[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 41144-41784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16766]
[[Page 41143]]
Vol. 83
Friday,
No. 160
August 17, 2018
Part II
Book 2 of 3 Books
Pages 41143-41784
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 413, 424, et al.
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long Term Care Hospital Prospective
Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality
Reporting Requirements for Specific Providers; Medicare and Medicaid
Electronic Health Record (EHR) Incentive Programs (Promoting
Interoperability Programs) Requirements for Eligible Hospitals,
Critical Access Hospitals, and Eligible Professionals; Medicare Cost
Reporting Requirements; and Physician Certification and Recertification
of Claims; Final Rule
Federal Register / Vol. 83 , No. 160 / Friday, August 17, 2018 /
Rules and Regulations
[[Page 41144]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, 424, and 495
[CMS-1694-F]
RIN 0938-AT27
Medicare Program; Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality
Reporting Requirements for Specific Providers; Medicare and Medicaid
Electronic Health Record (EHR) Incentive Programs (Promoting
Interoperability Programs) Requirements for Eligible Hospitals,
Critical Access Hospitals, and Eligible Professionals; Medicare Cost
Reporting Requirements; and Physician Certification and Recertification
of Claims
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: We are revising 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 2019. Some of these changes
implement certain statutory provisions contained in the 21st Century
Cures Act and the Bipartisan Budget Act of 2018, and other legislation.
We also are making changes relating to Medicare graduate medical
education (GME) affiliation agreements for new urban teaching
hospitals. In addition, we are providing the market basket update that
will apply to 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 2019. We are updating 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 2019.
In addition, we are establishing new requirements or revising
existing requirements for quality reporting by specific Medicare
providers (acute care hospitals, PPS-exempt cancer hospitals, and
LTCHs). We also are establishing new requirements or revising existing
requirements for eligible professionals (EPs), eligible hospitals, and
critical access hospitals (CAHs) participating in the Medicare and
Medicaid Electronic Health Record (EHR) Incentive Programs (now
referred to as the Promoting Interoperability Programs). In addition,
we are finalizing modifications to the requirements that apply to
States operating Medicaid Promoting Interoperability Programs. We are
updating policies for the Hospital Value-Based Purchasing (VBP)
Program, the Hospital Readmissions Reduction Program, and the Hospital-
Acquired Condition (HAC) Reduction Program.
We also are making changes relating to the required supporting
documentation for an acceptable Medicare cost report submission and the
supporting information for physician certification and recertification
of claims.
DATES: This final rule is effective on October 1, 2018.
FOR FURTHER INFORMATION CONTACT: Donald Thompson, (410) 786-4487, and
Michele Hudson, (410) 786-4487, Operating Prospective Payment, MS-DRGs,
Wage Index, New Medical Service and Technology Add-On Payments,
Hospital Geographic Reclassifications, Graduate Medical Education,
Capital Prospective Payment, Excluded Hospitals, Sole Community
Hospitals, Medicare Disproportionate Share Hospital (DSH) Payment
Adjustment, Medicare-Dependent Small Rural Hospital (MDH) Program, and
Low-Volume Hospital Payment Adjustment Issues.
Michele Hudson, (410) 786-4487, Mark Luxton, (410) 786-4530, and
Emily Lipkin, (410) 786-3633, 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.
Jeris Smith, (410) 786-0110, Frontier Community Health Integration
Project Demonstration Issues.
Cindy Tourison, (410) 786-1093, Hospital Readmissions Reduction
Program--Readmission Measures for Hospitals Issues.
James Poyer, (410) 786-2261, Hospital Readmissions Reduction
Program--Administration Issues.
Elizabeth Bainger, (410) 786-0529, Hospital-Acquired Condition
Reduction Program Issues.
Joseph Clift, (410) 786-4165, Hospital-Acquired Condition Reduction
Program--Measures Issues.
Grace Snyder, (410) 786-0700 and James Poyer, (410) 786-2261,
Hospital Inpatient Quality Reporting and Hospital Value-Based
Purchasing--Program Administration, Validation, and Reconsideration
Issues.
Reena Duseja, (410) 786-1999 and Cindy Tourison, (410) 786-1093,
Hospital Inpatient Quality Reporting--Measures Issues Except Hospital
Consumer Assessment of Healthcare Providers and Systems Issues; and
Readmission Measures for Hospitals Issues.
Kim Spalding Bush, (410) 786-3232, Hospital Value-Based Purchasing
Efficiency Measures Issues.
Elizabeth Goldstein, (410) 786-6665, Hospital Inpatient Quality
Reporting and Hospital Value-Based Purchasing--Hospital Consumer
Assessment of Healthcare Providers and Systems Measures Issues.
Joel Andress, (410) 786-5237 and Caitlin Cromer, (410) 786-3106,
PPS-Exempt Cancer Hospital Quality Reporting Issues.
Mary Pratt, (410) 786-6867, Long-Term Care Hospital Quality Data
Reporting Issues.
Elizabeth Holland, (410) 786-1309, Promoting Interoperability
Programs Clinical Quality Measure Related Issues.
Kathleen Johnson, (410) 786-3295 and Steven Johnson (410) 786-3332,
Promoting Interoperability Programs Nonclinical Quality Measure Related
Issues.
Kellie Shannon, (410) 786-0416, Acceptable Medicare Cost Report
Submissions Issues.
Thomas Kessler, (410) 786-1991, Physician Certification and
Recertification of Claims.
SUPPLEMENTARY INFORMATION:
Electronic Access
This Federal Register document is available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Printing Office. This database can be
accessed via the internet at: http://www.gpo.gov/fdsys.
Tables Available Through the Internet on the CMS Website
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, the majority of the
IPPS tables and LTCH PPS tables are no longer published in the Federal
Register. Instead, these tables, generally, will be available only
through the internet. The IPPS tables for this final rule are available
through the internet on the CMS website at: http://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-Service-Payment/
[[Page 41145]]
AcuteInpatientPPS/index.html. Click on the link on the left side of the
screen titled, ``FY 2019 IPPS Final Rule Home Page'' or ``Acute
Inpatient--Files for Download.'' The LTCH PPS tables for this FY 2019
final rule are available through the internet on the CMS website at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html under the list item for Regulation
Number CMS-1694-F. For further details on the contents of the tables
referenced in this final rule, we refer readers to section VI. of the
Addendum to this final rule.
Readers who experience any problems accessing any of the tables
that are posted on the CMS websites identified above should contact
Michael Treitel at (410) 786-4552.
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background Summary
C. Summary of Provisions of Recent Legislation Implemented in
this Final Rule
D. Issuance of Notice of Proposed Rulemaking
II. 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. FY 2019 MS-DRG Documentation and Coding Adjustment
E. Refinement of the MS-DRG Relative Weight Calculation
F. Changes to Specific MS-DRG Classifications
G. Recalibration of the FY 2019 MS-DRG Relative Weights
H. Add-On Payments for New Services and Technologies for FY 2019
III. Changes to the Hospital Wage Index for Acute Care Hospitals
A. Background
B. Worksheet S-3 Wage Data for the FY 2019 Wage Index
C. Verification of Worksheet S-3 Wage Data
D. Method for Computing the FY 2019 Unadjusted Wage Index
E. Occupational Mix Adjustment to the FY 2019 Wage Index
F. Analysis and Implementation of the Occupational Mix
Adjustment and the FY 2019 Occupational Mix Adjusted Wage Index
G. Application of the Rural, Imputed, and Frontier Floors
H. FY 2019 Wage Index Tables
I. Revisions to the Wage Index Based on Hospital Redesignations
and Reclassifications
J. Out-Migration Adjustment Based on Commuting Patterns of
Hospital Employees
K. Reclassification From Urban to Rural under Section
1886(d)(8)(E) of the Act Implemented at 42 CFR 412.103
L. Process for Requests for Wage Index Data Corrections
M. Labor-Related Share for the FY 2019 Wage Index
IV. Other Decisions and Changes to the IPPS for Operating System
A. Changes to MS-DRGs Subject to Postacute Care Transfer and MS-
DRG Special Payment Policies
B. Changes in the Inpatient Hospital Updates for FY 2019 (Sec.
412.64(d))
C. Rural Referral Centers (RRCs) Annual Updates to Case-Mix
Index and Discharge Criteria (Sec. 412.96)
D. Payment Adjustment for Low-Volume Hospitals (Sec. 412.101)
E. Indirect Medical Education (IME) Payment Adjustment (Sec.
412.105)
F. Payment Adjustment for Medicare Disproportionate Share
Hospitals (DSHs) for FY 2019 (Sec. 412.106)
G. Sole Community Hospitals (SCHs) and Medicare-Dependent, Small
Rural Hospitals (MDHs) (Sec. Sec. 412.90, 412.92, and 412.108)
H. Hospital Readmissions Reduction Program: Updates and Changes
(Sec. Sec. 412.150 Through 412.154)
I. Hospital Value-Based Purchasing (VBP) Program: Policy Changes
J. Changes to the Hospital-Acquired Condition (HAC) Reduction
Program
K. Payments for Indirect and Direct Graduate Medical Education
Costs (Sec. Sec. 412.105 and 413.75 Through 413.83)
L. Rural Community Hospital Demonstration Program
M. Revision of Hospital Inpatient Admission Orders Documentation
Requirements Under Medicare Part A
V. Changes to the IPPS for Capital-Related Costs
A. Overview
B. Additional Provisions
C. Annual Update for FY 2019
VI. Changes for Hospitals Excluded From the IPPS
A. Rate-of-Increase in Payments to Excluded Hospitals for FY
2019
B. Revisions to Regulations Governing Satellite Facilities
C. Revisions to Regulations Governing Excluded Units of
Hospitals
D. Report on Adjustment (Exceptions) Payments
E. Critical Access Hospitals (CAHs)
VII. Changes to the Long-Term Care Hospital Prospective Payment
System (LTCH PPS) for FY 2019
A. Background of the LTCH PPS
B. Medicare Severity Long-Term Care Diagnosis-Related Group (MS-
LTC-DRG) Classifications and Relative Weights for FY 2019
C. Modifications to the Application of the Site Neutral Payment
Rate (Sec. 412.522)
D. Changes to the LTCH PPS Payment Rates and Other Proposed
Changes to the LTCH PPS for FY 2019
E. Elimination of the ``25-Percent Threshold Policy'' Adjustment
(Sec. 412.538)
VIII. Quality Data Reporting Requirements for Specific Providers and
Suppliers
A. Hospital Inpatient Quality Reporting (IQR) Program
B. PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program
C. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)
D. Changes to the Medicare and Medicaid EHR Incentive Programs
(Now Referred to as the Medicare and Medicaid Promoting
Interoperability Programs)
IX. Revisions of the Supporting Documentation Required for
Submission of an Acceptable Medicare Cost Report
X. Requirements for Hospitals To Make Public a List of Their
Standard Charges via the Internet
XI. Revisions Regarding Physician Certification and Recertification
of Claims
XII. Request for Information on Promoting Interoperability and
Electronic Healthcare Information Exchange through Possible
Revisions to the CMS Patient Health and Safety Requirements for
Hospitals and Other Medicare- and Medicaid-Participating Providers
and Suppliers
XIII. MedPAC Recommendations
XIV. Other Required Information
A. Publicly Available Data
B. Collection of Information Requirements
C. Response to Public Comments
Regulation Text
Addendum--Schedule of Standardized Amounts, Update Factors, Rate-of-
Increase Percentages Effective With Cost Reporting Periods Beginning
on or After October 1, 2018 and Payment Rates for LTCHs Effective
for Discharges Occurring on or After October 1, 2018
I. Summary and Background
II. Changes to the Prospective Payment Rates for Hospital Inpatient
Operating Costs for Acute Care Hospitals for FY 2019
A. Calculation of the Adjusted Standardized Amount
B. Adjustments for Area Wage Levels and Cost-of-Living
C. Calculation of the Prospective Payment Rates
III. Changes to Payment Rates for Acute Care Hospital Inpatient
Capital-Related Costs for FY 2019
A. Determination of Federal Hospital Inpatient Capital-Related
Prospective Payment Rate Update
B. Calculation of the Inpatient Capital-Related Prospective
Payments for FY 2019
C. Capital Input Price Index
IV. Changes to Payment Rates for Excluded Hospitals: Rate-of-
Increase Percentages for FY 2019
V. Changes to the Payment Rates for the LTCH PPS for FY 2019
A. LTCH PPS Standard Federal Payment Rate for FY 2019
B. Adjustment for Area Wage Levels Under the LTCH PPS for FY
2019
C. LTCH PPS Cost-of-Living Adjustment (COLA) for LTCHs Located
in Alaska and Hawaii
D. Adjustment for LTCH PPS High-Cost Outlier (HCO) Cases
E. Update to the IPPS Comparable/Equivalent Amounts To Reflect
the Statutory Changes to the IPPS DSH Payment Adjustment Methodology
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F. Computing the Adjusted LTCH PPS Federal Prospective Payments
for FY 2019
VI. Tables Referenced in This Rule Generally Available Through the
Internet on the CMS Website
Appendix A--Economic Analyses
I. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Objectives of the IPPS and the LTCH PPS
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 Policy Changes Under the IPPS for
Operating Costs
H. Effects of Other Policy Changes
I. Effects of Changes in the Capital IPPS
J. Effects of Payment Rate Changes and Policy Changes Under the
LTCH PPS
K. Effects of Requirements for Hospital Inpatient Quality
Reporting (IQR) Program
L. Effects of Requirements for the PPS-Exempt Cancer Hospital
Quality Reporting (PCHQR) Program
M. Effects of Requirements for the Long-Term Care Hospital
Quality Reporting Program (LTCH QRP)
N. Effects of Requirements Regarding the Medicare and Medicaid
Promoting Interoperability Programs
O. Alternatives Considered
P. Reducing Regulation and Controlling Regulatory Costs
Q. Overall Conclusion
R. Regulatory Review Costs
II. Accounting Statements and Tables
A. Acute Care Hospitals
B. LTCHs
III. Regulatory Flexibility Act (RFA) Analysis
IV. Impact on Small Rural Hospitals
V. Unfunded Mandate Reform Act (UMRA) Analysis
VI. Executive Order 13175
VII. Executive Order 12866
Appendix B: Recommendation of Update Factors for Operating Cost
Rates of Payment for Inpatient Hospital Services
I. Background
II. Inpatient Hospital Update for FY 2019
A. FY 2019 Inpatient Hospital Update
B. Update for SCHs and MDHs for FY 2019
C. FY 2019 Puerto Rico Hospital Update
D. Update for Hospitals Excluded From the IPPS
E. Update for LTCHs for FY 2019
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 final rule makes 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 makes
payment and policy changes for inpatient hospital services provided by
long-term care hospitals (LTCHs) under the long-term care hospital
prospective payment system (LTCH PPS). This final rule also makes
policy changes to programs associated with Medicare IPPS hospitals,
IPPS-excluded hospitals, and LTCHs.
We are establishing new requirements and revising existing
requirements for quality reporting by specific providers (acute care
hospitals, PPS-exempt cancer hospitals, and LTCHs) that are
participating in Medicare. We also are establishing new requirements
and revising existing requirements for eligible professionals (EPs),
eligible hospitals, and CAHs participating in the Medicare and Medicaid
Promoting Interoperability Programs. We are updating policies for the
Hospital Value-Based Purchasing (VBP) Program, the Hospital
Readmissions Reduction Program, and the Hospital-Acquired Condition
(HAC) Reduction Program.
We are making changes relating to the supporting documentation
required for an acceptable Medicare cost report submission and the
supporting information for physician certification and recertification
of claims.
Under various statutory authorities, we are making changes to the
Medicare IPPS, to the LTCH PPS, and to other related payment
methodologies and programs for FY 2019 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; extended neoplastic disease care hospitals, and hospitals
located outside the 50 States, the District of Columbia, and Puerto
Rico (that is, hospitals located in the U.S. 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 the BBRA (Pub. L. 106-113) and
section 307(b)(1) of the BIPA (Pub. L. 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 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(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.
Section 1886(b)(3)(B)(viii) of the Act, which requires the
Secretary to reduce the applicable percentage increase that would
otherwise apply to the standardized amount applicable to a subsection
(d) hospital for discharges occurring in 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 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 and section 15002 of the 21st Century Cures Act, which
establishes the ``Hospital
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Readmissions Reduction Program.'' Under the program, payments for
discharges from an ``applicable hospital'' under section 1886(d) of the
Act will be reduced to account for certain excess readmissions. Section
15002 of the 21st Century Cures Act requires the Secretary to compare
cohorts of hospitals to each other in determining the extent of 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 (DSH) 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 requires
that, for fiscal year 2014 and each subsequent fiscal year, subsection
(d) hospitals that would otherwise receive a DSH 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 who are
uninsured (minus 0.2 percentage point for FY 2018 and FY 2019); 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 Sustainable Growth Rate (SGR) Reform Act
of 2013 (Pub. L. 113-67) and amended by section 51005(a) of the
Bipartisan Budget Act of 2018 (Pub. L. 115-123), which provided for the
establishment of site neutral payment rate criteria under the LTCH PPS,
with implementation beginning in FY 2016, and provides for a 4-year
transitional blended payment rate for discharges occurring in LTCH cost
reporting periods beginning in FYs 2016 through 2019. Section 51005(b)
of the Bipartisan Budget Act of 2018 amended section 1886(m)(6)(B) by
adding new clause (iv), which specifies that the IPPS comparable amount
defined in clause (ii)(I) shall be reduced by 4.6 percent for FYs 2018
through 2026.
Section 1886(m)(6) of the Act, as amended by section 15009
of the 21st Century Cures Act (Pub. L. 114-255), which provides for a
temporary exception to the application of the site neutral payment rate
under the LTCH PPS for certain spinal cord specialty hospitals for
discharges in cost reporting periods beginning during FYs 2018 and
2019.
Section 1886(m)(6) of the Act, as amended by section 15010
of the 21st Century Cures Act (Pub. L. 114-255), which provides for a
temporary exception to the application of the site neutral payment rate
under the LTCH PPS for certain LTCHs with certain discharges with
severe wounds occurring in cost reporting periods beginning during FY
2018.
Section 1886(m)(5)(D)(iv) of the Act, as added by section
1206(c) of the Pathway for Sustainable Growth Rate (SGR) Reform Act of
2013 (Pub. L. 113-67), which provides for the establishment of a
functional status quality measure in the LTCH QRP for change in
mobility among inpatients requiring ventilator support.
Section 1899B of the Act, as added by section 2(a) of the
Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT
Act, Pub. L. 113-185), which provides for the establishment of
standardized data reporting for certain post-acute care providers,
including LTCHs.
2. Improving Patient Outcomes and Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing regulatory burden are high
priorities for CMS. To reduce the regulatory burden on the healthcare
industry, lower health care costs, and enhance patient care, in October
2017, we launched the Meaningful Measures Initiative.\1\ This
initiative is one component of our agency-wide Patients Over Paperwork
Initiative,\2\ which is aimed at evaluating and streamlining
regulations with a goal to reduce unnecessary cost and burden, increase
efficiencies, and improve beneficiary experience. The Meaningful
Measures Initiative is aimed at identifying the highest priority areas
for quality measurement and quality improvement, in order to assess the
core quality of care issues that are most vital to advancing our work
to improve patient outcomes. The Meaningful Measures Initiative
represents a new approach to quality measures that will foster
operational efficiencies and will reduce costs, including collection
and reporting burden while producing quality measurement that is more
focused on meaningful outcomes.
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\1\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\2\ Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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The Meaningful Measures framework has the following objectives:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures, where
possible, such as electronic clinical quality measures; \3\
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\3\ We refer readers to section VIII.A.9.c. of the preamble of
this final rule where we discuss public comments on the potential
future development and adoption of eCQMs.
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Significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
In order to achieve these objectives, we have identified 19
Meaningful Measures areas and mapped them to six overarching quality
priorities, as shown in the following table:
------------------------------------------------------------------------
Quality priority Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm Healthcare-Associated
Caused in the Delivery of Care. Infections.
Preventable Healthcare Harm.
Strengthen Person and Family Engagement Care is Personalized and
as Partners in Their Care. Aligned with Patient's Goals.
End of Life Care According to
Preferences.
Patient's Experience of Care.
Patient Reported Functional
Outcomes.
[[Page 41148]]
Promote Effective Communication and Medication Management.
Coordination of Care. Admissions and Readmissions to
Hospitals.
Transfer of Health Information
and Interoperability.
Promote Effective Prevention and Preventive Care.
Treatment of Chronic Disease. Management of Chronic
Conditions.
Prevention, Treatment, and
Management of Mental Health.
Prevention and Treatment of
Opioid and Substance Use
Disorders.
Risk Adjusted Mortality.
Work with Communities to Promote Best Equity of Care.
Practices of Healthy Living. Community Engagement.
Make Care Affordable................... Appropriate Use of Healthcare.
Patient-focused Episode of
Care.
Risk Adjusted Total Cost of
Care.
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By including Meaningful Measures in our programs, we believe that
we can also address the following cross-cutting measure criteria:
Eliminating disparities;
Tracking measurable outcomes and impact;
Safeguarding public health;
Achieving cost savings;
Improving access for rural communities; and
Reducing burden.
We believe that the Meaningful Measures Initiative will improve
outcomes for patients, their families, and health care providers, while
reducing burden and costs for clinicians and providers, as well as
promoting operational efficiencies.
We received numerous comments from stakeholders regarding the
Meaningful Measures Initiative and the impact of its implementation in
CMS' quality programs. Many of these comments pertained to specific
program proposals, and are discussed in the appropriate program-
specific sections of this final rule. However, commenters also provided
insights and recommendations for the ongoing development of the
Meaningful Measures Initiative generally, including: ensuring
transparency in public reporting and usability of publicly reported
data; evaluating the benefit of individual measures to patients via use
in quality programs weighed against the burden to providers of
collecting and reporting that measure data; and identifying additional
opportunities for alignment across CMS quality programs. We look
forward to continuing to work with stakeholders to refine and further
implement the Meaningful Measures Initiative, and will take commenters'
insights and recommendations into account moving forward.
3. Summary of the Major Provisions
Below we provide a summary of the major provisions in this final
rule. In general, these major provisions are as part of the annual
update to the payment policies and payment rates, consistent with the
applicable statutory provisions. A general summary of the proposed
changes that we included in the proposed rule issued prior to this
final rule is presented in section I.D. of the preamble of this final
rule.
a. MS-DRG Documentation and Coding Adjustment
Section 631 of the American Taxpayer Relief Act of 2012 (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. The FY 2014 through FY 2017 adjustments
represented 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. Section 414 of the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114-10) replaced the single positive adjustment
we intended to make in FY 2018 with a 0.5 percent positive adjustment
to the standardized amount of Medicare payments to acute care hospitals
for FYs 2018 through 2023. (The FY 2018 adjustment was subsequently
adjusted to 0.4588 percent by section 15005 of the 21st Century Cures
Act.) Therefore, for FY 2019, we are making an adjustment of +0.5
percent to the standardized amount.
b. Expansion of the Postacute Care Transfer Policy
Section 53109 of the Bipartisan Budget Act of 2018 amended section
1886(d)(5)(J)(ii) of the Act to also include discharges to hospice care
by a hospice program as a qualified discharge, effective for discharges
occurring on or after October 1, 2018. Accordingly, we are making
conforming amendments to Sec. 412.4(c) of the regulation, effective
for discharges on or after October 1, 2018, to specify that if a
discharge is assigned to one of the MS-DRGs subject to the postacute
care transfer policy and the individual is transferred to hospice care
by a hospice program, the discharge is subject to payment as a transfer
case.
c. 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 receive 25
percent of the amount they previously would have received under the
statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of
the Act. The remaining amount, equal to 75 percent of the amount that
otherwise would have been paid as Medicare DSH payments, is paid as
additional payments after the amount is reduced for changes in the
percentage of individuals that are uninsured. Each Medicare DSH will
receive an additional payment based on its share of the total amount of
uncompensated care for all Medicare DSHs for a given time period.
In this FY 2019 IPPS/LTCH PPS final rule, we are updating our
estimates of the three factors used to determine uncompensated care
payments for FY 2019. We are continuing to use uninsured estimates
produced by CMS' Office of the Actuary (OACT) as part of the
development of the National Health Expenditure Accounts (NHEA) in the
calculation of Factor 2. We also are continuing to incorporate data
from Worksheet S-10 in the calculation of hospitals' share of the
aggregate amount
[[Page 41149]]
of uncompensated care by combining data on uncompensated care costs
from Worksheet S-10 for FYs 2014 and 2015 with proxy data regarding a
hospital's share of low-income insured days for FY 2013 to determine
Factor 3 for FY 2019. In addition, we are using only data regarding
low-income insured days for FY 2013 to determine the amount of
uncompensated care payments for Puerto Rico hospitals, Indian Health
Service and Tribal hospitals, and all-inclusive rate providers. For
this final rule, we are establishing the following policies: (1) For
providers with multiple cost reports, beginning in the same fiscal
year, to use the longest cost report and annualize Medicaid data and
uncompensated care data if a hospital's cost report does not equal 12
months of data; (2) in the rare case where a provider has multiple cost
reports, beginning in the same fiscal year, but one report also spans
the entirety of the following fiscal year, such that the hospital has
no cost report for that fiscal year, the cost report that spans both
fiscal years will be used for the latter fiscal year; and (3) to apply
statistical trim methodologies to potentially aberrant cost-to-charge
ratios (CCRs) and potentially aberrant uncompensated care costs
reported on the Worksheet S-10.
d. Changes to the LTCH PPS
In this final rule, we set forth changes to the LTCH PPS Federal
payment rates, factors, and other payment rate policies under the LTCH
PPS for FY 2019. In addition, we are eliminating the 25-percent
threshold policy, and under this policy, we are applying a one-time
adjustment of approximately 0.9 percent to the LTCH PPS standard
Federal payment rate in FY 2019 to ensure this elimination of the 25-
percent threshold policy is budget neutral.
e. Reduction of Hospital Payments for Excess Readmissions
We are making changes to policies for the Hospital Readmissions
Reduction Program, which was established under section 1886(q) of the
Act, as added by section 3025 of the Affordable Care Act, as amended by
section 10309 of the Affordable Care Act and further amended by section
15002 of the 21st Century Cures 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 FY 2018 and subsequent years, the reduction is based on
a hospital's risk-adjusted readmission rate during a 3-year period for
acute myocardial infarction (AMI), heart failure (HF), pneumonia,
chronic obstructive pulmonary disease (COPD), total hip arthroplasty/
total knee arthroplasty (THA/TKA), and coronary artery bypass graft
(CABG). In this final rule, we are establishing the applicable periods
for FY 2019, FY 2020, and FY 2021. We also are codifying the
definitions of dual-eligible patients, the proportion of dual-
eligibles, and the applicable period for dual-eligibility.
f. 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. As
part of agency-wide efforts under the Meaningful Measures Initiative to
use a parsimonious set of the most meaningful measures for patients,
clinicians, and providers in our quality programs and the Patients Over
Paperwork Initiative to reduce costs and burden and program complexity,
as discussed in section I.A.2. of the preamble of this final rule, we
are removing a total of 4 measures from the Hospital VBP Program, all
of which will continue to be used in the Hospital IQR Program, in order
to reduce the costs and complexity of tracking these measures in
multiple programs. Specifically, we are removing one measure, beginning
with the FY 2021 program year: (1) Elective Delivery (NQF #0469) (PC-
01). We also are removing three measures from the Hospital VBP Program,
effective with the effective date of this FY 2019 IPPS/LTCH PPS final
rule: (1) Hospital-Level, Risk-Standardized Payment Associated With a
30-Day Episode-of-Care for Acute Myocardial Infarction (NQF #2431) (AMI
Payment); (2) Hospital-Level, Risk-Standardized Payment Associated With
a 30-Day Episode-of-Care for Heart Failure (NQF #2436) (HF Payment);
and (3) Hospital-Level, Risk-Standardized Payment Associated With a 30-
Day Episode-of-Care for Pneumonia (PN Payment) (NQF #2579). In
addition, we are renaming the Clinical Care domain as the Clinical
Outcomes domain, beginning with the FY 2020 program year. We also are
adopting measure removal factors for the Hospital VBP Program.
We are not finalizing our proposals to remove of the following six
patient safety measures: (1) National Healthcare Safety Network (NHSN)
Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure
(NQF #0138); (2) National Healthcare Safety Network (NHSN) Central
Line-Associated Bloodstream Infection (CLABSI) Outcome Measure (NQF
#0139); (3) American College of Surgeons-Centers for Disease Control
and Prevention (ACS-CDC) Harmonized Procedure Specific Surgical Site
Infection (SSI) Outcome Measure (NQF #0753); (4) National Healthcare
Safety Network (NHSN) Facility-wide Inpatient Hospital-onset
Methicillin-resistant Staphylococcus aureus Bacteremia (MRSA) Outcome
Measure (NQF #1716); (5) National Healthcare Safety Network (NHSN)
Facility-wide Inpatient Hospital-onset Clostridium difficile Infection
(CDI) Outcome Measure (NQF #1717); and (6) Patient Safety and Adverse
Events (Composite) (NQF #0531) (PSI 90). We are not finalizing our
proposal to remove the Safety domain from the Hospital VBP Program, as
we are not finalizing our proposals to remove all of the measures in
this domain, and therefore we also are not finalizing changes to the
domain weighting.
g. 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. This 1-percent
payment reduction applies to a hospital whose ranking in the worst-
performing 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. As part of our agency-wide Patients over Paperwork and Meaningful
Measures Initiatives, discussed in section I.A.2. of the preamble of
this final rule, we are retaining the measures currently included in
the HAC Reduction Program because the measures address a performance
gap in patient safety and reduce harm caused in the delivery of care.
In this final rule, we are: (1) Establishing administrative policies to
collect, validate, and publicly report NHSN healthcare-associated
infection (HAI) quality measure data that facilitate a seamless
transition, independent of the Hospital IQR Program, beginning with
January 1, 2020 infectious events; (2) changing the scoring methodology
by removing domains and assigning equal weighting to each measure for
which a hospital has a measure; and (3) establishing the
[[Page 41150]]
applicable period for FY 2021. In addition, we are summarizing comments
we received regarding the potential future inclusion of additional
measures, including eCQMs.
h. Hospital Inpatient Quality Reporting (IQR) Program
Under section 1886(b)(3)(B)(viii) of the Act, subsection (d)
hospitals are required to report data on measures selected by the
Secretary for a fiscal year in order to receive the full annual
percentage increase that would otherwise apply to the standardized
amount applicable to discharges occurring in that fiscal year.
In this final rule, we are making several changes. As part of
agency-wide efforts under the Meaningful Measures Initiative to use a
parsimonious set of the most meaningful measures for patients and
clinicians in our quality programs and the Patients Over Paperwork
initiative to reduce burden, cost, and program complexity, as discussed
in section I.A.2. of the preamble of this final rule, we are adding a
new measure removal factor and removing a total of 39 measures from the
Hospital IQR Program. We are finalizing a modified version of our
proposal to remove 5 of those measures such that removal is delayed by
1 year. For a full list of measures being removed, we refer readers to
section VIII.A.5.c. of the preamble of this final rule. Beginning with
the CY 2018 reporting period/FY 2020 payment determination and
subsequent years, we are removing 17 claims-based measures and two
structural measures. Beginning with the CY 2019 reporting period/FY
2021 payment determination and subsequent years, we are removing three
chart-abstracted measures and two claims-based measures. Beginning with
the CY 2020 reporting period/FY 2022 payment determination and
subsequent years, we are removing six chart-abstracted measures, one
claims-based measure, and seven eCQMs from the Hospital IQR Program
measure set. Beginning with the CY 2021 reporting period/FY 2023
payment determination, we are removing one claims-based measure.
In addition, for the CY 2019 reporting period/FY 2021 payment
determination, we are: (1) Requiring the same eCQM reporting
requirements that were adopted for the CY 2018 reporting period/FY 2020
payment determination (82 FR 38355 through 38361), such that hospitals
submit one, self-selected calendar quarter of 2019 data for 4 eCQMs in
the Hospital IQR Program measure set; and (2) requiring that hospitals
use the 2015 Edition certification criteria for CEHRT. These changes
are in alignment with changes or current established policies under the
Medicare and Medicaid Promoting Interoperability Programs (previously
known as the Medicare and Medicaid EHR Incentive Programs). In
addition, we are summarizing public comments we received on two
measures we are considering for potential future inclusion in the
Hospital IQR Program, as well as on the potential future development
and adoption of electronic clinical quality measures generally.
i. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)
The LTCH QRP is authorized by section 1886(m)(5) of the Act and
applies to all hospitals certified by Medicare as long-term care
hospitals (LTCHs). Under the LTCH QRP, the Secretary reduces by 2
percentage points the annual update to the LTCH PPS standard Federal
rate for discharges for an LTCH during a fiscal year if the LTCH fails
to submit data in accordance with the LTCH QRP requirements specified
for that fiscal year. As part of agency-wide efforts under the
Meaningful Measures Initiative to use a parsimonious set of the most
meaningful measures for patients and clinicians in our quality programs
and the Patients Over Paperwork Initiative to reduce cost and burden
and program complexity, as discussed in section I.A.2. of the preamble
of this final rule, we are removing three measures from the LTCH QRP.
We also are adopting a new measure removal factor and are codifying the
measure removal factors in our regulations. In addition, we are
updating our regulations to expand the methods by which an LTCH is
notified of noncompliance with the requirements of the LTCH QRP for a
program year and how CMS will notify an LTCH of a reconsideration
decision.
j. Medicare and Medicaid Promoting Interoperability Programs
(Previously Referred to as Medicare and Medicaid EHR Incentive
Programs)
In this final rule, we are finalizing several changes to reduce
burden, increase interoperability and improve patient electronic access
to their health information under the Medicare and Medicaid Promoting
Interoperability Programs (previously referred to as Medicare and
Medicaid EHR Incentive Programs). Specifically, we are finalizing: (1)
An EHR reporting period of a minimum of any continuous 90 days in CYs
2019 and 2020 for new and returning participants attesting to CMS or
their State Medicaid agency; (2) modifications to our proposed
performance-based scoring methodology, which consists of a smaller set
of objectives as well as a smaller set of new and modified measures;
(3) the removal of certain CQMs beginning with the reporting period in
CY 2020 as well as the CY 2019 reporting requirements we proposed to
align the CQM reporting requirements for the Promoting Interoperability
Programs with the Hospital IQR Program; (4) the codification of
policies for subsection (d) Puerto Rico hospitals; (5) amendments to
the prior approval policy applicable in the Medicaid Promoting
Interoperability Program to align with the prior approval policy for
MMIS and ADP systems and to minimize burden on States; and (6)
deadlines for funding availability for States to conclude the Medicaid
Promoting Interoperability Program.
4. Summary of Costs and Benefits
Adjustment for MS-DRG Documentation and Coding Changes.
Section 414 of the MACRA replaced the single positive adjustment we
intended to make in FY 2018 once the recoupment required by section 631
of the ATRA was complete with a 0.5 percent positive adjustment to the
standardized amount of Medicare payments to acute care hospitals for
FYs 2018 through 2023. (The FY 2018 adjustment was subsequently
adjusted to 0.4588 percent by section 15005 of the 21st Century Cures
Act.) For FY 2019, we are making an adjustment of +0.5 percent to the
standardized amount consistent with the MACRA.
Expansion of the Postacute Care Transfer Policy. Section
53109 of the Bipartisan Budget Act of 2018 amended section
1886(d)(5)(J)(ii) of the Act to also include discharges to hospice care
by a hospice program as a qualified discharge, effective for discharges
occurring on or after October 1, 2018. Accordingly, we are making
conforming amendments to Sec. 412.4(c) of the regulation to specify
that, effective for discharges on or after October 1, 2018, if a
discharge is assigned to one of the MS-DRGs subject to the postacute
care transfer policy, and the individual is transferred to hospice care
by a hospice program, the discharge will be subject to payment as a
transfer case. We estimate that this statutory expansion to the
postacute care transfer policy will reduce Medicare payments under the
IPPS by approximately $240 million in FY 2019.
Medicare DSH Payment Adjustment and Additional Payment for
Uncompensated Care. Under section 1886(r) of the Act (as added by
section
[[Page 41151]]
3133 of the Affordable Care Act), DSH 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 receive 25 percent
of the amount they previously would have received under the 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, is 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 2019, we are updating our estimates of the three factors
used to determine uncompensated care payments. We are continuing to use
uninsured estimates produced by OACT as part of the development of the
NHEA in the calculation of Factor 2. We also are continuing to
incorporate data from Worksheet S-10 in the calculation of hospitals'
share of the aggregate amount of uncompensated care by combining data
on uncompensated care costs from Worksheet S-10 for FY 2014 and FY 2015
with proxy data regarding a hospital's share of low-income insured days
for FY 2013 to determine Factor 3 for FY 2019. To determine the amount
of uncompensated care for Puerto Rico hospitals, Indian Health Service
and Tribal hospitals, and all-inclusive rate providers, we are using
only the data regarding low-income insured days for FY 2013. In
addition, in this final rule, we are establishing the following
policies: (1) For providers with multiple cost reports beginning in the
same fiscal year, to use the longest cost report and annualize Medicaid
data and uncompensated care data if a hospital's cost report does not
equal 12 months of data; (2) in the rare case where a provider has
multiple cost reports beginning in the same fiscal year, but one report
also spans the entirety of the following fiscal year such that the
hospital has no cost report for that fiscal year, the cost report that
spans both fiscal years will be used for the latter fiscal year; and
(3) to apply statistical trim methodologies to potentially aberrant
CCRs and potentially aberrant uncompensated care costs.
We project that the amount available to distribute as payments for
uncompensated care for FY 2019 will increase by approximately $1.5
billion, as compared to the estimate of overall payments, including
Medicare DSH payments and uncompensated care payments, that will be
distributed in FY 2018. The 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 calculated payment amount is not directly tied to
a hospital's number of discharges.
Update to the LTCH PPS Payment Rates and Other Payment
Policies. Based on the best available data for the 409 LTCHs in our
database, we estimate that the changes to the payment rates and factors
that we present in the preamble and Addendum of this final rule, which
reflect the continuation of the transition of the statutory application
of the site neutral payment rate, the update to the LTCH PPS standard
Federal payment rate for FY 2019, and the one-time permanent adjustment
of approximately 0.9 percent to the LTCH PPS standard Federal payment
rate to ensure the elimination of the 25-percent threshold policy is
budget neutral, will result in an estimated increase in payments in FY
2019 of approximately $39 million.
Changes to the Hospital Readmissions Reduction Program.
For FY 2019 and subsequent years, the reduction is based on a
hospital's risk-adjusted readmission rate during a 3-year period for
acute myocardial infarction (AMI), heart failure (HF), pneumonia,
chronic obstructive pulmonary disease (COPD), total hip arthroplasty/
total knee arthroplasty (THA/TKA), and coronary artery bypass graft
(CABG). Overall, in this final rule, we estimate that 2,610 hospitals
will have their base operating DRG payments reduced by their determined
proxy FY 2019 hospital-specific readmission adjustment. As a result, we
estimate that the Hospital Readmissions Reduction Program will save
approximately $566 million in FY 2019.
Value-Based Incentive Payments under the Hospital VBP
Program. We estimate that there will be no net financial impact to the
Hospital VBP Program for the FY 2019 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 2019 program year
and, therefore, the estimated amount available for value-based
incentive payments for FY 2019 discharges is approximately $1.9
billion.
Changes to the HAC Reduction Program. 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 HAC Reduction Program changes for FY 2019, including which
hospitals will receive the adjustment, will depend on actual
experience.
The removal of NHSN HAI measures from the Hospital IQR Program and
the subsequent cessation of its validation processes for NHSN HAI
measures and the creation of a validation process for the HAC Reduction
program represent no net change in reporting burden across CMS hospital
quality programs. However, with the finalization of our proposal to
remove HAI chart-abstracted measures from the Hospital IQR Program, we
anticipate a total burden shift of 43,200 hours and approximately $1.6
million, as a result of no longer needing to validate those HAI
measures under the Hospital IQR Program and beginning the validation
process under the HAC Reduction Program.
Changes to the Hospital Inpatient Quality Reporting (IQR)
Program. Across 3,300 IPPS hospitals, we estimate that our finalized
requirements for the Hospital IQR Program in this final rule will
result in the following changes to costs and burdens related to
information collection for this program, compared to previously adopted
requirements: (1) A total collection of information burden reduction of
1,046,138 hours and a total cost reduction of approximately $38.3
million for the CY 2019 reporting period/FY 2021 payment determination,
due to the removal of ED-1, IMM-2, and VTE-6 measures; and (2) a total
collection of information burden reduction of 858,000 hours and a total
cost reduction of $31.3 million for the CY 2020 reporting period/FY
2022 payment determination due to the removal of ED-2; and (3) a total
collection of information burden reduction of 43,200 hours and a total
of $1.6 million for the CY 2021 reporting period/FY 2023 payment
determination due to validation of the NHSN HAI measures no longer
being conducted under the Hospital IQR Program once the HAC Reduction
Program begins validating these measures, as discussed
[[Page 41152]]
in the preamble of this final rule for the HAC Reduction Program.
Further, we anticipate that the removal of 39 measures will result
in a reduction in costs unrelated to information collection. For
example, it may be costly for health care providers to track the
confidential feedback, preview reports, and publicly reported
information on a measure where we use the measure in more than one
program. Also, when measures are in multiple programs, maintaining the
specifications for those measures, as well as the tools we need to
collect, validate, analyze, and publicly report the measure data may
result in costs to CMS. In addition, beneficiaries may find it
confusing to see public reporting on the same measure in different
programs. We anticipate that our finalized policies will reduce the
above-described costs.
Changes Related to the LTCH QRP. In this final rule, we
are removing two measures beginning with the FY 2020 LTCH QRP and one
measure beginning with the FY 2021 LTCH QRP, for a total of three
measures. We also are adopting a new quality measure removal factor for
the LTCH QRP. We estimate that the impact of these changes is a
reduction in costs of approximately $1,148 per LTCH annually or
approximately $482,469 for all LTCHs annually.
Changes to the Medicare and Medicaid Promoting
Interoperability Programs. We believe that, overall, the finalized
proposals in this final rule will reduce burden, as described in detail
in section XIV.B.9. of the preamble and Appendix A, section I.N. of
this final rule.
B. Background 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 training residents in an approved residency
program(s), 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. 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 an 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.
Under current law, the Medicare-dependent, small rural hospital
(MDH) program is effective through FY 2022. Through and including FY
2006, an MDH received the higher of the Federal rate or the Federal
rate plus 50 percent of the amount by which the Federal rate was
exceeded by the higher of its FY 1982 or FY 1987 hospital-specific
rate. For discharges occurring on or after October 1, 2007, but before
October 1, 2022, an MDH receives the higher of the Federal rate or the
Federal rate plus 75 percent of the amount by which the Federal rate is
exceeded by the highest of its FY 1982, FY 1987, or FY 2002 hospital-
specific rate. MDHs are a major source of care for Medicare
beneficiaries in their areas. Section 1886(d)(5)(G)(iv) of the Act
defines an MDH as a hospital that is located in a rural area (or, as
amended by the Bipartisan Budget Act of 2018, a hospital located in a
State with no rural area that meets certain statutory criteria), has
not more than 100 beds, is not an SCH, and has a high percentage of
Medicare discharges (not less than 60 percent of its inpatient days or
discharges in its cost reporting year beginning in FY 1987 or in two of
its three most recently settled Medicare cost reporting years).
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.
[[Page 41153]]
The existing regulations governing payments to hospitals under the
IPPS 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: Inpatient rehabilitation facility (IRF)
hospitals and units; long-term care hospitals (LTCHs); psychiatric
hospitals and units; children's hospitals; cancer hospitals; extended
neoplastic disease care hospitals, and hospitals located outside the 50
States, the District of Columbia, and Puerto Rico (that is, hospitals
located in the U.S. Virgin Islands, Guam, 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 IRF hospitals and units, LTCHs, and psychiatric hospitals and units
(referred to as inpatient psychiatric facilities (IPFs)). (We note that
the annual updates to the LTCH PPS are included along with the IPPS
annual update in this document. Updates to the IRF PPS and IPF PPS are
issued as separate documents.) Children's hospitals, cancer hospitals,
hospitals located outside the 50 States, the District of Columbia, and
Puerto Rico (that is, hospitals located in the U.S. Virgin Islands,
Guam, 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.
Similarly, extended neoplastic disease care hospitals are paid on a
reasonable cost basis, subject to a rate-of-increase ceiling on
inpatient operating costs.
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 sections 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 through September 30, 2015 all
LTCHs were paid 100 percent of the Federal rate. Section 1206(a) of the
Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) established the
site neutral payment rate under the LTCH PPS, which made the LTCH PPS a
dual rate payment system beginning in FY 2016. 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 are
generally paid for discharges at the site neutral payment rate unless
the discharge meets the patient criteria for payment at the LTCH PPS
standard Federal payment rate. The existing regulations governing
payment under the LTCH PPS are located in 42 CFR part 412, subpart O.
Beginning October 1, 2009, we issue the annual updates to the LTCH PPS
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) 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 Implemented in This
Final Rule
1. Pathway for SGR Reform Act of 2013 (Pub. L. 113-67)
The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) introduced
new payment rules in the LTCH PPS. Under section 1206 of this law,
discharges in cost reporting periods beginning on or after October 1,
2015, under the LTCH PPS, receive payment under a site neutral rate
unless the discharge meets certain patient-specific criteria. In this
final rule, we are continuing to update certain policies that
implemented provisions under section 1206 of the Pathway for SGR Reform
Act.
2. Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113-185)
The Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113-185), enacted on October 6, 2014, made a
number of changes that affect the Long-Term Care Hospital Quality
Reporting Program (LTCH QRP). In this final rule, we are continuing to
implement portions of section 1899B of the Act, as added by section
2(a) of the IMPACT Act, which, in part, requires LTCHs, among other
post-acute care providers, to report standardized patient assessment
data, data on quality measures, and data on resource use and other
measures.
3. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10)
Section 414 of the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA, Pub. L. 114-10) specifies a 0.5 percent positive
adjustment to the standardized amount of Medicare payments to acute
care hospitals for FYs 2018 through 2023. These adjustments follow the
recoupment adjustment to the standardized amounts under section 1886(d)
of the Act based upon the Secretary's estimates for discharges
occurring from FYs 2014 through 2017 to fully offset $11 billion, in
accordance with section 631 of the ATRA. The FY 2018 adjustment was
subsequently adjusted to 0.4588 percent by section 15005 of the 21st
Century Cures Act.
4. The 21st Century Cures Act (Pub. L. 114-255)
The 21st Century Cures Act (Pub. L. 114-255), enacted on December
13, 2016, contained the following provision affecting payments under
the Hospital Readmissions Reduction Program,
[[Page 41154]]
which we are continuing to implement in this final rule:
Section 15002, which amended section 1886(q)(3) of the Act
by adding subparagraphs (D) and (E), which requires the Secretary to
develop a methodology for calculating the excess readmissions
adjustment factor for the Hospital Readmissions Reduction Program based
on cohorts defined by the percentage of dual-eligible patients (that
is, patients who are eligible for both Medicare and full-benefit
Medicaid coverage) cared for by a hospital. In this final rule, we are
continuing to implement changes to the payment adjustment factor to
assess penalties based on a hospital's performance, relative to other
hospitals treating a similar proportion of dual-eligible patients.
5. The Bipartisan Budget Act of 2018 (Pub. L. 115-123)
The Bipartisan Budget Act of 2018 (Pub. L. 115-123), enacted on
February 9, 2018, contains provisions affecting payments under the IPPS
and the LTCH PPS, which we are implementing or continuing to implement
in this final rule:
Section 50204 amended section 1886(d)(12) of the Act to
provide for certain temporary changes to the low-volume hospital
payment adjustment policy for FYs 2018 through 2022. For FY 2018, this
provision extends the qualifying criteria and payment adjustment
formula that applied for FYs 2011 through 2017. For FYs 2019 through
2022, this provision modifies the discharge criterion and payment
adjustment formula. In FY 2023 and subsequent fiscal years, the
qualifying criteria and payment adjustment revert to the requirements
that were in effect for FYs 2005 through 2010.
Section 50205 extends the MDH program through FY 2022. It
also provides for an eligible hospital that is located in a State with
no rural area to qualify for MDH status under an expanded definition if
the hospital satisfies any of the statutory criteria at section
1886(d)(8)(E)(ii)(I), (II) (as of January 1, 2018), or (III) of the Act
to be reclassified as rural.
Section 51005(a) modified section 1886(m)(6) of the Act by
extending the blended payment rate for site neutral payment rate LTCH
discharges for cost reporting periods beginning in FY 2016 by an
additional 2 years (FYs 2018 and 2019). In addition, section 51005(b)
reduces the LTCH IPPS comparable per diem amount used in the site
neutral payment rate for FYs 2018 through 2026 by 4.6 percent. In this
final rule, we are making conforming changes to the existing
regulations.
Section 53109 modified section 1886(d)(5)(J) of the Act to
require that, beginning in FY 2019, discharges to hospice care also
qualify as a postacute care transfer and are subject to payment
adjustments.
D. Issuance of a Notice of Proposed Rulemaking
In the proposed rule that appeared in the Federal Register on May
7, 2018 (83 FR 20164), we set forth proposed payment and policy changes
to the Medicare IPPS for FY 2019 operating costs and for capital-
related costs of acute care hospitals and certain hospitals and
hospital units that are excluded from IPPS. In addition, we set forth
proposed changes to the payment rates, factors, and other payment and
policy-related changes to programs associated with payment rate
policies under the LTCH PPS for FY 2019.
Below is a general summary of the major changes that we proposed to
make in the proposed rule.
1. Proposed Changes to MS-DRG Classifications and Recalibrations of
Relative Weights
In section II. of the preamble of the proposed rule, we included--
Proposed changes to MS-DRG classifications based on our
yearly review for FY 2019.
Proposed adjustment to the standardized amounts under
section 1886(d) of the Act for FY 2019 in accordance with the
amendments made to section 7(b)(1)(B) of Public Law 110-90 by section
414 of the MACRA.
Proposed recalibration of the MS-DRG relative weights.
A discussion of the proposed FY 2019 status of new
technologies approved for add-on payments for FY 2018 and a
presentation of our evaluation and analysis of the FY 2019 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 the proposed rule, we proposed
to make revisions to the wage index for acute care hospitals and the
annual update of the wage data. Specific issues addressed include, but
are not limited to, the following:
The proposed FY 2019 wage index update using wage data
from cost reporting periods beginning in FY 2015.
Proposal regarding other wage-related costs in the wage
index.
Calculation of the proposed occupational mix adjustment
for FY 2019 based on the 2016 Occupational Mix Survey.
Analysis and implementation of the proposed FY 2019
occupational mix adjustment to the wage index for acute care hospitals.
Proposed application of the rural floor and the frontier
State floor and the proposed expiration of the imputed floor.
Proposals to codify policies regarding multicampus
hospitals.
Proposed revisions to the wage index for acute care
hospitals, based on hospital redesignations and reclassifications under
sections 1886(d)(8)(B), (d)(8)(E), and (d)(10) of the Act.
The proposed adjustment to the wage index for acute care
hospitals for FY 2019 based on commuting patterns of hospital employees
who reside in a county and work in a different area with a higher wage
index.
Determination of the labor-related share for the proposed
FY 2019 wage index.
Public comment solicitation on wage index disparities.
3. Other Decisions and Proposed Changes to the IPPS for Operating Costs
In section IV. of the preamble of the proposed rule, we discussed
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 MS-DRGs subject to the postacute care
transfer policy and special payment policy and implementation of the
statutory changes to the postacute care transfer policy.
Proposed changes to the inpatient hospital update for FY
2019.
Proposed changes related to the statutory changes to the
low-volume hospital payment adjustment policy.
Proposed updated national and regional case-mix values and
discharges for purposes of determining RRC status.
The statutorily required IME adjustment factor for FY
2019.
Proposed changes to the methodologies for determining
Medicare DSH payments and the additional payments for uncompensated
care.
Proposed changes to the effective date of SCH and MDH
classification status determinations.
Proposed changes related to the extension of the MDH
program.
Proposed changes to the rules for payment adjustments
under the
[[Page 41155]]
Hospital Readmissions Reduction Program based on hospital readmission
measures and the process for hospital review and correction of those
rates for FY 2019.
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 2019.
Proposed changes to Medicare GME affiliation agreements
for new urban teaching hospitals.
Discussion of and proposals relating to the implementation
of the Rural Community Hospital Demonstration Program in FY 2019.
Proposed revisions of the hospital inpatient admission
orders documentation requirements.
4. Proposed FY 2019 Policy Governing the IPPS for Capital-Related Costs
In section V. of the preamble to the proposed rule, we discussed
the proposed payment policy requirements for capital-related costs and
capital payments to hospitals for FY 2019.
5. Proposed Changes to the Payment Rates for Certain Excluded
Hospitals: Rate-of-Increase Percentages
In section VI. of the preamble of the proposed rule, we discussed--
Proposed changes to payments to certain excluded hospitals
for FY 2019.
Proposed changes to the regulations governing satellite
facilities.
Proposed changes to the regulations governing excluded
units of hospitals.
Proposed continued implementation of the Frontier
Community Health Integration Project (FCHIP) Demonstration.
6. Proposed Changes to the LTCH PPS
In section VII. of the preamble of the 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
2019.
Proposed changes to the blended payment rate for site
neutral payment rate cases.
Proposed elimination of the 25-percent threshold policy.
7. Proposed Changes Relating to Quality Data Reporting for Specific
Providers and Suppliers
In section VIII. of the preamble of the proposed rule, we address--
Proposed requirements for the Hospital Inpatient Quality
Reporting (IQR) Program.
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 requirements pertaining to the
clinical quality measurement for eligible hospitals and CAHs
participating in the Medicare and Medicaid Promoting Interoperability
Programs.
8. Proposed Revision to the Supporting Documentation Requirements for
an Acceptable Medicare Cost Report Submission
In section IX. of the preamble of the proposed rule, we set forth
proposed revisions to the supporting documentation required for an
acceptable Medicare cost report submission.
9. Requirements for Hospitals To Make Public List of Standard Charges
In section X. of the preamble of the proposed rule, we discussed
our efforts to further improve the public accessibility of hospital
standard charge information, effective January 1, 2019, in accordance
with section 2718(e) of the Public Health Service Act.
10. Proposed Revisions Regarding Physician Certification and
Recertification of Claims
In section XI. of the preamble of the proposed rule, we set forth
proposed revisions to the requirements for supporting information used
for physician certification and recertification of claims.
11. Request for Information
In section XII. of the preamble of the proposed rule, we included a
request for information on the possible establishment of CMS patient
health and safety requirements for hospitals and other Medicare- and
Medicaid-participating providers and suppliers for interoperable
electronic health records and systems for electronic health care
information exchange.
12. Determining Prospective Payment Operating and Capital Rates and
Rate-of-Increase Limits for Acute Care Hospitals
In sections II. and III. of the Addendum to the proposed rule, we
set forth the proposed changes to the amounts and factors for
determining the proposed FY 2019 prospective payment rates for
operating costs and capital-related costs for acute care hospitals. We
proposed to establish the threshold amounts for outlier cases. In
addition, in section IV. of the Addendum to the proposed rule, we
addressed the update factors for determining the rate-of-increase
limits for cost reporting periods beginning in FY 2019 for certain
hospitals excluded from the IPPS.
13. Determining Prospective Payment Rates for LTCHs
In section V. of the Addendum to the proposed rule, we set forth
proposed changes to the amounts and factors for determining the
proposed FY 2019 LTCH PPS standard Federal payment rate and other
factors used to determine LTCH PPS payments under both the LTCH PPS
standard Federal payment rate and the site neutral payment rate in FY
2019. We proposed to establish the adjustments for wage levels, the
labor-related share, the cost-of-living adjustment, and high-cost
outliers, including the applicable fixed-loss amounts and the LTCH
cost-to-charge ratios (CCRs) for both payment rates.
14. Impact Analysis
In Appendix A of the proposed rule, we set forth an analysis of the
impact the proposed changes would have on affected acute care
hospitals, CAHs, LTCHs, and PCHs.
15. Recommendation of Update Factors for Operating Cost Rates of
Payment for Hospital Inpatient Services
In Appendix B of the proposed rule, as required by sections
1886(e)(4) and (e)(5) of the Act, we provided our recommendations of
the appropriate percentage changes for FY 2019 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
and MDHs).
Target rate-of-increase limits to the allowable operating
costs of hospital inpatient services furnished by certain hospitals
excluded from the IPPS.
The LTCH PPS standard Federal payment rate and the site
neutral payment rate for hospital inpatient services provided for LTCH
PPS discharges.
16. 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 2018 recommendations concerning hospital inpatient
payment
[[Page 41156]]
policies addressed the update factor for hospital inpatient operating
costs and capital-related costs for hospitals under the IPPS. We
addressed these recommendations in Appendix B of the proposed rule. For
further information relating specifically to the MedPAC March 2018
report or to obtain a copy of the report, contact MedPAC at (202) 220-
3700 or visit MedPAC's website at: http://www.medpac.gov.
II. 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.
Section 1886(d)(4)(C) of the Act requires that the Secretary adjust
the DRG classifications and relative weights at least annually to
account for changes in resource consumption. 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) and the FYs 2011 through 2018 IPPS/LTCH PPS final
rules (75 FR 50053 through 50055; 76 FR 51485 through 51487; 77 FR
53273; 78 FR 50512; 79 FR 49871; 80 FR 49342; 81 FR 56787 through
56872; and 82 FR 38010 through 38085, respectively).
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. FY 2019 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 and
the Recoupment or Repayment Adjustment Authorized by Section 631 of the
American Taxpayer Relief Act of 2012 (ATRA)
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. 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 percentage
points to the national standardized amount. We provided for phasing in
this -4.8 percentage point adjustment over 3 years. Specifically, we
established prospective documentation and coding adjustments of -1.2
percentage points for FY 2008, -1.8 percentage points for FY 2009, and
-1.8 percentage points 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 percentage point
for FY 2008 and -0.9 percentage point for FY 2009.
As discussed in prior year rulemakings, and most recently in the FY
2017 IPPS/LTCH PPS final rule (81 FR 56780 through 56782), we
implemented a series of adjustments required under sections 7(b)(1)(A)
and 7(b)(1)(B) of Public Law 110-90, based on a retrospective review of
FY 2008 and FY 2009 claims data. We completed these adjustments in FY
2013 but indicated in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53274
through 53275) that delaying full implementation 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, and
that these overpayments could not be recovered under Public Law 110-90.
In addition, as discussed in prior rulemakings and most recently in
the FY 2018 IPPS/LTCH PPS final rule (82 FR 38008 through 38009),
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 represented 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.
2. Adjustment Made for FY 2018 as Required Under Section 414 of Public
Law 114-10 (MACRA) and Section 15005 of Public Law 114-255
As stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56785),
once the recoupment required under section 631 of the ATRA was
complete, we had anticipated making a single positive adjustment in FY
2018 to offset the reductions required to recoup the $11 billion under
section 631 of the ATRA. However, section 414 of the MACRA (which was
enacted on April 16, 2015) replaced the single positive adjustment we
intended to make in FY 2018 with a 0.5 percentage point positive
adjustment for each of FYs 2018 through 2023. In the FY 2017
rulemaking, we indicated that we would address the adjustments for FY
2018 and later fiscal years in future rulemaking. Section 15005 of the
21st Century Cures Act (Pub. L. 114-255), which was enacted on December
13, 2016, amended section 7(b)(1)(B) of the TMA, as amended by section
631 of the ATRA and section 414 of the MACRA, to reduce the
[[Page 41157]]
adjustment for FY 2018 from a 0.5 percentage point to a 0.4588
percentage point. As we discussed in the FY 2018 rulemaking, we believe
the directive under section 15005 of Public Law 114-255 is clear.
Therefore, in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38009) for FY
2018, we implemented the required +0.4588 percentage point adjustment
to the standardized amount. This is a permanent adjustment to payment
rates. While we did not address future adjustments required under
section 414 of the MACRA and section 15005 of Public Law 114-255 at
that time, we stated that we expected to propose positive 0.5
percentage point adjustments to the standardized amounts for FYs 2019
through 2023.
3. Adjustment for FY 2019
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20176 and 20177),
consistent with the requirements of section 414 of the MACRA, we
proposed to implement a positive 0.5 percentage point adjustment to the
standardized amount for FY 2019. We indicated that this would be a
permanent adjustment to payment rates. We stated in the proposed rule
that we plan to propose future adjustments required under section 414
of the MACRA for FYs 2020 through 2023 in future rulemaking.
Comment: Several commenters stated that CMS has misinterpreted the
Congressional directives regarding the level of positive adjustment
required for FY 2018 and FY 2019. The commenters contended that, while
the positive adjustments required under section 414 of the MACRA would
only total 3.0 percentage points by FY 2023, the levels of these
adjustments were determined using an estimated positive ``3.2 percent
baseline'' adjustment that otherwise would have been made in FY 2018.
The commenters believed that because CMS implemented an adjustment of -
1.5 percentage points instead of the expected -0.8 percentage points in
FY 2017, totaling -3.9 percentage points overall, CMS has imposed a
permanent -0.7 percentage point negative adjustment beyond its
statutory authority, contravening what the commenters asserted was
Congress' clear instructions and intent. A majority of the commenters
requested that CMS reverse its previous position and implement
additional 0.7 percentage point adjustments for both FY 2018 and FY
2019. Some of the commenters requested that CMS use its statutory
discretion to ensure that all 3.9 percentage points in negative
adjustment be restored. In addition, some of the commenters, while
acknowledging that CMS may be bound by law, expressed opposition to the
permanent reductions and requested that CMS refrain from making any
additional coding adjustments in the future.
Response: As we discussed in the FY 2019 IPPS/LTCH PPS proposed
rule, we believe section 414 of the MACRA and section 15005 of the 21st
Century Cures Act clearly set forth the levels of positive adjustments
for FYs 2018 through 2023. We are not convinced that the adjustments
prescribed by MACRA were predicated on a specific ``baseline''
adjustment level. While we had anticipated making a positive adjustment
in FY 2018 to offset the reductions required to recoup the $11 billion
under section 631 of the ATRA, section 414 of the MACRA required that
we implement a 0.5 percentage point positive adjustment for each of FYs
2018 through 2023, and not the single positive adjustment we intended
to make in FY 2018. As noted by the commenters, and discussed in the FY
2017 IPPS/LTCH PPS final rule, by phasing in a total positive
adjustment of only 3.0 percentage points, section 414 of the MACRA
would not fully restore even the 3.2 percentage points adjustment
originally estimated by CMS in the FY 2014 IPPS/LTCH PPS final rule (78
FR 50515). Moreover, as discussed in the FY 2018 IPPS/LTCH PPS final
rule, Public Law 114-255, which further reduced the positive adjustment
required for FY 2018 from 0.5 percentage point to 0.4588 percentage
point, was enacted on December 13, 2016, after CMS had proposed and
finalized the final negative -1.5 percentage points adjustment required
under section 631 of the ATRA. We see no evidence that Congress enacted
these adjustments with the intent that CMS would make an additional
+0.7 percentage point adjustment in FY 2018 to compensate for the
higher than expected final ATRA adjustment made in FY 2017.
After consideration of the public comments we received, we are
finalizing the +0.5 percentage point adjustment to the standardized
amount for FY 2019, as required under section 414 of the MACRA.
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. We also refer readers to the FY 2017 IPPS/
LTCH PPS final rule (81 FR 56785 through 56787) for a detailed
discussion of the history of changes to the number of cost centers used
in calculating the DRG relative weights. Since FY 2014, we have
calculated the IPPS MS-DRG relative weights using 19 CCRs, which now
include distinct CCRs for implantable devices, MRIs, CT scans, and
cardiac catheterization.
2. Discussion of Policy for FY 2019
Consistent with our established policy, we calculated the final MS-
DRG relative weights for FY 2019 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 19 CCRs and the MS-DRG relative
weights for FY 2019 is included in section II.G. of the preamble to
this FY 2019 IPPS/LTCH PPS final rule. As we did with the FY 2018 IPPS/
LTCH PPS final rule, for this FY 2019 final rule, we are providing the
version of the HCRIS from which we calculated these 19 CCRs on the CMS
website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Click on the link on the left
side of the screen titled ``FY 2019 IPPS Final Rule Home Page'' or
``Acute Inpatient Files for Download.''
Comment: One commenter requested that CMS use a single diagnostic
radiology CCR to set weights, rather than using the separate CT and MRI
cost centers. The commenter requested that if CMS maintains the
separate CT and MRI cost centers, CMS not include cost reports from
hospitals that use the ``square foot'' allocation methodology. The
commenter provided an analysis to support its assertion that the CCRs
for CT and MRI are incorrect and are inappropriately reducing payments
under the IPPS. The commenter indicated that the charge compression
hypothesis has been shown to be false with the use of the separate CT
and MRI cost centers. The commenter discussed problems with cost
allocation to the CT and MRI cost centers and referenced discussions in
prior IPPS/LTCH PPS rules about this issue. The commenter acknowledged
that CMS did not include a specific proposal in the FY 2019 proposed
rule regarding this issue.
[[Page 41158]]
Response: As the commenter noted, we did not make any proposal for
FY 2019 relating to the number of cost centers used to calculate the
relative weights. As noted previously and discussed in detail in prior
rulemakings, and as noted in response to a similar public comment
received last year, we have calculated the IPPS MS-DRG relative weights
using 19 CCRs, including distinct CCRs for MRIs and CT scans, since FY
2014. We refer readers to the FY 2017 IPPS/LTCH PPS final rule (81 FR
56785) for a detailed discussion of the basis for establishing these 19
CCRs. We further note that in the FY 2014 IPPS/LTCH PPS final rule (78
FR 50518 through 50523), we presented data analyses using distinct CCRs
for implantable devices, MRIs, CT scans, and cardiac catheterization.
We will continue to explore ways in which we can improve the
accuracy of the cost report data and calculated CCRs used in the cost
estimation process.
F. Changes to Specific MS-DRG Classifications
1. Discussion of Changes to Coding System and Basis for FY 2019 MS-DRG
Updates
a. Conversion of MS-DRGs to the International Classification of
Diseases, 10th Revision (ICD-10)
As of October 1, 2015, providers use the International
Classification of Diseases, 10th Revision (ICD-10) coding system to
report diagnoses and procedures for Medicare hospital inpatient
services under the MS-DRG system instead of the ICD-9-CM coding system,
which was used through September 30, 2015. 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 ICD-10-CM and ICD-10-PCS Official Guidelines for Coding and
Reporting. For a detailed discussion of the conversion of the MS-DRGs
to ICD-10, we refer readers to the FY 2017 IPPS/LTCH PPS final rule (81
FR 56787 through 56789).
b. Basis for FY 2019 MS-DRG Updates
CMS has previously encouraged input from our stakeholders
concerning the annual IPPS updates when that input was made available
to us by December 7 of the year prior to the next annual proposed rule
update. As discussed in the FY 2018 IPPS/LTCH PPS final rule (82 FR
38010), as we work with the public to examine the ICD-10 claims data
used for updates to the ICD-10 MS DRGs, we would like to examine areas
where the MS-DRGs can be improved, which will require additional time
for us to review requests from the public to make specific updates,
analyze claims data, and consider any proposed updates. Given the need
for more time to carefully evaluate requests and propose updates, we
changed the deadline to request updates to the MS-DRGs to November 1 of
each year. This will provide an additional 5 weeks for the data
analysis and review process. Interested parties had to submit any
comments and suggestions for FY 2019 by November 1, 2017, and are
encouraged to submit any comments and suggestions for FY 2020 by
November 1, 2018 via the CMS MS-DRG Classification Change Request
Mailbox located at: [email protected]. The comments
that were submitted in a timely manner for FY 2019 are discussed in
this section of the preamble of this final rule.
Following are the changes that we proposed to the MS-DRGs for FY
2019 in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20177 through
20257). We invited public comments on each of the MS-DRG classification
proposed changes, as well as our proposals to maintain certain existing
MS-DRG classifications discussed in the proposed rule. In some cases,
we proposed changes to the MS-DRG classifications based on our analysis
of claims data and consultation with our clinical advisors. In other
cases, we proposed to maintain the existing MS-DRG classifications
based on our analysis of claims data and consultation with our clinical
advisors. For the FY 2019 IPPS/LTCH PPS proposed rule, our MS-DRG
analysis was based on ICD-10 claims data from the September 2017 update
of the FY 2017 MedPAR file, which contains hospital bills received
through September 30, 2017, for discharges occurring through September
30, 2017. In our discussion of the proposed MS-DRG reclassification
changes, we referred to our analysis of claims data from the
``September 2017 update of the FY 2017 MedPAR file.''
In this FY 2019 IPPS/LTCH PPS final rule, we summarize the public
comments we received on our proposals, present our responses, and state
our final policies. For this FY 2019 final rule, we did not perform any
further MS-DRG analysis of claims data. Therefore, all of the data
analysis is based on claims data from the September 2017 update of the
FY 2017 MedPAR file, which contains bills received through September
30, 2017, for discharges occurring through September 30, 2017.
As explained in previous rulemaking (76 FR 51487), in deciding
whether to propose to make further modifications 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 represented 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 determine whether patients are clinically
distinct or similar to other patients represented 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; and
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.
We are making the FY 2019 ICD-10 MS-DRG GROUPER and Medicare Code
Editor (MCE) Software Version 36, the ICD-10 MS-DRG Definitions Manual
files Version 36 and the Definitions of Medicare Code Edits Manual
Version 36 available to the public on our CMS website at: https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-
[[Page 41159]]
Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html.
2. Pre-MDC
a. Heart Transplant or Implant of Heart Assist System
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38012), we stated
our intent to review the ICD-10 logic for Pre-MDC MS-DRGs 001 and 002
(Heart Transplant or Implant of Heart Assist System with and without
MCC, respectively), as well as MS-DRG 215 (Other Heart Assist System
Implant) and MS-DRGs 268 and 269 (Aortic and Heart Assist Procedures
Except Pulsation Balloon with and without MCC, respectively) where
procedures involving heart assist devices are currently assigned. We
also encouraged the public to submit any comments on restructuring the
MS-DRGs for heart assist system procedures to the CMS MS-DRG
Classification Change Request Mailbox located at:
[email protected] by November 1, 2017.
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20178 through 20179), the logic for Pre-MDC MS-DRGs 001 and 002 is
comprised of two lists. The first list includes procedure codes
identifying a heart transplant procedure, and the second list includes
procedure codes identifying the implantation of a heart assist system.
The list of procedure codes identifying the implantation of a heart
assist system includes the following three codes.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02HA0QZ................... Insertion of implantable heart assist system
into heart, open approach.
02HA3QZ................... Insertion of implantable heart assist system
into heart, percutaneous approach.
02HA4QZ................... Insertion of implantable heart assist system
into heart, percutaneous endoscopic
approach.
------------------------------------------------------------------------
In addition to these three procedure codes, there are also 33 pairs
of code combinations or procedure code ``clusters'' that, when reported
together, satisfy the logic for assignment to MS-DRGs 001 and 002. The
code combinations are represented by two procedure codes and include
either one code for the insertion of the device with one code for
removal of the device or one code for the revision of the device with
one code for the removal of the device. The 33 pairs of code
combinations are listed below.
----------------------------------------------------------------------------------------------------------------
Code Code description Code Code description
----------------------------------------------------------------------------------------------------------------
02HA0RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, open approach.
02HA0RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, open approach.
02HA0RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, open approach. approach.
02HA0RZ.................. Insertion of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart, open
approach. approach.
02HA0RZ.................. Insertion of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart,
approach. percutaneous approach.
02HA0RZ.................. Insertion of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart,
approach. percutaneous endoscopic
approach.
02HA3RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
approach.
02HA3RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
approach.
02HA3RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
approach.
02HA4RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
endoscopic approach.
02HA4RZ.................. Insertion of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart, open
percutaneous endoscopic approach.
approach.
02HA4RZ.................. Insertion of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart,
percutaneous endoscopic percutaneous approach.
approach.
[[Page 41160]]
02HA4RZ.................. Insertion of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart,
percutaneous endoscopic percutaneous endoscopic
approach. approach.
02WA0QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart, open
approach.
02WA0QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart,
percutaneous approach.
02WA0QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart,
percutaneous endoscopic
approach.
02WA0RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart, open
approach. approach.
02WA0RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart,
approach. percutaneous approach.
02WA0RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart,
approach. percutaneous endoscopic
approach.
02WA3QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
approach. approach.
02WA3QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous approach.
02WA3QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous endoscopic
approach.
02WA3RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart, open
percutaneous approach. approach.
02WA3RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous approach. percutaneous approach.
02WA3RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous approach. percutaneous endoscopic
approach.
02WA4QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
endoscopic approach. approach.
02WA4QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
endoscopic approach. percutaneous approach.
02WA4QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
endoscopic approach. percutaneous endoscopic
approach.
02WA4RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart, open
percutaneous endoscopic approach.
approach.
02WA4RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous endoscopic percutaneous approach.
approach.
02WA4RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous endoscopic percutaneous endoscopic
approach. approach.
----------------------------------------------------------------------------------------------------------------
In response to our solicitation for public comments on
restructuring the MS-DRGs for heart assist system procedures,
commenters recommended that CMS maintain the current logic under the
Pre-MDC MS-DRGs 001 and 002. Similar to the discussion in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38011 through 38012) involving MS-DRG
215 (Other Heart Assist System Implant), the commenters provided
examples of common clinical scenarios involving a left ventricular
assist device (LVAD) and included the procedure codes that were
reported under the ICD-9 based MS-DRGs in comparison to the procedure
codes reported under the ICD-10 MS-DRGs, which are reflected in the
following table.
----------------------------------------------------------------------------------------------------------------
ICD-9-CM procedure
Procedure code ICD-9 MS-DRG ICD-10-PCS codes ICD-10 MS-DRG
----------------------------------------------------------------------------------------------------------------
New LVAD inserted................ 37.66 (Insertion of 001 or 002 02WA0QZ (Insertion of 001 or 002
implantable heart implantable heart
assist system). assist system into
heart, open approach).
02WA3QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
approach).
02WA4QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
endoscopic approach).
[[Page 41161]]
LVAD Exchange--existing LVAD is 37.63 (Repair of 215 02PA0QZ (Removal of 001 or 002
removed and replaced with either heart assist implantable heart
new LVAD system or new LVAD pump. system). 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)
and.
02WA0QZ (Insertion of
implantable heart
assist system into
heart, open approach).
02WA3QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
approach).
02WA4QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
endoscopic approach).
LVAD revision and repair-- 37.63 (Repair of 215 02WA0QZ (Revision of 215
existing LVAD is adjusted or heart assist implantable heart
repaired without removing the system). assist system in heart,
existing LVAD device. open approach).
02WA3QZ (Revision of
implantable heart
assist system in heart,
percutaneous approach).
02WA4QZ (Revision of
implantable heart
assist system in heart,
percutaneous endoscopic
approach).
----------------------------------------------------------------------------------------------------------------
The commenters noted that, for Pre-MDC MS-DRGs 001 and 002, the
procedures involving the insertion of an implantable heart assist
system, such as the insertion of a LVAD, and the procedures involving
exchange of an LVAD (where an existing LVAD is removed and replaced
with either a new LVAD or a new LVAD pump) demonstrate clinical
similarities and utilize similar resources. Although the commenters
recommended that CMS maintain the current logic under the Pre-MDC MS-
DRGs 001 and 002, they also recommended that CMS continue to monitor
the data in these MS-DRGs for future consideration of distinctions (for
example, different approaches and evolving technologies) that may
impact the clinical and resource use of patients undergoing procedures
utilizing heart assist devices. The commenters also requested that
coding guidance be issued for assignment of the correct ICD-10-PCS
procedure codes describing LVAD exchanges to encourage accurate
reporting of these procedures.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20180), we stated
that we agree with the commenters that we should continue to monitor
the data in Pre-MDC MS-DRGs 001 and 002 for future consideration of
distinctions (for example, different approaches and evolving
technologies) that may impact the clinical and resource use of patients
undergoing procedures utilizing heart assist devices. In response to
the request that coding guidance be issued for assignment of the
correct ICD-10-PCS procedure codes describing LVAD exchanges to
encourage accurate reporting of these procedures, as we noted in the FY
2018 IPPS/LTCH PPS final rule (82 FR 38012), coding advice is issued
independently from payment policy. We also noted that, historically, we
have not provided coding advice in rulemaking with respect to policy
(82 FR 38045). We collaborate with the American Hospital Association
(AHA) through the Coding Clinic for ICD-10-CM and ICD-10-PCS to promote
proper coding. We recommended that the requestor and other interested
parties submit any questions pertaining to correct coding for these
technologies to the AHA.
In response to the public comments we received on this topic, in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20180), we provided the
results of our claims analysis from the September 2017 update of the FY
2017 MedPAR file for cases in Pre-MDC MS-DRGs 001 and 002. Our findings
are shown in the following table.
MS-DRGs for Heart Transplant or Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
MS-DRG 002--All cases........................................... 179 18.3 99,635
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 001, there were a total of 1,993
cases with an average length of stay of 35.6 days and average costs of
$185,660. For MS-DRG 002, there were a total of 179 cases with an
average length of stay of 18.3 days and average costs of $99,635.
We then examined claims data in Pre-MDC MS-DRGs 001 and 002 for
cases that reported one of the three procedure codes identifying the
implantation of a heart assist system such as the LVAD. Our findings
are shown in the following table.
MS-DRGs for Heart Transplant or Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
[[Page 41162]]
MS-DRG 001--Cases with procedure code 02HA0QZ (Insertion of 1,260 35.5 206,663
implantable heart assist system into heart, open approach).....
MS-DRG 001--Cases with procedure code 02HA3QZ (Insertion of 1 8 33,889
implantable heart assist system into heart, percutaneous
approach)......................................................
MS-DRG 001--Cases with procedure code 02HA4QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
endoscopic approach)...........................................
MS-DRG 002--All cases........................................... 179 18.3 99,635
MS-DRG 002--Cases with procedure code 02HA0QZ (Insertion of 82 19.9 131,957
implantable heart assist system into heart, open approach).....
MS-DRG 002--Cases with procedure code 02HA3QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
approach)......................................................
MS-DRG 002--Cases with procedure code 02HA4QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
endoscopic approach)...........................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 001, there were a total of 1,260
cases reporting procedure code 02HA0QZ (Insertion of implantable heart
assist system into heart, open approach) with an average length of stay
of 35.5 days and average costs of $206,663. There was one case that
reported procedure code 02HA3QZ (Insertion of implantable heart assist
system into heart, percutaneous approach) with an average length of
stay of 8 days and average costs of $33,889. There were no cases
reporting procedure code 02HA4QZ (Insertion of implantable heart assist
system into heart, percutaneous endoscopic approach). For MS-DRG 002,
there were a total of 82 cases reporting procedure code 02HA0QZ
(Insertion of implantable heart assist system into heart, open
approach) with an average length of stay of 19.9 days and average costs
of $131,957. There were no cases reporting procedure codes 02HA3QZ
(Insertion of implantable heart assist system into heart, percutaneous
approach) or 02HA4QZ (Insertion of implantable heart assist system into
heart, percutaneous endoscopic approach).
We also examined the cases in MS-DRGs 001 and 002 that reported one
of the possible 33 pairs of code combinations or clusters. Our findings
are shown in the following 8 tables. The first table provides the total
number of cases reporting a procedure code combination (or cluster)
compared to all of the cases in the respective MS-DRG, followed by
additional detailed tables showing the number of cases, average length
of stay, and average costs for each specific code combination that was
reported in the claims data.
Heart Transplant or Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRGs 001 and 002 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
MS-DRG 001--Cases with a procedure code combination (cluster)... 149 28.4 179,607
MS-DRG 002--All cases........................................... 179 18.3 99,635
MS-DRG 002--Cases with a procedure code combination (cluster)... 6 3.8 57,343
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RS (Insertion of 3 20.3 $121,919
biventricular short-term external heart assist system into
heart, open approach) with 02PA0RZ (Removal of short-term
external heart assist system from heart, open approach)........
Cases with a procedure code combination of 02HA0RS (Insertion of 2 12 114,688
biventricular short-term external heart assist system into
heart, open approach) with 02PA3RZ (Removal of short-term
external heart assist system from heart, percutaneous approach)
All cases reporting one or more of the above procedure code 5 17 119,027
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RZ (Insertion of 30 55.6 $351,995
short-term external heart assist system into heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02HA0RZ (Insertion of 19 29.8 191,163
short-term external heart assist system into heart, open
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
[[Page 41163]]
All cases reporting one or more of the above procedure code 49 45.6 289,632
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RZ (Insertion of 1 4 48,212
short-term external heart assist system into heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02HA0RZ (Insertion of 2 4.5 66,386
short-term external heart assist system into heart, open
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 3 4.3 60,328
combinations in MS-DRG 002.....................................
All cases reporting one or more of the above procedure code 52 43.3 276,403
combinations across both MS-DRGs 001 and 002...................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA3RS (Insertion of 3 43.3 $233,330
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA0RZ (Removal of short-
term external heart assist system from heart, open approach)...
Cases with a procedure code combination of 02HA3RS (Insertion of 24 14.8 113,955
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA3RZ (Removal of short-
term external heart assist system from heart, percutaneous
approach)......................................................
Cases with a procedure code combination of 02HA3RS (Insertion of 1 44 153,284
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA4RZ (Removal of short-
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
All cases reporting one or more of the above procedure code 28 18.9 128,150
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA3RS (Insertion of 2 4 30,954
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA3RZ (Removal of short-
term external heart assist system from heart, percutaneous
approach)......................................................
All cases reporting one of the above procedure code combinations 2 4 30,954
in MS-DRG 002..................................................
All cases reporting one or more of the above procedure code 30 17.9 121,670
combinations across both MS[dash]DRGs 001 and 002..............
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA4RZ (Insertion of 4 17.3 $154,885
short-term external heart assist system into heart,
percutaneous endoscopic approach) with 02PA3RZ (Removal of
short-term external heart assist system from heart,
percutaneous approach).........................................
Cases with a procedure code combination of 02HA4RZ (Insertion of 2 15.5 80,852
short-term external heart assist system into heart, open
approach with 02PA4RZ (Removal of short-term external heart
assist system from heart, percutaneous endoscopic approach)....
All cases reporting one or more of the above procedure code 6 16.7 130,207
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA0QZ (Revision of 1 105 $516,557
implantable heart assist system in heart, open approach) with
02PA0RZ (Removal of short-term external heart assist system
from heart, open approach).....................................
----------------------------------------------------------------------------------------------------------------
[[Page 41164]]
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA0RZ (Revision of 2 40 $285,818
short-term external heart assist system in heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02WA0RZ (Revision of 1 43 372,673
short-term external heart assist system in heart, open
approach) with 02PA03Z (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 3 41 314,770
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA3RZ (Revision of 2 24 $123,084
short-term external heart assist system in heart, percutaneous
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02WA3RZ (Revision of 55 14.7 104,963
short-term external heart assist system in heart, percutaneous
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 57 15 105,599
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA3RZ (Revision of 1 2 101,168
short-term external heart assist system in heart, percutaneous
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 58 14.8 105,522
combinations across both MS-DRGs 001 and 002...................
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA4RZ (Revision of 1 10 112,698
short-term external heart assist system in heart, percutaneous
endoscopic approach) with 02PA0RZ (Removal of short-term
external heart assist system from heart, open approach)........
----------------------------------------------------------------------------------------------------------------
We did not find any cases reporting the following procedure code
combinations (clusters) in the claims data.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
02HA4RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
endoscopic approach.
02WA3QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
approach. approach.
02WA3QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous approach.
02WA3QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous endoscopic
approach.
----------------------------------------------------------------------------------------------------------------
The data show that there are differences in the average length of
stay and average costs for cases in Pre-MDC MS-DRGs 001 and 002
according to the type of procedure (insertion, revision, or removal),
the type of device (biventricular short-term external heart assist
system, short-term external heart assist system or implantable heart
assist system), and the approaches that were utilized (open,
percutaneous, or percutaneous endoscopic). In the FY 2019 IPPS/LTCH PPS
proposed rule, we agreed with the commenters' recommendation to
maintain the structure of Pre-MDC MS-DRGs 001 and 002 for FY 2019 and
stated that we would continue to analyze the claims data.
Comment: Commenters supported CMS' proposal to maintain the current
structure of Pre-MDC MS-DRGs 001 and 002 for FY 2019, and to continue
to analyze claims data for consideration of
[[Page 41165]]
future modifications. The commenters agreed with CMS that current
claims data do not yet reflect recent advice published in Coding Clinic
for ICD-10-CM/PCS regarding the coding of procedures involving external
heart assist devices or recent changes to ICD-10-PCS codes for these
procedures.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
maintaining the current structure of Pre-MDC MS-DRGs 001 and 002 for FY
2019.
Commenters also suggested that CMS maintain the current logic for
MS-DRG 215 (Other Heart Assist System Implant), but they recommended
that CMS continue to monitor the data in MS-DRG 215 for future
consideration of distinctions (for example, different approaches and
evolving technologies) that may impact the clinical and resource use of
procedures utilizing heart assist devices. As discussed in the FY 2019
IPPS/LTCH PPS proposed rule (83 FR 20184), we also received a request
to review claims data for procedures involving extracorporeal membrane
oxygenation (ECMO) in combination with the insertion of a percutaneous
short-term external heart assist device to determine if the current MS-
DRG assignment is appropriate.
The logic for MS-DRG 215 is comprised of the procedure codes shown
in the following table, for which we examined claims data in the
September 2017 update of the FY 2017 MedPAR file in response to the
commenters' requests. Our findings are shown in the following table.
MS-DRG 215
[Other Heart Assist System Implant]
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases....................................................... 3,428 8.7 $68,965
Cases with procedure code 02HA0RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative, open
approach)......................................................
Cases with procedure code 02HA0RS (Insertion of biventricular 9 10 118,361
short-term external heart assist system into heart, open
approach)......................................................
Cases with procedure code 02HA0RZ (Insertion of short-term 66 11.5 99,107
external heart assist system into heart, open approach)........
Cases with procedure code 02HA3RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative,
percutaneous approach).........................................
Cases with procedure code 02HA3RS (Insertion of biventricular 117 7.2 64,302
short-term external heart assist system into heart,
percutaneous approach).........................................
Cases with procedure code 02HA3RZ (Insertion of short-term 3,136 8.4 67,670
external heart assist system into heart, percutaneous approach)
Cases with procedure code 02HA4RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative,
percutaneous endoscopic approach)..............................
Cases with procedure code 02HA4RS (Insertion of biventricular 1 2 43,988
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
Cases with procedure code 02HA4RZ (Insertion of short-term 31 5.3 57,042
external heart assist system into heart, percutaneous
endoscopic approach)...........................................
Cases with procedure code 02WA0JZ (Revision of synthetic 1 84 366,089
substitute in heart, open approach)............................
Cases with procedure code 02WA0QZ (Revision of implantable heart 56 25.1 123,410
assist system in heart, open approach).........................
Cases with procedure code 02WA0RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, open
approach)......................................................
Cases with procedure code 02WA0RZ (Revision of short-term 8 13.5 99,378
external heart assist system in heart, open approach)..........
Cases with procedure code 02WA3QZ (Revision of implantable heart 0 0 0
assist system in heart, percutaneous approach).................
Cases with procedure code 02WA3RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, percutaneous
approach)......................................................
Cases with procedure code 02WA3RZ (Revision of short-term 80 10 71,077
external heart assist system in heart, percutaneous approach)..
Cases with procedure code 02WA4QZ (Revision of implantable heart 0 0 0
assist system in heart, percutaneous endoscopic approach)......
Cases with procedure code 02WA4RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, percutaneous
endoscopic approach)...........................................
Cases with procedure code 02WA4RZ (Revision of short-term 0 0 0
external heart assist system in heart, percutaneous endoscopic
approach)......................................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 215, we found a total of 3,428
cases with an average length of stay of 8.7 days and average costs of
$68,965. For procedure codes describing the insertion of a
biventricular short-term external heart assist system with open,
percutaneous or percutaneous endoscopic approaches, we found a total of
127 cases with an average length of stay ranging from 2 to 10 days and
average costs ranging from $43,988 to $118,361. For procedure codes
describing the insertion of a short-term external heart assist system
with open, percutaneous or percutaneous endoscopic approaches, we found
a total of 3,233 cases with an average length of stay ranging from 5.3
days to 11.5 days and average costs ranging from $57,042 to $99,107.
For procedure codes describing the revision of a short-term external
heart assist system with open or percutaneous approaches, we found a
total of 88 cases with an average length of stay ranging from 10 to
13.5 days and average costs ranging from $71,077 to $99,378. We found 1
case
[[Page 41166]]
reporting procedure code 02WA0JZ (Revision of synthetic substitute in
heart, open approach), with an average length of stay of 84 days and
average costs of $366,089. Lastly, we found 56 cases reporting
procedure code 02WA0QZ (Revision of implantable heart assist system in
heart, open approach) with an average length of stay of 25.1 days and
average costs of $123,410.
As the data show, there is a wide range in the average length of
stay and the average costs for cases reporting procedures that involve
a biventricular short-term external heart assist system versus a short-
term external heart assist system. There is an even greater range in
the average length of stay and the average costs when comparing the
revision of a short-term external heart assist system to the revision
of a synthetic substitute in the heart or to the revision of an
implantable heart assist system.
In the proposed rule, we stated that we agreed with the commenters
that continued monitoring of the data and further analysis is necessary
prior to proposing any modifications to MS-DRG 215. As stated in the FY
2018 IPPS/LTCH PPS final rule (82 FR 38012), we are aware that the AHA
published Coding Clinic advice that clarified coding and reporting for
certain external heart assist devices due to the technology being
approved for new indications. The current claims data do not yet
reflect that updated guidance. We also noted that there have been
recent updates to the descriptions of the codes for heart assist
devices in the past year. For example, the qualifier ``intraoperative''
was added effective October 1, 2017 (FY 2018) to the procedure codes
describing the insertion of short-term external heart assist system
procedures to distinguish between procedures where the device was only
used intraoperatively and was removed at the conclusion of the
procedure versus procedures where the device was not removed at the
conclusion of the procedure and for which that qualifier would not be
reported. The current claims data do not yet reflect these new
procedure codes, which are displayed in the following table and are
assigned to MS-DRG 215.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02HA0RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
open approach.
02HA3RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
percutaneous approach.
02HA4RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
percutaneous endoscopic approach.
------------------------------------------------------------------------
In the proposed rule, we indicated that our clinical advisors also
agreed that additional claims data are needed for analysis prior to
proposing any changes to MS-DRG 215. Therefore, we did not propose to
make any modifications to MS-DRG 215 for FY 2019.
Comment: Commenters supported CMS' proposal to not make any
modifications to MS-DRG 215 for FY 2019 and supported continued
analysis of claims data for consideration of modifications in future
rulemaking. The commenters noted that the proposal was reasonable,
given the data, the ICD-10-PCS procedure codes, and information
provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current structure of MS-DRG 215
for FY 2019.
As stated in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20185)
and earlier in this section, we also received a request to review cases
reporting the use of ECMO in combination with the insertion of a
percutaneous short-term external heart assist device. Under ICD-10-PCS,
ECMO is identified with procedure code 5A15223 (Extracorporeal membrane
oxygenation, continuous) and the insertion of a percutaneous short-term
external heart assist device is identified with procedure code 02HA3RZ
(Insertion of short-term external heart assist system into heart,
percutaneous approach). According to the commenter, when ECMO
procedures are performed percutaneously, they are less invasive and
less expensive than traditional ECMO. The commenter also noted that,
currently under ICD-10-PCS, there is not a specific procedure code to
identify percutaneous ECMO, and providers are only able to report ICD-
10-PCS procedure code 5A15223, which may be inappropriately resulting
in a higher paying MS-DRG. Therefore, the commenter submitted a
separate request to create a new ICD-10-PCS procedure code specifically
for percutaneous ECMO which was discussed at the March 6-7, 2018 ICD-10
Coordination and Maintenance Committee Meeting. We refer readers to
section II.F.18. of the preamble of this final rule for further
information regarding this meeting and the discussion for a new
procedure code.
The requestor suggested that cases reporting a procedure code for
ECMO in combination with the insertion of a percutaneous short-term
external heart assist device could be reassigned from Pre-MDC MS-DRG
003 (ECMO or Tracheostomy with Mechanical Ventilation >96 Hours or
Principal Diagnosis Except Face, Mouth and Neck with Major O.R.
Procedure) to MS-DRG 215. Our analysis involved examining cases in Pre-
MDC MS-DRG 003 in the September 2017 update of the FY 2017 MedPAR file
for cases reporting ECMO with and without the insertion of a
percutaneous short-term external heart assist device. Our findings are
shown in the following table.
ECMO and Percutaneous Short-Term External Heart Assist Device
----------------------------------------------------------------------------------------------------------------
Number of Average length
Pre-MDC MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 003--All cases........................................... 14,383 29.5 $118,218
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 1,786 19 119,340
membrane oxygenation, continuous)..............................
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 94 11.4 110,874
membrane oxygenation, continuous) and 02HA3RZ (Insertion of
short-term external heart assist system into heart,
percutaneous approach).........................................
[[Page 41167]]
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 1 1 64,319
membrane oxygenation, continuous) and 02HA4RZ (Insertion of
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 14,383 cases with an
average length of stay of 29.5 days and average costs of $118,218 in
Pre-MDC MS-DRG 003. We found 1,786 cases reporting procedure code
5A15223 (Extracorporeal membrane oxygenation, continuous) with an
average length of stay of 19 days and average costs of $119,340. We
found 94 cases reporting procedure code 5A15223 and 02HA3RZ (Insertion
of short-term external heart assist system into heart, percutaneous
approach) with an average length of stay of 11.4 days and average costs
of $110,874. Lastly, we found 1 case reporting procedure code 5A15223
and 02HA4RZ (Insertion of short-term external heart assist system into
heart, percutaneous endoscopic approach) with an average length of stay
of 1 day and average costs of $64,319.
We also reviewed the cases in MS-DRG 215 for procedure codes
02HA3RZ and 02HA4RZ. Our findings are shown in the following table.
Percutaneous Short-Term External Heart Assist Device
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 215--All cases........................................... 3,428 8.7 $68,965
MS-DRG 215--Cases with procedure code 02HA3RZ (Insertion of 3,136 8.4 67,670
short-term external heart assist system into heart,
percutaneous approach).........................................
MS-DRG 215--Cases with procedure code 02HA4RZ (Insertion of 31 5.3 57,042
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 3,428 cases with an
average length of stay of 8.7 days and average costs of $68,965. We
found a total of 3,136 cases reporting procedure code 02HA3RZ with an
average length of stay of 8.4 days and average costs of $67,670. We
found a total of 31 cases reporting procedure code 02HA4RZ with an
average length of stay of 5.3 days and average costs of $57,042.
We stated in the proposed rule that, for Pre-MDC MS-DRG 003, while
the average length of stay and average costs for cases where procedure
code 5A15223 was reported with procedure code 02HA3RZ or procedure code
02HA4RZ are lower than the average length of stay and average costs for
cases where procedure code 5A15223 was reported alone, we are unable to
determine from the data if those ECMO procedures were performed
percutaneously in the absence of a unique code. In addition, the one
case reporting procedure code 5A15223 with 02HA4RZ only had a 1 day
length of stay and it is unclear from the data what the circumstances
of that case may have involved. For example, the patient may have been
transferred or may have expired. Therefore, in the FY 2019 IPPS/LTCH
PPS proposed rule (83 FR 20186), we proposed to not reassign cases
reporting procedure code 5A15223 when reported with procedure code
02HA3RZ or procedure code 02HA4RZ for FY 2019. We stated in the
proposed rule that our clinical advisors agreed that until there is a
way to specifically identify percutaneous ECMO in the claims data to
enable further analysis, a proposal at this time is not warranted.
Comment: Commenters supported CMS' proposal to not reassign cases
reporting the use of ECMO (procedure code 5A15223) in combination with
the insertion of a percutaneous short-term external heart assist device
(procedure code 02HA3RZ or procedure code 02HA4RZ) for FY 2019.
Response: We appreciate the commenters' support.
Comment: Other commenters acknowledged that new ICD-10-PCS
procedure codes that identify percutaneous ECMO procedures were made
publicly available in May 2018. The commenters suggested that the new
procedure codes be assigned to MS-DRGs that reflect cases representing
patients with similar clinical characteristics and whose treatment
requires similar resource utilization, such as MS-DRG 215. Some
commenters specifically requested that the new procedure code
describing a percutaneous veno-arterial (VA) ECMO procedure be
considered for assignment to MS-DRG 215 versus Pre-MDC MS-DRG 003
because MS-DRG 215 is the primary MS-DRG for procedures involving the
implantation of peripheral heart assist pumps, with similar cases
representing patient conditions and clinical coherence. The commenters
noted that the percutaneous ECMO procedure is less invasive and less
expensive than the traditional ECMO procedure, and has the clinical
similarities and requires similar resource utilization as procedures
currently assigned to MS-DRG 215, such as the percutaneous ventricular
assist devices procedure.
Another commenter suggested that CMS should assign cases
representing patients receiving treatment involving the peripheral VA
ECMO procedure to MS-DRG 215 or another MS-DRG within MDC 5. The
commenter stated that cases representing patients currently assigned to
MS-DRG 215 are clinically coherent to the characteristics of the
patients who undergo a peripheral VA ECMO procedure. Another commenter
recommended that the new procedure code describing a percutaneous veno-
venous (VV) ECMO procedure be considered for assignment to MS-DRG 004
or another MS-DRG within MDC 4 because the indication is to provide
respiratory support.
Response: The commenters are correct that the FY 2019 ICD-10-PCS
procedure code files (which are available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-PCS.html) include new ICD-10-PCS procedure codes that identify
percutaneous ECMO procedures. In addition, the files also show that the
current code for ECMO
[[Page 41168]]
procedures (ICD-10-PCS code 5A15223) has been revised. These new
procedure codes, and the revised ECMO procedure code and description,
effective October 1, 2018, are shown in the following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
5A1522F............................. Extracorporeal Oxygenation,
Membrane, Central.
5A1522G............................. Extracorporeal Oxygenation,
Membrane, Peripheral Veno-
arterial.
5A1522H............................. Extracorporeal Oxygenation,
Membrane, Peripheral Veno-venous.
------------------------------------------------------------------------
In response to the commenters' suggestions to assign the new
procedure codes for percutaneous ECMO procedures to MS-DRG 215, we note
that the new procedure codes created to describe percutaneous ECMO
procedures were not finalized at the time of the proposed rule. In
addition, the deletion of the current procedure code for ECMO (ICD-10-
PCS code 5A15223) and the creation of the new procedure code for
central ECMO were not finalized at the time of the proposed rule. As
these codes were not finalized at the time of the proposed rule, they
were not reflected in Table 6B.--New Procedure Codes (which is
available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) associated with the FY 2019 IPPS/LTCH PPS
proposed rule. Therefore, because these procedure codes were not yet
approved, there were no proposed MDC, MS-DRG, or O.R. and non-O.R.
designations for these new procedure codes.
Consistent with our annual process of assigning new procedure codes
to MDCs and MS-DRGs, and designating a procedure as an O.R. or non-O.R.
procedure, we reviewed the predecessor procedure code assignments. The
predecessor procedure code (ICD-10-PCS code 5A15223) for the new
percutaneous ECMO procedure codes describes an open approach which
requires an incision along the sternum (sternotomy) and is performed
for open heart surgery. It is considered extremely invasive and carries
significant risks for complications, including bleeding, infection, and
vessel injury. For central ECMO, arterial cannulation typically occurs
directly into the ascending aorta and venous cannulation occurs
directly into the right atrium. Conversely, percutaneous (peripheral)
ECMO does not require a sternotomy and can be performed in the
intensive care unit or at the bedside. The cannulae are placed
percutaneously and can utilize a variety of configurations, according
to the indication (VA or VV) and patient age (adult vs. pediatric).
While percutaneous ECMO also carries risks, they differ from those of
central ECMO. For example, our clinical advisor note that patients
receiving percutaneous ECMO are at a greater risk of suffering vascular
complications.
Upon review, our clinical advisors do not support assigning the new
procedure codes for peripheral ECMO procedures to the same MS-DRG as
the predecessor code for open (central) ECMO in Pre-MDC MS-DRG 003. Our
clinical advisors also do not agree with designating percutaneous ECMO
procedures as O.R. procedures because they are less resource intensive
compared to open ECMO procedures. As shown in Table 6B.--New Procedure
Codes associated with this final rule (which is available via the
internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html), the new
procedure codes for percutaneous ECMO procedures have been designated
as non-O.R. procedures that will affect the MS-DRG assignment for
specific medical MS-DRGs. Effective October 1, 2018, the MS-DRGs for
which the percutaneous ECMO procedures will affect MS-DRG assignment
are shown in the following table, along with the revised MS-DRG titles.
------------------------------------------------------------------------
MDC MS-DRG MS-DRG title
------------------------------------------------------------------------
4.......................... 207 Respiratory System
Diagnosis with Ventilator
Support >96 Hours or
Peripheral Extracorporeal
Membrane Oxygenation
(ECMO).
5.......................... 291 Heart Failure and Shock
with MCC or Peripheral
Extracorporeal Membrane
Oxygenation (ECMO).
5.......................... 296 Cardiac Arrest, Unexplained
with MCC or Peripheral
Extracorporeal Membrane
Oxygenation (ECMO).
18......................... 870 Septicemia or Severe Sepsis
with MV >96 Hours or
Peripheral Extracorporeal
Membrane Oxygenation
(ECMO).
------------------------------------------------------------------------
Our clinical advisors support the designation of the peripheral
ECMO procedures as a non-O.R. procedure affecting the MS-DRG assignment
of MS-DRG 207 because they consider the procedure to be similar to
providing mechanical ventilation greater than 96 hours in terms of both
clinical severity and resource use. Because any respiratory diagnosis
classified under MDC 4 with mechanical ventilation greater than 96
hours is assigned to MS-DRG 207, it is reasonable to expect that any
patient with a respiratory diagnosis who requires treatment involving a
peripheral ECMO procedure should also be assigned to MS-DRG 207. The
same rationale was applied for MS-DRG 870, which also includes
mechanical ventilation greater than 96 hours. In addition, based on the
common clinical indications for which a percutaneous ECMO procedure is
utilized, such as cardiogenic shock and cardiac arrest, our clinical
advisors determined that MS-DRGs 291 (Heart Failure and Shock with MCC)
and 296 (Cardiac Arrest, Unexplained with MCC) also are appropriate for
a percutaneous ECMO procedure to affect the MS-DRG assignment. The MS-
DRG assignment for a central ECMO procedure will remain in Pre-MDC MS-
DRG 003.
In cases where a percutaneous external heart assist device is
utilized, in combination with a percutaneous ECMO procedure, effective
October 1, 2018, the ICD-10 MS-DRG Version 36 GROUPER logic results in
a case assignment to MS-DRG 215 because the percutaneous external heart
assist device procedure is designated as an O.R. procedure and assigned
to MS-DRG 215.
Because the procedure codes describing percutaneous ECMO procedures
are new, becoming effective October 1, 2018, we do not yet have any
claims data to analyze. Once claims data becomes available, we can
examine the
[[Page 41169]]
volume, and length of stay and cost data to determine if modifications
to the assignment of these procedure codes are warranted.
After consideration of the public comments we received, we are
finalizing our proposal to not reassign cases reporting ICD-10-PCS
procedure code 5A15223 when reported with ICD-10-PCS procedure code
02HA3RZ or ICD-10-PCS procedure code 02HA4RZ for FY 2019. Consistent
with our policy for determining MS-DRG assignment for new codes and for
the reasons discussed, the two new procedure codes describing
percutaneous ECMO procedures discussed and displayed in the table
above, under the ICD-10 MS-DRGs Version 36 GROUPER logic, effective
October 1, 2018, are designated as non-O.R. procedures impacting the
MS-DRG assignment of MS-DRGs 207, 291, 296, and 870. The MS-DRG
assignment for the central ECMO procedure remains in Pre-MDC MS-DRG
003.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20186), we also
discussed that a commenter also suggested that CMS maintain the current
logic for MS-DRGs 268 and 269 (Aortic and Heart Assist Procedures
Except Pulsation Balloon with and without MCC, respectively), but
recommended that CMS continue to monitor the data in these MS-DRGs for
future consideration of distinctions (for example, different approaches
and evolving technologies) that may impact the clinical and resource
use of procedures involving heart assist devices.
The logic for heart assist system devices in MS-DRGs 268 and 269 is
comprised of the procedure codes shown in the following table, for
which we examined claims data in the September 2017 update of the FY
2017 MedPAR file in response to the commenter's request. Our findings
are shown in the following table.
MS-DRGs for Aortic and Heart Assist Procedures Except Pulsation Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 268--All cases........................................... 3,798 9.6 $49,122
MS-DRG 268--Cases with procedure code 02PA0QZ (Removal of 16 23.4 79,850
implantable heart assist system from heart, open approach).....
MS-DRG 268--Cases with procedure code 02PA0RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, open approach)..........................................
MS-DRG 268--Cases with procedure code 02PA0RZ (Removal of short- 0 0 0
term external heart assist system from heart, open approach)...
MS-DRG 268--Cases with procedure code 02PA3QZ (Removal of 28 10.5 31,797
implantable heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 268--Cases with procedure code 02PA3RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous approach)..................................
MS-DRG 268--Cases with procedure code 02PA3RZ (Removal of short- 96 12.4 51,469
term external heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 268--Cases with procedure code 02PA4QZ (Removal of 5 7.8 37,592
implantable heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 268--Cases with procedure code 02PA4RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous endoscopic approach).......................
MS-DRG 268--Cases with procedure code 02PA4RZ (Removal of short- 0 0 0
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 269--All cases........................................... 16,900 2.4 30,793
MS-DRG 269--Cases with procedure code 02PA0QZ (Removal of 10 8 23,741
implantable heart assist system from heart, open approach).....
MS-DRG 269--Cases with procedure code 02PA0RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, open approach)..........................................
MS-DRG 269--Cases with procedure code 02PA0RZ (Removal of short- 0 0 0
term external heart assist system from heart, open approach)...
MS-DRG 269--Cases with procedure code 02PA3QZ (Removal of 6 5 19,421
implantable heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 269--Cases with procedure code 02PA3RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous approach)..................................
MS-DRG 269--Cases with procedure code 02PA3RZ (Removal of short- 11 4 25,719
term external heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 269--Cases with procedure code 02PA4QZ (Removal of 1 3 14,415
implantable heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 269--Cases with procedure code 02PA4RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous endoscopic approach).......................
MS-DRG 269--Cases with procedure code 02PA4RZ (Removal of short- 0 0 0
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 268, there were a total of 3,798
cases, with an average length of stay of 9.6 days and average costs of
$49,122. There were 16 cases reporting procedure code 02PA0QZ (Removal
of implantable heart assist system from heart, open approach), with an
average length of stay of 23.4 days and average costs of $79,850. There
were no cases that reported procedure codes 02PA0RS (Removal of
biventricular short-term external heart assist system from heart, open
approach), 02PA0RZ (Removal of short-term external heart assist system
from heart, open approach), 02PA3RS (Removal of biventricular short-
term external heart assist system from heart, percutaneous approach),
02PA4RS (Removal of biventricular short-term external heart assist
system from heart, percutaneous endoscopic approach) or 02PA4RZ
(Removal of short-term external heart assist system from heart,
percutaneous endoscopic approach). There were 28 cases reporting
procedure code 02PA3QZ (Removal of implantable
[[Page 41170]]
heart assist system from heart, percutaneous approach), with an average
length of stay of 10.5 days and average costs of $31,797. There were 96
cases reporting procedure code 02PA3RZ (Removal of short-term external
heart assist system from heart, percutaneous approach), with an average
length of stay of 12.4 days and average costs of $51,469. There were 5
cases reporting procedure code 02PA4QZ (Removal of implantable heart
assist system from heart, percutaneous endoscopic approach), with an
average length of stay of 7.8 days and average costs of $37,592. For
MS-DRG 269, there were a total of 16,900 cases, with an average length
of stay of 2.4 days and average costs of $30,793. There were 10 cases
reporting procedure code 02PA0QZ (Removal of implantable heart assist
system from heart, open approach), with an average length of stay of 8
days and average costs of $23,741. There were no cases reporting
procedure codes 02PA0RS (Removal of biventricular short-term external
heart assist system from heart, open approach), 02PA0RZ (Removal of
short-term external heart assist system from heart, open approach),
02PA3RS (Removal of biventricular short-term external heart assist
system from heart, percutaneous approach), 02PA4RS (Removal of
biventricular short-term external heart assist system from heart,
percutaneous endoscopic approach) or 02PA4RZ (Removal of short-term
external heart assist system from heart, percutaneous endoscopic
approach). There were 6 cases reporting procedure code 02PA3QZ (Removal
of implantable heart assist system from heart, percutaneous approach),
with an average length of stay of 5 days and average costs of $19,421.
There were 11 cases reporting procedure code 02PA3RZ (Removal of short-
term external heart assist system from heart, percutaneous approach),
with an average length of stay of 4 days and average costs of $25,719.
There was 1 case reporting procedure code 02PA4QZ (Removal of
implantable heart assist system from heart, percutaneous endoscopic
approach), with an average length of stay of 3 days and average costs
of $14,415.
The data show that there are differences in the average length of
stay and average costs for cases in MS-DRGs 268 and 269 according to
the type of device (short-term external heart assist system or
implantable heart assist system), and the approaches that were utilized
(open, percutaneous, or percutaneous endoscopic). In the proposed rule,
we stated that we agreed with the recommendation to maintain the
structure of MS-DRGs 268 and 269 for FY 2019 and will continue to
analyze the claims data for possible future updates. As such, we
proposed to not make any changes to the structure of MS-DRGs 268 and
269 for FY 2019.
Comment: Commenters supported CMS' proposal to not make any changes
to the structure of MS-DRGs 268 and 269 for FY 2019.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the structure of MS-DRGs 268 and
269 for FY 2019.
b. Brachytherapy
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20188), we received a request to create a new Pre-MDC MS-DRG for all
procedures involving the CivaSheet[supreg] technology, an implantable,
planar brachytherapy source designed to enable delivery of radiation to
the site of the cancer tumor excision or debulking, while protecting
neighboring tissue. The requestor stated that physicians have used the
CivaSheet[supreg] technology for a number of indications, such as
colorectal, gynecological, head and neck, soft tissue sarcomas and
pancreatic cancer. The requestor noted that potential uses also include
nonsmall-cell lung cancer, ocular melanoma, and atypical meningioma.
Currently, procedures involving the CivaSheet[supreg] technology are
reported using ICD-10-PCS Section D--Radiation Therapy codes, with the
root operation ``Brachytherapy.'' These codes are non-O.R. codes and
group to the MS-DRG to which the principal diagnosis is assigned.
In response to this request, we analyzed claims data from the
September 2017 update of the FY 2017 MedPAR file for cases representing
patients who received treatment that reported low dose rate (LDR)
brachytherapy procedure codes across all MS-DRGs. We referred readers
to Table 6P.--ICD-10-CM and ICD-10-PCS Codes for Proposed MS-DRG
Changes associated with the proposed rule, which is available via the
internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. A detailed list
of these procedure codes was shown in Table 6P.1.associated with the
proposed rule. Our findings are reflected in the following table. As we
note below in response to comments, there were errors in the table
included in the proposed rule (83 FR 20188) with regard to an
identified MS-DRG and procedure code. However, there were no errors in
the data findings reported. In the proposed rule, we identified claims
data for MS-DRG 129 with procedure code D710BBZ (Low dose rate (LDR)
brachytherapy of bone marrow using Palladium-103 (Pd-103)). That entry
was an inadventent error. The correct MS-DRG, that is, MS-DRG 054, and
procedure code, that is, D010BBZ, are reflected in the table that
follows. In addition, in the proposed rule we inadvertently identified
MS-DRG 724 with procedure code DV10BBZ (Low dose rate (LDR)
brachytherapy of prostate using Palladium 103 (Pd-103)). Upon review,
this case was actually reported with MS-DRG 189. The data findings
identified for each of these 4 cases are correctly reflected in the
table that follows.
Cases Reporting Low Dose Rate (LDR) Brachytherapy Procedure Codes Across All MS-DRGs
----------------------------------------------------------------------------------------------------------------
Number of Average length
ICD-10-PCS procedures cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 054 (Nervous System Neoplasms with CC)--Cases with 1 7 $10,357
procedure code D010BBZ (Low dose rate (LDR) brachytherapy of
brain using Palladium[dash]103 (Pd-103)).......................
MS-DRG 189 (Pulmonary Edema and Respiratory Failure)--Cases with 1 7 32,298
procedure code DV10BBZ (Low dose rate (LDR) brachytherapy of
prostate using Palladium[dash]103 (Pd-103))....................
MS-DRG 129 (Major Head and Neck Procedures with CC/MCC or Major 1 3 42,565
Device)--Cases with procedure code DW11BBZ (Low dose rate (LDR)
brachytherapy of head and neck using Palladium[dash]103 (Pd-
103))..........................................................
MS-DRG 330 (Major Small and Large Bowel Procedures with CC)-- 1 8 74,190
Cases with procedure code DW16BBZ (Low dose rate (LDR)
brachytherapy of pelvic region using Palladium[dash]103 (Pd-
103))..........................................................
----------------------------------------------------------------------------------------------------------------
[[Page 41171]]
As shown in the immediately preceding table, we identified 4 cases
reporting one of these LDR brachytherapy procedure codes across all MS-
DRGs, with an average length of stay of 6.3 days and average costs of
$39,853. In the proposed rule, we stated that we believe that creating
a new Pre-MDC MS-DRG based on such a small number of cases could lead
to distortion in the relative payment weights for the Pre-MDC MS-DRG.
Having a larger number of clinically cohesive cases within the Pre-MDC
MS-DRG provides greater stability for annual updates to the relative
payment weights. Therefore, we did not propose to create a new Pre-MDC
MS-DRG for procedures involving the CivaSheet[supreg] technology for FY
2019.
Comment: Some commenters supported CMS' proposal not to create a
new MS-DRG for assignment of procedures involving the CivaSheet[supreg]
technology. Several commenters, including the manufacturer of the
CivaSheet[supreg] technology, disagreed with CMS' proposal, and stated
that the current payment for cases involving the CivaSheet[supreg]
technology is inadequate and does not currently allow widespread
adoption and use of the technology. One commenter noted that its
contractor also identified four cases in the proposed rule, but raised
some concerns regarding the procedure codes and costs associated with
the cases identified in the proposed rule. Other commenters described
the clinical benefits and potential cost-savings associated with the
CivaSheet[supreg] technology, and requested that CMS reconsider its
proposal to not create a new Pre- MDC MS-DRG for the assignment of
cases involving the use of this technology. The commenters stated that
they understood CMS' concern about the lack of volume, but indicated
that the lack of adequate payment for procedures involving the
CivaSheet[supreg] technology does not allow more widespread use. The
manufacturer requested that, if CMS finalizes its proposal not to
create a new MS-DRG for assignment of cases involving the
CivaSheet[supreg] technology, CMS consider other payment mechanisms by
which to ensure adequate payment for hospitals providing this service.
Response: We appreciate the commenters' support and input. With
respect to the commenters who disagreed with our proposal, we reiterate
that our analysis of the claims data and our clinical advisors did not
support the creation of a new MS-DRG based on the very small number of
cases identified. As we noted in the proposed rule, only four cases
were identified. The MS-DRGs are a classification system intended to
group together those diagnoses and procedures with similar clinical
characteristics and utilization of resources. As we discussed in the
proposed rule, basing a new MS-DRG on such a small number of cases
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.
We agree with the commenter that there were some inadvertent errors
in the table included in the proposed rule in reference to certain
procedure codes and MS-DRGs; the table in this final rule above now
correctly reflects the procedure codes and MS-DRGs reflected in the FY
2017 MedPAR file (as of the September 2017 update). We note that
because our proposal was based on the small number of cases, and not
the nature of those cases, these errors had no bearing on our proposal
or our decision to finalize this proposal. We acknowledge the
commenters' concerns about the adequacy of payment for these low volume
services. Therefore, as part of our ongoing, comprehensive analysis of
the MS-DRGs under ICD-10, we will continue to explore mechanisms
through which to address rare diseases and low volume DRGs.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current MS-DRG structure for
procedures involving the CivaSheet[supreg] technology for FY 2019.
c. Laryngectomy
The logic for case assignment to Pre-MDC MS-DRGs 11, 12, and 13
(Tracheostomy for Face, Mouth and Neck Diagnoses with MCC, with CC, and
without CC/MCC, respectively) as displayed in the ICD-10 MS-DRG Version
35 Definitions Manual, which is available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending, is
comprised of a list of procedure codes for laryngectomies, a list of
procedure codes for tracheostomies, and a list of diagnosis codes for
conditions involving the face, mouth, and neck. The procedure codes for
laryngectomies are listed separately and are reported differently from
the procedure codes listed for tracheostomies. The procedure codes
listed for tracheostomies must be reported with a diagnosis code
involving the face, mouth, or neck as a principal diagnosis to satisfy
the logic for assignment to Pre-MDC MS-DRG 11, 12, or 13.
Alternatively, any principal diagnosis code reported with a procedure
code from the list of procedure codes for laryngectomies will satisfy
the logic for assignment to Pre-MDC MS-DRG 11, 12, or 13.
To improve the manner in which the logic for assignment is
displayed in the ICD-10 MS-DRG Definitions Manual and to clarify how it
is applied for grouping purposes, in the FY 2019 IPPS/LTCH PPS proposed
rule (83 FR 20188), we proposed to reorder the lists of the diagnosis
and procedure codes. The list of principal diagnosis codes for face,
mouth, and neck would be sequenced first, followed by the list of the
tracheostomy procedure codes and, lastly, the list of laryngectomy
procedure codes.
We also proposed to revise the titles of Pre-MDC MS-DRGs 11, 12,
and 13 from ``Tracheostomy for Face, Mouth and Neck Diagnoses with MCC,
with CC and without CC/MCC, respectively'' to ``Tracheostomy for Face,
Mouth and Neck Diagnoses or Laryngectomy with MCC'', ``Tracheostomy for
Face, Mouth and Neck Diagnoses or Laryngectomy with CC'', and
``Tracheostomy for Face, Mouth and Neck Diagnoses or Laryngectomy
without CC/MCC'', respectively, to reflect that laryngectomy procedures
may also be assigned to these MS-DRGs.
Comment: Commenters supported CMS' proposal to reorder the lists of
diagnoses and procedure codes for Pre-MDC MS-DRGs 11, 12 and 13 in the
ICD-10 MS-DRG Definitions Manual to clarify the GROUPER logic. The
commenters stated that the proposal was reasonable given the ICD-10-CM
diagnosis codes, the ICD-10-PCS procedure codes, and the information
provided. Commenters also supported the proposal to revise the titles
for Pre-MDC MS-DRGs 11, 12 and 13.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to reorder the lists of diagnoses and procedure
codes for Pre-MDC MS-DRGs 11, 12, and 13 in the ICD-10 MS-DRG
Definitions Manual Version 36. We also are finalizing our proposal to
revise the titles for Pre-MDC MS-DRGs 11, 12, and 13 as follows for the
ICD-10 MS-DRGs Version 36, effective October 1, 2018:
MS-DRG 11 (Tracheostomy for Face, Mouth and Neck Diagnoses
or Laryngectomy with MCC);
[[Page 41172]]
MS-DRG 12 (Tracheostomy for Face, Mouth and Neck Diagnoses
or Laryngectomy with CC); and
MS-DRG 13 (Tracheostomy for Face, Mouth and Neck Diagnoses
or Laryngectomy without CC/MCC).
d. Chimeric Antigen Receptor (CAR) T-Cell Therapy
Chimeric Antigen Receptor (CAR) T-cell therapy is a cell-based gene
therapy in which T-cells are genetically engineered to express a
chimeric antigen receptor that will bind to a certain protein on a
patient's cancerous cells. The CAR T-cells are then administered to the
patient to attack certain cancerous cells and the individual is
observed for potential serious side effects that would require medical
intervention.
Two CAR T-cell therapies received FDA approval in 2017.
KYMRIAH[supreg] (manufactured by Novartis Pharmaceuticals Corporation)
was approved for the use in the treatment of patients up to 25 years of
age with B-cell precursor acute lymphoblastic leukemia (ALL) that is
refractory or in second or later relapse. In May 2018, KYMRIAH received
FDA approval for a second indication, treatment of adult patients with
relapsed or refractory large B-cell lymphoma after two or more lines of
systemic therapy, including diffuse large B-cell lymphoma (DLBCL), high
grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
YESCARTA[supreg] (manufactured by Kite Pharma, Inc.) was approved for
use in the treatment of adult patients with relapsed or refractory
large B-cell lymphoma and who have not responded to or who have
relapsed after at least two other kinds of treatment.
Procedures involving the CAR T-cell therapies are currently
identified with ICD-10-PCS procedure codes XW033C3 (Introduction of
engineered autologous chimeric antigen receptor t-cell immunotherapy
into peripheral vein, percutaneous approach, new technology group 3)
and XW043C3 (Introduction of engineered autologous chimeric antigen
receptor t-cell immunotherapy into central vein, percutaneous approach,
new technology group 3), which both became effective October 1, 2017.
Procedures described by these two ICD-10-PCS procedure codes are
designated as non-O.R. procedures that have no impact on MS-DRG
assignment.
As we discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20189), we have received many inquiries from the public regarding
payment of CAR T-cell therapy under the IPPS. Suggestions for the MS-
DRG assignment for FY 2019 ranged from assigning ICD-10-PCS procedure
codes XW033C3 and XW043C3 to an existing MS-DRG to the creation of a
new MS-DRG for CAR T-cell therapy. In the context of the recommendation
to create a new MS-DRG for FY 2019, we also received suggestions that
payment should be established in a way that promotes comparability
between the inpatient setting and outpatient setting.
As part of our review of these suggestions, we examined the
existing MS-DRGs to identify the MS-DRGs that represent cases most
clinically similar to those cases in which the CAR T-cell therapy
procedures would be reported. The CAR T-cell procedures involve a type
of autologous immunotherapy in which the patient's cells are
genetically transformed and then returned to that patient after the
patient undergoes cell depleting chemotherapy. Our clinical advisors
believe that patients receiving treatment utilizing CAR T-cell therapy
procedures would have similar clinical characteristics and
comorbidities to those seen in cases representing patients receiving
treatment for other hematologic cancers who are treated with autologous
bone marrow transplant therapy that are currently assigned to MS-DRG
016 (Autologous Bone Marrow Transplant with CC/MCC). Therefore, after
consideration of the inquiries received as to how the IPPS can
appropriately group cases reporting the use of CAR T-cell therapy, in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20189), we proposed to
assign ICD-10-PCS procedure codes XW033C3 and XW043C3 to Pre-MDC MS-DRG
016 for FY 2019. In addition, we proposed to revise the title of MS-DRG
016 from ``Autologous Bone Marrow Transplant with CC/MCC'' to
``Autologous Bone Marrow Transplant with CC/MCC or T-cell
Immunotherapy.''
However, we noted in the proposed rule that, as discussed in
greater detail in section II.H.5.a. of the preamble of the proposed
rule and this final rule, the manufacturer of KYMRIAH and the
manufacturer of YESCARTA submitted applications for new technology add-
on payments for FY 2019. We stated that we also recognize that many
members of the public have noted that the combination of the new
technology add-on payment applications, the extremely high-cost of
these CAR T-cell therapies, and the potential for volume increases over
time present unique challenges with respect to the MS-DRG assignment
for procedures involving the utilization of CAR T-cell therapies and
cases representing patients receiving treatment involving CAR T-cell
therapies. We stated in the proposed rule that we believed that, in the
context of these pending new technology add-on payment applications,
there may also be merit in the alternative suggestion we received to
create a new MS-DRG for procedures involving the utilization of CAR T-
cell therapies and cases representing patients receiving treatment
involving CAR T-cell therapy to which we could assign ICD-10-PCS
procedure codes XW033C3 and XW043C3, effective for discharges occurring
in FY 2019. We stated that, as noted in section II.H.5.a. of the
preamble of the proposed rule, if a new MS-DRG were to be created then
consistent with section 1886(d)(5)(K)(ix) of the Act there may no
longer be a need for a new technology add-on payment under section
1886(d)(5)(K)(ii)(III) of the Act.
We invited public comments on our proposed approach of assigning
ICD-10-PCS procedure codes XW033C3 and XW043C3 to Pre-MDC MS-DRG 016
for FY 2019. We also invited public comments on alternative approaches,
including in the context of the pending KYMRIAH and YESCARTA new
technology add-on payment applications, and the most appropriate way to
establish payment for FY 2019 under any alternative approaches. We
indicated that such payment alternatives may include using a CCR of 1.0
for charges associated with ICD-10-PCS procedure codes XW033C3 and
XW043C3, given that many public inquirers believed that hospitals would
be unlikely to set charges different from the costs for KYMRIAH and
YESCARTA CAR T-cell therapies, as discussed further in section
II.A.4.g.2. of the Addendum of the proposed rule and this final rule.
We further stated that these payment alternatives, including payment
under any potential new MS-DRG, also could take into account an
appropriate portion of the average sales price (ASP) for these drugs,
including in the context of the pending new technology add-on payment
applications.
We invited comments on how these payment alternatives would affect
access to care, as well as how they affect incentives to encourage
lower drug prices, which is a high priority for this Administration. In
addition, we stated that we are considering approaches and authorities
to encourage value-based care and lower drug prices. We solicited
comments on how the payment methodology alternatives may intersect and
affect future participation in any such alternative approaches.
We noted that, as stated in section II.F.1.b. of the preamble of
the proposed rule, we described the criteria used to establish new MS-
DRGs. In particular,
[[Page 41173]]
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
whether observed average differences are consistent across patients or
attributable to cases that were 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.
Based on the principles typically used to establish a new MS-DRG, we
solicited comments on how the administration of the CAR T-cell
therapies and associated services meet the criteria for the creation of
a new MS-DRG. Also, section 1886(d)(4)(C)(iii) of the Act specifies
that, beginning in FY 1991, the annual DRG reclassification and
recalibration of the relative weights must be made in a manner that
ensures that aggregate payments to hospitals are not affected. Given
that a new MS-DRG must be established in a budget neutral manner, we
stated that we are concerned with the redistributive effects away from
core hospital services over time toward specialized hospitals and how
that may affect payment for these core services. Therefore, we
solicited public comments on our concerns with the payment alternatives
that we were considering for CAR T-cell therapies.
Comment: Many commenters stated that the existing payment
mechanisms under the IPPS do not allow for accurate payment of CAR T-
cell therapy due its unprecedented high cost. Commenters also asserted
structural insufficiencies in the new technology add-on payments for
the drug therapy, such as the maximum add-on payment of 50 percent; the
inapplicability of the usual cost to charge ratios used in ratesetting
and payment, including those used in determining new technology add-on
payments, outlier payments, and payments to IPPS-excluded cancer
hospitals; and a lack of sufficient historical data and experience
related to a therapy with a cost of this magnitude. In addition,
commenters stated that payment for CAR T-cell therapy should avoid
inappropriate financial incentives for care to be provided in an
outpatient instead of an inpatient setting. Many commenters requested a
permanent and long-term solution to ensure accurate payment for CAR T-
cell therapy while concurrently ensuring any redistributive payment
effects within the IPPS are limited.
Some commenters recommended that, until a more permanent solution
is developed, CMS finalize the proposed assignment of CAR T-cell
therapy to MS-DRG 016, approve the NTAP application for CAR T-cell
therapy, and/or allow for a CCR of 1.0 for CAR T-cell therapy. However,
some commenters disagreed with CMS' proposed assignment of CAR T-cell
therapy to MS-DRG 016 and requested a new separate MS-DRG. These
commenters disagreed that patients receiving CAR T-cell therapy are
sufficiently clinically similar to patients receiving autologous bone
marrow transplants. Reasons cited by these commenters included
differences in lengths of stay, the level and predictability of
associated toxicity, and the overall disease burden. Some of these
commenters suggested creating a new separate MS-DRG for CAR T-cell
therapy and developing the FY 2019 weight for this MS-DRG not based
only on historical claims data but also including alternative data on
the cost of CAR T-cell therapy drugs, such as average sales price (ASP)
data. Some commenters pointed to the establishment of a separate DRG
for drug eluting stents under the IPPS as a possible payment model for
CAR T-cell therapy.
Other commenters did not support the creation of a new separate MS-
DRG for CAR T-cell therapy. Reasons cited by these commenters included
the relative newness of the therapy, the limited number of providers
delivering these treatments, the low volume of patients, redistributive
effects, and the lack of long term data surrounding length of stay,
treatment complexities, and costs. These commenters urged CMS to
collect more comprehensive clinical and cost data before considering
assignment of a new MS-DRG to these therapies.
Some commenters requested that CMS carve out the cost of CAR T-cell
therapy from the IPPS and pay for it on a pass-through basis reflecting
the cost of the therapy to the hospital and indicated that this was the
approach taken by some state Medicaid programs. These commenters
believed that payment on a pass-through basis, for inpatient and/or
outpatient care, provides the most accurate payment while minimizing
inappropriate payment incentives across the inpatient and outpatient
setting.
Commenters also made technical and operational suggestions to CMS
if we were to adopt changes to our existing payment mechanisms in the
final rule as they apply to CAR T-cell therapy, including how a CCR of
1.0 would be operationalized, or how CMS would collect data on the cost
of CAR T-cell therapy for pass-through and other purposes.
Response: Building on President Trump's Blueprint to Lower Drug
Prices and Reduce Out-of-Pocket Costs, the CMS Center for Medicare and
Medicaid Innovation (Innovation Center) is soliciting public comment in
the CY 2019 OPPS/ASC proposed rule on key design considerations for
developing a potential model that would test private market strategies
and introduce competition to improve quality of care for beneficiaries,
while reducing both Medicare expenditures and beneficiaries' out of
pocket spending. CMS sought similar feedback in a previous solicitation
of comments,\4\ and, most recently, in the President's Blueprint to
Lower Drug Prices and Reduce Out-of-Pocket Costs.\5\
---------------------------------------------------------------------------
\4\ CMS included a solicitation of comments on the Competitive
Acquisition Program (CAP) for Part B Drugs and Biologicals (81 FR
13247) in a proposed rule, on March 11, 2016, entitled ``Medicare
Program; Part B Drug Payment Model'' (81 FR 13230). The solicitation
of comments sought to help CMS determine if there was sufficient
interest in the CAP program, and to gather public input if we were
to consider developing and testing a future model that would be at
least partly based on the authority for the CAP under section 1847B
of the Act. The March 11, 2016 proposed rule was withdrawn on
October 4, 2017 (82 FR 46182) to ensure agency flexibility in
reexamining important issues related to the proposed payment model
and exploring new options and alternatives with stakeholders as CMS
develops potential payment models that support innovative approaches
to improve quality, accessibility, and affordability, reduce
Medicare program expenditures, and empower patients and doctors to
make decisions about their health care.
\5\ President Donald J. Trump's Blueprint to Lower Drug Prices
and Reduce Out-of-Pocket Costs, May 11, 2018. Available at: https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-blueprint-lower-drug-prices/.
---------------------------------------------------------------------------
Given the relative newness of CAR T-cell therapy, the potential
model, including the reasons underlying our consideration of a
potential model described in greater detail in the CY 2019 OPPS/ASC
proposed rule, and our request for feedback on this model approach, we
believe it would be premature to adopt changes to our existing payment
mechanisms, either under the IPPS or for IPPS-excluded cancer
hospitals, specifically for CAR T-cell therapy. Therefore, we disagree
with commenters who have requested such changes under the IPPS for FY
[[Page 41174]]
2019, including, but not limited to, the creation of a pass-through
payment; structural changes in new technology add-on payments for the
drug therapy; changes in the usual cost-to-charge ratios (CCRs) used in
ratesetting and payment, including those used in determining new
technology add-on payments, outlier payments, and payments to IPPS
excluded cancer hospitals; and the creation of a new MS-DRG
specifically for CAR T-cell therapy prior to gaining more experience
with the therapy.
We agree with commenters who recommended that we finalize the
proposed assignment of CAR-T therapy to MS-DRG 016 rather than consider
the creation of a new MS-DRG for these therapies, given the relative
newness of the therapy, the limited number of providers delivering
these treatments, the low volume of patients, redistributive effects,
and the lack of long-term data surrounding length of stay, treatment
complexities, and costs. In addition to the potential model, we agree
we should collect more comprehensive clinical and cost data before
considering assignment of a new MS-DRG to these therapies.
In response to the commenters who indicated that MS-DRG 016 is a
poor clinical match for CAR T-cell therapy patients and would prefer
that we create a new MS-DRG for CAR-T cell therapy, we acknowledge that
there are differences between the treatment approaches, but we continue
to believe that MS-DRG 016 is the most appropriate match of the
existing MS-DRGs, given similarities between CAR-T cell therapy and
autologous bone marrow transplant in harvesting and infusion of patient
cells as well as post-infusion monitoring for and management of
potentially severe adverse effects. We reiterate that, in light of the
potential model and our request for feedback on this approach, it would
be premature to create a new MS-DRG specifically for CAR T-cell
therapy. We will consider requests for alternative MS-DRG assignments
and/or the creation of a new MS-DRG for CAR T-cell therapy after we
review the public feedback on a potential model and as we gain further
experience with CAR T-cell therapy and can better evaluate the
commenters' concerns.
As described in more detail in section II.H. of the preamble of
this final rule, we are approving new technology add-on payments for
CAR T-cell therapy for FY 2019.
In response to commenters who made technical and operational
suggestions if CMS were to adopt changes to its existing payment
mechanisms in the final rule as they apply to CAR T-cell therapy,
because we are not adopting such changes, we are not addressing those
technical and operational comments at the current time but will
consider them for future rulemaking as appropriate.
After consideration of the public comments we received, we are
finalizing our proposed approach of assigning ICD-10-PCS procedure
codes XW033C3 and XW043C3 to Pre-MDC MS-DRG 016 for FY 2019 and to
revise the title of MS-DRG 016 from ``Autologous Bone Marrow Transplant
with CC/MCC'' to ``Autologous Bone Marrow Transplant with CC/MCC or T-
cell Immunotherapy.''
3. MDC 1 (Diseases and Disorders of the Nervous System)
a. Epilepsy With Neurostimulator
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38015 through
38019), based on a request we received and our review of the claims
data, the advice of our clinical advisors, and consideration of public
comments, we finalized our proposal to reassign all cases reporting a
principal diagnosis of epilepsy and one of the following ICD-10-PCS
code combinations, which capture cases involving neurostimulator
generators inserted into the skull (including cases involving the use
of the RNS(copyright) neurostimulator), to retitled MS-DRG
023 (Craniotomy with Major Device Implant or Acute Complex Central
Nervous System (CNS) Principal Diagnosis (PDX) with MCC or Chemotherapy
Implant or Epilepsy with Neurostimulator), even if there is no MCC
reported:
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H00MZ (Insertion of
neurostimulator lead into brain, open approach);
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H03MZ (Insertion of
neurostimulator lead into brain, percutaneous approach); and
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H04MZ (Insertion of
neurostimulator lead into brain, percutaneous endoscopic approach).
The finalized listing of epilepsy diagnosis codes (82 FR 38018
through 38019) contained codes provided by the requestor (82 FR 38016),
in addition to diagnosis codes organized in subcategories G40.A- and
G40.B- as recommended by a commenter in response to the proposed rule
(82 FR 38018) because the diagnosis codes organized in these
subcategories also are representative of diagnoses of epilepsy.
For FY 2019, we received a request to include two additional
diagnosis codes organized in subcategory G40.1- in the listing of
epilepsy diagnosis codes for cases assigned to MS-DRG 023 because these
diagnosis codes also represent diagnoses of epilepsy. The two
additional codes identified by the requestor are:
G40.109 (Localization-related (focal) (partial)
symptomatic epilepsy and epileptic syndromes with simple partial
seizures, not intractable, without status epilepticus); and
G40.111 (Localization-related (focal) (partial)
symptomatic epilepsy and epileptic syndromes with simple partial
seizures, intractable, with status epilepticus).
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20190), we stated
that we agreed with the requestor that diagnosis codes G40.109 and
G40.111 also are representative of epilepsy diagnoses and should be
added to the listing of epilepsy diagnosis codes for cases assigned to
MS-DRG 023 because they also capture a type of epilepsy. Our clinical
advisors reviewed this issue and agreed that adding the two additional
epilepsy diagnosis codes is appropriate. Therefore, we proposed to add
ICD-10-CM diagnosis codes G40.109 and G40.111 to the listing of
epilepsy diagnosis codes for cases assigned to MS-DRG 023, effective
October 1, 2018.
Comment: Commenters agreed with CMS' proposal to add ICD-10-CM
diagnosis codes G40.109 and G40.111 to the list of epilepsy diagnosis
codes for assignment to MS-DRG 023. The commenters stated that the
proposal was reasonable, given the ICD-10-CM diagnosis codes and the
information provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add ICD-10-CM diagnosis codes G40.109 and
G40.111 to the list of epilepsy diagnosis codes for assignment to MS-
DRG 023 in the ICD-10 MS-DRGs Version 36, effective October 1, 2018.
b. Neurological Conditions With Mechanical Ventilation
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20190), we received two separate, but related requests to create new
MS-DRGs for cases that identify patients who have been diagnosed with
neurological conditions classified under MDC 1 (Diseases and Disorders
of the Nervous
[[Page 41175]]
System) and who require mechanical ventilation with and without a
thrombolytic and in the absence of an O.R. procedure. The requestors
suggested that CMS consider when mechanical ventilation is reported
with a neurological condition for the ICD-10 MS-DRG GROUPER assignment
logic, similar to the current logic for MS-DRGs 207 and 208
(Respiratory System Diagnosis with Ventilator Support >96 Hours and
<=96 Hours, respectively) under MDC 4 (Diseases and Disorders of the
Respiratory System), which consider respiratory conditions that require
mechanical ventilation and are assigned a higher relative weight.
The requestors stated that patients with a principal diagnosis of
respiratory failure requiring mechanical ventilation are currently
assigned to MS-DRG 207 (Respiratory System Diagnoses with Ventilator
Support >96 Hours), which has a relative weight of 5.4845, and to MS-
DRG 208 (Respiratory System Diagnoses with Ventilator Support <=96
Hours), which has a relative weight of 2.3678. The requestors also
stated that patients with a principal diagnosis of ischemic cerebral
infarction who received a thrombolytic agent during the hospital stay
and did not undergo an O.R. procedure are assigned to MS-DRGs 061, 062,
and 063 (Ischemic Stroke, Precerebral Occlusion or Transient Ischemia
with Thrombolytic Agent with MCC, with CC, and without CC/MCC,
respectively) under MDC 1, while patients with a principal diagnosis of
intracranial hemorrhage or ischemic cerebral infarction who did not
receive a thrombolytic agent during the hospital stay and did not
undergo an O.R. procedure are assigned to MS-DRGs 064, 065 and 66
(Intracranial Hemorrhage or Cerebral Infarction with MCC, with CC or
TPA in 24 Hours, and without CC/MCC, respectively) under MDC 1.
The requestors provided the current FY 2018 relative weights for
these MS-DRGs as shown in the following table.
------------------------------------------------------------------------
Relative
MS-DRG MS-DRG title weight
------------------------------------------------------------------------
MS-DRG 061.................. Ischemic Stroke, 2.7979
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent with
MCC.
MS-DRG 062.................. Ischemic Stroke, l.9321
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent with
CC.
MS-DRG 063.................. Ischemic Stroke, l.6169
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent
without CC/MCC.
MS-DRG 064.................. Intracranial Hemorrhage or l.7685
Cerebral Infarction with
MCC.
MS-DRG 065.................. Intracranial Hemorrhage or 1.0311
Cerebral Infarction with
CC or TPA in 24 hours.
MS-DRG 066.................. Intracranial Hemorrhage or .7466
Cerebral Infarction with
MCC.
------------------------------------------------------------------------
The requestors stated that although the ICD-10-CM Official
Guidelines for Coding and Reporting allow sequencing of acute
respiratory failure as the principal diagnosis when it is jointly
responsible (with an acute neurologic event) for admission, which would
result in assignment to MS-DRGs 207 or 208 when the patient requires
mechanical ventilation, it would not be appropriate to sequence acute
respiratory failure as the principal diagnosis when it is secondary to
intracranial hemorrhage or ischemic cerebral infarction.
The requestors also stated that reporting for other purposes, such
as quality measures, clinical trials, and Joint Commission and State
certification or survey cases, is based on the principal diagnosis, and
it is important, from a quality of care perspective, that the
intracranial hemorrhage or cerebral infarction codes continue to be
sequenced as principal diagnosis. The requestors believed that cases of
patients who present with cerebral infarction or cerebral hemorrhage
and acute respiratory failure are currently in conflict for principal
diagnosis sequencing because the cerebral infarction or cerebral
hemorrhage code is needed as the principal diagnosis for quality
reporting and other purposes. However, acute respiratory failure is
needed as the principal diagnosis for purposes of appropriate payment
under the MS-DRGs.
The requestors stated that by creating new MS-DRGs for neurological
conditions with mechanical ventilation, those patients who require
mechanical ventilation for airway protection on admission and those
patients who develop acute respiratory failure requiring mechanical
ventilation after admission can be grouped to MS-DRGs that provide
appropriate payment for the mechanical ventilation resources. The
requestors suggested two new MS-DRGs, citing as support that new MS-
DRGs were created for patients with sepsis requiring mechanical
ventilation greater than and less than 96 hours.
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20191) and earlier in this section, the requests we received were
separate, but related requests. The first request was to specifically
identify patients presenting with intracranial hemorrhage or cerebral
infarction with mechanical ventilation and create two new MS-DRGs as
follows:
Suggested new MS-DRG XXX (Intracranial Hemorrhage or
Cerebral Infarction with Mechanical Ventilation >96 Hours); and
Suggested new MS-DRG XXX (Intracranial Hemorrhage or
Cerebral Infarction with Mechanical Ventilation <=96 Hours).
The second request was to consider any principal diagnosis under
the current GROUPER logic for MDC 1 with mechanical ventilation and
create two new MS-DRGs as follows:
Suggested New MS-DRG XXX (Neurological System Diagnosis
with Mechanical Ventilation 96+ Hours); and
Suggested New MS-DRG XXX (Neurological System Diagnosis
with Mechanical Ventilation <96 Hours).
Both requesters suggested that CMS use the three ICD-10-PCS codes
identifying mechanical ventilation to assign cases to the respective
suggested new MS-DRGs. The three ICD-10-PCS codes are shown in the
following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
5A1935Z............................. Respiratory ventilation, less than
96 consecutive hours.
5A1945Z............................. Respiratory ventilation, 24-96
consecutive hours.
5A1955Z............................. Respiratory ventilation, greater
than 96 consecutive hours.
------------------------------------------------------------------------
[[Page 41176]]
Below we discuss the different aspects of each request in more
detail.
The first request involved two aspects: (1) Analyzing patients
diagnosed with cerebral infarction and required mechanical ventilation
who received a thrombolytic (for example, TPA) and did not undergo an
O.R. procedure; and (2) analyzing patients diagnosed with intracranial
hemorrhage or ischemic cerebral infarction and required mechanical
ventilation who did not receive a thrombolytic (for example, TPA)
during the current episode of care and did not undergo an O.R.
procedure.
For the first subset of patients, we analyzed claims data from the
September 2017 update of the FY 2017 MedPAR file for MS-DRGs 061, 062,
and 063 because cases that are assigned to these MS-DRGs specifically
identify patients who were diagnosed with a cerebral infarction and
received a thrombolytic. The 90 ICD-10-CM diagnosis codes that specify
a cerebral infarction and were included in our analysis are listed in
Table 6P.1a associated with the proposed rule (which is available via
the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
The ICD-10-PCS procedure codes displayed in the following table
describe use of a thrombolytic agent.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
3E03017............................. Introduction of other thrombolytic
into peripheral vein, open
approach.
3E03317............................. Introduction of other thrombolytic
into peripheral vein,
percutaneous approach.
3E04017............................. Introduction of other thrombolytic
into central vein, open approach.
3E04317............................. Introduction of other thrombolytic
into central vein, percutaneous
approach.
3E05017............................. Introduction of other thrombolytic
into peripheral artery, open
approach.
3E05317............................. Introduction of other thrombolytic
into peripheral artery,
percutaneous approach.
3E06017............................. Introduction of other thrombolytic
into central artery, open
approach.
3E06317............................. Introduction of other thrombolytic
into central artery, percutaneous
approach.
3E08017............................. Introduction of other thrombolytic
into heart, open approach.
3E08317............................. Introduction of other thrombolytic
into heart, percutaneous
approach.
------------------------------------------------------------------------
We examined claims data in MS-DRGs 061, 062, and 063 and identified
cases that reported mechanical ventilation of any duration with a
principal diagnosis of cerebral infarction where a thrombolytic agent
was administered and the patient did not undergo an O.R. procedure. Our
findings are shown in the following table.
Cerebral Infarction With Thrombolytic and MV
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 061--All cases........................................... 5,192 6.4 $20,097
MS-DRG 061--Cases with principal diagnosis of cerebral 166 12.8 41,691
infarction and mechanical ventilation >96 hours................
MS-DRG 061--Cases with principal diagnosis of cerebral 378 7.5 26,368
infarction and mechanical ventilation = 24-96 hours............
MS-DRG 061--Cases with principal diagnosis of cerebral 214 4.9 19,795
infarction and mechanical ventilation <24 hours................
MS-DRG 062--All cases........................................... 9,730 3.9 13,865
MS-DRG 062--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 062--Cases with principal diagnosis of cerebral 10 5.3 19,817
infarction and mechanical ventilation = 24-96 hours............
MS-DRG 062--Cases with principal diagnosis of cerebral 23 3.8 14,026
infarction and mechanical ventilation <24 hours................
MS-DRG 063--All cases........................................... 1,984 2.7 11,771
MS-DRG 063--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 063--Cases with principal diagnosis of cerebral 3 2.7 14,588
infarction and mechanical ventilation = 24-96 hours............
MS-DRG 063--Cases with principal diagnosis of cerebral 5 2.0 11,195
infarction and mechanical ventilation <24 hours................
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 5,192 cases in MS-DRG
061 with an average length of stay of 6.4 days and average costs of
$20,097. There were a total of 758 cases reporting the use of
mechanical ventilation in MS-DRG 061 with an average length of stay
ranging from 4.9 days to 12.8 days and average costs ranging from
$19,795 to $41,691. For MS-DRG 062, there were a total of 9,730 cases
with an average length of stay of 3.9 days and average costs of
$13,865. There were a total of 33 cases reporting the use of mechanical
ventilation in MS-DRG 062 with an average length of stay ranging from
3.8 days to 5.3 days and average costs ranging from $14,026 to $19,817.
For MS-DRG 063, there were a total of 1,984 cases with an average
length of stay of 2.7 days and average costs of $11,771. There were a
total of 8 cases reporting the use of mechanical ventilation in MS-DRG
063 with an average length of stay ranging from 2.0 days to 2.7 days
and average costs ranging from $11,195 to $14,588.
We then compared the total number of cases in MS-DRGs 061, 062, and
063 specifically reporting mechanical
[[Page 41177]]
ventilation >96 hours with a principal diagnosis of cerebral infarction
where a thrombolytic agent was administered and the patient did not
undergo an O.R. procedure against the total number of cases reporting
mechanical ventilation <=96 hours with a principal diagnosis of
cerebral infarction where a thrombolytic agent was administered and the
patient did not undergo an O.R. procedure. Our findings are shown in
the following table.
Cerebral Infarction With Thrombolytic and MV
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 061--All cases........................................... 5,192 6.4 $20,097
MS-DRG 061--Cases with principal diagnosis of cerebral 166 12.8 41,691
infarction and mechanical ventilation >96 hours................
MS-DRG 061--Cases with principal diagnosis of cerebral 594 6.5 23,780
infarction and mechanical ventilation <=96 hours...............
MS-DRG 062--All cases........................................... 9,730 3.9 13,865
MS-DRG 062--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 062--Cases with principal diagnosis of cerebral 34 4.2 15,558
infarction and mechanical ventilation <=96 hours...............
MS-DRG 063--All cases........................................... 1,984 2.7 11,771
MS-DRG 063--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 063--Cases with principal diagnosis of cerebral 8 2.3 12,467
infarction and mechanical ventilation <=96 hours...............
----------------------------------------------------------------------------------------------------------------
As shown in this table, the total number of cases reported in MS-
DRG 061 was 5,192, with an average length of stay of 6.4 days and
average costs of $20,097. There were 166 cases that reported mechanical
ventilation >96 hours, with an average length of stay of 12.8 days and
average costs of $41,691. There were 594 cases that reported mechanical
ventilation <=96 hours, with an average length of stay of 6.5 days and
average costs of $23,780.
The total number of cases reported in MS-DRG 062 was 9,730, with an
average length of stay of 3.9 days and average costs of $13,865. There
were no cases identified in MS-DRG 062 where mechanical ventilation >96
hours was reported. However, there were 34 cases that reported
mechanical ventilation <=96 hours, with an average length of stay of
4.2 days and average costs of $15,558.
The total number of cases reported in MS-DRG 63 was 1,984 with an
average length of stay of 2.7 days and average costs of $11,771. There
were no cases identified in MS-DRG 063 where mechanical ventilation >96
hours was reported. However, there were 8 cases that reported
mechanical ventilation <=96 hours, with an average length of stay of
2.3 days and average costs of $12,467.
For the second subset of patients, we examined claims data for MS-
DRGs 064, 065, and 066. We identified cases reporting mechanical
ventilation of any duration with a principal diagnosis of cerebral
infarction or intracranial hemorrhage where a thrombolytic agent was
not administered during the current hospital stay and the patient did
not undergo an O.R. procedure. The 33 ICD-10-CM diagnosis codes that
specify an intracranial hemorrhage and were included in our analysis
are listed in Table 6P.1b associated with the proposed rule (which is
available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
We also used the list of 90 ICD-10-CM diagnosis codes that specify
a cerebral infarction listed in Table 6P.1a associated with the
proposed rule for our analysis. We noted that the GROUPER logic for
case assignment to MS-DRG 065 includes that a thrombolytic agent (for
example, TPA) was administered within 24 hours of the current hospital
stay. The ICD-10-CM diagnosis code that describes this scenario is
Z92.82 (Status post administration of tPA (rtPA) in a different
facility within the last 24 hours prior to admission to current
facility). We did not review the cases reporting that diagnosis code
for our analysis. Our findings are shown in the following table.
Cerebral Infarction or Intracranial Hemorrhage With MV and Without Thrombolytic
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 064--All cases........................................... 76,513 6.0 $12,574
MS-DRG 064--Cases with principal diagnosis of cerebral 2,153 13.4 38,262
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 064--Cases with principal diagnosis of cerebral 4,843 6.6 18,119
infarction or intracranial hemorrhage and mechanical
ventilation = 24-96 hours......................................
MS-DRG 064--Cases with principal diagnosis of cerebral 4,001 3.1 8,675
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
MS-DRG 065--All cases........................................... 106,554 3.7 7,236
MS-DRG 065--Cases with principal diagnosis of cerebral 22 10.2 20,759
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 065--Cases with principal diagnosis of cerebral 127 4.2 12,688
infarction or intracranial hemorrhage and mechanical
ventilation = 24-96 hours......................................
MS-DRG 065--Cases with principal diagnosis of cerebral 301 2.1 6,145
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
[[Page 41178]]
MS-DRG 066--All cases........................................... 34,689 2.5 5,321
MS-DRG 066--Cases with principal diagnosis of cerebral 1 4.0 3,426
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 066--Cases with principal diagnosis of cerebral 31 3.7 10,364
infarction or intracranial hemorrhage and mechanical
ventilation = 24-96 hours......................................
MS-DRG 066--Cases with principal diagnosis of cerebral 163 1.4 4,148
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
----------------------------------------------------------------------------------------------------------------
The total number of cases reported in MS-DRG 064 was 76,513, with
an average length of stay of 6.0 days and average costs of $12,574.
There were a total of 10,997 cases reporting the use of mechanical
ventilation in MS-DRG 064 with an average length of stay ranging from
3.1 days to 13.4 days and average costs ranging from $8,675 to $38,262.
For MS-DRG 065, there were a total of 106,554 cases with an average
length of stay of 3.7 days and average costs of $7,236. There were a
total of 450 cases reporting the use of mechanical ventilation in MS-
DRG 065 with an average length of stay ranging from 2.1 days to 10.2
days and average costs ranging from $6,145 to $20,759. For MS-DRG 066,
there were a total of 34,689 cases with an average length of stay of
2.5 days and average costs of $5,321. There were a total of 195 cases
reporting the use of mechanical ventilation in MS-DRG 066 with an
average length of stay ranging from 1.4 days to 4.0 days and average
costs ranging from $3,426 to $10,364.
We then compared the total number of cases in MS-DRGs 064, 065, and
066 specifically reporting mechanical ventilation >96 hours with a
principal diagnosis of cerebral infarction or intracranial hemorrhage
where a thrombolytic agent was not administered and the patient did not
undergo an O.R. procedure against the total number of cases reporting
mechanical ventilation <=96 hours with a principal diagnosis of
cerebral infarction or intracranial hemorrhage where a thrombolytic
agent was not administered and the patient did not undergo an O.R.
procedure. Our findings are shown in the following table.
Cerebral Infarction or Intracranial Hemorrhage With MV and Without Thrombolytic
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 064--All cases........................................... 76,513 6.0 $12,574
MS-DRG 064--Cases with principal diagnosis of cerebral 2,153 13.4 38,262
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 064--Cases with principal diagnosis of cerebral 8,794 4.9 13,704
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
MS-DRG 065--All cases........................................... 106,554 3.7 7,236
MS-DRG 065--Cases with principal diagnosis of cerebral 22 10.2 20,759
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 065--Cases with principal diagnosis of cerebral 428 2.7 8,086
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
MS-DRG 066--All cases........................................... 34,689 2.5 5,321
MS-DRG 066--Cases with principal diagnosis of cerebral 1 4.0 3,426
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 066--Cases with principal diagnosis of cerebral 194 1.8 5,141
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
----------------------------------------------------------------------------------------------------------------
The total number of cases reported in MS-DRG 064 was 76,513, with
an average length of stay of 6.0 days and average costs of $12,574.
There were 2,153 cases that reported mechanical ventilation >96 hours,
with an average length of stay of 13.4 days and average costs of
$38,262, and there were 8,794 cases that reported mechanical
ventilation <=96 hours, with an average length of stay of 4.9 days and
average costs of $13,704.
The total number of cases reported in MS-DRG 65 was 106,554, with
an average length of stay of 3.7 days and average costs of $7,236.
There were 22 cases that reported mechanical ventilation >96 hours,
with an average length of stay of 10.2 days and average costs of
$20,759, and there were 428 cases that reported mechanical ventilation
<=96 hours, with an average length of stay of 2.7 days and average
costs of $8,086.
The total number of cases reported in MS-DRG 66 was 34,689, with an
average length of stay of 2.5 days and average costs of $5,321. There
was one case that reported mechanical ventilation >96 hours, with an
average length of stay of 4.0 days and average costs of $3,426, and
there were 194 cases that reported mechanical ventilation <=96 hours,
with an average length of stay of 1.8 days and average costs of $5,141.
We also analyzed claims data for MS-DRGs 207 and 208. As shown in
the following table, there were a total of 19,471 cases found in MS-DRG
207 with an average length of stay of 13.8 days and average costs of
$38,124. For MS-DRG 208, there were a total of 55,802 cases found with
an average length of stay of 6.7 days and average costs of $17,439.
[[Page 41179]]
Respiratory System Diagnosis With Ventilator Support
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 207--All cases........................................... 19,471 13.8 $38,124
MS-DRG 208--All cases........................................... 55,802 6.7 17,439
----------------------------------------------------------------------------------------------------------------
We stated in the proposed rule that our analysis of claims data
relating to the first request for MS-DRGs 061, 062, 063, 064, 065, and
066 and consultation with our clinical advisors do not support creating
new MS-DRGs for cases that identify patients diagnosed with cerebral
infarction or intracranial hemorrhage who require mechanical
ventilation with or without a thrombolytic and in the absence of an
O.R. procedure.
For the first subset of patients (in MS-DRGs 061, 062 and 063), our
data findings for MS-DRG 061 demonstrate the 166 cases that reported
mechanical ventilation >96 hours had a longer average length of stay
(12.8 days versus 6.4 days) and higher average costs ($41,691 versus
$20,097) compared to all the cases in MS-DRG 061. However, there were
no cases that reported mechanical ventilation >96 hours for MS-DRG 062
or MS-DRG 063. For the 594 cases that reported mechanical ventilation
<=96 hours in MS-DRG 061, the data show that the average length of stay
was consistent with the average length of stay of all of the cases in
MS-DRG 061 (6.5 days versus 6.4 days) and the average costs were also
consistent with the average costs of all of the cases in MS-DRG 061
($23,780 versus $20,097). For the 34 cases that reported mechanical
ventilation <=996 hours in MS-DRG 062, the data show that the average
length of stay was consistent with the average length of stay of all of
the cases in MS-DRG 062 (4.2 days versus 3.9 days) and the average
costs were also consistent with the average costs of all of the cases
in MS DRG 062 ($15,558 versus $13,865). Lastly, for the 8 cases that
reported mechanical ventilation <=96 hours in MS-DRG 063, the data show
that the average length of stay was consistent with the average length
of stay of all of the cases in MS-DRG 063 (2.3 days versus 2.7 days)
and the average costs were also consistent with the average costs of
all of the cases in MS DRG 063 ($12,467 versus $11,771).
For the second subset of patients (in MS-DRGs 064, 065 and 066),
the data findings for the 2,153 cases that reported mechanical
ventilation >96 hours in MS-DRG 064 showed a longer average length of
stay (13.4 days versus 6.0 days) and higher average costs ($38,262
versus $12,574) compared to all of the cases in MS-DRG 064. However,
the 2,153 cases represent only 2.8 percent of all the cases in MS-DRG
064. For the 22 cases that reported mechanical ventilation >96 hours in
MS-DRG 065, the data showed a longer average length of stay (10.2 days
versus 3.7 days) and higher average costs ($20,759 versus $7,236)
compared to all of the cases in MS-DRG 065. However, the 22 cases
represent only 0.02 percent of all the cases in MS-DRG 065. For the one
case that reported mechanical ventilation >96 hours in MS-DRG 066, the
data showed a longer average length of stay (4.0 days versus 2.5 days)
and lower average costs ($3,426 versus $5,321) compared to all of the
cases in MS-DRG 066. For the 8,794 cases that reported mechanical
ventilation <=96 hours in MS-DRG 064, the data showed that the average
length of stay was shorter than the average length of stay for all of
the cases in MS-DRG 064 (4.9 days versus 6.0 days) and the average
costs were consistent with the average costs of all of the cases in MS-
DRG 064 ($13,704 versus $12,574). For the 428 cases that reported
mechanical ventilation <=96 hours in MS-DRG 065, the data showed that
the average length of stay was shorter than the average length of stay
for all of the cases in MS-DRG 065 (2.7 days versus 3.7 days) and the
average costs were consistent with the average costs of all the cases
in MS-DRG 065 ($8,086 versus $7,236). For the 194 cases that reported
mechanical ventilation <=96 hours in MS-DRG 066, the data showed that
the average length of stay was shorter than the average length of stay
for all of the cases in MS-DRG 066 (1.8 days versus 2.5 days) and the
average costs were less than the average costs of all of the cases in
MS-DRG 066 ($5,141 versus $5,321).
We stated in the proposed rule that, based on the analysis
described above, the current MS-DRG assignment for the cases in MS-DRGs
061, 062, 063, 064, 065 and 066 that identify patients diagnosed with
cerebral infarction or intracranial hemorrhage who require mechanical
ventilation with or without a thrombolytic and in the absence of an
O.R. procedure appears appropriate.
Our clinical advisors also noted that patients requiring mechanical
ventilation (in the absence of an O.R. procedure) are known to be more
resource intensive and it would not be practical to create new MS-DRGs
specifically for this subset of patients diagnosed with an acute
neurologic event, given the various indications for which mechanical
ventilation may be utilized. We stated in the proposed rule that, if we
were to create new MS-DRGs for patients diagnosed with an intracranial
hemorrhage or cerebral infarction who require mechanical ventilation,
it would not address all of the other patients who also utilize
mechanical ventilation resources. It would also necessitate further
extensive analysis and evaluation for several other conditions that
require mechanical ventilation across each of the 25 MDCs under the
ICD-10 MS-DRGs.
To evaluate the frequency in which the use of mechanical
ventilation is reported for different clinical scenarios, we examined
claims data across each of the 25 MDCs to determine the number of cases
reporting the use of mechanical ventilation >96 hours. Our findings are
shown in the table below.
Mechanical Ventilation >96 Hours Across All MDCs
----------------------------------------------------------------------------------------------------------------
Number of Average length
MDC cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with mechanical ventilation >96 hours................. 127,626 18.4 $61,056
MDC 1 (Diseases and Disorders of the Nervous System)--Cases with 13,668 18.3 61,234
mechanical ventilation >96 hours...............................
MDC 2 (Disease and Disorders of the Eye)--Cases with mechanical 33 22.7 79,080
ventilation >96 hours..........................................
[[Page 41180]]
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and 602 20.3 62,625
Throat)--Cases with mechanical ventilation >96 hours...........
MDC 4 (Diseases and Disorders of the Respiratory System)--Cases 27,793 16.6 48,869
with mechanical ventilation >96 hours..........................
MDC 5 (Diseases and Disorders of the Circulatory System)--Cases 16,923 20.7 84,565
with mechanical ventilation >96 hours..........................
MDC 6 (Diseases and Disorders of the Digestive System)--Cases 6,401 22.4 73,759
with mechanical ventilation >96 hours..........................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and 1,803 24.5 80,477
Pancreas)--Cases with mechanical ventilation >96 hours.........
MDC 8 (Diseases and Disorders of the Musculoskeletal System and 2,780 22.3 83,271
Connective Tissue)--Cases with mechanical ventilation >96 hours
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue 390 22.2 68,288
and Breast)--Cases with mechanical ventilation >96 hours.......
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and 1,168 20.9 60,682
Disorders)--Cases with mechanical ventilation >96 hours........
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)-- 2,325 19.6 57,893
Cases with mechanical ventilation >96 hours....................
MDC 12 (Diseases and Disorders of the Male Reproductive System)-- 54 26.8 95,204
Cases with mechanical ventilation >96 hours....................
MDC 13 (Diseases and Disorders of the Female Reproductive 89 24.6 83,319
System)--Cases with mechanical ventilation >96 hours...........
MDC 14 (Pregnancy, Childbirth and the Puerperium)--Cases with 22 17.4 56,981
mechanical ventilation >96 hours...............................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, 468 20.1 68,658
Immunologic Disorders)--Cases with mechanical ventilation >96
hours..........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly 538 29.7 99,968
Differentiated Neoplasms)--Cases with mechanical ventilation
>96 hours......................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or 48,176 17.3 55,022
Unspecified Sites)--Cases with mechanical ventilation >96 hours
MDC 19 (Mental Diseases and Disorders)--Cases with mechanical 54 29.3 52,749
ventilation >96 hours..........................................
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental 312 20.5 47,637
Disorders)--Cases with mechanical ventilation >96 hours........
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)--Cases 2,436 18.2 57,712
with mechanical ventilation >96 hours..........................
MDC 22 (Burns)--Cases with mechanical ventilation >96 hours..... 242 34.8 188,704
MDC 23 (Factors Influencing Health Status and Other Contacts 64 17.7 50,821
with Health Services)--Cases with mechanical ventilation >96
hours..........................................................
MDC 24 (Multiple Significant Trauma)--Cases with mechanical 922 17.6 72,358
ventilation >96 hours..........................................
MDC 25 (Human Immunodeficiency Virus Infections)--Cases with 363 19.1 56,688
mechanical ventilation >96 hours...............................
----------------------------------------------------------------------------------------------------------------
As shown in the table, the top 5 MDCs with the largest number of
cases reporting mechanical ventilation >96 hours are MDC 18, with
48,176 cases; MDC 4, with 27,793 cases; MDC 5, with 16,923 cases; MDC
1, with 13,668 cases; and MDC 6, with 6,401 cases. We noted that the
claims data demonstrate that the average length of stay is consistent
with what we would expect for cases reporting the use of mechanical
ventilation >96 hours across each of the 25 MDCs. The top 5 MDCs with
the highest average costs for cases reporting mechanical ventilation
>96 hours were MDC 22, with average costs of $188,704; MDC 17, with
average costs of $99,968; MDC 12, with average costs of $95,204; MDC 5,
with average costs of $84,565; and MDC 13, with average costs of
$83,319. We noted that the data for MDC 8 demonstrated similar results
compared to MDC 13 with average costs of $83,271 for cases reporting
mechanical ventilation >96 hours. In summary, the claims data reflect a
wide variance with regard to the frequency and average costs for cases
reporting the use of mechanical ventilation >96 hours.
We also examined claims data across each of the 25 MDCs for the
number of cases reporting the use of mechanical ventilation <=96 hours.
Our findings are shown in the table below.
Mechanical Ventilation <=96 Hours Across All MDCs
----------------------------------------------------------------------------------------------------------------
Number of Average length
MDC cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with mechanical ventilation <=96 hours................ 266,583 8.5 $26,668
MDC 1 (Diseases and Disorders of the Nervous System)--Cases with 29,896 7.4 22,838
mechanical ventilation <=96 hours..............................
MDC 2 (Disease and Disorders of the Eye)--Cases with mechanical 60 8.4 29,708
ventilation <=96 hours.........................................
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and 1,397 9.8 29,479
Throat)--Cases with mechanical ventilation <=96 hours..........
MDC 4 (Diseases and Disorders of the Respiratory System)--Cases 64,861 7.8 20,929
with mechanical ventilation <=96 hours.........................
[[Page 41181]]
MDC 5 (Diseases and Disorders of the Circulatory System)--Cases 45,147 8.8 35,818
with mechanical ventilation <=96 hours.........................
MDC 6 (Diseases and Disorders of the Digestive System)--Cases 15,629 11.3 33,660
with mechanical ventilation <=96 hours.........................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and 4,678 10.5 31,565
Pancreas)--Cases with mechanical ventilation <=96 hours........
MDC 8 (Diseases and Disorders of the Musculoskeletal System and 7,140 10.4 40,183
Connective Tissue)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue 1,036 10.7 26,809
and Breast)--Cases with mechanical ventilation <=96 hours......
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and 3,591 9.0 23,863
Disorders)--Cases with mechanical ventilation <=96 hours.......
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)-- 5,506 10.2 27,951
Cases with mechanical ventilation <=96 hours...................
MDC 12 (Diseases and Disorders of the Male Reproductive System)-- 168 11.5 35,009
Cases with mechanical ventilation <=96 hours...................
MDC 13 (Diseases and Disorders of the Female Reproductive 310 10.8 32,382
System)--Cases with mechanical ventilation <=96 hours..........
MDC 14 (Pregnancy, Childbirth and the Puerperium)--Cases with 55 7.6 21,785
mechanical ventilation <=96 hours..............................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, 1,171 8.7 26,138
Immunologic Disorders)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly 1,178 15.3 46,335
Differentiated Neoplasms)--Cases with mechanical ventilation
<=96 hours.....................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or 69,826 8.5 25,253
Unspecified Sites)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 19 (Mental Diseases and Disorders)--Cases with mechanical 264 10.4 18,805
ventilation <=96 hours.........................................
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental 918 8.3 19,376
Disorders)--Cases with mechanical ventilation <=96 hours.......
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)--Cases 10,842 6.5 17,843
with mechanical ventilation <=96 hours.........................
MDC 22 (Burns)--Cases with mechanical ventilation <=96 hours.... 353 9.7 45,557
MDC 23 (Factors Influencing Health Status and Other Contacts 307 6.6 16,159
with Health Services)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 24 (Multiple Significant Trauma)--Cases with mechanical 1,709 8.8 36,475
ventilation <=96 hours.........................................
MDC 25 (Human Immunodeficiency Virus Infections)--Cases with 541 10.4 29,255
mechanical ventilation <=96 hours..............................
----------------------------------------------------------------------------------------------------------------
As shown in the table, the top 5 MDCs with the largest number of
cases reporting mechanical ventilation <=96 hours are MDC 18, with
69,826 cases; MDC 4, with 64,861 cases; MDC 5, with 45,147 cases; MDC
1, with 29,896 cases; and MDC 6, with 15,629 cases. We noted that the
claims data demonstrate that the average length of stay is consistent
with what we would expect for cases reporting the use of mechanical
ventilation <=96 hours across each of the 25 MDCs. The top 5 MDCs with
the highest average costs for cases reporting mechanical ventilation
<=96 hours are MDC 17, with average costs of $46,335; MDC 22, with
average costs of $45,557; MDC 8, with average costs of $40,183; MDC 24,
with average costs of $36,475; and MDC 5, with average costs of
$35,818. Similar to the cases reporting mechanical ventilation >96
hours, the claims data for cases reporting the use of mechanical
ventilation <=96 hours also reflect a wide variance with regard to the
frequency and average costs. Depending on the number of cases in each
MS-DRG, it may be difficult to detect patterns of complexity and
resource intensity.
With respect to the requestor's statement that reporting for other
purposes, such as quality measures, clinical trials, and Joint
Commission and State certification or survey cases, is based on the
principal diagnosis, and their belief that patients who present with
cerebral infarction or cerebral hemorrhage and acute respiratory
failure are currently in conflict for principal diagnosis sequencing
because the cerebral infarction or cerebral hemorrhage code is needed
as the principal diagnosis for quality reporting and other purposes
(however, acute respiratory failure is needed as the principal
diagnosis for purposes of appropriate payment under the MS-DRGs), we
noted that providers are required to assign the principal diagnosis
according to the ICD-10-CM Official Guidelines for Coding and Reporting
and these assignments are not based on factors such as quality measures
or clinical trials indications. Furthermore, we do not base MS-DRG
reclassification decisions on those factors. If the cerebral hemorrhage
or ischemic cerebral infarction is the reason for admission to the
hospital, the cerebral hemorrhage or ischemic cerebral infarction
diagnosis code should be assigned as the principal diagnosis.
We acknowledged in the proposed rule that new MS-DRGs were created
for cases of patients with sepsis requiring mechanical ventilation
greater than and less than 96 hours. However, those MS-DRGs (MS-DRG 575
(Septicemia with Mechanical Ventilation 96+ Hours Age >17) and MS-DRG
576 (Septicemia without Mechanical Ventilation 96+ Hours Age >17)) were
created several years ago, in FY 2007 (71 FR 47938 through 47939) in
response to public comments suggesting alternatives for the need to
recognize the treatment for that subset of patients with severe sepsis
who exhibit a greater degree of severity and resource consumption as
septicemia is a systemic condition, and also as a
[[Page 41182]]
preliminary step in the transition from the CMS DRGs to MS-DRGs.
We stated in the proposed rule that we believe that additional
analysis and efforts toward a broader approach to refining the MS-DRGs
for cases of patients requiring mechanical ventilation across the MDCs
involves carefully examining the potential for instability in the
relative weights and disrupting the integrity of the MS-DRG system
based on the creation of separate MS-DRGs involving small numbers of
cases for various indications in which mechanical ventilation may be
required.
The second request focused on patients diagnosed with any
neurological condition classified under MDC 1 requiring mechanical
ventilation in the absence of an O.R. procedure and without having
received a thrombolytic agent. Because the first request specifically
involved analysis for the acute neurological conditions of cerebral
infarction and intracranial hemorrhage under MDC 1 and our findings did
not support creating new MS-DRGs for those specific conditions, we did
not perform separate claims analysis for other conditions classified
under MDC 1.
Therefore, in the FY 2019 IPPS/LTCH PPS proposed rule, we did not
propose to create new MS-DRGs for cases that identify patients
diagnosed with neurological conditions classified under MDC 1 who
require mechanical ventilation with or without a thrombolytic and in
the absence of an O.R. procedure.
Comment: Commenters supported CMS' proposal to not create new MS-
DRGs, classified under MDC 1, for cases representing patients diagnosed
with a neurological condition who require mechanical ventilation with
or without a thrombolytic, and in the absence of an O.R. procedure. The
commenters stated that the proposal was reasonable, given the data, the
ICD-10-CM diagnosis codes, the ICD-10-PCS procedure codes, and the
information provided. However, the commenters also recommended that CMS
continue to conduct further analyses across all the MDCs for the subset
of patients who require mechanical ventilation in an effort to better
address the reporting and payment issues.
Response: We appreciate the commenters' support and agree that
further analyses are necessary to evaluate the development of potential
proposals for the subset of patients requiring mechanical ventilation
across all the MDCs.
Comment: One commenter disagreed with CMS' proposal to not create
new MS-DRGs for patients admitted with strokes and treated with
mechanical ventilation. The commenter expressed appreciation for CMS'
efforts in analyzing the cost and length of stay data for this subset
of patients. However, the commenter believed that the results of the
analysis identifying patients who receive mechanical ventilation >96
hours and also have an MCC demonstrate that these cases require twice
the cost of all cases in MS-DRG 61 (Ischemic Stroke, Precerebral
Occlusion or Transient Ischemia with Thrombolytic Agent with MCC) and
MS-DRG 64 (Intracranial Hemorrhage or Cerebral Infarction with MCC).
The commenter requested that CMS reconsider alternative options for
this subset of patients due to the cost and length of stay disparities.
Response: We acknowledge the commenters' concern that the average
length of stay and average costs for cases where mechanical ventilation
>96 hours was reported with an MCC for MS-DRG 61 and MS-DRG 64 are
greater when compared to the average length of stay and average costs
for all cases in those MS-DRGs. However, as stated in the FY 2019 IPPS/
LTCH PPS proposed rule (83 FR 20195), our clinical advisors noted that
patients requiring mechanical ventilation are known to be more resource
intensive and it would not be practical to create new MS-DRGs for this
subset of patients given the various other indications in which
mechanical ventilation may be utilized for other patients. We will
consider additional analysis in the future in our efforts toward a
broader approach to refining the MS-DRGs for cases of patients
requiring mechanical ventilation across the MDCs.
Comment: One commenter suggested that, although CMS' analysis of
the cases reporting a neurological condition with mechanical
ventilation was acceptable, CMS consider creating a new MS-DRG for
poisoning with mechanical ventilation in future rulemaking. The
commenter believed that a patient who is in critical condition as a
result of a poisoning and requires prolonged mechanical ventilation is
not being recognized appropriately under the current MS-DRG relative
payment weights.
Response: We appreciate the commenter's input and suggestion. As
noted earlier, we will consider additional analysis in our efforts
toward a broader approach to refining the MS-DRGs for cases of patients
requiring mechanical ventilation across the MDCs.
After consideration of the public comments we received, we are
finalizing our proposal to not create new MS-DRGs, classified under MDC
1, for cases that identify patients requiring mechanical ventilation
and are diagnosed with stroke or any other neurological condition with
or without a thrombolytic, and in the absence of an O.R. procedure for
FY 2019.
4. MDC 5 (Diseases and Disorders of the Circulatory System)
a. Pacemaker Insertions
In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56804 through
56809), we discussed a request to examine the ICD-10-PCS procedure code
combinations that describe procedures involving pacemaker insertions to
determine if some procedure code combinations were excluded from the
Version 33 ICD-10 MS-DRG assignments for MS-DRGs 242, 243, and 244
(Permanent Cardiac Pacemaker Implant with MCC, with CC, and without CC/
MCC, respectively) under MDC 5. We finalized our proposal to modify the
Version 34 ICD-10 MS-DRG GROUPER logic so the specified procedure code
combinations were no longer required for assignment into those MS-DRGs.
As a result, the logic for pacemaker insertion procedures was
simplified by separating the procedure codes describing cardiac
pacemaker device insertions into one list and separating the procedure
codes describing cardiac pacemaker lead insertions into another list.
Therefore, when any ICD-10-PCS procedure code describing the insertion
of a pacemaker device is reported from that specific logic list with
any ICD-10-PCS procedure code describing the insertion of a pacemaker
lead from that specific logic list (81 FR 56804 through 56806), the
case is assigned to MS-DRGs 242, 243, and 244 under MDC 5.
We then discussed our examination of the Version 33 GROUPER logic
for MS-DRGs 258 and 259 (Cardiac Pacemaker Device Replacement with and
without MCC, respectively) because assignment of cases to these MS-DRGs
also included qualifying ICD-10-PCS procedure code combinations
involving pacemaker insertions (81 FR 56806 through 56808).
Specifically, the logic for Version 33 ICD-10 MS-DRGs 258 and 259
included ICD-10-PCS procedure code combinations describing the removal
of pacemaker devices and the insertion of new pacemaker devices. We
finalized our proposal to modify the Version 34 ICD-10 MS-DRG GROUPER
logic for MS-DRGs 258 and 259 to establish that a case reporting any
procedure code from the list of ICD-10-PCS procedure codes describing
procedures involving pacemaker device insertions without any other
procedure
[[Page 41183]]
codes describing procedures involving pacemaker leads reported would be
assigned to MS-DRGs 258 and 259 (81 FR 56806 through 56807) under MDC
5. In addition, we pointed out that a limited number of ICD-10-PCS
procedure codes describing pacemaker insertion are classified as non-
operating room (non-O.R.) codes within the MS-DRGs and that the Version
34 ICD-10 MS-DRG GROUPER logic would continue to classify these
procedure codes as non-O.R. codes. We noted that a case reporting any
one of these non-O.R. procedure codes describing a pacemaker device
insertion without any other procedure code involving a pacemaker lead
would be assigned to MS-DRGs 258 and 259. Therefore, the listed
procedure codes describing a pacemaker device insertion under MS-DRGs
258 and 259 are designated as non-O.R. affecting the MS-DRG.
Lastly, we discussed our examination of the Version 33 GROUPER
logic for MS-DRGs 260, 261, and 262 (Cardiac Pacemaker Revision Except
Device Replacement with MCC, with CC, and without CC/MCC,
respectively), and noted that cases assigned to these MS-DRGs also
included lists of procedure code combinations describing procedures
involving the removal of pacemaker leads and the insertion of new
leads, in addition to lists of single procedure codes describing
procedures involving the insertion of pacemaker leads, removal of
cardiac devices, and revision of cardiac devices (81 FR 56808). We
finalized our proposal to modify the ICD-10 MS-DRG GROUPER logic for
MS-DRGs 260, 261, and 262 so that cases reporting any one of the listed
ICD-10-PCS procedure codes describing procedures involving pacemakers
and related procedures and associated devices are assigned to MS DRGs
260, 261, and 262 under MDC 5. Therefore, the GROUPER logic that
required a combination of procedure codes be reported for assignment
into MS-DRGs 260, 261 and 262 under Version 33 was no longer required
effective with discharges occurring on or after October 1, 2016 (FY
2017) under Version 34 of the ICD-10 MS-DRGs.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20198), we noted
that while the discussion in the FY 2017 IPPS/LTCH PPS final rule
focused on the MS-DRGs involving pacemaker procedures under MDC 5,
similar GROUPER logic exists in Version 33 of the ICD-10 MS-DRGs under
MDC 1 (Diseases and Disorders of the Nervous System) in MS-DRGs 040,
041 and 042 (Peripheral, Cranial Nerve and Other Nervous System
Procedures with MCC, with CC or Peripheral Neurostimulator and without
CC/MCC, respectively) and MDC 21 (Injuries, Poisonings and Toxic
Effects of Drugs) in MS-DRGs 907, 908, and 909 (Other O.R. Procedures
for Injuries with MCC, with CC, and without MCC, respectively) where
procedure code combinations involving cardiac pacemaker device
insertions or removals and cardiac pacemaker lead insertions or
removals are required to be reported together for assignment into those
MS-DRGs. We also noted that, with the exception of when a principal
diagnosis is reported from MDC 1, MDC 5, or MDC 21, the procedure codes
describing the insertion, removal, replacement, or revision of
pacemaker devices are assigned to a medical MS-DRG in the absence of
another O.R. procedure according to the GROUPER logic. We referred the
reader to the ICD-10 MS-DRG Definitions Manual Version 33, which is
available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
complete documentation of the GROUPER logic that was in effect at that
time for the Version 33 ICD-10 MS-DRGs discussed earlier.
As discussed in the FY 2019 IPS/LTCH PPS proposed rule (83 FR
20198), for FY 2019, we received a request to assign all procedures
involving the insertion of pacemaker devices to surgical MS-DRGs,
regardless of the principal diagnosis. The requestor recommended that
procedures involving pacemaker insertion be grouped to surgical MS-DRGs
within the MDC to which the principal diagnosis is assigned, or that
they group to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure
Unrelated to Principal Diagnosis with MCC, with CC and without CC/MCC,
respectively). Currently, in Version 35 of the ICD-10 MS-DRGs,
procedures involving pacemakers are assigned to MS-DRGs 040, 041, and
042 (Peripheral, Cranial Nerve and Other Nervous System Procedures with
MCC, with CC or Peripheral Neurostimulator and without CC/MCC,
respectively) under MDC 1 (Diseases and Disorders of the Nervous
System), to MS-DRGs 242, 243, and 244 (Permanent Cardiac Pacemaker
Implant with MCC, with CC, and without CC/MCC, respectively), MS-DRGs
258 and 259 (Cardiac Pacemaker Device Replacement with MCC and without
MCC, respectively), and MS-DRGs 260, 261 and 262 (Cardiac Pacemaker
Revision Except Device Replacement with MCC, with CC, and without CC/
MCC, respectively) under MDC 5 (Diseases and Disorders of the
Circulatory System), and to MS-DRGs 907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with CC, and without CC/MCC,
respectively), under MDC 21 (Injuries, Poisoning and Toxic Effects of
Drugs), with all other unrelated principal diagnoses resulting in a
medical MS-DRG assignment. According to the requestor, the medical MS-
DRGs do not provide adequate payment for the pacemaker device,
specialized operating suites, time, skills, and other resources
involved for pacemaker insertion procedures. Therefore, the requestor
recommended that procedures involving pacemaker insertions be grouped
to surgical MS-DRGs. We refer readers to the ICD-10 MS-DRG Definitions
Manual Version 35, which is available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
complete documentation of the GROUPER logic for the MS-DRGs discussed
earlier.
The following procedure codes describe procedures involving the
insertion of a cardiac rhythm related device which are classified as a
type of pacemaker insertion under the ICD-10 MS-DRGs. These four codes
are assigned to MS-DRGs 040, 041, and 042, as well as MS-DRGs 907, 908,
and 909, and are designated as O.R. procedures.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0JH60PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
open approach.
0JH63PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
percutaneous approach.
0JH80PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, open approach.
0JH83PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, percutaneous approach.
------------------------------------------------------------------------
[[Page 41184]]
We examined cases from the September update of the FY 2017 MedPAR
claims data for cases involving pacemaker insertion procedures
reporting the above ICD-10-PCS codes in MS-DRGs 040, 041 and 042 under
MDC 1. Our findings are shown in the following table.
Cases Involving Pacemaker Insertion Procedures in MDC 1
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 1 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 040--All cases........................................... 4,462 10.4 $26,877
MS-DRG 040--Cases with procedure code 0JH60PZ (Insertion of 13 14.2 55,624
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 040--Cases with procedure code 0JH63PZ (Insertion of 2 3.5 15,826
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 040--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 040--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 041--All cases........................................... 5,648 5.2 16,927
MS-DRG 041--Cases with procedure code 0JH60PZ (Insertion of 12 6.4 22,498
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 041--Cases with procedure code 0JH63PZ (Insertion of 4 5 17,238
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 041--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 041--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 042--All cases........................................... 2,154 3.1 13,730
MS-DRG 042--Cases with procedure code 0JH60PZ (Insertion of 5 8 18,183
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 042--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 042--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 042--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
----------------------------------------------------------------------------------------------------------------
The following table is a summary of the findings shown above from
our review of MS-DRGs 040, 041 and 042 and the total number of cases
reporting a pacemaker insertion procedure.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 1
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 1 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 040, 041, and 042--All cases............................ 12,264 6.7 $19,986
MS-DRGs 040, 041, and 042--Cases with a pacemaker insertion 36 9.1 32,906
procedure......................................................
----------------------------------------------------------------------------------------------------------------
We found a total of 12,264 cases in MS-DRGs 040, 041, and 042 with
an average length of stay of 6.7 days and average costs of $19,986. We
found a total of 36 cases in MS-DRGs 040, 041, and 042 reporting
procedure codes describing the insertion of a pacemaker device with an
average length of stay of 9.1 days and average costs of $32,906.
We then examined cases involving pacemaker insertion procedures
reporting those same four ICD-10-PCS procedure codes 0JH60PZ, 0JH63PZ,
0JH80PZ and 0JH83PZ in MS-DRGs 907, 908, and 909 under MDC 21. Our
findings are shown in the following table.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 21
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 21 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 907-All cases............................................ 7,405 10.1 $28,997
MS-DRG 907--Cases with procedure code 0JH60PZ (Insertion of 7 11.1 60,141
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 908--All cases........................................... 8,519 5.2 14,282
MS-DRG 908--Cases with procedure code 0JH60PZ (Insertion of 4 3.8 35,678
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 909--All cases........................................... 3,224 3.1 9,688
MS-DRG 909--Cases with procedure code 0JH60PZ (Insertion of 2 2 42,688
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
----------------------------------------------------------------------------------------------------------------
[[Page 41185]]
We note that there were no cases found where procedure codes
0JH63PZ, 0JH80PZ or 0JH83PZ were reported in MS-DRGs 907, 908 and 909
under MDC 21 and, therefore, they are not displayed in the table.
The following table is a summary of the findings shown above from
our review of MS-DRGs 907, 908, and 909 and the total number of cases
reporting a pacemaker insertion procedure.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 21
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 21 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 907, 908 and 909--All cases............................. 19,148 6.7 $19,199
MS-DRGs 907, 908 and 909--Cases with a pacemaker insertion 13 7.5 49,929
procedure......................................................
----------------------------------------------------------------------------------------------------------------
We found a total of 19,148 cases in MS-DRGs 907, 908, and 909 with
an average length of stay of 6.7 days and average costs of $19,199. We
found a total of 13 cases in MS-DRGs 907, 908, and 909 reporting
pacemaker insertion procedures with an average length of stay of 7.5
days and average costs of $49,929.
We also examined cases involving pacemaker insertion procedures
reporting the following procedure codes that are assigned to MS-DRGs
242, 243, and 244 under MDC 5.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0JH604Z................... Insertion of pacemaker, single chamber into
chest subcutaneous tissue and fascia, open
approach.
0JH605Z................... Insertion of pacemaker, single chamber rate
responsive into chest subcutaneous tissue
and fascia, open approach.
0JH606Z................... Insertion of pacemaker, dual chamber into
chest subcutaneous tissue and fascia, open
approach.
0JH607Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into chest
subcutaneous tissue and fascia, open
approach.
0JH60PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
open approach.
0JH634Z................... Insertion of pacemaker, single chamber into
chest subcutaneous tissue and fascia,
percutaneous approach.
0JH635Z................... Insertion of pacemaker, single chamber rate
responsive into chest subcutaneous tissue
and fascia, percutaneous approach.
0JH636Z................... Insertion of pacemaker, dual chamber into
chest subcutaneous tissue and fascia,
percutaneous approach.
0JH637Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into chest
subcutaneous tissue and fascia,
percutaneous approach.
0JH63PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
percutaneous approach.
0JH804Z................... Insertion of pacemaker, single chamber into
abdomen subcutaneous tissue and fascia,
open approach.
0JH805Z................... Insertion of pacemaker, single chamber rate
responsive into abdomen subcutaneous tissue
and fascia, open approach.
0JH806Z................... Insertion of pacemaker, dual chamber into
abdomen subcutaneous tissue and fascia,
open approach.
0JH807Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen
subcutaneous tissue and fascia, open
approach.
0JH80PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, open approach.
0JH834Z................... Insertion of pacemaker, single chamber into
abdomen subcutaneous tissue and fascia,
percutaneous approach.
0JH835Z................... Insertion of pacemaker, single chamber rate
responsive into abdomen subcutaneous tissue
and fascia, percutaneous approach.
0JH836Z................... Insertion of pacemaker, dual chamber into
abdomen subcutaneous tissue and fascia,
percutaneous approach.
0JH837Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen
subcutaneous tissue and fascia,
percutaneous approach.
0JH83PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, percutaneous approach.
------------------------------------------------------------------------
Our data findings are shown in the following table. We note that
procedure codes displayed with an asterisk (*) in the table are
designated as non-O.R. procedures affecting the MS-DRG.
Cases Involving Pacemaker Insertion Procedures in MDC 5
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 242--All cases........................................... 18,205 6.9 $26,414
MS-DRG 242--Cases with procedure code 0JH604Z* (Insertion of 2,518 7.7 25,004
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH605Z* (Insertion of 306 7.7 24,454
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH606Z* (Insertion of 13,323 6.7 25,497
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH607Z (Insertion of 1,528 8.1 37,060
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH60PZ (Insertion of 5 16.6 59,334
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 242--Cases with procedure code 0JH634Z* (Insertion of 65 8.5 26,789
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
[[Page 41186]]
MS-DRG 242--Cases with procedure code 0JH635Z* (Insertion of 10 7 35,104
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 242--Cases with procedure code 0JH636Z* (Insertion of 313 6.4 23,699
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 242--Cases with procedure code 0JH637Z (Insertion of 82 7.1 35,382
cardiac resynchronization pacemaker pulse generator into chest
Subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 242--Cases with procedure code 0JH63PZ (Insertion of 2 12.5 32,405
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 242--Cases with procedure code 0JH804Z* (Insertion of 25 14.4 43,080
pacemaker, single chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH805Z* (Insertion of 2 4 26,949
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH806Z* (Insertion of 50 6.8 25,306
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH807Z (Insertion of 5 21.2 67,908
cardiac resynchronization pacemaker pulse generator into
abdomen subcutaneous tissue and fascia, open approach).........
MS-DRG 242--Cases with procedure code 0JH836Z (Insertion of 1 5 36,111
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--All cases........................................... 24,586 4 18,669
MS-DRG 243--Cases with procedure code 0JH604Z* (Insertion of 2,537 4.7 17,118
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH605Z* (Insertion of 271 4.4 17,268
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH606Z* (Insertion of 19,921 3.9 18,306
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH607Z (Insertion of 1,236 4.4 28,658
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH60PZ (Insertion of 6 4.2 20,994
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 243--Cases with procedure code 0JH634Z* (Insertion of 55 5.2 16,784
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--Cases with procedure code 0JH635Z* (Insertion of 15 4.1 17,938
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 243--Cases with procedure code 0JH636Z* (Insertion of 431 3.7 16,164
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--Cases with procedure code 0JH637Z (Insertion of 58 5 28,926
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 243--Cases with procedure code 0JH63PZ (Insertion of 3 8.3 23,717
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 243--Cases with procedure code 0JH804Z* (Insertion of 10 8.2 20,871
pacemaker, single chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH805Z* (Insertion of 1 4 15,739
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH806Z* (Insertion of 57 4.4 18,787
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH807Z (Insertion of 3 4 19,653
cardiac resynchronization pacemaker pulse generator into
abdomen subcutaneous tissue and fascia, open approach).........
MS-DRG 243--Cases with procedure code 0JH80PZ (Insertion of 1 7 16,224
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 243--Cases with procedure code 0JH836Z* (Insertion of 1 2 14,005
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 244--All cases........................................... 15,974 2.7 15,670
MS-DRG 244--Cases with procedure code 0JH604Z* (Insertion of 1,045 3.2 14,541
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 244--Cases with procedure code 0JH605Z* (Insertion of 127 3 13,208
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH606Z* (Insertion of 14,092 2.7 15,596
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 244--Cases with procedure code 0JH607Z (Insertion of 303 2.8 26,221
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH60PZ (Insertion of 2 4.5 9,248
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 244--Cases with procedure code 0JH634Z* (Insertion of 32 2.8 11,525
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 244--Cases with procedure code 0JH635Z* (Insertion of 1 2 30,100
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 244--Cases with procedure code 0JH636Z* (Insertion of 320 2.6 13,670
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
[[Page 41187]]
MS-DRG 244--Cases with procedure code 0JH637Z (Insertion of 20 2.7 19,218
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 244--Cases with procedure code 0JH63PZ (Insertion of 1 3 12,120
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 244--Cases with procedure code 0JH805Z* (Insertion of 1 1 21,604
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH806Z* (Insertion of 36 3.2 16,492
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 244--Cases with procedure code 0JH836Z* (Insertion of 1 3 12,160
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
----------------------------------------------------------------------------------------------------------------
The following table is a summary of the findings shown above from
our review of MS-DRGs 242, 243, and 244 and the total number of cases
reporting a pacemaker insertion procedure.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 5
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 242, 243 and 244--All cases............................. 58,765 4.6 $20,253
MS-DRGs 242, 243, and 244--Cases with a pacemaker insertion * 58,822 4.6 20,270
procedure......................................................
----------------------------------------------------------------------------------------------------------------
* The figure is not adjusted for cases reporting more than one pacemaker insertion procedure code. The figure
represents the frequency in which the number of pacemaker insertion procedures was reported.
We found a total of 58,765 cases in MS-DRGs 242, 243, and 244 with
an average length of stay of 4.6 days and average costs of $20,253. We
found a total of 58,822 cases reporting pacemaker insertion procedures
in MS-DRGs 242, 243, and 244 with an average length of stay of 4.6 days
and average costs of $20,270. We note that the analysis performed is by
procedure code, and because multiple pacemaker insertion procedures may
be reported on a single claim, the total number of these pacemaker
insertion procedure cases exceeds the total number of all cases found
across MS-DRGs 242, 243, and 244 (58,822 procedures versus 58,765
cases).
We then analyzed claims for cases reporting a procedure code
describing (1) the insertion of a pacemaker device only, (2) the
insertion of a pacemaker lead only, and (3) both the insertion of a
pacemaker device and a pacemaker lead across all the MDCs except MDC 5
to determine the number of cases currently grouping to medical MS-DRGs
and the potential impact of these cases moving into the surgical
unrelated MS-DRGs 981, 982 and 983 (Extensive O.R. Procedure Unrelated
to Principal Diagnosis with MCC, with CC and without CC/MCC,
respectively). Our findings are shown in the following table.
Pacemaker Insertion Procedures in Medical MS-DRGs
----------------------------------------------------------------------------------------------------------------
Number of Average length
All MDCs except MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for insertion of pacemaker device.................... 2,747 9.5 $29,389
Procedures for insertion of pacemaker lead...................... 2,831 9.4 29,240
Procedures for insertion of pacemaker device with insertion of 2,709 9.4 29,297
pacemaker lead.................................................
----------------------------------------------------------------------------------------------------------------
We found a total of 2,747 cases reporting the insertion of a
pacemaker device in 177 medical MS-DRGs with an average length of stay
of 9.5 days and average costs of $29,389 across all the MDCs except MDC
5. We found a total of 2,831 cases reporting the insertion of a
pacemaker lead in 175 medical MS-DRGs with an average length of stay of
9.4 days and average costs of $29,240 across all the MDCs except MDC 5.
We found a total of 2,709 cases reporting both the insertion of a
pacemaker device and the insertion of a pacemaker lead in 170 medical
MS-DRGs with an average length of stay of 9.4 days and average costs of
$29,297 across all the MDCs except MDC 5.
We also analyzed claims for cases reporting a procedure code
describing the insertion of a pacemaker device with a procedure code
describing the insertion of a pacemaker lead in all the surgical MS-
DRGs across all the MDCs except MDC 5. Our findings are shown in the
following table.
[[Page 41188]]
Pacemaker Insertion Procedures in Surgical MS-DRGs
----------------------------------------------------------------------------------------------------------------
Average length
All MDCs except MDC 5 Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for insertion of pacemaker device with insertion 3,667 12.8 $48,856
of pacemaker lead...........................................
----------------------------------------------------------------------------------------------------------------
We found a total of 3,667 cases reporting the insertion of a
pacemaker device and the insertion of a pacemaker lead in 194 surgical
MS-DRGs with an average length of stay of 12.8 days and average costs
of $48,856 across all the MDCs except MDC 5.
For cases where the insertion of a pacemaker device, the insertion
of a pacemaker lead or the insertion of both a pacemaker device and
lead were reported on a claim grouping to a medical MS-DRG, the average
length of stay and average costs were generally higher for these cases
when compared to the average length of stay and average costs for all
the cases in their assigned MS-DRGs. For example, we found 113 cases
reporting both the insertion of a pacemaker device and lead in MS-DRG
378 (G.I. Hemorrhage with CC), with an average length of stay of 7.1
days and average costs of $23,711. The average length of stay for all
cases in MS-DRG 378 was 3.6 days and the average cost for all cases in
MS-DRG 378 was $7,190. The average length of stay for cases reporting
both the insertion of a pacemaker device and lead were twice as long as
the average length of stay for all the cases in MS-DRG 378 (7.1 days
versus 3.6 days). In addition, the average costs for the cases
reporting both the insertion of a pacemaker device and lead were
approximately $16,500 higher than the average costs of all the cases in
MS-DRG 378 ($23,711 versus $7,190). We refer readers to Table 6P.1c
associated with the proposed rule (which is available via the internet
on the CMS website) for the detailed report of our findings across the
other medical MS-DRGs. We note that the average costs and average
length of stay for cases reporting the insertion of a pacemaker device,
the insertion of a pacemaker lead or the insertion of both a pacemaker
device and lead are reflected in Columns D and E, while the average
costs and average length of stay for all cases in the respective MS-DRG
are reflected in Columns I and J.
The claims data results from our analysis of this request showed
that if we were to support restructuring the GROUPER logic so that
pacemaker insertion procedures that include a combination of the
insertion of the pacemaker device with the insertion of the pacemaker
lead are designated as an O.R. procedure across all the MDCs, we would
expect approximately 2,709 cases to move or ``shift'' from the medical
MS-DRGs where they are currently grouping into the surgical unrelated
MS-DRGs 981, 982, and 983.
Our clinical advisors reviewed the data results and recommended
that pacemaker insertion procedures involving a complete pacemaker
system (insertion of pacemaker device combined with insertion of
pacemaker lead) warrant classification into surgical MS-DRGs because
the patients receiving these devices demonstrate greater treatment
difficulty and utilization of resources when compared to procedures
that involve the insertion of only the pacemaker device or the
insertion of only the pacemaker lead. We note that the request we
addressed in the FY 2017 IPPS/LTCH PPS proposed rule (81 FR 24981
through 24984) was to determine if some procedure code combinations
were excluded from the ICD-10 MS-DRG assignments for MS-DRGs 242, 243,
and 244. We proposed and, upon considering public comments received,
finalized an alternate approach that we believed to be less
complicated. We also stated in the FY 2017 IPPS/LTCH PPS final rule (81
FR 56806) that we would continue to monitor the MS-DRGs for pacemaker
insertion procedures as we receive ICD-10 claims data. Upon further
review, we stated that we believe that recreating the procedure code
combinations for pacemaker insertion procedures would allow for the
grouping of these procedures to the surgical MS-DRGs, which we believe
is warranted to better recognize the resources and complexity of
performing these procedures. Therefore, in the FY 2019 IPPS/LTCH PPS
proposed rule (83 FR 20203), we proposed to recreate pairs of procedure
code combinations involving both the insertion of a pacemaker device
with the insertion of a pacemaker lead to act as procedure code
combination pairs or ``clusters'' in the GROUPER logic that are
designated as O.R. procedures outside of MDC 5 when reported together.
Comment: Commenters supported the proposal to recreate pairs of
procedure code combinations involving both the insertion of a pacemaker
device with the insertion of a pacemaker lead to act as procedure code
combination pairs or ``clusters'' in the GROUPER logic that are
designated as O.R. procedures outside of MDC 5 when reported together.
One commenter specifically expressed its appreciation of CMS' efforts
to update the MS-DRG GROUPER logic to better recognize the resources
and complexity of pacemaker device and lead procedures. Another
commenter disagreed with the proposal to use pacemaker code pairs for
assignment to a surgical MS-DRG, stating it would be more appropriate
to designate each pacemaker device and pacemaker lead procedure code as
an O.R. procedure to allow initial insertions and replacement of
individual components to group to surgical MS-DRGs within all MDCs.
According to the commenter, this designation would compensate providers
for the cost of the device and the resources utilized in the
performance of initial insertions and the replacement of individual
components.
Response: We appreciate the commenters' support. With regard to the
commenter who disagreed with the proposal to utilize pacemaker code
pairs for assignment to a surgical MS-DRG and suggested that the
GROUPER logic designate each pacemaker device and pacemaker lead
procedure code as an O.R. procedure to allow initial insertions and
replacement of individual components to group to surgical MS-DRGs
within all MDCs, we note that, as displayed in Table 6P.1c. associated
with the FY 2019 IPPS/LTCH PPS proposed rule (which is available via
the internet on the CMS website), our claims analysis for cases
reporting a procedure code describing the insertion of a pacemaker
device only demonstrated a total of six cases across all the medical
MS-DRGs, and for cases reporting a procedure code describing the
insertion of a pacemaker lead only, the data demonstrated a total of
four cases across all the medical MS-DRGs. As a result, there were a
total of only 10 cases where a stand-alone code for insertion of a
pacemaker device procedure or a stand-alone code for insertion of a
pacemaker lead procedure was reported. Those 10 cases grouped to 10
different medical MS-DRGs, of which 8 included a CC or MCC diagnosis.
Therefore, it is not clear how much of the average costs, the average
length of stay, the complexity of service, and resource utilization for
those cases
[[Page 41189]]
are attributable to the insertion of the pacemaker device/lead
procedure versus the severity of illness.
After consideration of the public comments we received, we are
finalizing our proposal to recreate pairs of procedure code
combinations involving both the insertion of a pacemaker device with
the insertion of a pacemaker lead to act as procedure code combination
pairs or ``clusters'' in the GROUPER logic that are designated as O.R.
procedures outside of MDC 5 when reported together under the ICD-10 MS-
DRGs Version 36, effective October 1, 2018.
We also proposed to designate all the procedure codes describing
the insertion of a pacemaker device or the insertion of a pacemaker
lead as non-O.R. procedures when reported as a single, individual
stand-alone code based on the recommendation of our clinical advisors
as noted in the proposed rule and earlier in this section and
consistent with how these procedures were classified under the Version
33 ICD-10 MS-DRG GROUPER logic.
Comment: A number of commenters supported the proposal to designate
all the procedure codes describing the insertion of a pacemaker device
or the insertion of a pacemaker lead as non-O.R. procedures when
reported as a single, individual stand-alone code. However, other
commenters opposed the proposal. One commenter acknowledged that the
complexity of inserting a full pacemaker system is greater than when
inserting a pacemaker lead or generator. However, this commenter
asserted that the complexity does not increase significantly and that
the placement of a lead or generator still requires the use of an
operating room, sterile field, anesthesiology, and preparing the
patient. The commenter believed that the placement of a pacemaker lead
or device does require the use of an operating room and expressed
concern that CMS would designate the procedures as a non-O.R.
procedure.
Response: We appreciate the commenters' support. With regard to the
commenter who expressed concern that we proposed to designate procedure
codes describing the insertion of a pacemaker device or the insertion
of a pacemaker lead as non-O.R. procedures when reported as a single,
individual stand-alone code, we note that historically, these
procedures have been designated as non-O.R. procedures. As we noted in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20203), our proposal to
designate all the procedure codes describing the insertion of a
pacemaker device or the insertion of a pacemaker lead as non-O.R.
procedures when reported as a single, individual stand-alone code is
consistent with how these procedures were classified under the Version
33 ICD-10 MS-DRG GROUPER logic. In addition, our clinical advisors
continue to support the non-O.R. designation because, as the commenter
noted in its own comments, while these procedures may require a sterile
field, anesthesia and preparing the patient, the complexity of
inserting a pacemaker lead or generator alone is less than that of
inserting a full pacemaker system and the former can be performed in
settings such as cardiac catheterization laboratories.
After consideration of the public comments we received, we are
finalizing our proposal to designate all the procedure codes describing
the insertion of a pacemaker device or the insertion of a pacemaker
lead as non-O.R. procedures when reported as a single, individual
stand-alone code outside of MDC 5 under the ICD-10 MS-DRGs Version 36,
effective October 1, 2018.
In the proposed rule, we referred readers to Table 6P.1d, Table
6P.1e, and Table 6P.1f. associated with the proposed rule (which is
available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) for (1) a complete list of the proposed
procedure code combinations or ``pairs''; (2) a complete list of the
procedure codes describing the insertion of a pacemaker device; and (3)
a complete list of the procedure codes describing the insertion of a
pacemaker lead. We invited public comments on our lists of procedure
codes that we proposed to include for restructuring the ICD-10 MS-DRG
GROUPER logic for pacemaker insertion procedures.
In addition, we proposed to maintain the current GROUPER logic for
MS-DRGs 258 and 259 (Cardiac Pacemaker Device Replacement with MCC and
without MCC, respectively) where the listed procedure codes as shown in
the ICD-10 MS-DRG Definitions Manual Version 35, which is available via
the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending,
describing a pacemaker device insertion, continue to be designated as
``non-O.R. affecting the MS-DRG'' because they are reported when a
pacemaker device requires replacement and have a corresponding
diagnosis from MDC 5. Also, we proposed to maintain the current GROUPER
logic for MS-DRGs 260, 261, and 262 (Cardiac Pacemaker Revision Except
Device Replacement with MCC, with CC, and without CC/MCC, respectively)
so that cases reporting any one of the listed ICD-10-PCS procedure
codes as shown in the ICD-10 MS-DRG Definitions Manual Version 35
describing procedures involving pacemakers and related procedures and
associated devices will continue to be assigned to those MS DRGs under
MDC 5 because they are reported when a pacemaker device requires
revision and they have a corresponding circulatory system diagnosis.
Comment: Commenters agreed with the proposed lists of procedure
codes for restructuring the ICD-10 MS DRG GROUPER logic for pacemaker
insertion procedures. One commenter also suggested the addition of ICD-
10-PCS procedure code 02H63MZ (Insertion of cardiac lead into right
atrium, percutaneous approach) and ICD-10-PCS procedure code 02H73MZ
(Insertion of cardiac lead into left atrium, percutaneous approach) to
Tables 6P.1d. and Table 6P.1f. that were associated with the proposed
rule. The commenter noted that the tables included the open and
percutaneous endoscopic approaches but did not include the percutaneous
approach.
Response: We appreciate the commenters' support. We agree with the
commenter to add ICD-10-PCS procedure codes 02H63MZ and 02H73MZ to
Table 6P.1d and as reflected in Table 6P.1f. associated with this final
rule (which is available via the internet on the CMS website), to be
included for the pacemaker insertion code pairs and as stand-alone
codes for the insertion of a pacemaker lead. The codes are consistent
with the other insertion of cardiac lead procedures and were
inadvertently omitted from the initial list.
After consideration of the public comments we received, we are
finalizing the lists of the procedure codes in Tables 6P.1d., Table
6P.1e., and Table 6P.1f associated with the proposed rule, with the
addition of ICD-10-PCS procedure codes 02H63MZ and 02H73MZ to be
included for the pacemaker insertion code pairs and as stand-alone
codes for the insertion of a pacemaker lead, as reflected in Tables
6P.1.d. and 6P.1.f. associated with this final rule. We also are
finalizing our proposal to maintain the current GROUPER logic for MS-
DRGs 258 and 259 and for MS-DRGs 260, 261, and 262
[[Page 41190]]
under the ICD-10 Version 36, effective October 1, 2018.
We noted in the proposed rule that, while the requestor did not
include the following procedure codes in its request, these codes are
also currently designated as O.R. procedure codes and are assigned to
MS-DRGs 260, 261, and 262 under MDC 5.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02PA0MZ............................. Removal of cardiac lead from
heart, open approach.
02PA3MZ............................. Removal of cardiac lead from
heart, percutaneous approach.
02PA4MZ............................. Removal of cardiac lead from
heart, percutaneous endoscopic
approach.
02WA0MZ............................. Revision of cardiac lead in heart,
open approach.
02WA3MZ............................. Revision of cardiac lead in heart,
percutaneous approach.
02WA4MZ............................. Revision of cardiac lead in heart,
percutaneous endoscopic approach.
0JPT0PZ............................. Removal of cardiac rhythm related
device from trunk subcutaneous
tissue and fascia, open approach.
0JPT3PZ............................. Removal of cardiac rhythm related
device from trunk subcutaneous
tissue and fascia, percutaneous
approach.
0JWT0PZ............................. Revision of cardiac rhythm related
device in trunk subcutaneous
tissue and fascia, open approach.
0JWT3PZ............................. Revision of cardiac rhythm related
device in trunk subcutaneous
tissue and fascia, percutaneous
approach.
------------------------------------------------------------------------
In the proposed rule, we solicited public comments on whether these
procedure codes describing the removal or revision of a cardiac lead
and removal or revision of a cardiac rhythm related (pacemaker) device
should also be designated as non-O.R. procedure codes for FY 2019 when
reported as a single, individual stand-alone code with a principal
diagnosis outside of MDC 5 for consistency in the classification among
these devices.
Comment: One commenter recommended that CMS not finalize the
proposed designation of the procedure codes listed in the above table
describing the removal or revisions of a cardiac lead and the removal
or revision of a cardiac rhythm related (pacemaker) device from O.R.
procedures to non-O.R. procedures when reported as a single, individual
stand-alone code when reported with a principal diagnosis outside of
MDC 5. Another commenter expressed concern that the rationale for the
proposal was not clear and warranted additional clarification about the
data used to arrive at this recommendation. According to this
commenter, regardless of the principal diagnosis, the resources for
procedures involving insertion, removal or revision of a pacemaker
generator or lead are the same. The commenter further noted that
revisions are often more complex and require greater resources. The
commenter recommended that CMS continue to designate the procedures as
O.R. procedures and further explain the proposal.
Response: We appreciate the commenter's feedback. We note that
while we were soliciting comments on the procedure codes listed in the
table above that describe the removal or revision of a cardiac lead and
the removal or revision of a cardiac rhythm related (pacemaker) device,
we did not specifically recommend a change to the designation of the
procedure codes at this time. We agree with the commenter that the
removal or revision of a cardiac lead or pacemaker generator can be
more complex and require greater resources than an initial insertion
procedure.
After consideration of the public comments we received, we are
maintaining the O.R. designation of the procedure codes listed in the
above table under the ICD-10 MS-DRGs Version 36, effective October 1,
2018. As additional claims data become available, we will continue to
analyze these procedures.
We also note in the proposed rule that, while the requestor did not
include the following procedure codes in its request, the codes in the
following table became effective October 1, 2016 (FY 2017) and also
describe procedures involving the insertion of a pacemaker.
Specifically, the following list includes procedure codes that describe
an intracardiac or ``leadless'' pacemaker. These procedure codes are
designated as O.R. procedure codes and are currently assigned to MS-
DRGs 228 and 229 (Other Cardiothoracic Procedures with MCC and without
MCC, respectively) under MDC 5.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02H40NZ................... Insertion of intracardiac pacemaker into
coronary vein, open approach.
02H43NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous approach.
02H44NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous endoscopic
approach.
02H60NZ................... Insertion of intracardiac pacemaker into
right atrium, open approach.
02H63NZ................... Insertion of intracardiac pacemaker into
right atrium, percutaneous approach.
02H64NZ................... Insertion of intracardiac pacemaker into
right atrium, percutaneous endoscopic
approach.
02H70NZ................... Insertion of intracardiac pacemaker into
left atrium, open approach.
02H73NZ................... Insertion of intracardiac pacemaker into
left atrium, percutaneous approach.
02H74NZ................... Insertion of intracardiac pacemaker into
left atrium, percutaneous endoscopic
approach.
02HK0NZ................... Insertion of intracardiac pacemaker into
right ventricle, open approach.
02HK3NZ................... Insertion of intracardiac pacemaker into
right ventricle, percutaneous approach.
02HK4NZ................... Insertion of intracardiac pacemaker into
right ventricle, percutaneous endoscopic
approach.
02HL0NZ................... Insertion of intracardiac pacemaker into
left ventricle, open approach.
02HL3NZ................... Insertion of intracardiac pacemaker into
left ventricle, percutaneous Approach.
02HL4NZ................... Insertion of intracardiac pacemaker into
left ventricle, percutaneous endoscopic
approach.
02WA0NZ................... Revision of intracardiac pacemaker in heart,
open approach.
02WA3NZ................... Revision of intracardiac pacemaker in heart,
percutaneous approach.
02WA4NZ................... Revision of intracardiac pacemaker in heart,
percutaneous endoscopic approach.
02WAXNZ................... Revision of intracardiac pacemaker in heart,
external approach.
02H40NZ................... Insertion of intracardiac pacemaker into
coronary vein, open approach.
[[Page 41191]]
02H43NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous approach.
------------------------------------------------------------------------
We examined claims data for procedures involving an intracardiac
pacemaker reporting any of the above codes across all MS-DRGs. Our
findings are shown in the following table.
Intracardiac Pacemaker Procedures
----------------------------------------------------------------------------------------------------------------
Average length
Across all MS-DRGs Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for intracardiac pacemaker........................ 1,190 8.6 $38,576
----------------------------------------------------------------------------------------------------------------
We found 1,190 cases reporting a procedure involving an
intracardiac pacemaker with an average length of stay of 8.6 days and
average costs of $38,576. Of these 1,190 cases, we found 1,037 cases in
MS-DRGs under MDC 5. We also found that the 153 cases that grouped to
MS-DRGs outside of MDC 5 grouped to surgical MS-DRGs; therefore,
another O.R. procedure was also reported on the claim. However, in the
FY 2019 IPPS/LTCH PPS proposed rule, we solicited public comments on
whether these procedure codes describing the insertion and revision of
intracardiac pacemakers should also be considered for classification
into all surgical unrelated MS-DRGs outside of MDC 5 for FY 2019.
Comment: Commenters supported classifying the procedure codes
listed in the table above describing the insertion and revision of
intracardiac pacemakers into all surgical unrelated MS-DRGs outside of
MDC 5.
Response: We appreciate the commenters' feedback. We note that
while we solicited comments on the procedure codes listed in the table
above that describe the insertion of an intracardiac pacemaker device,
we did not specifically recommend a change to the designation of the
procedure codes at this time. We also note that, currently, the
procedures are already classified within the GROUPER logic as extensive
O.R. procedures. Therefore, if one of the procedure codes is reported
with a principal diagnosis outside of MDC 5, the case will group to one
of the unrelated surgical MS-DRGs.
After consideration of the public comments we received, we are
maintaining the O.R. designation of the procedure codes listed in the
above table under the ICD-10 MS-DRGs Version 36, effective October 1,
2018. As additional claims data become available, we will continue to
analyze these procedures.
b. Drug-Coated Balloons in Endovascular Procedures
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38111), we
discontinued new technology add-on payments for the LUTONIX[supreg] and
IN.PACTTM AdmiralTM drug-coated balloon (DCB)
technologies, effective for FY 2018, because the technology no longer
met the newness criterion for new technology add-on payments. For FY
2019, we received a request to reassign cases that utilize a drug-
coated balloon in the performance of an endovascular procedure
involving the treatment of superficial femoral arteries for peripheral
arterial disease from the lower severity level MS-DRG 254 (Other
Vascular Procedures without CC/MCC) and MS-DRG 253 (Other Vascular
Procedures with CC) to the highest severity level MS-DRG 252 (Other
Vascular Procedures with MCC). We also received a request to revise the
title of MS-DRG 252 to ``Other Vascular Procedures with MCC or Drug-
Coated Balloon Implant''.
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20205), there are currently 36 ICD-10-PCS procedure codes that describe
the performance of endovascular procedures involving treatment of the
superficial femoral arteries that utilize a drug-coated balloon, which
are listed in the following table.
------------------------------------------------------------------------
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.
[[Page 41192]]
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.
------------------------------------------------------------------------
The requestor performed its own analysis of claims data and
expressed concern that it found that the average costs of cases using a
drug-coated balloon in the performance of percutaneous endovascular
procedures involving treatment of patients who have been diagnosed with
peripheral arterial disease are significantly higher than the average
costs of all of the cases in the MS-DRGs where these procedures are
currently assigned. The requestor also expressed concern that payments
may no longer be adequate because the new technology add-on payments
have been discontinued and may affect patient access to these
procedures.
We first examined claims data from the September 2017 update of the
FY 2017 MedPAR file for cases reporting any 1 of the 36 ICD-10-PCS
procedure codes listed in the immediately preceding table that describe
the use of a drug-coated balloon in the performance of endovascular
procedures in MS-DRGs 252, 253, and 254. Our findings are shown in the
following table.
MS-DRGs for Other Vascular Procedures With Drug[dash]Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 252--All cases........................................... 33,583 7.6 $23,906
MS-DRG 252--Cases with drug-coated balloon...................... 870 8.8 30,912
MS-DRG 253--All cases........................................... 25,714 5.4 18,986
MS-DRG 253--Cases with drug-coated balloon...................... 1,532 5.4 23,051
MS-DRG 254--All cases........................................... 12,344 2.8 13,287
MS-DRG 254--Cases with drug-coated balloon...................... 488 2.4 17,445
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 33,583 cases in MS-
DRG 252, with an average length of stay of 7.6 days and average costs
of $23,906. There were 870 cases in MS-DRG 252 reporting the use of a
drug-coated balloon in the performance of an endovascular procedure,
with an average length of stay of 8.8 days and average costs of
$30,912. The total number of cases in MS-DRG 253 was 25,714, with an
average length of stay of 5.4 days and average costs of $18,986. There
were 1,532 cases in MS-DRG 253 reporting the use of a DCB in the
performance of an endovascular procedure, with an average length of
stay of 5.4 days and average costs of $23,051. The total number of
cases in MS-DRG 254 was 12,344, with an average length of stay of 2.8
days and average costs of $13,287. There were 488 cases in MS-DRG 254
reporting the use of a DCB in the performance of an endovascular
procedure, with an average length of stay of 2.4 days and average costs
of $17,445.
The results of our data analysis show that there is not a very high
volume of cases reporting the use of a drug-coated balloon in the
performance of endovascular procedures compared to all of the cases in
the assigned MS-DRGs. The data results also show that the average
length of stay for cases reporting the use of a drug-coated balloon in
the performance of endovascular procedures in MS-DRGs 253 and 254 is
lower compared to the average length of stay for all of the cases in
the assigned MS-DRGs, while the average length of stay for cases
reporting the use of a drug-coated balloon in the performance of
endovascular procedures in MS-DRG 252 is slightly higher compared to
all of the cases in MS-DRG 252 (8.8 days versus 7.6 days). Lastly, the
data results showed that the average costs for cases reporting the use
of a drug-coated balloon in the performance of percutaneous
endovascular procedures were higher compared to all of the cases in the
assigned MS-DRGs. Specifically, for MS-DRG 252, the average costs for
cases reporting the use of a DCB in the performance of endovascular
procedures were $30,912 versus the average costs of $23,906 for all
cases in MS-DRG 252, a difference of $7,006. For MS-DRG 253, the
average costs for cases reporting the use of a drug-coated balloon in
the performance of endovascular procedures were $23,051 versus the
average costs of $18,986 for all cases in MS-DRG 253, a difference
[[Page 41193]]
of $4,065. For MS-DRG 254, the average costs for cases reporting the
use of a drug-coated balloon in the performance of endovascular
procedures were $17,445 versus the average costs of $13,287 for all
cases in MS-DRG 254, a difference of $4,158.
The following table is a summary of the findings discussed above
from our review of MS-DRGs 252, 253 and 254 and the total number of
cases that used a drug-coated balloon in the performance of the
procedure across MS-DRGs 252, 253, and 254.
MS-DRGs for Other Vascular Procedures and Cases With Drug-Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 252, 253, and 254--All cases............................ 71,641 6.0 $20,310
MS-DRGs 252, 253, and 254--Cases with drug-coated balloon....... 2,890 6.0 24,569
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 71,641 cases across
MS-DRGs 252, 253, and 254, with an average length of stay of 6.0 days
and average costs of $20,310. There were a total of 2,890 cases across
MS-DRGs 252, 253, and 254 reporting the use of a drug-coated balloon in
the performance of the procedure, with an average length of stay of 6.0
days and average costs of $24,569. The data analysis showed that cases
reporting the use of a drug-coated balloon in the performance of the
procedure across MS-DRGs 252, 253 and 254 have similar lengths of stay
(6.0 days) compared to the average length of stay for all of the cases
in MS-DRGs 252, 253, and 254. The data results also showed that the
cases reporting the use of a drug-coated balloon in the performance of
the procedure across these MS-DRGs have higher average costs ($24,569
versus $20,310) compared to the average costs for all of the cases
across these MS-DRGs.
We stated in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20207)
that the results of our claims data analysis and the advice from our
clinical advisors did not support reassigning cases reporting the use
of a drug-coated balloon in the performance of these procedures from
the lower severity level MS-DRGs 253 and 254 to the highest severity
level MS-DRG 252 at this time. We further stated that, if we were to
reassign cases that utilize a drug-coated balloon in the performance of
these types of procedures from MS-DRG 254 to MS-DRG 252, the cases
would result in overpayment and also would have a shorter length of
stay compared to all of the cases in MS-DRG 252. While the cases
reporting the use of a drug-coated balloon in the performance of these
procedures are higher compared to the average costs for all cases in
their assigned MS-DRGs, it is not by a significant amount. We stated
that we believe that as use of a drug-coated balloon becomes more
common, the costs will be reflected in the data. Our clinical advisors
also agreed that it would not be clinically appropriate to reassign
cases for patients from the lowest severity level (without CC/MCC) MS-
DRG to the highest severity level (with MCC) MS-DRG in the absence of
additional data to better determine the resource utilization for this
subset of patients. Therefore, for these reasons, we proposed to not
reassign cases reporting the use of a drug-coated balloon in the
performance of endovascular procedures from MS-DRGs 253 and 254 to MS-
DRG 252.
Comment: A number of commenters supported maintaining the current
classification of cases involving the use of a drug-coated balloon in
the performance of endovascular procedures. The commenters stated that
CMS' proposal was reasonable, given the data, ICD-10-PCS procedure
codes, and information provided.
Response: We appreciate the commenters' support.
Comment: One commenter recommended that further data analysis be
conducted after the new ICD-10-PCS procedure codes for endovascular
procedures utilizing a drug-coated balloon in the upper extremity
become effective on October 1, 2018, in order to determine if MS-DRG
structure and assignment modifications are warranted in the future.
Response: We agree with the commenter that continued monitoring of
the cases reporting the use of a drug-coated balloon in the performance
of endovascular procedures in the lower extremity, along with analysis
of the new ICD-10-PCS procedure codes that identify the use of a drug-
coated balloon in the upper extremity, would be advantageous. As claims
data become available, we will be able to evaluate the resource
utilization of these procedures more effectively.
Comment: One commenter believed that an analysis of the average
costs of cases performed with and without the use of drug-coated
balloons in MS-DRGs 252, 253, and 254 justified assigning cases,
including cases involving the use of drug-coated balloons in the
performance of the procedure, to MS-DRGs 252 or 253, and not to MS-DRG
254. The commenter indicated that claims data showed the average costs
of MS-DRG 253 for all cases is $18,986, while the average cost of cases
utilizing drug-coated balloons in the performance of the procedure
assigned to MS-DRG 254 is $17,445. The commenter believed that, while
the average length-of-stay is lower for these cases, the average costs
are consistent with that of MS-DRG 253. Therefore, the commenter
suggested that CMS reassign these cases to MS-DRG 253 as a more
appropriate reflection of the hospital resources utilized for these
cases.
Response: Our clinical advisors reviewed the data, and again
determined that it would not be clinically appropriate to reassign
cases for patients from the lowest severity level (without CC/MCC) MS-
DRG to the higher severity level (with CC) MS-DRG in the absence of
additional data to better determine the resource utilization for this
subset of patients. We reiterate that we believe as use of the drug-
coated balloon in the performance of endovascular procedures becomes
more common, the costs will be reflected in the data. In addition, as
noted above, new ICD-10-PCS procedure codes that describe the use of a
drug-coated balloon in the upper extremity are effective with
discharges occurring on or after October 1, 2018. As such, we will
continue to monitor cases reporting the use of a drug-coated balloon in
the performance of endovascular procedures and determine if future MS-
DRG structure and assignment modifications are supported.
After consideration of the public comments we received, we are
finalizing our proposal to not reassign cases reporting the use of a
drug-coated balloon in the performance of endovascular procedures from
MS-DRGs 253 and 254 to MS-DRG 252 for FY 2019.
We noted in the proposed rule that because 24 of the 36 ICD-10-PCS
procedure codes describing the use of a
[[Page 41194]]
drug-coated balloon in the performance of endovascular procedures also
include the use of an intraluminal device, we conducted further
analysis to determine the number of cases reporting an intraluminal
device with the use of a drug-coated balloon in the performance of the
procedure versus the number of cases reporting the use of a drug-coated
balloon alone. We analyzed the number of cases across MS-DRGs 252, 253,
and 254 reporting: (1) The use of an intraluminal device (stent) with
use of a drug-coated balloon in the performance of the procedure; (2)
the use of a drug-eluting intraluminal device (stent) with the use of a
drug-coated balloon in the performance of the procedure; and (3) the
use of a drug-coated balloon only in the performance of the procedure.
Our findings are shown in the following table.
MS-DRGs for Other Vascular Procedures and Cases With Drug-Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 252, 253 and 254--All cases............................. 71,641 6.0 $20,310
MS-DRGs 252, 253 and 254--Cases with intraluminal device with 522 6.0 28,418
drug-coated balloon............................................
MS-DRGs 252, 253 and 254--Cases with drug-eluting intraluminal 447 6.0 26,098
device with drug-coated balloon................................
MS-DRGs 252, 253 and 254--Cases with drug-coated balloon only... 2,705 6.1 24,553
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 71,641 cases across
MS-DRGs 252, 253, and 254, with an average length of stay of 6.0 days
and average costs of $20,310. There were 522 cases across MS-DRGs 252,
253, and 254 reporting the use of an intraluminal device with use of a
drug-coated balloon in the performance of the procedure, with an
average length of stay of 6.0 days and average costs of $28,418. There
were 447 cases across MS-DRGs 252, 253, and 254 reporting the use of a
drug-eluting intraluminal device with use of a drug-coated balloon in
the performance of the procedure, with an average length of stay of 6.0
days and average costs of $26,098. Lastly, there were 2,705 cases
across MS-DRGs 252, 253, and 254 reporting the use of a drug-coated
balloon alone in the performance of the procedure, with an average
length of stay of 6.1 days and average costs of $24,553.
The data showed that the 2,705 cases in MS-DRGs 252, 253, and 254
reporting the use of a drug-coated balloon alone in the performance of
the procedure have lower average costs compared to the 969 cases in MS-
DRGs 252, 253, and 254 reporting the use of an intraluminal device (522
cases) or a drug-eluting intraluminal device (447 cases) with a drug-
coated balloon in the performance of the procedure ($24,553 versus
$28,418 and $26,098, respectively.) The data also showed that the cases
reporting the use of a drug-coated balloon alone in the performance of
the procedure have a comparable average length of stay compared to the
cases reporting the use of an intraluminal device or a drug-eluting
intraluminal device with a drug-coated balloon in the performance of
the procedure (6.1 days versus 6.0 days).
In summary, as we stated in the proposed rule, we believe that
further analysis of endovascular procedures involving the treatment of
superficial femoral arteries for peripheral arterial disease that
utilize a drug-coated balloon in the performance of the procedure would
be advantageous. As additional claims data become available, we will be
able to more fully evaluate the differences in cases where a procedure
utilizes a drug-coated balloon alone in the performance of the
procedure versus cases where a procedure utilizes an intraluminal
device or a drug-eluting intraluminal device in addition to a drug-
coated balloon in the performance of the procedure.
5. MDC 6 (Diseases and Disorders of the Digestive System)
a. Benign Lipomatous Neoplasm of Kidney
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20207), we received a request to reassign ICD-10-CM diagnosis code
D17.71 (Benign lipomatous neoplasm of kidney) from MDC 06 (Diseases and
Disorders of the Digestive System) to MDC 11 (Diseases and Disorders of
the Kidney and Urinary Tract). The requestor stated that this diagnosis
code is used to describe a kidney neoplasm and believed that because
the ICD-10-CM code is specific to the kidney, a more appropriate
assignment would be under MDC 11. In FY 2015, under the ICD-9-CM
classification, there was not a specific diagnosis code for a benign
lipomatous neoplasm of the kidney. The only diagnosis code available
was ICD-9-CM diagnosis code 214.3 (Lipoma of intra-abdominal organs),
which was assigned to MS-DRGs 393, 394, and 395 (Other Digestive System
Diagnoses with MCC, with CC, and without CC/MCC, respectively) under
MDC 6. Therefore, when we converted from the ICD-9 based MS-DRGs to the
ICD-10 MS-DRGs, there was not a specific code available that identified
the kidney from which to replicate. As a result, ICD-10-CM diagnosis
code D17.71 was assigned to those same MS-DRGs (MS-DRGs 393, 394, and
395) under MDC 6.
While reviewing the MS-DRG classification of ICD-10-CM diagnosis
code D17.71, we also reviewed the MS-DRG classification of another
diagnosis code organized in subcategory D17.7, ICD-10-CM diagnosis code
D17.72 (Benign lipomatous neoplasm of other genitourinary organ). ICD-
10-CM diagnosis code D17.72 is currently assigned under MDC 09
(Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast) to
MS-DRGs 606 and 607 (Minor Skin Disorders with and without MCC,
respectively). Similar to the replication issue with ICD-10-CM
diagnosis code D17.71, with ICD-10-CM diagnosis code D17.72, under the
ICD-9-CM classification, there was not a specific diagnosis code to
identify a benign lipomatous neoplasm of genitourinary organ. The only
diagnosis code available was ICD-9-CM diagnosis code 214.8 (Lipoma of
other specified sites), which was assigned to MS-DRGs 606 and 607 under
MDC 09. Therefore, when we converted from the ICD-9 based MS-DRGs to
the ICD-10 MS-DRGs, there was not a specific code available that
identified another genitourinary organ (other than the kidney) from
which to replicate. As a result, ICD-10-CM diagnosis code D17.72 was
assigned to those same MS-DRGs (MS-DRGs 606 and 607) under MDC 9.
In the proposed rule, we proposed to reassign ICD-10-CM diagnosis
code D17.71 from MS-DRGs 393, 394, and 395 (Other Digestive System
Diagnoses with MCC, with CC, and without CC/MCC, respectively) under
MDC 06 to
[[Page 41195]]
MS-DRGs 686, 687, and 688 (Kidney and Urinary Tract Neoplasms with MCC,
with CC, and without CC/MCC, respectively) under MDC 11 because this
diagnosis code is used to describe a kidney neoplasm. We also proposed
to reassign ICD-10-CM diagnosis code D17.72 from MS-DRGs 606 and 607
under MDC 09 to MS-DRGs 686, 687, and 688 under MDC 11 because this
diagnosis code is used to describe other types of neoplasms classified
to the genitourinary tract that do not have a specific code identifying
the site. Our clinical advisors agreed that the conditions described by
the ICD-10-CM diagnosis codes provide specific anatomic detail
involving the kidney and genitourinary tract and, therefore, if
reclassified under this proposed MDC and reassigned to these MS-DRGs,
would improve the clinical coherence of the patients assigned to these
groups.
Comment: Commenters agreed with CMS' proposals to reassign ICD-10-
CM diagnosis code D17.71 that describes benign lipomatous neoplasm of
the kidney from MDC 6 to MDC 11, and to reassign ICD-10-CM diagnosis
code D17.72 that describes benign lipomatous neoplasm of other
genitourinary tract organ from MDC 9 to MDC 11. The commenters stated
the proposals were reasonable, given the ICD-10-CM diagnosis codes and
information provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposals to reassign ICD-10-CM diagnosis code D17.71
from MS-DRGs 393, 394, and 395 under MDC 6 to MS-DRGs 686, 687, and 688
under MDC 11, and to reassign ICD-10-CM diagnosis code D17.72 from MS-
DRGs 606 and 607 under MDC 9 to MS-DRGs 686, 687, and 688 under MDC 11
in the ICD-10 MS-DRGs Version 36, effective October 1, 2018.
b. Bowel Procedures
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20208), we received a request to reassign the following 8 ICD-10-PCS
procedure codes that describe repositioning of the colon and takedown
of end colostomy from MS-DRGs 344, 345, and 346 (Minor Small and Large
Bowel Procedures with MCC, with CC, and without CC/MCC, respectively)
to MS-DRGs 329, 330, and 331 (Major Small and Large Bowel Procedures
with MCC, with CC, and without CC/MCC, respectively):
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DSK0ZZ................... Reposition ascending colon, open approach.
0DKL4ZZ................... Reposition ascending colon, percutaneous
endoscopic approach.
0DSL0ZZ................... Reposition transverse colon, open approach.
0DSL4ZZ................... Reposition transverse colon, percutaneous
endoscopic approach.
0DSM0ZZ................... Reposition descending colon, open approach.
0DSM4ZZ................... Reposition descending colon, percutaneous
endoscopic approach.
0DSN0ZZ................... Reposition sigmoid colon, open approach.
0DSN4ZZ................... Reposition sigmoid colon, percutaneous
endoscopic approach.
------------------------------------------------------------------------
The requestor indicated that the resources required for procedures
identifying repositioning of specified segments of the large bowel are
more closely aligned with other procedures that group to MS-DRGs 329,
330, and 331, such as repositioning of the large intestine (unspecified
segment).
We analyzed the claims data from the September 2017 update of the
FY 2017 Med PAR file for MS-DRGs 344, 345 and 346 for all cases
reporting the 8 ICD-10-PCS procedure codes listed in the table above.
Our findings are shown in the following table:
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 344--All cases........................................... 1,452 9.5 $20,609
MS-DRG 344--All cases with a specific large bowel reposition 52 9.6 23,409
procedure......................................................
MS-DRG 345--All cases........................................... 2,674 5.6 11,552
MS-DRG 345--All cases with a specific large bowel reposition.... 246 6 14,915
MS-DRG 346--All cases........................................... 990 3.8 8,977
MS-DRG 346--All cases with a specific large bowel reposition 223 4.5 12,279
procedure......................................................
----------------------------------------------------------------------------------------------------------------
The data showed that the average length of stay and average costs
for cases that reported a specific large bowel reposition procedure
were generally consistent with the average length of stay and average
costs for all of the cases in their assigned MS-DRG.
We then examined the claims data in the September 2017 update of
the FY 2017 MedPAR file for MS-DRGs 329, 330 and 331. Our findings are
shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 329, 330, and 331--All cases............................ 112,388 8.4 $21,382
MS-DRG 329--All cases........................................... 33,640 13.3 34,015
MS-DRG 330--All cases........................................... 52,644 7.3 17,896
MS-DRG 331--All cases........................................... 26,104 4.1 12,132
----------------------------------------------------------------------------------------------------------------
[[Page 41196]]
As shown in this table, across MS-DRGs 329, 330, and 331, we found
a total of 112,388 cases, with an average length of stay of 8.4 days
and average costs of $21,382. We stated in the FY 2019 IPPS/LTCH PPS
proposed rule that the results of our analysis indicate that the
resources required for cases reporting the specific large bowel
repositioning procedures are more aligned with those resources required
for all cases assigned to MS-DRGs 344, 345, and 346, with the average
costs being lower than the average costs for all cases assigned to MS-
DRGs 329, 330, and 331. Our clinical advisors also indicated that the 8
specific bowel repositioning procedures are best aligned with those in
MS-DRGs 344, 345, and 346. Therefore, in the FY 2019 IPPS/LTCH PPS
proposed rule (83 FR 20209), we proposed to maintain the current
assignment of the 8 specific bowel repositioning procedures in MS-DRGs
344, 345, and 346 for FY 2019.
Comment: Commenters supported CMS' proposal to maintain the current
assignment of the 8 specific bowel repositioning procedures in MS DRGs
344, 345, and 346 for FY 2019.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current assignment of the 8
specific bowel repositioning procedures in MS DRGs 344, 345, and 346
for FY 2019.
In conducting our analysis of MS-DRGs 329, 330, and 331, we also
examined the subset of cases reporting one of the bowel procedures
listed in the following table as the only O.R. procedure.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DQK0ZZ................... Repair ascending colon, open approach.
0DQK4ZZ................... Repair ascending colon, percutaneous
endoscopic approach.
0DQL0ZZ................... Repair transverse colon, open approach.
0DQL4ZZ................... Repair transverse colon, percutaneous
endoscopic approach.
0DQM0ZZ................... Repair descending colon, open approach.
0DQM4ZZ................... Repair descending colon, percutaneous
endoscopic approach.
0DQN0ZZ................... Repair sigmoid colon, open approach.
0DQN4ZZ................... Repair sigmoid colon, percutaneous
endoscopic approach.
0DSB0ZZ................... Reposition ileum, open approach.
0DSB4ZZ................... Reposition ileum, percutaneous endoscopic
approach.
0DSE0ZZ................... Reposition large intestine, open approach.
0DSE4ZZ................... Reposition large intestine, percutaneous
endoscopic approach.
------------------------------------------------------------------------
This approach can be useful in determining whether resource use is
truly associated with a particular procedure or whether the procedure
frequently occurs in cases with other procedures with higher than
average resource use. As shown in the following table, we identified
398 cases reporting a bowel procedure as the only O.R. procedure, with
an average length of stay of 6.3 days and average costs of $13,595
across MS-DRGs 329, 330, and 331, compared to the overall average
length of stay of 8.4 days and average costs of $21,382 for all cases
in MS-DRGs 329, 330, and 331.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 329, 330 and 331--All cases............................. 112,388 8.4 $21,382
MS-DRGs 329, 330 and 331--All cases with a bowel procedure as 398 6.3 13,595
only O.R. procedure............................................
MS-DRG 329--All cases........................................... 33,640 13.3 34,015
MS-DRG 329--Cases with a bowel procedure as only O.R. procedure. 86 8.3 19,309
MS-DRG 330--All cases........................................... 52,644 7.3 17,896
MS-DRG 330--Cases with a bowel procedure as only O.R. procedure. 183 6.9 13,617
MS-DRG 331--All cases........................................... 26,104 4.1 12,132
MS-DRG 331--Cases with a bowel procedure as only O.R. procedure. 129 4.3 9,754
----------------------------------------------------------------------------------------------------------------
We stated in the FY 2019 IPPS/LTCH PPS proposed rule that the
resources required for these cases are more aligned with the resources
required for cases assigned to MS-DRGs 344, 345, and 346 than with the
resources required for cases assigned to MS-DRGs 329, 330, and 331. Our
clinical advisors also agreed that these cases are more clinically
aligned with cases in MS-DRGs 344, 345, and 346, as they are minor
procedures relative to the major bowel procedures assigned to MS-DRGs
329, 330, and 331. Therefore, in the proposed rule, we proposed to
reassign the 12 ICD-10-PCS procedure codes listed above from MS-DRGs
329, 330, and 331 to MS-DRGs 344, 345, and 346.
Comment: Commenters disagreed with CMS' proposal to reassign the 12
ICD-10-PCS procedure codes listed above from MS-DRGs 329, 330, and 331
to MS DRGs 344, 345, and 346. The commenters recommended that changes
to these MS-DRGs be delayed until a thorough data analysis is
conducted. The commenters further recommended that any future analysis
include a thorough review of the principal diagnoses for cases
involving these ICD-10-PCS codes, as the associated diagnosis
significantly impacts the resource utilization and complexity of the
procedure performed and MS-DRG assignment. The commenters noted that
the root operation of ``Reposition'' may be used for the takedown of a
stoma, as well as to treat a specific medical condition such as
malrotation of the intestine, and that ``Repair'' is the root operation
of last resort when no other ICD-10-PCS root operation applies and,
therefore, is used for a wide range of procedures of varying
complexity.
Commenters also noted that several questions and answers regarding
these ICD-10-PCS procedure codes were published in Coding Clinic for
ICD-10-CM/PCS between late 2016 and the end of 2017, and stated that
because 2 full
[[Page 41197]]
years of data were not available subsequent to publication of this
advice, CMS' analysis and proposed MS-DRG modifications may be based on
unreliable data.
Response: Upon further review, we agree with the commenters that
the availability of a full 2 years of data would allow us to conduct a
more comprehensive analysis upon which to consider potential
modifications to these MS-DRGs. Therefore, we believe it would be
preferable to wait until these data are available before finalizing
changes to the MS-DRG assignment for these bowel procedures.
After consideration of the public comments we received, we are not
finalizing our proposal to reassign the 12 ICD-10-PCS procedure codes
listed above from MS-DRGs 329, 330, and 331 to MS-DRGs 344, 345, and
346 for FY 2019.
6. MDC 8 (Diseases and Disorders of the Musculoskeletal System and
Connective Tissue): Spinal Fusion
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38036), we announced
our plans to review the ICD-10 logic for the MS-DRGs where procedures
involving spinal fusion are currently assigned for FY 2019. After
publication of the FY 2018 IPPS/LTCH PPS final rule, we received a
comment suggesting that CMS publish findings from this review and
discuss possible future actions. The commenter agreed that it is
important to be able to fully evaluate the MS-DRGs to which all spinal
fusion procedures are currently assigned with additional claims data,
particularly considering the 33 clinically invalid codes that were
identified through the rulemaking process (82 FR 38034 through 38035)
and the 87 codes identified from the upper and lower joint fusion
tables in the ICD-10-PCS classification and discussed at the September
12, 2017 ICD-10 Coordination and Maintenance Committee that were
proposed to be deleted effective October 1, 2018 (FY 2019). The agenda
and handouts from that meeting can be obtained from the CMS website at:
https://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html.
According to the commenter, deleting the 33 procedure codes
describing clinically invalid spinal fusion procedures for FY 2018
partially resolves the issue for data used in setting the FY 2020
payment rates. However, the commenter also noted that the problem will
not be fully resolved until the FY 2019 claims are available for FY
2021 ratesetting (due to the 87 codes identified at the ICD-10
Coordination and Maintenance Committee meeting for deletion effective
October 1, 2018 (FY 2019)).
The commenter noted that it analyzed claims data from the FY 2016
MedPAR data set and was surprised to discover a significant number of
discharges reporting 1 of the 87 clinically invalid codes that were
identified and discussed by the ICD-10 Coordination and Maintenance
Committee among the following spinal fusion MS-DRGs.
------------------------------------------------------------------------
MS-DRG Description
------------------------------------------------------------------------
453....................... Combined Anterior/Posterior Spinal Fusion
with MCC.
454....................... Combined Anterior/Posterior Spinal Fusion
with CC.
455....................... Combined Anterior/Posterior Spinal Fusion
without CC/MCC.
456....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions with MCC.
457....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions with CC.
458....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions without CC/MCC.
459....................... Spinal Fusion Except Cervical with MCC.
460....................... Spinal Fusion Except Cervical without MCC.
471....................... Cervical Spinal Fusion with MCC.
472....................... Cervical Spinal Fusion with CC.
473....................... Cervical Spinal Fusion without CC/MCC.
------------------------------------------------------------------------
In addition, the commenter noted that it also identified a number
of discharges for the 33 clinically invalid codes we identified in the
FY 2018 IPPS/LTCH PPS final rule in the same MS-DRGs listed above.
According to the commenter, its findings of these invalid spinal fusion
procedure codes in the FY 2016 claims data comprise approximately 30
percent of all discharges for spinal fusion procedures.
The commenter expressed its appreciation that CMS is making efforts
to address coding inaccuracies within the classification and suggested
that CMS publish findings from its own review of spinal fusion coding
issues in those MS-DRGs where cases reporting spinal fusion procedures
are currently assigned and include a discussion of possible future
actions in the FY 2019 IPPS/LTCH PPS proposed rule. The commenter
believed that such an approach would allow time for stakeholder input
on any possible proposals along with time for the invalid codes to be
worked out of the datasets. The commenter also noted that publishing
CMS' findings will put the agency, as well as the public, in a better
position to address any potential payment issues for these services
beginning in FY 2021.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20210), we
thanked the commenter for acknowledging the steps we have taken in our
efforts to address coding inaccuracies within the classification as we
continue to refine the ICD-10 MS-DRGs. We did not propose any changes
to the MS-DRGs involving spinal fusion procedures for FY 2019. However,
in response to the commenter's suggestion and findings, we provided the
following results from our analysis of the September 2017 update of the
FY 2017 MedPAR claims data for the MS-DRGs involving spinal fusion
procedures.
We noted that while the commenter stated that 87 codes were
identified from the upper and lower joint fusion tables in the ICD-10-
PCS classification and discussed at the September 12, 2017 ICD-10
Coordination and Maintenance Committee meeting to be deleted effective
October 1, 2018 (FY 2019), there were 99 spinal fusion codes identified
in the meeting materials, as shown in Table 6P.1g associated with the
proposed rule (which is available via the internet on the CMS website
at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
As shown in Table 6P.1g associated with the proposed rule, the 99
procedure codes describe spinal fusion procedures that have device
value ``Z'' representing No Device for the 6th character in the code.
Because a spinal fusion procedure always requires some type of device
(for example, instrumentation with bone graft or bone
[[Page 41198]]
graft alone) to facilitate the fusion of vertebral bones, these codes
are considered clinically invalid and were proposed for deletion at the
September 12, 2017 ICD-10 Coordination and Maintenance Committee
meeting. We received public comments in support of the proposal to
delete the 99 codes describing a spinal fusion without a device, in
addition to receiving support for the deletion of other procedure codes
describing fusion of body sites other than the spine. A total of 213
procedure codes describing fusion of a specific body part with device
value ``Z'' No Device are being deleted effective October 1, 2018 (FY
2019) as shown in Table 6D.--Invalid Procedure Codes associated with
the proposed rule and this final rule (which is available via the
internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
We examined claims data from the September 2017 update of the FY
2017 MedPAR file for cases reporting any of the clinically invalid
spinal fusion procedures with device value ``Z'' No Device in MS-DRGs
028 (Spinal Procedures with MCC), 029 (Spinal Procedures with CC or
Spinal Neurostimulators), and 030 (Spinal Procedures without CC/MCC)
under MDC 1 and MS-DRGs 453, 454, 455, 456, 457, 458, 459, 460, 471,
472, and 473 under MDC 8 (that are listed and shown earlier in this
section). Our findings are shown in the following tables.
Spinal Fusion Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 028--All cases........................................... 1,927 11.7 $37,524
MS-DRG 028--Cases with invalid spinal fusion procedures......... 132 13 52,034
MS-DRG 029--All cases........................................... 3,426 5.7 22,525
MS-DRG 029--Cases with invalid spinal fusion procedures......... 171 7.4 33,668
MS-DRG 030--All cases........................................... 1,578 3 15,984
MS-DRG 030--Cases with invalid spinal fusion procedures......... 52 2.6 22,471
MS-DRG 453--All cases........................................... 2,891 9.5 70,005
MS-DRG 453--Cases with invalid spinal fusion procedures......... 823 10.1 84,829
MS-DRG 454--All cases........................................... 12,288 4.7 47,334
MS-DRG 454--Cases with invalid spinal fusion procedures......... 2,473 5.4 59,814
MS-DRG 455--All cases........................................... 12,751 3 37,440
MS-DRG 455--Cases with invalid spinal fusion procedures......... 2,332 3.2 45,888
MS-DRG 456--All cases........................................... 1,439 11.5 66,447
MS-DRG 456--Cases with invalid spinal fusion procedures......... 404 12.5 71,385
MS-DRG 457--All cases........................................... 3,644 6 48,595
MS-DRG 457--Cases with invalid spinal fusion procedures......... 960 6.7 53,298
MS-DRG 458--All cases........................................... 1,368 3.6 37,804
MS-DRG 458--Cases with invalid spinal fusion procedures......... 244 4.1 43,182
MS-DRG 459--All cases........................................... 4,904 7.8 43,862
MS-DRG 459--Cases with invalid spinal fusion procedures......... 726 9 49,387
MS-DRG 460--All cases........................................... 59,459 3.4 29,870
MS-DRG 460--Cases with invalid spinal fusion procedures......... 5,311 3.9 31,936
MS-DRG 471--All cases........................................... 3,568 8.4 36,272
MS-DRG 471--Cases with invalid spinal fusion procedures......... 389 9.9 43,014
MS-DRG 472--All cases........................................... 15,414 3.2 21,836
MS-DRG 472--Cases with invalid spinal fusion procedures......... 1,270 4 25,780
MS-DRG 473--All cases........................................... 18,095 1.8 17,694
MS-DRG 473--Cases with invalid spinal fusion procedures......... 1,185 2.3 19,503
----------------------------------------------------------------------------------------------------------------
Summary Table for Spinal Fusion Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 142,752 3.9 $31,788
471, 472, and 473--All cases...................................
MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 16,472 5.1 42,929
471, 472, and 473--Cases with invalid spinal fusion procedures.
----------------------------------------------------------------------------------------------------------------
As shown in this summary table, we found a total of 142,752 cases
in MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 471,
472, and 473 with an average length of stay of 3.9 days and average
costs of $31,788. We found a total of 16,472 cases reporting a
procedure code for an invalid spinal fusion procedure with device value
``Z'' No Device across MS-DRGs 028, 029, and 030 under MDC 1 and MS-
DRGs 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and 473 under
MDC 8, with an average length of stay of 5.1 days and average costs of
$42,929. The results of the data analysis demonstrate that these
invalid spinal fusion procedures represent approximately 12 percent of
all discharges across the spinal fusion MS-DRGs. Because these
procedure codes describe clinically invalid procedures, we would not
expect these codes to be reported on any claims data. We stated in the
proposed rule that it is unclear why providers assigned procedure codes
for spinal fusion procedures with the device value ``Z'' No Device. Our
analysis did not examine whether these claims were isolated to a
specific provider or whether this inaccurate reporting was widespread
among a number of providers.
[[Page 41199]]
With regard to possible future action, we indicated in the proposed
rule that we will continue to monitor the claims data for resolution of
the coding issues previously identified. Because the procedure codes
that we analyzed and presented findings for in the FY 2019 IPPS/LTCH
PPS proposed rule will no longer be in the classification system,
effective October 1, 2018 (FY 2019), the claims data that we examine
for FY 2020 may still contain claims with the invalid codes. As such,
we will continue to collaborate with the AHA as one of the four
Cooperating Parties through the AHA's Coding Clinic for ICD-10-CM/PCS
and provide further education on spinal fusion procedures and the
proper reporting of the ICD-10-PCS spinal fusion procedure codes. We
agreed with the commenter that until these coding inaccuracies are no
longer reflected in the claims data, it would be premature to propose
any MS-DRG modifications for spinal fusion procedures. Possible MS-DRG
modifications may include taking into account the approach that was
utilized in performing the spinal fusion procedure (for example, open
versus percutaneous).
For the reasons described and as stated in the proposed rule and
earlier in our discussion, we proposed not to make any changes to the
spinal fusion MS-DRGs for FY 2019.
Comment: Commenters agreed with CMS' proposal not to make any
changes to the MS-DRGs involving spinal fusion procedures for FY 2019.
Response: We thank the commenters for their support.
Comment: Some commenters noted that confusion has existed as to
whether a spinal fusion code may be assigned when no bone graft or bone
graft substitute is used (that is, instrumentation only) but the
medical record documentation refers to the procedure as a spinal
fusion. One commenter recommended that additional refinements be made
to the ICD-10-PCS spinal fusion coding guidelines in order to further
clarify appropriate reporting of spinal fusion codes. Another commenter
asserted that the planned deletion of a total of 213 ICD-10-PCS fusion
procedure codes with the device value ``Z'' for ``no device'',
effective October 1, 2018, should help remedy the confusion regarding
the correct coding of spinal procedures.
Response: We agree with the commenters that accurate coding of
spinal fusion procedures has been the subject of confusion in the past,
and we will continue to monitor the claims data for spinal fusion
procedures. As one of the four Cooperating Parties, we also will
continue to collaborate with the American Hospital Association to
provide guidance for coding spinal fusion procedures through the Coding
Clinic for ICD-10-CM/PCS publication and to review the ICD-10-PCS
spinal fusion coding guidelines to determine where further
clarifications may be made.
After consideration of the public comments we received, we are
finalizing our proposal to not make any changes to the spinal fusion
MS-DRGs for FY 2019.
7. MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue and
Breast): Cellulitis With Methicillin Resistant Staphylococcus Aureus
(MRSA) Infection
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20212), we received a request to reassign ICD-10-CM diagnosis codes
reported with a principal diagnosis of cellulitis and a secondary
diagnosis code of B95.62 (Methicillin resistant Staphylococcus aureus
infection as the cause of diseases classified elsewhere) or A49.02
(Methicillin resistant Staphylococcus aureus infection, unspecified
site). Currently, these cases are assigned to MS-DRG 602 (Cellulitis
with MCC) and MS-DRG 603 (Cellulitis without MCC) in MDC 9. The
requestor believed that cases of cellulitis with MSRA infection should
be reassigned to MS-DRG 867 (Other Infectious and Parasitic Diseases
Diagnoses with MCC) because MS-DRGs 602 and 603 include cases that do
not accurately reflect the severity of illness or risk of mortality for
patients diagnosed with cellulitis and MRSA. The requestor acknowledged
that the organism is not to be coded before the localized infection,
but stated in its request that patients diagnosed with cellulitis and
MRSA are entirely different from patients diagnosed only with
cellulitis. The requestor stated that there is a genuine threat to life
or limb in these cases. The requestor further stated that, with the
opioid crisis and the frequency of MRSA infection among this
population, cases of cellulitis with MRSA should be identified with a
specific combination code and assigned to MS-DRG 867.
For the FY 2019 IPPS/LTCH PPS proposed rule, we analyzed claims
data from the September 2017 update of the FY 2017 MedPAR file for all
cases assigned to MS-DRGs 602 and 603 and subsets of these cases
reporting a principal ICD-10-CM diagnosis of cellulitis and a secondary
diagnosis code of B95.62 or A49.02. Our findings are shown in the
following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 602--All cases........................................... 26,244 5.8 $10,034
MS-DRG 603--All cases........................................... 104,491 3.9 6,128
MS-DRGs 602 and 603--Cases reported with a principal diagnosis 5,364 5.3 8,245
of cellulitis and a secondary diagnosis of B95.62..............
MS-DRGs 602 and 603--Cases reported with a principal diagnosis 309 5.4 8,832
of cellulitis and a secondary diagnosis of A49.02..............
----------------------------------------------------------------------------------------------------------------
As shown in this table, we examined the subsets of cases in MS-DRGs
602 and 603 reported with a principal diagnosis of cellulitis and a
secondary diagnosis code B95.62 or A49.02. Both of these subsets of
cases had an average length of stay that was comparable to the average
length of stay for all cases in MS-DRG 602 and greater than the average
length of stay for all cases in MS-DRG 603, and average costs that were
lower than the average costs of all cases in MS-DRG 602 and higher than
the average costs of all cases in MS-DRG 603. As we have discussed in
prior rulemaking (77 FR 53309), it is a fundamental principle of an
averaged payment system that half of the procedures in a group will
have above average costs. It is expected that there will be higher cost
and lower cost subsets, especially when a subset has low numbers.
To examine the request to reassign ICD-10-CM diagnosis codes
reported with a principal diagnosis of cellulitis and a secondary
diagnosis code of B95.62 or A49.02 from MS-DRGs 602 and 603 to MS-DRG
867 (which would typically involve also reassigning those cases to the
two other severity level MS-DRGs 868 and 869 (Other Infectious
[[Page 41200]]
and Parasitic Diseases Diagnoses with CC and Other Infectious and
Parasitic Diseases Diagnoses without CC/MCC, respectively)), we then
analyzed the data for all cases in MS-DRGs 867, 868 and 869. The
results of our analysis are shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 867--All cases........................................... 2,653 7.5 $14,762
MS-DRG 868--All cases........................................... 2,096 4.4 7,532
MS-DRG 869--All cases........................................... 499 3.3 5,624
----------------------------------------------------------------------------------------------------------------
We compared the average length of stay and average costs for MS-
DRGs 867, 868, and 869 to the average length of stay and average costs
for the subsets of cases in MS-DRGs 602 and 603 reported with a
principal diagnosis of cellulitis and a secondary diagnosis code of
B95.62 or A49.02. We found that the average length of stay for these
subsets of cases was shorter and the average costs were lower than
those for all cases in MS-DRG 867, but that the average length of stay
and average costs were higher than those for all cases in MS-DRG 868
and MS-DRG 869. We stated in the proposed rule that our findings from
the analysis of claims data do not support reassigning cellulitis cases
reported with ICD-10-CM diagnosis code B95.62 or A49.02 from MS-DRGs
602 and 603 to MS-DRGs 867, 868 and 869. Our clinical advisors noted
that when a principal diagnosis of cellulitis is accompanied by a
secondary diagnosis of B95.62 or A49.02 in MS-DRGs 602 or 603, the
combination of these primary and secondary diagnoses is the reason for
the hospitalization, and the level of acuity of these subsets of
patients is similar to other patients in MS-DRGs 602 and 603.
Therefore, in the proposed rule, we stated that these cases are more
clinically aligned with all cases in MS-DRGs 602 and 603. For these
reasons, we did not propose to reassign cellulitis cases reported with
ICD-10-CM diagnosis code of B95.62 or A49.02 to MS-DRG 867, 868, or 869
for FY 2019. We invited public comments on our proposal to maintain the
current MS-DRG assignment for ICD-10-CM codes B95.62 and A49.02 when
reported as secondary diagnoses with a principal diagnosis of
cellulitis.
Comment: One commenter supported CMS' proposal to maintain the
current MS-DRG assignment for ICD-10-CM codes B95.62 and A49.02 when
reported as secondary diagnoses with a principal diagnosis of
cellulitis.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current MS-DRG classification
for cases reported with ICD-10-CM diagnosis codes B95.62 and A49.02
when reported as secondary diagnoses with a principal diagnosis of
cellulitis.
8. MDC 10 (Endocrine, Nutritional and Metabolic Diseases and
Disorders): Acute Intermittent Porphyria
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20212), we received a request to revise the MS-DRG classification for
cases of patients diagnosed with porphyria and reported with ICD-10-CM
diagnosis code E80.21 (Acute intermittent (hepatic) porphyria) to
recognize the resource requirements in caring for these patients, to
ensure appropriate payment for these cases, and to preserve patient
access to necessary treatments. Porphyria is defined as a group of rare
disorders (``porphyrias'') that interfere with the production of
hemoglobin that is needed for red blood cells. While some of these
disorders are genetic (inborn) and others are acquired, they all result
in the abnormal accumulation of hemoglobin building blocks, called
porphyrins, which can be deposited in the tissues where they
particularly interfere with the functioning of the nervous system and
the skin. Treatment for patients suffering from disorders of porphyrin
metabolism consists of an intravenous injection of Panhematin[supreg]
(hemin for injection). ICD-10-CM diagnosis code E80.21 is currently
assigned to MS-DRG 642 (Inborn and Other Disorders of Metabolism). (We
note that this issue has been discussed previously in the FY 2013 IPPS/
LTCH PPS proposed and final rules (77 FR 27904 through 27905 and 77 FR
53311 through 53313, respectively) and the FY 2015 IPPS/LTCH PPS
proposed and final rules (79 FR 28016 and 79 FR 49901, respectively)).
We analyzed claims data from the September 2017 update of the FY
2017 MedPAR file for cases assigned to MS-DRG 642. Our findings are
shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 642 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 642--All cases........................................... 1,801 4.3 $9,157
MS-DRG 642--Cases reporting diagnosis code E80.21 as principal 183 5.6 19,244
diagnosis......................................................
MS-DRG 642--Cases not reporting diagnosis code E80.21 as 1,618 4.1 8,016
principal diagnosis............................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, cases reporting diagnosis code E80.21 as
the principal diagnosis in MS-DRG 642 had higher average costs and
longer average lengths of stay compared to the average costs and
lengths of stay for all other cases in MS-DRG 642.
To examine the request to reassign cases with ICD-10-CM diagnosis
code E80.21 as the principal diagnosis, we analyzed claims data for all
cases in MS-DRGs for endocrine disorders, including MS-DRG 643
(Endocrine Disorders with MCC), MS-DRG 644 (Endocrine Disorders with
CC), and MS-DRG 645 (Endocrine Disorders without CC/MCC). The results
of our analysis are shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 643--All cases........................................... 9,337 6.3 $11,268
[[Page 41201]]
MS-DRG 644--All cases........................................... 11,306 4.2 7,154
MS-DRG 645--All cases........................................... 4,297 3.2 5,406
----------------------------------------------------------------------------------------------------------------
The data results showed that the average length of stay for the
subset of cases reporting ICD-10-CM diagnosis code E80.21 as the
principal diagnosis in MS-DRG 642 is lower than the average length of
stay for all cases in MS-DRG 643, but higher than the average length of
stay for all cases in MS-DRGs 644 and 645. The average costs for the
subset of cases reporting ICD-10-CM diagnosis code E80.21 as the
principal diagnosis in MS-DRG 642 are much higher than the average
costs for all cases in MS-DRGs 643, 644, and 645. However, after
considering these findings in the context of the current MS-DRG
structure, we stated in the FY 2019 IPPS/LTCH PPS proposed rule that we
were unable to identify an MS-DRG that would more closely parallel
these cases with respect to average costs and length of stay that would
also be clinically aligned. We further stated that our clinical
advisors believe that, in the current MS-DRG structure, the clinical
characteristics of patients in these cases are most closely aligned
with the clinical characteristics of patients in all cases in MS-DRG
642. Moreover, given the small number of porphyria cases, we do not
believe there is justification for creating a new MS-DRG. Basing a new
MS-DRG on such a small number of cases 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. In summary, we did
not propose to revise the MS-DRG classification for porphyria cases.
Comment: Some commenters supported CMS' proposal to maintain
porphyria cases in MS-DRG 642.
Response: We appreciate the commenters' support.
Comment: Other commenters opposed CMS' proposal to not create a new
MS-DRG for cases involving ICD-10-CM diagnosis code E80.21. These
commenters described significant difficulties encountered by patients
with acute porphyria attacks in obtaining Panhematin[supreg] when
presenting to an inpatient hospital, which they attribute to the strong
financial disincentives faced by facilities to treat these cases on an
inpatient basis. The commenters asserted that the inpatient stays
required for management of acute porphyria attacks are not clinically
similar to inpatient stays for other inborn disorders of metabolism
(which comprise the cases assigned to MS-DRG 642). The commenters
stated that, based on the lower than expected average cost per case and
longer than expected length of stay for acute porphyria attacks, it
appears that facilities are frequently not providing Panhematin[supreg]
to patients in this condition, and instead attempting to provide
symptom relief and transferring patients to an outpatient setting to
receive the drug where they can be adequately paid. The commenters
stated that this is in contrast to the standard of care for acute
porphyria attacks and can result in devastating long-term health
consequences. The commenters suggested that CMS consider alternative
mechanisms to ensure adequate payment for cases involving rare
diseases. In summary, commenters asserted that creating a new MS-DRG
would allow more accurate payment for the cases that remain in MS-DRG
642 and facilitate access to the standard of care for patients with
acute porphyria attacks.
Response: We acknowledge the commenters' concerns. As we have
stated in prior rulemaking, it is not appropriate for facilities to
deny treatment to beneficiaries needing a specific type of therapy or
treatment that involves increased costs. The MS-DRG system is a system
of averages and it is expected that across the diagnostic related
groups that within certain groups, some cases may demonstrate higher
than average costs, while other cases may demonstrate lower than
average costs.
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20212 through 20213), we recognize the average costs of the small
number of porphyria cases are greater than the average costs of the
cases in MS-DRG 642 overall. An averaged payment system depends on
aggregation of similar cases with a range of costs, and it is therefore
usually possible to define subsets with higher values and subsets with
lower values. We seek to identify sufficiently large sets of claims
data with a resource/cost similarity and clinical similarity in
developing diagnostic-related groups rather than smaller subsets of
diagnoses. In response to the commenters' assertion that these cases
are not clinically similar to other cases within the MS-DRG, our
clinical advisors continue to believe that MS-DRG 642 represents the
most clinically appropriate placement within the current MS-DRG
structure at this time because the clinical characteristics of patients
in these cases are most closely aligned with the clinical
characteristics of patients in all cases in MS-DRG 642.
We are sensitive to the commenters' concerns about access to
treatment for beneficiaries who have been diagnosed with this
condition. Therefore, as part of our ongoing, comprehensive analysis of
the MS-DRGs under ICD-10, we will continue to explore mechanisms
through which to address rare diseases and low volume DRGs. However, at
this time, for the reasons summarized earlier, we are finalizing our
proposal for FY 2019 to maintain the MS-DRG classification for
porphyria cases.
9. MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract):
Admit for Renal Dialysis
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20213 through 20214),we received a request to review the codes assigned
to MS-DRG 685 (Admit for Renal Dialysis) to determine if the MS-DRG
should be deleted, or if it should remain as a valid MS-DRG. Currently,
the ICD-10-CM diagnosis codes shown in the table below are assigned to
MS-DRG 685:
------------------------------------------------------------------------
ICD-10-CM code ICD-10-CM code title
------------------------------------------------------------------------
Z49.01.................... Encounter for fitting and adjustment of
extracorporeal dialysis catheter.
Z49.02.................... Encounter for fitting and adjustment of
peritoneal dialysis catheter.
Z49.31.................... Encounter for adequacy testing for
hemodialysis.
[[Page 41202]]
Z49.32.................... Encounter for adequacy testing for
peritoneal dialysis.
------------------------------------------------------------------------
The requestor stated that, under ICD-9-CM, diagnosis code V56.0
(Encounter for extracorporeal dialysis) was reported as the principal
diagnosis to identify patients who were admitted for an encounter for
dialysis. However, under ICD-10-CM, there is no comparable code in
which to replicate such a diagnosis. The requestor noted that, while
patients continued to be admitted under inpatient status (under certain
circumstances) for dialysis services, there is no existing ICD-10-CM
diagnosis code within the classification that specifically identifies a
patient being admitted for an encounter for dialysis services.
The requestor also noted that three of the four ICD-10-CM diagnosis
codes currently assigned to MS-DRG 685 are on the ``Unacceptable
Principal Diagnosis'' edit code list in the Medicare Code Editor (MCE).
Therefore, these codes are not allowed to be reported as a principal
diagnosis for an inpatient admission.
We examined claims data from the September 2017 update of the FY
2017 MedPAR file for cases reporting ICD-10-CM diagnosis codes Z49.01,
Z49.02, Z49.31, and Z49.32. Our findings are shown in the following
table.
Admit for Renal Dialysis Encounter
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 685--All cases........................................... 78 4 $8,871
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.01..... 78 4 8,871
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.02..... 0 0 0
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.31..... 0 0 0
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.32..... 0 0 0
----------------------------------------------------------------------------------------------------------------
As shown in the table above, for MS-DRG 685, there were a total of
78 cases reporting ICD-10-CM diagnosis code Z49.01, with an average
length of stay of 4 days and average costs of $8,871. There were no
cases reporting ICD-10-CM diagnosis code Z49.02, Z49.31, or Z49.32.
Our clinical advisors reviewed the clinical issues, as well as the
claims data for MS-DRG 685. Based on their review of the data analysis,
our clinical advisors recommended that MS-DRG 685 be deleted and ICD-
10-CM diagnosis codes Z49.01, Z49.02, Z49.31, and Z49.32 be reassigned.
Historically, patients were admitted as inpatients to receive
hemodialysis services. However, over time, that practice has shifted to
outpatient and ambulatory settings. Because of this change in medical
practice, we stated in the FY 2019 IPPS/LTCH PPS proposed rule that we
did not believe that it was appropriate to maintain a vestigial MS-DRG,
particularly due to the fact that the transition to ICD-10 had resulted
in three out of four codes that mapped to the MS-DRG being precluded
from being used as principal diagnosis codes on the claim. In addition,
our clinical advisors believed that reassigning the ICD-10-CM diagnosis
codes from MS-DRG 685 to MS-DRGs 698, 699, and 700 (Other Kidney and
Urinary Tract Diagnoses with MCC, with CC, and without CC\MCC,
respectively) was clinically appropriate because the reassignment would
result in an accurate MS-DRG assignment of a specific case or inpatient
service and encounter based on acceptable principal diagnosis codes
under these MS-DRGs.
Therefore, for FY 2019, because there is no existing ICD-10-CM
diagnosis code within the classification system that specifically
identifies a patient being admitted for an encounter for dialysis
services; and three of the four ICD-10-CM diagnosis codes, Z49.02,
Z49.31, and Z49.32, currently assigned to MS-DRG 685 are on the
Unacceptable Principal Diagnosis edit code list in the MCE, we proposed
to reassign ICD-10-CM diagnosis codes Z49.01, Z49.02, Z49.31, and
Z49.32 from MS-DRG 685 to MS-DRGs 698, 699, and 700, and to delete MS-
DRG 685.
Comment: Commenters agreed with the proposal to reassign ICD-10-CM
diagnosis codes Z49.01, Z49.02, Z49.31, and Z49.32 from MS-DRG 685 to
MS-DRGs 698, 699, and 700, and to delete MS-DRG 685.
Response: We thank the commenters for their support.
After consideration of the public comments we received, we are
finalizing our proposal to delete MS-DRG 685 and reassign ICD-10-CM
diagnosis codes Z49.01, Z49.02, Z49.31, and Z49.32 from MS-DRG 685 to
MS-DRGs 698, 699, and 700 for FY 2019, without modification.
10. MDC 14 (Pregnancy, Childbirth and the Puerperium)
In the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 19834) and final
rule (82 FR 38036 through 38037), we noted that the MS-DRG logic
involving a vaginal delivery under MDC 14 is technically complex as a
result of the requirements that must be met to satisfy assignment to
the affected MS-DRGs. As a result, we solicited public comments on
further refinement to the following four MS-DRGs related to vaginal
delivery: MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C);
MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except Sterilization
and/or D&C); MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis);
and MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis). In
addition, we sought public comments on further refinements to the
conditions defined as a complicating diagnosis in MS-DRG 774 and MS-DRG
781 (Other Antepartum Diagnoses with Medical Complications). We
indicated that we would review public comments received in response to
the solicitation as we continued to evaluate these MS-DRGs under MDC 14
and, if warranted, we would propose refinements for FY 2019. Commenters
were instructed to direct comments for consideration to the CMS MS-DRG
Classification Change Request Mailbox located at
[email protected] by November 1, 2017.
[[Page 41203]]
In response to our solicitation for public comments on the MS-DRGs
related to vaginal delivery, one commenter recommended that CMS convene
a workgroup that would include hospital staff and physicians to
systematically review the MDC 14 MS-DRGs and to identify which
conditions should appropriately be considered complicating diagnoses.
As an interim step, this commenter recommended that CMS consider the
following suggestions as a result of its own evaluation of MS-DRGs 767,
774 and 775.
For MS-DRG 767, the commenter recommended that the following ICD-
10-CM diagnosis codes and ICD-10-PCS procedure code be removed from the
GROUPER logic and provided the rationale for why the commenter
suggested removing each code.
Suggestions for MS-DRG 767
[Vaginal delivery with sterilization and/or D&C]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 767
------------------------------------------------------------------------
O66.41.................. Failed attempted This code indicates
vaginal birth after that the attempt at
previous cesarean vaginal delivery has
delivery. failed.
O71.00.................. Rupture of uterus This code indicates
before onset of that the uterus has
labor, unspecified ruptured before onset
trimester. of labor and
therefore, a vaginal
delivery would not be
possible.
O82..................... Encounter for cesarean This code indicates
delivery without the encounter is for
indication. a cesarean delivery.
O75.82.................. Onset (spontaneous) of This code indicates
labor after 37 weeks this is a cesarean
of gestation but delivery.
before 39 completed
weeks, with delivery
by (planned) C-
section.
------------------------------------------------------------------------
Suggestions for MS-DRG 767
[Vaginal delivery with sterilization and/or D&C]
------------------------------------------------------------------------
Rationale for removing
ICD-10-PCS code Code description code from MS-DRG 767
------------------------------------------------------------------------
10A07Z6................. Abortion of products This code indicates
of conception, the procedure to be
vacuum, via natural an abortion rather
or artificial opening. than a vaginal
delivery.
------------------------------------------------------------------------
For MS-DRG 774, the commenter recommended that the following ICD-
10-CM diagnosis codes be removed from the GROUPER logic and provided
the rationale for why the commenter suggested removing each code.
Suggestions for MS-DRG 774
[Vaginal delivery with complicating diagnoses]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 774
------------------------------------------------------------------------
O66.41.................. Failed attempted This code indicates
vaginal birth after that the attempt at
previous cesarean vaginal delivery has
delivery. failed.
O71.00.................. Rupture of uterus This code indicates
before onset of that the uterus has
labor, unspecified ruptured before onset
trimester. of labor and
therefore, a vaginal
delivery would not be
possible.
O75.82.................. Onset (spontaneous) of This code indicates
labor after 37 weeks this is a planned
of gestation but cesarean delivery.
before 39 completed
weeks, with delivery
by (planned) C-
section.
O82..................... Encounter for cesarean This code indicates
delivery without the encounter is for
indication. a cesarean delivery.
O80..................... Encounter for full- According to the
term uncomplicated Official Guidelines
delivery. for Coding and
Reporting, ``Code O80
should be assigned
when a woman is
admitted for a full
term normal delivery
and delivers a
single, healthy
infant without any
complications
antepartum, during
the delivery, or
postpartum during the
delivery episode.''
------------------------------------------------------------------------
For MS-DRG 775, the commenter recommended that the following ICD-
10-CM diagnosis codes and ICD-10-PCS procedure code be removed from the
GROUPER logic and provided the rationale for why the commenter
suggested removing each code.
[[Page 41204]]
Suggestions for MS-DRG 775
[Vaginal delivery without complicating diagnoses]
----------------------------------------------------------------------------------------------------------------
Rationale for removing code from MS-DRG
ICD-10-CM code Code description 775
----------------------------------------------------------------------------------------------------------------
O66.41............................ Failed attempted vaginal birth This code indicates that the attempt at
after previous cesarean vaginal delivery has failed.
delivery.
O69.4XX0.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, not applicable vasa previa always results in C-section.
or unspecified. Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O69.4XX2.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, fetus 2. vasa previa always results in C-section.
Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O69.4XX3.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, fetus 3. vasa previa always results in C-section.
Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O69.4XX4.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, fetus 4. vasa previa always results in C-section.
Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O69.4XX5.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, fetus 5. vasa previa always results in C-section.
Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O69.4XX9.......................... Labor and delivery complicated According to the physicians consulted,
by vasa previa, other fetus. vasa previa always results in C-section.
Research indicates that when vasa previa
is diagnosed, C-section before labor
begins can save the baby's life.
O71.00............................ Rupture of uterus before onset This code indicates that the uterus has
of labor, unspecified trimester. ruptured before onset of labor and
therefore, a vaginal delivery would not
be possible.
O82............................... Encounter for cesarean delivery This code indicates the encounter is for a
without indication. cesarean delivery.
----------------------------------------------------------------------------------------------------------------
Suggestions for MS-DRG 775
[Vaginal delivery without complicating diagnoses]
------------------------------------------------------------------------
Rationale for removing
ICD-10-PCS code Code description code from MS-DRG 775
------------------------------------------------------------------------
10A07Z6................. Abortion of Products This code indicates
of Conception, the procedure to be
Vacuum, Via Natural an abortion rather
or Artificial Opening. than a vaginal
delivery.
------------------------------------------------------------------------
Another commenter agreed that the MS-DRG logic for a vaginal
delivery under MDC 14 is technically complex and provided examples to
illustrate these facts. For instance, the commenter noted that the
GROUPER logic code lists appear redundant with several of the same
codes listed for different MS-DRGs and that the GROUPER logic code list
for a vaginal delivery in MS-DRG 774 is comprised of diagnosis codes
while the GROUPER logic code list for a vaginal delivery in MS-DRG 775
is comprised of procedure codes. The commenter also noted that several
of the ICD-10-CM diagnosis codes shown in the table below that became
effective with discharges on and after October 1, 2016 (FY 2017) or
October 1, 2017 (FY 2018) appear to be missing from the GROUPER logic
code lists for MS-DRGs 781 and 774.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
O11.4..................... Pre-existing hypertension with pre-
eclampsia, complicating childbirth.
O11.5..................... Pre-existing hypertension with pre-
eclampsia, complicating the puerperium.
012.04.................... Gestational edema, complicating childbirth.
012.05.................... Gestational edema, complicating the
puerperium.
012.14.................... Gestational proteinuria, complicating
childbirth.
012.15.................... Gestational proteinuria, complicating the
puerperium.
012.24.................... Gestational edema with proteinuria,
complicating childbirth.
012.25.................... Gestational edema with proteinuria,
complicating the puerperium.
O13.4..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating childbirth.
O13.5..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating the puerperium.
O14.04.................... Mild to moderate pre-eclampsia, complicating
childbirth.
O14.05.................... Mild to moderate pre-eclampsia, complicating
the puerperium.
O14.14.................... Severe pre-eclampsia complicating
childbirth.
O14.15.................... Severe pre-eclampsia, complicating the
puerperium.
O14.24.................... HELLP syndrome, complicating childbirth.
O14.25.................... HELLP syndrome, complicating the puerperium.
O14.94.................... Unspecified pre-eclampsia, complicating
childbirth.
O14.95.................... Unspecified pre-eclampsia, complicating the
puerperium.
O15.00.................... Eclampsia complicating pregnancy,
unspecified trimester.
O15.02.................... Eclampsia complicating pregnancy, second
trimester.
[[Page 41205]]
O15.03.................... Eclampsia complicating pregnancy, third
trimester.
O15.1..................... Eclampsia complicating labor.
O15.2..................... Eclampsia complicating puerperium, second
trimester.
O16.4..................... Unspecified maternal hypertension,
complicating childbirth.
O16.5..................... Unspecified maternal hypertension,
complicating the puerperium.
O24.415................... Gestational diabetes mellitus in pregnancy,
controlled by oral hypoglycemic drugs.
O24.425................... Gestational diabetes mellitus in childbirth,
controlled by oral hypoglycemic drugs.
O24.435................... Gestational diabetes mellitus in puerperium,
controlled by oral hypoglycemic drugs.
O44.20.................... Partial placenta previa NOS or without
hemorrhage, unspecified trimester.
O44.21.................... Partial placenta previa NOS or without
hemorrhage, first trimester.
O44.22.................... Partial placenta previa NOS or without
hemorrhage, second trimester.
O44.23.................... Partial placenta previa NOS or without
hemorrhage, third trimester.
O44.30.................... Partial placenta previa with hemorrhage,
unspecified trimester.
O44.31.................... Partial placenta previa with hemorrhage,
first trimester.
O44.32.................... Partial placenta previa with hemorrhage,
second trimester.
O44.33.................... Partial placenta previa with hemorrhage,
third trimester.
O44.40.................... Low lying placenta NOS or without
hemorrhage, unspecified trimester.
O44.41.................... Low lying placenta NOS or without
hemorrhage, first trimester.
O44.42.................... Low lying placenta NOS or without
hemorrhage, second trimester.
O44.43.................... Low lying placenta NOS or without
hemorrhage, third trimester.
O44.50.................... Low lying placenta with hemorrhage,
unspecified trimester.
O44.51.................... Low lying placenta with hemorrhage, first
trimester.
O44.52.................... Low lying placenta with hemorrhage, second
trimester.
O44.53.................... Low lying placenta with hemorrhage, third
trimester.
O70.20.................... Third degree perineal laceration during
delivery, unspecified.
O70.21.................... Third degree perineal laceration during
delivery, IIIa.
O70.22.................... Third degree perineal laceration during
delivery, IIIb.
O70.23.................... Third degree perineal laceration during
delivery, IIIc.
O86.11.................... Cervicitis following delivery.
O86.12.................... Endometritis following delivery.
O86.13.................... Vaginitis following delivery.
O86.19.................... Other infection of genital tract following
delivery.
O86.20.................... Urinary tract infection following delivery,
unspecified.
O86.21.................... Infection of kidney following delivery.
O86.22.................... Infection of bladder following delivery.
O86.29.................... Other urinary tract infection following
delivery.
O86.81.................... Puerperal septic thrombophlebitis.
O86.89.................... Other specified puerperal infections.
------------------------------------------------------------------------
Lastly, the commenter stated that the list of ICD-10-PCS procedure
codes appears comprehensive, but indicated that inpatient coding is not
their expertise. We note that it was not clear which list of procedure
codes the commenter was specifically referencing. The commenter did not
provide a list of any procedure codes for CMS to review or reference a
specific MS-DRG in its comment.
Another commenter expressed concern that ICD-10-PCS procedure codes
10D17Z9 (Manual extraction of products of conception, retained, via
natural or artificial opening) and 10D18Z9 (Manual extraction of
products of conception, retained, via natural or artificial opening
endoscopic) are not assigned to the appropriate MS-DRG. ICD-10-PCS
procedure codes 10D17Z9 and 10D18Z9 describe the manual removal of a
retained placenta and are currently assigned to MS-DRG 767 (Vaginal
Delivery with Sterilization and/or D&C). According to the commenter, a
patient that has a vaginal delivery with manual removal of a retained
placenta is not having a sterilization or D&C procedure. The commenter
noted that, under ICD-9-CM, a vaginal delivery with manual removal of
retained placenta grouped to MS-DRG 774 (Vaginal Delivery with
Complicating Diagnosis) or MS-DRG 775 (Vaginal Delivery without
Complicating Diagnosis). The commenter suggested CMS review these
procedure codes for appropriate MS-DRG assignment under the ICD-10 MS-
DRGs.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20217), we
thanked the commenters and stated that we appreciated the
recommendations and suggestions provided in response to our
solicitation for comments on the GROUPER logic for the MS-DRGs
involving a vaginal delivery or complicating diagnosis under MDC 14.
With regard to the commenter who recommended that we convene a
workgroup that would include hospital staff and physicians to
systematically review the MDC 14 MS-DRGs and to identify which
conditions should appropriately be considered complicating diagnoses,
we noted that we formed an internal workgroup comprised of clinical
advisors that included physicians, coding specialists, and other IPPS
policy staff that assisted in our review of the GROUPER logic for a
vaginal delivery and complicating diagnoses. We indicated that we also
received clinical input from 3M/Health Information Systems (HIS) staff,
which, under contract with CMS, is responsible for updating and
maintaining the GROUPER program. We note that our analysis involved
other MS-DRGs under MDC 14, in addition to those for which we
specifically solicited public comments. As one of the other commenters
correctly pointed out, there is redundancy, with several of the same
codes listed for different MS-DRGs. Below we provide a summary of our
internal analysis with responses to the commenters' recommendations and
suggestions incorporated into the applicable sections. We referred
readers to the ICD-10 MS-DRG Version 35 Definitions Manual located via
the internet on the CMS website at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
[[Page 41206]]
AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-
Final-Rule-Data-
Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
documentation of the GROUPER logic associated with the MDC 14 MS-DRGs
to assist in the review of our discussion that follows.
We started our evaluation of the GROUPER logic for the MS-DRGs
under MDC 14 by first reviewing the current concepts that exist. For
example, there are ``groups'' for cesarean section procedures, vaginal
delivery procedures, and abortions. There also are groups where no
delivery occurs, and lastly, there are groups for after the delivery
occurs, or the ``postpartum'' period. These groups are then further
subdivided based on the presence or absence of complicating conditions
or the presence of another procedure. We examined how we could simplify
some of the older, complex GROUPER logic and remain consistent with the
structure of other ICD-10 MS-DRGs. We identified the following MS-DRGs
for closer review, in addition to MS-DRG 767, MS-DRG 768, MS-DRG 774,
MS-DRG 775 and MS-DRG 781.
------------------------------------------------------------------------
MS-DRG Description
------------------------------------------------------------------------
MS-DRG 765................ Cesarean Section with CC/MCC.
MS-DRG 766................ Cesarean Section without CC/MCC.
MS-DRG 769................ Postpartum and Post Abortion Diagnoses with
O.R. Procedure.
MS-DRG 770................ Abortion with D&C, Aspiration Curettage or
Hysterotomy.
MS-DRG 776................ Postpartum and Post Abortion Diagnoses
without O.R. Procedure.
MS-DRG 777................ Ectopic Pregnancy.
MS-DRG 778................ Threatened Abortion.
MS-DRG 779................ Abortion without D&C.
MS-DRG 780................ False Labor.
MS-DRG 782................ Other Antepartum Diagnoses without Medical
Complications.
------------------------------------------------------------------------
The first issue we reviewed was the GROUPER logic for complicating
conditions (MS-DRGs 774 and 781). Because one of the main objectives in
our transition to the MS-DRGs was to better recognize the severity of
illness of a patient, we believed we could structure the vaginal
delivery and other MDC 14 MS-DRGs in a similar way. Therefore, we began
working with the concept of vaginal delivery ``with MCC, with CC and
without CC/MCC'' to replace the older, ``complicating conditions''
logic.
Next, we compared the additional GROUPER logic that exists between
the vaginal delivery and the cesarean section MS-DRGs (MS-DRGs 765,
766, 767, 774, and 775). Currently, the vaginal delivery MS-DRGs take
into account a sterilization procedure; however, the cesarean section
MS-DRGs do not. Because a patient can have a sterilization procedure
performed along with a cesarean section procedure, we adopted a working
concept of ``cesarean section with and without sterilization with MCC,
with CC and without CC/MCC'', as well as ``vaginal delivery with and
without sterilization with MCC, with CC and without CC/MCC''.
We then reviewed the GROUPER logic for the MS-DRGs involving
abortion and where no delivery occurs (MS-DRGs 770, 777, 778, 779, 780,
and 782). We believed that we could consolidate the groups in which no
delivery occurs.
Finally, we considered the GROUPER logic for the MS-DRGs related to
the postpartum period (MS-DRGs 769 and 776) and determined that the
structure of these MS-DRGs did not appear to require modification.
After we established those initial working concepts for the MS-DRGs
discussed above, we examined the list of the ICD-10-PCS procedure codes
that comprise the sterilization procedure GROUPER logic for the vaginal
delivery MS-DRG 767. We identified the two manual extraction of
placenta codes that the commenter had brought to our attention (ICD-10-
PCS codes 10D17Z9 and 10D18Z9). We also identified two additional
procedure codes, ICD-10-PCS codes 10D17ZZ (Extraction of products of
conception, retained, via natural or artificial opening) and 10D18ZZ
(Extraction of products of conception, retained, via natural or
artificial opening endoscopic) in the list that are not sterilization
procedures. Two of the four procedure codes describe manual extraction
(removal) of retained placenta and the other two procedure codes
describe dilation and curettage procedures. We then identified four
more procedure codes in the list that do not describe sterilization
procedures. ICD-10-PCS procedure codes 0UDB7ZX (Extraction of
endometrium, via natural or artificial opening, diagnostic), 0UDB7ZZ
(Extraction of endometrium, via natural or artificial opening), 0UDB8ZX
(Extraction of endometrium, via natural or artificial opening
endoscopic, diagnostic), and 0UDB8ZZ (Extraction of endometrium, via
natural or artificial opening endoscopic) describe dilation and
curettage procedures that can be performed for diagnostic or
therapeutic purposes. We stated in the proposed rule that we believe
that these ICD-10-PCS procedure codes would be more appropriately
assigned to MDC 13 (Diseases and Disorders of the Female Reproductive
System) in MS-DRGs 744 and 745 (D&C, Conization, Laparaoscopy and Tubal
Interruption with and without CC/MCC, respectively) and, therefore,
removed them from our working list of sterilization and/or D&C
procedures. Because the GROUPER logic for MS-DRG 767 includes both
sterilization and/or D&C, we agreed that all the other procedure codes
currently included under that logic list of sterilization procedures
should remain, with the exception of the two identified by the
commenter. Therefore, in the proposed rule, we stated we agreed with
the commenter that the manual extraction of retained placenta procedure
codes should be reassigned to a more clinically appropriate vaginal
delivery MS-DRG because they are not describing sterilization
procedures.
Our attention then turned to other MDC 14 GROUPER logic code lists
starting with the ``CC for C-section'' list under MS-DRGs 765 and 766
(Cesarean Section with and without CC/MCC, respectively). As noted in
the proposed rule and earlier in this section, in conducting our
review, we considered how we could utilize the severity level concept
(with MCC, with CC, and without CC/MCC) where applicable. Consistent
with this approach, we removed the ``CC for C-section'' logic from
these MS-DRGs as part of our working concept and efforts to refine MDC
14. We determined it would be less complicated to simply allow the
existing ICD-10 MS-DRG CC and MCC
[[Page 41207]]
code list logic to apply for these MS-DRGs. Next, we reviewed the logic
code lists for ``Malpresentation'' and ``Twins'' and concluded that
this logic was not necessary for the cesarean section MS-DRGs because
these are describing antepartum conditions and it is the procedure of
the cesarean section that determines whether or not a patient would be
classified to these MS-DRGs. Therefore, those code lists were also
removed for purposes of our working concept. With regard to the
``Operating Room Procedure'' code list, we stated in the proposed rule
that we agreed there should be no changes. However, we noted that the
title to ICD-10-PCS procedure code 10D00Z0 (Extraction of products of
conception, classical, open approach) is being revised, effective
October 1, 2018, to replace the term ``classical'' with ``high'' and
ICD-10-PCS procedure code 10D00Z1 (Extraction of products of
conception, low cervical, open approach) is being revised to replace
the term ``low cervical'' to ``low''. These revisions are also shown in
Table 6F--Revised Procedure Code Titles associated with the proposed
rule and this final rule available via the internet on the CMS website
at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
Next, we reviewed the ``Delivery Procedure'' and ``Delivery
Outcome'' GROUPER logic code lists for the vaginal delivery MS-DRGs
767, 768, 774, and 775. We identified ICD-10-PCS procedure code 10A0726
(Abortion of products of conception, vacuum, via natural or artificial
opening) and ICD-10-PCS procedure code 10S07ZZ (Reposition products of
conception, via natural or artificial opening) under the ``Delivery
Procedure'' code list as procedure codes that should not be included
because ICD-10-PCS procedure code 10A07Z6 describes an abortion
procedure and ICD-10-PCS procedure code 10S07ZZ describes repositioning
of the fetus and does not indicate a delivery took place. We also noted
that, as described in the proposed rule and earlier in this discussion,
a commenter recommended that ICD-10-PCS procedure code 10A07Z6 be
removed from the GROUPER logic specifically for MS-DRGs 767 and 775.
Therefore, we removed these two procedure codes from the logic code
list for ``Delivery Procedure'' in MS-DRGs 767, 768, 774, and 775. We
stated in the proposed rule that we agreed with the commenter that ICD-
10-PCS procedure code 10A07Z6 would be more appropriately assigned to
one of the Abortion MS-DRGs. For the remaining procedures currently
included in the ``Delivery Procedure'' code list we considered which
procedures would be expected to be performed during the course of a
standard, uncomplicated delivery episode versus those that would
reasonably be expected to require additional resources outside of the
delivery room. The list of procedure codes we reviewed is shown in the
following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DQP7ZZ................... Repair rectum, via natural or artificial
opening.
0DQQ0ZZ................... Repair anus, open approach.
0DQQ3ZZ................... Repair anus, percutaneous approach.
0DQQ4ZZ................... Repair anus, percutaneous endoscopic
approach.
0DQQ7ZZ................... Repair anus, via natural or artificial
opening.
0DQQ8ZZ................... Repair anus, via natural or artificial
opening endoscopic.
0DQR0ZZ................... Repair anal sphincter, open approach.
0DQR3ZZ................... Repair anal sphincter, percutaneous
approach.
0DQR4ZZ................... Repair anal sphincter, percutaneous
endoscopic approach.
------------------------------------------------------------------------
While we acknowledged that these procedures may be performed to
treat obstetrical lacerations as discussed in prior rulemaking (81 FR
56853), we stated that we also believe that these procedures would
reasonably be expected to require a separate operative episode and
would not be performed immediately at the time of the delivery.
Therefore, we removed those procedure codes describing repair of the
rectum, anus, and anal sphincter shown in the table above from our
working concept list of procedures to consider for a vaginal delivery.
Our review of the list of diagnosis codes for the ``Delivery Outcome''
as a secondary diagnosis did not prompt any changes. We stated in the
proposed rule we agreed that the current list of diagnosis codes
continues to appear appropriate for describing the outcome of a
delivery.
As the purpose of our analysis and this review was to clarify what
constitutes a vaginal delivery to satisfy the ICD-10 MS-DRG logic for
the vaginal delivery MS-DRGs, we believed it was appropriate to expect
that a procedure code describing the vaginal delivery or extraction of
``products of conception'' procedure and a diagnosis code describing
the delivery outcome should be reported on every claim in which a
vaginal delivery occurs. This is also consistent with Section
I.C.15.b.5 of the ICD-10-CM Official Guidelines for Coding and
Reporting, which states ``A code from category Z37, Outcome of
delivery, should be included on every maternal record when a delivery
has occurred. These codes are not to be used on subsequent records or
on the newborn record.'' Therefore, we adopted the working concept
that, regardless of the principal diagnosis, if there is a procedure
code describing the vaginal delivery or extraction of ``products of
conception'' procedure and a diagnosis code describing the delivery
outcome, this logic would result in assignment to a vaginal delivery
MS-DRG. In the proposed rule, we noted that, as a result of this
working concept, there would no longer be a need to maintain the
``third condition'' list under MS-DRG 774. In addition, as noted in the
proposed rule and earlier in this discussion, because we were working
with the concept of vaginal delivery ``with MCC, with CC, and without
CC/MCC'' to replace the older, ``complicating conditions'' logic, there
would no longer be a need to maintain the ``second condition'' list of
complicating diagnosis under MS-DRG 774.
We then reviewed the GROUPER logic code list of ``Or Other O.R.
procedures'' (MS-DRG 768) to determine if any changes to these lists
were warranted. Similar to our analysis of the procedures listed under
the ``Delivery Procedure'' logic code list, our examination of the
procedures currently described in the ``Or Other O.R. procedures''
procedure code list also considered which procedures would be expected
to be
[[Page 41208]]
performed during the course of a standard, uncomplicated delivery
episode versus those that would reasonably be expected to require
additional resources outside of the delivery room. Our analysis of all
the procedures resulted in the working concept to allow all O.R.
procedures to be applicable for assignment to MS-DRG 768, with the
exception of the procedure codes for sterilization and/or D&C and ICD-
10-PCS procedure codes 0KQM0ZZ (Repair perineum muscle, open approach)
and 0UJM0ZZ (Inspection of vulva, open approach), which we determined
would be reasonably expected to be performed during a standard delivery
episode and, therefore, assigned to MS-DRG 774 or MS-DRG 775. We also
noted that, this working concept for MS-DRG 768 would eliminate vaginal
delivery cases with an O.R. procedure grouping to the unrelated MS-DRGs
because all O.R. procedures would be included in the GROUPER logic
procedure code list for ``Or Other O.R. Procedures''.
The next set of MS-DRGs we examined more closely included MS-DRGs
777, 778, 780, 781, and 782. We believed that, because the conditions
in these MS-DRGs are all describing antepartum related conditions, we
could group the conditions together clinically. Diagnoses described as
occurring during pregnancy and diagnoses specifying a trimester or
maternal care in the absence of a delivery procedure reported were
considered antepartum conditions. We also believed we could better
classify these groups of patients based on the presence or absence of a
procedure. Therefore, we worked with the concept of ``antepartum
diagnoses with and without O.R. procedure''.
As noted in the proposed rule and earlier in the discussion, we
adopted a working concept of ``cesarean section with and without
sterilization with MCC, with CC, and without CC/MCC.'' This concept is
illustrated in the following table and includes our suggested
modifications.
Suggested Modifications to MS-DRGs for MDC 14
[Pregnancy, childbirth and the puerperium]
------------------------------------------------------------------------
-------------------------------------------------------------------------
DELETE 2 MS-DRGs:
MS-DRG 765 (Cesarean Section with CC/MCC).
MS-DRG 766 (Cesarean Section without CC/MCC).
CREATE 6 MS-DRGs:
MS-DRG XXX (Cesarean Section with Sterilization with MCC).
MS-DRG XXX (Cesarean Section with Sterilization with CC).
MS-DRG XXX (Cesarean Section with Sterilization without CC/MCC).
MS-DRG XXX (Cesarean Section without Sterilization with MCC).
MS-DRG XXX (Cesarean Section without Sterilization with CC).
MS-DRG XXX (Cesarean Section without Sterilization without CC/MCC).
------------------------------------------------------------------------
As shown in the table, we suggested deleting MS-DRGs 765 and 766.
We also suggested creating 6 new MS-DRGs that are subdivided by a 3-way
severity level split that includes ``with Sterilization'' and ``without
Sterilization''.
We also adopted a working concept of ``vaginal delivery with and
without sterilization with MCC, with CC, and without CC/MCC''. This
concept is illustrated in the following table and includes our
suggested modifications.
Suggested Modifications to MS-DRGs for MDC 14
[Pregnancy, childbirth and the puerperium]
------------------------------------------------------------------------
-------------------------------------------------------------------------
DELETE 3 MS-DRGs:
MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C).
MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis).
MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis).
CREATE 6 MS-DRGs:
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C with MCC).
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C with CC).
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C without CC/MCC).
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C with MCC).
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C with CC).
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C without CC/
MCC).
------------------------------------------------------------------------
As shown in the table, we suggested deleting MS-DRGs 767, 774, and
775. We also suggested creating 6 new MS-DRGs that are subdivided by a
3-way severity level split that includes ``with Sterilization/D&C'' and
``without Sterilization/D&C''.
In addition, as indicated above, we believed that we could
consolidate the groups in which no delivery occurs. In the proposed
rule, we stated we believe that consolidating MS-DRGs where clinically
coherent conditions exist is consistent with our approach to MS-DRG
reclassification and our continued refinement efforts. This concept is
illustrated in the following table and includes our suggested
modifications.
Suggested Modifications to MS-DRGs for MDC 14
[Pregnancy, childbirth and the puerperium]
------------------------------------------------------------------------
-------------------------------------------------------------------------
DELETE 5 MS-DRGs:
MS-DRG 777 (Ectopic Pregnancy).
MS-DRG 778 (Threatened Abortion).
MS-DRG 780 (False Labor).
MS-DRG 781 (Other Antepartum Diagnoses with Medical Complications).
MS-DRG 782 (Other Antepartum Diagnoses without Medical Complications).
CREATE 6 MS-DRGs:
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure with MCC).
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure with CC).
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure without CC/
MCC).
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure with
MCC).
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure with
CC).
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure without
CC/MCC).
------------------------------------------------------------------------
As shown in the table, we suggested deleting MS-DRGs 777, 778, 780,
781, and 782. We also suggested creating 6 new MS-DRGs that are
subdivided by a 3-way severity level split that includes ``with O.R.
Procedure'' and ``without O.R. Procedure''.
Once we established each of these fundamental concepts from a
clinical perspective, we were able to analyze the data to determine if
our initial suggested modifications were supported.
To analyze our suggested modifications for the cesarean section and
vaginal delivery MS-DRGs, we examined the claims data from the
September 2017 update of the FY 2017 MedPAR file for MS-DRGs 765, 766,
767, 768, 774, and 775.
MS-DRGs for MDC 14 Pregnancy, Childbirth and the Puerperium
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 765 (Cesarean Section with CC/MCC)--All cases............ 3,494 4.6 $8,929
MS-DRG 766 (Cesarean Section without CC/MCC)--All cases......... 1,974 3.1 6,488
MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C)--All 351 3.2 7,886
cases..........................................................
MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except 17 6.2 26,164
Sterilization and/or D&C)--All cases...........................
[[Page 41209]]
MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis)--All 1,650 3.3 6,046
cases..........................................................
MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis)-- 4,676 2.4 4,769
All cases......................................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 3,494 cases in MS-DRG
765, with an average length of stay of 4.6 days and average costs of
$8,929. For MS-DRG 766, there were a total of 1,974 cases, with an
average length of stay of 3.1 days and average costs of $6,488. For MS-
DRG 767, there were a total of 351 cases, with an average length of
stay of 3.2 days and average costs of $ 7,886. For MS-DRG 768, there
were a total of 17 cases, with an average length of stay of 6.2 days
and average costs of $26,164. For MS-DRG 774, there were a total of
1,650 cases, with an average length of stay of 3.3 days and average
costs of $6,046. Lastly, for MS-DRG 775, there were a total of 4,676
cases, with an average length of stay of 2.4 days and average costs of
$4,769.
To compare and analyze the impact of our suggested modifications,
we ran a simulation using the Version 35 ICD-10 MS-DRG GROUPER. The
following table reflects our findings for the suggested Cesarean
Section MS-DRGs with a 3-way severity level split.
Suggested MS-DRGs for Cesarean Section
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 783 (Cesarean Section with Sterilization with MCC)....... 178 6.4 $12,977
MS-DRG 784 (Cesarean Section with Sterilization with CC)........ 511 4.1 8,042
MS-DRG 785 (Cesarean Section with Sterilization without CC/MCC). 475 3.0 6,259
MS-DRG 786 (Cesarean Section without Sterilization with MCC).... 707 5.9 11,515
MS-DRG 787 (Cesarean Section without Sterilization with CC)..... 1,887 4.2 7,990
MS-DRG 788 (Cesarean Section without Sterilization without CC/ 1,710 3.3 6,663
MCC)...........................................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 178 cases for the
cesarean section with sterilization with MCC group, with an average
length of stay of 6.4 days and average costs of $12,977. There were a
total of 511 cases for the cesarean section with sterilization with CC
group, with an average length of stay of 4.1 days and average costs of
$8,042. There were a total of 475 cases for the cesarean section with
sterilization without CC/MCC group, with an average length of stay of
3.0 days and average costs of $6,259. For the cesarean section without
sterilization with MCC group there were a total of 707 cases, with an
average length of stay of 5.9 days and average costs of $11,515. There
were a total of 1,887 cases for the cesarean section without
sterilization with CC group, with an average length of stay of 4.2 days
and average costs of $7,990. Lastly, there were a total of 1,710 cases
for the cesarean section without sterilization without CC/MCC group,
with an average length of stay of 3.3 days and average costs of $6,663.
The following table reflects our findings for the suggested Vaginal
Delivery MS-DRGs with a 3-way severity level split.
Suggested MS-DRGs for Vaginal Delivery
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 796 (Vaginal Delivery with Sterilization/D&C with MCC)... 25 6.7 $11,421
MS-DRG 797 (Vaginal Delivery with Sterilization/D&C with CC).... 63 2.4 6,065
MS-DRG 798 (Vaginal Delivery with Sterilization/D&C without CC/ 126 2.3 6,697
MCC)...........................................................
MS-DRG 805 (Vaginal Delivery without Sterilization/D&C with MCC) 406 5.0 9,605
MS-DRG 806 (Vaginal Delivery without Sterilization/D&C with CC). 1,952 2.9 5,506
MS-DRG 807 (Vaginal Delivery without Sterilization/D&C without 4,105 2.3 4,601
CC/MCC)........................................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 25 cases for the
vaginal delivery with sterilization/D&C with MCC group, with an average
length of stay of 6.7 days and average costs of $11,421. There were a
total of 63 cases for the vaginal delivery with sterilization/D&C with
CC group, with an average length of stay of 2.4 days and average costs
of $6,065. There were a total of 126 cases for vaginal delivery with
sterilization/D&C without CC/MCC group, with an average length of stay
of 2.3 days and average costs of $6,697. There were a total of 406
cases for the vaginal delivery without sterilization/D&C with MCC
group, with an average length of stay of 5.0 days and average costs of
$9,605. There were a total of 1,952 cases for the vaginal delivery
without sterilization/D&C with CC group, with an average length of stay
of 2.9 days and average costs of $5,506. There were a total of 4,105
cases for the vaginal delivery without sterilization/D&C without CC/MCC
group, with an average length of stay of 2.3 days and average costs of
$4,601.
We then reviewed the claims data from the September 2017 update of
the FY 2017 MedPAR file for MS-DRGs 777, 778, 780, 781, and 782. Our
findings are shown in the following table.
[[Page 41210]]
MS-DRGs for MDC 14 Pregnancy, Childbirth and the Puerperium
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 777 (Ectopic Pregnancy)--All cases....................... 72 1.9 $7,149
MS-DRG 778 (Threatened Abortion)--All cases..................... 205 2.7 4,001
MS-DRG 780 (False Labor)--All cases............................. 41 2.1 3,045
MS-DRG 781 (Other Antepartum Diagnoses with Medical 2,333 3.7 5,817
Complications)--All cases......................................
MS-DRG 782 (Other Antepartum Diagnoses without Medical 70 2.1 3,381
Complications)--All cases......................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 72 cases in MS-DRG
777, with an average length of stay of 1.9 days and average costs of
$7,149. For MS-DRG 778, there were a total of 205 cases, with an
average length of stay of 2.7 days and average costs of $4,001. For MS-
DRG 780, there were a total of 41 cases, with an average length of stay
of 2.1 days and average costs of $3,045. For MS-DRG 781, there were a
total of 2,333 cases, with an average length of stay of 3.7 days and
average costs of $5,817. Lastly, for MS-DRG 782, there were a total of
70 cases, with an average length of stay of 2.1 days and average costs
of $3,381.
To compare and analyze the impact of deleting those 5 MS-DRGs and
creating 6 new MS-DRGs, we ran a simulation using the Version 35 ICD-10
MS-DRG GROUPER. Our findings below represent what we found and would
expect under the suggested modifications. The following table reflects
the MS-DRGs for the suggested Other Antepartum Diagnoses MS-DRGs with a
3-way severity level split.
Suggested MS-DRGs for Other Antepartum Diagnoses
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 817 (Other Antepartum Diagnoses with O.R. Procedure with 60 5.1 $13,117
MCC)...........................................................
MS-DRG 818 (Other Antepartum Diagnoses with O.R. Procedure with 66 4.2 10,483
CC)............................................................
MS-DRG 819 (Other Antepartum Diagnoses with O.R. Procedure 44 1.7 5,904
without CC/MCC)................................................
MS-DRG 831 (Other Antepartum Diagnoses without O.R. Procedure 786 4.3 7,248
with MCC)......................................................
MS-DRG 832 (Other Antepartum Diagnoses without O.R. Procedure 910 3.5 4,994
with CC).......................................................
MS-DRG 833 (Other Antepartum Diagnoses without O.R. Procedure 855 2.7 3,843
without CC/MCC)................................................
----------------------------------------------------------------------------------------------------------------
Our analysis of claims data from the September 2017 update of the
FY 2017 MedPAR file recognized that when the criteria to create
subgroups were applied for the 3-way severity level splits for the
suggested MS-DRGs, those criteria were not met in all instances. For
example, the criteria that there are at least 500 cases in the MCC or
CC group was not met for the suggested Vaginal Delivery with
Sterilization/D&C 3-way severity level split or the suggested Other
Antepartum Diagnoses with O.R. Procedure 3-way severity level split.
However, as we have noted in prior rulemaking (72 FR 47152), we
cannot adopt the same approach to refine the maternity and newborn MS-
DRGs because of the extremely low volume of Medicare patients there are
in these DRGs. While there is not a high volume of these cases
represented in the Medicare data, and while we generally advise that
other payers should develop MS-DRGs to address the needs of their
patients, we believe that our suggested 3-way severity level splits
would address the complexity of the current MDC 14 GROUPER logic for a
vaginal delivery and takes into account the new and different clinical
concepts that exist under ICD-10 for this subset of patients while also
maintaining the existing MS-DRG structure for identifying severity of
illness, utilization of resources and complexity of service.
However, as an alternative option, we also performed analysis for a
2-way severity level split for the suggested MS-DRGs. Our findings are
shown in the following tables.
Suggested MS-DRGs for Cesarean Section
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Cesarean Section with Sterilization with CC/MCC).... 689 4.7 $9,317
MS-DRG XXX (Cesarean Section with Sterilization without CC/MCC). 475 3.0 6,259
MS-DRG XXX (Cesarean Section without Sterilization with MCC).... 2,594 4.7 8,951
MS-DRG XXX (Cesarean Section without Sterilization without CC/ 1,710 3.3 6,663
MCC)...........................................................
----------------------------------------------------------------------------------------------------------------
Suggested MS-DRGs for Vaginal Delivery
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C with CC/MCC) 88 3.6 $7,586
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C without CC/ 126 2.3 6,697
MCC)...........................................................
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C with MCC) 2,358 3.2 6,212
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C without 4,105 2.3 4,601
CC/MCC)........................................................
----------------------------------------------------------------------------------------------------------------
[[Page 41211]]
Suggested MS-DRGs for Other Antepartum Diagnoses
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure with 126 4.7 $11,737
MCC)...........................................................
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure 44 1.7 5,904
without CC/MCC)................................................
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure 1,696 3.9 6,039
with MCC)......................................................
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure 855 2.7 3,843
without CC/MCC)................................................
----------------------------------------------------------------------------------------------------------------
Similar to the analysis performed for the 3-way severity level
split, we acknowledged that when the criteria to create subgroups was
applied for the alternative 2-way severity level splits for the
suggested MS-DRGs, those criteria were not met in all instances. For
example, the suggested Vaginal Delivery with Sterilization/D&C and the
Other Antepartum Diagnoses with O.R. Procedure alternative option 2-way
severity level splits did not meet the criteria for 500 or more cases
in the MCC or CC group.
Based on our review, which included support from our clinical
advisors, and the analysis of claims data described above, in the FY
2019 IPPS/LTCH PPS proposed rule, we proposed the deletion of 10 MS-
DRGs and the creation of 18 new MS-DRGs (as shown below). This proposal
was based on the approach described above, which involves consolidating
specific conditions and concepts into the structure of existing logic
and making additional modifications, such as adding severity levels, as
part of our refinement efforts for the ICD-10 MS-DRGs. We indicated in
the proposed rule that our proposals are intended to address the
vaginal delivery ``complicating diagnosis'' logic and antepartum
diagnoses with ``medical complications'' logic with the proposed
addition of the existing and familiar severity level concept (with MCC,
with CC, and without CC/MCC) to the MDC 14 MS-DRGs to provide the
ability to distinguish the varying resource requirements for this
subset of patients and allow the opportunity to make more meaningful
comparisons with regard to severity across the MS-DRGs. We stated that
our proposals, as set forth below, would also simplify the vaginal
delivery procedure logic that we identified and commenters acknowledged
as technically complex by eliminating the extensive diagnosis and
procedure code lists for several conditions that must be met for
assignment to the vaginal delivery MS-DRGs. We stated that our
proposals also are intended to respond to issues identified and brought
to our attention through public comments for consideration in updating
the GROUPER logic code lists in MDC 14.
Specifically, we proposed to delete the following 10 MS-DRGs under
MDC 14:
MS-DRG 765 (Cesarean Section with CC/MCC);
MS-DRG 766 (Cesarean Section without CC/MCC);
MS-DRG 767 (Vaginal Delivery with Sterilization and/or
D&C);
MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis);
MS-DRG 775 (Vaginal Delivery without Complicating
Diagnosis);
MS-DRG 777 (Ectopic Pregnancy);
MS-DRG 778 (Threatened Abortion);
MS-DRG 780 (False Labor);
MS-DRG 781 (Other Antepartum Diagnoses with Medical
Complications); and
MS-DRG 782 (Other Antepartum Diagnoses without Medical
Complications).
We proposed to create the following new 18 MS-DRGs under MDC 14:
Proposed new MS-DRG 783 (Cesarean Section with
Sterilization with MCC);
Proposed new MS-DRG 784 (Cesarean Section with
Sterilization with CC);
Proposed new MS-DRG 785 (Cesarean Section with
Sterilization without CC/MCC);
Proposed new MS-DRG 786 (Cesarean Section without
Sterilization with MCC);
Proposed new MS-DRG 787 (Cesarean Section without
Sterilization with CC);
Proposed new MS-DRG 788 Cesarean Section without
Sterilization without CC/MCC);
Proposed new MS-DRG 796 (Vaginal Delivery with
Sterilization/D&C with MCC);
Proposed new MS-DRG 797 (Vaginal Delivery with
Sterilization/D&C with CC);
Proposed new MS-DRG 798 (Vaginal Delivery with
Sterilization/D&C without CC/MCC);
Proposed new MS-DRG 805 (Vaginal Delivery without
Sterilization/D&C with MCC);
Proposed new MS-DRG 806 (Vaginal Delivery without
Sterilization/D&C with CC);
Proposed new MS-DRG 807 (Vaginal Delivery without
Sterilization/D&C without CC/MCC);
Proposed new MS-DRG 817 (Other Antepartum Diagnoses with
O.R. Procedure with MCC);
Proposed new MS-DRG 818 (Other Antepartum Diagnoses with
O.R. Procedure with CC);
Proposed new MS-DRG 819 (Other Antepartum Diagnoses with
O.R. Procedure without CC/MCC);
Proposed new MS-DRG 831 (Other Antepartum Diagnoses
without O.R. Procedure with MCC);
Proposed new MS-DRG 832 (Other Antepartum Diagnoses
without O.R. Procedure with CC); and
Proposed new MS-DRG 833 (Other Antepartum Diagnoses
without O.R. Procedure without CC/MCC).
The diagrams below illustrate how the proposed MS-DRG logic for MDC
14 would function. The first diagram (Diagram 1.) begins by asking if
there is a principal diagnosis from MDC 14. If no, the GROUPER logic
directs the case to the appropriate MDC based on the principal
diagnosis reported. Next, the logic asks if there is a cesarean section
procedure reported on the claim. If yes, the logic asks if there was a
sterilization procedure reported on the claim. If yes, the logic
assigns the case to one of the proposed new MS-DRGs 783, 784, or 785.
If no, the logic assigns the case to one of the proposed new MS-DRGs
786, 787, or 788. If there was not a cesarean section procedure
reported on the claim, the logic asks if there was a vaginal delivery
procedure reported on the claim. If yes, the logic asks if there was
another O.R. procedure other than sterilization, D&C, delivery
procedure or a delivery inclusive O.R. procedure. If yes, the logic
assigns the case to existing MS-DRG 768. If no, the logic asks if there
was a sterilization and/or D&C reported on the claim. If yes, the logic
assigns the case to one of the proposed new MS-DRGs 796, 797, or 798.
If no, the logic assigns the case to one of the proposed new MS-DRGs
805, 806, or 807. If there was not a vaginal delivery procedure
reported on the claim, the GROUPER logic directs you to the other
[[Page 41212]]
non-delivery MS-DRGs as shown in Diagram 2.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR17AU18.000
The logic for Diagram 2. begins by asking if there is a principal
diagnosis of abortion reported on the claim. If yes, the logic then
asks if there was a D&C, aspiration curettage or hysterotomy procedure
reported on the claim. If yes, the logic assigns the case to existing
MS-DRG 770. If no, the logic assigns the case to existing MS-DRG 779.
If there was not a principal diagnosis of abortion reported on the
claim, the logic asks if there was a principal diagnosis of an
antepartum condition reported on the claim. If yes, the logic then asks
if there was an O.R. procedure reported on the claim. If yes, the logic
assigns the case to one of the proposed new MS-DRGs 817, 818, or 819.
If no, the logic assigns the case to one of the proposed new MS-DRGs
831, 832, or 833. If there was not a principal diagnosis of an
antepartum condition reported on the claim, the logic asks if there was
a principal diagnosis of a postpartum condition reported on the claim.
If yes, the logic then asks if there was an O.R. procedure reported on
the claim. If yes, the logic assigns the case to existing MS-DRG 769.
If no, the logic assigns the case to existing MS-DRG 776. If there was
not a principal diagnosis of a postpartum condition reported on the
claim, the logic identifies that there was a principal diagnosis
describing childbirth, delivery or an intrapartum condition reported on
the claim without
[[Page 41213]]
any other procedures, and assigns the case to existing MS-DRG 998
(Principal Diagnosis Invalid as Discharge Diagnosis).
To assist in detecting coding and MS-DRG assignment errors for MS-
DRG 998 that could result when a provider does not report the procedure
code for either a cesarean section or a vaginal delivery along with an
outcome of delivery diagnosis code, as discussed in section II.F.13.d.,
we proposed to add a new Questionable Obstetric Admission edit under
the MCE. We invited public comments on this proposed MCE edit and we
also invited public comments on the need for any additional MCE
considerations with regard to the proposed changes for the MDC 14 MS-
DRGs.
[GRAPHIC] [TIFF OMITTED] TR17AU18.001
BILLING CODE 4120-01-C
We referred readers to Tables 6P.1h. through 6P.1k. associated with
the proposed rule for the lists of the diagnosis and procedure codes
that we proposed to assign to the GROUPER logic for the proposed new
MS-DRGs and the existing MS-DRGs under MDC 14. We invited public
comments on our proposed list of diagnosis codes, which also addresses
the list of diagnosis codes that a commenter identified as missing from
the GROUPER logic. We noted that, as a result of our proposed GROUPER
logic changes to the vaginal delivery MS-DRGs, which would only take
into account the procedure codes for a vaginal delivery and the outcome
of delivery secondary diagnosis codes, there is no longer a need to
maintain a specific principal diagnosis logic list for those MS-DRGs.
Therefore, while we
[[Page 41214]]
appreciate the detailed suggestions and rationale submitted by the
commenter for why specific diagnosis codes should be removed from the
vaginal delivery principal diagnosis logic as displayed earlier in this
discussion, we proposed to remove that logic. We invited public
comments on this proposal, as well as our proposed list of procedure
codes for the proposed revised MDC 14 MS-DRG logic, which would require
a procedure code for case assignment. We also invited public comments
on the proposed deletion of the 10 MS-DRGs and the proposed creation of
18 new MS-DRGs with a 3-way severity level split listed above in this
section, as well as on the potential alternative new MS-DRGs using a 2-
way severity level split as also presented above.
Comment: Commenters agreed with CMS' proposal to restructure the
MS-DRGs within MDC 14. A few commenters commended CMS on the proposed
new structure and GROUPER logic for these MS-DRGs, and believed that
the new structure and logic is clearer and clinically appropriate.
Another commenter agreed with the proposed new GROUPER logic for MDC 14
for deliveries with the 3-way severity level splits. The commenters
anticipated that the new structure and logic will provide more clarity
than the current structure.
Response: We appreciate the commenters' support. We agree the
proposed new structure and GROUPER logic of the MS-DRGs under MDC 14
will provide more clarity than the current structure and logic.
Comment: Another commenter stated that all of the diagnoses
currently assigned to MS-DRG 774 (Vaginal Delivery with Complicating
Diagnosis) in the GROUPER logic, along with some of the diagnoses that
were noted to appear to be missing from the GROUPER logic (83 FR 20216
through 20217), should be added to the Principal Diagnosis Is Its Own
CC Or MCC logic for the proposed new vaginal delivery MS-DRGs 796
(Vaginal Delivery with Sterilization/D&C with MCC), 797 (Vaginal
Delivery with Sterilization/D&C with CC), 798 (Vaginal Delivery with
Sterilization/D&C without CC/MCC), 805 (Vaginal Delivery without
Sterilization/D&C with MCC), 806 (Vaginal Delivery without
Sterilization/D&C with CC), and 807 (Vaginal Delivery without
Sterilization/D&C without CC/MCC). The commenter provided the following
list of diagnosis codes that were noted to appear to be missing from
the GROUPER logic, and requested CMS consider adding these diagnosis
codes to the Principal Diagnosis Is Its Own CC Or MCC Lists. The
commenter believed that the current GROUPER logic for MS-DRG 774
includes diagnoses that could change the MS-DRG assignment of a case
from MS-DRG 775 to MS-DRG 774 based on the principal diagnosis. The
commenter further expressed concern that these same diagnoses may group
to the proposed new MS-DRGs 798 or 807 (without CC/MCC) under the
proposed new structure and GROUPER logic for the vaginal delivery MS-
DRGs.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
O11.5..................... Pre-existing hypertension with pre-
eclampsia, complicating the puerperium.
012.04.................... Gestational edema, complicating childbirth.
012.05.................... Gestational edema, complicating the
puerperium.
012.14.................... Gestational proteinuria, complicating
childbirth.
012.15.................... Gestational proteinuria, complicating the
puerperium.
012.24.................... Gestational edema with proteinuria,
complicating childbirth.
012.25.................... Gestational edema with proteinuria,
complicating the puerperium.
O13.4..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating childbirth.
O13.5..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating the puerperium.
O14.04.................... Mild to moderate pre-eclampsia, complicating
childbirth.
O14.05.................... Mild to moderate pre-eclampsia, complicating
the puerperium.
O14.14.................... Severe pre-eclampsia complicating
childbirth.
O14.15.................... Severe pre-eclampsia, complicating the
puerperium.
O14.24.................... HELLP syndrome, complicating childbirth.
O14.25.................... HELLP syndrome, complicating the puerperium.
O14.94.................... Unspecified pre-eclampsia, complicating
childbirth.
O14.95.................... Unspecified pre-eclampsia, complicating the
puerperium.
O15.00.................... Eclampsia complicating pregnancy,
unspecified trimester.
O15.02.................... Eclampsia complicating pregnancy, second
trimester.
O15.03.................... Eclampsia complicating pregnancy, third
trimester.
O15.1..................... Eclampsia complicating labor.
O15.2..................... Eclampsia complicating puerperium, second
trimester.
O16.4..................... Unspecified maternal hypertension,
complicating childbirth.
O16.5..................... Unspecified maternal hypertension,
complicating the puerperium.
------------------------------------------------------------------------
Response: As discussed in the FY 2019 IPPS/LTCH PPS proposed rule
(83 FR 20236 through 20239), we proposed to remove the special logic in
the GROUPER for processing claims containing a diagnosis code from the
Principal Diagnosis Is Its Own CC or MCC Lists. For the reasons stated
in section II.F.15.c. of the preamble of this final rule, we are
finalizing that proposal, and therefore this logic will no longer apply
for FY 2019. We refer readers to section II.F.15.c. of the preamble of
this final rule for further discussion of the specific proposal,
including summaries of the public comments we received and our
responses and our statement of final policy.
With regard to the commenter's concern that the diagnosis codes
listed above appear to be missing from the GROUPER logic, we note that,
currently, all of the diagnoses codes are included in the MDC 14
Assignment of Diagnosis Codes List. The diagnosis codes that include
the terminology ``complicating the puerperium'' are listed under the
``Second Condition--Principal or Secondary Diagnosis'' code list in the
diagnosis code logic for MS-DRG 774, and the diagnosis codes that
include the terminology ``complicating childbirth'' are listed under
the ``Principal Diagnosis'' code list for the diagnosis code logic for
MS-DRG 781 (Other Antepartum Diagnoses with Medical Complications). We
acknowledge that the diagnosis codes that include the
[[Page 41215]]
terminology ``complicating childbirth'' that the commenter referenced
were inadvertently omitted, and are not listed in the ICD-10 MS-DRG
Definitions Manual Version 35 under the diagnosis code logic list for
MS-DRG 774 (or for MS-DRGs 767 (Vaginal Delivery with Sterilization
and/or D&C) and 768 (Vaginal Delivery with O.R. Procedure Except
Sterilization and/or D&C)). However, if one of those diagnosis codes is
reported with a procedure code from the vaginal delivery code list, the
ICD-10 MS-DRG GROUPER Version 35 accurately groups the case to a
vaginal delivery MS-DRG.
As stated in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20220),
in our proposal for restructuring the MDC 14 MS-DRGs under the ICD-10
MS-DRGs Version 36, diagnoses described as occurring during pregnancy
and diagnoses specifying a trimester or maternal care in the absence of
a delivery procedure reported are considered antepartum conditions.
Also, as shown in Table 6P.1j. associated with the proposed rule
(available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2019-IPPS-Proposed-Rule-Home-Page-Items/FY2019-IPPS-Proposed-Rule-Tables.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending), we did
not propose to include any diagnosis codes describing a condition as
``complicating childbirth'' in the list of diagnosis codes describing
antepartum conditions. Therefore, the diagnosis codes described as
``complicating childbirth'' would be applicable when a patient is
admitted for a delivery episode and are subject to MS-DRG assignment to
proposed MS-DRGs describing a cesarean or vaginal delivery.
Comment: Another commenter agreed with CMS' initiative to
restructure the MS-DRGs and GROUPER logic under MDC 14. However, the
commenter expressed concerns with the proposed GROUPER logic, and
requested CMS consider all of the issues prior to implementing the
proposed new MS-DRGs and GROUPER logic. The commenter believed that
grouping a vaginal delivery by procedure codes describing a delivery
and a diagnosis code describing the outcome of delivery did not seem
appropriate. The commenter stated that it is necessary to determine if
a case should be assigned to a vaginal delivery MS-DRG based on the
combination of principal diagnoses and procedure codes versus the
combination of a procedure code with an outcome of delivery code. The
commenter recommended that the first consideration should consist of
identification of a principal diagnosis code within the O00-O08 code
range (Pregnancy with Abortive Outcome) and then proceeding with
grouping those cases to the Abortion MS-DRGs 770 (Abortion with D&C,
Aspiration Curettage or Hysterotomy) and 779 (Abortion without D&C),
prior to possibly grouping the cases to the cesarean or vaginal
delivery MS-DRGs. The commenter provided the example of a blighted ovum
that may be treated with ICD-10-PCS procedure codes 10D07Z6 (Extraction
of products of conception, vacuum, via natural or artificial opening)
or 10D07Z8 (Extraction of products of conception, other, via natural or
artificial opening), which are reported for vaginal deliveries.
Response: We appreciate the commenter's support for the effort to
restructure the MS-DRGs and GROUPER logic under MDC 14. However, with
respect to the commenter's concerns regarding the proposed new GROUPER
logic for a vaginal delivery, we disagree with the commenter that it is
necessary to determine if cases should be assigned to a vaginal
delivery MS-DRG based on the combination of principal diagnoses and
procedure codes versus the combination of a procedure code with an
outcome of delivery code. One of the underlying purposes of the effort
to restructure the vaginal delivery MS-DRGs was to simplify the complex
logic currently associated with the vaginal delivery MS-DRGs, which
includes multiple code lists for principal and secondary diagnoses.
Based on the proposed new structure and GROUPER logic of the MS-DRGs
under MDC 14, to identify that a vaginal delivery occurred, the logic
does not have to consider or depend on the reason the patient was
admitted. Rather, the GROUPER logic is structured to account for the
fact that a delivery took place during that hospitalization. The
delivery MS-DRGs (whether cesarean or vaginal) are specifically
intended for that reason. With regard to the example provided by the
commenter, we note that ICD-10-PCS procedure codes 10D07Z6 and 10D07Z8
are designated as non-O.R. procedures that affect the MS-DRG assignment
of specific MS-DRGs. ICD-10-PCS procedure codes 10D07Z6 and 10D07Z8
impact the MS-DRG assignment of the vaginal delivery MS-DRGs. However,
ICD-10-CM diagnosis code O02.0 (Blighted ovum and nonhydatidiform mole)
is identified as a proposed antepartum condition, as shown in Table
6P.1j. associated with the proposed rule (available via the internet on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2019-IPPS-Proposed-Rule-Home-Page-Items/FY2019-IPPS-Proposed-Rule-Tables.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending) and,
therefore, as depicted in the commenter's example, if a patient has a
principal diagnosis of a blighted ovum and either ICD-10-PCS procedure
code 10D07Z6 or 10D07Z8 is reported, the proposed new GROUPER logic
would result in an MS-DRG case assignment to one of the proposed new
MS-DRGs 831, 832, or 833 (Other Antepartum Diagnoses without O.R.
Procedure with MCC, with CC or without CC/MCC, respectively) and not a
vaginal delivery MS-DRG. The diagnosis of a blighted ovum does not
result in a viable pregnancy and, therefore, an outcome of delivery
diagnosis code would not be reported. An illustration of how this
proposed new GROUPER logic would apply for antepartum conditions was
represented in Diagram 2 of the FY 2019 IPPS/LTCH PPS proposed rule (83
FR 20225).
Comment: One commenter expressed concern about the proposed
relative weights for several of the proposed new MS-DRGs under MDC 14.
The commenter stated that the low volume of the procedures assigned to
these MS-DRGs accounted for volatility in the relative weights. With
regard to proposed new MS-DRGs 817, 818, and 819 (Other Antepartum
Diagnoses with O.R. Procedure with MCC, CC, and without CC/MCC,
respectively), the commenter stated that the proposed relative weights
for these MS-DRGs are significantly lower than the proposed relative
weights of the surgical MS-DRGs to which the procedure codes proposed
to be assigned to these proposed new MS-DRGs would map for non-
obstetrical patients. This commenter also stated that the relative
weights for proposed new MS-DRGs 806 and 807 (Vaginal Delivery without
Sterilization/D&C with CC and without CC/MCC, respectively) are lower
than the current relative weights for MS-DRGs 774 and 775 (Vaginal
Delivery with and without Complicating Diagnosis, respectively), and
believed the relative weight for proposed new MS-DRG 805 (Vaginal
Delivery without Sterilization/D&C with MCC) is likely inadequate for
the resources required to care for patients with MCC severity level
designations. The commenter suggested that CMS maintain the relative
weights for proposed new MS-DRGs 806 and 807 at the same value of
[[Page 41216]]
the current MS-DRGs, and establish a relative weight for proposed new
MS-DRG 805 that is more comparable with those values of medical MS-DRGs
with MCC severity level designations. The commenter further noted that
the relative weights for proposed new MS-DRGs 797 and 798 (Vaginal
Delivery with Sterilization/D&C with CC and without CC/MCC,
respectively) are the same value, but believed the relative weight
should be greater for proposed new MS-DRG 797. The commenter also
believed that the relative weight for proposed new MS-DRG 786 (Cesarean
Section without Sterilization with MCC) is insufficient for the
required resources necessary to perform these procedures and provide
the appropriate care to patients, and requested CMS establish a
relative weight with a value more consistent with values of surgical
MS-DRGs with MCC severity level designations. The commenter also
requested that CMS maintain the relative weights for MS-DRG 787
(Cesarean Section without Sterilization with CC) at the same value of
current MS-DRG 765 (Cesarean Section with CC/MCC), and the relative
weight for proposed new MS-DRG 833 (Other Antepartum Diagnoses without
O.R. Procedure without CC/MCC) at the same value of current MS-DRG 782
(Other Antepartum Diagnoses without Medical Complications).
Response: It is to be expected that when MS-DRGs are restructured,
resulting in a different case-mix within the new MS-DRGs, the relative
weights of the MS-DRGs will change as a result. With respect to the
comment about the low volume of cases, as we have noted in the proposed
rule, we were unable to use our usual criterion of ensuring that there
are at least 500 cases in the MCC or CC group to refine the maternity
MS-DRGs because of the extremely low volume of Medicare patients cases
reflected in claims data for these DRGs. While there is not a high
volume of these cases represented in the Medicare data, and while we
generally advise that other payers should develop MS-DRGs to address
the needs of their patients, we continue to believe that the
restructured MS-DRGs within MDC 14 serve important purposes to account
for the new and different clinical concepts that exist under ICD-10 for
this subset of patients while also maintaining the existing MS-DRG
structure for identifying severity of illness, utilization of
resources, and complexity of service. We believe that even though some
of the resulting MS-DRGs have relatively low volumes in the Medicare
population, using our established methodology for developing DRG
relative weights is the most appropriate approach for the new MS-DRGs
within MDC 14. With regard to the comment about MS-DRGs 797 and 798, we
note that the average cost per case for MS-DRG 797 was lower than the
average cost per case for MS-DRG 798. Therefore, we blended the data
for these two MS-DRGs to avoid nonmonotonocity, in which the lower
severity MS-DRG has a higher relative weight than the higher severity
MS-DRG. For these reasons, we are not finalizing a change to the
calculation of the relative weights for the MS-DRGs under MDC 14.
After consideration of the public comments we received, we are
finalizing our proposals, without modification, including the list of
diagnosis codes assigned to the MS-DRGs under the restructuring of the
vaginal delivery MS-DRGs under MDC 14, which we note also addresses the
list of diagnosis codes that a commenter identified and were noted in
the proposed rule as appearing to be missing from the GROUPER logic.
We also invited public comments on our proposal to reassign ICD-10-
PCS procedure codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ that
describe dilation and curettage procedures from MS-DRG 767 under MDC 14
to MS-DRGs 744 and 745 under MDC 13.
Comment: Commenters supported CMS' proposal to reassign ICD-10-PCS
procedure codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ from MS-DRG 767
to MS-DRGs 744 and 745.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to reassign ICD-10-PCS procedure codes 0UDB7ZX,
0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ that describe dilation and curettage
procedures from MS-DRG 767 under MDC 14 to MS-DRGs 744 and 745 under
MDC 13 in the ICD-10 MS-DRGs Version 36, effective October 1, 2018.
After consideration of the public comments we received, we are
finalizing our proposed list of diagnosis and procedure codes for
assignment to the revised MDC 14 MS-DRGs including the deletion of 10
MS-DRGs and the creation of 18 new MS-DRGs in the ICD-10 MS-DRGs
Version 36, effective October 1, 2018.
11. MDC 18 (Infectious and Parasitic Diseases (Systematic or
Unspecified Sites): Systemic Inflammatory Response Syndrome (SIRS) of
Non-Infectious Origin
ICD-10-CM diagnosis codes R65.10 (Systemic Inflammatory Response
Syndrome (SIRS) of non-infectious origin without acute organ
dysfunction) and R65.11 (Systemic Inflammatory Response Syndrome (SIRS)
of non-infectious origin with acute organ dysfunction) are currently
assigned to MS-DRGs 870 (Septicemia or Severe Sepsis with Mechanical
Ventilation >96 Hours), 871 (Septicemia or Severe Sepsis with
Mechanical Ventilation >96 Hours with MCC), and 872 (Septicemia or
Severe Sepsis with Mechanical Ventilation >96 Hours without MCC) under
MDC 18 (Infectious and Parasitic Diseases, Systemic or Unspecified
Sites). As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20226), our clinical advisors noted that these diagnosis codes are
specifically describing conditions of a non-infectious origin, and
recommended that they be reassigned to a more clinically appropriate
MS-DRG.
We examined claims data from the September 2017 update of the FY
2017 MedPAR file for cases in MS-DRGs 870, 871, and 872. Our findings
are shown in the following table.
Septicemia or Severe Sepsis With and Without Mechanical Ventilation >96 Hours With and Without MCC
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 870--All cases........................................... 31,658 14.3 $42,981
MS-DRG 871--All cases........................................... 566,531 6.3 13,002
MS-DRG 872--All cases........................................... 150,437 4.3 7,532
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 31,658 cases in MS-DRG
870, with an average length of stay of 14.3 days and average costs of
$42,981. We found a total of 566,531 cases in MS-DRG 871, with an
average length of stay
[[Page 41217]]
of 6.3 days and average costs of $13,002. Lastly, we found a total of
150,437 cases in MS-DRG 872, with an average length of stay of 4.3 days
and average costs of $7,532.
We then examined claims data in MS-DRGs 870, 871, or 872 for cases
reporting an ICD-10-CM diagnosis code of R65.10 or R65.11. Our findings
are shown in the following table.
SIRS of Non-Infectious Origin With and Without Acute Organ Dysfunction
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRGs 870, 871 and 872 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 870, 871, and 872--Cases reporting a principal diagnosis 1,254 3.8 $6,615
code of R65.10.................................................
MS-DRGs 870, 871, and 872--Cases reporting a principal diagnosis 138 4.8 9,655
code of R65.11.................................................
MS-DRGs 870, 871, and 872--Cases reporting a secondary diagnosis 1,232 5.5 10,670
code of R65.10.................................................
MS-DRGs 870, 871, and 872--Cases reporting a secondary diagnosis 117 6.2 12,525
code of R65.11.................................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 1,254 cases reporting a
principal diagnosis code of R65.10 in MS-DRGs 870, 871, and 872, with
an average length of stay of 3.8 days and average costs of $6,615. We
found a total of 138 cases reporting a principal diagnosis code of
R65.11 in MS-DRGs 870, 871, and 872, with an average length of stay of
4.8 days and average costs of $9,655. We found a total of 1,232 cases
reporting a secondary diagnosis code of R65.10 in MS-DRGs 870, 871, and
872, with an average length of stay of 5.5 days and average costs of
$10,670. Lastly, we found a total of 117 cases reporting a secondary
diagnosis code of R65.11 in MS-DRGs 870, 871, and 872, with an average
length of stay of 6.2 days and average costs of $12,525.
The claims data included a total of 1,392 cases in MS-DRGs 870,
871, and 872 that reported a principal diagnosis code of R65.10 or
R65.11. We noted in the FY 2019 IPPS/LTCH PPS proposed rule that these
1,392 cases appear to have been coded inaccurately according to the
ICD-10-CM Official Guidelines for Coding and Reporting at Section
I.C.18.g., which specifically state: ``The systemic inflammatory
response syndrome (SIRS) can develop as a result of certain non-
infectious disease processes, such as trauma, malignant neoplasm, or
pancreatitis. When SIRS is documented with a non-infectious condition,
and no subsequent infection is documented, the code for the underlying
condition, such as an injury, should be assigned, followed by code
R65.10, Systemic inflammatory response syndrome (SIRS) of non-
infectious origin without acute organ dysfunction or code R65.11,
Systemic inflammatory response syndrome (SIRS) of non-infectious origin
with acute organ dysfunction.'' Therefore, according to the Coding
Guidelines, ICD-10-CM diagnosis codes R65.10 and R65.11 should not be
reported as the principal diagnosis on an inpatient claim.
We have acknowledged in past rulemaking the challenges with coding
for SIRS (and sepsis) (71 FR 24037). In addition, we note that there
has been confusion with regard to how these codes are displayed in the
ICD-10 MS-DRG Definitions Manual under MS-DRGs 870, 871, and 872, which
may also impact the reporting of these conditions. For example, in
Version 35 of the ICD-10 MS-DRG Definitions Manual (which is available
via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending, the
logic for case assignment to MS-DRGs 870, 871, and 872 is comprised of
a list of several diagnosis codes, of which ICD-10-CM diagnosis codes
R65.10 and R65.11 are included. Because these codes are listed under
the heading of ``Principal Diagnosis'', it may appear that these codes
are to be reported as a principal diagnosis for assignment to MS-DRGs
870, 871, or 872. However, the Definitions Manual display of the
GROUPER logic assignment for each diagnosis code is for grouping
purposes only. The GROUPER (and, therefore, documentation in the MS-DRG
Definitions Manual) was not designed to account for coding guidelines
or coverage policies. Since the inception of the IPPS, the data editing
function has been a separate and independent step in the process of
determining a DRG assignment. Except for extreme data integrity issues
that prevent a DRG from being assigned, such as an invalid principal
diagnosis, the DRG assignment GROUPER does not edit for data integrity.
Prior to assigning the MS-DRG to a claim, the MACs apply a series of
data integrity edits using programs such as the Medicare Code Editor
(MCE). The MCE is designed to identify cases that require further
review before classification into an MS-DRG. These data integrity edits
address issues such as data validity, coding rules, and coverage
policies. The separation of the MS-DRG grouping and data editing
functions allows the MS-DRG GROUPER to remain stable during a fiscal
year even though coding rules and coverage policies may change during
the fiscal year. As such, in the FY 2018 IPPS/LTCH PPS final rule (82
FR 38050 through 38051), we finalized our proposal to add ICD-10-CM
diagnosis codes R65.10 and R65.11 to the Unacceptable Principal
Diagnosis edit in the MCE as a result of the Official Guidelines for
Coding and Reporting related to SIRS, in efforts to improve coding
accuracy for these types of cases.
To address the issue of determining a more appropriate MS-DRG
assignment for ICD-10-CM diagnosis codes R65.10 and R65.11, we reviewed
alternative options under MDC 18. Our clinical advisors determined the
most appropriate option is MS-DRG 864 (Fever) because the conditions
that are assigned here describe conditions of a non-infectious origin.
Therefore, in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20227), we proposed to reassign ICD-10-CM diagnosis codes R65.10 and
R65.11 to MS-DRG 864 and to revise the title of MS-DRG 864 to ``Fever
and Inflammatory Conditions'' to better reflect the diagnoses assigned
there.
[[Page 41218]]
Proposed Revised MS-DRG 864 (Fever and Inflammatory Conditions)
----------------------------------------------------------------------------------------------------------------
Average length
MS-DRG Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 864--All cases........................................ 12,144 3.4 $6,232
----------------------------------------------------------------------------------------------------------------
Comment: Commenters supported the proposal to reassign ICD-10-CM
diagnosis codes R65.10 and R65.11 to MS-DRG 864 and to revise the title
of MS-DRG 864 to ``Fever and Inflammatory Conditions''.
Response: We thank the commenters for their support.
Comment: One commenter questioned the proposed logic for ICD-10-CM
diagnosis codes R65.10 and R65.11 within MS-DRG 864. The commenter
noted that the diagnosis codes are included on the unacceptable
principal diagnoses code edit list in the MCE and specifically inquired
if cases reporting diagnosis code R65.10 or R65.11 as a secondary
diagnosis would result in assignment to MS-DRG 864.
Response: The GROUPER logic assignment for each diagnosis code as a
principal diagnosis is for grouping purposes only. The GROUPER was not
designed to account for coding guidelines or coverage policies. The MCE
is designed to identify cases that require further review before
classification into an MS-DRG. Therefore, the MS-DRG logic must
specifically require a condition to group based on whether it is
reported as a principal diagnosis or a secondary diagnosis, and
consider any procedures that are reported, in addition to consideration
of the patient's age, sex and discharge status in order to affect the
MS-DRG assignment.
As noted in the ICD-10 MS-DRG Definitions Manual Version 35,
Appendix B--Diagnosis Code/MDC/MS-DRG Index, each diagnosis code is
listed with the MDC and the MS-DRGs to which the diagnosis is used to
define the logic of the DRG either as a principal diagnosis or a
secondary diagnosis. For diagnosis codes R65.10 and R65.11, the ICD-10
MS DRG Definitions Manual displays MDC 18 and MS-DRGs 870-872, as
described previously. As discussed in the proposed rule, because the
diagnosis are codes listed under the heading of ``Principal Diagnosis''
in the ICD-10 MS DRG Definitions Manual, it may appear to indicate that
these codes are to be reported as a principal diagnosis for assignment
to these MS-DRGs. However, the Definitions Manual display of the
GROUPER logic assignment for each diagnosis code is for grouping
purposes only and does not correspond to coding guidelines for
reporting the principal diagnosis. In other words, cases will group
according to the GROUPER logic, regardless of any coding guidelines or
coverage policies. It is the MCE and other payer specific edits that
identify inconsistencies in the coding guidelines or coverage policies.
Under our proposed change to the ICD-10 MS-DRGs Version 36, cases
reporting diagnosis code R65.10 or R65.11 as a secondary diagnosis
would result in assignment to MS-DRG 864 when one of the other listed
diagnosis codes in the MS-DRG 864 logic is reported as the principal
diagnosis.
After consideration of the public comments we received, we are
finalizing our proposal to reassign ICD-10-CM diagnosis codes R65.10
and R65.11 to MS-DRG 864 and to revise the title of MS-DRG 864 to
``Fever and Inflammatory Conditions''.
12. MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs): Corrosive
Burns
ICD-10-CM Coding Guidelines include ``Code first'' sequencing
instructions for cases reporting a principal diagnosis of toxic effect
(ICD-10-CM codes T51 through T65) and a secondary diagnosis of
corrosive burn (ICD-10-CM codes T21.40 through T21.79). As discussed in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20227), we received a
request to reassign these cases from MS-DRGs 901 (Wound Debridements
for Injuries with MCC), 902 (Wound Debridements for Injuries with CC),
903 (Wound Debridements for Injuries without CC/MCC), 904 (Skin Grafts
for Injuries with CC/MCC), 905 (Skin Grafts for Injuries without CC/
MCC), 917 (Poisoning and Toxic Effects of Drugs with MCC), and 918
(Poisoning and Toxic Effects of Drugs without MCC) to MS-DRGs 927
(Extensive Burns or Full Thickness Burns with Mechanical Ventilation
>96 Hours with Skin Graft), 928 (Full Thickness Burn with Skin Graft or
Inhalation Injury with CC/MCC), 929 (Full Thickness Burn with Skin
Graft or Inhalation Injury without CC/MCC), 933 (Extensive Burns or
Full Thickness Burns with Mechanical Ventilation >96 Hours without Skin
Graft), 934 (Full Thickness Burn without Skin Graft or Inhalation
Injury), and 935 (Nonextensive Burns).
The requestor noted that, for corrosion burns codes T21.40 through
T21.79, ICD-10-CM Coding Guidelines instruct to ``Code first (T51
through T65) to identify chemical and intent.'' Because code first
notes provide sequencing directive, when patients are admitted with
corrosive burns (which can be full thickness and extensive), toxic
effect codes T51 through T65 must be sequenced first followed by codes
for the corrosive burns. This causes full-thickness and extensive burns
to group to MS-DRGs 901 through 905 when excisional debridement and
split thickness skin grafts are performed, and to MS-DRGs 917 and 918
when procedures are not performed. This is in contrast to cases
reporting a principal diagnosis of corrosive burn, which group to MS-
DRGs 927 through 935.
The requestor stated that MS-DRGs 456 (Spinal Fusion except
Cervical with Spinal Curvature or Malignancy or Infection or Extensive
Fusions with MCC), 457 (Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or Extensive Fusions with CC), and
458 (Spinal Fusion Except Cervical with Spinal Curvature or Malignancy
or Infection or Extensive Fusions without CC/MCC) are grouped based on
the procedure performed in combination with the principal diagnosis or
secondary diagnosis (secondary scoliosis). The requestor stated that
when codes for corrosive burns are reported as secondary diagnoses in
conjunction with principal diagnoses codes T5l through T65,
particularly when skin grafts are performed, they would be more
appropriately assigned to MS-DRGs 927 through 935.
We analyzed claims data from the September 2017 update of the FY
2017 MedPAR file for all cases assigned to MS-DRGs 901, 902, 903, 904,
905, 917, and 918, and subsets of these cases with principal diagnosis
of toxic effect with secondary diagnosis of corrosive burn. We noted in
the proposed rule that we found no cases from this subset in MS-DRGs
903, 907, 908, and 909 and, therefore, did not include the results for
these MS-DRGs in the table below. We also analyzed all cases assigned
to MS-DRGs 927, 928, 929, 933, 934, and 935 and those cases that
reported a principal diagnosis of corrosive burn. Our findings are
shown in the following two tables.
[[Page 41219]]
MDC 21 Injuries, Poisonings and Toxic Effects of Drugs
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRGs cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All Cases with principal diagnosis of toxic effect and secondary 55 5.5 $18,077
diagnosis of corrosive burn--Across all MS-DRGs................
MS-DRG 901--All cases........................................... 968 13 31,479
MS-DRG 901--Cases with principal diagnosis of toxic effect and 1 8 12,388
secondary diagnosis of corrosive burn..........................
MS-DRG 902--All cases........................................... 1,775 6.6 14,206
MS-DRG 902--Cases with principal diagnosis of toxic effect and 8 10.3 20,940
secondary diagnosis of corrosive burn..........................
MS-DRG 904--All cases........................................... 905 9.8 23,565
MS-DRG 904--Cases with principal diagnosis of toxic effect and 8 6.4 22,624
secondary diagnosis of corrosive burn..........................
MS-DRG 905--All cases........................................... 263 4.9 13,291
MS-DRG 905--Cases with principal diagnosis of toxic effect and 2 2.5 7,682
secondary diagnosis of corrosive burn..........................
MS-DRG 906--All cases........................................... 458 4.8 13,555
MS-DRG 906--Cases with principal diagnosis of toxic effect and 1 5 7,409
secondary diagnosis of corrosive burn..........................
MS-DRG 917--All cases........................................... 31,730 4.8 10,280
MS-DRG 917--Cases with principal diagnosis of toxic effect and 6 4.8 7,336
secondary diagnosis of corrosive burn..........................
MS-DRG 918--All cases........................................... 19,819 3 5,529
MS-DRG 918--Cases with principal diagnosis of toxic effect and 28 3.5 5,643
secondary diagnosis of corrosive burn..........................
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 55 cases with a
principal diagnosis of toxic effect and a secondary diagnosis of
corrosive burn across MS-DRGs 901, 902, 903, 904, 905, 917, and 918.
When comparing this subset of codes relative to those of each MS-DRG as
a whole, we noted that, in most of these MS-DRGs, the average costs and
average length of stay for this subset of cases were roughly equivalent
to or lower than the average costs and average length of stay for cases
in the MS-DRG as a whole, while in one case, they were higher. As we
have noted in prior rulemaking (77 FR 53309) and elsewhere in the
proposed rule and this final rule, it is a fundamental principle of an
averaged payment system that half of the procedures in a group will
have above average costs. It is expected that there will be higher cost
and lower cost subsets, especially when a subset has low numbers. We
stated in the proposed rule that the results of this analysis indicate
that these cases are appropriately placed within their current MDC.
Our clinical advisors reviewed this request and indicated that
patients with a principal diagnosis of toxic effect and a secondary
diagnosis of corrosive burn have been exposed to an irritant or
corrosive substance and, therefore, are clinically similar to those
patients in MDC 21. Furthermore, our clinical advisors did not believe
that the size of this subset of cases justifies the significant changes
to the GROUPER logic that would be required to address the commenter's
request, which would involve rerouting cases when the primary and
secondary diagnoses are in different MDCs.
MDC 22 Burns
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with principal diagnosis of corrosive burn--Across all 60 8.5 $19,456
MS-DRGs........................................................
MS-DRG 927--All cases........................................... 159 28.1 128,960
MS-DRG 927--Cases with principal diagnosis of corrosive burn.... 1 41 75,985
MS-DRG 928--All cases........................................... 1,021 15.1 42,868
MS-DRG 928--Cases with principal diagnosis of corrosive burn.... 13 13.2 31,118
MS-DRG 929--All cases........................................... 295 7.9 21,600
MS-DRG 929--Cases with principal diagnosis of corrosive burn.... 4 12.5 18,527
MS-DRG 933--All cases........................................... 121 4.6 21,291
MS-DRG 933--Cases with principal diagnosis of corrosive burn.... 1 7 91,779
MS-DRG 934--All cases........................................... 503 6.1 13,286
MS-DRG 934--Cases with principal diagnosis of corrosive burn.... 11 5.8 13,280
MS-DRG 935--All cases........................................... 1,705 5.2 13,065
MS-DRG 935--Cases with principal diagnosis of corrosive burn.... 29 5 9,822
----------------------------------------------------------------------------------------------------------------
To address the request of reassigning cases with a principal
diagnosis of toxic effect and secondary diagnosis of corrosive burn, we
reviewed the data for all cases in MS-DRGs 927, 928, 929, 933, 934, and
935 and those cases reporting a principal diagnosis of corrosive burn.
We found a total of 60 cases reporting a principal diagnosis of
corrosive burn, with an average length of stay of 8.5 days and average
costs of $19,456. We stated in the proposed rule that our clinical
advisors believe that these cases reporting a principal diagnosis of
corrosive burn are appropriately placed in MDC 22 as they are
clinically aligned with other patients in this MDC. We further stated
that, in
[[Page 41220]]
summary, the results of our claims data analysis and the advice from
our clinical advisors do not support reassigning cases in MS-DRGs 901,
902, 903, 904, 905, 917, and 918 reporting a principal diagnosis of
toxic effect and a secondary diagnosis of corrosive burn to MS-DRGs
927, 928, 929, 933, 934 and 935. Therefore, we did not propose to
reassign these cases.
Comment: One commenter supported the proposal to maintain the
current MS-DRG structure for cases reporting a principal diagnosis of
toxic effect (ICD-10-CM codes T51 through T65) and a secondary
diagnosis of corrosive burn (ICD-10-CM codes T21.40 through T21.79).
Another commenter suggested that the 60 identified cases that CMS used
in its analysis were incorrectly coded. The commenter noted that ICD-
10-CM coding guidelines under each code for corrosion burn state ``Code
first (T51-T65) to identify chemical and intent.'' The commenter stated
that corrosive burns cannot be sequenced as the principal diagnosis
because the coding guidelines must be followed. The commenter stated
that the toxic effect codes T51-T65 must be sequenced first, which
causes these cases to group to MS-DRGs 901 through 905 and 917 and 918
instead of the more appropriate burn MS-DRGs. The commenter stated that
it appears that when codes T51-T65 are the principal diagnosis, the
cases group to MDC 21 (Injuries, Poisoning. and Toxic Effects of
Drugs), and then to MS-DRGs 901 through 905 and 917 and 918.
Response: We appreciate the commenter's support. With regard to the
commenter who raised concerns about the coding guidelines and display
of codes in the ICD-10 MS-DRG Definitions Manual, we note that the
GROUPER logic was not designed to account for coding guidelines. With
regard to the display of code lists in the ICD-10 MS-DRG Definitions
Manual, the MS-DRG logic must specifically require a condition to group
based on whether it is reported as a principal diagnosis or a secondary
diagnosis and consider any procedures that are reported in order to
affect the MS-DRG assignment. However, as stated previously, the
GROUPER logic is not dependent on coding guidelines. The purpose of the
GROUPER is to group cases into particular MS-DRGs. We recognize that,
over time, the desire to create or modify existing GROUPER logic in
response to coding guidelines has become more common. As we continue
our efforts to refine the ICD-10 MS-DRGs, we will consider alternate
approaches to ensure the integrity of both the GROUPER logic and coding
guidelines. Based on the data available at this time, we do not believe
that it is appropriate to change the MS-DRG assignment for the
procedures identifying corrosive burns identified earlier.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current MS-DRG structure for
cases reporting a principal diagnosis of toxic effect (ICD-10-CM codes
T51 through T65) and a secondary diagnosis of corrosive burn (ICD-10-CM
codes T21.40 through T21.79).
13. Changes to the Medicare Code Editor (MCE)
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 the FY 2018 IPPS/LTCH PPS final rule (82 FR 38045),
we made available the FY 2018 ICD-10 MCE Version 35 manual file. The
link to this MCE manual file, along with the link to the mainframe and
computer software for the MCE Version 35 (and ICD-10 MS-DRGs) are
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html through the FY 2018
IPPS Final Rule Home Page.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20229), we
addressed the MCE requests we received by the November 1, 2017
deadline. We also discussed the proposals we were making based on our
internal review and analysis. In this FY 2019 IPPS/LTCH PPS final rule,
we present a summation of the comments we received in response to the
MCE requests and proposals presented based on internal reviews and
analyses in the proposed rule, our responses to those comments, and our
finalized policies.
In addition, as a result of new and modified code updates approved
after the annual spring ICD-10 Coordination and Maintenance Committee
meeting, we routinely make changes to the MCE. In the past, in both the
IPPS proposed and final rules, we only provided the list of changes to
the MCE that were brought to our attention after the prior year's final
rule. We historically have not listed the changes we have made to the
MCE as a result of the new and modified codes approved after the annual
spring ICD-10 Coordination and Maintenance Committee meeting. These
changes are approved too late in the rulemaking schedule for inclusion
in the proposed rule. Furthermore, although our MCE policies have been
described in our proposed and final rules, we have not provided the
detail of each new or modified diagnosis and procedure code edit in the
final rule. However, we make available the finalized Definitions of
Medicare Code Edits (MCE) file. Therefore, we are making available the
FY 2019 ICD-10 MCE Version 36 Manual file, along with the link to the
mainframe and computer software for the MCE Version 36 (and ICD-10 MS
DRGs), on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html.
a. Age Conflict Edit
In the MCE, the Age Conflict edit exists to detect inconsistencies
between a patient's age and any diagnosis on the patient's record; for
example, a 5-year-old patient with benign prostatic hypertrophy or a
78-year-old patient coded with a delivery. In these cases, the
diagnosis is clinically and virtually impossible for a patient of the
stated age. Therefore, either the diagnosis or the age is presumed to
be incorrect. Currently, in the MCE, the following four age diagnosis
categories appear under the Age Conflict edit and are listed in the
manual and written in the software program:
Perinatal/Newborn--Age of 0 years only; a subset of
diagnoses which will only occur during the perinatal or newborn period
of age 0 (for example, tetanus neonatorum, health examination for
newborn under 8 days old).
Pediatric--Age is 0-17 years inclusive (for example,
Reye's syndrome, routine child health exam).
Maternity--Age range is 12-55 years inclusive (for
example, diabetes in pregnancy, antepartum pulmonary complication).
Adult--Age range is 15-124 years inclusive (for example,
senile delirium, mature cataract).
(1) Perinatal/Newborn Diagnoses Category
Under the ICD-10 MCE, the Perinatal/Newborn Diagnoses category
under the Age Conflict edit considers the age of 0 years only; a subset
of diagnoses which will only occur during the perinatal or newborn
period of age 0 to be inclusive. This includes conditions that have
their origin in the fetal or perinatal period (before birth through the
first 28 days
[[Page 41221]]
after birth) even if morbidity occurs later. For that reason, the
diagnosis codes on this Age Conflict edit list would be expected to
apply to conditions or disorders specific to that age group only.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20229), we
indicated that, in the ICD-10-CM classification, there are 14 diagnosis
codes that describe specific suspected conditions that have been
evaluated and ruled out during the newborn period and are currently not
on the Perinatal/Newborn Diagnoses Category edit code list. We
consulted with staff at the Centers for Disease Control's (CDC's)
National Center for Health Statistics (NCHS) because NCHS has the lead
responsibility for the ICD-10-CM diagnosis codes. The NCHS' staff
confirmed that the following diagnosis codes are appropriate to add to
the edit code list for the Perinatal/Newborn Diagnoses Category.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Z05.0..................... Observation and evaluation of newborn for
suspected cardiac condition ruled out.
Z05.1..................... Observation and evaluation of newborn for
suspected infectious condition ruled out.
Z05.2..................... Observation and evaluation of newborn for
suspected neurological condition ruled out.
Z05.3..................... Observation and evaluation of newborn for
suspected respiratory condition ruled out.
Z05.41.................... Observation and evaluation of newborn for
suspected genetic condition ruled out.
Z05.42.................... Observation and evaluation of newborn for
suspected metabolic condition ruled out.
Z05.43.................... Observation and evaluation of newborn for
suspected immunologic condition ruled out.
Z05.5..................... Observation and evaluation of newborn for
suspected gastrointestinal condition ruled
out.
Z05.6..................... Observation and evaluation of newborn for
suspected genitourinary condition ruled
out.
Z05.71.................... Observation and evaluation of newborn for
suspected skin and subcutaneous tissue
condition ruled out.
Z05.72.................... Observation and evaluation of newborn for
suspected musculoskeletal condition ruled
out.
Z05.73.................... Observation and evaluation of newborn for
suspected connective tissue condition ruled
out.
Z05.8..................... Observation and evaluation of newborn for
other specified suspected condition ruled
out.
Z05.9..................... Observation and evaluation of newborn for
unspecified suspected condition ruled out.
------------------------------------------------------------------------
Therefore, we proposed to add the ICD-10-CM diagnosis codes listed
in the table above to the Age Conflict edit under the Perinatal/Newborn
Diagnoses Category edit code list. We also proposed to continue to
include the existing diagnosis codes currently listed under the
Perinatal/Newborn Diagnoses Category edit code list.
Comment: Commenters agreed with CMS' proposal to add the diagnosis
codes listed in the table above to the Age Conflict edit under the
Perinatal/Newborn Diagnoses Category edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add the ICD-10-CM diagnosis codes listed in
the table above to the Age Conflict edit under the Perinatal/Newborn
Diagnoses Category edit code list. We also are finalizing our proposal
to continue to include the existing list of codes on the Perinatal/
Newborn Diagnoses Category edit code list under the ICD-10 MCE Version
36, effective October 1, 2018.
(2) Pediatric Diagnoses Category
Under the ICD-10 MCE, the Pediatric Diagnoses Category for the Age
Conflict edit considers the age range of 0 to 17 years inclusive. For
that reason, the diagnosis codes on this Age Conflict edit list would
be expected to apply to conditions or disorders specific to that age
group only.
As discussed in section II.F.15. of the preamble of the proposed
rule, Table 6C.--Invalid Diagnosis Codes associated with the proposed
rule and this final (which is available via the internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) lists the diagnoses that will no
longer be effective as of October 1, 2018. Included in this table is an
ICD-10-CM diagnosis code currently listed on the Pediatric Diagnoses
Category edit code list, ICD-10-CM diagnosis code Z13.4 (Encounter for
screening for certain developmental disorders in childhood). In the FY
2019 IPPS/LTCH PPS proposed rule (83 FR 20230), we proposed to remove
this code from the Pediatric Diagnoses Category edit code list. We also
proposed to continue to include the other existing diagnosis codes
currently listed under the Pediatric Diagnoses Category edit code list.
Comment: Commenters agreed with the proposal to remove ICD-10-CM
diagnosis code Z13.4 from the Pediatric Diagnoses Category edit code
list because this code will no longer be effective as of October 1,
2018.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to remove ICD-10-CM diagnosis code Z13.4 from
the Pediatric Diagnoses Category edit code list. We also are finalizing
our proposal to maintain the other existing codes on the Pediatric
Diagnoses Category edit code list under the ICD-10 MCE Version 36,
effective October 1, 2018.
(3) Maternity Diagnoses
Under the ICD-10 MCE, the Maternity Diagnoses Category for the Age
Conflict edit considers the age range of 12 to 55 years inclusive. For
that reason, the diagnosis codes on this Age Conflict edit list would
be expected to apply to conditions or disorders specific to that age
group only.
As discussed in section II.F.15. of the preamble of the proposed
rule, Table 6A.--New Diagnosis Codes associated with the proposed rule
(which is available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the new diagnoses codes that had
been approved to date, which will be effective with discharges
occurring on and after October 1, 2018. The following table lists the
new ICD-10-CM diagnosis codes included in Table 6A associated with
pregnancy and maternal care that we stated we believe are appropriate
to add to the Maternity Diagnoses Category edit code list under the Age
Conflict edit. Therefore, in the proposed rule, we proposed to add
these codes to the Maternity Diagnoses Category edit code list under
the Age Conflict edit.
[[Page 41222]]
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
F53.0..................... Postpartum depression.
F53.1..................... Puerperal psychosis.
O30.131................... Triplet pregnancy, trichorionic/triamniotic,
first trimester.
O30.132................... Triplet pregnancy, trichorionic/triamniotic,
second trimester.
O30.133................... Triplet pregnancy, trichorionic/triamniotic,
third trimester.
O30.139................... Triplet pregnancy, trichorionic/triamniotic,
unspecified trimester.
O30.231................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, first trimester.
O30.232................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, second trimester.
O30.233................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, third trimester.
O30.239................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, unspecified trimester.
O30.831................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, first trimester.
O30.832................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, second trimester.
O30.833................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, third trimester.
O30.839................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, unspecified
trimester.
O86.00.................... Infection of obstetric surgical wound,
unspecified.
O86.01.................... Infection of obstetric surgical wound,
superficial incisional site.
O86.02.................... Infection of obstetric surgical wound, deep
incisional site.
O86.03.................... Infection of obstetric surgical wound, organ
and space site.
O86.04.................... Sepsis following an obstetrical procedure.
O86.09.................... Infection of obstetric surgical wound, other
surgical site.
------------------------------------------------------------------------
In addition, as discussed in section II.F.15. of the preamble of
the proposed rule, Table 6C.--Invalid Diagnosis Codes associated with
the proposed rule (which is available via the internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the diagnosis codes that
will no longer be effective as of October 1, 2018. Included in this
table are two ICD-10-CM diagnosis codes currently listed on the
Maternity Diagnoses Category edit code list: ICD-10-CM diagnosis codes
F53 (Puerperal psychosis) and O86.0 (Infection of obstetric surgical
wound). In the proposed rule, we proposed to remove these codes from
the Maternity Diagnoses Category Edit code list. We also proposed to
continue to include the other existing diagnosis codes currently listed
under the Maternity Diagnoses Category edit code list.
Comment: Commenters agreed with the proposal to add the diagnosis
codes listed in the table above to the Maternity Diagnoses Category
edit code list. Commenters also agreed with the proposal to remove ICD-
10-CM diagnosis codes F53 and O86.0 from the Maternity Diagnoses
Category edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add the diagnosis codes listed in the table
above to the Maternity Diagnoses Category edit code list and our
proposal to remove ICD-10-CM diagnosis codes F53 and O86.0 from the
Maternity Diagnoses Category edit code list. We also are finalizing our
proposal to maintain the other existing codes on the Maternity
Diagnoses Category edit code list under the ICD-10 MCE Version 36,
effective October 1, 2018.
b. Sex Conflict Edit
In the MCE, the Sex Conflict edit detects inconsistencies between a
patient's sex and any diagnosis or procedure on the patient's record;
for example, a male patient with cervical cancer (diagnosis) or a
female patient with a prostatectomy (procedure). In both instances, the
indicated diagnosis or the procedure conflicts with the stated sex of
the patient. Therefore, the patient's diagnosis, procedure, or sex is
presumed to be incorrect.
(1) Diagnoses for Females Only Edit
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20231), we
indicated that we received a request to consider the addition of the
following ICD-10-CM diagnosis codes to the list for the Diagnoses for
Females Only edit.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Z30.015................... Encounter for initial prescription of
vaginal ring hormonal contraceptive.
Z31.7..................... Encounter for procreative management and
counseling for gestational carrier.
Z98.891................... History of uterine scar from previous
surgery.
------------------------------------------------------------------------
The requestor noted that, currently, ICD-10-CM diagnosis code
Z30.44 (Encounter for surveillance of vaginal ring hormonal
contraceptive device) is on the Diagnoses for Females Only edit code
list and suggested that ICD-10-CM diagnosis code Z30.015, which also
describes an encounter involving a vaginal ring hormonal contraceptive,
be added to the Diagnoses for Females Only edit code list as well. In
addition, the requestor suggested that ICD-10-CM diagnosis codes Z31.7
and Z98.891 be added to the Diagnoses for Females Only edit code list.
We reviewed ICD-10-CM diagnosis codes Z30.015, Z31.7, and Z98.891,
and we agreed with the requestor that it is clinically appropriate to
add these three ICD-10-CM diagnosis codes to the Diagnoses for Females
Only edit code list because the conditions described by these codes are
specific to and consistent with the female sex.
In addition, as discussed in section II.F.15. of the preamble of
the proposed rule, Table 6A.--New Diagnosis Codes associated with the
proposed rule (which is available via the internet on the CMS website
at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed
[[Page 41223]]
the new diagnosis codes that had been approved to date, which will be
effective with discharges occurring on and after October 1, 2018. The
following table lists the new diagnosis codes that are associated with
conditions consistent with the female sex. We proposed to add these
ICD-10-CM diagnosis codes to the Diagnoses for Females Only edit code
list under the Sex Conflict edit.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
F53.0..................... Postpartum depression.
F53.1..................... Puerperal psychosis.
N35.82.................... Other urethral stricture, female.
N35.92.................... Unspecified urethral stricture, female.
O30.131................... Triplet pregnancy, trichorionic/triamniotic,
first trimester.
O30.132................... Triplet pregnancy, trichorionic/triamniotic,
second trimester.
O30.133................... Triplet pregnancy, trichorionic/triamniotic,
third trimester.
O30.139................... Triplet pregnancy, trichorionic/triamniotic,
unspecified trimester.
O30.231................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, first trimester.
O30.232................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, second trimester.
O30.233................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, third trimester.
O30.239................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, unspecified trimester.
O30.831................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, first trimester.
O30.832................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, second trimester.
O30.833................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, third trimester.
O30.839................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, unspecified
trimester.
O86.00.................... Infection of obstetric surgical wound,
unspecified.
O86.01.................... Infection of obstetric surgical wound,
superficial incisional site.
O86.02.................... Infection of obstetric surgical wound, deep
incisional site.
O86.03.................... Infection of obstetric surgical wound, organ
and space site.
O86.04.................... Sepsis following an obstetrical procedure.
O86.09.................... Infection of obstetric surgical wound, other
surgical site.
Q51.20.................... Other doubling of uterus, unspecified.
Q51.21.................... Other complete doubling of uterus.
Q51.22.................... Other partial doubling of uterus.
Q51.28.................... Other doubling of uterus, other specified.
Z13.32.................... Encounter for screening for maternal
depression.
------------------------------------------------------------------------
Comment: Commenters supported the proposals to add ICD-10-CM
diagnosis codes Z30.015, Z31.7 and Z98.891 and the ICD-10-CM diagnosis
codes listed in the table above to the Diagnoses for Females Only edit
code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposals to add ICD-10-CM diagnosis codes Z30.015,
Z31.7 and Z98.891 and the ICD-10-CM diagnosis codes listed in the table
above to the Diagnoses for Females Only edit code list under the ICD-10
MCE Version 36, effective October 1, 2018.
In addition, as discussed in section II.F.15. of the preamble of
the proposed rule, Table 6C.--Invalid Diagnosis Codes associated with
the proposed rule (which is available via the internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the diagnosis codes that
are no longer effective as of October 1, 2018. Included in this table
were the following three ICD-10-CM diagnosis codes currently listed on
the Diagnoses for Females Only edit code list.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
F53....................... Puerperal psychosis.
O86.0..................... Infection of obstetric surgical wound.
Q51.2..................... Other doubling of uterus, unspecified.
------------------------------------------------------------------------
Because these three ICD-10-CM diagnosis codes will no longer be
effective as of October 1, 2018, we proposed to remove them from the
Diagnoses for Females Only edit code list under the Sex Conflict edit.
Comment: Commenters supported the proposal to remove ICD-10-CM
diagnosis codes F53, O86.0, and Q51.2, from the Diagnoses for Females
Only edit code list, as they are no longer valid effective October 1,
2018. One commenter also noted that there were typographical errors in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20232) for diagnosis
codes O86.0 and Q51.2, where an extra zero was inadvertently included
as a fifth digit.
Response: We appreciate the commenters' support. We agree with the
commenter that there were typographical errors in the FY 2019 IPPS/LTCH
PPS proposed rule (83 FR 20232) for diagnosis codes O86.0 and Q51.2,
where an extra zero was inadvertently included as a fifth digit, and
have corrected these errors in the table presented in this final rule
preamble.
After consideration of the public comments we received, we are
finalizing our proposal to remove ICD-10-CM diagnosis codes F53, O86.0,
and Q51.2, from the Diagnoses for Females Only edit code list under the
ICD-10 MCE Version 36, effective October 1, 2018.
[[Page 41224]]
(2) Procedures for Females Only Edit
As discussed in section II.F.15. of the preamble of the FY 2019
IPPS/LTCH PPS proposed rule, Table 6B.--New Procedure Codes associated
with the proposed rule (which is available via the internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the procedure codes that
had been approved to date, which will be effective with discharges
occurring on and after October 1, 2018. In the proposed rule, we
proposed to add the three ICD-10-PCS procedure codes in the following
table describing procedures associated with the female sex to the
Procedures for Females Only edit code list.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0UY90Z0................... Transplantation of uterus, allogeneic, open
approach.
0UY90Z1................... Transplantation of uterus, syngeneic, open
approach.
0UY90Z2................... Transplantation of uterus, zooplastic, open
approach.
------------------------------------------------------------------------
We also proposed to continue to include the existing procedure
codes currently listed under the Procedures for Females Only edit code
list.
Comment: Commenters supported the proposal to add ICD-10-PCS
procedure codes 0UY90Z0, 0UY90Z1 and 0UY90Z2 to the Procedures for
Females Only edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add ICD-10-PCS procedure codes 0UY90Z0,
0UY90Z1 and 0UY90Z2 to the Procedures for Females Only edit code list.
We also are finalizing our proposal to maintain the existing list of
codes on the Procedures for Females Only edit code list under the ICD-
10 MCE Version 36, effective October 1, 2018.
(3) Diagnoses for Males Only Edit
As discussed in section II.F.15. of the preamble of the proposed
rule, Table 6A.--New Diagnosis Codes associated with the proposed rule
(which is available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the new diagnosis codes that had
been approved to date, which will be effective with discharges
occurring on and after October 1, 2018. The following table lists the
new diagnosis codes that are associated with conditions consistent with
the male sex. In the proposed rule, we proposed to add these ICD-10-CM
diagnosis codes to the Diagnoses for Males Only edit code list under
the Sex Conflict edit.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
N35.016................... Post-traumatic urethral stricture, male,
overlapping sites.
N35.116................... Postinfective urethral stricture, not
elsewhere classified, male, overlapping
sites.
N35.811................... Other urethral stricture, male, meatal.
N35.812................... Other urethral bulbous stricture, male.
N35.813................... Other membranous urethral stricture, male.
N35.814................... Other anterior urethral stricture, male,
anterior.
N35.816................... Other urethral stricture, male, overlapping
sites.
N35.819................... Other urethral stricture, male, unspecified
site.
N35.911................... Unspecified urethral stricture, male,
meatal.
N35.912................... Unspecified bulbous urethral stricture,
male.
N35.913................... Unspecified membranous urethral stricture,
male.
N35.914................... Unspecified anterior urethral stricture,
male.
N35.916................... Unspecified urethral stricture, male,
overlapping sites.
N35.919................... Unspecified urethral stricture, male,
unspecified site.
N99.116................... Postprocedural urethral stricture, male,
overlapping sites.
R93.811................... Abnormal radiologic findings on diagnostic
imaging of right testicle.
R93.812................... Abnormal radiologic findings on diagnostic
imaging of left testicle.
R93.813................... Abnormal radiologic findings on diagnostic
imaging of testicles, bilateral.
R93.819................... Abnormal radiologic findings on diagnostic
imaging of unspecified testicle.
------------------------------------------------------------------------
We also proposed to continue to include the existing diagnosis
codes currently listed under the Diagnoses for Males Only edit code
list.
Comment: Commenters supported the proposal to add the ICD-10-CM
diagnosis codes listed in the table above to the Diagnoses for Males
Only edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add the ICD-10-CM diagnosis codes listed in
the table above to the Diagnoses for Males Only edit code list. We also
are finalizing our proposal to maintain the existing list of codes on
the Diagnoses for Males Only edit code list under the ICD-10 MCE
Version 36, effective October 1, 2018.
c. Manifestation Code as Principal Diagnosis Edit
In the ICD-10-CM classification system, manifestation codes
describe the manifestation of an underlying disease, not the disease
itself and, therefore, should not be used as a principal diagnosis.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20232), we noted
that, as discussed in section II.F.15. of the preamble of the proposed
rule, Table 6A.--New Diagnosis Codes associated with the proposed rule
(which is available via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) listed the new diagnosis codes that had
been approved to date which will be effective with discharges
[[Page 41225]]
occurring on and after October 1, 2018. Included in this table are ICD-
10-CM diagnosis codes K82.A1 (Gangrene of gallbladder in cholecystitis)
and K82.A2 (Perforation of gallbladder in cholecystitis). We proposed
to add these two ICD-10-CM diagnosis codes to the Manifestation Code as
Principal Diagnosis edit code list because the type of cholecystitis
would be required to be reported first. We also proposed to continue to
include the existing diagnosis codes currently listed under the
Manifestation Code as Principal Diagnosis edit code list. We invited
public comments on our proposals.
Comment: Commenters supported the proposal to add ICD-10-CM
diagnosis codes K82.A1 and K82.A2 to the Manifestation Code as
Principal Diagnosis edit code list and to continue to include the
existing diagnosis codes currently listed under the Manifestation Code
as Principal Diagnosis edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add ICD-10-CM diagnosis codes K82.A1 and
K82.A2 to the Manifestation Code as Principal Diagnosis edit code list
and to continue to include the existing diagnosis codes currently
listed under the Manifestation Code as Principal Diagnosis edit code
list under the ICD-10 MCE Version 36, effective October 1, 2018.
d. Questionable Admission Edit
In the MCE, some diagnoses are not usually sufficient justification
for admission to an acute care hospital. For example, if a patient is
assigned ICD-10-CM diagnosis code R03.0 (Elevated blood pressure
reading, without diagnosis of hypertension), the patient would have a
questionable admission because an elevated blood pressure reading is
not normally sufficient justification for admission to a hospital.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20233), we noted
that, as discussed in section II.F.10. of the preamble of the proposed
rule, we were proposing several modifications to the MS-DRGs under MDC
14 (Pregnancy, Childbirth and the Puerperium). We stated in the
proposed rule that one aspect of these proposed modifications involves
the GROUPER logic for the cesarean section and vaginal delivery MS-
DRGs. We referred readers to section II.F.10. of the preamble of the
proposed rule for a detailed discussion of the proposals regarding
these MS-DRG modifications under MDC 14 and the relation to the MCE.
If a patient presents to the hospital and either a cesarean section
or a vaginal delivery occurs, it is expected that, in addition to the
specific type of delivery code, an outcome of delivery code is also
assigned and reported on the claim. The outcome of delivery codes are
ICD-10-CM diagnosis codes that are to be reported as secondary
diagnoses as instructed in Section I.C.15.b.5 of the ICD-10-CM Official
Guidelines for Coding and Reporting which states: ``A code from
category Z37, Outcome of delivery, should be included on every maternal
record when a delivery has occurred. These codes are not to be used on
subsequent records or on the newborn record.'' Therefore, to encourage
accurate coding and appropriate MS-DRG assignment in alignment with the
proposed modifications to the delivery MS-DRGs, we proposed to create a
new ``Questionable Obstetric Admission Edit'' under the Questionable
Admission edit to read as follows:
``b. Questionable obstetric admission
ICD-10-PCS procedure codes describing a cesarean section or vaginal
delivery are considered to be a questionable admission except when
reported with a corresponding secondary diagnosis code describing
the outcome of delivery.
Procedure code list for cesarean section
10D00Z0 Extraction of Products of Conception, High, Open Approach
10D00Z1 Extraction of Products of Conception, Low, Open Approach
10D00Z2 Extraction of Products of Conception, Extraperitoneal, Open
Approach
Procedure code list for vaginal delivery
10D07Z3 Extraction of Products of Conception, Low Forceps, Via
Natural or Artificial Opening
10D07Z4 Extraction of Products of Conception, Mid Forceps, Via
Natural or Artificial Opening
10D07Z5 Extraction of Products of Conception, High Forceps, Via
Natural or Artificial Opening
10D07Z6 Extraction of Products of Conception, Vacuum, Via Natural or
Artificial Opening
10D07Z7 Extraction of Products of Conception, Internal Version, Via
Natural or Artificial Opening
10D07Z8 Extraction of Products of Conception, Other, Via Natural or
Artificial Opening
10D17Z9 Manual Extraction of Products of Conception, Retained, Via
Natural or Artificial Opening
10D18Z9 Manual Extraction of Products of Conception, Retained, Via
Natural or Artificial Opening Endoscopic
10E0XZZ Delivery of Products of Conception, External Approach
Secondary diagnosis code list for outcome of delivery
Z37.0 Single live birth
Z37.1 Single stillbirth
Z37.2 Twins, both liveborn
Z37.3 Twins, one liveborn and one stillborn
Z37.4 Twins, both stillborn
Z37.50 Multiple births, unspecified, all liveborn
Z37.51 Triplets, all liveborn
Z37.52 Quadruplets, all liveborn
Z37.53 Quintuplets, all liveborn
Z37.54 Sextuplets, all liveborn
Z37.59 Other multiple births, all liveborn
Z37.60 Multiple births, unspecified, some liveborn
Z37.61 Triplets, some liveborn
Z37.62 Quadruplets, some liveborn
Z37.63 Quintuplets, some liveborn
Z37.64 Sextuplets, some liveborn
Z37.69 Other multiple births, some liveborn
Z37.7 Other multiple births, all stillborn
Z37.9 Outcome of delivery, unspecified''
We proposed that the three ICD-10-PCS procedure codes listed in the
following table would be used to establish the list of codes for the
proposed Questionable Obstetric Admission edit logic for cesarean
section.
ICD-10-PCS Procedure Codes for Cesarean Section Under the Proposed
Questionable Obstetric Admission Edit Code List in the MCE
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
10D00Z0................... Extraction of products of conception, high,
open approach.
10D00Z1................... Extraction of products of conception, low,
open approach.
10D00Z2................... Extraction of products of conception,
extraperitoneal, open approach.
------------------------------------------------------------------------
We proposed that the nine ICD-10-PCS procedure codes listed in the
following table would be used to establish the list of codes for the
proposed new Questionable Obstetric
[[Page 41226]]
Admission edit logic for vaginal delivery.
ICD-10-PCS Procedure Codes for Vaginal Delivery Under the Proposed
Questionable Obstetric Admission Edit Code List in the MCE
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
10D07Z3................... Extraction of products of conception, low
forceps, via natural or artificial opening.
10D07Z4................... Extraction of products of conception, mid
forceps, via natural or artificial opening.
10D07Z5................... Extraction of products of conception, high
forceps, via natural or artificial opening.
10D07Z6................... Extraction of products of conception,
vacuum, via natural or artificial opening.
10D07Z7................... Extraction of products of conception,
internal version, via natural or artificial
opening.
10D07Z8................... Extraction of products of conception, other,
via natural or artificial opening.
10D17Z9................... Manual extraction of products of conception,
retained, via natural or artificial
opening.
10D18Z9................... Manual extraction of products of conception,
retained, via natural or artificial
opening.
10E0XZZ................... Delivery of products of conception, external
approach.
------------------------------------------------------------------------
We proposed that the 19 ICD-10-CM diagnosis codes listed in the
following table would be used to establish the list of secondary
diagnosis codes for the proposed new Questionable Obstetric Admission
edit logic for outcome of delivery.
ICD-10-CM Secondary Diagnosis Codes for Outcome of Delivery Under the
Proposed Questionable Obstetric Admission Edit Code List in the MCE
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Z37.0..................... Single live birth.
Z37.1..................... Single stillbirth.
Z37.2..................... Twins, both liveborn.
Z37.3..................... Twins, one liveborn and one stillborn.
Z37.4..................... Twins, both stillborn.
Z37.50.................... Multiple births, unspecified, all liveborn.
Z37.51.................... Triplets, all liveborn.
Z37.52.................... Quadruplets, all liveborn.
Z37.53.................... Quintuplets, all liveborn.
Z37.54.................... Sextuplets, all liveborn.
Z37.59.................... Other multiple births, all liveborn.
Z37.60.................... Multiple births, unspecified, some liveborn.
Z37.61.................... Triplets, some liveborn.
Z37.62.................... Quadruplets, some liveborn.
Z37.63.................... Quintuplets, some liveborn.
Z37.64.................... Sextuplets, some liveborn.
Z37.69.................... Other multiple births, some liveborn.
Z37.7..................... Other multiple births, all liveborn.
Z37.9..................... Outcome of delivery, unspecified.
------------------------------------------------------------------------
Comment: Commenters supported creating the new Questionable
Obstetric Admission edit. Commenters also supported the list of
diagnoses and procedure codes that we proposed to include for the
proposed new edit. However, a few commenters expressed concern with
several of the procedure codes that were proposed for inclusion under
the vaginal delivery procedure code list. Specifically, the commenters
identified that ICD-10-PCS procedure codes 10D17Z9 and 10D18Z9 may be
reported for other clinical indications, in the absence of an outcome
of delivery diagnosis code. Therefore, the commenter stated that the
edit would be triggered erroneously for those case scenarios.
Response: We appreciate the commenters' support. We reviewed the
procedure codes for which the commenters expressed concern under the
vaginal delivery procedure code list (ICD-10-PCS procedure codes
10D17Z9 and 10D18Z9) and agree that there may be instances in which the
procedure codes could be reported in the absence of an outcome of
delivery diagnosis code. Therefore, we believe it is appropriate to
remove these two procedure codes from the vaginal delivery procedure
code list for the edit. In addition, we reviewed ICD-10-PCS procedure
codes 10D07Z6 and 10D07Z8 and believe the procedures could potentially
be performed for other clinical indications, in the absence of an
outcome of delivery code, and erroneously trigger the proposed edit if
reported.
After consideration of the public comments we received, we are
finalizing our proposal to create the new Questionable Obstetric
Admission edit. We also are finalizing our proposal to include ICD-10-
PCS procedure codes 10D00Z0, 10D00Z1, and 10D00Z2 listed above for the
``Procedure code list for cesarean section'' portion of the edit. We
are finalizing our proposal to include the procedure codes listed above
for vaginal delivery with modifications. Specifically, we are not
including ICD-10-PCS procedure codes 10D07Z6, 10D07Z87, 10D17Z9 and
10D18Z9 in the ``Procedure code list for vaginal delivery'' portion of
the edit and finalizing the inclusion of the remaining
[[Page 41227]]
procedure codes listed above. In addition, we are finalizing our
proposal to include the diagnosis codes listed above under the
``Secondary diagnosis code list for outcome of delivery'' portion of
the edit. We are finalizing these changes as described above under the
ICD-10 MCE Version 36, effective October 1, 2018.
e. Unacceptable Principal Diagnosis Edit
In the MCE, there are select codes that describe a circumstance
which influences an individual's health status, but does not actually
describe a current illness or injury. There also are codes that are not
specific manifestations, but may be due to an underlying cause. These
codes are considered unacceptable as a principal diagnosis. In limited
situations, there are a few codes on the MCE Unacceptable Principal
Diagnosis edit code list that are considered ``acceptable'' when a
specified secondary diagnosis is also coded and reported on the claim.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20234), we noted
that, as discussed in section II.F.9. of the preamble of the proposed
rule, ICD-10-CM diagnosis codes Z49.02 (Encounter for fitting and
adjustment of peritoneal dialysis catheter), Z49.31 (Encounter for
adequacy testing for hemodialysis), and Z49.32 (Encounter for adequacy
testing for peritoneal dialysis) are currently on the Unacceptable
Principal Diagnosis edit code list. We proposed to add diagnosis code
Z49.01 (Encounter for fitting and adjustment of extracorporeal dialysis
catheter) to the Unacceptable Principal Diagnosis edit code list
because this is an encounter code that would more likely be performed
in an outpatient setting.
Comment: Some commenters supported the proposal to add ICD-10-CM
diagnosis code Z49.01 to the Unacceptable Principal Diagnosis edit code
list. However, some commenters recommended that CMS reconsider the
proposal. These commenters did not dispute the fact that this code is
more likely to be reported in the outpatient setting. However, they
stated that the proposal to add it to the edit appeared to conflict
with the proposal that was discussed in section II.F.9. for MDC 11
(Diseases and Disorders of the Kidney and Urinary Tract) and MS-DRG 685
(Admit for Renal Dialysis). According to the commenters, CMS proposed
to only reassign diagnosis code Z49.01 as a principal diagnosis in the
proposal to delete MS-DRG 685 and reassign diagnosis code Z49.01 to MS-
DRGs 698, 699 and 700.
Response: We appreciate the commenters' support. With regard to the
commenters who recommended that we reconsider the proposal to add
diagnosis code Z49.01 to the Unacceptable Principal Diagnoses edit code
list, we believe there is some confusion with respect to the proposal
that was discussed in section II.F.9. of the preamble of the proposed
rule. The proposal was to reassign diagnosis codes Z49.01, Z49.02,
Z49.31 and Z49.32 to MS-DRGs 698, 699 and 700 (Other Kidney and Urinary
Tract Diagnoses with MCC, with CC and without CC/MCC, respectively)
with the proposed deletion of MS-DRG 685. We are unable to determine
what aspect of the proposal that was discussed in section II.F. 9. of
the preamble of the proposed rule was unclear. For example, it is not
clear if the commenters' confusion relates to the GROUPER logic for MS-
DRGs 698, 699, and 700 as shown in the ICD-10 MS-DRG Definitions
Manual. As discussed elsewhere in this final rule, in the ICD-10 MS-DRG
Definitions Manual, diagnosis codes listed under the heading of
``Principal Diagnosis'' may appear to indicate that those codes are to
be reported as a principal diagnosis for assignment to the respective
MS-DRG. However, the Definitions Manual display of the GROUPER logic
assignment for each diagnosis code is for grouping purposes only and
does not correspond to coding guidelines for reporting the principal
diagnosis. In other words, cases will group according to the GROUPER
logic, regardless of any coding guidelines or coverage policies. It is
the MCE and other payer-specific edits that identify inconsistencies in
the coding guidelines or coverage policies.
We also noted in the proposed rule that, as discussed in section
II.F.15. of the preamble of the proposed rule, Table 6C.--Invalid
Diagnosis Codes associated with the proposed rule (which is available
via the internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html)
listed the diagnosis codes that will no longer be effective as of
October 1, 2018. As previously noted, included in this table is an ICD-
10-CM diagnosis code Z13.4 (Encounter for screening for certain
developmental disorders in childhood) which is currently listed on the
Unacceptable Principal Diagnoses edit code list. We proposed to remove
this code from the Unacceptable Principal Diagnosis edit code list.
We also proposed to continue to include the other existing
diagnosis codes currently listed under the Unacceptable Principal
Diagnosis edit code list.
Comment: Commenters supported the proposal to remove ICD-10-CM
diagnosis code Z13.4 from the Unacceptable Principal diagnoses category
edit code list because it will be an invalid code effective October 1,
2018.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to add ICD-10-CM diagnosis code Z49.01 to the
Unacceptable Principal Diagnosis edit code list. We also are finalizing
our proposal to remove ICD-10-CM diagnosis code Z13.4 from the
Unacceptable Principal Diagnosis edit code list. In addition, we are
finalizing our proposal to maintain the other existing codes on the
Unacceptable Principal Diagnosis edit code list under the ICD-10 MCE
Version 36, effective October 1, 2018.
Comment: One commenter requested that CMS review a coverage edit in
the MCE manual and software. According to the commenter, CMS began
covering multiple myeloma on January 1, 2016 under the condition of
coverage with evidence development (CED) as shown in guidance located
at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/allo-MM.html. The commenter noted that the applicable
procedure codes along with diagnosis codes C90.00 (Multiple myeloma not
having achieved remission) and C90.01 (Multiple myeloma in remission)
are listed as ``non-covered'' in the MCE manual and encouraged CMS to
review further and make any necessary updates as needed to ensure
claims are processed appropriately.
Response: We thank the commenter for bringing this to our
attention. Upon review, guidance was issued on January 27, 2016 for
allogeneic hematopoietic stem cell transplant (HSCT) for certain
Medicare beneficiaries with multiple myeloma under CED. This guidance
is available via the internet on the CMS website at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/allo-MM.html. We agree with the commenter and, therefore, are removing the
following noncovered procedure edit from the ICD-10 MCE Version 36
manual, effective October 1, 2018:
``E. Non-covered procedure codes
The procedures shown below are identified as non-covered procedures
only when any code from the diagnoses list shown below is present as
either a principal or secondary diagnosis.
[[Page 41228]]
Procedures
30230G2 Transfuse Allo Rel Bone Marrow in Periph Vein, Open
30230G3 Transfuse Allo Unr Bone Marrow in Periph Vein, Open
30230G4 Transfuse Allo Unsp Bone Marrow in Periph Vein, Open
30230Y2 Transfuse Allo Rel Hemat Stem Cell in Periph Vein, Open
30230Y3 Transfuse Allo Unr Hemat Stem Cell in Periph Vein, Open
30230Y4 Transfuse Allo Unsp Hemat Stem Cell in Periph Vein, Open
30233G2 Transfuse Allo Rel Bone Marrow in Periph Vein, Perc
30233G3 Transfuse Allo Unr Bone Marrow in Periph Vein, Perc
30233G4 Transfuse Allo Unsp Bone Marrow in Periph Vein, Perc
30233Y2 Transfuse Allo Rel Hemat Stem Cell in Periph Vein, Per
30233Y3 Transfuse Allo Unr Hemat Stem Cell in Periph Vein, Perc
30233Y4 Transfuse Allo Unsp Hemat Stem Cell in Periph Vein, Perc
30240G2 Transfuse Allo Rel Bone Marrow in Central Vein, Open
30240G3 Transfuse Allo Unr Bone Marrow in Central Vein, Open
30240G4 Transfuse Allo Unsp Bone Marrow in Central Vein, Open
30240Y2 Transfuse Allo Rel Hemat Stem Cell in Central Vein, Open
30240Y3 Transfuse Allo Unr Hemat Stem Cell in Central Vein, Open
30240Y4 Transfuse Allo Unsp Hemat Stem Cell in Central Vein, Open
30243G2 Transfuse Allo Rel Bone Marrow in Central Vein, Perc
30243G3 Transfuse Allo Unr Bone Marrow in Central Vein, Perc
30243G4 Transfuse Allo Unsp Bone Marrow in Central Vein, Perc
30243Y2 Transfuse Allo Rel Hemat Stem Cell in Central Vein, Perc
30243Y3 Transfuse Allo Unr Hemat Stem Cell in Central Vein, Perc
30243Y4 Transfuse Allo Unsp Hemat Stem Cell in Central Vein, Perc
30250G1 Transfuse Nonaut Bone Marrow in Periph Art, Open
30250Y1 Transfuse Nonaut Hemat Stem Cell in Periph Art, Open
30253G1 Transfuse Nonaut Bone Marrow in Periph Art, Perc
30253Y1 Transfuse Nonaut Hemat Stem Cell in Periph Art, Perc
30260G1 Transfuse Nonaut Bone Marrow in Central Art, Open
30260Y1 Transfuse Nonaut Hemat Stem Cell in Central Art, Open
30263G1 Transfuse Nonaut Bone Marrow in Central Art, Perc
30263Y1 Transfuse Nonaut Hemat Stem Cell in Central Art, Perc
Diagnoses
C9000 Multiple myeloma not having achieved remission
C9001 Multiple myeloma in remission''
This update will also be reflected in the ICD-10 MCE software
Version 36 effective October 1, 2018.
f. Future Enhancement
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38053 through
38054), we noted the importance of ensuring accuracy of the coded data
from the reporting, collection, processing, coverage, payment, and
analysis aspects. We have engaged a contractor to assist in the review
of the limited coverage and noncovered procedure edits in the MCE that
may also be present in other claims processing systems that are
utilized by our MACs. The MACs must adhere to criteria specified within
the National Coverage Determinations (NCDs) and may implement their own
edits in addition to what are already incorporated into the MCE,
resulting in duplicate edits. The objective of this review is to
identify where duplicate edits may exist and to determine what the
impact might be if these edits were to be removed from the MCE.
We have noted that the purpose of the MCE is to ensure that errors
and inconsistencies in the coded data are recognized during Medicare
claims processing. In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20235), we indicated that we are considering whether the inclusion of
coverage edits in the MCE necessarily aligns with that specific goal
because the focus of coverage edits is on whether or not a particular
service is covered for payment purposes and not whether it was coded
correctly.
As we continue to evaluate the purpose and function of the MCE with
respect to ICD-10, we encourage public input for future discussion. As
we discussed in the FY 2018 IPPS/LTCH PPS final rule, we recognize a
need to further examine the current list of edits and the definitions
of those edits. We continue to encourage public comments on whether
there are additional concerns with the current edits, including
specific edits or language that should be removed or revised, edits
that should be combined, or new edits that should be added to assist in
detecting errors or inaccuracies in the coded data. Comments should be
directed to the MS-DRG Classification Change Mailbox located at:
[email protected] by November 1, 2018 for FY 2020.
14. 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.
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 in
this final rule.
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
[[Page 41229]]
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 proposed to make in the FY 2019 IPPS/
LTCH PPS proposed rule, as discussed in section II.F.10. of the
preamble of this final rule, in the FY 2019 IPPS/LTCH PPS proposed rule
(83 FR 20235), we proposed to revise the surgical hierarchy for MDC 14
(Pregnancy, Childbirth & the Puerperium) as follows: In MDC 14, we
proposed to delete MS-DRGs 765 and 766 (Cesarean Section with and
without CC/MCC, respectively) and MS-DRG 767 (Vaginal Delivery with
Sterilization and/or D&C) from the surgical hierarchy. We proposed to
sequence proposed new MS-DRGs 783, 784, and 785 (Cesarean Section with
Sterilization with MCC, with CC and without CC/MCC, respectively) above
proposed new MS-DRGs 786, 787, and 788 (Cesarean Section without
Sterilization with MCC, with CC and without CC/MCC, respectively). We
proposed to sequence proposed new MS-DRGs 786, 787, and 788 (Cesarean
Section without Sterilization with MCC, with CC and without CC/MCC,
respectively) above MS-DRG 768 (Vaginal Delivery with O.R. Procedure
Except Sterilization and/or D&C). We also proposed to sequence proposed
new MS-DRGs 796, 797, and 798 (Vaginal Delivery with Sterilization/D&C
with MCC, with CC and without CC/MCC, respectively) below MS-DRG 768
and above MS-DRG 770 (Abortion with D&C, Aspiration Curettage or
Hysterotomy). Finally, we proposed to sequence proposed new MS-DRGs
817, 818, and 819 (Other Antepartum Diagnoses with O.R. procedure with
MCC, with CC and without CC/MCC, respectively) below MS-DRG 770 and
above MS-DRG 769 (Postpartum and Post Abortion Diagnoses with O.R.
Procedure). Our proposals for Appendix D MS-DRG Surgical Hierarchy by
MDC and MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 36 are
illustrated in the following table.
Proposed Surgical Hierarchy: MDC 14
[Pregnancy, childbirth and the puerperium]
------------------------------------------------------------------------
------------------------------------------------------------------------
Proposed New MS-DRGs 783-785........... Cesarean Section with
Sterilization.
Proposed New MS-DRGs 786-788........... Cesarean Section without
Sterilization.
MS-DRG 768............................. Vaginal Delivery with O.R.
Procedures.
Proposed New MS-DRGs 796-798........... Vaginal Delivery with
Sterilization/D&C.
MS-DRG 770............................. Abortion with D&C, Aspiration
Curettage or Hysterotomy.
Proposed New MS-DRGs 817-819........... Other Antepartum Diagnoses with
O.R. Procedure.
MS-DRG 769............................. Postpartum and Post Abortion
Diagnoses with O.R. Procedure.
------------------------------------------------------------------------
Comment: Commenters supported the proposed additions, deletions,
and sequencing for the surgical hierarchy under MDC 14.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposed changes to Appendix D MS-DRG Surgical Hierarchy
by MDC and MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 36 as
illustrated in the table above effective October 1, 2018.
As with other MS-DRG related issues, we encourage commenters to
submit requests to examine ICD-10 claims pertaining to the surgical
hierarchy via the CMS MS-DRG Classification Change Request Mailbox
located at: [email protected] by November 1, 2018
for FY 2020 consideration.
15. Changes to the MS-DRG Diagnosis Codes for FY 2019
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
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. Additions and Deletions to the Diagnosis Code Severity Levels for FY
2019
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20236), we
indicated that the following tables identifying the proposed additions
and deletions to the MCC severity levels list and the proposed
additions and deletions to the CC severity levels list for FY 2019 were
available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
[[Page 41230]]
Table 6I.1--Proposed Additions to the MCC List--FY 2019;
Table 6I.2--Proposed Deletions to the MCC List--FY 2019;
Table 6J.1--Proposed Additions to the CC List--FY 2019; and
Table 6J.2--Proposed Deletions to the CC List--FY 2019.
We invited public comments on our proposed severity level
designations for the diagnosis codes listed in Table 6I.1. and Table
6J.1. We noted that, for Table 6I.2. and Table 6J.2., the proposed
deletions are a result of code expansions, with the exception of
diagnosis codes B20 and J80, which are the result of proposed severity
level designation changes. Therefore, the diagnosis codes on these
lists will no longer be valid codes, effective FY 2019.
We referred readers to the Tables 6I.1, 6I.2, 6J.1, and 6J.2
associated with the proposed rule, which are available via the internet
on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
Comment: Commenters supported the proposed additions and deletions
for the diagnosis codes, and their corresponding severity level
designations that were listed in Tables 6I.1, 6I.2, 6J.1, and 6J.2.
associated with the FY 2019 IPPS/LTCH PPS proposed rule. However, a few
commenters expressed concern with the proposed severity level
designation change to diagnosis code B20, and recommended CMS conduct
further analysis prior to finalizing any proposals.
Response: We appreciate the commenters' support. We refer readers
to section II.F.16.b. of the preamble of this final rule for the
detailed discussion of public comments related to the proposals and
final statement of policy involving diagnosis codes B20 and J80.
Comment: One commenter disagreed with CMS' proposal to designate
diagnosis codes K35.20 (Acute appendicitis with generalized
peritonitis, without abscess) and T81.44XA (Sepsis following a
procedure, initial encounter) as CC severity levels, and recommended
CMS reconsider the conditions and classify the severity levels as MCCs.
The commenter noted that the predecessor code for diagnosis code K35.20
is diagnosis code K35.2 (Acute appendicitis with generalized
peritonitis), which is classified as a MCC severity level designation.
Therefore, the commenter also believed that diagnosis code K35.20
should be designated as a MCC severity level. Additionally, the
commenter stated that diagnosis code T81.44XA should be classified as
an MCC severity level because sepsis is defined as a life-threatening
organ dysfunction caused by a host response to infection.
Response: While we acknowledge that our process in assigning a
severity level designation for a diagnosis code generally begins with
identifying the designation of the predecessor code assignment, we
believe that any new or revised clinical concepts included in the new
diagnosis codes should also be considered when making a severity level
designation. We reviewed diagnosis codes K35.20 and T81.44XA and our
clinical advisors continue to support the CC severity level designation
of these diagnosis codes. The commenter is correct that, effective
October 1, 2018, diagnosis code K35.20 has been expanded from the
current diagnosis code K35.2. However, we also note that, effective
October 1, 2018, diagnosis code K35.2 has been expanded to create new
diagnosis code K35.21 (Acute appendicitis with generalized peritonitis,
with abscess). In addition, effective October 1, 2018, diagnosis code
K35.3 (Acute appendicitis with localized peritonitis) has been expanded
to create new diagnosis codes K35.30 (Acute appendicitis with localized
peritonitis, without perforation or gangrene), K35.31 (Acute
appendicitis with localized peritonitis and gangrene, without
perforation), K35.32 (Acute appendicitis with perforation and localized
peritonitis, without abscess) and K35.33 (Acute appendicitis with
perforation and localized peritonitis, with abscess). Consistent with
our usual process, in reviewing all of these newly expanded conditions,
our clinical advisors considered the additional clinical concepts now
included with each diagnosis code in evaluating the appropriate
proposed severity level assignments. Our clinical advisors believed
that the new diagnosis codes for acute appendicitis described as ``with
abscess'' or ``with perforation'' were clinically qualified for the MCC
severity level designation, while acute appendicitis ``without
abscess'' or ``without perforation'' were clinically qualified for the
CC severity level designation because cases with abscess or perforation
would be expected to require more clinical resources and time to treat
while those cases ``without abscess'' or ``without perforation'' are
not as severe clinical conditions. As such, we disagree with the
commenter that, based on the designation of its predecessor code alone,
diagnosis code K35.20 should be designated as an MCC severity level
instead of a CC for FY 2019. With regard to diagnosis code T81.44XA,
our clinical advisors maintain that a CC severity level designation is
most appropriate because the new code is clinically consistent with the
predecessor code, T81.4XXA (Infection following a procedure, initial
encounter), which also has a CC severity level designation. Currently,
under Version 35 of the ICD-10 MS-DRGs, diagnosis code T81.4XXA
contains several inclusion terms (conditions for which the code may be
reported), one of which is ``sepsis following a procedure''. Our
clinical advisors do not believe that the creation of a unique
diagnosis code to specifically identify this condition within the
classification introduces a new clinical concept requiring a higher
level of resources. The new diagnosis code provides additional detail
as to the type of infection following a procedure. However, it is
considered to be clinically similar to the current diagnosis code
describing an infection following a procedure. We also note that an
additional five new diagnosis codes describing infections of varying
degrees following a procedure were created for FY 2019 based on the
other inclusion terms that currently exist at diagnosis code T81.4XXA.
As shown in the table below and in Table 6J.1. associated with the
proposed rule, a total of six new diagnosis codes were proposed to be
designated at the CC severity level based on review of the predecessor
code (T81.4XXA), clinical coherence, and resource considerations.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
T81.40XA.................. Infection following a procedure,
unspecified, initial encounter.
T81.41XA.................. Infection following a procedure, superficial
incisional surgical site, initial
encounter.
T81.42XA.................. Infection following a procedure, deep
incisional surgical site, initial
encounter.
T81.43XA.................. Infection following a procedure, organ and
space surgical site, initial encounter.
T81.44XA.................. Sepsis following a procedure, initial
encounter.
T81.49XA.................. Infection following a procedure, other
surgical site, initial encounter.
------------------------------------------------------------------------
[[Page 41231]]
Therefore, for the reasons discussed above, our clinical advisors
continue to support the proposed CC severity level designation for
diagnosis code T81.44XA for FY 2019.
In addition, because these diagnosis codes identified by the
commenter are new, we do not have any claims data for further analysis.
Once we have additional claims data to allow us to conduct further
review, we can continue to examine these conditions to determine if
their impact on resource use is equal to or above the expected value of
a CC severity level designation.
After consideration of the public comments we received, we are
finalizing our proposal to designate diagnosis codes K35.20 and
T81.44XA as CC severity levels. We also are finalizing our other
proposed additions and deletions with their corresponding severity
level designations for FY 2019. We refer readers to Tables 6I.1., 6I.2,
6J.1, and 6J.2. associated with this final rule, which are available
via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
c. Principal Diagnosis Is Its Own CC or MCC
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38060), we provided
the public with notice of our plans to conduct a comprehensive review
of the CC and MCC lists for FY 2019. In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38056 through 38057), we also finalized our proposal to
maintain the existing lists of principal diagnosis codes in Table 6L.--
Principal Diagnosis Is Its Own MCC List and Table 6M.--Principal
Diagnosis Is Its Own CC List for FY 2018, without any changes to the
existing lists, noting our plans to conduct a comprehensive review of
the CC and MCC lists for FY 2019 (82 FR 38060). We stated that having
multiple lists for CC and MCC diagnoses when reported as a principal
and/or secondary diagnosis may not provide an accurate representation
of resource utilization for the MS-DRGs.
We also stated that the purpose of the Principal Diagnosis Is Its
Own CC or MCC Lists was to ensure consistent MS-DRG assignment between
the ICD-9-CM and ICD-10 MS-DRGs. The Principal Diagnosis Is Its Own CC
or MCC Lists were developed for the FY 2016 implementation of the ICD-
10 version of the MS-DRGs to facilitate replication of the ICD-9-CM MS-
DRGs. As part of our efforts to replicate the ICD-9-CM MS-DRGs, we
implemented logic that may have increased the complexity of the MS-DRG
assignment hierarchy and altered the format of the ICD-10 MS-DRG
Definitions Manual. Two examples of workarounds used to facilitate
replication are the proliferation of procedure clusters in the surgical
MS-DRGs and the creation of the Principal Diagnosis Is Its Own CC or
MCC Lists special logic.
The following paragraph was added to the Version 33 ICD-10 MS-DRG
Definitions Manual to explain the use of the Principal Diagnosis Is Its
Own CC or MCC Lists: ``A few ICD-10-CM diagnosis codes express
conditions that are normally coded in ICD-9-CM using two or more ICD-9-
CM diagnosis codes. In the interest of ensuring that the ICD-10 MS-DRGs
Version 33 places a patient in the same DRG regardless whether the
patient record were to be coded in ICD-9-CM or ICD-10-CM/PCS, whenever
one of these ICD-10-CM combination codes is used as principal
diagnosis, the cluster of ICD-9-CM codes that would be coded on an ICD-
9-CM record is considered. If one of the ICD-9-CM codes in the cluster
is a CC or MCC, then the single ICD-10-CM combination code used as a
principal diagnosis must also imply the CC or MCC that the ICD-9-CM
cluster would have presented. The ICD-10-CM diagnoses for which this
implication must be made are listed here.'' Versions 34 and 35 of the
ICD-10 MS-DRG Definitions Manual also include this special logic for
the MS-DRGs.
The Principal Diagnosis Is Its Own CC or MCC Lists were developed
in the absence of ICD-10 coded data by mapping the ICD-9-CM diagnosis
codes to the new ICD-10-CM combination codes. CMS has historically used
clinical judgment combined with data analysis to assign a principal
diagnosis describing a complex or severe condition to the appropriate
DRG or MS-DRG. The initial ICD-10 version of the MS-DRGs replicated
from the ICD-9 version can now be evaluated using clinical judgment
combined with ICD-10 coded data because it is no longer necessary to
replicate MS-DRG assignment across the ICD-9 and ICD-10 versions of the
MS-DRGs for purposes of calculating relative weights. Now that ICD-10
coded data are available, in addition to using the data for calculating
relative weights, ICD-10 data can be used to evaluate the effectiveness
of the special logic for assigning a severity level to a principal
diagnosis, as an indicator of resource utilization. In the FY 2019
IPPS/LTCH PPS proposed rule (83 FR 20237), to evaluate the
effectiveness of the special logic, we conducted analysis of the ICD-10
coded data combined with clinical review to determine whether to
propose to keep the special logic for assigning a severity level to a
principal diagnosis, or to propose to remove the special logic and use
other available means of assigning a complex principal diagnosis to the
appropriate MS-DRG.
In the proposed rule, using claims data from the September 2017
update of the FY 2017 MedPAR file, we employed the following method to
determine the impact of removing the special logic used in the current
Version 35 GROUPER to process claims containing a code on the Principal
Diagnosis Is Its Own CC or MCC Lists. Edits and cost estimations used
for relative weight calculations were applied, resulting in 9,070,073
IPPS claims analyzed for this special logic impact evaluation. We refer
readers to section II.G. of the preamble of this final rule for further
information regarding the methodology for calculation of the relative
weights.
First, we identified the number of cases potentially impacted by
the special logic. We identified 310,184 cases reporting a principal
diagnosis on the Principal Diagnosis Is Its Own CC or MCC lists. Of the
310,184 total cases that reported a principal diagnosis code on the
Principal Diagnosis Is Its Own CC or MCC Lists, 204,749 cases also
reported a secondary diagnosis code at the same severity level or
higher severity level, and therefore the special logic had no impact on
MS-DRG assignment. However, of the 310,184 total cases, there were
105,435 cases that did not report a secondary diagnosis code at the
same severity level or higher severity level, and therefore the special
logic could potentially impact MS-DRG assignment, depending on the
specific severity leveling structure of the base DRG.
Next, we removed the special logic in the GROUPER that is used for
processing claims reporting a principal diagnosis on the Principal
Diagnosis Is Its Own CC or MCC Lists, thereby creating a Modified
Version 35 GROUPER. Using this Modified Version 35 GROUPER, we
reprocessed the 105,435 claims for which the principal diagnosis code
was the sole source of a MCC or CC on the case, to obtain data for
comparison showing the effect of removing the special logic.
After removing the special logic in the Version 35 GROUPER for
processing claims containing diagnosis codes on the Principal Diagnosis
Is Its Own CC or MCC Lists, and reprocessing the claims using the
Modified Version 35 GROUPER software, we found that 18,596 (6 percent)
of the 310,184 cases reporting a principal diagnosis on the Principal
Diagnosis Is Its Own CC or MCC Lists resulted in a different MS-
[[Page 41232]]
DRG assignment. Overall, the number of claims impacted by removal of
the special logic (18,596) represents 0.2 percent of the 9,070,073 IPPS
claims analyzed.
Below we provide a summary of the steps that we followed for the
analysis performed.
Step 1. We analyzed 9,070,073 claims to determine the number of
cases impacted by the special logic.
With Special Logic--9,070,073 Claims Analyzed
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of cases reporting a principal diagnosis from the 310,184
Principal Diagnosis Is Its Own CC/MCC lists (special
logic).................................................
Number of cases reporting an additional CC/MCC secondary 204,749
diagnosis code at or above the level of the designated
severity level of the principal diagnosis..............
Number of cases not reporting an additional CC/MCC 105,435
secondary diagnosis code...............................
------------------------------------------------------------------------
Step 2. We removed special logic from GROUPER and created a
modified GROUPER.
Step 3. We reprocessed 105,435 claims with modified GROUPER.
Without Special Logic--105,435 Claims Analyzed
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of cases reporting a principal diagnosis from the 310,184
Principal Diagnosis Is Its Own CC/MCC lists............
Number of cases resulting in different MS-DRG assignment 18,596
------------------------------------------------------------------------
To estimate the overall financial impact of removing the special
logic from the GROUPER, we calculated the aggregate change in estimated
payment for the MS-DRGs by comparing average costs for each MS-DRG
affected by the change, before and after removing the special logic.
Before removing the special logic in the Version 35 GROUPER, the cases
impacted by the special logic had an estimated average payment of $58
million above the average costs for all the MS-DRGs to which the claim
was originally assigned. After removing the special logic in the
Version 35 GROUPER, the 18,596 cases impacted by the special logic had
an estimated average payment of $39 million below the average costs for
the newly assigned MS-DRGs.
We performed regression analysis to compare the proportion of
variance in the MS-DRGs with and without the special logic. The results
of the regression analysis showed a slight decrease in variance when
the logic was removed. While the decrease itself was not statistically
significant (an R-squared of 36.2603 percent after the special logic
was removed, compared with an R-squared of 36.2501 percent in the
current version 35 GROUPER), we note that the proportion of variance
across the MS-DRGs essentially stayed the same, and certainly did not
increase, when the special logic was removed.
We further examined the 18,596 claims that were impacted by the
special logic in the GROUPER for processing claims containing a code on
the Principal Diagnosis Is Its Own CC or MCC Lists. The 18,596 claims
were analyzed by the principal diagnosis code and the MS-DRG assigned,
resulting in 588 principal diagnosis and MS-DRG combinations or
subsets. Of the 588 subsets of cases that utilized the special logic,
556 of the 588 subsets (95 percent) had fewer than 100 cases, 529 of
the 588 subsets (90 percent) had fewer than 50 cases, and 489 of the
588 subsets (83 percent) had fewer than 25 cases.
We examined the 32 subsets of cases (5 percent of the 588 subsets)
that utilized the special logic and had 100 or more cases. Of the 32
subsets of cases, 18 (56 percent) are similar in terms of average costs
and length of stay to the MS-DRG assignment that results when the
special logic is removed, and 14 of the 32 subsets of cases (44
percent) are similar in terms of average costs and length of stay to
the MS-DRG assignment that results when the special logic is utilized.
The table below contains examples of four subsets of cases that
utilize the special logic, comparing average length of stay and average
costs between two MS-DRGs within a base DRG, corresponding to the MS-
DRG assigned when the special logic is removed and the MS-DRG assigned
when the special logic is utilized. All four subsets of cases involve
the principal diagnosis code E11.52 (Type 2 diabetes mellitus with
diabetic peripheral angiopathy with gangrene). There are four subsets
of cases in this example because the records involving the principal
diagnosis code E11.52 are assigned to four different base DRGs, one
medical MS-DRG and three surgical MS-DRGs, depending on the procedure
code(s) reported on the claim. All subsets of cases contain more than
100 claims. In three of the four subsets, the cases are similar in
terms of average length of stay and average costs to the MS-DRG
assignment that results when the special logic is removed, and in one
of the four subsets, the cases are similar in terms of average length
of stay and average costs to the MS-DRG assignment that results when
the special logic is utilized.
As shown in the following table, using ICD-10-CM diagnosis code
E11.52 (Type 2 diabetes mellitus with diabetic peripheral angiopathy
with gangrene) as our example, the data findings show four different
MS-DRG pairs for which code E11.52 was the principal diagnosis on the
claim and where the special logic impacted MS-DRG assignment. For the
first MS-DRG pair, we examined MS-DRGs 240 and 241 (Amputation for
Circulatory System Disorders Except Upper Limb and Toe with CC and
without CC/MCC, respectively). We found 436 cases reporting diagnosis
code E11.52 as the principal diagnosis, with an average length of stay
of 5.5 days and average costs of $11,769. These 436 cases are assigned
to MS-DRG 240 with the special logic utilized, and assigned to MS-DRG
241 with the special logic removed. The total number of cases reported
in MS-DRG 240 was 7,675, with an average length of stay of 8.3 days and
average costs of $17,876. The total number of cases reported in MS-DRG
241 was 778, with an average length of stay of 5.0 days and average
costs of $10,882. The 436 cases are more similar to MS-DRG 241 in terms
of length of stay and average cost and less similar to MS-DRG 240.
For the second MS-DRG pair, we examined MS-DRGs 256 and 257 (Upper
Limb and Toe Amputation for Circulatory System Disorders with CC and
without CC/MCC, respectively). We found 193 cases reporting ICD-10-CM
[[Page 41233]]
diagnosis code E11.52 as the principal diagnosis, with an average
length of stay of 4.2 days and average costs of $8,478. These 193 cases
are assigned to MS-DRG 256 with the special logic utilized, and
assigned to MS-DRG 257 with the special logic removed. The total number
of cases reported in MS-DRG 256 was 2,251, with an average length of
stay of 6.1 days and average costs of $11,987. The total number of
cases reported in MS-DRG 257 was 115, with an average length of stay of
4.6 days and average costs of $7,794. These 193 cases are more similar
to MS-DRG 257 in terms of average length of stay and average costs and
less similar to MS-DRG 256.
For the third MS-DRG pair, we examined MS-DRGs 300 and 301
(Peripheral Vascular Disorders with CC and without CC/MCC,
respectively). We found 185 cases reporting ICD-10-CM diagnosis code
E11.52 as the principal diagnosis, with an average length of stay of
3.6 days and average costs of $5,981. These 185 cases are assigned to
MS-DRG 300 with the special logic utilized, and assigned to MS-DRG 301
with the special logic removed. The total number of cases reported in
MS-DRG 300 was 29,327, with an average length of stay of 4.1 days and
average costs of $7,272. The total number of cases reported in MS-DRG
301 was 9,611, with an average length of stay of 2.8 days and average
costs of $5,263. These 185 cases are more similar to MS-DRG 301 in
terms of average length of stay and average costs and less similar to
MS-DRG 300.
For the fourth MS-DRG pair, we examined MS-DRGs 253 and 254 (Other
Vascular Procedures with CC and without CC/MCC, respectively). We found
225 cases reporting diagnosis code E11.52 as the principal diagnosis,
with an average length of stay of 5.2 days and average costs of
$17,901. These 225 cases are assigned to MS-DRG 253 with the special
logic utilized, and assigned to MS-DRG 254 with the special logic
removed. The total number of cases reported in MS-DRG 253 was 25,714,
with an average length of stay of 5.4 days and average costs of
$18,986. The total number of cases reported in MS-DRG 254 was 12,344,
with an average length of stay of 2.8 days and average costs of
$13,287. Unlike the previous three MS-DRG pairs, these 225 cases are
more similar to MS-DRG 253 in terms of average length of stay and
average costs and less similar to MS-DRG 254.
MS-DRG Pairs for Principal Diagnosis ICD-10-CM Code E11.52 With and Without Special MS-DRG Logic
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 240 and 241--Special logic impacted cases with ICD-10-CM 436 5.5 $11,769
code E11.52 as principal diagnosis.............................
MS-DRG 240--All cases........................................... 7,675 8.3 17,876
MS-DRG 241--All cases........................................... 778 5.0 10,882
MS-DRGs 253 and 254--Special logic impacted cases with ICD-10-CM 225 5.2 17,901
E11.52 as principal diagnosis..................................
MS-DRG 253--All cases........................................... 25,714 5.4 18,986
MS-DRG 254--All cases........................................... 12,344 2.8 13,287
MS-DRGs 256 and 257--Special logic impacted cases with ICD-10-CM 193 4.2 8,478
E11.52 as principal diagnosis..................................
MS-DRG 256--All cases........................................... 2,251 6.1 11,987
MS-DRG 257--All cases........................................... 115 4.6 7,794
MS-DRGs 300 and 301--Special logic impacted cases with ICD-10-CM 185 3.6 5,981
E11.52 as principal diagnosis..................................
MS-DRG 300--All cases........................................... 29,327 4.1 7,272
MS-DRG 301--All cases........................................... 9,611 2.8 5,263
----------------------------------------------------------------------------------------------------------------
Based on our analysis of the data, we stated that we believe that
there may be more effective indicators of resource utilization than the
Principal Diagnosis Is Its Own CC or MCC Lists and the special logic
used to assign clinical severity to a principal diagnosis. As stated in
the proposed rule and earlier in this discussion, it is no longer
necessary to replicate MS-DRG assignment across the ICD-9 and ICD-10
versions of the MS-DRGs. The available ICD-10 data can now be used to
evaluate other indicators of resource utilization.
Therefore, as an initial recommendation from the first phase in our
comprehensive review of the CC and MCC lists, we proposed to remove the
special logic in the GROUPER for processing claims containing a
diagnosis code from the Principal Diagnosis Is Its Own CC or MCC Lists,
and we proposed to delete the tables containing the lists of principal
diagnosis codes, Table 6L.--Principal Diagnosis Is Its Own MCC List and
Table 6M.--Principal Diagnosis Is Its Own CC List, from the ICD-10 MS-
DRG Definitions Manual for FY 2019. We invited public comments on our
proposals.
Comment: Commenters supported the proposed deletion of the
Principal Diagnosis Is Its Own CC or MCC logic. One commenter stated
that the lists were created to facilitate replication of the ICD-9
based MS-DRGs and are an artifact of the ICD-10 transitions. Another
commenter recommended removing some of the conditions that are
currently on the lists but expressed concern that eliminating the logic
completely could impact the ability to measure a patient's severity of
illness. One commenter noted that CMS described its internal
comprehensive review and analysis that were conducted, which provided
some level of insight for the proposal; however, the overarching
comment was that CMS believed there were more effective indicators of
resource utilization. Other commenters disagreed with CMS' proposal to
``globally'' remove the Principal Diagnosis Is Its Own CC or MCC logic.
A few commenters stated that a more detailed analysis, consistent with
the comprehensive CC/MCC analysis approach conducted for severity level
changes, should occur. One commenter recommended that the logic
described as part of the MS-DRG Conversion Project with the MCC and CC
translations from ICD-9 to ICD-10 be considered. Another commenter
acknowledged that CMS is no longer attempting to replicate the ICD-9
based MS-DRG GROUPER logic. However, this commenter noted that the
conditions represented by the ICD-10-CM combination codes are
clinically the
[[Page 41234]]
same conditions that were CCs or MCCs under ICD-9-CM.
Response: We appreciate the commenters' support. With regard to the
commenter who recommended removing some of the conditions that are
currently on the lists but expressed concern that eliminating the logic
completely could impact the ability to measure a patient's severity of
illness, we disagree because, in general, the description of a
diagnosis code itself describes or implies a certain level of severity.
In addition, there are other factors to consider besides the principal
diagnosis when determining severity of illness and resource
utilization. In response to the other commenters who disagreed with our
proposal to remove the Principal Diagnosis Is Its Own CC or MCC logic
and recommended that we perform an analysis consistent with the
comprehensive CC/MCC analysis, we note that such an analysis would not
be conclusive because the purpose of the comprehensive CC/MCC analysis
is to evaluate the impact in resource use for patients with conditions
reported as secondary diagnoses. We believe that the analysis that was
performed and discussed in the proposed rule was appropriate for
assessing if we should maintain the special logic that currently exists
for assigning a severity level to a principal diagnosis, as well as to
assess whether it would be appropriate to propose removing the special
logic and utilize alternate methods to evaluate what should be
considered a complex principal diagnosis for MS-DRG assignment
purposes. As stated in the proposed rule (83 FR 20237), CMS has
historically used clinical judgment combined with data analysis to
assign a principal diagnosis describing a complex or severe condition
to the appropriate MS-DRG. We also note that, as stated in the proposed
rule (83 FR 20238), the findings from our analysis of the 18,596 claims
that were impacted by the special logic in the GROUPER for processing
claims containing a code on the Principal Diagnosis Is Its Own CC or
MCC Lists demonstrated that 556 of the 588 subsets had fewer than 100
cases. The low number of cases means that if the special logic had been
proposed for the first time under ICD-10, 95 percent of the diagnosis
codes that were responsible for 95 percent of the cases using the
special logic would not have met the criteria for proposing a change to
their severity level. With regard to the commenter who stated that the
conditions represented by the ICD-10-CM combination codes are
clinically the same conditions that were CCs or MCCs under ICD-9-CM, we
note that combination diagnosis codes are a feature of the
classification of both ICD-9-CM and ICD-10-CM. The majority of the
combination diagnosis codes in ICD-9-CM are also combination codes in
ICD-10-CM. The current list of ICD-10-CM codes that are included in the
special logic is a result of the fact that the codes were classified
differently in ICD-9-CM than in ICD-10-CM. Diagnoses represented as two
separate codes under ICD-9-CM were represented in a combination code
under ICD-10-CM. Codes that were combination codes in both ICD-9-CM and
ICD-10-CM do not have any special severity logic applied, regardless of
the clinical severity of the conditions described, or the increased use
of resources that could be associated with a particular combination
principal diagnosis. As a result, the categorization of ICD-10-CM codes
into lists wherein the principal diagnosis is its own CC or MCC is
based not on a systematic clinical evaluation of the severity of
illness of patients with these combination diagnosis codes, or on a
systematic evaluation of data containing these combination diagnosis
codes used as principal diagnosis, but on a collection of codes
selected exclusively because there were structural differences between
the classification scheme in ICD-9-CM versus ICD-10-CM. Now that ICD-10
coded data are available, it can be used to evaluate other indicators
of resource utilization, along with clinical judgment.
After consideration of the public comments we received, we are
finalizing our proposal to remove the special logic in the GROUPER for
processing claims containing a code on the Principal Diagnosis Is Its
Own CC or MCC Lists as an initial step in our first phase of the
comprehensive review of the CC and MCC lists. We also are finalizing
our proposal to delete the tables containing the lists of principal
diagnosis codes, Table 6L.--Principal Diagnosis Is Its Own MCC List and
Table 6M.--Principal Diagnosis Is Its Own CC List, from the ICD-10 MS-
DRG Definitions Manual Version 36, effective October 1, 2018.
d. CC Exclusions List for FY 2019
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.
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. We
refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50541
through 50544) for detailed information regarding revisions that were
made to the CC and CC Exclusion Lists under the ICD-9-CM MS-DRGs.
The ICD-10 MS-DRGs Version 35 CC Exclusion List is included as
Appendix C in the ICD-10 MS-DRG Definitions Manual, which is available
via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html, and
includes two lists identified as Part 1 and Part 2. Part 1 is the list
of all diagnosis codes that are defined as a CC or MCC when reported as
a secondary diagnosis. If the code designated as a CC or MCC is allowed
with all principal diagnoses, the phrase ``NoExcl'' (for no exclusions)
follows the CC or MCC designation. For example, ICD-10-CM diagnosis
code A17.83 (Tuberculous neuritis) has this ``NoExcl'' entry. For all
other diagnosis codes on the list, a link is provided to a collection
of diagnosis codes which, when used as the principal diagnosis, would
cause the CC or MCC diagnosis to be considered as a non-CC. Part 2 is
the list of diagnosis codes designated as a MCC only for
[[Page 41235]]
patients discharged alive; otherwise, they are assigned as a non-CC.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20239), for FY
2019, we proposed changes to the ICD-10 MS-DRGs Version 36 CC Exclusion
List. Therefore, we developed Table 6G.1.--Proposed Secondary Diagnosis
Order Additions to the CC Exclusions List--FY 2019; Table 6G.2.--
Proposed Principal Diagnosis Order Additions to the CC Exclusions
List--FY 2019; Table 6H.1.--Proposed Secondary Diagnosis Order
Deletions to the CC Exclusions List--FY 2019; and Table 6H.2.--Proposed
Principal Diagnosis Order Deletions to the CC Exclusions List--FY 2019.
For Table 6G.1, each secondary diagnosis code proposed for addition to
the CC Exclusion List is shown with an asterisk and the principal
diagnoses proposed to exclude the secondary diagnosis code are provided
in the indented column immediately following it. For Table 6G.2, each
of the principal diagnosis codes for which there is a CC exclusion is
shown with an asterisk and the conditions proposed for addition to the
CC Exclusion List that will not count as a CC are provided in an
indented column immediately following the affected principal diagnosis.
For Table 6H.1, each secondary diagnosis code proposed for deletion
from the CC Exclusion List is shown with an asterisk followed by the
principal diagnosis codes that currently exclude it. For Table 6H.2,
each of the principal diagnosis codes is shown with an asterisk and the
proposed deletions to the CC Exclusions List are provided in an
indented column immediately following the affected principal diagnosis.
Tables 6G.1., 6G.2., 6H.1., and 6H.2. associated with the proposed rule
are available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
To identify new, revised and deleted diagnosis and procedure codes,
for FY 2019, we developed Table 6A.--New Diagnosis Codes, Table 6B.--
New Procedure Codes, Table 6C.--Invalid Diagnosis Codes, Table 6D.--
Invalid Procedure Codes, Table 6E.--Revised Diagnosis Code Titles, and
Table 6F.--Revised Procedure Code Titles for the proposed rule and this
final rule.
These tables are not published in the Addendum to the proposed rule
or the final rule but are available via the internet on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html as described in section VI. of the
Addendum to this final rule. As discussed in section II.F.18. of the
preamble of this final rule, 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.
In the FY 2019 IPPS/LTCH PPS proposed rule, we invited public
comments on the MDC and MS-DRG assignments for the new diagnosis and
procedure codes as set forth in Table 6A.--New Diagnosis Codes and
Table 6B.--New Procedure Codes. In addition, we invited public comments
on the proposed severity level designations for the new diagnosis codes
as set forth in Table 6A. and the proposed O.R. status for the new
procedure codes as set forth in Table 6B.
Comment: One commenter addressed the proposed MS-DRG assignment for
ICD-10-CM diagnosis code K35.20 (Acute appendicitis with generalized
peritonitis, without abscess) that was included in Table 6A.--New
Diagnosis Codes associated with the proposed rule. The commenter
included the following codes that describe conditions involving
appendicitis with peritonitis, abscess, perforation and gangrene.
------------------------------------------------------------------------
ICD-10-CM code Code description Proposed MS-DRG
------------------------------------------------------------------------
K35.20..................... Acute appendicitis with 371, 372, 373
generalized peritonitis,
without abscess.
K35.21..................... Acute appendicitis with 338, 339, 340
generalized peritonitis, 371, 372, 373
with abscess.
K35.30..................... Acute appendicitis with 371, 372, 373
localized peritonitis,
without perforation or
gangrene.
K35.31..................... Acute appendicitis with 371, 372, 373
localized peritonitis
and gangrene, without
perforation.
K35.32..................... Acute appendicitis with 338, 339, 340
perforation and 371, 372, 373
localized peritonitis,
without abscess.
K35.33..................... Acute appendicitis with 338, 339, 340
perforation and 371, 372, 373
localized peritonitis,
with abscess.
K35.890.................... Other acute appendicitis 371, 372, 373
without perforation or
gangrene.
K35.891.................... Other acute appendicitis 371, 372, 373
without perforation,
with gangrene.
------------------------------------------------------------------------
The commenter stated that the proposed MS-DRG assignment for
diagnosis code K35.20 is inappropriate and urged CMS to assign
additional MS-DRGs and revise Table 6A. Specifically, the commenter
expressed concern that MS-DRGs 371, 372, and 373 (Major
Gastrointestinal Disorders and Peritoneal Infections with MCC, with CC,
and without CC/MCC, respectively) were the only MS-DRGs assigned to
diagnosis code K35.20 and requested that MS-DRGs 338, 339, and 340
(Appendectomy with Complicated Principal Diagnosis with MCC, with CC,
and without CC/MCC, respectively) also be assigned. The commenter
questioned why CMS only assigned MS-DRGs 371, 372, and 373 for
diagnosis code K35.20 when diagnosis code K35.32 was assigned to MS-
DRGs 338, 339, and 340 in addition to MS-DRGs 371, 372, and 373. The
commenter stated that the FY 2019 ICD-10-CM Tabular List of Diseases
and Injuries indicates that codes at the new subcategory K35.2 include
a ruptured or perforated appendix, which is a complicating diagnosis
and requires additional resources. The commenter expressed concern that
the proposed MS-DRG assignment for diagnosis code K35.20 does not
appropriately reflect the complications of the underlying disease or
resources associated with acute appendicitis with generalized
peritonitis. The commenter also noted that studies of patients admitted
with appendicitis define complicated appendicitis as the presence of
either generalized peritonitis due to perforated appendicitis or
appendicular abscess. The commenter further noted that an appendix may
perforate and cause generalized peritonitis without abscess if the
perforation is walled off from the remainder of the peritoneal cavity
because of its retroperitoneal location or by loops of small intestine
or omentum.
Response: We note that the predecessor code for new diagnosis code
K35.20 is diagnosis code K35.2 (Acute appendicitis with generalized
peritonitis), which is currently assigned
[[Page 41236]]
to MS-DRGs 338, 339, 340, 371, 372, and 373. Diagnosis code K35.2 was
subdivided into diagnosis codes K35.20 and K35.21. In assigning the
proposed MS-DRGs for these new diagnosis codes, we considered the
predecessor code MS-DRG assignment and the descriptions of the new
diagnosis codes. Our clinical advisors determined that diagnosis code
K35.21 ``with abscess'' was more appropriate to assign to MS-DRGs 338,
339, and 340 in addition to MS-DRGs 371, 372, and 373 versus diagnosis
code K35.20 ``without abscess''. The degree and severity of the
peritonitis in a patient with acute appendicitis can vary greatly.
However, not all patients with peritonitis develop an abscess. While we
agree that peritonitis is a serious condition when it develops in a
patient with acute appendicitis, we also believe that, clinically, an
abscess presents an even greater risk of complications that requires
more resources as discussed in section II.F.15.b. of the preamble of
this final rule with regard to the severity level designation.
We also consulted with the staff at the Centers for Disease
Control's (CDC's) National Center for Health Statistics (NCHS) because
NCHS has the lead responsibility for maintaining the ICD-10-CM
diagnosis codes. The NCHS' staff acknowledged the clinical concerns of
the commenter based on the manner in which diagnosis codes K35.2 and
K35.3 were expanded and confirmed that they will consider further
review of these newly expanded codes with respect to the clinical
concepts.
Therefore, we maintain that the proposed MS-DRG assignment for
diagnosis code K35.20 as shown in Table 6A is appropriate. Because the
diagnosis codes that the commenter submitted in its comments are new,
effective October 1, 2018, we do not yet have any claims data. We will
continue to monitor these codes as data become available.
After consideration of the public comments we received, we are
finalizing our proposal to assign diagnosis code K35.20 to MS-DRGs 371,
372, and 373 under the ICD-10 MS-DRGs Version 36, effective October 1,
2018.
Comment: One commenter recommended that the following new diagnosis
codes that were included in Table 6A.--New Diagnosis Codes--FY 2019, be
designated as a CC in the ICD-10-CM classification.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
K61.31......................... Horseshoe abscess.
K61.39......................... Other ischiorectal abscess.
K61.5.......................... Supralevator abscess.
K82.A1......................... Gangrene of gallbladder in
cholecystitis.
O86.00......................... Infection of obstetric surgical wound,
unspecified.
O86.01......................... Infection of obstetric surgical wound,
superficial incisional site.
O86.02......................... Infection of obstetric surgical wound,
deep incisional site.
O86.03......................... Infection of obstetric surgical wound,
organ and space site.
O86.09......................... Infection of obstetric surgical wound,
other surgical site.
------------------------------------------------------------------------
According to the commenter, abscesses, postoperative infections,
and gangrene of gallbladder warrant the CC designation because they are
acute conditions and require antibiotics or surgical treatment and
impact the length of stay. The commenter noted that, currently,
diagnosis codes K61.3 (Ischiorectal abscess) and K61.4
(Intrasphincteric abscess) are designated as CCs. The commenter also
noted that gangrene of gallbladder classifies to acute cholecystitis,
which is a CC, and recommended that the codes listed in the above table
all be designated as CCs.
Response: We appreciate the commenter's feedback on the proposed
severity level designations of the diagnosis codes that were included
in Table 6A.--New Diagnosis Codes--FY 2019. The commenter is correct
that, currently, diagnosis codes K61.3 and K61.4 are designated as CCs.
However, our clinical advisors reviewed diagnosis codes K61.31, K61.39,
and K61.5 and continue to support maintaining the proposed non-CC
designation because they do not agree from a clinical perspective that
these conditions warrant a CC designation or significantly impact
resource utilization as a secondary diagnosis. Specifically, our
clinical advisors believe that these diagnosis codes described
conditions that can range in severity and subsequently, the treatment
that is rendered. With regard to the commenter's statement that
abscesses, postoperative infections, and gangrene of gallbladder
warrant the CC designation because they are acute conditions and
require antibiotics or surgical treatment and impact the length of
stay, we note that there are various types of abscesses and
postoperative infections with varying levels of severity that do not
always warrant surgical intervention.
With regard to the commenter's statement that gangrene of
gallbladder classifies to acute cholecystitis which is a CC, we
acknowledge that, currently, diagnosis code K81.0 (Acute cholecystitis)
is a CC and has an inclusion term for gangrene of gallbladder. However,
the new code description does not include the term ``acute''. Upon
review of code K82.A1, our clinical advisors continue to support
maintaining the proposed non-CC designation because they do not agree
from a clinical perspective that this condition warrants a CC
designation or significantly impacts resource utilization as a
secondary diagnosis as the primary diagnosis likely is a more
significant contributor to resource utilization. With regard to the
codes describing infection of obstetrical wound of varying degrees and
depths, the predecessor code O86.0 (Infection of obstetric wound) is
currently classified as a non-CC and our clinical advisors agreed that,
in the absence of data for the new codes, they are appropriately
designated as non-CCs.
After consideration of the public comments we received, we are
finalizing our proposed severity level assignments for the above listed
diagnosis codes under the ICD-10 MS-DRGs Version 36, effective October
1, 2018.
We also are making available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html the following final tables associated with
this final rule:
Table 6A.--New Diagnosis Codes--FY 2019;
Table 6B.--New Procedure Codes--FY 2019;
Table 6C.--Invalid Diagnosis Codes--FY 2019;
[[Page 41237]]
Table 6D.--Invalid Procedure Codes--FY 2019;
Table 6E.--Revised Diagnosis Code Titles--FY 2019;
Table 6F.--Revised Procedure Code Titles--FY 2019;
Table 6G.1.--Secondary Diagnosis Order Additions to the CC
Exclusions List--FY 2019;
Table 6G.2.--Principal Diagnosis Order Additions to the CC
Exclusions List--FY 2019;
Table 6H.1.--Secondary Diagnosis Order Deletions to the CC
Exclusions List--FY 2019;
Table 6H.2.--Principal Diagnosis Order Deletions to the CC
Exclusions List--FY 2019;
Table 6I.1.--Additions to the MCC List--FY 2019;
Table 6I.2.-Deletions to the MCC List--FY 2019;
Table 6J.1.--Additions to the CC List--FY 2019; and
Table 6J.2.--Deletions to the CC List--FY 2019.
We note that, as discussed in section II.F.15.c. of the preamble of
this final rule, we proposed, and in this final rule are finalizing, to
delete Table 6L. and Table 6M. from the ICD-10 MS-DRG Definitions
Manual for FY 2019.
16. Comprehensive Review of CC List for FY 2019
a. Overview of Comprehensive CC/MCC Analysis
In the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159), we described
our process for establishing three different levels of CC severity into
which we would subdivide the diagnosis codes. The categorization of
diagnoses as an MCC, a CC, or a non-CC was accomplished using an
iterative approach in which each diagnosis was evaluated to determine
the extent to which its presence as a secondary diagnosis resulted in
increased hospital resource use. We refer readers to the FY 2008 IPPS/
LTCH PPS final rule (72 FR 47159) for a complete discussion of our
approach. Since this comprehensive analysis was completed for FY 2008,
we have evaluated diagnosis codes individually when receiving requests
to change the severity level of specific diagnosis codes. However,
given the transition to ICD-10-CM and the significant changes that have
occurred to diagnosis codes since this review, we believe it is
necessary to conduct a comprehensive analysis once again. We have begun
this analysis and will discuss our findings in future rulemaking. We
are currently using the same methodology utilized in FY 2008 and
described below to conduct this analysis.
For each secondary diagnosis, we measured the impact in resource
use for the following three subsets of patients:
(1) Patients with no other secondary diagnosis or with all other
secondary diagnoses that are non-CCs.
(2) Patients with at least one other secondary diagnosis that is a
CC but none that is an MCC.
(3) Patients with at least one other secondary diagnosis that is an
MCC.
Numerical resource impact values were assigned for each diagnosis
as follows:
------------------------------------------------------------------------
Value Meaning
------------------------------------------------------------------------
0................................ Significantly below expected value
for the non-CC subgroup.
1................................ Approximately equal to expected value
for the non-CC subgroup.
2................................ Approximately equal to expected value
for the CC subgroup.
3................................ Approximately equal to expected value
for the MCC subgroup.
4................................ Significantly above the expected
value for the MCC subgroup.
------------------------------------------------------------------------
Each diagnosis for which Medicare data were available was evaluated
to determine its impact on resource use and to determine the most
appropriate CC subclass (non-CC, CC, or MCC) assignment. In order to
make this determination, the average cost for each subset of cases was
compared to the expected cost for cases in that subset. The following
format was used to evaluate each diagnosis:
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Code Diagnosis Cnt1 C1 Cnt2 C2 Cnt3 C3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Count (Cnt) is the number of patients in each subset and C1, C2,
and C3 are a measure of the impact on resource use of patients in each
of the subsets. The C1, C2, and C3 values are a measure of the ratio of
average costs for patients with these conditions to the expected
average cost across all cases. 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 a major CC. The C3
value reflects a patient with at least one other secondary diagnosis
that is a major CC. A value close to 1.0 in the C1 field would suggest
that the code produces the same expected value as a non-CC diagnosis.
That is, average costs for the case are similar to the expected average
costs for that subset and the diagnosis is not expected to increase
resource usage. A higher value in the C1 (or C2 and C3) field suggests
more resource usage is associated with the diagnosis and an increased
likelihood that it is more like a CC or major CC than a non-CC. Thus, 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 the condition is expected to consume resources more
similar to an MCC than a CC or non-CC. For example, a C1 value of 1.8
for a secondary diagnosis means that for the subset of patients who
have the secondary diagnosis and have either no other secondary
diagnosis present, or all the other secondary diagnoses present are
non-CCs, the impact on resource use of the secondary diagnoses is
greater than the expected value for a non-CC by an amount equal to 80
percent of the difference between the expected value of a CC and a non-
CC (that is, the impact on resource use of the secondary diagnosis is
closer to a CC than a non-CC).
These mathematical constructs are used as guides in conjunction
with the judgment of our clinical advisors to classify each secondary
diagnosis reviewed as an MCC, CC or non-CC. Our clinical panel reviews
the resource use impact reports and suggests modifications to the
initial CC subclass assignments when clinically appropriate.
b. Requested Changes to Severity Levels
(1) Human Immunodeficiency Virus [HIV] Disease
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20241), we received a request that we consider changing the severity
level of ICD-10-CM diagnosis code B20 (Human immunodeficiency virus
[HIV] disease) from an MCC to a CC. We used the approach outlined above
to evaluate this request. The table below contains the data that were
evaluated for this request.
[[Page 41238]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
B20 (Human immunodeficiency virus [HIV] disease)........ 2,918 0.9946 8,938 2.1237 11,479 3.0960 MCC CC
--------------------------------------------------------------------------------------------------------------------------------------------------------
We stated in the proposed rule that while the data did not strongly
suggest that the categorization of HIV as an MCC was inaccurate, our
clinical advisors indicated that, for many patients with HIV disease,
symptoms are well controlled by medications. Our clinical advisors
stated that if these patients have an HIV-related complicating disease,
that complicating disease would serve as a CC or an MCC. Therefore,
they advised us that ICD-10-CM diagnosis code B20 is more similar to a
CC than an MCC. Based on the data results and the advice of our
clinical advisors, we proposed to change the severity level of ICD-10-
CM diagnosis code B20 from an MCC to a CC.
Comment: Commenters opposed the proposal to change the severity
level for ICD-10-CM diagnosis code B20 from an MCC to a CC. The
commenters stated that the change should not be made without strong
supporting empirical data, referencing the language in the proposed
rule that indicated that the data did not strongly suggest that the
categorization of HIV as an MCC was inaccurate. One commenter indicated
that patients with CD4 counts of less than 100, or elevated viral
loads, would need more laboratory tests, more imaging, and a higher
level of care even if they are in the hospital for a non-HIV related
condition. This commenter suggested that if diagnosis code B20 is
changed to a CC, CMS develop distinct codes for patients with AIDS
based on their level of CD4 and whether viral loads are suppressed.
Response: While we stated in the proposed rule that the data did
not strongly suggest correlation of a secondary diagnosis code of B20
with a severity level of an MCC was inaccurate, the data also did not
definitively support maintaining a severity level of an MCC. While we
understand that HIV is a serious disease that causes significant
chronic illness and can lead to serious complications, we note that
when a patient is admitted for a non-HIV related condition, our
clinical advisors do not believe that the secondary diagnosis of HIV
would be expected to result in the additional resources associated with
an MCC. As explained in the proposed rule, our clinical advisors
believe that, for many patients with HIV disease, symptoms are well
controlled by medications, and if these patients have an HIV-related
complicating disease, that complicating disease would serve as a CC or
an MCC. For these reasons, our clinical advisors continue to believe
that ICD-10-CM diagnosis code B20 is more accurately characterized as a
CC.
As discussed in section II.F.18. of the preamble of this final
rule, requests for new ICD-10-CM diagnosis codes are discussed at the
ICD-10 Coordination and Maintenance Committee meetings. We refer the
commenter to the National Center for Health Statistics (NCHS) website
at https://www.cdc.gov/nchs/icd/icd10_maintenance.html for further
information regarding these meetings and the process for how to request
code updates.
After consideration of the public comments we received, we are
finalizing our proposal to change the severity level of diagnosis code
of B20 from an MCC to a CC.
(2) Acute Respiratory Distress Syndrome
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20241), we also received a request to change the severity level for
ICD-10-CM diagnosis code J80 (Acute respiratory distress syndrome) from
a CC to a MCC. We used the approach outlined above to evaluate this
request. The following table contains the data that were evaluated for
this request.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
J80 (Acute respiratory distress syndrome)............... 1,840 1.7704 6,818 2.5596 18,376 3.3428 CC MCC
--------------------------------------------------------------------------------------------------------------------------------------------------------
We stated in the proposed rule that the data suggest that the
resources involved in caring for a patient with this condition are 77
percent greater than expected when the patient has either no other
secondary diagnosis present or all the other secondary diagnoses
present are non-CCs. The resources are 56 percent greater than expected
when reported in conjunction with another secondary diagnosis that is a
CC, and 34 percent greater than expected when reported in conjunction
with another secondary diagnosis code that is an MCC. Our clinical
advisors agreed that the resources required to care for a patient with
this secondary diagnosis are consistent with those of an MCC.
Therefore, we proposed to change the severity level of ICD-10-CM
diagnosis code J80 from a CC to an MCC.
Comment: Commenters supported the proposal to change the severity
level of ICD-10-CM diagnosis code J80 from a CC to an MCC.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to change the severity level of ICD-10-CM
diagnosis code J80 from a CC to an MCC.
(3) Encephalopathy
As discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20241), we also received a request to change the severity level for
ICD-10-CM diagnosis code G93.40 (Encephalopathy, unspecified) from an
MCC to a non-CC. The requestor pointed out that the nature of the
encephalopathy or its underlying cause should be coded. The requestor
also noted that unspecified heart failure is a non-CC. We used the
approach outlined earlier to evaluate this request. The following table
contains the data that were evaluated for this request.
[[Page 41239]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
G93.40 (Encephalopathy, unspecified).................... 16,306 1.840 80,222 1.8471 139,066 2.4901 MCC MCC
--------------------------------------------------------------------------------------------------------------------------------------------------------
We stated in the proposed rule that the data suggest that the
resources involved in caring for a patient with this condition are 84
percent greater than expected when the patient has either no other
secondary diagnosis present or all the other secondary diagnoses
present are non-CCs. We stated in the proposed rule that the resources
are 15 percent lower than expected when reported in conjunction with
another secondary diagnosis that is a CC, and 49 percent lower than
expected when reported in conjunction with another secondary diagnosis
code that is an MCC. The sentence should have read as follows: The
resources are 15 percent lower than expected when reported in
conjunction with another secondary diagnosis that is a CC, and 51
percent lower than expected when reported in conjunction with another
secondary diagnosis code that is an MCC. We noted that the pattern
observed in resource use for the condition of unspecified heart failure
(ICD-10-CM diagnosis code I50.9) differs from that of unspecified
encephalopathy. Our clinical advisors reviewed this request and agreed
that, from a clinical standpoint, the resources involved in caring for
a patient with this condition are aligned with those of an MCC.
Therefore, we did not propose a change to the severity level for ICD-
10-CM diagnosis code G93.40.
Comment: Several commenters supported the proposal to maintain the
severity level for ICD-10-CM diagnosis code G93.40 as an MCC. One
commenter opposed the proposal, stating that unspecified encephalopathy
is poorly defined, not all specified encephalopathies are MCCs, and the
MCC status creates an incentive for coding personnel to not pursue
specificity of encephalopathy which could lead to a lower relative
weight.
Response: We appreciate the commenters' support. After reviewing
the rationale provided by the commenter who opposed our proposal, we
concur with the commenter that unspecified encephalopathy is poorly
defined, not all encephalopathies are MCCs, and the MCC status creates
an incentive for coding personnel to not pursue specificity of
encephalopathy. For these reason, our clinical advisors agree that it
is appropriate to change the severity level from an MCC to a CC.
After consideration of the public comments we received, we are
changing the severity level for ICD-10-CM diagnosis code G93.40 from an
MCC to a CC.
(4) End-Stage Heart Failure and Hepatic Encephalopathy
Comment: One commenter stated that ICD-10-CM code I50.84 (End-stage
heart failure) should be assigned the severity level of a CC and that
hepatic encephalopathy should be assigned the severity level of an MCC.
The commenter did not provide the specific ICD-10-CM diagnosis codes
that describe hepatic encephalopathy.
Response: Because ICD-10-CM code I50.84 and the codes that describe
hepatic encephalopathy referred to by the commenter are newly created
codes, we do not yet have data with which to evaluate the commenter's
request. We will consider these diagnosis codes during our ongoing
comprehensive CC/MCC analysis once data become available.
After consideration of the public comment received, we are not
changing the severity level of ICD-10-CM code I50.84 or the ICD-10-CM
codes describing hepatic encephalopathy for FY 2019.
17. Review of Procedure Codes in MS DRGs 981 Through 983 and 987
Through 989
Each year, we review cases assigned to MS-DRGs 981, 982, and 983
(Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) and MS-DRGs 987, 988, and
989 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis with
MCC, with CC, and without CC/MCC, respectively) to determine whether it
would be appropriate to change the procedures assigned among these MS-
DRGs. MS-DRGs 981 through 983 and 987 through 989 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.
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.
Based on the results of our review of the claims data from the
September 2017 update of the FY 2017 MedPAR file, in the FY 2019 IPPS/
LTCH PPS proposed rule (83 FR 20242), we did not propose to move 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.
Comment: One commenter identified two scenarios that involve some
cases that are grouping to MS-DRGs 981 through 983 and MS-DRGs 987
through 989. The commenter stated that these grouping issues should be
addressed by CMS and provided specific examples with a combination of
several codes.
Response: We appreciate the commenter bringing these issues to our
attention. However, we were unable to fully evaluate these scenarios
for consideration in FY 2019. We intend to review and consider these
items for FY 2020 as part of our ongoing analysis of the unrelated
procedure MS-DRGs. As stated in section II.F.1.b. of the preamble of
this final rule, we encourage individuals with comments about MS-DRG
classification issues to submit these comments no later than November 1
of each year so that they can be considered for possible inclusion in
the annual proposed rule.
After consideration of the public comments we received, we are not
[[Page 41240]]
moving 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 for FY 2019.
b. Reassignment of Procedures Among MS-DRGs 981 Through 983 and 987
Through 989
We also review the list of ICD-10-PCS procedures that, when in
combination with their principal diagnosis code, result in assignment
to MS-DRGs 981 through 983, or 987 through 989, to ascertain whether
any of those procedures should be reassigned from one of those two
groups of MS-DRGs to the other group of 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 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.
Based on the results of our review of the September 2017 update of
the FY 2017 MedPAR file, we also proposed to maintain the current
structure of MS-DRGs 981 through 983 and MS-DRGs 987 through 989.
Comment: One commenter recommended that CMS classify the insertion
and revision of intracardiac pacemakers as discussed in section
II.F.4.a. of the proposed rule (83 FR 20204) as extensive O.R.
procedures (MS-DRG 981 through 983). The commenter performed its own
analysis where the results demonstrated the average costs of the
intracardiac pacemakers were higher than the average costs of cases in
MS-DRGs 981 through 983.
Response: We are unclear as to the nature of the commenter's
request, as the intracardiac pacemaker procedure codes are already
designated as extensive O.R. procedures in the GROUPER logic, as
discussed in section II.F.4.a. of the preamble of this final rule
After consideration of the public comments we received, we are
finalizing our proposal to maintain the current structure of MS-DRGs
981 through 983 and MS-DRGs 987 through 989 under the ICD-10 MS-DRGs
Version 36, effective October 1, 2018.
c. Adding Diagnosis or Procedure Codes to MDCs
We received a request recommending that CMS reassign cases for
congenital pectus excavatum (congenital depression of the sternum or
concave chest) when reported with a procedure describing repositioning
of the sternum (the Nuss procedure) from MS-DRGs 981, 982, and 983
(Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) to MS-DRGs 515, 516, and 517
(Other Musculoskeletal System and Connective Tissue O.R. Procedures
with MCC, with CC, and without CC/MCC, respectively). ICD-10-CM
diagnosis code Q67.6 (Pectus excavatum) is reported for this congenital
condition and is currently assigned to MDC 4 (Diseases and Disorders of
the Respiratory System). ICD-10-PCS procedure code 0PS044Z (Reposition
sternum with internal fixation device, percutaneous endoscopic
approach) may be reported to identify the Nuss procedure and is
currently assigned to MDC 8 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue) in MS-DRGs 515, 516, and
517. The requester noted that acquired pectus excavatum (ICD-10-CM
diagnosis code M95.4) groups to MS-DRGs 515, 516, and 517 when reported
with a ICD-10-PCS procedure code describing repositioning of the
sternum and requested that cases involving diagnoses describing
congenital pectus excavatum also group to those MS-DRGs when reported
with a ICD-10-PCS procedure code describing repositioning of the
sternum.
Our analysis of this grouping issue confirmed that, when pectus
excavatum (ICD-10-CM diagnosis code Q67.6) is reported as a principal
diagnosis with a procedure such as the Nuss procedure (ICD-10-PCS
procedure code 0PS044Z), these cases group to MS-DRGs 981, 982, and
983. The reason for this grouping is because whenever there is a
surgical procedure reported on a claim, which is unrelated to the MDC
to which the case was assigned based on the principal diagnosis, it
results in an MS-DRG assignment to a surgical class referred to as
``unrelated operating room procedures.'' In the example provided,
because the ICD-10-CM diagnosis code Q67.6 describing pectus excavatum
is classified to MDC 4 and the ICD-10-PCS procedure code 0PS044Z is
classified to MDC 8, the GROUPER logic assigns this case to the
``unrelated operating room procedures'' set of MS-DRGs.
During our review of ICD-10-CM diagnosis code Q67.6, we also
reviewed additional ICD-10-CM diagnosis codes in the Q65 through Q79
code range to determine if there might be other conditions classified
to MDC 4 that describe congenital malformations and deformities of the
musculoskeletal system. We identified the following six ICD-10-CM
diagnosis codes:
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.7.......................... Pectus carinatum.
Q76.6.......................... Other congenital malformations of ribs.
Q76.7.......................... Congenital malformation of sternum.
Q76.8.......................... Other congenital malformations of bony
thorax.
Q76.9.......................... Congenital malformation of bony thorax,
unspecified.
Q77.2.......................... Short rib syndrome.
------------------------------------------------------------------------
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20243), we
proposed to reassign ICD-10-CM diagnosis code Q67.6, as well as the
additional six ICD-10-CM diagnosis codes above describing congenital
musculoskeletal conditions, from MDC 4 to MDC 8 where other related
congenital conditions that correspond to the musculoskeletal system are
classified, as discussed further below.
We identified other related ICD-10-CM diagnosis codes that are
currently assigned to MDC 8 in categories Q67 (Congenital
musculoskeletal deformities of head, face, spine and chest), Q76
(Congenital malformations of spine and bony thorax), and Q77
(Osteochondrodysplasia with defects of growth of tubular bones and
spine) that are listed in the following table.
[[Page 41241]]
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.0.......................... Congenital facial asymmetry.
Q67.1.......................... Congenital compression facies.
Q67.2.......................... Dolichocephaly.
Q67.3.......................... Plagiocephaly.
Q67.4.......................... Other congenital deformities of skull,
face and jaw.
Q67.5.......................... Congenital deformity of spine.
Q67.8.......................... Other congenital deformities of chest.
Q76.1.......................... Klippel-Feil syndrome.
Q76.2.......................... Congenital spondylolisthesis.
Q76.3.......................... Congenital scoliosis due to congenital
bony malformation.
Q76.411........................ Congenital kyphosis, occipito-atlanto-
axial region.
Q76.412........................ Congenital kyphosis, cervical region.
Q76.413........................ Congenital kyphosis, cervicothoracic
region.
Q76.414........................ Congenital kyphosis, thoracic region.
Q76.415........................ Congenital kyphosis, thoracolumbar
region.
Q76.419........................ Congenital kyphosis, unspecified
region.
Q76.425........................ Congenital lordosis, thoracolumbar
region.
Q76.426........................ Congenital lordosis, lumbar region.
Q76.427........................ Congenital lordosis, lumbosacral
region.
Q76.428........................ Congenital lordosis, sacral and
sacrococcygeal region.
Q76.429........................ Congenital lordosis, unspecified
region.
Q76.49......................... Other congenital malformations of
spine, not associated with scoliosis.
Q76.5.......................... Cervical rib.
Q77.0.......................... Achondrogenesis.
Q77.1.......................... Thanatophoric short stature.
Q77.3.......................... Chondrodysplasia punctate.
Q77.4.......................... Achondroplasia.
Q77.5.......................... Diastrophic dysplasia.
Q77.6.......................... Chondroectodermal dysplasia.
Q77.7.......................... Spondyloepiphyseal dysplasia.
Q77.8.......................... Other osteochondrodysplasia with
defects of growth of tubular bones and
spine.
Q77.9.......................... Osteochondrodysplasia with defects of
growth of tubular bones and spine,
unspecified.
------------------------------------------------------------------------
Next, we analyzed the MS-DRG assignments for the related codes
listed above and found that cases with the following conditions are
assigned to MS-DRGs 551 and 552 (Medical Back Problems with and without
MCC, respectively) under MDC 8.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q76.2.......................... Congenital spondylolisthesis.
Q76.411........................ Congenital kyphosis, occipito-atlanto-
axial region.
Q76.412........................ Congenital kyphosis, cervical region.
Q76.413........................ Congenital kyphosis, cervicothoracic
region.
Q76.414........................ Congenital kyphosis, thoracic region.
Q76.415........................ Congenital kyphosis, thoracolumbar
region.
Q76.419........................ Congenital kyphosis, unspecified
region.
Q76.49......................... Other congenital malformations of
spine, not associated with scoliosis.
------------------------------------------------------------------------
The remaining conditions shown below are assigned to MS-DRGs 564,
565, and 566 (Other Musculoskeletal System and Connective Tissue
Diagnoses with MCC, with CC, and without CC/MCC, respectively) under
MDC 8.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.0.......................... Congenital facial asymmetry.
Q67.1.......................... Congenital compression facies.
Q67.2.......................... Dolichocephaly.
Q67.3.......................... Plagiocephaly.
Q67.4.......................... Other congenital deformities of skull,
face and jaw.
Q67.5.......................... Congenital deformity of spine.
Q67.8.......................... Other congenital deformities of chest.
Q76.1.......................... Klippel-Feil syndrome.
Q76.3.......................... Congenital scoliosis due to congenital
bony malformation.
Q76.425........................ Congenital lordosis, thoracolumbar
region.
Q76.426........................ Congenital lordosis, lumbar region.
Q76.427........................ Congenital lordosis, lumbosacral
region.
Q76.428........................ Congenital lordosis, sacral and
sacrococcygeal region.
[[Page 41242]]
Q76.429........................ Congenital lordosis, unspecified
region.
Q76.5.......................... Cervical rib.
Q77.0.......................... Achondrogenesis.
Q77.1.......................... Thanatophoric short stature.
Q77.3.......................... Chondrodysplasia punctate.
Q77.4.......................... Achondroplasia.
Q77.5.......................... Diastrophic dysplasia.
Q77.6.......................... Chondroectodermal dysplasia.
Q77.7.......................... Spondyloepiphyseal dysplasia.
Q77.8.......................... Other osteochondrodysplasia with
defects of growth of tubular bones and
spine.
Q77.9.......................... Osteochondrodysplasia with defects of
growth of tubular bones and spine,
unspecified.
------------------------------------------------------------------------
As a result of our review, we proposed to reassign ICD-10-CM
diagnosis code Q67.6, as well as the additional six ICD-10-CM diagnosis
codes above describing congenital musculoskeletal conditions, from MDC
4 to MDC 8 in MS-DRGs 564, 565, and 566. Our clinical advisors agreed
with this proposed reassignment because it is clinically appropriate
and consistent with the other related ICD-10-CM diagnosis codes grouped
in the Q65 through Q79 range that describe congenital malformations and
deformities of the musculoskeletal system that are classified under MDC
8 in MS-DRGs 564, 565, and 566. We stated in the propsed rule that by
reassigning ICD-10-CM diagnosis code Q67.6 and the additional six ICD-
10-CM diagnosis codes listed in the table above from MDC 4 to MDC 8,
cases reporting these ICD-10-CM diagnosis codes in combination with the
respective ICD-10-PCS procedure code will reflect a more appropriate
grouping from a clinical perspective because they will now be
classified under a surgical musculoskeletal system related MS-DRG and
will no longer result in an MS-DRG assignment to the ``unrelated
operating room procedures'' surgical class.
In summary, we proposed to reassign ICD-10-CM diagnosis codes
Q67.6, Q67.7, Q76.6, Q76.7, Q76.8, Q76.9, and Q77.2 from MDC 4 to MDC 8
in MS-DRGs 564, 565, and 566 (Other Musculoskeletal System and
Connective Tissue Diagnoses with MCC, with CC, and without CC/MCC,
respectively).
Comment: Commenters supported the proposal to reassign the seven
ICD-10-CM diagnosis codes describing congenital musculoskeletal
conditions from MDC 4 to MDC 8 into MS-DRGs 564, 565 and 566. The
commenters stated that the proposal was reasonable, given the ICD-10-CM
codes and the information provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing the proposal to reassign ICD-10-CM diagnosis codes Q67.6,
Q67.7, Q76.6, Q76.7, Q76.8, Q76.9, and Q77.2 from MDC 4 to MDC 8 in MS-
DRGs 564, 565, and 566 under the ICD-10 MS-DRGs Version 36, effective
October 1, 2018.
We also received a request recommending that CMS reassign cases for
sternal fracture repair procedures from MS-DRGs 981, 982, and 983 and
from MS-DRGs 166, 167 and 168 (Other Respiratory System O.R. Procedures
with MCC, with CC and without CC/MCC, respectively) under MDC 4 to MS-
DRGs 515, 516, and 517 under MDC 8. The requester noted that clavicle
fracture repair procedures with an internal fixation device group to
MS-DRGs 515, 516, and 517 when reported with an ICD-10-CM diagnosis
code describing a fractured clavicle. However, sternal fracture repair
procedures with an internal fixation device group to MS-DRGs 981, 982,
and 983 or MS-DRGs 166, 167 and 168 when reported with an ICD-10-CM
diagnosis code describing a fracture of the sternum. According to the
requestor, because the clavicle and sternum are in the same anatomical
region of the body, it would appear that assignment to MS-DRGs 515,
516, and 517 would be more appropriate for sternal fracture repair
procedures.
The requestor provided the following list of ICD-10-PCS procedure
codes in its request for consideration to reassign to MS-DRGs 515, 516
and 517 when reported with an ICD-10-CM diagnosis code for sternal
fracture.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS000Z........................ Reposition sternum with rigid plate
internal fixation device, open
approach.
0PS004Z........................ Reposition sternum with internal
fixation device, open approach.
0PS00ZZ........................ Reposition sternum, open approach.
0PS030Z........................ Reposition sternum with rigid plate
internal fixation device, percutaneous
approach.
0PS034Z........................ Reposition sternum with internal
fixation device, percutaneous
approach.
------------------------------------------------------------------------
We noted that the above five ICD-10-PCS procedure codes that may be
reported to describe a sternal fracture repair are already assigned to
MS-DRGs 515, 516, and 517 under MDC 8. In addition, ICD-10-PCS
procedure codes 0PS000Z and 0PS030Z are assigned to MS-DRGs 166, 167
and 168 under MDC 4.
As noted in the previous discussion, whenever there is a surgical
procedure reported on a claim, which is unrelated to the MDC to which
the case was assigned based on the principal diagnosis, it results in
an MS-DRG assignment to a surgical class referred to as ``unrelated
operating room procedures.'' In the examples provided by the requestor,
when the ICD-10-CM diagnosis code describing a sternal fracture is
classified under MDC 4 and the ICD-10-PCS procedure code describing a
sternal fracture repair procedure is classified under MDC 8, the
GROUPER logic assigns these cases to the ``unrelated operating room
procedures'' group of MS-DRGs (981, 982, and 983) and when the ICD-10-
CM diagnosis code describing a sternal fracture is classified under MDC
4 and the ICD-10-PCS procedure code
[[Page 41243]]
describing a sternal repair procedure is also classified under MDC 4,
the GROUPER logic assigns these cases to MS-DRG 166, 167, or 168.
For our review of this grouping issue and the request to have
procedures for sternal fracture repairs assigned to MDC 8, we analyzed
the ICD-10-CM diagnosis codes describing a sternal fracture currently
classified under MDC 4. We identified 10 ICD-10-CM diagnosis codes
describing a sternal fracture with an ``initial encounter'' classified
under MDC 4 that are listed in the following table.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
S22.20XA....................... Unspecified fracture of sternum,
initial encounter for closed fracture.
S22.20XB....................... Unspecified fracture of sternum,
initial encounter for open fracture.
S22.21XA....................... Fracture of manubrium, initial
encounter for closed fracture.
S22.21XB....................... Fracture of manubrium, initial
encounter for open fracture.
S22.22XA....................... Fracture of body of sternum, initial
encounter for closed fracture.
S22.22XB....................... Fracture of body of sternum, initial
encounter for open fracture.
S22.23XA....................... Sternal manubrial dissociation, initial
encounter for closed fracture.
S22.23XB....................... Sternal manubrial dissociation, initial
encounter for open fracture.
S22.24XA....................... Fracture of xiphoid process, initial
encounter for closed fracture.
S22.24XB....................... Fracture of xiphoid process, initial
encounter for open fracture.
------------------------------------------------------------------------
Our analysis of this grouping issue confirmed that when 1 of the 10
ICD-10-CM diagnosis codes describing a sternal fracture listed in the
table above from MDC 4 is reported as a principal diagnosis with an
ICD-10-PCS procedure code for a sternal repair procedure from MDC 8,
these cases group to MS-DRG 981, 982, or 983. We also confirmed that
when 1 of the 10 ICD-10-CM diagnosis codes describing a sternal
fracture listed in the table above from MDC 4 is reported as a
principal diagnosis with an ICD-10-PCS procedure code for a sternal
repair procedure from MDC 4, these cases group to MS-DRG 166, 167 or
168.
Our clinical advisors agreed with the requested reclassification of
ICD-10-CM diagnosis codes S22.20XA, S22.20XB, S22.21XA, S22.21XB,
S22.22XA, S22.22XB, S22.23XA, S22.23XB, S22.24XA, and S22.24XB
describing a sternal fracture with an initial encounter from MDC 4 to
MDC 8. They advised that this requested reclassification is clinically
appropriate because it is consistent with the other related ICD-10-CM
diagnosis codes that describe fractures of the sternum and which are
classified under MDC 8. The ICD-10-CM diagnosis codes describing a
sternal fracture currently classified under MDC 8 to MS-DRGs 564, 565,
and 566 are listed in the following table.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
S22.20XD....................... Unspecified fracture of sternum,
subsequent encounter for fracture with
routine healing.
S22.20XG....................... Unspecified fracture of sternum,
subsequent encounter for fracture with
delayed healing.
S22.20XK....................... Unspecified fracture of sternum,
subsequent encounter for fracture with
nonunion.
S22.20XS....................... Unspecified fracture of sternum,
sequela.
S22.21XD....................... Fracture of manubrium, subsequent
encounter for fracture with routine
healing.
S22.21XG....................... Fracture of manubrium, subsequent
encounter for fracture with delayed
healing.
S22.21XK....................... Fracture of manubrium, subsequent
encounter for fracture with nonunion.
S22.21XS....................... Fracture of manubrium, sequela.
S22.22XD....................... Fracture of body of sternum, subsequent
encounter for fracture with routine
healing.
S22.22XG....................... Fracture of body of sternum, subsequent
encounter for fracture with delayed
healing.
S22.22XK....................... Fracture of body of sternum, subsequent
encounter for fracture with nonunion.
S22.22XS....................... Fracture of body of sternum, sequela.
S22.23XD....................... Sternal manubrial dissociation,
subsequent encounter for fracture with
routine healing.
S22.23XG....................... Sternal manubrial dissociation,
subsequent encounter for fracture with
delayed healing.
S22.23XK....................... Sternal manubrial dissociation,
subsequent encounter for fracture with
nonunion.
S22.23XS....................... Sternal manubrial dissociation,
sequela.
S22.24XD....................... Fracture of xiphoid process, subsequent
encounter for fracture with routine
healing.
S22.24XG....................... Fracture of xiphoid process, subsequent
encounter for fracture with delayed
healing.
S22.24XK....................... Fracture of xiphoid process, subsequent
encounter for fracture with nonunion.
S22.24XS....................... Fracture of xiphoid process, sequela.
------------------------------------------------------------------------
We stated in the proposed rule that by reclassifying the 10 ICD-10-
CM diagnosis codes listed in the table earlier in this section
describing sternal fracture codes with an ``initial encounter'' from
MDC 4 to MDC 8, the cases reporting these ICD-10-CM diagnosis codes in
combination with the respective ICD-10-PCS procedure codes will reflect
a more appropriate grouping from a clinical perspective and will no
longer result in an MS-DRG assignment to the ``unrelated operating room
procedures'' surgical class when reported with a surgical procedure
classified under MDC 8.
Therefore, in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20245), we proposed to reassign ICD-10-CM diagnosis codes S22.20XA,
S22.20XB, S22.21XA, S22.21XB, S22.22XA, S22.22XB, S22.23XA, S22.23XB,
S22.24XA, and S22.24XB from under MDC 4 to MDC 8 to MS-DRGs 564, 565,
and 566. We invited public comments on our proposals.
Comment: Commenters supported the proposal to reassign the 10 ICD-
10-CM diagnosis codes describing sternal fractures with an initial
encounter from MDC 4 to MDC 8 into MS-DRGs 564, 565 and 566. The
commenters stated that the proposal was reasonable, given
[[Page 41244]]
the ICD-10-CM codes and the information provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing the proposal to reassign ICD-10-CM diagnosis codes S22.20XA,
S22.20XB, S22.21XA, S22.21XB, S22.22XA, S22.22XB, S22.23XA, S22.23XB,
S22.24XA, and S22.24XB from MDC 4 to MDC 8 to MS-DRGs 564, 565, and 566
under the ICD-10 MS-DRGs Version 36, effective October 1, 2018.
In addition, we received a request recommending that CMS reassign
cases for rib fracture repair procedures from MS-DRGs 981, 982, and
983, and from MS-DRGs 166, 167 and 168 (Other Respiratory System O.R.
Procedures with MCC, with CC, and without CC/MCC, respectively) under
MDC 4 to MS-DRGs 515, 516, and 517 under MDC 8. The requestor noted
that clavicle fracture repair procedures with an internal fixation
device group to MS-DRGs 515, 516, and 517 when reported with an ICD-10-
CM diagnosis code describing a fractured clavicle. However, rib
fracture repair procedures with an internal fixation device group to
MS-DRGs 981, 982, and 983 or to MS-DRGs 166, 167 and 168 when reported
with an ICD-10-CM diagnosis code describing a rib fracture. According
to the requestor, because the clavicle and ribs are in the same
anatomical region of the body, it would appear that assignment to MS-
DRGs 515, 516, and 517 would be more appropriate for rib fracture
repair procedures.
The requestor provided the following list of 10 ICD-10-PCS
procedure codes in its request for consideration for reassignment to
MS-DRGs 515, 516 and 517 when reported with an ICD-10-CM diagnosis code
for rib fracture.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PH104Z................... Insertion of internal fixation device into 1
to 2 ribs, open approach.
0PH134Z................... Insertion of internal fixation device into 1
to 2 ribs, percutaneous approach.
0PH144Z................... Insertion of internal fixation device into 1
to 2 ribs, percutaneous endoscopic
approach.
0PH204Z................... Insertion of internal fixation device into 3
or more ribs, open approach.
0PH234Z................... Insertion of internal fixation device into 3
or more ribs, percutaneous approach.
0PH244Z................... Insertion of internal fixation device into 3
or more ribs, percutaneous endoscopic
approach.
0PS104Z................... Reposition 1 to 2 ribs with internal
fixation device, open approach.
0PS134Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous approach.
0PS204Z................... Reposition 3 or more ribs with internal
fixation, device, open approach.
0PS234Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous approach.
------------------------------------------------------------------------
We note that the above 10 ICD-10-PCS procedure codes that may be
reported to describe a rib fracture repair are already assigned to MS-
DRGs 515, 516, and 517 under MDC 8. In addition, 6 of the 10 ICD-10-PCS
procedure codes listed above (0PH104Z, 0PH134Z, 0PH144Z, 0PH204Z,
0PH234Z and 0PH244Z) are also assigned to MS-DRGs 166, 167, and 168
under MDC 4.
As noted in the previous discussions above, whenever there is a
surgical procedure reported on a claim, which is unrelated to the MDC
to which the case was assigned based on the principal diagnosis, it
results in an MS-DRG assignment to a surgical class referred to as
``unrelated operating room procedures.'' In the examples provided by
the requestor, when the ICD-10-CM diagnosis code describing a rib
fracture is classified under MDC 4 and the ICD-10-PCS procedure code
describing a rib fracture repair procedure is classified under MDC 8,
the GROUPER logic assigns these cases to the ``unrelated operating room
procedures'' group of MS-DRGs (981, 982, and 983) and when the ICD-10-
CM diagnosis code describing a rib fracture is classified under MDC 4
and the ICD-10-PCS procedure code describing a rib repair procedure is
also classified under MDC 4, the GROUPER logic assigns these cases to
MS-DRG 166, 167, or 168.
For our review of this grouping issue and the request to have
procedures for rib fracture repairs assigned to MDC 8, we analyzed the
ICD-10-CM diagnosis codes describing a rib fracture and found that,
while some rib fracture ICD-10-CM diagnosis codes are classified under
MDC 8 (which would result in those cases grouping appropriately to MS-
DRGs 515, 516, and 517), there are other ICD-10-CM diagnosis codes that
are currently classified under MDC 4. We identified the following ICD-
10-CM diagnosis codes describing a rib fracture with an initial
encounter classified under MDC 4, as listed in the following table.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
S2231XA................... Fracture of one rib, right side, initial
encounter for closed fracture.
S2231XB................... Fracture of one rib, right side, initial
encounter for open fracture.
S2232XA................... Fracture of one rib, left side, initial
encounter for closed fracture.
S2232XB................... Fracture of one rib, left side, initial
encounter for open fracture.
S2239XA................... Fracture of one rib, unspecified side,
initial encounter for closed fracture.
S2239XB................... Fracture of one rib, unspecified side,
initial encounter for open fracture.
S2241XA................... Multiple fractures of ribs, right side,
initial encounter for closed fracture.
S2241XB................... Multiple fractures of ribs, right side,
initial encounter for open fracture.
S2242XA................... Multiple fractures of ribs, left side,
initial encounter for closed fracture.
S2242XB................... Multiple fractures of ribs, left side,
initial encounter for open fracture.
S2243XA................... Multiple fractures of ribs, bilateral,
initial encounter for closed fracture.
S2243XB................... Multiple fractures of ribs, bilateral,
initial encounter for open fracture.
S2249XA................... Multiple fractures of ribs, unspecified
side, initial encounter for closed
fracture.
S2249XB................... Multiple fractures of ribs, unspecified
side, initial encounter for open fracture.
S225XXA................... Flail chest, initial encounter for closed
fracture.
S225XXB................... Flail chest, initial encounter for open
fracture.
------------------------------------------------------------------------
[[Page 41245]]
Our analysis of this grouping issue confirmed that, when one of the
following four ICD-10-PCS procedure codes identified by the requestor
(and listed in the table earlier in this section) from MDC 8 (0PS104Z,
0PS134Z, 0PS204Z, or 0PS234Z) is reported to describe a rib fracture
repair procedure with a principal diagnosis code for a rib fracture
with an initial encounter listed in the table above from MDC 4, these
cases group to MS-DRG 981, 982, or 983.
During our review of those four repositioning of the rib procedure
codes, we also identified the following four ICD-10-PCS procedure codes
classified to MDC 8 that describe repositioning of the ribs.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS10ZZ................... Reposition 1 to 2 ribs, open approach.
0PS144Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous endoscopic
approach.
0PS20ZZ................... Reposition 3 or more ribs, open approach.
0PS244Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous endoscopic
approach.
------------------------------------------------------------------------
We confirmed that when one of the above four procedure codes is
reported with a principal diagnosis code for a rib fracture listed in
the table above from MDC 4, these cases also group to MS-DRG 981, 982,
or 983.
Lastly, we confirmed that when one of the six ICD-10-PCS procedure
codes describing a rib fracture repair listed in the previous table
above from MDC 4 is reported with a principal diagnosis code for a rib
fracture with an initial encounter from MDC 4, these cases group to MS-
DRG 166, 167, or 168.
In response to the request to reassign the procedure codes that
describe a rib fracture repair procedure from MS-DRGs 981, 982, and 983
and from MS-DRGs 166, 167, and 168 under MDC 4 to MS-DRGs 515, 516, and
517 under MDC 8, as discussed above, the 10 ICD-10-PCS procedure codes
submitted by the requestor that may be reported to describe a rib
fracture repair are already assigned to MS-DRGs 515, 516, and 517 under
MDC 8 and 6 of those 10 procedure codes (0PH104Z, 0PH134Z, 0PH144Z,
0PH204Z, 0PH234Z, and 0PH244Z) are also assigned to MS-DRGs 166, 167,
and 168 under MDC 4.
We analyzed claims data from the September 2017 update of the FY
2017 MedPAR file for cases reporting a principal diagnosis of a rib
fracture (initial encounter) from the list of diagnosis codes shown in
the table above with one of the six ICD-10-PCS procedure codes
describing the insertion of an internal fixation device into the rib
(0PH104Z, 0PH134Z, 0PH144Z, 0PH204Z, 0PH234Z, and 0PH244Z) in MS-DRGs
166, 167, and 168 under MDC 4. Our findings are shown in the table
below.
MS-DRGs for Other Respiratory System O.R. Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 166-All cases............................................ 22,938 10.2 $24,299
MS-DRG 166-Cases with principal diagnosis of rib fracture(s) and 40 11.4 43,094
insertion of internal fixation device for the rib(s)...........
MS-DRG 167-All cases............................................ 10,815 5.7 13,252
MS-DRG 167-Cases with principal diagnosis of rib fracture(s) and 10 6.7 30,617
insertion of internal fixation device for the rib(s)...........
MS-DRG 168-All cases............................................ 3,242 3.1 9,708
MS-DRG 168-Cases with principal diagnosis of rib fracture(s) and 4 2 21,501
insertion of internal fixation device for the rib(s)...........
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 22,938 cases in MS-
DRG 166, with an average length of stay of 10.2 days and average costs
of $24,299. In MS-DRG 166, we found 40 cases reporting a principal
diagnosis of a rib fracture(s) with insertion of an internal fixation
device for the rib(s), with an average length of stay of 11.4 days and
average costs of $43,094. There were a total of 10,815 cases in MS-DRG
167, with an average length of stay of 5.7 days and average costs of
$13,252. In MS-DRG 167, we found 10 cases reporting a principal
diagnosis of a rib fracture(s) with insertion of an internal fixation
device for the rib(s), with an average length of stay of 6.7 days and
average costs of $30,617. There were a total of 3,242 cases in MS-DRG
168, with an average length of stay of 3.1 days and average costs of
$9,708. In MS-DRG 168, we found 4 cases reporting a principal diagnosis
of a rib fracture(s) with insertion of an internal fixation device for
the rib(s), with an average length of stay of 2 days and average costs
of $21,501. Overall, for MS-DRGs 166, 167, and 168, there were a total
of 54 cases reporting a principal diagnosis of a rib fracture(s) with
insertion of an internal fixation device for the rib(s), demonstrating
that while rib fractures may require treatment, they are not typically
corrected surgically. Our clinical advisors agreed with the current
assignment of procedure codes to MS-DRGs 166, 167, and 168 that may be
reported to describe repair of a rib fracture under MDC 4, as well as
the current assignment of procedure codes to MS-DRGs 515, 516, and 517
that may be reported to describe repair of a rib fracture under MDC 8.
Our clinical advisors noted that initial, acute rib fractures can cause
numerous respiratory related issues requiring various treatments and
problems with the healing of a rib fracture are considered
musculoskeletal issues.
We also noted that the procedure codes submitted by the requestor
may be reported for other indications and they are not restricted to
reporting for repair of a rib fracture. Therefore, assignment of these
codes to the MDC 4 MS-DRGs and the MDC 8 MS-DRGs is clinically
appropriate.
To address the cases reporting procedure codes describing the
[[Page 41246]]
repositioning of a rib(s) that are grouping to MS-DRGs 981, 982, and
983 when reported with a principal diagnosis of a rib fracture (initial
encounter), in the FY 2019 IPPS/LTCH PPS proposed rule, we proposed to
add the following eight ICD-10-PCS procedure codes currently assigned
to MDC 8 into MDC 4, in MS-DRGs 166, 167 and 168.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS104Z................... Reposition 1 to 2 ribs with internal
fixation device, open approach.
0PS10ZZ................... Reposition 1 to 2 ribs, open approach.
0PS134Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous approach.
0PS144Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous endoscopic
approach.
0PS204Z................... Reposition 3 or more ribs with internal
fixation device, open approach.
0PS20ZZ................... Reposition 3 or more ribs, open approach.
0PS234Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous approach.
0PS244Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous endoscopic
approach.
------------------------------------------------------------------------
Our clinical advisors agreed with this proposed addition to the
classification structure because it is clinically appropriate and
consistent with the other related ICD-10-PCS procedure codes that may
be reported to describe rib fracture repair procedures with the
insertion of an internal fixation device and are classified under MDC
4.
We stated in the proposed rule that by adding the eight ICD-10-PCS
procedure codes describing repositioning of the rib(s) that may be
reported to describe a rib fracture repair procedure under the
classification structure for MDC 4, these cases will no longer result
in an MS-DRG assignment to the ``unrelated operating room procedures''
surgical class when reported with a diagnosis code under MDC 4.
Comment: Commenters supported the proposal to add the eight ICD-10-
PCS procedure codes describing repositioning of the ribs to MDC 4 in
MS-DRGs 166, 167 and 168. The commenters stated that the proposal was
reasonable, given the data, the ICD-10-PCS codes and the information
provided.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing the proposal to add ICD-10-PCS procedure codes 0PS104Z,
0PS10ZZ, 0PS134Z, 0PS144Z, 0PS204Z, 0PS20ZZ, 0PS234Z and 0PS244Z
currently assigned to MDC 8 into MDC 4 in MS-DRGs 166, 167 and 168
under the ICD-10 MS-DRGs Version 36, effective October 1, 2018.
18. Changes to the ICD-10-CM and ICD-10-PCS Coding Systems
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 (CDC), and CMS, charged with
maintaining and updating the ICD-9-CM system. The final update to ICD-
9-CM codes was made on October 1, 2013. Thereafter, the name of the
Committee was changed to the ICD-10 Coordination and Maintenance
Committee, effective with the March 19-20, 2014 meeting. The ICD-10
Coordination and Maintenance Committee addresses updates to the ICD-10-
CM and ICD-10-PCS 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 website at: http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/codes.html. The official
list of ICD-10-CM and ICD-10-PCS codes can be found on the CMS website
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 previously mentioned
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 2019 at a public meeting held on September 12-13,
2017, and finalized the coding changes after consideration of comments
received at the meetings and in writing by November 13, 2017.
The Committee held its 2018 meeting on March 6-7, 2018. The
deadline for submitting comments on these code proposals was scheduled
for April 6, 2018. 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 2018
would be included in the October 1, 2018 update to ICD-10-CM/ICD-10-
PCS. As discussed in earlier sections of the preamble of this final
rule, there are new, revised, and deleted ICD-10-CM diagnosis codes and
ICD-10-PCS procedure codes that are captured in Table 6A.--New
Diagnosis Codes, Table 6B.--New Procedure Codes, Table 6C.--Invalid
Diagnosis Codes, Table 6D.--Invalid Procedure Codes, Table 6E.--Revised
Diagnosis Code Titles, and Table 6F.--Revised Procedure Code Titles for
this final rule, which are available via the internet on the CMS
website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. The code titles are adopted as
part of the
[[Page 41247]]
ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee
process. Therefore, although we make the code titles available for the
IPPS proposed rule, they are not subject to comment in the proposed
rule. Because of the length of these tables, they were not published in
the Addendum to the proposed rule. Rather, they are available via the
internet as discussed in section VI. of the Addendum to the proposed
rule.
Live Webcast recordings of the discussions of procedure codes at
the Committee's September 12-13, 2017 meeting and March 6-7, 2018
meeting can be obtained from the CMS website at: http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/icd9ProviderDiagnosticCodes/03_meetings.asp. The minutes of the
discussions of diagnosis codes at the September 12-13, 2017 meeting and
March 6-7, 2018 meeting can be found at: http://www.cdc.gov/nchs/icd/icd10cm_maintenance.html. These websites also provide detailed
information about the Committee, including information on requesting a
new code, attending a Committee meeting, and 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
submitted via 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 diagnosis and procedure 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
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 website. 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 published on the CMS and NCHS websites in June 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 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 requester 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 not
any requests approved for an expedited April 1, 2018 implementation of
a code at the September 12-13, 2017 Committee meeting. Therefore, there
were not any new codes for implementation on April 1, 2018.
ICD-9-CM addendum and code title information is published on the
CMS website at: http://www.cms.hhs.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
website at: http://www.cms.gov/Medicare/Coding/ICD10/index.html. 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.
Information on ICD-10-CM diagnosis codes, along with the Official
ICD-10-CM Coding Guidelines, can also be found on the CDC website at:
http://www.cdc.gov/nchs/icd/icd10.htm. Additionally, information on
new, revised, and deleted ICD-10-CM/ICD-10-PCS codes is provided to the
AHA for publication in the Coding Clinic for ICD-10. AHA also
distributes coding update information to publishers and software
vendors.
[[Page 41248]]
The following chart shows the number of ICD-10-CM and ICD-10-PCS
codes and code changes since FY 2016 when ICD-10 was implemented.
Total Number of Codes and Changes in Total Number of Codes per Fiscal
Year ICD-10-CM and ICD-10-PCS Codes
------------------------------------------------------------------------
Fiscal year Number Change
------------------------------------------------------------------------
FY 2016:
ICD-10-CM............................. 69,823 ..............
ICD-10-PCS............................ 71,974 ..............
FY 2017:
ICD-10-CM............................. 71,486 +1,663
ICD-10-PCS............................ 75,789 +3,815
FY 2018:
ICD-10-CM............................. 71,704 +218
ICD-10-PCS............................ 78,705 +2,916
FY 2019:................................
ICD-10-CM............................. 71,932 +228
ICD-10-PCS............................ 78,881 +176
------------------------------------------------------------------------
As mentioned previously, 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.
At the September 12-13, 2017 and March 6-7, 2018 Committee
meetings, we discussed any requests we had received for new ICD-10-CM
diagnosis codes and ICD-10-PCS procedure codes that were to be
implemented on October 1, 2018. We invited public comments on any code
requests discussed at the September 12-13, 2017 and March 6-7, 2018
Committee meetings for implementation as part of the October 1, 2018
update. The deadline for commenting on code proposals discussed at the
September 12-13, 2017 Committee meeting was November 13, 2017. The
deadline for commenting on code proposals discussed at the March 6-7,
2018 Committee meeting was April 6, 2018.
19. 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 subsequently failed or was recalled determined the base MS-
DRG assignment. At that time, we specified that we will reduce a
hospital's IPPS payment for those MS-DRGs where the hospital received a
credit for a replaced device equal to 50 percent or more of the cost of
the device.
In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51556 through
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. Changes for FY 2019
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20250 through
20251), for FY 2019, we did not propose to add any MS-DRGs to the
policy for replaced devices offered without cost or with a credit. We
proposed to continue to include the existing MS-DRGs currently subject
to the policy as displayed in the table below.
------------------------------------------------------------------------
MDC MS-DRG MS-DRG title
------------------------------------------------------------------------
Pre-MDC........................ 001 Heart Transplant or
Implant of Heart
Assist System with
MCC.
Pre-MDC........................ 002 Heart Transplant or
Implant of Heart
Assist System without
MCC.
1.............................. 023 Craniotomy with Major
Device Implant or
Acute Complex CNS
Principal Diagnosis
with MCC or
Chemotherapy Implant
or Epilepsy with
Neurostimulator.
1.............................. 024 Craniotomy with Major
Device Implant or
Acute Complex CNS
Principal Diagnosis
without MCC.
1.............................. 025 Craniotomy &
Endovascular
Intracranial
Procedures with MCC.
1.............................. 026 Craniotomy &
Endovascular
Intracranial
Procedures with CC.
1.............................. 027 Craniotomy &
Endovascular
Intracranial
Procedures without CC/
MCC.
1.............................. 040 Peripheral, Cranial
Nerve & Other Nervous
System Procedures with
MCC.
1.............................. 041 Peripheral, Cranial
Nerve & Other Nervous
System Procedures with
CC or Peripheral
Neurostimulator.
1.............................. 042 Peripheral, Cranial
Nerve & Other Nervous
System Procedures
without CC/MCC.
3.............................. 129 Major Head & Neck
Procedures with CC/MCC
or Major Device.
3.............................. 130 Major Head & Neck
Procedures without CC/
MCC.
5.............................. 215 Other Heart Assist
System Implant.
5.............................. 216 Cardiac Valve & Other
Major Cardiothoracic
Procedure with Cardiac
Catheterization with
MCC.
5.............................. 217 Cardiac Valve & Other
Major Cardiothoracic
Procedure with Cardiac
Catheterization with
CC.
5.............................. 218 Cardiac Valve & Other
Major Cardiothoracic
Procedure with Cardiac
Catheterization
without CC/MCC.
5.............................. 219 Cardiac Valve & Other
Major Cardiothoracic
Procedure without
Cardiac
Catheterization with
MCC.
5.............................. 220 Cardiac Valve & Other
Major Cardiothoracic
Procedure without
Cardiac
Catheterization with
CC.
5.............................. 221 Cardiac Valve & Other
Major Cardiothoracic
Procedure without
Cardiac
Catheterization
without CC/MCC.
5.............................. 222 Cardiac Defibrillator
Implant with Cardiac
Catheterization with
AMI/Heart Failure/
Shock with MCC.
[[Page 41249]]
5.............................. 223 Cardiac Defibrillator
Implant with Cardiac
Catheterization with
AMI/Heart Failure/
Shock without MCC.
5.............................. 224 Cardiac Defibrillator
Implant with Cardiac
Catheterization
without AMI/Heart
Failure/Shock with
MCC.
5.............................. 225 Cardiac Defibrillator
Implant with Cardiac
Catheterization
without AMI/Heart
Failure/Shock without
MCC.
5.............................. 226 Cardiac Defibrillator
Implant without
Cardiac
Catheterization with
MCC.
5.............................. 227 Cardiac Defibrillator
Implant without
Cardiac
Catheterization
without MCC.
5.............................. 242 Permanent Cardiac
Pacemaker Implant with
MCC.
5.............................. 243 Permanent Cardiac
Pacemaker Implant with
CC.
5.............................. 244 Permanent Cardiac
Pacemaker Implant
without CC/MCC.
5.............................. 245 AICD Generator
Procedures.
5.............................. 258 Cardiac Pacemaker
Device Replacement
with MCC.
5.............................. 259 Cardiac Pacemaker
Device Replacement
without MCC.
5.............................. 260 Cardiac Pacemaker
Revision Except Device
Replacement with MCC.
5.............................. 261 Cardiac Pacemaker
Revision Except Device
Replacement with CC.
5.............................. 262 Cardiac Pacemaker
Revision Except Device
Replacement without CC/
MCC.
5.............................. 265 AICD Lead Procedures.
5.............................. 266 Endovascular Cardiac
Valve Replacement with
MCC.
5.............................. 267 Endovascular Cardiac
Valve Replacement
without MCC.
5.............................. 268 Aortic and Heart Assist
Procedures Except
Pulsation Balloon with
MCC.
5.............................. 269 Aortic and Heart Assist
Procedures Except
Pulsation Balloon
without MCC.
5.............................. 270 Other Major
Cardiovascular
Procedures with MCC.
5.............................. 271 Other Major
Cardiovascular
Procedures with CC.
5.............................. 272 Other Major
Cardiovascular
Procedures without CC/
MCC.
8.............................. 461 Bilateral or Multiple
Major Joint Procedures
Of Lower Extremity
with MCC.
8.............................. 462 Bilateral or Multiple
Major Joint Procedures
of Lower Extremity
without MCC.
8.............................. 466 Revision of Hip or Knee
Replacement with MCC.
8.............................. 467 Revision of Hip or Knee
Replacement with CC.
8.............................. 468 Revision of Hip or Knee
Replacement without CC/
MCC.
8.............................. 469 Major Hip and Knee
Joint Replacement or
Reattachment of Lower
Extremity with MCC or
Total Ankle
Replacement.
8.............................. 470 Major Hip and Knee
Joint Replacement or
Reattachment of Lower
Extremity without MCC.
------------------------------------------------------------------------
We did not receive any public comments on our proposal to continue
to include the existing MS-DRGs currently subject to the policy and to
not add any additional MS-DRGs. Therefore, we are finalizing the list
of MS-DRGs in the table included in the proposed rule and above that
will be subject to the replaced devices offered without cost or with a
credit policy, effective October 1, 2018.
20. Other Policy Changes: Other Operating Room (O.R.) and Non-O.R.
Issues
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20251 through
20257), we addressed requests that we received regarding changing the
designation of specific ICD-10-PCS procedure codes from non-O.R. to
O.R. procedures, or changing the designation from O.R. procedure to
non-O.R. procedure. In cases where we proposed to change the
designation of procedure codes from non-O.R. to O.R. procedures, we
also proposed one or more MS-DRGs with which these procedures are
clinically aligned and to which the procedure code would be assigned.
We generally examine the MS-DRG assignment for similar procedures, such
as the other approaches for that procedure, to determine the most
appropriate MS-DRG assignment for procedures newly designated as O.R.
procedures. We invited public comments on these proposed MS-DRG
assignments.
We also noted that many MS-DRGs require the presence of any O.R.
procedure. As a result, cases with a principal diagnosis associated
with a particular MS-DRG would, by default, be grouped to that MS-DRG.
Therefore, we do not list these MS-DRGs in our discussion below.
Instead, we only discussed MS-DRGs that require explicitly adding the
relevant procedures codes to the GROUPER logic in order for those
procedure codes to affect the MS-DRG assignment as intended. In
addition, cases that contain O.R. procedures will map to MS-DRGs 981,
982, or 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively) or MS-DRGs 987,
988, or 989 (Non-Extensive O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively) when
they do not contain a principal diagnosis that corresponds to one of
the MDCs to which that procedure is assigned. These procedures need not
be assigned to MS-DRGs 981 through 989 in order for this to occur.
Therefore, if requestors included some or all of MS-DRGs 981 through
989 in their request or included MS-DRGs that require the presence of
any O.R. procedure, we did not specifically address that aspect in
summarizing their request or our response to the request in the section
below.
(a) Percutaneous and Percutaneous Endoscopic Excision of Brain and
Cerebral Ventricle
One requestor identified 22 ICD-10-PCS procedure codes that
describe procedures involving transcranial brain and cerebral ventricle
excision that the requestor stated would generally require the
resources of an operating room. The 22 procedure codes are listed in
the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
00B03ZX................... Excision of brain, percutaneous approach,
diagnostic.
[[Page 41250]]
00B13ZX................... Excision of cerebral meninges, percutaneous
approach, diagnostic.
00B23ZX................... Excision of dura mater, percutaneous
approach, diagnostic.
00B63ZX................... Excision of cerebral ventricle, percutaneous
approach, diagnostic.
00B73ZX................... Excision of cerebral hemisphere,
percutaneous approach, diagnostic.
00B83ZX................... Excision of basal ganglia, percutaneous
approach, diagnostic.
00B93ZX................... Excision of thalamus, percutaneous approach,
diagnostic.
00BA3ZX................... Excision of hypothalamus, percutaneous
approach, diagnostic.
00BB3ZX................... Excision of pons, percutaneous approach,
diagnostic.
00BC3ZX................... Excision of cerebellum, percutaneous
approach, diagnostic.
00BD3ZX................... Excision of medulla oblongata, percutaneous
approach, diagnostic.
00B04ZX................... Excision of brain, percutaneous endoscopic
approach, diagnostic.
00B14ZX................... Excision of cerebral meninges, percutaneous
endoscopic approach, diagnostic.
00B24ZX................... Excision of dura mater, percutaneous
endoscopic approach, diagnostic.
00B64ZX................... Excision of cerebral ventricle, percutaneous
endoscopic approach, diagnostic.
00B74ZX................... Excision of cerebral hemisphere,
percutaneous endoscopic approach,
diagnostic.
00B84ZX................... Excision of basal ganglia, percutaneous
endoscopic approach, diagnostic.
00B94ZX................... Excision of thalamus, percutaneous
endoscopic approach, diagnostic.
00BA4ZX................... Excision of hypothalamus, percutaneous
endoscopic approach, diagnostic.
00BB4ZX................... Excision of pons, percutaneous endoscopic
approach, diagnostic.
00BC4ZX................... Excision of cerebellum, percutaneous
endoscopic approach, diagnostic.
00BD4ZX................... Excision of medulla oblongata, percutaneous
endoscopic approach, diagnostic.
------------------------------------------------------------------------
The requestor stated that, although percutaneous burr hole biopsies
are performed through smaller openings in the skull than open burr hole
biopsies, these procedures require drilling or cutting through the
skull using sterile technique with anesthesia for pain control. The
requestor also noted that similar procedures involving percutaneous
drainage of the subdural space are currently classified as O.R.
procedures in Version 35 of the ICD-10 MS-DRGs. However, these 22 ICD-
10-PCS procedure codes are not recognized as O.R. procedures for
purposes of MS-DRG assignment. The requestor recommended that the 22
ICD-10-PCS codes be designated as O.R. procedures and assigned to MS-
DRGs 25, 26, and 27 (Craniotomy and Endovascular Intracranial
Procedures with MCC, with CC, and without CC/MCC, respectively).
In the proposed rule, we stated that we agreed with the requestor
that these procedures typically require the resources of an operating
room. Therefore, we proposed to add these 22 ICD-10-PCS procedure codes
to the FY 2019 ICD-10 MS-DRGs Version 36 Definitions Manual in Appendix
E--Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures assigned to MS-DRGs 25, 26, and 27 in MDC 1 (Diseases and
Disorders of the Nervous System).
Comment: One commenter supported the proposal to change the
designation of the 22 procedure codes listed in the table above to O.R.
procedures.
Response: We appreciate the commenter's support.
After consideration of the public comment we received, we are
finalizing our proposal to change the designation of the 22 ICD-10-PCS
procedure codes shown in the table above from non-O.R. procedures to
O.R. procedures, effective October 1, 2018.
b. Open Extirpation of Subcutaneous Tissue and Fascia
One requestor identified 22 ICD-10-PCS procedure codes that
describe procedures involving open extirpation of subcutaneous tissue
and fascia that the requestor stated would generally require the
resources of an operating room. The 22 procedure codes are listed in
the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0JC00ZZ................... Extirpation of matter from scalp
subcutaneous tissue and fascia, open
approach.
0JC10ZZ................... Extirpation of matter from face subcutaneous
tissue and fascia, open approach.
0JC40ZZ................... Extirpation of matter from right neck
subcutaneous tissue and fascia, open
approach.
0JC50ZZ................... Extirpation of matter from left neck
subcutaneous tissue and fascia, open
approach.
0JC60ZZ................... Extirpation of matter from chest
subcutaneous tissue and fascia, open
approach.
0JC70ZZ................... Extirpation of matter from back subcutaneous
tissue and fascia, open approach.
0JC80ZZ................... Extirpation of matter from abdomen
subcutaneous tissue and fascia, open
approach.
0JC90ZZ................... Extirpation of matter from buttock
subcutaneous tissue and fascia, open
approach.
0JCB0ZZ................... Extirpation of matter from perineum
subcutaneous tissue and fascia, open
approach.
0JCC0ZZ................... Extirpation of matter from pelvic region
subcutaneous tissue and fascia, open
approach.
0JCD0ZZ................... Extirpation of matter from right upper arm
subcutaneous tissue and fascia, open
approach.
0JCF0ZZ................... Extirpation of matter from left upper arm
subcutaneous tissue and fascia, open
approach.
0JCG0ZZ................... Extirpation of matter from right lower arm
subcutaneous tissue and fascia, open
approach.
0JCH0ZZ................... Extirpation of matter from left lower arm
subcutaneous tissue and fascia, open
approach.
0JCJ0ZZ................... Extirpation of matter from right hand
subcutaneous tissue and fascia, open
approach.
0JCK0ZZ................... Extirpation of matter from left hand
subcutaneous tissue and fascia, open
approach.
0JCL0ZZ................... Extirpation of matter from right upper leg
subcutaneous tissue and fascia, open
approach.
0JCM0ZZ................... Extirpation of matter from left upper leg
subcutaneous tissue and fascia, open
approach.
0JCN0ZZ................... Extirpation of matter from right lower leg
subcutaneous tissue and fascia, open
approach.
0JCP0ZZ................... Extirpation of matter from left lower leg
subcutaneous tissue and fascia, open
approach.
0JCQ0ZZ................... Extirpation of matter from right foot
subcutaneous tissue and fascia, open
approach.
0JCR0ZZ................... Extirpation of matter from left foot
subcutaneous tissue and fascia, open
approach.
------------------------------------------------------------------------
[[Page 41251]]
The requestor stated that these procedures involve making an open
incision deeper than the skin under general anesthesia, and that
irrigation and/or excision of devitalized tissue or cavity are often
required and are considered inherent to the procedure. The requestor
also stated that open drainage of subcutaneous tissue and fascia, open
excisional debridement of subcutaneous tissue and fascia, and open
nonexcisional debridement/extraction of subcutaneous tissue and fascia
are designated as O.R. procedures, and that these 22 procedures should
be designated as O.R. procedures for the same reason. In the ICD-10 MS-
DRGs Version 35, these 22 ICD-10-PCS procedure codes are not recognized
as O.R. procedures for purposes of MS-DRG assignment. The requestor
recommended that the 22 ICD-10-PCS procedure codes listed in the table
be assigned to MS-DRGs 579, 580, and 581 (Other Skin, Subcutaneous
Tissue and Breast Procedures with MCC, CC, and without CC/MCC,
respectively).
In the proposed rule, we stated that we disagreed with the
requestor that these procedures typically require the resources of an
operating room. Our clinical advisors indicated that these open
extirpation procedures are minor procedures that can be performed
outside of an operating room, such as in a radiology suite with CT or
MRI guidance. We disagreed that these procedures are similar to open
drainage procedures. Therefore, we proposed to maintain the status of
these 22 ICD-10-PCS procedure codes as non-O.R. procedures.
Comment: Some commenters supported the proposal to maintain the
designation of the 22 identified procedure codes as non-O.R.
procedures. One commenter opposed the proposal, stating that open
extirpation procedures typically require the use of anesthesia and an
operating room. This commenter stated that the 22 procedures are
similar to open drainage, excisional debridement, and non-excisional
debridement/extraction of subcutaneous tissue and fascia, which are
designated as O.R. procedures.
Response: We appreciate the commenters' support. In response to the
commenter who opposed the proposal, our clinical advisors continue to
believe that these open extirpation procedures are minor procedures
that can be performed outside of an operating room, such as in a
radiology suite with CT or MRI guidance, and therefore do not require
the use of an operating room. Our clinical advisors further noted that
the use of anesthesia frequently occurs in a CT or MRI suite. In
addition, our clinical advisors continue to disagree with the assertion
that these procedures are similar to open drainage procedures because
fewer resources are required for open extirpation procedures relative
to open drainage procedures and the open extirpation procedures are not
usually performed in the operating room.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the non-O.R. status of the 22
identified open extirpation procedures.
c. Open Scrotum and Breast Procedures
One requestor identified 13 ICD-10-PCS procedure codes that
describe procedures involving open drainage, open extirpation, and open
debridement/excision of the scrotum and breast. The requestor stated
that the 13 procedures listed in the following table involve making an
open incision deeper than the skin under general anesthesia, and that
irrigation and/or excision of devitalized tissue or cavity are often
required and are considered inherent to the procedure. The requestor
also stated that open drainage of subcutaneous tissue and fascia, open
excisional debridement of subcutaneous tissue and fascia, open non-
excisional debridement/extraction of subcutaneous tissue and fascia,
and open excision of breast are designated as O.R. procedures, and that
these 13 procedures should be designated as O.R. procedures for the
same reason. In the ICD-10 MS-DRGs Version 35, these 13 ICD-10-PCS
procedure codes are not recognized as O.R. procedures for purposes of
MS-DRG assignment.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0V950ZZ................... Drainage of scrotum, open approach.
0VB50ZZ................... Excision of scrotum, open approach.
0VC50ZZ................... Extirpation of matter from scrotum, open
approach.
0H9U0ZZ................... Drainage of left breast, open approach.
0H9T0ZZ................... Drainage of right breast, open approach.
0H9V0ZZ................... Drainage of bilateral breast, open approach.
0H9W0ZZ................... Drainage of right nipple, open approach.
0H9X0ZZ................... Drainage of left nipple, open approach.
0HCT0ZZ................... Extirpation of matter from right breast,
open approach.
0HCU0ZZ................... Extirpation of matter from left breast, open
approach.
0HCV0ZZ................... Extirpation of matter from bilateral breast,
open approach.
0HCW0ZZ................... Extirpation of matter from right nipple,
open approach.
0HCX0ZZ................... Extirpation of matter from left nipple, open
approach.
------------------------------------------------------------------------
The requestor recommended that the 3 ICD-10-PCS scrotal procedure
codes be assigned to MS-DRGs 717 and 718 (Other Male Reproductive
System O.R. Procedures Except Malignancy with CC/MCC and without CC/
MCC, respectively) and the 10 breast procedure codes be assigned to MS-
DRGs 584 and 585 (Breast Biopsy, Local Excision and Other Breast
Procedures with CC/MCC and without CC/MCC, respectively).
In the proposed rule, we stated that we agreed with the requestor
that these procedures typically require the resources of an operating
room due to the nature of breast and scrotal tissue, as well as with
the MS-DRG assignments recommended by the requestor. In addition, we
stated that we believe that the scrotal codes should also be assigned
to MS-DRGs 715 and 716 (Other Male Reproductive System O.R. Procedures
for Malignancy with CC/MCC and without CC/MCC, respectively).
Therefore, we proposed to add these 13 ICD-10-PCS procedure codes to
the FY 2019 ICD-10 MS-DRGs Version 36 Definitions Manual in Appendix
E--Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures, assigned to MS-DRGs 715, 716, 717, and 718 in MDC 12
(Diseases and Disorders of the Male Reproductive System) for the
scrotal procedure codes and assigned to MS-DRGs 584 and 585 in MDC 9
(Diseases and Disorders of the Skin,
[[Page 41252]]
Subcutaneous Tissue & Breast) for the breast procedure codes.
Comment: Commenters supported the proposal to change the
designation of the 13 identified procedure codes to O.R. procedures.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the 13 ICD-10-PCS
procedure codes shown in the table above from non-O.R. procedures to
O.R. procedures, effective October 1, 2018.
d. Open Parotid Gland and Submaxillary Gland Procedures
One requestor identified eight ICD-10-PCS procedure codes that
describe procedures involving open drainage and open extirpation of the
parotid or submaxillary glands, shown in the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0C980ZZ................... Drainage of right parotid gland, open
approach.
0C990ZZ................... Drainage of left parotid gland, open
approach.
0C9G0ZZ................... Drainage of right submaxillary gland, open
approach.
0C9H0ZZ................... Drainage of left submaxillary gland, open
approach.
0CC80ZZ................... Extirpation of matter from right parotid
gland, open approach.
0CC90ZZ................... Extirpation of matter from left parotid
gland, open approach.
0CCG0ZZ................... Extirpation of matter from right
submaxillary gland, open approach.
0CCH0ZZ................... Extirpation of matter from left submaxillary
gland, open approach.
------------------------------------------------------------------------
The requestor stated that these procedures involve making an open
incision through subcutaneous tissue, fascia, and potentially muscle,
to reach and incise the parotid or submaxillary gland under general
anesthesia, and that irrigation and/or excision of devitalized tissue
or cavity may be required and are considered inherent to the procedure.
The requestor also stated that open drainage of subcutaneous tissue and
fascia, open excisional debridement of subcutaneous tissue and fascia,
and open non-excisional debridement/extraction of subcutaneous tissue
and fascia are designated as O.R. procedures, and that these eight
procedures should be designated as O.R. procedures for the same reason.
In the ICD-10 MS-DRGs Version 35, these eight ICD-10-PCS procedure
codes are not recognized as O.R. procedures for purposes of MS-DRG
assignment. The requestor requested that these procedures be assigned
to MS-DRG 139 (Salivary Gland Procedures).
In the proposed rule, we stated that we agreed with the requestor
that these eight procedures typically require the resources of an
operating room. Therefore, we proposed to add these ICD-10-PCS
procedure codes to the FY 2019 ICD-10 MS-DRGs Version 36 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index as O.R. procedures assigned to MS-DRG 139 in MDC 3 (Diseases
and Disorders of the Ear, Nose, Mouth and Throat).
Comment: One commenter supported the proposal to change the
designation of the 8 identified procedure codes to O.R. procedures.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the 8 ICD-10-PCS
procedure codes shown in the table above from non-O.R. procedures to
O.R. procedures, effective October 1, 2018.
e. Removal and Reinsertion of Spacer; Knee Joint and Hip Joint
One requestor identified four sets of ICD-10-PCS procedure code
combinations (eight ICD-10-PCS codes) that describe procedures
involving open removal and insertion of spacers into the knee or hip
joints, shown in the following table. The requestor stated that these
are invasive procedures involving removal and reinsertion of devices
into major joints and are performed in the operating room under general
anesthesia. In the ICD-10 MS-DRGs Version 35, these four ICD-10-PCS
procedure code combinations are not recognized as O.R. procedures for
purposes of MS-DRG assignment. The requestor recommended that CMS
determine the most appropriate surgical DRGs for these procedures.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0SPC08Z........................ Removal of spacer from right knee
joint, open approach.
0SHC08Z........................ Insertion of spacer into right knee
joint, open approach.
0SPD08Z........................ Removal of spacer from left knee joint,
open approach.
0SHD08Z........................ Insertion of spacer into left knee
joint, open approach.
0SP908Z........................ Removal of spacer from right hip joint,
open approach.
0SH908Z........................ Insertion of spacer into right hip
joint, open approach.
0SPB08Z........................ Removal of spacer from left hip joint,
open approach.
0SHB08Z........................ Insertion of spacer into left hip
joint, open approach.
------------------------------------------------------------------------
In the proposed rule, we stated that we agreed with the requestor
that these procedures typically require the resources of an operating
room. However, our clinical advisors indicated that these codes should
be designated as O.R. procedures even when reported as stand-alone
procedures. Therefore, for the knee procedures, we proposed to add
these four ICD-10-PCS procedure codes to the FY 2019 ICD-10 MS-DRGs
Version 36 Definitions Manual in Appendix E--Operating Room Procedures
and Procedure Code/MS-DRG Index as O.R. procedures assigned to MS-DRGs
485, 486, and 487 (Knee Procedures with Principal Diagnosis of
Infection with MCC, with CC, and without CC/MCC, respectively) or MS-
DRGs 488 and 489 (Knee Procedures without Principal diagnosis of
Infection with CC/MCC and without CC/MCC, respectively), both in MDC 8
(Diseases and Disorders of the Musculoskeletal
[[Page 41253]]
System and Connective Tissue). For the hip procedures, we proposed to
add these four ICD-10-PCS procedure codes to the FY 2019 ICD-10 MS-DRGs
Version 36 Definitions Manual in Appendix E--Operating Room Procedures
and Procedure Code/MS-DRG Index as O.R. procedures assigned to MS-DRGs
480, 481, and 482 (Hip and Femur Procedures Except Major Joint with
MCC, with CC, and without CC/MCC, respectively) in MDC 8 (Diseases and
Disorders of the Musculoskeletal System and Connective Tissue).
Comment: Commenters supported the proposal to change the
designation of the eight identified procedure codes to O.R. procedures.
Several commenters who supported the proposal also requested that CMS
ensure that changing the designation to O.R. procedures not have the
unintended impact of reducing payment for these procedures. These
commenters also requested that CMS clarify that the proposed MS-DRG
assignments only apply when the eight codes are reported as stand-alone
procedures and not, for example, when a spacer is removed and a
permanent joint implant is inserted. One commenter stated that
additional cost data would be useful in determining whether the payment
for the proposed MS-DRGs fully reflect the O.R. resources used in these
procedures.
Response: We appreciate the commenters' support. With regard to the
MS-DRG assignment, we are clarifying that, in all cases, the GROUPER
logic would consider all of the procedures reported, the principal
diagnosis, the surgical hierarchy, and the MS-DRG assignments for those
procedures to determine the appropriate MS-DRG assignment. In cases
where there is a procedure that is used for MS-DRG assignment that is
higher in the surgical hierarchy, that procedure code would determine
the MS-DRG assignment. In cases where the other procedure(s) are lower
in the surgical hierarchy, the case would be assigned to the MS-DRGs
listed above. With regard to the comments about the implications for
payment and the cost data, we note that the goals of changing the
designation of procedures from non-O.R. to O.R., or vice versa, are to
better clinically represent the resources involved in caring for these
patients and to enhance the overall accuracy of the system. Therefore,
decisions to change an O.R. designation are based on whether such a
change would accomplish those goals and not whether the change in
designation would impact the payment in a particular direction.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the eight ICD-10-
PCS procedure codes shown in the table above from non-O.R. procedures
to O.R. procedures, effective October 1, 2018.
f. Endoscopic Dilation of Ureter(s) With Intraluminal Device
One requestor identified the following three ICD-10-PCS procedure
codes that describe procedures involving endoscopic dilation of
ureter(s) with intraluminal device.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0T778DZ................... Dilation of left ureter with intraluminal
device, via natural or artificial opening
endoscopic.
0T768DZ................... Dilation of right ureter with intraluminal
device, via natural or artificial opening
endoscopic.
0T788DZ................... Dilation of bilateral ureters with
intraluminal device, via natural or
artificial opening endoscopic.
------------------------------------------------------------------------
The requestor stated that these procedures involve the use of
cystoureteroscopy to view the bladder and ureter and dilation under
visualization, which are often followed by placement of a ureteral
stent. The requestor also stated that endoscopic extirpation of matter
from ureter, endoscopic biopsy of bladder, endoscopic dilation of
bladder, endoscopic dilation of renal pelvis, and endoscopic dilation
of the ureter without insertion of intraluminal device are all assigned
to surgical DRGs, and that these three procedures should be designated
as O.R. procedures for the same reason. In the ICD-10 MS-DRGs Version
35, these three ICD-10-PCS procedure codes are not recognized as O.R.
procedures for purposes of MS-DRG assignment. The requestor recommended
that these procedures be assigned to MS-DRGs 656, 657, and 658 (Kidney
and Ureter Procedures for Neoplasm with MCC, with CC, and without CC/
MCC, respectively) and MS-DRGs 659, 660, and 661 (Kidney and Ureter
Procedures for Non-Neoplasm with MCC, with CC, and without CC/MCC,
respectively).
In the proposed rule, we stated that we agreed with the requestor
that these procedures typically require the resources of an operating
room. In addition to the MS-DRGs recommended by the requestor, we
further stated that we believe that these procedure codes should also
be assigned to other MS-DRGs, consistent with the assignment of other
dilation of ureter procedures: MS-DRG 907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with CC, and without CC/MCC,
respectively) and MS-DRGs 957, 958, and 959 (Other O.R. Procedures for
Multiple Significant Trauma with MCC, with CC, and without CC/MCC,
respectively). Therefore, we proposed to add the three ICD-10-PCS
procedure codes identified by the requestor to the FY 2019 ICD-10 MS-
DRGs Version 36 Definitions Manual in Appendix E--Operating Room
Procedures and Procedure Code/MS-DRG Index as O.R. procedures assigned
to MS-DRGs 656, 657, and 658 in MDC 11 (Diseases and Disorders of the
Kidney and Urinary Tract), MS-DRGs 659, 660, and 661 in MDC 11, MS-DRGs
907, 908, and 909 in MDC 21 (Injuries, Poisonings and Toxic Effects of
Drugs), and MS-DRGs 957, 958, and 959 in MDC 24 (Multiple Significant
Trauma).
Comment: One commenter supported the proposal to change the
designation of the three identified procedure codes to O.R. procedures.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the three ICD-10-
PCS procedure codes shown in the table above from non-O.R. procedures
to O.R. procedures, effective October 1, 2018.
g. Thoracoscopic Procedures of Pericardium and Pleura
One requestor identified seven ICD-10-PCS procedure codes that
describe procedures involving thoracoscopic drainage of the pericardial
cavity or pleural cavity, or extirpation of matter from the pleura, as
shown in the following table.
[[Page 41254]]
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0W9D4ZZ................... Drainage of pericardial cavity, percutaneous
endoscopic approach.
0W9D40Z................... Drainage of pericardial cavity with drainage
device, percutaneous endoscopic approach.
0W9D4ZX................... Drainage of pericardial cavity, percutaneous
endoscopic approach, diagnostic.
0W994ZX................... Drainage of right pleural cavity,
percutaneous endoscopic approach,
diagnostic.
0W9B4ZX................... Drainage of left pleural cavity,
percutaneous endoscopic approach,
diagnostic.
0BCP4ZZ................... Extirpation of matter from left pleura,
percutaneous endoscopic approach.
0BCN4ZZ................... Extirpation of matter from right pleura,
percutaneous endoscopic approach.
------------------------------------------------------------------------
The requestor stated that these procedures involve making an
incision through the chest wall and inserting a thoracoscope for
visualization of thoracic structures during the procedure. The
requestor also stated that some thoracoscopic procedures are assigned
to surgical MS-DRGs, while other procedures are assigned to medical MS-
DRGs. In the ICD-10 MS-DRGs Version 35, these seven ICD-10-PCS
procedure codes are not recognized as O.R. procedures for purposes of
MS-DRG assignment.
In the proposed rule, we stated that we agreed with the requestor
that these procedures typically require the resources of an operating
room, as well as significant time and skill. During our review, we
noted that the following two related procedures using the open approach
also were not currently recognized as O.R. procedures:
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0BCP0ZZ........................ Extirpation of matter from left pleura,
open approach.
0BCN0ZZ........................ Extirpation of matter from right
pleura, open approach.
------------------------------------------------------------------------
Therefore, to be consistent with the MS-DRGs to which other
approaches for procedures involving drainage or extirpation of matter
from the pleura are assigned, we proposed to add these nine ICD-10-PCS
procedure codes to the FY 2019 ICD-10 MS-DRGs Version 36 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index as O.R. procedures assigned to one of the following MS-DRGs:
MS-DRGs 163, 164, and 165 (Major Chest Procedures with MCC, with CC,
and without CC/MCC, respectively) in MDC 4 (Diseases and Disorders of
the Respiratory System); MS-DRGs 270, 271, and 272 (Other Major
Cardiovascular Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 5 (Diseases and Disorders of the Circulatory
System); MS-DRGs 820, 821, and 822 (Lymphoma and Leukemia with Major
O.R. Procedure with MCC, with CC, and without CC/MCC, respectively) in
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly
Differentiated Neoplasms); MS-DRGs 826, 827, and 828
(Myeloproliferative Disorders or Poorly Differentiated Neoplasms with
Major O.R. Procedure with MCC, with CC, and without CC/MCC,
respectively) in MDC 17; MS-DRGs 907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with CC, and without CC/MCC,
respectively) in MDC 21 (Injuries, Poisonings and Toxic Effects of
Drugs); and MS-DRGs 957, 958, and 959 (Other O.R. Procedures for
Multiple Significant Trauma with MCC, with CC, and without CC/MCC,
respectively) in MDC 24 (Multiple Significant Trauma). We invited
public comments on our proposal.
Comment: One commenter supported the proposal to change the
designation of the nine identified procedure codes to O.R. procedures.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the nine ICD-10-
PCS procedure codes shown in the tables above from non-O.R. procedures
to O.R. procedures, effective October 1, 2018.
h. Open Insertion of Totally Implantable and Tunneled Vascular Access
Devices
One requestor identified 20 ICD-10-PCS procedure codes that
describe procedures involving open insertion of totally implantable and
tunneled vascular access devices. The codes are identified in the
following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0JH60WZ................... Insertion of totally implantable vascular
access device into chest subcutaneous
tissue and fascia, open approach.
0JH60XZ................... Insertion of tunneled vascular access device
into chest subcutaneous tissue and fascia,
open approach.
0JH80WZ................... Insertion of totally implantable vascular
access device into abdomen subcutaneous
tissue and fascia, open approach.
0JH80XZ................... Insertion of tunneled vascular access device
into abdomen subcutaneous tissue and
fascia, open approach.
0JHD0WZ................... Insertion of totally implantable vascular
access device into right upper arm
subcutaneous tissue and fascia, open
approach.
0JHD0XZ................... Insertion of tunneled vascular access device
into right upper arm subcutaneous tissue
and fascia, open approach.
0JHF0WZ................... Insertion of totally implantable vascular
access device into left upper arm
subcutaneous tissue and fascia, open
approach.
0JHF0XZ................... Insertion of tunneled vascular access device
into left upper arm subcutaneous tissue and
fascia, open approach.
0JHG0WZ................... Insertion of totally implantable vascular
access device into right lower arm
subcutaneous tissue and fascia, open
approach.
0JHG0XZ................... Insertion of tunneled vascular access device
into right lower arm subcutaneous tissue
and fascia, open approach.
0JHH0WZ................... Insertion of totally implantable vascular
access device into left lower arm
subcutaneous tissue and fascia, open
approach.
0JHH0XZ................... Insertion of tunneled vascular access device
into left lower arm subcutaneous tissue and
fascia, open approach.
0JHL0WZ................... Insertion of totally implantable vascular
access device into right upper leg
subcutaneous tissue and fascia, open
approach.
0JHL0XZ................... Insertion of tunneled vascular access device
into right upper leg subcutaneous tissue
and fascia, open approach.
0JHM0WZ................... Insertion of totally implantable vascular
access device into left upper leg
subcutaneous tissue and fascia, open
approach.
0JHM0XZ................... Insertion of tunneled vascular access device
into left upper leg subcutaneous tissue and
fascia, open approach.
0JHN0WZ................... Insertion of totally implantable vascular
access device into right lower leg
subcutaneous tissue and fascia, open
approach.
[[Page 41255]]
0JHN0XZ................... Insertion of tunneled vascular access device
into right lower leg subcutaneous tissue
and fascia, open approach.
0JHP0WZ................... Insertion of totally implantable vascular
access device into left lower leg
subcutaneous tissue and fascia, open
approach.
0JHP0XZ................... Insertion of tunneled vascular access device
into left lower leg subcutaneous tissue and
fascia, open approach.
------------------------------------------------------------------------
The requestor stated that open procedures to insert totally
implantable vascular access devices (VAD) involve implantation of a
port by open approach, cutting through subcutaneous tissue/fascia,
placing the device, and then closing tissues so that none of the device
is exposed. The requestor explained that open procedures to insert
tunneled VADs involve insertion of the catheter into central
vasculature, and then open incision of subcutaneous tissue and fascia
through which the device is tunneled. The requestor also indicated that
these procedures require two ICD-10-PCS codes: One for the insertion of
the VAD or port within the subcutaneous tissue; and one for
percutaneous insertion of the central venous catheter that is connected
to the device. The requestor further noted that, in MDC 11, cases with
these procedure codes are assigned to surgical MS-DRGs and that
insertion of infusion pumps by open approach groups to surgical MS-
DRGs. The requestor recommended that these procedures be assigned to
surgical MS-DRGs in MDC 09 as well. We examined the O.R. designations
for this group of procedures and determined that they currently are
designated as non-O.R. procedures for MDC 09 and MDC 11.
In the proposed rule, we stated that we agreed with the requestor
that procedures involving open insertion of totally implantable VAD
procedures typically require the resources of an operating room.
However, we stated that we disagreed that the tunneled VAD procedures
typically require the resources of an operating room. Therefore, we
proposed to update the FY 2019 ICD-10 MS-DRGs Version 36 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index to designate the 10 ICD-10-PCS procedure codes describing the
totally implantable VAD procedures as O.R. procedures, which will
continue to be assigned to MS-DRGs 579, 580, and 581 (Other Skin,
Subcutaneous Tissue and Breast Procedures with MCC, with CC, and
without CC/MCC, respectively) in MDC 9 (Diseases and Disorders of the
Skin, Subcutaneous Tissue and Breast) and MS-DRGs 673, 674, and 675
(Other Kidney and Urinary Tract Procedures, with CC, with MCC, and
without CC/MCC, respectively) in MDC 11 (Diseases and Disorders of the
Kidney and Urinary Tract). We noted that these procedures already
affect MS-DRG assignment to these MS-DRGs. However, we stated that if
the procedure is unrelated to the principal diagnosis, it will be
assigned to MS-DRGs 981, 982, and 983 instead of a medical MS-DRG.
Comment: Commenters supported the proposal to change the
designation of the open insertion of totally implantable VAD procedures
to O.R. procedures. One commenter requested that CMS reconsider the
GROUPER logic to add totally implantable VADs to additional MDCs, and
not just MDCs 9 and 11.
Response: We appreciate the commenters' support. With regard to the
GROUPER logic, we will consider whether procedures should be added to
additional MDCs during our annual assessment of the codes that group to
the unrelated procedure MS-DRGs, which is discussed later in this
section of the preamble of this final rule.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the 10 ICD-10-PCS
procedure codes describing open insertion of totally implantable VAD
procedures shown in the table above from non-O.R. procedures to O.R.
procedures, effective October 1, 2018.
Comment: Some commenters supported the proposal to maintain the
non-O.R. assignment of the tunneled VAD procedures listed in the table
above, while others opposed this proposal. The commenters who opposed
the proposal stated that tunneled VAD procedures involve significantly
more resources than non-tunneled catheters because of the significant
subcutaneous tunneling required. The commenters also noted that the
procedures require the specialized setting of an operating room or
interventional radiology suite. The commenters explained the following
aspects of the technique that they believe indicate that the procedures
should be designated as O.R. procedures: A small incision is typically
made and one end of the catheter is advanced into the internal jugular
vein, and threaded into the superior/inferior vena cava, or right
atrium under fluoroscopic guidance. The other end of the catheter is
tunneled beneath the skin and subcutaneous tissue and a small incision
is made at the exit site on the chest. A small cuff is sometimes
anchored to the skin to stabilize and prevent infection. While the
tunneled VADs are typically performed with small incisions, the
subcutaneous tunneling is the most complex portion of the procedure. In
addition, one commenter listed additional tunneled VAD codes (performed
on other body parts, such as the arms and legs) that should also be
considered for a change to the O.R. designation.
Response: Our clinical advisors continue to believe that tunneled
VAD procedures do not typically require the use of an operating room.
As the commenter stated, these procedures are frequently performed
under image guidance, which our clinical advisors believe would
typically take place in a radiology suite. Our clinical advisors
believe that the list of other VAD procedures cited by the commenter
would also typically take place in the radiology suite and, therefore,
would not typically require the use of an operating room. Therefore, we
are not making a change to the O.R. designation of the codes suggested
by the commenter.
After consideration of the public comments we received, we are
finalizing our proposals to change the designation of the totally
implantable VAD procedures to O.R. procedures and to maintain the non-
O.R. designation of the tunneled VAD procedures.
i. Percutaneous Joint Reposition With Internal Fixation Device
One requestor identified 20 ICD-10-PCS procedure codes that
describe procedures involving percutaneous joint reposition with
internal fixation device, shown in the following table.
[[Page 41256]]
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0SS034Z................... Reposition lumbar vertebral joint with
internal fixation device, percutaneous
approach.
0SS334Z................... Reposition lumbosacral joint with internal
fixation device, percutaneous approach.
0SS534Z................... Reposition sacrococcygeal joint with
internal fixation device, percutaneous
approach.
0SS634Z................... Reposition coccygeal joint with internal
fixation device, percutaneous approach.
0SS734Z................... Reposition right sacroiliac joint with
internal fixation device, percutaneous
approach.
0SS834Z................... Reposition left sacroiliac joint with
internal fixation device, percutaneous
approach.
0SS934Z................... Reposition right hip joint with internal
fixation device, percutaneous approach.
0SSB34Z................... Reposition left hip joint with internal
fixation device, percutaneous approach.
0SSC34Z................... Reposition right knee joint with internal
fixation device, percutaneous approach.
0SSD34Z................... Reposition left knee joint with internal
fixation device, percutaneous approach.
0SSF34Z................... Reposition right ankle joint with internal
fixation device, percutaneous approach.
0SSG34Z................... Reposition left ankle joint with internal
fixation device, percutaneous approach.
0SSH34Z................... Reposition right tarsal joint with internal
fixation device, percutaneous approach.
0SSJ34Z................... Reposition left tarsal joint with internal
fixation device, percutaneous approach.
0SSK34Z................... Reposition right tarsometatarsal joint with
internal fixation device, percutaneous
approach.
0SSL34Z................... Reposition left tarsometatarsal joint with
internal fixation device, percutaneous
approach.
0SSM34Z................... Reposition right metatarsal-phalangeal joint
with internal fixation device, percutaneous
approach.
0SSN34Z................... Reposition left metatarsal-phalangeal joint
with internal fixation device, percutaneous
approach.
0SSP34Z................... Reposition right toe phalangeal joint with
internal fixation device, percutaneous
approach.
0SSQ34Z................... Reposition left toe phalangeal joint with
internal fixation device, percutaneous
approach.
------------------------------------------------------------------------
The requestor stated that reposition of the sacrum, femur, tibia,
fibula, and other fractures of bone with internal fixation device by
percutaneous approach are assigned to surgical DRGs, and that
reposition of sacroiliac, hip, knee, and other joint locations with
internal fixation should therefore also be assigned to surgical DRGs.
In the ICD-10 MS-DRGs Version 35, these 20 ICD-10-PCS procedure codes
are not recognized as O.R. procedures for purposes of MS-DRG
assignment.
In the proposed rule, we stated that we disagreed with the
requestor that these procedures typically require the resources of an
operating room, as these procedures are not as invasive as the bone
reposition procedures referenced by the requestor. Our clinical
advisors advised that these procedures are typically performed in a
radiology suite. Therefore, we proposed to maintain the status of these
20 ICD-10-PCS procedure codes as non-O.R. procedures.
Comment: Some commenters supported the proposal to maintain the
status of the 20 ICD-10-PCS procedure codes that describe procedures
involving percutaneous joint reposition with internal fixation device
listed in the table above, while one commenter opposed our proposal.
The commenter who opposed the proposal stated that these procedures are
often done under image guidance, but that they are typically done in
the operating room because they require anesthesia. The commenter
stated that these procedures involving dislocated joints are even more
resource intensive than fracture treatment involving a single bone,
which are classified as O.R. procedures.
Response: Our clinical advisors continue to believe that the
resources involved in furnishing these procedures are consistent with
non-O.R. procedures, given that they are typically done with imaging
guidance. Our clinical advisors noted that it is not uncommon for
anesthesia to be used in the radiology suite, and that the nature of
the resources used in repositioning displaced joints do not require the
use of an operating room.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the non-O.R. status of the 20 ICD-
10-PCS procedure codes that describe procedures involving percutaneous
joint reposition with internal fixation device listed in the table
above.
j. Endoscopic Destruction of Intestine
One requestor identified four ICD-10-PCS procedure codes that
describe procedures involving endoscopic destruction of the intestine,
as shown in the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0D5A8ZZ................... Destruction of jejunum, via natural or
artificial opening endoscopic.
0D5B8ZZ................... Destruction of ileum, via natural or
artificial opening endoscopic.
0D5C8ZZ................... Destruction of ileocecal valve, via natural
or artificial opening endoscopic.
0D588ZZ................... Destruction of small intestine, via natural
or artificial opening endoscopic.
------------------------------------------------------------------------
The requestor stated that these procedures are rarely performed in
the operating room. In the ICD-10 MS-DRGs Version 35, these four ICD-
10-PCS procedure codes are currently recognized as O.R. procedures for
purposes of MS-DRG assignment.
In the proposed rule, we stated that we agreed with the requestor
that these procedures do not typically require the resources of an
operating room. Therefore, we proposed to remove these four procedure
codes from the FY 2019 ICD-10 MS-DRGs Version 36 Definitions Manual in
Appendix E--Operating Room Procedures and Procedure Code/MS-DRG Index
as O.R. procedures.
Comment: One commenter supported the proposal to change the
designation of the four identified procedure codes to non-O.R.
procedures.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the four ICD-10-
PCS procedure codes shown in the table above from O.R. procedures to
non-O.R. procedures, effective October 1, 2018.
[[Page 41257]]
k. Drainage of Lower Lung Via Natural or Artificial Opening Endoscopic,
Diagnostic
One requestor identified the following ICD-10-PCS procedure codes
that describe procedures involving endoscopic drainage of the lung via
natural or artificial opening for diagnostic purposes.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0B9J8ZX................... Drainage of left lower lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9F8ZX................... Drainage of right lower lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
------------------------------------------------------------------------
The requestor stated that these procedures are rarely performed in
the operating room.
In the proposed rule, we stated that we agreed with the requestor
that these procedures do not require the resources of an operating
room. In addition, while we were reviewing this comment, we identified
three additional related codes:
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0B9D8ZX................... Drainage of right middle lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9C8ZX................... Drainage of right upper lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9G8ZX................... Drainage of left upper lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
------------------------------------------------------------------------
In the ICD-10 MS-DRGs Version 35, these ICD-10-PCS procedure codes
are currently recognized as O.R. procedures for purposes of MS-DRG
assignment.
We proposed to remove ICD-10-PCS procedure codes 0B9J8ZX, 0B9F8ZX,
0B9D8ZX, 0B9C8ZX, and 0B9G8ZX from the FY 2019 ICD-10 MS-DRGs Version
36 Definitions Manual in Appendix E--Operating Room Procedures and
Procedure Code/MS-DRG Index as O.R. procedures.
Comment: One commenter supported the proposal to change the
designation of the five identified procedure codes to non-O.R.
procedures.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of the five ICD-10-
PCS procedure codes shown in the tables above from O.R. procedures to
non-O.R. procedures, effective October 1, 2018.
l. Endobronchial Valve Procedures
One commenter responding to the FY 2019 IPPS/LTCH PPS proposed rule
identified eight ICD-10-PCS procedure codes that describe endobronchial
valve procedures that the commenter believed should be designated as
O.R. procedures. The codes are identified in the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0BH38GZ................... Insertion of endobronchial valve into right
main bronchus, via natural or artificial
opening endoscopic.
0BH48GZ................... Insertion of endobronchial valve into right
upper lobe bronchus, via natural or
artificial opening endoscopic.
0BH58GZ................... Insertion of endobronchial valve into right
middle lobe bronchus, via natural or
artificial opening endoscopic.
0BH68GZ................... Insertion of endobronchial valve into right
lower lobe bronchus, via natural or
artificial opening endoscopic.
0BH78GZ................... Insertion of endobronchial valve into left
main bronchus, via natural or artificial
opening endoscopic.
0BH88GZ................... Insertion of endobronchial valve into left
upper lobe bronchus, via natural or
artificial opening endoscopic.
0BH98GZ................... Insertion of endobronchial valve into
lingula bronchus, via natural or artificial
opening endoscopic.
0BHB8GZ................... Insertion of endobronchial valve into left
lower lobe bronchus, via natural or
artificial opening endoscopic.
------------------------------------------------------------------------
The commenter stated that these procedures are most commonly
performed in the O.R., given the need for better monitoring and support
through the process of identifying and occluding a prolonged air leak
using endobronchial valve technology. The commenter also noted that
other endobronchial valve procedures have an O.R. designation. In the
ICD-10 MS-DRGs Version 35, these eight ICD-10-PCS procedure codes are
not recognized as O.R. procedures for purposes of MS-DRG assignment.
The commenter requested that these eight codes be assigned to MS-DRG
163 (Major Chest Procedures with MCC) due to similar cost and resource
use.
Our clinical advisors disagree with the commenter that the eight
identified procedures typically require the use of an operating room.
Our clinical advisors believe that these procedures would typically be
performed in an endoscopy suite. Therefore, we are not changing the
non-O.R. designation of the eight identified ICD-10-PCS codes listed in
the table above.
21. Out of Scope Public Comments Received
We received public comments regarding a number of MS-DRG and
related issues that were outside the scope of the proposals included in
the FY 2019 IPPS/LTCH PPS proposed rule. These comments were as
follows:
One commenter requested that CMS evaluate the MS-DRG
assignment for Face Transplant procedures and its designation as an
extensive versus nonextensive O.R. procedure.
One commenter requested that a new ICD-10-CM diagnosis
code be created for a Kennedy terminal ulcer.
One commenter requested that CMS examine the MS-DRG
assignment and/or payment of patients who are admitted to the hospital
for initiation or titration of certain antiarrhythmic drugs.
One commenter requested that diagnosis codes in category
O9A.2- and
[[Page 41258]]
O9A.3- for obstetrical patients be considered as a principal diagnosis
for MDC 24 (Multiple Significant Trauma).
One commenter requested that new MS-DRGs be created for
endovascular cardiac valve replacements with and without a cardiac
catheterization.
One commenter recommended that CMS analyze claims data for
cases reporting renal replacement therapy and issue guidance to
facilities on the use of the ICD-10-PCS procedure codes.
One commenter requested specific MS-DRG assignments for
ICD-10-PCS codes that were not yet approved at the time of issuance of
the proposed rule.
One commenter recommended changes to the severity level
designation for diagnosis codes that appear in Table 6E.--Revised
Diagnosis Code Titles associated with the proposed rule.
Because we consider these public comments to be outside the scope
of the proposed rule, we are not addressing them in this final rule. As
stated in section II.F.1.b. of the preamble of this final rule, we
encourage individuals with comments about MS-DRG classification to
submit these comments no later than November 1 of each year so that
they can be considered for possible inclusion in the annual proposed
rule and, if included, may be subjected to public review and comment.
We will consider these public comments for possible proposals in future
rulemaking as part of our annual review process.
G. Recalibration of the FY 2019 MS-DRG Relative Weights
1. Data Sources for Developing the Relative Weights
In developing the FY 2019 system of weights, we proposed to use 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 2017 MedPAR data used in this final rule include
discharges occurring on October 1, 2016, through September 30, 2017,
based on bills received by CMS through March 31, 2018, 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
2017 MedPAR file used in calculating the relative weights includes data
for approximately 9,689,743 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 March 31, 2018 update of the FY 2017 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 relative weights for FY 2019 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 FY 2019
relative weights are based on the ICD-10-CM diagnoses and ICD-10-PCS
procedure codes from the FY 2017 MedPAR claims data, grouped through
the ICD-10 version of the FY 2019 GROUPER (Version 36).
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 March 31,
2018 update of the FY 2016 HCRIS for calculating the final FY 2019
cost-based relative weights.
2. Methodology for Calculation of the Relative Weights
As we explain in section II.E.2. of the preamble of this final
rule, we calculated the FY 2019 relative weights based on 19 CCRs, as
we did for FY 2018. The methodology we used to calculate the FY 2019
MS-DRG cost-based relative weights based on claims data in the FY 2017
MedPAR file and data from the FY 2016 Medicare cost reports is as
follows:
To the extent possible, all the claims were regrouped
using the FY 2019 MS-DRG classifications discussed in sections II.B.
and II.F. of the preamble of this final 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 2017 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 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 $30.00 from the sum of
the routine day charges, intensive care charges, pharmacy charges,
implantable devices charges, supplies and 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 and blood products charges, anesthesia charges, cardiac
catheterization charges, CT scan charges, and MRI charges were also
deleted.
At least 92.5 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.
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.
[[Page 41259]]
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 (77 FR 53341 through 53343).
Specifically, because acute care hospitals participating in the BPCI
Initiative still receive IPPS payments under section 1886(d) of the
Act, we include all applicable data from these subsection (d) hospitals
in our IPPS payment modeling and ratesetting calculations as if the
hospitals were not participating in those models under the BPCI
Initiative. 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.
The participation of hospitals in the BPCI initiative is set to
conclude on September 30, 2018. The participation of hospitals in the
Bundled Payments for Care Improvement (BPCI) Advanced model is set to
start on October 1, 2018. The BPCI Advanced model, tested under the
authority of section 3021 of the Affordable Care Act (codified at
section 1115A of the Act), is comprised of a single payment and risk
track, which bundles payments for multiple services beneficiaries
receive during a Clinical Episode. Acute care hospitals may participate
in BPCI Advanced in one of two capacities: As a model Participant or as
a downstream Episode Initiator. Regardless of the capacity in which
they participate in the BPCI Advanced model, participating acute care
hospitals will continue to receive IPPS payments under section 1886(d)
of the Act. Acute care hospitals that are Participants also assume
financial and quality performance accountability for Clinical Episodes
in the form of a reconciliation payment. For additional information on
the BPCI Advanced model, we refer readers to the BPCI Advanced web page
on the CMS Center for Medicare and Medicaid Innovation's website at:
https://innovation.cms.gov/initiatives/bpci-advanced/. As we stated in
the proposed rule, for FY 2019, consistent with how we have treated
hospitals that participated in the BPCI Initiative, we believe it is
appropriate to include all applicable data from the subsection (d)
hospitals participating in the BPCI Advanced model in our IPPS payment
modeling and ratesetting calculations because, as noted above and in
the proposed rule, these hospitals are still receiving IPPS payments
under section 1886(d) of the Act.
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. Statistical outliers were then removed. These charges were then
adjusted to cost by applying the national average CCRs developed from
the FY 2016 cost report data.
The 19 cost centers that we used in the 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. In the FY 2019 IPPS/LTCH PPS proposed
rule (83 FR 20259), we stated that if stakeholders have comments about
the groupings in this table, we may consider those comments as we
finalize our policy. However, we did not receive any comments on the
groupings in this table, and therefore, we are finalizing the groupings
as proposed.
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BILLING CODE 4120-01-C
In the FY 2019 IPPS/LTCH PPS proposed rule, we also invited public
comments on our proposals related to recalibration of the proposed FY
2019 relative weights and the changes in the relative weights from FY
2018.
Comment: Several commenters expressed concern about significant
reductions in the relative weights for certain MS-DRGs, typically
citing reductions of greater than 20 percent from FY 2018. Some
commenters specifically addressed the significant reductions to MS-DRG
215. Commenters stated that the proposed payment rate for MS-DRG 215 is
less than the cost of the medical devices used in these procedures, and
suggested that the reduced payments resulting from the reduction in the
relative weight could limit access to the procedures that map to this
MS-DRG. Some commenters suggested that CMS maintain the relative weight
for MS-DRG 215 at the FY 2018 level until the claims data reflects the
changes in coding advice for
[[Page 41273]]
procedures that map to this MS-DRG. Other commenters suggested a 1-year
policy for FY 2019 to ensure that the 2-year decrease in payment rates
for any MS-DRG from FY 2017 does not exceed 20 percent. Yet other
commenters suggested a phase-in for MS-DRGs with significant reductions
to their weights to give hospitals time to modify their operations to
adapt to the new rates. Commenters referenced prior rulemaking in which
CMS delayed or transitioned changes impacting payment rates to limit
the impact on providers.
Response: As we indicated in the FY 2018 IPPS/LTCH final rule (82
FR 38103), we do not believe it is normally appropriate to address
relative weight fluctuations that appear to be driven by changes in the
underlying data. Nevertheless, after reviewing the comments received
and the data used in our ratesetting calculations, we acknowledge an
outlier circumstance where the weight for an MS-DRG is seeing a
significant reduction of at least 20 percent for each of the 2 years
since CMS began using the ICD-10 data in calculating the relative
weights. While we would ordinarily consider this weight change to be
appropriately driven by the underlying data, given the comments
received and the potential for these declines to be related to the
ongoing implementation of ICD-10, we are adopting a temporary one-time
measure for FY 2019 for an MS-DRG where the FY 2018 relative weight
declined by 20 percent from the FY 2017 relative weight and the FY 2019
relative weight would have declined by 20 percent or more from the FY
2018 relative weight. (We note that no FY 2018 weight declined by more
than 20 percent from FY 2017 due to our FY 2018 policy.) Specifically,
for an MS-DRG meeting this criterion, the FY 2019 relative weight will
be set equal to the FY 2018 final relative weight. We believe this
policy is consistent with our general authority to assign and update
appropriate weighting factors under sections 1886(d)(4)(B) and (C) of
the Act. We also believe that it appropriately addresses the situation
in which the reduction to the FY 2019 relative weights may still be
potentially related to the implementation of ICD-10. We continue to
believe that changes in relative weights that are not of this outlier
magnitude over the 2 years since we first incorporated the ICD-10 data
in our ratesetting are appropriately being driven by the underlying
data and not the implementation of ICD-10. There is a significant
approximately 10-percentage point outlier gap between this type of
reduction and any other reduction that has occurred over the 2-year
period.
3. Development of National Average CCRs
We developed the national average CCRs as follows:
Using the FY 2016 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.
Comment: Several commenters noted that the CCRs used in the
calculation of the relative weights did not match those calculated
using the FY 2016 HCRIS.
Response: We appreciate the commenters bringing this issue to our
attention. The commenters are correct that there was an error in the
calculation of the national average CCRs in the FY 2019 proposed rule,
in that we inadvertently used the FY 2015 HCRIS data rather than the FY
2016 HCRIS data. The CCRs used in the calculation of the relative
weights in this final rule correctly reflect the described methodology
and the FY 2016 HCRIS data.
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. We
calculated the transfer-adjusted discharges for use in the calculation
of the Version 36 MS-DRG relative weights using the statutory expansion
of the postacute care transfer policy to include discharges to hospice
care by a hospice program discussed in section IV.A.2.b. of the
preamble of this final rule. For the purposes of calculating the
normalization factor, we used the transfer-adjusted discharges with the
expanded postacute care transfer policy for Version 35 as well. (When
we calculate the normalization factor, we calculate the transfer-
adjusted case count for the prior GROUPER version (in this case Version
35) and multiply by the weights of that GROUPER. We then compare that
pool to the transfer-adjusted case count using the new GROUPER
version.) The average cost for each MS-DRG was then divided by the
national average standardized cost per case to determine the relative
weight.
The FY 2019 cost-based relative weights were then normalized by an
adjustment factor of 1.761194774 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 19 national average CCRs for FY 2019 are as follows:
------------------------------------------------------------------------
Group CCR
------------------------------------------------------------------------
Routine Days................................................... 0.442
Intensive Days................................................. 0.368
Drugs.......................................................... 0.191
Supplies & Equipment........................................... 0.299
Implantable Devices............................................ 0.309
Therapy Services............................................... 0.304
Laboratory..................................................... 0.113
Operating Room................................................. 0.179
Cardiology..................................................... 0.103
Cardiac Catheterization........................................ 0.11
Radiology...................................................... 0.145
MRIs........................................................... 0.074
CT Scans....................................................... 0.035
Emergency Room................................................. 0.159
Blood and Blood Products....................................... 0.296
Other Services................................................. 0.345
Labor & Delivery............................................... 0.382
Inhalation Therapy............................................. 0.156
Anesthesia..................................................... 0.078
------------------------------------------------------------------------
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
[[Page 41274]]
threshold of 10 cases as the minimum number of cases required to
compute a reasonable weight. We proposed to use that same case
threshold in recalibrating the MS-DRG relative weights for FY 2019.
Using data from the FY 2017 MedPAR file, there were 7 MS-DRGs that
contain fewer than 10 cases. For FY 2019, because we do not have
sufficient MedPAR data to set accurate and stable cost relative weights
for these low-volume MS-DRGs, we proposed to compute relative weights
for the low-volume MS-DRGs by adjusting their final FY 2018 relative
weights by the percentage change in the average weight of the cases in
other MS-DRGs. The crosswalk table is shown:
------------------------------------------------------------------------
Low-volume MS-DRG MS-DRG title Crosswalk to MS-DRG
------------------------------------------------------------------------
789...................... Neonates, Died or Final FY 2018 relative
Transferred to weight (adjusted by
Another Acute Care percent change in
Facility. average weight of the
cases in other MS-
DRGs).
790...................... Extreme Immaturity Final FY 2018 relative
or Respiratory weight (adjusted by
Distress Syndrome, percent change in
Neonate. average weight of the
cases in other MS-
DRGs).
791...................... Prematurity with Final FY 2018 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
792...................... Prematurity without Final FY 2018 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
793...................... Full-Term Neonate Final FY 2018 relative
with Major weight (adjusted by
Problems. percent change in
average weight of the
cases in other MS-
DRGs).
794...................... Neonate with Other Final FY 2018 relative
Significant weight (adjusted by
Problems. percent change in
average weight of the
cases in other MS
DRGs).
795...................... Normal Newborn..... Final FY 2018 relative
weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
------------------------------------------------------------------------
After consideration of the comments we received, we are finalizing
our proposals, with the modification for recalibrating the relative
weights for FY 2019 at the same level as the FY 2018 relative weights
for MS-DRGs where the FY 2018 relative weight declined by 20 percent
from the FY 2017 relative weight and the FY 2019 relative weight would
have declined by 20 percent or more from the FY 2018 relative weight.
H. Add-On Payments for New Services and Technologies for FY 2019
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 or clearance, 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 or cleared by FDA and has been on the market for more than
2 to 3 years. 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).
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 discharges involving the new medical service or technology must be
assessed for adequacy. Under the cost criterion, consistent with the
formula specified in section 1886(d)(5)(K)(ii)(I) of the Act, 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 2018 IPPS/LTCH PPS final rule
contains the final thresholds that we used to evaluate applications for
new medical service or technology add-
[[Page 41275]]
on payments for FY 2019. We refer readers to the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Tables.html to download and view Table 10.
As previously stated, Table 10 that is released with each proposed
and final rule contains the thresholds that we use to evaluate
applications for new medical service and technology add-on payments for
the fiscal year that follows the fiscal year that is otherwise the
subject of the rulemaking. For example, the thresholds in Table 10
released with the FY 2018 IPPS/LTCH PPS final rule are applicable to FY
2019 new technology applications. In the FY 2019 IPPS/LTCH PPS proposed
rule (83 FR 20276), we proposed, beginning with the thresholds for FY
2020 and future years, to provide the thresholds that we previously
included in Table 10 as one of our data files posted via the internet
on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html, which is the same URL
where the impact data files associated with the rulemaking for the
applicable fiscal year are posted. We stated that we believed this
proposed change in the presentation of this information, specifically
in the data files rather than in a Table 10, will clarify for the
public that the listed thresholds will be used for new technology add-
on payment applications for the next fiscal year (in this case, for FY
2020) rather than for the fiscal year that is otherwise the subject of
the rulemaking (in this case, for FY 2019), while continuing to furnish
the same information on the new technology add-on payment thresholds
for applications for the next fiscal year as has been provided in
previous fiscal years. Accordingly, we would no longer include Table 10
as one of our IPPS tables, but would instead include the thresholds
applicable to the next fiscal year (beginning with FY 2020) in the data
files associated with the prior fiscal year (in this case, FY 2019).
We did not receive any public comments on this proposal. Therefore,
we are finalizing the proposal, without modification, and presenting
the MS-DRG threshold amounts (previously included in Table 10 of the
annual IPPS/LTCH PPS proposed and final rules) that will be used in
evaluating new technology add-on payment applications for FY 2020 in a
data file that is available, along with the other data files associated
with this FY 2019 IPPS/LTCH PPS final rule, on the CMS website at:
http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
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 medical
service or 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 or medical
service (if the estimated costs for the case including the new
technology or medical service 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 or medical service.
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 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 the 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 and medical services
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 Medicare Administrative
Contractors (MACs) (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
[[Page 41276]]
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 website, in a user
friendly format. This guide was published in 2010 and is available on
the CMS website at: https://www.cms.gov/Medicare/Coverage/CouncilonTechInnov/Downloads/Innovators-Guide-Master-7-23-15.pdf.
As we indicated in the FY 2009 IPPS final rule (73 FR 48554), we
invite any product developers or manufacturers of new medical services
or 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.
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].
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20277), we noted
that applicants for add-on payments for new medical services or
technologies for FY 2020 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 website at: https://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 2020,
the CMS website also will post the tracking forms completed by each
applicant. We note that the burden associated with this information
collection requirement is the time and effort required to collect and
submit the data in the formal request for add-on payments for new
medical services and technologies to CMS. The aforementioned burden is
subject to the PRA; it is currently approved under OMB control number
0938-1347, which expires on December 31, 2020.
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 2019 prior
to publication of the FY 2019 IPPS/LTCH PPS proposed rule, we published
a notice in the Federal Register on December 4, 2017 (82 FR 57275), and
held a town hall meeting at the CMS Headquarters Office in Baltimore,
MD, on February 13, 2018. In the announcement notice for the meeting,
we stated that the opinions and presentations 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 2019 new medical service and technology add-on payment
applications before the publication of the FY 2019 IPPS/LTCH PPS
proposed rule.
As stated in the proposed rule, approximately 150 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=9niqfxXe4oA&t=217s. 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 February 23, 2018, in our evaluation of the
new technology add-on payment applications for FY 2019 in the FY 2019
IPPS/LTCH PPS proposed rule.
In response to the published notice and the February 13, 2018 New
Technology Town Hall meeting, we received written comments regarding
the applications for FY 2019 new technology add-on payments. (We refer
readers to the FY 2019 IPPS/LTCH PPS proposed rule for summaries of the
comments received in response to the published notice and the New
Technology Town Hall meeting and our responses (83 FR 20278 through
20280).) We also noted in the proposed rule that we do not summarize
comments that are unrelated to the ``substantial clinical improvement''
criterion. As explained earlier and in the Federal Register notice
announcing the New Technology Town Hall meeting (82 FR 57275 through
57277), 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 2019. Therefore, we did
not summarize those written comments in the proposed rule. In section
II.H.5. of the preamble of the FY 2019 IPPS/LTCH PPS proposed rule, we
summarized comments regarding individual applications, or, if
applicable, indicated that there were no comments received in response
to the New Technology Town Hall meeting
[[Page 41277]]
notice, at the end of each discussion of the individual applications.
Public commenters stated opinions and made suggestions relating to
the mapping of new technologies to the appropriate MS-DRG, deeming a
new technology a substantial clinical improvement if it receives HDE
approval from the FDA, and the use of external data in determining the
cost threshold that CMS considers to be outside of the scope of the
proposed rule. Because we did not request public comments nor propose
to make any changes to any of the issues above, we are not summarizing
these public comments, nor responding to them in this final rule. As
noted below in section II.H.5.a. of the preamble of this final rule, we
refer readers to section II.F.2.d. of the preamble of this final rule
for a summary of and our responses to the public comments we received
in response to our solicitation regarding the most appropriate
mechanism to provide payment to hospitals for new technologies, such as
CAR T-cell therapy drugs, including through the use of new technology
add-on payments (82 FR 20294), as well as a summary of the public
comments we received in response to the solicitation for public comment
on our concerns with the payment alternatives that we considered for
CAR T-cell therapy drugs and therapies and our responses to those
comments (83 FR 20190).
3. ICD-10-PCS Section ``X'' Codes for Certain New Medical Services and
Technologies
As discussed in the FY 2016 IPPS/LTCH final rule (80 FR 49434), the
ICD-10-PCS includes a new section containing the new Section ``X''
codes, which began being used with discharges occurring on or after
October 1, 2015. 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. We posted ICD-10-PCS Guidelines on the CMS
website at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html, including guidelines for ICD-10-PCS Section ``X'' codes.
We encourage providers to view the material provided on ICD-10-PCS
Section ``X'' codes.
4. FY 2019 Status of Technologies Approved for FY 2018 Add-On Payments
a. Defitelio[supreg] (Defibrotide)
Jazz Pharmaceuticals submitted an application for new technology
add-on payments for FY 2017 for Defitelio[supreg] (defibrotide), a
treatment for patients diagnosed with hepatic veno-occlusive disease
(VOD) with evidence of multiorgan dysfunction. VOD, also known as
sinusoidal obstruction syndrome (SOS), is a potentially life-
threatening complication of hematopoietic stem cell transplantation
(HSCT), with an incidence rate of 8 percent to 15 percent. Diagnoses of
VOD range in severity from what has been classically defined as a
disease limited to the liver (mild) and reversible, to a severe
syndrome associated with multi-organ dysfunction or failure and death.
Patients treated with HSCT who develop VOD with multi-organ failure
face an immediate risk of death, with a mortality rate of more than 80
percent when only supportive care is used. The applicant asserted that
Defitelio[supreg] improves the survival rate of patients diagnosed with
VOD with multi-organ failure by 23 percent.
Defitelio[supreg] received Orphan Drug Designation for the
treatment of VOD in 2003 and for the prevention of VOD in 2007. It has
been available to patients as an investigational drug through an
expanded access program since 2006. The applicant's New Drug
Application (NDA) for Defitelio[supreg] received FDA approval on March
30, 2016. The applicant confirmed that Defitelio[supreg] was not
available on the U.S. market as of the FDA NDA approval date of March
30, 2016. According to the applicant, commercial packaging could not be
completed until the label for Defitelio[supreg] was finalized with FDA
approval, and that commercial shipments of Defitelio[supreg] to
hospitals and treatment centers began on April 4, 2016. Therefore, we
agreed that, based on this information, the newness period for
Defitelio[supreg] begins on April 4, 2016, the date of its first
commercial availability.
The applicant received approval to use unique ICD-10-PCS procedure
codes to describe the use of Defitelio[supreg], with an effective date
of October 1, 2016. The approved ICD-10PCS procedure codes are: XW03392
(Introduction of defibrotide sodium anticoagulant into peripheral vein,
percutaneous approach); and XW04392 (Introduction of defibrotide sodium
anticoagulant into central vein, percutaneous approach).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
Defitelio[supreg] and consideration of the public comments we received
in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved
Defitelio[supreg] for new technology add-on payments for FY 2017 (81 FR
56906). With the new technology add-on payment application, the
applicant estimated that the average Medicare beneficiary would require
a dosage of 25 mg/kg/day for a minimum of 21 days of treatment. The
recommended dose is 6.25 mg/kg given as a 2-hour intravenous infusion
every 6 hours. Dosing should be based on a patient's baseline body
weight, which is assumed to be 70 kg for an average adult patient. All
vials contain 200 mg at a cost of $825 per vial. Therefore, we
determined that cases involving the use of the Defitelio[supreg]
technology would incur an average cost per case of $151,800 (70 kg
adult x 25 mg/kg/day x 21 days = 36,750 mg per patient/200 mg vial =
184 vials per patient x $825 per vial = $151,800). Under Sec.
412.88(a)(2), we limit new technology add-on payments 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 amount for a case involving the
use of Defitelio[supreg] is $75,900.
Our policy is that a medical service or technology may continue to
be considered ``new'' for purposes of new technology add-on payments
within 2 or 3 years after the point at which data begin to become
available reflecting the inpatient hospital code assigned to the new
service or technology. 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 new technology add-on payments for an additional
year only if the 3-year anniversary date of the product's entry onto
the U.S. market occurs in the latter half of the fiscal year (70 FR
47362).
With regard to the newness criterion for Defitelio[supreg], we
considered the beginning of the newness period to commence on the first
day Defitelio[supreg] was commercially available (April 4, 2016).
Because the 3-year anniversary date of the entry of the
Defitelio[supreg] onto the U.S. market (April 4, 2019) will
[[Page 41278]]
occur in the latter half of FY 2019, in the FY 2019 IPPS/LTCH PPS
proposed rule (83 FR 20280 through 20281), we proposed to continue new
technology add-on payments for this technology for FY 2019. We proposed
that the maximum payment for a case involving Defitelio[supreg] would
remain at $75,900 for FY 2019. We invited public comments on our
proposal to continue new technology add-on payments for
Defitelio[supreg] for FY 2019.
Comment: A few commenters agreed with CMS' proposal to continue new
technology add-on payments for Defitelio[supreg] for FY 2019. In
addition, the applicant provided updated cost information that
indicated, as of April 4, 2018, the current Wholesale Acquisition Cost
(WAC) for Defitelio[supreg] is $875.24 per vial, which changes the
average cost per case from $151,800 to $161,000 (70 kg adult x 25 mg/
kg/day x 21 days = 36,750 mg per patient/200 mg vial = 184 vials per
patient x $875 per vial = $161,000). As such, the applicant requested
that CMS revise the maximum new technology add-on payment for
Defitelio[supreg] for FY 2019 to $80,500, or increase the maximum new
technology add-on payment for cases involving the use of
Defitelio[supreg] to 50 percent of the revised WAC of the technology
per case.
Response: We appreciate the commenters' support and the updated
cost information submitted by the applicant.
After consideration of the public comments we received, we are
finalizing our proposal, with modification, to continue new technology
add-on payments for Defitelio[supreg] for FY 2019. Based on the
applicant's updated cost information, the maximum new technology add-on
payment for a case involving the use of Defitelio[supreg] is $80,500
for FY 2019.
b. EDWARDS INTUITY Elite\TM\ Valve System (INTUITY) and LivaNova
Perceval Valve (Perceval)
Two manufacturers, Edwards Lifesciences and LivaNova, submitted
applications for new technology add-on payments for FY 2018 for the
INTUITY Elite\TM\ Valve System (INTUITY) and the Perceval Valve
(Perceval), respectively. Both of these technologies are prosthetic
aortic valves inserted using surgical aortic valve replacement (AVR).
The applicant for the INTUITY valve stated that it has a unique design,
which utilizes features that were not previously included in
conventional aortic valves. The deployment mechanism allows for rapid
deployment. The expandable frame can reshape the native valve's
orifice, creating a larger and more efficiently shaped effective
orifice area. In addition, the expandable skirt allows for structural
differentiation upon fixation of the valve requiring 3 permanent,
guiding sutures rather than the 12 to 18 permanent sutures used to
fasten standard prosthetic aortic valves. The applicant for the
Perceval valve described the Perceval valve as including: (a) No
permanent sutures; (b) a dedicated delivery system that increases the
surgeon's visibility; (c) an enabler of a minimally invasive approach;
(d) a capability to promote complexity reduction and reproducibility of
the procedure; and (e) a unique device assembly and delivery system.
Aortic valvular disease is relatively common, primarily manifested
by aortic stenosis. Most aortic stenosis is due to calcification of the
valve, either on a normal tri-leaflet valve or on a congenitally
bicuspid valve. The resistance to outflow of blood is progressive over
time, and as the size of the aortic orifice narrows, the heart must
generate increasingly elevated pressures to maintain blood flow.
Symptoms such as angina, heart failure, and syncope eventually develop,
and portend a very serious prognosis. There is no effective medical
therapy for aortic stenosis, so the diseased valve must be replaced or,
less commonly, repaired.
According to both applicants, the INTUITY valve and the Perceval
valve are the first sutureless, rapid deployment aortic valves that can
be used for the treatment of patients who are candidates for surgical
AVR. Because potential cases representing patients who are eligible for
treatment using the INTUITY and the Perceval aortic valve devices would
group to the same MS-DRGs, and we believe that these devices 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 determined
these two devices are substantially similar to each other and that it
was appropriate to evaluate both technologies as one application for
new technology add-on payments under the IPPS.
With respect to the newness criterion, the INTUITY valve received
FDA approval on August 12, 2016, and was commercially available on the
U.S. market on August 19, 2016. The Perceval valve received FDA
approval on January 8, 2016, and was commercially available on the U.S.
market on February 29, 2016. In accordance with our policy, we stated
in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38120) that we believe
it is appropriate to use the earliest market availability date
submitted as the beginning of the newness period. Accordingly, for both
devices, we stated that the beginning of the newness period is February
29, 2016, when the Perceval valve became commercially available. The
ICD-10-PCS code approved to identify procedures involving the use of
both devices when surgically implanted is ICD-10-PCS code X2RF032
(Replacement of aortic valve using zooplastic tissue, rapid deployment
technique, open approach, new technology group 2).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for the INTUITY
and Perceval valves and consideration of the public comments we
received in response to the FY 2018 IPPS/LTCH PPS proposed rule, we
approved the INTUITY and Perceval valves for new technology add-on
payments for FY 2018 (82 FR 38125). We stated that we believed that the
use of a weighted-average of the cost of the standard valves based on
the projected number of cases involving each technology to determine
the maximum new technology add-on payment was most appropriate. To
compute the weighted-cost average, we summed the total number of
projected cases for each of the applicants, which equaled 2,429 cases
(1,750 plus 679). We then divided the number of projected cases for
each of the applicants by the total number of cases, which resulted in
the following case-weighted percentages: 72 percent for the INTUITY and
28 percent for the Perceval valve. We then multiplied the cost per case
for the manufacturer specific valve by the case-weighted percentage
(0.72 * $12,500 = $9,005.76 for INTUITY and 0.28 * $11,500 = $3,214.70
for the Perceval valve). This resulted in a case-weighted average cost
of $12,220.46 for the valves. Under Sec. 412.88(a)(2), we limit new
technology add-on payments 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 INTUITY or Perceval valves is
$6,110.23 for FY 2018.
With regard to the newness criterion for the INTUITY and Perceval
valves, we considered the newness period for the INTUITY and Perceval
valves to begin February 29, 2016. As discussed previously in this
section, in general, we extend new technology add-on payments for an
additional year only if the 3-year anniversary date of the product's
entry onto the U.S. market
[[Page 41279]]
occurs in the latter half of the upcoming fiscal year. Because the 3-
year anniversary date of the entry of the technology onto the U.S.
market (February 29, 2019) will occur in the first half of FY 2019, in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20281), we proposed to
discontinue new technology add-on payments for the INTUITY and Perceval
valves for FY 2019. We invited public comments on our proposal to
discontinue new technology add-on payments for the INTUITY and Perceval
valves.
Comment: Some commenters supported CMS' proposal to discontinue new
technology add-on payments for the INTUITY and Perceval valves and
stated that the consideration of these two applications together
demonstrated CMS' commitment to efficiency and optimization of the new
technology add-on payment application process. Most commenters agreed
that it is appropriate for the newness period to be based on the
earliest anniversary date of the product's entry onto the U.S. market,
given that the two technologies were evaluated and approved as one
application. Other commenters disagreed with CMS' proposal to
discontinue new technology add-on payments for the INTUITY and Perceval
valves for reasons including the following: (1) There is no precedent
for CMS to determine the 3-year anniversary date of a product's entry
onto the U.S. market for two technologies that have been jointly
awarded new technology add-on payments with different market
availability dates; (2) it is inappropriate to choose the earliest
market availability date for this class of technologies because it does
not acknowledge the disparate newness periods for the two applicants;
and (3) Medicare claims data and MS-DRG payment rates do not adequately
reflect the additional costs of these technologies. Instead, some of
these commenters suggested that the mid-point of the two commercial
market availability dates for the Perceval and INTUITY valves be used
as the beginning of the newness period, which would be May 25, 2016.
These commenters believed that, by using the May 25, 2016 mid-point
commercial market availability date, the newness period would conclude
on May 25, 2019, which occurs in the second half of the fiscal year
and, therefore, would allow new technology add-on payments for the
Perceval and INTUITY valves to continue through FY 2019. Another
commenter also disagreed with CMS' proposal to discontinue new
technology add-on payments for the Perceval and INTUITY valves because
the commenter believed that the commercial market availability date of
February 29, 2016, is an inappropriate beginning for the newness period
for the Perceval valve due to the thorough training and education
process that was implemented by LivaNova, which impacted the market
availability of the Perceval valve prior to April 1, 2016, and noted
there were fewer than 30 Medicare patients who received implants
involving the use of the Perceval valve prior to April 1, 2016.
Response: We appreciate the commenters' input. With regard to the
beginning of the technology's newness period, as discussed in the FY
2005 IPPS final rule (69 FR 49003), the timeframe that a new technology
can be eligible to receive new technology add-on payments begins when
data begin to become available. Therefore, the precedent the commenter
mentions regarding two technologies that have been jointly awarded new
technology add-on payments with different commercial market
availability dates is not relevant. 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 inpatient hospital 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).
Section 412.87(b)(2) also specifies that 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 the section.
Additionally, as stated above, we have determined that the Perceval and
INTUITY valves are substantially similar to each other and, therefore,
we used the earliest date when data became available for the technology
to determine the beginning of the newness period. Therefore, the
newness period began February 29, 2016.
In addition, we do not believe that case volume is a relevant
consideration for making the determination as to whether a product is
``new.'' Consistent with the statute and our implementing regulations,
a technology is no longer considered as ``new'' once it is more than 2
to 3 years old, irrespective of how frequently the medical service or
technology has been used in the Medicare population (70 FR 47349). As
such, in this case, because the Perceval and INTUITY valves have been
available on the U.S. market for more than 2 to 3 years, we consider
the costs to have been included in the MS-DRG relative weights
regardless of whether the technologies' use in the Medicare population
has been frequent or infrequent.
Based on all of the reasons stated above, the Perceval and INTUITY
valves are no longer considered ``new'' for purposes of new technology
add-on payments for FY 2019. Therefore, after consideration of the
public comments we received, we are finalizing our proposal to
discontinue new technology add-on payments for the Perceval and INTUITY
valves for FY 2019.
c. GORE[supreg] EXCLUDER[supreg] Iliac Branch Endoprosthesis (Gore IBE
Device)
W. L. Gore and Associates, Inc. submitted an application for new
technology add-on payments for the GORE[supreg] EXCLUDER[supreg] Iliac
Branch Endoprosthesis (GORE IBE device) for FY 2017. The device
consists of two components: The Iliac Branch Component (IBC) and the
Internal Iliac Component (IIC). The applicant indicated that each
endoprosthesis is pre-mounted on a customized delivery and deployment
system allowing for controlled endovascular delivery via bilateral
femoral access. According to the applicant, the device is designed to
be used in conjunction with the GORE[supreg] EXCLUDER[supreg] AAA
Endoprosthesis for the treatment of patients requiring repair of common
iliac or aortoiliac aneurysms. When deployed, the GORE IBE device
excludes the common iliac aneurysm from systemic blood flow, while
preserving blood flow in the external and internal iliac arteries.
With regard to the newness criterion, the applicant received FDA
pre-market approval of the GORE IBE device on February 29, 2016. The
following procedure codes describe the use of this technology: 04VC0EZ
(Restriction of right common iliac artery with branched or fenestrated
intraluminal device, one or two arteries, open approach); 04VC3EZ
(Restriction of right common iliac artery with branched or fenestrated
intraluminal device, one or two arteries, percutaneous approach);
04VC4EZ (Restriction of right common iliac artery with branched or
fenestrated intraluminal device, one or two arteries, percutaneous
approach); 04VD0EZ (Restriction of left common iliac artery with
branched or fenestrated intraluminal device, one or two arteries, open
approach); 04VD3EZ (Restriction of left common iliac artery with
branched or fenestrated intraluminal device, one or two arteries,
percutaneous approach); 04VD4EZ (Restriction of left common iliac
artery
[[Page 41280]]
with branched or fenestrated intraluminal device, one or two arteries,
percutaneous endoscopic approach).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for the GORE
IBE device and consideration of the public comments we received in
response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved the
GORE IBE device for new technology add-on payments for FY 2017 (81 FR
56909). With the new technology add-on payment application, the
applicant indicated that the total operating cost of the GORE IBE
device is $10,500. Under Sec. 412.88(a)(2), we limit new technology
add-on payments 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 GORE IBE device is $5,250.
With regard to the newness criterion for the GORE IBE device, we
considered the beginning of the newness period to commence when the
GORE IBE device received FDA approval on February 29, 2016. As
discussed previously in this section, in general, we extend new
technology add-on payments for an additional year only if the 3-year
anniversary date of the product's entry onto the U.S. market occurs in
the latter half of the upcoming fiscal year. Because the 3-year
anniversary date of the entry of the GORE IBE device onto the U.S.
market (February 28, 2019) will occur in the first half of FY 2019, in
the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20282), we proposed to
discontinue new technology add-on payments for this technology for FY
2019. We invited public comments on our proposal to discontinue new
technology add-on payments for the GORE IBE device.
Comment: The applicant (manufacturer) disagreed with CMS' proposal
to discontinue new technology add-on payments for the GORE IBE device,
and recommended that CMS continue new technology add-on payments for an
additional year until sufficient claims data are available to reflect
the cost of the technology. The applicant indicated that the FDA
approval date is the date that the manufacturer may begin
commercialization and actual manufacturing and marketing takes several
months. As such, the applicant believed that it would be more
appropriate to use the date of first sale or the date of the first
procedure as the beginning of the newness period because it would more
appropriately align with the point at which claims and costs data would
begin to become available.
With regard to the GORE IBE device, the applicant noted that there
was a deletion of ICD-10-PCS procedure codes in FY 2018 used for the
coding of procedures identifying the GORE IBE implant, which created
confusion for hospital billing departments that were reporting these
codes. As a result, the applicant believed that the GORE IBE implant
procedures may have been under-reported and the claims data has not
captured the utilization and cost data for these implant procedures.
Additionally, the applicant stated that MACs, as a general practice, do
not include Category III CPT codes in their internal processes and,
specifically, do not include 0254T for the identification of the GORE
IBE procedure. The applicant believed that this lack of alignment
between the new technology add-on payment policy and the MACs'
treatment of Category III CPT codes for the identification of GORE IBE
procedures likely contributed to the severe under-reporting of
procedures involving the GORE IBE implant. Therefore, the applicant
recommended that CMS maintain consistent ICD-10 coding practices,
encourage the MACs to include procedures involving devices for which
new technology add-on payments are effective in their internal
processes, and extend new technology add-on payments for the GORE IBE
technology through FY 2019 to allow assessment of sufficient claims
data that reflect the costs of the GORE IBE device.
Response: We appreciate the applicant's input. As stated above,
while CMS may consider a documented delay in a technology's
availability on the U.S. market in determining when the newness period
begins, its policy for determining whether to extend new technology
add-on payments for an additional year generally applies regardless of
the volume of claims for the technology after the beginning of the
newness period. Similar to our discussion earlier and in the FY 2006
IPPS final rule (70 FR 47349), we do not believe that case volume is a
relevant consideration for making the determination as to whether a
product is considered ``new'' for purposes of new technology add-on
payments. Consistent with the statute and our implementing regulations,
a technology is no longer considered ``new'' once it is more than 2 to
3 years old, and the costs of the procedures are considered to be
included in the relative weights irrespective of how frequently the
technology has been used in the Medicare population. Additionally,
since the technology is on the market coding changes or local coverage
determinations typically do not delay the beginning of the newness
period. Therefore, in this case, because the GORE IBE device has been
available on the U.S. market for more than 2 to 3 years, we consider
claims and costs data to be available for DRG recalibration of the
relative weights, and the costs of the technology to have been included
in the MS-DRG relative weights regardless of whether the technology's
use in the Medicare population has been frequent or infrequent.
Based on the reasons stated above, the GORE IBE device is no longer
considered ``new'' for purposes of new technology add-on payments for
FY 2019. Therefore, after consideration of the public comments we
received, we are finalizing our proposal to discontinue new technology
add-on payments for the GORE IBE device for FY 2019.
d. PRAXBIND (Idarucizumab)
Boehringer Ingelheim Pharmaceuticals, Inc. submitted an application
for new technology add-on payments for FY 2017 for idarucizumab (also
known as PRAXBIND), a product developed as an antidote to reverse the
effects of PRADAXA (dabigatran), which is also manufactured by
Boehringer Ingelheim Pharmaceuticals, Inc.
Dabigatran is an oral direct thrombin inhibitor currently
indicated: (1) To reduce the risk of stroke and systemic embolism in
patients who have been diagnosed with nonvalvular atrial fibrillation
(NVAF); (2) for the treatment of deep venous thrombosis (DVT) and
pulmonary embolism (PE) in patients who have been administered a
parenteral anticoagulant for 5 to 10 days; (3) to reduce the risk of
recurrence of DVT and PE in patients who have been previously treated;
and (4) for the prophylaxis of DVT and PE in patients who have
undergone hip replacement surgery. 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.
PRAXBIND was approved by the FDA on October 16, 2015. PRAXBIND is
indicated for the use in the treatment of
[[Page 41281]]
patients who have been administered PRADAXA when reversal of the
anticoagulant effects of dabigatran is needed for emergency surgery or
urgent medical procedures or in life-threatening or uncontrolled
bleeding.
The applicant was granted approval to use unique ICD-10-PCS
procedure codes that became effective October 1, 2016, to describe the
use of this technology. The approved ICD-10-PCS procedure codes are:
XW03331 (Introduction of idarucizumab, dabigatran reversal agent into
peripheral vein, percutaneous approach, new technology group 1); and
XW04331 (Introduction of idarucizumab, dabigatran reversal agent into
central vein, percutaneous approach, new technology group 1).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
idarucizumab and consideration of the public comments we received in
response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved
idarucizumab for new technology add-on payments for FY 2017 (81 FR
56897). With the new technology add-on payment application, the
applicant indicated that the total operating cost of idarucizumab is
$3,500. Under Sec. 412.88(a)(2), we limit new technology add-on
payments 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 a case involving idarucizumab is $1,750.
With regard to the newness criterion for idarucizumab, we
considered the beginning of the newness period to commence when
PRAXBIND was approved by the FDA on October 16, 2015. As discussed
previously in this section, in general, we extend new technology add-on
payments for an additional year only if the 3-year anniversary date of
the product's entry onto the U.S. market occurs in the latter half of
the upcoming fiscal year. Because the 3-year anniversary date of the
entry of PRAXBIND onto the U.S. market will occur in the first half of
FY 2019 (October 15, 2018), in the FY 2019 IPPS/LTCH PPS proposed rule
(83 FR 20282), we proposed to discontinue new technology add-on
payments for this technology for FY 2019. We invited public comments on
our proposal to discontinue new technology add-on payments for
idarucizumab.
Comment: A few commenters supported CMS' proposal to discontinue
new technology add-on payments for FY 2019 for idarucizumab.
Response: We appreciate the commenters' support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for idarucizumab
for FY 2019.
e. Stelara[supreg] (Ustekinumab)
Janssen Biotech submitted an application for new technology add-on
payments for the Stelara[supreg] induction therapy for FY 2018.
Stelara[supreg] received FDA approval as an intravenous (IV) infusion
treatment for adult patients with moderately to severe active Crohn's
disease (CD) who have failed or were intolerant to treatment using
immunomodulators or corticosteroids, but never failed a tumor necrosis
factor (TNF) blocker, or failed or were intolerant to treatment using
one or more TNF blockers. The FDA approved Stelara[supreg] on September
23, 2016. Stelara[supreg] IV is intended for induction--subcutaneous
prefilled syringes are intended for maintenance dosing. Stelara[supreg]
must be administered intravenously by a health care professional in
either an inpatient hospital setting or an outpatient hospital setting.
Stelara[supreg] for IV infusion is packaged in single 130 mg vials.
Induction therapy consists of a single IV infusion dose using the
following weight-based dosing regimen: Patients weighing less than
(<)55 kg are administered 260 mg of Stelara[supreg] (2 vials); patients
weighing more than (>)55 kg, but less than (<)85 kg are administered
390 mg of Stelara[supreg] (3 vials); and patients weighing more than
(>)85 kg are administered 520 mg of Stelara[supreg] (4 vials). An
average dose of Stelara[supreg] administered through IV infusion is 390
mg (3 vials). Maintenance doses of Stelara[supreg] are administered at
90 mg, subcutaneously, at 8-week intervals and may occur in the
outpatient hospital setting.
CD is an inflammatory bowel disease of unknown etiology,
characterized by transmural inflammation of the gastrointestinal (GI)
tract. Symptoms of CD may include fatigue, prolonged diarrhea with or
without bleeding, abdominal pain, weight loss and fever. CD can affect
any part of the GI tract including the mouth, esophagus, stomach, small
intestine, and large intestine. Conventional pharmacologic treatments
of CD include antibiotics, mesalamines, corticosteroids,
immunomodulators, tumor necrosis alpha (TNF[alpha]) inhibitors, and
anti-integrin agents. Surgery may be necessary for some patients
diagnosed with CD in which conventional therapies have failed.
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
Stelara[supreg] and consideration of the public comments we received in
response to the FY 2018 IPPS/LTCH PPS proposed rule, we approved
Stelara[supreg] for new technology add-on payments for FY 2018 (82 FR
38129). Cases involving Stelara[supreg] that are eligible for new
technology add-on payments are identified by ICD-10-PCS procedure code
XW033F3 (Introduction of other New Technology therapeutic substance
into peripheral vein, percutaneous approach, new technology group 3).
With the new technology add-on payment application, the applicant
estimated that the average Medicare beneficiary would require a dosage
of 390 mg (3 vials) at a hospital acquisition cost of $1,600 per vial
(for a total of $4,800). Under Sec. 412.88(a)(2), we limit new
technology add-on payments 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 amount for a case involving the use of Stelara[supreg] is
$2,400.
With regard to the newness criterion for Stelara[supreg], we
considered the beginning of the newness period to commence when
Stelara[supreg] received FDA approval as an IV infusion treatment of
Crohn's disease (CD) on September 23, 2016. Because the 3-year
anniversary date of the entry of Stelara[supreg] onto the U.S. market
(September 23, 2019) will occur after FY 2019, in the FY 2019 IPPS/LTCH
PPS proposed rule (83 FR 20282 through 20283) we proposed to continue
new technology add-on payments for this technology for FY 2019. We
proposed that the maximum payment for a case involving Stelara[supreg]
would remain at $2,400 for FY 2019. We invited public comments on our
proposal to continue new technology add-on payments for Stelara[supreg]
for FY 2019.
Comment: A few commenters supported CMS' proposal to continue new
technology add-on payments for Stelara[supreg] for FY 2019. In
addition, the applicant (manufacturer) also agreed with CMS' proposal
to continue new technology add-on payments for the Stelara[supreg] for
FY 2019, and noted that because the technology's 3-year anniversary
date of the product's entry onto the U.S. market would not occur until
September 23, 2019, it is appropriate to continue new technology add-on
payments for FY 2019.
Response: We appreciate the commenters' support. After
consideration of the public comments
[[Page 41282]]
we received, we are finalizing our proposal to continue new technology
add-on payments for Stelara[supreg] for FY 2019. The maximum payment
for a case involving Stelara[supreg] will remain at $2,400 for FY 2019.
f. VistogardTM (Uridine Triacetate)
BTG International Inc. submitted an application for new technology
add-on payments for the VistogardTM for FY 2017.
VistogardTM was developed as an emergency treatment for
fluorouracil or capecitabine overdose regardless of the presence of
symptoms and for those who exhibit early-onset, severe, or life-
threatening toxicity.
Chemotherapeutic agent 5-fluorouracil (5-FU) is used to treat
specific solid tumors. It acts upon deoxyribonucleic acid (DNA) and
ribonucleic acid (RNA) in the body, as uracil is a naturally occurring
building block for genetic material. Fluorouracil is a fluorinated
pyrimidine. As a chemotherapy agent, fluorouracil is absorbed by cells
and causes the cell to metabolize into byproducts that are toxic and
used to destroy cancerous cells. According to the applicant, the
byproducts fluorodoxyuridine monophosphate (F-dUMP) and floxuridine
triphosphate (FUTP) are believed to do the following: (1) Reduce DNA
synthesis; (2) lead to DNA fragmentation; and (3) disrupt RNA
synthesis. Fluorouracil is used to treat a variety of solid tumors such
as colorectal, head and neck, breast, and ovarian cancer. With
different tumor treatments, different dosages, and different dosing
schedules, there is a risk for toxicity in these patients. Patients may
suffer from fluorouracil toxicity/death if 5-FU is delivered in slight
excess or at faster infusion rates than prescribed. The cause of
overdose can happen for a variety of reasons including: Pump
malfunction, incorrect pump programming or miscalculated doses, and
accidental or intentional ingestion.
VistogardTM is an antidote to fluorouracil toxicity and
is a prodrug of uridine. Once the drug is metabolized into uridine, it
competes with the toxic byproduct FUTP in binding to RNA, thereby
reducing the impact FUTP has on cell death.
With regard to the newness criterion, VistogardTM
received FDA approval on December 11, 2015. However, as discussed in
the FY 2017 IPPS/LTCH PPS final rule (81 FR 56910), due to the delay in
VistogardTM's commercial availability, we considered the
newness period to begin March 2, 2016, instead of December 11, 2015.
The applicant noted that the VistogardTM is the first FDA-
approved antidote used to reverse fluorouracil toxicity. The applicant
submitted a request for a unique ICD-10-PCS procedure code and was
granted approval for the following procedure code: XW0DX82
(Introduction of Uridine Triacetate into Mouth and Pharynx, External
Approach, new technology group 2). The new code became effective on
October 1, 2016.
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
VistogardTM and consideration of the public comments we
received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we
approved VistogardTM for new technology add-on payments for
FY 2017 (81 FR 56912). With the new technology add-on payment
application, the applicant stated that the total operating cost of
VistogardTM is $75,000. Under Sec. 412.88(a)(2), we limit
new technology add-on payments 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 a case involving VistogardTM
is $37,500.
With regard to the newness criterion for the
VistogardTM, we considered the beginning of the newness
period to commence upon the entry of VistogardTM onto the
U.S. market on March 2, 2016. As discussed previously in this section,
in general, we extend new technology add-on payments for an additional
year only if the 3-year anniversary date of the product's entry onto
the U.S. market occurs in the latter half of the upcoming fiscal year.
Because the 3-year anniversary date of the entry of the
VistogardTM onto the U.S. market (March 2, 2019) will occur
in the first half of FY 2019, in the FY 2019 IPPS/LTCH PPS proposed
rule (83 FR 20283), we proposed to discontinue new technology add-on
payments for this technology for FY 2019. We invited public comments on
our proposal to discontinue new technology add-on payments for the
VistogardTM.
Comment: A few commenters supported CMS' proposal to discontinue
new technology add-on payments for FY 2019 for VistogardTM.
Response: We appreciate the commenters' support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for
VistogardTM for FY 2019.
g. ZINPLAVATM (Bezlotoxumab)
Merck & Co., Inc. submitted an application for new technology add-
on payments for ZINPLAVATM for FY 2018.
ZINPLAVATM is indicated to reduce recurrence of Clostridium
difficile infection (CDI) in adult patients who are receiving
antibacterial drug treatment for a diagnosis of CDI who are at high
risk for CDI recurrence. ZINPLAVATM is not indicated for the
treatment of the presenting episode of CDI and is not an antibacterial
drug.
Clostridium difficile (C-diff) is a disease-causing anaerobic,
spore forming bacteria that can affect the gastrointestinal (GI) tract.
Some people carry the C-diff bacterium in their intestines, but never
develop symptoms of an infection. The difference between asymptomatic
colonization and pathogenicity is caused primarily by the production of
an enterotoxin (Toxin A) and/or a cytotoxin (Toxin B). The presence of
either or both toxins can lead to symptomatic CDI, which is defined as
the acute onset of diarrhea with a documented infection with toxigenic
C-diff, or the presence of either toxin A or B. The GI tract contains
millions of bacteria, commonly referred to as ``normal flora'' or
``good bacteria,'' which play a role in protecting the body from
infection. Antibiotics can kill these good bacteria and allow the C-
diff bacteria to multiply and release toxins that damage the cells
lining the intestinal wall, resulting in a CDI. CDI is a leading cause
of hospital-associated gastrointestinal illnesses. Persons at increased
risk for CDI include people who are treated with current or recent
antibiotic use, people who have encountered current or recent
hospitalization, people who are older than 65 years, immunocompromised
patients, and people who have recently had a diagnosis of CDI. CDI
symptoms include, but are not limited to, diarrhea, abdominal pain, and
fever. CDI symptoms range in severity from mild (abdominal discomfort,
loose stools) to severe (profuse, watery diarrhea, severe pain, and
high fevers). Severe CDI can be life-threatening and, in rare cases,
can cause bowel rupture, sepsis and organ failure. CDI is responsible
for 14,000 deaths per year in the United States.
C-diff produces two virulent, pro-inflammatory toxins, Toxin A and
Toxin B, which target host colonocytes (that is, large intestine
endothelial cells) by binding to endothelial cell surface receptors via
combined repetitive oligopeptide (CROP) domains. These toxins cause the
release of inflammatory cytokines leading to intestinal fluid secretion
and intestinal inflammation. The applicant asserted that
ZINPLAVATM targets Toxin B sites within the CROP domain
rather than the
[[Page 41283]]
C-diff organism itself. According to the applicant, by targeting C-diff
Toxin B, ZINPLAVATM neutralizes Toxin B, prevents large
intestine endothelial cell inflammation, symptoms associated with CDI,
and reduces the recurrence of CDI.
ZINPLAVATM received FDA approval on October 21, 2016,
for reduction of recurrence of CDI in adult patients receiving
antibacterial drug treatment for CDI and who are at high risk of CDI
recurrence. ZINPLAVATM became commercially available on
February 10, 2017. Therefore, the newness period for
ZINPLAVATM began on February 10, 2017. The applicant
submitted a request for a unique ICD-10-PCS procedure code and was
granted approval for the following procedure codes: XW033A3
(Introduction of bezlotoxumab monoclonal antibody, into peripheral
vein, percutaneous approach, new technology group 3) and XW043A3
(Introduction of bezlotoxumab monoclonal antibody, into central vein,
percutaneous approach, new technology group 3).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
ZINPLAVATM and consideration of the public comments we
received in response to the FY 2018 IPPS/LTCH PPS proposed rule, we
approved ZINPLAVATM for new technology add-on payments for
FY 2018 (82 FR 38119). With the new technology add-on payment
application, the applicant estimated that the average Medicare
beneficiary would require a dosage of 10mg/kg of ZINPLAVATM
administered as an IV infusion over 60 minutes as a single dose.
According to the applicant, the WAC for one dose is $3,800. Under Sec.
412.88(a)(2), we limit new technology add-on payments 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 amount for a case involving the
use of ZINPLAVATM is $1,900.
With regard to the newness criterion for ZINPLAVATM, we
considered the beginning of the newness period to commence on February
10, 2017. Because the 3-year anniversary date of the entry of
ZINPLAVATM onto the U.S. market (February 10, 2020) will
occur after FY 2019, in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20283 through 20284), we proposed to continue new technology add-on
payments for this technology for FY 2019. We proposed that the maximum
payment for a case involving ZINPLAVATM would remain at
$1,900 for FY 2019. We invited public comments on our proposal to
continue new technology add-on payments for ZINPLAVATM for
FY 2019.
Comment: A few commenters supported CMS' proposal to continue new
technology add-on payments for ZINPLAVATM for FY 2019.
Response: We appreciate the commenters' support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for
ZINPLAVATM for FY 2019. The maximum new technology add-on
payment for a case involving ZINPLAVATM will remain at
$1,900 for FY 2019.
5. FY 2019 Applications for New Technology Add-On Payments
We received 15 applications for new technology add-on payments for
FY 2019. In accordance with the regulations under Sec. 412.87(c),
applicants for new technology add-on payments must have FDA approval or
clearance by July 1 of the year prior to the beginning of the fiscal
year that the application is being considered. Since the issuance of
the FY 2019 IPPS/LTCH PPS proposed rule, three applicants, Progenics
Pharmaceuticals, Inc. (the applicant for AZEDRA[supreg]), Somahlution,
Inc. (the applicant for DURAGRAFT[supreg]), and TherOx, Inc. (the
applicant for Supersaturated Oxygen (SSO2) Therapy),
withdrew their applications. One applicant, Isoray Medical, Inc. and GT
Medical Technologies, Inc. (the applicant for GammaTileTM),
did not meet the deadline of July 1 for FDA approval or clearance of
the technology and, therefore, the technology is not eligible for
consideration for new technology add-on payments for FY 2019. A
discussion of the remaining 11 applications is presented below.
a. KYMRIAH[supreg] (Tisagenlecleucel) and YESCARTA[supreg]
(Axicabtagene Ciloleucel)
Two manufacturers, Novartis Pharmaceuticals Corporation and Kite
Pharma, Inc. submitted separate applications for new technology add-on
payments for FY 2019 for KYMRIAH (tisagenlecleucel) and YESCARTA
(axicabtagene ciloleucel), respectively. Both of these technologies are
CD-19-directed T-cell immunotherapies used for the purposes of treating
patients with aggressive variants of non-Hodgkin lymphoma (NHL). In the
FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20284), we noted that
KYMRIAH was approved by the FDA on August 30, 2017, for use in the
treatment of patients up to 25 years of age with B-cell precursor acute
lymphoblastic leukemia (ALL) that is refractory or in second or later
relapse, which is a different indication and patient population than
the new indication and targeted patient population for which the
applicant submitted a request for approval of new technology add-on
payments for FY 2019. Specifically, and as summarized in a table
presented in the proposed rule and updated in the following table
presented in this final rule, the new indication for which Novartis
Pharmaceuticals Corporation is requesting approval for new technology
add-on payments for KYMRIAH is as an autologous T-cell immune therapy
indicated for use in the treatment of patients with relapsed/refractory
(r/r) diffuse large B-Cell lymphoma after two or more lines of systemic
therapy including diffuse large B-cell lymphoma (DLBCL) not eligible
for autologous stem cell transplant (ASCT). In addition, we indicated
that as of the time of the development of the proposed rule, Novartis
Pharmaceuticals Corporation had been granted Breakthrough Therapy
designation by the FDA, and was awaiting FDA approval for the use of
KYMRIAH under this new indication. The updated table that follows
reflects that Novartis Pharmaceuticals Corporation received FDA
approval for the use of KYMRIAH under this new indication on May 1,
2018. We also noted that Kite Pharma, Inc. previously submitted an
application for approval for new technology add-on payments for FY 2018
for KTE-C19 for use as an autologous T-cell immune therapy in the
treatment of adult patients with r/r aggressive B-cell NHL who are
ineligible for ASCT. However, Kite Pharma, Inc. withdrew its
application for KTE-C19 prior to publication of the FY 2018 IPPS/LTCH
PPS final rule. Kite Pharma, Inc. resubmitted an application for
approval for new technology add-on payments for FY 2019 for KTE-C19
under a new name, YESCARTA, for the same indication. Kite Pharma, Inc.
received FDA approval for this original indication and treatment use of
YESCARTA on October 18, 2017. (We refer readers to the following
updated table for a comparison of the indications and FDA approvals for
KYMRIAH and YESCARTA).
[[Page 41284]]
Comparison of Indication and FDA Approval for KYMRIAH and YESCARTA
----------------------------------------------------------------------------------------------------------------
Description of indication for which new
FY 2019 applicant technology name technology add-on payments are being FDA approval status
requested
----------------------------------------------------------------------------------------------------------------
KYMRIAH (Novartis Pharmaceuticals KYMRIAH: Autologous T-cell immune therapy FDA approval received
Corporation). indicated for use in the treatment of 5/1/2018.
patients with relapsed/refractory (r/r)
large B-cell lymphoma after two or more
lines of systemic therapy including
diffuse large B cell lymphoma (DLBCL) not
eligible for autologous stem cell
transplant (ASCT).
YESCARTA (Kite Pharma, Inc.)............ YESCARTA: Autologous T-cell immune therapy FDA approval received
indicated for use in the treatment of 10/18/2017.
adult patients with r/r large B-cell
lymphoma after two or more lines of
systemic therapy, including DLBCL not
otherwise specified, primary mediastinal
large B-cell, high grade B-cell lymphoma,
and DLBCL arising from follicular
lymphoma.
----------------------------------------------------------------------------------------------------------------
Technology approved for other FDA approval of other
indications Description of other indication indication
----------------------------------------------------------------------------------------------------------------
KYMRIAH (Novartis Pharmaceuticals KYMRIAH: CD-19[dash]directed T-cell FDA approval received
Corporation). immunotherapy indicated for the use in 8/30/2017.
the treatment of patients up to 25 years
of age with B-cell precursor ALL that is
refractory or in second or later relapse.
YESCARTA (Kite Pharma, Inc.)............ None...................................... N/A.
----------------------------------------------------------------------------------------------------------------
We note that procedures involving the KYMRIAH and YESCARTA
therapies are both reported using the following ICD-10-PCS procedure
codes: XW033C3 (Introduction of engineered autologous chimeric antigen
receptor t-cell immunotherapy into peripheral vein, percutaneous
approach, new technology group 3); and XW043C3 (Introduction of
engineered autologous chimeric antigen receptor t-cell immunotherapy
into central vein, percutaneous approach, new technology group 3). We
further note that, in section II.F.2.d. of the preamble of this final
rule, we are finalizing our proposal to assign cases reporting these
ICD-10-PCS procedure codes to Pre-MDC MS-DRG 016 for FY 2019 and to
revise the title of this MS-DRG to (Autologous Bone Marrow Transplant
with CC/MCC or T-cell Immunotherapy). We refer readers to section
II.F.2.d. of the preamble of this final rule for a complete discussion
of these final policies.
According to the applicants, patients with NHL represent a
heterogeneous group of B-cell malignancies with varying patterns of
behavior and response to treatment. B-cell NHL can be classified as
either an aggressive, or indolent disease, with aggressive variants
including DLBCL; primary mediastinal large B-cell lymphoma (PMBCL); and
transformed follicular lymphoma (TFL). Within diagnoses of NHL, DLBCL
is the most common subtype of NHL, accounting for approximately 30
percent of patients who have been diagnosed with NHL, and survival
without treatment is measured in months.\6\ Despite improved therapies,
only 50 to 70 percent of newly diagnosed patients are cured by standard
first-line therapy alone. Furthermore, r/r disease continues to carry a
poor prognosis because only 50 percent of patients are eligible for
autologous stem cell transplantation (ASCT) due to advanced age, poor
functional status, comorbidities, inadequate social support for
recovery after ASCT, and provider or patient choice.\7\ \8\ \9\ \10\ Of
the roughly 50 percent of patients that are eligible for ASCT, nearly
50 percent fail to respond to prerequisite salvage chemotherapy and
cannot undergo ASCT.\11\ \12\ \13\ \14\ Second-line chemotherapy
regimens studied to date include rituximab, ifosfamide, carboplatin and
etoposide (R-ICE), and rituximab, dexamethasone, cytarabine, and
cisplatin (R-DHAP), followed by consolidative high-dose therapy (HDT)/
ASCT. Both regimens offer similar overall response rates (ORR) of 51
percent with 1 in 4 patients achieving long-term complete response (CR)
at the expense of increased toxicity.\15\ Second-line treatment with
dexamethasone, high-dose cytarabine, and cisplatin (DHAP) is considered
a standard chemotherapy regimen, but is associated with substantial
treatment-related toxicity.\16\ For patients who experience disease
progression during or after primary treatment, the combination of HDT/
ASCT remains the only curative option.\17\ According to the applicants,
given the modest response to second-line therapy and/or HDT/ASCT, the
population of patients with the highest unmet need is those with
chemorefractory disease, which include DLBCL, PMBCL, and TFL. These
[[Page 41285]]
patients are defined as either progressive disease (PD) as best
response to chemotherapy, stable disease as best response following
greater than or equal to 4 cycles of first-line or 2 cycles of later-
line therapy, or relapse within less than or equal to 12 months of
ASCT.\18\ Based on these definitions and available data from a multi-
center retrospective study (SCHOLAR-1), chemorefractory disease treated
with current and historical standards of care has consistently poor
outcomes with an ORR of 26 percent and median overall survival (OS) of
6.3 months.\19\
---------------------------------------------------------------------------
\6\ Chaganti, S., et al., ``Guidelines for the management of
diffuse large B-cell lymphoma,'' BJH Guideline, 2016. Available at:
www.bit.do/bsh-guidelines.
\7\ Matasar, M., et al., ``Ofatumumab in combination with ICE or
DHAP chemotherapy in relapsed or refractory intermediate grade B-
cell lymphoma,'' Blood, 25 July 2013, vol. 122, No 4.
\8\ Hitz, F., et al., ``Outcome of patients with chemotherapy
refractory and early progressive diffuse large B cell lymphoma after
R-CHOP treatment,'' Blood (American Society of Hematology (ASH)
annual meeting abstracts, poster session), 2010, pp. 116 (abstract
#1751).
\9\ Telio, D., et al., ``Salvage chemotherapy and autologous
stem cell transplant in primary refractory diffuse large B-cell
lymphoma: outcomes and prognostic factors,'' Leukemia & Lymphoma,
2012, vol. 53(5), pp. 836-41.
\10\ Moskowitz, C.H., et al., ``Ifosfamide, carboplatin, and
etoposide: a highly effective cytoreduction and peripheral-blood
progenitor-cell mobilization regimen for transplant-eligible
patients with non-Hodgkin's lymphoma,'' Journal of Clinical
Oncology, 1999, vol. 17(12), pp. 3776-85.
\11\ Crump, M., et al., ``Outcomes in patients with refractory
aggressive diffuse large B-cell lymphoma (DLBCL): results from the
international scholar-1 study,'' Abstract and poster presented at
Pan Pacific Lymphoma Conference (PPLC), July 2016.
\12\ Gisselbrecht, C., et al., ``Results from SCHOLAR-1:
outcomes in patients with refractory aggressive diffuse large B-cell
lymphoma (DLBCL),'' Oral presentation at European Hematology
Association conference, July 2016.
\13\ Iams, W., Reddy, N., ``Consolidative autologous
hematopoietic stem-cell transplantation in first remission for non-
Hodgkin lymphoma: current indications and future perspective,'' Ther
Adv Hematol, 2014, vol. 5(5), pp. 153-67.
\14\ Kantoff, P.W., et al., ``Sipuleucel-T immunotherapy for
castration-resistant prostate cancer,'' N Engl J Med, 2010, vol.
363, pp. 411-422.
\15\ Rovira, J., Valera, A., Colomo, L., et al., ``Prognosis of
patients with diffuse large B cell lymphoma not reaching complete
response or relapsing after frontline chemotherapy or
immunochemotherapy,'' Ann Hematol, 2015, vol. 94(5), pp. 803-812.
\16\ Swerdlow, S.H., Campo, E., Pileri, S.A., et al., ``The 2016
revision of the World Health Organization classification of lymphoid
neoplasms,'' Blood, 2016, vol. 127(20), pp. 2375-2390.
\17\ Koristka, S., Cartellieri, M., Arndt, C., et al., ``Tregs
activated by bispecific antibodies: killers or suppressors?,''
OncoImmunology, 2015, vol. (3):e994441, DOI: 10.4161/
2162402X.2014.994441.
\18\ Crump, M., Neelapu, S.S., Farooq, U., et al., ``Outcomes in
refractory diffuse large B-cell lymphoma: results from the
international SCHOLAR-1 study,'' Blood, Published online: August 3,
2017, doi: 10.1182/blood-2017-03-769620.
\19\ Ibid.
---------------------------------------------------------------------------
According to Novartis Pharmaceuticals Corporation, the recent FDA
approval (on May 1, 2018) for the additional indication allows KYMRIAH
to be used for the treatment of patients with R/R DLBCL who are not
eligible for ASCT. Novartis Pharmaceuticals Corporation describes
KYMRIAH as a CD-19-directed genetically modified autologous T-cell
immunotherapy which utilizes peripheral blood T-cells, which have been
reprogrammed with a transgene encoding, a chimeric antigen receptor
(CAR), to identify and eliminate CD-19-expressing malignant and normal
cells. Upon binding to CD-19-expressing cells, the CAR transmits a
signal to promote T-cell expansion, activation, target cell
elimination, and persistence of KYMRIAH cells. The transduced T-cells
expand in vivo to engage and eliminate CD-19-expressing cells and may
exhibit immunological endurance to help support long-lasting
remission.\20\ \21\ \22\ \23\ At the time the applicant submitted its
application for new technology add-on payments, the applicant conveyed
that no other agent currently used in the treatment of patients with r/
r DLBCL employs gene modified autologous cells to target and eliminate
malignant cells.
---------------------------------------------------------------------------
\20\ KYMRIAHTM [prescribing information], East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2017.
\21\ Kalos, M., Levine, B.L., Porter, D.L., et al., ``T-cells
with chimeric antigen receptors have potent antitumor effects and
can establish memory in patients with advanced leukemia,'' Sci
Transl Med, 2011, vol. 3(95), pp, 95ra73.
\22\ FDA Briefing Document. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566168.pdf.
\23\ Wang, X., Riviere, I., ``Clinical manufacturing of CART
cells: foundation of a promising therapy,'' Mol Ther Oncolytics,
2016, vol. 3, pp. 16015.
---------------------------------------------------------------------------
According to Kite Pharma, Inc., YESCARTA is indicated for the use
in the treatment of adult patients with r/r large B-cell lymphoma after
two or more lines of systemic therapy, including DLBCL not otherwise
specified, PMBCL, high grade B-cell lymphoma, and DLBCL arising from
follicular lymphoma. YESCARTA is not indicated for the treatment of
patients with primary central nervous system lymphoma. The applicant
for YESCARTA described the technology as a CD-19-directed genetically
modified autologous T-cell immunotherapy that binds to CD-19-expressing
cancer cells and normal B-cells. These normal B-cells are considered to
be non-essential tissue, as they are not required for patient survival.
According to the applicant, studies demonstrated that following anti-
CD-19 CAR T-cell engagement with CD-19-expressing target cells, the CD-
28 and CD-3-zeta co-stimulatory domains activate downstream signaling
cascades that lead to T-cell activation, proliferation, acquisition of
effector functions and secretion of inflammatory cytokines and
chemokines. This sequence of events leads to the elimination of CD-19-
expressing tumor cells.
Both applicants expressed that their technology is the first
treatment of its kind for the targeted adult population. In addition,
both applicants asserted that their technology is new and does not use
a substantially similar mechanism of action or involve the same
treatment indication as any other currently FDA-approved technology. In
the FY 2019 IPPS/LTCH PPS proposed rule, we noted that, at the time
each applicant submitted its new technology add-on payment application,
neither technology had received FDA approval for the indication for
which the applicant requested approval for the new technology add-on
payment. We indicated that KYMRIAH had been granted Breakthrough
Therapy designation for the use in the treatment of patients for the
additional indication that is the subject of its new technology add-on
application and, as of the time of the development of the proposed
rule, was awaiting FDA approval. As noted previously, the applicant for
KYMRIAH received approval for this additional indication on May 1,
2018. We further noted in the proposed rule that, YESCARTA received FDA
approval for use in the treatment of patients and the indication stated
in its application on October 18, 2017, after each applicant submitted
its new technology add-on payment application.
As noted, according to both applicants, KYMRIAH and YESCARTA are
the first CAR T-cell immunotherapies of their kind. Because potential
cases representing patients who may be eligible for treatment using
KYMRIAH and YESCARTA would group to the same MS-DRGs (because the same
ICD-10-CM diagnosis codes and ICD-10-PCS procedures codes are used to
report treatment using either KYMRIAH or YESCARTA), and we believed
that these technologies 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 disagreed with the applicants and believed
these two technologies are substantially similar to each other and that
it was appropriate to evaluate both technologies as one application for
new technology add-on payments under the IPPS. For these reasons, and
as discussed further below, we stated that we intended to make one
determination regarding approval for new technology add-on payments
that would apply to both applications, and in accordance with our
policy, would use the earliest market availability date submitted as
the beginning of the newness period for both KYMRIAH and YESCARTA.
Several public commenters submitted comments regarding whether the
technologies are substantially similar to each other in response to the
proposed rule and we summarize and respond to the public comments
below.
With respect to the newness criterion, as previously stated,
YESCARTA received FDA approval on October 18, 2017. According to the
applicant, prior to FDA approval, YESCARTA had been available in the
U.S. only on an investigational basis under an investigational new drug
(IND) application. For the same IND patient population, and until
commercial availability, YESCARTA was available under an Expanded
Access Program (EAP) which started on May 17, 2017. The applicant
stated that it did not recover any costs associated with the EAP.
According to the applicant, the first commercial shipment of YESCARTA
was received by a certified treatment center on November 22, 2017. As
discussed previously, KYMRIAH received FDA approval May 1, 2018, for
use in the treatment of patients diagnosed with r/r DLBCL that are not
eligible for ASCT. Additionally, as noted in the proposed rule, KYMRIAH
was previously granted Breakthrough Therapy designation by the FDA. We
stated in the proposed rule that we believe that, in accordance with
our policy, if these technologies are substantially similar to each
other, it is appropriate to use the earliest market
[[Page 41286]]
availability date submitted as the beginning of the newness period for
both technologies. Therefore, based on our policy, with regard to both
technologies, if the technologies are approved for new technology add-
on payments, we stated that we believe that the beginning of the
newness period would be November 22, 2017.
We stated in the proposed rule that, because we believe these two
technologies are substantially similar to each other, we believe it is
appropriate to evaluate both technologies as one application for new
technology add-on payments under the IPPS. The applicants submitted
separate cost and clinical data, and we reviewed and discussed each set
of data separately. However, we stated that we intended to make one
determination regarding new technology add-on payments that would apply
to both applications. We stated that 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 we believe that continuing our current
practice of extending new technology add-on payments 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 to submit separate new technology add-on payment 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).
We stated that, if substantially similar technologies are submitted
for review in different (and subsequent) 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, we stated that, because the technologies have
been submitted for review in the same year and we believe they are
substantially similar to each other, we believe that it is appropriate
to consider both sets of cost data and clinical data in making a
determination, and we do not believe that it is possible to choose one
set of data over another set of data in an objective manner. We
received public comments regarding our proposal to evaluate KYMRIAH and
YESCARTA as one application for new technology add-on payments under
the IPPS and we summarize and respond to these public comments below.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20284), we stated
that we believe that KYMRIAH and YESCARTA are substantially similar to
each other for purposes of analyzing these two applications as one
application. As discussed in the proposed rule, we stated that we also
need to determine whether KYMRIAH and YESCARTA are substantially
similar to existing technologies prior to their approval by the FDA and
their release onto the U.S. market. As discussed earlier, if a
technology meets all three of the substantial similarity 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, whether a product uses the
same or a similar mechanism of action to achieve a therapeutic outcome,
the applicant for KYMRIAH asserted that its unique design, which
utilizes features that were not previously included in traditional
cytotoxic chemotherapeutic or immunotherapeutic agents, constitutes a
new mechanism of action. The deployment mechanism allows for
identification and elimination of CD-19-expressing malignant and non-
malignant cells, as well as possible immunological endurance to help
support long-lasting remission.\24\ \25\ \26\ \27\ The applicant
provided context regarding how KYMRIAH's unique design contributes to a
new mechanism of action by explaining that peripheral blood T-cells,
which have been reprogrammed with a transgene encoding, a CAR, identify
and eliminate CD-19-expressing malignant and nonmalignant cells. As
explained by the applicant, upon binding to CD-19-expressing cells, the
CAR transmits a signal to promote T-cell expansion, activation, target
cell elimination, and persistence of KYMRIAH cells.\28\ \29\ \30\
According to the applicant, transduced T-cells expand in vivo to engage
and eliminate CD-19-expressing cells and may exhibit immunological
endurance to help support long-lasting remission.\31\ \32\ \33\
---------------------------------------------------------------------------
\24\ KYMRIAH [prescribing information]. East Hanover, NJ:
Novartis Pharmaceuticals Corp; 2017.
\25\ Kalos, M., Levine, B.L., Porter, D.L., et al., ``T cells
with chimeric antigen receptors have potent antitumor effects and
can establish memory in patients with advanced leukemia,'' Sci
Transl Med, 2011, vol. 3(95), pp. 95ra73.
\26\ FDA Briefing Document. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566168.pdf.
\27\ Maude, S.L., Frey, N., Shaw, P.A., et al., ``Chimeric
antigen receptor T cells for sustained remissions in leukemia,'' N
Engl J Med, 2014, vol. 371(16), pp. 1507-1517.
\28\ KYMRIAHTM [prescribing information], East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2017.
\29\ Kalos, M., Levine, B.L., Porter, D.L., et al., ``T-cells
with chimeric antigen receptors have potent antitumor effects and
can establish memory in patients with advanced leukemia,'' Sci
Transl Med, 2011, 3(95), pp, 95ra73.
\30\ FDA Briefing Document. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566168.pdf.
\31\ Kalos, M., Levine, B.L., Porter, D.L., et al., ``T cells
with chimeric antigen receptors have potent antitumor effects and
can establish memory in patients with advanced leukemia,'' Sci
Transl Med, 2011, vol. 3(95), pp. 95rs73.
\32\ FDA Briefing Document. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566168.pdf.
\33\ Maude, S.L., Frey, N., Shaw, P.A., et al., ``Chimeric
antigen receptor T-cells for sustained remissions in leukemia,'' N
Engl J Med, 2014, vol. 371(16) pp. 1507-1517.
---------------------------------------------------------------------------
The applicant for YESCARTA stated that YESCARTA is the first
engineered autologous cellular immunotherapy comprised of CAR T-cells
that recognizes CD-19 express cancer cells and normal B-cells with
efficacy in patients with r/r large B-cell lymphoma after two or more
lines of systemic therapy, including DLBCL not otherwise specified,
PMBCL, high grade B-cell lymphoma, and DLBCL arising from follicular
lymphoma as demonstrated in a multi-centered clinical trial. Therefore,
the applicant believed that YESCARTA's mechanism of action is distinct
and unique from any other cancer drug or biologic that is currently
approved for use in the treatment of patients who have been diagnosed
with aggressive B-cell NHL, namely single-agent or combination
chemotherapy regimens. At the time of the development of the proposed
rule, the applicant also pointed out that YESCARTA was the only
available therapy that has been granted FDA approval for the treatment
of adult patients with r/r large B-cell lymphoma after two or more
lines of systemic therapy, including DLBCL not otherwise specified,
PMBCL, high grade B-cell lymphoma, and DLBCL arising from follicular
lymphoma.
With respect to the second and third criteria, whether a product is
assigned to the same or a different MS-DRG and 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, the applicant
[[Page 41287]]
for KYMRIAH indicated that the technology is used in the treatment of
the same patient population, and potential cases representing patients
that may be eligible for treatment using KYMRIAH would be assigned to
the same MS-DRGs as cases involving patients with a DLBCL diagnosis.
Potential cases representing patients that may be eligible for
treatment using KYMRIAH map to 437 separate MS-DRGs, with the top 20
MS-DRGs covering approximately 68 percent of all patients who have been
diagnosed with DLBCL. For patients with DLBCL and who have received
chemotherapy during their hospital stay, the target population mapped
to 8 separate MS-DRGs, with the top 2 MS-DRGs covering over 95 percent
of this population: MS-DRGs 847 (Chemotherapy without Acute Leukemia as
Secondary Diagnosis with CC), and 846 (Chemotherapy without Acute
Leukemia as Secondary Diagnosis with MCC). The applicant for YESCARTA
submitted findings that potential cases representing patients that may
be eligible for treatment using YESCARTA span 15 unique MS-DRGs, 8 of
which contain more than 10 cases. The most common MS-DRGs were: MS-DRGs
840 (Lymphoma and Non-Acute Leukemia with MCC), 841 (Lymphoma and Non-
Acute Leukemia with CC), and 823 (Lymphoma and Non-Acute Leukemia with
other O.R. Procedures with MCC). These 3 MS-DRGs accounted for 628 (76
percent) of the 827 cases. While the applicants for KYMRIAH and
YESCARTA submitted different findings regarding the most common MS-DRGs
to which potential cases representing patients who may be eligible for
treatment involving their technology would map, we stated in the
proposed rule that we believe that, under the current MS-DRGs (FY
2018), potential cases representing patients who may be eligible for
treatment involving either KYMRIAH or YESCARTA would map to the same
MS-DRGs because the same ICD-10-CM diagnosis codes and ICD-10-PCS
procedures codes will be used to report cases for patients who may be
eligible for treatment involving KYMRIAH and YESCARTA. Furthermore, as
noted above, we proposed, and are finalizing, that cases reporting
these ICD-10-PCS procedure codes would be assigned to MS-DRG 016 for FY
2019. Therefore, under this proposal (and our finalized policy), for FY
2019, cases involving the utilization of KYMRIAH and YESCARTA would
continue to map to the same MS-DRGs.
The applicant for YESCARTA also addressed the concern expressed by
CMS in the FY 2018 IPPS/LTCH PPS proposed rule regarding Kite Pharma
Inc.'s FY 2018 new technology add-on payment application for the KTE-
C19 technology (82 FR 19888). At the time, CMS expressed concern that
KTE-C19 may use the same or similar mechanism of action as the Bi-
Specific T-Cell engagers (BiTE) technology. The applicant for YESCARTA
explained that YESCARTA has a unique and distinct mechanism of action
that is substantially different from BiTE's or any other drug or
biologic currently assigned to any MS-DRG in the FY 2016 MedPAR
Hospital Limited Data Set. In providing more detail regarding how
YESCARTA is different from the BiTE technology, the applicant explained
that the BiTE technology is not an engineered autologous T-cell
immunotherapy derived from a patient's own T-cells. Instead, it is a
bi-specific T-cell engager that recognizes CD-19 and CD-3 cancer cells.
Unlike engineered T-cell therapy, BiTE does not have the ability to
enhance the proliferative and cytolytic capacity of T-cells through ex-
vivo engineering. Further, BiTE is approved for the treatment of
patients who have been diagnosed with Philadelphia chromosome-negative
relapsed or refractory B-cell precursor acute lymphoblastic leukemia
(ALL) and is not approved for patients with relapsed or refractory
large B-cell lymphoma, whereas YESCARTA is indicated for use in the
treatment of adult patients with r/r aggressive B-cell NHL who are
ineligible for ASCT.
The applicant for YESCARTA also indicated that its mechanism of
action is not the same or similar to the mechanism of action used by
KYMRIAH's currently available FDA-approved CD-19-directed genetically
modified autologous T-cell immunotherapy indicated for use in the
treatment of patients up to 25 years of age with B-cell precursor acute
lymphoblastic leukemia (ALL) that is refractory or in second or later
relapse.\34\ The applicant for YESCARTA stated that the mechanism of
action is different from KYMRIAH's FDA-approved therapy because the
spacer, transmembrane and co-stimulatory domains of YESCARTA are
different from those of KYMRIAH. The applicant explained that YESCARTA
is comprised of a CD-28 co-stimulatory domain and KYMRIAH has 4-1BB co-
stimulatory domain. Further, the applicant stated the manufacturing
processes of the two immunotherapies are also different, which may
result in cell composition differences leading to possible efficacy and
safety differences.
---------------------------------------------------------------------------
\34\ Food and Drug Administration. Available at:
www.accessdata.fda.gov/scripts/opdlisting/oopd/.
---------------------------------------------------------------------------
We stated in the proposed rule that while the applicant for
YESCARTA stated how its technology is different from KYMRIAH, because
both technologies are CD-19-directed T-cell immunotherapies used for
the purpose of treating patients with aggressive variants of NHL, we
believe that YESCARTA and KYMRIAH are substantially similar treatment
options. Furthermore, in the FY 2019 IPPS/LTCH PPS proposed rule, we
also stated that we were concerned there may be an age overlap (18 to
25) between the two different patient populations for the currently
approved KYMRIAH technology and YESCARTA technology. We stated in the
proposed rule, which was issued prior to the approval for a second
indication (adult patients), that the indication for the KYMRIAH
technology is for use in the treatment of patients who are up to 25
years of age and the YESCARTA technology is indicated for use in the
treatment of adult patients.
We noted in the proposed rule that the applicant asserted that
YESCARTA is not substantially similar to KYMRIAH. We stated that under
this scenario, if both YESCARTA and KYMRIAH meet all of the new
technology add-on payment criteria and are approved for new technology
add-on payments for FY 2019, for purposes of making the new technology
add-on payment, because procedures utilizing either YESCARTA or KYMRIAH
CAR T-cell therapy drugs are reported using the same ICD-10-PCS
procedure codes, in order to accurately pay the new technology add-on
payment to hospitals that perform procedures utilizing either
technology, it may be necessary to use alternative coding mechanisms to
make the new technology add-on payments. In the FY 2019 IPPS/LTCH PPS
proposed rule, CMS invited comments on alternative coding mechanisms to
make the new technology add-on payments, if necessary.
We also invited public comments on whether KYMRIAH and YESCARTA are
substantially similar to existing technologies and whether the
technologies meet the newness criterion.
Comment: The applicants for KYMRIAH and YESCARTA each provided
comments regarding whether KYMRIAH and YESCARTA were substantially
similar to the other, or to any existing technology. Additional
commenters also submitted comments.
[[Page 41288]]
The applicant for YESCARTA stated that it continued to believe each
technology consists of notable differences in the construction, as well
as manufacturing processes and successes that may lead to differences
in activity. The applicant encouraged CMS to evaluate YESCARTA as a
separate new technology add-on payment application and approve separate
new technology add-on payments for YESCARTA, effective October 1, 2018,
and to not move forward with a single new technology add-on payment
evaluation determination that covers both CAR T-cell therapies,
YESCARTA and KYMRIAH. The applicant stated that the transmembrane
domain of YESCARTA is comprised of a fragment of CD-28 co-stimulatory
molecule, including an extracellular hinge domain, which provides
structural flexibility for optimal binding of the target antigen by the
scFV target binding region. The applicant further stated that, in
contrast, KYMRIAH consists of a spacer and a transmembrane domain,
which are derived from CD8-a. The applicant for YESCARTA believed that,
the spacer provides a flexible link between the scFv and the
transmembrane domain, which then accommodates different orientations of
the antigen binding domain upon CD19 antigen recognition. The applicant
stated that these differences in the origin of the transmembrane
component between the YESCARTA and KYMRIAH may be one of the
differences which lead to differentiation in CAR function and resulting
activity between the two CAR constructs, which will be described later
in this section.
The applicant for YESCARTA believed perhaps the most critical
difference between the two technologies, YESCARTA and KYMRIAH, may be
that of the co-stimulatory domains, which connect the extracellular
scFv antigen binding domain to the cytoplasmic CD3-zeta downstream
signaling domain. The applicant explained that, for YESCARTA, the
technology is derived from the intracellular domains of co-stimulatory
protein CD-28. However, for KYMRIAH, in contrast, the technology is
derived from the co-stimulatory protein 4-1BB (CD137). The applicant
believed that, although clear mechanisms are unknown, it is surmised
that the difference in co-stimulatory region of the two CAR products
may be responsible for differences in activity. The applicant stated
that the ongoing hypothesis for these differences are based on
differentially affecting CAR T-cell cytokine production, expansion,
cytotoxicity and persistence after administration.
The applicant for YESCARTA also described an additional concept
regarding the manufacturing process that it believed supported why the
two technologies were different. The applicant explained that both,
YESCARTA and KYMRIAH, are prepared from the patient's peripheral blood
mononuclear cells, which are obtained via a standard leukapheresis
procedure. However, the applicant stated that, with YESCARTA, the
mononuclear cells are then enriched for T-cells and activated with
anti-CD-3 antibody in the presence of IL-2 then transduced with the
replication incompetent y-retroviral vector containing the anti-CD-19
CAR transgene. The applicant further explained that the transduced T-
cells are expanded in cell culture, washed, formulated into a
suspension, and cryopreserved. The applicant for YESCARTA believed
that, in contrast, KYMRIAH uses anti CD-3/anti CD-28 coated magnetic
beads for T-cell enrichment and activation, rather than anti-CD-3
antibody and IL-2, which are removed after CAR T-cell expansion and
prior to harvest. The applicant explained that a further difference in
the manufacturing of KYMRIAH is the use of lentiviral vector in the
anti-CD-19 CAR gene transduction rather than a y-retroviral vector, as
used for YESCARTA in manufacturing. The applicant stated that both y-
retroviral or lentiviral vectors can permanently insert DNA into the
genome. However, lentiviral vectors are capable of transducing
quiescent cells, while y-retroviral vectors require cells in mitosis.
According to the applicant, the manufacturing success in clinical
trials is also different with results showing median turnaround time of
17 days for YESCARTA, with 99 percent success rate versus median
turnaround time of 113 days, with 93 percent success rate for KYMRIAH.
The applicant for YESCARTA further stated that, if CMS decides to
establish one new technology add-on payment determination and approval
for both CAR T-cell therapies, the add-on payments should be structured
to ensure that payment does not hinder access in any way for patients
to receive the most appropriate cell therapy and use of YESCARTA and
KYMRIAH can be uniquely and individually identified in the Medicare
inpatient data.
Other commenters believed that the two CAR T-cell technologies
should be considered as separate new technology add-on payment
applications because the technologies' indications are approved for two
different patient populations and diagnoses. The commenters stated
that, while the approval for one of the diagnoses for adults is the
same for KYMRIAH and YESCARTA, KYMRIAH has also been approved for
treating children and, therefore, that should be reasoning to consider
the application separately. Additionally, commenters stated that the
pricing of both medications varies based on the patient population, and
encouraged CMS to recognize this discrepancy when determining approval
of new technology add-on payment and establishing adequate payments
rates. Commenters agreed with CMS' conclusion that it is appropriate to
consider both sets of cost and clinical data when determining whether
the standard criteria for new technology add-on payments for KYMRIAH
and YESCARTA were met, but also encouraged CMS to consider evaluation
and determination of both technologies as separate applications.
Some commenters disagreed with CMS' views of the YESCARTA and
KYMRIAH with respect to substantial similarity and expressed concerns
with CMS' conclusion that the two CAR T-cell therapies are
substantially similar to each other. The commenters believed that,
because each therapy has received separate FDA Breakthrough
designations, is approved based on separate Biological License
Applications, and may likely be used in the treatment of different
patient populations in different sites of care, consideration for
approval of new technology add-on payments should be based on separate
applications. Commenters further believed that, for purposes of meeting
the newness criterion, each new technology add-on payment application
must be treated as being unique. Despite these concerns, commenters
supported CMS creating a new MS-DRG for procedures and cases
representing patients receiving treatment involving CAR T-cell
therapies, and recognized that each of the CAR T-cell therapies would
be used in the treatment of cases representing patients that would be
assigned to the same MS-DRG.
Several commenters disagreed with CMS' determination that the
applications for KYMRIAH and YESCARTA are similar enough to warrant
consideration as a single new technology add-on payment application,
and recommended CMS consider the applications separately. Commenters
believed that because KYMRIAH received FDA approval for the use in the
treatment of patients diagnosed with
[[Page 41289]]
r/r DLBCL on May 1, 2018, the beginning of the newness period for
KYMRIAH for cases reporting the ICD-10-PCS procedure codes representing
patients diagnosed with r/r DLBCL should not be the same as YESCARTA,
which began November 22, 2017. Commenters stated that equating the two
beginning dates for the start of the newness periods will prematurely
shorten the new technology add-on payment period for KYMRIAH's new
patient population, which commenters believed would wrongfully withhold
anticipated payments from hospitals. Commenters also recommended that,
if CMS finalized its position to consider KYMRIAH and YESCARTA as one
application, to use the approval date for KYMRIAH as the beginning of
the newness period to avoid any inappropriate shortening of the new
technology add-on payment length.
Other commenters further cautioned CMS that combining the new
technology add-on payment applications' evaluation and determination
for these two therapies would create precedent that may make it
unlikely for future CAR T-cell therapies to be considered distinct from
existing CAR T-cell therapies, or substantially similar. As a result,
the commenters believed that, if CMS finalized its proposal to make a
combined decision for KYMRIAH and YESCARTA, it is more likely that
future CAR T-cell therapies will not qualify for new technology add-on
payments. The commenters noted that, to mitigate any potential negative
impact if CMS combines both the applications and makes its
determination, it would be important for CMS to leave open the option
for future CAR T-cell therapies to apply for and receive approval of
new technology add-on payments, regardless of the decision made for the
current applications under consideration.
Some commenters believed that section 1886(d)(5)(K) of the Act does
not appear to clearly authorize CMS to jointly evaluate KYMRIAH and
YESCARTA, which were submitted by separate manufacturers, as separate
new technology add-on payment applications for two different products
approved by FDA under two separate Biologics License Applications with
distinct clinical and cost data submissions. The commenters believed
that CMS' assessment appeared concentrated on a handful of perceived
similarities in the mechanism of action and the patient and disease
categories between the two newly approved CAR T-cell products.
Commenters stated that this focused approach appeared to give little
weight to the distinctions in the manufacturing process and co-
stimulatory domains between the two CAR T-cell therapies, which
obscures the important distinctions in how the different CAR T-cell
technologies have been refined and optimized. The commenters further
stated that CMS' evaluation also does not fully account for the
difference in clinical profiles of these two agents.
Other commenters believed that failure to recognize the legitimate
distinctions and technological innovations reflected by CAR T-cell
therapy--and inherent across different CAR T-cell treatments, such as
KYMRIAH and YESCARTA, could artificially restrict access to new
technology add-on payments for these new and promising technologies.
Commenters recommended CMS encourage development of medical innovation
by applying the new technology add-on payment ``newness'' criterion in
a way that recognizes the unique, novel, and distinct nature of the CAR
T-cell technology.
In evaluating the new technology add-on payment applications for
KYMRIAH and YESCARTA, some commenters believed that CMS may be
overlooking the significant ways these two technologies represent a
substantial medical advancement compared to existing therapies, most of
which patients have already failed, before they go on to receive
treatment involving CAR T-cell therapy. The commenters stated that CMS
appeared to be unduly focusing on the perceived similarities between
the two newly approved CAR T-cell therapies versus the advancement the
technologies represent over existing therapies. The commenters
encouraged CMS to recognize the ways in which KYMRIAH and YESCARTA
significantly differ from existing technologies and to further apply
the ``newness'' eligibility requirement for new technology add-on
payments in a manner that does not unnecessarily discourage the
availability of new technology add-on payments for these newly approved
CAR T-cell therapies that represent significant clinical advantages
over existing treatments.
The applicant for KYMRIAH stated that, at the time it submitted its
new technology add-on payment application and as summarized in the FY
2019 IPPS/LTCH PPS proposed rule, similar to the applicant for
YESCARTA, it believed the two technologies were not substantially
similar to the other, or to other cancer drugs or biologics currently
approved for use in the treatment of aggressive B-cell NHL and,
therefore, met the newness criterion. However, the applicant
acknowledged that, since the date it submitted its new technology add-
on payment application both technologies, YESCARTA and KYMRIAH, have
received FDA approval for the technologies' intended indications. The
applicant for KYMRIAH further indicated that, based on FDA's recent
approval, it agreed with CMS that KYMRIAH is substantially similar to
YESCARTA, as defined by the new technology add-on payment application
evaluation criteria.
The applicant for KYMRIAH detailed how it believed the technology
is substantially similar to YESCARTA with respect to each criterion
pertaining to substantial similarity.
With regard to the first criterion, whether YESCARTA and KYMRIAH
use the same or a similar mechanism of action to achieve a therapeutic
action, the applicant stated that, although KYMRIAH's and YESCARTA's
mechanisms of actions are distinct and unique from any other cancer
drug or biologic that is currently FDA-approved, namely single-agent or
combination chemotherapy regimens, the applicant believed KYMRIAH and
YESCARTA use the same or similar mechanisms of action to achieve the
therapeutic outcome. To further support the assertion that the two
technologies are substantially similar to one another, the applicant
for KYMRIAH also provided the FDA-approved prescribing information
(``12.1 Mechanism of Action'') issued for KYMRIAH and YESCARTA
describing the mechanisms of actions as being the same or similar for
both technologies in the following manner:
[ssquf] KYMRIAH: KYMRIAH is a CD19-directed genetically modified
autologous T cell immunotherapy which involves reprogramming a
patient's own T cells with a transgene encoding a chimeric antigen
receptor (CAR) to identify and eliminate CD-19-expressing malignant and
normal cells. The CAR is comprised of a murine single-chain antibody
fragment which recognizes CD-19 and is fused to intracellular signaling
domains from 4-1BB (CD137) and CD3 zeta. The CD3 zeta component is
critical for initiating T-cell activation and antitumor activity, while
4-1BB enhances the expansion and persistence of KYMRIAH. Upon binding
to CD-19-expressing cells, the CAR transmits a signal to promote T-cell
expansion, activation, target cell elimination, and persistence of the
KYMRIAH cells.
[ssquf] YESCARTA: YESCARTA, a CD-19-directed genetically modified
autologous T-cell immunotherapy, binds to CD-19-expressing cancer cells
and normal B cells. Studies
[[Page 41290]]
demonstrated that following anti-CD-19 CAR T cell engagement with CD-
19-expressing target cells, the CD28 and CD3-zeta co-stimulatory
domains activate downstream signaling cascades that lead to T-cell
activation, proliferation, acquisition of effector functions and
secretion of inflammatory cytokines and chemokines. This sequence of
events leads to killing of CD-19-expressing cells.
In a summary of the FDA-approved prescribing information, the
applicant further noted that, within the FDA-approved prescribing
information, both KYMRIAH and YESCARTA are CD-19-directed genetically
modified autologous T-cell immunotherapies that bind to CD-19-
expressing cancer cells and normal B cells. Upon binding to CD-19-
expressing cells, the respective CARs transmit a signal to promote T
cell expansion, activation, and target cell elimination.
In response to the differences between KYMRIAH and YESCARTA related
to spacer, transmembrane and co-stimulatory domains, which were stated
by the applicant for YESCARTA, the applicant for KYMRIAH believed that,
although there are structural differences that impact aspects of how
the treatment effect is achieved, the overall mechanisms of actions of
the two CAR T-cell therapy products are similar. The applicant
explained that in defining drug classes, the FDA provided guidance that
a class defined by mechanism of action would include drugs that have
similar pharmacologic action at the receptor, membrane or tissue level.
The applicant indicated that KYMRIAH is a cellular immunotherapy
generated by gene modification of autologous donor T-cells. Further,
the applicant for KYMRIAH stated that through the process of apheresis,
leukocytes are harvested from the patient and undergo a process of ex-
vivo gene transfer in which a CAR is introduced by lentiviral
transduction. The applicant further explained that the CAR construct
contains an antigen binding region designed to target CD-19, a co-
stimulatory domain known as 4-1BB and a signaling domain called CD-3-
zeta. The applicant stated that once transferred, the patient's T-cells
will express the CAR construct anti-CD-19 4-1BB/CD-3-zeta, and undergo
ex-vivo expansion. The applicant for KYMRIAH stated that both, KYMRIAH
and YESCARTA, utilize a gene transfer process to modify autologous
patient immune cells with a chimeric antigen receptor capable of
directing immune mediated killing at a pre-specified target. The
applicant further explained that both technologies accomplish their
pharmacological effect through the use of three specialized domains,
which are structurally different, but achieve similar environmental
interactions. The applicant indicated that, in both agents, the antigen
binding domain identifies CD-19 and, therefore, the interaction between
the agent and its environment begins with the same receptor target
interaction. Additionally, the applicant noted that both KYMRIAH and
YESCARTA induce T-cell mediated cell death of the bound tumor cell by
activating the T-cell expressing the CAR through the signaling domain,
which is common to both agents and, therefore, at the tissue level,
both generate a pharmacological impact by producing T-cell mediated
apoptosis. The applicant for KYMRIAH stated that the pharmacological
effect of these two agents is attained through tumor directed expansion
of CAR T-cells and the development of memory T-cells that allow for
potential long-term persistence and immunosurveillance. The applicant
believed that, in both agents, this is achieved through the use of a
co-stimulatory domain, which leads to the secretion of inflammatory
substances such as cytokines, chemokines and growth factors, which
induce T-cell proliferation and differentiation. The applicant for
KYMRIAH stated that, although it agreed with the applicant for
YESCARTA\'\s assertion that 41BB and CD-28 are both structurally and
functionally different and that at a micro level they generate a
different metabolic profile and stimulate different types of memory T-
cell, on a macroscopic level the general impact is ``substantially
similar'' in that the mechanisms of actions allow for expansion and
memory, which yield tumor-directed killing of the target tissue and
memory T-cell generation for longer duration response that can be
expected with a traditional biologic agent. The applicant further
believed that, while the manufacturing process, safety and efficacy
outcomes of any two members of a class of drugs may differ, these
factors do not impact the mechanism of action.
With regard to the second criterion, whether YESCARTA and KYMRIAH
will be assigned to the same or a different MS-DRG, the applicant
stated that this criterion is met because cases representing patients
eligible for treatment involving both, KYMRIAH and YESCARTA, will be
reported using the same ICD-10-PCS procedure codes (XW033C3 and
XW043C3) and will be assigned to the same MS-DRG--Pre-MDC MS-DRG 016
(as discussed in section II.F.2.d. of the preamble of this final rule).
With regard to the third criterion, whether YESCARTA[supreg] and
KYMRIAH[supreg] will be used to treat the same or similar patient
population, the applicant stated that both, KYMRIAH and YESCARTA, are
FDA approved to treat adult patients diagnosed with r/r aggressive B-
cell NHL in the same or similar patient population. The applicant, in
summary, agreed with CMS' conclusion that KYMRIAH is ``substantially
similar'' to YESCARTA, as defined by CMS, because both technologies
are: (1) Intended to treat the same or similar disease in the same or
similar patient population; (2) purposed to achieve the same
therapeutic outcome using the same or similar mechanism of action; and
(3) would be assigned to the same MS-DRGs. However, the applicant
stated that, despite being ``substantially similar'' technologies,
KYMRIAH and YESCARTA are not ``substantially similar'' to any other
existing technology and, therefore, it believed KYMRIAH met the newness
criterion.
Other commenters, generally, agreed that both, KYMRIAH and
YESCARTA, are substantially similar technologies. One commenter stated
that it agreed with CMS' approach on both clinical and policy grounds
because given the promises and perils of both therapies, the
surrounding coverage and payment issues present to be the same and that
will also be the case for the successor drugs expected to soon achieve
FDA approval and enter the U.S. market. The commenter explained that
consideration of KYMRIAH and YESCARTA as one new technology add-on
payment application simplifies the newness test because both
technologies were assigned an ICD-10-PCS procedure code in 2017, and
cases involving the utilization of the technologies and procedures
reporting the ICD-10-PCS procedure codes will be assigned to the same
MS-DRG, effective with the beginning of FY 2019 on October 1, 2018. The
commenter also noted that, CMS indicated that November 22, 2017, would
be the beginning date for the ``newness'' period because it marks the
first delivery of YESCARTA to eligible treatment centers. The commenter
believed this date was somewhat arbitrary, but did not provide an
alternative date for consideration and, therefore, agreed that KYMRIAH
and YESCARTA should be considered together as one new technology add-on
payment application, both technologies met the criterion for newness,
and the newness period appropriately begins on November 22, 2017. The
commenter stated that, if approved for new
[[Page 41291]]
technology add-on payments, this newness period should grant CMS and
the public sufficient time under the MS-DRG recalibration and the new
technology add-on payment policies to determine whether MS-DRG 016 is
an appropriate MS-DRG assignment for payment of CAR T-cell therapies.
Response: We appreciate all the commenters' input and the
additional detail regarding whether KYMRIAH and YESCARTA are
substantially similar to each other and existing technologies.
After consideration of the public comments we received, although we
recognize the technologies are not completely the same in terms of
their manufacturing process, co-stimulatory domains, and clinical
profiles, we and also as the commenters expressed, are not convinced
that these differences result in the use of a different mechanism of
action and, therefore, infer that the two technologies' mechanisms of
action are the same. Furthermore, we believe that KYMRIAH and YESCARTA
are substantially similar to one another because potential cases
representing patients who may be eligible for treatment using KYMRIAH
and YESCARTA would group to the same MS-DRGs (because the same ICD-10-
CM diagnosis codes and ICD-10-PCS procedures codes are used to report
treatment using either KYMRIAH or YESCARTA). We also believe, as we and
other commenters describe throughout this section, that these
technologies are intended to treat the same or similar disease in the
same or similar patient population--patients with r/r DLBCL who are
ineligible for, or who have failed ASCT, and are purposed to achieve
the same therapeutic outcome--ORR, CR, OS using the same or similar
mechanism of action using genetically modified autologous T-cell
immunotherapies. The respective CAR T-cells transmit a signal to
promote T-cell expansion, activation, and ultimately cancer cell
elimination to produce a targeted cellular therapy that may persist in
the body even after the malignancy is eradicated.
We also believe that KYMRIAH and YESCARTA are not substantially
similar to any other existing technologies because, as both applicants
asserted in their FY 2019 new technology add-on payment applications
and as stated by the other commenters, the technologies do not use the
same or similar mechanism of action to achieve a therapeutic outcome as
any other existing drug or therapy assigned to the same or different
MS-DRG and represent the only FDA-approved technologies for this
treatment population.
With regard to the commenter that indicated pricing of both
products varies based on the patient population, and encouraged CMS to
recognize this discrepancy when determining approval of new technology
add-on payment and establishing adequate payments rates, we note that
the applicants for both, KYMRIAH and YESCARTA, estimate that the
average cost for an administered dose of KYMRIAH or YESCARTA is
$373,000. We refer readers to the end of this discussion for complete
details on the pricing of KYMRIAH and YESCARTA.
With respect to CMS' policy for evaluating substantially similar
technologies, we believe our current policy is consistent with the
authority and criteria in section 1886(d)(5)(K) of the Act. We note
that CMS is authorized by the Act to develop criteria for the purposes
of evaluating new technology add-on payment applications. For the
purposes of new technology add-on payments, when technologies are
substantially similar to each other, we believe it is appropriate to
evaluate both technologies as one application for new technology add-on
payments under the IPPS, for the reasons we discussed above and
consistent with our evaluation of substantially similar technologies in
prior rulemaking (82 FR 38120).
Finally, we note that for FY 2019, there is no payment impact
regarding the determination that the two technologies are substantially
similar to each other because the cost of the technologies is the same.
However, we welcome additional comments in future rulemaking regarding
whether KYMRIAH and YESCARTA are substantially similar and intend to
revisit this issue in next year's proposed rule.
As we stated in the proposed rule and above, each applicant
submitted separate analysis regarding the cost criterion for each of
their products, and both applicants maintained that their product meets
the cost criterion. We summarize each analysis below.
With regard to the cost criterion, the applicant for KYMRIAH
searched the FY 2016 MedPAR claims data file to identify potential
cases representing patients who may be eligible for treatment using
KYMRIAH. The applicant identified claims that reported an ICD-10-CM
diagnosis code of: C83.30 (DLBCL, unspecified site); C83.31 (DLBCL,
lymph nodes of head, face and neck); C83.32 (DLBCL, intrathoracic lymph
nodes); C83.33 (DLBCL, intra-abdominal lymph nodes); C83.34 (DLBCL,
lymph nodes of axilla and upper limb); C83.35 (DLBCL, lymph nodes of
inquinal region and lower limb); C83.36 (DLBCL, intrapelvic lymph
nodes); C83.37 (DLBCL, spleen); C83.38 (DLBCL, lymph nodes of multiple
sites); or C83.39 (DLBCL, extranodal and solid organ sites). The
applicant also identified potential cases where patients received
chemotherapy using two encounter codes, Z51.11 (Antineoplastic
chemotherapy) and Z51.12 (Antineoplastic immunotherapy), in conjunction
with DLBCL diagnosis codes.
Applying the parameters above, the applicant for KYMRIAH identified
a total of 22,589 DLBCL potential cases that mapped to 437 MS-DRGs. The
applicant chose the top 20 MS-DRGs which made up a total of 15,451
potential cases at 68 percent of total cases. Of the 22,589 total DLBCL
potential cases, the applicant also provided a breakdown of DLBCL
potential cases where chemotherapy was used, and DLBCL potential cases
where chemotherapy was not used. Of the 6,501 DLBCL potential cases
where chemotherapy was used, MS-DRGs 846 and 847 accounted for 6,181
(95 percent) of the 6,501 cases. Of the 16,088 DLBCL potential cases
where chemotherapy was not used, the applicant chose the top 20 MS-DRGs
which made up a total of 9,333 potential cases at 58 percent of total
cases. The applicant believed the distribution of patients that may be
eligible for treatment using KYMRIAH will include a wide variety of MS-
DRGs. As such, the applicant conducted an analysis of three scenarios:
potential DLBCL cases, potential DLBCL cases with chemotherapy, and
potential DLBCL cases without chemotherapy.
The applicant removed reported historic charges that would be
avoided through the use of KYMRIAH. Next, the applicant removed 50
percent of the chemotherapy pharmacy charges that would not be required
for patients that may be eligible to receive treatment using KYMRIAH.
The applicant standardized the charges and then applied an inflation
factor of 1.09357, which is the 2-year inflation factor in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38527), to update the charges from FY
2016 to FY 2018. The applicant did not add charges for KYMRIAH to its
analysis. However, the applicant provided a cost analysis related to
the three categories of claims data it previously researched (that is,
potential DLBCL cases, potential DLBCL cases with chemotherapy, and
potential DLBCL cases without chemotherapy). The applicant's analysis
showed the inflated average case-weighted standardized charge per case
for
[[Page 41292]]
potential DLBCL cases, potential DLBCL cases with chemotherapy, and
potential DLBCL cases without chemotherapy was $63,271, $39,723, and
$72,781, respectively. The average case-weighted threshold amount for
potential DLBCL cases, potential DLBCL cases with chemotherapy, and
potential DLBCL cases without chemotherapy was $58,278, $48,190, and
$62,355 respectively. While the inflated average case-weighted
standardized charge per case ($39,723) is lower than the average case-
weighted threshold amount ($48,190) for potential DLBCL cases with
chemotherapy, the applicant expected the cost of KYMRIAH to be higher
than the new technology add-on payment threshold amount for all three
cohorts. Therefore, the applicant maintained that it met the cost
criterion.
We noted in the proposed rule that, as discussed in section
II.F.2.d. of the preamble of the proposed rule, we proposed to assign
the ICD-10-PCS procedure codes that describe procedures involving the
utilization of these CAR T-cell therapy drugs and cases representing
patients receiving treatment involving CAR T-cell therapy procedures to
Pre-MDC MS-DRG 016 for FY 2019. Therefore, in addition to the analysis
above, we compared the inflated average case-weighted standardized
charge per case from all three cohorts above to the average case-
weighted threshold amount for MS-DRG 016. The average case-weighted
threshold amount for MS-DRG 016 from Table 10 in the FY 2018 IPPS/LTCH
PPS final rule is $161,058. Although the inflated average case-weighted
standardized charge per case for all three cohorts ($63,271, $39,723,
and $72,781) is lower than the average case-weighted threshold amount
for MS-DRG 016, we noted that similar to above, the applicant expected
the cost of KYMRIAH to be higher than the new technology add-on payment
threshold amount for MS-DRG 016. Therefore, it appeared that KYMRIAH
would meet the cost criterion under this scenario as well.
We stated in the proposed rule that we appreciated the applicant's
analysis. However, we noted that the applicant did not provide
information regarding which specific historic charges were removed in
conducting its cost analysis. Nonetheless, we stated that we believed
that even if historic charges were identified and removed, the
applicant would meet the cost criterion because, as indicated, the
applicant expected the cost of KYMRIAH to be higher than the new
technology add-on payment threshold amounts listed earlier.
We invited public comments on whether KYMRIAH meets the cost
criterion.
Comment: Commenters agreed with CMS that KYMRIAH meets the cost
criterion for new technology add-on payments based on the analysis
above. The commenters noted that more recent information indicates that
the cost of the drug alone is more than twice the estimated new
technology add-on payment MS-DRG threshold amount.
Response: We appreciate the commenters' input and note that, since
the publication of the proposed rule, CMS has received supplemental
information that the cost for each administration of KYMRIAH is
$373,000.
After consideration of the public comments we received, we agree
that KYMRIAH meets the cost criterion.
With regard to the cost criterion in reference to YESCARTA, the
applicant conducted the following analysis. The applicant examined FY
2016 MedPAR claims data restricted to patients discharged in FY 2016.
The applicant included potential cases reporting an ICD-10 diagnosis
code of C83.38. Noting that only MS-DRGs 820 (Lymphoma and Leukemia
with Major O.R. Procedure with MCC), 821 (Lymphoma and Leukemia with
Major O.R. Procedure with CC), 823 and 824 (Lymphoma and Non-Acute
Leukemia with Other O.R. Procedure with MCC, with CC, respectively),
825 (Lymphoma and Non Acute Leukemia with Other O.R Procedure without
CC/MCC), and 840, 841 and 842 (Lymphoma and Non-Acute Leukemia with
MCC, with CC and without CC/MCC, respectively) consisted of 10 or more
cases, the applicant limited its analysis to these 8 MS-DRGs. The
applicant identified 827 potential cases across these MS-DRGs. The
average case-weighted unstandardized charge per case was $126,978. The
applicant standardized charges using FY 2016 standardization factors
and applied an inflation factor of 1.09357 from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38527). The applicant for YESCARTA did not
include the cost of its technology in its analysis.
Included in the average case-weighted standardized charge per case
were charges for the current treatment components. Therefore, the
applicant for YESCARTA removed 20 percent of radiology charges to
account for chemotherapy, and calculated the adjusted average case-
weighted standardized charge per case by subtracting these charges from
the standardized charge per case. Based on the distribution of
potential cases within the eight MS-DRGs, the applicant case-weighted
the final inflated average case-weighted standardized charge per case.
This resulted in an inflated average case-weighted standardized charge
per case of $118,575. Using the FY 2018 IPPS Table 10 thresholds, the
average case-weighted threshold amount was $72,858. Even without
considering the cost of its technology, the applicant maintained that
because the inflated average case-weighted standardized charge per case
exceeded the average case-weighted threshold amount, the technology met
the cost criterion.
We noted in the proposed rule that, as discussed in section
II.F.2.d. of the preamble of the proposed rule, we proposed to assign
the ICD-10-PCS procedure codes that describe procedures involving the
utilization of these CAR T-cell therapy drugs and cases representing
patients receiving treatment involving CAR T-cell therapy procedures to
Pre-MDC MS-DRG 016 for FY 2019. Therefore, in addition to the analysis
above, we compared the inflated average case-weighted standardized
charge per case ($118,575) to the average case-weighted threshold
amount for MS-DRG 016. The average case-weighted threshold amount for
MS-DRG 016 from Table 10 in the FY 2018 IPPS/LTCH PPS final rule is
$161,058. Although the inflated average case-weighted standardized
charge per case is lower than the average case-weighted threshold
amount for MS-DRG 016, we noted that the applicant expected the cost of
YESCARTA to be higher than the new technology add-on payment threshold
amount for MS-DRG 016. Therefore, we stated that it appeared that
YESCARTA would meet the cost criterion under this scenario as well.
We invited public comments on whether YESCARTA technology meets the
cost criterion.
Comment: Commenters agreed with CMS that YESCARTA meets the cost
criterion for new technology add-on payments based on the analysis
above. The commenters noted that more recent information indicates the
cost of the drug alone is more than twice the estimated new technology
add-on payment MS-DRG threshold amount.
Response: We appreciate the commenters' input and note that, since
the publication of the proposed rule, CMS has received supplemental
information that the cost for each administration of YESCARTA is
$373,000.
After consideration of the public comments we received, we agree
that YESCARTA meets the cost criterion.
[[Page 41293]]
With regard to substantial clinical improvement for KYMRIAH, the
applicant asserted that several aspects of the treatment represent a
substantial clinical improvement over existing technologies. The
applicant believed that KYMRIAH allows access for a treatment option
for those patients who are unable to receive standard-of-care
treatment. The applicant stated in its application that there are no
currently FDA-approved treatment options for patients with r/r DLBCL
who are ineligible for or who have failed ASCT. Additionally, the
applicant maintained that KYMRIAH significantly improves clinical
outcomes, including ORR, CR, OS, and durability of response, and allows
for a manageable safety profile. The applicant asserted that, when
compared to the historical control data (SCHOLAR-1) and the currently
available treatment options, it is clear that KYMRIAH significantly
improves clinical outcomes for patients with r/r DLBCL who are not
eligible for ASCT. The applicant conveyed that, given that the patient
population has no other available treatment options and an expected
very short lifespan without therapy, there are no randomized controlled
trials of the use of KYMRIAH in patients with r/r DLBCL and, therefore,
efficacy assessments must be made in comparison to historical control
data. The SCHOLAR-1 study is the most comprehensive evaluation of the
outcome of patients with refractory DLBCL. SCHOLAR-1 includes patients
from two large randomized controlled trials (Lymphoma Academic Research
Organization-CORAL and Canadian Cancer Trials Group LY.12) and two
clinical databases (MD Anderson Cancer Center and University of Iowa/
Mayo Clinic Lymphoma Specialized Program of Research Excellence).\35\
---------------------------------------------------------------------------
\35\ Crump, M., Neelapu, S.S., Farooq, U., et al., ``Outcomes in
refractory diffuse large B-cell lymphoma: Results from the
international SCHOLAR-1 study,'' Blood, Published online: August 3,
2017, doi: 10.1182/blood-2017-03-769620.
---------------------------------------------------------------------------
The applicant for KYMRIAH conveyed that the PARMA study established
high-dose chemotherapy and ASCT as the standard treatment for patients
with r/r DLBCL.\36\ However, according to the applicant, many patients
with r/r DLBCL are ineligible for ASCT because of medical frailty.
Patients who are ineligible for ASCT because of medical frailty would
also be adversely affected by high-dose chemotherapy regimens.\37\
Lowering the toxicity of chemotherapy regimens becomes the only
treatment option, leaving patients with little potential for
therapeutic outcomes. According to the applicant, the lack of efficacy
of these aforementioned salvage regimens was demonstrated in nine
studies evaluating combined chemotherapeutic regimens in patients who
were either refractory to first-line or first salvage. Chemotherapy
response rates ranged from 0 percent to 23 percent with OS less than 10
months in all studies.\38\ For patients who do not respond to combined
therapy regimens, the National Comprehensive Cancer Network (NCCN)
offers only clinical trials or palliative care as therapeutic
options.\39\
---------------------------------------------------------------------------
\36\ Philip, T., Guglielmi, C., Hagenbeek, A., et al.,
``Autologous bone marrow transplantation as compared with salvage
chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's
lymphoma,'' N Engl J Med, 1995, vol. 333(23), pp. 1540-1545.
\37\ Friedberg, J.W., ``Relapsed/refractory diffuse large B-cell
lymphoma,'' Hematology AM Soc Hematol Educ Program, 2011, vol. (1),
pp. 498-505.
\38\ Crump, M., Neelapu, S.S., Farooq, U., et al., ``Outcomes in
refractory diffuse large B-cell lymphoma: Results from the
international SCHOLAR-1 study,'' Blood, Published online: August 3,
2017, doi: 10.1182/blood-2017-03-769620.
\39\ National Comprehensive Cancer Network, NCCN Clinical
Practice Guidelines in Oncology (NCCN GuidelinesR), ``B-cell
lymphomas: Diffuse large b-cell lymphoma and follicular lymphoma
(Version 3.2017),'' May 25, 2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell_blocks.pdf.
---------------------------------------------------------------------------
According to the applicant for KYMRIAH, the immunomodulatory agent
Lenalidomide was only able to show an ORR of 30 percent, a CR rate of 8
percent, and a 4.6-month median duration of response.\40\ M-tor
inhibitors such as Everolimus and Temserolimus have been studied as
single agents, or in combination with Rituximab, as have newer
monoclonal antibodies Dacetuzumab, Ofatumomab and Obinutuzumab.
However, none induced a CR rate higher than 20 percent or showed a
median duration of response longer than 1 year.\41\
---------------------------------------------------------------------------
\40\ Klyuchnikov, E., Bacher, U., Kroll, T., et al.,
``Allogeneic hematopoietic cell transplantation for diffuse large B
cell lymphoma: Who, when and how?,'' Bone Marrow Transplant, 2014,
vol. 49(1), pp. 1-7.
\41\ Ibid.
---------------------------------------------------------------------------
According to the applicant, although controversial, allogeneic stem
cell transplantation (allo-SCT) has been proposed for patients who have
been diagnosed with r/r disease. It is hypothesized that the malignant
cell will be less able to escape the immune targeting of allogenic T-
cells--known as the graft-vs-lymphoma effect.42 43 The use
of allo-SCT is limited in patients who are not eligible for ASCT
because of the high rate of morbidity and mortality. This medically
frail population is generally excluded from participation. The
population most impacted by this is the elderly, who are often excluded
based on age alone. In seven studies evaluating allo-SCT in patients
with r/r DLBCL, the median age at transplant was 43 years old to 52
years old, considerably lower than the median age of patients with
DLBCL of 64 years old. Only two studies included any patients over 66
years old. In these studies, allo-SCT provided OS rates ranging from 18
percent to 52 percent at 3 to 5 years, but was accompanied by
treatment-related mortality rates ranging from 23 percent to 56
percent.\44\ According to the applicant, this toxicity and efficacy
profile of allo-SCT substantially limits its use, especially in
patients 65 years old and older. Given the high unmet medical need, the
applicant maintained that KYMRIAH represents a substantial clinical
improvement by offering a treatment option for a patient population
unresponsive to, or ineligible for, currently available treatments.
---------------------------------------------------------------------------
\42\ Ibid.
\43\ Maude, S.L., Teachey, D.T., Porter, D.L., Grupp, S.A.,
``CD19-targeted chimeric antigen receptor T-cell therapy for acute
lymphoblastic leukemia,'' Blood, 2015, vol. 125(26), pp. 4017-4023.
\44\ Klyuchnikov, E., Bacher, U., Kroll, T., et al.,
``Allogeneic hematopoietic cell transplantation for diffuse large B
cell lymphoma: Who, when and how?,'' Bone Marrow Transplant, 2014,
vol. 49(1), pp. 1-7.
---------------------------------------------------------------------------
To express how KYMRIAH has improved clinical outcomes, including
ORR, CR rate, OS, and durability of response, the applicant referenced
clinical trials in which KYMRIAH was tested. Study 1 was a single-arm,
open-label, multi-site, global Phase II study to determine the safety
and efficacy of tisagenlecleucel in patients with R/R DLBCL
(CCTL019C2201/CT02445248/`JULIET' study).45 46 47 Key
inclusion criteria included patients who were 18 years old and older,
patients with refractory to at least two lines of chemotherapy and
either relapsed post ASCT or who were ineligible for ASCT, measurable
disease at the time of infusion, and adequate organ and bone marrow
function. The study was conducted in three phases. In the screening
phase patient eligibility was
[[Page 41294]]
assessed and patient cells collected for product manufacture. Patients
were also able to receive bridging, cytotoxic chemotherapy during this
time. In the pre-treatment phase patients underwent a restaging of
disease followed by lymphodepleting chemotherapy with fludarabine 25mg/
m2 x 3 and cyclophosphamide 250mg/m2/d x 3 or bendamustine 90mg/m2/d x
2 days. The treatment and follow-up phase began 2 to 14 days after
lymphodepleting chemotherapy, when the patient received a single
infusion of tisagenlecleucel with a target dose of 5 x 108
CTL019 transduced viable cells. The primary objective was to assess the
efficacy of tisagenlecleucel, as measured by the best overall response
(BOR), which was defined as CR or partial response (PR). It was
assessed on the Chesson 2007 response criteria amended by Novartis
Pharmaceutical Corporation as confirmed by an Independent Review
Committee (IRC). One hundred forty-seven patients were enrolled, and 99
of them were infused with tisagenlecleucel. Forty-three patients
discontinued prior to infusion (9 due to inability to manufacture and
34 due to patient-related issues).\48\ The median age of treated
patients was 56 years old with a range of 24 to 75; 20 percent were
older than 65 years old. Patients had received 2 to 7 prior lines of
therapy, with 60 percent receiving 3 or more therapies, and 51 percent
having previously undergone ASCT. A primary analysis was performed on
81 patients infused and followed for more than or at least 3 months. In
this primary analysis, the BOR was 53 percent; the study met its
primary objective based on statistical analysis (that is, testing
whether BOR was greater than 20 percent, a clinically relevant
threshold chosen based on the response to chemotherapy in a patient
with r/r DLBCL). Forty-three percent (43 percent) of evaluated patients
reached a CR, and 14 percent reached a PR. ORR evaluated at 3 months
was 38 percent with a distribution of 32 percent CR and 6 percent PR.
All patients in CR at 3 months continued to be in CR. ORR was similar
across subgroups including 64.7 percent response in patients who were
older than 65 years old, 61.1 percent response in patients with Grade
III/IV disease at the time of enrollment, 58.3 percent response in
patients with Activated B-cell, 52.4 percent response in patients with
Germinal Center B-cell subtype, and 60 percent response in patients
with double and triple hit lymphoma. Durability of response was
assessed based on relapse free survival (RFS), which was estimated at
74 percent at 6 months.
---------------------------------------------------------------------------
\45\ Data on file, Oncology clinical trial protocol
CCTL019C2201: ``A Phase II, single-arm, multi-center trial to
determine the efficacy and safety of CTL019 in adult patients with
relapsed or refractory diffuse large Bcell lymphoma (DLBCL),''
Novartis Pharmaceutical Corp, 2015.
\46\ Schuster, S.J., Bishop, M.R., Tam, C., et al., ``Global
trial of the efficacy and safety of CTL019 in adult patients with
relapsed or refractory diffuse large B-cell lymphoma: An interim
analysis,'' Presented at: 22nd Congress of the European Hematology
Association, June 22-25, 2017, Madrid, Spain.
\47\ ClinicalTrials.gov, ``Study of efficacy and safety of
CTL019 in adult DLBCL patients (JULIET).''Available at: https://clinicaltrials.gov/ct2/show/NCT02445248.
\48\ Schuster, S.J., Bishop, M.R., Tam, C., et al., ``Global
trial of the efficacy and safety of CTL019 in adult patients with
relapsed or refractory diffuse large B-cell lymphoma: an interim
analysis,'' Presented at: 22nd Congress of the European Hematology
Association, June 22-25, 2017, Madrid, Spain.
---------------------------------------------------------------------------
The applicant for KYMRIAH reported that Study 2 was a supportive
Phase IIa single institution study of adults who were diagnosed with
advanced CD19+ NHL conducted at the University of
Pennsylvania.49 50 Tisagenlecleucel cells were produced at
the University of Pennsylvania using the same genetic construct and a
similar manufacturing technique as employed in Study 1. Key inclusion
criteria included patients who were at least 18 years old, patients
with CD19+ lymphoma with no available curative options, and measurable
disease at the time of enrollment. Tisagenlecleucel was delivered in a
single infusion 1 to 4 days after restaging and lymphodepleting
chemotherapy. The median tisagenlecleucel cell dose was 5.0 x 108
transduced cells. The study enrolled 38 patients; of these, 21 were
diagnosed with DLBCL and 13 received treatment involving KYMRIAH.
Patients ranged in age from 25 to 77 years old, and had a median of 4
prior therapies. Thirty-seven percent had undergone ASCT and 63 percent
were diagnosed with Grade III/IV disease. ORR at 3 months was 54
percent. Progression free survival was 43 percent at a median follow-up
of 11.7 months. Safety and efficacy results are similar to those of the
multi-center study.
---------------------------------------------------------------------------
\49\ ClinicalTrials.gov, ``Phase IIa study of redirected
autologous T-cells engineered to contain anti-CD19 attached to TCRz
and 4-signaling domains in patients with chemotherapy relapsed or
refractory CD19+ lymphomas,'' Available at: https://clinicaltrials.gov/ct2/show/NCT02030834.
\50\ Schuster, S.J., Svoboda, J., Nasta, S.D., et al.,
``Sustained remissions following chimeric antigen receptor modified
T-cells directed against CD-19 (CTL019) in patients with relapsed or
refractory CD19+ lymphomas,'' Presented at: 57th Annual Meeting of
the American Society of Hematology, December 6, 2015, Orlando, FL.
---------------------------------------------------------------------------
The applicant for KYMRIAH reported that Study 3 was a supportive,
patient-level meta-analysis of historical outcomes in patients who were
diagnosed with refractory DLBCL (SCHOLAR-1).\51\ This study included a
pooled data analysis of two Phase III clinical trials (Lymphoma
Academic Research Organization-CORAL and Canadian Cancer Trials Group
LY.12) and two observational cohorts (MD Anderson Cancer Center and
University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research
Excellence). Refractory disease was defined as progressive disease or
stable disease as best response to chemotherapy (received more than or
at least 4 cycles of first-line therapy or 2 cycles of later-line
therapy, respectively) or relapse in less than or at 12 months post-
ASCT. Of 861 abstracted records, 636 were included based on these
criteria. All patients from each data source who met criteria for
diagnosis of refractory DLBCL, including TFL and PMBCL, who went on to
receive subsequent therapy were considered for analysis. Patients who
were diagnosed with TFL and PMBCL were included because they are
histologically similar and clinically treated as large cell lymphoma.
Response rates were similar across the 4 datasets, ranging from 20
percent to 31 percent, with a pooled response rate of 26 percent. CR
rates ranged from 2 percent to 15 percent, with a pooled CR rate of 7
percent. Subgroup analyses including patients with primary refractory,
refractory to second or later-line therapy, and relapse in less than 12
months post-ASCT revealed response rates similar to the pooled
analysis, with worst outcomes in the primary refractory group (20
percent). OS from the commencement of therapy was 6.3 months and was
similar across subgroup analyses. Achieving a CR after last salvage
chemotherapy predicted a longer OS of 14.9 months compared to 4.6
months in nonresponders. Patients who had not undergone ASCT had an OS
of 5.1 months with a 2 year OS rate of 11 percent.
---------------------------------------------------------------------------
\51\ Crump, M., Neelapu, S.S., Farooq, U., et al., ``Outcomes in
refractory diffuse large B-cell lymphoma: Results from the
international SCHOLAR-1 study,'' Blood, Published online: August 3,
2017, doi: 10.1182/blood-2017-03-769620.
---------------------------------------------------------------------------
The applicant asserted that KYMRIAH provides a manageable safety
profile when treatment is performed by trained medical personnel and,
as opposed to ASCT, KYMRIAH mitigates the need for high-dose
chemotherapy to induce response prior to infusion. Adverse events were
most common in the 8 weeks following infusion and were manageable by a
trained staff. Cytokine Relapse Syndrome (CRS) occurred in 58 percent
of patients with 23 percent having Grade III or IV events as graded on
the University of Pennsylvania grading system.52 53 Median
time to
[[Page 41295]]
onset of CRS was 3 days and median duration was 7 days with a range of
2 to 30 days. Twenty-four percent of the patients required ICU
admission. CRS was managed with supportive care in most patients.
However, 16 percent required anti-cytokine therapy including
tocilizumab (15 percent) and corticosteroids (11 percent). Other
adverse events of special interest include infection in 34 percent (20
percent Grade III or IV) of patients, cytopenias not resolved by day 28
in 36 percent (27 percent Grade III or IV) of patients, neurologic
events in 21 percent (12 percent Grade III or IV) of patients, febrile
neutropenia in 13 percent (13 percent Grade III or IV) of patients, and
tumor lysis syndrome 1 percent (1 percent Grade III). No deaths were
attributed to tisagenlecleucel including no fatal cases of CRS or
neurologic events. No cerebral edema was observed.\54\ Study 2 safety
results were consistent to those of Study 1.\55\
---------------------------------------------------------------------------
\52\ ClinicalTrials.gov, ``Phase IIa study of redirected
autologous T-cells engineered to contain anti-CD19 attached to TCRz
and 4-signaling domains in patients with chemotherapy relapsed or
refractory CD19+ lymphomas.'' Available at: https://clinicaltrials.gov/ct2/show/NCT02030834.
\53\ Schuster, S.J., Svoboda, J., Nasta, S.D., et al.,
``Sustained remissions following chimeric antigen receptor modified
T-cells directed against CD-19 (CTL019) in patients with relapsed or
refractory CD19+ lymphomas,'' Presented at: 57th Annual Meeting of
the American Society of Hematology, December 6, 2015, Orlando, FL.
\54\ Schuster, S.J., Bishop, M.R., Tam, C., et al., ``Global
trial of the efficacy and safety of CTL019 in adult patients with
relapsed or refractory diffuse large B-cell lymphoma: an interim
analysis,'' Presented at: 22nd Congress of the European Hematology
Association, June 22-25, 2017, Madrid, Spain.
\55\ Ibid.
---------------------------------------------------------------------------
After reviewing the studies provided by the applicant, in the FY
2019 IPPS/LTCH PPS proposed rule (83 FR 20292), we stated that we were
concerned the applicant included patients who were diagnosed with TFL
and PMBCL in the SCHOLAR-1 data results for their comparison analysis,
possibly skewing results. Furthermore, the discontinue rate of the
JULIET trial was high. Of 147 patients enrolled for infusion involving
KYMRIAH, 43 discontinued prior to infusion (9 discontinued due to
inability to manufacture, and 34 discontinued due to patient-related
issues). Finally, the rate of patients who experienced a diagnosis of
CRS was high, 58 percent.\56\
---------------------------------------------------------------------------
\56\ Schuster, S.J., Bishop, M.R., Tam, C., et al., ``Global
trial of the efficacy and safety of CTL019 in adult patients with
relapsed or refractory diffuse large B-cell lymphoma: an interim
analysis,'' Presented at: 22nd Congress of the European Hematology
Association, June 22-25, 2017, Madrid, Spain.
---------------------------------------------------------------------------
The applicant for YESCARTA stated that YESCARTA represents a
substantial clinical improvement over existing technologies when used
in the treatment of patients with aggressive B-cell NHL. The applicant
asserted that YESCARTA can benefit the patient population with the
highest unmet need, patients with r/r disease after failure of first-
line or second-line therapy, and patients who have failed or who are
ineligible for ASCT. These patients, otherwise, have adverse outcomes
as demonstrated by historical control data.
Regarding clinical data for YESCARTA, the applicant stated that
historical control data was the only ethical and feasible comparison
information for these patients with chemorefractory, aggressive NHL who
have no other available treatment options and who are expected to have
a very short lifespan without therapy. According to the applicant,
based on meta-analysis of outcomes in patients with chemorefractory
DLBCL, there are no curative options for patients with aggressive B-
cell NHL, regardless of refractory subgroup, line of therapy, and
disease stage with their median OS being 6.6 months.\57\
---------------------------------------------------------------------------
\57\ Seshardi, T., et al., ``Salvage therapy for relapsed/
refractory diffuse large B-cell lymphoma,'' Biol Blood Marrow
Transplant, 2008 Mar, vol. 14(3), pp. 259-67.
---------------------------------------------------------------------------
In the applicant's FY 2018 new technology add-on payment
application for the KTE-C19 technology, which was discussed in the FY
2018 IPPS/LTCH PPS proposed rule (82 FR 19889), the applicant cited
ongoing clinical trials. The applicant provided updated data related to
these ongoing clinical trials as part of its FY 2019 application for
YESCARTA.58 59 60 The updated analysis of the pivotal Study
1 (ZUMA-1, KTE-C19-101), Phase I and II occurred when patients had been
followed for 12 months after infusion of YESCARTA. Study 1 is a Phase
I-II multi-center, open-label study evaluating the safety and efficacy
of the use of YESCARTA in patients with aggressive refractory NHL. The
trial consists of two distinct phases designed as Phase I (n=7) and
Phase II (n=101). Phase II is a multi-cohort open-label study
evaluating the efficacy of YESCARTA.\61\ The applicant noted that, as
of the analysis cutoff date for the interim analysis, the results of
Study 1 demonstrated rapid and substantial improvement in objective, or
ORR. After 6 and 12 months, the ORR was 82 and 83 percent,
respectively. Consistent response rates were observed in both Study 1,
Cohort 1 (DLBCL; n=77) and Cohort 2 (PMBCL or TFL; n=24) and across
covariates including disease stage, age, IPI scores, CD-19 status, and
refractory disease subset. In the updated analysis, results were
consistent across age groups. In this analysis, 39 percent of patients
younger than 65 years old were in ongoing response, and 50 percent of
patients at least 65 years old or older were in ongoing response.
Similarly, the survival rate at 12 months was 57 percent among patients
younger than 65 years old and 71 percent among patients at least 65
years old or older versus historical control of 26 percent. The
applicant further stated that evidence of substantial clinical
improvement regarding the efficacy of YESCARTA for the treatment of
patients with chemorefractory, aggressive B-cell NHL is supported by
the CR of YESCARTA in Study 1, Phase II (54 percent) versus the
historical control (7 percent).62 63 64 65 The applicant
noted that CR rates were observed in both Study 1, Cohort 1. The
applicant reported that, in the updated analysis, results were in
ongoing response (46 percent of patients at least 65 years old or older
were in ongoing response). Similarly, the survival rate at 12 months
was 57 percent among patients younger than 65 years old and 71 percent
among patients at least 65 years old or older.66 67 68 69
The applicant also
[[Page 41296]]
provided the following tables to depict data to support substantial
clinical improvement (we refer readers to the two tables below).
---------------------------------------------------------------------------
\58\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
1 of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\59\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (axi-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
\60\ Locke, F.L., et al., ``Phase I results of ZUMA-1: a
multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in
refractory aggressive lymphoma,'' Mol Ther, vol. 25, No 1, January
2017.
\61\ Neelapu, S.S., Locke, F.L., et al., 2016, ``KTE-C19 (anti-
CD19 CAR T cells) induces complete remissions in patients with
refractory diffuse large B-cell lymphoma (DLBCL): results from the
pivotal Phase II ZUMA-1,'' Abstract presented at American Society of
Hematology (ASH) 58th Annual Meeting, December 2016.
\62\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
I of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\63\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (axi-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
\64\ Locke, F.L., et al., ``Phase I results of ZUMA-1: a
multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in
refractory aggressive lymphoma,'' Mol Ther, vol. 25, No 1, January
2017.
\65\ Crump, et al., 2017, ``Outcomes in refractory diffuse large
B-cell lymphoma: Results from the international SCHOLAR-1 study,''
Blood, vol. 0, 2017, pp. blood-2017-03-769620v1.
\66\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
I of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\67\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (axi-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
\68\ Locke, F.L., et al., ``Phase I results of ZUMA-1: a
multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in
refractory aggressive lymphoma,'' Mol Ther, vol. 25, No 1, January
2017.
\69\ Crump, et al., ``Outcomes in refractory diffuse large B-
cell lymphoma: results from the international SCHOLAR-1 study,''
Blood, vol. 0, 2017, pp. blood-2017-03-769620v1.
Overall Response Rates Across All YESCARTA Studies vs. SCHOLAR-1
----------------------------------------------------------------------------------------------------------------
Study 1, Phase Scholar-1
I n=7 Study 1, Phase II n=101 n=529
----------------------------------------------------------------------------------------------------------------
Overall Response Rate (%)............. 71 83...................................... 26
Month 6 (%)........................... 43 41......................................
Ongoing with >15 Months of follow-up 43 42......................................
(%).
Ongoing with >18 Months of follow-up 43 Follow-up ongoing.......................
(%).
----------------------------------------------------------------------------------------------------------------
Results for YESCARTA Study 1, Phase II: Complete Response
------------------------------------------------------------------------
Study 1, Phase II n=101
------------------------------------------------------------------------
Complete Response (%) (95 Percent 54 (44,64).
Confidence Interval).
Duration of Response, median (range in not reached.
months).
Ongoing Responses, CR (%) Median 8.7 39.
months follow-up; median overall survival
has not been reached.
Ongoing Responses, CR (%) Median 15.3 40.
months follow-up; median overall survival
has not been reached.
------------------------------------------------------------------------
According to the applicant, the 6-month and 12-month survival rates
(95 percent CI) for patients enrolled in the SCHOLAR-1 study were 53
percent (49 percent, 57 percent) and 28 percent (25 percent, 32
percent).\70\ In contrast, the 6-month and 12-month survival rates (95
percent CI) in the Study 1 updated analysis were 79 percent (70
percent, 86 percent) and 60 percent (50 percent, 69
percent).71 72 73
---------------------------------------------------------------------------
\70\ Crump, et al., ``Outcomes in refractory diffuse large B-
cell lymphoma: results from the international SCHOLAR-1 study,''
Blood, vol. 0, 2017, pp. blood-2017-03-769620v1.
\71\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
I of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\72\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (axi-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
\73\ Locke, F.L., et al., ``Phase I results of ZUMA-1: a
multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in
refractory aggressive lymphoma,'' Mol Ther, vol. 25, No 1, January
2017.
---------------------------------------------------------------------------
The applicant also cited safety results from the pivotal Study 1,
Phase II. According to the applicant, the clinical trial protocol
stipulated that patients were infused with YESCARTA in the hospital
inpatient setting and were monitored in the inpatient setting for at
least 7 days for early identification and treatment involving YESCARTA-
related toxicities, which primarily included CRS diagnoses and
neurotoxicities. The applicant noted that the interim analysis showed
the length of stay following infusion of YESCARTA was a median of 15
days. Ninety-three percent of patients experienced CRS diagnoses, 13
percent of whom experienced Grade III or higher (severe, life
threatening or fatal) CRS diagnoses. The median time to onset of CRS
diagnosis was 2 days (range 1 to 12 days) and the median time to
resolution was 8 days. Ninety-eight percent of patients recovered from
CRS diagnosis. Neurologic events occurred in 64 percent of patients, 28
percent of whom experienced Grade III or higher (severe or life
threatening) events. The median time to onset of neurologic events was
5 days (range 1 to 17 days). The median time to resolution was 17 days.
Nearly all patients recovered from neurologic events. The medications
most often used to treat these complications included growth factors,
blood products, anti-infectives, steroids, tocilizumab, and
vasopressors. Two patients died from YESCARTA-related adverse events
(hemophagocytic lymphohistiocytosis and cardiac arrest in the hospital
setting as a result of CRS diagnoses). According to the applicant,
there were no clinically important differences in adverse event rates
across age groups (younger than 65 years old; 65 years old or older),
including CRS diagnoses and neurotoxicity.74 75
---------------------------------------------------------------------------
\74\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
I of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\75\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (axi-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
---------------------------------------------------------------------------
The applicant for YESCARTA provided information regarding a safety
expansion cohort, Study 1 Phase II Safety Expansion Cohort 3 that was
created and carried out in 2017. According to the applicant, this
Safety Expansion Cohort investigated measures to mitigate the incidence
and/or severity of anti-CD-19 CAR T therapy and evaluated an adverse
event mitigation strategy by prophylactically using levetiracetam
(Keppra), an anticonvulsant, and tocilizumab, an IL-6 receptor
inhibitor. Of the 30 patients treated, 2 patients experienced Grade III
CRS diagnoses; 1 of the 2 patients recovered. In late April 2017, the
other patient also experienced multi-organ failure and a neurologic
event that subsequently progressed to a fatal Grade V cerebral edema
that was deemed related to YESCARTA treatment. This case of cerebral
edema was observed in a 21 year-old male with refractory, rapidly
progressive, symptomatic, stage IVB PMBCL. Analysis of the baseline
serum and cerebrospinal fluid (CSF) obtained prior to any study
treatment demonstrated high cytokine and
[[Page 41297]]
chemokine levels. According to the applicant, this suggests a
significant preexisting underlying inflammatory process, both
systemically and within the central nervous system. Rapidly progressing
disease, recent mediastinal XRT (external beam radiation therapy) and/
or CMV (cytomegalovirus) reactivation may have contributed to the pre-
existing state. There were no prior cases of cerebral edema in the 200
patients who have been treated with YESCARTA in the ZUMA clinical
development program. The single patient event from the Study 1 Phase II
Safety Expansion Cohort 3 was the first Grade V cerebral edema
event.76 77
---------------------------------------------------------------------------
\76\ Locke, F.L., et al., ``Ongoing complete remissions in Phase
I of ZUMA-1: a phase I-II multicenter study evaluating the safety
and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with
refractory aggressive B-cell non-Hodgkin lymphoma (NHL),'' Oral
presentation (abstract 10480) presented at European Society for
Medical Oncology (ESMO), October 2016.
\77\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (aci-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
---------------------------------------------------------------------------
After reviewing the information submitted by the applicant as part
of its FY 2019 new technology add-on payment application for YESCARTA,
we stated in the FY 2019 IPPS/LTCH PPS proposed rule that we were
concerned that it does not appear to include patient mortality data
that was included as part of the applicant's FY2018 new technology add-
on payment application for the KTE-C19 technology. In that application,
as discussed in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 19890),
the applicant provided that by an earlier cutoff date for the interim
analysis of Study 1, among all KTE-C19 treated patients, 12 patients in
Study 1, Phase II, including 10 from Cohort 1, and 2 from Cohort 2,
died. Eight of these deaths were due to disease progression. One
patient had disease progression after receiving KTE-C19 treatment and
subsequently had ASCT. After ASCT, the patient died due to sepsis. Two
patients (3 percent) died due to KTE-C19-related adverse events (Grade
V hemophagocytic lymphohistiocytosis event and Grade V anoxic brain
injury), and one died due to an adverse event deemed unrelated to
treatment involving KTE-C19 (Grade V pulmonary embolism), without
disease progression. We believed it would be relevant to include this
information because it is related to the same treatment that is the
subject of the applicant's FY 2019 new technology add-on payment
application.
---------------------------------------------------------------------------
\77\ Locke, F.L., et al., ``Primary results from ZUMA-1: a
pivotal trial of axicabtagene ciloretroleucel (aci-cel; KTE-C19) in
patients with refractory aggressive non-Hodgkins lymphoma (NHL),''
Oral presentation, American Association of Cancer Research (AACR).
---------------------------------------------------------------------------
We also stated that we were concerned that there are few published
results showing any survival benefits from the use of this treatment.
In addition, we were concerned with the limited number of patients
(n=108) that were studied after infusion involving YESCARTA T-cell
immunotherapy. Finally, we indicated that we were concerned about the
data related to the percentage of patients who experienced
complications or toxicities related to YESCARTA treatment. According to
the applicant, of the patients who participated in YESCARTA clinical
trials, 93 percent developed CRS diagnoses and 64 percent experienced
neurological adverse events.
We invited public comments on whether KYMRIAH and YESCARTA meet the
substantial clinical improvement criterion.
The applicants for KYMRIAH and YESCARTA, as well as others
submitted comments regarding whether KYMRIAH and YESCARTA met the
substantial clinical improvement criterion.
Comment: The applicant for KYMRIAH responded to CMS' concerns
presented in the proposed rule regarding the JULIET trial and provided
updated trial results. According to the applicant, of the 160 patients
enrolled in the JULIET trial, 106 patients received treatment involving
tisagenlecleucel, including 92 patients who received the product
manufactured in the U.S. and were followed for at least 3 months or
discontinued earlier. The applicant stated that 11 out of 160 patients
(7 percent) enrolled did not receive treatment involving
tisagenlecleucel due to manufacturing failure and 38 other patients did
not receive treatment involving tisagenlecleucel due to patient-related
issues.
In response to CMS' concerns that the use of the SCHOLAR-1 study as
a baseline for comparison to the JULIET trial may have skewed results
because the baseline population of the SCHOLAR-1 study included patient
populations diagnosed with TFL and PMBCL, the applicant for KYMRIAH
stated that the JULIET trial included patients diagnosed with TFL,
making this patient population similar in nature to what was included
in the SCHOLAR study. The applicant also indicated that, although it is
true that patients diagnosed with PMBCL were excluded from the JULIET
trial, these patients only make up 2 percent of the total population of
the 636 patients evaluated in the SCHOLAR-1 study; limiting the impact
that these patients could have had on the observed response rates. The
applicant further explained that PMBCL is a form of large cell
lymphoma, which differs from DLBCL in that the patient population is
often younger and healthier and patients diagnosed with PMBCL are more
likely to respond to first-line therapy, therefore, relapsed and
refractory (r/r) patients are rare compared to those diagnosed with
DLBCL. The applicant also stated that, due to the infrequency of
patients diagnosed with r/r PMBCL, research isolating this pathology
for treatment effect is limited. The applicant indicated that, although
some studies estimate that chemorefractory PMBCL has a lower response
rate than refractory DLBCL, those studies still report ORR equivalent
to what was shown in SCHOLAR and each of these studies' results show r/
r PMBCL patients having a CR rate that is equivalent or better than
what was observed in the larger SCHOLAR study. The applicant believed
that, given these outcomes and the small number of patients diagnosed
with PMBCL in the SCHOLAR literature, it is unlikely that the results
are skewed in such a way as to overestimate the comparative efficacy of
KYMRIAH for patients diagnosed with r/r DLBCL.
In response to CMS' concerns regarding the drop-out rate within the
JULIET trial, the applicant for KYMRIAH stated that the JULIET trial
was designed to reflect a paradigm of patient management that the
applicant believes reflects the real-world treatment decisions of
health care providers. The applicant explained that in the JULIET
trial, any patient who was identified as a candidate for treatment
involving KYMRIAH and could undergo apheresis was enrolled in the trial
at the time of apheresis collection, then patients were allowed to
undergo bridging chemotherapy during the time that they awaited a
manufacturing slot assignment and during the manufacturing process. The
applicant indicated that this is in contrast with protocols of other
trials in which patients are not enrolled until such time as a
manufacturing slot is available because patients diagnosed with r/r
DLBCL have rapidly progressive disease and they often have disease
which is resistant or refractory to therapy and, therefore, patients
may progress during this time. The applicant further stated that the
design of the JULIET trial allowed these events to be captured, whereas
other study designs that do not
[[Page 41298]]
enroll patients until a manufacturing slot is available and assigned
would not capture such events because such patients would never be
enrolled in the study. The applicant explained that the median time
from apheresis to infusion of 113 days is not a direct measure of
manufacturing time and reflects the fact that cryopreserved apheresis
allowed patients to be apheresed before trial enrollment. Additionally,
the applicant stated that the point at which the patient is infused
after manufacturing is at the discretion of the treating physician,
based on what is appropriate for the patient. The applicant explained
that the use of cryopreserved apheresis material allows physicians to
maximize the timing of apheresis for the benefit of patients and to
minimize the effect of preceding chemotherapy on the health of the
cells, which is not accounted for in a measurement of apheresis to
infusion. The applicant further stated that the clinical trial was
managed differently than their commercial process. The applicant
indicated that, early in the JULIET trial, capacity-limited
manufacturing could have led to longer wait times compared to their
current commercial (non-trial) process, where patient cells are
manufactured on a first-in, first manufactured basis and, their target
is a 22-day manufacturing cycle from receipt of leukapheresis material,
according to Novartis's requirements, to return shipping of KYMRIAH.
The applicant also responded to CMS' concern regarding the
percentage of patients who experienced CRS in the JULIET trial. The
applicant for KYMRIAH stated that updated results show, using the
conservative University of Pennsylvania Scale, CRS occurred in 78
percent of the patients enrolled in the JULIET clinical trial. However,
only 23 percent of the patients had >=Grade III CRS and no patient had
Grade V CRS. The applicant further stated that patients with low grade
CRS may reflect symptoms such as fever, myalgia, nausea or fatigue. The
applicant noted that, in this context, the patients with >=Grade III
CRS represent those with a life-threatening condition that requires
interventions to support respiratory or circulatory function. The
applicant indicated that CRS was manageable by a trained staff
according to a specific CRS treatment algorithm and current standard-
of-care for these patients includes high-dose salvage chemotherapy
regimens, as well as myeloablative therapy prior to autologous stem
cell transplant, both of which have aggressive toxicity profiles.
However, the applicant indicated that many of the toxicities of
autologous stem cell transplant are managed without the benefit of
treatment algorithms and directed therapies which aid in the management
of CRS.
The applicant for YESCARTA responded to CMS' concern that its new
technology add-on payment application did not appear to include patient
mortality data that was included as part of the applicant's FY 2018 new
technology add-on payment application for the KTE-C19 technology. The
applicant acknowledged that the Study 1 interim analysis data included
in the FY2018 new technology add-on payment application and depicted as
CMS' concern was not explicitly detailed in the FY 2019 application,
which focused on the primary analysis, nor in Supplement 2, which
provided data from the updated analysis. The applicant confirmed that
there were no new deaths from adverse events at the time of the Study 1
primary analysis (median follow-up of 6 months) or at the time of the
updated analysis (median follow-up of 15.4 months).
The applicant also responded to CMS' concern that there are few
published results describing survival benefits from the use of
YESCARTA. The applicant indicated that information to address this
issue was submitted to CMS in a new technology add-on payment
supplemental file. The applicant indicated that this file provided data
from the updated analysis (median follow-up of 15.4 months) and
references for the published manuscripts. (We note that the information
the applicant provided with its public comment was also previously
provided to CMS in the supplemental file mentioned above). The
applicant stated that, in December 2017, the long-term follow-up of
Study 1 (ZUMA-1), Phase I (n=7), and Phase II (n=101) was published in
the New England Journal of Medicine and presented at ASH 2017. The
applicant explained that at median 15.4 months follow-up at the time of
the updated analysis data cutoff (August 11, 2017), responses were
ongoing in 42 percent of the patients where median duration of response
for complete response has not been reached and median overall survival
has not been reached. The applicant indicated that the authors
concluded these high levels of durable response confirmed that YESCARTA
is highly effective and provides substantial clinical benefit for
patients diagnosed with large B-cell lymphoma who otherwise have no
curative options. Additionally, the applicant stated that results show
(best objective response, ongoing) ORR (82 percent, 42 percent) and CR
(58 percent, 40 percent) at the time of the updated analysis (15.4
months) are significantly improved over results from SCHOLAR-1
historical control of 26 percent. The applicant stated that, based on
the evidence of improved benefits provided to patients with no other
treatment options, this study supports the finding that YESCARTA
demonstrates that it represents a substantial clinical improvement over
existing treatment options. The applicant further detailed that the
results from the updated analysis show: The median time to response was
rapid (1.0 month; range, 0.8 to 6.0) and that the median duration of
complete response has not been reached. Additionally, the applicant
explained that responses to treatment, including ongoing ones, were
consistent across key covariates, including in individuals 65 years of
age and younger and those individuals 65 years of age and older. The
applicant also indicated that the median overall survival has not been
reached. However, the applicant stated that the results of the updated
analysis show the overall survival rate at 18 months was 52 percent and
56 percent of patients enrolled in the study were alive at the time of
the updated analysis. The applicant also indicated that results show
ongoing durable remissions have been observed in patients at 24 months.
The applicant for YESCARTA also responded to CMS' concern regarding
the limited number of patients (n=108) that were studied after infusion
involving YESCARTA T-cell immunotherapy. The applicant stated that the
statistical plan for Study 1 was developed by Kite in close discussion
with FDA. The applicant explained that the design of this statistical
plan was developed so that the study size would be powered to show
statistical significance for the primary end point: ORR. The applicant
indicated that the primary analysis of Study 1, Phase II demonstrates
that the primary endpoint has been met and that key secondary endpoints
including Duration of Response and Overall Survival were also met.
Therefore, the applicant believed that the results of the clinical data
show YESCARTA has demonstrated substantial clinical improvement for
patients who previously had no curative options, no standard therapy
and a short expected survival. The applicant also explained that the
sample size (the number of patients planned) for Study 1 was determined
by the number of patients required to statistically demonstrate an
improvement in the response rate with treatment involving YESCARTA and
is
[[Page 41299]]
consistent with other single-arm oncology studies with a response rate
endpoint. The applicant indicated that Study 1 had an adequate sample
size to provide 90 percent power to statistically demonstrate an
improvement in response rate relative to the historical control rate of
20 percent, and a historical control was the only ethical and feasible
study design for these r/r large B-cell lymphoma patients who
previously had no other treatment options and have a uniformly very
poor outcome without therapy. The applicant stated that standard
protocols, when evaluating a therapy with a profound improvement in the
endpoint, usually require a smaller sample size and larger studies are
required when the improvement in the endpoint is small or difficult to
demonstrate. The applicant believed that, given the magnitude of
improved benefit from treatment with YESCARTA, the sample size of n=108
was adequate to demonstrate efficacy and the trial was adequately sized
to demonstrate a positive risk-benefit consistent with Good Clinical
Practice (GCP)17 and International Conference on Harmonization (ICH)
guidelines.
Response: We appreciate the applicants' submission of additional
information to address the concerns presented in the proposed rule.
After consideration of the public comments we received, we agree
that both, KYMRIAH and YESCARTA, represent a substantial clinical
improvement over existing technologies because the technologies allow
access for a treatment option for those patients who are unable to
receive standard-of-care treatment. Additionally, there are no other
currently FDA-approved treatment options for patients with r/r DLBCL
who are ineligible for, or who have failed ASCT. Finally, both
technologies appear to significantly improve clinical outcomes,
including ORR, CR, OS, and durability of response, and allow for a
manageable safety profile.
In summary, we have determined that KYMRIAH and YESCARTA meet all
of the criteria for approval of new technology add-on payments.
Therefore, we are approving new technology add-on payments for KYMRIAH
and YESCARTA for FY 2019. We expect that KYMRIAH will be administered
for the treatment of adult patients (18 years old and older) diagnosed
with r/r DLBCL not eligible for ASCT, and YESCARTA will be administered
for the treatment of adult patients diagnosed with r/r large B-cell
lymphoma after two or more lines of systemic therapy, including DLBCL
not otherwise specified, primary mediastinal large B-cell, high grade
B-cell lymphoma, and DLBCL arising from follicular lymphoma. Cases
involving KYMRIAH and YESCARTA that are eligible for new technology
add-on payments will be identified by ICD-10-PCS procedure codes
XW033C3 and XW043C3. The applicants for both, KYMRIAH and YESCARTA,
estimate that the average cost for an administered dose of KYMRIAH or
YESCARTA is $373,000. Under Sec. 412.88(a)(2), we limit new technology
add-on payments 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 a case involving the use of KYMRIAH or YESCARTA is $186,500 for FY
2019.
We note that on May 16, 2018, CMS opened a national coverage
determination (NCD) analysis on CAR T-cell therapy for Medicare
beneficiaries with advanced cancer. The expected national coverage
analysis completion date is May 17, 2019. For more information, we
refer reader to the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=291.
Lastly, we note that in the FY 2019 IPPS/LTCH proposed rule (83 FR
20294), we discussed possible payment alternatives and invited public
comments regarding the most appropriate mechanism to provide payment to
hospitals for new technologies such as CAR T-cell therapy drugs,
including through the use of new technology add-on payments. We also
invited public comments on how they would affect incentives to
encourage lower drug prices.
As discussed further in section II.F.2.d. of the preamble of this
final rule, building on President Trump's Blueprint to Lower Drug
Prices and Reduce Out-of-Pocket Costs, the CMS Center for Medicare and
Medicaid Innovation (Innovation Center) is soliciting public comment in
the CY 2019 OPPS/ASC proposed rule on key design considerations for
developing a potential model that would test private market strategies
and introduce competition to improve quality of care for beneficiaries,
while reducing both Medicare expenditures and beneficiaries' out-of-
pocket spending. Given the relative newness of CAR T-cell therapy, the
potential model, and our request for feedback on this model approach,
we believe that it would be premature to adopt changes to our existing
payment mechanisms, including structural changes in new technology add-
on payments. Therefore, we disagree with commenters who have requested
such changes under the IPPS for FY 2019.
b. VYXEOSTM (Cytarabine and Daunorubicin Liposome for
Injection)
Jazz Pharmaceuticals, Inc. submitted an application for new
technology add-on payments for the VYXEOSTM technology for
FY 2019. (We note that Celator Pharmaceuticals, Inc. submitted an
application for new technology add-on payments for VYXEOSTM
for FY 2018. However, Celator Pharmaceuticals did not receive FDA
approval by the July 1, 2017 deadline for applications for FY 2018.)
VYXEOSTM was approved by FDA on August 3, 2017, for the
treatment of adults with newly diagnosed therapy-related acute myeloid
leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
AML is a type of cancer in which the bone marrow makes abnormal
myeloblasts (immature bone marrow white blood cells), red blood cells,
and platelets. If left untreated, AML progresses rapidly. Normally, the
bone marrow makes blood stem cells that develop into mature blood cells
over time. Stem cells have the potential to develop into many different
cell types in the body. Stem cells can act as an internal repair
system, dividing, essentially without limit, to replenish other cells.
When a stem cell divides, each new cell has the potential to either
remain a stem cell or become a specialized cell, such as a muscle cell,
a red blood cell, or a brain cell, among others. A blood stem cell may
become a myeloid stem cell or a lymphoid stem cell. Lymphoid stem cells
become white blood cells. A myeloid stem cell becomes one of three
types of mature blood cells: (1) Red blood cells that carry oxygen and
other substances to body tissues; (2) white blood cells that fight
infection; or (3) platelets that form blood clots and help to control
bleeding. In patients diagnosed with AML, the myeloid stem cells
usually become a type of myeloblast. The myeloblasts in patients
diagnosed with AML are abnormal and do not become healthy white blood
cells. Sometimes in patients diagnosed with AML, too many stem cells
become abnormal red blood cells or platelets. These abnormal cells are
called leukemia cells or blasts.
AML is defined by the World Health Organization (WHO) as greater
than 20 percent blasts in the bone marrow or blood. AML can also be
diagnosed if the blasts are found to have a chromosome change that
occurs only in a specific type of AML diagnosis, even if the blast
percentage does not reach 20 percent. Leukemia cells can build up in
the bone
[[Page 41300]]
marrow and blood, resulting in less room for healthy white blood cells,
red blood cells, and platelets. When this occurs, infection, anemia, or
increased risk for bleeding may result. Leukemia cells can spread
outside the blood to other parts of the body, including the central
nervous system (CNS), skin, and gums.
Treatment of AML diagnoses usually consists of two phases;
remission induction and post-remission therapy. Phase one, remission
induction, is aimed at eliminating as many myeloblasts as possible. The
most common used remission induction regimens for AML diagnoses are the
``7+3'' regimens using an antineoplastic and an anthracycline.
Cytarabine and daunorubicin are two commonly used drugs for ``7+3''
remission induction therapy. Cytarabine is continuously administered
intravenously over the course of 7 days, while daunorubicin is
intermittently administered intravenously for the first 3 days. The
``7+3'' regimen typically achieves a 70 to 80 percent complete
remission (CR) rate in most patients under 60 years of age.
High rates of CR are not generally seen in older patients for a
number of reasons, such as different leukemia biology, much higher
incidence of adverse cytogenetic abnormalities, higher rate of
multidrug resistant leukemic cells, and comparatively lower patient
performance status (the standard criteria for measuring how the disease
impacts a patient's daily living abilities). Intensive induction
therapy has worse outcomes in this patient population.\78\ The
applicant asserted that many older adults diagnosed with AML have a
poor performance status \79\ at presentation and multiple medical
comorbidities that make the use of intensive induction therapy quite
difficult or contraindicated altogether. Moreover, the CR rates of
poor-risk patients diagnosed with AML are substantially higher in
patients over 60 years of age; owing to a higher proportion of
secondary AML, disease developing in the setting of a prior myeloid
disorder.\80\
---------------------------------------------------------------------------
\78\ Juliusson, G., Lazarevic, V., Horstedt, A.S., Hagberg, O.,
Hoglund, M., ``Acute myeloid leukemia in the real world: why
population-based registries are needed'', Blood, 2012 Apr 26; vol.
119(17), pp. 3890-9.
\79\ Stone, R.M., et al., (2004), ``Acute myeloid leukemia.
Hematology'', Am Soc Hematol Educ Program, 2004, pp. 98-117.
\80\ Appelbaum, F.R., Gundacker, H., Head, D.R., ``Age and acute
myeloid leukemia'', Blood 2006, vol. 107, pp. 3481-3485.
---------------------------------------------------------------------------
According to the applicant, the combination of cytarabine and an
anthracycline, either as ``7+3'' regimens or as part of a different
regimen incorporating other cytotoxic agents, may be used as so-called
``salvage'' induction therapy in the treatment of adults diagnosed with
AML who experience relapse in an attempt to achieve CR. According to
the applicant, while CR rates of success vary widely depending on
underlying disease biology and host factors, there is a lower success
rate overall in achievement of CR with ``7 +3'' regimens compared to
VYXEOSTM therapy. According to the applicant, ``7+3''
regimens produce a CR rate of approximately 50 percent in younger adult
patients who have relapsed, but were in CR for at least 1 year.\81\
---------------------------------------------------------------------------
\81\ Kantarjian, H., Rayandi, F., O'Brien, S., et al.,
``Intensive chemotherapy does not benefit most older patients (age
70 years and older) with acute myeloid leukemia,'' Blood, 2010, vol.
116(22), pp. 4422.
---------------------------------------------------------------------------
VYXEOSTM is a nano-scale liposomal formulation
containing a fixed combination of cytarabine and daunorubicin in a 5:1
molar ratio. This formulation was developed by the applicant using a
proprietary system known as CombiPlex. According to the applicant,
CombiPlex addresses several fundamental shortcomings of conventional
combination regimens, specifically the conventional ``7+3'' free drug
dosing, as well as the challenges inherent in combination drug
development, by identifying the most effective synergistic molar ratio
of the drugs being combined in vitro, and fixing this ratio in a nano-
scale drug delivery complex to maintain the optimized combination after
administration and ensuring exposure of this ratio to the tumor.
Cytarabine and daunorubicin are co-encapsulated inside the
VYXEOSTM liposome at a fixed ratiometrically, optimized 5:1
cytarabine: daunorubicin molar ratio. According to the applicant,
encapsulation maintains the synergistic ratios, reduces degradation,
and minimizes the impact of drug transporters and the effect of known
resistant mechanisms. The applicant stated that the 5:1 molar ratio has
been shown, in vitro, to maximize synergistic antitumor activity across
multiple leukemic and solid tumor cell lines, including AML, and in
animal model studies to be optimally efficacious compared to other
cytarabine: daunorubicin ratios. In addition, the applicant stated that
in clinical studies, the use of VYXEOSTM has demonstrated
consistently more efficacious results than the conventional ``7+3''
free drug dosing. VYXEOSTM is intended for intravenous
administration after reconstitution with 19 mL sterile water for
injection. VYXEOSTM is administered as a 90-minute
intravenous infusion on days 1, 3, and 5 (induction therapy), as
compared to the ``7+3'' free drug dosing, which consists of two
individual drugs administered on different days, including 7 days of
continuous infusion.
With regard to the newness criterion, as discussed earlier, if a
technology meets all three of the substantial similarity 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant asserted that VYXEOSTM does not use the same or
similar mechanism of action to achieve a therapeutic outcome as any
other drug assigned to the same or a different MS-DRG. The applicant
stated that no other AML treatment is designed, nor is able, to deliver
a fixed, ratiometrically optimized and synergistic drug:drug ratio of
5:1 cytarabine to daunorubicin, and selectively target and accumulate
at the site of malignancy, while minimizing unwanted exposure, which
the applicant based on the data results of preclinical and clinical
studies of the use of VYXEOSTM. The applicant indicated that
VYXEOSTM is a nano-scale liposomal formulation of a fixed
combination of cytarabine and daunorubicin. Further, the applicant
stated that the rationale for the development of VYXEOSTM is
based on prolonged delivery of synergistic drug ratios utilizing the
applicant's proprietary, ratiometric CombiPlex technology. According to
the applicant, conventional ``7+3'' free drug dosing has no delivery
complex, and these individual drugs are administered without regard to
their ratio dependent interaction. According to the applicant,
enzymatic inactivation and imbalanced drug efflux and transporter
expression reduce drug levels in the cell. Further, decreased
cytotoxicity leads to cell survival, emergence of drug resistant cells,
and decreased overall survival.
The applicant provided the results of clinical studies to
demonstrate that the CombiPlex technology and the ratiometric dosing of
VYXEOSTM represent a shift in anticancer agent delivery,
whereby the fixed, optimized dosing provides less drug to achieve
improved efficacy, while maintaining a favorable risk-benefit profile.
The results of this ratiometric dosing approach are in contrast to the
typical combination chemotherapy
[[Page 41301]]
development that establishes the recommended dose of one agent and then
adds subsequent drugs to the combination at increasing concentrations
until the aggregate effects of toxicity are considered to be limiting
(the ``7+3'' drug regimen). According to the applicant, this current
approach to combination chemotherapy development assumes that maximum
therapeutic activity will be achieved with maximum dose intensity for
all drugs in the combination, and ignores the possibility that more
subtle concentration-dependent drug interactions could result in
frankly synergistic outcomes.
The applicant maintained that, while VYXEOSTM contains
no novel active agents, its innovative drug delivery mechanism appears
to be a superior way to deliver the two active compounds in an effort
to optimize their efficacy in killing leukemic blasts. However, in the
FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20296), we stated that we
were concerned it is possible that VYXEOSTM may use a
similar mechanism of action compared to currently available treatment
options because both the current treatment regimen and
VYXEOSTM are used in the treatment of AML by intravenous
administration of cytarabine and daunorubicin. We specifically stated
that we were concerned that the mechanism of action of the
ratiometrically fixed liposomal formulation of VYXEOSTM is
the same or similar to that of the current intravenous administration
of cytarabine and daunorubicin.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, we stated that we believe that
potential cases representing patients who may be eligible for treatment
involving VYXEOSTM would be assigned to the same MS-DRGs as
cases representing patients who receive treatment for diagnoses of AML.
With respect to the third criterion, 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, the applicant
asserted that VYXEOSTM is indicated for use in the treatment
of patients who have been diagnosed with high-risk AML. The applicant
also asserted that VYXEOSTM is the first and only approved
fixed combination of cytarabine and daunorubicin and is designed to
uniquely control the exposure using a nano-scale drug delivery vehicle
leading to statistically significant improvements in survival in
patients who have been diagnosed with high-risk AML compared to the
conventional ``7+3'' free drug dosing. We stated in the proposed rule
that we believe that VYXEOSTM involves the treatment of the
same patient population as other AML treatment therapies.
The following unique ICD-10-PCS codes were created to describe the
administration of VYXEOSTM: XW033B3 (Introduction of
cytarabine and caunorubicin liposome antineoplastic into peripheral
vein, percutaneous approach, new technology group 3) and XW043B3
(Introduction of cytarabine and daunorubicin liposome antineoplastic
into central vein, percutaneous approach, new technology group 3).
In the FY 2019 IPPS/LTCH PPS proposed rule, we invited public
comments on whether VYXEOSTM is substantially similar to
existing technology, including whether the mechanism of action of
VYXEOSTM differs from the mechanism of action of the
currently available treatment regimen. We also invited public comments
on whether VYXEOSTM meets the newness criterion.
Comment: Several commenters supported the novel and effective
ratiometric dosing drug delivery mechanism of VYXEOSTM. The
applicant stated that preclinical and clinical evidence confirms the
differentiated mechanism of action of VYXEOSTM from other
available treatment options. The applicant also reiterated that it
believed VYXEOSTM is not substantially similar to any other
currently available drug and is highly differentiated from the
conventional ``7+3'' free drug dosing treatment regimen.
Response: We appreciate the commenters' and the applicant's input
on whether VYXEOSTM meets the newness criterion. After
consideration of the public comments we received, we believe that
VYXEOSTM has a unique mechanism of action and, therefore, is
not substantially similar to other drug therapies. We believe that the
liposomal formulation used to combine daunorubicin and cytarabine to
create VYXEOSTM is unique and distinct from other anti-
cancer agents and, therefore, we believe that VYXEOSTM meets
the newness criterion.
With regard to the cost criterion, the applicant conducted the
following analysis. The applicant used the FY 2016 MedPAR Hospital
Limited Data Set (LDS) to assess the MS-DRGs to which cases
representing potential patient hospitalizations that may be eligible
for treatment involving VYXEOSTM would most likely be
assigned. These potential cases representing patients who may be
VYXEOSTM candidates were identified if they: (1) Were
diagnosed with acute myeloid leukemia (AML); and (2) received
chemotherapy during their hospital stay. The cohort was further limited
by excluding patients who had received bone marrow transplants. The
cohort used in the analysis is referred to in this discussion as the
primary cohort.
According to the applicant, the primary cohort of cases spans 131
unique MS-DRGs, 16 of which contained more than 10 cases. The most
common MS-DRGs are MS-DRG 837, 834, 838, and 839. These 4 MS-DRGs
account for 4,457 (81 percent) of the 5,483 potential cases in the
cohort.
The case-weighted unstandardized charge per case is approximately
$185,844. The applicant then removed charges related to other
chemotherapy agents because VYXEOSTM would replace the need
for the use of current chemotherapy agents. The applicant explained
that charges for chemotherapy drugs are grouped with charges for
oncology, diagnostic radiology, therapeutic radiology, nuclear
medicine, CT scans, and other imaging services in the ``Radiology
Charge Amount.'' According to the applicant, removing 100 percent of
the ``Radiology Charge Amount'' would understate the cost of care for
treatment involving VYXEOSTM for patients who may be
eligible because treatment involving VYXEOSTM would be
unlikely to replace many of the services captured in the ``Radiology
Charge Amount'' category. The applicant found that chemotherapy charges
represent less than 20 percent of the charges associated with revenue
centers grouped into the ``Radiology Charge Amount'' and removed 20
percent of the radiology charge amount in order to capture the effect
of removing chemotherapy pharmacy charges. The applicant noted that
regardless of the type of induction chemotherapy, patients being
treated for AML have AML-related complications, such as bleeding or
infection that require supportive care drug therapy. For this reason,
it is expected that eligible patients receiving treatment involving
VYXEOSTM will continue to incur other pharmacy and IV
therapy charges for AML-related complications.
After removing the charges for the prior technology, the applicant
standardized the charges. The applicant then applied an inflation
factor of 1.09357, the value used in the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38527) to update the charges from FY 2016 to FY 2018.
According to the applicant, for the primary new technology add-on
payment cohort, the cost criterion was
[[Page 41302]]
met without consideration of VYXEOSTM charges. The average
case-weighted standardized charge was $170,458, which exceeded the
average case-weighted Table 10 MS-DRG threshold amount of $82,561 by
$87,897.
The applicant provided additional analyses with the inclusion of
VYXEOSTM charges under 3-vial, 4-vial, 6-vial, and 10-vial
treatment scenarios. According to the applicant, the cost criterion was
satisfied in each of these scenarios, with charges in excess of the
average case-weighted threshold amount.
Finally, the applicant also provided the following sensitivity
analyses (that did not include charges for VYXEOSTM) using
the methodology above:
Sensitivity Analysis 1--limited the cohort to patients who
have been diagnosed with AML without remission (C92.00 or C92.50) who
received chemotherapy and did not receive bone marrow transplant.
Sensitivity Analysis 2--the modified cohort was limited to
patients who have been diagnosed with relapsed AML who received
chemotherapy and did not receive bone marrow transplant.
Sensitivity Analysis 3--the modified cohort was limited to
patients who have been diagnosed with AML and who did not receive bone
marrow transplant.
Sensitivity Analysis 4--the primary cohort was maintained,
but 100 percent of the charges for revenue centers grouped into the
``Pharmacy Charge Amount'' were excluded.
Sensitivity Analysis 5--identified patients who have been
diagnosed with AML in remission.
The applicant noted that, in all of the sensitivity analysis
scenarios, the average case-weighted standardized charge per case
exceeded the average case-weighted Table 10 MS-DRG threshold amount.
Based on all of the analyses above, the applicant maintained that
VYXEOSTM met the cost criterion. We invited public comments
on whether VYXEOSTM meets the cost criterion.
Comment: The applicant noted the detailed summary presented in the
proposed rule of the cost analysis of the VYXEOSTM,
including a primary cohort analysis and five sensitivity analyses. The
applicant stated that, in each of the analyses, it was demonstrated
that the average case-weighted standardized charge per case for the
applicable MS-DRGs exceeded the average case-weighted threshold amount
before considering the average per patient cost of VYXEOSTM
to the hospital.
Response: We appreciate the applicant's input.
After consideration of the public comments we received, we believe
that VYXEOSTM meets the cost criterion.
With regard to substantial clinical improvement, according to the
applicant, clinical data results have shown that the use of
VYXEOSTM represents a substantial clinical improvement for
the treatment of AML in newly diagnosed high-risk, older (60 years of
age and older) patients, marked by statistically significant
improvements in overall survival, event free survival and response
rates, and in relapsed patients age 18 to 65 years of age, where a
statistically significant improvement in overall survival has been
documented for the poor-risk subset of patients as defined by the
European Prognostic Index. In both groups of patients, the applicant
stated that there was significant improvement in survival for the high-
risk patient group. The applicant provided the following specific
clinical data results.
The applicant stated that clinical data results show that
treatment with VYXEOSTM for older patients (60 years of age
and older) who have been diagnosed with untreated, high-risk AML will
result in superior survival rates, as compared to patients treated with
conventional ``7+3'' free drug dosing. The applicant provided a summary
of the pivotal Phase III Study 301 in which 309 patients were enrolled,
with 153 patients randomized to the VYXEOSTM treatment arm
and 156 to the ``7+3'' free drug dosing treatment arm. Among patients
who were 60 to 69 years old, there were 96 patients in the
VYXEOSTM treatment arm and 102 in the ``7+3'' free drug
dosing treatment arm. For patients who were 70 to 75 years old, there
were 57 and 54 patients in each treatment arm, respectively. The
applicant noted that the data results from the Phase III Study 301
demonstrated that first-line treatment of patients diagnosed with high-
risk AML in the VYXEOSTM treatment arm resulted in
substantially greater median overall survival of 9.56 months versus
5.95 months in the ``7+3'' free drug dosing treatment arm (hazard ratio
of 0.69; p=0.005).
The applicant further asserted that high-risk, older
patients (60 years old and older) previously untreated for diagnoses of
AML will have a lower risk of early death when treated with
VYXEOSTM than those treated with the conventional ``7+3''
free drug dosing. The applicant cited Medeiros, et al.,\82\ which
reported a large observational study of Medicare beneficiaries and
noted the following: The data result of the study showed that 50 to 60
percent of elderly patients diagnosed with AML remain untreated
following diagnosis; treated patients were more likely younger, male,
and married, and less likely to have secondary diagnoses of AML, poor
performance indicators, and poor comorbidity scores compared to
untreated patients; and in multivariate survival analyses, treated
patients exhibited a significant 33 percent lower risk of death
compared to untreated patients.
---------------------------------------------------------------------------
\82\ Medeiros, B., et al., ``Big data analysis of treatment
patterns and outcomes among elderly acute myeloid leukemia patients
in the United States'', Ann Hematol, 2015, vol. 94(7), pp. 1127-
1138.
---------------------------------------------------------------------------
Based on data from the Phase III Study 301,\83\ the applicant cited
the following results: The rate of 60-day mortality was less in the
VYXEOSTM treatment arm (13.7 percent) versus the ``7+3''
free drug dosing treatment arm (21.2 percent); the reduction in early
mortality was due to fewer deaths from refractory AML (3.3 percent
versus 11.3 percent), with very similar rates of 60-day mortality due
to adverse events (10.4 percent versus 9.9 percent); there were fewer
deaths in the VYXEOSTM treatment arm versus the ``7+3'' free
drug dosing treatment arm during the treatment phase (7.8 percent
versus 11.3 percent); and there were fewer deaths in the
VYXEOSTM treatment arm during the follow-up phase than in
the ``7+3'' free drug dosing treatment arm (59.5 percent versus 71.5
percent).
---------------------------------------------------------------------------
\83\ Lancet, J., et al., ``Final results of a Phase III
randomized trial of VYXEOS (CPX-351) versus 7+3 in older patients
with newly diagnosed, high-risk (secondary) AML''. Abstract and oral
presentation at American Society of Clinical Oncology (ASCO), June
2016.
---------------------------------------------------------------------------
The applicant asserted that high-risk, older patients (60
years old and older) previously untreated for a diagnosis of AML
exhibited statistically significant improvements in response rates
after treatment with VYXEOSTM versus treatment with the
conventional ``7+3'' free drug chemotherapy dosing, suggesting that the
use of VYXEOSTM is a superior pre-transplant induction
treatment versus ``7+3'' free drug dosing. Restoration of normal
hematopoiesis is the ultimate goal of any therapy for AML diagnoses.
The first phase of treatment consists of induction chemotherapy, in
which the goal is to ``empty'' the bone marrow of all hematopoietic
elements (both benign and malignant), and to allow repopulation of the
marrow with normal cells, thereby yielding remission. According to the
applicant, post-induction response rates were
[[Page 41303]]
significantly higher following the use of VYXEOSTM, which
elicited a 47.7 percent total response rate and a 37.3 percent rate for
CR, whereas the total response and CR rates for the ``7+3'' free drug
dosing arm were 33.3 percent and 25.6 percent, respectively. The CR+CRi
rates for patients who were 60 to 69 years of age were 50.0 percent in
the VYXEOSTM treatment arm and 36.3 percent in the ``7+3''
free drug dosing treatment arm, with an odds ratio of 1.76 (95 percent
CI, 1.00-3.10). For patients who were 70 to 75 years old, the rates of
CR+CRi were 43.9 percent in the VYXEOSTM treatment arm and
27.8 percent in the ``7+3'' free drug dosing treatment arm.
The applicant asserted that VYXEOSTM treatment
will enable high-risk, older patients (60 years old and older) to
bridge to allogeneic transplant, and VYXEOSTM treated
responding patients will have markedly better outcomes following
transplant. The applicant stated that diagnoses of secondary AML are
considered incurable with standard chemotherapy approaches and, as with
other high-risk hematological malignancies, transplantation is a useful
treatment alternative. The applicant further stated that autologous
HSCT has limited effectiveness and at this time, only allogeneic HSCT
with full intensity conditioning has been reported to produce long-term
remissions. However, the applicant stated that the clinical study by
Medeiros, et al. reported that, while the use of allogeneic HSCT is
considered a potential cure for AML, its use is limited in older
patients because of significant baseline comorbidities and increased
transplant-related morbidity and mortality. Patients in either
treatment arm of the Phase III Study 301 responding to induction with a
CR or CR+CRi (n=125) were considered for allogeneic hematopoietic cell
transplant (HCT) when possible. In total, 91 patients were
transplanted: 52 (34 percent) from the VYXEOSTM treatment
arm and 39 (25 percent) from the ``7+3'' free drug dosing treatment
arm. Patient and AML characteristics were similar according to
randomized arm, including percentage of patients in each treatment arm
that underwent transplant in CR+CRi status. However, the applicant
noted that the VYXEOSTM treatment arm contained a higher
percentage of older patients (70 years old or older) who were
transplanted (VYXEOSTM, 31 percent; ``7+3'' free drug
dosing, 15 percent).\84\
---------------------------------------------------------------------------
\84\ Stone Hematology 2004; Gordon AACR 2016; NCI. Available at:
www.cancer.gov.
---------------------------------------------------------------------------
According to the applicant, patient outcome following transplant
strongly favored patients in the VYXEOSTM treatment arm. The
Kaplan-Meier analysis of the 91 transplanted patients landmarked at the
time of HCT showed that patients in the VYXEOSTM treatment
arm had markedly better overall survival (hazard ratio 0.46; p=0.0046).
The time-dependent Adjustment Model (Cox proportional hazard ratio) was
used to evaluate the contribution of VYXEOSTM treatment to
overall survival rate after adjustment for transplant and showed that
VYXEOSTM treatment remained a significant contributor, even
after adjusting for transplant. The time-dependent Cox hazard ratio for
overall survival rates in the VYXEOSTM treatment arm versus
the ``7+3'' free drug dosing treatment arm was 0.51 (95 percent CI,
0.35-0.75; p=.0007).
The applicant asserted that VYXEOSTM treatment
of previously untreated older patients (60 years old and older)
diagnosed with high-risk AML increases the response rate and improves
survival compared to conventional ``7+3'' free drug dosing treatment in
patients diagnosed with FLT3 mutation. The applicant noted the
following: Approximately 20 to 30 percent of AML patients harbor some
form of FLT3 mutation, AML patients with a FLT3 mutation have a higher
relapse rate and poorer prognosis than the overall population diagnosed
with AML, and the most common type of mutation is internal tandem
duplication (ITD) mutation localized to a membrane region of the
receptor.
The applicant cited Gordon, et al., 2016,\85\ which reported on the
significant anti-leukemic activity of VYXEOSTM treatment in
AML blasts exhibiting high-risk characteristics, including FLT3-ITD,
that are typically associated with poor outcomes when treated with
conventional ``7+3'' free drug dosing treatment. To determine whether
the improved complete remission and overall survival rates of treatment
using VYXEOSTM as compared to conventional ``7+3'' free drug
dosing treatment are attributable to liposome-mediated altered drug PK
or direct cellular interactions with specific AML blast samples, the
authors evaluated cytotoxicity in 53 AML patient specimens.
Cytotoxicity results were correlated with patient characteristics, as
well as VYXEOSTM treatment cellular uptake and molecular
phenotype status including FLT3-ITD, which is a predictor of poor
patient outcomes to conventional ``7+3'' free drug dosing treatment.
The applicant stated that a notable result from this research was the
observation that AML blasts exhibiting the FLT3-ITD phenotype exhibited
some of the lowest IC50 (the 50 percent inhibitory
concentration) values and, as a group, were five-fold more sensitive to
the VYXEOSTM treatment than those with wild type FLT3. In
addition, there was evidence that increased sensitivity to
VYXEOSTM treatment was associated with increased uptake of
the drug-laden liposomes by the patient-derived AML blasts. The
applicant noted that Gordon, et al. 2016, concluded taken together, the
data are consistent with clinical observations where
VYXEOSTM treatment retains significant anti-leukemic
activity in AML patients exhibiting high-risk characteristics. The
applicant also noted that a subanalysis of Phase III Study 301
identified 22 patients who had been diagnosed with FLT3 mutation in the
VYXEOSTM treatment arm and 20 in the ``7+3'' free drug
dosing treatment arm, which resulted in the following response rates of
FLT3 mutated patients, which were higher with VYXEOSTM
treatments (15 of 22, 68.2 percent) versus ``7+3'' free drug dosing
treatments (5 of 20, 25.0 percent); and the Kaplan-Meier analysis of
the 42 FLT3 mutated patients showed that patients in the
VYXEOSTM treatment arm had a trend towards better overall
survival rates (hazard ratio 0.57; p=0.093).
---------------------------------------------------------------------------
\85\ Gordon, M., Tardi, P., Lawrence, M.D., et al., ``CPX-351
cytotoxicity against fresh AML blasts increased for FLT3-ITD+ cells
and correlates with drug uptake and clinical outcomes,'' Abstract
287 and poster presented at AACR (American Association for Cancer
Research), April 2016.
---------------------------------------------------------------------------
The applicant asserted that younger patients (18 to 65
years old) with poor risk first relapse AML have shown higher response
rates with VYXEOSTM treatment versus conventional
``salvage'' chemotherapy. Overall, the applicant stated that the use of
VYXEOSTM had an acceptable safety profile in this patient
population based on 60-day mortality data. Study 205 \86\ was a
randomized study comparing VYXEOSTM treatment against the
investigator's choice of first ``salvage'' chemotherapy in patients who
had been diagnosed with relapsed AML after a first remission lasting
greater than 1 month (VYXEOSTM treatment arm, n=81 and
``7+3'' free drug dosing treatment arm, n=44; 18 to 65 years old).
Investigator's choice was almost always based on cytarabine +
anthracycline, usually with the addition
[[Page 41304]]
of one or two new agents. According to the applicant, treatment
involving VYXEOSTM demonstrated a higher rate of
morphological leukemia clearance among all patients, 43.2 percent
versus 40.0 percent, and the advantage was most apparent in poor-risk
patients, 78.7 percent versus 44.4 percent, as defined by the European
Prognostic Index (EPI). In the subset analysis of this EPI poor-risk
patient subset, the applicant stated there was a significant
improvement in survival rate (6.6 versus 4.2 months median, hazard
ratio=0.55, p=0.02) and improved response rate (39.3 percent versus 27
percent). The applicant also noted the following: The safety profile
for the use of VYXEOSTM was qualitatively similar to that of
control ``salvage'' therapy, with nearly identical 60-day mortality
rates (14.8 percent versus 15.9 percent); among VYXEOSTM
treated patients, those with no history of prior HSCT (n=59) had higher
response rates (54.2 percent versus 37.8 percent) and lower 60-day
mortality (10.2 percent versus 16.2 percent); overall, the use of
VYXEOSTM had acceptable safety based on 60-day mortality
data, with somewhat higher frequency of neutropenia and
thrombocytopenia-related grade III-IV adverse events. Even though these
patients are younger (18 to 65 years old) than the population studied
in Phase III Study 301 (60 years old and older), Study 205 patients
were at a later stage of the disease and almost all had responded to
first-line therapy (cytarabine + anthracycline) and had relapsed. The
applicant also cited Cortes, et al. 2015,\87\ which reported that
patients who have been diagnosed with first relapse AML have limited
likelihood of response and short expected survival following
``salvage'' treatment with the results from literature showing that:
---------------------------------------------------------------------------
\86\ Cortes, J., et al., ``Significance of prior HSCT on the
outcome of salvage therapy with CPX-351 or conventional chemotherapy
among first relapse AML patients.'' Abstract and poster presented at
ASH 2011.
\87\ Cortes, J., et al., (2015), ``Phase II, multicenter,
randomized trial of CPX-351 (cytarabine:daunorubicin) liposome
injection versus intensive salvage therapy in adults with first
relapse AML,'' Cancer, January 2015, pp. 234-42.
---------------------------------------------------------------------------
Mitoxantrone, etoposide, and cytarabine induced response
in 23 percent of patients, with median overall survival of only 2
months.
Modulation of deoxycitidine kinase by fludarabine led to
the combination of fludarabine and cytarabine, resulting in a 36
percent CR rate with median remission duration of 39 weeks.
First salvage gemtuzumab ozogamicin induced CR+CRp (or
CR+CRi) response in 30 percent of patients with CD33+AML and, for
patients with short first CR durations, appeared to be superior to
cytarabine-based therapy.
The applicant noted that Study 205 results showed the use of
VYXEOSTM retained greater anti-leukemic efficacy in patients
who have been diagnosed with poor-risk first relapse AML, and produced
higher morphological leukemia clearance rates (78.7 percent) compared
to conventional ``salvage'' therapy (44 percent). The applicant further
noted that, overall, the use of VYXEOSTM had acceptable
safety profile in this patient population based on 60-day mortality
data.
Based on all of the data presented above, the applicant concluded
that VYXEOSTM represents a substantial clinical improvement
over existing technologies. However, in the proposed rule, we stated we
were concerned that, although there was an improvement in a number of
outcomes in Phase III Study 301, specifically overall survival rate,
lower risk of early death, improved response rates, better outcomes
following transplant, increased response rate and overall survival in
patients diagnosed with FLT3 mutation, and higher response rates versus
conventional ``salvage'' chemotherapy in younger patients diagnosed
with poor-risk first relapse, the improved outcomes may not be
statistically significant. Furthermore, we indicated we were concerned
that the overall improvement in survival from 5.95 months to 9.56
months may not represent a substantial clinical improvement. In
addition, the rate of adverse events in both treatment arms of Study
205, given the theoretical benefit of reduced toxicity with the
liposomal formulation, was similar for both the VYXEOSTM and
``7+3''free drug treatment groups. Therefore, we also were concerned
that there is a similar rate of adverse events, such as febrile
neutropenia (68 percent versus 71 percent), pneumonia (20 percent
versus 15 percent), and hypoxia (13 percent versus 15 percent), with
the use of VYXEOSTM as compared with the conventional
``7+3'' free drug regimen.
We invited public comments on whether VYXEOSTM meets the
substantial clinical improvement criterion.
Comment: Several commenters supported the use of
VYXEOSTM as a viable treatment option in the treatment of
older adults who have been diagnosed with high-risk AML, and believed
that clinically meaningful survival and response improvements have been
and can be achieved for a highly difficult to treat population of
patients with extremely limited treatment options. The applicant
summarized the efficacy outcomes of the pivotal Phase III Study 301 and
noted that significant improvement in overall survival was achieved
with a hazard ratio of 0.69, p=0.005. The applicant indicated that,
although many days of increased survival are desired rather than few,
clinical benefit cannot be determined solely by the absolute number of
days or months of survival increase. Rather, clinical benefit is
determined by the relative improvement in survival. The applicant
stated that, based on the data results from the Phase III Study 301,
the observed improvement in median survival was 3.61 months (Control,
5.95m versus VYXEOS, 9.56m). In other words, a 3.61 month increase in
median survival is substantial and of great benefit given an expected
median survival of only 5.95 months for patients treated with control
arm therapy. The applicant believed that this result was statistically
significant and demonstrates clinically high benefits.
Response: We appreciate the commenters' and the applicant's input
in response to our concerns. After consideration of the public comments
we received, we believe that based on the statistically significant
increase in median survival rate from the Phase III Study 301,
VYXEOSTM is a treatment option which offers a substantial
clinical improvement over standard therapy for patients who have been
diagnosed with AML. Therefore, we believe that VYXEOSTM
meets the substantial clinical improvement criterion.
Based on evaluation of the new technology add-on payment
application and consideration of the public comments we received, we
have determined that VYXEOSTM meets all of the criteria for
approval for new technology add-on payments. Therefore, we are
approving new technology add-on payments for VYXEOSTM for FY
2019. We expect that VYXEOSTM will be administered, as
indicated, for use in the treatment of adults who have been newly
diagnosed with therapy-related acute myeloid leukemia (t-AML) or AML
with myelodysplasia-related changes (AML-MRC). Cases involving the use
of VYXEOSTM that are eligible for new technology add-on
payments will be identified by ICD-10-PCS procedure codes: XW033B3
(Introduction of cytarabine and caunorubicin liposome antineoplastic
into peripheral vein, percutaneous approach, new technology group 3);
and XW043B3 (Introduction of cytarabine and daunorubicin liposome
antineoplastic into central vein, percutaneous approach, new technology
group 3).
[[Page 41305]]
In its application, the applicant estimated that the average cost
of a single vial for VYXEOSTM is $7,750 (daunorubicin 44 mg/
m2 and cytarabine 100 mg/m2). The applicant stated that the first
induction of 6 vials is administered in the inpatient hospital setting,
with 31 percent of the patients receiving a second induction of an
administration of 4 vials. Of the 31 percent of the patients that
receive the second induction, 85 percent of the patients receive the
second induction in the inpatient hospital setting during the same
inpatient stay of the first induction. The applicant further stated
that 32 percent of all of the patients receive a first consolidation
therapy of an administration of 3 vials, with 50 percent of these
patients being treated in the inpatient hospital setting. The applicant
also indicated that 50 percent of all of the patients receive a second
consolidation therapy of an administration of 3 vials, with 40 percent
of these patients being treated in the inpatient hospital setting. As
is our past practice, based on the information above, we believe that
it is appropriate to use an average to set the maximum amount of vials
used in the inpatient hospital setting. For the induction therapy, all
patients receive an administration of 6 vials for the first induction
in the inpatient hospital setting, with 31 percent of all of the
patients receiving a second induction therapy of an administration of 4
vials--of which 85 percent of these patients are treated in the
inpatient hospital setting during the same stay as the first induction
therapy. Therefore, we computed the average of 6 vials for the first
induction plus 3.4 vials for the second induction (4 vials * 0.85),
which results in a maximum average of 9.4 vials used in the inpatient
hospital setting. Therefore, the maximum average cost for
VYXEOSTM used in the inpatient hospital setting is $72,850
($7,750 cost per vial * 9.4 vials). Under Sec. 412.88(a)(2), we limit
new technology add-on payments 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 a case involving the use of
VYXEOSTM is $36,425.
c. VABOMERETM (Meropenem-vaborbactam)
Melinta Therapeutics, Inc., submitted an application for new
technology add-on payments for VABOMERETM for FY 2019.
VABOMERETM is indicated for use in the treatment of adult
patients who have been diagnosed with complicated urinary tract
infections (cUTIs), including pyelonephritis, caused by designated
susceptible bacteria. VABOMERETM received FDA approval on
August 29, 2017.
Complicated urinary tract infections (cUTIs) are defined as chills,
rigors, or fever (temperature of greater than or equal to 38.0 [deg]C);
elevated white blood cell count (greater than 10,000/mm3), or left
shift (greater than 15 percent immature PMNs); nausea or vomiting;
dysuria, increased urinary frequency, or urinary urgency; lower
abdominal pain or pelvic pain. Acute pyelonephritis is defined as
chills, rigors, or fever (temperature of greater than or equal to 38.0
[deg]C); elevated white blood cell count (greater than 10,000/mm3), or
left shift (greater than 15 percent immature PMNs); nausea or vomiting;
dysuria, increased urinary frequency, or urinary urgency; flank pain;
costo-vertebral angle tenderness on physical examination. Risk factors
for infection with drug-resistant organisms do not, on their own,
indicate a cUTI.\88\ The increasing incidence of multidrug-resistant
gram-negative bacteria, such as carbapenem-resistant Enterobacteriacea
(CRE), has resulted in a critical need for new antimicrobials.
---------------------------------------------------------------------------
\88\ Hooton, T. and Kalpana, G., 2018, ``Acute complicated
urinary tract infection (including pyelonephritis) in adults,'' In
A. Bloom (Ed.), UpToDate. Available at: https://www.uptodate.com/contents/acute-complicated-urinary-tract-infection-including-pyelonephritis-in-adults.
---------------------------------------------------------------------------
The applicant reported that it has developed a beta-lactamase
combination antibiotic, VABOMERETM, to treat cUTIs,
including those caused by certain carbapenem-resistant organisms. By
combining the carbapenem class antibiotic meropenem with vaborbactam,
VABOMERETM protects meropenem from degradation by certain
CRE strains.
The applicant stated that meropenem, a carbapenem, is a broad
spectrum beta-lactam antibiotic that works by inhibiting cell wall
synthesis of both gram-positive and gram-negative bacteria through
binding of penicillin-binding proteins (PBP). Carbapenemase producing
strains of bacteria have become more resistant to beta-lactam
antibiotics, such as meropenem. However, meropenem in combination with
vaborbactam, inhibits the carbapenemase activity, thereby allowing the
meropenem to bind PBP and kill the bacteria.
According to the applicant, vaborbactam, a boronic acid inhibitor,
is a first-in class beta-lactamase inhibitor. Vaborbactam blocks the
breakdown of carbapenems, such as meropenem, by bacteria containing
carbapenemases. Although vaborbactam has no antibacterial properties,
it allows for the treatment of resistant infections by increasing
bacterial sensitivity to meropenem. New carbapenemase producing strains
of bacteria have become more resistant to beta-lactam antibiotics.
However, meropenem in combination with vaborbactam, can inhibit the
carbapenemase enzyme, thereby allowing the meropenem to bind PBP and
kill the bacteria. The applicant stated that the vaborbactem component
of VABOMERETM helps to protect the meropenem from
degradation by certain beta-lactamases, such as Klebsiella pneumonia
carbapenemase (KPC). According to the applicant, VABOMERETM
is the first of a novel class of beta-lactamase inhibitors. The
applicant asserted that VABOMERETM's use of vaborbactam to
restore the efficacy of meropenem is a novel approach to fighting
antimicrobial resistance.
The applicant stated that VABOMERETM is indicated for
use in the treatment of adult patients 18 years old and older who have
been diagnosed with cUTIs, including pyelonephritis. The recommended
dosage of VABOMERETM is 4 grams (2 grams of meropenem and 2
grams of vaborbactam) administered every 8 hours by intravenous (IV)
infusion over 3 hours with an estimated glomerular filtration rate
(eGFR) greater than or equal to 50 ml/min/1.73m\2\. The recommended
dosage of VABOMERETM for patients with varying degrees of
renal function is included in the prescribing information. The duration
of treatment is for up to 14 days.
As discussed earlier, if a technology meets all three of the
substantial similarity 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, VABOMERETM is designed primarily
for the treatment of gram-negative bacteria that are resistant to other
current antibiotic therapies. The applicant stated that
VABOMERETM does not use the same or similar mechanism of
action to achieve a therapeutic outcome. The applicant asserted that
the vaborbactam component of VABOMERETM is a new class of
beta-lactamase inhibitor that protects meropenem from degradation by
certain enzymes such as carbapenamases. The applicant indicated that
the structure of
[[Page 41306]]
vaborbactam is distinctly optimized for inhibition of serine
carbapenamases and for combination with a carbapenem antibiotic. Beta-
lactamase inhibitors are agents that inhibit bacterial enzymes--enzymes
that destroy beta-lactam antibiotics and result in resistance to first-
line as well as ``last defense'' antimicrobials used in hospitals.
According to the applicant, in order for carbapenems to be effective
these enzymes must be inhibited. The applicant stated that the addition
of vaborbactam as a potent inhibitor against Class A and C serine beta-
lactamases, particularly KPC, represents a new mechanism of action.
According to the applicant, VABOMERETM's use of vaborbactam
to restore the efficacy of meropenem is a novel approach and that the
FDA's approval of VABOMERETM for the treatment of cUTIs
represents a significant label expansion because mereopenem alone
(without the addition of vaborbactam) is not indicated for the
treatment of patients with cUTI infections. Therefore, the applicant
maintained that this technology and resistance-fighting mechanism
involved in the therapeutic effect achieved by VABOMERETM is
distinct from any other existing product. The applicant noted that
VABOMERETM was designated as a qualified infectious disease
product (QIDP) in January 2014. This designation is given to
antibacterial products that treat serious or life-threatening
infections under the Generating Antibiotic Incentives Now (GAIN) title
of the FDA Safety and Innovation Act.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20300), we stated
that we believed, although the molecular structure of the vaborbactam
component of VABOMERETM is unique, the bactericidal action
of VABOMERETM is the same as meropenem alone. In addition,
we noted that there are other similar beta-lactam/beta-lactamase
inhibitor combination therapies currently available as treatment
options. We invited public comments on whether VABOMERETM's
mechanism of action is similar to other existing technologies.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant asserted that patients
who may be eligible to receive treatment involving
VABOMERETM include hospitalized patients who have been
diagnosed with a cUTI. These potential cases can be identified by a
variety of ICD-10-CM diagnosis codes. Therefore, potential cases
representing patients who have been diagnosed with a cUTI who may be
eligible for treatment involving VABOMERETM can be mapped to
multiple MS-DRGs. The following are the most commonly used MS-DRGs for
patients who have been diagnosed with a cUTI: MS-DRG 690 (Kidney and
Urinary Tract Infections without MCC); MS-DRG 853 (Infectious and
Parasitic Diseases with O.R. Procedure with MCC); MS-DRG 870
(Septicemia or Sever Sepsis with Mechanical Ventilation 96+ Hours); MS-
DRG 871 (Septicemia or Severe Sepsis without Mechanical Ventilation 96+
Hours with MCC); and MS-DRG 872 (Septicemia or Severe Sepsis without
Mechanical Ventilation 96+ Hours without MCC). Potential cases
representing patients who may be eligible for treatment with
VABOMERETM would be assigned to the same MS-DRGs as cases
representing hospitalized patients who have been diagnosed with a cUTI.
With respect to the third criterion, whether the use of the
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, the applicant
asserted that the use of VABOMERETM would treat a different
patient population than existing and currently available treatment
options. According to the applicant, VABOMERETM's use of
vaborbactam to restore the efficacy of meropenem is a novel approach to
fighting the global and national public health crisis of antimicrobial
resistance, and as such, the use of VABOMERETM reaches
different and expanded patient populations. The applicant further
asserted that future patient populations are saved as well because the
growth of resistant infections is slowed. The applicant believed that,
because of the threat posed by gram-negative bacterial infections and
the limited number of available treatments currently on the market or
in development, the combination structure and development of
VABOMERETM and its potential expanded use is new. We stated
in the proposed rule that while the applicant believes that
VABOMERETM treats a different patient population, we note
that VABOMERETM is only approved for use in the treatment of
adult patients who have been diagnosed with cUTIs. Therefore, we stated
that it appears that VABOMERETM treats the same population
(adult patients with a cUTI) and there are already other treatment
options available for diagnoses of cUTIs.
In the proposed rule, we stated that we were concerned
VABOMERETM may be substantially similar to existing beta-
lactam/beta-lactamase inhibitor combination therapies. As noted in the
proposed rule and above, we were concerned that VABOMERETM
may have a similar mechanism of action, treats the same population
(patients with a cUTI) and would be assigned to the same MS-DRGs
(similar to existing beta-lactam/beta-lactamase inhibitor combination
therapies currently available as treatment options). We invited public
comments on whether VABOMERETM meets the substantial
similarity criteria and the newness criterion.
Comment: The applicant addressed the issue regarding the
substantial similarity criteria and recommended CMS apply its standards
under the newness criterion in a manner that recognizes the innovative
nature and unique aspects of VABOMERETM. The applicant
explained that meropenem alone is not indicated to treat a diagnosis of
a cUTI and, moreover, is not active against KPC-producing CRE. The
applicant stated that the action of the vaborbactam's protection of the
meropenem is fundamental and essential to how VABOMERETM
acts on and inhibits bacterial enzymes, and allows
VABOMERETM to treat even those infections that would
otherwise be resistant and not susceptible to therapy with meropenem
alone. The applicant believed that, accordingly,
VABOMERETM's mechanism of action is distinct from that of
meropenem and is not the same. The applicant further explained that,
meropenem is degraded by beta-lactamases enzymes, including KPC
enzymes, and, therefore, is ineffective against KPC-producing CRE. The
applicant indicated that VABOMERETM, in contrast, is not
degraded by these enzymes and is able to provide effective treatment
against infections that are not susceptible to meropenem. The applicant
also reiterated that, unlike meropenem alone, VABOMERETM is
on-label indicated for the use in the treatment of a cUTI diagnosis.
Several commenters believed that VABOMERETM may be
substantially similar to other existing therapies. The applicant
believed that CMS' application of the ``substantial similarity''
standards for newness as described in prior IPPS rulemakings, including
aspects of CMS' discussion of these criteria in the FY 2019 IPPS/LTCH
PPS proposed rule as applied to VABOMERETM, are restrictive
and may impose unnecessarily narrow standards for newness that are not
included in the statute or regulations. The applicant stated that, if
applied as suggested in the proposed rule, CMS may not account for the
realities and circumstances involved in developing and bringing a new
therapy--particularly a new antibiotic--to the U.S. market. The
applicant
[[Page 41307]]
suggested CMS apply its newness standards in a manner that recognizes
the innovative nature and unique aspects of new technologies, like
VABOMERETM, consistent with the text and spirit of the new
technology add-on payment provisions.
Other commenters stated that, given the recognized shortage of new
antibiotics, the unique benefits of VABOMERETM should not be
ignored because of substantial similarities to other medicines.
Response: We appreciate the applicant's and commenters' input. We
agree that VABOMERETM has a unique mechanism of action that
is not similar to other existing technologies because it is a new class
of beta-lactamase inhibitor that protects meropenem from degradation by
certain enzymes such as carbapenamases. We agree that the addition of
vaborbactam as a potent inhibitor against Class A and C serine beta-
lactamases, particularly KPC, represents a new mechanism of action.
After consideration of the public comments we received, we believe that
VABOMERETM is not substantially similar to existing
technologies and meets the newness criterion.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that the technology meets the cost
criterion. In order to identify the range of MS-DRGs to which cases
representing potential patients who may be eligible for treatment using
VABOMERETM may map, the applicant used the Premier Research
Database from 2nd Quarter 2015 to 4th Quarter 2016. According to the
applicant, Premier is an electronic laboratory, pharmacy, and billing
data repository that collects data from over 600 hospitals and captures
nearly 20 percent of U.S. hospitalizations. The applicant's list of
most common MS-DRGs is based on data regarding CRE from the Premier
Research Database. According to the applicant, approximately 175 member
hospitals also submit microbiology data, which allowed the applicant to
identify specific pathogens such as CRE infections. Using the Premier
Research Database, the applicant identified over 350 MS-DRGs containing
data for 2,076 cases representing patients who had been hospitalized
for CRE infections. The applicant used the top five most common MS-
DRGs: MS-DRG 871 (Septicemia or Severe Sepsis without Mechanical
Ventilation >96 Hours with MCC), MS-DRG 853 (Infectious and Parasitic
Disease with O.R. Procedure with MCC), MS-DRG 870 (Septicemia or Severe
Sepsis with Mechanical Ventilation >96 Hours), MS-DRG 872 (Septicemia
or Severe Sepsis without Mechanical Ventilation >96 Hours without MCC),
and MS-DRG 690 (Kidney and Urinary Tract Infections without MCC), to
which 627 cases representing potential patients who may be eligible for
treatment involving VABOMERETM, or approximately 30.2
percent of the total cases identified, mapped.
The applicant reported that the resulting 627 cases from the
identified top 5 MS-DRGs have an average case-weighted unstandardized
charge per case of $74,815. In the FY 2019 IPPS/LTCH PPS proposed rule
(83 FR 20301), we noted that, instead of using actual charges from the
Premier Research Database, the applicant computed this amount based on
the average case-weighted threshold amounts in Table 10 from the FY
2018 IPPS/LTCH PPS final rule. For the rest of the analysis, the
applicant adjusted the average case-weighted threshold amounts
(referred to above as the average case-weighted unstandardized charge
per case) rather than the actual average case-weighted unstandardized
charge per case from the Premier Research Database. According to the
applicant, based on the Premier data, $1,999 is the mean antibiotic
costs of treating patients hospitalized with CRE infections with
current therapies. The applicant explained that it identified 69
different regimens that ranged from 1 to 4 drugs from a study conducted
to understand the current management of patients diagnosed with CRE
infections. Accordingly, the applicant estimated the removal of charges
for a prior technology of $1,999. The applicant then standardized the
charges. The applicant applied an inflation factor of 9.357 percent
from the FY 2018 IPPS/LTCH PPS final rule (82 FR 38527) to inflate the
charges. At the time of the development of the proposed rule, the
applicant noted that it did not yet have sufficient charge data from
hospitals and would work to supplement its application with the
information once it was available. However, for purposes of calculating
charges, the applicant used the average charge as the wholesale
acquisition cost (WAC) price for a treatment duration of 14 days and
added this amount to the average charge per case. Using this estimate,
the applicant calculated the final inflated case-weighted standardized
charge per case as $91,304, which exceeded the average case-weighted
threshold amount of $74,815. Therefore, the applicant asserted that
VABOMERETM met the cost criterion.
In the proposed rule, we indicated we were concerned that, as noted
earlier, instead of using actual charges from the Premier Research
Database, the applicant computed the average case-weighted
unstandardized charge per case based on the average case-weighted
threshold amounts in Table 10 from the FY 2018 IPPS/LTCH PPS final
rule. Because the applicant did not demonstrate that the average case-
weighted standardized charge per case for VABOMERETM (using
actual charges from the Premier Research Database) would exceed the
average case-weighted threshold amounts in Table 10, we were unable to
determine if the applicant met the cost criterion. We invited public
comments on whether VABOMERETM met the cost criterion,
including with respect to the concern regarding the applicant's
analysis.
Comment: The applicant addressed CMS' concern regarding the cost
criterion and analysis and submitted a revised cost analysis in
response. The applicant conducted a revised analysis using claims from
the FY 2016 MedPAR to demonstrate that VABOMERETM meets the
cost criterion. To identify potential cases representing patients who
may be eligible for treatment involving VABOMERETM, the
applicant identified 34 ICD-10-CM diagnosis codes from claims from the
FY 2016 MedPAR specific to the anticipated VABOMERETM
patient population. The applicant distinguished the 34 ICD-10-CM
diagnosis codes by three different subsets, with Subset 1 based on 17
of the 34 ICD-10-CM diagnosis codes; Subset 2 based on 13 of the 34
ICD-10-CM diagnosis codes; and Subset 3 based on 8 of the 34 ICD-10-CM
diagnosis codes. The applicant noted that the 8 ICD-10-CM diagnosis
codes used in the Subset 3 analysis also are included in all three of
the analyses, and the 13 ICD-10-CM diagnosis codes included in the
Subset 2 analysis also are included among the 17 diagnosis codes used
in the Subset 1 analysis.
For each subset, the applicant conducted a cost analysis for 100
percent of the identified cases, 75 percent of the identified cases,
the top 20 MS-DRGs to which potential cases would map, and the top 10
MS-DRGs to which potential cases would map. For each subset, the
applicant performed the following: (1) Calculated the case-weighted
unstandardized charge per case; (2) removed 100 percent of the drug
charges from the relevant cases in order to conservatively estimate for
charges for drugs that potentially may be replaced by
VABOMERETM; (3) standardized the charges; (4) applied the 2-
year inflation factor of 9.357 percent from the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38527); (5) added the charges for
VABOMERETM (the
[[Page 41308]]
applicant calculated the charges for VABOMERETM by
converting the costs of VABOMERETM to charges and dividing
the costs by the national CCR of 0.194 for ``Drugs'' from the FY2018
IPPS/LTCH PPS final rule (82 FR 38103)); and (6) computed the inflated
average case-weighted standardized charge per case and the average
case-weighted threshold amount.
The applicant stated that the cost of VABOMERETM is $165
per vial. The applicant indicated that a patient receives two vials per
dose and three doses per day. Therefore, the per-day cost of
VABOMERETM is $990 per patient. The duration of therapy,
consistent with the Prescribing Information, is up to 14 days.
Therefore, the applicant estimated that the cost of
VABOMERETM to the hospital, per patient, is $13,860. The
applicant believed that, based on limited data from the product's
launch, approximately 80 percent of VABOMERETM's usage would
be in the inpatient hospital setting, and approximately 20 percent of
VABOMERETM's usage may take place outside of the inpatient
hospital setting. Therefore, the applicant stated that the average
number of days of VABOMERETM administration in the inpatient
hospital setting is estimated at 80 percent of 14 days, or
approximately 11.2 days. As a result, the applicant calculated that the
total inpatient cost is $11,088 ($990 * 11.2 days), which was then
converted to charges in the calculations above.
The applicant stated that each subset demonstrated the average
case-weighted standardized charge per case exceeded the average case-
weighted threshold amount. Below are three tables, one for each subset,
showing that the average case-weighted standardized charge per case
exceeded the average case-weighted threshold amount.
----------------------------------------------------------------------------------------------------------------
100 Percent of 75 Percent of
Subset 1 cost analysis the identified the identified Top 20 Top 10
cases cases MS[dash]DRGs MS[dash]DRGs
----------------------------------------------------------------------------------------------------------------
Case[dash]Weighted Unstandardized Charge Per $66,978 $61,313 $54,894 $56,004
Case...........................................
Inflated Average Case-Weighted Standardized 112,692 107,943 102,924 103,444
Charge Per Case................................
Average Case-Weighted Threshold................. 56,213 54,782 51,993 52,941
Difference...................................... 56,479 53,161 50,931 50,503
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
100 Percent of 75 Percent of
Subset 2 cost analysis the identified the identified Top 20 Top 10
cases cases MS[dash]DRGs MS[dash]DRGs
----------------------------------------------------------------------------------------------------------------
Case[dash]Weighted Unstandardized Charge Per $66,135 $60,486 $54,220 $55,267
Case...........................................
Inflated Average Case-Weighted Standardized 112,108 107,340 102,430 102,892
Charge Per Case................................
Average Case-Weighted Threshold................. 55,924 54,421 51,749 52,683
Difference...................................... 56,184 52,919 50,681 50,209
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
100 Percent of 75 Percent of
Subset 3 cost analysis the identified the identified Top 20 Top 10
cases cases MS[dash]DRGs MS[dash]DRGs
----------------------------------------------------------------------------------------------------------------
Case[dash]Weighted Unstandardized Charge Per $66,295 $60,215 $54,264 $55,273
Case...........................................
Inflated Average Case-Weighted Standardized 112,168 107,111 102,444 102,886
Charge Per Case................................
Average Case-Weighted Threshold................. 56,014 54,333 51,823 52,733
Difference...................................... 56,154 52,778 50,621 50,153
----------------------------------------------------------------------------------------------------------------
Response: We appreciate the applicant's response and revised cost
analysis. After consideration of the public comment and revised cost
analysis we received, we believe that VABOMERETM meets the
cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant believed that the results from the VABOMERETM
clinical trials clearly establish that VABOMERETM represents
a substantial clinical improvement for treatment of deadly, antibiotic
resistant infections. Specifically, the applicant asserted that
VABOMERETM offers a treatment option for a patient
population unresponsive to, or ineligible for, currently available
treatments, and the use of VABOMERETM significantly improves
clinical outcomes for a patient population as compared to currently
available treatments. The applicant provided the results of the
Targeting Antibiotic Non-sensitive Gram-Negative Organisms (TANGO) I
and II clinical trials to support its assertion.
TANGO I \89\ was a prospective, randomized, double-blinded trial of
VABOMERETM versus piperacillin-tazobactam in patients with
cUTIs and acute pyelonephritis (A/P). TANGO I is also a noninferiority
(NI) trial powered to evaluate the efficacy, safety, and tolerability
of VABOMERETM compared to piperacillin-tazobactam in the
treatment of cUTI, including AP, in adult patients. There were two
primary endpoints for this study, one for the FDA, which was cure or
improvement and microbiologic outcome of eradication at the end-of-
treatment (EOT) (day 5 to 14) in the proportion of patients in the
Microbiologic Evaluable Modified Intent-to-Treat (m-MITT) population
who achieved overall success (clinical cure or improvement and
eradication of baseline pathogen to <104 CFU/mL), and one for the
European Medicines Agency (EMA), which was the proportion of patients
in the co-primary m-MITT and Microbiologic Evaluable (ME) populations
who achieve a microbiologic outcome of eradication (eradication of
baseline pathogen to <103 CFU/mL) at the test-of-cure (TOC) visit (day
15 to 23). The trial enrolled 550 adult patients who were randomized
1:1 to receive
[[Page 41309]]
VABOMERETM as a 3-hour IV infusion every 8 hours, or
piperacillin 4g-tazobactam 500 mg as a 30 minute IV infusion every 8
hours, for at least 5 days for the treatment of a cUTI. Therapy was set
at a minimum of 5 days to fully assess the efficacy and safety of
VABOMERETM. After a minimum of 5 days of IV therapy,
patients could be switched to oral levofloxacin (500 mg once every 24
hours) to complete a total of 10-day treatment course (IV+oral), if
they met pre-specified criteria. Treatment was allowed for up to 14
days, if clinically indicated.
---------------------------------------------------------------------------
\89\ Vabomere Prescribing Information, Clinical Studies (August
2017), available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf.
---------------------------------------------------------------------------
Patient demographic and baseline characteristics were balanced
between treatment groups in the m-MITT population.
Approximately 93 percent of patients were Caucasian and 66
percent were females in both treatment groups.
The mean age was 54 years old with 32 percent and 42
percent of the patients 65 years old and older in the
VABOMERETM and piperacillin/tazobactam treatment groups,
respectively.
Mean body mass index was approximately 26.5 kg/m2 in both
treatment groups.
Concomitant bacteremia was identified in 12 (6 percent)
and 15 (8 percent) of the patients at baseline in the
VABOMERETM and piperacillin/tazobactam treatment groups,
respectively.
The proportion of patients who were diagnosed with
diabetes mellitus at baseline was 17 percent and 19 percent in the
VABOMERETM and piperacillin/tazobactam treatment groups,
respectively.
The majority of the patients (approximately 90 percent)
were enrolled from Europe, and approximately 2 percent of the patients
were enrolled from North America. Overall, in both treatment groups, 59
percent of the patients had pyelonephritis and 40 percent had a cUTI,
with 21 percent and 19 percent of the patients having a non-removable
and removable source of infection, respectively.
Mean duration of IV treatment in both treatment groups was 8 days
and mean total treatment duration (IV and oral) was 10 days; patients
with baseline bacteremia could receive up to 14 days of therapy (IV and
oral). Approximately 10 percent of the patients in each treatment group
in the m-MITT population had a levofloxacin-resistant pathogen at
baseline and received levofloxacin as the oral switch therapy.
According to the applicant, this protocol violation may have impacted
the assessment of the outcomes at the TOC visit. These patients were
not excluded from the analysis of adverse reactions (headache,
phlebitis, nausea, diarrhea, and others) occurring in 1 percent or more
of the patients receiving VABOMERETM, as the decision to
switch to oral levofloxacin was based on post-randomization factors.
Regarding the FDA primary endpoint, the applicant stated the
following:
Overall success rate at the end of IV treatment (day 5 to
14) was 98.4 percent and 94 percent for the VABOMERETM and
piperacillin/tazobactam treatment groups, respectively.
The TOC--7 days post IV therapy was 76.5 percent (124 of
162 patients) for the VABOMERETM group and 73.2 percent (112
of 153 patients) for the piperacillin/tazobactam group.
Despite being an NI trial, TANGO-I showed a statistically
significant difference favoring VABOMERETM in the primary
efficacy endpoint over piperacillin/tazobactam (a commonly used agent
for gram-negative infections in U.S. hospitals).
VABOMERETM demonstrated statistical superiority
over piperacillin-tazobactam with overall success of 98.4 percent of
patients treated with VABOMERETM in the TANGO-I clinical
trial compared to 94.0 percent for patients treated with piperacillin/
tazobactam, with a treatment difference of 4.5 percent and 95 percent
CI of (0.7 percent, 9.1 percent).
Because the lower limit of the 95 percent CI is also
greater than 0 percent, VABOMERETM was statistically
superior to piperacillin/tazobactam.
Because non-inferiority was demonstrated, then superiority
was tested. Further, the applicant asserted that a non-inferiority
design may have a ``superiority'' hypothesis imbedded within the study
design that is appropriately tested using a non-inferiority design and
statistical analysis. As such, according to the applicant, superiority
trials concerning antibiotics are impractical and even unethical in
many cases because one cannot randomize patients to receive inactive
therapies. The applicant stated that it would be unethical to leave a
patient with a severe infection without any treatment.
The EMA endpoint of eradication rates at TOC were higher
in the VABOMERETM group compared to the piperacillin/
tazobactam group in both the m-MITT (66.7 percent versus 57.7 percent)
and ME (66.3 percent and 60.4 percent) populations; however, it was not
a statistically significant improvement.
In the proposed rule, we noted that the eradication rates of the
EMA endpoint were not statistically significant. We invited public
comments with respect to our concern as to whether the FDA endpoints
demonstrating non-inferiority are statistically sufficient data to
support that VABOMERETM is a substantial clinical
improvement in the treatment of patients with a cUTI.
In its application, the applicant offered data from the TANGO-I
trial comparing VABOMERETM to piperacillin-tazobactam EOT/
TOC rates in the setting of cUTIs/AP, but in the proposed rule we
stated that the applicant did not offer a comparison to other
antibiotic treatments of cUTIs known to be effective against gram-
negative uropathogens, specifically other carbapenems.\90\ In the
proposed rule, we also noted that the study population is largely
European (98 percent), and given the variable geographic distribution
of antibiotic resistance we indicated we were concerned that the use of
piperacillin/tazobactam as the comparator may have skewed the
eradication rates in favor of VABOMERETM, or that the
favorable results would not be applicable to patients in the United
States. We invited public comments regarding the lack of a comparison
to other antibiotic treatments of cUTIs known to be effective against
gram-negative uropathogens, whether the comparator the applicant used
in its trial studies may have skewed the eradication rates in favor of
VABOMERETM, and if the favorable results would be applicable
to patients in the United States to allow for sufficient information in
evaluating substantial clinical improvement.
---------------------------------------------------------------------------
\90\ Golan, Y., 2015, ``Empiric therapy for hospital-acquired,
Gram-negative complicated intra-abdominal infection and complicated
urinary tract infections: a systematic literature review of current
and emerging treatment options,'' BMC Infectious Diseases, vol. 15,
pp. 313. http://doi.org/10.1186/s12879-015-1054-1.
---------------------------------------------------------------------------
In the proposed rule we noted that the applicant asserted that the
TANGO II study \91\ of monotherapy with VABOMERETM compared
to best available therapy (BAT) (salvage care of cocktails of toxic/
poorly efficacious last resort agents) for the treatment of CRE
infections showed important differences in clinical outcomes, including
reduced mortality, higher clinical cure at EOT and TOC, benefit in
important patient subgroups of HABP/VABP, bacteremia, renal impairment,
and immunocompromised and reduced AEs, particularly lower
nephrotoxicity in the study group. TANGO II is a multi-
[[Page 41310]]
center, randomized, Phase III, open-label trial of patients with
infections due to known or suspected CRE, including cUTI, AP, HABP/
VABP, bacteremia, or complicated intra-abdominal infection (cIAI).
Eligible patients were randomized 2:1 to monotherapy with
VABOMERETM or BAT for 7 to 14 days. There were no consensus
BAT regimes, it could include (alone or in combination) a carbapenem,
aminoglycoside, polymyxin B, colistin, tigecycline or ceftazidime-
avibactam.
---------------------------------------------------------------------------
\91\ Alexander, et al., ``CRE Infections: Results From a
Retrospective Series and Implications for the Design of Prospective
Clinical Trials,'' Open Forum Infectious Diseases.
---------------------------------------------------------------------------
A total of 72 patients were enrolled in the TANGO II trial. Of
these, 50 of the patients (69.4 percent) had a gram-negative baseline
organism (m-MITT population), and 43 of the patients (59.7 percent) had
a baseline CRE (mCRE-MITT population). Within the mCRE-MITT population,
20 of the patients had bacteremia, 15 of the patients had a cUTI/AP, 5
of the patients had HABP/VABP, and 3 of the patients had a cIAI. The
most common baseline CRE pathogens were K. pneumoniae (86 percent) and
Escherichia coli (7 percent). Cure rates of the mCRE-MITT population at
EOT for VABOMERETM and BAT groups were 64.3 percent and 40
percent, respectively, TOC, 7 days after EOT, were 57.1 percent and
26.7 percent, respectively, 28-day mortality was 17.9 percent (5 of 28
patients) and 33.3 percent (5 of 15 patients), respectively. The
applicant asserted that with further sensitivity analysis, taking into
account prior antibiotic failures among the VABOMERETM study
arm, the 28-day all-cause mortality rates were even lower among
VABOMERETM versus BAT patients (5.3 percent (1 of 19
patients) versus 33.3 percent (5 of 15 patients). Additionally, in July
2017, randomization in the trial was stopped early following a
recommendation by the TANGO II Data Safety Monitoring Board (DSMB)
based on risk-benefit considerations that randomization of additional
patients to the BAT comparator arm should not continue.
According to the applicant, subgroup analyses of the TANGO II
studies include an analysis of adverse events in which
VABOMERETM compared to BAT demonstrated the following:
VABOMERETM was associated with less severe
treatment emergent adverse events of 13.3 percent versus 28 percent.
VABOMERETM was less likely to be associated
with a significant increase in creatinine 3 percent versus 26 percent.
Efficacy results of the TANGO II trial cUTI/AP subgroup
demonstrated VABOMERETM was associated with an overall
success rate at EOT for the mCRE-MITT populations of 72 percent (8 of
11 patients) versus 50 percent (2 of 4 patients) and an overall success
rate at TOC of 27.3 percent (3 of 7 patients) versus 50 percent (2 of 4
patients).
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20303), we noted
that many of the TANGO II trial outcomes showing improvements in the
use of VABOMERETM over BAT are not statistically
significant. We also noted that the TANGO II study included a small
number of patients; the study population in the mCRE-MITT only included
43 patients. Additionally, the cUTI/AP subgroup analysis only included
a total of 15 patients and did not show an increased overall success
rate at TOC (27.3 percent versus 50 percent) over the BAT group. We
invited public comments with respect to our concern as to whether the
lack of statistically significant outcomes and the small number of
study participants allows for enough information to evaluate
substantial clinical improvement.
We invited public comments on whether the VABOMERETM
technology meets the substantial clinical improvement criterion,
including with respect to the specific concerns we have raised.
Comment: The applicant stated that VABOMERETM represents
and has demonstrated a substantial clinical improvement over other
existing available therapies. The applicant also stated that, in
particular, the results from the TANGO I and TANGO II, Phase III
clinical trials establish that VABOMERETM represents a
``substantial clinical improvement'' for treatment of deadly,
antibiotic-resistant infections. The applicant reiterated the results
of the TANGO I and TANGO II trials and noted the results show
VABOMERETM had a statistically significant higher response
rate than piperacillin/tazobactam in clinical cure and microbial
eradication. The applicant stated that, in TANGO I, piperacillin-
tazobactam was used as a comparator because it is very commonly used in
U.S. hospitals to treat infections, including severe UTIs. The
applicant indicated that, for example, as reflected in the
VABOMERETM Prescribing Information, the results of the TANGO
I demonstrate superiority as evidenced by the overall success rate at
the end of IV treatment (day 5 to 14) at 98.4 percent and 94 percent
for the VABOMERETM and piperacillin/tazobactam treatment
groups, respectively, and the TOC--7 days post IV therapy at 76.5
percent (124 of 162 patients) for the VABOMERETM group and
73.2 percent (112 of 153 patients) for the piperacillin/tazobactam
group. The applicant noted that, regarding non-inferiority and
superiority data, the statutory and regulatory standards for new
technology add-on payments do not preclude the relevance of non-
inferiority data for purposes of demonstrating that a new therapy meets
the ``substantial clinical improvement'' criterion. The applicant
indicated that CMS has previously approved an application for new
technology add-on payments and agreed that it represented a substantial
clinical improvement over existing technologies on the basis of non-
inferior data.
The applicant further indicated that, with regard to the size of
the study population for TANGO II, this study focused specifically on a
patient population known to have or suspected of having CRE. The
applicant further stated that, despite a concerted effort to search for
patients with CRE infection and intensive pre-screening and screening
activities across the globe, it took more than 2.5 years to enroll 77
patients. The applicant also noted that many other clinical studies in
the context of new antibiotics development and other areas have
involved similar or smaller cohorts of patients. According to the
applicant, in the specific context of TANGO II, approximately 100
patients were pre-screened for each individual enrolled patient. The
applicant stated that challenges are typical of the ``ultra-orphan''
world of antimicrobial development, where new treatments are needed,
and pathogen-focused or resistance-focused clinical trials are crucial
to accurately determine the efficacy of the treatment. The applicant
further stated that unfortunately, study challenges (including
difficulty consenting seriously-ill patients and their families,
restricted entry criteria, exclusion for prior antibiotics, among
others), along with a rare diagnosis, make larger trials with this
life-threatening condition quite difficult to conduct. The applicant
indicated that the patients enrolled in this study had a high incidence
of underlying comorbidities and a high disease severity, with
approximately 40 percent of the patients being immunocompromised and 75
percent with a Charlson Comorbidity Score >5. The applicant also noted
appreciation that CMS recognized these challenges, particularly in the
context of clinical trials for new antibiotic products that treat
serious and life-threatening infections. The applicant believed that,
for these reasons, the sample size used in the TANGO II trial does not
undermine or diminish the significance of its results. The applicant
indicated that the study focused specifically on
[[Page 41311]]
patients with known or suspected CRE and was powered specifically to
test certain endpoints, which it demonstrated--and, notably--did so
using VABOMERETM as a monotherapy. The applicant believed
that this is distinct from other clinical trials and underscores the
significance of the TANGO II results. The applicant further noted that
the TANGO II trial demonstrated certain improved outcomes with such
statistical significance that the independent data monitoring review
board recommended early termination of the randomization in the trial
to allow patients to cross over to the VABOMERETM arm
instead of the BAT arm in the trial.
One commenter agreed with CMS' concern that improved outcomes in
some trials may not be statistically significant and that the small
number of patients, and the lack of a comparison to other antibiotic
treatments of cUTIs known to be effective against uropathogens may not
support that VABOMERETM represents a substantial clinical
improvement in the treatment of patients diagnosed with a cUTI.
Response: We appreciate the commenter's input and the applicant's
responses to our concerns. After consideration of the public comments
we received, we believe that VABOMERETM offers a substantial
clinical improvement for patients who have limited or no alternative
treatment options because it is a new antibiotic that offers a
treatment option for a patient population unresponsive to currently
available treatments. Specifically, VABOMERETM is a novel,
first-in-class beta-lactamase inhibitor helps to protect the meropenem
from degradation by certain beta-lactamases, such as KPC. Additionally,
results from the TANGO II study demonstrate better outcomes regarding
28-day all-cause mortality taking into account prior antibiotic
failures (VABOMERETM patients (5.3 percent) versus BAT
patients (33.3 percent), p=0.03), as well as decreases nephrotoxicity
(VABOMERETM 11.1 percent versus BAT 24.0 percent).
Therefore, based on the above, we believe that VABOMERETM
represents a substantial clinical improvement.
In summary, we have determined that VABOMERETM meets all
of the criteria for approval of new technology add-on payments.
Therefore, we approving new technology add-on payments for
VABOMERETM for FY 2019. We note that, the applicant did not
request approval for the use of a unique ICD-10-PCS procedure code for
VABOMERETM for FY 2019. As a result, hospitals will be
unable to uniquely identify the use of VABOMERETM on an
inpatient claim using the typical coding of an ICD-10-PCS procedure
code. In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53352), with
regard to the oral drug DIFICIDTM, we revised our policy to
allow for the use of an alternative code set to identify oral
medications where no inpatient procedure is associated for the purposes
of new technology add-on payments. We established the use of a National
Drug Code (NDC) as the alternative code set for this purpose and
described our rationale for this particular code set. This change was
effective for payments for discharges occurring on or after October 1,
2012. We acknowledge that VABOMERETM is not an oral drug and
is administered by IV infusion, but it is the first approved new
technology aside from an oral drug with no uniquely assigned inpatient
procedure code. We, therefore, believe that the circumstances with
respect to the identification of eligible cases using
VABOMERETM are similar to those addressed in the FY 2013
IPPS/LTCH PPS final rule with regard to DIFICIDTM because we
do not have current ICD-10-PCS code(s) to uniquely identify the use of
VABOMERETM to make the new technology add-on payment.
Because we have determined that VABOMERETM has met all of
the new technology add-on payment criteria and cases involving the use
of VABOMERETM will be eligible for such payments for FY
2019, we need to use an alternative coding method to identify these
cases and make the new technology add-on payment for use of
VABOMERETM in FY 2019. Therefore, similar to the policy in
the FY 2013 IPPS/LTCH PPS final rule, in the place of an ICD-10-PCS
procedure code, FY 2019 cases involving the use of
VABOMERETM that are eligible for the FY 2019 new technology
add-on payments will be identified by the NDC of 65293-009-01
(VABOMERETM Meropenem-Vaborbactam Vial). Providers must code
the NDC in data element LIN03 of the 837i Health Care Claim
Institutional form in order to receive the new technology add-on
payment for procedures involving the use of VABOMERETM. The
applicant may request approval for a unique ICD-10-PCS procedure code
for FY 2020.
As discussed above, according to the applicant, the cost of
VABOMERETM is $165 per vial. A patient receives two vials
per dose and three doses per day. Therefore, the per-day cost of
VABOMERETM is $990 per patient. The duration of therapy,
consistent with the Prescribing Information, is up to 14 days.
Therefore, the estimated cost of VABOMERETM to the hospital,
per patient, is $13,860. Based on the limited data from the product's
launch, approximately 80 percent of VABOMERETM's usage would
be in the inpatient hospital setting, and approximately 20 percent of
VABOMERETM's usage may take place outside of the inpatient
hospital setting. Therefore, the average number of days of
VABOMERETM administration in the inpatient hospital setting
is estimated at 80 percent of 14 days, or approximately 11.2 days. As a
result, the total inpatient cost for VABOMERETM is $11,088
($990 * 11.2 days). Under Sec. 412.88(a)(2), we limit new technology
add-on payments 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 a case involving the use of VABOMERETM is $5,544 for FY
2019.
d. remed[emacr][supreg] System
Respicardia, Inc. submitted an application for new technology add-
on payments for the remed[emacr][supreg] System for FY 2019. According
to the applicant, the remed[emacr][supreg] System is indicated for use
as a transvenous phrenic nerve stimulator in the treatment of adult
patients who have been diagnosed with moderate to severe central sleep
apnea. The remed[emacr][supreg] System consists of an implantable pulse
generator, and a stimulation and sensing lead. The pulse generator is
placed under the skin, in either the right or left side of the chest,
and it functions to monitor the patient's respiratory signals. A
transvenous lead for unilateral stimulation of the phrenic nerve is
placed either in the left pericardiophrenic vein or the right
brachiocephalic vein, and a second lead to sense respiration is placed
in the azygos vein. Both leads, in combination with the pulse
generator, function to sense respiration and, when appropriate,
generate an electrical stimulation to the left or right phrenic nerve
to restore regular breathing patterns.
The applicant describes central sleep apnea (CSA) as a chronic
respiratory disorder characterized by fluctuations in respiratory
drive, resulting in the cessation of respiratory muscle activity and
airflow during sleep.\92\ The applicant reported that CSA, as a primary
disease, has a low prevalence in the United States population; and it
is
[[Page 41312]]
more likely to occur in those individuals who have cardiovascular
disease, heart failure, atrial fibrillation, stroke, or chronic opioid
usage. The apneic episodes which occur in patients with CSA cause
hypoxia, increased blood pressure, increased preload and afterload, and
promotes myocardial ischemia and arrhythmias. In addition, CSA
``enhances oxidative stress, causing endothelial dysfunction,
inflammation, and activation of neurohormonal systems, which contribute
to progression of underlying diseases.'' \93\
---------------------------------------------------------------------------
\92\ Jagielski, D., Ponikowski, P., Augostini, R., Kolodziej,
A., Khayat, R., Abraham, W.T., 2016, ``Transvenous Stimulation of
the Phrenic Nerve for the Treatment of Central Sleep Apnoea: 12
months' experience with the remede[reg] Ssystem,'' European Journal
of Heart Failure, pp. 1-8.
\93\ Costanzo, M.R., Ponikowski, P., Javaheri, S., Augostini,
R., Goldberg, L., Holcomb, R., Abraham, W.T., ``Transvenous
Neurostimulation for Centra Sleep Apnoea: A randomised controlled
trial,'' Lacet, 2016, vol. 388, pp. 974-982.
---------------------------------------------------------------------------
According to the applicant, prior to the introduction of the
remed[emacr][supreg] System, typical treatments for CSA took the form
of positive airway pressure devices. Positive airway pressure devices,
such as continuous positive airway pressure (CPAP), have previously
been used to treat patients diagnosed with obstructive sleep apnea.
Positive airway devices deliver constant pressurized air via a mask
worn over the mouth and nose, or nose alone. For this reason, positive
airway devices may only function when the patient wears the necessary
mask. Similar to CPAP, adaptive servo-ventilation (ASV) provides
noninvasive respiratory assistance with expiratory positive airway
pressure. However, ASV adds servo-controlled inspiratory pressure, as
well, in an effort to maintain airway patency.\94\
---------------------------------------------------------------------------
\94\ Cowie, M.R., Woehrle, H., Wegscheider, K., Andergmann, C.,
d'Ortho, M.P., Erdmann, E., Teschler, H., ``Adaptive Servo-
Ventilation for Central Sleep Apneain Systolic Heart Failure,'' N
Eng Jour of Med, 2015, pp. 1-11.
---------------------------------------------------------------------------
On October 6, 2017, the remed[emacr][supreg] System was approved by
the FDA as an implantable phrenic nerve stimulator indicated for the
use in the treatment of adult patients who have been diagnosed with
moderate to severe CSA. The device was available commercially upon FDA
approval. Therefore, the newness period for the remed[emacr][supreg]
System is considered to begin on October 6, 2017. The applicant has
indicated that the device also is designed to restore regular breathing
patterns in the treatment of CSA in patients who also have been
diagnosed with heart failure.
The applicant was approved for two unique ICD-10-PCS procedure
codes for the placement of the leads: 05H33MZ (Insertion of
neurostimulator lead into right innominate (brachiocephalic) vein) and
05H03MZ (Insertion of neurostimulator lead into azygos vein), effective
October 1, 2016. The applicant indicated that implantation of the pulse
generator is currently reported using ICD-10-PCS procedure code 0JH60DZ
(Insertion of multiple array stimulator generator into chest
subcutaneous tissue).
As discussed above, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for the purposes of new technology add-on payments.
As stated in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20309),
with regard to the first criterion, whether a product uses the same or
a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, the remed[emacr][supreg] System provides
stimulation to nerves to stimulate breathing. Typical treatments for
hyperventilation CSA include supplemental oxygen and CPAP. Mechanical
ventilation also has been used to maintain a patent airway. The
applicant asserted that the remed[emacr][supreg] System is a
neurostimulation device resulting in negative airway pressure, whereas
devices such as CPAP and ASV utilize positive airway pressure.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that the
remed[emacr][supreg] System is assigned to MS-DRGs 040 (Peripheral,
Cranial Nerve and Other Nervous System Procedures with MCC), 041
(Peripheral, Cranial Nerve and Other Nervous System Procedures with CC
or Peripheral Neurostimulator), and 042 (Peripheral, Cranial Nerve and
Other Nervous System Procedures without CC/MCC). The current procedures
for the treatment options of CPAP and ASV are not assigned to these MS-
DRGs.
With respect to the third criterion, 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, according to the
applicant, the remed[emacr][supreg] System is indicated for the use as
a transvenous unilateral phrenic nerve stimulator in the treatment of
adult patients who have been diagnosed with moderate to severe CSA. The
applicant stated that the remed[emacr][supreg] System reduces the
negative symptoms associated with CSA, particularly among patients who
have been diagnosed with heart failure. The applicant asserted that
patients who have been diagnosed with heart failure are particularly
negatively affected by CSA and currently available CSA treatment
options of CPAP and ASV. According to the applicant, the currently
available treatment options, CPAP and ASV, have been found to have
worsened mortality and morbidity outcomes for patients who have been
diagnosed with both CSA and heart failure. Specifically, ASV is
currently contraindicated in the treatment of CSA in patients who have
been diagnosed with heart failure.
The applicant also suggested that the remed[emacr][supreg] System
is particularly suited for the treatment of CSA in patients who also
have been diagnosed with heart failure. In the FY 2019 IPPS/LTCH PPS
proposed rule (83 FR 20310), we stated we were concerned that, while
the remed[emacr][supreg] System may be beneficial to patients who have
been diagnosed with both CSA and heart failure, the FDA-approved
indication is for use in the treatment of adult patients who have been
diagnosed with moderate to severe CSA. We noted that the applicant's
clinical analyses and data results related to patients who specifically
were diagnosed with CSA and heart failure. We invited public comments
on whether the remed[emacr][supreg] System meets the newness criterion.
Comment: The applicant stated that the remed[emacr][supreg] System
uses a different mechanism of action because neurostimulation of the
phrenic nerve to treat patients who have been diagnosed with CSA is a
new concept, both, in terms of its mechanism of action and approach.
The applicant explained that utilizing small electrical pulses
delivered to the phrenic nerve via a transvenous lead helps restore a
more normal breathing pattern and indicated that there are no other
FDA-approved CSA therapies that either utilize transvenous
neurostimulation or generate negative pressure to treat patients who
have been diagnosed with CSA.
The applicant explained that currently, cases representing Medicare
patients who have been admitted to the hospital with a diagnosis of CSA
to receive treatment map to a wide array of MS-DRGs. However, the
applicant believed that cases representing patients eligible for
treatment involving the remed[emacr][supreg] System would be assigned
to a different MS-DRG than cases representing patients treated using
standard treatment options, including CPAP or ASV. The applicant
further explained that, based on an analysis of FY 2018 MedPAR data,
claims including a diagnosis of CSA mapped to 458 MS-DRGs with no
single MS-DRG representing more than 4.5 percent of the total claims.
The applicant believed this variant assignment of cases representing
patients who have been diagnosed with CSA and received treatment is
likely due to the fact that
[[Page 41313]]
the vast majority of claims in the MedPAR data included the CSA
diagnosis as a secondary or tertiary diagnosis reported on the claim.
The applicant indicated that cases representing patients receiving
treatment involving the remed[emacr][supreg] System with CSA as a
primary diagnosis would typically be assigned to MS-DRGs 040 or 041.
Several other commenters also supported approval of new technology
add-on payments for the remed[emacr][supreg] System, and asserted that
the neurostimulation of the phrenic nerve is a different mechanism of
action. The commenters indicated that they believed positive airway
pressure (PAP) treatment is inferior to phrenic nerve stimulation
because of patient intolerability, a lack of evidence in support of the
success of PAP treatment in this population, or evidence showing that
PAP such as ASV being contraindicated in the treatment of patients who
have been diagnosed with CSA and heart failure. Another commenter
agreed with the applicant, and stated that the remed[emacr][supreg]
System's mechanism of action to deliver treatment, the neurostimulation
of the phrenic nerve, is a new treatment approach that has never
previously been used.
Response: We appreciate the commenters' support and the applicant's
further analysis and explanation regarding why the remed[emacr][supreg]
System is not substantially similar to other currently available
treatment options, as well as the input provided by the commenters.
Based on review of the comments, we agree that utilization of the
neurostimulation of the phrenic nerve, as performed by the
remed[emacr][supreg] System, is a different mechanism of action and
that cases representing patients receiving treatment involving the use
of the remed[emacr][supreg] System would be assigned to a different MS-
DRG than currently available treatment options. Therefore, we believe
that the remed[emacr][supreg] System is not substantially similar to
any other existing technology. We also note that the applicant provided
additional information regarding patients who have been diagnosed with
CSA, without a diagnosis of heart failure, and we considered this
additional information in our evaluation of the application.
After consideration of the public comments we received, for the
reasons discussed, we believe that the remed[emacr][supreg] System is
not substantially similar to any existing technology and it meets the
newness criterion.
Comment: The applicant stated that the remed[emacr][supreg]
received FDA approval on October 6, 2017. However, the applicant noted
that the first implant procedure was completed on February 01, 2018.
Therefore, the applicant believed that the newness period should begin
on February 01, 2018, rather than the FDA approval date.
Response: As we discuss in section II.H.4. and in our discussion of
Voraxaze included in the FY 2013 IPPS/LTCH PPS final rule (77 FR
53348), generally, our policy is to begin the newness period on the
date of FDA approval or clearance or, if later, the date of
availability of the product on the U.S. market. However, the applicant
did not provide additional information to explain why there was a delay
from the time of FDA approval until the completion of the first implant
procedure to establish a different date of availability. Without
additional information, we continue to believe that the newness period
for the remed[emacr][supreg] System begins on October 6, 2017. We may
consider any further information that may be provided regarding the
date of availability in future rulemaking.
With regard to the cost criterion, the applicant provided the
following analysis to demonstrate that the technology meets the cost
criterion. The applicant identified cases representing potential
patients who may be eligible for treatment involving the
remed[emacr][supreg] System within MS-DRGs 040, 041, and 042. Using the
Standard Analytical File (SAF) Limited Data Set (MedPAR) for FY 2015,
the applicant included all claims for the previously stated MS-DRGs for
its cost threshold calculation. The applicant stated that typically
claims are selected based on specific ICD-10-PCS parameters, however
this is a new technology for which no ICD-10-PCS procedure code and
ICD-10-CM diagnosis code combination exists. Therefore, all claims for
the selected MS-DRGs were included in the cost threshold analysis. This
process resulted in 4,462 cases representing potential patients who may
be eligible for treatment involving the remed[emacr][supreg] System
assigned to MS-DRG 040; 5,309 cases representing potential patients who
may be eligible for treatment involving the remed[emacr][supreg] System
assigned to MS-DRG 041; and 2,178 cases representing potential patients
who may be eligible for treatment involving the remed[emacr][supreg]
System assigned to MS-DRG 042, for a total of 11,949 cases.
Using the 11,949 identified cases, the applicant determined that
the average unstandardized case-weighted charge per case was $85,357.
Using the FY 2015 MedPAR dataset to identify the total mean charges for
revenue code 0278, the applicant removed charges associated with the
current treatment options for each MS-DRG as follows: $9,153.83 for MS-
DRG 040; $12,762.31 for MS-DRG 041; and $21,547.73 for MS-DRG 042. The
applicant anticipated that no other related charges would be eliminated
or replaced. The applicant then standardized the charges and applied a
2-year inflation factor of 1.104055 obtained from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38524). The applicant then added charges for the
new technology to the inflated average case-weighted standardized
charges per case. No other related charges were added to the cases. The
applicant calculated a final inflated average case-weighted
standardized charge per case of $175,329 and a Table 10 average case-
weighted threshold amount of $78,399. Because the final inflated
average case-weighted standardized charge per case exceeded the average
case-weighted threshold amount, the applicant maintained that the
technology met the cost criterion. With regard to the analysis above,
in the proposed rule, we stated that we were concerned that all cases
in MS-DRGs 040, 041, and 042 were used in the analysis. We further
stated that we were unsure if all of these cases represent patients
that may be truly eligible for treatment involving the
remed[emacr][supreg] System. We invited public comments on whether the
remed[emacr][supreg] System meets the cost criterion.
Comment: In response to our concern presented in the FY 2019 IPPS/
LTCH PPS proposed rule, the applicant submitted a revised analysis with
regard to the cost criterion. In its revised cost calculations, the
applicant searched the FY 2016 MedPAR data for cases reporting an ICD-
10-CM procedure code for the insertion of an array stimulator
generator, in combination with a neurostimulator lead. Below is a table
listing the codes searched by the applicant.
------------------------------------------------------------------------
ICD-10-PCS code Description (array stimulator generator)
------------------------------------------------------------------------
0JH60BZ................... INSERTION 1 ARRAY STIM GEN CHEST SUBQ TISS
FASC OPEN.
0JH60CZ................... INSERTION 1 ARRAY RCHG STIM GEN CHST SUBQ
FASCIA OPN.
[[Page 41314]]
0JH60DZ................... INSERTION MX ARRAY STIM GEN CHST SUBQ TISS
FASC OPEN.
0JH60EZ................... INSERTION MX ARRAY RCHG STIM GEN CHST SUBQ
FASC OPEN.
0JH63BZ................... INSERTION 1 ARRAY STIM GEN CHEST SUBQ FASCIA
PERQ.
0JH63CZ................... INSERTION 1 ARRAY RCHG STIM GEN CHST SUBQ
FASC PERQ.
0JH63DZ................... INSERTION MX ARRAY STIM GEN CHEST SUBQ
FASCIA PERQ.
0JH63EZ................... INSERTION MX ARRAY RCHG STIM GEN CHST SUBQ
FASC PERQ.
0JH70BZ................... INSERTION 1 ARRAY STIM GEN BACK SUBQ TISS
FASC OPEN.
0JH70CZ................... INSERTION 1 ARRAY RCHG STIM GEN BACK SUBQ
FASC OPEN.
0JH70DZ................... INSERTION MX ARRAY STIM GEN BACK SUBQ TISS
FASC OPEN.
0JH70EZ................... INSERTION MX ARRAY RCHG STIM GEN BACK SUBQ
FASC OPEN.
0JH73BZ................... INSERTION 1 ARRAY STIM GEN BACK SUBQ TISS
FASC PERQ.
0JH73CZ................... INSERTION 1 ARRAY RCHG STIM GEN BACK SUBQ
FASC PERQ.
0JH73DZ................... INSERTION MX ARRAY STIM GEN BACK SUBQ TISS
FASC PERQ.
0JH73EZ................... INSERTION MX ARRAY RCHG STIM GEN BACK SUBQ
FASC PERQ.
0JH80BZ................... INSERTION 1 ARRAY STIM GEN ABDOMEN SUBQ
FASCIA OPEN.
0JH80CZ................... INSERTION 1 ARRAY RCHG STIM GEN ABDOMN SUBQ
FASC OPN.
0JH80DZ................... INSERTION MX ARRAY STIM GEN ABDOMN SUBQ
FASCIA OPEN.
0JH80EZ................... INSERTION MX ARRAY RCHG STIM GEN ABDMN SUBQ
FASC OPN.
0JH83BZ................... INSERTION 1 ARRAY STIM GEN ABDOMEN SUBQ
FASCIA PERQ.
0JH83CZ................... INSERTION 1 ARRAY RCHRG STIM GEN ABDOMN SUBQ
FASC PC.
0JH83DZ................... INSERTION MX ARRAY STIM GEN ABDOMN SUBQ
FASCIA PERQ.
0JH83EZ................... INSERTION MX ARRAY RCHRG STIM GEN ABDMN SUBQ
FASC PC.
------------------------------------------------------------------------
ICD-10-PCS code Description (neurostimulator lead)
------------------------------------------------------------------------
00HE0MZ................... INSERTION NEURSTIM LEAD CRANIAL NERVE OPEN.
00HE3MZ................... INSERTION NEURSTIMULATOR LEAD CRANIAL NERVE
PERQ.
00HE4MZ................... INSERTION NEURSTIMUL LEAD CRANIAL NERV PERQ
ENDO.
01HY0MZ................... INSERTION NEURSTIM LEAD PERIPHERAL NERVE
OPEN.
01HY3MZ................... INSERTION NEURSTIMULT LEAD PERIPHERAL NERVE
PERQ.
01HY4MZ................... INSERTION NEURSTIM LEAD PERIPH NERVE PERQ
ENDO APPR.
05H00MZ................... INSERTION NEUROSTIMULATOR LEAD IN AZYGOS
VEIN OP.
05H03MZ................... INSERTION NEUROSTIMULATOR LEAD IN AZYGOS
VEIN PQ.
05H04MZ................... INSERTION NEURSTIM LEAD INTO AZYGOS VEIN PQ
ENDO.
05H30MZ................... INSERTION NEUROSTIMULATOR LEAD IN RT INNOMIN
VEIN OPN.
05H33MZ................... INSERTION NEURSTIM LEAD IN RT INNOMIN VEIN
PERQ.
05H34MZ................... INSERTION NEURSTIM LEAD RT INNOMINATE VEIN
PERQ ENDO.
05H40MZ................... INSERTION NEUROSTIMULATOR LEAD LT INNOMIN
VEIN OP.
05H43MZ................... INSERTION NEUROSTIMULATOR LEAD LT INNOMINATE
VEIN PQ.
05H44MZ................... INSERTION NEURSTIM LEAD IN LT INNOMIN VEIN
PQ END.
0DH60MZ................... INSERTION STIMULATOR LEAD STOMACH OPEN
APPROACH.
0DH63MZ................... INSERTION STIMULATOR LEAD STOMACH
PERCUTANEOUS.
0DH64MZ................... INSERTION STIM LEAD STOMACH PERQ ENDO
APPRCH.
------------------------------------------------------------------------
The applicant identified a total of 2,416 cases representing
potential patients who may be eligible for treatment involving the
remed[emacr][supreg] System, with 1,762 cases (72.9 percent of all of
the cases) mapping to MS-DRG 41 and 654 cases (27.1 percent of all of
the cases) mapping to MS-DRG 42, resulting in an average case-weighted
charge per case of $86,744. The applicant removed 100 percent of the
charges associated with the services provided in connection with the
prior technology. The applicant then standardized the charges and
inflated the charges by an inflation factor of 9.36 percent, which
resulted in an inflated average case-weighted standardized charge per
case of $61,426. According to the applicant, the cost of the
remed[emacr][supreg] System is $34,500. The applicant converted the
costs of the technology to charges by dividing the costs by the
national CCR of 0.332 for ``Implantable Devices'' from the FY 2018
IPPS/LTCH PPS final rule. This resulted in $103,916 in estimated
hospital charges for the new technology, which were added to the
inflated standardized charges per case. The final inflated average
case-weighted standardized charge per case is $165,342, which is
$87,877 more than the Table 10 average case-weighted threshold amount
of $77,465. Therefore, the applicant maintained that it meets the cost
criterion.
Response: We appreciate the applicant's submission of revised cost
calculations in response to our concerns.
After consideration of the additional information provided by the
applicant, we agree that the remed[emacr][supreg] System meets the cost
criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the remed[emacr][supreg] System meets the
substantial clinical improvement criterion. The applicant stated that
the remed[emacr][supreg] System offers a treatment option for a patient
population unresponsive to, or ineligible for, treatment involving
currently available options. According to the applicant, patients who
have been diagnosed with CSA have no other available treatment options
than the remed[emacr][supreg] System. The applicant stated that
published studies on both CPAP and ASV have proven that primary
endpoints have not been met for treating patients who have been
diagnosed with CSA. In addition, according to the ASV study, there was
an increase in cardiovascular mortality.
According to the applicant, the remed[emacr][supreg] System will
prove to be a better treatment for the negative effects associated with
CSA in patients who have been diagnosed with heart failure, such as
cardiovascular insults resulting from sympathetic nervous system
[[Page 41315]]
activation, pulmonary hypertension, and arrhythmias, which ultimately
contribute to the downward cycle of heart failure,\95\ when compared to
the currently available treatment options. The applicant also indicated
that prior studies have assessed CPAP and ASV as options for the
treatment of diagnoses of CSA primarily in patients who have been
diagnosed with heart failure.
---------------------------------------------------------------------------
\95\ Abraham, W., Jagielski, D., Oldenburg, O., Augostini, R.,
Kreuger, S., Kolodziej, A., Ponikowski, P., ``Phrenic Nerve
Stimulation for the Treatment of Central Sleep Apnea,'' JACC: Heart
Failure, 2015, vol. 3(5), pp. 360-369.
---------------------------------------------------------------------------
The applicant shared the results from two studies concerning the
effects of positive airway pressure ventilation treatment:
The Canadian Continuous Positive Airway Pressure for
Patients with Central Sleep Apnea and Heart Failure trial found that,
while CPAP managed the negative symptoms of CSA, such as improved
nocturnal oxygenation, increased ejection fraction, lower
norepinephrine levels, and increased walking distance, it did not
affect overall patient survival; \96\ and
---------------------------------------------------------------------------
\96\ Bradley, T.D., Logan, A.G., Kimoff, R.J., Series, F.,
Morrison, D., Ferguson, K., Phil, D., 2005, ``Continous Positive
Airway Pressure for Central Sleep Apnea and Heart Failure,'' N Eng
Jour of Med, vol. 353(19), pp. 2025-2033.
---------------------------------------------------------------------------
In a randomized trial of 1,325 patients who had been
diagnosed with heart failure who received treatment with ASV plus
standard treatment or standard treatment alone, ASV was found to
increase all-cause and cardiovascular mortality as compared to the
control treatment.\97\
---------------------------------------------------------------------------
\97\ Cowie, M.R., Woehrle, H., Wegscheider, K., Andergmann, C.,
d'Ortho, M.-P., Erdmann, E., Teschler, H., ``Adaptive Servo-
Ventilation for Central Sleep Apneain Systolic Heart Failure,'' N
Eng Jour of Med, 2015, pp. 1-11.
---------------------------------------------------------------------------
The applicant also stated that published literature indicates that
currently available treatment options do not meet primary endpoints
with concern to the treatment of CSA; patients treated with ASV
experienced an increased likelihood of mortality,\98\ and patients
treated with CPAP experienced alleviation of symptoms, but no change in
survival.\99\ The applicant provided further research, which suggested
that a primary drawback of CPAP in the treatment of diagnoses of CSA is
a lack of patient adherence to therapy.\100\
---------------------------------------------------------------------------
\98\ Ibid.
\99\ Bradley, T.D., Logan, A.G., Kimoff, R.J., Series, F.,
Morrison, D., Ferguson, K., Phil, D., 2005, ``Continous Positive
Airway Pressure for Central Sleep Apnea and Heart Failure,'' N Engl
Jour of Med, vol. 353(19), pp. 2025-2033.
\100\ Ponikowski, P., Javaheri, S., Michalkiewicz, D., Bart,
B.A., Czarnecka, D., Jastrzebski, M., Abraham, W.T., ``Transvenous
Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnoea
in Heart Failure,'' European Heart Journal, 2012, vol. 33, pp. 889-
894.
---------------------------------------------------------------------------
The applicant also stated that the remed[emacr][supreg] System
represents a substantial clinical improvement over existing
technologies because of the reduction in the number of future
hospitalizations, few device-related complications, and improvement in
CSA symptoms and quality of life. Specifically, the applicant stated
that the clinical data has shown a statistically significant reduction
in Apnea-hypopnea index (AHI), improvement in quality of life, and
significantly improved Minnesota Living with Heart Failure
Questionnaire score. In addition, the applicant indicated that study
results showed the remed[emacr][supreg] System demonstrated an
acceptable safety profile, and there was a trend toward fewer heart
failure hospitalizations.
The applicant provided six published articles as evidence. All six
articles were prospective studies. In three of the six studies, the
majority of patients studied had been diagnosed with CSA with a heart
failure comorbidity, while the remaining three studies only studied
patients who had been diagnosed with CSA with a heart failure
comorbidity. The first study \101\ assessed the treatment of patients
who had been diagnosed with CSA in addition to heart failure. According
to the applicant, as referenced in the results of the published study,
Ponikowski, et al., assessed the treatment effects of 16 of 31 enrolled
patients with evidence of CSA within 6 months prior to enrollment who
met inclusion criteria (apnea-hypopnea index of greater than or equal
to 15 and a central apnea index of greater than or equal to 5) and who
did not meet exclusion criteria (a baseline oxygen saturation of less
than 90 percent, being on supplemental oxygen, having evidence of
phrenic nerve palsy, having had severe chronic obstructive pulmonary
disease (COPD), having hard angina or a myocardial infarction in the
past 3 months, being pacemaker dependent, or having inadequate capture
of the phrenic nerve during neurostimulation). Of the 16 patients whose
treatment was assessed, all had various classifications of heart
failure diagnoses: 3 (18.8 percent) were classified as class I on the
New York Heart Association classification scale (No limitation of
physical activity. Ordinary physical activity does not cause undue
fatigue, palpitation, dyspnea (shortness of breath)); 8 (50 percent)
were classified as a class II (Slight limitation of physical activity.
Comfortable at rest. Ordinary physical activity results in fatigue,
palpitation, dyspnea (shortness of breath)); and 5 (31.3 percent) were
classified as class III (Marked limitation of physical activity.
Comfortable at rest. Less than ordinary activity causes fatigue,
palpitation, or dyspnea).\102\ After successful surgical implantation
of a temporary transvenous lead for unilateral phrenic nerve
stimulation, patients underwent a control night without nerve
stimulation and a therapy night with stimulation, while undergoing
polysomnographic (PSG) testing. Comparison of both nights was
performed.
---------------------------------------------------------------------------
\101\ Ponikowski, P., Javaheri, S., Michalkiewicz, D., Bart,
B.A., Czarnecka, D., Jastrzebski, M., Abraham, W.T., ``Transvenous
Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnoea
in Heart Failure,'' European Heart Journal, 2012, vol. 33, pp. 889-
894.
\102\ American Heart Association: ``Classes of Heart Failure,''
May 8, 2017. Available at: http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#.WmE2rlWnGUk.
---------------------------------------------------------------------------
According to the applicant, some improvements of CSA symptoms were
identified in statistical analyses. Sleep time and efficacy were not
statistically significantly different for control night and therapy
night, with median sleep times of 236 minutes and 245 minutes and sleep
efficacy of 78 percent and 71 percent, respectively. There were no
statistical differences across categorical time spent in each sleep
stage (for example, N1, N2, N3, and REM) between control and therapy
nights. The average respiratory rate and hypopnea index did not differ
statistically across nights. Marginal positive statistical differences
occurred between control and therapy nights for the baseline oxygen
saturation median values (95 and 96 respectively) and obstructive apnea
index (OAI) (1 and 4, respectively). Beneficial statistically
significant differences occurred from control to therapy nights for the
average heart rate (71 to 70, respectively), arousal index events per
hour (32 to 12, respectively), apnea-hypopnea index (AHI) (45 to 23,
respectively), central apnea index (CAI) (27 to 1, respectively), and
oxygen desaturation index of 4 percent (ODI = 4 percent) (31 to 14,
respectively). Two adverse events were noted: (1) Lead tip thrombus
noted when lead was removed; the patient was anticoagulated without
central nervous system sequelae; and (2) an episode of ventricular
tachycardia upon lead placement and before stimulation was initiated.
The episode was successfully treated by defibrillation of the patient's
implanted ICD. Neither adverse event was directly related to the
phrenic nerve stimulation therapy.
[[Page 41316]]
The second study \103\ was a prospective, multi-center,
nonrandomized study that followed patients diagnosed with CSA and other
underlying comorbidities. According to the applicant, as referenced in
the results of the published study, Abraham, et al., 49 of the 57
enrolled patients who were followed indicated a primary endpoint of a
reduction of AHI with secondary endpoints of feasibility and safety of
the therapy. Patients were included if they had an AHI of 20 or greater
and apneic events that were related to CSA. Among the study patient
population, 79 percent had diagnoses of heart failure, 2 percent had
diagnoses of atrial fibrillation, 13 percent had other cardiac etiology
diagnoses, and the remainder of patients had other cardiac unrelated
etiology diagnoses. Exclusion criteria were similar to the previous
study (that is, (Ponikowski P., 2012)), with the addition of a
creatinine of greater than 2.5 mg/dl. After implantation of the
remed[emacr][supreg] System, patients were assessed at baseline, 3
months (n=47) and 6 months (n=44) on relevant measures. At 3 months,
statistically nonsignificant results occurred for the OAI and hypopnea
index (HI) measures. The remainder of the measures showed statistically
significant differences from baseline to 3 months: AHI with a -27.1
episodes per hour of sleep difference; CAI with a -23.4 episodes per
hour of sleep difference; MAI with a -3 episodes per hour of sleep
difference; ODI = 4 percent with a -23.7 difference; arousal index with
-12.5 episodes per hour of sleep difference; sleep efficiency with a
8.4 percent increase; and REM sleep with a 4.5 percent increase.
Similarly, among those assessed at 6 months, statistically significant
improvements on all measures were achieved, including OAI and HI.
Regarding safety, a data safety monitoring board (DSMB) adjudicated and
found the following 3 of 47 patients (6 percent) as having serious
adverse events (SAE) related to the device, implantation procedure or
therapy. None of the DSMB adjudicated SAEs was due to lead
dislodgement. Two SAEs of hematoma or headache were related to the
implantation procedure and occurred as single events in two patients. A
single patient experienced atypical chest discomfort during the first
night of stimulation, but on reinitiation of therapy on the second
night no further discomfort occurred.
---------------------------------------------------------------------------
\103\ Abraham, W., Jagielski, D., Oldenburg, O., Augostini, R.,
Kreuger, S., Kolodziej, A., Ponikowski, P., ``Phrenic Nerve
Stimulation for the Treatment of Central Sleep Apnea,'' JACC: Heart
Failure, 2015, vol. 3(5), pp. 360-369.
---------------------------------------------------------------------------
The third study \104\ assessed the safety and feasibility of
phrenic nerve stimulation for 6 monthly follow-ups of 8 patients
diagnosed with heart failure with CSA. Of the eight patients assessed,
one was lost to follow-up and one died from pneumonia. According to the
applicant, as referenced in the results in the published study, Zheng,
et al. (2015), no unanticipated serious adverse events were found to be
related to the therapy; in one patient, a lead became dislodged and
subsequently successfully repositioned. Three patients reported
improved sleep quality, and all patients reported increased energy. A
reduction in sleep apneic events and decreases in AHI and CAI were
related to application of the treatment. Gradual increases to the 6-
minute walking time occurred through the study.
---------------------------------------------------------------------------
\104\ Zhang, X., Ding, N., Ni, B., Yang, B., Wang, H., & Zhang,
S.J., ``Satefy and Feasibility of Chronic Transvenous Phrenic Nerve
Stimulation for Treatment of Central Sleep Apnea in Heart Failure
Patients,'' The Clinical Respiratory Journal, 2015, pp. 1-9.
---------------------------------------------------------------------------
The fourth study \105\ extended the previous Phase I study \106\
from 6 months to 12 months, and included only 41 of the original 49
patients continuing in the study. Of the 57 patients enrolled at the
time of the Phase I study, 41 were evaluated at the 12-month follow-up.
Of the 41 patients examined at 12 months, 78 percent had diagnoses of
CSA related to heart failure, 2 percent had diagnoses of atrial
fibrillation with related CSA, 12 percent had diagnoses of CSA related
to other cardiac etiology diagnoses, and the remainder of patients had
diagnoses of CSA related to other noncardiac etiology diagnoses. At 12
months, 6 sleep parameters remained statistically different and 3 were
no longer statistically significant. The HI, OAI, and arousal indexes
were no longer statistically significantly different from baseline
values. A new parameter, time spent with peripheral capillary oxygen
saturation (SpO2) below 90 percent was not statistically different at
12 months (31.4 minutes) compared to baseline (38.2 minutes). The
remaining 6 parameters showed maintenance of improvements at the 12-
month time point as compared to the baseline: AHI from 49.9 to 27.5
events per hour; CAI from 28.2 to 6.0 events per hour; MAI from 3.0 to
0.5 events per hour; ODI = 4 percent from 46.1 to 26.9 events per hour;
sleep efficiency from 69.3 percent to 75.6 percent; and REM sleep from
11.4 percent to 17.1 percent. At the 3-month, 6-month, and 12-month
time points, patient quality of life was assessed to be 70.8 percent,
75.6 percent, and 83.0 percent, respectively, indicating that patients
experienced mild, moderate, or marked improvement. Seventeen patients
were followed at 18 months with statistical differences from baseline
for AHI and CAI. Three patients died over the 12-month follow-up
period: 2 Died of end-stage heart failure and 1 died from sudden
cardiac death. All three deaths were adjudicated by the DSMB and none
were related to the procedure or to phrenic nerve stimulation therapy.
Five patients were found to have related serious adverse events over
the 12-month study time. Three events were previously described in the
results referenced in the published study, Abraham, et al., and an
additional 2 SAEs occurred during the 12-month follow-up. One patient
experienced impending pocket perforation resulting in pocket revision,
and another patient experienced lead failure.
---------------------------------------------------------------------------
\105\ Jagielski, D., Ponikowski, P., Augostini, R., Kolodziej,
A., Khayat, R., & Abraham, W.T., ``Transvenous Stimulation of the
Phrenic Nerve for the Treatment of Central Sleep Apnoea: 12 months'
experience with the remede[supreg]system,'' European Journal of
Heart Failure, 2016, pp. 1-8.
\106\ Abraham, W., Jagielski, D., Oldenburg, O., Augostini, R.,
Kreuger, S., Kolodziej, A., Ponikowski, P., 2015, ``Phrenic Nerve
Stimulation for the Treatment of Central Sleep Apnea,'' JACC: Heart
Failure, 2015, vol. 3(5), pp. 360-369.
---------------------------------------------------------------------------
The fifth study \107\ was a randomized control trial with a primary
outcome of achieving a reduction in AHI of 50 percent or greater from
baseline to 6 months enrolling 151 patients with the neurostimulation
treatment (n=73) and no stimulation control (n=78). Of the total
sample, 96 (64 percent) of the patients had been diagnosed with heart
failure; 48 (66 percent) of the treated patients had been diagnosed
with heart failure, and 48 (62 percent) of the control patients had
been diagnosed with heart failure. Sixty-four (42 percent) of all of
the patients included in the study had been diagnosed with atrial
fibrillation and 84 (56 percent) had been diagnosed with coronary
artery disease. All of the patients had been treated with the
remed[emacr][supreg] System device implanted; the system was activated
in the treatment group during the first month. ``Over about 12 weeks,
stimulation was gradually increased in the treatment group until
diaphragmatic capture was consistently achieved without disrupting
sleep.'' \108\ While patients and physicians were unblinded, the
polysomnography core laboratory remained blinded. The per-
[[Page 41317]]
protocol population from which statistical comparisons were made is 58
patients treated with the remed[emacr][supreg] System and 73 patients
in the control group. The authors appropriately controlled for Type I
errors (false positives), which arise from performing multiple tests.
Thirty-five treated patients and 8 control patients met the primary end
point, the number of patients with a 50 percent or greater reduction in
AHI from baseline; the difference of 41 percent is statistically
significant. All seven of the secondary endpoints were assessed and
found to have statistically significant difference in change from
baseline between groups at the 6-month follow-up after controlling for
multiple comparisons: CAI of -22.8 events per hour lower for the
treatment group; AHI (continuous) of -25.0 events per hour lower for
the treatment group; arousal events per hour of -15.2 lower for the
treatment group; percent of sleep in REM of 2.4 percent higher for the
treatment group; patients with marked or moderate improvement in
patient global assessment was 55 percent higher in the treatment group;
ODI = 4 percent was -22.7 events per hour lower for the treatment
group; and the Epworth sleepiness scale was -3.7 lower for the
treatment group. At 12 months, 138 (91 percent) of the patients were
free from device, implant, and therapy related adverse events.
---------------------------------------------------------------------------
\107\ Costanzo, M.R., Ponikowski, P., Javaheri, S., Augostini,
R., Goldberg, L., Holcomb, R., Abraham, W.T.,''Transvenous
Neurostimulation for Centra Sleep Apnoea: A randomised controlled
trial,'' Lacet, 2016, vol. 388, pp. 974-982.
\108\ Ibid.
---------------------------------------------------------------------------
The final study data was from the pivotal study with limited
information in the form of an abstract \109\ and an executive
summary.\110\ The executive summary detailed an exploratory analysis of
the 141 patients enrolled in the pivotal trial which were patients
diagnosed with CSA. The abstract indicated that the 141 patients from
the pivotal trial were randomized to either the treatment arm (68
patients) in which initiation of treatment began 1 month after
implantation of the remed[emacr][supreg] System device with a 6-month
follow-up period, or to the control group arm (73 patients) in which
the initiation of treatment with the remed[emacr][supreg] System device
was delayed for 6 months after implantation. Randomization efficacy was
compared across baseline polysomnography and associated respiratory
indices in which four of the five measures showed no statistical
differences between those treated and controls; treated patients had an
average MAI score of 3.1 as compared to control patients with an
average MAI score of 2.2 (p=0.029). Patients included in the trial must
have been medically stable, at least 18 years old, have had an
electroencephalogram within 40 days of scheduled implantation, had an
apnoea-hypopnoea index (AHI) of 20 events per hour or greater, a
central apnoea index at least 50 percent of all apneas, and an
obstructive apnea index less than or equal to 20 percent.\111\ Primary
exclusion criteria were CSA caused by pain medication, heart failure of
state D from the American Heart Association, a new implantable
cardioverter defibrillator, pacemaker dependent subjects without any
physiologic escape rhythm, evidence of phrenic nerve palsy, documented
history of psychosis or severe bipolar disorder, a cerebrovascular
accident within 12 months of baseline testing, limited pulmonary
function, baseline oxygen saturation less than 92 percent while awake
and on room air, active infection, need for renal dialysis, or poor
liver function.\112\ Patients included in this trial were primarily
male (89 percent), white (95 percent), with at least one comorbidity
with cardiovascular conditions being most prevalent (heart failure at
64 percent), with a concomitant implantable cardiovascular stimulation
device in 42 percent of patients at baseline. The applicant stated
that, after randomization, there were no statistically significant
differences between the treatment and control groups, with the
exception of the treated group having a statistically higher rate of
events per hour on the mixed apnea index (MAI) at baseline than the
control group.
---------------------------------------------------------------------------
\109\ Goldberg, L., Ponikowski, P., Javaheri, S., Augostini, R.,
McKane, S., Holcomb, R., Costanzo, M.R., ``In Heart Failure Patients
with Central Sleep Apnea, Transvenous Stimulation of the Phrenic
Nerve Improves Sleep and Quality of Life,'' Heart Failure Society of
America, 21st annual meeting. 2017.
\110\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
\111\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
\112\ Ibid.
---------------------------------------------------------------------------
The applicant asserted that the results from the pivotal trial
\113\ allow for the comparison of heart failure status in patients; we
note that patients with American Heart Association objective assessment
Class D (Objective evidence of severe cardiovascular disease. Severe
limitations. Experiences symptoms even while at rest) were excluded
from this pivotal trial. The primary endpoint in the pivotal trial was
the proportion of patients with an AHI reduction greater than or equal
to 50 percent at 6 months. When controlling for heart failure status,
both treated groups experienced a statistically greater proportion of
patients with AHI reductions than the controls at 6 months (58 percent
more of treated patients with diagnoses of heart failure and 35 percent
more of treated patients without diagnoses of heart failure as compared
to their respective controls). The secondary endpoints assessed were
the CAI average events per hour, AHI average events per hour, arousal
index (ArI) average events per hour, percent of sleep in REM, and
oxygen desaturation index 4 percent (ODI = 4 percent) average events
per hour. Excluding the percent of sleep in REM, the treatment groups
for both patients with diagnoses of heart failure and non-heart failure
conditions experienced statistically greater improvements at 6 months
on all secondary endpoints as compared to their respective controls.
Lastly, quality of life secondary endpoints were assessed by the
Epworth sleepiness scale (ESS) average scores and the patient global
assessment (PGA). For both the ESS and PGA assessments, both treatment
groups of patients with diagnoses of heart failure and non-heart
failure conditions had statistically beneficial changes between
baseline and 6 months as compared to their respective control groups.
---------------------------------------------------------------------------
\113\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
---------------------------------------------------------------------------
The applicant provided analyses from the above report focusing on
the primary and secondary polysomnography endpoints, specifically,
across patients who had been diagnosed with CSA with heart failure and
non-heart failure. Eighty patients included in the study from the
executive summary report had comorbid heart failure, while 51 patients
did not. Of those patients with heart failure, 35 were treated while 45
patients were controls. Of those patients without heart failure, 23
were treated and 28 patients were controls. The applicant did not
provide baseline descriptive statistical comparisons between treated
and control groups controlling for heart failure status. Across all
primary and secondary endpoints, the patient group who were diagnosed
with CSA and comorbid heart failure experienced statistically
significant improvements. Excepting percent of sleep in REM, the
patient group who were diagnosed with CSA without comorbid heart
failure experienced statistically significant improvements in all
primary and secondary endpoints. In the FY 2019 IPPS/LTCH PPS proposed
rule, we invited public comments on whether this current study design
is sufficient to support substantial clinical improvement of the
remed[emacr][supreg] System with respect to all patient populations,
[[Page 41318]]
particularly the non-heart failure population.
As previously noted, the applicant also contends that the
technology offers a treatment option for a patient population
unresponsive to, or ineligible for, currently available treatment
options. Specifically, the applicant stated that the
remed[emacr][supreg] System is the only treatment option for patients
who have been diagnosed with moderate to severe CSA; published studies
on positive pressure treatments like CPAP and ASV have not met primary
endpoints; and there was an increase in cardiovascular mortality
according to the ASV study. According to the applicant, approximately
40 percent of patients who have been diagnosed with CSA have heart
failure. The applicant asserted that the use of the
remed[emacr][supreg] System not only treats and improves the symptoms
of CSA, but there is evidence of reverse remodeling in patients with
reduced left ventricular ejection fraction (LVEF).
In the proposed rule we stated we were concerned that the
remed[emacr][supreg] System is not directly compared to the CPAP or ASV
treatment options, which, to our understanding, are the current
treatment options available for patients who have been diagnosed with
CSA without heart failure. We noted that the FDA-approved indication
for the implantation of the remed[emacr][supreg] System is for use in
the treatment of adult patients who have been diagnosed with moderate
to severe CSA. We also noted that the applicant's supporting studies
were directed primarily at patients who had been treated with the
remed[emacr][supreg] System who also had been diagnosed with heart
failure. The applicant asserted that it would not be appropriate to use
CPAP and ASV treatment options when comparing CPAP and ASV to the
remed[emacr][supreg] System in the patient population of heart failure
diagnoses because these treatment options have been found to increase
mortality outcomes in this population. In light of the limited length
of time in which the remed[emacr][supreg] System has been studied, we
indicated we were concerned that any claims on mortality as they relate
to treatment involving the use of the remed[emacr][supreg] System may
be limited. Therefore, we were concerned as to whether there is
sufficient data to determine that the technology represents a
substantial clinical improvement with respect to patients who have been
diagnosed with CSA without heart failure.
We stated in the proposed rule that the applicant has shown that,
among the subpopulation of patients who have been diagnosed with CSA
and heart failure, the remed[emacr][supreg] System decreases morbidity
outcomes as compared to the CPAP and ASV treatment options. In the
proposed rule, we noted that we understood that not all patients
evaluated in the applicant's supporting clinical trials had been
diagnosed with CSA with a comorbidity of heart failure. However, in all
of the supporting studies for this application, the vast majority of
study patients did have this specific comorbidity of CSA and heart
failure. Of the three studies which enrolled both patients diagnosed
with CSA with and without heart failure,114 115 116 117 only
two studies performed analyses controlling for heart failure
status.118 119 The data from these two studies, the
Costanzo, et al. (2016) and the Respicardia, Inc. executive report, are
analyses based on the same pivotal trial data and, therefore, do not
provide results from two separate samples. Descriptive comparisons are
made in the executive summary of the pivotal trial \120\ between all
treated and control patients. However, we were unable to determine the
similarities and differences between patients with heart failure and
non-heart failure treated versus controlled groups. Because
randomization resulted in one difference between the overall treated
and control groups (MAI events per hour), we stated that it is possible
that further failures of randomization may have occurred when
controlling for heart failure status in unmeasured variables. Finally,
the sample size analyzed and the subsample sizes of the heart failure
patients (80) and non-heart failure patients (51) are particularly
small. We stated that it is possible that these results are not
representative of the larger population of patients who have been
diagnosed with CSA.
---------------------------------------------------------------------------
\114\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
\115\ Costanzo, M.R., Ponikowski, P., Javaheri, S., Augostini,
R., Goldberg, L., Holcomb, R., Abraham, W.T., ``Transvenous
Neurostimulation for Centra Sleep Apnoea: A randomised controlled
trial,'' Lacet, 2016, vol. 388, pp. 974-982.
\116\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
\117\ Jagielski, D., Ponikowski, P., Augostini, R., Kolodziej,
A., Khayat, R., & Abraham, W.T., ``Transvenous Stimulation of the
Phrenic Nerve for the Treatment of Central Sleep Apnoea: 12 months'
experience with the remede[supreg]system,'' European Journal of
Heart Failure, 2016, pp. 1-8.
\118\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
\119\ Costanzo, M.R., Ponikowski, P., Javaheri, S., Augostini,
R., Goldberg, L., Holcomb, R., Abraham, W.T., ``Transvenous
Neurostimulation for Centra Sleep Apnoea: A randomised controlled
trial,'' Lacet, 2016, vol. 388, pp. 974-982.
\120\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
---------------------------------------------------------------------------
Therefore, in the proposed rule we stated we were concerned that
differences in morbidity and mortality outcomes between CPAP, ASV, and
the remed[emacr][supreg] System in the general CSA patient population
have not adequately been tested or compared. Specifically, the two
patient populations, those who have been diagnosed with heart failure
and CSA versus those who have been diagnosed with CSA alone, may
experience different symptoms and outcomes associated with their
disease processes. Patients who have been diagnosed with CSA alone
present with excessive sleepiness, poor sleep quality, insomnia, poor
concentration, and inattention.\121\ Conversely, patients who have been
diagnosed with the comorbid conditions of CSA as a result of heart
failure experience significant cardiovascular insults resulting from
sympathetic nervous system activation, pulmonary hypertension, and
arrhythmias, which ultimately contribute to the downward cycle of heart
failure.\122\
---------------------------------------------------------------------------
\121\ Badr, M.S., 2017, Dec 11, ``Central sleep apnea: Risk
factors, clinical presentation, and diagnosis,'' Available at:
https://www.uptodate.com/contents/central-sleep-apnea-risk-factors-clinical-presentation-and-diagnosis?csi=d3a535e6-1cca-4cd5-ab5e-50e9847bda6c&source=contentShare.
\122\ Abraham, W., Jagielski, D., Oldenburg, O., Augostini, R.,
Kreuger, S., Kolodziej, A., Ponikowski, P., ``Phrenic Nerve
Stimulation for the Treatment of Central Sleep Apnea,'' JACC: Heart
Failure, 2015, vol. 3(5), pp. 360-369.
---------------------------------------------------------------------------
We also noted that the clinical study had a small patient
population (n=151), with follow-up for 6 months. We stated that we were
interested in longer follow-up data that would further validate the
points made by the applicant regarding the beneficial outcomes seen in
patients who have been diagnosed with CSA who have been treated using
the remed[emacr][supreg] System. We also expressed interest in
additional information regarding the possibility of electrical
stimulation of unintended targets and devices combined with the
possibility of interference from outside devices. Furthermore, we
stated that we were unsure with regard to the longevity of the
implanted device, batteries, and leads because it appears that the
technology is meant to remain in use for the remainder of a patient's
life. We invited public comments on whether the remed[emacr][supreg]
System represents a substantial clinical improvement over existing
technologies.
Comment: The applicant provided responses to CMS' substantial
clinical improvement concerns presented in the FY 2019 IPPS/LTCH PPS
proposed rule
[[Page 41319]]
regarding the use of the remed[emacr][supreg] System. With regard to
CMS' concern that the clinical studies of the remed[emacr][supreg]
System did not include comparisons to PAP treatments, which are
available treatment options for non-heart failure patients who have
been diagnosed with CSA, the applicant stated that the following are
several reasons for not using PAP treatments as comparators in their
clinical trials:
Other clinical trials, such as the CANPAP and SERVE-HF,
which used PAP treatments in the course of treating patients who had
been diagnosed with CSA were halted early due to the possibility of
increased mortality;
There exists little evidence showing that PAP treatments
are effective for treatment of non-heart failure patients who have been
diagnosed with CSA, according to the AASM; and
Prior to the development of the remed[emacr][supreg]
System's pivotal trial, there was a lack of prospective, randomized
data showing a relationship between PAP treatments and morbidity
outcomes.
The applicant also believed that positive airway pressure devices
were more likely to be considered for use in the treatment of patients
who have been diagnosed with CSA, but without a diagnosis of heart
failure. Another commenter stated that it agreed with the applicant's
reasons and supported the rationale for not using PAP treatments as
comparators in its clinical trials.
With regard to CMS' concern that claims related to mortality
following treatment with the remed[emacr][supreg] System are limited,
the applicant agreed with CMS' assessment and stated that limited
research on the system's impact on mortality for patients who have been
diagnosed with CSA has been completed. The applicant further noted that
mortality information was collected primarily for safety purposes
during the pivotal trial. Another commenter also agreed with CMS' and
the applicant's assessment and reiterated the applicant's statements.
The applicant addressed CMS' concern that the FDA-approved
indication for the remed[emacr][supreg] System is for all patients
diagnosed with moderate to severe CSA and not specifically those
diagnosed with a heart failure comorbidity. The applicant stated that
the data from the pivotal trial provided evidence that the use of the
remed[emacr][supreg] System as a treatment option is safe and effective
for patients who have been diagnosed with CSA, regardless of a heart
failure comorbidity. Another commenter agreed with the applicant and
stated that the data from the pivotal trial supported the applicant's
response regarding the concern of the FDA-approved indication.
Regarding the concern that baseline statistical comparisons between
treatment groups were not provided controlling for heart failure
status, the applicant stated that there were no significant differences
in baseline CSA disease burden between the treatment and control
groups. The applicant further stated that, as expected, the heart
failure and non-heart failure groups differed slightly by age and
cardiac (for example, atrial fibrillation and hypertension) and other
comorbidities (for example, hospitalizations within the last 12 months,
diabetes, renal disease, depression).
In regard to the results at 6 and 12 months, the applicant stated
that in all categories, except for quality of life, both the heart
failure and non-heart failure groups showed statistically significant
improvements from the baseline. The applicant asserted that for quality
of life, which did not have a baseline, both groups had greater than 50
percent of respondents, which demonstrates marked or moderate
improvement to their quality of life with a higher proportion in the
non-heart failure group as compared to the heart failure group. Another
commenter added that given the overall consistent balance achieved
between the treatment and control groups across the many baseline
variables examined, there is no evidence suggesting noteworthy
imbalances to be expected in these subgroups.
The applicant addressed CMS' concerns related to the differences
between heart failure and non-heart failure patients who received
treatment with the remed[emacr][supreg] System. The applicant asserted
that it is well established that a significant proportion of patients
who have been diagnosed with CSA have a heart failure comorbidity; 64
percent of patients enrolled in the pivotal trial had a diagnosis of
heart failure. The applicant stated that it expected a higher
proportion of heart failure patients enrolled in the study of CSA due
to the correlated incidence of these diseases and the pivotal trial
inclusion criteria being based on conventional sleep apnea metrics and
not comorbidities. The applicant further stated that, regardless of the
patients' comorbidity status, patients experienced consistent and
durable improvements with the use of the remed[emacr][supreg] System as
a treatment option.
The applicant responded to CMS' concern regarding the small sample
size used for the pivotal trial. The applicant stated that the sample
size was chosen with an alpha error of 0.025, a power of 80 percent, an
expected 50 percent response rate in the treatment group, and a 25
percent response rate in the control group. The applicant further
stated that the study accounted for a 15 percent implantation failure
and a 10 percent drop-out rate. The applicant indicated that,
ultimately, the trial randomized 151 patients, with 147 successful
implantations. Another commenter stated that the results showing highly
statistical significance were derived from a sample size of patients
across 31 different places around the world and, therefore, are
generalizable.
The applicant responded to CMS' interest in longer term follow-up
data. The applicant stated that 12-month follow-up data was recently
published providing 12 months of treatment data for patients enrolled
in the treated group and 6 months of treatment data for patients
enrolled in the control group. Other commenters stated that 12-month
follow-up data results are available and show continued durability of
6-month results.
The applicant addressed CMS' concern about the potential for
electrical stimulation of unintended targets and interference from
outside devices. The applicant stated that 42 percent of the patients
involved in the pivotal trial had a concomitant cardiac device. The
applicant stated that interactions between devices are not unique to
the remed[emacr][supreg] System and that only three serious device
interactions were reported, all of which were resolved with
reprogramming. The applicant further indicated that, all except 1 of
the 21 extra-respiratory stimulation cases that occurred were resolved
with routine reprogramming of the remed[emacr][supreg] System, the
other required repositioning of the lead. Ultimately, 96 percent of the
patients enrolled in the pivotal trial would elect to have the medical
procedure again.
Lastly, the applicant addressed CMS' concern about longevity of the
implanted device, batteries, and leads. The applicant stated that the
expected typical battery life is 41 months, which is consistent with
other implanted neurostimulation devices. The applicant further stated
that the leads were FDA pre-market approved and designed based on
predicate, permanent cardiac pacing leads for which the standards are
more rigorous than those for neurostimulation. The applicant indicated
that, the leads, therefore, compare favorably to leads used for
neurostimulation in categories such as lead breakage, connector
failure, lead dislodgement, and infection.
[[Page 41320]]
Another commenter responded to CMS' concern about the possible
failure in randomization when controlling for heart failure status. The
commenter stated that it does not consider the reported baseline
difference as a failure of randomization. The commenter further noted
that, of the approximately 50 baseline factors examined and reported in
the clinical study report from the pivotal trial, only MAI had a p-
value equal to less than 0.05 associated with a study group difference.
Many commenters stated that the remed[emacr][supreg] System
represented a substantial clinical improvement and referenced clinical
data, in general, and others specifically mentioned the pivotal trial
results as demonstration of the improved benefit over existing
treatment options. These commenters also noted that the use of the
remed[emacr][supreg] System and the mechanism of action of phrenic
nerve stimulation showed sustained benefits for patients who have been
diagnosed with CSA and received treatment using the system.
Response: We appreciate the thoroughness of the additional
information and analyses provided by the applicant and commenters in
response to our concerns regarding whether the technology meets the
substantial clinical improvement criterion. We agree with the applicant
and commenters that the use of the remed[emacr][supreg] System
represents a substantial clinical improvement over existing
technologies because, based on the information provided by the
applicant, it substantially improves relevant metrics related to the
CSA condition, regardless of whether there is the presence of heart
failure comorbidities. Specifically, the applicant provided data which
demonstrated the effectiveness of the remed[emacr][supreg] System for
the treatment of moderate and severe CSA in all treated patients,
regardless of a heart failure comorbidity. Patients without a diagnosis
of heart failure benefited from treatment involving the
remed[emacr][supreg] System, as well as those with a diagnosis of heart
failure. Furthermore, the applicant and commenters provided evidence to
allay our concerns as they related to a lack of use of CPAP as a
comparator for the remed[emacr][supreg] System in clinical trials,
baseline data regarding differences between heart failure and non-heart
failure groups, a small sample size in the pivotal trial, longer term
follow-up data, the potential for interplay between concomitant
devices, and the longevity of the device, batteries, and leads.
After consideration of the public comments we received, we have
determined that the remed[emacr][supreg] System meets all of the
criteria for approval for new technology add-on payments. Therefore, we
are approving new technology add-on payments for the
remed[emacr][supreg] System for FY 2019. Cases involving the use of the
remed[emacr][supreg] System that are eligible for new technology add-on
payments will be identified by ICD-10-PCS procedures codes 0JH60DZ and
05H33MZ in combination with procedure code 05H03MZ (Insertion of
neurostimulator lead into right innominate vein, percutaneous approach)
or 05H043MZ (Insertion of neurostimulator lead into left innominate
vein, percutaneous approach).
In its application, the applicant estimated that the average
Medicare beneficiary would require the surgical implantation of one
remed[emacr][supreg] System per patient. According to the application,
the cost of the remed[emacr][supreg] System is $34,500 per patient.
Under Sec. 412.88(a)(2), we limit new technology add-on payments 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 a case involving
the use of the remed[emacr][supreg] System is $17,250 for FY 2019. In
accordance with the current indication for the use of the
remed[emacr][supreg] System, CMS expects that the remed[emacr][supreg]
System will be used for the treatment of adult patients who have been
diagnosed with moderate to severe CSA.
e. Titan Spine nanoLOCK[supreg] (Titan Spine nanoLOCK[supreg] Interbody
Device)
Titan Spine submitted an application for new technology add-on
payments for the Titan Spine nanoLOCK[supreg] Interbody Device (the
Titan Spine nanoLOCK[supreg]) for FY 2019. (We note that the applicant
previously submitted an application for new technology add-on payments
for this device for FY 2017.) The Titan Spine nanoLOCK[supreg] is a
nanotechnology-based interbody medical device with a dual acid-etched
titanium interbody system used to treat patients diagnosed with
degenerative disc disease (DDD). One of the key distinguishing features
of the device is the surface manufacturing technique and materials,
which produce macro, micro, and nano-surface textures. According to the
applicant, the combination of surface topographies enables initial
implant fixation, mimics an osteoclastic pit for bone growth, and
produces the nano-scale features that interface with the integrins on
the outside of the cellular membrane. Further, the applicant noted that
these features generate better osteogenic and angiogenic responses that
enhance bone growth, fusion, and stability. The applicant asserted that
the Titan Spine nanoLOCK[supreg]'s clinical features also reduce pain,
improve recovery time, and produce lower rates of device complications
such as debris and inflammation.
On October 27, 2014, the Titan Spine nanoLOCK[supreg] received FDA
clearance for the use of five lumbar interbody devices and one cervical
interbody device: The nanoLOCK[supreg] TA--Sterile Packaged Lumbar ALIF
Interbody Fusion Device with nanoLOCK[supreg] surface, available in
multiple sizes to accommodate anatomy; the nanoLOCK[supreg] TAS--
Sterile Packaged Lumbar ALIF Stand Alone Interbody Fusion Device with
nanoLOCK[supreg] surface, available in multiple sizes to accommodate
anatomy; the nanoLOCK[supreg] TL--Sterile Packaged Lumbar Lateral
Approach Interbody Fusion Device with nanoLOCK[supreg] surface,
available in multiple sizes to accommodate anatomy; the
nanoLOCK[supreg] TO--Sterile Packaged Lumbar Oblique/PLIF Approach
Interbody Fusion Device with nanoLOCK[supreg] surface, available in
multiple sizes to accommodate anatomy; the nanoLOCK[supreg] TT--Sterile
Packaged Lumbar TLIF Interbody Fusion Device with nanoLOCK[supreg]
surface, available in multiple sizes to accommodate anatomy; and the
nanoLOCK[supreg] TC--Sterile Packaged Cervical Interbody Fusion Device
with nanoLOCK[supreg] surface, available in multiple sizes to
accommodate anatomy.
The applicant received FDA clearance on December 14, 2015, for the
nanoLOCK[supreg] TCS--Sterile Package Cervical Stand Alone Interbody
Fusion Device with nanoLOCK[supreg] surface, available in multiple
sizes to accommodate anatomy. According to the applicant, July 8, 2016,
was the first date that the nanotechnology production facility
completed validations and clearances needed to manufacture the
nanoLOCK[supreg] interbody fusion devices. Once validations and
clearances were completed, the technology was available on the U.S.
market on October 1, 2016. Therefore, the applicant believes that the
newness period for nanoLOCK[supreg] would begin on October 1, 2016.
Procedures involving the Titan Spine nanoLOCK[supreg] technology can be
identified by the following ICD-10-PCS Section ``X'' New Technology
codes:
XRG0092 (Fusion of occipital-cervical joint using
nanotextured surface interbody fusion device, open approach);
[[Page 41321]]
XRG1092 (Fusion of cervical vertebral joint using
nanotextured surface interbody fusion device, open approach);
XRG2092 (Fusion of 2 or more cervical vertebral joints
using nanotextured surface interbody fusion device, open approach);
XRG4092 (Fusion of cervicothoracic vertebral joint using
nanotextured surface interbody fusion device, open approach);
XRG6092 (Fusion of thoracic vertebral joint using
nanotextured surface interbody fusion device, open approach);
XRG7092 (Fusion of 2 to 7 thoracic vertebral joints using
nanotextured surface interbody fusion device, open approach);
XRG8092 (Fusion of 8 or more thoracic vertebral joints
using nanotextured surface interbody fusion device, open approach);
XRGA092 (Fusion of thoracolumbar vertebral joint using
nanotextured surface interbody fusion device, open approach);
XRGB092 (Fusion of lumbar vertebral joint using
nanotextured surface interbody fusion device, open approach);
XRGC092 (Fusion of 2 or more lumbar vertebral joints using
nanotextured surface interbody fusion device, open approach); and
XRGD092 (Fusion of lumbosacral joint using nanotextured
surface interbody fusion device, open approach).
We note that the applicant expressed concern that interbody fusion
devices that have failed to gain or apply for FDA clearance with
nanoscale features could confuse health care providers with marketing
and advertising using terms related to nanotechnology and ultimately
adversely affect patient outcomes.
As discussed previously, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for the purposes of new technology add-on payments. In the proposed
rule we noted that the substantial similarity discussion is applicable
to both the lumbar and the cervical interbody devices because all of
the devices use the Titan Spine nanoLOCK[supreg] technology.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant stated that, for both interbody devices (the lumbar and the
cervical interbody device), the Titan Spine nanoLOCK[supreg]'s surface
stimulates osteogenic cellular response to assist in bone formation
during fusion. According to the applicant, the mechanism of action
exhibited by the Titan Spine's nanoLOCK[supreg] surface technology
involves the ability to create surface features that are meaningful to
cellular regeneration at the nano-scale level. During the manufacturing
process, the surface produces macro, micro, and nano-surface textures.
The applicant believed that this unique combination and use of these
surface topographies represents a new approach to stimulating
osteogenic cellular response. The applicant further asserted that the
macro-scale textured features are important for initial implant
fixation; the micro-scale textured features mimic an osteoclastic pit
for supporting bone growth; and the nano-scale textured features
interface with the integrins on the outside of the cellular membrane,
which generates the osteogenic and angiogenic (mRNA) responses
necessary to promote healthy bone growth and fusion. The applicant
stated that when correctly manufactured, an interbody fusion device
includes a hierarchy of complex surface features, visible at different
levels of magnification, that work collectively to impact cellular
response through mechanical, cellular, and biochemical properties. The
applicant stated that Titan Spine's proprietary and unique surface
technology, the Titan Spine nanoLOCK[supreg] interbody devices, contain
optimized nano surface characteristics, which generate the distinct
cellular responses necessary for improved bone growth, fusion, and
stability. The applicant further stated that the Titan Spine
nanoLOCK[supreg]'s surface engages with the strongest portion of the
vertebral endplate, which enables better resistance to subsidence
because a unique dual acid-etched titanium surface promotes earlier
bone in-growth. According to the applicant, the Titan Spine
nanoLOCK[supreg]'s surface is created by using a reductive process of
the titanium itself. The applicant asserted that use of the Titan Spine
nanoLOCK[supreg] significantly reduces the potential for debris
generated during impaction when compared to treatments using
Polyetheretherketone (PEEK)-based implants coated with titanium.
According to the results of an in vitro study (provided by the
applicant), which examined factors produced by human mesenchymal stem
cells on spine implant materials that compared angiogenic factor
production using PEEK-based versus titanium alloy surfaces, osteogenic
production levels were greater with the use of rough titanium alloy
surfaces than the levels produced using smooth titanium alloy surfaces.
Human mesenchymal stem cells were cultured on tissue culture
polystyrene, PEEK, smooth TiAlV, or macro-/micro-/nanotextured rough
TiAlV (mmnTiAlV) disks. Osteoblastic differentiation and secreted
inflammatory interleukins were assessed after 7 days. The results of an
additional study provided by the applicant examined whether
inflammatory microenvironment generated by cells as a result of use of
titanium aluminum-vanadium (Ti-alloy, TiAlV) surfaces is effected by
surface micro texture, and whether it differs from the effects
generated by PEEK-based substrates. This in vitro study compared
angiogenic factor production and integrin gene expression of human
osteoblast-like MG63 cells cultured on PEEK or titanium-aluminum
vanadium (titanium alloy). Based on these study results, the applicant
asserted that the use of micro textured surfaces has demonstrated
greater promotion of osteoblast differentiation when compared to use of
PEEK-based surfaces.
The applicant maintains that the nanoLOCK[supreg] was the first,
and remains the only, device in spinal fusion, to apply for and
successfully obtain a clearance for nanotechnology from the FDA.
According to the applicant, in order for a medical device to receive a
nanotechnology FDA clearance, the burden of proof includes each of the
following to be present on the medical device in question: (1) Proof of
specific nano scale features, (2) proof of capability to manufacture
nano-scale features with repeatability and documented frequency across
an entire device, and (3) proof that those nano-scale features provide
a scientific benefit, not found on devices where the surface features
are not present. The applicant further stated that many of the
commercially available interbody fusion devices are created using
additive manufacturing processes to mold or build surface from the
ground up. Conversely, Titan Spine applied a subtractive surface
manufacturing to remove pieces of a surface. The surface features that
remain after this subtractive process generate features visible at
magnifications that additive manufacturing has not been able to
produce. According to the applicant, this subtractive process has been
validated by the White House Office of Science and Technology, the
National Nanotechnology Initiative, and the FDA that provide clearances
to products that
[[Page 41322]]
exhibit unique and repeatable features at predictive frequency due to a
manufacturing technique.
With regard to the second criterion, whether a product is assigned
to the same or a different MS-DRG, cases representing patients that may
be eligible for treatment involving the Titan Spine nanoLOCK[supreg]
technology would map to the same MS-DRGs as other (lumbar and cervical)
interbody devices currently available to Medicare beneficiaries and
also are used for the treatment of patients who have been diagnosed
with DDD (lumbar or cervical).
With regard to the third criterion, 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, the applicant
stated that the Titan Spine nanoLOCK[supreg] can be used in the
treatment of patients who have been diagnosed with similar types of
diseases, such as DDD, and for a similar patient population receiving
treatment involving both lumbar and cervical interbody devices.
In summary, the applicant maintained that the Titan Spine
nanoLOCK[supreg] technology has a different mechanism of action when
compared to other spinal fusion devices. Therefore, the applicant did
not believe that the Titan Spine nanoLOCK[supreg] technology is
substantially similar to existing technologies.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20316), we stated
we were concerned that the Titan Spine nanoLOCK[supreg] interbody
devices may be substantially similar to currently available titanium
interbody devices because other roughened surface interbody devices
also stimulate bone growth. While there is a uniqueness to the
nanotechnology used by the applicant, other devices also stimulate bone
growth such as PEEK-based surfaces and, therefore, we were concerned
that the Titan Spine nanoLOCK[supreg] interbody devices use the same or
similar mechanism of action as other devices.
We invited public comments on whether the Titan Spine
nanoLOCK[supreg] interbody devices are substantially similar to
existing technologies and whether these devices meet the newness
criterion.
Comment: One commenter stated that similar products to the
nanoLOCK[supreg] interbody devices exist, and there is no unbiased
research to support the applicant's claims of the technology's results.
Several commenters referenced studies that show that nano-scale
enhanced Ti6A14V interbody fusion device surfaces promote a cellular
response to bone growth. The commenters stated that these studies show
that cells in the osteoblast lineage (MSCs, osteoprogenitor cells, and
osteoblasts) exhibited a more mature osteoblast phenotype when grown on
microtextured Ti and Ti6Al4V surfaces than on tissue culture
polystyrene (TCPS) or on other polymers like PEEK. The commenters
further stated that, moreover, cells on the Ti6Al4V surfaces produced
less inflammatory mediators, less apoptotic factors and less necrosis
factors than cells on PEEK surfaces (rough < smooth Ti6Al4V <<< smooth
PEEK) and that PEEK surfaces have long been associated with increased
fibrous encapsulation in vivo, which was recently identified to be due
to a direct upregulation of inflammatory factors from mesenchymal stem
cells growing on PEEK.
Response: We agree with the commenter that similar products to the
nanoLOCK[supreg] interbody devices exist. We also believe that the
current research supports the applicant's assertion that the
technology's nanoscale features, which exhibit a biological effect
(osteoblastic activity), have not been seen in other interbody fusion
devices. After consideration of the public comments we received, we
believe that the Titan Spine nanoLock[supreg] uses a unique mechanism
of action, a nano-scale level surface technology, to enhance bone
growth. Therefore, we believe the Titan Spine nanoLock[supreg] is not
substantially similar to other existing technologies and meets the
newness criterion.
The applicant provided three analyses of claims data from the FY
2016 MedPAR file to demonstrate that the Titan Spine nanoLOCK[supreg]
interbody devices meet the cost criterion. In the proposed rule, we
noted that cases reporting procedures involving lumbar and cervical
interbody devices would map to different MS-DRGs. As discussed in the
Inpatient New Technology Add On Payment Final Rule (66 FR 46915), two
separate reviews and evaluations of the technologies are necessary in
this instance because cases representing patients receiving treatment
for diagnoses associated with lumbar procedures that may be eligible
for use of the technology under the first indication would not be
expected to be assigned to the same MS DRGs as cases representing
patients receiving treatment for diagnoses associated with cervical
procedures that may be eligible for use of the technology under the
second indication. Specifically, cases representing patients who have
been diagnosed with lumbar DDD and who have received treatment that
involved implanting a lumbar interbody device would map to MS DRG 028
(Spinal Procedures with MCC), MS-DRG 029 (Spinal Procedures with CC or
Spinal Neurostimulators), MS DRG 030 (Spinal Procedures without CC/
MCC), MS-DRG 453 (Combined Anterior/Posterior Spinal Fusion with MCC),
MS-DRG 454 (Combined Anterior/Posterior Spinal Fusion with CC), MS-DRG
455 (Combined Anterior/Posterior Spinal Fusion without CC/MCC), MS-DRG
456 (Spinal Fusion Except Cervical with Spinal Curvature or Malignancy
or Infection or Extensive Fusions with MCC), MS DRG 457 (Spinal Fusion
Except Cervical with Spinal Curvature or Malignancy or Infection or
Extensive Fusion without MCC), MS-DRG 458 (Spinal Fusion Except
Cervical with Spinal Curvature or Malignancy or Infection or Extensive
Fusions without CC/MCC), MS-DRG 459 (Spinal Fusion Except Cervical with
MCC), and MS-DRG 460 (Spinal Fusion Except Cervical without MCC). Cases
representing patients who have been diagnosed with cervical DDD and who
have received treatment that involved implanting a cervical interbody
device would map to MS DRG 471 (Cervical Spinal Fusion with MCC), MS-
DRG 472 (Cervical Spinal Fusion with CC), and MS-DRG 473 (Cervical
Spinal Fusion without CC/MCC). Procedures involving the implantation of
lumbar and cervical interbody devices are assigned to separate MS DRGs.
Therefore, the devices categorized as lumbar interbody devices and the
devices categorized as cervical interbody devices must distinctively
(each category) meet the cost criterion and the substantial clinical
improvement criterion in order to be eligible for new technology add on
payments beginning in FY 2019.
The first analysis searched for any of the ICD-10-PCS procedure
codes within the code series Lumbar-0SG [body parts 0 1 3] [open
approach only 0] [device A only] [anterior column only 0, J], which
typically are assigned to MS DRGs 028, 029, 030, and 453 through 460.
The average case-weighted unstandardized charge per case was $153,005.
The applicant then removed charges related to the predicate technology
and then standardized the charges. The applicant then applied an
inflation factor of 1.09357, the value used in the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38527) to update the charges from FY 2016 to FY
2018. The applicant added charges related to the Titan Spine
nanoLOCK[supreg] lumbar interbody devices. This resulted in a final
inflated average case-weighted standardized charge per case of
$174,688, which exceeded the average
[[Page 41323]]
case-weighted Table 10 MS-DRG threshold amount of $83,543.
The second analysis searched for any of the ICD-10-PCS procedure
codes within the code series Cervical-0RG [body parts 0-A] [open
approach only 0] [device A only] [anterior column only 0, J], which
typically are assigned to MS-DRGs 028, 029, 030, 453 through 455, and
471 through 473. The average case-weighted unstandardized charge per
case was $88,034. The methodology used in the first analysis was used
for the second analysis, which resulted in a final inflated average
case-weighted standardized charge per case of $101,953, which exceeded
the average case-weighted Table 10 MS-DRG threshold amount of $83,543.
The third analysis was a combination of the first and second
analyses described earlier that searched for any of the ICD-10-PCS
procedure codes within the Lumbar and Cervical code series listed above
that are assigned to the MS-DRGs in the analyses above. The average
case-weighted unstandardized charge per case was $127,736. The
methodology used for the first and second analysis was used for the
third analysis, which resulted in a final inflated average case-
weighted standardized charge per case of $149,915, which exceeded the
average case-weighted Table 10 MS-DRG threshold amount of $104,094.
Because the final inflated average case-weighted standardized
charge per case exceeded the average case-weighted threshold amount in
all of the applicant's analyses, the applicant maintained that the
technology met the cost criterion.
We invited public comments on whether the Titan Spine
nanoLOCK[supreg] meets the cost criterion.
We did not receive any public comments concerning whether the Titan
Spine nanoLOCK[supreg] meets the cost criterion or the cost analysis
presented in the proposed rule. We believe that the Titan Spine
nanoLOCK[supreg] meets the cost criterion.
With regard to the substantial clinical improvement criterion for
the Titan Spine nanoLOCK[supreg] Interbody Lumbar and Cervical Devices,
the applicant submitted the results of two clinical evaluations. The
first clinical evaluation was a case series and the second was a case
control study. Regarding the case series, 4 physicians submitted
clinical information on 146 patients. The 146 patients resulted from 2
surgery groups: A cervical group of 73 patients and a lumbar group of
73 patients. The division into cervical and lumbar groups was due to
differences in surgical procedure and expected recovery time.
Subsequently, the collection and analyses of data were presented for
lumbar and cervical nanoLOCK[supreg] device implants. Data was
collected using medical record review. Patient baseline
characteristics, the reason for cervical and lumbar surgical
intervention, inclusion and exclusion criteria, details on the types of
pain medications and the pattern of usage preoperatively and
postoperatively were not provided. In the proposed rule, we noted that
the applicant did not provide an explanation of why the outcomes
studied in the case series were chosen for review. However, the
applicant noted that the case series data were restricted to patients
treated with the Titan Spine nanoLOCK[supreg] device, with both
retrospective and prospective data collection. These data appeared to
be clinically related and included: (1) Pain medication usage; (2)
extremity and back pain (assessed using the Numeric Pain Rating Scale
(NPRS)); and (3) function (assessed using the Oswestry Disability Index
(ODI)). Clinical data collection began with time points defined as
``Baseline (pre-operation), Month 1 (0-4 weeks), Month 2 (5-8 weeks),
Month 3 (9-12 weeks), Month 4 (13-16 weeks), Month 5 (17-20 weeks) and
Month 6+ (>20 weeks)''. The n, mean, and standard deviation were
presented for continuous variables (NPRS extremity pain, back pain, and
ODI scores), and the n and percentage were presented for categorical
variables (subjects taking pain medications). All analyses compared the
time point (for example, Month 1) to the baseline.
Pain scores for extremities (leg and arm) were assessed using the
NPRS, an 11 category ordinal scale where 0 is the lowest value and 10
is the highest value and, therefore, higher scores indicate more severe
pain. Of the 73 patients in the lumbar group, the applicant presented
data on 18 cases for leg or arm pain at baseline that had a mean score
of 6.4, standard deviation (SD) 2.3. Between Month 1 and Month 6+ the
number of lumbar patients for which data was submitted for leg or arm
pain ranged from 3 patients (Month 5, mean score 3.7, SD 3.5) to 15
patients (Month 6+, mean score 2.5, SD 2.4), with varying numbers of
patients for each of the other defined time points of Month 1 through
Month 4. None of the defined time points of Month 1 through Month 4 had
more than 14 patients or less than 3 patients that were assessed.
Of the 73 patients in the cervical group, 7 were assessed for leg
or arm pain at baseline and had a mean score of 5.1, SD 3.5. Between
Month 1 and Month 6+ the number of cervical patients assessed for leg
or arm pain ranged from 0 patients (Month 5, no scores) to 5 patients
(Month 1, mean score 4.2, SD 2.6), with varying numbers of patients for
each of the other defined time points of Month 1 through Month 4. None
of the defined time points of Month 1 through Month 4 had more than 5
patients or less than 2 patients that were assessed.
Back pain scores were also assessed using the NPRS, where 0 is the
lowest value and 10 is the highest value and, therefore, higher scores
indicate more severe pain. Of the 73 patients in the lumbar group, 66
were assessed for back pain at baseline and had a mean score of 7.9, SD
1.8. Between Month 1 and Month 6+ the number of lumbar patients
assessed for back pain ranged from 4 patients (Month 5, mean score 4.0,
SD 2.7) to 43 patients (Month 1, mean score 4.5, SD 2.7), with varying
numbers of patients for each defined time point.
Of the 73 patients in the cervical group, 71 were assessed for back
pain at baseline and had a mean score of 7.5, SD 2.3. Between Month 1
and Month 6+ the number of cervical patients assessed for back pain
ranged from 2 patients (Month 5, mean score 7.0, SD 2.8) to 47 patients
(Month 1, mean score 4.4, SD 2.9), with varying numbers of patients for
each defined time point.
Function was assessed using the ODI, which ranges from 0 to 100,
with higher scores indicating increased disability/impairment. Of the
73 patients in the lumbar group, 59 were assessed for ODI scores at
baseline and had a mean score of 52.5, SD 18.7. Between Month 1 and
Month 6+ the number of lumbar patients assessed for ODI scores ranged
from 3 patients (Month 5, mean score 33.3, SD 19.8) to 38 patients
(Month 1, mean score 48.1, SD 19.7), with varying numbers of patients
for each defined time point. Of the 73 patients in the cervical group,
56 were assessed for ODI scores at baseline and had a mean score of
53.6, SD 18.2. Between Month 1 and Month 6+ the number of cervical
patients assessed for ODI score ranged from 1 patient (Month 5, mean
score 80, no SD noted) to 41 patients (Month 1, mean score 48.6, SD
20.5), with varying numbers of patients for each defined time point.
The percentages of patients not taking pain medicines per day for
the lumbar and cervical groups over time were assessed. Of the 73
patients in the lumbar group, 69 were assessed at baseline and 27.5
percent of the 69 patients were not taking pain medication. Between
Month 1 and Month 6+ the number of lumbar patients assessed for not
taking pain medicines ranged from 5 patients
[[Page 41324]]
(Month 5, 80 percent were not taking pain medicines) to 46 patients
(Month 1, 54.3 percent were not taking pain medicines), with varying
numbers of patients for each defined time point. Of the 73 patients in
the cervical group, 72 were assessed and 22.2 percent of the 72
patients were not taking pain medicines at baseline. Between Month 1
and Month 6+ the number of cervical patients assessed for not taking
pain medicines ranged from 2 patients (Month 5, 100 percent were not
taking pain medicines) to 50 patients (Month 1, 70 percent were not
taking pain medicines), with varying numbers of patients for each
defined time point.
According to the applicant, both the lumbar and cervical groups
showed a trend of improvement in all four clinical outcomes over time
for which they collected data in their case series. However, the
applicant also indicated that the trend was difficult to assess due to
the relatively limited number of subjects with available assessments
more than 4 months post-implant. The applicant shared that it had
missing values for over 80 percent of the subjects in the study after
the 4th post-operative month. According to the applicant and its
results of the clinical evaluation, which was based on data from less
than 20 percent of subjects, there was a statistically significant
reduction in back pain for nanoLOCK[supreg] patients from ``Baseline,''
based on improvement at earlier than standard time points.
In the proposed rule, we stated we were concerned that the small
sample size of patients assessed at each timed follow-up point for each
of the clinical outcomes evaluated in the case series limited our
ability to draw meaningful conclusions from these results. The
applicant provided t-test results for the lumbar and cervical groups
assessed for pain (back, leg, and arm). We indicated we were concerned
that the t-test resulting from small sample sizes (for example, 2 of 73
patients in Month 5, and 5 of 73 patients in Month 6+) does not
indicate a statistically meaningful improvement in pain scores.
Based on the results of the case series provided by the applicant,
we stated that we were unable to determine whether the findings
regarding extremity and back pain, ODI scores, and percentage of
subjects not taking pain medication for patients who received treatment
involving the Titan Spine nanoLOCK[supreg] devices represent a
substantial clinical improvement due to the inconsistent sample size
over time across both treatment arms in all evaluated outcome measures.
The quantity of missing data in this case series, along with the lack
of explanation for the missing data, raised concerns for the
interpretation of these results. We also stated that we were unable to
determine based on this case series whether there were improvements in
extremity pain and back pain, ODI scores, and percentage of subjects
not taking pain medicines for patients who received treatment involving
the Titan Spine nanoLOCK[supreg] devices versus conventional and other
intervertebral body fusion devices, as there were no comparisons to
current therapies. As noted in the proposed rule and above, the
applicant did not provide an explanation of why the outcomes studied in
the case series were chosen for review. Therefore, we believed that we
may have had insufficient information to determine if the outcomes
studied in the case series are validated proxies for evidence that the
nanoLOCK[supreg]'s surface promotes greater osteoblast differentiation
when compared to use of PEEK-based surfaces. We invited public comments
regarding our concerns, including with respect to why the outcomes
studied in the case series were chosen for review.
We note that, we did not receive any public comments with respect
to why the outcomes in the case series were selected for review.
The applicant's second clinical evaluation was a case-control study
with a 1:5 case to control ratio. The applicant used deterministically
linked, de-identified, individual level health care claims, electronic
medical records (EMR), and other data sources to identify 70 cases and
350 controls for a total sample size of 420 patients. The applicant
also identified OM1TM data source and noted that the
OM1TM data source reflects data from all U.S. States and
territories and is representative of the U.S. national population. The
applicant used OM1TM data between January 2016 and June
2017, and specifically indicated that these data contain medical and
pharmacy claims information, laboratory data, vital signs, problem
lists, and other clinical details. The applicant indicated that cases
were selected using the ICD-10-PCS Section ``X'' New Technology codes
listed above and controls were chosen from fusion spine procedures
(Fusion Spine Anterior Cervical, Fusion Spine Anterior Cervical and
Discectomy, Fusion Spine Anterior Posterior Cervical, Fusion Spine
Transforaminal Interbody Lumbar, Fusion Spine Cervical Thoracic, Fusion
Spine Transforaminal Interbody Lumbar with Navigation, and Fusion Spine
Transforaminal Interbody Lumber Robot-Assisted). Further, the applicant
stated that cases and controls were matched by age (within 5 years),
year of surgery, Charlson Comorbidity Index, and gender. According to
the applicant, regarding clinical outcomes studied, unlike the case
series, the case-control study captured Charlson Comorbidity Index, the
average length of stay (ALOS), and 30-day unplanned readmissions; like
the case series, this case-control study captured the use of pain
medications by assessing the cumulative post-surgical opioid use.
The mean age for all patients in the study was 55 years old, and 47
percent were male. For the clinical length of stay outcome, the
applicant noted that the mean length of stay was slightly longer among
control patients, 3.9 days (SD=5.4) versus 3.2 days (SD=2.9) for cases,
and a larger proportion of patients in the control group had lengths of
stay equal to or longer than 5 days (21 percent versus 17 percent).
Three control patients (0.8 percent) were readmitted within 30 days
compared to zero readmissions among case patients. A slightly lower
proportion of case patients were on opioids 3 months post-surgery
compared to control patients (15 percent versus 16 percent).
In the proposed rule (83 FR 20318), we stated we were concerned
that there may be significant outliers not identified in the case and
control arms because for the mean length of stay outcome, the standard
deviation for control patients (5.4 days) is larger than the point
estimate (3.9 days). Based on the results of this clinical evaluation
provided by the applicant, we stated that we were unable to determine
whether the findings regarding lengths of stay and cumulative post-
surgical opioid use for patients who received treatment involving the
nanoLOCK[supreg] devices versus conventional intervertebral body fusion
devices represent a substantial clinical improvement. We stated that
without further information on selection of controls and whether there
were adjustments in the statistical analyses controlling for
confounding factors (for example, cause of back pain, level of
experience of the surgeon, BMI and length of pain), we were concerned
that the interpretation of the results may be limited. Finally, we
stated we were concerned that the current data does not adequately
support a strong association between the outcome measures of length of
stay, readmission rates, and use of opioids and the use of nano-surface
textures in the manufacturing of the Titan Spine nanoLOCK[supreg]
device. For these reasons, we stated that we were concerned that the
current data do not support a substantial clinical
[[Page 41325]]
improvement over the currently available devices used for lumbar and
cervical DDD treatment.
In the proposed rule, we noted that the applicant indicated its
intent to submit the results of additional ongoing studies to support
the evidence of substantial clinical improvement over existing
technologies for patients who received treatment involving the
nanoLOCK[supreg] devices versus patients receiving treatment involving
other interbody fusion devices. We invited public comments on whether
the Titan Spine nanoLOCK[supreg] meets the substantial clinical
improvement criterion.
Comment: The applicant submitted a Milligram Morphine Equivalent
(MME) analysis. According to the applicant, the purpose of the analysis
is to demonstrate support for the ``substantial clinical value'' in the
reduction of MME with the implant of a Titan Spine nanoLOCK[supreg]
device. The applicant indicated that the MME analysis was conducted to
assess the impact of nanoLOCK[supreg] versus control devices on total
MME and narcotic usage. The applicant submitted the results of the MME
analysis as additional demonstration to support the representation of a
substantial clinical improvement over existing technologies as stated
in their application, and indicated that the data will be published
soon as a peer-reviewed journal article. The applicant explained that
control devices represented a mix of interbody fusion devices,
including PEEK and alternative roughened titanium devices without nano-
surface technology. The applicant stated that all nanoLOCK[supreg]
patients were classified as having an interbody fusion device with a
nano technology coated surface. The applicant further indicated that
all patients received either an allograft or autograft biologic in
addition to the implant device. The applicant stated that follow-up
time was recorded at 3 points: Follow-up #1--28.71 days (S.D. 20.64);
Follow-up #2--65.07 days (S.D. 33.91); and Follow-up #3--104.21 days
(S.D. 40.91). According to the applicant, a patient's baseline MME was
also a significant predictor of MME at first follow-up when adjusted
for all other variables in the model. The applicant stated that, at
Follow-up #1, there was a total of 926 patients with data regarding the
days from surgery to the first follow-up. The applicant indicated that,
according to the MME analysis, of the 926 patients at the time of
Follow-up #1, 47 patients had missing data. The applicant further
stated that results show there were 873 patients with data on narcotic
usage at the time of the first follow-up, with 100 patients with
missing data, and 391 patients with data on the total MME, with 582
missing data at the time of final analysis of follow-up #1. The
applicant stated that the results from the remaining 391 patients
represent only 42 percent of the original study participants. The
applicant explained that results indicated the mean total MME of
patients was 21.83 units (SD: 42.63). The applicant further stated that
there were 349 patients who were using narcotics for pain at the time
of their first follow-up. The applicant explained that all missing data
was addressed through pairwise deletion. The applicant believed that
this analysis further demonstrated that patients who received
nanoLOCK[supreg] had a significantly lower total MME at first follow-up
when compared to control devices patients when adjusted for the
following variables: Age, male versus female, history of prior spine
surgery, current smoker versus non-smoker, baseline MME, concomitant
medical condition, cervical versus lumbar, nanoLOCK[supreg] versus
control, single versus multi-level surgery, and intra-op complication.
The applicant stated that, based on the results of the MME analysis,
the use of nanoLOCK[supreg] reduced total MME by MME 24.47 units (95
percent CI: 14.42 to 34.52 units) more than patients who received
treatment using a control device. The applicant explained that a
patient's baseline MME was also a significant predictor of MME at first
follow-up when adjusted for all other variables in the model. The
applicant noted that the lack of standardized registries to collect
spine data, combined with the inability to access CMS registry
information in advance, means that the multiple examples provided by
the applicant regarding the use of nanoLOCK[supreg] are the most robust
information available and the consistency in outcomes with statistical
significance means the product's attributes generate clinical value.
Response: We appreciate the additional data provided by the
applicant. However, we are unable to determine the substantial clinical
value based on the analysis' data, due in part to the vast amount of
missing data and inconsistencies in the data provided. For example, at
each point of follow-up the number of patients in the analysis' cohort
is reduced, and ``missing'' numbers of patients in the cohort are
listed. Although the analysis attempts to account for the missing
patients and patients' data by pairwise deletions, we are unable to
determine a consistent cohort of patients for which a possible
reduction in MME usage may have occurred. We attempted to assess for a
pattern of consistency with the ``missing'' data and have been unable
to determine any such pattern. Additionally, while the applicant stated
that it used a sample size of n=926 patients, throughout the analyses
we noted varying numbers of patients for many of the variables included
as covariates, making it difficult to arrive at a meaningful
conclusion. We also note that the applicant did not provide further
information on our concern for the selection of controls and whether
there were adjustments in the statistical analyses controlling for
confounding factors (for example, cause of back pain, level of
experience of the surgeon, BMI and length of pain).
Comment: One commenter stated that the nanoLOCK[supreg] provides a
substantial clinical benefit, which is evidenced by multiple third-
party analytics evaluations that were performed outside of the
manufacturer's control. The commenter stated that these analytic
evaluations have found that the nanoLOCK[supreg] technology has led to
reduced hospital inpatient mean length of stay, fewer total
readmissions over 30 days post operation, and decreased use of
prescription opioids for post-operative spinal surgery patients.
However, the commenter did not provide the specific third-party
analytic evaluations with its public comment submission. Several
commenters believed that the nanoLOCK[supreg] technology represents a
substantial clinical improvement over current devices based on personal
experience. One commenter stated that within its specific patient
population, patients are returning to work faster, participating in
more physical therapy, and reducing their use of opiate pain
medications. Another commenter with personal experience with the
nanoLOCK[supreg] technology also stated that substantial improvement
within the fusion patient population had been recognized because of the
granted access to the nano-surface technology. The commenter noted that
patients are back to work earlier, starting physical therapy earlier,
and require less narcotic medication after surgery compared to earlier
patients who received treatment involving other fusion implants.
Response: We appreciate the input and additional information from
the commenters in support for the Titan Spine nanoLOCK[supreg] based on
personal surgical experience and third party analytics. However, we
note that the comments based on personal surgical experience were of a
qualitative nature and did not contain objective data to support
whether the Titan Spine nanoLOCK[supreg] meets the substantial
[[Page 41326]]
clinical improvement criterion. We believe that the Titan Spine
nanoLock[supreg] may potentially be a viable alternative to existing
technologies. However, the data provided did not show that use of
nanoLock[supreg] interbody fusion devices provides a substantial
clinical improvement over existing technologies.
After consideration of all the information from the applicant, as
well as the public comments we received, we are unable to determine if
the Titan Spine nanoLOCK[supreg] represents a substantial clinical
improvement over the currently available devices used for lumbar and
cervical DDD treatment due to a lack of significant and meaningful
data. As stated above, we remain concerned that the current data does
not adequately support a sufficient association between the outcome
measures of length of stay, readmission rates, and use of opioids and
the use of nano-surface textures in the manufacturing of the Titan
Spine nanoLOCK[supreg] device to determine that the technology
represents a substantial clinical improvement over existing available
options. Therefore, after consideration of all of the new technology
add-on payment criteria we are not approving new technology add-on
payments for the Titan Spine nanoLock[supreg] devices for FY 2019.
f. ZEMDRITM (Plazomicin)
Achaogen, Inc. submitted an application for new technology add-on
payments for Plazomicin for FY 2019. We note that, since the
publication of the proposed rule, the applicant has announced that the
trade name for Plazomicin is ZEMDRITM. According to the
applicant, ZEMDRITM (Plazomicin) is a next-generation
aminoglycoside antibiotic, which has been found in vitro to have
enhanced activity against many multi-drug resistant (MDR) gram-negative
bacteria. We stated in the proposed rule that the proposed indication
for the use of Plazomicin, which had not received FDA approval as of
the time of the development of this proposed rule, was for the
treatment of adult patients who have been diagnosed with the following
infections caused by designated susceptible microorganisms: (1)
Complicated urinary tract infection (cUTI), including pyelonephritis;
and (2) bloodstream infections (BSIs). We indicated that the applicant
stated that it expected that Plazomicin would be reserved for use in
the treatment of patients who have been diagnosed with these types of
infections who have limited or no alternative treatment options, and
would be used only to treat infections that are proven or strongly
suspected to be caused by susceptible microorganisms. The applicant
received approval from the FDA on June 25, 2018, for Plazomicin with
the trade name ZEMDRITM for use in the treatment of adults
with cUTIs, including pyelonephritis.
The applicant stated that there is a strong need for antibiotics
that can treat infections caused by MDR Enterobacteriaceae,
specifically carbapenem resistant Enterobacteriaceae (CRE). Life-
threatening infections caused by MDR bacteria have increased over the
past decade, and the patient population diagnosed with infections
caused by CRE is projected to double within the next 5 years, according
to the Centers for Disease Control and Prevention (CDC). Infections
caused by CRE are often associated with poor patient outcomes due to
limited treatment options. Patients who have been diagnosed with BSIs
due to CRE face mortality rates of up to 50 percent. Patients most at
risk for CRE infections are those with CRE colonization, recent
hospitalization or stay in a long-term care or skilled-nursing
facility, an extensive history of antibacterial use, and whose care
requires invasive devices like urinary catheters, intravenous (IV)
catheters, or ventilators. The applicant estimated, using data from the
Center for Disease Dynamics, Economics & Policy (CDDEP), that the
Medicare population that has been diagnosed with antibiotic-resistant
cUTI numbers approximately 207,000 and approximately 7,000 for BSIs/
sepsis due to CRE.
The applicant noted that due to the public health concern of
increasing antibiotic resistance and the need for new antibiotics to
effectively treat MDR infections, Plazomicin has received the following
FDA designations: Breakthrough Therapy; Qualified Infectious Disease
Product, Priority Review; and Fast Track. The applicant noted that
Breakthrough Therapy designation was granted on May 17, 2017, for the
treatment of bloodstream infections (BSIs) caused by certain
Enterobacteriaceae in patients who have been diagnosed with these types
of infections who have limited or no alternative treatment options. The
applicant noted that Plazomicin is the first antibacterial agent to
receive this designation. The applicant noted that on December 18,
2014, the FDA designated Plazomicin as a Qualified Infectious Disease
Product (QIDP) for the indications of hospital-acquired bacterial
pneumonia (HAPB), ventilator-associated bacterial pneumonia (VABP), and
complicated urinary tract infection (cUTI), including pyelonephritis
and catheter-related blood stream infections (CRBSI). The applicant
noted that Fast Track designation was granted by the FDA on August 12,
2012, for the Plazomicin development program for the treatment of
serious and life-threatening infections due to CRE. In the FY 2019
IPPS/LTCH PPS proposed rule (83 FR 20320), we indicated that Plazomicin
had not received approval from the FDA as of the time of the
development of the proposed rule. However, as noted previously, the
applicant received approval from the FDA on June 25, 2018, for
Plazomicin with the trade name ZEMDRITM for use in the
treatment of adults with cUTIs, including pyelonephritis. We note that,
for the remainder of this discussion in this final rule, the two
technology names are referenced interchangeably. The applicant did not
receive FDA approval for use in the treatment of BSIs.
The applicant's request for approval for a unique ICD-10-PCS
procedure code to identify the use of ZEMDRITM was granted,
and the following procedure codes: XW033G4 (Introduction of Plazomicin
anti-infective into peripheral vein, percutaneous approach, new
technology group 4) and XW043G4 (Introduction of Plazomicin anti-
infective into central vein, percutaneous approach, new technology
group 4) are effective October 1, 2018.
As discussed earlier, if a technology meets all three of the
substantial similarity 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant asserted that Plazomicin does not use the same or similar
mechanism of action to achieve a therapeutic outcome as any other drug
assigned to the same or a different MS-DRG. The applicant stated that
Plazomicin has a unique chemical structure designed to improve activity
against aminoglycoside-resistant bacteria, which also are often
resistant to other key classes of antibiotics, including beta-lactams
and carbapenems. Bacterial resistance to aminoglycosides usually occurs
through enzymatic modification by aminoglycoside modifying enzymes
(AMEs) to compromise binding the target bacterial site. According to
the applicant, AMEs were found in 98.6 percent of aminoglycoside
nonsusceptible E. coli, Klebsiella spp, Enterobacter spp, and Proteus
spp collected in 2016 U.S. surveillance
[[Page 41327]]
studies. Genes encoding AMEs are typically located on elements that
also carry other causes of antibiotic resistance like B-lactamase and/
or carbapenemase genes. Therefore, extended spectrum beta-lactamases
(ESBL) producing Enterobacteriaceae and CRE are commonly resistant to
currently available aminoglycosides. According to the applicant,
Plazomicin contains unique structural modifications at key positions in
the molecule to overcome antibiotic resistance, specifically at the 6
and N1 positions. These side chain substituents shield Plazomicin from
inactivation by AMEs, such that Plazomicin is not inactivated by any
known AMEs, with the exception of N-acetyltransferase (AAC) 2'-Ia, -Ib,
and -Ic, which is only found in Providencia species. According to the
applicant, as an aminoglycoside, Plazomicin also is not hydrolyzed by
B-lactamase enzymes like ESBLs and carbapenamases. Therefore, the
applicant asserted that Plazomicin is a potent therapeutic agent for
treating MDR Enterobacteriaceae, including aminoglycoside-resistant
isolates, CRE strains, and ESBL-producers.
The applicant asserted that the mechanism of action is new due to
the unique chemical structure. With regard to the general mechanism of
action against bacteria, in the proposed rule, we stated we were
concerned that the mechanism of action of Plazomicin appeared to be
similar to other aminoglycoside antibiotics. As with other
aminoglycosides, Plazomicin is bactericidal through inhibition of
bacterial protein synthesis. The applicant maintained that the
structural changes to the antibiotic constitute a new mechanism of
action because it allows the antibiotic to remain active despite AMEs.
Additionally, the applicant stated that Plazomicin would be the first,
new aminoglycoside brought to market in over 40 years.
We invited public comments on whether Plazomicin's mechanism of
action is new, including comments in response to our concern that its
mechanism of action to eradicate bacteria (inhibition of bacterial
protein synthesis) may be similar to that of other aminoglycosides,
even if improvements to its structure may allow Plazomicin to be active
even in the presence of common AMEs that inactivate currently marketed
aminoglycosides.
Comment: The applicant stated, in response to CMS' concern, that
ZEMDRITM's (Plazomicin's) mechanism of action is not
substantially similar to that of existing aminoglycosides because
modifications in the chemical structure allow ZEMDRITM to
both withstand resistance and reach the target site of action for
antibacterial efficacy. The applicant indicated that
ZEMDRITM is the first intravenous (IV) aminoglycoside
approved by the FDA in over 35 years that uses a protein synthesis as
its target site, combined with unique structural modifications that
withstand bacterial resistance mechanisms that render currently
marketed aminoglycosides ineffective. The applicant believed that
consideration of the mechanism of action for antibiotics should include
how it defends itself against inactivation by the bacteria, in addition
to how it kills the bacteria because the increasing emergence of
antibiotic resistance requires that new drugs not only exert
bactericidal action, but also how the new drugs overcome bacterial
resistance. The applicant stated that the ability of an antibiotic to
withstand resistance is equally important as the ability to work at the
target site because without the first action, the latter would not
matter. Therefore, the applicant posited that, while
ZEMDRITM's mechanism of bacterial killing is similar to
other aminoglycosides, its ability to withstand antibiotic resistance
due to AMEs is substantially different and represents an improvement in
the treatment of patients diagnosed with serious gram-negative
bacterial infections. The applicant indicated that, in the event of
resistance, the antibiotic cannot kill the bacteria without further
extension of mechanisms to protect against this resistance, regardless
of its site of action. The applicant stated that other aminoglycosides,
in contrast to ZEMDRITM, do not have the modifications that
allow them to withstand common mechanisms of resistance and, thereby,
cannot bind to the target site of antibacterial action and are
inactive. The applicant further explained that, specifically, the
structural modifications in Plazomicin protects the antibiotic from
most AMEs produced by bacteria that inactivates other aminoglycosides
including gentamicin, tobramycin, and amikacin. The applicant stated
that ZEMDRITM inhibits 90 percent of the Enterobacteriaceae,
including those resistant to one or more aminoglycoside antibiotics at
a concentration of <=4 mcg/mL (the proposed breakpoint for Plazomicin).
The applicant also noted that ZEMDRITM is already protected
by at least four issued patents in the U.S., representing the general
innovative and novel characteristics of the compound.
Another commenter noted that CMS' concerns focused on commonalities
between Plazomicin and other antibiotics in the same general antibiotic
class, and stated that the unique benefits of this medicine should not
be ignored due to the substantial similarities to other medicines,
given the recognized shortage of new antibiotics.
Response: We appreciate the applicant and the commenter's input
regarding the technology. After consideration of the comments we
received from the applicant regarding ZEMDRITM's mechanism
of action, we agree that ZEMDRITM's ability to withstand
antibiotic resistance is a critical component of its mechanism of
action because it enables the antibiotic to effectively inhibit
bacterial protein synthesis despite aminoglycoside resistance.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, we believe that potential cases
representing patients who may be eligible for treatment involving
Plazomicin would be assigned to the same MS-DRGs as cases representing
patients who receive treatment for UTI or bacteremia.
Comment: The applicant agreed with CMS and stated that use of
ZEMDRITM will not change the MS-DRG assignment for potential
cases representing eligible patients.
Response: We appreciate the applicant's input. We note that, the
FDA approval for ZEMDRITM was only for the treatment of
patients 18 years of age or older who have been diagnosed with a cUTI,
including pyelonephritis, and not for the other proposed indication of
bacteremia/BSI. Therefore, we are only considering the MS-DRG
assignment for potential cases representing eligible patients for the
approved indication.
With respect to the third criterion, 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, we indicated in the
proposed rule that the applicant asserted that Plazomicin is intended
for use in the treatment of patients who have been diagnosed with cUTI,
including pyelonephritis, and bloodstream infections, who have limited
or no alternative treatment options. We stated that because the
applicant anticipated that Plazomicin would be reserved for use in the
treatment of patients who have limited or no alternative treatment
options, the applicant believed that Plazomicin may be indicated to
treat a new patient population for which no other technologies are
available. However, we stated that it is possible that existing
antimicrobials could also be used to treat those same bacteria
Plazomicin is
[[Page 41328]]
intended to treat. Specifically, we indicated that the applicant was
seeking FDA approval for use in the treatment of patients who have been
diagnosed with cUTI, including pyelonephritis, caused by the following
susceptible microorganisms: Escherichia coli (including cases with
concurrent bacteremia), Klebsiella pneumoniae, Proteus spp (including
P. mirabilis and P. vulgaris), and Enterobactercloacae, and for use in
the treatment of patients who have been diagnosed with BSIs caused by
the following susceptible microorganisms: Klebsiella pneumonia and
Escherichia coli. We stated that because the susceptible organisms for
which Plazomicin was proposed to be indicated include nonresistant
strains that existing antibiotics may effectively treat, we were
concerned that Plazomicin may not treat a new patient population.
Therefore, we invited public comments on whether Plazomicin treats a
new type of disease or a new patient population. We also invited public
comments on whether Plazomicin is substantially similar to any existing
technologies and whether it meets the newness criterion. As noted
previously, Plazomicin received approval with the trade name
ZEMDRITM for use in the treatment of patients 18 years of
age or older with cUTI, including pyelonephritis.
Comment: The applicant disagreed with CMS' concern that
ZEMDRITM may not treat a new patient population, and stated
that most existing antibiotics are not effective against MDR strains of
bacteria, especially extended spectrum b-lactamase (ESBL)-producing
Enterobacteriaceae and CRE. The applicant further stated that, because
of the FDA's methodology for determining antibiotic labels and
indication of bacteria, ZEMDRITM is indicated for resistant
and also nonresistant strains of bacteria, but the FDA label approving
ZEMDRITM for the treatment of diagnoses of cUTIs, including
pyelonephritis, includes the following statement limiting the
indication to a new patient population: As only limited clinical safety
and efficacy data are available, reserve ZEMDRITM for use in
patients who have limited or no alternative treatment options. The
applicant further indicated that ZEMDRITM treats a new
patient population because patients infected with pathogens that are
resistant to other antibiotics include patients with infections due to
CRE, which is considered ``untreatable'' or ``hard to treat'' by the
CDC. The applicant emphasized that the CDC cautions that CRE infections
are increasing and resistant to ``all or nearly all'' antibiotics. The
applicant stated that ZEMDRITM meets CMS' criterion for
newness by providing, due to its mechanism to withstand resistance and
its potent activity against CRE considered by the CDC as
``untreatable'', a new treatment choice for a patient population that
may not have a viable option for a cure.
Several other commenters supported the approval of new technology
add-on payments for Plazomicin, and believed that Plazomicin treats a
new patient population with very limited treatment options. The
commenters specifically indicated that there is a need for new
antibiotics to combat the crisis of multi-drug resistant bacteria,
especially CRE infections. The commenters stated that there at least
70,000 cases of CRE annually in the United States, and the number is
expected to double in 4 years. The commenters also noted that the CDC
estimates that CRE infections are associated with mortality rates of up
to 50 percent and occur in the most medically vulnerable patient
populations. The commenters further recommended CMS acknowledge that as
these organisms are becoming resistant to last-line antibiotic drugs,
clinicians frequently face infections with no realistic treatment
options for patients. The commenters also indicated that the CDC
identified CRE as one of the three urgent drug-resistant threats to
human health, and issued warning that without urgent action more
patients will be ``thrust back to a time before we had effective
drugs.'' Another commenter also noted that the World Health
Organization identified CRE as one of the three pathogens with the
highest priority for research and development of novel antimicrobials,
and stated that Plazomicin is new because it has demonstrated
superiority over historic regimens for the management of invasive CRE
infections.
The applicant and other commenters also stated that, even with
newly approved antibiotic products with activity against some CRE,
development of resistance has already been reported resulting in
patients having no other available treatment options. The applicant and
other commenters further stated that there is a need for more than one
effective antibiotic active against CRE for many reasons, including
various patient characteristics such as drug allergies, source location
of bacteria, and the need for two active antibiotics given at the same
time--a common practice for multi-drug or pan-drug resistance.
Therefore, the commenters believed that multiple antibiotic treatment
options are necessary and the existence of other effective antibiotics
does not preclude a new antibiotic such as ZEMDRITM from
representing an improved benefit for a patient population with limited
or no other available treatment options.
Another commenter stated that it, generally, supported CMS'
concerns regarding the substantial similarity criteria for Plazomicin.
Response: We appreciate the applicant's and other commenters' input
on whether ZEMDRITM treats a new patient population. We
understand that antibiotic resistance poses a significant threat to
human health and that clinicians seek new antibiotics to treat multi-
drug resistant infections, particularly those caused by CRE. Regarding
our concern that ZEMDRITM is indicated for resistant and
also nonresistant strains of bacteria, we believe the FDA label
approving ZEMDRITM for the treatment of adult patients
diagnosed with a cUTI, including pyelonephritis, addresses this concern
by reserving ZEMDRITM for use in patients who have limited
or no alternative treatment options.
After consideration of the public comments we received, we believe
that the mechanism of action for ZEMDRITM is new, as
discussed above. Therefore, we believe that ZEMDRITM is not
substantially similar to any existing technologies and consequently
meets the newness criterion. We consider the beginning of the newness
period to commence when ZEMDRITM was approved by the FDA on
June 25, 2018.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that the technology meets the cost
criterion. The analyses submitted by the applicant and presented in the
proposed rule and below were for the indications of cUTI and BSI
because the applicant was seeking FDA approval for both indications.
However, as noted earlier, the technology was only approved for use in
the treatment of cUTI, including pyelonephrits. Therefore, while we
summarize both analyses below, as presented in the proposed rule, we
note that only the cost information related to cUTI is evaluated to
demonstrate that the applicant meets the cost criterion. We stated in
the proposed rule that in order to identify the range of MS-DRGs that
potential cases representing patients who have been diagnosed with the
specific types of infections for which the technology had been proposed
to be indicated for use in the treatment of and who may be potentially
eligible for treatment involving Plazomicin may map to, the applicant
identified all MS-DRGs in claims that
[[Page 41329]]
included cases representing patients who have been diagnosed with UTI
or Septicemia. The applicant searched the FY 2016 MedPAR data for
claims reporting 16 ICD-10-CM diagnosis codes for UTI and 45 ICD-10-CM
diagnosis codes for Septicemia and identified a total of 2,046,275
cases assigned to 702 MS-DRGs. The applicant also performed a similar
analysis based on 75 percent of identified claims, which spanned 43 MS-
DRGs. MS-DRG 871 (Septicemia or Severe Sepsis without Mechanical
Ventilation 96+ hours with MCC) accounted for roughly 25 percent of all
cases in the first analysis of the 702 MS-DRGs identified, and almost
35 percent of the cases in the second analysis of the 43 MS-DRGs
identified. Other MS-DRGs with a high volume of cases based on mapping
the ICD-10-CM diagnosis codes, in order of number of discharges, were:
MS-DRG 872 (Septicemia or Severe Sepsis without Mechanical Ventilation
96+ hours without MCC); MS-DRG 690 (Kidney and Urinary Tract Infections
without MCC); MS-DRG 689 (Kidney and Urinary Tract Infections with
MCC); MS-DRG 853 (Infectious and Parasitic Diseases with O.R. Procedure
with MCC); and MS-DRG 683 (Renal Failure with CC).
For the cost analysis summarized in the proposed rule, the
applicant calculated an average unstandardized case-weighted charge per
case using 2,046,275 identified cases (100 percent of all cases) and
using 1,533,449 identified cases (75 percent of all cases) of $69,414
and $63,126, respectively. The applicant removed 50 percent of the
charges associated with other drugs (associated with revenue codes
025x, 026x, and 063x) from the MedPAR data because the applicant
anticipated that the use of Plazomicin would reduce the charges
associated with the use of some of the other drugs, noting that this
was a conservative estimate because other drugs would still be required
for these patients during their hospital stay. The applicant then
standardized the charges and applied the 2-year inflation factor of
9.357 percent from the FY 2018 IPPS/LTCH PPS final rule (82 FR 38527)
to inflate the charges from FY 2016 to FY 2018. No charges for
Plazomicin were added in the analysis because the applicant explained
that the anticipated price for Plazomicin had yet to be determined.
Based on the FY 2018 IPPS/LTCH PPS Table 10 thresholds, the average
case-weighted threshold amount was $56,996 in the first scenario
utilizing 100 percent of all cases, and $55,363 in the second scenario
utilizing 75 percent of all cases. The inflated average case-weighted
standardized charge per case was $62,511 in the first scenario and
$57,054 in the second analysis. Because the inflated average case-
weighted standardized charge per case exceeded the average case-
weighted threshold amount in both scenarios, the applicant maintained
that the technology met the cost criterion. The applicant noted that
the case-weighted threshold amount is met before including the average
per patient cost of the technology in both analyses. As such, the
applicant anticipated that the inclusion of the cost of Plazomicin, at
any price point, would further increase charges above the average case-
weighted threshold amount.
The applicant also supplied additional cost analyses that we
summarized in the proposed rule, directing attention at each of the two
proposed indications individually; the cost analyses considered
potential cases representing patients who have been diagnosed with cUTI
who may be eligible for treatment involving Plazomicin separately from
potential cases representing patients who have been diagnosed with BSI/
Bacteremia who may be eligible for treatment involving Plazomicin, with
the cost analysis for each considering 100 percent and 75 percent of
identified cases using the FY 2016 MedPAR data and the FY 2018 GROUPER
Version 36. For the additional cost analyses summarized in the proposed
rule, the applicant reported that, for potential cases representing
patients who have been diagnosed with Bacteremia and who may be
eligible for treatment involving Plazomicin, 100 percent of identified
cases spanned 539 MS-DRGs, with 75 percent of the cases mapping to the
following 4 MS-DRGs: 871 (Septicemia or Severe Sepsis without
Mechanical Ventilation 96+ hours with MCC), 872 (Septicemia or Severe
Sepsis without Mechanical Ventilation 96+ hours without MCC), 853
(Infectious and Parasitic Diseases with O.R. Procedure with MCC), and
870 (Septicemia or Severe Sepsis with Mechanical Ventilation 96+
hours).
According to the applicant, for potential cases representing
patients who have been diagnosed with cUTI and who may be eligible for
treatment involving Plazomicin, 100 percent of identified cases mapped
to 702 MS-DRGs, with 75 percent of the cases mapping to 56 MS-DRGs.
Potential cases representing patients who have been diagnosed with
cUTIs and who may be eligible for treatment involving Plazomicin
assigned to MS-DRG 871 (Septicemia or Severe Sepsis without Mechanical
Ventilation 96+ hours with MCC) accounted for approximately 18 percent
of all of the cases assigned to any of the identified 56 MS-DRGs (75
percent of cases sensitivity analysis), followed by MS-DRG 690 (Kidney
and Urinary Tract Infections without MCC), which comprised almost 13
percent of all of the cases assigned to any of the identified 56 MS-
DRGs. Two other common MS-DRGs containing potential cases representing
potential patients who may be eligible for treatment involving
Plazomicin who have been diagnosed with the specific type of indicated
infections for which the technology is intended to be used, using the
applicant's analysis approach for UTI based on mapping the ICD-10-CM
diagnosis codes were: MS-DRG 872 (Septicemia or Severe Sepsis without
Mechanical Ventilation 96+ hours without MCC) and MS-DRG 689 (Kidney
and Urinary Tract Infections with MCC).
According to the applicant's analyses submitted prior to the FDA
approval, as stated in the proposed rule, for potential cases
representing patients who have been diagnosed with BSI and who may be
eligible for treatment involving Plazomicin, the applicant calculated
the average unstandardized case-weighted charge per case using
1,013,597 identified cases (100 percent of all cases) and using 760,332
identified cases (75 percent of all cases) of $87,144 and $67,648,
respectively. The applicant applied the same methodology as the
combined analysis above. Based on the FY 2018 IPPS/LTCH PPS final rule
Table 10 thresholds, the average case-weighted threshold amount for
potential cases representing patients who have been diagnosed with BSI
assigned to the MS-DRGs identified in the sensitivity analysis was
$66,568 in the first scenario utilizing 100 percent of all cases, and
$61,087 in the second scenario utilizing 75 percent of all cases. The
inflated average case-weighted standardized charge per case was $77,004
in the first scenario and $60,758 in the second scenario; in the 100
percent of Bacteremia cases sensitivity analysis, the final inflated
case-weighted standardized charge per case exceeded the average case-
weighted threshold amount for potential cases representing patients who
have been diagnosed with BSI and who may be eligible for treatment
involving Plazomicin assigned to the MS-DRGs identified in the
sensitivity analysis by $10,436 before including costs of Plazomicin.
In the 75 percent of all cases sensitivity analysis scenario, the final
inflated case-weighted standardized charge per case did not
[[Page 41330]]
exceed the average case-weighted threshold amount for potential cases
representing patients who have been diagnosed with BSI assigned to the
MS-DRGs identified in the sensitivity analysis, at $329 less than the
average case-weighted threshold amount. In the proposed rule, we noted
that because the applicant had not yet determined pricing for
Plazomicin, however, it is possible that Plazomicin may also exceed the
average case-weighted threshold amount for potential cases representing
patients who have been diagnosed with BSI and who may be eligible for
treatment involving Plazomicin assigned to the MS-DRGs identified in
the 75 percent cases sensitivity analysis.
For potential cases representing patients who have been diagnosed
with cUTI and who may be eligible for treatment involving Plazomicin,
the applicant calculated the average unstandardized case-weighted
charge per case using 100 percent of all cases and 75 percent of all
cases of $59,908 and $48,907, respectively. The applicant applied the
same methodology as the combined analysis above. Based on the FY 2018
IPPS/LTCH PPS final rule Table 10 thresholds, the average case-weighted
threshold amount for potential cases representing patients who have
been diagnosed with cUTI and who may be eligible for treatment
involving Plazomicin assigned to the MS-DRGs identified in the first
scenario utilizing 100 percent of all cases was $51,308, and $46,252 in
the second scenario utilizing 75 percent of all cases. The inflated
average case-weighted standardized charge per case was $53,868 in the
first scenario and $45,185 in the second scenario. In the 100 percent
of cUTI cases sensitivity analysis, the final inflated case-weighted
standardized charge per case exceeded the average case-weighted
threshold amount for potential cases representing patients who have
been diagnosed with cUTI and who may be eligible for treatment
involving Plazomicin assigned to the MS-DRGs identified in the 100
percent of all cases sensitivity analysis by $2,560 before including
costs of Plazomicin. In the 75 percent of all cases scenario, the final
inflated case-weighted standardized charge per case did not exceed the
average case-weighted threshold amount for potential cases representing
patients who have been diagnosed with cUTI and who may be eligible for
treatment involving Plazomicin assigned to the MS-DRGs identified in
the 75 percent sensitivity analysis, at $1,067 less than the average
case-weighted threshold amount. In the proposed rule, we noted that
because the applicant had not yet determined pricing for Plazomicin,
however, it is possible that Plazomicin may also exceed the average
case-weighted threshold amount for potential cases representing
patients who have been diagnosed with cUTI and who may be eligible for
treatment involving Plazomicin assigned to the MS-DRGs identified in
the 75 percent of all cases sensitivity analysis if charges for
Plazomicin are more than $1,067. We invited public comments on whether
Plazomicin meets the cost criterion.
We note that the FDA approval for ZEMDRITM was only for
the treatment of adults with complicated urinary tract infections cUTI,
including pyelonephritis, and not for the other proposed indication of
BSI. Therefore, we are only considering the cost analysis supplied by
the applicant which considered potential cases representing patients
who have been diagnosed with cUTI who may be eligible for treatment
involving Plazomicin.
Comment: The applicant believed that ZEMDRITM met the
cost criterion, but supplied additional information that included the
pricing for ZEMDRITM to update the cost threshold analyses
presented in the proposed rule. The applicant noted in supplemental
information submitted to CMS the WAC of ZEMDRITM (which is
supplied as 500mg/10ml (50mg/mL) solution in a single dose vial) is
$330 per vial. The applicant indicated that the recommended dosage for
ZEMDRITM is 15mg/kg, every 24 hours administered as an IV
infusion based on patient weight. The applicant stated that, because
each vial contains 1,000 mg of ZEMDRITM, a single vial
provides the complete recommended dose for a single patient who weighs
100 kg or less. The applicant predicted that patients will typically
require 3 vials for the course of treatment with ZEMDRITM
per day, and the average duration of ZEMDRITM therapy is 5.5
days. Therefore, the applicant stated that the total cost of
ZEMDRITM per patient is $5,445. The applicant utilized the
national CCR for ``Drugs'' as listed in the FY 2018 IPPS/LTCH PPS final
rule to estimate hospital charges by dividing the total cost per
patient by the CCR ($5,445/0.194).
The applicant also updated the cost threshold analysis including
hospital charges for ZEMDRITM. The applicant's updated
analysis applied only to those ICD-10-CM diagnosis codes used to
identify cases representing patients who have been diagnosed with a
cUTI and who may be eligible for treatment involving
ZEMDRITM. The applicant included two scenarios considering
100 percent of identified cases mapping to 702 MS-DRGs and 75 percent
of identified cases mapping to 56 MS-DRGs using the FY 2016 MedPAR data
and the FY 2018 GROUPER Version 36. The applicant stated that, as
discussed in the FY 2019 IPPS/LTCH PPS proposed rule, potential cases
representing patients who have been diagnosed with cUTIs and who may be
eligible for treatment involving Plazomicin assigned to MS-DRG 871
(Septicemia or Severe Sepsis without Mechanical Ventilation 96+ hours
with MCC) accounted for approximately 18 percent of all of the cases
assigned to any of the identified 56 MS-DRGs (75 percent of cases
sensitivity analysis), followed by MS-DRG 690 (Kidney and Urinary Tract
Infections without MCC), which comprised almost 13 percent of all of
the cases assigned to any of the identified 56 MS-DRGs. The applicant
further stated that the two other common MS-DRGs containing potential
cases representing potential patients who may be eligible for treatment
involving Plazomicin who have been diagnosed with the specific type of
indicated infections for which the technology is intended to be used,
using the applicant's analysis approach for UTI based on mapping the
ICD-10-CM diagnosis codes were: MS-DRG 872 (Septicemia or Severe Sepsis
without Mechanical Ventilation 96+ hours without MCC) and MS-DRG 689
(Kidney and Urinary Tract Infections with MCC).
Consistent with the analysis submitted for the proposed rule, the
applicant calculated the average unstandardized case-weighted charge
per case using 100 percent of all cases and 75 percent of all cases of
$59,908 and $48,907, respectively. Consistent with the analysis
submitted for the proposed rule, based on the FY 2018 IPPS/LTCH PPS
final rule Table 10 thresholds, the average case-weighted threshold
amount for potential cases representing patients who have been
diagnosed with a cUTI and who may be eligible for treatment involving
Plazomicin assigned to the MS-DRGs identified in the first scenario
utilizing 100 percent of all cases was $51,308, and $46,252 in the
second scenario utilizing 75 percent of all cases. The applicant
utilized the same methodology described in the FY 2019 IPPS/LTCH PPS
proposed rule with the exception of adding charges for Plazomicin. The
applicant removed 50 percent of the charges associated with other drugs
(associated with revenue
[[Page 41331]]
codes 025x, 026x, and 063x), then standardized the charges and applied
the 2-year inflation factor of 9.357 percent from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38527) to inflate the charges from FY 2016 to FY
2018. After adding the charges for Plazomicin, the inflated average
case-weighted standardized charge per case was $81,935 in the first
scenario and $73,252 in the second scenario. The applicant indicated
that, in the 100 percent of cUTI cases sensitivity analysis, the final
inflated case-weighted standardized charge per case exceeded the
average case-weighted threshold amount for potential cases representing
patients who have been diagnosed with a cUTI and who may be eligible
for treatment involving Plazomicin assigned to the MS-DRGs identified
in the 100 percent of all cases sensitivity analysis by $30,627 after
including the cost of Plazomicin. The applicant further stated that, in
the 75 percent of all cases scenario, the final inflated case-weighted
standardized charge per case exceeded the average case-weighted
threshold amount for potential cases representing patients who have
been diagnosed with a cUTI and who may be eligible for treatment
involving Plazomicin assigned to the MS-DRGs identified in the 75
percent sensitivity analysis by $27,000 after including the cost of
Plazomicin. In both scenarios, the final inflated case-weighted
standardized charge per case exceeded the average case-weighted
threshold amount and, therefore, the applicant believed that
ZEMDRITM continued to meet the cost criterion.
Response: We appreciate the additional information received from
the applicant regarding the cost of ZEMDRITM and whether the
technology meets the cost criterion. After consideration of the public
comments we received, we agree that ZEMDRITM meets the cost
criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that Plazomicin is a next generation aminoglycoside
that offers a treatment option for a patient population who have
limited or no alternative treatment options. Patients who have been
diagnosed with BSI or cUTI caused by MDR Enterobacteria, particularly
CRE, are difficult to treat because carbapenem resistance is often
accompanied by resistance to additional antibiotic classes. For
example, CRE may be extensively drug resistant (XDR) or even pandrug
resistant (PDR). CRE are resistant to most antibiotics, and sometimes
the only treatment option available to health care providers is a last-
line antibiotic (such as colistin and tigecycline) with higher
toxicity. According to the applicant, Plazomicin would give the
clinician an alternative treatment option for patients who have been
diagnosed with MDR bacteria like CRE because it has demonstrated
activity against clinical isolates that possess a broad range of
resistance mechanisms, including ESBLs, carbapenemases, and
aminoglycoside modifying enzymes that limit the utility of different
classes of antibiotics. Plazomicin also can be used to treat patients
who have been diagnosed with BSI caused by resistant pathogens, such as
ESBL-producing Enterobacteriaceae, CRE, and aminoglycoside-resistant
Enterobacteriaceae. The applicant maintained that Plazomicin is a
substantial clinical improvement because it offers a treatment option
for patients who have been diagnosed with serious bacterial infections
that are resistant to current antibiotics. In the FY 2019 IPPS/LTCH PPS
proposed rule (83 FR 20322), we noted that Plazomicin is not indicated
exclusively for resistant bacteria, but rather for certain susceptible
organisms of gram-negative bacteria, including resistant and
nonresistant strains for which existing antibiotics may be effective.
We stated we were concerned that the applicant focused solely on
Plazomicin's activity for resistant bacteria and did not supply
information demonstrating substantial clinical improvement in treating
nonresistant strains in the bacteria families for which Plazomicin is
indicated. We note that because the FDA approval was for the cUTI
indication only, and not the BSI proposed indication, we are only
summarizing comments pertaining to the cUTI indication and evaluating
whether ZEMDRITM meets the substantial clinical improvement
criterion for use in the treatment of cUTI.
Comment: The applicant stated in response to CMS' concerns that the
EPIC study evaluated the efficacy of ZEMDRITM against both
susceptible and resistant organisms (ESBLs) in cUTIs against a highly
potent antibiotic, meropenem. The applicant noted that, although in
this study approximately 25 percent of the isolates were beta-lactamase
producers (ESBL), which are resistant to commonly used antibiotics such
as penicillins and cephalosporins, the remaining 75 percent were
susceptible to beta-lactam antibiotics (non-ESBL). Therefore, the
applicant indicated that, while ZEMDRITM's substantial
clinical benefit was particularly differentiated in patients with
infections due to MDR pathogens where limited or no alternative
therapies are available, ZEMDRITM also demonstrated a
clinical improvement in patients diagnosed with a cUTI, including acute
pyelonephritis, against pathogens that are susceptible to other
antibiotics. The applicant emphasized that the approved FDA label fully
addresses this concern because it restricts the use of
ZEMDRITM to patients diagnosed with a cUTI, including
pyelonephritis, who have limited or no alternative treatment options.
The applicant stated that the FDA labeling ensures that
ZEMDRITM is used exclusively to treat patients diagnosed
with infections due to resistant bacteria and will result in
ZEMDRITM's use in the treatment of patients where the
benefit outweighs the risk, which includes patients with infections due
to resistant pathogens such as ESBL-producing Enterobacteriaceae, non-
susceptible to other currently marketed aminoglycosides, and CRE when
other antibiotics cannot be used.
Response: We agree with the applicant that the FDA label addresses
this concern because it restricts the use of ZEMDRITM to
patients diagnosed with a cUTI, including pyelonephritis, who have
limited or no alternative treatment options.
The applicant stated that Plazomicin also meets the substantial
clinical improvement criterion because it significantly improves
clinical outcomes for a patient population compared to currently
available treatment options. Specifically, the applicant asserted that
Plazomicin has: (1) A mortality benefit and improved safety profile in
treating patients who have been diagnosed with BSI due to CRE; and (2)
statistically better outcomes at test-of-cure in patients who have been
diagnosed with cUTI, including higher eradication rates for ESBL-
producing pathogens, and lower rate of subsequent clinical relapses.
The applicant conducted two Phase III studies, CARE and EPIC. The CARE
trial compared Plazomicin to colistin, a last-line antibiotic that is a
standard of care agent for patients who have been diagnosed with BSI
when caused by CRE. The EPIC trial compared Plazomicin to meropenem for
the treatment of patients who have been diagnosed with cUTI/acute
pyelonephritis.
The CARE clinical trial was a randomized, open label, multi-center
Phase III study comparing the efficacy of Plazomicin against colistin
in the treatment of patients who have been diagnosed with BSIs or
hospital-acquired bacterial pneumonia (HABP)/ventilator-acquired
bacterial pneumonia
[[Page 41332]]
(VABP) due to CRE. Due to the small number of enrolled patients with
HAPB/VABP, however, results were only analyzed for patients who had
been diagnosed with BSI due to CRE. The primary endpoint was day 28
all-cause mortality or significant disease complications. Patients were
randomized to receive 7 to 14 days of IV Plazomicin or colistin, along
with an adjunctive therapy of meropenem or tigecycline. All-cause
mortality and significant disease complications were consistent
regardless of adjunctive antibiotics received, suggesting that the
difference in outcomes was driven by Plazomicin and colistin, with
little impact from meropenem and tigecycline. Follow-up was done at
test-of-cure (TOC; 7 days after last dose of IV study drug), end of
study (EOS; day 28), and long-term follow-up (LFU; day 60). Safety
analysis included all patients; microbiological modified intent-to-
treat (mMITT) analysis included 17/18 Plazomicin and 20/21 colisitin
patients. Baseline characteristics like age, gender, APACHE II score,
infection type, baseline pathogens, creatinine clearance, and
adjunctive therapy with either meropenem or tigecycline were comparable
in the Plazomicin and colistin groups.
According to the applicant, the following results demonstrate a
reduced mortality benefit in the patients who had been diagnosed with
BSI subset. All-cause mortality at day 28 in the Plazomicin group was
more than 5 times less than in the colistin group and all-cause
mortality or significant complications at day 28 was reduced by 39
percent in the Plazomicin group compared to the colistin group. There
was a large sustained 60-day survival benefit in the patients who had
been diagnosed with BSI subset, with survival approximately 70 percent
in the Plazomicin group compared to 40 percent in the colistin group.
Additionally, according to the applicant, faster median time to
clearance of CRE bacteremia of 1.5 versus 6 days for Plazomicin versus
colistin and higher rate of documented clearance by day 5 (86 percent
versus 46 percent) supported the reduced mortality benefit due to
faster and more sustained clearance of bacteremia and also demonstrated
clinical improvement in terms of more rapid beneficial resolution of
the disease.
The applicant maintained that Plazomicin also represents a
substantial clinical improvement in improved safety outcomes. Patients
treated with Plazomicin had a lower incidence of renal events (10
percent versus 41.7 percent when compared to colistin), fewer Treatment
Emergent Adverse Events (TEAEs), specifically blood creatinine
increases and acute kidney injury, and approximately 30 percent fewer
serious adverse events were in the Plazomicin group. According to the
applicant, other substantial clinical improvements demonstrated by the
CARE study for use of Plazomicin in patients who had been diagnosed
with BSI included lower rate of superinfections or new infections,
occurring in half as many patients treated with Plazomicin versus
colistin (28.6 percent versus 66.7 percent).
According to the applicant, the CARE study demonstrates decreased
all-cause mortality and significantly reduced disease complications at
day 28 (EOS) and day 60 for patients who had been diagnosed with BSI,
in addition to a superior safety profile to colistin. However, the
applicant stated that, with the achieved enrollment, this study was not
powered to support formal hypothesis testing and p-values and 90
percent confidence intervals are provided for descriptive purposes. The
total number of patients who had been diagnosed with BSI was 29, with
14 receiving Plazomicin and 15 receiving colistin. While we understand
the difficulty enrolling a large number of patients who have been
diagnosed with BSI caused by CRE due to severity of the illness and the
need for administering treatment promptly, we stated in the proposed
rule we were concerned that results indicating reduced mortality and
treatment advantages over existing standard of care for patients who
have been diagnosed with BSI due to CRE are not statistically
significant due to the small sample size. Therefore, we stated that we
were concerned that the results from the CARE study cannot be used to
support substantial clinical improvement.
Comment: A commenter agreed with CMS' assessment that results of
the CARE study are not statistically significant due to the small
sample size of 29 patients.
Response: We appreciate the commenter's input. However, we note
that, we are no longer evaluating whether ZEMDRITM meets the
substantial clinical improvement criterion for use in the treatment of
patients diagnosed with BSI because the FDA did not approve
ZEMDRITM for that proposed indication.
The EPIC clinical trial was a randomized, multi-center, multi-
national, double-blind study evaluating the efficacy and safety of
Plazomicin compared with meropenem in the treatment of patients who
have been diagnosed with cUTI based on composite cure endpoint
(achieving both microbiological eradication and clinical cure) in the
microbiological modified intent-to-treat (mMITT) population. Patients
received between 4 to 7 days of IV therapy, followed by optional oral
therapy like levofloxacin (or any other approved oral therapy) as step
down therapy for a total of 7 to 10 days of therapy. Test-of-cure (TOC)
was done 15 to 19 days and late follow-up (LFU) 24 to 32 days after the
first dose of IV therapy. Six hundred nine patients fulfilled inclusion
criteria, and were randomized to receive either Plazomicin or
meropenem, with 306 patients receiving Plazomicin and 303 patients
receiving meropenem. Safety analysis included 303 (99 percent)
Plazomicin patients and 301 (99.3 percent) meropenem patients. mMITT
analysis included 191 (62.4 percent) Plazomicin patients and 197 (65
percent) meropenem patients; exclusion from mMITT analysis was due to
lack of study-qualifying uropathogen, which were pathogens susceptible
to both Plazomicin and meropenem. In the mMITT population, both groups
were comparable in terms of gender, age, percentage of patients who had
been diagnosed with cUTI/acute pyelonephritis (AP)/urosepsis/
bacteremia/moderate renal impairment at baseline.
According to the applicant, Plazomicin successfully achieved the
primary efficacy endpoint of composite cure (combined microbiological
eradication and clinical cure). At the TOC visit, 81.7 percent of
Plazomicin patients versus 70.1 percent of meropenem patients achieved
composite cure; this was statistically significant with a 95 percent
confidence interval. Plazomicin also demonstrated higher eradication
rates for key resistant pathogens than meropenem at both TOC (89.4
percent versus 75.5 percent) and LFU (77 percent versus 60.4 percent),
suggesting that the Plazomicin treatment benefit observed at TOC was
sustained. Specifically, Plazomicin demonstrated higher eradication
rates, defined as baseline uropathogen reduced to less than 104,
against the most common gram-negative uropathogens, including ESBL
producing (82.4 percent Plazomicin versus 75.0 percent meropenem) and
aminoglycoside resistant (78.8 percent Plazomicin versus 68.6 percent
meropenem) pathogens. This was statistically significant, although of
note, as total numbers of Enterobacteriaceae exceeded population of
mMITT (191 Plazomicin, 197 meropenem) this presumably
[[Page 41333]]
included patients who were otherwise excluded from the mMITT
population.
According to the applicant, importantly, higher microbiological
eradication rates at the TOC and LFU visits were associated with a
lower rate of clinical relapse at LFU for Plazomicin treated patients
(3 versus 14, or 1.8 percent Plazomicin versus 7.9 percent meropenem),
with majority of the meropenem failures having had asymptomatic
bacteriuria; that is, positive urine cultures without clinical
symptoms, at TOC (21.1 percent), suggesting that the higher
microbiological eradication rate at the TOC visit in Plazomicin-treated
patients decreased the risk of subsequent clinical relapse. Plazomicin
decreased recurrent infection by four-fold compared to meropenem,
suggesting improved patient outcomes, such as reduced need for
additional therapy and re-hospitalization for patients who have been
diagnosed with cUTI. The safety profile of Plazomicin compared to
meropenem was similar. The applicant noted that higher bacteria
eradication results for Plazomicin were not due to meropenem
resistance, as only patients with isolates susceptible to both drugs
were included in the study. According to the applicant, the EPIC
clinical trial results demonstrate clear differentiation of Plazomicin
from meropenem, an agent considered by some as a gold-standard for
treatment of patients who have been diagnosed with cUTI in cases due to
resistant pathogens.
While the EPIC clinical trial was a non-inferiority study, the
applicant contended that statistically significant improved outcomes
and lower clinical relapse rates for patients treated with Plazomicin
demonstrate that Plazomicin meets the substantial clinical improvement
criterion for the cUTI indication. Specifically, according to the
applicant, the efficacy results for Plazomicin combined with a
generally favorable safety profile provide a compelling benefit-risk
profile for patients who have been diagnosed with cUTI, and
particularly those with infections due to resistant pathogens. Most
patients enrolled in the EPIC clinical trial were from Eastern Europe.
We expressed in the proposed rule that it is unclear how generalizable
these results would be to patients in the United States as the
susceptibilities of bacteria vary greatly by location. The applicant
maintained that this is consistent with prior studies and is unlikely
to have affected the results of the study because the pharmacokinetics
of Plazomicin and meropenem are not expected to be affected by race or
ethnicity. However, bacterial resistance can vary regionally and, in
the proposed rule, we expressed that we are interested in how this data
can be extrapolated to a majority of the U.S. population.
Comment: A commenter agreed with CMS' concern that results from the
EPIC clinical trial are predominately based on patients enrolled in
trials in Eastern Europe, and it is not clear how generalizable their
results would be to patients in the United States. The applicant stated
that the representation of the patients enrolled in the EPIC trial was
similar to other recent cUTI studies for drugs approved in the U.S.,
and the spectrum of diagnoses and bacteriology in these studies were
representative of the epidemiology and standard-of-care used in the
United States. The applicant further noted that the primary analysis
excluded pathogens resistant to either study drugs (ZEMDRITM
or meropenem) and, therefore, avoided imbalances due to geographic
differences in resistance. The applicant also provided additional data
to demonstrate that the results from the EPIC trial are generalizable
to patients treated in the U.S. because the susceptibilities of
bacteria to ZEMDRITM do not vary between patients in the
U.S. versus patients in Eastern Europe, and the pharmacokinetic profile
of ZEMDRITM or meropenem are not affected by race because
ZEMDRITM and meropenem are cleared almost entirely by the
kidneys rather than metabolized. The applicant further indicated that,
in the Phase II study of ZEMDRITM in patients diagnosed with
a cUTI (ACHN-490-009), a larger number of patients from the U.S. were
enrolled and outcomes were similar to those observed in the EPIC trial.
Response: We appreciate the commenter's input and the applicant's
additional explanation demonstrating the results from the EPIC trial.
We also stated that it is also unknown how quickly resistance to
Plazomicin might develop. Additionally, we stated that the
microbiological breakdown of the bacteria is unknown without the full
published results, and patients outside of the mMITT population were
included when the applicant reported the statistically superior
microbiological eradication rates of Enterobacteriaceae at TOC. In the
FY 2019 IPPS/LTCH PPS proposed rule, we stated we were concerned
whether there is still statistical superiority of Plazomicin in the
intended bacterial targets in the mMITT.
Comment: Regarding our concern about how quickly resistance to
ZEMDRITM might develop, the applicant stated that
ZEMDRITM's limited use indication, the short duration of
therapy, and oversight by the antimicrobial stewardship team will
prevent development of resistance, which is often associated with
widespread use of antibiotics. Specifically, the applicant indicated
that, unlike broad spectrum antibacterial drugs, the FDA restrictions
of ZEMDRITM's use helps to reduce development of resistance
and is consistent with antimicrobial stewardship programs recommended
by the CDC. The applicant also explained that the clinical dose of 15
mg/kg administered daily was selected to reduce the risk of emergence
of resistance to ZEMDRITM. The applicant further stated
that, because Plazomicin is generally not inactivated by common AMEs,
the primary mechanism of resistance to Plazomicin in Enterobacteriaceae
is target-site modification in isolates containing 16S-RMTases, which
are rarely encountered in the U.S. and do not appear to be increasing
in prevalence despite decades of clinical use of aminoglycoside class;
16S-RMTases were found in only 0.08 percent or 5 of approximately 6,500
U.S. Enterobacteriaceae isolates collected during a 2014 through 2016
surveillance study.
The applicant also provided data presenting the breakdown of the
uropathogens identified from baseline urine cultures in the mMITT
population in the EPIC study, and clarified that statistically superior
microbiological eradication rates observed with ZEMDRITM
compared to meropenem at TOC (Table 2) were achieved in the same mMITT
population used for the primary endpoint.
Response: We appreciate the additional information received from
the applicant explaining why ZEMDRITM has a low potential
for development of resistance and demonstrating ZEMDRITM's
statistical superiority in the intended bacterial targets in the mMITT
population.
Finally, because both Plazomicin and meropenem were also utilized
in conjunction with levofloxacin, we stated in the proposed rule that
it is unclear to us whether combined antibiotic therapy will continue
to be required in clinical practice, and how levofloxacin activity or
resistance might affect the clinical outcome in both patient groups.
Comment: The applicant clarified that levofloxacin was provided
only as an optional oral step-down therapy after pre-specified criteria
in the protocol were met, consistent with recent trials of other
antibiotics that have been evaluated for diagnoses of cUTIs. The
[[Page 41334]]
applicant explained that optional oral step-down therapy is commonly
used in clinical trials of cUTIs to increase study participation by
allowing patients to be discharged from the hospital following
favorable response to IV therapy, rather than staying in the hospital
for 10 days to receive the IV study drug. With regard to clinical
practice, the applicant noted that the FDA label does not require
patients to receive oral therapy following administration of
ZEMDRITM, and it would be the decision of the treating
physician if a patient may be switched to an oral agent following IV
infusion of ZEMDRITM and the physician would determine the
appropriate oral therapy, if applicable. The applicant indicated that
levofloxacin did not influence the outcome of the study because it was
used for a similarly short course in both the ZEMDRITM and
meropenem group, and the TOC visit outcomes continued to favor
ZEMDRITM in both patients who received the IV study drug
only and those who received the IV study drug followed by oral therapy.
Response: We appreciate the applicant's clarification regarding
levoflaxin's use in clinical practice, and agree that the use of
levoflaxin did not negate the study results favoring
ZEMDRITM because it was used similarly in both groups and
the TOC visit demonstrated improved outcomes for patients receiving
only ZEMDRITM, as well as patients receiving
ZEMDRITM followed by oral antibiotic therapy.
We invited public comments on whether Plazomicin meets the
substantial clinical improvement criterion for patients who have been
diagnosed with BSI and cUTI, including with respect to whether
Plazomicin constitutes a substantial clinical improvement for the
treatment of patients who have been diagnosed with BSI who have limited
or no alternative treatment options, and whether statistically better
outcomes at test-of-cure visit, including higher eradication rates for
ESBL-producing pathogens, and lower rate of subsequent clinical
relapses constitute a substantial clinical improvement for patients who
have been diagnosed with cUTI.
Comment: The applicant and other commenters believed that
ZEMDRITM represents a substantial clinical improvement for
patients who have been diagnosed with a cUTI. The commenters stated
that ZEMDRITM offers a substantial clinical improvement over
existing aminoglycosides, both in having a higher degree of
susceptibility against CRE and enhanced potency, which potentially
allows safer exposures of the drug. Another commenter described some of
the complications and limitations of existing therapies, including
colistin, polymyxin, tigecycline, ceftolozane/tazobactam, and
ceftazidime/avibactam, and the limited effectiveness of antibiotics
like amikacin, and noted that ZEMDRITM provides an exciting
option for transitions of care because it can be utilized in the
outpatient setting and administered once-daily by IV infusion. Another
commenter, generally, supported granting approval of new technology
add-on payments for ZEMDRITM and stated that this next-
generation aminoglycoside is a substantial innovation and advancement
in the treatment of serious bacterial infections due to MDR
enterobacteriaceae that commonly occur in the hospital setting.
Response: We appreciate the applicant's and other commenters' input
on whether ZEMDRITM offers a substantial clinical
improvement over current therapies for patients who have been diagnosed
with a cUTI. We believe that ZEMDRITM offers a substantial
clinical improvement for patients who have limited or no alternative
treatment options because it is a new antibiotic that offers a
treatment option for a patient population unresponsive to currently
available treatments. After consideration of the public comments we
received, we have determined that ZEMDRITM meets all of the
criteria for approval of new technology add-on payments. Therefore, we
are approving new technology add-on payments for ZEMDRITM
for FY 2019. Cases involving ZEMDRITM that are eligible for
new technology add-on payments will be identified by ICD-10-PCS
procedure codes XW033G4 and XW043G4.
In its application, the applicant estimated that the average
Medicare beneficiary would require a dosage of 15 mg/kg administered as
an IV infusion as a single dose. According to the applicant, the WAC
for one dose is $330, and patients will typically require 3 vials for
the course of treatment with ZEMDRITM per day for an average
duration of 5.5 days. Therefore, the total cost of ZEMDRITM
per patient is $5,445. Under Sec. 412.88(a)(2), we limit new
technology add-on payments 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 a case involving the use of ZEMDRITM is
$2,722.50 for FY 2019. In accordance with the current
ZEMDRITM label, CMS expects that ZEMDRITM will be
prescribed for adult patients diagnosed with cUTIs, including
pyelonephritis, who have limited or no alternative treatment options.
g. GIAPREZATM
The La Jolla Pharmaceutical Company submitted an application for
new technology add-on payments for GIAPREZATM for FY 2019.
GIAPREZATM, a synthetic human angiotensin II, is
administered through intravenous infusion to raise blood pressure in
adult patients who have been diagnosed with septic or other
distributive shock.
The applicant stated that shock is a life-threatening critical
condition characterized by the inability to maintain blood flow to
vital tissues due to dangerously low blood pressure (hypotension).
Shock can result in organ failure and imminent death, such that
mortality is measured in hours and days rather than months or years.
Standard therapy for shock currently uses fluid and vasopressors to
raise the mean arterial pressure (MAP). The two classes of standard of
care (SOC) vasopressors are catecholamines and vasopressins. Patients
do not always respond to existing standard of care therapies.
Therefore, a diagnosis of shock can be a difficult and costly condition
to treat. According to the applicant, 35 percent of patients who are
diagnosed with shock fail to respond to standard of care treatment
options using catecholamines and go on to second-line treatment, which
is typically vasopressin. Eighty percent of patients on vasopressin
fail to respond and have no other alternative treatment options. The
applicant estimated that CMS covered charges to treat patients who are
diagnosed with vasodilatory shock who fail to respond to standard of
care therapy are approximately 2 to 3 times greater than the costs of
other conditions, such as acute myocardial infarction, heart failure,
and pneumonia. According to the applicant, one-third of patients in the
intensive care unit are affected by vasodilatory shock, with 745,000
patients who have been diagnosed with shock being treated annually, of
whom approximately 80 percent are septic.
With respect to the newness criterion, according to the applicant,
the expanded access program (EAP), or FDA authorization for the
``compassionate use'' of an investigational drug outside of a clinical
trial, was initiated August 8, 2017. GIAPREZATM was granted
Priority Review status and received FDA approval on December 21, 2017,
for the use in the treatment of adults who have been diagnosed with
septic or other distributive shock as an intravenous infusion to
increase blood pressure. The
[[Page 41335]]
applicant submitted a request for approval for a unique ICD-10-PCS code
for the administration of GIAPREZATM beginning in FY 2019
and was granted approval for the following procedure codes effective
October 1, 2018: XW033H4 (Introduction of synthetic human angiotensin
II into peripheral vein, percutaneous approach, new technology, group
4) and XW043H4 (Introduction of synthetic human angiotensin II into
central vein, percutaneous approach, new technology group 4).
As discussed above, if a technology meets all three of the
substantial similarity 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, GIAPREZATM is the first
synthetic formulation of human angiotensin II, a naturally occurring
peptide hormone in the human body. Angiotensin II is one of the major
bioactive components of the renin-angiotensin-aldosterone system
(RAAS), which serves as one of the body's central regulators of blood
pressure. Angiotensin II increases blood pressure through
vasoconstriction, increased aldosterone release, and renal control of
fluid and electrolyte balance. Current therapies for the treatment of
patients who have been diagnosed with shock do not leverage the RAAS.
The applicant asserted that GIAPREZATM is a novel treatment
with a unique mechanism of action relative to SOC treatments for
patients who have been diagnosed with shock, which is adequate fluid
resuscitation and vasopressors. Specifically, the two classes of SOC
vasopressors are catecholamines like Norepinephrine, epinephrine,
dopamine, and phenylephrine IV solutions, and vasopressins like
Vasostrict[supreg] and vasopressin-sodium chloride IV solutions.
Catecholamines leverage the sympathetic nervous system and vasopressin
leverages the arginine-vasopressin system to regulate blood pressure.
However, the third system that works to regulate blood pressure, the
RAAS, is not currently leveraged by any available therapies to raise
mean arterial pressure in the treatment of patients who have been
diagnosed with shock. The applicant maintained that
GIAPREZATM is the first synthetic human angiotensin II
approved by the FDA and the only FDA-approved vasopressor that
leverages the RAAS and, therefore, GIAPREZATM utilizes a
different mechanism of action than currently available treatment
options.
The applicant explained that GIAPREZATM leverages the
RAAS, which is a body system not used by existing vasopressors to raise
blood pressure through inducing vasoconstriction. In the FY 2019 IPPS/
LTCH PPS proposed rule (83 FR 20325), we stated we were concerned that
GIAPREZATM's general mechanism of action, increasing blood
pressure by inducing vasoconstriction through binding to certain G-
protein receptors to stimulate smooth muscle contraction, may be
similar to that of norepinephrine, albeit leveraging a different body
system. We invited public comments on whether GIAPREZATM
uses a different mechanism of action to achieve a therapeutic outcome
with respect to currently available treatment options, including
comments or additional information regarding whether the mechanism of
action used by GIAPREZATM is different from that of other
treatment methods of stimulating vasoconstriction.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, we stated in the proposed rule that
we believe that potential cases representing patients who may be
eligible for treatment involving GIAPREZATM would be
assigned to the same MS-DRGs as cases representing patients who receive
SOC treatment for a diagnosis of shock. As explained below in the
discussion of the cost criterion, the applicant believed that potential
cases representing patients who may be eligible for treatment involving
GIAPREZATM would be assigned to MS-DRGs that contain cases
representing patients who have failed to respond to administration of
fluid and vasopressor therapies.
With respect to the third criterion, 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, according to the
applicant, once patients have failed treatment using catecholamines,
treatment options for patients who have been diagnosed with severe
septic or other distributive shock are limited. According to the
applicant, agents that were previously available are each associated
with their own adverse events (AEs). The applicant noted that primary
options that have been investigated include vasopressin,
corticosteroids, methylene blue, and blood purification techniques. Of
these options, the applicant stated that only vasopressin has a
recommendation as add on vasopressor therapy in current treatment
guidelines, but the recommendations are listed as weak with moderate
quality of evidence. According to the applicant, there is uncertainty
regarding vasopressin's effect on mortality due to mixed clinical trial
results, and higher doses of vasopressin have been associated with
cardiac, digital, and splanchnic ischemia. Therefore, the applicant
asserted that there is a significant unmet medical need for treatments
for patients who have been diagnosed with septic or distributive shock
who remain hypotensive, despite adequate fluid and vasopressor therapy
and for medications that can provide catecholamine-sparing effects.
The applicant also noted that there is currently no standard of
care for addressing the clinical state of septic or other distributive
shock experienced by patients who fail to respond to fluid and
available vasopressor therapy. Additionally, according to the
applicant, no clinical evidence or consensus for treatments is
available.
Based on the applicant's statements as summarized above, we stated
in the proposed rule that it appears that the applicant is asserting
that GIAPREZATM provides a new therapeutic treatment option
for critically-ill patients who have been diagnosed with shock who have
limited options and worsening prognosis. However, we further stated we
were concerned that GIAPREZATM may not offer a treatment
option to a new patient population, specifically because the FDA
approval for GIAPREZATM does not reserve the use of
GIAPREZATM only as a last-line drug or adjunctive therapy
for a subset of the patient population who have been diagnosed with
shock who have failed to respond to standard of care treatment options.
According to the FDA-approved labeling, GIAPREZATM is a
vasoconstrictor to increase blood pressure in adult patients who have
been diagnosed with septic or other distributive shock. Patients who
have been diagnosed with septic or other distributive shock are not a
new patient population. Therefore, we stated that it appears that
GIAPREZATM is used to treat the same or similar type of
disease (a diagnosis of shock) and a similar patient population
receiving SOC therapy for the treatment of shock.
In the proposed rule, we invited public comments on whether
GIAPREZATM meets the substantial similarity criteria and the
newness criterion.
Comment: The applicant indicated that GIAPREZATM is not
substantially similar to existing treatment options
[[Page 41336]]
because it is the sole member of a new class of vasopressor peptide,
and the only one that acts to leverage the renin-angiotensin-
aldosterone (RAAS) system. The applicant stated that
GIAPREZATM's mechanism of action is unique because
GIAPREZATM operates in a fundamentally different manner than
norepinephrine, in addition to leveraging a different body system. The
applicant noted, specifically, that GIAPREZATM causes
vasoconstriction of the smooth muscles and stimulates the release of
aldosterone from the adrenal cortex to promote sodium retention by the
kidneys, both of which lead to increased blood pressure. The applicant
explained that, although catecholamines, vasopressin, and angiotensin
II all engage G-coupled protein receptors for their function, they
engage entirely different G-coupled receptors subtypes and engage
different receptor targets. The applicant further described the
biochemical pathways unique to angiotensin, and recommended that CMS
consider the feedback mechanisms present in the classical RAAS,\123\
which enable GIAPREZATM to be more effective in the
treatment of diagnosis of shock than standard-of-care vasopressors. The
applicant provided literature and specific citations that suggested ACE
activity is diminished in conditions associated with vasodilatory
shock, which would result in a state of relative angiotensin II
deficiency, that is, excess angiotensin I, similar to a state induced
by ACE inhibitor treatment in patients who have been diagnosed with
essential hypertension.\124\ \125\ According to the applicant, in
vasodilatory shock syndromes, the addition of exogenous angiotensin II
attenuates production of angiotensin I by suppressing release of renin
at the juxtaglomerular apparatus, and potentially reduces angiotensin
(1-7) levels, resulting in a more normalized angiotensin I to/
angiotensin II ratio and a reduced endogenous vasodilator drive. In
contrast, the applicant asserted that norepinephrine is a catecholamine
that functions as a peripheral vasoconstrictor by acting on alpha-
adrenergic receptors and an inotropic stimulator of the heart and a
dilator of coronary arteries, a result of its activity at the beta-
adrenergic receptors. The applicant stated that, GIAPREZATM,
however, has a non-adrenergic mechanism of action that contributes to
its catecholamine-sparing effect. The applicant indicated that
GIAPREZATM can be administered in combination with
norepinephrine because GIAPREZATM affects vasoconstriction
not by augmentation of norepinephrine, but by way of an entirely novel
mechanism.
---------------------------------------------------------------------------
\123\ Sparks MA, Crowley SD, Gurley SB, Mirotsou M, Coffman TM.
Classical renin-angiotensin system in kidney physiology.
Comprehensive Physiology. 2014;4(3):1201-1228. doi:10.1002/
cphy.c130040.
\124\ Luque M, Martin P, Martell N, Fernandez C, Brosnihan KB,
Ferrario CM. Effects of captopril related to increased levels of
prostacyclin and angiotensin-(1-7) in essential hypertension. J
Hypertens. 1996;14:799-805.
\125\ Balakumar P, Jagadeesh G. A century-old renin-angiotensin
system still grows with endless possibilities: AT1 receptor
signaling cascades in cardiovascular physiopathology. Cell Signal.
2014;26(10):2147-60.
---------------------------------------------------------------------------
One commenter pointed out that vasoconstriction is a very general
and fundamental physiologic mechanism by which blood pressure is
regulated, such that it would occur with any regimen for treating
patients who have been diagnosed with shock.
Other commenters stated that current standard-of-care treatment
options only target two of the three major biological systems
regulating MAP, which makes GIAPREZATM the first and only
FDA-approved synthetic human angiotensin II treatment option that
activates the RAAS to increase MAP. The commenters believed that
GIAPREZA TM's unique mechanism of action supports a multi-
modal approach to the treatment of patients who have been diagnosed
with shock that mimics the body's natural response to hypotension, and
offers physicians a critical new tool for saving lives.
With respect to the second criterion, the applicant indicated that
there are inherent difficulties in capturing specific patient types for
a condition such as a diagnosis of shock, and explained that the
current structure of the MS-DRG payment system does not yet have the
refined elements necessary to identify those patients likely to respond
to treatment involving GIAPREZA TM. The applicant emphasized
that the MS-DRGs for Septicemia or Severe Sepsis with or without
Mechanical Ventilation >96 Hours are MS-DRGs that are noted frequently
as being in the top 10 highest volume Medicare MS-DRGs reported overall
each year. The applicant believed that medical DRGs that are driven by
complications have an inherently more challenging time demonstrating
uniqueness as a function of Medicare's MS-DRG GROUPER approach than the
medical device population. However, the applicant stated that as the
ICD-10-CM/PCS system continues to evolve and new MS-DRGs are added to
capture new technologies, there will be additional opportunities to
better highlight certain products' use, like GIAPREZATM, in
key populations.
Regarding the third criterion, the applicant contended that
although the FDA approval for GIAPREZATM is not reserved
exclusively for patients diagnosed with shock who have failed to
respond to standard-of-care treatment options, GIAPREZATM
still treats a new patient population that is a significant subset of
the larger patient population for which GIAPREZATM has
received FDA approval. Specifically, the applicant emphasized that, of
approximately 1.12 million hypotensive patients, greater than 50
percent fail the standard-of-care treatment practice and, therefore,
have no other available treatment options. The applicant believed that
GIAPREZATM provides a new treatment option for Medicare
beneficiaries that can be started immediately and can benefit the
patient within only approximately 5 minutes.
Other commenters similarly stated that GIAPREZATM fills
an unmet need for new treatment options for patients who have been
diagnosed with shock, considering that more than 50 percent of patients
who have been diagnosed with distributive shock fail to meet MAP goals
using the standard-of-care treatment options. The commenters emphasized
that mortality from shock remains high, especially in patients who have
been diagnosed with refractory shock, primarily due to progressive
hypotension and resulting organ failure and limited treatment options.
The commenters believed that GIAPREZATM offers a
breakthrough treatment option that promises to save lives by providing
an alternative treatment option for a subset of the shock patient
population for whom there was previously no other treatment options
available.
In addition to the public comments summarized above regarding
mechanism of action, MS-DRG assignment of potential cases eligible for
treatment involving use of GIAPREZATM, and the treatment of
the intended patient population, the applicant stated that prior to
approval of GIAPREZATM, only two classes of vasopressors
were available: Catecholamines and vasopressin, both of which have
narrow therapeutic windows and significant toxic effects when
administered at higher doses. The applicant further stated that
catecholamines are correlated to serious complications, such as
increased digital and limb necrosis \126\ and kidney injury.\127\ The
applicant explained that
[[Page 41337]]
vasopressin was the only non-catecholamine vasopressor available to
clinicians, but it fails to improve blood pressure in the majority of
patients, therefore, making its impact quite limited.\128\
Additionally, the applicant indicated that vasopressin is also slow to
take effect (peak effect at 15 minutes) and, therefore, is difficult to
titrate, to achieve and maintain the desired MAP, which further
complicates its use and leaves patients hypotensive for longer.\129\
\130\ The applicant further explained that last-resort adjuvant non-
vasopressor therapies such as corticosteroids, ascorbic acid, thiamine,
and methylene blue are still used in desperation, but none have been
shown to reliably improve blood pressure or survival. Therefore, the
applicant suggested that CMS recognize that GIAPREZATM
answers an unmet need for a safe, effective, fast-acting, alternative
therapy.\131\ With regard to newness, a couple of commenters stated
that GIAPREZATM is the first new vasopressor approved by the
FDA in over 40 years. To the contrary, another commenter stated that
it, generally, supported CMS' concerns about GIAPREZATM.
---------------------------------------------------------------------------
\126\ Brown SM, Lanspa MJ, Jones JP, et al. Survival After Shock
Requiring High-Dose Vasopressor Therapy. Chest. 2013;143(3):664-671.
doi:10.1378/chest.12-1106.
\127\ Gordon AC, Mason AJ, Thirunavukkarasu N, et al. Effect of
Early Vasopressin vs Norepinephrine on Kidney Failure in Patients
With Septic Shock. Jama. 2016;316(5):509. doi:10.1001/
jama.2016.10485.
\128\ Sacha GL, Lam SW, Duggal A, Torbic H, Reddy AJ, et al,
Hypotension risk based on vasoactive agent discontinuation order in
patients in the recovery phase of septic shock. Pharmacotherapy.
2018 Mar;38(3):319-326. doi: 10.1002/phar.2082. Epub 2018 Feb 8.
\129\ Vasostrict [Package Insert]. Chestnut Ridge, NY. Par
Pharmaceutical; 2016.
\130\ Malay MB, Ashton JL, Dahl K, Savage EB, Burchell SA,
Ashton RC Jr, et al. Heterogeneity of the vasoconstrictor effect of
vasopressin in septic shock. Crit Care Med. 2004;32(6):1327 31.
\131\ Andreis DT, Singer M. Catecholamines for inflammatory
shock: a Jekyll-and-Hyde conundrum. Intensive Care Med.
2016;42(9):1387-97.
---------------------------------------------------------------------------
Response: After review of the information provided by the applicant
and consideration of the public comments we received, we believe that
GIAPREZATM has a unique mechanism of action to achieve a
therapeutic outcome because it leverages the RAAS system to increase
blood pressure. Therefore, GIAPREZATM is not substantially
similar to existing treatment options and meets the newness criterion.
With regard to the cost criterion, the applicant conducted an
analysis for a narrower indication, patients who have been diagnosed
with refractory shock who have failed to respond to standard of care
vasopressors, and an analysis for a broader indication of all patients
who have been diagnosed with septic or other distributive shock. In the
FY 2019 IPPS/LTCH PPS proposed rule (82 FR 20325), we stated we
believed that only this broader analysis, which reflects the patient
population for which the applicant's technology is approved by the FDA,
is relevant to demonstrate that the technology meets the cost criterion
and, therefore, we only summarized this broader analysis in the
proposed rule (and below). In order to identify the range of MS-DRGs
that potential cases representing potential patients who may be
eligible for treatment using GIAPREZATM may map to, the
applicant used two separate analyses to identify the MS-DRGs for
patients who have been diagnosed with shock or related diagnoses. The
applicant also performed three sensitivity analyses on the MS-DRGs for
each of the two selections: 100 percent of the MS-DRGs, 80 percent of
the MS-DRGs, and 25 percent of the MS-DRGs. Therefore, a total of six
scenarios were included in the cost analysis.
The first analysis (Scenario 1) selected the MS-DRGs most
representative of the potential patient cases where treatment involving
GIAPREZATM would have the greatest clinical impact and
outcomes of improvement over present treatment options. The applicant
searched for 28 different ICD-9-CM codes under this scenario. The
second analysis (Scenario 2) used the 80 most relevant ICD-9-CM
diagnosis codes based on the inclusion criteria of the
GIAPREZATM Phase III clinical trial, ATHOS-3, and an
additional 8 ICD-9-CM diagnosis codes for clinical presentation
associated with vasodilatory or distributive shock patients failing
fluid and standard of care therapy to capture any additional potential
cases that may be applicable based on clinical presentations associated
with this patient population.
Among only the top quartile of potential patient cases, the single
MS-DRG representative of most potential patient cases was MS-DRG 871
(Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours
with MCC) for both ICD-9-CM diagnosis code selection scenarios, and in
both selections, it accounted for a potential patient case percentage
surpassing 25 percent. Because GIAPREZATM is not reserved
exclusively as a last-line drug based on the FDA indication, the
applicant removed 50 percent of drug charges for prior technologies or
other charges associated with prior technologies from the
unstandardized charges before standardization in order to account for
other drugs that may be replaced by the use of GIAPREZATM.
At the time of development of the proposed rule, the applicant had not
yet supplied CMS with pricing for GIAPREZATM and did not
include charges for the new technology when conducting this analysis.
For all analyses' scenarios, the applicant standardized charges using
the FY 2015 impact file and then inflated the charges to FY 2019 using
an inflation factor of 15.4181 percent (or 1.154181) by multiplying the
inflation factor of 1.098446 in the FY 2017 IPPS/LTCH PPS final rule
(81 FR 57286) by the inflation factor of 1.05074 in the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38524). The final inflated average case-
weighted standardized charge per case was calculated for each scenario
and compared with the average case-weighted threshold amount for each
group of MS-DRGs based on the thresholds in Table 10.
Results of the analyses for each of the two code selection
scenarios, each with three sensitivity analyses for a total of six
analyses, are summarized in the tables below:
----------------------------------------------------------------------------------------------------------------
Final average
Number of MS- Case- weighted inflated Amount
DRGs assessed Number of new technology standardized exceeded
Medicare cases add-on payment charge per threshold
threshold case
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 1
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (28 Codes):
100 Percent................. 439 120,966 $77,427 $111,522 $34,095
80 Percent.................. 10 96,102 77,641 100,167 22,526
25 Percent.................. 1 66,980 53,499 71,951 18,452
----------------------------------------------------------------------------------------------------------------
[[Page 41338]]
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 2
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (88 Codes):
100 Percent................. 466 164,892 78,675 112,174 33,499
80 Percent.................. 52 131,690 79,732 108,396 28,664
25 Percent.................. 1 67,016 53,499 71,688 18,189
----------------------------------------------------------------------------------------------------------------
The applicant maintained that, based on the Table 10 thresholds,
the inflated average case-weighted standardized charge per case in the
analyses exceeded the average case-weighted threshold amount. The
applicant noted that the inflated average case-weighted standardized
charge per case exceeds the average case-weighted threshold amount by
at least $18,189, without the average per patient cost of the
technology. As such, the applicant anticipated that the inclusion of
the cost of GIAPREZATM, at any price point, would further
increase charges above the average case-weighted threshold amount.
Therefore, the applicant stated that the technology met the cost
criterion. We noted in the proposed rule that we were unsure whether
the selection in both scenarios fully captures the broader indication
for which the FDA approved the use of GIAPREZATM. We invited
public comments on whether GIAPREZATM meets the cost
criterion, including with respect to the concern we had raised.
Comment: The applicant provided an updated cost analysis to broaden
the patient cases according to the expanded FDA-approved indication.
Specifically, the applicant stated that it removed the original
exclusion criteria, which previously limited the patient cases used in
the cost analysis to vasopressor-unresponsive patient cases, subjected
all three ICD-9-CM code selections to a broader procedure code
inclusion list, and additionally adjusted codes based on the clinical
profile of diagnoses of distributive/septic shock.
The applicant noted, as noted in the proposed rule, that the
inflated average case-weighted standardized charge per case exceeded
the average case-weighted threshold amount before including the average
per patient cost of the technology. The applicant also added charges
for the cost of the technology to its updated analysis. The applicant
indicated that the WAC of GIAPREZATM (which is supplied as a
2.5mg/1mL vial) is $1,500 per vial. The applicant stated that,
according to the FDA-approved labeling, the recommended dosage of
GIAPREZATM is 20 nanograms (ng)/kg/min administered as an IV
infusion, titrated as frequently as every 5 minutes by increments of up
to 15 ng/kg/min, as needed. The applicant stated that, because each
vial contains 2.5 mg of GIAPREZATM, a patient weighing 70 kg
infused for 48 hours at a constant dose of 20ng/kg/min would use 1.6
vials of GIAPREZATM. The applicant explained that, as vials
will be used in whole integers, each episode-of-care would require 2
vials and consequently would cost $3,000 per patient, per episode-of-
care, at the current WAC of $1,500.
To estimate the anticipated average charge submitted by hospitals
for use of GIAPREZATM, the applicant stated that it used a
conservative CCR of 0.5, which equated to the lower hospital markups
for similar drugs. The applicant subtracted 50 percent of the costs of
prior technology charges, which resulted in the final inflated average
standardized charge per case, which exceeded the Table 10 average case-
weighted threshold amounts by an average of $40,011, after the outlined
changes were made. The applicant submitted the following table
summarizing the updated cost threshold analysis:
Summary of Case-Weighted Cost-Threshold Analysis Using FY 2015 MedPAR Data (50 Percent of Pharmacy Charges) Post
Issuance of the FY 2019 IPPS/LTCH PPS Proposed Rule
----------------------------------------------------------------------------------------------------------------
Final inflated
Case- weighted average case-
Number of MS- Number of new technology weighted Amount
DRGs assessed Medicare cases add-on payment standardized exceeded
threshold charge per threshold
case
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 1
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (41 Codes):
100 Percent................. 711 816,386 $93,312 $134,127 $40,815
80 Percent.................. 55 652,298 97,759 134,733 36,974
25 Percent.................. 1 145,043 53,499 82,947 29,448
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 2
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (28 Codes):
100 Percent................. 499 318,168 93,324 148,143 54,819
80 Percent.................. 8 251,694 96,337 139,486 43,149
25 Percent.................. 1 145,345 53,499 82,900 29,401
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 3
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (99 Codes):
[[Page 41339]]
100 Percent................. 685 487,091 97,294 147,388 50,094
80 Percent.................. 45 388,622 103,664 149,700 46,036
25 Percent.................. 1 145,472 53,499 82,866 29,367
----------------------------------------------------------------------------------------------------------------
Response: After consideration of the public comments we received,
we agree that GIAPREZATM meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant summarized that it believes that GIAPREZATM
represents a substantial clinical improvement because it: (1) Addresses
an unmet medical need for patients who have been diagnosed with septic
or distributive shock that, despite standard of care vasopressors, are
unable to maintain adequate mean arterial pressure; (2) is the only
agent shown in randomized clinical trial to rapidly and sustainably
achieve or maintain target blood pressure in patients who do not
respond adequately to fluid and vasopressor therapy; (3) although not
powered for mortality, the ATHOS-3 trial demonstrated a strong trend to
reduce the risk of death in adults from septic or distributive shock
who remain hypotensive despite fluid therapy and vasopressor therapy, a
severe, life-threatening condition, for which there are no other
therapies; (4) provides a catecholamine-sparing effect; and (5) is
generally safe and well-tolerated, with no significant differences in
the percentages of patients with any grade adverse events or serious
adverse events when compared to placebo.
Expanding on the statements above, we stated in the proposed rule
that the applicant believes that the use of GIAPREZATM
offers clinicians a significant new tool to manage and treat severe
hypotension in all adult patients who have been diagnosed with septic
or other distributive shock who are unresponsive to existing
vasopressor therapies. The applicant also stated that the use of
GIAPREZATM provides a new therapeutic option for critically-
ill adult patients who have been diagnosed with septic or other
distributive shock who have limited options and worsening prognoses.
The applicant maintained that GIAPREZATM was shown to be
an effective treatment option for critically-ill patients who have been
diagnosed with refractory shock. The applicant reported that a
randomized, double-blind placebo controlled trial called ATHOS-3 \132\
examined the ability of GIAPREZATM to increase mean arterial
pressure (MAP), with the primary endpoint being achievement of a MAP of
greater than or equal to 75 mmHg (the research-backed guideline set by
the Surviving Sepsis Campaign) or a 10 mmHg increase in baseline MAP.
Significantly more patients in the treatment arm met the primary
endpoint (69.9 percent versus 23.4 percent, P<0.001). The applicant
asserted that this MAP improvement constitutes a significant
substantial clinical improvement because patients treated with
GIAPREZATM were three times more likely to achieve
acceptable blood pressure than patients receiving the placebo. The MAP
significantly and rapidly increased in patients treated with
GIAPREZATM and was sustained over 48 hours consistent across
subgroups and the treatment effect of GIAPREZATM was
confirmed using multivariate analysis. The group treated with
GIAPREZATM also experienced a greater mean increase in MAP;
the MAP increased by a mean of 12.5 mmHg for the GIAPREZATM
group compared to a mean of 2.9 mmHg for the placebo group.
---------------------------------------------------------------------------
\132\ Khanna, A., English, S.W., Wang, X.S., et al.,
``Angiotensin II for the treatment of vasodilatory shock,''
[supplementary appendix] [published online ahead of print May 21,
2017], N Engl J Med., 2017, doi: 10.1056/NEJMoa1704154.
---------------------------------------------------------------------------
Second, the applicant maintained that GIAPREZATM
demonstrated potential improvement in organ function by lowering the
cardiovascular sequential organ failure assessment (SOFA) scores of
patients at 48 hours (-1.75 GIAPREZATM group versus -1.28
placebo group). However, we stated in the proposed rule we were
concerned that lower cardiovascular SOFA scores may not demonstrate
substantial clinical improvement because there was no difference in the
improvement of other components of the SOFA score or the overall SOFA
score.
Third, the applicant asserted that GIAPREZATM represents
a substantial clinical improvement because the use of
GIAPREZATM reduced the need to increase overall doses of
catecholamine vasopressors. The applicant stated that patients
receiving higher doses of catecholamine vasopressors suffer from
cardiac toxicity, organ dysfunction, and other metabolic complications
that are associated with higher mortality. According to the applicant,
by decreasing the overall dosage of catecholamine vasopressors,
GIAPREZATM potentially reduces the adverse effects of
vasopressors. The mean change in catecholamine vasopressors in patients
receiving GIAPREZATM versus patients receiving the placebo
at 3 hours was -0.03 versus 0.03 (P<0.001), showing that
GIAPREZATM allowed for catecholamines to be titrated down,
while patients not receiving GIAPREZATM required additional
catecholamine doses. The vasopressor mean doses were consistently lower
in the GIAPREZATM group, and at 48 hours, vasopressors had
been discontinued in 28.5 percent of patients in the placebo group
versus 40.5 percent of the GIAPREZATM group. We noted in the
proposed rule that, while GIAPREZATM may potentially reduce
certain adverse effects associated with SOC treatments, the FDA-
approved labeling cautions that the use of GIAPREZATM can
cause dangerous blood clots with serious consequences (clots in
arteries and veins, including deep venous thrombosis); according to the
FDA-approved label, prophylactic treatment for blood clots should be
used.
In the proposed rule, we noted that the applicant stated that while
the study was not powered to detect mortality effects, there was a
nonsignificant trend toward longer survival in the
GIAPREZATM group. Overall mortality rates at 7 days and 8
days in the modified intent to treat (MITT) population were 22 percent
less in the GIAPREZATM group than in the placebo
[[Page 41340]]
group. At 28 days, the mortality rate in the placebo group was 54
percent versus 46 percent in the GIAPREZATM group. However,
the p-values for the decrease in mortality with GIAPREZATM
at 7 days, 8 days, and 28 days did not demonstrate statistical
significance.
The applicant concluded that GIAPREZATM is the first
commercial product to increase blood pressure in adults who have been
diagnosed with septic or other distributive shock that leverages the
renin-angiotensin-aldosterone system. The applicant stated that the
results of the ATHOS-3 study provide support for a well-tolerated new
therapeutic agent that demonstrates significant improvements in mean
arterial pressure. Additionally, the applicant noted that hypotension
in adults who have been diagnosed with septic or other distributive
shock is a prevalent life-threatening condition where therapeutic
options are limited and a high unmet medical need exists. The applicant
stated that the use of GIAPREZATM will represent a safe and
effective new therapy that not only leverages a system that current
therapies are not utilizing, but also offers a viable alternative where
one does not exist.
We stated in the proposed rule that we understood that, in this
heterogeneous and difficult to treat patient population, studies
assessing mortality as a primary endpoint are difficult, and as such,
surrogate endpoints (that is, achieving baseline MAP) have been
explored to assess the efficacy of treatments. While the outcomes
presented by the applicant, such as achieving target MAP, lower SOFA
scores, and reduced catecholamine usage, could be surrogates for
clinical outcomes in these patients, we stated that there is not a
strong pool of evidence connecting these single data points directly
with morbidity and mortality. Therefore, in the proposed rule, we
stated that we were unsure whether achieving target MAP, lower SOFA
scores, and reduced catecholamine usage represents a substantial
clinical improvement or instead short-term, temporary improvements
without a change in overall patient prognosis.
In response to this concern about MAP constituting a meaningful
measure for substantial clinical improvement, the applicant supplied
additional information from the current Surviving Sepsis guidelines,
which recommend an initial target MAP of 65 mmHg. The applicant
explained that as MAP falls below a critical threshold, inadequate
tissue perfusion occurs, potentially resulting in multiple organ
dysfunction and death. Therefore, early and adequate hemodynamic
support and treatment of hypotension is critical to restore adequate
organ perfusion and prevent worsening organ dysfunction and failure. In
diagnoses of septic or distributive shock, the goal of treatment is to
increase and maintain a threshold MAP in order to improve tissue
perfusion. According to the applicant, tissue perfusion becomes
linearly dependent on arterial pressure below a threshold MAP. In
patients who have been diagnosed with septic shock requiring
vasopressors, the current Surviving Sepsis guidelines are based on
available evidence that demonstrates that adequate MAP is important to
clinical outcomes and that prolonged decreases in MAP below 65 mmHg is
associated with poor outcome. According to information supplied by the
applicant, even short durations like less than 5 minutes of low MAP
have been associated with severe outcomes, such as myocardial
infarction, stroke, and acute kidney injury. The applicant stated that
a retrospective study \133\ found that MAP was independently related to
ICU and hospital mortality in patients with severe sepsis or septic
shock.
---------------------------------------------------------------------------
\133\ Walsh, M., Devereaux, P.J., Garg, A.X., et al.,
``Relationship between Intraoperative Mean Arterial Pressure and
Clinical Outcomes after Noncardiac Surgery Toward an Empirical
Definition of Hypotension,'' Anesthesiology, 2013, vol. 119(3), pp.
507-515.
---------------------------------------------------------------------------
Finally, we stated in the proposed rule that we were concerned that
the study results may demonstrate substantial clinical improvement only
for patients who are unresponsive to the administration of fluids and
vasopressors because patients were only included in the ATHOS-3 study
if they failed fluids and vasopressors, rather than for the broader
patient population of adult patients who have been diagnosed with
septic or other distributive shock for which GIAPREZATM was
approved by the FDA for use as an available treatment option. We stated
in the proposed rule that the applicant continues to maintain that the
use of GIAPREZATM has significant efficacy in improving
blood pressure for patients who have been diagnosed with distributive
shock, while decreasing adrenergic vasopressor usage, thereby,
providing another avenue for therapy in this difficult to treat patient
population. However, we stated we were still concerned that the results
from the clinical trial may be too narrow to accurately represent the
entire patient population that has been diagnosed with septic or other
distributive shock and, therefore, we were concerned that the clinical
trial's results may not adequately demonstrate that
GIAPREZATM is a substantial clinical improvement over
existing therapies for all the patients for whom the treatment option
is indicated. We invited public comments on whether
GIAPREZATM meets the substantial clinical improvement
criterion.
Comment: The applicant submitted comments addressing the concerns
raised by CMS in the proposed rule regarding whether
GIAPREZATM meets the substantial clinical improvement
criterion. With respect to the concern regarding the SOFA scores, the
applicant stated that the data results, which it believes demonstrate
that GIAPREZATM delivers substantial clinical improvement,
are not based solely upon the observed improvements in the SOFA score.
Rather, the applicant explained that SOFA is used to identify patients
at a greater risk of poor outcomes. The applicant stated that the mean
cardiovascular SOFA score at hour 48 showed that there was significant
improvement in the GIAPREZATM group (-1.75) versus the
placebo group (-1.28) (p=0.01), reflecting a higher incidence of
vasopressor discontinuation prior to hour 48 and a reduced
catecholamine dose in the GIAPREZATM group.
The applicant also reiterated that clinical data showing
GIAPREZATM's proven benefit of reducing the need for
background vasopressors constitutes a substantial clinical improvement,
considering the significant toxic effects of catecholamines and
vasopressin administered at higher doses, including cardiac and digital
ischemia; tachyarrhythmias with norepinephrine; cardiac, digital, and
splanchnic ischemia; and ischemic skin lesions with
vasopressin.134 135 136 137 138 139 The applicant further
stated that norepinephrine (a catecholamine) is
[[Page 41341]]
also associated with immunosuppression, which may predispose the
patient to a higher risk of secondary infections.\140\ Other commenters
similarly stated that use of GIAPREZATM reduces the need for
administration of these high-dose vasopressors and helps patients
achieve MAP, with a significant reduction in adverse effects, unlike
with the use of other vasopressors which fail to raise a patient's MAP
and are associated with increases in mortality when administered at
high doses; including cardiac toxicity, necrosis of the skin and distal
extremities, and metabolic dysfunction. Regarding the risk of
thrombosis, the applicant stated that most of the thromboembolic
adverse events were of lower severity and assigned to Grade I or Grade
II. The applicant further pointed out that patients who are diagnosed
with vasodilatory shock are, generally, at a high risk for thrombosis,
and that the FDA labeling and the immediate availability of blood-
thinning agents fully address this potential safety concern.
---------------------------------------------------------------------------
\134\ D[uuml]nser MW, Meier J. Vasopressor hormones in shock-
noradrenaline, vasopressin or angiotensin II: which one will make
the race? J Thorac Dis. 2017;9(7):1843-7.
\135\ D[uuml]nser MW, Hasibeder WR. Sympathetic overstimulation
during critical illness: adverse effects of adrenergic stress. J
Intensive Care Med. 2009;24(5):293-316.
\136\ Russell JA, Rush B, Boyd J. Pathophysiology of septic
shock. Crit Care Clin. 2018;34(1):43 61.
\137\ Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B,
Anguel N, et al. High versus low blood-pressure target in patients
with septic shock. N Engl J Med. 2014;370(17):1583-93.
\138\ Schmittinger CA, Torgersen C, Luckner G, Schroder DC,
Lorenz I, and Dunser MW. Adverse cardiac events during catecholamine
vasopressor therapy: a prospective observational study. Intensive
Care Med. 2012;38(6):950-8.
\139\ Russell JA, Walley KR, Singer J, Gordon AC, H[eacute]bert
PC, Cooper DJ, et al. VASST Investigators. Vasopressin versus
norepinephrine infusion in patients with septic shock. N Engl J Med.
2008;358(9):877-87.
\140\ Stolk RF, van der Poll T, Angus DC, van der Hoeven JG,
Pickkers P, Kox M. Potentially inadvertent immunomodulation:
Norepinephrine use in sepsis. Am J Respir Crit Care Med.
2016;194(5):550-8.
---------------------------------------------------------------------------
In response to our concern that the mortality benefit was not
statistically significant, the applicant stated that the p-values for
the decrease in mortality rates with use of GIAPREZATM may
not demonstrate statistical significance because the clinical trial was
not powered to definitively prove a decrease in mortality rate. The
applicant also contended that the substantial clinical improvement
criterion described in the September 7, 2001 final rule (66 FR 46902)
identifies only a ``reduced mortality rate'' as one of a multitude of
different standards and does not restrict p-values cited to a certain
range to support a new technology add-on payment application
determination. Therefore, the applicant believed that the p-values
support the validity of the new technology add-on payment application
for GIAPREZATM; they do not detract from it. Similarly,
other commenters stated that GIAPREZATM is the only
vasopressor to show a strong trend towards a survival benefit.
The applicant also disagreed with CMS regarding our statement in
the proposed rule that there is not a strong pool of evidence directly
connecting target MAP, lower SOFA scores, and reduced catecholamine
usage with morbidity and mortality. The applicant submitted additional
evidence from the Surviving Sepsis Campaign and international and
European consensus guidelines to demonstrate that maintaining an
adequate MAP is a clinically meaningful benefit affecting morbidity and
mortality. The applicant reiterated that when MAP drops below 60 mmHg,
the human body loses autoregulatory control of blood supply to key
organs,\141\ and even short durations of hypotension (<5 minutes) are
associated with increased serious adverse outcomes, such as myocardial
ischemia and acute kidney injury.\142\ Furthermore, the applicant cited
research demonstrating that a low MAP is associated with an increased
28-day mortality, and stated that an analysis of outcomes in patients
who have been diagnosed with distributive shock demonstrated a clear
relationship between duration and extent of hypotension and ICU
mortality.143 144
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\141\ LeDoux D, Astiz ME, Carpati CM, Rackow EC. Effects of
perfusion pressure on tissue perfusion in septic shock. Crit Care
Med. 2000;28(8):2729-32.
\142\ Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth
RN, et al. Relationship between intraoperative mean arterial
pressure and clinical outcomes after noncardiac surgery: toward an
empirical definition of hypotension. Anesthesiology.
2013;119(3):507-15.
\143\ Johnson AE, Pollard TJ, Shen L, et al. MIMIC-III, a freely
accessible critical care database. Sci data 2016;3:160035.
\144\ Nielsen ND, Zeng F, Gerbasi ME, Oster G, Grossman A,
Shapiro NI. Blood pressure control and clinical outcomes in patients
with distributive shock in an academic intensive care setting. 2018
ISICEM Annual Meeting, Brussels, Belgium (March 20-23, 2018);
Abstract No. A516.
---------------------------------------------------------------------------
The applicant also stated that clinical data show reduced
catecholamine use, a benefit of treatment involving
GIAPREZATM, is associated with less mortality and less
morbidity. The applicant further stated that, according to an analysis
conducted by the applicant of outcomes based on a 50 percent reduction
of the administration of catecholamine doses at 24 hours, those
patients with a 50 percent reduction of administration of
catecholamines doses at 24 hours had a statistically significant
improved survival benefit. Additionally, the applicant indicated that
the catecholamine-sparing effect resulted in significantly fewer
patients experiencing a serious adverse event or a fatal event.
Finally, in response to our concern that the results from the
clinical trial may be too narrow to accurately represent the entire
patient population that has been diagnosed with septic or other
distributive shock and, therefore, may not adequately demonstrate that
GIAPREZATM is a substantial clinical improvement over
existing therapies for all the patients for whom the treatment option
is indicated, the applicant posited that CMS' definition of substantial
clinical improvement in the September 7, 2001 final rule (66 FR 46902)
does not refer to the scope of FDA approval or the patient populations
that that were enrolled in the clinical trial. The applicant asserted
that the multitude of benefits that GIAPREZATM delivers
directly pertaining to the substantial clinical improvement criterion
cannot be assumed to be restricted solely to patients who have been
diagnosed with refractory shock. The applicant specifically summarized
the following improved outcomes:
Reduced mortality rate with use of the device: A promising
trend toward lower mortality was observed in the GIAPREZATM
arm, and more generally, MAP >=65 mmHg is associated with decreased
mortality.\145\
---------------------------------------------------------------------------
\145\ Nielsen ND, Zeng F, Gerbasi ME, Oster G, Grossman A,
Shapiro NI. Blood pressure control and clinical outcomes in patients
with distributive shock in an academic intensive care setting. 2018
ISICEM Annual Meeting, Brussels, Belgium (March 20-23, 2018);
Abstract No. A516.
---------------------------------------------------------------------------
Reduced rate of device-related complications:
GIAPREZATM reduced the need for background vasopressors, the
utilization of which is correlated to serious complications such as
increased digital and limb necrosis,\146\ and kidney injury.\147\
---------------------------------------------------------------------------
\146\ Brown SM, Lanspa MJ, Jones JP, et al. Survival After Shock
Requiring High-Dose Vasopressor Therapy. Chest. 2013;143(3):664-671.
doi:10.1378/chest.12-1106.
\147\ Gordon AC, Mason AJ, Thirunavukkarasu N, et al. Effect of
Early Vasopressin vs Norepinephrine on Kidney Failure in Patients
With Septic Shock. Jama. 2016;316(5):509. doi:10.1001/
jama.2016.10485.
---------------------------------------------------------------------------
Decreased rate of subsequent diagnostic or therapeutic
interventions: In a sub-population analysis of patients suffering from
acute kidney injury, it was found that GIAPREZATM-treated
patients had fewer ICU days, shorter dialysis days, reduced ventilation
usage, and longer survival, compared to placebo.148 149
---------------------------------------------------------------------------
\148\ Khanna A, et al. Angiotensin II for the Treatment of
Vasodilatory Shock Suppl: S14. NEJM. 2017. DOI: 10.1056/
NEJMoa1704154.
\149\ Tumlin JA, Murugan R, Deane AM, et al. Outcomes in
Patients with Vasodilatory Shock and Renal Replacement Therapy
Treated with Intravenous Angiotensin II. Critical Care Medicine.
2018;46(6):949-957. doi:10.1097/ccm.3092.
---------------------------------------------------------------------------
More rapid beneficial resolution of the disease process
treatment: Whereas SOC vasopressors are administered for extended
periods (days), GIAPREZATM has a much shorter time to effect
of only five minutes.
Reduced recovery time: Since low MAP is associated with
high ICU and 28-day mortality and GIAPREZATM achieved target
MAP of 75 mmHg by hour 3 in significantly more patients than the
standard-of-care, while
[[Page 41342]]
reducing the need for other vasopressors, GIAPREZATM may
result in a shorter ICU length of stay and a faster recovery.
Other commenters supported the clinical results and evidence of
GIAPREZATM's meeting the substantial clinical improvement
criterion, and explained that not only did the ATHOS-3 study provide
compelling support for a well-tolerated new therapeutic agent that
demonstrated significant improvements in MAP, it also demonstrated a
strong trend toward improved survival benefit, a catecholamine-sparing
effect, an increase in ICU free days, and a reduction in patients
requiring renal replacement therapy (RRT). To the contrary, another
commenter stated that it, generally, supported CMS' concerns.
Response: We appreciate the additional information and analysis
provided by the applicant and the commenters' input in response to our
concerns regarding substantial clinical improvement. After reviewing
the information submitted by the applicant addressing our concerns
raised in the proposed rule, we agree that GIAPREZATM more
rapidly allows for beneficial resolution of the disease process
treatment with its shorter time to effect of only five minutes, and
that GIAPREZATM has a reduced rate of device-related
complications by reducing the need for background vasopressors, the
utilization of which is correlated to serious complications.
Specifically, we agree with the commenters and the applicant that a
reduction in high-dose SOC catecholamines and vasopressin, which can be
toxic and have numerous adverse effects, constitutes a substantial
clinical improvement. We also agree with the applicant that the FDA-
approved label, which cautions that prophylactic treatment for blood
clots should be used, addresses the potential safety concern of
thrombosis for patients treated with GIAPREZATM. Based on
the data provided by the applicant and consideration of the public
comments we received, we agree with the applicant and the commenters
that GIAPREZATM represents a substantial clinical
improvement over existing technologies because it quickly and
effectively raises MAP while allowing for a reduction in other
vasopressors.
After consideration of the public comments we received, we have
determined that GIAPREZATM meets all of the criteria for
approval for new technology add-on payments. Therefore, we are
approving new technology add-on payments for GIAPREZATM for
FY 2019. Cases involving the use of GIAPREZATM that are
eligible for new technology add-on payments will be identified by ICD-
10-PCS procedure codes XW033H4 and XW043H4.
In its application, the applicant estimated that the average
Medicare beneficiary would require a dosage of 20ng/kg/min administered
as an IV infusion over 48 hours, which would require 2 vials. The
applicant explained that the WAC for one vial is $1,500, with each
episode-of-care costing $3,000 per patient. Under Sec. 412.88(a)(2),
we limit new technology add-on payments 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 a case involving the use of
GIAPREZATM is $1,500 for FY 2019.
h. Cerebral Protection System (Sentinel[supreg] Cerebral Protection
System)
Claret Medical, Inc. submitted an application for new technology
add-on payments for the Cerebral Protection System (Sentinel[supreg]
Cerebral Protection System) for FY 2019. According to the applicant,
the Sentinel Cerebral Protection System is indicated for the use as an
embolic protection (EP) device to capture and remove thrombus and
debris while performing transcatheter aortic valve replacement (TAVR)
procedures. The device is percutaneously delivered via the right radial
artery and is removed upon completion of the TAVR procedure. The De
Novo request for the Sentinel[supreg] Cerebral Protection System was
granted by FDA on June 1, 2017 (DEN160043).
Aortic stenosis (AS) is a narrowing of the aortic valve opening. AS
restricts blood flow from the left ventricle to the aorta and may also
affect the pressure in the left atrium. The most common presenting
symptoms of AS include dyspnea on exertion or decreased exercise
tolerance, exertional dizziness (presyncope) or syncope and exertional
angina. Symptoms experienced by patients who have been diagnosed with
AS and normal left ventricular systolic function rarely occur until
stenosis is severe (defined as valve area is less than 1.0 cm2, the jet
velocity is over 4.0 m/sec, and/or the mean transvalvular gradient is
greater than or equal to 40 mmHg).\150\ AS is a common valvular
disorder in elderly patients. The prevalence of AS increases with age,
and some degree of valvular calcification is present in 75 percent of
patients who are 85 to 86 years old.\151\ TAVR procedures are the
standard of care treatment for patients who have been diagnosed with
severe AS. Patients undergoing TAVR procedures are often older, frail,
and may be affected by multiple comorbidities, implying a significant
risk for thromboembolic cerebrovascular events.\152\ Embolic ischemic
strokes can occur in patients undergoing surgical and interventional
cardiovascular procedures, such as stenting (carotid, coronary,
peripheral), catheter ablation for atrial fibrillation, endovascular
stent grafting, left atrial appendage closure (LAAO), patent formal
ovale (PFO) closure, balloon aortic valvuloplasty, surgical valve
replacement (SAVR), and TAVR. Clinically overt stroke, or silent
ischemic cerebral infarctions, associated with the TAVR procedure, may
result from a variety of causes, including mechanical manipulation of
instruments or other interventional devices used during the procedure.
These mechanical manipulations are caused by, but not limited to, the
placement of a relatively large bore delivery catheter in the aortic
arch, balloon valvuloplasty, valve positioning, valve re-positioning,
valve expansion, and corrective catheter manipulation, as well as use
of guidewires and guiding or diagnostic catheters required for proper
positioning of the TAVR device. The magnitude and timing of embolic
activity resulting from these manipulations was studied by Szeto, et
al.\153\ using a transcranial Doppler, and it was found that embolic
material is liberated throughout the TAVR procedure with some of the
emboli reaching the central nervous system leading to cerebral ischemic
infarctions. Some of the cerebral ischemic infarctions lead to
neurologic injury and clinically apparent stroke. Szeto, et al. also
noted that the rate of silent ischemic cerebral infarctions following
TAVR procedures is estimated to be between 68 and 91
percent.154 155
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\150\ Otto, C., Gaasch, W., ``Clinical manifestations and
diagnosis of aortic stenosis in adults,'' In S. Yeon (Ed.), 2016,
Available at: https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-aortic-stenosis-in-adults.
\151\ Lindroos, M., et al., ``Prevalence of aortic valve
abnormalities in the elderly: An echocardiographic study of a random
population sample,'' J Am Coll Cardio, 1993, vol. 21(5), pp. 1220-
1225.
\152\ Giustino, G., et al., ``Neurological Outcomes With Embolic
Protection Devices in Patients Undergoing Transcatheter Aortic Valve
Replacement,'' J Am Coll Cardio, CARDIOVASCULAR INTERVENTIONS, 2016,
vol. 9(20).
\153\ Szeto, W.Y., et al., ``Cerebral Embolic Exposure During
Transfemoral and Transapical Transcatheter Aortic Valve
Replacement,'' J Card Surg, 2011, vol. 26, pp. 348-354.
\154\ Gupta, A., Giambrone, A.E., Gialdini, G., et al., ``Silent
brain infarction and risk of future stroke: a systematic review and
meta-analysis,'' Stroke, 2016, vol. 47, pp. 719-25.
\155\ Mokin, M., Zivadinov, R., Dwyer, M.G., Lazar, R.M.,
Hopkins, L.N., Siddiqui, A.H., ``Transcatheter aortic valve
replacement: perioperative stroke and beyond,'' Expert Rev
Neurother, 2017, vol. 17, pp. 327-34.
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[[Page 41343]]
The TAVR procedure is a minimally invasive procedure that does not
involve open heart surgery. During a TAVR procedure the prosthetic
aortic valve is placed within the diseased native valve. The prosthetic
valve then becomes the functioning aortic valve. As previously
outlined, stroke is one of the risks associated with TAVR procedures.
According to the applicant, the risk of stroke is highest in the early
post-procedure period and, as previously outlined, is likely due to
mechanical factors occurring during the TAVR procedure.\156\ Emboli can
be generated as wire-guided devices are manipulated within
atherosclerotic vessels, or when calcified valve leaflets are traversed
and then crushed during valvuloplasty and subsequent valve
deployment.\157\ Stroke rates in patients evaluated 30 days after TAVR
procedures range from 1.0 percent to 9.6 percent \158\, and have been
associated with increased mortality. Additionally, new ``silent
infarcts,'' assessed via diffusion-weighted magnetic resonance imaging
(DW-MRI), have been found in a majority of patients after TAVR
procedures.\159\
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\156\ Nombela-Franco, L., et al., ``Timing, predictive factors,
and prognostic value of cerebrovascular events in a large cohort of
patients undergoing transcatheter aortic valve implantation,''
Circulation, 2012, vol. 126(25), pp. 3041-53.
\157\ Freeman, M., et al., ``Cerebral events and protection
during transcatheter aortic valve replacement,'' Catheterization and
Cardiovascular Interventions, 2014, vol. 84(6), pp. 885-896.
\158\ Haussig, S., Linke, A., ``Transcatheter aortic valve
replacement indications should be expanded to lower-risk and younger
patients,'' Circulation, 2014. vol. 130(25), pp. 2321-31.
\159\ Kahlert, P., et al., ``Silent and apparent cerebral
ischemia after percutaneous transfemoral aortic valve implantation:
a diffusion-weighted magnetic resonance imaging study,''
Circulation, 2010, vol. 121(7), pp. 870-8.
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As stated earlier, the De Novo request for the Sentinel[supreg]
Cerebral Protection System was granted by FDA on June 1, 2017. The FDA
concluded that this device should be classified into Class II (moderate
risk). Effective October 1, 2016, ICD-10-PCS Section ``X'' code X2A5312
(Cerebral embolic filtration, dual filter in innominate artery and left
common carotid artery, percutaneous approach) was approved to identify
cases involving TAVR procedures using the Sentinel[supreg] Cerebral
Protection System.
As discussed earlier, if a technology meets all three of the
substantial similarity 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, the Sentinel[supreg] Cerebral Protection
System device is inserted at the beginning of the TAVR procedure, via a
small tube inserted through a puncture in the right wrist. Next, using
a minimally invasive catheter, two small filters are placed in the
brachiocephalic and left common carotid arteries. The filters collect
debris, preventing it from becoming emboli, which can travel to the
brain. These emboli, if left uncaptured, can cause cerebral ischemic
lesions, often referred to as silent ischemic cerebral infarctions,
potentially leading to cognitive decline or clinically overt stroke. At
the completion of the TAVR procedure, the filters, along with the
collected debris, are removed. The applicant stated that there are no
other similar products for commercial sale available in the United
States for cerebral protection during TAVR procedures. Two
neuroprotection devices, the TriguardTM Cerebral Protection
Device (Keystone Heart, Herzliya Pituach, Israel) and the Embrella
Embolic DeflectorTM System (Edwards Lifesciences, Irvine,
CA) are used in Europe. These devices work by deflecting embolic debris
distally, rather than capturing and removing debris with filters.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, as stated earlier, the
Sentinel[supreg] Cerebral Protection System is an EP device used to
capture and remove thrombus and debris while performing TAVR
procedures. Therefore, potential cases representing patients who may be
eligible for treatment involving this device would map to the same MS-
DRGs as cases involving TAVR procedures.
With respect to the third criterion, 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, according to the
applicant, this technology will be used to treat patients who have been
diagnosed with severe aortic valve stenosis who are eligible for a TAVR
procedure. The applicant asserted that there are currently no approved
alternative treatment options for cerebral protection during TAVR
procedures, and the Sentinel[supreg] Cerebral Protection System is the
first and only embolic protection device for use during TAVR procedures
and, therefore, meets the newness criterion. The applicant also
asserted that the device meets the newness criterion, as evidenced by
the FDA's granting of the De Novo request and there was no predicate
device.
Based on the above, we stated in the proposed rule that it appears
that the Sentinel[supreg] Cerebral Protection System is not
substantially similar to other existing technologies. We invited public
comments on whether the Sentinel[supreg] Cerebral Protection System is
substantially similar to any existing technology and whether it meets
the newness criterion.
Comment: Several commenters agreed with CMS' assessment that the
Sentinel[supreg] Cerebral Protection System is not substantially
similar to other existing technologies.
Response: After consideration of the public comments we received,
we believe the Sentinel[supreg] Cerebral Protection System is not
substantially similar to other existing technologies because it is the
only neuro protective device available in the U.S. that has been
granted a De Novo request by the FDA. Therefore, we believe that the
Sentinel[supreg] Cerebral Protection System meets the newness
criterion.
The applicant conducted the following analysis to demonstrate that
the technology meets the cost criterion. The applicant searched the FY
2016 MedPAR file for cases with the following ICD-10-CM procedure codes
to identify cases involving TAVR procedures, which are potential cases
representing patients who may be eligible for treatment involving use
of the Sentinel[supreg] Cerebral Protection System: 02RF37Z
(Replacement of aortic valve with autologous tissue substitute,
percutaneous approach); 02RF38Z (Replacement of aortic valve with
zooplastic tissue, percutaneous approach); 02RF3JZ (Replacement of
aortic valve with synthetic substitute, percutaneous approach); 02RF3KZ
(Replacement of aortic valve with nonautologous tissue substitute,
percutaneous approach); 02RF37H (Replacement of aortic valve with
autologous tissue substitute, transapical, percutaneous approach);
02RF38H (Replacement of aortic valve with zooplastic tissue,
transapical, percutaneous approach); 02RF3JH (Replacement of aortic
valve with synthetic substitute, transapical, percutaneous approach);
and 02RF3KH (Replacement of aortic valve with nonautologous tissue
substitute, transapical, percutaneous approach). This process resulted
in 26,012 potential cases. The applicant limited its search to MS-DRG
266 (Endovascular Cardiac Valve Replacement with MCC) and MS-DRG
[[Page 41344]]
267 (Endovascular Cardiac Valve Replacement without MCC) because these
two MS-DRGs accounted for 97.4 percent of the total cases identified.
Using the 26,012 identified cases, the applicant determined that
the average unstandardized case-weighted charge per case was $211,261.
No charges were removed for the prior technology because the device is
used to capture and remove thrombus and debris while performing TAVR
procedures. The applicant then standardized the charges, but did not
inflate the charges. The applicant then added charges for the new
technology to the average case-weighted standardized charges per case
by taking the cost of the device and dividing the amount by the CCR of
0.332 for implantable devices from the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38103). The applicant calculated a final inflated average case-
weighted standardized charge per case of $187,707 and a Table 10
average case-weighted threshold amount of $170,503. Because the final
inflated average case-weighted standardized charge per case exceeded
the average case-weighted threshold amount, the applicant maintained
that the technology met the cost criterion. We invited public comments
on whether the Sentinel[supreg] Cerebral Protection System meets the
cost criterion.
Comment: The applicant reiterated that the Sentinel[supreg]
Cerebral Protection System meets the cost criterion.
Response: We appreciate the applicant's input. After consideration
of the public comment we received and reviewing the cost data and data
analysis submitted by the applicant, we agree that the Sentinel[supreg]
Cerebral Protection System meets the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that the Sentinel[supreg] Cerebral Protection System
represents a substantial clinical improvement over existing
technologies because it is the first and only cerebral embolic
protection device commercially available in the United States for use
during TAVR procedures. The applicant stated that the data below shows
that the Sentinel[supreg] Cerebral Protection System effectively
captures brain bound embolic debris and significantly improves clinical
outcomes (that is, stroke) beyond the current standard of care, that
is, TAVR procedures with no embolic protection.
The applicant provided the results of four key studies: (1) The
SENTINEL[supreg] study\160\ conducted by Claret Medical, Inc.; (2) the
CLEAN-TAVI trial \161\; (3) the Ulm real-world registry \162\; and (4)
the MISTRAL-C study.\163\ The applicant reported that the
SENTINEL[supreg] study was a prospective, single blind, multi-center,
randomized study using the Sentinel[supreg] Cerebral Protection System
which enrolled patients who had been diagnosed with severe symptomatic
calcified native aortic valve stenosis indicated for a TAVR procedure.
A total of 363 patients at 19 centers in the United States and Germany
were randomized across 3 arms (Safety, Test, and Control) in a 1:1:1
fashion. According to the applicant, evaluations performed for patients
in each arm were as follows:
---------------------------------------------------------------------------
\160\ Kapadia, S., Kodali, S., Makkar, R., et al., ``Protection
against cerebral embolism during transcatheter aortic valve
replacement,'' JACC, 2017, vol. 69(4), pp. 367-377.
\161\ Haussig, S., Mangner, N., Dwyer, M.G., et al., ``Effect of
a Cerebral Protection Device on Brain Lesions Following
Transcatheter Aortic Valve Implantation in Patients With Severe
Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial,'' JAMA,
2016, vol. 316, pp. 592-601.
\162\ Seeger, J., et al., ``Cerebral Embolic Protection During
Transfemoral Aortic Valve Replacement Significantly Reduces Death
and Stroke Compared With Unprotected Procedures,'' JACC Cardiovasc
Interv, 2017.
\163\ Mieghem, Van, et al., ``Filter-based cerebral embolic
protection with transcatheter aortic valve implantation: the
randomized MISTRAL-C trial,'' Eurointervention, 2016, vol. 12(4),
pp. 499-507.
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Safety Arm patients who underwent a TAVR procedure
involving the Sentinel[supreg] Cerebral Protection System--Patients
enrolled in this arm of the study received safety follow-up at
discharge, at 30 days and 90 days post-procedure; and neurological
evaluation at baseline, discharge, 30 days and 90 days (only in the
case of a stroke experienced less than or equal to 30 days) post-
procedure. The Safety Arm patients did not undergo MRI or
neurocognitive assessments.
Test Arm patients who underwent a TAVR procedure involving
the Sentinel[supreg] Cerebral Protection System--Patients enrolled in
this arm of the study underwent safety follow-up at discharge, at 30
days and 90 days post-procedure; MRI assessment for efficacy at
baseline, 2 to 7 days and 30 days post-procedure; neurological
evaluation at baseline, discharge, 30 days and 90 days (only in the
case of a stroke experienced less than or equal to 30 days) post-
procedure; neurocognitive evaluation at baseline, 2 to 7 days
(optional), 30 days and 90 days post-procedure; Quality of Life
assessment at baseline, 30 days and 90 days; and histopathological
evaluation of debris captured in the Sentinel[supreg] Cerebral
Protection System's device filters.
Control Arm patients who underwent a TAVR procedure only--
Patients enrolled in this arm of the study underwent safety follow-up
at discharge, at 30 days and 90 days post-procedure; MRI assessment for
efficacy at baseline, 2 to 7 days and 30 days post-procedure;
neurological evaluation at baseline, discharge, 30 days and 90 days
(only in the case of a stroke experienced less than or equal to 30
days) post-procedure; neurocognitive evaluation at baseline, 2 to 7
days (optional), 30 days and 90 days post-procedure; and Quality of
Life assessment at baseline, 30 days and 90 days.
The primary safety endpoint was occurrence of major adverse cardiac
and cerebrovascular events (MACCE) at 30 days compared with a
historical performance goal. MACCE was defined as follows: All causes
of death; all strokes (disabling and nondisabling, Valve Academic
Research Consortium-2 (VARC-2)); and acute kidney injury (stage 3,
VARC-2). The point estimate for the historical performance goal for the
primary safety endpoint at 30 days post-TAVR procedure was derived from
a review of published reports of 30-day TAVR procedure outcomes. The
VARC-2 established an independent collaboration between academic
research organizations and specialty societies (cardiology and cardiac
surgery) in the United States and Europe to create consistent endpoint
definitions and consensus recommendations for implementation in TAVR
procedure clinical research.\164\
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\164\ Leon, M.B., Piazza, N., Nikolsky, E., et al.,
``Standardized endpoint definitions for transcatheter aortic valve
implantation clinical trials: a consensus report from the Valve
Academic Research Consortium,'' European Heart Journal, 2011, vol.
32(2), pp. 205-217, doi:10.1093/eurheartj/ehq406.
---------------------------------------------------------------------------
The applicant reported that results of the SENTINEL[supreg] study
demonstrated the following:
The rate of MACCE was numerically lower than the control
arm, 7.3 percent versus 9.9 percent, but was not statistically
significant from that of the control group (p=0.41).
New lesion volume was 178.0 mm\3\ in control patients and
102.8 mm\3\ in the Sentinel[supreg] Cerebral Protection System device
arm (p=0.33). A post-hoc multi-variable analysis identified preexisting
lesion volume and valve type as predictors of new lesion volume.
Strokes experienced at 30 days were 9.1 percent in control
patients and 5.6 percent in patients treated with the Sentinel[supreg]
Cerebral Protection System devices (p=0.25). Neurocognitive function
was similar in control patients
[[Page 41345]]
and patients treated with the Sentinel[supreg] Cerebral Protection
System devices, but there was a correlation between lesion volume and
neurocognitive decline (p=0.0022).
Debris was found within filters in 99 percent of patients
and included thrombus, calcification, valve tissue, artery wall, and
foreign material.
The applicant also noted that the post-hoc analysis of
these data demonstrated that there was a 63 percent reduction in 72-
hour stroke rate (compared to control), p=0.05.
According to the applicant, the CLEAN-TAVI (Claret Embolic
Protection and TAVI) trial, was a small, randomized, double-blind,
controlled trial. The trial consisted of 100 patients assigned to
either EP (n=50) with the Claret Medical, Inc. device (the
Sentinel[supreg] Cerebral Protection System) or to no EP (n=50).
Patients were all treated with femoral access and self-expandable (SE)
devices. The study endpoint was the number of brain lesions at 2 days
post-procedure versus baseline. Patients were evaluated with DW-MRI at
2 and 7 days post-TAVR procedure. The mean age of patients was 80 years
old; 43 percent were male. The study results showed that patients
treated with the Sentinel[supreg] Cerebral Protection System had a
lower number of new lesions (4.00) than patients in the control group
(10.0); (p<0.001).
According to the applicant, the single-center Ulm study, a large
propensity matched trial, with 802 consecutive patients, occurred at
the University of Ulm between 2014 and 2016. The first 522 patients
(65.1 percent of patients) underwent a TAVR procedure without EPs, and
the subsequent 280 patients (34.9 percent of patients) underwent a TAVR
procedure with EP involving the Sentinel[supreg] Cerebral Protection
System. For both arms of the study, a TAVR procedure was performed in
identical settings except without cerebral EP, and neurological follow-
up was performed within 7 days post-procedure. The primary endpoint was
a composite of all-cause mortality or all-stroke according to the VARC-
2 criteria within 7 days. The authors who documented the study noted
the following:
Patient baseline characteristics and aortic valve
parameters were similar between groups, that both filters of the device
were successfully positioned in 280 patients, all neurological follow-
up was completed by the 7th post-procedure date, and that propensity
score matching was performed to account for possible confounders.
Results indicated a decreased rate of disabling and
nondisabling stroke at 7 days post-procedure was seen in those patients
who were treated with the Sentinel[supreg] Cerebral Protection System
device versus control patients (1.6 percent versus 4.6 percent,
p=0.03).
At 48 hours, stroke rates were lower with patients treated
with the Sentinel[supreg] Cerebral Protection System device versus
control patients (1.1 percent versus 3.6 percent, p=0.03).
In multi-variate analysis, TAVR procedures performed
without the use of a EP device was found to be an independent predictor
of stroke within 7 days (p=0.04).
The aim of the MISTRAL-C study was to determine if the
Sentinel[supreg] Cerebral Protection System affects new brain lesions
and neurocognitive performance after TAVR procedures. The study was
designed as a multi-center, double-blind, randomized trial enrolling
patients who were diagnosed with symptomatic severe aortic stenosis and
1:1 randomization to TAVI patients treated with or without the
Sentinel[supreg] Cerebral Protection System. From January 2013 to
August 2015, 65 patients were enrolled in the study. Patients ranged in
age from 77 years old to 86 years old, 15 (47 percent) were female and
17 (53 percent) were male patients randomized to the Sentinel[supreg]
Cerebral Protection System group and 16 (49 percent) were female and 17
(51 percent) were male patients randomized to the control group. There
were 3 mortalities between 5 days and 6 months post-procedure for the
Sentinel[supreg] Cerebral Protection System group. There were no
strokes reported for the Sentinel[supreg] Cerebral Protection System
group. There were 7 mortalities between 5 days and 6 months post-
procedure for the control group. There were 2 strokes reported for the
control group. Patients underwent DW-MRI and neurological examination,
including neurocognitive testing 1 day before and 5 to 7 days after
TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57
percent of TAVI patients treated with the Sentinel[supreg] Cerebral
Protection System and 80 percent for the group of TAVI patients treated
without the Sentinel[supreg] Cerebral Protection System. New brain
lesions were found in 78 percent of the patients with follow-up MRI.
According to the applicant, patients treated with the Sentinel[supreg]
Cerebral Protection System had numerically fewer new lesions and a
smaller total lesion volume (95 mm3 versus 197 mm3). Overall, 27
percent of the patients treated with the Sentinel[supreg] Cerebral
Protection System and 13 percent of the patients treated in the control
group had no new lesions. Ten or more new brain lesions were found only
in the patients treated in the control group (20 percent in the control
group versus 0 percent in the Sentinel[supreg] Cerebral Protection
System group, p=0.03). Neurocognitive deterioration was present in 4
percent of the patients treated with the Sentinel[supreg] Cerebral
Protection System versus 27 percent of the patients treated without
(p=0.017). The filters captured debris in all of the patients treated
with Sentinel[supreg] Cerebral Protection System device.
In the Ulm study, the primary outcome was a composite of all-cause
mortality or stroke at 7 days, and occurred in 2.1 percent of the
Sentinel[supreg] Cerebral Protection System group versus 6.8 percent of
the control group (p=0.01, number needed to treat (NNT)=21). Use of the
Sentinel[supreg] Cerebral Protection System device was associated with
a 2.2 percent absolute risk reduction in mortality with NNT 45.
Composite endpoint of major adverse cardiac and cerebrovascular events
(MACCE) was found in 2.1 percent of those patients undergoing a TAVR
procedure with the use of the Sentinel[supreg] Cerebral Protection
System device versus 7.9 percent in the control group (p=0.01). Similar
but statistically nonsignificant trends were found in the
SENTINEL[supreg] study, with rate of MACCE of 7.3 percent in the
Sentinel[supreg] Cerebral Protection System group versus 9.9 percent in
the control group (p=0.41).
The applicant reported that the four studies discussed above that
evaluated the Sentinel[supreg] Cerebral Protection System device have
limitations because they are either small, nonrandomized and/or had
significant loss to follow-up. In the proposed rule, we stated that a
meta-analysis of EP device studies, the majority of which included use
of the Sentinel[supreg] Cerebral Protection System device, found that
use of cerebral EP devices was associated with a nonsignificant
reduction in stroke and death.\165\ After further review, we realize we
misquoted the statement made in the study. The meta-analysis from 2016
actually concluded the following: ``Although the differences in overt
stroke were not significant, use of intraoperative EP was associated
with a numeric stroke reduction, which may become significant in larger
RCTs powered for hard endpoints.'' We note that we provide an updated
discussion of this meta-analysis in our response to comments below.
---------------------------------------------------------------------------
\165\ Giustino, G., et al., ``Neurological Outcomes With Embolic
Protection Devices in Patients Undergoing Transcatheter Aortic Valve
Replacement,'' Journal of the American College of Cardiology:
Cardiovascular Interventions, 2016, vol. 9(20), pp. 2124-2133.
---------------------------------------------------------------------------
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20338), we stated
[[Page 41346]]
we were concerned that the use of cerebral protection devices may not
be associated with a significant reduction in stroke and death. We
noted that the SENTINEL[supreg] study, although a randomized study, did
not meet its primary endpoint, as illustrated by nonstatistically
significant reduction in new lesion volume on MRI or nondisabling
strokes within 30 days (5.6 percent stroke rate in the Sentinel[supreg]
Cerebral Protection System device group versus a 9.1 percent stroke
rate in the control group at 30 days; p=0.25). We also noted that only
with a post-hoc analysis of the SENTINEL[supreg] study data were
promising trends noted, where the device use was associated with a 63
percent reduction in stroke events at 72 hours (p=0.05). Additionally,
although there was a statistically significant difference between the
patients treated with and without cerebral embolic protection in the
composite of all-cause mortality or stroke at 7 days, the Ulm study was
a nonrandomized study and propensity matching was performed during
analyses. We stated we are concerned that studies involving the
Sentinel[supreg] Cerebral Protection System may be inconclusive
regarding whether the device represents a substantial clinical
improvement for patients undergoing TAVR procedures. We also stated we
are concerned that the SENTINEL[supreg] studies did not show a
substantial decrease in neurological complications for patients
undergoing TAVR procedures. We invited public comments on whether the
Sentinel[supreg] Cerebral Protection System meets the substantial
clinical improvement criterion.
Comment: The applicant submitted comments in response to the
concerns we raised in the proposed rule. Specifically, in the proposed
rule, we noted the following:
The SENTINEL[supreg] study, although a randomized study,
did not meet its primary endpoint as illustrated by non-statistically
significant reduction in new lesion volume on MRI or non-disabling
strokes within 30 days (5.6 percent stroke rate in the Sentinel[supreg]
Cerebral Protection System device group versus a 9.1 percent stroke
rate in the control group at 30 days; p=0.25).
Only with a post-hoc analysis of the SENTINEL[supreg]
study data were promising trends noted where the device use was
associated with a 63 percent reduction in stroke events at 72 hours
(p=0.05).
With regard to the above, the applicant responded and explained the
following with respect to the SENTINEL[supreg] trial:
The SENTINEL[supreg] trial's success criteria were
designed with two primary efficacy endpoints that were a surrogate
imaging endpoint combination of: (1) Observed reduction of 30 percent
in new lesion volume on MRI; and (2) statistical reduction in new
lesion volume on MRI. The applicant indicated that the trial was
successful in demonstrating a 42 percent reduction in new lesion
volume, but as CMS pointed out, it did not, on its own, reach
statistical significance, which the applicant stated was because of, in
part, the surrogate nature of the endpoint as well as the higher than
expected variability. The applicant noted that the variability resulted
from the following sources: (1) Variability in the MRI data, in part
due to the variability in the allowed time window of 2 to 7 days,
logistics of scheduling follow-up MRIs within this time window for
elderly patients, and the transient nature of the DW-MRI signal over
time which made the signal decay rate very noisy; (2) variability due
to multiplicity (total of four types) of TAVR valve types (including
balloon expandable and self-expanding) introduced mid-course into the
trial (the trial was powered for only two types of TAVR valves
originally), which behaved differently and required different
procedural parameters in terms of pre-dilatation or post-dilatation and
repositioning; and (3) variability in the patient baseline lesion
volumes burden or white matter disease, which was unaccounted for
because this was new science generated as a result of this trial \166\
that has now been published, and a related manuscript \167\ submitted
and in review.
---------------------------------------------------------------------------
\166\ Lazar, R., et al., ``Neurocognition and Cerebral Lesion
Burden in High-Risk Patients Before Undergoing Transcatheter Aortic
Valve Replacement: Insights From the SENTINEL Trial,'' J Cardiovasc
Interv, February 26, 2018, vol. 11(4), pp. 384-392.
\167\ Dwyer, M., et al., ``Pre-procedural white matter lesion
burden predicts MRI outcomes in transcatheter aortic valve
replacement (TAVR): The SENTINEL Trial.''
---------------------------------------------------------------------------
In retrospect, the SENTINEL[supreg] trial was underpowered
for the surrogate efficacy endpoint. However, according to the
applicant, a meta-analysis of all three randomized trials of Claret
dual-filter technology in TAVR using MRI endpoints by Latib, et al.
(2017), which had an increased number of patients available for
analysis, did show statistically significant reduction in new lesion
volume.
The primary safety endpoint for the SENTINEL[supreg] trial
was occurrence of all Major Adverse Cardiac and Cerebrovascular Events
(MACCE) at 30 days compared to a historical performance goal, and the
Sentinel[supreg] Cerebral Protection System met this endpoint for
noninferiority (p<0.001) and superiority (p=0.0026)
The SENTINEL[supreg] trial was not designed to be powered
to show a statistically significant reduction in procedural stroke
between trial arms at 30-days; therefore, it did not reach statistical
significance. However, according to the applicant, investigators were
encouraged by the trend to lower rates of stroke in the
Sentinel[supreg] arms (5.6 percent) as compared to Control (9.1
percent) at 30-days. Additionally, more than 60 percent of ischemic
neurological events in TAVR occur during the acute peri procedural
phase as a result of thromboembolic debris released from manipulation
of TAVR and accessory devices in a heavily atherosclerotic vascular and
valvular structures.\168\ As a result, the SENTINEL[supreg]
investigators and FDA Advisory Panel at large were, according to the
applicant, keen to temporally analyze the stroke data in two phases
(acute and subacute). The applicant stated that this post-hoc analysis
demonstrated that the acute phase is the critical period where cerebral
protection offers the most protection against any incidence of stroke
by demonstrating a significant treatment effect of 63 percent at <72
hours. This window was less confounded by events that may occur later
in the subacute phase after a TAVR procedure as a result of new onset
AF or suboptimal anticoagulation/antiplatelet regimens.
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\168\ Kapadia, S., et al., Circ Cardiovasc Interv, September
2016, vol. 9(9), pp. 1-10.
---------------------------------------------------------------------------
Response: We appreciate the applicant's input and have considered
this information in our determination below.
Comment: With regard to CMS' concern in the proposed rule that the
use of cerebral protection devices may not be associated with a
significant reduction in stroke and death (as noted previously, we have
corrected our statement from the proposed rule on the findings of the
meta-analysis on which this statement was based), the applicant stated
that the meta-analysis of 180 randomized patients from 3 small
randomized trials from 2016 did not include the results from the
SENTINEL[supreg] randomized trial, which were not available at the
time, but the authors of this study (Giustino, G., et al.\169\)
subsequently published in 2017 an updated systematic review and meta-
analysis of 5 randomized trials totaling 625 patients (in which the
SENTINEL[supreg] trial contributed 363 patients to the 625
[[Page 41347]]
patients in the 2017 meta-analysis). The 2017 Guistino, G., et al.
meta-analysis evaluated EP during TAVR, including SENTINEL[supreg], and
showed that at 30 days EP was associated with a lower risk of death or
stroke on relative (6.4 percent versus 10.8 percent; RR: 0.57; 95
percent CI: 0.33 to 0.98; p=0.04; I2=0 percent) and absolute (ARD: -4.4
percent; 95 percent CI: -9.0 percent to -0.1 percent; NNT=22) terms
(that is, for every 22 patients assigned to an EP device, 1 death or
stroke event may be averted). According to the applicant, these
findings suggest that EP may be a clinically relevant adjunctive
strategy in patients undergoing TAVR procedures. The applicant noted
that in the updated analysis, the authors of Giustino, G., et al.
stated that, in conclusion, the totality of the data suggests that use
of EP during TAVR appears to be associated with a significant reduction
in death or stroke.
---------------------------------------------------------------------------
\169\ Giustino, G., Sabato, S., Mehran, R., Faggioni, M., and
Dangas, G., ``Cerebral Embolic Protection During TAVR, A Clinical
Event Meta-Analysis,'' JACC, 2017, vol. 69, pp. 465-66.
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The applicant stated that an independent group recently published a
similar meta-analysis of the same 5 randomized trials in the Journal of
Thoracic Disease \170\ and reached the same conclusion as Giustino, G.,
et al. The applicant indicated that a third meta-analysis has been
accepted that is in press, which includes 5 randomized and prospective
observational studies, totaling 1,160 TAVR patients, in which cerebral
embolic protection was used in 661.\171\ According to the applicant,
the authors found that the risk of strokes within the first week of
TAVR was significantly lower in the CPD group [0.56(95 percent CI 0.33-
0.96)]; p=0.034. The authors concluded that TAVR with CPD is associated
with decreased strokes within 1 week of follow-up and not associated
with an increase in peri-procedural adverse events. The applicant
stated that it is important to note that the effectiveness of cerebral
protection devices is during the procedure and best measured within a
week or less of the procedure. The applicant further noted that events
occurring after 1 week, up to and beyond 30 days are often associated
with new-onset atrial fibrillation associated with the valve implant,
inadequate anticoagulation regimen, and unrelated background risk.
---------------------------------------------------------------------------
\170\ Wang N and Phan K, ``Cerebral protection devices in
transcatheter aortic valve replacement: a clinical meta-analysis of
randomized controlled trials'', J Thorac Dis, 2018;10(3):1927-1935.
\171\ Mohananey D, et al. ``Safety and Efficacy of Cerebral
Protection Devices in Transcatheter Aortic Valve Replacement: A
Clinical End-points Meta-analysis.'' Cardiovasc Revasc Med, 2018 Feb
16.
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Response: In the comment above, the applicant focused on the 2017
meta-analysis from Giustino, G., et al.\172\ and stated, as indicated
in the summary above, that the authors concluded that the totality of
the data suggests that use of EP during TAVR appears to be associated
with a significant reduction in death or stroke.
---------------------------------------------------------------------------
\172\ Giustino, G., Sabato, S., Mehran, R., Faggioni, M., and
Dangas, G., ``Cerebral Embolic Protection During TAVR, A Clinical
Event Meta-Analysis,'' JACC, 2017, vol. 69, pp. 465-66.
---------------------------------------------------------------------------
However, in April 2018, based on updated data, the authors for the
2017 Giustino, G., et al. publication updated their conclusion of the
2017 meta-analysis and stated the following: ``In conclusion, the
totality of the data suggests that use of EP during TAVR appears to be
associated with a nonsignificant trend towards reduction in death or
stroke.'' Therefore, we continue to be concerned that the use of
cerebral protection devices may not be associated with a significant
reduction in stroke and death beyond 7 days (which is the focus of the
meta-analysis). However, we note, as discussed below, the applicant has
responded with additional information regarding the reduction in death
or stroke within 7 days.
Comment: In response to CMS' concerns as indicated in the proposed
rule that the studies involving the Sentinel[supreg] Cerebral
Protection System may be inconclusive regarding whether the device
represented a substantial clinical improvement for patients undergoing
TAVR procedures, the applicant referenced the academic study from the
University of Ulm in Germany, which was independently funded and
conducted, and published by Seeger, J., et al.\173\ The applicant
stated that this study is an example of performance in routine clinical
use, as investigators used the Sentinel[supreg] Cerebral Protection
System in 280 consecutive TAVR patients and compared results in a
propensity-score analysis to recent unprotected patients from the same
institution, with the same operators, and the same independent
neurologist who adjudicated all the neurological events. According to
the applicant, this approach gives information about performance in a
broad set of patients seen in clinical practice, unrestricted by
inclusion and exclusion criteria of randomized trials. The applicant
further explained that the academic study from the University of Ulm
used propensity-score analysis based on an optimal matching attempt by
adjusting/matching up to 14 key confounders after performing a
comprehensive multivariable analysis by stepwise forward regression to
evaluate independent predictors of clinical events. The applicant
explained that propensity-score analyses are well accepted in the
interventional cardiology and medical device community at large. The
applicant further stated that propensity-score analyses are an
alternative when randomized trials are not possible, practical, or
ethical. For example, according to the applicant, in the case of
cerebral embolic protection, investigators have struggled with ethical
and moral imperatives of randomizing when many patients do not want to
enter a randomized trial when they know that the device is already
commercially available.
---------------------------------------------------------------------------
\173\ Seeger, J., et al., ``Cerebral Embolic Protection During
Transfemoral Aortic Valve Replacement Significantly Reduces Death
and Stroke Compared With Unprotected Procedures,'' JACC Cardiovasc
Interv, 2017.
---------------------------------------------------------------------------
The applicant added that it believed that the 1 to 7 day time
period is the most appropriate for evaluation of cerebral protection
efficacy because it is difficult to accurately diagnose neurological
impairment immediately post-operatively when the patient is recovering
from the effects of anesthesia and some sequelae of embolic events can
take time to evolve and be diagnosed, and conversely time points later
than a week or so are confounded by strokes unrelated to embolic events
during the index procedure, such as New Onset of Atrial Fibrillation
(NOAF), suboptimal concomitant anti-platelet/anticoagulation
medication, and other comorbid history of the patients.
The applicant noted that, in the past few months, a number of TAVR
centers have begun to share their data from routine practice using the
Sentinel[supreg] Cerebral Protection System in TAVR procedures, which
are in line with the clinical event reductions seen in the
aforementioned trials. The applicant provided information from the
following TAVR centers:
Erasmus Medical Center (Rotterdam, The Netherlands)
demonstrated comprehensive and systematic analysis of 747 TAVR patients
treated with or without the use of the Sentinel[supreg] EP with
independent neurological adjudication of the events. The applicant
noted that, as presented by Nicolas van Mieghem, MD at the Joint
Interventional Meeting (JIM) 2018 and Cardiovascular Research
Technologies (CRT) 2018 conferences in February and March, there was an
80 percent relative risk reduction from 5 percent (23/453) to 1 percent
(3/294) for all-stroke + TIA at 3 days with use of Sentinel[supreg]
(p<0.01).
Data from Cedars-Sinai Medical Center in Los Angeles, CA
from a
[[Page 41348]]
comprehensive and systematic analysis of 419 TAVR patients treated with
or without the use of the Sentinel[supreg] EP results show: 78 percent
relative risk reduction from 6.3 percent (8/128) to 1.4 percent (4/291)
for all-stroke at 7 days with use of Sentinel[supreg] (HR 0.22 (95
percent CI: 0.06 to 0.74, p=0.01).
Data from Pinnacle Health (Harrisburg, PA) as presented by
Hemal Gada, MD at the CMS New Technology Town Hall meeting, February
2018, demonstrated a reduction from 10 percent (7/69) 7-day stroke rate
without the use of the Sentinel[supreg] to 0 percent (0/53) with the
use of the Sentinel[supreg], as of the time at the Town Hall
presentation in February.
The applicant concluded that the clinical evidence is robust,
consistent, reliable, and repeatable and that the totality of the data
shows that Sentinel[supreg] Cerebral Protection System represents a
substantial clinical improvement for patients undergoing TAVR
procedures.
Response: We appreciate the applicant's response to our concerns
and its additional input. We agree with the applicant that the 1 to 7
day time period is the most appropriate for evaluation of cerebral
protection efficacy. Specifically, as the commenter noted, it is
difficult to accurately diagnose neurological impairment immediately
post-operatively when the patient is recovering from the effects of
anesthesia and some sequelae of embolic events can take time to evolve
and be diagnosed. Conversely, time points later than 7 days are
confounded by strokes unrelated to embolic events during the index
procedure, such as NOAF, suboptimal concomitant anti-platelet/
anticoagulation medication, and other comorbid history of the patients.
We believe that the use of propensity matching in the Ulm study
supports the statistical difference of all-cause mortality or stroke at
7 days. Specifically, as stated above, in the Ulm study, the primary
outcome was a composite of all-cause mortality or stroke at 7 days, and
occurred in 2.1 percent of the Sentinel[supreg] Cerebral Protection
System group versus 6.8 percent of the control group (p=0.01, number
needed to treat (NNT)=21). Use of the Sentinel[supreg] Cerebral
Protection System device was associated with a 2.2 percent absolute
risk reduction in mortality with NNT=45. Composite endpoint of major
adverse cardiac and cerebrovascular events (MACCE) was found in 2.1
percent of those patients undergoing a TAVR procedure with the use of
the Sentinel[supreg] Cerebral Protection System device versus 7.9
percent in the control group (p=0.01). Therefore, we believe the data
provided by the applicant showing reduced mortality and stroke within 7
days of a TAVR procedure as compared to patients undergoing a TAVR
procedure without a cerebral protection device demonstrate that the
Sentinel[supreg] Cerebral Protection System represents a substantial
clinical improvement.
After consideration of the public comments we received, we have
determined that the Sentinel[supreg] Cerebral Protection System meets
all of the criteria for approval for new technology add-on payments.
Therefore, we are approving new technology add-on payments for the
Sentinel[supreg] Cerebral Protection System for FY 2019. Cases
involving the use of the Sentinel[supreg] Cerebral Protection System
that are eligible for new technology add-on payments will be identified
by ICD-10-PCS procedure code X2A5312. In its application, the applicant
estimated that the cost of the Sentinel[supreg] Cerebral Protection
System is $2,400. Under Sec. 412.88(a)(2), we limit new technology
add-on payments 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 a case involving the use of the Sentinel[supreg] Cerebral
Protection System is $1,400 for FY 2019.
i. The AquaBeam System (Aquablation)
PROCEPT BioRobotics Corporation submitted an application for new
technology add-on payments for the AquaBeam System (Aquablation) for FY
2019. According to the applicant, the AquaBeam System is indicated for
the use in the treatment of patients experiencing lower urinary tract
symptoms caused by a diagnosis of benign prostatic hyperplasia (BPH).
The AquaBeam System consists of three main components: a console with
two high-pressure pumps, a conformal surgical planning unit with trans-
rectal ultrasound imaging, and a single-use robotic hand-piece.
The applicant reported that The AquaBeam System provides the
operating surgeon a multi-dimensional view, using both ultrasound image
guidance and endoscopic visualization, to clearly identify the
prostatic adenoma and plan the surgical resection area. Based on the
planning inputs from the surgeon, the system's robot delivers
Aquablation, an autonomous waterjet ablation therapy that enables
targeted, controlled, heat-free and immediate removal of prostate
tissue used for the purpose of treating lower urinary tract symptoms
caused by a diagnosis of BPH. The combination of surgical mapping and
robotically-controlled resection of the prostate is designed to offer
predictable and reproducible outcomes, independent of prostate size,
prostate shape or surgeon experience.
In its application, the applicant indicated that benign prostatic
hyperplasia (BPH) is one of the most commonly diagnosed conditions of
the male genitourinary tract \174\ and is defined as the ``. . .
enlargement of the prostate due to benign growth of glandular tissue .
. .'' in older men.\175\ BPH is estimated to affect 30 percent of males
that are older than 50 years old.\176\ \177\ BPH may compress the
urethral canal possibly obstructing the urethra, which may cause
symptoms that effect the lower urinary tract, such as difficulty
urinating (dysuria), hesitancy, and frequent urination.\178\ \179\
\180\
---------------------------------------------------------------------------
\174\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\175\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
\176\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\177\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\178\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\179\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\180\ Roehrborn, C., Gilling, P., Cher, D., and Templin, B.,
``The WATER Study (Waterjet Ablation Therapy for Ednoscopic
Resection of prostate tissue),'' Redwood City: PROCEPT BioRobotics
Corporation, 2017.
---------------------------------------------------------------------------
The initial treatment for a patient who has been diagnosed with BPH
is watchful waiting and medications.\181\ Symptom severity, as measured
by one test, the International Prostate Symptom Score (IPSS), is the
primary measure by which surgery necessity is decided.\182\
[[Page 41349]]
Many techniques exist for the surgical treatment of patients who have
been diagnosed with BPH, and these surgical treatments differ primarily
by the method of resection: electrocautery in the case of Transurethral
Resection of the Prostate (TURP), laser enucleation, plasma
vaporization, photoselective vaporization, radiofrequency ablation,
microwave thermotherapy, and transurethral incision \183\ are among the
primary methods. TURP is the primary reference treatment for patients
who have been diagnosed with BPH.\184\ \185\ \186\ \187\ \188\.
---------------------------------------------------------------------------
\181\ Ibid.
\182\ Cunningham, G.R., Kadmon, D., 2017, ``Clinical
manifestations and diagnostic evaluation of benign prostatic
hyperplasia,'' 2017. Available at: https://www.uptodate.com/
contents/clinical-manifestations-and-diagnostic-evaluation-of-
benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\183\ Ibid.
\184\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\185\ Cunningham, G.R., Kadmon, D.,''Clinical manifestations and
diagnostic evaluation of benign prostatic hyperplasia,'' 2017.
Available at: https://www.uptodate.com/contents/clinical-
manifestations-and-diagnostic-evaluation-of-benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\186\ Mamoulakis, C., Efthimiou, I., Kazoulis, S.,
Christoulakis, I., and Sofras, F., ``The Modified Clavien
Classification System: A standardized platform for reporting
complications in transurethral resection of the prostate,'' World
Journal of Urology, 2011, vol. 29, pp. 205-210.
\187\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\188\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
---------------------------------------------------------------------------
According to the applicant, while the TURP procedure achieves
alleviation of the symptoms that affect the lower urinary tract
associated with a diagnosis of BPH, morbidity rates caused by adverse
events are high following the procedure. The TURP procedure has a well-
documented history of associated adverse effects, such as hematuria,
clot retention, bladder wall injury, hyponatremia, bladder neck
contracture, urinary incontinence, and retrograde
ejaculation.189 190 191 192 193 The likelihood of both
adverse events and long-term morbidity related to the TURP procedure
increase with the size of the prostate.\194\
---------------------------------------------------------------------------
\189\ Roehrborn, C., Gilling, P., Cher, D., and Templin, B.,
``The WATER Study (Waterjet Ablation Therapy for Ednoscopic
Resection of prostate tissue), Redwood City: PROCEPT BioRobotics
Corporation, 2017.
\190\ Cunningham, G.R., & Kadmon, D., 2017, ``Clinical
manifestations and diagnostic evaluation of benign prostatic
hyperplasia,'' 2017. Available at: https://www.uptodate.com/
contents/clinical-manifestations-and-diagnostic-evaluation-of-
benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\191\ Mamoulakis, C., Efthimiou, I., Kazoulis, S.,
Christoulakis, I., Sofras, F., ``The Modified Clavien Classification
System: A standardized platform for reporting complications in
transurethral resection of the prostate,'' World Journal of Urology,
2011, vol. 29, pp. 205-210.
\192\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\193\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\194\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
---------------------------------------------------------------------------
The applicant asserted that the AquaBeam System provides superior
safety outcomes as compared to the TURP procedure, while providing non-
inferior efficacy in treating the symptoms that affect the lower
urinary tract associated with a diagnosis of BPH. The applicant further
stated that the AquaBeam System yields consistent and predictable
procedure and resection times regardless of the size and shape of the
prostate and the surgeon's experience. Lastly, according to the
applicant, the AquaBeam System provides increased efficacy and safety
for larger prostates as compared to the TURP procedure.
With respect to the newness criterion, FDA granted the applicant's
De Novo request on December 21, 2017, for use in the resection and
removal of prostate tissue in males suffering from lower urinary tract
symptoms (LUTS) due to benign prostatic hyperplasia. The applicant
stated that the AquaBeam System was made available on the U.S. market
immediately after the FDA granted the De Novo request. Therefore, we
stated in the proposed rule that if approved for new technology add-on
payments, the newness period is considered to begin on December 21,
2017. CMS has approved the use of ICD-10-PCS code XV508A4 (Destruction
of prostate using robotic waterjet ablation, via natural or artificial
opening endoscopic, new technology group 4), effective October 1, 2018,
to uniquely identify procedures involving the AquaBeam System.
As discussed earlier, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for the purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant stated that the AquaBeam System is the first technology to
deliver treatment to patients who have been diagnosed with BPH for the
symptoms that effect the lower urinary tract caused by BPH via
Aquablation therapy. The AquaBeam System utilizes intra-operative image
guidance for surgical planning and then Aquablation therapy to
robotically resect tissue utilizing a high-velocity waterjet. According
to the applicant, all other BPH treatment procedures only utilize
cystoscopic visualization, whereas the AquaBeam System utilizes
Aquablation therapy, a combination of cystoscopic visualization and
intra-operative image guidance. According to the applicant, the
AquaBeam System's use of Aquablation therapy qualifies it as the only
technology to utilize a high-velocity room temperature waterjet for
tissue resection, while most other BPH surgical procedures utilize
thermal energy to resect prostatic tissue, or require the implantation
of clips to pull back prostatic tissue blocking the urethra. Lastly,
according to the applicant, all other surgical modalities are executed
by the operating surgeon, while the AquaBeam System allows planning by
the surgeon and utilization of Aquablation therapy ensures accurate and
efficient tissue resection is autonomously executed by the robot.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that potential
cases representing potential patients who may be eligible for treatment
involving the AquaBeam System's Aquablation therapy technique will
ultimately map to the same MS-DRGs as cases for existing BPH treatment
options.
With respect to the third criterion, 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, the applicant
[[Page 41350]]
stated that the AquaBeam System's Aquablation therapy will ultimately
treat the same patient population as other available BPH treatment
options. The applicant asserted that the AquaBeam System's Aquablation
therapy has been shown to be more effective and safer than the TURP
procedure for patients with larger prostate sizes. The applicant stated
that prostates 80 ml or greater in size are not appropriate for the
TURP procedure and, therefore, more intensive procedures such as
surgery are required. Furthermore, the applicant claimed that the
AquaBeam System's Aquablation therapy is particularly appropriate for
smaller prostate sizes, ~30 ml, due to increased accuracy provided by
both the computer assistance and ultrasound visualization.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20346), we stated
we had the following concerns regarding whether the AQUABEAM System
meets the newness criterion. Currently, there are many treatment
options that utilize varying forms of ablation, such as mono and
bipolar TURP procedures, laser, microwave, and radiofrequency, to treat
the symptoms associated with a diagnosis of BPH. We stated that we were
concerned that, while this device utilizes water to perform any tissue
removal, its mechanism of action may not be different from that of
other forms of treatment for patients who have been diagnosed with BPH.
Further, the use of water to perform tissue removal in the treatment of
associated symptoms in patients who have been diagnosed with BPH has
existed in other areas of surgical treatment prior to the introduction
of this product (for example, endometrial ablation and wound
debridement). In addition, the standard operative treatment, such as
with the TURP procedure, for patients who have been diagnosed with BPH
is to widen the urethra compressed by an enlarged prostate in an effort
to alleviate the negative effects of an enlarged prostate. Like other
existing methods, the AQUABEAM System's Aquablation therapy also
ablates tissue to relieve compression of the urethra. Additionally,
while the robotic arm and computer programing may result in different
outcomes for patients, we stated we were uncertain that the use of the
robotic hand and computer programming result in a new mechanism of
action. We invited public comments on this issue.
We also invited public comments on whether the AQUABEAM System's
Aquablation therapy is substantially similar to existing technologies
and whether it meets the newness criterion.
Comment: The applicant stated in regard to the beginning of the
newness period that, while the AQUABEAM System received approval from
the FDA for its De Novo request on December 21, 2017, local non-
coverage determinations in the Medicare population resulted in the
first case being delayed until April 19, 2018. Therefore, the applicant
believed that the beginning date of the newness period should begin on
April 9, 2018, instead of the date FDA granted the De Novo request.
Response: With regard to the beginning of the technology's newness
period, as discussed in the FY 2005 IPPS final rule (69 FR 49003), the
timeframe that a new technology can be eligible to receive new
technology add-on payments begins when data begin to become available.
While local non-coverage determinations may limit the use of a
technology in different regions in the country, a technology may be
available in regions where no local non-coverage decision existed (with
data beginning to become available). Additionally, similar to the
discussion in the FY 2006 IPPS final rule (70 FR 47349), we do not
consider how frequently the medical service or technology has been used
in the Medicare population in our determination of newness. We welcome
further information from the applicant for consideration in future
rulemaking regarding the beginning of the newness period.
Comment: The applicant reiterated in response to CMS' concerns
regarding the mechanism of action of the AquaBeam System that it is
novel because of: (1) The real-time multi-dimensional imaging which
enables improved clinical decision-making and personalized treatment
planning; (2) the accuracy of the autonomous robotic hand piece which
autonomously executes the surgeon's treatment plan for controlled and
precise tissue removal; and (3) the heat free submerged waterjet used
to resect prostatic tissue which avoids the possibility of
complications arising from thermal injury, and that these qualities
result in consistently safe and effective outcomes for patients and
greatly reduced chances of side effects when compared to TURP and
further provide a minimally invasive transurethral alternative to open
prostatectomy (OP) in large prostates. The applicant further indicated
that each of the three components, individually, are unique to existing
BPH surgical options and the combination of the three further
represents the novelty of the technology's mechanism of action in the
treatment of BPH.
The applicant also believed that CMS' concerns that the use of
water to perform tissue removal may not be different than other forms
of tissue removal in treating BPH, the use of water has been used in
other areas such as endometrial ablation and wound debridement, and
there is uncertainty that the use of a robotic hand and computer
programming result in a new mechanism of action reflect a broad
interpretation of mechanism of action. The applicant stated that the
notion that all ablation techniques are similar ignores the fact that
ablation is used to treat a variety of illnesses and conditions
throughout the body using a variety of technological approaches with
varying effectiveness. The applicant reiterated that it believed the
three mechanisms of action of the AquaBeam System are unique in
prostate treatment when compared to all other existing prostate
treatments, and the AquaBeam System is the only ablation technique that
utilizes room-temperature water whereas other ablative approaches such
as TURP, laser vaporization (PVP), laser resection (HoLEP/ThuLEP),
microwave necrosis (TUMT), and mechanical radio-frequency resection
(open simple prostatectomy) utilize heat as the primary mechanism of
action. The applicant explained that the waterjet mechanism of action
has the advantage of sparing sensitive tissues around the prostate like
the bladder neck, verumontanum, and nerve and vascular tissues, whereas
other ablative approaches are tissue agnostic. The applicant also
disagreed with CMS' comparison of Aquablation therapy to wound
debridement and tissue dissection because the surgical goals are
different. The applicant stated that, in the application of wound
debridement the surgical goal is wound cleansing and debris removal
using a waterjet, and in tissue dissection, the goal is tissue
separation or disassociating the parenchymal connective tissue. The
applicant further stated, in contrast, the goal of all BPH surgical
procedures is to remove excessive prostatic tissue. The applicant
reiterated that the use of the robotic handpiece and computer
programming is the essence of the AquaBeam System to deliver
Aquablation therapy, and these components allow the surgeon to
visualize the prostate in a way that was previously unavailable in BPH
surgery to precisely determine the specific prostatic tissue to resect,
which is not possible with existing technologies. The applicant further
indicated that the
[[Page 41351]]
robotic handpiece autonomously executes the tissue resection, which has
been clinically shown to provide consistent results, regardless of the
prostate size or surgeon experience. The applicant believed that this
differs from other treatment modalities, which rely on surgeon
experience that introduces more variability into the procedure. The
applicant stated that the robotic handpiece also facilitates the use of
a minimally invasive transurethral approach to treat large prostates in
which the vast majority of other transurethral technologies are not
recommended.
The applicant also stated that CMS has not historically applied
such a broad definition when defining and evaluating mechanism of
action, as in example, for new technology add-on payments for the
INTUITY and Perceval valves that are aortic valve replacements that
share the surgical goal of providing the patient with a functioning
aortic valve. The applicant noted that, CMS determined the mechanisms
of action of the INTUITY and Perceval valves in achieving the surgical
goal were not substantially similar to treatments that were available
at the time, and both technologies were approved for new technology
add-on payments. In addition, the applicant stated that drug-coated
balloons (a new combination of existing balloon and existing drugs)
have a surgical goal similar to non-drug coated balloons of creating a
lumen in the artery, and CMS determined that the drug-coated balloons
used a different mechanism of action and similarly approved both
applications for new technology add-on payments. The applicant
explained that, in the case of Aquablation therapy, the surgical goal
is similar to other BPH technologies in creating an opening in the
prostatic urethra. However, the applicant indicated, as described
above, the mechanism of action is different from any other technologies
currently available. The applicant believed that, applying the same
criterion as applied in the historical examples, the AquaBeam System
meets the criteria for approval of new technology add-on payments.
The applicant also stated that for large prostates, the MS-DRG
assignment for potential cases representing patients eligible for
treatment involving the AquaBeam System would be similar to normal
transurethral prostate treatments, which is different than the MS-DRG
assignment for open prostatectomy (OP). The applicant believed that
potential cases involving Aquablation therapy would group to MS-DRGs
713 and 714 (Transurethral Prostatectomy) and open simple prostatectomy
procedures would group to MS-DRGs 707 and 708 (Major Male Pelvic
Procedures). The applicant stated that, for prostates sized less than
80 ml, potential cases involving Aquablation therapy would map to the
same MS-DRGs as other transurethral procedures, and for large prostates
greater than 80 ml in size, procedures involving Aquablation therapy in
lieu of an open prostatectomy would result in a different MS-DRG
assignment. Therefore, the applicant believed AquaBeam System's
Aquablation therapy meets this criterion under substantial similarity.
Other commenters believed that the AquaBeam System met the newness
criterion. The commenters stated that the use of imaging and
ultrasound, the autonomous robotic execution of the procedure, and the
use of room temperature water rather than heat, combined make the
AquaBeam System a novel treatment for BPH. Another commenter further
indicated that many other technologies are surgeon- and experience-
dependent, whereas the AquaBeam System's image guided procedure with
robotic execution allows for a greater degree of precision and
monitoring of the treatment independent of experience or expertise. The
commenter believed that the addition of image guidance and robotic
execution of the procedure leads to consistent results independent of
surgeon experience.
Response: We appreciate the commenters' input. After consideration
of these comments, we agree that the AquaBeam System has a unique
mechanism of action because it is the first to use waterjet ablation
therapy that enables targeted, controlled, heat-free and immediate
removal of prostate tissue used for the purpose of treating lower
urinary tract symptoms caused by a diagnosis of BPH. Therefore, after
consideration of the public comments we received, we agree that the
AquaBeam System meets the newness criterion and the newness period
beginning date is April 19, 2018.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that the technology meets the cost
criterion. Given that at the time of the analysis, the AquaBeam
System's Aquablation therapy procedure did not have a unique ICD-10-PCS
procedure code, the applicant searched the FY 2016 MedPAR data file for
cases with the following current ICD-10-PCS codes describing other BPH
minimally invasive procedures to identify potential cases representing
potential patients who may be eligible for treatment involving the
AquaBeam System's Aquablation therapy: 0V507ZZ (Destruction of
prostate, via natural or artificial opening), 0V508ZZ (Destruction of
prostate, via natural or artificial opening endoscopic), 0VT07ZZ
(Resection of prostate, via natural or artificial opening), and 0VT08ZZ
(Resection of prostate, via natural or artificial opening endoscopic).
The applicant identified a total of 133 MS-DRGs using these ICD-10-PCS
codes.
In order to calculate the standardized charges per case, the
applicant conducted two analyses, based on 100 percent and 75 percent
of identified claims in the FY 2016 MedPAR data file. The applicant
based its analysis on 100 percent of claims mapping to 133 MS-DRGs, and
75 percent of claims mapping to 6 MS-DRGs. The cases identified in the
75 percent analysis mapped to MS-DRGs 665 (Prostatectomy with MCC), 666
(Prostatectomy with CC), 667 (Prostatectomy without CC/MCC), 713
(Transurethral Prostatectomy with CC/MCC), 714 (Transurethral
Prostatectomy without CC/MCC), and 988 (Non-Extensive O.R. Procedures
Unrelated to Principal Diagnosis with CC). In situations in which there
were fewer than 11 cases for individual MS-DRGs in the MedPAR data
file, a value of 11 was imputed to ensure confidentiality for patients.
When evaluating 100 percent of the cases identified, the applicant
included low-volume MS-DRGs that had equal to or less than 11 total
cases to represent potential patients who may be eligible for treatment
involving the AquaBeam System's Aquablation therapy in order to
calculate the average case-weighted unstandardized and standardized
charge amounts. The 75 percent analysis removed those MS-DRGs with 11
cases or less representing potential patients who may be eligible for
treatment involving the AquaBeam System's Aquablation therapy,
resulting in only 6 of the 133 MS-DRGs remaining for analysis. A total
of 8,449 cases were included in the 100 percent analysis and 6,285
cases were included in the 75 percent analysis.
Using the 100 percent and 75 percent samples, the applicant
determined that the average case-weighted unstandardized charge per
case was $69,662 and $47,475, respectively. The applicant removed 100
percent of total charges associated with the service category
``Medical/Surgical Supply Charge Amount'' (which includes revenue
centers 027x and 062x) because the applicant believed that it was the
most conservative choice, as this
[[Page 41352]]
amount varies by MS-DRG. The applicant stated that the financial impact
of utilizing the AquaBeam System's Aquablation therapy on hospital
resources other than on ``Medical Supplies'' is unknown at this time.
Therefore, a value of $0 was used for charges related to the prior
technology.
The applicant standardized the charges, and inflated the charges
using an inflation factor of 1.09357, from the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38524). The applicant then added the charges for the
new technology. The applicant computed a final inflated average case-
weighted standardized charge per case of $69,588 for the 100 percent
sample, and $51,022 for the 75 percent sample. The average case-
weighted threshold amount was $59,242 for the 100 percent sample, and
$48,893 for the 75 percent sample. Because the final inflated average
case-weighted standardized charge per case exceeded the average case-
weighted threshold amount for both analyses, the applicant maintained
that the technology met the cost criterion.
We invited public comment regarding whether the technology meets
the cost criterion.
Comment: The applicant reiterated the results of the cost analysis
detailed in the FY 2019 IPPS/LTCH PPS proposed rule, and believed that
the AquaBeam System meets the cost criterion.
Response: We appreciate the applicant's input and agree that the
AquaBeam System meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the Aquablation therapy provided by the
AquaBeam System represents a substantial clinical improvement over
existing treatment options for symptoms associated with the lower
urinary tract for patients who have been diagnosed with BPH.
Specifically, the applicant stated that the AquaBeam System's
Aquablation therapy provides superior safety outcomes compared to the
TURP procedure, while providing non-inferior efficacy in treating the
symptoms that effect the lower urinary tract associated with a
diagnosis of BPH; the AquaBeam System's delivery of Aquablation therapy
yields consistent and predictable procedure and resection times
regardless of the size and shape of the prostate or the surgeon's
experience; and the AquaBeam System's Aquablation therapy demonstrated
superior efficacy and safety for larger prostates (that is, prostates
sized 50 to 80 ml) as compared to the TURP procedure.
The applicant provided the results of one Phase I and one Phase II
trial published articles, the WATER Study Clinical Study Report, and a
meta-analysis of current treatments with its application as evidence
for the substantial clinical improvement criterion.
According to the applicant, the first study \195\ enrolled 15
nonrandomized patients with a prostate volume between 25 to 80 ml in a
Phase I trial testing the safety and feasibility of the AquaBeam
System's Aquablation therapy; all patients received the AquaBeam
System's Aquablation therapy. This study, a prospective, nonrandomized
study, enrolled men who were 50 to 80 years old who were affected by
moderate to severe lower urinary tract symptoms, who did not respond to
standard medical therapy.\196\ Follow-up assessments were conducted at
1, 3, and 6 months and included information on adverse events, serum
PSA level, uroflowmetry, PVR, quality of life, and the International
Prostate Symptom Score (IPSS) and International Index of Erectile
Function (IIEF) scores. The primary outcome was the assessment of
safety as measured by adverse event reporting; secondary endpoints
focused on alleviation of BPH symptoms.\197\
---------------------------------------------------------------------------
\195\ Gilling, P., Reuther, R., Kahokehr, A., Fraundorfer, M.,
``Aquablation--Image-guided Robot-assisted Waterjet Ablation of the
Prostate: Initial clinical experience,'' British Journal of Urology
International, 2016, vol. 117, pp. 923-929.
\196\ Ibid.
\197\ Ibid.
---------------------------------------------------------------------------
The applicant indicated that 8 of the 15 patients who were enrolled
in the trial had at least 1 procedure-related adverse event (for
example, catheterization, hematuria, dysuria, pelvic pain, bladder
spasms), which the authors reported to be consistent with outcomes from
minimally-invasive transurethral procedures.\198\ There were no
occurrences of incontinence, retrograde ejaculation, or erectile
dysfunction at 30 days.\199\ Statistically significant improvement on
all outcomes occurred over the 6-month period. Average IPSS scores
showed a negative slope with scores of 23.1, 11.8, 9.1, and 8.6 for
baseline, 1 month, 3 months, and 6 months (p<0.01 in all cases).
Average quality of life scores, which range from 1 to 5, where 1 is
better and 5 is worse, decreased from 5.0 at baseline to 2.6 at 1
month, 2.2 at 3 months, and 2.5 at 6 months. Average maximum urinary
flow rate increased steadily across time points from 8.6 ml/s at
baseline to 18.6 ml/s at 6 months. Lastly, average post-void residual
urine volume decreased from 91 ml at baseline to 38 ml at 1 month, 60
ml at 3 months, and 30 ml at 6 months.\200\
---------------------------------------------------------------------------
\198\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
\199\ Ibid.
\200\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
---------------------------------------------------------------------------
The second study \201\ presents results from a Phase II trial
involving 21 men with a prostate volume between 30 to 102 ml who
received treatment involving the AquaBeam System's Aquablation therapy
with follow-up at 1 year. This prospective study enrolled men between
the ages of 50 and 80 years old who were effected by moderate to severe
symptomatic BPH.\202\ The primary end point was the rate of adverse
events; the secondary end points measured alleviation of symptoms
associated with a diagnosis of BPH. Data was collected at baseline and
at 1 month, 3 months, 6 months, and 12 months; 1 patient withdrew at 3
months. The authors asserted that the occurrence of post-operative
adverse events (urinary retention, dysuria, hematuria, urinary tract
infection, bladder spasm, meatal stenosis) were consistent with other
minimally-invasive transurethral procedures; \203\ 6 patients had at
least 1 adverse event, including temporary urinary symptoms and
medically-treated urinary tract infections.\204\ The mean IPSS scores
decreased from the baseline of 22.8 with 11.5 at 1 month, 7 at 3
months, 7.1 at 6 months, and 6.8 at 12 months and were statistically
significantly different. Similarly, quality of life decreased from a
mean score of 5 at baseline to 1.7 at 12 months, all time points were
statistically significantly different from the baseline.
---------------------------------------------------------------------------
\201\ Ibid.
\202\ Ibid.
\203\ Ibid.
\204\ Ibid.
---------------------------------------------------------------------------
The third document provided by the applicant is the Clinical Study
Report: WATER Study,\205\ a prospective multi-center, randomized,
blinded study. The WATER Study compared the AquaBeam System's
Aquablation therapy to the TURP procedure for the treatment of lower
urinary tract symptoms associated with a diagnosis of BPH. One hundred
eighty one (181) patients with prostate volumes between 30 and 80 ml
were randomized, 65 patients to the TURP procedure group and the other
116 to
[[Page 41353]]
the AquaBeam System's Aquablation therapy group, with 176 (97 percent
of patients) continuing at 3 and 6 month follow-up, where 2 missing
patients received treatment involving the AquaBeam System's Aquablation
therapy and 3 received treatment involving the TURP procedure;
randomization efficacy was assessed and confirmed with findings of no
statistical differences between cases and controls among all
characteristics measures, specifically prostate volume. Two primary
endpoints were identified: (1) The safety endpoint was the proportion
of patients with adverse events rates as ``probably or definitely
related to the study procedure'' also classified as the Clavien-Dindo
(CD) Grade 2 or higher or any Grade 1 resulting in persistent
disability; and (2) the primary efficacy endpoint was a change in the
IPSS score from baseline to 6 months. Three secondary endpoints were
based on perioperative data and were: length of hospital stay, length
of operative time, and length of resection time. The occurrences of
three secondary endpoints during the 6-month follow-up were: (1)
Reoperation or reintervention within 6 months; (2) evaluation of
proportion of sexually active patients; and (3) evaluation of
proportion of patients with major adverse urologic events.
---------------------------------------------------------------------------
\205\ Roehrborn, C., Gilling, P., Cher, D., Templin, B., ``The
WATER Study (Waterjet Ablation Therapy for Ednoscopic Resection of
prostate tissue),'' Redwood City: PROCEPT BioRobotics Corporation,
2017.
---------------------------------------------------------------------------
At 3 months, 25 percent of the patients in the AquaBeam System's
Aquablation therapy group and 40 percent of the patients in the TURP
group had an adverse event. The difference of -15 percent has a 95
percent confidence interval of -29.2 and -1.0 percent. At 6 months,
25.9 percent of the patients in the AquaBeam System's Aquablation
therapy group and 43.1 percent of the patients in the TURP group had an
adverse event. The difference of -17 percent has a 95 percent
confidence interval of -31.5 to -3.0 percent. An analysis of safety
events classified with the CD system as possibly, probably or
definitely related to the procedure resulted in a CD Grade 1 persistent
event difference between -17.7 percent (favoring the AquaBeam System's
Aquablation therapy) with 95 percent confidence interval of -30.1 to -
7.2 percent and a CD Grade 2 or higher event difference of -3.3 percent
with 95 percent confidence interval of -16.5 to 8.7 percent.
The applicant indicated that the primary efficacy endpoint was
assessed by a change in IPSS score over time. While change in score and
change in percentages are generally higher for the AquaBeam System's
Aquablation therapy, no statistically significant differences occurred
between the AquaBeam System's Aquablation therapy and the TURP
procedure over time. For example, the AquaBeam System's Aquablation
therapy group experienced changes in IPSS mean score by visit of 0, -
3.8, -12.5, -16.0, and -16.9 at baseline, 1 week, 1 month, 3 months,
and 6 months, respectively, while the TURP group had mean scores of 0,
-3.6, -11.1, -14.6, and -15.1 at baseline, 1 week, 1 month, 3 months,
and 6 months, respectively.
Lastly, the applicant indicated that secondary endpoints were
assessed. A mean length of stay for both the AquaBeam System's
Aquablation therapy and the TURP procedure groups of 1.4 was achieved.
While the mean operative times were similar, the hand piece in and out
time was statistically significantly shorter for the AquaBeam System's
Aquablation therapy group at 23.3 minutes as compared to 34.2 in the
TURP procedure group. The mean resection time was 23 minutes shorter
for the AquaBeam System's Aquablation therapy group at 3.9 minutes. No
statistically significant difference was seen between the AquaBeam
System's Aquablation therapy and the TURP procedure groups on the
outcomes of re-intervention and worsening sexual function; 32.9 percent
of the AquaBeam System's Aquablation therapy group had worsening sexual
function as compared to 52.8 percent of the TURP procedure group. While
statistically significant differences occurred across groups for change
in ejaculatory function, the difference no longer remained at 6 months.
While a greater proportion of the TURP procedure group patients
experienced a negative change in erectile function as compared to the
AquaBeam System's Aquablation therapy group patients (10 percent versus
6.2 percent at 6 months), no statistically significant differences
occurred. No statistically significant differences between groups
occurred for major adverse urologic events.
The applicant provided a meta-analysis of landmark studies
regarding typical treatments for patients who have been diagnosed with
BPH in order to provide supporting evidence for the assertion of
superior outcomes achieved with the use of the AquaBeam System's
Aquablation therapy. The applicant cited four ``landmark clinical
trials,'' which report on the AquaBeam System's Aquablation
therapy,\206\ the TURP procedure, Green light laser versus the TURP
procedure,\207\ and Urolift.\208\ Comparisons are made between
performance outcomes on three separate treatments for patients who have
been diagnosed with BPH: the AquaBeam System's Aquablation therapy, the
TURP procedure, and Urolift. The applicant stated that all three
clinical trials included men with average IPSS baseline scores of 21 to
23 points. The applicant stated that, while total procedure times are
similar across all three treatment options, the AquaBeam System's
Aquablation therapy has dramatically less time and variability
associated with the tissue treatment. The applicant further stated that
the differences between treatment options were not assessed for
statistical significance. The applicant indicated that the AquaBeam
System's Aquablation therapy, with an approximate score of 17, had the
largest improvement in IPSS scores at 6 months as compared to 16 for
the TURP procedure and 11 for Urolift. Compared to 46 percent in the
TURP group, the applicant found that the AquaBeam System's Aquablation
therapy and Urolift had much lower percentages, 4 percent and 0
percent, respectively, of an ejaculation-related consequence in
patients. Lastly, the applicant stated that safety events, as measured
by the percentage of CD Grade 2 or higher events, were lower in the
AquaBeam System's Aquablation therapy (19 percent) and Urolift (14
percent) than in TURP (29 percent).
---------------------------------------------------------------------------
\206\ Roehrborn, C., Gilling, P., Cher, D., Templin, B., ``The
WATER Study (Waterjet Ablation Therapy for Ednoscopic Resection of
prostate tissue),'' Redwood City: PROCEPT BioRobotics Corporation,
2017.
\207\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\208\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
---------------------------------------------------------------------------
In the FY 2019 IPPS/LTCH proposed rule (83 FR 20349), we stated
that we have several concerns related to the substantial clinical
improvement criterion. The applicant performed a meta-analysis
comparing results from three separate studies, which tested the effects
of three separate treatment options. According to the applicant, the
results provided consistently show the AquaBeam System's Aquablation
therapy and Urolift as being superior to the standard treatment of the
TURP procedure. In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR
20349), we stated we have concerns with the
[[Page 41354]]
interpretation of these results that the applicant provided. We noted
that the comparison of multiple clinical studies is a difficult issue,
and it was not clear if the applicant took into account the varying
study designs, sample techniques, and other study specific issues, such
as physician skill and patient health status. For instance, the
applicant stated that a comparison of Urolift and the AquaBeam System's
Aquablation therapy may not be appropriate due to the differing
indications of the procedures; the applicant indicated that Urolift is
primarily used for the treatment of patients who have been diagnosed
with BPH who have smaller prostate volumes, whereas the AquaBeam
System's Aquablation therapy procedure may be used in all prostate
sizes. Similarly, the applicant stated that the TURP procedure is
generally not utilized in patients with prostates larger than 80 ml,
whereas such patients may be eligible for treatment involving the
AquaBeam System's Aquablation therapy.
We noted that the applicant submitted a meta-analysis in an effort
to compare currently available therapies to the AquaBeam System's
Aquablation therapy. We stated that the possibility of the
heterogeneity of samples and methods across studies leads to the
possible introduction of bias, which results in the difficulty or
inability to distinguish between bias and actual outcomes. We invited
public comments on the applicability of this meta-analysis.
Comment: The applicant stated in response to CMS' concerns in
regard to the meta-analysis that the meta-analysis was performed with
the cited studies because of the similarities in geography where
enrolled, inclusion of similar prostate size (30 to 80 ml), and the
randomization against the same control of TURP. The applicant indicated
that the objective of the analysis was to compare the reduced safety
profile in ejaculatory dysfunction of Aquablation therapy compared to
TURP as demonstrated in the WATER study, as well as to compare the
safety profile of Aquablation therapy to the UroLift procedure.
Response: We appreciate the applicant's response and have taken
this new information into consideration in making a final
determination, as indicated below.
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20349), we
indicated that we had a concern that the differences between the
AquaBeam System's Aquablation therapy and standard treatment options
may not be as impactful and confined to safety aspects. We stated that
it appears that the data on efficacy supported the equivalence of the
AquaBeam System's Aquablation therapy and the TURP procedure based upon
noninferiority analysis. In the proposed rule, we stated we agree with
the applicant that the safety data were reported as showing superiority
of the AquaBeam System's Aquablation therapy over the TURP procedure,
although the data were difficult to track because adverse consequences
were combined into categories; the AquaBeam System's Aquablation
therapy was reportedly better in terms of ejaculatory function. It was
noted in the application that, while the AquaBeam System's Aquablation
therapy was statistically superior to the TURP procedure in the CD
Grade 1 + adverse events, it was not statistically different in the CD
Grade 2 or greater category. The applicant stated that regardless of
the method, the urethra is typically used as the means for performing
the BPH treatment procedure, which necessarily increases the likelihood
of CD Grade 2 adverse events in all transurethral procedures.
In addition, the applicant noted that the treatment option may
depend on the size of the prostate. The applicant stated that the
AquaBeam System's Aquablation therapy is appropriate for small and
large prostate sizes as a BPH treatment procedure. The AquaBeam
System's Aquablation therapy has been shown to have limited positive
outcomes as compared to the TURP procedure for prostates sized greater
than 50 grams to 80 grams in each of the studies provided by the
applicant. However, the applicant noted that the TURP procedure would
not be used for prostates larger than 80 grams in size. Therefore, we
stated in the proposed rule that we believe that another proper
comparator for the AquaBeam System's Aquablation therapy may be laser
or radical/open surgical procedures given their respective indication
for small and large prostate sizes.
Lastly, the applicant compared AquaBeam System's Aquablation
therapy and the standard of care TURP procedure to support a finding of
improved safety. We stated that there are other treatment modalities
available that may have a similar safety profile as the AquaBeam
System's Aquablation therapy and we are interested in information that
compares the AquaBeam System's Aquablation therapy to other treatment
modalities.
We invited public comments on whether the AquaBeam System's
Aquablation therapy meets the substantial clinical improvement
criterion.
Comment: In response to CMS' concerns from the proposed rule that,
while the WATER safety data showed superiority, adverse consequences
were difficult to track because the data were combined into a composite
endpoint, the applicant explained that in the WATER study a CD1+ event
was defined as involving persistent bladder spasms, bleeding, dysuria,
pain, retrograde ejaculation, urethral damage, urinary retention,
urinary tract infection, and urinary urgency/frequency/difficulty/
leakage. The applicant stated that data from the WATER study show
Aquablation therapy was statistically superior to TURP in CD Grade 1+
adverse events. The applicant indicated that CD2 and above events are
defined as those requiring pharmacological treatment, blood
transfusions, endoscopic, surgical, or radiological interventions. The
applicant stated that, after removal of the ejaculatory dysfunction
events from the composite safety endpoint, the rate of CD2 and above
adverse events for Aquablation therapy as compared to TURP was 19.8
percent and 23.1 percent, respectively.
In response to CMS' concern with regard to the WATER study finding
of Aquablation's improved safety relative to TURP and that other
treatment modalities demonstrate safety profiles similar to
Aquablation, the applicant stated that, while this may be true,
treatment modalities such as TUIP, TUNA/RF, Microwave, and PUL have
inferior efficacy to TURP in a variety of objective and subjective
measures including peak urine flow, PVR reduction and BPH symptom
reduction.\209\ However, the applicant indicated that, because the
WATER study showed Aquablation efficacy similar to TURP for all
prostate sizes and superiority in prostates sized 50 to 80 ml in
volume, and that TURP shows superior efficacy to these other treatment
modalities, Aquablation therapy offers an overall clinical improvement
relative to these alternative treatment modalities.
---------------------------------------------------------------------------
\209\ Christidis, D., McGrath, S., Perera, M., Manning, T.,
Bolton, D., & Lawrentschuk, N., ``Minimally invasive surgical
therapies for benign prostatic hypertrophy: The rise in minimally
invasive surgical therapies,'' Prostate International, 2017, pp. 41-
46.
---------------------------------------------------------------------------
In response to CMS' concern that Aquablation has limited positive
outcomes for prostates sized 50 to 80 ml, the applicant stated that in
a pre-specified subgroup analysis the WATER study showed superior
safety and efficacy in prostates sized 50 to 80 ml
[[Page 41355]]
compared to TURP. The applicant indicated that, in fact, because the
subset analysis of men with prostates sized 50 to 80 ml in volume
demonstrated Aquablation's superior outcomes over the TURP arm of the
WATER study, the applicant sought to assess the efficacy and safety of
the procedure in men with even larger prostates in the follow up WATER
II study, which included prostates in sizes greater than 80 ml.
In response to CMS' concern that Aquablation therapy performed on
larger prostates should be compared with laser (that is, HoLEP) and
open simple prostatectomy procedures, the applicant stated that between
September and December 2017, 101 men (67 percent were Medicare
eligible) with moderate-to-severe BPH symptoms and prostates sized 80
to 150 ml in volume underwent Aquablation therapy in the prospective
multi-center international WATER II clinical trial. The applicant
indicated that, as noted above, the American Urological Association
(AUA) BPH surgical guidelines recommend open simple prostatectomy or
laser enucleation for the treatment of large prostates (>80 ml in
volume). The applicant explained that the primary purpose of the WATER
II was to assess the safety profile for Aquablation therapy in larger
prostates. The applicant stated that the overall CD Grades 2, 3, and 4
complications were recorded in 19 percent, 11 percent, and 5 percent,
respectively.\210\ The applicant further stated that postoperative
bleeding after Aquablation therapy that required transfusion (N=6, 5.9
percent) and/or cystoscopy with clot evacuation/fulguration (N=2, 2.0
percent) was observed in 8 patients during the procedural
hospitalization.\211\ The applicant stated that these results compare
favorably to simple prostatectomy because the severe hemorrhage rate
(defined as patients with a diagnosis related to hemorrhage and those
who underwent transfusion) has been reported as high as 29 percent
(range 12 to 29 percent) based on a claims analysis of 35,171 patients
\212\ who underwent the procedure. The applicant stated that
Aquablation therapy has an average length of stay of 1.6 days compared
to an average length of state of 5 days for prostatectomy. The
applicant further indicated that transfusion rates for the AquaBeam
System were less than those for the simple prostatectomy procedure. The
applicant explained that the AquaBeam procedure is technically feasible
even for surgeons with low or no prior experience, and open
prostatectomy has higher morbidity rates, longer hospital stays, and
longer catheter times than those for the AquaBeam System.
---------------------------------------------------------------------------
\210\ Mihir, D., Bidar, M., Bhojani, N., Trainer, A., Arther,
A., Kramolowsky, E., Doumanian, L., et al., ``WATER II (80-150 mL)
Procedureal Outcomes,'' 2018, BJU International.
\211\ Ibid.
\212\ Pariser, J., Pearce, S., Patel, S., & Bales, G.,
``National Trends of Simple Prostatectomy for Benign Prostatic
Hyperplasia with and Analysis of Risk Factors for Adverse
Perioperative Outcomes,'' 2015, Urology, vol. 86(4).
---------------------------------------------------------------------------
In response to CMS' concern regarding the appropriateness of the
AquaBeam System for prostates of smaller sizes (for example, <30 mls),
the applicant apologized for any inference in its application regarding
smaller prostate sizes because it was not its intention to make any
specific claims regarding smaller prostates.
Other commenters also believed that the AquaBeam System represented
a substantial clinical improvement. Another commenter stated that all
of its treated patients experienced improved urinary flow and decreased
BPH symptoms following treatment with the AquaBeam System. The
commenter further stated that treated patients appreciated the
preservation of ejaculatory function and indicated they would undergo
the procedure again. Two commenters summarized results from the WATER
II study, a single-arm study of the AquaBeam System in patients
diagnosed with BPH with >80 ml prostate volumes, and stated that the
AquaBeam System decreases operative time, time under anesthesia,
decreases the length of inpatient stays, and has fewer complications as
compared to open prostatectomy, which is the standard treatment for
large prostates greater than 80 ml in volume. Another commenter with an
interest in providing the AquaBeam therapy at its facility stated that,
if an adequate payment is provided for the therapy, increased volume
will most likely reduce the cost of this method of treatment.
Response: We appreciate the additional information provided by the
applicant and the commenters' input. We agree that the results of the
WATER study are statistically significant (95 percent confidence
interval of the difference between AquaBeam and TURP) and superior to
TURP in safety as evidenced by a lower proportion of persistent CD
Grade 1 adverse events at 3 months (which measured in totality Bladder
spasm, Bleeding, Dysuria, Pain, Retrograde ejaculation, Urethral
damage, Urinary retention, Urinary tract infection, Urinary urgency/
frequency/difficulty/leakage). Additionally, patients enrolled in the
WATER study with prostate sizes greater than 50 ml in volume and
treated with Aquablation therapy had superior IPSS improvement than
those treated with TURP, as well as better peak urinary flow rates
(Qmax) at 6 months, and improved ejaculatory function and incontinence
scores at 3 months. Results from the WATER II study for patients with
large prostate volumes demonstrate better outcomes of the AquaBeam
System over the standard-of-care, the open prostatectomy, regarding
less operative time, decreased length of stay, and decreased rates of
severe hemorrhage and transfusions. Based on the results above, we have
determined the AquaBeam System represents a substantial clinical
improvement for the resection and removal of prostate tissue in males
suffering from lower urinary tract symptoms due to benign prostatic
hyperplasia.
After consideration of the public comments we received, we have
determined that the AquaBeam System's Aquablation therapy meets all of
the criteria for approval of new technology add-on payments. Therefore,
we are approving new technology add-on payments for the AquaBeam System
for FY 2019. Cases involving the AquaBeam System that are eligible for
new technology add-on payments will be identified by ICD-10-PCS
procedure code XV508A4 (Destruction of prostate using robotic waterjet
ablation, via natural or artificial opening endoscopic, new technology
group 4).
In its application, the applicant estimated that the average
Medicare beneficiary would require the transurethral procedure of one
AQUABEAM System per patient. According to the application, the cost of
the AQUABEAM System is $2,500 per procedure. Under Sec. 412.88(a)(2),
we limit new technology add-on payments 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 a case involving the use of the AQUABEAM
System's Aquablation System is $1,250 for FY 2019. In accordance with
the current indication for the AQUABEAM System, CMS expects that the
AQUABEAM System will be used in the treatment for adult patients
experiencing lower urinary tract symptoms caused by a diagnosis of BPH.
j. AndexXaTM (Andexanet alfa)
Portola Pharmaceuticals, Inc. (Portola) submitted an application
for new technology add-on payments for FY 2019 for the use of
AndexXaTM (Andexanet alfa). (We note that the
[[Page 41356]]
applicant previously submitted applications for new technology add-on
payments for FY 2017 and FY 2018 for Andexanet alfa, which were
withdrawn). In the proposed rule, we discussed AndexXaTM as
a reversal agent for patients treated with direct and indirect Factor
Xa inhibitors when reversal of anticoagulation is needed due to life-
threatening or uncontrolled bleeding. AndexXaTM received FDA
approval on May 3, 2018, and is indicated for use in the treatment of
patients treated with rivaroxaban and apixaban, when reversal of
anticoagulation is needed due to life-threatening or uncontrolled
bleeding. According to the FDA-approved prescribing information,
AndexXaTM has not been shown to be effective for, and is not
indicated for, the treatment of bleeding related to any Factor Xa
inhibitors other than the direct Factor Xa inhibitors apixaban and
rivaroxaban. Therefore, in this final rule, we discuss
AndexXaTM in the context of the FDA-approved indication as a
treatment of an anticoagulation reversal agent for rivaroxaban and
apixaban only due to life-threatening or uncontrolled bleeding.
AndexXaTM is an antidote used to treat patients who are
receiving treatment with the Factor Xa inhibitors rivaroxaban and
apixaban when reversal of anticoagulation is needed due to life-
threatening or uncontrolled bleeding. Patients at high risk for
thrombosis, including those who have been diagnosed with atrial
fibrillation (AF) and venous thrombosis (VTE), typically receive
treatment using long-term oral anticoagulation agents. Factor Xa
inhibitors are oral anticoagulants used to prevent stroke and systemic
embolism in patients who have been diagnosed with AF. These oral
anticoagulants are also used to treat patients who have been diagnosed
with deep-vein thrombosis (DVT) and its complications, pulmonary
embolism (PE), and patients who have undergone knee, hip, or abdominal
surgery. Rivarobaxan (Xarelto[supreg]), apixaban (Eliquis[supreg]),
betrixaban (Bevyxxa[supreg]), and edoxaban (Savaysa[supreg]) are
included in the new class of Factor Xa inhibitors, and are often
referred to as ``novel oral anticoagulants'' (NOACs) or ``non-vitamin K
antagonist oral anticoagulants.'' Although these anticoagulants have
been commercially available since 2011, prior to May 3, 2018, there was
no FDA-approved therapy used for the urgent reversal of Factor Xa
inhibitors rivarobaxan and apixaban as a result of serious bleeding
episodes.
As stated above, AndexXaTM received FDA approval on May
3, 2018, and is indicated for use in the treatment of patients treated
with rivaroxaban and apixaban, when reversal of anticoagulation is
needed due to life-threatening or uncontrolled bleeding. The applicant
received approval for two unique ICD-10-PCS procedure codes that became
effective October 1, 2016 (FY 2017). The approved ICD-10-PCS procedure
codes are: XW03372 (Introduction of Andexanet alfa, Factor Xa inhibitor
reversal agent into peripheral vein, percutaneous approach, new
technology group 2); and XW04372 (Introduction of Andexanet alfa,
Factor Xa inhibitor reversal agent into central vein, percutaneous
approach, new technology group 2).
With regard to the ``newness'' criterion, as discussed earlier, if
a technology meets all three of the substantial similarity 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. AndexXaTM is the first and the only antidote
available to treat patients receiving apixaban and rivaroxaban who
suffer a major bleeding episode and require urgent reversal of
anticoagulation. Other anticoagulant reversal agents, such as
KcentraTM and idarucizumab, do not reverse the effects of
apixaban and rivaroxaban. Therefore, the applicant asserted that the
technology is not substantially similar to any other currently approved
and available treatment options for Medicare beneficiaries. We
discussed the applicant's assertions in the context of the three
substantial similarity criteria in the proposed rule, as also discussed
below.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant indicated that AndexXaTM is the first
anticoagulant reversal agent that binds to apixaban and rivaroxaban
with high affinity, thereby sequestering the inhibitors and
consequently rapidly reducing free plasma concentration of these Factor
Xa inhibitors. The applicant asserted that this mechanism of action
neutralizes the inhibitors' anticoagulant effect, which allows for the
restoration of normal hemostasis. According to the applicant,
AndexXaTM represents a significant therapeutic advance
because it provides rapid reversal of the anticoagulation effect of
apixaban and rivaroxaban in the event of a serious bleeding episode
where other anticoagulant reversal agents, such as KcentraTM
and idarucizumab, do not reverse the effects of these Factor Xa
inhibitors.
With regard to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that
AndexXaTM is the first FDA-approved anticoagulant reversal
agent for patients receiving rivaroxaban and apixaban, and the first
reversal agent to be FDA-approved for these Factor Xa inhibitors. The
applicant further stated that other anticoagulant reversal agents, such
as KcentraTM and idarucizumab, do not reverse the effects of
these Factor Xa inhibitors. Therefore, the MS-DRGs do not contain cases
that represent patients who have been treated with any anticoagulant
reversal agents for these Factor Xa inhibitors.
With regard to the third criterion, 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, the applicant
indicated that AndexXaTM is the only anticoagulant reversal
agent available for treating patients who are receiving treatment with
apixaban or rivaroxaban who experience serious, uncontrolled bleeding
events or who require emergency surgery. Therefore, the applicant
believed that AndexXaTM would be the first type of treatment
option available to this patient population. As a result, we stated in
the proposed rule that we believe that it appears that
AndexXaTM is not substantially similar to any existing
technologies. We invited public comments on whether
AndexXaTM meets the substantial similarity criteria, and
whether AndexXaTM meets the newness criterion.
Comment: The applicant reiterated that AndexXaTM
satisfies the newness criterion. With respect to mechanism of action,
the applicant reiterated that AndexXaTM rapidly binds to
apixaban and rivaroxaban with high affinity, acting as a decoy molecule
that sequesters the inhibitors to rapidly reduce the free plasma
concentrations and neutralize their antiacoagulant effects to allow
restoration of normal hemostasis. With respect to treating the same or
similar type of disease and the same or similar patient population, the
applicant further indicated that, as the first and only FDA-approved
antidote available for a patient population receiving treatment using
apixaban or rivaroxaban who suffer a major bleeding episode and require
urgent reversal of direct Factor Xa coagulation of these Factor Xa
inhibitors, AndexXaTM is not substantially similar to any
other currently approved and available treatment options for Medicare
[[Page 41357]]
beneficiaries. The applicant emphasized that, prior to the approval of
AndexXaTM, the management of bleeding events in patients
taking the Factor Xa inhibitors apixaban and rivaroxaban had been
predicated on blood transfusions (that is, whole blood, packed red
blood cells (RBCs), fresh frozen plasma (FFP), and/or platelets), or
the use of a number of replacement clotting factor therapies (for
example, fresh frozen plasma, Prothrombin Complex Concentrates (PCC),
and recombinant activated Factor VIIa)--all of which are supportive
measures that do not reverse the Factor Xa activity of these
inhibitors. Finally, with respect to MS-DRG assignment, because
AndexXaTM is the first and only FDA-approved reversal agent
of Factor Xa inhibitor for the treatment of patients receiving apixaban
and rivaroxaban who experience life-threatening or uncontrolled
bleeding or require emergency surgery, and the first reversal agent to
be approved for these Factor Xa inhibitors, the applicant believed that
the MS-DRGs do not contain any cases that represent patients treated
with AndexXaTM as a reversal agent for these Factor Xa
inhibitors.
Other commenters stated that AndexXaTM meets the newness
criterion and is not substantially similar to any existing technologies
because there is no other reversal agent available on the U.S. market
for patients who are being treated with these Factor Xa inhibitors and
experience severe bleeding. These commenters stated that other
anticoagulant reversal agents do not reverse the effects of these
Factor Xa inhibitors.
Response: We appreciate the commenters' and the applicant's input
on whether AndexXaTM meets the newness criterion. After
review of the information provided by the applicant and consideration
of the public comments we received, we believe that
AndexXaTM meets the newness criterion and consider the
beginning of the technology's newness period to be May 3, 2018, when
the technology received FDA approval.
With regard to the cost criterion, we stated in the proposed rule
that the applicant researched the FY 2015 MedPAR claims data file for
potential cases representing patients who may be eligible for treatment
using AndexXaTM. The applicant used three sets of ICD-9-CM
codes to identify these cases: (1) Codes identifying potential cases
representing patients who were treated with an anticoagulant and,
therefore, who are at risk of bleeding; (2) codes identifying potential
cases representing patients with a history of conditions that were
treated with Factor Xa inhibitors; and (3) codes identifying potential
cases representing patients who experienced bleeding episodes as the
reason for the current admission. The applicant included with its
application the following table displaying a complete list of ICD-9-CM
codes that met its selection criteria.
------------------------------------------------------------------------
ICD-9-CM codes applicable Applicable ICD-9-CM code description
------------------------------------------------------------------------
V12.50.................... Personal history of unspecified circulatory
disease.
V12.51.................... Personal history of venous thrombosis and
embolism.
V12.52.................... Personal history of thrombophlebitis.
V12.54.................... Personal history of transient ischemic
attack (TIA), and cerebral infarction
without residual deficits.
V12.55.................... Personal history of pulmonary embolism.
V12.59.................... Personal history of other diseases of
circulatory system.
V43.64.................... Hip joint replacement.
V43.65.................... Knee joint replacement.
V58.43.................... Aftercare following surgery for injury and
trauma.
V58.49.................... Other specified aftercare following surgery.
V58.73.................... Aftercare following surgery of the
circulatory system, NEC.
V58.75.................... Aftercare following surgery of the teeth,
oral cavity and digestive system, NEC.
V58.61.................... Long-term (current) use of anticoagulants.
E934.2.................... Anticoagulants causing adverse effects in
therapeutic use.
99.00..................... Perioperative autologous transfusion of
whole blood or blood components.
99.01..................... Exchange transfusion.
99.02..................... Transfusion of previously collected
autologous blood.
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.
------------------------------------------------------------------------
The applicant identified a total of 51,605 potential cases that
mapped to 683 MS- DRGs, resulting in an average case-weighted charge
per case of $72,291. The applicant also provided an analysis that was
limited to cases representing 80 percent of all potential cases
identified (41,255 cases) that mapped to the top 151 MS-DRGs. Under
this analysis, the average case-weighted charge per case was $69,020.
The applicant provided a third analysis that was limited to cases
representing 25 percent of all potential cases identified (12,873
cases) that mapped to the top 9 MS-DRGs. This third analysis resulted
in an average case-weighted charge per case of $46,974.
Under each of these analyses, the applicant also provided
sensitivity analyses based on variables representing two areas of
uncertainty: (1) Whether to remove 40 percent or 60 percent of blood
and blood administration charges; and (2) whether to remove pharmacy
charges based on the ceiling price of factor eight inhibitor bypass
activity (FEIBA), a branded anti-inhibitor coagulant complex, or on the
pharmacy indicator 5 (PI5) in the MedPAR data file, which correlates to
potential cases utilizing generic coagulation factors. Overall, the
applicant conducted twelve sensitivity analyses, and provided the
following rationales:
The applicant chose to remove 40 percent and 60 percent of
blood and blood administration charges because potential patients who
may be eligible for treatment using AndexXaTM for Factor Xa
reversal may still require blood and blood products to treat other
conditions. Therefore, the applicant believed that it would be
inappropriate to remove all of the charges associated with blood and
blood administration because all of the charges cannot be attributed to
Factor Xa reversal. The
[[Page 41358]]
applicant maintained that the amounts of blood and blood products
required for treatment vary according to the severity of the bleeding.
Therefore, the applicant stated that the use of AndexXaTM
may replace 60 percent of blood and blood product administration
charges for potential cases with less severity of bleeding, but only 40
percent of charges for potential cases with more severe bleeding.
The applicant maintained that FEIBA is the highest priced
clotting factor used for Factor Xa inhibitor reversal, and it is
unlikely that pharmacy charges for Factor Xa reversal would exceed the
FEIBA ceiling price of $2,642. Therefore, the applicant capped the
charges to be removed at $2,642 to exclude charges unrelated to the
reversal of Factor Xa anticoagulation. The applicant also considered an
alternative scenario in which charges associated with pharmacy
indicator 5 (PI5) were removed from the costs of potential cases that
included this indicator in the MedPAR data. On average, charges removed
from the costs of potential cases utilizing generic coagulation factors
were much lower than the total pharmacy charges.
The applicant noted that, in all 12 scenarios, the average case-
weighted standardized charge per case for potential cases representing
patients who may be eligible for treatment using AndexXa