPB08Z .....
ICD–10–PCS
code
Code description
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with synthetic substitute, cemented, open approach.
Replacement of left hip joint with synthetic substitute, uncemented, open approach.
Replacement of left hip joint with synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, open approach.
Supplement left hip joint with liner, open approach.
spacer from left hip joint, open ap-
and
0SRB04Z .....
spacer from left hip joint, open ap-
and
0SRB0J9 .....
spacer from left hip joint, open ap-
and
0SRB0JA .....
spacer from left hip joint, open ap-
and
0SRB0JZ .....
spacer from left hip joint, open ap-
and
0SRE009 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE00A ....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE00Z .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE019 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE01A ....
0SPB08Z .....
and
0SRE01Z .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRE039 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE03A ....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE03Z .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE0J9 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRE0JA .....
0SPB08Z .....
and
0SRE0JZ .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRS019 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRS01A ....
0SPB08Z .....
and
0SRS01Z .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRS039 .....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
and
0SRS03A ....
0SPB08Z .....
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRS03Z .....
and
0SRS0J9 .....
and
0SRS0JA .....
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
Removal of spacer from left hip joint, open approach.
and
0SRS0JZ .....
and
0SUB09Z .....
and
0SUE09Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
0SPB08Z .....
VerDate Sep<11>2014
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
Code description
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00065
Fmt 4701
Sfmt 4702
Supplement left hip joint, acetabular surface with
liner, open approach.
E:\FR\FM\30APP2.SGM
30APP2
24388
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
Code description
0SPB08Z .....
0SPB09Z .....
Removal of spacer from left hip joint, open approach.
Removal of liner from left hip joint, open approach
0SPB09Z .....
ICD–10–PCS
code
Code description
and
0SUS09Z .....
and
0SRB019 .....
Removal of liner from left hip joint, open approach
and
0SRB01A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB01Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB029 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB02A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB02Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB039 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB03A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB03Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB049 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB04A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB04Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB0J9 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB0JA .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRB0JZ .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE009 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE00A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE00Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE019 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE01A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE01Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE039 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE03A ....
0SPB09Z .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS
code
Removal of liner from left hip joint, open approach
and
0SRE03Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE0J9 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE0JA .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRE0JZ .....
Supplement left hip joint, femoral surface with
liner, open approach.
Replacement of left hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, open approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, cemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with synthetic substitute, cemented, open approach.
Replacement of left hip joint with synthetic substitute, uncemented, open approach.
Replacement of left hip joint with synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, open approach.
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00066
Fmt 4701
Sfmt 4702
E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24389
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS019 .....
Removal of liner from left hip joint, open approach
and
0SRS01A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS01Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS039 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS03A ....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS03Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS0J9 .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS0JA .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SRS0JZ .....
0SPB09Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
Removal of liner from left hip joint, open approach
and
and
0SUB09Z .....
0SUE09Z .....
0SPB09Z .....
Removal of liner from left hip joint, open approach
and
0SUS09Z .....
0SPB0BZ .....
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
device from left hip joint,
and
0SRB019 .....
device from left hip joint,
and
0SRB01A ....
device from left hip joint,
and
0SRB01Z .....
device from left hip joint,
and
0SRB029 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRB02A ....
0SPB0BZ .....
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
device from left hip joint,
and
0SRB02Z .....
device from left hip joint,
and
0SRB039 .....
device from left hip joint,
and
0SRB03A ....
device from left hip joint,
and
0SRB03Z .....
device from left hip joint,
and
0SRB049 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRB04A ....
0SPB0BZ .....
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
Removal of resurfacing
open approach.
device from left hip joint,
and
0SRB04Z .....
device from left hip joint,
and
0SRB0J9 .....
device from left hip joint,
and
0SRB0JA .....
device from left hip joint,
and
0SRB0JZ .....
device from left hip joint,
and
0SRE009 .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE00A ....
Replacement of left hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, open approach.
Supplement left hip joint with liner, open approach.
Supplement left hip joint, acetabular surface with
liner, open approach.
Supplement left hip joint, femoral surface with
liner, open approach.
Replacement of left hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, open approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, cemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with synthetic substitute, cemented, open approach.
Replacement of left hip joint with synthetic substitute, uncemented, open approach.
Replacement of left hip joint with synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
0SPB09Z .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00067
Fmt 4701
Sfmt 4702
E:\FR\FM\30APP2.SGM
30APP2
24390
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE00Z .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE019 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE01A ....
0SPB0BZ .....
and
0SRE01Z .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE039 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE03A ....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE03Z .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE0J9 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRE0JA .....
0SPB0BZ .....
and
0SRE0JZ .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
Removal of resurfacing device from left hip joint,
open approach.
and
0SRS019 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRS01A ....
0SPB0BZ .....
and
0SRS01Z .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
Removal of resurfacing device from left hip joint,
open approach.
and
0SRS039 .....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
and
0SRS03A ....
0SPB0BZ .....
Removal of resurfacing device from left hip joint,
open approach.
Removal of resurfacing device from left hip joint,
open approach.
Removal of resurfacing device from left hip joint,
open approach.
and
0SRS03Z .....
and
0SRS0J9 .....
and
0SRS0JA .....
Removal of resurfacing device from
open approach.
Removal of resurfacing device from
open approach.
Removal of resurfacing device from
open approach.
Removal of resurfacing device from
open approach.
Removal of synthetic substitute from
open approach.
left hip joint,
and
0SRS0JZ .....
left hip joint,
and
0SUB09Z .....
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, open approach.
Supplement left hip joint with liner, open approach.
0SPB0BZ .....
left hip joint,
and
0SUE09Z .....
left hip joint,
and
0SUS09Z .....
left hip joint,
and
0SRB049 .....
0SPB0JZ ......
Removal of synthetic substitute from left hip joint,
open approach.
and
0SRB04A ....
0SPB0JZ ......
Removal of synthetic substitute from left hip joint,
open approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRB04Z .....
and
0SRB019 .....
and
0SRB01A ....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
0SPB0BZ .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB0JZ ......
0SPB48Z .....
0SPB48Z .....
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
PO 00000
Frm 00068
Fmt 4701
Sfmt 4702
Supplement left hip joint, acetabular surface with
liner, open approach.
Supplement left hip joint, femoral surface with
liner, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, uncemented, open approach.
E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24391
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SPB48Z .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRB01Z .....
and
0SRB029 .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRB02A ....
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
hip joint, percutaneous
and
0SRB02Z .....
hip joint, percutaneous
and
0SRB039 .....
hip joint, percutaneous
and
0SRB03A ....
hip joint, percutaneous
and
0SRB03Z .....
hip joint, percutaneous
and
0SRB049 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRB04A ....
0SPB48Z .....
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
Removal of spacer from left
endoscopic approach.
hip joint, percutaneous
and
0SRB04Z .....
hip joint, percutaneous
and
0SRB0J9 .....
hip joint, percutaneous
and
0SRB0JA .....
hip joint, percutaneous
and
0SRB0JZ .....
hip joint, percutaneous
and
0SRE009 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE00A ....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE00Z .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE019 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE01A ....
0SPB48Z .....
and
0SRE01Z .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE039 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE03A ....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE03Z .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE0J9 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE0JA .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRE0JZ .....
and
0SRS019 .....
Replacement of left hip joint with metal synthetic
substitute, open approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, cemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with synthetic substitute, cemented, open approach.
Replacement of left hip joint with synthetic substitute, uncemented, open approach.
Replacement of left hip joint with synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB48Z .....
0SPB48Z .....
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E:\FR\FM\30APP2.SGM
30APP2
24392
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRS01A ....
and
0SRS01Z .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRS039 .....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRS03A ....
0SPB48Z .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
and
0SRS03Z .....
and
0SRS0J9 .....
and
0SRS0JA .....
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of spacer from left hip joint, percutaneous
endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS0JZ .....
and
0SUB09Z .....
Replacement of left hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, open approach.
Supplement left hip joint with liner, open approach.
0SPB48Z .....
and
0SUE09Z .....
and
0SUS09Z .....
and
0SRB019 .....
and
0SRB01A ....
and
0SRB01Z .....
and
0SRB029 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRB02A ....
0SPB4JZ ......
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
hip joint,
and
0SRB02Z .....
hip joint,
and
0SRB039 .....
hip joint,
and
0SRB03A ....
hip joint,
and
0SRB03Z .....
hip joint,
and
0SRB049 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRB04A ....
0SPB4JZ ......
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
hip joint,
and
0SRB04Z .....
hip joint,
and
0SRB0J9 .....
hip joint,
and
0SRB0JA .....
hip joint,
and
0SRB0JZ .....
hip joint,
and
0SRE009 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE00A ....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE00Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB48Z .....
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPB4JZ ......
0SPB4JZ ......
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18:20 Apr 29, 2015
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Supplement left hip joint, acetabular surface with
liner, open approach.
Supplement left hip joint, femoral surface with
liner, open approach.
Replacement of left hip joint with metal synthetic
substitute, cemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with metal synthetic
substitute, open approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with metal on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, cemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, uncemented, open approach.
Replacement of left hip joint with ceramic synthetic
substitute, open approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, cemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, uncemented, open
approach.
Replacement of left hip joint with ceramic on polyethylene synthetic substitute, open approach.
Replacement of left hip joint with synthetic substitute, cemented, open approach.
Replacement of left hip joint with synthetic substitute, uncemented, open approach.
Replacement of left hip joint with synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with
polyethylene
synthetic
substitute,
uncemented, open approach.
Replacement of left hip joint, acetabular surface
with polyethylene synthetic substitute, open approach.
E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24393
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW HIP REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
Code description
ICD–10–PCS
code
Code description
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE019 .....
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE01A ....
and
0SRE01Z .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE039 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE03A ....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE03Z .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE0J9 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRE0JA .....
0SPB4JZ ......
and
0SRE0JZ .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS019 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS01A ....
0SPB4JZ ......
and
0SRS01Z .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS039 .....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS03A ....
0SPB4JZ ......
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
Removal of synthetic substitute from left hip joint,
percutaneous endoscopic approach.
and
0SRS03Z .....
and
0SRS0J9 .....
and
0SRS0JA .....
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
Removal of synthetic substitute from left
percutaneous endoscopic approach.
hip joint,
and
0SRS0JZ .....
hip joint,
and
0SUB09Z .....
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, cemented, open
approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with metal synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, cemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, uncemented,
open approach.
Replacement of left hip joint, acetabular surface
with ceramic synthetic substitute, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, cemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, uncemented, open approach.
Replacement of left hip joint, acetabular surface
with synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
metal synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, cemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, uncemented, open
approach.
Replacement of left hip joint, femoral surface with
ceramic synthetic substitute, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, cemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, uncemented, open approach.
Replacement of left hip joint, femoral surface with
synthetic substitute, open approach.
Supplement left hip joint with liner, open approach.
0SPB4JZ ......
0SPB4JZ ......
hip joint,
and
0SUE09Z .....
hip joint,
and
0SUS09Z .....
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
0SPB4JZ ......
Supplement left hip joint, acetabular surface with
liner, open approach.
Supplement left hip joint, femoral surface with
liner, open approach
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS
ICD–10–PCS
code
0SPC09Z
0SPC09Z
0SPC09Z
VerDate Sep<11>2014
ICD–10–PCS
code
Code description
and
0SRC0J9 .....
and
0SRC0JA ....
and
0SRC0JZ .....
Replacement of right knee joint with synthetic substitute, cemented, open approach.
Replacement of right knee joint with synthetic substitute, uncemented, open approach.
Replacement of right knee joint with synthetic substitute, open approach.
Code descriptions
Removal of liner from right knee joint, open approach.
Removal of liner from right knee joint, open approach.
Removal of liner from right knee joint, open approach.
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30APP2
24394
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
ICD–10–PCS
code
Code descriptions
Code description
Replacement of right knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of right knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of right knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
Replacement of left knee joint with synthetic substitute, cemented, open approach.
Replacement of left knee joint with synthetic substitute, uncemented, open approach.
Replacement of left knee joint with synthetic substitute, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
0SPC09Z
Removal of liner from right knee joint, open approach.
and
0SRT0J9 .....
0SPC09Z
Removal of liner from right knee joint, open approach.
and
0SRT0JA .....
0SPC09Z
Removal of liner from right knee joint, open approach.
Removal of liner from right knee joint, open approach.
Removal of liner from right knee joint, open approach.
and
0SRT0JZ .....
and
0SRV0J9 .....
and
0SRV0JA .....
and
0SRV0JZ .....
0SPC0JZ
Removal of liner from right knee joint, open approach.
Removal of synthetic substitute from right knee
joint, open approach.
and
0SRT0J9 .....
0SPC0JZ
Removal of synthetic substitute from right knee
joint, open approach.
and
0SRT0JA .....
0SPC0JZ
synthetic substitute from right knee
approach.
synthetic substitute from right knee
approach.
and
0SRV0J9 .....
0SPC0JZ
Removal of
joint, open
Removal of
joint, open
and
0SRV0JA .....
0SPC4JZ
Removal of synthetic substitute from right knee
joint, percutaneous endoscopic approach.
and
0SRT0J9 .....
0SPC4JZ
Removal of synthetic substitute from right knee
joint, percutaneous endoscopic approach.
and
0SRT0JA .....
0SPC4JZ
Removal of synthetic substitute
joint, percutaneous endoscopic
Removal of synthetic substitute
joint, percutaneous endoscopic
from right knee
approach.
from right knee
approach.
and
0SRV0J9 .....
and
0SRV0JA .....
liner from left knee joint, open ap-
and
0SRD0J9 .....
liner from left knee joint, open ap-
and
0SRD0JA ....
liner from left knee joint, open ap-
and
0SRD0JZ .....
liner from left knee joint, open ap-
and
0SRU0J9 .....
0SPD09Z
Removal of liner from left knee joint, open approach.
and
0SRU0JA ....
0SPD09Z
Removal of liner from left knee joint, open approach.
Removal of liner from left knee joint, open approach.
Removal of liner from left knee joint, open approach.
and
0SRU0JZ .....
and
0SRW0J9 ....
and
0SRW0JA ....
and
0SRW0JZ ....
0SPD0JZ
Removal of liner from left knee joint, open approach.
Removal of synthetic substitute from left knee
joint, open approach.
and
0SRU0J9 .....
0SPD0JZ
Removal of synthetic substitute from left knee
joint, open approach.
and
0SRU0JA ....
0SPD0JZ
Removal of
joint, open
Removal of
joint, open
and
0SRW0J9 ....
and
0SRW0JA ....
0SPC09Z
0SPC09Z
0SPC09Z
0SPC4JZ
0SPD09Z
0SPD09Z
0SPD09Z
0SPD09Z
0SPD09Z
0SPD09Z
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0SPD09Z
0SPD0JZ
VerDate Sep<11>2014
Removal of
proach.
Removal of
proach.
Removal of
proach.
Removal of
proach.
synthetic substitute from left knee
approach.
synthetic substitute from left knee
approach.
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E:\FR\FM\30APP2.SGM
30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
24395
MS–DRG 466–468 ICD–10–PCS CODE PAIRS TO BE ADDED TO THE VERSION 33 ICD–10 MS–DRGS 466, 467, AND
468: PROPOSED NEW KNEE REVISION ICD–10–PCS COMBINATIONS—Continued
ICD–10–PCS
code
0SPD0JZ
ICD–10–PCS
code
Code descriptions
Code description
Replacement of left knee joint, tibial surface with
synthetic substitute, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, cemented, open approach.
Replacement of left knee joint, femoral surface
with synthetic substitute, uncemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, cemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, uncemented, open approach.
Replacement of left knee joint, tibial surface with
synthetic substitute, open approach.
and
0SRW0JZ ....
0SPD4JZ
Removal of synthetic substitute from left knee
joint, open approach.
Removal of synthetic substitute from left knee
joint, percutaneous endoscopic approach.
and
0SRU0J9 .....
0SPD4JZ
Removal of synthetic substitute from left knee
joint, percutaneous endoscopic approach.
and
0SRU0JA ....
0SPD4JZ
and
0SRW0J9 ....
0SPD4JZ
Removal of synthetic substitute from left knee
joint, percutaneous endoscopic approach.
Removal of synthetic substitute from left knee
joint, percutaneous endoscopic approach.
and
0SRW0JA ....
0SPD4JZ
Removal of synthetic substitute from left knee
joint, percutaneous endoscopic approach.
and
0SRW0JZ ....
We are inviting public comments on
our proposal to add the joint revision
code combinations listed above to MS–
DRGs 466, 467, and 468.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Spinal Fusion
We received a request to revise the
titles of MS–DRGs 456, 457, and 458
(Spinal Fusion Except Cervical with
Spinal Curvature/Malignancy/Infection
or 9+ Fusion with MCC, with CC, and
without CC/MCC, respectively) for the
ICD–10 MS–DRGs so that they more
closely correspond to the terminology
used to describe the ICD–10–PCS
procedure codes without changing the
ICD–10 MS–DRG logic. We agree with
the requestor that revising the titles of
these MS–DRGs would more
appropriately identify the procedures
classified under these groupings.
Therefore, we are proposing new titles
for these three MS–DRGs that would
change the reference of ‘‘9+ Fusions’’ to
‘‘Extensive Fusions.’’ The proposed title
revisions to MS–DRGs 456, 457, and 458
for the FY 2016 ICD–10 MS–DRGs
Version 33 are as follows:
• MS–DRG 456 (Spinal Fusion Except
Cervical with Spinal Curvature/
Malignancy/Infection or Extensive
Fusion with MCC)
• MS–DRG 457 (Spinal Fusion Except
Cervical with Spinal Curvature/
Malignancy/Infection or Extensive
Fusion with CC)
• MS–DRG 458 (Spinal Fusion Except
Cervical with Spinal Curvature/
Malignancy/Infection or Extensive
Fusion without CC/MCC).
We are inviting public comments on
our proposal.
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5. MDC 14 (Pregnancy, Childbirth and
the Puerperium): MS–DRG 775 (Vaginal
Delivery Without Complicating
Diagnosis)
We received a request to modify the
logic for ICD–10 MS–DRG 775 (Vaginal
Delivery without Complicating
Diagnosis) so that the procedure code
for the induction of labor with a cervical
ripening gel would not group to the
incorrect MS–DRG when a normal
delivery has occurred. ICD–10–PCS
code 3E0P7GC (Introduction of other
therapeutic substance into female
reproductive, via natural or artificial
opening) describes this procedure.
We reviewed how this code is
currently classified under the ICD–10
MS–DRGs Version 32 and noted that it
is currently designated as an operating
room (O.R.) code affecting MS–DRG
assignment. We agree with the requestor
that the current logic for ICD–10–PCS
procedure code 3E0P7GC does not
result in the appropriate MS–DRG
assignment. The result of our analysis
suggests that this code should not be
designated as an O.R. code. Our clinical
advisors agree that this procedure does
not require the intensity or complexity
of service and resource utilization to
merit an O.R. designation under ICD–10.
Therefore, we are proposing to make
ICD–10–PCS procedure code 3E0P7GC a
non-O.R. code so that cases reporting
this procedure code will group to the
appropriate MS–DRG assignment. We
are inviting public comments on our
proposal.
Our analysis of ICD–10–PCS code
3E0P7GC also prompted the review of
additional, similar codes that describe
the introduction of a substance. We
evaluated the following ICD–10–PCS
procedure codes:
• 3E0P76Z (Introduction of
nutritional substance into female
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reproductive, via natural or artificial
opening);
• 3E0P77Z (Introduction of
electrolytic and water balance substance
into female reproductive, via natural or
artificial opening);
• 3E0P7SF (Introduction of other gas
into female reproductive, via natural or
artificial opening);
• 3E0P83Z (Introduction of antiinflammatory into female reproductive,
via natural or artificial opening
endoscopic);
• 3E0P86Z (Introduction of
nutritional substance into female
reproductive, via natural or artificial
opening endoscopic);
• 3E0P87Z (Introduction of
electrolytic and water balance substance
into female reproductive, via natural or
artificial opening endoscopic);
• 3E0P8GC (Introduction of other
therapeutic substance into female
reproductive, via natural or artificial
opening endoscopic); and
• 3E0P8SF (Introduction of other gas
into female reproductive, via natural or
artificial opening endoscopic).
From our analysis, we determined
that these codes also are currently
designated as O.R. codes affecting MS–
DRG assignment. Our clinical advisors
recommended that these codes should
also be designated as non-O.R. because
they do not require the intensity or
complexity of service and resource
utilization to merit an O.R. designation
under the ICD–10 MS–DRGs. As a result
of our analysis and our clinical advisors’
recommendation, we are proposing to
designate the above listed ICD–10–PCS
procedure codes as non-O.R. codes to
ensure that these codes will group to the
appropriate MS–DRG assignment.
We are inviting public comments on
our proposal.
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6. MDC 21 (Injuries, Poisonings and
Toxic Effects of Drugs): CroFab
Antivenin Drug
We received a request that CMS
change the MS–DRG assignment for
antivenom cases from MS–DRG 917 and
918 (Poisoning & Toxic Effects of Drugs
with and without MCC, respectively).
For these MS–DRGs, we examined
claims data from the December 2014
update of the FY 2014 MedPAR file for
ICD–9–CM diagnosis codes of a
principal diagnosis 989.5 (Toxic effect
of venom), a secondary diagnosis ICD–
9–CM E code of E905.0 (Venomous
snakes and lizards), and the ICD–9–CM
procedure code of 99.16 (Injection of
antidote), which is a non-O.R. code and
does not impact the MS–DRG
assignment.
For the ICD–9–CM diagnosis code
989.5 (Toxic effect of venom), the ICD–
10–CM provides more detailed
diagnosis codes for these toxic effects of
venom cases as shown in the following
table:
ICD–10–CM CODE TRANSLATIONS FOR ICD–9–CM DIAGNOSIS CODE 989.5
ICD–10–CM code
T63.001A ......................
T63.011A ......................
T63.021A ......................
T63.031A ......................
T63.041A ......................
T63.061A ......................
T63.71A ........................
T63.081A ......................
T63.091A ......................
Code description
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
effect
effect
effect
effect
effect
effect
effect
effect
effect
of
of
of
of
of
of
of
of
of
unspecified snake venom, accidental (unintentional), initial encounter.
rattlesnake venom, accidental (unintentional) initial encounter.
coral snake venom, accidental (unintentional), initial encounter.
taipan venom, accidental (unintentional), initial encounter.
cobra venom, accidental (unintentional), initial encounter.
venom of other North and South American snake, accidental (unintentional), initial encounter.
venom of other Australian snake, accidental (unintentional), initial encounter.
venom of other African and Asian snake, accidental (unintentional), initial encounter.
venom of other snake, accidental (unintentional), initial encounter.
For the ICD–9–CM Supplementary
Classification of External Causes of
Injury and Poisoning code E905.0
(Venomous snakes and lizards), ICD–
10–CM provides more detailed
diagnosis codes for these cases as shown
in the following table:
ICD–10–CM CODE TRANSLATIONS FOR ICD–9–CM CODE E905.0
ICD–10–CM code
T63.001A ......................
T63.011A ......................
T63.021A ......................
T63.031A ......................
T63.041A ......................
T63.061A ......................
T63.71A ........................
T63.081A ......................
T63.091A ......................
Code description
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
Toxic
effect
effect
effect
effect
effect
effect
effect
effect
effect
of
of
of
of
of
of
of
of
of
unspecified snake venom, accidental (unintentional), initial encounter.
rattlesnake venom, accidental (unintentional) initial encounter.
coral snake venom, accidental (unintentional), initial encounter.
taipan venom, accidental (unintentional), initial encounter.
cobra venom, accidental (unintentional), initial encounter.
venom of other North and South American snake, accidental (unintentional), initial encounter.
venom of other Australian snake, accidental (unintentional), initial encounter.
venom of other African and Asian snake, accidental (unintentional), initial encounter.
venom of other snake, accidental (unintentional), initial encounter.
We examined claims data for
injections for snake bites reported in
MS–DRGs 917 and 918 from the
December 2014 update of the FY 2014
MedPAR file. Our findings are
displayed in the table below.
SNAKE BITE WITH INJECTIONS
Number of
cases
MS–DRG
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 917—All cases ............................................................................................................
MS–DRG 917—Cases with principal diagnosis code 989.5 and secondary diagnosis code
E905.0 with procedure code 99.16 (non-OR) ..........................................................................
MS–DRG 918—All cases ............................................................................................................
MS–DRG 918—Cases with principal diagnosis code 989.5 and secondary diagnosis code
E905.0 with procedure code 99.16 (non-OR) ..........................................................................
As shown in the table above, we
identified 19 cases of injections for
snake bites reported in MS–DRG 918
only. This small number of cases (19)
does not provide justification to create
a new MS–DRG. The cases are assigned
to the same MS–DRG as are other types
of poisonings and toxic effects. We were
unable to find another MS–DRG that
would be a more appropriate MS–DRG
assignment for these cases based on the
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clinical nature of this condition. The
MS–DRGs are a classification system
intended to group together diagnoses
and procedures with similar clinical
characteristics and utilization of
resources. Basing a new MS–DRG on
such a small number of cases (19) could
lead to distortions in the relative
payment weights for the MS–DRG
because several expensive cases could
impact the overall relative payment
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Average
length of stay
Average
costs
26,393
4.77
$9,983
0
24,557
0
2.90
0
4,953
19
2.16
12,014
weight. Having larger clinical cohesive
groups within an MS–DRG provides
greater stability for annual updates to
the relative payment weights.
Our clinical advisors reviewed the
data, evaluated these conditions, and
recommended that we not change the
MS–DRG assignment for CroFab
antivenom drug for snake bites because
these cases are clinically similar to other
poisoning cases currently assigned to
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MS–DRGs 917 and 918. Based on the
findings in our data analysis and the
recommendations of our clinical
advisors, we are proposing to maintain
the current assignment of diagnosis
codes in MS–DRGs 917 and 918. We are
not proposing any MS–DRG changes for
cases of CroFab antivenom drugs for
snake bites. We are inviting public
comments on our proposal.
7. MDC 22 (Burns): Additional Severity
of Illness Level for MS–DRG 927
(Extensive Burns or Full Thickness
Burns With Mechanical Ventilation 96+
Hours With Skin Graft)
We received a request to add an
additional severity level to MS–DRG
927 (Extensive Burns or Full Thickness
Burns with Mechanical Ventilation 96+
Hours with Skin Graft). The requestor
was concerned about payment for severe
burn cases that used dermal
regenerative grafts. These grafts are
captured by procedure code 86.67
(Dermal regenerative graft). The
requestor stated that the total cost of
these graft cases is significantly greater
than the average total costs for all cases
in MS–DRG 927. The requestor stated
that the dermal regenerative grafts are
used to cover large burns where donor
skin is not available. The requestor
stated that the grafts provide permanent
covering of the wound and thus
immediate closure of the wound. The
requestor asserted that the grafts offer
benefits such as the avoidance of
infections. The requestor pointed out
that MS–DRG 927 is not subdivided into
severity of illness levels and
recommended an additional severity
level be added to address any payment
issues for dermal regenerative grafts
within MS–DRG 927.
ICD–10–PCS provides more detailed
and specific codes for skin grafts. The
ICD–10–PCS codes for skin grafts
provide specific information on the part
of the body receiving the skin graft, the
type of graft, and the approach used to
apply the graft. These codes can be
found in the table labeled ‘‘OHR
(Replacement of Skin)’’ in the ICD–10
MS–DRG Version 32 Definitions Manual
available on the Internet at: https://
www.cms.gov/Medicare/Coding/ICD10/
ICD-10-MS-DRG-ConversionProject.html. As stated earlier, for the
ICD–9–CM codes that result in greater
than 50 ICD–10–PCS comparable code
translations, we refer readers to Table
6P (ICD–10–PCS Code Translations for
Proposed MS–DRG Changes), which is
available via the Internet on the CMS
Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html. The table includes the MDC
topic, the ICD–9–CM code, and the ICD–
10–PCS code translations. In Table
6P.2a, we show the comparable ICD–10–
PCS codes for ICD–9–CM code 86.67
(Dermal regenerative graft).
We examined claims data for cases
reported in MS–DRG 927 from the
December 2014 update of the FY 2014
MedPAR file. The following table shows
our findings.
EXTENSIVE BURNS OR FULL THICKNESS BURNS WITH MECHANICAL VENTILATION 96+ HOURS WITH SKIN GRAFT
Number of
cases
MS–DRG
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 927—All cases ............................................................................................................
MS–DRG 927—Cases with procedure code 86.67 ....................................................................
MS–DRG 927—Cases with procedure code 86.67 and 96.72 (Mechanical ventilation for 96+
hours) .......................................................................................................................................
MS–DRG 927—Cases with procedure code 86.67 and without 96.72 (Mechanical ventilation
for 96+ hours) ...........................................................................................................................
MS–DRG 927—All cases with MCC ...........................................................................................
MS–DRG 927—All cases with CC ..............................................................................................
MS–DRG 927—All cases without CC/MCC ................................................................................
As shown in the table above, we
found a total of 171 cases in MS–DRG
927. Of these 171 cases, there were 131
cases with an MCC, 38 cases with a CC,
and 2 cases without a CC or an MCC.
The requested new severity level does
not meet all of the criteria established in
the FY 2008 IPPS final rule (72 FR
47169), and described in section
II.G.1.b. of the preamble of this
proposed rule, that must be met to
warrant the creation of a CC or an MCC
subgroup within a base MS–DRG.
Specifically, the requested new severity
level does not meet the criterion that
there are at least 500 cases in the CC or
MCC subgroup.
We also point out that the long-term
mechanical ventilation cases are driving
the costs to a greater extent than the
graft cases. We found that the 22 cases
that received a graft had average costs of
$146,903. The 14 cases that had both
96+ hours of mechanical ventilation and
a graft had average costs of $174,372.
The 8 cases that had a graft but did not
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receive 96+ hours of mechanical
ventilation had average costs of $98,482.
Our clinical advisors reviewed this
issue and recommended making no MS–
DRG updates for MS–DRG 927. They
advised us that the dermal regenerative
graft cases are appropriately assigned to
the MS–DRG 927 because they are
clinically similar to other cases within
MS–DRG 927. Our clinical advisors also
agreed that the cases in MS–DRG 927 do
not meet the established criterion for
creating a new severity level.
Based on the findings of our data
analysis, the fact that MS–DRG 927 does
not meet the criterion for the creation of
an additional severity level, and the
recommendations of our clinical
advisors, we are not proposing to create
a new severity level for MS–DRG 927.
We are proposing to maintain the
current MS–DRG 927 structure without
additional severity levels. We are
inviting public comments on our
proposal.
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Average
length of stay
Average
costs
171
22
29.92
33.5
$113,844
146,903
14
38.6
174,372
8
131
38
2
24.6
31.51
25.21
15.00
98,482
121,519
91,910
27,872
8. Proposed Medicare Code Editor
(MCE) Changes
The Medicare Code Editor (MCE) is a
software program that detects and
reports errors in the coding of Medicare
claims data. Patient diagnoses,
procedure(s), and demographic
information are entered into the
Medicare claims processing systems and
are subjected to a series of automated
screens. The MCE screens are designed
to identify cases that require further
review before classification into an MS–
DRG.
As discussed in section II.G.1.a. of the
preamble of this proposed rule, CMS
prepared the ICD–10 MS–DRGs Version
32 based on the FY 2015 MS–DRGs
(Version 32) that we finalized in the FY
2015 IPPS/LTCH PPS final rule. In
November 2014, we made available a
Definitions Manual of the ICD–10 MS–
DRGs Version 32 and the MCE Version
32 on the ICD–10 MS–DRG Conversion
Project Web site at: https://www.cms.gov/
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Medicare/Coding/ICD10/ICD-10-MSDRG-Conversion-Project.html. We also
prepared a document that described the
changes made between Version 31–R to
Version 32 to help facilitate a review of
the ICD–10 MS–DRGs logic. We
produced mainframe and computer
software for ICD–10 MS–DRGs Version
32 and MCE Version 32, which was
made available to the public in January
2015. Information on ordering the
mainframe and computer software
through NTIS was made available on the
CMS Web site at: https://www.cms.gov/
Medicare/Coding/ICD10/ICD-10-MSDRG-Conversion-Project.html under the
‘‘Related Links’’ section. We encouraged
the public to submit to CMS any
comments on areas where they believed
the ICD–10 MS–DRG GROUPER and
MCE did not accurately reflect the logic
and edits found in the ICD–9–CM MS–
DRG GROUPER and the MCE.
For FY 2016, in order to be consistent
with the ICD–9–CM MS–DRG
GROUPER and MCE Version 32, we are
proposing to add the ICD–10–PCS codes
listed in the table below to the ICD–10
MCE Version 33 of the ‘‘Manifestation
codes not allowed as principal
diagnosis’’ edit. Under the MCE,
manifestation codes describe the
‘‘manifestation’’ of an underlying
disease, not the disease itself. Because
these codes do not describe the disease
itself, they should not be used as
principal diagnoses.
ICD–10–CM CODES PROPOSED TO BE ADDED TO THE VERSION 33 MCE ‘‘MANIFESTATION CODES NOT ALLOWED AS
PRINCIPAL DIAGNOSIS’’ EDIT
ICD–10–CM code
Code description
D75.81 ..........................
E08.00 ..........................
Myelofibrosis.
Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar
coma (NKHHC).
Diabetes mellitus due to underlying condition with hyperosmolarity with coma.
Diabetes mellitus due to underlying condition with ketoacidosis without coma.
Diabetes mellitus due to underlying condition with ketoacidosis with coma.
Diabetes mellitus due to underlying condition with diabetic nephropathy.
Diabetes mellitus due to underlying condition with diabetic chronic kidney disease.
Diabetes mellitus due to underlying condition with other diabetic kidney complication.
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema.
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema.
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema.
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema.
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema.
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular
edema.
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema.
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema.
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema.
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema.
Diabetes mellitus due to underlying condition with diabetic cataract.
Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication.
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified.
Diabetes mellitus due to underlying condition with diabetic mononeuropathy.
Diabetes mellitus due to underlying condition with diabetic polyneuropathy.
Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy.
Diabetes mellitus due to underlying condition with diabetic amyotrophy.
Diabetes mellitus due to underlying condition with other diabetic neurological complication.
Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene.
Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene.
Diabetes mellitus due to underlying condition with other circulatory complications.
Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy.
Diabetes mellitus due to underlying condition with other diabetic arthropathy.
Diabetes mellitus due to underlying condition with diabetic dermatitis.
Diabetes mellitus due to underlying condition with foot ulcer.
Diabetes mellitus due to underlying condition with other skin ulcer.
Diabetes mellitus due to underlying condition with other skin complications.
Diabetes mellitus due to underlying condition with periodontal disease.
Diabetes mellitus due to underlying condition with other oral complications.
Diabetes mellitus due to underlying condition with hypoglycemia with coma.
Diabetes mellitus due to underlying condition with hypoglycemia without coma.
Diabetes mellitus due to underlying condition with hyperglycemia.
Diabetes mellitus due to underlying condition with other specified complication.
Diabetes mellitus due to underlying condition with unspecified complications.
Diabetes mellitus due to underlying condition without complications.
E08.01 ..........................
E08.10 ..........................
E08.11 ..........................
E08.21 ..........................
E08.22 ..........................
E08.29 ..........................
E08.311 ........................
E08.319 ........................
E08.321 ........................
E08.329 ........................
E08.331 ........................
E08.339 ........................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
E08.341 ........................
E08.349 ........................
E08.351 ........................
E08.359 ........................
E08.36 ..........................
E08.39 ..........................
E08.40 ..........................
E08.41 ..........................
E08.42 ..........................
E08.43 ..........................
E08.44 ..........................
E08.49 ..........................
E08.51 ..........................
E08.52 ..........................
E08.59 ..........................
E08.610 ........................
E08.618 ........................
E08.620 ........................
E08.621 ........................
E08.622 ........................
E08.628 ........................
E08.630 ........................
E08.638 ........................
E08.641 ........................
E08.649 ........................
E08.65 ..........................
E08.69 ..........................
E08.8 ............................
E08.9 ............................
We are inviting public comment on
our proposal to add the above list of
ICD–10–CM diagnosis codes to the
‘‘Manifestation codes not allowed as
principal diagnosis’’ edit in the FY 2016
ICD–10 MCE Version 33.
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We also are proposing to revise the
language describing the ‘‘Procedure
inconsistent with LOS (Length of stay)’’
edit which lists ICD–10–PCS code
5A1955Z (Respiratory ventilation,
greater than 96 consecutive hours),
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effective for the FY 2016 ICD–10 MCE
Version 33. Currently, in Version 32 of
the ICD–10 MCE, the language
describing this ‘‘Procedure inconsistent
with LOS (Length of stay)’’ edit states:
‘‘The following procedure should only
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tkelley on DSK3SPTVN1PROD with PROPOSALS2
be coded on claims with a length of stay
of four days or greater.’’ Because the
code description of the ICD–10–PCS
code is for ventilation that occurs
greater than 96 hours, we are proposing
to revise the language for the edit to
read: ‘‘The following procedure code
should only be coded on claims with a
length of stay greater than 4 days.’’ This
proposed revision would clarify the
intent of this MCE edit. We are inviting
public comments on our proposal.
9. Proposed Changes to Surgical
Hierarchies
Some inpatient stays entail multiple
surgical procedures, each one of which,
occurring by itself, could result in
assignment of the case to a different
MS–DRG within the MDC to which the
principal diagnosis is assigned.
Therefore, it is necessary to have a
decision rule within the GROUPER by
which these cases are assigned to a
single MS–DRG. The surgical hierarchy,
an ordering of surgical classes from
most resource-intensive to least
resource-intensive, performs that
function. Application of this hierarchy
ensures that cases involving multiple
surgical procedures are assigned to the
MS–DRG associated with the most
resource-intensive surgical class.
Because the relative resource intensity
of surgical classes can shift as a function
of MS–DRG reclassification and
recalibrations, for FY 2016, we reviewed
the surgical hierarchy of each MDC, as
we have for previous reclassifications
and recalibrations, to determine if the
ordering of classes coincides with the
intensity of resource utilization.
A surgical class can be composed of
one or more MS–DRGs. For example, in
MDC 11, the surgical class ‘‘kidney
transplant’’ consists of a single MS–DRG
(MS–DRG 652) and the class ‘‘major
bladder procedures’’ consists of three
MS–DRGs (MS–DRGs 653, 654, and
655). Consequently, in many cases, the
surgical hierarchy has an impact on
more than one MS–DRG. The
methodology for determining the most
resource-intensive surgical class
involves weighting the average
resources for each MS–DRG by
frequency to determine the weighted
average resources for each surgical class.
For example, assume surgical class A
includes MS–DRGs 001 and 002 and
surgical class B includes MS–DRGs 003,
004, and 005. Assume also that the
average costs of MS–DRG 001 are higher
than that of MS–DRG 003, but the
average costs of MS–DRGs 004 and 005
are higher than the average costs of MS–
DRG 002. To determine whether
surgical class A should be higher or
lower than surgical class B in the
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surgical hierarchy, we would weigh the
average costs of each MS–DRG in the
class by frequency (that is, by the
number of cases in the MS–DRG) to
determine average resource
consumption for the surgical class. The
surgical classes would then be ordered
from the class with the highest average
resource utilization to that with the
lowest, with the exception of ‘‘other
O.R. procedures’’ as discussed below.
This methodology may occasionally
result in assignment of a case involving
multiple procedures to the lowerweighted MS–DRG (in the highest, most
resource-intensive surgical class) of the
available alternatives. However, given
that the logic underlying the surgical
hierarchy provides that the GROUPER
search for the procedure in the most
resource-intensive surgical class, in
cases involving multiple procedures,
this result is sometimes unavoidable.
We note that, notwithstanding the
foregoing discussion, there are a few
instances when a surgical class with a
lower average cost is ordered above a
surgical class with a higher average cost.
For example, the ‘‘other O.R.
procedures’’ surgical class is uniformly
ordered last in the surgical hierarchy of
each MDC in which it occurs, regardless
of the fact that the average costs for the
MS–DRG or MS–DRGs in that surgical
class may be higher than those for other
surgical classes in the MDC. The ‘‘other
O.R. procedures’’ class is a group of
procedures that are only infrequently
related to the diagnoses in the MDC, but
are still occasionally performed on
patients with cases assigned to the MDC
with these diagnoses. Therefore,
assignment to these surgical classes
should only occur if no other surgical
class more closely related to the
diagnoses in the MDC is appropriate.
A second example occurs when the
difference between the average costs for
two surgical classes is very small. We
have found that small differences
generally do not warrant reordering of
the hierarchy because, as a result of
reassigning cases on the basis of the
hierarchy change, the average costs are
likely to shift such that the higherordered surgical class has lower average
costs than the class ordered below it.
Based on the changes that we are
proposing to make for FY 2016, as
discussed in section II.G.3.e. of the
preamble of this FY 2016 IPPS/LTCH
PPS proposed rule, we are proposing to
revise the surgical hierarchy for MDC 5
(Diseases and Disorders of the
Circulatory System). Specifically, we are
proposing to delete MS–DRG 237 (Major
Cardiovascular Procedures with MCC)
and MS–DRG 238 (Major Cardiovascular
Procedures without MCC) from the
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24399
surgical hierarchy. We are proposing to
sequence proposed new MS–DRG 268
(Aortic and Heart Assist Procedures
Except Pulsation Balloon with MCC)
and proposed new MS–DRG 269 (Aortic
and Heart Assist Procedures Except
Pulsation Balloon without MCC) above
proposed new MS–DRG 270 (Other
Major Cardiovascular Procedures with
MCC), proposed new MS–DRG 271
(Other Major Cardiovascular Procedures
with CC), and proposed new MS–DRG
272 (Other Major Cardiovascular
Procedures without CC/MCC). We are
proposing to sequence proposed new
MS–DRGs 270, 271, and 272 above MS–
DRG 239 (Amputation for Circulatory
System Disorders Except Upper Limb &
Toe with MCC). In addition, we are
proposing to sequence proposed new
MS–DRG 273 (Percutaneous
Intracardiac Procedures with MCC) and
proposed new MS–DRG 274
(Percutaneous Intracardiac Procedures
without MCC) above MS–DRG 246
(Percutaneous Cardiovascular Procedure
with Drug-eluting Stent with MCC or 4+
Vessels/Stents).
We are inviting public comments on
our proposals.
10. Proposed Changes to the MS–DRG
Diagnosis Codes for FY 2016
a. Major Complications or Comorbidities
(MCCs) and Complications or
Comorbidities (CC) Severity Levels for
FY 2016
A complete updated MCC, CC, and
Non-CC Exclusion List is available via
the Internet on the CMS Web site at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/ as
follows:
• Table 6I (Complete MCC list);
• Table 6J (Complete CC list); and
• Table 6K (Complete list of CC
Exclusions).
b. Coronary Atherosclerosis Due to
Calcified Coronary Lesion
We received a request that we change
the severity levels for ICD–9–CM
diagnosis codes 414.2 (Chronic total
occlusion of coronary artery) and 414.4
(Coronary atherosclerosis due to
calcified coronary lesion) from non-CCs
to MCCs. The ICD–10–CM codes for
these diagnoses are I25.82 (Chronic total
occlusion of coronary artery) and I25.84
(Coronary atherosclerosis due to
calcified coronary lesion), respectively,
and both of these codes are currently
classified as non-CCs.
This issue was previously discussed
in the FY 2014 IPPS/LTCH PPS
proposed rule and final rule (78 FR
27522 and 78 FR 50541 through 50542,
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LTCH PPS proposed rule and final rule
SDX
414.4 ..................
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CC
level
SDX description
414.2 ..................
Chronic total occlusion of coronary
artery.
Coronary atherosclerosis due to
calcified coronary
lesion.
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Cnt 1
Cnt 1
impact
MedPAR file for ICD–9–CM diagnosis
codes 414.2 and 414.4. The following
table shows our findings.
Cnt 2
Cnt 2
impact
Cnt 3
Cnt 3
impact
Non-CC
14,655
1.393
21,222
2.098
20,615
3.046
Non-CC
We ran the data using the criteria
described in the FY 2008 IPPS final rule
with comment period (72 FR 47169) to
determine severity levels for procedures
in MS–DRGs. The C1 value reflects a
patient with no other secondary
diagnosis or with all other secondary
diagnoses that are non-CCs. The C2
value reflects a patient with at least one
other secondary diagnosis that is a CC,
but none that is an MCC. The C3 value
reflects a patient with at least one other
secondary diagnosis that is an MCC.
The table above shows that the C1
finding is 1.393 for ICD–9–CM diagnosis
code 414.2 and the C1 finding is 1.412
for ICD–9–CM diagnosis code 414.4. A
value close to 1.0 in the C1 field
suggests that the diagnosis produces the
same expected value as a non-CC. A
value close to 2.0 suggests the condition
is more like a CC than a non-CC, but not
as significant in resource usage as an
MCC. A value close to 3.0 suggests that
the condition is expected to consume
resources more similar to an MCC than
a CC or a non-CC. The C2 finding was
2.098 for ICD–9–CM diagnosis code
414.2, and the C2 finding was 2.148 for
ICD–9–CM diagnosis code 414.4. A C2
value close to 2.0 suggests the condition
is more like a CC than a non-CC, but not
as significant in resource usage as an
MCC when there is at least one other
secondary diagnosis that is a CC but
none that is an MCC. While the C1 value
of 1.393 for ICD–9–CM diagnosis code
414.2 and the C1 value of 1.412 for ICD–
9–CM diagnosis code 414.4 are above
the 1.0 value for a non-CC, these values
do not support the reclassification of
diagnosis codes 414.2 and 414.4 to
MCCs. As stated earlier, a value close to
3.0 suggests the condition is expected to
consume resources more similar to an
MCC than a CC or a non-CC. The C2
finding of 2.098 for ICD–9–CM
diagnosis code 414.2 and the C2 finding
of 2.148 for ICD–9–CM diagnosis code
414.4 also do not support reclassifying
these diagnosis codes to MCCs.
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(79 FR 28018 and 28019 and 79 FR
49903 and 49904, respectively).
We examined claims data from the
December 2014 update of the FY 2014
1,752
1.412
3,238
2.148
3,244
3.053
Our clinical advisors reviewed the
data and evaluated these conditions.
They recommended that we not change
the severity level of diagnosis codes
414.2 and 414.4 from a non-CC to an
MCC. Our clinical advisors do not
believe that these diagnoses would
increase the severity of illness level of
patients. Considering the C1 and C2
ratings of both diagnosis codes 414.2
and 414.4 and the input from our
clinical advisors, we are not proposing
to reclassify conditions represented by
diagnosis codes 414.2 and 414.4 to
MCCs. We are proposing to maintain
both of these conditions as non-CCs. As
stated earlier, the equivalent ICD–10–
CM codes for these conditions are codes
I25.82 and I25.84, respectively.
Therefore, based on the data and
clinical analysis, we are proposing to
maintain ICD–10–CM diagnosis codes
I25.82 and I25.84 as non-CCs. We are
inviting public comments on our
proposals.
c. Hydronephrosis
Some ICD–10–CM diagnosis codes
express conditions that are normally
coded in ICD–9–CM using two or more
ICD–9–CM diagnosis codes. CMS’ goal
in developing the ICD–10 MS–DRGs
was to ensure that a patient case is
assigned to the same MS–DRG,
regardless of whether the patient record
were to be coded in ICD–9–CM or ICD–
10–CM/PCS. When one of the ICD–10–
CM combination codes is used as a
principal diagnosis, the cluster of ICD–
9–CM codes that would be coded on an
ICD–9–CM record was evaluated. If one
of the ICD–9–CM codes in the cluster is
a CC or an MCC, the single ICD–10–CM
combination code used as a principal
diagnosis also must imply that the CC
or MCC is present. Appendix J of the
ICD–10 MS–DRG Definitions Manual
Version 32 includes two lists. Part 1 is
the list of principal diagnosis codes
where the ICD–10–CM code is its own
MCC. Part 2 is the list of principal
diagnosis codes where the ICD–10–CM
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code is its own CC. Appendix J of the
ICD–10 MS–DRG Definitions Manual
Version 32 is available via the CMS Web
site at: https://www.cms.gov/Medicare/
Coding/ICD10/ICD-10-MS-DRGConversion-Project.html.
We received a request that the ICD–
10–CM combination codes for
hydronephrosis due to ureteral stricture
and urinary stone (N13.1 and N13.2) be
flagged as principal diagnoses that can
act as their own CC for MS–DRG
grouping purposes.
In ICD–9–CM, code 591
(Hydronephrosis) is classified as a CC.
In ICD–10–CM, hydronephrosis is
reported with a combination code if the
hydronephrosis is due to a ureteral
stricture or urinary stone obstruction of
N13.1 (Hydronephrosis with ureteral
stricture, not elsewhere classified) and
N13.2 (Hydronephrosis with renal and
ureteral calculous obstruction). In ICD–
10–CM, these two codes (N13.1 and
N13.2) are classified as CCs, but these
codes are not recognized as principal
diagnoses that act as their own CC (they
are not included in the Appendix J of
the ICD–10 MS–DRG Definitions
Manual Version 32).
We agree with the requestor that ICD–
10–CM diagnosis codes N13.1 and
N13.2 should be flagged as principal
diagnosis codes that can act as their
own CC for MS–DRG grouping
purposes. Therefore, we are proposing
that diagnosis codes N13.1 and N13.2 be
added to the list of principal diagnoses
that act as their own CC in Appendix J
of the ICD–10 MS–DRG Definitions
Manual Version 32. We are inviting
public comments on our proposal.
11. Proposed Complications or
Comorbidity (CC) Exclusions List for FY
2016
a. Background of the CC List and the CC
Exclusions List
Under the IPPS MS–DRG
classification system, we have
developed a standard list of diagnoses
that are considered CCs. Historically, we
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developed this list using physician
panels that classified each diagnosis
code based on whether the diagnosis,
when present as a secondary condition,
would be considered a substantial
complication or comorbidity. A
substantial complication or comorbidity
was defined as a condition that, because
of its presence with a specific principal
diagnosis, would cause an increase in
the length of stay by at least 1 day in
at least 75 percent of the patients.
However, depending on the principal
diagnosis of the patient, some diagnoses
on the basic list of complications and
comorbidities may be excluded if they
are closely related to the principal
diagnosis. In FY 2008, we evaluated
each diagnosis code to determine its
impact on resource use and to
determine the most appropriate CC
subclassification (non-CC, CC, or MCC)
assignment. We refer readers to sections
II.D.2. and 3. of the preamble of the FY
2008 IPPS final rule with comment
period for a discussion of the refinement
of CCs in relation to the MS–DRGs we
adopted for FY 2008 (72 FR 47152
through 47171).
b. Proposed CC Exclusions List for FY
2016
In the September 1, 1987 final notice
(52 FR 33143) concerning changes to the
DRG classification system, we modified
the GROUPER logic so that certain
diagnoses included on the standard list
of CCs would not be considered valid
CCs in combination with a particular
principal diagnosis. We created the CC
Exclusions List for the following
reasons: (1) To preclude coding of CCs
for closely related conditions; (2) to
preclude duplicative or inconsistent
coding from being treated as CCs; and
(3) to ensure that cases are appropriately
classified between the complicated and
uncomplicated DRGs in a pair. As we
indicated above, we developed a list of
diagnoses, using physician panels, to
include those diagnoses that, when
present as a secondary condition, would
be considered a substantial
complication or comorbidity. In
previous years, we have made changes
to the list of CCs, either by adding new
CCs or deleting CCs already on the list.
In the May 19, 1987 proposed notice
(52 FR 18877) and the September 1,
1987 final notice (52 FR 33154), we
explained that the excluded secondary
diagnoses were established using the
following five principles:
• Chronic and acute manifestations of
the same condition should not be
considered CCs for one another;
• Specific and nonspecific (that is,
not otherwise specified (NOS))
diagnosis codes for the same condition
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should not be considered CCs for one
another;
• Codes for the same condition that
cannot coexist, such as partial/total,
unilateral/bilateral, obstructed/
unobstructed, and benign/malignant,
should not be considered CCs for one
another;
• Codes for the same condition in
anatomically proximal sites should not
be considered CCs for one another; and
• Closely related conditions should
not be considered CCs for one another.
The creation of the CC Exclusions List
was a major project involving hundreds
of codes. We have continued to review
the remaining CCs to identify additional
exclusions and to remove diagnoses
from the master list that have been
shown not to meet the definition of a
CC.4
The ICD–10 MS–DRGs Version 32 CC
Exclusion List is included as Appendix
C in the Definitions Manual available
via the Internet on the CMS Web site at:
https://www.cms.gov/Medicare/Coding/
ICD10/ICD-10-MS-DRG-ConversionProject.html.
For FY 2016, we are not proposing
any changes to the CC Exclusion List.
Because we are not proposing any
changes to the ICD–10 MS–DRGs CC
Exclusion List for FY 2016, we are not
publishing Table 6G (Additions to the
CC Exclusion List) or Table 6H
4 We refer readers to the FY 1989 final rule (53
FR 38485, September 30, 1988) for the revision
made for the discharges occurring in FY 1989; the
FY 1990 final rule (54 FR 36552, September 1,
1989) for the FY 1990 revision; the FY 1991 final
rule (55 FR 36126, September 4, 1990) for the FY
1991 revision; the FY 1992 final rule (56 FR 43209,
August 30, 1991) for the FY 1992 revision; the FY
1993 final rule (57 FR 39753, September 1, 1992)
for the FY 1993 revision; the FY 1994 final rule (58
FR 46278, September 1, 1993) for the FY 1994
revisions; the FY 1995 final rule (59 FR 45334,
September 1, 1994) for the FY 1995 revisions; the
FY 1996 final rule (60 FR 45782, September 1,
1995) for the FY 1996 revisions; the FY 1997 final
rule (61 FR 46171, August 30, 1996) for the FY 1997
revisions; the FY 1998 final rule (62 FR 45966,
August 29, 1997) for the FY 1998 revisions; the FY
1999 final rule (63 FR 40954, July 31, 1998) for the
FY 1999 revisions; the FY 2001 final rule (65 FR
47064, August 1, 2000) for the FY 2001 revisions;
the FY 2002 final rule (66 FR 39851, August 1,
2001) for the FY 2002 revisions; the FY 2003 final
rule (67 FR 49998, August 1, 2002) for the FY 2003
revisions; the FY 2004 final rule (68 FR 45364,
August 1, 2003) for the FY 2004 revisions; the FY
2005 final rule (69 FR 49848, August 11, 2004) for
the FY 2005 revisions; the FY 2006 final rule (70
FR 47640, August 12, 2005) for the FY 2006
revisions; the FY 2007 final rule (71 FR 47870) for
the FY 2007 revisions; the FY 2008 final rule (72
FR 47130) for the FY 2008 revisions; the FY 2009
final rule (73 FR 48510); the FY 2010 final rule (74
FR 43799); the FY 2011 final rule (75 FR 50114);
the FY 2012 final rule (76 FR 51542); the FY 2013
final rule (77 FR 53315); the FY 2014 final rule (78
FR 50541), and the FY 2015 final rule (79 FR
49905). In the FY 2000 final rule (64 FR 41490, July
30, 1999), we did not modify the CC Exclusions List
because we did not make any changes to the ICD–
9–CM codes for FY 2000.
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24401
(Deletions from the CC Exclusion List).
We have developed Table 6K (Complete
List of CC Exclusions), which is
available only via the Internet on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html. Because of the length of
Table 6K, we are not publishing it in the
Addendum to this proposed rule. Each
of the secondary diagnosis codes for
which there is an exclusion is listed in
Part 1 of Table 6K. Each of these
secondary diagnosis codes is indicated
as a CC or an MCC. If the CC or MCC
is allowed with all principal diagnoses,
the phrase ‘‘NoExcl’’ (for no exclusions)
follows the CC/MCC indicator.
Otherwise, a link is given to a collection
of diagnosis codes which, when used as
the principal diagnosis, will cause the
CC or MCC to be considered as only a
non-CC. Part 2 of Table 6K lists codes
that are assigned as an MCC only for
patients discharged alive. Otherwise,
the codes are assigned as a non-CC.
A complete updated MCC, CC, and
Non-CC Exclusions List is available via
the Internet on the CMS Web site at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/.
Because there are no proposed new,
revised, or deleted ICD–10–CM
diagnosis codes for FY 2016, we have
not developed Table 6A (New Diagnosis
Codes), Table 6C (Invalid Diagnosis
Codes), or Table 6E (Revised Diagnosis
Code Titles), for this proposed rule and
they are not published as part of this
proposed rule. We have developed
Table 6B (New Procedure Codes) for
new ICD–10–PCS codes which will be
implemented on October 1, 2015.
Because there are no proposed revised
or deleted procedure codes for FY 2016,
we have not developed Table 6D
(Invalid Procedure Codes) or Table 6F
(Revised Procedure Codes).
We are not proposing any additions or
deletions to the MS–DRG MCC List for
FY 2016 nor any additions or deletions
to the MS–DRG CC List for FY 2016.
Therefore, for this proposed rule, we
have not developed Tables 6I.1
(Additions to the MCC List), 6I.2
(Deletions to the MCC List), 6J.1
(Additions to the CC List), and 6J.2
(Deletions to the CC List), and they are
not published as part of this proposed
rule. We have developed Table 6M.1
(Additions to Principal Diagnosis Is Its
Own CC) to show the two proposed
additions to this list for the two
principal diagnosis codes acting as their
own CC.
The complete documentation of the
ICD–10 MS–DRG Version 32 GROUPER
logic, including the current CC
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Exclusions List, is available via the
Internet on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
ICD-10-MS-DRG-ConversionProject.html. The complete
documentation of the ICD–10 MS–DRG
GROUPER logic will be available on the
CMS Acute Inpatient PPS Web page
after the issuance of the final rule at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
12. Review of Procedure Codes in MS–
DRGs 981 Through 983, 984 Through
986, and 987 Through 989
Each year, we review cases assigned
to former CMS DRG 468 (Extensive O.R.
Procedure Unrelated to Principal
Diagnosis), CMS DRG 476 (Prostatic
O.R. Procedure Unrelated to Principal
Diagnosis), and CMS DRG 477
(Nonextensive O.R. Procedure Unrelated
to Principal Diagnosis) to determine
whether it would be appropriate to
change the procedures assigned among
these CMS DRGs. Under the MS–DRGs
that we adopted for FY 2008, CMS DRG
468 was split three ways and became
MS–DRGs 981, 982, and 983 (Extensive
O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and
without CC/MCC, respectively). CMS
DRG 476 became MS–DRGs 984, 985,
and 986 (Prostatic O.R. Procedure
Unrelated to Principal Diagnosis with
MCC, with CC, and without CC/MCC,
respectively). CMS DRG 477 became
MS–DRGs 987, 988, and 989
(Nonextensive O.R. Procedure Unrelated
to Principal Diagnosis with MCC, with
CC, and without CC/MCC, respectively).
MS–DRGs 981 through 983, 984
through 986, and 987 through 989
(formerly CMS DRGs 468, 476, and 477,
respectively) are reserved for those cases
in which none of the O.R. procedures
performed are related to the principal
diagnosis. These MS–DRGs are intended
to capture atypical cases, that is, those
cases not occurring with sufficient
frequency to represent a distinct,
recognizable clinical group. MS–DRGs
984 through 986 (previously CMS DRG
476) are assigned to those discharges in
which one or more of the following
prostatic procedures are performed and
are unrelated to the principal diagnosis:
• 60.0 (Incision of prostate);
• 60.12 (Open biopsy of prostate);
• 60.15 (Biopsy of periprostatic
tissue);
• 60.18 (Other diagnostic procedures
on prostate and periprostatic tissue);
• 60.21 (Transurethral
prostatectomy);
• 60.29 (Other transurethral
prostatectomy);
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• 60.61 (Local excision of lesion of
prostate);
• 60.69 (Prostatectomy, not elsewhere
classified);
• 60.81 (Incision of periprostatic
tissue);
• 60.82 (Excision of periprostatic
tissue);
• 60.93 (Repair of prostate);
• 60.94 (Control of (postoperative)
hemorrhage of prostate);
• 60.95 (Transurethral balloon
dilation of the prostatic urethra);
• 60.96 (Transurethral destruction of
prostate tissue by microwave
thermotherapy);
• 60.97 (Other transurethral
destruction of prostate tissue by other
thermotherapy); and
• 60.99 (Other operations on
prostate).
All remaining O.R. procedures are
assigned to MS–DRGs 981 through 983
and 987 through 989, with MS–DRGs
987 through 989 assigned to those
discharges in which the only procedures
performed are nonextensive procedures
that are unrelated to the principal
diagnosis.5
Our review of MedPAR claims data
showed that there are no cases that
merited movement or should logically
be assigned to any of the other MDCs.
Therefore, for FY 2016, we are not
proposing to change the procedures
assigned among these MS–DRGs.
5 The original list of the ICD–9–CM procedure
codes for the procedures we consider nonextensive
procedures, if performed with an unrelated
principal diagnosis, was published in Table 6C in
section IV. of the Addendum to the FY 1989 final
rule (53 FR 38591). As part of the FY 1991 final rule
(55 FR 36135), the FY 1992 final rule (56 FR 43212),
the FY 1993 final rule (57 FR 23625), the FY 1994
final rule (58 FR 46279), the FY 1995 final rule (59
FR 45336), the FY 1996 final rule (60 FR 45783),
the FY 1997 final rule (61 FR 46173), and the FY
1998 final rule (62 FR 45981), we moved several
other procedures from DRG 468 to DRG 477, and
some procedures from DRG 477 to DRG 468. No
procedures were moved in FY 1999, as noted in the
final rule (63 FR 40962), in the FY 2000 (64 FR
41496), in the FY 2001 (65 FR 47064), or in the FY
2002 (66 FR 39852). In the FY 2003 final rule (67
FR 49999), we did not move any procedures from
DRG 477. However, we did move procedure codes
from DRG 468 and placed them in more clinically
coherent DRGs. In the FY 2004 final rule (68 FR
45365), we moved several procedures from DRG
468 to DRGs 476 and 477 because the procedures
are nonextensive. In the FY 2005 final rule (69 FR
48950), we moved one procedure from DRG 468 to
477. In addition, we added several existing
procedures to DRGs 476 and 477. In FY 2006 (70
FR 47317), we moved one procedure from DRG 468
and assigned it to DRG 477. In FY 2007, we moved
one procedure from DRG 468 and assigned it to
DRGs 479, 553, and 554. In FYs 2008, 2009, 2010,
2011, 2012, 2013, 2014, and 2015, no procedures
were moved, as noted in the FY 2008 final rule with
comment period (72 FR 46241), in the FY 2009 final
rule (73 FR 48513), in the FY 2010 final rule (74
FR 43796), in the FY 2011 final rule (75 FR 50122),
in the FY 2012 final rule (76 FR 51549), in the FY
2013 final rule (77 FR 53321), in the FY 2014 final
rule (78 FR 50545); and in the FY 2015 final rule
(79 FR 49906).
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We are inviting public comments on
our proposal.
a. Moving Procedure Codes From MS–
DRGs 981 Through 983 or MS–DRGs
987 Through 989 Into MDCs
We annually conduct a review of
procedures producing assignment to
MS–DRGs 981 through 983 (Extensive
O.R. procedure unrelated to principal
diagnosis with MCC, with CC, and
without CC/MCC, respectively) or MS–
DRGs 987 through 989 (Nonextensive
O.R. procedure unrelated to principal
diagnosis with MCC, with CC, and
without CC/MCC, respectively) on the
basis of volume, by procedure, to see if
it would be appropriate to move
procedure codes out of these MS–DRGs
into one of the surgical MS–DRGs for
the MDC into which the principal
diagnosis falls. The data are arrayed in
two ways for comparison purposes. We
look at a frequency count of each major
operative procedure code. We also
compare procedures across MDCs by
volume of procedure codes within each
MDC.
We identify those procedures
occurring in conjunction with certain
principal diagnoses with sufficient
frequency to justify adding them to one
of the surgical MS–DRGs for the MDC in
which the diagnosis falls. As noted
above, there are no cases that merited
movement or that should logically be
assigned to any of the other MDCs.
Therefore, for FY 2016, we are not
proposing to remove any procedures
from MS–DRGs 981 through 983 or MS–
DRGs 987 through 989 into one of the
surgical MS–DRGs for the MDC into
which the principal diagnosis is
assigned.
We are inviting public comments on
our proposal.
b. Reassignment of Procedures Among
MS DRGs 981 Through 983, 984
Through 986, and 987 Through 989
(1) Annual Review of Procedures
We also annually review the list of
ICD–9–CM procedures that, when in
combination with their principal
diagnosis code, result in assignment to
MS–DRGs 981 through 983, 984 through
986 (Prostatic O.R. procedure unrelated
to principal diagnosis with MCC, with
CC, or without CC/MCC, respectively),
and 987 through 989, to ascertain
whether any of those procedures should
be reassigned from one of these three
MS DRGs to another of the three MS–
DRGs based on average costs and the
length of stay. We look at the data for
trends such as shifts in treatment
practice or reporting practice that would
make the resulting MS–DRG assignment
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illogical. If we find these shifts, we
would propose to move cases to keep
the MS–DRGs clinically similar or to
provide payment for the cases in a
similar manner. Generally, we move
only those procedures for which we
have an adequate number of discharges
to analyze the data.
There are no cases representing shifts
in treatment practice or reporting
practice that would make the resulting
MS–DRG assignment illogical, or that
merited movement so that cases should
logically be assigned to any of the other
MDCs. Therefore, for FY 2016, we are
not proposing to move any procedure
codes among these MS–DRGs.
(2) Review of Cases With Endovascular
Embolization Procedures for Epistaxis
During the comment period for the FY
2015 IPPS/LTCH PPS proposed rule, we
received a public comment expressing
concern regarding specific procedure
codes that are assigned to MS–DRGs 981
through 983; 984 through 986; and 987
through 989 in relation to our
discussion of the annual review of these
MS–DRGs in section II.G.12. of that
proposed rule (79 FR 28020). The
commenter noted that the endovascular
embolization of the arteries of the
branches of the internal maxillary artery
is frequently performed for intractable
posterior epistaxis (nosebleed). The
commenter stated that, currently,
diagnosis code 784.7 (Epistaxis)
reported with procedure codes 39.75
(Endovascular embolization or
occlusion of vessel(s) of head or neck
using bare coils) and 39.76
(Endovascular embolization or
occlusion of vessel(s) of head or neck
using bioactive coils) groups to MS–
DRGs 981, 982, and 983. The
commenter indicated that it also found
this grouping with the ICD–10 MS–
24403
DRGs Version 31 using ICD–10–CM
diagnosis code R04.0 (Epistaxis)
reported with artery occlusion
procedure codes. The commenter
requested that CMS review these
groupings and consider the possibility
of reassigning these epistaxis cases with
endovascular embolization procedure
codes into a more specific MS–DRG.
We considered this public comment
to be outside of the scope of the FY 2015
IPPS/LTCH PPS proposed rule and,
therefore, did not address it in the FY
2015 IPPS/LTCH PPS final rule.
However, we indicated that we would
consider this public comment for
possible proposals in future rulemaking
as part of our annual review process.
ICD–10–PCS provides more detailed
codes for endovascular embolization or
occlusion of vessel(s) of head or neck
using bare coils and bioactive coils
which are listed in the following table:
ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION OR OCCLUSION OF VESSEL(S) OF HEAD OR NECK USING BARE
COILS AND BIOACTIVE COILS
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
03LG0BZ ......................
03LG0DZ ......................
03LG3BZ ......................
03LG3DZ ......................
03LG4BZ ......................
03LG4DZ ......................
03LH0BZ .......................
03LH0DZ ......................
03LH3BZ .......................
03LH3DZ ......................
03LH4BZ .......................
03LH4DZ ......................
03LJ0BZ .......................
03LJ0DZ .......................
03LJ3BZ .......................
03LJ3DZ .......................
03LJ4BZ .......................
03LJ4DZ .......................
03LK0BZ .......................
03LK0DZ .......................
03LK3BZ .......................
03LK3DZ .......................
03LK4BZ .......................
03LK4DZ .......................
03LL0BZ .......................
03LL0DZ .......................
03LL3BZ .......................
03LL3DZ .......................
03LL4BZ .......................
03LL4DZ .......................
03LM0BZ ......................
03LM0DZ ......................
03LM3BZ ......................
03LM3DZ ......................
03LM4BZ ......................
03LM4DZ ......................
03LN0BZ .......................
03LN0DZ ......................
03LN3BZ .......................
03LN3DZ ......................
03LN4BZ .......................
03LN4DZ ......................
03LP0BZ .......................
03LP0DZ .......................
VerDate Sep<11>2014
Code description
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
Occlusion
18:20 Apr 29, 2015
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
intracranial artery with bioactive intraluminal device, open approach.
intracranial artery with intraluminal device, open approach.
intracranial artery with bioactive intraluminal device, percutaneous approach.
intracranial artery with intraluminal device, percutaneous approach.
intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach.
intracranial artery with intraluminal device, percutaneous endoscopic approach.
right common carotid artery with bioactive intraluminal device, open approach.
right common carotid artery with intraluminal device, open approach.
right common carotid artery with bioactive intraluminal device, percutaneous approach.
right common carotid artery with intraluminal device, percutaneous approach.
right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
right common carotid artery with intraluminal device, percutaneous endoscopic approach.
left common carotid artery with bioactive intraluminal device, open approach.
left common carotid artery with intraluminal device, open approach.
left common carotid artery with bioactive intraluminal device, percutaneous approach.
left common carotid artery with intraluminal device, percutaneous approach.
left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
left common carotid artery with intraluminal device, percutaneous endoscopic approach.
right internal carotid artery with bioactive intraluminal device, open approach.
right internal carotid artery with intraluminal device, open approach.
right internal carotid artery with bioactive intraluminal device, percutaneous approach.
right internal carotid artery with intraluminal device, percutaneous approach.
right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
right internal carotid artery with intraluminal device, percutaneous endoscopic approach.
left internal carotid artery with bioactive intraluminal device, open approach.
left internal carotid artery with intraluminal device, open approach.
left internal carotid artery with bioactive intraluminal device, percutaneous approach.
left internal carotid artery with intraluminal device, percutaneous approach.
left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
left internal carotid artery with intraluminal device, percutaneous endoscopic approach.
right external carotid artery with bioactive intraluminal device, open approach.
right external carotid artery with intraluminal device, open approach.
right external carotid artery with bioactive intraluminal device, percutaneous approach.
right external carotid artery with intraluminal device, percutaneous approach.
right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
right external carotid artery with intraluminal device, percutaneous endoscopic approach.
left external carotid artery with bioactive intraluminal device, open approach.
left external carotid artery with intraluminal device, open approach.
left external carotid artery with bioactive intraluminal device, percutaneous approach.
left external carotid artery with intraluminal device, percutaneous approach.
left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
left external carotid artery with intraluminal device, percutaneous endoscopic approach.
right vertebral artery with bioactive intraluminal device, open approach.
right vertebral artery with intraluminal device, open approach.
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ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION OR OCCLUSION OF VESSEL(S) OF HEAD OR NECK USING BARE
COILS AND BIOACTIVE COILS—Continued
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICD–10–PCS code
03LP3BZ .......................
03LP3DZ .......................
03LP4BZ .......................
03LP4DZ .......................
03LQ0BZ ......................
03LQ0DZ ......................
03LQ3BZ ......................
03LQ3DZ ......................
03LQ4BZ ......................
03LQ4DZ ......................
03VG0BZ ......................
03VG0DZ ......................
03VG3BZ ......................
03VG3DZ ......................
03VG4BZ ......................
03VG4DZ ......................
03VH0BZ ......................
03VH0DZ ......................
03VH3BZ ......................
03VH3DZ ......................
03VH4BZ ......................
03VH4DZ ......................
03VJ0BZ .......................
03VJ0DZ .......................
03VJ3BZ .......................
03VJ3DZ .......................
03VJ4BZ .......................
03VJ4DZ .......................
03VK0BZ ......................
03VK0DZ ......................
03VK3BZ ......................
03VK3DZ ......................
03VK4BZ ......................
03VK4DZ ......................
03VL0BZ .......................
03VL0DZ .......................
03VL3BZ .......................
03VL3DZ .......................
03VL4BZ .......................
03VL4DZ .......................
03VM0BZ ......................
03VM0DZ ......................
03VM3BZ ......................
03VM3DZ ......................
03VM4BZ ......................
03VM4DZ ......................
03VN0BZ ......................
03VN0DZ ......................
03VN3BZ ......................
03VN3DZ ......................
03VN4BZ ......................
03VN4DZ ......................
03VP0BZ ......................
03VP0DZ ......................
03VP3BZ ......................
03VP3DZ ......................
03VP4BZ ......................
03VP4DZ ......................
03VQ0BZ ......................
03VQ0DZ ......................
03VQ3BZ ......................
03VQ3DZ ......................
03VQ4BZ ......................
03VQ4DZ ......................
03VR0DZ ......................
03VR3DZ ......................
03VR4DZ ......................
03VS0DZ ......................
03VS3DZ ......................
03VS4DZ ......................
03VT0DZ ......................
VerDate Sep<11>2014
Code description
Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous approach.
Occlusion of right vertebral artery with intraluminal device, percutaneous approach.
Occlusion of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of right vertebral artery with intraluminal device, percutaneous endoscopic approach.
Occlusion of left vertebral artery with bioactive intraluminal device, open approach.
Occlusion of left vertebral artery with intraluminal device, open approach.
Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous approach.
Occlusion of left vertebral artery with intraluminal device, percutaneous approach.
Occlusion of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Occlusion of left vertebral artery with intraluminal device, percutaneous endoscopic approach.
Restriction of intracranial artery with bioactive intraluminal device, open approach.
Restriction of intracranial artery with intraluminal device, open approach.
Restriction of intracranial artery with bioactive intraluminal device, percutaneous approach.
Restriction of intracranial artery with intraluminal device, percutaneous approach.
Restriction of intracranial artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of intracranial artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right common carotid artery with bioactive intraluminal device, open approach.
Restriction of right common carotid artery with intraluminal device, open approach.
Restriction of right common carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right common carotid artery with intraluminal device, percutaneous approach.
Restriction of right common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right common carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left common carotid artery with bioactive intraluminal device, open approach.
Restriction of left common carotid artery with intraluminal device, open approach.
Restriction of left common carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left common carotid artery with intraluminal device, percutaneous approach.
Restriction of left common carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left common carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right internal carotid artery with bioactive intraluminal device, open approach.
Restriction of right internal carotid artery with intraluminal device, open approach.
Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right internal carotid artery with intraluminal device, percutaneous approach.
Restriction of right internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left internal carotid artery with bioactive intraluminal device, open approach.
Restriction of left internal carotid artery with intraluminal device, open approach.
Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left internal carotid artery with intraluminal device, percutaneous approach.
Restriction of left internal carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left internal carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right external carotid artery with bioactive intraluminal device, open approach.
Restriction of right external carotid artery with intraluminal device, open approach.
Restriction of right external carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of right external carotid artery with intraluminal device, percutaneous approach.
Restriction of right external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right external carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left external carotid artery with bioactive intraluminal device, open approach.
Restriction of left external carotid artery with intraluminal device, open approach.
Restriction of left external carotid artery with bioactive intraluminal device, percutaneous approach.
Restriction of left external carotid artery with intraluminal device, percutaneous approach.
Restriction of left external carotid artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left external carotid artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right vertebral artery with bioactive intraluminal device, open approach.
Restriction of right vertebral artery with intraluminal device, open approach.
Restriction of right vertebral artery with bioactive intraluminal device, percutaneous approach.
Restriction of right vertebral artery with intraluminal device, percutaneous approach.
Restriction of right vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of right vertebral artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left vertebral artery with bioactive intraluminal device, open approach.
Restriction of left vertebral artery with intraluminal device, open approach.
Restriction of left vertebral artery with bioactive intraluminal device, percutaneous approach.
Restriction of left vertebral artery with intraluminal device, percutaneous approach.
Restriction of left vertebral artery with bioactive intraluminal device, percutaneous endoscopic approach.
Restriction of left vertebral artery with intraluminal device, percutaneous endoscopic approach.
Restriction of face artery with intraluminal device, open approach.
Restriction of face artery with intraluminal device, percutaneous approach.
Restriction of face artery with intraluminal device, percutaneous endoscopic approach.
Restriction of right temporal artery with intraluminal device, open approach.
Restriction of right temporal artery with intraluminal device, percutaneous approach.
Restriction of right temporal artery with intraluminal device, percutaneous endoscopic approach.
Restriction of left temporal artery with intraluminal device, open approach.
18:20 Apr 29, 2015
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ICD–10–PCS CODES FOR ENDOVASCULAR EMBOLIZATION OR OCCLUSION OF VESSEL(S) OF HEAD OR NECK USING BARE
COILS AND BIOACTIVE COILS—Continued
ICD–10–PCS code
03VT3DZ
03VT4DZ
03VU0DZ
03VU3DZ
03VU4DZ
03VV0DZ
03VV3DZ
03VV4DZ
......................
......................
......................
......................
......................
......................
......................
......................
Code description
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
Restriction
of
of
of
of
of
of
of
of
left temporal artery with intraluminal device, percutaneous approach.
left temporal artery with intraluminal device, percutaneous endoscopic approach.
right thyroid artery with intraluminal device, open approach.
right thyroid artery with intraluminal device, percutaneous approach.
right thyroid artery with intraluminal device, percutaneous endoscopic approach.
left thyroid artery with intraluminal device, open approach.
left thyroid artery with intraluminal device, percutaneous approach.
left thyroid artery with intraluminal device, percutaneous endoscopic approach.
We examined claims data from the
December 2014 update of the FY 2014
MedPAR file for cases with diagnosis
code 784.7 reported with procedure
codes 39.75 and 39.76 in MS–DRGs 981,
982, and 983. The following table shows
our findings.
ENDOVASCULAR EMBOLIZATION PROCEDURES FOR EPISTAXIS
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MS–DRG 981—All cases ............................................................................................................
MS–DRG 981—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.75 ........................................................................................................................................
MS–DRG 981—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.76 ........................................................................................................................................
MS–DRG 982—All cases ............................................................................................................
MS–DRG 982—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.75 ........................................................................................................................................
MS–DRG 982—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.76 ........................................................................................................................................
MS–DRG 983—All cases ............................................................................................................
MS–DRG 983—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.75 ........................................................................................................................................
MS–DRG 983—Epistaxis cases with principal diagnosis code 784.7 and procedure code
39.76 ........................................................................................................................................
We found only 35 epistaxis cases with
procedure code 39.75 reported and 8
cases with procedure code 39.76
reported among MS–DRGs 981, 982, and
983. The use of endovascular
embolizations for epistaxis appears to be
rare. The average costs for the cases
with procedure code 39.75 in MS–DRGs
981, 982, and 983 are similar to the
average costs for all cases in MS–DRGs
981, 982, and 983, respectively. The
average costs for the cases with
procedure code 39.75 in MS–DRGs 981,
982, and 983 were $34,655, $17,725,
and $10,532, respectively, compared to
$33,080, $19,392, and $12,760 for all
cases in MS–DRGs 981, 982, and 983.
The average costs for cases with
procedure code 39.76 in MS–DRGs 981,
982, and 983 were $50,081, $11,010,
and $16,658, respectively, and were
significantly greater than all cases in
MS–DRGs 981 and 983. However, as
stated earlier, there were only 8 cases
reported with procedure code 39.76. As
explained previously, MS–DRGs 981,
982, and 983 were created for operating
room procedures that are unrelated to
the principal diagnosis. Because there
VerDate Sep<11>2014
18:20 Apr 29, 2015
Jkt 235001
were so few cases reported, this does
not appear to be a common procedure
for epistaxis. There were not enough
cases to base a change of MS–DRG
assignment for these cases.
Our clinical advisors reviewed this
issue and did not identify any new MS–
DRG assignment that would be more
appropriate for these rare cases. They
advised us to maintain the current MS–
DRG structure within MS–DRGs 981,
982, and 983.
Based on the results of the
examination of the claims data and the
recommendations from our clinical
advisors, we are not proposing to create
new MS–DRG assignments for epistaxis
cases receiving endovascular
embolization procedures. We are
proposing to maintain the current MS–
DRG structure for epistaxis cases
receiving endovascular embolization
procedures and are not proposing any
updates to MS–DRGs 981, 982, and 983.
We are inviting public comments on our
proposal.
PO 00000
Average
length of
stay
Number of
cases
MS–DRG
Frm 00083
Fmt 4701
Sfmt 4702
Average
costs
21,118
12.38
$33,080
8
6.50
34,655
2
13,657
12.50
7.14
50,081
19,392
22
3.14
17,725
2
2,989
2.0
3.60
11,010
12,760
5
2.60
10,532
4
1.50
16,658
c. Adding Diagnosis or Procedure Codes
to MDCs
Based on the review of cases in the
MDCs, as described above in sections
II.G.2. through 7. of the preamble of this
proposed rule, we are not proposing to
add any diagnosis or procedure codes to
MDCs for FY 2016. We are inviting
public comments on our proposal.
13. Proposed Changes to the ICD–9–CM
System
a. ICD–10 Coordination and
Maintenance Committee
In September 1985, the ICD–9–CM
Coordination and Maintenance
Committee was formed. This is a
Federal interdepartmental committee,
co-chaired by the National Center for
Health Statistics (NCHS), the Centers for
Disease Control and Prevention, and
CMS, charged with maintaining and
updating the ICD–9–CM system. The
final update to ICD–9–CM codes was to
be made on October 1, 2013. Thereafter,
the name of the Committee was changed
to the ICD–10 Coordination and
Maintenance Committee, effective with
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the March 19–20, 2014 meeting. The
ICD–10 Coordination and Maintenance
Committee addresses updates to the
ICD–10–CM, ICD–10–PCS, and ICD–9–
CM coding systems. The Committee is
jointly responsible for approving coding
changes, and developing errata,
addenda, and other modifications to the
coding systems to reflect newly
developed procedures and technologies
and newly identified diseases. The
Committee is also responsible for
promoting the use of Federal and nonFederal educational programs and other
communication techniques with a view
toward standardizing coding
applications and upgrading the quality
of the classification system.
The official list of ICD–9–CM
diagnosis and procedure codes by fiscal
year can be found on the CMS Web site
at: https://www.cms.gov/Medicare/
Coding/ICD9ProviderDiagnosticCodes/
codes.html. The official list of ICD–10–
CM and ICD–10–PCS codes can be
found on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
index.html.
The NCHS has lead responsibility for
the ICD–10–CM and ICD–9–CM
diagnosis codes included in the Tabular
List and Alphabetic Index for Diseases,
while CMS has lead responsibility for
the ICD–10–PCS and ICD–9–CM
procedure codes included in the
Tabular List and Alphabetic Index for
Procedures.
The Committee encourages
participation in the above process by
health-related organizations. In this
regard, the Committee holds public
meetings for discussion of educational
issues and proposed coding changes.
These meetings provide an opportunity
for representatives of recognized
organizations in the coding field, such
as the American Health Information
Management Association (AHIMA), the
American Hospital Association (AHA),
and various physician specialty groups,
as well as individual physicians, health
information management professionals,
and other members of the public, to
contribute ideas on coding matters.
After considering the opinions
expressed at the public meetings and in
writing, the Committee formulates
recommendations, which then must be
approved by the agencies.
The Committee presented proposals
for coding changes for implementation
in FY 2016 at a public meeting held on
September 23–24, 2014, and finalized
the coding changes after consideration
of comments received at the meetings
and in writing by November 15, 2014.
The Committee held its 2015 meeting
on March 18–19, 2015. It was
announced at this meeting that any new
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18:20 Apr 29, 2015
Jkt 235001
ICD–10–CM/PCS codes for which there
was consensus of public support and for
which complete tabular and indexing
changes would be made by May 2015
would be included in the October 1,
2015 update to ICD–10–CM/ICD–10–
PCS. For FY 2016, there are no new,
revised, or deleted ICD–10–CM
diagnosis codes. For FY 2016, there are
new ICD–10–PCS procedure codes that
are included in Table 6B (New
Procedure Codes). However, there are
no revised or deleted ICD–10–PCS
procedure codes. There also are no new
ICD–9–CM diagnosis or procedure codes
because ICD–9–CM will be replaced by
ICD–10–CM/ICD–10–PCS for services
provided on or after October 1, 2015.
Copies of the agenda, handouts, and
access to the live stream videos for the
procedure codes discussions at the
Committee’s September 23–24, 2014
meeting and March 18–19, 2015 meeting
can be obtained from the CMS Web site
at: https://www.cms.gov/Medicare/
Coding/ICD9ProviderDiagnosticCodes/
index.html?redirect=/
icd9ProviderDiagnosticCodes/03_
meetings.asp. The agenda, handouts and
minutes of the diagnosis codes
discussions at the September 23–24,
2014 meeting and March 18–19, 2015
meeting are found at: https://
www.cdc.gov/nchs/icd/icd9cmmaintenance.html. These Web sites also
provide detailed information about the
Committee, including information on
requesting a new code, attending a
Committee meeting, timeline
requirements and meeting dates.
We encourage commenters to address
suggestions on coding issues involving
diagnosis codes to: Donna Pickett, CoChairperson, ICD–10 Coordination and
Maintenance Committee, NCHS, Room
2402, 3311 Toledo Road, Hyattsville,
MD 20782. Comments may be sent by
Email to: dfp4@cdc.gov.
Questions and comments concerning
the procedure codes should be
addressed to: Patricia Brooks, CoChairperson, ICD–10 Coordination and
Maintenance Committee, CMS, Center
for Medicare, Hospital and Ambulatory
Policy Group, Division of Acute Care,
C4–08–06, 7500 Security Boulevard,
Baltimore, MD 21244–1850. Comments
may be sent by Email to:
patricia.brooks2@cms.hhs.gov.
In the September 7, 2001 final rule
implementing the IPPS new technology
add-on payments (66 FR 46906), we
indicated we would attempt to include
proposals for procedure codes that
would describe new technology
discussed and approved at the Spring
meeting as part of the code revisions
effective the following October.
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Section 503(a) of Public Law 108–173
included a requirement for updating
ICD–9–CM codes twice a year instead of
a single update on October 1 of each
year. This requirement was included as
part of the amendments to the Act
relating to recognition of new
technology under the IPPS. Section
503(a) amended section 1886(d)(5)(K) of
the Act by adding a clause (vii) which
states that the Secretary shall provide
for the addition of new diagnosis and
procedure codes on April 1 of each year,
but the addition of such codes shall not
require the Secretary to adjust the
payment (or diagnosis-related group
classification) until the fiscal year that
begins after such date. This requirement
improves the recognition of new
technologies under the IPPS system by
providing information on these new
technologies at an earlier date. Data will
be available 6 months earlier than
would be possible with updates
occurring only once a year on October
1.
While section 1886(d)(5)(K)(vii) of the
Act states that the addition of new
diagnosis and procedure codes on April
1 of each year shall not require the
Secretary to adjust the payment, or DRG
classification, under section 1886(d) of
the Act until the fiscal year that begins
after such date, we have to update the
DRG software and other systems in
order to recognize and accept the new
codes. We also publicize the code
changes and the need for a mid-year
systems update by providers to identify
the new codes. Hospitals also have to
obtain the new code books and encoder
updates, and make other system changes
in order to identify and report the new
codes.
The ICD–10 (previously the ICD–9–
CM) Coordination and Maintenance
Committee holds its meetings in the
spring and fall in order to update the
codes and the applicable payment and
reporting systems by October 1 of each
year. Items are placed on the agenda for
the Committee meeting if the request is
received at least 2 months prior to the
meeting. This requirement allows time
for staff to review and research the
coding issues and prepare material for
discussion at the meeting. It also allows
time for the topic to be publicized in
meeting announcements in the Federal
Register as well as on the CMS Web site.
The public decides whether or not to
attend the meeting based on the topics
listed on the agenda. Final decisions on
code title revisions are currently made
by March 1 so that these titles can be
included in the IPPS proposed rule. A
complete addendum describing details
of all diagnosis and procedure coding
changes, both tabular and index, is
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published on the CMS and NCHS Web
sites in May of each year. Publishers of
coding books and software use this
information to modify their products
that are used by health care providers.
This 5-month time period has proved to
be necessary for hospitals and other
providers to update their systems.
A discussion of this timeline and the
need for changes are included in the
December 4–5, 2005 ICD–9–CM
Coordination and Maintenance
Committee Meeting minutes. The public
agreed that there was a need to hold the
fall meetings earlier, in September or
October, in order to meet the new
implementation dates. The public
provided comment that additional time
would be needed to update hospital
systems and obtain new code books and
coding software. There was considerable
concern expressed about the impact this
new April update would have on
providers.
In the FY 2005 IPPS final rule, we
implemented section 1886(d)(5)(K)(vii)
of the Act, as added by section 503(a)
of Public Law 108–173, by developing a
mechanism for approving, in time for
the April update, diagnosis and
procedure code revisions needed to
describe new technologies and medical
services for purposes of the new
technology add-on payment process. We
also established the following process
for making these determinations. Topics
considered during the Fall ICD–10
(previously ICD–9–CM) Coordination
and Maintenance Committee meeting
are considered for an April 1 update if
a strong and convincing case is made by
the requestor at the Committee’s public
meeting. The request must identify the
reason why a new code is needed in
April for purposes of the new
technology process. The participants at
the meeting and those reviewing the
Committee meeting summary report are
provided the opportunity to comment
on this expedited request. All other
topics are considered for the October 1
update. Participants at the Committee
meeting are encouraged to comment on
all such requests. There were no
requests approved for an expedited
April l, 2015 implementation of a code
at the September 23–24, 2014
Committee meeting. Therefore, there
were no new codes implemented on
April 1, 2015.
ICD–9–CM addendum and code title
information is published on the CMS
Web site at: https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/
index.html?redirect=/
icd9ProviderDiagnosticCodes/
01overview.asp#TopofPage. ICD–10–CM
and ICD–10–PCS addendum and code
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18:20 Apr 29, 2015
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title information is published on the
CMS Web site at https://www.cms.gov/
Medicare/Coding/ICD10/.
Information on ICD–10–CM diagnosis
codes, along with the Official ICD–10–
CM Coding Guidelines, can also be
found on the CDC Web site at: https://
www.cdc.gov/nchs/.
Information on new, revised, and
deleted ICD–10–CM/ICD–10–PCS codes
is also provided to the AHA for
publication in the Coding Clinic for
ICD–10. AHA also distributes
information to publishers and software
vendors.
CMS also sends copies of all ICD–10–
CM and ICD–10–PCS coding changes to
its Medicare contractors for use in
updating their systems and providing
education to providers.
The code titles are adopted as part of
the ICD–10 (previously ICD–9–CM)
Coordination and Maintenance
Committee process. Therefore, although
we publish the code titles in the IPPS
proposed and final rules, they are not
subject to comment in the proposed or
final rules.
b. Code Freeze
In the January 16, 2009 ICD–10–CM
and ICD–10–PCS final rule (74 FR
3340), there was a discussion of the
need for a partial or total freeze in the
annual updates to both ICD–9–CM and
ICD–10–CM and ICD–10–PCS codes.
The public comment addressed in that
final rule stated that the annual code set
updates should cease l year prior to the
implementation of ICD–10. The
commenters stated that this freeze of
code updates would allow for
instructional and/or coding software
programs to be designed and purchased
early, without concern that an upgrade
would take place immediately before
the compliance date, necessitating
additional updates and purchases.
HHS responded to comments in the
ICD–10 final rule that the ICD–9–CM
Coordination and Maintenance
Committee has jurisdiction over any
action impacting the ICD–9–CM and
ICD–10 code sets. Therefore, HHS
indicated that the issue of consideration
of a moratorium on updates to the ICD–
9–CM, ICD–10–CM, and ICD–10–PCS
code sets in anticipation of the adoption
of ICD–10–CM and ICD–10–PCS would
be addressed through the Committee at
a future public meeting.
The code freeze was discussed at
multiple meetings of the ICD–9–CM
Coordination and Maintenance
Committee and public comment was
actively solicited. The Committee
evaluated all comments from
participants attending the Committee
meetings as well as written comments
PO 00000
Frm 00085
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Sfmt 4702
24407
that were received. The Committee also
considered the delay in implementation
of ICD–10 until October 1, 2014. There
was an announcement at the September
19, 2012 ICD–9–CM Coordination and
Maintenance Committee meeting that a
partial freeze of both ICD–9–CM and
ICD–10 codes will be implemented as
follows:
• The last regular annual update to
both ICD–9–CM and ICD–10 code sets
was made on October 1, 2011.
• On October 1, 2012 and October 1,
2013, there were to be only limited code
updates to both ICD–9–CM and ICD–10
code sets to capture new technology and
new diseases.
• On October 1, 2014, there were to
be only limited code updates to ICD–10
code sets to capture new technology and
diagnoses as required by section 503(a)
of Public Law 108–173. There were to
be no updates to ICD–9–CM on October
1, 2014.
• On October 1, 2015, one year after
the originally scheduled
implementation of ICD–10, regular
updates to ICD–10 were to begin.
On May 15, 2014, CMS posted an
updated Partial Code Freeze schedule
on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/ICD10/
ICD-9-CM-Coordination-andMaintenance-Committee-Meetings.html.
This updated schedule provided
information on the extension of the
partial code freeze until 1 year after the
implementation of ICD–10. As stated
earlier, on April 1, 2014, the Protecting
Access to Medicare Act of 2014 (PAMA)
(Pub. L. 113–93) was enacted, which
specified that the Secretary may not
adopt ICD–10 prior to October 1, 2015.
Accordingly, the U.S. Department of
Health and Human Services released a
final rule in the Federal Register on
August 4, 2014 (79 FR 45128 through
45134) that included a new compliance
date that requires the use of ICD–10
beginning October 1, 2015. The August
4, 2014 final rule is available for
viewing on the Internet at: https://
www.gpo.gov/fdsys/pkg/FR-2014-08-04/
pdf/2014-18347.pdf. That final rule also
requires HIPAA covered entities to
continue to use ICD–9–CM through
September 30, 2015. Accordingly, the
updated schedule for the partial code
freeze is as follows:
• The last regular annual updates to
both ICD–9–CM and ICD–10 code sets
were made on October 1, 2011.
• On October 1, 2012, October 1,
2013, and October 1, 2014, there were
only limited code updates to both the
ICD–9–CM and ICD–10 code sets to
capture new technologies and diseases
as required by section 1886(d)(5)(K) of
the Act.
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• On October 1, 2015, there will be
only limited code updates to ICD–10
code sets to capture new technologies
and diagnoses as required by section
1886(d)(5)(K) of the Act. There will be
no updates to ICD–9–CM, as it will no
longer be used for reporting.
• On October 1, 2016 (1 year after
implementation of ICD–10), regular
updates to ICD–10 will begin.
The ICD–10 (previously ICD–9–CM)
Coordination and Maintenance
Committee announced that it would
continue to meet twice a year during the
freeze. At these meetings, the public
will be encouraged to comment on
whether or not requests for new
diagnosis and procedure codes should
be created based on the need to capture
new technology and new diseases. Any
code requests that do not meet the
criteria will be evaluated for
implementation within ICD–10 one year
after the implementation of ICD–10,
once the partial freeze is ended.
Complete information on the partial
code freeze and discussions of the
issues at the Committee meetings can be
found on the ICD–10 Coordination and
Maintenance Committee Web site at:
https://www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/
meetings.html. A summary of the
September 19, 2012 Committee meeting,
along with both written and audio
transcripts of this meeting, is posted on
the Web site at: https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials-Items/
2012-09-19-MeetingMaterials.html.
This partial code freeze has
dramatically decreased the number of
codes created each year as shown by the
following information.
TOTAL NUMBER OF CODES AND CHANGES IN TOTAL NUMBER OF CODES PER FISCAL YEAR
ICD–9–CM Codes
Fiscal Year
Number
tkelley on DSK3SPTVN1PROD with PROPOSALS2
FY 2009 (October 1, 2008):
Diagnoses ..........................................
Procedures ........................................
FY 2010 (October 1, 2009):
Diagnoses ..........................................
Procedures ........................................
FY 2011(October 1, 2010):
Diagnoses ..........................................
Procedures ........................................
FY 2012 (October 1, 2011):
Diagnoses ..........................................
Procedures ........................................
FY 2013 (October 1, 2012):
Diagnoses ..........................................
Procedures ........................................
FY 2014 (October 1, 2013):
Diagnoses ..........................................
Procedures ........................................
FY 2015 (October 1, 2014):
Diagnoses ..........................................
Procedures ........................................
FY 2016 (October 1, 2015):
Diagnoses ..........................................
Procedures ........................................
18:20 Apr 29, 2015
Jkt 235001
Change
Fiscal Year
14,025
3,824
348
56
14,315
3,838
290
14
14,432
3,859
135
18
14,567
3,878
0
1
14,567
3,882
0
4
14,567
3,882
0
0
14,567
3,882
0
0
FY
FY
FY
FY
FY
ICD–10–CM ......................................
ICD–10–PCS ....................................
2012:
ICD–10–CM ......................................
ICD–10–PCS ....................................
2013:
ICD–10–CM ......................................
ICD–10–PCS ....................................
2014:
ICD–10–CM ......................................
ICD–10–PCS ....................................
2015:
ICD–10–CM ......................................
ICD–10–PCS ....................................
2016:
ICD–10–CM ......................................
ICD–10–PCS ....................................
PCS codes should be created, based on
the partial code freeze criteria. The
public was to use the criteria as to
whether codes were needed to capture
new diagnoses or new technologies. If
the codes do not meet those criteria for
implementation during the partial code
freeze, consideration was to be given as
to whether the codes should be created
after the partial code freeze ends 1 year
after the implementation of ICD–10–
CM/PCS. We invited public comments
on any code requests discussed at the
September 23–24, 2014 and March 18–
19, 2015 Committee meetings for
implementation as part of the October 1,
2015 update. The deadline for
commenting on code proposals
discussed at the September 23–24, 2014
Committee meeting was November 21,
2014. The deadline for commenting on
code proposals discussed at the March
PO 00000
Frm 00086
Fmt 4701
Number
FY 2009:
ICD–10–CM ......................................
ICD–10–PCS ....................................
FY 2010:
ICD–10–CM ......................................
ICD–10–PCS ....................................
117
21
14,567
3,877
As mentioned earlier, the public is
provided the opportunity to comment
on any requests for new diagnosis or
procedure codes discussed at the ICD–
10 Coordination and Maintenance
Committee meeting. The public has
supported only a limited number of new
codes during the partial code freeze, as
can be seen by data shown above. We
have gone from creating several
hundred new codes each year to
creating only a limited number of new
ICD–9–CM and ICD–10 codes.
At the September 23–24, 2014 and
March 18–19, 2015 Committee
meetings, we discussed any requests we
had received for new ICD–10–CM
diagnosis and ICD–10–PCS procedure
codes that were to be implemented on
October 1, 2015. We did not discuss
ICD–9–CM codes. The public was given
the opportunity to comment on whether
or not new ICD–10–CM and ICD–10–
VerDate Sep<11>2014
ICD–10–CM and ICD–10–PCS Codes
Sfmt 4702
Change
68,069
72,589
+5
¥14,327
69,099
71,957
+1,030
¥632
69,368
72,081
+269
+124
69,833
71,918
+465
¥163
69,832
71,920
¥1
+2
69,823
71,924
¥9
+4
69,823
71,924
0
0
69,823
71,962
0
+38
18–19, 2015 Committee meeting was
April 17, 2015.
14. Other Proposed Policy Changes:
Replaced Devices Offered Without Cost
or With a Credit
a. Background
In the FY 2008 IPPS final rule with
comment period (72 FR 47246 through
47251), we discussed the topic of
Medicare payment for devices that are
replaced without cost or where credit
for a replaced device is furnished to the
hospital. We implemented a policy to
reduce a hospital’s IPPS payment for
certain MS–DRGs where the
implantation of a device that has been
recalled determined the base MS–DRG
assignment. We specified that if a
hospital received a credit for a recalled
device equal to 50 percent or more of
the cost of the device, we would reduce
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a hospital’s IPPS payment for those MS–
DRGs.
In the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51556 and 51557), we
clarified this policy to state that the
policy applies if the hospital received a
credit equal to 50 percent or more of the
cost of the replacement device and
issued instructions to hospitals
accordingly.
b. Request for Clarification on Policy
Relating to ‘‘Device-Dependent’’ MS–
DRGs
After publication of the FY 2015
IPPS/LTCH PPS final rule, we received
a request to clarify the list of ‘‘devicedependent’’ MS–DRGs subject to the
policy for payment under the IPPS for
replaced devices offered without cost or
with a credit. Specifically, a requestor
noted that ICD–9–CM procedure codes
that previously grouped to MS–DRGs
216 through 221 (Cardiac Valve & Other
Major Cardiothoracic Procedure with
and without Cardiac Catheterization,
with MCC, with CC, without CC/MCC,
respectively) and were subject to the
policy for payment under the IPPS as
‘‘device-dependent’’ MS–DRGs had
been reassigned to new MS–DRGs 266
and 267 (Endovascular Cardiac Valve
Replacement with MCC and without
MCC, respectively). The requestor
suggested that MS–DRGs 266 and 267
also should be considered ‘‘devicedependent’’ MS–DRGs and added to the
list of MS–DRGs subject to the IPPS
payment policy for replaced devices
offered without cost or with a credit.
As noted by the requestor, as final
policy for FY 2015, certain ICD–9–CM
procedure codes that previously
grouped to MS–DRGs 216 through 221,
which are on the list of MS–DRGs
subject to the policy for payment under
the IPPS for replaced devices offered
without cost or with a credit, were
reassigned to MS–DRGs 266 and 267.
We agree that MS–DRGs 266 and 267
should be included in the list of
‘‘device-dependent’’ MS–DRGs subject
to the IPPS policy. We generally map
new MS–DRGs onto the list when they
are formed from procedures previously
assigned to MS–DRGs that are already
on the list. Therefore, we are proposing
to add MS–DRGs 266 and 267 to the list
of ‘‘device dependent’’ MS–DRGs
subject to the policy for payment under
the IPPS for replaced devices offered
without cost or with a credit.
In addition, as discussed in section
II.G.4.e. of the preamble of this
proposed rule, for FY 2016, we are
proposing to delete MS–DRGs 237 and
238 (Major Cardiovascular Procedures
with MCC and without MCC,
respectively) and create new MS–DRGs
268 and 269 (Aortic and Heart Assist
24409
Procedures Except Pulsation Balloon
with MCC and without MCC,
respectively), as well as new MS–DRGs
270, 271, and 272 (Other Major
Cardiovascular Procedures with MCC,
with CC, and without CC/MCC,
respectively). Currently, MS–DRGs 237
and 238 are on the list of MS–DRGs
subject to the policy for payment under
the IPPS for replaced devices offered
without cost or with a credit. As stated
previously, we generally map new MS–
DRGs onto the list when they are formed
from procedures previously assigned to
MS–DRGs that are already on the list.
Therefore, if finalized, we also would
add proposed new MS–DRGs 268
through 272 to the list of MS–DRGs
subject to the policy for payment under
the IPPS for replaced devices offered
without cost or with a credit.
In summary, we are proposing to add
MS–DRGs 266 and 267 to the list of
MS–DRGs subject to the policy for
payment under the IPPS for replaced
devices offered without cost or with a
credit, and if the applicable proposed
MS–DRG changes are finalized, to also
remove existing MS–DRGs 237 and 238
and add proposed new MS–DRGs 268
through 272. The proposed list of MS–
DRGs to be subject to the IPPS policy for
replaced devices offered without cost or
with a credit for FY 2016 is displayed
below.
PROPOSED LIST OF MS–DRGS SUBJECT TO THE IPPS POLICY FOR REPLACED DEVICES OFFERED WITHOUT COST OR
WITH A CREDIT
tkelley on DSK3SPTVN1PROD with PROPOSALS2
MDC
MS–
DRG
PreMDC .......
PreMDC .......
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 01 ........
MDC 03 ........
MDC 03 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
MDC 05 ........
001
002
023
024
025
026
027
040
041
042
129
130
215
216
217
218
219
220
221
222
223
224
225
226
227
242
243
244
245
258
VerDate Sep<11>2014
MS–DRG Title
Heart Transplant or Implant of Heart Assist System with MCC.
Heart Transplant or Implant of Heart Assist System without MCC.
Craniotomy with Major Device Implant/Acute Complex CNS PDX with MCC or Chemo Implant.
Craniotomy with Major Device Implant/Acute Complex CNS PDX without MCC.
Craniotomy & Endovascular Intracranial Procedures with MCC.
Craniotomy & Endovascular Intracranial Procedures with CC.
Craniotomy & Endovascular Intracranial Procedures without CC/MCC.
Peripheral/Cranial Nerve & Other Nervous System Procedures with MCC.
Peripheral/Cranial Nerve & Other Nervous System Procedures with CC or Peripheral Neurostimulation.
Peripheral/Cranial Nerve & Other Nervous System Procedures without CC/MCC.
Major Head & Neck Procedures with CC/MCC or Major Device.
Major Head & Neck Procedures without CC/MCC.
Other Heart Assist System Implant.
Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with MCC.
Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with CC.
Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization without CC/MCC.
Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC.
Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with CC.
Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization without CC/MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/HF/Shock with MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/HF/Shock without MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/HF/Shock with MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/HF/Shock without MCC.
Cardiac Defibrillator Implant without Cardiac Catheterization with MCC.
Cardiac Defibrillator Implant without Cardiac Catheterization without MCC.
Permanent Cardiac Pacemaker Implant with MCC.
Permanent Cardiac Pacemaker Implant with CC.
Permanent Cardiac Pacemaker Implant without CC/MCC.
AICD Generator Procedures.
Cardiac Pacemaker Device Replacement with MCC.
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PROPOSED LIST OF MS–DRGS SUBJECT TO THE IPPS POLICY FOR REPLACED DEVICES OFFERED WITHOUT COST OR
WITH A CREDIT—Continued
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
MDC
05
05
05
05
05
05
05
05
05
05
05
05
08
08
08
08
08
08
08
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
MS–
DRG
259
260
261
262
265
266
267
268
269
270
271
272
461
462
466
467
468
469
470
MS–DRG Title
Cardiac Pacemaker Device Replacement without MCC.
Cardiac Pacemaker Revision Except Device Replacement with MCC.
Cardiac Pacemaker Revision Except Device Replacement with CC.
Cardiac Pacemaker Revision Except Device Replacement without CC/MCC.
AICD Lead Procedures.
Endovascular Cardiac Valve Replacement with MCC.
Endovascular Cardiac Valve Replacement without MCC.
Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC.
Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC.
Other Major Cardiovascular Procedures with MCC.
Other Major Cardiovascular Procedures with CC.
Other Major Cardiovascular Procedures without CC/MCC.
Bilateral or Multiple Major Joint Procedures of Lower Extremity with MCC.
Bilateral or Multiple Major Joint Procedures of Lower Extremity without MCC.
Revision of Hip or Knee Replacement with MCC.
Revision of Hip or Knee Replacement with CC.
Revision of Hip or Knee Replacement without CC/MCC.
Major Joint Replacement or Reattachment of Lower Extremity with MCC.
Major Joint Replacement or Reattachment of Lower Extremity without MCC.
We are inviting public comments on
our proposed list of MS–DRGs to be
subject to the IPPS policy for replaced
devices offered without cost or with a
credit for FY 2016. The final list will be
included in the FY 2016 IPPS/LTCH
PPS final rule and also will be issued to
providers in the form of a Change
Request (CR).
tkelley on DSK3SPTVN1PROD with PROPOSALS2
H. Recalibration of the Proposed FY
2016 MS–DRG Relative Weights
1. Data Sources for Developing the
Relative Weights
In developing the proposed FY 2016
system of weights, we used two data
sources: Claims data and cost report
data. As in previous years, the claims
data source is the MedPAR file. This file
is based on fully coded diagnostic and
procedure data for all Medicare
inpatient hospital bills. The FY 2014
MedPAR data used in this proposed rule
include discharges occurring on October
1, 2013, through September 30, 2014,
based on bills received by CMS through
December 31, 2014, from all hospitals
subject to the IPPS and short-term, acute
care hospitals in Maryland (which at
that time were under a waiver from the
IPPS). The FY 2014 MedPAR file used
in calculating the proposed relative
weights includes data for approximately
9,638,230 Medicare discharges from
IPPS providers. Discharges for Medicare
beneficiaries enrolled in a Medicare
Advantage managed care plan are
excluded from this analysis. These
discharges are excluded when the
MedPAR ‘‘GHO Paid’’ indicator field on
the claim record is equal to ‘‘1’’ or when
the MedPAR DRG payment field, which
represents the total payment for the
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18:20 Apr 29, 2015
Jkt 235001
claim, is equal to the MedPAR ‘‘Indirect
Medical Education (IME)’’ payment
field, indicating that the claim was an
‘‘IME only’’ claim submitted by a
teaching hospital on behalf of a
beneficiary enrolled in a Medicare
Advantage managed care plan. In
addition, the December 31, 2014 update
of the FY 2014 MedPAR file complies
with version 5010 of the X12 HIPAA
Transaction and Code Set Standards,
and includes a variable called ‘‘claim
type.’’ Claim type ‘‘60’’ indicates that
the claim was an inpatient claim paid as
fee-for-service. Claim types ‘‘61,’’ ‘‘62,’’
‘‘63,’’ and ‘‘64’’ relate to encounter
claims, Medicare Advantage IME
claims, and HMO no-pay claims.
Therefore, the calculation of the
proposed relative weights for FY 2016
also excludes claims with claim type
values not equal to ‘‘60.’’ The data
exclude CAHs, including hospitals that
subsequently became CAHs after the
period from which the data were taken.
We note that the proposed FY 2016
relative weights are based on the ICD–
9–CM diagnoses and procedures codes
from the MedPAR claims data, grouped
through the ICD–9–CM version of the
FY 2016 GROUPER (Version 33). The
second data source used in the costbased relative weighting methodology is
the Medicare cost report data files from
the HCRIS. Normally, we use the HCRIS
dataset that is 3 years prior to the IPPS
fiscal year. Specifically, we used cost
report data from the December 31, 2014
update of the FY 2013 HCRIS for
calculating the proposed FY 2016 costbased relative weights.
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2. Methodology for Calculation of the
Proposed Relative Weights
As we explain in section II.E.3. of the
preamble of this proposed rule, we
calculated the FY 2016 relative weights
based on 19 CCRs, as we did for FY
2015. The methodology we used to
calculate the proposed FY 2016 MS–
DRG cost-based relative weights based
on claims data in the FY 2014 MedPAR
file and data from the FY 2013 Medicare
cost reports is as follows:
• To the extent possible, all the
claims were regrouped using the
proposed FY 2016 MS–DRG
classifications discussed in sections II.B.
and II.G. of the preamble of this
proposed rule.
• The transplant cases that were used
to establish the relative weights for heart
and heart-lung, liver and/or intestinal,
and lung transplants (MS–DRGs 001,
002, 005, 006, and 007, respectively)
were limited to those Medicareapproved transplant centers that have
cases in the FY 2014 MedPAR file.
(Medicare coverage for heart, heart-lung,
liver and/or intestinal, and lung
transplants is limited to those facilities
that have received approval from CMS
as transplant centers.)
• Organ acquisition costs for kidney,
heart, heart-lung, liver, lung, pancreas,
and intestinal (or multivisceral organs)
transplants continue to be paid on a
reasonable cost basis. Because these
acquisition costs are paid separately
from the prospective payment rate, it is
necessary to subtract the acquisition
charges from the total charges on each
transplant bill that showed acquisition
charges before computing the average
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cost for each MS–DRG and before
eliminating statistical outliers.
• Claims with total charges or total
lengths of stay less than or equal to zero
were deleted. Claims that had an
amount in the total charge field that
differed by more than $10.00 from the
sum of the routine day charges,
intensive care charges, pharmacy
charges, special equipment charges,
therapy services charges, operating
room charges, cardiology charges,
laboratory charges, radiology charges,
other service charges, labor and delivery
charges, inhalation therapy charges,
emergency room charges, blood charges,
and anesthesia charges were also
deleted.
• At least 92.1 percent of the
providers in the MedPAR file had
charges for 14 of the 19 cost centers. All
claims of providers that did not have
charges greater than zero for at least 14
of the 19 cost centers were deleted. In
other words, a provider must have no
more than five blank cost centers. If a
provider did not have charges greater
than zero in more than five cost centers,
the claims for the provider were deleted.
(We refer readers to the FY 2015 IPPS/
LTCH PPS final rule (79 FR 49911) for
the edit threshold related to FY 2015.)
• Statistical outliers were eliminated
by removing all cases that were beyond
3.0 standard deviations from the
geometric mean of the log distribution
of both the total charges per case and
the total charges per day for each MS–
DRG.
• Effective October 1, 2008, because
hospital inpatient claims include a POA
indicator field for each diagnosis
present on the claim, only for purposes
of relative weight-setting, the POA
indicator field was reset to ‘‘Y’’ for
‘‘Yes’’ for all claims that otherwise have
an ‘‘N’’ (No) or a ‘‘U’’ (documentation
insufficient to determine if the
condition was present at the time of
inpatient admission) in the POA field.
Under current payment policy, the
presence of specific HAC codes, as
indicated by the POA field values, can
generate a lower payment for the claim.
Specifically, if the particular condition
is present on admission (that is, a ‘‘Y’’
indicator is associated with the
diagnosis on the claim), it is not a HAC,
and the hospital is paid for the higher
severity (and, therefore, the higher
weighted MS–DRG). If the particular
condition is not present on admission
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(that is, an ‘‘N’’ indicator is associated
with the diagnosis on the claim) and
there are no other complicating
conditions, the DRG GROUPER assigns
the claim to a lower severity (and,
therefore, the lower weighted MS–DRG)
as a penalty for allowing a Medicare
inpatient to contract a HAC. While the
POA reporting meets policy goals of
encouraging quality care and generates
program savings, it presents an issue for
the relative weight-setting process.
Because cases identified as HACs are
likely to be more complex than similar
cases that are not identified as HACs,
the charges associated with HAC cases
are likely to be higher as well.
Therefore, if the higher charges of these
HAC claims are grouped into lower
severity MS–DRGs prior to the relative
weight-setting process, the relative
weights of these particular MS–DRGs
would become artificially inflated,
potentially skewing the relative weights.
In addition, we want to protect the
integrity of the budget neutrality process
by ensuring that, in estimating
payments, no increase to the
standardized amount occurs as a result
of lower overall payments in a previous
year that stem from using weights and
case-mix that are based on lower
severity MS–DRG assignments. If this
would occur, the anticipated cost
savings from the HAC policy would be
lost.
To avoid these problems, we reset the
POA indicator field to ‘‘Y’’ only for
relative weight-setting purposes for all
claims that otherwise have an ‘‘N’’ or a
‘‘U’’ in the POA field. This resetting
‘‘forced’’ the more costly HAC claims
into the higher severity MS–DRGs as
appropriate, and the relative weights
calculated for each MS–DRG more
closely reflect the true costs of those
cases.
In addition, in the FY 2013 IPPS/
LTCH PPS final rule, for FY 2013 and
subsequent fiscal years, we finalized a
policy to treat hospitals that participate
in the Bundled Payments for Care
Improvement (BPCI) initiative the same
as prior fiscal years for the IPPS
payment modeling and ratesetting
process without regard to hospitals’
participation within these bundled
payment models (that is, as if hospitals
were not participating in those models
under the BPCI initiative). The BPCI
initiative, developed under the
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24411
authority of section 3021 of the
Affordable Care Act (codified at section
1115A of the Act), is comprised of four
broadly defined models of care, which
link payments for multiple services
beneficiaries receive during an episode
of care. Under the BPCI initiative,
organizations enter into payment
arrangements that include financial and
performance accountability for episodes
of care. For FY 2016, we are proposing
to continue to include all applicable
data from subsection (d) hospitals
participating in BPCI Models 1, 2, and
4 in our IPPS payment modeling and
ratesetting calculations. We refer readers
to the FY 2013 IPPS/LTCH PPS final
rule for a complete discussion on our
final policy for the treatment of
hospitals participating in the BPCI
initiative in our ratesetting process. For
additional information on the BPCI
initiative, we refer readers to the CMS’
Center for Medicare and Medicaid
Innovation’s Web site at: https://
innovation.cms.gov/initiatives/BundledPayments/ and to section
IV.H.4. of the preamble of the FY 2013
IPPS/LTCH PPS final rule (77 FR 53341
through 53343).
Once the MedPAR data were trimmed
and the statistical outliers were
removed, the charges for each of the 19
cost groups for each claim were
standardized to remove the effects of
differences in area wage levels, IME and
DSH payments, and for hospitals
located in Alaska and Hawaii, the
applicable cost-of-living adjustment.
Because hospital charges include
charges for both operating and capital
costs, we standardized total charges to
remove the effects of differences in
geographic adjustment factors, cost-ofliving adjustments, and DSH payments
under the capital IPPS as well. Charges
were then summed by MS–DRG for each
of the 19 cost groups so that each MS–
DRG had 19 standardized charge totals.
These charges were then adjusted to
cost by applying the national average
CCRs developed from the FY 2013 cost
report data.
The 19 cost centers that we used in
the proposed relative weight calculation
are shown in the following table. The
table shows the lines on the cost report
and the corresponding revenue codes
that we used to create the 19 national
cost center CCRs.
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Cost center
group name
(19 total)
MedPAR charge
field
Revenue codes
contained in
MedPAR
charge field
Cost from
HCRIS
(Worksheet C,
Part 1,
Column 5
and line
number)
Form
CMS–2552–10
Charges from
HCRIS
(Worksheet C,
Part 1,
Column 6 & 7
and line
number)
Form
CMS–2552–10
Medicare
charges from
HCRIS
(Worksheet D–3,
Column & line
number)
Form
CMS–2552–10
Adults & Pediatrics
(General Routine
Care).
................................
C_1_C5_30 .......
C_1_C6_30 .......
D3_HOS_C2_30
...........................
...........................
Cost report
line description
Routine Days .........
Private Room
Charges.
011X and 014X ......
Intensive Days .......
Semi–Private Room
Charges.
Ward Charges ........
Intensive Care
Charges.
Coronary Care
Charges.
012X, 013X and
016X–019X.
015X ......................
020X ......................
................................
Intensive Care Unit
...........................
C_1_C5_31 .......
...........................
C_1_C6_31 .......
D3_HOS_C2_31
021X ......................
Coronary Care Unit
C_1_C5_32 .......
C_1_C6_32 .......
D3_HOS_C2_32
C_1_C5_33 .......
C_1_C6_33 .......
D3_HOS_C2_33
C_1_C5_34 .......
C_1_C6_34 .......
D3_HOS_C2_34
C_1_C5_35 .......
C_1_C6_35 .......
D3_HOS_C2_35
025X, 026X and
063X.
Burn Intensive Care
Unit.
Surgical Intensive
Care Unit.
Other Special Care
Unit.
Intravenous Therapy.
Drugs Charged To
Patient.
Medical Supplies
Charged to Patients.
C_1_C5_64 .......
C_1_C6_64 .......
C_1_C7_64
C_1_C6_73 .......
C_1_C7_73
C_1_C6_71 .......
C_1_C7_71
D3_HOS_C2_64
C_1_C5_96 .......
C_1_C6_96 .......
C_1_C7_96
D3_HOS_C2_96
C_1_C6_97 .......
C_1_C7_97
C_1_C6_72 .......
C_1_C7_72
D3_HOS_C2_97
C_1_C6_66
C_1_C7_66
C_1_C6_67
C_1_C7_67
C_1_C6_68
C_1_C7_68
C_1_C6_65
C_1_C7_65
C_1_C6_50
C_1_C7_50
C_1_C6_51
C_1_C7_51
C_1_C6_52
C_1_C7_52
C_1_C6_53
C_1_C7_53
C_1_C6_69
C_1_C7_69
C_1_C6_59
C_1_C7_59
C_1_C6_60
C_1_C7_60
C_1_C6_61
C_1_C7_61
C_1_C6_70
C_1_C7_70
C_1_C6_54
C_1_C7_54
C_1_C6_55
.......
D3_HOS_C2_66
.......
D3_HOS_C2_67
.......
D3_HOS_C2_68
.......
D3_HOS_C2_65
.......
D3_HOS_C2_50
.......
D3_HOS_C2_51
.......
D3_HOS_C2_52
.......
D3_HOS_C2_53
.......
D3_HOS_C2_69
.......
D3_HOS_C2_59
.......
D3_HOS_C2_60
.......
D3_HOS_C2_61
.......
D3_HOS_C2_70
.......
D3_HOS_C2_54
.......
D3_HOS_C2_55
C_1_C6_56 .......
C_1_C7_56
C_1_C6_57 .......
C_1_C7_57
D3_HOS_C2_56
Drugs .....................
Supplies and Equipment.
Pharmacy Charges
Medical/Surgical
Supply Charges.
Durable Medical
Equipment
Charges.
Used Durable Medical Charges.
Inhalation Therapy
C_1_C5_71 .......
Physical Therapy
Charges.
Occupational Therapy Charges.
Speech Pathology
Charges.
Inhalation Therapy
Charges.
Operating Room
Charges.
0293 .......................
DME–Sold ..............
C_1_C5_97 .......
0275, 0276, 0278,
0624.
Implantable Devices
Therapy Services ...
0270, 0271, 0272,
0273, 0274,
0277, 0279, and
0621, 0622, 0623.
0290, 0291, 0292
DME–Rented .........
and 0294–0299.
C_1_C5_73 .......
Implantable Devices
Charged to Patients.
Physical Therapy ...
C_1_C5_72 .......
042X ......................
043X ......................
044X and 047X ......
C_1_C5_67 .......
C_1_C5_68 .......
036X ......................
Respiratory Therapy.
Operating Room ....
C_1_C5_50 .......
071X ......................
Recovery Room .....
C_1_C5_51 .......
072X ......................
037X ......................
Delivery Room and
Labor Room.
Anesthesiology ......
C_1_C5_52 .......
Anesthesia .............
Operating Room
Charges.
Anesthesia Charges
C_1_C5_53 .......
Cardiology ..............
Cardiology Charges
048X and 073X ......
Electro-cardiology ..
C_1_C5_69 .......
0481 .......................
Cardiac Catheterization.
Laboratory ..............
C_1_C5_59 .......
Operating Room ....
Labor & Delivery ....
Cardiac Catheterization.
Laboratory ..............
Laboratory Charges
041X and 046X ......
Occupational Therapy.
Speech Pathology
C_1_C5_66 .......
030X, 031X, and
075X.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
074X, 086X ............
Radiology ...............
Radiology Charges
032X, 040X ............
028X, 0331, 0332,
0333, 0335,
0339, 0342.
0343 and 344 ........
Computed Tomography (CT) Scan.
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035X ......................
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PBP Clinic Laboratory Services.
Electro-Encephalography.
Radiology—Diagnostic.
Radiology—Therapeutic.
C_1_C5_65 .......
C_1_C5_60 .......
C_1_C5_61 .......
C_1_C5_70 .......
C_1_C5_54 .......
C_1_C5_55 .......
Radioisotope ..........
C_1_C5_56 .......
Computed Tomography (CT) Scan.
C_1_C5_57 .......
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Cost center
group name
(19 total)
MedPAR charge
field
Revenue codes
contained in
MedPAR
charge field
Magnetic Resonance Imaging
(MRI).
Emergency Room ..
MRI Charges ..........
061X ......................
Emergency Room
Charges.
Blood Charges .......
045X ......................
Cost report
line description
Magnetic Resonance Imaging
(MRI).
Emergency .............
24413
Cost from
HCRIS
(Worksheet C,
Part 1,
Column 5
and line
number)
Form
CMS–2552–10
Charges from
HCRIS
(Worksheet C,
Part 1,
Column 6 & 7
and line
number)
Form
CMS–2552–10
Medicare
charges from
HCRIS
(Worksheet D–3,
Column & line
number)
Form
CMS–2552–10
C_1_C5_58 .......
C_1_C6_58 .......
C_1_C7_58
D3_HOS_C2_58
C_1_C5_91 .......
D3_HOS_C2_91
Other Services .......
039X ......................
D3_HOS_C2_63
Other Service
Charge.
0002–0099, 022X,
023X,
024X,052X,053X.
055X–060X, 064X–
070X, 076X–
078X, 090X–
095X and 099X.
0800X ....................
080X and 082X–
088X.
Renal Dialysis ........
ESRD Revenue
Setting Charges.
Outpatient Service
Charges.
Lithotripsy Charge ..
Clinic Visit Charges
Professional Fees
Charges.
Ambulance
Charges.
049X ......................
079X ......................
051X ......................
096X, 097X, and
098X.
054X ......................
We refer readers to the FY 2009 IPPS/
LTCH PPS final rule (73 FR 48462) for
a discussion on the revenue codes
included in the Supplies and
Equipment and Implantable Devices
CCRs, respectively.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
3. Development of National Average
CCRs
We developed the national average
CCRs as follows:
Using the FY 2013 cost report data,
we removed CAHs, Indian Health
Service hospitals, all-inclusive rate
hospitals, and cost reports that
represented time periods of less than 1
year (365 days). We included hospitals
located in Maryland because we include
their charges in our claims database. We
then created CCRs for each provider for
each cost center (see prior table for line
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C_1_C5_63 .......
C_1_C6_63 .......
C_1_C7_63
...........................
...........................
................................
...........................
...........................
Renal Dialysis ........
................................
C_1_C5_74 .......
...........................
C_1_C6_74 .......
C_1_C7_74
D3_HOS_C2_74
Home Program Dialysis.
ASC (Non Distinct
Part).
................................
Other Ancillary .......
C_1_C5_94 .......
C_1_C6_94 .......
C_1_C7_94
C_1_C6_75 .......
D3_HOS_C2_94
...........................
C_1_C5_76 .......
Clinic ......................
C_1_C5_90 .......
C_1_C5_92.01 ..
Other Outpatient
Services.
Ambulance .............
C_1_C5_93 .......
C_1_C5_95 .......
C_1_C5_88 .......
FQHC .....................
Blood Storage/Processing.
C_1_C5_62 .......
Rural Health Clinic
038X ......................
Whole Blood &
Packed Red
Blood Cells.
Blood Storing, Processing, &
Transfusing.
................................
Observation beds ...
Blood and Blood
Products.
C_1_C6_91 .......
C_1_C7_91
C_1_C6_62 .......
C_1_C7_62
C_1_C5_89 .......
C_1_C5_75 .......
items used in the calculations) and
removed any CCRs that were greater
than 10 or less than 0.01. We
normalized the departmental CCRs by
dividing the CCR for each department
by the total CCR for the hospital for the
purpose of trimming the data. We then
took the logs of the normalized cost
center CCRs and removed any cost
center CCRs where the log of the cost
center CCR was greater or less than the
mean log plus/minus 3 times the
standard deviation for the log of that
cost center CCR. Once the cost report
data were trimmed, we calculated a
Medicare-specific CCR. The Medicarespecific CCR was determined by taking
the Medicare charges for each line item
from Worksheet D–3 and deriving the
Medicare-specific costs by applying the
hospital-specific departmental CCRs to
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C_1_C7_75
C_1_C6_76 .......
C_1_C7_76
C_1_C6_90 .......
C_1_C7_90
C_1_C6_92.01 ..
C_1_C7_92.01
C_1_C6_93 .......
C_1_C7_93
C_1_C6_95 .......
C_1_C7_95
C_1_C6_88 .......
C_1_C7_88
C_1_C6_89 .......
C_1_C7_89
D3_HOS_C2_62
D3_HOS_C2_75
D3_HOS_C2_76
D3_HOS_C2_90
D3_HOS_C2_
92.01
D3_HOS_C2_93
D3_HOS_C2_95
D3_HOS_C2_88
D3_HOS_C2_89
the Medicare-specific charges for each
line item from Worksheet D–3. Once
each hospital’s Medicare-specific costs
were established, we summed the total
Medicare-specific costs and divided by
the sum of the total Medicare-specific
charges to produce national average,
charge-weighted CCRs.
After we multiplied the total charges
for each MS–DRG in each of the 19 cost
centers by the corresponding national
average CCR, we summed the 19 ‘‘costs’’
across each MS–DRG to produce a total
standardized cost for the MS–DRG. The
average standardized cost for each MS–
DRG was then computed as the total
standardized cost for the MS–DRG
divided by the transfer-adjusted case
count for the MS–DRG. The average cost
for each MS–DRG was then divided by
the national average standardized cost
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per case to determine the relative
weight.
The proposed FY 2016 cost-based
relative weights were then normalized
by an adjustment factor of 1.678672 so
that the average case weight after
recalibration was equal to the average
case weight before recalibration. The
normalization adjustment is intended to
ensure that recalibration by itself
neither increases nor decreases total
payments under the IPPS, as required by
section 1886(d)(4)(C)(iii) of the Act.
The proposed 19 national average
CCRs for FY 2016 are as follows:
Group
Routine Days ....................................
Intensive Days ..................................
Drugs ................................................
Supplies & Equipment ......................
Implantable Devices .........................
Therapy Services ..............................
Laboratory .........................................
Operating Room ...............................
Cardiology .........................................
Cardiac Catheterization ....................
Radiology ..........................................
MRIs .................................................
CT Scans ..........................................
Emergency Room .............................
Blood and Blood Products ................
Other Services ..................................
Labor & Delivery ...............................
Group
Inhalation Therapy ............................
Anesthesia ........................................
0.178
0.108
Since FY 2009, the relative weights
have been based on 100 percent cost
weights based on our MS–DRG grouping
system.
When we recalibrated the DRG
weights for previous years, we set a
threshold of 10 cases as the minimum
number of cases required to compute a
reasonable weight. For FY 2016, we are
proposing to use that same case
threshold in recalibrating the MS–DRG
CCR
relative weights for FY 2016. Using data
from the FY 2014 MedPAR file, there
0.485 were 8 MS–DRGs that contain fewer
0.399
than 10 cases. Under the MS–DRGs, we
0.192
0.299 have fewer low-volume DRGs than
0.344 under the CMS DRGs because we no
0.335 longer have separate DRGs for patients
0.125 aged 0 to 17 years. With the exception
0.201 of newborns, we previously separated
0.119 some DRGs based on whether the
0.125 patient was age 0 to 17 years or age 17
0.159 years and older. Other than the age split,
0.085
cases grouping to these DRGs are
0.041
0.184 identical. The DRGs for patients aged 0
0.340 to 17 years generally have very low
0.367 volumes because children are typically
0.404 ineligible for Medicare. In the past, we
Low-volume
MS–DRG
MS–DRG Title
768 ...............
791 ...............
Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C.
Neonates, Died or Transferred to Another
Acute Care Facility.
Extreme Immaturity or Respiratory Distress Syndrome, Neonate.
Prematurity with Major Problems ..............
792 ...............
Prematurity without Major Problems .........
793 ...............
Full-Term Neonate with Major Problems ..
794 ...............
Neonate with Other Significant Problems
795 ...............
Normal Newborn .......................................
789 ...............
790 ...............
We are inviting public comments on
this proposal.
4. Solicitation of Public Comments on
Expanding the Bundled Payments for
Care Improvement (BPCI) Initiative
tkelley on DSK3SPTVN1PROD with PROPOSALS2
CCR
a. Background
Since 2011, CMS has been working to
develop and test models of bundling
Medicare payments under the authority
of section 1115A of the Act. Through
these models, CMS plans to evaluate
whether bundled payments result in
higher quality and more coordinated
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have found that the low volume of cases
for the pediatric DRGs could lead to
significant year-to-year instability in
their relative weights. Although we have
always encouraged non-Medicare payers
to develop weights applicable to their
own patient populations, we have
received frequent complaints from
providers about the use of the Medicare
relative weights in the pediatric
population. We believe that eliminating
this age split in the MS–DRGs will
provide more stable payment for
pediatric cases by determining their
payment using adult cases that are
much higher in total volume. Newborns
are unique and require separate MS–
DRGs that are not mirrored in the adult
population. Therefore, it remains
necessary to retain separate MS–DRGs
for newborns. All of the low-volume
MS–DRGs listed below are for
newborns. For FY 2016, because we do
not have sufficient MedPAR data to set
accurate and stable cost relative weights
for these low-volume MS–DRGs, we are
proposing to compute relative weights
for the low-volume MS–DRGs by
adjusting their final FY 2015 relative
weights by the percentage change in the
average weight of the cases in other MS–
DRGs. The crosswalk table is shown
below:
Crosswalk to MS–DRG
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
Final FY 2015 relative weight
cases in other MS DRGs).
Final FY 2015 relative weight
cases in other MS-DRGs).
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
(adjusted by percent change in average weight of the
care at a lower cost to Medicare. CMS
is currently testing the Bundled
Payments for Care Improvement (BPCI)
initiative. Under this initiative,
organizations enter into payment
arrangements that include financial and
performance accountability for episodes
of care.
The BPCI initiative is comprised of
four related payment models, which
link payments for multiple services that
Medicare beneficiaries receive during an
episode of care into a bundled payment.
Episodes of care under the BPCI
initiative begin with either (1) an
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inpatient hospital stay or (2) postacute
care services following a qualifying
inpatient hospital stay. More
information on the four models under
the BPCI initiative can be found on the
CMS Center for Medicare and Medicaid
Innovation’s Web site at: https://
innovation.cms.gov/initiatives/bundledpayments/. We also have included
discussions of the BPCI initiative in the
annual IPPS/LTCH PPS rulemakings
since FY 2013 (77 FR 53341 through
53343).
All four models in the BPCI initiative
pay a discounted bundled payment for
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a single episode of care as an alternative
approach to payment for service
delivery under traditional Medicare feefor-service (FFS). Model 1 participants
are paid a discounted bundled payment
in lieu of the standard IPPS payment
upon submission of claims. In Models 2
and 3, the bundled payment is paid
retrospectively through a reconciliation
process; participants continue to submit
claims and receive payment via the
usual Medicare FFS payment systems.
In Model 4, the bundled payment is
made prospectively to a hospital, and
participating physician and
nonphysician practitioners submit ‘‘nopay’’ claims to CMS. In all models,
participants in the BPCI initiative are
permitted to share gains arising from the
providers’ care redesign efforts under
certain circumstances in which such
arrangements would not otherwise be
permitted under Medicare.
Each of the four models in the BPCI
initiative tests bundled payments for a
different episode of care:
• Model 1 tests retrospective bundled
payments for the acute care hospital
stay only. All participants in this model
are acute care hospitals, and the episode
of care is defined as the inpatient stay
in the acute care hospital. The hospital
is paid a discounted amount based on
the payment rates established under the
IPPS used in the original Medicare
program. Physicians are paid separately
for their services under the Medicare
Physician Fee Schedule (MPFS).
While Model 1 makes payments as
described above for all MS–DRGs,
Models 2, 3, and 4 of the BPCI initiative
test 48 episodes (comprised of
groupings of related MS–DRGs). These
episodes and the groupings of related
MS–DRGs that are included in these
episodes are listed in the table below.
• In Model 2, the episode of care
includes the inpatient stay in an acute
care hospital and all related services
during the episode, including postacute
care services. The episode ends either
30, 60, or 90 days after a hospital
discharge.
• Model 3 focuses on postacute care
services. In this model, the episode of
care is triggered by an acute care
hospital stay for an MS–DRG included
in the episode and begins at the
initiation of postacute care services in a
skilled nursing facility (SNF), inpatient
rehabilitation facility (IRF), long-term
care hospital (LTCH), or home health
agency (HHA). The episode includes
postacute care services, physicians’
services, and related services provided
during an inpatient hospital
readmission, but does not include
services provided during the episodeinitiating acute care hospital stay. The
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postacute care services included in the
episode must begin within 30 days of
discharge from the inpatient hospital
stay and may end either 30, 60, or 90
days after the initiation of the episode.
• Model 4 tests prospective single
bundled payments for physicians’
services and hospital services furnished
during an acute care hospitalization and
related readmissions. Under this model,
a single, prospectively determined
bundled payment is made to the
participating hospital that encompasses
all services furnished during the
inpatient stay by the hospital,
physicians, and other practitioners.
Payments for services furnished in
related readmissions for 30 days after
the hospital discharge are included in
the bundled payment amount.
Model 1 of the BPCI initiative began
in April 2013. CMS has allowed for
participation in two phases in Models 2,
3, and 4. The first phase is the
preparatory phase. In the preparatory
phase, participants in the BPCI initiative
are provided claims data so that they
may analyze patterns of care for
episodes in preparation for improving
care coordination and quality under
bundled payments prior to participation
in the second phase, the risk-bearing
phase.
In the BPCI initiative, the term ‘‘riskbearing’’ refers to the requirement that
certain participants in the BPCI
initiative bear financial risk for
spending above the target price set by
Medicare across the episodes of care in
which they participate. By using this
term, we do not connote any
relationship to insurance; we narrowly
define this term and use it only to
highlight the following financial
responsibilities: In the risk-bearing
phase, awardees and awardee conveners
in Models 2 and 3 are financially
responsible to Medicare if FFS
expenditures are higher than a target
price established by Medicare for the
episode(s) in which they are
participating. Awardees assume risk on
behalf of themselves; awardee
conveners assume risk on behalf of
others and, in some cases, themselves
(as described below). Medicare will
recoup the difference between the target
price and the actual FFS expenditures
from awardees and awardee conveners
for all services included in the episode
of care if the target price is exceeded.
Medicare will pay awardees and
awardee conveners the difference if
actual FFS expenditures are below the
target price. Awardees and awardee
conveners in Model 4 who have
assumed risk on behalf of themselves
and/or others bear risk in that they
assume financial responsibility if the
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bundled prospective payment from
Medicare does not cover the services
included in the episode of care.
Awardees and all participants under
awardee conveners in Models 2, 3, and
4 must move to the risk-bearing phase
by July 1, 2015.
There are several entity types
currently participating in the two
phases included in the BPCI initiative’s
Models 2, 3, and 4. Episode initiators,
defined as the entities that initiate
episodes of care in Models 2, 3, and 4,
are provided claims data in the
preparatory phase so that they may
establish a structure for bundled
payments prior to participation in the
risk-bearing phase of the initiative. The
entities that initiate episodes of care
vary by model: In Model 4, episode
initiators are acute care hospitals only;
in Model 2, episode initiators are acute
care hospitals and physician group
practices; and in Model 3, episode
initiators are SNFs, HHAs, LTCHs, IRFs,
and physician group practices.
To move into the risk-bearing phase,
participants must be selected by CMS
following a comprehensive review and
enter into an agreement with CMS. In
the risk-bearing phase, episode initiators
participate through one of two options.
The first option is that the episode
initiator may be an awardee and sign an
agreement directly with CMS containing
a risk-bearing financial arrangement.
While not required, risk-bearing episode
initiators may be associated with a
‘‘facilitator convener,’’ an entity that
convenes multiple health care providers
and supports the episode initiators in
implementing the BPCI initiative but
does not itself bear any risk.
Alternatively, through the second
option, the episode initiator may
participate in the BPCI initiative under
an awardee convener, which is an
organization that may or may not be a
Medicare provider that assumes
financial risk on behalf of the episode
initiator. In the second option, the
awardee convener signs an agreement
with CMS containing the terms of
participation in the model, including a
risk-bearing financial arrangement.
Participation through an awardee
convener allows episode initiators to
mitigate their financial risk, and
participation through an awardee or
facilitator convener allows episode
initiators to benefit in many cases from
the convener’s resources, such as
enhanced technology and
administrative assistance.
As of April 2015, the participation in
the risk-bearing phase of the BPCI
initiative is as follows: Model 2 is
testing 2,053 episodes among 345
episode initiators located in 45 States;
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Model 3 is testing 3,407 episodes among
318 episode initiators located in 29
States. Model 4 is testing 16 episodes
among 9 episode initiators located in 7
States. There are 49 facilitator conveners
and awardee conveners across the four
models. In addition to the entities in the
risk-bearing phase, several thousand
entities in the preparatory phase are still
considering whether to enter the
performance phase, upon successful
completion of screening and review by
CMS.
The episodes of care and the
associated MS–DRGs that define the
episodes that are being tested in Models
2, 3, and 4 of the BPCI initiative are
listed in the table below. This table is
based on FY 2015 IPPS MS–DRGs and
does not account yet for proposed FY
2016 changes to the MS–DRGs.
EPISODES OF CARE AND MS–DRG GROUPINGS UNDER THE BUNDLED PAYMENTS FOR CARE IMPROVEMENT INITIATIVE
FOR MODELS 2, 3, AND 4
Episode of care
MS–DRGs
Acute myocardial infarction .............................................................................................................
AICD generator or lead ...................................................................................................................
Amputation .......................................................................................................................................
280, 281, 282.
245, 265.
239, 240, 241, 255, 256, 257, 474, 475, 476,
616, 617, 618.
302, 303.
518, 519, 520.
231, 232, 233, 234, 235, 236.
308, 309, 310.
222, 223, 224, 225, 226, 227.
216, 217, 218, 219, 220, 221, 266, 267.
602, 603.
471, 472, 473.
313.
453, 454, 455.
456, 457, 458
291, 292, 293.
190, 191, 192, 202, 203.
637, 638, 639.
461, 462.
391, 392.
533, 534, 535, 536.
377, 378, 379.
388, 389, 390.
480, 481, 482.
492, 493, 494.
329, 330, 331.
237, 238.
469, 470.
483.
537, 538, 551, 552, 553, 554, 555, 556, 557,
558, 559, 560, 561, 562, 563.
299, 300, 301.
640, 641.
485, 486, 487, 488, 489.
189, 204, 205, 206, 207, 208, 186, 187, 188.
252, 253, 254.
242, 243, 244.
258, 259, 260, 261, 262.
246, 247, 248, 249, 250, 251.
811, 812.
495, 496, 497, 498, 499.
682, 683, 684.
466, 467, 468.
870, 871, 872.
177, 178, 179, 193, 194, 195.
459, 460.
61, 62, 63, 64, 65, 66.
312.
69.
689, 690.
Atherosclerosis ................................................................................................................................
Back and neck except spinal fusion ................................................................................................
Coronary artery bypass graft ...........................................................................................................
Cardiac arrhythmia ..........................................................................................................................
Cardiac defibrillator ..........................................................................................................................
Cardiac valve ...................................................................................................................................
Cellulitis ...........................................................................................................................................
Cervical spinal fusion ......................................................................................................................
Chest pain .......................................................................................................................................
Combined anterior posterior spinal fusion ......................................................................................
Complex noncervical spinal fusion ..................................................................................................
Congestive heart failure ..................................................................................................................
Chronic obstructive pulmonary disease, bronchitis, asthma ...........................................................
Diabetes ...........................................................................................................................................
Double joint replacement of the lower extremity .............................................................................
Esophagitis, gastroenteritis, and other digestive disorders ............................................................
Fractures of the femur and hip or pelvis .........................................................................................
Gastrointestinal hemorrhage ...........................................................................................................
Gastrointestinal obstruction .............................................................................................................
Hip and femur procedures except major joint .................................................................................
Lower extremity and humerus procedure except hip, foot, femur ..................................................
Major bowel procedures ..................................................................................................................
Major cardiovascular procedure ......................................................................................................
Major joint replacement of the lower extremity ...............................................................................
Major joint replacement of the upper extremity ..............................................................................
Medical noninfectious orthopedic ....................................................................................................
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Medical peripheral vascular disorders .............................................................................................
Nutritional and metabolic disorders .................................................................................................
Other knee procedures ....................................................................................................................
Other respiratory ..............................................................................................................................
Other vascular surgery ....................................................................................................................
Pacemaker .......................................................................................................................................
Pacemaker device replacement or revision ....................................................................................
Percutaneous coronary intervention ................................................................................................
Red blood cell disorders ..................................................................................................................
Removal of orthopedic devices .......................................................................................................
Renal failure ....................................................................................................................................
Revision of the hip or knee .............................................................................................................
Sepsis ..............................................................................................................................................
Simple pneumonia and respiratory infections .................................................................................
Spinal fusion (noncervical) ..............................................................................................................
Stroke ..............................................................................................................................................
Syncope and collapse .....................................................................................................................
Transient ischemia ..........................................................................................................................
Urinary tract infection ......................................................................................................................
b. Considerations for Potential Model
Expansion
In this FY 2016 IPPS/LTCH PPS
proposed rule, we are soliciting public
comments regarding policy and
operational issues related to a potential
expansion of the BPCI initiative in the
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future. Section 1115A(c) of the Act, as
added by section 3021 of the Affordable
Care Act, provides the Secretary with
the authority to expand through
rulemaking the duration and scope of a
model that is being tested under section
1115A(b) of the Act, such as the BPCI
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initiative (including implementation on
a nationwide basis), if the following
findings are made, taking into account
the evaluation of the model under
section 1115A(b)(4) of the Act: (1) The
Secretary determines that the expansion
is expected to either reduce Medicare
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spending without reducing the quality
of care or improve the quality of patient
care without increasing spending; (2)
the CMS Chief Actuary certifies that the
expansion would reduce (or would not
result in any increase in) net Medicare
program spending; and (3) the Secretary
determines that the expansion would
not deny or limit the coverage or
provision of Medicare benefits. The
decision of whether or not to expand
will be made by the Secretary in
coordination with CMS and the Office
of the Chief Actuary based on whether
findings about the initiative meet the
statutory criteria for expansion under
section 1115A(c) of the Act.
Evaluation of the BPCI initiative for
expansion is expected to include
analyses based on a combination of
qualitative and quantitative sources,
including Medicare claims, patient
surveys, awardee reports, interviews,
and site visits. Given that further
evaluation of the BPCI initiative is
needed to determine its impact on both
Medicare cost and quality of care, at this
time, we are not proposing an expansion
of any models within the initiative or
any policy changes associated with it.
Instead, we are requesting public
comments on issues surrounding a
potential expansion of the BPCI
initiative so that we can be prepared in
the event that the Secretary determines
that findings from the evaluation of the
initiative demonstrate that it meets all
criteria for expansion, consistent with
the requirements of section 1115A(c) of
the Act, and that, based on these
findings and other pertinent factors,
expansion is warranted.
CMS is committed to testing new
payment and service delivery models,
evaluating results and advancing best
practices, and engaging stakeholders.
These three priorities are crucial to the
BPCI initiative. As we initiate
discussions about potential expansion,
we continue to value stakeholder
engagement within the framework of
CMS’ priorities for the BPCI initiative.
Consistent with its ongoing commitment
to develop new models and refine
existing models based on additional
information and experience, CMS may
modify existing models or test
additional models under its testing
authority under section 1115A of the
Act. It may possibly do so, taking into
consideration stakeholder input,
including feedback received through the
public comments submitted in response
to the discussion in this section.
However, the primary goal for this
solicitation of public comments is to
receive information about a potential
expansion of the BPCI initiative.
Therefore, we are requesting that public
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comments on the discussion in this
section consider how expanded episode
payment could continue to encourage
high-quality, high-value care during
Medicare beneficiaries’ episodes of care,
while allowing for accurate payments to
providers, encouraging coordination of
care among providers, and ensuring
access to care and freedom of choice for
all Medicare beneficiaries, regardless of
their severity of illness. The following
list is not an exhaustive list of issues on
which we are requesting public
comments, and the inclusion of the list
of issues is not, in any way, meant to
imply that any or all of these issues
would be addressed in any expanded
model. The solicitation of public
comments is for planning purposes, and
as mentioned above, we would use
additional rulemaking if we decide to
expand any of the models.
We are seeking public comments on
the following issues:
• Breadth and scope of an expansion.
For example, whether model expansion
should focus on one or more of the four
models or one or more specific
episodes, or should target specific
geographic regions of the country.
Further, would the model best be
expanded with voluntary participation
or be most effective if participation were
required within the chosen models,
episodes, and regions.
• Episode definitions. We are seeking
public comments on the current BPCI
initiative episode definitions as part of
an expansion, including the MS–DRGs,
other bundled services (such as hospital
readmissions), exclusions, and the
duration of the episodes. The BPCI
initiative uses broadly defined episodes,
and these episodes include MS–DRGs
that account for approximately 80
percent of Medicare hospital discharges.
Depending on the model, lengths of
episodes may be 30, 60, or 90 days.
Under all models within the BPCI
initiative, these episode definitions have
been standardized across models for
episodes that relate to an acute care
hospital stay. An expansion might target
episodes beginning with inpatient
hospital care or postacute care. We are
seeking public comments regarding
whether episode definition refinements
should be made; for example,
refinements potentially could be made
for episodes that begin with postacute
care to incorporate the findings from
standardized patient assessments at
postacute care initiation, rather than
tying the episode to the hospital
discharge diagnosis.
• Models for expansion. We are
seeking public comments on whether
we should consider one or more of the
current BPCI initiative models as the
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first candidates for expansion. For
example, under a model expansion, we
potentially could expand several or all
of the models that include postacute
care on a similar timeframe or one
model at a time.
• Roles of organizations and
relationships necessary or beneficial to
care transformation. We are seeking
public comments on the roles that
organizations, including health care
providers and suppliers and other
entities, should serve under an
expanded model. Within this category,
we are seeking public comments
specifically on the types of relationships
and arrangements, financial or
otherwise, that would assist participants
with care transformation in an
expanded model. We would appreciate
any public comments on whether
relationships encouraged under an
expansion could have unintended
consequences and what those
consequences might be.
• Setting bundled payment amounts.
We are seeking public comments on
approaches to setting bundled payments
under model expansion. For
participants in the BPCI initiative,
bundled payments are related to the
historical episode experience of episode
initiators based on data from 2009
through 2012. In the BPCI initiative,
only Model 4 rates are set prospectively,
while Models 2 and 3 involve trending
of target amounts following the
conclusion of episodes. We potentially
could base payments on regional
episode experience or set all payments
prospectively under model expansion.
We potentially could apply the same
episode discount percentages to all
episodes or vary these discount
percentages based on care redesign
opportunity in the specific episode. We
potentially could rebase payments
annually or on another timeframe. In the
case of setting payment amounts via a
specified discount percentage, we are
seeking public comments on
methodologies that could be used to
determine the discount percentages. We
also are seeking public comments on
any other methodologies that could be
considered for the purposes of setting
bundled payment amounts.
• Mitigating risk of high-cost cases.
Depending on the breadth and scope of
an expansion, the potential financial
impact of high-cost episode cases could
be an issue for some providers.
Currently, under the BPCI initiative, we
apply a variety of approaches to risk
mitigation, including allowing
participants to select risk corridors that
limit the inclusion of high-cost cases in
episodes. We are seeking public
comments on strategies to mitigate the
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risk of high-cost cases to ensure
appropriate payment for these episodes
under model expansion, such as
through outlier or other policies, while
encouraging high-value, coordinated
care for these cases as well. For
example, under model expansion, we
potentially could establish an outlier
pool with specific payment policies,
similar to approaches under the IPPS
and the OPPS.
• Administering bundled payments.
We are seeking public comments on the
issues related to prospective or
retrospective payment under model
expansion. Currently, Model 4 under
the BPCI initiative makes a single
bundled payment, while Models 2 and
3 utilize routine Medicare FFS
payments to all providers and supplies
with retrospective reconciliation for the
awardee. We are interested in public
comments on the feasibility of different
payment approaches under the various
models, including the administrative
capacity and feasibility for some
organizations to pay others for care
during episodes or to share payments at
reconciliation. For example, under
model expansion, we potentially could
make a single bundled payment in all
models, but we would need to identify
the entity to receive the payments and
engage in widespread changes to the
shared systems to accommodate all
payment systems. Under the BPCI
initiative, we have agreements with
multiple types of entities, including
awardee conveners, that may not be
Medicare providers or suppliers. We are
requesting comments on the possibility
of paying an awardee convener the
bundled payment when that entity did
not actually deliver health care services
to the beneficiaries in episodes in an
expanded model. Specifically, we
would like to know what operational
and policy considerations would need
to be addressed. A retrospective
reconciliation would have different
concerns than a prospective payment.
• Data needs. We are seeking public
comments on the types of data and
functionality needed in the marketplace
in order to expand this type of model
(for example, EHRs and quality
measurement, among others). We
currently provide monthly episode
claims data to BPCI initiative
participants for purposes of health care
operations and periodic monitoring
reports. Under model expansion,
providers that are not fully integrated
may need to develop approaches to
sharing information regarding patients
initiating and participating in episodes.
Real-time information may improve the
coordination of care.
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• Use of health information
technology. We are seeking public
comments on how the use of health
information technology can be used and
encouraged in coordinating care across
care settings, including postacute care.
Health information technology and
health information exchange may be
used to support these models by sharing
summaries of care, problem lists,
physician orders, prescription lists, and
care plans across the care continuum.
We welcome public comments on how
to include SNFs, LTCHs, IRFs, and
HHAs that do not currently utilize
health information technology and
health information exchange at an
advanced level without compromising
the coordination of care among acute
care hospitals and postacute care
providers.
• Quality measurement and payment
for value. We are seeking public
comments on the quality measures that
could be applied to episodes and
approaches to incorporating value-based
payment in the BPCI initiative. For
example, under model expansion, we
potentially could apply the same quality
measures to all episodes or develop
episode-specific quality measures. We
potentially could incorporate valuebased payment under model expansion
by reducing the discount percentage for
high quality care or increasing the
discount percentage for low quality
care.
• Transition from Medicare FFS
payments to bundled payments. We are
seeking public comments on the need
for and parameters of a transition period
from Medicare FFS payment to bundled
payment under an expanded model. We
are seeking public comments regarding
the length of any transition and how
such a transition would be made.
• Other issues. We are seeking public
comments on any other issues the
public believes are important for us to
consider.
Consistent with our continuing
commitment to engaging stakeholders in
CMS’ work, we are seeking public
comments on these issues to broaden
and deepen our understanding of the
important issues and challenges
regarding bundled payments in the
current health care marketplace. These
public comments also will assist us in
planning for expansion if a decision is
made to expand the BPCI initiative in
the future.
I. Proposed Add-On Payments for New
Services and Technologies
1. Background
Sections 1886(d)(5)(K) and (L) of the
Act establish a process of identifying
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and ensuring adequate payment for new
medical services and technologies
(sometimes collectively referred to in
this section as ‘‘new technologies’’)
under the IPPS. Section
1886(d)(5)(K)(vi) of the Act specifies
that a medical service or technology will
be considered new if it meets criteria
established by the Secretary after notice
and opportunity for public comment.
Section 1886(d)(5)(K)(ii)(I) of the Act
specifies that a new medical service or
technology may be considered for new
technology add-on payment if, ‘‘based
on the estimated costs incurred with
respect to discharges involving such
service or technology, the DRG
prospective payment rate otherwise
applicable to such discharges under this
subsection is inadequate.’’ We note that
beginning with discharges occurring in
FY 2008, CMS transitioned from CMS–
DRGs to MS–DRGs.
The regulations at 42 CFR 412.87
implement these provisions and specify
three criteria for a new medical service
or technology to receive the additional
payment: (1) The medical service or
technology must be new; (2) the medical
service or technology must be costly
such that the DRG rate otherwise
applicable to discharges involving the
medical service or technology is
determined to be inadequate; and (3) the
service or technology must demonstrate
a substantial clinical improvement over
existing services or technologies. Below
we highlight some of the major statutory
and regulatory provisions relevant to the
new technology add-on payment criteria
as well as other information. For a
complete discussion on the new
technology add-on payment criteria, we
refer readers to the FY 2012 IPPS/LTCH
PPS final rule (76 FR 51572 through
51574).
Under the first criterion, as reflected
in § 412.87(b)(2), a specific medical
service or technology will be considered
‘‘new’’ for purposes of new medical
service or technology add-on payments
until such time as Medicare data are
available to fully reflect the cost of the
technology in the MS–DRG weights
through recalibration. We note that we
do not consider a service or technology
to be new if it is substantially similar to
one or more existing technologies. That
is, even if a technology receives a new
FDA approval, it may not necessarily be
considered ‘‘new’’ for purposes of new
technology add-on payments if it is
‘‘substantially similar’’ to a technology
that was approved by FDA and has been
on the market for more than 2 to 3 years.
In the FY 2006 IPPS final rule (70 FR
47351) and the FY 2010 IPPS/RY 2010
LTCH PPS final rule (74 FR 43813 and
43814), we explained our policy
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regarding substantial similarity in
detail.
Under the second criterion,
§ 412.87(b)(3) further provides that, to
be eligible for the add-on payment for
new medical services or technologies,
the MS–DRG prospective payment rate
otherwise applicable to the discharge
involving the new medical services or
technologies must be assessed for
adequacy. Under the cost criterion, to
assess the adequacy of payment for a
new technology paid under the
applicable MS–DRG prospective
payment rate, we evaluate whether the
charges for cases involving the new
technology exceed certain threshold
amounts. Table 10 that was released
with the FY 2015 IPPS/LTCH PPS final
rule contains the final thresholds that
we use to evaluate applications for new
technology add-on payments for FY
2016. We refer readers to the CMS Web
site at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/FY2015-IPPS-FinalRule-Home-Page-Items/FY2015-FinalRule-Tables.html to download and view
Table 10. We note that later in this
section under the discussion of the
WATCHMAN® Left Atrial Appendage
(LAA) Closure technology, we are
soliciting public comments on the use of
supplemental threshold values when
the coding to identify a new technology
is reassigned to a new MS–DRG that
does not have a threshold value
displayed in the most recent version of
Table 10.
In the September 7, 2001 final rule
that established the new technology
add-on payment regulations (66 FR
46917), we discussed the issue of
whether the Health Insurance
Portability and Accountability Act
(HIPAA) Privacy Rule at 45 CFR parts
160 and 164 applies to claims
information that providers submit with
applications for new technology add-on
payments. We refer readers to the FY
2012 IPPS/LTCH PPS final rule (76 FR
51573) for complete information on this
issue.
Under the third criterion,
§ 412.87(b)(1) of our existing regulations
provides that a new technology is an
appropriate candidate for an additional
payment when it represents ‘‘an
advance that substantially improves,
relative to technologies previously
available, the diagnosis or treatment of
Medicare beneficiaries.’’ For example, a
new technology represents a substantial
clinical improvement when it reduces
mortality, decreases the number of
hospitalizations or physician visits, or
reduces recovery time compared to the
technologies previously available. (We
refer readers to the September 7, 2001
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final rule for a more detailed discussion
of this criterion (66 FR 46902).)
The new medical service or
technology add-on payment policy
under the IPPS provides additional
payments for cases with relatively high
costs involving eligible new medical
services or technologies while
preserving some of the incentives
inherent under an average-based
prospective payment system. The
payment mechanism is based on the
cost to hospitals for the new medical
service or technology. Under § 412.88, if
the costs of the discharge (determined
by applying cost-to-charge ratios (CCRs)
as described in § 412.84(h)) exceed the
full DRG payment (including payments
for IME and DSH, but excluding outlier
payments), Medicare will make an addon payment equal to the lesser of: (1) 50
percent of the estimated costs of the
new technology (if the estimated costs
for the case including the new
technology exceed Medicare’s payment);
or (2) 50 percent of the difference
between the full DRG payment and the
hospital’s estimated cost for the case.
Unless the discharge qualifies for an
outlier payment, the additional
Medicare payment is limited to the full
MS–DRG payment plus 50 percent of
the estimated costs of the new
technology.
Section 503(d)(2) of Public Law 108–
173 provides that there shall be no
reduction or adjustment in aggregate
payments under the IPPS due to add-on
payments for new medical services and
technologies. Therefore, in accordance
with section 503(d)(2) of Public Law
108–173, add-on payments for new
medical services or technologies for FY
2005 and later years have not been
subjected to budget neutrality.
In the FY 2009 IPPS final rule (73 FR
48561 through 48563), we modified our
regulations at § 412.87 to codify our
longstanding practice of how CMS
evaluates the eligibility criteria for new
medical service or technology add-on
payment applications. That is, we first
determine whether a medical service or
technology meets the newness criterion,
and only if so, do we then make a
determination as to whether the
technology meets the cost threshold and
represents a substantial clinical
improvement over existing medical
services or technologies. We also
amended § 412.87(c) to specify that all
applicants for new technology add-on
payments must have FDA approval or
clearance for their new medical service
or technology by July 1 of each year
prior to the beginning of the fiscal year
that the application is being considered.
The Council on Technology and
Innovation (CTI) at CMS oversees the
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agency’s cross-cutting priority on
coordinating coverage, coding and
payment processes for Medicare with
respect to new technologies and
procedures, including new drug
therapies, as well as promoting the
exchange of information on new
technologies between CMS and other
entities. The CTI, composed of senior
CMS staff and clinicians, was
established under section 942(a) of
Public Law 108–173. The Council is cochaired by the Director of the Center for
Clinical Standards and Quality (CCSQ)
and the Director of the Center for
Medicare (CM), who is also designated
as the CTI’s Executive Coordinator.
The specific processes for coverage,
coding, and payment are implemented
by CM, CCSQ, and the local claimspayment contractors (in the case of local
coverage and payment decisions). The
CTI supplements, rather than replaces,
these processes by working to assure
that all of these activities reflect the
agency-wide priority to promote highquality, innovative care. At the same
time, the CTI also works to streamline,
accelerate, and improve coordination of
these processes to ensure that they
remain up to date as new issues arise.
To achieve its goals, the CTI works to
streamline and create a more
transparent coding and payment
process, improve the quality of medical
decisions, and speed patient access to
effective new treatments. It is also
dedicated to supporting better decisions
by patients and doctors in using
Medicare-covered services through the
promotion of better evidence
development, which is critical for
improving the quality of care for
Medicare beneficiaries.
To improve the understanding of
CMS’ processes for coverage, coding,
and payment and how to access them,
the CTI has developed an ‘‘Innovator’s
Guide’’ to these processes. The intent is
to consolidate this information, much of
which is already available in a variety
of CMS documents and in various
places on the CMS Web site, in a userfriendly format. This guide was
published in 2010 and is available on
the CMS Web site at: https://
www.cms.gov/CouncilonTechInnov/
Downloads/InnovatorsGuide5_10_
10.pdf.
As we indicated in the FY 2009 IPPS
final rule (73 FR 48554), we invite any
product developers or manufacturers of
new medical technologies to contact the
agency early in the process of product
development if they have questions or
concerns about the evidence that would
be needed later in the development
process for the agency’s coverage
decisions for Medicare.
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The CTI aims to provide useful
information on its activities and
initiatives to stakeholders, including
Medicare beneficiaries, advocates,
medical product manufacturers,
providers, and health policy experts.
Stakeholders with further questions
about Medicare’s coverage, coding, and
payment processes, or who want further
guidance about how they can navigate
these processes, can contact the CTI at
CTI@cms.hhs.gov.
We note that applicants for add-on
payments for new medical services or
technologies for FY 2017 must submit a
formal request, including a full
description of the clinical applications
of the medical service or technology and
the results of any clinical evaluations
demonstrating that the new medical
service or technology represents a
substantial clinical improvement, along
with a significant sample of data to
demonstrate that the medical service or
technology meets the high-cost
threshold. Complete application
information, along with final deadlines
for submitting a full application, will be
posted as it becomes available on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
newtech.html. To allow interested
parties to identify the new medical
services or technologies under review
before the publication of the proposed
rule for FY 2017, the CMS Web site also
will post the tracking forms completed
by each applicant.
2. Public Input Before Publication of a
Notice of Proposed Rulemaking on AddOn Payments
Section 1886(d)(5)(K)(viii) of the Act,
as amended by section 503(b)(2) of
Public Law 108–173, provides for a
mechanism for public input before
publication of a notice of proposed
rulemaking regarding whether a medical
service or technology represents a
substantial clinical improvement or
advancement. The process for
evaluating new medical service and
technology applications requires the
Secretary to—
• Provide, before publication of a
proposed rule, for public input
regarding whether a new service or
technology represents an advance in
medical technology that substantially
improves the diagnosis or treatment of
Medicare beneficiaries;
• Make public and periodically
update a list of the services and
technologies for which applications for
add-on payments are pending;
• Accept comments,
recommendations, and data from the
public regarding whether a service or
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technology represents a substantial
clinical improvement; and
• Provide, before publication of a
proposed rule, for a meeting at which
organizations representing hospitals,
physicians, manufacturers, and any
other interested party may present
comments, recommendations, and data
regarding whether a new medical
service or technology represents a
substantial clinical improvement to the
clinical staff of CMS.
In order to provide an opportunity for
public input regarding add-on payments
for new medical services and
technologies for FY 2016 prior to
publication of the FY 2016 IPPS/LTCH
PPS proposed rule, we published a
notice in the Federal Register on
November 21, 2014 (79 FR 69490), and
held a town hall meeting at the CMS
Headquarters Office in Baltimore, MD,
on February 3, 2015. In the
announcement notice for the meeting,
we stated that the opinions and
alternatives provided during the
meeting would assist us in our
evaluations of applications by allowing
public discussion of the substantial
clinical improvement criterion for each
of the FY 2016 new medical service and
technology add-on payment
applications before the publication of
the FY 2016 IPPS/LTCH PPS proposed
rule.
Approximately 95 individuals
registered to attend the town hall
meeting in person, while additional
individuals listened over an open
telephone line. We also live-streamed
the town hall meeting and posted the
town hall on the CMS YouTube Web
page at: https://www.youtube.com/
watch?v=dn-R5KGQu-M. We considered
each applicant’s presentation made at
the town hall meeting, as well as written
comments submitted on the
applications that were received by the
due date of January 19, 2015, in our
evaluation of the new technology addon payment applications for FY 2016 in
this proposed rule.
In response to the published notice
and the New Technology Town Hall
meeting, we received written comments
regarding the applications for FY 2016
new technology add-on payments. We
summarize these comments in the
preamble of this proposed rule or, if
applicable, indicate that there were no
comments received, at the end of each
discussion of the individual
applications in this proposed rule.
One commenter provided comments
that were unrelated to the ‘‘substantial
clinical improvement’’ criterion. As
explained above and in the Federal
Register notice announcing the New
Technology Town Hall meeting (79 FR
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69490 through 69492), the purpose of
the meeting was specifically to discuss
the substantial clinical improvement
criterion in regard to pending new
technology add-on payment
applications for FY 2016. Therefore, we
are not summarizing the commenter’s
comments in this proposed rule. The
commenter is welcome to resubmit its
comments in response to proposals
presented in this proposed rule.
Comment: One commenter stated that
antibiotics are unique because their
development and use present many
challenges that are not applicable to
other drugs or devices seeking approval
for new technology add-on payments.
The commenter urged CMS to utilize
the expertise of the infectious diseases
community when determining how to
evaluate applications for new antibiotics
for new technology add-on payments.
The commenter further stated that
because superiority studies cannot be
conducted for most serious infections,
the most appropriate evaluation of
superiority for many new antibiotics is
a ‘‘noninferiority’’ clinical trial, which
is designed to determine if the
experimental drug is similar in efficacy
to a standard drug currently available on
the market. The commenter noted that,
recently, the FDA has demonstrated
increased willingness to consider
approving new antibiotics if efficacy can
be proven based on achieved, welldefined, and statistically validated
noninferiority margins. The commenter
encouraged CMS to consider the proven
efficacy of these antibiotics based on
these criteria when determining
whether to approve a new antibiotic for
new technology add-on payment. The
commenter also urged CMS to consider
carefully analyzed and peer-reviewed
safety, utilization, and economics data
when such data are available to support
the approval of a new antibiotic for new
technology add-on payment. The
commenter believed that these
considerations could increase the types
of information that would be used to
support the approval of new drugs for
which superiority trials are
inappropriate or not feasible or both.
The commenter also believed it is
critical that CMS maintain an ongoing
dialogue with the FDA as well as
nongovernment experts in antibiotic
resistance and antibiotic drug
development in order to more fully
understand the highly complex and
unique issues regarding the type of data
available for the study and approval of
new antibiotics.
Response: In our evaluation of new
technology applications, we rely on the
recommendations of our clinical
advisors. We also consider all clinical
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data provided by the applicant in our
determination of whether a technology
is eligible for new technology add-on
payments. In addition, we summarize
each application and invite the public to
provide their comments and expertise
on any new technology application
under consideration during the
comment period for the proposed rule.
We also work with the FDA in instances
where guidance is necessary to
understand the complexities of a new
technology. We appreciate the
commenter’s input, and we will further
consider these comments in future
rulemakings.
We note that the commenter provided
comments that were unrelated to the
substantial clinical improvement
criterion. As noted above, the purpose
of the new technology town hall
meeting was specifically to discuss the
substantial clinical improvement
criterion in regard to pending new
technology add-on payment
applications for FY 2016. Therefore, we
are not summarizing these comments in
this proposed rule. The commenter is
welcome to resubmit its comments in
response to proposals presented in this
proposed rule.
3. Implementation of ICD–10–PCS
Section ‘‘X’’ Codes for Certain New
Medical Services and Technologies for
FY 2016
As discussed in section II.G.1.a. of the
preamble of this proposed rule, health
plans and providers are required, as of
October 1, 2015, to use the ICD–10
coding system (ICD–10–PCS codes for
procedures and ICD–10–CM codes for
diagnosis), instead of the ICD–9–CM
coding system, to report diagnoses and
procedures for Medicare hospital
inpatient services provided to Medicare
beneficiaries as classified under the
MS–DRG system and paid for under the
IPPS. HIPAA covered entities will
continue to use ICD–9–CM coding
practices and principles through
September 30, 2015. We refer readers to
section II.G.1.a. of the preamble of this
proposed rule for a complete discussion
of the adoption of the ICD–10 coding
system.
As part of the transition to the ICD–
10–CM/PCS coding system, at the
September 23–24, 2014 ICD–10
Coordination and Maintenance
Committee meeting, CMS received a
request to create a new section within
the ICD–10–PCS to capture new medical
services and technologies that might not
appropriately align with the current
structure of the ICD–10–PCS codes.
Examples of these types of new medical
services and technologies included
drugs, biologicals, and newer medical
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devices being tested in clinical trials
that are not currently captured within
the ICD–9–CM or the ICD–10–PCS. The
requestor indicated that there may be a
need to identify and report these
technologies and inpatient services for
purposes of approving new technology
add-on payment applications and
initiating subsequent new technology
add-on payments based on approval or
tracking and analyzing the use of these
new technologies and services.
Although several commenters have
opposed including these types of
technologies and services within the
current structure of the ICD–10–PCS
codes during past ICD–10 Coordination
and Maintenance Committee meetings,
as well as in public comments, CMS has
evaluated these suggestions and
considered them to be valid. As a result,
CMS has created a new component
within the ICD–10–PCS codes, labeled
Section ‘‘X’’ codes, to identify and
describe these new technologies and
services. The new Section ‘‘X’’ codes
identify new medical services and
technologies that are not usually
captured by coders, or that do not
usually have the desired specificity
within the current ICD–10–PCS
structure required to capture the use of
these new services and technologies. As
mentioned earlier, examples of these
types of services and technologies
include specific drugs, biologicals, and
newer medical devices being tested in
clinical trials. The new Section ‘‘X’’
codes within the ICD–10–PCS structure
will be implemented on October 1,
2015, and will be used to identify new
technologies and medical services
approved under the new technology
add-on payment policy for payment
purposes beginning October 1, 2015. An
overview of Section ‘‘X’’ codes was
provided at the March 18–19, 2015 ICD–
10 Coordination and Maintenance
Committee meeting. Further information
regarding the new Section ‘‘X’’ codes
and their use within the ICD–10–PCS
can be found on the CMS Web site at:
https://www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html
through the ‘‘CMS Coordination and
Maintenance Committee Meeting’’ link.
The ICD–10–PCS includes a new
section containing the new Section ‘‘X’’
codes, which will be used beginning FY
2016. Decisions regarding changes to
ICD–10–PCS Section ‘‘X’’ codes will be
handled in the same manner as the
decisions for all of the other ICD–10–
PCS code changes. That is, proposals to
create, delete, or revise Section ‘‘X’’
codes under the ICD–10–PCS structure
will be referred to the ICD–10
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Coordination and Maintenance
Committee. In addition, several of the
new medical services and technologies
that have been, or may be, approved for
new technology add-on payments may
now, and in the future, be assigned a
Section ‘‘X’’ code within the structure of
the ICD–10–PCS. The FY 2016 ICD–10–
PCS Section ‘‘X’’ codes will be posted
in June 2015 on the Internet via the
CMS Web site at: https://www.cms.gov/
Medicare/Coding/ICD10/
under the links on the left side of the
Web page.
4. Proposed FY 2016 Status of
Technologies Approved for FY 2015
Add-On Payments
a. Glucarpidase (Voraxaze®)
BTG International, Inc. submitted an
application for new technology add-on
payments for Glucarpidase (Voraxaze®)
for FY 2013. Glucarpidase is used in the
treatment of patients who have been
diagnosed with toxic methotrexate
(MTX) concentrations as of result of
renal impairment. The administration of
Glucarpidase causes a rapid and
sustained reduction of toxic MTX
concentrations.
Voraxaze® was approved by the FDA
on January 17, 2012. Beginning in 1993,
certain patients could obtain expanded
access for treatment use to Voraxaze® as
an investigational drug. Since 2007, the
applicant has been authorized to recover
the costs of making Voraxaze® available
through its expanded access program.
We describe expanded access for
treatment use of investigational drugs
and authorization to recover certain
costs of investigational drugs in the FY
2013 IPPS/LTCH PPS final rule (77 FR
53346 through 53350). Voraxaze® was
available on the market in the United
States as a commercial product to the
larger population as of April 30, 2012.
In the FY 2013 IPPS/LTCH PPS
proposed rule (77 FR 27936 through
27939), we expressed concerns about
whether Voraxaze® could be considered
new for FY 2013. After consideration of
all of the public comments received, in
the FY 2013 IPPS/LTCH PPS final rule,
we stated that we considered Voraxaze®
to be ‘‘new’’ as of April 30, 2012, which
is the date of market availability.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology payments for
Voraxaze® and consideration of the
public comments we received in
response to the FY 2013 IPPS/LTCH
PPS proposed rule, we approved
Voraxaze® for new technology add-on
payments for FY 2013. Cases of
Voraxaze® are identified with ICD–9–
CM procedure code 00.95 (Injection or
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infusion of glucarpidase). As stated in
the FY 2015 IPPS/LTCH PPS final rule
correction notice (79 FR 59679), the cost
of Voraxaze® is $23,625 per vial. The
applicant stated that an average of four
vials is used per Medicare beneficiary.
Therefore, the average cost per case for
Voraxaze® is $94,500 ($23,625 × 4).
Under § 412.88(a)(2), new technology
add-on payments are limited to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment for
Voraxaze® is $47,250 per case.
As stated above, the new technology
add-on payment regulations provide
that ‘‘a medical service or technology
may be considered new within 2 or 3
years after the point at which data begin
to become available reflecting the ICD–
9–CM code assigned to the new service
or technology’’ (§ 412.87(b)(2)). Our
practice has been to begin and end new
technology add-on payments on the
basis of a fiscal year, and we have
generally followed a guideline that uses
a 6-month window before and after the
start of the fiscal year to determine
whether to extend the new technology
add-on payment for an additional fiscal
year. In general, we extend add-on
payments for an additional year only if
the 3-year anniversary date of the
product’s entry on the market occurs in
the latter half of the fiscal year (70 FR
47362).
With regard to the newness criterion
for Voraxaze®, we considered the
beginning of the newness period to
commence when Voraxaze® was first
made available on the U.S. market on
April 30, 2012. Because the 3-year
anniversary date for Voraxaze® occurred
in the latter half of FY 2015 (April 30,
2015), in the FY 2015 IPPS/LTCH PPS
final rule, we continued new technology
add-on payments for this technology for
FY 2015 (79 FR 49918). However, for FY
2016, the 3-year anniversary date of the
product’s entry on the U.S. market
(April 30, 2015) occurs prior to the
beginning of FY 2016. Therefore, we are
proposing to discontinue new
technology add-on payments for
Voraxaze® for FY 2016. We are inviting
public comments on this proposal.
b. Zenith® Fenestrated Abdominal
Aortic Aneurysm (AAA) Endovascular
Graft
Cook® Medical submitted an
application for new technology add-on
payments for the Zenith® Fenestrated
Abdominal Aortic Aneurysm (AAA)
Endovascular Graft (Zenith® F. Graft) for
FY 2013. The applicant stated that the
current treatment for patients who have
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had an AAA is an endovascular graft.
The applicant explained that the
Zenith® F. Graft is an implantable
device designed to treat patients who
have an AAA and who are anatomically
unsuitable for treatment with currently
approved AAA endovascular grafts
because of the length of the infrarenal
aortic neck. The applicant noted that,
currently, an AAA is treated through an
open surgical repair or medical
management for those patients not
eligible for currently approved AAA
endovascular grafts.
With respect to newness, the
applicant stated that FDA approval for
the use of the Zenith® F. Graft was
granted on April 4, 2012. In the FY 2013
IPPS/LTCH PPS final rule (77 FR 53360
through 53365), we stated that because
the Zenith® F. Graft was approved by
the FDA on April 4, 2012, we believed
that the Zenith® F. Graft met the
newness criterion as of that date.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for the Zenith® F. Graft and
consideration of the public comments
we received in response to the FY 2013
IPPS/LTCH PPS proposed rule, we
approved the Zenith® F. Graft for new
technology add-on payments for FY
2013. Cases involving the Zenith® F.
Graft that are eligible for new
technology add-on payments currently
are identified by ICD–9–CM procedure
code 39.78 (Endovascular implantation
of branching or fenestrated graft(s) in
aorta). In the application, the applicant
provided a breakdown of the costs of the
Zenith® F. Graft. The total cost of the
Zenith® F. Graft utilizing bare metal
(renal) alignment stents was $17,264. Of
the $17,264 in costs for the Zenith® F.
Graft, $921 is for components that are
used in a standard Zenith AAA
Endovascular Graft procedure. Because
the costs for these components are
already reflected within the MS–DRGs
(and are no longer ‘‘new’’), in the FY
2013 IPPS/LTCH PPS final rule, we
stated that we do not believe it is
appropriate to include these costs in our
calculation of the maximum cost to
determine the maximum add-on
payment for the Zenith® F. Graft.
Therefore, the total maximum cost for
the Zenith® F. Graft is $16,343
($17,264–$921). Under § 412.88(a)(2),
new technology add-on payments are
limited to the lesser of 50 percent of the
average cost of the device or 50 percent
of the costs in excess of the MS–DRG
payment for the case. As a result, the
maximum add-on payment for a case
involving the Zenith® F. Graft is
$8,171.50.
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With regard to the newness criterion
for the Zenith® F. Graft, we considered
the beginning of the newness period to
commence when the Zenith® F. Graft
was approved by the FDA on April 4,
2012. Because the 3-year anniversary
date of the entry of the Zenith® F. Graft
on the U.S. market occurred in the
second half of FY 2015 (April 4, 2015),
in the FY 2015 IPPS/LTCH PPS final
rule, we continued new technology addon payments for this technology for FY
2015 (79 FR 49922). However, for FY
2016, the 3-year anniversary date of the
product’s entry on the U.S. market
(April 4, 2015) occurs prior to the
beginning of FY 2016. Therefore, we are
proposing to discontinue new
technology add-on payments for the
Zenith® F. Graft for FY 2016. We are
inviting public comments on this
proposal.
c. KcentraTM
CSL Behring submitted an application
for new technology add-on payments for
KcentraTM for FY 2014. KcentraTM is a
replacement therapy for fresh frozen
plasma (FFP) for patients with an
acquired coagulation factor deficiency
due to warfarin and who are
experiencing a severe bleed. KcentraTM
contains the Vitamin K dependent
coagulation factors II, VII, IX and X,
together known as the prothrombin
complex, and antithrombotic proteins C
and S. Factor IX is the lead factor for the
potency of the preparation. The product
is a heat-treated, non-activated, virus
filtered and lyophilized plasma protein
concentrate made from pooled human
plasma. KcentraTM is available as a
lyophilized powder that needs to be
reconstituted with sterile water prior to
administration via intravenous infusion.
The product is dosed based on Factor IX
units. Concurrent Vitamin K treatment
is recommended to maintain blood
clotting factor levels once the effects of
KcentraTM have diminished.
KcentraTM was approved by the FDA
on April 29, 2013. In the FY 2014 IPPS/
LTCH PPS final rule, we finalized new
ICD–9–CM procedure code 00.96
(Infusion of 4-Factor Prothrombrin
Complex Concentrate) which uniquely
identifies KcentraTM.
In the FY 2014 IPPS/LTCH PPS
proposed rule (78 FR 27538), we noted
that we were concerned that KcentraTM
may be substantially similar to FFP and/
or Vitamin K therapy. In the FY 2014
IPPS/LTCH PPS final rule, in response
to comments submitted by the
manufacturer, we stated that we agree
that KcentraTM may be used in a patient
population that is experiencing an
acquired coagulation factor deficiency
due to Warfarin and who are
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experiencing a severe bleed currently
but are ineligible for FFP, particularly
for use by IgA deficient patients and
other patient populations that have no
other treatment option to resolve severe
bleeding in the context of an acquired
Vitamin K deficiency. In addition, FFP
is limited because it requires special
storage conditions while KcentraTM is
stable for up to 36 months at room
temperature thus allowing hospitals that
otherwise would not have access to FFP
(for example, small rural hospitals as
discussed by the applicant in its
comments) to keep a supply of
KcentraTM and treat patients who would
possibly have no access to FFP. We
noted that FFP is considered perishable
and can be scarce by nature (due to
production and other market
limitations) thus making some hospitals
unable to store FFP, which limits access
to certain patient populations in certain
locations. Therefore, we stated that we
believe that KcentraTM provides a
therapeutic option for a new patient
population and is not substantially
similar to FFP. Also, we gave credence
to the information presented by the
manufacturer that KcentraTM provides a
simple and rapid repletion relative to
FFP and reduces the risk of a
transfusion reaction relative to FFP
because it does not contain ABO
antibodies and does not require ABO
typing. As a result, we concluded that
KcentraTM is not substantially similar to
FFP, and that it meets the newness
criterion.
After evaluation of the newness, cost,
and substantial clinical improvement
criteria for new technology add-on
payments for KcentraTM and
consideration of the public comments
we received in response to the FY 2014
IPPS/LTCH PPS proposed rule, we
approved KcentraTM for new technology
add-on payments for FY 2014 (78 FR
50575 through 50580). Cases involving
KcentraTM that are eligible for new
technology add-on payments currently
are identified by ICD–9–CM procedure
code 00.96. In the application, the
applicant estimated that the average
Medicare beneficiary would require an
average dosage of 2500 International
Units (IU). Vials contain 500 IU at a cost
of $635 per vial. Therefore, cases of
KcentraTM would incur an average cost
per case of $3,175 ($635 × 5). Under
§ 412.88(a)(2), new technology add-on
payments are limited to the lesser of 50
percent of the average cost of the
technology or 50 percent of the costs in
excess of the MS–DRG payment for the
case. As a result, the maximum add-on
payment for a case of KcentraTM was
$1,587.50 for FY 2014.
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In the FY 2014 IPPS/LTCH PPS final
rule (78 FR 50579), we stated that new
technology add-on payments for
KcentraTM would not be available with
respect to discharges for which the
hospital received an add-on payment for
a blood clotting factor administered to a
Medicare beneficiary with hemophilia
who is a hospital inpatient. Under
section 1886(d)(1)(A)(iii) of the Act, the
national adjusted DRG prospective
payment rate is ‘‘the amount of the
payment with respect to the operating
costs of inpatient hospital services (as
defined in subsection (a)(4) of this
section)’’ for discharges on or after April
1, 1988. Section 1886(a)(4) of the Act
excludes from the term ‘‘operating costs
of inpatient hospital services’’ the costs
with respect to administering blood
clotting factors to individuals with
hemophilia. The costs of administering
a blood clotting factor to a Medicare
beneficiary who has hemophilia and is
a hospital inpatient are paid separately
from the IPPS. (For information on how
the blood clotting factor add-on
payment is made, we refer readers to
Section 20.7.3, Chapter 3, of the
Medicare Claims Processing Manual,
which can be downloaded from the
CMS Web site at: https://cms.gov/
Regulations-and-Guidance/Guidance/
Manuals/Downloads/clm104c03.pdf.) In
addition, we stated that if KcentraTM is
approved by the FDA as a blood clotting
factor, we believed that it may be
eligible for blood clotting factor add-on
payments when administered to
Medicare beneficiaries with hemophilia.
We make an add-on payment for
KcentraTM for such discharges in
accordance with our policy for payment
of a blood clotting factor, and the costs
would be excluded from the operating
costs of inpatient hospital services as set
forth in section 1886(a)(4) of the Act.
Section 1886(d)(5)(K)(i) of the Act
requires the Secretary to ‘‘establish a
mechanism to recognize the costs of
new medical services and technologies
under the payment system established
under this subsection’’ beginning with
discharges on or after October 1, 2001.
We believe that it is reasonable to
interpret this requirement to mean that
the payment mechanism established by
the Secretary recognizes only costs for
those items that would otherwise be
paid based on the prospective payment
system (that is, ‘‘the payment system
established under this subsection’’). As
noted above, under section
1886(d)(1)(A)(iii) of the Act, the national
adjusted DRG prospective payment rate
is the amount of payment for the
operating costs of inpatient hospital
services, as defined in section 1886(a)(4)
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24423
of the Act, for discharges on or after
April 1, 1988. We understand this to
mean that a new medical service or
technology must be an operating cost of
inpatient hospital services paid based
on the prospective payment system, and
not excluded from such costs, in order
to be eligible for the new technology
add-on payment. We pointed out that
new technology add-on payments are
based on the operating costs per case
relative to the prospective payment rate
as described in § 412.88. Therefore, we
believe that new technology add-on
payments are appropriate only when the
new technology is an operating cost of
inpatient hospital services and are not
appropriate when the new technology is
excluded from such costs.
In the FY 2014 IPPS/LTCH PPS final
rule (78 FR 50579), we stated that we
believe that hospitals may only receive
new technology add-on payments for
discharges where KcentraTM is an
operating cost of inpatient hospital
services. In other words, a hospital
would not be eligible to receive the new
technology add-on payment when it is
administering KcentraTM in treating a
Medicare beneficiary who has
hemophilia. In those instances,
KcentraTM is specifically excluded from
the operating costs of inpatient hospital
services in accordance with section
1886(a)(4) of the Act and paid separately
from the IPPS. However, when a
hospital administers KcentraTM to a
Medicare beneficiary who does not have
hemophilia, the hospital would be
eligible for a new technology add-on
payment because KcentraTM would not
be excluded from the operating costs of
inpatient hospital services. Therefore,
discharges where the hospital receives a
blood clotting factor add-on payment
are not eligible for a new technology
add-on payment for the blood clotting
factor. We refer readers to Section
20.7.3, Chapter 3, of the Medicare
Claims Processing Manual for a
complete discussion on when a blood
clotting factor add-on payment is made.
The manual can be downloaded from
the CMS Web site at: https://
www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
Downloads/clm104c03.pdf.
With regard to the newness criterion
for KcentraTM, we considered the
beginning of the newness period to
commence when KcentraTM was
approved by the FDA on April 29, 2013.
Because the 3-year anniversary date of
the entry of KcentraTM on the U.S.
market will occur in the second half of
FY 2016 (April 29, 2016), we are
proposing to continue new technology
add-on payments for this technology for
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FY 2016. We are inviting public
comments on this proposal.
Because we are adopting the ICD–10
coding system, effective October 1,
2015, as discussed in section II.G.1.a. of
the preamble of this proposed rule, for
FY 2016, we are proposing to identify
and make new technology add-on
payments for cases involving the
KcentraTM technology with ICD–10–PCS
procedure code 30283B1 (Transfusion of
nonautologous 4-factor prothrombin
complex concentrate into vein,
percutaneous approach). As stated
above, new technology add-on
payments for KcentraTM would not be
available with respect to discharges for
which the hospital received an add-on
payment for a blood clotting factor
administered to a Medicare beneficiary
with hemophilia who is a hospital
inpatient. For information on how the
blood clotting factor add-on payment is
made (including a list of ICD–10
diagnosis codes that would negate the
eligibility of a case for new technology
add-on payments, if reported in
combination with the proposed ICD–10
procedure code used to identify cases
involving the KcentraTM technology), we
refer readers to Section 20.7.3, Chapter
3, of the Medicare Claims Processing
Manual, which can be downloaded from
the CMS Web site at: https://cms.gov/
Regulations-and-Guidance/Guidance/
Manuals/Downloads/clm104c03.pdf.
The maximum new technology add-on
payment for a case involving the
KcentraTM technology would remain at
$1,587.50 for FY 2016. We are inviting
public comments on this proposal.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
d. Argus® II Retinal Prosthesis System
Second Sight Medical Products, Inc.
submitted an application for new
technology add-on payments for the
Argus® II Retinal Prosthesis System
(Argus® II System) for FY 2014. The
Argus® II System is an active
implantable medical device that is
intended to provide electrical
stimulation of the retina to induce
visual perception in patients who are
profoundly blind due to retinitis
pigmentosa (RP). These patients have
bare or no light perception in both eyes.
The system employs electrical signals to
bypass dead photo-receptor cells and
stimulate the overlying neurons
according to a real-time video signal
that is wirelessly transmitted from an
externally worn video camera. The
Argus® II implant is intended to be
implanted in a single eye, typically the
worse-seeing eye. Currently, bilateral
implants are not intended for this
technology. According to the applicant,
the surgical implant procedure takes
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approximately 4 hours and is performed
under general anesthesia.
The Argus® II System consists of three
primary components: (1) An implant
which is an epiretinal prosthesis that is
fully implanted on and in the eye (that
is, there are no percutaneous leads); (2)
external components worn by the user;
and (3) a ‘‘fitting’’ system for the
clinician that is periodically used to
perform diagnostic tests with the system
and to custom-program the external unit
for use by the patient. We describe these
components more fully below.
• Implant: The retinal prosthesis
implant is responsible for receiving
information from the external
components of the system and
electrically stimulating the retina to
induce visual perception. The retinal
implant consists of: (a) A receiving coil
for receiving information and power
from the external components of the
Argus® II System; (b) electronics to
drive stimulation of the electrodes; and
(c) an electrode array. The receiving coil
and electronics are secured to the
outside of the eye using a standard
scleral band and sutures, while the
electrode array is secured to the surface
of the retina inside the eye by a retinal
tack. A cable, which passes through the
eye wall, connects the electronics to the
electrode array. A pericardial graft is
placed over the extra-ocular portion on
the outside of the eye.
• External Components: The implant
receives power and data commands
wirelessly from an external unit of
components, which include the Argus II
Glasses and Video Processing Unit
(VPU). A small lightweight video
camera and transmitting coil are
mounted on the glasses. The telemetry
coils and radio-frequency system are
mounted on the temple arm of the
glasses for transmitting data from the
VPU to the implant. The glasses are
connected to the VPU by a cable. This
VPU is worn by the patient, typically on
a belt or a strap, and is used to process
the images from the video camera and
convert the images into electrical
stimulation commands, which are
transmitted wirelessly to the implant.
• ‘‘Fitting System’’: To be able to use
the Argus® II System, a patient’s VPU
needs to be custom-programmed. This
process, which the applicant called
‘‘fitting’’, occurs in the hospital/clinic
shortly after the implant surgery and
then periodically thereafter as needed.
The clinician/physician also uses the
‘‘Fitting System’’ to run diagnostic tests
(for example, to obtain electrode and
impedance waveform measurements or
to check the radio-frequency link
between the implant and external unit).
This ‘‘Fitting System’’ can also be
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connected to a ‘‘Psychophysical Test
System’’ to evaluate patients’
performance with the Argus® II System
on an ongoing basis.
These three components work
together to stimulate the retina and
allow a patient to perceive phosphenes
(spots of light), which they then need to
learn to interpret. While using the
Argus® II System, the video camera on
the patient-worn glasses captures a
video image. The video camera signal is
sent to the VPU, which processes the
video camera image and transforms it
into electrical stimulation patterns. The
electrical stimulation data are then sent
to a transmitter coil mounted on the
glasses. The transmitter coil sends both
data and power via radio-frequency (RF)
telemetry to the implanted retinal
prosthesis. The implant receives the RF
commands and delivers stimulation to
the retina via an array of electrodes that
is secured to the retina with a retinal
tack.
In patients with RP, the photoreceptor
cells in the retina, which normally
transduce incoming light into an
electro-chemical signal, have lost most
of their function. The stimulation pulses
delivered to the retina via the electrode
array of the Argus® II System are
intended to mimic the function of these
degenerated photoreceptors cells. These
pulses induce cellular responses in the
remaining, viable retinal nerve cells that
travel through the optic nerve to the
visual cortex where they are perceived
as phosphenes (spots of light). Patients
learn to interpret the visual patterns
produced by these phosphenes.
With respect to the newness criterion,
according to the applicant, the FDA
designated the Argus® II System a
Humanitarian Use Device in May 2009
(HUD designation #09–0216). The
applicant submitted a Humanitarian
Device Exemption (HDE) application
(#H110002) to the FDA in May 2011 to
obtain market approval for the Argus® II
System. The HDE was referred to the
Ophthalmic Devices Panel of the FDA’s
Medical Devices Advisory Committee
for review and recommendation. At the
Panel’s meeting held on September 28,
2012, the Panel voted 19 to 0 that the
probable benefits of the Argus® II
System outweigh the risks of the system
for the proposed indication for use. The
applicant received the HDE approval
from the FDA on February 14, 2013.
However, in the FY 2015 IPPS/LTCH
PPS final rule (79 FR 49924 through
49925), we discussed comments we had
received informing CMS that the Argus®
II System was not available on the U.S.
market until December 20, 2013. The
applicant explained that, as part of the
lengthy approval process, it was
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required to submit a request to the
Federal Communications Commission
(FCC) for a waiver of section 15.209(a)
of the FCC rules that would allow the
applicant to apply for FCC authorization
to utilize this specific RF band. The FCC
approved the applicant’s waiver request
on November 30, 2011. After receiving
the FCC waiver of the section 15.209(a)
rules, the applicant requested and
obtained a required Grant of Equipment
Authorization to utilize the specific RF
band, which the FCC issued on
December 20, 2013. Therefore, the
applicant stated that the date the Argus®
II System first became available for
commercial sale in the United States
was December 20, 2013. We agreed with
the applicant that, due to the delay, the
date of newness for the Argus® II
System was December 20, 2013, instead
of February 14, 2013.
Currently there are no other approved
treatments for patients diagnosed with
severe to profound RP. The Argus® II
System has an IDE number of G050001
and is a Class III device. In the FY 2014
IPPS/LTCH PPS final rule (78 FR 50580
through 50583), we finalized new ICD–
9–CM procedure code 14.81
(Implantation of epiretinal visual
prosthesis), which uniquely identifies
the Argus® II System. The other two
codes finalized by CMS are for removal,
revision, or replacement of the device.
After evaluation of the new
technology add-on payment application
and consideration of public comments
received, we concluded that the Argus®
II System met all of the new technology
add-on payment policy criteria.
Therefore, we approved the Argus® II
System for new technology add-on
payments in FY 2014 (78 FR 50580
through 50583). Cases involving the
Argus® II System that are eligible for
new technology add-on payments
currently are identified by ICD–9–CM
procedure code 14.81. We note that
section 1886(d)(5)(K)(i) of the Act
requires that the Secretary establish a
mechanism to recognize the costs of
new medical services or technologies
under the payment system established
under that subsection, which establishes
the system for paying for the operating
costs of inpatient hospital services. The
system of payment for capital costs is
established under section 1886(g) of the
Act, which makes no mention of any
add-on payments for a new medical
service or technology. Therefore, it is
not appropriate to include capital costs
in the add-on payments for a new
medical service or technology. In the
application, the applicant provided a
breakdown of the costs of the Argus® II
System. The total operating cost of the
Argus® II System is $144,057.50. Under
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§ 412.88(a)(2), new technology add-on
payments are limited to the lesser of 50
percent of the average cost of the device
or 50 percent of the costs in excess of
the MS–DRG payment for the case. As
a result, the maximum add-on payment
for a case involving the Argus® II
System for FY 2014 was $72,028.75.
With regard to the newness criterion
for the Argus® II System, we considered
the beginning of the newness period to
commence when the Argus® II System
became available on the U.S. market on
December 20, 2013. Because the 3-year
anniversary date of the entry of the
Argus® II System on the U.S. market
will occur in the first half of FY 2017
(December 23, 2016), we are proposing
to continue new technology add-on
payments for this technology for FY
2016. We are inviting public comments
on this proposal.
Because we are adopting the ICD–10
coding system, effective October 1,
2015, as discussed in section II.G.1.a. of
the preamble of this proposed rule, for
FY 2016, we are proposing to identify
and make new technology add-on
payments for cases involving the Argus®
II System when one of the following
ICD–10–PCS procedure codes is
reported: 08H005Z (Insertion of
epiretinal visual prosthesis into right
eye, open approach) or 08H105Z
(Insertion of epiretinal visual prosthesis
into left eye, open approach). The
maximum new technology add-on
payment for a case involving the Argus®
II System would remain at $72,028.75
for FY 2016. We are inviting public
comments on this proposal.
e. Zilver® PTX® Drug Eluting Peripheral
Stent
Cook® Medical submitted an
application for new technology add-on
payments for the Zilver® PTX® Drug
Eluting Peripheral Stent (Zilver® PTX®)
for FY 2014. The Zilver® PTX® is
intended for use in the treatment of
peripheral artery disease (PAD) of the
above–the-knee femoropopliteal arteries
(superficial femoral arteries). According
to the applicant, the stent is
percutaneously inserted into the
artery(s), usually by accessing the
common femoral artery in the groin. The
applicant stated that an introducer
catheter is inserted over the wire guide
and into the target vessel where the
lesion will first be treated with an
angioplasty balloon to prepare the
vessel for stenting. The applicant
indicated that the stent is selfexpanding, made of nitinol (nickel
titanium), and is coated with the drug
Paclitaxel. Paclitaxel is a drug approved
for use as an anticancer agent and for
use with coronary stents to reduce the
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risk of renarrowing of the coronary
arteries after stenting procedures.
The applicant received FDA approval
on November 15, 2012, for the Zilver®
PTX®. The applicant maintains that the
Zilver® PTX® is the first drug-eluting
stent used for superficial femoral
arteries. The technology is currently
described by ICD–9–CM procedure code
00.60 (Insertion of drug-eluting stent(s)
of the superficial femoral artery).
In the FY 2014 IPPS/LTCH PPS final
rule (78 FR 50583 through 50585), after
evaluation of the new technology addon payment application and
consideration of the public comments
received, we approved the Zilver® PTX®
for new technology add-on payments in
FY 2014. Cases involving the Zilver®
PTX® that are eligible for new
technology add-on payments are
identified by ICD–9–CM procedure code
00.60. As explained in the FY 2014
IPPS/LTCH PPS final rule, to determine
the amount of Zilver® PTX® stents per
case, instead of using the amount of
stents used per case based on the ICD–
9–CM codes, the applicant used an
average of 1.9 stents per case based on
the Zilver® PTX® Global Registry
Clinical Study. The applicant stated in
its application that the anticipated cost
per stent is approximately $1,795.
Therefore, cases of the Zilver® PTX®
would incur an average cost per case of
$3,410.50 ($1,795 × 1.9). Under
§ 412.88(a)(2), new technology add-on
payments are limited to the lesser of 50
percent of the average cost of the device
or 50 percent of the costs in excess of
the MS–DRG payment for the case. As
a result, the maximum add-on payment
for a case of the Zilver® PTX® was
$1,705.25 for FY 2014.
With regard to the newness criterion
for the Zilver® PTX®, we considered the
beginning of the newness period to
commence when the Zilver® PTX® was
approved by the FDA on November 15,
2012. Because the 3-year anniversary
date of the entry of the Zilver® PTX® on
the U.S. market occurred after FY 2015
(November 15, 2015), in the FY 2015
IPPS/LTCH PPS final rule, we
continued new technology add-on
payments for this technology for FY
2015 (79 FR 49925). However, for FY
2016, the 3-year anniversary date of the
product’s entry on the U.S. market
(November 15, 2015) occurs in the first
half of FY 2016. Therefore, we are
proposing to discontinue new
technology add-on payments for the
Zilver® PTX® for FY 2016. We are
inviting public comments on this
proposal.
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f. CardioMEMSTM HF (Heart Failure)
Monitoring System
CardioMEMS, Inc. submitted an
application for new technology add-on
payment for FY 2015 for the
CardioMEMSTM HF (Heart Failure)
Monitoring System, which is an
implantable hemodynamic monitoring
system comprised of an implantable
sensor/monitor placed in the distal
pulmonary artery. Pulmonary artery
hemodynamic monitoring is used in the
management of heart failure. The
CardioMEMSTM HF Monitoring System
measures multiple pulmonary artery
pressure parameters for an ambulatory
patient to measure and transmit data via
a wireless sensor to a secure Web site.
The CardioMEMSTM HF Monitoring
System utilizes radiofrequency (RF)
energy to power the sensor and to
measure pulmonary artery (PA) pressure
and consists of three components: An
Implantable Sensor with Delivery
Catheter, an External Electronics Unit,
and a Pulmonary Artery Pressure
Database. The system provides the
physician with the patient’s PA pressure
waveform (including systolic, diastolic,
and mean pressures) as well as heart
rate. The sensor is permanently
implanted in the distal pulmonary
artery using transcatheter techniques in
the catheterization laboratory where it is
calibrated using a Swan-Ganz catheter.
PA pressures are transmitted by the
patient at home in a supine position on
a padded antenna, pushing one button
which records an 18-second continuous
waveform. The data also can be
recorded from the hospital, physician’s
office or clinic.
The hemodynamic data, including a
detailed waveform, are transmitted to a
secure Web site that serves as the
Pulmonary Artery Pressure Database, so
that information regarding PA pressure
is available to the physician or nurse at
any time via the Internet. Interpretation
of trend data allows the clinician to
make adjustments to therapy and can be
used along with heart failure signs and
symptoms to adjust medications.
The applicant believed that a large
majority of patients receiving the sensor
would be admitted as an inpatient to a
hospital with a diagnosis of acute or
chronic heart failure, which is typically
described by ICD–9–CM diagnosis code
428.43 (Acute on chronic combined
systolic and diastolic heart failure) and
the sensor would be implanted during
the inpatient stay. The applicant stated
that for safety considerations, a small
portion of these patients may be
discharged and the sensor would be
implanted at a future date in the
hospital outpatient setting. In addition,
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there would likely be a group of patients
diagnosed with chronic heart failure
who are not currently hospitalized, but
who have been hospitalized in the past
few months for which the treating
physician believes that regular
pulmonary artery pressure readings are
necessary to optimize patient
management. Depending on the
patient’s status, the applicant stated that
these patients may have the sensor
implanted in the hospital inpatient or
outpatient setting.
The applicant received FDA approval
on May 28, 2014. The CardioMEMSTM
HF Monitoring System is currently
described by ICD–9–CM procedure code
38.26 (Insertion of implantable pressure
sensor without lead for intracardiac or
great vessel hemodynamic monitoring).
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology payments for
the CardioMEMSTM HF Monitoring
System and consideration of the public
comments we received in response to
the FY 2015 IPPS/LTCH PPS proposed
rule, we approved the CardioMEMSTM
HF Monitoring System for new
technology add-on payments for FY
2015 (79 FR 49940). Cases involving the
CardioMEMSTM HF Monitoring System
that are eligible for new technology addon payments are identified by ICD–9–
CM procedure code 38.26 (Insertion of
implantable wireless pressure sensor for
intracardiac or great vessel
hemodynamic monitoring), which was
effective October 1, 2011. With the new
technology add-on payment application,
the applicant stated that the total
operating cost of the CardioMEMSTM HF
Monitoring System is $17,750. Under
§ 412.88(a)(2), new technology add-on
payments are limited to the lesser of 50
percent of the average cost of the device
or 50 percent of the costs in excess of
the MS–DRG payment for the case. As
a result, the maximum new technology
add-on payment for a case involving the
CardioMEMSTM HF Monitoring System
is $8,875.
With regard to the newness criterion
for the CardioMEMSTM HF Monitoring
System, we considered the beginning of
the newness period to commence when
the CardioMEMSTM HF Monitoring
System was approved by the FDA on
May 28, 2014. Because the 3-year
anniversary date of the entry of the
CardioMEMSTM HF Monitoring System
on the U.S. market will occur in FY
2017 (May 28, 2017), we are proposing
to continue new technology add-on
payments for this technology for FY
2016. We are inviting public comments
on this proposal.
Because we are adopting the ICD–10
coding system, effective October 1,
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2015, as discussed in section II.G.1.a. of
the preamble of this proposed rule, for
FY 2016, we are proposing to identify
and make new technology add-on
payments for cases involving the
CardioMEMSTM HF Monitoring System
using either ICD–10–PCS procedure
code 02HQ30Z (Insertion of pressure
sensor monitoring device into right
pulmonary artery, percutaneous
approach) or ICD–10–PCS procedure
code 02HR30Z (Insertion of pressure
sensor monitoring device into left
pulmonary artery, percutaneous
approach). The maximum payment for a
case involving the CardioMEMSTM HF
Monitoring System would remain at
$8,875 for FY 2016. We are inviting
public comments on this proposal.
g. MitraClip® System
Abbott Vascular submitted an
application for new technology add-on
payments for the MitraClip® System for
FY 2015. The MitraClip® System is a
transcatheter mitral valve repair system
that includes a MitraClip® device
implant, a Steerable Guide Catheter, and
a Clip Delivery System. It is designed to
perform reconstruction of the
insufficient mitral valve for high-risk
patients who are not candidates for
conventional open mitral valve repair
surgery.
Mitral regurgitation (MR), also
referred to as mitral insufficiency or
mitral incompetence, occurs when the
mitral valve fails to close completely
causing the blood to leak or flow
backwards (regurgitate) into the left
ventricle. If the amount of blood that
leaks backwards into the left ventricle is
minimal, then intervention is usually
not necessary. However, if the amount
of blood that is regurgitated becomes
significant, this can cause the left
ventricle to work harder to meet the
body’s need for oxygenated blood.
Severity levels of MR can range from
grade 1+ through grade 4+. If left
untreated, severe MR can lead to heart
failure and death. The American College
of Cardiology (ACC) and the American
Heart Association (AHA) issued practice
guidelines in 2006 that recommended
intervention for moderate/severe or
severe MR (grade 3+ to 4+). The
applicant stated that the MitraClip®
System is ‘‘indicated for percutaneous
reduction of significant mitral
regurgitation . . . in patients who have
been determined to be at prohibitive
risk for mitral value surgery by a heart
team, which includes a cardiac surgeon
experienced in mitral valve surgery and
a cardiologist experienced in mitral
valve disease and in whom existing
comorbidities would not preclude the
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expected benefit from correction of the
mitral regurgitation.’’
The MitraClip® System mitral valve
repair procedure is based on the doubleorifice surgical repair technique that has
been used as a surgical technique in
open chest, arrested-heart surgery for
the treatment of MR since the early
1990s. According to the applicant, in
utilizing ‘‘the double-orifice technique,
a portion of the anterior leaflet is
sutured to the corresponding portion of
the posterior leaflet using standard
techniques and forceps and suture,
creating a point of permanent
cooptation (‘‘approximation’’) of the two
leaflets. When the suture is placed in
the middle of the valve, the valve will
have a functional double orifice during
diastole.’’
With regard to the newness criterion,
the MitraClip® System received a
premarket approval from the FDA on
October 24, 2013. The MitraClip®
System is indicated ‘‘for the
percutaneous reduction of significant
symptomatic mitral regurgitation (MR
>= 3+) due to primary abnormality of
the mitral apparatus (degenerative MR)
in patients who have been determined
to be at prohibitive risk for mitral valve
surgery by a heart team, which includes
a cardiac surgeon experienced in mitral
valve surgery and a cardiologist
experienced in mitral valve disease, and
in whom existing comorbidities would
not preclude the expected benefit from
reduction of the mitral regurgitation.’’
The MitraClip® System became
immediately available on the U.S.
market following FDA approval. The
MitraClip® System is a Class III device,
and has an investigational device
exemption (IDE) for the EVEREST study
(Endovascular Valve Edge-to-Edge
Repair Study)—IDE G030061, and for
the COAPT study (Cardiovascular
Outcomes Assessment of the MitraClip
Percutaneous Therapy for Health
Failure Patients with Functional Mitral
Regurgitation)—IDE G120024. Effective
October 1, 2010, ICD–9–CM procedure
code 35.97 (Percutaneous mitral valve
repair with implant) was created to
identify and describe the MitraClip®
System technology.
On August 7, 2014, CMS issued a
National Coverage Decision (NCD)
concerning Transcatheter Mitral Valve
Repair procedures. We refer readers to
the CMS Web site at: https://
www.cms.gov/medicare-coveragedatabase/details/nca-trackingsheet.aspx?NCAId=273 for information
related to this NCD.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology payments for
the MitraClip® System and
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consideration of the public comments
we received in response to the FY 2015
IPPS/LTCH PPS proposed rule, we
approved the MitraClip® System for
new technology add-on payments for FY
2015 (79 FR 49946). As discussed in the
FY 2015 IPPS/LTCH PPS final rule, this
approval is on the basis of using the
MitraClip® consistent with the NCD.
Cases involving the MitraClip® System
that are eligible for the new technology
add-on payments are currently
identified by ICD–9–CM procedure code
35.97. The average cost of the
MitraClip® System is reported as
$30,000. Under section 412.88(a)(2),
new technology add-on payments are
limited to the lesser of 50 percent of the
average cost of the device or 50 percent
of the costs in excess of the MS–DRG
payment for the case. As a result, the
maximum new technology add-on
payment for a case involving the
MitraClip® System is $15,000 for FY
2015.
With regard to the newness criterion
for the MitraClip® System, we
considered the beginning of the
newness period to commence when the
MitraClip® System was approved by the
FDA on October 24, 2013. Because the
3-year anniversary date of the entry of
the MitraClip® System on the U.S.
market will occur in FY 2017 (October
24, 2016), we are proposing to continue
new technology add-on payments for
this technology for FY 2016. We are
inviting public comments on this
proposal.
Because we are adopting the ICD–10
coding system, beginning October 1,
2015, as discussed in section II.G.1.a, of
the preamble of this proposed rule, for
FY 2016, we are proposing to identify
and make new technology add-on
payments for cases involving the
MitraClip® System using ICD–10–PCS
procedure code 02UG3JZ (Supplement
mitral valve with synthetic substitute,
percutaneous approach). The maximum
payment for a case involving the
MitraClip® System would remain at
$15,000 for FY 2016. We are inviting
public comments on this proposal.
h. Responsive Neurostimulator (RNS®)
System
NeuroPace, Inc. submitted an
application for new technology add-on
payments for FY 2015 for the use of the
RNS® System. (We note that the
applicant submitted an application for
new technology add-on payments for FY
2014, but failed to receive FDA approval
prior to the July 1 deadline.) Seizures
occur when brain function is disrupted
by abnormal electrical activity. Epilepsy
is a brain disorder characterized by
recurrent, unprovoked seizures.
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According to the applicant, the RNS®
System is the first implantable medical
device (developed by NeuroPace, Inc.)
for treating persons diagnosed with
epilepsy whose partial onset seizures
have not been adequately controlled
with antiepileptic medications. The
applicant further stated that, the RNS®
System is the first closed-loop,
responsive system to treat partial onset
seizures. Responsive electrical
stimulation is delivered directly to the
seizure focus in the brain when
abnormal brain activity is detected. A
cranially implanted programmable
neurostimulator senses and records
brain activity through one or two
electrode-containing leads that are
placed at the patient’s seizure focus/
foci. The neurostimulator detects
electrographic patterns previously
identified by the physician as abnormal,
and then provides brief pulses of
electrical stimulation through the leads
to interrupt those patterns. Stimulation
is delivered only when abnormal
electrocorticographic activity is
detected. The typical patient is treated
with a total of 5 minutes of stimulation
a day. The RNS® System incorporates
remote monitoring, which allows
patients to share information with their
physicians remotely.
With respect to the newness criterion,
the applicant stated that some patients
diagnosed with partial onset seizures
that cannot be controlled with
antiepileptic medications may be
candidates for the vagus nerve
stimulator (VNS) or for surgical removal
of the seizure focus. According to the
applicant, these treatments are not
appropriate for, or helpful to, all
patients. Therefore, the applicant
believed that there is an unmet clinical
need for additional therapies for partial
onset seizures. The applicant further
stated that the RNS® System addresses
this unmet clinical need by providing a
novel treatment option for treating
persons diagnosed with medically
intractable partial onset seizures. The
applicant received FDA premarket
approval on November 14, 2013.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology payments for
the RNS® System and consideration of
the public comments we received in
response to the FY 2015 IPPS/LTCH
PPS proposed rule, we approved the
RNS® System for new technology addon payments for FY 2015 (79 FR 49950).
Cases involving the RNS® System that
are eligible for new technology add-on
payments are currently identified using
the following ICD–9–CM procedure
codes: 01.20 (Cranial implantation or
replacement of neurostimulator pulse
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generator) in combination with 02.93
(Implantation or replacement of
intracranial neurostimulator lead(s)).
According to the applicant, cases using
the RNS® System would incur an
anticipated cost per case of $36,950.
Under § 412.88(a)(2) of the regulations,
new technology add-on payments are
limited to the lesser of 50 percent of the
average costs of the device or 50 percent
of the costs in excess of the MS–DRG
payment rate for the case. As a result,
the maximum new technology add-on
payment for cases involving the RNS®
System is $18,475.
With regard to the newness criterion
for the RNS® System, we considered the
beginning of the newness period to
commence when the RNS® System was
approved by the FDA on November 14,
2013. Because the 3-year anniversary
date of the entry of the RNS® System on
the U.S. market will occur in FY 2017
(November 14, 2016), we are proposing
to continue new technology add-on
payments for this technology for FY
2016. We are inviting public comments
on this proposal.
Because we are adopting the ICD–10
coding system effective October 1, 2015,
as discussed in section II.G.1.a. of the
preamble of this proposed rule, we are
proposing to identify and make new
technology add-on payments for cases
involving the RNS® System using the
following ICD–10–PCS procedure code
combination: 0NH00NZ (Insertion of
neurostimulator generator into skull,
open approach) in combination with
00H00MZ (Insertion of neurostimulator
lead into brain, open approach). The
maximum payment for a case involving
the RNS® System would remain at
$18,475 for FY 2016. We are inviting
public comments on this proposal.
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5. FY 2016 Applications for New
Technology Add-On Payments
We received applications for nine
new technology add-on payments for FY
2016. In accordance with the regulations
under § 412.87(c), applicants for new
technology add-on payments must have
FDA approval by July 1 of each year
prior to the beginning of the fiscal year
that the application is being considered.
A discussion of the applications is
presented below.
a. Angel Medical Guardian® Ischemic
Monitoring Device
Angel Medical Systems, Inc.
submitted an application for new
technology add-on payments for the
Angel Medical Guardian® Ischemic
Monitoring Device (hereinafter referred
to as the Guardian®). The Guardian®
implantable ischemia detection system
is designed to provide early detection
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and patient alerts for ischemic and other
cardiac events experienced by
ambulatory patients. The device
consists of an implantable monitoring
device (IMD) that communicates with
an external device (EXD) via telemetry.
The IMD monitors the patient’s current
cardiac data and compares these data to
the patient’s historical baseline using
thresholds that reflect the normal
ischemic range for each individual.
Upon detection of a cardiac anomaly,
the implanted IMD vibrates and
provides one of two distinguishable
alerts, ‘‘emergency alarms’’ and ‘‘see
doctor alerts,’’ which prompt the patient
to initiate emergency and/or
preventative actions. The system also
includes a program that allows
physicians to adjust the settings for
event detection and subsequent alerts.
With respect to the newness criterion,
the applicant anticipates FDA premarket
approval during June 2015. The
Guardian® technology is a Class III
device that has obtained an
investigational device exemption (IDE)
from the FDA under IDE number
G060259. Effective October 1, 2006 (FY
2007), ICD–9–CM procedure codes
00.56 (Insertion or replacement of
implantable pressure sensor (lead) for
intracardiac hemodynamic monitoring)
and 00.57 (Implantation or replacement
of subcutaneous device for intracardiac
hemodynamic monitoring) were created
to describe specific types of cardiac
procedures. There have been minor
revisions to each of the procedure
codes’ title and description over the
years to better differentiate procedures
being performed with various
technologies. As of October 1, 2011 (FY
2012), these codes distinguish
procedures using the Guardian®
technology from other similar
procedures that use various
technologies. The current ICD–9–CM
procedure code titles are as follows:
00.56 (Insertion or replacement of
implantable pressure sensor with lead
for intracardiac or great vessel
hemodynamic monitoring), and 00.57
(Implantation or replacement of
subcutaneous device for intracardiac or
great vessel hemodynamic monitoring).
As stated earlier in section II.G.1.a. of
the preamble of this proposed rule,
effective October 1, 2015 (FY 2016), the
ICD–10 coding system will be
implemented. Under ICD–10, procedure
code 02HK32Z (Insertion of monitoring
device into right ventricle, percutaneous
approach) is the comparable translation
for ICD–9–CM procedure code 00.56,
and procedure code 0JH602Z (Insertion
of monitoring device into chest
subcutaneous tissue and fascia, open
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approach) is the comparable translation
for ICD–9–CM procedure code 00.57,
which specifically describe procedures
involving the Guardian® technology. We
note that, in accordance with
§ 412.87(c), in order for a technology to
be considered for new technology addon payments for a particular fiscal year,
the technology must be approved by the
FDA by July 1 prior to the particular
fiscal year for which add-on payments
are requested. According to the
applicant, there are no other treatment
modalities that perform the same
function as the Guardian® technology.
Therefore, the applicant believed that
the Guardian® technology is not
substantially similar to any other
currently approved technology. We are
inviting public comments on whether
the Guardian® technology meets the
newness criterion.
With respect to the cost criterion, the
applicant determined that cases
involving the Guardian® technology
map to MS–DRG 264 (Other Circulatory
System O.R. Procedures). The applicant
initially provided a sensitivity analysis
performed using all of the cases
assigned to MS–DRG 264, without
isolating a subset of cases that would be
eligible for treatment using the
Guardian® technology. In follow up to
our request for a more focused analysis
that calculates an average case-weighted
standardized charge per case for cases
involving the Guardian® technology
assigned to MS–DRG 264, the applicant
submitted a revised analysis that used
data from a subset of cases representing
patients who received treatment
involving the implantation of
pacemakers that mapped to MS–DRG
243 (Pacemaker Implant with CC). The
applicant searched the Healthcare Cost
and Utilization Project (HCUP) database
for patient profiles that indicated prior
myocardial infarction with
comorbidities such as malignant
hypertension (reported using ICD–9–CM
diagnosis code 401.0), other acute and
subacute forms of ischemic disease
(reported using ICD–9–CM diagnosis
code 411.89), and intermediate coronary
syndrome (that is, unstable angina
reported using ICD–9–CM diagnosis
code 411.1). According to the applicant,
all of the patients enrolled in the
ALERTS pivotal clinical study exhibited
at least one or more of these
comorbidities, similar to many of the
patients represented by cases assigned
to MS–DRG 243. The applicant asserted
that the results from the revised search
of the HCUP database revealed patient
profiles that were similar to the patients
who would have likely been
recommended for treatment using the
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Guardian® technology, which are
represented by the cases assigned to
MS–DRG 264. The applicant identified
843 cases assigned to MS–DRG 243,
which represents patients treated with
pacemaker implantations by the
hospitals that participated in the
Guardian® ALERTS clinical study.
The applicant used data from
multiple sources to compute an average
case-weighted standardized charge per
case for procedures involving the
Guardian® technology. The applicant
began by determining the specific FY
2015 Medicare IPPS Federal rate for
cases assigned to MS–DRG 243 that
were treated by each hospital that
participated in the Guardian® ALERTS
clinical study. The applicant then
adjusted this amount by a factor of
1.057, which was derived from the
March 2014 MedPAC Report to
Congress on Medicare payment policies,
to convert the Medicare payment to
actual costs incurred by each hospital
for each case. Specifically, the applicant
determined this adjustment factor by
subtracting the average industry wide
margin of ¥5.4 percent, or ¥0.054
percent, for hospitals during 2012,
which was reflected in the March 2014
Report to Congress, from a factor of 1,
which results in the percentage of
inpatient costs that Medicare paid
(1¥0.054 = 94.6), and then divided this
amount by 100 (100/94.6 = 1.057). To
convert the adjusted Medicare payment
amount to charges, the applicant
applied hospital-specific CCRs found in
the FY 2015 IPPS final rule impact file.
The applicant computed an average
case-weighted standardized charge per
case by weighting the number of
implants performed using the
Guardian® technology performed by
each hospital participating in the
Guardian® ALERTS clinical study to the
overall number of implants performed
and represented by cases assigned to
MS–DRG 243. This resulted in an
average case-weighted standardized
charge per case of $75,010. The
applicant then deducted device-related
charges for a pacemaker based on data
obtained from the FY 2015 After
Outliers Removed (AOR) File to
determine the nonimplant resources
used during these types of procedures,
and added the device-related charges for
the Guardian® technology, which
resulted in an adjusted average caseweighted charge per case of $89,050.
Because this adjusted average caseweighted standardized charge per case
exceeds the average case-weighted
threshold amount of $65,544 for MS–
DRG 264 as displayed in Table 10 of the
FY 2015 IPPS/LTCH PPS final rule, the
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applicant maintained that the
Guardian® technology meets the cost
criterion.
We have several concerns regarding
the applicant’s cost analysis. We do not
believe that it is appropriate to convert
Medicare payments for discharges to
actual costs incurred by hospitals by
applying a margin adjustment factor and
hospital-specific CCRs to determine an
average case-weighted standardized
charge for specific cases. According to
the regulations under 42 CFR
412.2(b)(1), the prospective payment
amount paid for inpatient hospital
services is the total Medicare payment
for the inpatient operating costs and the
inpatient capital-related costs incurred
in furnishing services covered by the
Medicare program. The prospective
payment amount represents a payment
amount for the total cost of inpatient
hospital services incurred by hospitals
participating in the Medicare program,
but does not represent a measure of the
actual costs per case. For example, two
hospitals in the same CBSA will be paid
the same prospective payment amount
for a case assigned to the same MS–
DRG. The fact that these hospitals are
paid the same prospective payment
amount does not imply that the
hospitals incurred the same amount of
costs per case. On the contrary, the
hospitals probably incurred very
different costs for each case and the
prospective payment amount is simply
a payment for the inpatient costs
covered by Medicare. Therefore, we are
concerned about the methodology used
by the applicant to determine an average
case-weighted standardized charge per
case, and do not believe that the
calculation of this amount determined
by the applicant is accurate. Moreover,
we are concerned that the applicant
assumed that the patient profiles for
patient treated with pacemaker
implantations and patients treated using
the Guardian® technology are similar
enough to warrant the inclusion of cases
assigned to MS–DRG 243 in the analysis
and then to depend upon the results of
that analysis as a basis to demonstrate
that the technology meets the cost
criterion. In addition, we do not believe
that it is appropriate to assume that the
resources used during procedures
involving pacemaker implantations and
procedures involving the Guardian®
technology would be the same, and the
applicant does not provide a rationale
for assuming such similarities. Because
of these concerns, we are unable to
determine if the technology meets the
cost criterion. We are inviting public
comments on whether the Guardian®
technology meets the cost criterion,
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particularly with respect to the concerns
we have raised.
With respect to the substantial
clinical improvement criterion, the
applicant asserted that this technology
provides a more rapid beneficial
resolution to ischemic and other cardiac
events in ambulatory patients that
reduces mortality and morbidity, and
facilitates a faster patient presentation
time to initiate treatment for these types
of disorders. The applicant also believed
that this technology fulfills an unmet
clinical need for early diagnoses and
preventative treatment options for a
patient population that experiences
silent, asymptomatic ischemia. The
applicant included data from its pivotal
ALERTS clinical trial, a randomized
study expanding over a 6-month period
of patients who were treated using the
Guardian® technology and with the
alarm function turned on (which
represented the treatment group) or the
alarm function turned off (which
represented the control group). The
primary efficacy endpoint was a
composite variable that considered
cardiac or unexplained death, new
death Q-wave MI, or delayed
presentation (time to door >2 hours) for
a documented coronary occlusion event.
The primary safety outcome measure
was device-related complications.
According to the applicant, the
following findings demonstrate that the
Guardian® technology represents a
substantial clinical improvement in
regard to currently available treatment
options for Medicare beneficiaries:
• The treatment group showed
statistically significant clinical
improvement over the control group
using a composite outcome variable;
• 97 percent of patients treated with
implantations using the Guardian®
technology were free from systemrelated complications at 6 months post
programming;
• A reduced proportion of patients
having pre-hospital delays over 2 hours
for a confirmed thrombotic coronary
occlusive event;
• A reduction in the median time-todoor for patients treated using the
Guardian® technology alert system
turned on (51 minutes) versus patients
treated using the Guardian® technology
alert system turned off (1,808 minutes);
and
• An improvement in the overall
quality of life, and greater control over
the condition, including feeling safer,
for patients who were enrolled in the
ALERTS trial and participated in a 2012
quality of life study that were treated
with the Guardian® technology when
the alarm system was activated.
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We are concerned that the outcome
measures, including the quality of life
measures, are based on and reflective of
factors other than the efficacy of the
device. For instance, any benefit from
using the Guardian® technology
depends entirely upon the patient
heeding the alarms and alerts and
seeking emergency medical care without
delay. Moreover, we are concerned that
the ALERTS pivotal trial uses inherently
different methods of ascertainment of
‘‘delayed presentation’’ for the treatment
group and the control group after an
ischemic event, which implies a serious
bias in regard to the clinical trial results.
We believe that this bias questions the
validity of the primary efficacy
endpoint. An additional concern is that
the ALERTS pivotal trial uses a very
broad definition of a ‘‘confirmed
thrombotic event.’’ Although the pivotal
trial used four different criteria to
determine whether such an event
occurred, only two of them are actually
evidence of an acute coronary event for
which timely patient presentation for
medical care might improve outcomes.
The applicant did indicate how many
confirmed events met each of the four
criteria.
We are inviting public comments on
if, and how, the Guardian® technology
meets the substantial clinical
improvement criterion, particularly
with respect to the concerns we have
raised.
Below we summarize and respond to
the comments submitted on the
Guardian® technology at the Town Hall
meeting.
Comment: Several participants in the
ALERTS clinical trial submitted
comments supporting the approval of
new technology add-on payments for
the Guardian® technology. According to
the commenters, use of the Guardian®
technology is associated with
substantial clinical improvement of
patients at high risk for a repeat
myocardial infarction. The commenters
stated that experiences as part of the
ALERTS study have been positive. In
addition, the commenters agreed with
the applicant that patients implanted
with an active Guardian® device who
were alerted to a confirmed myocardial
infarction event arrived at a medical
facility significantly faster than those
generally treated using the regular
standard of care. Moreover, the
commenters agreed with the applicant
that patients are reassured by the
effectiveness of the Guardian® device as
a means of monitoring and protection.
The commenters believed that the
Guardian® device provides patients and
providers with an important tool for
helping to recognize when a significant
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ischemic event occurs and when to seek
prompt medical treatment, which result
in reduced morbidity and mortality,
fewer visits to the emergency room and
unnecessary hospitalizations, and
reduced health care expenditures. The
commenters believed that the
Guardian® device meets the substantial
clinical improvement criterion because
the device offers a more rapid and
beneficial resolution for treating
patients by its capability to diagnose a
medical condition in a patient
population where the condition is
currently undetectable as well as offers
a treatment option to a patient
population unresponsive to currently
available treatments.
One commenter, a principal
investigator in the ALERTS study,
further reported that treatment using the
Guardian® device tended to reduce the
incidence of Q waves, a primary clinical
endpoint that has important
ramifications in both morbidity and
mortality rates. The commenter also
noted that, based on the results of the
ALERTS study, asymptomatic
thrombotic events were recognized in 21
of 451 (4.6 percent) of patients in the
Guardian® treatment arm, and that the
vast majority of these patients arrived to
a medical facility within an hour of the
onset of the event. In contrast, patients
in the control arm who experienced
asymptomatic ischemic events recorded
by the Guardian® device arrived to a
medical facility between 10 and 77 days
after the event. According to the
commenter, many of these patients
experienced a silent myocardial
infarction, which occurs over time in a
significant number of patients and can
lead to higher mortality rates. The
commenter believed that the Guardian®
device provides a significant benefit to
a patient population that experiences
asymptomatic ischemic events and does
not receive any physical warnings of
their condition, and who would
otherwise not seek treatment for a
longer period of time than what is
recommended in the medical
community, if treatment is sought at all.
Another commenter provided
additional information on the
opportunity for improvement upon time
to treatment for patients at high risk for
a recurrent myocardial infarction, which
would in turn lead to improved clinical
outcomes, particularly for the patient
population experiencing asymptomatic
ischemia. According to the commenter,
approximately 50 percent of patients
experiencing myocardial infarction have
no symptoms at all or symptoms that
may not be recognized, and often do not
receive any acute therapy to avert or
mitigate the impact of the infarction.
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The commenter stated that the current
standard of care requires patients to
recognize symptoms of heart attack and
seek medication immediately, and, for
every 30 minute delay in treatment,
there is an associated 8.5 percent
increased risk of developing an ejection
fraction of less than 30 percent, which
is highly correlated with subsequent
heart failure, and an associated 7.5
percent relative risk increase in 1 year
mortality. Therefore, the commenter
believed that the Guardian® device
presents a significant opportunity to
address improvement in the timing of
treatment for patients at high risk for a
recurrent myocardial infarction.
Response: We appreciate the
commenters’ input. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payments for the
Guardian® device.
b. Blinatumomab (BLINCYTOTM)
Amgen, Inc. submitted an application
for new technology add-on payments for
Blinatumomab (BLINCYTOTM), a bispecific T-cell engager (BiTE) used for
the treatment of Philadelphia
chromosome-negative (Ph-) relapsed or
refractory (R/R) B-cell precursor acutelymphoblastic leukemia (ALL), which is
a rare aggressive cancer of the blood and
bone marrow. Approximately 6,050
individuals are diagnosed with ALL in
the United States each year, and
approximately 2,400 individuals, which
represents 30 percent of all new cases,
are adults. ALL occurs when there are
malignant transformations of B-cell or
T-cell progenitor cells, causing an
accumulation of lymphoblasts in the
blood, bone marrow, and occasionally
throughout the body. As a bi-specific Tcell engager, the BLINCYTOTM
technology attaches to a molecule on the
surface of the tumorous cell, as well as
to a molecule on the surface of normal
T-cells, bringing the two into closer
proximity and allowing the normal Tcell to destroy the tumorous cell.
Specifically, the BLINCYTOTM
technology attaches to a cell identified
as CD19, which is present on all of the
cells of the malignant transformations
that cause ALL and helps attract the cell
into close proximity of the T-cell CD3
with the intent of getting close enough
to allow the T-cell to inject toxins that
destroy the cancerous cell.
BLINCYTOTM is administered as a
continuous IV infusion delivered at a
constant flow rate using an infusion
pump. A single cycle of treatment
consists of 28 days of continuous
infusion, and each treatment cycle
followed by 2 weeks without treatment
prior to administering any further
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treatments. A course of treatment
consists of two phases. Phase 1 consists
of initial inductions or treatments
intended to achieve remission followed
by additional inductions and treatments
to maintain consolidation; or treatments
given after remission has been achieved
to prolong the duration. During phase 1
of a single treatment course, up to two
cycles of BLINCYTOTM are
administered, and up to three additional
cycles are administered during
consolidation. The recommended
dosage of BLINCYTOTM administered
during the first cycle of treatment is 9
mcg per day for the first 7 days of
treatment. The dosage is then increased
to 28 mcg per day for 3 weeks until
completion. During phase 2 of the
treatment course, all subsequent doses
are administered as 28 mcg per day
throughout the entire duration of the 28day treatment period.
With respect to the newness criterion,
the BLINCYTOTM technology received
FDA approval on December 3, 2014, for
the treatment of patients diagnosed with
Ph- R/R B-cell precursor ALL, and the
product gained entry onto the U.S.
market on December 17, 2014. As stated
in section II.G.1.a. of the preamble of
this proposed rule, effective October 1,
2015 (FY 2016), the ICD–10 coding
system will be implemented. We note
that the applicant submitted a request
for unique ICD–10–PCS codes that was
presented at the March 18, 2015 ICD–10
Coordination and Maintenance
Committee meeting. If approved, the
codes will be effective on October 1,
2015 (FY 2016). More information on
this request can be found on the CMS
Web site located at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
According to the applicant, the
BLINCYTOTM technology is the first,
and the only, bi-specific CD19-directed
CD3 T-cell engager single-agent
immunotherapy approved by the FDA.
However, we are concerned that
BLINCYTOTM may be substantially
similar to other bi-specific T-cell
engagers. In the FY 2010 IPPS/RY 2010
LTCH PPS final rule (74 FR 43813
through 43814), we established criteria
for evaluating whether a new
technology is substantially similar to an
existing technology, specifically: (1)
Whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome; (2) whether a
product is assigned to the same or a
different MS–DRG; and (3) whether the
new use of the technology involves the
treatment of the same or similar type of
disease and the same or similar patient
population. If a technology meets all
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three of these criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments. For a
detailed discussion of the criteria for
substantial similarity, we refer readers
to the FY 2006 IPPS final rule (70 FR
47351 through 47352), and the FY 2010
IPPS/LTCH PPS final rule (74 FR 43813
through 43814).
With regard to the first criterion, we
are concerned that the mechanism of
action of the BLINCYTOTM technology
does not appear to differ from those of
other bi-specific T-cell engagers, which
also attract the cancerous cell within
close proximity of a normal T-cell with
the intent of allowing the cell to get
close enough to inject toxins to destroy
the cancerous cell. There are several
other BiTEs currently under
investigation, including MT110 that are
used for the treatment of patients
diagnosed with gastrointestinal and
lung cancers and are directed towards
the EpCAM antigen, as well as MCSPspecific and CD33-specific BiTEs used
for treating patients diagnosed with
melanoma and acute myeloid leukemia,
respectively. We believe that the feature
that distinguishes the BLINCYTOTM
technology from these other bi-specific
T-cell engagers is that it specifically
targets the CD19 cell. However, we are
concerned that the specificity of the
mechanism of action may not be
sufficient to distinguish the
BLINCYTOTM technology from other bispecific T-cell engagers and, therefore,
the technology bears substantial
similarity to these other BiTEs used as
current treatment options for Medicare
beneficiaries. Further, we are concerned
that determining that the BLINCYTOTM
technology meets the newness criterion
based on the specificity of the
mechanism of action would set a
precedent that a drug employing the
same mechanism of action could be
considered ‘‘new’’ based on such
specificity when evaluated under the
substantial similarity criterion.
With respect to the second criterion,
the applicant maintained that ICD–9–
CM diagnosis codes 204.00 (Acute
lymphoid leukemia, without mention of
having achieved remission) and 204.02
(Acute lymphoid leukemia in relapse)
are used to identify patients who may
potentially be eligible for treatment
using the BLINCYTOTM technology.
Using these diagnosis codes, the
applicant researched claims data from
the FY 2013 MedPAR file and found
cases across a wide spectrum of MS–
DRGs, not all of which are related to
acute lymphoblastic leukemia.
According to the applicant, 42.1 percent
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of all cases representing patients
diagnosed with ALL were assigned to
238 MS–DRGs. Therefore, we believe
that potential cases involving the
BLINCYTOTM technology may be
assigned to the same MS–DRG(s) as
other cases involving bi-specific T-cell
engagers used to treat patients with
leukemia.
With respect to the third criterion,
according to the applicant, the standard
treatment for patients diagnosed with
ALL currently requires the use of
multiple, intensive chemotherapy
treatment drugs in combination to
induce remission in order to allow the
patient the opportunity to proceed to
allogenic hematopoietic stem cell
transplant (alloHSCT), which is the next
stage in the course of treatment and the
only known curative option. The
applicant asserted that the
BLINCYTOTM technology is not
substantially similar to other treatment
options because it does not involve the
treatment of the same, or similar, type
of diseases or the same, or similar,
patient population. The commenter
stated that, although chemotherapy is a
successful treatment option to induce
remission in patients diagnosed with R/
R ALL, many of these patients relapse
or stop responding to this standard
treatment and, therefore, are be unable
to proceed to alloHSCT, the next stage
of treatment. Moreover, chemotherapy
toxicities can be cumulative. Therefore,
the commenter stated, patients who
have received intensive treatments may
not be eligible for further intensive
chemotherapy treatments and, therefore,
are unable to proceed to alloHSCT. The
applicant asserted that the
BLINCYTOTM technology is an anticancer immunotherapy that has shown
to be effective in the treatment of a
patient population in which
chemotherapy has not been successful.
Moreover, the applicant asserted that, as
an anti-cancer immunotherapy, the
BLINCYTOTM technology does not
demonstrate the cumulative side-effects
typically associated with chemotherapy
treatments and, therefore, is a treatment
option available to patients who are not
eligible for further chemotherapy
treatments based on the risks associated
with cumulative toxicities. However, we
are concerned that this specific patient
population is not necessarily
distinguishable from the overall patient
population of individuals diagnosed
with ALL, and we are unsure how to
identify these patients using
administrative claims data.
We believe that the BLINCYTOTM
technology may be similar to other
approved technologies currently
available to treat the same patient
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population and medical disorders and,
therefore, may not meet the newness
criterion. In addition, we do not believe
that the specific patient population
targeted by the applicant is sufficiently
distinguishable from the overall patient
population that may be eligible for
treatment using options that are
currently available for these types of
medical disorders. We are seeking
public comments on if, and how, the
BLINCYTOTM technology meets the
newness criterion.
With respect to the cost criterion, the
applicant researched claims data in the
FY 2013 MedPAR file, which contained
inpatient hospital discharges from
October 1, 2012, to September 30, 2013,
and identified cases reporting ICD–9–
CM diagnosis codes 204.00 (Acute
lymphoid leukemia, without mention of
having achieved remission) and 204.02
(Acute lymphoid leukemia in relapse),
which represent patients who may
potentially be eligible for treatment
using the BLINCYTOTM technology. The
applicant found 2,649 cases across 246
MS–DRGs, including MS–DRGs 834
through 836 (Acute Leukemia without
Major Operating Room Procedure, with
MCC, with CC, and without CC/MCC,
respectively) and MS–DRGs 837 through
839 (Chemotherapy with Acute
Leukemia as Secondary Diagnosis, with
MCC, with CC, and without CC/MCC,
respectively), which represent
approximately 48.1 percent of all cases
with patients diagnosed with ALL. The
applicant also found that MS–DRG 809
(Major Hematological and Immunologic
Diagnoses Except Sickle Cell Crisis and
Coagulations Disorders with CC) and
MS–DRG 871 (Septicema or Severe
Sepsis without Mechanical Ventilation
96+ Hours with CC) contained cases that
further represent 9.8 percent of all cases
representing patients diagnosed with
ALL. The cases assigned to the
remaining 238 MS–DRGs represent a
combined 42.1 percent of all cases
representing patients diagnosed with
ALL, with no single MS–DRG
containing cases representing more than
2.0 percent of all cases representing
patients diagnosed with ALL. The
applicant also noted that when
identifying cases that may be eligible for
the BLINCYTOTM technology, it
excluded any claims for discharges paid
by Medicare Advantage plans, as well as
any claims submitted by Medicare PPSexempt cancer hospitals.
Because the applicant was unable to
provide a single estimate of the charges
that would be avoided by using the
BLINCYTOTM technology (that is,
additional charges incurred during
treatment using other technologies), the
applicant conducted its own cost
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analysis using two scenarios for each
group of MS–DRGs. The first scenario
assumed that 50 percent of the charges
for drugs would be eliminated by using
the BLINCYTOTM technology, and the
second scenario assumed that 75
percent of the charges for drugs would
be eliminated. The applicant further
conducted sensitivity analyses for each
of the top eight MS–DRGs containing
cases eligible for the BLINCYTOTM
technology, as well as a sensitivity
analysis for all of the other MS–DRGs
outside of the top eight to which eligible
cases mapped. The applicant then
examined the average case-weighted
standardized charge per case and the
average case-weighted threshold amount
for all 2,649 cases identified during FY
2013 across all 246 MS–DRGs, and for
1,533 cases during FY 2013 across the
top 8 MS–DRGs to demonstrate that the
technology meets the cost criterion.
Under the analysis’ first scenario, 50
percent of the charges for drugs incurred
by using other technologies were
removed in order to exclude the charges
associated with the use of these
technologies. The applicant determined
an average case-weighted threshold
amount of $60,278 for the 2,649 ALL
cases in the 246 MS–DRGs identified
using the thresholds in Table 10 in the
FY 2015 IPPS/LTCH PPS final rule. The
applicant also determined an average
case-weighted standardized charge per
case of $245,006, or $184,728 above the
average case-weighted threshold
amount. For the subset of 1,533 cases
that mapped to the top 8 MS–DRGs, the
applicant determined an average caseweighted threshold amount of $65,478
using the threshold in Table 10 in the
FY 2015 IPPS/LTCH PPS final rule. The
applicant also determined an average
case-weighted standardized charge per
case of $249,354, or $183,876 above the
average case-weighted threshold
amount. Based on the applicant’s
analyses, we believe that the
BLINCYTOTM technology meets the cost
criterion under the first scenario.
Under the second scenario, the
applicant removed 75 percent of charges
for drugs incurred by using other
technologies in order to exclude the
charges associated with the use of these
technologies. The applicant determined
an average case-weighted threshold
amount of $60,278 for the 246 MS–
DRGs identified using the thresholds
from Table 10 in the FY 2015 IPPS/
LTCH PPS final rule. The applicant
determined an average case-weighted
standardized charge per case of
$239,321, or $179,043 above the average
case-weighted threshold amount. For
the subset of 1,533 cases that mapped to
the top 8 MS–DRGs, the applicant
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determined an average case-weighted
threshold amount of $65,478 using the
thresholds from Table 10 in the FY 2015
IPPS/LTCH PPS final rule. The
applicant determined an average caseweighted standardized charge per case
of $242,423, or $176,945 above the
average case-weighted threshold
amount. Based on the applicant’s
analyses, we believe that the
BLINCYTOTM meets the cost criterion
under the second scenario.
In conducting the above analyses, the
applicant summarized the charges from
the claims it identified and standardized
the charges using an unspecified data
source. The applicant then inflated all
charges from FY 2013 to FY 2015 using
the 10.4427 percent inflation factor used
by CMS to update the FY 2015 outlier
threshold. In determining the costs for
the technology per case, the applicant
also assumed that the BLINCYTOTM
technology would be administered for
28 days during each inpatient stay. The
applicant also assumed a hospital
markup of 2.0 percent, and applied this
amount to its estimated charges per
case.
We have three concerns regarding the
applicant’s methodology and
assumptions used in its cost analyses.
We are concerned that the applicant did
not specify whether it used the FY 2015
IPPS final rule impact file or another
data source to standardize the charges
per case for this technology. We also are
concerned that the applicant did not
provide a basis for the hospital markup
assumed when conducting its cost
analyses. Unless the applicant provides
this information, we are unable to
determine whether the cost of the
technology per case has been calculated
appropriately. Moreover, we are
concerned that including charges
representative of a full 28-day treatment
cycle is not appropriate for the purpose
of calculating the charges associated
with the BLINCYTOTM technology in
order to determine whether the
technology meets the cost criterion.
According to the applicant, clinical trial
data demonstrate that there are large
subsets of patients who require
inpatient care for the full 28-day
treatment cycle because of the extreme
clinical conditions relating to patients
diagnosed with ALL. However, the
applicant also conceded that only 25
percent of patients enrolled in the U.S.
clinical trial were hospitalized for the
full 28-day treatment cycle, and only 38
percent of these patients were over the
age of 65. This causes us concern
regarding whether the methodology
used by the applicant in its cost analysis
is appropriate. We are inviting public
comments on if, and how, the
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BLINCYTOTM technology meets the cost
criterion, specifically in regard to our
concerns related to the applicant’s
methodology.
With respect to the substantial
clinical improvement criterion, the
applicant asserted that the
BLINCYTOTM technology represents a
substantial clinical improvement for the
treatment of patients diagnosed with R/
R ALL because it offers a treatment
option for patients who may be
unresponsive to currently available
options for treatment, decreases the rate
of subsequent therapeutic interventions
for patients who might not have
otherwise achieved remission, and
reduces mortality. The applicant
provided data analysis results from four
sources to demonstrate that the
technology represents a substantial
clinical improvement. These sources
include a historical literature search, a
model-based meta-analysis (Study
118427), a historical comparator data
(Study 20120310), and a pivotal clinical
trial (Study MT 103–211). We
summarize the results from each of
these sources below.
• The historical literature search
revealed that superior regimens among
currently used chemotherapeutic
options result in a complete remission
rate ranging from 18.0 percent to 38.6
percent, a median overall survival rate
for patients experiencing early first
relapse (<12 months) at 4.7 months, and
a median overall survival rate for
patients experiencing second or later
relapse at 3 months. However, there are
several limitations to using recent
literature as a historical comparison for
studies relating to patients diagnosed
with R/R ALL, including differences in
patient populations or study design
characteristics across published studies,
which make it difficult to formulate
absolute comparisons with regard to
data obtained from the BLINCYTOTM
pivotal clinical trial. Therefore, the
applicant conducted a model-based
meta analysis (Studies 118427 and
119384), and a historical comparator
study (Study 20120310) to account for
these differences.
• In the model-based meta analysis
(MBMA), the endpoints of complete
remission (CR), duration of complete
remission (DCR), and overall survival
(OS) rate models were used to predict
the efficacy of the BLINCYTOTM
technology in cases representing
patients diagnosed with relapsed/
refractory ALL relative to patients
treated using existing therapies.
Simulations based on the MBMA for
adult patients diagnosed with relapsed/
refractory B-precursor ALL projected a
poor outcome with existing salvage
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therapies, and a significant increase in
the proportion of CR, DCR, and OS rates
in a population with the same summary
prognostic factors as those enrolled in
the BLINCYTOTM study MT103–211.
For adult patients diagnosed with
relapsed/refractory ALL who were
treated with existing salvage therapies
and having the same summary
prognostic factors as those enrolled in
the BLINCYTOTM study MT 103–211,
the projected proportion of CR was
0.121 (95 percent CI: 0.041 to 0.341), the
median DCR rate was 4.9 months (95
percent CI: 2.5 to 9.2 months), and the
median OS rate was 3.9 months (95
percent CI: 3.0 to 4.7 months). For adult
patients diagnosed with R/R ALL having
the same summary prognostic factors as
those enrolled in the BLINCYTOTM
study MT 103–211, treatment using the
BLINCYTOTM technology when
compared with existing salvage
therapies is expected to have an odds
ratio for proportion of CR of 3.50 (95
percent CI: 1.63 to 8.40), a hazard ratio
for DCR of 0.53 (95 percent CI: 0.30 to
0.89), and a hazard ratio for OS of 0.60
(95 percent CI: 0.47 to 0.76). The
applicant maintained that these results
suggest that the BLINCYTOTM
technology is associated with a reduced
mortality rate and improved clinical
outcomes when compared to standard
chemotherapy treatment options.
• A historical comparator study was
also conducted to obtain patient-level
data for standard of care treatment
options for patients experiencing early
first relapse, refractory relapse after
HSCT, and second or greater relapse in
the same patient population as targeted
in the BLINCYTOTM pivotal clinical
trial. Study 20120310 was a
retrospective pooled analysis of
historical data available from 1990 to
2014 on hematological remission and
survival rates among patients diagnosed
with Ph- R/R B-cell precursor ALL who
were treated with standard of care
therapies. The primary study endpoint
was CR following relapse or salvage
treatment; and secondary endpoints
included estimates of OS rates, RFS
rates, and the proportion of patients
receiving alloHSCT. The weighted
median OS rate for 1,112 patients based
on available data was 3.3 months (95
percent CI: 2.8 to 3.6 months) and was
calculated from the start of the last
salvage treatment or the first relapse (if
start of the last salvage date was
unavailable) until the time of death. The
weighted OS rate at 6 and 12 months
was 30 percent (95 percent CI: 27
percent to 34 percent) and 15 percent
(95 percent CI: 13 percent to 18
percent), respectively. Among the
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patients who achieved CR based on
available data (108 patients), the
weighted median RFS rate was 5.0
months (95 percent CI: 1.2 to 6.6
months). Among the 808 patients who
received alloHSCT after salvage therapy
based on available data, 18 percent (95
percent CI: 15 percent to 21 percent)
received alloHSCT following the last
line of salvage therapy, and among
patients who achieved CR, 7 percent (95
percent CI: 5 percent to 9 percent)
received alloHSCT. The applicant
maintained that these results highlight
the poor health care outcomes for
patients treated with standard
chemotherapy and that BLINCYTOTM
represents a significant improvement.
• BLINCYTOTM study MT 103–211 is
a pivotal clinical study providing
efficacy data for the BLINCYTOTM
technology used for the treatment of
adult patients diagnosed with Ph- R/R
B-cell precursor ALL. It is a phase 2,
single-arm study that included a
particularly difficult patient population
to treat consisting of patients diagnosed
with Ph- B-cell precursor ALL who
experienced either: (1) R/R after
remission during 12 months or less of
the first salvage treatment; (2) R/R after
the first salvage treatment; or (3) R/R
within 12 months after receiving
alloHSCT. The primary endpoint was
the rate of CR plus CRh within the first
2 cycles of treatment using the
BLINCYTOTM technology. The key
secondary endpoints include best
overall response within 2 cycles of
treatment using the BLINCYTOTM
technology, RFS, time of hematological
relapse, OS rates, and the proportion of
patients eligible for alloHSCT who
underwent the procedure after receiving
treatment using the BLINCYTOTM
technology. An analysis of data from the
pivotal trial showed that 40 percent of
patients treated with the BLINCYTOTM
technology who achieved CR or CRh
were able to proceed to alloHSCT. A
secondary analysis from the pivotal
study found that in patients who
achieved CR or CRh and had a minimal
residual disease assessment during the
first 2 cycles, the MRD response rate
(little or no evidence of disease even at
the molecular level) was 82.2 percent.
The applicant asserted that this finding
is significant because MRD is often a
harbinger of relapse and a poor
prognostic factor for patients diagnosed
with ALL.
We are concerned that the data
provided from the clinical studies are
not sufficient to demonstrate that the
BLINCYTOTM technology meets the
substantial clinical improvement
criterion. For example, the
BLINCYTOTM study MT 103–211 was
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not randomized or blinded, and was
comprised of a small sample group of
189 patients with a median age of 39
years. We are concerned that the sample
group studied during the clinical trial is
not appropriate to determine if the
technology represents a substantial
clinical improvement in treatment
options available for the Medicare
patient population. Moreover, we are
concerned that meaningful conclusions
cannot be drawn from the results of this
study because of the lack of a control
group.
With regard to the applicant’s
assertion that the BLINCYTOTM
technology offers a treatment option for
patients who may be unresponsive to
currently available treatment modalities,
the applicant specifically focused on
how the BLINCYTOTM technology
represents a treatment option for a
patient population in which
chemotherapy has proven to be
unsuccessful, or for whom intensive
chemotherapy treatment is not possible
because of the risks associated with
exposure to cumulative toxicities. The
applicant believed that the MBMA, the
historical comparator study, and the
BLINCYTOTM study MT 103–211,
which is a pivotal clinical trial
sufficiently isolate this patient
population in order to measure specific
health care outcomes. We agree with
this assertion. However, our concerns
with the isolated patient population are
that it is comprised of and represents a
small sample group of patients whose
age demographic is much younger than
the age demographic of eligible
Medicare beneficiaries.
The applicant also asserted that the
BLINCYTOTM technology decreases the
rate of subsequent therapeutic
interventions for patients who might not
have otherwise achieved remission. In
other words, because treatment with the
BLINCYTOTM technology appears to
increase the possibility of some patients
achieving remission, the applicant
maintained that these patients would
receive fewer therapeutic interventions
and become eligible to receive
alloHSCT. We believe that it is difficult
to determine what services and
therapeutic interventions these patients
would have required if they had not
achieved remission, and we are not
convinced that treatment using the
BLINCYTOTM technology leads to a
decrease in additional therapeutic
interventions. We also note that patients
who successfully achieve remission
proceed to alloHSCT and, therefore,
receive a different set of subsequent
therapeutic interventions.
With regard to the applicant’s
assertion that the BLINCYTOTM
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technology reduces mortality rates, we
note that the applicant did not directly
capture mortality rates as an endpoint in
the BLINCYTOTM pivotal study (MT
103–211), although mortality was
analyzed during the other three studies
that support the new technology add-on
payment application. We note that the
data and the MBMA’s results included
with the technology’s application used
an OS odds ratio as a measure of
mortality, and were developed from 18
studies published between January 1995
and December 2012. We are concerned
that relying on the results of data using
a measure of mortality that is contingent
upon studies completed in the 1990s
presents a limitation in regard to the
methodology used in the applicant’s
analysis. Advances in overall oncology
care over the past 2 decades may
invalidate the patient population
represented in these studies as a
comparison group. Therefore, we find it
difficult to attribute the reduced
mortality rate and improved clinical
outcomes revealed by these studies to
the efficacy of the BLINCYTOTM
technology.
We are inviting public comments on
if, and how, the BLINCYTOTM
technology meets the substantial
clinical improvement criterion,
specifically in regard our specified
concerns.
c. Ceftazidime Avibactam (AVYCAZ)
Cerexa, Inc., an affiliate of Actavis,
Inc., submitted an application for new
technology add-on payments for FY
2016 for Ceftazidime Avibactam
(AVYCAZ). AVYCAZ is used for the
treatment of adult patients who have
been diagnosed with complicated
urinary tract Infections (cUTIs),
including pyelonephritis and
complicated Intra-abdominal Infections
(cIAIs), for which there are limited or no
available treatment options. Although
AVYCAZ is indicated for the treatment
of patients who have been diagnosed
with cUTIs and cIAIs, the applicant
asserted that the product may also be
used in the treatment of patients
diagnosed with cUTIs and cIAIs caused
by extended-spectrum b-lactamase
(ESBL)-producing Gram-negative
pathogens, carbapenem-resistant
Enterobacteriaceae (CRE), and
multidrug-resistant (MDR)
Pseudomonas aeruginosa.
AVYCAZ is an intravenous b-lactam/
b-lactamase inhibitor combination
antibacterial drug, consisting of an antipseudomonal, Cephalosporin (also
referred to as Ceftazidime), and a blactamase inhibitor, Avibactam.
Ceftazidime is currently available and
widely used as an extended spectrum of
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Cephalosporin. However, in recent years
Cephalosporin has had diminishing
effects because of increasing levels of
antibiotic resistance in specific bacteria.
Some species of bacteria produce +lactamase enzymes, which cleave the +lactam in antibiotics such as penicillin
that have a +-lactam ring in their
structure. The +-lactamase enzymes
inactivate the antibiotic and cause the
bacteria to become resistant to that
antibiotic. To avoid development of
resistance, in current practices +lactamase inhibitors are administered in
combination with +-lactam antibiotics to
inhibit the action of +-lactamase
enzymes and prevent the development
of antibiotic resistance because +lactamase inhibitors block the activity of
+-lactamase enzymes. This tends to
widen the spectrum of antibacterial
activity. For example, a commonly used
b-lactamase inhibitor, Clavulanic acid or
Clavulanate, is usually combined with
Amoxicillin to create Augmentin or
Ticarcillin (Timentin); Sulbactam (also a
commonly used +-lactamase inhibitor)
is usually combined with Ampicillin to
create Cefoperazone; and Tazobactam is
usually combined with Piperacillin.
Ceftazidime is not combined with any
b-lactamase inhibitors. Combining
Ceftazidime with Avibactam prohibits
bacteria from developing resistance to
the antibiotic and protects Ceftazidime
from being inactivated by b-lactamase
enzymes. According to the applicant,
unlike other inhibitors, Avibactam does
not induce Class C enzymes that
diminish the activity of Cephalosporin.
Administering Ceftazidime in
combination with Avibactam decreases
the minimum inhibitory concentration
(MIC) of Class A and Class C isolates,
and some Class D isolates, thereby
restoring the in vitro activity of
Ceftazidime against these resistant
isolates.
AVYCAZ is administered as a
treatment to patients 18 years of age, or
older, who have been diagnosed with a
cUTI and/or a cIAI in doses of 2.5g (2g
of Ceftazidime and 0.5g of Avibactam),
every 8 hours by intravenous infusion
spanning over a 2-hour time period. The
recommended duration of treatment
with AVYCAZ for patients diagnosed
with a cIAI (used in combination with
Metronidazole) is 5 to 14 days as an
inpatient. The recommended duration
of treatment with AVYCAZ for patients
diagnosed with a cUTI is 7 to 14 days
as an inpatient. The FDA has authorized
a randomized multi-center, activecontrolled trial to evaluate the safety
and tolerability of AVYCAZ in children
who are at least 3 months of age, and in
adults 18 years of age or older who have
been diagnosed with a cUTI and/or cIAI
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as part of the post-marketing
surveillance studies. The FDA also
authorized and recommended a clinical
trial to study the use of AVYCAZ in the
treatment of patients who have been
diagnosed with a cIAI and to generate
phase 3 data as an effort to evaluate the
pharmacokinetics, safety, and clinical
outcomes of adult patients diagnosed
with baseline renal impairment
(creatinine clearance of 50 mL/min or
less) who also are eligible for, or being
treated with, AVYCAZ—adjusting
dosage regimens to protect renal
function.
With regard to the newness criterion,
AVYCAZ was approved by the FDA on
February 25, 2015. As stated earlier in
section II.G.1.a. of the preamble of this
proposed rule, for FY 2016, effective
October 1, 2015 (FY 2016), the ICD–10
coding system will be implemented. We
note that the applicant submitted a
request and presented at the September
2014 Coordination and Maintenance
Committee Meeting to apply for ICD–
10–PCS codes that uniquely identify the
administration of CeftazidimeAvibactam Anti-infective. More
information on this request can be
found on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
Currently, ICD–10–PCS procedure
codes 3E03329 (Introduction of other
anti-infective into peripheral vein,
percutaneous approach) and 3E04329
(Introduction of other anti-infective into
central vein, percutaneous approach)
describe the injection of an antibiotic.
However, these ICD–10–PCS codes are
not specific to the type of antibiotic
used. We received public comments
during and after the March 2015 ICD–
10 Coordination and Maintenance
Committee meeting that supported the
creation of a unique code to identify the
AVYCAZ antibiotic when it is used in
the treatment of patients who have been
diagnosed with cUTIs and cIAIs. As a
result, the following ICD–10–PCS codes
were created under the new Section X
to describe the specific use of AVYCAZ
and are effective October 1, 2015 (FY
2016): XW03321 (Introduction of
ceftazidime-avibactam anti-infective
into peripheral vein, percutaneous
approach, new technology group 1); and
XW04321 (Introduction of ceftazidimeavibactam anti-infective into central
vein, percutaneous approach, new
technology group 1). If the AVYCAZ
technology is approved for new
technology add-on payments, we
believe that the newness period would
begin on February 25, 2015, the date of
FDA approval. At this time, the
applicant has not submitted any
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information that suggests the technology
was not available on the U.S. market as
of the FDA approval date. The applicant
maintained that AVYCAZ meets the
newness criterion. We are inviting
public comments on whether AVYCAZ
meets the newness criterion.
According to the applicant, the most
current guidelines recommend
treatment for patients hospitalized
because of a cUTI diagnosis using
antibiotic drugs such as Cefepime,
Ceftriaxone, and Piperacillin/
Tazobactam.6 For patients who have
been diagnosed with a cIAI and who are
advanced in age, the most current
guidelines recommend treatment using
antibiotic drugs such as
Imipenemcilastin, Meropenem, and
Piperacillin/Tazobactam.7 We are
concerned that AVYCAZ may be
substantially similar to other currently
available treatment options, which also
are used in the treatment of these types
of infections. In the FY 2010 IPPS/RY
2010 LTCH PPS final rule (74 FR 43813
through 43814), we established criteria
for evaluating whether a new
technology is substantially similar to an
existing technology, specifically: (1)
Whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome; (2) whether a
product is assigned to the same or a
different MS–DRG; and (3) whether the
new use of the technology involves the
treatment of the same or similar type of
disease and the same or similar patient
population. If a technology meets all
three of these criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
As stated by the applicant,
Ceftazidime is currently available and
widely used in the treatment of these
types of infections. In addition, the
current treatment options available to
Medicare beneficiaries and used to treat
this patient population include
antibiotics such as Polymyxins (for
example, Colistin), Aminoglycosides
(for example, Amikacin and
Gentamicin), Carbapenems (for
example, Meropenem and Imipenem/
Cilastatin), or Tigecycline. The
applicant maintained that the
administration of Ceftazidime in
combination with Avibactam broadens
6 Drugs for urinary tract infections. JAMA.
2014;311(8):855–6. Available at: https://
jama.jamanetwork.com/
article.aspx?articleid=1832532.
7 Solomkin JS et al. Guidelines by the Surgical
Infection Society and the Infectious Diseases
Society of America. Clin Infect Dis. 2010;50(2):133–
64. Available at: https://cid.oxfordjournals.org/
content/50/2/133.full.
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the spectrum of +-lactamase inhibition
when compared to administering
Ceftazidime without Avibactam and
other currently available therapies
because Avibactam has inhibiting agents
that restore the in vitro activity of
Ceftazidime that is sometimes decreased
when encountered by common Class A
and Class C isolates and some Class D
isolates. The applicant also asserted that
the technology may be used to treat
patients who have been diagnosed with
cUTIs and/or cIAIs caused by extendedspectrum b-lactamase (ESBL)-producing
Gram-negative pathogens, Klebsiella
pneumoniae carbapenemase (KPC),
carbapenem-resistant Enterobacteriaceae
(CRE), and multidrug-resistant (MDR)
Pseudomonas aeruginosa. However, we
believe that the mechanism of action of
AVYCAZ is the same as the mechanism
of action of Ceftazidime because both
drugs rely upon Cephalosporin to
achieve a successful therapeutic
outcome. Further, we are concerned that
AVYCAZ involves the treatment of the
same or similar type of disease and the
same or similar patient population as
other currently approved treatment
options. Therefore, we believe that
AVYCAZ bears a substantial similarity
to Ceftazidime and other currently
available treatment options. We are
inviting public comments regarding
whether AVYCAZ meets the newness
criterion, specifically with regard to the
substantial similarity criteria. For a
detailed discussion of the criteria for
substantial similarity, we refer readers
to the FY 2006 IPPS final rule (70 FR
47351 through 47352) and the FY 2010
IPPS/LTCH PPS final rule (74 FR 43813
through 43814).
With regard to the cost criterion, the
applicant maintained that AVYCAZ
meets the cost criterion. According to
the applicant, there are 63 ICD–9–CM
diagnosis codes that describe cUTIs
and/or cIAIs. Cases representing
patients who have been diagnosed with
cUTIs and/or cIAIs may be reported on
hospital claims using any 1 of 12
different ICD–9–CM diagnosis codes
describing cUTIs, and any 1 of 51 ICD–
9–CM diagnosis codes describing cIAIs.
Therefore, cases representing patients
diagnosed with either a cUTI or a cIAI
may be assigned to multiple MS–DRGs.
Of the 63 applicable ICD–9–CM
diagnosis codes, the applicant used 35
ICD–9–CM codes to identify 2,482,157
cases from the FY 2013 MedPAR file,
which mapped to 567 MS–DRGs. The
top five MS–DRGs containing cases that
may be eligible for AVYCAZ are: MS–
DRG 689 (Kidney and Urinary Tract
Infections with MCC); MS–DRG 690
(Kidney and Urinary Tract Infections
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without MCC); MS–DRG 871
(Septicemia or Severe Sepsis Without
Mechanical Ventilation 96+ Hours With
MCC); MS–DRG 872 (Septicemia or
Severe Sepsis Without Mechanical
Ventilation 96+ Hours Without MCC);
and MS–DRG 945 (Rehabilitation with
CC/MCC). The top five MS–DRGs
represent approximately 30 percent of
the cases identified (731,560 cases out
of 2,482,157 total cases), reported using
1 of the 35 respective ICD–9–CM
diagnosis codes. To demonstrate that
AVYCAZ met the cost criterion, the
applicant provided multiple analyses
for both cUTI and cIAI cases using 100
percent or 80 percent of all of the cases,
as well as analyses of subset cases
treated with low-cost generic drugs and
high-cost brand named drugs
administered for a length of 5 and 8
days.
The applicant began its analysis by
searching the FY 2013 MedPAR file and
identifying 2,183,467 cases representing
patients diagnosed with a cUTI across
544 MS–DRGs, and 298,690 cases
representing patients diagnosed with a
cIAI across 385 MS–DRGs. This resulted
in the identification of 1,146,971 cases
representing patients diagnosed with a
cUTI across 205 MS–DRGs, and 39,080
cases representing patients diagnosed
with a cIAI across 32 MS–DRGs. After
searching the FY 2013 IPPS Impact File,
the applicant focused its analysis on
1,067,111 cases representing patients
diagnosed with a cUTI across 193 MS–
DRGs and 36,181 cases representing
patients diagnosed with a cIAI across 31
MS–DRGs. The applicant further
modified a portion of its analysis to
focus on 1,067,072 cases representing
patients diagnosed with a cUTI across
192 MS–DRGs in accordance with the
thresholds obtained from Table 10 of the
FY 2015 IPPS/LTCH PPS final rule.
Based on these data, for this analysis,
the applicant used 100 percent of all of
the cases representing patients
diagnosed with a cUTI (1,067,072 cases)
across 192 MS–DRGs. The applicant
determined an average case-weighted
standardized charge per case of $42,736.
The applicant then excluded the charges
for the specific technology used from
the average case-weighted standardized
charge per case. To continue its
analysis, the applicant used two
different variables to exclude the
charges for specific technologies used,
that is, the charges for low-cost generic
drugs and the charges for high-cost
brand named drugs administered for a
length of 5 and 8 treatment days. The
applicant explained that, at a minimum,
it is recommended that antibiotics be
administered for at least 5 days to
prevent the development of antibiotic-
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resistant bacteria.8 The applicant noted
that, according to the Arlington Medical
Resources (AMR),9 the average length of
therapy for patients diagnosed with an
UTI and/or an IAI who were
successfully treated for less than 5 days
only represents 0.28 percent of all cases
representing these types of conditions.
Therefore, a 5-day treatment regimen
was selected as a basis to represent the
most conservative approach. In
addition, the AMR’s database indicated
that the average length of therapy for
patients diagnosed with an UTI who
were successfully treated was 8.3 days
and, therefore, the applicant selected a
8-day treatment regimen as a basis to
represent a more liberal approach. The
applicant also used data from the AMR
to determine which drugs are the most
commonly purchased injectable
antibiotics. The applicant estimated a
total charge of $441.75 for low-cost
generic drugs and charges related to the
infusion of these drugs for a 5-day
treatment regimen, and $706.80 for a 8day treatment regimen. The applicant
estimated a total charge of $1,535.95 for
high-cost brand named drugs and
charges related to the infusion of these
drugs for a 5-day treatment regimen, and
$2,397.58 for an 8-day treatment
regimen. The applicant then
standardized and inflated the charges
using a factor of 7.13 percent using the
Medicare Economic Index from the
latest CMS Market Basket Data file.10
The applicant then added the charges
for AVYCAZ and the infusion of
AVYCAZ based on a 5-day treatment
regimen and an 8-day treatment
regimen. Depending on the amount of
charges excluded for the use of specific
drugs and the charges related to the
infusion of these drugs, the applicant
determined a final inflated average caseweighted standardized charge per case
that ranged from $42,469 to $46,842.
8 Antibiotics. Merck Manual. Available at:
https://www.merckmanuals.com/home/infections/
antibiotics.html.
9 The AMR database is a U.S. hospital inpatient
database that provides updated information every 6
months. AMR gathers data from approximately 300
hospitals per year, providing information from
approximately 22,000 patient records. Pharmacists
from these hospitals fill out an inpatient profile
form by verbatim transcription of information from
patient charts, such as patient demographics,
surgery codes, antibiotics used, dosage, start and
end dates for each antibiotic used, and specialty
information. These inpatient profile forms are then
submitted to AMR in paper format. Data from this
sampling of hospitals is projected to the universe
of US hospitals. Available at: https://www.amrdata.com/.
10 Centers for Medicare and Medicaid Services.
Market Basket Data. Available at: https://
www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/
MedicareProgramRatesStats/
MarketBasketData.html.
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Using the FY 2015 IPPS Table 10, the
average case-weighted threshold amount
for all of the MS–DRGs used is $40,303
(all calculations above were performed
using unrounded numbers). Because the
final inflated average case-weighted
standardized charge per case under all
of these scenarios exceeds the average
case-weighted threshold amount, the
applicant maintained that AVYCAZ
meets the cost criterion under this
analysis.
The applicant conducted another
analysis using the 80-percent variable
for 846,897 cases representing patients
diagnosed with a cUTI and/or a cIAI
based on 3 of the ICD–9–CM diagnosis
codes identified across 15 MS–DRGs.
Depending on the amount of the charges
excluded for the cost of the specific
drugs and the charges related to the
infusion of these drugs, the applicant
determined a final inflated average caseweighted standardized charge per case
that ranged from $37,086 to $41,459.
Using the FY 2015 IPPS Table 10, the
average case-weighted threshold amount
across the 15 MS–DRGs used is $36,411
(all calculations above were performed
using unrounded numbers). Because the
final inflated average case-weighted
standardized charge per case under all
of these scenarios exceeds the average
case-weighted threshold amount, the
applicant maintained that AVYCAZ also
meets the cost criterion under this
analysis.
The applicant conducted another
analysis using 100 percent of all of the
cases representing patients who have
been diagnosed with a cIAI (36,181
cases) across 31 MS–DRGs, and
determined an average case-weighted
standardized charge per case of
$51,436.98. The applicant then
excluded the charges for the specific
technology used from the average caseweighted standardized charge per case.
To continue its analysis, the applicant
used two different variables to exclude
the charges for the specific technologies
used; that is, the charges for low-cost
generic drugs and the charges for highcost brand named drugs administered
for a length of 5 and 8 treatment days.
The applicant explained that, at a
minimum, it is recommended that
antibiotics be administered for at least 5
days to prevent the development of
antibiotic-resistant bacteria. The
applicant also noted that, according to
the AMR, the average length of therapy
for patients diagnosed with an UTI and/
or an IAI that was successfully treated
in less than 5 days only represents 0.28
percent of all cases representing these
types of conditions. Therefore, a 5-day
treatment regimen was selected as a
basis to represent the most conservative
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approach. In addition, the AMR’s
database indicated that the length of
therapy for patients diagnosed with an
IAI was 11.2 days and, therefore, the
applicant selected a 8-day regimen as a
basis to represent a more liberal
approach. The applicant then added
charges for AVYCAZ and the infusion of
AVYCAZ based on a 5-day or 8-day
treatment regimen. Depending on the
amount of the charges excluded for the
specific drugs used and the charges
related to the infusion of these drugs,
the applicant determined a final inflated
average case-weighted standardized
charge per case that ranged from
$58,565 to $62,937. Using the FY 2015
IPPS Table 10 thresholds, the average
case-weighted threshold amount across
all of the MS–DRGs used is $51,436 (all
calculations above were performed
using unrounded numbers). Because the
final inflated average case-weighted
standardized charge per case under all
of these scenarios exceeds the average
case-weighted threshold amount, the
applicant maintained that AVYCAZ also
meets the cost criterion under this
analysis.
The applicant conducted another
analysis using the 80-percent variable
for 28,483 cases representing patients
diagnosed with a cIAI based on 5 of the
ICD–9–CM diagnosis codes identified
across 4 MS–DRGs. Depending on the
amount of the charges excluded for the
specific drugs used and the charges
related to the infusion of these drugs,
the applicant determined a final inflated
average case-weighted standardized
charge per case that ranged from
$50,435.54 to $54,809.30. Using the FY
2015 IPPS Table 10 thresholds, the
average case-weighted threshold amount
across all of the MS–DRGs used is
$47,186 (all calculations above were
performed using unrounded numbers).
Because the final inflated average caseweighted standardized charge per case
under all of these scenarios exceeds the
average case-weighted threshold
amount, the applicant maintained that
AVYCAZ also meets the cost criterion
under this analysis.
We are concerned that the applicant
did not use the inflation factor of
10.4427 when calculating the average
case-weighted standardized charge per
case, which is the same inflation factor
used by CMS to update the FY 2015
outlier threshold, and did not offer a
rationale for its alternative inflation
factor. We are inviting public comments
on whether AVYCAZ meets the cost
criterion, specifically with regard to our
concerns.
The applicant maintained that
AVYCAZ represents a substantial
clinical improvement in the available
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treatment options for patients diagnosed
with a cIAI and/or a cUTI, including
cUTIs and cIAIs that are known or
suspected to be caused by extendedspectrum b-lactamase (ESBL)-producing
Gram-negative pathogens, carbapenemresistant Enterobacteriaceae (CRE), and
multidrug-resistant (MDR)
Pseudomonas aeruginosa. According to
the applicant, existing treatment options
for these types of conditions are very
limited and pose toxicity risks. The
applicant stated that antibiotic-resistant
infections are a serious problem for
health care providers and patients.
Among the bacteria resistant to all or
nearly all of the antibiotics available
today, CRE has developed rapidly and
continues to proliferate. The applicant
noted that, as of 2014, 49 States have
reported confirmed CRE infections, an
increase from 42 States that reported
and confirmed CRE infections in
2013.11,12 Almost half of hospital
patients who get bloodstream infections
from CRE bacteria die from the
infection.13 The applicant further noted
that, over the last 20 years, Gramnegative bacteria have evolved in
defense against recently approved
broad-spectrum b-lactam agents (for
example, +-lactam +-lactamase
inhibitors [BL–BLIs] and carbapenems)
by producing a multitude of ‘‘new’’ blactamases—including extendedspectrum b-lactamases (ESBLs) and
carbapenemases that can confer
resistance to these front-line agents.
Because of the technology’s inhibiting
activity against these pathogens, the
applicant maintained that AVYCAZ
may provide a safer and more effective
treatment option for patients diagnosed
with cIAIs and cUTIs caused by these
antibiotic-resistant organisms. The
applicant further noted that there are
serious side effects associated with the
current treatment options and regimens,
such as Polymyxins, Colistin,
Aminoglycosides, Carbapenems, and
Tigecycline,14 including resistance to
nephrotoxicity.
11 Tracking CRE—Carbapenempase producing
CRE in the US. CDC HAI Web site. Available at:
https://www.cdc.gov/hai/organisms/cre/
TrackingCRE.html.
12 Making health care safer—Stop infections from
lethal CRE germs now. CDC Vital Signs 2013.
Available at: https://www.cdc.gov/vitalsigns/pdf/
2013-03-vitalsigns.pdf.
13 Antobiotics. Merck Manual. Available at:
https://www.merckmanuals.com/home/infections/
antibiotics.html.
14 Bader M, Hawboldt J, Brooks A. Management
of complicated urinary tract infections in the era of
antimicrobial resistance. Postgraduate
Medicine.2010; 122(6):7–15.
Rishi H, Dhillon P, Clark C. ESBLs: a clear and
present danger? Critical Care Research and
Practice, 2012; Article ID 625170.
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The applicant provided data from the
REPRISE study, which compared
AVYCAZ and Carbapenem, also used as
a treatment option for patients
diagnosed with cIAIs and cUTIs. This
study was specifically designed to
demonstrate the inhibiting activity of
Avibactam to restore the clinical and
microbiological efficacy of Ceftazidime
verses Ceftazidime-resistant, blactamase-producing Gram-negative
bacteria. According to the applicant, in
the pooled cIAI and cUTI studies,15 the
by-pathogen microbiological response
rate was assessed using the test of cure
(TOC) as a measuring tool. TOC refers
to the reculturing of a site of initial
infection to determine whether the
patient is cured.16 TOC was the same or
numerically higher for AVYCAZ versus
the comparator for almost all pathogens
isolated for the treatment of ceftazidimenonsusceptible (CAZ–NS). We are
concerned that the results of this study
do not show that AVYCAZ has more
favorable clinical or microbiological
responses when compared to existing
technologies. According to
§ 412.87(b)(1) of our regulations, in
order to satisfy the substantial clinical
improvement criterion, the applicant
must demonstrate that the technology
represents an advance that substantially
improves, relative to technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.
The applicant reported that the
INFORM study 17 is one of the ongoing
in vitro studies of AVYCAZ. According
to the results of this study, Avibactam
extends the activity of Ceftazidime and
provides a broad spectrum of activity
compared to currently available
therapies. In addition, AVYCAZ
demonstrated activity against two of the
four areas of need as stated by the CDC,
and potentially demonstrated activity
against a third. The two areas of need
that demonstrated favorable
microbiological response were
carbapenem-resistant Enterobacteriaceae
(CRE) and extended-spectrum blactamase (ESBL). We are concerned
that in vitro studies may not necessarily
correlate with clinical results.
The applicant also provided
conclusions and data from one of the
Phase II clinical trials conducted for
patients diagnosed with cIAIs and
cUTIs, respectively. The applicant
reported that the patients diagnosed
Jacoby GA, Munoz-Price LS. The New bLactamases.N Engl J Med 2005; 352:380–391.
15 Pooled data includes subset of patients from
Phase II trials and interim data from the Phase III
REPRISE trial.
16 https://medicaldictionary.thefreedictionary.com/test+of+cure.
17 Data on File. Actavis 2014.
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with cIAIs were randomized to either
AVYCAZ with Metronidazole versus the
control drug Meropenem. The clinical
cure rates at TOC were 82.4 percent for
the AVYCAZ + Metronidazole group,
and 88.8 percent for the Meropenem
group for patients diagnosed with cIAIs.
For patients diagnosed with cUTIs, the
applicant reported that they were
randomized to either AVYCAZ versus
Imipenem. The clinical cure rates at
TOC were 80.4 percent versus 73.5
percent for the AVYCAZ group versus
the Imipenem group for patients
diagnosed with cUTIs.
The applicant also provided data from
the RECLAIM–1 and RECLAIM–2 trials.
The applicant reported that these trials
evaluated the safety and efficacy of
AVYCAZ versus the control drug used
to treat patients hospitalized for cIAIs.
According to the applicant, AVYCAZ
technology met the objective of
statistical noninferiority when
compared to the control drug. However,
the applicant asserted, in a subgroup of
patients diagnosed with moderate renal
impairment at baseline (MRIB [defined
as an estimated creatinine clearance
(ClCr) of >30 mL/min and ≤50 mL/
min]), AVYCAZ combined with
Metronidazole had lower clinical cure
rates when compared to the control
group. In addition to the clinical
response rate findings, although the
number of deaths was minimal, they
were numerically higher for patients
diagnosed with MRIB who were treated
with AVYCAZ in combination with
Metronidazole when compared to
patients treated with Meropenem. The
applicant acknowledged that this result
was not more favorable and reviewed
the individual cases of failure or
indeterminate (including all deaths) for
the patients diagnosed with MRIB, and
identified no predominant reason for
the treatment difference observed in the
subgroup analysis. However, the
applicant maintained that AVYCAZ
represents a substantial clinical
improvement because of the adverse
effects of other currently available
treatment options such as
nephrotoxicity. We are concerned that
the findings cited by the applicant lack
data regarding the adverse effects of
nephrotoxicity because of treatment
using other currently available
treatment options.
The applicant stated that, in the Phase
II trials, the Medicare-eligible
population represented 9.2 percent of
the total population of patients
diagnosed with cIAIs, and 14.8 percent
of the total population of patients
diagnosed with cUTIs. We are
concerned that a cohort that would
reflect a Medicare population was not
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analyzed or predefined as a subgroup in
the trials to better understand and
quantify the substantial clinical
improvement of AVYCAZ. Furthermore,
we are unsure whether a possibility of
a favorable safety and tolerability profile
for AVYCAZ relative to other currently
available treatment options for patients
diagnosed with cUTIs and cIAIs implies
a substantial clinical improvement.
The applicant maintained that
AVYCAZ represents a substantial
clinical improvement over treatment
options currently available to Medicare
beneficiaries. We do not believe that the
applicant has substantiated this
assertion. With regard to the data
indicating the safety of the technology,
we are concerned that the results for the
trials could be interpreted to suggest
that use of the technology may lead to
increased mortality. We note that the
composition of the treatment and
control groups may make it difficult to
isolate the degree to which AVYCAZ
affects safety and health care outcomes
because the patients in the treatment
group were also treated with another
drug administered in combination with
AVYCAZ. Moreover, we are concerned
that the median age of the participants
enrolled in the studies of AVYCAZ was
between 40 and 50 years. We believe
that it would be indicative to use a
subgroup that actually represents the
eligible Medicare population (that is,
patients who are 65 years of age or
older, blind, disabled, or diagnosed with
end-stage renal disease). The applicant
stated that AVYCAZ had greater efficacy
and safety measures for patients who
have limited or no other available
treatment options. However, we are
concerned that the patient population
enrolled in the applicant’s trials were
not eligible Medicare beneficiaries, nor
was it definitive that these participants
had limited or no other available
treatment options. We are inviting
public comments on whether AVYCAZ
meets the substantial clinical
improvement criterion, specifically with
regard to our stated concerns.
We did not receive any written public
comments in response to the New
Technology Town Hall meeting
regarding the application of AVYCAZ
for new technology add-on payments.
d. DIAMONDBACK 360® Coronary
Orbital Atherectomy System
Cardiovascular Systems, Inc.
submitted an application for new
technology add-on payments for the
DIAMONDBACK 360® Coronary Orbital
Atherectomy System (OAS)
(DIAMONDBACK® Coronary OAS) for
FY 2016. The DIAMONDBACK®
Coronary OAS is a percutaneous orbital
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atherectomy system used to facilitate
stent delivery in patients who have been
diagnosed with coronary artery disease
and severely calcified coronary artery
lesions. The system uses an electrically
driven, diamond-coated crown to
reduce calcified lesions in coronary
blood vessels. The components of the
DIAMONDBACK® Coronary OAS are:
(1) The DIAMONBACK 360® Coronary
Orbital Atherectomy Device (OAD); (2)
the VIPERWIRE Advance Coronary
Guide Wire; (3) the VIPERSLIDE
Lubricant; and (4) the Orbital
Atherectomy System Pump. The
DIAMONBACK 360® OAD is designed
to track exclusively over the
VIPERWIRE, which, in turn, uses the
VIPERSLIDE Lubricant to reduce the
friction between the drive shaft of the
DIAMONBACK 360® OAD and the
VIPERWIRE. The Orbital Atherectomy
System Pump provides the saline
pumping mechanism and power to the
DIAMONBACK 360® OAD. All
DIAMONDBACK® Coronary OAS
devices are single use and provide
sterile application, except for the pump.
With respect to the newness criterion,
the DIAMONDBACK® Coronary OAS
received FDA pre-market approval as a
Class III device on October 21, 2013. As
stated in section II.G.1.a. of the
preamble of this proposed rule, effective
October 1, 2015 (FY 2016), the ICD–10
coding system will be implemented. We
note that the applicant submitted a
request for a unique ICD–10–PCS code
that was presented at the March 18,
2015 ICD–10 Coordination and
Maintenance Committee meeting. If
approved, the code(s) will be effective
on October 1, 2015 (FY 2016). More
information on this request can be
found on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
According to the applicant, the
DIAMONDBACK® Coronary OAS is the
only atherectomy device that uses
centrifugal force and orbital motion and,
therefore, is not represented by the
rotational, directional, or laser
atherectomy device categories (as
exemplified by Boston Scientific’s
Rotablator system, the SilverHawk/
Covidient devices, and the Spectranetics
ELCA Coronary Laser, respectively). In
addition, the applicant asserted that the
DIAMONDBACK® Coronary OAS is the
first and only device approved for use
in the United States as a treatment for
patients who have been diagnosed with
severely calcified coronary artery
lesions to facilitate stent delivery and
optimal deployment. Therefore, the
applicant believed that the
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DIAMONDBACK® Coronary OAS meets
the newness criterion.
We are concerned that, in addition to
patients who have been diagnosed with
severely calcified coronary artery
lesions, the applicant also indicated that
the DIAMONDBACK® Coronary OAS
may be used in the treatment of patients
who do not have severely calcified
coronary artery lesions (for example,
patients for whom the degree of
calcification may not be severe) and that
this technology may be substantially
similar to the rotational, directional, and
laser atherectomy devices that are
already on the U.S. market for the
treatment of such patients. In the FY
2010 IPPS/RY 2010 LTCH PPS final rule
(74 FR 43813 through 43814), we
established criteria for evaluating
whether a new technology is
substantially similar to an existing
technology, specifically: (1) Whether a
product uses the same or a similar
mechanism of action to achieve a
therapeutic outcome; (2) whether a
product is assigned to the same or a
different MS–DRG; and (3) whether the
new use of the technology involves the
treatment of the same or similar type of
disease and the same or similar patient
population. If a technology meets all
three of these criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With respect to the first criterion, the
applicant maintained that the
technology uses a differential sanding
mechanism of action to remove plaque
while potentially minimizing damage to
the medial layer of the vessel.
According to the applicant, this
mechanism of action is the only one
among atherectomy devices to use
centrifugal force and orbital motion and,
therefore, is not represented by the
rotational, directional, or laser
atherectomy device categories. We are
concerned that the applicant did not
include with their application data to
show the effectiveness of the orbital
mechanism of the DIAMONDBACK®
Coronary OAS compared to the
effectiveness of the rotational,
directional, and laser mechanisms of
similar devices used in treating patients
with calcified coronary artery lesions.
Therefore, we cannot determine if the
device’s mechanism of action is unique
among atherectomy devices as the
applicant claimed.
With respect to the second criterion,
the applicant determined that coronary
atherectomy cases for which the
DIAMONDBACK® Coronary OAS
technology would be appropriate are
assigned to MS–DRG 246 (Percutaneous
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Cardiovascular Procedure with DrugEluting Stent with MCC or 4+ Vessels/
Stents); MS–DRG 247 (Percutaneous
Cardiovascular Procedure with DrugEluting Stent without MCC); MS–DRG
248 (Percutaneous Cardiovascular
Procedure with Non-Drug-Eluting Stent
with MCC or 4+ Vessels/Stents); MS–
DRG 249 (Percutaneous Cardiovascular
Procedure with Non-Drug-Eluting Stent
without MCC); MS–DRG 250
(Percutaneous Cardiovascular Procedure
without Coronary Artery Stent with
MCC), and MS–DRG 251 (Percutaneous
Cardiovascular Procedure without
Coronary Artery Stent without MCC).
We are concerned that potential cases
involving the DIAMONDBACK®
Coronary OAS would be assigned to the
same MS–DRGs as other cases that use
atherectomy devices currently available
on the U.S. market.
With respect to the third criterion, the
applicant maintained that the
DIAMONDBACK® Coronary OAS is the
first and only device approved for use
in the United States as a treatment for
severely calcified coronary lesions.
According to the applicant, advances in
current stent technology have allowed
most patients with coronary lesions to
be treated effectively with relatively
favorable long-term outcomes. However,
there remain subsets of the patient
population that are still challenging to
treat, including patients with severe
coronary calcification. According to the
applicant, the DIAMONDBACK®
Coronary OAS is the only atherectomy
device currently available to treat this
patient population because it is the first
and only device approved for use in the
United States for severely calcified
coronary lesions. However, we are
concerned that other devices currently
available on the U.S. market may not
necessarily be contraindicated for use in
treating patients with severe coronary
calcification. Specifically, we are not
sure if patients with less than severe
coronary calcification could be
appropriately treated using the
DIAMONDBACK® Coronary OAS or
other atherectomy devices currently
available on the U.S. market in order to
determine if the DIAMONDBACK®
Coronary OAS treats a different patient
population as the applicant claimed.
We are inviting public comments on
if, and how, the DIAMONDBACK®
Coronary OAS meets the newness
criterion. In our subsequent discussion
of the cost and substantial clinical
improvement criteria, we limit our
analysis of the new technology device to
a patient population who has severely
calcified coronary lesions for which the
other devices are contraindicated for
use.
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With respect to the cost criterion, the
applicant determined that cases
representing patients who have been
treated with transluminal coronary
atherectomy for which the
DIAMONDBACK® Coronary OAS
technology is appropriate map to MS–
DRGs 246 through 251 as noted earlier
in this section. The applicant searched
the claims data in the FY 2013 MedPAR
file for cases assigned to these six MS–
DRGs (which contained claims for
inpatient hospital discharges from
October 1, 2012 to September 30, 2013)
and identified 5,443 claims for cases
reporting ICD–9–CM procedure code
17.55. The applicant indicated that it
further examined the claims data for the
cases that also reported ICD–9–CM
diagnosis code 414.4, and identified 250
claims for cases with a diagnosis of
calcified coronary lesion. The applicant
stated that it applied the standard trims
used by CMS when selecting cases for
IPPS rate calibration. Therefore, it
included cases from IPPS hospitals,
including hospitals located in
Maryland, and excluded cases paid by
Medicare Advantage plans, statistical
outlier cases, and cases from hospitals
that did not submit charges in a
sufficiently broad range of revenue
centers.
The applicant reported that it
conducted 16 sensitivity analyses based
on four areas of uncertainty: Whether to
include all coronary atherectomy cases
in the analysis or only those cases that
reported calcified coronary artery
lesions; whether to consider a lower
value or higher value as the acquisition
cost of a typical atherectomy catheter;
whether to use the full cost of the
DIAMONDBACK® Coronary OAS
catheter and materials or only the cost
of the catheter alone; and whether to
include or exclude a factor to inflate
costs to FY 2015 costs. Based on the
result of the sensitivity analyses with all
16 combinations of the values that the
applicant performed, the applicant
reported that it determined that the
average case-weighted standardized
charge per case for the
DIAMONDBACK® Coronary OAS would
exceed the average case-weighted
threshold amounts for MS–DRGs 246
through 251 in Table 10 of the FY 2015
IPPS/LTCH PPS final rule. According to
the applicant, the average case-weighted
standardized charge per case using the
DIAMONDBACK® Coronary OAS
device exceeds the average caseweighted threshold amounts for MS–
DRGs 246 through 251 in Table 10 by
between approximately $6,000 to
$15,000, depending on the results
determined by using the combination of
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values of the four areas of uncertainty.
As described below, the applicant
believed that using the scenario that
produced the lowest difference between
the average case-weighted standardized
charge per case determined by the
applicant’s analyses and the average
case-weighted threshold amounts for
MS–DRGs 246 through 251 from Table
10 in the FY 2015 IPPS/LTCH PPS final
rule still exceeded the Table 10
threshold amounts by $5,803.
Using the scenario that produced the
lowest difference between the average
case-weighted standardized charge per
case determined by the applicant and
the average case-weighted threshold
amount in the FY 2015 IPPS/LTCH PPS
final rule Table 10, the applicant
included all cases reporting coronary
atherectomy (specifically, the 5,443
cases reported with ICD–9–CM
procedure code 17.55) in this analysis.
The applicant removed the costs of the
other specific technologies used during
these procedures; that is, the applicant
removed the higher of the two standard
catheter costs, and added the full cost of
the DIAMONDBACK® Coronary OAS
catheter alone. To estimate the cost for
the new technology, the applicant
divided the projected cost per patient by
the national average CCR for supplies
(0.292) included in the FY 2015 IPPS/
LTCH PPS final rule. This resulted in an
average case-weighted average
standardized charge per case of $86,080.
The applicant stated that it did not
apply an inflation factor to convert the
FY 2013 costs to FY 2015 costs for this
analysis. However, in other analyses,
the applicant used the 2-year inflation
factor of 10.44 percent taken from the
FY 2015 IPPS/LTCH PPS final rule (79
FR 50379), which was the final inflation
factor used in the CMS outlier threshold
calculation for the applicable fiscal year.
The applicant then determined that its
average case-weighted standardized
charge per case exceeded the average
case-weighted threshold amounts for
MS–DRGs 246 through 251 in Table 10
of the FY 2015 IPPS/LTCH PPS final
rule by $5,803. The applicant
maintained that all of the results of the
analyses using this methodology that
were included in its application
likewise exceeded the Table 10
threshold amounts for these MS–DRGs
and, therefore, demonstrated that the
DIAMONDBACK® Coronary OAS meets
the cost criterion.
Using the scenario that produced the
lowest difference between its average
case-weighted standardized charge per
case and the average case-weighted
threshold amounts for MS–DRGs 246
through 251 from the FY 2015 Table 10
for the analysis of the subgroup of cases
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representing patients who have severely
calcified coronary artery lesions, the
applicant reported that it included all of
the cases that report coronary
atherectomy that also reported diagnosis
of calcified coronary lesions (250 cases
reporting ICD–9–CM procedure code
414.4). As in the previous scenario, the
applicant removed costs of the other
specific technologies used during these
other procedures; that is, the applicant
removed the higher of the two standard
catheter costs, and added the full cost of
the DIAMONDBACK® Coronary OAS
catheter alone. To estimate the costs for
the new technology, the applicant
divided the projected cost per patient by
the national average CCR for supplies
(0.292) in the FY 2015 IPPS/LTCH PPS
final rule. This resulted in an average
case-weighted standardized charge per
case of $86,779. The applicant did not
apply an inflation factor to convert the
FY 2013 costs to FY 2015 costs for this
analysis. The applicant then determined
that the average case-weighted
standardized charge per case exceeded
the FY 2015 Table 10 threshold amount
of $80,807 by $5,972. The applicant
maintained that all of the results of the
analyses using this methodology that
were included in its application
likewise exceeded the Table 10
threshold amounts for these MS–DRGs
and, therefore, demonstrated that the
DIAMONDBACK® Coronary OAS meets
the cost criterion.
We question some of the assumptions
underlying the four areas of uncertainty
that were the basis for the applicant’s
sensitivity analyses. We would like to
know the basis of the higher value that
the applicant considered to be a
possible acquisition cost of a typical
atherectomy catheter. We also are
concerned that the applicant did not
provide a basis for determining the two
values it used to remove the costs
associated with the other specific
technologies that may have been used
during the cases included in the
analysis. We are inviting public
comments on if, and how, the
DIAMONDBACK® Coronary OAS meets
the cost criterion.
The applicant maintained that the
DIAMONDBACK® Coronary OAS offers
a treatment option for a patient
population that has been diagnosed
with severely calcified coronary arteries
that are ineligible for currently available
treatments and results in improved
clinical outcomes for patients who have
been diagnosed with complex coronary
artery disease related to severely
calcified coronary arteries. The
applicant also stated that the
DIAMONDBACK® Coronary OAS
device significantly improves clinical
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outcomes for this patient population
when compared to currently available
treatment options, including reduced
mortality, a reduced rate of devicerelated complications, a decreased rate
of subsequent diagnostic or therapeutic
interventions (for example, due to
reduced rate of recurrence of the disease
process), a decreased number of future
hospitalizations or physician visits,
more rapid beneficial resolution of the
disease process treatment because of the
use of the device, decreased pain,
bleeding, or other quantifiable
symptoms, and reduced recovery time.
The applicant included data from its
ORBIT II study to demonstrate that the
technology represents substantial
clinical improvement over currently
available treatment options, including
improvement in mortality rates, major
adverse cardiac event (MACE) rates,
revascularization rates, and cost savings.
According to the applicant, its ORBIT II
study was a pivotal clinical study to
evaluate the safety and effectiveness of
the DIAMONDBACK® Coronary OAS in
treating a subset of patients who have
severely calcified coronary artery
lesions. The applicant explained that
the ORBIT II study was a prospective,
multicenter, non-blinded clinical trial
that enrolled 443 consecutive patients
who have been diagnosed with severely
calcified coronary lesions at 49 U.S.
sites from May 25, 2010 to November
26, 2012, in which the
DIAMONDBACK® Coronary OAS was
used to prepare patients who had
severely calcified coronary lesions for
stent placement. According to the
applicant, the DIAMONDBACK®
Coronary OAS produced clinical
outcomes that exceeded its ORBIT II
study’s two primary safety and efficacy
endpoints within a patient population.
The primary safety endpoint was 89.6
percent freedom from 30-day MACE,
compared with the performance goal of
83 percent. The primary efficacy
endpoint (residual stenosis <50 percent
post-stent without in-hospital MACE)
was 88.9 percent, compared with the
performance goal of 82 percent. The
applicant stated that, during the trial,
stent delivery after use of the
DIAMONDBACK® Coronary OAS
occurred successfully in 97.7 percent of
cases with <50 percent residual stenosis
in 98.6 percent of the patients in the
study. The applicant further stated that
low rates of in-hospital Q-wave MI,
cardiac death, and target vessel
revascularization also were reported.
The applicant believed that the results
of its ORBIT II study met both the
primary safety and efficacy endpoints
by significant margins and not only
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helped to facilitate stent delivery, but
also improved both acute care and 30day clinical outcomes compared to
historical controls.
The applicant also compared the
results of its ORBIT II study with
historical study data that measured the
performance of other coronary
atherectomy devices used in the
treatment of patients who have
moderate to severely calcified coronary
lesions. According to the applicant, the
death and revascularization rates
reported in the ORBIT II study were
much lower than those rates reported in
the literature for patients who had
severely calcified coronary lesions. For
example, inpatient cardiac death rates
were reported on one reported study in
the literature (Mosseri, et al.) as 1.6
percent and in another reported study
(Abdel-Wahab, et al.) as 1.7 percent,
while another study report (Clavijo, et
al.) reported death at 30 days as 2.6
percent and 1.5 percent for RA + DES
and DES, respectively. 18 19 20 The
applicant maintained that, compared to
these historical study data, the data
results of the ORBIT II study
demonstrated much lower cardiac death
rates of 0.2 percent in-hospital and 0.2
percent at 30 days. The applicant
further reported that the results of its
ORBIT II study showed lower mortality
rates at 9 months and 1 year (3 percent
and 4.4 percent, respectively) compared
to previously reported rates (5.0 percent
and 5.85 percent at 9 months and 6.3
percent at 1 year). The study report by
Mosseri, et al. also reported a 1.6
percent in-hospital target lesion
revascularization rate (TLR) in a patient
population with more superficial
calcification,21 whereas the study report
by Clavijo, et al. reported a 1.3 percent
30-day TLR rate for the RA + DES
group.22 In contrast, the applicant
18 Mosseri M, Satler LF, Pichard AD, Waksman R.
Impact of vessel calcification on outcomes after
coronary stenting. Cardiovasc Revascularization
Med Mol Interv. 2005;6(4):147–153.
19 Abdel-Wahab M, Richardt G, Joachim Buttner
H, et al. High-speed rotational atherectomy before
paclitaxel-eluting stent implantation in complex
calcified coronary lesions: the randomized
ROTAXUS (Rotational Atherectomy Prior to Taxus
Stent Treatment for Complex Native Coronary
Artery Disease) trial. JACC Cardiovasc Interv.
2013;6(1):10–19.
20 Clavijo LC, Steinberg DH, Torguson R, et al.
Sirolimus-eluting stents and calcified coronary
lesions: clinical outcomes of patients treated with
and without rotational atherectomy. Catheter
Cardiovasc Interv Off J Soc Card Angiogr Interv.
2006;68(6):873–878.
21 Mosseri M, Satler LF, Pichard AD, Waksman R.
Impact of vessel calcification on outcomes after
coronary stenting. Cardiovasc Revascularization
Med Mol Interv. 2005;6(4):147–153.
22 Clavijo LC, Steinberg DH, Torguson R, et al.
Sirolimus-eluting stents and calcified coronary
lesions: clinical outcomes of patients treated with
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reported that the results of the ORBIT II
study showed a lower TLR rate of 0.7
percent (both in-hospital and 30-day),
even though more patients who had
severely calcified coronary lesions were
included in the study, and the patients
were older and had more comorbidities.
The applicant stated that, at 1-year, the
results of the ORBIT II study showed a
higher freedom from TVR/TLR rate (94.1
percent) compared to previously
reported rates (81.7 percent to 91.3
percent), even though patients who had
more severely calcified coronary lesions
were included in the ORBIT II study.
According to the applicant, the MACE
rate of 16.4 percent indicated in the
results of the ORBIT II study was lower
than the rate of the ROTAXUS (24.4
percent) and ACUITY/HORIZONS (19.9
percent) trials despite the use of a less
stringent standard of severe calcification
in the latter studies.23 24 Further, the
applicant reported that patients in the
ORBIT II study experienced a lower rate
of device-related complications (such as
dissection, abrupt closure, and
perforation) compared to rates in the
historical studies. Overall, the applicant
asserted that a comparison of data from
the ORBIT II study and the data from
historical studies demonstrates that
patients in the ORBIT II study had more
severe calcium coronary lesions and
potentially were more difficult to treat,
although they experienced better
outcomes.
We are concerned that the ORBIT II
study conducted by the applicant lacked
a control arm. The applicant asserted
that although other FDA-approved
coronary atherectomy products are
available, none of them are indicated for
the treatment of patients who have
severely calcified coronary arteries and,
therefore, could not be used as a control.
The applicant believed that it accounted
for this study limitation by comparing
the results of the ORBIT II study to
historical control subjects documented
in published reports. However, we
and without rotational atherectomy. Catheter
Cardiovasc Interv Off J Soc Card Angiogr Interv.
2006;68(6):873–878.
23 Genereux P, Madhavan MV, Mintz GS, et al.
Ischemic outcomes after coronary intervention of
calcified vessels in acute coronary syndromes.
Pooled analysis from the HORIZONS–AMI
(Harmonizing Outcomes With Revascularization
and Stents in Acute Myocardial Infarction) and
ACUITY (Acute Catheterization and Urgent
Intervention Triage Strategy) TRIALS. J Am Coll
Cardiol. 2014;63(18):1845–1854.
24 Abdel-Wahab M, Richardt G, Joachim Buttner
H, et al. High-speed rotational atherectomy before
paclitaxel-eluting stent implantation in complex
calcified coronary lesions: the randomized
ROTAXUS (Rotational Atherectomy Prior to Taxus
Stent Treatment for Complex Native Coronary
Artery Disease) trial. JACC Cardiovasc Interv.
2013;6(1):10–19.
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continue to be concerned that
meaningful conclusions cannot be
drawn from a study that did not include
a comparator group. Moreover, we
question the reliability of comparing
data from the ORBIT II study to
historical study data because different
definitions of severe calcification used
in each study can make absolute
comparisons difficult and/or invalid.
We are inviting public comments on if,
and how, DIAMONDBACK® Coronary
OAS meets the substantial clinical
improvement criterion.
e. CRESEMBA® (Isavuconazonium)
Astellas Pharma US, Inc. (Astellas)
submitted an application for new
technology add-on payments for
CRESEMBA® (isavuconazonium) for FY
2016. CRESEMBA® is an intravenous
and oral broad-spectrum antifungal used
for the treatment of adults who have
severe invasive and life-threatening
fungal infections, including invasive
aspergillosis and mucormycosis
(zygomycosis).
CRESEMBA® received FDA approval
on March 6, 2015 and anticipates that
the market availability on the U.S.
market will start by the second week of
April 2015. The FDA indication for the
use of this product is for the treatment
of adults who have been diagnosed with
invasive aspergillosis and
mucormycosis. Isavuconazonium has
two formulations: An intravenous (IV)
solution and an oral capsule. The IV
formulation of isavuconazonium is
administered at 200 mg of
isavuconazole. The oral formulation of
isavuconazonium is administered at 100
mg of isavuconazole. Dosing is not
weight-based. According to the
applicant, treatment of patients who
have been diagnosed with these types of
infection starts with up to 3 days of IV
therapy in the inpatient hospital setting
followed by daily oral therapy
administered for the remainder of the
inpatient stay and also the duration of
treatment period, which is 13.4 days.
As stated in section II.G.1.a. of the
preamble of this proposed rule, effective
October 1, 2015 (FY 2016), the ICD–10
coding system will be implemented. We
note that the applicant submitted a
request for unique ICD–10–PCS codes
that was presented at the March 18,
2015 ICD–10 Coordination and
Maintenance Committee meeting. If
approved, the codes will be effective on
October 1, 2015 (FY 2016). More
information on this request can be
found on the CMS Web site at: https://
www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
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If the technology were to be approved
for a new technology add-on payment,
we believe its newness period would
begin on March 6, 2015, the date of FDA
approval. At this time, the applicant has
not submitted any specific information
to establish that the technology was not
available on the U.S. market as of the
FDA approval date or to describe the
reasons for a delay of availability until
the second week of April 2015. The
applicant maintained that CRESEMBA®
meets the newness criterion.
CRESEMBA® is part of the category of
drugs known as azole antifungal drugs
that inhibit the enzyme lanosterol 14 ademethylase. Inhibiting this enzyme
disrupts the process of converting
lanosterol to ergosterol and, therefore,
depletes the level of ergosterol in the
fungal membrane and inhibits fungal
growth. Azole antifungal drugs are used
to treat patients with fungal infections
such as aspergillosis, and other azole
antifungal drugs also used for the
treatment of these patients include
voriconazole, posaconazole, and
itroconazole. The CDC Web site at
https://www.cdc.gov/fungal/diseases/
aspergillosis/treatment.html states that
voriconazole is used for the treatment of
patients with invasive aspergillosis, but
Amphotericin B (Amp B) as well as
other antifungal drugs can be used if
patients cannot take voriconazole or the
infection is not responsive to
voriconazole. Amphotericin B is the
first-line of therapy and the only
FDA-approved treatment of patients
diagnosed with mucormycosis.
Amphotericin B binds with ergosterol, a
component of fungal cell membranes,
and forms a transmembrane channel
that leads to membrane leakage, which
is the primary effect leading to fungal
cell death. The third class of antifungal
drugs is echinocandins; examples in
this group are caspofungin, micafungin,
and anidulafungin. Echinocandins
noncompetitively inhibit beta-1, 3-Dglucan synthase enzyme complex in
susceptible fungi to disturb fungal cell
glucan synthesis. Beta-glucan
destruction prevents resistance against
osmotic forces, which leads to cell lysis
(https://www.cdc.gov).
According to the applicant,
echinocandins are effective against
aspergillosis. Voriconazole is the
recommended treatment for patients
diagnosed with invasive aspergillosis.
However, amphotericin B and other
antifungal drugs may also be used if
voriconazole cannot be administered
because a patient is suffering from
porphyria (a rare inherited blood
disorder) or has had an allergic reaction
to the drug or the infection is not
responding to treatment using
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voriconazole. In addition, according to
the applicant, the efficacy of azole
antifungal drugs such as posaconazole,
in treating mucurmycosis is uncertain
but has been described in certain
situations.
The applicant stated that it is
sometimes challenging to clinically
distinguish the type of antifungal
infection a patient may be experiencing.
Therefore, the typical treatment of
patients exhibiting symptoms of
infection includes both amphotericin B
and voriconazole. According to the
applicant, for the Medicare population,
both drugs are usually administered in
combination because it is difficult and
time-consuming to delineate the specific
type of fungal infections. The applicant
noted that these patients are often
severely ill and immediate treatment of
these symptoms is essential to the
effective management of their condition.
We are concerned that CRESEMBA®
may be substantially similar to other
currently approved antifungal drugs. We
refer readers to the FY 2010 IPPS/RY
2010 LTCH PPS final rule (74 FR 43813
through 43814) for a discussion of our
established criteria for evaluating
whether a new technology is substantial
similar to an existing technology. If a
technology meets all three of these
criteria, it would be considered
substantially similar to an existing
technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
In evaluating this technology for
substantial similarity, we believe that
CRESEMBA® has a similar mechanism
of action as the other groups of
antifungal drugs available for the
treatment of patients with serious fungal
infections, such as invasive aspergillosis
and mucormycosis. As previously
noted, voraconazole and itroconazole
also are commonly used azole
antifungals used to treat patients
diagnosed with aspergillosis, and
amphotericin B is a polyene antifungal
commonly used to treat patients
diagnosed with mucormycosis. The
applicant maintained that the
availability of the drug in an oral
formulation constitutes a different
mechanism of action. We disagree with
the applicant’s assertion because we
believe a different method of
administration does not necessarily
equate to a different mechanism of
action. Although the applicant
maintained that this technology is not
substantially similar because it is
administered orally, the applicant did
not describe why it believed a different
method of administration constitutes a
different mechanism of action. Because
CRESEMBA® is part of the category of
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drugs currently available known as
azole antifungal drugs that inhibit the
enzyme lanosterol 14 a-demethylase, it
appears that the mechanism of action is
not different, but that merely the
method of administration differs.
With respect to the second criterion
for determining substantial similarity,
we believe that the use of CRESEMBA®
is inclusive of the current treatment
options available to Medicare
beneficiaries and is also currently
described (although not specifically) by
established procedure codes that
identify similar technologies,
specifically other antifungal drugs that
also are used in the treatment of patients
diagnosed with similar fungal
infections. The use of antifungal drugs
is considered a nonoperating room
procedure which does not impact the
MS–DRG assignment of a patient case.
Therefore, the use of CRESEMBA®
would not impact the MS–DRG
assignment of a particular case.
Furthermore, the technology is
indicated for use in the treatment of the
same or similar type of disease and the
same or similar patient population.
According to the applicant,
CRESEMBA® is used in conjugation
with other treatments, and this is
reflected in its analysis for the new
technology cost criterion. We are
concerned that this technology is
administered with the other currently
available treatments, and therefore
cannot be considered an alternative
treatment option. Therefore, we believe
that CRESEMBA® may be considered
substantially similar to other available
treatments and cannot be considered
‘‘new’’ for purposes of new technology
add-on payments. We are inviting
public comments on if, and how,
CRESEMBA® meets the newness
criterion and our concerns regarding
how it is substantially similar to other
treatments for serious fungal infections.
To demonstrate that the technology
meets the cost criterion, the applicant
performed two analyses. The applicant
searched claims in the FY 2013
MedPAR file (across all MS–DRGs) for
any case reporting a principal or
secondary diagnosis of aspergillosis
(ICD–9–CM diagnosis code 117.3),
zygomycosis [phycomycosis or
mucormycosis] (ICD–9–CM diagnosis
code 117.7), or pneumonia in
aspergillosis (ICD–9–CM diagnosis code
484.6). The applicant excluded any case
that was treated at a hospital that is not
paid under the IPPS, as well as any case
where Medicare fee-for-service was not
the primary payer. The applicant
calculated the standardized charge for
each eligible case and then inflated the
standardized charge by 10.4427 percent
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using the same inflation factor used by
CMS to update the FY 2015 outlier
threshold (79 FR 50379). The applicant
assumed that the average length of stay
for all eligible cases was 13.4 days based
on its analysis. To determine the
charges for the drug, the applicant
assumed 13.4 days of therapy.
According to the applicant, dosages of
isavuconazole for a patient vary based
on the day of therapy, but do not vary
based on the patient’s weight. For the
first and second day of therapy, the
patient would be administered a loading
dose of 200 milligrams (mg) every 8
hours. For each subsequent day of
therapy, the patient would be
administered a maintenance dose of 200
mg per day.
For the first analysis, which was
based on 100 percent of all MS–DRGs,
the applicant identified a total of 5,984
cases with at least one of the three ICD–
9–CM codes (aspergillosis (ICD–9–CM
diagnosis code 117.3), zygomycosis
[phycomycosis or mucormycosis] (ICD–
9–CM diagnosis code 117.7), or
pneumonia in aspergillosis (ICD–9–CM
diagnosis code 484.6)) across a total of
333 MS–DRGs. The applicant’s rationale
for using all the MS–DRGs was that it
believed any patient diagnosed with
either invasive aspergillosis or invasive
mucormycosis (zygomycosis) could be
eligible for treatment using
isavuconazonium, regardless of the
MS-DRG assignment. The applicant
identified the average case-weighted
threshold amounts for these 333 MS–
DRGs as $72,186 using Table 10 from
the FY 2015 IPPS/LTCH PPS final rule.
The applicant did not remove charges
for the other specific technologies from
the average case-weighted standardized
charge per case. The applicant’s
rationale for not removing these charges
was that the patients would be
administrated isavuconazonium in
combination with the other currently
approved antifungal drugs as an
effective treatment plan. The applicant
computed a final inflated average caseweighted standardized charge per case
of $151,450. Because this average caseweighted standardized charge per case
exceeded the average case-weighted
threshold amount from the FY 2015
Table 10, the applicant maintained that
CRESEMBA® meets the cost criterion
using this first analysis.
For its second analysis, the applicant
analyzed 39 MS–DRGs that accounted
for the top 75 cases of patients eligible
for treatment using isavuconazonium;
this was a subset of 4,510 cases. Using
a methodology similar to the one used
in its first analysis, the applicant
computed the final inflated average
case-weighted standardized charge per
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case of $159,622. The applicant
identified an average case-weighted
threshold amount for the 39 MS–DRGs
of $74,366 using Table 10 from the
FY2015 IPPS/LTCH PPS final rule.
Because the final inflated average caseweighted standardized charge per case
exceeded the average case-weighted
threshold amount in the FY 2015 Table
10, the applicant maintained that
CRESEMBA® meets the cost criterion
using this second analysis.
We are concerned that the applicant
did not remove any charges for the other
antifungal drugs used during treatments
(that is, the other component of the
combination) because the applicant
maintained that it would most likely be
necessary for patients who are treated
using CRESEMBA® to also continue
treatment using the other antifungal
drugs or medications in order to achieve
successful treatment due to the severity
of their symptoms. We believe that the
applicant should have removed the
charges for the other antifungal drugs
used for treatments. We also note that
the applicant did not provide
information to substantiate its assertion
that the charges for these cases would
not be reduced because of the severity
of illness among the patients. The
applicant inferred that patients treated
using CRESEMBA® would be dependent
upon the simultaneous and combined
use of the other existing therapies to
achieve successful treatment. Therefore,
we are concerned about the possibility
of drug toxicity, poly pharmacy, and
drug-to-drug interactions, especially
among the Medicare population.
We are seeking public comment on
whether CRESEMBA® meets the cost
criterion, specifically with regard to our
concerns regarding the applicant’s
analyses and methodology.
With regard to substantial clinical
improvement, the applicant believed
that CRESEMBA® represents a
substantial clinical improvement over
existing therapies for patients diagnosed
with invasive aspergillus and
mucormycosis based on its potentially
improved efficacy profile, potentially
improved safety profile, more favorable
pharmacokinetic profile, and improved
method of administration. The applicant
discussed the unmet medical need for
alternative treatment options for
patients diagnosed with invasive
aspergillosis and mucormycosis.
Current treatments have limitations
related to safety, side effects, and
efficacy.25 26 The applicant provided
25 Lin SJ, Schranz J, Teutsch SM.: Aspergillosis
case-fatality rate: systematic review of the literature.
ClinInfect Dis. 2001;32:358-66.
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information regarding its SECURE
study, where the primary endpoint of
all-cause mortality through day 42
showed that CRESEMBA® demonstrated
noninferiority to voriconazole. The
primary endpoint of all-cause mortality
through day 42 in the intent-to-treat
population (ITT, N = 516) was 18.6
percent in the isavuconazonium
treatment group and 20.2 percent in the
voriconazole group. However, according
to the applicant, the overall safety
profile for CRESEMBA® demonstrated
similar rates of mortality and nonfatal
adverse events as the comparator,
voriconazole. The applicant also shared
information from other clinical trials.
One of these clinical trials that studied
the treatment of patients diagnosed with
invasive aspergillosis showed treatmentemergent adverse reactions occurred in
96 percent and 99 percent of patients
receiving the CRESEMBA® and
voriconazole, respectively. We are
concerned that the adverse reactions
associated with the use of CRESEMBA®
and voriconazole appear to be similar.
We also are concerned that the
applicant did not conduct the clinical
trials evaluating head-to-head
comparisons to alternative therapies
such as amphotericin B. Currently,
amphotericin B is the only
FDA-approved drug for the treatment of
mucormycosis, which also can be used
to treat aspergillosis. The applicant’s
description of the technology was based
on peer reviewed literature, which may
be considered historical data.
With regard to improved efficacy, the
applicant made several assertions. The
applicant maintained that the use of
CRESEMBA® can potentially decrease
the rate of subsequent diagnostic or
therapeutic interventions. According to
the applicant, the technology lacks the
adverse side effects of nephrotoxicity
associated with amphotericin B.27
However, we are concerned that the
results of the study reported by the
applicant did not reflect this.
Specifically, the applicant believed
that CRESEMBA® has positive activity
against a broad range of fungi, including
those resistant to other agents, thereby
potentially decreasing subsequent
therapeutic interventions.28 However,
26 Greenberg RN, Scott LJ, Vaughn HH, Ribes JA.:
Zygomycosis (mucormycosis): emerging clinical
importance and new treatments. Curr Opin Infect
Dis. 2004;17:517-25.
27 Walsh TJ, Anaissie EJ, Denning DW, Herbrecht
R, Kontoyiannis DP, Marr KA, et al.: Treatment of
aspergillosis: clinical practice guidelines of the
Infectious Diseases Society of America. Clin Infect
Dis. 2008;46:327-60.
28 Gonzalez GM.: Med Mycol. 2009 Feb;47(1):71–
´
6. doi:10.1080/13693780802562969. Epub 2008 Dec
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the applicant stated that the referenced
literature indicates that further in-vivo
studies are required in order to confirm
the efficacy for treatment of severe
infections caused by these fungi in
immunocompromised patients.
According to the applicant,
CRESEMBA® is used to treat
immunocomprised patients who are
severely ill. The applicant also stated
that CRESEMBA® can be used to treat
patients diagnosed with invasive fungal
infections before the pathogen has been
identified, thereby potentially
decreasing subsequent diagnostic and
therapeutic interventions.29 The
applicant maintained that the use of
CRESEMBA® decreases the number of
future hospitalizations or physician
visits. We are concerned that the
applicant did not provide data to
support this determination. One of the
applicant’s studies, SECURE, which was
a global, Phase 3, multicenter,
randomized, double-blind, parallel
group, noninferiority trial that evaluated
isavuconazole versus voriconazole for
the primary treatment of patients with
invasive fungal disease (IFDs) caused by
aspergillus spp. and other filamentous
fungi was discussed by the applicant in
its application. The results of the study
were presented in a paper stating that
the length of stay for patients
hospitalized with renal impairment was
statistically significantly shorter in the
treatment of patients in the
isavuconazole arm (9 days) compared
with patients treated with voriconazole
in the control arm. According to the
applicant, patients treated with
isavuconazonale showed shorter
hospital length of stay compared to
those treated with voriconazole in the
overall study population. Subgroup
analyses of patients who were aged 65
years and older and patients with a BMI
equal to or greater than 30 kg/m2 also
had shorter, but not statistically
significant, differences in length of stay
when treated with isavuconazonale
compared to voriconazole. The paper on
the study revealed concerns about the
small sample size in the subgroup (n =
516) and that the differences were not
statistically significant.30
With regard to improved safety and a
more favorable pharmacokinetic profile,
the applicant made several assertions.
18. PMID: 19101837 [PubMed—indexed for
MEDLINE]
29 Kontoyiannis DP, Lewis RE.: How I treat
mucormycosis. Blood. 2011;118:1216-24.
30 Khandelwal N, Franks B, Shi F, Spalding J,
Azie N. Health Economic Outcome Analysis of
Patients Randomized in the SECURE Phase 3 Trial
Comparing Isavuconazole to Voriconazole for
Primary Treatment of Invasive fungal Disease
Caused by Aspsergillus Species or Other
Filamentous Fungi.
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The applicant asserted that
CRESEMBA® has the potential for
simpler and more predictable dosing
based on improved pharmacokinetics
compared with other azole antifungal
drugs, but the applicant did not provide
data to substantiate this assertion. In
addition, the applicant asserted that
CRESEMBA® has a lower drug-drug
interaction potential than voriconazole
or itraconazole, but did not provide data
to substantiate this assertion.
Furthermore, the applicant maintained
that CRESEMBA® can be safely used in
treating patients with renal impairment,
whereas currently available treatments
can harm the kidneys.31 In the paper
accompanying the application, the
applicant discussed aspergillosis and
the various treatment options available
and the advantages of voriconazole over
deoxycholate amphotericin B (D–AMB)
as primary treatment for patients with
invasive aspergillosis. We are concerned
that these results were not
communicated in the resulting data
provided by the applicant that were
obtained from the trials. We also are
concerned that the applicant did not
provide a rationale for its assertion that
the use of CRESEMBA® represents a
substantial clinical improvement for
Medicare beneficiaries because of
‘‘simpler and more predictable dosing’’
nor did the applicant provide additional
information and data regarding drug-todrug interactions and nephrotoxicity.
In addition, the applicant maintained
that the technology has an improved
method of administration compared to
current treatment alternatives.
Specifically, the applicant asserted that
the availability of this technology as an
oral formulation is an improvement
compared to other existing treatments,
which are solely administered
intravenously. We are concerned about
the applicant’s assertion because other
currently approved and available
antifungal drugs, such as voriconazole
(tablets, oral suspension, or intravenous
administration), itraconazole (capsules,
oral solution, or parenteral solution),
and posaconazole (oral suspension or
parenteral solution), also can be
administered orally as well as parenteral
for patients diagnosed with these types
of fungal infections. In addition, we are
aware that intravenous administration
of antifungal drugs may be necessary
because patients diagnosed with
invasive aspergillosis and
mucuromycosis and treated as
31 Walsh TJ, Anaissie EJ, Denning DW, Herbrecht
R, Kontoyiannis DP, Marr KA, et al. Treatment of
aspergillosis: Clinical practice guidelines of the
Infectious Diseases Society of America. Clin Infect
Dis. 2008;46:327-60.
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inpatients are often severely ill and may
not be able to tolerate any food or
medications orally. We are seeking
public comments on whether or not
CRESEMBA® meets the substantial
clinical improvement criterion,
specifically taking into consideration
our concerns described above.
We did not receive any written public
comments in response to the New
Technology Town Hall Meeting
regarding the application for
CRESEMBA® for new technology addon payments.
f. Idarucizumab
Boehringer Ingelheim
Pharmaceuticals, Inc. submitted an
application for new technology add-on
payments for Idarucizumab, a product
developed as an antidote to reverse the
effects of PRADAXA® (Dabigatran),
which is also manufactured by
Boehringer Ingelheim Pharmaceuticals,
Inc. Dabigatran is an oral direct
thrombin inhibitor currently indicated
to: (1) Reduce the risk of stroke and
systemic embolism in patients who have
been diagnosed with nonvalvular atrial
fibrillation (NVAF); (2) treat deep
venous thrombosis (DVT) and
pulmonary embolism (PE) in patients
who have been administered a
parenteral anticoagulant for 5 to 10
days; and (3) reduce the risk of
recurrence of DVT and PE in patients
who have been previously diagnosed
with NVAF. Currently, unlike the
anticoagulant Warfarin, there is no
specific way to reverse the anticoagulant
effect of Dabigatran in the event of a
major bleeding episode.
Idarucizumab is a humanized
fragment antigen binding (Fab)
molecule, which specifically binds to
Dabigatran to deactivate the
anticoagulant effect, thereby allowing
thrombin to act in blood clot formation.
The applicant stated that Idarucizumab
represents a new pharmacologic
approach to neutralizing the specific
anticoagulant effect of Dabigatran in
emergency situations. If FDA approval
is granted, Idarucizumab would be the
only FDA-approved therapy available to
neutralize the anticoagulant effect of
Dabigatran. The current approach for
the management of the anticoagulant
effect of Dabigatran prior to an invasive
procedure is to withhold administration
of Dabigatran, when possible, for a
certain duration of time prior to the
procedure to allow sufficient time for
the patient’s kidneys to flush out the
medication. The duration of time
needed to flush out the medication prior
to the surgical procedure is based on the
patient’s kidney function. According to
the applicant, if surgery cannot be
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delayed to allow the kidneys the
necessary time to flush out the traces of
Dabigatran, there is an increased risk of
bleeding.
Based on the proposed FDA
indication for Idarucuzimab, the
product can be used in the treatment of
patients who have been diagnosed with
NVAF and administered Dabigatran to
reverse life-threatening bleeding events,
or who require emergency surgery or
medical procedures and rapid reversal
of the anticoagulant effects of
Dabigatran is necessary and desired. As
of this date, Idarucuzimab has not
received approval from the FDA.
However, in June 2014, the FDA granted
Idarucizumab Breakthrough Therapy
Designation. In addition, the applicant
plans to seek Fast Track Designation
from the FDA. Currently, there are no
specific ICD–9–CM or ICD–10–PCS
procedure codes that describe the use of
Idarucizumab. As stated above, effective
October 1, 2015 (FY 2016), the ICD–10
coding system will be implemented.
The applicant submitted a request for
unique ICD–10–PCS codes that was
presented at the March 18, 2015 ICD–10
Coordination and Maintenance
Committee meeting. If approved, the
codes will be effective on October 1,
2015 (FY 2016). More information on
this request can be found on the CMS
Web site at: https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
We are inviting public comments on
whether Idarucizumab meets the
newness criterion.
With regard to the cost criterion, the
applicant conducted four analyses. The
applicant began by researching the FY
2013 MedPAR file for cases that may be
eligible for Idarucizumab using a
combination of ICD–9–CM diagnosis
and procedure codes. Specifically, the
applicant searched the database for
cases reporting anticoagulant therapy
diagnosis codes E934.2 (Agents
primarily affecting blood constituents,
anticoagulants) or V58.61 (Long-term
(current) use of anticoagulants) in
combination with either current
standard of care procedure codes 99.03
(Other transfusion of whole blood),
99.04 (Transfusion of packed cells),
99.05 (Transfusion of platelets), 99.06
(Transfusion of coagulation factors),
99.07 (Transfusion of other serum), or
39.95 (Hemodialysis), and Dabigatran
indication diagnosis codes 427.31
(Atrial fibrillation), 453.40 (Acute
venous embolism and thrombosis of
unspecified deep vessels of lower
extremity), 453.41 (Acute venous
embolism and thrombosis of deep
vessels of proximal lower extremity),
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453.42 (Acute venous embolism and
thrombosis of deep vessels of distal
lower extremity), 453.50 (Chronic
venous embolism and thrombosis of
unspecified deep vessels of lower
extremity), 453.51 (Chronic venous
embolism and thrombosis of deep
vessels of proximal lower extremity),
453.52 (Chronic venous embolism and
thrombosis of deep vessels of distal
lower extremity), 415.11 (Iatrogenic
pulmonary embolism and infarction),
415.12 (Septic pulmonary embolism),
415.13 (Saddle embolus of pulmonary
artery), 415.19 (Other pulmonary
embolism and infarction), 416.2
(Chronic pulmonary embolism), V12.51
(Personal history of venous thrombosis
and embolism), or V12.55 (Personal
history of pulmonary embolism).
To further target potential cases that
may be eligible for Idarucizumab, the
applicant also excluded specific cases
based on Dabigatran contraindications,
including all cases representing patients
who have been diagnosed with chronic
kidney disease (CKD) stage V (diagnosis
code 585.5), end-stage renal disease
(diagnosis code 585.6), prosthetic heart
valves (diagnosis code V43.3), and cases
representing patients who have been
diagnosed with both CKD stage IV
(diagnosis code 585.4) and either DVT
or PE (using the same ICD–9–CM
diagnosis codes listed above). As a
result, the applicant identified 103,752
cases that mapped to 694 MS–DRGs.
The applicant standardized the charges
and computed an average case-weighted
standardized charge per case of $57,611.
The applicant then identified hospital
charges potentially associated with the
current treatments to reverse
anticoagulation, specifically charges
associated with pharmacy services,
dialysis services, and laboratory services
for blood work. Due to limitations
associated with the claims data, the
applicant was unable to determine the
specific drugs used to reverse
anticoagulation and if these cases
represented patients who required
laboratory services for blood work or
dialysis services unrelated to the
reversal of anticoagulation. Therefore,
the applicant subtracted 40 percent of
the charges related to these three
categories from the standardized charge
per case, based on the estimation that
the full amount of charges associated
with these services would not be
incurred by hospitals if Idarucizumab is
approved and available for use in the
treatment of patients who have been
diagnosed with NVAF and administered
Dabigatran during treatment. The
applicant then inflated the standardized
charge per case by 10.4227 percent, the
same inflation factor used by CMS to
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Sfmt 4702
24445
update the FY 2015 outlier threshold
(79 FR 50379). This resulted in an
inflated average case-weighted
standardized charge per case of $59,582.
Using the FY 2015 IPPS Table 10
thresholds, the average case-weighted
threshold amount across all 694 MS–
DRGs is $54,850 (all calculations above
were performed using unrounded
numbers). Because the inflated average
case-weighted standardized charge per
case exceeds the average case-weighted
threshold amount, the applicant
maintained that the technology meets
the cost criterion under this analysis.
The applicant also performed a
similar analysis by using the same data
from the FY 2013 MedPAR file and
subtracting 60 percent of the charges
associated with pharmacy services,
dialysis services, and laboratory services
for blood work. This resulted in an
inflated average case-weighted
standardized charge per case of $57,560.
Using the FY 2015 IPPS Table 10
thresholds, the average case-weighted
threshold amount across all 694 MS–
DRGs is $54,850 (all calculations above
were performed using unrounded
numbers). Because the inflated average
case-weighted standardized charge per
case for the applicable MS–DRGs
exceeds the average case-weighted
threshold amount, the applicant
maintained that the technology also
meets the cost criterion under this
analysis.
Further, the applicant conducted two
additional analyses using the same data
from the FY 2013 MedPAR file and
variables used in the previous analyses.
However, instead of using potentially
eligible cases that mapped to 100
percent of the 694 MS–DRGs identified,
the applicant used potentially eligible
cases that mapped to the top 75 percent
of the 694 MS–DRGs identified. By
applying this limitation, the applicant
identified 77,667 cases that mapped to
92 MS–DRGs. Under the analysis’
variable that subtracted 40 percent of
the charges associated with the current
treatments to reverse anticoagulation,
the applicant computed an inflated
average case-weighted standardized
charge per case of $56,627. Under the
analysis’ variable that subtracted 60
percent of the charges associated with
the current treatments to reverse
anticoagulation, the applicant computed
an inflated average case-weighted
standardized charge per case of $54,677.
Using the FY 2015 IPPS Table 10
thresholds, the average case-weighted
threshold amount across all 92 MS–
DRGs using both scenarios is $53,008
(all calculations above were performed
using unrounded numbers). Because the
inflated average case-weighted
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standardized charge per case exceeds
the average case-weighted threshold
amount, the applicant maintained that
the technology also meets the cost
criterion under these variant analyses.
The applicant noted that the inflated
average case-weighted standardized
charge per case computed using all four
scenarios did not include any charges
for Idarucizumab. Therefore, the
applicant maintained that the
technology would also meet the cost
criterion if charges for Idarucizumab
were included because the inflated
average case-weighted standardized
charge per case would increase and
further exceed the average caseweighted threshold amount using the
variables of all four analyses. We are
inviting public comments regarding the
applicant’s analyses with respect to the
cost criterion.
With regard to substantial clinical
improvement, according to the
applicant, there are currently no specific
FDA-approved antidotes to reverse the
anticoagulant effects of Dabigatran.
Management of the treatment of patients
who have been diagnosed with NVAF
and administered Dabigatran and
experience bleeding may often include
supportive care such as Hemodialysis
and the use of fresh frozen plasma,
blood factor products such as
prothrombin complex concentrates
(PCC), activated prothrombin complex
concentrates, and recombinant factor
VIIa or delayed intervention. Protamine
sulfate and Vitamin K are typically used
to reverse the effects of Heparin and
Warfarin, respectively. However, due to
the mechanism of action in Dabigatran,
the applicant maintained that the use of
protamine sulfate and Vitamin K may
not be effective to reverse the
anticoagulant effect of Dabigatran.
The applicant provided information
regarding the management of major
bleeding events experienced by patients
who were administered Dabigatran and
Warfarin during the RE-LY trial.32
During this study, most major bleeding
events were only managed by
supportive care. Patients who were
administered 150 mg of Dabigatran were
transfused with pack red blood cells
more often when compared to patients
who were administered Warfarin (61.4
percent versus 49.9 percent,
respectively). However, patients who
were administered Warfarin were
transfused with plasma more often
when compared to patients who were
32 Healy, et al.: Periprocedural bleeding and
thromboembolic events with dabigatran compared
with warfarin: results from the randomized
evaluation of long-term anticoagulation therapy
(RE-LY) randomized trial, Circulation, 2012;
126:343–348.
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18:20 Apr 29, 2015
Jkt 235001
administered 150 mg of Dabigatran (30.2
percent versus 21.6 percent,
respectively). In addition, the use of
Vitamin K in the treatment of patients
who were administered Warfarin was
more frequent when compared to the
frequency of use in the treatment of
patients who were administered 150 mg
of Dabigatran (27.3 percent versus 10.3
percent, respectively). The use of PCCs,
recombinant factor VIIa and other
coagulation factor replacements in the
treatment of patients who were
administered both Warfarin and 150 mg
of Dabigatran was minimal, and did not
significantly differ in frequency when
compared among patients assigned to
either group. Hemodialysis was used in
a single case.
The applicant reported that, currently,
it is recommended that the
administration of Dabigatran be
discontinued 1 to 2 days (CrCl ≥50 ml/
min) or 3 to 5 days (CrCl <50 ml/min),
if possible, before invasive or surgical
procedures because of the increased risk
of bleeding.33 A longer period of
discontinuation time should be
considered for patients undergoing
major surgery, spinal puncture, or
placement of a spinal or epidural
catheter or port, if complete hemostasis
is required. The applicant stated that
delaying emergency medical or surgical
procedures can cause urgent conditions
to become more severe if intervention is
not initiated. The applicant further
maintained that delaying emergency
medical or surgical procedures for an
extended period of time can ultimately
lead to negative healthcare outcomes
and increased healthcare costs. The
applicant asserted that rapidly reversing
the anticoagulant effect of Dabigatran
administered to patients that require an
urgent medical procedure or surgery
allows the medical procedure or surgery
to be performed in a timely manner,
which in turn may decrease
complications and minimize the need
for more costly therapies.
The applicant noted that
Idarucizumab was shown to neutralize
the anticoagulant effect of Dabigatran in
both animal models and healthy human
volunteers.34 In a swine blunt liver
trauma injury model, the applicant
stated that Idarucizumab effectively
reversed life-threatening bleeding
episodes resulting from trauma in pigs.
33 Pradaxa® (Dabigatran Etexilate Mesylate)
prescribing information. Ridgefield, CT: Boehringer
Ingelheim; 2014.
34 Honickel, et al.: Reversal of dabigatran
anticoagulation ex vivo: Porcine study comparing
prothrombin complex concentrates and
idarucizumab, Thrombosis and Hemostasis,
International Journal for Vascular Biology and
Medicine, Vol. 113, April 2015.
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The applicant also provided data from
a randomized, double-blind, placebocontrolled phase I study of healthy male
volunteers to investigate the safety,
tolerability, and pharmacokinetics of
administering single rising doses of
Idarucizumab (Part 1) and explore the
variant of dosages of Idarucizumab
administered to patients that effectively
reversed the anticoagulant effect of
Dabigatran (Part 2). Safety data is
limited in humans to 110 healthy male
patients enrolled in the study that were
administered dosages of Idarucizumab
that ranged from 20 mg to 8 grams. In
this study, 135 patients received
placebo. The applicant reported that
adverse events were generally mild in
intensity and non-specific. Healthy
human volunteers enrolled in the phase
I study (1321.1) were administered
Idarucizumab in dosages of 2 and 4
grams, which resulted in immediate and
complete reversal of the anticoagulant
effect of Dabigatran that was sustained
for several hours. The applicant noted
that in preclinical studies, the reversal
of the anticoagulant effects of
Dabigatran was associated with the
reversal of bleeding. These effects were
consistent in animal models of renal
dysfunction, hypovolemia and shock,
and trauma related bleeding. The
applicant concluded that the data from
these studies demonstrates that
Idarucizumab effectively, safely, and
potently reverses the anticoagulant
effect of Dabigatran in both animal
models and healthy human volunteers.
With regard to the substantial clinical
improvement criterion, we believe that
Idarucizumab, if approved by the FDA,
may represent a treatment option that is
not currently available to Medicare
beneficiaries and, therefore, represents a
substantial clinical improvement.
However, we are concerned that the
clinical data are not sufficient.
Specifically, the applicant provided
data from an animal model. In addition,
the primary clinical data in relation to
human volunteers are based primarily
on a trial to measure safety. While the
applicant did provide clinical data on
the effectiveness of Idarucizumab, we
are concerned that the evidence
presented does not support the
substantial clinical improvement
criterion. Specifically, the applicant
provided data from a small sample used
to demonstrate effectiveness. Usually
during clinical studies, phase III of a
clinical trial is typically used to gather
data from a larger patient population to
demonstrate effectiveness. We are
inviting public comments on whether or
not Idarucizumab meets the substantial
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clinical improvement criterion,
specifically in regard to these concerns.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
g. LUTONIX® Drug-Coated Balloon
(DCB) Percutaneous Transluminal
Angioplasty (PTA) Catheter and
IN.PACTTM AdmiralTM Paclitaxel
Coated Percutaneous Transluminal
Angioplasty (PTA) Balloon Catheter
Two manufacturers, CR Bard Inc. and
Medtronic, submitted applications for
new technology add-on payments for FY
2016 for LUTONIX® Drug-Coated
Balloon (DCB) Percutaneous
Transluminal Angioplasty (PTA)
Catheter (LUTONIX®) and IN.PACTTM
AdmiralTM Paclitaxel Coated
Percutaneous Transluminal Angioplasty
(PTA) Balloon Catheter (IN.PACTTM
AdmiralTM), respectively. Both of these
technologies are drug-coated balloon
angioplasty treatments for patients
diagnosed with peripheral artery disease
(PAD). Typical treatments for patients
with PAD include angioplasty, stenting,
atherectomy and vascular bypass
surgery. PAD most commonly occurs in
the femoropopliteal segment of the
peripheral arteries, is associated with
significant levels of morbidity and
impairment in quality of life, and
requires treatment to reduce symptoms
and prevent or treat ischemic events.35
Treatment options for symptomatic PAD
include noninvasive treatment such as
medication and life-style modification
(for example, exercise programs, diet,
and smoking cessation) and invasive
options which include endovascular
treatment and surgical bypass. The 2013
American College of Cardiology and
American Heart Association (ACC/
AHA) guidelines for the management of
PAD recommend endovascular therapy
as the first-line treatment for
femoropopliteal artery lesions in
patients suffering from claudication
(Class I, Level A recommendation).36
The applicants for LUTONIX® and
IN.PACTTM AdmiralTM stated that, in
patients diagnosed with PAD, the
femoropopliteal artery is characterized
by difficult to treat lesions that can be
long and diffuse, in a vessel that is
considered the most mechanically
35 Tepe G, Zeller T, Albrecht T, Heller S,
¨
Schwarzwalder U, Beregi JP, Claussen CD,
Oldenburg A, Scheller B, Speck U.: Local delivery
of paclitaxel to inhibit restenosis during angioplasty
of the leg. N Engl J Med 2008; 358: 689–99.
36 Anderson JL, Halperin JL, Albert NM, Bozkurt
B, Brindis RG, Curtis LH, DeMets D, Guyton RA,
Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ,
Sellke FW, Shen WK.: Management of patients with
peripheral artery disease (compilation of 2005 and
2011 ACCF/AHA guideline recommendations): a
report of the American College of Cardiology
Foundation/American Heart Association Task Force
on Practice Guidelines. J Am Coll Cardiol 2013;
61:1555–70. Available at: https://dx.doi.org/10.1016/
j.jacc.2013.01.004.
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18:20 Apr 29, 2015
Jkt 235001
stressed artery with a number of
dynamic forces that impact the artery
including shortening/elongation,
torsion, compression and flexion.
According to the applicants, the unique
challenges of treating the
femoropopliteal artery in patients
diagnosed with PAD relate to
insufficient outcomes from current
endovascular therapies, in particular
PTA and stent implantations. Coating of
femoral and coronary stents with an
antiproliferative drug, such as
paclitaxel, sirolimus, everolimus, or
zotarolimus, that is slowly released
when it comes in contact with the
arterial wall, is intended to reduce
development of restenosis in the stented
segment of the artery.37 38
The applicants noted that drug-coated
balloon catheters are designed to deliver
an antiproliferative drug directly to the
arterial segment being dilated. Rather
than using a stent to deliver the drug
slowly to the dilated area, the drug
coating of a balloon is designed to
transfer the drug to the arterial wall by
direct contact over a few minutes. The
applicant maintained that if the drug is
absorbed into the arterial wall, rather
than being washed away by blood flow
once the balloon is deflated, the drug
can exert its antiproliferative effects on
the vessel with the goal of preventing
restenosis.
The applicants stated that the drugcoated balloon catheter is a device-drug
combination product comprised of a
device component (an over-the-wire
balloon catheter) and a drug component
(a paclitaxel-urea coating in the case of
IN.PACTTM and a paclitaxel- sorbitol for
LUTONIXTM AdmiralTM) on the balloon,
intended for the treatment of patients
with PAD, specifically superficial
femoral artery (SFA) and popliteal
artery disease. The device is engineered
for two modes of action: the primary
mode of action is attributable to the
balloon’s mechanical dilatation of de
novo or restenotic lesions in the vessel;
and the secondary mode of action
consists of drug delivery and
application of paclitaxel to the vessel
wall to inhibit the restenosis that is
normally associated with the
proliferative response to the PTA
procedure. Following predilatation with
a nondrug-coated PTA balloon, the
interventionalist selects a drug-coated
balloon with diameter of 100 percent of
reference vessel diameter (RVD) and
length sufficient to treat 5mm proximal
37 Owens, CD.: Drug eluting balloon overview:
technology and therapy. Presented at LINC 2011,
Leipzig, Germany.
38 Scheller B.: Opportunities and limitations of
drug-coated balloon in interventional therapies.
Herz 2011;36:232–40.
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24447
and distal to the target lesion and
predilated segment (including overlap
of multiple balloons). The
interventionalist inflates the drugcoated balloon for a minimum inflation
time of 30 seconds for delivery of
paclitaxel, and keeps the balloon
inflated for as long as necessary to
achieve a satisfactory procedural result,
which is the standard of care for all
balloon angioplasties.
According to both applicants,
LUTONIX® and IN.PACTTM AdmiralTM
are the first drug coated balloons that
can be used for treatment of patients
who are diagnosed with PAD. Because
cases eligible for the two devices would
group to the same MS–DRGs and we
believe that these devices are
substantially similar to each other (that
is, they are intended to treat the same
or similar disease in the same or similar
patient population and are purposed to
achieve the same therapeutic outcome
using the same or similar mechanism of
action), we believe that it is appropriate
to evaluate both technologies as one
application for new technology add-on
payment under the IPPS. The applicants
submitted separate cost and clinical
data, and we reviewed and discuss each
set of data separately. However, we
intend to make one determination
regarding new technology add-on
payments that will apply to both
devices. We believe that this is
consistent with our policy statements in
the past regarding substantial similarity.
Specifically, we have noted that
approval of new technology add-on
payments would extend to all
technologies that are substantially
similar (66 FR 46915), and that we
believe that continuing our current
practice of extending a new technology
add-on payment without a further
application from the manufacturer of
the competing product or a specific
finding on cost and clinical
improvement if we make a finding of
substantial similarity among two
products is the better policy because we
avoid—
• Creating manufacturer-specific
codes for substantially similar products;
• Requiring different manufacturers
of substantially similar products from
having to submit separate new
technology applications.
• Having to compare the merits of
competing technologies on the basis of
substantial clinical improvement; and
• Bestowing an advantage to the first
applicant representing a particular new
technology to receive approval. (70 FR
47351)
If these substantially similar
technologies had been submitted for
review in different (and subsequent)
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years, rather than the same year, we
would evaluate and make a
determination on the first application
and apply that same determination to
the second application. However,
because the technologies have been
submitted for review in the same year,
we believe it is appropriate to consider
both sets of cost data and clinical data
in making a determination because we
do not believe that it is possible to
choose one set of data over another set
of data in an objective manner.
CR Bard, Inc. received FDA approval
for LUTONIX® on October 9, 2014.
Commercial sales in the U.S. market
began on October 10, 2014. Medtronic
received FDA approval for IN.PACTTM
AdmiralTM on December 30, 2014.
Commercial sales in the U.S. market
began on January 29, 2015. As stated in
section II.G.1.a. of the preamble of this
proposed rule, effective October 1, 2015
(FY 2016), the ICD–10 coding system
will be implemented. We note that the
applicant submitted a request and
presented at the September 2014 ICD–10
Coordination and Maintenance
Committee Meeting to create ICD–10–
PCS codes to uniquely identify drugcoated PTA balloons used for treating
ICD–10–PCS code
047K041
047K0D1
047K0Z1
047K341
047K3D1
047K3Z1
047K441
.......................
.......................
.......................
.......................
.......................
.......................
.......................
047K4D1 .......................
047K4Z1 .......................
047L041 ........................
047L0D1 .......................
047L0Z1 ........................
047L341 ........................
047L3D1 .......................
047L3Z1 ........................
047L441 ........................
047L4D1 .......................
047L4Z1 ........................
047M041 .......................
047M0D1 ......................
047M0Z1 .......................
047M341 .......................
047M3D1 ......................
047M3Z1 .......................
047M441 .......................
047M4D1 ......................
047M4Z1
047N041
047N0D1
047N0Z1
047N341
047N3D1
047N3Z1
047N441
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
047N4D1 .......................
047N4Z1 .......................
Code description
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, open approach.
Dilation of right femoral artery using drug-coated balloon, open approach.
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous
endoscopic approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right femoral artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, open approach.
Dilation of left femoral artery using drug-coated balloon, open approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic
approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left femoral artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, open approach.
Dilation of right popliteal artery using drug-coated balloon, open approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous
endoscopic approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right popliteal artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, open approach.
Dilation of left popliteal artery using drug-coated balloon, open approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous
endoscopic approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left popliteal artery using drug-coated balloon, percutaneous endoscopic approach.
As we discuss above, the approval of
new technology add-on payments
would extend to all technologies that
are substantially similar. Otherwise, our
payment policy would bestow an
advantage to the first applicant to
receive approval for a particular new
technology (66 FR 46915). Moreover, as
we discuss above, we believe that
VerDate Sep<11>2014
PAD. More information on this request
can be found on the CMS Web site at:
https://www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
We received public comments during
and after the ICD–10 Coordination and
Maintenance Committee meeting that
supported the creation of unique codes
to identify the use of a drug-coated
balloon in procedures performed for
treating PAD. As a result, the following
ICD–10–PCS codes listed in the table
below were created and are effective
October 1, 2015 (FY 2016):
18:20 Apr 29, 2015
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applications for substantially similar
technologies should be evaluated in a
manner that avoids, among other things,
having to compare the merits of
competing technologies on the basis of
substantial clinical improvement. If we
receive applications for substantially
similar technologies in different years,
we would apply the first determination
PO 00000
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to any subsequent applications for
substantially similar technologies.
However, because, in this case, two
substantially similar technologies have
applied for a new technology add-on
payment for the same Federal fiscal
year, we believe it is consistent with our
policy to make one determination using
all of the information submitted for the
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technologies rather than choosing one
set of information to consider and not
considering the other set of information.
We believe that, in accordance with our
policy, it is appropriate to use the
earliest market availability date
submitted as the beginning of the
newness period. Accordingly, for both
devices, based on our policy, if
approved for new technology add-on
payments, we believe that the beginning
of the newness period would be October
10, 2014. We are inviting public
comments on whether these two
technologies meet the newness
criterion.
As we stated above, each applicant
submitted separate analyses regarding
the cost criterion for each of their
devices and both applicants maintained
that their device meets the cost
criterion. We summarize each analysis
below.
With regard to LUTONIX®, to
demonstrate that the technology meets
the cost criterion, the applicant
performed three different analyses. The
applicant first searched the FY 2013
MedPAR data file that was used for the
recalibration of the FY 2015 MS–DRG
relative payment weights in the FY 2015
IPPS/LTCH PPS final rule. The
applicant applied the standard trims
that CMS used when selecting cases for
IPPS rate recalibration as described in
the FY 2015 IPPS/LTCH PPS final rule
(79 FR 49911). In other words, the
applicant included cases from IPPS
hospitals and Maryland hospitals and
excluded cases paid by Medicare
Advantage plans, cases from hospitals
that did not submit charges in a
sufficiently broad range of revenue
centers, and statistical outlier cases as
described in the FY 2015 IPPS/LTCH
PPS final rule. The applicant then
searched for all claims reporting ICD–9–
CM procedure code 39.50 (Angioplasty
of other non-coronary vessel(s)) and also
reporting at least one of the following
seven ICD–9–CM diagnosis codes
(440.20 (Atherosclerosis of native
arteries of the extremities, unspecified),
440.21 (Atherosclerosis of native
arteries of the extremities with
intermittent claudication), 440.22
(Atherosclerosis of native arteries of the
extremities with rest pain), 440.23
(Atherosclerosis of native arteries of the
extremities with ulceration), 440.24
(Atherosclerosis of native arteries of the
extremities with gangrene), 440.29
(Other atherosclerosis of native arteries
of the extremities), and 443.9
(Peripheral vascular disease,
unspecified indicating peripheral artery
disease). The applicant excluded all
claims that reported any ICD–9–CM
procedure codes involving a stent. A
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18:20 Apr 29, 2015
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total of 23,157 cases reporting
peripheral angioplasty were identified.
Of these 23,157 cases, MS–DRGs 252,
253, and 254 (Other Vascular
Procedures with MCC, with CC and
without CC/MCC, respectively)
accounted for 65 percent of cases; MS–
DRGs 237 and 238 (Major
Cardiovascular Procedures with MCC
and without MCC, respectively), MS–
DRGs 239 and 240 (Amputation for
Circulatory System Disorders Except
Upper Limb and Toe with MCC and
with CC, respectively), and MS–DRG
853 (Infectious and Parasitic Diseases
with Operating Room Procedure with
MCC) accounted for 17 percent of cases
(among these, peripheral angioplasty
was secondary to some other
circulation-related procedure: a major
cardiovascular procedure (MS–DRGs
237 and 238), amputation due to poor
circulation (MS–DRGs 239 and 240), or
(typically) amputation with sepsis (MS–
DRG 853)). The remaining 18 percent of
cases were spread across a large number
of other MS–DRGs. Next, the applicant
obtained the average case-weighted
charge per case based on the
distribution of cases by MS–DRG and
then identified the average caseweighted threshold for the three MS–
DRG groupings from the threshold
amounts in Table 10 of the FY 2015
IPPS/LTCH PPS final rule. The
applicant then calculated the
unadjusted (unstandardized) average
case-weighted charge per case for all
MS–DRGs. According to the applicant,
charges were not removed for any prior
technology. To estimate the charge for
the new technology, the applicant
divided the projected cost per patient by
the national average CCR for supplies
(0.292) in the FY 2015 IPPS/LTCH PPS
final rule, to arrive at the average caseweighted standardized charges per case.
The average case-weighted standardized
charges per case for the three primary
MS–DRGs 252–254 group (65 percent),
the five additional MS–DRGs 237–240
and MS–DRG 853 group (17 percent),
and the other MS–DRGs (18 percent)
were $69,243, $81,156, and $95,138,
respectively. The applicant then inflated
the average standardized case-weighted
charges per case from FY 2013 to FY
2015 using the 2-year inflation factor of
10.44 percent specified in the FY 2015
IPPS/LTCH PPS final rule and added
charges related to the new technology to
the average case-weighted standardized
charges per case, although the applicant
indicated that it was not clear on the
need to include an inflation factor. The
final inflated average case-weighted
standardized charges per case for the
three primary MS–DRG groups (65
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percent), the five additional MS–DRG
groups (17 percent), and across other
MS–DRGs (18 percent) were $85,386,
$98,543, and $104,052, respectively.
Because the final inflated average caseweighted standardized charge amounts
exceed the corresponding average caseweighted threshold amounts of $69,594,
$74,449, and $75,215, respectively,
using the FY 2015 IPPS Table 10, the
applicant maintained that the
LUTONIX® meets the cost criterion for
new technology add-on payments.
With regard to IN.PACTTM
AdmiralTM, to demonstrate that the
technology meets the cost criterion, the
applicant performed two different
analyses. The applicant believed that a
case involving an angioplasty procedure
that used the IN.PACTTM AdmiralTM
drug-coated balloon catheter would map
to the same MS–DRGs as a case
involving a plain balloon angioplasty
procedure, MS–DRGs 252, 253, and 254
(Other Vascular Procedures with MCC,
with CC, and without CC/MCC,
respectively). The applicant first
searched the FY 2013 MedPAR claims
data that were used for the recalibration
of the FY 2015 MS–DRG relative
payment weights in the FY 2015 IPPS/
LTCH PPS final rule. The data in this
file included discharges occurring on
October 1, 2012 through September 30,
2013. The applicant excluded claims for
all discharges for Medicare beneficiaries
enrolled in a Medicare Advantage plan.
The applicant also limited claims to
those hospitals that were included in
the FY 2013 IPPS Final Rule Impact
File. In addition, the applicant removed
claims in accordance with the trims
specified in the FY 2013 IPPS/LTCH
PPS final rule (77 FR 53326) that were
used to recalibrate the MS–DRG relative
payment weights. The applicant then
searched for all claims reporting ICD–9–
CM procedure code 39.50 (Angioplasty
of other non-coronary vessel(s)) in
combination with claims reporting at
least one of the following seven ICD–9–
CM diagnosis codes (440.20 through
440.24, 440.29, and 443.9) indicating
peripheral artery disease. The applicant
excluded all claims that reported any
ICD–9–CM procedure codes for stent
implantation. The applicant believed
that excluding all cases reporting
stenting procedures would potentially
underestimate the average charges for
cases reporting peripheral angioplasty.
A total of 23,157 cases involving
peripheral angioplasty procedures were
identified. Of these 23,157 cases, a
majority (65 percent; 15,040 cases)
mapped to one of the 3 primary MS–
DRGs, MS–DRGs 252, 253, or 254. The
remaining 35 percent of the cases
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(8,117) were assigned to a number of
MS–DRGs other than the 3 primary MS–
DRGs. Next, the applicant determined
the distribution of cases by MS–DRG
and the case-weighted threshold
amounts from Table 10 in the FY 2015
IPPS/LTCH PPS final rule, for both the
primary MS–DRG group and the total
MS–DRG group. The applicant began by
calculating the unadjusted
(unstandardized) case-weighted average
charge per case for all MS–DRGs.
Following this computation, the
applicant standardized the charges on
each of the identified claims using the
FY 2013 factors from the FY 2015 IPPS/
LTCH PPS Final Rule Impact File, to
match the year of the claims data used
in this analysis (FY 2013 MedPAR file).
According to the applicant, charges
were not removed for any other specific
technologies that may have been used
because the applicant expected that a
plain balloon will be utilized to
predilate the vessel in a majority of
drug-coated balloon angioplasty cases
prior to the use of the drug-coated
balloon (that is, the applicant did not
believe it was necessary to remove
charges associated with the other
specific prior technology (a plain PTA
balloon catheter in this case). The
applicant then inflated the average caseweighted standardized charges per case
from FY 2013 to FY 2015 using the 2year inflation factor of 10.44 percent
specified in the FY 2015 IPPS/LTCH
PPS final rule and added charges related
to the new technology to the average
charges per case. The final inflated
average case-weighted standardized
charge per case both for the primary
MS–DRGs group and the total MS–DRG
group were $82,944 and $101,611,
respectively. Because the final inflated
average case-weighted standardized
charge per case for the applicable MS–
DRG exceeds the average case-weighted
threshold amounts of $69,594 and
$75,215, respectively, using the FY 2015
IPPS Table 10, the applicant maintained
that the IN.PACTTM AdmiralTM
technology meets the cost criterion for
new technology add-on payments.
We are concerned that both applicants
excluded cases of patients that received
stent implantations from their analysis
because the applicants believed that
their technology can be used instead of
stenting. We are seeking public
comments on whether LUTONIX® and
IN.PACTTM AdmiralTM meet the cost
criterion.
With regard to substantial clinical
improvement, the applicant believed
that LUTONIX® represents a substantial
clinical improvement because it meets
an unmet clinical need by providing
access to ‘‘no stent zones’’ and because
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it can achieve greater patency; preserve
the flexibility of future interventions;
and address stent fractures and restenosis.39 40
The applicant shared the findings
from its LEVANT 1 and LEVANT 2
trials.
LEVANT 1: In the LEVANT 1 trial,
101 patients were randomized to a
LUTONIX® drug-coated balloon
treatment group or a control group that
received percutaneous transluminal
angioplasty (PTA) only. The primary
endpoint of mean angiographic Late
Lumen Loss at 6 months favored the
LUTONIX® drug-coated balloon
treatment group (0.46±1.13) compared
to the control PTA group (1.09±1.07),
with a p-value of 0.016.
We are concerned that the results
were not statistically significant with
regard to the p-value documented.
Adverse events were similar for both
groups and through 24 months; the
percentage of patients with any death,
amputation, or target vessel thrombosis
was 8 percent in the treatment group
compared to 12 percent in the control
group.
LEVANT 2: The LEVANT 2 study is
the applicant’s pivotal study that was
conducted as a prospective, multicenter,
single blind, 2:1 (test: control)
randomized trial comparing the
LUTONIX® drug-coated balloon
angioplasty to standard balloon
angioplasty used during the treatment of
patients with femoropopliteal arteries.
The applicant documented that the
patient characteristics and lesions in
both groups were well-matched; 43
percent of patients were diabetic; 35
percent were current smokers; 37
percent were female; and 8 percent had
critical limb ischemia.
The study was conducted to show
that drug-coated balloon angioplasty
improves clinical outcomes for a patient
population as compared to currently
available treatments. All endpoints were
adjudicated by a blinded Clinical Events
Committee (CEC) and duplex ultrasound
and angiographic core laboratories.
The applicant specified two primary
endpoints that must both be met in
order for the study to be successful. The
first endpoint was primary patency at 12
months, defined as freedom from target
lesion restenosis and target lesion
revascularization (TLR). The results
were the following: primary patency for
LUTONIX® was 65.2 percent compared
39 Scheinert, D., et al.: Prevalence and clinical
impact of stent fractures after femoropopliteal
stenting. J Am Coll Cardiol, 2005. 45(2): p. 312–5.
40 Klein, A.J., et al.: Quantitative assessment of
the conformational change in the femoropopliteal
artery with leg movement. Catheter Cardiovasc
Interv, 2009. 74(5): p. 787–98.
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to primary patency of 52.6 percent for
PTA. Kaplan-Meier analysis was 73.5
percent for LUTONIX® compared to
56.8 percent for PTA (p <0.001). The
second primary efficacy endpoints were
composite safety endpoints at 12
months, which included freedom from
index-limb amputation; reintervention
and related death. The results were 83.9
percent for LUTONIX® compared to
79.0 percent for PTA.
The secondary efficacy endpoints at
12 months for this trial were freedom
from Target lesion revascularization
(TLR), and the results were 89.7 percent
for the LUTONIX® treatment group
compared to 84.8 percent for the PTA
control group, with p = 0.17. Another
end point was freedom from Target
vessel revascularization (TVR), where
the result for the LUTONIX® treatment
group was 76.2 percent compared to
66.6 percent in the control group with
a p-value of 0.041. Clinical indicators,
such as Ankle brachial index (ABI),
Rutherford scores (categorization of
symptomology), quality of life (QOL),
walking distance, and walking
impairment WIQ, were significantly
improved with a p-value of <0.001. The
applicant assessed the primary safety
endpoint using Kaplan-Meier survival
analysis and stated that there was no
evidence of statistical difference.
We are concerned that the patient
population studied may not reflect the
Medicare population. In particular, we
note that only 37 percent of the studied
patients were female. For instance, it
could be beneficial to see additional
subgroup analyses to test for statistical
interaction between treatment and
subgroups to ascertain that there is no
imbalance in response to different
subpopulations, such as males versus
females.
With regard to substantial clinical
improvement for the IN.PACTTM
AdmiralTM, the applicant stated that
evidence demonstrates that the
technology significantly improves key
clinical outcomes compared to previous
technologies for patients with
intermittent claudication. Examples of
such key clinical outcomes included a
decrease in recurrence of restenosis
(disease process); a decrease in rates of
repeat interventions (subsequent
therapeutic interventions); a decrease in
future hospitalizations; improved
patient symptoms (decreased pain), and
improvement in quality of life and
function. To further demonstrate
substantial clinical improvement, the
applicant asserted that historical proofof-concept research has demonstrated
the utility of various drug-coated
balloon technologies in reducing
restenosis and reintervention compared
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tkelley on DSK3SPTVN1PROD with PROPOSALS2
with PTA.41 42 With this assertion, the
applicant stated that there was no
evidence of the promising primary
patency and target lesion
revascularization rates from large
randomized controlled trials. This led
the applicant to design the IN.PACTTM
SFA Trial. The IN.PACTTM SFA Trial is
a prospective, randomized-controlled,
global, multicenter, single-blinded study
conducted with independent, blinded
adjudication of all key endpoints. The
primary safety end point was freedom
from device-related and procedurerelated death through 30 days, and
freedom from target limb major
amputation and clinically-driven TVR
through 12 months. The primary
effectiveness endpoint was primary
patency, a composite endpoint
comprising an anatomic measure
(binary restenosis as measured by
duplex ultrasound or angiography) and
a clinical measure (Clinically Driven
Target Lesion Revascularization (CD–
TLR)). The IN.PACTTM SFA Trial was
designed as a two-phase, global,
multicenter trial in which 331 patients
with symptoms of claudication or rest
pain and with a positive diagnostic
finding of de novo stenosis and/or nonstented restenotic lesions in the SFA
and/or popliteal artery (PPA) were
randomized in a 2:1 fashion to treatment
with IN.PACTTM Admiral TM drugcoated balloon or uncoated balloon
angioplasty. The trial was prospectively
designed to be conducted in two phases:
IN.PACTTM SFA Phase I (conducted in
Europe) and IN.PACTTM SFA Phase II
(conducted in the United States), jointly
referred to as IN.PACTTM SFA Trial.
According to the applicant, the patient
demographics were well-matched and of
which 34 percent were women. We are
concerned that the applicant did not
match the gender variable. The
applicant noted that, during the SFA
Trial, both the study subjects and trial
sponsor were blinded to the treatment
assignments through completion of the
12-month primary endpoint evaluations.
The applicant also stated that the
independent Clinical Events Committee
and the Core Laboratories were blinded
to the treatment assignment and the
duration of the follow-up of study
participants. In addition, operators
41 Werk M, Albrecht T, Meyer DR, Ahmed MN,
Behne A, Dietz U, Eschenbach G, Hartmann H,
Lange C, Schnorr B, Stiepani H, Zoccai GB,
¨
Hanninen EL.: Paclitaxel-coated balloons reduce
restenosis after femoropopliteal angioplasty:
evidence from the randomized PACIFIER trial. Circ
Cardiovasc Interv 2012 5: 831–40.
42 Tepe G, Zeller T, Albrecht T, Heller S,
¨
Schwarzwalder U, Beregi JP, Claussen CD,
Oldenburg A, Scheller B, Speck U.: Local delivery
of paclitaxel to inhibit restenosis during angioplasty
of the leg. N Engl J Med 2008; 358: 689–99.
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(implanting physicians and
catheterization laboratory staff,
including research coordinators) were
not blinded to the treatment delivered
due to macroscopic visual differences
between IN.PACTTM AdmiralTM drugcoated balloon and control technology.
The applicant reported the following:
The primary endpoints were: Improved
primary patency rates in the IN.PACTTM
AdmiralTM drug-coated balloon arm
compared to the control arm; and
primary patency within 12 months is
defined as freedom from clinically
driven target lesion revascularization
and freedom from restenosis as
determined by duplex ultrasonography
peak systolic velocity ratio ≤2.4 or ≤50
percent stenosis as assessed by
angiography. Results showed that the
12-month primary patency rate was 82.2
percent in the IN.PACTTM AdmiralTM
drug-coated balloon arm versus 52.4
percent in the PTA arm (P <0.001). In
addition, the 12-month freedom from
binary restenosis (assessed by DUS/
angiography) was 83.5 percent in the
IN.PACTTM AdmiralTM drug-coated
balloon group compared to 66.3 percent
in the PTA group (P = 0.001). The
second endpoint measured was AnkleBrachial Index (ABI) showing 0.951 in
the IN.PACTTM AdmiralTM drug-coated
balloon arm compared to 0.866 in the
control arm, P = 0.002. The ABI is an
objective hemodynamic measure used to
predict the severity of PAD in the lower
extremity. The test is done by
comparing the systolic blood pressure at
the ankle and the systolic blood
pressure in the arm while a person is at
rest. In general, higher values are better
than lower values; a normal resting
ankle-brachial index is from 1.0 to 1.4,
an abnormal resting ankle-brachial
index is 0.9 or lower and an ABI of 0.91
to 0.99 is considered borderline
abnormal.43 Secondary endpoints were
primary sustained clinical
improvement, defined as freedom from
target limb amputation, target vessel
revascularization, and increase in
Rutherford class; comparing IN.PACTTM
AdmiralTM with the control arm was
85.2 percent versus 68.9 percent;
P <0.001. The rate of repeat target lesion
revascularization (TLR), defined by the
applicant as repeat revascularization of
the target lesion by percutaneous
endovascular treatment or bypass
surgery, was 2.4 percent in the
IN.PACTTM AdmiralTM drug-coated
balloon arm compared to 20.6 percent in
43 Hirsch AT, Haskal ZJ, Hertzner NR, et al.: ACC/
AHA guidelines for the management of subjects
with peripheral arterial disease (lower extremity,
renal, mesenteric, and abdominal aorta): executive
summary. J Am Coll Cardiol 2006;47:1239–312.
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the control arm. In addition, the target
vessel revascularization (TVR)
procedures (that is, any
revascularization done to any segment
of the entire target vessel that may
reflect restenosis of a target lesion or
disease progression causing a new
lesion in the target artery) 44 was 4.3
percent in the IN.PACTTM AdmiralTM
drug-coated balloon arm compared to
23.4 percent in the control arm with a
p-value of <0.001).
Other secondary endpoints were
conducted and the patients were
followed at 1, 6, and 12 months to
assess the following claudication
symptoms: EQ–5D; Walking Impairment
Questionnaire (WIQ); 6-minute walk test
in a subset. Claudication symptoms
were 7.3 percent in the IN.PACTTM
AdmiralTM drug-coated balloon arm
compared to 20.7 percent in the control
arm. For WIQ (defined as the ability of
PAD patients to walk defined distances
and speeds, plus climb stairs, thus
evaluating claudication severity
levels 45), the gains in improvement
were similar in both groups. The 6minute walk test, which is a measure of
functional exercise capacity, was
equivocal in both arms. Quality of life
(QOL) was measured using five domains
of the EQ–5D (mobility, self-care, usual
activities, pain/discomfort, and anxiety/
depression) and was found to be
equivocal.
The applicant also conducted
extensive subgroup analyses of the
primary safety end point, efficacy
endpoint, and TLR rates to assess the
response to IN.PACTTM AdmiralTM in
various subpopulations, including:
Rutherford category (2, 3, and 4);
diabetes; age (≥75); lesion length (<5 cm,
≥5 cm to <10 cm, ≥10 cm to <18 cm);
total occlusion, and gender. According
to the applicant, although the trial was
not designed to power the subgroup
analyses, in 9 of these 11 subgroups,
patients in the IN.PACTTM AdmiralTM
treatment group were shown to have
statistically significant better outcomes
than patients in the PTA control group
44 Werk M, Langner S, Reinkensmeier B,
Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm
B, Speck U, Ricke J.: Inhibition of restenosis in
femoropopliteal arteries: paclitaxel-coated versus
uncoated balloon: femoral paclitaxel randomized
pilot trial. Circulation 2008;118: 1358–65.
45 Jones WS, Schmit KM, Vemulapalli S,
Subherwal S, Patel MR, Hasselblad V, Heidenfelder
BL, Chobot MM, Posey R, Wing L, Sanders GD,
Dolor RJ.: Treatment Strategies for Patients With
Peripheral Artery Disease. Comparative
Effectiveness Review No. 118. (Prepared by the
Duke Evidence-based Practice Center under
Contract No. 290–2007–10066–I.) AHRQ
Publication No. 13–EHC090–EF. Rockville, MD:
Agency for Healthcare Research and Quality; May
2013. Available at: https://
www.effectivehealthcare.ahrq.gov/reports/final.
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in the primary effectiveness and safety
endpoints as well as clinically-driven
TLR. This includes subgroups:
Rutherford categories 2 & 3; diabetes;
age (≥75); lesion length ≥5 cm to <10
cm; lesion length ≥10 cm to <18 cm;
total occlusion; and gender (both male
and female). In the two subgroups that
did not meet statistical significance
(Rutherford category 4 and lesion length
<5 cm), data for the primary
effectiveness and safety endpoints as
well as the clinically driven TLR
trended in favor of IN.PACTTM
AdmiralTM.
We are concerned about the clinical
meaningfulness of some of the
endpoints measured by the trials
conducted by the applicant. For
example, there were no changes in
functional measures such as walking
distances. The applicant indicated that
this may be because patients in the
control group had additional procedures
to the point their symptoms were
controlled to the same extent as those of
the drug-coated balloon group. We
believe that this assertion could be
better supported with data. Another
related example is the higher anklebrachial index in the drug-coated
balloon catheter group. While this is
also consistent with an enduring
physiologic effect of the drug-coated
balloon device, we are concerned that
these ABI measurements appear to have
been made by unblinded study
personnel.
We are concerned that the IN.PACTTM
AdmiralTM technology may not be the
optimal treatment for all patients
diagnosed with peripheral arterial
disease. The drug-coated balloon
catheter has been compared only with a
standard balloon, and no other
alternatives, such as stents, surgery, or
intensive exercise therapy. Therefore, it
is unknown whether a drug-coated
balloon strategy would yield the same,
better, or worse outcomes than these
alternatives. We also note that while
there appears to be broader anatomical
applicability, not all of the studies
provided definitively indicate that it is
a clinical improvement over PTA.
We are seeking public comment on
whether LUTONIX® and IN.PACTTM
AdmiralTM meet the substantial clinical
improvement criterion, specifically with
regard to our concerns discussed.
Below we summarize the written
public comments on the LUTONIX® and
IN.PACTTM AdmiralTM technologies that
we received in response to the town hall
meeting.
Comment: One commenter, a major
society on vascular medicine, stated that
without new technology add-on
payments for drug-coated balloon
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catheters, facilities will not be
adequately compensated for procedures
involving these devices and patient
access to these new beneficial
technologies will be hampered. The
commenter believed that the technology
being developed by both manufacturers
meets the newness criterion. The
commenter stated that the drug-coated
balloon catheters represent
advancement in medical technology that
substantially improves, relative to
technologies previously available, the
treatment of Medicare beneficiaries.
Specifically, the commenter stated that
the results of the clinical trials for these
devices have established that these
devices achieve more durable patency
by reducing restenosis, which in turn
reduces the rate of repeat interventions.
The commenter further stated that these
devices do not require a permanent
implant, which preserves future
treatment options. The commenter also
noted documented improvements
treatment results for patients diagnosed
with PAD according to an article in the
JAMA.46 The commenter expressed
support for approval of new technology
add-on payments for both the
LUTONIX® and the IN.PACTTM
AdmiralTM technologies, with hopes of
minimizing any financial barriers that
might prevent patients from having
access to this technology.
Another commenter supported the
approval of new technology add-on
payments for the LUTONIX® and
IN.PACTTM AdmiralTM technologies and
for other drug-coated balloon catheters
in the treatment of patients diagnosed
with SFA in the United States.
Specifically, the commenter stated that
the clinical study results have shown
that using drug-coated balloon catheters
both keep a vessel open for a longer
period of time and reduce the total
number of repeat procedures that may
need to be performed. The commenter
further stated that treatment using
existing therapies in his own practice
have resulted in patients returning for
repeat procedures 1 to 2 times per year.
The commenter noted that the
additional benefit of reducing
revascularization, which allows patients
to remain mobile for longer periods of
time, further reduces potential
complications and hospitalizations.
The commenter also noted that
colleagues outside the United States
have had access to this technology for
over 5 years and the technology’s use
has shown positive results in different
46 Goodney, Tarulli, Faerber, et al. Fifteen-Year
Trends in Lower Limb Amputation,
Revascularization, and Preventive Measures Among
Medicare Patients. JAMA Surg. 2015;150(1):84–86.
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patient and lesion subgroups, which
provides strong evidence that supports
the wide use of drug-coated balloon
catheters. The commenter stated that
there are a number of publications that
advocate that the reduced need for
revascularization also results in
significant cost savings for health care
systems, and recommended that these
additional savings and value to be
shared with hospitals in the United
States. The commenter stated that,
although there is clear clinical evidence
that supports the use of drug-coated
balloon catheters, there are concerns
that hospital administrators may limit
the use of these catheters because of the
added cost burden that would be
completely imposed on hospitals in the
current health care system.
Response: We appreciate the
commenters’ input. We will consider
these comments in our analysis and
final determination of the applications
for new technology add-on payments for
FY 2016.
h. VERASENSETM Knee Balancer
System (VKS)
OrthoSensor submitted an application
for new technology add-on payments for
the VERASENSETM Knee Balancer
System (VKS) for FY 2016. The VKS is
a sterile, single patient use device to
intraoperatively provide a means to
dynamically balance the patient’s knee
during total knee arthroplasty (TKA)
surgery. The applicant maintained that
quantitative metrics, viewed on a
monitor through real time wireless
information, enable the surgeon to
improve soft tissue stability and kinetics
during TKA surgery. The VKS device
includes a tibial trial insert composed of
an array of responsive sensors that
delivers quantified kinetic balance data
during TKA surgery. The quantitative
data provides a basis for the surgeon to
make data-based decisions regarding
tissue dissection during TKA surgeries,
resulting in a more stable outcome.
According to the applicant, the VKS
device combines dual sensor elements,
coupled with micro-processing
technology, to accurately depict intraarticular kinetics and contact point
locations within the knee. The tibial
trial insert is placed in the knee capsule.
Proper placement of the insert does not
require any force or infiltration of the
bone or soft tissue in the knee. The
applicant stated that the VKS device
uses wireless communication protocols
that overcome line-of-sight or other
interference issues, therefore
eliminating the need for line-of-sight or
direct antenna-based tracking during the
TKA surgery.
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The first version of the VKS received
FDA approval in 2009 for the OrthoRex
Intra-Operative Load Sensor. The device
was indicated for use as a tool to adjust
the femoral knee implant to reduce
instability from flexion gap asymmetry
using a single patient use sterile force
sensor. The applicant noted that the first
version of the VKS was not available on
the U.S. market at the time of FDA
approval in 2009. The applicant stated
that the 510K approval from the FDA
allowed permission to continue to test
the device and improve upon the
specificity of the sensors. The applicant
stated that the first version of the VKS
did not enter on the U.S. market until
late 2011. Further advancements were
made to the VKS to more accurately
refine the sensor specificity, which
provides more accurate balance data
unique to the contours of specific knee
implant components. The applicant
further explained that the tibial trial
sensor was redesigned to respond
quantitatively and specifically to the
variations of the contours of specifically
manufactured knee implants. The
advanced sensor specificity, developed
in conjunction with data gained from
clinical trials, provides information
regarding force and balance metrics that
aid the surgeon’s understanding and
measurement of knee balance. The
applicant noted that without the
advancements to the sensor specificity,
which were perfected based on
knowledge gained from the clinical
trials, the sensor would not be as
clinically useful as it is currently. These
advancements resulted in additional
FDA clearances on June 13, 2013, and
October 14, 2013. The product’s
description was updated on January 28,
2014.
The applicant maintained that the
VKS meets the newness criterion. The
applicant analyzed the relative weights
from 2010 to 2014 for the MS–DRGs that
may contain cases that would be eligible
for the advanced VKS technology (MS–
DRGs 461 through 470). The applicant
noted that there was no increase in the
calculation of the FY 2014 or FY 2015
relative weights for these MS–DRGs to
represent the additional cost of the
advanced VKS technology.
We are concerned that the
advancements made to the VKS that
resulted in the additional FDA approval
clearances in 2013 may not be
significant enough to distinguish the
advanced technology from the first
version of the VKS, which received FDA
approval in 2009. We believe that the
advanced VKS may be substantially
similar to the first version of the VKS
(that was first available on the U.S.
market in late 2011) and, therefore,
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would not meet the newness criterion.
In addition, the costs associated with
the VKS should be reflected in the FY
2013 and subsequent relative payment
weights for these MS–DRGs because the
product has been available and used for
the Medicare population since 2011.
In the FY 2010 IPPS/RY 2010 LTCH
PPS final rule (74 FR 43813 through
43814), we established criteria for
evaluating whether a new technology is
substantially similar to an existing
technology, specifically: (1) Whether a
product uses the same or a similar
mechanism of action to achieve a
therapeutic outcome; (2) whether a
product is assigned to the same or a
different MS–DRG; and (3) whether the
new use of the technology involves the
treatment of the same or similar type of
disease and the same or similar patient
population. If a technology meets all
three of the criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
In evaluating the application under
the substantial similarity criteria, we
believe that the first version of the VKS
and the advance version of the VKS use
the same mechanism of action to
achieve the desired outcome by using a
sterile device that is equipped with
sensors used to adjust the femoral knee
implant to reduce instability from
flexion gap asymmetry. In addition, we
believe that cases involving the first
version of the VKS would be assigned
to the same MS–DRG as the cases
involving the advanced VKS. Moreover,
we believe that both the first version of
the VKS and the advanced version of
the VKS treat the same or similar
disease and the same or similar patient
population. Specifically, both of the
VKS technologies are used in the
treatment of patients undergoing TKA
surgery. Because we believe that the
technology meets all three of the
substantial similarity criteria, we
believe that the beginning of the
newness period for this technology
would commence when it became
available on the U.S. market in late
2011. Therefore, the VKS may not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
As discussed in the FY 2005 IPPS
final rule (69 FR 49003), once data
become available to reflect the cost of
the technology in the relative weights,
the technology can no longer be
considered ‘‘new’’ and eligible to
receive new technology add-on
payments. Section 412.87(b)(2) states
that a medical service or technology
may be considered new within 2 or 3
years after the point at which data begin
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to become available reflecting the ICD–
9–CM code assigned to the new service
or technology (depending on when a
new code is assigned and data on the
new service or technology become
available for DRG recalibration).
Further, after CMS has recalibrated the
DRGs, based on available data, to reflect
the costs of an otherwise new medical
service or technology, the medical
service or technology will no longer be
considered ‘‘new’’ under the criterion of
this section. Therefore, we believe that
the costs of this technology are included
in the charge data and the MS–DRGs
have been recalibrated using that data.
Therefore, the technology can no longer
be considered ‘‘new’’ for the purposes of
this provision, regardless of whether or
not there was an increase in the MS–
DRG relative weights during FYs 2014
and 2015, specifically because of the
inclusion of the cost of the technology.
As previously stated, we believe that
the beginning of the newness period for
the VKS commenced when the product
was first made available on the U.S.
market in late 2011. The 3-year
anniversary date of the product’s
availability on the U.S. market occurred
in late 2014, which is prior to the
beginning of FY 2016. Therefore, we do
not believe that the VKS technology can
be considered ‘‘new’’ for purposes of
new technology add-on payments. We
are inviting public comments regarding
whether or not the VKS technology is
substantially similar to existing
technologies, and whether or not the
VKS technology meets the newness
criterion.
Currently, there are no ICD–9–CM or
ICD–10–PCS procedure codes that
uniquely identify the use of this
technology. As stated above, effective
October 1, 2015 (FY 2016), the ICD–10
coding system will be implemented.
The applicant submitted a request for a
unique ICD–10–PCS code that was
presented at the March 18, 2015 ICD–10
Coordination and Maintenance
Committee meeting. If approved, the
code(s) will be effective on October 1,
2015 (FY 2016). More information on
this request can be found on the CMS
Web site located at the following link:
https://www.cms.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
With regard to the cost criterion, the
applicant supplied three analyses to
demonstrate that it meets the cost
criterion. The applicant believed that
cases that are eligible for the VKS
technology map to MS–DRGs 461 and
462 (Bilateral or Multiple Major Joint
Procedures of Lower Extremity with
MCC and without MCC, respectively),
MS–DRGs 466 through 468 (Revision of
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Hip or Knee replacement with MCC,
with CC, and without CC/MCC,
respectively), and MS–DRGs 469 and
470 (Major Joint Replacement or
Reattachment of Lower Extremity with
MCC and without MCC, respectively).
The first analysis used data from the
2012 National Inpatient Sample (NIS)
from the Agency for Research and
Quality (AHRQ). We note that the NIS
includes Medicare, Medicaid, and
commercial and uninsured claims data.
However, the applicant limited its
search to Medicare cases only.
The applicant searched for all
Medicare cases assigned to MS–DRGs
461 and 462 and found 812 and 14,200
cases respectively (for a total of 15,012
cases). The applicant noted that the
15,012 cases assigned to MS–DRGs 461
and 462 also include cases representing
hip revision procedures. Therefore, to
determine the number of eligible cases
reporting bilateral knee revisions
assigned to MS–DRGs 461 and 462,
based on clinical information,47 the
applicant approximated that 4 percent
of the cases assigned to MS–DRGs 461
and 462 represent Medicare
beneficiaries who may be eligible for the
VKS for a bilateral knee revision
procedure. As a result, the applicant
focused its analysis on 32 cases assigned
to MS–DRG 461 (812 cases * .04), and
568 cases assigned to MS–DRG 462
(14,200 cases * .04). We are concerned
that the statistical data obtained from
clinical information that the applicant
used to determine the percentage of
cases representing bilateral knee
revisions still includes cases
representing hip revision procedures.
Specifically, the applicant did not
uniquely identify cases representing
bilateral knee revisions and only
produced a percentage of all cases that
still includes cases for hip revision
procedures.
According to the applicant, eligible
cases for the VKS technology include
cases representing knee revision
procedures that also map to MS–DRGs
466 through 468 (which represent
degrees of severity calculated for each
MS–DRG). To determine the number of
eligible cases reporting knee revision
procedures assigned to MS–DRGs 466
through 468, the applicant first searched
the NIS database for the total number of
Medicare cases assigned to these MS–
DRGs. This resulted in a total of 54,105
cases. The applicant noted that MS–
DRGs 466 through 468 also include
cases for hip and knee revision
47 Memtsoudis SG, Valle AGD, Besculides MC,
Gaber, Sculco TP.: In-hospital complications and
mortality of unilateral, bilateral, and revision TKA.
2008, Clin Orthop Relat Res, 466:2617–2627.
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procedures. Therefore, to determine the
number of cases representing knee
revision procedures in each of these
three MS–DRGs, the applicant first
divided the number of Medicare cases
for each MS–DRG (5,195 for MS–DRG
466, 28,650 for MS–DRG 467, and
20,260 for MS–DRG 468) by the total
number of Medicare cases assigned to
MS–DRGs 466, 467, and 468 (54,105).
The applicant then multiplied the
percentage for each MS–DRG (9.6
percent for MS–DRG 466, 52.9 percent
for MS–DRG 467, and 37.4 percent for
MS–DRG 468) by the total amount of
cases assigned to each MS–DRG. Based
on this calculation, the applicant
approximated the following number of
cases representing knee revision
procedures assigned to each of these
three MS–DRGs: 3,054 cases in MS–
DRG 466; 16,842 in MS–DRG 467; and
11,910 in MS–DRG 468. We are
concerned that the methodology the
applicant used to determine the
percentage of cases representing knee
revision procedures still includes cases
representing hip revision procedures.
Specifically, in its methodology, the
applicant did not use any source of
statistical relevance to isolate cases
representing knee revision procedures.
Rather, the applicant used the
percentage of Medicare cases assigned
to each MS–DRG of the overall total
cases for the three MS–DRGs, which
includes knee and hip revisions, and
multiplied by this percentage to further
reduce the total number of cases. We do
not believe that this further reduction to
the total number of Medicare cases has
sufficiently isolated cases representing
knee revision procedures.
According to the applicant, eligible
cases for the VKS technology also
include TKA procedures that map to
MS–DRGs 469 and 470. To determine
the number of eligible cases reporting
TKA procedures assigned to MS–DRGs
469 and 470, the applicant first searched
the NIS database for the total number of
Medicare cases assigned to these MS–
DRGs. This resulted in 35,740 cases in
MS–DRG 469 and 547,955 cases in MS–
DRG 470. The applicant noted that MS–
DRGs 469 and 470 also include cases
representing hip replacement and other
joint replacement procedures.
Therefore, in order to determine the
number of TKA procedures within these
MS–DRGs, the applicant searched the
NIS database for cases reporting ICD–9–
CM procedure codes that typically map
to these MS–DRGs. The applicant first
searched for cases representing TKA
across all MS–DRGs that reported ICD–
9–CM procedure code 81.54 (Total knee
replacement) and found 336,050 cases.
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The applicant then searched the NIS
database for cases representing hip and
other joint replacement procedures
across all MS–DRGs that reported ICD–
9–CM procedure codes 81.51 (Total hip
replacement), 81.52 (Partial hip
replacement), 81.56 (Total ankle
replacement), 81.57 (Replacement of
joint of foot and toe), and 81.59
(Revision of joint replacement of lower
extremity, not elsewhere classified) and
found 238,050 cases. This resulted in a
total of 574,100 cases representing knee,
hip, and other joint replacement
procedures.
The applicant then divided the
number of cases representing TKA
procedures by the total number of cases
(336,050/574,100) and determined that
58.5 percent of all cases assigned to
MS–DRGs 469 and 470 are related to
TKA procedures. The applicant then
multiplied the percent of cases
representing TKA procedures (58.5
percent) by the number of cases
assigned to MS–DRGs 469 and 470,
which resulted in 20,920 cases in MS–
DRG 469 (35,740 * .585) and 320,746
cases in MS–DRG 470 (547,955 * .585).
We are concerned that the methodology
the applicant used to determine the
percentage of cases representing TKA
procedures still includes cases
representing hip and other joint
replacement procedures. Specifically,
the applicant did not uniquely identify
cases representing TKA procedures and
only produced a percentage of all cases,
which still includes cases representing
hip and other joint replacement
procedures.
Based on the analysis above, the
applicant maintained that the total
number of cases across MS–DRGs 461
and 462 and MS–DRGs 466 through 470
was 374,071. The applicant determined
an average case-weighted charge per
case of $57,341. The applicant then
determined that it was necessary to
remove charges related to the other
computer-assisted devices/technologies
used during these procedures and
charges for operating room time because
procedures involving the VKS do not
require operating room time, and the
charges for the VKS technology would
inevitably be different. Therefore, the
applicant removed approximately $146
from the average case-weighted charge
per care for cases assigned to MS–DRGs
461 and 462, and $73 from the average
case-weighted charge per case for cases
assigned to MS–DRGs 466 through 470.
The applicant noted that the $146 in
charges removed from the average caseweighted charges per case for cases
assigned to MS–DRGs 461 and 462 was
slightly higher than the charges
removed from cases assigned to MS–
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DRGs 466 through 470 because these
charges were for bilateral procedures
which require additional operating
room time.
Data from the NIS database is only
available on a national level and not on
a hospital-specific level. Therefore, in
order to standardize the charges per
case, the applicant used the FY 2012
IPPS Impact File and the mean value of
all relevant standardization factors to
standardize the charges per case. We are
concerned that the analysis provided by
the applicant did not use hospitalspecific data and, therefore, the
standardization process may be
inaccurate because of the use of mean
factors rather than hospital-specific
factors. By using mean factors rather
than hospital-specific factors, we
believe that the standardization
performed by the applicant does not
sufficiently take into account hospital
variations.
The applicant then inflated the
charges using an inflation factor of
10.4227 percent based on the inflation
factor in the FY 2015 IPPS/LTCH PPS
final rule (79 FR 50379), and added the
charges related to the VKS technology to
the adjusted average case-weighted
standardized charge per case. This
resulted in a final inflated average caseweighted standardized charge per case
of $68,121. Using the FY 2015 IPPS
Table 10 thresholds, the applicant
determined that average case-weighted
threshold amount for MS–DRGs 461 and
462 and MS–DRGs 466 through 470 is
$57,341. Because the final inflated
average case-weighted standardized
charge per case for the applicable MS–
DRGs exceeds the average case-weighted
threshold amount, the applicant
maintained that the technology meets
the cost criterion.
The applicant’s second analysis used
data from the 2013 American Hospital
Discharge Data (AHD) based on 57
randomly selected hospitals. The
applicant searched the data and did not
find any cases assigned to MS–DRG 461.
The applicant noted that it used a value
of 10 cases for its analysis of cases
assigned to MS–DRG 461 because data
reflecting a zero value indicates that the
hospital performed less than 10
procedures. The applicant found 533
cases assigned to MS–DRG 462. To
determine the number of cases
representing bilateral knee revision
procedures in MS–DRG 462, similar to
the first analysis, the applicant
multiplied the total number of cases
assigned to MS–DRG 462 by 4 percent,
which resulted in 21 cases. Similar to
our statement about the first analysis,
we are concerned that the applicant did
not uniquely identify cases representing
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bilateral knee revision procedures and
only produced a percentage of all cases,
which still includes cases representing
hip revision procedures.
To determine the number of eligible
cases reporting knee revision
procedures assigned to MS–DRGs 466
through 468, the applicant first searched
the AHD database for the total number
of cases assigned to these MS–DRGs.
This resulted in a total of 2,969 cases.
Because these MS–DRGs include cases
representing hip and knee revision
procedures, to determine the number of
cases representing knee revision
procedures in each of these three MS–
DRGs, the applicant first divided the
number of cases for each MS–DRG (122
for MS–DRG 466; 1,746 for MS–DRG
467; and 1,101 for MS–DRG 468) by the
total number of cases in MS–DRGs 466
through 468 (2,969). The applicant then
multiplied the percentage for each MS–
DRG (4.1 percent for MS–DRG 466; 58.8
percent for MS–DRG 467; and 37.1
percent for MS–DRG 468) by the total
number of cases in each MS–DRG.
Based on this calculation, the applicant
approximated the following number of
cases representing knee revision
procedures in each of these three MS–
DRGs: 1,307 cases in MS–DRG 466;
18,704 in MS–DRG 467; and 11,794 in
MS–DRG 468. Similar to our concerns
about the first analysis, we are
concerned that the methodology the
applicant used to determine the
percentage of cases of knee revision
procedures still includes cases
representing hip revision procedures.
Specifically, in its methodology, the
applicant did not use any source of
statistical relevance to isolate cases
representing knee revision procedures.
The applicant simply used the
percentage of Medicare cases for each
MS–DRG of the overall total cases for
the three MS–DRGs, which include knee
and hip revision procedures, and
multiplied by this percentage to further
reduce the number of cases. We do not
believe that this further reduction to the
total number of Medicare cases has
isolated cases representing knee
revision procedures.
The applicant used the same
methodology from the first analysis to
determine the number of eligible cases
representing TKA procedures assigned
to MS–DRGs 469 and 470. The applicant
searched the AHD database and found
1,217 cases assigned to MS–DRG 469
and 24,620 cases assigned to MS–DRG
470. To determine the number of cases
representing TKA procedures within
these MS–DRGs, the applicant
multiplied the total number of cases
within these MS–DRGs by the
percentage of 58.5 percent from the NIS
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database, which represents the
percentage of knee replacement
procedure cases among the total number
of cases representing knee, hip and joint
replacement procedures. This resulted
in 712 cases in MS–DRG 469 (1,217 *
.585) and 14,411 cases in MS–DRG 470
(24,620 * .585). Similar to our concerns
expressed earlier, we are concerned that
the methodology the applicant used to
determine the percentage of cases
representing TKA procedures still
includes cases representing hip
replacement and other joint replacement
procedures. Specifically, the applicant
did not uniquely identify cases
representing TKA procedures and only
produced a percentage of all cases,
which still includes cases representing
hip and other joint replacement
procedures.
Based on this analysis, the applicant
maintained that the total number of
cases across MS–DRGs 461 and 462 and
MS–DRGs 466 and 470 was 46,960. The
applicant determined an average caseweighted charge per case of $80,702. For
the rest of the analysis, the applicant
followed the same methodology as the
first analysis. The applicant removed
$146 from the average case-weighed
charge per case for cases assigned to
MS–DRGs 461 and 462 and $73 from the
average case-weighted charge per case
for cases assigned to MS–DRGs 466
through 470 for charges related to other
computer-assisted devices/technologies
used during these procedures and
additional charges for the use of the
operating room.
Similar to the first analysis, the
applicant used the FY 2012 IPPS impact
file and the mean value of all relevant
standardization factors from all
hospitals to standardize the charges per
case. Similar to above, we are concerned
that the analysis provided by the
applicant did not use hospital-specific
data and, therefore, the standardization
process may be inaccurate because of
the use of mean factors rather than
hospital-specific factors. By using mean
factors rather than hospital-specific
factors, the standardization performed
by the applicant does not sufficiently
take into account hospital variations.
The applicant then inflated the
charges using an inflation factor of
10.4227 percent based on the inflation
factor in the FY 2015 IPPS/LTCH PPS
final rule (79 FR 50379), and added the
charges related to the VKS technology to
the adjusted average case-weighted
standardized charge per case. This
resulted in a final inflated average caseweighted standardized charge per case
of $90,515. Using the FY 2015 IPPS
Table 10 thresholds, the applicant
determined that the average case-
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weighted threshold amount for MS–
DRGs 461 and 462 and MS–DRGs 466
through 470 is $80,699. Because the
final inflated average case-weighted
standardized charge per case exceeded
the average case-weighted threshold
amount for the applicable MS–DRGs,
the applicant maintained that the VKS
technology meets the cost criterion.
The applicant’s third analysis used
data from the FY 2015 CMS Before
Outliers Removed (BOR) file. The BOR
file contained 469 cases in MS–DRG 461
and 9,396 cases in MS–DRG 462. To
determine the number of cases
representing bilateral knee revision
procedures assigned to MS–DRGs 461
and 462, similar to the first analysis, the
applicant used an assumption of 4
percent, which resulted in 19 cases in
MS–DRG 461 and 376 cases in MS–DRG
462. Similar to our concerns stated
earlier, we are concerned that the
applicant did not uniquely identify
cases representing bilateral knee
revision procedures and only produced
a percentage of all cases, which still
includes cases representing hip revision
procedures.
To determine the number of eligible
cases reporting knee revision
procedures assigned to MS–DRGs 466
through 468, the applicant again
analyzed the BOR file which contained
a total of 44,420 cases. Similar to first
two analyses, because these MS–DRGs
include cases representing hip and knee
revision procedures, to determine the
number of cases representing knee
revision procedures in each of these
three MS–DRGs, the applicant first
divided the number of cases for each
MS–DRG (4,202 for MS–DRG 466;
23,390 for MS–DRG 467; and 16,828 for
MS–DRG 468) by the total number of
cases in MS–DRGs 466 through 468
(44,420). The applicant then multiplied
the percentage for each MS–DRG (9.5
percent for MS–DRG 466; 52.7 percent
for MS–DRG 467; and 37.9 percent for
MS–DRG 468) by the total number of
cases in each MS–DRG. Based on this
calculation, the applicant approximated
the following number of cases
representing knee revision procedures
in each of these three MS–DRGs: 3,009
cases in MS–DRG 466; 16,747 in MS–
DRG 467; and 12,049 in MS–DRG 468.
Similar to our concerns stated earlier,
we are concerned that the methodology
the applicant used to determine the
percentage of cases representing knee
revision procedures still includes cases
representing hip revision procedures.
Specifically, in its methodology, the
applicant did not use any source of
statistical relevance to isolate cases
representing knee revision procedures.
Rather, the applicant used the
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percentage of Medicare cases for each
MS–DRG of the overall total number of
cases for the three MS–DRGs, which
includes cases representing knee and
hip revision procedures, and multiplied
by this percentage to further reduce the
number of cases. We do not believe that
this further reduction to the total
number of Medicare cases has isolated
cases representing knee revision
procedures.
The applicant used the same
methodology from the first analysis to
determine the number of eligible cases
reporting TKA procedures assigned to
MS–DRGs 469 and 470. The BOR file
contained 27,737 cases in MS–DRG 469
and 437,649 cases in MS–DRG 470. To
determine the number of cases
representing TKA procedures within
these MS–DRGs, the applicant
multiplied the total number of cases
within these MS–DRGs by the
percentage of 58.5 percent obtained
from the NIS database, which represents
the percentage of knee replacement
cases among the total number of cases
representing knee, hip, and joint
replacement procedures. This resulted
in 16,236 cases in MS–DRG 469 (27,737
* .585) and 256,178 cases in MS–DRG
470 (437,649 * .585). Similar to our
concerns stated earlier, we are
concerned that the methodology the
applicant used to determine the
percentage of cases representing TKA
procedures still includes cases
representing hip and other joint
replacement procedures. Specifically,
the applicant did not uniquely identify
cases representing TKA procedures and
only produced a percentage of all cases,
which still includes cases representing
hip and other joint revision procedures.
Based on this analysis, the applicant
maintained that the total number of
cases across MS–DRGs 461 and 462 and
MS–DRGs 466 through 470 was 304,614.
The applicant determined an average
case-weighted charge per case of
$56,282. For the rest of the analysis, the
applicant followed the same
methodology as the first analysis. The
applicant then removed $146 from the
average case-weighted charge per case
for cases assigned to MS–DRGs 461 and
462 and $73 from the average caseweighted charge per case for cases
assigned to MS–DRGs 466–470 for
charges related to other computerassisted devices/technologies used
during these procedures and additional
charges for the use of the operating
room.
Similar to the first analysis, the
applicant used the FY 2012 IPPS Impact
File and the mean value of all relevant
standardization factors from all
hospitals to standardize the charges per
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case. Similar to our concerns stated
earlier, we are concerned that the
analysis provided by the applicant did
not use hospital-specific data and,
therefore, the standardization process
may be inaccurate because of the use of
mean factors rather than hospitalspecific factors. By using mean factors
rather than hospital-specific factors, we
believe that the standardization
performed by the applicant does not
sufficiently take into account hospital
variations.
The applicant then inflated the
charges using an inflation factor of
10.4227 percent based on the inflation
factor in the FY 2015 IPPS/LTCH PPS
final rule (79 FR 50379), and added the
charges related to the VKS technology to
the adjusted average case-weighted
standardized charge per case. This
resulted in a final inflated average caseweighted standardized charge per case
of $66,382. Using the FY 2015 IPPS
Table 10 thresholds, the applicant
determined that the average caseweighted threshold amount for MS–
DRGs 461 and 462 and MS–DRGs 466
through 470 is $64,280. Because the
final inflated average case-weighted
standardized charge per case exceeds
the average case-weighted threshold
amount for the applicable MS–DRGs,
the applicant maintained that the VKS
technology meets the cost criterion.
Based on the information provided by
the applicant, combined with the weight
of our concerns, we are unable to
determine if and how the VKS
technology meets the cost criterion. We
are inviting public comments on
whether or not the VKS technology
meets the cost criterion, specifically
with regard to the concerns raised.
With regard to substantial clinical
improvement, the applicant maintained
that the VKS technology represents a
substantial clinical improvement. The
applicant stated that the device offers a
treatment option for a patient
population unresponsive to, or
ineligible for, currently available
treatments. The applicant explained that
the use of the VKS technology has
improved patient outcomes, including
rapid recovery of patients diagnosed
with comorbidities, the early return to
normal activities, and increased levels
of activity and functionality. The
applicant noted that patients treated
using the VKS technology during TKA
procedures did not experience
readmission within 30 days, nor was it
necessary for the treating physician (the
surgeon) to complete a problem focused
medical evaluation during the patient’s
recovery. The applicant further noted
that patients having a more favorable
immediate outcome with a stable TKA
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were shown to return to normal
function more rapidly than patients
with unbalanced knees. Therefore, the
applicant stated that patients with
complex medical conditions would be
able to respond to the early return of
normal daily living.
The applicant also believed that the
device offers the ability to diagnose a
medical condition for a patient
population experiencing medical
conditions that are currently
undetectable, or offers the ability to
diagnose a medical condition earlier
than that which is capable using
currently available technologies. The
applicant explained that the VKS
technology provides an improved
evaluation/diagnosis compared to an
unbalanced TKA implant. Specifically,
the applicant stated that the device
enables the surgeon to obtain
intraoperative measures enabling the
surgeon to improve upon the placement
of the TKA tibial and femoral
components. Additionally,
intraoperatively the device leads to an
immediate diagnosis of an implant that
can now be accurately positioned due to
informed fine tissue dissection. The
applicant stated that the intraoperative
technique has been demonstrated to
result in increased implant stability and
functional congruence. The applicant
cited the following examples of
outcomes that have been frequently
documented and evaluated within
clinical studies of medical devices:
• Intended to address the leading
causes of early implant failure in TKA:
Instability, malrotation and
malalignment;48
• Dynamic intercompartmental load
data and Kinetic Tracking enables
evidence based soft tissue releases to
improve stability through full ROM;49
• Provides intraoperative feedback on
tibial–femoral component rotation,
position of femoral Contact Points and
femoral roll-back to facilitate optimal
component position
• Enables reproducible, teachable
surgical technique through quantifying
surgeon ‘‘feel’’; and
• Captures intraoperative data for
inclusion in patient EMR, registries or
comparative effectiveness studies.
The applicant stated that use of the
device significantly improves clinical
outcomes for a patient population
experiencing these types of medical
procedures when compared to currently
available treatments. The applicant
48 Rodriguez-Merchan EC.: Instability Following
Total Knee Arthroplasty. HSSJ 2011; 7:273–278.
49 Roche MW, Elson LC, Anderson CR.: A Novel
Technique Using Sensor-Based Technology to
Evaluate Tibial Tray Rotation. Orthopedics. 2014
(In Press).
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explained that extensive research and
development has resulted in the VKS
technology demonstrating improved
patient outcomes in multi-center
studies. The applicant further explained
that the VKS technology has
intraoperatively provided a unique
opportunity to observe the short-term
clinical outcomes of patients with a
quantifiably balanced knee versus those
who have quantifiably unbalanced
knees. According to the applicant, in a
multi-center study, the use of the VKS
technology has been shown to reduce
post-operative pain and improve
activity and patient satisfaction scores
with statistical significance.
Additionally, the applicant stated that
97 percent of patients whose knees were
balanced using the VKS technology
reported that they were ‘‘satisfied’’ to
‘‘very satisfied’’ at 1-year post-operative
compared to 81 percent patient
satisfaction after a TKA procedure
without the use of the VKS technology.
The applicant stated that the VKS
technology provided a 16-percent
improvement in patient satisfaction for
balanced knees; the first significantly
notable increase of patient-reported
satisfaction in over 30 years.50
According to the applicant, the use of
the VKS technology avoided early
implant failure. The applicant explained
that considering the objective to
ameliorate the present risks of revision
in TKA procedures, the VKS technology
has been advanced to address the need
for improved knee balance through fine
tissue dissection using information from
the VKS technology intelligent tibial
trial. While not disturbing the surgical
flow of TKA procedures, the applicant
stated that the VKS technology provides
the surgeon with data on the dynamic
intercompartmental load, and kinetic
tracking enables evidence-based soft
tissue releases to improve stability
through full ROM.51 The applicant
noted that the results of multi-center
studies, using the VKS technology
intraoperatively, have provided an
opportunity to observe the short-term
clinical outcomes of patients with a
quantifiably balanced knee versus those
who have quantifiably unbalanced
knees.
The applicant further stated that the
VKS technology provides intraoperative
information on tibial–femoral
component rotation, position of femoral
50 Gustke KA, et al.: Increased satisfaction after
total knee replacement using sensor-guided
technology. Bone Joint J 2014;96–B:1333–8.
51 Gustke, Golladay, et al.: A New Method for
Defining Balance: Promising Short-Term Clinical
Outcomes of Sensor-Guided TKA. The Journal of
Arthroplasty 25 November 2013 (Article in Press
DOI: 10.1016/j.arth.2013.10.020)
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contact points and femoral roll-back to
facilitate optimal component position.
One clinical study 52 reported 170
primary TKA procedures where the VKS
technology corrected what would have
resulted in unbalanced and malrotated
implants in 53 percent of the patients.
The applicant noted that when
referencing the tibial tubercle to
maximize tibiofemoral congruency, 53
percent of patients exhibited
asymmetrical tibiofemoral congruency
in extension. The applicant further
stated that of those patients, 68 percent
were shown to have excessive internal
rotation of the tibial tray relative to the
femur, while 32 percent exhibited
excessive external rotation.
Additionally, the average tibiofemoral
incongruency deviated from a neutral
position by 6°, ranging from 0.5° to 19.2.
The applicant stated that when
comparing the VKS with the convention
of using the tibial tubercle to maximize
tibiofemoral congruency to confirm the
final rotation of the tibial tray, the VKS
technology provided superior
information. The applicant added that
data from using the tibial tubercle to
maximize tibiofemoral congruency to
confirm the final rotation of the tibial
tray are highly variable and inconsistent
for confirming the final rotation of the
tibial tray.
The applicant stated that the VKS
technology has demonstrated and
resulted in a ‘‘balanced knee’’ after TKA
procedures with 6 month and 1 year
outcome scores showing a significant
improvement over conventional or
computer-assisted TKA procedures.
According to the applicant, by not
disrupting the surgical flow the VKS
technology has been viewed by surgeons
to provide information enabling them to
improve upon the balance of the knee,
reduce the degree of rotation and only
dissect the fine tissue as needed sparing
the release of the ligaments. The
applicant further stated that the VKS
technology has been shown to enable
reproducible, teachable surgical
technique through quantifying surgeon
‘‘feel.’’
The applicant provided patient
outcomes at 6 months and believed that
this demonstrated a significant
improvement for the ‘‘balanced knee’’
TKA procedures using the VKS
technology. According to the applicant,
multivariate binary logistic regression
analyses were performed for both Knee
Society Scores (KSS) and Western
Ontario and McMaster Universities
52 Roche MW, Elson LC, Anderson CR: A Novel
Technique Using Sensor-Based Technology to
Evaluate Tibial Tray Rotation. Orthopedics. 2015
(In Press)
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Arthritis Index (WOMAC) scores at 6
months. Variables run in these analyses
included: age at surgery, BMI, gender,
preoperative ROM, preoperative
alignment, change in activity level
(preoperative to 6 months), and joint
state (balanced versus unbalanced). For
KSS and WOMAC, both step-wise and
backward multivariate logistic
regression analyses were calculated to
be best fit models with similar
significance (P = 0.001). Ultimately, the
step-wise model was used. The
applicant stated that the binary model
revealed that the variable exhibiting the
most significant effect of improvement
on KSS and WOMAC scores was
balanced joint state (P = 0.001; P =
0.004). The applicant noted that joint
state was the most highly significant
variable; this demonstrated similar
levels of significance throughout all
possible combinations of variables
included in the model (P = 0.001). The
applicant added that joint state was also
observed to be the sole significant factor
in patient-reported outcome score
improvement (P b 0.001).
The applicant added that analysis of
the data revealed there was also a
concurrent significance observed with
activity level (P = 0.005). However, the
applicant noted that activity level was
not significant on its own. The applicant
concluded that a balanced joint state
results in a higher activity level,53
which would make activity level more
of a dependent variable, rather than a
predictor. Therefore, to demonstrate
activity level, the applicant used a
regression analysis and evaluated KSS
and WOMAC scores at 6 months, with
odds ratios. According to the applicant,
odds ratios were calculated based on
meaningful clinical improvement in
KSS scores, WOMAC scores, and
activity levels at 6 months.
Additionally, based on literature review,
‘‘meaningful improvement’’ for KSS
scores were anything greater than 50
points; WOMAC scores greater than 30
points; and gains in activity level greater
than or equal two 2 lifestyle levels (from
lowest score to highest: sedentary,
semisedentary, light labor, moderate
labor, heavy labor). Also, scores from
the unbalanced group were used as the
reference point. The applicant stated
that odds ratio for balanced joint state
and improved KSS score was 2.5, with
a positive coefficient (95 percent CI).
The applicant believed that this
suggested a high probability of obtaining
53 Gustke, Golladay, et al.: A New Method for
Defining Balance: Promising Short-Term Clinical
Outcomes of Sensor-Guided TKA. The Journal of
Arthroplasty 25 November 2013 (Article in Press
DOI: 10.1016/j.arth.2013.10.020).
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a meaningful improvement in KSS with
a balanced knee joint, over those who
do not have a balanced knee. According
to the applicant, the odds ratio for
balanced joint state and improved
WOMAC score was 1.3, with a positive
coefficient (95 percent CI). The
applicant believed that this suggested a
favorable probability that patients with
a balanced joint state will achieve a
meaningful improvement in WOMAC
score, over those that do not have a
balanced knee. According to the
applicant, the odds ratio for balanced
joint state and improved activity level
was 1.8, with a positive coefficient (95
percent CI). The applicant believed that
this also suggested a favorable
probability of meaningful gains in
activity level in those with a balanced
knee, versus those with an unbalanced
knee.
The applicant further stated that 1
year clinical trial evidence supports the
VKS technology protocol for TKA
procedures. According to the applicant,
of the 135 patients undergoing sensorguided surgery, 13 percent remained
unbalanced (by surgeon discretion). The
applicant stated that ‘‘surgeon
discretion,’’ in this analysis, indicates
that the surgeon recognized and
accepted the ‘‘unbalanced’’
intercompartmental load difference as
presented by the VKS technology, but
felt that the knee was in a clinically
acceptable state. Pre-operatively, there
was no statistical difference in any
outcomes measures between the two
cohorts, the averages of which were:
total KSS = 105 ± 24.6; total WOMAC
= 47 ± 14.8.
Additionally, according to the
applicant, at 1 year, the average total
KSS score of balanced patients exceeded
that of unbalanced patients by 23.3
points (P <0.001); 179 ± 17.2 and 156 ±
23.4 for the balanced and unbalanced
cohort, respectively. The balanced
cohort average score for KSS pain and
function, separately, were 96.4 and 82.4
respectively; the unbalanced cohort
scored 87.8 and 68.3 points for pain and
function. The applicant stated that the
disparities between the balanced and
unbalanced patients’ pain and function
scores were also highly statistically
significant (P <0.001, P=0.022).
For WOMAC, the applicant noted that
that the balanced cohort improved their
score by 8 points; 10 ± 11.8 and 18 ± 17
for balanced and unbalanced patients,
respectively (WOMAC is scored with an
inverse scale; lower scores indicate
more improvement). The applicant
further stated that while this difference
did not prove to be statistically
significant by the standards set forth for
this analysis (P = 0.085), the authors
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believed that this is due, in part, to the
large standard deviations associated
with both cohorts.
According to the applicant, the
balanced cohort’s average activity level
score was 48.6, which corresponds with
the light to moderate labor categories
(tennis, light jogging, heavy yard work)
and the unbalanced patient’s average
activity level score was 26.7, which
corresponds to the upper limits of the
semi-sedentary range (light housework,
walking for limited distances). The
applicant believed that the difference
between the average scores was
statistically significant (P = 0.015). The
applicant noted that the most notable
aspect of every outcome measure
collected is that the unbalanced patient
scores at 1 year still failed to achieve the
level of improvement of the balanced
patient scores at 6 months.
We have a number of concerns
regarding the applicant’s assertions
regarding substantial clinical
improvement. First, we are concerned
that during the trials, after using the
device surgeons continued to make
manual adjustments to the spacers to set
the knee replacement. The applicant
maintained that the VKS technology
presents better accuracy for the surgeon
when making adjustments to the spacers
when implanting a knee replacement.
However, we are concerned that the
evidence does not delineate the degree
of any improved outcomes or patient
satisfaction associated with use of the
VKS technology versus additional
manual adjustments made by the
surgeon. We also are concerned that
most of the clinical evidence is based on
patient satisfaction surveys. While the
survey data appeared to demonstrate
that patient satisfaction improved, we
do not believe that the data presented is
sufficient to determine if the VKS
technology represents a substantial
clinical improvement over manual
adjustment. Furthermore, the use of
historical literature controls might be
useful during early clinical
development, but there are possible
biases and limitations of this research
design. Specifically, there could be
multiple differences in the preprocedure clinical characteristics of
patients with ‘‘unbalanced’’ knees and
those with ‘‘balanced’’ knees that could
affect outcomes, such as more severe
initial disease, more pre-operative
misalignment, more obesity, or more
comorbidity. These and other potential
confounders were not documented or
adjusted for in the analyses of outcomes
in the literature provided by the
applicant. Additionally, as discussed
above, the applicant released a first
version of the VKS technology in 2011
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and advancements were made to the
VKS technology that resulted in
additional FDA clearances in 2013. The
applicant stated in its application that
the first version is considered the first
technology of its kind and, therefore, we
believe that the VKS technology may no
longer be considered new. The
applicant submitted an application for
the advanced version of the VKS
technology from 2013. However, the
applicant did not present clinical data
to distinguish the improvements made
to the advanced version from the first
version. Therefore, we are unable to
determine if the advanced version
represents a substantial clinical
improvement over existing technologies
(that is, the first version of the VKS
technology). We are inviting public
comments on whether the VKS
technology meets the substantial
clinical improvement criterion,
specifically with regard to our concerns.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
i. WATCHMAN® Left Atrial Appendage
(LAA) Closure Technology
Boston Scientific Corporation
submitted an application for new
technology add-on payments for FY
2016 for the WATCHMAN® Left Atrial
Appendage (LAA) Closure Technology
(WATCHMAN® System). (We note that,
as discussed in detail later in this
section, the applicant submitted an
application for new technology add-on
payments for FY 2015 for the
WATCHMAN® System, but withdrew
its application after we issued the FY
2015 IPPS/LTCH PPS proposed rule.)
According to the applicant, when a
patient has been diagnosed with atrial
fibrillation (AF), the left atrium does not
expand and contract normally. As a
result, the left atrium is not capable of
completely emptying itself of blood.
Blood may pool, particularly in the part
of the left atrium called the left atrial
appendage. This pooled blood is prone
to clotting, causing formation of a
thrombus. If a thrombus breaks off, it is
called an embolism (or
thromboembolism). An embolism can
cause a stroke or other peripheral
arterial blockage.
The applicant asserted that the
WATCHMAN® System device is an
implant that acts as a physical barrier,
sealing the LAA to prevent
thromboemboli from entering into the
arterial circulation from the LAA,
thereby reducing the risk of stroke and
potentially eliminating the need for
Warfarin therapy for patients diagnosed
with nonvalvular AF who are eligible
for Warfarin therapy but for whom the
risks of long-term oral anticoagulation
outweigh the benefits.
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With regard to newness criterion, the
applicant anticipated FDA premarket
approval of the WATCHMAN® System
in the first half of 2015. According to
the applicant, the WATCHMAN®
System is the first LAA closure device
that would be approved by the FDA.
Therefore, the applicant believed that
the technology meets the newness
criterion. Effective October 1, 2004 (FY
2005), ICD–9–CM procedure code 37.90
(Insertion of left atrial appendage
device) was created to identify and
describe procedures using the
WATCHMAN® Left Atrial Appendage
(LAA) Closure Technology. As stated in
section II.G.1.a. of the preamble of this
proposed rule, effective October 1, 2015
(FY 2016), the ICD–10 coding system
will be implemented. Under the ICD–
10–PCS, procedure code 02L73DK
(Occlusion of left atrial appendage with
intraluminal device, percutaneous
approach) is the comparable translation
for ICD–9–CM procedure code 37.90.
We are inviting public comments on
if, and how, the WATCHMAN® System
meets the newness criterion.
With regard to the cost criterion, the
applicant used the FY 2013 MedPAR
file (which contained inpatient hospital
claims data for discharges from October
1, 2012 to September 30, 2013) to search
for cases reporting ICD–9–CM procedure
code 37.90. The applicant provided two
analyses. The first analysis includes all
claims that reported ICD–9–CM
procedure code 37.90, regardless of
whether the code indicated a principal
procedure that determined the MS–DRG
assignment of the case. This analysis
identified 507 cases across 29 MS–
DRGs. The applicant noted that the
MedPAR file contained claims that were
returned to the provider that reported
charges for actual cases from clinical
trials that used the WATCHMAN®
System that were well below post-FDA
approval pricing. Therefore, the
applicant removed the premarket device
related charges. The applicant then
standardized the charges, applied an
inflation factor of 1.10443 based on the
2-year charge inflation factor listed in
the FY 2015 IPPS/LTCH PPS final rule
(79 FR 50379) and then added post-FDA
approval charges for the WATCHMAN®
System. Using the anticipated cost of
the device after FDA approval and the
National Average Implantable Device
cost center CCR, the applicant estimated
device charges post-FDA approval,
combined those with the inflated
average case-weighted standardized
charges per case, and determined a final
inflated average case-weighted
standardized charge per case of
$150,213. The average case-weighted
threshold amount in the FY 2015 IPPS
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Table 10 for these MS–DRGs was
$97,505. Because the final inflated
average case-weighted standardized
charge per case exceeds the average
case-weighted threshold amount of
$97,505, the applicant maintained that
the WATCHMAN® System meets the
cost criterion using this analysis. We are
inviting public comments on the
whether the WATCHMAN® System
meets the cost criterion based on this
analysis.
In the applicant’s second analysis,
cases eligible for the WATCHMAN®
System were identified by claims
reporting ICD–9–CM procedure code
37.90 assigned to MS–DRGs 250 and
251 (Percutaneous Cardiovascular
Procedures without Coronary Artery
Stent with MCC and without MCC,
respectively). The applicant believed
that these are the MS–DRGs to which
cases are typically assigned if the
WATCHMAN® System is used in the
principal procedure performed during
the inpatient stay. The applicant
applied the trims in the FY 2015 IPPS/
LTCH PPS final rule (79 FR49910
through 49911), which resulted in 369
cases.
As with its first analysis, the
applicant determined standardized
nondevice charges for the applicable
cases using claims data from the FY
2013 MedPAR file and applied an
inflation factor. The applicant
calculated average nondevice charges by
subtracting what the applicant believed
was the average total implantable device
charges (calculated as the sum of the
five individual device charge fields in
the MedPAR file that constitute the
Implantable Device cost center). Similar
to its first analysis, the applicant then
standardized the charges, applied an
inflation factor of 1.10443, subtracted
the device charges reported on the
MedPAR claims (reflecting costs during
the IDE study) and replaced them with
the anticipated charges following FDA
approval (converting the costs of the
device to charges with a CCR of 0.349
based on the national average
implantable device CCR from the FY
2015 IPPS/LTCH PPS final rule (79 FR
49914)), combined those with the
inflated average case-weighted
standardized charges per case, and
determined a final inflated average caseweighted standardized charge per case
of $117,663. The average case-weighted
threshold amount for these MS–DRGs in
the FY 2015 IPPS Table 10 was $72,804.
Because the final inflated average caseweighted standardized charge per case
exceeds the average case-weighted MS–
DRG threshold amount of $72,804, the
applicant maintained that the
WATCHMAN® System meets the cost
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criterion using this analysis. We note
that the applicant searched for cases
reporting ICD–9–CM procedure code
37.90. In section II.G.3.b. of the
preamble of this proposed rule, we
present a proposal regarding cardiac
ablation and other specified
cardiovascular procedures. Specifically,
we are proposing to assign the
procedures performed within the heart
chambers using intracardiac techniques,
including those identified by ICD–9–CM
procedure code 37.90, to two new
proposed MS–DRGs: Proposed MS–DRG
273 (Percutaneous Intracardiac
Procedures with MCC) and proposed
MS–DRG 274 (Percutaneous
Intracardiac Procedures without MCC).
We believe that this could have
implications for determining whether
the applicant meets the cost criterion.
There have been instances in the past
where the coding associated with a new
technology application is included in a
proposal to change one or more MS–
DRGs. For example, in the FY 2013
IPPS/LTCH PPS final rule, we describe
the cost analysis for the Zenith®
Fenestrated Abdominal Aortic
Aneurysm Endovascular Graft which
was identified by ICD–9–CM procedure
code 39.78. In that same rule, we
finalized a change to the assignment of
that procedure code, reassigning it from
MS–DRGs 252, 253, and 254 to MS–
DRGs 237 and 238. Because of that
change, we determined that, for FY
2013, in order for the Zenith®
Fenestrated Abdominal Aortic
Aneurysm Endovascular Graft to meet
the cost criteria, it must demonstrate
that the average case-weighted
standardized charge per case exceeds
the thresholds for MS–DRGs 237 and
238 (77 FR 55360). We note that in that
example, MS–DRGs 237 and 238 existed
previously; therefore, thresholds that
were 75 percent of one standard
deviation beyond the geometric mean
standardized charge for these DRGs
were available to the public in Table 10
at the time the application was
submitted. In this case, if MS–DRGs 273
and 274 were to be finalized for FY
2016, we recognize that thresholds that
are 75 percent of one standard deviation
beyond the geometric mean
standardized charge would not have
been available at the time the
application was submitted. However,
we believe that it could be appropriate
for the applicant to demonstrate that the
average case-weighted standardized
charge per case exceeds these thresholds
for MS–DRGs 273 and 274. Accordingly,
we intend to calculate supplemental
threshold values using the data used to
generate the FY 2015 IPPS/LTCH PPS
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Table 10 and reassign the procedure
codes in accordance with the proposals
outlined in section II.G.3.b. of the
preamble of this proposed rule. We
intend to make these supplemental
threshold values available for public
consideration on our Web site at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/newtech.html. We
are inviting public comments on
whether considering these supplemental
threshold values as part of the cost
criterion evaluation for this application
is appropriate and also on how to
address similar future situations in a
broader policy context should they
occur. We also are inviting public
comments on the whether the
WATCHMAN® System meets the cost
criterion based on the applicant’s
analysis.
Regarding the substantial clinical
improvement criterion, we note that the
applicant applied for new technology
add-on payments for FY 2015 (as
discussed in the FY 2015 IPPS/LTCH
PPS proposed rule (79 FR 28043
through 28045)). However, prior to the
publication of the FY 2015 IPPS/LTCH
PPS final rule, the applicant withdrew
its application. Before the withdrawal of
the application, CMS stated its concerns
with the application in the FY 2015
IPPS/LTCH PPS proposed rule. The
applicant included responses to CMS’
previous concerns with the FY 2015
application in its FY 2016 application.
Therefore, we are addressing the
applicant’s responses to the previous
concerns specified in the FY 2015 IPPS/
LTCH PPS proposed rule as well as our
observations on the current FY 2016
application in this FY 2016 IPPS/LTCH
PPS proposed rule.
The applicant asserted that the
WATCHMAN® System, a system that
reduces the risk of thromboembolic
stroke in patients diagnosed with highrisk nonvalvular AF who are eligible for
Warfarin therapy, but in whom the
potential risks of Warfarin therapy
outweigh the potential benefits, meets
the substantial clinical improvement
criterion because the WATCHMAN®
System is superior to currently available
treatments. The applicant claimed that
the WATCHMAN® System is ideal for
patients diagnosed with a prior
hemorrhagic stroke while on Warfarin
therapy, patients not adherent to
Warfarin therapy, patients with
difficulty achieving a therapeutic
international normalized ratio (INR),
and patients with an increased risk or
history of falls. The applicant
acknowledged that anticoagulation
using Warfarin therapy or one of the
novel oral anticoagulation agents
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(NOACs), such as dabigatran,
rivaroxaban, or apixaban, is effective for
preventing thromboembolism in
patients who can tolerate such
medication over the long term.
However, these medications are
associated with certain risks. The
applicant stated that the most used and
studied agent, Warfarin, requires dietary
restrictions, has a high-risk of drug
interactions, genetic variability in doseresponse, and the need for frequent
monitoring. According to the applicant,
the average patient diagnosed with AF
and treated with Warfarin therapy
achieves a therapeutic INR for
approximately one-half of the treatment
time. The applicant further stated that
these NOACs also have nonadherence
risks, high discontinuation rates (up to
20 percent within 2 years), are difficult
to monitor effectiveness, and in some
cases have no readily available reversal
strategy.
In support of its assertion that the
WATCHMAN® System is a substantial
improvement, the applicant submitted
data from two pivotal studies
(PROTECT AF and the WATCHMAN®
Left Atrial Appendage Closure Device in
Patients With Atrial Fibrillation Versus
Long-Term Warfarin Therapy
(PREVAIL)). The data included results
of a meta-analysis of the PROTECT AF
and PREVAIL studies, an imputed
placebo analysis, and a post hoc
analysis of the bleeding risks associated
with the WATCHMAN® System.
According to the applicant, the clinical
evidence from these trials and analyses
establish the following: implantation of
the WATCHMAN® System is safe; the
WATCHMAN® System is superior to
Warfarin when evaluated against a
composite endpoint of all stroke,
systemic embolism, and cardiovascular
unexplained death in long-term followup; the WATCHMAN® System provides
a greater reduction in major bleeding
events after the conclusion of post
procedure anti-thrombotic medication;
and the WATCHMAN® System reduces
the incidence of ischemic stroke when
compared to patients diagnosed with AF
who are not treated with Warfarin or
other anticoagulation medication.
We note that, unlike in the FY 2015
application, the applicant did not
include data from the ASAP study. In
the FY 2015 IPPS/LTCH PPS proposed
rule (79 FR 28043 through 28045), we
expressed concerns that data from the
ASAP study suggested that the device
did not prevent strokes and was
insufficient to demonstrate efficacy in
the secondary patient population
(patients diagnosed with AF who were
ineligible for oral anticoagulation). We
specifically stated that the ASAP
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Registry (5) enrolled 150 patients, at one
of four centers, that had a
contraindication to even short-term
anticoagulation, mostly a history of
prior bleeding, and there was no control
group. Device implantation led to a
serious adverse event in 13 patients (8.7
percent), including one case of device
thrombus leading to ischemic stroke.
Five other patients had a device-related
thrombus that did not lead to stroke (4
of these patients were treated with low
molecular weight heparin), resulting in
an overall 4.0 percent incidence (6 out
of 150) of device-associated thrombus.
In the PROTECT AF trial study, 20 of
the 473 patients (4.2 percent) had
device-associated thrombus, 3 of which
led to an ischemic stroke. The rates of
device-related thrombus are similar in
the two studies (4.0 percent versus 4.2
percent), but the number of patients
studied is smaller in the ASAP Registry
(5) study compared to the PROTECT AF
clinical trial study. In the 14-month
follow-up data for the ASAP Registry (5)
study, the rate of stroke or systemic
embolism was 2.3 percent per year,
which was said to be ‘‘lower than
expected’’ based on prior data for
patients diagnosed with AF who were
not treated with warfarin (there was no
concurrent control group). The data
provided suggested efficacy in this
patient population. However, we stated
that we were concerned that there was
not strong evidence that the device
prevents stroke.
In the FY 2016 application, the
applicant responded that, because the
current intended use and indications for
the WATCHMAN® System in the
United States do not include patients
who are ineligible for treatment using
Warfarin therapy, the data from the
ASAP study are irrelevant to the FY
2016 application. The applicant
provided data from an imputed placebo
analysis, a post-hoc analysis that
compared the observed rate of ischemic
strokes in patients treated with the
WATCHMAN® System compared to no
therapy, in order to address our concern
that there was not strong evidence that
the device prevented stroke.
According to the applicant, in the
PROTECT AF trial, 463 patients were
randomized to the WATCHMAN®
System device and 244 patients to
Warfarin therapy. Most patients
randomized to the WATCHMAN®
System device had it implanted (408 =
88 percent). Over the average 3.8 years
of follow-up, more patients in the
Warfarin therapy group withdrew (45
versus 15) or were lost to follow-up (11
versus 13) than in the WATCHMAN®
System device group, leading to shorter
mean follow-up (3.7 versus 3.9 years) in
the Warfarin therapy group.
The applicant presented data shown
in the following table and maintained
that the results of the PROTECT study
demonstrate primary efficacy and
support that the WATCHMAN® System
is noninferior and superior at 4 years.
TABLE 3—PROTECT PRIMARY EFFICACY SUPPORTS WATCHMAN® NON-INFERIORITY AND SUPERIORITY AT 4 YEARS
Patient
years
1065
1588
2621
2717
Years of mean
follow-up
.......
.......
.......
.......
WATCHMAN®
System
observed rate
per 100 patient
years
1.5
2.3
3.8
4
Warfarin
observed rate
per 100
patient years
3
3
2.3
2.2
Posterior probability *
Percentage
reduction vs.
warfarin
(percent)
4.9
4.3
3.8
3.7
Non-inferiority (NI)
(percent)
38
29
40
39
Superiority (S)
(percent)
>99.9
>99.9
>99
>99.9
90.00
84.60
96
95.40
NI.
NI.
NI and S.
NI and S.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
* For Bayesian analysis, a posterior probability of 97.5 percent represents non-inferiority; ≥95 percent represents superiority.
In the FY 2015 IPPS/LTCH PPS
proposed rule, we expressed concern
that the evidence presented by the
applicant demonstrating superiority
compared to Warfarin therapy was
insufficient. We expressed concern that
the PROTECT AF trial was not designed
to demonstrate superiority, and instead
was designed to demonstrate
noninferiority. We also expressed
concern that the PREVAIL trial endpoint
was not significantly improved in the
conventional hypothesis testing
statistical analysis at any time point. We
stated that the longer term data showed
improved efficacy and safety, but still
remain sparse. In the FY 2016
application, the applicant stated that,
under a Bayesian analysis, the
distributions of the posterior
probabilities are not symmetrical.
According to the applicant, posterior
probabilities represent the appropriate
way to determine statistical significance
in Bayesian methodology. As predefined
in the PROTECT AF trial, a posterior
probability for noninferiority of equal to
or more than 97.5 percent, and a
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prespecified level of at least 95 percent
to support superiority were the criteria
for statistical testing. According to the
applicant, in both cases (noninferiority
and superiority), the criteria were met
for long-term follow-up as demonstrated
in the results of the PROTECT AF trial.
We agree that the Bayesian methodology
is a valid method of analysis. However,
we were referencing the overall efficacy
noninferiority in the PREVAIL trial.
We continue to be concerned that the
data results from the PROTECT AF
study are insufficient to show
superiority of the WATCHMAN®
System over Warfarin therapy. We note
that the study was unblinded with a
noninferiority design. We believe that
the reduction in cardiovascular
mortality shown in the results from the
PROTECT AF study was unexpected
and not well explained. Among the 57
patients in the WATCHMAN® System
group who died, only 53 patient cases
were assigned a cause of death and only
5 of the 9 ‘‘unexplained/other deaths’’
were included in the primary endpoint,
although the protocol established that
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unexplained deaths were to be
considered as cardiovascular
mortalities. The total number of
‘‘cardiovascular or unexplained deaths’’
would have been 21, not 17. In the
Warfarin therapy group, there was 1
‘‘unexplained/other’’ death that should
have been included in the primary
endpoint, resulting in a total of 23, not
22. We acknowledge that it may be
difficult to calculate the impact of these
additional events as the intention-totreat analysis of the primary endpoint.
However, we are concerned that the
inclusion of the additional deaths could
have made the posterior probabilities for
the device less favorable. Based on the
data at face value, it appears that the
WATCHMAN® System does not
demonstrate statistically significant
superiority over treatment with
Warfarin therapy until 3.8 years has
elapsed and the patient has been
administered 6 months of oral
anticoagulation and been exposed to the
risk of the device-related complications.
We are concerned that the applicant has
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not demonstrated substantially
improved clinical outcomes.
In the prospective randomized
evaluation of the PREVAIL study, the
goal was to assess the safety and efficacy
of LAA occlusion for stroke prevention
in patients diagnosed with NVAF
compared to long-term Warfarin
therapy. The PREVAIL study was a
confirmatory randomized trial designed
to further assess the efficacy and safety
of the WATCHMAN® System device.
Patient selection and study design were
similar to the PROTECT AF study. Two
efficacy and 1 safety coprimary
endpoints were assessed at 18 months.
The rate of the first coprimary efficacy
endpoint overall efficacy (composite of
stroke, systemic embolism [SE], and
cardiovascular/unexplained death) was
0.064 in the WATCHMAN® System
device group versus 0.063 in the control
group (rate ratio 1.07 [95 percent
credible interval (CrI) 0.57 to 1.89]) and
did not achieve the prespecified criteria
of noninferiority (upper boundary of 95
percent CrI 1.75). The rate for the
second coprimary efficacy endpoint
(stroke or SE >7 days’
postrandomization) was 0.0253 versus
0.0200 (risk difference 0.0053 [95
percent CrI –0.0190 to 0.0273]), which
achieved noninferiority. Early safety
events were significantly lower than the
results of the PROTECT AF study,
which satisfies the prespecified safety
performance goal. The PREVAIL study
was designed to demonstrate
noninferiority with wide efficacy
margins. However, as previously stated,
we are concerned that the results of the
study did not show the overall efficacy
of the technology to be noninferior.
The applicant submitted data from a
patient-level meta-analysis that
combined the data from the PROTECT
AF study with the data from the
PREVAIL study. According to the
applicant, this analysis supports the
efficacy of the WATCHMAN® System
and shows that the device was
performing as expected compared to the
Warfarin therapy control arm. The
datasets were combined and weighted.
According to the applicant, multiple
outcomes of interest were examined,
starting with the primary efficacy
endpoint and then looking at individual
outcomes: All stroke (ischemic and
hemorrhagic) and associated disability;
systemic embolism; cardiovascular/
unexplained death; and major bleeding.
The overall incidence of all strokes
(ischemic and hemorrhagic) was not
statistically different in the
WATCHMAN® System arm and the
Warfarin therapy arm. However, the
applicant stated that there were
statistical differences identified when it
analyzed the stroke subtypes. The
applicant indicated that, initially, there
were more ischemic strokes in the
WATCHMAN® System arm. However,
after accounting for early procedural
complications, including strokes (within
7 days post procedure) in the PROTECT
AF study, the difference for ischemic
stroke between the two arms fell below
statistical significance (p = 0.21).
According to the applicant, there were
significantly more hemorrhagic strokes
and cardiovascular deaths in the
Warfarin therapy arm compared to the
WATCHMAN® System arm, showing a
78 percent and 52 percent reduction in
those events respectively (p = 0.004 and
p = 0.006). To better assess the clinical
impact of the different subtypes of
strokes on patients, the applicant also
performed statistical tests on disabilities
resulting from stroke. The applicant
indicated that, using a validated stroke
severity assessment tool (Modified
Rankin score), analyses show that there
were significantly less disabling strokes
with the WATCHMAN® System than
Warfarin therapy. The applicant
believed that this represents a
substantial clinical improvement for the
WATCHMAN® System device.
The applicant conducted an imputed
placebo analysis to assess the benefit
that untreated patients may expect with
the WATCHMAN® System device. The
applicant contended that many patients
who are eligible for Warfarin therapy are
not receiving any treatment and,
therefore, are left unprotected from
stroke. With annual ischemic stroke
rates ranging from 5.6 percent to 7.1
percent, the applicant maintained that
the WATCHMAN® System device
provides a substantive clinical benefit.
In order to assess the benefit that
untreated patients may be able to expect
with the WATCHMAN® System, the
sponsor performed the following
exploratory analysis. The observed
device ischemic strokes rates were
compared against the estimated stroke
risk of untreated nonvalvular AF
patients. A placebo arm was then
constructed using ‘‘well-established,
validated literature’’ models based on
both the CHADS2 and CHA2DS2–VASc
scores. The applicant reported that this
analysis showed the WATCHMAN®
System device reduced stroke in the
untreated patient population by 61 to 81
percent.
We previously expressed concern that
there was a lack of strong evidence
demonstrating that the WATCHMAN®
System prevents stroke at all. The
applicant responded that the imputed
placebo analysis cited above addresses
this concern. The applicant provided
the table below as part of its FY 2016
application to show the relative risk
reduction in Ischemic stroke rates using
the WATCHMAN® System versus no
therapy.
TABLE 5—WATCHMAN® SHOWS SIGNIFICANT REDUCTION IN ISCHEMIC STROKES COMPARED TO NO THERAPY
Average CHADS
(2 footnote on
acronym) score
WATCHMAN®
patients
Study
tkelley on DSK3SPTVN1PROD with PROPOSALS2
PROTECT AF ..........................................................................
PREVAIL-only ..........................................................................
CAP ..........................................................................................
While the results of this analysis
appear to suggest a large reduction in
ischemic stroke rates in patients who
did not receive any treatment, we
continue to have some concerns
regarding whether the WATCHMAN®
System device prevents strokes. The
indication for the treatment of the
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2.2
2.6
2.5
Observed
WATCHMAN®
annual ischemic
stroke rate
(95 percent CI)
1.3 (0.9, 2.0)
2.3 (1.3, 4.0)
1.2 (0.8, 1.8)
WATCHMAN® System device is for
patients who are eligible for Warfarin
therapy as opposed to patients who are
ineligible for Warfarin therapy. We are
concerned that the results of the
imputed placebo analysis are not
sufficient to determine whether the
WATCHMAN® System reduces the risk
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Imputed untreated
annual event rate
5.6–5.7
6.6–6.7
6.4
Relative risk
reduction
77% (64%, 84%)
65% (39%, 80%)
81% (72%, 88%)
of stroke in patients who are eligible for
Warfarin therapy. The applicant
suggested that patients who are
subtherapeutic or noncompliant with
Warfarin therapy would have the same
risk of stroke as patients who do not
receive any therapy. However, the
applicant but did not offer any evidence
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that these two groups have the same risk
of stroke. The WATCHMAN® System
device is intended only for use in
patients who are eligible for the
anticoagulation, not for patients who
have contraindications to oral
anticoagulation. Because the device will
not be labeled for use in those patients,
we believe that an analysis comparing
stroke risk of untreated patients to those
patients treated with the WATCHMAN®
System is of limited value in assessing
the technology’s benefit over existing
therapy.
The applicant asserted that one of the
primary goals of mechanical LAA
closure is to provide an alternative
treatment for patients other than longterm Warfarin therapy and exposure to
the associated risk for bleeding.
Although the primary efficacy endpoint
of the PROTECT AF and PREVAIL
studies considered hemorrhagic stroke,
it did not encompass other types of
major bleeding that may be associated
with the use of Warfarin. The applicant
indicated that it performed a
supplemental analysis to determine the
relative risks of all types of bleeding.
The applicant divided the follow-up
interval into four subsections (7 days, 45
days, 6 months, and 54 months). The
applicant compared bleeding events in
the WATCHMAN® System group with
the Warfarin therapy group and
concluded that, after 6 months (and
discontinued use of Clopidogrel in the
WATCHMAN® System group), the
continued use of Warfarin was
associated with a 3.4 fold increase in the
risk of major bleeding. According to the
applicant, the significant reduction in
bleeding after the procedural and
concomitant medication therapy (6
months) with the cessation of long-term
anticoagulants illustrates the substantial
clinical benefit of the WATCHMAN®
System. However, given the high burden
endured (most notably, the higher risk
of bleeding occurring in the first 7 days
of an inpatient hospital stay) to achieve
a reduction in bleeding in the long term,
we do not believe that the
WATCHMAN® System meets the
criteria for substantially improved
clinical outcomes. We are inviting
public comments on whether this
technology meets the substantial
clinical improvement criterion,
particularly in light of the applicant’s
response to our previous concerns and
our current concern that there remains
insufficient evidence that the
WATCHMAN® System substantially
improves clinical outcomes in patients
diagnosed with nonvalvular AF and
who are eligible for Warfarin therapy.
We did not receive any public
comments in response to the New
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Technology Town Hall meeting held on
February 13, 2015 in regard to the
WATCHMAN® System technology.
III. Proposed Changes to the Hospital
Wage Index for Acute Care Hospitals
A. Background
1. Legislative Authority
Section 1886(d)(3)(E) of the Act
requires that, as part of the methodology
for determining prospective payments to
hospitals, the Secretary adjust the
standardized amounts for area
differences in hospital wage levels by a
factor (established by the Secretary)
reflecting the relative hospital wage
level in the geographic area of the
hospital compared to the national
average hospital wage level. We
currently define hospital labor market
areas based on the delineations of
statistical areas established by the Office
of Management and Budget (OMB). A
discussion of the proposed FY 2016
hospital wage index based on the
statistical areas appears under sections
III.A.2. and G. of the preamble of this
proposed rule.
Section 1886(d)(3)(E) of the Act
requires the Secretary to update the
wage index annually and to base the
update on a survey of wages and wagerelated costs of short-term, acute care
hospitals. This provision also requires
that any updates or adjustments to the
wage index be made in a manner that
ensures that aggregate payments to
hospitals are not affected by the change
in the wage index. The proposed
adjustment for FY 2016 is discussed in
section II.B. of the Addendum to this
proposed rule.
As discussed in section III.J. of the
preamble of this proposed rule, we also
take into account the geographic
reclassification of hospitals in
accordance with sections 1886(d)(8)(B)
and 1886(d)(10) of the Act when
calculating IPPS payment amounts.
Under section 1886(d)(8)(D) of the Act,
the Secretary is required to adjust the
standardized amounts so as to ensure
that aggregate payments under the IPPS
after implementation of the provisions
of sections 1886(d)(8)(B), 1886(d)(8)(C),
and 1886(d)(10) of the Act are equal to
the aggregate prospective payments that
would have been made absent these
provisions. The proposed budget
neutrality adjustment for FY 2016 is
discussed in section II.A.4.b. of the
Addendum to this proposed rule.
Section 1886(d)(3)(E) of the Act also
provides for the collection of data every
3 years on the occupational mix of
employees for short-term, acute care
hospitals participating in the Medicare
program, in order to construct an
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24463
occupational mix adjustment to the
wage index. A discussion of the
occupational mix adjustment that we
are proposing to apply, beginning
October 1, 2015 (to the FY 2016 wage
index), appears under sections III.E.3.
and F. of the preamble of this proposed
rule.
2. Core-Based Statistical Areas (CBSAs)
for the Proposed Rule
The wage index is calculated and
assigned to hospitals on the basis of the
labor market area in which the hospital
is located. Under section 1886(d)(3)(E)
of the Act, beginning with FY 2005, we
delineate hospital labor market areas
based on OMB-established Core-Based
Statistical Areas (CBSAs). The current
statistical areas (which were
implemented beginning with FY 2015)
are based on revised OMB delineations
issued on February 28, 2013, in OMB
Bulletin No. 13–01. OMB Bulletin No.
13–01 established revised delineations
for Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and
Combined Statistical Areas in the
United States and Puerto Rico, and
provided guidance on the use of the
delineations of these statistical areas
based on new standards published on
June 28, 2010 in the Federal Register
(75 FR 37246 through 37252) and the
2010 Census of Population and Housing
data (we refer to these revised OMB
delineations as the ‘‘new OMB
delineations’’ in this proposed rule). A
copy of this bulletin may be obtained at
https://www.whitehouse.gov/sites/
default/files/omb/bulletins/2013/b-1301.pdf. We refer readers to the FY 2015
IPPS/LTCH PPS final rule (79 FR 49951
through 49963) for a full discussion of
our implementation of the new OMB
labor market area delineations for the
FY 2015 wage index. For FY 2016, we
are continuing to use the new OMB
delineations that we adopted beginning
with FY 2015 to calculate the area wage
indexes and the transition periods,
which we discuss below.
B. Worksheet S–3 Wage Data for the
Proposed FY 2016 Wage Index
The proposed FY 2016 wage index
values are based on the data collected
from the Medicare cost reports
submitted by hospitals for cost reporting
periods beginning in FY 2012 (the FY
2015 wage indexes were based on data
from cost reporting periods beginning
during FY 2011).
1. Included Categories of Costs
The proposed FY 2016 wage index
includes the following categories of data
associated with costs paid under the
IPPS (as well as outpatient costs):
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• Salaries and hours from short-term,
acute care hospitals (including paid
lunch hours and hours associated with
military leave and jury duty);
• Home office costs and hours;
• Certain contract labor costs and
hours (which includes direct patient
care, certain top management,
pharmacy, laboratory, and nonteaching
physician Part A services, and certain
contract indirect patient care services
(as discussed in the FY 2008 final rule
with comment period (72 FR 47315
through 47318)); and
• Wage-related costs, including
pension costs (based on policies
adopted in the FY 2012 IPPS/LTCH PPS
final rule (76 FR 51586 through 51590))
and other deferred compensation costs.
2. Excluded Categories of Costs
Consistent with the wage index
methodology for FY 2015, the proposed
wage index for FY 2016 also excludes
the direct and overhead salaries and
hours for services not subject to IPPS
payment, such as skilled nursing facility
(SNF) services, home health services,
costs related to GME (teaching
physicians and residents) and certified
registered nurse anesthetists (CRNAs),
and other subprovider components that
are not paid under the IPPS. The
proposed FY 2016 wage index also
excludes the salaries, hours, and wagerelated costs of hospital-based rural
health clinics (RHCs), and Federally
qualified health centers (FQHCs)
because Medicare pays for these costs
outside of the IPPS (68 FR 45395). In
addition, salaries, hours, and wagerelated costs of CAHs are excluded from
the proposed wage index for the reasons
explained in the FY 2004 IPPS final rule
(68 FR 45397 through 45398).
tkelley on DSK3SPTVN1PROD with PROPOSALS2
3. Use of Wage Index Data by Suppliers
and Providers Other Than Acute Care
Hospitals Under the IPPS
Data collected for the IPPS wage
index also are currently used to
calculate wage indexes applicable to
suppliers and other providers, such as
SNFs, home health agencies (HHAs),
ambulatory surgical centers (ASCs), and
hospices. In addition, they are used for
prospective payments to IRFs, IPFs, and
LTCHs, and for hospital outpatient
services. We note that, in the IPPS rules,
we do not address comments pertaining
to the wage indexes of any supplier or
provider except IPPS providers and
LTCHs. Such comments should be made
in response to separate proposed rules
for those suppliers and providers.
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C. Verification of Worksheet S–3 Wage
Data
The wage data for the proposed FY
2016 wage index were obtained from
Worksheet S–3, Parts II and III of the
Medicare cost report for cost reporting
periods beginning on or after October 1,
2011, and before October 1, 2012. For
wage index purposes, we refer to cost
reports during this period as the ‘‘FY
2012 cost report,’’ the ‘‘FY 2012 wage
data,’’ or the ‘‘FY 2012 data.’’
Instructions for completing the wage
index sections of Worksheet S–3 are
included in the Provider
Reimbursement Manual (PRM), Part 2
(Pub. No. 15–2), Chapter 40, Sections
4005.2 through 4005.4 for Form CMS–
2552–10. The data file used to construct
the proposed FY 2016 wage index
includes FY 2012 data submitted to us
as of February 25, 2015. As in past
years, we performed an extensive
review of the wage data, mostly through
the use of edits designed to identify
aberrant data.
We asked our MACs to revise or verify
data elements that result in specific edit
failures. For the proposed FY 2016 wage
index, we identified and excluded 93
providers with aberrant data that should
not be included in the proposed wage
index. If data elements for some of these
providers with aberrant data are
corrected, we intend to include data
from those providers in the final FY
2016 wage index. We also adjusted
certain aberrant data elements within a
provider’s data and included these data
in the proposed wage index. For
example, in situations where a hospital
did not have documentable salaries,
wages, and hours for contract
housekeeping and dietary services, we
imputed estimates, in accordance with
established policies as discussed in the
FY 2015 IPPS/LTCH PPS final rule (79
FR 49965 through 49967). We instructed
MACs to complete their data
verification of questionable data
elements and to transmit any changes to
the wage data no later than February 25,
2015. We intend to resolve all
unresolved data elements by the date
the FY 2016 IPPS/LTCH PPS final rule
is issued. The revised data will be
reflected in the FY 2016 IPPS/LTCH
PPS final rule.
In constructing the proposed FY 2016
wage index, we included the wage data
for facilities that were IPPS hospitals in
FY 2012, inclusive of those facilities
that have since terminated their
participation in the program as
hospitals, as long as those data did not
fail any of our edits for reasonableness.
We believe that including the wage data
for these hospitals is, in general,
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appropriate to reflect the economic
conditions in the various labor market
areas during the relevant past period
and to ensure that the current wage
index represents the labor market area’s
current wages as compared to the
national average of wages. However, we
excluded the wage data for CAHs as
discussed in the FY 2004 IPPS final rule
(68 FR 45397 through 45398). For this
FY 2016 IPPS/LTCH PPS proposed rule,
we removed 12 hospitals that converted
to CAH status on or after February 13,
2014, the cut-off date for CAH exclusion
from the FY 2015 wage index, and
through and including February 5, 2015,
the cut-off date for CAH exclusion from
the FY 2016 wage index. After removing
hospitals with aberrant data and
hospitals that converted to CAH status,
we calculated the proposed FY 2016
wage index based on 3,335 hospitals.
For the proposed FY 2016 wage
index, we allotted the wages and hours
data for a multicampus hospital among
the different labor market areas where
its campuses are located in the same
manner that we allotted such hospitals’
data in the FY 2015 wage index (79 FR
49964). Table 2, which contains the
proposed FY 2016 wage index
associated with this proposed rule
(available via the Internet on the CMS
Web site), includes separate wage data
for the campuses of 7 multicampus
hospitals.
D. Method for Computing the Proposed
FY 2016 Unadjusted Wage Index
The method used to compute the
proposed FY 2016 wage index without
an occupational mix adjustment follows
the same methodology that we used to
compute the FY 2012, FY 2013, FY
2014, and FY 2015 final wage indexes
without an occupational mix adjustment
(76 FR 51591 through 51593, 77 FR
53366 through 53367, 78 FR 50587
through 50588, and 79 FR 49967,
respectively).
As discussed in the FY 2012 IPPS/
LTCH PPS final rule, in ‘‘Step 5,’’ for
each hospital, we adjust the total
salaries plus wage-related costs to a
common period to determine total
adjusted salaries plus wage-related
costs. To make the wage adjustment, we
estimate the percentage change in the
employment cost index (ECI) for
compensation for each 30-day
increment from October 14, 2011,
through April 15, 2013, for private
industry hospital workers from the BLS’
Compensation and Working Conditions.
We have consistently used the ECI as
the data source for our wages and
salaries and other price proxies in the
IPPS market basket, and we are not
proposing any changes to the usage for
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FY 2016. The factors used to adjust the
hospital’s data were based on the
midpoint of the cost reporting period, as
indicated in the following table.
MIDPOINT OF COST REPORTING
PERIOD
After
Before
Adjustment
factor
10/14/2011
11/14/2011
12/14/2011
01/14/2012
02/14/2012
03/14/2012
04/14/2012
05/14/2012
06/14/2012
07/14/2012
08/14/2012
09/14/2012
10/14/2012
11/14/2012
12/14/2012
01/14/2013
02/14/2013
03/14/2013
11/15/2011
12/15/2011
01/15/2012
02/15/2012
03/15/2012
04/15/2012
05/15/2012
06/15/2012
07/15/2012
08/15/2012
09/15/2012
10/15/2012
11/15/2012
12/15/2012
01/15/2013
02/15/2013
03/15/2013
04/15/2013
1.02167
1.02029
1.01893
1.01756
1.01620
1.01484
1.01348
1.01213
1.01080
1.00951
1.00825
1.00699
1.00568
1.00433
1.00292
1.00148
1.00000
0.98259
For example, the midpoint of a cost
reporting period beginning January 1,
2012, and ending December 31, 2012, is
June 30, 2012. An adjustment factor of
1.01080 would be applied to the wages
of a hospital with such a cost reporting
period.
Using the data as described above, the
proposed FY 2016 national average
hourly wage (unadjusted for
occupational mix) is $40.1203. The
proposed FY 2016 Puerto Rico overall
average hourly wage (unadjusted for
occupational mix) is $16.718.
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E. Proposed Occupational Mix
Adjustment to the FY 2016 Wage Index
As stated earlier, section 1886(d)(3)(E)
of the Act provides for the collection of
data every 3 years on the occupational
mix of employees for each short-term,
acute care hospital participating in the
Medicare program, in order to construct
an occupational mix adjustment to the
wage index, for application beginning
October 1, 2004 (the FY 2005 wage
index). The purpose of the occupational
mix adjustment is to control for the
effect of hospitals’ employment choices
on the wage index. For example,
hospitals may choose to employ
different combinations of registered
nurses, licensed practical nurses,
nursing aides, and medical assistants for
the purpose of providing nursing care to
their patients. The varying labor costs
associated with these choices reflect
hospital management decisions rather
than geographic differences in the costs
of labor.
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1. Development of Data for the Proposed
FY 2016 Occupational Mix Adjustment
Based on the 2013 Medicare Wage Index
Occupational Mix Survey
As provided for under section
1886(d)(3)(E) of the Act, we collect data
every 3 years on the occupational mix
of employees for each short-term, acute
care hospital participating in the
Medicare program.
As discussed in the FY 2015 IPPS/
LTCH PPS final rule (79 FR 49967
through 49968), the occupational mix
adjustment to the FY 2015 wage index
was based on data collected on the 2010
Occupational Mix Survey Hospital
Reporting Form (CMS–10079 (2010)).
For the proposed FY 2016 wage index,
we are proposing to use the
occupational mix data collected on the
new 2013 survey to compute the
occupational mix adjustment for FY
2016, as discussed in section II.B.2. of
the preamble of this proposed rule.
2. New 2013 Occupational Mix Survey
for the Proposed FY 2016 Wage Index
Section 304(c) of Public Law 106–554
amended section 1886(d)(3)(E) of the
Act to require CMS to collect data every
3 years on the occupational mix of
employees for each short-term, acute
care hospital participating in the
Medicare program. We collected data in
2010 to compute the occupational mix
adjustment for the FY 2013, FY 2014,
and FY 2015 wage index. Therefore, we
were required to collect data in 2013
and are using these data to compute the
occupational mix adjustment for the FY
2016 wage index.
On December 7, 2012, we published
in the Federal Register a notice
soliciting comments on the proposed
2013 Medicare Wage Index
Occupational Mix Survey (77 FR 73032
through 73033). The new 2013 survey,
which is being applied to the proposed
FY 2016 wage index, includes the same
data elements and definitions as the
2010 survey and provides for the
collection of hospital-specific wages and
hours data for nursing employees for
calendar year 2013 (that is, payroll
periods ending between January 1, 2013
and December 31, 2013). The comment
period for the notice ended on February
5, 2013. After considering the public
comments that we received on the
December 2012 notice, we made a few
minor editorial changes and published
the 2013 survey in the Federal Register
on February 28, 2013 (78 FR 13679
through 13680). This survey was
approved by OMB on May 14, 2013, and
is available on the CMS Web site at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
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24465
AcuteInpatientPPS/Downloads/WAGEINDEX-OCCUPATIONAL-MIXSURVEY2013.pdf.
The 2013 Occupational Mix Survey
Hospital Reporting Form CMS–10079
for the Wage Index Beginning FY 2016
(in Excel format) is available on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/WageIndex-Files-Items/Medicare-WageIndex-Occupational-MixSurvey2013.html?DLPage=
1&DLSort=1&DLSortDir=descending.
Hospitals were required to submit their
completed 2013 surveys to their MACs
by July 1, 2014. The preliminary,
unaudited 2013 survey data were posted
on the CMS Web site afterward, on July
11, 2014.
As with the Worksheet S–3 cost report
wage data, we asked our MACs to revise
or verify data elements in hospitals’
occupational mix surveys that resulted
in certain edit failures. Certain surveys
with aberrant data elements are
excluded from the proposed FY 2016
wage index, but any data elements
resolved and revised in time to be
included in the final wage index will be
reflected in the FY 2016 IPPS/LTCH
PPS final rule.
3. Calculation of the Proposed
Occupational Mix Adjustment for FY
2016
For FY 2016, we are proposing to
calculate the occupational mix
adjustment factor using the same
methodology that we used for the FY
2012, FY 2013, FY 2014, and FY 2015
wage indexes (76 FR 51582 through
51586, 77 FR 53367 through 53368, 78
FR 50588 through 50589, and 79 FR
49968, respectively). As a result of
applying this methodology, the
proposed FY 2016 occupational mix
adjusted national average hourly wage is
$40.0853. The proposed FY 2016
occupational mix adjusted Puerto Ricospecific average hourly wage is
$16.6329.
Because the occupational mix
adjustment is required by statute, all
hospitals that are subject to payments
under the IPPS, or any hospital that
would be subject to the IPPS if not
granted a waiver, must complete the
occupational mix survey, unless the
hospital has no associated cost report
wage data that are included in the FY
2016 wage index. For the proposed FY
2016 wage index, because we are using
the Worksheet S–3, Parts II and III wage
data of 3,335 hospitals, and we are using
the occupational mix surveys of 3,039
hospitals for which we also have
Worksheet S–3 wage data, that
represents a ‘‘response’’ rate of 91.1
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percent (3,039/3,335). In the proposed
FY 2016 wage index in this proposed
rule, we applied proxy data for
noncompliant hospitals, new hospitals,
or hospitals that submitted erroneous or
aberrant data in the same manner that
we applied proxy data for such
hospitals in the FY 2012 wage index
occupational mix adjustment (76 FR
51586).
In the FY 2011 IPPS/LTCH PPS
proposed rule and final rule (75 FR
23943 and 75 FR 50167, respectively),
we stated that, in order to gain a better
understanding of why some hospitals
are not submitting the occupational mix
data, we will require hospitals that do
not submit occupational mix data to
provide an explanation for not
complying. This requirement was
effective for the 2013 occupational mix
survey as well as the 2010 occupational
mix survey. We instructed MACs to
continue gathering this information as
part of the FY 2016 wage index desk
review process. We stated that we
would review these data for future
analysis and consideration of potential
penalties for noncompliant hospitals.
F. Analysis and Implementation of the
Proposed Occupational Mix Adjustment
and the Proposed FY 2016 Occupational
Mix Adjusted Wage Index
As discussed in section III.E. of the
preamble of this proposed rule, for FY
2016, we apply the occupational mix
adjustment to 100 percent of the
proposed FY 2016 wage index. We
calculated the proposed occupational
mix adjustment using data from the
2013 occupational mix survey data,
using the methodology described in the
FY 2012 IPPS/LTCH PPS final rule (76
FR 51582 through 51586).
Using the occupational mix survey
data and applying the occupational mix
adjustment to 100 percent of the
proposed FY 2016 wage index results in
a proposed national average hourly
wage of $40.0853 and a proposed
Puerto-Rico specific average hourly
wage of $16.6329. After excluding data
of hospitals that either submitted
aberrant data that failed critical edits or
that did not have FY 2012 Worksheet S–
3, Parts II and III, cost report data for use
in calculating the proposed FY 2016
wage index, we calculated the proposed
FY 2016 wage index using the
occupational mix survey data from
3,039 hospitals. For the proposed FY
2016 wage index, because we are using
the Worksheet S–3, Parts II and III wage
data of 3,335 hospitals, and we are using
the occupational mix survey data of
3,039 hospitals for which we also have
Worksheet S–3 wage data, those data
represent a ‘‘response’’ rate of 91.1
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percent (3,039/3,335). The proposed FY
2016 national average hourly wages for
each occupational mix nursing
subcategory as calculated in Step 2 of
the occupational mix calculation are as
follows:
Occupational mix nursing
subcategory
Proposed
average
hourly wage
National RN ..........................
National LPN and Surgical
Technician .........................
National Nurse Aide, Orderly,
and Attendant ....................
National Medical Assistant ...
National Nurse Category ......
38.70789914
22.793680926
15.944111418
18.009577806
32.783151666
The proposed national average hourly
wage for the entire nurse category as
computed in Step 5 of the occupational
mix calculation is $32.783151666.
Hospitals with a nurse category average
hourly wage (as calculated in Step 4 of
the occupational mix calculation) of
greater than the national nurse category
average hourly wage receive an
occupational mix adjustment factor (as
calculated in Step 6 of the occupational
mix calculation) of less than 1.0.
Hospitals with a nurse category average
hourly wage (as calculated in Step 4 of
the occupational mix calculation) of less
than the national nurse category average
hourly wage receive an occupational
mix adjustment factor (as calculated in
Step 6 of the occupational mix
calculation) of greater than 1.0.
Based on the 2013 occupational mix
survey data, we determined (in Step 7
of the occupational mix calculation) that
the national percentage of hospital
employees in the nurse category is 42.54
percent, and the national percentage of
hospital employees in the all other
occupations category is 57.46 percent.
At the CBSA level, the percentage of
hospital employees in the nurse
category ranged from a low of 26.72
percent in one CBSA to a high of 80.55
percent in another CBSA.
The proposed FY 2016 Puerto Ricospecific average hourly wages for each
occupational mix nursing subcategory
as calculated in Step 2 of the
occupational mix calculation are as
follows:
Proposed
Puerto Rico
average
hourly wage
Occupational mix nursing
subcategory
Puerto Rico RN ....................
Puerto Rico LPN and Surgical Technician ................
Puerto Rico Nurse Aide, Orderly, and Attendant ..........
Puerto Rico Medical Assistant .....................................
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16.762672135
10.053073049
9.695410146
21.962356196
Sfmt 4702
Occupational mix nursing
subcategory
Proposed
Puerto Rico
average
hourly wage
Puerto Rico Nurse Category
14.563182257
Based on the 2013 occupational mix
survey data, we determined (in Step 7
of the occupational mix calculation) that
the Puerto Rico percentage of hospital
employees in the nurse category is 49.93
percent, and the Puerto Rico percentage
of hospital employees in the all other
occupations category is 50.07 percent.
We also compared the proposed FY
2016 wage data adjusted for
occupational mix from the 2013 survey
to the proposed FY 2016 wage data
adjusted for occupational mix from the
2010 survey. This analysis illustrates
the effect on area wage indexes of using
the 2013 survey data compared to the
2010 survey data; that is, it shows
whether hospitals’ wage indexes would
increase or decrease under the 2013
survey data as compared to the prior
2010 survey data. Of the 407 urban
CBSAs and 47 rural CBSAs, our analysis
shows that the proposed FY 2016 wage
index values for 183 (45.0 percent)
urban areas and 20 (42.6 percent) rural
areas would increase. Fifty-three (13.0
percent) urban areas would increase by
greater than or equal to 1 percent but
less than 5 percent, and 5 (1.2 percent)
urban areas would increase by 5 percent
or more. Four (8.5 percent) rural areas
would increase by greater than or equal
to 1 percent but less than 5 percent, and
no rural areas would increase by 5
percent or more. However, the proposed
wage index values for 220 (54.1 percent)
urban areas and 27 (57.4 percent) rural
areas would decrease using the 2013
survey data. Seventy-two (17.7 percent)
urban areas would decrease by greater
than or equal to 1 percent but less than
5 percent, and one (0.2 percent) urban
area would decrease by 5 percent or
more. Seven (14.9 percent) rural areas
would decrease by greater than or equal
to 1 percent but less than 5 percent, and
no rural areas would decrease by 5
percent or more. The largest positive
impacts using the 2013 survey data
compared to the 2010 survey data are
15.0 percent for an urban area and 3.8
percent for a rural area. The largest
negative impacts are 5.0 percent for an
urban area and 1.9 percent for two rural
areas. Four urban areas and no rural
areas would be unaffected. These results
indicate that the proposed wage indexes
of more CBSAs overall (54.4 percent)
would decrease due to application of
the 2013 occupational mix survey data
as compared to the 2010 occupational
mix survey data to the wage index.
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Further, a larger percentage of urban
areas (45.0 percent) would benefit from
the use of the 2013 occupational mix
survey data as compared to the 2010
occupational mix survey data than
would rural areas (42.6 percent).
We compared the proposed FY 2016
occupational mix adjusted wage indexes
for each CBSA to the proposed
unadjusted wage indexes for each
CBSA. As a result of applying the
occupational mix adjustment to the
wage data, the proposed wage index
values for 222 (54.5 percent) urban areas
and 24 (51.1 percent) rural areas would
increase. One hundred one (24.8
percent) urban areas would increase by
greater than or equal to 1 percent but
less than 5 percent, and 6 (1.5 percent)
urban areas would increase by 5 percent
or more. Nine (19.1 percent) rural areas
would increase by greater than or equal
to 1 percent but less than 5 percent, and
no rural areas would increase by 5
percent or more. However, the proposed
wage index values for 185 (45.5 percent)
urban areas and 23 (48.9 percent) rural
areas would decrease. Ninety-three (22.9
percent) urban areas would decrease by
greater than or equal to 1 percent but
less than 5 percent, and no urban areas
would decrease by 5 percent or more.
Eight (17.0 percent) rural areas would
decrease by greater than or equal to 1
percent but less than 5 percent, and no
rural areas would decrease by 5 percent
or more. The largest positive impacts
would be 17.4 percent for an urban area
and 2.7 percent for two rural areas. The
largest negative impacts would be 4.7
percent for an urban area and 2.1
percent for a rural area. No urban or
rural areas would remain unchanged by
application of the proposed
occupational mix adjustment. These
results indicate that a larger percentage
of urban areas (54.5 percent) would
benefit from application of the proposed
occupational mix adjustment than
would rural areas (51.1 percent).
tkelley on DSK3SPTVN1PROD with PROPOSALS2
G. Transitional Wage Indexes
1. Background
In the FY 2015 IPPS/LTCH PPS
proposed rule and final rule (79 FR
28060 and 49957, respectively), we
stated that, overall, we believed
implementing the new OMB labor
market area delineations would result in
wage index values being more
representative of the actual costs of
labor in a given area. However, we
recognized that some hospitals would
experience decreases in wage index
values as a result of the implementation
of these new OMB labor market area
delineations. We also realized that some
hospitals would have higher wage index
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values due to the implementation of the
new OMB labor market area
delineations.
The FY 2015 IPPS/LTCH PPS final
rule (79 FR 49957) explained the
methodology utilized in implementing
prior transition periods when adopting
changes that have significant payment
implications, particularly large negative
impacts. Specifically, for FY 2005, in
the FY 2005 IPPS final rule (69 FR
49032 through 49034), we provided
transitional wage indexes when the
OMB definitions were implemented
after the 2000 Census. The FY 2015
IPPS/LTCH PPS final rule (79 FR 49957
through 49962) established similar
transition methodologies to mitigate any
negative payment impacts experienced
by hospitals due to our adoption of the
new OMB labor market area
delineations for FY 2015.
As finalized in the FY 2015 IPPS/
LTCH PPS final rule (79 FR 49957
through 49960) and as discussed below,
for FY 2016, we are in the second year
of two 3-year transition periods for wage
index: one for hospitals that, for FY
2014, were located in an urban county
that became rural under the new OMB
delineations, and had no form of wage
index reclassification or redesignation
in place for FY 2015 (that is, MGCRB
reclassifications under section
1886(d)(10) of the Act, redesignations
under section 1886(d)(8)(B) of the Act,
or rural reclassifications under section
1886(d)(8)(E) of the Act); and one for
hospitals deemed urban under section
1886(d)(8)(B) of the Act where the urban
area became rural under the new OMB
delineations. In addition, the 1-year
transition that we applied in FY 2015
for hospitals that experienced a decrease
in wage index under the new OMB
delineations expires at the end of FY
2015 and does not apply in FY 2016.
2. Transition for Hospitals in Urban
Areas That Became Rural
In the FY 2015 IPPS/LTCH PPS final
rule (79 FR 49957 through 49959), for
hospitals that, for FY 2014, were located
in an urban county that became rural
under the new OMB delineations, and
had no form of wage index
reclassification or redesignation in place
for FY 2015 (that is, MGCRB
reclassifications under section
1886(d)(10) of the Act, redesignations
under section 1886(d)(8)(B) of the Act,
or rural reclassifications under section
1886(d)(8)(E) of the Act), we adopted a
policy to assign them the urban wage
index value of the CBSA in which they
are physically located for FY 2014 for a
period of 3 fiscal years (with the rural
and imputed floors applied and with the
rural floor budget neutrality adjustment
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24467
applied to the area wage index). FY
2016 will represent the second year of
this transition policy, and we are not
proposing any changes to this policy in
this proposed rule. In the FY 2015 IPPS/
LTCH PPS final rule (79 FR 49957), we
stated our belief that it is appropriate to
apply a 3-year transition period for
hospitals located in urban counties that
would become rural under the new
OMB delineations, given the potentially
significant payment impacts for these
hospitals. We continue to believe that
assigning the wage index of the
hospitals’ FY 2014 area for a 3-year
transition is the simplest and most
effective method for mitigating negative
payment impacts due to the adoption of
the new OMB delineations.
In the FY 2015 IPPS/LTCH PPS final
rule (79 FR49959), we noted that there
were situations where a hospital could
not be assigned the wage index value of
the CBSA in which it geographically
was located in FY 2014 because that
CBSA split and no longer exists and
some or all of the constituent counties
were added to another urban labor
market area under the new OMB
delineations. If the hospital could not be
assigned the wage index value of the
CBSA in which it was geographically
located in FY 2014 because that CBSA
split apart and no longer exists, and
some or all of its constituent counties
were added to another urban labor
market area under the new OMB
delineations, we established that
hospitals located in such counties that
became rural under the new OMB
delineations were assigned the wage
index of the urban labor market area
that contains the urban county in their
FY 2014 CBSA to which they are closest
(with the rural and imputed floors
applied and with the rural floor budget
neutrality adjustment applied). Any
such assignment made in FY 2015 will
continue for FYs 2016 and 2017, except
as discussed below. We continue to
believe this approach minimizes the
negative effects of the change in the
OMB delineations.
Under the policy adopted in the FY
2015 IPPS/LTCH PPS final rule, if a
hospital for FY 2014 was located in an
urban county that became rural for FY
2015 under the new OMB delineations
and such hospital sought and was
granted reclassification or redesignation
for FY 2015 or such hospital seeks and
is granted any reclassification or
redesignation for FY 2016 or FY 2017,
the hospital will permanently lose its 3year transitional assigned wage index
status, and will not be eligible to
reinstate it. We established the
transition policy to assist hospitals if
they experience a negative payment
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impact specifically due to the adoption
of the new OMB delineations in FY
2015. If a hospital chooses to forego this
transition adjustment by obtaining some
form of reclassification or redesignation,
we do not believe reinstatement of this
transition adjustment would be
appropriate. The purpose of the
transition adjustment policy is to assist
hospitals that may be negatively
impacted by the new OMB delineations
in transitioning to a wage index based
on these delineations. By obtaining a
reclassification or redesignation, we
believe that the hospital has made the
determination that the transition
adjustment is not necessary because it
has other viable options for mitigating
the impact of the transition to the new
OMB delineations.
As we did for FY 2015 (79 FR 49959),
with respect to the wage index
computation for FY 2016, we will
follow our existing policy regarding the
inclusion of a hospital’s wage index
data in the CBSA in which it is
geographically located (we refer readers
to Step 6 of the method for computing
the unadjusted wage index in the FY
2012 IPPS/LTCH PPS final rule (76 FR
51592)). Accordingly, as we began with
FY 2015, for FY 2016, the wage data of
all hospitals receiving this type of 3-year
transition adjustment will be included
in the statewide rural area in which they
are geographically located under the
new OMB labor market area
delineations. After the 3-year transition
period, beginning in FY 2018, these
formerly urban hospitals discussed
above will receive their statewide rural
wage index, absent any reclassification
or redesignation.
In addition, we established in the FY
2015 IPPS/LTCH PPS final rule (79 FR
49959) that the hospitals receiving this
3-year transition because they are in
counties that were urban under the FY
2014 CBSA definitions, but are rural
under the new OMB delineations, will
not be considered urban hospitals.
Rather, they will maintain their status as
rural hospitals for other payment
considerations. This is because our
application of a 3-year transitional wage
index for these newly rural hospitals
only applies for the purpose of
calculating the wage index under our
adoption of the new OMB delineations.
We did not establish transitions for
other IPPS payment policies that may be
impacted by our adoption of the new
OMB delineations.
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3. Transition for Hospitals Deemed
Urban Under Section 1886(d)(8)(B) of
the Act Where the Urban Area Became
Rural Under the New OMB Delineations
As discussed in the FY 2015 IPPS/
LTCH PPS final rule (79 FR 49959
through 49960), there were some
hospitals that, for FY 2014, were
geographically located in rural areas but
were deemed to be urban under section
1886(d)(8)(B) of the Act. For FY 2015,
some of these hospitals redesignated
under section 1886(d)(8)(B) of the Act
were no longer eligible for deemed
urban status under the new OMB
delineations, as discussed in detail in
section III.H.3. of the preamble of the FY
2015 IPPS/LTCH PPS final rule. Similar
to the policy implemented in the FY
2005 IPPS final rule (69 FR 49059), and
consistent with the FY 2015 policy we
established for other hospitals in
counties that were urban and became
rural under the new OMB delineations,
we finalized a policy to apply a 3-year
transition to these hospitals
redesignated to urban areas under
section 1886(d)(8)(B) of the Act for FY
2014 that are no longer deemed urban
under the new OMB delineations and
revert to being rural.
For FY 2016, we are not proposing
any changes to this policy and will
continue to the second year of the
implementation of our policy to provide
a 3-year transition adjustment to
hospitals that are deemed urban under
section 1886(d)(8)(B) of the Act under
the FY 2014 labor market area
delineations, but are considered rural
under the new OMB delineations,
assuming no other form of wage index
reclassification or redesignation is
granted. We assign these hospitals the
area wage index value of hospitals
reclassified to the urban CBSA (that is,
the attaching wage index) to which they
were redesignated in FY 2014 (with the
rural and imputed floors applied and
with the rural floor budget neutrality
adjustment applied). If the hospital
cannot be assigned the reclassified wage
index value of the CBSA to which it was
redesignated in FY 2014 because that
CBSA was split apart and no longer
exists, and some or all of its constituent
counties were added to another urban
labor market area under the new OMB
delineations, such hospitals are
assigned the wage index of the hospitals
reclassified to the urban labor market
area that contains the urban county in
their FY 2014 redesignated CBSA to
which they are closest. We assign these
hospitals the area wage index of
hospitals reclassified to a CBSA because
hospitals deemed urban under section
1886(d)(8)(B) of the Act are treated as
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Frm 00146
Fmt 4701
Sfmt 4702
reclassified under current policy, under
which such hospitals receive an area
wage index that includes wage data of
all hospitals reclassified to the area.
This wage index assignment will be
forfeited if the hospital obtains any form
of wage index reclassification or
redesignation.
4. Expiring Transition for Hospitals That
Experience a Decrease in Wage Index
Under the New OMB Delineations
In the FY 2015 IPPS/LTCH PPS final
rule (79 FR 49960 through 49962), we
stated that, while we believe that
instituting the latest OMB labor market
area delineations would create a more
accurate wage index system, we also
recognized that implementing the latest
OMB delineations may cause some
short-term instability in hospital
payments. Therefore, in addition to the
3-year transition adjustments for
hospitals being transitioned from urban
to rural status as discussed earlier, in
the FY 2015 IPPS/LTCH PPS final rule,
we established a 1-year blended wage
index for all hospitals that would
experience any decrease in their actual
payment wage index. This 1-year
blended wage index expires at the end
of FY 2015. We are not proposing any
additional transition adjustment for
hospitals that experienced a decrease in
wage index values due to the adoption
of the new OMB delineations for FY
2015 but, as discussed previously, will
continue the 3-year transition
adjustments for hospitals that changed
from urban to rural status that we
finalized in the FY 2015 IPPS/LTCH
PPS final rule. We established a longer
3-year transition adjustment for
hospitals losing urban status because
there are significantly fewer affected
urban-to-rural hospitals, and we believe
the negative impacts to a hospital
shifting from urban to rural status are
typically greater than other types of
transitions. We stated our belief that a
transition period longer than 1 year to
address other impacts of the adoption of
the new OMB delineations would
reduce the accuracy of the overall labor
market area wage index system because
far more hospitals would be affected.
The 1-year transition for all negatively
affected hospitals in FY 2015 provided
an opportunity for hospitals to evaluate
potential reclassification options, and
mitigated initial negative impacts due to
labor market assignment changes. We
continue to believe that the adoption of
the latest labor market delineations
improves the accuracy and integrity of
the hospital wage index system.
Therefore, we believe it is necessary to
allow this transition adjustment to
expire.
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30APP2
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules
5. Budget Neutrality
In the FY 2015 IPPS/LTCH PPS final
rule (79 FR 50372 through 50373), for
FY 2015, we applied the 3-year
transition and 50/50 blended wage
index adjustments in a budget neutral
manner. For FY 2016, we are proposing
to apply the 3-year transition
adjustments in a budget neutral manner.
We are proposing to make an
adjustment to the standardized amount
to ensure that the total payments,
including the effect of the transition
provisions, would equal what payments
would have been if we would not be
providing for any transitional wage
indexes under the new OMB
delineations. For a complete discussion
on the proposed budget neutrality
adjustment for FY 2016, we refer readers
to section II.A.4.b. of the Addendum to
this proposed rule.
H. Proposed Application of the
Proposed Rural, Imputed, and Frontier
Floors
tkelley on DSK3SPTVN1PROD with PROPOSALS2
1. Proposed Rural Floor
Section 4410(a) of Public Law 105–33
provides that, for discharges on or after
October 1, 1997, the area wage index
applicable to any hospital that is located
in an urban area of a State may not be
less than the area wage index applicable
to hospitals located in rural areas in that
State. This provision is referred to as the
‘‘rural floor.’’ Section 3141 of Public
Law 111–148 also requires that a
national budget neutrality adjustment be
applied in implementing the rural floor.
Based on the proposed FY 2016 wage
index associated with this proposed
rule, we estimated that 459 hospitals
would receive an increase in their FY
2016 proposed wage index due to the
application of the rural floor.
2. Proposed Imputed Floor for FY 2016
In the FY 2005 IPPS final rule (69 FR
49109 through 49111), we adopted the
‘‘imputed floor’’ policy as a temporary
3-year regulatory measure to address
concerns from hospitals in all-urban
States that have argued that they are
disadvantaged by the absence of rural
hospitals to set a wage index floor for
those States. Since its initial
implementation, we have extended the
imputed floor policy five times, the last
of which was adopted in the FY 2015
IPPS/LTCH PPS final rule and is set to
expire on September 30, 2015. (We refer
readers to further discussions of the
imputed floor in the FY 2014 and FY
2015 IPPS/LTCH PPS final rules (78 FR
50589 through 50590 and 79 FR 49969
through 49970, respectively) and to the
regulations at 42 CFR 412.64(h)(4).)
Currently, there are three all-urban
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States, Delaware, New Jersey, and
Rhode Island, with a range of wage
indexes assigned to hospitals in these
States, including through
reclassification or redesignation (we
refer readers to discussions of
geographic reclassifications and
redesignations in section III.J. of the
preamble of this proposed rule).
In computing the imputed floor for an
all-urban State under the original
methodology, which was established
beginning in FY 2005, we calculated the
ratio of the lowest-to-highest CBSA
wage index for each all-urban State as
well as the average of the ratios of
lowest-to-highest CBSA wage indexes of
those all-urban States. We then
compared the State’s own ratio to the
average ratio for all-urban States and
whichever is higher is multiplied by the
highest CBSA wage index value in the
State—the product of which established
the imputed floor for the State. As of FY
2012, there were only two all-urban
States, New Jersey and Rhode Island,
and only New Jersey benefitted under
this methodology. Under the previous
OMB labor market area delineations,
Rhode Island had only one CBSA