80 FR 24324 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Office of the Secretary
Federal Register Volume 80, Issue 83 (April 30, 2015)
Page Range
24324-24689
FR Document
2015-09245
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 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.
Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015)
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Proposed Rules]
[Pages 24324-24689]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-09245]
[[Page 24323]]
Vol. 80
Thursday,
No. 83
April 30, 2015
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 412
Office of the Secretary
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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
Federal Register / Vol. 80 , No. 83 / Thursday, April 30, 2015 /
Proposed Rules
[[Page 24324]]
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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 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
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: 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 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 http://www.regulations.gov.
Follow the instructions under the ``submit a comment'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-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 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 Hospital-
Acquired 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, PPS-Exempt Cancer Hospital Quality
Reporting Issues.
[[Page 24325]]
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: http://www.regulations.gov. Follow the search
instructions on that Web site to view public comments.
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: http://www.thefederalregister.org/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: http://www.cms.hhs.gov/Medicare/medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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, 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
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
[[Page 24326]]
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 diagnosis-related group
MS-LTC-DRG Medicare severity long-term care diagnosis-related group
MU Meaningful Use [EHR Incentive Program]
NAICS North American Industrial Classification System
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
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
[[Page 24327]]
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[supreg] PTX Drug-Eluting Peripheral Stent
(ZPTX[supreg])
d. Percutaneous Mitral Valve Repair System--Proposed Revision of
ICD-10-PCS Version 32 Logic
e. Major Cardiovascular Procedures: Zenith[supreg] 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
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 Add-On 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[supreg])
b. Zenith[supreg] Fenestrated Abdominal Aortic Aneurysm (AAA)
Endovascular Graft
c. KcentraTM
d. Argus[supreg] II Retinal Prosthesis System
e. Zilver[supreg]PTX[supreg] Drug-Eluting Peripheral Stent
f. CardioMEMSTM HF (Heart Failure) Monitoring System
g. MitraClip[supreg] System
h. Responsive Neurostimulator (RNS[supreg] System)
5. FY 2016 Applications for New Technology Add-On Payments
a. Angel Medical Guardian[supreg] Ischemia Monitoring Device
b. Blinatumomab (BLINCYTOTM)
c. Ceftazidime Avibactam (AVYCAZ)
d. DIAMONDBACK[supreg] 360 Coronary Orbital Atherectomy System
e. CRESEMBA[supreg] (Isavuconazonium)
f. Idarucizumab
g. LUTONIX[supreg] 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[supreg] 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
[[Page 24328]]
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 (Sec. Sec. 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 (Sec. 412.96)
1. Case-Mix Index (CMI)
2. Discharges
C. Indirect Medical Education (IME) Payment Adjustment for FY
2016 (Sec. 412.105)
D. Proposed FY 2016 Payment Adjustment for Medicare
Disproportionate Share Hospitals (DSHs) (Sec. 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
E. Hospital Readmissions Reduction Program: Proposed Changes for
FY 2016 Through FY 2017 (Sec. Sec. 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 30-Day, 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, Risk-Standardized 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 (Sec. 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
a. Intent To Propose in Future Rulemaking To Include Selected
Ward (Non-Intensive 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, All-Cause, 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
Caregiver-Centered 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
[[Page 24329]]
G. Proposed Changes to the Hospital-Acquired 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 (Non-Intensive 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 (Sec. 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 Capital-Related 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
B. Proposed Application of Site Neutral Payment Rate (Proposed
New Sec. 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 Sec. 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
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 (Sec. 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 30-Day, 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)
[[Page 24330]]
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 Chart-Abstracted Hospital IQR Program Data
12. Data Accuracy and Completeness Acknowledgement Requirements
for the FY 2018 Payment Determination and Subsequent Years
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 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
[[Page 24331]]
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 Capital-Related 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
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
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
capital-related 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
[[Page 24332]]
system (LTCH PPS). It also would make policy changes to programs
associated with Medicare IPPS hospitals, IPPS-excluded 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
hospital-acquired 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
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 Hospital-
Acquired Condition (HAC) Reduction Program, under which payments to
applicable hospitals are adjusted to provide an incentive to reduce
hospital-acquired conditions.
Section 1886(q) of the Act, as added by section 3025 of
the Affordable Care Act and amended by section 10309 of 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 25-percent
threshold payment adjustment policy under the LTCH PPS so that the
policy will be in effect for 9 years (except for ``grandfathered''
hospital-within-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)
[[Page 24333]]
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
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 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.
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 1-percent 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.
[[Page 24334]]
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.
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 (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.
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
[[Page 24335]]
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, 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 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 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,
[[Page 24336]]
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 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
labor-related 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 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 hospital-specific 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
[[Page 24337]]
are located in 42 CFR part 412, subparts A through M.
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; long-term
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 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 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
[[Page 24338]]
10312(a) of the Affordable Care Act by retroactively reestablishing,
and extending, the statutory moratorium on the full implementation of
the 25-percent threshold payment adjustment policy under the LTCH PPS
so that the policy will be in effect for 9 years (except for
grandfathered hospitals-within-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.
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 capital-related 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 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 hospital-acquired 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 add-on 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.
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
value-based 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
[[Page 24339]]
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.
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.
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-of-Increase 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 high-cost 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 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: http://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
[[Page 24340]]
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
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 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
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
[[Page 24341]]
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:
http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/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 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
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.
[[Page 24342]]
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 year-to-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.
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 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 cost-based 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
[[Page 24343]]
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 cost-to-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'' (http://www.rti.org/reports/cms/HHSM-500-2005-0029I/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 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 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
[[Page 24344]]
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 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 CMS-approved
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 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 Sec. 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
[[Page 24345]]
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''.
---------------------------------------------------------------------------
\1\ To view how CMS rolls up the codes to create the HCRIS SAS
files, we refer readers to http://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Cost-Reports/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).
---------------------------------------------------------------------------
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 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 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.''
---------------------------------------------------------------------------
\2\ Ibid.
---------------------------------------------------------------------------
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 5-digit codes 03020 through 03029 to
standard cost center line 53, ``Anesthesiology.'' However, determining
which other standard line
[[Page 24346]]
``Acupuncture'' and its associated 5-digit 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:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Proposed-Rule-Home-Page.html.\3\
---------------------------------------------------------------------------
\3\ Ibid.
---------------------------------------------------------------------------
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 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 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.
[[Page 24347]]
[GRAPHIC] [TIFF OMITTED] TP30AP15.000
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 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: http://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: http://www.cms.gov/manuals/downloads/Pub100_20.pdf. The current POA indicators
and their descriptors are shown in the chart below:
------------------------------------------------------------------------
Indicator Descriptor
------------------------------------------------------------------------
Y................. Indicates that the condition was present on
admission.
W................. 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.
N................. Indicates that the condition was not present on
admission.
U................. Indicates that the documentation is insufficient to
determine if the condition was present at the time
of admission.
------------------------------------------------------------------------
[[Page 24348]]
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 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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/ICD10/. Lastly, we provided information regarding the ICD-
10 MS-DRG Conversion Project on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-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: http://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: http://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: http://www.thefederalregister.org/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.
Further information of the ICD-10 rules can be found on the Web site
at: http://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.
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:
http://www.cms.hhs.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-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
[[Page 24349]]
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: http://www.cms.gov/HospitalAcqCond/01_Overview.asp and the RTI Web site at: http://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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html.
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 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html?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 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: http://www.thefederalregister.org/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: http://www.thefederalregister.org/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.
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
[[Page 24350]]
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: http://www.cms.hhs.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://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: http://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 (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 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: http://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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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
[[Page 24351]]
Definitions Manual of the ICD-10 MS-DRGs Version 31 on the ICD-10 MS-
DRG Conversion Project Web site at: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html under the ``Related Links'' section. This
ICD-10 MS-DRGs Version 32 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 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 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
[[Page 24352]]
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:
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 Code description
----------------------------------------------------------------------------------------------------------------
03LG3BZ..................................... Occlusion of intracranial artery with bioactive intraluminal
device, percutaneous approach.
03LG3DZ..................................... Occlusion of intracranial artery with intraluminal device,
percutaneous approach.
03LG4BZ..................................... Occlusion of intracranial artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LG4DZ..................................... Occlusion of intracranial artery with intraluminal device,
percutaneous endoscopic approach.
03LH3BZ..................................... Occlusion of right common carotid artery with bioactive
intraluminal device, percutaneous approach.
03LH3DZ..................................... Occlusion of right common carotid artery with intraluminal device,
percutaneous approach.
03LH4BZ..................................... Occlusion of right common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LH4DZ..................................... Occlusion of right common carotid artery with intraluminal device,
percutaneous endoscopic approach.
[[Page 24353]]
03LJ3BZ..................................... Occlusion of left common carotid artery with bioactive
intraluminal device, percutaneous approach.
03LJ3DZ..................................... Occlusion of left common carotid artery with intraluminal device,
percutaneous approach.
03LJ4BZ..................................... Occlusion of left common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LJ4DZ..................................... Occlusion of left common carotid artery with intraluminal device,
percutaneous endoscopic approach.
03LK3BZ..................................... Occlusion of right internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03LK3DZ..................................... Occlusion of right internal carotid artery with intraluminal
device, percutaneous approach.
03LK4BZ..................................... Occlusion of right internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LK4DZ..................................... Occlusion of right internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LL3BZ..................................... Occlusion of left internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03LL3DZ..................................... Occlusion of left internal carotid artery with intraluminal
device, percutaneous approach.
03LL4BZ..................................... Occlusion of left internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LL4DZ..................................... Occlusion of left internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LM3BZ..................................... Occlusion of right external carotid artery with bioactive
intraluminal device, percutaneous approach.
03LM3DZ..................................... Occlusion of right external carotid artery with intraluminal
device, percutaneous approach.
03LM4BZ..................................... Occlusion of right external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LM4DZ..................................... Occlusion of right external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LN3BZ..................................... Occlusion of left external carotid artery with bioactive
intraluminal device, percutaneous approach.
03LN3DZ..................................... Occlusion of left external carotid artery with intraluminal
device, percutaneous approach.
03LN4BZ..................................... Occlusion of left external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LN4DZ..................................... Occlusion of left external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LP3BZ..................................... Occlusion of right vertebral artery with bioactive intraluminal
device, percutaneous approach.
03LP3DZ..................................... Occlusion of right vertebral artery with intraluminal device,
percutaneous approach.
03LP4BZ..................................... Occlusion of right vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LP4DZ..................................... Occlusion of right vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03LQ3BZ..................................... Occlusion of left vertebral artery with bioactive intraluminal
device, percutaneous approach.
03LQ3DZ..................................... Occlusion of left vertebral artery with intraluminal device,
percutaneous approach.
03LQ4BZ..................................... Occlusion of left vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LQ4DZ..................................... Occlusion of left vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03LR3DZ..................................... Occlusion of face artery with intraluminal device, percutaneous
approach.
03LR4DZ..................................... Occlusion of face artery with intraluminal device, percutaneous
endoscopic approach.
03LS3DZ..................................... Occlusion of right temporal artery with intraluminal device,
percutaneous approach.
03LS4DZ..................................... Occlusion of right temporal artery with intraluminal device,
percutaneous endoscopic approach.
03LT3DZ..................................... Occlusion of left temporal artery with intraluminal device,
percutaneous approach.
03LT4DZ..................................... Occlusion of left temporal artery with intraluminal device,
percutaneous endoscopic approach.
03VG3BZ..................................... Restriction of intracranial artery with bioactive intraluminal
device, percutaneous approach.
03VG3DZ..................................... Restriction of intracranial artery with intraluminal device,
percutaneous approach.
03VG4BZ..................................... Restriction of intracranial artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VG4DZ..................................... Restriction of intracranial artery with intraluminal device,
percutaneous endoscopic approach.
03VH3BZ..................................... Restriction of right common carotid artery with bioactive
intraluminal device, percutaneous approach.
03VH3DZ..................................... Restriction of right common carotid artery with intraluminal
device, percutaneous approach.
03VH4BZ..................................... Restriction of right common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VH4DZ..................................... Restriction of right common carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VJ3BZ..................................... Restriction of left common carotid artery with bioactive
intraluminal device, percutaneous approach.
03VJ3DZ..................................... Restriction of left common carotid artery with intraluminal
device, percutaneous approach.
03VJ4BZ..................................... Restriction of left common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VJ4DZ..................................... Restriction of left common carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VK3BZ..................................... Restriction of right internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03VK3DZ..................................... Restriction of right internal carotid artery with intraluminal
device, percutaneous approach.
03VK4BZ..................................... Restriction of right internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VK4DZ..................................... Restriction of right internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VL3BZ..................................... Restriction of left internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03VL3DZ..................................... Restriction of left internal carotid artery with intraluminal
device, percutaneous approach.
03VL4BZ..................................... Restriction of left internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VL4DZ..................................... Restriction of left internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VM3BZ..................................... Restriction of right external carotid artery with bioactive
intraluminal device, percutaneous approach.
03VM3DZ..................................... Restriction of right external carotid artery with intraluminal
device, percutaneous approach.
03VM4BZ..................................... Restriction of right external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VM4DZ..................................... Restriction of right external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VN3BZ..................................... Restriction of left external carotid artery with bioactive
intraluminal device, percutaneous approach.
03VN3DZ..................................... Restriction of left external carotid artery with intraluminal
device, percutaneous approach.
03VN4BZ..................................... Restriction of left external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VN4DZ..................................... Restriction of left external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VP3BZ..................................... Restriction of right vertebral artery with bioactive intraluminal
device, percutaneous approach.
03VP3DZ..................................... Restriction of right vertebral artery with intraluminal device,
percutaneous approach.
03VP4BZ..................................... Restriction of right vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VP4DZ..................................... Restriction of right vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03VQ3BZ..................................... Restriction of left vertebral artery with bioactive intraluminal
device, percutaneous approach.
03VQ3DZ..................................... Restriction of left vertebral artery with intraluminal device,
percutaneous approach.
03VQ4BZ..................................... Restriction of left vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VQ4DZ..................................... Restriction of left vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03VR3DZ..................................... Restriction of face artery with intraluminal device, percutaneous
approach.
[[Page 24354]]
03VR4DZ..................................... Restriction of face artery with intraluminal device, percutaneous
endoscopic approach.
03VS3DZ..................................... Restriction of right temporal artery with intraluminal device,
percutaneous approach.
03VS4DZ..................................... Restriction of right temporal artery with intraluminal device,
percutaneous endoscopic approach.
03VT3DZ..................................... Restriction of left temporal artery with intraluminal device,
percutaneous approach.
03VT4DZ..................................... Restriction of left temporal artery with intraluminal device,
percutaneous endoscopic approach.
03VU3DZ..................................... Restriction of right thyroid artery with intraluminal device,
percutaneous approach.
03VU4DZ..................................... Restriction of right thyroid artery with intraluminal device,
percutaneous endoscopic approach.
03VV3DZ..................................... Restriction of left thyroid artery with intraluminal device,
percutaneous approach.
03VV4DZ..................................... Restriction of 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 020 (with MCC)--All cases................................ 1,285 16.84 $71,655
MS-DRG 021 (with CC)--All cases................................. 372 13.82 52,143
MS-DRG 022 (without CC/MCC)--All cases.......................... 98 8.28 36,998
----------------------------------------------------------------------------------------------------------------
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-part request are shown in the table
below.
Endovascular Intracranial Embolization Procedures With Principal Diagnosis of Hemorrhage
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Requested New Combined 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 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 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);
[[Page 24355]]
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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 023--All cases........................................... 5,615 10.96 $37,784
MS-DRG 023--Cases with endovascular intracranial procedure 1,510 8.88 39,666
without diagnosis of hemorrhage................................
MS-DRG 024--All cases........................................... 1,848 5.93 26,195
MS-DRG 024--Cases with endovascular intracranial procedure 867 5.80 27,975
without diagnosis of hemorrhage................................
MS-DRG 025--All cases........................................... 16,949 9.35 29,970
MS-DRG 025--Cases with endovascular intracranial procedure 650 8.52 44,082
without diagnosis of hemorrhage................................
MS-DRG 026--All cases........................................... 8,075 6.09 21,414
MS-DRG 026--Cases with endovascular intracranial procedure 778 3.07 26,594
without diagnosis of hemorrhage................................
MS-DRG 027--All cases........................................... 9,883 3.15 16,613
MS-DRG 027--Cases with endovascular intracranial procedure 1,793 1.66 22,244
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 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 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
[[Page 24356]]
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.
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 Drug-Eluting Stent with MCC or 4+ Vessels/Stents); MS-
DRG 247 (Percutaneous Cardiovascular Procedure with Drug-Eluting 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 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
Drug-Eluting Stent with MCC or 4+ Vessels/Stents);
MS-DRG 247 (Percutaneous Cardiovascular Procedure with
Drug-Eluting 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).
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
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.
[[Page 24357]]
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.52
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02U53JZ..................................... Supplement atrial septum with synthetic substitute, percutaneous
approach.
02U54JZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
027F34Z..................................... Dilation of aortic valve with drug-eluting intraluminal device,
percutaneous approach.
027F3DZ..................................... Dilation of aortic valve with intraluminal device, percutaneous
approach.
027F3ZZ..................................... Dilation of aortic valve, percutaneous approach.
027F44Z..................................... Dilation of aortic valve with drug-eluting intraluminal device,
percutaneous endoscopic approach.
027F4DZ..................................... Dilation of aortic valve with intraluminal device, percutaneous
endoscopic approach.
027F4ZZ..................................... Dilation of aortic valve, percutaneous endoscopic approach.
027G34Z..................................... Dilation of mitral valve with drug-eluting intraluminal device,
percutaneous approach.
027G3DZ..................................... Dilation of mitral valve with intraluminal device, percutaneous
approach.
027G3ZZ..................................... Dilation of mitral valve, percutaneous approach.
027G44Z..................................... Dilation of mitral valve with drug-eluting intraluminal device,
percutaneous endoscopic approach.
027G4DZ..................................... Dilation of mitral valve with intraluminal device, percutaneous
endoscopic approach.
027G4ZZ..................................... Dilation of mitral valve, percutaneous endoscopic approach.
027H34Z..................................... Dilation of pulmonary valve with drug-eluting intraluminal device,
percutaneous approach.
027H3DZ..................................... Dilation of pulmonary valve with intraluminal device, percutaneous
approach.
027H3ZZ..................................... Dilation of pulmonary valve, percutaneous approach.
027H44Z..................................... Dilation of pulmonary valve with drug-eluting intraluminal device,
percutaneous endoscopic approach.
027H4DZ..................................... Dilation of pulmonary valve with intraluminal device, percutaneous
endoscopic approach.
027H4ZZ..................................... Dilation of pulmonary valve, percutaneous endoscopic approach.
027J34Z..................................... Dilation of tricuspid valve with drug-eluting intraluminal device,
percutaneous approach.
027J3DZ..................................... Dilation of tricuspid valve with intraluminal device, percutaneous
approach.
027J3ZZ..................................... Dilation of tricuspid valve, percutaneous approach.
027J44Z..................................... Dilation of tricuspid valve with drug-eluting intraluminal device,
percutaneous endoscopic approach.
027J4DZ..................................... Dilation of tricuspid valve with intraluminal device, percutaneous
endoscopic approach.
027J4ZZ..................................... Dilation of 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 Code description
----------------------------------------------------------------------------------------------------------------
02K83ZZ..................................... Map conduction mechanism, percutaneous approach.
02K84ZZ..................................... 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
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02553ZZ..................................... Destruction of atrial septum, percutaneous approach.
02563ZZ..................................... Destruction of right atrium, percutaneous approach.
02573ZZ..................................... Destruction of left atrium, percutaneous approach.
02583ZZ..................................... Destruction of conduction mechanism, percutaneous approach.
02593ZZ..................................... Destruction of chordae tendineae, percutaneous approach.
025F3ZZ..................................... Destruction of aortic valve, percutaneous approach.
025G3ZZ..................................... Destruction of mitral valve, percutaneous approach.
025H3ZZ..................................... Destruction of pulmonary valve, percutaneous approach.
025J3ZZ..................................... Destruction of tricuspid valve, percutaneous approach.
025K3ZZ..................................... Destruction of right ventricle, percutaneous approach.
025L3ZZ..................................... Destruction of left ventricle, percutaneous approach.
[[Page 24358]]
025M3ZZ..................................... Destruction of ventricular septum, percutaneous approach.
02B53ZZ..................................... Excision of atrial septum, percutaneous approach.
02B63ZZ..................................... Excision of right atrium, percutaneous approach.
02B73ZZ..................................... Excision of left atrium, percutaneous approach.
02B83ZZ..................................... Excision of conduction mechanism, percutaneous approach.
02B93ZZ..................................... Excision of chordae tendineae, percutaneous approach.
02BF3ZZ..................................... Excision of aortic valve, percutaneous approach.
02BG3ZZ..................................... Excision of mitral valve, percutaneous approach.
02BH3ZZ..................................... Excision of pulmonary valve, percutaneous approach.
02BJ3ZZ..................................... Excision of tricuspid valve, percutaneous approach.
02BM3ZZ..................................... Excision of ventricular septum, percutaneous approach.
02T83ZZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02573ZK..................................... Destruction of left atrial appendage, percutaneous approach.
02574ZK..................................... Destruction of left atrial appendage, percutaneous endoscopic
approach.
02B73ZK..................................... Excision of left atrial appendage, percutaneous approach.
02B74ZK..................................... Excision of left atrial appendage, percutaneous endoscopic
approach.
02L73ZK..................................... Occlusion of left atrial appendage, percutaneous approach.
02L74ZK..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02L73CK..................................... Occlusion of left atrial appendage with extraluminal device,
percutaneous approach.
02L73DK..................................... Occlusion of left atrial appendage with intraluminal device,
percutaneous approach.
02L74CK..................................... Occlusion of left atrial appendage with extraluminal device,
percutaneous endoscopic approach.
02L74DK..................................... Occlusion of left atrial appendage with intraluminal device,
percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-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
----------------------------------------------------------------------------------------------------------------
Average
MS-DRG Number of length of Average costs
cases stay
----------------------------------------------------------------------------------------------------------------
MS-DRG 246--All cases........................................... 30,617 5.52 $23,855
MS-DRG 246--Cases with procedure codes 35.52, 35.96, 35.97, 244 9.69 $34.099
37.26, 37.27, 37.34, 37.36, and 37.90..........................
MS-DRG 247--All cases........................................... 79,639 2.69 $15,671
MS-DRG 247--Cases with procedure codes 35.52, 35.96, 35.97, 260 5.20 $25,797
37.26, 37.27, 37.34, 37.36, and 37.90..........................
MS-DRG 248--All cases........................................... 9,310 6.37 $22,504
MS-DRG 248 -Cases with procedure codes 35.52, 35.96, 35.97, 125 10.76 $33,521
37.26, 37.27, 37.34, 37.36, and 37.90..........................
MS-DRG 249--All cases........................................... 16,273 3.08 $14,066
MS-DRG 249--Cases with procedure codes 35.52, 35.96, 35.97, 81 5.12 $23,710
37.26, 37.27, 37.34, 37.36, and 37.90..........................
MS-DRG 250--All cases........................................... 9,275 7.07 $22,902
[[Page 24359]]
MS-DRG 250- Cases with procedure codes 35.52, 35.96, 35.97, 5,826 7.90 $24,841
37.26, 37.27, 37.34, 37.36, and 37.90..........................
MS-DRG 251--All cases........................................... 20,945 3.25 $15,757
MS-DRG 251--Cases with procedure codes 35.52, 35.96, 35.97, 14,436 3.39 $17,290
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.
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
----------------------------------------------------------------------------------------------------------------
Average
MS-DRG Number of length of Average costs
cases stay
----------------------------------------------------------------------------------------------------------------
MS-DRGs 246 through 251--Cases with procedure codes 35.52, 20,972 4.79 $19,810
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, 145,087 3.62 17,532
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
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
----------------------------------------------------------------------------------------------------------------
Average
MS-DRG Number of length of Average costs
cases stay
----------------------------------------------------------------------------------------------------------------
Proposed MS-DRG 273 with MCC.................................... 6,195 8.03 $25,380
Proposed MS-DRG 274 without MCC................................. 14,777 3.44 17,475
----------------------------------------------------------------------------------------------------------------
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 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 codes to the proposed new MS-DRGs
273 and 274.
As mentioned earlier in this section, we received a similar request
in
[[Page 24360]]
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 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.
----------------------------------------------------------------------------------------------------------------
Average
Percutaneous cardiovascular MS-DRG with and without stent Number of length of Average costs
procedures by suggested severity level cases stay
----------------------------------------------------------------------------------------------------------------
Suggested MS-DRG 246 with MCC................................... 30,617 5.52 $23,855
Suggested MS-DRG 246 with CC.................................... 45,313 2.96 16,233
Suggested MS-DRG 246 without CC/MCC............................. 34,326 2.33 14,928
Suggested MS-DRG 248 with MCC................................... 9,310 6.37 22,504
Suggested MS-DRG 248 with CC.................................... 9,510 3.49 14,798
Suggested MS-DRG 248 without CC/MCC............................. 6,763 2.51 13,037
Suggested MS-DRG 250 with MCC................................... 9,275 7.07 22,903
Suggested MS-DRG 250 with CC.................................... 11,653 3.80 16,113
Suggested MS-DRG 250 without CC/MCC............................. 9,292 2.56 15,310
----------------------------------------------------------------------------------------------------------------
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, 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 246--All cases........................................... 30,617 5.52 $23,855
MS-DRG 247--All cases........................................... 79,639 2.69 15,671
MS-DRG 248--All cases........................................... 9,310 6.37 22,504
MS-DRG 249--All cases........................................... 16,273 3.08 14,066
MS-DRG 250--All cases........................................... 9,275 7.07 22,903
MS-DRG 251--All cases........................................... 20,945 3.25 15,757
----------------------------------------------------------------------------------------------------------------
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 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 Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 245--All cases........................................ 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 Average
AICD generator procedures by suggested severity level cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
Suggested MS-DRG 245 with MCC................................... 542 8.15 $40,004
[[Page 24361]]
Suggested MS-DRG 245 with CC.................................... 939 4.51 32,237
Suggested MS-DRG 245 without CC/MCC............................. 218 3.12 28,907
----------------------------------------------------------------------------------------------------------------
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 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
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases 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 3-way 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 Average
MS-DRG by suggested severity level cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 245 with MCC............................................. 44 7.32 $39,536
MS-DRG 245 with CC.............................................. 1,118 4.26 31,786
MS-DRG 245 without CC/MCC....................................... 288 3.10 29,383
----------------------------------------------------------------------------------------------------------------
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.
c. Zilver[supreg] PTX Drug-Eluting Peripheral Stent (Zilver[supreg]
PTX[supreg])
Zilver[supreg] PTX Drug-Eluting Peripheral Stent (Zilver[supreg]
PTX[supreg]) was approved for new technology add-on payments in FY 2014
(78 FR 50583 through 50585). Cases involving the Zilver[supreg]
PTX[supreg] that are eligible for new technology add-on payments are
identified by ICD-9-CM procedure code 00.60 (Insertion of drug-eluting
stent(s) of superficial femoral artery).
We received a request from the manufacturer for an extension of new
technology add-on payments for Zilver[supreg] PTX[supreg] 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 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 drug-eluting stents used in
the peripheral (noncoronary) vasculature. The third option was to
assign all Zilver[supreg] PTX[supreg] 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);
[[Page 24362]]
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 Average length
MS-DRGs cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 252--All cases........................................... 30,696 7.89 $23,935
MS-DRG 252--Cases with procedure code 00.60..................... 133 9.08 32,623
MS-DRG 253--All cases........................................... 34,746 5.68 19,030
MS-DRG 253--Cases with procedure code 00.60..................... 353 4.99 25,396
MS-DRG 254--All cases........................................... 15,394 2.99 12,629
MS-DRG 254--Cases with procedure code 00.60..................... 115 2.62 21,461
----------------------------------------------------------------------------------------------------------------
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
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).
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 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
Drug-Eluting Stent with MCC or 4+ Vessels/Stents);
MS DRG 247 (Percutaneous Cardiovascular Procedure with
Drug-Eluting 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 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[supreg] Fenestrated
Abdominal Aortic Aneurysm (AAA) Graft
The new technology add-on payment for the Zenith[supreg]
Fenestrated Abdominal Aortic Aneurysm (AAA) Graft (Zenith[supreg] F.
Graft) will end on September 30, 2015. Cases involving the
Zenith[supreg] 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[supreg] F. Graft, we refer readers to the
[[Page 24363]]
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 Code description
----------------------------------------------------------------------------------------------------------------
04U03JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
approach.
04U04JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
endoscopic approach.
04V03DZ..................................... Restriction of abdominal aorta with intraluminal device,
percutaneous approach.
04V04DZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
04793DZ..................................... Dilation of right renal artery with intraluminal device,
percutaneous approach.
04794DZ..................................... Dilation of right renal artery with intraluminal device,
percutaneous endoscopic approach.
047A3DZ..................................... Dilation of left renal artery with intraluminal device,
percutaneous approach.
047A4DZ..................................... Dilation of left renal artery with intraluminal device,
percutaneous endoscopic approach.
04753DZ..................................... Dilation of superior mesenteric artery with intraluminal device,
percutaneous approach.
04754DZ..................................... Dilation of superior mesenteric artery with intraluminal device,
percutaneous endoscopic approach.
04V03DZ..................................... Restriction of abdominal aorta with intraluminal device,
percutaneous approach.
04V04DZ..................................... 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 237--All cases........................................... 18,340 9.46 $36,355
MS-DRG 237--Cases with procedure code 39.78..................... 332 8.46 51,397
MS-DRG 238--All cases........................................... 32,227 3.72 25,087
MS-DRG 238--Cases with procedure code 39.78..................... 1,927 2.52 31,739
----------------------------------------------------------------------------------------------------------------
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 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[supreg] 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, 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
[[Page 24364]]
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[supreg] 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[supreg] 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 237--All cases........................................... 18,340 9.46 $36,355
MS-DRG 237--Cases with procedure codes 39.71 and 39.78.......... 2,425 8.34 47,363
MS-DRG 238--All cases........................................... 32,227 3.72 25,087
MS-DRG 238--Cases with procedure codes 39.71 and 39.78.......... 16,502 2.27 28,998
----------------------------------------------------------------------------------------------------------------
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);
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:
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.41
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02UA0JZ..................................... Supplement heart with synthetic substitute, open approach.
02UA3JZ..................................... Supplement heart with synthetic substitute, percutaneous approach.
02UA4JZ..................................... Supplement heart with synthetic substitute, percutaneous
endoscopic approach.
----------------------------------------------------------------------------------------------------------------
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) for this proposed rule
(which
[[Page 24365]]
is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. The table includes the MDC 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.55
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02PA0QZ..................................... Removal of implantable heart assist system from heart, open
approach.
02PA3QZ..................................... Removal of implantable heart assist system from heart,
percutaneous approach.
02PA4QZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02PA0RZ..................................... Removal of external heart assist system from heart, open approach.
02PA3RZ..................................... Removal of external heart assist system from heart, percutaneous
approach.
02PA4RZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02CW0ZZ..................................... Extirpation of matter from thoracic aorta, open approach.
02CW3ZZ..................................... Extirpation of matter from thoracic aorta, percutaneous approach.
02CW4ZZ..................................... Extirpation of matter from thoracic aorta, percutaneous endoscopic
approach.
04C00ZZ..................................... Extirpation of matter from abdominal aorta, open approach.
04C03ZZ..................................... Extirpation of matter from abdominal aorta, percutaneous approach.
04C04ZZ..................................... Extirpation of matter from abdominal aorta, percutaneous
endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.14
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02CW0ZZ..................................... Extirpation of matter from thoracic aorta, open approach.
02CW3ZZ..................................... Extirpation of matter from thoracic aorta, percutaneous approach.
02CW4ZZ..................................... Extirpation of matter from thoracic aorta, percutaneous endoscopic
approach.
04C00ZZ..................................... Extirpation of matter from abdominal aorta, open approach.
04C03ZZ..................................... Extirpation of matter from abdominal aorta, percutaneous approach.
04C04ZZ..................................... Extirpation of matter from abdominal aorta, percutaneous
endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.34
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02BW0ZZ..................................... Excision of thoracic aorta, open approach.
02BW4ZZ..................................... Excision of thoracic aorta, percutaneous endoscopic approach.
04B00ZZ..................................... Excision of abdominal aorta, open approach.
04B04ZZ..................................... Excision of abdominal aorta, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.44
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04R007Z..................................... Replacement of abdominal aorta with autologous tissue substitute,
open approach.
04R00JZ..................................... Replacement of abdominal aorta with synthetic substitute, open
approach.
[[Page 24366]]
04R00KZ..................................... Replacement of abdominal aorta with nonautologous tissue
substitute, open approach.
04R047Z..................................... Replacement of abdominal aorta with autologous tissue substitute,
percutaneous endoscopic approach.
04R04JZ..................................... Replacement of abdominal aorta with synthetic substitute,
percutaneous endoscopic approach.
04R04KZ..................................... Replacement of abdominal aorta with nonautologous tissue
substitute, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.64
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04500ZZ..................................... Destruction of abdominal aorta, open approach.
04503ZZ..................................... Destruction of abdominal aorta, percutaneous approach.
04504ZZ..................................... Destruction of abdominal aorta, percutaneous endoscopic approach.
04B00ZZ..................................... Excision of abdominal aorta, open approach.
04B03ZZ..................................... Excision of abdominal aorta, percutaneous approach.
04B04ZZ..................................... Excision of abdominal aorta, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.84
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04L00CZ..................................... Occlusion of abdominal aorta with extraluminal device, open
approach.
04L00DZ..................................... Occlusion of abdominal aorta with intraluminal device, open
approach.
04L00ZZ..................................... Occlusion of abdominal aorta, open approach.
04L03CZ..................................... Occlusion of abdominal aorta with extraluminal device,
percutaneous approach.
04L03DZ..................................... Occlusion of abdominal aorta with intraluminal device,
percutaneous approach.
04L03ZZ..................................... Occlusion of abdominal aorta, percutaneous approach.
04L04CZ..................................... Occlusion of abdominal aorta with extraluminal device,
percutaneous endoscopic approach.
04L04DZ..................................... Occlusion of abdominal aorta with intraluminal device,
percutaneous endoscopic approach.
04L04ZZ..................................... Occlusion of abdominal aorta, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.24
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
0410093..................................... Bypass abdominal aorta to right renal artery with autologous
venous tissue, open approach.
0410094..................................... Bypass abdominal aorta to left renal artery with autologous venous
tissue, open approach.
0410095..................................... Bypass abdominal aorta to bilateral renal artery with autologous
venous tissue, open approach.
04100A3..................................... Bypass abdominal aorta to right renal artery with autologous
arterial tissue, open approach.
04100A4..................................... Bypass abdominal aorta to left renal artery with autologous
arterial tissue, open approach.
04100A5..................................... Bypass abdominal aorta to bilateral renal artery with autologous
arterial tissue, open approach.
04100J3..................................... Bypass abdominal aorta to right renal artery with synthetic
substitute, open approach.
04100J4..................................... Bypass abdominal aorta to left renal artery with synthetic
substitute, open approach.
04100J5..................................... Bypass abdominal aorta to bilateral renal artery with synthetic
substitute, open approach.
04100K3..................................... Bypass abdominal aorta to right renal artery with nonautologous
tissue substitute, open approach.
04100K4..................................... Bypass abdominal aorta to left renal artery with nonautologous
tissue substitute, open approach.
04100K5..................................... Bypass abdominal aorta to bilateral renal artery with
nonautologous tissue substitute, open approach.
04100Z3..................................... Bypass abdominal aorta to right renal artery, open approach.
04100Z4..................................... Bypass abdominal aorta to left renal artery, open approach.
04100Z5..................................... Bypass abdominal aorta to bilateral renal artery, open approach.
0410493..................................... Bypass abdominal aorta to right renal artery with autologous
venous tissue, percutaneous endoscopic approach.
0410494..................................... Bypass abdominal aorta to left renal artery with autologous venous
tissue, percutaneous endoscopic approach.
0410495..................................... Bypass abdominal aorta to bilateral renal artery with autologous
venous tissue, percutaneous endoscopic approach.
04104A3..................................... Bypass abdominal aorta to right renal artery with autologous
arterial tissue, percutaneous endoscopic approach.
04104A4..................................... Bypass abdominal aorta to left renal artery with autologous
arterial tissue, percutaneous endoscopic approach.
04104A5..................................... Bypass abdominal aorta to bilateral renal artery with autologous
arterial tissue, percutaneous endoscopic approach.
04104J3..................................... Bypass abdominal aorta to right renal artery with synthetic
substitute, percutaneous endoscopic approach.
04104J4..................................... Bypass abdominal aorta to left renal artery with synthetic
substitute, percutaneous endoscopic approach.
04104J5..................................... Bypass abdominal aorta to bilateral renal artery with synthetic
substitute, percutaneous endoscopic approach.
04104K3..................................... Bypass abdominal aorta to right renal artery with nonautologous
tissue substitute, percutaneous endoscopic approach.
04104K4..................................... Bypass abdominal aorta to left renal artery with nonautologous
tissue substitute, percutaneous endoscopic approach.
04104K5..................................... Bypass abdominal aorta to bilateral renal artery with
nonautologous tissue substitute, percutaneous endoscopic
approach.
04104Z3..................................... Bypass abdominal aorta to right renal artery, percutaneous
endoscopic approach.
04104Z4..................................... Bypass abdominal aorta to left renal artery, percutaneous
endoscopic approach.
04104Z5..................................... Bypass abdominal aorta to bilateral renal artery, percutaneous
endoscopic approach.
----------------------------------------------------------------------------------------------------------------
[[Page 24367]]
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.71
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04U03JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
approach.
04U04JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
endoscopic approach.
04V03DZ..................................... Restriction of abdominal aorta with intraluminal device,
percutaneous approach.
04V04DZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
04793DZ..................................... Dilation of right renal artery with intraluminal device,
percutaneous approach.
04794DZ..................................... Dilation of right renal artery with intraluminal device,
percutaneous endoscopic approach.
047A3DZ..................................... Dilation of left renal artery with intraluminal device,
percutaneous approach.
047A4DZ..................................... Dilation of left renal artery with intraluminal device,
percutaneous endoscopic approach.
04753DZ..................................... Dilation of superior mesenteric artery with intraluminal device,
percutaneous approach.
04754DZ..................................... Dilation of superior mesenteric artery with intraluminal device,
percutaneous endoscopic approach.
04U03JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
approach.
04U04JZ..................................... Supplement abdominal aorta with synthetic substitute, percutaneous
endoscopic approach.
04V03DZ..................................... Restriction of abdominal aorta with intraluminal device,
percutaneous approach.
04V04DZ..................................... 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
----------------------------------------------------------------------------------------------------------------
ICD-9-CM procedure code Code description
----------------------------------------------------------------------------------------------------------------
35.00....................................... Closed heart valvotomy, unspecified valve.
35.01....................................... Closed heart valvotomy, aortic valve.
35.02....................................... Closed heart valvotomy, mitral valve.
35.03....................................... Closed heart valvotomy, pulmonary valve.
35.04....................................... Closed heart valvotomy, tricuspid valve.
37.12....................................... Pericardiotomy.
37.24....................................... Biopsy of pericardium.
37.31....................................... Pericardiectomy.
37.61....................................... Implant of pulsation balloon.
37.67....................................... Implantation of cardiomyostimulation system.
37.91....................................... Open chest cardiac massage.
37.99....................................... Other operations on heart and pericardium.
38.05....................................... Incision of vessel, other thoracic vessels.
38.06....................................... Incision of vessel, abdominal arteries.
38.07....................................... Incision of vessel, abdominal veins.
38.15....................................... Endarterectomy, other thoracic vessels.
38.16....................................... Endarterectomy, abdominal arteries.
38.35....................................... Resection of vessel with anastomosis, other thoracic vessels.
38.36....................................... Resection of vessel with anastomosis, abdominal arteries.
38.37....................................... Resection of vessel with anastomosis, abdominal veins.
38.46....................................... Resection of vessel with replacement, abdominal arteries.
38.47....................................... Resection of vessel with replacement, abdominal veins.
38.55....................................... Ligation and stripping of varicose veins, other thoracic vessels.
38.65....................................... Other excision of vessels, thoracic vessels.
38.66....................................... Other excision of vessels, abdominal arteries.
38.67....................................... Other excision of vessels, abdominal veins.
38.85....................................... Other surgical occlusion of vessels, thoracic vessels.
38.86....................................... Other surgical occlusion of vessels, abdominal arteries.
38.87....................................... Other surgical occlusion of vessels, abdominal veins.
39.0........................................ Systemic to pulmonary artery shunt.
39.1........................................ Intra-abdominal venous shunt.
39.21....................................... Caval-pulmonary artery anastomosis.
39.22....................................... Aorta-subclavian-carotid bypass.
39.23....................................... Other intrathoracic vascular shunt or bypass.
39.25....................................... Aorta-iliac-femoral bypass.
39.26....................................... Other intra-abdominal vascular shunt or bypass.
39.52....................................... Other repair of aneurysm.
39.54....................................... Re-entry operation (aorta).
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.
[[Page 24368]]
39.76....................................... Endovascular embolization or occlusion of vessel(s) of head or
neck using bioactive coils.
39.79....................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02NF3ZZ..................................... Release aortic valve, percutaneous approach.
02NF4ZZ..................................... Release aortic valve, percutaneous endoscopic approach.
02NG3ZZ..................................... Release mitral valve, percutaneous approach.
02NG4ZZ..................................... Release mitral valve, percutaneous endoscopic approach.
02NH3ZZ..................................... Release pulmonary valve, percutaneous approach.
02NH4ZZ..................................... Release pulmonary valve, percutaneous endoscopic approach.
02NJ3ZZ..................................... Release tricuspid valve, percutaneous approach.
02NJ4ZZ..................................... Release tricuspid valve, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.01
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02CF3ZZ..................................... Extirpation of matter from aortic valve, percutaneous approach.
02CF4ZZ..................................... Extirpation of matter from aortic valve, percutaneous endoscopic
approach.
02NF3ZZ..................................... Release aortic valve, percutaneous approach.
02NF4ZZ..................................... Release aortic valve, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translation for ICD-9-CM Procedure Code 35.02
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02CG3ZZ..................................... Extirpation of matter from mitral valve, percutaneous approach.
02CG4ZZ..................................... Extirpation of matter from mitral valve, percutaneous endoscopic
approach.
02NG3ZZ..................................... Release mitral valve, percutaneous approach.
02NG4ZZ..................................... Release mitral valve, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.03
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02CH3ZZ..................................... Extirpation of matter from pulmonary valve, percutaneous approach.
02CH4ZZ..................................... Extirpation of matter from pulmonary valve, percutaneous
endoscopic approach.
02NH3ZZ..................................... Release Pulmonary Valve, Percutaneous Approach.
02NH4ZZ..................................... Release Pulmonary Valve, Percutaneous Endoscopic Approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 35.04
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Description
----------------------------------------------------------------------------------------------------------------
02CJ3ZZ..................................... Extirpation of matter from tricuspid valve, percutaneous approach.
02CJ4ZZ..................................... Extirpation of matter from tricuspid valve, percutaneous
endoscopic approach.
02NJ3ZZ..................................... Release tricuspid valve, percutaneous approach.
02NJ4ZZ..................................... Release tricuspid valve, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.12
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02CN0ZZ..................................... Extirpation of matter from pericardium, open approach.
02CN3ZZ..................................... Extirpation of matter from pericardium, percutaneous approach.
[[Page 24369]]
02CN4ZZ..................................... Extirpation of matter from pericardium, percutaneous endoscopic
approach.
02HN00Z..................................... Insertion of pressure sensor monitoring device into pericardium,
open approach.
02HN02Z..................................... Insertion of monitoring device into pericardium, open approach.
02HN30Z..................................... Insertion of pressure sensor monitoring device into pericardium,
percutaneous approach.
02HN32Z..................................... Insertion of monitoring device into pericardium, percutaneous
approach.
02HN40Z..................................... Insertion of pressure sensor monitoring device into pericardium,
percutaneous endoscopic approach.
02HN42Z..................................... Insertion of monitoring device into pericardium, percutaneous
endoscopic approach.
02NN0ZZ..................................... Release pericardium, open approach.
02NN3ZZ..................................... Release pericardium, percutaneous approach.
02NN4ZZ..................................... Release pericardium, percutaneous endoscopic approach.
0W9D00Z..................................... Drainage of pericardial cavity with drainage device, open
approach.
0W9D0ZX..................................... Drainage of pericardial cavity, open approach, diagnostic.
0W9D0ZZ..................................... Drainage of pericardial cavity, open approach.
0WCD0ZZ..................................... Extirpation of matter from pericardial cavity, open approach.
0WCD3ZZ..................................... Extirpation of matter from pericardial cavity, percutaneous
approach.
0WCD4ZZ..................................... Extirpation of matter from pericardial cavity, percutaneous
endoscopic approach.
0WHD03Z..................................... Insertion of infusion device into pericardial cavity, open
approach.
0WHD0YZ..................................... Insertion of other device into pericardial cavity, open approach.
0WHD33Z..................................... Insertion of infusion device into pericardial cavity, percutaneous
approach.
0WHD3YZ..................................... Insertion of other device into pericardial cavity, percutaneous
approach.
0WHD43Z..................................... Insertion of infusion device into pericardial cavity, percutaneous
endoscopic approach.
0WHD4YZ..................................... Insertion of other device into pericardial cavity, percutaneous
endoscopic approach.
0WPD00Z..................................... Removal of drainage device from pericardial cavity, open approach.
0WPD01Z..................................... Removal of radioactive element from pericardial cavity, open
approach.
0WPD03Z..................................... Removal of infusion device from pericardial cavity, open approach.
0WPD0YZ..................................... Removal of other device from pericardial cavity, open approach.
0WPD30Z..................................... Removal of drainage device from pericardial cavity, percutaneous
approach.
0WPD31Z..................................... Removal of radioactive element from pericardial cavity,
percutaneous approach.
0WPD33Z..................................... Removal of infusion device from pericardial cavity, percutaneous
approach.
0WPD3YZ..................................... Removal of other device from pericardial cavity, percutaneous
approach.
0WPD40Z..................................... Removal of drainage device from pericardial cavity, percutaneous
endoscopic approach.
0WPD41Z..................................... Removal of radioactive element from pericardial cavity,
percutaneous endoscopic approach.
0WPD43Z..................................... Removal of infusion device from pericardial cavity, percutaneous
endoscopic approach.
0WPD4YZ..................................... Removal of other device from pericardial cavity, percutaneous
endoscopic approach.
0WWD00Z..................................... Revision of drainage device in pericardial cavity, open approach.
0WWD01Z..................................... Revision of radioactive element in pericardial cavity, open
approach.
0WWD03Z..................................... Revision of infusion device in pericardial cavity, open approach.
0WWD0YZ..................................... Revision of other device in pericardial cavity, open approach.
0WWD30Z..................................... Revision of drainage device in pericardial cavity, percutaneous
approach.
0WWD31Z..................................... Revision of radioactive element in pericardial cavity,
percutaneous approach.
0WWD33Z..................................... Revision of infusion device in pericardial cavity, percutaneous
approach.
0WWD3YZ..................................... Revision of other device in pericardial cavity, percutaneous
approach.
0WWD40Z..................................... Revision of drainage device in pericardial cavity, percutaneous
endoscopic approach.
0WWD41Z..................................... Revision of radioactive element in pericardial cavity,
percutaneous endoscopic approach.
0WWD43Z..................................... Revision of infusion device in pericardial cavity, percutaneous
endoscopic approach.
0WWD4YZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02BN0ZX..................................... Excision of pericardium, open approach, diagnostic
02BN3ZX..................................... Excision of pericardium, percutaneous approach, diagnostic
02BN4ZX..................................... Excision of pericardium, percutaneous endoscopic approach,
diagnostic
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.31
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
025N0ZZ..................................... Destruction of pericardium, open approach.
025N3ZZ..................................... Destruction of pericardium, percutaneous approach.
025N4ZZ..................................... Destruction of pericardium, percutaneous endoscopic approach.
02BN0ZZ..................................... Excision of pericardium, open approach.
02BN3ZZ..................................... Excision of pericardium, percutaneous approach.
02BN4ZZ..................................... Excision of pericardium, percutaneous endoscopic approach.
02TN0ZZ..................................... Resection of pericardium, open approach.
02TN3ZZ..................................... Resection of pericardium, percutaneous approach.
02TN4ZZ..................................... Resection of pericardium, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
[[Page 24370]]
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.61
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
5A02110..................................... Assistance with cardiac output using balloon pump, intermittent.
5A02210..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02QA0ZZ..................................... Repair heart, open approach.
02QA3ZZ..................................... Repair heart, percutaneous approach.
02QA4ZZ..................................... Repair heart, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.91
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02QA0ZZ..................................... Repair heart, open approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 37.99
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02880ZZ..................................... Division of conduction mechanism, open approach.
02883ZZ..................................... Division of conduction mechanism, percutaneous approach.
02884ZZ..................................... 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: http://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
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04C10ZZ..................................... Extirpation of matter from celiac artery, open approach.
04C13ZZ..................................... Extirpation of matter from celiac artery, percutaneous approach.
04C14ZZ..................................... Extirpation of matter from celiac artery, percutaneous endoscopic
approach.
04C20ZZ..................................... Extirpation of matter from gastric artery, open approach.
04C23ZZ..................................... Extirpation of matter from gastric artery, percutaneous approach.
04C24ZZ..................................... Extirpation of matter from gastric artery, percutaneous endoscopic
approach.
04C30ZZ..................................... Extirpation of matter from hepatic artery, open approach.
04C33ZZ..................................... Extirpation of matter from hepatic artery, percutaneous approach.
04C34ZZ..................................... Extirpation of matter from hepatic artery, percutaneous endoscopic
approach.
04C40ZZ..................................... Extirpation of matter from splenic artery, open approach.
04C43ZZ..................................... Extirpation of matter from splenic artery, percutaneous approach.
04C44ZZ..................................... Extirpation of matter from splenic artery, percutaneous endoscopic
approach.
04C50ZZ..................................... Extirpation of matter from superior mesenteric artery, open
approach.
04C53ZZ..................................... Extirpation of matter from superior mesenteric artery,
percutaneous approach.
04C54ZZ..................................... Extirpation of matter from superior mesenteric artery,
percutaneous endoscopic approach.
04C60ZZ..................................... Extirpation of matter from right colic artery, open approach.
04C63ZZ..................................... Extirpation of matter from right colic artery, percutaneous
approach.
04C64ZZ..................................... Extirpation of matter from right colic artery, percutaneous
endoscopic approach.
04C70ZZ..................................... Extirpation of matter from left colic artery, open approach.
04C73ZZ..................................... Extirpation of matter from left colic artery, percutaneous
approach.
04C74ZZ..................................... Extirpation of matter from left colic artery, percutaneous
endoscopic approach.
04C80ZZ..................................... Extirpation of matter from middle colic artery, open approach.
04C83ZZ..................................... Extirpation of matter from middle colic artery, percutaneous
approach.
04C84ZZ..................................... Extirpation of matter from middle colic artery, percutaneous
endoscopic approach.
04C90ZZ..................................... Extirpation of matter from right renal artery, open approach.
04C93ZZ..................................... Extirpation of matter from right renal artery, percutaneous
approach.
04C94ZZ..................................... Extirpation of matter from right renal artery, percutaneous
endoscopic approach.
04CA0ZZ..................................... Extirpation of matter from left renal artery, open approach.
04CA3ZZ..................................... Extirpation of matter from left renal artery, percutaneous
approach.
04CA4ZZ..................................... Extirpation of matter from left renal artery, percutaneous
endoscopic approach.
[[Page 24371]]
04CB0ZZ..................................... Extirpation of matter from inferior mesenteric artery, open
approach.
04CB3ZZ..................................... Extirpation of matter from inferior mesenteric artery,
percutaneous approach.
04CB4ZZ..................................... Extirpation of matter from inferior mesenteric artery,
percutaneous endoscopic approach.
04CC0ZZ..................................... Extirpation of matter from right common iliac artery, open
approach.
04CC3ZZ..................................... Extirpation of matter from right common iliac artery, percutaneous
approach.
04CC4ZZ..................................... Extirpation of matter from right common iliac artery, percutaneous
endoscopic approach.
04CD0ZZ..................................... Extirpation of matter from left common iliac artery, open
approach.
04CD3ZZ..................................... Extirpation of matter from left common iliac artery, percutaneous
approach.
04CD4ZZ..................................... Extirpation of matter from left common iliac artery, percutaneous
endoscopic approach.
04CE0ZZ..................................... Extirpation of matter from right internal iliac artery, open
approach.
04CE3ZZ..................................... Extirpation of matter from right internal iliac artery,
percutaneous approach.
04CE4ZZ..................................... Extirpation of matter from right internal iliac artery,
percutaneous endoscopic approach.
04CF0ZZ..................................... Extirpation of matter from left internal iliac artery, open
approach.
04CF3ZZ..................................... Extirpation of matter from left internal iliac artery,
percutaneous approach.
04CF4ZZ..................................... Extirpation of matter from left internal iliac artery,
percutaneous endoscopic approach.
04CH0ZZ..................................... Extirpation of matter from right external iliac artery, open
approach.
04CH3ZZ..................................... Extirpation of matter from right external iliac artery,
percutaneous approach.
04CH4ZZ..................................... Extirpation of matter from right external iliac artery,
percutaneous endoscopic approach.
04CJ0ZZ..................................... Extirpation of matter from left external iliac artery, open
approach.
04CJ3ZZ..................................... Extirpation of matter from left external iliac artery,
percutaneous approach.
04CJ4ZZ..................................... Extirpation of matter from left external iliac artery,
percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.07
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
06C00ZZ..................................... Extirpation of matter from inferior vena cava, open approach.
06C03ZZ..................................... Extirpation of matter from inferior vena cava, percutaneous
approach.
06C04ZZ..................................... Extirpation of matter from inferior vena vava, percutaneous
endoscopic approach.
06C10ZZ..................................... Extirpation of matter from splenic vein, open approach.
06C13ZZ..................................... Extirpation of matter from splenic vein, percutaneous approach.
06C14ZZ..................................... Extirpation of matter from splenic vein, percutaneous endoscopic
approach.
06C20ZZ..................................... Extirpation of matter from gastric vein, open approach.
06C23ZZ..................................... Extirpation of matter from gastric vein, percutaneous approach.
06C24ZZ..................................... Extirpation of matter from gastric vein, percutaneous endoscopic
approach.
06C40ZZ..................................... Extirpation of matter from hepatic vein, open approach.
06C43ZZ..................................... Extirpation of matter from hepatic vein, percutaneous approach.
06C44ZZ..................................... Extirpation of matter from hepatic vein, percutaneous endoscopic
approach.
06C50ZZ..................................... Extirpation of matter from superior mesenteric vein, open
approach.
06C53ZZ..................................... Extirpation of matter from superior mesenteric vein, percutaneous
approach.
06C54ZZ..................................... Extirpation of matter from superior mesenteric vein, percutaneous
endoscopic approach.
06C60ZZ..................................... Extirpation of matter from inferior mesenteric vein, open
approach.
06C63ZZ..................................... Extirpation of matter from inferior mesenteric vein, percutaneous
approach.
06C64ZZ..................................... Extirpation of matter from inferior mesenteric vein, percutaneous
endoscopic approach.
06C70ZZ..................................... Extirpation of matter from colic vein, open approach.
06C73ZZ..................................... Extirpation of matter from colic vein, percutaneous approach.
06C74ZZ..................................... Extirpation of matter from colic vein, percutaneous endoscopic
approach.
06C80ZZ..................................... Extirpation of matter from portal vein, open approach.
06C83ZZ..................................... Extirpation of matter from portal vein, percutaneous approach.
06C84ZZ..................................... Extirpation of matter from portal vein, percutaneous endoscopic
approach.
06C90ZZ..................................... Extirpation of matter from right renal vein, open approach.
06C93ZZ..................................... Extirpation of matter from right renal vein, percutaneous
approach.
06C94ZZ..................................... Extirpation of matter from right renal vein, percutaneous
endoscopic approach.
06CB0ZZ..................................... Extirpation of matter from left renal vein, open approach.
06CB3ZZ..................................... Extirpation of matter from left renal vein, percutaneous approach.
06CB4ZZ..................................... Extirpation of matter from left renal vein, percutaneous
endoscopic approach.
06CC0ZZ..................................... Extirpation of matter from right common iliac vein, open approach.
06CC3ZZ..................................... Extirpation of matter from right common iliac vein, percutaneous
approach.
06CC4ZZ..................................... Extirpation of matter from right common iliac vein, percutaneous
endoscopic approach.
06CD0ZZ..................................... Extirpation of matter from left common iliac vein, open approach.
06CD3ZZ..................................... Extirpation of matter from left common iliac vein, percutaneous
approach.
06CD4ZZ..................................... Extirpation of matter from left common iliac vein, percutaneous
endoscopic approach.
06CF0ZZ..................................... Extirpation of matter from right external iliac vein, open
approach.
06CF3ZZ..................................... Extirpation of matter from right external iliac vein, percutaneous
approach.
06CF4ZZ..................................... Extirpation of matter from right external iliac vein, percutaneous
endoscopic approach.
06CG0ZZ..................................... Extirpation of matter from left external iliac vein, open
approach.
06CG3ZZ..................................... Extirpation of matter from left external iliac vein, percutaneous
approach.
06CG4ZZ..................................... Extirpation of matter from left external iliac vein, percutaneous
endoscopic approach.
06CH0ZZ..................................... Extirpation of matter from right hypogastric vein, open approach.
06CH3ZZ..................................... Extirpation of matter from right hypogastric vein, percutaneous
approach.
06CH4ZZ..................................... Extirpation of matter from right hypogastric vein, percutaneous
endoscopic approach.
[[Page 24372]]
06CJ0ZZ..................................... Extirpation of matter from left hypogastric vein, open approach.
06CJ3ZZ..................................... Extirpation of matter from left hypogastric vein, percutaneous
approach.
06CJ4ZZ..................................... 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 Code description
----------------------------------------------------------------------------------------------------------------
02CP0ZZ..................................... Extirpation of matter from pulmonary trunk, open approach.
02CP3ZZ..................................... Extirpation of matter from pulmonary trunk, percutaneous approach.
02CP4ZZ..................................... Extirpation of matter from pulmonary trunk, percutaneous
endoscopic approach.
02CQ0ZZ..................................... Extirpation of matter from right pulmonary artery, open approach.
02CQ3ZZ..................................... Extirpation of matter from right pulmonary artery, percutaneous
approach.
02CQ4ZZ..................................... Extirpation of matter from right pulmonary artery, percutaneous
endoscopic approach.
02CR0ZZ..................................... Extirpation of matter from left pulmonary artery, open approach.
02CR3ZZ..................................... Extirpation of matter from left pulmonary artery, percutaneous
approach.
02CR4ZZ..................................... Extirpation of matter from left pulmonary artery, percutaneous
endoscopic approach.
02CS0ZZ..................................... Extirpation of matter from right pulmonary vein, open approach.
02CS3ZZ..................................... Extirpation of matter from right pulmonary vein, percutaneous
approach.
02CS4ZZ..................................... Extirpation of matter from right pulmonary vein, percutaneous
endoscopic approach.
02CT0ZZ..................................... Extirpation of matter from left pulmonary vein, open approach.
02CT3ZZ..................................... Extirpation of matter from left pulmonary vein, percutaneous
approach.
02CT4ZZ..................................... Extirpation of matter from left pulmonary vein, percutaneous
endoscopic approach.
02CV0ZZ..................................... Extirpation of matter from superior vena cava, open approach.
02CV3ZZ..................................... Extirpation of matter from superior vena cava, percutaneous
approach.
02CV4ZZ..................................... Extirpation of matter from superior vena cava, percutaneous
endoscopic approach.
03C00ZZ..................................... Extirpation of matter from right internal mammary artery, open
approach.
03C03ZZ..................................... Extirpation of matter from right internal mammary artery,
percutaneous approach.
03C04ZZ..................................... Extirpation of matter from right internal mammary artery,
percutaneous endoscopic approach.
03C10ZZ..................................... Extirpation of matter from left internal mammary artery, open
approach.
03C13ZZ..................................... Extirpation of matter from left internal mammary artery,
percutaneous approach.
03C14ZZ..................................... Extirpation of matter from left internal mammary artery,
percutaneous endoscopic approach.
03C20ZZ..................................... Extirpation of matter from innominate artery, open approach.
03C23ZZ..................................... Extirpation of matter from innominate artery, percutaneous
approach.
03C24ZZ..................................... Extirpation of matter from innominate artery, percutaneous
endoscopic approach.
03C30ZZ..................................... Extirpation of matter from right subclavian artery, open approach.
03C33ZZ..................................... Extirpation of matter from right subclavian artery, percutaneous
approach.
03C34ZZ..................................... Extirpation of matter from right subclavian artery, percutaneous
endoscopic approach.
03C40ZZ..................................... Extirpation of matter from left subclavian artery, open approach.
03C43ZZ..................................... Extirpation of matter from left subclavian artery, percutaneous
approach.
03C44ZZ..................................... Extirpation of matter from 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: http://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
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
02BP0ZZ..................................... Excision of pulmonary trunk, open approach.
02BP4ZZ..................................... Excision of pulmonary trunk, percutaneous endoscopic approach.
02BQ0ZZ..................................... Excision of right pulmonary artery, open approach.
02BQ4ZZ..................................... Excision of right pulmonary artery, percutaneous endoscopic
approach.
02BR0ZZ..................................... Excision of left pulmonary artery, open approach.
02BR4ZZ..................................... Excision of left pulmonary artery, percutaneous endoscopic
approach.
02BS0ZZ..................................... Excision of right pulmonary vein, open approach.
02BS4ZZ..................................... Excision of right pulmonary vein, percutaneous endoscopic
approach.
02BT0ZZ..................................... Excision of left pulmonary vein, open approach.
02BT4ZZ..................................... Excision of left pulmonary vein, percutaneous endoscopic approach.
02BV0ZZ..................................... Excision of superior vena cava, open approach.
02BV4ZZ..................................... Excision of superior vena cava, percutaneous endoscopic approach.
03B00ZZ..................................... Excision of right internal mammary artery, open approach.
03B04ZZ..................................... Excision of right internal mammary artery, percutaneous endoscopic
approach.
03B10ZZ..................................... Excision of left internal mammary artery, open approach.
[[Page 24373]]
03B14ZZ..................................... Excision of left internal mammary artery, percutaneous endoscopic
approach.
03B20ZZ..................................... Excision of innominate artery, open approach.
03B24ZZ..................................... Excision of innominate artery, percutaneous endoscopic approach.
03B30ZZ..................................... Excision of right subclavian artery, open approach.
03B34ZZ..................................... Excision of right subclavian artery, percutaneous endoscopic
approach.
03B40ZZ..................................... Excision of left subclavian artery, open approach.
03B44ZZ..................................... Excision of left subclavian artery, percutaneous endoscopic
approach.
05B00ZZ..................................... Excision of azygos vein, open approach.
05B04ZZ..................................... Excision of azygos vein, percutaneous endoscopic approach.
05B10ZZ..................................... Excision of hemiazygos vein, open approach.
05B14ZZ..................................... Excision of hemiazygos vein, percutaneous endoscopic approach.
05B30ZZ..................................... Excision of right innominate vein, open approach.
05B34ZZ..................................... Excision of right innominate vein, percutaneous endoscopic
approach.
05B40ZZ..................................... Excision of left innominate vein, open approach.
05B44ZZ..................................... Excision of left innominate vein, percutaneous endoscopic
approach.
05B50ZZ..................................... Excision of right subclavian vein, open approach.
05B54ZZ..................................... Excision of right subclavian vein, percutaneous endoscopic
approach.
05B60ZZ..................................... Excision of left subclavian vein, open approach.
05B64ZZ..................................... Excision of left subclavian vein, percutaneous endoscopic
approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.36
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
04B10ZZ..................................... Excision of celiac artery, open approach.
04B14ZZ..................................... Excision of celiac artery, percutaneous endoscopic approach.
04B20ZZ..................................... Excision of gastric artery, open approach.
04B24ZZ..................................... Excision of gastric artery, percutaneous endoscopic approach.
04B30ZZ..................................... Excision of hepatic artery, open approach.
04B34ZZ..................................... Excision of hepatic artery, percutaneous endoscopic approach.
04B40ZZ..................................... Excision of splenic artery, open approach.
04B44ZZ..................................... Excision of splenic artery, percutaneous endoscopic approach.
04B50ZZ..................................... Excision of superior mesenteric artery, open approach.
04B54ZZ..................................... Excision of superior mesenteric artery, percutaneous endoscopic
approach.
04B60ZZ..................................... Excision of right colic artery, open approach.
04B64ZZ..................................... Excision of right colic artery, percutaneous endoscopic approach.
04B70ZZ..................................... Excision of left colic artery, open approach.
04B74ZZ..................................... Excision of left colic artery, percutaneous endoscopic approach.
04B80ZZ..................................... Excision of middle colic artery, open approach.
04B84ZZ..................................... Excision of middle colic artery, percutaneous endoscopic approach.
04B90ZZ..................................... Excision of right renal artery, open approach.
04B94ZZ..................................... Excision of right renal artery, percutaneous endoscopic approach.
04BA0ZZ..................................... Excision of left renal artery, open approach.
04BA4ZZ..................................... Excision of left renal artery, percutaneous endoscopic approach.
04BB0ZZ..................................... Excision of inferior mesenteric artery, open approach.
04BB4ZZ..................................... Excision of inferior mesenteric artery, percutaneous endoscopic
approach.
04BC0ZZ..................................... Excision of right common iliac artery, open approach.
04BC4ZZ..................................... Excision of right common iliac artery, percutaneous endoscopic
approach.
04BD0ZZ..................................... Excision of left common iliac artery, open approach.
04BD4ZZ..................................... Excision of left common iliac artery, percutaneous endoscopic
approach.
04BE0ZZ..................................... Excision of right internal iliac artery, open approach.
04BE4ZZ..................................... Excision of right internal iliac artery, percutaneous endoscopic
approach.
04BF0ZZ..................................... Excision of left internal iliac artery, open approach.
04BF4ZZ..................................... Excision of left internal iliac artery, percutaneous endoscopic
approach.
04BH0ZZ..................................... Excision of right external iliac artery, open approach.
04BH4ZZ..................................... Excision of right external iliac artery, percutaneous endoscopic
approach.
04BJ0ZZ..................................... Excision of left external iliac artery, open approach.
04BJ4ZZ..................................... Excision of left external iliac artery, percutaneous endoscopic
approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 38.37
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
06B00ZZ..................................... Excision of inferior vena cava, open approach.
06B04ZZ..................................... Excision of inferior vena cava, percutaneous endoscopic approach.
06B10ZZ..................................... Excision of splenic vein, open approach.
06B14ZZ..................................... Excision of splenic vein, percutaneous endoscopic approach.
06B20ZZ..................................... Excision of gastric vein, open approach.
06B24ZZ..................................... Excision of gastric vein, percutaneous endoscopic approach.
06B40ZZ..................................... Excision of hepatic vein, open approach.
[[Page 24374]]
06B44ZZ..................................... Excision of hepatic vein, percutaneous endoscopic approach.
06B50ZZ..................................... Excision of superior mesenteric vein, open approach.
06B54ZZ..................................... Excision of superior mesenteric vein, percutaneous endoscopic
approach.
06B60ZZ..................................... Excision of inferior mesenteric vein, open approach.
06B64ZZ..................................... Excision of inferior mesenteric vein, percutaneous endoscopic
approach.
06B70ZZ..................................... Excision of colic vein, open approach.
06B74ZZ..................................... Excision of colic vein, percutaneous endoscopic approach.
06B80ZZ..................................... Excision of portal vein, open approach.
06B84ZZ..................................... Excision of portal vein, percutaneous endoscopic approach.
06B90ZZ..................................... Excision of right renal vein, open approach.
06B94ZZ..................................... Excision of right renal vein, percutaneous endoscopic approach.
06BB0ZZ..................................... Excision of left renal vein, open approach.
06BB4ZZ..................................... Excision of left renal vein, percutaneous endoscopic approach.
06BC0ZZ..................................... Excision of right common iliac vein, open approach.
06BC4ZZ..................................... Excision of right common iliac vein, percutaneous endoscopic
approach.
06BD0ZZ..................................... Excision of left common iliac vein, open approach.
06BD4ZZ..................................... Excision of left common iliac vein, percutaneous endoscopic
approach.
06BF0ZZ..................................... Excision of right external iliac vein, open approach.
06BF4ZZ..................................... Excision of right external iliac vein, percutaneous endoscopic
approach.
06BG0ZZ..................................... Excision of left external iliac vein, open approach.
06BG4ZZ..................................... Excision of left external iliac vein, percutaneous endoscopic
approach.
06BH0ZZ..................................... Excision of right hypogastric vein, open approach.
06BH4ZZ..................................... Excision of right hypogastric vein, percutaneous endoscopic
approach.
06BJ0ZZ..................................... Excision of left hypogastric vein, open approach.
06BJ4ZZ..................................... Excision of 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: http://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: http://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: http://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
----------------------------------------------------------------------------------------------------------------
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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
----------------------------------------------------------------------------------------------------------------
[[Page 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: http://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: http://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: http://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: http://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: http://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: http://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
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
021V09P..................................... Bypass superior vena cava to pulmonary trunk with autologous
venous tissue, open approach.
021V09Q..................................... Bypass superior vena cava to right pulmonary artery with
autologous venous tissue, open approach.
021V09R..................................... Bypass superior vena cava to left pulmonary artery with autologous
venous tissue, open approach.
021V0AP..................................... Bypass superior vena cava to pulmonary trunk with autologous
arterial tissue, open approach.
021V0AQ..................................... Bypass superior vena cava to right pulmonary artery with
autologous arterial tissue, open approach.
021V0AR..................................... Bypass superior vena cava to left pulmonary artery with autologous
arterial tissue, open approach.
021V0JP..................................... Bypass superior vena cava to pulmonary trunk with synthetic
substitute, open approach.
021V0JQ..................................... Bypass superior vena cava to right pulmonary artery with synthetic
substitute, open approach.
021V0JR..................................... Bypass superior vena cava to left pulmonary artery with synthetic
substitute, open approach.
021V0KP..................................... Bypass superior vena cava to pulmonary trunk with nonautologous
tissue substitute, open approach.
021V0KQ..................................... Bypass superior vena cava to right pulmonary artery with
nonautologous tissue substitute, open approach.
021V0KR..................................... Bypass superior vena cava to left pulmonary artery with
nonautologous tissue substitute, open approach.
021V0ZP..................................... Bypass superior vena cava to pulmonary trunk, open approach.
021V0ZQ..................................... Bypass superior vena cava to right pulmonary artery, open
approach.
021V0ZR..................................... Bypass superior vena cava to left pulmonary artery, open approach.
021V49P..................................... Bypass superior vena cava to pulmonary trunk with autologous
venous tissue, percutaneous endoscopic approach.
021V49Q..................................... Bypass superior vena cava to right pulmonary artery with
autologous venous tissue, percutaneous endoscopic approach.
[[Page 24376]]
021V49R..................................... Bypass superior vena cava to left pulmonary artery with autologous
venous tissue, percutaneous endoscopic approach.
021V4AP..................................... Bypass superior vena cava to pulmonary trunk with autologous
arterial tissue, percutaneous endoscopic approach.
021V4AQ..................................... Bypass superior vena cava to right pulmonary artery with
autologous arterial tissue, percutaneous endoscopic approach.
021V4AR..................................... Bypass superior vena cava to left pulmonary artery with autologous
arterial tissue, percutaneous endoscopic approach.
021V4JP..................................... Bypass superior vena cava to pulmonary trunk with synthetic
substitute, percutaneous endoscopic approach.
021V4JQ..................................... Bypass superior vena cava to right pulmonary artery with synthetic
substitute, percutaneous endoscopic approach.
021V4JR..................................... Bypass superior vena cava to left pulmonary artery with synthetic
substitute, percutaneous endoscopic approach.
021V4KP..................................... Bypass superior vena cava to pulmonary trunk with nonautologous
tissue substitute, percutaneous endoscopic approach.
021V4KQ..................................... Bypass superior vena cava to right pulmonary artery with
nonautologous tissue substitute, percutaneous endoscopic
approach.
021V4KR..................................... Bypass superior vena cava to left pulmonary artery with
nonautologous tissue substitute, percutaneous endoscopic
approach.
021V4ZP..................................... Bypass superior vena cava to pulmonary trunk, percutaneous
endoscopic approach.
021V4ZQ..................................... Bypass superior vena cava to right pulmonary artery, percutaneous
endoscopic approach.
021V4ZR..................................... Bypass superior vena cava to left pulmonary artery, percutaneous
endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.22
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
021W09B..................................... Bypass thoracic aorta to subclavian with autologous venous tissue,
open approach).
021W09D..................................... Bypass thoracic aorta to carotid with autologous venous tissue,
open approach).
021W0AB..................................... Bypass thoracic aorta to subclavian with autologous arterial
tissue, open approach.
021W0AD..................................... Bypass thoracic aorta to carotid with autologous arterial tissue,
open approach.
021W0JB..................................... Bypass thoracic aorta to subclavian with synthetic substitute,
open approach.
021W0JD..................................... Bypass thoracic aorta to carotid with synthetic substitute, open
approach.
021W0KB..................................... Bypass thoracic aorta to subclavian with nonautologous tissue
substitute, open approach.
021W0KD..................................... Bypass thoracic aorta to carotid with nonautologous tissue
substitute, open approach.
021W0ZB..................................... Bypass thoracic aorta to subclavian, open approach.
021W0ZD..................................... Bypass thoracic aorta to carotid, open approach.
021W49B..................................... Bypass thoracic aorta to subclavian with autologous venous tissue,
percutaneous endoscopic approach.
021W49D..................................... Bypass thoracic aorta to carotid with autologous venous tissue,
percutaneous endoscopic approach.
021W4AB..................................... Bypass thoracic aorta to subclavian with autologous arterial
tissue, percutaneous endoscopic approach.
021W4AD..................................... Bypass thoracic aorta to carotid with autologous arterial tissue,
percutaneous endoscopic approach.
021W4JB..................................... Bypass thoracic aorta to subclavian with synthetic substitute,
percutaneous endoscopic approach.
021W4JD..................................... Bypass thoracic aorta to carotid with synthetic substitute,
percutaneous endoscopic approach.
021W4KB..................................... Bypass thoracic aorta to subclavian with nonautologous tissue
substitute, percutaneous endoscopic approach.
021W4KD..................................... Bypass thoracic aorta to carotid with nonautologous tissue
substitute, percutaneous endoscopic approach.
021W4ZB..................................... Bypass thoracic aorta to subclavian, percutaneous endoscopic
approach.
021W4ZD..................................... Bypass thoracic aorta to 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: http://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
----------------------------------------------------------------------------------------------------------------
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: http://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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
----------------------------------------------------------------------------------------------------------------
[[Page 24377]]
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: http://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 Code description
----------------------------------------------------------------------------------------------------------------
02QW0ZZ..................................... Repair thoracic aorta, open approach.
02QW3ZZ..................................... Repair thoracic aorta, percutaneous approach.
02QW4ZZ..................................... Repair thoracic aorta, percutaneous endoscopic approach.
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS Code Translations for ICD-9-CM Procedure Code 39.72
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
03LR0DZ..................................... Occlusion of face artery with intraluminal device, open approach.
03LR3DZ..................................... Occlusion of face artery with intraluminal device, percutaneous
approach.
03LR4DZ..................................... Occlusion of face artery with intraluminal device, percutaneous
endoscopic approach.
03LS0DZ..................................... Occlusion of right temporal artery with intraluminal device, open
approach.
03LS3DZ..................................... Occlusion of right temporal artery with intraluminal device,
percutaneous approach.
03LS4DZ..................................... Occlusion of right temporal artery with intraluminal device,
percutaneous endoscopic approach.
03LT0DZ..................................... Occlusion of left temporal artery with intraluminal device, open
approach.
03LT3DZ..................................... Occlusion of left temporal artery with intraluminal device,
percutaneous approach.
03LT4DZ..................................... Occlusion of 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: http://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: http://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
----------------------------------------------------------------------------------------------------------------
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: http://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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 237 and 238--Combined................................... 50,567 5.8 $29,174
[[Page 24378]]
MS-DRGs 237 and 238--Cases with more complex, more invasive 22,278 4.0 31,729
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 28,289 7.1 27,162
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
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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
Proposed New MS-DRG 268 with MCC................................ 4,182 10.03 $45,996
Proposed New MS-DRG 269 without MCC............................. 18,096 2.68 28,431
----------------------------------------------------------------------------------------------------------------
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 3-way 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, 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
Proposed New MS-DRG 270 with MCC................................ 14,158 9.3 $33,507
Proposed New MS-DRG 271 with CC................................. 9,648 5.99 22,800
Proposed New MS-DRG 272 without CC/MCC.......................... 4,483 3.08 16,438
----------------------------------------------------------------------------------------------------------------
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:
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);
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
[[Page 24379]]
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.
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 Code description ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
0SP908Z.................. Removal of spacer from and 0SR9019.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR901A.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR901Z.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SR9029.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR902A.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR902Z.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SR9039.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR903A.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR903Z.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SR9049.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR904A.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR904Z.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SR90J9.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR90JA.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SR90JZ.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SRA009.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
[[Page 24380]]
0SP908Z.................. Removal of spacer from and 0SRA00A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA00Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA019.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA01A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA01Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SRA039.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA03A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA03Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SRA0J9.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute, cemented,
pen approach.
0SP908Z.................. Removal of spacer from and 0SRA0JA.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRA0JZ.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR019.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR01A.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR01Z.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SRR039.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR03A.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR03Z.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
open approach.
0SP908Z.................. Removal of spacer from and 0SRR0J9.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
Substitute, cemented,
open approach.
0SP908Z.................. Removal of spacer from and 0SRR0JA.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
Substitute,
uncemented, open
approach.
0SP908Z.................. Removal of spacer from and 0SRR0JZ.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
substitute, open
approach.
0SP908Z.................. Removal of spacer from and 0SU909Z.................. Supplement right hip
right hip joint, open joint with liner, open
approach. approach.
0SP908Z.................. Removal of spacer from and 0SUA09Z.................. Supplement right hip
right hip joint, open joint, acetabular
approach. surface with liner,
open approach.
0SP908Z.................. Removal of spacer from and 0SUR09Z.................. Supplement right hip
right hip joint, open joint, femoral surface
approach. with liner, open
approach.
0SP909Z.................. Removal of liner from and 0SR9019.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR901A.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR901Z.................. Replacement of right
right hip joint, open hip joint with metal
approach. synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SR9029.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
cemented, open
approach.
[[Page 24381]]
0SP909Z.................. Removal of liner from and 0SR902A.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR902Z.................. Replacement of right
right hip joint, open hip joint with metal
approach. on polyethylene
synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SR9039.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR903A.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR903Z.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SR9049.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR904A.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR904Z.................. Replacement of right
right hip joint, open hip joint with ceramic
approach. on polyethylene
synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SR90J9.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR90JA.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SR90JZ.................. Replacement of right
right hip joint, open hip joint with
approach. synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SRA009.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
0SP909Z.................. Removal of liner from and 0SRA00A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA00Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with
polyethylene synthetic
substitute, open
approach.
0SP909Z.................. Removal of liner from and 0SRA019.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA01A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA01Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with metal
synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SRA039.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA03A.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA03Z.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with ceramic
synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SRA0J9.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute, cemented,
open approach.
0SP909Z.................. Removal of liner from and 0SRA0JA.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRA0JZ.................. Replacement of right
right hip joint, open hip joint, acetabular
approach. surface with synthetic
substitute, open
approach.
0SP909Z.................. Removal of liner from and 0SRR019.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRR01A.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRR01Z.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with metal
synthetic substitute,
open approach.
[[Page 24382]]
0SP909Z.................. Removal of liner from and 0SRR039.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRR03A.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRR03Z.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with ceramic
synthetic substitute,
open approach.
0SP909Z.................. Removal of liner from and 0SRR0J9.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
substitute, cemented,
open approach.
0SP909Z.................. Removal of liner from and 0SRR0JA.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SP909Z.................. Removal of liner from and 0SRR0JZ.................. Replacement of right
right hip joint, open hip joint, femoral
approach. surface with synthetic
substitute, open
approach.
0SP909Z.................. Removal of liner from and 0SU909Z.................. Supplement right hip
right hip joint, open joint with liner, open
approach. approach.
0SP909Z.................. Removal of liner from and 0SUA09Z.................. Supplement right hip
right hip joint, open joint, acetabular
approach. surface with liner,
open approach.
0SP909Z.................. Removal of liner from and 0SUR09Z.................. Supplement right hip
right hip joint, open joint, femoral surface
approach. with liner, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR9019.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR901A.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR901Z.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SR9029.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. on polyethylene
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR902A.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR902Z.................. Replacement of right
device from right hip hip joint with metal
joint, open approach. on polyethylene
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SR9039.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR903A.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR903Z.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SR9049.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. on polyethylene
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR904A.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. on polyethylene
synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR904Z.................. Replacement of right
device from right hip hip joint with ceramic
joint, open approach. on polyethylene
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SR90J9.................. Replacement of right
device from right hip hip joint with
joint, open approach. synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR90JA.................. Replacement of right
device from right hip hip joint with
joint, open approach. synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SR90JZ.................. Replacement of right
device from right hip hip joint with
joint, open approach. synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRA009.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRA00A.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA00Z.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA019.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA01A.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
uncemented, open
approach.
[[Page 24383]]
0SP90BZ.................. Removal of resurfacing and 0SRA01Z.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRA039.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA03A.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA03Z.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRA0J9.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with synthetic
substitute, cemented,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRA0JA.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. surface with synthetic
substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRA0JZ.................. Replacement of right
device from right hip hip joint, acetabular
joint, open approach. Surface with synthetic
substitute, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR019.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR01A.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR01Z.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with metal
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRR039.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR03A.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR03Z.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with ceramic
synthetic substitute,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRR0J9.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with synthetic
substitute, cemented,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SRR0JA.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with synthetic
substitute,
uncemented, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SRR0JZ.................. Replacement of right
device from right hip hip joint, femoral
joint, open approach. surface with synthetic
substitute, open
approach.
0SP90BZ.................. Removal of resurfacing and 0SU909Z.................. Supplement right hip
device from right hip joint with liner, open
joint, open approach. approach.
0SP90BZ.................. Removal of resurfacing and 0SUA09Z.................. Supplement right hip
device from right hip joint, acetabular
joint, open approach. surface with liner,
open approach.
0SP90BZ.................. Removal of resurfacing and 0SUR09Z.................. Supplement right hip
device from right hip joint, femoral surface
joint, open approach. with liner, open
approach.
0SP90JZ.................. Removal of synthetic and 0SR9049.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, open on polyethylene
approach. synthetic substitute,
cemented, open
approach.
0SP90JZ.................. Removal of synthetic and 0SR904A.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, open on polyethylene
approach. synthetic substitute,
uncemented, open
approach.
0SP90JZ.................. Removal of synthetic and 0SR904Z.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, open on polyethylene
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SR9019.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic synthetic substitute,
approach. cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR901A.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic synthetic substitute,
approach. uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR901Z.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic synthetic substitute,
approach. open approach.
0SP948Z.................. Removal of spacer from and 0SR9029.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR902A.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR902Z.................. Replacement of right
right hip joint, hip joint with metal
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
open approach.
[[Page 24384]]
0SP948Z.................. Removal of spacer from and 0SR9039.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR903A.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR903Z.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. open approach.
0SP948Z.................. Removal of spacer from and 0SR9049.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR904A.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR904Z.................. Replacement of right
right hip joint, hip joint with ceramic
percutaneous endoscopic on polyethylene
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SR90J9.................. Replacement of right
right hip joint, hip joint with
percutaneous endoscopic synthetic substitute,
approach. cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR90JA.................. Replacement of right
right hip joint, hip joint with
percutaneous endoscopic synthetic substitute,
approach. uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SR90JZ.................. Replacement of right
right hip joint, hip joint with
percutaneous endoscopic synthetic substitute,
approach. open approach.
0SP948Z.................. Removal of spacer from and 0SRA009.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SP948Z.................. Removal of spacer from and 0SRA00A.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA00Z.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA019.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with metal
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA01A.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic Surface with metal
approach. synthetic substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA01Z.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with metal
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SRA039.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA03A.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA03Z.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SRA0J9.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute, cemented,
open approach.
0SP948Z.................. Removal of spacer from and 0SRA0JA.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRA0JZ.................. Replacement of right
right hip joint, hip joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute, open
approach.
0SP948Z.................. Removal of spacer from and 0SRR019.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with metal
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRR01A.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with metal
approach. synthetic substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRR01Z.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with metal
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SRR039.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRR03A.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
uncemented, open
approach.
[[Page 24385]]
0SP948Z.................. Removal of spacer from and 0SRR03Z.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
open approach.
0SP948Z.................. Removal of spacer from and 0SRR0J9.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with synthetic
approach. substitute, cemented,
open approach.
0SP948Z.................. Removal of spacer from and 0SRR0JA.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with synthetic
approach. substitute,
uncemented, open
approach.
0SP948Z.................. Removal of spacer from and 0SRR0JZ.................. Replacement of right
right hip joint, hip joint, femoral
percutaneous endoscopic surface with synthetic
approach. substitute, open
approach.
0SP948Z.................. Removal of spacer from and 0SU909Z.................. Supplement right hip
right hip joint, joint with liner, open
percutaneous endoscopic approach.
approach.
0SP948Z.................. Removal of spacer from and 0SUA09Z.................. Supplement right hip
right hip joint, joint, acetabular
percutaneous endoscopic surface with liner,
approach. open approach.
0SP948Z.................. Removal of spacer from and 0SUR09Z.................. Supplement right hip
right hip joint, joint, femoral surface
percutaneous endoscopic with liner, open
approach. approach.
0SP94JZ.................. Removal of synthetic and 0SR9019.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR901A.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR901Z.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. open approach.
0SP94JZ.................. Removal of synthetic and 0SR9029.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR902A.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR902Z.................. Replacement of right
substitute from right hip joint with metal
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SR9039.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR903A.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR903Z.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. open approach.
0SP94JZ.................. Removal of synthetic and 0SR9049.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR904A.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR904Z.................. Replacement of right
substitute from right hip joint with ceramic
hip joint, percutaneous on polyethylene
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SR90J9.................. Replacement of right
substitute from right hip joint with
hip joint, percutaneous synthetic substitute,
endoscopic approach. cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR90JA.................. Replacement of right
substitute from right hip joint with
hip joint, percutaneous synthetic substitute,
endoscopic approach. uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SR90JZ.................. Replacement of right
substitute from right hip joint with
hip joint, percutaneous synthetic substitute,
endoscopic approach. open approach.
0SP94JZ.................. Removal of synthetic and 0SRA009.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute, cemented,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRA00A.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA00Z.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA019.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA01A.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA01Z.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRA039.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
cemented, open
approach.
[[Page 24386]]
0SP94JZ.................. Removal of synthetic and 0SRA03A.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA03Z.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRA0J9.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, cemented,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRA0JA.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRA0JZ.................. Replacement of right
substitute from right hip joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR019.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR01A.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR01Z.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRR039.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR03A.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR03Z.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRR0J9.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, cemented,
open approach.
0SP94JZ.................. Removal of synthetic and 0SRR0JA.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SP94JZ.................. Removal of synthetic and 0SRR0JZ.................. Replacement of right
substitute from right hip joint, femoral
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, open
approach.
0SP94JZ.................. Removal of synthetic and 0SU909Z.................. Supplement right hip
substitute from right joint with liner, open
hip joint, percutaneous approach.
endoscopic approach.
0SP94JZ.................. Removal of synthetic and 0SUA09Z.................. Supplement right hip
substitute from right joint, acetabular
hip joint, percutaneous surface with liner,
endoscopic approach. open approach.
0SP94JZ.................. Removal of synthetic and 0SUR09Z.................. Supplement right hip
substitute from right joint, femoral surface
hip joint, percutaneous with liner, open
endoscopic approach. approach.
0SPB08Z.................. Removal of spacer from and 0SRB019.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
cemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB01A.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB01Z.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRB029.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRB02A.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB02Z.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB039.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB03A.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB03Z.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRB049.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRB04A.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
[[Page 24387]]
0SPB08Z.................. Removal of spacer from and 0SRB04Z.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB0J9.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRB0JA.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRB0JZ.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE009.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRE00A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE00Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE019.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE01A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE01Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRE039.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE03A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE03Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRE0J9.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRE0JA.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRE0JZ.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS019.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRS01A.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS01Z.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS039.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRS03A.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS03Z.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS0J9.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute, cemented,
open approach.
0SPB08Z.................. Removal of spacer from and 0SRS0JA.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute,
uncemented, open
approach.
0SPB08Z.................. Removal of spacer from and 0SRS0JZ.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute, open
approach.
0SPB08Z.................. Removal of spacer from and 0SUB09Z.................. Supplement left hip
left hip joint, open joint with liner, open
approach. approach.
0SPB08Z.................. Removal of spacer from and 0SUE09Z.................. Supplement left hip
left hip joint, open joint, acetabular
approach. surface with liner,
open approach.
[[Page 24388]]
0SPB08Z.................. Removal of spacer from and 0SUS09Z.................. Supplement left hip
left hip joint, open joint, femoral surface
approach. with liner, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB019.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
cemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB01A.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB01Z.................. Replacement of left hip
left hip joint, open joint with metal
approach. synthetic substitute,
open approach.
0SPB09Z.................. Removal of liner from and 0SRB029.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRB02A.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB02Z.................. Replacement of left hip
left hip joint, open joint with metal on
approach. polyethylene synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB039.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB03A.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB03Z.................. Replacement of left hip
left hip joint, open joint with ceramic
approach. synthetic substitute,
open approach.
0SPB09Z.................. Removal of liner from and 0SRB049.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRB04A.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB04Z.................. Replacement of left hip
left hip joint, open joint with ceramic on
approach. polyethylene synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB0J9.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRB0JA.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRB0JZ.................. Replacement of left hip
left hip joint, open joint with synthetic
approach. substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE009.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRE00A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE00Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with
polyethylene synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE019.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE01A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE01Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with metal
synthetic substitute,
open approach.
0SPB09Z.................. Removal of liner from and 0SRE039.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE03A.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE03Z.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with ceramic
synthetic substitute,
open approach.
0SPB09Z.................. Removal of liner from and 0SRE0J9.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRE0JA.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRE0JZ.................. Replacement of left hip
left hip joint, open joint, acetabular
approach. surface with synthetic
substitute, open
approach.
[[Page 24389]]
0SPB09Z.................. Removal of liner from and 0SRS019.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRS01A.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRS01Z.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with metal synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRS039.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRS03A.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRS03Z.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with ceramic synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SRS0J9.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute, cemented,
open approach.
0SPB09Z.................. Removal of liner from and 0SRS0JA.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute,
uncemented, open
approach.
0SPB09Z.................. Removal of liner from and 0SRS0JZ.................. Replacement of left hip
left hip joint, open joint, femoral surface
approach. with synthetic
substitute, open
approach.
0SPB09Z.................. Removal of liner from and 0SUB09Z.................. Supplement left hip
left hip joint, open joint with liner, open
approach. approach.
0SPB09Z.................. Removal of liner from and 0SUE09Z.................. Supplement left hip
left hip joint, open joint, acetabular
approach. surface with liner,
open approach.
0SPB09Z.................. Removal of liner from and 0SUS09Z.................. Supplement left hip
left hip joint, open joint, femoral surface
approach. with liner, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB019.................. Replacement of left hip
device from left hip joint with metal
joint, open approach. synthetic substitute,
cemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB01A.................. Replacement of left hip
device from left hip joint with metal
joint, open approach. synthetic substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB01Z.................. Replacement of left hip
device from left hip joint with metal
joint, open approach. synthetic substitute,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB029.................. Replacement of left hip
device from left hip joint with metal on
joint, open approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB02A.................. Replacement of left hip
device from left hip joint with metal on
joint, open approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB02Z.................. Replacement of left hip
device from left hip joint with metal on
joint, open approach. polyethylene synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB039.................. Replacement of left hip
device from left hip joint with ceramic
joint, open approach. synthetic substitute,
cemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB03A.................. Replacement of left hip
device from left hip joint with ceramic
joint, open approach. synthetic substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB03Z.................. Replacement of left hip
device from left hip joint with ceramic
joint, open approach. synthetic substitute,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB049.................. Replacement of left hip
device from left hip joint with ceramic on
joint, open approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB04A.................. Replacement of left hip
device from left hip joint with ceramic on
joint, open approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB04Z.................. Replacement of left hip
device from left hip joint with ceramic on
joint, open approach. polyethylene synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB0J9.................. Replacement of left hip
device from left hip joint with synthetic
joint, open approach. substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB0JA.................. Replacement of left hip
device from left hip joint with synthetic
joint, open approach. substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRB0JZ.................. Replacement of left hip
device from left hip joint with synthetic
joint, open approach. substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE009.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE00A.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute,
uncemented, open
approach.
[[Page 24390]]
0SPB0BZ.................. Removal of resurfacing and 0SRE00Z.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with
polyethylene synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE019.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
cemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE01A.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE01Z.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with metal
synthetic substitute,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE039.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
cemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE03A.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE03Z.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with ceramic
synthetic substitute,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE0J9.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE0JA.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRE0JZ.................. Replacement of left hip
device from left hip joint, acetabular
joint, open approach. surface with synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS019.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with metal synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS01A.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with metal synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS01Z.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with metal synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS039.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with ceramic synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS03A.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with ceramic synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS03Z.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with ceramic synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS0J9.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with synthetic
substitute, cemented,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS0JA.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with synthetic
substitute,
uncemented, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SRS0JZ.................. Replacement of left hip
device from left hip joint, femoral surface
joint, open approach. with synthetic
substitute, open
approach.
0SPB0BZ.................. Removal of resurfacing and 0SUB09Z.................. Supplement left hip
device from left hip joint with liner, open
joint, open approach. approach.
0SPB0BZ.................. Removal of resurfacing and 0SUE09Z.................. Supplement left hip
device from left hip joint, acetabular
joint, open approach. surface with liner,
open approach.
0SPB0BZ.................. Removal of resurfacing and 0SUS09Z.................. Supplement left hip
device from left hip joint, femoral surface
joint, open approach. with liner, open
approach.
0SPB0JZ.................. Removal of synthetic and 0SRB049.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, open polyethylene synthetic
approach. substitute, cemented,
open approach.
0SPB0JZ.................. Removal of synthetic and 0SRB04A.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, open polyethylene synthetic
approach. substitute,
uncemented, open
approach.
0SPB0JZ.................. Removal of synthetic and 0SRB04Z.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, open polyethylene synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB019.................. Replacement of left hip
left hip joint, joint with metal
percutaneous endoscopic synthetic substitute,
approach. cemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB01A.................. Replacement of left hip
left hip joint, joint with metal
percutaneous endoscopic synthetic substitute,
approach. uncemented, open
approach.
[[Page 24391]]
0SPB48Z.................. Removal of spacer from and 0SRB01Z.................. Replacement of left hip
left hip joint, joint with metal
percutaneous endoscopic synthetic substitute,
approach. open approach.
0SPB48Z.................. Removal of spacer from and 0SRB029.................. Replacement of left hip
left hip joint, joint with metal on
percutaneous endoscopic polyethylene synthetic
approach. substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRB02A.................. Replacement of left hip
left hip joint, joint with metal on
percutaneous endoscopic polyethylene synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB02Z.................. Replacement of left hip
left hip joint, joint with metal on
percutaneous endoscopic polyethylene synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB039.................. Replacement of left hip
left hip joint, joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. cemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB03A.................. Replacement of left hip
left hip joint, joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB03Z.................. Replacement of left hip
left hip joint, joint with ceramic
percutaneous endoscopic synthetic substitute,
approach. open approach.
0SPB48Z.................. Removal of spacer from and 0SRB049.................. Replacement of left hip
left hip joint, joint with ceramic on
percutaneous endoscopic polyethylene synthetic
approach. substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRB04A.................. Replacement of left hip
left hip joint, joint with ceramic on
percutaneous endoscopic polyethylene synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB04Z.................. Replacement of left hip
left hip joint, joint with ceramic on
percutaneous endoscopic polyethylene synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB0J9.................. Replacement of left hip
left hip joint, joint with synthetic
percutaneous endoscopic substitute, cemented,
approach. open approach.
0SPB48Z.................. Removal of spacer from and 0SRB0JA.................. Replacement of left hip
left hip joint, joint with synthetic
percutaneous endoscopic substitute,
approach. uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRB0JZ.................. Replacement of left hip
left hip joint, joint with synthetic
percutaneous endoscopic substitute, open
approach. approach.
0SPB48Z.................. Removal of spacer from and 0SRE009.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRE00A.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE00Z.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with
approach. polyethylene synthetic
substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE019.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with metal
approach. synthetic substitute,
cemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE01A.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with metal
approach. synthetic substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE01Z.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with metal
approach. synthetic substitute,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRE039.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
cemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE03A.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE03Z.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with ceramic
approach. synthetic substitute,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRE0J9.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRE0JA.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRE0JZ.................. Replacement of left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS019.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with metal synthetic
approach. substitute, cemented,
open approach.
[[Page 24392]]
0SPB48Z.................. Removal of spacer from and 0SRS01A.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with metal synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS01Z.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with metal synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS039.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with ceramic synthetic
approach. substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRS03A.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with ceramic synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS03Z.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with ceramic synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS0J9.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with synthetic
approach. substitute, cemented,
open approach.
0SPB48Z.................. Removal of spacer from and 0SRS0JA.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with synthetic
approach. substitute,
uncemented, open
approach.
0SPB48Z.................. Removal of spacer from and 0SRS0JZ.................. Replacement of left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with synthetic
approach. substitute, open
approach.
0SPB48Z.................. Removal of spacer from and 0SUB09Z.................. Supplement left hip
left hip joint, joint with liner, open
percutaneous endoscopic approach.
approach.
0SPB48Z.................. Removal of spacer from and 0SUE09Z.................. Supplement left hip
left hip joint, joint, acetabular
percutaneous endoscopic surface with liner,
approach. open approach.
0SPB48Z.................. Removal of spacer from and 0SUS09Z.................. Supplement left hip
left hip joint, joint, femoral surface
percutaneous endoscopic with liner, open
approach. approach.
0SPB4JZ.................. Removal of synthetic and 0SRB019.................. Replacement of left hip
substitute from left joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. cemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB01A.................. Replacement of left hip
substitute from left joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB01Z.................. Replacement of left hip
substitute from left joint with metal
hip joint, percutaneous synthetic substitute,
endoscopic approach. open approach.
0SPB4JZ.................. Removal of synthetic and 0SRB029.................. Replacement of left hip
substitute from left joint with metal on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRB02A.................. Replacement of left hip
substitute from left joint with metal on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB02Z.................. Replacement of left hip
substitute from left joint with metal on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB039.................. Replacement of left hip
substitute from left joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. cemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB03A.................. Replacement of left hip
substitute from left joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB03Z.................. Replacement of left hip
substitute from left joint with ceramic
hip joint, percutaneous synthetic substitute,
endoscopic approach. open approach.
0SPB4JZ.................. Removal of synthetic and 0SRB049.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRB04A.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB04Z.................. Replacement of left hip
substitute from left joint with ceramic on
hip joint, percutaneous polyethylene synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB0J9.................. Replacement of left hip
substitute from left joint with synthetic
hip joint, percutaneous substitute, cemented,
endoscopic approach. open approach.
0SPB4JZ.................. Removal of synthetic and 0SRB0JA.................. Replacement of left hip
substitute from left joint with synthetic
hip joint, percutaneous substitute,
endoscopic approach. uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRB0JZ.................. Replacement of left hip
substitute from left joint with synthetic
hip joint, percutaneous substitute, open
endoscopic approach. approach.
0SPB4JZ.................. Removal of synthetic and 0SRE009.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRE00A.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE00Z.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with
endoscopic approach. polyethylene synthetic
substitute, open
approach.
[[Page 24393]]
0SPB4JZ.................. Removal of synthetic and 0SRE019.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE01A.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE01Z.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with metal
endoscopic approach. synthetic substitute,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRE039.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
cemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE03A.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE03Z.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with ceramic
endoscopic approach. synthetic substitute,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRE0J9.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRE0JA.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRE0JZ.................. Replacement of left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS019.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with metal synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRS01A.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with metal synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS01Z.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with metal synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS039.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with ceramic synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRS03A.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with ceramic synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS03Z.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with ceramic synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS0J9.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with synthetic
endoscopic approach. substitute, cemented,
open approach.
0SPB4JZ.................. Removal of synthetic and 0SRS0JA.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with synthetic
endoscopic approach. substitute,
uncemented, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SRS0JZ.................. Replacement of left hip
substitute from left joint, femoral surface
hip joint, percutaneous with synthetic
endoscopic approach. substitute, open
approach.
0SPB4JZ.................. Removal of synthetic and 0SUB09Z.................. Supplement left hip
substitute from left joint with liner, open
hip joint, percutaneous approach.
endoscopic approach.
0SPB4JZ.................. Removal of synthetic and 0SUE09Z.................. Supplement left hip
substitute from left joint, acetabular
hip joint, percutaneous surface with liner,
endoscopic approach. open approach.
0SPB4JZ.................. Removal of synthetic and 0SUS09Z.................. Supplement left hip
substitute from left joint, femoral surface
hip joint, percutaneous with liner, open
endoscopic approach. approach
----------------------------------------------------------------------------------------------------------------
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 Code descriptions ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
0SPC09Z Removal of liner from and 0SRC0J9.................. Replacement of right
right knee joint, open knee joint with
approach. synthetic substitute,
cemented, open
approach.
0SPC09Z Removal of liner from and 0SRC0JA.................. Replacement of right
right knee joint, open knee joint with
approach. synthetic substitute,
uncemented, open
approach.
0SPC09Z Removal of liner from and 0SRC0JZ.................. Replacement of right
right knee joint, open knee joint with
approach. synthetic substitute,
open approach.
[[Page 24394]]
0SPC09Z Removal of liner from and 0SRT0J9.................. Replacement of right
right knee joint, open knee joint, femoral
approach. surface with synthetic
substitute, cemented,
open approach.
0SPC09Z Removal of liner from and 0SRT0JA.................. Replacement of right
right knee joint, open knee joint, femoral
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPC09Z Removal of liner from and 0SRT0JZ.................. Replacement of right
right knee joint, open knee joint, femoral
approach. surface with synthetic
substitute, open
approach.
0SPC09Z Removal of liner from and 0SRV0J9.................. Replacement of right
right knee joint, open knee joint, tibial
approach. surface with synthetic
substitute, cemented,
open approach.
0SPC09Z Removal of liner from and 0SRV0JA.................. Replacement of right
right knee joint, open knee joint, tibial
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPC09Z Removal of liner from and 0SRV0JZ.................. Replacement of right
right knee joint, open knee joint, tibial
approach. surface with synthetic
substitute, open
approach.
0SPC0JZ Removal of synthetic and 0SRT0J9.................. Replacement of right
substitute from right knee joint, femoral
knee joint, open surface with synthetic
approach. substitute, cemented,
open approach.
0SPC0JZ Removal of synthetic and 0SRT0JA.................. Replacement of right
substitute from right knee joint, femoral
knee joint, open surface with synthetic
approach. substitute,
uncemented, open
approach.
0SPC0JZ Removal of synthetic and 0SRV0J9.................. Replacement of right
substitute from right knee joint, tibial
knee joint, open surface with synthetic
approach. substitute, cemented,
open approach.
0SPC0JZ Removal of synthetic and 0SRV0JA.................. Replacement of right
substitute from right knee joint, tibial
knee joint, open surface with synthetic
approach. substitute,
uncemented, open
approach.
0SPC4JZ Removal of synthetic and 0SRT0J9.................. Replacement of right
substitute from right knee joint, femoral
knee joint, surface with synthetic
percutaneous endoscopic substitute, cemented,
approach. open approach.
0SPC4JZ Removal of synthetic and 0SRT0JA.................. Replacement of right
substitute from right knee joint, femoral
knee joint, surface with synthetic
percutaneous endoscopic substitute,
approach. uncemented, open
approach.
0SPC4JZ Removal of synthetic and 0SRV0J9.................. Replacement of right
substitute from right knee joint, tibial
knee joint, surface with synthetic
percutaneous endoscopic substitute, cemented,
approach. open approach.
0SPC4JZ Removal of synthetic and 0SRV0JA.................. Replacement of right
substitute from right knee joint, tibial
knee joint, surface with synthetic
percutaneous endoscopic substitute,
approach. uncemented, open
approach.
0SPD09Z Removal of liner from and 0SRD0J9.................. Replacement of left
left knee joint, open knee joint with
approach. synthetic substitute,
cemented, open
approach.
0SPD09Z Removal of liner from and 0SRD0JA.................. Replacement of left
left knee joint, open knee joint with
approach. synthetic substitute,
uncemented, open
approach.
0SPD09Z Removal of liner from and 0SRD0JZ.................. Replacement of left
left knee joint, open knee joint with
approach. synthetic substitute,
open approach.
0SPD09Z Removal of liner from and 0SRU0J9.................. Replacement of left
left knee joint, open knee joint, femoral
approach. surface with synthetic
substitute, cemented,
open approach.
0SPD09Z Removal of liner from and 0SRU0JA.................. Replacement of left
left knee joint, open knee joint, femoral
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPD09Z Removal of liner from and 0SRU0JZ.................. Replacement of left
left knee joint, open knee joint, femoral
approach. surface with synthetic
substitute, open
approach.
0SPD09Z Removal of liner from and 0SRW0J9.................. Replacement of left
left knee joint, open knee joint, tibial
approach. surface with synthetic
substitute, cemented,
open approach.
0SPD09Z Removal of liner from and 0SRW0JA.................. Replacement of left
left knee joint, open knee joint, tibial
approach. surface with synthetic
substitute,
uncemented, open
approach.
0SPD09Z Removal of liner from and 0SRW0JZ.................. Replacement of left
left knee joint, open knee joint, tibial
approach. surface with synthetic
substitute, open
approach.
0SPD0JZ Removal of synthetic and 0SRU0J9.................. Replacement of left
substitute from left knee joint, femoral
knee joint, open surface with synthetic
approach. substitute, cemented,
open approach.
0SPD0JZ Removal of synthetic and 0SRU0JA.................. Replacement of left
substitute from left knee joint, femoral
knee joint, open surface with synthetic
approach. substitute,
uncemented, open
approach.
0SPD0JZ Removal of synthetic and 0SRW0J9.................. Replacement of left
substitute from left knee joint, tibial
knee joint, open surface with synthetic
approach. substitute, cemented,
open approach.
0SPD0JZ Removal of synthetic and 0SRW0JA.................. Replacement of left
substitute from left knee joint, tibial
knee joint, open surface with synthetic
approach. substitute,
uncemented, open
approach.
[[Page 24395]]
0SPD0JZ Removal of synthetic and 0SRW0JZ.................. Replacement of left
substitute from left knee joint, tibial
knee joint, open surface with synthetic
approach. substitute, open
approach.
0SPD4JZ Removal of synthetic and 0SRU0J9.................. Replacement of left
substitute from left knee joint, femoral
knee joint, surface with synthetic
percutaneous endoscopic substitute, cemented,
approach. open approach.
0SPD4JZ Removal of synthetic and 0SRU0JA.................. Replacement of left
substitute from left knee joint, femoral
knee joint, surface with synthetic
percutaneous endoscopic substitute,
approach. uncemented, open
approach.
0SPD4JZ Removal of synthetic and 0SRW0J9.................. Replacement of left
substitute from left knee joint, tibial
knee joint, surface with synthetic
percutaneous endoscopic substitute, cemented,
approach. open approach.
0SPD4JZ Removal of synthetic and 0SRW0JA.................. Replacement of left
substitute from left knee joint, tibial
knee joint, surface with synthetic
percutaneous endoscopic substitute,
approach. uncemented, open
approach.
0SPD4JZ Removal of synthetic and 0SRW0JZ.................. Replacement of left
substitute from left knee joint, tibial
knee joint, surface with synthetic
percutaneous endoscopic substitute, open
approach. approach.
----------------------------------------------------------------------------------------------------------------
We are inviting public comments on our proposal to add the joint
revision code combinations listed above to MS-DRGs 466, 467, and 468.
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.
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
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 anti-inflammatory 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.
[[Page 24396]]
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 Code description
----------------------------------------------------------------------------------------------------------------
T63.001A.................................... Toxic effect of unspecified snake venom, accidental
(unintentional), initial encounter.
T63.011A.................................... Toxic effect of rattlesnake venom, accidental (unintentional)
initial encounter.
T63.021A.................................... Toxic effect of coral snake venom, accidental (unintentional),
initial encounter.
T63.031A.................................... Toxic effect of taipan venom, accidental (unintentional), initial
encounter.
T63.041A.................................... Toxic effect of cobra venom, accidental (unintentional), initial
encounter.
T63.061A.................................... Toxic effect of venom of other North and South American snake,
accidental (unintentional), initial encounter.
T63.71A..................................... Toxic effect of venom of other Australian snake, accidental
(unintentional), initial encounter.
T63.081A.................................... Toxic effect of venom of other African and Asian snake, accidental
(unintentional), initial encounter.
T63.091A.................................... Toxic effect of 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 Code description
----------------------------------------------------------------------------------------------------------------
T63.001A.................................... Toxic effect of unspecified snake venom, accidental
(unintentional), initial encounter.
T63.011A.................................... Toxic effect of rattlesnake venom, accidental (unintentional)
initial encounter.
T63.021A.................................... Toxic effect of coral snake venom, accidental (unintentional),
initial encounter.
T63.031A.................................... Toxic effect of taipan venom, accidental (unintentional), initial
encounter.
T63.041A.................................... Toxic effect of cobra venom, accidental (unintentional), initial
encounter.
T63.061A.................................... Toxic effect of venom of other North and South American snake,
accidental (unintentional), initial encounter.
T63.71A..................................... Toxic effect of venom of other Australian snake, accidental
(unintentional), initial encounter.
T63.081A.................................... Toxic effect of venom of other African and Asian snake, accidental
(unintentional), initial encounter.
T63.091A.................................... Toxic effect of 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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 917--All cases........................................... 26,393 4.77 $9,983
MS-DRG 917--Cases with principal diagnosis code 989.5 and 0 0 0
secondary diagnosis code E905.0 with procedure code 99.16 (non-
OR)............................................................
MS-DRG 918--All cases........................................... 24,557 2.90 4,953
MS-DRG 918--Cases with principal diagnosis code 989.5 and 19 2.16 12,014
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
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 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
[[Page 24397]]
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:
http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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 Average
MS-DRG cases length of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 927--All cases........................................... 171 29.92 $113,844
MS-DRG 927--Cases with procedure code 86.67..................... 22 33.5 146,903
MS-DRG 927--Cases with procedure code 86.67 and 96.72 14 38.6 174,372
(Mechanical ventilation for 96+ hours).........................
MS-DRG 927--Cases with procedure code 86.67 and without 96.72 8 24.6 98,482
(Mechanical ventilation for 96+ hours).........................
MS-DRG 927--All cases with MCC.................................. 131 31.51 121,519
MS-DRG 927--All cases with CC................................... 38 25.21 91,910
MS-DRG 927--All cases without CC/MCC............................ 2 15.00 27,872
----------------------------------------------------------------------------------------------------------------
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 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.
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: http://www.cms.gov/
[[Page 24398]]
Medicare/Coding/ICD10/ICD-10-MS-DRG-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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-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...................................... Myelofibrosis.
E08.00...................................... Diabetes mellitus due to underlying condition with hyperosmolarity
without nonketotic hyperglycemic-hyperosmolar coma (NKHHC).
E08.01...................................... Diabetes mellitus due to underlying condition with hyperosmolarity
with coma.
E08.10...................................... Diabetes mellitus due to underlying condition with ketoacidosis
without coma.
E08.11...................................... Diabetes mellitus due to underlying condition with ketoacidosis
with coma.
E08.21...................................... Diabetes mellitus due to underlying condition with diabetic
nephropathy.
E08.22...................................... Diabetes mellitus due to underlying condition with diabetic
chronic kidney disease.
E08.29...................................... Diabetes mellitus due to underlying condition with other diabetic
kidney complication.
E08.311..................................... Diabetes mellitus due to underlying condition with unspecified
diabetic retinopathy with macular edema.
E08.319..................................... Diabetes mellitus due to underlying condition with unspecified
diabetic retinopathy without macular edema.
E08.321..................................... Diabetes mellitus due to underlying condition with mild
nonproliferative diabetic retinopathy with macular edema.
E08.329..................................... Diabetes mellitus due to underlying condition with mild
nonproliferative diabetic retinopathy without macular edema.
E08.331..................................... Diabetes mellitus due to underlying condition with moderate
nonproliferative diabetic retinopathy with macular edema.
E08.339..................................... Diabetes mellitus due to underlying condition with moderate
nonproliferative diabetic retinopathy without macular edema.
E08.341..................................... Diabetes mellitus due to underlying condition with severe
nonproliferative diabetic retinopathy with macular edema.
E08.349..................................... Diabetes mellitus due to underlying condition with severe
nonproliferative diabetic retinopathy without macular edema.
E08.351..................................... Diabetes mellitus due to underlying condition with proliferative
diabetic retinopathy with macular edema.
E08.359..................................... Diabetes mellitus due to underlying condition with proliferative
diabetic retinopathy without macular edema.
E08.36...................................... Diabetes mellitus due to underlying condition with diabetic
cataract.
E08.39...................................... Diabetes mellitus due to underlying condition with other diabetic
ophthalmic complication.
E08.40...................................... Diabetes mellitus due to underlying condition with diabetic
neuropathy, unspecified.
E08.41...................................... Diabetes mellitus due to underlying condition with diabetic
mononeuropathy.
E08.42...................................... Diabetes mellitus due to underlying condition with diabetic
polyneuropathy.
E08.43...................................... Diabetes mellitus due to underlying condition with diabetic
autonomic (poly)neuropathy.
E08.44...................................... Diabetes mellitus due to underlying condition with diabetic
amyotrophy.
E08.49...................................... Diabetes mellitus due to underlying condition with other diabetic
neurological complication.
E08.51...................................... Diabetes mellitus due to underlying condition with diabetic
peripheral angiopathy without gangrene.
E08.52...................................... Diabetes mellitus due to underlying condition with diabetic
peripheral angiopathy with gangrene.
E08.59...................................... Diabetes mellitus due to underlying condition with other
circulatory complications.
E08.610..................................... Diabetes mellitus due to underlying condition with diabetic
neuropathic arthropathy.
E08.618..................................... Diabetes mellitus due to underlying condition with other diabetic
arthropathy.
E08.620..................................... Diabetes mellitus due to underlying condition with diabetic
dermatitis.
E08.621..................................... Diabetes mellitus due to underlying condition with foot ulcer.
E08.622..................................... Diabetes mellitus due to underlying condition with other skin
ulcer.
E08.628..................................... Diabetes mellitus due to underlying condition with other skin
complications.
E08.630..................................... Diabetes mellitus due to underlying condition with periodontal
disease.
E08.638..................................... Diabetes mellitus due to underlying condition with other oral
complications.
E08.641..................................... Diabetes mellitus due to underlying condition with hypoglycemia
with coma.
E08.649..................................... Diabetes mellitus due to underlying condition with hypoglycemia
without coma.
E08.65...................................... Diabetes mellitus due to underlying condition with hyperglycemia.
E08.69...................................... Diabetes mellitus due to underlying condition with other specified
complication.
E08.8....................................... Diabetes mellitus due to underlying condition with unspecified
complications.
E08.9....................................... Diabetes mellitus due to underlying condition without
complications.
----------------------------------------------------------------------------------------------------------------
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.
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), 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
[[Page 24399]]
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 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 lower-weighted 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 higher-
ordered 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 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html 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,
[[Page 24400]]
respectively), and the FY 2015 IPPS/LTCH PPS proposed rule and final
rule (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 MedPAR file for ICD-9-CM diagnosis codes 414.2 and 414.4. The
following table shows our findings.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cnt 1 Cnt 2 Cnt 3
SDX SDX description CC level Cnt 1 impact Cnt 2 impact Cnt 3 impact
--------------------------------------------------------------------------------------------------------------------------------------------------------
414.2............................... Chronic total occlusion Non-CC 14,655 1.393 21,222 2.098 20,615 3.046
of coronary artery.
414.4............................... Coronary Non-CC 1,752 1.412 3,238 2.148 3,244 3.053
atherosclerosis due to
calcified coronary
lesion.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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 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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-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
[[Page 24401]]
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 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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 (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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
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
[[Page 24402]]
Exclusions List, is available via the Internet on the CMS Web site at:
http://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
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);
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
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
[[Page 24403]]
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-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
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
03LG0BZ..................................... Occlusion of intracranial artery with bioactive intraluminal
device, open approach.
03LG0DZ..................................... Occlusion of intracranial artery with intraluminal device, open
approach.
03LG3BZ..................................... Occlusion of intracranial artery with bioactive intraluminal
device, percutaneous approach.
03LG3DZ..................................... Occlusion of intracranial artery with intraluminal device,
percutaneous approach.
03LG4BZ..................................... Occlusion of intracranial artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LG4DZ..................................... Occlusion of intracranial artery with intraluminal device,
percutaneous endoscopic approach.
03LH0BZ..................................... Occlusion of right common carotid artery with bioactive
intraluminal device, open approach.
03LH0DZ..................................... Occlusion of right common carotid artery with intraluminal device,
open approach.
03LH3BZ..................................... Occlusion of right common carotid artery with bioactive
intraluminal device, percutaneous approach.
03LH3DZ..................................... Occlusion of right common carotid artery with intraluminal device,
percutaneous approach.
03LH4BZ..................................... Occlusion of right common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LH4DZ..................................... Occlusion of right common carotid artery with intraluminal device,
percutaneous endoscopic approach.
03LJ0BZ..................................... Occlusion of left common carotid artery with bioactive
intraluminal device, open approach.
03LJ0DZ..................................... Occlusion of left common carotid artery with intraluminal device,
open approach.
03LJ3BZ..................................... Occlusion of left common carotid artery with bioactive
intraluminal device, percutaneous approach.
03LJ3DZ..................................... Occlusion of left common carotid artery with intraluminal device,
percutaneous approach.
03LJ4BZ..................................... Occlusion of left common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LJ4DZ..................................... Occlusion of left common carotid artery with intraluminal device,
percutaneous endoscopic approach.
03LK0BZ..................................... Occlusion of right internal carotid artery with bioactive
intraluminal device, open approach.
03LK0DZ..................................... Occlusion of right internal carotid artery with intraluminal
device, open approach.
03LK3BZ..................................... Occlusion of right internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03LK3DZ..................................... Occlusion of right internal carotid artery with intraluminal
device, percutaneous approach.
03LK4BZ..................................... Occlusion of right internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LK4DZ..................................... Occlusion of right internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LL0BZ..................................... Occlusion of left internal carotid artery with bioactive
intraluminal device, open approach.
03LL0DZ..................................... Occlusion of left internal carotid artery with intraluminal
device, open approach.
03LL3BZ..................................... Occlusion of left internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03LL3DZ..................................... Occlusion of left internal carotid artery with intraluminal
device, percutaneous approach.
03LL4BZ..................................... Occlusion of left internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LL4DZ..................................... Occlusion of left internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LM0BZ..................................... Occlusion of right external carotid artery with bioactive
intraluminal device, open approach.
03LM0DZ..................................... Occlusion of right external carotid artery with intraluminal
device, open approach.
03LM3BZ..................................... Occlusion of right external carotid artery with bioactive
intraluminal device, percutaneous approach.
03LM3DZ..................................... Occlusion of right external carotid artery with intraluminal
device, percutaneous approach.
03LM4BZ..................................... Occlusion of right external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LM4DZ..................................... Occlusion of right external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LN0BZ..................................... Occlusion of left external carotid artery with bioactive
intraluminal device, open approach.
03LN0DZ..................................... Occlusion of left external carotid artery with intraluminal
device, open approach.
03LN3BZ..................................... Occlusion of left external carotid artery with bioactive
intraluminal device, percutaneous approach.
03LN3DZ..................................... Occlusion of left external carotid artery with intraluminal
device, percutaneous approach.
03LN4BZ..................................... Occlusion of left external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03LN4DZ..................................... Occlusion of left external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03LP0BZ..................................... Occlusion of right vertebral artery with bioactive intraluminal
device, open approach.
03LP0DZ..................................... Occlusion of right vertebral artery with intraluminal device, open
approach.
[[Page 24404]]
03LP3BZ..................................... Occlusion of right vertebral artery with bioactive intraluminal
device, percutaneous approach.
03LP3DZ..................................... Occlusion of right vertebral artery with intraluminal device,
percutaneous approach.
03LP4BZ..................................... Occlusion of right vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LP4DZ..................................... Occlusion of right vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03LQ0BZ..................................... Occlusion of left vertebral artery with bioactive intraluminal
device, open approach.
03LQ0DZ..................................... Occlusion of left vertebral artery with intraluminal device, open
approach.
03LQ3BZ..................................... Occlusion of left vertebral artery with bioactive intraluminal
device, percutaneous approach.
03LQ3DZ..................................... Occlusion of left vertebral artery with intraluminal device,
percutaneous approach.
03LQ4BZ..................................... Occlusion of left vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03LQ4DZ..................................... Occlusion of left vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03VG0BZ..................................... Restriction of intracranial artery with bioactive intraluminal
device, open approach.
03VG0DZ..................................... Restriction of intracranial artery with intraluminal device, open
approach.
03VG3BZ..................................... Restriction of intracranial artery with bioactive intraluminal
device, percutaneous approach.
03VG3DZ..................................... Restriction of intracranial artery with intraluminal device,
percutaneous approach.
03VG4BZ..................................... Restriction of intracranial artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VG4DZ..................................... Restriction of intracranial artery with intraluminal device,
percutaneous endoscopic approach.
03VH0BZ..................................... Restriction of right common carotid artery with bioactive
intraluminal device, open approach.
03VH0DZ..................................... Restriction of right common carotid artery with intraluminal
device, open approach.
03VH3BZ..................................... Restriction of right common carotid artery with bioactive
intraluminal device, percutaneous approach.
03VH3DZ..................................... Restriction of right common carotid artery with intraluminal
device, percutaneous approach.
03VH4BZ..................................... Restriction of right common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VH4DZ..................................... Restriction of right common carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VJ0BZ..................................... Restriction of left common carotid artery with bioactive
intraluminal device, open approach.
03VJ0DZ..................................... Restriction of left common carotid artery with intraluminal
device, open approach.
03VJ3BZ..................................... Restriction of left common carotid artery with bioactive
intraluminal device, percutaneous approach.
03VJ3DZ..................................... Restriction of left common carotid artery with intraluminal
device, percutaneous approach.
03VJ4BZ..................................... Restriction of left common carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VJ4DZ..................................... Restriction of left common carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VK0BZ..................................... Restriction of right internal carotid artery with bioactive
intraluminal device, open approach.
03VK0DZ..................................... Restriction of right internal carotid artery with intraluminal
device, open approach.
03VK3BZ..................................... Restriction of right internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03VK3DZ..................................... Restriction of right internal carotid artery with intraluminal
device, percutaneous approach.
03VK4BZ..................................... Restriction of right internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VK4DZ..................................... Restriction of right internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VL0BZ..................................... Restriction of left internal carotid artery with bioactive
intraluminal device, open approach.
03VL0DZ..................................... Restriction of left internal carotid artery with intraluminal
device, open approach.
03VL3BZ..................................... Restriction of left internal carotid artery with bioactive
intraluminal device, percutaneous approach.
03VL3DZ..................................... Restriction of left internal carotid artery with intraluminal
device, percutaneous approach.
03VL4BZ..................................... Restriction of left internal carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VL4DZ..................................... Restriction of left internal carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VM0BZ..................................... Restriction of right external carotid artery with bioactive
intraluminal device, open approach.
03VM0DZ..................................... Restriction of right external carotid artery with intraluminal
device, open approach.
03VM3BZ..................................... Restriction of right external carotid artery with bioactive
intraluminal device, percutaneous approach.
03VM3DZ..................................... Restriction of right external carotid artery with intraluminal
device, percutaneous approach.
03VM4BZ..................................... Restriction of right external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VM4DZ..................................... Restriction of right external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VN0BZ..................................... Restriction of left external carotid artery with bioactive
intraluminal device, open approach.
03VN0DZ..................................... Restriction of left external carotid artery with intraluminal
device, open approach.
03VN3BZ..................................... Restriction of left external carotid artery with bioactive
intraluminal device, percutaneous approach.
03VN3DZ..................................... Restriction of left external carotid artery with intraluminal
device, percutaneous approach.
03VN4BZ..................................... Restriction of left external carotid artery with bioactive
intraluminal device, percutaneous endoscopic approach.
03VN4DZ..................................... Restriction of left external carotid artery with intraluminal
device, percutaneous endoscopic approach.
03VP0BZ..................................... Restriction of right vertebral artery with bioactive intraluminal
device, open approach.
03VP0DZ..................................... Restriction of right vertebral artery with intraluminal device,
open approach.
03VP3BZ..................................... Restriction of right vertebral artery with bioactive intraluminal
device, percutaneous approach.
03VP3DZ..................................... Restriction of right vertebral artery with intraluminal device,
percutaneous approach.
03VP4BZ..................................... Restriction of right vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VP4DZ..................................... Restriction of right vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03VQ0BZ..................................... Restriction of left vertebral artery with bioactive intraluminal
device, open approach.
03VQ0DZ..................................... Restriction of left vertebral artery with intraluminal device,
open approach.
03VQ3BZ..................................... Restriction of left vertebral artery with bioactive intraluminal
device, percutaneous approach.
03VQ3DZ..................................... Restriction of left vertebral artery with intraluminal device,
percutaneous approach.
03VQ4BZ..................................... Restriction of left vertebral artery with bioactive intraluminal
device, percutaneous endoscopic approach.
03VQ4DZ..................................... Restriction of left vertebral artery with intraluminal device,
percutaneous endoscopic approach.
03VR0DZ..................................... Restriction of face artery with intraluminal device, open
approach.
03VR3DZ..................................... Restriction of face artery with intraluminal device, percutaneous
approach.
03VR4DZ..................................... Restriction of face artery with intraluminal device, percutaneous
endoscopic approach.
03VS0DZ..................................... Restriction of right temporal artery with intraluminal device,
open approach.
03VS3DZ..................................... Restriction of right temporal artery with intraluminal device,
percutaneous approach.
03VS4DZ..................................... Restriction of right temporal artery with intraluminal device,
percutaneous endoscopic approach.
03VT0DZ..................................... Restriction of left temporal artery with intraluminal device, open
approach.
[[Page 24405]]
03VT3DZ..................................... Restriction of left temporal artery with intraluminal device,
percutaneous approach.
03VT4DZ..................................... Restriction of left temporal artery with intraluminal device,
percutaneous endoscopic approach.
03VU0DZ..................................... Restriction of right thyroid artery with intraluminal device, open
approach.
03VU3DZ..................................... Restriction of right thyroid artery with intraluminal device,
percutaneous approach.
03VU4DZ..................................... Restriction of right thyroid artery with intraluminal device,
percutaneous endoscopic approach.
03VV0DZ..................................... Restriction of left thyroid artery with intraluminal device, open
approach.
03VV3DZ..................................... Restriction of left thyroid artery with intraluminal device,
percutaneous approach.
03VV4DZ..................................... Restriction of 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
----------------------------------------------------------------------------------------------------------------
Average
MS-DRG Number of length of Average costs
cases stay
----------------------------------------------------------------------------------------------------------------
MS-DRG 981--All cases........................................... 21,118 12.38 $33,080
MS-DRG 981--Epistaxis cases with principal diagnosis code 784.7 8 6.50 34,655
and procedure code 39.75.......................................
MS-DRG 981--Epistaxis cases with principal diagnosis code 784.7 2 12.50 50,081
and procedure code 39.76.......................................
MS-DRG 982--All cases........................................... 13,657 7.14 19,392
MS-DRG 982--Epistaxis cases with principal diagnosis code 784.7 22 3.14 17,725
and procedure code 39.75.......................................
MS-DRG 982--Epistaxis cases with principal diagnosis code 784.7 2 2.0 11,010
and procedure code 39.76.......................................
MS-DRG 983--All cases........................................... 2,989 3.60 12,760
MS-DRG 983--Epistaxis cases with principal diagnosis code 784.7 5 2.60 10,532
and procedure code 39.75.......................................
MS-DRG 983--Epistaxis cases with principal diagnosis code 784.7 4 1.50 16,658
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 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.
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
[[Page 24406]]
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 non-Federal
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: http://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: http://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 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: http://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: http://www.cdc.gov/nchs/icd/icd9cm-maintenance.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, Co-Chairperson, ICD-10
Coordination and Maintenance Committee, NCHS, Room 2402, 3311 Toledo
Road, Hyattsville, MD 20782. Comments may be sent by Email to:
[email protected].
Questions and comments concerning the procedure codes should be
addressed to: Patricia Brooks, Co-Chairperson, 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: [email protected].
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.
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
[[Page 24407]]
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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/
icd9ProviderDiagnosticCodes/01overview.asp#TopofPage. ICD-10-CM and
ICD-10-PCS addendum and code title information is published on the CMS
Web site at http://www.cms.gov/Medicare/Coding/ICD10/index.html.
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:
http://www.cdc.gov/nchs/index.html. 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 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: http://www.cms.gov/Medicare/Coding/ICD10/ICD-9-CM-Coordination-and-Maintenance-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: http://www.thefederalregister.org/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.
[[Page 24408]]
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: http://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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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 ICD-10-CM and ICD-10-PCS Codes
----------------------------------------------------------------------------------------------------------------
Fiscal Year Number Change Fiscal Year Number Change
----------------------------------------------------------------------------------------------------------------
FY 2009 (October 1, 2008): ........... ............ FY 2009:
Diagnoses...................... 14,025 348 ICD-10-CM.......... 68,069 +5
Procedures..................... 3,824 56 ICD-10-PCS......... 72,589 -14,327
FY 2010 (October 1, 2009): ........... ............ FY 2010:
Diagnoses...................... 14,315 290 ICD-10-CM.......... 69,099 +1,030
Procedures..................... 3,838 14 ICD-10-PCS......... 71,957 -632
FY 2011(October 1, 2010):
Diagnoses...................... 14,432 117 ICD-10-CM.......... 69,368 +269
Procedures..................... 3,859 21 ICD-10-PCS......... 72,081 +124
FY 2012 (October 1, 2011): ........... ............ FY 2012:
Diagnoses...................... 14,567 135 ICD-10-CM.......... 69,833 +465
Procedures..................... 3,877 18 ICD-10-PCS......... 71,918 -163
FY 2013 (October 1, 2012): ........... ............ FY 2013:
Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,832 -1
Procedures..................... 3,878 1 ICD-10-PCS......... 71,920 +2
FY 2014 (October 1, 2013): ........... ............ FY 2014:
Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 -9
Procedures..................... 3,882 4 ICD-10-PCS......... 71,924 +4
FY 2015 (October 1, 2014): ........... ............ FY 2015:
Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 0
Procedures..................... 3,882 0 ICD-10-PCS......... 71,924 0
FY 2016 (October 1, 2015): ........... ............ FY 2016:
Diagnoses...................... 14,567 0 ICD-10-CM.......... 69,823 0
Procedures..................... 3,882 0 ICD-10-PCS......... 71,962 +38
----------------------------------------------------------------------------------------------------------------
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-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 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
[[Page 24409]]
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 ``device-dependent'' 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 ``device-dependent'' 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 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
------------------------------------------------------------------------
MDC MS-DRG MS-DRG Title
------------------------------------------------------------------------
PreMDC............ 001..... Heart Transplant or Implant of Heart
Assist System with MCC.
PreMDC............ 002..... Heart Transplant or Implant of Heart
Assist System without MCC.
MDC 01............ 023..... Craniotomy with Major Device Implant/Acute
Complex CNS PDX with MCC or Chemo
Implant.
MDC 01............ 024..... Craniotomy with Major Device Implant/Acute
Complex CNS PDX without MCC.
MDC 01............ 025..... Craniotomy & Endovascular Intracranial
Procedures with MCC.
MDC 01............ 026..... Craniotomy & Endovascular Intracranial
Procedures with CC.
MDC 01............ 027..... Craniotomy & Endovascular Intracranial
Procedures without CC/MCC.
MDC 01............ 040..... Peripheral/Cranial Nerve & Other Nervous
System Procedures with MCC.
MDC 01............ 041..... Peripheral/Cranial Nerve & Other Nervous
System Procedures with CC or Peripheral
Neurostimulation.
MDC 01............ 042..... Peripheral/Cranial Nerve & Other Nervous
System Procedures without CC/MCC.
MDC 03............ 129..... Major Head & Neck Procedures with CC/MCC
or Major Device.
MDC 03............ 130..... Major Head & Neck Procedures without CC/
MCC.
MDC 05............ 215..... Other Heart Assist System Implant.
MDC 05............ 216..... Cardiac Valve & Other Major Cardiothoracic
Procedures with Cardiac Catheterization
with MCC.
MDC 05............ 217..... Cardiac Valve & Other Major Cardiothoracic
Procedures with Cardiac Catheterization
with CC.
MDC 05............ 218..... Cardiac Valve & Other Major Cardiothoracic
Procedures with Cardiac Catheterization
without CC/MCC.
MDC 05............ 219..... Cardiac Valve & Other Major Cardiothoracic
Procedures without Cardiac
Catheterization with MCC.
MDC 05............ 220..... Cardiac Valve & Other Major Cardiothoracic
Procedures without Cardiac
Catheterization with CC.
MDC 05............ 221..... Cardiac Valve & Other Major Cardiothoracic
Procedures without Cardiac
Catheterization without CC/MCC.
MDC 05............ 222..... Cardiac Defibrillator Implant with Cardiac
Catheterization with AMI/HF/Shock with
MCC.
MDC 05............ 223..... Cardiac Defibrillator Implant with Cardiac
Catheterization with AMI/HF/Shock without
MCC.
MDC 05............ 224..... Cardiac Defibrillator Implant with Cardiac
Catheterization without AMI/HF/Shock with
MCC.
MDC 05............ 225..... Cardiac Defibrillator Implant with Cardiac
Catheterization without AMI/HF/Shock
without MCC.
MDC 05............ 226..... Cardiac Defibrillator Implant without
Cardiac Catheterization with MCC.
MDC 05............ 227..... Cardiac Defibrillator Implant without
Cardiac Catheterization without MCC.
MDC 05............ 242..... Permanent Cardiac Pacemaker Implant with
MCC.
MDC 05............ 243..... Permanent Cardiac Pacemaker Implant with
CC.
MDC 05............ 244..... Permanent Cardiac Pacemaker Implant
without CC/MCC.
MDC 05............ 245..... AICD Generator Procedures.
MDC 05............ 258..... Cardiac Pacemaker Device Replacement with
MCC.
[[Page 24410]]
MDC 05............ 259..... Cardiac Pacemaker Device Replacement
without MCC.
MDC 05............ 260..... Cardiac Pacemaker Revision Except Device
Replacement with MCC.
MDC 05............ 261..... Cardiac Pacemaker Revision Except Device
Replacement with CC.
MDC 05............ 262..... Cardiac Pacemaker Revision Except Device
Replacement without CC/MCC.
MDC 05............ 265..... AICD Lead Procedures.
MDC 05............ 266..... Endovascular Cardiac Valve Replacement
with MCC.
MDC 05............ 267..... Endovascular Cardiac Valve Replacement
without MCC.
MDC 05............ 268..... Aortic and Heart Assist Procedures Except
Pulsation Balloon with MCC.
MDC 05............ 269..... Aortic and Heart Assist Procedures Except
Pulsation Balloon without MCC.
MDC 05............ 270..... Other Major Cardiovascular Procedures with
MCC.
MDC 05............ 271..... Other Major Cardiovascular Procedures with
CC.
MDC 05............ 272..... Other Major Cardiovascular Procedures
without CC/MCC.
MDC 08............ 461..... Bilateral or Multiple Major Joint
Procedures of Lower Extremity with MCC.
MDC 08............ 462..... Bilateral or Multiple Major Joint
Procedures of Lower Extremity without
MCC.
MDC 08............ 466..... Revision of Hip or Knee Replacement with
MCC.
MDC 08............ 467..... Revision of Hip or Knee Replacement with
CC.
MDC 08............ 468..... Revision of Hip or Knee Replacement
without CC/MCC.
MDC 08............ 469..... Major Joint Replacement or Reattachment of
Lower Extremity with MCC.
MDC 08............ 470..... 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).
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 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 cost-based
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 cost-based relative weights.
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 Medicare-approved 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
[[Page 24411]]
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 (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 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: http://innovation.cms.gov/initiatives/Bundled-Payments/index.html 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-of-living 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.
[[Page 24412]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost from HCRIS Charges from HCRIS
Revenue codes (Worksheet C, Part 1, (Worksheet C, Part 1, Medicare charges from
Cost center group name (19 MedPAR charge contained in Cost report line Column 5 and line Column 6 & 7 and HCRIS (Worksheet D-3,
total) field MedPAR charge description number) Form CMS-2552- line number) Form Column & line number)
field 10 CMS-2552-10 Form CMS-2552-10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Routine Days................. Private Room 011X and 014X... Adults & C_1_C5_30............ C_1_C6_30............ D3_HOS_C2_30
Charges. Pediatrics
(General
Routine Care).
Semi-Private 012X, 013X and ................ ..................... ..................... .....................
Room Charges. 016X-019X.
Ward Charges.... 015X............ ................ ..................... ..................... .....................
Intensive Days............... Intensive Care 020X............ Intensive Care C_1_C5_31............ C_1_C6_31............ D3_HOS_C2_31
Charges. Unit.
Coronary Care 021X............ Coronary Care C_1_C5_32............ C_1_C6_32............ D3_HOS_C2_32
Charges. Unit.
Burn Intensive C_1_C5_33............ C_1_C6_33............ D3_HOS_C2_33
Care Unit.
Surgical C_1_C5_34............ C_1_C6_34............ D3_HOS_C2_34
Intensive Care
Unit.
Other Special C_1_C5_35............ C_1_C6_35............ D3_HOS_C2_35
Care Unit.
Drugs........................ Pharmacy Charges 025X, 026X and Intravenous C_1_C5_64............ C_1_C6_64............ D3_HOS_C2_64
063X. Therapy. C_1_C7_64............
Drugs Charged To C_1_C5_73............ C_1_C6_73............ D3_HOS_C2_73
Patient. C_1_C7_73............
Supplies and Equipment....... Medical/Surgical 0270, 0271, Medical Supplies C_1_C5_71............ C_1_C6_71............ D3_HOS_C2_71
Supply Charges. 0272, 0273, Charged to C_1_C7_71............
0274, 0277, Patients.
0279, and 0621,
0622, 0623.
Durable Medical 0290, 0291, 0292 DME-Rented...... C_1_C5_96............ C_1_C6_96............ D3_HOS_C2_96
Equipment and 0294-0299. C_1_C7_96............
Charges.
Used Durable 0293............ DME-Sold........ C_1_C5_97............ C_1_C6_97............ D3_HOS_C2_97
Medical Charges. C_1_C7_97............
Implantable Devices.......... 0275, 0276, Implantable C_1_C5_72............ C_1_C6_72............ D3_HOS_C2_72
0278, 0624. Devices Charged C_1_C7_72............
to Patients.
Therapy Services............. Physical Therapy 042X............ Physical Therapy C_1_C5_66............ C_1_C6_66............ D3_HOS_C2_66
Charges. C_1_C7_66............
Occupational 043X............ Occupational C_1_C5_67............ C_1_C6_67............ D3_HOS_C2_67
Therapy Charges. Therapy. C_1_C7_67............
Speech Pathology 044X and 047X... Speech Pathology C_1_C5_68............ C_1_C6_68............ D3_HOS_C2_68
Charges. C_1_C7_68............
Inhalation Therapy........... Inhalation 041X and 046X... Respiratory C_1_C5_65............ C_1_C6_65............ D3_HOS_C2_65
Therapy Charges. Therapy. C_1_C7_65............
Operating Room............... Operating Room 036X............ Operating Room.. C_1_C5_50............ C_1_C6_50............ D3_HOS_C2_50
Charges. C_1_C7_50............
071X............ Recovery Room... C_1_C5_51............ C_1_C6_51............ D3_HOS_C2_51
C_1_C7_51 .....................
Labor & Delivery............. Operating Room 072X............ Delivery Room C_1_C5_52............ C_1_C6_52............ D3_HOS_C2_52
Charges. and Labor Room. C_1_C7_52............
Anesthesia................... Anesthesia 037X............ Anesthesiology.. C_1_C5_53............ C_1_C6_53............ D3_HOS_C2_53
Charges.
C_1_C7_53 .....................
Cardiology................... Cardiology 048X and 073X... Electro- C_1_C5_69............ C_1_C6_69............ D3_HOS_C2_69
Charges. cardiology.
C_1_C7_69 .....................
Cardiac Catheterization...... 0481............ Cardiac C_1_C5_59............ C_1_C6_59............ D3_HOS_C2_59
Catheterization. C_1_C7_59............
Laboratory................... Laboratory 030X, 031X, and Laboratory...... C_1_C5_60............ C_1_C6_60............ D3_HOS_C2_60
Charges. 075X. C_1_C7_60............
PBP Clinic C_1_C5_61............ C_1_C6_61............ D3_HOS_C2_61
Laboratory C_1_C7_61............
Services.
074X, 086X...... Electro- C_1_C5_70............ C_1_C6_70............ D3_HOS_C2_70
Encephalography. C_1_C7_70............
Radiology.................... Radiology 032X, 040X...... Radiology--Diagn C_1_C5_54............ C_1_C6_54............ D3_HOS_C2_54
Charges. ostic. C_1_C7_54............
028X, 0331, Radiology--Thera C_1_C5_55............ C_1_C6_55............ D3_HOS_C2_55
0332, 0333, peutic.
0335, 0339,
0342.
0343 and 344.... Radioisotope.... C_1_C5_56............ C_1_C6_56............ D3_HOS_C2_56
C_1_C7_56............
Computed Tomography (CT) Scan CT Scan Charges. 035X............ Computed C_1_C5_57............ C_1_C6_57............ D3_HOS_C2_57
Tomography (CT) C_1_C7_57............
Scan.
[[Page 24413]]
Magnetic Resonance Imaging MRI Charges..... 061X............ Magnetic C_1_C5_58............ C_1_C6_58............ D3_HOS_C2_58
(MRI). Resonance C_1_C7_58............
Imaging (MRI).
Emergency Room............... Emergency Room 045X............ Emergency....... C_1_C5_91............ C_1_C6_91............ D3_HOS_C2_91
Charges. C_1_C7_91............
Blood and Blood Products..... Blood Charges... 038X............ Whole Blood & C_1_C5_62............ C_1_C6_62............ D3_HOS_C2_62
Packed Red C_1_C7_62............
Blood Cells.
Blood Storage/ 039X............ Blood Storing, C_1_C5_63............ C_1_C6_63............ D3_HOS_C2_63
Processing. Processing, & C_1_C7_63............
Transfusing.
Other Services............... Other Service 0002-0099, 022X, ................ ..................... ..................... .....................
Charge. 023X,
024X,052X,053X.
055X-060X, 064X- ................ ..................... ..................... .....................
070X, 076X-
078X, 090X-095X
and 099X.
Renal Dialysis.. 0800X........... Renal Dialysis.. C_1_C5_74............ C_1_C6_74............ D3_HOS_C2_74
ESRD Revenue 080X and 082X- ................ ..................... C_1_C7_74 .....................
Setting Charges. 088X.
Home Program C_1_C5_94............ C_1_C6_94............ D3_HOS_C2_94
Dialysis. C_1_C7_94............
Outpatient 049X............ ASC (Non C_1_C5_75............ C_1_C6_75............ D3_HOS_C2_75
Service Charges. Distinct Part).
Lithotripsy 079X............ ................ ..................... C_1_C7_75 .....................
Charge.
Other Ancillary. C_1_C5_76............ C_1_C6_76............ D3_HOS_C2_76
C_1_C7_76............
Clinic Visit 051X............ Clinic.......... C_1_C5_90............ C_1_C6_90............ D3_HOS_C2_90
Charges. C_1_C7_90............
Observation beds C_1_C5_92.01......... C_1_C6_92.01......... D3_HOS_C2_92.01
C_1_C7_92.01.........
Professional 096X, 097X, and Other Outpatient C_1_C5_93............ C_1_C6_93............ D3_HOS_C2_93
Fees Charges. 098X. Services. C_1_C7_93............
Ambulance 054X............ Ambulance....... C_1_C5_95............ C_1_C6_95............ D3_HOS_C2_95
Charges. C_1_C7_95............
Rural Health C_1_C5_88............ C_1_C6_88............ D3_HOS_C2_88
Clinic. C_1_C7_88............
FQHC............ C_1_C5_89............ C_1_C6_89............ D3_HOS_C2_89
C_1_C7_89............
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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 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
Medicare-specific 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 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
[[Page 24414]]
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 CCR
------------------------------------------------------------------------
Routine Days................................................... 0.485
Intensive Days................................................. 0.399
Drugs.......................................................... 0.192
Supplies & Equipment........................................... 0.299
Implantable Devices............................................ 0.344
Therapy Services............................................... 0.335
Laboratory..................................................... 0.125
Operating Room................................................. 0.201
Cardiology..................................................... 0.119
Cardiac Catheterization........................................ 0.125
Radiology...................................................... 0.159
MRIs........................................................... 0.085
CT Scans....................................................... 0.041
Emergency Room................................................. 0.184
Blood and Blood Products....................................... 0.340
Other Services................................................. 0.367
Labor & Delivery............................................... 0.404
Inhalation Therapy............................................. 0.178
Anesthesia..................................................... 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 relative weights for FY
2016. Using data from the FY 2014 MedPAR file, there were 8 MS-DRGs
that contain fewer than 10 cases. Under the MS-DRGs, we have fewer low-
volume DRGs than under the CMS DRGs because we no longer have separate
DRGs for patients aged 0 to 17 years. With the exception of newborns,
we previously separated some DRGs based on whether the patient was age
0 to 17 years or age 17 years and older. Other than the age split,
cases grouping to these DRGs are identical. The DRGs for patients aged
0 to 17 years generally have very low volumes because children are
typically ineligible for Medicare. In the past, we 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:
------------------------------------------------------------------------
Low-volume MS-DRG MS-DRG Title Crosswalk to MS-DRG
------------------------------------------------------------------------
768................... Vaginal Delivery with Final FY 2015 relative
O.R. Procedure weight (adjusted by
Except Sterilization percent change in
and/or D&C. average weight of the
cases in other
MS[dash]DRGs).
789................... Neonates, Died or Final FY 2015 relative
Transferred to weight (adjusted by
Another Acute Care percent change in
Facility. average weight of the
cases in other
MS[dash]DRGs).
790................... Extreme Immaturity or Final FY 2015 relative
Respiratory Distress weight (adjusted by
Syndrome, Neonate. percent change in
average weight of the
cases in other
MS[dash]DRGs).
791................... Prematurity with Final FY 2015 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other
MS[dash]DRGs).
792................... Prematurity without Final FY 2015 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other
MS[dash]DRGs).
793................... Full-Term Neonate Final FY 2015 relative
with Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other
MS[dash]DRGs).
794................... Neonate with Other Final FY 2015 relative
Significant Problems. weight (adjusted by
percent change in
average weight of the
cases in other MS DRGs).
795................... Normal Newborn....... Final FY 2015 relative
weight (adjusted by
percent change in
average weight of the
cases in other
MS[dash]DRGs).
------------------------------------------------------------------------
We are inviting public comments on this proposal.
4. Solicitation of Public Comments on Expanding the Bundled Payments
for Care Improvement (BPCI) Initiative
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 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 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: http://innovation.cms.gov/initiatives/bundled-payments/. 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
[[Page 24415]]
a single episode of care as an alternative approach to payment for
service delivery under traditional Medicare fee-for-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 ``no-pay'' 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
episode-initiating acute care hospital stay. The 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 ``risk-bearing'' 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 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;
[[Page 24416]]
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................ 280, 281, 282.
AICD generator or lead..................... 245, 265.
Amputation................................. 239, 240, 241, 255, 256,
257, 474, 475, 476, 616,
617, 618.
Atherosclerosis............................ 302, 303.
Back and neck except spinal fusion......... 518, 519, 520.
Coronary artery bypass graft............... 231, 232, 233, 234, 235,
236.
Cardiac arrhythmia......................... 308, 309, 310.
Cardiac defibrillator...................... 222, 223, 224, 225, 226,
227.
Cardiac valve.............................. 216, 217, 218, 219, 220,
221, 266, 267.
Cellulitis................................. 602, 603.
Cervical spinal fusion..................... 471, 472, 473.
Chest pain................................. 313.
Combined anterior posterior spinal fusion.. 453, 454, 455.
Complex noncervical spinal fusion.......... 456, 457, 458
Congestive heart failure................... 291, 292, 293.
Chronic obstructive pulmonary disease, 190, 191, 192, 202, 203.
bronchitis, asthma.
Diabetes................................... 637, 638, 639.
Double joint replacement of the lower 461, 462.
extremity.
Esophagitis, gastroenteritis, and other 391, 392.
digestive disorders.
Fractures of the femur and hip or pelvis... 533, 534, 535, 536.
Gastrointestinal hemorrhage................ 377, 378, 379.
Gastrointestinal obstruction............... 388, 389, 390.
Hip and femur procedures except major joint 480, 481, 482.
Lower extremity and humerus procedure 492, 493, 494.
except hip, foot, femur.
Major bowel procedures..................... 329, 330, 331.
Major cardiovascular procedure............. 237, 238.
Major joint replacement of the lower 469, 470.
extremity.
Major joint replacement of the upper 483.
extremity.
Medical noninfectious orthopedic........... 537, 538, 551, 552, 553,
554, 555, 556, 557, 558,
559, 560, 561, 562, 563.
Medical peripheral vascular disorders...... 299, 300, 301.
Nutritional and metabolic disorders........ 640, 641.
Other knee procedures...................... 485, 486, 487, 488, 489.
Other respiratory.......................... 189, 204, 205, 206, 207,
208, 186, 187, 188.
Other vascular surgery..................... 252, 253, 254.
Pacemaker.................................. 242, 243, 244.
Pacemaker device replacement or revision... 258, 259, 260, 261, 262.
Percutaneous coronary intervention......... 246, 247, 248, 249, 250,
251.
Red blood cell disorders................... 811, 812.
Removal of orthopedic devices.............. 495, 496, 497, 498, 499.
Renal failure.............................. 682, 683, 684.
Revision of the hip or knee................ 466, 467, 468.
Sepsis..................................... 870, 871, 872.
Simple pneumonia and respiratory infections 177, 178, 179, 193, 194,
195.
Spinal fusion (noncervical)................ 459, 460.
Stroke..................................... 61, 62, 63, 64, 65, 66.
Syncope and collapse....................... 312.
Transient ischemia......................... 69.
Urinary tract infection.................... 689, 690.
------------------------------------------------------------------------
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 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 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
[[Page 24417]]
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 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 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
[[Page 24418]]
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.
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
value-based 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 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 Sec. 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
[[Page 24419]]
regarding substantial similarity in detail.
Under the second criterion, Sec. 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page-Items/FY2015-Final-Rule-Tables.html to download and view Table 10. We note that later in
this section under the discussion of the WATCHMAN[supreg] 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, Sec. 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 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 Sec.
412.88, if the costs of the discharge (determined by applying cost-to-
charge ratios (CCRs) as described in Sec. 412.84(h)) exceed the full
DRG payment (including payments for IME and DSH, but excluding outlier
payments), Medicare will make an add-on 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 Sec. 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 Sec. 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
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
co-chaired 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 claims-payment 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 high-
quality, 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 user-
friendly format. This guide was published in 2010 and is available on
the CMS Web site at: http://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.
[[Page 24420]]
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
[email protected].
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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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 Add-On 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 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 add-on 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 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, well-
defined, 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
[[Page 24421]]
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 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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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
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: http://www.cms.gov/Medicare/Coding/ICD10/index.html 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[supreg])
BTG International, Inc. submitted an application for new technology
add-on payments for Glucarpidase (Voraxaze[supreg]) 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[supreg] was approved by the FDA on January 17, 2012.
Beginning in 1993, certain patients could obtain expanded access for
treatment use to Voraxaze[supreg] as an investigational drug. Since
2007, the applicant has been authorized to recover the costs of making
Voraxaze[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg]
and consideration of the public comments we received in response to the
FY 2013 IPPS/LTCH PPS proposed rule, we approved Voraxaze[supreg] for
new technology add-on payments for FY 2013. Cases of Voraxaze[supreg]
are identified with ICD-9-CM procedure code 00.95 (Injection or
[[Page 24422]]
infusion of glucarpidase). As stated in the FY 2015 IPPS/LTCH PPS final
rule correction notice (79 FR 59679), the cost of Voraxaze[supreg] 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[supreg] is $94,500 ($23,625 x 4). Under Sec. 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[supreg] 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'' (Sec. 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[supreg], we
considered the beginning of the newness period to commence when
Voraxaze[supreg] was first made available on the U.S. market on April
30, 2012. Because the 3-year anniversary date for Voraxaze[supreg]
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[supreg] for FY 2016. We are inviting public comments on this
proposal.
b. Zenith[supreg] Fenestrated Abdominal Aortic Aneurysm (AAA)
Endovascular Graft
Cook[supreg] Medical submitted an application for new technology
add-on payments for the Zenith[supreg] Fenestrated Abdominal Aortic
Aneurysm (AAA) Endovascular Graft (Zenith[supreg] F. Graft) for FY
2013. The applicant stated that the current treatment for patients who
have had an AAA is an endovascular graft. The applicant explained that
the Zenith[supreg] 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[supreg] 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[supreg] F. Graft was approved by the FDA
on April 4, 2012, we believed that the Zenith[supreg] 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[supreg] 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[supreg] F. Graft for new technology add-on payments
for FY 2013. Cases involving the Zenith[supreg] 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[supreg] F. Graft. The
total cost of the Zenith[supreg] F. Graft utilizing bare metal (renal)
alignment stents was $17,264. Of the $17,264 in costs for the
Zenith[supreg] 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[supreg] F. Graft. Therefore, the total maximum cost for
the Zenith[supreg] F. Graft is $16,343 ($17,264-$921). Under Sec.
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[supreg] F. Graft
is $8,171.50.
With regard to the newness criterion for the Zenith[supreg] F.
Graft, we considered the beginning of the newness period to commence
when the Zenith[supreg] F. Graft was approved by the FDA on April 4,
2012. Because the 3-year anniversary date of the entry of the
Zenith[supreg] 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 add-on 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[supreg] 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
[[Page 24423]]
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 x 5). Under Sec.
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.
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: http://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) 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 Sec. 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: http://www.cms.gov/Regulations-and-Guidance/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
[[Page 24424]]
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: http://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.
d. Argus[supreg] II Retinal Prosthesis System
Second Sight Medical Products, Inc. submitted an application for
new technology add-on payments for the Argus[supreg] II Retinal
Prosthesis System (Argus[supreg] II System) for FY 2014. The
Argus[supreg] 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[supreg] 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 approximately 4
hours and is performed under general anesthesia.
The Argus[supreg] 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[supreg]
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[supreg] 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
connected to a ``Psychophysical Test System'' to evaluate patients'
performance with the Argus[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg]
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
[[Page 24425]]
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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] II System met all of the new technology add-on payment
policy criteria. Therefore, we approved the Argus[supreg] II System for
new technology add-on payments in FY 2014 (78 FR 50580 through 50583).
Cases involving the Argus[supreg] 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[supreg] II System. The total operating cost
of the Argus[supreg] II System is $144,057.50. Under Sec.
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[supreg] II System
for FY 2014 was $72,028.75.
With regard to the newness criterion for the Argus[supreg] II
System, we considered the beginning of the newness period to commence
when the Argus[supreg] 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[supreg] 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[supreg] 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[supreg] II System would
remain at $72,028.75 for FY 2016. We are inviting public comments on
this proposal.
e. Zilver[supreg] PTX[supreg] Drug Eluting Peripheral Stent
Cook[supreg] Medical submitted an application for new technology
add-on payments for the Zilver[supreg] PTX[supreg] Drug Eluting
Peripheral Stent (Zilver[supreg] PTX[supreg]) for FY 2014. The
Zilver[supreg] PTX[supreg] 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 self-expanding, 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 risk of renarrowing of the coronary arteries after
stenting procedures.
The applicant received FDA approval on November 15, 2012, for the
Zilver[supreg] PTX[supreg]. The applicant maintains that the
Zilver[supreg] PTX[supreg] 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 add-on payment
application and consideration of the public comments received, we
approved the Zilver[supreg] PTX[supreg] for new technology add-on
payments in FY 2014. Cases involving the Zilver[supreg] PTX[supreg]
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[supreg] PTX[supreg]
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[supreg] PTX[supreg] 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[supreg] PTX[supreg] would incur an average cost per case of
$3,410.50 ($1,795 x 1.9). Under Sec. 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[supreg] PTX[supreg] was $1,705.25 for FY 2014.
With regard to the newness criterion for the Zilver[supreg]
PTX[supreg], we considered the beginning of the newness period to
commence when the Zilver[supreg] PTX[supreg] was approved by the FDA on
November 15, 2012. Because the 3-year anniversary date of the entry of
the Zilver[supreg] PTX[supreg] 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[supreg] PTX[supreg] for
FY 2016. We are inviting public comments on this proposal.
[[Page 24426]]
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, 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 add-on 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 Sec.
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, 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[supreg] System
Abbott Vascular submitted an application for new technology add-on
payments for the MitraClip[supreg] System for FY 2015. The
MitraClip[supreg] System is a transcatheter mitral valve repair system
that includes a MitraClip[supreg] 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[supreg]
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
[[Page 24427]]
expected benefit from correction of the mitral regurgitation.''
The MitraClip[supreg] System mitral valve repair procedure is based
on the double-orifice 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[supreg] System
received a premarket approval from the FDA on October 24, 2013. The
MitraClip[supreg] 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[supreg] System became immediately
available on the U.S. market following FDA approval. The
MitraClip[supreg] 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[supreg] 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: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.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[supreg] System and consideration of the public comments we
received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we
approved the MitraClip[supreg] 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[supreg] consistent with the NCD. Cases involving the
MitraClip[supreg] 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[supreg] 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[supreg] System is $15,000 for FY 2015.
With regard to the newness criterion for the MitraClip[supreg]
System, we considered the beginning of the newness period to commence
when the MitraClip[supreg] System was approved by the FDA on October
24, 2013. Because the 3-year anniversary date of the entry of the
MitraClip[supreg] 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[supreg]
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[supreg] System would remain at
$15,000 for FY 2016. We are inviting public comments on this proposal.
h. Responsive Neurostimulator (RNS[supreg]) System
NeuroPace, Inc. submitted an application for new technology add-on
payments for FY 2015 for the use of the RNS[supreg] 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. According to the
applicant, the RNS[supreg] 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[supreg] 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[supreg]
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[supreg] 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[supreg]
System and consideration of the public comments we received in response
to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the RNS[supreg]
System for new technology add-on payments for FY 2015 (79 FR 49950).
Cases involving the RNS[supreg] 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
[[Page 24428]]
generator) in combination with 02.93 (Implantation or replacement of
intracranial neurostimulator lead(s)). According to the applicant,
cases using the RNS[supreg] System would incur an anticipated cost per
case of $36,950. Under Sec. 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[supreg] System is
$18,475.
With regard to the newness criterion for the RNS[supreg] System, we
considered the beginning of the newness period to commence when the
RNS[supreg] System was approved by the FDA on November 14, 2013.
Because the 3-year anniversary date of the entry of the RNS[supreg]
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[supreg] 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[supreg]
System would remain at $18,475 for FY 2016. We are inviting public
comments on this proposal.
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 Sec. 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[supreg] Ischemic Monitoring Device
Angel Medical Systems, Inc. submitted an application for new
technology add-on payments for the Angel Medical Guardian[supreg]
Ischemic Monitoring Device (hereinafter referred to as the
Guardian[supreg]). The Guardian[supreg] implantable ischemia detection
system is designed to provide early detection 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[supreg]
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[supreg]
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 approach) is the comparable translation for ICD-9-CM
procedure code 00.57, which specifically describe procedures involving
the Guardian[supreg] technology. We note that, in accordance with Sec.
412.87(c), in order for a technology to be considered for new
technology add-on 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[supreg] technology. Therefore, the
applicant believed that the Guardian[supreg] technology is not
substantially similar to any other currently approved technology. We
are inviting public comments on whether the Guardian[supreg] technology
meets the newness criterion.
With respect to the cost criterion, the applicant determined that
cases involving the Guardian[supreg] 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[supreg] 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[supreg] 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
[[Page 24429]]
Guardian[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] technology performed by each hospital participating in
the Guardian[supreg] 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[supreg] technology, which resulted in an adjusted average
case-weighted charge per case of $89,050. Because this adjusted average
case-weighted 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 applicant
maintained that the Guardian[supreg] 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[supreg] 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[supreg] 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[supreg] technology meets the cost criterion, 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[supreg] 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[supreg] 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[supreg] technology were free from system-related
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-to-door for patients
treated using the Guardian[supreg] technology alert system turned on
(51 minutes) versus patients treated using the Guardian[supreg]
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[supreg] technology when
the alarm system was activated.
[[Page 24430]]
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[supreg] 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[supreg] 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[supreg] 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[supreg] technology. According to the
commenters, use of the Guardian[supreg] 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[supreg] 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[supreg] device as a
means of monitoring and protection. The commenters believed that the
Guardian[supreg] device provides patients and providers with an
important tool for helping to recognize when a significant 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg]
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. 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[supreg] 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[supreg] device.
b. Blinatumomab (BLINCYTOTM)
Amgen, Inc. submitted an application for new technology add-on
payments for Blinatumomab (BLINCYTOTM), a bi-specific T-cell
engager (BiTE) used for the treatment of Philadelphia chromosome-
negative (Ph-) relapsed or refractory (R/R) B-cell precursor acute-
lymphoblastic 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 T-
cell 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 T-cell 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
[[Page 24431]]
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 28-day 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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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 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 MCSP-specific
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 bi-specific 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 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 anti-cancer 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
[[Page 24432]]
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 PPS-exempt 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 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 case-weighted 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
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 case-weighted 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
[[Page 24433]]
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 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 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
[[Page 24434]]
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 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
[beta]-lactamase (ESBL)-producing Gram-negative pathogens, carbapenem-
resistant Enterobacteriaceae (CRE), and multidrug-resistant (MDR)
Pseudomonas aeruginosa.
AVYCAZ is an intravenous [beta]-lactam/[beta]-lactamase inhibitor
combination antibacterial drug, consisting of an anti-pseudomonal,
Cephalosporin (also referred to as Ceftazidime), and a [beta]-lactamase
inhibitor, Avibactam. Ceftazidime is currently available and widely
used as an extended spectrum of 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 [szlig]-lactamase enzymes, which cleave the [szlig]-lactam in
antibiotics such as penicillin that have a [szlig]-lactam ring in their
structure. The [szlig]-lactamase enzymes inactivate the antibiotic and
cause the bacteria to become resistant to that antibiotic. To avoid
development of resistance, in current practices [szlig]-lactamase
inhibitors are administered in combination with [szlig]-lactam
antibiotics to inhibit the action of [szlig]-lactamase enzymes and
prevent the development of antibiotic resistance because [szlig]-
lactamase inhibitors block the activity of [szlig]-lactamase enzymes.
This tends to widen the spectrum of antibacterial activity. For
example, a commonly used [beta]-lactamase inhibitor, Clavulanic acid or
Clavulanate, is usually combined with Amoxicillin to create Augmentin
or Ticarcillin (Timentin); Sulbactam (also a commonly used [szlig]-
lactamase inhibitor) is usually combined with Ampicillin to create
Cefoperazone; and Tazobactam is usually combined with Piperacillin.
Ceftazidime is not combined with any [beta]-lactamase inhibitors.
Combining Ceftazidime with Avibactam prohibits bacteria from developing
resistance to the antibiotic and protects Ceftazidime from being
inactivated by [beta]-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, active-controlled 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
[[Page 24435]]
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 Ceftazidime-
Avibactam Anti-infective. More information on this request can be found
on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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 ceftazidime-avibactam 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
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.
---------------------------------------------------------------------------
\6\ Drugs for urinary tract infections. JAMA. 2014;311(8):855-6.
Available at: http://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: http://cid.oxfordjournals.org/content/50/2/133.full.
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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
the spectrum of [szlig]-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 extended-spectrum [beta]-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
[[Page 24436]]
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-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 8-day
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 case-weighted standardized charge
per case that ranged from $42,469 to $46,842. 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.
---------------------------------------------------------------------------
\8\ Antibiotics. Merck Manual. Available at: http://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: http://www.amr-data.com/.
\10\ Centers for Medicare and Medicaid Services. Market Basket
Data. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketData.html.
---------------------------------------------------------------------------
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 case-
weighted 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
case-weighted 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 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-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
[[Page 24437]]
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 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.
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 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 extended-spectrum [beta]-lactamase
(ESBL)-producing Gram-negative pathogens, carbapenem-resistant
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, Gram-negative bacteria have
evolved in defense against recently approved broad-spectrum [beta]-
lactam agents (for example, [szlig]-lactam [szlig]-lactamase inhibitors
[BL-BLIs] and carbapenems) by producing a multitude of ``new'' [beta]-
lactamases--including extended-spectrum [beta]-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: http://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: http://www.cdc.gov/vitalsigns/pdf/2013-03-vitalsigns.pdf.
\13\ Antobiotics. Merck Manual. Available at: http://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.
Jacoby GA, Munoz-Price LS. The New [beta]-Lactamases.N Engl J
Med 2005; 352:380-391.
---------------------------------------------------------------------------
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, [beta]-lactamase-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 ceftazidime-nonsusceptible (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 Sec. 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.
---------------------------------------------------------------------------
\15\ Pooled data includes subset of patients from Phase II
trials and interim data from the Phase III REPRISE trial.
\16\ http://medical-dictionary.thefreedictionary.com/test+of+cure.
---------------------------------------------------------------------------
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 [beta]-lactamase (ESBL). We are concerned
that in vitro studies may not necessarily correlate with clinical
results.
---------------------------------------------------------------------------
\17\ Data on File. Actavis 2014.
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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
[[Page 24438]]
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 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[supreg] Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc. submitted an application for new
technology add-on payments for the DIAMONDBACK 360[supreg] Coronary
Orbital Atherectomy System (OAS) (DIAMONDBACK[supreg] Coronary OAS) for
FY 2016. The DIAMONDBACK[supreg] Coronary OAS is a percutaneous orbital
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[supreg] Coronary OAS are:
(1) The DIAMONBACK 360[supreg] 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[supreg] 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[supreg] OAD and
the VIPERWIRE. The Orbital Atherectomy System Pump provides the saline
pumping mechanism and power to the DIAMONBACK 360[supreg] OAD. All
DIAMONDBACK[supreg] Coronary OAS devices are single use and provide
sterile application, except for the pump.
With respect to the newness criterion, the DIAMONDBACK[supreg]
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:
http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html.
According to the applicant, the DIAMONDBACK[supreg] 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[supreg] 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
[[Page 24439]]
DIAMONDBACK[supreg] 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[supreg] 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[supreg]
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[supreg] Coronary
OAS technology would be appropriate are assigned to MS-DRG 246
(Percutaneous Cardiovascular Procedure with Drug-Eluting Stent with MCC
or 4+ Vessels/Stents); MS-DRG 247 (Percutaneous Cardiovascular
Procedure with Drug-Eluting 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[supreg] 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[supreg] 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[supreg]
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[supreg] Coronary OAS or other atherectomy devices currently
available on the U.S. market in order to determine if the
DIAMONDBACK[supreg] Coronary OAS treats a different patient population
as the applicant claimed.
We are inviting public comments on if, and how, the
DIAMONDBACK[supreg] 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.
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[supreg] 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[supreg] 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[supreg] 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[supreg] Coronary OAS device exceeds the average case-
weighted 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
[[Page 24440]]
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[supreg] 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[supreg] 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 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[supreg] 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[supreg] 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[supreg] Coronary OAS
meets the cost criterion.
The applicant maintained that the DIAMONDBACK[supreg] 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[supreg] Coronary OAS device
significantly improves clinical outcomes for this patient population
when compared to currently available treatment options, including
reduced mortality, a reduced rate of device-related 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[supreg] 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[supreg] Coronary OAS was used to prepare patients
who had severely calcified coronary lesions for stent placement.
According to the applicant, the DIAMONDBACK[supreg] 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[supreg] 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
[[Page 24441]]
helped to facilitate stent delivery, but also improved both acute care
and 30-day 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 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.
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
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 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[supreg]
Coronary OAS meets the substantial clinical improvement criterion.
e. CRESEMBA[supreg] (Isavuconazonium)
Astellas Pharma US, Inc. (Astellas) submitted an application for
new technology add-on payments for CRESEMBA[supreg] (isavuconazonium)
for FY 2016. CRESEMBA[supreg] 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[supreg] 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: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html.
[[Page 24442]]
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[supreg] meets the newness
criterion.
CRESEMBA[supreg] is part of the category of drugs known as azole
antifungal drugs that inhibit the enzyme lanosterol 14 [alpha]-
demethylase. 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 http://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[hyphen]line of therapy and
the only FDA[hyphen]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-D-glucan 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 (http://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 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[supreg] 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[supreg] 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[supreg]
is part of the category of 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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
[[Page 24443]]
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[hyphen]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 case-weighted standardized charge per
case of $151,450. Because this average case-weighted standardized
charge per case exceeded the average case-weighted threshold amount
from the FY 2015 Table 10, the applicant maintained that
CRESEMBA[supreg] 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 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
case-weighted standardized charge per case exceeded the average case-
weighted threshold amount in the FY 2015 Table 10, the applicant
maintained that CRESEMBA[supreg] 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[supreg] 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[supreg]
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[supreg] 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[supreg] 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
information regarding its SECURE study, where the primary endpoint of
all-cause mortality through day 42 showed that CRESEMBA[supreg]
demonstrated noninferiority to voriconazole. The primary endpoint of
all[hyphen]cause mortality through day 42 in the
intent[hyphen]to[hyphen]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[supreg] 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 treatment-emergent adverse
reactions occurred in 96 percent and 99 percent of patients receiving
the CRESEMBA[supreg] and voriconazole, respectively. We are concerned
that the adverse reactions associated with the use of CRESEMBA[supreg]
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[hyphen]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.
---------------------------------------------------------------------------
\25\ Lin SJ, Schranz J, Teutsch SM.: Aspergillosis
case[hyphen]fatality rate: systematic review of the literature.
ClinInfect Dis. 2001;32:358[hyphen]66.
\26\ Greenberg RN, Scott LJ, Vaughn HH, Ribes JA.: Zygomycosis
(mucormycosis): emerging clinical importance and new treatments.
Curr Opin Infect Dis. 2004;17:517[hyphen]25.
---------------------------------------------------------------------------
With regard to improved efficacy, the applicant made several
assertions. The applicant maintained that the use of CRESEMBA[supreg]
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.
---------------------------------------------------------------------------
\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[hyphen]60.
---------------------------------------------------------------------------
Specifically, the applicant believed that CRESEMBA[supreg] has
positive activity against a broad range of fungi, including those
resistant to other agents, thereby potentially decreasing subsequent
therapeutic interventions.\28\ However,
[[Page 24444]]
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[supreg] is used to treat immunocomprised patients who are
severely ill. The applicant also stated that CRESEMBA[supreg] 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[supreg] 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\
---------------------------------------------------------------------------
\28\ Gonz[aacute]lez GM.: Med Mycol. 2009 Feb;47(1):71-6.
doi:10.1080/13693780802562969. Epub 2008 Dec 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.
---------------------------------------------------------------------------
With regard to improved safety and a more favorable pharmacokinetic
profile, the applicant made several assertions. The applicant asserted
that CRESEMBA[supreg] 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[supreg] has a lower drug[hyphen]drug interaction potential
than voriconazole or itraconazole, but did not provide data to
substantiate this assertion. Furthermore, the applicant maintained that
CRESEMBA[supreg] 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[supreg] 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-to-drug interactions and
nephrotoxicity.
---------------------------------------------------------------------------
\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[hyphen]60.
---------------------------------------------------------------------------
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 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[supreg] 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[supreg] for new technology add-on 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[supreg]
(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
[[Page 24445]]
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:
http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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),
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 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
[[Page 24446]]
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 case-weighted 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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\33\ Pradaxa[supreg] (Dabigatran Etexilate Mesylate) prescribing
information. Ridgefield, CT: Boehringer Ingelheim; 2014.
---------------------------------------------------------------------------
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. The
applicant also provided data from a randomized, double-blind, placebo-
controlled 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 24447]]
clinical improvement criterion, specifically in regard to these
concerns.
g. LUTONIX[supreg] 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[supreg] Drug-Coated Balloon (DCB) Percutaneous Transluminal
Angioplasty (PTA) Catheter (LUTONIX[supreg]) 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\
---------------------------------------------------------------------------
\35\ Tepe G, Zeller T, Albrecht T, Heller S, Schwarzw[auml]lder
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: http://dx.doi.org/10.1016/j.jacc.2013.01.004.
---------------------------------------------------------------------------
The applicants for LUTONIX[supreg] 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 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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 drug-coated 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 and distal
to the target lesion and predilated segment (including overlap of
multiple balloons). The interventionalist inflates the drug-coated
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[supreg] 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)
[[Page 24448]]
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[supreg] 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 drug-coated PTA balloons used for treating
PAD. More information on this request can be found on the CMS Web site
at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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):
----------------------------------------------------------------------------------------------------------------
ICD-10-PCS code Code description
----------------------------------------------------------------------------------------------------------------
047K041..................................... Dilation of right femoral artery with drug-eluting intraluminal
device using drug-coated balloon, open approach.
047K0D1..................................... Dilation of right femoral artery with intraluminal device using
drug-coated balloon, open approach.
047K0Z1..................................... Dilation of right femoral artery using drug-coated balloon, open
approach.
047K341..................................... Dilation of right femoral artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous approach.
047K3D1..................................... Dilation of right femoral artery with intraluminal device using
drug-coated balloon, percutaneous approach.
047K3Z1..................................... Dilation of right femoral artery using drug-coated balloon,
percutaneous approach.
047K441..................................... Dilation of right femoral artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous endoscopic
approach.
047K4D1..................................... Dilation of right femoral artery with intraluminal device using
drug-coated balloon, percutaneous endoscopic approach.
047K4Z1..................................... Dilation of right femoral artery using drug-coated balloon,
percutaneous endoscopic approach.
047L041..................................... Dilation of left femoral artery with drug-eluting intraluminal
device using drug-coated balloon, open approach.
047L0D1..................................... Dilation of left femoral artery with intraluminal device using
drug-coated balloon, open approach.
047L0Z1..................................... Dilation of left femoral artery using drug-coated balloon, open
approach.
047L341..................................... Dilation of left femoral artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous approach.
047L3D1..................................... Dilation of left femoral artery with intraluminal device using
drug-coated balloon, percutaneous approach.
047L3Z1..................................... Dilation of left femoral artery using drug-coated balloon,
percutaneous approach.
047L441..................................... Dilation of left femoral artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous endoscopic
approach.
047L4D1..................................... Dilation of left femoral artery with intraluminal device using
drug-coated balloon, percutaneous endoscopic approach.
047L4Z1..................................... Dilation of left femoral artery using drug-coated balloon,
percutaneous endoscopic approach.
047M041..................................... Dilation of right popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, open approach.
047M0D1..................................... Dilation of right popliteal artery with intraluminal device using
drug-coated balloon, open approach.
047M0Z1..................................... Dilation of right popliteal artery using drug-coated balloon, open
approach.
047M341..................................... Dilation of right popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous approach.
047M3D1..................................... Dilation of right popliteal artery with intraluminal device using
drug-coated balloon, percutaneous approach.
047M3Z1..................................... Dilation of right popliteal artery using drug-coated balloon,
percutaneous approach.
047M441..................................... Dilation of right popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous endoscopic
approach.
047M4D1..................................... Dilation of right popliteal artery with intraluminal device using
drug-coated balloon, percutaneous endoscopic approach.
047M4Z1..................................... Dilation of right popliteal artery using drug-coated balloon,
percutaneous endoscopic approach.
047N041..................................... Dilation of left popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, open approach.
047N0D1..................................... Dilation of left popliteal artery with intraluminal device using
drug-coated balloon, open approach.
047N0Z1..................................... Dilation of left popliteal artery using drug-coated balloon, open
approach.
047N341..................................... Dilation of left popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous approach.
047N3D1..................................... Dilation of left popliteal artery with intraluminal device using
drug-coated balloon, percutaneous approach.
047N3Z1..................................... Dilation of left popliteal artery using drug-coated balloon,
percutaneous approach.
047N441..................................... Dilation of left popliteal artery with drug-eluting intraluminal
device using drug-coated balloon, percutaneous endoscopic
approach.
047N4D1..................................... Dilation of left popliteal artery with intraluminal device using
drug-coated balloon, percutaneous endoscopic approach.
047N4Z1..................................... 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 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 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
[[Page 24449]]
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[supreg], 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 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 case-weighted 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 case-weighted 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 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 case-weighted standardized charge amounts exceed
the corresponding average case-weighted threshold amounts of $69,594,
$74,449, and $75,215, respectively, using the FY 2015 IPPS Table 10,
the applicant maintained that the LUTONIX[supreg] 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
[[Page 24450]]
(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 case-weighted standardized 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 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[supreg] and
IN.PACTTM AdmiralTM meet the cost criterion.
With regard to substantial clinical improvement, the applicant
believed that LUTONIX[supreg] represents a substantial clinical
improvement because it meets an unmet clinical need by providing access
to ``no stent zones'' and because it can achieve greater patency;
preserve the flexibility of future interventions; and address stent
fractures and re-stenosis.39 40
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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[supreg] 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[supreg] drug-coated balloon treatment group
(0.461.13) compared to the control PTA group (1.091.07), 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[supreg] 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[supreg] was 65.2 percent
compared to primary patency of 52.6 percent for PTA. Kaplan-Meier
analysis was 73.5 percent for LUTONIX[supreg] 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[supreg] 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[supreg] 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[supreg] 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 proof-of-concept research has
demonstrated the utility of various drug-coated balloon technologies in
reducing restenosis and reintervention compared
[[Page 24451]]
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 procedure-related
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 non-stented restenotic
lesions in the SFA and/or popliteal artery (PPA) were randomized in a
2:1 fashion to treatment with IN.PACTTM Admiral
TM drug-coated 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 (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 drug-
coated balloon and control technology.
---------------------------------------------------------------------------
\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,
H[auml]nninen 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, Schwarzw[auml]lder
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.
---------------------------------------------------------------------------
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 Ankle-
Brachial 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 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).
---------------------------------------------------------------------------
\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.
\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.
---------------------------------------------------------------------------
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 6-minute 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.
---------------------------------------------------------------------------
\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:
http://www.effectivehealthcare.ahrq.gov/reports/final.
_____________________________________-
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
[[Page 24452]]
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 ankle-brachial 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[supreg] 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[supreg] 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 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[supreg] and the IN.PACTTM AdmiralTM
technologies, with hopes of minimizing any financial barriers that
might prevent patients from having access to this technology.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Another commenter supported the approval of new technology add-on
payments for the LUTONIX[supreg] 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 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 intra-articular 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.
[[Page 24453]]
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, 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
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:
http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-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
[[Page 24454]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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. 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
case-weighted charges per case for cases assigned to MS-DRGs 461 and
462 was slightly higher than the charges removed from cases assigned to
MS-
[[Page 24455]]
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 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, 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 case-
weighted 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 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 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 case-weighted 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 case-
weighted standardized charge per case of $90,515. Using the FY 2015
IPPS Table 10 thresholds, the applicant determined that the average
case-
[[Page 24456]]
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 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 case-weighted
charge per case for cases assigned to MS-DRGs 466-470 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 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 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 case-
weighted standardized charge per case of $66,382. Using the FY 2015
IPPS Table 10 thresholds, the applicant determined that the average
case-weighted 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
[[Page 24457]]
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\
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\48\ Rodriguez-Merchan EC.: Instability Following Total Knee
Arthroplasty. HSSJ 2011; 7:273-278.
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Dynamic intercompartmental load data and Kinetic Tracking
enables evidence based soft tissue releases to improve stability
through full ROM;\49\
---------------------------------------------------------------------------
\49\ Roche MW, Elson LC, Anderson CR.: A Novel Technique Using
Sensor-Based Technology to Evaluate Tibial Tray Rotation.
Orthopedics. 2014 (In Press).
---------------------------------------------------------------------------
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 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\
---------------------------------------------------------------------------
\50\ Gustke KA, et al.: Increased satisfaction after total knee
replacement using sensor-guided technology. Bone Joint J 2014;96-
B:1333-8.
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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.
---------------------------------------------------------------------------
\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)
---------------------------------------------------------------------------
The applicant further stated that the VKS technology provides
intraoperative information on tibial-femoral component rotation,
position of femoral 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[deg], ranging from 0.5[deg] 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.
---------------------------------------------------------------------------
\52\ Roche MW, Elson LC, Anderson CR: A Novel Technique Using
Sensor-Based Technology to Evaluate Tibial Tray Rotation.
Orthopedics. 2015 (In Press)
---------------------------------------------------------------------------
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
[[Page 24458]]
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 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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 sensor-guided 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